Zealand Pharma A/S (ZEAL) 2022 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Zealand Pharma Second Quarter 2022 Financial Results Conference Call and Webcast. (Operator Instructions). Please note that today's conference is being recorded.

美好的一天，感謝您的支持。歡迎參加西蘭製藥 2022 年第二季財務業績電話會議和網路廣播。 （操作員說明）。請注意，今天的會議正在錄製中。

I would now like to hand over to your speaker, Anna Krassowska. Please go ahead.

現在我想把發言權交給您的發言人安娜·克拉索斯卡 (Anna Krassowska)。請繼續。

Thank you, operator. Welcome, and thank you for joining us today to discuss Zealand's second quarter results for 2022. I'm Anna Krassowska, Vice President of Investor Relations and Corporate Communications at Zealand. With me today are the following members of Zealand's management team. Adam Steensberg, President and Chief Executive Officer; Matt Dallas, Senior Vice President and Chief Financial Officer; and David Kendall, Chief Medical Officer. You can find the related company announcement and supporting information on our website at zealandpharma.com.

謝謝你，接線生。歡迎並感謝您今天加入我們討論 Zealand 2022 年第二季業績。我是 Anna Krassowska，Zealand 投資者關係和企業傳播副總裁。今天與我在一起的有 Zealand 管理團隊的以下成員。亞當‧斯滕斯伯格，總裁兼執行長；馬特‧達拉斯，資深副總裁兼財務長；和首席醫療官大衛·肯德爾。您可以在我們的網站 zealandpharma.com 上找到相關公司公告和支援資訊。

I would like to point out that we will be making forward-looking statements that are subject to risks and uncertainties. These statements are valid only as of today, and the company assumes no obligation to update them, except as required by law. Please refer to recent filings for a more complete picture of risks and other factors.

我想指出的是，我們將做出前瞻性陳述，這些陳述存在風險和不確定性。這些聲明僅截至今日有效，本公司不承擔更新這些聲明的義務，除非法律要求。請參閱最近提交的文件，以更全面地了解風險和其他因素。

With that, I will turn the call over to President and CEO, Adam Steensberg. Adam?

接下來，我將把電話轉給總裁兼執行長 Adam Steensberg。亞當？

Thank you, Anna, and thanks to everyone for joining today. Please turn to Slide 3.

謝謝你，安娜，也謝謝大家今天的加入。請翻到幻燈片 3。

This has been a busy quarter for the company, and I'm really happy with the progress we have made on multiple fronts following the announcement of our strategy to prioritize investments into R&D.

對於公司來說，這是一個忙碌的季度，在宣布優先投資研發的策略後，我對我們在多個方面的進展感到非常高興。

In light of these changes, I'm pleased that we completed the sales of V-Go to MannKind in May. For the Zegalogue rescue pen, we are in advanced partner discussions, and I hope to provide an update on this front soon.

鑑於這些變化，我很高興我們在 5 月完成了向 MannKind 的 V-Go 銷售。對於 Zegalogue 救援筆，我們正在進行高級合作夥伴討論，我希望盡快提供這方面的最新資訊。

In the second quarter, we strengthened our balance sheet. First, by amending the existing note purchase agreement with Oberland Capital, and secondly, by executing a private placement with certain institutional investors. This has extended our cash runway beyond important clinical milestones.

第二季度，我們加強了資產負債表。首先，修改與 Oberland Capital 現有的票據購買協議；其次，與某些機構投資者進行私募。這使我們的現金跑道超出了重要的臨床里程碑。

As part of the restructuring activities, we continue to focus on improving our operational effectiveness and implementing corporate cost reductions. Earlier this week, we announced the decision to end the non-liquid ADS program which has been in place since August '17. Today, the American Depositary Shares accounts for less than 1.5% of the total share capital. And by consolidating our listing to NASDAQ Copenhagen, we believe we can maintain trading flexibility for global investors while achieving certain operating efficiencies for the company and reducing costs.

作為重組活動的一部分，我們繼續專注於提高營運效率和實施企業成本削減。本週早些時候，我們宣布決定終止自 2017 年 8 月以來實施的非流動性 ADS 計畫。如今，美國存託股票佔總股本的比例不到1.5%。透過合併在納斯達克哥本哈根上市，我們相信我們可以為全球投資者保持交易靈活性，同時為公司實現一定的營運效率並降低成本。

Following those corporate updates, I would like to touch on the clinical pipeline to briefly review some of the progress and upcoming milestones before I turn the call over to David Kendall for additional details and color.

在這些公司更新之後，我想談談臨床管道，簡要回顧一些進展和即將到來的里程碑，然後再將電話轉給 David Kendall 以獲取更多細節和顏色。

Key priorities are shown on Slide 4. As we give you the pipeline, I want to draw your attention to the revised timelines related to dasiglucagon for Bihormonal Artificial Pancreas system. This is a consequence of focusing our resources as we execute our new strategy and not a reflection of our [attention] for the program.

關鍵優先事項如幻燈片 4 所示。當我們向您提供管道時，我想提請您注意與雙激素人工胰腺系統的 dasiglucagon 相關的修訂時間表。這是我們在執行新策略時集中資源的結果，而不是我們對該計劃的[關注]的反映。

In May, we announced positive results from the Phase III trial of dasiglucagon in infants with congenital hyperinsulinism, or CHI. We are preparing a new drug application or NDA for dasiglucagon, and following our pre-NDA meeting with the FDA, we now anticipate submission in the first quarter of '23.

五月份，我們宣布了 dasiglucagon 在先天性高胰島素血症 (CHI) 嬰兒中進行的 III 期試驗取得了積極結果。我們正在準備 dasiglucagon 的新藥申請或 NDA，在與 FDA 舉行 NDA 前會議後，我們現在預計在 23 年第一季提交。

At the scientific sessions of the American Diabetes Association in June, we presented Phase I data for dapiglutide, our long-acting GLP-1/GLP-2 dual agonist, showing encouraging weight loss in healthy volunteers. This data has given us the confidence to move this molecule forward in obesity, as also announced in June.

