eyes-10q_20200630.htm

 

 

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 June 30, 2020

OR

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

For the transition period from ________ to ________

 

Commission File Number 001-36747

Second Sight Medical Products, Inc.

(Exact name of Registrant as specified in its charter)

 

California

 

02-0692322

(State or other jurisdiction of

incorporation or organization)

 

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

 

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

(Address of principal executive offices, including zip code)

 

(818) 833-5000

(Registrant’s telephone number, including area code)

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

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock

 

EYES

 

NASDAQ

Warrants

 

EYESW

 

NASDAQ

 

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

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes      No  

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

 

 Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

Smaller reporting company

Emerging growth company

 

 

 

 

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

 

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

 Yes    No 

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

 

As of August 10, 2020, the registrant had 23,118,233 shares of common stock, no par value per share and 7,682,244 warrants, outstanding.

 

 

 

 

 


 

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

 

FORM 10-Q

TABLE OF CONTENTS 

 

PART I

FINANCIAL INFORMATION

 

 

 

 

Item 1.

Financial Statements

 

 

 

 

 

Condensed Consolidated Balance Sheets as of June 30, 2020 (unaudited) and December 31, 2019

3

 

Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2020 and 2019 (unaudited)

4

 

Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2020 and 2019 (unaudited)

5

 

Condensed Consolidated Statements of Stockholders’ Equity (Deficiency) for each of the three-month periods ended during the six months ended June 30, 2020 and 2019 (unaudited)

6

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2020 and 2019 (unaudited)

7

 

 

 

Item 2.

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

20

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

28

 

 

 

Item 4.

Controls and Procedures

28

 

 

 

PART II

OTHER INFORMATION

 

 

 

 

Item 1.

Legal Proceedings

29

 

 

 

Item 1A.

Risk Factors

29

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

34

 

 

 

Item 3.

Defaults Upon Senior Securities

34

 

 

 

Item 4.

Mine Safety Disclosures

34

 

 

 

Item 5.

Other Information

34

 

 

 

Item 6.

Exhibits

35

 

 

 

SIGNATURES

36

 

2


 

Part I. Financial Statements

Item 1. Financial Statements

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Balance Sheets

(in thousands)

 

 

 

June 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

 

 

(unaudited)

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

3,505

 

 

$

11,327

 

Accounts receivable, net

 

 

 

 

 

455

 

Inventories, net

 

 

 

 

 

1,029

 

Assets held-for-sale

 

 

400

 

 

 

 

Prepaid expenses and other current assets

 

 

676

 

 

 

299

 

Total current assets

 

 

4,581

 

 

 

13,110

 

Property and equipment, net

 

 

212

 

 

 

1,122

 

Right-of-use assets

 

 

 

 

 

2,342

 

Deposits and other assets

 

 

12

 

 

 

25

 

Total assets

 

$

4,805

 

 

$

16,599

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

517

 

 

$

1,093

 

Accrued expenses

 

 

1,023

 

 

 

1,889

 

Accrued compensation expense

 

 

330

 

 

 

2,698

 

Accrued clinical trial expenses

 

 

517

 

 

 

707

 

Current operating lease liabilities

 

 

 

 

 

237

 

Contract liabilities

 

 

335

 

 

 

335

 

Total current liabilities

 

 

2,722

 

 

 

6,959

 

Long term operating lease liabilities

 

 

 

 

 

2,365

 

Total liabilities

 

 

2,722

 

 

 

9,324

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

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

   outstanding: 23,118 and 15,643 as of June 30, 2020 and December 31,

   2019, respectively

 

 

270,126

 

 

 

264,008

 

Additional paid-in capital

 

 

49,260

 

 

 

48,613

 

Accumulated other comprehensive loss

 

 

(533

)

 

 

(562

)

Accumulated deficit

 

 

(316,770

)

 

 

(304,784

)

Total stockholders’ equity

 

 

2,083

 

 

 

7,275

 

Total liabilities and stockholders’ equity

 

$

4,805

 

 

$

16,599

 

 

See accompanying notes.

