Avinger Inc (AVGR) 2018 Q1 法說會逐字稿

Greetings and welcome to Avinger's 2018 First Quarter Conference Call.

歡迎來到 Avinger 2018 年第一季度電話會議。

(Operator Instructions) I'll remind you that this conference is being recorded.

（操作員說明）我會提醒您，正在錄製此會議。

It is now my pleasure to introduce Mr. [Chris Kamara], Director of Client Communications at Earth Communications.

現在我很高興向大家介紹 Earth Communications 的客戶傳播總監 [Chris Kamara] 先生。

Mr. [Kamara], you may begin.

[Kamara] 先生，您可以開始了。

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

謝謝大家，也感謝大家參加今天的電話會議。

I'd like to welcome all of you to Avinger's First Quarter 2018 Conference Call.

歡迎大家參加 Avinger 2018 年第一季度電話會議。

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 first quarter ended March 31, 2018.

今天早些時候，Avinger 發布了截至 2018 年 3 月 31 日的第一季度財務業績。

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 the 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《私人證券訴訟改革法》的安全港條款作出的1995 年。

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, are future financial expectations, are based on current estimates and various assumptions.

所有前瞻性陳述，包括但不限於未來財務預期，均基於當前估計和各種假設。

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 of -- and description of the risks and uncertainties associated with the business, please see the filings with the Securities and Exchange Commission.

有關與業務相關的風險和不確定性的列表和描述，請參閱提交給美國證券交易委員會的文件。

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, Chris.

謝謝，克里斯。

Good afternoon, and thank you all for joining us.

下午好，感謝大家加入我們。

Avinger has made significant headway during the first quarter, and we're excited about the opportunity to share it with you.

Avinger 在第一季度取得了重大進展，我們很高興有機會與您分享。

I'll briefly touch on the financial transactions we completed during the quarter that have reduced debt and given us the capital we need to focus on upcoming anticipated FDA clearances and commercial launch of our 2 next-generation Pantheris image-guided atherectomy devices this year.

我將簡要介紹一下我們在本季度完成的金融交易，這些交易減少了債務，並為我們提供了資金，我們需要專注於即將到來的預期 FDA 批准和今年我們的 2 款下一代 Pantheris 圖像引導斑塊切除術設備的商業發布。

Later in the call, Matt will cover these transactions in greater depth as well as discuss our first quarter 2018 financial results.

在電話會議的後期，馬特將更深入地介紹這些交易，並討論我們 2018 年第一季度的財務業績。

Improving our financial position is just one of the steps we've taken to achieve a significant turnaround of the company.

改善我們的財務狀況只是我們為實現公司重大轉機所採取的步驟之一。

Avinger is an emerging commercial-stage medical device company that designs and develops the first-ever image-guided catheter-based system for the diagnosis and treatment of patients with peripheral artery disease, or PAD.

Avinger 是一家新興的商業階段醫療設備公司，設計和開發了有史以來第一個基於圖像引導的導管系統，用於診斷和治療外周動脈疾病 (PAD) 患者。

We believe our Lumivascular technology has the potential to improve the standard of care for the millions of patients that suffer from this disease.

我們相信我們的 Lumivascular 技術有可能提高數百萬患有這種疾病的患者的護理標準。

We've made significant progress in product development, regulatory affairs, continued cost cutting, as well as driving utilization of our existing products.

我們在產品開發、監管事務、持續削減成本以及推動現有產品的利用率方面取得了重大進展。

We had -- have a number of important milestones still to come this year, and we believe we're well positioned for growth in the second half of the year.

我們有 - 今年還有許多重要的里程碑，我們相信我們為今年下半年的增長做好了準備。

As a reminder, Avinger has developed the only technology in the world that provides real-time visualization inside the artery during the treatment of PAD.

提醒一下，Avinger 開發了世界上唯一一種在 PAD 治療期間提供動脈內部實時可視化的技術。

PAD is a narrowing of the arteries away from the heart and is most commonly diagnosed and treated in the arteries of the pelvis and legs.

PAD 是遠離心臟的動脈變窄，最常在骨盆和腿部的動脈中被診斷和治療。

Our Lumivascular platform provides physicians a clear picture of the artery during treatment, enabling them to better differentiate between plaque and healthy arterial structures, thereby helping them avoid damage to the healthy portions of an artery.

