Neovasc Inc. (NASDAQ:NVCN) Q3 2019 Earnings Conference Call - Final Transcript

Nov 07, 2019 • 04:30 pm ET

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Neovasc Inc. (NASDAQ:NVCN) Q3 2019 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Good day, and welcome to the Neovasc Incorporated Third Quarter 2019 Earnings Call. Today's call is being recorded.

At this time, I would like to turn the conference over to Mike Cavanaugh with Westwicke Partners. Please go ahead, sir.

Executive
Mike Cavanaugh

Thank you. Good afternoon and thank you all for joining us today. Earlier today, Neovasc Incorporated released financial results for the third quarter ended September 30, 2019. The release is currently available on the Company's website at www.neovasc.com. Fred Colen, President and Chief Executive Officer, and Chris Clark, Chief Financial Officer, will host this afternoon's call.

Before we get started, I would like to remind everyone that management will be making statements during the call that contain forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws, including regarding potential pathways to the US market for the Reducer, the Company's intention to submit a PMA to the FDA in respect of the Reducer, the expected timing of such submission, and the Company's beliefs regarding efficiency of existing clinical evidence to support the PMA, expectations regarding growing awareness of the Reducer in Europe, timing expectations with respect to reaching a system design freeze in respect of the transfemoral-transseptal or TF/TS Tiara, initiating an early small clinical feasibility study in humans and first human implant, the Company's goals and expectations with respect to its share price, market value and investor base and the company's efforts to regain compliance with the NASDAQ listing rules including future expectations and risk factors.

These risk factors and others relating to the Company are discussed in greater detail in the Risk Factors section of the Company's annual report on Form 20-F and in the Management Discussion and Analysis for the three and nine months ended September 30, 2019, copies of which may be obtained at www.sedar.com or www.sec.gov. 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 examination of historical operating trends, expectations regarding coverage decisions, pricing and enrollment matters and our future financial expectations and results are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements.

Accordingly, you should not place undue reliance on these statements. For a list on descriptions of the risks and uncertainties associated with our business, please see our filings with the Canadian securities regulators and the US Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, November 7th, 2019. Neovasc disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections, or other forward-looking statements whether because of new information, future events or otherwise.

I will now turn the call over to Fred Colen, President and CEO of Neovasc.

Executive
Fred Colen

Thanks, Mike, and good afternoon, everyone. Before I