NASDAQ, TSX: NVCN
- FDA has granted Breakthrough Device designation to the Neovasc
Reducer™ (the "Reducer") for the treatment of refractory
angina
- Reducer implanted in 100th patient in Germany
- Tiara™ (the "Tiara") featured in live case at the 32nd Annual
European Association for Cardio-Thoracic Surgery (EACTS) Meeting in
Milan
- Peer-reviewed article on Tiara cases published in Circulation:
Cardiovascular Interventions
- Regained compliance with the Nasdaq minimum bid price rule
VANCOUVER, Nov. 14, 2018 /PRNewswire/ - Neovasc, Inc.
("Neovasc" or the "Company") (NASDAQ: NVCN TSX: NVCN), a leader in
the development of minimally invasive transcatheter mitral valve
replacement technologies and in the development of minimally
invasive devices for the treatment of refractory angina, today
reported financial results for the third quarter ended September 30, 2018.
"In the first nine months of 2018, we successfully managed
several critical corporate events and achieved many significant
therapy development milestones for both of our product platforms.
As a result, the Company is now on a stronger foundation from which
to continue advancing our product development, clinical and
commercial programs for the Reducer and Tiara," said Fred Colen, President and Chief Executive
Officer of Neovasc. "While there are still challenges to overcome,
we have developed a clear value creation strategy for the Company's
patients, employees, and investors alike. This will be
achieved through our team's proven ability to deliver on the
well-defined critical future milestones we have established for our
two product platforms, the Tiara and the Reducer."
Mr. Colen continued, "The Tiara clinical outcome data, which we
have been regularly reporting on, is increasingly generating
positive attention as a leading option for minimally invasive
mitral valve replacement for patients suffering from severe mitral
regurgitation. This growing collection of robust clinical data also
includes the publication of a peer-reviewed article in the
Cardiovascular Interventions journal, a live case
demonstration at the 32nd Annual European Association
for Cardio-Thoracic Surgery meeting, and presentations of new
clinical data at several scientific conferences. We believe that
our ongoing efforts to build awareness of the Tiara and its
benefits for patients with severe mitral regurgitation in the
clinical community will help drive increased enrollment for our
TIARA-II study in Europe."
"Positive momentum for the therapy development and
commercialization activities of the Reducer in Europe continues to build, with sales in the
third quarter of 2018 increasing by 44% year-over-year and
increasing by 45% for the first nine months of 2018 over the same
period in 2017. The Company has launched a couple of pilot programs
in Germany for the required
Reducer therapy development with referring physicians together with
a professional therapy development organization, to quickly learn
more about these therapy development challenges and opportunities,"
concluded Mr. Colen.
The Tiara Mitral Valve
To date, 63 patients have been treated with Tiara in the TIARA‑I
early feasibility clinical study, in compassionate use cases and in
our European TIARA‑II CE Mark clinical study ("TIARA-II"). The
30‑day survival rate for the 63 patients treated with the Tiara
(i.e. those treated more than 30 days ago) is 53/59 or 90% with one
patient now over four years post implant and five patients over two
years post implant. The Tiara has been successfully implanted in
both functional and degenerative mitral regurgitation patients, as
well as in patients with pre‑existing prosthetic aortic valves and
mitral surgical annuloplasty rings.
To date, 22 patients have been treated under compassionate use,
21 patients in the TIARA-I clinical study and 20 patients in the
TIARA-II clinical study. The 30 day survival rate for patients who
reached the 30 day time point, is 90% overall and is 94% in the
TIARA II study. On October 20th, the
Tiara was featured in a "live case" at the 32nd Annual European
Association for Cardio-Thoracic Surgery Meeting in Milan. The successful procedure was performed
by Dr. Lenard Conradi and Dr.
Ulrich Schaefer of University
Medical Center Hamburg-Eppendorf in Hamburg, Germany and then broadcasted to a
large audience at the conference. In approximately 14 minutes, for
the delivery system/heart interaction, the doctors were able to
implant the Tiara device and completely resolve the patient's
severe mitral regurgitation, without any procedural
complications.
