(VNDA) 2022 Q3 法說會逐字稿

Good afternoon. My name is Emma and I will be your conference operator today. At this time, I would like to welcome everyone to the Vanda Pharmaceuticals Third Quarter 2022 Earnings Conference Call. (Operator Instructions). I would now like to hand the call over to Kevin Moran, Vanda's Chief Financial Officer. Kevin, you may begin your conference.

下午好。我叫艾瑪，今天我將擔任你們的會議接線員。此時，歡迎大家參加中聯藥業2022年第三季度財報電話會議。 （操作員說明）。我現在想把電話轉給 Vanda 的首席財務官凱文莫蘭。凱文，你可以開始你的會議了。

Thank you, Emma. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' third-quarter 2022 performance. Our third quarter 2022 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. Joining me on today's call is Dr. Mihales Polymeropoulos, our President, Chief Executive Officer and Chairman of the Board. Additionally, we have Tim Williams, our General Counsel; and Gunther Birznieks, our Senior Vice President of Business Development and R&D Committee member. Following my introductory remarks, Mihales will update you on our ongoing activities. I will then comment on our financial results before opening the lines for your questions.

謝謝你，艾瑪。下午好，感謝您加入我們討論 Vanda Pharmaceuticals 2022 年第三季度的業績。我們的 2022 年第三季度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。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 Mihales Polymeropoulos 博士。此外，我們還有總法律顧問蒂姆·威廉姆斯 (Tim Williams)； Gunther Birznieks，我們的業務發展高級副總裁兼研發委員會成員。在我的介紹性發言之後，Mihales 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 annual report on Form 10-K for the fiscal year ended December 31st, 2021, 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. 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.

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。這些風險在我們截至 2021 年 12 月 31 日止財政年度的 10-K 表年度報告中關於前瞻性陳述、風險因素以及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進行了描述，如下所示：根據我們隨後的 10-Q 表格季度報告、8-K 表格當前報告以及向 SEC 提交的其他文件進行更新，這些文件可在 SEC 的 EDGAR 系統和我們的網站上找到。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. Mihales Polymeropoulos.

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

Thank you, Kevin, and good afternoon, everyone. Thank you for joining us to discuss Vanda's third-quarter 2022 results. Over the last quarter, Vanda continued to focus on enhancing performance of its current commercial products, advancing clinical programs, and leveraging innovation to position the company for long-term growth. I will discuss some highlights of our clinical and regulatory efforts, and Kevin will discuss our commercial progress. First on Fanapt. Our clinical program pipeline is advancing with the recent completion of enrollment in the Fanapt bipolar mania clinical study, for which we expect results by the end of this quarter. Additionally, we have completed enrollment in our VQW765 study in performance anxiety for which also we expect results by end of this quarter.

謝謝你，凱文，大家下午好。感謝您加入我們討論 Vanda 2022 年第三季度的業績。在上個季度，中聯繼續專注於提高其當前商業產品的性能，推進臨床項目，並利用創新為公司的長期增長定位。我將討論我們臨床和監管工作的一些亮點，凱文將討論我們的商業進展。首先在 Fanapt 上。我們的臨床項目管道正在推進，最近完成了 Fanapt 雙相躁狂症臨床研究的註冊，我們預計該研究的結果將在本季度末公佈。此外，我們已經完成了關於表現焦慮的 VQW765 研究的註冊，我們也預計在本季度末會有結果。

On Tradipitant, preparation of the new drug application in gastroparesis is ongoing with FDA submission expected in the first half of 2023. The submission will include the results from 2 adequate and well-controlled studies in patients with idiopathic and diabetic gastroparesis, which provides substantial evidence of effectiveness in the indication. If approved, Tradipitant will be the first treatment in more than 40 years approved by the FDA for people with gastroparesis. Additionally, a 400-patient open-label study of Tradipitant in patients with gastroparesis is ongoing, which will provide further information on the safety and efficacy of Tradipitant in gastroparesis. We recently presented results of the pooled analysis from Studies VLY-686-3301 and VLY-686-2301, which included a total of 342 patients, 175 on Tradipitant, 167 on placebo, which showed significant improvement in the clinical endpoints of change of nausea, percent [nausea] days, and the gastroparesis core symptom improvement scale, GCSI, at week 4 treatment. In the subpopulation, which excludes non-protocol compliant patients as determined by PK analysis, a total number of 283 patients, highly significant effects were seen in each of these parameters. Improvements were also seen across the other core symptoms of gastroparesis as well. This work was recently presented at the American College of Gastroenterology Conference and received the Presidential Poster Award.

