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Operator
Operator
Good day and welcome to the Brainsway fourth-quarter and full-year 2024 earnings conference call. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to Brian Ritchie of LifeSci Advisors. Please go ahead.
大家好,歡迎參加 Brainsway 2024 年第四季和全年財報電話會議。(操作員指示)請注意,此事件正在被記錄。現在我想將會議交給 LifeSci Advisors 的 Brian Ritchie。請繼續。
Brian Ritchie - Investor Relations
Brian Ritchie - Investor Relations
Thank you, all, and welcome to Brainsway's fourth-quarter and full-year 2024 earnings conference call. With us today are Brainsway's Chief Executive Officer, Hadar Levy, and Chief Financial Officer, Ido Marom.
謝謝大家,歡迎參加 Brainsway 2024 年第四季和全年財報電話會議。今天與我們在一起的有 Brainsway 的執行長 Hadar Levy 和財務長 Ido Marom。
The format for today's call will be a discussion of recent trends and business updates from Hadar, followed by a detailed discussion of the financials. Then we will open up the call for your questions.
今天電話會議的形式是討論 Hadar 的最新趨勢和業務更新,然後詳細討論財務狀況。然後我們將開始回答您的問題。
Earlier today, Brainsway released financial results for the three months and full year ended December 31, 2024. A copy of the press release is available on the company's Investor Relations website.
今天早些時候,Brainsway 發布了截至 2024 年 12 月 31 日的三個月和全年財務業績。新聞稿副本可在公司投資者關係網站上查閱。
Before I turn the call over to Hadar, I would like to remind you that this conference call, including both management's prepared remarks and the question-and-answer session, may contain projections or other forward-looking statements regarding, among other topics, Brainsway's anticipated future operating and financial performance, business plans and prospects, and expectations for its products and pipeline; which are all subject to risks and uncertainties, including shifting market conditions resulting from geopolitical supply chain, and other factors, as well as the use of non-GAAP financial information.
在我將電話轉給哈達爾之前,我想提醒您,本次電話會議(包括管理層的準備好的發言和問答環節)可能包含有關 Brainsway 預期的未來運營和財務業績、業務計劃和前景以及對其產品和渠道的期望等主題的預測或其他前瞻性陳述;這些都受風險和不確定性的影響,包括地緣信息供應鏈導致財務供應鏈導致的非會計準則和其他會計因素,以及公認的政治供應鏈導致財務供應鏈導致的政治條件變化。
Additional information regarding these and other risks are available in the company's earnings release and in its other filings with the SEC, including the risk factor section contained in Brainsway's Form 20-F. I would now like to turn the call over to Hadar. Please go ahead, Hadar.
有關這些風險和其他風險的更多信息,請參閱公司的收益報告和向美國證券交易委員會提交的其他文件,包括 Brainsway 的 20-F 表格中包含的風險因素部分。現在我想把電話轉給哈達爾。請繼續,哈達爾。
Hadar Levy - Chief Executive Officer
Hadar Levy - Chief Executive Officer
Thank you, Brian. Welcome, everyone, and thank you for joining us today. We are excited to announce today that we completed 2024 with another quarter of rapidly growing sales of our market leading Deep TMS system. The steady rise in our performance reflects the successful execution of our strategy focused on building sales momentum and scale up our commercial distribution around the world.
謝謝你,布萊恩。歡迎大家,感謝你們今天的到來。今天,我們很高興地宣布,我們市場領先的 Deep TMS 系統的銷售額在 2024 年又實現了一個季度的快速成長。我們業績的穩定成長反映了我們成功執行了專注於建立銷售動能和擴大全球商業分銷的策略。
As you will see, these results further reinforce Brainsway's true business and technological leadership position in the TMS field. On the top line, we generated $11.4 million in revenue, marking a 27% year-over-year increase.
正如您將看到的,這些結果進一步鞏固了 Brainsway 在 TMS 領域真正的業務和技術領導地位。我們的營業收入為 1,140 萬美元,年增 27%。
Our multi-year agreement with large enterprise networks strengthened customer partnership beyond one-time sales, ensuring alignment with their evolving needs. Additionally, our lease-based business model option continues to expand our return revenue base, providing a more stable foundation for long-term growth.
我們與大型企業網路簽訂的多年協議加強了客戶合作夥伴關係,超越了一次性銷售,確保滿足他們不斷變化的需求。此外,我們基於租賃的業務模式選擇繼續擴大我們的回報收入基礎,為長期成長提供更穩定的基礎。
In the fourth quarter of 2024, we shipped a total of 75 Deep TMS systems, representing a 25% increase compared with the same period last year. I think it is worth noting that, combined with our growing backlog and record revenues, we have established a positive book-to-build ratio over the past several quarters.
2024年第四季,我們共出貨75套Deep TMS系統,較去年同期成長25%。我認為值得注意的是,結合我們不斷增長的積壓訂單和創紀錄的收入,我們在過去幾個季度中建立了積極的訂單建造比。
This underscores the exceptional execution of our commercial team as we continue to partner with larger enterprise customers, those that have consistently delivered the highest return on ourselves and marketing investment. We have significantly expanded our market presence, making Deep TMS accessible to more customers than ever before.
