NASDAQ, TSX: NVCN
VANCOUVER, Aug. 10, 2017 /CNW/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ, TSX: NVCN)
today announced financial results for the second quarter
ended June 30, 2017 (all figures in U.S. dollars unless
otherwise indicated).
"For both the Tiara and Reducer, the quarter saw consistent
progress across North America and
Europe," commented Neovasc
CEO, Alexei Marko. "As we get closer to key decisions from the
U.S. Court of Appeals, our regulatory and commercial teams are
gaining momentum from both the clinical and commercial results our
innovative cardiovascular products are producing."
The Company's proprietary product for treating mitral valve
disease, the Tiara™ ("Tiara"), continues to perform well and has
now been used to treat 33 patients under early feasibility,
compassionate use and clinical study protocols across North
America and Europe. The 30-day survival rate for those
treated more than 30 days ago is 88%. The longest surviving patient
treated with Tiara is now almost three and half years' post
implant. The Company added additional sites to its CE Mark trial
during the quarter with UK approval, and is in the process of
adding additional sites in Italy,
Germany and the
U.S.
Implant procedures of the Neovasc Reducer™ ("Reducer"), the
Company's innovative device to treat refractory angina continued to
grow during the quarter. Since launch in 2015, close to 500
devices have been implanted at more than 73 centres and the Company
is now actively selling in 12 countries. The Company is also in
advanced discussions with the FDA to gain approval for a pivotal
U.S. study for Reducer.
Results for the quarters ended June 30, 2017 and
2016
Revenues
Revenues decreased 24% to $1,305,136 for the three months ended
June 30, 2017, compared to revenues
of $1,710,932 for the same period in
2016. The Company continues to focus its business away from its
traditional revenue streams towards development and
commercialization of its own products, the Reducer and the Tiara.
Sales of the Reducer for the three months ended June 30, 2017 were $247,555, compared to $246,122 for the same period in 2016,
representing an increase of 1%.
During the three months ended June 30,
2017 there was an overstocking of the Reducer at certain
distributors in Europe and as a
result quarterly purchases were not made by those
distributors. The Company is closely monitoring Reducer
revenue growth and may see some volatility on a quarterly basis due
to distributor purchase patterns. The Company continues to see
a significant increase in the underlying implant rate year over
year. 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.
Contract manufacturing revenues for the three months ended
June 30, 2017 were $152,717, compared to $240,837 for the same period in 2016,
representing a decrease of 37%. The decrease in revenue for the
three months ended March 31, 2017
compared to the same period in 2016 is primarily due to the loss of
Boston Scientific Corporation ("Boston Scientific") as a customer.
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 in exchange for 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. The Company believes that
going forward contract manufacturing revenues will be derived from
a smaller customer base as the transcatheter aortic valve market
matures.
Revenues from consulting services for the three months ended
June 30, 2017 were $904,864, compared to $1,223,973 for the same period in 2016,
representing a decrease of 26%. The loss 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
three months ended June 30, 2017 was
$872,703, compared to $1,391,708 for the same period in 2016. The
overall gross margin for the three months ended June 30, 2016 was 33%, compared to 19% gross
margin for the same period in 2016. The Company has seen its
gross margins increase due to a change in the product mix as
Reducer revenues reflect an increasing proportion of the overall
revenues.
Expenses
Total expenses for the three months ended
June 30, 2017 were $6,728,381, compared to $13,313,333 for the same period in 2016,
representing a decrease of $6,584,952
or 49%. The decrease in total expenses for the three months ended
June 30, 2017 compared to the same
period in 2016 reflects a $5,173,905
reduction in general and administrative expenses (of which
$5,184,935 relates to a decrease in
litigation expenses) and a $1,454,255
decrease in product development and clinical trial expenses to
advance the Tiara and the Reducer development programs.
Selling expenses for the three months ended June 30, 2017 were $224,382, compared to $181,174 for the same period in 2016,
representing an increase of $43,208,
or 24%. The increase in selling expenses for the three months ended
June 30, 2017 compared to the same
period in 2016 reflects an increase in costs incurred for
commercialization activities related to the Reducer. The Company
continues to minimize its selling expenses in the light of ongoing
litigation costs and the impact of litigation on the Company.
