Nyxoah SA (NYXH) 2024 Q2 法說會逐字稿

Good day, everyone, and thank you for standing by. Welcome to Nyxoah second-quarter 2024 earnings conference call. (Operator Instructions)

大家好，感謝你們的支持。歡迎參加 Nyxoah 2024 年第二季財報電話會議。（操作員說明）

Please be advised that today's conference is being recorded. I will pass the call over to your first speaker today, Mikaela Kirkwood.

請注意，今天的會議正在錄製中。我將把電話轉給今天第一位發言者米凱拉·柯克伍德 (Mikaela Kirkwood)。

Thank you, and good afternoon and good evening, everyone, and welcome to our earnings call for the second quarter and first half of 2024. I am Mikaela Kirkwood, Investor Relations and Communications Manager at Nyxoah. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and Loic Moreau, Chief Financial Officer.

謝謝大家，大家下午好、晚上好，歡迎參加我們 2024 年第二季和上半年的財報電話會議。我是 Mikaela Kirkwood，Nyxoah 的投資者關係和傳播經理。今天出席會議的有公司執行長 Olivier Taelman；和財務長盧瓦克·莫羅。

During the call, we will discuss our operating activities and review our second quarter financial results released after US market closed today, after which we will host a question-and-answer session. The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the Events section of the Investor Relations tab of our website.

在電話會議中，我們將討論我們的經營活動，並回顧今天美國市場收盤後發布的第二季財務業績，之後我們將舉行問答環節。新聞稿可以在我們網站的投資者關係部分找到。本次電話會議正在錄音，並將存檔在我們網站「投資者關係」標籤的「活動」部分。

Before we begin, I would like to remind you that any statements that relate to expectations or predictions of future events, market trends, results or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

在開始之前，我想提醒您，任何與未來事件、市場趨勢、結果或業績的預期或預測相關的陳述都是前瞻性陳述。所有前瞻性陳述均基於我們目前的估計和各種假設。這些陳述涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件有重大差異。

All forward-looking statements are based upon current available information and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. For a listed description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F filed with the Securities and Exchange Commission on March 20, 2024.

所有前瞻性陳述均基於當前可用信息，本公司不承擔更新這些陳述的義務。因此，您不應過度依賴這些陳述。有關與我們業務相關的風險和不確定性的列出描述，請參閱我們於 2024 年 3 月 20 日向美國證券交易委員會提交的 20-F 表格中的風險因素部分。

With that, I will now turn the call over to Olivier.

現在，我將把電話轉給奧利維爾。

Thank you, Mikaela. Good afternoon, and good evening, everyone, and thank you for joining us for our second quarter and first half of 2024 earnings call.

謝謝你，米凱拉。大家下午好，晚上好，感謝您參加我們的 2024 年第二季和上半年財報電話會議。

2024 is a pivotal year for Nyxoah with an increased focus on preparing for US market entry. In March this year, we announced of DREAM US pivotal study achieved its primary endpoints and demonstrated the Genio at the potential for best-in-class outcomes for OSA patients.

2024 年對 Nyxoah 來說是關鍵的一年，它更加重視為進入美國市場做準備。今年 3 月，我們宣布 DREAM US 關鍵研究實現了其主要終點，並證明 Genio 有潛力為 OSA 患者帶來一流的結果。

Subsequently, our regulatory team filed in the fourth and final module in our model of PMA submission, which has set the stage for FDA approval as early as the end of 2024. We strengthened recently our balance sheet with over EUR85 million in new capital raised, which extends our cash runway into mid-2026 and are actively building our US commercialization organization led by our recently hired new Chief Commercial Officer, Scott Holstine.

隨後，我們的監管團隊提交了 PMA 提交模型中的第四個也是最後一個模組，這為最早於 2024 年底獲得 FDA 批准奠定了基礎。我們最近透過籌集超過8500 萬歐元的新資本強化了我們的資產負債表，這將我們的現金跑道延長至2026 年中期，並正在積極建立由我們最近聘請的新任首席商務官Scott Holstine 領導的美國商業化組織。

Commercially, we reported first half 2024 European sales of EUR2 million, representing an increase of 29% from the first half of 2023 and ended the second quarter with 55 active implanting accounts in Germany.

在商業方面，我們報告 2024 年上半年歐洲銷售額為 200 萬歐元，較 2023 年上半年增長 29%，截至第二季末，德國有 55 個活躍植入帳戶。

To recap DREAM, the study has two primary endpoints of AHI respond rate [basis] criteria at 12 months and ODI respond rate at 12 months. At baseline, subjects had a mean AHI of 28 and an ODI of 27 and a body mass index of 28.5.

回顧 DREAM，研究有兩個主要終點：12 個月時的 AHI 回應率[基礎]標準和 12 個月時的 ODI 回應率。在基線時，受試者的平均 AHI 為 28，ODI 為 27，體重指數為 28.5。

On an intent-to-treat or ITT basis, the DREAM study shows an AHI respond rate of 63.5% with a p-value of 0.002 and an ODI respond rate of 71.3% with a p-value less than 0.001. With these strong results, the DREAM study met its primary endpoints. Additionally, subjects demonstrated a median 12-month AHI reduction of 70.8% with similar AHI improvements in supine and non-supine sleeping positions.

在意圖治療或 ITT 基礎上，DREAM 研究顯示 AHI 反應率為 63.5%，p 值為 0.002，ODI 反應率為 71.3%，p 值小於 0.001。憑藉這些強有力的結果，DREAM 研究達到了其主要終點。此外，受試者的 12 個月 AHI 中位數降低了 70.8%，仰臥和非仰臥睡姿的 AHI 改善類似。

The safety results were favorable with 11 serious adverse events or SAEs in 10 subjects resulting in an SAE rate of 8.7%. Out of the 11 serious adverse events, 3 were device-related and there was 3 explants. We will present the full DREAM data at a lunch symposium at the ISSS conference in Miami, end of September, or September 27 to be precise and look forward to see many of you there.

