eyes-10q_20200930.htm

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.

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).

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

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

	September 30,			December 31,
	2020			2019
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	2,437		$	11,327
Accounts receivable, net		—			455
Inventories, net		—			1,029
Prepaid expenses and other current assets		872			299
Total current assets		3,309			13,110
Property and equipment, net		193			1,122
Right-of-use assets		—			2,342
Deposits and other assets		20			25
Total assets	$	3,522		$	16,599

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	285		$	1,093
Accrued expenses		1,260			1,889
Accrued compensation expense		393			2,698
Accrued clinical trial expenses		707			707
Current operating lease liabilities		—			237
Contract liabilities		335			335
Total current liabilities		2,980			6,959
Long term operating lease liabilities		—			2,365
Total liabilities		2,980			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 September 30, 2020 and December 31, 2019, respectively		270,126			264,008
Additional paid-in capital		49,287			48,613
Accumulated other comprehensive loss		(498	)		(562	)
Accumulated deficit		(318,373	)		(304,784	)
Total stockholders’ equity		542			7,275
Total liabilities and stockholders’ equity	$	3,522		$	16,599

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Net sales	$	—		$	472		$	—		$	2,882
Cost of sales		—			364			—			2,028
Gross profit		—			108			—			854

Operating expenses:
Research and development, net of grants		279			3,379			4,489			8,998
Clinical and regulatory, net of grants		261			862			1,604			2,404
Selling and marketing		—			1,308			701			5,100
General and administrative		1,062			2,178			4,599			6,883
Restructuring charges		—			—			2,229			3,297
Total operating expenses		1,602			7,727			13,622			26,682

Loss from operations		(1,602	)		(7,619	)		(13,622	)		(25,828)
Miscellaneous income (expense), net		(1	)		35			33			104

Net loss	$	(1,603	)	$	(7,584	)	$	(13,589	)	$	(25,724)

Net loss per common share – basic and diluted	$	(0.07	)	$	(0.49	)	$	(0.69	)	$	(1.79)

Weighted average common shares outstanding – basic and diluted		23,118			15,574			19,714			14,408

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

	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

Release of restricted stock units		2		—		—		—			—			—
Stock-based compensation expense		—		—		686		—			—			686
Net loss		—		—		—		—			(7,584	)		(7,584	)
Foreign currency translation adjustment		—		—		—		(11	)	—				(11	)
Balance, September 30, 2019		15,575	$	263,656	$	48,131	$	(585	)	$	(296,916	)	$	14,286

	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

Stock-based compensation expense		—			—			27		—			—			27
Net loss		—			—			—		—		(1,603		)		(1,603	)
Foreign currency translation adjustment		—			—			—		35		—				35
Balance, September 30, 2020		23,118		$	270,126		$	49,287	$	(498	)	$	(318,373	)	$	542

	Nine Months Ended September 30,
	2020			2019
	(unaudited)
Cash flows from operating activities:
Net loss	$	(13,589	)	$	(25,724	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		148			293
Stock-based compensation		394			2,443
Non-cash lease expense		3			13
Inventory reserve		—			(793	)
Restructuring charges-inventory and fixed asset impairment		1,116			2,587
Changes in operating assets and liabilities:
Accounts receivable		461			240
Inventories		218			186
Prepaid expenses and other assets		(568	)		1,010
Accounts payable		(1,256	)		(178	)
Accrued expenses		64			(282	)
Accrued compensation expenses		(2,360	)		(227	)
Accrued clinical trial expenses		—			(199	)
Contract liabilities		—			388
Net cash used in operating activities		(15,369	)		(20,243	)
Cash flows from investing activities:
Sale of assets held for sale		398			—
Purchases of property and equipment		(331	)		(394	)
Net cash provided by (used in) investing activities		67			(394	)
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		14			(9	)
Cash and cash equivalents:
Net increase (decrease)		(8,890	)		13,991
Balance at beginning of period		11,327			4,471
Balance at end of period	$	2,437		$	18,462

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

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 September 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.

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:

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 September 30, 2020 we recorded $0.6 million of deferred grant costs which will be offset with the related grant funds when received. During the nine months ended September 30, 2020, we received a total of $0.4 million of grant funds primarily from this grant.

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 9, 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

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.

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.

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 production and 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 nine months ended September 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 September 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.

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.

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.

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 nine months ended September 30, 2020 and 2019:

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

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Customer 1		—	%		44	%		—	%		23	%
Customer 2		—	%		29	%		—	%		12	%
Customer 3		—	%		28	%		—	%		6	%
Customer 4		—	%		—	%		—	%		12	%
Customer 5		—	%		—	%		—	%		11	%

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

PART I	FINANCIAL INFORMATION

Item 1.	Financial Statements

	Condensed Consolidated Balance Sheets as of September 30, 2020 (unaudited) and December 31, 2019	3
	Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2020 and 2019 (unaudited)	4
	Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2020 and 2019 (unaudited)	5
	Condensed Consolidated Statements of Stockholders’ Equity (Deficiency) for each of the three-month periods ended during the nine months ended September 30, 2020 and 2019 (unaudited)	6
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 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	32

Item 3.	Defaults Upon Senior Securities	32

Item 4.	Mine Safety Disclosures	32

Item 5.	Other Information	32

Item 6.	Exhibits	33

SIGNATURES		34

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☐