Avinger Inc (AVGR) 2016 Q4 法說會逐字稿

Good day, ladies and gentlemen. Welcome to the Avinger fourth quarter 2016 earnings conference call. At this time, participants are in a listen-only mode. Later we will conduct a question and answer session, and instructions will follow at that time.

女士們先生們，美好的一天。歡迎來到 Avinger 2016 年第四季度收益電話會議。此時，參與者處於只聽模式。稍後我們將進行問答環節，屆時將進行說明。

(Operator Instructions)

（操作員說明）

As a reminder, this conference is being recorded. I would like to introduce your host for today's conference, Caroline Corner. Ma'am, you may begin.

提醒一下，這次會議正在錄製中。我想介紹一下今天會議的主持人 Caroline Corner。女士，您可以開始了。

Thank you, and thank you all for participating in today's call. Joining us today are Avinger's CEO, Jeff Soinski; Founder and Executive Chairman, Dr. John Simpson; and Chief Financial Officer, Matt Ferguson.

謝謝大家，也感謝大家參加今天的電話會議。今天加入我們的是 Avinger 的首席執行官 Jeff Soinski；創始人兼執行主席約翰·辛普森博士；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, 2016.

今天早些時候，Avinger 發布了截至 2016 年 12 月 31 日的全年和第四季度的財務業績。

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. Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements. All forward-looking statements including, without limitation, our future financial expectations are based upon our current estimates and various assumptions. 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. Accordingly, you should not place undue reliance on these statements.

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。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。所有前瞻性陳述，包括但不限於我們未來的財務預期，均基於我們當前的估計和各種假設。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。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. 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.

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。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. Good afternoon and thank you all for joining us.

謝謝，卡羅琳。下午好，謝謝大家加入我們。

Today, I would like to review a few key items from 2016 and also provide some updates as we look to leverage our installed base and launch new products over the next 12 months.

今天，我想回顧 2016 年的幾個關鍵項目，並提供一些更新，因為我們希望在未來 12 個月內利用我們的安裝基礎並推出新產品。

In the fourth quarter, total revenues grew 64% from the fourth quarter of 2015.

第四季度，總收入較 2015 年第四季度增長 64%。

We increased our installed base by 13 accounts and are now selling into 156 Lumivascular accounts, which surpassed our goal of 150 accounts by the end of 2016.

我們的安裝基礎增加了 13 個賬戶，現在正在向 156 個 Lumivascular 賬戶銷售，這超過了我們到 2016 年底達到 150 個賬戶的目標。

Before we discuss our commercialization plans, I'd like to provide an update on our Pantheris product development efforts as we progress the next generation Pantheris and our below-the-knee atherectomy device towards market launch. Our R&D and manufacturing teams have been working diligently to rollout a series of incremental improvements to our current version of Pantheris to improve the consistency and reliability of our currently marketed products while we are completing our verification and validation activities to ready the next generation of Pantheris for 510(k) submission midyear.

在我們討論我們的商業化計劃之前，我想介紹一下我們的 Pantheris 產品開發工作的最新情況，因為我們正在推進下一代 Pantheris 和我們的膝下斑塊切除術設備的上市。我們的研發和製造團隊一直在努力工作，對我們當前版本的 Pantheris 進行一系列漸進式改進，以提高我們當前銷售產品的一致性和可靠性，同時我們正在完成驗證和驗證活動，為下一代 Pantheris 做好準備510(k) 年中提交。

Recall that the new Pantheris device is a true upgrade, which brings a host of additional improvements and important new features and benefits to the Pantheris franchise, including more a robust shaft for better pushability and improved handle designs, a redesigned single balloon system for apposition and occlusion as well as an improved nosecone and longer nosecone option. This device will also include the addition of longitudinal markers on the shaft to further reduce the need for fluoroscopy and thereby decrease radiation exposure for physicians and patients.

回想一下，新的 Pantheris 設備是一次真正的升級，它為 Pantheris 特許經營帶來了許多額外的改進和重要的新功能和好處，包括更堅固的軸以提供更好的推動性和改進的手柄設計，重新設計的單氣球系統用於並置和閉塞以及改進的鼻錐和更長的鼻錐選項。該設備還將包括在軸上添加縱向標記，以進一步減少對熒光檢查的需要，從而減少醫生和患者的輻射暴露。

We believe that the multiple improvements in this next generation device will allow us to broaden the applicable procedure market especially in tough to treat lesions and that it will have a direct and an positive impact on increasing utilization rates in existing and new accounts. As mentioned on our last call, all these changes and improvements have been directly informed by the physician input we have received in the field during our first year of launch.

我們相信，這一下一代設備的多項改進將使我們能夠擴大適用的程序市場，尤其是在難以治療的病變中，並將對提高現有客戶和新客戶的利用率產生直接和積極的影響。正如我們在上次電話會議中提到的那樣，所有這些變化和改進都是在我們推出的第一年期間在該領域收到的醫生意見直接告知的。

We are proud of the rapport we've developed with our physician customers, and continue to be impressed with the outstanding clinical outcomes they have achieved. However, we acknowledge that the reliability of Pantheris during its first year in the market has not been where we need it to be.

我們為與醫生客戶建立的融洽關係感到自豪，並繼續對他們取得的出色臨床成果印象深刻。然而，我們承認 Pantheris 在上市第一年的可靠性並沒有達到我們需要的水平。

We will continue to support our key opinion leaders as they redefine the treatment of PAD with our Lumivascular devices, and with the next generation Pantheris bring them a completely updated catheter to expand their efforts.

我們將繼續支持我們的主要意見領袖，因為他們使用我們的 Lumivascular 設備重新定義了 PAD 的治療，並且下一代 Pantheris 為他們帶來了一個完全更新的導管以擴大他們的努力。

Turning to our below-the-knee device, our development efforts for our 6Fr version of Pantheris continue to remain on track. And we expect to file a 510(k) application for this device in the third quarter of 2017. As we have described before, this device is a lower profile and longer length than our existing Pantheris products and should enable much better penetration of the sizable below-the-knee market, where our outstanding safety profile takes on even greater importance.