在 6 月的美國糖尿病協會科學會議上，我們展示了達匹魯肽（我們的長效 GLP-1/GLP-2 雙激動劑）的 I 期數據，顯示健康志願者的體重減輕令人鼓舞。正如 6 月宣布的那樣，這些數據使我們有信心推動這種分子在肥胖方面取得進展。

In July, we achieved last patient, last visit in EASE SBS 1, our Phase III trial with glepaglutide in short bowel syndrome, and now look forward to seeing the results late in the quarter.

7 月，我們在 EASE SBS 1（我們的格列魯肽治療短腸症候群的 III 期試驗）中完成了最後一位患者、最後一次就診，現在期待在本季度末看到結果。

At the upcoming European Association for the Study of Diabetes Annual Meeting in September, our partner, Boehringer Ingelheim, will present Phase II data for glucagon GLP-1 receptor dual agonist in patients with Type 2 diabetes. And finally, we anticipate initial Phase I clinical data from our amylin analog later in the year.

在即將於 9 月舉行的歐洲糖尿病研究協會年會上，我們的合作夥伴勃林格殷格翰將展示胰高血糖素 GLP-1 受體雙重激動劑治療 2 型糖尿病患者的 II 期數據。最後，我們預計今年稍後我們的胰淀素類似物將獲得初步的 I 期臨床數據。

And with that, I will now turn over the call to David Kendall. David was appointed Zealand's Chief Medical Officer in June, and for the past 2 years, he has been serving as a senior global medical adviser to the company. And before joining us, he has held senior leadership positions in clinical and academic medicine and in the biopharmaceutical industry. We're extremely excited to harness his broad experience in diabetes and metabolic diseases that spans more than 35 years. David?

現在，我將把電話轉給大衛肯德爾。 David於6月被任命為Zealand的首席醫療官，在過去的兩年裡，他一直擔任該公司的高級全球醫療顧問。在加入我們之前，他曾在臨床和學術醫學以及生物製藥行業擔任高級領導職務。我們非常高興能夠利用他在糖尿病和代謝疾病方面超過 35 年的豐富經驗。大衛？

Thank you for the kind introduction, Adam.

謝謝你的熱情介紹，亞當。

I would like to begin by discussing the progress with our dasiglucagon program in patients with congenital hyperinsulinism, or CHI, an ultra-rare pediatric disease in which patients suffer from recurrent and persistent hypoglycemia due to excessive insulin production.

首先，我想討論一下我們的dasiglucagon 計畫在先天性高胰島素血症（CHI）患者中的進展，CHI 是一種極其罕見的兒科疾病，患者因胰島素分泌過多而遭受反复且持續的低血糖症。

On Slide 5, we have summarized key data. As you may recall, we previously reported data showing a clinically meaningful reduction in rates of hypoglycemia measured by continuous glucose monitoring in the Phase III trial in older children when treated with dasiglucagon added to standard of care, shown in the left-hand panel.

在投影片 5 中，我們總結了關鍵數據。您可能還記得，我們​​先前報告的數據顯示，在大齡兒童的III 期試驗中，當在標準護理中添加達西高血糖素治療時，透過連續血糖監測測量到的低血糖發生率出現了具有臨床意義的降低，如左圖所示。

In May, we announced positive top line results from the Phase III trial in 12 infants up to 12 months of age with CHI who required continuous intravenous glucose support to prevent or manage hypoglycemia. The focus of this trial was to evaluate the ability of dasiglucagon treatment to reduce and eventually remove the need for continuous IV glucose infusion. The trial met its primary endpoint, demonstrating that dasiglucagon, delivered as a continuous subcutaneous infusion via pump, resulted in a statistically significant and clinically meaningful reduction in the requirement for IV glucose when compared to placebo.

5 月份，我們宣布了對 12 名 12 個月大的 CHI 嬰兒進行的 III 期試驗的積極頂線結果，這些嬰兒需要持續靜脈注射葡萄糖支持來預防或控制低血糖。該試驗的重點是評估達西高血糖素治療減少並最終消除連續靜脈注射葡萄糖的需要的能力。該試驗達到了主要終點，顯示與安慰劑相比，透過幫浦連續皮下輸注的達西高血糖素導致靜脈注射葡萄糖的需求量顯著降低，具有統計學意義和臨床意義。

Numerically, dasiglucagon treatment reduced the mean glucose infusion rate to 4.3 milligrams per kilogram per minute compared with 9.5 milligrams per kilogram per minute with placebo, a treatment difference of 5.2 milligrams per kilogram per minute, which is a 55% reduction in the requirement for glucose by IV infusion. It is also worth noting that 11 out of the 12 patients participating in the trial subsequently enrolled into the ongoing long-term safety extension study.

從數字上看，達西高血糖素治療將平均葡萄糖輸注速率降低至每公斤每分鐘4.3 毫克，而安慰劑組為每公斤每分鐘9.5 毫克，治療差異為每公斤每分鐘5.2 毫克，即葡萄糖需求量減少了55%經由靜脈輸注。還值得注意的是，參與試驗的 12 名患者中有 11 名隨後參加了正在進行的長期安全性擴展研究。

We look forward to presenting the full trial results of Study 103 at the European Society for Pediatric Endocrinology or ESPE Annual Meeting in mid-September.

我們期待在 9 月中旬的歐洲兒科內分泌學會或 ESPE 年會上展示研究 103 的完整試驗結果。

We anticipate the data from this Phase III trial, along with data from the previous Phase III trial in older children as well as the information derived from the safety extension trial, will form the basis of an NDA for dasiglucagon in CHI, and we expect to submit in the first quarter of 2023. We had previously projected the submission in late 2022. However, as the NDA preparation is now underway, the revised timeline reflects the comprehensive analysis for individual patient outcomes that we believe are essential for our submission, which we further believe will ensure as complete a data set as possible for our NDA targeting this ultra-rare disease.

