Avinger Inc (AVGR) 2017 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Q4 2017 Avinger, Inc.

女士們先生們，美好的一天，歡迎來到 Avinger, Inc. 2017 年第四季度。

Earnings Conference Call.

收益電話會議。

(Operator Instructions) As a reminder, this conference call may be recorded for replay purposes.

（操作員說明）提醒一下，此電話會議可能會被錄音以供重播。

It is now my pleasure to hand the conference over to Ms. Caroline Corner of Westwicke Partners.

現在我很高興將會議交給 Westwicke Partners 的 Caroline Corner 女士。

Ma'am, you may begin.

女士，您可以開始了。

Thank you, and thank you all for participating in today's call.

謝謝大家，也感謝大家參加今天的電話會議。

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

今天加入我們的是 Avinger 的首席執行官 Jeff Soinski；和首席財務官馬特·弗格森 (Matt Ferguson)。

Earlier today, Avinger released financial results for the full year and fourth quarter ended December 31, 2017.

今天早些時候，Avinger 發布了截至 2017 年 12 月 31 日的全年和第四季度的財務業績。

Before we begin, I'd 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，這些聲明是根據美國私人證券訴訟改革法案的安全港條款作出的1995.

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 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文件。

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。

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

我現在想把電話轉給傑夫。

Thanks, Caroline.

謝謝，卡羅琳。

Good afternoon, and thank you all for joining us.

下午好，感謝大家加入我們。

Avinger's had a -- has achieved a great deal in recent months, and we appreciate the opportunity to provide you with today's update.

Avinger 在最近幾個月取得了很大成就，我們很高興有機會為您提供今天的更新。

As Matt will detail shortly, we recently completed a series of financial transactions that have put us in a much stronger financial position.

正如 Matt 稍後將詳述的那樣，我們最近完成了一系列金融交易，使我們的財務狀況更加穩固。

With this financing behind us, we can now focus on driving toward our new FDA clearances and the anticipated commercial launches of our next-generation Pantheris image-guided atherectomy devices later this year.

有了這筆融資，我們現在可以專注於推動我們新的 FDA 批准和我們的下一代 Pantheris 圖像引導粥樣斑塊切除術設備的預期商業發布，今年晚些時候。

I'm now going to provide a bit more color on our progress and also review some of the growth drivers we have ahead of us.

我現在要為我們的進展提供更多色彩，並回顧我們前面的一些增長動力。

After that, Matt will walk you through our recent financing transactions and our fourth quarter and full year financial results.

之後，馬特將向您介紹我們最近的融資交易以及我們的第四季度和全年財務業績。

Then we'll be happy to take your questions.

那麼我們很樂意回答您的問題。

On the product development and regulatory side, we've delivered on some significant milestones and made substantial progress toward others.

在產品開發和監管方面，我們已經實現了一些重要的里程碑，並在其他方面取得了實質性進展。

In December, we submitted our 510(k) application for clearance of the next-generation Pantheris catheter, and we continue to anticipate FDA clearance and initial introduction into the U.S. market in the first half of this year.

12 月，我們提交了下一代 Pantheris 導管的 510(k) 申請，我們繼續預計今年上半年將獲得 FDA 批准並首次進入美國市場。

Once we receive FDA clearance, our plan is to first introduce this next-generation device into a limited number of U.S. accounts, as we ramp-up production and gain purchasing approvals for rollout to our broader account base.

一旦我們獲得 FDA 許可，我們的計劃是首先將這種下一代設備引入有限數量的美國賬戶，因為我們會提高產量並獲得採購批准，以便推廣到我們更廣泛的賬戶群。

This also provides an excellent opportunity to gain additional clinical experience with this important new product, as we prepare for broader launch into our existing accounts.

這也提供了一個極好的機會，可以在我們準備更廣泛地投放到現有客戶時，通過這一重要的新產品獲得更多的臨床經驗。

As you may remember, we received CE Marking for our next-generation Pantheris in December, and in January, announced the treatment of the first patients globally, with this improved device at Dr. Arne Schwindt's labs in St.

您可能還記得，我們的下一代 Pantheris 在 12 月獲得了 CE 標誌，並於 1 月宣佈在聖路易斯的 Arne Schwindt 博士實驗室使用這種改進的設備治療全球首批患者。

Franziskus Hospital in Muenster, Germany.

德國明斯特的 Franziskus 醫院。

Since that time, we've expanded into an additional site in Germany, and our physician users continue to report outstanding clinical results in a variety of anatomies and lesion types.

從那時起，我們已經擴展到德國的另一個站點，我們的醫生用戶繼續報告各種解剖結構和病變類型的出色臨床結果。

Moving to the next product in our pipeline.

