(VNDA) 2022 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Q4 2022 Vanda Pharmaceuticals Inc. Earnings Conference Call. I would now like to turn the call over to Kevin Moran, Vanda's Chief Financial Officer. Please go ahead.

女士們，先生們，感謝你們的支持，歡迎來到 2022 年第四季度 Vanda Pharmaceuticals Inc. 收益電話會議。我現在想把電話轉給 Vanda 的首席財務官凱文莫蘭。請繼續。

Thank you, Mandy. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' Fourth Quarter and Full Year 2022 Performance. Our fourth quarter and full year 2022 results were released this afternoon and are available on the SEC's EDGAR system and on our website, www.vandapharma.com.

謝謝你，曼迪。下午好，感謝您加入我們討論 Vanda Pharmaceuticals 第四季度和 2022 年全年業績。我們的第四季度和 2022 年全年業績於今天下午發布，可在 SEC 的 EDGAR 系統和我們的網站 www.vandapharma.com 上查閱。

In addition, we are providing live and archived versions of this conference call on our website. 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.

此外，我們還在我們的網站上提供了本次電話會議的實時和存檔版本。和我一起參加今天電話會議的是我們的總裁、首席執行官兼董事會主席 Mihael Polymeropoulos 博士；和我們的總法律顧問蒂姆·威廉姆斯 (Tim Williams)。

Following my introductory remarks, Mihael will update you on our ongoing activities. I will then comment on our financial results before opening the lines for your questions.

在我的介紹性發言之後，Mihael 將向您介紹我們正在進行的活動的最新情況。然後，在開始回答您的問題之前，我將對我們的財務結果發表評論。

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. 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.

在我們繼續之前，我想提醒大家，我們在本次電話會議上所做的各種聲明將是聯邦證券法意義上的前瞻性聲明。我們的前瞻性陳述基於當前的預期和假設，涉及風險、環境變化和不確定性。這些風險在我們最近的 10-K 表年度報告中關於前瞻性陳述、風險因素和管理層對財務狀況和經營業績的討論和分析部分的警示性說明中有所描述，並由我們隨後的 10 表季度報告更新-Q，有關 8-K 表格的當前報告和向 SEC 提交的其他文件，可在 SEC 的 EDGAR 系統和我們的網站上找到。

We encourage all investors to read these reports and our other filings. 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.

我們鼓勵所有投資者閱讀這些報告和我們的其他文件。我們在本次電話會議上提供的信息僅截至今天，我們沒有義務公開更新或修改我們可能根據新信息、未來事件或其他原因在本次電話會議上做出的任何前瞻性陳述，除非要求法律。

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

話雖如此，我現在想把電話轉給我們的首席執行官 Mihael Polymeropoulos 博士。

Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us to discuss Vanda's Fourth Quarter and Full Year 2022 Results. I will first discuss key highlights from our clinical programs and then I will ask our General Counsel, Tim Williams, to provide a brief update on litigation matters before turning the call over to Kevin to discuss our commercial progress and financial results.

非常感謝，凱文，大家下午好。感謝您加入我們討論 Vanda 的第四季度和 2022 年全年業績。我將首先討論我們臨床項目的主要亮點，然後我將請我們的總法律顧問 Tim Williams 簡要介紹訴訟事宜，然後再將電話轉給 Kevin 討論我們的商業進展和財務結果。

I will begin with our announcement of positive results in the Phase III clinical study of Fanapt in the treatment of bipolar I disorder in adult patients. This was a large placebo-controlled study conducted in the U.S. and Europe that enrolled approximately 400 patients with acute episodes of bipolar I disorder. The primary endpoint of that study was measured in week 4 of treatment and it was assessed by the Young Mania Rating Scale, YMRS, a rating scale of clinical severity in the core symptoms of Mania.