我們預計，本次III 期試驗的數據、先前針對年齡較大兒童的III 期試驗的數據以及從安全性擴展試驗中獲得的信息，將構成dasiglucagon 在CHI 中的新藥申請(NDA) 的基礎，我們預計於2023 年第一季提交。我們之前預計於2022 年末提交。然而，由於NDA 準備工作正在進行中，修訂後的時間表反映了對個別患者結果的綜合分析，我們認為這對我們的提交至關重要，我們進一步相信將確保我們針對這種極為罕見疾病的 NDA 擁有盡可能完整的資料集。

Turning to Slide 6. Our full pipeline is shown here, and I will highlight a few of our programs.

轉向投影片 6。這裡顯示了我們的完整流程，我將重點介紹我們的一些項目。

First, I would like to share an update on another of our dasiglucagon projects, namely, the bihormonal artificial pancreas program, which as many of you know, is being performed in collaboration with Beta Bionics. We have recently aligned with our partners on a sequential approach for the Phase III pivotal program. The Phase III program now consists of 3 sub trials designed to support the marketing application for the Bihormonal iLet Bionic Pancreas, known as the iLet Duo, and an NDA for the use of dasiglucagon in bihormonal artificial pancreas systems for the treatment of Type 1 diabetes.

首先，我想分享我們的另一個 dasiglucagon 項目的最新情況，即雙激素人工胰腺項目，正如你們許多人所知，該項目正在與 Beta Bionics 合作進行。我們最近與我們的合作夥伴就第三階段關鍵計劃的順序方法達成了一致。 III 期計畫目前包括 3 個子試驗，旨在支持雙激素 iLet 仿生胰腺（稱為 iLet Duo）的營銷應用，以及在雙激素人工胰腺系統中使用 dasiglucagon 治療 1 型糖尿病的新藥申請 (NDA)。

Our 2 companies have agreed that the smaller crossover study of 60 patients to assess safety and efficacy of the Bihormonal iLet Duo and insulin-only configuration, known as the iLet, will now be completed prior to initiating the 2 larger randomized controlled Phase III trials, which will include 350 adults and 350 pediatric participants. Importantly, the sequential approach allows for an initial assessment of clinical outcomes from the shorter-term comparative trial prior to initiation of the main pivotal trials. The clinical protocols are being updated accordingly, and we expect Beta Bionics to initiate the small crossover trial in early 2023. We believe this sequential approach will allow us to optimize Phase III execution and use our resources most effectively.

我們的兩家公司已同意，在啟動2 項規模更大的隨機對照III 期試驗之前，現在將完成一項由60 名患者參與的小型交叉研究，以評估雙激素iLet Duo 和純胰島素配置（稱為iLet）的安全性和有效性。其中將包括 350 名成人和 350 名兒童參與者。重要的是，序貫方法允許在主要關鍵試驗開始之前對短期比較試驗的臨床結果進行初步評估。臨床方案正在相應更新，我們預計 Beta Bionics 將於 2023 年初啟動小型交叉試驗。我們相信這種順序方法將使我們能夠優化 III 期執行並最有效地利用我們的資源。

Moving on to glepaglutide, our long-acting GLP-2 analog being investigated for the potential treatment of short bowel syndrome. The pivotal Phase III EASE-1 study is designed to allow us to demonstrate a significant reduction in the need for parenteral support for people living with SBS. A once or twice weekly fixed dose injection of glepaglutide, delivered by a ready-to-use auto injector, can provide clear and very important features of differentiation from the currently-approved product.

接下來是格列魯肽，我們的長效 GLP-2 類似物正在研究用於短腸症候群的潛在治療。關鍵的 III 期 EASE-1 研究旨在讓我們證明 SBS 患者對腸外支持的需求顯著減少。透過即用型自動注射器每週注射一次或兩次固定劑量的格列魯肽，可以提供與目前批准的產品明顯且非常重要的區別特徵。

We are excited to report that we have recently achieved last patient, last visit in the Phase III EASE-1 trial, and our expectation is to have top line results available by the end of September or early October of this year. Pending review of these data, we anticipate that this randomized controlled trial will serve as the basis for our planned NDA for glepaglutide.

我們很高興地報告，我們最近完成了 III 期 EASE-1 試驗的最後一位患者、最後一次就診，我們期望在今年 9 月底或 10 月初獲得最重要的結果。在對這些數據進行審查之前，我們預計這項隨機對照試驗將作為我們計劃的格魯肽 NDA 的基礎。

Moving to a discussion of our work in obesity, we believe we have a number of novel and exciting assets in our current portfolio, and we are pleased to be advancing this clinical portfolio, including our GLP-1/GLP-2 dual agonist, our novel long-acting amylin analog, and the dual glucagon GLP-1 receptor agonist, all assets generated from our peptide platform.

接下來討論我們在肥胖方面的工作，我們相信我們目前的產品組合中有許多新穎且令人興奮的資產，我們很高興能夠推進這一臨床產品組合，包括我們的GLP-1/GLP-2 雙激動劑、我們的新型長效胰淀素類似物和雙胰高血糖素 GLP-1 受體激動劑，所有資產均來自我們的勝肽平台。

Initial data from the clinical studies of our GLP-1/GLP-2 dual agonist, dapiglutide, reported at this year's American Diabetes Association Scientific Sessions, demonstrated a weight loss of up to 4.3% from baseline after only 4 weeks of treatment in a Phase I trial of healthy volunteers. Our novel long-acting amylin analog is currently under study in Phase I clinical trials, and we expect data from the Phase I single ascending dose trial by the end of 2022.

今年的美國糖尿病協會科學會議上報告的 GLP-1/GLP-2 雙激動劑達匹魯肽臨床研究的初步數據表明，在一個階段僅治療 4 週後，體重較基線減輕高達 4.3%我對健康志願者進行了試驗。我們的新型長效胰淀素類似物目前正在 I 期臨床試驗中進行研究，我們預計在 2022 年底前獲得 I 期單劑量遞增試驗的數據。

This amylin asset is differentiated by virtue of design characteristics that both allows for once-weekly dosing and for formulation and co-formulation with other peptides in the physiologic pH range, a feature that should facilitate the potential for development of combination therapies.

