UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2017March 31, 2020

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________ to ________

 

Commission File Number 333-198073 001-36747

Second Sight Medical Products, Inc.

(Exact name of Registrant as specified in its charter)

 

California

02-0692322

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer Identification No.)

 

12744 San Fernando Road, Suite 400, Sylmar, CA 91342

(Address of principal executive offices, including zip code)

 

(818) 833-5000

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock

EYES

NASDAQ

Warrants

EYESW

NASDAQ

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes    No 

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§229.405232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer,” and “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer

Accelerated filer

Non-accelerated filer   ☐

 (Do not check if a smaller reporting company)

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).     

Yes    No 

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.     Yes      No  

 

As of November 3, 2017,June 25, 2020, the issuerregistrant had 56,806,35223,118,233 shares of common stock, issuedno par value per share and 7,682,244 warrants, outstanding.

 


EXPLANATORY NOTE

As previously disclosed in the Current Report on Form 8-K filed by Second Sight Medical Products, Inc. (the “Company”) with the Securities and Exchange Commission (the “SEC”) on May 12, 2020, the filing of this Quarterly Report on Form 10-Q for the period ended March 31, 2020 (this “Form 10-Q”) was delayed due to circumstances related to the ongoing COVID-19 global pandemic. In compliance with local governmental “shelter in place” measures and to limit the risk of exposure to and transmission of the SARS-CoV-2 virus, which causes COVID-19, access to the Company’s facilities has been restricted and the Company’s employees have a minimal presence in its offices for essential activities. These restrictions caused limited access to the Company’s facilities and disrupted normal interactions among the Company’s accounting personnel and other staff, all of which slowed the completion of the Company’s quarterly review and preparation of the Form 10-Q. Accordingly, the Company’s ability to complete its quarterly review and to prepare and file the Form 10-Q by the original SEC filing deadline had been hampered. As a result, the Company relied on the “Order under Section 36 of the Securities Exchange Act of 1934 Modifying Exemptions From the Reporting and Proxy Delivery Requirements for Public Companies” dated March 25, 2020 (Release No. 34-88465) issued by the SEC to delay the filing of this Form 10-Q.

 


SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

 

FormFORM 10-Q for the Quarter Ended September 30, 2017

INDEXTABLE OF CONTENTS 

 

PART I

FINANCIAL INFORMATION

Item 1.

Financial Statements

Condensed Consolidated Balance Sheets as of September 30, 2017 (Unaudited)March 31, 2020 (unaudited) and December 31, 20162019

34

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2017March 31, 2020 and 2016 (Unaudited)2019 (unaudited)

4

5

Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2017March 31, 2020 and 2016 (Unaudited)2019 (unaudited)

5

6

Condensed Consolidated Statements of Stockholders’ Equity (Deficiency) for each of the nine monthsthree-month periods ended September 30, 2017March 31, 2020 and 2016 (Unaudited)2019 (unaudited)

6

7

Condensed Consolidated Statements of Cash Flows for the ninethree months ended September 30, 2017March 31, 2020 and 2016 (Unaudited)2019 (unaudited)

7

8

Notes to Condensed Consolidated Financial Statements

8

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

17

20

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

25

27

Item 4.

Controls and Procedures

26

27

Part

PART II

OTHER INFORMATION

Item 1.

Legal Proceedings

27

28

Item 1A.

Risk Factors

27

28

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

27

32

Item 3.

Defaults Upon Senior Securities

27

32

Item 4.

Mine Safety Disclosures

27

32

Item 5.

Other Information

28

32

Item 6.

Exhibits

28

Item 6.

SignaturesExhibits

33

29

SIGNATURES

34

 

3


SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARYPart I. Financial Statements

Condensed Consolidated Balance Sheets

(In thousands)

  September 30,  December 31, 
  2017  2016 
  (Unaudited)     
ASSETS        
Current assets:        
Cash $639  $539 
Money market funds  12,705   10,336 
Accounts receivable, net  668   274 
Inventories, net  3,245   3,416 
Prepaid expenses and other current assets  462   717 
         
Total current assets  17,719   15,282 
         
Property and equipment, net  1,327   1,489 
Deposits and other assets  35   39 
         
Total assets $19,081  $16,810 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $826  $1,156 
Accrued expenses  2,330   2,088 
Accrued compensation expense  2,266   1,600 
Accrued clinical trial expenses  623   629 
Deferred revenue  64   85 
Deferred grant revenue     104 
         
Total current liabilities  6,109   5,662 
         
Commitments and contingencies        
         
Stockholders’ equity:        
Preferred stock, no par value, 10,000 shares authorized; none outstanding      
Common stock, no par value; 200,000 shares authorized; shares issued and outstanding: 56,806 and 42,701 at September 30, 2017 and December 31, 2016, respectively  200,867   186,769 
Common stock to be issued  86   153 
Additional paid-in capital  39,559   30,697 
Notes receivable to finance stock option exercises     (2)
Accumulated other comprehensive loss  (572)  (608)
Accumulated deficit  (226,968)  (205,861)
         
Total stockholders’ equity  12,972   11,148 
         
Total liabilities and stockholders’ equity $19,081  $16,810 

The accompanying notes are an integral part of these condensed consolidated financial statements.  

Item 1. Financial Statements

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Balance Sheets

(in thousands)

 

 

March 31,

 

 

December 31,

 

 

 

2020

 

 

2019

 

 

 

(unaudited)

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

2,339

 

 

$

11,327

 

Accounts receivable, net

 

 

 

 

 

455

 

Inventories, net

 

 

 

 

 

1,029

 

Assets held-for-sale

 

 

400

 

 

 

 

Prepaid expenses and other current assets

 

 

926

 

 

 

299

 

Total current assets

 

 

3,665

 

 

 

13,110

 

Property and equipment, net

 

 

232

 

 

 

1,122

 

Right-of-use assets

 

 

 

 

 

2,342

 

Deposits and other assets

 

 

7

 

 

 

25

 

Total assets

 

$

3,904

 

 

$

16,599

 

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,588

 

 

$

1,093

 

Accrued expenses

 

 

1,575

 

 

 

1,889

 

Accrued compensation expense

 

 

885

 

 

 

2,698

 

Accrued clinical trial expenses

 

 

733

 

 

 

707

 

Current operating lease liabilities

 

 

106

 

 

 

237

 

Contract liabilities

 

 

335

 

 

 

335

 

Total current liabilities

 

 

5,222

 

 

 

6,959

 

Long term operating lease liabilities

 

 

 

 

 

2,365

 

Total liabilities

 

 

5,222

 

 

 

9,324

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders’ equity (deficiency):

 

 

 

 

 

 

 

 

Preferred stock, no par value, 10,000 shares authorized; none outstanding

 

 

 

 

 

 

Common stock, no par value; 300,000 shares authorized; shares issued and

   outstanding: 15,657 and 15,643 as of March 31, 2020 and December 31,

   2019, respectively

 

 

264,003

 

 

 

264,008

 

Additional paid-in capital

 

 

48,892

 

 

 

48,613

 

Accumulated other comprehensive loss

 

 

(543

)

 

 

(562

)

Accumulated deficit

 

 

(313,670

)

 

 

(304,784

)

Total stockholders’ equity (deficiency)

 

 

(1,318

)

 

 

7,275

 

Total liabilities and stockholders’ equity (deficiency)

 

$

3,904

 

 

$

16,599

 

See accompanying notes.

4


SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Statements of Operations (Unaudited)(unaudited)

(Inin thousands, except per share data)

 

  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
  2017  2016  2017  2016 
             
Net sales $1,610  $1,180  $4,855  $3,270 
Cost of sales  1,001   2,615   3,255   6,768 
Gross profit (loss)  609   (1,435)  1,600   (3,498)
                 
Operating expenses:                
Research and development, net of grants  1,826   1,588   5,622   3,266 
Clinical and regulatory  629   609   1,927   1,955 
Selling and marketing  2,375   2,262   7,057   6,473 
General and administrative  2,528   2,605   8,170   7,635 
Total operating expenses  7,358   7,064   22,776   19,329 
                 
Loss from operations  (6,749)  (8,499)  (21,176)  (22,827)
Interest income  33   10   69   18 
                 
Net loss $(6,716) $(8,489) $(21,107) $(22,809)
                 
Net loss per common share – basic and diluted $(0.12) $(0.20) $(0.40) $(0.57)
                 
Weighted average common shares outstanding – basic and diluted  56,799   42,220   53,206   39,929 

The accompanying notes are an integral part of these condensed consolidated financial statements 

 

 

Three Months Ended

March 31,

 

 

 

2020

 

 

2019

 

Net sales

 

$

 

 

$

1,128

 

Cost of sales

 

 

 

 

 

731

 

Gross profit

 

 

 

 

 

397

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development, net of grants

 

 

3,887

 

 

 

2,183

 

Clinical and regulatory, net of grants

 

 

914

 

 

 

1,006

 

Selling and marketing

 

 

701

 

 

 

2,103

 

General and administrative

 

 

2,021

 

 

 

2,449

 

Restructuring charges

 

 

1,381

 

 

 

2,424

 

Total operating expenses

 

 

8,904

 

 

 

10,165

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(8,904

)

 

 

(9,768

)

Interest income

 

 

18

 

 

 

68

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(8,886

)

 

$

(9,700

)

 

 

 

 

 

 

 

 

 

Net loss per common share – basic and diluted

 

$

(0.57

)

 

$

(0.80

)

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding – basic and diluted

 

 

15,649

 

 

 

12,071

 

 

See accompanying notes.

5


SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Statements of Comprehensive Loss (Unaudited)(unaudited)

(Inin thousands)

 

  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
  2017  2016  2017  2016 
             
Net loss $(6,716) $(8,489) $(21,107) $(22,809)
                 
Other comprehensive income (loss):                
Foreign currency translation adjustments  (86)  34   36   57 
Comprehensive loss $(6,802) $(8,455) $(21,071) $(22,752)

The accompanying notes are an integral part of these condensed consolidated financial statements. 

 

 

Three Months Ended

March 31,

 

 

 

2020

 

 

2019

 

Net loss

 

$

(8,886

)

 

$

(9,700

)

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

19

 

 

 

(8

)

Comprehensive loss

 

$

(8,867

)

 

$

(9,708

)

 

See accompanying notes.

6


SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)(Deficiency) (unaudited)

(Inin thousands)

 

 

 

 

Common Stock

 

 

 

Additional

Paid-in

 

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

 

Total

Stockholders’

 

 

 

 

Shares

 

Amount

 

 

 

Capital

 

 

 

Loss

 

 

Deficit

 

 

 

Equity

 

Balance, December 31, 2018

 

 

9,542

 

 

$

229,019

 

 

$

44,111

 

 

$

(575

)

 

$

(269,471

)

 

$

3,084

 

Adoption of ASC Topic 842-Leases

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(144

)

 

 

(144

)

Issuance of shares of common stock and

   warrants in connection with rights offering,

   net of issuance costs

 

 

5,976

 

 

 

34,399

 

 

 

 

 

 

 

 

 

 

 

 

34,399

 

Release of restricted stock units

 

 

7

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrants modification (see note 7)

 

 

 

 

 

 

 

 

1,577

 

 

 

 

 

 

(1,577

)

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

898

 

 

 

 

 

 

 

 

 

898

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,700

)

 

(9,700)

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(8

)

 

 

 

 

 

(8

)

Balance, March 31, 2019

 

 

15,525

 

 

$

263,418

 

 

$

46,586

 

 

$

(583

)

 

$

(280,892

)

 

$

28,529

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

Additional

Paid-in

 

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

 

Total

Stockholders’

 

 

 

 

Shares

 

 

 

Amount

 

 

 

Capital

 

 

 

Loss

 

 

Deficit

 

 

 

Equity(Deficiency)

 

Balance, December 31, 2019

 

 

15,643

 

 

$

264,008

 

 

$

48,613

 

 

$

(562

)

 

$

(304,784

)

 

$

7,275

 

Repurchase of fractional shares in connection

   with reverse stock split

 

 

(2

)

 

 

(11

)

 

 

 

 

 

 

 

 

 

 

 

(11

)

Issuance of shares of common stock

 

 

1

 

 

 

6

 

 

 

 

 

 

 

 

 

 

 

 

6

 

Release of restricted stock units

 

 

15

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

279

 

 

 

 

 

 

 

 

 

279

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,886

)

 

(8,886

)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

19

 

 

 

 

 

 

19

 

Balance, March 31, 2020

 

 

15,657

 

 

$

264,003

 

 

$

48,892

 

 

$

(543

)

 

$

(313,670

)

 

$

(1,318

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine months ended September 30, 2017 and 2016See accompanying notes.

7

  Common Stock  Common Stock
Issuable
  Additional
Paid-in
  Notes
Receivable
for Stock
Option
  Accumulated
Other
Comprehensive
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Shares  Amount  Capital  Exercises  Loss  Deficit  Equity 
Balance, December 31, 2015  35,942  $166,049   33  $205  $27,277  $(5) $(581) $(172,682) $20,263 
Issuance of common stock in connection with rights offering, net of expenses  5,978   19,430                     19,430 
Exercise of stock options  95   478            3         481 
Stock-based compensation expense              2,581            2,581 
Fair value of stock options issued for services in connection with rights offering              53            53 
Stock issued or issuable for professional services  82   324   (7)  (118)              206 
Issuance of common stock in connection with Employee Stock Purchase Plan  102   337                     337 
Issuance of RSUs  48                         
Comprehensive loss:                                    
Net loss                       (22,809)  (22,809)
Foreign currency translation adjustment                    57      57 
Comprehensive loss                    57   (22,809)  (22,752)
Balance, September 30, 2016  42,247  $186,618   26  $87  $29,911  $(2) $(524) $(195,491) $20,599 
                                     
Balance, December 31, 2016  42,701  $186,769   77  $153  $30,697  $(2) $(608) $(205,861) $11,148 
Issuance of common stock and warrants in connection with rights offering, net of offering costs  13,653   13,647         6,021            19,668 
Issuance of common stock in connection with Employee Stock Purchase Plan  193   189                     189 
Fair value of stock options issued for services in connection with rights offering              20            20 
Common stock issued or issuable for services  223   262   (2)  (67)              195 
Issuance of RSUs  36                         
Stock-based compensation expense              2,821            2,821 
Repayment of notes receivable for stock option exercises                 2         2 
Comprehensive loss:                                    
Net loss                       (21,107)  (21,107)
Foreign currency translation adjustment                    36      36 
Comprehensive loss                    36   (21,107)  (21,071)
Balance, September 30, 2017  56,806  $200,867   75  $86  $39,559  $  $(572) $(226,968) $12,972 

The accompanying notes are an integral part of these condensed consolidated financial statements. 

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Statements of Cash Flows (Unaudited)

(Inin thousands)

 

  Nine Months Ended September 30, 
  2017  2016 
       
Cash flows from operating activities:        
Net loss $(21,107) $(22,809)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization of property and equipment  345   311 
Stock-based compensation  2,821   2,581 
Bad debt (recovery) expense  (128)  191 
Excess inventory (recovery) reserve  (1,731)  2,611 
Common stock issuable for services  195   206 
Changes in operating assets and liabilities:        
Accounts receivable  (311)  874 
Inventories  1,955   (166)
Prepaid expenses and other assets  261   492 
Accounts payable  (299)  (16)
Accrued expenses  233   (377)
Accrued compensation expenses  668   (15)
Accrued clinical trial expenses  (6)  (61)
Deferred revenue  (25)  (135)
Deferred grant revenue  (104)  (1,741)
Net cash used in operating activities  (17,233)  (18,054)
         
Cash flows from investing activities:        
Purchases of property and equipment  (181)  (406)
Investment in money market funds  (2,362)  (1,820)
Net cash used in investing activities  (2,543)  (2,226)
         
Cash flows from financing activities:        
Net proceeds from rights offering  19,688   19,483 
Proceeds from repayment of note receivable  2    
Proceeds from exercise of options and employee stock plan purchases  189   816 
Net cash provided by financing activities  19,879   20,299 
         
Effect of exchange rate changes on cash  (3)  19 
         
Cash:        
Net increase  100   38 
Balance at beginning of period  539   239 
Balance at end of period $639  $277 
         
Supplemental cash flow information:        
Non-cash financing and investing activities:        
Fair value of stock options issued for services rendered in connection with rights offering $20  $53 

The accompanying notes are integral part of these condensed consolidated financial statements.

 

 

Three Months Ended March 31,

 

 

 

2020

 

 

2019

 

 

 

(unaudited)

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(8,886

)

 

$

(9,700

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

106

 

 

 

99

 

Stock-based compensation

 

 

279

 

 

 

898

 

Non-cash lease expense

 

 

3

 

 

 

6

 

Restructuring charges-inventory and fixed asset impairment

 

 

1,115

 

 

 

2,424

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

455

 

 

 

(95

)

Inventories

 

 

(112

)

 

 

(786

)

Prepaid expenses and other assets

 

 

(610

)

 

 

236

 

Accounts payable

 

 

497

 

 

 

297

 

Accrued expenses

 

 

286

 

 

 

(57

)

Accrued compensation expenses

 

 

(1,813

)

 

 

(609

)

Accrued clinical trial expenses

 

 

26

 

 

 

84

 

Contract liabilities

 

 

 

 

 

53

 

Net cash used in operating activities

 

 

(8,654

)

 

 

(7,150

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(331

)

 

 

(37

)

Net cash used in investing activities

 

 

(331

)

 

 

(37

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Net proceeds from sale of common stock and/or warrants

 

 

6

 

 

 

34,399

 

Repurchase of fractional shares in connection with reverse stock split

 

 

(11

)

 

 

 

Net cash (used in) provided by financing activities

 

 

(5

)

 

 

34,399

 

Effect of exchange rate changes on cash and cash equivalents

 

 

2

 

 

 

(1

)

Cash and cash equivalents:

 

 

 

 

 

 

 

 

Net increase (decrease)

 

 

(8,988

)

 

 

27,211

 

Balance at beginning of period

 

 

11,327

 

 

 

4,471

 

Balance at end of period

 

$

2,339

 

 

$

31,682

 

 

See accompanying notes.

