SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of
|
|
March
|
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2017
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Commission File Number
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001-36458
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Neovasc Inc.
|
(Translation of registrant’s name into English)
|
Suite 5138
– 13562 Maycrest Way
Richmond,
British Columbia, Canada V6V 2J7
|
(Address of principal executive offices)
|
Indicate by check mark whether the registrant files
or will file annual reports under cover of Form 20-F or Form 40-F:
Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting
the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
DOCUMENTS INCLUDED AS PART OF THIS REPORT
Document
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1
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News
Release dated March 23, 2017 - Neovasc Announces Results for the Fourth Quarter and Fiscal Year 2016
|
Document 1
Neovasc Announces Results for the Fourth Quarter and
Fiscal Year 2016
NASDAQ, TSX: NVCN
VANCOUVER, March 23, 2017 /CNW/ - Neovasc Inc. ("
Neovasc
"
or the "
Company
") (NASDAQ, TSX: NVCN) today announced financial results for the quarter and year ended December
31, 2016 (all figures in U.S. dollars unless otherwise indicated).
"While the ongoing litigation continued to dominate the
Company's narrative in 2016, we expect to know the outcome of our U.S. appeal later this year, bringing closure to this chapter
in the Company's development," commented Neovasc CEO, Alexei Marko. "The evidence stemming from the 26 cases of
the Tiara's use and the hundreds of commercial cases with Reducer underscore for us that we remain on a path to advancing the standard
of care for mitral regurgitation and refractory angina and improving the quality of life for patients suffering from these devastating
diseases."
The Company's proprietary product for treating mitral valve
disease, Tiara™, continues to perform well and has now been used to treat 26 patients under both early feasibility and compassionate
use cases across North America and Europe. Implantation is completed through a short trans-apical procedure and typically
results in complete resolution of the patient's mitral regurgitation without significant residual leaks or obstruction of the ventricular
outflow tract. The 30-day survival rate for the first 24 patients (those treated more than 30 days ago) is 21 of 24 or 88%
and there has been no 30-day mortality observed in any of the last 15 patients. One patient is now over three years post
implant. The Company expects to begin enrolling patients in the coming weeks into its European CE Mark trial, with initial
cases in Italy.
Sales of the Neovasc Reducer™ ("Reducer"),
the Company's innovative device to treat refractory angina, grew 91% year over year in 2016. There has been steady growth
in the adoption of the product as implanting physicians see many of their patients who were refractory to other angina treatments
returning with significant improvement in symptoms following implantation with Reducer.
Results for the quarters ended December 31, 2016 and 2015
Revenues
Revenues for the quarter ended December 31, 2016 were $2,761,122 compared to $2,224,046 for the same period in 2015. Reducer
revenues increased by 47% to $282,515 for the quarter ended December 31, 2016 compared to $192,013, for the same period in 2015.
Contract manufacturing and consulting services revenues were slightly increased in comparison to the same period in 2015. Due
to a recent agreement with Boston Scientific Corporation ("Boston Scientific") the Company expects a decline in revenue
in the coming periods. This is consistent with the Company's strategy to focus its business towards development and commercialization
of its own products, the Reducer and the Tiara.
In December 2016, the Company entered into an agreement for
Boston Scientific to acquire the Company's advanced biologic tissue capabilities and certain manufacturing assets and make a 15%
equity investment in Neovasc, for a total of $75 million in cash. Under the terms of the approximate $68 million
asset purchase agreement the Company has been granted a license to the purchased trade secrets and know-how and access to the sold
facilities to allow it to continue its tissue and valve assembly activities for its remaining customers, and continue its own tissue-related
programs, including advancing the Tiara through its clinical and regulatory pathways.
Cost of Goods Sold
The cost of goods sold for the quarter ended December 31, 2016 was $2,052,969, compared to $1,942,140 for the same period in 2015.
The gross margin for the quarter ended December 31, 2016 was 26%, compared to 13% for the same period in 2015. In 2015, the
Company issued a credit note to a single customer, which reduced margins from 23% to 13% for the fourth quarter of 2015.
Expenses
Total expenses for the quarter ended December 31, 2016 were $7,437,156, compared to $8,352,093 for the same period in 2015, representing
a decrease of 11%. The decrease results from a $1,037,249 decrease in general and administrative expenses offset by a $273,035
increase in clinical trial and product development expenses for the Company's two new product development programs.
