UNITED STATES
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 November 2020

Commission File Number: 001-36458

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.

[ x ] Form 20-F   [  ] 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): [   ]


SUBMITTED HEREWITH

Exhibits

Exhibit Description
  
99.1   News Release dated November 5, 2020

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: November 5, 2020 By /s/ Chris Clark
    Chris Clark
    Chief Financial Officer


Neovasc Inc.: Exhibit 99.1 - Filed by newsfilecorp.com

NASDAQ, TSX: NVCN

Neovasc Announces Third Quarter Financial Results

VANCOUVER and MINNEAPOLIS, November 5, 2020 - Neovasc, Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina, today reported financial results for the third quarter ended September 30, 2020.

Third Quarter Highlights

"Neovasc continued to execute on its value creation strategies during the third quarter.  We, like other device makers, had to contend with restrictions on elective procedures caused by the COVID-19 pandemic but we are nonetheless pleased with our progress during the quarter," said Fred Colen, President and Chief Executive Officer of Neovasc. "On the commercial front, Reducer implants experienced a sharp increase during the quarter of 50%, including 100% volume growth in the DACH region, which includes Germany, a core market for this novel device. We expect a negative impact on Reducer revenue generation during the fourth quarter, due to recent severe COVID-19 virus flare ups and lockdowns in much of Europe. On Tiara, during the Quarter, we also continued to advance our regulatory submission for Tiara TA in Europe and made further progress in the development of the Tiara TF. Financially, we continued to shore up our balance sheet, retiring some of our convertible debt and raising $12.6 million in a registered direct offering. We look forward to building on our progress and optimizing the value of our two unique devices, Reducer and Tiara."

Subsequent Events

On October 27, 2020, the Company announced that the United States Food and Drug Administration's (FDA's) Circulatory System Devices Advisory Panel voted 14 to 4 "in favor" that the Neovasc Reducer™ is safe when used as intended, and voted 1 to 17 "against" on the issue of a reasonable assurance of effectiveness. The third vote was 13 to 3 "against" (2 abstained) on whether the relative benefits outweighed the relative risks.


"While we are obviously disappointed in the outcome from the panel, going into the panel meeting, we anticipated that the totality of data would be seriously considered by the panel, particularly considering the context of the number of FDA guidance documents and the limited treatment options for the refractory angina patient population. We must await the FDA's decision on the PMA, and we are not hopeful about approval of the Reducer at this point given the panel's recommendation," commented Fred Colen.

Financial results for the third quarter ended September 30, 2020

Revenues increased by 25% to $626,418 for the three months ended September 30, 2020, compared to revenues of $500,498 for the same period in 2019. The cost of goods sold for the three months ended September 30, 2020 was $150,503 compared to $137,999 for the same period in 2019. The overall gross margin for the three months ended September 30, 2020 was 76%, compared to 72% gross margin for the same period in 2019.

Total expenses for the three months ended September 30, 2020 were $10,644,367 compared to $7,355,531 for 2019, representing an increase of $3,288,836 or 45%, principally as a result of a $1,966,695 increase in legal fees related to financings and a $618,948 increase in non-cash share-based payments as incentives were issued to all staff. The operating losses and comprehensive losses for the three months ended September 30, 2020 were $10,168,452 and $10,392,921, respectively, or $0.51 basic and diluted loss per share, as compared with $6,993,032 operating losses and  $6,555,186 comprehensive loss, or $0.83 basic and diluted loss per share, for the same period in 2019.

Conference Call and Webcast information

Neovasc will be hosting a conference call and audio webcast today at 4:30 pm ET to discuss these results.

Domestic: 1-800-430-8332

International: 1-856-344-9206

Parties wishing to access the call via webcast should use the link in the Investors section of the Neovasc website at https://www.neovasc.com/investors/

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 Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com.


Investors

Mike Cavanaugh

Westwicke/ICR

Phone: +1.646.877.9641

Mike.Cavanaugh@westwicke.com

Media

Sean Leous

Westwicke/ICR

Phone: +1.646.677.1839

Sean.Leous@icrinc.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact.  When used herein, the words "expect", "anticipate", "estimate", "may", "will", "should", "intend," "believe", and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the expected impact on Reducer revenue generation during the fourth quarter, the Company's ability to build on progress and optimizing the value of its devices, the likelihood of approval under the FDA's decision on the PMA, the expansion of its product range, prospects for regulatory approvals and the growing cardiovascular marketplace. 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 could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described in the "Risk Factors" section of the Company's Annual Report on Form 20-F and in the Management's Discussion and Analysis for the three and nine months ended September 30, 2020 (copies of which 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.




NEOVASC INC.