安全性結果良好，10 名受試者發生 11 起嚴重不良事件或 SAE，SAE 比率為 8.7%。在 11 起嚴重不良事件中，3 起與設備相關，其中 3 起與外植體有關。我們將在 9 月底，確切地說是 9 月 27 日在邁阿密舉行的 ISSS 會議午餐研討會上展示完整的 DREAM 數據，並期待在那裡見到你們中的許多人。

The DREAM results further [proved] Genio as it was the first hypoglossal nerve stimulation study to require patients to sleep at least 60 minutes in the supine position and demonstrate strong efficacy that patients sleeping supine and non-supine, just like mimicking a normal night of sleep. This is of particular importance since published data show increased OSA severity when a patient is on his back or in a supine position with AHI doubling in supine versus the level position.

DREAM結果進一步[證明]了Genio，因為這是第一個要求患者仰臥位睡眠至少60分鐘的舌下神經刺激研究，並證明了患者仰臥和非仰臥睡眠的強大功效，就像模仿正常的夜晚一樣睡覺。這一點特別重要，因為已發表的數據顯示，當患者仰臥或仰臥位時，OSA 嚴重程度會增加，且仰臥位時的 AHI 比平臥位時的 AHI 加倍。

On average, people sleep 35% to 40% on their back during normal night or standard nights, which was in line with our PSG findings in DREAM. This means that irrespective of a patient's sleeping position, Genio maintains its efficacy and that is unique. Based on feedback from the physicians, this will be very impactful on therapy selection. It supports our mission to make sleep simple again and we have applied for the inclusion of the supine efficacy results into our label. With the positive DREAM results, we have completed our model of PMA submission.

平均而言，在正常夜間或標準夜間，人們有 35% 至 40% 的仰臥睡眠時間，這與我們在 DREAM 中的 PSG 研究結果一致。這意味著無論患者的睡姿如何，Genio 都能保持其獨特的功效。根據醫生的回饋，這將對治療選擇產生非常大的影響。它支持我們讓睡眠再次變得簡單的使命，我們已申請將仰臥功效結果納入我們的標籤中。憑藉積極的 DREAM 結果，我們已經完成了 PMA 提交模型。

We have responded to all the FDA questions on the first three modules thus far and submitted the fourth and final module. Based upon model of PMA review cycle times, we anticipate FDA approval in late 2024 as we do not control FDA timelines, early 2025.

到目前為止，我們已經回答了 FDA 關於前三個模組的所有問題，並提交了第四個也是最後一個模組。根據 PMA 審查週期時間模型，我們預計 FDA 將於 2024 年底批准，因為我們無法控制 FDA 時間表，即 2025 年初。

In anticipation of the FDA approval, we are actively building our US commercial organization. In July, Scott Holstine joined Nyxoah as Chief Commercial Officer, after 26 years in the medical device industry.

為了獲得 FDA 的批准，我們正在積極建立我們的美國商業組織。在醫療器材行業工作了 26 年後，Scott Holstine 於 7 月加入 Nyxoah 擔任首席商務官。

In addition to Scott, key leadership in sales, marketing and market access are in place and we are actively kicking off the recruitment of top sales and marketing talent. At launch, we will target the Tier 1 [target] non-stimulation implant in sites in the US that accounts for 85% of all procedures done in the US. The organization will be composed of territory sales managers, supported by field engineers and field specialists, each with their own responsibilities.

除了斯科特之外，銷售、行銷和市場准入方面的關鍵領導層也已就位，我們正在積極招募頂尖的銷售和行銷人才。在推出時，我們將針對美國站點的 1 級[目標]非刺激植入，占美國所有手術的 85%。該組織將由區域銷售經理組成，並由現場工程師和現場專家提供支持，每個人都有自己的職責。

The territory sales managers will be the owner of the territory revenue, interacting with surgeons and field doctors. Field engineers and field specialists will be focused on high-quality implants and patient outcomes on the other hand. The advantage of this structure is that it's focused and scalable, providing territory managers the ability to drive increased therapy penetration without the distraction of covering implants and performing titrations.

地區銷售經理將成為地區收入的所有者，與外科醫生和現場醫生互動。另一方面，現場工程師和現場專家將專注於高品質的植入物和患者的治療結果。這種結構的優點在於它具有針對性和可擴展性，使區域管理人員能夠提高治療滲透率，而無需因覆蓋植體和執行滴定而分心。

Consequently, we can have more focused DTC helping territory managers locally increase patients refer for a Genio implant. Independent market research and feedback from (inaudible) nerve stimulation implant surgeons in the US who participated in our recent usability study reinforced Genio's differentiation versus current AG&S technology in terms of invasiveness, patient centricity, safety and the simplicity to treat OSA patients regardless of their sleep position.

因此，我們可以讓 DTC 更有針對性，幫助本地區域管理人員增加轉診 Genio 植體的患者數量。參與我們最近可用性研究的美國（聽不清楚）神經刺激植入外科醫生的獨立市場研究和反饋強化了Genio 與當前AG&S 技術在侵入性、以患者為中心、安全性以及治療OSA 患者（無論其睡眠如何）方面的差異化位置。

Genio offers patients (inaudible) full-body 1.5 and 3 Tesla MRI-compatible, non-implanted battery solution, both and controlled biowearable component. Of this and of an implant for life concept powered and controlled by the wearable component allows patients to always have the most advanced technology without the need for another surgery.