我們的 Lumivascular 平台為醫生提供了治療期間動脈的清晰圖像，使他們能夠更好地區分斑塊和健康的動脈結構，從而幫助他們避免對動脈的健康部分造成損害。

Our clinical studies and real-world clinical experience have shown that by empowering physicians to precisely target disease and avoid damaging the healthy artery, we can provide an extremely positive safety profile and excellent long-term clinical outcomes.

我們的臨床研究和真實世界的臨床經驗表明，通過使醫生能夠精確定位疾病並避免損害健康動脈，我們可以提供極其積極的安全狀況和出色的長期臨床結果。

Currently, our product pipeline consists of 5 central products in various phases of development and commercialization.

目前，我們的產品線包括 5 個處於不同開發和商業化階段的核心產品。

In addition to our FDA-approved Pantheris image-guided atherectomy device, we offer the FDA-approved Ocelot family of image-guided CTO-crossing catheters.

除了我們經 FDA 批准的 Pantheris 圖像引導粥樣斑塊切除術設備外，我們還提供經 FDA 批准的 Ocelot 系列圖像引導 CTO 交叉導管。

For those of you new to Avinger or the peripheral space, CTO stands for chronic total occlusion, which is used to refer to a completely blocked artery.

對於剛接觸 Avinger 或周圍空間的人來說，CTO 代表慢性完全閉塞，用於指代完全阻塞的動脈。

A CTO-crossing device is used to create a passage through a blocked artery so that a guidewire can be introduced and further treatment can be provided.

CTO 穿越裝置用於創建一條穿過阻塞動脈的通道，以便可以引入導絲並提供進一步治療。

We're also developing a next-generation CTO crosser on the same technology platform used for Pantheris, which we call [Ocellaris].

我們還在用於 Pantheris 的同一技術平台上開發下一代 CTO crosser，我們稱之為 [Ocellaris]。

This device will be used in the peripheral arteries, but we believe it will also provide a strong foundation for the development of CTO-crossing devices for the coronary arteries.

該設備將用於外周動脈，但我們相信它也將為冠狀動脈 CTO 穿越設備的開發奠定堅實的基礎。

Coronary CTOs represent a substantial unmet medical need, and we believe our Lumivascular technology is ideally suited to address this need.

冠狀動脈 CTO 代表了大量未滿足的醫療需求，我們相信我們的 Lumivascular 技術非常適合滿足這一需求。

In addition to our new catheter programs, we're continuing to develop a next-generation Lightbox imaging console, which we call the [L300].

除了我們新的導管項目，我們還在繼續開發下一代 Lightbox 成像控制台，我們稱之為 [L300]。

This is an exciting product that will dramatically reduce the size of our imaging console and provide a variety of other benefits.

這是一款令人興奮的產品，它將顯著減小我們的成像控制台的尺寸並提供各種其他優勢。

We look forward to sharing additional details on the L300 on future calls.

我們期待在未來的通話中分享有關 L300 的更多詳細信息。

The company has made significant strides in our efforts to bring these limb and life-saving technologies into widespread commercialization.

該公司在將這些肢體和救生技術廣泛商業化方面取得了重大進展。

In January, we announced that Dr. Arne Schwindt, a vascular surgeon at St.

1 月，我們宣布 St.

Franziskus Hospital in Muenster, Germany, had successfully treated the first 7 patients with the next-generation Pantheris Lumivascular atherectomy system.

德國明斯特的 Franziskus 醫院使用下一代 Pantheris Lumivascular 粥樣斑塊切除術系統成功治療了首批 7 名患者。

Dr. Schwindt treated patients with a variety of lesion types, including in-stent restenosis, a calcified lesion and a chronic total occlusion.

Schwindt 醫生治療過多種病變類型的患者，包括支架內再狹窄、鈣化病變和慢性完全閉塞。

In each of the 7 cases, Pantheris performed as intended and Dr. Schwindt made note of the design features that enabled significant performance improvements as a comparative -- excuse me, as compared to previous versions of the device, including better directional control of the cutter blade for more precise atherectomy, a more robust nose cone and markers on the catheter shaft to facilitate longitudinal positioning.

