Nyxoah SA (NYXH) 2023 Q3 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Nyxoah's Third Quarter 2023 Earnings Conference Call. (Operator Instructions) Please be advised that today's call is being recorded.

美好的一天，感謝您的支持。歡迎參加 Nyxoah 2023 年第三季財報電話會議。 （操作員說明）請注意，今天的通話正在錄音。

I would now like to hand the conference over to your first speaker today, Mikaela Kirkwood, Investor Relations and Corporate Communications Manager. Please go ahead.

現在我想將會議交給今天的第一位發言人，投資者關係和企業傳播經理米凱拉·柯克伍德 (Mikaela Kirkwood)。請繼續。

Good afternoon, and good evening, everyone, and welcome to our earnings call for the third quarter of 2023. I am Mikaela Kirkwood, Investor Relations and Corporate Communications Manager at Nyxoah. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and Loic Moreau, Chief Financial Officer.

大家下午好，晚上好，歡迎參加我們 2023 年第三季的財報電話會議。我是 Mikaela Kirkwood，Nyxoah 的投資者關係和企業傳播經理。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 third quarter financial results released after U.S. 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，並回顧今天美國股市收盤後發布的第三季財務業績，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. 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 list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section on our Form 20-F filed with the Securities and Exchange Commission on March 22, 2023.

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。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清單和描述，請參閱我們於 2023 年 3 月 22 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 third quarter 2023 earnings call.

謝謝你，米凱拉。大家下午好，晚上好，感謝您參加我們的 2023 年第三季財報電話會議。

During the third quarter, we maintained focus on clinical execution in our open-label U.S. pivotal study dream, ensuring a steady course to complete data readout in March 2024. Based upon the DREAM data published back in June, in combination with commercial patient outcomes in Europe, our confidence is strengthened for a positive DREAM outcome. In anticipation of our U.S. launch, we have made great progress as we continue to work with the AAO on our interim and long-term coding strategy.

在第三季度，我們繼續關注開放標籤美國關鍵研究夢想的臨床執行，確保穩步完成 2024 年 3 月的數據讀出。基於 6 月份發布的 DREAM 數據，結合 2020 年的商業患者結果歐洲，我們對實現正向的夢想成果的信心增強。預計我們將在美國推出，隨著我們繼續與 AAO 合作制定我們的中期和長期編碼策略，我們已經取得了巨大進展。

Next, we continue to invest in gradually building our leadership in the U.S. commercial organization, including market access to facilitate reimbursement. In Europe, we recently introduced a novel patient-centric approach by initiating a partnership with ResMed Germany. Together, we will strengthen our in-depth understanding of the obstructive sleep apnea patients' journey, increasing patient overall OSA awarness and guiding them from diagnosis to treatment. While CPAP remains the golden standard, there is a large pool of patients not tolerating it and needing therapy due to the severity of their OSA. Through this partnership, we aim to increase hypoglossal nerve stimulation penetration and accelerate Genio adoption.

接下來，我們將繼續投資，逐步建立我們在美國商業組織中的領導地位，包括促進報銷的市場准入。在歐洲，我們最近與德國 ResMed 建立了合作夥伴關係，推出了一種以患者為中心的新型方法。我們將共同加強對阻塞性睡眠呼吸中止症患者歷程的深入了解，提高患者對 OSA 的整體認知並指導他們從診斷到治療。雖然 CPAP 仍然是黃金標準，但仍有大量患者無法耐受它，並且由於 OSA 的嚴重程度而需要治療。透過這種合作關係，我們的目標是提高舌下神經刺激的滲透率並加速 Genio 的採用。

Now, with that said, Nyxoah is entering one of the most exciting times in the company's history. In less than 6 months, we will report data from our DREAM U.S. pivotal trial. We recently filed the third module in our model of PMA and continue to anticipate submitting the fourth and final module. Which will include DREAM 12-month safety and efficacy data, shortly after the follow-up period is completed. We remain on track for FDA approval before the end of 2024.

現在，Nyxoah 正在進入公司歷史上最令人興奮的時代之一。在不到 6 個月的時間內，我們將報告 DREAM 美國關鍵試驗的數據。我們最近在 PMA 模型中提交了第三個模組，並繼續預計提交第四個也是最後一個模組。其中將包括追蹤期結束後不久的 DREAM 12 個月安全性和有效性數據。我們仍有望在 2024 年底前獲得 FDA 批准。

In anticipation of this, Nyxoah continues to expand its U.S. footprint. (inaudible) remains on patient follow-up in DREAM. As previously stated, our confidence in DREAM outcomes is supported not only by the roughly 500 commercial and clinical Genio (inaudible), but also by the DREAM efficacy safety data released in a late-breaking poster session at SLEEP 2023 in June. In the poster, we reported efficacy data on the first 34 DREAM patients reaching 12 months follow-up. Which demonstrated a 65% AHI responder rate and the 76% ODI responder rate and safety data on all 115 patients enrolled in the study. As a reminder, for the trial to be successful of the 115 patients, at least 62.9% need to be AHI and ODI responders a 12-month follow-up.

預計到這一點，Nyxoah 繼續擴大其在美國的足跡。 （聽不清楚）仍在 DREAM 中對患者進行追蹤。如前所述，我們對 DREAM 結果的信心不僅得到了大約 500 個商業和臨床 Genio（聽不清）的支持，還得到了 6 月 SLEEP 2023 最新海報會議上發布的 DREAM 功效安全數據的支持。在海報中，我們報告了前 34 名 DREAM 患者追蹤 12 個月的療效數據。結果顯示，所有 115 名參與研究的患者的 AHI 反應率為 65%，ODI 反應率為 76%。提醒一下，為了讓 115 名患者的試驗成功，至少 62.9% 的患者需要在 12 個月的追蹤中對 AHI 和 ODI 有反應。

Next, the U.S. ACCESS pivotal study focused on complete concentric collapse patients continues to enroll with implants expected to be completed in 2024. As a reminder, CCC patients represent approximately 30% of hypoglossal nerve stimulation eligible to treat OSA patients, who are contraindicated to commercially available HGNS therapy in the U.S. and do not have suitable treatment options other than major pellet surgery. The ACCESS primary endpoints are similar to the DREAM study primary endpoints as Genio has demonstrated similar results in both complete concentric collapse and non-CCC patients, which resulted in a label expansion in Europe.