轉向我們管道中的下一個產品。

We expect to submit a 510(k) application for clearance of a lower-profile six-French Version of Pantheris for smaller vessels, including those below-the-knee by midyear 2018.

我們預計將在 2018 年年中之前提交一份 510(k) 申請，以批准用於小型船隻（包括膝蓋以下的船隻）的低調六法國版 Pantheris。

We expect to receive CE Marking for this new device around the same time we file our 510(k) in the U.S, which, similar to the next-generation Pantheris, would provide the opportunity for early clinical experience with this new lower-profile device in Europe soon after filing.

我們預計大約在我們在美國提交 510(k) 的同時獲得這款新設備的 CE 標誌，這與下一代 Pantheris 類似，將為這種新的低調設備提供早期臨床體驗的機會提交後不久在歐洲。

Based on our anticipated filing timeline, we continue to expect 510(k) clearance and initial U.S. launch later in the second half of this year.

根據我們預期的申請時間表，我們繼續預計今年下半年晚些時候 510(k) 批准和首次在美國上市。

We're excited about the prospects for this important new expansion of our Pantheris product line, since we believe our outstanding safety profile and the information provided by real-time imaging inside the artery will be critical differentiators for the treatment of smaller vessels, especially those below-the-knee.

我們對 Pantheris 產品線的這一重要新擴展的前景感到興奮，因為我們相信我們出色的安全性和動脈內實時成像提供的信息將成為治療較小血管的關鍵差異化因素，尤其是那些膝蓋以下。

Given the small size of the vessels being treated, this product design also eliminates the need for an inflation system to provide apposition and occlusion, which makes the product even easier to use and results in a more streamlined procedure.

鑑於所治療血管的尺寸較小，該產品設計還消除了充氣系統提供並置和閉塞的需要，這使得該產品更易於使用，並使程序更加簡化。

We believe this new device will expand our available market opportunity by as much as 50%, and therefore, will also result in an increased utilization by our customers.

我們相信這款新設備會將我們可用的市場機會擴大 50%，因此也會提高我們客戶的利用率。

In addition to these important new products for Pantheris, our R&D team has made excellent progress in the development of our next-generation CTO crossing device.

除了 Pantheris 的這些重要新產品外，我們的研發團隊在開發下一代 CTO 交叉設備方面也取得了出色的進展。

For those of you who are new to Avinger or the peripheral vascular space, CTOs are Chronic Total Occlusions, referred to completely blocked arteries.

對於那些剛接觸 Avinger 或周圍血管空間的人來說，CTO 是慢性完全閉塞，指的是完全阻塞的動脈。

CTOs are the most common reason that patients require bypass surgery and they're a leading cause of amputation.

CTO 是患者需要搭橋手術的最常見原因，也是截肢的主要原因。

By successfully crossing a CTO, a guidewire can be introduced and the underlying disease can be treated, the atherectomy, dilation of a balloon or some other method.

通過成功穿過 CTO，可以引入導絲並可以治療潛在的疾病、粥樣斑塊切除術、球囊擴張或一些其他方法。

Our Ocelot family of catheters are the only image-guided CTO crossing catheters on the market and have some of the strongest clinical data ever recorded for a CTO crossing device.

我們的 Ocelot 導管系列是市場上唯一的圖像引導 CTO 交叉導管，並且擁有一些 CTO 交叉設備有史以來最強大的臨床數據。

With 97% success in crossing CTOs and peripheral arteries and 98% freedom for major adverse events in the 100-patient CONNECT II study, which supported Ocelot's FDA clearance in 2012.

在 100 名患者參與的 CONNECT II 研究中，97% 的患者成功穿越 CTO 和外周動脈，98% 的主要不良事件均未發生，該研究支持 Ocelot 在 2012 年獲得 FDA 批准。

This more mature product line is highly reliable and continues to deliver strong clinical results every day and remains an important contributor to our Lumivascular franchise.

這個更成熟的產品線非常可靠，每天都在繼續提供強大的臨床結果，並且仍然是我們 Lumivascular 特許經營權的重要貢獻者。

However, as with Pantheris, we see an opportunity to improve and expand this platform with a next-generation device we're calling Ocellaris.

然而，與 Pantheris 一樣，我們看到了通過我們稱為 Ocellaris 的下一代設備改進和擴展該平台的機會。

Ocellaris will have rotation speeds of 1,000 revolutions per minute compared to 60 rpm for our current Ocelot device.

Ocellaris 的轉速為每分鐘 1,000 轉，而我們目前的 Ocelot 設備為每分鐘 60 轉。

We expect this to result in higher-definition, real-time imaging similar to the imaging experienced with Pantheris.

