NeuroOne Medical Technologies Corp (NMTC) 2024 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the NeuroOne Medical Technologies Corporation first-quarter of fiscal year 2024 financial results conference call. Today's call will be conducted by the company's Chief Financial Officer, Ron McClurg.

女士們、先生們，美好的一天，歡迎參加 NeuroOne 醫療技術公司 2024 財年第一季財務業績電話會議。今天的電話會議將由公司財務長 Ron McClurg 主持。

Before I turn the call over to Mr. McClurg, I'd like to remind you that this conference call will include forward-looking statements within the meaning of US federal securities laws with respect to future operations, financial results, events, trends, and performance, which are based on management's beliefs and assumptions as of today's call or other specified date.

在將電話轉交給麥克盧格先生之前，我想提醒您，本次電話會議將包括美國聯邦證券法含義內的有關未來運營、財務業績、事件、趨勢和未來運營的前瞻性聲明。管理層截至今天的電話會議或其他指定日期的信念和假設。

Forward-looking statements may involve known and unknown risks, uncertainties, and other factors which may cause actual results to differ materially from those expressed or implied by such statements. See NeuroOne's financial results press release and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ.

前瞻性陳述可能涉及已知和未知的風險、不確定性和其他因素，這些因素可能導致實際結果與此類陳述明示或暗示的結果有重大差異。請參閱 NeuroOne 的財務表現新聞稿和 SEC 文件，以了解有關可能導致實際結果不同的特定風險和不確定性的資訊。

Except as required by law, NeuroOne undertakes no obligation to update such forward-looking statements. With that, I will turn the call over to Mr. Ron McClurg, CFO of NeuroOne. Please go ahead, sir.

除法律要求外，NeuroOne 不承擔更新此類前瞻性聲明的義務。接下來，我會將電話轉給 NeuroOne 財務長 Ron McClurg 先生。請繼續，先生。

Thank you, operator. Before I begin, I wanted to mention that Dave Rosa, our CEO, had minor surgery which prevented them from being able to present this afternoon, so I will be handling the call.

謝謝你，接線生。在開始之前，我想提一下，我們的執行長戴夫·羅莎（Dave Rosa）做了小手術，導致他們無法在今天下午出席會議，所以我將接聽電話。

During the first quarter of fiscal 2024, we continued to make significant progress on our objectives relating to commercialization and product development. First, I would like to remind the audience of our recent milestone achievement of receiving FDA clearance for our OneRF Ablation System, the first FDA-cleared system with an intended use for both recording electrical activity and ablation of nervous tissue utilizing the same device.

在 2024 財年第一季度，我們持續在商業化和產品開發相關目標方面取得重大進展。首先，我想提醒觀眾，我們最近取得了里程碑式的成就，我們的 OneRF 消融系統獲得 FDA 批准，這是第一個 FDA 批准的系統，其預期用途是使用同一設備記錄電活動和消融神經組織。

As previously noted, we submitted a 510(k) application to the FDA in June 2023 for the OneRF Ablation System. And we received that 510(k) clearance from the FDA in December of 2023 for the creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures. We are very excited to be the first to market this novel technology in the United States and are preparing to initiate a limited commercial launch in the second quarter of calendar 2024.

如前所述，我們於 2023 年 6 月向 FDA 提交了 OneRF 消融系統的 510(k) 申請。我們於 2023 年 12 月獲得了 FDA 的 510(k) 許可，可以在神經組織中產生射頻損傷，用於功能性神經外科手術。我們非常高興成為第一個在美國推廣這項新技術的公司，並準備在 2024 年第二季啟動有限的商業發布。

We will remain in discussions with potential strategic partners regarding the licensing of the technology for brain ablation procedures, and we expect to reach a decision in the near future regarding our commercialization strategy. We also remain open to commercializing the device directly if we believe it represents the best option for the company.

我們將繼續與潛在的策略夥伴就腦消融手術技術的許可進行討論，我們預計在不久的將來就我們的商業化策略做出決定。如果我們認為該設備代表了公司的最佳選擇，我們也對直接將該設備商業化持開放態度。

And we are working in parallel on a plan to launch the technology directly. In addition, our team is exploring other applications for the OneRF system to treat pain. We believe that there are additional market opportunities for the OneRF system that we may be able to address, and we will provide further updates in the future.