接下來，專注於完全同心塌陷患者的美國ACCESS 關鍵研究繼續招募植入物，預計將於2024 年完成。需要提醒的是，CCC 患者約佔適合治療OSA 患者的舌下神經刺激患者的30%，這些患者在商業上是禁忌的美國沒有可用的 HGNS 療法，除了大型顆粒手術外沒有合適的治療選擇。 ACCESS 主要終點與 DREAM 研究主要終點相似，因為 Genio 在完全同心塌陷和非 CCC 患者中都顯示出類似的結果，這導致了歐洲的標籤擴展。

While entering Germany, Nyxoah drove hypoglossal nerve stimulation awareness and therapy penetration, increasing market growth from an estimated 15% to 35% over the last 2 years. This clearly illustrates the benefit of having multiple hypoglossal nerve stimulation treatment options and having multiple companies on the market.

在進入德國時，Nyxoah 提高了舌下神經刺激意識和治療滲透率，在過去 2 年中將市場成​​長率從估計的 15% 提高到 35%。這清楚地說明了擁有多種舌下神經刺激治療方案和市場上擁有多家公司的好處。

To further our patient-centric approach to treating more OSA patients with the right solution, as I mentioned earlier, we partnered with ResMed Germany. This model partnership creates an OSA continuum of care that will shorten the time from diagnosis to treatment and ensure patients are not left without an appropriate therapy. As an example, there are approximately 1.1 million CPAP patients in Germany, of which up to 35% fail within 3 years. This collaboration should increase the number of patients in Germany receiving and staying under OSA therapy.

正如我之前提到的，為了進一步推進我們以患者為中心的方法，用正確的解決方案治療更多 OSA 患者，我們與 ResMed 德國合作。這種合作模式創建了 OSA 連續護理，將縮短從診斷到治療的時間，並確保患者不會無法獲得適當的治療。例如，德國約有 110 萬名 CPAP 患者，其中高達 35% 在 3 年內失敗。這項合作應該會增加德國接受和持續接受 OSA 治療的患者數量。

Completely, to increase patient awareness, we will collaborate to OSA outlines and DTC marketing initiatives. We will run joint sales force efforts towards ENT surgeons, sleep physicians and dentists as well as educational programs. Both companies will work closely with scientific societies to further optimize patient care guidelines. In conclusion, this initiative exemplifies our mission to make sleep simple again.

為了提高患者意識，我們將完全配合 OSA 綱要和 DTC 行銷計劃。我們將針對耳鼻喉科醫生、睡眠醫生和牙醫開展聯合銷售工作以及教育計劃。兩家公司將與科學協會密切合作，進一步優化患者護理指南。總之，這項措施體現了我們讓睡眠再次變得簡單的使命。

Commercially, this quarter, we reported sales of EUR 1 million and increased the number of German centers implanting Genio to 46. Our direct-to-consumer campaigns started in the second quarter this year, resulted in a strong website traffic with approximately 55,000 monthly website visits. We are anticipating the first results from these initiatives already in Q4 later this year with strong year-over-year implant growth. We continue to position ourselves as an innovation leader in the OSA space with always putting patients at the center and listening to our surgeons.

在商業方面，本季我們的銷售額為100 萬歐元，並將植入Genio 的德國中心數量增加到46 個。我們的直接面向消費者的活動於今年第二季度開始，帶來了強勁的網站流量，每月約有55,000 個網站造訪。我們預計這些舉措將在今年第四季取得初步成果，植入量將實現強勁的年成長。我們繼續將自己定位為 OSA 領域的創新領導者，並始終以患者為中心，傾聽外科醫生的意見。

As a result, Genio has a different approach to HGNS, compared to an existing implanted battery with lead solution technology. Genio offers patients a leadless full-body 1.5 tesla and 3 tesla MRI compatibility. Non-implanted battery solutions powered and controlled biowearables. Our vision of an implant for life concept powered and controlled biowearable component allows patients to always have the most advanced technology without the need for another surgery.

因此，與採用鉛溶液技術的現有植入電池相比，Genio 採用了不同的 HGNS 方法。 Genio 為患者提供無引線全身 1.5 特斯拉和 3 特斯拉 MRI 相容性。非植入電池解決方案為生物穿戴裝置供電和控制。我們對生命植入概念動力和控制的生物可穿戴組件的願景是讓患者始終擁有最先進的技術，而無需再次進行手術。

Independent patient market research confirm preference for a system with Genio features and foreign factor. The recently launched Genio 2.1 wearable enables greater stimulation adjustability and gives patients the autonomy to adjust stimulation amplitude within predefined boundaries. While the Genio 3.1 implantable stimulator is under regulatory review and will further report our implants for life concept.

獨立的患者市場研究證實了對具有 Genio 功能和外國因素的系統的偏好。最近推出的 Genio 2.1 穿戴式裝置可實現更大的刺激可調節性，並讓患者在預先定義的範圍內自主調整刺激幅度。 Genio 3.1 植入式刺激器正在接受監管審查，並將進一步報告我們的植入式生命概念。

We are also working on regulatory approval to activate existing sensors in the wearable component that will adjust stimulation based upon sleeping position. Future generations of the Genio system will provide patients with real-time feedback through data collection and also remote monitoring that will improve the patient experience and provide physicians the ability to optimize patient care more efficiently. All this should further increase patient access to hypoglossal nerve stimulation technology and have a positive impact on the company's gross margin.

