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, 2023

OR

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 SightVivani Medical, Products, Inc.

(Exact name of Registrant as specified in its charter)

 

California02-0692322
(State or other jurisdiction of

incorporation or organization)

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

 

12744 San Fernando Road, 5858 Horton Street, Suite 400, Sylmar, 280Emeryville, CA 9134294608 

(Address of principal executive offices, including zip code)


(
415) 506-8462

(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 StockVANINASDAQ

 

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 filerAccelerated 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

 

As of November 3, 2017,May 10, 2023, the issuerregistrant had 56,806,35250,793,799 shares of common stock, issuedno par value per share and 7,680,938 warrants, outstanding.

 

 

 

 

 

SECOND SIGHTVIVANI MEDICAL, PRODUCTS, INC.

AND SUBSIDIARYSUBSIDIARIES

 

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

INDEX

TABLE OF CONTENTS

 

PART IFINANCIAL INFORMATION  
    
Item 1.Financial Statements (unaudited)
Condensed Consolidated Balance Sheets as of September 30, 2017 (Unaudited) and December 31, 2016

3

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

4

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

5

Condensed Consolidated Statements of Stockholders’ Equity for the nine months ended September 30, 2017 and 2016 (Unaudited)

6

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2017 and 2016 (Unaudited)

7

Notes to Condensed Consolidated Financial Statements8
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations17
Item 3.Quantitative and Qualitative Disclosures About Market Risk25
Item 4.Controls and Procedures26
Part IIOTHER INFORMATION  
    
Item 1.Legal ProceedingsCondensed Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022 273
Item 1A.Risk FactorsCondensed Consolidated Statements of Operations for the three months ended March 31, 2023 and 2022 274
Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2023 and 20225
Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three-month periods ended March 31, 2023 and 20226
Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2023 and 20227
Notes to Condensed Consolidated Financial Statements8
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations17
Item 3.Quantitative and Qualitative Disclosures About Market Risk22
Item 4.Controls and Procedures22
PART IIOTHER INFORMATION
Item 1.Legal Proceedings23
Item 1A.Risk Factors23
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds 2723
Item 3.Defaults Upon Senior Securities 27
Item 4.Mine Safety Disclosures27
Item 5.Other Information28
Item 6.Exhibits2823
 Signatures 29
Item 4.Mine Safety Disclosures23
Item 5.Other Information23
Item 6.Exhibits24
SIGNATURES25

 

 

 

SECOND SIGHTPART I. FINANCIAL STATEMENTS

Item 1. Financial Statements

VIVANI MEDICAL, PRODUCTS, INC.

AND SUBSIDIARYSUBSIDIARIES

 

Condensed Consolidated Balance Sheets (unaudited)

(Inin thousands)

 

 September 30, December 31,  March 31, December 31, 
 2017  2016  2023  2022 
 (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 
Cash and cash equivalents $38,073  $45,076 
Prepaid expenses and other current assets  462   717   2,611   2,452 
        
Total current assets  17,719   15,282   40,684   47,528 
        
Property and equipment, net  1,327   1,489   1,111   1,182 
Right-of-use assets  1,148   779 
Restricted cash  1,366   1,366 
Deposits and other assets  35   39   271   275 
        
Total assets $19,081  $16,810  $44,580  $51,130 
        
LIABILITIES AND STOCKHOLDERS’ EQUITY        
LIABILITIE S AND STOCKHOLDERS’ EQUITY        
Current liabilities:                
Accounts payable $826  $1,156  $746  $1,177 
Accrued expenses  2,330   2,088   2,114   2,358 
Litigation accrual  1,675   1,675 
Accrued compensation expense  2,266   1,600   415   657 
Accrued clinical trial expenses  623   629 
Deferred revenue  64   85 
Deferred grant revenue     104 
        
Current operating lease liabilities  913   955 
Total current liabilities  6,109   5,662   5,863   6,822 
        
Commitments and contingencies        
        
Long term operating lease liabilities  349    
Total liabilities  6,212   6,822 
Commitments and contingencies (Note 10)        
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 
Common stock, no par value; 300,000 shares authorized; shares issued and outstanding: 50,789 as of March 31, 2023 and 50,736 as of December 31, 2022, respectively  109,050   109,050 
Additional paid-in capital  39,559   30,697   8,378   8,009 
Notes receivable to finance stock option exercises     (2)
Accumulated other comprehensive loss  (572)  (608)  44   35 
Accumulated deficit  (226,968)  (205,861)  (79,104)  (72,786)
        
Total stockholders’ equity  12,972   11,148   38,368   44,308 
        
Total liabilities and stockholders’ equity $19,081  $16,810  $44,580  $51,130 

 

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


VIVANI MEDICAL, INC.

AND SUBSIDIARIES

 

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  Three Months Ended
March 31,
 
          2023 2022 
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  $3,955  $2,679 
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 
General and administrative, net of grants  2,646   1,228 
Total operating expenses  7,358   7,064   22,776   19,329   6,601   3,907 
                        
Loss from operations  (6,749)  (8,499)  (21,176)  (22,827)  (6,601)  (3,907)
Interest income  33   10   69   18 
Other income (expense), net  283   (17)
                        
Net loss $(6,716) $(8,489) $(21,107) $(22,809) $(6,318) $(3,924)
                        
Net loss per common share – basic and diluted $(0.12) $(0.20) $(0.40) $(0.57) $(0.12) $(0.11)
                        
Weighted average common shares outstanding – basic and diluted  56,799   42,220   53,206   39,929   50,755   36,806 

 

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

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Statements of Comprehensive Loss (Unaudited)

(In 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.


VIVANI MEDICAL, INC.

AND SUBSIDIARIES

 

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)Comprehensive Loss (unaudited)
(in thousands)

(In thousands)

         
  

Three Months Ended 

March 31,

 
  2023  2022 
Net loss $(6,318) $(3,924)
         
Other comprehensive loss:        
Foreign currency translation adjustments  9    
Comprehensive loss $(6,309) $(3,924)

 

Nine months ended September 30, 2017 and 2016

  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.


VIVANI MEDICAL, INC.

AND SUBSIDIARIES

 

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Statements of Cash Flows (Unaudited)Stockholders’ Equity (Deficit) (unaudited)
(in thousands)

(In thousands)

           Accumulated       
        Additional  Other     Total 
  Common Stock  Paid-in  Comprehensive  Accumulated  Stockholders’ 
  Shares  Amount  Capital  Loss  Deficit  Equity (Deficit) 
Balance, January 1, 2022 36,803  $54,649  $6,713  $       $(58,897) $2,465 
Repurchase of common stock  4                
Options exercised  24   1            1 
Stock-based compensation expense        340         340 
Net loss              (3,924)  (3,924)
                         
Balance, March 31, 2022  36,831  $54,650  $7,053  $ $(62,821) $(1,118)

 

  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 
           Accumulated       
        Additional  Other     Total 
  Common Stock  Paid-in  Comprehensive  Accumulated  Stockholders’ 
  Shares  Amount  Capital  Loss  Deficit  Equity 
Balance, January 1, 2023 50,736  $109,050  $8,009  $35  $(72,786) $44,308 
Options exercised  53                     
Stock-based compensation expense        369         369 
Foreign currency adjustment           9      9 
Net loss              (6,318)  (6,318)
                         
Balance, March 31, 2023  50,789  $109,050  $8,378  $44  $(79,104) $38,368 

 

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


VIVANI MEDICAL, INC.

