Solana Co (HSDT) 2024 Q2 法說會逐字稿

Good day, and thank you for standing by, and welcome to the Helius Medical Technologies second-quarter 2024 earnings conference call. (Operator instructions) Please be advised that today's conference is being recorded.

美好的一天，感謝您的支持，歡迎參加 Helius Medical Technologies 2024 年第二季財報電話會議。（操作員說明）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your speaker today, Michelle Bilski, Investor Relations for Helius Medical. Please go ahead.

現在，我想將會議交給今天的發言人、Helius Medical 投資者關係部的 Michelle Bilski。請繼續。

Thank you, operator. Welcome to the second-quarter 2024 earnings conference call for Helius Medical Technologies. This is Michelle Bilski of Insight Communications, Investor Relations for Helius. With me on today's call are Dane, Andreeff, Helius Medical's President and Chief Executive Officer; and Jeff Mathiesen, Chief Financial Officer.

謝謝你，接線生。歡迎參加 Helius Medical Technologies 2024 年第二季財報電話會議。我是 Helius 投資者關係 Insight Communications 的 Michelle Bilski。參加今天電話會議的有 Helius Medical 總裁兼執行長 Dane Andreeff；和財務長傑夫馬蒂森。

At this time, all participants have been placed in a listen only mode. Please note that this call is being recorded and access to the webcast can be obtained through the investor section of the Hleius website at www.heliusmedical.com. Before we begin, I would like to remind everyone that our remarks and responses to your questions today may contain forward-looking statements that are based on the current expectations of management.

此時，所有參與者均已置於僅聽模式。請注意，本次電話會議正在錄音，您可以透過 Hleius 網站 www.heliusmedical.com 的投資者部分存取網路廣播。在開始之前，我想提醒大家，我們今天的言論和你們問題的回答可能包含基於管理階層目前預期的前瞻性陳述。

These forward-looking statements, including statements regarding potential reimbursement pricing, involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including those identified in the Risk Factors section of our most recent annual report on Form 10-K and our most recent quarterly report on Form 10-Q.

這些前瞻性陳述，包括有關潛在報銷定價的陳述，涉及固有風險和不確定性，可能導致實際結果與所示結果存在重大差異，包括我們最新10-K 表格年度報告的風險因素部分中確定的那些風險和不確定性，以及我們最新的 10-Q 表格季度報告。

Such factors may be updated from time to time in our other filings with the SEC, which are available on our website All statements made during this call or as of August 12, 2024. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.

這些因素可能會在我們向 SEC 提交的其他文件中不時更新，這些文件可在我們的網站上查看本次電話會議期間或截至 2024 年 8 月 12 日所做的所有聲明。除非法律要求，否則我們不承擔因新資訊、未來事件或其他情況而公開更新或修改我們的前瞻性聲明的義務。

I would now like to turn the call over to Mr. Andreeff.

我現在想把電話轉給安德烈夫先生。

Thanks, Michelle, and thank you, everyone, joining us today on Helius Medical's second-quarter 2024 earnings conference call. During 2024, our priority has been to get PoNS therapy to as many people suffering from MS as possible. We've seen firsthand how our innovative technology makes a meaningful difference in a patient's fight against gait and balance deficit, a common but devastating symptom of MS. And I'm proud to say our efforts during the second quarter and recently have generated significant momentum toward greater access.

謝謝 Michelle，也謝謝大家今天參加 Helius Medical 的 2024 年第二季財報電話會議。2024 年，我們的首要任務是為盡可能多的多發性硬化症患者提供 PoNS 治療。我們親眼目睹了我們的創新技術如何在患者對抗步態和平衡缺陷（多發性硬化症常見但毀滅性的症狀）方面產生有意義的改變。我很自豪地說，我們在第二季和最近的努力已經為擴大訪問產生了巨大的動力。

Specifically in April, we partnered with Lovell government services, an SBA certified service disabled veterans on small business to make plans therapy accessible to MS patients treated at the VA and to our other federal agencies. The VA is the largest integrated health care system in the United States and home to a network of multiple sclerosis centers of excellence.