我們也正在努力獲得監管部門的批准，以激活可穿戴組件中的現有感測器，該感測器將根據睡眠位置調整刺激。未來幾代 Genio 系統將透過數據收集和遠端監控為患者提供即時回饋，從而改善患者體驗，並使醫生能夠更有效地優化患者護理。所有這些都將進一步增加患者獲得舌下神經刺激技術的機會，並對公司的毛利率產生正面影響。

Our European commercialization experience early DREAM data and Genio's differentiated design, reinforce our confidence in a successful U.S. launch. We commissioned independent clinician and patient service, which demonstrates significant demand for Genio and support our view that we can more than replicate our European performance when entering commercially in the U.S. To ensure we are fully prepared that launch, we continue to invest in our U.S. commercial infrastructure and securing reimbursement. Last month, an advisory panel for the ENT scientific society discussed the CPT code that will best support Genio. While (inaudible) outcome of this meeting, we expect reimbursement to be at the minimum in line with the current HGNS payment rates in the U.S..

我們在歐洲的商業化經驗、早期的 DREAM 數據和 Genio 的差異化設計增強了我們對在美國成功推出的信心。我們委託了獨立的臨床醫生和患者服務，這表明對Genio 的巨大需求，並支持我們的觀點，即在進入美國商業市場時，我們不僅可以複製我們在歐洲的表現。為了確保我們為上市做好充分準備，我們繼續投資於我們的美國商業市場基礎設施​​和確保報銷。上個月，ENT 科學協會的顧問小組討論了最能支持 Genio 的 CPT 代碼。雖然本次會議的（聽不清楚）結果，但我們預計報銷金額將至少符合美國目前的 HGNS 支付率。

Finally, we are making steady progress with our ansa cervicalis program through our exclusive licensing agreement with the Vanderbilt University. Under the lead of Professor David Kent and close collaboration with Nyxoah R&D team, we are evaluating stimulation of the ansa cervicalis nerve to address current HGNS nonresponders. We have ended the detailed design phase and anticipate beginning a feasibility study shortly.

最後，透過與范德比爾特大學的獨家授權協議，我們的頸蚴計畫正在穩步取得進展。在 David Kent 教授的領導下並與 Nyxoah 研發團隊密切合作，我們正在評估刺激頸袢神經以解決當前 HGNS 無反應者的問題。我們已經結束了詳細設計階段，預計很快就會開始可行性研究。

In summary, we continue to advance our key objectives for 2023, which are to focus on patient follow-up in the DREAM study resulting in reaching the primary endpoints, begin preparations to enter the U.S. market with regulatory, manufacturing, commercial and market access readiness and drive further revenue growth in Germany while opening new European markets. To that end, we implanted our first patients in Italy.

總之，我們繼續推進 2023 年的關鍵目標，即重點關注 DREAM 研究中的患者隨訪，從而達到主要終點，開始為進入美國市場做好監管、製造、商業和市場准入準備推動德國收入進一步增長，同時開拓新的歐洲市場。為此，我們在義大利植入了第一批患者。

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 third quarter ended September 30, 2023 was EUR 1 million. Total operating loss for the third quarter was EUR 11 million versus EUR 8.8 million in the third quarter of 2022, driven by an acceleration in clinical activities as well as commercial investments in Europe. As of September 30, 2023, cash and financial assets totaled EUR 73 million, compared to EUR 95 million on December 31, 2022. During the third quarter, our monthly cash burn was EUR 4 million. And based on our current cash position, we have a runway into late 2024.

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 2023 年 9 月 30 日的第三季營收為 100 萬歐元。由於歐洲臨床活動和商業投資的加速，第三季的總營運虧損為 1,100 萬歐元，而 2022 年第三季為 880 萬歐元。截至 2023 年 9 月 30 日，現金及金融資產總額為 7,300 萬歐元，而 2022 年 12 月 31 日為 9,500 萬歐元。第三季度，我們每月的現金消耗為 400 萬歐元。根據我們目前的現金狀況，我們有一個到 2024 年底的機會。

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

這樣，我會將電話轉回給奧利維爾。

Thank you, Loic. As I opened with, we are entering one of the most exciting times in Nyxoah's history. I cannot emphasize this enough. We are less than 6 months away from the DREAM clinical data readout, which should result in obtaining FDA approval in late '24, and initial (inaudible) with reimbursement comparable to competition. The uniqueness of Genio system resonates well with both physicians and patients as well (inaudible) The Germany and other markets where we are available, also confirmed by independent market research.

謝謝你，洛伊克。正如我開頭所說，我們正在進入尼克索亞歷史上最令人興奮的時代之一。我怎麼強調都不為過。距離 DREAM 臨床數據讀出還有不到 6 個月的時間，這應該會在 24 年末獲得 FDA 的批准，初步（聽不清楚）報銷與競爭對手相當。 Genio 系統的獨特性也引起了醫生和患者的共鳴（聽不清楚）德國和我們提供服務的其他市場，這也得到了獨立市場研究的證實。

I look forward to continuing to scale the company in anticipation of U.S. market and continuing to grow in Europe.

我期待根據美國市場的預期繼續擴大公司規模，並繼續在歐洲發展。

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) Our first question today comes from Jon Block with Stifel.

（操作員說明）今天我們的第一個問題來自 Jon Block 和 Stifel。

This is Joe Federico on for Jon. I guess to start, I wanted to ask, I know GLP-1 has been a hot topic lately. Do you have any expectations for the surmount OSA data that is supposed to be released early next year? We've heard some commentary from other players in the space. I was just curious to get your thoughts there.

我是喬費德里科 (Joe Federico)，替喬恩 (Jon) 發言。我想首先我想問一下，我知道 GLP-1 最近是一個熱門話題。您對明年初發布的OSA海量數據有什麼期待嗎？我們聽到了該領域其他參與者的一些評論。我只是好奇想知道你的想法。

Yes. No. Thank you for the question. And to confirm, there was a lot of -- there is a lot of conversation around GLP-1 impact. So I keep giving the same and providing the same answers, meaning that by having GLP-1's lowering extreme high BMIs, we think, and we know that we will have more patients that will become eligible for a successful HGNS treatment. Because if we look at literature, HGNS is shown the most effective with the BMI up to 35. So high BMIs lowering in the range of 30 to 35 will provide those patients with an optimal treatment of HGNS. And if you look at it net-net, we do believe that we will have more patients entering in that range, then we will have patients that will go in the range below 15 and no longer be eligible for treatment.

