Avinger Inc (AVGR) 2024 Q2 法說會逐字稿

Welcome to the Avinger second quarter 2024 results call.

歡迎參加 Avinger 2024 年第二季業績電話會議。

(Operator Instructions) I'll now turn the call over to your host, Matt Kreps, investor relations.

（操作員說明）我現在將把電話轉給主持人 Matt Kreps，投資者關係部。

You may begin.

你可以開始了。

Thank you, and thank you all for joining us on today's call.

謝謝大家，也謝謝大家參加今天的電話會議。

I would like to welcome you to Avinger second quarter 2024 conference call.

歡迎您參加 Avinger 2024 年第二季電話會議。

Joining us today are Avinger CEO, Jeff Soinski; and Principal Financial Officer, Nabeel Subainati.

今天加入我們的是 Avinger 執行長 Jeff Soinski；財務長 Nabeel Subainati。

Earlier today, we released financial results for the quarter ended June 30, 2024.

今天早些時候，我們發布了截至 2024 年 6 月 30 日的季度財務業績。

A copy of the release is posted on the Avinger website under investor relations.

新聞稿的副本發佈在 Avinger 網站的投資者關係欄位下。

Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of private securities litigation reform act of 1995.

在我們開始之前，我想提醒您，管理層將在本次電話會議期間發表聲明，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明是根據1995 年私人證券訴訟改革法案的安全港條款制定的。

Any statements contained in this call, they're not statements of historical fact, should be deemed to be forward-looking statements.

本次電話會議中包含的任何陳述，不是歷史事實的陳述，應被視為前瞻性陳述。

All forward-looking statements, including without limitation or future financial expectations, and expected timing for commercial launch of products and filings with the FDA are based upon current estimates and various assumptions.

所有前瞻性陳述，包括但不限於未來財務預期、產品商業上市的預期時間以及向 FDA 提交的文件均基於當前的估計和各種假設。

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

這些陳述涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件有重大差異。

Accordingly, you should not place undue reliance on these statements.

因此，您不應過度依賴這些陳述。

For a list and description of the risks and uncertainties associated with our business, please see our form 10-K and 10-Q filings with the Securities and Exchange Commission.

有關與我們業務相關的風險和不確定性的清單和描述，請參閱我們向美國證券交易委員會提交的 10-K 和 10-Q 表格。

Avinger disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise.

除法律要求外，無論是由於新資訊、未來事件或其他原因，Avinger 不承擔任何更新或修改任何財務預測或前瞻性陳述的意圖或義務。

Also, today's presentation will include reference to non-GAAP financial measures, such as adjusted EBITDA.

此外，今天的演示將包括參考非公認會計準則財務指標，例如調整後的 EBITDA。

A reconciliation of these non-GAAP financial measures to the most comparable GAAP financial measures is available within the earnings release, which can be found on Avinger's website.

這些非公認會計原則財務指標與最具可比性的公認會計原則財務指標的調節可在收益報告中找到，該報告可以在 Avinger 的網站上找到。

And with that, I'd like to now turn the call over to Jeff.

現在我想把電話轉給傑夫。

Thank you, Matt.

謝謝你，馬特。

Good afternoon, and thank you all for joining us.

下午好，感謝大家加入我們。

The second quarter marked significant progress for Avinger's therapeutic programs, as well as a meaningful shift in our operating structure as we move our company forward.

第二季標誌著 Avinger 的治療計畫取得了重大進展，隨著我們公司的發展，我們的營運結構也發生了有意義的轉變。

Following the March announcement of our new strategic partnership with Zylox-Tonbridge, which provided a substantial investment into Avinger and opens a pathway for the introduction of our image-guided devices to the greater China market, we further improved our balance sheet in the second quarter.

繼3 月宣布與Zylox-Tonbridge 建立新的策略合作夥伴關係（Zylox-Tonbridge 為Avinger 提供了大量投資，並為將我們的圖像引導設備引入大中華市場開闢了道路）之後，我們在第二季度進一步改善了我們的資產負債表。

In May, we announced the conversion of $11 million of debt held by CRG into shares of a new series of convertible preferred stock, which increased stockholders' equity by the same amount.

5 月份，我們宣布將 CRG 持有的 1,100 萬美元債務轉換為一系列新的可轉換優先股，增加了同等金額的股東權益。

In June, we announced a public offering providing up to $24 million in growth financing.

6 月，我們宣佈公開發行，提供高達 2,400 萬美元的成長融資。

The financing included $6 million up front at closing, with up to an additional $18 million available based upon the exercise in full of coronary clinical milestone-linked warrants.

此次融資包括交割時預付的 600 萬美元，以及根據冠狀動脈臨床里程碑相關認股權證的行使情況最多可額外獲得 1800 萬美元。

In June, we also implemented an operating cost savings program that reduced our head count by approximately 24%.