具體來說，在 4 月份，我們與洛弗爾政府服務機構（SBA 認證的小型企業殘疾退伍軍人服務機構）合作，為在 VA 和我們其他聯邦機構接受治療的多發性硬化症患者提供計劃治療。退伍軍人管理局是美國最大的綜合醫療保健系統，擁有多發性硬化症卓越中心網路。

The VA estimates that between 55,000 and 70,000 veterans in the US live with MS. As the only portable and readily accessible therapy that may lead to neuroplasticity, PoNS is a potential game changer for these veterans and their families. And we're happy to be a preferred provider and help more service members access this treatment.

退伍軍人管理局估計，美國有 55,000 至 70,000 名退伍軍人患有多發性硬化症。作為唯一一種可攜式且易於獲得的可能導致神經可塑性的療法，PoNS 對於這些退伍軍人及其家人來說是一個潛在的遊戲規則改變者。我們很高興成為首選提供者，並幫助更多服務成員獲得這種治療。

Shortly thereafter, in May, PoNS was approved for inclusion in Lovell’s VA federal supply schedule and the General Services Administration Advantage contracts at pricing of $23,843.72 and $7,344.97 for the PoNS device and the PoNs mouthpiece, respectively. Also in May, we received the first third party reimbursement of $23,900 from a major insurance carrier for a PoNS device.

此後不久，即 5 月份，PoNS 被批准納入 Lovell 的 VA 聯邦供應計劃和總務管理局優勢合同，PoNS 設備和 PoNs 喉舌的定價分別為 23,843.72 美元和 7,344.97 美元。同樣在 5 月份，我們從一家主要保險公司收到了第一筆針對 PoNS 設備的第三方報銷 23,900 美元。

Then in July, PoNS was approved for inclusion in Lovell’s DAPA contract for the Department of Defense at $23,724.50 and $7,308.25 for the PoNS device and the PoNS mouthpiece respectively. These were all important accomplishments in establishing market pricing for PoNS as we pursue reimbursement at CMS and third party payers.

然後在 7 月，PoNS 被批准納入 Lovell 為國防部提供的 DAPA 合同，PoNS 設備和 PoNS 喉舌的價格分別為 23,724.50 美元和 7,308.25 美元。當我們向 CMS 和第三方付款人尋求報銷時，這些都是在建立 PoNS 市場定價方面取得的重要成就。

Last quarter, CMS assigned [HCPCS] codes covering the PoNS controller and mouthpiece. And in May, released its preliminary Medicare payment determinations for both. This was a significant reimbursement and access milestones for Helius and we were gratified to know that CMS understood the benefits of this innovative treatment.

上個季度，CMS 分配了涵蓋 PoNS 控制器和介面的 [HCPCS] 代碼。5 月，公佈了兩者的初步醫療保險支付決定。對於 Helius 來說，這是一個重要的報銷和准入里程碑，我們很高興知道 CMS 理解這種創新治療的好處。

We were pleased with this development, but believe there is a strong argument for higher reimbursement rates for both the mouthpiece and controller, which we presented at the CMS public meeting on May 29, as well as in subsequent written communications.

我們對這一進展感到滿意，但相信對於吹嘴和控制器提高報銷率有充分的理由，我們在 5 月 29 日的 CMS 公開會議以及隨後的書面溝通中提出了這一點。

First, we argued that it was appropriate to categorize the mouthpiece as a supply item to be reimbursed on a lump sum payment structure. As a reminder, the mouthpiece has a 14 week life and involves application to a patient's tongue. So therefore, we believe a 13 month cap rental structure is not appropriate.

首先，我們認為將吹嘴歸類為以一次性付款結構報銷的供應項目是適當的。提醒一下，咬嘴的使用壽命為 14 週，並且需要塗抹在患者的舌頭上。因此，我們認為 13 個月的租金上限結構並不合適。

Additionally, we provided recent contract pricing and invoices to support the market pricing at pricing levels I previously discussed to be used for setting of the reimbursement using the GAAP billing method. We also articulated how PoNS is not a neuromuscular peripheral stimulation therapy and therefore, it is not appropriate to map pricing to such devices.

