NeuroOne Medical Technologies Corp (NMTC) 2024 Q2 法說會逐字稿

Good day, ladies and gentlemen. Welcome to the Neuroone Medical Technologies Corporation second quarter of fiscal year 2024 financial results conference call. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa, and Ron McClurg, the company's Chief Financial Officer.

美好的一天，女士們先生們。歡迎參加 Neuroone 醫療科技公司 2024 財年第二季財務業績電話會議。今天的電話會議將由公司執行長戴夫·羅莎 (Dave Rosa) 和公司財務長 Ron McClurg 主持。

Before I turn the call over to Mr. Rosa, 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 dates.

在將電話轉交給羅莎先生之前，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陳述。層截至今天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 risk, 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. Except as required by law, Neuroone undertakes no obligation to update such forward-looking statements.

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，以了解可能導致實際結果有所不同的特定風險和不確定性的資訊。除法律要求外，Neuroone 不承擔更新此類前瞻性聲明的義務。

With that, I will turn the call over to Mr. Dave Rosa, CEO of Neuroone. Please go ahead, sir.

接下來，我會把電話轉給 Neuroone 執行長 Dave Rosa 先生。請繼續，先生。

Thanks, operator, and welcome, everyone. During the second quarter of fiscal 2024, we continued to make significant progress on our objectives relating to both commercialization and product development. First, I would like to comment on the commercial progress with our Evo sEEG electrode product line and commercialization partner, Zimmer Biomet. Zimmer continues to add new accounts and as previously discussed, we saw a corresponding increase in Evo sEEG sales and revenue.

謝謝運營商，歡迎大家。在 2024 財年第二季度，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，我想談談我們的 Evo sEEG 電極產品線和商業化合作夥伴 Zimmer Biomet 的商業進展。Zimmer 繼續增加新客戶，正如之前所討論的，我們看到 Evo sEEG 銷售額和收入相應增加。

We still believe there is a significant opportunity for continued growth as Zimmer Biomet further expands into new centers. We also expect to see improvements in our product margins as we transition the product offering from Evo sEEG diagnostic electrodes to OneRF electrodes. As a reminder, the OneRF ablation system is sthe first FDA-cleared system with an intended use for both recording electrical activity and ablation of nervous tissue utilizing the same device.

我們仍然相信，隨著 Zimmer Biomet 進一步擴展到新中心，持續成長的機會巨大。隨著我們將產品從 Evo sEEG 診斷電極過渡到 OneRF 電極，我們也期望看到產品利潤率的提高。提醒一下，OneRF 消融系統是第一個獲得 FDA 批准的系統，其預期用途是使用相同裝置記錄電活動和消融神經組織。

To date, we have implanted five patients at one center and look forward to adding new centers this quarter for a limited commercial launch. Once we receive additional ablation generators, we will expand the launch more broadly. We expect that to occur during the third calendar quarter as additional generators are delivered to the company.

迄今為止，我們已在一個中心植入了五名患者，並期待本季增加新的中心以進行有限的商業啟動。一旦我們收到額外的消融發生器，我們將更廣泛地擴大發射範圍。我們預計，隨著額外的發電機交付給公司，這將在第三季發生。

Regarding device distribution, we are currently distributing the product directly, but remain in discussions with potential strategic partners regarding the licensing of the technology. We also presented an ICD-10 PCS hospital inpatient code application to the Centers for Medicare & Medicaid Services otherwise known as CMS in March for the OneRF ablation procedure, support accurate data collection, and processing of reimbursement claims by hospitals for the procedure.

關於設備分銷，我們目前正在直接分銷產品，但仍在與潛在的策略合作夥伴就技術授權進行討論。我們也在3 月向醫療保險和醫療補助服務中心（也稱為CMS）提交了針對OneRF 消融手術的ICD-10 PCS 醫院住院患者代碼申請，支持準確的數據收集以及醫院對該手術的報銷索賠的處理。

In addition, we plan to leverage the versatility of our ablation generator by targeting other indications to treat pain. We are targeting the submission of a new application to the FDA by the end of this calendar year, and we'll provide further updates as we get closer to a submission date.

此外，我們計劃透過針對其他適應症來治療疼痛，從而利用消融發生器的多功能性。我們的目標是在本日曆年年底之前向 FDA 提交新申請，隨著提交日期的臨近，我們將提供進一步的更新。

We previously discussed our drug delivery program and the potential of our sEEG platform technology to deliver pharmacologic therapies to the brain as well as monitor the therapy's impact. We believe that technology could be helpful for drug development, clinical studies, and eventually offer another tool for neurosurgeons to treat a variety of neurosurgical complications.

我們之前討論了我們的藥物傳輸計劃以及我們的 sEEG 平台技術向大腦提供藥物治療以及監測治療效果的潛力。我們相信，該技術有助於藥物開發、臨床研究，並最終為神經外科醫生提供另一種工具來治療各種神經外科併發症。

During the past quarter, we made progress on developing and testing accessories that were requested by a potential strategic partner. The company continued to show progress in the development of electrode for use in spinal cord stimulation to treat patients suffering with low back pain. Members of our Physician Advisory Board were able to successfully place a paddle electrode in five minutes or less using our proprietary percutaneous delivery system. We expect to freeze the design of this technology by the end of this calendar year.

在過去的季度中，我們在潛在策略合作夥伴要求的配件開發和測試方面取得了進展。該公司在用於脊髓刺激以治療腰痛患者的電極開發方面繼續取得進展。我們的醫師諮詢委員會成員能夠使用我們專有的經皮輸送系統在五分鐘或更短的時間內成功放置槳式電極。我們預計在今年年底前凍結這項技術的設計。

I would now like to turn the call over to Ron McClurg to provide a review of our second quarter fiscal year 2024 financial results.

