0001493152-18-006659.txt : 20180511 0001493152-18-006659.hdr.sgml : 20180511 20180511161137 ACCESSION NUMBER: 0001493152-18-006659 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 68 CONFORMED PERIOD OF REPORT: 20180331 FILED AS OF DATE: 20180511 DATE AS OF CHANGE: 20180511 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TearLab Corp CENTRAL INDEX KEY: 0001299139 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 593434771 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-51030 FILM NUMBER: 18826995 BUSINESS ADDRESS: STREET 1: 9980 HUENNEKENS ST. STREET 2: SUITE 100 CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 858-794-1400 MAIL ADDRESS: STREET 1: 9980 HUENNEKENS ST. STREET 2: SUITE 100 CITY: SAN DIEGO STATE: CA ZIP: 92121 FORMER COMPANY: FORMER CONFORMED NAME: OccuLogix, Inc. DATE OF NAME CHANGE: 20040730 10-Q 1 form10q.htm

 

 

 

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 THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended: March 31, 2018

 

[  ] 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 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, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

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

 

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

 

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

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 10,438,998 as of May 7, 2018.

 

 

 

 

 

 

    Page
     
PART I. FINANCIAL INFORMATION
     
Item 1. Financial Statements (Unaudited) 4
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 19
Item 3. Quantitative and Qualitative Disclosures about Market Risk 26
Item 4. Controls and Procedures 26
   
PART II. OTHER INFORMATION  
     
Item 1. Legal Proceedings 27
Item 1A. Risk Factors 28
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 40
Item 3. Defaults Upon Senior Securities 40
Item 4. Mine Safety Disclosures 40
Item 5. Other Information 40
Item 6. Exhibits 40

 

2

 

 

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 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 while our common stock is traded on the OTCQB market;
The planned continued commercialization of our current product;
Our ability to expand into next generation products, including our expectations regarding the TearLab DiscoveryTM Platform and the 510(k) application process;
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, including the impact of our new business model adopted in December 2017;
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 for our product and support our pricing strategies;
Our ability to execute our marketing strategy to ensure visibility and evidence-based positioning of the TearLab® Osmolarity System among eye care professionals given our reduced commercial resources;
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;
Our efforts to assist our customers in obtaining their CLIA waiver or providing them with support from certified professionals; and
The impact of our delisting from the NASDAQ Capital Market and our common stock being traded on the OTCQB.

 

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.

 

3

 

 

TearLab Corporation

 

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

 

CONDENSED CONSOLIDATED BALANCE SHEETS

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

(Unaudited)

 

   March 31, 2018   December 31, 2017 
         
ASSETS          
Current assets          
Cash  $7,431   $7,272 
Accounts receivable, net   1,452    1,536 
Inventory   1,683    1,998 
Prepaid expenses and other current assets   629    690 
Total current assets   11,195    11,496 
             
Fixed assets, net   2,460    2,739 
Intangible assets, net   7    10 
Other non-current assets   50    100 
Total assets  $13,712   $14,345 
             
LIABILITIES AND STOCKHOLDERS’ DEFICIT          
Current liabilities          
Accounts payable  $1,073   $1,720 
Accrued liabilities   2,649    2,859 
Deferred rent   34    42 
Current portion of long-term debt   3,630    - 
Total current liabilities   7,386    4,621 
             
Long-term debt, net of current portion   25,770    28,290 
             
Total liabilities   33,156    32,911 
             
Commitments and contingencies (Note 8)          
             
Stockholders’ deficit          
Capital stock          
Preferred Stock, $0.001 par value, 10,000,000 authorized, 934 and 2,012 issued and outstanding at March 31, 2018 and December 31, 2017, respectively   -    - 
Common stock, $0.001 par value, 40,000,000 authorized, 10,438,998 and 7,986,998 issued and outstanding at March 31, 2018 and December 31, 2017, respectively   10    8 
Additional paid-in capital   510,238    510,235 
Accumulated deficit   (529,692)   (528,809)
Total stockholders’ deficit   (19,444)   (18,566)
Total liabilities and stockholders’ deficit  $13,712   $14,345 

 

See accompanying notes to interim condensed consolidated financial statements

 

4

 

 

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 
   March 31, 
   2018   2017 
         