這凸顯了我們商業團隊的卓越執行力,我們將繼續與大型企業客戶合作,這些客戶始終如一地為我們自己和行銷投資帶來最高的回報。我們大幅擴大了我們的市場佔有率,使比以往更多的客戶能夠使用 Deep TMS。
To support this growth, we optimize our sales force to accelerate expansion within larger institutional and enterprise accounts in the US and internationally. Our global reach now extends across key markets, including Canada, Asia, India, and Europe.
為了支持這一成長,我們優化了銷售隊伍,以加速美國和國際上更大的機構和企業帳戶的擴張。我們的全球業務範圍現已擴展至加拿大、亞洲、印度和歐洲等主要市場。
As we successfully transition into this new phase of growth, we are driving increased profitability, further setting us apart in our industry. This is reflected in our strong growth margin, which was 75% in the fourth quarter and for the full year. We generated positive quarterly net income for the fifth consecutive quarter and positive adjusted EBITDA and cash flow from operation for the sixth consecutive quarter.
隨著我們成功過渡到這一新的成長階段,我們正在提高獲利能力,進一步在產業中脫穎而出。這反映在我們強勁的成長利潤率上,第四季和全年的成長利潤率均達到 75%。我們連續第五個季度實現正季淨收入,連續第六個季度實現正調整後 EBITDA 和經營現金流。
Looking ahead, we are introducing full year 2025 revenue in the range of $49 million to $51 million. This would represent a growth of 20% to 24% over 2024. We also anticipate generating operating income of 3% to 4% and adjusted EBITDA of 11% and 12% for the full-year 2025.
展望未來,我們預計 2025 年全年營收將在 4,900 萬美元至 5,100 萬美元之間。這意味著到 2024 年將成長 20% 至 24%。我們也預期 2025 年全年營業收入將成長 3% 至 4%,調整後 EBITDA 將成長 11% 至 12%。
We aim to further solidify our market leadership by leveraging our strong sales momentum and executing key strategic investment across three core areas. Advancing our next generation Deep TMS 360 system, conducting clinical trials to expand and enhance treatment capabilities, and strengthening our commercial presence through targeted sales and marketing initiatives.
我們旨在利用強勁的銷售動能並在三個核心領域進行關鍵策略投資,進一步鞏固我們的市場領導地位。推進我們的下一代 Deep TMS 360 系統,開展臨床試驗以擴大和增強治療能力,並透過有針對性的銷售和行銷計劃加強我們的商業影響力。
Our primary objectives are to drive market awareness, execute on our R&D roadmap, and expand access to Deep TMS. We believe that these are critical as we work to further cement our role in shaping the future of mental health treatment.
我們的主要目標是提高市場知名度、執行我們的研發路線圖並擴大對 Deep TMS 的訪問。我們相信,這些對於我們進一步鞏固我們在塑造心理健康治療未來中的作用至關重要。
On the commercial front, we expect to see increased sales around OCD in 2025, as our system is the first TMS therapy approved for obsessive compulsive disorder. OCD is a difficult-to-treat-disease with limited treatment options, a substantial potential market of roughly 400,000 patients annually who are resistant to current treatment options. As a reminder, our most recent data for this indication are very positive, with over 60% of patients responding to Deep TMS treatment.
在商業方面,我們預計 2025 年強迫症相關的銷售額將會成長,因為我們的系統是第一個獲準用於治療強迫症的 TMS 療法。強迫症是一種難以治療的疾病,治療選擇有限,每年約有 40 萬名對現有治療方案有抵抗力的患者,這是一個巨大的潛在市場。提醒一下,我們針對此適應症的最新數據非常積極,超過 60% 的患者對深部 TMS 治療有反應。
Turning to depression, doctors have been reporting an increase in anxious depression Deep TMS treatment in the US. As a reminder, this refers to the patients with major depressive disorder who also exhibit comorbid and anxiety symptoms.
談到憂鬱症,醫生報告稱,美國焦慮憂鬱症深部經顱磁刺激治療的病例增加。提醒一下,這指的是患有重度憂鬱症並同時表現出共病和焦慮症狀的患者。
This is a large addressable medical need that affects approximately 10 million to 60 million adults in the US each year. As a reminder, our system was the first TMS device cleared by the FDA to effectively treat this condition.
這是一個巨大的可解決的醫療需求,每年影響美國約 1000 萬至 6000 萬成年人。提醒一下,我們的系統是第一個獲得 FDA 批准可有效治療這種疾病的 TMS 裝置。
We have also seen an increase in utilization of Deep TMS to treat elderly patients with MDD in the second half of 2024. This structure in the market follows the US FDA's groundbreaking decision to raise the upper age limit from 68 to 86 years old for the indication in June 2024.
我們也看到,到 2024 年下半年,使用深部經顱磁刺激 (Deep TMS) 治療患有 MDD 的老年患者的使用率將會增加。市場出現這種結構是在美國 FDA 做出開創性決定之後做出的,該決定將於 2024 年 6 月將適應症的年齡上限從 68 歲提高到 86 歲。
As life expectancies continue to rise, many are looking for innovative therapeutic solutions to alleviate the significant burden this condition places on our aging population. This clearance made our system the first and only TMS device approved to treat elderly patients with MDD.