這種胰淀素資產的獨特之處在於其設計特徵，既允許每週一次給藥，又允許在生理pH 範圍內與其他勝肽進行配製和聯合配製，這一特徵應有助於開發聯合療法的潛力。

Additionally, initial data readouts from the Phase II program for the long-acting dual glucagon receptor GLP-1 receptor agonist, also known as BI 456906, being developed with Boehringer Ingelheim, will be disclosed later this year. Initial data from the Phase II trial in Type 2 diabetes is scheduled for presentation at the European Association for the Study of Diabetes in September highlighting the primary endpoint of the trial, the dose relationship of treatment on hemoglobin A1c from baseline to 16 weeks relative to placebo. Along with our BI colleagues, we also anticipate presentation of the secondary endpoints of the Type 2 diabetes trial, assessing the effect of change on body weight at a scientific congress later in 2022.

此外，與勃林格殷格翰共同開發的長效雙胰高血糖素受體 GLP-1 受體激動劑（也稱為 BI 456906）的 II 期項目的初步數據將於今年稍後公佈。 2 型糖尿病 II 期試驗的初始數據計劃於 9 月在歐洲糖尿病研究協會上公佈，強調該試驗的主要終點，即從基線到 16 週，糖化血紅蛋白治療相對於安慰劑的劑量關係。我們也與 BI 同事一起預計在 2022 年稍後的科學大會上介紹 2 型糖尿病試驗的次要終點，評估體重變化對體重的影響。

In summary, it has been an incredibly active, exciting and data-rich time for our clinical development programs, and the second half of the year looks to maintain the strong momentum across our entire research and development platform.

總而言之，對於我們的臨床開發項目來說，這是一個非常活躍、令人興奮和數據豐富的時期，下半年我們的整個研發平台有望保持強勁的勢頭。

Now, I will turn the call over to our CFO, Matt Dallas, to walk us through our half year financial results. Matt?

現在，我將把電話轉給我們的財務長馬特達拉斯 (Matt Dallas)，他將向我們介紹半年的財務表現。馬特？

Thanks, David.

謝謝，大衛。

In the first half of 2022, we initiated our organizational restructuring, taking steps to strengthen our financial future and ensuring that Zealand can continue to discover and develop innovative new peptide therapeutics.

2022 年上半年，我們啟動了組織重組，採取措施增強我們的財務前景，並確保西蘭能夠繼續發現和開發創新的新型勝肽療法。

In addition to the 90% workforce reduction implemented in the United States, in the second quarter, we amended our loan agreement with Oberland Capital and raised DKK 274.8 million in a direct private placement. With these events and the consolidation of the exchange listings as mentioned at the beginning of the call by Adam, the company is well positioned to execute on its strategy.

除了在美國實施90%的裁員之外，第二季我們還修改了與Oberland Capital的貸款協議，並透過直接私募籌集了2.748億丹麥克朗。透過這些事件以及亞當在電話會議開始時提到的交易所上市的整合，該公司已做好執行其策略的準備。

On Slide 7, you will see Zealand's income statement for the first 6 months of 2022 and how it compares to 2021. Total revenue for the first 6 months was DKK 43.5 million or USD 6.1 million. This was driven by net Zegalogue product revenue and partnership revenue from our collaboration with Alexion. The operating result for the period was a loss of DKK 539.2 million or USD 75.3 million.

在幻燈片 7 上，您將看到西蘭島 2022 年前 6 個月的損益表以及與 2021 年的比較。前 6 個月的總收入為 4,350 萬丹麥克朗或 610 萬美元。這是由 Zegalogue 產品淨收入以及我們與 Alexion 合作產生的合作夥伴收入所推動的。本期經營業績虧損 5.392 億丹麥克朗（7,530 萬美元）。

Sales and marketing costs were mainly related to the commercial infrastructure in the U.S. to support Zegalogue while R&D costs mainly -- primarily related to our late-stage clinical programs.

銷售和行銷成本主要與美國支持 Zegalogue 的商業基礎設施有關，而研發成本主要與我們的後期臨床項目有關。

As a result of our announced restructuring, all gross margin and operating expenses related to V-Go are accounted for as discontinued operations. Total discontinued operations for the first half of 2022 were a loss of DKK 97.9 million or USD 13.7 million.

由於我們宣布的重組，與 V-Go 相關的所有毛利率和營運費用均計為終止業務。 2022 年上半年終止經營業務總計虧損 9,790 萬丹麥克朗或 1,370 萬美元。

Slide 8 illustrates our financial position and ability to support our growing business through continued investments. Total operating expense for the period was DKK 577.4 million or USD 80.6 million. Included in the operating expenses for the period are DKK 75.8 million related to our announced restructuring. And cash on hand at the end of June 2022 was DKK 864.4 million or USD 120.7 million.

投影片 8 說明了我們的財務狀況以及透過持續投資來支持我們不斷成長的業務的能力。該期間的總營運費用為 5.774 億丹麥克朗（8,060 萬美元）。本期營運費用包括與我們宣布的重組相關的 7,580 萬丹麥克朗。截至 2022 年 6 月末，手頭現金為 8.644 億丹麥克朗（1.207 億美元）。

Turning to our financial guidance on Slide 9. The company anticipates that net product revenue from the sales of the Zegalogue is expected to be DKK 11.5 million, plus or minus 10%. This is a reduction of DKK 7.5 million from our updated guidance issued on May 12. With the completion of the asset purchase agreement for V-Go with MannKind Corporation, the company will no longer provide guidance on net product revenue associated with sales from that program.