談到我們的膝蓋以下設備，我們對 6Fr 版 Pantheris 的開發工作繼續保持在正軌上。我們預計將在 2017 年第三季度為該設備提交 510(k) 申請。正如我們之前所描述的，該設備比我們現有的 Pantheris 產品外形更小，長度更長，應該能夠更好地滲透到相當大的膝蓋以下的市場，我們出色的安全性在這些市場變得更加重要。

We are also excited about the progress we are making with this device since much of the R&D work for this lower profile device will be directly leveragable to coronaries, which is an exciting future market for us.

我們也對我們在該設備上取得的進展感到興奮，因為該低端設備的大部分研發工作將直接用于冠狀動脈，這對我們來說是一個令人興奮的未來市場。

You may recall from our last quarterly update, back in November, that we have received 510(k) clearance from the FDA in October, recognizing Pantheris as a technology that can be used for diagnostic purposes as well as its primary use as a therapeutic device.

您可能還記得我們去年 11 月份的季度更新，我們在 10 月份收到了 FDA 的 510(k) 許可，承認 Pantheris 是一種可用於診斷目的的技術，並且主要用作治療設備.

Concurrent with the 510(k) clearance of our upgraded L250 imaging counsel in December, we were able to add vessel measurement capabilities for Pantheris.

在 12 月升級後的 L250 成像顧問獲得 510(k) 許可的同時，我們能夠為 Pantheris 添加血管測量功能。

We believe these two new 510(k) clearances are critical since they provide important new capabilities for physicians and underscore the value of the clinical information provided by real time imaging. We also believe that the addition of these new diagnostic capabilities provides the functionality we need to support the pursuit of incremental diagnostic reimbursement for our Lumivascular devices, down the road.

我們認為這兩項新的 510(k) 許可至關重要，因為它們為醫生提供了重要的新功能，並強調了實時成像提供的臨床信息的價值。我們還相信，這些新診斷功能的添加提供了我們需要的功能，以支持我們在未來為我們的 Lumivascular 設備追求增量診斷報銷。

I'd now like to update you on our commercialization efforts. In the fourth quarter, the size of our sales force increased modestly; and at quarter-end, we had 60 sales professionals. While we're pleased with the efforts of our sales force in building our user base and increasing our fourth quarter disposable volume, a 118% year-over-year due to the launch of Pantheris, we continue to increase our focus on expanding device utilization in current and new accounts.

我現在想向您介紹我們的商業化工作的最新情況。第四季度，我們的銷售隊伍規模略有增加；在季度末，我們有 60 名銷售人員。雖然我們對我們的銷售團隊在建立用戶群和增加第四季度一次性使用量（由於 Pantheris 的推出而同比增長 118%）方面所做的努力感到滿意，但我們繼續更加關注擴大設備利用率在當前和新帳戶中。

As we look forward towards the expected launch of our next gen Pantheris and BTK devices in the latter part of 2017, we do not anticipate expanding our sales force in the near-term.

由於我們期待在 2017 年下半年推出我們的下一代 Pantheris 和 BTK 設備，我們預計短期內不會擴大我們的銷售隊伍。

We're also making changes in sales management, as we continue to refine our focus and get ready for the launch of our important new product initiatives. Earlier in the year, we promoted two of our most-experienced sales directors to area VPs with responsibility for sales for the eastern and western parts of the U.S.

隨著我們繼續完善我們的重點並為推出我們重要的新產品計劃做好準備，我們還對銷售管理進行了更改。今年早些時候，我們將兩名最有經驗的銷售總監提升為區域副總裁，負責美國東部和西部地區的銷售。

In addition, JD Simpson, who was promoted to SVP of Sales and Marketing in July of last year will be leaving the company effective March 10th to pursue other opportunities. As many of know J D has been with the company since its early days in a variety of roles and we wish him the best in his future endeavors.

此外，去年 7 月晉升為銷售和營銷高級副總裁的 JD Simpson 將於 3 月 10 日離職，以尋求其他機會。正如許多人所知，J D 自公司成立之初就一直在公司擔任各種職務，我們祝愿他在未來的工作中一切順利。

We recognize that we've had challenges in maintaining consistency in the sales leadership position. However, our two area sales VPs have been top performers with the company for six and over three years respectively and our VP of Marketing has been in his current position for more than four years. Going forward, all three of these commercial VPs will report directly to me, as they have previously.

我們認識到，我們在保持銷售領導地位的一致性方面遇到了挑戰。然而，我們的兩位區域銷售副總裁分別在六年和三年多的時間裡一直是公司的佼佼者，而我們的營銷副總裁擔任現職已經四年多了。展望未來，所有這三位商業副總裁都將像以前一樣直接向我匯報。

We do not plan to replace the Senior Vice President position, which will bring more efficiency to the organization and allow me to be closer to our commercial activities.

我們不打算更換高級副總裁職位，這將為組織帶來更高的效率，並讓我更接近我們的商業活動。

We continue to believe that Pantheris will be a game-changer in the treatment of PAD, and our product development regulatory and physician training teams are all working hard to ready our new products for launch.

我們仍然相信 Pantheris 將改變 PAD 治療的遊戲規則，我們的產品開發監管和醫師培訓團隊都在努力準備我們的新產品上市。

Our management team is currently working to refine our new product launch plans and forecasts for the balance of 2017, based on the most current information available to us. As a result, we will not provide financial guidance on this call. However, we do plan to provide financial guidance for the year once this process is complete, which we expect to occur by our next quarterly call.

我們的管理團隊目前正在根據我們可獲得的最新信息，完善我們的新產品發布計劃和 2017 年剩餘時間的預測。因此，我們不會就此電話會議提供財務指導。但是，我們確實計劃在這個過程完成後提供當年的財務指導，我們預計會在下一個季度電話會議上實現。

I'd now like to ask Dr. Simpson to elaborate on our recent clinical and development progress and to speak about some of our near-term R&D priorities. Following Dr. Simpson's remarks, Matt will review our Q4 financial results, and then we'll open the call for your questions. John?