此外，我們還提供了最近的合約定價和發票，以支持我之前討論的定價水平的市場定價，用於使用 GAAP 計費方法設定報銷。我們也闡明了 PoNS 為何不是神經肌肉週邊刺激療法，因此，將定價對應到此類設備是不合適的。

Instead, we argued reimbursement for the controller should be established using the GAAP billing methodology based on market pricing. CMS is expected to publish final reimbursement rates in the coming weeks. Once finalized, the payment rates will be effective October 1, 2024. We are also actively assisting several MS patients as they submit claims with other third party payers on a one-off basis when it comes to secure reimbursement.

相反，我們認為控制者的報銷應該使用基於市場定價的 GAAP 計費方法來確定。CMS 預計將在未來幾週內公佈最終報銷率。一旦最終確定，付款費率將於 2024 年 10 月 1 日生效。我們也積極協助幾位多發性硬化症患者一次向其他第三方付款人提交索賠以獲得報銷。

Beginning in June, we began building out a sales rep organization to service the VA sites throughout the US. To date, we have established sales representatives covering 13 states, including Texas and Florida plus Puerto Rico. We believe having boots on the ground representatives focused on neurological disorders and that have established relationships with the individual VA sites will be critical to building out sales across the VA facilities in the US.

從六月開始，我們開始建立一個銷售代表組織，為美國各地的 VA 站點提供服務。迄今為止，我們已在 13 個州設立了銷售代表，包括德州、佛羅裡達州以及波多黎各。我們相信，擁有專注於神經系統疾病並與各個退伍軍人事務部建立了關係的實地代表對於擴大美國退伍軍人事務部設施的銷售至關重要。

I'll pause for a second to see if Dane has rejoined.

我會暫停一下，看看戴恩是否重新加入。

I have. Jeff, thank you. Let me continue. While much of our focus during the quarter were down removing barriers to access and securing reimbursement. We also made meaningful progress toward our pursuit of stroke authorization in the US where over 5 million stroke survivors are affected by walking and balance disability.

我有。傑夫，謝謝你。讓我繼續。雖然本季我們的大部分重點是消除獲取障礙和確保報銷。我們在美國爭取中風授權方面也取得了有意義的進展，美國有超過 500 萬中風倖存者受到步行和平衡障礙的影響。

The registration program, which includes an investigator, initiated a placebo-controlled study at the Medical University of South Carolina and book rehabilitation and a company-sponsored open-label trial has been fully enrolled. In June, site participation enrollment of the open-label study with the addition of top neuro rehabilitation centers such as REHABOLOGYM, The Neurology Center of New England, and MGH Institute of Health Professions have started enrolling.

該註冊計劃包括一名研究者，在南卡羅來納醫科大學發起了一項安慰劑對照研究，並進行了圖書康復和公司贊助的開放標籤試驗，該試驗已全部入組。6 月，開放標籤研究的現場參與招募已開始招募，其中包括 REHABOLOGYM、新英格蘭神經病學中心和 MGH 健康專業研究所等頂級神經復健中心。

This groundbreaking registrational program, which also has the participation of Brooks Rehabilitation and Shepherd Center to the open label study designed to establish the effects of cranial nerve noninvasive neuromodulation delivered using PoNS therapy on gait and balance and chronic stroke survivors. It will also establish PoNS therapeutic impact on the risk of falling in US patients.

這項開創性的註冊計劃也得到了布魯克斯復健和牧羊人中心的參與，該研究旨在確定使用 PoNS 療法進行腦神經非侵入性神經調節對步態和平衡以及慢性中風倖存者的影響。它還將確定 PoNS 治療對美國患者跌倒風險的影響。

In addition to enrolling 60 participants to the MUSC study, we anticipate enrolling approximately 30 patients into the open label study across all sites. By the end of the third quarter, I expect the results will significantly bolster our FDA submission when we submit for regulatory approval in 2025. The stroke registrational program was established in part based on real-world evidence from Canada, where Poland is already authorized for the treatment of stroke.