6 月份，我們還實施了一項營運成本節約計劃，將員工人數減少了約 24%。

This cost reduction program streamlines the operating cost of our peripheral business as we emphasize our field sales team support of existing peripheral device users and allows us to increase focus on our coronary product development program.

這項成本削減計劃簡化了我們的外圍設備業務的營運成本，因為我們強調我們的現場銷售團隊對現有周邊設備用戶的支持，並使我們能夠更加關注我們的冠狀動脈產品開發計劃。

We expect the full effect of the cost reductions to be seen in the second half of 2024, with both improved gross margin and reduced operating costs anticipated in the period.

我們預計成本削減的全部效果將在 2024 年下半年顯現，毛利率將提高，營運成本將降低。

Turning to some of the key operating accomplishments in the quarter, we continued to make exciting progress on our first coronary product as we prepare for filing an IDE submission with the FDA.

談到本季度的一些關鍵營運成就，我們在準備向 FDA 提交 IDE 申請時，我們的第一個冠狀動脈產品繼續取得令人興奮的進展。

We are in the process of completing Phase 3 verification and validation studies and initial clinical site selection for our proprietary CTO crossing device.

我們正在完成我們專有的 CTO 交叉設備的 3 期驗證和確認研究以及初步臨床地點選擇。

Pending successful completion of the remaining testing, we anticipate filing an IDE application with the FDA by the end of the third quarter.

在成功完成剩餘測試之前，我們預計在第三季末向 FDA 提交 IDE 申請。

This is a critical step for Avinger since FDA approval of our IDE submission would allow Avinger to initiate the first human clinical study for this groundbreaking new device and brings us one step closer to making our proprietary image-guided system available to physicians treating this challenging and complex condition in the coronary arteries.

這對Avinger 來說是關鍵的一步，因為FDA 批准我們的IDE 提交將使Avinger 能夠針對這種突破性的新設備啟動首次人體臨床研究，並使我們更接近於讓我們的專有圖像引導系統可供醫生治療這種具有挑戰性和挑戰性的疾病。

We believe our first coronary device provides the opportunity to redefine a large and underserved market.

我們相信，我們的第一個冠狀動脈設備提供了重新定義龐大且服務不足的市場的機會。

Crossing chronic total occlusions in the coronary arteries today is typically a complex, time-consuming, and expensive procedure with a clinically documented high failure rate.

如今，穿越冠狀動脈慢性完全阻塞通常是一項複雜、耗時且昂貴的手術，臨床記錄的失敗率很高。

By leveraging our proprietary image-guided technology, we believe we can provide physicians with a superior, simplified, and more successful solution for crossing coronary CTOs.

透過利用我們專有的影像引導技術，我們相信我們可以為醫生提供卓越、簡化且更成功的冠狀動脈 CTO 解決方案。

We have deployed our technologies into a low-profile, four-french catheter design that combines real-time OCT guidance with the precise control and steerability needed to facilitate an integrated approach, which we expect to significantly reduce procedure times and improve crossing success rates.

我們已將我們的技術部署到低調的四法式導管設計中，該設計將實時OCT 引導與促進集成方法所需的精確控制和可操縱性相結合，我們預計這將顯著減少手術時間並提高穿越成功率。

Like our peripheral catheters, our coronary device incorporates a precise measurement capability to help physicians properly size balloons or stents prior to placement, which is critical for optimal outcomes.

與我們的外周導管一樣，我們的冠狀動脈裝置具有精確的測量功能，可幫助醫生在放置前正確確定球囊或支架的尺寸，這對於最佳結果至關重要。

We expect our unique image-guided system to allow physicians to cross coronary CTOs with less reliance on specialty wires, support catheters, and re-entry devices, while also limiting x-ray radiation exposure and usage of iodine-containing contrast dye, which can pose significant health risks to physicians and patients.

我們期望我們獨特的影像引導系統能夠讓醫生在穿越冠狀動脈 CTO 時減少對專用導線、支撐導管和再進入裝置的依賴，同時也限制 X 射線輻射暴露和含碘對比染料的使用，這可以對醫生和患者造成重大健康風險。

Based on multiple animal and cadaver heart studies completing during our development process and extensive experience with our OCT-guided therapy in the peripheral arteries, we are confident our combination of onboard image guidance and precise control within the vessel will support a robust safety profile during clinical practice.

基於我們在開發過程中完成的多項動物和屍體心臟研究以及我們在周邊動脈OCT 引導治療方面的豐富經驗，我們相信我們的機載影像引導和血管內精確控制的結合將支持臨床期間的穩健安全性。

We expect adoption of our coronary CTO crossing system to benefit from existing reimbursement dynamics.