8


SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Notes to Condensed Consolidated Financial Statements (Unaudited)

Three and Nine Months Ended September 30, 2017 and 2016(unaudited)

 

1. Organization and Business Operations

Second Sight Medical Products, Inc. (“Second Sight”Sight,” “we,” “us,” or “the Company”), formerly Second Sight LLC, was founded in 1998 as a limited liability company and was subsequently incorporated in the State of California in 2003. Second Sight develops manufactures and markets implantable prosthetic devices that can restore some functional visionvisual prosthetics to patients blinded by outer retinal degenerations, such as Retinitis Pigmentosa.

potentially enable blind individuals to achieve greater independence.

In 2007, Second Sight formed Second Sight Medical Products (Switzerland) Sarl,Sàrl, initially to manage clinical trials for its products in Europe, and later to manage sales and marketing in Europe, the Middle East and Asia.Asia-Pacific, and more recently for the research of future technologies. As the laws of Switzerland require at least two corporate stockholders, Second Sight Medical Products (Switzerland) SarlSàrl is 99.5% owned directly by the Companyus and 0.5% is owned by an executive of Second Sight who is acting as a nominee of the Company.March 31, 2020. Accordingly, Second Sight Medical Products (Switzerland) SarlSàrl is considered 100% owned for financial statement purposes and is consolidated with Second Sight for all periods presented.

We are currently developing the Orion® Visual Cortical Prosthesis System (“Orion”), an implanted cortical stimulation device intended to provide useful artificial vision to individuals who are blind due to a wide range of causes including retinitis pigmentosa (RP), glaucoma, diabetic retinopathy, optic nerve injury or disease, or forms of cancer and trauma. The FDA granted Breakthrough Devices Program designation for Orion. A feasibility study of the Orion device is currently underway at the Ronald Reagan UCLA Medical Center in Los Angeles (“UCLA”) and Baylor College of Medicine in Houston (“Baylor”).

SinceOur first product that was commercially approved, the Argus® II retinal prosthesis system (“Argus II”), entered clinical trials in 2006, received CE Mark approval for marketing and sales in the European Union (“EU”) in 2011, and received approval by the United States Food and Drug Administration (“FDA”) for marketing and sales in the United States in 2013. We began selling the Argus II in Europe at the end of 2011, Saudi Arabia in 2012, the United States and Canada in 2014, Turkey in 2015, Iran, Taiwan, South Korea and Russia in 2017, and Singapore in 2018. Given the limited addressable market of Argus II, we no longer market the Argus II and have focused all of our resources on the development of Orion.

In March 2020, we were severely adversely impacted by the COVID-19 pandemic and its related effects on our ability to finance our planned activities. As a result, we significantly reduced our staff and expenses and conserved liquidity as we continue operations and explore strategic options. These options include securing additional funding and exploring business alternatives that may include partnering, acquiring, investing in or combining with businesses that may or may not be in a related industry. No assurances can be given that any of these initiatives will occur.

Liquidity and Going Concern

From inception, our operations have been funded primarily through the Company hassales of our common stock and warrants, as well as from the issuance of convertible debt, research and clinical grants, and limited product revenue generated limited revenues from the sale of products andour Argus II product. Funding of our business since 2017 has financed its operationsbeen primarily through the issuanceprovided by:

Issuance of shares of common stock on May 5, 2020 which provided net proceeds of approximately $6.6 million.

Issuance of common stock convertible debt (which has been converted into common stock), and grants primarily from government agencies.

On March 6, 2017, the Company successfully completedwarrants in a registered Rights Offering to existing stockholders raisingin February 2019 which provided $34.4 million of net cash proceeds

Issuances of common stock through our At Market Issuance Sales Agreement during the fourth quarter of 2019 which provided $0.1 million of net cash proceeds

Issuances of common stock through our At Market Issuance Sales Agreement during the first quarter of 2018, which provided $4.0 million of net cash proceeds

Issuances of common stock via stock purchase agreements in May, August, October and December 2018, which provided net cash proceeds of $22.0 million

Revenue of $3.4 million and $6.9 million, for the years ended December 31, 2019 and 2018, respectively, generated by sales of our Argus II product

On May 5, 2020, we closed our underwritten public offering of 7,500,000 shares of common stock at an offering price of $1.00 per share for aggregate net proceeds of approximately $19.7$6.6 million.

We received an award for $1.6 million grant (with the intent to fund $6.4 million over five years subject to annual review and approval) from the National Institutes of Health (NIH) to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis” that commenced in January 2018. Our second year grant was recently approved under this grant. As of March 31, 2020 we recorded $0.3 million of deferred grant costs, included in prepaid expenses and other current assets, associated with this grant which it sold 13.7were offset with the related grant funds when received in April 2020.

9


On September 17, 2019, we received a $2.4 million, Units at $1.47 per Unit, which wasfour-year grant from the closing priceNational Institutes of Health (NIH) to develop spatial localization and mapping technology (“SLAM”). This grant involves a joint collaboration with the Johns Hopkins University Applied Physics Laboratory (APL), and is intended to speed the integration of SLAM into future generations of Orion. The goal is to give Orion users the ability to localize objects and navigate landmarks in unfamiliar surroundings in real time. APL is the primary recipient of the Company’s common stockgrant. We have suspended our activities on that date.the project until we clarify our future plans.

In a rights offering completed on February 22, 2019, we sold approximately 5,976,000 million units, each priced at $5.792 for net proceeds of approximately $34.4 million. Each Unitunit consisted of a share of the Company’s common stock and a warrant to purchase an additional share of the Company’s stock for $1.47. The warrants have a five-year life and trade on Nasdaq under the symbol EYESW. At the Company’s discretion, the warrants are redeemable on 30 days’ notice (i) at any time 24 months after the date of issuance, (ii) if the shares of its common stock are trading at 200% or higher than the Subscription Price for 15 consecutive trading days and (iii) if all of the independent directors vote in favor of redeeming the warrants. Holders may be able to sell or exercise warrants prior to any announced redemption date and the Company will redeem outstanding warrants not exercised by the announced redemption date for a nominal amount of $0.01 per Warrant. The Company deemed it appropriate not to record the liability for this warrant redemption amount as the probability of any redemptions was deemed remote based upon its terms. For purposes of recording this transaction, the Company allocated the proceeds from the offering between the common stock and warrants issued based on their relative fair values on the date of issuance. The fair value used for the common stock was the closing price of the stock of $1.47 on March 6, 2017. The fair value used for the warrants was their Black-Scholes value of $0.64 per warrant, calculated as of March 6, 2017. Accordingly, the relative fair value assigned to the common stock was $1.02 perone share and the relative fair value assigned to the warrants was $0.45 per warrant. The Company is using these proceeds to invest in its business to expand sales and marketing efforts, enhance current products, gain regulatory approvals for additional indications, and continue research and development into next generation technology.

The Company evaluated the financial impact of FASB ASC 260, “Earnings per Share,” which states, among other things, that if a rights issue is offered to all existing stockholders atone immediately exercisable warrant having an exercise price that is less than the fair valueof $11.76 per share. Entities controlled by Gregg Williams, our Chairman of the stock, thenBoard of Directors, acquired approximately 5,180,000 million units in the weighted average shares outstandingoffering for an aggregate investment of approximately $30 million.

In November 2017, we entered into an At Market Issuance Sales Agreement (“Sales Agreement”) with B. Riley FBR Inc. and basicH.C. Wainwright & Co., LLC, as agents (“Agents”) pursuant to which we offered and diluted earnings per share shall be adjusted retroactivelysold, from time to reflect the bonus elementtime through either of the rightsAgents, shares of our common stock having an aggregate offering for all periods presented. The Company determined thatprice as set forth in the applicationSales Agreement and a related prospectus supplement filed with the SEC. We agreed to pay the Agents a cash commission of this specific provision3.0% of ASC 260 was immaterial to previously issued financial statementsthe aggregate gross proceeds from each sale of shares under the Sales Agreement. During January and therefore, did not retroactively adjust previously reported weighted averageFebruary 2018, we sold approximately 278,000 shares outstanding and basic and diluted earnings per share.of common stock which provided net proceeds of $4.0 million under the Sales Agreement. During December 2019, we sold approximately 17,000 shares of common stock which provided net proceeds of $0.1 million under the Sales Agreement. In April 2020, we terminated the Sales Agreement with the Agents.

 

The Company’sOur financial statements have been presented on the basis that itsour business is a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company isWe are subject to the risks and uncertainties associated with a business with one product line and limited commercial product revenues,no revenue that is developing a novel medical device, including limitations on itsour operating capital resources and uncertain demand for its products. The Company hasresources. We have incurred recurring operating losses and negative operating cash flows since inception, and expectswe expect to continue to incur operating losses and negative operating cash flows for at leastthe foreseeable future.  

As more fully described in Note 11, we have been notified by the Nasdaq stock market regarding our non-compliance with the continued listing requirement on the Nasdaq capital market pursuant to its listing rules, and therefore we could be subject to delisting if we do not regain compliance within the compliance period (or the compliance period as may be extended).

Based upon our current plans we do not have sufficient funds to support our operations for the next several years as a result12 months from the date of which, management has concluded that there isissuance of these financial statements. Accordingly, these and other related factors raise substantial doubt about the Company’sour ability to continue as a going concern. We anticipate that we will seek to additionally fund our operations through public or private equity or debt financings, grants, collaborations, strategic partnerships or other sources. However, we may be unable to raise additional capital or enter into such other arrangements when needed on favorable terms or at all. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or any other approved product candidates, or we may be unable to maintain our current limited operations, maintain our current organization and reduced employee base or otherwise capitalize on our business opportunities, as desired, which could materially and adversely affect our business, financial condition and results of operations. The Company’saccompanying financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.

Our independent registered public accounting firm, in its report on the Company’s 2016our 2019 consolidated financial statements, has also raised substantial doubt about the Company’sour ability to continue as a going concern.

The Company believes that it has sufficient funds to last through the first quarter of 2018. To continue business operations beyond that point, the Company will need to raise additional debt and/or equity capital. However, there can be no assurances that the Company will be able to secure any such additional financing on acceptable terms and conditions, or at all so as to be able to continue operating its business at current levels past the first quarter of 2018. If cash resources become insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its technology and product development programs and/or clinical trials, or obtain funds, if available (although there can be no certainty), through strategic alliances that may require the Company to relinquish rights to its products, or to discontinue its operations entirely. 

2. Basis of Presentation, Significant Accounting Policies and Recent Accounting Pronouncements

Basis of Presentation

The accompanyingThese unaudited condensed consolidatedinterim financial statements have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and following the rules and regulationsrequirements of the United States Securities and Exchange Commission (“SEC”) for Form 10-Q. Accordingly,interim reporting. As permitted under those rules, certain footnotes or other financial information and footnote disclosuresthat are normally included inrequired by GAAP can be condensed or omitted. In our opinion, the unaudited interim financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. The condensed consolidated balance sheet at December 31, 2016 has been derived fromprepared on the Company’ssame basis as the audited consolidated financial statements.

In the opinion of management, these financial statements reflectand include all adjustments, which include only normal recurring and other adjustments, necessary for athe fair presentation.presentation of our financial position and our results of operations and cash flows for periods presented. These consolidated financial statements do not include all disclosures required by GAAP and should be read in conjunction with the audited consolidatedour financial statements includedand accompanying notes for the fiscal year ended December 31, 2019, contained in the Company’sour Annual Report on Form 10-K forfiled with the year ended December 31, 2016. OperatingSEC on March 19, 2020. The results forof the interim periods are not necessarily indicative of operatingthe results expected for an entirethe full fiscal year or any other interim period or any future periods.year or period.

10


Reverse Stok Split

Significant Accounting PoliciesOn December 31, 2019 we effected a reverse stock split of the outstanding shares of our no par value common stock and outstanding warrants to purchase our common stock by a ratio of 1-for-8 (1:8). The common stock and warrants began trading on the Nasdaq Capital Market on a split-adjusted basis on January 6, 2020.

 

The Company’saccompanying consolidated financial statements and notes thereto give retrospective effect to the reverse stock split for all periods presented. All issued and outstanding common stock, options and warrants exercisable for common stock, restricted stock units, and per share amounts contained in our consolidated financial statements have been retrospectively adjusted.

Significant Accounting Policies

Segment Reporting. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. Our chief operating decision-maker reviews financial information presented on a consolidated basis. Accordingly, we consider ourselves to be in a single reporting segment, specifically the discovery, development and commercialization of visual cortical prosthetics for profoundly blind individuals. We historically managed our Argus II and Orion programs on a consolidated basis within this single operating segment and do not assess the performance of our product lines or geographic regions on other measures of income or expense, such as program expense, operating income or net income. Our underlying technology consists of hardware components (implanted and wearable) and software. A vast majority of this underlying technology is shared between our Argus II and Orion branded systems. While we have ceased marketing the Argus II product indicated for individuals with retinitis pigmentosa, we are developing Orion as a next generation product with potential to treat a broader market of blind individuals, including the retinitis pigmentosa market.

Based upon our decision on May 10, 2019 to accelerate our transition to the Orion platform and suspend production of Argus, we recorded impairment charges of $2.4 million related to inventory of Argus II in the three months ended March 31, 2019. As part of this transition we commenced a corporate restructuring plan to focus on development of Orion and other key research projects. On March 31, 2020, due to the COVID-19 pandemic and related inability to secure additional funding, we laid off the majority of our employees and reduced our operating expenses significantly to allow for our continuing business operations. Due to our focus on Orion and wind down of selling and marketing activities related to Argus II, we recorded further impairment charges to our inventory of $0.5 million. In addition, we recorded an impairment of $0.7 million to our fixed assets used primarily for Argus activities and $0.2 million in severance payments all of which were paid in May 2020. We continue to advance the development of our Orion technology and are exploring various strategic options, however we cannot assure that any of these endeavors will yield satisfactory results or that we will be able to maintain our operations.

Our significant accounting policies are set forth in Note 2 of the financial statements in itsour Annual Report on Form 10-K for the year ended December 31, 2016.2019.

Net Operating Loss Carryforwards

As of December 31, 2016 pursuant to an analysis done under Section 382, Limitations on Net Operating Losses, of the Internal Revenue Code of 1986, as amended, the Company had $142.3 million and $93.8 million of federal and state operating loss carryforwards, respectively, with which to offset any future taxable income. The federal and state net operating loss carryforwards will begin to expire at various dates from 2016 through 2036. If these loss carryforwards are unavailable for use in future periods, the Company’s results of operations and financial position may be adversely affected.

The Company experienced an “ownership change” within the meaning of Section 382(g) of the Internal Revenue Code of 1986, as amended, during the second quarter of 2017. The ownership change will subject the Company’s net operating loss carryforwards to an annual limitation, which will significantly restrict the Company’s ability to use them to offset taxable income in periods following the ownership change. In general, the annual use limitation equals the aggregate value of the Company’s stock at the time of the ownership change multiplied by a tax-exempt interest rate specified by the Internal Revenue Service. The Company has analyzed the available information to determine the amount of the annual limitation. Based on information available to the Company, the limitation arising from this ownership change is estimated to range between $1.4 million and $3.7 million annually. In total, the Company estimates that the 2017 ownership change will result in approximately $102 million and $54 million of federal and state net operating loss carryforwards, respectively, expiring unused.  

RecentRecently Issued Accounting Pronouncements

In May 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-09-Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which provides new guidance for revenue recognition. The Financial Accounting Standards Board (“FASB”) subsequently issued ASU No. 2015-14-Revenue from Contracts with Customers (Topic 606), which deferred the effective date of ASU 2014-09, ASU No. 2016-08-Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net),ASU No. 2016-10-Revenue fromContracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, ASU No. 2016-12-Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients, and ASU No. 2016-20-Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. The above subsequent ASUsdid not change the core principle of the guidance in ASU 2014-09. The ASUs referred to above collectively will supersede and replace the revenue recognition requirements in ASC Topic 605-Revenue Recognition, and most of the related industry specific guidance and replace them with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”).

The core principle in ASC 606 is that revenue is recognized when promised goods or services are transferred to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve that core principle, an entity should apply the following steps:

Step 1: Identify the contract(s) with a customer

Step 2: Identify the performance obligations in the contract.

Step 3: Determine the transaction price.

Step 4: Allocate the transaction price to the performance obligations in the contract.

Step 5: Recognize revenue when (or as) the entity satisfies a performance obligation.

ASU 2014-09 also creates ASC Subtopic 340-40-Other Assets and Deferred Costs-Contracts with Customers (“ASC 340-40”), which requires an entity to recognize an asset for certain types of costs related to a contract with a customer within the scope of ASC 606 and amortize the asset over a period consistent with the transfer of the goods and services to which the asset relates. Specifically, the costs required to be capitalized are (a) incremental costs of obtaining a contract with a customer and (b) costs incurred in fulfilling a contract with a customer that are not in the scope of another ASC Topic.

ASC 606 and ASC 340-40 (the “new accounting standards”) require the Company to make significant judgments and estimates.  The new accounting standards also require more extensive disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers.

The Company will adopt the new accounting standards as of January 1, 2018 using the modified retrospective transition method, in which the two new accounting standards are applied retrospectively with the cumulative effect of initially applying the new accounting standards as an adjustment to the opening balance of retained earnings at January 1, 2018, the date of initial adoption. In accordance with the modified retrospective transition method, the Company will apply the new guidance retrospectively only to contracts that are not completed contracts at January 1, 2018.

Also in accordance with the modified retrospective transition method, the Company will provide additional disclosures in its financial statements for each of the quarterly and annual reporting periods in 2018 of (a) the amount by which each financial statement line item is affected in the reporting period by the application of the new accounting standards as compared to the accounting guidance that was in effect before the change, and (b) an explanation of the reasons for significant changes identified.

