UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

[X]QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THESECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended:             SeptemberJune 30, 20162017

 

[  ]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: 000-51030

 

TearLab Corporation

(Exact name of registrant as

specified in its charter)

 

Delaware

 

59 343 4771

(State or other jurisdiction of

of incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

9980 Huennekens Street., Suite 100, San Diego, CA 92121

(Address of principal executive offices)

 

(858) 455-6006

(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant (1) 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 Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).

Yes [X] No [  ]

 

Indicate by check mark whether 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.

 

Large accelerated filer [  ]Accelerated filer [  ]

Non-accelerated filer [  ] (Do not check if a smaller reporting company)Smaller reporting company [X]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act): Yes [  ] No [X]

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 53,601,9905,742,453 as of October 31, 2016.August 7, 2017.

 

 

 

 
 

 

PART I.FINANCIAL INFORMATION 
   
Item 1.Financial Statements (Unaudited)4
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations20
Item 3.Quantitative and Qualitative Disclosures about Market Risk2827
Item 4.Controls and Procedures28
   
PART II.OTHER INFORMATION 
   
Item 1.Legal Proceedings2928
Item 1A.Risk Factors3029
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds42
Item 3.Defaults Upon Senior Securities42
Item 4.Mine Safety Disclosures42
Item 5.Other Information42
Item 6.Exhibits4342

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains forward-looking statements relating to future events and our future performance within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “pursue,” “potential” and similar expressions intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to future events, future results, and future economic conditions in general and statements about:

 

Our ability to continue as a going concern;
The adequacy of our funding and our forecast of the period of time through which our financial resources will be adequate to support our operations;
Our future strategy, structure, and business prospects;
prospects, and the ability to identify and execute any strategic alternatives;
Our ability to obtain additional financing for working capital on acceptable terms and in a timely manner;
The planned commercialization of our current product;
Our ability to expand into next generation products;

Our ability to meet the financial covenants under our credit facilities;
Use of cash, cash needs and ability to raise capital;
The size and growth of the potential markets for our product and technology;
The effect of our strategy to streamline our organization and lower our costs;

The adequacy of current, and the development of new distributor, reseller, and supplier relationships, and our efforts to expand relationships with distributors and resellers in additional countries;
Our anticipated expansion of United States and international sales and operations;
Our ability to obtain and protect our intellectual property and proprietary rights;
The results of our clinical trials;

Our ability to maintain reimbursement of our product and support our pricing strategies;
Our plan to continue to develop and execute our conference and podium strategy to ensure visibility and evidence-based positioning of the TearLab® Osmolarity System among eye care professionals;
Our ability to attract and retain a sufficient number of scientists, clinicians, sales personnel and other key personnel with extensive experience in medical technology, who are in short supply;
Our beliefs about our employee relations; and
Our efforts to assist our customers in obtaining their CLIA waiver or providing them with support from certified professionals
professionals; and

Our ability to remain listed on the The NASDAQ Capital Market.

 

These statements involve known and unknown risks, uncertainties and other factors,including the risks described in Part II, Item 1A. of this Quarterly Report on Form 10-Q, which may cause our actual results, performance or achievements to be materially different from any future results, performances, time frames or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements. Information regarding market and industry statistics contained in this Quarterly Report on Form 10-Q is included based on information available to us that we believe is accurate. It is generally based on academic and other publications that are not produced for purposes of securities offerings or economic analysis. We have not reviewed or included data from all sources and cannot assure you of the accuracy of the market and industry data we have included.

 

Unless the context indicates or requires otherwise, in this Quarterly Report on Form 10-Q, references to the “Company” shall mean TearLab Corporation or TearLab Corp. and its subsidiaries. References to “$” or “dollars” shall mean U.S. dollars unless otherwise indicated.

TearLab Corporation

 

PART I.FINANCIAL INFORMATION
  
ITEM 1.FINANCIAL STATEMENTS (Unaudited)

TearLab Corporation

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(expressed in thousands of U.S. dollars except number of shares)

(Unaudited)

 September 30, 2016 December 31, 2015  June 30, 2017 December 31, 2016 
        
ASSETS                
Current assets                
Cash $17,548  $13,838  $10,235  $15,471 
Accounts receivable, net  2,407   3,021   2,127   2,279 
Inventory  3,404   3,972   2,880   3,193 
Prepaid expenses and other current assets  837   790   1,092   1,226 
Total current assets  24,196   21,621   16,334   22,169 
                
Fixed assets, net  4,713   5,352   3,723   4,178 
Intangible assets, net  234   1,197   29   60 
Other non-current assets  331   181   99   220 
Total assets $29,474  $28,351  $20,185  $26,627 
                
LIABILITIES AND STOCKHOLDERS’ DEFICIT                
Current liabilities                
Accounts payable $1,865  $2,292  $2,987  $1,858 
Accrued liabilities  3,233   5,047   3,236   3,958 
Deferred rent  110   114   60   83 
Obligations under warrants  -   29 
Total current liabilities  5,208   7,482   6,283   5,899 
                
Long-term debt  25,990   24,859   27,371   26,449 
                
Total liabilities  31,198   32,341   33,654   32,348 
                
Exchange right  -   250 
Commitments and contingencies (Note8)        
Commitments and contingencies (Note 8)        
                
Stockholders’ deficit                
Capital stock                
Preferred Stock, $0.001 par value, 10,000,000 authorized, 2,764 and 0 issued and outstanding at September 30, 2016 and December 31, 2015, respectively  1,911    
Common stock, $0.001 par value, 95,000,000 and 65,000,000 authorized, 53,601,990 and 33,760,904 issued and outstanding at September 30, 2016 and December 31, 2015, respectively  54   34 
Preferred Stock, $0.001 par value, 10,000,000 authorized, 0 and 2,764 issued and outstanding at June 30, 2017 and December 31, 2016, respectively  -   - 
Common stock, $0.001 par value, 9,500,000 authorized, 5,735,732 and 5,360,198 issued and outstanding at June 30, 2017 and December 31, 2016, respectively  6   5 
Additional paid-in capital  504,679   488,514   507,548   506,982 
Accumulated deficit  (508,368)  (492,788)  (521,023)  (512,708)
Total stockholders’ deficit  (1,724)  (4,240)  (13,469)  (5,721)
Total liabilities and stockholders’ deficit $29,474  $28,351  $20,185  $26,627 

 

See accompanying notes to interim condensed consolidated financial statements

 

5
 

 

TearLab Corporation

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(expressed in thousands of U.S. dollars except shares and per share amounts)

(Unaudited)

 

 Three months ended 
 Three months ended  June 30, 
 September 30,  2017 2016 
 2016 2015      
Revenue                
Product sales $6,463  $5,522  $6,229  $5,428 
Reader equipment rentals  760   1,090   785   1,475 
Total revenue  7,223   6,612   7,014   6,903 
Cost of goods sold                
Cost of goods sold (excluding amortization of intangible assets)  2,564   2,827   2,682   2,465 
Cost of goods sold - reader equipment depreciation  527   467   446   555 
Gross profit  4,132   3,318   3,886   3,883 
Operating expenses                
Sales and marketing  3,109   4,589   3,304   3,364 
Clinical, regulatory and research & development  1,007   1,796   1,110   661 
General and administrative  2,598   4,087   2,309   2,960 
Amortization of intangible assets  359   389   -   304 
Total operating expenses  7,073   10,861   6,723   7,289 
Loss from operations  (2,941)  (7,543)  (2,837)  (3,406)
Other income (expense)                
Interest income (expense)  (1,037)  (502)  (1,048)  (1,046)
Changes in fair value of warrant obligations  -   17   -   2 
Other, net  (4)  (36)  (9)  106 
Total other income (expense)  (1,041)  (521)  (1,057)  (938)
Net loss and comprehensive loss $(3,982) $(8,064) $(3,894) $(4,344)
Weighted average shares outstanding - basic  53,348,908   33,728,931 
Net loss per share – basic $(0.07) $(0.24)
Weighted average shares outstanding - diluted  53,348,908   33,774,324 
Net loss per share – diluted $(0.07) $(0.24)
Weighted average shares outstanding - basic and fully diluted  5,731,293   4,484,925 
Net loss per share – basic and fully diluted $(0.68) $(0.97)

See accompanying notes to interim condensed consolidated financial statements

 

6
 

 

TearLab Corporation

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(expressed in thousands of U.S. dollars except shares and per share amounts)

(Unaudited)

 

 Six months ended 
 Nine months ended  June 30, 
 September 30,  2017 2016 
 2016 2015      
Revenue                
Product sales $17,393  $14,534  $12,357  $10,930 
Reader equipment rentals  3,500   3,830   1,358   2,740 
Total revenue  20,893   18,364   13,715   13,670 
Cost of goods sold                
Cost of goods sold (excluding amortization of intangible assets)  7,569   8,073   5,224   5,005 
Cost of goods sold - reader equipment depreciation  1,635   1,216   912   1,109 
Gross profit  11,689   9,075   7,579   7,556 
Operating expenses                
Sales and marketing  11,109   14,932   6,636   8,000 
Clinical, regulatory and research & development  2,805   4,911   2,675   1,799 
General and administrative  9,490   11,382   4,496   6,891 
Amortization of intangible assets  966   1,166   -   608 
Total operating expenses  24,370   32,391   13,807   17,298 
Loss from operations  (12,681)  (23,316)  (6,228)  (9,742)
Other income (expense)                
Interest income (expense)  (2,967)  (1,178)
Interest inome (expense)  (2,076)  (1,929)
Changes in fair value of warrant obligations  29   133   -   29 
Other, net  40   58   (11)  44 
Total other income (expense)  (2,898)  (987)  (2,087)  (1,856)
Net loss and comprehensive loss $(15,579) $(24,303) $(8,315) $(11,598)
Weighted average shares outstanding - basic  44,042,032   33,676,917 
Net loss per share – basic $(0.35) $(0.72)
Weighted average shares outstanding - diluted  44,042,032   33,723,678 
Net loss per share – diluted $(0.35) $(0.72)
Weighted average shares outstanding - basic and fully diluted  5,551,334   3,933,746 
Net loss per share – basic and fully diluted $(1.50) $(2.95)

See accompanying notes to interim condensed consolidated financial statements

 

7
 

 

TearLab Corporation

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(expressed in thousands of U.S. dollars)

(Unaudited)

 

 Six months ended 
 Nine months ended  June 30, 
 September 30,  2017  2016 
 2016 2015      
OPERATING ACTIVITIES                
Net loss for the period $(15,579) $(24,303) $(8,315) $(11,598)
Adjustments to reconcile net loss to cash used in operating activities:                
Stock-based compensation  2,103   3,218   535   1,524 
Depreciation of fixed assets  1,816   1,431   1,026   1,236 
Amortization of intangible assets  966   1,166   30   644 
Gain on disposal of subsidiary  (75)  -   -   (75)
Changes in fair value of warrant obligations  (29)  (133)  -   (29)
Deferred interest on long-term debt  1,104   395   612   688 
Amortization of debt discount  187   48   310   136 
Changes in operating assets and liabilities:                
Accounts receivable, net  614   129   152   763 
Inventory  568   (1,061)  313   665 
Prepaid expenses and other assets  (70)  (56)  134   (335)
Other non-current assets  (157)  (26)  121   (71)
Accounts payable  (328)  938   1,129   85 
Accrued liabilities  (1,819)  244   (722)  (2,049)
Deferred rent/revenue  3   (50)  (23)  (9)
Cash used in operating activities  (10,696)  (18,060)  (4,698)  (8,425)
                
INVESTING ACTIVITIES                
Additions to fixed assets, net of proceeds  (1,177)  (2,423)
(Gain) loss on disposal of fixed assets  -   (3)
Additions to fixed assets  (570)  (844)
Cash used in investing activities  (1,177)  (2,426)  (570)  (844)
                
FINANCING ACTIVITIES                
Proceeds from the issuance of equity instruments  15,457   - 
Proceeds from the issuance of term loan  -   14,544 
Proceeds from the issuance equity instruments  -   15,457 
Repurchase of fractional shares upon reverse stock split  (3)  - 
Proceeds from the issuance of employee stock purchase plan shares  126   99   35   84 
Proceeds from the exercise of stock options  -   99 
Cash provided by financing activities  15,583   14,742   32   15,541 
                
Increase (decrease) in cash and cash equivalents during the period  3,710   (5,744)  (5,236)  6,272 
Cash, beginning of period  13,838   16,338   15,471   13,838 
Cash, end of period $17,548  $10,594  $10,235  $20,110 
        
Supplemental cash flow information        
Cash paid for interest $1,155  $1,110 

 

See accompanying notes to interim condensed consolidated financial statements

8
 

 

TearLab Corporation

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(expressed in thousands of U.S. dollars except as otherwise stated)

(Unaudited)

 

1. BASIS OF PRESENTATION

 

Nature of Operations

 

TearLab Corporation (formerly OccuLogix, Inc.) (“TearLab” or the “Company”), a Delaware corporation, is an ophthalmic device company that is commercializing a proprietary in vitro diagnostic tear testing platform, the TearLab® test for dry eye disease, or DED, which enables eye care practitioners to test for highly sensitive and specific biomarkers using nanoliters of tear film at the point-of-care.

 

The accompanying condensed consolidated financial statementsCondensed Consolidated Financial Statements include the accounts of the Company and all of its wholly owned subsidiaries. On April 8, 2016, OcuHub Holdings, Inc., a wholly-owned subsidiary of the Company, completed the sale of 10,167.5 units of OcuHub LLC (“OcuHub”), reducing OcuHub Holdings, Inc.’s ownership in OcuHub to 10.5% on a fully-diluted basis. Prior to the sale, the accounts of OcuHub were included in the condensed consolidated financial statements.Condensed Consolidated Financial Statements. In the three and ninesix months ended SeptemberJune 30, 2016, the Company recorded a gain on the sale of OcuHub of $75, included in Other income (expense) on the Condensed Consolidated StatementStatements of Operations and Comprehensive Loss. Intercompany accounts and transactions have been eliminated on consolidation.

 

On February 23, 2017, the Company’s stockholders authorized the board of directors to implement a reverse stock split, along with a corresponding reduction in the number of shares authorized. On February 27, 2017, the Company effected a 1-for-10 reverse stock split of its common stock. All common stock share amounts and prices per share of common stock in these Condensed Consolidated Financial Statements have been retroactively adjusted to reflect the reverse stock split.

