Vivani Medical, Inc. - Quarter Report: 2015 June (Form 10-Q)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended June 30, 2015

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

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 x 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 (§229.405 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 x 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. See the definitions of “large accelerated filer”, “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).      Yes ¨ No x

As of July 31, 2015, the issuer had 35,826,019 shares of common stock issued and outstanding. 

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

INDEX TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

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

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

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)

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

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

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

SECOND SIGHT MEDICAL PRODUCTS, INC.

AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

Six Months Ended June 30, 2015 and 2014

1.  Organization and Business Operations

Organization and Business Operations

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

In 2007, Second Sight formed Second Sight (Switzerland) Sarl, initially to manage clinical trials for its products in Europe, and later to manage sales and marketing in Europe and the Middle East. As the laws of Switzerland require at least two corporate stockholders, Second Sight (Switzerland) Sarl is 99.5% owned directly by the Company and 0.5% owned by an executive of Second Sight, who is acting as a nominee of the Company. Accordingly, Second Sight (Switzerland) Sarl is considered 100% owned for financial statement purposes and is consolidated with Second Sight for all periods presented.

Since its inception, the Company has generated limited revenues from the sale of products and has financed its operations primarily through the issuance of common stock, convertible debt (which has been converted into common stock), and grants primarily from government agencies. The Company’s initial public offering (“IPO”) in November 2014 has provided it with sufficient financial resources to fund its operations for a period in excess of the next twelve months through June 2016. 

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

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission for Form 10-Q. Accordingly, certain information and footnote disclosures normally included in 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, 2014 has been derived from the Company’s audited consolidated financial statements.

In the opinion of management, these financial statements reflect all normal recurring and other adjustments necessary for a fair presentation. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. Operating results for interim periods are not necessarily indicative of operating results for an entire fiscal year or any other future periods.

Significant Accounting Policies

The Company’s significant accounting policies are set forth in Note 2 in its Annual Report on Form 10-K for the year ended December 31, 2014.

Recent Accounting Pronouncements

Management does 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 the Company to concentrations of credit risk consist primarily of cash, money market funds, and trade accounts receivable. The Company maintains 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 six months ended June 30, 2015 and 2014 (unaudited), the following customers comprised more than 10% of revenues:

As of June 30, 2015 and December 31, 2014, the following customers comprised more than 10% of accounts receivable:

Geographic Concentration 

During the three and six months ended June 30, 2015 and 2014 (unaudited), regional revenue, based on customer location, consisted of the following:

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 cause time delays that impede the commercial production of the Argus II, reduce gross profit margins and impact the Company’s abilities to deliver its products as may be timely required to meet demand.

Foreign Operations

The accompanying condensed consolidated financial statements as of June 30, 2015 (unaudited) and December 31, 2014 include assets amounting to $3,879,000 and $2,091,000, respectively, relating to operations of the Company in Switzerland. It is possible that unanticipated events in foreign countries could disrupt the Company’s operations.

4. Money Market Funds

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 has 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.

Money market funds are the only financial instrument that is measured and recorded at fair value on the Company’s balance sheet, and they are considered Level 1 valuation securities. The following table presents money market funds at their level within the fair value hierarchy at June 30, 2015 and December 31, 2014.

5.  Selected Balance Sheet Detail

Inventories, net

Inventories consisted of the following at:

Property and equipment, net of accumulated depreciation and amortization

Property and equipment consisted of the following at:

6. Long Term Investor Right

Investors who purchased shares in the Company’s IPO, and who complied with certain terms and conditions, such as holding their IPO shares in their name during the twenty-four month period following the closing of the IPO, are entitled under certain conditions to receive up to one additional share for each share they purchased in the IPO. For a more complete discussion of the Long Term Investor Right, see Note 2 in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014.

As of June 30, 2015, the Company identified investors who had perfected and maintained Long Term Investor Rights in 1,435,600 shares of common stock that were acquired as part of the Company’s IPO. The highest average closing price for the Company’s common stock on NASDAQ during any consecutive 90 day period ended on or before June 30, 2015 was $13.37. Based on this average closing stock price, an investor who purchased shares as part of the IPO, and who has perfected its Long Term Investor Right, would be entitled to 0.3458 shares for each share purchased in the IPO, rounded up to the next whole share, which represents an aggregate maximum of 496,548 shares that are potentially issuable by the Company pursuant to the Long Term Investor Right at such date. The actual number of common shares issuable pursuant to the Long Term Investor Right is dependent on the future stock price of the Company over the two year period subsequent to the November 24, 2014 closing date of the IPO, and could be as high as 496,548 shares and as low as zero shares.