The Company completed an initial assessment of adoption of ASC 606, and is currently in the process of updating that assessment to reflect changes in contractual terms and the Company’s customary business practices since completion of the initial assessment.  The Company is also assessing the ASC 606 revenue recognition policy related to a new type of revenue arrangement the Company entered into subsequent to September 30, 2017 which is expected to generate revenue in the fourth quarter of 2017.

The Company has not yet estimated the financial statement impact of the expected changes due to the adoption of ASC 606. The Company expects to complete its assessment during the fourth quarter of 2017 and will adopt the new accounting standards effective January 1, 2018.

Management doesWe do not believe that any other recently issued, but not yet effective, accounting standards, if adopted, will have a material effect on the financial statements.

3. Concentration of Risk

Credit Risk

Financial instruments that subject the Companyus to concentrations of credit risk consist primarily of cash, money market funds, and trade accounts receivable. The Company maintainsWe maintain cash and money market funds with financial institutions that management deems reputable, and at times, cash balances may be in excess of Federal Deposit Insurance Corporation and Securities Investor Protection Corporation insurance limits. The Company extendswe deem reputable. We extended differing levels of credit to our customers, and typically doesdid not require collateral.

Customer Concentration

The Company also maintains a cash balance at a bank in Switzerland, which is insured up to an amount specifiedfollowing tables provide information about disaggregated revenue by service type, customer and geographical market.

11


The following table shows our revenues by customer type during the deposit insurance agency of Switzerland.three months ended March 31, 2020 and 2019:

 

Customer Concentration

 

 

Three Months Ended

March 31,

 

 

 

2020

 

 

2019

 

Direct customers

 

$

 

 

$

946

 

Indirect customers (distributors)

 

 

 

 

 

182

 

Total

 

$

 

 

$

1,128

 

 

During the three and nine months ended September 30, 2017March 31, 2020 and 2016,2019, the following customers each comprised moregreater than 10% of our total revenues (unaudited):

 

 

Three Months
Ended

September 30, 2017

 

Three Months
Ended

September 30, 2016

 

Nine Months
Ended

September 30, 2017

 

Nine Months
Ended

September 30, 2016

 

 

Three Months Ended

March 31,

 

         

 

2020

 

 

2019

 

Customer 1   18%  0%  8%  0%

 

 

%

 

 

23

%

Customer 2   18%  0%  6%  4%

 

 

%

 

 

15

%

Customer 3   18%  0%  6%  0%

 

 

%

 

 

13

%

Customer 4   10%  0%  3%  0%

 

 

%

 

 

12

%

Customer 5   9%  0%  11%  0%

 

 

%

 

 

12

%

Customer 6   0%  21%  0%  8%

 

 

%

 

 

10

%

Customer 7   0%  12%  3%  3%

 

 

%

 

 

10

%

Customer 8   0%  11%  0%  16%
Customer 9   0%  0%  0%  10%

 

 

 

 

 

 

 

 

 

As of September 30, 2017March 31, 2020 and December 31, 2016,2019, the following customers each comprised moregreater than 10% of our total accounts receivable:

 

   September 30,  December 31, 
   2017  2016 
   (unaudited)     
Customer 1   24%  0%
Customer 2   22%  0%
Customer 3   20%  0%
Customer 4   19%  0%
Customer 5   14%  34%
Customer 6   0%  34%
Customer 7   0%  28%

10 

March 31,

2020

December 31,

2019

Customer 1

%

35

%

Customer 2

%

33

%

Customer 3

%

32

%

 

Geographic Concentration

During the three and nine months ended September 30, 2017March 31, 2020 and 2016,2019, regional revenue based on customer locations which each comprised moregreater than 10% of our total revenues, consisted of the following (unaudited):

 

 

Three Months
Ended

September 30, 2017

 

Three Months
Ended

September 30, 2016

 

Nine Months
Ended

September 30, 2017

 

Nine Months
Ended

September 30, 2016

 

 

Three Months Ended

March 31,

 

         

 

2020

 

 

2019

 

United States  72%  47%  59%  47%

 

 

%

 

 

60

%

Italy  9%  11%  11%  21%

 

 

%

 

 

23

%

Germany  5%  35%  3%  15%

Korea

 

 

%

 

 

10

%

 

 

 

 

 

 

 

 

 

Sources of Supply

Several of the components, materials and services used in the Company’s current Argus II product are available from only one supplier, and substitutes for these items cannot be obtained easily or would require substantial design or manufacturing modifications. Any significant problem experienced by one of the Company’s sole source suppliers could result in a delay or interruption in the supply of components to the Company until that supplier cures the problem or an alternative source of the component is located and qualified. Even where the Company could qualify alternative suppliers, the substitution of suppliers may be at a higher cost and create time delays that impede the commercial production of the Argus II and impact the Company’s abilities to deliver its products as may be timely required to meet demand.

Foreign Operations

The accompanying condensed consolidated financial statements as of September 30, 2017 (unaudited)March 31, 2020 and December 31, 20162019 include gross assets amounting to $2.0$1.0 million and $1.7$1.3 million, respectively, relating to operations of the Company’sour subsidiary based in Switzerland. It is possible that unanticipated events in foreign countries could disrupt the Company’sour operations.

4. Money Market Funds

Fair Value Measurements

The authoritative guidance with respect to fair value establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels, and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below.

Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required.

Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company haswe have the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities and exchange-based derivatives.

12


Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange based derivatives, mutual funds, and fair-value hedges.

Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently-traded non-exchange-based derivatives and commingled investment funds, and are measured using present value pricing models.

11 

MoneyCash equivalents, which includes money market funds, are the only financial instrument measured and recorded at fair value on the Company’sour consolidated balance sheet, and they are consideredvalued using Level 1 valuation securities. The following table presents money market fundsinputs.

Assets measured at their level within the fair value hierarchy at September 30, 2017 and December 31, 2016on a recurring basis are as follows (in thousands):

 

 Total Level 1 Level 2 Level 3 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

         
September 30, 2017 (unaudited):         

March 31, 2020 (unaudited):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds $12,705 $12,705 $  $ 

 

$

2,179

 

 

$

2,179

 

 

$

 

 

$

 

         
December 31, 2016:         

December 31, 2019:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds $10,336 $10,336 $ $ 

 

$

11,307

 

 

$

11,307

 

 

$

 

 

$

 


5. Selected Balance Sheet Detail

Accounts receivable, net

Accounts receivable consisted of the following at (in thousands):

  September 30,  December 31, 
  2017  2016 
  (Unaudited)     
Accounts receivable $757  $487 
Allowance for doubtful accounts  (89)  (213)
         
Accounts receivable, net $668  $274 

Inventories, net

Inventories consisted of the following at (in thousands):

 

 September 30, December 31, 
 2017 2016 

 

March 31,

 

 

December 31,

 

 (Unaudited)   

 

2020

 

 

2019

 

Raw materials $390  $477 

 

$

823

 

 

$

803

 

Work in process 3,378 5,032 

 

 

1,699

 

 

 

1,716

 

Finished goods  3,123  3,284 

 

 

1,282

 

 

 

2,069

 

     

 

 

3,804

 

 

 

4,588

 

 6,891 8,793 
     
Allowance for excess and obsolescence  (3,646)  (5,377)

Allowance for excess and obsolete inventory and impairment charge

 

 

(3,804

)

 

 

(3,559

)

Inventories, net $3,245 $3,416 

 

$

 

 

$

1,029

 

 

We recorded $2.4 million as an impairment charge during the three months ended March 31, 2019, related to our plans to suspend Argus II production. We recorded further impairment charges to our inventory of $0.5 million in the first quarter of 2020. Additionally, finished goods inventory amounting to approximately $0.75 million that we expect to use for our future warranty claims has been offset with the warranty accrual which is included in accrued expenses.

Property and equipment net of accumulated depreciation and amortization

Property and equipment consisted of the following at (in thousands):

 

 September 30, December 31, 
 2017 2016 

 

March 31,

 

 

December 31,

 

 (Unaudited)   

 

2020

 

 

2019

 

Laboratory equipment $2,398  $2,300 

 

$

584

 

 

$

2,724

 

Computer hardware and software 1,297 1,220 

 

 

69

 

 

 

1,672

 

Leasehold improvements 299 288 

 

 

 

 

 

304

 

Furniture, fixtures and equipment  46  45 

 

 

 

 

 

78

 

     

 

 

653

 

 

 

4,778

 

 4,040 3,853 
     
Accumulated depreciation and amortization  (2,713)  (2,364)

 

 

(421

)

 

 

(3,656

)

Property and equipment, net $1,327 $1,489 

 

$

232

 

 

$

1,122

 

 

13

12 

As a result of our decision to cease marketing of Argus II we recorded an impairment of $0.7 million related to our fixed assets used primarily for Argus activities. We have additionally reclassified $0.4 million as assets held-for-sale which represents the estimated fair value of fixed assets that we plan to sell through auction.

 

Contract Liabilities

Contract liabilities consisted of the following (in thousands):

Beginning balance as of December 31, 2019

 

$

335

 

        Consideration received in advance of revenue recognition

 

 

 

        Revenue recognized

 

 

 

Ending balance as of March 31, 2020

 

$

335

 

Product Warranties

A summary of activity of our warranty liabilities, which are included in accrued expenses, for the period ended March 31, 2020 is presented below:

Beginning balance as of December 31, 2019

 

$

1,575

         Additions

 

 

         Settlements

 

 

(60)

         Adjustments and other

 

 

        Total

 

 

1,515

        Less: Finished goods inventory expected to be used for future warranty claims

 

 

(750)

Ending balance as of March 31, 2020

 

$

765

Allowance for Doubtful Accounts

Allowance for doubtful accounts consisted of the following (in thousands):

 

Beginning balance as of December 31, 2019

 

$

117

        Additions

 

 

        Write-offs

 

 

(117)

Ending balance as of March 31, 2020

 

$

Right-of-use assets and operating lease liabilities

We lease certain office space and equipment for our use. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Lease costs are recognized in the income statement over the lease term on a straight-line basis. Depreciation is computed using the straight-line method over the estimated useful life of the respective assets. The depreciable life of assets and leasehold improvements are limited by the expected lease term. Our lease agreements do not contain any material residual value guarantees or restrictive covenants. As most of our leases do not provide an implicit rate, we used our estimated incremental borrowing rate of 10% based on the information available at commencement date in determining the present value of lease payments.

On May 18, 2020 we entered into a Letter Agreement with Sylmar Biomedical Park, LLC (the “Landlord”), pursuant to which the parties agreed to accelerate the expiration dates of our existing leases (the “Leases”), to a date not later than June 18, 2020 (“Accelerated Termination Date”). We agreed to pay the Landlord (i) $210,730 to bring the Leases current (the “Owed Rent”) and to remit (ii) a one-time early termination fee in the amount of $150,000 (the “Early Termination Amount”). Prior to the early termination agreed in this letter we were obligated to pay aggregate base rent of approximately $0.9 million and common area maintenance expenses for the term remaining under the Leases through the respective expiration dates in February 2022 and April 2023.  The Landlord acknowledged that as of the date of the Letter Agreement the Owed Rent and the Early Termination Amount constituted all amounts owing to the Landlord under the Leases. As a result of the letter agreement, we wrote down the right-of-use assets and extinguished related lease liabilities in the amounts of $2.3 million and $2.4 million, respectively. We have accrued an early termination fee of $150,000 which is included in accrued expenses and restructuring charges as of and for the three months ended March 31, 2020.                

Assets

Classification

March 31,

2020

 

December 31,
2019

 

      Non-current assets

Right-of-use assets

$

 

$

2,342

 

Liabilities

 

 

 

 

 

 

 

  Current

Current operating lease liabilities

$

106

 

$

237

 

      Long term

Long term operating lease liabilities

$

 

$

2,365

 

14


The components of lease expense for the three months ended March 31, 2020 and 2019 were as follows (unaudited):

 

For the three

months ended

March 31,

2020

 

For the three

months ended
March 31,

2019

 

Lease expense:

 

  

 

  

 

 

Operating lease expense

$

123

 

$

123

 

Short-term lease expense

 

 

 

 

Total lease expense

$

123

 

$

123

 

Cash paid for lease amounts included in the measurement of lease liabilities amounted to $121,000 and $117,000, respectively, during the three months ended March 31, 2020 and 2019.

 

6. Equity Securities

 

Increase in Authorized Shares of Common Stock Issuable

 

Non-employee membersOn June 4, 2019, our shareholders approved an amendment to our restated articles of the Boardincorporation increasing our authorized no par value shares of Directors are paid for their services in common stock on June 1 of each year based on the average closing prices for the immediately preceding twenty trading days. As of September 30, 2017, the Company accrued $86,000 for these services, which equatesfrom 200 million to 75,000300 million shares. These shares have not yet been issued and are excluded from the calculation of weighted average common shares outstanding for EPS purposes.

Potentially Dilutive Common Stock Equivalents

At September 30, 2017As of March 31, 2020 and 2016, the Company2019, we excluded the outstandingpotentially dilutive securities summarized below, which entitle the holders thereof to ultimatelypotentially acquire shares of common stock, from itsour calculations of earningsnet loss per share and weighted average common shares outstanding, as their effect would have been anti-dilutive (in thousands), as follows (unaudited):.

 

  September 30,  September 30, 
  2017  2016 
       
Long Term Investor Rights     342 
Underwriter’s warrants  802   802 
Warrants associated with convertible debt  676   1,038 
Warrants associated with March 2017 Rights Offering  13,652    
Common stock options  5,530   3,669 
Restricted stock units  95   142 
Employee stock purchase plan  220   109 
         
Total  20,975   6,102 

 

 

March 31,

 

 

 

2020

 

 

2019

 

Common stock warrants issued to underwriter of initial public offering

 

 

 

 

 

100

 

Common stock warrants issued in connection with March 2017 rights offering

 

 

1,706

 

 

 

1,706

 

Common stock warrants issued in connection with February 2019 rights offering

 

 

5,976

 

 

 

5,976

 

Common stock options

 

 

890

 

 

 

1,073

 

Restricted stock units

 

 

25

 

 

 

64

 

Employee stock purchase plan

 

 

 

 

 

56

 

 

 

 

8,597

 

 

 

8,975

 

 

7. Warrants

On February 22, 2019, we completed a registered rights offering to existing stockholders in which we sold approximately 5,976,000 units at $5.792 per unit, which was the adjusted closing price of our common stock on that date. Each Unit consisted of a share of our common stock and a warrant to purchase an additional share of our stock for $11.76. The warrants had a five-year life and trade on Nasdaq under the symbol EYESW.

On March 6, 2017, we completed a registered rights offering to existing stockholders in which we sold approximately 1,706,000 units at $11.76 per unit, which was the adjusted closing price of our common stock on that date. Each unit consisted of a share of our common stock and a warrant to purchase an additional share of our stock for $11.76. The warrants have a five-year life and have been approved for trading on Nasdaq under the symbol EYESW. As of March 31, 2020, 632 of the warrants associated with the rights offering had been exercised.

We extended the term of 1.7 million warrants issued in our March 2017 rights offering by approximately two years effective as of February 15, 2019 as part of our February 2019 rights offering. We determined the fair value of the March 2017 Warrants immediately before and after the modification. The fair value of the March 2017 Warrants after the modification was increased by approximately $1.6 million, resulting in an accounting adjustment to additional paid-in capital and accumulated deficit in the consolidated statements of shareholders’ equity. The assumptions used in the determination of fair value of the warrants before and after the extension included a risk free interest rate of 2.50% and 2.49%, expected volatility of 81% and 82%, and expected lives of 3.08 years and 5.08 years, respectively and 0% dividend yields for both.

15


A summary of warrantwarrants activity for the ninethree months ended September 30, 2017March 31, 2020 is presented below (in thousands, except per share and contractual life data) (unaudited).

 

     Weighted Average 

 

Number of

Shares

 

 

Weighted

Average

Exercise

Price

Per Share

 

 

Weighted

Average

Remaining

Contractual

Life (in Years)

 

   Weighted Remaining 
 Number of Average Contractual 
 Shares Exercise Price Life (in Years) 
Warrants outstanding at December 31, 2016 1,840 $7.72 1.80 

Warrants outstanding as of December 31, 2019

 

 

7,682

 

 

$

11.76

 

 

 

4.21

 

Issued 13,652 $1.47 

 

 

 

 

 

 

 

 

 

 

 

Exercised      

 

 

 

 

 

 

 

 

 

 

 

Forfeited or expired  (362) $5.00   

 

 

 

 

 

 

 

 

 

 

 

       
Warrants outstanding at September 30, 2017  15,130 $2.15 4.15 
       
Warrants exercisable at September 30, 2017  15,130 $2.15 4.15 

Warrants outstanding as of March 31, 2020

 

 

7,682

 

 

$

11.76

 

 

 

3.96

 

Warrants exercisable as of March 31, 2020

 

 

7,682

 

 

$

11.76

 

 

 

3.96

 

 

The intrinsic value of warrants outstanding at September 30, 2017 was $0.

13 

as of March 31, 2020 had no intrinsic value.

8. Stock-Based Compensation

Effective June 1, 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”), which replaced previous equity plans. On June 6, 2017, the shareholders approved amendments to the 2011 Plan increasing the maximum number of shares of common stock that may be issued from 7,500,000 to 9,500,000, which is offset and reduced by options previously granted under previous plans. The option price is determined by the Board of Directors but cannot be less than the fair value of the shares at the grant date. Generally, the options vest ratably over either four or five years and expire ten years from the grant date. In the event of a change of control, as defined in the 2011 Plan, vesting is accelerated.

A summary of stock option activity under our 2011 Equity Incentive Plan (“2011 Plan”) for the ninethree months ended September 30, 2017March 31, 2020 is presented below (in thousands, except per share and contractual life data) (unaudited).