General and administrative expenses for the three months ended
June 30, 2017 were $2,253,219, compared to $7,427,124 for the same period in 2016,
representing a decrease of $5,173,905
or 70%. The decrease in general and administrative expenses for the
three months ended June 30, 2017
compared to the same period in 2016 can be substantially explained
by a $5,184,935 decrease in
litigation expenses.
Product development and clinical trial expenses for the three
months ended June 30, 2017 were
$4,250,780, compared to $5,705,035 for the same period in 2016,
representing a decrease of $1,454,255
or 25%. The decrease in product development and clinical trial
expenses for the three months ended June 30,
2017 was due to a $840,671
decrease in other expenses as the Company focused on clinical
activities and slowed product development activities to preserve
cash resources.
Other Income and Loss
The other income for the three
months ended June 30, 2017 was
$1,012,926, compared to a loss of
$70,648,431 for the same period in
2016, an increase in other income of $71,667,357. The increase in the other
income can be substantially explained by a $70 million decrease in the charge for the
damages provision related to the litigation with CardiAQ Valve
Technologies Inc. ("CardiAQ"). Included within other income
for the three months ended June 30,
2017 is a charge of $214,239
for post-judgment interest on the damages provision (see "Trends,
Risks and Uncertainties" and "Contractual Obligations and
Contingencies" in the Company's second quarter Management
Discussion and Analysis), (2016: $nil).
Losses
The operating losses and comprehensive losses
for the three months ended June 30,
2017 were $5,341,308 and
$6,097,512, respectively, or
$0.07 basic and diluted loss per
share, as compared with losses of $83,692,460 and $83,064,254, or $1.25 basic and diluted loss per share for the
same period in 2016. The $78,351,152
decrease in the operating loss incurred for the three months ended
June 30, 2017 compared to the same
period in 2016 consists of a $70
million damages provision related to the jury award against
the Company in its litigation with CardiAQ charged in the three
months ended June 30, 2016, a
$5,173,905 reduction in general and
administrative expenses (of which $5,184,935 relates to a decrease in litigation
expenses) and a $1,454,255 decrease
in product development and clinical trial expenses (as the Company
manages its cash resources). Litigation expenses for the three
months ended June 30, 2017 represent
a loss of $0.01 basic and diluted
loss per share compared to a loss of $0.09 basic and diluted loss per share for the
same period in 2016. The contingent liability for the three
months ended June 30, 2016 represent
a loss of $1.05 basic and diluted
loss per share. To date, the Company has incurred significant costs
in defending itself in lawsuits filed by CardiAQ. Total litigation
expenses since the initial claims were filed in June 2014 are approximately $22.5 million and the Company expects that it may
require an additional $0.5 million to
cover additional litigation expenses related to the U.S. appeal and
an additional $1.0 million related to
the ongoing appeal in Germany.
Discussion of Liquidity and Capital Resources
Neovasc
finances its operations and capital expenditures with cash
generated from operations and equity financings. As at
June 30, 2017 the Company had cash
and cash equivalents of $11,580,940
compared to cash and cash equivalents of $22,954,571 as at December
31, 2016. The Company's working capital deficit is
$29,777,487 as at June 30, 2017 compared to a working capital
deficit of $17,497,931 as at
December 31, 2016. Unless the Company
is successful in an appeal of the verdict in the litigation with
CardiAQ, or otherwise is successful in reducing the amount of the
approximate $112 million damages
award to an amount less than 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.
Cash used in operating activities for the three months ended
June 30, 2017, was $3,892,764, compared to $11,049,955 for the same period in 2016. For the
three months ended June 30, 2017,
operating expenses were $4,686,615,
compared to $12,870,083 for the same
period in 2016, a decrease of $8,183,468. This can substantially be
explained by a decrease in litigation expenses of $5,184,935.
Net cash applied to investing activities for the three months
ended June 30, 2017, was $229,265 compared to $225,951 in 2016. In 2017, the Company
invested in lease hold improvements for its new facility to replace
the facilities sold to Boston Scientific in 2016.
