NeuroOne Medical Technologies Corp (NMTC) 2024 Q4 法說會逐字稿

Good day, ladies and gentlemen. Welcome to the NeuroOne fourth-quarter and fiscal year-end 2024 earnings 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. Chris Volker, the company's Chief Operating Officer, will also be in attendance.

美好的一天，女士們先生們。歡迎參加 NeuroOne 第四季和 2024 財政年度終收益電話會議。今天的電話會議將由公司執行長 Dave Rosa 主持；以及該公司財務長羅恩·麥克盧格(Ron McClurg)。該公司首席營運長克里斯·沃爾克也將出席。

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 date.

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 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. 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 good morning to everyone. During our fiscal fourth quarter and through today, we have continued to execute our plan and accomplished key milestones regarding commercialization, product development, and financial objectives.

謝謝接線員，大家早安。從第四財季到今天，我們繼續執行我們的計劃，並實現了商業化、產品開發和財務目標的關鍵里程碑。

In 2024, our top priorities were to pursue a 510(k) clearance from the FDA to market our OneRF ablation system and to secure a strategic partnership for distribution. While there was risk associated with the 510(k), given there were no other devices with such a clearance, we successfully achieved this objective, as well as securing a strategic partnership to distribute the system. We are proud that the OneRF ablation system is the first and only FDA-cleared system with an intended use for both reporting electrical activity and ablation of nervous tissue utilizing the same device.

2024 年，我們的首要任務是獲得 FDA 的 510(k) 許可，以行銷我們的 OneRF 消融系統並確保分銷策略合作夥伴關係。雖然 510(k) 存在相關風險，但考慮到沒有其他設備具有此類許可，我們成功實現了這一目標，並建立了戰略合作夥伴關係來分銷該系統。我們感到自豪的是，OneRF 消融系統是第一個也是唯一一個獲得 FDA 批准的系統，其預期用途是使用相同裝置報告電活動和神經組織消融。

Our recent announcement regarding the extension of the partnership with Zimmer Biomet provides a broad distribution network for both the US and certain OUS geographies. In addition, NeuroOne received an upfront license payment of $3 million and the potential to earn an additional milestone payment if certain performance criteria are achieved. We expect the expanded partnership to boost NeuroOne sales and to drive improved profitability. With that confidence, we are excited to provide guidance for fiscal year 2025 for revenue of $8million to $10 million, representing revenue growth of 132% to 190% over 2024.

我們最近宣布延長與 Zimmer Biomet 的合作關係，為美國和美國某些地區提供了廣泛的分銷網絡。此外，NeuroOne 還獲得了 300 萬美元的預付款許可，如果達到某些性能標準，則有可能獲得額外的里程碑付款。我們預計擴大的合作夥伴關係將促進 NeuroOne 的銷售並提高獲利能力。懷著這樣的信心，我們很高興能夠為 2025 財年的收入提供 800 萬至 1000 萬美元的指導，這意味著收入比 2024 年增長 132% 至 190%。

We are also projecting gross margins for fiscal year 2025 to range between 47% and 51%, compared to gross margins of 31% in 2024. We are very happy to be reporting strong annual revenue growth in fiscal 2024 and expect our revenue growth and margin improvement to accelerate in 2025. We have also been able to strengthen our balance sheet with a $3 million license payment from Zimmer Biomet, along with the improved product gross margins from the expanded Zimmer Biomet partnership, as well as the $2.65 million private placement completed in August.

我們也預期 2025 財年的毛利率將在 47% 至 51% 之間，而 2024 年的毛利率為 31%。我們很高興在 2024 財年報告強勁的年度收入成長，並預計我們的營收成長和利潤率改善將在 2025 年加速。我們還透過 Zimmer Biomet 支付的 300 萬美元許可費、擴大的 Zimmer Biomet 合作關係提高的產品毛利率以及 8 月份完成的 265 萬美元私募來增強了我們的資產負債表。

Regarding the launch of the OneRF ablation system, we have been working very closely with the Zimmer Biomet team to initiate commercialization activities, including initial product shipments and training of Zimmer Biomet personnel. Physician interest has been very strong, including during the product exhibition at the American Epilepsy Society meeting last week.

關於 OneRF 消融系統的推出，我們一直與 Zimmer Biomet 團隊密切合作，啟動商業化活動，包括初始產品出貨和 Zimmer Biomet 人員培訓。醫生的興趣非常濃厚，包括上周美國癲癇協會會議上的產品展覽。

We are also very happy to report that OneRF ablation procedures have now been completed in 12 patients, and to date, all patients are either seizure free or have had a significant reduction in seizure occurrence and less severe seizures after the OneRF ablation procedure. We continue to be overwhelmed with the initial results and have now performed more than 150 RF ablations on 12 patients in five centers during our initial limited launch. To date, 24 epilepsy centers have requested proposals to acquire the technology, which doubled from last quarter, and we continue to receive strong interest from neurosurgeons and neurologists regarding the technology.