Genio 為患者（聽不清楚）提供全身 1.5 特斯拉和 3 特斯拉 MRI 相容的非植入電池解決方案，以及受控生物可穿戴組件。由可穿戴組件驅動和控制的生命植入概念使患者始終擁有最先進的技術，而無需再次進行手術。

Given these characteristics, we expect Genio to be market expanding in the US as a significant number of hypoglossal nerve stimulation candidates currently are declining base major based platform technology due to concerns over invasiveness and having an implantable battery in their chart. This view is supported by independent surveys demonstrating that over 20% of the US hypoglossal nerve stimulation candidates of turning down existing technology and strong interest in sisterly Genio and form factor.

鑑於這些特徵，我們預計 Genio 將在美國擴大市場，因為由於擔心侵入性和圖表中包含植入式電池，大量舌下神經刺激候選人目前正在拒絕基於主要平台技術。這一觀點得到了獨立調查的支持，該調查表明，超過 20% 的美國舌下神經刺激候選者拒絕現有技術，並對姐妹 Genio 和外形有濃厚興趣。

Going back to Europe. First half 2024 sales was EUR2 million, representing an increase of 29% from the first half of 2023 and we ended June with 55 active implanting accounts. As a reminder, Germany is our commercial proof of concept. Although the German market has some different characteristics than the US market, there are key learnings that will help us in developing a successful US commercialization strategy.

回到歐洲。2024 年上半年銷售額為 200 萬歐元，較 2023 年上半年成長 29%，截至 6 月，我們有 55 個活躍植入帳戶。提醒一下，德國是我們的商業概念證明。儘管德國市場與美國市場有一些不同的特徵，但一些重要的經驗教訓將幫助我們制定成功的美國商業化策略。

Similar to the US market, the German market is highly concentrated. And Genio was embraced by doctors and patients in those Tier 1 of top accounts, resulting in an acceleration in the hypoglossal nerve stimulation market growth.

與美國市場類似，德國市場也高度集中。Genio 受到了一級頂級客戶的醫生和患者的歡迎，從而加速了舌下神經刺激市場的成長。

Of the top 10 accounts, 9 are currently implanting Genio and in 5, we have at least 30% market share after 24 months. This is a strong [indication] for the US launch, where we will initially focus on the top implanting Tier 1 accounts. To continue to drive growth into these accounts, establishing a referral pathway with top sleep specialists focused on CPAP quitting patients and converting them in a timely manner will be a key to sustain success. The ResMed Nyxoah collaboration should confirm this strategy in the coming quarters.

在排名前 10 名的帳戶中，有 9 個目前正在植入 Genio，而在 5 個帳戶中，我們在 24 個月後擁有至少 30% 的市場份額。這是在美國推出的一個強烈[跡象]，我們將首先專注於頂級植入的一級帳戶。為了繼續推動這些客戶的成長，與專注於 CPAP 戒斷患者的頂級睡眠專家建立轉診途徑並及時將其轉變將是保持成功的關鍵。ResMed Nyxoah 合作應該會在未來幾季確認這項策略。

In summary, with strong DREAM data, a differentiated AG&S system and a cash runway into mid-2026, it could not be more excited for the future of Nyxoah.

總之，憑藉強勁的 DREAM 數據、差異化的 AG&S 系統以及到 2026 年中期的現金跑道，我們對 Nyxoah 的未來感到無比興奮。

With that, I'm pleased to turn the call over to our CFO, Loic Moreau, who will provide a financial update.

至此，我很高興將電話轉給我們的財務長 Loic Moreau，他將提供最新的財務資訊。

Thank you, Olivier. Good day to everyone, and thank you for joining us today. Revenue for the second quarter ended June 30, 2024, was EUR780,000. Total operating loss for the second quarter was EUR13.3 million versus EUR11.9 million in the second quarter of 2023, driven by an acceleration in commercial investments in US as well as in Europe.

謝謝你，奧利維爾。祝大家有美好的一天，感謝您今天加入我們。截至 2024 年 6 月 30 日的第二季營收為 78 萬歐元。由於美國和歐洲商業投資加速，第二季的總營運虧損為 1,330 萬歐元，而 2023 年第二季為 1,190 萬歐元。

During the second quarter, we raised over EUR85 million in gross capital through to EUR48.5 million equity offering and a loan facility agreement with the European Investment Bank for EUR37.5 million. This extends our cash runway to mid-2026.

第二季度，我們透過股票發行籌集了超過 8,500 萬歐元的總資本，達到 4,850 萬歐元，並與歐洲投資銀行達成了 3,750 萬歐元的貸款融資協議。這將我們的現金跑道延長至 2026 年中期。

As of June 30, 2024, cash and financial assets totaled EUR78 million. This excludes the first EUR10 million tranche of the EMV launch, which drew down in July. Finally, our monthly cash burn was EUR4 million for the quarter.

截至2024年6月30日，現金及金融資產總額為7,800萬歐元。這不包括 EMV 啟動的第一筆 1000 萬歐元，該資金於 7 月減少。最後，本季我們每個月的現金消耗為 400 萬歐元。

This concludes the formal part of our presentation. Operator, I will turn the call over to you to begin our Q&A session.

我們演講的正式部分到此結束。接線員，我將把電話轉給您，開始我們的問答環節。

(Operator Instructions) Suraj Kalia with Oppenheimer.

（操作員指示）Suraj Kalia 和奧本海默。

Pardon the background noise, it's raining pretty heavily here. So Olivier, congrats on all the progress in the modular PMA submission. Let me turn the direction to Germany, Olivier, if I could. It's been more than four quarters you all have been in Germany. What are the lessons learned from Germany? Is that translatable to the US? Is it or has it been a market that has met your expectations? And maybe if you could talk about other discussions about supine versus non-supine in Germany?