Liquidity and Going Concern

 

The accompanying condensed consolidated financial statementsCondensed Consolidated Financial Statements have been prepared on the going concern basis, which assumes that the Company will continue to operate as a going concern and which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. However, theThe Company has sustained substantial losses of $15,579$8,315 and $11,598 for the ninesix months ended SeptemberJune 30, 2017 and 2016, respectively. Based on the Company’s current rate of cash consumption, the Company estimates it will need additional capital by the first quarter of 2018 and $33,229its prospects for the year ended December 31, 2015.obtaining that capital are uncertain. The Company has implemented plansmay be able to mitigate conditionsraise either additional debt financing or additional equity financing. However, the Company can make no assurances that it will be able to raise the required additional capital, either through debt or equity financing, on acceptable terms or at all. Unless the Company succeeds in raising additional capital or significantly reduces the cash consumed in the operations of the Company, the Company anticipates that it will be unable to continue operations through the end of the first quarter of 2018 without violating an existing covenant on the Term Loan Agreement (defined below). As a result of the Company’s historical losses and financial condition, there is substantial doubt about the Company’s ability to continue as a going concern. In February 2016, the Company underwent a strategic restructuring, including a staff reduction of 54 positions, designed to improve the Company’s overall cost structure. In April 2016, the Company finalized the divestment of OcuHub. In May 2016, the Company issued a combination of common stock, preferred stock, and warrants to purchase common stock for net proceeds of $15,457.  The Company’s working capital surplus at September 30, 2016, was $18,988 which represents a $4,849 increase from its working capital at December 31, 2015. Management believes the combination of restructuring the Company’s cost structure, the cash provided by the equity capital raise and anticipated cash flows provided by the sale of products, will be sufficient to fund the Company’s cash requirements for at least the next twelve months. The accompanying condensed consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

TearLab Corporation

 

2. SIGNIFICANT ACCOUNTING POLICIES

 

The consolidated balance sheetCondensed Consolidated Balance Sheet at December 31, 20152016 has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by accounting principles generally accepted in the United States (“U.S. GAAP”) for complete financial statements. These unaudited interim condensed consolidated financial statementsCondensed Consolidated Financial Statements have been prepared using significant accounting policies that are consistent with the policies used in preparing the Company’s audited consolidated financial statements for the year ended December 31, 2015.2016. The audited financial statements for the year ended December 31, 2015,2016, filed with the SEC with ourthe Company’s annual report on Form 10-K on March 9, 201610, 2017 include a summary of our significant accounting policies and should be read in conjunction with this Form 10-Q. Management believes that all adjustments necessary for the fair presentation of results, consisting of normally recurring items, have been included in the unaudited condensed consolidated financial statementsCondensed Consolidated Financial Statements for the interim periods presented.

TearLab Corporation

 

Use of Estimates

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. The principal areas of judgment relate to revenue and inventory reserves, allowance for doubtful accounts, impairment of long-lived and intangible assets, and the fair value of stock options and warrants.

 

Revenue recognition

 

Revenue is recognized when all four of the following criteria are met: (i) persuasive evidence that an arrangement exists; (ii) delivery of the products has occurred; (iii) the selling price is fixed or determinable; and (iv) collectability is reasonably assured. The Company’s timing of revenue recognition is impacted by factors such as passage of title, payments and customer acceptance. Amounts received in excess of revenue recognizable are deferred.

 

The Company sells its proprietaryTearLab® Osmolarity System and related test cards to external customers, who are primarily eye care professionals, for use in osmolarity testing procedures. Revenue is primarily derived from the sale of disposable test cards. Products are generally shipped from a distribution and warehousing facility located in San Diego, California. The Company’s sales are currently direct to customers in the United States and to distributors in the rest of the world.

 

The Company enters into contracts where revenue is derived either from agreements whereby the customer is provided the right to use the TearLab® Osmolarity System (reader equipment) at no separate cost to the customer in consideration for a minimum or implied purchase commitment of disposable test cards over the related contract term (“Use(referred to as either “Use Agreements”, “Masters Agreements” or “Flex Agreements”), or from agreements with separate sales of multiple deliverables, such as the reader equipment and disposable test cards (“Purchase(referred to as “Purchase Agreements”).

 

Purchase commitments for Use Agreements and Flex Agreements are expressed in the agreement for a specified period of time (generally one to three years). The purchase commitment for Masters Agreements is implied for large physician practices with an expectation of purchasing certain levels of test cards. The Company recovers the cost of providing the reader equipment in the amount charged for disposable test cards. These agreements are treated as operating leases as collectability of the minimum lease payments is not reasonably predictable at the outset of the arrangement. Accordingly, revenue is recognized over the defined contract term as disposable test cards are shipped. Revenue under such agreements is allocated between the lease of the reader equipment and the sale of the disposables based upon each component’s relative fair value. When reader equipment is placed with a customer at no separate cost, the Company retains title to the equipment and it remains capitalized on the Company’s Condensed Consolidated Balance Sheet as equipment classified within fixed assets, net. The equipment is depreciated on a straight-line basis once shipped to a customer location over its estimated useful life and depreciation expense is included in cost of goods sold within the Condensed Consolidated Statements of Operations and Comprehensive Loss.

TearLab Corporation

 

Revenue recognition for Purchase Agreements with multiple deliverables is based on the individual units of accounting determined to exist in the contract. A delivered item is considered a separate unit of accounting when the delivered item has value to the customer on a stand-alone basis. Items are considered to have stand-alone value when they are sold separately by any vendor or when the customer could resell the item on a stand-alone basis. Considering that test cards are essential to the operation of a TearLab reader, there is no alternative vendor for the test cards and no indication that a secondary market for the TearLab readers is established, the deliverables under the contracts do not meet criteria for separation under the multiple-element arrangements guidance. Consideration is allocated at the inception of the contract to all deliverables based on their relative selling price as determined by the selling price of similar individual items on a stand-alone basis. The Company recognizes revenue for each of the elements only when it determines that all applicable recognition criteria have been met.

 

Although the Company typically has a no return policy for its products, the Company has established a reserve for product sales that contain an implicit right of return. The Company reserves for estimated returns or refunds by reducing revenuerevenues at the time of shipment based on historical experience. The reserve of $16$12 and $67$13 as of SeptemberJune 30, 20162017 and December 31, 2015,2016, respectively, has reduced revenue and is included in accounts receivable.

 

Recent accounting pronouncements

 

In August 2016, the Financial Accountings Standards Board (the “FASB”) issued Accounting Standards Update No. 2016-15, Statement of Cash Flows (“ASU 2016-35”2016-15”), to reduce diversity in practice of how certain transactions are classified in the statement of cash flows. ASU 2016-15 is effective for fiscal and interim periods beginning after December 15, 2017. The Company is currently evaluating the impact the adoption of the new standard will have on its financial statements.

 

In March 2016, the FASB issued Accounting Standards Update No. 2016-09 Improvement to Employee Share-Based Payment AccountingCompensation–Stock Compensation (“ASU 2016-09”), which involves severalrequires that excess tax benefits and tax deficiencies be recorded in the income statement as a reduction or increase of income taxes when an award vests. It also requires excess tax benefits to be classified as an operating activity in the statement of cash flows. In addition, it simplifies other aspects of accounting for share-based payment transactions, including income tax consequences, classification of awards as liabilities or equity,that permit repurchase to satisfy statutory tax withholding requirements and classificationsclassification of tax payments on behalf of employees on the statement of cash flows. ASU 2016-09 is effective for fiscal and interim periods beginning after December 15, 2016. The Company is currently evaluatingadopted this guidance in the impactfirst quarter 2017, and it did not have a material effect on the adoption of the new standard will have on its financial statements.Company’s Condensed Consolidated Financial Statements.

 

In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (“ASU 2016-02”). ASU 2016-02 establishes a right-of-use model that requires a lessee to record an asset and liability on the balance sheet for all leases with terms longer than twelve months. ASU 2016-02 is effective for fiscal years and interim periods beginning after December 15, 2018. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The Company is currently evaluating the impact of the new standard on its financial statements.

 

In July 2015, the FASB issued Accounting Standards Update No. 2015-11, Inventory-Simplifying the Measurement of Inventory (“ASU 2015-11”). ASU 2015-11 became effective January 1, 2017. Under ASU 2015-11, the Company measures inventory at the lower of cost or net realizable value, where net realizable value is defined as the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. ASU 2015-11 was applied prospectively beginning January 1, 2017. The change to lower of cost or net realizable value had no impact on the Company’s financial statements.

TearLab Corporation

In May 2014, the FASB issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”), which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. Early application is not permitted. On April 1, 2015, the FASB voted to propose a deferral of the effective date of the standard by one year which would result in the new standard being effective for the Company at the beginning of its first quarter of fiscal year 2018. The Company has not yet completedexpects to finalize its assessment of the impact of the new standard including possible transition alternatives,on its financial statements in 2017 so it can implement ASU 2014-09, on a modified retrospective basis, in the first quarter of 2018. The Company does not expect the guidance to have a material impact on the amounts reported in the financial statements, but it will require enhanced footnote disclosures regarding the Company’s financial statements.

TearLab Corporationrecognition of revenue.

 

3. BALANCE SHEET DETAILS

 

Accounts receivable

 

 September 30, 2016 December 31, 2015  June 30, 2017  December 31, 2016 
        
Trade receivables $2,928  $3,610  $2,638  $2,928 
        
Allowance for doubtful accounts  (521)  (589)  (511)  (649)
 $2,407  $3,021  $2,127  $2,279 

 

Inventory

 

Inventory is recorded at the lower of cost or marketnet realizable value and consists of finished goods. Inventory is accounted for on a first-in, first-out basis.

 

 June 30, 2017  December 31, 2016 
 September 30, 2016 December 31, 2015      
Finished goods $3,439  $4,002  $2,899  $3,210 
Inventory reserves  (35)  (30)  (19)  (17)
 $3,404  $3,972  $2,880  $3,193 

 

The Company evaluates inventory for estimated excess quantities and obsolescence, based on expected future sales levels and projections of future demand, and establishes inventory reserves for obsolete and excess inventories. In addition, the Company assesses the impact of changing technology and market conditions. The Company has entered into a long-termlong term purchase commitment to buy the test cards from MiniFAB (Aust) Pty Ltd (“MiniFAB”)(Note 8). The purchase commitment contains required minimum purchases based on periodic forecasts submitted to MiniFab, but the purchase commitment can fluctuate up or down depending on the Company’s forecast of future demand. As part of its analysis of excess or obsolete inventories, the Company considers future annual minimum purchases, estimated future usage and the expiry dating of the cards to determine if any inventory reserve is needed.

11 

TearLab Corporation

 

Prepaid expenses and other current assets

  September 30, 2016  December 31, 2015 
Prepaid trade shows  125  $246 
Prepaid insurance  170   87 
Manufacturing deposits  282   154 
Subscriptions  103   128 
Other fees and services  125   146 
Other current assets  32   29 
  $837  $790 

12
  June 30, 2017  December 31, 2016 
Prepaid trade shows  296  $217 
Prepaid insurance  193   326 
Manufacturing deposits  282   282 
Subscriptions  243   297 
Other fees and services  78   66 
Other current assets  -   38 
  $1,092  $1,226 

 

TearLab Corporation

Fixed assets

 

 September 30, 2016 December 31, 2015  June 30, 2017 December 31, 2016 
Capitalized TearLab equipment $9,311  $8,349  $9,278  $9,095 
Leasehold improvements  60   61   60   60 
Computer equipment and software  930   1,023   920   932 
Furniture and office equipment  272   278   272   271 
Medical equipment  499   431   781   500 
 $11,072  $10,142  $11,311  $10,858 
Less accumulated depreciation  (6,359)  (4,790)  (7,588)  (6,680)
 $4,713  $5,352  $3,723  $4,178 

 

Depreciation expense was $1,816$1,026 and $1,431$1,236 for the ninesix months ended SeptemberJune 30, 20162017 and 2015,2016, respectively, and $580$505 and $538,$617, respectively, for the three months ended SeptemberJune 30, 20162017 and 2015.2016.

 

Accrued liabilities

 

 September 30, 2016 December 31, 2015  June 30, 2017 December 31, 2016 
Due to professionals $68  $256  $296  $81 
Due to employees and directors  1,691   2,130   1,274   2,200 
Sales and use tax liabilities  168   231   262   247 
Royalty liability  464   753   427   854 
Warranty  124   94   129   124 
Other  718   1,583   848   452 
 $3,233  $5,047  $3,236  $3,958 

 

4. INTANGIBLE ASSETS

 

The Company’s intangible assets consist primarily of the value of TearLab® Technology acquired in the acquisition of TearLab Research, Inc., a wholly-owned subsidiary of the Company.Company and a prescriber list. The TearLab Technology, which consists of a disposable lab card and card reader, supported by an array of patents and patent applications that are either held or in-licensed by the Company.  The TearLab Technology is beingCompany, included in amortization of intangibles line item in the Condensed Consolidated Statements of Operations and Comprehensive Loss, was fully amortized using the straight-line method over an estimated useful life of 10 years.in November 2016. Amortization expense for the three months ended SeptemberJune 30, 2017 and 2016 was $15 and 2015 was $359 and $389,$329, respectively. Amortization expense for the ninesix months ended SeptemberJune 30, 2017 and 2016 was $30 and 2015 was $966 and $1,166,$644, respectively.

TearLab Corporation

 

Intangible assets subject to amortization consist of the following:

 

  Remaining
Useful Life
  Gross Value at  Accumulated  Net Book
Value at
 
  (Years)  September 30, 2016  Amortization  September 30, 2016 
TearLab® technology  1  $12,172  $(12,016) $156 
Patents and trademarks  2   271   (238)  33 
Prescriber list  2   90   (45)  45 
Total     $12,533  $(12,299) $234 

TearLab Corporation

  Remaining  Gross     Net Book 
  Useful Life  Value at  Accumulated  Value at 
  (Years)  June 30, 2017  Amortization  June 30, 2017 
TearLab® technology  0  $12,172  $(12,172) $- 
Patents and trademarks  1   271   (253)  18 
Prescriber list  1   90   (79)  11 
Total     $12,533  $(12,504) $29 

 

        Net Book 
 Gross Value at Accumulated Net Book Value at     Gross Value at Accumulated Value at 
 December 31,2015 Amortization December 31,2015     December 31, 2016  Amortization  December 31, 2016 
TearLab® technology $12,172  $(11,106) $1,066   0  $12,172  $(12,172) $- 
Patents and trademarks  268   (216)  52   1   271   (245)  26 
Prescriber list  90   (11)  79   1   90   (56)  34 
Total $12,530  $(11,333) $1,197      $12,533  $(12,473) $60 

 

The estimated amortization expense for the intangible assets for the remainder of 20162017 and thereafter is as follows:

 

  Amortization 
  of intangible 
  assets 
Remainder of 2016 $175 
2017  59 
  $234 
  Amortization 
  of intangible 
  assets 
Remainder of 2017 $19 
Thereafter  10 
  $29 

 

5.TERM5. TERM LOAN

 

On March 4, 2015, the Company executed a term loan agreement (the “Term Loan Agreement”) with CRG LP and certain of its affiliate funds (“CRG”) as lenders providing the Company with access of up to $35,000 under the arrangement. The Company received $15,000 in gross proceeds under the arrangement on March 4, 2015, and an additional $10,000 on October 6, 2015. The Term Loan Agreement matures on DecemberMarch 31, 20202021 and bears interest at 13% per annum, with quarterly payments of interest only for the first four years. While interest on the loan is accrued at 13% per annum, the Company may elect to make interest-only payments at 8.5% per annum. The unpaid interest of 4.5% is added to the principal of the loan and is subject to additional accrued interest (“PIK interest”). The accrued interest can be deferred and paid together with the principal in the fifth and sixth years.