我現在想請辛普森博士詳細說明我們最近的臨床和開發進展，並談談我們近期的一些研發重點。在辛普森博士發表講話後，馬特將回顧我們第四季度的財務業績，然後我們將開始徵求您的問題。約翰？

Thanks Jeff. So, we've had continued good clinical news this quarter, and I'd like to take this opportunity to update everyone just on a few of our recent successes.

謝謝杰夫。因此，本季度我們一直有良好的臨床新聞，我想藉此機會向大家介紹我們最近取得的一些成功。

So, as many of you will recall, we previously reported the original data from the VISION study, which included six-month follow-up on patients treated with Pantheris. This was used to support our initial 510(k) clearance with the FDA in 2015.

因此，正如你們中的許多人會記得的那樣，我們之前報告了 VISION 研究的原始數據，其中包括對接受 Pantheris 治療的患者進行為期六個月的隨訪。這用於支持我們在 2015 年獲得 FDA 的初步 510(k) 批准。

In 2016, we made the decision to reopen the follow-up to collect data through 12 and 24 months on as many of the patients that were originally VISION trial as many as possible. The interim results of these data were very promising and were presented recently as an interim cohort by Dr. Ian Cawich from the Arkansas Heart Hospital. He presented his data at the Leipzig Interventional Course in Germany, more commonly referred to as LINC.

2016 年，我們決定重新開始隨訪，以盡可能多地收集最初參加 VISION 試驗的患者在 12 個月和 24 個月內的數據。這些數據的中期結果非常有希望，最近由阿肯色州心髒病醫院的 Ian Cawich 博士作為中期隊列進行了介紹。他在德國萊比錫介入課程（通常稱為 LINC）中展示了他的數據。

The data that Dr. Cawich presented from target lesion revascularization, TLR at12 months and 24 months which were 86% and 82% respectively, based on Kaplan-Meier curve estimates. There were no amputations. Furthermore, the statistically significant improvements in ankle brachial indices, ABI, and the Rutherford classification that we saw at 30 days and 6 months were maintained through the 24 months timeframe.

Cawich 博士提供的數據來自靶病變血運重建，12 個月和 24 個月的 TLR 分別為 86% 和 82%，基於 Kaplan-Meier 曲線估計。沒有截肢。此外，我們在 30 天和 6 個月時看到的踝臂指數、ABI 和盧瑟福分類的統計學顯著改善在 24 個月的時間範圍內得到保持。

Finally, I'll mention that a majority of the lesions were originally treated using standalone OCT guided atherectomy with the Pantheris catheter, while only 9.6% of the overall VISION population, they were actually receiving adjunctive drug coated balloon therapy and only 5% receiving adjunctive stent therapy.

最後，我要提到的是，大多數病變最初是使用獨立的 OCT 引導動脈粥樣硬化斑塊切除術和 Pantheris 導管進行治療的，而只有 9.6% 的 VISION 總人口，他們實際上接受了輔助藥物塗層球囊治療，只有 5% 接受輔助治療支架療法。

While these results are definitely encouraging, it's also important to emphasize that the study data we generated following the treatment with the first clinical version of the Pantheris in the hands of new users with no previous Pantheris experience. We're excited about the results with the next generation Pantheris and especially in the hands of some of the long-term Pantheris users. We continue to gather data on the remaining VISION patients and expect to have all the data in-house in the next two to three months.

雖然這些結果絕對令人鼓舞，但同樣重要的是要強調，我們在使用第一個臨床版本的 Pantheris 治療後生成的研究數據掌握在沒有 Pantheris 經驗的新用戶手中。我們對下一代 Pantheris 的結果感到興奮，尤其是在一些 Pantheris 的長期用戶手中。我們繼續收集剩餘 VISION 患者的數據，並期望在接下來的兩到三個月內獲得所有內部數據。

Also at LINC, Dr. Marianne Brodmann of the Medical University of Graz in Austria presented an independent study -- prospective case series actually on 30 patients, 35 lesions with long-term follow-up including patency as measured by duplex ultrasound; and freedom from target lesion revascularization at 6 and 12 months were two of the important endpoints in this study. The study represented the first cohort of patient outcomes using duplex ultrasound to document patency and that patency was documented to be 89% at 6 months, 86% at 12 months. OCT guided atherectomy achieved 84% standalone luminal gain, and two thirds of these lesions in her study were CTOs. Standalone true lumen crossing was achieved in 95% -- or 95% of the time using our Avinger CTO crossing device, we call the Ocelot. Dr. Broadmann's presentation also demonstrated the consistence of our data across studies.

同樣在 LINC 上，奧地利格拉茨醫科大學的 Marianne Brodmann 博士提出了一項獨立研究——前瞻性病例係列，實際上涉及 30 名患者，對 35 個病變進行了長期隨訪，包括通過多普勒超聲測量的通暢性； 6 個月和 12 個月時未進行靶病變血運重建是本研究的兩個重要終點。該研究代表了第一批使用多普勒超聲記錄通暢性的患者結果，據記錄，6 個月時的通暢率為 89%，12 個月時為 86%。 OCT 引導的粥樣斑塊切除術實現了 84% 的獨立管腔增益，在她的研究中，這些病變中有三分之二是 CTO。使用我們的 Avinger CTO 穿越設備，我們稱之為 Ocelot，獨立的真正流明穿越在 95% 或 95% 的時間內實現。 Broadmann 博士的演講還證明了我們的研究數據的一致性。

Now, it's very, very important I think in this space, at 6 months, freedom from TLR of 94% closely matched in her study, closely matched our VISION six-month results of 92%; and freedom from TLR at 12 months 88% was -- also approximates the VISION 12-month interim results of 86%. So, in addition, Dr. Broadmann's study demonstrated statistically significant improvement in ABIs from baseline to both 6 and 12 months.

現在，我認為在這個領域非常非常重要，在 6 個月時，94% 的無 TLR 與她的研究非常匹配，與我們 VISION 6 個月的結果 92% 非常匹配； 88% 的 12 個月無 TLR 也接近 VISION 86% 的 12 個月中期結果。因此，除此之外，Broadmann 博士的研究表明，從基線到 6 個月和 12 個月，ABI 都有統計學意義的顯著改善。

So, looking ahead, we continue to be excited about pursuing the addition of in-stent restenosis client for Pantheris. As a reminder and unlike the other directional atherectomy device on the market, Pantheris is not contraindicated for ISR and we're optimistic about Pantheris' potential role in this area. We're planning to submit an IND for this study in the coming months.