除了招募 60 名參與者參加 MUSC 研究之外，我們預計還將招募約 30 名患者參加所有地點的開放標籤研究。到第三季末，我預計當我們在 2025 年提交監管審批時，結果將極大地支持我們向 FDA 提交的申請。中風登記計劃的製定部分基於來自加拿大的真實世界證據，波蘭已被授權用於治療中風。

To further strengthen the data package submission for FDA authorization and support national reimbursement in Canada, we've begun an additional Canadian study on the use of PoNS therapy to treat stroke with the goal of enrolling 40 to 60 subjects by the end of 2024 at three centers of excellence for stroke rehabilitation.

為了進一步加強向 FDA 授權提交資料包並支持加拿大的國家報銷，我們在加拿大啟動了另一項關於使用 PoNS 療法治療中風的研究，目標是到 2024 年底前招募 40 至 60 名受試者中風復健卓越中心。

This study, which has received approval by the institutional view Board in June has already started participants enrollment. A new research program to extend established evidence of the effect of on-label PoNS on risk of falling and stroke patients with gait and balance deficit in Canada has also begun enrolling patients with TBIMS at three top Canadian neuro rehabilitation sites in May.

這項研究已於 6 月獲得機構觀點委員會的批准，現已開始參與者招募。一項新的研究計劃旨在擴大標籤上的 PoNS 對加拿大步態和平衡缺陷患者跌倒和中風風險的影響的既定證據，該計劃也於 5 月開始在加拿大三個頂級神經復健中心招募 TBIMS 患者。

We're excited about where we stand at the midyear of the year. We secured reimbursement with a major third-party insurer and the expected Medicare price determination to be effective October 1 will enable us to further expand reimbursement across third party payers. The number of PoNS trained therapists in the field has grown, and our FDA submission for stroke remains on track.

我們對年中的表現感到興奮。我們透過一家主要的第三方保險公司獲得了報銷，預計 Medicare 價格確定將於 10 月 1 日生效，這將使我們能夠進一步擴大對第三方付款人的報銷範圍。在該領域接受過 PoNS 培訓的治療師數量有所增加，我們向 FDA 提交的中風申請仍在按計劃進行。

Given all that we put into place, we see a clear path ahead toward achieving our main goal of removing barriers and helping more people benefit from PoNS. And with the $6.4 million of financing we announced in May, we extended our runway to cover the key 2024 milestones.

鑑於我們所做的一切，我們看到了一條清晰的道路，可以實現消除障礙並幫助更多人從 PoNS 中受益的主要目標。透過我們 5 月宣布的 640 萬美元融資，我們擴展了我們的跑道，以實現 2024 年的關鍵里程碑。

I'll now turn the call over to Jeff to discuss our second quarter financial results in more detail.

我現在將把電話轉給傑夫，更詳細地討論我們第二季的財務表現。

Thanks, Dane. Again, it's a pleasure to be with you today. Total revenue for the second quarter of 2024 was $182,000, a decrease of $74,000 compared to $256,000 in the second quarter of 2023. As a result of the termination of our patient therapy access program on June 30, 2023 and the termination of temporary cash pay pricing in May of 2024.

謝謝，丹恩。再次，很高興今天能和大家在一起。2024 年第二季的總收入為 182,000 美元，比 2023 年第二季的 256,000 美元減少了 74,000 美元。由於我們的病患治療取得計畫於 2023 年 6 月 30 日終止，臨時現金支付定價於 2024 年 5 月終止。

Revenue for the quarter was up 35% compared to the first quarter of 2024 as a result of increased sales in both the US and Canada. For the second quarter of 2024, cost of revenue was $118,000 compared to $184,000 for the prior year period, primarily attributable to lower sales compared to the same period in the prior year.

由於美國和加拿大的銷售額增加，本季營收較 2024 年第一季成長 35%。2024 年第二季度，收入成本為 118,000 美元，而去年同期為 184,000 美元，主要是由於銷售額較上年同期下降。

Selling, general and administrative expenses for the second quarter of 2024 were $2.5 million compared to remaining relatively flat when compared to the $2.6 million reported in the second quarter of 2023.

2024 年第二季的銷售、一般和管理費用為 250 萬美元，與 2023 年第二季報告的 260 萬美元相比，相對持平。

Research and development expenses for the second quarter of 2024 was $0.9 million compared to $0.7 million in the second quarter of 2023, driven primarily by an increase in clinical trial activities for stroke and risk of fall programs.