Condensed Interim Consolidated Statements of Financial Position

(Expressed in U.S. dollars) (Unaudited) 

 

September 30,

December 31,

 

2020

2019

 

 

 

 

ASSETS

 

 

 

  Current assets

 

 

 

    Cash and cash equivalents

 

$    14,034,457

$            5,292,833

    Accounts receivable

 

870,114

715,696

    Finance lease receivable

 

93,492

86,764

    Inventory

 

713,431

618,650

    Research and development supplies

 

337,092

671,845

    Prepaid expenses and other assets

 

611,791

630,042

  Total current assets

 

16,660,377

8,015,830

 

 

 

 

Non-current assets

 

 

 

    Restricted cash

 

450,331

462,874

    Right-of-use asset

 

753,357

720,473

    Finance lease receivable 

 

67,706

138,690

    Property and equipment

 

854,291

767,973

  Total non-current assets

 

2,125,685

2,090,010

 

 

 

 

Total assets

 

$      18,786,062

$          10,105,840

 

 

 

 

LIABILITIES AND EQUITY

 

 

 

  Liabilities

 

 

 

  Current liabilities

 

 

 

  Accounts payable and accrued liabilities

 

$        6,997,723

$            7,794,456

  Lease liabilities

 

323,570

436,352

  2017 Convertible notes

 

-

5,400,189

  2019 Convertible notes

 

167,409

1,090,561

  2020 Convertible notes

 

134,697

-

  Total current liabilities

 

7,623,399

14,721,558

 

 

 

 

  Non-Current Liabilities

 

 

 

  Accounts payable and accrued liabilities

 

-

1,186,601

    Lease liabilities

 

550,162

468,527

    2019 Convertible notes

 

5,790,155

8,174,919

    2020 Convertible notes

 

2,662,029

-

    Derivative liability - warrants

 

1,507,467

-

Total non-current liabilities

 

10,509,813

9,830,047

 

 

 

 

Total liabilities

 

$      18,133,212

$          24,551,605

 

 

 

 

  Equity

 

 

 

    Share capital

 

$    365,267,373

$        328,460,681

    Contributed surplus

 

33,358,931

29,766,225

    Accumulated other comprehensive loss

 

(7,169,707)

(6,140,507)

    Deficit

 

(390,803,747)

(366,532,164)

  Total equity

 

652,850

(14,445,765)

 

 

 

 

Total liabilities and equity

 

$      18,786,062

$          10,105,840





NEOVASC INC.

Condensed Interim Consolidated Statements of Loss and Comprehensive Loss

For the three and nine months ended September 30,

(Expressed in U.S. dollars) (Unaudited) 

 

 

For the three months ended

For the nine months ended

 

 

September 30

September 30

 

 

2020

2019

2020

2019

REVENUE

 

$          626,418

$          500,498

$        1,443,360

$      1,526,211

COST OF GOODS SOLD

 

150,503

137,999

349,735

348,987

GROSS PROFIT

 

475,915

362,499

1,093,625

1,177,224

 

 

 

 

 

 

EXPENSES

 

 

 

 

 

Selling expenses

 

498,671

380,412

1,504,714

1,143,157

General and administrative expenses

 

4,642,979

2,197,922

10,955,991

7,342,314

Product development and clinical trials expenses

 

5,502,717

4,777,197

14,615,847

13,165,344

 

 

10,644,367

7,355,531

27,076,552

21,650,815

 

 

 

 

 

 

OPERATING LOSS

 

(10,168,452)

(6,993,032)

(25,982,927)

(20,473,591)

 

 

 

 

 

 

OTHER (EXPENSE)/INCOME

 

 

 

 

 

Interest and other income

 

495,628

58,651

554,278

78,040

Interest and prepayment penalty expense

 

(191,989)

-

(729,539)

-

Impairment on right-of-use asset

 

-

-

-

(260,616)

Gain/(loss) on foreign exchange

 

(65,983)

(16,111)

(191,636)

(28,262)     

Unrealized gain/(loss) on derivative liability

 

 

 

 

 

  warrants and convertible notes

 

730,242

934,129

4,233,073

(1,166,922)

Realized gain/(loss) on exercise of warrants,

 

 

 

 

 

  derivative liability warrants and convertible notes

 

1,567,127

(201,119)

587,497

(938,374)

Amortization of deferred loss

 

(2,601,250)

-

(2,736,332)

-

 

 

(66,225)

775,550

1,717,341

(2,316,134)

LOSS BEFORE TAX

 

(10,234,677)

(6,217,482)

(24,265,586)

(22,789,725)

 

 

 

 

 

 

Tax (expense)/recovery

 

-

15,505

(5,997)

12,895

LOSS FOR THE PERIOD

 

$    (10,234,677)

$      (6,201,977)

$    (24,271,583)

$  (22,776,830)

 

 

 

 

 

 

OTHER COMPREHENSIVE (LOSS)/INCOME FOR THE PERIOD

 

 

 

 

 

Fair market value changes in convertible notes due to changes in own credit risk

 

(158,244)

(353,209)

(1,029,200)

312,973

LOSS AND OTHER COMPREHENSIVE LOSS FOR THE PERIOD

 

$   (10,392,921)

$      (6,555,186)

$    (25,300,783)

$  (22,463,857)

 

 

 

 

 

 

LOSS PER SHARE

 

 

 

 

 

Basic and diluted loss per share

 

$              (0.51)

$              (0.83)

$              (1.69)

$            (3.72)