請原諒背景噪音，這裡雨下得很大。Olivier，祝賀模組化 PMA 提交取得的所有進展。如果可以的話，讓我把方向轉向德國，奧利維爾。你們來德國已經四個多季度了。德國的經驗教訓是什麼？這可以翻譯到美國嗎？現在或曾經是符合您期望的市場嗎？也許您能談談在德國有關仰臥與非仰臥的其他討論嗎？

Okay. Thank you for the question, Suraj. So first of all, when we look at the journey of launch goals were to demonstrate proof of concept by, one, breaking the monopoly that has currently hypoglossal nerve stimulation; and, two, expanding the hypoglossal nerve stimulation market. Those two objectives we have accomplished. Now all things, to your point, where we see the European experience is showing our ability to take share.

好的。謝謝你的提問，蘇拉傑。因此，首先，當我們審視發射過程時，目標是透過以下方式來證明概念驗證：第一，打破目前舌下神經刺激的壟斷；二是擴大舌下神經刺激市場。我們已經實現了這兩個目標。現在，就你的觀點而言，我們看到歐洲的經驗表明我們有能力分享。

Just as a reminder, we had 27% German market share for the second year of the launch. I think that is also something that exceeded our expectations. In mind, the German accounts of implanting Genio and we estimate that we go minimum above 30% and in some of those top 10 we are the market leader after 24 months. So that is also a very complete learning that will give us -- that is giving us confidence on the US launch.

提醒一下，我們在推出的第二年就佔了 27% 的德國市場。我想這也是超乎我們預期的事情。考慮到德國植入 Genio 的情況，我們估計我們的比例至少會超過 30%，並且在前 10 名中的一些中，我們在 24 個月後成為市場領導者。因此，這也是一個非常完整的學習，它將帶給我們——這讓我們對在美國的推出充滿信心。

And also, the fact that we see in Germany based on independent survey data, but also done and talking in attracting the patients that we see that there is over 20% of it also nerve stimulation candidates that are declining a base major due to the invasiveness of the procedure on the system. And therefore, Genio can further expand the market. So, so far, so good. I think those are the learnings.

而且，我們在德國看到的事實是基於獨立調查數據，而且在吸引患者方面也做了和談論，我們看到其中有超過 20% 的神經刺激候選人由於侵入性而拒絕基礎專業系統上的程序。因此，Genio可以進一步擴大市場。所以，到目前為止，一切都很好。我認為這些就是教訓。

That being said, let's also be very open on this. Germany still is a very small revenue market and there is still the potential for quarter-to-quarter variability, driven by a limited number of accounts implanting and implant volume. But if you look at -- and we feel that it's more accurate looking at our performance in the first half of the year, where we still are up to almost 30% versus the first half.

話雖這麼說，但我們也應該對此持開放態度。德國仍然是一個非常小的收入市場，由於植入帳戶數量和植入數量有限，仍然存在季度間波動的可能性。但如果你看一下——我們覺得更準確地看一下我們今年上半年的表現，與上半年相比，我們的表現仍然高達近 30%。

So I do think, overall, we are pleased with what we see in Germany. We take the lessons helping us prepare for a successful US launch. And also as a last reminder, the positive feedback in Germany since we were able to release the DREAM data is definitely helping us in driving future growth. So I think that was the first question. Yes.

所以我確實認為，總的來說，我們對在德國看到的情況感到滿意。我們汲取經驗教訓，幫助我們為在美國的成功發布做好準備。最後提醒一下，自從我們能夠發布 DREAM 數據以來，德國的積極反饋無疑有助於我們推動未來的成長。所以我認為這是第一個問題。是的。

And Olivier, for my follow-up question. Maybe I missed it in your prepared remarks on the status of the ACCESS trial. And also for the US, as you plan out for your commercial launch, the 31 sites that you referenced, how would you characterize the volume that these 31 sites do, and the rest you would need?

奧利維爾，回答我的後續問題。也許我在您準備好的關於 ACCESS 試驗狀態的評論中漏掉了這一點。同樣對於美國，當您計劃商業發佈時，您提到的 31 個站點，您如何描述這 31 個站點的容量以及您需要的其餘站點？

Yes. So the 31 sites to start with the end of your question, those are all high-volume implanters or implanted that of what we call the Tier 1 AG&S implanters in the US. So that is the first part. Second part, when it comes to ACCESS. So we continue to make progress with the study.

是的。因此，從您問題的末尾開始，這 31 個站點都是大容量植入者或我們在美國稱為 Tier 1 AG&S 植入者的植入者。這是第一部分。第二部分，談到ACCESS。因此，我們的研究繼續取得進展。

We are not disclosing the number of patients implanted, but that said, we plan to close implants by the end of 2024. I do not want to go back to Germany on this. But as you know, in Europe, we have see integrated in our level and the response that we are getting there is that also physicians are confirming similar results for CCC patients as well non-CCC patients. So this also is giving a confirmation that bilateral simulation is a key differentiator when it comes to treating successfully CCC patients.

我們沒有透露植入的患者數量，但我們計劃在 2024 年底前關閉植入。我不想就此回到德國。但如您所知，在歐洲，我們已經看到我們的水平得到了整合，我們得到的反應是，醫生也確認了 CCC 患者和非 CCC 患者的類似結果。因此，這也證實了雙邊模擬是成功治療 CCC 患者的關鍵差異因素。

Ed White, H.C. Wainwright.

懷特，H.C.溫賴特。

Olivier, maybe you could just tell us about your US reimbursement strategy?