是的。不，謝謝你的提問。為了確認這一點，有許多圍繞 GLP-1 影響的討論。因此，我一直給出相同的答案，這意味著透過 GLP-1 降低極高的 BMI，我們認為並且我們知道我們將有更多的患者有資格接受成功的 HGNS 治療。因為如果我們看文獻，HGNS 在 BMI 高達 35 時最有效。因此，將高 BMI 降低到 30 至 35 範圍內將為這些患者提供最佳的 HGNS 治療。如果你仔細觀察，我們確實相信會有更多的患者進入該範圍，然後我們將有患者進入低於 15 的範圍並且不再有資格接受治療。

Okay. Great. That's really helpful color. And I guess to follow up, I just wanted to follow up on the ResMed partnership in the quarter. There is -- what are you seeing after implementing that partnership? Is it still early to tell? Or have you seen any benefits from that so far in Germany?

好的。偉大的。這真是有用的顏色。我想跟進一下，我只是想跟進本季與瑞思邁的合作關係。在實施這種夥伴關係之後，您看到了什麼？現在說還早嗎？或者到目前為止，您在德國看到過這方面的好處嗎？

So through the partnership, we aim to further our patient-centric approach by developing a complete OSA ecosystem where patients can be guided to which OSA therapy best suited the need. I think this is really important. We will collaborate on DTC initiatives, sales and marketing efforts to target both sleep physicians and ENT surgeons. The goal of this partnership or to expand OSA therapy penetration and increased market shares. The collaboration just kicked off, and we expect to start to see the benefit beginning next year.

因此，透過此次合作，我們的目標是透過開發完整的 OSA 生態系統來進一步推進我們以患者為中心的方法，在該生態系統中，可以指導患者選擇最適合其需求的 OSA 治療方法。我認為這非常重要。我們將在 DTC 計劃、銷售和行銷工作方面進行合作，以針對睡眠醫生和耳鼻喉科醫生。此次合作的目標也是擴大 OSA 治療的滲透率並增加市場佔有率。合作才剛開始，我們預計從明年開始就能看到效益。

Okay. Great. That makes sense. And then if I could just sneak one last one in here. On ACCESS in the U.S. Are there any other data points from the trial that you can provide, maybe patients implanted to date or number of active sites? Just any more color there would be great.

好的。偉大的。這就說得通了。如果我能偷偷溜進這裡最後一張就好了。關於美國的 ACCESS 您是否可以提供該試驗的任何其他數據點，也許是迄今為止植入的患者或活性部位的數量？只要有更多的顏色就太好了。

No. So when it comes to the ACCCESS study, we are staying confident that we will close the enrollment by the end of 2024. So that's why -- that's when we anticipate completing the implants. We continue to make progress with the study. We will not be disclosing the number of patients implanted. But that being said, I repeat myself, we do feel confident that we will close all implants by the end of 2024.

不會。因此，當涉及到 ACCCESS 研究時，我們對將在 2024 年底之前結束招募充滿信心。這就是原因 - 那時我們預計會完成植入。我們的研究持續取得進展。我們不會透露植入的患者數量。但話雖這麼說，我再說一遍，我們確實有信心在 2024 年底前關閉所有植入物。

Our next question is from Adam Maeder with Piper Sandler.

我們的下一個問題來自 Adam Maeder 和 Piper Sandler。

Olivier, Loic. This is Simran on for Adam. I guess, first, I wanted to just start off with the Q3 kind of commercial print. So could you elaborate on maybe what you're seeing in terms of just commercial trends? It looks like volumes did take a step back sequentially. So any particular items to call out or seasonality impact. I guess I'm just trying to reconcile some of the disconnect between what the Street was expecting versus the print.

奧利維爾、盧伊克.這是西姆蘭（Simran）為亞當（Adam）發言。我想，首先，我想從第三季的商業印刷開始。那麼能否詳細說明一下您所看到的商業趨勢？看起來成交量確實是依序後退了一步。因此，任何需要指出的特定項目或季節性影響。我想我只是想調和華爾街的預期與印刷品之間的一些脫節。

Yes. No, no, definitely. So while we do not provide revenue guidance, it is important to mention that the third quarter is seasonally weak due to summer holidays. However, for implanting accounts continued to increase, now being 46, which bodes well for the future growth. We do anticipate also a sequential increase in the fourth quarter, driven by the DTC initiatives that we started in the second quarter, driven by the helpline outcome that we are seeing. And of course, although it may become a little bit early, but also about the collaboration that we have initiated with ResMed.

是的。不，不，絕對是。因此，雖然我們不提供收入指引，但值得注意的是，由於暑假，第三季季節性疲軟。然而，植入帳戶持續增加，目前已達 46 個，預示著未來的成長。我們確實預計第四季度也會出現環比增長，這得益於我們在第二季度啟動的 DTC 計劃，以及我們所看到的幫助熱線結果的推動。當然，雖然現在可能有點早，但也是關於我們與 ResMed 發起的合作。

Our next question comes from Ed White with H.C. Wainwright.

我們的下一個問題來自 Ed White 和 H.C.溫賴特。

So I just want to get your thoughts on the DTC activity in Germany. You mentioned in the call that you had about 55,000 monthly hits. And I was just wondering how you're thinking about that converting into commercial sales? And then I wanted to get your thoughts also on DTC -- potential DTC activity in the U.S.

我只想了解您對德國 DTC 活動的看法。您在電話中提到您的每月點擊量約為 55,000 次。我只是想知道您如何考慮將其轉化為商業銷售？然後我想了解您對 DTC 的看法——DTC 在美國的潛在活動。

Yes. So thank you. Thank you for the questions. So to your point (inaudible) in dedicating and building up a dedicated digital marketing team focused on Germany as we launched the Nyxoah helpline in Germany last year. We engaged resources in the search engine optimization and the search engine advertising. This is really driving more patients to Nyxoah. So that's already a first part of investment we did.

