VANCOUVER and MINNEAPOLIS – (NewMediaWire) – August 06, 2020 – Neovasc,
(“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader
in the development of minimally invasive transcatheter mitral valve replacement
technologies, and minimally invasive devices for the treatment of refractory
angina, today reported financial results for the second quarter ended June 30,
Second Quarter Highlights
- Following a
COVID-related slowdown, experienced a sharp rebound in Reducer implants in
June, meeting pre-COVID monthly Reducer target
- Confirmed FDA
Circulatory Systems Devices Panel Meeting Date of Oct 27, 2020
- Advanced CE
Mark approval application for transapical Tiara TA mitral valve under
Medical Device Directive
- Conducted further
successful animal implants of transfemoral Tiara TF mitral valve
diseases did not take a break during the quarter, and neither did Neovasc. We continue to pursue the promise of our novel
devices to help patients with limited options for treating debilitating angina,
and advancing at the forefront of mitral valve replacement technology,” said
Fred Colen, Chief Executive Officer. “We
continued to focus on the commercialization of the Reducer in the EU, and were
pleased to see a sharp rebound of Reducer implants in June following the
postponement of many elective surgical procedures. We believe this speaks directly to Reducer’s
efficacy in treating refractory angina, and the FDA has scheduled an October
panel review of our PMA for Reducer. We advanced
our CE mark application in the European Union for the Tiara TA device, and we
completed further implants of the next generation transfemoral/trans-septal
Tiara TF device in animals. Importantly, Neovasc successfully cured the Nasdaq minimum
market cap breach during the quarter. We again thank our shareholders for their
continued support, and believe that we are well-positioned for the future.”
results for the second quarter ended June 30, 2020
in the quarter decreased 35% to $284,047 for the three months ended June 30,
2020, compared to revenues of $439,920 for the same period in 2019 as the Company
adapted to the impact of COVID.
The cost of goods sold for the three months ended June 30, 2020 was $74,669
compared to $66,994 for the same period in 2019. The overall gross margin in
the quarter was 74%, compared to 85% gross margin for the same period in 2019,
primarily due to lower volumes in the quarter.
Total expenses for the three months ended June 30, 2020 were $8,867,748,
a year over year increase of 27% from $7,006,157 in the second quarter of 2019.
The operating losses and comprehensive losses for the three months ended
June 30, 2020 were $8,658,370 and
$12,234,456, respectively, or $0.81 basic and diluted loss per share, as
compared with $6,633,231 operating losses and $7,989,849 comprehensive loss, or
$1.17 basic and diluted loss per share, for the same period in 2019. The
increase of $2,025,139 in operating losses can be explained by the increase
in product development and clinical trial expenses as the Company continues to
incur development and clinical costs related to Tiara and regulatory costs
related to Tiara and Reducer and additional legal expenses to retire the 2017
Notes and issue new 2020 Notes on significantly better terms.
As of August 6, 2020, the Company had 17,613,355 Common Shares issued
and outstanding. Our fully diluted share capital as of the same date is 29,104,333.
Call and Webcast information
Neovasc will be hosting a
conference call and audio webcast today at 4:30 pm ET to discuss these results.
Parties wishing to access the call
via webcast should use the link in the Investors section of the Neovasc website
About Neovasc Inc.
is a specialty medical device company that develops, manufactures and markets
products for the rapidly growing cardiovascular marketplace. Its products
include Reducer, for the treatment of refractory angina, which is not currently
commercially available in the United States and has been commercially available
in Europe since 2015, and Tiara, for the transcatheter treatment of mitral
valve disease, which is currently under clinical investigation in the United
States, Canada, Israel and Europe. For more information, visit: www.neovasc.com.
Forward-Looking Statement Disclaimer
Certain statements in this
news release contain forward-looking statements within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995 and applicable Canadian
securities laws that may not be based on historical fact. When used herein, the words
“expect”, “anticipate”, “estimate”,
“may”, “will”, “should”, “intend,”
“believe”, and similar expressions, are intended to identify
Forward-looking statements may involve, but are not limited to, the
belief that the rebound of Reducer implants speaks directly to Reducer’s
efficacy in treating refractory angina, the belief that the Company is
well-positioned for the future and the
statement regarding the growing cardiovascular marketplace. Forward-looking
statements are based on estimates and assumptions made by the Company in light
of its experience and its perception of historical trends, current conditions
and expected future developments, as well as other factors that the Company
believes are appropriate in the circumstances.
Many factors could cause the Company’s actual results, performance or
achievements to differ materially from those expressed or implied by the
forward-looking statements, including those described in the “Risk
Factors” section of the Company’s Annual Report on Form 20-F and in the
Management’s Discussion and Analysis for the three and six months ended June
30, 2020 (copies of which may be obtained at www.sedar.com or www.sec.gov).
These factors should be considered carefully, and readers should not
place undue reliance on the Company’s forward-looking statements. The Company
has no intention and undertakes no obligation to update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.