我們正在同時制定一項直接推出該技術的計劃。此外，我們的團隊正在探索 OneRF 系統治療疼痛的其他應用。我們相信 OneRF 系統還有其他市場機會，我們可能能夠解決這些問題，並且我們將在未來提供進一步的更新。

I would now like to provide an update regarding the expanded launch of our Evo sEEG electrode product line with our commercialization partner, Zimmer Biomet. Zimmer continued to strategically open new centers during our first fiscal quarter.

我現在想提供有關與我們的商業化合作夥伴 Zimmer Biomet 擴大推出 Evo sEEG 電極產品線的最新資訊。Zimmer 在第一財季繼續策略性地開設新中心。

Customer feedback remains positive regarding device performance, and we are seeing usage picking up in recent months. We completed full sales force training for Zimmer in January 2024, and we expect to see an increase in Evo sEEG sales and revenue as the launch expands. We believe the launch of the OneRF system will also have a positive impact on customer demand for the Evo sEEG electrode product line.

客戶對設備性能的回饋仍然積極，我們看到近幾個月的使用量增加。我們於 2024 年 1 月完成了 Zimmer 的全面銷售人員培訓，我們預計隨著推出範圍的擴大，Evo sEEG 的銷售額和收入將會增加。我們相信OneRF系統的推出也將對客戶對Evo sEEG電極產品線的需求產生正面影響。

Moving on to our drug delivery program, we have discussed the potential for our SEEG electrode technology to deliver drugs or gene therapies to the brain, as well as record the therapy's impact. During the past quarter, we completed feasibility benchtop testing and an animal study, demonstrating the ability to deliver a therapy, and provide recording capabilities using the sEEG drug delivery system.

繼續我們的藥物傳輸計劃，我們討論了 SEEG 電極技術向大腦輸送藥物或基因療法以及記錄治療效果的潛力。在過去的季度中，我們完成了可行性台式測試和動物研究，展示了提供治療的能力，並使用 sEEG 藥物輸送系統提供記錄功能。

We are currently in contract discussions with a biotech company regarding their interest in using our device in upcoming clinical studies and have had discussions with other potential partners. We are excited with the prospects of this technology, and how it may assist the biopharma industry in their drug or gene therapy delivery development, and also its value clinically in current neurosurgical procedures.

我們目前正在與一家生物技術公司就他們有興趣在即將進行的臨床研究中使用我們的設備進行合約討論，並與其他潛在合作夥伴進行了討論。我們對這項技術的前景感到興奮，以及它如何幫助生物製藥行業進行藥物或基因療法的開發，以及它在當前神經外科手術中的臨床價值。

If we are able to reach an agreement in our current contract negotiations, the technology has the potential to add revenue later in calendar year 2024.

如果我們能夠在目前的合約談判中達成協議，該技術有可能在 2024 年稍後增加收入。

Development efforts with our spinal cord stimulation program to treat chronic back pain continued in our first quarter as members of our Physician Advisory Board successfully placed a nine millimeter paddle electrode utilizing a percutaneous placement approach in a cadaver model.

第一季度，我們繼續致力於治療慢性背痛的脊髓刺激計劃的開發工作，我們的醫師顧問委員會成員利用經皮放置方法成功在屍體模型中放置了 9 毫米槳式電極。

Paddle electrodes are similar in concept to cortical or film electrodes. In addition, we completed a preclinical study of the first acute electrophysiology experiment with NeuroOne's lead in a sheep model. Spinal cord stimulation and pain management remain a priority given the size of the market opportunity and the potential competitive advantages of our technology.

槳式電極在概念上與皮質或薄膜電極相似。此外，我們也以 NeuroOne 為主導，在綿羊模型中完成了首次急性電生理實驗的臨床前研究。考慮到市場機會的規模和我們技術的潛在競爭優勢，脊髓刺激和疼痛管理仍然是優先考慮的事項。

I would now like to provide a review of our first quarter fiscal year 2024 financial results. Product revenue was $978,000 in the first quarter of fiscal 2024 compared to product revenue of $115,000 in the first quarter of fiscal 2023. The company had no collaboration revenue in the first quarter of fiscal '24 compared to collaboration revenue of $1,455,000 in the first quarter of fiscal 2023.