Net cash provided by financing activities for the three months
ended June 30, 2017, was $206,924, compared to $26,698 for the same period in 2016 from the
proceeds of options.
The majority of the revenue and expenses of the Company are
incurred in the parent and in one of its subsidiaries, Neovasc
Medical Inc., both of which are Canadian companies. There were
no significant restrictions on the transfer of funds between these
entities and during the three months ended June 30, 2017 and 2016 the Company had no
complications in transferring funds to and from its subsidiaries in
Israel and the United States.
The Company is exposed to foreign currency fluctuations on
$1,999,477 of its cash and cash
equivalents held in U.S. dollars and Euros.
Going Concern
The Company may be faced with
significant monetary damages in the litigation with CardiAQ 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 indicate the existence
of material uncertainty and cast substantial doubt about the
Company's ability to continue as a going concern.
Outstanding Share Data
As at August 10, 2017, the Company had 78,910,688
common voting shares issued and outstanding. Further, the
following securities are convertible into common shares of the
Company: 9,256,824 stock options with a weighted average price of
C$3.54. The fully diluted share
capital of the Company at August 10,
2017 is 88,167,512.
The Company prepares its consolidated financial statements in
accordance with International Financial Reporting Standards, as
issued by the International Accounting Standards Board.
Neovasc's second quarter 2017 financial statements and notes and
its Management's Discussion and Analysis will be posted on the
Company's website at www.neovasc.com and will be filed on
SEDAR and EDGAR. In addition to the summary contained herein,
readers are encouraged to review the full disclosure in Neovasc's
second quarter 2017 financial statements 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 773413#. 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.
Condensed Interim Consolidated Statements of Financial
Position (Expressed in U.S. dollars) (Unaudited)
|
|
|
|
|
|
|
June
30,
|
December
31,
|
|
|
2017
|
2016
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
11,580,940
|
$
|
22,954,571
|
|
|
Cash held in
escrow
|
|
70,190,184
|
70,000,000
|
|
|
Accounts
receivable
|
|
1,512,689
|
3,117,474
|
|
|
Inventory
|
|
424,742
|
196,723
|
|
|
Prepaid expenses and
other assets
|
|
919,800
|
505,340
|
|
Total current
assets
|
|
84,628,355
|
96,774,108
|
|
|
|
|
|
Non-current
assets
|
|
|
|
|
|
Restricted
cash
|
|
462,360
|
449,760
|
|
|
Property, plant and
equipment
|
|
1,787,762
|
1,585,635
|
|
Total non-current
assets
|
|
2,250,122
|
2,035,395
|
|
|
|
|
Total
assets
|
|
$
|
86,878,477
|
$
|
98,809,503
|
|
|
|
|
LIABILITIES AND
EQUITY
|
|
|
|
|
Liabilities
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
2,198,623
|
$
2,490,943
|
|
|
Damages
provision
|
|
112,207,219
|
111,781,096
|
|
Total current
liabilities and total liabilities
