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
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August
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2016
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Commission File Number
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001-36458
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Neovasc Inc.
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(Translation of registrant’s name into English)
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Suite 5138
– 13562 Maycrest Way
Richmond,
British Columbia, Canada V6V 2J7
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(Address of principal executive offices)
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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 – Neovasc Reports Second Quarter Results for 2016
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This
Report on Form 6-K is incorporated by reference into the Registration Statement on Form F-10 of the Registrant, which was originally
filed with the Securities and Exchange Commission on April 17, 2014 (File No. 333-195360), and the Registration Statement on Form
S-8 of the Registrant, which was originally filed with the Securities and Exchange Commission on June 24, 2014 (File No. 333-196986).
Document 1
Neovasc Reports Second Quarter Results for 2016
NASDAQ: NVCN
TSX: NVC
VANCOUVER, Aug. 9, 2016 /CNW/ - Neovasc Inc. ("
Neovasc
"
or the "
Company
") (NASDAQ: NVCN) (TSX: NVC) today announced financial results for the quarter ended June 30, 2016
(all figures in US dollars unless otherwise indicated).
"Activities to increase the rate of enrolment of patients
in the Tiara clinical program, including adding new centres, introducing the 40 mm Tiara and refining inclusion criteria are resulting
in an increased number of implantations. There have now been 19 patients treated with Tiara and we continue to be encouraged
by the early results from these cases," commented Neovasc CEO, Alexei Marko. "In addition, the commercial launch of Reducer
in select European countries and elsewhere continues to build momentum, with the second quarter being our sixth consecutive quarter
of strong sales growth."
Litigation Update
On June 6, 2014, Neovasc was named in a lawsuit filed by CardiAQ
Valve Technologies, Inc. ("CardiAQ") in the U.S. District Court for the District of Massachusetts concerning intellectual
property rights ownership, alleged unfair trade practices and an alleged breach of contract relating to Neovasc's transcatheter
mitral valve technology, including Tiara.
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·
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On May 19, 2016, following a trial in Boston, a jury
found in favor of CardiAQ, on CardiAQ's claims for relief for breach of contract, breach of the duty of honesty in contractual
performance, and three of CardiAQ's six asserted trade secrets.
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·
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The jury awarded US$70 million on the trade secret
claim for relief, and no damages on the contractual claims for relief.
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·
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Both parties are pursuing a number of post-trial motions,
including a motion from CardiAQ seeking an injunction to require the Company to cease Tiara operations for 18 months, and all related
briefs for those motions are to be filed by August 12. The Court is then expected to hold a hearing on these motions and
issue an order sometime in the near future. Following the court order, one or both parties may potentially pursue appeals
before the U.S. Court of Appeals for the Federal Circuit.
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·
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The Company has provided for a $70 million contingent
liability in its financial statements as at June 30, 2016.
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·
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Additional information regarding the CardiAQ litigation
can be found in Managements Discussion and Analysis of Financial Condition and Results of Operations for the three and six months
ended June 30, 2016 and 2015.
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·
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The Company intends to vigorously defend itself in
the litigation with CardiAQ and so the outcome of these matters, including whether the Company will be required to pay some or
all of the jury award of $70 million, is not currently determinable.
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·
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Litigation is inherently uncertain. Therefore,
until these matters have been resolved to their ultimate conclusion by the appropriate courts, the Company cannot give any assurances
as to the outcome. If the Company is unsuccessful in its defense of these claims, including any appeal of the verdict in
the Massachusetts litigation, or is unable to settle the claims in a manner satisfactory to the Company, it may be faced with significant
monetary damages that could exceed its resources, the loss of intellectual property rights and damage to its competitive position.
|
Separate to the litigation with CardiAQ, on June 6, 2016,
an alleged purchaser of Neovasc common stock filed a lawsuit, on behalf of a putative class of purchasers of Neovasc securities,
against Neovasc in the United States District Court for the District of Massachusetts concerning alleged violations of the United
States securities laws. The complaint filed in the lawsuit, which principally bases the plaintiff's claims on the Company's prior
disclosures regarding the lawsuit filed by CardiAQ in the United States District Court for the District of Massachusetts, does
not specify the amount of damages sought. Further, as of the present time, no class has been certified by the court.