我們希望這會產生類似於 Pantheris 所經歷的成像的更高清晰度的實時成像。

We also believe that faster rotation speeds, along with a unique steerable proprietary tip design, will result in enhanced CTO crossing capability in a variety of lesion types.

我們還相信，更快的旋轉速度，以及獨特的可操縱專有尖端設計，將導致在各種病變類型中增強 CTO 交叉能力。

This new catheter is also expected to feature a low-profile design that allows for five-French sheath compatibility, which would be suitable for use in smaller vessels, including those below-the-knee.

這種新型導管還有望採用低調設計，可兼容五法式護套，適用於較小的血管，包括膝蓋以下的血管。

We anticipate completing development of this next-generation device in 2018 and submitting a 510(k) application for use in the peripheral arteries prior to the end of this year.

我們預計在 2018 年完成該下一代設備的開發，並在今年年底之前提交用於外周動脈的 510(k) 申請。

We're also excited that much of the R&D work for this next-generation, image-guided CTO crossing device will be directly leverageable to the coronary arteries, which we believe, represents an important potential future market for us, where precise control and the safety provided by real-time imaging are of paramount importance.

我們也很高興這一下一代圖像引導 CTO 穿越設備的大部分研發工作將直接用于冠狀動脈，我們相信這對我們來說代表著一個重要的潛在未來市場，精確控制和實時成像提供的安全性至關重要。

Now turning to our clinical activities, where we have a number of significant programs underway.

現在轉向我們的臨床活動，我們正在進行許多重要的項目。

Last October, we announced that we began enrollment of our INSIGHT IDE trial, our pivotal clinical study to evaluate the safety and effectiveness of Pantheris in treating instant restenosis or ISR.

去年 10 月，我們宣布開始招募我們的 INSIGHT IDE 試驗，這是我們的關鍵臨床研究，旨在評估 Pantheris 在治療即時再狹窄或 ISR 方面的安全性和有效性。

As you may recall, while Pantheris is not contraindicated for ISR, the results of this study are intended to support a 510(k) submission with the FDA to expand the Pantheris product label to specifically include the ISR indication, which would enable us to directly promote Pantheris for this purpose in the U.S. We are optimistic about Pantheris' potential role in this challenging area, which represents approximately 20% of PAD procedures in the U.S. Our trial is approved for up to 140 patients at up to 20 sites.

您可能還記得，雖然 Pantheris 不是 ISR 的禁忌症，但本研究的結果旨在支持向 FDA 提交 510(k) 以擴大 Pantheris 產品標籤以明確包括 ISR 適應症，這將使我們能夠直接為此目的在美國推廣 Pantheris。我們對 Pantheris 在這個具有挑戰性的領域中的潛在作用持樂觀態度，該領域約占美國 PAD 程序的 20%。我們的試驗已獲准在多達 20 個地點的多達 140 名患者中進行。

In the fourth quarter, we started out with our 2 principal investigator sites.

在第四季度，我們從我們的 2 個主要研究者站點開始。

We've opened 2 additional sites so far in the first quarter and expect to have 16 sites open for enrollment by the end of April.

到目前為止，我們在第一季度又開設了 2 個站點，預計到 4 月底將有 16 個站點開放註冊。

This includes the 2 sites in Europe, which have already begun to use the next-generation Pantheris in their clinical practice.

這包括歐洲的 2 個站點，它們已經開始在其臨床實踐中使用下一代 Pantheris。

We expect that most of the enrollment in this trial will take place once the next-generation Pantheris is commercially available in the U.S. and plan to complete enrollment of the INSIGHT trial this year.

我們預計，該試驗的大部分註冊將在下一代 Pantheris 在美國上市後進行，併計劃在今年完成 INSIGHT 試驗的註冊。

Earlier this quarter, our Lumivascular technology was also featured in presentations at the Leipzig Interventional Course, more commonly referred to as LINC.

本季度早些時候，我們的 Lumivascular 技術也在萊比錫介入課程（通常稱為 LINC）的演講中亮相。

A successful live case was performed with our next-generation Pantheris and broadcast live at the conference, and highly positive single-site clinical data collected using our Lumivascular platform was also presented.

我們的下一代 Pantheris 進行了一個成功的現場案例，並在會議上進行了現場直播，還展示了使用我們的 Lumivascular 平台收集的高度積極的單點臨床數據。

In addition to our product development and clinical activities, we also have important reimbursement initiatives underway.

除了我們的產品開發和臨床活動外，我們還在進行重要的報銷計劃。

First, we plan to file an application for a new CPT code for OCT diagnostic reimbursement in the U.S. by the end of the second quarter.