3


 

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Statements of Operations (unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

Net sales

 

$

 

 

$

1,282

 

 

$

 

 

$

2,410

Cost of sales

 

 

 

 

 

933

 

 

 

 

 

 

1,664

Gross profit

 

 

 

 

 

349

 

 

 

 

 

 

746

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development, net of grants

 

 

323

 

 

 

3,436

 

 

 

4,210

 

 

 

5,619

Clinical and regulatory, net of grants

 

 

429

 

 

 

536

 

 

 

1,343

 

 

 

1,542

Selling and marketing

 

 

 

 

 

1,689

 

 

 

701

 

 

 

3,792

General and administrative

 

 

1,516

 

 

 

2,256

 

 

 

3,537

 

 

 

4,705

Restructuring charges

 

 

848

 

 

 

873

 

 

 

2,229

 

 

 

3,297

Total operating expenses

 

 

3,116

 

 

 

8,790

 

 

 

12,020

 

 

 

18,955

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(3,116

)

 

 

(8,441

)

 

 

(12,020

)

 

 

(18,209)

Interest income

 

 

16

 

 

 

1

 

 

 

34

 

 

 

69

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(3,100

)

 

$

(8,440

)

 

$

(11,986

)

 

$

(18,140)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per common share – basic and diluted

 

$

(0.15

)

 

$

(0.56

)

 

$

(0.67

)

 

$

(1.28)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding – basic and diluted

 

 

20,337

 

 

 

15,542

 

 

 

17,993

 

 

 

13,816

 

See accompanying notes.

4


 

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Statements of Comprehensive Loss (unaudited)

(in thousands)

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net loss

 

$

(3,100

)

 

$

(8,440

)

 

$

(11,986

)

 

$

(18,140

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

10

 

 

 

9

 

 

 

29

 

 

 

1

 

Comprehensive loss

 

$

(3,090

)

 

$

(8,431

)

 

$

(11,957

)

 

$

(18,139

)

 

See accompanying notes.

5


 

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

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

(in thousands)

 

 

 

 

Common Stock

 

 

 

Additional

Paid-in

 

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

 

Total

Stockholders’

 

 

 

 

Shares

 

Amount

 

 

 

Capital

 

 

 

Loss

 

 

Deficit

 

 

 

Equity

 

Balance, December 31, 2018

 

 

9,542

 

 

$

229,019

 

 

$

44,111

 

 

$

(575

)

 

$

(269,471

)

 

$

3,084

 

Adoption of ASC Topic 842-Leases

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(144

)

 

 

(144

)

Issuance of shares of common stock and

   warrants in connection with rights offering,

   net of issuance costs

 

 

5,976

 

 

 

34,399

 

 

 

 

 

 

 

 

 

 

 

 

34,399

 

Release of restricted stock units

 

 

6

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Warrants modification (see note 7)

 

 

 

 

 

 

 

 

1,577

 

 

 

 

 

 

(1,577

)

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

898

 

 

 

 

 

 

 

 

 

898

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,700

)

 

(9,700

)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(8

)

 

 

 

 

 

(8

)

Balance, March 31, 2019

 

 

15,524

 

 

 

263,418

 

 

 

46,586

 

 

 

(583

)

 

 

(280,892

)

 

 

28,529

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock in connection with  

   employee stock purchase plan

 

 

47

 

 

 

238

 

 

 

 

 

 

 

 

 

 

 

 

238

Release of restricted stock units

 

 

2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

859

 

 

 

 

 

 

 

 

 

859

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,440

)

 

(8,440)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

9

 

 

 

 

 

 

9

Balance, June 30, 2019

 

 

15,573

 

 

$

263,656

 

 

$

47,445

 

 

$

(574

)

 

$

(289,332

)

 

$

21,195

 

 

 

Common Stock

 

 

 

Additional

Paid-in

 

 

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

 

Total

Stockholders’

 

 

 

 

Shares

 

 

 

Amount

 

 

 

Capital

 

 

 

Loss

 

 

Deficit

 

 

 

Equity(Deficiency)

 

Balance, December 31, 2019

 

 

15,643

 

 

$

264,008

 

 

$

48,613

 

 

$

(562

)

 

$

(304,784

)

 

$

7,275

 

Repurchase of fractional shares in connection

   with reverse stock split

 

 

(2

)

 

 

(11

)

 

 

 

 