是的。所以謝謝。謝謝你的提問。因此，正如您所說（聽不清楚），我們去年在德國推出了 Nyxoah 幫助熱線，並專門建立了一支專注於德國的數位行銷團隊。我們在搜尋引擎優化和搜尋引擎廣告方面投入了資源。這確實吸引了更多患者前往 Nyxoah。這已經是我們投資的第一部分。

And then next, our DTC advertising campaign was launched in March and has raised awareness for HGNS and Genio. As a result, we have seen a rapid growth in appointment requests through our helpline. The current plan from patient identification to Genio implant or the conversion time, as it sometimes referred to in Germany is 6 to 8 months. So we anticipate beginning next quarter to see a real strong benefit.

接下來，我們的 DTC 廣告活動於 3 月啟動，提高了 HGNS 和 Genio 的知名度。因此，我們發現透過我們的求助專線提出的預約請求迅速成長。目前計劃從患者識別到 Genio 植入或轉換時間（在德國有時稱為）為 6 至 8 個月。因此，我們預計從下個季度開始就會看到真正的強勁效益。

When it comes to the U.S., I think I have to start with saying that Inspire from a DTC perspective, did or has done a tremendous job establishing the HGNS market for patients, physicians and payers in the U.S. In this regard, it is sometimes nice to be #2 entering the market. We anticipate having our full sales force hired and trained by the time of launch. These reps will target both implanting ENTs and referring sleep physicians, supported by focused DTC investments. And I think that's really important. So we are planning to invest in DTC, but it will be very focused. Additionally, we are currently investing in market access to ensure CMS reimbursement is secured at launch and to expedite commercial coverage. Sorry for being a little bit long, but you had also 2 questions.

說到美國，我想我必須先說，從 DTC 的角度來看，Inspire 已經或已經在為美國的患者、醫生和付款人建立 HGNS 市場方面做出了巨大的工作。在這方面，有時很好成為進入市場的第二名。我們預計在產品發佈時，我們的全部銷售人員都會被聘用並接受培訓。這些代表將在 DTC 重點投資的支持下，針對植入耳鼻喉科醫生和轉診睡眠醫生。我認為這非常重要。所以我們計劃投資DTC，但會非常有針對性。此外，我們目前正在投資市場准入，以確保 CMS 報銷在推出時得到保障，並加快商業覆蓋。抱歉，有點長，但您還有兩個問題。

Our next question comes again from Adam Maeder with Piper Sandler.

我們的下一個問題再次來自 Adam Maeder 和 Piper Sandler。

I just wanted to follow up with another question on just reimbursement. So from a reimbursement perspective, can you remind us, one, on the coding, it sounded like last quarter that you would have a clear idea of what that code is by year-end. Is that still the case? And then two, just what is the strategy in terms of garnering payer coverage? And what kind of initiatives are you guys putting in place to kind of work up to that, so that everything is squared away or by launch?

我只是想跟進另一個關於報銷的問題。因此，從報銷的角度來看，您能否提醒我們，第一，關於編碼，聽起來就像上個季度一樣，到年底您就會清楚地了解該代碼是什麼。現在還是這樣嗎？第二個問題，獲得付款人覆蓋的策略是什麼？你們正在採取什麼樣的措施來完成這項工作，以便一切都安排妥當或透過啟動？

Yes. So last month, at the AAO meeting in Nashville, an advisory panel for the ENT scientific society discussed the CPT code that would best support Genio. And to your point, this is one of the scenarios that I was mentioning earlier that has now been put more forward. So multiple CPT codes were evaluated. And while I cannot yet disclose the complete outcome of the discussion, we expect reimbursement will be at minimum in line with the current HGNS payment rates. So that is already, I think, the first answer.

是的。因此，上個月，在納許維爾舉行的 AAO 會議上，ENT 科學協會的一個顧問小組討論了最能支持 Genio 的 CPT 代碼。就你而言，這是我之前提到的場景之一，現在已經被更多地提出。因此評估了多個 CPT 代碼。雖然我還不能透露討論的完整結果，但我們預計報銷將至少與當前的 HGNS 支付率一致。我認為這已經是第一個答案了。

Next, I have to again say that competition has done a terrific job educating the commercial payers about the benefit of HGNS, resulting in all having HGNS coverage policies. We have already engaged in informal discussions with payers and expect to be able to leverage those policies. At launch, we anticipate being reimbursed through prior authorizations and we would expect to be included in coverage policies within 12 months afterwards. Now very complete from a market access perspective, we have the team in place that is working to secure reimbursement from both CMS and the commercial payers. That team will also work with customers through the prior authorization process when we launched in the U.S.

接下來，我必須再次指出，競爭在教育商業付款人了解 HGNS 的好處方面發揮了出色的作用，導致所有人都擁有 HGNS 承保政策。我們已經與付款人進行了非正式討論，並希望能夠利用這些政策。在推出時，我們預計會透過事先授權獲得報銷，並預計在之後 12 個月內被納入承保保單中。現在從市場准入的角度來看已經非常完善，我們的團隊正在努力確保 CMS 和商業付款人的報銷。當我們在美國推出產品時，該團隊也將透過事先授權流程與客戶合作。

Our next question comes from Suraj Kalia from Oppenheimer & Company.

我們的下一個問題來自 Oppenheimer & Company 的 Suraj Kalia。

This is Shaymus on for Suraj. So I believe earlier you said that you had submitted the third module to the FDA. Have you received any questions on the submission so far? Any feedback yet that you can share with us?

這是 Shaymus 替補 Suraj。所以我相信您之前說過您已向 FDA 提交了第三個模組。到目前為止，您收到過任何有關提交的問題嗎？您還有什麼回饋可以與我們分享嗎？

So the short answer is yes. We did receive some deficiency questions on module 1 and 2. We answered them, and they will also be submitted shortly. So just to summarize, and as a reminder, there are 4 modules in total, the first module was more quality overview on preclinical data. We submitted. We got some questions, nothing that is worrying us in the sense that we do feel extremely confident, and we also have answered all these questions.