AND SUBSIDIARIES

 

Condensed Consolidated Statements of Cash Flows

(in thousands)

 

         
  Three Months Ended March 31, 
  2023  2022 
  (unaudited) 
Cash flows from operating activities:        
Net loss $(6,318) $(3,924)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  108   83 
Stock-based compensation  369   340 
Non-cash lease expense  (62)  27 
Changes in operating assets and liabilities:        
Prepaid expenses and other assets  (153)  (61)
Accounts payable  (429)  192 
Accrued compensation expenses  (243)   
Accrued expenses  (238)  167 
Net cash used in operating activities  (6,966)  (3,176)
Cash flows from investing activities:        
Purchases of property and equipment  (37)  (30)
Net cash used in investing activities  (37)  (30)
Cash flows from financing activities:        
Proceeds from SAFE note     8,000 
Net proceeds from sale of common stock and exercise of warrants     1 
Net cash provided by financing activities     8,001 
Effect of exchange rate changes on cash and cash equivalents      
Cash, cash equivalents and restricted cash:        
Net increase (decrease)  (7,003)  4,795 
Balance at beginning of period  46,442   2,178 
Balance at end of period $39,439  $6,973 
Non-cash investing and financing activities:        
Establishment of operating right-of-use assets through operating lease obligations $668  $ 

 

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


VIVANI MEDICAL, PRODUCTS, INC.

AND SUBSIDIARY

Notes to Condensed Consolidated Financial Statements (Unaudited)(unaudited)

1.Organization and Business Operations

Vivani Medical, Inc. (“Vivani,” the “Company,” “we,” “us,” “our” or similar terms) is a preclinical stage biopharmaceutical company which develops miniaturized, subdermal implants utilizing its proprietary NanoPortal™ technology to enable long-term, near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop and potentially commercialize drug implant candidates, alone or in collaboration with pharmaceutical company partners to address a leading cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence. For example, approximately 50% of patients treated for type 2 diabetes are non-adherent to their medicines which can lead to poor clinical outcomes. We are developing a portfolio of miniature, sub-dermal drug implant candidates that, unlike most oral and injectable medicines, are designed with the goal of guaranteeing adherence by delivering therapeutic drug levels for up to 6 months or the life of the implant. In addition, by leveraging our proprietary NanoPortal implant technology we can design implants that deliver minimally fluctuating drug levels that may improve the tolerability profiles for certain medicines for which side effects are associated with fluctuating drug levels such as GLP-1 receptor agonists (GLP-1s).

 

ThreeIn February 2022, we announced the signing of a definitive merger agreement between Nano Precision Medical, Inc. (“NPM”) and Nine Months Ended September 30, 2017 and 2016

1. Organization and Business Operations

Second Sight Medical Products, Inc. (“Second Sight” or “the Company”), formerlypursuant to which NPM became a wholly-owned subsidiary of Second Sight. On August 30, 2022, the merger closed and the combined company of Nano Precision Medical (“NPM” and Second Sight LLC,Medical Products (“SSMP)” was founded in 1998 as a limited liabilityrenamed Vivani Medical, Inc,

While the primary focus of Vivani is to develop and ultimately commercialize the drug implant business from legacy company NPM, Vivani’s new management team remains committed to identifying and was subsequently incorporated inexploring strategic options for the Statefurther advancement of California in 2003.the neuromodulation business of former legacy company Second Sight develops, manufactureswhich includes development of its pioneering neurostimulation systems to help patients recover critical body functions. On December 28, 2022, the neuromodulation assets and markets implantable prosthetic devices that can restore some functional visioncertain of its liabilities were contributed to patients blindedCortigent, Inc. a newly formed wholly owned subsidiary of Vivani, in exchange for 20 million shares of common stock of Cortigent. In March 2023, Vivani announced the filing of a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (“SEC”) for the proposed initial public offering of Cortigent. Cortigent is expected to continue to be majority-owned by outer retinal degenerations, such as Retinitis Pigmentosa.Vivani immediately following the initial public offering.

 

In 2007,Subject to completion of Cortigent’s initial public offering, Vivani intends to focus exclusively on further development of the drug implant business. Vivani plans to file an Investigational New Drug (IND) application with the US Food and Drug Administration to support a first in human (FIH) study with lead asset NPM-119 (GLP-1 implant). Following an acceptable IND submission, Vivani plans to initiate the FIH study, named LIBERATE-1, which is a Randomized, Phase 2, 12-week investigation of NPM-119 in patients with type 2 diabetes. The IND filing and the initiation of LIBERATE-1 remain on track to occur mid-2023.


Agreement and Plan of Merger with Nano Precision Medical, Inc.

On February 4, 2022, Second Sight formed Medical Products, Inc. (“Second Sight (Switzerland) Sarl, initially to manage clinical trials for its products in Europe,Sight”) entered into an agreement and later to manage sales and marketing in Europe, the Middle East and Asia. As the lawsplan of Switzerland require at least two corporate stockholders, Second Sight (Switzerland) Sarl is 99.5% owned directlymerger (the “Merger Agreement”) with Nano Precision Medical, Inc. (“NPM”). The Merger was approved by the Company and 0.5% is owned by an executiveshareholders of Second Sight who is acting as a nomineeon July 27, 2022, and closed on August 30, 2022. Upon consummation of the Company. Accordingly,Merger, NPM became a wholly-owned subsidiary of Second Sight. Concurrent with to the Merger, Second Sight (Switzerland) Sarl is considered 100% owned for financial statement purposeschanged its name to Vivani Medical, Inc. and is consolidated withchanged its trading symbol from EYES to VANI, and trades under the ticker VANI on the NASDAQ market. Certain investors and members of the NPM board of directors are also investors and members of the board of directors of Second Sight for all periods presented.Sight.

 

Since its inception,Under the Company has generated limited revenues fromterms and conditions of the saleMerger Agreement, the securities of productsNPM converted into the right to receive shares of Second Sight’s common stock representing 77.32% of the total issued and has financed its operations primarily through the issuanceoutstanding shares of common stock of Second Sight on a fully converted basis, including, without limitation, giving effect to the conversion of all options, warrants, and any and all other convertible debt (which has been converted into common stock), and grants primarily from government agencies.securities assuming net settlement. Second Sight filed a Registration Statement on Form S-4 on May 13, 2022, in connection with the Merger to register the merger shares effective June 24, 2022.

 

On March 6, 2017,February 4, 2022, in connection with the CompanyMerger, Second Sight and NPM also entered into a Simple Agreement for Future Equity (“SAFE”) whereby Second Sight provided to NPM an investment advance of $8 million. The Merger Agreement provided that the SAFE would terminate if the Merger were to be successfully completedcompleted. Under the terms of the SAFE, upon successfully completion of the Merger on August 30, 2022, the investment advance was eliminated. Under the accounting for a registered Rights Offeringbusiness combination, the $8 million adjusted the purchase consideration.

The Merger involved a change of control and was accounted for as a reverse merger in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Under this method of accounting, Second Sight was treated as the “acquired” company for financial reporting purposes with NPM as the acquirer. The assets acquired and liabilities assumed by NPM were recorded at fair value under Accounting Codification Standard (“ASC 805”), Business Combinations. Accordingly, on August 30, 2022 (the “Acquisition Date”), NPM (a calendar year-end entity) was deemed to existing stockholders raising net proceedshave acquired 100% of approximately $19.7the outstanding common shares and voting interest of Second Sight, Medical, Inc. The results of Second Sight’s operations have been included in the consolidated financial statements since that date.

The acquisition-date fair value of consideration transferred totaled $54.4 million in, which it sold 13.7 million Units at $1.47consisted of the fair value of the 13,136 common shares deemed issued to Second Sight shareholders, was determined based on the per Unit, which was theshare closing price of the Company’s common stockshares on that date. Each Unit consistedthe acquisition date of a share$4.14.