首先，我將宣布 Fanapt 治療成人雙相 I 型障礙的 III 期臨床研究的積極結果。這是一項在美國和歐洲進行的大型安慰劑對照研究，招募了大約 400 名 I 型雙相情感障礙急性發作患者。該研究的主要終點是在治療的第 4 週進行測量，並通過 Young Mania 評定量表 (YMRS) 進行評估，YMRS 是一種評定躁狂核心症狀臨床嚴重程度的評定量表。

At the end of the study, week 4, Fanapt's patients saw a large improvement on placebo-treated patients and this difference was highly statistically significant. YMRS was assessed at end of weeks 1, 2, 3 and 4. Statistically significant benefit in the Fanapt group over placebo was observed as early as week 2 of treatment. Consistent with the total YMRS score, the individual YMRS subscale items also showed improvement in the Fanapt group versus the placebo group over the course of the 4-week study.

在研究結束時，即第 4 週，Fanapt 的患者比接受安慰劑治療的患者有很大改善，這種差異具有高度統計學意義。 YMRS 在第 1、2、3 和 4 週結束時進行評估。早在治療的第 2 週就觀察到 Fanapt 組優於安慰劑的統計學顯著益處。與 YMRS 總分一致，在為期 4 週的研究過程中，個別 YMRS 子量表項目也顯示 Fanapt 組與安慰劑組相比有所改善。

Other outcomes such as clinical global impression of severity and clinical global impression of Change also achieved high statistical significance. We plan to submit a supplemental new drug application, sNDA, for Fanapt for the treatment of acute manic and mixed episodes associated with bipolar I disorder in adults in the first half of this year, 2023.

其他結果，如嚴重程度的臨床總體印象和變化的臨床總體印像也具有很高的統計學意義。我們計劃在今年上半年，即 2023 年提交 Fanapt 的補充新藥申請 sNDA ，用於治療成人 I 型雙相情感障礙相關的急性躁狂和混合發作。

As a reminder, bipolar disorder is estimated to affect 2.8% of the U.S. adult population, a number approximately up to 10x higher than the estimated prevalence of schizophrenia. Therefore, an indication of bipolar disorder presents a substantial opportunity to expand the Fanapt franchise above and beyond the already approved indication of schizophrenia in adults.

提醒一下，據估計雙相情感障礙會影響 2.8% 的美國成年人口，這個數字大約比精神分裂症的估計患病率高出 10 倍。因此，雙相情感障礙的適應症提供了一個重要的機會，可以擴大 Fanapt 特許經營權，使其超越已經批准的成人精神分裂症適應症。

We also reported results for VQW-765, a Novel alpha-7 nicotinic acetylcholine receptor partial agonist from clinical study 2201 in the treatment of acute performance anxiety in social situations. In Study 2201, participants who receive VQW-765 showed numerically lower stress levels compared to those who received placebo. The stress level was assessed by the subjective units of distress scale, SUDS, a self-rating scaled level of nervousness or distress ranging from 0 to 100 at multiple time points during the duration of the [TSST] test.

我們還報告了 VQW-765 的結果，這是一種來自臨床研究 2201 的新型 alpha-7 菸鹼型乙酰膽鹼受體部分激動劑，用於治療社交場合的急性表現焦慮。在研究 2201 中，與接受安慰劑的參與者相比，接受 VQW-765 的參與者在數值上表現出較低的壓力水平。壓力水平是通過痛苦量表的主觀單位 SUDS 評估的，SUDS 是在 [TSST] 測試期間的多個時間點的緊張或痛苦的自評量表水平，範圍從 0 到 100。

In particular, in female participants, approximately 70% of the total participants, a larger magnitude of effect was observed, which was also statistically significant. This is the first time that the alpha-7 nicotinic acetylcholine receptor partial agonist has shown efficacy in a clinical study of performance anxiety, and we look forward to confirming the efficacy in future studies.

特別是，在女性參與者中，約佔參與者總數的 70%，觀察到更大程度的影響，這在統計學上也很顯著。這是α-7菸鹼型乙酰膽鹼受體部分激動劑首次在表現焦慮的臨床研究中顯示療效，我們期待在未來的研究中證實療效。

On tradipitant, preparation of the new drug application in GI, in gastroparesis is ongoing, with an expected FDA submission in the first half of 2023. Additionally, an open label study of tradipitant in patients with gastroparesis is ongoing with the first 400 patients having already completed this 12-week study. Patients continue to seek access to the Expanded Access Program with a number of patients having been treated with tradipitant for over a year.

