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.