所以簡短的回答是肯定的。我們確實收到了一些關於模組1和2的缺陷問題。我們已經回答了它們，它們也將很快提交。總結一下，提醒一下，總共有 4 個模組，第一個模組是對臨床前數據的更多品質概述。我們提交了。我們收到了一些問題，但沒有什麼讓我們擔心的，因為我們確實感到非常有信心，而且我們也回答了所有這些問題。

Second module, same thing, remaining preclinical data. Also there, we got, I think, I can say the normal or the expected questions that we are answering and then now with third module, it's more on manufacturing and the manufacturing validation. So it was submitted a week ago.

第二個模組，同樣的事情，剩餘的臨床前數據。另外，我想，我可以說我們正在回答的正常或預期的問題，然後現在有了第三個模組，更多的是關於製造和製造驗證。所以一週前就提交了。

Now the last one, and that's why it got really exciting. So module 4, it will be the final module and that is the one we can submit with, including clinical data review and IFU labeling, and we expect to do this somewhere end of March, beginning April after we had the time to analyze the data that we will have in the first week of March of the DREAM study.

現在是最後一個，這就是為什麼它變得非常令人興奮。因此，模組 4，這將是最後一個模組，也是我們可以提交的模組，包括臨床數據審查和 IFU 標籤，我們預計在 3 月底、4 月開始的某個時間我們有時間分析數據後進行此操作我們將在3 月的DREAM 研究的第一週進行。

Got it. Looking at Germany and kind of the competition there, there's some overlap, I know you've discussed it before between you and a competitor. So in those sites, what's the driving factor for those accounts saying I'm going to implant a patient with Genio versus one of your competitors' systems.

知道了。看看德國和那裡的競爭，有一些重疊，我知道你之前和競爭對手之間已經討論過這個問題。因此，在這些網站中，那些帳號說我要給病人植入 Genio 的驅動因素是什麼，而不是競爭對手的系統。

So first, I would like to point out that in quarter 3, we are still estimating that our market share stays in the range of 20% market share during the quarter. I think this is first really important point, because as you know, since we entered the German market 2 years ago, with having also CPT codes, we were able to immediately capture 20% to 25% market share, and this has been continuing always being in this range with a strong Q4, where we were slightly above 30%. So that is already the first part to your question.

首先，我想指出，在第三季度，我們仍然估計我們的市佔率在該季度的市佔率保持在20%的範圍內。我認為這是第一個非常重要的一點，因為正如你所知，自從我們兩年前進入德國市場以來，憑藉CPT代碼，我們能夠立即佔領20％至25％的市場份額，並且這種情況一直在持續在此範圍內，第四季表現強勁，略高於 30%。這已經是你問題的第一部分。

So if you look at implant sites, that we are going after as a fast follower in sites where Inspire already was several years active. We see that in those sites or in all sites, we are able to take market share in a significant way. That's number one. Point two, what we are seeing is when you go to higher volume side, we also saw that in the top 5, we were able to take more market share than the 20%. So there was even stronger uptake in some top implanting sites in Germany.

因此，如果您查看植入站點，我們將作為 Inspire 已經活躍多年的站點的快速追隨者進行追隨。我們看到，在這些網站或所有網站中，我們能夠以顯著的方式佔據市場份額。這是第一名。第二點，我們看到的是，當你進入更高的交易量方面時，我們也看到，在前 5 名中，我們能夠佔據比 20% 更多的市場份額。因此，德國一些頂級植入地點的使用率甚至更高。

Now I think when you have competition entering and there is a monopolistic market, you also can increase overall HGNS penetration. And I'm really pleased to see that we are driving this because that is something that we are hearing back from surgeons as well. First, we are extremely pleased that there is not an option to choose between 2 therapies. Second, by having this option, they're also seeing that more patients are being treated with one of those two (inaudible) an increased therapy penetration. And I keep repeating, and I have to come back to the uniqueness of our system that a single incision, a CCC indication, a full body MRI compatibility and also a real patient-centric approach is really something that is speaking very positively to physicians and patients.

現在我認為，當競爭進入並且存在壟斷市場時，您也可以提高 HGNS 的整體滲透率。我真的很高興看到我們正在推動這一進程，因為我們也從外科醫生那裡得到了回饋。首先，我們非常高興沒有在兩種療法之間進行選擇。其次，透過這種選擇，他們也看到更多的患者正在接受這兩種療法之一（聽不清楚）的治療，從而提高了治療的滲透率。我不斷重複，我必須回到我們系統的獨特性，即單一切口、CCC 適應症、全身 MRI 相容性以及真正以患者為中心的方法確實對醫生和患者來說非常積極。患者。

(inaudible) to the next quarter, we are looking forward to beginning 2024 also in Europe commercially to see the impact of the investment, and of course, to also further expand into new and other countries. And to that point, I'm sorry that I keep going. But to that point, we also have some good news coming from the U.K., where we are now officially allowed to participate in an NHS standard. So that will also definitely help us accelerating revenue in Europe coming from more countries than mainly Germany.

（聽不清楚）到下個季度，我們期待從 2024 年開始在歐洲進行商業投資，以看到投資的影響，當然，還會進一步擴展到新的國家和其他國家。到那時，我很抱歉我繼續前進。但到目前為止，我們也從英國傳來了一些好消息，英國現在正式允許我們參與 NHS 標準。因此，這也肯定會幫助我們加速歐洲的收入，這些收入來自更多國家，而主要是德國。

Got it. I appreciate all the color there. And if I can sneak one more in. Just kind of looking when you do the U.S. launch. I know it's a little ways away, but I know you said about 100 to 150 reps. How many sites are you looking to initially launch at, how many centers? Just trying to tie the color of centers to reps, so to speak.