The Long Term Investor Right is an equity instrument that is being accounted for as a component of the actual price per common share paid by the investor in the IPO. For basic earnings per share, the common shares associated with the Long Term Investor Right are treated as contingently issuable shares and are not being included in basic earnings per share until the actual number of shares can be calculated and the shares have been issued.

7. Equity Securities

Common Stock Issuable

Beginning with services rendered in 2014, and with the first payment in June 2015, non-employee members of the Board of Directors are paid for their services in common stock on June 1 of each year based on the average closing prices for the immediately preceding twenty trading days. In June 2015, the Company issued 23,136 shares to Directors for services rendered through May 2015. As of June 30, 2015, the Company accrued $28,583 for these services, which equates to 2,100 shares based on the $13.61 closing price for Company’s common stock on that date. These shares have not yet been issued and are excluded from the calculation of weighted average common shares outstanding for EPS purposes.

Potentially Dilutive Common Stock Equivalents

At June 30, 2015 and 2014 (unaudited), the Company excluded the outstanding securities summarized below, which entitle the holders thereof to ultimately acquire shares of common stock, from its calculations of earnings per share and weighted average shares outstanding, as their effect would have been anti-dilutive.

8. Warrants

A summary of warrant activity for the six months ended June 30, 2015 (unaudited) is presented below.

The intrinsic value of warrants outstanding at June 30, 2015 was approximately $10.9 million. During the six months ended June 30, 2015, warrants representing 136,056 shares of common stock were exercised for proceeds of $0.7 million.

9. Stock-Based Compensation

Under the 2003 Plan, as restated in June 2011, and amended in 2015, the Company is authorized to issue stock options covering up to 6,000,000 common shares.

A summary of stock option activity for the six months ended June 30, 2015 (unaudited) is presented below.

The estimated aggregate intrinsic value of stock options exercisable at June 30, 2015 was approximately $12.1 million. As of June 30, 2015, there was $7.8 million of total unrecognized compensation cost related to outstanding stock options that will be recognized over a weighted average period of 3.48 years.

On January 1, 2015, the Company’s Chief Executive Officer exercised stock options expiring on that date on a cashless basis to purchase 59,063 shares of common stock at an exercise price of $4.75 per share. Based on the closing market price of the Company’s common stock of $10.26 on December 31, 2014, the Chief Executive Officer tendered 27,344 shares of common stock that he owned to satisfy the aggregate exercise price and surrendered 12,055 shares of common stock to satisfy the related $123,684 of income and payroll tax withholding amounts related to the transaction.

On June 2, 2015 and June 3, 2015 the Company’s Chief Executive Officer exercised stock options on a cashless basis to purchase 150,000 shares of common stock at an exercise price of $4.75 per share. Related to these exercises, the Chief Executive Officer tendered 50,753 shares of common stock that he owned to satisfy the aggregate exercise price.

During the six months ended June 30, 2015, the Company granted stock options to purchase 517,848 shares of common stock to certain employees and contractors. The options are exercisable for a period of ten years from the date of grant at $12.46 to $13.90 per share, which was the fair value of the Company’s common stock on such dates. The options vest over a period of either four or five years. The fair value of these options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $3,356,325 ($6.48 average per share). On a weighted average basis, assumptions used in the model were an expected term of 6.38 years, volatility of 50.4%, a risk-free interest rate of 2.2% and an expected dividend rate of 0%.

On May 15, 2015 shareholders approved (1) an increase of 2,000,000 shares in the number of shares available for option awards under the 2011 Equity Incentive Plan, and (2) an Employee Stock Purchase Plan, with an initial 250,000 shares with annual increases of shares available equal to the lesser of (i) 1% of outstanding shares or (ii) 100,000 shares.

The Company initiated an employee stock purchase plan in June, 2015 for all eligible employees. Under the plan, shares of the Company's common stock may be purchased at six-month intervals at 85% of the lower of the 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 June 30, 2015, 250,000 shares were reserved for future issuance.