隨著預期壽命不斷增加,許多人都在尋找創新的治療方案,以減輕這種疾病對老齡化人口帶來的巨大負擔。此次批准使我們的系統成為第一個也是唯一一個獲準用於治療患有 MDD 的老年患者的 TMS 設備。
We are also working on collecting data on Deep TMS for potential treatment for adolescent depression patients. And we will update you all to the extent we make progress on this front as well.
我們也致力於收集有關深部經顱磁刺激 (Deep TMS) 的數據,以便為青少年憂鬱症患者提供潛在的治療。我們也會向大家通報我們在這方面所取得的進展。
In September, we announced that the Israeli Ministry of Defence Rehabilitation Department granted approval for the reimbursement of Deep TMS therapy for qualifying patients at Israeli public hospitals with post-traumatic stress disorder or PTSD. We will continue working to expand the available reimbursement for PTSD in Israel with the goal of potentially including more Israeli medical centers, as well as adding private clinic settings.
9 月,我們宣布以色列國防部復健部門批准為以色列公立醫院符合條件的創傷後壓力症候群 (PTSD) 患者報銷深部 TMS 治療費用。我們將繼續努力擴大以色列對創傷後壓力症候群的報銷範圍,目標是可能涵蓋更多的以色列醫療中心,以及增加私人診所。
Another recent development on the research front was the recent publication in the Journal of Psychiatric Research showing that Deep TMS therapy, combined with psychedelic therapies, was significantly more effective in reducing depression levels among adult patients compared with standard medication alone. We believe this promising data supports additional research into the potential benefits of treating depression with a combination of Deep TMS and psychedelic therapies.
研究領域的另一項最新進展是最近在《精神病學研究雜誌》上發表的文章,該文章表明深部經顱磁刺激療法與迷幻療法相結合,與單獨使用標準藥物相比,在降低成年患者的抑鬱水平方面更為有效。我們相信,這些有希望的數據支持進一步研究使用深部經顱磁刺激和迷幻療法相結合治療憂鬱症的潛在益處。
Importantly, we continue to make progress in our randomized multi-center US clinical trial, evaluating an accelerated treatment protocol for the Deep TMS system for MDD treatment as compared to the current standard-of-care Deep TMS protocol. As a reminder, the traditional Deep TMS protocol involves a four-week acute treatment phase with one session on each day of the treatment.
重要的是,我們在美國隨機多中心臨床試驗中繼續取得進展,評估了用於治療 MDD 的深部 TMS 系統加速治療方案與目前標準治療深部 TMS 方案的比較。提醒一下,傳統的深部經顱磁刺激 (Deep TMS) 方案包括四周的急性治療階段,治療期間每天進行一次療程。
This is now being compared to an accelerated protocol, which involves a significantly shorter acute phase taking place over several treatment days. This has the potential to improve convenience and thereby make Deep TMS substantially more appealing to many prospective patients.
目前,人們正在將其與加速方案進行比較,該方案涉及在幾天的治療時間內顯著縮短的急性期。這有可能提高便利性,使深部經顱磁刺激對許多潛在患者更具吸引力。
To treat alcohol use disorder or AUD, we recently announced positive pilot data from a small independent third-party study conducted at Stanford University, evaluating an accelerated protocol using our Deep TMS technology to treat alcohol addiction patients, which was reported in a publication in the Brain Stimulation Journal. We believe these promising preliminary results will pave the way for further research into the potential benefit of treating AUD and other addiction with Deep TMS using an accelerated protocol.
為了治療酒精使用障礙或 AUD,我們最近公佈了史丹佛大學進行的一項小型獨立第三方研究的積極試點數據,該研究評估了使用我們的深部 TMS 技術治療酒精成癮患者的加速方案,該研究已在《腦刺激雜誌》的一篇出版物中進行了報道。我們相信,這些有希望的初步結果將為進一步研究使用加速協議透過深部經顱磁刺激治療 AUD 和其他成癮的潛在益處鋪平道路。
This critical investment in our long-term R&D and clinical vision are supported by a strong balance sheet with no debt. At December 31, 2024, we reported $69.4 million in cash. This includes approximately $20 million in gross proceeds received to date from our equity financing successfully completed with value equity partners. This financing will be used to support the key action items I just discussed, which are aimed at expanding our commercial footprint and supporting broader access for patients to Deep TMS.
我們對於長期研發和臨床願景的這項關鍵投資得到了強勁且無債務的資產負債表的支持。截至 2024 年 12 月 31 日,我們報告的現金為 6,940 萬美元。其中包括迄今為止我們與價值股權合作夥伴成功完成的股權融資所獲得的約 2,000 萬美元的總收益。這筆融資將用於支持我剛才討論的關鍵行動項目,旨在擴大我們的商業足跡並支持患者更廣泛地獲得深部經顱磁刺激 (Deep TMS)。
Obviously, the most important aspect of our growth strategy centers around our innovative Deep TMS system and the large enterprise customers we are focused on servicing. As a growing segment of our customer base, these enterprise accounts have been a major driver behind the larger and repeat order for Deep TMS systems over the past year.