我現在想回顧一下我們 2024 財年第一季的財務表現。2024 財年第一季的產品收入為 978,000 美元，而 2023 財年第一季的產品收入為 115,000 美元。該公司在 2024 財年第一季沒有協作收入，而 2023 財年第一季的協作收入為 1,455,000 美元。

Collaboration revenue in 2023 was derived from the Zimmer development agreement and represents the portion of the exclusivity and milestone fee payments that were eligible for revenue recognition during the period.

2023 年的合作收入來自 Zimmer 開發協議，代表該期間有資格確認收入的排他性和里程碑費用付款的部分。

Total operating expenses in the first quarter of fiscal 2024 were $3.7 million compared to $3.2 million in the first quarter of fiscal 2023. R&D expense in the first quarter of fiscal '24 was $1.5 million compared with $1.6 million in the same period of fiscal 2023.

2024 財年第一季的總營運支出為 370 萬美元，而 2023 財年第一季的總營運支出為 320 萬美元。2024 財年第一季的研發費用為 150 萬美元，而 2023 財年同期為 160 萬美元。

SG&A expense in the first quarter of fiscal '24 was $2.2 million compared to $1.7 million in the first quarter of fiscal 2023. The net loss was $3.3 million for the first quarter of fiscal 2024 compared to a net loss of $1.7 million in the first quarter of fiscal 2023. In December of 2023, the company sold common stock under the ATM offering at an average price of $1.45 per share, and received net proceeds of $1.2 million.

2024 財年第一季的 SG&A 費用為 220 萬美元，而 2023 財年第一季的 SG&A 費用為 170 萬美元。2024 財年第一季的淨虧損為 330 萬美元，而 2023 財年第一季的淨虧損為 170 萬美元。2023年12月，該公司以每股1.45美元的平均價格出售了ATM發行的普通股，並獲得了120萬美元的淨收益。

As of December 31, 2023, the company had cash, cash equivalents, and short-term investments of $2.7 million compared to $5.3 million as of September 30, 2023, our previous fiscal year end. The company had working capital of $3.7 million as of December 31, 2023, compared to working capital of $5.5 million as of September 30, 2023. The company had no debt outstanding as of December 31, 2023.

截至2023 年12 月31 日，該公司擁有現金、現金等價物和短期投資270 萬美元，而截至2023 年9 月30 日（即我們上一財年末）的現金、現金等價物和短期投資為530 萬美元。截至2023年12月31日，該公司的營運資本為370萬美元，而截至2023年9月30日的營運資本為550萬美元。截至2023年12月31日，本公司無未償還債務。

Subsequent to the end of the first quarter, in January of 2024, the company sold additional common stock under the ATM offering at an average price of $1.46 per share and received net proceeds of $1.54 million.

第一季末後的 2024 年 1 月，該公司在 ATM 發行中以每股 1.46 美元的平均價格出售了額外的普通股，並獲得了 154 萬美元的淨收益。

Operator, at this time, I think we can open up for questions.

接線員，這時候我想我們可以開放提問了。

Absolutely. Thank you. At this time, we will be conducting a question-and-answer session. (Operator Instructions)

絕對地。謝謝。此時，我們將進行問答環節。（操作員說明）

Our first question comes from Alex Nowak with Craig-Hallum. Please proceed.

我們的第一個問題來自亞歷克斯·諾瓦克和克雷格·哈勒姆。請繼續。

Yes, good afternoon. This is Conner on for Alex. Thanks for taking my questions. Could you maybe speak on the RF generator parts? I know last quarter you mentioned that was one of the holdouts in getting some of these systems placed. Any update on that would be great.

是的，下午好。這是康納為亞歷克斯發言。感謝您回答我的問題。您能談談射頻產生器零件嗎？我知道上個季度您提到這是部署其中一些系統的阻力之一。任何關於這方面的更新都會很棒。

One of the -- I think what we may have mentioned in the past was that -- there were some long lead time components and that was the gating factor for us in terms of when we could launch a limited release of the device. And we've got those components on order. We are expecting to receive our first units of the hardware, the RF generator itself, by the end of March. And so we are looking at beginning a very limited launch of the product in the second calendar quarter of this year.

其中之一 - 我想我們過去可能提到的是 - 有一些交貨時間較長的組件，這對於我們何時可以推出該設備的有限版本而言是一個限制因素。我們已經訂購了這些組件。我們預計在三月底收到第一批硬件，即射頻發生器本身。因此，我們計劃在今年第二季開始非常有限地推出該產品。

Got you. And then maybe can you speak on any initial impact on Evo sEEG sales following the OneRF approval? I know you mentioned a step up, and then maybe when can we start seeing Zimmer to fully start launching Evo? Or is there any barriers preventing this full launch?