我們預計採用我們的冠狀動脈 CTO 交叉系統將從現有的報銷動態中受益。

Following FDA clearance, our coronary device would immediately access existing high-value reimbursement codes for CTO crossing in the coronary arteries.

在 FDA 批准後，我們的冠狀動脈設備將立即存取現有的高價值 CTO 穿越冠狀動脈的報銷代碼。

We also expect our image-guided system to access existing reimbursement codes for coronary OCT diagnostic imaging with the same device.

我們也希望我們的影像引導系統能夠使用相同裝置存取冠狀動脈 OCT 診斷影像的現有報銷代碼。

This is a key differentiator from the peripheral markets, where discrete reimbursement codes for CTO crossing and diagnostic OCT imaging are not currently available.

這是與外圍市場的關鍵區別，外圍市場目前尚不提供 CTO 交叉和診斷 OCT 成像的離散報銷代碼。

In addition to attractive reimbursement dynamics, we expect our coronary CTO crossing system to allow for reduced crossing time, less contrast media usage, and require the use of fewer accessory devices, all of which would result in significant cost savings for the hospital system.

除了有吸引力的報銷動態之外，我們預計我們的冠狀動脈 CTO 穿越系統能夠減少穿越時間、減少造影劑的使用，並需要使用更少的輔助設備，所有這些都將為醫院系統節省大量成本。

We're excited to advance this revolutionary product through the clinical and regulatory process and look forward to providing further updates on our progress in the coming quarters.

我們很高興能夠透過臨床和監管流程來推進這項革命性產品，並期待在未來幾季提供有關我們進展的進一步更新。

While we've reduced head count and streamlined operations for our peripheral business, we have taken steps to ensure our image-guided catheters remain available to treat patients with clinically challenging peripheral artery disease.

雖然我們減少了周邊業務的員工人數並簡化了運營，但我們已採取措施確保我們的影像引導導管仍然可以用於治療患有臨床挑戰性週邊動脈疾病的患者。

We've maintained a field presence in existing sales territories and are focusing our clinical specialists and sales reps on supporting current users while seeking growth opportunities within or in close proximity to existing accounts.

我們在現有銷售區域保持了現場存在，並讓我們的臨床專家和銷售代表專注於支持現有用戶，同時在現有客戶內或附近尋求成長機會。

Underscoring our commitment to the clinical importance of our image-guided approach, earlier this week we announced an important new addition to our leadership team.

為了強調我們對影像引導方法的臨床重要性的承諾，本週早些時候，我們宣布了領導團隊的重要新成員。

Dr. Tom Davis, a practicing interventional cardiologist and one of the preeminent leaders in the treatment of vascular disease, has joined Avinger as Chief Medical Officer.

Tom Davis 博士是一位執業介入性心臟病專家，也是血管疾病治療領域的傑出領導者之一，他已加入 Avinger 擔任首席醫療官。

Dr. Davis serves as director of cardiovascular research at St. John Hospital and Medical Center in Detroit, Michigan, and has served on several scientific advisory boards for interventional device development.

戴維斯博士擔任密西根州底特律聖約翰醫院和醫療中心心血管研究主任，並曾在多個介入設備開發科學顧問委員會任職。

Dr. Davis has authored numerous publications, presented extensively on the podium at clinical conferences, and participated as an investigator or principal investigator in multiple clinical trials for new endovascular technologies, including several of Avinger's clinical studies.

Davis 博士撰寫了大量出版物，在臨床會議的講台上進行了廣泛的演講，並作為研究者或主要研究者參與了多項新型血管內技術的臨床試驗，包括 Avinger 的多項臨床研究。

We're excited to have Dr. Davis join the team and look forward to working closely with him on clinical strategy and medical affairs initiatives to advance our clinical and product development programs and drive awareness of Avinger's image-guided therapies in the broader medical community.

我們很高興 Davis 博士加入團隊，並期待與他在臨床戰略和醫療事務計劃方面密切合作，以推進我們的臨床和產品開發計劃，並提高更廣泛的醫學界對 Avinger 影像引導療法的認識。

We've also made important progress in the commercialization of our new peripheral products, along with the introduction of our new TigerEye ST crossing catheter in the second half of 2023.

我們在新周邊產品的商業化方面也取得了重要進展，並於 2023 年下半年推出了新型 TigerEye ST 交叉導管。

We've completed the limited launch phase of our new Pantheris LV peripheral atherectomy catheter and are building product inventory for full commercial launch in the coming weeks.

我們已經完成了新型 Pantheris LV 週邊動脈粥狀斑塊切除導管的有限發布階段，並正在為未來幾週內全面商業發佈建立產品庫存。

Our new Pantheris LV image-guided atherectomy system is designed to streamline the atherectomy procedure and, in combination with our Lightbox 3 imaging console, expand the mainstream appeal of our image-guided platform.