因此，展望未來，我們繼續為 Pantheris 尋求增加支架內再狹窄客戶而感到興奮。提醒一下，與市場上其他定向旋切術設備不同，Pantheris 並不是 ISR 的禁忌症，我們對 Pantheris 在這一領域的潛在作用持樂觀態度。我們計劃在未來幾個月內為這項研究提交 IND。

So, in summary, I'm really happy with the clinical outcomes that we've generated to-date with the Pantheris, also I'd like to comment on the pipeline that we have in the R&D group, and I remain fully confident that image-guided therapy, which we call Lumivascular, will ultimately have really large impact on our space.

所以，總而言之，我對我們迄今為止與 Pantheris 產生的臨床結果非常滿意，我也想評論一下我們在研發團隊中的管道，我仍然完全相信圖像引導療法，我們稱之為 Lumivascular，最終將對我們的空間產生非常大的影響。

So, with that I'll turn the call over to Matt.

所以，我會把電話轉給馬特。

OK, thank you, John.

好的，謝謝你，約翰。

Total revenue for the fourth quarter ended December 31, 2016 was $4.7 million, a 64% increase from the fourth quarter of 2015 and the 12% decrease from the third quarter of 2016. Revenue related to Lightbox imaging consoles was $1 million, a 17% decrease compared to the fourth quarter of 2015 and a 29% decrease from the third quarter of 2016.

截至 2016 年 12 月 31 日的第四季度總收入為 470 萬美元，較 2015 年第四季度增長 64%，較 2016 年第三季度下降 12%。與 Lightbox 影像控制台相關的收入為 100 萬美元，下降 17%與 2015 年第四季度相比下降，與 2016 年第三季度相比下降 29%。

There were eight purchased Lightboxes during the quarter, two of which were sold to international distributors and there were seven net accounts that acquired a Lightbox through our rental or placement to purchase programs. Revenue from disposable devices was $3.7 million for the fourth quarter of 2016, a 118% increase compared to the fourth quarter of 2015 and a 5% decrease from the third quarter of 2016.

本季度有八個購買的燈箱，其中兩個賣給了國際分銷商，並且有七個淨帳戶通過我們的租賃或安置購買計劃獲得了一個燈箱。 2016 年第四季度來自一次性設備的收入為 370 萬美元，比 2015 年第四季度增長 118%，比 2016 年第三季度下降 5%。

Gross margin for the fourth quarter of 2016 was 21%, down from 37% in the comparable quarter of 2015 and down from 30% in the third quarter of 2016. The year-over-year decrease was primarily attributable to the growth of the company's manufacturing infrastructure associated with the commercial launch of Pantheris and the higher proportion of Lumivascular accounts participating in the company's placement to purchase and rental programs. The decrease compared to the third quarter of 2016 related primarily to a decrease in average selling price for Lightbox imaging consoles. Gross margin for the fourth quarter was also negatively impacted by higher costs related to product warranties and excess and obsolete inventories.

2016 年第四季度毛利率為 21%，低於 2015 年同期的 37%，低於 2016 年第三季度的 30%。同比下降主要是由於公司業務的增長與 Pantheris 的商業發布相關的製造基礎設施以及參與公司配售購買和租賃計劃的 Lumivascular 客戶比例較高。與 2016 年第三季度相比的下降主要與 Lightbox 影像控制台的平均售價下降有關。第四季度的毛利率也受到與產品保修以及過剩和過時庫存相關的更高成本的負面影響。

Operating expenses for the fourth quarter of 2016 were $12.9 million, compared to $13.4 million in the fourth quarter of 2015. This decrease was primarily attributable to higher sales and marketing expenses in 2015, as the Company expanded commercial organization in anticipation of the commercial launch of Pantheris.

2016 年第四季度的運營費用為 1290 萬美元，而 2015 年第四季度為 1340 萬美元。這一減少主要是由於 2015 年銷售和營銷費用增加，因為公司擴大了商業組織以預期商業推出黑豹。

Loss from operations for the fourth quarter of 2016 was $12 million, compared to $12.3 million for the fourth quarter of 2015. And net loss for the fourth quarter of 2016 was $13.5 million, which was consistent with the fourth quarter of 2015.

2016 年第四季度運營虧損為 1200 萬美元，而 2015 年第四季度為 1230 萬美元。2016 年第四季度淨虧損為 1350 萬美元，與 2015 年第四季度持平。

Loss per share for the fourth quarter of 2016 was $0.58, compared to $1.07 for the fourth quarter of 2015. The decreased loss per share includes the impact of the issuance of 9.9 million shares in the Company's follow-on public offering which closed on August 16, 2016, and 1.1 million shares issued throughout 2016 under the company's at the market, or ATM, public offering program.

2016 年第四季度每股虧損為 0.58 美元，而 2015 年第四季度為 1.07 美元。每股虧損減少包括公司在 8 月 16 日結束的後續公開發行中發行 990 萬股股票的影響，2016 年，以及 2016 年全年根據公司在市場上或 ATM 公開發行計劃發行的 110 萬股股票。

Adjusted EBITDA, a non-GAAP measure, was a loss of $9.5 million for the fourth quarter of 2016, compared to a loss of $9.8 million for the fourth quarter of 2015.

調整後的 EBITDA 是一項非 GAAP 指標，2016 年第四季度虧損 950 萬美元，而 2015 年第四季度虧損 980 萬美元。

Now, looking briefly at our full year 2016 results.

現在，簡要回顧一下我們 2016 年全年的業績。

Total revenue was $19.2 for 2016, a 79% increase from 2015. Lightbox imaging console revenues were $4.7 million, a 15% increase compared to 2015, and revenues from disposable devices were $14.5 million, a 120% increase compared to 2015. Revenue growth for 2016 reflects the launch of Pantheris during the first quarter of the year.

