AtriCure,Inc.(ATRC) 首席执行官 Mike Carrel 于 2019年 第三季度业绩-收益电话抄本

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AtriCure Inc (NASDAQ:ATRC) Q3 2019 Earnings Conference Call October 30, 2019 4:30 PM ET

AtriCure Inc (NASDAQ:ATRC) Q3 2019 Earnings Conference Call October 30, 2019 4:30 PM ET

公司参与者

Lynn Lewis - Gilmartin Group
Mike Carrel - President and Chief Executive Officer
Andrew Wade - Senior Vice President and Chief Financial Officer

  • Lynn Lewis - Gilmartin Group
  • Mike Carrel - President and Chief Executive Officer
  • Andrew Wade - Senior Vice President and Chief Financial Officer

电话会议参与者

Robbie Marcus - JP Morgan
David Saxon - Needham
Danielle Antalffy - SVB Leerink
Adam Gunther - Piper Jaffray
Cecilia Furlong - Canaccord Genuity
Andrew Ranieri - Stifel Nicolaus

  • Robbie Marcus - JP Morgan
  • David Saxon - Needham
  • Danielle Antalffy - SVB Leerink
  • Adam Gunther - Piper Jaffray
  • Cecilia Furlong - Canaccord Genuity
  • Andrew Ranieri - Stifel Nicolaus

会议主持员

Good afternoon and welcome to AtriCure's Third Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes.
I would now like to turn the call over to Ms. Lynn Lewis from the Gilmartin Group for a few introductory comments.

Good afternoon and welcome to AtriCure's Third Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes.

I would now like to turn the call over to Ms. Lynn Lewis from the Gilmartin Group for a few introductory comments.

Lynn Lewis

Lynn Lewis

Thank you. By now you should have received a copy of the earnings press release. If you have not received the copy, please call 513-755-4136 to have one emailed to you. Before we begin today, let me remind you that the Company's remarks include forward-looking statements. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond AtriCure's control, including risks and uncertainties described from time-to-time in AtriCure's SEC filings. AtriCure's results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statements.
Additionally, we refer to non-GAAP financial measures, specifically revenue reported on a constant currency basis, adjusted EBITDA and adjusted loss per share. A reconciliation of these non-GAAP financial measures with the most directly comparable GAAP measures is included in our press release, which is available on our website.
With that, I'd like to turn the call over to Mike Carrel, President and Chief Executive Officer. Mike?

Thank you. By now you should have received a copy of the earnings press release. If you have not received the copy, please call 513-755-4136 to have one emailed to you. Before we begin today, let me remind you that the Company's remarks include forward-looking statements. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond AtriCure's control, including risks and uncertainties described from time-to-time in AtriCure's SEC filings. AtriCure's results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statements.

Additionally, we refer to non-GAAP financial measures, specifically revenue reported on a constant currency basis, adjusted EBITDA and adjusted loss per share. A reconciliation of these non-GAAP financial measures with the most directly comparable GAAP measures is included in our press release, which is available on our website.

With that, I'd like to turn the call over to Mike Carrel, President and Chief Executive Officer. Mike?

Mike Carrel

Mike Carrel

Thanks, Lynn. Good afternoon and thank you for joining us today. We are continuing our strong momentum from the first half of 2019 with total revenue in the third quarter of approximately $57 million, our 28th consecutive quarter of double-digit revenue growth. Our top-line performance was again driven by strength across our U.S. franchises.
With this strong momentum, we are raising our revenue outlook for 2019, which we now expect to be in the range of $227 million to $229 million. This range corresponds to growth of 13% to 14% for the year.
The third quarter was a very exciting quarter and transformative quarter for us here at AtriCure. It was highlighted by the strategic acquisition of SentreHEART, paving the way for our direct entry into the electrophysiology market.
As we discussed on our August call announcing the transaction, SentreHEART developed the LARIAT device, which is a percutaneous suture-based approach to close the left atrial appendage. This is particularly important given the groundswell of support and acceptance of managing the left atrial appendage in the treatment of Afib and the growth potential within the EP market.
The LARIAT device is currently being studied in the aMAZE clinical trial. The LARIAT product is on the market today in the U.S. under a 510(k) and in Europe. However, we expect very few devices to be sold outside of the aMAZE trial. Our top priority is to complete enrollment in this trial and we have made meaningful progress since the acquisition in August.
As of today, we have enrolled 579 patients and are on track to reach full enrollment of 600 patients in the first quarter of 2020. With the CONVERGE, DEEP AF and aMAZE trials, we have the only three clinical trials addressing the most complex and advanced forms of Afib.
Strategically, we expect the LARIAT technology to advance our position in the EP space, as is complementary to the endocardial catheter ablation procedures and multi-disciplinary approaches, such as CONVERGE and DEEP.
Each of these therapies offers a valuable treatment option for Afib patients and the total addressable market for the CONVERGE and DEEP and aMAZE procedures is well into the billions using conservative estimates.
Turning now to our quarterly results, we continue to execute and are seeing the benefit of our broad portfolio and robust pipeline. Specifically, in our U.S. business in the third quarter, we saw continued strength in our appendage management franchise, driven by our open and minimally invasive AtriClip products.
We again had meaningful contribution from our minimally invasive AtriClip PRO2 and PRO V devices, as well as from our open chest AtriClip Flex V device.
Within our open ablation platform, we remain focused on innovation, education, and training to address this large still under-penetrated market. We are progressing with our plan to launch a new open clamp in 2020, which we believe will be attractive to physicians who are seeking a simpler and faster approach to bleeding the heart in open procedures.

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谢谢,琳。下午好,感谢您今天加入我们。从2019年上半年开始,我们将继续保持强劲势头,第三季度总收入约为5700万美元,这是我们连续第28个季度实现两位数的收入增长。美国各专营店的实力再次推动了我们的顶级业绩。

凭借这种强劲的势头,我们正在提高2019年的收入前景,我们现在预计将在2.27亿美元至2.29亿美元之间。该范围对应于全年13%到14%的增长。

对于我们这里的AtriCure而言,第三季度是非常令人兴奋的季度,也是变革性的季度。战略性收购SentreHEART突显了这一点,为我们直接进入电生理市场铺平了道路。

正如我们在8月宣布该交易的电话会议上所讨论的那样,SentreHEART开发了LARIAT设备,该设备是一种基于经皮缝合的方法来闭合左心耳。考虑到在治疗Afib方面支持和接受处理左心耳的支持以及EP市场的增长潜力,这一点尤其重要。

LARIAT设备目前正在aMAZE临床试验中进行研究。 LARIAT产品今天以510(k)的价格在美国和欧洲上市。但是,我们希望在aMAZE试用版之外出售很少的设备。我们的首要任务是完成该试验的注册,并且自8月被收购以来我们已经取得了有意义的进步。

截止到今天,我们已经招募了579名患者,并有望在2020年第一季度全面招募600名患者。通过CONVERGE,DEEP AF和aMAZE试验,我们只有三项针对最复杂和最先进的临床试验Afib的形式。

从策略上讲,我们希望LARIAT技术能够提高我们在EP领域的地位,这是对心内膜导管消融手术和多学科方法(例如CONVERGE和DEEP)的补充。

这些疗法中的每一种都为Afib患者提供了有价值的治疗选择,并且使用保守估计,CONVERGE,DEEP和aMAZE程序的总潜在市场已达数十亿。

现在来看我们的季度业绩,我们继续执行并看到我们广泛的产品组合和强大的销售渠道所带来的好处。具体来说,在我们的第三季度美国业务中,我们的阑尾管理产品系列获得了持续增长的实力,这是由开放式和微创AtriClip产品推动的。

微创AtriClip PRO2和PRO V设备以及开胸式AtriClip Flex V设备再次为我们做出了有意义的贡献。

在我们的开放式消融平台内,我们将继续专注于创新,教育和培训,以解决这个仍未渗透的庞大市场。我们正在推进计划于2020年推出新的开放钳位的计划,我们认为这对寻求开放性手术中更简单,更快速地使心脏出血的医生具有吸引力。