我們的新型 Pantheris LV 影像引導斑塊切除系統旨在簡化斑塊切除程序，並與我們的 Lightbox 3 成像控制台相結合，擴大我們影像引導平台的主流吸引力。

LV stands for large vessel, and consistent with its name, Pantheris LV is ideal for the treatment of the larger arteries above and behind the knee, where the majority of PAD procedures are performed today.

LV 代表大血管，正如其名稱一樣，Pantheris LV 非常適合治療膝蓋上方和後方的較大動脈，目前大多數 PAD 手術都是在膝蓋上進行的。

Pantheris LV does not require a balloon for plaque apposition and operates at significantly higher rotational speeds than our current atherectomy offerings, with variable speeds up to 3,000 RPMs.

Pantheris LV 不需要球囊來進行斑塊對位，其運行速度明顯高於我們目前的斑塊切除術產品，可變速度高達 3,000 RPM。

Based on our learnings from limited launch and the clinical outcomes we see physicians delivering with this streamlined new device, we're excited to get Pantheris LV into the hands of more physicians through the commercial launch process.

根據我們從有限發布中獲得的經驗以及我們看到醫生使用這款簡化的新設備提供的臨床結果，我們很高興透過商業發布過程將 Pantheris LV 交給更多醫生。

Before I close, I'd also like to provide a quick update on our strategic partnership with Zylox-Tonbridge.

在結束之前，我還想簡要介紹一下我們與 Zylox-Tonbridge 的策略合作夥伴關係的最新情況。

As a reminder, Zylox is a fully integrated medical device company and a leader in the peripheral vascular and neurovascular markets in China.

需要提醒的是，Zylox 是一家完全整合的醫療器材公司，也是中國週邊血管和神經血管市場的領導者。

Zylox has developed and launched numerous products into the greater China market, operates an extensive sales and marketing network, and maintains a state-of-the-art manufacturing facility in Hangzhou, China.

Zylox 已開發並向大中華市場推出眾多產品，經營著廣泛的銷售和行銷網絡，並在中國杭州擁有最先進的製造工廠。

Since closing Zylox's $7.5 million first tranche investment in March, we've worked closely with Zylox operating teams to support their efforts in gaining regulatory approval to sell Avinger's peripheral products in the greater China region, as well as establishing their own manufacturing capability for our products.

自從三月完成 Zylox 750 萬美元的第一筆投資以來，我們與 Zylox 營運​​團隊密切合作，支持他們獲得監管部門批准在大中華地區銷售 Avinger 的外圍產品，並為我們的產品建立自己的製造能力。

We could not be more impressed with the professionalism of the Zylox organization and are excited to support their goal of commercializing our image-guided catheters in the China market in 2025.

Zylox 組織的專業精神給我們留下了深刻的印象，並且很高興能夠支持他們的目標，即 2025 年在中國市場實現我們的圖像引導導管的商業化。

As previously disclosed, sales of Avinger products in the Zylox territory will be royalty- bearing to Avinger and, following regulatory approval, Avinger will sell finished goods to Zylox until their self-manufactured products are available for sale in China.

如同先前所揭露的，Avinger 產品在 Zylox 地區的銷售將向 Avinger 支付特許權使用費，並且在獲得監管部門批准後，Avinger 將向 Zylox 銷售成品，直至其自製產品可在中國銷售。

In addition, once Zylox has qualified their own manufacturing capability and been successfully registered as a manufacturer of Avinger's products with the US FDA, Avinger will have the option to source finished product from Zylox.

此外，一旦 Zylox 具備了自身的製造能力，並成功在美國 FDA 註冊為 Avinger 產品的製造商，Avinger 將可以選擇從 Zylox 購買成品。

We believe this could provide the opportunity for Avinger to reduce cost of goods sold, improve gross margin, and reduce facility and related overhead expense in the future.

我們相信，這可以為 Avinger 提供機會，以降低未來的銷售成本、提高毛利率並減少設施和相關管理費用。

At this point, I'd like to turn the call over to Nabeel Subainati, our Principal Financial Officer and Accounting Officer, to take us through the financial results.

現在，我想將電話轉給我們的財務長兼會計長 Nabeel Subainati，讓我們了解財務業績。

I'll then return for Q&A.

然後我會回來進行問答。

Nabeel

納比爾

?

？

Thank you, Jeff.

謝謝你，傑夫。

Total revenue was $1.8 million for the second quarter of 2024, compared with $1.9 million in the first quarter of 2024 and $2 million in the second quarter of 2023, reflecting the impact of reduced field sales headcount in the last month of the quarter.