知道了。我欣賞那裡的所有顏色。如果我能再偷偷溜進去一次。當你在美國發射時看看。我知道這還有點距離，但我知道你說的是 100 到 150 次。您最初希望在多少個網站、多少個中心推出？可以這麼說，只是想將中心的顏色與代表連結起來。

So although I would really love to answer your question, I think you can understand that I do not want to be going too concrete to that question for the simple reason that '24 will be the year where based on successful DREAM data, we will have FDA approval later at the end of the year and hopefully also start commercializing. Currently, we are looking at a couple of scenarios. One scenario is where we would go, of course, with a kind of focused launch and try to go immediately after, let's say, roughly half of the Inspire side that we have today. On the other hand, it's also not a secret when you look at productivity for a sales rep, whether it now is with Nyxoah or with another new modulation company, we would be aiming to have EUR 1 million of sales by sales up.

因此，雖然我真的很想回答你的問題，但我想你可以理解，我不想對這個問題說得太具體，原因很簡單，24 年將是基於成功的 DREAM 數據的一年，我們將擁有FDA 將於今年底批准，並有望開始商業化。目前，我們正在研究幾種場景。當然，一種情況是我們會進行集中發布，並嘗試立即發布，比方說，我們今天擁有的大約一半的 Inspire 版本。另一方面，當您考慮銷售代表的生產力時，這也不是秘密，無論是現在在 Nyxoah 還是在另一家新的調製公司，我們的目標是實現 100 萬歐元的銷售額增長。

Our next question comes from David Rescott with Baird.

我們的下一個問題來自 David Rescott 和 Baird。

I wanted to start off on the partnership that you announced a couple weeks ago, I'm curious. I know it's -- I mean it seems like it's something that could be pretty exciting. I know it's a couple of weeks or so into it since the announcement. I'm just curious if you're at a point yet where things are kind of established and maybe you're starting to see some patients start to either roll in specifically to Nyxoah, maybe through the partnership at all? Or if there's anything you anecdotally -- that you can provide just around how that maybe already is starting to impact the business? Or maybe if it's a couple of more quarters still before the potential benefits from that partnership could be realized.

我想從您幾週前宣布的合作夥伴關係開始，我很好奇。我知道這——我的意思是，這似乎是一件非常令人興奮的事情。我知道自宣布以來已經過去了幾週左右的時間。我只是好奇你是否已經到了事情已經確定的地步，也許你開始看到一些患者開始專門加入 Nyxoah，也許是透過合作夥伴關係？或者，如果您有什麼軼事，您可以提供一些可能已經開始影響業務的資訊嗎？或者，也許還需要幾個季度才能實現這種夥伴關係的潛在收益。

Yes. So first, since it's really (inaudible), I think it's difficult to exactly predict when we will see what kind of impact. But what I would like to come back to, and I think this is something where I also would like to give a lot of credit to the ResMed colleagues in Germany. It is really putting a patient at the centers. Really further looking beyond CPAP, hypoglossal nerve stimulation, mandibular device treatment.

是的。首先，由於它確實（聽不清楚），我認為很難準確預測我們何時會看到什麼樣的影響。但我想回過頭來，我認為這也是我要對德國瑞思邁同事給予高度讚揚的地方。這確實是把病人放在中心。真正進一步超越 CPAP、舌下神經刺激、下顎裝置治療。

Now what is exactly and precisely the best solution for patients suffering from OSA. And therefore, I keep repeating, CPAP is the golden standard. It was excellent, but the issue is that a lot of patients simply quit their CPAP after a period of time. Now if these patients are suffering from moderate-to-severe OSA, it is so important to offer them a treatment. We all know the cardiovascular risk that is associated, the risk of strokes, the cost for healthcare systems, if you do not treat patients suffering from moderate-to-severe OSA. So I'm really proud, on one hand that we can say that, together with ResMed in Germany, we are really looking at what is best for the patient.

現在對於患有 OSA 的患者來說，到底什麼才是最好的解決方案？因此，我不斷重複，CPAP 是黃金標準。這很好，但問題是許多患者在一段時間後就放棄了 CPAP。現在，如果這些患者患有中度至重度 OSA，為他們提供治療就非常重要。我們都知道，如果不治療中度至重度 OSA 患者，就會產生相關的心血管風險、中風風險以及醫療保健系統的成本。因此，我真的很自豪，一方面，我們可以說，我們與德國瑞思邁一起，真正在尋找對患者最有利的方法。

Now that being said, it's also clear that we need to, first of all, stores then get used to each other a little bit. that is ongoing. Sales teams are talking with each other, marketing teams of talking with each other. We are looking at DTC initiatives. We have the first major congress coming up in Berlin, where we both will be present and interacting with several KOLs. And I think a realistic approach would be that you would see the first impact in overall patient penetration increase and Genio specific increase as of Q1 next year.

話雖這麼說，但很明顯，我們首先需要讓商店相互適應。這是持續進行的。銷售團隊互相交談，行銷團隊互相交談。我們正在研究 DTC 舉措。我們將在柏林召開第一屆大型大會，我們都將出席並與幾位 KOL 互動。我認為一個現實的方法是，從明年第一季開始，您將看到整體患者滲透率增加和 Genio 特定增加的第一個影響。

Okay. Great. That's helpful. And just on ACCESS in the U.S. I'm wondering the level of visibility maybe you have into that trial, I know that with kind of complete concentric collapse patient population there, maybe a higher concern around those patients having higher BMIs and maybe there being a bigger impact from GLP-1s. So just wondering what level of visibility you have into that and whether or not you have a better informed view maybe on what the potential impact could be either into that specific patient population or just broadly across all nerve stimulators?

好的。偉大的。這很有幫助。就在美國的 ACCESS 上，我想知道您對該試驗的了解程度，我知道那裡的患者群體完全同心塌陷，也許對那些 BMI 較高的患者有更高的關注，也許有GLP-1 的影響更大。因此，只是想知道您對此的了解程度如何，以及您是否對特定患者群體或所有神經刺激器的潛在影響有更深入的了解？

Yes. So let me start with, first with some facts. So in the ACCESS study, that protocol (inaudible) up to 40 sites that were implanted, although we do not anticipate activating that many, we have so far activated 4 sites, but we can go up to 40. That's that one. Second fact is that we are feeling comfortable that we will close the enrollment by the end of 2024. Everything is going in this direction. So it's trending really in a positive way.