Selling expenses were $141,733 for the quarter ended December
31, 2016, compared to $292,456 for the same period in 2015, representing a decrease of 52%, due to lower sales consulting, less
travel and lower stock compensation costs in 2016. General and administrative expenses were $2,461,433 for the quarter ended
December 31, 2016, compared to $3,498,682 for the same period in 2015, representing a decrease of 30%, due to a decrease in litigation
expenses of $537,872 and a $296,782 decrease in share-based payments. Product development and clinical trials expenses were
$4,833,990 for the quarter ended December 31, 2016, compared to $4,560,955 for the same period in 2015 representing an increase
of 6% due to an increased investment in the Tiara development program.
Losses
The net profit for the quarter ended December 31, 2016 was $37,213,791, or $0.54 basic earnings and $0.47 fully diluted earnings
per share, compared with a loss of $7,383,608, or $0.11 basic and diluted loss per share for the same period in 2015.
Results for the years ended December 31, 2016 and 2015
Revenues
Revenues decreased 4% year-over-year to $9,512,796 for the year ended December 31, 2016, compared to revenues of $9,929,940 for
the same period in 2015. The reduction is primarily due to the decrease in surgical patch sales. The Company ceased
its production of surgical patches (product sales) in the second quarter of 2015.
Reducer sales for the year ended December 31, 2016 were $1,004,948,
compared to $526,412 for the same period in 2015, representing an increase of 91%. The Company started its sales of the Reducer
in the first quarter of 2015 as it initiated its focused commercialization of the product in Europe.
Contract manufacturing revenues for the year ended December
31, 2016 were $3,746,521, compared to $3,236,978 for the same period in 2015, representing an increase of 16%. The increase
in revenue for the year ended December 31, 2016 compared to the same period in 2015 is primarily due to growing revenues from Boston
Scientific. The Company believes that contract manufacturing revenues will decline in 2017 with the loss of Boston Scientific
as a customer and recognizes that these revenues will be derived from a smaller customer base as the transcatheter aortic valve
market matures.
Revenues from consulting services for the year ended December
31, 2016 were $4,761,327, compared to $5,812,814 for the same period in 2015, representing a decrease of 18%. The reduction
is indicative of the trend the Company is seeing in consulting service revenue. The Company anticipates that its consulting
services revenue will decline in the long-term as its consulting customers continue to transition to becoming contract manufacturing
customers or cease to be customers at all.
Cost of Goods Sold
The cost of goods sold for the year ended December 31, 2016 was $7,091,761, compared to $6,938,134 for the same period in 2015.
The overall gross margin for the year ended December 31, 2016 was 25%, compared to 30% gross margin for the same period in 2015.
The Company has seen its gross margins decline due to a change in the product mix. The lower margin the Company has received
on its sales to Boston Scientific are only partially offset by the higher margins on the Reducer revenue.
Expenses
Total expenses for the year ended December 31, 2016 were $39,243,928, compared to $31,750,140 for the same period in 2015, representing
an increase of $7,493,788 or 24%. The increase in total expenses for the year ended December 31, 2016 compared to the same
period in 2015 is primarily due to a $5,269,711 increase in general and administrative expenses (of which $6,111,912 relates to
an increase in litigation expenses) and a $2,183,108 increase in product development and clinical trial expenses to advance the
Tiara and Reducer development programs.
Selling expenses for the year ended December 31, 2016 were
$696,638, compared to $655,669 for the same period in 2015, representing an increase of $40,969, or 6%. The increase in selling
expenses for the year ended December 31, 2016 compared to the same period in 2015 reflects costs incurred in connection with commercialization
activities for the Reducer in 2016. The Company has minimized its increase in selling expenses in the light of higher litigation
costs and the impact of litigation on the Company.
General and administrative expenses for the year ended December
31, 2016 were $19,182,787 compared to $13,913,076 for the same period in 2015, representing an increase of $5,269,711, or 38%.
The increase in general and administrative expenses for the year ended December 31, 2016 compared to the same period in 2015 can
be substantially explained by a $6,111,912 increase in litigation expenses, offset by a $813,075 decrease in share-based payments.
In 2016 the Company adjusted its compensation plan to directors, officers and senior management, decreasing the number of options
granted by 75%, replacing these options with a smaller cash based bonus plan and increasing officers and senior management's base
salaries by 10%.