2024 年第二季的總收入為180 萬美元，而2024 年第一季的總收入為190 萬美元，2023 年第二季的總收入為200 萬美元，反映了該季度最後一個月現場銷售人員減少的影響。

Gross margin for the second quarter of 2024 was 20% , compared with 18% in the first quarter of 2024 and 30% in the second quarter of 2023.

2024年第二季的毛利率為20%，而2024年第一季的毛利率為18%，2023年第二季的毛利率為30%。

The change in gross margin primarily reflects lower production activity during the quarter as we continue to optimize inventory levels while conserving cash expenditures.

毛利率的變化主要反映了本季生產活動的減少，因為我們繼續優化庫存水平，同時節省現金支出。

Operating expenses for the second quarter of 2024 were $4.5 million, compared with $5.4 million in the first quarter of 2024 and $4.3 million in the second quarter of 2023.

2024 年第二季的營運費用為 450 萬美元，而 2024 年第一季的營運費用為 540 萬美元，2023 年第二季的營運費用為 430 萬美元。

In June, we reduced our headcount by approximately 24% as we refocused our peripheral business activities.

6 月份，隨著我們重新調整外圍業務活動的重點，我們的員工人數減少了約 24%。

Severance and other separation costs associated with this action were included in the second quarter, so we expect to see the benefit of these cost reductions starting in the third quarter of this year, with both improved gross margin and reduced operating expenses anticipated in the second half of 2024.

與此行動相關的遣散費和其他離職成本已計入第二季度，因此我們預計從今年第三季度開始就會看到這些成本削減的好處，預計下半年毛利率會提高，營運費用也會減少2024 年。

Net loss and comprehensive loss for the second quarter of 2024 was $4.4 million, compared with $5.5 million in the first quarter of 2024 and $4.2 million in the second quarter of 2023.

2024 年第二季的淨虧損和綜合虧損為 440 萬美元，而 2024 年第一季為 550 萬美元，2023 年第二季為 420 萬美元。

Adjusted EBITDA, as defined under our non-GAAP financial measures provided in today's press release, was a loss of $3.8 million, compared to a loss of $3.9 million in the first quarter of 2024 and a loss of $3.4 million in the second quarter of 2023.

根據今天新聞稿中提供的非公認會計準則財務指標的定義，調整後 EBITDA 虧損 380 萬美元，而 2024 年第一季虧損 390 萬美元，2023 年第二季虧損 340 萬美元。

For more information regarding non-GAAP financial measures, please see non-GAAP financial measures and the reconciliation of non-GAAP measures to the nearest GAAP measure provided in the tables in today's press release.

有關非 GAAP 財務指標的更多信息，請參閱今天新聞稿表格中提供的非 GAAP 財務指標以及非 GAAP 指標與最接近的 GAAP 指標的調整表。

We continue to take steps to improve our balance sheet in the second quarter, with cash and cash equivalents totaling $8.8 million as of June 30.

我們在第二季繼續採取措施改善資產負債表，截至 6 月 30 日，現金和現金等價物總額為 880 萬美元。

In May, we announced the conversion of $11 million or approximately 80% of CRG debt into shares of a new series of convertible preferred stock, reducing the outstanding principal amount of debt to $2.6 million with no principal payments required until 2027.

5 月，我們宣布將1,100 萬美元（即CRG 約80% 的債務）轉換為一系列新的可轉換優先股，將未償債務本金減少至260 萬美元，並且在2027 年之前無需支付本金。

The debt conversion resulted in an $11 million increase in stockholders' equity.

債務轉換導致股東權益增加 1,100 萬美元。

In June 2024, we announced a public offering valued at up to $24 million in total proceeds, including $6 million of upfront and up to an additional $18 million of aggregate gross proceeds upon the exercise in full of coronary clinical milestone linked warrants.

2024 年6 月，我們宣布進行公開發行，總收益高達2,400 萬美元，其中包括600 萬美元的預付款，以及在全額行使冠狀動脈臨床里程碑相關認股權證後額外獲得的總收益高達1,800 萬美元。

At this point, I'd like to turn the call back to Jeff for Q&A.

此時，我想將電話轉回傑夫進行問答。

Thanks, Nabeel.

謝謝，納比爾。

The second quarter has been busy for Avinger.

第二季度對阿文傑來說很忙碌。

As we refocused our peripheral business and reduced our operating cost structure, advanced our coronary CTO program towards IDE filing, supported Zylox's commercialization efforts for entry into the vast and growing greater China market, and prepared our new Pantheris LV atherectomy catheter for full commercial launch.

隨著我們重新聚焦外圍業務並降低營運成本結構，將冠狀動脈CTO 計劃推進到IDE 備案，支持Zylox 進入廣闊且不斷增長的大中華市場的商業化努力，並為全面商業推出準備我們的新型Pantheris LV斑塊切除導管。

As Nabeel highlighted, we also took important steps to improve our balance sheet and increase stockholders' equity during the quarter.