在 7 個案例中的每一個案例中，Pantheris 都按預期進行，Schwindt 博士記下了能夠顯著提高性能的設計特徵作為比較——對不起，與該設備的以前版本相比，包括更好的切割器方向控制刀片用於更精確的粥樣斑塊切除術、更堅固的鼻錐和導管軸上的標記以促進縱向定位。

In the months following these initial treatments, our physician customers in Europe continue to report outstanding clinical results in a variety of anatomies and lesion types.

在這些初步治療後的幾個月裡，我們在歐洲的醫生客戶繼續報告各種解剖結構和病變類型的出色臨床結果。

We believe this early experience in Europe bodes well for the adoption of the next-generation Pantheris catheter in the U.S. once the device is cleared by the FDA.

我們相信，一旦該設備獲得 FDA 批准，歐洲的這一早期經驗預示著美國將採用下一代 Pantheris 導管。

As we stated on our last call, we continue to expect to receive FDA clearance and launch the next-generation Pantheris in the U.S. accounts this quarter.

正如我們在上次電話會議上所說，我們繼續期望本季度能獲得 FDA 的批准並在美國推出下一代 Pantheris。

As is typically the case with 510(k) filings, we received some questions and requests for data following our initial submission.

與 510(k) 申請的典型情況一樣，我們在初次提交後收到了一些問題和數據請求。

We've now responded to all of these questions and are waiting to hear back from the agency.

我們現在已經回答了所有這些問題，正在等待該機構的回复。

In the meantime, we're building our initial inventory of the next-generation devices and plan to launch this device into initial sites in the U.S. immediately following FDA approval.

與此同時，我們正在構建下一代設備的初始庫存，併計劃在獲得 FDA 批准後立即將此設備投放到美國的初始站點。

We plan to expand distribution of the next-generation Pantheris throughout the remainder of the year as we increase production and gain purchasing approvals in additional Lumivascular sites.

我們計劃在今年剩餘時間內擴大下一代 Pantheris 的分銷，因為我們增加了產量並獲得了更多 Lumivascular 站點的採購批准。

In addition to the next-generation Pantheris, we also anticipate submitting a 510(k) application for clearance of a lower-profile six-French version of Pantheris for smaller vessels, including those below the knee, by the middle of this year.

除了下一代 Pantheris 之外，我們還預計在今年年中之前提交一份 510(k) 申請，以批准用於較小船隻（包括膝蓋以下的船隻）的低調六法式 Pantheris 版本。

We expect to receive our CE Marking for this new device around the same time we file our 510(k) submission 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 in the U.S. Based on our anticipated filing time line, we continue to expect 510(k) clearance and initial U.S. launch prior to the end of this year.

我們預計大約在我們在美國提交 510(k) 申請的同時獲得這款新設備的 CE 標誌，這與下一代 Pantheris 類似，將為這種新的較低的早期臨床體驗提供機會在美國提交申請後很快在歐洲推出 profile 設備。根據我們預期的申請時間線，我們繼續預計 510(k) 批准和在今年年底之前在美國首次推出。

We remain excited about the potential for the expansion of our Pantheris product line.

我們對擴大 Pantheris 產品線的潛力感到興奮。

In addition to the demonstrated health benefits of the device, we believe that our unique technology will quickly assert itself as a valuable solution in addressing this large and growing market.

除了該設備已證明的健康益處外，我們相信我們獨特的技術將很快成為應對這個龐大且不斷增長的市場的有價值的解決方案。

In fact, we estimate that this new device will expand our available market opportunity by as much as 50% and therefore, will also result in increased utilization by our customers.

事實上，我們估計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 our important product development activities, we continue to make progress on our INSIGHT IDE trial, our pivotal clinical study designed to evaluate the safety and effectiveness of Pantheris in treating in-stent restenosis, or ISR.

除了我們重要的產品開發活動外，我們還在 INSIGHT IDE 試驗中繼續取得進展，這是我們的關鍵臨床研究，旨在評估 Pantheris 在治療支架內再狹窄或 ISR 方面的安全性和有效性。

We're excited about Pantheris' potential role in treating these challenging lesions, which represent approximately 20% of PAD procedures in the U.S. We continue to open new sites for enrollment in the study and expect most of the enrollment in this trial to take place once the next-generation Pantheris is commercially available in the U.S.