2016 年總收入為 19.2 美元，比 2015 年增長 79%。Lightbox 影像控制台收入為 470 萬美元，比 2015 年增長 15%，一次性設備收入為 1450 萬美元，比 2015 年增長 120%。 2016 年反映了 Pantheris 在今年第一季度的推出。

Gross margin for 2016 was 25%, down from 40% in 2015. The decrease was primarily attributable to the growth in manufacturing infrastructure in conjunction with the launch of Pantheris and higher costs related to product warranties and excess and obsolete inventories.

2016 年的毛利率為 25%，低於 2015 年的 40%。下降的主要原因是製造基礎設施的增長以及 Pantheris 的推出以及與產品保修和過剩和過時庫存相關的成本增加。

Operating expenses for the 2016 were $55.5 million, compared to $44.9 million in 2015. This growth was primarily attributable to Pantheris development expense and expansion of the Company's commercial organization.

2016 年的運營費用為 5550 萬美元，而 2015 年為 4490 萬美元。這一增長主要歸因於 Pantheris 開發費用和公司商業組織的擴張。

Loss from operations for 2016 was $50.7 million compared to $40.7 million for 2015.

2016 年的運營虧損為 5070 萬美元，而 2015 年為 4070 萬美元。

Loss per share for 2016 was $3.39 compared to $4.38 in 2015.

2016 年每股虧損為 3.39 美元，而 2015 年為 4.38 美元。

Adjusted EBITDA for the year was a loss of $41.8 million for 2016 compared to a $33.5 million loss for 2015.

2016 年全年調整後 EBITDA 虧損 4180 萬美元，而 2015 年虧損 3350 萬美元。

Turning now to our balance sheet. Cash and cash equivalents totaled $36.1 million as of December 31, 2016 compared to $43.1 million as of December 31, 2015 and $43.3 million as of September 30, 2016.

現在轉向我們的資產負債表。截至2016年12月31日，現金及現金等價物總計3610萬美元，截至2015年12月31日為4310萬美元，截至2016年9月30日為4330萬美元。

The net cash decrease during the fourth quarter $7.2 million, reflects cash expenditures of $11 million partially offset by $3.8 million in net proceeds from the sales of common stock under the Company's ATM program. Lastly, total debt at yearend was $41.3 million.

第四季度淨現金減少 720 萬美元，反映了 1100 萬美元的現金支出被公司 ATM 計劃下出售普通股的 380 萬美元淨收益部分抵消。最後，年底的總債務為 4130 萬美元。

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。

Looking ahead, we're working diligently to ready the Company for the launch of our new products while we continue to expand adoption of our Lumivascular platform and drive utilization of our current devices.

展望未來，我們正在努力工作，為公司推出我們的新產品做好準備，同時我們繼續擴大我們的 Lumivascular 平台的採用並推動我們現有設備的利用率。

As a reminder of our key upcoming milestones, we plan to file for 510(k) clearance for the next generation of Pantheris in mid 2017, and we plan to file for 510(k) clearance of our below-the-knee atherectomy device in the third quarter of 2017. We also plan to release 24-month follow-up data on the complete VISION population by the end of second quarter, and we also plan to submit an IDE application for an ISR study in the next two to three months and expect to begin enrollment once necessary approvals are in place.

作為我們即將到來的關鍵里程碑的提醒，我們計劃在 2017 年年中為下一代 Pantheris 申請 510(k) 許可，我們計劃在2017年第三季度。我們還計劃在第二季度末發布完整VISION人口的24個月隨訪數據，我們還計劃在未來兩到三個月內提交ISR研究的IDE申請並期望在必要的批准到位後開始註冊。

We look forward to updating you on our progress in the coming months. And with those comments, we like to open the call to your questions.

我們期待著在未來幾個月向您通報我們的進展情況。有了這些評論，我們想打開您的問題的電話。

Thank you. (Operator Instructions)

謝謝。 （操作員說明）

And our first question comes from Chris Cooley from Stephens. Your line is open.

我們的第一個問題來自 Stephens 的 Chris Cooley。你的線路是開放的。

Good afternoon, gentlemen. Thanks for taking the questions. Just two from me, and then I'll hop back in queue.

下午好，先生們。感謝您提出問題。只有我兩個，然後我會跳回隊列。

When we look at the regulatory timeline for Pantheris and maybe -- I just want to make sure I'm on the same page. It looks like timelines pretty much across the board have slid by about a quarter, if I remember back to the prior 3Q call? And I just wanted to one, confirm that that was in fact the case?

當我們查看 Pantheris 的監管時間表時，也許——我只是想確保我在同一頁面上。如果我記得回到之前的 3Q 電話會議，看起來時間線幾乎全面下滑了大約四分之一？我只是想確認事實確實如此？

And two, maybe get a little bit more clarity around that slippage, if in fact that's correct. So, I had you down for the next gen Pantheris to be [filing] the 510(k) in the 1Q and the below-the-knee device at the 510(k) filing mid-'17 and on the ISR indication hoping to start the trial actually during the first half. So, it sounds like we're just on the line on all three of those. But, I just want to make sure I understand the basis for that.

第二，如果這確實是正確的話，也許可以更清楚地了解這一滑點。所以，我讓你失望了下一代 Pantheris 將在 1Q 中[提交] 510(k)，在 17 年中期提交 510(k) 的膝蓋以下設備以及 ISR 指示希望實際上在上半場開始審判。所以，聽起來我們在所有這三個方面都處於危險之中。但是，我只是想確保我了解其基礎。

And then I've got one quick follow-up. Thank you.

然後我有一個快速跟進。謝謝。

OK, yes, Chris, on the next generation of Pantheris, we had anticipated Q2. And as we have our current timelines, we are looking at that -- the latter part of Q2, early Q3 [while we've kind of] revised that to mid-2017 as we get further along in our final verification and validation. So, we wanted to make sure that we were representing properly where that is. So, there is a good chance that might push into the early third quarter, so a slight revision there.