關於 Trapitant，胃輕癱新藥申請的準備工作正在進行中，預計將於 2023 年上半年提交 FDA。該提交將包括 2 項針對特發性和糖尿病性胃輕癱患者的充分且對照良好的研究結果，這些研究提供了大量證據適應症的有效性。如果獲得批准，Trapitant 將成為 40 多年來 FDA 批准用於治療胃輕癱患者的第一種藥物。此外，一項針對 400 名胃輕癱患者的 Trapitant 開放標籤研究正在進行中，這將提供有關 Tradipitant 治療胃輕癱的安全性和有效性的更多信息。我們最近展示了研究 VLY-686-3301 和 VLY-686-2301 的匯總分析結果，其中包括總共 342 名患者，其中 175 名服用 Trapitant，167 名服用安慰劑，這表明噁心變化的臨床終點有顯著改善、[噁心]天數百分比和胃輕癱核心症狀改善量表 GCSI，在第 4 週的治療中。在排除了通過 PK 分析確定的不符合方案的患者的亞群中，共有 283 名患者，在這些參數中的每一個中都看到了非常顯著的影響。胃輕癱的其他核心症狀也有所改善。這項工作最近在美國胃腸病學會會議上發表，並獲得了總統海報獎。

Tradipitant efficacy is also appreciated by patients who are participating in an expanded access program, some already for over a year. Tradipitant motion sickness. On Tradipitant, we're also progressing with the clinical program in motion sickness with a pivotal study currently ongoing and expected to be completed in the first half of 2023. HETLIOZ, enrollment is ongoing in the clinical development programs of HETLIOZ for the treatment of delayed sleep phase disorder and for sleep turbances in autism spectrum disorder. Additionally, we are preparing for the submission of a supplemental NDA for HETLIOZ in the treatment of insomnia. The submission will include the results of 3 adequate and well-controlled studies, 1 4-week study in people with primary insomnia, and 2 trends insomnia new studies induced by phase advance of the sleep [way] cycle.

Trapitant 的療效也受到參與擴大獲取計劃的患者的讚賞，有些患者已經參與了一年多。 Trapitant 暈車。在 Tradipitant 上，我們還在推進暈動病的臨床項目，目前正在進行一項關鍵研究，預計將於 2023 年上半年完成。睡眠階段障礙和自閉症譜系障礙的睡眠紊亂。此外，我們正在準備提交 HETLIOZ 治療失眠的補充 NDA。提交的內容將包括 3 項充分且控制良好的研究的結果，1 項針對原發性失眠症患者的 4 週研究，以及 2 項由睡眠[方式]週期的相位提前引起的失眠趨勢新研究。

These studies show that HETLIOZ is effective in improving sleep onset difficulty in people with primary insomnia with the effect observed as [HETLIOZ] is the first line of treatment. This supplemental NDA of HETLIOZ for insomnia is planned to be submitted to the FDA this quarter. VPO-227 in cholera. We recently announced that the FDA has granted orphan drug designation for VPO-227 for the treatment of cholera. Cholera remains a major public health challenge and recognized unmet medical need despite decades-long public health efforts, and we're excited about the potential of VPO-227 to treat patients that suffer from cholera. We expect to submit an investigational new drug application to the FDA for VPO-227 in 2023.

這些研究表明，HETLIOZ 可有效改善原發性失眠患者的入睡困難，觀察到的效果是 [HETLIOZ] 是一線治療。 HETLIOZ 針對失眠症的補充 NDA 計劃於本季度提交給 FDA。霍亂中的 VPO-227。我們最近宣布，FDA 已授予 VPO-227 治療霍亂的孤兒藥稱號。儘管進行了長達數十年的公共衛生努力，霍亂仍然是一項重大的公共衛生挑戰和未滿足的醫療需求，我們對 VPO-227 治療霍亂患者的潛力感到興奮。我們預計在 2023 年向 FDA 提交 VPO-227 的新藥研究申請。

Finally, we recently announced the research and development agreement with OliPass of Korea to jointly develop a set of antisense oligonucleotide, or ASO based on OliPass proprietary modified peptide nucleic acids. This evolving discovery and development platform is intended to support Vanda's development of antisense oligonucleotide or ASO based on precision medicine therapeutics.

最後，我們最近宣布與韓國 OliPass 達成研發協議，共同開發一套反義寡核苷酸，即基於 OliPass 專有修飾肽核酸的 ASO。這個不斷發展的發現和開發平台旨在支持 Vanda 基於精準醫學治療的反義寡核苷酸或 ASO 的開發。

Tim Williams, our General Counsel, will now discuss highlights of our legal regulatory activities. Tim?

