via NEWMEDIAWIRE -- Neovasc, Inc. ("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, 2020.
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 replacement
system
“Cardiovascular 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.”
Financial results for the second quarter
ended June 30, 2020
Revenues 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.
Conference Call and Webcast
informationNeovasc will be hosting a conference call and audio
webcast today at 4:30 pm ET to discuss these results.
Domestic: 1-888-204-4368International:
1-856-344-9299
Parties wishing to access the call via webcast
should use the link in the Investors section of the Neovasc website
at https://www.neovasc.com/investors/
About Neovasc Inc.Neovasc 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.
InvestorsMike
CavanaughWestwicke/ICR Phone:
+1.646.877.9641Mike.Cavanaugh@westwicke.com
MediaSean LeousWestwicke/ICR Phone:
+1.646.677.1839Sean.Leous@icrinc.com
Forward-Looking Statement DisclaimerCertain
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. 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.comor
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.
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