首先，我們計劃在第二季度末之前在美國提交新的 CPT 代碼申請，用於 OCT 診斷報銷。

Our goal is to gain incremental reimbursement for OCT diagnostic imaging for our devices in the peripheral arteries, similar to the reimbursement currently provided for the use of intravascular ultrasound or IVUS in this setting.

我們的目標是為我們的外周動脈設備獲得 OCT 診斷成像的增量報銷，類似於目前為在這種情況下使用血管內超聲或 IVUS 提供的報銷。

While the FDA has already cleared OCT diagnostic claims for our Pantheris and Ocelot devices, we anticipate that this CPT application would be supported by a small-scale clinical trial, which we are in the process of initiating here in the U.S. This study will compare OCT diagnostic imaging to IVUS in the peripheral arteries.

雖然 FDA 已經批准了我們的 Pantheris 和 Ocelot 設備的 OCT 診斷聲明，但我們預計該 CPT 應用將得到一項小規模臨床試驗的支持，我們正在美國這裡啟動這項研究。這項研究將比較 OCT外周動脈 IVUS 的診斷成像。

Remember that strong reimbursement already exists for atherectomy procedures in the peripheral arteries in the U.S., reimbursement that our Pantheris device already qualifies for.

請記住，在美國，外周動脈的粥樣斑塊切除術已經有很強的報銷，我們的 Pantheris 設備已經有資格獲得報銷。

If we're successful in obtaining this new CPT code for OCT diagnostic reimbursement, we expect it would be incremental to current reimbursement levels, and we anticipate the new code would apply to any of our Lumivascular devices: Pantheris, Ocelot or future OCT image-guided products.

如果我們成功獲得用於 OCT 診斷報銷的新 CPT 代碼，我們預計它將增加到當前的報銷水平，並且我們預計新代碼將適用於我們的任何 Lumivascular 設備：Pantheris、Ocelot 或未來的 OCT 圖像-導產品。

Along the same lines, you may have seen our recent announcement that the Institute for Medical Documentation and Information in Germany established a tracking code, known as an OPS code, for peripheral vascular OCT imaging.

同樣，您可能已經看到我們最近的公告，即德國醫學文獻和信息研究所建立了一個跟踪代碼，稱為 OPS 代碼，用於外周血管 OCT 成像。

This tracking code also will apply to both Avinger's Pantheris image-guided atherectomy devices and Ocelot family of catheters for CTO crossing, which utilize OCT imaging as part of our proprietary Lumivascular platform.

該跟踪代碼還將適用於 Avinger 的 Pantheris 圖像引導動脈粥樣硬化斑塊切除術設備和用於 CTO 交叉的 Ocelot 導管系列，它們利用 OCT 成像作為我們專有的 Lumivascular 平台的一部分。

So while no incremental reimbursement has been assigned at this point, the tracking code is in place to gather data that could provide support for higher reimbursement in Germany in the future.

因此，雖然此時沒有分配增量報銷，但跟踪代碼已到位以收集數據，這些數據可以為德國未來更高的報銷提供支持。

While we've a lot of attention on the pipeline in future opportunities, our commercial organization, which now numbers 18 people in the field, has been maintaining its focus on driving utilization in existing accounts and also generating valuable clinical experience in Europe.

雖然我們非常關注未來機會的管道，但我們的商業組織（目前該領域有 18 名員工）一直專注於推動現有客戶的利用率，並在歐洲產生寶貴的臨床經驗。

We expect that the commercial introduction of the next-generation Pantheris and the lower-profile six-French Pantheris for smaller vessels will expand our market and begin to drive revenue growth, as we move through the year.

我們預計，隨著我們今年的推進，下一代 Pantheris 和用於小型船舶的低調 6 艘法國 Pantheris 的商業推出將擴大我們的市場並開始推動收入增長。

In addition, as we demonstrate increasing productivity at the accountant territory levels, we expect to make strategic additions to our sales force, when and where appropriate, on a limited basis throughout the year.

此外，由於我們在會計領域展示了生產力的提高，我們希望在適當的時候和適當的地方，在全年的有限基礎上對我們的銷售隊伍進行戰略性補充。

We ended the fourth quarter with 152 Lumivascular accounts, a slight decrease from the 157 accounts at the end of the third quarter, but in line with our focus on allocating our resources to more productive territories and accounts and supporting utilization in active accounts.

第四季度結束時，我們有 152 個 Lumivascular 賬戶，比第三季度末的 157 個賬戶略有減少，但這符合我們將資源分配給更俱生產力的地區和賬戶以及支持活躍賬戶利用的重點。

As we anticipate new product introductions later this year, we'll renew our efforts for strategic new account acquisitions and covered sales territories, with a focus on efficiency and productivity in our commercial organization.