顯然,我們成長策略最重要的方面圍繞著我們創新的Deep TMS系統和我們專注於服務的大型企業客戶。作為我們客戶群中不斷增長的一部分,這些企業帳戶是過去一年來 Deep TMS 系統訂單增加和重複的主要推動力。
In addition, by elevating our customer base, we have seen new doors open to additional enterprise customers of the same size and caliber, if not larger. With the opportunity to achieve additional large and repeat orders from both new and existing enterprise customers, we see additional meaningful room to grow in the years to come.
此外,透過擴大我們的客戶群,我們向更多同等規模和水準(甚至更大)的企業客戶敞開了新的大門。透過有機會從新舊企業客戶那裡獲得更多大額訂單和重複訂單,我們看到未來幾年還有更多有意義的成長空間。
In closing, our team is executing our strategy on several fronts. As a result, we now stand as the clear leader in TMS therapy, uniquely positioned to expand mental health access while delivering shareholder value through transformative therapies, innovation, operational excellence, and sustainable growth.
最後,我們的團隊正在多個方面執行我們的策略。因此,我們現在成為 TMS 治療領域的絕對領導者,擁有獨特的優勢,可以擴大心理健康服務範圍,同時透過轉化療法、創新、卓越營運和永續成長為股東創造價值。
With that, I will now turn the call over to Ido for his review of our fourth-quarter and full-year 2024 financial results. Ido.
現在,我將把電話交給 Ido,讓他審查我們 2024 年第四季和全年的財務表現。我願意。
Ido Marom - Chief Financial Officer
Ido Marom - Chief Financial Officer
Thank you, Hadar. Revenue for the fourth quarter of 2024 was $11.4 million a 27% increase compared to the prior year period revenue of $9 million. We placed 75 net Deep TMS systems in the fourth quarter. Our total installed base was 1,353 systems as of December 31, 2024, compared to 1,101 systems at the same point in the prior year.
謝謝你,哈達爾。2024 年第四季的營收為 1,140 萬美元,與去年同期的 900 萬美元營收相比成長 27%。我們在第四季安裝了 75 個淨 Deep TMS 系統。截至 2024 年 12 月 31 日,我們的總安裝基數為 1,353 個系統,而去年同期為 1,101 個系統。
As a result of our strong performance in the fourth quarter, we hit the top end of our guidance with $41 million of revenue recorded for the full year 2024. This represents a 29% increase compared to the $31.8 million reported for 2023.
由於我們第四季的強勁表現,我們達到了預期的最高點,2024 年全年的營收達到 4,100 萬美元。與 2023 年報告的 3,180 萬美元相比,這一數字增長了 29%。
Gross profit for the fourth quarter of 2024 was $8.5 million or a 75% growth margin. This is compared to $6.7 million during the prior year period at the same gross margin. Gross profits for the full year 2024 was $30.6 million or a 75% growth margin. This is compared to $23.5 million or a 74% growth margin during 2023.
2024 年第四季毛利為 850 萬美元,成長率為 75%。相比之下,去年同期的毛利率為 670 萬美元。2024 年全年毛利為 3,060 萬美元,成長率為 75%。相較之下,2023 年的成長幅度為 2,350 萬美元,成長率為 74%。
Moving on to operating expenses. For the fourth quarter of 2024, sales and marketing expenses were $4.5 million compared to $4 million for the fourth quarter of 2023. For full year 2024, sales and marketing expenses were $16.2 million compared to $16.5 million for 2023.
繼續討論營運費用。2024 年第四季的銷售和行銷費用為 450 萬美元,而 2023 年第四季為 400 萬美元。2024 年全年銷售和行銷費用為 1,620 萬美元,而 2023 年為 1,650 萬美元。
Research and development expenses were $2 million compared to $1.4 million in the fourth quarter of 2023. R&D expenses for the full year 2024 were $7.2 million compared to $6.7 million in 2023.
研發費用為 200 萬美元,而 2023 年第四季為 140 萬美元。2024 年全年研發費用為 720 萬美元,而 2023 年為 670 萬美元。
General and administrative expenses for the fourth quarter of 2024 were $1.6 million compared to $1.2 million for the fourth quarter of 2023. General and administrative expenses for the 12 months ended December 31, 2024, were $5.8 million compared to $5.3 million for 2023.
2024 年第四季的一般及行政費用為 160 萬美元,而 2023 年第四季為 120 萬美元。截至 2024 年 12 月 31 日的 12 個月的一般及行政費用為 580 萬美元,而 2023 年為 530 萬美元。
Operating profit for the fourth quarter was approximately $430,000 compared to approximately $180,000 for the same period in 2023. Operating profit for the full year 2024 was approximately $1.4 million compared to an operating loss of $5 million for 2023.
第四季營業利潤約為 43 萬美元,而 2023 年同期約為 18 萬美元。2024 年全年營業利潤約 140 萬美元,而 2023 年營業虧損為 500 萬美元。
Adjusted EBITDA was $1.4 million, representing the sixth consecutive quarter of positive adjusted EBITDA compared to approximately $750,000 for the fourth quarter of 2023. For the full year 2024, we reported adjusted EBITDA of $4.5 million, which is also at the top end of our guidance, representing 11% of revenue. This is compared to an adjusted EBITDA loss of $2.4 million for 2023.
