Avinger Inc (AVGR) 2018 Q4 法說會逐字稿

Greetings, and welcome to Avinger's 2018 Fourth Quarter and Full Year Conference Call.

問候，歡迎來到 Avinger 的 2018 年第四季度和全年電話會議。

(Operator Instructions) As a reminder, this conference is being recorded.

（操作員說明）提醒一下，正在錄製此會議。

(Operator Instructions)

（操作員說明）

It is now my pleasure to introduce Matt Kreps, Managing Director at Darrow Associates Investor Relations.

現在我很高興介紹 Darrow Associates Investor Relations 的董事總經理 Matt Kreps。

Mr. Kreps, you may begin.

Kreps 先生，您可以開始了。

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

謝謝你，凱文，感謝大家參加今天的電話會議。

I would like to welcome all of you to Avinger's Fourth Quarter and Full Year 2018 Conference Call.

歡迎大家參加 Avinger 2018 年第四季度和全年電話會議。

Joining us today are Avinger's CEO, Jeff Soinski; and Chief Financial Officer, Mark Weinswig.

今天加入我們的是 Avinger 的首席執行官 Jeff Soinski；和首席財務官 Mark Weinswig。

Earlier today, Avinger released its financial results for the fourth quarter and year ended December 31, 2018.

今天早些時候，Avinger 發布了截至 2018 年 12 月 31 日的第四季度和年度財務業績。

A copy of the release is posted on the Avinger website under Investor Relations.

該新聞稿的副本發佈在 Avinger 網站的投資者關係下。

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 the 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》的安全港條款作出的.

Any statements contained in this call that are 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不是歷史事實陳述的陳述都應被視為前瞻性陳述。

All forward-looking statements, including without limitation or future financial expectations, are based upon our current estimates and various assumptions.

所有前瞻性陳述，包括但不限於未來財務預期，均基於我們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存在重大差異。

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

因此，您不應過分依賴這些陳述。

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列表和描述，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，Avinger 不承擔更新或修改任何財務預測或前瞻性陳述的任何意圖或義務，無論是因為新信息、未來事件還是其他原因。

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

有了這個，我現在想把電話轉給傑夫。

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。

2018 was a year of significant progress for Avinger as we repositioned the company to focus on higher-margin disposables sales, drove growth in total cases and expanded our product line with truly innovative tools and the fight against peripheral artery disease.

2018 年是 Avinger 取得重大進展的一年，因為我們將公司重新定位為專注於利潤率更高的一次性用品銷售，推動了總案例的增長，並通過真正創新的工具和與外周動脈疾病的鬥爭擴展了我們的產品線。

These efforts culminated in the 510(k) clearance and launch of our Pantheris next-generation device, a major advancement in our technology.

這些努力最終使我們的 Pantheris 下一代設備獲得 510(k) 許可並上市，這是我們技術的重大進步。

We also secured CE Marking and submitted a 510(k) application to the FDA for Pantheris SV, which enables treatment of lesions in smaller diameter vessels.

我們還獲得了 CE 標誌，並向 FDA 提交了 Pantheris SV 的 510(k) 申請，它可以治療較小直徑血管中的病變。

We believe Pantheris SV has the potential to expand our available market by as much as 50%, which should allow us to address a significantly larger portion of the estimated $500 million atherectomy market.

我們相信 Pantheris SV 有可能將我們的可用市場擴大多達 50%，這應該使我們能夠解決估計價值 5 億美元的旋切術市場的更大部分。

We also made substantial progress on multiple post-market clinical study initiatives and made significant advances in redding our next-generation CTO crossing device, Ocellaris, for submission later in 2019.

我們還在多個上市後臨床研究計劃上取得了實質性進展，並在我們的下一代 CTO 交叉設備 Ocellaris 方面取得了重大進展，將於 2019 年晚些時候提交。

Importantly, we've achieved these goals while reducing operating expenses by more than 40% from 2017.

重要的是，我們已經實現了這些目標，同時與 2017 年相比運營費用減少了 40% 以上。

This was a difficult but necessary process, and we've come through leaner, stronger and more focused as an organization.

這是一個艱難但必要的過程，作為一個組織，我們經歷了更精簡、更強大、更專注的過程。

This was evidenced by multiple key milestones achieved during the fourth quarter in both our commercial and clinical programs.

第四季度在我們的商業和臨床項目中取得的多個關鍵里程碑證明了這一點。

These include quickly ramping Pantheris next-gen utilization to over 500 cases, the successful completion of our first Pantheris SV cases in Europe, strengthening our balance sheet with an $11.5 million public offering that brought in over $10 million of net proceeds, and the release of preliminary results from our SCAN clinical study which indicated that OCT imaging with Pantheris was statistically superior or equivalent to IVUS on all parameters evaluated as a diagnostic imaging tool in the peripheral arteries.