由於我們預計今年晚些時候會推出新產品，因此我們將重新努力進行戰略性新客戶收購和覆蓋的銷售區域，重點關注我們商業組織的效率和生產力。

In summary, we feel that our business is headed in the right direction, with substantial product -- progress made with our product development, clinical, regulatory and operations teams over the last several months.

總而言之，我們認為我們的業務正朝著正確的方向發展，我們的產品開發、臨床、監管和運營團隊在過去幾個月中取得了實質性進展。

We're excited about the future, more aligned than ever, and committed to achieving the important milestones and exciting growth opportunities we have ahead of us in 2018 and beyond.

我們對未來感到興奮，比以往任何時候都更加一致，並致力於實現我們在 2018 年及以後的重要里程碑和令人興奮的增長機會。

At this point, I'd like to ask Matt to review the details of our recent progress with our financial structure and review our fourth quarter financial results, and then we'll open the call for your questions.

在這一點上，我想請馬特審查我們最近在財務結構方面取得進展的細節，並審查我們第四季度的財務業績，然後我們將開始徵求您的問題。

Okay.

好的。

Thank you, Jeff.

謝謝你，傑夫。

Since the beginning of 2018, we've made big strides on the financial side of the business, which now gives us the financial resources we need to focus on our upcoming approvals and planned launches.

自 2018 年初以來，我們在業務的財務方面取得了長足進步，這為我們提供了專注於即將到來的批准和計劃啟動所需的財務資源。

Most importantly, in February, we successfully completed a new equity raise with gross proceeds of $18 million.

最重要的是，2 月，我們成功完成了新的股權融資，總收益為 1800 萬美元。

In conjunction with the equity transaction, our lender, CRG, converted $38 million of their debt into preferred equity.

結合股權交易，我們的貸方 CRG 將其 3800 萬美元的債務轉換為優先股。

This leaves us with just $6.5 million of debt, which is an 85% reduction from previous levels.

這使我們只剩下 650 萬美元的債務，比以前的水平減少了 85%。

The equity offering also included 2 series of warrants, both with an exercise price of $2 per share.

股權發行還包括 2 個系列的認股權證，行使價均為每股 2 美元。

The Series 1 warrants expire in February of 2025 and the Series 2 warrants contain a feature providing that if they are in the money during the 60 days after we achieve FDA clearance of our small vessel Pantheris, these warrants would have to be exercised by that date.

系列 1 認股權證於 2025 年 2 月到期，系列 2 認股權證包含一項功能，即如果它們在我們的小型船隻 Pantheris 獲得 FDA 批准後的 60 天內處於盈利狀態，則必須在該日期之前行使這些認股權證.

If they're not yet in the money during the 60 days following the FDA clearance, their expiration is extended to the February 2025 date, the same as the Series 1 warrants.

如果他們在 FDA 批准後的 60 天內還沒有兌現，他們的到期日將延長至 2025 年 2 月，與系列 1 認股權證相同。

As Jeff mentioned, we expect to receive this FDA clearance prior to the end of this year, so the exercise of these warrants at that point would provide up to $18 million in additional cash to support our ongoing operations.

正如 Jeff 所提到的，我們希望在今年年底之前獲得 FDA 的批准，因此屆時行使這些認股權證將提供高達 1800 萬美元的額外現金來支持我們的持續運營。

The Series 1 warrants could also provide an additional infusion of cash up to a maximum of $18 million if they are exercised at any point prior to expiration.

如果在到期前的任何時間點行使 1 系列認股權證，還可以提供最多 1800 萬美元的額外現金注入。

Prior to these financing transactions, we announced the 1-for-40 reverse stock split that became effective on January 30.

在這些融資交易之前，我們宣布了 1 月 30 日生效的 40 股反向股票分割。

We did this in order to increase the share price and to regain compliance with NASDAQ Capital Markets listing requirements.

我們這樣做是為了提高股價並重新遵守納斯達克資本市場的上市要求。

And on March 2, we announced that we had achieved compliance with all these requirements, including the minimum bid price rule, the market value of publicly held shares rule and the market value of listed securities rule.

並且在 3 月 2 日，我們宣布我們已經達到了所有這些要求的合規性，包括最低出價規則、公開持有股票的市值規則和上市證券的市值規則。

Now turning to our financials.

現在轉向我們的財務狀況。

Total revenue was $1.9 million for the fourth quarter ended December 31, 2017, a 59% decrease from the fourth quarter of 2016.