調整後 EBITDA 為 140 萬美元,連續第六個季度實現正調整後 EBITDA,而 2023 年第四季約為 75 萬美元。就 2024 年全年而言,我們報告的調整後 EBITDA 為 450 萬美元,這也達到了我們預期的最高水準,佔收入的 11%。相較之下,2023 年調整後的 EBITDA 虧損為 240 萬美元。
For the fourth quarter ended December 31, 2024, we recorded net income of $1.5 million including $1 million due to a positive impact from the evaluation of warrants issued to the lower equity partners, compared to $127,000 in the same period of 2023. For the full year 2024 we recorded net income of approximately $2.9 million compared to a net loss of $4.2 million in 2023.
截至 2024 年 12 月 31 日的第四季度,我們錄得淨收入 150 萬美元,其中包括向較低股權合夥人發行的認股權證評估產生的正面影響,而 2023 年同期為 127,000 美元。2024 年全年我們的淨收入約為 290 萬美元,而 2023 年的淨虧損為 420 萬美元。
We ended the year with cash and cash equivalents, and short-term deposits of $69.4 million on December 31, 2024, which includes the $20 million in gross proceeds received to date from the private equity investment by Valor Equity Partners announced this past September.
截至 2024 年 12 月 31 日,我們的現金、現金等價物和短期存款為 6,940 萬美元,其中包括 Valor Equity Partners 於去年 9 月宣布的私募股權投資迄今獲得的 2,000 萬美元總收益。
As I mentioned earlier, based on our backlog in US pipeline and continued momentum internationally, we expect revenue in the range of $49 million to $51 million for full year 2025, which represents 20% to 24% growth over 2024 revenue. In addition, we anticipate reporting operating income of 3% to 4% of revenue and adjusted EBITDA of 11% to 12% for the full year 2025.
正如我之前提到的,基於我們在美國管道中的積壓訂單以及國際上的持續發展勢頭,我們預計 2025 年全年收入將在 4900 萬美元至 5100 萬美元之間,比 2024 年收入增長 20% 至 24%。此外,我們預計 2025 年全年營業收入將佔營收的 3% 至 4%,調整後 EBITDA 將佔 11% 至 12%。
This concludes our prepared remarks, I will now ask the operator to please open up the call for questions. Operator.
我們的準備好的演講到此結束,現在我請接線生開始提問。操作員。
Operator
Operator
(Operator Instructions) Steven Lichtman, Oppenheimer.
(操作員指示)史蒂文·利希特曼,奧本海默。
Steven Lichtman - Analyst
Steven Lichtman - Analyst
Congratulations on the quarter and year. The 75 placements was certainly a standout. Were there particular drivers this quarter that stood out that you'd like to highlight whether the enterprise network sales, international acceleration. So any further color on some of the drivers in the quarter.
恭喜本季和今年的成績。75 個名額無疑是非常突出的。本季是否有特別突出的驅動因素,您想強調的是企業網路銷售、國際加速嗎?那麼,您能否進一步了解本季的一些驅動因素?
Hadar Levy - Chief Executive Officer
Hadar Levy - Chief Executive Officer
As always, the fourth quarter is always the strongest quarter for the company. However, we do see some specific trends that I expect to continue also in 2025. Obviously, the main driver is the all the enterprise accounts that are contributing significantly to our future sales. Very high demand is coming from those enterprise accounts.
與往常一樣,第四季度始終是該公司表現最強勁的季度。然而,我們確實看到了一些特定的趨勢,我預計這些趨勢在 2025 年仍將持續下去。顯然,主要驅動力是所有對我們未來銷售做出重大貢獻的企業帳戶。這些企業帳戶的需求非常高。
The other two aspects of it are the increase use and demand for the OCD, which is also the [eight, seven] calls. We see a constant growing demand for this important indication.
它的另外兩個面向是強迫症的使用和需求的增加,這也是[八、七]的呼喚。我們看到對這一重要適應症的需求不斷增長。
And I also mentioned, I think the last thing that is important also to add is the increasing utilization in our devices both from the need for MDD, anxious depression, and also treating elderly patients. All of those together are managed to increase the demand in the fourth quarter.
我還提到,我認為最後一點也很重要,那就是我們的設備的利用率越來越高,既滿足了對 MDD、焦慮憂鬱症的需求,也滿足了治療老年患者的需求。所有這些因素共同作用,增加了第四季的需求。
Steven Lichtman - Analyst
Steven Lichtman - Analyst
Great. You mentioned progress on the accelerated treatment protocol. What's the latest in terms of timing there when we could see data?
偉大的。您提到了加速治療方案的進展。我們什麼時候能看到數據?
Hadar Levy - Chief Executive Officer
Hadar Levy - Chief Executive Officer
Yeah, so we're on the final stage of the recruitment for this very, very important indication. Our intention is to finish the follow up period, which is around 30 days, and then start analyzing the data and submit it to the FDA. I do expect to come up with some news about this indication in the third quarter of 2025.