我們也非常高興地報告，OneRF 消融手術現已在 12 名患者中完成，迄今為止，所有患者在 OneRF 消融手術後要么沒有癲癇發作，要么癲癇發作顯著減少，癲癇發作也較輕。我們仍然對最初的結果感到不知所措，在最初的有限啟動期間，我們已經對 5 個中心的 12 名患者進行了 150 多次射頻消融。迄今為止，已有 24 個癲癇中心請求獲得該技術的提案，數量比上季度增加了一倍，並且我們繼續收到神經外科醫生和神經科醫生對該技術的強烈興趣。

We are also happy to report that the new ICD-10 PCS code granted by CMS for the OneRF ablation procedure became effective October 1, 2024, and will allow hospitals to report inpatient procedures that are performed using the OneRF ablation system. This will serve to support accurate data collection and processing of reimbursement claims by hospitals for the procedure.

我們也很高興地報告，CMS 為 OneRF 消融手術授予的新 ICD-10 PCS 代碼於 2024 年 10 月 1 日生效，並將允許醫院報告使用 OneRF 消融系統執行的住院手術。這將有助於支持準確的數據收集和醫院對手術報銷申請的處理。

Turning to our product development programs, I am excited to announce that we are pursuing additional applications for RF ablation outside of the brain. Our next FDA submission will target patients with debilitating facial pain also known as trigeminal neuralgia. The trigeminal nerve is located in the face with one nerve on each side of the face.

談到我們的產品開發計劃，我很高興地宣布，我們正在尋求腦外射頻消融的其他應用。我們下一次向 FDA 提交的文件將針對患有使人衰弱的臉部疼痛（也稱為三叉神經痛）的患者。三叉神經位於臉部，臉部兩側各有一條神經。

Trigeminal neuralgia is also a chronic pain condition and is characterized by severe, sudden, and recurrent facial pain, with over 150,000 patients diagnosed each year in the United States. We expect to submit our 510(k) application to the FDA in the first half of calendar year 2025, with the potential to contribute to revenue in calendar year 2025 that is not currently factored in to our 2025 revenue plan or revenue guidance.

三叉神經痛也是一種慢性疼痛疾病，其特徵是嚴重、突發和復發性臉部疼痛，美國每年診斷出超過 15 萬名患者。我們預計在 2025 年上半年向 FDA 提交 510(k) 申請，有可能為 2025 年的收入做出貢獻，而目前尚未計入我們的 2025 年收入計劃或收入指導中。

We remain convinced that the OneRF ablation system can serve as a platform technology for additional indications such as RF ablation for lower back pain and knee pain among others. We believe that having multiple indications for a OneRF ablation system provides competitive differentiation compared to a single function system and will offer added value to hospitals and physicians, which can be a consideration in hospital purchasing decisions.

我們仍然相信，OneRF 消融系統可以作為一種平台技術，用於其他適應症，例如針對腰痛和膝蓋疼痛的射頻消融。我們相信，與單一功能係統相比，具有多種適應症的 OneRF 消融系統具有競爭優勢，並將為醫院和醫生提供附加價值，這可以成為醫院採購決策時的考慮因素。

I would also like to provide updates on our product development programs leveraging our thin electrode platform technology for spinal cord stimulation and drug delivery. With regard to our percutaneous paddle lead program for use in spinal cord stimulation, we have successfully optimized the percutaneous delivery of our paddle lead system by incorporating steerable capabilities for reliable deployment.

我還想提供有關利用我們的薄電極平台技術進行脊髓刺激和藥物輸送的產品開發計劃的最新資訊。關於我們用於脊髓刺激的經皮槳式導線計劃，我們透過整合可靠部署的可操縱功能，成功優化了槳式導線系統的經皮輸送。

Preclinical studies performed by renowned pain specialists have confirmed that our electrode can be implanted percutaneously in less than five minutes. They also noted that our percutaneous paddle electrode has the benefits of being up to 20 times thinner while providing broad therapeutic coverage similar to what is provided by traditional electrodes, but without requiring more invasive surgical implant techniques.

著名疼痛專家進行的臨床前研究證實，我們的電極可以在五分鐘內經皮植入。他們還指出，我們的經皮槳式電極的優點是厚度薄達 20 倍，同時提供與傳統電極類似的廣泛治療覆蓋範圍，但不需要更具侵入性的手術植入技術。

Based on the strong feedback from our advisory board, we initiated discussions with potential strategic partners under actively exploring partnerships for this technology. This technology is another great example of our novel thin film technology that can be applied for multiple indications, including not only back and neck pain, but also for other potential peripheral pain applications.