 

 

 

 

 

 

 

(11

)

Issuance of shares of common stock

 

 

1

 

 

 

6

 

 

 

 

 

 

 

 

 

 

 

 

6

 

Release of restricted stock units

 

 

15

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

279

 

 

 

 

 

 

 

 

 

279

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,886

)

 

(8,886

)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

19

 

 

 

 

 

 

19

 

Balance, March 31, 2020

 

 

15,657

 

 

 

264,003

 

 

 

48,892

 

 

 

(543

)

 

 

(313,670

)

 

 

(1,318

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of shares of common stock and warrants

   in connection with share offering, net of

   issuance costs

 

 

7,500

 

 

 

6,393

 

 

 

280

 

 

 

 

 

 

 

 

 

6,673

Repurchase of ESPP shares as part of a rescission

   offer

 

 

(39

)

 

 

(270

)

 

 

 

 

 

 

 

 

 

 

 

(270)

Stock-based compensation expense

 

 

 

 

 

 

 

 

88

 

 

 

 

 

 

 

 

 

88

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,100

)

 

(3,100)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

10

 

 

 

 

 

 

10

Balance, June 30, 2020

 

 

23,118

 

$

270,126

 

 

$

49,260

 

 

$

(533

)

 

$

(316,770

)

 

$

2,083

 

See accompanying notes.

6


 

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Condensed Consolidated Statements of Cash Flows

(in thousands)

 

 

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

 

 

(unaudited)

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(11,986

)

 

$

(18,140

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

126

 

 

 

196

 

Stock-based compensation

 

 

367

 

 

 

1,757

 

Non-cash lease expense

 

 

3

 

 

 

10

 

Inventory reserve

 

 

 

 

 

(446

)

Restructuring charges-inventory and fixed asset impairment

 

 

1,115

 

 

 

2,587

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

461

 

 

 

(122

)

Inventories

 

 

(144

)

 

 

(364

)

Prepaid expenses and other assets

 

 

(364

)

 

 

585

 

Accounts payable

 

 

(1,019

)

 

 

(49

)

Accrued expenses

 

 

108

 

 

 

192

 

Accrued compensation expenses

 

 

(2,369

)

 

 

(483

)

Accrued clinical trial expenses

 

 

(189

)

 

 

105

 

Contract liabilities

 

 

 

 

 

387

 

Net cash used in operating activities

 

 

(13,891

)

 

 

(13,785

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(331

)

 

 

(164

)

Net cash used in investing activities

 

 

(331

)

 

 

(164

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Net proceeds from sale of common stock and/or warrants

 

 

6,679

 

 

 

34,399

 

Proceeds from employee stock purchase plan

 

 

 

 

 

238

 

Repurchase of ESPP shares and fractional shares in connection with reverse stock split

 

 

(281

)

 

 

 

Net cash provided by financing activities

 

 

6,398

 

 

 

34,637

 

Effect of exchange rate changes on cash and cash equivalents

 

 

2

 

 

 

2

 

Cash and cash equivalents:

 

 

 

 

 

 

 

 

Net increase (decrease)

 

 

(7,822

)

 

 

20,690

 

Balance at beginning of period

 

 

11,327

 

 

 

4,471

 

Balance at end of period

 

$

3,505

 

 

$

25,161

 

Non-cash financing activities:

     Fair value of warrants issued in connection with issuance of common stock                                            $280                             $

 

 

 

See accompanying notes.

7


 

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

1. Organization and Business Operations

Second Sight Medical Products, Inc. (“Second Sight,” “we,” “us,” or “the Company”) was incorporated in the State of California in 2003. Second Sight develops implantable visual prosthetics to potentially enable blind individuals to achieve greater independence.

In 2007, Second Sight formed Second Sight Medical Products (Switzerland) Sàrl, initially to manage clinical trials and sales and marketing in Europe, the Middle East and Asia-Pacific, and more recently for the research of future technologies. As the laws of Switzerland require at least two corporate stockholders, Second Sight Medical Products (Switzerland) Sàrl is 99.5% owned directly by us and 0.5% owned by an executive of Second Sight as of June 30, 2020. Accordingly, Second Sight Medical Products (Switzerland) Sàrl is considered 100% owned for financial statement purposes and is consolidated with Second Sight for all periods presented. In June 2020, we commenced a process to dissolve our Swiss subsidiary which is expected to take approximately one year. 