Product development and clinical trial expenses for the year
ended December 31, 2016 were $19,364,503, compared to $17,181,395 for the same period in 2015, representing an increase of $2,183,108,
or 13%. The increase in product development and clinical trial expenses for the year ended December 31, 2016 was due to a
$1,183,962 increase in cash–based employee expenses as the Company hired additional staff to advance product development
and a $2,076,259 increase in other expenses as the Company invested in its two major new product initiatives, offset by a $1,243,976
decrease in share-based payments.
Other Income and Loss
The other loss for the year ended December 31, 2016 was $49,471,477, compared to other income of $2,195,195 for the same period
in 2015, a change of $51,666,672. This amount is made up of the $111,781,096 damages provision related to the litigation
with CardiAQ Valve Technologies Inc. ("CardiAQ"), a $2,690,129 increase in the unrealized loss on the damages provision
and a $1,894,473 increase in the loss on foreign exchange, offset by a $65,095,733 gain on sale of assets related to the agreement
with Boston Scientific.
Losses
The operating losses and comprehensive losses for the year ended December 31, 2016 were $86,494,893 and $82,397,922 respectively,
or $1.28 basic and diluted loss per share, as compared with losses of $26,730,490 and $35,116,695, or $0.41 basic and diluted loss
per share for the same period in 2015. Litigation expenses for the year ended December 31, 2016 represent a loss of $0.20 basic
and diluted loss per share compared to a loss of $0.11 basic and diluted loss per share for the same period in 2015. The
Company has incurred significant costs in defending itself in lawsuits filed by CardiAQ. Total litigation costs since the
initial claims were filed in June 2015 are approximately $21.06 million and the Company may require an additional $1-3 million
to cover additional litigation expenses up to and including the appeal hearing, currently scheduled for August 2017.
Discussion of Liquidity and Capital Resources
Neovasc finances its operations and capital expenditures with cash generated from operations and equity financings. As at
December 31, 2016 the Company had cash and cash equivalents of $22,954,571 compared to cash and cash equivalents of $55,026,171
as at December 31, 2015.
The Company's working capital deficit is $17,497,931 as at
December 31, 2016 compared to a working capital surplus of $54,274,867 as at December 31, 2015. Unless the Company is successful
in an appeal of the verdict, or otherwise is successful in reducing the amount of the approximate $112 million damages award to
an amount less that the $70 million held in escrow, the Company will require significant additional financing in order to pay the
damages and to continue to operate its business. There can be no assurance that such financing will be available on favorable
terms, or at all. The Company may be faced with significant monetary damages that could exceed its resources and/or the loss of
intellectual property rights that could have a material adverse effect on the Company and its financial condition. These
circumstances create material uncertainty and cast substantial doubt about the Company's ability to continue as a going concern.
Cash used in operating activities for the year ended December
31, 2016 was $39,794,159, compared to $21,282,958 for the same period in 2015. For the year ended December 31, 2016, operating
expenses were $37,215,852, compared to $22,693,678 for the same period in 2015. The cash expenditures on litigation (litigation
expenses less change in accounts payable related to litigation) were approximately $13.1 million and cash expenditures on research
and development and clinical trials (expenses less share based payments and depreciation and less change in accounts payable related
to research and development) were approximately $17.9 million. Working capital items absorbed cash of $2,427,075, compared
to working capital items generating cash of $821,165 for the same period in 2015. This was principally due to an increase
in accounts receivable which absorbed cash due at year end due to a final payment received immediately after the year end from
Boston Scientific and a decrease in accounts payable and accrued liabilities as operational activities declined.
Outstanding Share Data
As at March 23, 2017, the Company had 78,699,345 common voting shares issued and outstanding. Further, the following securities
are convertible into common shares of the Company: 7,800,680 stock options with a weighted average price of C$4.72. The fully
diluted share capital of the Company at March 23, 2017 is 86,500,025.
Neovasc's 2016 audited consolidated financial statements and
notes thereto, its Management's Discussion and Analysis and its Annual Information Form will be posted on the Company's website
at www.neovasc.com and will be filed on SEDAR. Neovasc's annual report on Form 40-F will be available on EDGAR.
In addition to the summary contained herein, readers are encouraged to review the full disclosure in Neovasc's 2016 audited
consolidated financial statements and notes thereto and Management's Discussion and Analysis.
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,
dial 888 390 0546 or 416 764 8688. A recording of the call will be available for 72 hours by calling 888 390 0541 or 416
764 8677 and using passcode 034470#. 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.