轉向幻燈片 9 中的財務指引。該公司預計 Zegalogue 銷售的產品淨收入預計為 1,150 萬丹麥克朗，上下浮動 10%。這比我們 5 月 12 日發布的更新指導減少了 750 萬丹麥克朗。隨著與 MannKind Corporation 完成 V-Go 資產購買協議，該公司將不再提供與該計劃銷售相關的淨產品收入指導。

Zealand Pharma expects revenue from existing license agreements. However, since such revenue is uncertain in terms of size and timing, we do not intend to provide guidance on such revenue.

Zealand Pharma 預計從現有授權協議中獲得收入。然而，由於此類收入的規模和時間均不確定，因此我們不打算就此類收入提供指導。

Net operating expenses in 2022 are expected to be DKK 1 billion, plus or minus 10%. This is unchanged from our prior guidance, and is a decrease of DKK 200 million from the original guidance issued on March 10.

2022 年淨營運費用預計為 10 億丹麥克朗，上下浮動 10%。這與我們先前的指導意見沒有變化，但比 3 月 10 日發布的最初指導意見減少了 2 億丹麥克朗。

With that, I will now turn the call back to Adam.

現在，我將把電話轉回給亞當。

Thank you, Matt.

謝謝你，馬特。

As previously announced, Matt, he will be leaving Zealand by the end of August, and this will be his last quarterly call. I would therefore like to thank Matt for his leadership and many contributions over the last few years, and I wish him all the best with his next challenges.

正如 Matt 先前宣布的那樣，他將於 8 月底離開紐西蘭，這將是他最後一次季度電話會議。因此，我要感謝馬特在過去幾年中的領導和做出的許多貢獻，並祝福他在接下來的挑戰中一切順利。

In light of Matt's departure, we have been conducting a search for a new CFO for the company, and we expect to be able to make an announcement soon.

鑑於馬特的離職，我們一直在為公司尋找新的財務官，我們預計很快就能發佈公告。

Turning to Slide 10. The second quarter has delivered on several fronts, and we believe Zealand is now well positioned to leverage the value of our pipeline. We have some exciting months ahead of us with significant number of important milestones, which should further clarify the potential of our many new product opportunities.

轉向幻燈片 10。第二季度在多個方面取得了成果，我們相信紐西蘭現在處於有利地位，可以充分利用我們管道的價值。我們將迎來令人興奮的幾個月，將實現大量重要的里程碑，這將進一步闡明我們許多新產品機會的潛力。

Thank you all. I will now turn it over to the operator for questions.

謝謝你們。我現在將其交給接線員詢問。

(Operator Instructions) We are going to proceed with the first question. The first question comes from the line of Joseph Stringer from Needham & Company.

（操作員說明）我們將繼續第一個問題。第一個問題來自 Needham & Company 的 Joseph Stringer。

Heading into the SBS readout here, can you provide your thoughts just based on feedback from physicians, which efficacy endpoint is most important for potential widespread adoption or uptake in the SBS market? For example, from a registrational perspective, obviously, your primary endpoint is absolute changing PS. Gattex was approved on a -- in part on a different endpoint, the responder analysis greater than 20% PS reduction. But are there other key end points such as number of patients completely weaned off PS or change in other PS metrics that you would consider important from a potential commercial perspective?

在這裡進入 SBS 讀數，您能否僅根據醫生的回饋提供您的想法，哪個療效終點對於 SBS 市場的潛在廣泛採用或吸收最重要？例如，從註冊角度來看，顯然，您的主要終點是絕對變化的 PS。 Gattex 獲得批准的依據是——部分是基於不同的終點，響應者分析 PS 降低超過 20%。但是，從潛在的商業角度來看，是否還有其他關鍵終點（例如完全戒斷 PS 的患者數量或其他 PS 指標的變化）您認為很重要？

Yes. This is David Kendall. Thanks for the question.

是的。這是大衛肯德爾。謝謝你的提問。

And you very nicely summarized both what was part of the previous regulatory approval for teduglutide. And given the construct of our trials, obviously, the statistical power for registration is tied to a reduction in volume of parenteral support.

您很好地總結了特度魯肽先前監管批准的一部分。考慮到我們試驗的結構，顯然，註冊的統計功效與腸外支持量的減少有關。

And secondarily, looking at a similar proportion reduction in that parenteral support, but I think you also make a very important distinction, which is the potential to reduce the number of days on parenteral support, discontinuing parenteral support, either on a given day or a series of days, will be critically important.

其次，看看腸外支持的類似比例減少，但我認為你也做出了一個非常重要的區別，即有可能減少腸外支持的天數，停止腸外支持，無論是在某一天還是在某一天這一系列的日子將至關重要。

Obviously, powering the study for regulatory review based on the latter has its challenges, given that this is a rare disease, and having adequate numbers of subjects to demonstrate that with clarity or certainty could be challenging. However, we will be collecting just that in our clinical program to assess whether there are meaningful reductions in the days off of parenteral support.

顯然，鑑於這是一種罕見疾病，並且有足夠數量的受試者來清楚或確定地證明這一點可能具有挑戰性，因此基於後者為監管審查提供支持具有挑戰性。然而，我們將在我們的臨床計劃中收集這些數據，以評估腸外支持的休息天數是否有意義的減少。

So I think all 3 go well beyond just achieving a regulatory endpoint and are critically important, both to the burden of SBS, and ultimately, to the significant burden of days on parenteral support.

因此，我認為這三個因素遠遠超出了實現監管終點的範圍，而且對於 SBS 的負擔以及最終對於腸外支持的沉重負擔都至關重要。

We are going to proceed with the next question. The next question comes from the line of Lucy Codrington from Jefferies.

我們將繼續下一個問題。下一個問題來自 Jefferies 的 Lucy Codrington。

I've got a few. Just still on the glepaglutide Phase III and the expectations going into the data. So just in terms of setting our expectations, should we be looking at the kind of 1.6 to 2-liter reductions in parenteral nutrition volumes seen with Gattex in their Phase III and the 30% to 40% placebo-adjusted response rates are sensible bars for efficacy?