 

 Number Weighted Average Weighted Average Remaining Contractual 

 

Number of

Shares

 

 

Weighted

Average

Exercise

Price

Per Share

 

 

Weighted

Average

Remaining

Contractual

Life (in Years)

 

 of Shares Exercise Price Life (in Years) 
Options outstanding at December 31, 2016 3,667 $7.23 6.27 

Options outstanding as of December 31, 2019

 

 

984

 

 

$

21.78

 

 

 

7.70

 

Granted 2,504 $1.85   

 

 

206

 

 

$

5.98

 

 

 

 

 

Exercised      

 

 

 

 

$

 

 

 

 

 

 

Forfeited or expired  (641) $5.58    

 

 

(300

)

 

$

12.45

 

 

 

 

 

       
Options outstanding at September 30, 2017  5,530 $4.98  7.56 
       
Options exercisable at September 30, 2017  2,090 $7.15  5.36 

Options outstanding as of March 31, 2020

 

 

890

 

 

$

21.27

 

 

 

3.12

 

Options exercisable as of March 31, 2020

 

 

517

 

 

$

30.34

 

 

 

2.01

 

 

The estimated aggregate intrinsic value of stock options exercisable at September 30, 2017as of March 31, 2020 was $0.zero. As of September 30, 2017,March 31, 2020, there was $5.7$1.8 million of total unrecognized compensation cost related to outstanding stock options that will be recognized over a weighted average period of 2.912.59 years.

During the ninethree months ended September 30, 2017, the CompanyMarch 31, 2020, we granted stock options to purchase 2,464,150205,701 shares of common stock to certain employees. The options are exercisable for a period of ten years from the date of grant at prices ranging from $1.13 to $1.97$5.98  per share, which was the fair value of the Company’sour common stock on the respective grant dates.date. The options generally vest over a period of four years.years . The fair value of these options, as calculated pursuant tousing the Black-Scholes option-pricing model, was determined to be $2,222,000$0.8 million ($0.55 to $0.964.05 per share). Assumptions used in using the model were anfollowing assumptions: expected term of 6.256.02 years, volatility of 48.0%78.0%, a risk-free interest rate of 1.92% to 2.14%,1.50%  and an expected dividend rate of 0%0.0%.

In During the quarter ended March 2017,31, 2020 approximately 300,000 options were canceled and expired resulting in a reduction of stock option expense for the Company granted stock options to purchase 40,000 shares of common stock to an outside attorney in connection with his services relating to the Company’s March, 2017 rights offering to stockholders. The options are exercisable for a period of four years from the date of grant at a price of $1.76 per share, which was 120% of the fair value of the Company’s common stock on the grant date of March 6, 2017. The options vested as of the date of grant. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $19,640 ($0.49 per share). Assumptions used in the model were an expected term of 4.0 years, volatility of 48.0%, a risk-free interest rate of 1.81%, and an expected dividend rate of 0%. The cost of these shares was treated as an issuance cost of the offering and was deducted from the gross proceeds from the offering.approximately $167,000. 

16


14 

The Company adopted an employee stock purchase plan (“ESPP”) starting in June 2015 for all eligible employees. On June 6, 2017, the shareholders approved an amendment to the ESPP increasing the maximum number of shares of common stock that may be issued from 250,000 to 750,000. Under the ESPP, shares of the Company’s common stock may be purchased at six-month intervals at 85% of the lower of the closing fair market value of the common stock (i) on the first trading day of the offering period or (ii) on the last trading day of the purchase period. An employee may purchase in any one calendar year shares of common stock having an aggregate fair market value of up to $25,000 determined as of the first trading day of the offering period. Additionally, a participating employee may not purchase more than 100,000 shares of common stock in any one offering period. At September 30, 2017, 435,139 shares had been purchased under the ESPP.

The following table summarizes Restricted Stock Unit (RSU)restricted stock unit (“RSU”) activity (unaudited) for the ninethree months ended September 30, 2017March 31, 2020 (in thousands, except per share data):

 

   Number
of Awards
  Weighted
Average Grant
Date Fair Value
Per Share
 
        
Outstanding as of December 31, 2016   131  $12.43 
Awarded       
Vested   (36)  12.43 
Forfeited/canceled       
Outstanding as of September 30, 2017   95  $12.43 

 

 

Number

of Shares

 

 

Weighted

Average Grant

Date Fair Value

Per Share

 

Outstanding as of December 31, 2019

 

 

61

 

 

$

5.92

 

Awarded

 

 

 

 

 

 

Vested and released

 

 

(15

)

 

 

5.92

 

Forfeited/canceled

 

 

(21

)

 

 

5.92

 

Outstanding as of March 31, 2019

 

 

25

 

 

$

5.92

 

 

As of September 30, 2017,March 31, 2020, there was $1.1$0.1 million of total unrecognized compensation cost related to the outstanding RSUs that will be recognized over a weighted average period of 1.882.89 years.

 

We adopted an employee stock purchase plan in June 2015 for all eligible employees. At March 31, 2020 the available number of shares that may be issued under the plan is 77,031.

Stock-based compensation expense recognized for stock-based awards granted under the 2011 Plan and the ESPP in the condensed consolidated statements of operations for the three and nine months ended September 30, 2017March 31, 2020 and 2016 is2019 was as follows (in thousands) (unaudited):

 

 

Three Months
Ended

September 30, 2017

 

Three Months
Ended

September 30, 2016

 

Nine Months
Ended

September 30, 2017

 

Nine Months
Ended

September 30, 2016

 

 

Three Months Ended

March 31,

 

         

 

2020

 

 

2019

 

Cost of sales $36 $80 $184 $245 

 

$

 

 

$

47

 

Research and development 71 77 203 238 

 

 

102

 

 

 

187

 

Clinical and regulatory 42 43 135 136 

 

 

15

 

 

 

34

 

Selling and marketing  116   74  321   59 

 

 

41

 

 

 

130

 

General and administrative  641  624  1,978  1,903 

 

 

121

 

 

 

500

 

Total $906 $898 $2,821 $2,581 

 

$

279

 

 

$

898

 

 

9. Risk and Uncertainties

In December 2019, an outbreak of a novel strain of coronavirus (COVID-19) originated in Wuhan, China and has since spread globally. On March 11, 2020, the World Health Organization characterized COVID-19 as a pandemic. In addition, most states in the U.S., including California, where we are headquartered, have declared a state of emergency.  The pandemic has resulted in government authorities implementing numerous measures to try to contain the virus, such as travel bans and restrictions, quarantines, shelter-in-place or stay-at-home orders, and business shutdowns.

In accordance with local and state guidelines regarding the COVID-19 pandemic, we are requiring all of our employees to work remotely unless they cannot perform their essential functions remotely, and have also suspended all non-essential travel for our employees. While a significant number of our employees may be accustomed to working remotely or working with other remote employees, much of our workforce has not historically been remote. Although we continue to monitor the situation and may adjust our current policies as more information and public health guidance becomes available, temporarily suspending travel and restricting the ability to do business in person may create operational or other challenges, any of which could harm our business, financial condition and results of operations.

In addition, our clinical trials may be affected by the COVID-19 outbreak. Patient visits in ongoing clinical trials may be delayed, for example, due to prioritization of hospital resources toward the COVID-19 outbreak, travel restrictions imposed by governments, and the inability to access sites for initiation and monitoring. For example, scheduled patient visits to our clinical sites at UCLA and Baylor were temporarily put on hold due to COVID-19 and we are in the process of planning to resume patient visits with the sites. In addition, the validation study for the revised FLORA assessment was paused due to travel requirements for its completion. Also, some of our suppliers of certain materials used in the development of our product candidates are located in areas impacted by COVID-19 which could limit our ability to obtain sufficient materials for our product candidates. COVID-19 has and will continue to adversely affect global economies and financial markets of many countries, resulting in an economic downturn that could affect demand for our product candidates, if approved, and impact our operating results. Even after the COVID-19 pandemic has subsided, we may continue to experience an adverse impact to our business as a result of the continued global economic impact of the pandemic. We could experience further harm to our business and we cannot anticipate all of the ways in which health epidemics such as COVID-19 could adversely impact our business. Although we are continuing to monitor and assess the effects of the COVID-19 pandemic on our business, the ultimate impact of the COVID-19 outbreak or a similar health epidemic is highly uncertain and subject to change.

17


COVID-19 has directly and indirectly adversely affected Second Sight and will likely continue to do so for an uncertain period of time. In March and April 2020 we laid off a substantial majority of our employees as a result of COVID-19 and an inability to obtain financing. We retain approximately 10 of our employees to oversee current operations.  The cumulative effects of COVID-19 on the Company cannot be predicted at this time, but could include, without limitation:

inability to meet warranty obligations for our Argus II products;

reputational damages of the Company and its products;

inability to raise additional funds to finance and continue our operations;

inability to maintain adequate office laboratory facilities;

inability to retain and hire experienced personnel;

inability to finalize our plan for and enroll patients into our proposed pivotal clinical  trial;

material delays or inability to complete development and commercialization of Orion;

inability to satisfy Nasdaq’s continued listing requirements and possible delisting; and

other uncertain events that may have negative impact effect on our operations.    

10. Litigation, Claims and Assessments

Twenty-oneTen oppositions have been filed by a third-partyPixium Vision are pending in the European Patent Office, each challenging the validity of a European patent owned or exclusively licensed by us.  We have filed one opposition that is currently pending in the Company.European Patent Office challenging the validity of a patent owned by Pixium Vision. The outcome of the challenges isare not certain, however, if successful, they may affect the Company’sour ability to block competitors from utilizing some of itsour patented technology in Europe. Management of the Company does nottechnology. We believe that a successful challenge will not have a material effect on the Company’sour ability to manufacture and sell itsour products, or otherwise have a material effect on the Company’sour operations.

15 

By letter received June 23, 2020 counsel for a participant in the Orion Early Feasibility Study has alleged claims against the Company for breach of contract, breach of the implied covenant of good faith and fair dealing, negligent misrepresentation, promissory estoppel and negligent infliction of emotional distress. Counsel in addition has alleged that Second Sight has violated the protocol established by the FDA for good clinical practice within this industry. As full compensation for damages arising from these claims the Company was presented with a demand for payment of $3,000,000. The Company believes that the claims asserted are without merit. The Company will seek to deter the filing of this claim. However, these claims are in the early stage and no assurance can be given that this matter will not result in litigation. To the extent a lawsuit is filed, the Company intends to vigorously defend it.

We are party to litigation arising in the ordinary course of business. It is management’sour opinion that the outcome of such matters will not have a material effect on our results of operations, however, the Company’s financial statements. results of litigation and claims are inherently unpredictable. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors

 

11. Subsequent Events

16 

 

Work Force Reductions

After our work force reduction on March 31, 2020 we initiated a further reduction on April 17, 2020 to our current employment status of 10 employees. The costs for this reduction have been recorded in the quarter ended June 30, 2020.

Employment Agreements

On May 13, 2020 we entered into an agreement with John T. Blake, our Chief Financial Officer, for an amendment to Mr. Blake’s Executive Employment Agreement dated March 21, 2018 pursuant to which we agreed to pay Mr. Blake a one-time cash bonus of $100,000 (the “Bonus”) in recognition of his services. Under the Amendment, Mr. Blake will be entitled to receive all separation amounts due to him pursuant to the Employment Agreement less the amount of Bonus in the event that his employment is terminated without cause.

On May 8, 2020, our board of directors approved payment to Patrick Ryan, our former Chief Operating Officer, of approximately $471,000 and to reimburse up to 12 months of COBRA, if elected, pursuant to the terms of Mr. Ryan’s employment agreement. Mr. Ryan was separated effective April 17, 2020.

18


Subsidiary Closure

In May 2020, we initiated the process to investigate the closure of our Swiss subsidiary due to our decision to cease marketing the Argus II product and to reduce operating expenses.

Nasdaq

On April 15, 2020, we received a letter from The Nasdaq Stock Market (“Nasdaq”) noting that as a result of Matthew Pfeffer, a member of the board and chair of the audit committee of the board, being appointed as Acting Chief Executive Officer, the Company no longer complies with Nasdaq’s independent director and audit committee requirements set forth in Nasdaq Listing Rule 5605. Consistent with Nasdaq Listing Rules 5605(b)(1)(A) and 5605(c)(4), Nasdaq will allow us a cure period in order to regain compliance as follows:

until the earlier of our next annual shareholders’ meeting or March 27, 2021; or

if the next annual shareholders’ meeting is held before September 23, 2020, then we must evidence compliance no later than September 23, 2020.

On June 1, 2020 (the “June Notification Date”), Nasdaq notified us that following the resignation of William J. Link, effective May 31, 2020, we are non-compliant with Nasdaq’s independent director and audit committee requirements as set forth in Listing Rule 5605 due to more than one vacancy on our board and audit committee. Nasdaq had previously notified us on April 15, 2020 that due to the appointment of Matt Pfeffer as Acting Chief Executive Officer of the Company, the Company no longer complied with the Listing Rules and that consistent with Listing Rules 5605(b)(1)(A) and 5605(c)(4) the Company was provided with a cure period described above in which to regain compliance. Nasdaq indicated that as a result of Mr. Link’s resignation we are no longer automatically eligible for the above described cure period and that the Company must submit a plan of compliance no later than July 16, 2020. If Nasdaq accepts our plan of compliance, we can be granted an extension of up to 180 calendar days from the June Notification Date to evidence compliance with the Listing Rules. If the plan is not accepted, we may appeal before a Nasdaq Hearing Panel.

On June 2, 2020, Nasdaq further notified us that as a result of Dr. Link’s resignation from the Company’s board and all committees thereof, effective May 31, 2020, we no longer comply with Nasdaq’s compensation committee requirements set forth in Listing Rule 5605.

However, consistent with Listing Rule 5605(d)(2) Nasdaq will provide us a cure period in order to regain compliance as follows:

until the earlier of our next annual shareholders’ meeting or May 31, 2021; or

if the next annual shareholders’ meeting is held before November 27, 2020, then we must evidence compliance no later than November 27, 2020.

We must submit to Nasdaq documentation, including biographies of any new directors, evidencing compliance with the rules no later than as described above. If we do not regain compliance by the dates set forth above, Nasdaq will provide written notification to us that our securities will be delisted, at which time we may appeal the delisting determination to a Nasdaq Hearing Panel. 

The Notice has no effect on the listing of our common stock at this time, and our common stock continues to trade on The Nasdaq Capital Market under the symbol “EYES.” We intend to regain compliance with the independent director, audit committee and compensation committee requirements under the Listing Rules however no assurance can be given that we will be able to regain compliance.

Employee Stock Purchase Plan

We completed our offer to rescind certain purchases of shares under our ESPP plan on May 27, 2020. We voluntarily offered to rescind the sale of shares of our common stock to employees who purchased those shares under the ESPP and to reimburse any losses upon the sale of our shares of our common stock for certain purchase periods because these shares may not have been exempt from registration under the Securities Act of 1933. The rescission of these share purchases resulted in the repurchase and cancelation of 39,467 shares of our common stock. The total cost for the repurchase of these shares and the reimbursement of any losses from the sale of such shares totaled approximately $270,000.  

Equity Offering

In May 2020, we completed an underwritten public offering of 7,500,000 shares of common stock at an offering price of $1.00 per share for aggregate gross proceeds of $7.5 million, and net proceeds of approximately $6.6 million after deducting underwriting discounts, commissions and other offering expenses.  

19


Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunctiontogether with theour unaudited condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q as well as our audited 20162019 financial statements and related notes included in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission (“SEC”) on March 16, 2017. In addition to historical19, 2020. Some of the information thecontained in this discussion and analysis here or set forth elsewhere in this Quarterly Report, including information with respect toourproducts,plansand throughout this Form 10-Qstrategy for our business and related financing, contains forward-looking statements that involve risks and uncertainties, including statements regarding our expected financial results in future periods. The words “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “projects,” “will,” “would,” “strategy” and assumptions. Our actualsimilar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.Examples of forward-looking statements include, among others, statements we make regarding expectations for revenues, liquidity, cash flows and financial performance, the anticipated results of our development efforts and the timing for receipt of required regulatory approvals, insurance reimbursements and product launches, our financing plans and future capital requirements,the materially adverse  impact of the recent COVID-19 coronavirus pandemic and related public health measures on our business. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from those anticipatedthe plans, intentions and expectations disclosed in thesethe forward-looking statements as a result of certain factors, including, but not limited, to those set forth underthat we make. You should read “Risk Factors” in Part II, Item 1A of this report.

Quarterly Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. We assume no obligations to update these forward-looking statements to reflect events or circumstances after the date of this Quarterly Report or to reflect actual outcomes.

Second Sight was founded in 1998 with a missionMedical Products, Inc. (NASDAQ: EYES) develops implantable visual prosthetics that are intended to develop, manufacture, and market prosthetic devices that restore somedeliver useful artificial vision to blind individuals. We are a recognized global leader in neuromodulation devices for blindness, and are committed to developing new technologies to treat the broadest populations of sight-impaired individuals.

Leveraging our 20 years of experience in neuromodulation for vision, we are developing the Orion® Visual Cortical Prosthesis System (“Orion”), an implanted cortical stimulation device intended to provide useful artificial vision to individuals who are blind due to a wide range of causes, including RP, glaucoma, diabetic retinopathy, optic nerve injury or disease and eye injury. Orion is intended to convert images captured by a miniature video camera mounted on glasses into a series of small electrical pulses. The device is designed to bypass diseased or injured eye anatomy and to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the brain’s visual cortex, where it is intended to provide the perception of patterns of light. We are conducting a six-subject Early Feasibility Study of the Orion device at the Ronald Reagan UCLA Medical Center in Los Angeles (“UCLA”) and Baylor College of Medicine in Houston (“Baylor”). Our 12 month results for the subjects indicate to us that:

We have a good safety profile. Three subjects experienced a total of eight adverse events (AEs) through the latest independent medical safety monitor meeting in December 2019 related to the device or to the surgery. One was considered a serious adverse event (SAE), and all of the adverse events were in the expected category. The one SAE was resolved quickly and did not require a hospital stay.