On June 19, 2015 the Company entered into an at will employment agreement with Will McGuire to become the Company’s President and Chief Executive Officer. The Company has agreed to pay Mr. McGuire an annual salary of $390,000 and he will also be entitled to receive performance bonuses which will be based on performance standards and goals established by the Company’s Board of Directors. Upon termination without cause, Mr. McGuire will be entitled to receive severance consisting of his salary for a period of 12 months following such termination and his pro-rated target bonus through the balance of the calendar year in which such termination occurs. As part of the agreement, the Company agreed to grant Mr. McGuire, effective on his official start date as an employee, options to purchase 420,000 shares of the Company’s common stock and 190,000 Restricted Stock Units (RSUs). The options will be priced at the closing price of the Company’s stock on Nasdaq at the close of trading on the business day prior to his official start date which is expected to be no later than August 18, 2015. The options and RSUs will vest over four years, with twenty-five percent vesting on the first anniversary of the grant date, and the remainder vesting thereafter in twelve equal installments of six and one quarter percent on the quarterly anniversaries of the grant date.

The total stock-based compensation recognized for stock-based awards in the condensed consolidated statements of operations for the three and six months ended June 30, 2015 and 2014 (unaudited) is as follows:

10.  Litigation, Claims and Assessments

Ten oppositions have been filed by a third-party in the European Patent Office, each challenging the validity of a European patent owned or exclusively licensed by the Company. The outcome of the challenges is not certain, however, if successful, they may affect the Company's ability to block competitors from utilizing some of its patented technology in Europe. Management of the Company does not believe a successful challenge will have a material effect on its ability to manufacture and sell its products, or otherwise have a material effect on its operations.

The Company may be party to litigation arising in the ordinary course of business. It is management's opinion that the outcome of such matters will not have a material effect on the Company's financial statements.

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 conjunction with the unaudited condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q, as well as our audited 2014 financial statements and related notes included in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 17, 2015. In addition to historical information, the discussion and analysis here and throughout this Form 10-Q contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including, but not limited, to those set forth under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K which we filed with the Securities and Exchange Commission on March 17, 2015.

We were founded in 1998 with a mission to develop, manufacture, and market prosthetic devices that restore vision to the blind. Our principal offices are located in Sylmar, California, approximately 25 miles northwest of downtown Los Angeles. We also have an office in Lausanne, Switzerland, that manages our commercial and clinical operations in Europe and the Middle East.

Our first commercial product, the Argus II System, is a retinal prosthesis that can provide some functional vision to individuals blinded by retinitis pigmentosa (RP). The Argus II System is an implantable neurostimulation device that uses electrical stimulation of the retina (based on a wireless video camera feed) to replace the function of the defunct photo-receptors in RP patients.

Our major corporate, clinical and regulatory milestones include:

We began selling the Argus II System in Europe at the end of 2011, in Saudi Arabia in 2012, in the United States, Spain and Canada in 2014, and in Turkey in 2015. To date, most of our implant sales have been made by our direct sales force, but we plan to expand the volume of business done through third-party channels as we add more partners and distributors to enhance our coverage of existing and future markets. We have entered into distribution agreements, that cover the countries of Spain, Turkey and Saudi Arabia, and we are at various stages of negotiations with a number of other distributors for countries in Europe and the Middle East. In the second quarter of 2015, our distributors in Spain and Turkey each accounted for their first implants.

We have achieved certain insurance reimbursement milestones in the United States (Medicare Transitional Pass Through Payment, New Technology Add-on Payment, and coverage by a number of insurers/payers), but reimbursement hurdles remain as not every payer is covering this technology. Currently, two Medicare Administrative Contractors (“MACs”), covering Ohio, Kentucky, North and South Carolina, West Virginia and parts of Virginia, have agreed to cover the Argus II System for FDA approved indications. We are in discussions with additional MACs that cover the rest of the United States regarding coverage for the Argus II System.

In Europe, we have achieved national reimbursement in Germany and France, and have regional reimbursement in parts of Italy. Additional reimbursement is being sought in a number of other countries. Obtaining reimbursement from governmental or private insurance companies is critical to our future commercial success. Due to the cost of the Argus II System, our sales will be limited without the availability of third party reimbursement.

Plan of Operation

We currently market and sell our products in the United States, Canada, Europe, Turkey and Saudi Arabia. Over the next two years, we intend to use approximately $2.0 to $4.0 million of the proceeds from our IPO to expand our sales and marketing organizations in these existing markets to increase sales coverage, market penetration and revenue in these markets. We intend to introduce the Argus II System in additional countries through our direct sales force or by working with distributors.