好的，是的，克里斯，關於下一代 Pantheris，我們已經預料到了第二季度。根據我們當前的時間表，我們正在考慮這一點——第二季度末，第三季度初 [雖然我們有點] 將其修改為 2017 年年中，因為我們在最終驗證和驗證中取得了進一步進展。所以，我們想確保我們正確地代表了它所在的位置。因此，很有可能會推遲到第三季度初，因此會有輕微的修正。

As we look at the below-the-knee device, we had always been thinking early Q3 on that device, which was consistent with the mid-2017 timing.

當我們查看膝下設備時，我們一直在考慮該設備的第三季度初，這與 2017 年年中的時間一致。

But again, we're giving ourselves little time there, because one of the things that we've done -- as I think we've talked about in the past calls -- is we have made our verification, validation, testing and protocols tougher, a little more comprehensive, because we want to make sure we're avoiding any potential quality issues prior to launch. So, we want to take the time to make sure that we've these products right. We're very, very happy with the development programs that we're moving forward. We've also pulled certain of the improvements that will be in 1.4 earlier in -- or in our -- I'm sorry in the next generation of Pantheris into our current device.

但同樣，我們在那裡給自己的時間很少，因為我們所做的其中一件事——正如我認為我們在過去的電話會議中談到的那樣——是我們已經完成了驗證、驗證、測試和協議更嚴格、更全面，因為我們想確保在發布之前避免任何潛在的質量問題。因此，我們想花時間確保我們擁有正確的這些產品。我們對我們正在推進的開發計劃非常非常滿意。我們還把 1.4 早期的某些改進——或者我們的——很抱歉，在下一代 Pantheris 中引入了我們當前的設備。

So, we'll be rolling out this quarter and next quarter certain improvements related to the inflation system, related to the nosecone on our current device that will also be incorporated into the next generation device. So, that does delay the timeframe a little bit on the next gen device. But we thought that it was important to make those improvements that we could under a letter to file regulatory approach and start rolling them into the market and then of course add a number of other improvements into our next generation Pantheris, which of course we'll launch sometime in the latter part of the year given the filing timeframe. So, a little bit of taking some of those improvements earlier than we originally anticipated.

因此，我們將在本季度和下個季度推出與充氣系統相關的某些改進，這些改進與我們當前設備上的鼻錐相關，也將被納入下一代設備。因此，這確實會稍微延遲下一代設備的時間範圍。但我們認為，重要的是進行這些改進，我們可以通過信函提交監管方法並開始將它們推向市場，然後當然會在我們的下一代 Pantheris 中添加一些其他改進，我們當然會考慮到申請時間框架，將在今年下半年的某個時候推出。因此，比我們最初預期的要早一些進行這些改進。

And then, the below-the-knee device is pretty much on track, where we had anticipated it to be.

然後，膝蓋以下的設備幾乎步入正軌，正如我們預期的那樣。

As far as the IDE application, we're on track to file that IDE application; we anticipate by early Q2, and it really just is a matter of when we get approval -- get IRB approval -- and are we able to start enrollment, which obviously we can control the submission timing but we can't necessarily control the feedback timing.

至於 IDE 應用程序，我們正按計劃提交該 IDE 應用程序；我們預計在第二季度初，這實際上只是我們何時獲得批准的問題——獲得 IRB 批准——以及我們是否能夠開始註冊，這顯然我們可以控制提交時間，但我們不一定能控制反饋定時。

Understood. I appreciate the additional color, and that makes perfect sense on pulling forward one quarter to make the current generation little bit more robust.

明白了。我很欣賞額外的顏色，這對於向前推進四分之一以使當前一代更強大一點來說是非常有意義的。

My other question pertains to the change from a sales and marketing leadership standpoint. I just have -- I guess very directly, I've never seen six different heads before in this short of a window. And I was hoping you could address maybe the application process in terms of how you're identifying candidates, what you're looking for in those candidates? And then maybe how that individual's role is within the company -- so that, as we think on a go-forward basis, how to get some consistency here going forward from a head of sales and marketing perspective?

我的另一個問題是從銷售和營銷領導的角度來看的變化。我只是 - 我猜得非常直接，我以前從未在這麼短的窗口中看到過六個不同的頭像。我希望您可以根據您如何確定候選人以及您在這些候選人中尋找什麼來解決申請流程？然後也許這個人在公司中的角色是什麼——所以，正如我們在前進的基礎上思考的那樣，如何從銷售和營銷負責人的角度在這裡獲得一些一致性？

Thank you.

謝謝。

Yes, and so, from a change perspective, obviously JD who's been with the Company almost since the beginning -- over eight years in a variety of roles, and he had been in this role since mid or July 2016 last year, a relatively brief tenure -- he made the decision that it was not something that he wanted to continue to pursue in the near- or long-term, and that his desire is to explore other opportunities outside the Company, perhaps the opportunity to lead an entire organization.

是的，所以，從變化的角度來看，顯然 JD 幾乎從一開始就在公司工作——擔任各種職務超過 8 年，他從去年 2016 年中旬或 7 月開始擔任這個職務，時間相對較短任期——他做出的決定是他不想在短期或長期繼續追求，他的願望是探索公司以外的其他機會，也許是領導整個組織的機會。

As far as I know, and based on my conversations with him, he's not identified any opportunities. But, this was a decision he made after aggressively pursuing that role, going into the back half of the year.

據我所知，根據我與他的談話，他沒有發現任何機會。但是，這是他在積極追求這個角色後做出的決定，進入了下半年。

So, as we look at that near end, I really believe long-term, we have identified and promoted earlier in the year in January, two of our most experienced sales directors to area of VPs for the east and the west. And without planned continued expansion of our sales force as we are waiting for the new products to be developed and launched, we do not plan to fill that SVP role.

因此，當我們看到這一點時，我真的相信長期來看，我們已經在今年 1 月份的早些時候確定並提拔了我們最有經驗的兩名銷售總監，擔任東部和西部地區的副總裁。由於我們正在等待開發和推出新產品，因此沒有計劃繼續擴大我們的銷售隊伍，我們不打算填補該高級副總裁的角色。

These area VPs had reported directly to me before when they were regional sales directors. Also, our VP of Marketing has been with the company for over four years, very strong experienced guy, all the way back from Fox Hollow days, and he has reported to me directly before as well.