是的,我們正處於這非常非常重要的適應症的招募的最後階段。我們的目的是完成大約 30 天的追蹤期,然後開始分析數據並將其提交給 FDA。我確實希望在 2025 年第三季推出一些有關此跡象的消息。
Steven Lichtman - Analyst
Steven Lichtman - Analyst
Got it. And then just last thing then I'll jump back in queue, on margin in 2025, can you talk to what you anticipate for gross margin this year? Thank you.
知道了。最後,我再回到隊列中,關於 2025 年的利潤率,您能談談您對今年毛利率的預期嗎?謝謝。
Hadar Levy - Chief Executive Officer
Hadar Levy - Chief Executive Officer
Yeah, so we do expect the gross margin to keep the gross margin on the same level as 2024 around 75%. I'm always saying there is more room for improvement on the gross margin, and we are taking the necessary step to try and improve it, but we are expecting the gross margin for 2025 to stay on the same level as 2024, around 75%. And same -- and also to keep the same profitability levels also on the bottom line and the EBITDA.
是的,所以我們確實預計毛利率將保持與 2024 年相同的水平,約為 75%。我一直在說毛利率還有很大的提升空間,我們也在採取必要的措施來努力提高毛利率,但我們預計 2025 年的毛利率將與 2024 年保持在同一水平,約為 75%。同樣 — — 也保持相同的盈利水平,包括底線盈利和 EBITDA。
Steven Lichtman - Analyst
Steven Lichtman - Analyst
Great. Thanks, Hadar.
偉大的。謝謝,哈達爾。
Operator
Operator
Jeffrey S. Cohen, Ladenburg Thalmann.
傑弗裡·S·科恩(Jeffrey S. Cohen),拉登堡·塔爾曼(Ladenburg Thalmann)。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Just a couple on there and I wonder if you could talk about the psychedelics at current centers and newly placed centers. Are you seeing that current centers have an increasing level of psychedelic therapy as far as percentage and what are you seeing also with new placements as far as centers out there?
這裡只有幾個問題,我想知道您是否可以談談現有中心和新建中心的迷幻藥。您是否發現目前的中心迷幻療法的水平正在不斷提高,並且您還發現中心的新佈局情況如何?
Hadar Levy - Chief Executive Officer
Hadar Levy - Chief Executive Officer
What we are seeing is more and more psychedelic clinics are open and are looking to embed the Deep TMS technology in their facilities. The main reason for that is that they already got a designated room. They got the staff, and most of them are shooting for interventional psychiatry therapy. So some of them want to try a combination of those two treatments.
我們看到越來越多的迷幻診所開業並希望在其設施中嵌入深部經顱磁刺激技術。主要原因是他們已經有指定的房間了。他們招募了工作人員,其中大多數人正在接受介入性精神病治療。因此,有些人想嘗試將這兩種治療方法結合起來。
But there is definitely a big demand from those centers from what I'm seeing in the market. What will be the impact going forward, I think it's hard to tell, but there is definitely a room for us to grow through this channel. I see all those centers potentially offering our Deep TMS technology going forward.
但從我所看到的市場情況來看,這些中心的需求肯定很大。我覺得很難說未來會產生什麼影響,但透過這個管道我們一定還有成長的空間。我認為所有這些中心都有可能在未來提供我們的 Deep TMS 技術。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Okay. Got it. And could you talk about MDD a little bit? Are you seeing any changes on the treatment paradigm with the payers out there in the marketplace for MDD and also perhaps for OCD?
好的。知道了。能簡單談談 MDD 嗎?您是否看到市場上針對 MDD 和 OCD 的付款人的治療模式發生了任何變化?
Hadar Levy - Chief Executive Officer
Hadar Levy - Chief Executive Officer
I would say that the paradigm for MDD was very positive in the last few years. They reduced the number of failures that are eligible for treatment from four failures in the past to only one or two. I do see some constant increase in some of the fees procedure, so I think that the paradigm has been positive, and I think it will stay positive as far as I see it, because at the end of the day, this is a very effective treatment that is saving money for the purse.
我想說,過去幾年 MDD 的典範非常正面。他們將符合治療條件的失敗案例數量從過去的四次減少到僅一次或兩次。我確實看到一些費用程序不斷增加,所以我認為這種模式是積極的,而且我認為它會一直保持積極狀態,因為歸根結底,這是一種非常有效的治療方法,可以為錢包省錢。
As for OCD, we also see a very steady and slow growth on the coverage by our peers. Today we've got coverage for close to 100 people's lives in the US. We need to do some more work with continue and increase this also for the OCD because that's the only available effective treatment by TMS for those patients, and I'm expecting the peers to continue and embrace this technology and to cover it in the near future.
至於強迫症,我們也看到同行的報導非常穩定且緩慢的成長。今天,我們已為美國近 100 人的生活提供了保障。我們需要做更多的工作來繼續並增加對強迫症的治療,因為這是 TMS 對這些患者唯一有效的治療方法,我希望同行能夠繼續接受這項技術並在不久的將來覆蓋它。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Got it. And then lastly for us, Hadar, could you talk about the 360 system and perhaps give us a sense of during 2025 what we may expect to hear about as far as any studies or indication or any regulatory pathways?