The November issue of Cardiovascular Interventions
included a peer-reviewed article reporting on cases of
transcatheter mitral valve replacement using the Tiara valve in
patients with previous aortic valve replacement. These patients
were considered extremely high-risk due to their severe mitral
regurgitation and previous surgical aortic valve prosthesis, but
the article describes great short-term outcomes. The surgery had a
success rate of 100% with no death or major complications and,
immediately following implantation, the patients' mitral
regurgitation was eliminated. This publication supports Tiara as a
technically feasible and safe option for these high-risk patients.
In addition, the editor of the Journal stated in editorial
comments, that: "The investigators, are taking the field of TMVR to
the next level where both prosthetic aortic valves and
transcatheter mitral prosthesis coexist, and should be
congratulated for their contribution."
Enrollment of patients in the European TIARA-II clinical study
continues. All factors influencing enrollment have been reviewed
and as a result the Company implemented an easy-to-use, local
pre-screening tool for physicians and clinical sites, increased the
number of fully qualified proctoring physicians, now with two fully
qualified European physicians as proctors available, and the
Company increased its field clinical engineering support in
Europe, most recently adding two
very experienced field clinical/market development personnel in
Germany.
Most importantly, the Company keeps working with its currently
qualified clinical sites and adding new clinical sites and we are
pleased to see much interest from new potential clinical sites.
Neovasc currently has 13 active and qualified TIARA-II
clinical study sites and five more in the
qualification/approval phase. Furthermore, the Company is currently
reviewing up to three additional clinical sites for the
qualification initiation process, in order to bring the total
amount of clinical sites in the TIARA-II study to 20 sites, which
is the maximum approved number of sites overall. As a result of all
of these actions, the Company believes it will be able to increase
enrollment in the TIARA-II clinical study.
Concept development activities for the transfemoral,
trans-septal Tiara version also continued with steady progress on
the Tiara valve modifications, enabling a smaller profile delivery
system and treatment of a larger patient population with severe
mitral valve regurgitation. Trans-septal delivery system design
concept trade-off engineering work also continued. Neovasc is
planning to finalize the trans-septal Tiara system design concept
during the first quarter of 2019.
The Reducer
The Company is encouraged by the ramping
of market interest in the Reducer. In May
2018, at the Euro PCR Conference in Paris, the Reducer was showcased during a
dedicated symposium hosted by Dr. Stefan
Verheye and Dr. Shmuel Banai.
The symposium included presentations from physicians on their
clinical experience with Reducer, discussions about potential
additional applications for Reducer, and a cost/benefit analysis of
Reducer utilizations for healthcare systems.
The commercial progress for the Reducer in Europe and the Middle East in the first nine months of 2018
was encouraging with a 45% increase in revenue compared to the same
time period of 2017. More than 20 clinics in Germany have completed the reimbursement
negotiations with the German health insurance companies and have
now established a satisfactory overall reimbursement amount for the
Reducer procedure, while others are either in the negotiation
process or will negotiate later this year, per pre-set negotiation
cycles. One of the drivers behind this success is the NUB 1 status
for new therapies in Germany,
which the Reducer received at the end of January 2018.
In October 2018, the Company
announced that the U.S. Food and Drug Administration (the "FDA")
has granted "Breakthrough Device Designation" for the
Reducer. The FDA grants this designation in order to expedite
the development and review of a device that demonstrates compelling
potential to provide a more effective treatment or diagnosis for
life-threatening or irreversibly debilitating diseases. The Company
is working closely with FDA through this process.
In July 2018, the Company
announced that the first U.S. patient has been implanted with a
Reducer for the treatment of refractory angina. The Compassionate
Use case was conducted by Dr. Gerald
Koenig, along with Dr. Ryan
Gindi and colleagues, of the Division of Cardiology at Henry
Ford Hospital in Detroit,
Michigan. The Company recently announced that the patient
was no longer experiencing the very debilitating symptoms of severe
refractory angina, as reported by the physicians at the 12-week
follow-up appointment.
Results for the three months ended September 30, 2018 and 2017
Revenues
Revenues decreased 65% to $480,540 for the three months ended September 30, 2018, compared to revenues of
$1,374,893 for the same period in
2017. In December 2017, the Company
closed its contract manufacturing and consulting services business
and is now focused on the commercialization of its own product, the
Reducer.