是的。讓我先介紹一些事實。因此，在ACCESS 研究中，該協議（聽不清楚）最多植入了40 個位點，儘管我們預計不會激活那麼多點，但到目前為止我們已經激活了4 個位點，但我們最多可以植入40 個位點。就是這樣。第二個事實是，我們對將於 2024 年底結束招生感到放心。一切都在朝這個方向發展。所以它的趨勢確實是正面的。

Now another fact is that in the ACCCESS study of BMI -- the patient's BMI cannot be above 35. I think this is important, as I already was commenting earlier, we believe, and we see this in clinical literature that to have an optimal therapeutic effect from HGNS, a patient should not be having a BMI that is higher than 35. What we also learned in this that patients suffering from CCC and also the correlation with their BMI is present. So we see that we have a lot of patients with the BMI somewhere in the range of 30 to 35.

現在另一個事實是，在BMI 的ACCCESS 研究中，患者的BMI 不能高於35。我認為這很重要，正如我之前已經評論過的那樣，我們相信，並且我們在臨床文獻中看到這一點，即有一個最佳的治療方案根據 HGNS 的影響，患者的 BMI 不應高於 35。我們也從中了解到，患有 CCC 的患者及其與 BMI 的相關性是存在的。所以我們看到很多患者的 BMI 在 30 到 35 之間。

Now what you can expect is that there are also quite some patients with a BMI above 35 that are suffering from CCC. And that is precisely where we are seeing a very positive impact from GLP-1s because -- and if you speak to KOLs, what we did extensively, we're also hearing there, but it's clear that lower the BMI that is above 35, bring the patient in the range of 30 to 35 implant with HGNS and have a successful therapeutic response. Physicians are more behind that concept than increasing of implanting patients with a BMI above 35. And where there is a risk that there will be not a strong therapeutic response.

現在可以預見的是，也有相當一部分BMI超過35的患者患有CCC。這正是我們看到GLP-1 帶來的非常積極影響的地方，因為——如果你與KOL 交談，我們廣泛做了什麼，我們也聽到了那裡的情況，但很明顯，降低35 以上的BMI ，為患者植入 30 至 35 個 HGNS 植入物並獲得成功的治療反應。醫生們更支持這個概念，而不是增加 BMI 高於 35 的患者的植入量。而且存在著不會產生強烈治療反應的風險。

So I'm welcoming mostly the GLP-1 impact too low and to bring those really obese patients into this range below 35%. And then regardless, if they suffer from CCC or non-CCC, with Genio, we know that we can offer them a successful therapeutic solution.

因此，我主要歡迎 GLP-1 的影響太低，並將那些真正肥胖的患者納入低於 35% 的範圍。無論他們患有 CCC 還是非 CCC，我們都知道，透過 Genio，我們可以為他們提供成功的治療解決方案。

Our next question comes from Ross Osborn with Cantor Fitzgerald.

我們的下一個問題來自羅斯·奧斯本和坎托·菲茨杰拉德。

In terms of commercialization activities outside of Germany, would you provide an update on how Spain is receiving your system following first implants this summer? Additionally, I would be curious to hear what other countries you had implants in during the quarter, in addition to Italy? And where we should be thinking about for the balance of this year and 2024?

就德國以外的商業化活動而言，您能否提供有關今年夏天首次植入後西班牙如何接收您的系統的最新資訊？此外，我很想知道除了義大利之外，本季你們還在哪些國家進行了植入？對於今年和 2024 年的剩餘時間，我們應該考慮哪些問題？

Yes. So to your point, so today, we are reimbursed in Spain, in Switzerland and also, of course, in Germany, where we generate like 95% of our revenue. And going forward, we did first Italy, because in Italy, in order to obtain reimbursement, there was a demand for country-specific data, and that's why we did the first patients already. We are going up to 10 patients in Italy. And then based on these data, we will submit them together with the existing data. And hopefully, this will result also in a reimbursement in Italy.

是的。因此，就您的觀點而言，今天，我們在西班牙、瑞士，當然還有德國獲得了報銷，我們的收入約佔 95%。展望未來，我們首先在義大利進行了治療，因為在義大利，為了獲得報銷，需要特定國家的數據，這就是為什麼我們已經對第一批患者進行了治療。我們將在義大利治療最多 10 名患者。然後根據這些數據，我們會將它們與現有數據一起提交。希望這也能在義大利得到補償。

In the Nordic countries, same thing goes for Finland. So there we did some implants already. And based on these data, we are trying to secure hospital reimbursement hospital by hospital, and also we generate more commercial implants in Finland. And what I was mentioning earlier on, I think a very important market will be the U.K. First step to enter the U.K. is to being allowed by NHS to participate in a tender. We have received this official communication that we are. Now the next steps will be how to compete in this tender and how to make our case strong, so we can enter. So that's in a nutshell where we are and where you can expect us to be reimbursed shortly.

在北歐國家，芬蘭也是如此。所以我們已經做了一些植入。根據這些數據，我們正在努力確保逐家醫院獲得醫院報銷，並且我們也在芬蘭生產更多的商業植入物。我之前提到的，我認為一個非常重要的市場將是英國。進入英國的第一步是獲得 NHS 的允許參與招標。我們已收到此官方通訊。現在，下一步將是如何參與本次招標，以及如何使我們的案例更有說服力，以便我們能夠參與。簡而言之，這就是我們的現狀，您可以期待我們很快就會得到報銷。

Thank you very much for your questions. I am showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. Enjoy your evening. And you may now disconnect.

非常感謝您的提問。我目前沒有提出任何進一步的問題。感謝您參加今天的會議。這確實結束了該程式。享受你的夜晚。您現在可以斷開連線。

Thank you.

謝謝。