其中包括迅速將 Pantheris 下一代利用率提高到 500 多個案例，成功完成我們在歐洲的第一個 Pantheris SV 案例，通過 1150 萬美元的公開募股加強我們的資產負債表，帶來超過 1000 萬美元的淨收益，以及發布我們的 SCAN 臨床研究的初步結果表明，在作為外周動脈診斷成像工具評估的所有參數上，Pantheris 的 OCT 成像在統計學上優於或等同於 IVUS。

Perhaps most importantly, feedback from the physicians across these excerpts has been very positive.

也許最重要的是，醫生對這些摘錄的反饋非常積極。

Our real time intravascular imaging platform enables the interventionalist to not only affect highly targeted treatment, but also to confirm in real time that he or she has treated the disease while avoiding damage to vessel walls.

我們的實時血管內成像平台使介入醫生不僅可以影響高度針對性的治療，還可以實時確認他或她已經治療了疾病，同時避免損傷血管壁。

Such damage often leads to high rates of disease recurrence or restenosis with competing methodologies.

這種損傷通常導致疾病復發率高或與競爭方法再狹窄。

Recurrence that are clinical studies in real-world clinical experience sure can be reduced with our proprietary Lumivascular approach.

我們專有的 Lumivascular 方法肯定可以減少真實世界臨床經驗中臨床研究的複發。

This distinction truly differentiates Avinger from any other treatment modality.

這種區別真正將 Avinger 與任何其他治療方式區分開來。

At this point, let me recap a few key developments on each of our platforms, starting with next-generation Pantheris, the first and only image-guided atherectomy system for the treatment of peripheral artery disease.

在這一點上，讓我回顧一下我們每個平台的一些關鍵發展，從下一代 Pantheris 開始，這是第一個也是唯一一個用於治療外周動脈疾病的圖像引導斑塊切除術系統。

As you may recall, we received 510(k) clearance for this significantly improved system in May 2018.

您可能還記得，我們在 2018 年 5 月收到了這個經過顯著改進的系統的 510(k) 許可。

In September, we treated our 200th patient across 35 accounts.

9 月，我們治療了 35 個賬戶中的第 200 名患者。

In December, we announced treatment of our 500th patient across 65 accounts.

12 月，我們宣布對 65 個賬戶中的第 500 名患者進行治療。

The next-gen device is performing extremely well on quality, reliability, and most importantly, clinical results with our positioned customers.

下一代設備在質量、可靠性以及最重要的是我們定位客戶的臨床結果方面表現非常出色。

Pantheris next-gen sales continue to be a primary driver of our success, with Pantheris revenue rising 18% sequentially and breaking the $1 million mark in the fourth quarter.

Pantheris 的下一代銷售繼續成為我們成功的主要推動力，Pantheris 收入環比增長 18%，並在第四季度突破 100 萬美元大關。

As we look to 2019, our sales team remains focused on driving utilization in existing accounts and building a pipeline of high-potential new accounts for further expansion.

展望 2019 年，我們的銷售團隊仍然專注於推動現有客戶的利用率，並建立高潛力新客戶渠道以進一步擴張。

We added 2 salespeople to our organization in the fourth quarter and anticipate continuing to expand our sales team on a measured basis in 2019, with a target of ending the year with approximately 30 sales professionals.

我們在第四季度為我們的組織增加了 2 名銷售人員，並預計在 2019 年繼續有節制地擴大我們的銷售團隊，目標是在年底擁有約 30 名銷售專業人員。

We believe the strategic investment in our sales force will be an important contributor to our growth as we continue to ramp utilization, increase our focus on opening new user sites and expand our presence in regions of the country with high incidence of PAD.

我們相信，隨著我們繼續提高利用率、更加註重開設新用戶站點以及擴大我們在 PAD 高發地區的業務，對我們銷售隊伍的戰略投資將對我們的增長做出重要貢獻。

Turning to Pantheris SV or small vessel, we submitted a 510(k) application for this important new device to the U.S. Food and Drug Administration in August.

轉向 Pantheris SV 或小型容器，我們於 8 月向美國食品和藥物管理局提交了針對這一重要新設備的 510(k) 申請。

Pantheris SV offers a lower profile and longer length intended to expand the number of addressable procedures for our platform.

Pantheris SV 提供更小的輪廓和更長的長度，旨在擴大我們平台的可尋址程序的數量。

It incorporates key improvements from the next-generation Pantheris system plus additional modifications to simplify treatment of small vessel disease.

它結合了下一代 Pantheris 系統的關鍵改進以及其他改進，以簡化小血管疾病的治療。

We have answered all open questions and submitted all additional data requested as part of the FDA review process, and hope to have a good news to share with you soon.

作為 FDA 審查過程的一部分，我們已經回答了所有懸而未決的問題並提交了所有要求的額外數據，並希望盡快有好消息與您分享。

As with the next-generation Pantheris, following U.S. 510(k) clearance, we plan to first introduce Pantheris SV into a limited number of U.S. sites prior to national launch to our installed base of accounts.