While we anticipate broad market appeal, we expect to be particularly resonant with the Cabot surgeons in the open concomitant space and to be accretive to our open ablation revenue.
In addition, in the third quarter, we received FDA clearance for Expanded Labeling Claims for AtriClip's family devices. We were able to demonstrate the clinical evidence that AtriClip devices both exclude and electrically isolate the left atrial appendage. This expansion of the AtriClip labeling is important because epicardial exclusion of the appendage has multiple benefits.
Over the past several years, we have invested in our AtriClip portfolio with innovative new products and evidence to support increasing adoption. Physicians continue to recognize the benefits of the left atrial appendage management and how the AtriClip line of left atrial appendage management devices can serve their needs in a variety of different ways.
The cryoSPHERE probe, our dedicated device for managing post-operative pain in cardiothoracic surgical patients also contributed to our strong U.S. results in the third quarter. While, it's still early and overall revenue contribution is still relatively low, we are seeing this therapy perform well and our account base continues to build.
We are seeing – we are steadily bolstering our small, dedicated thoracic team with clinical resources to support cases in select markets. Our approach is focused on depth, rather than breadth as we first identify accounts that we believe in a comprehensive and innovative pain management program for their patients and then, we go deep adding resources support case volume as the business builds.
We are encouraged by our results and expect the thoracic pain management market to offer significant opportunity over the long-term.
Transitioning to our MIS ablation business, U.S. revenues were up 14% in the quarter, rebounding from year-to-date growth of approximately 1%. This is consistent with the quarterly fluctuations we have been experiencing in this franchise and the variability that we expect to continue until we receive FDA approval of our EPiSense system using the convergent approach in treating symptomatic persistent Afib patients.
As it relates to the CONVERGE trial, I want to take a step back and review our timeline and expectations again. The last patient in the study was treated in August 2018 and one-year follow-up was completed recently.
Our clinical team is working through the data and are on track to submit the final PMA module, including training protocols and other details by the end of this year. The convergent procedure is a novel therapy for patients group for whom there is no product group label for stand-alone treatment are persistent and long-standing persistent Afib. With that in mind, we are expecting the FDA to convene a panel.
We anticipate that we will release the data in 2020, along with our submission and preparation for the panel. Based on this timeline, we are optimistic that we could receive FDA approval toward the end of 2020, although this is clearly dependent on the process within the FDA.

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尽管我们预计将有广阔的市场吸引力,但我们希望在开放伴随的空间中与卡博特外科医师特别共鸣,并增加开放消融收入。

此外,在第三季度,我们因AtriClip家庭设备的扩展标签声明获得了FDA许可。我们能够证明AtriClip装置既排除并电隔离左心耳的临床证据。 AtriClip标记的这种扩展很重要,因为心外膜的心外膜排斥有很多好处。

在过去的几年中,我们通过创新的新产品和证据支持AtriClip产品组合,以支持日益普及的应用。医师继续认识到左心耳管理的好处,以及左心耳管理设备的AtriClip系列如何以各种不同方式满足其需求。

cryoSPHERE探头是我们用于管理心胸外科手术患者术后疼痛的专用设备,也为我们在第三季度取得了良好的美国业绩做出了贡献。虽然还很早,总收入贡献仍然相对较低,但我们看到这种疗法效果良好,并且我们的客户群不断建立。

我们看到了–我们正在稳步加强我们小的,专业的胸科团队,以其临床资源来支持特定市场中的病例。我们的方法侧重于深度,而不是广度,因为我们首先确定我们相信为其患者提供全面且创新的疼痛管理计划的客户,然后随着业务的发展,我们会深度增加资源支持案例的数量。

我们对我们的结果感到鼓舞,并期望胸痛管理市场能够长期提供重大机遇。

过渡到我们的MIS消融业务,本季度美国收入增长了14%,从年初至今的约1%的增长反弹。这与我们在该系列产品中经历的季度波动以及我们希望在获得美国食品药品监督管理局批准的采用收敛性方法治疗有症状的持续性房颤患者的EPiSense系统的波动性相一致。

与CONVERGE试用有关,我想退后一步,再次回顾我们的时间表和期望。该研究的最后一名患者于2018年8月接受治疗,并且最近完成了为期一年的随访。

我们的临床团队正在研究数据,并有望在今年年底之前提交最终的PMA模块,包括培训协议和其他详细信息。对于没有独立治疗的产品组标签的持久性和长期持久性Afib的患者组,收敛性治疗是一种新颖的治疗方法。考虑到这一点,我们希望FDA召集一个小组。

我们预计我们将在2020年发布数据,以及我们提交和准备小组的数据。基于这一时间表,我们很乐观地认为我们可以在2020年底获得FDA的批准,尽管这显然取决于FDA的程序。

Internationally, third quarter results were up modestly with strength driven by our open and appendage management businesses. We recently received CE Mark for our AtriClip Flex V and PRO V devices and look forward to their contribution in the European market in the future.
Broadly speaking, we continue to see steady growth prospects in the end-user markets in which we operate outside the US.
In summary, we are excited about our broadening portfolio and channels this quarter and are extremely pleased with our track record of sustained double-digit top line growth.
I will now turn the call over to Andy Wade, our Chief Financial Officer to review our financials and the outlook and we will return for closing comments.

Internationally, third quarter results were up modestly with strength driven by our open and appendage management businesses. We recently received CE Mark for our AtriClip Flex V and PRO V devices and look forward to their contribution in the European market in the future.

Broadly speaking, we continue to see steady growth prospects in the end-user markets in which we operate outside the US.

In summary, we are excited about our broadening portfolio and channels this quarter and are extremely pleased with our track record of sustained double-digit top line growth.

I will now turn the call over to Andy Wade, our Chief Financial Officer to review our financials and the outlook and we will return for closing comments.

Andrew Wade

Andrew Wade

Thanks, Mike. For the third quarter of 2019, worldwide revenue was $56.6 million, representing growth of 13.4% on a GAAP basis and 14% on a constant currency basis. Revenue from U.S. product sales was $46.1 million, an increase of 16% from the third quarter of 2018.
U.S. open ablation revenue increased 10.1% to $19.8 million. The addition of the cryoSPHERE probe in early 2019 is creating continued momentum in our open ablation franchise, along with steady contribution from open clamps.
U.S. sales of products used in minimally invasive procedures increased 14.3% to $9 million in the third quarter of 2019. The improvement from the prior year is due to comparison with a relatively soft third quarter minimally invasive sales in 2018.
As we have discussed on past calls, we anticipate quarterly volatility from this business. U.S. sales of appendage management products, which now includes the LARIAT system were $16.9 million during the third quarter of 2019, an increase of 25.4%, driven primarily by AtriClip products.
We again realized very strong growth from the AtriClip Flex V device, along with volume increases in the minimally invasive LAA exclusion system devices. We remain confident in sustaining growth rates for our appendage management products.
International revenue was $10.5 million, up 3.1% on a GAAP basis and 6% on a constant currency basis, as compared to the third quarter of 2018. Open ablation and appendage management products are driving our international business this quarter, offsetting a decline in revenue from minimally invasive ablation products.
Turning to specific markets, we continue to see growth throughout Asia and had solid performance in several key areas in Europe, notably, the UK, Turkey, and France with some weakness in Germany and The Netherlands.
Gross margin for the third quarter of 2019 was 73.8%, as compared with 72% for the third quarter of 2018. This improvement is due primarily to a decrease in share-based compensation from a one-time charge of approximately $500,000 in the third quarter of 2018, driven by the retirement of an operations leader.
In addition, mix was slanted to the U.S. business, which carries a higher gross margin. We continue to see improvements to operations and lower costs making strong progress toward our long-term goal of a consistent 75% gross margin.
In the third quarter of 2019, we had an adjusted EBITDA loss of $2.2 million, compared to a loss of approximately $500,000 for the third quarter of 2018. During the third quarter of 2019, we modified our definition of adjusted EBITDA to exclude acquisition costs due to their non-recurring nature.
Approximately, $3.6 million of acquisition costs were recorded for the SentreHEART acquisition in 2019. Our operating loss for the third quarter of 2019 was $8.6 million, compared to an operating loss of $6 million for the third quarter of 2018.
Our net loss per share was $0.25 for the third quarter of 2019, compared to a net loss per share of $0.22 for the third quarter of 2018. Note that the $3.1 million non-cash credit to operating expenses was recorded this quarter related to the change in contingent consideration liability.