正如納比爾所強調的那樣，本季我們還採取了重要措施來改善資產負債表並增加股東權益。

We believe we're well-positioned going into the second half of the year and look forward to reporting our continued progress in the coming months.

我們相信，我們在進入今年下半年時處於有利位置，並期待在未來幾個月報告我們的持續進展。

At this point, we'd be happy to take your questions.

此時，我們很樂意回答您的問題。

(Operator Instructions) Ramakanth Swayampakula, H.C. Wainwright & Co.

（操作員說明）Ramakanth Swayampakula, H.C.溫賴特公司

Good afternoon, Jeff and Nabeel.

下午好，傑夫和納比爾。

Thanks for doing this.

感謝您這麼做。

So, in the prepared remarks, we were talking about cost reduction and trying to lower some of the personnel.

因此，在準備好的發言中，我們正在談論降低成本並試圖減少一些人員。

I'm just trying to understand, is the reduction in personnel anything to do with the Zylox-Tonbridge collaboration?

我只是想了解，人員的減少與 Zylox-Tonbridge 的合作有關嗎？

What I'm trying to ask is, if at all you lose any revenues by decreasing the force here, can you make that up more than that by the collaboration with Zylox?

我想問的是，如果你因為減少這裡的力量而損失了任何收入，你能透過與 Zylox 的合作來彌補嗎？

Thanks for the question, RK.

謝謝你的提問，RK。

So, first of all, the reduction in force, as we discussed, we reduced about 24% of our headcount, with headcount being our biggest operating expense in the actions we took in early June.

因此，首先，正如我們所討論的，減少兵力，我們減少了大約 24% 的員工人數，其中員工人數是我們 6 月初採取的行動中最大的營運支出。

None of that reduction was related to Zylox.

這些減少均與 Zylox 無關。

We did an assessment, as we talked about at the time, of where would our investment be required and where did the board and the company want to focus our investment in the second half of the year, with so many critical milestones and activities coming up related to our coronary program.

正如我們當時所討論的那樣，我們進行了評估，了解下半年需要我們的投資以及董事會和公司希望將我們的投資重​​點放在哪裡，因為有如此多的關鍵里程碑和活動即將到來與我們的冠狀動脈計劃有關。

And so, we took a step back in the peripheral business in terms of headcount, reducing about a third of the sales and marketing expense for that part of our organization.

因此，我們在外圍業務的人員數量方面後退了一步，減少了我們組織該部分約三分之一的銷售和行銷費用。

So, that's where the majority of reductions were.

所以，這就是大部分削減的地方。

We also made some other reductions across the operations, manufacturing group, and even in G&A, to run the company even leaner in these financial markets as we move forward.

我們還在營運、製造團隊甚至一般管理費用方面進行了一些其他削減，以便在我們前進的過程中在這些金融市場上更加精簡地經營公司。

We certainly are careful to maintain a full operating structure as a medical device manufacturer and marketer.

作為醫療器材製造商和行銷商，我們當然會謹慎地維持完整的營運結構。

We are maintaining a field presence in all of our existing territories, although a reduced presence in some territories.

我們在所有現有領土上維持實地存在，但在某些領土上的存在卻減少。

Where we did make reduction at the senior leadership level in sales, we've maintained two very experienced regional sales directors, one for the north and one for the south, to guide those activities.

在我們確實減少了銷售高級領導層的情況下，我們保留了兩名經驗豐富的區域銷售總監，一名負責北部，另一名負責南部，以指導這些活動。

So, none of this was related to Zylox.

所以，這一切都與 Zylox 無關。

We do believe that Zylox provides significant opportunity for us as they access a brand new market, a huge market with a very large sales and marketing infrastructure in place, both their own and distributors throughout the greater China region.

我們確實相信，Zylox 為我們提供了重要的機會，因為他們進入了一個全新的市場，一個擁有非常大的銷售和行銷基礎設施的巨大市場，包括他們自己的和整個大中華地區的經銷商。

We don't anticipate significant revenue from that until sometime well into 2025 as they get their regulatory approval.

我們預計要到 2025 年他們獲得監管部門的批准後才能從中獲得可觀的收入。

But we do think that will definitely provide upside to our total revenue base as they start to come online and sell the products.

但我們確實認為，隨著他們開始上線並銷售產品，這肯定會為我們的總收入基礎帶來上升空間。

The other thing that the Zylox transaction brings to us is while we are maintaining a full manufacturing capability here in the United States, is they are in the process of establishing and we're helping them establish their own manufacturing capability, not only for eventual supply to the China market, but under our agreements with Zylox, we have the opportunity to purchase product from them, finished goods on a cost plus basis, which could provide the opportunity for us to significantly reduce our cost of goods, improve our gross margins, and also reduce our overall operating our overhead expense.