我們的總法律顧問蒂姆·威廉姆斯 (Tim Williams) 現在將討論我們法律監管活動的要點。蒂姆？

Thank you, Mihales. I'd like to touch briefly on some key litigation activities, first in intellectual property. As you probably know, we had a trial last March in Delaware Federal Court of serving a family of HETLIOZ patents against several generic drug manufacturers. Patents in this litigation have excise ranging from 2033 to 25 – 2035. So a positive victory on any single patent extends HETLIOZ exclusivity at least into 2033 and possibly all the way into 2035. We expect a decision from the court in the later than the end of this year. I'll turn for a moment to our ongoing regulatory litigation. We continue to challenge regulators when we believe those regulators have ignored or violated law in a manner that harms our business or impacts our ability to help patients.

謝謝你，米哈萊斯。我想簡要談談一些關鍵的訴訟活動，首先是知識產權方面的活動。您可能知道，我們去年 3 月在特拉華州聯邦法院進行了一項針對幾家仿製藥製造商的 HETLIOZ 專利系列的審判。此訴訟中的專利的消費稅期限為 2033 年至 25 年至 2035 年。因此，任何一項專利的積極勝利都會將 HETLIOZ 的獨占性至少延長至 2033 年，並可能一直延長至 2035 年。我們預計法院將在晚於今年年底。我將暫時談談我們正在進行的監管訴訟。當我們認為監管機構以損害我們業務或影響我們幫助患者的能力的方式忽視或違反法律時，我們將繼續挑戰監管機構。

A prime example of this is our lawsuit against CMS filed in April of this year. At the end of 2021, CMS issued a new rule that expanded the scope of products subject to certain rebate requirements. And it did so by reversing an agency interpretation that has been in place for over 10 years. Rather than getting greater authority from Congress to expand its rebate powers, CMS simply changed its long-standing interpretation of the law and issued the new rule. This new rule now subjects novel product formulations to expensive rebate requirements and has an immediate financial consequence for innovators like Vanda. It also negatively impacts the viability of future product development across the industry to the detriment of patients suffering with unmet medical needs. We are not the only company to challenge CMS on this rule in court, but we hope to be the first to prevail and striking it down. This is just one example of our efforts to advance Vanda's business by holding regulators accountable to the law and our other efforts are more fully described in our public disclosures and publicly available court papers.

一個典型的例子是我們在今年 4 月對 CMS 提起的訴訟。 2021年底，康哲藥業出台新規，擴大了部分返利要求的產品範圍。它通過推翻已經實施了 10 多年的機構解釋來做到這一點。 CMS 沒有從國會獲得更大的權力來擴大其退稅權力，而是簡單地改變了其長期以來對法律的解釋並發布了新規則。這條新規則現在使新產品配方受到昂貴的回扣要求，並對像 Vanda 這樣的創新者產生直接的財務影響。它還對整個行業未來產品開發的可行性產生負面影響，從而損害醫療需求未得到滿足的患者。我們不是唯一一家在法庭上就此規則挑戰 CMS 的公司，但我們希望成為第一個獲勝並打擊它的公司。這只是我們通過讓監管機構對法律負責來推進 Vanda 業務的一個例子，我們的其他努力在我們的公開披露和公開的法庭文件中有更全面的描述。

With that, I'll turn it back to Mihales.

有了這個，我會把它轉回給 Mihales。

Thank you very much, Tim. I'll turn now to Kevin to discuss our commercial progress and financial results.

非常感謝你，蒂姆。我現在請凱文討論我們的商業進展和財務結果。

Thank you, Mihales. I will begin by summarizing our financial results for the first 9 months of 2022 before turning to discuss the third quarter of 2022. Total revenues for the first 9 months of 2022 were $189.9 million, a 5% decrease compared to $200.7 million for the same period in 2021. HETLIOZ net product sales of $119.6 million were the primary contributor and driver of our revenues for the first 9 months of 2022 and saw an 8% decrease compared to the same period in 2021. The first 9 months of 2022 reflect the continued reimbursement challenges for prescriptions for patients with Non-24.