截至 2017 年 12 月 31 日的第四季度總收入為 190 萬美元，較 2016 年第四季度下降 59%。

Revenue from disposable devices was $1.5 million for the quarter, a 58% decrease from the fourth quarter of 2016.

本季度一次性設備的收入為 150 萬美元，比 2016 年第四季度下降 58%。

And revenue related to Lightbox imaging consoles was $0.4 million, a 61% decrease compared to the fourth quarter of 2016.

與 Lightbox 影像控制台相關的收入為 40 萬美元，與 2016 年第四季度相比下降了 61%。

At the end of the fourth quarter, our Lumivascular install base was 152 accounts, which was a slight decrease from the 157 at the end of Q3.

第四季度末，我們的 Lumivascular 安裝基數為 152 個賬戶，比第三季度末的 157 個略有下降。

Gross margin for the fourth quarter of 2017 was 9%, down from 21% in the comparable quarter of 2016.

2017 年第四季度的毛利率為 9%，低於 2016 年同期的 21%。

Gross margin for the quarter was impacted primarily by lower production volumes versus the prior year, as we reduced existing inventories in anticipation of the clearance and launch of the next-generation Pantheris.

本季度的毛利率主要受到產量低於上一年的影響，因為我們減少了現有庫存以預期下一代 Pantheris 的清關和推出。

Operating expenses for the fourth quarter of 2017 were $8.8 million compared to $12.9 million in the fourth quarter of 2016.

2017 年第四季度的運營費用為 880 萬美元，而 2016 年第四季度為 1290 萬美元。

This decrease was primarily attributable to reduced headcount expenses compared to the fourth quarter of 2016.

這一減少主要是由於與 2016 年第四季度相比員工費用減少。

Operating expenses for the fourth quarter of 2017 included a $1.8 million expense related to the anticipated settlement of outstanding shareholder class action litigation as well as the $350,000 restructuring expense, primarily related to the sublease of a portion of the company's facilities during the quarter.

2017 年第四季度的運營費用包括 180 萬美元與未決股東集體訴訟的預期和解相關的費用，以及 350,000 美元的重組費用，主要與本季度公司部分設施的轉租有關。

Loss from operations for the fourth quarter of 2017 was $8.6 million compared to $12.0 million for the fourth quarter of 2016, and net loss for the fourth quarter of 2017 was $10.2 million compared to $13.5 million for the fourth quarter of 2016.

2017 年第四季度運營虧損為 860 萬美元，而 2016 年第四季度為 1200 萬美元，2017 年第四季度淨虧損為 1020 萬美元，而 2016 年第四季度為 1350 萬美元。

Loss per share for the fourth quarter of 2017 was a loss of -- or $12.58 compared to a loss of $23.35 for the fourth quarter of 2016.

2017 年第四季度每股虧損為 12.58 美元，而 2016 年第四季度為虧損 23.35 美元。

Adjusted EBITDA, a non-GAAP measure, was a loss of $5.4 million for the fourth quarter of 2017 compared to a loss of $9.5 million for the fourth quarter of 2016.

調整後的 EBITDA 是一項非 GAAP 指標，2017 年第四季度虧損 540 萬美元，而 2016 年第四季度虧損 950 萬美元。

Now looking briefly at our full year 2017 results.

現在簡要回顧一下我們 2017 年的全年業績。

Total revenue was $9.9 million for 2017, a 48% decrease from 2016.

2017 年總收入為 990 萬美元，比 2016 年下降 48%。

Lightbox imaging console revenues were $1.9 million, a 61% decrease compared to 2016, and revenues from disposable devices were $8.1 million, a 44% decrease compared to 2016.

Lightbox 影像控制台收入為 190 萬美元，與 2016 年相比下降 61%，一次性設備收入為 810 萬美元，與 2016 年相比下降 44%。

Gross margin for 2017 was negative 31%, down from 25% in 2016.

2017 年的毛利率為負 31%，低於 2016 年的 25%。

The decrease was primarily related to the decreased production volumes as well as higher costs related to product warranties and excess and obsolete inventory.

減少主要與產量減少以及與產品保修和過剩和過時庫存相關的成本增加有關。

Operating expenses for 2017 were $39.5 million compared to $55.5 million in 2016.

2017 年的運營費用為 3950 萬美元，而 2016 年為 5550 萬美元。

The decrease was primarily attributable to lower headcount expense, corresponding to a reduction in overall headcount from 197 at year-end 2016 to 65 at year-end 2017.

減少的主要原因是員工費用減少，總員工人數從 2016 年底的 197 人減少到 2017 年底的 65 人。

Loss from operations for 2017 was $42.6 million compared to a loss of $50.7 million for 2016.