2024 年第二季的研發費用為 90 萬美元，而 2023 年第二季的研發費用為 70 萬美元，主要是由於中風和跌倒風險計畫的臨床試驗活動增加所致。

Total expenses for the second quarter of 2024 were $3.3 million, flat when compared to $3.3 million in the second quarter of 2023. Operating loss for the second quarter of 2024 was $3.2 million compared to a loss of $3.2 million for the prior year period. We reported a net loss for the second quarter of 2024 of $1.6 million or a loss of $0.64 per basic and diluted common share.

2024 年第二季的總支出為 330 萬美元，與 2023 年第二季的 330 萬美元持平。2024 年第二季的營運虧損為 320 萬美元，而去年同期為虧損 320 萬美元。我們報告 2024 年第二季的淨虧損為 160 萬美元，即每股基本股和稀釋普通股虧損 0.64 美元。

We also had a net loss of $1.6 million in the prior year period for a loss of $2.92 per basic and diluted common share, due to a higher number of weighted average shares outstanding. Our cash burn from operations was flat at $5.9 million for the 6 months ended June 30, 2024 and June 30, 2023. As of June 30, 2024, we had $6.4 million in cash and no debt.

由於已發行加權平均股數量較多，我們上一年期間的淨虧損為 160 萬美元，每股基本股和稀釋普通股虧損 2.92 美元。截至2024年6月30日及2023年6月30日的六個月，我們的營運現金消耗持平於590萬美元。截至 2024 年 6 月 30 日，我們擁有 640 萬美元現金，沒有債務。

In May, we closed on $6.4 million public offering and received net proceeds of $5.5 million, which will extend our cash runway into 2025. This financing also includes one year warrants for an additional $6.4 million of gross proceeds that are callable by the company within 30 days of announcing the final reimbursement determination for PoNS controller and mouth piece by CMS.

5 月份，我們完成了 640 萬美元的公開發行，並獲得了 550 萬美元的淨收益，這將使我們的現金跑道延長至 2025 年。此次融資還包括額外 640 萬美元總收益的一年期認股權證，該認股權證可由公司在 CMS 宣布 PoNS 控制器和喉舌的最終報銷決定後 30 天內贖回。

Yet the stock price trades at or above $2.25 per share for five consecutive days during that period. We expect the final determination will be announced in late summer and effective October 1 of this year. If exercised, the additional proceeds from these warrants will fund our operations well into the second half of next year.

然而，在此期間，股價連續五天處於或高於每股 2.25 美元。我們預計最終決定將於夏末公佈，並於今年 10 月 1 日生效。如果行使，這些認股權證的額外收益將為我們明年下半年的營運提供資金。

Turning now to our outlook. To date, PoNS sales have been muted due to the fact that they have primarily been on a cash pay basis. And as a price point, that is not feasible for the vast majority of the patients in our addressable markets. However, with our recent inroads into the VA and the expected Medicare reimbursement to be effective October 1 of this year, we believe we are positioned to significantly boost our revenues beginning later this year, providing us a pathway to positive cash flow.

現在轉向我們的展望。迄今為止，PoNS 銷售一直處於低迷狀態，因為它們主要以現金支付為基礎。從價格角度來看，這對於我們目標市場中的絕大多數患者來說是不可行的。然而，隨著我們最近進軍 VA 以及預計醫療保險報銷將於今年 10 月 1 日生效，我們相信我們將在今年稍後開始顯著提高我們的收入，為我們提供一條實現正現金流的途徑。

With that, Daniel, let's now open the call for questions.

丹尼爾，現在讓我們開始提問。

(Operator instructions)

（操作員說明）

Anthony Vendetti, Maxim Group.

安東尼文代蒂，馬克西姆集團。

Thanks. So once the final price determination is received from CMS. Do you have like a pipeline of patients? And how do you think that will, what would that impact be on initial sales? And then I have a follow-up on stroke.