Sales of the Reducer for the three months ended September 30, 2018 were $480,540 compared to $334,208 for the same period in 2017,
representing an increase of 44%. The Company is encouraged by the
progress this year, but recognizes that future revenues may be
unstable before the Reducer becomes widely adopted. The continued
success of the commercialization of the Reducer will be dependent
on the amount of internal resources allocated to the product,
obtaining appropriate reimbursement codes in various territories
and correctly managing the referrals process.
Cost of Goods Sold
The cost of goods sold for the
three months ended September 30, 2018
was $96,743 compared to $659,686 for the same period in 2017. The overall
gross margin for the three months ended September 30, 2018 was 80%, compared to 52% gross
margin for the same period in 2017. The gross margin now
reflects the gross margin on the Reducer product only, whereas the
comparable period included contract manufacturing and consulting
services.
Expenses
Total expenses for the three months ended
September 30, 2018 were $8,654,600, compared to $6,540,734 for the same period in 2017,
representing an increase of $2,113,866 or 32%. The increase in total
expenses for the three months ended September 30, 2018 compared to the same period in
2017 can be substantially explained by a $3,096,655 increase in general and administrative
expenses due to a $1,406,822 increase
in stock based compensation, as incentive grants were made during
the third quarter of 2018 and a $1,000,000 charge for collaboration and
settlement expenses (see "Contingencies" in the Management's
Discussion and Analysis for the quarter ended September 30, 2018) offset by a $931,945 decrease in product development and
clinical trial expenses as we continue to preserve cash
resources.
Selling expenses for the three months ended September 30, 2018 were $202,947, compared to $253,791 for the same period in 2017,
representing a decrease of $50,844,
or 20%. The decrease in selling expenses for the three months ended
September 30, 2018 compared to the
same period in 2017 reflects a decrease in costs incurred for
commercialization activities related to the Reducer as we have
reduced our attendance at conferences during the quarter. The
Company continues to minimize its selling expenses as the cash
resources of the Company are still limited.
General and administrative expenses for the three months ended
September 30, 2018 were $4,960,957, compared to $1,864,302 for the same period in 2017,
representing an increase of $3,096,655 or 166%. The increase in general
and administrative expenses for the three months ended September 30, 2018 compared to the same period in
2017 can be substantially explained by a $1,406,822 increase in share-based payments (as
the option awards in 2018 were higher in quantity and value than in
2017), a $1,000,000 increase in
collaboration and settlement expenses, and a $892,535 increase in other expense offset by a
$471,993 decrease in litigation
expenses (as there are fewer ongoing litigation matters).
Product development and clinical trial expenses for the three
months ended September 30, 2018 were
$3,490,696 compared to $4,422,641 for the same period in 2017,
representing a decrease of $931,945
or 21%. The decrease in product development and clinical trial
expenses for the three months ended September 30, 2018 was the result of a
$294,331 decrease in employee
expenses due to restructuring of the Company and a $481,747 decrease in other expenses, as the
Company continues to control costs.
The Company's expenses are subject to inflation and cost
increases. The Company has not seen a material increase in
the price of any of the components used in the manufacture of its
products and services.
Other Income and Loss
The other loss for the three
months ended September 30, 2018 was
$4,932,151 compared to other income
of $1,473,493 for the same period in
2017, an adverse change of $6,405,644. The increase in the other loss
can be substantially explained by the accounting treatment of the
2017 Financings (as defined below) resulting in charges of
$5,026,218 in the quarter and a
$1,550,719 net reduction in foreign
exchange gains received in the same quarter last year.
Losses
The operating losses and comprehensive losses
for the nine months ended September 30,
2018 were $118,283,093 and
$118,515,403 respectively, or
$10.46 basic and diluted loss per
share, as compared with losses of $17,882,255 and $19,832,651, respectively, or $22.68 basic and diluted loss per share, for the
same period in 2017.