Zylox 交易為我們帶來的另一件事是，雖然我們在美國保持完整的製造能力，但他們正在建立自己的製造能力，我們正在幫助他們建立自己的製造能力，而不僅僅是為了最終的供應到中國市場，但根據我們與Zylox 的協議，我們有機會以成本加成的方式從他們那裡購買產品、成品，這可以為我們提供大幅降低商品成本、提高毛利率的機會，並減少我們的整體營運管理費用。

So a lot of elements of this deal that could be very positive to us.

因此，這筆交易的許多要素對我們來說都是非常正面的。

We do expect in the back half of the year, because we have reduced our team, some softening of revenue on the peripheral side.

我們確實預計在今年下半年，因為我們減少了團隊，週邊地區的收入將會減弱。

But we think that's the right strategic decision as we focus resources on the very high opportunity coronary area and continue to support our Zylox relationship.

但我們認為這是正確的策略決策，因為我們將資源集中在機會非常大的冠狀動脈領域，並繼續支持我們的 Zylox 關係。

Okay, thanks for all the color.

好的，謝謝你的所有顏色。

On the Zylox relationship, when do you think Zylox will be able to start filing applications within the Chinese regulatory bodies so that you can get some product through the sales channels?

關於Zylox的關係，您認為Zylox什麼時候能夠開始向中國監管機構提交申請，以便您可以透過銷售管道獲得一些產品？

I know you said sometime in 2025, I did hear that, but I'm just trying to understand where things are as we speak.

我知道你說過 2025 年的某個時候，我確實聽到了，但我只是想了解我們說話時的情況。

Yeah, so there are really two primary activities that Zylox is leading and we're supporting them.

是的，Zylox 確實正在領導兩項主要活動，我們正在支持它們。

One is to prepare for regulatory registration of our products as imported products in China.

一是為我們的產品作為進口產品在中國進行監管註冊做好準備。

And as you're probably aware, China NMPA, which is the Chinese FDA, has very stringent and rigorous requirements.

您可能知道，中國 NMPA（即中國 FDA）有非常嚴格的要求。

And there's a complete battery of verification and validation testing that has to be done.

並且必須完成一系列完整的驗證和確認測試。

It's called type testing in China.

在中國這稱為型式試驗。

We're well along, or Zylox is well along in that process.

我們進展順利，或者 Zylox 在這個過程中進展順利。

And once that is completed, and they're also been performing a lot of work, again, with our support on preparing the appropriate documentation for regulatory filing.

一旦完成，他們也會在我們的支持下進行大量工作，為監管備案準備適當的文件。

So once that is completed, and we certainly don't want to speak for them on a timing basis, they would be in a position to file, we think, a very robust package with the NMPA, which would support the kind of timeframes that they've guided to, which is a 2025 potential launch.

因此，一旦完成，我們當然不想在時間上為他們說話，我們認為，他們將能夠向 NMPA 提交一個非常穩健的一攬子計劃，這將支持這樣的時間框架：他們預計將於 2025 年推出。

And I would expect that to be sometime in the second half of 2025.

我預計會在 2025 年下半年的某個時候。

But again, it's not something that we're in control of.

但同樣，這不是我們可以控制的。

And then on the Pantheris LV, the limited launch that you have right now, when can that get turned into a full commercial launch?

然後在 Pantheris LV 上，你們現在有限的發布，什麼時候可以變成全面的商業發布？

Yeah, so as you know, we've been in the market with the Pantheris LV product for a while now.

是的，如您所知，我們的 Pantheris LV 產品已經進入市場一段時間了。

We've had some wonderful case experience and learned a lot about the device, identified a couple of areas where we wanted to make some minor areas for improvement prior to commercial launch.

我們已經獲得了一些精彩的案例經驗，並了解了很多有關該設備的知識，確定了我們希望在商業發布之前進行一些小改進的幾個領域。

Those have all now been completed and released.

現在這些都已經完成並發布了。

And we're in the process of finalizing inventory bills for transition to full commercial launch, which we would expect to happen in the very near term.

我們正在最終確定庫存賬單，以過渡到全面商業發布，我們預計這將在不久的將來發生。

On the cardiovascular catheter, you said you're getting ready to file the IDE.

關於心血管導管，你說你準備提交IDE。

So let's say you file the IDE in the fourth quarter.

假設您在第四季提交了 IDE。

How long after that can you start the study?

多久之後可以開始學習？

And in terms of your initial conversations with potential clinics that can do the IDE for you, where do those conversations stand now?