關於 tradipitant，新藥在 GI 和胃輕癱中的應用準備工作正在進行中，預計將於 2023 年上半年提交 FDA。此外，一項針對胃輕癱患者的 tradipitant 開放標籤研究正在進行中，前 400 名患者已經完成了這項為期 12 週的研究。患者繼續尋求獲得擴展訪問計劃的機會，許多患者已經接受了一年多的 trapitant 治療。

For tradipitant for the treatment of motion sickness, enrollment in the clinical program is over 75% complete, and we expect results by mid-2023. We've experienced great success in recruitment as a result of target advertising, some of which you may have seen during Sunday football and other sporting events.

對於治療暈動病的 trapitant，臨床項目的註冊已完成 75% 以上，我們預計到 2023 年年中會有結果。由於目標廣告，我們在招聘方面取得了巨大成功，您可能在周日足球和其他體育賽事中看到過其中一些廣告。

On HETLIOZ, we continue to pursue regulatory approvals for HETLIOZ in the indications of insomnia and jet lag disorder, supported by robust clinical program results that we have previously reported.

在 HETLIOZ 上，我們繼續尋求 HETLIOZ 在失眠和時差障礙適應症方面的監管批准，並得到我們之前報告的穩健臨床計劃結果的支持。

We look forward to bringing our clinical programs to successful completion in pursuit of regulatory filings and approvals. As we reported today, 2022 was another successful year commercializing HETLIOZ for Non-24 in SMS and Fanapt for schizophrenia. The adverse decision in December by the District Court on the HETLIOZ ANDA litigation poses a significant challenge, but we remain focused and determined in asserting our patents.

我們期待著成功完成我們的臨床項目，以爭取監管備案和批准。正如我們今天報導的那樣，2022 年是將 HETLIOZ 商業化用於非 24 歲 SMS 和 Fanapt 用於精神分裂症的又一個成功年份。地方法院於 12 月對 HETLIOZ ANDA 訴訟作出的不利裁決構成了重大挑戰，但我們仍然專注並堅定地主張我們的專利。

I will now turn the call to Tim Williams, our General Counsel, to discuss this and other legal matters. Tim?

我現在將把電話轉給我們的總法律顧問蒂姆·威廉姆斯 (Tim Williams)，討論這個問題和其他法律問題。蒂姆？

Thank you, Mihael. As you probably know, in December, the Delaware District Court found certain of our HETLIOZ patent claims invalid or not infringed by the generic defendants in our ANDA litigation. We appealed that ruling and we have a hearing at the Federal Circuit scheduled for March 14. We expect the decision by the court after that hearing.

謝謝你，米哈埃爾。您可能知道，在 12 月，特拉華州地方法院裁定我們的某些 HETLIOZ 專利權利要求無效或未被我們的 ANDA 訴訟中的仿製藥被告侵權。我們對該裁決提出上訴，並定於 3 月 14 日在聯邦巡迴法院舉行聽證會。我們期待法院在聽證會後作出裁決。

Teva Pharmaceuticals has since launched a generic version of tasimelteon, and we have brought several actions against Teva based on problematic aspects of that launch, including infringement of other HETLIOZ patents, (inaudible) violations, and patient safety issues, to name a few. These are separate and distinct cases from our Federal Circuit appeal, but are nonetheless important to protect the safety of patients and to protect Vanda's legal rights.

此後，Teva Pharmaceuticals 推出了他司美瓊的仿製藥，我們已根據該上市的問題方面對 Teva 提起多項訴訟，包括侵犯其他 HETLIOZ 專利、（聽不清）侵權和患者安全問題，僅舉幾例。這些案件與我們的聯邦巡迴上訴法院的上訴不同，但對於保護患者安全和保護 Vanda 的合法權利來說仍然很重要。

As an example, we discovered that Teva's generic tasimelteon is sold without braille labeling, which presents an immediate risk to blind HETLIOZ users who are accustomed to the braille labeling, packaging, and safety information that is accompanied HETLIOZ since its launch. To address this concern, we filed a citizen's petition with the FDA and filed Sutent Federal Court requesting immediate action from the FDA.