The $98,682,752 increase in the
comprehensive loss incurred for the nine months ended September 30, 2018 compared to the same period in
2017 can be substantially explained by the accounting treatment of
the 2017 Financings (as defined below) resulting in charges of
$97,599,557 and a $2,277,278 increase in general and administrative
expenses (including a $754,640
increase in stock based compensation, as incentive grants were made
during the third quarter of 2018 and a $1,000,000 charge for collaboration and
settlement expenses).
Discussion of Liquidity and Capital Resources
Neovasc
finances its operations and capital expenditures with cash
generated from operations and through equity and debt
financings. As at September 30,
2018 the Company had cash and cash equivalents of
$14,487,483 compared to cash and cash
equivalents of $17,507,157 as at
December 31, 2017. The Company
will require significant additional financing in order to continue
to operate its business. Given the current nature of the
Company's capital structure, there can be no assurance that such
financing will be available on favorable terms, or at all.
The Company is in a positive working capital position of
$12,259,606, with current assets of
$15,972,965 and current liabilities
of $3,713,359. However, of the
current liabilities, only $2,739,433
are cash liabilities, the liability for the convertible Notes and
the derivative liability from the 2017 Financings are accounting
entries to account for the value of the instruments issued in the
2017 Financings (as defined below). The Company will require
additional working capital in order to continue to operate its
business and there can be no assurance that such additional working
capital will be available on favorable terms, or at all.
Cash used in operating activities for the nine months ended
September 30, 2018, was $16,822,109, compared to $14,242,747 for the same period in 2017.
For the nine months ended September 30,
2018, operating expenses were $17,729,515, compared to $14,627,842 for the same period in 2017, an
increase of $3,101,673 that can be
explained by a $1,000,000 charge for
collaboration and settlement expenses in 2018 (see 'Contingencies'
in the Management's Discussion and Analysis for the quarter ended
September 30, 2018) and a
$867,402 reduction in gross profit as
the Company ended its contract manufacturing and consulting
services at the end of 2017. Net cash provided from the net
change in non-cash working capital items for the nine months ended
September 30, 2018 was $938,010, compared to a net cash outflow of
$462,544 in the same period in
2017. The increase in net cash inflow can be attributed to a
change in the balance sheet structure as the Company closed its
consulting services and contract manufacturing businesses.
Net cash received from investing activities for the nine months
ended September 30, 2018 was
$715,848 compared to net cash applied
to investing activities of $767,372
for the same period in 2017, primarily due to the receipt of
proceeds from the sale of assets of $865,610, and a $282,214 decrease in purchase of property, plant
and equipment, as there is still a requirement to preserve cash
resources in 2018.
Outstanding Share Data
As at November 12, 2018, the Company had 24,978,892
common voting shares issued and outstanding. Further, the following
securities are convertible into Common Shares: 2,801,137 stock
options with a weighted average price of $2.10, 58,381,846 warrants and $17,510,000 principal amount of Notes, which
could convert into 7,663,953 Common Shares (not taking
into account the alternate conversion price mechanism). Our fully
diluted share capital as of the same date is 34,546,872. Our fully
diluted share capital, adjusted on the assumption that all the
issuable Series B Warrants are exercised using the cashless
alternative net number mechanism and the outstanding Notes are
exercised using the alternate conversion price at the closing price
on November 12, 2018 is
37,717,535.
Nasdaq Listing
On October 9,
2018, Neovasc received notice from the Nasdaq Hearings Panel
that the Company regained compliance with the minimum bid price
requirement for the Company's continued listing on the Nasdaq
Capital Market. Accordingly, Neovasc is in compliance with all
applicable Nasdaq listing standards and the Company considers this
matter closed.
For description of the terms of the securities issued pursuant
to the 2017 Financings, see the forms of warrants and note
previously filed on SEDAR and with the SEC on Form 6-K and the
prospectus supplement previously filed on SEDAR and with the SEC.
For a description of the risks associated with the securities
issued pursuant to the 2017 Financings, the amount of such
securities exercised or converted to date, the dilution to date
caused by such exercises and conversions, and the potential
dilution in the future due to such exercises and conversions, see
the Company's Annual Report on Form 20-F, which is available on
SEDAR at www.sedar.com and as filed with the SEC at
www.sec.gov.