We intend to use approximately $4.0 million of the proceeds from our IPO on development and clinical efforts to enhance the external hardware and software of our Argus II System, which could improve the resolution and other performance characteristics of the system. Increasing the resolution of the system may enhance the user experience and increase our potential market size. Image resolution may be achieved by enhanced image processing, including contrast enhancement and electronic zooming. In addition, we believe that, through software enhancements, we may be able to create a number of virtual electrodes between the physical electrodes on the current retinal implant. This could potentially enhance the resolution of existing devices by ten-fold or more.

Currently, our Argus II System is approved for persons suffering from RP. We believe we may be able to expand the market for the Argus II System beyond RP to patients with severe to profound vision loss due to age-related macular degeneration or AMD. We intend to use approximately $2.0 million of the proceeds from our IPO to conduct a pilot study, of about five patients to evaluate the safety and benefit of the Argus II System for use in persons suffering from AMD. Recruitment for this study began in December 2014 and we began implanting in this study in the first half of 2015. If results from this study are promising, we anticipate beginning a larger scale efficacy trial in 2016 that could lead to FDA marketing approval for the Argus II system for AMD patients in 2019. In Europe, our CE Mark approval for the Argus II was written broadly enough to include AMD. Accordingly, we anticipate that we will be able to begin marketing the product sooner in Europe than in the United States, once efficacy for use in AMD patients has been established. We estimate that the cost to complete this additional trial would be approximately $4.5 million. If the Argus II System is successfully developed and approved for sale to treat AMD, as to which there can be no assurances, we believe that the potential addressable market opportunity for that device will significantly exceed our existing RP markets for the Argus II System.

We also plan to use approximately $5.0 million of the proceeds from our IPO to conduct preclinical development of a product for cortical stimulation that we refer to as the Orion I visual cortical prosthesis, which we expect will be able to provide some vision restoration to individuals with almost all unpreventable forms of blindness. Our objective in designing and developing the Orion I visual cortical prosthesis is to bypass the retina and optic nerve and to directly stimulate the visual cortex region of the brain. Human clinical testing is likely to take the form of a feasibility study followed by a premarket approval pivotal trial. The details of these trials will be determined collaboratively with the FDA at that time. We cannot accurately estimate the timing or exact cost of these trials at this time. If the Orion I visual cortical prosthesis is successfully developed and approved for sale, as to which there can be no assurances, we believe that the potential addressable market opportunity for that device will greatly exceed our existing RP markets for the Argus II System.

The amounts that we actually spend for any specific purpose may vary significantly and will depend on a number of factors, including, but not limited to, the pace of progress of our commercialization and development efforts, actual needs with respect to research and development, clinical testing, regulatory approval, market conditions, insurance reimbursement, and changes in or revisions to our product, sales and marketing strategies. Investors will be relying on the judgment of our management regarding the application of the proceeds from the sale of our common stock.

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, 2014. There have been no material changes to our critical accounting policies during the six months ended June 30, 2015.

Results of Operations

Net sales. Our net sales are derived primarily from the sale of our Argus II System, and related clinical programming systems and surgical supplies. We began selling our products in Europe in 2011, Saudi Arabia in 2012, the United States and Canada in 2014, and Turkey in 2015. 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 and obsolete inventory, and other costs required to make our Argus II System at our Sylmar, California facility. Historically, our cost of sales was greater than our revenues, which resulted in gross losses. However, beginning in the second half of fiscal 2014, due to higher revenues and increased manufacturing output and efficiencies, we began generating positive gross margins. Our product involves new and technologically complex materials and processes. As we move from making small quantities of our product for clinical trials to larger quantities for commercial distribution, we are developing new manufacturing techniques and processes that we expect will allow us to scale production. We are currently experiencing low yields on our manufacturing process, but we expect that over the next few years we will be able to refine our processes and improve our manufacturing yields. Accordingly, as we scale our production over the next few years, we expect that our cost per unit will decrease and we will continue to generate positive gross profit and increasing gross margins.

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.

Interest expense on convertible promissory notes. Interest expense was a non-cash expense associated with the Company’s convertible promissory notes issued during fiscal 2013 and 2012. Simple interest was accrued at 7.5% per annum based on the face value of the convertible promissory notes outstanding during the relevant reporting period. The accrued interest was added to the amount of outstanding debt, but did not earn additional interest. The terms of the convertible promissory notes provided for automatic conversion of principal and accrued interest into equity on our IPO, at $5.00 per share. Accordingly, subsequent to our IPO in the fourth quarter of 2014, the Company no longer incurred interest expense on the convertible promissory notes.