The efficacy data is encouraging. We measure efficacy by looking at three measures of visual function: The first is square localization, where Orion subjects sit in front of a touch screen and are asked to touch within the boundaries of a square when it appears. The second is direction of motion, where subjects are asked to identify the direction and motion of lines on a screen. The third is grating visual acuity, a measure of visual acuity that is adapted for very low vision. On square localization, five of the six subjects in our feasibility study performed significantly better with the system on than off. On direction of motion, all six performed better on than off; and on grating visual acuity, three had measurable visual acuity on the scale of this test (versus none who can do it with the device off). Another efficacy measurement of day-to-day functionality and benefit is FLORA, which stands for Functional Low-Vision Observer Rated Assessment. FLORA is an assessment performed by an independent, third-party low vision orientation and mobility specialist who spends time with each of the subjects in their homes. The specialist asks each of the subjects a series of questions and also observes them performing 15 or more daily living tasks, such as finding light sources, following a sidewalk, or sorting laundry. The specialist then determines if the system is providing a benefit, if it is neutral, or if it is actually hurting the abilities of subjects to perform these tasks. Our FLORA results show that for five of the six subjects, the Orion system is providing benefit. No peer-reviewed data is available yet for the Orion system. We reached agreement with the FDA in the fourth quarter of 2019 to utilize a revised version of FLORA as our primary efficacy endpoint in our pivotal trial for Orion, pending successful validation of the instrument.

Our principal offices are located in Sylmar, California, approximately 25 miles northwest of downtown Los Angeles. We also have an office in Lausanne, Switzerland, that manages our commercial and clinical operations in Europe, the Middle East and Asia.Angeles, California.

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Our currentfirst commercially approved product, the Argus® II Retinal Prosthesis System (“Argus II”), treats outer retinal degenerations, such as retinitis pigmentosa, which we referalso referred to as RP. The Argus II was the only retinal prosthesis approved in the United States by the Food and Drug Administration (“FDA”), and was the first approved retinal prosthesis in the world. RP is a hereditary disease, affecting an estimated 1.5 million people worldwide including about 100,000 people in the United States, that causes a progressive degeneration of the light-sensitive cells of the retina, leading to significant visual impairment and ultimately blindness. The Argus II System is the only retinal prosthesis approved in the United States by the Food and Drug Administration (FDA), and was the first approved retinal prosthesis in the world. By providing a useful formA subset of artificial vision inthese patients who otherwise have total sight loss,would be eligible for the Argus II System can provide benefits which include:

improving patients’ orientation and mobility, such as locating doors and windows, avoiding obstacles, and following the lines of a crosswalk,

allowing patients to feel more connected with people in their surroundings, such as seeing when someone is approaching or moving away,

providing patients with enjoyment from being “visual” again, such as locating the moon, tracking groups of players as they move around a field, and watching the moving streams of lights from fireworks, and

improving patients’ well-being and ability to perform activities of daily living.

since the approved baseline vision for the Argus II is worse than legally blind (20/200). We commissioned 3rd party market research to estimate the size of the RP market that resulted in an estimate of approximately 1,500 patients in the US with advanced RP that could be treated with the Argus II given the eligibility criteria of our label. We no longer market the Argus II.

The Argus II Systemsystem provides an artificial form of vision that differs from the vision of people with normal sight. It does not restore normal vision and there is no evidence that it does notcan slow or reverse the progression of the disease. Results vary among patients and while theThe majority of patients receive a significant benefit from the Argus II, however results can vary and some patients report receiving little or no benefit. By creating an artificial form of useful vision in patients who otherwise have total sight loss, the Argus II can provide benefits that include: 

restoring independence through a renewed ability to navigate independently in unfamiliar environments;

Our major corporate, clinicalimproving patients’ orientation and regulatory milestones include:mobility, such as locating doors and windows, avoiding obstacles, and following the lines of a crosswalk;

allowing patients to feel more connected with people in their surroundings, such as seeing when someone is approaching or moving away;

In 1998, Second Sight was founded.

providing patients with enjoyment from being “visual” again, such as locating the moon, tracking groups of players as they move around a field, and watching moving streams of lights from fireworks;

In 2002, we commenced clinical trials in the US for our prototype product, the Argus I retinal prosthesis.

enabling some patients to re-enter the workforce through multiple vocations that become possible because of Argus II; and

In 2007, we commenced clinical trials in the US for the Argus II System, which later became our first commercial product.

improving patients’ well-being and ability to perform activities of daily living

In 2011, we received marketing approval in Europe (CE Mark) for the Argus II System.

In 2013, we received marketing approval in the United States (FDA) for the Argus II System.

In 2014, we launched the Argus II in the US, completed our initial public offering (“IPO”), and began trading on NASDAQ under the symbol “EYES.”

In 2014, we launched the Argus II in the US, completed our initial public offering (“IPO”), and began trading on NASDAQ under the symbol “EYES.”

In 2015, we commenced a clinical trial in the UK for an expanded indication for the Argus II System in individuals with dry AMD.

We began selling the Argus II System in Europe at the end of 2011, Saudi Arabia in 2012, the United States and Canada in 2014, Turkey in 2015, andIran, Taiwan, South Korea and Russia in 2017. With2017, and Singapore in 2018. Given the exceptionlimited addressable market of TaiwanArgus II, we no longer market the Argus II and Russia,have focused all of our resources on the development of Orion.

We are also researching multiple technologies that we believe to be complimentary to artificial vision and could potentially provide significant enhancements to the Orion user experience.  In most cases, we collaborate with 3rd party firms to advance and integrate these innovative technologies with our artificial vision systems.  Examples of technologies that we believe will be complimentary to our products include: eye tracking, object recognition and localization, thermal imaging and depth-based decluttering.  

Recent developments

In March 2020, we were severely adversely impacted by the unprecedented economic shock caused by the COVID-19 pandemic and its related effects on our ability to secure financing for our planned activities. As a result, we significantly reduced our staff and expenses and conserved liquidity as we continue operations and explore strategic options. These options include securing additional funding and exploring business alternatives that may include partnering, acquiring, investing in or combining with businesses that may or may not be in a related industry. We are actively seeking opportunities to develop partnerships or collaborations with others to advance further Orion development, conduct pivotal trials and bring the product to market for the treatment of blindness. No assurances can be given that any of these initiatives will occur.

In early March 2020, we commenced clinical validation activities for the FLORA-20 instrument, the primary efficacy endpoint we have full regulatory approvalselected for our future pivotal clinical trial of Orion. In mid-March 2020, our validation activities were suspended as a result of public health concerns and related social distancing due to sellCOVID-19.  We are in these regions. the process of evaluating when activities related to the validation study can be resumed. 

On March 27, 2020, the Board of Directors appointed Matthew Pfeffer, a member of our Board and Chairman of the Audit Committee of the Board, as acting Chief Executive Officer.  As a result, in April 2020, The Nasdaq Stock Market informed us, we no longer comply with Nasdaq’s independent director and audit committee requirements set forth in Nasdaq Listing Rule 5605. Nasdaq has also advised that in order to regain compliance we must submit a plan of compliance no later than July 16, 2020.

In Taiwan and Russiafurtherance of our decision to withdraw Argus II from the market, we have limited regulatoryterminated two post-market studies for Argus II in Germany and the U.S., terminated an extended non-significant risk study in the U.S. for Argus 2s, suspended our technical support of Argus II worldwide, and withdrawn our submission to the FDA for market approval butof the Argus 2s wearables system. In addition, we arehave reported to our notified body that we do not intend to distribute the Argus 2s in Europe or other markets, and will therefore let our CE Mark lapse for that product.

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In May 2020, we completed an underwritten public offering of 7,500,000 shares of common stock at an offering price of $1.00 per share for aggregate gross proceeds of $7.5 million, and net proceeds of approximately $6.6 million after deducting underwriting discounts, commissions and other offering expenses. Based on our current plans, we believe the financing provides sufficient working capital to obtain full regulatory approvalsustain approximately six months of ongoing operations.

In May 2020, we entered into a Letter Agreement with Sylmar Biomedical Park, LLC (the “Landlord”) to terminate our facility leases in both countries. We sell primarily throughwhich we agreed to vacate the premises by June 18, 2020 and pay $210,730 to bring our direct sales force, but use distributorsleases current and pay a one-time early termination fee of $150,000. Prior to the early termination, we were obligated to pay aggregate base rent of approximately $0.9 million and common area maintenance expenses for the respective remaining terms of our leases in certain countries.February 2022 and April 2023.

As of June 10, 2020, we have reduced our employees to 10 individuals to focus on the advancement of Orion and sustain our ongoing operations.

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Going Concern

Capital Funding

From inception, our operations have been funded primarily through the sales of our common stock and warrants, as well as from the issuance of convertible debt, research and clinical grants, and limited product revenue generated byfrom the sale of our Argus II System. Duringproduct. Funding of our business since 2017 has been primarily provided by:

On May 5, 2020, we closed our underwritten public offering of 7,500,000 shares of common stock at an offering price of $1.00 per share for aggregate net proceeds of approximately $6.6 million.

Issuances of common stock and warrants in a Rights Offering in February 2019 which provided $34.4 million of net cash proceeds

Issuances of common stock through our At Market Issuance Sales Agreement during the fourth quarter of 2019 which provided $0.1 million of net cash proceeds

Issuances of common stock through our At Market Issuance Sales Agreement during the first quarter of 2018, which provided $4.0 million of net cash proceeds

Issuances of common stock via stock purchase agreements in May, August, October and December 2018, which provided net cash proceeds of $22.0 million

Revenue of $3.4 million and $6.9 million, for the years ended December 31, 20162019 and 20152018, respectively, generated by sales of our Argus II product

We received an award for $1.6 million grant (with the intent to fund $6.4 million over five years subject to annual review and approval) from the nine months endedNational Institutes of Health (NIH) to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis” that commenced in January 2018. Our second year award was recently approved under this grant. As of March 31, 2020 we recorded $0.3 million of deferred grant costs associated with this grant which were offset with the related grant funds when received in April 2020.

On September 30,17, 2019, we received a $2.4 million, four-year grant from the National Institutes of Health (NIH) to develop spatial localization and mapping technology (“SLAM”). This grant involves a joint collaboration with the Johns Hopkins University Applied Physics Laboratory, and is intended to speed the integration of SLAM into future generations of Orion. The goal is to give Orion users the ability to localize objects and navigate landmarks in unfamiliar surroundings in real time. APL is the primary recipient of the grant. We have suspended our activities on the project until we clarify our future plans.

In a rights offering completed on February 22, 2019 we sold approximately 5,976,000 units, each priced at $5.792 for net cash proceeds of approximately $34.4 million. Each unit consisted of one share and one immediately exercisable warrant having an exercise price of $11.76 per share. Entities controlled by Gregg Williams, our Chairman of the Board of Directors, acquired approximately 5,180,000 units in the offering for an aggregate investment of approximately $30 million.

In November 2017, we fundedentered into an At Market Issuance Sales Agreement (the “Sales Agreement”) with B. Riley FBR Inc. and H.C. Wainwright & Co., LLC, as agents (“Agents”) pursuant to which we offered and sold, from time to time through either of the Agents, shares of our business primarily through:

Revenue of $4.9 million in the first nine months of 2017, and $4.0 million and $8.9 million in fiscal years 2016 and 2015, respectively, generated by sales of our Argus II System,

Issuance of common stock in our Rights Offering in June 2016, which generated net proceeds of $19.5 million after offering expenses,

Issuance of common stock and warrants in our Rights Offering in March 2017, which generated net proceeds of $19.7 million after offering expenses.

Our financial statements have been presented on the basis that our business is a going concern, which contemplates the realization of assets and the satisfaction of liabilitiescommon stock having an aggregate offering price as set forth in the normal courseSales Agreement and a related prospectus supplement filed with the SEC. We agreed to pay the Agents a cash commission of business. 3.0% of the aggregate gross proceeds from each sale of shares under the Sales Agreement. During January and February 2018, we sold 278,000 shares of common stock for additional net proceeds of $4.0 million under the Sales Agreement. During December 2019, we sold approximately 17,000 shares of common stock which provided net proceeds of $0.1 million under the Sales Agreement. This agreement was terminated in April 2020.

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We are subject to the risks and uncertainties associated with a business with one product line and limited commercial product revenues, including limitations on our operating capital resources and uncertain demand for our products.no revenue that is developing a novel medical device. We have incurred recurring operating losses and negative operating cash flows since inception, and we expect to continue to incur operating losses and negative operating cash flows for the foreseeable future. Based on our current plans, we do not have sufficient funds to continue operating our business at current levels for at least twelve months from the next few years,date of issuance of this report. To finance our operations beyond that point, we will need to raise additional capital, which cannot be assured. However, our operating plan may change as a result of many factors currently unknown to us, and we will need to seek additional funds during that period, through public or private equity offerings or debt financings, grants, collaborations, strategic partnerships or other sources. However, we may be unable to raise additional capital or enter into such other arrangements when needed on favorable terms or at all. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs, or we may be unable to expand or maintain our operations, maintain our current organization and employee base or otherwise capitalize on our business opportunities, as desired, which management has concluded that there iscould materially and adversely affect our business, financial condition and results of operations. Accordingly, these factors among others raise substantial doubt about the Company’sour ability to continue as a going concern. The Company’sOur independent registered public accounting firm, in its report on the Company’s 2016our 2019 consolidated financial statements, has also raised substantial doubt about the Company’sour ability to continue as a going concern.

In June 2016, the Company successfully completed a Rights Offering to existing stockholders, raising proceeds of $19.5 million net of cash offering costs, selling 6.0 million shares of common stock at $3.315 per share, representing 85% of the Company’s per share stock price at the close of the Rights Offering.

In March 2017, the Company successfully completed a Rights Offering to existing stockholders, raising proceeds of $19.7 million net of cash offering costs, selling 13.7 million Units at $1.47 per Unit, which was the Company’s per share stock price at the close of the Rights Offering. Each Unit consisted of one share of common stock and one warrant, with a five-year life, to buy an additional share of common stock at $1.47 per share. The Company believes that it has sufficient funds to last through the first quarter of 2018. To continue business operations beyond that point, the Company will need to raise additional debt and/or equity capital. However, there can be no assurances that the Company will be able to secure any such additional financing on acceptable terms and conditions, or at all so as to be able to continue its business at current levels past the end of the first quarter of fiscal 2018. If cash resources become insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its technology and product development programs and/or clinical trials, or obtain funds, if available (although there can be no certainty), through strategic alliances that may require the Company to relinquish rights to its products, or to discontinue its operations entirely.

Global Reimbursement

Obtaining reimbursement from governmental and private insurance companies is critical to our commercial success. Due to the cost of the Argus II System, our sales would be limited without the availability of third party reimbursement. In the US, coding, coverage, and payment are necessary for the surgical procedure and Argus II system to be reimbursed by payers. Coding has been established for the device and the surgical procedure. Coverage and payment vary by payer. The majority of Argus II patients are eligible for Medicare, and coverage is primarily provided through traditional Medicare, sometimes referred to as Medicare Fee-for-Service (FFS) or Medicare Advantage. A small percentage of patients are covered by commercial insurers.

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Medicare FFS patients– Coverage is determined by Medicare Administrative Contractors (MACs) that administer various geographic regions of the US. Positive coverage decisions for the Argus II are effective in seven of 12 MAC jurisdictions (comprising 28 states). Effective January 1, 2017, the Centers for Medicare and Medicaid Services (CMS) established a 2017 payment rate of $150,000 for both the procedure and the Argus II Retinal Prosthesis System. On November 1, 2017, CMS posted a final 2018 payment rate of $122,500 for both the procedure and the Argus II Retinal Prosthesis System.

Medicare Advantage patients– Medicare Advantage plans are required to cover the same benefits as those covered by the MAC in that jurisdiction. For example, if a MAC in a jurisdiction has favorable coverage for the Argus II, then all Medicare Advantage plans in that MAC jurisdiction are required to offer the same coverage for the Argus II. Individual hospitals and ASCs may negotiate contracts specific to that individual facility, which may include additional separate payment for the Argus II implant system. In addition, procedural payment is variable and can be based on a percentage of billed charges, payment groupings or other individually negotiated payment methodologies. Medicare Advantage plans also allow providers to confirm coverage and payment for the Argus II procedure in advance of implantation.

Commercial insurer patients– Commercial insurance plans make coverage and payment rate decisions independent of Medicare, and contracts are individually negotiated with facility and physician providers.

The Company employs dedicated employees and consultants with insurance reimbursement expertise engaged to expand and enhance coverage decisions. Currently, seven Medicare jurisdictions, including  CGS (J15 -- Ohio and Kentucky), Palmetto GBA (JM -- Virginia, (excluding Part B for Arlington and Fairfax counties), West Virginia, North Carolina and South Carolina), NGS (J6 -- Minnesota, Illinois and Wisconsin), NGS (JK -- Connecticut, New York, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont), FCSO (JN -- Florida, Puerto Rico and the U.S. Virgin Islands), and Novitas (JH and JL -- Arkansas, Colorado, Delaware, District of Columbia, Louisiana, Maryland, Mississippi, New Jersey, New Mexico, Oklahoma, Pennsylvania, and Texas) provide coverage of the Argus II in 28 states, two territories and the District of Columbia when medically necessary. We are actively engaged with the remaining MACs and are committed to supporting their requests for additional information and clinical evidence. We expect that additional positive coverage decisions will be issued over time but cannot predict timing or ultimate success with each MAC.

Within Europe, we have obtained reimbursement approval or funding in Germany, France, and one region of Italy. In France, the Company was selected to receive the first “Forfait Innovation” (Innovation Bundle) from the Ministry of Health, which is a special funding program for breakthrough procedures to be introduced into clinical practice. As part of this program, the Company is conducting a post-market study in France which has enrolled a total of 18 subjects and will follow them for two years. The French program will fund implantation of up to 18 additional patients that will not be part of the post-market study. After review of the study’s results, we expect Argus II therapy to be covered and funded through the standard payment system in France, however, we can provide no assurance that the French government will continue to fund the Argus II after the first 36 implants.