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谢谢,迈克。 2019年第三季度,全球收入为5660万美元,按公认会计原则(GAAP)计算,增长13.4%,按固定汇率计算,增长14%。美国产品销售收入为4,610万美元,较2018年第三季度增长16%。

美国的开放式消融收入增长了10.1%,达到1,980万美元。在2019年初增加cryoSPHERE探针,在我们的开放式消融系列中创造了持续的动力,同时开放式钳位也做出了稳定的贡献。

2019年第三季度,美国用于微创手术的产品销售增长了14.3%,达到900万美元。与去年相比的增长是由于与2018年第三季度微创销售相对疲软相比。

正如我们在过去的电话会议上讨论的那样,我们预计该业务将出现季度波动。 2019年第三季度,包括LARIAT系统在内的美国附件管理产品在美国的销售额为1,690万美元,增长25.4%,主要是由AtriClip产品推动的。

我们再次意识到AtriClip Flex V设备的强劲增长,以及微创LAA排除系统设备的体积增加。我们对维持附件管理产品的增长率保持信心。

国际收入为1,050万美元,与2018年第三季度相比,按公认会计原则(GAAP)计算,增长3.1%,按固定汇率计算,增长6%。开放式消融和附件管理产品推动了本季度的国际业务,抵消了收入的下降来自微创消融产品。

转向特定市场,我们将继续在整个亚洲看到增长,并且在欧洲的几个关键领域表现出色,尤其是英国,土耳其和法国,而德国和荷兰则表现疲软。

2019年第三季度的毛利率为73.8%,而2018年第三季度的毛利率为72%。这主要是由于基于股票的薪酬从第三季度的一次性费用减少了约500,000美元运营领导者的退休推动了2018年的业务增长。

此外,混合业务也向美国业务倾斜,该业务的毛利率更高。我们继续看到运营改善和成本降低,朝着实现毛利率稳定在75%的长期目标迈出了坚实的一步。

在2019年第三季度,我们的调整后EBITDA亏损为220万美元,而2018年第三季度为亏损约500,000美元。在2019年第三季度,我们修改了调整后EBITDA的定义,以排除应付的收购成本使其具有非重复性

2019年,SentreHEART的收购记录了约360万美元的收购成本。我们2019年第三季度的经营亏损为860万美元,而2018年第三季度的经营亏损为600万美元。

2019年第三季度的每股净亏损为0.25美元,而2018年第三季度的每股净亏损为0.22美元。请注意,本季度记录了310万美元的非现金营业费用贷方,与变动有关或有对价负债。

Without this non-cash credit to operating expenses, our adjusted loss per share for the third quarter of 2019 was $0.33 and our operating loss would have been $11.7 million.
Similarly, a $780,000 non-cash credit to operating expenses was recorded in the third quarter of 2018 for the change in contingent consideration liability. Adjusted loss per share for the third quarter of 2018 was $0.24 and our operating loss would have been $6.8 million. Adjusted EBITDA results for all periods exclude non-cash adjustments related to the contingent consideration liability.
Excluding the impact of the non-cash adjustments to the contingent consideration liability, operating expenses increased approximately $10.7 million from $42.8 million in the third quarter of 2018 to $53.5 million in the third quarter of 2019.
Research and development expenses, which include clinical and regulatory activities were $10.2 million for the third quarter of 2018 or 18% of sales. Increases in personnel costs, clinical and consulting expenses and amortization contributed to the $1.6 million total increase in research and development expenses.
SG&A expenses, excluding the non-cash adjustments previously described, increased approximately $9.1 million from the third quarter of 2018 to a total of $43.3 million or 77% of sales. The increased results from the SentreHEART acquisition cost and higher personnel cost from our continued investment in the commercial organization worldwide, as well as incremental trade show and training activities and increases in share-based compensation expense and other operating costs.
We ended the quarter with approximately $100 million in cash, cash equivalents and investments, down approximately $3.6 million from the second quarter.
Lastly, we are updating our guidance for 2019. We now anticipate top-line revenue growth of approximately 13% to 14% year-over-year or approximately $227 million to $229 million on a GAAP basis. We continue to anticipate gross margin will be approximately 73% to 74% for the year. The absorption of SentreHEART operating cost put some pressure on gross margin.
However, we believe this is a small tailwind against the improvements to gross margin that we have made throughout 2019. As a result, we are maintaining our guidance range for 2019. As we have stated many times, we are still marching toward our goal of 75% gross margins and continue to make progress on this front. We expect R&D expenses to be 18% to 20% of sales for the year.
Investments in this area include the aMAZE, ICE-AFIB, and DEEP AF IDE trials, growing clinical science activity and R&D pipeline development.
We expect SG&A expenses to be approximately 69% to 72% of sales in 2019, which includes non-cash adjustments to the contingent consideration liability recorded this year. The increase in SG&A expense is driven by thoughtful expansion of our worldwide sales team, investments in training and education, absorption of SentreHEART operating costs, along with heavier legal and acquisition costs.

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如果没有这种非现金贷记到运营支出中,我们2019年第三季度的调整后每股亏损为0.33美元,我们的运营亏损将为1170万美元。

同样,由于或有对价负债的变化,2018年第三季度记录了780,000美元的非现金营业费用贷项。 2018年第三季度的调整后每股亏损为0.24美元,而我们的运营亏损将为680万美元。所有期间的调整后EBITDA结果均不包括与或有对价负债相关的非现金调整。

扣除或有对价负债的非现金调整的影响,营业费用从2018年第三季度的4,280万美元增加至2019年第三季度的5,350万美元,约1,070万美元。

2018年第三季度的研发费用(包括临床和监管活动)为1,020万美元,占销售额的18%。人员费用,临床和咨询费用以及摊销费用的增加导致研发费用增加了160万美元。

SG&A支出(不包括先前所述的非现金调整)与2018年第三季度相比增加了约910万美元,至4,330万美元,占销售额的77%。 SentreHEART的购置成本增加了结果,而我们对全球商业组织的持续投资以及增加的贸易展览和培训活动,以及基于股份的补偿费用和其他运营成本的增加,导致了更高的人员成本。

截至本季度末,我们拥有约1亿美元的现金,现金等价物和投资,比第二季度减少了约360万美元。

最后,我们正在更新我们的2019年指导。我们现在预计收入的收入将同比增长约13%至14%,或按公认会计原则计算约为2.27亿美元至2.29亿美元。我们继续预计该年度的毛利率将约为73%至74%。 SentreHEART运营成本的吸收给毛利率带来了一定压力。

但是,我们认为这与我们在整个2019年实现的毛利率改善没有太大关系。因此,我们将维持2019年的指导范围。正如我们多次指出的那样,我们仍在朝着实现毛利率达到75%,并继续在这方面取得进展。我们预计研发费用将占全年销售额的18%至20%。

该领域的投资包括aMAZE,ICE-AFIB和DEEP AF IDE试验,不断增长的临床科学活动和研发管道开发。

我们预计2019年SG&A支出将占销售额的69%至72%,其中包括今年记录的或有对价负债的非现金调整。销售,管理与一般费用的增长是由于我们全球销售团队的周密扩张,对培训和教育的投资,SentreHEART运营成本的吸收以及较重的法律和收购成本所致。

We continue to expect an adjusted EBITDA loss for the full year 2019 to be in the range of $7 million to $9 million after absorbing the operating cost of SentreHEART since the acquisition. This adjusted EBITDA range for 2019 translates to an adjusted loss per share of between $1.07 and $1.14.
At this point, I would like to turn the call back to Mike for closing comments.