The Company and its officers have filed a motion to dismiss the complaint and intend to vigorously defend themselves in the litigation,
and so the outcome of this matter is not currently determinable. Litigation is inherently uncertain. Therefore, until
this matter has been resolved to its ultimate conclusion by the appropriate court, the Company cannot give any assurances as to
the outcome.
Going Concern
The circumstances relating to the CardiAQ litigation described
above indicate the existence of material uncertainty and cast substantial doubt about the Company's ability to continue as a going
concern.
Results for the three months ended June 30, 2016 and 2015
Revenues
Revenues for the three months ended June 30, 2016 were $1,710,932 compared to revenues of $2,972,382 for the same period in 2015,
representing a decrease of 42%. The Company is focusing its business away from its traditional revenue streams towards development
and commercialization of its own products, the Reducer and the Tiara. 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.
Sales of the Reducer for the three months ended June 30, 2016
were $246,122, compared to $134,607 for the same period in 2015, representing an increase of 83%. The Reducer has seen steady
quarter over quarter revenue growth since in launch in the first quarter of 2015. The 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.
Revenues from consulting services for the three months ended
June 30, 2016 were $1,223,973, compared to $1,700,464 for the same period in 2015, representing a decrease of 28%. 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 being customers as they move manufacturing in house. Contract manufacturing
revenues for the three months ended June 30, 2016 were $240,837, compared to $972,216 for the same period in 2015, representing
a decrease of 75%. The decrease in revenue for the three months ended June 30, 2016 compared to the same period in 2015 is
primarily due to temporary delay in shipping to a single customer that resulted in an increase in inventory during the period.
The delay in shipping has been resolved and the Company believes it will clear the backlog and return sales to more appropriate
levels in the third quarter and beyond.
Cost of Goods Sold
The cost of goods sold for the three months ended June 30, 2016 was $1,391,708, compared to $1,815,354 for the same period in 2015.
The overall gross margin for the three months ended June 30, 2016 was 19%, compared to 38% gross margin for the same period in
2015. The decrease in the margins can be attributed to a significant decrease in throughput during the quarter as sales to
a single large customer were stalled. The Company has seen its consulting services revenue margins decline as its ability
to charge higher fees for these services has decreased as the transcatheter aortic valve market has matured. In addition,
the Company is experiencing higher cost of goods sold as it has implemented a rigorous commercial stage quality system required
to meet the expectations of its more advanced customers. These increases are not productive improvements and result in an
overall downward trend in margins.
Expenses
Total expenses for the three months ended June 30, 2016 were $13,313,333, compared to $7,940,815 for the same period in 2015, representing
an increase of $5,372,518 or 68%. The increase in total expenses for the three months ended June 30, 2016 compared to the
same period in 2015 reflects a $55,696 increase in sales and marketing expenses as the Company expands its commercialization activities
of the Reducer in Europe, a $3,892,082 increase in general and administrative expenses (of which $4,017,810 relates to an increase
in litigation expenses) and a $1,424,740 increase 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, 2016
were $181,174, compared to $125,478 for the same period in 2015, representing an increase of $55,696, or 44%. The increase
in selling expenses for the three months ended June 30, 2016 compared to the same period in 2015 reflects an increase in costs
incurred for commercialization activities related to the Reducer. The Company expects to continue to increase its selling
expenses in 2016 as it continues its commercialization of the Reducer in select countries in Europe.
General and administrative expenses for the three months ended
June 30, 2016 were $7,427,124, compared to $3,535,042 for the same period in 2015, representing an increase of $3,892,082 or 110%.
The increase in general and administrative expenses for the three months ended June 30, 2016 compared to the same period in 2015
can be substantially explained by a $4,017,810 increase in litigation expenses and a decrease of $125,728 in all other expenses.