與下一代 Pantheris 一樣，在獲得美國 510(k) 許可後，我們計劃先將 Pantheris SV 引入有限數量的美國站點，然後再在全國范圍內投放到我們已安裝的客戶群中。

We've begun internal preparations for this limited launch process, which we expect to occur in the second quarter of this year.

我們已經開始為這個有限的發布過程進行內部準備，預計將在今年第二季度進行。

As mentioned earlier, we received CE Marking for Pantheris SV in October 2018, which allowed us to perform our first clinical cases in Europe beginning in December of last year.

如前所述，我們於 2018 年 10 月獲得了 Pantheris SV 的 CE 標誌，這使我們能夠從去年 12 月開始在歐洲開展首個臨床病例。

We're excited about the early clinical outcomes that physicians have achieved with the new device.

我們對醫生使用新設備取得的早期臨床結果感到興奮。

And in January of this year, Dr. Arne Schwindt, a vascular surgeon, at St.

今年 1 月，血管外科醫生 Arne Schwindt 博士在 St.

Franziskus Hospital in Muenster, Germany performed highly successful live case with Pantheris SV for transmission at LINC 2019, one of the top clinical conferences in the field of vascular medicine.

德國明斯特的 Franziskus 醫院在血管醫學領域頂級臨床會議之一的 LINC 2019 上進行了非常成功的 Pantheris SV 傳播活體病例。

Based on this early experience, we're even more excited about the potential for Pantheris SV to improve the standard of care for patients with small vessel disease and drive growth of our business.

基於這一早期經驗，我們對 Pantheris SV 提高小血管病患者護理標準並推動我們業務增長的潛力感到更加興奮。

Turning to our CTO crossing products, we continue to make progress in the development of our next-generation devices.

談到我們的 CTO 交叉產品，我們在開發下一代設備方面繼續取得進展。

CTO stands for chronic total occlusion or a completely blocked artery.

CTO 代表慢性完全閉塞或完全阻塞的動脈。

This is a severe form of PAD, necessitating the treating physician to create a passage through the blockage so that a guidewire can be introduced to facilitate further treatment.

這是一種嚴重的外周動脈疾病，需要主治醫生在阻塞處開闢一條通道，以便引入導絲以促進進一步治療。

Our Ocelot family of catheters are the first and only image-guided CTO crossing devices available on the market.

我們的 Ocelot 導管系列是市場上第一個也是唯一一個圖像引導的 CTO 穿越設備。

The Ocelot catheters are extremely reliable with strong clinical data and excellent real-world results.

Ocelot 導管非常可靠，具有強大的臨床數據和出色的真實世界結果。

We see the opportunity to expand our presence in the CTO crossing market with the development and introduction of Ocellaris, our next-generation system.

我們看到了通過開發和推出我們的下一代系統 Ocellaris 來擴大我們在 CTO 交叉市場的存在的機會。

Ocellaris will leverage real-time high-definition OCT imaging and incorporates a number of other advances, such as the ability to spin at speeds up to 1,000 rpm in a steerable tip for precise maneuverability.

Ocellaris 將利用實時高清 OCT 成像並結合許多其他進步，例如能夠在可操縱的尖端以高達 1,000 rpm 的速度旋轉以實現精確的機動性。

We believe these improvements will further our competitive advantage for the treatment of CTOs.

我們相信這些改進將進一步提升我們在 CTO 治療方面的競爭優勢。

While our near-term product priority is final commercialization and U.S. launch of Pantheris SV, we anticipate making significant progress in the development and commercialization of Ocellaris in 2019.

雖然我們近期的產品重點是 Pantheris SV 的最終商業化和美國上市，但我們預計 2019 年 Ocellaris 的開發和商業化將取得重大進展。

Our current strategy is to pursue CE Marking for commercialization of Ocellaris in the European Union and other CE Mark countries in the third quarter of 2019.

我們目前的戰略是在 2019 年第三季度在歐盟和其他 CE 標誌國家尋求 CE 標誌以實現 Ocellaris 的商業化。

Following our initial Case experience in Europe, we anticipate submitting a 510(k) application of the U.S. FDA in the second half of 2019 for the use of Ocellaris in the peripheral arteries.

根據我們在歐洲的初步案例經驗，我們預計將在 2019 年下半年向美國 FDA 提交一份關於在外周動脈中使用 Ocellaris 的 510(k) 申請。

In addition, we believe the Ocellaris platform will provide a strong foundation for the development of proprietary image-guided CTO crossing devices for total blockages in the coronary arteries, which are a driver of highly invasive coronary bypass surgery and which we believe represents a substantial unmet need in the medical community.

此外，我們相信 Ocellaris 平台將為開發專有的圖像引導 CTO 穿越設備提供堅實的基礎，以解決冠狀動脈的完全阻塞，這是高侵入性冠狀動脈搭橋手術的驅動力，我們認為這代表了一個巨大的未滿足醫學界的需要。

We've also made exciting progress in our clinical study programs.