我有幾個。仍然是關於格列魯肽第三階段以及對數據的期望。因此，就設定我們的期望而言，我們是否應該考慮 Gattex 在 III 期試驗中看到的腸外培養量減少 1.6 至 2 公升，以及 30% 至 40% 的安慰劑調整反應率對於功效？

And then related to that, can you remind us of any stratification by remnant bowel anatomy in your trial? Does that differ to that used in the Gattex Phase III, and could that have any influence when we're looking at the data sets together with the caveats of cross-trial comparisons, of course? And are there any other differences between the Phase IIIs that we should be aware of?

與此相關，您能否提醒我們在您的試驗中透過殘餘腸解剖進行分層？這與 Gattex 第三階段使用的不同嗎？當然，當我們查看資料集以及交叉試驗比較的注意事項時，這會產生任何影響嗎？第三階段之間還有其他我們應該注意的差異嗎？

And I'll stop at this and jump back in the queue.

我會就此停下來並跳回到隊列中。

Very good. If I can test my short-term memory and recall those.

非常好。如果我可以測試我的短期記憶並回憶起那些。

I think your first question to the proportional response, if you will, in reduction of parenteral support. We know that glepaglutide, glepa, is a GLP-2 agonist just like teduglutide. So while these are not comparative studies, obviously, this is placebo-controlled, we would estimate that at least qualitatively, reductions that have been seen with the other GLP-2 receptor agonist would be those that we would expect. But obviously, to go further and try to predict at this point what those data may show would be both premature and speculative only. I think that is a reasonable starting point, certainly.

我認為你的第一個問題是關於減少腸外支持的比例反應（如果你願意的話）。我們知道格列魯肽，glepa，與替度魯肽一樣，是一種 GLP-2 激動劑。因此，雖然這些不是比較研究，但顯然這是安慰劑對照的，但我們估計至少在定性上，其他 GLP-2 受體激動劑所觀察到的減少將是我們所期望的。但顯然，此時進一步嘗試預測這些數據可能顯示的內容還為時過早，而且只是推測性的。我認為這當然是一個合理的起點。

And I think I wrote it down, but I've already lost the second half of that question.

我想我已經把它寫下來了，但我已經把那個問題的後半部分弄丟了。

Just whether there was any stratification by anatomy?

只是是否存在解剖學分層？

Yes. So we do have so-called CIC or colon-in-continuity subjects as well as stoma patients within the trial. But there is no a priori at least primary endpoint for assessing differences. But obviously, this will be a part of the secondary analyses that we will undertake. Obviously, understanding that those 2 populations can behave differently, particularly when it comes to completely withdrawing parenteral support.

是的。因此，我們在試驗中確實有所謂的 CIC 或結腸連續性受試者以及造口患者。但評估差異至少沒有先驗的主要終點。但顯然，這將是我們將進行的二次分析的一部分。顯然，要了解這兩個群體的行為可能有所不同，特別是在完全撤回腸外支持時。

So yes, that will be part of our analysis. It is not obviously part of the primary endpoint.

是的，這將是我們分析的一部分。它顯然不是主要終點的一部分。

And so just to be clear on the differences between those, you would expect those with continuity to respond less. Is that right?

因此，為了弄清楚它們之間的差異，您可能會期望那些具有連續性的人會做出更少的反應。是對的嗎？

Yes, correct.

是，對的。

Okay. Great. And then just my last question just relates to the dapiglutide obesity trial. I believe, from reading the press release, that it's going to be an investigator-sponsored study. Does that just reflect resource prioritization rather than you conducting the trials yourself?

好的。偉大的。我的最後一個問題與達匹魯肽肥胖試驗有關。透過閱讀新聞稿，我相信這將是一項由研究者資助的研究。這是否只是反映了資源優先級，而不是您自己進行的試驗？

I think it is not solely a resource utilization question. Obviously, there will be more than just efficacy endpoints and opportunity to explore mechanistic components of how the compound acts, which are obviously done most effectively in a well-established academic center, which does a trial looking at complex mechanistic responses to the incretin hormones.

我認為這不僅僅是一個資源利用問題。顯然，不僅僅是功效終點和探索化合物作用機制的機會，這顯然在一個完善的學術中心最有效地完成，該中心進行了一項試驗，研究對腸促胰島素激素的複雜機制反應。

So I think beyond some efficiencies of being able to initiate this earlier for a relatively more efficient cost in the setting of an investigator-led trial, it will also allow for that detailed look at potential mechanisms which may be at play for this very novel agent.

因此，我認為，除了能夠在研究者主導的試驗中以相對更有效的成本更早啟動這一點之外，它還可以詳細研究可能對這種非常新穎的藥物發揮作用的潛在機制。

(Operator Instructions) We have the next question coming from the line of Mike Novod from Nordea.

（操作員說明）我們有 Nordea 的 Mike Novod 的下一個問題。

It's Michael Novod from Nordea. So 3 questions. First of all, to the BI 45 compound, the GLP-1 glucagon coagonist. So I could see that the abstract is already titled in the abstract book, so maybe just to sort of gauge your confidence in the safety, because we have had a lot of discussions around glucagon safety. We've seen a publication by Novo with their glucagon compound [GLP-1] glucagon, which didn't sort of look too promising in terms of safety. So just gauging your confidence on the safety side, going into the EASD? I know you can't comment on the specific data.

我是來自 Nordea 的邁克爾諾沃德。所以 3 個問題。首先是 BI 45 化合物，GLP-1 胰高血糖素激動劑。所以我可以看到摘要已經在摘要書中有了標題，所以也許只是為了衡量您對安全性的信心，因為我們已經圍繞胰高血糖素安全性進行了很多討論。我們已經看到 Novo 發表的一篇關於他們的胰高血糖素化合物 [GLP-1] 胰高血糖素的出版物，從安全性角度來看，它看起來不太有希望。那麼，只是衡量您對 EASD 安全的信心嗎？我知道你不能對具體數據發表評論。

Then secondly, on Zegalogue, maybe, Adam, you can give a bit of extra color on the potential timing of a license deal for this asset?