The Company prepares its consolidated financial statements in
accordance with International Financial Reporting Standards, as
issued by the International Accounting Standards Board.
Neovasc's 2017 Annual Report on Form 20-F, Management's
Discussion and Analysis and Consolidated Financial Statements and
related notes are posted on the Company's website at
www.neovasc.com and were filed on SEDAR and with the SEC. In
addition to the summary contained herein, readers are encouraged to
review the full disclosure in these documents.
Conference Call and Webcast information
Neovasc will
be hosting a conference call today at 4:30
pm ET to discuss these results. To participate in the
conference call, please dial 855-283-1097 (domestic) or
323-794-2575 (international) and use passcode 7885315#.
A recording of the call will be available until November 28, 2018 by calling 844-512-2921
(domestic) or 412-317-6671 (international) and using passcode
7885315#. A link to the live and archived audio webcast of the
conference call will also be available on the Presentations and
Events page of the Investors section of Neovasc's website at
www.neovasc.com.
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 the 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 the Tiara, for the transcatheter treatment of mitral valve
disease, which is currently under clinical investigation in
the United States , Canada and Europe . For more information, visit:
www.neovasc.com.
Forward Looking Statements
This news release contains
forward-looking statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995 and applicable Canadian
securities laws regarding the Company's strategy and expectations
regarding delivering on future milestones for both product
platforms, beliefs as to the ability to increase enrollment for our
TIARA-II study in Europe, plans to
finalize the trans-septal Tiara system design concept during Q1,
2019, future reimbursement negotiations with German health
insurance companies for the Reducer and the growth of the
cardiovascular marketplace. Words and phrases such as "believes",
"may", "can", "could", "scheduled" and "will", and similar words or
expressions, are intended to identify these forward-looking
statements. 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 and
assumptions could cause the Company's actual results, performance
or achievements to differ materially from those expressed or
implied by the forward-looking statements, including, without
limitation, the substantial doubt about the Company's ability to
continue as a going concern; risks relating to the warrants (the
"Warrants") and senior secured convertible notes (the "Notes")
issued pursuant to the November 2017
underwritten public offering and concurrent private placement
(together, the "2017 Financings"), resulting in significant
dilution to the Company's shareholders; risks relating to the
Company's need for significant additional future capital and the
Company's ability to raise additional funding; risks relating to
cashless exercise and adjustment provisions in the Warrants and
Notes issued pursuant to the 2017 Financings, which could make it
more difficult and expensive for the Company to raise additional
capital in the future and result in further dilution to investors;
risks relating to the sale of a significant number of common shares
of the Company; risks relating to the exercise of Warrants or
conversion of Notes issued pursuant to the 2017 Financings, which
may encourage short sales by third parties; risks relating to the
possibility that the Company's common shares may be delisted from
the Nasdaq Capital Market or the Toronto Stock Exchange, which
could affect their market price and liquidity; risks relating to
the Company's common share price being volatile; risks relating to
the influence of significant shareholders of the Company over the
Company's business operations and share price; risks relating to
the Company's significant indebtedness, and its effect on the
Company's financial condition; risks relating to claims by third
parties alleging infringement of their intellectual property
rights; risks relating to lawsuits that the Company is subject to,
which could divert the Company's resources and result in the
payment of significant damages and other remedies; the Company's
ability to establish, maintain and defend intellectual property
rights in the Company's products; risks relating to results from
clinical trials of the Company's products, which may be unfavorable
or perceived as unfavorable; the Company's history of losses and
significant accumulated deficit; risks associated with product
liability claims, insurance and recalls; risks relating to use of
the Company's products in unapproved circumstances, which could
expose the Company to liabilities; risks relating to competition in
the medical device industry, including the risk that one or more of
the Company's competitors may develop more effective or more
affordable products; risks relating to the Company's ability to
achieve or maintain expected levels of market acceptance for the
Company's products, as well as the Company's ability to
successfully build its in-house sales capabilities or secure