我們的臨床研究項目也取得了令人振奮的進展。

In December, we announced preliminary data analysis from the SCAN clinical study, which indicated that OCT imaging with Pantheris was statistically superior or equivalent to intravascular ultrasound or IVUS on all parameters evaluated as a diagnostic imaging tool in the peripheral arteries.

去年 12 月，我們公佈了 SCAN 臨床研究的初步數據分析，表明在作為外周動脈診斷成像工具評估的所有參數上，Pantheris 的 OCT 成像在統計學上優於或等同於血管內超聲或 IVUS。

The study's physician investigators have now submitted a manuscript with final results to a peer-review journal, and we anticipate publication in 2019.

該研究的醫師研究人員現已向同行評審期刊提交了一份包含最終結果的手稿，我們預計將於 2019 年發表。

We believe the study is an important step forward in building a body of evidence to pursue incremental reimbursement for the diagnostic imaging capabilities of our OCT image-guided catheters in the peripheral arteries, similar to the reimbursement currently provided for IVUS.

我們認為，這項研究是在建立大量證據方面向前邁出的重要一步，以尋求對我們外周動脈中 OCT 圖像引導導管的診斷成像能力進行增量報銷，類似於目前為 IVUS 提供的報銷。

In addition, we continue to enroll patients in our INSIGHT IDE clinical trial.

此外，我們繼續在我們的 INSIGHT IDE 臨床試驗中招募患者。

INSIGHT is a multicenter clinical study designed to evaluate the safety and effectiveness of Pantheris for treating in-stent restenosis or ISR in lower extremity arteries.

INSIGHT 是一項多中心臨床研究，旨在評估 Pantheris 治療下肢動脈支架內再狹窄或 ISR 的安全性和有效性。

We now have 16 sites open for enrollment, including 2 new German sites, which have already begun enrolling patients.

我們現在有 16 個站點開放註冊，包括 2 個新的德國站點，它們已經開始招募患者。

We're encouraged by the early results of the study and anticipate that one of the physician investigators in the study will present an interim analysis of the first patients treated in the study at a clinical conference later this year.

我們對這項研究的早期結果感到鼓舞，並預計該研究中的一名醫師研究人員將在今年晚些時候的臨床會議上對第一批接受該研究治療的患者進行中期分析。

We believe that a specific indication for the treatment of ISR would be an important label expansion for Pantheris, and once the IDE study is completed, we plan on filing a 510(k) application with the FDA to pursue this claim.

我們認為，治療 ISR 的具體適應症將是 Pantheris 的重要標籤擴展，一旦 IDE 研究完成，我們計劃向 FDA 提交 510(k) 申請以追究這一要求。

Before turning the call over to Mark to discuss the financial results, I want to reiterate the 5 strategic goals that will form the pillars of our growth strategy in 2019 and forward.

在將電話轉給馬克討論財務業績之前，我想重申 5 個戰略目標，它們將構成我們 2019 年及未來增長戰略的支柱。

These include: driving utilization at current sites and in current markets, launching new sites in underserved areas with high rates of PAD, launching new devices to expand our addressable market and revenue per site opportunity, continuing to produce compelling clinical data confirming the unique benefits of Avinger's Lumivascular platform, and maintaining a lean operating structure as we scale the business.

其中包括：推動當前站點和當前市場的利用率，在 PAD 率高的服務欠缺地區啟動新站點，啟動新設備以擴大我們的目標市場和每個站點的收入機會，繼續產生令人信服的臨床數據，確認Avinger 的 Lumivascular 平台，並在我們擴展業務時保持精益運營結構。

We look forward to reporting our progress on these initiatives in the coming quarters.

我們期待在未來幾個季度報告我們在這些舉措方面的進展。

With that, I'd like to now turn the call over to Mark.

有了這個，我現在想把電話轉給馬克。

Thank you, Jeff.

謝謝你，傑夫。

Total revenue was $2 million for the fourth quarter ended December 31, 2018, relatively flat with the third quarter.

截至 2018 年 12 月 31 日的第四季度總收入為 200 萬美元，與第三季度持平。

Revenue from disposable devices was $1.7 million for the fourth quarter, higher than the third quarter of 2018.

第四季度一次性設備收入為 170 萬美元，高於 2018 年第三季度。

Revenue related to Lightbox imaging consoles and other products was $0.3 million, down from the prior quarter, as our commercial sales focus continues to evolve to supporting catheter utilization in our most productive territories.

與 Lightbox 成像控制台和其他產品相關的收入為 30 萬美元，低於上一季度，因為我們的商業銷售重點繼續發展為支持我們最富有成效的地區的導管使用。

Gross margin for the fourth quarter of 2018 was 28%.