Revenue          
Product sales  $5,775   $5,987 
Reader equipment rentals   671    714 
Total revenue   6,446    6,701 
Cost of goods sold          
Cost of goods sold (excluding amortization of intangible assets)   1,836    2,542 
Cost of goods sold - reader equipment depreciation   288    466 
Gross profit   4,322    3,693 
Operating expenses          
Sales and marketing   1,020    3,332 
Clinical, regulatory and research & development   1,041    1,564 
General and administrative   2,044    2,187 
Total operating expenses   4,105    7,083 
Income (loss) from operations   217    (3,390)
Other income (expense)          
Interest income (expense)   (1,105)   (1,028)
Other, net   5    (3)
Total other income (expense)   (1,100)   (1,031)
Net loss and comprehensive loss  $(883)  $(4,421)
Weighted average shares outstanding - basic and fully diluted   9,562,122    5,367,311 
Net loss per share  $(0.09)  $(0.82)

 

See accompanying notes to interim condensed consolidated financial statements

 

5

 

 

TearLab Corporation

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(expressed in thousands of U.S. dollars)

(Unaudited)

 

   Three months ended 
   March 31, 
   2018   2017 
         
OPERATING ACTIVITIES          
Net loss for the period  $(883)  $(4,421)
Adjustments to reconcile net loss to cash used in operating activities:          
Stock-based compensation   8    289 
Depreciation of fixed assets   353    521 
Amortization of intangible assets   3    15 
Deferred interest on long-term debt   914    302 
Amortization of debt discount   193    154 
Changes in operating assets and liabilities:          
Accounts receivable, net   84    13 
Inventory   314    (131)
Prepaid expenses and other assets   111    10 
Accounts payable   (647)   889 
Accrued liabilities   (210)   123 
Deferred rent/revenue   (8)   (12)
Cash provided by (used in) operating activities   232    (2,248)
           
INVESTING ACTIVITIES          
Additions to fixed assets   (73)   (223)
Cash used in investing activities   (73)   (223)
           
FINANCING ACTIVITIES          
Repurchase of fractional shares upon reverse stock split   -    (3)
Proceeds from the issuance of employee stock purchase plan shares   -    35 
Cash provided by financing activities   -    32 
           
Increase (decrease) in cash and cash equivalents during the period   159    (2,439)
Cash, beginning of period   7,272    15,471 
Cash, end of period  $7,431   $13,032 
           
Supplemental cash flow information          
Cash paid for interest  $-   $571 

 

See accompanying notes to interim condensed consolidated financial statements

 

6

 

 

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 (“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 statements include the accounts of the Company and all of its wholly owned subsidiaries. Intercompany accounts and transactions have been eliminated on consolidation.

 

Liquidity and Going Concern

 

The accompanying condensed 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. The Company has sustained substantial losses of $883 and $4,421 for the three months ended March 31, 2018 and 2017, respectively. Based on the Company’s expected rate of cash consumption in the latter quarters of 2018, the Company estimates it will need additional capital in the first quarter of 2019 and its prospects for obtaining that capital are uncertain. The Company may be able to raise 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 2019 without violating an existing covenant on the Term Loan Agreement (see Note 5). 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.

 

2. SIGNIFICANT ACCOUNTING POLICIES

 

The Condensed Consolidated Balance Sheet at December 31, 2017 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 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, 2017. The audited financial statements for the year ended December 31, 2017, filed with the SEC with the Company’s annual report on Form 10-K on March 5, 2018 include a summary of 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 normal recurring items, have been included in the unaudited condensed consolidated financial statements for the interim periods presented.

 

7

 

 

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

 

On January 1, 2018 the Company adopted Topic 606 – Revenue from Contracts with Customers using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under Topic 605 – Revenue Recognition.

 

There was no net reduction to opening retained earnings as a result of adopting Topic 606 and no impact to revenues for the three months ended March 31, 2018.

 

Revenue is recognized when obligations under the terms of a contract with our customer are satisfied; generally this occurs with the transfer of control of our products or services. Revenue is measured as the amount of consideration we expect to receive in exchange for transferring goods or providing services which includes estimates of variable consideration that results from returns, rebates or test card replacements. The Company records allowances for returns or rebates and reports revenue net of such amounts, which was immaterial for the three months ended March 31, 2018. Sales and other taxes we collect concurrent with revenue-producing activities are excluded from revenue. The Company’s payment terms are typically upon shipment or net 30.

 

The Company sells its proprietary TearLab® Osmolality System and related test cards to external customers, who are primarily eye care professionals, for use in osmolality 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 (referred to as either “Use Agreements”, “Masters Agreements” or “Flex Agreements”), or from agreements to sell the reader equipment and disposable test cards at their stand-alone selling price with no contractual future purchase commitment (referred to as “Purchase Agreements”).