謝謝你，米哈萊斯。我將首先總結我們 2022 年前 9 個月的財務業績，然後再討論 2022 年前 9 個月的總收入。2022 年前 9 個月的總收入為 1.899 億美元，與同期的 2.007 億美元相比下降 5% 2021 年。HETLIOZ 產品淨銷售額為 1.196 億美元，是我們 2022 年前 9 個月收入的主要貢獻者和推動力，與 2021 年同期相比下降了 8%。2022 年前 9 個月反映了持續報銷非 24 歲患者的處方挑戰。

Turning now to Fanapt. Fanapt net product sales of $70.3 million for the first 9 months of 2022 reflect a 1% decrease compared to the same period in 2021. For the first 9 months of 2022, Vanda recorded a net loss of $600,000 compared to net income of $26.1 million for the same period in 2021. The net loss for the first 9 months of 2022 include an income tax provision of $2.3 million as compared to an income tax provision of $7.7 million for the same period in 2021. Operating expenses for the first 9 months of 2022 were $190.2 million compared to $167.1 million for the first 9 months of 2021. The $23.1 million increase was primarily driven by both higher R&D expenses and higher SG&A expenses. The increase in R&D expenses was primarily driven by increases related to our late-stage clinical program for Fanapt as well as a $3 million upfront fee expense in the third quarter of 2022 in consideration for entering into the previously announced OliPass agreement. The increase in SG&A expenses was driven primarily by higher costs associated with legal support related to ongoing litigation, sales activities, commercial support, and other corporate activities. Vanda's cash, cash equivalents, and marketable securities referred to as cash as of September 30th, 2022, was $454.8 million, representing an increase of $48.8 million in cash or 12% as compared to September 30th, 2021, and an increase of $22 million or 5% as compared to December 31st, 2021.

現在轉向 Fanapt。 Fanapt 2022 年前 9 個月的產品淨銷售額為 7030 萬美元，與 2021 年同期相比下降了 1%。2022 年前 9 個月，Vanda 錄得淨虧損 60 萬美元，而淨收入為 2610 萬美元2021 年同期。2022 年前 9 個月的淨虧損包括 230 萬美元的所得稅撥備，而 2021 年同期的所得稅撥備為 770 萬美元。2022 年前 9 個月的運營費用2021 年前 9 個月的收入為 1.902 億美元，而 2021 年前 9 個月為 1.671 億美元。增加 2310 萬美元的主要原因是研發費用和 SG&A 費用增加。研發費用的增加主要是由於與我們的 Fanapt 後期臨床計劃相關的增加以及 2022 年第三季度 300 萬美元的預付費用，以考慮簽訂先前宣布的 OliPass 協議。 SG&A 費用的增加主要是由於與正在進行的訴訟、銷售活動、商業支持和其他公司活動相關的法律支持相關的成本增加。截至 2022 年 9 月 30 日，Vanda 的現金、現金等價物和有價證券（稱為現金）為 4.548 億美元，比 2021 年 9 月 30 日增加了 4880 萬美元現金或 12%，比 2021 年 9 月 30 日增加了 2200 萬美元或與 2021 年 12 月 31 日相比增加了 5%。

Turning now to our quarterly results. Total revenues for the third quarter of 2022 were $65.3 million, a 7% decrease compared to $70.1 million for the third quarter of 2021. HETLIOZ net product sales were $41.3 million for the third quarter of 2022, a 9% decrease compared to $45.6 million for the third quarter of 2021. Consistent with the first 9 months of 2022, net sales for the period reflect the continued reimbursement challenges for prescriptions for patients with Non-24.

現在轉向我們的季度業績。 2022 年第三季度的總收入為 6530 萬美元，與 2021 年第三季度的 7010 萬美元相比下降了 7%。HETLIOZ 2022 年第三季度的產品淨銷售額為 4130 萬美元，與 2021 年第三季度的 4560 萬美元相比下降了 9%。 2021 年第三季度。與 2022 年前 9 個月一致，該期間的淨銷售額反映了非 24 歲患者處方藥的持續報銷挑戰。

Turning to Fanapt. Fanapt net product sales for the third quarter of 2022 were $24 million, a 2% decrease compared to $24.5 million for the third quarter of 2021. Fanat prescriptions for the third quarter of 2022, as reported by [Equibia Exponent] decreased by approximately 2% compared to the second quarter of 2022. For the third quarter of 2022, Vanda recorded net income of $3.3 million compared to net income of $7.8 million for the third quarter of 2021. The Net income for the third quarter of 2022 included an income tax provision of $2.2 million as compared to an income tax provision of $3 million for the same period in 2021. Operating expenses for the third quarter of 2022 were $61.4 million compared to $59.3 million for the third quarter of 2021. The $2.1 million increase was driven primarily by higher R&D expenses, partially offset by a decrease in SG&A expenses. The increase in R&D expenses was driven primarily by costs associated with our late-stage clinical programs for Fanapt and Tradipitant and a $3 million upfront fee expense in the third quarter of 2022 in consideration of the previously [done] OliPass agreement.