2018 年第四季度的毛利率為 28%。

Over the past year, we have significantly increased our gross margins due to reductions in excess in obsolescence charges, lower cost of quality-related expenses and lower operating expenses.

在過去的一年裡，由於過時費用的減少、質量相關費用的降低和運營費用的降低，我們的毛利率顯著增加。

We continue to believe that there are significant opportunities to increase our gross margins as we grow our revenues.

我們仍然相信，隨著我們收入的增長，我們有很大的機會來提高我們的毛利率。

Operating expenses for the fourth quarter were $6.4 million compared to $5.7 million in the prior quarter.

第四季度的運營費用為 640 萬美元，上一季度為 570 萬美元。

As we mentioned last quarter, we expect our sales and marketing expenses to increase in future periods as we invest in expanding our direct sales team in key territories to drive revenue growth.

正如我們上個季度提到的那樣，我們預計我們的銷售和營銷費用在未來期間會增加，因為我們投資擴大我們在關鍵地區的直銷團隊以推動收入增長。

The success of our next-generation Pantheris and the upcoming launch of our Pantheris SV product provides us with a great opportunity to reengage with existing customers to increase utilization and develop new accounts for our Lumivascular technology.

我們下一代 Pantheris 的成功和我們即將推出的 Pantheris SV 產品為我們提供了一個很好的機會來重新與現有客戶接觸，以提高利用率並為我們的 Lumivascular 技術開發新客戶。

Loss from operations for the fourth quarter of 2018 was $5.8 million compared to $5.1 million for the prior quarter, and net loss attributable to common stockholders for the fourth quarter of 2018 was $6.9 million.

2018 年第四季度的運營虧損為 580 萬美元，上一季度為 510 萬美元，2018 年第四季度歸屬於普通股股東的淨虧損為 690 萬美元。

Adjusted EBITDA, which is a non-GAAP measure that excludes excess and obsolete inventory reserves, restructuring and severance, stock compensation, depreciation and amortization and other items, as noted in the tables in today's press release, was a loss of $4.2 million for the fourth quarter of 2018 compared to a loss of $4.1 million in the preceding quarter.

調整後的 EBITDA 是一項非 GAAP 衡量指標，不包括過剩和過時的庫存儲備、重組和遣散費、股票補償、折舊和攤銷以及其他項目，如今天新聞稿中的表格所述，是 420 萬美元的虧損2018 年第四季度相比上一季度虧損 410 萬美元。

Over the past year, we have made significant progress in controlling costs and lowering our overall cost structure.

在過去的一年裡，我們在控製成本和降低整體成本結構方面取得了重大進展。

With the successful launch of our next-generation Pantheris device, we are making some investments in our sales and marketing functions to grow our business, which may slightly increase our operating expenses over the next 1 to 2 quarters.

隨著我們下一代 Pantheris 設備的成功推出，我們正在對我們的銷售和營銷職能進行一些投資以發展我們的業務，這可能會在未來 1 到 2 個季度略微增加我們的運營費用。

In addition, we are investing in expanding our clinical data to improve our competitive position in our -- in the marketplace.

此外，我們正在投資擴大我們的臨床數據，以提高我們在市場上的競爭地位。

Cash and cash equivalents totaled $16.4 million as of December 31, 2018.

截至 2018 年 12 月 31 日，現金和現金等價物總計 1640 萬美元。

This includes the net proceeds of approximately $10.2 million that we raised in November 2018 as part of the sale of common and preferred stock with warrants.

這包括我們在 2018 年 11 月籌集的約 1020 萬美元的淨收益，作為出售帶有認股權證的普通股和優先股的一部分。

As of December 31, 2018, there were approximately 34.9 million shares of common stock, 41,800 shares of preferred Series A stock, 1,701 shares of Series B preferred stock and 2,170 shares of Series C preferred stock outstanding.

截至 2018 年 12 月 31 日，已發行約 3490 萬股普通股、41,800 股 A 系列優先股、1,701 股 B 系列優先股和 2,170 股 C 系列優先股。

Each share of Series B and Series C preferred stock is convertible into 2,500 shares of the company's common stock at a conversion price of $0.40.

B 系列和 C 系列優先股每股可轉換為 2,500 股公司普通股，轉換價格為 0.40 美元。

Assuming conversion of all outstanding shares of Series B and Series C preferred stock at the current conversion price, the company would have approximately 44.6 million shares of common stock outstanding at December 31, 2018, excluding outstanding warrants and the Series A preferred stock, which is not presently convertible.

假設以當前轉換價格轉換 B 系列和 C 系列優先股的所有已發行股票，截至 2018 年 12 月 31 日，公司將擁有約 4460 萬股已發行普通股，不包括已發行認股權證和 A 系列優先股，即目前不可兌換。

At this point, I'd like to turn the call back to Jeff.

在這一點上，我想把電話轉回傑夫。

Thank you, Mark.