謝謝。一旦收到 CMS 的最終價格決定。您有類似的患者管道嗎？您認為這會對初始銷售產生什麼影響？然後我對中風進行了隨訪。

Yes, hi, Anthony. It's Dane. Thanks for your question. We have been keeping a long list of Medicare patients with their prescribers. Of course, their insurance, which is Medicare because we cannot file one-off claims right now waiting, for CMS and Medicare reimbursement. So we do have a very strong list of built-up demand regarding Medicare.

是的，嗨，安東尼。是丹恩。謝謝你的提問。我們一直保留著一長串醫療保險患者及其處方者的名單。當然，他們的保險是 Medicare，因為我們現在無法提交一次性索賠，等待 CMS 和 Medicare 報銷。因此，我們確實有一個非常強大的醫療保險相關需求清單。

Okay, great. And then, just wondering, where are you with patient enrollment for the stroke trial? And are you still on target for a completing it and then submitting to the FDA in the first half of '25?

好的，太好了。然後，我想知道，中風試驗的患者入組情況在哪裡？您是否仍計劃在 25 年上半年完成並提交給 FDA？

We are on track. Enrollment is on track as well as the submitting in the first half of 2025.

我們步入正軌。報名工作正按計畫進行，並將於 2025 年上半年提交。

Okay, great.

好的，太好了。

And Anthony, if you remember, we'll be using on top of that our second FDA breakthrough designation, which truly gives us a wonderful pathway forward with 150 day notice period.

安東尼，如果你還記得的話，我們將在 FDA 的第二個突破性指定的基礎上使用它，這確實為我們提供了 150 天通知期的美好途徑。

Okay. Great. No, that's helpful. And then I guess one last question. Where are you with potential studies or expansion for TBI?

好的。偉大的。不，這很有幫助。然後我猜最後一個問題。您對 TBI 的潛在研究或擴展在哪裡？

Right now, we're still investigating that expansion into TBI. As you are aware, we had Pacific Blue Cross do their own study for back to work, which came out with a white paper late last year, where eight of the nine of their long-term disability claims stated that balance and gait after using PoNS therapy for 14 weeks, that eight of the nine of their long-term disability patients and claimants had no longer balancing gait issues to go back to work.

目前，我們仍在調查 TBI 的擴展。如您所知，我們讓Pacific Blue Cross 為重返工作崗位做了自己的研究，該研究於去年年底發布了一份白皮書，其中9 份長期殘疾索賠中的8 份表示，使用PoNS 後平衡和步態會受到影響經過 14 週的治療，9 名長期殘疾患者和索賠人中有 8 名不再平衡步態問題以重返工作崗位。

Five of the nine went back to work in PoNS therapy, saved Pacific Blue Cross approximately $1.6 million. So a significant cost-benefit analysis that is heavily weighted towards using PoNS therapy for traumatic brain injury patients.

9 人中的 5 人重返 PoNS 治療工作，為 Pacific Blue Cross 節省了約 160 萬美元。因此，一項重要的成本效益分析重點在於對創傷性腦損傷患者使用 PoNS 療法。

Okay. No, that's helpful. Thanks for that color again. I'll hop back in the queue. Appreciate it.

好的。不，這很有幫助。再次感謝這個顏色。我會跳回到隊列中。欣賞它。

Great. Thanks, Anthony.

偉大的。謝謝，安東尼。

(Operator instructions) I'm showing no further questions at this time. I would now like to turn it back to Dane Andreff for closing remarks.

（操作員說明）我目前沒有提出任何進一步的問題。現在我想請戴恩·安德烈夫 (Dane Andreff) 發表結束語。

Great. Thank you, Daniel. My apologies again for the technical difficulties, but just thank you for following Helius Medical Technologies. As you've heard today, we're excited about where we stand at this point in the year and truly look forward to keeping you updated as we pursue coverage in reimbursement and authorization for stroke. So thank you very much.

偉大的。謝謝你，丹尼爾。對於技術上的困難，我再次表示歉意，但感謝您關注 Helius Medical Technologies。正如您今天所聽到的，我們對今年此時此刻的情況感到興奮，並真誠地期待在我們追求中風報銷和授權的過程中向您通報最新情況。非常感謝。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。