轉向 Fanapt。 Fanapt 2022 年第三季度的產品淨銷售額為 2400 萬美元，與 2021 年第三季度的 2450 萬美元相比下降了 2%。[Equibia Exponent] 報告的 2022 年第三季度 Fanat 處方藥減少了約 2%與 2022 年第二季度相比。2022 年第三季度，Vanda 的淨收入為 330 萬美元，而 2021 年第三季度的淨收入為 780 萬美元。2022 年第三季度的淨收入包括所得稅準備金220 萬美元，而 2021 年同期的所得稅撥備為 300 萬美元。2022 年第三季度的運營費用為 6140 萬美元，而 2021 年第三季度為 5930 萬美元。210 萬美元的增長主要是由於更高的研發費用，部分被 SG&A 費用的減少所抵消。研發費用的增加主要是由於與我們的 Fanapt 和 Tradipitant 後期臨床項目相關的成本，以及考慮到之前[完成的] OliPass 協議，2022 年第三季度的 300 萬美元預付費用。

The decrease in SG&A expenses was driven primarily by a decrease in DTC awareness spending, partially offset by an increase in sales force expenditures. Operating expenses for the third quarter of 2022 were essentially flat as compared to $60.9 million for the second quarter of 2022. And again, the third quarter operating expenses included the $3 million upfront fee associated with the OliPass agreement. Vanda's cash balance as of September 30, 2022, again, was $454.8 million, representing an increase of $13.9 million or 3% as compared to June 30th, 2022. Vanda is providing an update to its prior 2022 guidance. Vanda expects to achieve the following financial objectives in 2022. Net product sales from both HETLIOZ and Fanapt of between $240 million and $270 million. This compares to prior guidance of between $240 million and $280 million; HETLIOZ net product sales of between $150 million and $170 million. This compares to prior guidance of between $150 million and $180 million; Fanapt net product sales of between $90 million and $100 million and year-end 2022 cash of greater than $450 million. This compares to prior guidance of greater than $440 million.

SG&A 費用的減少主要是由於 DTC 意識支出的減少，部分被銷售人員支出的增加所抵消。與 2022 年第二季度的 6090 萬美元相比，2022 年第三季度的運營費用基本持平。第三季度的運營費用再次包括與 OliPass 協議相關的 300 萬美元預付費用。截至 2022 年 9 月 30 日，Vanda 的現金餘額再次為 4.548 億美元，與 2022 年 6 月 30 日相比增加了 1390 萬美元或 3%。Vanda 正在更新其之前的 2022 年指引。 Vanda 預計在 2022 年實現以下財務目標。HETLIOZ 和 Fanapt 的產品淨銷售額在 2.4 億美元至 2.7 億美元之間。相比之下，之前的指導價值在 2.4 億美元至 2.8 億美元之間； HETLIOZ 產品淨銷售額在 1.5 億美元至 1.7 億美元之間。相比之下，之前的指導值在 1.5 億至 1.8 億美元之間； Fanapt 的產品淨銷售額在 9000 萬至 1 億美元之間，2022 年年底的現金超過 4.5 億美元。相比之下，之前的指導價值超過 4.4 億美元。

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

有了這個，我現在將電話轉回給 Mihales。

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

非常感謝，凱文和蒂姆。在這一點上，我們很樂意回答我們的任何問題。

(Operator Instructions). Your first question today comes from the line of Chris Howerton with Jefferies.

（操作員說明）。您今天的第一個問題來自 Jefferies 的 Chris Howerton。

This is [Ajay] here for Chris. Can you go over what led to your decision to file on SNDA for HETLIOZ for insomnia now? Have you discussed your application with the FDA? And will you be using the 2008 study? Or is there some new data that you're submitting?

我是 [Ajay] 來找 Chris。你能回顧一下是什麼導致你現在決定為 HETLIOZ 申請 SNDA 治療失眠嗎？您是否與 FDA 討論過您的申請？您會使用 2008 年的研究嗎？或者您是否提交了一些新數據？

First of all, just to clarify, we have not filed yet SNDA or do we plan to file this quarter. And yes, the chronic insomnia for week study is the 2008 study. And the 2 additional studies in -- that will support this application are change -- insomnia studies or phase advance that we have reported in the past.

首先，澄清一下，我們還沒有提交 SNDA，或者我們是否計劃在本季度提交。是的，每週研究的慢性失眠是 2008 年的研究。另外兩項支持該應用的研究是改變我們過去報告的失眠研究或階段進展。

There are no further questions at this time. I would now like to turn the call back over to Vanda management for closing remarks.

目前沒有其他問題。我現在想把電話轉回給 Vanda 管理層作結束語。

Thank you very much for joining us for this call, and we'll talk to you in the future. Thank you.

非常感謝您加入我們的電話會議，我們將在未來與您交談。謝謝你。