Olivier，也許您可以告訴我們您在美國的報銷策略嗎？

Yes. No, no, definitely. First of all, I'm really excited that we are having these questions because it also means that we are getting extremely close to launching in the US. Now as I already mentioned in the previous earnings call, we are partnering with the American Association of Otolaryngology, the AAO, which will make a formal recommendation on established what they call bridge category 1 CPT code for use at launch. And I think this is so important that at launch, we have of CPT codes in place.

是的。不，不，絕對是。首先，我真的很高興我們有這些問題，因為這也意味著我們非常接近在美國推出。現在，正如我在之前的財報電話會議中提到的，我們正在與美國耳鼻喉科協會(AAO) 合作，該協會將就已建立的所謂橋接類別1 CPT 代碼提出正式建議，以便在發佈時使用。我認為這非常重要，以至於在發佈時我們就已經制定了 CPT 代碼。

That is not the final code, but it's the bridging code. And in parallel, of course, we are pursuing a geo-specific CPT code or time. But based on precedent, we know that this likely will take a little bit longer, even up to a couple of years. No.

這不是最終代碼，但它是橋接代碼。當然，同時，我們正在追求特定於地理的 CPT 代碼或時間。但根據先例，我們知道這可能需要更長的時間，甚至長達數年。不。

That being said, at launch and I keep coming back to this and assisting doctors will submit Medicare claims using the bridge Category 1 CPT code, which is currently covered by all Medicare administrative contractors on the MAX.

話雖這麼說，在發佈時，我不斷回到這一點，協助醫生將使用橋接類別 1 CPT 代碼提交 Medicare 索賠，該代碼目前由 MAX 上的所有 Medicare 管理承包商覆蓋。

Reimbursements will be in line with current AG&S payment rates. And I think that this is the most important update for today. No, to be really complete and we have to give credit to our competitors because they have done a terrific job educating the commercial payers about the benefits of hypoglossal nerve stim resulting in all having AG&S coverage policies in place.

報銷將按照目前的 AG&S 付款率進行。我認為這是今天最重要的更新。不，為了真正完整，我們必須讚揚我們的競爭對手，因為他們在教育商業付款人了解舌下神經刺激的好處方面做得非常出色，從而使所有人都制定了 AG&S 承保政策。

We have enrolled in the FDA only payer feedback program and we are conducting payer advisory interviews. We are already engaged in an informal discussion with the payers and we expect to be able to leverage those policies at launch.

我們已加入 FDA 唯一的付款人回饋計劃，並且正在進行付款人諮詢訪談。我們已經與付款人進行了非正式討論，我們希望能夠在推出時利用這些政策。

Jon Block, Stifel.

喬恩·布洛克，斯蒂菲爾。

This is Joe Federico on for Jon Block. I guess just to start maybe on the revenue result in the quarter. That was a bit below what we were modeling and that follows stronger revenue results in the fourth quarter of last year and last quarter. During that time, your competitor was also having some regulatory dynamic issues. And I just wanted to ask for some additional clarity. Now that they've kind of sorted that out this quarter, rather took a step back, do you think that played a role in kind of the revenue dynamics for this quarter?

我是喬‧費德里科 (Joe Federico)，代表喬恩‧布洛克 (Jon Block)。我想首先要從本季的收入結果開始。這略低於我們的模型，這是在去年第四季和上一季強勁的收入結果之後實現的。在此期間，您的競爭對手也遇到了一些監管動態問題。我只是想進一步澄清一下。現在他們已經在本季度解決了這個問題，而不是退一步，您認為這對本季的收入動態起到了一定的作用嗎？

Yes. So first of all, let me start by saying that competition is good for the market. It's always nice to have two options to choose for physicians and for patients. And it also keeps everyone sharp and really making sure that we can provide the latest and greatest technology and then upgrade to patients. Well, I have to repeat a little bit what I was offering to Suraj.

是的。首先，我要說的是，競爭對市場有利。對於醫生和患者來說有兩個選擇總是好的。它也讓每個人保持敏銳，真正確保我們能夠提供最新、最好的技術，然後升級給患者。好吧，我必須重複我向蘇拉傑提供的內容。

Germany still stays overall a very small revenue market if you look at the total AG&S market. So that is one aspect. And therefore, potential [given] variability driven by limited numbers of an implant volume is the case and it's a fact. That is correct. Now going back and assuming that because of product shortage of issue with competition in Q4, this would have strengthened our Q4 results.

如果你看看整個 AG&S 市場，德國總體上仍然是一個非常小的收入市場。這是一方面。因此，由有限數量的植體體積驅動的潛在[給定]變異是事實，也是事實。這是正確的。現在回過頭來假設，由於第四季度的競爭導致產品短缺問題，這將加強我們第四季的業績。

I think it's not completely true because if I'm well informed, I do think there was quite some inventory of products in Germany, especially with the top accounts to continue having also competition and counting in Q4.

我認為這並不完全正確，因為如果我消息靈通的話，我確實認為德國有相當多的產品庫存，特別是頂級客戶在第四季度繼續進行競爭和計數。

Overall, we see that the market of AG&S keeps growing strong. I think that's a confirmation of all this. And of course, without providing new guidance, it's also clear that we anticipate revenue in the second half of '24 to increase over the second half of '23. But as mentioned, quarter-to-quarter sales are hard to forecast.

總體而言，我們看到 AG&S 市場持續強勁成長。我認為這就是對這一切的證實。當然，在不提供新指引的情況下，我們預計 24 年下半年的營收將比 23 年下半年有所成長。但如同前面提到的，季度銷售額很難預測。

But given the process in the third quarter just for also the collaboration with ResMed on identifying new patients that are including their CPAP and actively converting them, it's something that maybe took a little bit longer than we expected, but we do see the results and we are more than excited also to see the impact of this on our revenue in the second half '24.