NEOVASC INC.
|
Consolidated Statements of Financial Position
|
As at December 31,
|
(Expressed in United States dollars)
|
|
|
|
|
|
|
|
|
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
22,954,571
|
$
|
55,026,171
|
|
|
|
Cash held in escrow
|
|
|
70,000,000
|
|
-
|
|
|
|
Accounts receivable
|
|
|
3,117,474
|
|
1,736,941
|
|
|
|
Inventory
|
|
|
196,723
|
|
598,136
|
|
|
|
Prepaid expenses and other assets
|
|
|
505,340
|
|
146,590
|
|
|
Total current assets
|
|
|
96,774,108
|
|
57,507,838
|
|
|
|
|
|
|
|
|
|
Non-current assets
|
|
|
|
|
|
|
|
|
Restricted cash
|
|
|
449,760
|
|
-
|
|
|
|
Property, plant and equipment
|
|
|
1,585,635
|
|
3,720,556
|
|
|
Total non-current assets
|
|
|
2,035,395
|
|
3,720,556
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
98,809,503
|
$
|
61,228,394
|
|
|
|
|
|
|
|
|
LIABILITIES AND EQUITY
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
|
$2,490,943
|
|
$3,232,971
|
|
|
|
Damages provision
|
|
|
111,781,096
|
|
-
|
|
|
Total current liabilities and total liabilities
|
|
|
114,272,039
|
|
3,232,971
|
|
|
|
|
|
|
|
|
|
Equity
|
|
|
|
|
|
|
|
|
Share capital
|
|
|
168,712,673
|
|
161,505,037
|
|
|
|
Contributed surplus
|
|
|
22,301,437
|
|
20,569,110
|
|
|
|
Accumulated other comprehensive loss
|
|
|
(4,693,040)
|
|
(8,790,011)
|
|
|
|
Deficit
|
|
|
(201,783,606)
|
|
(115,288,713)
|
|
|
Total equity
|
|
|
(15,462,536)
|
|
57,995,423
|
|
|
|
|
|
|
|
|
Total liabilities and equity
|
|
$
|
98,809,503
|
$
|
61,228,394
|
|
NEOVASC INC.
|
Consolidated Statements of Loss and Comprehensive Loss
|
For the years ended December 31,
|
(Expressed in United States dollars)
|
|
|
|
|
|
|
|
2016
|
|
2015
|
|
|
|
|
|
REVENUE
|
|
|
|
|
Reducer
|
$
|
1,004,948
|
$
|
526,412
|
Product sales
|
|
-
|
|
353,736
|
Contract manufacturing
|
|
3,746,521
|
|
3,236,978
|
Consulting services
|
|
4,761,327
|
|
5,812,814
|
|
|
9,512,796
|
|
9,929,940
|
|
|
|
|
|
COST OF GOODS SOLD
|
|
7,091,761
|
|
6,938,134
|
GROSS PROFIT
|
|
2,421,035
|
|
2,991,806
|
|
|
|
|
|
EXPENSES
|
|
|
|
|
Selling expenses
|
|
696,638
|
|
655,669
|
General and administrative expenses
|
|
19,182,787
|
|
13,913,076
|
Product development and clinical trials expenses
|
|
19,364,503
|
|
17,181,395
|
|
|
39,243,928
|
|
31,750,140
|
|
|
|
|
|
OPERATING LOSS
|
|
(36,822,893)
|
|
(28,758,334)
|
|
|
|
|
|
OTHER INCOME/(EXPENSE)
|
|
|
|
|
Interest income
|
|
177,761
|
|
577,006
|
Interest expense
|
|
-
|
|
(2,538)
|
Damages provision
|
|
(111,781,096)
|
|
-
|
Gain on sale of assets
|
|
65,095,733
|
|
-
|
(Loss)/gain on foreign exchange
|
|
(273,746)
|
|
1,620,727
|
Unrealized foreign exchange loss on damages provision
|
|
(2,690,129)
|
|
-
|
|
|
(49,471,477)
|
|
2,195,195
|
LOSS BEFORE TAX
|
|
(86,294,370)
|
|
(26,563,139)
|
|
|
|
|
|
Tax expense
|
|
(200,523)
|
|
(167,351)
|
|
|
|
|
|
LOSS FOR THE YEAR
|
$
|
(86,494,893)
|
$
|
(26,730,490)
|
|
|
|
|
|
OTHER COMPREHENSIVE GAIN (LOSS) FOR THE YEAR
|
|
|
|
|
Items that will be reclassified subsequently to profit or loss
|
|
|
|
|
Exchange difference on translation for other than damages provision
|
|
1,406,842
|
|
(8,386,205)
|
Exchange difference on translation for damages provision
|
|
2,690,129
|
|
-
|
|
|
4,096,971
|
|
(8,386,205)
|
|
|
|
|
|
LOSS AND OTHER COMPREHENSIVE LOSS FOR THE YEAR
|
$
|
(82,397,922)
|
$
|
(35,116,695)
|
|
|
|
|
|
LOSS PER SHARE
|
|
|
|
|
Basic and diluted loss per share
|
$
|
(1.28)
|
$
|
(0.41)
|
NEOVASC INC.