Product development and clinical trial expenses for the three
months ended June 30, 2016 were $5,705,035, compared to $4,280,295 for the same period in 2015, representing an increase of $1,424,740,
or 33%. The increase in product development and clinical trial expenses for the three months ended June 30, 2016 was due
to a $295,159 increase in cash-based employee expenses as the Company hired additional staff to advance product development and
a $1,501,447 increase in other expenses as the Company invested in its two major new product initiatives, offset by a $421,204
decrease in share-based payments.
Other Loss
The other loss for the three months ended June 30, 2016 was $70,648,431, compared to other income of $76,447 for the same period
in 2015. As at June 30, 2016 the Company has recognized a contingent liability of $70 million after a jury award on certain
trade secret claims made by CardiAQ as described above. In addition, during the three months ended June 30, 2016 the Company
had an increase in foreign exchange losses of $553,645 and a decrease in interest income of $172,471 compared to the same period
in 2015.
Losses
The operating losses and comprehensive losses for the three months ended June 30, 2016 were $83,692,460 and $83,064,254, respectively,
or $1.25 basic and diluted loss per share, as compared with losses of $6,752,338 and $5,295,022, or $0.10 basic and diluted loss
per share for the same period in 2015. The $76,940,122 increase in the operating loss incurred for the three months ended
June 30, 2016 compared to the same period in 2015 consists of a $70 million contingent liability related to the jury award against
the Company in its litigation with CardiAQ, a $792,806 reduction in gross margin, a $3,892,082 increase in general and administrative
expenses (of which $4,017,810 relates to an increase in litigation expenses), a $1,424,740 increase in product development and
clinical trial expenses, and a $553,645 increase in foreign exchange losses.
The contingent liability for the three months ended June 30,
2016 represent a loss of $1.05 basic and diluted loss per share compared to a loss of $nil basic and diluted loss per share for
the same period in 2015. Litigation expenses for the three months ended June 30, 2016 represent a loss of $0.09 basic and
diluted loss per share compared to a loss of $0.03 basic and diluted loss per share for the same period in 2015. 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 $17.7 million and the Company expects that it may require an additional
$5.0 million to cover additional litigation expenses up to and including appellate court, if applicable.
Discussion of Liquidity And Capital Resources
Neovasc finances its operations and capital expenditures with cash generated from operations, lines of credit and equity financings.
As at June 30, 2016 the Company had cash and cash equivalents of $36,277,793 compared to cash and cash equivalents of $55,026,171
as at December 31, 2015.
Cash used in operating activities for the three months ended
June 30, 2016 was $11,049,955, compared to $5,196,762 for the same period in 2015. Cash expenditures on litigation (litigation
expenses less change in accounts payable related to litigation) were $4,494,560 and within accounts payable there was $2,965,629
of litigation expenses incurred but not paid for in connection with the litigation with CardiAQ that will be paid in the following
quarter. Cash expenditures on research and development and clinical trials (expenses less share based payments and depreciation)
were $5,225,895 as the Company furthered the development of the Tiara and the Reducer and cash expenditures on general and administrative
expenses were $1,363,620. The increase in expenditures between the three months ended June 30, 2016 and the same period in
2015 can be explained by a $2,719,099 increase in expenditures in connection with the litigation with CardiAQ, a $1,796,606 increase
in expenditures on research and development and clinical trials as we accelerate our development and clinical programs for the
Tiara and the Reducer and a $849,597 reduction in contribution from gross margin as our revenue and margins declined.
The Company's working capital, excluding the $70 million contingent
liability in connection with the litigation with CardiAQ, is $34,494,085 as at June 30, 2016 compared to $54,274,867 as at December
31, 2015. Unless the Company is successful in post-trial motions and/or an appeal of the verdict, or otherwise is successful
in reducing the amount of the $70 million award, 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.
Outstanding Share Data
As at August 9, 2016, the Company had 66,866,345 common voting shares issued and outstanding. Further, the following
securities are convertible into common shares of the Company: 8,133,999 stock options with a weighted average price of C$3.96.