就您與可以為您提供 IDE 的潛在診所進行的初步對話而言，這些對話現在處於什麼狀態？

Yeah, so first of all, to answer your first question, assuming filing of the IDE in the near term here, as we talked about, we would plan and assume, of course, out of our control, but typically, four to six months for IDE clearance, which would put us into the early part of 2025.

是的，首先，回答你的第一個問題，假設在短期內提交 IDE，正如我們所討論的，我們會計劃和假設，當然，這是我們無法控制的，但通常是四到六個月IDE許可，這將使我們進入2025 年初。

While we're waiting for IDE clearance, we would be contracting with and preparing for certainly the pilot part of our study where we would first go into five to ten patients and then the expansion into the full clinical study.

當我們等待 IDE 批准時，我們將與我們的研究的試點部分簽訂合約並為其做準備，我們將首先進入 5 到 10 名患者，然後擴展到完整的臨床研究。

We have already identified several clinical sites.

我們已經確定了幾個臨床地點。

We've been in discussion with those sites.

我們一直在與這些網站進行討論。

And our IDE filing will include the initial sites that we're planning on.

我們的 IDE 歸檔將包括我們計劃的初始​​網站。

So that's how far along we are in those discussions.

這就是我們討論的進展。

And I will say there's a lot of enthusiasm with the physicians, not only who have been involved with the development of this product as part of our advisory board, but also other physicians who've learned about it, who we've shared information with, and interest in participating in something that could be so really groundbreaking for this market.

我想說的是，醫生們非常熱情，不僅是作為我們顧問委員會的一部分參與該產品開發的醫生，還有其他了解該產品的醫生，我們與他們分享了信息，以及參與對這個市場來說可能具有真正開創性的事物的興趣。

As you know, RK, this is an extraordinarily challenging condition to treat.

如你所知，RK，這是一種非常難以治療的病症。

And it is no exaggeration to say that physicians will take four to five hours under fluoroscopy using many, many devices and accessory devices, and oftentimes not having a successful outcome.

毫不誇張地說，醫生需要使用很多很多設備和輔助設備進行透視檢查，花費四到五個小時，而且通常不會成功的結果。

And so if we can help these physicians make this more efficient, reduce the x-ray radiation, reduce the contrast media burden on the patient, and most of all, have a safe and successful crossing of that coronary CTO in a much less invasive fashion, I think we really can make a huge difference in the standard of care.

因此，如果我們能夠幫助這些醫生提高效率，減少 X 射線輻射，減輕患者的造影劑負擔，最重要的是，以侵入性更小的方式安全、成功地穿越冠狀動脈 CTO ，我認為我們確實可以在護理標準方面做出巨大的改變。

And I think physicians see that, too.

我認為醫生也看到了這一點。

So assuming that we file on the time frames we expect, assuming we get the clearance on the time frames we expect, I would assume that we would be in the in the first part of 2025, first half of 2025.

因此，假設我們在預期的時間範圍內提交文件，假設我們在預期的時間範圍內獲得許可，我會假設我們將在 2025 年上半年、2025 年上半年。

And while we are defining the number of patients required for our IDE filing, we do not see this as a large study in terms of number of patients required.

雖然我們正在定義 IDE 備案所需的患者數量，但就所需患者數量而言，我們並不認為這是一項大型研究。

And as we've discussed previously, there's only 30-day follow-up required for a CTO crossing device in the coronary arteries.

正如我們之前討論的，冠狀動脈中的 CTO 交叉裝置只需要 30 天的追蹤。

So we would hope that we could get the study enrolled in a relatively efficient time frame and be in a position to file a 510(K) based upon the clinical data in 2026.

因此，我們希望能夠在相對有效的時間範圍內完成這項研究，並能夠在 2026 年根據臨床數據提交 510(K)。

Those are the time frames that we're operating against.

這些是我們操作的時間框架。

And as I said, this has become a primary focus and certainly a priority of the company.

正如我所說，這已成為公司的主要關注點，當然也是優先事項。

Thank you.

謝謝。

Thanks for taking all my questions, Jeff.

謝謝你回答我所有的問題，傑夫。

Thank you, RK.

謝謝你，RK。

At this time, we have no further questions.

目前，我們沒有其他問題了。

I'll now turn the call back over to Mr. Jeff Soinski.

我現在將把電話轉回傑夫·索因斯基先生。

Well, thank you again for joining our call this afternoon.

好的，再次感謝您今天下午加入我們的電話會議。

We very much appreciate your interest in our company and look forward to reporting our further progress in the coming quarters.

我們非常感謝您對我們公司的興趣，並期待在未來幾季報告我們的進一步進展。

This concludes today's conference call.

今天的電話會議到此結束。

Thank you for attending.

感謝您的出席。