Amortization of discount on convertible promissory notes. Convertible promissory notes issued during 2012 and 2013 were issued with detachable warrants and an embedded beneficial conversion feature, which were recorded as an issuance discount with an offsetting credit to additional paid-in capital. This issuance discount was amortized as a non-cash charge over the term of the convertible promissory note. The terms of the convertible promissory notes provided for conversion into equity on an IPO, at $5.00 per share. As a result of our IPO in November 2014, unamortized issuance costs were charged to income due to the automatic conversion of all outstanding convertible promissory notes into common stock. Accordingly, subsequent to our IPO in the fourth quarter of 2014, the Company no longer amortized the issuance discount on the convertible promissory notes.

Comparison of the Three Months Ended June 30, 2015 and 2014

Net Sales. Our net sales increased from $611,477 in the three months ended June 30, 2014 to $2,661,099 in the three months ended June 30, 2015, an increase of $2,049,622, or 335%. This increase in net sales was due to a higher number of implants performed in the second quarter of 2015 and the recognition of certain previously deferred revenue.

In the second quarter of 2015, twenty Argus II Systems were implanted compared to three in the same period of the prior year. Of these, there were thirteen implants in Europe and the Middle East (“EMEA”) in the second quarter of the current year compared to one implant in the same period of the prior year. The increase in implants in EMEA in the current year is primarily attributable to reimbursement programs in France and Italy, which combined accounted for nine implants in the second quarter of the current year compared to none during the same period of the prior year. In the United States and Canada (collectively “North America”), there were seven implants in the second quarter of 2015 compared to two implants in the same period of the prior year.

For the quarter ended June 30, 2015, average revenue recognized per implant was approximately $133,000 as compared to $204,000 in the same period of the prior year. The amount of revenue recognized per implant in a period depends on several factors, including average selling prices, exchange rates, the mix of implants between EMEA and North America, payment and reimbursement terms that may affect revenue recognition, and sales of ancillary products, such as clinical start-up kits and surgical supplies. In the second quarter of 2014, we had a small population of three implants that were sold at higher than average prices. Additionally, the three implants included clinical start-up kits and surgical supplies, which are sold with the first implant at a site. In the second quarter of 2015, we recognized approximately $360,000 more of previously deferred revenue than we deferred from the current quarter as a result of reimbursement uncertainties. In the second quarter of 2014, there was no impact from revenue deferrals. In the long term, we expect that our revenue per implant will range from $110,000 to $125,000, depending on exchange rates and the implant mix between EMEA and North America, where the average selling prices tend to be higher. In the United States the amount of sales revenue recognized per unit has been limited due to the uncertainties of the reimbursement environment and payment terms. Favorable claims outcomes and the development of positive coverage policies in the United States may eventually result in greater and earlier revenue recognition.

Cost of sales. Cost of sales increased from $993,054 in the three months ended June 30, 2014 to $1,569,386 in the same period of 2015, an increase of $576,332, or 58%. This increase in cost of goods sold is due to a higher number of units shipped offset by a lower cost per unit and a lower level of inventory write-offs in the current period. This decrease in cost per unit sold is primarily due to increasing our production volume and yields in the second quarter of 2015 relative to 2014. As we manufacture more products, our manufacturing overhead is spread over more units and our cost per unit produced decreases. Also, as our yields improve and we accept more units into inventory, the amount of scrapped product that is written off to cost of sales decreases. We will continue to invest in improving our manufacturing processes, and we expect manufacturing yields will improve and cost of sales will decrease relative to our revenues over the next few years, although we expect significant fluctuations on a quarter to quarter basis in our cost of sales and gross margins.

Research and development expense. Research and development expense decreased in the three months ended June 30, 2015 compared to the same period of 2014, by $371,425, or 30% from $1,220,189 in 2014 to $848,764 in 2015. In the second quarter of 2015, we utilized $512,093 of grant funding to offset labor, consulting and overhead costs incurred. To date, we have recognized $529,602 out of a total $4,075,000 related to a grant from The Johns Hopkins University Applied Physics Laboratory. Excluding the benefit of grant funds recognized in the second quarter of 2015, research and development expense increased by $140,668, or 12% compared to the prior year second quarter, primarily due to higher spending for consultants related to the development of next generation products. We expect research and development costs to increase in the future as we pursue further enhancements of our existing product and develop technology for our potential future cortical implant product, however, the amount of expense recognized may vary depending on the amount of grant funding utilized in future periods.