明白你了。那麼您能否談談 OneRF 批准後對 Evo sEEG 銷售的初步影響？我知道你提到了一個步驟，那麼也許我們什麼時候可以開始看到 Zimmer 全面開始推出 Evo？或有任何障礙阻礙全面啟動？

There are no barriers at this time that are preventing the full launch, other than and when we initiated the limited launch, we only trained a portion of their sales force. So as I mentioned during the call, in January, so just last month, we attended their national sales meeting and trained their full distribution network, including distributors and direct employees.

目前沒有任何障礙阻止全面推出，除了當我們啟動有限推出時，我們只培訓了他們的部分銷售人員。正如我在電話中提到的，在一月份，就在上個月，我們參加了他們的全國銷售會議，並培訓了他們的整個分銷網絡，包括分銷商和直接員工。

And one of the things that is kind of gating the rollout is their -- approval by the value analysis committees at each of the hospitals. So that is underway right now. They've got a targeted launch. They're trying to do this in a methodical manner and continue to add new accounts as we go forward.

限制推出的因素之一是每家醫院價值分析委員會的批准。所以現在正在進行中。他們有一個有針對性的發射。他們正在嘗試有條不紊地做到這一點，並隨著我們的進展繼續添加新帳戶。

Great. And then one more here. Could you speak towards the progress on maybe a potential partnership? Could this be within the year time span, less or more? I know you mentioned direct as well.

偉大的。然後這裡還有一個。您能否談談潛在合作夥伴關係的進展？這可能是在一年的時間跨度內，或更短還是更長？我知道你也直接提過。

Well, we are we are in discussions right now with a couple of potential strategic partners. And if those come to fruition, we will then distribute the OneRF Ablation System through that distributor.

嗯，我們現在正在與幾個潛在的策略夥伴進行討論。如果這些實現，我們將透過該經銷商分銷 OneRF 消融系統。

If we do not get terms that are favorable or acceptable for the company, we are prepared to go and start distribution on our own. And that's what I meant when I said we are kind of -- we have a dual path right now that we are operating under so that we don't delay, regardless of which direction we go.

如果我們沒有獲得對公司有利或可接受的條款，我們準備自行開始分銷。這就是我說的意思——我們現在有一條雙重路徑，這樣我們就不會拖延，無論我們朝哪個方向走。

Thanks for taking my questions.

感謝您回答我的問題。

We do want to make that decision before we proceed with the limited launch. So we should have that decision made here in the near term.

我們確實希望在進行有限發布之前做出決定。所以我們應該在短期內做出這個決定。

Got you. Great. Thank you.

明白你了。偉大的。謝謝。

Thank you, Conner.

謝謝你，康納。

Okay, we have no further questions in the queue. I will now turn the call back over to management for any closing remarks.

好的，我們隊列中沒有其他問題了。我現在將把電話轉回給管理層，讓他們發表結束語。

Yes, thank you, operator. I would just like to say that the company is making great progress toward our goals for fiscal 2024. We're excited by the FDA clearance of the OneRF Ablation System, and pleased with the expansion of Zimmer Biomet's launch of the Evo sEEG electrode, and the related increase in revenue. We continue to make progress on our drug delivery program, and our spinal cord stimulation program intended to treat chronic back pain.

是的，謝謝你，接線生。我只想說，公司正在朝著 2024 財年的目標取得巨大進展。我們對 OneRF 消融系統獲得 FDA 批准感到興奮，並對 Zimmer Biomet 擴大 Evo sEEG 電極的推出以及相關收入的成長感到高興。我們繼續在藥物傳遞計畫和旨在治療慢性背痛的脊髓刺激計畫上取得進展。

Altogether, we believe NeuroOne has the potential to add revenue in 2024 beyond just sEEG sales. With contributions coming from the OneRF commercial launch and potential drug delivery partnerships. We hope you will continue to follow our exciting progress. Thank you.

總而言之，我們相信 NeuroOne 有潛力在 2024 年增加 sEEG 銷售額之外的收入。OneRF 商業發布和潛在的藥物輸送合作夥伴關係做出了貢獻。我們希望您繼續關注我們令人興奮的進展。謝謝。

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.

今天的會議到此結束，此時您可以掛斷電話了。感謝您的參與。