 

13 

TearLab Corporation

As part of the amended Term Loan Agreement, and funding of the second tranche, CRG received 350,00035,000 warrants dated as of October 6, 2015 to purchase common shares of the Company at a price of $5.00$50.00 per share (the “CRG Warrants”). The CRG Warrants have a five-year life. The CRG Warrants are classified as equity on the Condensed Consolidated Balance SheetSheets as of December 31, 2015June 30, 2017 and September 30, 2016. The CRG Warrants were valued at their issuance date using the Black-Scholes Merton model. The related reduction of the long-term debt will be amortized over the life of the debt.

 

The loan is collateralized by all assets of the Company. Additionally, the terms of the Term Loan Agreement contain various affirmative and negative covenants agreed to by the Company. Among them, the Company must attain minimum certain annual revenue and minimum cash threshold levels. On April 7, 2016, the Company amended the Term Loan Agreement to change the required minimum revenue levels. The amended minimum revenue is $27,000 for 2016, $31,000 for 2017, $36,000 for 2018, $45,000 for 2019 and $55,000 for 2020. The minimum cash balance required is $5,000 subject to certain conditions. The amendment also reduced the exercise price of the CRG Warrants from $5.00$50.00 per share to $1.50$15.00 per share and the Company issued CRG additional warrants to purchase 350,00035,000 common shares of the Company’s stock at $1.50$15.00 per share, which expire 5 years after issuance. See Note 6 for further discussion of the CRG Warrants.

TearLab Corporation

 

If the Company does not have annual revenue greater or equal to the annual revenue covenant in a calendar year, the Company will have the right within 90 days of the end of the respective calendar year to raise subordinated debt or equity (the “CRG Equity Cure”) equal to twice the difference between the annual revenue and the revenue covenant, with the total proceeds from this financing to be used to reduce the principal of the Term Loan Agreement. In the event of a default, the Company may be required to repay any outstanding amounts earlier than anticipated, and CRG may foreclose on their security interest in the Company’s assets.

 

At SeptemberJune 30, 2016,2017, the Company was in compliance with all of the covenants.

 

As part of the amended Term Loan Agreement, on the earlier of the maturity date or the date the term loan is paid off in full, the Company will pay a facility fee equal to 6.5% of the aggregate principal amount of the loan, excluding accrued PIK interest (the “Facility Fee”). The Facility Fee is being accrued to interest expense using the effective interest method.

 

The Company incurred financing and legal fees associated with the debt of $606, which were recorded as a direct discount to the debt and are being amortized using the effective interest method. The Company presents the debt issuance costs related to the recognized debt liability on the Condensed Consolidated Balance SheetSheets as a reduction of the liability.

 

The Term Loan Agreement provided for prepayment fees of 5% of the outstanding balance of the loan if the loan was repaid prior to March 31, 2016. The prepayment fee is reduced 1% per year for each subsequent year until maturity.

 

The following is a summary of the Term Loan Agreement as of SeptemberJune 30, 20162017 and related maturities of outstanding principal:

 

Prinicpal balance outstanding $25,000  $25,000 
PIK interest  1,572   2,488 
Facility fee  214   536 
less discount on term loan:        
deferred financing fees, net  (458)  (376)
detachable warrants, net  (338)  (277)
Total term loan $25,990  $27,371 

 

Principal due for each of the next 5 years and in the aggregate:

Remaining 2016 $- 
2017  - 
2018  - 
2019  13,393 
2020  13,393 
Total principal due  26,786 
Less: discount on term loan  (796)
Total term loan $25,990 

TearLab Corporation

2017 $- 
2018  - 
2019  10,308 
2020  13,744 
2021  3,972 
Total principal due  28,024 
Less: discount on term loan  (653)
Total term loan $27,371 

 

6. STOCKHOLDERS’ EQUITY

 

(a) Authorized share capital

On February 23, 2017, the Company’s stockholders authorized the board of directors to implement a reverse stock split, along with a corresponding reduction in the number of shares authorized. On February 27, 2017, the Company effected a 1-for-10 reverse stock split of its common stock. All common stock share amounts and prices per share of common stock have been retroactively adjusted to reflect the reverse stock split.

 

On June 24, 2016, the Company’s stockholders approved an amendment to the Company’s certificate of incorporation to increase the total number of authorized shares of common stock of the Company to 95,000,0009,500,000 from 65,000,000.6,500,000. Each share of common stock has a par value of $0.001 per share. The total number of authorized shares of preferred stock of the Company is 10,000,000. Each share of preferred stock has a par value of $0.001 per share.

 

(b) Common and preferred shares

 

On May 9, 2016 the Company issued 18,610,9001,861,090 shares of common stock, 3,291.8 shares of Series A Convertible Preferred Stock (“Preferred Stock”) and Series A warrants to purchase 11,500,0001,150,000 shares of common stock (“Series A Warrants”) for gross proceeds of $17,250, less issuance costs of $1,793. TheAdditionally, the Company granted the placement agent warrants to purchase 103,500 shares of common stock with an exercise price of $11.25 per share. All the Preferred Stock is convertible, subject to certain limitations,converted into an aggregate of 4,389,100438,910 shares of common stock contains no voting rights, participates in any common stock dividends, and is treated as if converted upon any ordinary liquidation event.prior to June 30, 2017. The common stock, the Series A Convertible Preferred Stock, and the Series A Warrants are all included in equity in the Company’s Condensed Consolidated Balance Sheets as of SeptemberJune 30, 2017 and December 31, 2016. The net proceeds were allocated to common stock, Preferred Stock, and Series A Warrants based on their relative fair values, as follows:

 

Common stock $9,632 
Preferred stock  2,275 
Series A warrants  3,550 
Net proceeds $15,457 

 

15 

On August 2, 2016, 527.5 shares of Series A Convertible Preferred stock were converted into 703,334 shares of commons stock.

TearLab Corporation

 

(c) Stock incentive plan

 

The Company has a stock incentive plan,On June 23, 2017 the Company’s stockholders approved an amendment to the 2002 Stock Incentive Plan (the “Stock Incentive Plan”), under which up to 7,200,000 optionsincrease the total number of shares reserved for issuance to 1,070,000 from 720,000. Stock Incentive Plan shares are available for grant to employees, directors and consultants. OptionsShares granted under the Stock Incentive Plan may be either incentive stock options, or non-statutory stock options.options, stock appreciation rights, restricted stock or restricted share units. Under the terms of the Stock Incentive Plan, the exercise price per share for an incentive stock option shall not be less than the fair market value of a share of stock on the effective date of grant and the exercise price per share for non-statutory stock options shall not be less than 85% of the fair market value of a share of stock on the date of grant. No option granted to a holder of more than 10% of the Company’s common stock shall have an exercise price per share less than 110% of the fair market value of a share of stock on the effective date of grant.

 

Options granted are typically service-based options. Generally, options expire 10 years after the date of grant. No incentive stock options granted to a 10% owner optionee shall be exercisable after the expiration of five years after the effective date of grant of such option, no option has been granted to a prospective employee, prospective consultant or prospective director prior to the date on which such person commences service, and with the exception of an option granted to an officer, director or consultant, no incentive option shall become exercisable at a rate less than 20% per annum over a period of five years from the effective date of grant of such option unless otherwise approved by the Board.

 

TearLab Corporation

The Company accounts for stock-based compensation under the authoritative guidance which requires that share-basedShare-based payment transactions with employees beare recognized in the financial statements based on their fair value and recognized as compensation expense over the vesting period. The amount of expense recognized during the period is affected by subjective assumptions, including: estimates of the Company’s future volatility, the expected term for its stock options, option exercise behavior, the number of options expected to ultimately vest, and the timing of vesting for the Company’s share-based awards.

 

The following table sets forth the total stock-based compensation expense resulting from stock options and the employee stock purchase plan included in the Company’s condensed consolidated statementsCondensed Consolidated Statements of operationsOperations and comprehensive lossComprehensive Loss (in thousands):

 

 Three months ended Six months ended 
 Three months ended Nine months ended  June 30, June 30, 
 September 30, September 30,  2017 2016 2017 2016 
 2016 2015 2016 2015          
Sales and marketing $196  $412  $617  $1,311  $111  $253  $257  $421 
Clinical, regulatory and research and development  50   99   279   320   41   114   84   230 
General and administrative  333   476   1,207   1,587   94   444   194   873 
Stock-based compensation expense before income taxes $579  $987  $2,103  $3,218  $246  $811  $535  $1,524 

 

(d) Employee Stock Purchase Plan

 

In July 2014, the Company’s Board of Directors adopted the 2014 Employee Stock Purchase Plan (the “ESPP”) which was approved by the Company’s stockholders in June 2014 at the Company’s Annual Meeting of Stockholders. A total of 671,50067,150 shares of the Company’s common stock are reserved for issuance under the plan, which permits eligible employees to purchase common stock at a discount through payroll deductions.

 

The price at which stock is purchased under the ESPP is equal to 90% of the fair market value of the common stock on the first or the last day of the offering period, whichever is lower. Generally, each offering under the ESPP will be for a period of six months as determined by the Company’s Board of Directors. Employees may invest up to 20% of their gross compensation through payroll deductions. In no event may an employee purchaseinvest more than $25 worth of stock in the plan during each calendar year or purchase more than 5,000500 shares per offering period. During the three months ended SeptemberJune 30, 20162017 and 2015,2016, the Company recorded $2 and $27$4, of expense, respectively, under the ESPP. During the ninesix months ended SeptemberJune 30, 20162017 and 2015,2016, the Company recorded $8$5 and $66$7 of expense, respectively, under the ESPP. During the ninesix months ended SeptemberJune 30, 20162017 and 2015,2016, the Company issued 141,0527,512 and 54,2116,774 shares of common stock, respectively, under the ESPP. On July 3, 2017, the Company issued an additional 6,721 shares of common stock under the ESPP.

TearLab Corporation

 

(e) Warrants

On June 30, 2011, the Company closed a private placement financing in which 3,846,154 shares of common stock and warrants (’’2011 Warrants’’) to purchase 3,846,154 shares of common stock for gross proceeds of approximately $7,000. The exercise price of the warrants was $1.86 per share. The 2011 Warrants expired on June 30, 2016. There were 219,604 of the 2011 Warrants that expired unexercised. Prior to their expiration, the 2011 Warrants were recorded as a liability on the Company’s balance sheet and remeasured each period using the Black-Scholes Merton option-pricing model. There were no exercises of 2011 Warrants during the nine months ended September 30, 2016 or 2015. The liability for the 2011 Warrants outstanding as of December 31, 2015 had a value of $29. The value of the 2011 Warrants outstanding as of December 31, 2015 was recorded as a Change in fair value of warrant obligations in the Consolidated Statements of Operations and Comprehensive Loss during the nine months ended September 30, 2016, reflecting the expiration of the instruments and the associated liability.

TearLab Corporation

 

On October 8, 2015, as part of the second amendment to the Term Loan Agreement and funding of the $10,000 tranche, CRG received warrants to purchase 350,00035,000 common shares in the Company at a price of $5.00$50.00 per share (the “CRG Warrants”). The CRG Warrants are exercisable any time prior to October 8, 2020. The CRG Warrants are classified as equity on the Condensed Consolidated Balance Sheets as of June 30, 2017 and December 31, 2015 and September 30, 2016. The CRG Warrants were valued at $290 upon issuance using the Black-Scholes Merton model assuming volatility of 73%, an expected life of 5.0 years, a risk-free interest rate of 1.71%, and 0% dividend yield. No CRG Warrants were exercised during the ninesix months ended SeptemberJune 30, 2017 or 2016.

 

On April 8, 2016, the Company further amended its Term Loan Agreement. As part of the amendment, the exercise price of the CRG Warrants was changed to allow the holder to purchase 350,00035,000 common shares in the Company at a price of $1.50$15.00 per share and CRG was issued an additional 350,00035,000 warrants to purchase common shares at an exercise price of $1.50$15.00 (the “2016 CRG Warrants”). The modification to the terms of the CRG Warrants resulted in a change in fair value of $54 which was included as interest expense for the nine months ended September 30, 2016.expense. The change in fair value was calculated using the Black-Scholes Merton model with both exercise prices, assuming volatility of 76%, an expected life of 4.5 years, a risk-free interest rate of 1.06%, and 0% dividend yield. The 2016 CRG Warrants were valued at $106 upon issuance using the Black-Scholes Merton model assuming volatility of 76%, an expected life of 5.0 years, a risk-free interest rate of 1.30% and 0% dividend yield.

 

On May 9, 2016, the Company issued Series A Warrants to purchase 11,500,0001,253,500 shares of common stock for $1.125$11.25 per common share attached to shares of common and Series A Convertible Preferred Stock issued on the same date. The Series A Warrants can be exercised after May 9, 2017 (the “Initial Exercise Date”) and expire 5 years after the Initial Exercise Date. Fair value of the Series A Warrants, for purposes of allocating the net proceeds of the equity offering, was determined using the Black-Scholes Merton model assuming volatility of 76%, an expected life of 6.0 years, a risk-free interest rate of 1.30%, and 0% dividend yield.

 

(e)(f) Exchange Right

 

In August 2014, the Company sold membership units in OcuHub LLC, a Delaware limited liability company, which was a wholly owned subsidiary of TearLab Corporation at the time, in exchange for 2% ownership of OcuHub LLC. In connection with the sale of the membership units, the new members received an exchange right allowing the units to be exchanged upon written notice and during a specified exchange window for shares in the Company’s common stock. On March 31, 2016, the members exchanged the ownership interest in OcuHub LLC for 385,800 shares of the Company’s common stock.

 

7. NET INCOME (LOSS) PER SHARE

 

Basic income (loss)earnings per share (“EPS”) excludes dilutive securities and is calculatedcomputed by dividing net income (loss)loss available to common stockholders by the weighted average number of shares of common shares and vested restricted stock units outstanding. Diluted income (loss) per share is computed by dividing net income (loss), less any dilutive amounts recorded during the periodoutstanding for the change in fair value of warrant liabilities, byyear. Diluted EPS reflects the weighted average number ofpotential dilution that could occur if securities or other contracts to issue common shares and vested restricted stock units outstandingwere exercised or converted and the weighted average numberresulting additional shares are dilutive because their inclusion decreases the amount of dilutive common stock equivalents, from stock options, warrants, and non-vested restricted stock units. Common stock equivalents are only included in the diluted earnings per share calculation when their effect is dilutive. Diluted loss per share for the three and nine months ended September 30, 2015 includes the dilutive impact of the gain recorded from the Company’s June 30, 2011 warrants.EPS.