In December 2016, NHS England announced it would cover 10 Argus implantations as part of a CtE program. The CtE program is especially designed for treatments that show significant promise for the future, while new clinical and patient experience data are collected within a formal evaluation program. This program is similar to the Forfait Innovation program in France. NHS England is known to be under significant financial pressure and also highly selective in adopting innovative technologies – which must demonstrate sufficient value for the cost expended. We expect first implants to occur sometime in 2018.

We are also seeking reimbursement approval in other countries including Belgium and Turkey and we are also seeking reimbursement approval in additional regions of Italy. 

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To date, our marketing activities have focused on raising awareness of the Argus II System with potential patients, implanting physicians, and referring physicians. Our marketing activities include exhibiting, sponsoring symposia, and securing podium presence at professional and trade shows, securing journalist coverage in popular and trade media, attending patient meetings focused on educating patients about existing and future treatments, and sponsoring information sessions for the Argus II System. In the United States, our efforts are currently focused on media advertisements dedicated to RP patients and their families. These advertisements are placed in geographic areas where we have Centers of Excellence committed to Argus II.

Product and Clinical Development Plans

The Argus II System is currently approved for RP patients with bare or no light perception in the US, and in Europe for severe to profound vision loss due to outer retinal degeneration, such as from retinitis pigmentosa (RP), choroideremia, and other similar conditions. The number of people who are legally blind due to RP is estimated to be about 25,000 in the US, 42,000 in Europe, and about 375,000 total worldwide. A subset of these patients would be eligible for the Argus II System since the approved baseline vision for the Argus II System is worse than legally blind (20/200).

The Company believes an opportunity exists to expand the use of its Argus II technology to better sighted individuals with RP who are currently not being treated. To achieve this market expansion, the Company is undertaking multiple clinical data collection efforts and product development efforts to improve the technology’s performance, including:

Clinical trials with better-sighted individuals;
Development of retinal stimulation programs thatOrion. By further developing our visual cortical prosthesis, Orion, we believe can achieve improved resolution by adjusting electronic retinal stimulation methods;
Redesigns of the externals (glasses, camera, and video processing unit) that will possess processing power many times greater than the current Argus II system, which will enable enhanced image processing support for the commercial implementation of the new retina stimulation protocols, possibly by 2018.

We believe we can furthermay be able to significantly expand our market to include nearly all profoundly blind individuals, other thanindividuals. The only notable exceptions for potential use of the Orion are those who are blind due to preventableotherwise currently treatable diseases, individuals who are born blind, or blindness due to braindirect damage by developing aof the visual cortical prosthesis. We refer to this product ascortex, which is rare. However, of the Orion I visual prosthesis system. We estimate thatestimated 36 million blind people worldwide, there are approximately 5.8 million people worldwide who are legally blind due to causes other than preventable conditions, RPthat are not otherwise treatable (including RP) or AMD. If approvedage-related macular degeneration (“AMD”). We continue to develop and refine our estimates of the potential addressable market size as we evaluate the commercial prospects for Orion using a combination of published sources, third party market research, and physician feedback.  We currently estimate over 500,000 individuals in the US are legally blind due to retinitis pigmentosa, glaucoma, diabetic retinopathy, optic nerve disease and eye injury. Of this population, we estimate the potential US addressable market is between 50,000 and 100,000 individuals with bi-lateral blindness at the light-perception level or worse.  Our marketing approvals by the FDA and other regulatory agencies will ultimately determine the subset of these patients who are eligible for the Orion I based on our clinical trialtrials and the associated results.

Our objective in designing and developing the Orion I visual prosthesis system is to bypass the optic nerve and directly stimulate the part of the brain responsible for human vision. In October 2017, we received final IDE approval from the FDA to begin a human feasibility studyA six-subject Early Feasibility Study of the Orion I visual prosthesis system. This studydevice is currently underway at UCLA and Baylor. Our 12 month results for six of the subjects indicate a good safety profile with encouraging efficacy data and benefits in helping subjects perform their daily living tasks.  We believe these data are encouraging and support advancement of Orion into a larger pivotal clinical study. Early promising results are not necessarily indicative of results which may be obtained in large clinical trials. No assurance can be given that we will confirm initial findingsachieve similar results in our human pilot study we announced inlarger Orion clinical trials. No peer-reviewed data is available yet for the fourth quarter of 2016 and provideOrion system.  

In November 2017, the first human data of a fully functional wireless visual cortical stimulator system includingFDA granted Breakthrough Devices Program designation for the external video camera system. We expect to implant and activate our Orion I visual prosthesis system in human subjects in late 2017.Orion. This study will provide the first human data of a fully functional wireless visual cortical stimulator system including an external video camera system. This initial study in a small number of subjects, if successful, should also form the basis for an expansiondesignation is given to a pivotal clinical trialfew select medical devices in 2018.  order to provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review.

 

We began a five-subject pilot study inCOVID-19 Pandemic

In accordance with local and state guidelines regarding the United Kingdom in June 2015,COVID-19 pandemic, we are requiring all of our employees to determine the utilitywork remotely unless they cannot perform their essential functions remotely, and have also suspended all non-essential travel for our employees. While many of the Argus II System for use in persons suffering from dry AMD. In the second quarterour employees are accustomed to working remotely, much of 2016our workforce has not historically been remote. Although we completed enrollment and continue to trackmonitor the subjects via the site in Manchester. The subjects have reportedsituation and may adjust our current policies as more information and public health guidance becomes available, temporarily suspending travel and restricting the ability to integrate their native peripheral vision with their artificial central vision. Subjects also report that they enjoy using their Argus system. To date, however,do business in person may create operational or other challenges, any of which could harm our business, financial condition and results of operations.

In addition, our clinical trials have been affected by the subjectsCOVID-19 outbreak. Patient visits in ongoing clinical trials have not demonstrated significant objective benefit over their residual vision when usingbeen delayed, for example, due to prioritization of hospital resources toward the Argus II. We planCOVID-19 outbreak, travel restrictions imposed by governments, and the inability to continue testing these subjectsaccess sites for initiation and monitoring. Also, some of our suppliers of certain materials used in the development of our product candidates are located in areas impacted by COVID-19 which could limit our ability to obtain sufficient materials for our product candidates. COVID-19 has and will submitcontinue to adversely affect global economies and financial markets, and may result in an economic downturn that could affect demand for our product candidates, if approved, and impact our operating results. Even after the COVID-19 pandemic has subsided, we may continue to experience an adverse impact to our business as a revised clinical protocolresult of the continued global economic impact of the pandemic. We cannot anticipate all of the ways in 2017. Our approacheswhich health epidemics such as COVID-19 could adversely impact our business. Although we are continuing to improvingmonitor and assess the effective resolution in RP patients may work in AMD patients, which could help us demonstrate objective benefit over their residual vision. The revised protocol will request approvaleffects of the COVID-19 pandemic on our business, the ultimate impact of the COVID-19 pandemic or a similar health epidemic is highly uncertain and subject to test new retinal stimulation programs withchange. See the existing subjects withRisk Factors section for further discussion of the belief they may benefit. If this clinical testing is successful, we plan to enroll additional patients inpossible impact of the COVID-19 pandemic on our pursuit of a solution for this large patient population.business.

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Critical Accounting Policies

and Estimates

The preparation of our condensed consolidated financial statements in conformity with generally accepted accounting principles in the United States or GAAP, requires(“GAAP”) and the requirements of the United States Securities and Exchange Commission require management to make estimates, assumptions and assumptionsjudgments that affect the amounts, liabilities, revenue and expenses reported in the financial statements and the notes to the financial statements.On an ongoing basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. A summary of our critical accounting policies is presented in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2016. 2019.

Segment Reporting

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. Our chief operating decision-maker reviews financial information presented on a consolidated basis. Accordingly, we consider ourselves to be in a single reporting segment, specifically the discovery, development and commercialization of visual cortical prosthetics for profoundly blind individuals. We historically managed our Argus II and Orion programs on a consolidated basis within this single operating segment and do not assess the performance of our product lines or geographic regions on other measures of income or expense, such as program expense, operating income or net income. Our underlying technology consists of hardware components (implanted and wearable) and software. A vast majority of this underlying technology is shared between our Argus II and Orion branded systems. While we have ceased marketing the Argus II product indicated for individuals with retinitis pigmentosa, we are developing Orion as a next generation product with potential to treat a broader market of blind individuals, including the retinitis pigmentosa market.

Based upon our decision on May 10, 2019 to accelerate our transition to the Orion platform and suspend production of Argus, we recorded impairment charges of $2.4 million related to inventory of Argus II in the three months ended March 31, 2019. As part of this transition we commenced a corporate restructuring plan to focus on development of Orion and other key research projects. On March 31, 2020, due to the COVID-19 pandemic and related inability to secure additional funding, we laid off the majority of our employees and reduced our operating expenses significantly to allow for our continuing business operations. Due to our focus on Orion and wind down of selling and marketing activities related to Argus II, we recorded further impairment charges to our inventory of $0.5 million. In addition, we recorded an impairment of $0.7 million to our fixed assets used primarily for Argus activities and $0.2 million in severance payments all of which were paid in May 2020. We continue to advance the development of our Orion technology and are exploring various strategic options, however we cannot assure that any of these endeavors will yield satisfactory results or that we will be able to maintain our operations.

There have been no other material changes to our critical accounting policies during the ninethree months ended September 30, 2017.

March 31, 2020.

Results of Operations

Net sales.Our net sales are derivedconsists of revenue primarily from the sale of our Argus II System.product which is no longer marketed. We began selling our products in Europe in 2011, Saudi Arabia in 2012,do not expect future revenues from the United States and Canada in 2014, Turkey in 2015, Russia, South Korea and Taiwan in 2017. Our objective is to increase our product revenue over the next several years as we pursue commercializationsale of our product, as our product becomes more well-known and accepted in the market, and as insurance coverage becomes more widespread.Argus II.

Cost of sales.Cost of sales includes the salaries, benefits, material, overhead, third party costs, warranty, charges for excess and obsolete inventory, and other costs required to make ourthe Argus II Systemsystem at our Sylmar,Los Angeles, California facility. In the second quarter of 2016, due to lower implant ratesOur product involves technologically complex materials and revenue, we decreased production output and increased our reserve for slow-moving inventory. As a result of the lower production levels, we have been incurring expenses for unabsorbed overhead charges. Beginning in the first quarter of 2017, based on our rolling 12-month sales forecasts, we have been reducing our reserve for slow moving inventory, which has the effect of offsetting theprocesses. We record cost of goods shipped for revenue insales when products are implanted, which may differ from the period. We expectperiod we are able to work throughrecord revenue. Such timing differences may cause our slow-moving inventory and resume normal production when and if sales orders increase. Our abilityreported results of operations to generate a gross profit in future periods will depend on our abilitybe difficult to (i) generate higher revenues and (ii)compare from period to produce our product in sufficient quantities that will allow us to absorb all production costs in a given period by spreading our costs over a larger production base, which will lower our cost per unit.period.

Operating Expenses.We generally recognize our operating expenses as we incur themincurred in four general operational categories: research and development, clinical and regulatory, sales and marketing, and general and administrative. Our operating expenses also include a non-cash component related to the amortization of deferred stock-based compensation allocated tofor research and development, clinical and regulatory, sales and marketing, and general and administrative personnel. From time to time weWe have received grants from institutions or agencies, such as the National Institutes of Health, to help fund the some of the cost of our development efforts. We have recorded the amount of funding received from these grants as offsetsreductions to the costs as they are incurred to complete the related work.operating expenses.

 

Research and development expenses consist primarily of employee compensation materials, and consulting costs related to the design, development, and enhancements of our current and potential future products, offset by grant revenue received in support of specific research projects. We expense our research and development costs as they are incurred. We expectDue to the recent downsizing of our business, we are currently evaluating the path forward for our research and development expenses to increase inactivities for Orion, including the future as we pursue further enhancements of our existing product and develop technologypotential for our potential future products, such ascollaboration with 3rd parties and/or outsourcing the Orion I visual cortical prosthesis. We also expect to receive additional grants in the future that will be offset primarily against research and development costs.engineering work for Orion.

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Clinical and regulatory expenses consist primarily of salaries, travel and related expenses for personnel engaged in clinical and regulatory functions, as well as internal and external costs associated with conducting clinical trials and maintaining relationships with regulatory agencies.agencies offset by grant revenue received in support of specific clinical research products. We expect clinical and regulatory expenses to increasebe lower in the short-run as we assess the safety and efficacy of enhancementshave closed our clinical study activities related to our current Argus II System, seekand Orion clinical site visits have been temporarily put on hold due to expandCOVID-19. In the indications for the Argus II System, such as AMD,long-run, we expect clinical and prepare to initiate clinical studies of potential future products such as the Orion I visual cortical prosthesis.

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Sales and marketing expenses consist primarily of salaries, commissions, travel and related expenses for personnel engaged in sales, marketing and business development functions, as well as costs associated with promotional and other marketing activities. We expect sales and marketingregulatory expenses to increase asif and when we hire additional sales personnel, initiate additional marketing programs, develop relationships with new distributors, and expand the numberconduct a pivotal clinical study of medical centers that buy and implant our Argus II System and any future products.Orion.

Sales and marketing expenses consist primarily of salaries, commissions, travel and related expenses for personnel engaged in sales, marketing, market access and business development functions, as well as costs associated with promotional and other marketing activities including the cost of units consumed as demos or samples. We expect sales and marketing expenses to be significantly lower in 2020 than in 2019 as we no longer employ sales and marketing personnel and no longer market the Argus II product.

General and administrative expenses consist primarily of salaries and related expenses for executive, legal, finance, human resources, information technology and administrative personnel, as well as recruiting and professional fees, patent filing costs, insurance costs and other general corporate expenses, including rent. We expect general and administrative expenses to increase as we add personnel and incur additional costs related to the growth of our business and operate as a public company.

General and administrative expenses consist primarily of salaries and related expenses for executive, legal, finance, human resources, information technology and administrative personnel, as well as recruiting and professional fees, patent filing and annuity costs, insurance costs and other general corporate expenses, including rent. We expect general and administrative expenses to be significantly lower in 2020 as we have significantly reduced staff.

 

Comparison of the Three Months Ended September 30, 2017March 31, 2020 and 20162019

We did not implant Argus II products during the first quarter of 2020 compared to 10 in the first quarter of 2019.  Four of the implants were in Europe, the Middle East and Asia (collectively, “EMEA”) in the first quarter of 2019 while the remainder were in the U.S.

Worldwide commercial implant volume for the three and nine months ended September 30, 2017 was as follows:

  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
  2017  2016  2017  2016 
             
Europe and the Middle East  4   10   16   25 
Asia  1      5    
Canada  0      5   1 
United States  7   4   19   9 
Total  12   14   45   35 

Net Sales.Sales. Net sales increased by $430,000, or 36%, from $1,180,000was zero in the thirdfirst quarter of 20162020 as compared to $1,610,000$1.1 million in the thirdsame period in 2019. Revenue was recognized for nine units in the first quarter of 2017, which was the result of fewer implants offset by a higher amount of revenue per implant in the current year quarter.

In the third quarter implant volume outside of North America declined from 10 implants in 2016 to five implants in 2017 due, in part, to summer seasonality typical of the European market. In the U.S., we had seven implants in the third quarter of 2017 compared to four in the third quarter of 2016, as our Centers of Excellence strategy continued to gain traction. Based on implant activity through October, and the number of implants scheduled for the remainder of the quarter, we expect to see growth in implants in the fourth quarter of 2017 relative to the third quarter.

2019. Revenue recognized per implant was $134,000approximately $113,000 in the thirdfirst quarter of 2017 compared to $84,000 in2019. We do not expect future revenues from the third quartersale of 2016. The higher revenue per implant is due mainly to (i) a higher mix of implants in the U.S. and Asia where the prices tend to be higher, (ii) the higher U.S. Medicare reimbursement level in 2017 compared to 2016, and (iii) higher deferred revenue recognized in the third quarter of 2017 compared to same period of 2016. We expect our average revenue per implant for the remainder of 2017 to be in a range of $100,000 to $120,000, depending on the geographic mix of implants. In 2018, with the lower CMS rate discussed above, we expect that our average revenue per implant will be in the range of $90,000 to $105,000, depending on the geographic mix of implants.Argus II.

Cost of sales.Cost of sales decreased by approximately $1,614,000, or 62%, from $2,615,000was zero in the thirdfirst quarter 2016of 2020 as compared to $1,001,000$0.7 million in the thirdfirst quarter of 2017.2019. Cost of sales in the thirdfirst quarter of 2017 included a charge2019 consisted primarily of $498,000 for unabsorbed production costs and a credit of $275,000 for the partial reversal of a reserve for slow moving inventory. Cost of sales in the third quarter of 2016 included a charge of $665,000 for unabsorbed production costs and approximately $1,044,000 to increase the reserve for slow moving inventory. Excluding these costs, cost of goods sold decreased by approximately $128,000, or 14%, from $906,000 in the third quarter of 2016 to $778,000 in the third quarter of 2017. The decrease in costs of goods sold, excluding the impact of unabsorbed production costs and inventory reserves, is consistent with the 14% decrease in implants from 14 in the third quarter of 2016 to 12 in the third quarter of 2017. For the next few quarters we expect that we will continue to keep our production levels low which will result in the generation of significant unabsorbed production costs.  We also expect that we will continue to reverse our reserve for excess inventory, as we sell our existing supply of Argus II systems, which will offset the cost of products that we ship.implanted and unabsorbed production costs.