The fully diluted share capital of the Company at August 9, 2016 is 75,000,344.
All financial information is prepared in accordance with International
Financial Reporting Standards, as issued by the International Accounting Standards Board, and is expressed in U.S. dollars.
Neovasc's unaudited condensed interim consolidated financial
statements and notes thereto for the three and six months ended June 30, 2016 and 2015 as well as Management's Discussion and Analysis
of Financial Condition and Results of Operations will be posted on the Company's website at www.neovasc.com and will be filed on
SEDAR at www.sedar.com and EDGAR at www.sec.gov. In addition to the summary contained herein, readers are encouraged to review
the unaudited condensed interim consolidated financial statements and notes thereto for the three and six months ended June 30,
2016 and 2015 as well as the related Management's Discussion and Analysis of Financial Condition and Results of Operations.
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 0605 or 416 764 8609. A recording of the call will be available for 72 hours by calling 888 390 0541 or 416
764 8677 and using passcode 991845#. 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)
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June 30,
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December 31,
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2016
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2015
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ASSETS
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Current assets
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Cash and cash equivalents
|
$
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36,277,793
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$
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55,026,171
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Accounts receivable
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2,017,973
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1,736,941
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Inventory
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1,579,357
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598,136
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Prepaid expenses and other assets
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425,997
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146,590
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Total current assets
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40,301,120
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57,507,838
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Non-current assets
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Property, plant and equipment
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4,151,563
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3,720,556
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Total non-current assets
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4,151,563
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3,720,556
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Total assets
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$
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44,452,683
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$
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61,228,394
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LIABILITIES AND EQUITY
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Liabilities
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Current liabilities
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Accounts payable and accrued liabilities
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$
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5,807,035
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$
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3,232,971
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Contingent liability for damages
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70,000,000
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-
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Total current liabilities and total liabilities
|
75,807,035
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3,232,971
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Equity
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Share capital
|
161,658,013
|
161,505,037
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|
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Contributed surplus
|
21,722,315
|
20,569,110
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|
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Accumulated other comprehensive loss
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(4,872,369)
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(8,790,011)
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|
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Deficit
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(209,862,311)
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(115,288,713)
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Total equity
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(31,354,352)
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57,995,423
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|
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Total liabilities and equity
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$
|
44,452,683
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$
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61,228,394