但考慮到第三季與 ResMed 的合作，識別使用 CPAP 的新患者並積極改變他們的治療方式，這可能比我們預期的時間要長一點，但我們確實看到了結果，我們也非常興奮地看到這對我們24 年下半年收入的影響。

Okay. Great. That's helpful color. And then just a quick follow-up. You had said that FDA approval for Genio could come as early as year-end '24. Is your expectation to get approval by year-end '24? Or could that maybe flip into early 2025? And then could you remind us just the number of sales reps you're targeting upon the eventual US launch and maybe training centers in the first 12 months?

好的。偉大的。這是有用的顏色。然後進行快速跟進。您曾說過 FDA 最快可能在 2024 年底批准 Genio。您預計在 24 年底前獲得批准嗎？或者這可能會轉變到 2025 年初？然後您能否提醒我們，您在最終在美國推出產品時所瞄準的銷售代表數量以及前 12 個月內的培訓中心數量？

Yes, definitely. So to your point, we have more of P&A. You know that after you submit the fourth and final module, that is the 180 days time clock that is currently activated. I can already share that there is a lot of activities from FDA that we have very positive engagement with them, so forth. And if you then do simply the math, we should be good to have FDA approval by the end of 2024.

是的，絕對是。所以就你的觀點而言，我們有更多的 P&A。您知道，在提交第四個也是最後一個模組後，即當前啟動的 180 天時鐘。我已經可以分享 FDA 開展的許多活動，我們與他們進行了非常積極的接觸，等等。如果你簡單算一下，我們應該會在 2024 年底前獲得 FDA 的批准。

So we are still very confident that this will happen. However, I want to be a little bit prudent in the sense that I'm not controlling FDA time line completely. So that's why sometimes we're also mentioning up to early '25. But if you just stick to the math, we see the interaction, all the work has been done, the files have been submitted, everything -- interactive reviews, ongoing site visits taking place. So we are fairly confident that by the end of this year, we could have FDA approval.

所以我們還是非常有信心這件事會發生。然而，我想謹慎一點，因為我並沒有完全控制 FDA 的時間表。這就是為什麼有時我們也會提到 25 年初。但如果你只專注於數學，我們會看到交互，所有工作都已完成，文件已提交，一切 - 交互式評論，正在進行的現場訪問。因此，我們非常有信心在今年年底前獲得 FDA 的批准。

No, the second part of the question is like how would we launch. I think I already elaborated a little bit how important it is for us to work with territory managers fully focused on revenue and patient referral. And next to them, we would have field engineers fully focus on high-quality implants, sleep specialists fully focused on post-implant patient follow-up and titration.

不，問題的第二部分是我們如何啟動。我想我已經詳細闡述了與完全專注於收入和患者轉診的區域經理合作對我們來說是多麼重要。在他們旁邊，我們將讓現場工程師完全專注於高品質植入，睡眠專家完全專注於植入後患者的隨訪和滴定。

So numbers, we will start and we will make our approach scalable since we are focused on the Tier 1 accounts in the US on the high-volume side and we will start with 15 territory managers. They are under the lead of one sales vice president that we already have onboard. Then all 15, there will be another 15 in total field engineers and field specialists focused on the patients.

因此，我們將從數字開始，使我們的方法具有可擴展性，因為我們專注於美國大容量的一級客戶，並且我們將從 15 名區域經理開始。他們由我們已有的一位銷售副總裁領導。那麼這 15 名現場工程師和現場專家總共有 15 名，他們專注於患者。

So in summary, our sales leadership is in place. We will go for a scalable approach with 15 territory managers only focused on revenue and driving new patients and they will be supported with in total 15 field engineers and 3 [managers].

總而言之，我們的銷售領導力已經就位。我們將採用可擴展的方法，由 15 名區域經理只專注於收入和吸引新患者，他們將得到總共 15 名現場工程師和 3 名[經理]的支持。

Ross Osborn, Cantor Fitzgerald.

羅斯·奧斯本，康托·菲茨杰拉德。

Starting off, I would be curious to hear how your manufacturing ramp efforts are progressing ahead of US launch. Do you believe you'll have sufficient scale to meet demand in 2025?

首先，我很想知道你們在美國推出之前的生產提升工作進展如何。您認為您的規模足以滿足 2025 年的需求嗎？

So the short answer is yes, we do believe we have significant demand. As you also know that we have currently of Genio 2.1 version. That is the one that we are using commercially in Europe. And it allows us to have stimulation trimming to be adjusted at small increments to provide patients sensitive to stimulation more options. And then also of patients' daily feedback using an app and even the autonomy to adjust stimulation.

所以簡短的回答是肯定的，我們確實相信我們有很大的需求。如您所知，我們目前有 Genio 2.1 版本。這就是我們在歐洲商業使用的那種。它允許我們以小增量調整刺激微調，為對刺激敏感的患者提供更多選擇。然後還有患者使用應用程式的日常回饋，甚至是調整刺激的自主權。

That is our current product that we have and that we are using commercially in Europe and that we also use currently in our studies. Now we already have our 3.1 generation with ceramic encapsulation of the internal component, making Genio an implant for life, a more ergonomic activation chip that will contain the coil, improving gross margins at eco-friendliness and a patient hub, which will be the base for close connectivity and advanced feedback.