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

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

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

Liquidity and Going Concern

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

 

Issuance of shares of common stock on May 5, 2020 which provided net proceeds of approximately $6.7 million.

 

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

 

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

 

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

 

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

 

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

On May 5, 2020, we closed our underwritten public offering of 7,500,000 shares of common stock at an offering price of $1.00 per share for aggregate net proceeds of approximately $6.7 million.

We received an award for $1.6 million grant (with the intent to fund $6.4 million over five years subject to annual review and approval) from the National Institutes of Health (NIH) to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis” that commenced in January 2018. Our second year grant was recently approved under this grant. As of June 30, 2020 we recorded $0.3 million of deferred grant costs which will be offset with the related grant funds when received. During the six months ended June 30, 2020, we received a total of $0.4 million of grant funds primarily from this grant.

8


 

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

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

 

In November 2017, we entered into an At Market Issuance Sales Agreement (“Sales Agreement”) with B. Riley FBR Inc. and H.C. Wainwright & Co., LLC, as agents (“Agents”) pursuant to which we offered and sold, from time to time through either of the Agents, shares of our common stock having an aggregate offering price as set forth in the Sales Agreement and a related prospectus supplement filed with the SEC. We agreed to pay the Agents a cash commission of 3.0% of the aggregate gross proceeds from each sale of shares under the Sales Agreement. During January and February 2018, we sold approximately 278,000 shares of common stock which provided net proceeds of $4.0 million under the Sales Agreement. During December 2019, we sold approximately 17,000 shares of common stock which provided net proceeds of $0.1 million under the Sales Agreement. In April 2020, we terminated the Sales Agreement with the Agents.

 

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 no revenue that is developing a novel medical device, including limitations on our operating capital resources. 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.  

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

Based upon our current plans we do not have sufficient funds to support our operations for the next 12 months from the date of issuance of these financial statements. Accordingly, these and other related factors raise substantial doubt about our ability to continue as a going concern. We anticipate that we will seek to additionally fund our operations through public or private equity or debt financings, grants, collaborations, strategic partnerships or other sources. However, we may be unable to raise additional capital or enter into such other arrangements when needed on favorable terms or at all. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or any other approved product candidates, or we may be unable to maintain our current limited operations, maintain our current organization and reduced employee base or otherwise capitalize on our business opportunities, as desired, which could materially and adversely affect our business, financial condition and results of operations. The accompanying financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.

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

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

Basis of Presentation

These unaudited interim financial statements have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and following the requirements of the United States Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. In our opinion, the unaudited interim financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of our financial position and our results of operations and cash flows for periods presented. These statements do not include all disclosures required by GAAP and should be read in conjunction with our financial statements and accompanying notes for the fiscal year ended December 31, 2019, contained in our Annual Report on Form 10-K filed with the SEC on March 19, 2020. The results of the interim periods are not necessarily indicative of the results expected for the full fiscal year or any other interim period or any future year or period.

9


 

Reverse Stok Split

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

 

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

Significant Accounting Policies

 

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

 

Based upon our decision on May 10, 2019 to accelerate our transition to the Orion platform and suspend production of Argus, we recorded impairment charges of $2.6 million related to inventory of Argus II in the six months ended June 30, 2019. As part of this transition we commenced a corporate restructuring plan to focus on development of Orion and other key research projects. On March 31, 2020, due to the COVID-19 pandemic and related inability to secure additional funding, we laid off the majority of our employees and reduced our operating expenses significantly to allow for our continuing business operations. Due to our focus on Orion and wind down of selling and marketing activities related to Argus II, we recorded further impairment charges to our inventory of $0.5 million and $0.7 million to our fixed assets used primarily for Argus activities. We also incurred $1.0 million in severance payments and other costs associated with the wind down, all of which were substantially paid by June 30, 2020. We continue to advance the development of our Orion technology and are exploring various strategic options, however we cannot assure that any of these endeavors will yield satisfactory results or that we will be able to maintain our operations.