2017 年的運營虧損為 4260 萬美元，而 2016 年為虧損 5070 萬美元。

And loss per share for 2017 was $74.74 compared to $135.57 in 2016.

2017 年每股虧損為 74.74 美元，而 2016 年為 135.57 美元。

Adjusted EBITDA for the year was a loss of $33.1 million for 2017 compared to $41.8 million as a loss for 2016.

2017 年全年調整後 EBITDA 虧損 3310 萬美元，而 2016 年虧損 4180 萬美元。

Cash and cash equivalents totaled $5.4 million as of December 31, 2017, compared to $10.2 million as of September 30, 2017.

截至 2017 年 12 月 31 日，現金和現金等價物總計 540 萬美元，而截至 2017 年 9 月 30 日為 1,020 萬美元。

Pro forma for our recent equity financing and debt restructuring, the company would have had cash and cash equivalents of $21.4 million and debt of $6.5 million as of December 31, 2017.

根據我們最近的股權融資和債務重組的備考，截至 2017 年 12 月 31 日，公司的現金和現金等價物為 2140 萬美元，債務為 650 萬美元。

Currently, there are approximately 3.6 million shares of common stock outstanding and there are also currently, approximately 42,000 shares of Series A preferred stock at approximately 13,000 shares of Series B preferred stock outstanding.

目前，約有 360 萬股已發行普通股，目前還有約 42,000 股 A 系列優先股和約 13,000 股已發行 B 系列優先股。

Assuming conversion of all preferred stock, we would have approximately 31 million shares of common stock outstanding.

假設轉換所有優先股，我們將有大約 3100 萬股已發行普通股。

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

在這一點上，我想把電話轉回給傑夫。

Thanks, Matt.

謝謝，馬特。

We're pleased with how we're positioned entering 2018 and enthusiastic about our future.

我們對進入 2018 年的定位感到滿意，並對我們的未來充滿熱情。

The financing transactions we've recently completed have put us in a much stronger financial position as we execute against our plans.

我們最近完成的融資交易使我們在執行計劃時處於更強大的財務狀況。

And we have a number of important milestones ahead of us in 2018 that we believe will fundamentally change our value proposition and position us for growth in the back half of the year and into 2019 and beyond.

我們在 2018 年有許多重要的里程碑，我們相信它們將從根本上改變我們的價值主張，並使我們在今年下半年和 2019 年及以後實現增長。

Our 2018 milestones include: expected FDA clearance and launch of our next-generation Pantheris in the first half of this year; anticipated filing of our 510(k) application for our lower-profile six-French Pantheris for smaller vessels midyear, with expected FDA clearance and initial launch prior to the end of the year; anticipated filing by the end of the second quarter of a CPT application for incremental OCT diagnostic reimbursement in the peripheral arteries; completion of enrollment in our INSIGHT IDE study for the treatment of in-stent restenosis with Pantheris this year, and the anticipated filing of a 510(k) application for Ocellaris, our next-generation CTO crossing catheter in the second half of the year.

我們 2018 年的里程碑包括：預計在今年上半年獲得 FDA 批准並推出我們的下一代 Pantheris；預計將在年中提交我們的 510(k) 申請，用於較小型船隻的低調 6 艘法國黑豹，預計 FDA 批准並在年底前首次推出；預計在第二季度末提交外周動脈增量 OCT 診斷報銷的 CPT 申請；今年我們完成了用 Pantheris 治療支架內再狹窄的 INSIGHT IDE 研究的註冊，並預計在今年下半年提交我們下一代 CTO 交叉導管 Ocellaris 的 510(k) 申請。

In the U.S., we'll continue our sales team's focus on driving utilization in existing accounts and preparing for launch of our next-generation products into existing and new accounts, following FDA clearance, and we'll maintain our dedicated efforts on driving improvements in efficiency and the productivity throughout the organization, with a strong focus on minimizing cash usage throughout the year.

在美國，我們的銷售團隊將繼續專注於推動現有客戶的利用率，並準備在 FDA 批准後向現有客戶和新客戶推出我們的下一代產品，我們將繼續致力於推動改進整個組織的效率和生產力，重點是盡量減少全年的現金使用。

And with that, we'd be happy to take your questions.

因此，我們很樂意回答您的問題。

(Operator Instructions) And our first question will come from the line of Jeffrey Cohen with Ladenburg.

（操作員說明）我們的第一個問題將來自 Jeffrey Cohen 和 Ladenburg 的台詞。

This is actually Destiny on for Jeffrey.

這實際上是杰弗裡的命運。

Specifically, to the sales force, I know you mentioned that you may add a couple where appropriate, is there a certain number or a certain territory that you're aiming towards or are you feeling it out more as you introduce the new products?