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Research and development expense.Research and development expense increased by $238,000,$1.7 million, or 15%78%, to $1,826,000$3.9 million in the thirdfirst quarter of 2017 as compared to $1,588,0002020 from $2.2 million in the thirdfirst quarter of 2016. These expense amounts include $107,000 of offsetting grant revenue in2019. The costs increased from the third quarter of 2017 and $713,000 of offsetting grant revenue in the third quarter of 2016. Excluding the impact of grant revenues,prior period due primarily to costs incurred for internally produced prototypes. We expect our research and development expense decreased by $368,000, or 16%, from $2,301,000expenses to decrease significantly in the third quarter of 2016short-run related to $1,933,000our reduction in the third quarter of 2017. This decrease from the prior year is primarily attributable to $63,000 of higher people-related costs, including compensation, benefitsforce and travel, offset in part by $387,000 of lower costs for supplies and product prototypes. Whilesignificantly curtailed activity while we expect research andreevaluate our development expense to remain fairly constant for the remainder of the year, we expect that research and development costs will increase in future periods as we continue to enhance our current products and develop new products.  plans.

Clinical and regulatory expense.Clinical and regulatory expense increased $20,000,decreased $0.1 million, or 3%9%, from $609,000to $0.9 million in the thirdfirst quarter of 2016 to $629,0002020 from $1.0 million in the thirdfirst quarter of 2017.2019. This decrease is attributable to decreased costs associated with the Orion feasibility study. We expect clinical and regulatory costs to increasecontinue in the future at a reduced level as (i) we increaseresume activities for our implant run rateEarly Feasibility Study and enroll more patients in post-market clinical studiesreevaluate our development plans for regulatory authorities, and (ii) we conduct new clinical trials to assess new products such as the Orion I, test further enhancements to our existing product, and begin new trials for better sighted patients.Orion.

Selling and marketing expense.Selling and marketing expense increased $113,000,decreased $1.4 million, or 5%67%, from $2,262,000to $0.7 million in the thirdfirst quarter of 2016 to $2,375,0002020 from $2.1 million in the thirdfirst quarter of 2017.2019. This increasedecrease in costs was primarily the result of $326,000 more in people related costs, including salaries, benefits, stock based compensation, travel and commissions partially offsetdriven by $248,000 in lower costs for consultantsour reduced commercial activities related to items such as customer outreach programsArgus II and marketing strategies in the U.S.resulting decreased use of outside services, supplies, reduced headcount and foreign markets. While we expect these costs to increase in the future as we increase our selling and marketing resources to accelerate the commercialization of our product, werelated compensation expense. We expect selling and marketing expense to decrease over time when expressed as a percentage of product revenue.we no longer market Argus II and are focused on Orion development.

General and administrative expense. expense. General and administrative expense decreased $77,000,$0.4 million, or 3%17%, from $2,605,000to $2.0 million in the thirdfirst quarter of 2016 to $2,528,0002020 from $2.4 million in the third quartersame period of 2017.2019. This decrease is primarily attributable to decreases in patentlower compensation costs business insurance and bad debt expense offset, partially, by increases in people costs and outside legal expense. While we expect these costsprimarily due to increase in the future, wereduced staffing. We expect general and administrative expenseexpenses to decrease over time when expressed as a percentage of product revenue.related to our staffing reductions.

 

ComparisonRestructuring charges. We recorded a non-cash restructuring charge of the Nine Months Ended September 30, 2017 and 2016

Net Sales.Our net sales increased from $3,270,000$2.4 million in the first nine monthsquarter of 20162019 to $4,855,000 in the first nine months of 2017, an increase of $1,585,000, or 48%. This increase in net sales was due to an increase in the number of implants to 45 in the first nine months of 2017 compared to 35 in the first nine months of 2016 coupled with a higher average revenue per implant.

In the first nine months of 2017 implant volume in the North American market increased from 10 to 24 units. This increase was driven mainly by the U.S. where we had 19 implants in the first nine months of 2017 compared to nine implants in the first nine months of 2016, as our Centers of Excellence strategy continued to gain momentum. In Europe, the Middle East and Asia, we saw implant volume decrease slightly from 25 units in first nine months of 2016 to 21 units in the first nine months of 2017.

In the first nine months of 2017, revenue recognized per implant of $108,000 was compared to $93,000 in first nine months of 2016. The higher revenue per implant is due mainly to (i) a higher mix of implants in the North America and Asia where the prices tend to be higher, and the (ii) the higher U.S. Medicare reimbursement level in 2017 compared to 2016. We expect our average revenue per implant for the remainder of 2017 to be in a range of $100,000 to $120,000, depending on the geographic mix of implants. In 2018, with the lower CMS rate discussed above, we expect that our average revenue per implant will be in the range of $90,000 to $105,000, depending on the geographic mix of implants.

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Cost of sales.Cost of sales decreased by approximately $3,513,000, or 52%, from $6,768,000 in the first nine months of 2016 to $3,255,000 in the first nine months of 2017.  Cost of sales in the first nine months of 2017 included charges of $2,027,000 for unabsorbed production costs and a benefit of approximately $1.7 million for the partial reversal of a reserve for slow moving inventory. Cost of sales in the first nine months of 2016 included charges of $2,099,000 for unabsorbed production costs and approximately $2.6 million to increase the reserve for slow moving inventory. Excluding these costs, cost of goods sold increased by approximately $901,000 or 44%, from $2,058,000 in the first nine months of 2016 to $2,959,000 in the first nine months of 2017. This increase in costs of goods sold, excluding the impact of unabsorbed production costs and inventory reserves, compares to the 29% increase in implants from 35 in the first nine months of 2016 to 45 in the first nine months of 2017. For the next few quarters we expect that we will continue to keep our production levels low which will result in the generation of significant unabsorbed production costs.  We also expect that we will continue to reverse our reserve for excess and obsolete inventory as we sellin connection with our existing supply ofplans to suspend Argus II systems, which will offset the costproduction.  We recorded non-cash restructuring charges of products that we ship. 

Research and development expense.Research and development expense, net of grant revenue, increased by $2,356,000, or 72%, from $3,266,000$1.1 million in the first nine monthsquarter of 20162020 comprised of $0.4 million to $5,622,000fully reserve our inventory in connection with our decision to no longer market Argus II and $0.7 million to write-down our fixed assets that are not directly involved in the first nine months of 2017. In the first nine months of 2017, we utilized $235,000 of grant funds to offset costs versus $1,985,000 of grant funds utilized in the first nine months of 2016. Excluding this grant revenue offset, there was an increase in research and development expense of $606,000, or 12%, from $5,251,000 in the first nine months of 2016 to $5,857,000 in the first nine months of 2017. This increase is primarily the result of increased expenditures of $582,000 for compensation costs and $339,000 for outside services, including consultants, partially offset by $389,000 of lower costs for supplies and product prototypes. We expect to see research and development costs remain at the 2017, or higher, levels as we continue to invest in improvements to our Argus II product and development of our new Orion cortical implant.

Clinical and regulatory expense.Clinical and regulatory expense decreased by $28,000, or 1%, from $1,955,000a $0.2 million cash charge for severance compensation all of which was settled in the first nine months of 2016 to $1,927,000 in the nine months of 2017. We expect clinical and regulatory costs to increase in upcoming quarters as we (i) conduct clinical trials to assess new products such as the Orion cortical implant, (ii) test enhancements to our existing products, (iii) continue to assess the safety and efficacy of our current product for treating blindness due to age related macular degeneration, and (iv) conduct clinical trials to determine whether better-sighted patients would benefit from our current product.May 2020.

Selling and marketing expense.Selling and marketing expense increased by $584,000, or 9%, from $6,473,000 in the first nine months of 2016 to $7,057,000 in the first nine months of 2017. This increase was primarily due to $823,000 in higher people related costs in 2017 as compared to 2016, including higher salaries, stock based compensation, travel and commissions, offset in part by $250,000 less spent out outside services for items such as customer outreach and reimbursement consultants. While we expect these costs to increase in the future as we increase our selling and marketing resources to accelerate the commercialization of our product, we expect selling and marketing expense to decrease over time when expressed as a percentage of product revenue.

General and administrative expense.General and administrative expense increased by $535,000, or 7%, from $7,635,000 in the first nine months of 2016 to $8,170,000 in the first nine months of 2017. This increase is primarily attributable to $488,000 of higher personnel costs in 2017 and $478,000 more for outside services, including legal and consulting costs, partially offset by a $317,000 decrease in bad debt expense.  

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Liquidity and Capital Resources

Our consolidated financial statements have been presented on the basis ofthat our beingbusiness is a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We are subject to the risks and uncertainties associated with a business with no revenue that is developing a novel medical device, including limitations on our operating capital resources and uncertain demand for our products. We have experiencedincurred recurring operating losses and negative operating cash flows since inception, and have financedwe expect to continue to incur operating losses and negative operating cash flows for the foreseeable future. 

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In a rights offering completed on February 22, 2019, we sold approximately 5,976,000 units, each priced at $5.792 for net cash proceeds of approximately $34.4 million. Each unit consisted of one share and one immediately exercisable warrant having an exercise price of $11.76 per share. Entities controlled by Gregg Williams, our Chairman of the Board of Directors, acquired approximately 5,180,000 units in the offering for an aggregate investment of approximately $30 million. The expiration date of the warrants issued pursuant to this rights offering is March 14, 2024, and the expiration date of all previously outstanding warrants listed for trading under the symbol “EYESW” were extended to March 14, 2024.

On May 5, 2020, we closed our underwritten public offering of 7,500,000 shares of common stock at an offering price of $1.00 per share for aggregate net proceeds of approximately $6.6 million. We believe the financing provides sufficient working capital requirementsto sustain approximately six months of ongoing operations.

We do not have sufficient funds to support our operations for the next 12 months from the date of issuance of this report. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. Conducting clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete and we may never generate the necessary data or results required to obtain marketing approval. We do not expect revenues until we are successful in completing the development and obtaining marketing approval for Orion. We expect expenses to increase in connection with our ongoing activities, particularly as we continue clinical trials of Orion, initiate new research and development projects and seek marketing approval for any product candidates that we successfully develop. In addition, if we obtain marketing approval for Orion, we expect to incur significant additional expenses related to sales, marketing, distribution and other commercial infrastructure to commercialize such product. In addition, our product candidates, if approved, may not achieve commercial success. We incur significant costs associated with operating as a public company in a regulated industry.

Until such time, if ever, we can generate substantial product revenues, we anticipate that we will seek to fund our operations through public or private equity or debt financings, grants, collaborations, strategic partnerships or other sources. Accordingly, these factors among others raise substantial doubt about our ability to continue as a going concern. However, we may be unable to raise additional capital or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the recurring sale of equity, convertible debt or other equity-linked securities, the ownership interests of some or all of our common stockholders will be diluted, the holders of new equity securities in both publicmay have priority rights over our existing stockholders and private offerings. Asthe terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If adequate funds are not available, we may be required to further curtail operations significantly or to obtain funds by entering into agreements on unattractive terms. If, for example, we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us. Our inability to raise capital could have a result,material adverse effect on our business, financial condition and results of operations. Our independent registered public accounting firm, in its report on our 20162019 consolidated financial statements, has raised substantial doubt about our ability to continue as a going concern (see “Going Concern” above). In March 2017, the Company successfully completed a Rights Offering to existing shareholders, raising proceeds of $19.7 million net of cash offering costs, and selling 13.7 million Units at $1.47 per Unit. Each Unit consisted of a share of common stock and a five-year warrant with an exercise price of $1.47. Based upon this funding, management believes it has sufficient funds to through the first quarter of 2018. In order to continue business operations past that point, we will need to raise additional debt and/or equity capital. However, there can be no assurances that we will be able to secure any such additional financing on acceptable terms and conditions, or at all. If cash resources become insufficient to satisfy our ongoing cash requirements, then we would be required to scale back or discontinue our technology and product development programs and/or clinical trials, or obtain funds, if available (although there can be no certainty), through strategic alliances that may require us to relinquish rights to our products, or to discontinue our operations entirely.

concern.

Cash and money market funds increasedcash equivalents decreased by $2.4$9.0 million or 22%, from $10.9$11.3 million atas of December 31, 20162019 to $13.3$2.3 million at September 30, 2017.as of March 31, 2020. Working capital was $11.6a deficit of $1.6 million at September 30, 2017,as of March 31, 2020, as compared to $9.6$6.2 million atas of December 31, 2016, an increase2019, a decrease of $2.0 million, or 21%.$7.8 million. We use our cash money market fundsand cash equivalents and working capital to fund our operating activities. 

Cash Flows from Operating Activities

During the first ninethree months of 2017,2020, we used $17.2$8.7 million of cash in operating activities, consisting primarily of a net loss of $21.1$8.9 million, offset by non-cash charges which provided cash of $1.5 million for depreciation and amortization of property and equipment, stock-based compensation, excess inventory reserve, bad debt recoverychange in right of use assets, impairment charge and common stock issuable and increasedoffset by a net change in operating assets and liabilities of $2.4$1.3 million. During the first ninethree months of 2016,2019, we used $18.1$7.2 million of cash in operating activities, consisting primarily of a net loss of $22.8$9.7 million, offset by non-cash charges which provided cash of $5.9$3.4 million for depreciation and amortization of property and equipment, stock-based compensation, bad debt expense, excess inventory reserves and common stock issuable, and decreasedchange in right of use assets offset by a net change in operating assets and liabilities of $1.2$0.9 million.

Cash Flows from Investing Activities

DuringCash used for investing activities in the first ninethree months of 2017, investing activities used $2.5 million2020 was $331,000 and was $37,000 in the first three months of cash, reflecting $2.3 million used by the purchase of money market investments and $0.2 million used2019 both for the purchase of equipment. This compares to the first nine months of 2016 when investing activities used $2.2 million, reflecting $1.8 million used by the purchase of money market investmentsproperty and $0.4 million used for the purchase of equipment.

Cash Flows from Financing Activities

DuringFinancing activities used $5,000 of cash in the first ninethree months of 2017, finance activities provided $19.9 million2020 consisting of cash,$6,000 of which $19.7 million wasnet proceeds from the Rights Offering and $0.2 million was from employeesale of common stock plan purchases.offset by the use of $11,000 for the repurchase of partial shares in connection with our reverse stock split. Financing activities provided $20.3$34.4 million of cash in the first ninethree months of 2016,2019 consisting of which $19.5 million was provided by a Rights Offering and $0.8 millionthe net proceeds from the exercisesale of common stock options and employee stock plan purchases.

warrants.

Off-Balance Sheet Arrangements

We doAt March 31, 2020, we did not have any transactions, obligations or relationships that constitute off-balance sheet arrangements.

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Item 3.

Quantitative and QualitativeQualitative Disclosures about Market Risk

Interest Rate Sensitivity

The primary objective of our investment activities is to maintain the safety of principal and preserve liquidity without incurring significant risk. We invest cash in excess of our current needs in money market funds. As of September 30, 2017,March 31, 2020, our investments consisted solely of money market funds.

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Exchange Rate Sensitivity

During the nine months ended September 30, 2017, approximately 69% of our revenue was denominated in U.S. dollars, 27% in Euros, and 4% in Canadian dollars. In the same time period theThe majority of our operating expenses were denominated in U.S. dollars. We have not entered into foreign currency forward contracts to hedge our operating expense exposure to foreign currencies, but we may do so in the future. 

Item 4.

Controls and Procedures

Evaluation of Disclosure Controls and Procedures 

Our management, including our Acting Chief Executive Officer (“CEO”) and our Chief Financial Officer (“CFO”), evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2017.March 31, 2020. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. As of September 30, 2017,March 31, 2020, based on the evaluation of these disclosure controls and procedures, our CEO and in light of the material weaknesses found in our internal controls over financial reporting, our Chief Executive Officer and Chief Financial OfficerCFO have concluded that our disclosure controls and procedures were not effective.

Remediation Plan 

As of September 30, 2017, there were control deficiencies which constituted material weaknesses in our internal control over financial reporting. Management has taken, and is taking steps to strengthen our internal control over financial reporting. Specifically:

Control over Financial Reporting. The Company does not have complete written documentation of its internal control policies, procedures and controls and has not fully completed its testing of its key controls. Management evaluatedeffective at the impact of its failure to have fully tested its internal controls and procedures and has concluded that the control deficiency that resulted represented a material weakness and that our internal control over financial reporting was not effective as of the end of the period covered by this Quarterly Report on Form 10-Q. We will continue to work on completing the documentation and testing of our internal controls. 

Updating of Standard Costs. It is a customary practice for manufacturing companies to update their standard costs on a regular basis (at least annually) to ensure that inventory costs are accurately and properly stated.  During 2016, due to (i) the limited levels of production during the year, and (ii) the fact the Company had established reserves against approximately 61% of the cost of year-end inventory, which reserved for the cost of nearly all of the goods manufactured in 2016, the Company did not update its standard costs during fiscal 2016. The Company is currently reviewing it standard costs and expects to adjust its current standard costs before the end of 2017. The impact to the financial statements, taken as a whole, that would result from such an adjustment is expected to be immaterial.

While we have taken certain actions to address the material weaknesses identified, additional measures may be necessary as we work to improve the overall effectiveness of our internal controls over financial reporting. Through the actions in the remediation plan reported in our Annual Report on Form 10-K for the year ended December 31, 2016 and in our Quarterly Report on Form 10-Q for the period ended September 30, 2017, we believe that we are addressing the deficiencies that affected our internal control over financial reporting for the year and period then ended however we have not completed all of the corrective processes and procedures as contemplated herein for the identified material weaknesses. Until the remediation plan is fully implemented and operating for a sufficient period of time, we will not be able to conclude that the material weaknesses have been remediated. We will continue to monitor and assess our remediation activities to address the material weaknesses discussed above through remediation as soon as practicable and to provide reasonable assurance that they will prevent or detect material error in the financial statements.level. 

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Changes in Internal Control over Financial Reporting   

Other than changes that haveThere has been enacted pursuant to our remediation plan, there were no changeschange in our internal control over financial reporting during the quarter ended September 30, 2017March 31, 2020 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. We are updating our internal control environment to address changes in our risks in financial reporting to accommodate our reductions in operating activities, reductions in staffing levels, and segregation of duties. Such changes may result in new or reduced controls.