其次，關於 Zegalogue，也許 Adam，您可以就該資產許可交易的潛在時間提供一些額外的資訊嗎？

And then lastly, also in respect to glepaglutide, how should we think about timing with regards to also a license deal on this, given that you are sort of progressing, if that is positive, towards submitting an NDA? I guess, a potential partner would like to be active on that side as well? Or how do you think about timing for glepa should data be positive?

最後，同樣就格魯肽而言，考慮到你們正在提交新藥申請（如果這是積極的），我們應該如何考慮有關許可協議的時機？我想，潛在的合作夥伴也想在這方面積極參與嗎？或者如果數據是正面的，您如何看待 glepa 的時機？

This is David. I'll start with the BI 456906 question and the safety profile.

這是大衛。我將從 BI 456906 問題和安全概況開始。

Obviously, Phase II is really the first more comprehensive look at efficacy and safety. And I think as you suggested, having the posted abstract for the BI compound is both exciting for us, and we look forward to seeing the full details of the glycemic outcomes at EASD. And I think it would be premature to further speculate on behalf of our BI partners on the comprehensive safety, but obviously, we fully expect that tolerability and safety will be detailed in that presentation.

顯然，第二階段確實是第一次更全面地考察功效和安全性。我認為正如您所建議的，發布 BI 化合物的摘要對我們來說都是令人興奮的，我們期待看到 EASD 血糖結果的完整細節。我認為代表我們的 BI 合作夥伴進一步推測綜合安全性還為時過早，但顯然，我們完全期望該簡報中詳細介紹耐受性和安全性。

But given that we've now completed that Phase II in the Type 2 population suggests that at least completion of the trial supports its utility. To go beyond that, I think I'd be getting ahead of the formal presentation and speculating on the safety outcomes.

但考慮到我們現在已經完成了 2 型人群的 II 期研究，表明該試驗的完成至少支持了其效用。除此之外，我想我應該在正式演示之前就對安全結果進行推測。

Yes.

是的。

And Michael, maybe also just to follow up on David's note here, which I completely agree with. I think at the American Diabetes Association meeting in June, BI did show some more details on the molecule, including the ratio of glucagon and GLP-1 and so on. I think you should be careful to compare across these molecules even though they are named glucagon or glucagon GLP-1 there could be different ratios and they're quite individual observations for each molecule. So I would also ask you to draw the attention to the presentation that BI made at the American Diabetes Association Meeting.

邁克爾，也許也只是為了跟進大衛的說明，我完全同意。我想在6月的美國糖尿病協會會議上，BI確實展示了該分子的一些更多細節，包括胰高血糖素和GLP-1的比例等等。我認為你應該小心地比較這些分子，即使它們被命名為胰高血糖素或胰高血糖素 GLP-1，也可能有不同的比率，並且它們是每個分子的非常單獨的觀察結果。因此，我也請您注意 BI 在美國糖尿病協會會議上所做的演講。

Then for Zegalogue, as I said, we are in advanced discussions. And I've said all the time that it's our ambition to complete a deal before we leave this quarter, and this is still the ambition for the company. And I think it's premature to comment more on this until we can announce something hopefully.

然後，對於 Zegalogue，正如我所說，我們正在進行深入討論。我一直在說，我們的目標是在本季離開之前完成交易，這仍然是公司的目標。我認為在我們有希望宣布一些事情之前對此發表更多評論還為時過早。

On the last one, for glepaglutide, we now -- really, the key focus for us is to get to the key results and then engage with FDA. And on the partnering front, our key focus right now is to complete our discussions on Zegalogue. And then we also have CHI, as you know, coming up. So it's not that we are in a hurry. We think we have our plans in a good place. And -- but -- as I've also shared in prior calls, we have had quite a significant inbound interest in the program. So we will kind of take it from there, but we will not advance these discussions until we have seen results for sure.

關於最後一項，對於格列魯肽，我們現在——實際上，我們的重點是獲得關鍵結果，然後與 FDA 合作。在合作方面，我們現在的重點是完成對 Zegalogue 的討論。如您所知，我們還將推出“CHI”。所以我們並不著急。我們認為我們的計劃處於一個很好的位置。而且——但是——正如我在之前的電話會議中所分享的那樣，我們對該計劃產生了相當大的興趣。因此，我們會從那裡開始，但在我們確實看到結果之前，我們不會推進這些討論。

We are going to proceed with the next question. The next question has come from the line of Thomas Bowers from Danske Bank.

我們將繼續下一個問題。下一個問題來自丹斯克銀行的托馬斯·鮑爾斯。

Yes. A couple of questions from my side here.

是的。我這邊有幾個問題。

So can you maybe just give us a little bit of color on the US delisting. So in terms of annual cost savings, so including fees and insurance and legal stuff? So that was the first question.

那麼您能否提供我們一些有關美國退市的資訊。那麼就年度成本節省而言，包括費用、保險和法律費用？這是第一個問題。

So just -- then just a follow-up on Zegalogue, can you maybe just remind us on the commercial commitments you have here now going into August? So is there anything that makes things a little bit more difficult for you? And also in addition to that, the recent (technical difficulty) infusion. So I'm just wondering whether you are maybe looking more into sort of an out-license with royalties compared to sort of a one-time upfront payment from just selling the asset?

那麼，作為 Zegalogue 的後續行動，您能否提醒我們您現在在 8 月所做的商業承諾？那麼有什麼事情讓你的事情變得更加困難嗎？除此之外，還有最近的（技術難度）輸注。所以我只是想知道，與僅出售資產的一次性預付款相比，您是否可能更多地考慮一種帶有特許權使用費的外部許可？

And then my last question, just on BI 45. Just wondering in regards to -- of course, we are all awaiting the Phase II, but I mean Boehringer, private company, they could also make a decision prior to those Phase II data and then go into -- or announce Phase III. So I'm just wondering if whether you have any information, or maybe even could potentially see Boehringer take that decision prior to the Phase II data, if that's possible?