17 

 

TearLab Corporation

 

The following securities were not included in the calculation of diluted earnings per share because their effects were anti-dilutive:

 

 Three and nine months ended 
(in thousands of shares) September 30,  As of June 30, 
 2016 2015  2017 2016 
Stock options  7,276   6,471   707   740 
Warrants  12,200   74   1,324   1,220 
ESPP shares  69   35   7   7 
Convertible preferred shares  3,686   - 
Exchange rights  -   124 
                
Total  23,231   6,704   2,038   1,967 

 

8. COMMITMENTS AND CONTINGENCIES

Commitments

The Company has commitments relating to operating leases recognized on a straight line basis over the term of the lease for rental of office space and equipment from unrelated parties, expiring at various times through June 30, 2018. The Company leases office facilities under an operating lease agreement. The initial term of the lease is five years and includes periodic rent increases and a renewal option.

Effective October 1, 2006, the Company entered into a patent license and royalty agreement with the University of California San Diego to obtain a second exclusive license to make, use, sell, offer for sale, and import existing TearLab technology. The Company is required to make royalty payments of $35 or 5.5% of gross sales per year, whichever is higher. Additionally, the Company is required to pay a royalty of 30% of any sublicense fees it receives prior to receiving FDA approval and 25% of any sub-license fees it receives after FDA approval.

Future minimum royalty payments under this agreement as of June 30, 2017 are as follows:

2017 $35 
2018  35 
2019  35 
2020  35 
2021  35 
Thereafter  210 
Total $385 

On March 12, 2003, the Company entered into a patent license and royalty agreement with the University of California San Diego to obtain an exclusive license to make, use, sell, offer for sale, and import TearLab technology in development. Starting in 2009, the Company was required to make minimum royalty payments of $35 or 5.5% of gross sales per year, whichever is higher. However, if this new technology is combined with existing technology, the maximum royalty payable on the sale of the combined products would be 5.5% of gross sales per year. As the new technology is currently in development, there is no revenue and the minimum royalty payment of $35 is applicable.

TearLab Corporation

Future minimum royalty payments under this agreement as of June 30, 2017 are as follows:

2017 $35 
2018  35 
2019  35 
2020  35 
2021  35 
Thereafter  210 
Total $385 

 

On March 7, 2016, the Company, through its subsidiary, TearLab Research, Inc., entered into a supply and development agreement (“Supply Agreement”) with MiniFAB (Aust) Pty Ltd (“MiniFAB”). The agreement is an exclusive supply agreement through June 2021, which will provide 16% savings onfor the purchase and delivery of individual osmolarity test cards following a transition period to account for ending inventory at December 31, 2015 and other elements ofwith the prior agreement. The savings consist of lower prices for the purchase of the test cards and for freight costs to shipborne by MiniFab. The Company has the cards to the Company’s distribution facility. Thebenefit of a lower purchase price that will remain in place until the earlier of, the date that the Company reaches an annual volume of 4.5 million test cards andor March 31, 2018. TheCertain savings from freight costs will remain in place throughout the agreement. The Supply Agreement requires, that, in any given 6 calendar months, the Company must place aggregate purchase orders equal to at least 50% of the orders forecasted for that 6 month period at its onset. The Supply Agreement can be extended by either party for a term of five years with the option for the Company to buyout the exclusive supply provision during any extended term. This Supply Agreement replaces the July 2011 agreement between MiniFAB and the Company.

 

In April 2014, the Company guaranteed a marketing agreement entered into by OcuHub LLC, which was a wholly-owned subsidiary of the Company at the time.OcuHub. The underlying marketing agreement calls for an annual marketing fee of $100, with payments due quarterly through March 31, 2019. ShouldIf OcuHub LLC failfails to perform its obligations under the terms of the marketing agreement, the Company couldwould be required to make the $25 quarterly payments, through the March 31, 2019 initial term of the agreement. The Company has not accrued for any liability under the guarantee.

 

In the normal course of business, the Company enters into purchase obligations for future goods and services needed for the operations of the business. Such commitments are not in excess of expected requirements and are not reasonably likely to result in performance penalties or payments that would have a material adverse effect on the Company’s liquidity.

9. SUBSEQUENT EVENTSContingencies

 

On October 13, 2016,During the ordinary course of business activities, the Company may be contingently liable for litigation and Physician Recommended Nutriceuticals (“PRN”) entered into a cooperative marketing agreement (the “Marketing Agreement”) wherebyparty to claims. Currently the Company and PRN will jointly promote PRN’s proprietary omega-3 formulations. PRN’s marketed omega-3 formulations have been shownis not party to reduce osmolarity levels in dry eye patients utilizing the TearLab Osmolarity System as an objective assessment.any material litigation.

 

19 

The Marketing Agreement has a 30 month term. Upon successful completion of a six month demonstration period, the Company will earn a marketing fee based on a percentage of revenue of the promoted products that varies over both the term of the agreement and by different customer channels. The Marketing Agreement contains an option for mutual renewal by both parties, non-compete provisions and provisions for termination upon a change of control.

TearLab Corporation

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes, included in Item 1 of this Report. Unless otherwise specified, all dollar amounts are U.S. dollars.

 

Overview

 

We are anin-vitro diagnostic company based in San Diego, California. We have commercialized a proprietary tear testing platform, the TearLab® Osmolarity System that enables eye care practitioners to test for highly sensitive and specific biomarkers using nanoliters of tear film at the point-of-care. Our first product measures tear film osmolarity for the diagnosis of Dry Eye Disease, or DED.

 

We develop technologies to enable eye care practitioners to test a wide range of biomarkers (chemistries, metabolites, genes and proteins) at the point-of-care. Commercializing and further development of that tear testing platform is now the focus of our business.

 

Our product, the TearLab® Osmolarity System, enables the rapid measurement of tear osmolarity in the doctor’s office. Osmolarity is a quantitative and highly specific biomarker that has been shown to assist in the diagnosis and disease management of DED. Based on the Beaver Dam Offspring Study (2005-2008), prevalence of DED was 14.5% across an adult population aged 21-84, impacting 17.9% of women and 10.5% of men in the study. Thestudy.The innovation of the TearLab® Osmolarity System is its ability to precisely and rapidly measure osmolarity in nanoliter volumes of tear samples, using a highly efficient and novel tear collection system at the point of care. Historically, eye care researchers have relied on expensive instruments to perform tear biomarker analysis. In addition to their cost, these conventional systems are slow, highly variable in their measurement readings, and not categorized as waived by the United States Food and Drug Administration, or the FDA, under regulations promulgated under the Clinical Laboratory Improvement Amendments, or CLIA.

 

The TearLab® Osmolarity System consists of the following three components: (1) the TearLab disposable, which is a single-use microfluidic microchip; (2) the TearLab Pen, which is a hand-held device that interfaces with the TearLab disposable; and (3) the TearLab Reader, which is a small desktop unit that allows for the docking of the TearLab Pen and provides a quantitative reading for the operator.

 

We enter into contracts where revenue is derived either from agreements whereby the customer is provided the right to use the TearLab® Osmolarity System at no separate cost to the customer in consideration for a minimum or implied purchase commitment of disposable test cards over the related contract term (referred to as either “Use Agreements”, “Masters Agreements” or “Flex Agreements”), or from agreements with separate sales of the reader equipment and disposable test cards (“Purchase Agreements”). Purchase commitments for Use Agreements and Flex Agreements are expressed in the agreement for a specified period of time (generally one to three years). The purchase commitment for Masters Agreements is implied for large physician practices with an expectation of purchasing certain levels of test cards.

 

In October 2008, the TearLab® Osmolarity System received CE mark approval, clearing the way for sales in the European Union and all countries recognizing the CE mark. While our current focus is on developing our business in the United States, we do have agreements with numerous distributors for distribution of the TearLab® Osmolarity System in Canada, Mexico, South America, Europe, Asia and Australia.

 

Recent Developments

On October 13, 2016 the Company entered into a cooperative marketing agreement (the “Marketing Agreement)” with Physician Recommended Nutriceuticals (“PRN”). Pursuant to the Marketing Agreement, PRN and the Company will jointly promote PRN’s proprietary omega-3 formulations, including Dry Eye Omega Benefits®. The Marketing Agreement is expected to initiate in November 2016 and has a 30 month term with an option for mutual renewals by both parties.

20
 

 

TearLab Corporation

 

RESULTS OF OPERATIONS

 

Revenue, Cost of Sales and Gross MarginProfit

Revenue

 

 Three months ended  Nine months ended 
(in thousands) September 30,  September 30,  Three months ended
June 30,
     Six months ended
June 30,
    
 2016 2015 Change 2016 2015 Change  2017 2016 Change 2017 2016 Change 
                          
TearLab revenue $7,223  $6,612  $611  $20,893  $18,364  $2,529  $7,014  $6,903  $111  $13,715  $13,670  $45 
TearLab – cost of sales  3,091   3,294   (203)  9,204   9,289   (85)  3,128   3,020   108   6,136   6,114   22 
TearLab gross profit  4,132   3,318   814   11,689   9,075   2,614   3,886   3,883   3   7,579   7,556   23 
Gross profit percentage  57%  50%      56%  49%      55%  56%      55%  55%    

 

TearLab revenue consists of sales of the TearLab® Osmolarity System, which is a hand-held tear film test for the measurement of tear osmolarity, a quantitative and highly specific biomarker that has shown to correlate with DED.

 

The TearLab Osmolarity System consists of the following three components: (1) the TearLab disposable, which is a single-use microfluidic lab test card; (2) the TearLab pen, which is a hand-held device that interfaces with the TearLab disposable; and (3) the TearLab reader, which is a small desktop unit that allows for the docking of the TearLab disposable and the TearLab pen and provides a quantitative reading for the operator.

TearLab revenue increased by $0.6$0.1 million or 9%2% for the three months ended SeptemberJune 30, 20162017 compared to the three months ended SeptemberJune 30, 2015.2016. The increase is the result of an increase in test card sales of $0.3 million when compared to the three months ended September 30, 2015 because of higher test card volume associatedrevenue from a joint marketing agreement with more accounts on our FLEX card program. We also had an increase of $0.3 million in reader sales when compared to the three months ended September 30, 2015, attributable to converting selected accounts to a purchase model.PRN Physicians Recommended Nutriceuticals (“PRN”). The agreement with PRN was terminated effective June 23, 2017.

 

TearLab revenue increased by $2.5 million or 14%was flat for the ninesix months ended SeptemberJune 30, 20162017 as compared to the prior year period. The increase is driven from an increase in test card sales volume representing $1.7 millionsix months ended June 30, 2016, as new business acquired during the first six months of the total increaseyear offset a slight decline in utilization of existing customers. Revenue from the prior year period as well as an increase in reader revenue of $0.9 million. The increase in test card volumeour agreement with PRN was offset by a decline in the current year is duevolume of test cards sold to existing customers that we experienced in part to bringing in new accounts, increasing utilization in our FLEX accounts and converting existing accounts to our FLEX card program.the first quarter of 2017.

 

Cost of Sales

 

TearLab cost of sales includes costsdepreciation of goods sold,reader systems, warranty, and royalty costs. Our cost of goods sold consists primarily of costs for the manufacture of the TearLab Osmolarity System, including the costs we incur for the purchase of component parts from our suppliers, applicable freight and shipping costs, fees related to warehousing and logistics inventory management.

 

TearLab costs of sales for the three months ended SeptemberJune 30, 2016 decreased $0.22017 increased $0.1 million, or 6%4%, compared to the three months ended SeptemberJune 30, 2015. The per unit cost2016. Costs of sales was higher due to some one-time savings onrealized in the 2016 period from a renegotiated agreement with our test cards were offset in part by higher sales volumes.card supplier.

 

For the ninesix months ended SeptemberJune 30, 2016,2017, TearLab cost of sales decreased by $0.1 million or 1% overwas flat when compared to the same prior year fiscal period. Per unit cost savings on our test cards were offset by the higher volume of test card sales, higher royalty costs associated with higher sales volume and increased depreciation costs associated with more active readers in place.

TearLab Corporation

 

Gross Profit

 

TearLab gross profit for the three months ended SeptemberJune 30, 2016 increased by $0.8 million or 25%2017 was flat when compared to the three months ended SeptemberJune 30, 2015. The increase is due to a combination of higher sales volume and improved gross margin.2016. The gross marginprofit percentage of revenue for the three months ended SeptemberJune 30, 20162017 was 57%55% as compared to 50%56% for the three months ended SeptemberJune 30, 2015. Gross margin improvement2016. The gross profit percentage for the three months ended SeptemberJune 30, 20162017 was lower due in part to the conversion and addition of our more productive Flex accounts, improvements onone-time savings realized in the per unit cost of2016 period from a renegotiated agreement with our test cards, and a two year moratorium, beginning January 1, 2016, on the 2.3% medical device excise tax on sales in the United States.card supplier.

 

TearLab gross marginprofit for the ninesix months ended SeptemberJune 30, 2016 increased by $2.6 million or 29%2017 was flat compared to the same prior year fiscal period. The increase is due to higher sales volume and improved gross margin. The gross marginGross profit as a percentage of revenue for both the ninesix month period ending SeptemberJune 30, 2017 and 2016 was 56% as compared to 49% for the prior year fiscal period. The improvement in gross margin is attributable to an increase in the make-up of accounts under the FLEX program and the moratorium in the United States on the medical device excise tax.55%.

 

Operating Expenses

 

 Three months ended  Nine months ended 
(in thousands) September 30,  September 30,  Three months ended
June 30,
     Six months ended
June 30,
    
 2016 2015 Change 2016 2015 Change  2017 2016 Change 2017 2016 Change 
                          
Sales and marketing $3,109  $4,589  $(1,480) $11,109  $14,932  $(3,823) $3,304  $3,364  $(60) $6,636  $8,000  $(1,364)
Clinical, regulatory and research and development  1,007   1,796   (789)  2,805   4,911   (2,106)  1,110   661   449   2,675   1,799   876 
General and administrative  2,598   4,087   (1,489)  9,490   11,382   (1,892)  2,309   2,960   (651)  4,496   6,891   (2,395)
Amortization of intangible assets  359   389   (30)  966   1,166   (200)  -   304   (304)  -   608   (608)
Operating expenses $7,073  $10,861  $(3,788) $24,370  $32,391  $(8,021) $6,723  $7,289  $(566) $13,807  $17,298  $(3,491)

 

Sales and Marketing Expense

 

Sales and marketing expenses decreased by $1.5$0.1 million or 32%2% in the three months ended SeptemberJune 30, 2016,2017, as compared with the comparable period in fiscal 2015.2016. The reduction in sales and marketing expenses is attributabledue to cost savings from our February 2016 organizational restructuringthe timing and $0.2 millioncosts of cost savings from the divestiture of our OcuHub subsidiary.sales training events.

 

Sales and marketing expenses decreased by $3.8$1.4 million or 26%17% for the ninesix months ended SeptemberJune 30, 20162017 compared to the same prior year fiscal period. The decrease in sales and marketing expenses is attributable to cost savings from our February 2016 organizational restructuring.