知道了。最後,哈達爾,您能否談談 360 系統,並讓我們了解一下 2025 年我們可能會聽到哪些研究、跡像或監管途徑?
Hadar Levy - Chief Executive Officer
Hadar Levy - Chief Executive Officer
Yeah, so I think the most exciting thing for us on the clinical side with the NextGen, the TMS 360, is to launch the multi-center trial in the US with this specific 360 system. We believe it represents the future of the TMS segment. And so the first use with this device on a multi-center trial in the US will be done through this multi-center trial that we plan to launch on the second half of 2025.
是的,所以我認為對我們來說,NextGen(TMS 360)在臨床方面最令人興奮的事情是利用這個特定的 360 系統在美國進行多中心試驗。我們相信它代表了 TMS 領域的未來。因此,我們計劃在 2025 年下半年啟動這項多中心試驗,首次在美國使用該設備。
On the same time, we do aiming also to use and to launch some feasibility studies with the TMS 360 for Alzheimer's disease and Parkinson's because we believe that this unbreaking technology could be benefit for these two indications, but we need to start to do some small feasibility studies with this technology.
同時,我們也計劃使用 TMS 360 治療阿茲海默症和帕金森氏症並進行一些可行性研究,因為我們相信這項突破性技術可能對這兩種疾病有益,但我們需要開始對這項技術進行一些小規模的可行性研究。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Okay, and when you talk about a back half launch of a multi-center trial, are you referring to MDD specifically as the indication?
好的,當您談到多中心試驗的後半段啟動時,您是指具體以 MDD 作為指徵嗎?
Hadar Levy - Chief Executive Officer
Hadar Levy - Chief Executive Officer
No, I'm referring for the AUD clinical trial on the second half of 2025.
不,我指的是 2025 年下半年的 AUD 臨床試驗。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Got it. Okay. Perfect. Thank you very much for taking our questions.
知道了。好的。完美的。非常感謝您回答我們的問題。
Operator
Operator
Carl Byrnes, Northland Capital Markets.
卡爾‧伯恩斯 (Carl Byrnes),北國資本市場 (Northland Capital Markets)。
Carl Byrnes - Analyst
Carl Byrnes - Analyst
Thanks for the question and congratulations on the quarter. I'm just wondering, given the cash bill that you have, do you see any opportunities for complimentary acquisitions or anything that might be in the business development space that we should be looking for potentially in the next 12 to 18 months or less? Thanks.
感謝您的提問,並祝賀本季取得佳績。我只是想知道,考慮到您擁有的現金帳單,您是否看到了任何補充收購的機會,或者我們應該在未來 12 到 18 個月或更短的時間內尋找的業務發展領域中的任何機會?謝謝。
Hadar Levy - Chief Executive Officer
Hadar Levy - Chief Executive Officer
Yes, we do have a very stable situation with our balance sheet, but I think that 2025 is going to be a pivotal year for the company, mostly on the innovative side. We're going to do lots of interesting and compelling studies in 2025.
是的,我們的資產負債表確實非常穩定,但我認為 2025 年將是公司的關鍵一年,主要是在創新方面。2025 年我們將進行大量有趣且引人注目的研究。
But we also looking to continue and build our future, and start planting all the right seeds for a long-term growth for the company, which means to continue and strengthen our relationship and partnership with growing and profitable enterprise accounts.
但我們也希望繼續建立我們的未來,並開始為公司的長期發展播下所有正確的種子,這意味著繼續加強我們與不斷增長且盈利的企業帳戶的關係和夥伴關係。
And so our intention is to grow organically. But also looking for some interesting collaboration and partnership with growing mental health, and potentially also addiction centers, that can really increase our backlog for the long run.
因此我們的目標是有機成長。但我們也希望與不斷發展的心理健康機構以及潛在的成癮中心建立一些有趣的合作關係,從長遠來看,這可以真正增加我們的積壓工作。
In terms of acquisition, we are not actively looking for an acquisition on the horizon. We are always looking on some interesting technologies that could be a completing technology to the Deep TMS system in the clinic. But we're also developing some new technologies that we believe could help us to bring new product to the market.
在收購方面,我們並沒有積極尋求未來的收購。我們一直在尋找一些有趣的技術,這些技術可以成為臨床中深部經顱磁刺激系統的補充技術。但我們也在開發一些新技術,我們相信這些技術可以幫助我們將新產品推向市場。
So just to summarize, we are looking to invest this money back into expanded growth for the company, enhance our collaboration with growing enterprise account, and continue to invest in the future of mental health and addiction arena.
總而言之,我們希望將這筆資金重新投資於公司的擴張成長,加強與不斷成長的企業帳戶的合作,並繼續投資於心理健康和成癮領域的未來。
Carl Byrnes - Analyst
Carl Byrnes - Analyst
Great. Thank you.
偉大的。謝謝。
Operator
Operator
(Operator Instructions) Raghuram Selvaraju, H.C. Wainwright.