例如，我們發現 Teva 的仿製藥他司美瓊在銷售時沒有盲文標籤，這給盲人 HETLIOZ 用戶帶來了直接風險，他們已經習慣了 HETLIOZ 自上市以來隨附的盲文標籤、包裝和安全信息。為解決這一問題，我們向 FDA 提交了一份公民請願書，並向 Sutent 聯邦法院提交申請，要求 FDA 立即採取行動。

On the regulatory front, we continue to pursue multiple actions against the FDA on a variety of regulatory matters in an effort to continue to hold the FDA accountable to law. We intend to continue this legation to protect the interest of Vanda and to make our products more broadly available to the patients we serve. Mihael?

在監管方面，我們繼續就各種監管事項對 FDA 採取多項行動，以繼續讓 FDA 對法律負責。我們打算繼續這一使命，以保護 Vanda 的利益，並使我們的產品更廣泛地提供給我們所服務的患者。米哈爾？

Thank you very much, Tim. I will turn now the call to Kevin Moran to discuss our commercial progress and financial results. Kevin?

非常感謝你，蒂姆。我現在將把電話轉給凱文莫蘭，討論我們的商業進展和財務結果。凱文？

Thank you, Mihael. I'll begin by summarizing our full year 2022 financial results before turning to discuss the fourth quarter of 2022. Total revenues for the full year 2022 were $254.4 million, a 5% decrease compared to $268.7 million for the same period in 2021. HETLIOZ net product sales of $159.7 million were the primary contributor and driver of our 2022 revenues and saw an 8% decrease compared to 2021. The year-over-year decline in the HETLIOZ business reflects continued reimbursement challenges for prescriptions for patients with Non-24. Fanapt net product sales of $94.7 million for the full year 2022 were essentially flat compared to 2021.

謝謝你，米哈埃爾。我將首先總結我們 2022 年全年的財務業績，然後再討論 2022 年第四季度。2022 年全年的總收入為 2.544 億美元，與 2021 年同期的 2.687 億美元相比下降了 5%。HETLIOZ net 1.597 億美元的產品銷售額是我們 2022 年收入的主要貢獻者和推動力，與 2021 年相比下降了 8%。HETLIOZ 業務的同比下降反映了非 24 歲患者處方藥的持續報銷挑戰。 Fanapt 2022 年全年淨產品銷售額為 9470 萬美元，與 2021 年基本持平。

For the full year 2022, Vanda recorded net income of $6.3 million compared to net income of $33.2 million for 2021. Net income for the full year 2022 included an income tax provision of $5 million as compared to an income tax provision of $9.2 million for 2021. Vanda's cash, cash equivalents and marketable securities, referred to as cash, as of December 31, 2022, were $466.9 million representing an increase of $34 million as compared to December 31, 2021.

2022 年全年，Vanda 的淨收入為 630 萬美元，而 2021 年的淨收入為 3320 萬美元。2022 年全年的淨收入包括 500 萬美元的所得稅撥備，而 2021 年的所得稅撥備為 920 萬美元截至2022年12月31日，中聯的現金、現金等價物和有價證券（簡稱現金）為4.669億美元，較2021年12月31日增加3400萬美元。

Turning now to our quarterly results. Total revenues for the fourth quarter of 2022 were $64.5 million, a 5% decrease compared to $68 million for the fourth quarter of 2021. HETLIOZ net product sales were $40.1 million for the fourth quarter of 2022, a 9% decrease compared to $44.1 million in the fourth quarter of 2021.

現在轉向我們的季度業績。 2022年第四季度總收入為6450萬美元，與2021年第四季度的6800萬美元相比下降5%。HETLIOZ 2022年第四季度產品淨銷售額為4010萬美元，與2021年第四季度的4410萬美元相比下降9%。 2021 年第四季度。

Consistent with the full year of 2022, net sales for the fourth quarter reflect the continued reimbursement challenges for prescriptions for patients with Non-24. Fanapt net product sales in the fourth quarter of 2022 were $24.4 million, a 2% increase compared to $24 million in the fourth quarter of 2021. Fanapt net product sales in the fourth quarter of 2022 increased by 2% as compared to $24 million in the third quarter of 2022. Fanapt prescriptions in the fourth quarter of 2022, as reported by IQVIA Xponent, decreased by approximately 2% compared to the third quarter of 2022. For the fourth quarter of 2022, Vanda recorded net income of $6.9 million compared to net income of $7.1 million for the fourth quarter of 2021.