 

Clinical, Regulatory and Research and Development Expenses

 

Total clinical, regulatory and research and development expenses decreased $0.8increased $0.4 million or 44%68% in the three months ended SeptemberJune 30, 20162017 as compared with the three months ended SeptemberJune 30, 2015.2016. The decreaseincrease when compared to the prior fiscal period was due to a decreasean increase in external product development costs related to the timingdevelopment and testing of our next generationthe TearLab Discovery™ platform which we expect to file with the U.S. Food and Drug Administration in the second half of diagnostic products.2017.

 

Total clinical, regulatory and research and development expenses decreased $2.1increased $0.9 million or 43%49% during the ninesix months ended SeptemberJune 30, 20162017 as compared with the comparable prior year fiscal period. The decreaseincrease is due to a decreasean increase in external product development costs related to the timingdevelopment and testing of our next generation of diagnostic products.the TearLab Discovery™ platform.

TearLab Corporation

General and Administrative Expenses

 

Total general and administrative expenses decreased $1.5$0.7 million or 36%22% in the three months ended SeptemberJune 30, 20162017 as compared with the three months ended SeptemberJune 30, 2015.2016. The decrease when compared to the prior fiscal period was primarily attributabledue to $0.6 millionreduced equity compensation in the current period related to the vesting of reduced professional services costs and $0.6 millioncertain grants of cost savings from the divestiture of our OcuHub subsidiary.options.

 

Total general and administrative expenses decreased $1.9$2.4 million or 17%35% for the ninesix months ended SeptemberJune 30, 20162017 as compared with the comparable prior year fiscal period. The decrease is due to the decrease in equity compensation in 2017, lower legal and professional service fees in 2017 because of a planned common stock offering we withdrew in the first quarter of 2016 and operating cost savings of $1.1 million from the divestiture of our OcuHub subsidiary and approximately $0.4 million of reduced professional services costs.in April 2016.

 

Amortization of Intangible Assets

 

Amortization expense of intangible assets for the three and six months ended SeptemberJune 30, 2017 was $0, compared to $0.3 million and $0.6 million in the three and six months ended June 30, 2016, respectively. The TearLab® technology fully amortized during 2016 so there was $359,000, as compared to the $389,000 in the prior year fiscal period. Amortizationno comparable expense of intangible assets for the nine months ended September 30, 2016 was $966,000 compared to $1,166,000 for the nine month period ended September 30, 2015. The decrease of $30,000 and $200,000 for the three and ninesix month periods, respectively, resulted from the amortization of certain OcuHub related intangibles in the prior year fiscal period.period ended June 30, 2017.

 

Other Income (Expense)

 

 Three Months Ended  Nine Months Ended 
(in thousands) September 30,  September 30,  Three Months Ended
June 30,
     Six Months Ended
June 30,
    
 2016 2015 Change 2016 2015 Change  2017 2016 Change 2017 2016 Change 
                          
Interest income (expense) $(1,037) $(502) $(535) $(2,967) $(1,178) $(1,789) $(1,048) $(1,046) $(2) $(2,076) $(1,929) $(147)
Changes in fair value of warrant obligations  -   17   (17)  29   133   (104)  -   2   (2)  -   29   (29)
Other (net )  (4)  (36)  32   40   58   (18)  (9)  106   (115)  (11)  44   (55)
Other income $(1,041) $(521) $(520) $(2,898) $(987) $(1,911) $(1,057) $(938) $(119) $(2,087) $(1,856) $(231)

 

Interest Income (Expense)

 

Interest expense for the three months ended SeptemberJune 30, 20162017 and 20152016 was from the interest for the CRG term loan. Interest expense increasedwas flat for the three and nine months ended SeptemberJune 30, 20162017 when compared to the same periodsperiod in the previous fiscal year and increased 8% for the six months ended June 30, 2017 when compared to the same period in the previous year on larger average balances of long-term debt outstanding during the period, and becauseoffset in part by $54,000 charged to interest expense in 2016 from the revaluation of the impactCRG Warrants generated by an amendment to the exercise price of the detachable warrants issued to the lendersCRG Warrants in October 2015 on interest expense.April 2016.

 

Changes in Fair Value of Warrants Obligations

 

The Company records outstanding warrants considered liabilities at fair value at the end of each reporting period, resulting in an adjustment to the warrant obligations, with any gain or loss recorded in earnings for the applicable period. The Company had no warrants with liability treatment outstanding during the three and six months ended SeptemberJune 30, 20162017, and, accordingly, had no associated fair value adjustment during the period. TheFor the three and six month periods ended June 30, 2016, the Company recorded income related to a decrease in the fair value of warrant obligations of $17,000 for the three months ended September 30, 2015. The Company recorded income related to a decrease in the fair value of warrant obligations of$2,000 and $29,000 and $133,000 for the nine months ended September 30, 2016 and 2015, respectively.

23 

TearLab Corporation

 

Other (net)

 

Other income (loss) for the three and ninesix months ended SeptemberJune 30, 20162017 consists primarily of foreign exchange transaction gains and losses, based on fluctuations of the Company’s foreign denominated currencies. The nine months ended September 30, 2016 also includes a $75,000 gain on the sale of OcuHub.currencies and trade payables. For the three and ninesix months ended SeptemberJune 30, 20152016 other income (loss) consists primarily of foreign exchange transaction gains and losses. The nine months ended September 30, 2015 also includeslosses and a one-time gain of $147,000$75,000 on the cancellation of an accrued liability related to the acquisition of the net assetssale of OcuHub.

 

Liquidity and Capital Resources

 

(in thousands) September 30, 2016 December 31, 2015 Change  June 30, 2017 December 31, 2016 Change 
Cash and cash equivalents $17,548  $13,838  $3,710  $10,235  $15,471  $(5,236)
Percentage of total assets  59.5%  48.8%      50.7%  58.1%    
Working capital $18,988  $14,139  $4,849  $10,051  $16,270  $(6,219)

 

Financial Condition

 

Based on our current rate of cash consumption, we estimate we will need additional capital during the first quarter of 2018 and our prospects for obtaining that capital are uncertain. The Company has sustained substantial losses of $15.6 million formay be able to raise either additional debt financing or additional equity financing. However, the nine months ended September 30, 2016 and $33.2 million forCompany can make no assurances that it will be able to raise the year ended December 31, 2015 and has a history of net cash usedrequired additional capital, either through debt or equity financing, on acceptable terms or at all. Unless we succeed in its operations. We have introduced steps toraising additional capital or we significantly reduce the rate of our use of cash in our operations, including a strategic restructuring in February 2016 and the divestiture of our OcuHub subsidiary. These steps contributed to reduce the net cash used in operating activities to $2.3 million and $10.7 million for the three and nine months ended September 30, 2016, respectively, compared to $4.3 and $18.1 million for the three and nine months ended September 30, 2015. On May 9, 2016, we issued a combination of common stock, preferred stock and warrants to purchase common stock in exchange for $15.5 million in cash (net of fees and expenses) to provide cash for future operating needs. The proceeds from the issuance of equity and the reduced amount of cash used in operations for the current three month period resulted in a working capital surplus of $19.0 million at September 30, 2016 which represents a $4.8 million increase from our working capital at December 31, 2015. We believe these steps takenconsumed in the first halfoperations of fiscal 2016, including the expectationCompany, we anticipate that we will continuebe unable to generate cash from the sales of our product, will provide us the liquidity necessary to supportcontinue our operations for at leastthrough the next 12 months.end of the first quarter of 2018, without violating an existing covenant on the Term Loan Agreement. As a result of the Company’s historical losses and financial condition, there is substantial doubt about the Company’s ability to continue as a going concern.

Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties. Actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including but not limited to:

 

whether and to what extent government and third-party payers agree to reimburse the TearLab® Osmolarity System;
  
whether eye care professionals engage in the process of obtaining their CLIA waiver certification;
our ability to retain current utilization levels from existing customers and add new customers;
   
 the costs and timing of building the infrastructure to market and sell the TearLab® Osmolarity System;
   
 the cost and results of continuing development of the TearLab® Osmolarity System and next generation products;
   
 the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and
   
 the effect of competing technological and market developments.

TearLab Corporation

 

At the present time, our only product is the TearLab Osmolarity System, and although we have received 510(k) approval from the FDA and a CLIA waiver approval from the FDA, at this time we do not know when we will generate revenue from the TearLab Osmolarity System in the United States sufficient to fully fund our operations. If events or circumstances occur such that we do not meet our plans to fund the business, we may be required to reduce operating expenses and reduce the planned levels of inventory and fixed assets which could have an adverse impact on our ability to achieve our intended business objectives.

TearLab Corporation

 

Indebtedness

On March 4, 2015, we executed the Term Loan Agreement with CRG as lenders providing us with access of up to $35.0 million under the Term Loan Agreement. We entered into a second amendment to the Term Loan Agreement with CRG on August 6, 2015. We received $15.0 million in gross proceeds under the Term Loan Agreement on March 4, 2015, and an additional $10.0 million on October 6, 2015. We were unable to access a third tranche of $10.0 million because we did not attain at least $38.0 million in twelve month revenue prior to June 30, 2016, as required to access the third tranche. We entered into a second amendment to the Term Loan Agreement with CRG on August 6, 2015. As part of the second amendment to the Term Loan Agreement and funding of the $10.0 million tranche, CRG received warrants to purchase 350,00035,000 common shares in the Company at a price of $5.00$50.00 per share. The warrants have a life of five years. On April 7, 2016, the Term Loan Agreement was further amended, under the fourth amendment, to change the required minimum revenue levels. In addition, the fourth amendment reduced the exercise price of the warrants CRG received under the second amendment to $15.00 per share and granted CRG additional warrants to purchase an additional 35,000 common shares in the Company at a price of $15.00 per share. The Term Loan Agreement has a term of six years and bears interest at 13% per annum, with quarterly payments of interest only for the first four years. At our option, during the first four years a portion of the interest payments amounting to a 4.5% per annum rate may be deferred and paid together with the principal in the fifth and sixth years.

On April 7, 2016, we further amended the Term Loan Agreement (the “Fourth Amendment”). The Fourth Amendment changes the required minimum revenue levels under the Term Loan Agreement to $27.0 million, $31.0 million, $36.0 million, $45.0 million and $55.0 million for the calendar years 2016, 2017, 2018, 2019 and 2020, respectively. In addition, the Fourth Amendment releases the guaranty and other obligations given by OcuHub LLC under the Term Loan Agreement. The Fourth Amendment also reduced the exercise price of the warrants to purchase 350,000 common shares in the Company issued to CRG from $5.00 per share to $1.50 per share and CRG received an additional 350,000 warrants to purchase common shares in the Company at an exercise price of $1.50 per share.

 

The Term Loan Agreement is collateralized by all our assets. Additionally, the terms of the Term Loan Agreement contain various affirmative and negative covenants. Among them, we must attain minimum certain annual revenue and minimum cash threshold levels. The minimum annual revenue threshold level required by the Term Loan Agreement for calendar year 2017 is $31.0 million. The minimum cash balance required is $5.0 million, subject to certain conditions.

 

If we do not have annual revenue greater or equal to the annual revenue covenant in a calendar year, we will have to raise subordinated debt or equity (the “CRG Equity Cure”) equal to twice the difference between the annual revenue and the revenue covenant, with the total proceeds from this financing to be used to reduce the principal of the Term Loan Agreement. In the event we do not achieve the minimum revenue threshold and cannot complete the CRG Equity Cure, we may be in default of the Term Loan Agreement. In the event of a default, we may be required to repay any outstanding amounts earlier than anticipated, and the lenders may foreclose on their security interest in our assets.

 

25

TearLab Corporation

Ongoing Sources and Uses of Cash

 

We anticipate that our cash on hand and cash generated from increased sales of the TearLab Osmolarity Systemrevenue will be sufficient to sustain our operations beyondinto the next 12 months.first quarter of 2018. In the first quarter of 2018, we will likely need to raise additional capital. We continually evaluate various financing possibilities but we typically expect our primary sourcesources of cash will be related to the collection of accounts receivable. Our accounts receivable collections will be impacted by our ability to grow our point-of-care revenue.

 

We expect our primary uses of cash will be to fund our costs of sales, operating expenses and pursuing and maintaining our patents and trademarks. In addition, dependent on available funds, we expect to expend cash to improve production capability of the TearLab test, to further improve the performance of the TearLab test, and to pursue next generation products using our lab-on-a-chip technology.

TearLab Corporation

 

Changes in Cash Flows

 

Cash Used in Operating Activities

 

Net cash used to fund our operating activities during the ninesix months ended SeptemberJune 30, 20162017 was $10.7$4.7 million compared to $18.1$8.4 million during the ninesix months ended SeptemberJune 30, 2015.2016. Net cash used in operating activities during the ninesix months ended SeptemberJune 30, 20162017 was less than our net loss of $15.6$8.3 million primarily due to the amortization of intangible assets, depreciation of fixed assets, stock-based compensation, interest deferred on our long-term debt and changes in the fair value of warrant obligations. Inobligations in the aggregate these non-cash items total $6.1 million. This was offset in part byof $2.5 million plus a $1.1 million net decreasesdecrease in our investment in working capital accounts during the nine months ended September 30, 2016 of $1.2 million.accounts. Net cash used in operating activities during the ninesix months ended SeptemberJune 30, 20152016 was less than our net loss of $24.3$11.6 million due to the amortization of intangible assets, depreciation of fixed assets, stock-based compensation, interest deferred on our long-term debt and changes in the fair value of warrant obligations in the aggregate total of $6.1$4.1 million andoffset in part by a $0.1$1.0 million net increase in working capital accounts.

 

The net change in working capital and non-current asset balances related to operations for the ninesix months ended SeptemberJune 30, 20162017 and 20152016 consists of the following:

  Nine Months Ended 
(in thousands) September 30, 
  2016  2015 
Changes in operating assets and liabilities:        
         
Accounts receivable, net $614  $129 
Inventory  568   (1,061)
Prepaid expenses and other assets  (70)  (56)
Other non-current assets  (157)  (26)
Accounts payable  (328)  938 
Accrued liabilities  (1,819)  244 
Deferred rent/revenue  3   (50)
  $(1,189) $118 

TearLab Corporation

 

Explanations of the more significant net changes in working capital and non-current asset balances are as follows:

 

  Six Months Ended 
 June 30, 
(in thousands) 2017  2016 
Changes in operating assets and liabilities:        
         
Accounts receivable, net $152  $763 
Inventory  313   665 
Prepaid expenses and other assets  134   (335)
Other non-current assets  121   (71)
Accounts payable  1,129   85 
Accrued liabilities  (722)  (2,049)
Deferred rent/revenue  (23)  (9)
  $1,104  $(951)

 Accounts receivable decreased in the ninesix months ended SeptemberJune 30, 20162017 because of improved collections on outstanding balances.
   
 Inventory decreased in the ninesix months ended SeptemberJune 30, 20162017 because of a combination of reduced levels of test card inventory on hand and more favorable pricing for the inventory on hand.
   