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在继续吸收自收购以来的SentreHEART的运营成本后,我们继续预计2019年全年的调整后EBITDA亏损将在700万至900万美元之间。 2019年的调整后EBITDA范围转换为每股调整后亏损在1.07美元至1.14美元之间。

在这一点上,我想回电给麦克,以结束评论。

Mike Carrel

Mike Carrel

Thank you, Andy. Before we open it for questions, I want to take a moment to acknowledge that September marks National Afib Awareness month. This is a critically important time in which we work to raise awareness for this life-threatening arrhythmia by helping the public become more familiar with the symptoms, warning signs and available treatment options.
More than 33 million people are affected by Afib worldwide and the majority of those are not addressed by standard of care. Through our social media channels, we showcased our Why Treat campaign and provided educational information about Afib and AtriCure's role in uniting patients with physicians.
In closing, our continued performance reflects our commitment to clinically differentiated products, the diversity of our business and the overall strength of our organization. We believe that the addition of SentreHEART will serve to accelerate our strategy and will allow us to treat more patients with Afib, thus expanding our total addressable markets in a meaningful way.
We are looking forward to a bright future shaped by growth prospects created by our many business catalysts such as, CONVERGE, aMAZE, Cryo Nerve Blocks and several more over the next several years.
We will now open it up to questions.

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谢谢你,安迪在我们提出疑问之前,我想花一点时间来承认9月是全国非fib意识月。这是至关重要的时刻,我们将通过帮助公众更加熟悉症状,警告信号和可用的治疗方法来提高对这一危及生命的心律失常的认识。

全世界有超过3,300万人受到Afib的影响,其中大多数人没有得到标准的护理。通过我们的社交媒体渠道,我们展示了我们的“为什么治疗”运动,并提供了有关Afib和AtriCure在使患者与医生团结中的作用的教育信息。

最后,我们的持续表现反映了我们对临床差异化产品的承诺,我们业务的多样性以及我们组织的整体实力。我们相信,SentreHEART的加入将有助于加快我们的战略,并使我们能够治疗更多的Afib患者,从而以有意义的方式扩展我们的整个潜在市场。

我们期待着由我们的许多业务催化剂(例如CONVERGE,aMAZE,Cryo Nerve Blocks等)创造的增长前景所塑造的光明未来,在未来几年中。

现在,我们将向大家提出问题。

问答环节

[Operator Instructions] Your first question comes from the line of Robbie Marcus from JP Morgan. Your line is open.

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[操作员说明]您的第一个问题来自JP Morgan的Robbie Marcus。 您的线路是开放的。

罗比马库斯

Thanks, guys and congrats on a really nice quarter.

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谢谢大家,恭喜您的季度真不错。

Mike Carrel

Mike Carrel

Thank you.

谢谢。

Andrew Wade

Andrew Wade

Thanks, Robbie.

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谢谢,罗比。

罗比马库斯

I was hoping you could start out with sort of the early feedback after the LARIAT acquisition or SentreHEART acquisition, what’s been the discussion? Are you starting to see moving in with the EPs? Is that relationship starting to build ahead of CONVERGE next year? Any feedback you could give early on would be great.

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我希望您可以从LARIAT收购或SentreHEART收购之后的早期反馈开始,讨论的是什么? 您开始看到进入EP了吗? 这种关系会在明年CONVERGE之前开始建立吗? 您可以尽早提供任何反馈都是很棒的。

Mike Carrel

Mike Carrel

Yes, I mean, it's obviously early, but the integration has gone really smoothly on many different fronts. I mean, first, more and more excited about the strategic nature of it. We've built great relationships with EPs on our side, but also they are introducing us into new EPs that we didn't have. They are doing a great job with their trial. We were a little bit nervous when we bought them with the enrolment slowdown.
And instead it's actually accelerated and actually increased and done very well in that front. I personally made visits to pretty much all of the KOLs that they were working very closely with and got very positive reception. Again, they are very excited about the aMAZE trial. The focus is on that trial. They want to make sure we are committed to it clinically and then bringing that product to market through obviously great education and training that will kind of bolster the team with.
I've also been really impressed with the team at SentreHEART. Just topnotch professionals across the board, both in the field team that is supporting the cases, to the clinical team, to the back office, they are just wonderful people with a great culture focused on the patient. They fit really well. I mean, you go through these, and you are not 100% sure, because you don't meet everybody when you are going through an acquisition.
And the people there have just been fantastic and fit in really well and blended and great conversations are going on already in the field. I'll say that, but at the same time, we are very focused on the aMAZE trial. We are making sure that our teams are focused on that that we're not diluting their attention from that and getting it kind of integrated out in the field quite yet.
It's more of an introductions and beginning to kind of create awareness, but we really want to make sure we get that trial done. We get it enrolled and we really kind of hit the ground running next year, as well. So, it's going great. I couldn't be happier with the acquisition and more excited today than I was two months ago.

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是的,我的意思是,这显然还为时过早,但是集成在许多方面都非常顺利。我的意思是,首先,它的战略性质越来越令人兴奋。我们已经与我们的EP建立了良好的关系,但是他们也将我们介绍给了我们所没有的新EP。他们的审判工作做得很好。当我们因入学速度放缓而购买它们时,我们有点紧张。

相反,它实际上是加速的,实际上是增加的,在那方面做得很好。我亲自访问了几乎所有与他们紧密合作的KOL,并获得了非常积极的接待。同样,他们对aMAZE试用感到非常兴奋。重点是该审判。他们希望确保我们致力于它在临床上,然后把该产品推向市场,通过明显良好的教育和培训,将一种加强团队配合。

SentreHEART团队给我留下了深刻的印象。全线只是拔尖人才,无论是在场上队员正支撑的情况下,临床团队,到后台,他们只是美好的人与一个伟大的文化重点病人。他们真的很合适。我的意思是,您经历了这些,但您不是100%确信,因为您在进行收购时不会遇到所有人。

那里的人们真是太棒了,他们真的很融洽,融洽相处,现场的对话也已经开始了。我会这么说,但与此同时,我们非常关注aMAZE试用。我们确保我们的团队集中在,我们不是从稀释他们的注意力,得到它在该领域一种集成了相当尚未。

它更多是作为介绍,并开始建立人们的知名度,但我们确实希望确保完成该试验。我们招募了我们,明年我们也确实会投入运营。所以,一切都很好。今天,我比两个月前更加高兴,并为这次收购感到更加兴奋。

罗比马库斯

Great, and then a follow-up here. The two line items that stood out to me this quarter were open heart ablation and AtriClip. I know this is not a new topic with outperformance in both of those segments. But I was just hoping you could give a little color, particularly in the third quarter, what you are seeing, where the growth is coming from. Is there any change in fundamentals or improvements that you see that would be helpful? Thanks a lot.

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太好了,然后在这里进行跟进。 本季度在我眼中脱颖而出的两个项目是心脏直视消融和AtriClip。 我知道这不是在这两个领域都表现出色的新话题。 但是我只是希望您能给一些色彩,特别是在第三季度,您所看到的,增长的来源。 您认为对基础或改进有任何帮助吗? 非常感谢。

Andrew Wade

Andrew Wade

I wouldn't say that there is any change, per se. On the open side of our business it comes down to two different pieces. We can, as I mentioned, near here at the end. We are really pushing hard on this Afib awareness and the treatment concomitantly. As you probably well know, we've invested heavily to improve the penetration in the open space over the last seven to eight years since we got ourselves the PMA in that space and we've more than doubled the number of patients every year around the globe.
In the U.S. in particular, they are actually getting treated. That being said, it's still only 25% of the patients that are on the table are getting treated. Dr. McCarthy just came out with a paper on that where he actually analyzed all the CMS data, looked at it and demonstrated that there are still 75% of the patients that have Afib that are getting operated on or not getting treated.
And so we've got a big under-penetrated market in front of us with that and I think you see some of that that we will continue to have that with our training and education and the programs that we are running.
On top of that, I would – the other part of the open side of our business is that we did get benefit in cryoSPHERE and the Cryo Nerve Block team, as well. So we get a couple of points from that, because that team is doing very well. It is small numbers, but it can impact that growth a little bit as well and kind of give us some good kind of behind the scenes numbers from there. We are giving specifics.
On the AtriClip franchise, it actually plays off of that open business quite extensively, because a lot of the clips or the Flex V clips that are going in into those open cases. People just love that product. It's been on the market now for about a year and people are using it. It's easy, simple. It doesn't cause them any kind of a cheat when they actually place the clip.
It's a smaller profile. So, I'd say that that innovation is continuing to kind of build steam and momentum in that open business in particular. And then, on the other side of our business, on the MIS side, the strength in MIS, kind of helps off on that, because it's concomitant typically with that.