third-party marketing or distribution partners; the Company's
ability to convince public payors and hospitals to include the
Company's products on their approved products lists; risks relating
to new legislation, new regulatory requirements and the efforts of
governmental and third-party payors to contain or reduce the costs
of healthcare; risks relating to increased regulation, enforcement
and inspections of participants in the medical device industry,
including frequent government investigations into marketing and
other business practices; risks associated with the extensive
regulation of the Company's products and trials by governmental
authorities, as well as the cost and time delays associated
therewith; risks associated with post-market regulation of the
Company's products; health and safety risks associated with the
Company's products and industry; risks associated with the
Company's manufacturing operations, including the regulation of the
Company's manufacturing processes by governmental authorities and
the availability of two critical components of the Reducer; risk of
animal disease associated with the use of the Company's products;
risks relating to the manufacturing capacity of third-party
manufacturers for the Company's products, including risks of supply
interruptions impacting the Company's ability to manufacture its
own products; risks relating to the Company's dependence on limited
products for substantially all of the Company's current revenues;
risks relating to the Company's exposure to adverse movements in
foreign currency exchange rates; risks relating to the possibility
that the Company could lose its foreign private issuer status under
U.S. federal securities laws; risks relating to breaches of
anti-bribery laws by the Company's employees or agents; risks
associated with future changes in financial accounting standards
and new accounting pronouncements; risks relating to the Company's
dependence upon key personnel to achieve its business objectives;
the Company's ability to maintain strong relationships with
physicians; risks relating to the sufficiency of the Company's
management systems and resources in periods of significant growth;
risks associated with consolidation in the health care industry,
including the downward pressure on product pricing and the growing
need to be selected by larger customers in order to make sales to
their members or participants; risks relating to the Company's
ability to successfully identify and complete corporate
transactions on favorable terms or achieve anticipated synergies
relating to any acquisitions or alliances; risks relating to the
Company's ability to successfully enter into fundamental
transactions as defined in the Series C warrants issued pursuant to
the 2017 Financings; anti-takeover provisions in the Company's
constating documents which could discourage a third party from
making a takeover bid beneficial to the Company's shareholders; and
risks relating to conflicts of interests among the Company's
officers and directors as a result of their involvement with other
issuers. 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 Management's Discussion
and Analysis for the quarter ended September
30, 2018 (copies of which may be obtained at www.sedar.com
or www.sec.gov). The Company has no intention and undertakes no
obligation to update or revise any forward-looking statements
beyond required periodic filings with securities regulators,
whether as a result of new information, future events or otherwise,
except as required by law.
NEOVASC
INC.
|
|
|
|
|
Condensed Interim
Consolidated Statements of Financial
Position
|
|
|
|
|
(Expressed in U.S.
dollars) (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
2018
|
|
December
31,
2017
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
$
|
14,487,483
|
$
|
17,507,157
|
Accounts
receivable
|
|
802,368
|
|
1,334,923
|
Inventory
|
|
190,182
|
|
398,556
|
Prepaid expenses and
other assets
|
|
492,932
|
|
802,366
|
Total
current assets
|
|
15,972,965
|
|
20,043,002
|
|
|
|
|
|
Non-current
assets
|
|
|
|
|
Restricted
cash
|
|
464,306
|
|
478,260
|
Property, plant and
equipment
|
|
940,283
|
|
1,685,181
|
Total
non-current assets
|
|
1,404,589
|
|
2,163,441
|
|
|
|
|
|
Total
assets
|
$
|
17,377,554
|
$
|
22,206,443
|
|
|
|
|
|
LIABILITIES AND
EQUITY
|
|
|
|
|
Liabilities
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
2,739,433
|
$
|
1,844,955
|
Convertible
Note
|
|
645,943
|
|
4,261,597
|
Derivative liability
from financing
|
|
327,983
|
|
19,997,345
|
Total
current liabilities
|
|
3,713,359
|
|
26,103,897
|
|
|
|
|
|
Non-Current
Liabilities
|
|
|
|
|
Convertible
Note
|
|
27,867,007
|
|
15,745,962
|
Derivative liability
from financing
|
|
489,239
|
|
16,831,685
|
Total non-current
liabilities
|
|
28,356,246
|
|
32,577,647
|
|
|
|
|
|
Total
liabilities
|
$
|
32,069,605
|
$
|
58,681,544
|
|
|
|
|
|
Equity
|
|
|
|
|
Share
capital
|
$
|
310,317,605
|
$
|
171,803,816
|
Contributed
surplus
|
|
24,841,510
|
|
23,056,846
|
Accumulated other
comprehensive loss
|
|
(6,875,746)
|
|
(6,643,436)
|
Deficit
|
|
(342,975,420)
|
|
(224,692,327)
|
Total
equity
|
|
(14,692,051)
|
|
(36,475,101)
|
|
|
|
|
|
Total liabilities
and equity
|
$
|
17,377,554
|
$
|
22,206,443
|
NEOVASC
INC.