根據顧問委員會的強烈回饋，我們開始與潛在的策略夥伴進行討論，並積極探索該技術的合作關係。這項技術是我們新型薄膜技術的另一個很好的例子，它可以應用於多種適應症，不僅包括背部和頸部疼痛，還包括其他潛在的周邊疼痛應用。

We are also making significant progress with our sEEG-based drug delivery program, which leverages the small size and easy implantation of our commercially available sEEG devices. We are confident that we can deliver a smaller device than competitors while providing a larger internal diameter that does not require the use of real-time MRI for placement, which is very costly and time consuming.

我們基於 sEEG 的藥物輸送計劃也取得了重大進展，該計劃利用了我們市售 sEEG 設備的小尺寸和易於植入的優勢。我們有信心能夠提供比競爭對手更小的設備，同時提供更大的內徑，並且不需要使用即時 MRI 進行放置，這是非常昂貴且耗時的。

Going forward, we will be preparing a 510 application for sEEG-based drug delivery, as well as developing a miniaturized device for use in preclinical research. We believe that NeuroOne's sEEG-based drug delivery technology with multifunctionality is uniquely capable to provide physicians and researchers with neurological recording data before, during, and after directly delivering in the brain a therapeutic agent such as gene therapies, stem cell therapies, and other biopharmaceutical therapies for the treatment of neurological disorders.

展望未來，我們將準備基於 sEEG 的藥物輸送的 510 應用，並開發用於臨床前研究的小型化設備。我們相信NeuroOne 的基於sEEG 的多功能藥物傳輸技術具有獨特的能力，能夠在直接向大腦輸送治療劑（例如基因療法、幹細胞療法和其他生物製藥）之前、期間和之後為醫生和研究人員提供神經記錄數據用於治療神經系統疾病的療法。

Finally, we intend to continue actively monitoring the closing bid price for our common stock between now and January 7, 2025, and will consider all available options to resolve the deficiency and regain compliance with Nasdaq's minimum bid price requirement.

最後，我們打算從現在到 2025 年 1 月 7 日繼續積極監控普通股的收盤價，並將考慮所有可用的選項來解決缺陷並重新遵守納斯達克的最低買入價要求。

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

我現在想將電話轉給 Ron McClurg，他將回顧我們第四財季和 2024 財年的財務表現。

Thanks, Dave.

謝謝，戴夫。

Product revenue was $0.3 million in the fourth quarter of fiscal 2024, compared to $0.7 million in the prior year fourth quarter. The reduction in product revenue in the fourth quarter of fiscal 2024 was due to the company's cancellation of a Zimmer Biomet purchase order in order to transition our manufacturing to the new OneRF product line. Product revenue increased 77% to $3.5 million in fiscal year '24, compared to $2 million in fiscal year 2023. The company also had collaboration revenue of $1.5 million in fiscal 2023, which 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 fiscal year 2023.

2024 財年第四季的產品收入為 30 萬美元，而去年第四季的產品收入為 70 萬美元。2024 財年第四季產品收入減少的原因是該公司取消了 Zimmer Biomet 採購訂單，以便將我們的製造轉移到新的 OneRF 產品線。2024 財年的產品收入成長了 77%，達到 350 萬美元，而 2023 財年為 200 萬美元。該公司在 2023 財年還擁有 150 萬美元的合作收入，該收入來自 Zimmer 開發協議，代表了有資格在 2023 財年確認收入的排他性和里程碑費用付款的一部分。

Our total operating expenses decreased 12% to $3 million in the fourth quarter of fiscal year 2024, compared to $3.4 million in the prior year fourth quarter. Total operating expenses decreased 6% to $13 million in the full fiscal year 2024, compared to $13.9 million in fiscal year 2023.

2024 財年第四季度，我們的總營運支出下降了 12%，降至 300 萬美元，而上年第四季為 340 萬美元。2024 年整個財年的總營運費用下降 6%，至 1,300 萬美元，而 2023 年財年為 1,390 萬美元。

R&D expense decreased 39% to $1.1 million in the fourth quarter of fiscal '24, compared to $1.8 million in the prior year fourth quarter. R&D expense decreased by 27% to $5.1 million for the full fiscal year 2024, compared to $6.9 million in fiscal year 2023.