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我不会说任何改变本身。在我们业务的开放方面,它分为两个不同的部分。正如我提到的那样,我们可以在这里尽头。我们真的在努力提高对Afib的认识并同时进行治疗。如您所知,自从我们将PMA放入该空间以来,在过去的七到八年里,我们已经投入大量资金来改善开放空间的渗透率,并且每年,在该区域中,患者的数量增加了一倍以上地球。

特别是在美国,他们实际上正在接受治疗。话虽如此,桌上只有25%的患者正在接受治疗。 McCarthy博士刚刚发表了一篇论文,他在其中实际分析了所有CMS数据,进行了观察,并证明仍有75%的Afib患者正在接受手术或未接受治疗。

因此,我们面临着一个渗透率低的大市场,我想您会发现,随着我们的培训和教育以及我们正在运行的程序,我们将继续拥有其中的一些市场。

最重要的是,我想-业务开放的另一部分是,我们确实从cryoSPHERE和Cryo Nerve Block团队中受益。因此,我们从中得到了几点,因为该团队的表现非常出色。这个数字很小,但也会对增长产生一点影响,这给我们提供了一些很好的幕后数字。我们提供细节。

实际上,在AtriClip系列产品中,它实际上是在大量开展开放业务的过程中发挥作用的,因为大量的剪辑或Flex V剪辑都加入了这些开放案例。人们只是喜欢这种产品。它已经投放市场约一年了,人们正在使用它。简单,简单。当他们实际放置剪辑时,它不会引起他们任何形式的欺骗。

这是一个较小的配置文件。因此,我想说的是,创新尤其在那种开放的业务中不断产生动力和动力。然后,在我们业务的另一端,在MIS方面,MIS的优势在某种程度上有所帮助,因为它通常与此同时发生。

会议主持员

Your next question comes from the line of David Saxon from Needham. Your line is open.

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您的下一个问题来自Needham的David Saxon。 您的线路是开放的。

David Saxon

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大卫·撒克逊

Thanks, Mike and Andy. I guess, just a quick one. Can you let us know how much SentreHEART was in the quarter?

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谢谢,迈克和安迪。 我想,只是一个快速的。 您能告诉我们本季度SentreHEART多少钱吗?

Andrew Wade

Andrew Wade

Very – it was almost nothing. I mean, it was a very, very, very small number within this quarter. We got - bought them on August 13th. Obviously, the focus was – we were really focused on the trial. So, it's very little bit of revenue in this quarter.

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非常-几乎没有。 我的意思是,这个季度的数量非常少。 我们在8月13日购买了它们。 显然,重点是–我们确实专注于审判。 因此,本季度的收入很少。

David Saxon

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大卫·撒克逊

Okay, great. And then, just looking at the box clamp, can you talk about kind of how it's going to be priced and maybe your thoughts on the pace of adoption once you launch it?

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好,太棒了。 然后,仅看一下盒子夹,您能否谈一谈它的定价方式,以及您在推出产品时对采用速度的看法?

Mike Carrel

Mike Carrel

Yes, I think you are talking about the new clamp that we were looking at for kind of the open part of our business and we are looking to kind of have that sometime next year. The pricing will be above what we are charging for the price of our product today likely. We haven't set on a specific price at this time. But we do anticipate that it will be far north of what you get with a regular clamp today.
It's more sophisticated and it's actually obviously attacking the heart and making a lot simpler and easier for these physicians to get better and broader ablations.

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是的,我想您是在谈论我们正在寻找的新的钳位,这是我们业务的一部分,我们希望在明年的某个时候拥有该钳位。 定价可能会高于我们今天对产品价格收取的价格。 目前我们尚未设定具体价格。 但是,我们确实希望它会远远超出您今天常规固定的目标。

它更加复杂,实际上显然在攻击心脏,使这些医生更容易获得更好,更广泛的消融。

David Saxon

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大卫·撒克逊

Great. And just lastly, how are you progressing with higher-end clinical support in advance of CONVERGE?

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大。 最后,您在CONVERGE之前如何获得高端临床支持?

Mike Carrel

Mike Carrel

Great question. We've been actually building out that team for the last several years. And so it's – we've got a wonderful clinical team that is trained both on the clinical side, but also on our minimally invasive team to kind of get them up to speed, understand that product line.
So, we are progressing very, very well. We've got, I believe about 15 or 16 minimally invasive managers that are out there today and we've got about five or so on the clinical side. We anticipate that, we will continue to extend and add more to that team and we found just wonderful people in those roles. They've been a great fit and they get up to speed very quickly.

好问题。 在过去的几年中,我们实际上一直在组建该团队。 因此,我们拥有一支出色的临床团队,该团队不仅在临床方面接受培训,而且在我们的微创团队中接受过培训,以使他们快速掌握,了解该产品线。

因此,我们的进展非常非常顺利。 我相信今天有大约15或16位微创管理人员在临床上使用,而我们在临床方面大约有5个左右。 我们期望,我们将继续扩展并为该团队增加更多人,而我们在这些职位中只发现了出色的人才。 他们非常适合,他们很快就可以起步。

David Saxon

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大卫·撒克逊

Great, thanks and congrats on the quarter.

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太好了,谢谢您并祝贺这一季度。

Mike Carrel

Mike Carrel

Thanks.

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谢谢。

Andrew Wade

Andrew Wade

Thanks, David.

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谢谢大卫。

会议主持员

Your next question comes from the line of Danielle Antalffy from SVB Leerink. Your line is open.

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您的下一个问题来自SVB Leerink的Danielle Antalffy。 您的线路是开放的。

Danielle Antalffy

Hey, good afternoon guys. Thanks so much for taking my question. Congrats on another really solid quarter.

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嗨,大家下午好。 非常感谢您提出我的问题。 祝贺又一个非常稳定的季度。

Mike Carrel

Mike Carrel

Okay.

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好的。

Andrew Wade

Andrew Wade

Thanks, Danielle.

谢谢,丹妮尔。

Danielle Antalffy

Yes, no problem. Mike, I just wanted to follow-up on Robbie's question, and specifically as it relates to the open ablation outperformance. I know you guys have talked about that business as a high single-digit grower. Clearly, the last few quarters, you've been tracking ahead of that. I mean, does your view kind of change on what the durable growth profile is for this business?
It feels like maybe it's closer to low-double digits. But just curious on your view that based on the recent outperformance, one and also two, this quarter, as it was a strong TAVR quarter. So, curious if you can comment on what you are seeing or not seeing as it relates to the aortic side of the business.

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是没有问题。迈克,我只是想跟进罗比的问题,尤其因为它涉及到开放消融突出表现。 我知道你们已经谈论过作为一个高个位数种植者的生意。显然,过去几个季度,你已经跟踪要领先。 我的意思是,您对这项业务的持久增长状况有何看法?

感觉好像更接近低两位数。 但是,您只是好奇,鉴于最近这个季度的表现好于一个和两个,这是TAVR强劲的一个季度。 因此,很好奇您是否可以评论与业务主动脉方面有关的内容。

Mike Carrel

Mike Carrel

Yes. So, I mean, all really good questions. I'd say that, we are excited about what's happening in the open business. We continue to feel like, there is going to be strength there for a long time. I don't want to get ahead of ourselves to the numbers that you are talking about consistently on that basis.
That being said, we also have the Cryo Nerve Block that is a big upside opportunity for us really as we enter into 2020 and 2021, as those – that team becomes more mature, we get more coverage around the country. That definitely will help bolster -- and help out there quite a bit.
And we do feel like there's a huge opportunity open, but I don't know that I would get too far ahead of myself at this point relative to those growth rates on that front. And then do you asked another question? So, remind me the question I apologize.