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Condensed Interim
Consolidated Statements of Loss and Comprehensive Loss
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For the three and
nine months ended September 30,
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(Expressed in U.S.
dollars) (Unaudited)
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For the three months
ended
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For the nine months
ended
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September
30,
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September
30,
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2018
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2017
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2018
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2017
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REVENUE
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Reducer
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$
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480,540
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$
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334,208
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$
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1,225,709
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$
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842,528
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Contract
manufacturing and consulting services
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-
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1,040,685
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-
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3,318,861
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480,540
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1,374,893
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1,225,709
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4,161,389
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COST OF GOODS
SOLD
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96,743
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659,686
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272,739
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2,341,017
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GROSS
PROFIT
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383,797
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715,207
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952,970
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1,820,372
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EXPENSES
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Selling
expenses
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202,947
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253,791
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738,423
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665,341
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General and
administrative expenses
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4,960,957
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1,864,302
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9,643,512
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7,366,234
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Product development
and clinical trials expenses
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3,490,696
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4,422,641
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11,348,342
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13,726,944
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8,654,600
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6,540,734
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21,730,277
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21,758,519
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OPERATING
LOSS
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(8,270,803)
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(5,825,527)
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(20,777,307)
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(19,938,147)
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OTHER
(EXPENSE)/INCOME
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Interest
income
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93,313
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138,613
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147,450
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355,837
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Gain on sale of
assets
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-
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-
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238,907
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-
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Gain/(loss) on
foreign exchange
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754
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(8,951,113)
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(114,532)
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(5,661,951)
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Unrealized loss on
derivative liability and
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convertible
note
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(4,536,268)
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-
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(8,270,500)
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-
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Realized gain/(loss)
on exercise of warrants
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887,580
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-
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(43,127,218)
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-
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Amortization of
deferred loss
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(1,377,530)
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-
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(46,201,839)
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-
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Interest on damages
provision
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-
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(216,593)
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-
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(642,716)
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Unrealized gain on
damages provision
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-
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10,502,586
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-
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8,463,548
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(4,932,151)
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1,473,493
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(97,327,732)
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2,514,718
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LOSS BEFORE
TAX
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(13,202,954)
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(4,352,034)
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(118,105,039)
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(17,423,429)
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Tax
expense
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(54,000)
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(343,926)
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(178,054)
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(458,826)
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LOSS FOR THE
PERIOD
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$
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(13,256,954)
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$
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(4,695,960)
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$
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(118,283,093)
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$
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(17,882,255)
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OTHER
COMPREHENSIVE INCOME FOR THE
PERIOD
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Exchange difference
on translation
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-
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9,390,710
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-
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6,513,152
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Unrealized gain on
damages provision
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-
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(10,502,586)
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-
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(8,463,548)
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Fair market value
changes in convertible note due to changes in own credit
risk
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346,327
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-
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(232,310)
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-
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346,327
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(1,111,876)
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(232,310)
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(1,950,396)
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LOSS AND OTHER
COMPREHENSIVE LOSS FOR
THE PERIOD
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$
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(12,910,627)
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$
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(5,807,836)
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$
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(118,515,403)
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$
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(19,832,651)
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LOSS PER
SHARE
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Basic and diluted
loss per share
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$
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(0.70)
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$
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(5.95)
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$
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(10.46)
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$
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(22.68)
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View original
content:http://www.prnewswire.com/news-releases/neovasc-announces-third-quarter-2018-financial-results-300750271.html
SOURCE Neovasc Inc.