 AccruedAccounts payable and accrued liabilities had a decreasenet increase during the ninesix months ended SeptemberJune 30, 20162017 primarily because of the timing of the work performed and invoices received laterelating to the development of our next generation of products offset in December 2015 for professional services rendered, thepart by payment in 20162017 of amounts due to employees under the 20152016 incentive compensation program and the company’s overall reduction in spending.program.

 

Cash Used in Investing Activities

 

Net cash used in investing activities for the ninesix months ended SeptemberJune 30, 2017 and 2016 and 2015 was $1.2$0.6 million and $2.4$0.8 million respectively, to acquire fixed assets, primarily TearLab Osmolarity systems.

 

Cash Provided by Financing Activities

 

Net cash provided by financing activities during the ninesix months ended SeptemberJune 30, 2017 and 2016 was $15.6$32,000 and $15.5 million and was almost allrespectively, of proceeds from the issuance of equity. For the nine months ended September 30, 2015, net cash provided by financing activities of $14.7 million consisted primarily of $14.5 million of proceeds from the term loan.

TearLab Corporation

 

Off-Balance-Sheet Arrangements

 

As of SeptemberJune 30, 2016,2017, we did not have any material off-balance-sheet arrangements as defined in Item 303(1)(4)(ii) of SEC Regulation S-K.

 

Critical Accounting Policies and Estimates

 

Management’s discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statementsCondensed Consolidated Financial Statements which are prepared in accordance with accounting principles that are generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities, related disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. We continually evaluate our estimates and judgments, the most critical of which are those related to revenue recognition and inventory valuation. We base our estimates and judgments on historical experience and other factors that we believe to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known.

 

There were no significant changes during the ninethree months ended SeptemberJune 30, 20162017 to the items that we disclosed as our critical accounting policies and estimates in Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015.2016. For further clarification with regards to the Company’s specific policies for revenue recognition, see Note 2 of the Notes to the Unaudited Condensed Consolidated Financial Statements for the three and ninesix months ended SeptemberJune 30, 20162017 included in Item 1.

 

27

TearLab Corporation

Recent Accounting Pronouncements

 

For information on the recent accounting pronouncements impacting our business, see Note 2 of the Notes to the unaudited Condensed Consolidated Financial Statements for the three and ninesix months ended SeptemberJune 30, 20162017 included in Item 1.

ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

Currency Fluctuations and Exchange Risk

 

Our sales are denominated primarily in U.S. dollars with minimal sales in euros and pound sterling. Most of our expenses are denominated in U.S. dollars, however, some of the development work on new products is in Australian dollars and a minor portion of our other expenses are in Australian dollars, Canadian dollars euros and pounds sterling. We cannot predict any future trends in the exchange rate of the AustralianCanadian dollar, CanadianAustralian dollar, euro or pound sterling against the U.S. dollar. Any strengthening of the AustralianCanadian dollar, CanadianAustralian dollar, euro or pound sterling in relation to the U.S. dollar would increase the U.S. dollar cost of our operations, and affect our U.S. dollar measured results of operations. We maintain bank accounts in Canadian dollars to meet short term operating requirements. We do not engage in any hedging or other transactions intended to manage these risks. In the future, we may undertake hedging or other similar transactions or invest in market risk sensitive instruments if we determine that it is advisable to offset these risks.

TearLab Corporation

Interest Rate Risk

 

Our interest payments to CRG are based on a fixed contractual interest rate of 13%. A decrease in market interest rates would increase the fair value of our long-term debt.

ITEM 4.CONTROLS AND PROCEDURES.

 

ITEM 4.CONTROLS AND PROCEDURES.

(a)Disclosure Controls and Procedures.

(a)Disclosure Controls and Procedures.

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to the our management, including our chief executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefit of controls must be considered relative to their costs. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)). Based on that evaluation, our chief executive officer and chief financial officer concluded that, as at Septemberof June 30, 20162017 our disclosure controls and procedures were effective at the reasonable assurance level.

TearLab Corporation

(b)Changes in Internal Control over Financial Reporting.

(b)Changes in Internal Control over Financial Reporting.

 

During the thirdsecond quarter of 2016,2017, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II. OTHER INFORMATION

ITEM 1.LEGAL PROCEEDINGS.

 

ITEM 1. LEGAL PROCEEDINGS.

From time to time, we may be involved in various other claims and legal proceedings relating to claims arising out of our operations. We are not currently a party toaware of any legal proceedingsmaterial litigation involving us that in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.is outstanding, threatened or pending.

TearLab Corporation

 

ITEM 1A. RISK FACTORS.

 

Risks Relating to Our Financial Condition

 

We have limited working capital and a history of losses that raise substantial doubts as to whether we will be able to continue as a goinggoding concern.

 

We have prepared our consolidated financial statementsCondensed Consolidated Financial Statements on the basis that we would continue as a going concern. However, we have incurred losses in each year since our inception.inception and will need to raise additional capital prior to the end of the first quarter of 2018, and cannot assure you that we will be able to do so. We do not currently have any available borrowing under our term loan or credit facility.

 

Our consolidated financial statementsCondensed Consolidated Financial Statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary if we were not able to continue as a going concern. If we are unable to generate positive cash flows from operations, we would need to undertake a review of potential business alternatives, which may include, but are not limited to, a merger or sale of the company or ceasing operations and winding down the business.

 

We have incurred losses since inception and anticipate that we will incur continued losses for the foreseeable future.

 

We have incurred losses in each year since our inception. As of SeptemberJune 30, 2016,2017, we had an accumulated deficit of $508.4$521.0 million. Our losses have resulted primarily from expenses incurred in research and development of our product candidates from the former retina and glaucoma business divisions. We do not know when or if we will successfully commercialize the TearLab® Osmolarity System in the United States or in international markets. As a result, and because of the numerous risks and uncertainties facing us, it is difficult to provide the extent of any future losses or the time required to achieve profitability, if at all. Any failure to become and remain profitable would require us to undertake a review of the potential business alternatives discussed above.

 

We maywill need to raise additional capital at some point in the future if we do not achieve our business objectives.near future. Such capital, if needed, may not be available to us on reasonable terms, if at all, when or as we require additional funding. If we issue additional shares of our common stock or other securities that may be convertible into, or exercisable or exchangeable for, our common stock, our existing stockholders, would experience further dilution.

 

We may be requiredexpect that we will need to raise additional capital from timeprior to time in the future if we do not execute on our current business objectives and continue to grow our revenue at a rate sufficient to fund our operations with our current cash on hand.end of the first quarter of 2018. Such financings may involve the issuance of debt, equity and/or securities convertible into or exercisable or exchangeable for our equity securities. These financings may not be available to us on reasonable terms or at all when and as we require funding. Any failure to obtain additional working capital when required would have a material adverse effect on our business and financial condition, our ability to continue as a going concern and would be expected to result in a decline in our stock price. If we consummate such financings, the terms of such financings may adversely affect the interests of our existing stockholders. Any issuances of our common stock, preferred stock, or securities such as warrants or notes that are convertible into, exercisable or exchangeable for, our capital stock, would have a dilutive effect on the voting and economic interest of our existing stockholders.

TearLab Corporation

We may not be able to generate sufficient cash to service our indebtedness, which currently consists of our credit facility with CRG. We may not be able to satisfy our minimum revenue and cash covenants, as required by the CRG term loan. If our annual sales revenue levels do not meet or exceed the levels required by the CRG covenants, we will be required to raise additional equity or subordinated debt, with the proceeds paid to reduce the outstanding principal of the CRG term loan. This financing could dilute existing shareholders and impact the value of their investment.

TearLab Corporation

 

On March 4, 2015, we executed a term loan agreement with CRG as lenders which we refer to as the Term(the “Term Loan Agreement,Agreement”) providing us with access of up to $35.0 million under the Term Loan Agreement. We entered into an amendment of the Term Loan Agreement with CRG on August 6, 2015. We received $25.0 million in gross proceeds during 2015. We were unable to access a third tranche of $10.0 million because we did not attain at least $38.0 million in twelve-month sales revenue prior to June 30, 2016, as required to access the third tranche. We can make no assurance that we will be able to raise either additional debt financing or additional equity capital. There can be no assurances that there will be adequate financing available to us on acceptable terms or at all.

 

Our ability to make scheduled payments or to refinance our debt obligations depends on numerous factors, including the amount of our cash reserves and our actual and projected financial and operating performance. These amounts and our performance are subject to certain financial and business factors, as well as prevailing economic and competitive conditions, some of which may be beyond our control. We cannot assure you that we will maintain a level of cash reserves or cash flows from operating activities sufficient to permit us to pay the principal, premium, if any, and interest on our existing or future indebtedness. If our cash flows and capital resources are insufficient to fund our debt service obligations, we may be forced to reduce or delay capital expenditures, sell assets or operations, seek additional capital or restructure or refinance our indebtedness. We cannot assure you that we would be able to take any of these actions, or that these actions would permit us to meet our scheduled debt service obligations. In addition, in the event of our breach of the Term Loan Agreement with CRG, we may not be allowed to draw additional amounts under the agreement, we may be required to repay any outstanding amounts earlier than anticipated, and the lenders may foreclose on their security interest in our assets.

 

The CRG loan is collateralized by all our assets. Additionally, the terms of the Term Loan Agreement contain various affirmative and negative covenants agreed to by the Company. Among them, we must attain minimum annual revenue and minimum cash threshold levels. The minimum annual revenue threshold levels required by the Term Loan are $27.0 million, $31.0 million, $36.0 million, $45.0 million and $55.0 million for calendar years 2016, 2017, 2018, 2019 and 2020, respectively. The minimum cash balance required is $5.0 million, subject to certain conditions.

 

If we do not have annual revenue greater or equal to the annual revenue covenant in a calendar year, we will have the right to raisecure by raising subordinated debt or equity which we refer to as the CRG Equity Cure, equal to twice the difference between the annual revenue and the revenue covenant, with the total proceeds from this financing to be used to reduce the principal of the Term Loan Agreement. We cannot assure you that we will be able to achieve the annual revenue thresholds and the daily cash threshold. We cannot assure you that we would be able to raise the financing for the CRG Equity Cure,described above, if required. In addition, in the event of our breach of the Term Loan Agreement with CRG, we may not be allowed to draw additional amounts under the Term Loan Agreement, we may be required to repay any outstanding amounts earlier than anticipated, and the lenders may foreclose on their security interest in our assets.

 

Borrowings under the Term Loan Agreement are subject to certain conditions, including the non-occurrence of a material adverse change in our business or operations (financial or otherwise), or a material impairment of the prospect of repayment of obligations.

TearLab Corporation

Our existing Term Loan Agreement contains restrictive and financial covenants that may limit our operating flexibility.

 

Our existing Term Loan Agreement with CRG contains certain restrictive covenants that limit our ability to incur additional indebtedness and liens, merge with other companies or consummate certain changes of control, acquire other companies, engage in new lines of business, make certain investments, pay dividends, transfer or dispose of assets, amend certain material agreements or enter into various specified transactions. We therefore may not be able to engage in any of the foregoing transactions unless we obtain the consent of the lender or terminate the Term Loan Agreement. There is no guarantee that we will be able to generate sufficient cash flow or sales to meet the financial covenants or pay the principal and interest under the agreement. Furthermore, there is no guarantee that future working capital, borrowings or equity financing will be available to repay or refinance the amounts outstanding under the Term Loan Agreement.

 

TearLab Corporation

Our financial results may vary significantly from year-to-year [and quarter-to-quarter] due to a number of factors, which may lead to volatility in the trading price of our common stock.

 

Our annual and quarterly revenue and results of operations have varied in the past and may continue to vary significantly from year-to-year and quarter-to-quarter. The variability in our annual and quarterly results of operations may lead to volatility in our stock price as research analysts and investors respond to these annual fluctuations. These fluctuations are due to numerous factors that are difficult to forecast, including:

 

 fluctuations in demand for our products;
 
changes in customer budget cycles and capital spending;
 seasonal variations in customer operations that could occur during holiday or summer vacation periods;
 
tendencies among some customers to defer purchase decisions until the end of the quarter;
 
the unit value of our systems;
 changes in our pricing and sales policies or the pricing and sales policies of our competitors;
 
changes in reimbursement levels that might negatively impact our pricing policies;
 our ability to design, manufacture and deliver products to our customers in a timely and cost effective manner;
 
quality control or yield problems atin our manufacturing suppliers;
 our ability to timely obtain adequate quantities of the components used in our products;
 
new product introductions or enhancements by us and our competitors;
 
unanticipated increases in costs or expenses;
 our complex, variable and, at times, lengthy sales cycle;
 
global economic conditions; and
 fluctuations in foreign currency exchange rates.

 

In addition, we may experience seasonal variations in our customer operations such as could occur during holiday vacation periods. For example, one of our principal target markets consists of private ophthalmic and optometric practices, and our quarterly operating results in the quarter ending September 30 of each fiscal year could be adversely affected by summer or holiday vacation periods. The foregoing factors, as well as other factors, could materially and adversely affect our quarterly and annual results of operations. In addition, a significant amount of our operating expenses are relatively fixed due to our manufacturing, research and development, and sales and general administrative efforts. Any failure to adjust spending quickly enough to compensate for a revenue shortfall could magnify the adverse impact of such revenue shortfall on our results of operations. We expect that our sales will continue to fluctuate on a quarterly basis and our financial results for some periods may differ from those projected by securities analysts, which could significantly decrease the price of our common stock.

TearLab Corporation

Risks Related to Our Business

 

Our near-term success is highly dependent on the success of the TearLab® Osmolarity System, and we cannot be certain that it will be successfully commercialized in the United States.

 

The TearLab® Osmolarity System is currently our only product. Our product is currently sold outside of the United States pursuant to CE mark approval; in Canada pursuant to a Health Canada Medical Device License; and in the United States as a result of having received 510(k) approval from the FDA to market the TearLab® Osmolarity System to those reference and physician operated laboratories with CLIA waiver certifications. Even though the TearLab® Osmolarity System has received all regulatory approvals in the United States, it may never generate sufficient sales to achieve profitability.be successfully commercialized. If the TearLab® Osmolarity System is not as successfully commercialized as expected, we may not be able to generate sufficient revenue, to become profitable or continue our operations. Any failure of the TearLab® Osmolarity System to be successfully commercialized in the United States would have a material adverse effect on our business, operating results, financial condition and cash flows and could result in a substantial decline in the price of our common stock.

 

Our near-term success is highly dependent on increasing sales of the TearLab® Osmolarity System outside the United States, and we cannot be certain that we will successfully increase such sales.

 

Our product is currently sold outside of the United States pursuant to CE mark approval and Health Canada Approval in Canada. Our near-term success is highly dependent on increasing our international sales. We may also be required to register our product with health departments in our foreign market countries. A failure to successfully register in such markets would negatively affect our sales in any such markets. In addition, import taxes are levied on our product in certain foreign markets. Other countries may adopt taxation codes on imported products. Increases in such taxes or other restrictions on our product could negatively affect our ability to import, distribute and price our product.