是。 所以,我的意思是,所有非常好的问题。 我要说的是,我们对开放业务中发生的事情感到兴奋。 我们继续觉得,在那里会有很长一段时间的实力。 我不想超越您在此基础上一直在谈论的数字。

话虽如此,我们还有Cryo Nerve Block,对于我们来说,这确实是一个巨大的上升机会,因为我们进入2020年和2021年,随着这些团队的成熟,我们将在全国范围内获得更多覆盖。 这肯定会有所帮助-并在很大程度上有所帮助。

而且我们确实感觉到存在巨大的机会,但是相对于该方面的增长率,我不知道在这一点上我会超越自己。 然后你问另一个问题吗? 所以,提醒我我道歉的问题。

Danielle Antalffy

The impact of TAVR low risk on the aortic valve business. It seems like there is not much if we're - based on the numbers you put out, but curious what you are thinking.

TAVR低风险对主动脉瓣业务的影响。 根据您提出的数字,似乎我们所占的比例没有多少,但您对我们的想法感到好奇。

Mike Carrel

Mike Carrel

I think it's consistent with what we've talked about before, which is obviously it's having an impact on overall aortic volumes per se. But the penetration continues to be low and patients that have a Afib or diagnosed with Afib in advance, many of those patients are not getting treated with the TAVR. They're basically saying, what we know these patients do better.
There are our papers that are out there showing that if you actually - if those patients have Afib they do, do better if you treat them surgically with the Afib and just going in and doing the TAVR. So I think there is more data that's out there. We are getting the benefit of that. And we are not necessarily seeing it in our part of the aortic business. But there is pressure on the aortic side.
You are probably going to net on, probably lot of the valve company sides as well, but in terms of the pressure for us because the penetration is so low and the benefits of treating that Afib at the same time where it's not really affecting us at this point.

我认为这与我们之前讨论的内容一致,这显然对总体主动脉容积有影响。但是渗透率仍然很低,并且患有Afib或事先被诊断出患有Afib的患者,其中许多患者并未接受TAVR的治疗。他们基本上是说,我们知道这些患者的病情会更好。

我们提供的文件显示,如果您确实如此-如果这些患者患有Afib,那么如果您使用Afib对其进行手术治疗并且只是去做TAVR,则效果会更好。因此,我认为还有更多数据。我们正在从中受益。而且我们不一定会在主动脉业务中看到它。但是主动脉方面有压力。

您可能也会对很多阀门公司产生兴趣,但是对我们而言,这是因为渗透率非常低,并且在不真正影响我们的情况下同时处理Afib的好处给我们带来了压力这点。

Danielle Antalffy

Got it. And then, quick follow-up question for Andy. Just on the adjusted EBITDA, I appreciate your guidance for this year. You did come in better than we had expected in the quarter and just wondering if you can comment on how you are tracking towards adjusted EBITDA positive or profitability. Thanks so much.

得到它了。 然后,安迪快速跟进。 就调整后的EBITDA而言,我感谢您今年的指导。 您的收入确实比我们在该季度的预期中要好,只是想知道您是否可以就如何跟踪调整后的EBITDA正数或利润发表评论。 非常感谢。

Andrew Wade

Andrew Wade

Sure. So, the guidance we gave at the time of the deal back in August was that, we will lose $7 million to $9 million on the EBITDA line. We still feel comfortable with that range of guidance. As we said a couple of months out, we are, as Mike said, we are doing well on the integration front.
But we have absorbed the cost of running the trial and the infrastructure in which to make that successful. So, just feel good about the $7 million to $9 million, which is why we reiterated the guidance. So, nothing else really on that front.

当然。 因此,我们在八月份进行交易时给出的指导是,我们将在EBITDA线上损失700万至900万美元。 我们仍然对这一指导范围感到满意。 正如我们所说的几个月,正如Mike所说,我们在集成方面做得很好。

但是,我们已经承担了运行该试验的成本以及使该试验成功的基础架构。 因此,只要对这700万到900万美元感到满意,这就是我们重申指导的原因。 因此,在这方面没有其他东西。

Danielle Antalffy

Okay, thank you.

好的谢谢。

会议主持员

Your next question comes from the line of Matt O' Brien from Piper Jaffray. Your line is open.

您的下一个问题来自Piper Jaffray的Matt O'Brien。 您的线路是开放的。

Adam Gunther

亚当·冈瑟

Hi, it's Adam on for Matt. Congrats on the quarter and thanks for taking the questions. My first question is on AtriClip growth, which was strong again against a tough comp. Just wondering, have you seen any impact or benefit from the labeling changes that came in late August and is this helping shape conversations that your reps are having in the field and then I had a follow-up.

嗨,这是亚当(Adam)扮演的马特(Matt)。 祝贺本季度,并感谢您提出问题。 我的第一个问题是AtriClip的增长,在艰难的竞争中再次表现强劲。 只是想知道,您是否从8月下旬的标签更改中看到了任何影响或好处,这是否有助于形成您的销售代表在现场进行的交谈,然后我进行了跟进。

Mike Carrel

Mike Carrel

Yes. So I am going to kind of reverse the answer to that. We are – it's definitely shaping a lot of conversations, because there is more and more activity, EPs and then talking about the benefits of doing electrical isolation. In fact, the LARIAT product that we just bought, that is exactly what is doing and how it's reducing the Afib and the aMAZE trials.
So it does in general conversation allows for that and that's really been rich intellectual good discussion that we've been able to have as a result of that. People are excited to have that conversation and look at what the data was that supported it. I don't know that it’s driving our revenue in the short-term, I mean, it really – if you know our business well, we are kind of that – with that player that we are here for the long haul.
We have conversations and eventually we do think that it will be kind of the combination of that with the 20 other things that we have done over the course of the last four or five years with new product introductions and other data that comes out is really kind of continuing to improve the adoption of the left atrial appendage product we have. But I wouldn't say this specifically drove anything in the last six weeks .

是。因此,我将有点相反的答案。我们正在-无疑正在形成大量对话,因为有越来越多的活动,EP,然后谈论进行电气隔离的好处。实际上,我们刚购买的LARIAT产品确实正在做以及如何减少Afib和aMAZE试验。

因此,总的来说,对话确实可以做到这一点,而这正是我们能够进行的丰富的智力讨论。人们很高兴进行对话并查看支持它的数据是什么。我不知道这会在短期内推动我们的收入增长,我的意思是,如果您对我们的业务非常了解,那我们确实是这样–与该公司合作,我们将长期存在。

我们进行了交谈,最终我们确实认为这将与过去四,五年中我们通过新产品介绍和其他数据所做的其他20件事相结合。继续改善我们所拥有的左心耳产品的采用率。但是我不会说这在过去的六周内特别推动了任何事情。

Adam Gunther

亚当·冈瑟

That's helpful, thanks. And then, just wanted to ask a quick question on the Q3 performance. Just hoping you could parse out the U.S. and OUS dynamics a little bit more. U.S. came in better than we were expecting, while OUS came in a little bit softer. So just, any additional color on those would be helpful? Thanks for taking the questions.

很有帮助,谢谢。 然后,只想问一个关于Q3性能的快速问题。 只是希望您可以解析更多美国和OUS动态。 美国的表现好于我们的预期,而OUS的表现则稍逊一些。 因此,只要在这些颜色上添加其他颜色会有所帮助? 感谢您提出问题。

Mike Carrel

Mike Carrel

Sure. You are right. We did have a really strong U.S. business in this quarter and we continue to see a lot of strength in the U.S. going forward. That market is one that we are incredibly strong. I have great coverage and we saw a little bit of weakness in parts of Europe. We had a little bit of currency exchange impacts that many people have.
But a little bit of it was also in Germany and The Netherlands, where we felt a little bit of pressure. While we are strong in many other countries around Europe, those two countries in particular were a little bit softer. There is nothing in particular. You can look at and say, this is what caused it. We were just a little bit softer in those countries. And so the percentage had an impact on us.
But nothing really specific. We think that that will come back over time and overall, the rest of international was actually very strong .