Clinical and regulatory expense. Clinical and regulatory expense increased from $712,473 in the three months ended June 30, 2014 to $892,348 in the same period of 2015, an increase of $179,875, or 25%. This increase is primarily attributable to a higher level of clinical and regulatory activity reflecting increased enrollment in post-market studies being conducted in the US and Europe as well as initial expenditures for our AMD trial. We expect clinical and regulatory costs to increase in the future as we conduct clinical trials to assess further enhancements to our existing product, and to continue to assess the safety and efficacy of our current product for treating blindness due to age related macular degeneration.

Selling and marketing expense. Selling and marketing expense increased from $1,828,586 in the three months ended June 30, 2014 to $2,297,989 in the same period of 2015, an increase of $469,403, or 26%. This increase in costs is primarily attributable to higher salary and benefit expenses as we ramped up our commercialization efforts in the United States and Europe. While we expect selling and marketing 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 from $1,420,051 in the three months ended June 30, 2014 to $2,000,105 in the same period of 2015, an increase of $580,054, or 41%. This increase is primarily attributable to higher costs for salaries, benefits, stock-based compensation and other costs associated with being a public company, including increased expenditures on audit and legal fees, insurance and investor relations. We expect general and administrative costs to increase in the future as we grow the administrative structure to support the growth of the Company.

Interest expense on the convertible promissory notes. Interest expense on the convertible promissory notes decreased from $551,970 in the three months ended June 30, 2014 to $0 in the same period of 2015. This decrease is due to the automatic conversion of our convertible promissory notes into common stock as a result of our IPO in November 2014, subsequent to which the Company no longer incurred interest expense on the convertible promissory notes.

Amortization of issuance discount on convertible promissory notes. Amortization of issuance discount on convertible promissory notes decreased from $1,440,015 in the three months ended June 30, 2014 to $0 in the same period of 2015. This decrease is due to the automatic conversion of our convertible promissory notes into common stock as a result of our IPO in November 2014, subsequent to which the Company no longer expensed the amortization of issuance costs related to the convertible promissory notes.

Comparison of the Six Months Ended June 30, 2015 and 2014

Net Sales. Our net sales increased from $1,268,203 for the six months ended June 30, 2014 to $4,361,181 for the six months ended June 30, 2015, an increase of $3,092,978 or 244%. This increase in net sales was due to a higher number of implants performed in 2015, but at a lower average amount of recognized revenue per implant than in the same period of the prior year.

There were thirty-nine Argus II Systems implanted in the first six months of 2015 compared to nine in the first six months of 2014. Of these, twenty-five implants were in EMEA in the first six months of 2015 compared to three in the first six months of 2014. The increase in EMEA is primarily attributable to the reimbursement programs in France and Italy, which combined accounted for nineteen implants in the first six months of 2015, whereas there were no implants in France or Italy in the first six months of 2014. In North America, there were fourteen implants in the first six months of 2015 compared to six implants in the same period of the prior year.

For the six months ended June 30, 2015, average revenue recognized per implant was approximately $112,000 as compared to approximately $141,000 in the same period of the prior year. The amount of revenue recognized per implant in a period depends on several factors, including average selling prices, exchange rates, the mix of implants between EMEA and North America, payment and reimbursement terms that may affect revenue recognition, and sales of ancillary products, such as clinical start-up kits and surgical supplies. In the first six months of 2015, we deferred a net of approximately $320,000 of revenue to future quarters due to reimbursement uncertainties. Longer term, we expect that our revenue per implant will range from $110,000 to $125,000, depending on exchange rates and the implant mix between EMEA and North America, where the average selling prices tend to be higher. In the United States the amount of sales revenue recognized per unit has been limited due to the uncertainties of the reimbursement environment and payment terms. Favorable claims outcomes and the development of positive coverage policies in the United States may eventually result in greater and earlier revenue recognition.

Cost of sales. Cost of sales increased from $1,720,487 in the first six months of 2014 to $2,865,139 in the first six months of 2015, an increase of $1,144,652 or 67%. This increase in cost of goods sold is due to a higher number of units shipped offset by a lower cost per unit and a lower level of inventory write-offs in the current period. This decrease in cost per unit sold is primarily due to increasing our production volume and yields in the first six months of 2015 relative to 2014. As we manufacture more products, our manufacturing overhead is spread over more units and our cost per unit produced decreases. Also, as our yields improve and we accept more units into inventory, the amount of scrapped product that is written off to cost of sales decreases. We will continue to invest in improving our manufacturing processes, and we expect manufacturing yields will improve and cost of sales will decrease relative to our revenues over the next few years, although we expect significant fluctuations on a quarter to quarter basis in our cost of sales and gross margins.