2024 財年第四季的研發費用下降了 39%，至 110 萬美元，而去年第四季的研發費用為 180 萬美元。2024 財年的研發費用下降了 27%，至 510 萬美元，而 2023 財年的研發費用為 690 萬美元。

Selling, general, and administrative expense, or SG&A, was $1.8 million in the fourth quarter of fiscal 2024, compared to $1.6 million in the prior year fourth quarter. SG&A expense was $7.9 million in fiscal year 2024, compared to $6.9 million for the full fiscal year 2023.

2024 財年第四季的銷售、一般和管理費用 (SG&A) 為 180 萬美元，而去年第四季為 160 萬美元。2024 財年的銷售、管理及行政費用為 790 萬美元，而 2023 財年全年為 690 萬美元。

Our net loss was $3.3 million for the fourth quarter of fiscal '24, compared to a net loss of $3.1 million in the same period -- prior year fourth quarter. Our net loss for the full fiscal year 2024 was $12.3 million, compared to a net loss of $11.9 million in fiscal 2023.

我們 2024 財年第四季的淨虧損為 330 萬美元，而去年同期（去年第四季）的淨虧損為 310 萬美元。我們 2024 財年的淨虧損為 1,230 萬美元，而 2023 財年的淨虧損為 1,190 萬美元。

In the fourth quarter of fiscal 2024, the company completed a $2.65 million private placement of its common stock and entered into a $3 million standby secured credit facility agreement.

2024財年第四季度，該公司完成了265萬美元普通股的私募，並簽訂了300萬美元的備用擔保信貸安排協議。

As of September 30, 2024, the company had cash and cash equivalents of $1.5 million, compared to $5.3 million as of September 30, 2023.

截至2024年9月30日，該公司擁有現金及現金等價物為150萬美元，而截至2023年9月30日為530萬美元。

The company had working capital of $2.4 million as of September 30, 2024, compared to working capital of $5.5 million as of September 30, 2023. The company had no debt outstanding as of September 30, 2024.

截至2024年9月30日，該公司的營運資本為240萬美元，而截至2023年9月30日，該公司的營運資本為550萬美元。截至2024年9月30日，公司無未償債務。

Following receipt of the $3 million payment from Zimmer Biomet in November of 2024, the company terminated the $3 million standby secured credit facility agreement.

2024 年 11 月收到 Zimmer Biomet 的 300 萬美元付款後，該公司終止了 300 萬美元的備用擔保信貸協議。

As Dave mentioned before, we are providing full fiscal year 2025 financial guidance. The company expects product revenue for fiscal year 2025 to range between $8 million and $10 million, representing an increase of between 132% and 190% when compared to the product revenue of $3.5 million in fiscal year 2024. The company expects product gross margin in fiscal year 2025 to range between 47% and 51%, compared to product gross margins of 31% in fiscal year 2024.

正如戴夫之前提到的，我們正在提供 2025 財年的完整財務指導。該公司預計2025財年的產品收入將在800萬至1,000萬美元之間，較2024財年的350萬美元產品收入成長132%至190%。該公司預計2025財年的產品毛利率將在47%至51%之間，而2024財年的產品毛利率為31%。

I would now like to turn the floor back to Dave Rosa for closing remarks.

現在我想請戴夫·羅莎（Dave Rosa）發表閉幕詞。

Thank you, Ron.

謝謝你，羅恩。

In closing, we are very happy with the progress made in fiscal 2024 and are looking forward to driving accelerated revenue growth and margin improvement in 2025. We now have clear near-term growth drivers, as well as a strong product pipeline leveraging our novel platform technology.

最後，我們對 2024 財年的進展感到非常滿意，並期待在 2025 年推動營收加速成長和利潤率改善。我們現在擁有明確的近期成長動力，以及利用我們新穎的平台技術的強大產品線。

In the near term, we are well positioned to drive meaningful revenue growth and margin improvement, having just completed the first shipments to Zimmer Biomet of the OneRF ablation system, the first and only FDA-cleared device for RF ablation in the brain. We also expect our trigeminal nerve indication to be commercialized potentially in calendar year 2025, and we are continuing to make progress on product development milestones and potential strategic partnerships for our drug delivery and spinal cord stimulation programs.

短期內，我們已做好充分準備，推動顯著的收入成長和利潤率提高，剛剛完成了OneRF 消融系統向Zimmer Biomet 的第一批發貨，該系統是第一個也是唯一一個獲得FDA 批准的大腦射頻消融設備。我們也預計我們的三叉神經適應症可能會在 2025 年實現商業化，並且我們將繼續在產品開發里程碑以及我們的藥物傳輸和脊髓刺激項目的潛在戰略合作夥伴關係方面取得進展。

I would like to thank everyone for attending the call and look forward to updating you on our progress next quarter.

我要感謝大家參加電話會議，並期待向您通報我們下個季度的最新進展。

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。