当然。 你是对的。 我们在本季度的确有非常强劲的美国业务,而且我们继续在美国看到很多强大的实力。 这个市场是我们非常强大的市场。 我的报道范围很广,我们在欧洲部分地区看到了一些弱点。 我们对许多人的货币汇率产生了一些影响。

但是在德国和荷兰也有一些压力,我们在这里感到有些压力。 尽管我们在欧洲其他许多国家都很强大,但尤其是这两个国家要软一些。 没有什么特别的。 您可以看一下,然后说,这是造成它的原因。 在那些国家,我们的处境略软一些。 因此百分比对我们有影响。

但是没有什么真正具体的。 我们认为,随着时间的流逝,总的来说,国际上其他国家的实力将非常强大。

Adam Gunther

亚当·冈瑟

That's helpful. Thanks.

有帮助 谢谢。

会议主持员

Your next question comes from the line of Jason Mills from Canaccord. Your line is open.

您的下一个问题来自Canaccord的Jason Mills。 您的线路是开放的。

Cecilia Furlong

塞西莉亚·弗隆

Hi, this is actually Cecilia on for Jason, and I just wanted to ask about your open business again, specifically, CABG penetration with the new clamp. How you see this going forward in 2020 and other drivers that you see that can help drive penetration higher?

嗨,这实际上是杰西(Jason)的塞西莉亚(Cecilia),我只是想再问一遍您的开放业务,特别是CABG在新夹具上的渗透。 您如何看待2020年这一趋势以及您认为可以帮助推动渗透率提高的其他驱动因素?

Mike Carrel

Mike Carrel

Yes, another really good question relative to the new innovations that are coming out with. I am really excited about the new innovation on the clamp that we just talked about, because if you actually kind of go back in our history, we really haven't had a new innovation on the open side of our business for eight plus years, even a little bit more since the PMA.
We got the PMA in 2011. The focus then was on training and education, teaching people to do the procedure correctly, working with different societies, helping get the guidelines kind of where they are, all that work has been done.
We've created a lot of awareness and we've moved the needle a lot. But a lot of this, we have to make the procedure even easier to use for a broader base and that's really what the reason that we are doing this, this new clamp. We think it's going to be really well received. It's easier and simpler to use. And so we are pretty excited about that. It will likely come out sometime next year.
I don't anticipate and look at it being a catalyst to open revenue in 2020. But it really should help us sustain the kinds of open growth into 2021 and beyond. It can have – it's really complementary to the work we've done and the training that we've done in the past relative to that.

是的,相对于即将出现的新创新,另一个非常好的问题。我对刚才谈到的钳制式创新感到非常兴奋,因为如果您确实回顾了我们的历史,那么我们八年来确实没有在业务开放方面进行过创新,自PMA以来甚至更多。

我们在2011年获得了PMA。那时的重点是培训和教育,教人们正确地执行操作程序,与不同的社会合作,帮助人们获得所在地区的指导方针,所有工作都已完成。

我们已经建立了很多意识,并且已经动了很多针。但是,在很多情况下,我们必须使程序更易于使用,以扩大基础,这正是我们执行此操作的原因,即这种新的钳制。我们认为它将非常受欢迎。它更容易使用。因此,我们对此感到非常兴奋。它可能会在明年某个时候发布。

我预计并不会成为2020年开放收入的催化剂。但它确实应该有助于我们维持2021年及以后的开放增长。它可以拥有–它确实是对我们已经完成的工作以及过去与之相关的培训的补充。

Cecilia Furlong

塞西莉亚·弗隆

Great, thank you. And I guess, if I could just ask about your cryoSPHERE business, as well. What you've seen recently in terms of just areas of strength in adoption, any sales team dynamics and how you see this business? How you see building this business going forward?

太好了谢谢。 而且,我想,是否也可以询问您的cryoSPHERE业务。 您最近在采用方面的优势,销售团队的动态以及您如何看待这项业务方面看到了什么? 您如何看待这项业务的发展?

Mike Carrel

Mike Carrel

Sure. I mean we have hired up to eight therapy reps and two clinicals in that team. So about 10 people and then, a leader or a manager that's running that group right now. They've just done a phenomenal job of combining and working with our existing sales force that understands the hospitals that are selling into. One of the things that have been most impressed was just how well they have partnered at the hospital level in the markets that we are in.
A lot of what we're seeing is in the lung resection. I'd say that’s the vast majority of the cases, but also that's because that's the vast majority of cases that thoracic surgeons are doing and so, we see a lot of those cases, some replacing and some others in select areas in some smaller markets. But overall, that's really where we are seeing the vast majority of the cases today.
We anticipate next year, adding considerably to that team, as we expand other and new geographies around the country adding a combination of both sales team members and also clinicals that can support the cases. So, we do believe in that space. We think that we can impact it and more and more data is coming out to support the therapy.

当然。我的意思是,我们在该团队中雇用了多达八名治疗代表和两名临床医生。因此,大约有10个人,然后是负责该小组的领导或经理。他们刚刚完成了一项出色的工作,即与我们现有的销售人员结合并一起工作,他们了解要销售的医院。最令人印象深刻的事情之一就是他们在我们所进入的市场中在医院一级的合作伙伴关系如何。

我们看到的很多东西都在肺切除术中。我想说这是绝大多数病例,也是因为这是胸外科医生正在做的绝大多数病例,因此,我们看到了很多这样的病例,在一些较小的市场的某些特定区域中,有一些是替代性的,还有一些是替代性的。 。但是总的来说,这就是今天我们看到的绝大多数案例。

我们预计明年将为该团队增加大量人手,因为我们将在全国范围内扩展其他地区和新地区,同时增加销售团队成员和能够为案件提供支持的临床医生的组合。因此,我们确实相信这一空间。我们认为我们可以对其产生影响,并且越来越多的数据正在出来以支持该疗法。

Cecilia Furlong

塞西莉亚·弗隆

Great. Thank you and congrats on a great quarter.

大。 谢谢,恭喜您。

Mike Carrel

Mike Carrel

Thanks.

谢谢。

会议主持员

Your next question comes from the line of Rick Wise from Stifel. Your line is open.

您的下一个问题来自Stifel的Rick Wise。 您的线路是开放的。

Andrew Ranieri

安德鲁·拉涅利

Hi, Mike and Andy, it's Drew on for Rick tonight. I just wanted to go back to CONVERGE for a second. But at the time of your final patient hitting one year follow-up, it looks like there is probably about 100 patients that might have two years of follow-up.
Just when it comes time to see the data at the panel and when you submit that will you just submit 12-months follow-up for the entire patient pool or will we also be able to see a longer-term durability data from the broader patient population? And, just how do you think that might factor into the FDA's approval and labeling decision and translate into your ultimate market opportunity?

嗨,迈克(Mike)和安迪(Andy),今晚要为里克(Rick)参加。 我只是想回到CONVERGE一秒钟。 但是,当您的最后一名患者接受一年的随访时,似乎有大约100位患者可能接受了两年的随访。

当需要在面板上查看数据时,以及您提交该数据时,您只需要对整个患者库进行12个月的随访,或者我们还能从更广泛的患者那里看到长期的耐久性数据 人口? 而且,您如何认为这可能会影响FDA的批准和标签决定并转化为您的最终市场机会?

Mike Carrel

Mike Carrel

Yeah, it's a great question. We will likely, all the data that we basically have access to, some of the durability data we might be presenting some of that at the, panel. So I think you're asking a really good question, Drew. On top of that, as I've said before, I mean, when we look at kind of all of these single center data that's out there, we are very confident and feel very good about kind of where we are as a business with this.
We've got over 10,000 procedures that are been out there. We know how durable it is long-term and we think that that's also going to play a big role. We know the safety profile is both low, not only in the trial but also incredibly low in the use in the market and we are going to use all that data that’s available to us as we move forward to get the approval next year.

是的,这是一个很好的问题。 我们可能会获得我们基本上可以访问的所有数据,或者我们可能会在面板上呈现的一些耐久性数据。 所以我想你问的是一个非常好的问题,德鲁。 最重要的是,正如我之前说过的,我的意思是,当我们查看其中存在的所有这些单个中心数据时,我们非常有信心,并且对我们作为一家企业的这种情况感到非常满意 。

我们已经有超过10,000个程序。 我们知道它的长期耐用性,我们认为这也将发挥重要作用。 我们知道,安全性不仅在试验中很低,而且在市场上使用时也非常低,我们将继续使用明年获得的所有可用数据。

Andrew Ranieri

安德鲁·拉涅利

Got it. And then, just hopping over to LARIAT, I think, I heard you right, saying that you're now at 579 patients enrolled. I know the aMAZE trial is a big focus for you. You are up close to 40 patients since I think you announced the SentreHEART deal. But why is first quarter 2020 the right target and not sooner?
Is there anything that you are seeing in terms of enrollment slowdown, or is it just kind of the holiday season that might kind of delay that a little bit into next year?