我們對 Pantheris 在治療這些具有挑戰性的病變方面的潛在作用感到興奮，這些病變約占美國 PAD 程序的 20%。我們將繼續開設新的研究中心，並預計該試驗的大部分註冊將進行一次下一代 Pantheris 在美國上市

In order to enhance what we believe is already a strong value proposition, we remain committed to execution of our previously discussed reimbursement initiatives.

為了加強我們認為已經是一個強大的價值主張，我們仍然致力於執行我們之前討論過的報銷計劃。

We continue to expect to file an application for a new CPT code for OCT diagnostic reimbursement by the end of the current quarter.

我們繼續期望在本季度末提交新的 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，類似於目前在這種情況下為使用血管內超聲或 IVUS 提供的報銷。

While the FDA has already cleared OCT diagnostic claims for our Pantheris and Ocelot devices, we anticipate that the CPT application would be supported by a small-scale clinical trial called SCAN, which we're in the process of initiating here in the U.S. that compares 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 CPT 申請將得到名為 SCAN 的小規模臨床試驗的支持，我們正在美國這裡啟動該試驗，比較外周動脈 IVUS 的 OCT 診斷成像。

We expect any new diagnostic reimbursement to be incremental to the strong reimbursement currently in place for atherectomy procedures in the peripheral arteries, reimbursement for which our Pantheris device already qualifies.

我們希望任何新的診斷報銷都能增加目前外周動脈粥樣斑塊切除術的強大報銷，我們的 Pantheris 設備已經符合資格。

In summary, we're confident that we've taken the necessary steps to restructure and stabilize the company while establishing a fortified platform capable of supporting both near-term growth and long-term sustainability.

總之，我們相信我們已經採取了必要的步驟來重組和穩定公司，同時建立一個能夠支持近期增長和長期可持續性的強化平台。

I believe that the most difficult aspects of the turnaround are behind us and that the business will continue to trend upwards.

我相信，扭虧為盈最困難的方面已經過去，業務將繼續呈上升趨勢。

Avinger has a very bright future, and our entire team remains focused on leveraging the numerous opportunities that lay ahead of us as we strive to achieve our ultimate goal of improved utilization, increased market share and enhanced shareholder value.

Avinger 擁有非常光明的未來，我們的整個團隊仍然專注於利用擺在我們面前的眾多機會，因為我們努力實現提高利用率、增加市場份額和提高股東價值的最終目標。

I'll now ask Matt to give details about our recent financing transactions and our first quarter financial results.

我現在請馬特詳細介紹我們最近的融資交易和第一季度的財務業績。

Matt?

馬特？

Thank you, Jeff.

謝謝你，傑夫。

During the first quarter, we significantly strengthened our financial position, which has allowed us to focus on operations and our anticipated FDA clearance and product launches.

在第一季度，我們顯著增強了財務狀況，這使我們能夠專注於運營以及我們預期的 FDA 批准和產品發布。

In February 2018, we successfully completed a new equity raise with gross proceeds of $18 million.

2018 年 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 reduced our debt by 85% and leaves us with approximately $8.1 million of debt as of the end of Q1.

這使我們的債務減少了 85%，截至第一季度末，我們的債務約為 810 萬美元。

The equity offered includes 2 series of warrants, both with an exercise price of $2 per share.

所提供的股權包括 2 個系列的認股權證，均以每股 2 美元的行權價發行。

The Series 1 warrants expire in February 2025.

系列 1 認股權證將於 2025 年 2 月到期。

And the Series 2 warrants contain a feature providing that if they earn the money during the 60 days after we achieve FDA clearance of our six-French Pantheris, they would have to be exercised by that date.

系列 2 認股權證包含一項功能，即如果他們在我們獲得 FDA 對我們的六隻法國黑豹進行 FDA 批准後的 60 天內賺錢，則必須在該日期之前行使。

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

如果他們在 FDA 批准後的 60 天內還沒有賺到錢，他們的有效期將延長至 2025 年 2 月，與系列 1 認股權證相同。

As Jeff mentioned, we expect to receive FDA clearance for our six-French Pantheris 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 提到的，我們希望在今年年底之前獲得 FDA 對我們的 6 架法國 Pantheris 的許可，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。

Now turning to our financials.

現在轉向我們的財務狀況。

Total revenue was $1.8 million for the first quarter ended March 31, 2018, a 48% decrease from the first quarter of 2017 when the company had a much larger sales force.