這些區域副總裁在擔任區域銷售總監之前直接向我匯報。此外，我們的營銷副總裁已經在公司工作了四年多，是一位非常有經驗的人，從 Fox Hollow 時代一直回來，他之前也直接向我匯報過。

So, we are going to take this as an opportunity to bring some more efficiency to our sales organization. I think we have strong leadership in place that's very connected with the day to day, and it does enable me to get closer to the commercial activities. So, the answer is we feel that this has been a challenging position. We think we have a really good level of management that's more directly related to what's going on, on the ground. And I am excited about working directly with those folks on a go forward basis.

因此，我們將以此為契機，為我們的銷售組織帶來更多效率。我認為我們擁有與日常工作密切相關的強有力的領導，這確實讓我能夠更接近商業活動。所以，答案是我們認為這是一個具有挑戰性的職位。我們認為我們的管理水平非常好，與當地發生的事情更直接相關。我很高興能在前進的基礎上直接與這些人合作。

Thank you, I appreciate it.

謝謝你，我很感激。

And our next question comes from Jason Mills from Canaccord. Your line is open.

我們的下一個問題來自 Canaccord 的 Jason Mills。你的線路是開放的。

Hi, this is actually Cecilia on for Jason.

嗨，這實際上是傑森的塞西莉亞。

And I just wanted to ask a little bit about what you are seeing currently in the market, the play between DCB platforms, driving atherectomy volume and just any changes to your selling strategy that you have implemented in this current market?

我只是想問一下您目前在市場上看到的情況、DCB 平台之間的作用、推動斑塊切除術的數量以及您在當前市場中實施的銷售策略有何變化？

[Sure], I'll ask Dr. Simpson to comment a little bit. But, when we look at what's happening in the market -- and I think we've talked about before, Cecilia -- there is a real interest and sincere belief in the clinical community in the kind of ideal combination of de-bulking of vessel and significantly de-bulking of vessel as you can with directional atherectomy prior to application of a drug coated balloon. A fundamental premise of what we are all about here at Avinger is to provide important real time information to the clinician so that they are empowered to make the decision that they feel they are best to their patients; that has not changed.

[當然]，我會請辛普森博士發表一些評論。但是，當我們看看市場上發生的事情時——我想我們之前已經談過，塞西莉亞——臨床社區對血管減積的理想組合有真正的興趣和真誠的信念並在應用藥物塗層球囊之前通過定向粥樣斑塊切除術顯著減少血管體積。我們在 Avinger 所做的一切的一個基本前提是向臨床醫生提供重要的實時信息，以便他們能夠做出他們認為對患者最好的決定；這沒有改變。

We also believe it's important to provide precision of control and visibility, so that they can provide effective treatment broad luminal gain without damaging the healthy arterial structures, which has been proven in our clinical studies and another studies as well to be directly related to limiting restenosis.

我們還認為，提供精確的控制和可見性非常重要，這樣它們就可以提供有效的治療，擴大管腔增益，而不會損害健康的動脈結構，這在我們的臨床研究和其他研究中已經證明與限制再狹窄直接相關.

So clearly, we have had excellent standalone results. We continue to see a significant amount of DCB usage following treatment with Pantheris and we see outstanding results there as well.

很明顯，我們取得了出色的獨立結果。在用 Pantheris 治療後，我們繼續看到大量的 DCB 使用，我們也看到了顯著的結果。

But our strategy from a commercial standpoint is to provide information, to empower the physicians to make their own decisions. But I certainly invite you, Dr. Simpson, to add your perspective on this interplay.

但從商業角度來看，我們的策略是提供信息，讓醫生能夠做出自己的決定。但我當然邀請您，辛普森博士，發表您對這種相互作用的看法。

Yes, I agree. I think you stated really clearly.

是的我同意。我覺得你說的很清楚。

I mean, we think that Pantheris standalone is, I probably personally think, best of best choice if you can get great results [as you graph again] by OCT. But we certainly see a lot of the DCB used as well in conjunction. DCBs by themselves have had very disappointing results, so they need -- they already prepared, let's say, in a way for them to have the best chance of reducing recurrence of TLRs. And so, I think it's Pantheris and DCB is a really good combination if you want to use DCB, if you want to use Pantheris ling enough, certainly that is an option.

我的意思是，我們認為 Pantheris standalone 是，我可能個人認為，如果你能通過 OCT 獲得很好的結果 [當你再次繪製圖表時] 是最好的選擇。但我們確實看到很多 DCB 也被結合使用。 DCB 本身的結果非常令人失望，因此他們需要——比方說，他們已經做好了準備，讓他們有最好的機會減少 TLR 的複發。因此，我認為 Pantheris 和 DCB 是一個非常好的組合，如果你想使用 DCB，如果你想充分使用 Pantheris ling，那當然是一個選擇。

OK, thank you very much for the color.

好的，非常感謝你的顏色。

And then, just one follow-up. I know you haven't provided guidance, but just around account growth expectations for 2017 and just how we should think about either the VA contracts, the placement to purchase model, rental program -- just kind of how you're thinking about this right now?

然後，只有一個跟進。我知道你沒有提供指導，但只是圍繞 2017 年的賬戶增長預期以及我們應該如何考慮 VA 合同、購買模型、租賃計劃的安排——就像你對這個的思考方式一樣正確現在？

Thank you.

謝謝。

OK, sure, Cecilia. So, as we look at building the installed base, again we'll provide more specific guidance by our first quarter call, but we're really pleased with the amount of new account adoption that we've been driving through 2016. We think that's a good pace.

好的，當然，塞西莉亞。因此，當我們著眼於建立安裝基礎時，我們將在第一季度電話會議上再次提供更具體的指導，但我們對 2016 年推動的新客戶採用量感到非常滿意。我們認為這是一個很好的節奏。

Our focus is on driving utilization, bringing in new users within current accounts, driving utilization within new accounts. And in mid 2015, we introduced a more -- as you might remember -- a more flexible capital acquisition model, which enables us to have a more productive and quicker, I guess, dialogue with our customers to get Lumivascular installed for physicians who want to use it and to provide that very important clinical case experience, even as part of an evaluation process, which we're really confident in. So, we're going to continue on that model. We think that part of our business is working well.