The following table summarizes the fair values of the Company’s common stockassets acquired and a warrant to purchase an additional share ofliabilities assumed at 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 theacquisition 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 per 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.(in thousands):

At August 30, 2022   
    
Cash $55,374 
Property and equipment  99 
Prepaid expenses  1,657 
Right of use assets  140 
Other assets  56 
Total identifiable assets acquired  57,326 
Current liabilities  (3,913)
Right of use liabilities  (151)
Total liabilities assumed  4,064 
Net identifiable assets acquired $53,262 

 

The Company evaluatedSAFE loan of $8.0 million was cancelled in the financial impactMerger which adjusted the fair value of FASB ASC 260, “Earnings per Share,” which states, among other things, that if a rights issue is offered to all existing stockholders at an exercise price that is less thannet assets acquired.

The following table summarizes the calculation of the gain on bargain purchase (in thousands): 

     
Total consideration $54,385 
SAFE loan forgiven  (8,000)
Less net identifiable assets acquired  (53,262)
Gain on bargain purchase $6,877 

Because NPM purchased 100% of Second Sight and the fair value of identifiable assets acquired and liabilities assumed exceeded the fair value of the stock, thenconsideration, we reassessed the weighted average shares outstandingrecognition and basicmeasurement of identifiable assets acquired and diluted earnings per share shall be adjusted retroactively to reflect the bonus element of the rights offering forliabilities assumed and concluded that all periods presented. The Company determinedacquired assets and assumed liabilities were properly recognized and that the applicationvaluation procedures and resulting measures were appropriate. As a result, we recognized a gain of this specific provision of ASC 260 was immaterial to previously issued financial statements and, therefore, did not retroactively adjust previously reported weighted average shares outstanding and basic and diluted earnings per share.$6.9 million.

 

We recognized $0.7 million of acquisition related costs that were expensed in the twelve months ended December 31, 2022. These costs are included in the consolidated income statement in the line item entitled “General and administrative costs.”

 

Pro forma consolidated net loss as if Second Sight had been included in the consolidated results was $6.1 million for the three months ended March 31, 2022.

Liquidity

From inception, our operations have been funded primarily through the sales of our common stock and warrants. The Company’scompletion of our reverse merger with Second Sight Medical Products, Inc. provided $53.3 million in net assets including approximately $55.4 million in cash.

Our 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 novel medical devices, 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 least the next several years as a result of which, management has concludedforeseeable future. We estimate that there is substantial doubt about the Company’s ability to continue as a going concern. The Company’s independent registered public accounting firm, in its report on the Company’s 2016 consolidated financial statements, has also raised substantial doubt about the Company’s ability to continue as a going concern.

The Company believes that it hascurrently available cash will provide 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 requireenable the Company to relinquish rights tomeet its products, or to discontinue its operations entirely. planned obligations into the second half of 2024.

 


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 and accompanying notes for the fiscal year ended December 31, 2022, included in the Company’swithin our Annual Report on Form 10-K forfiled with the year ended DecemberSEC on March 31, 2016. Operating2023. 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.

 

Significant Accounting PoliciesIncome taxes - interim periods

In calculating the provision for interim income taxes, in accordance with ASC 740, Income Taxes, an estimated annual effective tax rate is applied to year-to-date ordinary income. At the end of each interim period, we estimate the effective tax rate expected to be applicable for the full fiscal year. This differs from the method utilized at the end of an annual period.

Use of estimates

 

The Company’spreparation of financial statements requires management to make a number of estimates and assumptions related to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the period. Estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. Some of the more significant estimates include the purchase price of net assets acquired in the Merger, useful lives of long-lived assets, the fair value of equity-based compensation and evaluation of going concern. Actual results could differ materially from those estimates.

Net income/loss per share

Basic net income/loss per share is computed using net income/loss from operations divided by the weighted-average number of shares of common stock outstanding during the period.

Diluted net income/loss per share represents net income/loss from operations divided by the weighted- average number of common shares outstanding during the period, including all potentially dilutive common stock equivalents. Common stock equivalents consist of shares subject to warrants and share-based awards with exercise prices less than the average market price of common stock for the period, to the extent their inclusion would be dilutive.

The computation of the weighted-average shares of common stock outstanding for diluted EPS excludes the following potential common shares as of March 31, 2023, and 2022 (in thousands):

Schedule of net loss per share

  March 31,
2023
  March 31,
2022
 
Shares underlying warrants outstanding  10,311  9,074 
Shares underlying stock options outstanding  6,055   4,583 

The shares underlying the SAFE obligation were issuable only if the Merger were to be terminated. These contingently issuable shares were excluded from the dilutive computation because conversion was not “probable” as defined in the accounting literature. However, if the evaluation met the probability threshold, the shares would be excluded from diluted EPS since their inclusion would have an anti-dilutive effect.

Significant Accounting Policies

Our significant accounting policies are set forth in Note 2 of theour financial statements in its Annual Report on Form 10-K for the year ended December 31, 2016.2022, included within our Annual Report on Form 10-K filed with the SEC on March 31, 2023.

 

Net Operating Loss CarryforwardsRecently Issued Accounting Pronouncements

 

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.  

Recent 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 and money market funds, and trade accounts receivable. The Company maintainsfunds. We 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 extends differing levels of credit to customers, and typically does not require collateral.

The Company also maintains a cash balance at a bank in Switzerland, which is insured up to an amount specified by the deposit insurance agency of Switzerland.

Customer Concentration

During the three and nine months ended September 30, 2017 and 2016, the following customers comprised more than 10% of 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

 
              
Customer 1   18%  0%  8%  0%
Customer 2   18%  0%  6%  4%
Customer 3   18%  0%  6%  0%
Customer 4   10%  0%  3%  0%
Customer 5   9%  0%  11%  0%
Customer 6   0%  21%  0%  8%
Customer 7   0%  12%  3%  3%
Customer 8   0%  11%  0%  16%
Customer 9   0%  0%  0%  10%

As of September 30, 2017 and December 31, 2016, the following customers comprised more than 10% of 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 

Geographic Concentration

During the three and nine months ended September 30, 2017 and 2016, regional revenue, based on customer locations which comprised more than 10% of 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

 
             
United States  72%  47%  59%  47%
Italy  9%  11%  11%  21%
Germany  5%  35%  3%  15%

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.we deem reputable.

 

Foreign Operations

 

The accompanying condensed consolidated financial statements as of September 30, 2017 (unaudited) and DecemberMarch 31, 20162023, include gross assets amounting to $2.0$0.1 million and $1.7 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’s operations.