我現在想將電話轉給 Ron McClurg，請他對我們 2024 財年第二季的財務表現進行審查。

Thank you, Dave. Product revenue was $1,377,000 in the second quarter of fiscal '24 compared to product revenue of only $466,000 in the second quarter of fiscal 2023. For the first six months of fiscal '24, product revenue was $2,355,000 compared to $581,000 for the same period of fiscal 2023. The company had no collaboration revenue in the first six months of fiscal 2024 compared to collaboration revenue of $1.46 million in the first six months of fiscal 2023.

謝謝你，戴夫。24 財年第二季的產品收入為 1,377,000 美元，而 2023 財年第二季的產品收入僅為 466,000 美元。24 財年的前六個月，產品收入為 2,355,000 美元，而 2023 財年同期為 581,000 美元。該公司在 2024 財年的前六個月沒有協作收入，而 2023 財年前六個月的協作收入為 146 萬美元。

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 second quarter of fiscal 2024 were $3.3 million compared with $3.5 million in the same period of the prior fiscal year. Research and development expense in the second quarter of fiscal '24 was $1.3 million compared to $1.7 million in the second quarter of fiscal 2023.

2024 財年第二季的總營運費用為 330 萬美元，上一財年同期為 350 萬美元。24 財年第二季的研發費用為 130 萬美元，而 2023 財年第二季的研發費用為 170 萬美元。

Selling, general, and administrative expense in the second quarter of fiscal 2024 was $2 million compared with $1.8 million in the prior year period. For the first six months of fiscal '24, total operating expenses were $6.9 million compared with $6.8 million in the same period of fiscal '23.

2024 財年第二季的銷售、一般及管理費用為 200 萬美元，而去年同期為 180 萬美元。24 財年的前六個月，總營運費用為 690 萬美元，而 23 財年同期為 680 萬美元。

R&D expense in the first six months of fiscal 2024 was $2.8 million compared with $3.3 million in the same period of fiscal '23. SG&A expense in the first six months of fiscal 2024 was $4.2 million compared with $3.5 million in the prior year period.

2024 財年前六個月的研發費用為 280 萬美元，而 2023 財年同期為 330 萬美元。2024 財年前六個月的銷售、管理及行政費用為 420 萬美元，去年同期為 350 萬美元。

Net loss was $2.9 million for the second quarter of fiscal 2024 compared to a net loss of $3.5 million in the second quarter of 2023. Net loss for the first six months of fiscal '24 was $6.2 million compared with $5.3 million in the same period of fiscal 2023.

2024 財年第二季的淨虧損為 290 萬美元，而 2023 年第二季的淨虧損為 350 萬美元。24 財年前六個月的淨虧損為 620 萬美元，而 2023 財年同期的淨虧損為 530 萬美元。

During the second quarter of fiscal 2024, the company sold its common stock under the ATM program at an average price of $1.43 per share, from which the company received net proceeds of $2 million. As of March 31, 2024, the company had cash and cash equivalents of $2.4 million compared to $5.3 million as of September 30, 2023.

2024財年第二季度，該公司根據ATM計劃以每股1.43美元的平均價格出售了普通股，公司從中獲得了200萬美元的淨收益。截至2024年3月31日，該公司擁有現金和現金等價物為240萬美元，而截至2023年9月30日為530萬美元。

Company had working capital of $3.2 million as of March 31, '24 compared to working capital of $5.5 million as of September 30, 2023. Company had no debt outstanding as of March 31, 2024. Subsequent to the end of the quarter, from April 1 to May 10, 2024, the company sold additional common stock under the ATM program at an average price of $1.21 a share and receive net proceeds of $1.3 million.

截至 2024 年 3 月 31 日，公司營運資本為 320 萬美元，而截至 2023 年 9 月 30 日，營運資本為 550 萬美元。截至2024年3月31日，公司無未償債務。本季末後，即2024年4月1日至5月10日，該公司根據ATM計劃以每股1.21美元的平均價格出售了額外的普通股，並獲得了130萬美元的淨收益。

With that, I will turn it back to Dave.

這樣，我會將其轉回給戴夫。

Thanks, Ron. Operator, I think we can open up for questions now if there are any questions.

謝謝，羅恩。接線員，我想如果有任何問題我們現在就可以提問。

(Operator Instructions) There are no questions in queue at this time.

（操作員說明） 目前隊列中沒有問題。

All right. Well, I'd like to provide some closing remarks at this time. First, I'd like to thank everyone, again, for attending the call. This is the best position that Neuroone has been in since the company's inception. Our revenues are growing and we are adding to the current product lines to allow for faster revenue growth and improved margins.

好的。好吧，我現在想發表一些結束語。首先，我要再次感謝大家參加這次電話會議。這是Neuroone自公司成立以來所處的最佳位置。我們的收入正在成長，我們正在增加現有的產品線，以實現更快的收入成長並提高利潤率。

In addition, we have other near-term product revenue opportunities with the devices in development, which will assist in helping us to get to breakeven status faster. We have excellent partnerships with the Mayo Clinic and Zimmer Biomet and have prominent institutional investors supporting us. I firmly believe the best is yet to come. Operator?

此外，我們還透過正在開發的設備獲得其他近期產品收入機會，這將有助於我們更快地實現收支平衡。我們與 Mayo Clinic 和 Zimmer Biomet 建立了良好的合作夥伴關係，並擁有知名機構投資者的支持。我堅信最好的尚未到來。操作員？

Thank you. Ladies and gentlemen, this does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.

謝謝。女士們先生們，今天的電話會議到此結束。此時您可以斷開電話線並度過美好的一天。感謝您的參與。