 

We have outstanding liabilities, which could adversely affect our ability to adjust our business to respond to competitive pressures and to obtain sufficient funds to satisfy our future research and development needs, and to defend our intellectual property.

 

As of SeptemberJune 30, 2016,2017, our total liabilities were $31.2$33.7 million including $26.0$27.4 million of long-term obligations under our Term Loan Agreement. Our significant liability service requirements could adversely affect our ability to operate our business and may limit our ability to take advantage of potential business opportunities. For example:example, our liabilities present the following risks:

 

 our liabilities increase our vulnerability to economic downturns and adverse competitive and industry conditions and could place us at a competitive disadvantage compared to those of our competitors that are less leveraged;
   
 our liabilities could limit our flexibility in planning for, or reacting to, changes in our business and our industry and could limit our ability to pursue other business opportunities, borrow money for operations or capital in the future and implement our business strategies; and
   
 our liabilities may restrict us from raising additional funds on satisfactory terms to fund working capital, capital expenditures, product development efforts, strategic acquisitions, investments and alliances, and other general corporate requirements.

TearLab Corporation

  

If we are at any time unable to generate sufficient cash flow to service our liabilities when payment is due, we may be required to attempt to renegotiate the terms of the instruments relating to the liabilities, seek to refinance all or a portion of the liabilities or obtain additional financing. There can be no assurance that we will be able to successfully renegotiate such terms, that any such refinancing would be possible or that any additional financing could be obtained on terms that are favorable or acceptable to us.

 

32 

TearLab Corporation

We will face challenges in bringing the TearLab® Osmolarity System to market in the United States and may not succeed in executing our business plan.

 

There are numerous risks and uncertainties inherent in the development of new medical technologies. In addition to our requirement for additional capital, our ability to bringsuccessfully commercialize the TearLab® Osmolarity System to market in the United States and to execute our business plan successfully is subject to the following risks, among others:

 

 Our clinical trials may not succeed. Clinical testing is expensive and can take longer than originally anticipated. The outcomes of clinical trials are uncertain, and failure can occur at any stage of the testing. We could encounter unexpected problems, which could result in a delay in efforts to complete clinical trials supporting our commercialization efforts.
   
 The TearLab® Osmolarity System is rated under a CLIA waiver certification which requires our customers to be certified under the CLIA waiver requirements to be reimbursed under Medicare, including certain parallel state requirements. If our customers are unwilling or unable to comply with such requirements, it could have an adverse effect on their acceptance of and on our ability to market the TearLab® Osmolarity System in the United States.System.
   
 Our suppliers and we will be subject to numerous FDA requirements covering the design, testing, manufacturing, quality control, labeling, advertising, promotion and export of the TearLab® Osmolarity System and other matters. If our suppliers or we fail to comply with these regulatory requirements, the TearLab® Osmolarity System could be subject to restrictions or withdrawals from the market and we could become subject to penalties.withdrawals.
   
 Even though we successfully obtained the sought-after FDA approvals, we may be unable to commercialize the TearLab® Osmolarity System successfully in the United States. Successful commercialization will depend on a number of factors, including, among other things, achieving widespread acceptance of the TearLab® Osmolarity System among physicians, establishing adequate sales and marketing capabilities, addressing competition effectively, the ability to obtain and enforce patents to protect proprietary rights from use by would-be competitors, key personnel retention and ensuring sufficient manufacturing capacity and inventory to support commercialization plans.inventory.

 

Our business is subject to health care industry and government cost-containment measures that could result in reduced sales of our TearLab® Osmolarity System.

 

Most of our customers rely on third-party payers, including government programs and private health insurance plans, to reimburse some or all of the cost of the procedures which use our TearLab® Osmolarity System. The continuing efforts of governmental authorities, insurance companies, and other health care payers to contain or reduce these costs could lead to patients and providers being unable to obtain approval for payment from these third-party payers. If patients and providers cannot obtain third-party payer payment approval, the use of our TearLab® Osmolarity System may decline significantly and our customers may reduce or eliminate the use of our system. The cost-containment measures that health care providers are instituting, both in the U.S. and internationally, could harm our ability to operate profitably. For example, managed care organizations have successfully negotiated volume discounts for pharmaceuticals. While this type of discount pricing does not currently exist for the medical systems we supply, if managed care or other organizations were able to affect discount pricing for such systems, it could result in lower prices to our customers from their customers and, in turn, reduce the amounts we can charge our customers for our products.

TearLab Corporation

 

In addition to general health care industry cost-containment, the Centers for Medicare and Medicaid Services (CMS) released its final rule implementing section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) that will require reporting entities to report private payorpayer rates paid to laboratories for lab tests, which will be used to calculate Medicare payment rates. This final rule also announces CMS’ decision to move the implementation date for the private payorpayer rate-based fee schedule to January 1, 2018. Reporting entities, which would primarily be ourcertain qualifying customers in the U.S., that derive a certain percentage and volume of their revenue from laboratory tests from Medicare, will report private payorpayer rates for our laboratory tests which will serve under the act as a baseline for future reimbursement. Although it is very early to understand if reimbursement for our product or future products will be impacted, the act does provide a maximum reimbursement reduction of 10% per year for the yearyears 2018 through 2020. For years 2021 through 2023, the maximum reduction on the reimbursement rate is 15%. Should reimbursement for our products be reduced as a result of PAMA, this could negatively impact our pricing and commercialization of our products in the U.S.

 

TearLab Corporation

If we are subject to regulatory enforcement action as a result of our failure to comply with regulatory requirements, our commercial operations would be harmed.

 

While we received the 510(k) clearance and CLIA waiver that we were seeking, we arewill be subject to significant ongoing regulatory requirements, and if we fail to comply with these requirements, we could be subject to enforcement action by the FDA or state agencies, including:

 

 adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties;
   
 repair, replacement, refunds, recall or seizure of our product;
   
 operating restrictions or partial suspension or total shutdown of production
   
 delay or refusal of our requests for 510(k) clearance or premarket approval of new products or of new intended uses or modifications to our existing product;
   
 refusal to grant export approval for our products;
   
 withdrawing 510(k) clearances or premarket approvals that have already been granted; and
   
 criminal prosecution.prosecution

. 

If the government initiated any of these enforcement actions, our business could be harmed.

 

We are required to demonstrate and maintain compliance with the FDA’s Quality System Regulation, or the QSR. The QSR is a complex regulatory scheme that covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of our products. The FDA must determine that the facilities which manufacture and assemble our products that are intended for sale in the United States, as well as the manufacturing controls and specifications for these products, are compliant with applicable regulatory requirements, including the QSR. The FDA enforces the QSR through periodic unannounced inspections. The FDA has not yet inspected our facilities, and we cannot assure you that we will pass any future FDA inspection. Our failure, or the failure of our suppliers, to take satisfactory corrective action in response to an adverse QSR inspection could result in enforcement actions, including a public warning letter, a shutdown of our manufacturing operations, a recall of our product, civil or criminal penalties or other sanctions, which would significantly harm our available inventory and sales and cause our business to suffer.

TearLab Corporation

If we are unable to fully comply with federal and state “fraud and abuse laws,” we could face substantial penalties, which may adversely affect our business, financial condition and results of operations.

 

We are subject to various laws pertaining to health care fraud and abuse, including the U.S. Anti- Kickback Statute, physician self-referral laws (the “Stark Law”), the U.S. False Claims Act, the U.S. False Statements Statute, the Physician Payment Sunshine Act, and state law equivalents to these U.S. federal laws, which may not be limited to government-reimbursed items and may not contain identical exceptions. Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, civil and criminal penalties, damages, fines, exclusion from participation in U.S. federal and state health care programs, including Medicare and Medicaid, and the curtailment or restructuring of operations. Any action against us for violation of these laws could have a significant impact on our business. In addition, we are subject to the U.S. Foreign Corrupt Practices Act. Any action against us for violation by us or our agents or distributors of this act could have a significant impact on our business.

TearLab Corporation

 

If we fail to comply with contractual obligations and applicable laws and regulations governing the handling of patient identifiable medical information, we could suffer material losses or be adversely affected by exposure to material penalties and liabilities.

 

Many, if not all of our customers, are covered entities under the Health Insurance Portability and Accountability Act of August 1996 or HIPAA. As part of the operation of our business, we provide reimbursement assistance to certain of our customers and as a result we act in the capacity of a business associate with respect to any patient-identifiable medical information, or PHI, we receive in connection with these services. We and our customers must comply with a variety of requirements related to the handling of patient information, including laws and regulations protecting the privacy, confidentiality and security of PHI. The provisions of HIPAA require our customers to have business associate agreements with us under which we are required to appropriately safeguard the PHI we create or receive on their behalf. Further, we and our customers are required to comply with HIPAA security regulations that require us and them to implement certain administrative, physical and technical safeguards to ensure the confidentiality, integrity and availability of electronic PHI, or EPHI. We are required by regulation and contract to protect the security of EPHI that we create, receive, maintain or transmit for our customers consistent with these regulations. To comply with our regulatory and contractual obligations, we may have to reorganize processes and invest in new technologies. We also are required to train personnel regarding HIPAA requirements. If we, or any of our employees or consultants, are unable to maintain the privacy, confidentiality and security of the PHI that is entrusted to us, we and/or our customers could be subject to civil and criminal fines and sanctions and we could be found to have breached our contracts with our customers. Under the Health Information Technology for Economic and Clinical Health Act, or HITECH Act, and recent omnibus revisions to the HIPAA regulations, we are directly subject to HIPAA’s criminal and civil penalties for breaches of our privacy and security obligations and are required to comply with security breach notification requirements. The direct applicability of the HIPAA privacy and security provisions and compliance with the notification requirements requires us to incur additional costs and may restrict our business operations.

 

Our patents may not be valid, and we may not obtain and enforce patents to protect our proprietary rights from use by would-be competitors. Companies with other patents could require us to stop using or pay to use required technology.

 

Our owned and licensed patents may not be valid, and we may not obtain and enforce patents to maintain trade secret protection for our technology. The extent to which we are unable to do so could materially harm our business.

TearLab Corporation

 

We have applied for, and intend to continue to apply for, patents relating to the TearLab® Osmolarity System, products in development and related technology and processes. Such applications may not result in the issuance of any patents, and any patents now held or that may be issued may not provide adequate protection from competition. Furthermore, it is possible that patents issued or licensed to us may be challenged successfully. In that event, if we have a preferred competitive position because of any such patents, any preferred position would be lost. If we are unable to secure or to continue to maintain a preferred position, the TearLab® Osmolarity System could become subject to competition from the sale of similar competinggeneric products.

TearLab Corporation

 

Patents issued or licensed to us may be infringed by the products or processes of others. The cost of enforcing patent rights against infringers, if such enforcement is required, could be significant and the time demands could interfere with our normal operations. There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical, biotechnology and medical technology industries. We are currently involved in litigation defending our patent rights in Canada. Efforts to defend our rights could incur significant costs and may or may not be resolved in our favor. We could become a party to additional patent litigation and other proceedings. The cost to us of any patent litigation, even if resolved in our favor, could be substantial. Some of our would-be competitors may sustain the costs of such litigation more effectively than we can because of their greater financial resources. Litigation also may absorb significant management time.

 

Unpatented trade secrets, improvements, confidential know-how and continuing technological innovation are important to our future scientific and commercial success. Although we attempt, and will continue to attempt, to protect our proprietary information through reliance on trade secret laws and the use of confidentiality agreements with corporate partners, collaborators, employees and consultants and other appropriate means, these measures may not effectively prevent disclosure of our proprietary information, and, in any event, others may develop independently, or obtain access to, the same or similar information.

 

Certain of our patent rights are licensed to us by third parties. If we fail to comply with the terms of these license agreements, our rights to those patents may be terminated, and we will be unable to conduct our business.

 

It is possible that a court may find us to be infringing upon validly issued patents of third parties. In that event, in addition to the cost of defending the underlying suit for infringement, we may have to pay license fees and/or damages and may be enjoined from conducting certain activities. Obtaining licenses under third-party patents can be costly, and such licenses may not be available at all.

 

We may face future product liability claims.

 

The testing, manufacturing, marketing and sale of therapeutic and diagnostic products entail significant inherent risks of allegations of product liability. Our past use of the RHEO System and the components of the SOLX Glaucoma System in clinical trials and the commercial sale of those products may have exposed us to potential liability claims. Our use of the TearLab® Osmolarity System and its commercial sale could also expose us to liability claims. All of such claims might be made directly by patients, health care providers or others selling the products. We carry clinical trials and product liability insurance to cover certain claims that could arise, or that could have arisen, during our clinical trials or during the commercial use of our products. We currently maintain clinical trials and product liability insurance with aggregate annual coverage limits of $2.0 million. Such coverage, and any coverage obtained in the future, may be inadequate to protect us in the event of successful product liability claims, and we may not increase the amount of such insurance coverage or even renew it. A successful product liability claim could materially harm our business. In addition, substantial, complex or extended litigation could result in the incurrence of large expenditures and the diversion of significant resources.

TearLab Corporation

If we do not introduce new commercially successful products in a timely manner, our products may become obsolete over time, customers may not buy our products and our revenue and profitability may decline.

 

Demand for our products may change in ways we may not anticipate because of:

 

 evolving customer needs;
   
 the introduction of new products and technologies; and
   
 evolving industry standards.

TearLab Corporation

 

Without the timely introduction of new commercially successful products and enhancements, our products may become obsolete over time, in which case our sales and operating results would suffer. The success of our new product offerings will depend on several factors, including our ability to:

 

 properly identify and anticipate customer needs;
   
 commercialize new products in a cost-effective and timely manner;
   
 manufacture and deliver products in sufficient volumes on time;
   
 obtain and maintain regulatory approval for such new products;
   
 differentiate our offerings from competitors’ offerings;
   
 achieve positive clinical outcomes; and
   
 provide adequate medical and/or consumer education relating to new products.

 

Moreover, innovations generally will require a substantial investment in research and development before we can determine the commercial viability of these innovations and we may not have the financial resources necessary to fund these innovations. In addition, even if we successfully develop enhancements or new generations of our products, these enhancements or new generations of products may not produce revenue in excess of the costs of development and they may be quickly rendered obsolete by changing customer preferences or the introduction by our competitors of products embodying new technologies or features.

 

We rely on a limited number of suppliers of each of the key components of the TearLab® Osmolarity System and are vulnerable to fluctuations in the availability and price of our suppliersproducts and services.

 

We purchase each of the key components of the TearLab® Osmolarity System from a limited number of third-party suppliers. Our suppliers may not provide the components or other products needed by us in the quantities requested, in a timely manner or at a price we are willing to pay. In the event we were unable to renew our agreements with our suppliers or they were to become unable or unwilling to continue to provide important components in the required volumes and quality levels or in a timely manner, or if regulations affecting the components were to change, we would be required to identify and obtain acceptable replacement supply sources. We may not be able to obtain alternative suppliers or vendors on a timely basis, or at all, which could disrupt or delay, or halt altogether, our ability to manufacture or deliver the TearLab® Osmolarity System. If any of these events should occur, our business, financial condition, cash flows and results of operations could be materially adversely affected.