謝謝你，馬克。

We're pleased with the progress we made in 2018 and the achievement of several important milestones in the fourth quarter.

我們對 2018 年取得的進展以及第四季度幾個重要里程碑的實現感到高興。

We're thrilled with the performance of our next-generation Pantheris in clinical settings as we scale case volumes and are excited for the addition of Pantheris SV, which we believe will drive additional cases and increase revenue generated from our clinical sites.

隨著我們擴大病例數量，我們對下一代 Pantheris 在臨床環境中的表現感到興奮，並對 Pantheris SV 的加入感到興奮，我們相信這將推動更多病例並增加我們臨床站點產生的收入。

We look forward to executing against our growth targets in 2019 and continuing to report our progress in the quarters ahead.

我們期待在 2019 年實現我們的增長目標，並繼續報告我們在未來幾個季度的進展。

With that, we'll be happy to take your questions.

這樣，我們很樂意回答您的問題。

(Operator Instructions) Our first question today is coming from Jeffrey Cohen from Ladenburg Thalmann.

（操作員說明）我們今天的第一個問題來自 Ladenburg Thalmann 的 Jeffrey Cohen。

So -- sorry, I'm just going to jump around a number of questions.

所以 - 抱歉，我只想跳過一些問題。

So as far as the SV usage you'd suddenly experienced thus far, you spoke about that when you talked about some submittal here in August.

到目前為止，就您突然經歷的 SV 使用而言，您在 8 月份在這裡談到一些提交時談到了這一點。

Can you talk about that specifically as far as iterations and questions in the -- was that a Q2 limited launch?

你能具體談談迭代和問題嗎？那是第二季度的限量發布嗎？

What you spoke about?

你說什麼？

Can you review that, please, for us?

你能幫我們回顧一下嗎？

Certainly.

當然。

Yes, Jeff, we submitted in the U.S. to the U.S. FDA our 510(k) application in late August 2018.

是的，Jeff，我們於 2018 年 8 月下旬在美國向美國 FDA 提交了我們的 510(k) 申請。

As you know, the FDA has an interactive process where several questions were asked and answered and discussions that occurred that did lead to a formal request for additional information in the fourth quarter.

如您所知，FDA 有一個互動過程，其中提出並回答了幾個問題，並進行了討論，這些討論確實導致在第四季度正式要求提供更多信息。

We have now answered all of the questions that were answered or were asked by FDA as well as provided some additional data in response to those questions.

我們現在已經回答了 FDA 回答或提出的所有問題，並提供了一些額外的數據來回答這些問題。

So right now, the ball is in FDA's court.

所以現在，球在 FDA 的法庭上。

We feel, based on past experience and based on the nature of the questions, that we're moving towards the end of the process.

我們認為，根據過去的經驗和問題的性質，我們正在接近流程的尾聲。

But clearly, we can't anticipate at a fine point when that will happen.

但很明顯，我們無法準確預測這種情況何時會發生。

We are -- our plan is to proceed similarly to how we launch next-gen Pantheris where we first launch once we get the FDA clearance into a limited number of sites in the U.S., just again as one final check and confirmation that everything is operating the way we intend to, following that initial experience, which also helps us get our sales and marketing programs checked out prior to broader launch.

我們是 - 我們的計劃是與我們推出下一代 Pantheris 的方式類似，一旦我們獲得 FDA 許可進入美國有限數量的地點，我們將首次推出，再次作為最終檢查和確認一切正常根據最初的經驗，我們打算採用的方式也有助於我們在更廣泛的發布之前檢查我們的銷售和營銷計劃。

We do expect to launch more broadly to our entire installed base.

我們確實希望更廣泛地向我們的整個安裝基礎推出。

So where we are right now is we're waiting and hopeful that we're near the end of the FDA approval process.

因此，我們現在所處的位置是我們正在等待並希望我們接近 FDA 批准程序的尾聲。

Once we get that process or that approval, we will again launch this device into a limited set of accounts.

一旦我們獲得該流程或批准，我們將再次將此設備發佈到一組有限的帳戶中。

And then following that, and as we did with Pantheris next-gen, not terribly long after, look at expanding our full base.

然後緊隨其後，就像我們對 Pantheris 下一代所做的那樣，不久之後，看看擴大我們的整個基地。

So our plans and what we're working towards is a second quarter launch of Pantheris SV.

所以我們的計劃和我們正在努力的是第二季度推出 Pantheris SV。

But again, the caveat, the timing isn't fully in our control.

但再次提醒，時機並不完全在我們的控制之中。

Okay.

好的。

So no questions back after your submittal of last iteration at the end of the year.

因此，在您年底提交最後一次迭代後，沒有任何問題。

So presumably you could be on this 100-plus day clock for an approval.

所以大概你可以在這個 100 多天的時鐘上獲得批准。

Once -- the timing is really more predicated on initial response to your initial filing so -- and every case is unique, right?