 


4. Money Market FundsFair 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.

 

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 basednon-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 
             
September 30, 2017 (unaudited):                
Money market funds $12,705  $12,705  $   $ 
                 
December 31, 2016:                
Money market funds $10,336  $10,336  $  $ 

Schedule of Money Market Funds at their Level within the Fair Value Hierarchy

  Total  Level 1  Level 2  Level 3 
March 31, 2023 (unaudited):            
Money market funds $36,527  $36,527  $  $ 
December 31, 2022:                
Money market funds $44,417  $44,417  $  $ 


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 
  (Unaudited)     
Raw materials $390  $477 
Work in process  3,378   5,032 
Finished goods  3,123   3,284 
         
   6,891   8,793 
         
Allowance for excess and obsolescence  (3,646)  (5,377)
Inventories, net $3,245  $3,416 

 

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 
  (Unaudited)     
Laboratory equipment $2,398  $2,300 
Computer hardware and software  1,297   1,220 
Leasehold improvements  299   288 
Furniture, fixtures and equipment  46   45 
         
   4,040   3,853 
         
Accumulated depreciation and amortization  (2,713)  (2,364)
Property and equipment, net $1,327  $1,489 

 

12 
  March 31,
2023
  December 31,
2022
 
Equipment $3,557  $3,520 
Furniture and fixtures  10   10 
Software  51   51 
Leasehold improvements  12   12 
   3,630   3,593 
Accumulated depreciation and amortization  (2,519)  (2,411)
Property and equipment, net $1,111  $1,182 

6.   Equity Securities

 


Common Stock IssuableRight-of-use assets and operating lease liabilities

 

Non-employee membersWe 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 Boardrespective assets. The depreciable life of Directorsassets and leasehold improvements are paid for their services in common stock on June 1limited by the expected lease term. Our lease agreements do not contain any material residual value guarantees or restrictive covenants. As most of each yearour leases do not provide an implicit rate, we used our estimated incremental borrowing rate based on the average closing prices forinformation available at commencement date in determining the immediately preceding twenty trading days. Aspresent value of September 30, 2017, the Company accrued $86,000 for these services, which equates to 75,000 shares. These shares have not yet been issued and are excluded from the calculation of weighted average common shares outstanding for EPS purposes.lease payments.

 

Potentially Dilutive Common Stock EquivalentsOn February 1, 2023, we entered into a lease agreement, effective March 1, 2023, to sublease office space to replace Cortigent’s existing headquarters. Our rental payments amount to $22,158 per month plus operating expenses, to lease 14,823 square feet of office space at 27200 Tourney Road, Valencia, California 91355.The sub-lease has a term of two years and two months. We also entered into a lease for storage space on January 25, 2023, in the same building at a cost of $6,775 per month for a term of two years and one month. 

Schedule of right of use assets and operating lease liabilties

Assets Classification March 31,
2023 (in thousands)
  December 31,
2022 (in thousands)
 
Non-current assets Right-of-use assets $1,148  $779
Liabilities          
Current Current operating lease liabilities $913  $955 
Long term Long term operating lease liabilities $349  $ 

Schedule of lease liabilities

   For the three
months ended
March 31, 2023
  For the three
months ended
March 31, 2022
 
Cash paid for operating lease liabilities in thousands: $377  $221 

Rent expense, including common area maintenance charges, was $0.3 million and $0.2 million during the three-month periods ended March 31, 2023 and 2022, respectively.


6. Equity Securities

 

At September 30, 2017 and 2016, the Company excluded the outstanding securities summarized below, which entitle the holders thereofWe are authorized to ultimately acquireissue 300,000,000 shares of common stock with 50,788,799 issued as of March 31, 2023. In addition, we are authorized to issue 10,000,000 shares of preferred stock with none issued. On August 19, 2022, the Company initiated a reverse stock split of one share for every three shares. All share numbers have been retroactively adjusted for the split. On August 30, 2022, 13,136,362 shares were deemed issued for the merger acquisition.

7. Warrants

NPM, prior to the Merger, issued common stock and warrants (collectively, the “unit” or “units”) in 2019, 2020 and 2021 for $3.15 per unit. Outstanding warrants of 7,746,855 to purchase common stock are shown in the table below and generally expire 5 years from its calculationsthe date of earningsissuance at $3.15 per share, are transferable into one share of common stock and may be exercised on a cashless basis. The warrants qualified for an exception to derivative accounting and, accordingly, their value was not bifurcated from the total purchase price.

Second Sight warrants of 7,691,063 were outstanding and are convertible into 2,563,688 shares in the table below and converted as part of the Merger for Vivani warrants on a like for-like basis. The weighted average exercise price of these warrants is $35.24. Of this total 7,680,938 warrants are convertible into 2,560,313shares outstanding,and are tradeable on the open market. Under accounting standards in a business combination, these warrants were measured at fair value as their effect would have been anti-dilutive (in thousands), as follows (unaudited):of the Merger date; however, the warrants were substantially out-of-the-money and were assigned no value.

 

  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 

7. Warrants


A summary of warrant activity for the ninethree months ended September 30, 2017March 31, 2023 is presented below (in thousands, except per share and contractual life data) (unaudited).

 

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

Summary of Warrant Activity

  Number of
 Shares
  Weighted
Average
Exercise
Price
Per Share
  Weighted
Average
Remaining
Contractual
Life (in Years)
 
Warrants outstanding as of December 31, 2022  10,311  $11.13   2.31 
Issued           
Exercised           
Forfeited or expired           
Warrants outstanding as of March 31, 2023  10,311  $11.13   2.06 
Warrants exercisable as of March 31, 2023  10,311  $11.13   2.06 

 

The intrinsic value of warrants outstanding at September 30, 2017 was $0.as of March 31, 2023, had no intrinsic value.

 

13 

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 for the ninethree months ended September 30, 2017March 31, 2023, is presented below (in thousands, except per share and contractual life data) (unaudited).

 

  Number  Weighted Average  Weighted Average Remaining Contractual 
  of Shares  Exercise Price  Life (in Years) 
Options outstanding at December 31, 2016  3,667  $7.23   6.27 
Granted  2,504  $1.85     
Exercised          
Forfeited or expired  (641) $5.58     
             
Options outstanding at September 30, 2017  5,530  $4.98   7.56 
             
Options exercisable at September 30, 2017  2,090  $7.15   5.36 

Summary of Stock Option Activity

  Number of
Shares
  Weighted
Average
Exercise
Price
Per Share
  Weighted
Average
Remaining
Contractual
Life (in Years)
 
Options outstanding as of December 31, 2022  5,272  $3.07   7.15 
Granted  993  $1.22     
Exercised  (91) $0.43     
Forfeited or expired  (119) $2.93     
Options outstanding, vested and expected to vest as of March 31, 2023  6,055  $2.81   7.26 
Options exercisable as of March 31, 2023  3,784  $3.30   6.16 

 

The estimated aggregate intrinsic value of stock options exercisable at September 30, 2017as of March 31, 2023, was $0.$0.2 million. As of September 30, 2017,March 31, 2023, there was $5.7$2.9 million of total unrecognized compensation cost related to outstanding stock options that will be recognized over a weighted average period of 2.911.4 years.

 

During the nine monthsquarter ended September 30, 2017, the CompanyMarch 31, 2023, we granted stock options to purchase 2,464,150993,333 shares of common stock to certain employees.employees and board members. The options are exercisable for a period of ten years from the date of grant at prices ranging from $1.13 to $1.97a weighted average price of $0.90 per share, which was calculated at 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 ($0.55 to $0.96 per share). Assumptions used in$0.9 million using the model were anfollowing assumptions: expected term of 6.254.00 to 6.02 years, volatility of 48.0%100%, a risk-free interest rate of 1.92%4.22% to 2.14%4.45%, and an expected dividend rate of 0%.

In March 2017,0.0%.We also granted 402,500 RSU’s (as defined below) during the Company grantedquarter. These RSUs had market conditions which required our stock optionsprice to purchase 40,000 shares of common stock to an outside attorneyexceed $3.15 per share for three consecutive days 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 offor the date of grant. The fair value of these options, as calculated pursuantRSUs 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.

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.vest.