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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)
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Three months ended
June 30,
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Six months ended
June 30,
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2016
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2015
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2016
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2015
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REVENUE
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Reducer
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$
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246,122
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$
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134,607
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$
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459,887
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$
|
175,005
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Product sales
|
-
|
120,097
|
-
|
343,508
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Contract manufacturing
|
240,837
|
972,216
|
847,620
|
1,535,778
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Consulting services
|
1,223,973
|
1,700,464
|
2,410,167
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3,177,916
|
|
1,710,932
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2,927,384
|
3,717,674
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5,232,207
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|
|
|
|
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COST OF GOODS SOLD
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1,391,708
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1,815,354
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2,837,352
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3,422,926
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GROSS PROFIT
|
319,224
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1,112,030
|
880,322
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1,809,281
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EXPENSES
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|
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Selling expenses
|
181,174
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125,478
|
346,021
|
249,300
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General and administrative expenses
|
7,427,124
|
3,535,042
|
13,254,529
|
5,861,428
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Product development and clinical trials expenses
|
5,705,035
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4,280,295
|
9,787,822
|
7,711,688
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|
13,313,333
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7,940,815
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23,388,372
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13,822,416
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|
|
|
|
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OPERATING LOSS
|
(12,994,109)
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(6,828,785)
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(22,508,050)
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(12,013,135)
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|
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OTHER (EXPENSE)/INCOME
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|
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Interest income
|
46,525
|
218,996
|
135,799
|
318,431
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Interest expense
|
-
|
(1,238)
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-
|
(2,538)
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Contingent liability for damages
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(70,000,000)
|
-
|
(70,000,000)
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-
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Loss on foreign exchange
|
(694,956)
|
(141,311)
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(2,103,253)
|
(16,470)
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|
(70,648,431)
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76,447
|
(71,967,454)
|
299,423
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LOSS BEFORE TAX
|
(83,642,540)
|
(6,752,338)
|
(94,475,504)
|
(11,713,712)
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|
|
|
|
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Tax expense
|
(49,920)
|
-
|
(98,094)
|
-
|
|
|
|
|
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LOSS FOR THE PERIOD
|
$
|
(83,692,460)
|
$
|
(6,752,338)
|
$
|
(94,573,598)
|
$
|
(11,713,712)
|
|
|
|
|
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OTHER COMPREHENSIVE INCOME/(EXPENSE) FOR
THE PERIOD
|
|
|
|
|
Exchange difference on translation
|
628,206
|
1,457,316
|
3,917,642
|
(1,258,364)
|
|
|
|
|
|
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD
|
$
|
(83,064,254)
|
$
|
(5,295,022)
|
$
|
(90,655,956)
|
$
|
(12,972,076)
|
|
|
|
|
|
LOSS PER SHARE
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|
|
|
|
Basic and diluted loss per share
|
$
|
(1.25)
|
$
|
(0.10)
|
$
|
(1.41)
|
$
|
(0.18)
|
NEOVASC INC.
Condensed Interim Consolidated Statements of Cash Flows
For the three and six months ended June 30,
(Expressed in U.S. dollars) (Unaudited)
|
|
|
|
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|
2016
|
2015
|
2016
|
2015
|
|
|
|
|
|
OPERATING ACTIVITIES
|
|
|
|
|
Loss for the period
|
$
|
(83,692,460)
|
$
|
(6,752,338)
|
$
|
(94,573,598)