一次 - 時間實際上更多地取決於對您最初提交的初步回應 - 每個案例都是獨一無二的，對吧？

But right now, we have no open questions, no open request for data.

但是現在，我們沒有公開的問題，也沒有公開的數據請求。

And we are feeling, based on past experience, that we're getting near to the end of the process.

根據過去的經驗，我們感覺這個過程即將結束。

Okay, got it.

好，知道了。

And then on Ocellaris, you spoke about the CE Marking in the third quarter and that you would be -- is this correct you'd be submitting FDA data or you'd be filing in the back half for peripherals?

然後在 Ocellaris 上，你在第三季度談到了 CE 標誌，你會 - 這是正確的你會提交 FDA 數據還是你會在後半部分提交外圍設備？

Our anticipation is that we would be filing in the back half of the year.

我們預計我們將在今年下半年提交申請。

We do look forward to the opportunity as we have done with past products to get that early clinical experience in Europe under CE Mark, which typically has a shorter time frame.

我們確實期待有機會像我們對過去的產品所做的那樣，在歐洲獲得 CE 標誌下的早期臨床經驗，這通常具有更短的時間框架。

And that is our plan.

這就是我們的計劃。

We are very pleased with how the product development is going on Ocellaris.

我們對 Ocellaris 的產品開發進展情況感到非常滿意。

We've had substantial feedback from our KOLs and key physicians and feel like we are going to have a marked improvement in terms of capability to treat a variety of CTOs with important new capabilities in that product a little different than next-gen Pantheris.

我們從我們的 KOL 和主要醫生那裡得到了大量反饋，並且感覺我們將在治療各種 CTO 的能力方面有顯著改善，該產品具有與下一代 Pantheris 略有不同的重要新功能。

We don't see it as a replacement for Ocelot product, which currently has the best data available for a CTO crossing in the peripheral arteries.

我們不認為它是 Ocelot 產品的替代品，Ocelot 目前擁有可用於外周動脈 CTO 交叉的最佳數據。

We see it as an additional product that will help us expand that franchise with a highly differentiated end device with new capability.

我們將其視為一種附加產品，將幫助我們通過具有新功能的高度差異化的終端設備擴展該特許經營權。

We also are very excited about Ocellaris because as we've discussed previously, we see that as the -- that technology platform as our foundation to develop products for treating coronary CTOs, which is a very poorly met need right now from an endovascular percutaneous basis.

我們也對 Ocellaris 感到非常興奮，因為正如我們之前所討論的那樣，我們將其視為 - 該技術平台是我們開發治療冠狀動脈 CTO 產品的基礎，目前從血管內經皮基礎來看，這是一個非常難以滿足的需求.

So a lot of capability beyond even the peripheral product that we intend to file this year.

因此，許多功能甚至超出了我們今年打算提交的外圍產品。

Okay, got it.

好，知道了。

And then you spoke about, I mean, too on the commercial force in the fourth quarter getting to 30 at the end of the '19.

然後你談到，我的意思是，在 19 年底第四季度的商業力量也達到了 30。

Where is that number now?

那個號碼現在在哪裡？

So we are -- so we ended the year at 22 people in our sales organization.

所以我們 - 所以我們在銷售組織中以 22 人結束了這一年。

And Jeff, what we had said is for us, it's most important to hire the right people to hire at a pace so we can train them properly and bring them up to speed.

傑夫，我們所說的對我們來說，最重要的是僱用合適的人以按節奏僱用，這樣我們就可以適當地培訓他們並讓他們跟上速度。

And we are tracking, I think, well against that.

我認為，我們正在跟踪這一點。

I'm very pleased with the sales management and the care and diligence that they're putting into the hiring process, and we are able to track some really strong talent.

我對銷售管理以及他們在招聘過程中所投入的關心和勤奮感到非常滿意，我們能夠追踪到一些非常優秀的人才。

Okay, got it.

好，知道了。

And then as far as the sites for ISR, you said you'll have some preliminary data in the back half of the year.

然後就 ISR 站點而言，您說您將在今年下半年獲得一些初步數據。

So what does filing look like as far as timing?

那麼，就時間而言，歸檔是什麼樣子的呢？

So first of all, one of the things that you'll typically see in clinical studies, and these are open label, these are not blinded, of course, studies in any way, is the opportunity once you get more than -- typically more than 30 patients to take an early look at data and present that data at clinical conferences.

所以首先，你通常會在臨床研究中看到的一件事，這些是開放標籤，這些不是盲目的，當然，以任何方式進行的研究，一旦你獲得超過 - 通常更多的機會超過 30 名患者早期查看數據並在臨床會議上展示該數據。

And one of the lead physician investigators in that study has indicated an interest to do that.

該研究中的一位首席醫師研究人員表示有興趣這樣做。

So we're hopeful that we'll be in a position to have that data, that early data presented at a major clinical conference this year.