|
Consolidated Statements of Cash Flows
|
For the years ended December 31,
|
(Expressed in United States dollars)
|
|
|
|
|
|
|
|
|
|
2016
|
|
2015
|
|
|
|
|
|
|
OPERATING ACTIVITIES
|
|
|
|
|
|
Loss for the year
|
|
$
|
(86,494,893)
|
$
|
(26,730,490)
|
Adjustments for:
|
|
|
|
|
|
|
Depreciation
|
|
|
755,734
|
|
503,709
|
|
Share-based payments
|
|
|
1,810,111
|
|
4,114,165
|
|
Damages provision
|
|
|
111,781,096
|
|
-
|
|
Gain on sale of assets
|
|
|
(65,095,733)
|
|
-
|
|
Write-down accounts receivable
|
|
|
5,071
|
|
25,893
|
|
Income tax expense
|
|
|
200,523
|
|
-
|
|
Interest income
|
|
|
(177,761)
|
|
(609,493)
|
|
Interest expense
|
|
|
-
|
|
2,538
|
|
|
|
(37,215,852)
|
|
(22,693,678)
|
|
|
|
|
|
|
Net change in non-cash working capital items:
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(1,362,272)
|
|
(468,478)
|
|
Inventory
|
|
|
(470)
|
|
(269,605)
|
|
Prepaid expenses and other assets
|
|
|
(221,973)
|
|
31,592
|
|
Accounts payable and accrued liabilities
|
|
|
(842,360)
|
|
1,527,656
|
|
|
|
(2,427,075)
|
|
821,165
|
|
|
|
|
|
|
Income tax and Interest paid and received:
|
|
|
|
|
|
|
Income tax paid
|
|
|
(326,492)
|
|
-
|
|
Interest received
|
|
|
175,260
|
|
592,093
|
|
Interest paid
|
|
|
-
|
|
(2,538)
|
|
|
|
(151,232)
|
|
589,555
|
|
|
|
|
|
|
Net cash applied to operating activities
|
|
|
(39,794,159)
|
|
(21,282,958)
|
|
|
|
|
|
|
INVESTING ACTIVITES
|
|
|
|
|
|
|
Increase in restricted cash
|
|
|
(449,760)
|
|
-
|
|
Increase in cash held in escrow
|
|
|
(70,000,000)
|
|
-
|
|
Redemption of guaranteed investment certificates
|
|
|
-
|
|
9,322,492
|
|
Purchase of property, plant and equipment
|
|
|
(656,170)
|
|
(2,143,128)
|
|
Proceeds from sale of assets, net of costs of $168,060
|
|
|
67,741,740
|
|
-
|
Net cash from / (applied to) investing activities
|
|
|
(3,364,190)
|
|
7,179,364
|
|
|
|
|
|
|
FINANCING ACTIVITIES
|
|
|
|
|
|
|
Repayment of long-term debt
|
|
|
-
|
|
(164,364)
|
|
Proceeds from private placement, net of costs of $35,540
|
|
|
7,054,660
|
|
69,879,210
|
|
Proceeds from exercise of options
|
|
|
75,192
|
|
1,090,092
|
Net cash from financing activities
|
|
|
7,192,852
|
|
70,804,938
|
|
|
|
|
|
|
NET CHANGE IN CASH AND CASH EQUIVALENTS
|
|
|
(36,028,497)
|
|
56,701,344
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS
|
|
|
|
|
|
Beginning of the year
|
|
|
55,026,171
|
|
5,193,561
|
Exchange difference on cash and cash equivalents
|
|
|
3,956,897
|
|
(6,868,734)
|
End of the year
|
|
$
|
22,954,571
|
$
|
55,026,171
|
|
|
|
|
|
|
Represented by:
|
|
|
|
|
|
Cash
|
|
|
13,961,537
|
|
7,860,728
|
Cashable high interest savings accounts
|
|
|
8,993,034
|
|
25,490,443
|
Cashable guaranteed investment certificates
|
|
|
-
|
|
21,675,000
|
|
|
$
|
22,954,571
|
$
|
55,026,171
|
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 Neovasc Reducer™, for the treatment of refractory angina which is not currently
available in the United States and has been available in Europe since 2015 and the Tiara™, for the transcatheter treatment
of mitral valve disease, which is currently under investigation in the United States, Canada and Europe. The Company also sells
a line of advanced biological tissue products that are used as key components in third-party medical products including transcatheter
heart valves. For more information, visit: www.neovasc.com.