|
$
|
(11,713,712)
|
Adjustments for:
|
|
|
|
|
|
Depreciation
|
199,497
|
107,098
|
346,980
|
204,327
|
|
Share-based payments
|
669,405
|
1,125,580
|
1,230,989
|
2,320,394
|
|
Contingent liability for damages
|
70,000,000
|
-
|
70,000,000
|
-
|
|
Accounts receivable write down
|
-
|
-
|
4,859
|
-
|
|
Interest income
|
(46,525)
|
(251,483)
|
(135,799)
|
(350,918)
|
|
Interest expense
|
-
|
1,238
|
-
|
2,538
|
|
(12,870,083)
|
(5,769,905)
|
(23,126,569)
|
(9,537,371)
|
|
|
|
|
|
Net change in non-cash working capital items:
|
|
|
|
|
|
Accounts receivable
|
(130,686)
|
168,992
|
(173,935)
|
193,109
|
|
Inventory
|
(435,245)
|
19,654
|
(920,155)
|
(20,770)
|
|
Prepaid expenses and other assets
|
9,687
|
(96,087)
|
(255,207)
|
(184,264)
|
|
Accounts payable and accrued liabilities
|
2,321,390
|
301,074
|
2,385,879
|
674,840
|
|
1,765,146
|
393,633
|
1,036,582
|
662,915
|
|
|
|
|
|
Interest paid and received:
|
|
|
|
|
|
Interest received
|
54,982
|
180,748
|
136,320
|
221,898
|
|
Interest paid
|
-
|
(1,238)
|
-
|
(2,538)
|
|
54,982
|
179,510
|
136,320
|
219,360
|
|
|
|
|
|
Net cash applied to operating activities
|
(11,049,955)
|
(5,196,762)
|
(21,953,667)
|
(8,655,096)
|
|
|
|
|
|
INVESTING ACTIVITIES
|
|
|
|
|
|
(Investment in)/redemption of guaranteed investment
certificates
|
-
|
(892,663)
|
-
|
3,135,836
|
|
Purchase of property, plant and equipment
|
(225,951)
|
(872,230)
|
(531,536)
|
(1,267,134)
|
Net cash (applied to)/received from investing
activities
|
(225,951)
|
(1,764,893)
|
(531,536)
|
1,868,702
|
|
|
|
|
|
FINANCING ACTIVITIES
|
|
|
|
|
|
Repayment of long-term debt
|
-
|
(155,766)
|
-
|
(164,364)
|
|
Proceeds from share issue pursuant to an underwritten
public offering, net of share issue costs
|
-
|
-
|
-
|
69,879,210
|
|
Proceeds from exercise of options
|
26,698
|
17,329
|
75,192
|
906,541
|
Net cash received from/(applied to) financing
activities
|
26,698
|
(138,437)
|
75,192
|
70,621,387
|
|
|
|
|
|
NET CHANGE IN CASH AND CASH EQUIVALENTS
|
(11,249,208)
|
(7,100,092)
|
(22,410,011)
|
63,834,993
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS
|
|
|
|
|
Beginning of the period
|
46,903,192
|
74,423,335
|
55,026,171
|
5,193,561
|
Exchange difference on cash and cash equivalents
|
623,809
|
1,346,302
|
3,661,633
|
(359,009)
|
End of the period
|
$
|
36,277,793
|
$
|
68,669,545
|
$
|
36,277,793
|
$
|
68,669,545
|
|
|
|
|
|
Represented by:
|
|
|
|
|
Cash
|
18,675,154
|
2,159,083
|
18,675,154
|
2,159,083
|
Cashable high interest savings accounts
|
17,602,639
|
18,070,708
|
17,602,639
|
18,070,708
|
Cashable guaranteed investment certificates
|
-
|
48,439,754
|
-
|
48,439,754
|
|
$
|
36,277,793
|
$
|
68,669,545
|
$
|
36,277,793
|
$
|
68,669,545
|
About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular
marketplace. Its products in development include the Tiara™, for the transcatheter treatment of mitral valve disease
and the Neovasc Reducer™ for the treatment of refractory angina. 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 plans, intentions and expectations relating to the CardiAQ litigation and other litigation, its ability to continue as
a going concern, its expectations regarding the commercial launch of Reducer, its intention to focus business away from its traditional
revenue streams towards development and commercialization of its own products, its expectation that its consulting services revenue
will decline in the long term, its expectations with respect to the backlog described above, its expectations with respect to margins
and selling expenses, and other matters. The words "expect", "anticipate", "may", "will",
"intend", "believe", "continue", "focusing", "trend", 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 related to the Company's litigation with CardiAQ,
which create material uncertainty and cast substantial doubt on its ability to continue as a going concern; the conduct or possible
outcomes of any actual or threatened legal proceedings, which are inherently uncertain, and which could direct its resources and
result in the payment of significant damages and other penalties; its ability to defend CardiAQ's motion for an injunction to require
the Company to cease Tiara operations for 18 months; its ability to raise additional funding; the potential benefits of the
Neovasc Reducer™ and Tiara™ as compared with other products; successful enrollment of patients in studies and trials
for the Neovasc Reducer™ and Tiara™; results of the trials and studies for the Neovasc Reducer™ and Tiara™
that meet the Company's expectations; the Company's receipt of any required local and institutional regulatory approvals and the
timing and costs of obtaining such approvals; European enrollment in our clinical trials, studies and compassionate use cases and
the success of applications in Europe; the Company's ability to protect its intellectual property; the Company's ability to raise
additional funding; changes in business strategy or development plans; existing governmental regulations and changes in, or the
failure to comply with, governmental regulations and general economic and business conditions, both nationally and in the regions
in which the Company operates. 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 Operation (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.
%CIK: 0001399708
For further information:
Investor Relations, Neovasc Inc.,
Chris Clark, 604 248-4138, cclark@neovasc.com
CO: Neovasc Inc.
CNW 16:00e 09-AUG-16
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:
August 9,
2016
|
By:
|
/s/
Chris Clark
|
|
Name:
|
Chris Clark
|
|
Title:
|
Chief Financial Officer
|
Neovasc (NASDAQ:NVCN)
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