所以我們希望我們能夠獲得這些數據，這些早期數據在今年的一次主要臨床會議上提出。

The enrollment, I think, as we talked about in our last call is going just a little slower than we anticipated originally.

我認為，正如我們在上次電話會議中談到的那樣，註冊進度比我們最初預期的要慢一點。

But now with the addition of new sites, including these 2 new German sites, it's picked up.

但是現在隨著新站點的添加，包括這兩個新的德國站點，它被選中了。

We believe that enrollment will be completed in 2020 for that study.

我們相信該研究的註冊將於 2020 年完成。

So we anticipate a 2020 time frame for filing of the 510(k) once the 6-month follow-up period has been completed for all patients enrolled in the study.

因此，我們預計一旦所有參與研究的患者完成 6 個月的隨訪期，就可以在 2020 年提交 510(k)。

Okay.

好的。

And then lastly, just walk us through how coding may play out for Pantheris as far as IVUS coding goes and then move back.

最後，就 IVUS 編碼而言，向我們介紹編碼如何為 Pantheris 發揮作用，然後再返回。

So we -- as you know, in the fourth quarter, we released the initial results or the preliminary results from the SCAN study.

所以我們 - 如您所知，在第四季度，我們發布了 SCAN 研究的初步結果或初步結果。

We now have the final results in place.

我們現在有了最終結果。

SCAN was a study that was done, A, for the purposes of just reinforcing and proving the benefits of our OCT imaging in the peripheral arteries as diagnostic tools compared to IVUS, there really hasn't been a study done like that in the U.S. There have been studies ex U.S. And that study shows that we were either superior or equivalent to IVUS on all parameters evaluated.

SCAN 是一項已完成的研究，A，其目的只是為了加強和證明我們的外周動脈 OCT 成像作為診斷工具與 IVUS 相比的優勢，在美國確實沒有進行過這樣的研究。在美國進行過研究，該研究表明我們在所有評估參數上優於或等同於 IVUS。

So very pleased with the results.

對結果非常滿意。

That's now been submitted for publication, and we see that study as an important support for a CPT code application that we would file -- anticipate filing this year so that we could pursue incremental reimbursement for both Ocelot and Pantheris for diagnostic imaging in the peripheral arteries, similar to what IVUS has and -- which is about $1,500 a case in the OBL setting or the office-based lab.

現在已經提交出版，我們認為該研究是對我們將提交的 CPT 代碼申請的重要支持——預計今年提交，以便我們可以為 Ocelot 和 Pantheris 的外周動脈診斷成像尋求增量報銷，類似於 IVUS 所擁有的——在 OBL 環境或基於辦公室的實驗室中，每箱約 1,500 美元。

And we do have, as you might remember, OCD.

你可能還記得，我們確實有強迫症。

Diagnostic claims cleared in separate 10-Ks for both Ocelot and Pantheris by FDA, but that doesn't automatically lead to reimbursement.

FDA 在單獨的 10-Ks 中為 Ocelot 和 Pantheris 清除了診斷索賠，但這不會自動導致報銷。

So we're going to that process, and certainly we don't control that process in any way.

因此，我們將進入該流程，當然我們不會以任何方式控制該流程。

The next big step is to file the CPT code application and then work forward.

下一步是提交 CPT 代碼申請，然後繼續前進。

The time frame that we're on and just kind of the cycle of how this works from application through -- and moving through the process is that if we are successful in gaining that incremental reimbursement, we would know in 2020, and then it would go effective in January 2021 but, again, a lot out of our control there, but we're thrilled with the data as it relates to the ability to support that application.

我們所處的時間框架以及從申請到整個流程的工作方式的循環是，如果我們成功獲得增量報銷，我們將在 2020 年知道，然後它會將於 2021 年 1 月生效，但同樣，我們無法控制很多，但我們對數據感到興奮，因為它與支持該應用程序的能力有關。

We have reached the end of our question-and-answer session.

我們的問答環節已經結束。

I'd like to turn the floor back over to Jeff for any further or closing comments.

我想將發言權轉回 Jeff 以徵求任何進一步意見或結束意見。

Well, thank you very much for joining our call this afternoon.

非常感謝您今天下午加入我們的電話會議。

We appreciate your interest in our company, and look forward to updating you on our progress when we report our first quarter results.

我們感謝您對我們公司的興趣，並期待在我們報告第一季度業績時向您通報我們的最新進展。

We'll also be presenting at the Oppenheimer Annual Healthcare Conference on March 20, and hope to see some of you there.

我們還將在 3 月 20 日的 Oppenheimer 年度醫療保健會議上發表演講，並希望能在那裡見到你們中的一些人。

Thank you very much.

非常感謝。

That does conclude today's teleconference.

今天的電話會議到此結束。

You may disconnect your line at this time, and have a wonderful day.

您可以在此時斷開您的線路，並度過美好的一天。

We thank you for your participation today.

感謝您今天的參與。