 

The following table summarizes Restricted Stock Unit (RSU)restricted stock unit (“RSU”) activity (unaudited) for the ninethree months ended September 30, 2017March 31, 2023 (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 

Summary of Restricted Stock Unit

  

Number

of Shares 

  

Weighted

Average Grant

Date Fair Value

Per Share 

 
Outstanding as of December 31, 2022    $ 
Awarded  403   0.93 
Vested and released      
Forfeited/canceled      
Outstanding as of March 31, 2023  403  $0.93 

 

As of September 30, 2017,March 31, 2023, there was $1.1$0.4 million of total unrecognized compensation cost related to the outstanding RSUs that will be recognized over a weighted average period of 1.883.1 years.

 


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, 2023, and 2016 is2022 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

 
                 
Cost of sales $36  $80  $184  $245 
Research and development  71   77   203   238 
Clinical and regulatory  42   43   135   136 
Selling and marketing  116   74   321   59 
General and administrative  641   624   1,978   1,903 
Total $906  $898  $2,821  $2,581 

Stock-based Compensation Expense

         
  Three Months Ended
March 31,
 
  2023  2022 
Research and development $248  $190 
General and administrative  121   150 
Total $369  $340 

 

9.  

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9.Risk and Uncertainties

We continue to monitor the ongoing COVID-19 global pandemic which has resulted in travel and other restrictions to reduce the spread of the disease. We presently are not experiencing any significant disruptions from the ongoing COVID-19 pandemic. All clinical and chemistry, manufacturing and control activities are currently active.

The safety, health and well-being of all patients, medical staff and internal and external teams is the paramount and primary focus. As the pandemic and its resulting restrictions evolve in jurisdictions across the country, the potential exists for further disruptions to projected timelines. We are in close communication with clinical teams and key vendors and are prepared to take action should the pandemic worsen and impact the business in the future.

10. Commitments and Contingencies

Clinical Trial Agreements

Based upon FDA approval of Argus II, which was obtained in February 2013, we were required to collect follow-up data from subjects enrolled in our pre-approval trial for a period of up to ten years post-implant, which was extended through the year 2019. This requirement to collect follow-up data was halted in 2020 with FDA approval. In addition, we conducted three post-market studies to comply with U.S. FDA, French, and European post-market surveillance regulations and requirements and are conducting an early feasibility clinical study of Orion. We have contracted with various universities, hospitals, and medical practices to provide these services. Payments are based on procedures performed for each subject and are charged to clinical and regulatory expense as incurred. Total amounts charged to expense for the three months ended March 31, 2023 were $26,000.

Lease Agreement

Vivani entered into a triple net lease agreement for a single building with 43,645 square feet of space in Alameda, California on November 21, 2022. The stated term of the lease commences on June 1, 2023 and terminates on September 30, 2033, ten years and 4 months. Payments increase annually from $2,676,311 to $3,596,784, or 124 payments less the first four which are abated, totaling approximately $31 million. Vivani will be responsible for insurance, property taxes and CAM charges. Vivani was required to deposit $1.4 million to guarantee a letter of credit to secure the lease and this amount is included in long-term assets on the balance sheet at March 31, 2023. The current lease expires on September 30, 2023.

Litigation, Claims and Assessments

 

Twenty-oneThree oppositions have been filed by a third-partyPixium Vision SA (“Pixium”) are pending in the European Patent Office, each challenging the validity of a European patent owned or exclusively licensed by the Company.us. The outcomeoutcomes 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 doestechnology. We do not believe that a successful challenge will have a material effect on the Company’sour ability to manufacture and sell itsour products, or otherwise have a material effect on our operations.

As described in the Company’s operations.

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10-K for the year ended December 31, 2020, the Company had entered into a Memorandum of Understanding (“MOU”) for a proposed business combination with Pixium. In response to a press release by Pixium dated March 24, 2021, and subsequent communications between us and Pixium, our Board of Directors determined that the business combination with Pixium was not in the best interest of our shareholders. On April 1, 2021, we gave notice to Pixium that we were terminating the MOU between the parties and seeking an amicable resolution of termination amounts that may be due, however no assurance can be given that an amicable resolution will be reached. We accrued $1,000,000 of liquidated damages as contemplated by the MOU in accounts payable as of March 31, 2021, and remitted that amount to Pixium in April 2021. Pixium indicated that it considered this termination wrongful, rejected the Company’s offers, but retained the $1,000,000 payment. On May 19, 2021, Pixium filed suit in the Paris Commercial Court, and currently claim damages of approximately €5.1 million or about $5.6 million. We believe we have fulfilled our obligations to Pixium with the liquidated damages payment of $1,000,000.On December 9, 2022, the Company received notice that the Paris Commercial Court has rendered its judgement, including finding that the Company’s termination of the MOU was not valid. In the judgement, the Company was ordered to pay to Pixium the amount of €2,500,000 minus a €947,780 credit for the $1,000,000 already paid for, a net amount payable of approximately €1,552,220. The Company ismay appeal the decision within three months from the date of service which was February 28, 2023. The Company recorded a charge of $1,675,000 for the year ended December 31, 2022, related to this matter but plans to raise any and all legal challenges to this preliminary judgement.

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.

16 

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

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 2016 financial statements and related notes included10-Q. Some of the information contained in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 16, 2017. In addition to historical information, thethis discussion and analysis hereor set forth elsewhere in this Quarterly Report, including information with respect to our products, plans and 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, and statements regarding the anticipated or projected impact of our merger on our business, results of operations, financial condition or prospects, 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 the forward-looking statements that we make. We assume no obligations to update these forward-looking statements as a result of certain factors, including, but not limited, to those set forth under “Risk Factors” in Part II, Item 1Areflect events or circumstances after the date of this report.Quarterly Report or to reflect actual outcomes.

Overview

 

Second Sight was founded in 1998 withVivani Medical, Inc. (“Vivani,” the “Company,” “we,” “us,” “our” or similar terms) is a missionpreclinical stage biopharmaceutical company which develops miniaturized, subdermal implants utilizing its proprietary NanoPortal™ technology to enable long-term, near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop manufacture, and market prosthetic devicespotentially commercialize drug implant candidates, alone or in collaboration with pharmaceutical company partners to address a leading cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence. For example, approximately 50% of patients treated for type 2 diabetes are non-adherent to their medicines which can lead to poor clinical outcomes. We are developing a portfolio of miniature, sub-dermal drug implant candidates that, restore some useful visionunlike most oral and injectable medicines, are designed with the goal of guaranteeing adherence by delivering therapeutic drug levels for up to blind individuals. Our principal offices6 months or the life of the implant. In addition, by leveraging our proprietary NanoPortal implant technology we can design implants that deliver minimally fluctuating drug levels that may improve the tolerability profiles for certain medicines for which side effects 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.associated with fluctuating drug levels such as GLP-1 receptor agonists (GLP-1s).

 

Our current product,In February 2022, we announced the Argus® II System, treats outer retinal degenerations, such as retinitis pigmentosa,signing of a definitive merger agreement between Nano Precision Medical, Inc. (“NPM”) and Second Sight Medical Products, Inc. (“Second Sight”), pursuant to which we referNPM became a wholly-owned subsidiary of Second Sight. On August 30, 2022, the merger closed and the combined company of Nano Precision Medical (“NPM” and Second Sight Medical Products (“SSMP)” was renamed Vivani Medical, Inc,

While the primary focus of Vivani is to as RP. RP is a hereditary disease, affecting an estimated 1.5 million people worldwide including about 100,000 people indevelop and ultimately commercialize the United States, that causes a progressive degenerationdrug implant business from legacy company NPM, Vivani’s new management team remains committed to identifying and exploring strategic options for the further advancement of the light-sensitive cellsneuromodulation business of former legacy company Second Sight which includes development of its pioneering neurostimulation systems to help patients recover critical body functions. On December 28, 2022, the neuromodulation assets and certain of its liabilities were contributed to Cortigent, Inc. a newly formed wholly owned subsidiary of Vivani, in exchange for 20 million shares of common stock of Cortigent. In March 2023, Vivani announced the filing of a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (“SEC”) for the proposed initial public offering of Cortigent. Cortigent is expected to continue to be majority-owned by Vivani immediately following the initial public offering.