 

    

Our significant accounting policies are set forth in Note 2 of the financial statements in our Annual Report on Form 10-K for the year ended December 31, 2019.

Recently Issued Accounting Pronouncements

We do not believe that any 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 us to concentrations of credit risk consist primarily of cash, money market funds, and trade accounts receivable. We maintain cash and money market funds with financial institutions that we deem reputable. We extended differing levels of credit to our customers, and typically did not require collateral.

Customer Concentration

The following tables provide information about disaggregated revenue by service type, customer and geographical market.

The following table shows our revenues by customer type during the three and six months ended June 30, 2020 and 2019:

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

Direct customers

 

$

 

 

$

1,006

 

 

$

 

 

$

1,952

Indirect customers (distributors)

 

 

 

 

 

276

 

 

 

 

 

 

458

Total

 

$

 

 

$

1,282

 

 

$

 

 

$

2,410

10


 

 

During the three and six months ended June 30, 2020 and 2019, the following customers each comprised greater than 10% of our total revenues:

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Customer 1

 

 

%

 

 

26

%

 

 

%

 

 

14

%

Customer 2

 

 

%

 

 

21

%

 

 

%

 

 

11

%

Customer 3

 

 

%

 

 

13

%

 

 

%

 

 

14

%

Customer 4

 

 

%

 

 

13

%

 

 

%

 

 

7

%

Customer 5

 

 

%

 

 

10

%

 

 

%

 

 

16

%

Customer 6

 

 

%

 

 

10

%

 

 

%

 

 

10

%

 

As of June 30, 2020 and December 31, 2019, the following customers each comprised greater than 10% of our total accounts receivable:

 

 

 

June 30,

2020

 

 

December 31,

2019

 

Customer 1

 

 

%

 

 

35

%

Customer 2

 

 

%

 

 

33

%

Customer 3

 

 

%

 

 

32

%

 

Geographic Concentration

During the three and six months ended June 30, 2020 and 2019, regional revenue based on customer locations which each comprised greater than 10% of our total revenues, consisted of the following:

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

United States

 

 

%

 

 

68

%

 

 

%

 

 

65

%

China

 

 

%

 

 

13

%

 

 

%

 

 

7

%

Italy

 

 

%

 

 

10

%

 

 

%

 

 

16

%

 

Foreign Operations

The accompanying condensed consolidated financial statements as of June 30, 2020 and December 31, 2019 include gross assets amounting to $0.9 million and $1.3 million, respectively, relating to operations of our subsidiary based in Switzerland. It is possible that unanticipated events in foreign countries could disrupt our operations. The assets of the subsidiary, net of reserves and allowances amounted to approximately $0.1 million at June 30, 2020.

4. Fair Value Measurements

The authoritative guidance with respect to fair value establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels, and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required.

Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that we 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 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.

Cash equivalents, which includes money market funds, are the only financial instrument measured and recorded at fair value on our consolidated balance sheet, and they are valued using Level 1 inputs.

11


 

Assets measured at fair value on a recurring basis are as follows (in thousands):

 

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

June 30, 2020 (unaudited):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

3,437

 

 

$

3,437

 

 

$

 

 

$

 

December 31, 2019:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

11,307

 

 

$

11,307

 

 

$

 

 

$

 

         

 

5. Selected Balance Sheet Detail

Inventories, net

Inventories consisted of the following (in thousands):

 

 

 

June 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Raw materials

 

$

741

 

 

$

803

 

Work in process

 

 

1,461

 

 

 

1,716

 

Finished goods

 

 

1,290

 

 

 

2,069

 

 

 

 

3,492

 

 

 

4,588

 

Allowance for excess and obsolete inventory and impairment charge

 

 

(3,492

)

 

 

(3,559

)

Inventories, net

 

$

 

 

$

1,029

 

 

We recorded $2.6 million as an impairment charge during the six months ended June 30, 2019, related to our plans to suspend Argus II production. We recorded further impairment charges to our inventory of $0.5 million in the first six months of 2020. Additionally, finished goods inventory amounting to approximately $0.4 million that we expect to use for our future warranty claims has been offset with the warranty accrual which is included in accrued expenses.

 

Property and equipment

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

 

 

 

June 30,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Laboratory equipment

 

$

584