然後是我的最後一個問題，關於BI 45。只是想知道——當然，我們都在等待第二階段，但我的意思是勃林格殷格翰，私人公司，他們也可以在這些第二階段數據之前做出決定，然後進入－或宣布第三階段。所以我只是想知道您是否有任何信息，或者甚至有可能看到勃林格殷格翰在第二階段數據之前做出這一決定，如果可能的話？

So maybe I will address the Zegalogue and BI, and then turn over the ADR question to Matt on the potential cost savings.

因此，也許我會向 Zegalogue 和 BI 發表講話，然後將 ADR 問題轉交給 Matt，了解潛在的成本節約問題。

But if we take BI, of course, you can say we would expect BI to inform us when they take that decision, and we will probably also inform the market if the decision will be taken on the initiation of Phase III. And we cannot comment further on when they will take this decision right now, if they will do it before or after, they have also seen the Phase II data from the obesity study. I remind you that it's a Type 2 diabetes study that is being presented at the EASD and also later this year. So -- but we do expect them to see the full data from the obesity study as well.

但如果我們採取 BI，當然，你可以說我們希望 BI 在做出決定時通知我們，如果在第三階段啟動時做出決定，我們也可能會通知市場。我們現在無法進一步評論他們什麼時候會做出這個決定，如果他們會在之前或之後做出，他們也看到了肥胖研究的第二階段數據。我提醒您，這是一項 2 型糖尿病研究，將於 EASD 以及今年稍後發表。所以——但我們確實希望他們也能看到肥胖研究的完整數據。

So this is really up for BI to decide, and then we will, of course, inform accordingly.

因此，這實際上是由 BI 決定的，然後我們當然會做出相應的通知。

For Zegalogue, I really can only -- you can say confirm that we are in advanced discussions. We are keeping the product on the market. We are supporting the product from all the regulatory, medical and supply aspects. We have very little sales support, as you can also see from the numbers now. So that has been -- that -- so it's completely in line with restructuring that we announced. And that's, of course, also why we have a key focus on completing a potential agreement before we leave the quarter. So -- and I can honestly not -- I will not comment more on the deals, potential deal structures (inaudible) at this time.

對於 Zegalogue，我真的只能——你可以說確認我們正在進行深入討論。我們將產品留在市場上。我們從所有監管、醫療和供應方面支持該產品。我們的銷售支援非常少，您也可以從現在的數字中看到。所以這完全符合我們宣布的重組。當然，這也是我們在本季結束之前專注於完成潛在協議的原因。所以——老實說我不能——我目前不會對交易、潛在的交易結構（聽不清楚）發表更多評論。

Matt, maybe over to you on the ADR, potential cost savings and...

馬特，也許關於 ADR、潛在的成本節約和…的問題就交給你了。

Right. Yes. We have not publicly stated what our exact expectations are on a per dollar basis, but I can tell you that the cost of maintaining the U.S. listing requires significant external legal and audit requirements due to the regulatory reasons. As well as significant internal time, cost and efforts in finance, legal, risk management.

正確的。是的。我們尚未公開說明我們對每美元的具體預期是多少，但我可以告訴您，由於監管原因，維持在美國上市的成本需要大量的外部法律和審計要求。以及財務、法律、風險管理方面的大量內部時間、成本和精力。

As this delisting takes place and occurs, we will see significant costs reduced from those areas as well as, again, from internal kind of focus as well.

隨著這種退市的發生和發生，我們將看到這些領域以及內部關注的成本顯著降低。

We are going to proceed with the next question. The next question comes from the line of Lucy Codrington from Jefferies.

我們將繼續下一個問題。下一個問題來自 Jefferies 的 Lucy Codrington。

Apologies. Just, if I may, is it possible to get an updated cash runway guidance now following the delisting and the debt restructure and the capital raise? And then in terms of potential near-term milestones that are not included in guidance, is there anything that we should be aware of that could be a possible near-term milestone?

道歉。只是，如果可以的話，在退市、債務重組和融資之後，現在是否有可能獲得更新的現金跑道指南？那麼，就未包含在指導中的潛在近期里程碑而言，我們是否應該注意哪些可能成為近期里程碑的事情？

Matt, will you start on this one?

馬特，你會開始做這件事嗎？

Yes. So right now, the current cash runway, and this is based on just as the company stands at this very moment, takes us into Q2 of 2023. This does not include potential Zegalogue partnerships. It does not include any future milestones such as from our partnerships with BI or Alexion, or any additional partnership cost savings from any of the other additional programs with obesity and SBS. It also includes the full burden of maintaining the delisting. The delisting has not been yet completed.

是的。因此，目前的現金跑道（這是基於公司目前的情況）將我們帶入 2023 年第二季。這不包括潛在的 Zegalogue 合作夥伴關係。它不包括任何未來的里程碑，例如我們與 BI 或 Alexion 的合作夥伴關係，或任何其他與肥胖和 SBS 相關的其他計劃節省的任何額外合作夥伴成本。它還包括維持退市的全部負擔。目前下市工作尚未完成。

So as we move into the next period and the updated guidance on that side, all of those costs will be filtered through and will be reflected in future announcements.

因此，當我們進入下一個時期以及這方面的更新指引時，所有這些成本都將被過濾並反映在未來的公告中。

We have no further questions at this time. I will now hand back the call to Mr. Adam Steensberg, CEO for closing remarks. Please go ahead.

目前我們沒有進一步的問題。現在我將把電話交回給執行長 Adam Steensberg 先生致閉幕詞。請繼續。

Okay.

好的。

With that, we would like to thank you all for attending and for your questions. We look very much forward to connecting on future announcement and updates. Have a good day.

在此，我們要感謝大家的出席和提出的問題。我們非常期待就未來的公告和更新進行聯繫。祝你有美好的一天。

This concludes today's conference call. Thank you for participating. You may now disconnect your lines.

今天的電話會議到此結束。感謝您的參與。現在您可以斷開線路。