截至 2018 年 3 月 31 日止第一季度的總收入為 180 萬美元，較 2017 年第一季度下降 48%，當時該公司的銷售隊伍規模大得多。

Revenue from disposable devices was $1.5 million for the quarter, a 49% decrease compared to the first quarter of 2017.

本季度一次性設備的收入為 150 萬美元，與 2017 年第一季度相比下降了 49%。

Revenue related to Lightbox imaging consoles was $0.3 million, a 45% decrease compared to the first quarter of 2017.

與 Lightbox 影像控制台相關的收入為 30 萬美元，與 2017 年第一季度相比下降 45%。

At the end of the first quarter, our Lumivascular installed base was 147 accounts, a slight decrease from 152 at the end of Q4 2017 as the company continues to focus on supporting catheter utilization with our streamlined sales force in our most productive territories and accounts.

在第一季度末，我們的 Lumivascular 安裝基數為 147 個客戶，比 2017 年第四季度末的 152 個略有下降，因為公司繼續專注於通過我們最高效的地區和客戶中精簡的銷售人員來支持導管的使用。

Gross margin for the first quarter of 2018 was 22%, up from negative 17% in the comparable quarter of 2017.

2018 年第一季度的毛利率為 22%，高於 2017 年同期的負 17%。

The increase in gross margin for the quarter resulted from the increased efficiency associated with the company's more streamlined operational infrastructure and from a reduction in charges to inventory that negatively impacted gross margin in the first quarter of 2017.

本季度毛利率的增長是由於與公司更精簡的運營基礎設施相關的效率提高，以及庫存費用的減少，這對 2017 年第一季度的毛利率產生了負面影響。

Operating expenses for the first quarter of 2018 were $6.0 million compared to $13.2 million in the first quarter of 2017.

2018 年第一季度的運營費用為 600 萬美元，而 2017 年第一季度為 1320 萬美元。

This decrease was primarily attributable to reduced headcount expenses compared to the first quarter of 2017.

這一減少主要是由於與 2017 年第一季度相比員工費用減少。

Loss from operations for the first quarter of 2018 was $5.6 million compared to $13.8 million for the first quarter of 2017.

2018 年第一季度的運營虧損為 560 萬美元，而 2017 年第一季度為 1380 萬美元。

And net loss attributable to common stockholders for the first quarter of 2018 was $10.7 million compared to $15.3 million for the fourth quarter of 2017.

2018 年第一季度歸屬於普通股股東的淨虧損為 1070 萬美元，而 2017 年第四季度為 1530 萬美元。

Net loss per share attributable to common stockholders for the first quarter of 2018 was a loss of $5.37 compared to a loss of $25.74 for the first quarter of 2017.

2018 年第一季度歸屬於普通股股東的每股淨虧損為虧損 5.37 美元，而 2017 年第一季度為虧損 25.74 美元。

Adjusted EBITDA, which is a non-GAAP measure, was a loss of $4.7 million for the first quarter of 2018 compared to a loss of $11.9 million for the first quarter of 2017.

調整後的 EBITDA 是一項非 GAAP 指標，2018 年第一季度虧損 470 萬美元，而 2017 年第一季度虧損 1190 萬美元。

Cash and cash equivalents totaled $14.4 million as of March 31, 2018, compared to $5.4 million as of the end of December 31, 2017.

截至 2018 年 3 月 31 日，現金和現金等價物總計 1440 萬美元，而截至 2017 年 12 月 31 日則為 540 萬美元。

Currently, there are approximately 5.6 million shares of common stock outstanding.

目前，已發行的普通股約為 560 萬股。

There are also currently 41,800 shares of Series A preferred stock and approximately 8,600 shares of Series B preferred stock outstanding.

目前還有 41,800 股 A 系列優先股和大約 8,600 股 B 系列優先股已發行。

Each share of both series of preferred stock is convertible into 500 shares of the company's common stock at a conversion price of $2 per share.

這兩個系列的優先股每股可按每股 2 美元的轉換價轉換為 500 股公司普通股。

So assuming conversion of all preferred stock, we would have approximately 30.8 million shares of common stock outstanding.

因此，假設轉換所有優先股，我們將有大約 3080 萬股流通在外的普通股。

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

有了這個，我想把電話轉回傑夫。

Thanks, Matt.