Research and development expense. Research and development expense decreased in the first six months of 2015 compared to the same period of 2014, decreasing $363,054, or 16% from $2,259,675 in 2014 to $1,896,621 in 2015. In the first six months of 2015, we utilized $529,602 of grant funds to offset labor, consulting and overhead costs incurred. Excluding this grant offset, there was an increase in research and development costs of $166,548 as we continued to pursue further enhancements of our existing product and develop technology for our potential future cortical implant product. The amount of expense recognized in future periods will vary depending on the amount of grant funding utilized in future periods.

Clinical and regulatory expense. Clinical and regulatory expense increased from $1,307,135 in the first six months of 2014 to $1,558,820 in the same period of 2015, an increase of $251,685, or 19%. This increase is primarily attributable to a higher level of clinical and regulatory activity reflecting increased enrollment in post-market studies being conducted in the US and Europe as well as initial expenditures for our AMD trial. We expect clinical and regulatory costs to increase in the future as we conduct clinical trials to assess further enhancements to our existing product, and to continue to assess the safety and efficacy of our current product for treating blindness due to age related macular degeneration.

Selling and marketing expense. Selling and marketing expense increased from $3,083,089 in the first six months of 2014 to $4,292,951 in the same period of 2015, an increase of $1,209,862, or 39%. This increase in costs is attributable to an increase in personnel, as well as higher costs for marketing and customer awareness programs, as we began selling our product in the United States, Canada, Spain and Turkey. 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 from $2,917,178 in the first six months of 2014 to $3,655,921 in the same period of 2015, an increase of $738,743, or 25%. This increase is primarily attributable to higher costs for salaries, benefits and outside services in the current year, partially offset by lower stock-based compensation charges. The increase in outside services reflects the higher cost of being a public company, and included increased expenditures on audit and legal fees, insurance and investor relations. We expect general and administrative costs to increase in the future as we grow the administrative structure to support the growth of the Company.

Interest expense on the convertible promissory notes. Interest expense on the convertible promissory notes decreased from $1,097,870 in the first six months of 2014 to $0 in the same period of 2015. This decrease is due to the automatic conversion of our convertible promissory notes into common stock as a result of our IPO in November 2014, subsequent to which the Company no longer incurred interest expense on the convertible promissory notes.

Amortization of issuance discount on convertible promissory notes. Amortization of issuance discount on convertible promissory notes decreased from $2,880,032 in the first six months of 2014 to $0 in the same period of 2015. This decrease is due to the automatic conversion of our convertible promissory notes into common stock as a result of our IPO in November 2014, subsequent to which the Company no longer expensed the amortization of issuance costs related to the convertible promissory notes.

Liquidity and Capital Resources

Cash and money market funds decreased by $8,031,734, or 23%, from $34,618,974 at December 31, 2014 to $26,587,240 at June 30, 2015. Working capital was $26,905,133 at June 30, 2015, as compared to $33,524,991 at December 31, 2014, a decrease of $6,619,858, or 20%. We use our cash, money market funds and working capital to fund our operating activities.

Cash Flows from Operating Activities

During the six months ended June 30, 2015, we used $9,892,664 of cash in operating activities, consisting primarily of a net loss of $9,878,712, offset by non-cash charges of $1,366,815 for depreciation and amortization of property and equipment, stock-based compensation and common stock issuable and increased by a net change in operating assets and liabilities of $1,380,767. This compares to the six months ended June 30, 2014, in which we used $10,278,480 of cash in operating activities, consisting primarily of a net loss of $13,979,828, offset by non-cash charges of $4,946,169 for depreciation and amortization of property and equipment, stock-based compensation, amortization of discount on convertible notes payable, and non-cash interest accrued on convertible notes payable, and increased by a net change in operating assets and liabilities of $1,244,821.

Cash Flows from Investing Activities

Investing activities during the six months ended June 30, 2015 provided $7,528,036 of cash, reflecting $7,819,762 provided by the sale of money market investments offset by $291,726 for the purchase of equipment. This compares to the six months ended June 30, 2014, when investing activities provided $5,251,076, reflecting $5,532,109 in proceeds from the sales of money market investments, offset by $281,033 for the purchase of equipment.