|
|
114,405,842
|
114,272,039
|
|
|
|
|
|
Equity
|
|
|
|
|
|
Share
capital
|
|
169,138,524
|
168,712,673
|
|
|
Contributed
surplus
|
|
23,835,573
|
22,301,437
|
|
|
Accumulated other
comprehensive loss
|
|
(5,531,561)
|
(4,693,040)
|
|
|
Deficit
|
|
(214,969,901)
|
(201,783,606)
|
|
Total
equity
|
|
(27,527,365)
|
(15,462,536)
|
|
|
|
|
Total liabilities
and equity
|
|
$
|
86,878,477
|
$
|
98,809,503
|
NEOVASC
INC. Condensed Interim Consolidated Statements of Loss
and Comprehensive Loss For the three and six months ended
June 30,
(Expressed in U.S. dollars) (Unaudited)
|
|
|
|
|
|
|
For the three months
ended
June 30,
|
For the six months
ended
June 30,
|
|
|
2017
|
2016
|
2017
|
2016
|
|
|
|
|
|
|
REVENUE
|
|
|
|
|
|
Reducer
|
|
$
|
247,555
|
$
|
246,122
|
$
|
508,320
|
$
|
459,887
|
Contract
manufacturing
|
|
152,717
|
240,837
|
286,680
|
847,620
|
Consulting
services
|
|
904,864
|
1,223,973
|
1,991,496
|
2,410,167
|
|
|
1,305,136
|
1,710,932
|
2,786,496
|
3,717,674
|
|
|
|
|
|
|
COST OF GOODS
SOLD
|
|
872,703
|
1,391,708
|
1,681,331
|
2,837,352
|
GROSS
PROFIT
|
|
432,433
|
319,224
|
1,105,165
|
880,322
|
|
|
|
|
|
|
EXPENSES
|
|
|
|
|
|
Selling
expenses
|
|
224,382
|
181,174
|
411,550
|
346,021
|
General and
administrative expenses
|
|
2,253,219
|
7,427,124
|
5,501,932
|
13,254,529
|
Product development
and clinical trials expenses
|
|
4,250,780
|
5,705,035
|
9,304,303
|
9,787,822
|
|
|
6,728,381
|
13,313,333
|
15,217,785
|
23,388,372
|
|
|
|
|
|
|
OPERATING
LOSS
|
|
(6,295,948)
|
(12,994,109)
|
(14,112,620)
|
(22,508,050)
|
|
|
|
|
|
|
OTHER
INCOME/(EXPENSE)
|
|
|
|
|
|
Interest
income
|
|
127,255
|
46,525
|
217,224
|
135,799
|
Interest on damages
provision
|
|
(214,239)
|
-
|
(426,123)
|
-
|
Damages
provision
|
|
-
|
(70,000,000)
|
-
|
(70,000,000)
|
Foreign exchange
gain
|
|
4,644,823
|
(694,956)
|
3,289,162
|
(2,103,253)
|
Unrealized loss on
damages provision
|
|
(3,544,913)
|
-
|
(2,039,038)
|
-
|
|
|
1,012,926
|
(70,648,431)
|
1,041,225
|
(71,967,454)
|
LOSS BEFORE
TAX
|
|
(5,283,022)
|
(83,642,540)
|
(13,071,395)
|
(94,475,504)
|
|
|
|
|
|
|
Tax
expense
|
|
(58,286)
|
(49,920)
|
(114,900)
|
(98,094)
|
|
|
|
|
|
|
LOSS FOR THE
PERIOD
|
|
$
|
(5,341,308)
|
$
|
(83,692,460)
|
$
|
(13,186,295)
|
$
|
(94,573,598)
|
|
|
|
|
|
|
OTHER
COMPREHENSIVE INCOME/(LOSS) FOR THE PERIOD
|
|
|
|
|
|
Exchange difference
on translation
|
|
2,788,709
|
628,206
|
1,200,517
|
3,917,642
|
Unrealized loss on
damages provision
|
|
(3,544,913)
|
-
|
(2,039,038)
|
-
|
|
|
(756,204)
|
628,206
|
(838,521)
|
3,917,642
|
|
|
|
|
|
|
LOSS AND
COMPREHENSIVE LOSS FOR THE
|
|
|
|
|
|
PERIOD
|
|
$
|
(6,097,512)
|
$
|
(83,064,254)
|
$
|
(14,024,816)
|
$
|
(90,655,956)
|
|
|
|
|
|
|
LOSS PER
SHARE
|
|
|
|
|
|
Basic and diluted
loss per share
|
|
$
|
(0.07)
|
$
|
(1.25)
|
$
|
(0.17)
|
$
|
(1.41)
|
NEOVASC
INC. Condensed Interim Consolidated Statements of Cash
Flows For the three and six months ended June 30,
(Expressed in U.S. dollars) (Unaudited)
|
|
|
|
|
|
|
For the three months
ended
|