Subject to completion of Cortigent’s initial public offering, Vivani intends to focus exclusively on further development of the retina, leadingdrug implant business. Vivani plans to significant visual impairment and ultimately blindness. The Argus II System isfile an Investigational New Drug (IND) application with the only retinal prosthesis approved in the United States by theUS Food and Drug Administration (FDA), and was to support a first in human (FIH) study with lead asset NPM-119 (GLP-1 implant). Following an acceptable IND submission, Vivani plans to initiate the first approved retinal prosthesis in the world. By providingFIH study, named LIBERATE-1, which is a useful formrandomized, Phase 2, 12-week investigation of artificial visionNPM-119 in patients who otherwise have total sight loss,with type 2 diabetes. The IND filing and the Argus II System can provide benefits which include:initiation of LIBERATE-1 remain on track to occur mid-2023.


Liquidity

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.

The Argus II System provides an artificial form of vision that differs from the vision of people with normal sight. It does not restore normal vision and it does not slow or reverse the progression of the disease. Results vary among patients and while the majority of patients receive a significant benefit from the Argus II, some patients report receiving little or no benefit.

Our major corporate, clinical and regulatory milestones include:

In 1998, Second Sight was founded.

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

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

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, and Taiwan, South Korea and Russia in 2017. With the exception of Taiwan and Russia, we have full regulatory approval to sell in these regions. In Taiwan and Russia we have limited regulatory approval but we are working to obtain full regulatory approval in both countries. We sell primarily through our direct sales force, but use distributors in certain countries.

17 

Going Concern

From inception, our operations have been funded primarily through the sales of our common stock as well asand warrants. The completion of our reverse merger with Second Sight Medical Products, Inc. provided $53.3 million in net assets including approximately $55.4 million in cash.

Second Sight was awarded a $6.4 million NIH five-year grant (with annual reviews) from the issuanceNational Institutes of convertible debt,Health (NIH) to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis”. The fifth and final year grant of $1.0 million was approved in March 2023.

We are subject to the risks and uncertainties associated with a business with no revenue that is developing novel pharmaceutical product candidates and medical devices candidates. 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. We expect our operating expenses to increase significantly as we continue our business operations, particularly as we prepare to and initiate our planned clinical trial of NPM-119 and conduct our other research and clinicaldevelopment activities. Our financial statements have been presented on the basis that our business is a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. To finance our operations, we will need to raise additional capital, which cannot be assured. Our operating plan may change as a result of many factors currently unknown to us, and we will need to seek additional funds 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 productemployee base or otherwise capitalize on our business opportunities, as desired, which could materially and adversely affect our business, financial condition and results of operations. We estimate that currently available cash will provide sufficient funds to enable the Company to meet its planned obligations into the second half of 2024.

Merger Agreement

As discussed in the Notes to Condensed Consolidated Financial Statements of the Company, on February 4, 2022, the Company entered the Merger Agreement. On May 13, 2022, the Company filed a Registration Statement on Form S-4 (the “Registration Statement”) with the SEC in connection with the contemplated Merger, which is currently effective. Shareholders of the Company approved the Merger on July 27, 2022, and the merger was completed in August 2022.

Safe Agreement

On February 4, 2022, in connection with the Merger, Second Sight and NPM also entered into a Simple Agreement for Future Equity (“SAFE”) whereby Second Sight provided to NPM an investment advance of $8 million. If the Merger were to be terminated without completion, NPM would issue to Second Sight that number of shares of NPM common stock equal to not less than 2.133% of the issued and outstanding shares of NPM common stock assuming exercise or conversion of all outstanding vested and unvested options, warrants, and convertible securities. The agreement provided that the SAFE would terminate if the Merger were to be successfully completed.

Under the terms of the SAFE, upon successfully completion of the Merger on August 30, 2022, the investment advance was eliminated. Under the accounting for a business combination, the $8 million adjusted the purchase consideration.

18

Critical Accounting Policies and Estimates

The preparation of our condensed consolidated financial statements in conformity with generally accepted accounting principles in the United States (“GAAP”) and the requirements of the United States Securities and Exchange Commission require management to make estimates, assumptions and judgments that affect the amounts, liabilities, revenue generatedand 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.

There have been no material changes to our critical accounting policies during the three months ended March 31, 2023.

Results of Operations

Operating Expenses. We generally recognize our operating expenses as incurred in two general operational categories: research and development and general and administrative. Our operating expenses also include a non-cash component related to the amortization of stock-based compensation for research and development and general and administrative personnel. We 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 reductions to operating expenses.

Research and development expenses consist primarily of employee compensation and consulting costs related to the design, development, and enhancements of our current and potential future products, and clinical as well as internal and external costs associated with conducting clinical trials and maintaining relationships with regulatory agencies offset by grant revenue received in support of specific research projects. We expense our research and development costs as they are incurred.

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.

Comparison of the Three Months Ended March 31, 2023 and 2022

Research and development expense. Research and development expense increased by $1.3 million, or 48%, to $4.0 million in the first quarter of 2023 from $2.7 million in the first quarter of 2022. The costs increased due to costs of our acquired company Second Sight being included from the merger acquisition date of August 30, 2022. This inclusion increased these costs for the quarter by $0.6 million. The remainder of the increase was primarily due to subdermal drug implants development costs.

General and administrative expense. General and administrative expense increased $1.4 million, or 115%, to $2.6 million in the first quarter of 2023 from $1.2 million in the same period of 2022. This increase is primarily attributable to increased costs associated with the inclusion of our acquired company Second Sight which totaled $1.1 million in the first quarter of 2023. Approximately $0.1 million of costs were incurred related to the Cortigent IPO in the quarter.

Other income. Other income was impacted by the salemerger acquisition of cash which increased our Argus II System. Duringinterest income for the years ended December 31, 2016 and 2015 and the ninethree months ended September 30, 2017, we funded our business primarily through:March 31, 2023 as compared to the same period in 2022 before the merger.

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.

Liquidity and Capital Resources

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 liabilities in the normal course of business. We are subject to the risks and uncertainties associated with a business with oneno revenue that is developing a novel pharmaceutical product linecandidates and limited commercial product revenues,medical device candidates, including limitations on our operating capital resources and uncertain demand for our products. 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 at least the next fewforeseeable future.

20

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 our products. We expect expenses to increase in connection with our ongoing activities, particularly as we initiate clinical trials, initiate new research and development projects and seek marketing approval for any product candidates that we successfully develop. In particular, we expect to incur increased expenses as we initiate our planned Phase 2 clinical trial of NPM-119, for which we plan to file an IND with the FDA. In addition, if we obtain marketing approval 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 result of which, management has concludedpublic company in a regulated industry.