具體來說，對於銷售人員，我知道你提到過你可能會在適當的時候增加一對，你的目標是一定的數量或一定的領域，還是在介紹新產品時你會感覺到更多？

Destiny, as you may remember, we had a much larger sales force as we exited 2016, with almost 60 sales folks, and we went through a strategic process throughout the year of really refining that group to focus on our best territories and our best -- with our best reps, as we prepare for the launch of the new products.

Destiny，你可能還記得，我們在 2016 年結束時擁有一支更大的銷售隊伍，有近 60 名銷售人員，我們在這一年中經歷了一個戰略過程，真正完善該團隊以專注於我們最好的領域和我們最好的 - - 與我們最好的代表一起，為新產品的發布做準備。

We don't anticipate building our sales force up in advance of the launch of the new products.

我們預計不會在新產品發布之前建立我們的銷售隊伍。

But as we launch those products, introduce them into our existing accounts and then start to gain traction and drive growth, we'll expand our sales force kind of commensurate with growth and the desire to expand into -- either deeper into existing territories or into new strategic territories.

但隨著我們推出這些產品，將它們引入我們現有的客戶，然後開始獲得牽引力並推動增長，我們將擴大我們的銷售隊伍，以適應增長和擴張的願望——要么深入現有領域，要么進入新的戰略領土。

So I would think of this as a modest expansion this year.

所以我認為這是今年的適度擴張。

But -- and I would anticipate that the increases to happen more in the latter part of the second quarter and into the second half of the year.

但是 - 我預計第二季度後期和今年下半年會出現更多增長。

But we're not putting out a specific target.

但我們沒有提出具體目標。

We're going to be very kind of business-driven and progress-driven as we go throughout the year.

在全年中，我們將非常以業務為導向，以進步為導向。

Got it.

知道了。

I appreciate that.

我很感激。

I'm also just curious, you mentioned that you (inaudible) also require a (inaudible) trials compared the two.

我也很好奇，您提到您（聽不清）還需要對兩者進行（聽不清）試驗。

Do you kind of have a timeline or are you waiting until -- you could get a little bit more feedback.

您是否有時間表，或者您是否正在等待——您可以獲得更多反饋。

So Destiny, you were breaking up, but I think what you asked about was the timeline for the clinical trial that would be conducted in advance of filing our CPT application.

所以命運，你分手了，但我想你問的是在提交我們的 CPT 申請之前進行的臨床試驗的時間表。

Was that what the question was around?

這就是問題所在嗎？

Yes, that's correct.

對，那是正確的。

I'm sorry if I'm breaking up.

如果我要分手，我很抱歉。

No, that's fine.

不，沒關係。

So that study, which is called the Scan study, we have our protocols approved and our initial site selected.

因此，這項研究被稱為掃描研究，我們已經批准了我們的方案並選擇了我們的初始地點。

It's a relatively small-scale study, it'll be in 3 sites: one interventional radiologist, one interventional cardiologist and one vascular surgeon.

這是一項規模相對較小的研究，將在 3 個地點進行：一名介入放射科醫生、一名介入心髒病專家和一名血管外科醫生。

The study is in those 3 sites, for just up to 20 patients.

這項研究是在這 3 個地點進行的，最多只針對 20 名患者。

There'll about 120 images captured for OCT and IVUS in the study and evaluated as part of this comparative study but not a lot of patients, just up to 20 patients.

在這項研究中，將為 OCT 和 IVUS 捕獲大約 120 張圖像，並作為該比較研究的一部分進行評估，但患者數量不多，最多 20 名患者。

So we anticipate that we will complete that study in the second quarter in time for filing our CPT applications at the end -- application at the end of the quarter.

因此，我們預計我們將在第二季度及時完成這項研究，以便在月底提交我們的 CPT 申請——在季度末提交申請。

And we do intend to announce when we formally begin enrollment in that study.

我們確實打算宣布我們正式開始參加該研究的時間。

(Operator Instructions) And I'm showing no further questions over the phone line.

（操作員說明）而且我不會通過電話線顯示更多問題。

So now it's my pleasure to hand the conference back over to Mr. Jeff Soinski for some closing comments and remarks.

因此，現在我很高興將會議交還給 Jeff Soinski 先生，讓他發表一些閉幕評論和評論。

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。

Thank you.

謝謝。

Ladies and gentlemen, thank you for your participation on today's conference.

女士們，先生們，感謝你們參加今天的會議。

This does conclude our program and we may all disconnect.

這確實結束了我們的計劃，我們可能都會斷開連接。

Everybody, have a wonderful day.

大家，祝你有美好的一天。