這是我們目前擁有的產品，我們正在歐洲進行商業使用，目前也在我們的研究中使用。現在我們已經有了3.1 代產品，其內部組件採用陶瓷封裝，使Genio 成為終身植入物、更符合人體工學的激活晶片，其中將包含線圈，提高生態友好性的毛利率和患者中心，這將成為基礎實現緊密連接和進階回饋。

With this product, we are planning to launch in the US with FDA approval and also the area manufacturing lines set up in the US with the service provider and also in Europe and going forward so that we have also derisk to our manufacturing and increased our capacity in the US and also outside of the US.

透過該產品，我們計劃在獲得 FDA 批准的情況下在美國推出，並與服務提供者一起在美國建立區域生產線，並在歐洲繼續推進，以便我們也降低生產風險並提高我們的產能在美國以及美國境外。

Okay. Great. And then one modeling question. Looking at OpEx and anticipating an inflection ahead of the US launch, should we think of that as more of a 3Q or a 4Q activity?

好的。偉大的。然後是一個建模問題。看看營運支出並預計在美國推出之前會出現拐點，我們是否應該將其視為更多的第三季或第四季活動？

We -- so yes, if you look at the cash -- the shape of the cash flow, we expect the -- an inflection that will start in Q3 because as Olivier was saying, we have started to recruit the management for the US organization. And we will have the first rate. So yes, the cash burn will start to increase in Q3 and continue to increase in Q4. So it will be a steady increase that we expect in the second half of the year before the sales start in Q1 next year.

我們 - 所以是的，如果你看看現金 - 現金流的形狀，我們預計 - 變化將在第三季度開始，因為正如奧利維爾所說，我們已經開始為美國組織招聘管理層。我們將擁有一流的。所以，是的，現金消耗將在第三季開始增加，並在第四季繼續增加。因此，我們預計在明年第一季開始銷售之前，下半年將穩定成長。

Okay. Great. And then lastly and I realize it's early on, but following the hiring of Scott, how do you shape your commercialization plan for the US launch?

好的。偉大的。最後，我意識到現在還為時過早，但在聘請斯科特之後，您如何制定在美國推出的商業化計劃？

So next to Scott, we have also hired a sales leader. We have hired our marketing leader of reimbursements of market access leaders. We are finalizing a search for a human resource US or global leader. We are also looking at nonoperational director.

因此，除了斯科特之外，我們還聘請了一位銷售主管。我們聘請了我們的行銷負責人報銷市場准入負責人。我們正在最終尋找一位美國或全球人力資源領導者。我們還在尋找非營運董事。

And then we also started actively recruiting our sales force. And what really, really I -- gave me great confidence is just seeing the high number of spontaneous applications that we are getting. And I do not want to, I mean, start throwing in numbers that it's really a high number of people reaching out that want to be part of the Nyxoah team that we'll be launching in the US.

然後我們也開始積極招募我們的銷售人員。真正給我很大信心的是看到我們收到的大量自發性申請。我的意思是，我不想開始透露確實有很多人願意加入我們將在美國推出的 Nyxoah 團隊。

David Rescott, Baird.

大衛雷斯科特，貝爾德。

Great. I want to clarify a couple of pieces. I heard some numbers being thrown around and I've been up around calls as well. So I want to make sure I'm hearing everything correctly. I thought in the last call you had talked about maybe the 75 to 100 higher-volume centers.

偉大的。我想澄清幾件事。我聽到一些號碼被亂扔，我也一直在打電話。所以我想確保我聽到的一切都是正確的。我想在上次通話中您可能談到了 75 到 100 個容量較大的中心。

Again, I may have totally heard it wrong this quarter, but I heard the number 31. I kind of called out there, I also heard you're looking to go after where about 85% of the volumes in the US are occurring. So can you just help kind of clarify what may be the near intermediate and then kind of longer-term go-to-market account opening strategy is in the US?

再說一次，我這個季度可能完全聽錯了，但我聽到了數字 31。我有點呼籲，我還聽說你們正在尋找美國大約 85% 的交易量發生的地方。那麼，您能否幫助澄清一下在美國可能採取的近期和長期市場開戶策略是什麼？

Apologies if things were not completely clear, but let me try to make it clear. So the Tier 1 accounts that I was referring to were the surgeons have participated in our usability study and have provided a feedback.

如果事情不完全清楚，我深表歉意，但讓我試著說清楚。因此，我所指的一級帳戶是外科醫生參與了我們的可用性研究並提供了回饋。

Just as a reminder, they were trained on the product from an autonomic perspective, from a implant perspective in both animal and cadavers. And then within 24 hours, they have to reproduce an implant in the cadaver independently. And their overall feedback was extremely positive and they were really waiting and asking when this technology would be available for them to be used in their accounts.

提醒一下，他們從自主的角度、從動物和屍體的植入角度接受了產品的訓練。然後，他們必須在 24 小時內獨立在屍體上複製植入物。他們的整體反饋非常積極，他們真的在等待並詢問這項技術何時可以在他們的帳戶中使用。

That's the 31 number. The other numbers I was referring to, I'm always saying we focus on Tier 1 accounts. If you look at the Tier 1 accounts in total below representing 85% of all hypoglossal nerve stimulation revenue, we are talking about 200 to 250 accounts in the US. Out of this number, we will be focusing on 150 from the beginning. We will be doing this in a scalable approach, meaning with our 15 sales rep in quarter 1 of launch, they will go after the first, let's say, 50 to 75 accounts.

那是31號。我提到的其他數字，我總是說我們專注於一級帳戶。如果您看一下下面總共佔所有舌下神經刺激收入 85% 的 1 級帳戶，我們談論的是美國的 200 到 250 個帳戶。在這個數字中，我們將從一開始就關注 150 個。我們將以可擴展的方法來做到這一點，這意味著我們在發布的第一季有 15 名銷售代表，他們將追隨第一批（比如說 50 到 75 個）客戶。

And every quarter, the number of accounts will increase until we reach also the 200-plus Tier 1 top implanting accounts and in parallel of course, we will increase also our number of territory managers, field engineers and sleep specialists. I hope this is more clarifying your question.