 

We face intense competition, and our failure to compete effectively could have a material adverse effect on our results of operations.

 

We face intense competition in the markets for ophthalmic products and these markets are subject to rapid and significant technological change. WeAlthough we have no direct competitors, we have numerous potential competitors in the United States and abroad, including one direct competitor recently launched in Canada.abroad. We face potential competition from industry participants marketing conventional technologies for the measurement of osmolarity and other in-lab testing technologies, and commercially available methods, such as the Schirmer Test and ocular surface staining. Many of our potential competitors have substantially more resources and a greater marketing scale than we do. If we are unable to develop and produce or market our products to effectively compete against our competitors, our operating results will materially suffer.

TearLab Corporation

If we lose key personnel, or we do not attract and retain highly qualified personnel on a cost-effective basis, it would be more difficult for us to manage our existing business operations and to identify and pursue new growth opportunities.

 

Our success depends, in large part, upon our ability to attract and retain highly qualified scientific, clinical, manufacturing and management personnel. In addition, any difficulties in retaining key personnel or managing this growth could disrupt our operations. Future growth will require us to continue to implement and improve our managerial, operational and financial systems, and to continue to recruit, train and retain, additional qualified personnel, which may impose a strain on our administrative and operational infrastructure. The competition for qualified personnel in the medical technology field is intense. We are highly dependent on our continued ability to attract, motivate and retain highly qualified management, clinical and scientific personnel.

 

Due to our limited resources, we may not effectively recruit, train and retain additional qualified personnel. If we do not retain key personnel or manage our growth effectively, we may not implement our business plan effectively.

 

Furthermore, we have not entered into non-competition agreements with all of our key employees. In addition, we do not maintain “key person” life insurance on any of our officers, employees or consultants. The loss of the services of existing personnel, the failure to recruit additional key scientific, technical and managerial personnel in a timely manner, and the loss of our employees to our competitors would harm our research and development programs and our business.

 

If we fail to establish and maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired, which would adversely affect our consolidated operating results, our ability to operate our business and our stock price.

 

Ensuring that we have adequate internal financial and accounting controls and procedures in place to produce accurate financial statements on a timely basis is a costly and time-consuming effort that needs to be re-evaluated frequently. Failure on our part to maintain effective internal financial and accounting controls would cause our financial reporting to be unreliable, could have a material adverse effect on our business, operating results, financial condition and cash flows, and could cause the trading price of our common stock to fall dramatically.

 

Maintaining proper and effective internal controls will require substantial management time and attention and may result in our incurring substantial incremental expenses, including with respect to increasing the breadth and depth of our finance organization to ensure that we have personnel with the appropriate qualifications and training in certain key accounting roles and adherence to certain control disciplines within the accounting and reporting function. Any failure in internal controls or any errors or delays in our financial reporting would have a material adverse effect on our business and results of operations and could have a substantial adverse impact on the trading price of our common stock.

TearLab Corporation

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP. Our management does not expect that our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Our management has identified control deficiencies in the past and may identify additional deficiencies in the future.

TearLab Corporation

 

We cannot be certain that the actions we are taking to improve our internal controls over financial reporting will be sufficient or that any changes in processes and procedures can be completed in a timely manner. In future periods, if the process required by Section 404 of the Sarbanes-Oxley Act of 2002 reveals material weaknesses or significant deficiencies, the correction of any such material weaknesses or significant deficiencies could require additional remedial measures which could be costly and time-consuming. In addition, we may be unable to produce accurate financial statements on a timely basis. Any of the foregoing could cause investors to lose confidence in the reliability of our condensed consolidated financial statements, which could cause the market price of our common stock to decline and make it more difficult for us to finance our operations and growth.

 

Risks Related to Our Common Stock

 

Our common stock may be delisted from The NASDAQNasdaq Capital Market if we cannot maintain compliance with NASDAQ’s continued listing requirements.

 

In order to maintain our listing on NASDAQ, we are required to comply with the NASDAQ requirements,Listing Requirements, which include, but are not limited to, maintaining a minimum stockholders’ equity or market capitalization and minimum bid price requirement.price. In particular, we are required to (i) maintain a minimum (i) bid price of $1.00 and we have traded below that threshold since February 2, 2016, and (ii) maintain a minimum stockholders’ equity of $2.5 million or meet alternative market capitalization or income from continuing operations tests.of $35 million. On March 16, 2016, we received a notice from NASDAQ stating that we were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”) because our common stock failed to maintain a minimum closing bid price of $1.00 for the prior 30 consecutive business days. The Noticenotice had no immediate effect on the NASDAQCompany’s listing or trading of the Company’s common stock.stock on NASDAQ.

 

On September 16, 2016, we received a letter from the NASDAQ Listing Qualifications Staff (the “Staff”). The, which indicated the Staff had determined to delist our securities from the NASDAQThe Nasdaq Capital Market due to our continued non-compliance with the Minimum Bid Price Rule within 180 calendar days. The Company has appealed that letter, which has stayed any de-listing actions, and has a hearing with the NASDAQ Hearings Panel (the “Panel”) scheduled for early November 2016, at which we will present our plan to demonstrateRule. To regain compliance with the Minimum Bid Price Rule, we filed a certificate of amendment to our amended and request an extensionrestated certificate of timeincorporation to effect (i) a reverse stock split of all of the outstanding shares of our common stock and those shares held by us in treasury stock, if any, at a ratio of one-for ten shares, and (ii) a reduction in the total number of authorized shares of our common stock from 95,000,000 to 9,500,000. As of May 8, 2017, the last reported sale price of our common stock was $1.95 per share.

Additionally, on November 8, 2016, we received notice from the Staff indicating that the Company did not satisfy Nasdaq Listing Rule 5550(b), insofar as the Company’s market value of listed securities (“MVLS”) had closed below $35 million for the previous 30 consecutive business days, and we did not satisfy either of the alternative criteria under Nasdaq Listing Rule 5550(b) which requires stockholders’ equity of at least $2.5 million or net income from continuing operations of at least $500,000 in the most recently completed fiscal year or in two of the three most recently completed fiscal years. The notice had no immediate effect on the NASDAQ listing or trading of the Company’s common stock.

In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company was granted a 180-calendar day grace period within which to comply.regain compliance with the MVLS requirement, through May 8, 2017. To evidence compliance with the MVLS requirement, the Company’s MVLS must close at $35 million or more for a minimum of 10 consecutive business days during the 180-calendar day compliance period ended May 8, 2017.

On May 10, 2017, we received notice from the Staff that the Staff had determined to delist our securities from The Nasdaq Capital Market due to our continued non-compliance with the MVLS requirement, unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”). On June 19, 2017, the Nasdaq Hearings Panel (the “Panel”) granted the Company’s request for continued listing on The Nasdaq Capital Market, pursuant to an extension and the Company’s continued progress on the compliance plan presented to the Panel, through October 6, 2017, by which date the Company must evidence full compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $2.5 million stockholders’ equity requirement.

TearLab Corporation

 

If the Panel declines to grant us an extension of time or we fail to regain compliance with one of the applicable requirements, our stock may be delisted. Delisting from the NASDAQThe Nasdaq Capital Market could make trading in our common stock more difficult for investors, potentially leading to declines in our share price and liquidity. Without a NASDAQThe Nasdaq Capital Market listing, stockholders may have a difficult time getting a quote for the sale or purchase of our stock, the sale or purchase of our stock would likely be made more difficult and the trading volume and liquidity of our stock could decline. Delisting from the NASDAQThe Nasdaq Capital Market could also result in negative publicity and could also make it more difficult for us to raise additional capital. The absence of such a listing may adversely affectimpact the acceptance of our common stock as currency or the value accorded by other parties. Further, if we are delisted, we would also incur additional costs under state blue sky laws in connection with any sales of our securities. These requirements could severely limit the market liquidity of our common stock and the ability of our stockholders to sell our common stock in the secondary market.

If our common stock is delisted by NASDAQ, our common stock may be eligible to trade on an over-the-counter quotation system, such as the OTCQB market, where an investor may find it more difficult to sell our stock or obtain accurate quotations as to the market value of our common stock. We cannot assure you that our common stock, if delisted from the NASDAQThe Nasdaq Capital Market, will be listed on another national securities exchange or quoted on an over-the counter quotation system.

TearLab Corporation

 

If our common stock is delisted, it would comefall within the definition of a “penny stock” as defined in the Securities Exchange Act of 1934, or the Exchange Act, and would be covered by Rule 15g-9 of the Exchange Act. That Rule imposes additional sales practice requirements on broker-dealers who sell securities to persons other than established customers and accredited investors. For transactions covered by Rule 15g-9, the broker-dealer must make a special suitability determination for the purchaser and receive the purchaser’s written agreement to the transaction prior to the sale. Consequently, Rule 15g-9, if it were to become applicable, would affect the ability or willingness of broker-dealers to sell our securities, and accordingly would affect the ability of stockholders to sell their securities in the public market. These additional procedures could also limit our ability to raise additional capital in the future.

The trading price of our common stock may be volatile.

 

The market prices for, and the trading volumes of, securities of medical device companies, such as ours, have been historically volatile. The market has experienced, from time to time, significant price and volume fluctuations unrelated to the operating performance of particular companies. The market price of our common shares may fluctuate significantly due to a variety of factors, including:

 

our results of operations;
 the results of pre-clinical testing and clinical trials by us, our collaborators and/or our competitors;
   
 technological innovations or new diagnostic products;
   
 governmental regulations and reimbursement levels;
   
 developments in patent or other proprietary rights;
   
 litigation;
   
 public concern regarding the safety of products developed by us or others;
   
 comments by securities analysts;
   
 the issuance of additional shares to obtain financing or for acquisitions;
   
 general market conditions in our industry or in the economy as a whole; and
   
 political instability, natural disasters, war and/or events of terrorism; and
   
 failure to maintain our NASDAQ listing.

TearLab Corporation

 

In addition, the stock market in general has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of individual companies. Broad market and industry factors may seriously affect the market price of our stock, regardless of actual operating performance. In the past, securities class action litigation often follows periods of volatility in the overall market and market price of a particular company’s securities. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’s attention and resources.

 

Because we do not expect to pay dividends on our common stock, stockholders will benefit from an investment in our common stock only if it appreciates in value.

We have never paid cash dividends on our common stock and have no present intention to pay any dividends in the future. We are not profitable and may not earn sufficient revenue to meet all operating cash needs. As a result, we intend to use all available cash and liquid assets in the development of our business. Any future determination about the payment of dividends will be made at the discretion of our board of directors and will depend upon our earnings, if any, our capital requirements, our operating and financial conditions and on such other factors as our board of directors may deem relevant. As a result, the success of an investment in our common stock will depend upon any future appreciation in its value. There is no guarantee that our common stock will appreciate in value or even maintain the price at which stockholders have purchased their shares.

TearLab Corporation

Warrant holders will not be entitled to any of the rights of common stockholders, but will be subject to all changes made with respect thereto.

 

If you hold warrants, you will not be entitled to any rights with respect to our common stock (including, without limitation, voting rights and rights to receive any dividends or other distributions on our common stock), but you will be subject to all changes affecting our common stock. You will have rights with respect to our common stock only if you receive our common stock upon exercise of the warrants and only as of the date when you become a record owner of the shares of our common stock upon such exercise. For example, if a proposed amendment to our charter or bylaws requires stockholder approval and the record date for determining the stockholders of record entitled to vote on the amendment occurs prior to the date that you are deemed to be the owner of the shares of our common stock due upon exercise of your warrants, you will not be entitled to vote on the amendment; although, you will nevertheless be subject to any changes in the powers, preferences or special rights of our common stock.

 

We can issue shares of preferred stock that may adversely affect the rights of holders of our common stock.

 

Our certificate of incorporation authorizes us to issue up to 10.0 million shares of preferred stock with designations, rights, and preferences determined from time to time by our board of directors. Accordingly, our board of directors is empowered, without stockholder approval, to issue preferred stock with dividend, liquidation, conversion, voting or other rights superior to those of holders of our common stock. For example, an issuance of shares of preferred stock could:

 

 adversely affect the voting power of the holders of our common stock;
   
 make it more difficult for a third party to gain control of us;
   
 discourage bids for our common stock at a premium;
   
 limit or eliminate any payments that the holders of our common stock could expect to receive upon our liquidation; or
   
 otherwise adversely affect the market price or our common stock.

TearLab Corporation

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

 

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

ITEM 3.DEFAULTS UPON SENIOR SECURITIES.

 

Not applicable.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

ITEM 5.OTHER INFORMATION.

 

ITEM 5. OTHER INFORMATION.On June 15, 2017, the Company entered into amended employment agreements with Joseph Jensen, the Company’s Chief Executive Officer, and Wes Brazell, the Company’s Chief Financial Officer (the “Amended Employment Agreements”). The Amended Employment Agreements reduce their severance payments from 2 years of base and bonus to 1 year, and from 18 months of benefits payments to 12 months. The Amended Employment Agreements also increase the time period in which they can leave the Company for good reason from 6 months to 12 months following a change in control.

 

None.

TearLab Corporation

ITEM 6.EXHIBITS

 

ITEM 6. EXHIBITS

Exhibit

Number

 

Exhibit Description

 

Incorporated by Reference

   
10.1#Amendment dated as of June 15, 2017 to Employment Agreement, by and between the registrant and Joseph Jensen
10.2#Amendment dated as of June 15, 2017 to Employment Agreement, by and between the registrant and Wes Brazell
10.3Termination of Cooperative Marketing Agreement between PRN Physicians Recommended Nutriceuticals, LLC and TearLab Research, Inc.  
31.1 CEO’s Certification required by Rule 13A-14(a) of the Securities Exchange Act of 1934.  
31.2 CFO’s Certification required by Rule 13A-14(a) of the Securities Exchange Act of 1934.
  
32.1+ CEO’s Certification of periodic financial reports pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, U.S.C. Section 1350.  
32.2+ CFO’s Certification of periodic financial reports pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, U.S.C. Section 1350.  
101.INS* XBRL Instance
  
101.SCH* XBRL Taxonomy Schema
  
101.CAL* XBRL Taxonomy Extension Calculation  
101.DEF* XBRL Taxonomy Extension Definition
  
101.LAB* XBRL Taxonomy Extension Labels  
101.PRE* XBRL Taxonomy Extension Presentation  

TearLab Corporation

#Management compensatory plan, contract or agreement

 

*XBRL information is furnished and not filed or a part of a registration statement or prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of section.

 

+In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release No. 33-8238 and 34-47986, Final Rule: Management’s Reports on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, the certifications furnished pursuant to this item will not be deemed “filed” for purposes of Section 18 of the Exchange Act (15 U.S.C. 78r), or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference

 

TearLab Corporation

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 TearLab Corp.
 (Registrant)
  
Date:November 9, 2016August 14, 2017/s/Joseph Jensen
 Joseph Jensen
 Chief Executive Officer

 

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