Inherent Limitations on Effectiveness of Controls

Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

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PART II-OTHER INFORMATION

Item 1.

Legal Proceedings

Twenty-oneTen oppositions have been filed by a third-partyPixium Vision are pending in the European Patent Office, each challenging the validity of a European patent owned or exclusively licensed by us.  We have filed one opposition that is currently pending in the Company.European Patent Office challenging the validity of a patent owned by Pixium Vision. The outcome of the challenges isare not certain, however, if successful, they may affect the Company’sour ability to block competitors from utilizing some of itsour patented technology in Europe. Management of the Company believes thattechnology. We believe a successful challenge or challenges will not have a material effect on the Company’sour ability to manufacture and sell itsour products, or otherwise have a material effect on the Company’sour operations.

By letter received June 23, 2020 counsel for a participant in the Orion Early Feasibility Study has alleged claims against the Company for breach of contract, breach of the implied covenant of good faith and fair dealing, negligent misrepresentation, promissory estoppel and negligent infliction of emotional distress. Counsel in addition has alleged that Second Sight has violated the protocol established by the FDA for good clinical practice within this industry. As full compensation for damages arising from these claims the Company was presented with a demand for payment of $3,000,000. The Company is partybelieves that the claims asserted are without merit. The Company will seek to litigation arisingdeter the filing of this claim. However, these claims are in the ordinaryearly stage and no assurance can be given that this matter will not result in litigation. To the extent a lawsuit is filed, the Company intends to vigorously defend it.

From time to time, we may be involved in a variety of legal proceedings and claims relating to securities laws, product liability, patent infringement, contract disputes, employment matters and other matters relating to various claims that arise in the normal course of business. our business in addition to governmental and other regulatory investigations and proceedings. It is management’sour opinion that the outcome of such matters will not have a material adverse effect on our results of operations, however, the Company’s financial statements.results of litigation, proceedings, disputes and claims are inherently unpredictable. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

 

Item 1A.

Risk Factors

 

We incorporate herein by referenceInvesting in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below, together with all of the other information in this Quarterly Report, including our financial statements and related notes, which could have a material adverse effect on our business, financial condition, results of operations and prospects. The risks described below are not the only risks facing us. Risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially affect our business, financial condition, results of operations and prospects. In addition, the impact of COVID-19 and any worsening of the economic environment may exacerbate the risks described below, any of which could have a material impact on us. This situation is changing rapidly and additional impacts may arise that we are not aware of currently.

In addition to other information set forth in this report, you should carefully consider the risk factors discussed under the “Risk Factors” section included in our 2019 Annual Report on Form 10-K, which was filed with the SEC on March 19, 2020 and as amended on Form 10-K/A and filed with the SEC on April 28, 2020, as well as those risk factors contained in our prospectus supplement dated April 30, 2020 as filed with the SEC on May 1, 2020. The information presented below updates, and should be read in conjunction with, the risk factors and information disclosed in our Form 10-K and our prospectus supplement. 

Since we have a limited operating history and have no current revenue producing operations, it is difficult to evaluate the future of our business.  

To date, our operations on a consolidated basis have consisted of the continued development and clinical studies of our Orion-focused technologies and implementation of the early parts of our business plan. We have incurred significant operating losses in each year since our inception and we will continue to incur additional losses for the next several years. In addition, our losses may be greater than expected and our operating results may suffer. We have limited historical financial data upon which we may base our projected revenue and base our planned operating expenses. Our limited operating history makes it difficult to evaluate our technology or prospective operations and business prospects. 

Despite promising results from the Early Feasibility Study for Orion being conducted at UCLA and Baylor we currently have no commercial products or product revenue and may never become profitable. 

To date, we have not generated profit from sales of our now discontinued Argus II product and will not generate revenues until we complete the development and attain the marketing approval for Orion. We have relied principally on financing from the sale of equity securities and the receipt of government and other grants to fund our operations. We expect that our future financial results will depend primarily on our success in further developing the Orion, conducting FDA approved clinical trials and obtaining clearance or approval for, launching, selling and supporting our Orion technology. To establish these operations we expect a need  to expend significant resources on hiring of personnel, continued scientific and product research and development, potential product testing and pre-clinical and clinical investigation, intellectual property development and prosecution, marketing and promotion, capital expenditures, working capital, general and administrative expenses, and fees and expenses associated with our capital raising efforts. We expect to incur costs and expenses related to consulting costs, laboratory development costs, hiring of scientists, engineers, sales representatives and other

28


operational personnel, and the continued development of relationships with potential partners as we continue to seek regulatory clearance or approval for our products. We are incurring significant operating losses, we expect to continue to incur additional losses for at least the next several years, and we cannot assure you that we will generate revenue or be profitable in the future. Our future or updated Orion products may never be cleared or approved or become commercially viable or accepted for use.

Investment in medical device technology is highly speculative, because it entails substantial upfront capital expenditures and significant risk that any potential product will fail to demonstrate adequate efficacy, clinical utility or acceptance by physicians and blind individuals. Investors should evaluate an investment in us in light of the uncertainties encountered by developing medical technology companies in a competitive environment. There can be no assurance that our efforts will be successful or that we will ultimately be able to achieve profitability. Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable could adversely affect the market price of our common stock and could significantly impair our ability to raise capital, expand our business or continue to implement our business plan.

There is substantial doubt about our ability to continue as a going concern.

To date, we have not generated any profit from our now discontinued Argus II product and we have incurred significant operating losses in each year since our inception and we anticipate continuing to incur additional losses for the next several years. In connection with our Annual Report on Form 10-K for the year ended December 31, 2019, management concluded that there is substantial doubt we can continue as an ongoing business for the next twelve months from the date that our audited consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2019 were issued unless we obtain additional capital. As a result, our independent registered public accountants included an explanatory paragraph in their auditors’ report relating to going concern.   

In May 2020 we sold 7.5 million shares of common stock at $1.00 per share to raise gross proceeds of $7.5 million in a registered public offering of securities. We plan to raise additional capital to fund our operations. No assurance can be given that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to us. Accordingly, management cannot conclude that such plans will be effectively implemented within the twelve months from the date that our unaudited condensed consolidated interim financial statements included in our Quarterly Report on Form 10-Q for the three months ended March 31, 2020 were issued.  

These factors, combined with our forecast of cash required to fund operations for a period of at least twelve months from the date that unaudited condensed consolidated interim financial statements included in our Quarterly Report on Form 10-Q for the three months ended March 31, 2020 were issued, raise substantial doubt about our ability to continue as a going concern.  

If we are unable to obtain sufficient funding, we may be unable to execute our business plan and fund operations. We may not be able to obtain additional financing on commercially reasonable terms, or at all. 

We have experienced operating losses, and we may continue to incur operating losses for the next several years as we implement our business plan. Currently, we have no revenue and do not have arrangements in place for all the anticipated financing that would be required to fully implement our business plan. Our prior losses combined with expected future losses, have had and will continue to have, for the foreseeable future, an adverse effect on our stockholders’ equity and working capital.

We will need to raise additional capital in order to continue to execute our business plan in the future however there is no assurance that we  will be successful, or that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to us. If we are unable to raise sufficient additional funds, we will need to further scale back our operations. The ongoing COVID-19 pandemic and resulting negative impact on the global macroeconomic environment and capital markets may make it more difficult for us to raise additional funds.

We cannot give any assurance that we will be able to obtain all the necessary funding that we may need. In addition, we believe that we will require additional capital in the future to fully develop our technologies and planned products to the stage of FDA approvals and a commercial launch. We have pursued and may pursue additional funding through various financing sources, including the private sale of our equity and debt securities, licensing fees for our technology, joint ventures with capital partners and project type financing. If we raise funds by issuing equity or equity-linked securities, dilution to some or all our stockholders will result. Any equity securities issued may also provide for rights, preferences, or privileges senior to those of holders of our common stock. The terms of debt securities issued or borrowings could impose significant restrictions on our operations. We also may seek government-based financing, such as development and research grants. There can be no assurance that funds will be available on commercially reasonable terms, if at all.

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The incurrence of indebtedness or the issuance of certain equity securities could result in increased fixed payment obligations and could also result in restrictive covenants, such as limitations on our ability to incur additional debt or issue additional equity, limitations on our ability to acquire or license intellectual property rights, and other operating restrictions that could adversely affect our ability to conduct our business. In addition, the issuance of additional equity securities by us, or the possibility of such issuance, may cause the market price of our common stock to decline. In the event that we enter into collaborations or licensing arrangements to raise capital, we may be required to accept unfavorable terms. These agreements may require that we relinquish, or license to a third party on unfavorable terms, our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves, or reserve certain opportunities for future potential arrangements when we might otherwise be able to achieve more favorable terms. In addition, we may be forced to work with a partner on one or more of our products or market development programs, which could lower the economic value of those programs to us.

If we filedare unable to obtain adequate financing or financing on terms satisfactory to us when we require it, we may terminate or delay the development of one or more of our Orion features updated products, delay clinical trials necessary to market our products, or delay establishment of sales and marketing capabilities or other activities necessary to commercialize our products. If this were to occur, our ability to grow and support our business and to respond to market challenges could be significantly limited or we may be unable to continue operations, in which case you could lose your entire investment.

Our business may be adversely affected by health epidemics including the recent coronavirus outbreak.

In December 2019, an outbreak of a novel strain of coronavirus (COVID-19) originated in Wuhan, China and has since spread globally. On March 11, 2020, the World Health Organization characterized COVID-19 as a pandemic. In addition, most states in the U.S., including California, where we are headquartered, have declared a state of emergency.  The pandemic has resulted in government authorities implementing numerous measures to try to contain the virus, such as travel bans and restrictions, quarantines, shelter-in-place or stay-at-home orders, and business shutdowns.

In accordance with local and state guidelines regarding the COVID-19 pandemic, we are requiring all of our employees to work remotely unless they cannot perform their essential functions remotely, and have also suspended all non-essential travel for our employees. While a significant number of our employees may be accustomed to working remotely or working with other remote employees, much of our workforce has not historically been remote. Although we continue to monitor the situation and may adjust our current policies as more information and public health guidance becomes available, temporarily suspending travel and restricting the ability to do business in person may create operational or other challenges, any of which could harm our business, financial condition and results of operations.

In addition, our clinical trials may be affected by the COVID-19 outbreak. Patient visits in ongoing clinical trials may be delayed, for example, due to prioritization of hospital resources toward the COVID-19 outbreak, travel restrictions imposed by governments, and the inability to access sites for initiation and monitoring. For example, scheduled patient visits to our clinical sites at UCLA and Baylor were temporarily put on hold due to COVID-19 and we are in the process of planning to resume patient visits with the Securitiessites. In addition, the validation study for the revised FLORA assessment was paused due to travel requirements for its completion. Also, some of our suppliers of certain materials used in the development of our product candidates are located in areas impacted by COVID-19 which could limit our ability to obtain sufficient materials for our product candidates. COVID-19 has and Exchange Commissionwill continue to adversely affect global economies and financial markets of many countries, resulting in an economic downturn that could affect demand for our product candidates, if approved, and impact our operating results. Even after the COVID-19 pandemic has subsided, we may continue to experience an adverse impact to our business as a result of the continued global economic impact of the pandemic. We could experience further harm to our business and we cannot anticipate all of the ways in which health epidemics such as COVID-19 could adversely impact our business. Although we are continuing to monitor and assess the effects of the COVID-19 pandemic on March 16, 2017.our business, the ultimate impact of the COVID-19 outbreak or a similar health epidemic is highly uncertain and subject to change.

 

COVID-19 has directly and indirectly adversely affected Second Sight and will likely continue to do so for an uncertain period of time. In March and April 2020 we laid off a substantial majority of our employees as a result of COVID-19 and an inability to obtain financing. We retain approximately 10 of our employees to oversee current operations.  The cumulative effects of COVID-19 on the Company cannot be predicted at this time, but could include, without limitation:

inability to meet warranty obligations for our Argus II products;

reputational damages of the Company and its products;

inability to raise additional funds to finance and continue our operations;

inability to maintain adequate office laboratory facilities;

inability to retain and hire experienced personnel;

30


inability to finalize our plan for and enroll patients into our proposed pivotal clinical  trial;

material delays or inability to complete development and commercialization of Orion;

inability to satisfy Nasdaq’s continued listing requirements and possible delisting; and

other uncertain events that may have negative impact effect on our operations.    

Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

Clinical testing is expensive and can take several or more years to complete, and its outcome is inherently uncertain. Failure or delay can occur at any time during the clinical trial process. Success in nonclinical studies and early feasibility clinical studies does not ensure that expanded clinical trials that will be used to support regulatory submissions will be successful. These setbacks may be caused by, among other things, nonclinical findings made while clinical trials were underway, and safety or efficacy observations made in clinical trials, including previously unreported adverse events. Even if our clinical trials are completed, the results may not be sufficient to obtain regulatory approval or clearance for our product candidates. 

Interim “top-line” and preliminary results from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publish interim top-line or preliminary results from our clinical trials. Interim results from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or top-line results also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available. Differences between preliminary or interim data and final data could significantly harm our business prospects and may cause the trading price of our common stock to fluctuate significantly.

Our efforts may never demonstrate the feasibility of our Orion technology

Our research and development efforts remain subject to all of the risks associated with the development of new technology. Our Orion technology, though based on our FDA approved Argus II is not yet fully developed. Development of the underlying technology, including the further development and refinement of our Orion technology, may be affected by unanticipated technical or other problems, among other development and research issues, and the possible insufficiency of funds needed in order to complete development of these products or devices. Regulatory and clinical hurdles or challenges also may result in delays and cause us to incur additional expenses that may increase our need for capital and result in additional losses. If we cannot complete, or if we experience significant delays in developing our technology, applications or products for use by those patients who can benefit from vision restoration, particularly after incurring significant expenditures, our business may fail and investors may lose the entirety of their investment.

We may not become commercially viable if our ultimate commercialized products or related treatments fail to obtain an adequate level of reimbursement by Medicare and other third-party payers. 

Although we were able to obtain adequate third party-payer reimbursement for our Argus II system, we believe that the commercial viability of our potential devices and products and related implant and post-implant treatments, and therefore our commercial success as a company, will be affected materially by the availability of government reimbursement and medical insurance coverage and reimbursement for newly approved medical therapies, technologies and devices. Insurance coverage and reimbursement are not assured. It typically takes a period of use in the marketplace before coverage and reimbursement are permanently established, if they are granted at all. In the U.S. and other jurisdictions in Europe and other regions, physicians and other healthcare providers generally rely on insurance coverage and reimbursement for their revenues, therefore this is an important factor in the overall commercialization plans of a proposed product and whether it will be accepted for use in the marketplace. We expect our products to be priced at levels not generally affordable by patients directly and therefore without insurance coverage and reimbursement for our planned products, we would expect to attain limited revenues, if any.

31


Medicare, Medicaid, health maintenance organizations and other third-party payers are increasingly attempting to contain healthcare costs by limiting both the scope of coverage and the level of reimbursement of new medical technologies and products, and as a result, they may not cover or provide adequate payment for the use of our planned Orion products. In order to obtain satisfactory reimbursement arrangements, we may have to agree to reduce the fee or sales price to one lower than initially planned. Each plan may separately require us to provide scientific and clinical support for the use of our products and, as a result, the coverage determination process is often a time-consuming and costly process with no assurance that coverage and adequate reimbursement will be applied consistently or obtained at all. Even if Medicare and other third-party payers decide to cover treatments involving our proposed devices and products, we cannot be certain that the reimbursement levels will be adequate. Accordingly, even if our planned products are approved for commercial sale, unless government and other third-party payers provide adequate coverage and reimbursement for our devices and products, some physicians and their patients may be discouraged from using them, and our sales would suffer.

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

None

Not applicable.

Item 3.

Defaults upon Senior Securities

None.

Not applicable.

Item 4.

Mine Safety Disclosures

Not applicable.

27 

Item 5.

Other Information

None.

On June 20, 2017, Thomas B. Miller, Chief Financial Officer of the Company, notified the Company that he was submitting his resignation as Chief Financial Officer to pursue other opportunities. Mr. Miller agreed to remain in his current role during a transition period. Mr. Miller’s departure did not result from a disagreement with the Company on any matter relating to the Company’s operations, policies or practices.32


Item 6.Item 6.

Exhibits

EXHIBIT INDEX

 

Exhibit

No.

Exhibit Description

3.1

Restated Articles of Incorporation of the Registrant. (1)

3.2

31.1

Amended and Restated Bylaws of the Registrant, as currently in effect. (1)
31.1

Certification of Principal Executive Officer of Second Sight Medical Products, Inc. pursuant to Section 302 of Sarbanes-Oxley Act of 2002.*

31.2

31.2

Certification of Principal Financial and Accounting Officer of Second Sight Medical Products, Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*

32.1

32.1

Certifications of Principal Executive Officer and Principal Financial and Accounting Officer of Second Sight Medical Products, Inc.  pursuant to Rule 13a-14(b) under the Exchange Act and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*

101.INS

101.INS

XBRL Instant Document.*

101.SCH

101.SCH

XBRL Taxonomy Extension Schema Document.*

101.CAL

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document.*

101.DEF

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document.*

101.LAB

101.LAB

XBRL Taxonomy Extension Label Linkbase Document.*

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document.*

 

*Included herein.

(1) Incorporated by reference to the registrant’s registration statement on Form S-1, file no. 333-198073, originally filed with the Securities and Exchange Commission on August 12, 2014, as amended.

28 

*

Included herein.

33


SIGNATURES

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.

 

Name

Title

Date

/s/  Jonathan Will McGuireMatthew Pfeffer

Acting Chief Executive Officer and Director

November 3,2017

June 26, 2020

 Jonathan Will McGuire

 Matthew Pfeffer

(Principal Executive Officer)

/s/  JThomas B. Millerohn T. Blake

Chief Financial Officer

November 3,2017

June 26, 2020

Thomas B. Miller

John T. Blake

(Principal Financial and Accounting Officer)

 

29 

34