得到它了。 然后,我跳到LARIAT,我想,我没听错,说您现在有579名患者。 我知道aMAZE试用版是您的重点。 自从我认为您宣布了SentreHEART交易以来,您将近有40位患者。 但是,为什么到2020年第一季度才是正确的目标而不是更快?

关于入学速度下降,您是否看到了什么?或者只是假期,可能会推迟到明年?

Andrew Wade

Andrew Wade

You are asking a great question and we could absolutely close it out and get it done by the end of this year. We are on a great pace. I am only being a little bit cautious just because, we just acquired them, we are getting a sense for what the patents look like. But right now, patient flow looks fantastic. And it could be very early in 2020 or late this year.
The guidance we want to give to stick to is early part and actually in the first quarter, just as you know, what happens in the end of the year with holidays and things like that. And again it's the first time that we've owned this. And I am getting a sense for it.
And so, quite frankly, the difference between whether it gets done on December 31st or February 15th, really, it doesn't make it up a large difference to us on the long-term market and what we are going after here.
We are already doing the work on the back-end on getting doing PMA readiness work, getting on the modules behind. So we are doing all that work behind the scenes. So I am not – the difference in days doesn't really matter. Yes, you are right. We've had great enrollment and it's very possible we close it out by the end of the year.

您提出的问题很重要,我们绝对可以在今年年底之前完成并解决问题。我们的步伐很大。我只是有点谨慎,因为我们刚刚获得了它们,我们对专利的外观有了一定的了解。但是现在,病人的流量看起来很棒。可能是在2020年初或今年年底。

如您所知,我们要坚持的指导是早期,实际上是在第一季度,在年底假期和类似的情况下会发生什么。这又是我们第一次拥有它。我对此很有感觉。

因此,坦率地说,是在12月31日还是在2月15日完成交易之间的差异,实际上,对于长期市场而言,这并没有对我们构成太大的影响,而在这之后我们将要做什么。

我们已经在进行PMA准备工作,在后面的模块上进行后端工作。因此,我们正在幕后进行所有工作。所以我不是–天数的差异并不重要。是的,你是对的。我们的招生人数很多,很可能在今年年底之前将其关闭。

Andrew Ranieri

安德鲁·拉涅利

Great. And then, just one last one. If you wanted to provide an update on some of your other clinical trials like, I'd say Afib, CCF indeed and then, separately, on Frost data. I think you've mentioned before that you expected in 2020. Can you maybe put a little finer point on when you might expect that data either at a conference or a publication? Thank you.

大。 然后,倒数第一。 如果您想提供其他一些临床试验的最新信息,例如Afib,CCF,然后分别针对Frost数据。 我认为您之前提到的是2020年的预期。是否可以在会议或出版物上提出更详细的数据? 谢谢。

Mike Carrel

Mike Carrel

All good questions, so clinical trial data, as kind of walking to the clinical trials, you are right. We really wanted to focus this call on kind of explaining and reminding and bringing the process for CONVERGE and then also kind of talking a little bit about our new acquisition with aMAZE and kind of making sure everybody is up to speed on that.
But you are right, and as I said that's our open trial as a reminder to everybody, it's a 160 patient enrollment. We have enrolled over 20 patients to-date. It's actually ahead of what our plan and schedule was, we've got 11 sites up and running. We may add a couple more sites over the course of the next several months to the early part of next year. But our focus now is to get the sites that we have up and running and going feel really bullish about that trial.
It's created a lot of excitement, again another way to kind of gather more clinical evidence within that open space, which is a big part of our business as everybody knows. On top of that, we've got the – you mentioned Frost and the data coming off of Frost. We do have many submissions have been had with various different journals. So we do anticipate it in one of the major shows next year that it will be accepted as an abstract and as a paper and be presented at one of those shows.
It could be STS, depends on whether or not these are accepted or several others that kind of occur in the first half of the year. When it comes to CCF, that's our trial. That's kind of the DEEP trial over in Europe and we are at 147 patients. And so, we are near statistical significance on the overall trial in terms of the enrollment.
We will know more by the end of the year and our hope is that they will kind of conclude enrollment sometime in the early part of next year. And then, we’ll obviously have to wait for one-year follow-up and everything after that point in time. And then, I think, the – and then, DEEP is the other one obviously -- which is DEEP in the US, the DEEP AF trial. We’re at 62 patients enrolled in total.
We are back on track. We've got - we had - we've got about 12 sites or so enrolling now. We've got a pipeline of six or seven sites that we anticipate over the next six months. We will kind of get up and running into that trial and feeling very good about the excitement for that. And in the cases that have happened so far to-date. So, lots of good activity.
Thanks for asking the question within our other clinical pillars, as well.

所有好的问题,因此,作为进入临床试验的一部分,临床试验数据是正确的。我们真的很想把这次会议的重点放在解释和提醒上,并介绍CONVERGE的流程,然后再谈论一下我们通过aMAZE进行的新收购,并确保每个人都加快速度。

但是您是对的,正如我所说的,这是我们的公开试验,以提醒所有人,这是160名患者的入组。迄今为止,我们已经招募了20多名患者。它实际上是超前的东西我们的计划和时间表是,我们已经有了11个站点和运行。在接下来的几个月到明年年初的过程中,我们可能会添加更多站点。但是,我们现在的重点是让我们已经启动并运行的网站对该试验真正感到乐观。

它创造了很多兴奋,这也是在该开放空间中收集更多临床证据的另一种方式,这是我们每个人都知道的业务的重要组成部分。最重要的是,我们提到了-弗罗斯特(Frost)和来自弗罗斯特(Frost)的数据。我们确实收到了许多不同期刊的投稿。因此,我们确实希望在明年的一个主要展览中可以接受它作为摘要和论文,并在其中一个展览中展示。

可能是STS,具体取决于是否接受了这些服务,或者取决于上半年是否发生了其他几种情况。关于CCF,这是我们的尝试。这是在欧洲进行的DEEP试验,我们有147名患者。因此,就招募而言,我们在整个试验中具有接近的统计意义。

到今年年底,我们将了解更多信息,我们希望他们能够在明年年初的某个时候结束注册。然后,我们显然将不得不等待一年的后续行动,然后再等待该时间。然后,我认为,然后是DEEP显然是另一个-在美国是DEEP,即DEEP AF试验。我们总共招募了62名患者。

我们回到了正轨。我们已经得到了 - 我们必须 - 我们已经有了大约12点或现在这么招收。我们已经得到的,我们预计在未来六个月内六个,七个地点的管道。我们将挺身而出参加该审判,并为此感到兴奋。到目前为止,还没有发生过这种情况。因此,很多良好的活动。

也感谢您在我们其他临床支柱中提出问题。

Andrew Ranieri

安德鲁·拉涅利

Great. Thanks, Mike. Appreciate the color.

大。 谢谢,迈克。 欣赏颜色。

会议主持员

There are no further questions at this time, please continue.

目前没有其他问题,请继续。

Mike Carrel

Mike Carrel

Great. Well again, everyone, thank you for joining us today. We look forward to another strong quarter in the fourth quarter and finishing off 2019 as we continue our commitment for treating people with Afib around the globe.
Thank you and have a wonderful day.

大。 再次,所有人,感谢您今天加入我们。 我们期待着第四季度又一个强劲的季度,并在2019年结束,因为我们继续致力于治疗全球Afib患者。

谢谢,祝你有美好的一天。

会议主持员

Ladies and gentlemen, this concludes today’s conference. Thank you for your participation and have a wonderful day. You may all disconnect.

女士们,先生们,今天会议结束。 感谢您的参与,祝您有美好的一天。 你们可能都断开了连接。

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