謝謝，馬特。

We're pleased with the progress we've made this quarter and believe that 2018 will prove to be a pivotal time in the history of our company.

我們對本季度取得的進展感到滿意，並相信 2018 年將成為我們公司歷史上的關鍵時刻。

Avinger has completed a financial restructuring that provides vital support for the execution of our business plan.

Avinger 完成了財務重組，為我們的業務計劃的執行提供了重要支持。

We've taken important steps to drive efficiency and productivity throughout the organization with a strong focus on reducing cash usage throughout the year.

我們已採取重要措施來提高整個組織的效率和生產力，重點是減少全年的現金使用量。

And we've made good progress on the development of our product pipeline and in our various clinical initiatives with a number of important milestones still to come in 2018, including the anticipated approval and launch of our 2 next-generation Pantheris catheters, which we believe will fundamentally change our value proposition and position us for growth through the rest of this year and into 2019 and beyond.

我們在產品管線的開發和各種臨床計劃方面取得了良好進展，2018 年仍有許多重要的里程碑，包括預計批准和推出我們的 2 種下一代 Pantheris 導管，我們相信將從根本上改變我們的價值主張，並使我們在今年餘下時間和 2019 年及以後實現增長。

With that, we'll open to questions.

有了這個，我們將開放的問題。

(Operator Instructions) Our first question comes from the line of Jeffrey Cohen with Ladenburg Thalmann.

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

This is actually Destiny on for Jeff.

這實際上是傑夫的命運。

Okay.

好的。

So first, I was just wondering if you could provide a little reminder for us about the number of patients that are going to be enrolled in the INSIGHT trial as well as how many centers.

首先，我只是想知道您是否可以提醒我們將要參加 INSIGHT 試驗的患者人數以及有多少個中心。

Yes.

是的。

So the study will enroll up to 140 patients in 20 sites.

因此，該研究將在 20 個地點招募多達 140 名患者。

And since our last conference call, we continued to open new sites here in the U.S. and are in the process of opening 2 additional sites in Germany.

自上次電話會議以來，我們繼續在美國開設新網站，並正在德國開設另外 2 個網站。

So one of our strategy on this study is, of course, to continue to get a terrific ISR experience with our current device.

因此，我們在這項研究中的策略之一當然是繼續使用我們當前的設備獲得出色的 ISR 體驗。

But we're very excited to get the next-generation Pantheris into that study, both in Europe, where we already have CE Mark, and here in the U.S. following FDA approval.

但我們很高興能將下一代 Pantheris 納入該研究，無論是在我們已經擁有 CE 標誌的歐洲，還是在獲得 FDA 批准後的美國。

Okay, got it.

好，知道了。

And I think you said you now have 147 accounts.

我想你說過你現在有 147 個帳戶。

Is that correct?

那是對的嗎？

Yes, that's correct.

對，那是正確的。

147 accounts.

147 個帳戶。

So we've been right at around that 150 number for a couple of quarters here.

所以我們在這裡的幾個季度一直保持在 150 左右。

As I think we've discussed previously, our focus, while we're waiting for the FDA approval of the next generation with our smaller, kind of more focused sales force, is to support utilization on our existing accounts and really not to seek out driving growth other than kind of strategic, small initiatives along the way here prior to the approval of next-gen Pantheris.

正如我認為我們之前已經討論過的那樣，在我們等待 FDA 批准我們規模更小、更專注的銷售團隊的下一代產品時，我們的重點是支持對現有賬戶的利用，而不是真正尋求在下一代 Pantheris 獲得批准之前，在此過程中推動增長，而不是某種戰略性的小舉措。

But as we get closer to that, I anticipate, as we discussed, receiving that approval this quarter.

但隨著我們越來越接近這一點，我預計，正如我們所討論的那樣，本季度將獲得批准。

We're developing and kind of building our pipeline of new accounts that we can access as we go into the second half of the year.

我們正在開發並建立我們可以在進入下半年時訪問的新帳戶管道。

Okay, got it.

好，知道了。

And will there be any kind of like training delay for your sales force, where they'll have to take some time and learn about the new products?

對您的銷售人員來說，是否會有任何類似的培訓延遲，他們必須花一些時間來了解新產品？

Or are you kind of introducing them to the new products now so that they're prepared when it is approved?