For the six months
ended
|
|
|
June 30,
|
June 30,
|
|
|
2017
|
2016
|
2017
|
2016
|
|
|
|
|
|
|
OPERATING
ACTIVITIES
|
|
|
|
|
|
Loss for the
period
|
|
$
|
(5,341,308)
|
$
|
(83,692,460)
|
$
|
(13,186,295)
|
$
|
(94,573,598)
|
Adjustments
for:
|
|
|
|
|
|
|
Depreciation
|
|
134,445
|
199,497
|
245,728
|
346,980
|
|
Share-based
payments
|
|
373,843
|
669,405
|
1,735,520
|
1,230,989
|
|
Damages
provision
|
|
214,239
|
70,000,000
|
426,123
|
70,000,000
|
|
Write-down accounts
receivable
|
|
-
|
-
|
40,000
|
4,859
|
|
Income tax
expense
|
|
59,421
|
-
|
116,035
|
-
|
|
Interest
income
|
|
(127,255)
|
(46,525)
|
(217,224)
|
(135,799)
|
|
|
(4,686,615)
|
(12,870,083)
|
(10,840,113)
|
(23,126,569)
|
|
|
|
|
|
|
Net change in
non-cash working capital items:
|
|
|
|
|
|
|
Accounts
receivable
|
|
674,885
|
(130,686)
|
1,630,388
|
(173,935)
|
|
Inventory
|
|
46,571
|
(435,245)
|
(217,608)
|
(920,155)
|
|
Prepaid expenses and
other assets
|
|
37,912
|
9,687
|
(389,780)
|
(255,207)
|
|
Accounts payable and
accrued liabilities
|
|
135,521
|
2,321,390
|
(373,337)
|
2,385,879
|
|
|
894,889
|
1,765,146
|
649,663
|
1,036,582
|
|
|
|
|
|
|
Interest
received
|
|
13,862
|
54,982
|
103,831
|
136,320
|
Income tax
paid
|
|
(114,900)
|
-
|
(114,900)
|
-
|
|
|
(101,038)
|
54,982
|
(11,069)
|
136,320
|
|
|
|
|
|
|
Net cash applied
to operating activities
|
|
(3,892,764)
|
(11,049,955)
|
(10,201,519)
|
(21,953,667)
|
|
|
|
|
|
|
INVESTING
ACTIVITES
|
|
|
|
|
|
|
Increase in cash held
in escrow
|
|
(114,150)
|
-
|
(190,184)
|
-
|
|
Purchase of property,
plant and equipment
|
|
(115,115)
|
(225,951)
|
(390,341)
|
(531,536)
|
Net cash applied
to investing activities
|
|
(229,265)
|
(225,951)
|
(580,525)
|
(531,536)
|
|
|
|
|
|
|
FINANCING
ACTIVITIES
|
|
|
|
|
|
|
Proceeds from
exercise of options
|
|
206,925
|
26,698
|
224,467
|
75,192
|
Net cash received
from financing activities
|
|
206,925
|
26,698
|
224,467
|
75,192
|
|
|
|
|
|
|
NET CHANGE IN CASH
AND CASH EQUIVALENTS
|
|
(3,915,104)
|
(11,249,208)
|
(10,557,577)
|
(22,410,011)
|
|
|
|
|
|
|
CASH AND CASH
EQUIVALENTS
|
|
|
|
|
|
Beginning of the
period
|
|
16,206,632
|
46,903,192
|
22,954,571
|
55,026,171
|
Exchange difference
on cash and cash equivalents
|
|
(710,588)
|
623,809
|
(816,054)
|
3,661,633
|
End of the
period
|
|
$
11,580,940
|
$
36,277,793
|
$
11,580,940
|
$
36,277,793
|
|
|
|
|
|
|
Represented
by:
|
|
|
|
|
|
Cash
|
|
6,396,379
|
18,675,154
|
6,396,379
|
18,675,154
|
Cashable high
interest savings accounts
|
|
5,184,561
|
17,602,639
|
5,184,561
|
17,602,639
|
|
|
$
11,580,940
|
$
36,277,793
|
$
11,580,940
|
$
36,277,793
|
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 Company's intention to continue
the European CE Mark trial and schedule additional cases and add
additional sites in the coming months, the momentum of the
Company's regulatory and commercial teams, increases in the implant
rate of reducer, 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", "could", "may", "will", "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.