Cash Flows from Financing Activities

Financing activities provided $2,155,264 of cash during the six months ended June 30, 2015, including $2,278,948 from the exercise of stock options and warrants offset by $123,684 of cash used to satisfy the related income and payroll tax withholding amounts for our chief executive officer related to option exercises. Financing activities provided $7,987,808 of cash during the six months ended June 30, 2014, reflecting the issuance of $7,578,977 of common stock at $7.00 per share to new investors and $408,831 from stock option exercises.

Since our inception, we have generated limited revenues from the sale of products and have financed our operations primarily through the issuance of common stock, convertible debt (which has been converted into common stock), and grants from government agencies and other institutions.  Our initial public offering (“IPO”) has provided us with sufficient financial resources to fund our operations for a period in excess of the next twelve months. Although our objective is to increase revenues from product sales within the next two years, as well as to reduce the related cost of sales, in an amount sufficient to reach operating and cash flow breakeven levels, there can be no assurances that we will be successful in this regard. We currently anticipate that we will need to raise additional debt and/or equity capital in the next 12 to 18 months. 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.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

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 June 30, 2015, our cash equivalents consisted solely of money market funds.

Exchange Rate Sensitivity

In the first six months of 2015, approximately 40% of our revenue was denominated in U.S. dollars, 57% in Euros, and 3% in Canadian dollars. In the same time period, the 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 and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2014. 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. Based on the evaluation of our disclosure controls and procedures as of December 31, 2014, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

During the three months ended June 30, 2015, no changes occurred with respect to our internal control over financial reporting that materially affected, or are reasonably likely to materially affect, internal control over financial reporting.

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.

PART II-OTHER INFORMATION

Item 1.       Legal Proceedings

Ten oppositions have been filed by a third-party in the European Patent Office, each challenging the validity of a European patent owned or exclusively licensed by the Company. The outcome of the challenges is not certain, however, if successful, they may affect the Company's ability to block competitors from utilizing some of its patented technology in Europe. Management of the Company does not believe a successful challenge will have a material effect on its ability to manufacture and sell its products, or otherwise have a material effect on its operations.

The Company may be party to litigation arising in the ordinary course of business. It is management's opinion that the outcome of such matters will not have a material effect on the Company's financial statements.

Item 1A.    Risk Factors

We incorporate herein by reference the risk factors included in our Annual Report on Form 10-K, which we filed with the Securities and Exchange Commission on March 17, 2015.

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

On November 18, 2014, we sold 4,025,000 shares of common stock in our IPO, including 525,000 shares sold upon exercise of the underwriter's over-allotment option pursuant to a registration statement (File No. 333-198073) that we initially filed with the Securities and Exchange Commission in August 2014. Our net proceeds totaled approximately $34.2 million, after offering costs of approximately $5.0 million, including approximately $2.9 million in fair value of warrants and shares of common stock issued in connection with the underwriting and other services rendered for the IPO. In addition to funding our ongoing business operations, we expect to invest the proceeds of the IPO in our business to expand sales and marketing efforts, enhance our current Argus II product, gain regulatory approvals for additional indications, and continue research and development into next generation technology. Through June 30, 2015, approximately $11.2 million of net proceeds from the offering were used to fund ongoing business operations. None of the proceeds were used for construction of plant, building and facilities, the purchase of real estate, or the acquisition of any business.

During the six months ended 30, 2015, the Company issued 136,056 shares of common stock in connection with the exercise of warrants for cash with a per share exercise price of $5.00. The Company relied on the exemption provided by Section 4(a)(2) of the Securities Act of 1933 to issue the shares of common stock inasmuch as the warrant holders were accredited investors and there was no form of general solicitation or general advertising relating to the offer.

On January 1, 2015, the Company’s Chief Executive officer exercised options expiring on that date to purchase 59,063 shares of common stock at an exercise price of $4.75 per share. Based on a closing market price of the Company’s common stock of $10.26 on December 31, 2014, the Chief Executive Officer paid the aggregate exercise price by tendering 27,344 shares of common stock that he owned. To satisfy the $123,684 of income and payroll tax withholding amounts related to the transaction he surrendered 12,055 shares of common stock.

Item 3.      Defaults upon Senior Securities

Not applicable

Item 4.      Mine Safety Disclosures

Not applicable.

Item 5.      Other Information

Not applicable.

Item 6.      Exhibits

EXHIBIT INDEX

*          Included herein.

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

SIGNATURES

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