與 2022 年全年一致，第四季度的淨銷售額反映了非 24 歲患者處方藥的持續報銷挑戰。 Fanapt 2022 年第四季度產品淨銷售額為 2440 萬美元，較 2021 年第四季度的 2400 萬美元增長 2%。Fanapt 2022 年第四季度產品淨銷售額較上年同期的 2400 萬美元增長 2% 2022 年第三季度。根據 IQVIA Xponent 的報告，2022 年第四季度的 Fanapt 處方藥與 2022 年第三季度相比下降了約 2%。2022 年第四季度，中聯達錄得的淨收入為 690 萬美元，與淨收入相比2021 年第四季度的收入為 710 萬美元。

The net income for the fourth quarter of 2022 included an income tax provision of $2.8 million as compared to an income tax provision of $1.5 million for the same period in 2021. Operating expenses in the fourth quarter of 2022 were $57.9 million compared to $59.4 million in the fourth quarter of 2021. The $1.5 million decrease was primarily driven by lower R&D expenses related to the late-stage Fanapt development program.

2022 年第四季度的淨收入包括 280 萬美元的所得稅準備金，而 2021 年同期的所得稅準備金為 150 萬美元。2022 年第四季度的營業費用為 5790 萬美元，而 2022 年第四季度的營業費用為 5940 萬美元2021 年第四季度。150 萬美元的減少主要是由於與後期 Fanapt 開發計劃相關的研發費用減少所致。

Operating expenses in the fourth quarter of 2022 decreased by $3.6 million as compared to $61.4 million in the third quarter of 2022. This decrease was primarily driven by lower R&D expenses related to the late-stage Fanapt development program and our previously announced OliPass agreement, partially offset by higher SG&A expenses related to spending for ongoing litigation.

與 2022 年第三季度的 6140 萬美元相比，2022 年第四季度的運營費用減少了 360 萬美元。減少的主要原因是與後期 Fanapt 開發計劃和我們之前宣布的 OliPass 協議相關的研發費用減少，部分原因是被與正在進行的訴訟支出相關的更高的 SG&A 費用所抵消。

As a reminder, a $3 million upfront fee was expensed in the third quarter of 2022 upon entering into the OliPass agreement.

提醒一下，在簽訂 OliPass 協議後，2022 年第三季度支付了 300 萬美元的預付費用。

Given uncertainty surrounding the U.S. market for HETLIOZ for the treatment of Non-24 as a result of the ongoing HETLIOZ patent litigation, Vanda is unable to provide 2023 financial guidance at this time. Vanda will continue to evaluate its ability to provide financial guidance as the year progresses.

鑑於正在進行的 HETLIOZ 專利訴訟導致 HETLIOZ 在美國市場治療非 24 歲患者的不確定性，中聯目前無法提供 2023 年的財務指導。隨著時間的推移，中聯將繼續評估其提供財務指導的能力。

With that, I'll now turn the call back to Mihael.

有了這個，我現在將電話轉回給 Mihael。

Thank you very much, Kevin. At this point, we'll be happy to answer any questions you may have.

非常感謝你，凱文。此時，我們很樂意回答您的任何問題。

(Operator Instructions) There are no questions at this time. I would now like to turn the call over to Vanda Pharmaceuticals management for closing remarks.

（操作員說明）目前沒有問題。我現在想把電話轉給 Vanda Pharmaceuticals 管理層作結束語。

Thank you very much, everybody, for joining us on this quarterly call, and we look forward to discussing our progress in the future. Thank you.

非常感謝大家參加這個季度電話會議，我們期待著討論我們未來的進展。謝謝。

Thank you, ladies and gentlemen. This does conclude today's call. Thank you for your participation. You may now disconnect.

謝謝你們，女士們，先生們。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。