(操作員說明)Raghuram Selvaraju, H.C.溫賴特。
Raghuram Selvaraju - Analyst
Raghuram Selvaraju - Analyst
Thanks very much for taking my questions and congratulations on a very solid end to 2024. Firstly, I wanted to ask if you could comment on the current broader macroeconomic and geopolitical situation and if you expect any of this to pose any unaccustomed challenges or possible opportunities for Brainsway as we look ahead to the rest of 2025, particularly as this pertains to pricing dynamics, as well as uptake in emergent indications for the Deep TMS system.
非常感謝您回答我的問題,並祝賀您在 2024 年取得了圓滿成功。首先,我想問您是否可以評論一下當前更廣泛的宏觀經濟和地緣政治形勢,以及您是否預計這些情況會在 2025 年剩餘時間內給 Brainsway 帶來任何不尋常的挑戰或可能的機遇,特別是因為這涉及到定價動態,以及深度 TMS 系統新興適應症的吸收。
Hadar Levy - Chief Executive Officer
Hadar Levy - Chief Executive Officer
Yeah, we don't see, as of today, any impact on the macroeconomics changes on custom. Brainsway is a US-based company. Most of our business is in the US and most of our team is also based in the US market.
是的,截至今天,我們還沒有看到宏觀經濟變化對習俗產生任何影響。Brainsway 是一家美國公司。我們的大部分業務在美國,我們的大部分團隊也在美國市場。
However, we do see lots of positive tailwinds to our business specifically around some of the new indication that we're about to bring to the market that relates to the mental health industry. I do believe that the accelerated Deep TMS protocol could really mitigate some of the trends that we are seeing in the market.
然而,我們確實看到了許多對我們業務有利的因素,特別是我們即將向市場推出的一些與心理健康產業相關的新跡象。我確實相信加速的深部經顱磁刺激 (Deep TMS) 協議確實可以緩解我們在市場上看到的一些趨勢。
I do think that the PTSD treatment that has been approved by the -- for reimbursement in Israel and we are currently there are some few publication from a very favorable results that have been used by the VA in the US, might increase the interest also on the macroeconomics and we potentially may benefit from it at the end.
我確實認為,創傷後壓力症候群治療已獲以色列政府批准報銷,而且我們目前也發表了一些文章,這些文章都得到了美國退伍軍人事務部 (VA) 的積極使用,這可能會增加人們對宏觀經濟的興趣,我們最終可能會從中受益。
But for your question, the way that we think we see some of the microeconomics, we've got lots of mitigation on the financial side. And the way that we are partnering with our partners down the road, so we remain very positive at that front.
但對於您的問題,我們認為我們看到的一些微觀經濟學,我們在金融方面已經採取了許多緩解措施。以及我們與未來合作夥伴的合作方式,因此我們在這方面仍然非常積極。
Raghuram Selvaraju - Analyst
Raghuram Selvaraju - Analyst
Just as a follow on to that question, I wanted to ask if you can confirm whether there has been in fact no impact to any governmental funding of exploratory work with the Deep TMS system in particular. I recall that one of these initiatives was being supported by NIH funding.
作為該問題的後續,我想問您是否可以確認這是否實際上沒有對政府對 Deep TMS 系統探索性工作的資助產生影響。我記得其中一項措施得到了美國國立衛生研究院 (NIH) 的資助。
As we all have heard, there are cutbacks going on at NIH right now. I just wanted to confirm that this in fact does not affect any of the work that is being done with your system.
眾所周知,美國國立衛生研究院目前正在削減經費。我只是想確認這實際上不會影響您的系統正在進行的任何工作。
Hadar Levy - Chief Executive Officer
Hadar Levy - Chief Executive Officer
Yeah, that's a very good question. I'm not aware of any pushback. I think we made some kind of a publication of granting from the NIH for the specific study. I would say on the contrary, I think that the funding that we, I think, announced was -- relates to the addiction side, which is a very compelling and important disease that I believe the government and also the public wants to see some progress. But as of to date, there was no restrictions for any kind of funding to some of our projects.
是的,這是一個非常好的問題。我不知道有任何阻力。我認為我們已經發表了一些來自美國國立衛生研究院針對該特定研究的資助出版物。我想說的是,恰恰相反,我認為我們宣布的資金與成癮方面有關,這是一種非常引人注目且重要的疾病,我相信政府和公眾都希望看到一些進展。但截至目前為止,我們的一些項目沒有任何形式的資金限制。
Raghuram Selvaraju - Analyst
Raghuram Selvaraju - Analyst
Thank you very much.
非常感謝。
Operator
Operator
This concludes our question-and-answer session. I would like to turn the conference back over to Hadar for any closing remarks.
我們的問答環節到此結束。我想將會議交還給哈達爾,請他做最後發言。
Hadar Levy - Chief Executive Officer
Hadar Levy - Chief Executive Officer
So I would like to thank all of the investors, analysts, and other participants for their interest in Brainsway. With that, please enjoy the rest of your day. Thank you.
因此,我要感謝所有投資者、分析師和其他參與者對 Brainsway 的關注。好了,請盡情享受這一天的剩餘時間。謝謝。
Operator
Operator
The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。