每個季度，帳戶數量都會增加，直到我們達到 200 多個一級頂級植入帳戶，當然，我們也會同時增加區域經理、現場工程師和睡眠專家的數量。我希望這能更澄清你的問題。

Yes. That's great. Maybe just on -- you heard some of the comments on the P&L, the cash balance where you're at today and how the ramp maybe should look over the next couple of years, that mid-'26 cash runway. Have you kind of thought about what that longer-term kind of breakeven profit numbers look like? I know it's still pretty far away, but just wondering if we were to model out over the next three to four years, how we should be thinking about the rest of the P&L?

是的。那太棒了。也許就在——你聽到了一些關於損益表、你今天的現金餘額以及未來幾年的成長情況的評論，即 26 年中期的現金跑道。您是否想過長期的損益兩平利潤數字是什麼樣的？我知道這還很遙遠，但只是想知道如果我們要在未來三到四年內進行建模，我們應該如何考慮損益表的其餘部分？

Thank you for the questions. As discussed during the call, our US launch strategy will be focused at scalable. We will initially target the top AG&S account and selectively invest in DCC to drive patient referrals. With our commercial structure, the territory manager will be supported by field engineers and field sleep specialists, which will enable a highly productive commercial organization.

謝謝你的提問。正如電話會議中所討論的，我們的美國發布策略將側重於可擴展性。我們最初將瞄準頂級 AG&S 帳戶，並選擇性地投資 DCC 以推動患者轉診。透過我們的商業結構，區域經理將得到現場工程師和現場睡眠專家的支持，這將實現高效的商業組織。

That's what we have in mind. So with this approach, we anticipate achieving profitability at around $250 million of sales in the US. So that's what we have in mind.

這就是我們的想法。因此，透過這種方法，我們預計在美國實現約 2.5 億美元銷售額的盈利。這就是我們的想法。

And I think in addition, two comments, if I can add. For us, it was crucial also to have a healthy balance sheet that is fully standing the US launch. We have this because of the acuity base in combination with the loan facility, we are now having more than EUR85 million added to our existing balance sheet. I think it is also giving us some contracts to fully focus on the execution of the launch.

我想另外還有兩則評論，如果我可以補充的話。對我們來說，擁有健康的資產負債表也至關重要，足以承受美國的推出。我們之所以能做到這一點，是因為我們的敏銳度基礎與貸款便利性相結合，我們現有的資產負債表上現在增加了超過 8500 萬歐元。我認為它也給了我們一些合同，讓我們能夠完全專注於發布的執行。

Adam Maeder, Piper Sandler.

亞當梅德，派珀桑德勒。

This is [James] on for Adam. Just one. I wanted to give you guys the opportunity to comment on the SURMOUNT-OSA study that was recently released at ADA. We were just curious to get your reaction to that data, and if there's been any change to how you guys are thinking about GLP-1s and the impact on your business?

這是亞當的[詹姆斯]。只有一個。我想讓你們有機會評論 ADA 最近發布的 SURMOUNT-OSA 研究。我們只是想知道您對這些數據的反應，以及您對 GLP-1 的看法以及對您業務的影響是否有任何變化？

From [ADA], we welcome GLP-1s overall because it will definitely help increase also the total OSA market and patient numbers to treat. What we learned if I go a little bit more in depth is that if we look at the data, we see a placebo-adjusted 50% reduction in AHI and an 80% reduction in BMI coming out of the SURMOUNT-OSA data.

從 [ADA] 來看，我們總體上歡迎 GLP-1，因為它肯定有助於增加 OSA 市場總量和需要治療的患者數量。如果我更深入一點的話，我們會發現，如果我們查看數據，我們會發現 SURMOUNT-OSA 數據顯示，經過安慰劑調整後，AHI 降低了 50%，BMI 降低了 80%。

The recent data demonstrate in the placebo-adjusted reduction in OSA, severity and magnitude of OSA reduction that was below those shown by hypoglossal nerve stimulation, I think that's also very important to point mode. And then last, both published data and commentary from the leading KOLs indicate that to have the highest hypoglossal nerve stimulation response or therapeutic effect, it is best to lower BMI and bring it below 35 than to treat high BMI patients.

最近的數據表明，安慰劑調整後的 OSA 降低、OSA 降低的嚴重程度和幅度低於舌下神經刺激所顯示的結果，我認為這對於點模式也非常重要。最後，已發表的數據和主要 KOL 的評論都表明，為了獲得最高的舌下神經刺激反應或治療效果，最好降低 BMI 使其低於 35，而不是治療高 BMI 患者。

And in that perspective, the SURMOUNT data reinforce our view that GLP-1s will increase the hypoglossal nerve stimulation patient funnel as in the GLP-1 only on AHI went from 50 to 22 with a BMI from 39 to 32 and that gives us great confidence, as I was saying in the beginning and we welcome therefore also GLP-1s into the market.

從這個角度來看，SURMOUNT 數據強化了我們的觀點，即GLP-1 將增加舌下神經刺激患者漏斗，因為僅在GLP-1 中，AHI 從50 增加到22，BMI 從39 增加到32，這給了我們很大的信心正如我一開始所說的，因此我們也歡迎 GLP-1 進入市場。

Thank you. As I see no further questions in the queue, I will conclude the session and conference for today. Thank you all who participated and you may now disconnect. Thank you, everyone.

謝謝。由於我在隊列中沒有看到更多問題，我將結束今天的會議。感謝所有參與的人，現在您可以斷開連接了。謝謝大家。