Until such time, if ever, we can generate product revenues, we anticipate that there is substantial doubt about the Company’s abilitywe will seek to continue as a going concern. The Company’s independent registeredfund our operations through public accounting firm, in its report on the Company’s 2016 consolidated financial statements, has also raised substantial doubt about the Company’s 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 needor 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. To the extent that we raise additional capital through the sale of equity, convertible debt and/or equity capital. However, there can be no assurances thatother equity-linked securities, the Companyownership interests of some or all of our common stockholders will be ablediluted, the holders of new equity securities may have priority rights over our existing stockholders and the 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 secure anytake specific actions, such as incurring additional financing on acceptable terms and conditions,debt, making capital expenditures 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.declaring dividends. If cash resources become insufficient to satisfy the Company’s ongoing cash requirements, the Company wouldadequate funds are not available, we may be required to scale backcurtail operations significantly or discontinue its technology and product development programs and/or clinical trials, orto obtain funds if available (although there can be no certainty),by entering into agreements on unattractive terms. If, for example, we raise funds through additional collaborations, strategic alliances thator licensing arrangements with third parties, we may require the Companyhave 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.

18 

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. 

19 

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 that 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 further expand our market to include nearly all profoundly blind individuals, other than those who are blind due to preventable diseases or due to brain damage, by developing a visual cortical prosthesis. We refer to this product as the Orion I visual prosthesis system. We estimate that there are approximately 5.8 million people worldwide who are legally blind due to causes other than preventable conditions, RP or AMD. If approved for marketing, the FDA and other regulatory agencies will determine the subset of these patients who are eligible for the Orion I based on our clinical trial 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 vision. In October 2017, we received final IDE approval from the FDA to begin a human feasibility study of the Orion I visual prosthesis system. This study will confirm initial findings in our human pilot study we announced in the fourth quarter of 2016 and provide the first human data of a fully functional wireless visual cortical stimulator system including the external video camera system. We expect to implant and activate our Orion I visual prosthesis system in human subjects in late 2017. 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 expansion to a pivotal clinical trial in 2018.  

We began a five-subject pilot study in the United Kingdom in June 2015, to determine the utility of the Argus II System for use in persons suffering from dry AMD. In the second quarter of 2016 we completed enrollment and continue to track the subjects via the site in Manchester. The subjects have reported 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, the subjects have not demonstrated significant objective benefit over their residual vision when using the Argus II. We plan to continue testing these subjects and will submit a revised clinical protocol in 2017. Our approaches to improving 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 approval to test new retinal stimulation programs with the existing subjects with the belief they may benefit. If this clinical testing is successful, we plan to enroll additional patients in our pursuit of a solution for this large patient population.

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Critical Accounting Policies

The preparation of our condensed consolidated financial statements in conformity with generally accepted accounting principles in the United States, or GAAP, requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the notes to the financial statements. 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. There have been no material changes to our critical accounting policies during the nine months ended September 30, 2017.

Results of Operations

Net sales.Our net sales are derived primarily from the sale of our Argus II System. We began selling our products in Europe in 2011, Saudi Arabia in 2012, 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 commercialization of our product, as our product becomes more well-known and accepted in the market, and as insurance coverage becomes more widespread.

Cost of sales.Cost of sales includes the salaries, benefits, material, overhead, third party costs, warranty, charges for excess inventory, and other costs required to make our Argus II System at our Sylmar, California facility. In the second quarter of 2016, due to lower implant rates 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 the cost of goods shipped for revenue in the period. We expect to work through our slow-moving inventory and resume normal production when and if sales orders increase. Our ability to generate a gross profit in future periods will depend on our ability to (i) generate higher revenues and (ii) 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.

Operating Expenses.We generally recognize our operating expenses as we incur them 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 to research and development, clinical and regulatory, sales and marketing and general and administrative personnel. From time to time we have received grants from institutions or agencies, such as the National Institutes of Health, to help fund some of the cost of our development efforts. We have recorded these grants as offsets to the costs as they are incurred to complete the related work.

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 incurred. We expect research and development expenses to increase in the future as we pursue further enhancements of our existing product and develop technology for our potential future products, such as 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.

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. We expect clinical and regulatory expenses to increase as we assess the safety and efficacy of enhancements to our current Argus II System, seek to expand the indications for the Argus II System, such as AMD, 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 marketing expenses to increase as we hire additional sales personnel, initiate additional marketing programs, develop relationships with new distributors, and expand the number of medical centers that buy and implant our Argus II System and any future products.

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.

Comparison of the Three Months Ended September 30, 2017 and 2016

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.Net sales increased by $430,000, or 36%, from $1,180,000 in the third quarter of 2016 to $1,610,000 in the third 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.

Revenue recognized per implant was $134,000 in the third quarter of 2017 compared to $84,000 in the third quarter 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.

Cost of sales.Cost of sales decreased by approximately $1,614,000, or 62%, from $2,615,000 in the third quarter 2016 to $1,001,000 in the third quarter of 2017.  Cost of sales in the third quarter of 2017 included a charge 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.

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Research and development expense.Research and development expense increased by $238,000, or 15%, to $1,826,000 in the third quarter of 2017 as compared to $1,588,000 in the third quarter of 2016. These expense amounts include $107,000 of offsetting grant revenue in the third quarter of 2017 and $713,000 of offsetting grant revenue in the third quarter of 2016. Excluding the impact of grant revenues, research and development expense decreased by $368,000, or 16%, from $2,301,000 in the third quarter of 2016 to $1,933,000 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, benefits and travel, offset in part by $387,000 of lower costs for supplies and product prototypes. While we expect research and 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.  

Clinical and regulatory expense.Clinical and regulatory expense increased $20,000, or 3%, from $609,000 in the third quarter of 2016 to $629,000 in the third quarter of 2017. We expect clinical and regulatory costs to increase in the future as (i) we increase our implant run rate and enroll more patients in post-market clinical studies 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.

Selling and marketing expense.Selling and marketing expense increased $113,000, or 5%, from $2,262,000 in the third quarter of 2016 to $2,375,000 in the third quarter of 2017. This increase in costs was primarily the result of $326,000 more in people related costs, including salaries, benefits, stock based compensation, travel and commissions partially offset by $248,000 in lower costs for consultants related to items such as customer outreach programs and marketing strategies in the U.S. 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, 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 decreased $77,000, or 3%, from $2,605,000 in the third quarter of 2016 to $2,528,000 in the third quarter of 2017. This decrease is primarily attributable to decreases in patent costs, business insurance and bad debt expense offset, partially, by increases in people costs and outside legal expense. While we expect these costs to increase in the future, we expect general and administrative expense to decrease over time when expressed as a percentage of product revenue.

Comparison of the Nine Months Ended September 30, 2017 and 2016

Net Sales.Our net sales increased from $3,270,000 in the first nine months of 2016 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 inventory, as we sell our existing supply of Argus II systems, which will offset the cost 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 in the first nine months of 2016 to $5,622,000 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 $1,955,000 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.

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 of our being a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. We have experienced recurring operating losses and negative operating cash flows since inception, and have financed our working capital requirements through the recurring sale of our equity securities in both public and private offerings. As a result, our independent registered public accounting firm, in its report on our 2016 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 relinquishvaluable rights to our products,technologies, future revenue streams, research programs or product candidates, or to discontinuegrant licenses on terms that may not be favorable to us. Our inability to raise capital could have a material adverse effect on our operations entirely.business, financial condition and results of operations.