還是您現在要向他們介紹新產品，以便他們在獲得批准時做好準備？

That's a great question.

這是一個很好的問題。

First of all, it is an evolution of an existing device.

首先，它是現有設備的演變。

So image interpretation and device setup is very similar.

所以圖像解釋和設備設置非常相似。

We also started as early as January at our sales meeting with our sales force.

我們也早在 1 月份就開始與我們的銷售人員舉行銷售會議。

As you may remember, number is around 18 -- or 18 folks now.

您可能還記得，人數大約是 18 人——或者說現在是 18 人。

We started training and actually put hands on the devices for our sales force starting in January and have continued that process to get them ready, especially in the initial sites that we'll launch into prior to launch of Pantheris.

從 1 月份開始，我們開始培訓並實際為我們的銷售人員提供設備，並繼續這個過程讓他們做好準備，特別是在我們將在 Pantheris 推出之前推出的初始站點。

But our sales team, overall, as you might remember as well, is a highly clinically experienced group, have been with us, most of them, for quite some time.

但總的來說，您可能還記得，我們的銷售團隊是一個臨床經驗豐富的團隊，他們中的大多數人已經和我們在一起很長一段時間了。

And even prior to joining us, had spent a lot of time in the cath lab or some of them even -- especially our clinical specialists, have come out of the cath lab.

甚至在加入我們之前，他們已經在導管室工作了很多時間，或者他們中的一些人——尤其是我們的臨床專家——已經離開了導管室。

So we think their learning curve, based on their current experience with Lumivascular, the training we've already done and their clinical competence, will be very rapid.

因此，我們認為，根據他們目前在 Lumivascular 方面的經驗、我們已經完成的培訓以及他們的臨床能力，他們的學習曲線將會非常迅速。

And they'll be prepared to start helping physicians, especially our current Lumivascular physicians, right away and to launch this important new device into new accounts as we move throughout the year.

他們將準備好立即開始幫助醫生，尤其是我們目前的 Lumivascular 醫生，並在我們全年移動時將這一重要的新設備推向新客戶。

Okay, that sounds great.

好的，聽起來不錯。

I guess my final question has to do with margins.

我想我的最後一個問題與邊距有關。

Is this kind of the level we should be expecting to see going forward?

這是我們應該期待看到的未來水平嗎？

Or do you expect additional efficiencies with things like operational infrastructure and like that?

或者您是否期望運營基礎設施等方面的效率更高？

Yes.

是的。

Thanks, Destiny.

謝謝，命運。

We were glad to see the significant increase that we did in the first quarter compared to the last few quarters, especially going through 2017.

我們很高興看到與過去幾個季度相比，我們在第一季度取得了顯著增長，尤其是在 2017 年。

But we do have a long way to go yet, and I expect we'll continue to see significant progress as we go through 2018.

但我們還有很長的路要走，我預計我們將在 2018 年繼續取得重大進展。

So it's a little bit hard to gauge exactly how quickly that will come.

因此，很難準確判斷這將以多快的速度到來。

A lot of it has to do with the volumes that we're producing.

這在很大程度上與我們生產的數量有關。

And that, of course, is driven a lot by our overall sales level.

當然，這在很大程度上取決於我們的整體銷售水平。

But we are expecting growth in revenue and production, and that will translate, we believe, to higher gross margins as well.

但我們預計收入和產量會增長，我們相信這也將轉化為更高的毛利率。

So we expect to see steady progress through this year and probably well into next year and afterwards.

因此，我們預計今年會看到穩步進展，可能會一直持續到明年及之後。

Thank you.

謝謝。

We have reached the end of our Q&A session.

我們的問答環節已經結束。

I'd like to hand the floor back over to management for closing remarks.

我想將發言權交還給管理層，讓他們發表閉幕詞。

Well, I'd like thank you all for calling in, for your continued interest in Avinger and the progress we're making.

好吧，我要感謝大家的來電，感謝你們對 Avinger 的持續關注以及我們正在取得的進展。

And we look forward to reporting on our continued progress when we communicate second quarter results.

我們期待在公佈第二季度業績時報告我們的持續進展。

Thank you very much.

非常感謝。

Thank you.

謝謝。

This concludes today's conference.

今天的會議到此結束。

You may disconnect your lines at this time, and thank you for your participation.

此時您可以斷開您的線路，感謝您的參與。