我們的重點是提高利用率，在現有賬戶中引入新用戶，在新賬戶中提高利用率。在 2015 年年中，我們推出了一種更靈活的資本收購模式，您可能還記得，這使我們能夠更高效、更快速地與我們的客戶進行對話，以便為需要的醫生安裝 Lumivascular使用它並提供非常重要的臨床案例經驗，甚至作為評估過程的一部分，我們對此非常有信心。因此，我們將繼續使用該模型。我們認為我們的部分業務運作良好。

We continue to sell Lightboxes; convert Lightboxes that have been placed, sell Lightboxes right out of the gates in some cases. But I would expect a similar kind of account adoption pace through this year. But we'll give more specific guidance as we -- by our first quarter call.

我們繼續銷售燈箱；轉換已放置的燈箱，在某些情況下立即出售燈箱。但我預計今年會出現類似的帳戶採用速度。但是我們會在第一季度電話會議上給出更具體的指導。

(Operator Instructions)

（操作員說明）

And our next question comes from Steven Lichtman with Oppenheimer. Your line is open.

我們的下一個問題來自 Steven Lichtman 和 Oppenheimer。你的線路是開放的。

Hi, guys, it's Dennis in for Steve.

嗨，伙計們，史蒂夫是丹尼斯。

Just two questions, the first is for Matt on the gross margin commentary. Wondering if you could talk a little more about what the product warranties are related to and if you could give us a sense of what they were in the quarter and when would that expense start coming down.

只有兩個問題，第一個是馬特對毛利率的評論。想知道您是否可以多談談與產品保修相關的內容，以及您是否可以讓我們了解他們在本季度的情況以及該費用何時開始下降。

Yes, so, in terms of gross margins, we've talked quite a bit about some of the reliability issues with Pantheris since it launched, and that has translated to a higher level of returns. And so that really is the main driver of higher than planned warranty expense.

是的，所以，就毛利率而言，自 Pantheris 推出以來，我們已經談了很多可靠性問題，這已經轉化為更高水平的回報。因此，這確實是導致保修費用高於計劃的主要原因。

We think we've gotten that under control pretty well but we would expect to continue to have it be higher than we really want it to be for the next couple of quarters until we can get some of these improvements in place. And those will be both, some of the incremental improvements that will be coming out sooner and then the next generation of Pantheris, which is more of a wholesale upgrade of the device later in the year.

我們認為我們已經很好地控制了它，但我們預計在接下來的幾個季度中它會繼續高於我們真正希望的水平，直到我們能夠實現其中的一些改進。這些都將是兩者，一些增量改進將很快出現，然後是下一代 Pantheris，它更像是今年晚些時候對該設備的全面升級。

So that's the main driver. Nothing having to do with any kind of safety related issues -- more kind of minor annoyance factors. But we are very willing to replace a product that doesn't perform completely up to our own standards and the expectations of our customers.

所以這是主要的驅動因素。與任何類型的安全相關問題無關——更多的是輕微的煩惱因素。但我們非常願意更換性能不完全符合我們自己的標準和客戶期望的產品。

And, I think during the quarter, we did have one situation where we actually had to replace the Lightbox, which is I think the only situation where we had to do that in the Company's history, but it's certainly a bigger ticket item, which had some impact on that overall number. So, I can't remember if there was another part of your question but that's sort of the basic gist of it.

而且，我認為在本季度，我們確實遇到過一種情況，我們實際上不得不更換燈箱，我認為這是公司歷史上我們必須這樣做的唯一情況，但它肯定是一個更大的門票項目，它有對總人數有一些影響。所以，我不記得你的問題是否還有另一部分，但這是它的基本要點。

Great, I appreciate that. I just had one follow-up on the pipeline.

太好了，我很感激。我剛剛進行了一項後續工作。

Any sense for when you get an approval decision on next gen and also in below-the-knee?

當您獲得關於下一代和膝蓋以下的批准決定時，有什麼意義嗎？

Typically our average approval -- our average time to approval from filing a 510(k) has been extremely good here, either at or before the 90 days. And our own internal timelines, we tend to think about 120-day timing, 90-day for review of a traditional 510(k).

通常我們的平均批准——我們從提交 510(k) 到批准的平均時間在這裡非常好，無論是在 90 天還是之前。而我們自己的內部時間表，我們傾向於考慮 120 天的時間安排，90 天的時間來審查傳統的 510(k)。

And we believe that both the next gen product and the below-the-knee device will be traditional 510(k) and then an incremental 30 days for questions back and forth. Of course, there isn't real predictability around that other than to say that we've been on average under that 90 days for our very -- several 510(k) filings that we've made here as a company.

我們相信下一代產品和膝下設備都將是傳統的 510(k)，然後增加 30 天來回提問。當然，除了說我們作為一家公司在這裡提交的幾份 510(k) 文件平均不到 90 天之外，並沒有真正的可預測性。

So, great track record, great relationship with FDA and a lot of experience built working on it. So, I think for just planning purposes and timing purposes, I think to think of 90 to 120 days from filing.

因此，良好的業績記錄、與 FDA 的良好關係以及在這方面積累的大量經驗。因此，我認為僅出於計劃目的和時間安排目的，我想考慮從提交開始算起的 90 到 120 天。

And at this time I'm showing no further questions. I would like to turn the call back over to Jeff Soinski for any closing remarks.

此時我沒有再提出任何問題。我想將電話轉回給 Jeff Soinski 以聽取任何結束語。

Well, thank you all very much for joining our call this afternoon. Of course, we appreciate your continued interest in our company. We look forward to updating you on our progress when we report first quarter results. Thank you.

非常感謝大家今天下午加入我們的電話會議。當然，我們感謝您對我們公司的持續關注。我們期待在報告第一季度業績時向您通報我們的進展情況。謝謝。

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect. Everyone have a great day.

女士們，先生們，感謝你們參加今天的會議。程序到此結束。您現在可以斷開連接。每個人都有美好的一天。