Cash, cash equivalents and money market funds increasedrestricted cash decreased by $2.4$7.0 million or 22%, from $10.9$46.4 million atas of December 31, 20162022 to $13.3$39.4 million at September 30, 2017.as of March 31, 2023. Working capital was $11.6$34.9 million at September 30, 2017, as of March 31, 2023 compared to $9.6$40.7 million atas of December 31, 2016, an increase2022, a decrease of $2.0 million, or 21%.$5.8 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,ended March 31, 2023, we used $17.2$7.0 million of cash in operating activities, consisting primarily of a net loss of $21.1$6.3 million and a net increase in net operating assets of $1.1 million, partially offset by non-cash charges of $1.5$0.4 million for depreciation and amortization of property and equipment, stock-based compensation excess inventory reserve, bad debt recovery and common stock issuable and increased by a net change in operating assets and liabilitiesright of $2.4 million.use assets. During the first ninethree months of 2016,ended March 31, 2022, we used $18.1$3.2 million of cash in operating activities, consisting primarily of a net loss of $22.8$3.9 million, offset by non-cash charges which provided cash of $5.9$0.4 million for depreciation and amortization of property and equipment, stock-based compensation, bad debt expense, excess inventory reserveschange in right of use and common stock issuable, and decreasedpartially offset by a net changedecrease in net operating assets and liabilities of $1.2$0.3 million.

Cash Flows from Investing Activities

During the first nine months of 2017,Cash used for investing activities used $2.5 million of cash, reflecting $2.3 million used byin the purchase of money market investmentsthree months ended March 31, 2023 and $0.2 million2022 was minimal for both periods. In 2023 $37,000 was used for the purchase of property and 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 investments and $0.4 millionIn 2022, $30,000 was used for the purchase of property and equipment.

Cash Flows from Financing Activities

DuringFinancing activities was zero in the first ninethree months of 2017, finance activities provided $19.9 million of cash, of which $19.7 million was from the Rights Offering and $0.2 million was from employee stock plan purchases.ended March 31, 2023. Financing activities provided $20.3$8.0 million of cash in first ninethe three months of 2016, of which $19.5 million was provided by a Rights Offering and $0.8 millionended March 31, 2022 from the exercisefunding of stock options and employee stock plan purchases.the SAFE agreement.

Off-Balance Sheet Arrangements

We doAs of March 31, 2023, we did not have any transactions, obligations or relationships that constitute off-balance sheet arrangements.

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Item 3.Quantitative and Qualitative 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, 2023, 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 Chief Executive Officer (“CEO”) and our Chief Financial Officer (“CFO”), evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2017.the end of the period covered by this report. 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, 2023, 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, 2023, 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 operating activities, 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.


PART II-OTHER INFORMATION

Item 1.Legal Proceedings

Twenty-oneThree oppositions have been filed by a third-partyPixium Vision SA (“Pixium”) are pending in the European Patent Office, each challenging the validity of a European patent owned or exclusively licensed by the Company.Second Sight. The outcomeoutcomes 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 our operations.

As described in the Company’s operations.

10-K for the year ended December 31, 2020, the Company had entered into a Memorandum of Understanding (“MOU”) for a proposed business combination with Pixium Vision SA (“Pixium”). In response to a press release by Pixium dated March 24, 2021, and subsequent communications between us and Pixium, our Board of Directors determined that the business combination with Pixium was not in the best interest of our shareholders. On April 1, 2021, we gave notice to Pixium that we were terminating the MOU between the parties and seeking an amicable resolution of termination amounts that may be due, however no assurance can be given that an amicable resolution will be reached. We accrued $1,000,000 of liquidated damages as contemplated by the MOU in accounts payable as of March 31, 2021 and remitted that amount to Pixium in April 2021. Pixium indicated that it considered this termination wrongful, rejected the Company’s offers, but retained the $1,000,000 payment. On May 19, 2021, Pixium filed suit in the Paris Commercial Court, and currently claim damages of approximately €5.1 million or about $5.6 million. We believe we have fulfilled our obligations to Pixium with the liquidated damages payment of $1,000,000. On December 9, 2022, the Company received notice that the Paris Commercial Court has rendered its judgement, including finding that the Company’s termination of the MOU was not valid. In the judgement, the Company was ordered to pay to Pixium the amount of €2,500,000 minus a €947,780 credit for the $1,000,000 already paid for, a net amount payable of approximately €1,552,220. The Company is partymay appeal the decision within three months from the date of service which was February 28, 2023. The Company recorded a charge of $1,675,000 for the year ended December 31, 2022 related to litigation arisingthis matter but plans to raise any and all legal challenges to this preliminary judgement.

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 ordinarynormal 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 referenceOur business is subject to numerous material and other risks. You should carefully consider the risks and uncertainties described below together with all of the other information contained in this Form 10-Q, including our consolidated financial statements and the related notes, and in our other filings with the SEC. If any of the stated risks actually occur, our business, prospects, operating results, and financial condition could suffer materially. In such event, the trading price of our common stock could decline and you might lose all or part of your investment. The material risks associated with our business were most recently discussed in our Form 10-K that we filed on March 31, 2023. There have been no material changes from the risk factors includedpreviously disclosed in our Annual Report on Form 10-K, which we filed with the Securities and Exchange Commission on March 16, 2017.such filing.

Item 2.Unregistered Sales of Equity Securities and Use of Proceeds

Not applicable.None.

Item 3.Defaults upon Senior Securities

Not applicable.None.

Item 4.Mine Safety Disclosures

Not applicable.

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Item 5.Other Information

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.None.


Item 6.Exhibits

EXHIBIT INDEX

Exhibit No.Exhibit Description

3.1Restated Articles of IncorporationIncorporation of the Registrant. (1)Registrant as amended (incorporated byreference to Exhibit 3.1 in the Company’s Registration Statement on Form S-1 filed with the SEC on September August 12,2014)

3.2Amendment to Restated Articles of Incorporation of the Registrant (incorporated byreference to Exhibit 3.2 in the Company’s Registration Statement on FormS-4 filed with the SEC on September May13,2022)

3.3Second Amendment to Restated Articles of Incorporation of the Registrant (incorporated byreference to Exhibit 3.1 in the Company’s Current Report on Form8-K filed with the SEC on January3, 2020)

3.4Certificate of Amendment,filed August 25,2022,and effective August 30,2022 changingthe name of the Companyto “Vivani Medical,Inc.” (incorporated by reference Exhibit 3.1 in the Company’s Current Report on Form 8-K filed with the SEC on September 2,2022)

3.5Amended and Restated BylawsBylaws of the Registrant, Registrant,as currently currentlyin effect. (1)effect (incorporated byreference to Exhibit 3.1 in the Company’s Registration Statement onForm S-1 filed with the SEC on September August 12,2014)

31.1Certification of Principal Executive Officer of Second SightVivani Medical, Products, Inc. pursuant to Section 302 of Sarbanes-Oxley Act of 2002.*

31.2Certification of Principal Financial and Accounting Officer of Second SightVivani Medical, Products, Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*

32.1Certifications of Principal Executive Officer and Principal Financial and Accounting Officer of Second SightVivani 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.INSXBRL Instant Document.*

101.SCHXBRL Taxonomy Extension Schema Document.*

101.CALXBRL Taxonomy Extension Calculation Linkbase Document.*

101.DEFXBRL Taxonomy Extension Definition Linkbase Document.*

101.LABXBRL Taxonomy Extension Label Linkbase Document.*

*101.PREIncluded herein.XBRL Taxonomy Extension Presentation Linkbase Document.*

(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 104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)*

*Indicates the exhibit is being furnished, not filed, with this report.


SIGNATURES

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report has beenreport to be signed belowon its behalf by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.undersigned thereunto duly authorized.

NameTitleDate
/s/ Jonathan Will McGuireAdam Mendelsohn Chief Executive Officer and DirectorNovember 3,2017May 15, 2023
 Jonathan Will McGuireAdam Mendelsohn(Principal Executive Officer)
/s/  Thomas B. MillerBrigid MakesChief Financial OfficerNovember 3,2017 May 15, 2023
Thomas B. MillerBrigid Makes(Principal Financial and Accounting Officer)

 

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