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 relating to the
Company's plans and expectations concerning its business, financial results, trends, litigation and other matters, including the
Company's intentions and expectations relating to the CardiAQ litigation, significant monetary damages and required additional
financing that may result from the CardiAQ litigation, the Company's ability to continue as a going concern, additional CardiAQ
litigation expenses, the timing of patient enrollment in the European CE Mark trial, the decline of contract manufacturing and
consulting revenues in future periods, the focus of the Company's business toward development and commercialization of its own
products and the future success of the company in advancing the standard of care and quality of life for its patients. The words
"expect", "may", "believe", "continue", "remain", "strategy", and similar
words or expressions are intended to identify 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, risks relating to our litigation with CardiAQ, including
the Company's ability to successfully appeal the validity of the awards as well as the ruling on inventorship, which create material
uncertainty and which cast substantial doubt on our ability to continue as a going concern; the substantial doubt about our ability
to continue as a going concern; risks relating to our need for significant additional future capital and our ability to raise additional
funding; risks relating to claims by third parties alleging infringement of their intellectual property rights; our ability to
establish, maintain and defend intellectual property rights in our products; risks relating to results from clinical trials of
our products, which may be unfavorable or perceived as unfavorable; our history of losses and significant accumulated deficit;
risks associated with product liability claims, insurance and recalls; risks relating to competition in the medical device industry,
including the risk that one or more competitors may develop more effective or more affordable products; risks relating to our ability
to achieve or maintain expected levels of market acceptance for our products, as well as our ability to successfully build our
in-house sales capabilities or secure third-party marketing or distribution partners; our ability to convince public payors and
hospitals to include our 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 our products and trials by governmental
authorities, as well as the cost and time delays associated therewith; risks associated with post-market regulation of our products;
health and safety risks associated with our products and our industry; risks associated with our manufacturing operations, including
the regulation of our manufacturing processes by governmental authorities and the availability of two critical components of the
Reducer; risk of animal disease associated with the use of our products; risks relating to the manufacturing capacity of third-party
manufacturers for our products, including risks of supply interruptions impacting the Company's ability to manufacture its own
products; risks relating to breaches of anti-bribery laws by our employees or agents; risks associated with future changes in financial
accounting standards and new accounting pronouncements; our dependence upon key personnel to achieve our business objectives; our
ability to maintain strong relationships with physicians; risks relating to the sufficiency of our 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;
our ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating
to any acquisitions or alliances; anti-takeover provisions in our constating documents which could discourage a third party from
making a takeover bid beneficial to our shareholders; risks relating to conflicts of interests among the Company's officers and
directors as a result of their involvement with other issuers; and risks relating to the influence of significant shareholders
of the Company over our business operations and share price. These risk factors and others relating to the Company are discussed
in greater detail in the "Risk Factors" section of the Company's Annual Information Form, which is included in its Annual
Report on Form 40-F and Management's Discussion and Analysis of Financial Condition and Results of Operations (copies of which
filings 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, except
as required by law.
SOURCE Neovasc Inc.
To view the original version on PR Newswire, visit: http://www.newswire.ca/en/releases/archive/March2017/23/c7677.html
%CIK: 0001399708
For further information:
Investor Relations, Neovasc Inc.,
Chris Clark, 604 248-4138, cclark@neovasc.com
CO: Neovasc Inc.
CNW 16:00e 23-MAR-17
SIGNATURES
Pursuant to the requirements of the Securities Exchange
Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
Neovasc Inc.
|
|
(Registrant)
|
|
|
Date:
March 23, 2017
|
By:
|
/s/
Chris Clark
|
|
Name:
|
Chris Clark
|
|
Title:
|
Chief Financial Officer
|
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