 

Use, Masters, and Flex 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. Two performance obligations exist under these contracts, related to the customers’ right to use the reader equipment and orders of test cards. As the customer has the ability and right to operate the reader equipment in a manner it determines as well as obtain the output from using the reader equipment, the revenue related to the reader equipment use performance obligation is recognized in accordance with ASC 840 – Leases, wherein revenue related to the reader equipment is recognized over the defined contract term. Revenue related to disposable test cards is recognized as the disposable test cards are shipped. Based on the nature of these contracts, which provide terms for the future purchase of test cards but do not contractually obligate the customer to do so, each purchase of test cards is treated as its own distinct contract with a performance obligation to provide the test cards ordered, memorialized by the customers’ purchase order/request. 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 standalone selling price, which is estimated using the selling prices of the reader device and test cards under Purchase Agreements, discussed further below.

 

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 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 Consolidated Statements of Operations and Comprehensive Loss.

 

Purchase Agreements

 

Revenue recognition for Purchase Agreements is based on the individual performance obligations determined to exist in the contract. Since the reader equipment and the test cards are separate and distinct delivered items, the delivery of each are considered separate performance obligations. The reader equipment and test cards are separately identified under the Purchase Agreements and are sold at their standalone selling price. The Company recognizes revenue for each of the performance obligations only when it determines that all applicable recognition criteria have been met, which is usually upon shipment to the customer. Under Purchase Agreements, the customer is not contractually obligated to purchase additional test cards, and each subsequent order of test cards represents a separate and distinct contract with the performance obligation to provide the test cards ordered.

 

Amounts billed to customers for shipping and handling of a sales transaction are included as revenue. For the three months ended March 31, 2018 and 2017, the Company recognized revenue from shipping and handling of $39 and $44, respectively.

 

8

 

 

The following table presents our revenues disaggregated by revenue source. Sales and usage-based taxes are excluded from revenues:

 

   Three months ended March 31, 
   2018   2017 
         
Product Sales  $5,775   $5,987 
Reader Equipment Rentals   671    714 
   $6,446   $6,701 

 

Arrangements with Multiple Performance Obligations

 

Our contracts with customers may include multiple performance obligations. For such arrangements, we allocate revenue to each performance obligation based on its relative standalone selling price. We generally determine standalone selling prices based on the separate prices charged to customers for the reader device and test cards under Purchase Agreements.

 

Return Reserve

 

Although the Company has a no return policy for its products, the Company has established a return reserve for product sales that contain an implicit right of return. The Company reserves for estimated returns or refunds by reducing revenue at the time of shipment based on historical experience. The reserve of $7 and $9 as of March 31, 2018 and December 31, 2017, respectively, has been recorded as a reduction of revenue and is included in accounts receivable.

 

Practical Expedients and Exemptions

 

We generally expense outside sales commissions when incurred because the amortization period would have been one year or less. These costs are recorded within sales and marketing expenses.

 

We do not disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one year or less and (ii) contracts for which we recognize revenue at the amount to which we have the right to invoice for services performed.

 

Recent accounting pronouncements

 

In July 2017, the FASB issued Accounting Standards Update No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) Part I. Accounting for Certain Financial Instruments with Down Round Features Part II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”). Part I of this update addresses the complexity of accounting for certain financial instruments with down round features. Down round features are features of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of the entire instrument or conversion option. Part II of this update addresses the difficulty of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB Accounting Standards Codification. This pending content is the result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable non-controlling interests. ASU 2017-11 is effective for fiscal years and interim periods after December 31, 2018. The Company early adopted ASU 2017-11 effective December 31, 2017.

 

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.

 

On January 1, 2018, we adopted Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers, using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under Topic 605. Additionally, accounting for leased reader equipment is outside the scope of Topic 606, therefore our leased reader equipment revenue is recognized under ASC 840, Leases.

 

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TearLab Corporation

 

3. BALANCE SHEET DETAILS

 

Accounts receivable

 

   March 31, 2018   December 31, 2017 
         
Trade receivables  $1,869   $2,044 
Allowance for doubtful accounts   (417)   (508)
   $1,452   $1,536 

 

Inventory

 

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

 

   March 31, 2018   December 31, 2017 
         
Finished goods  $1,684   $2,125 
Inventory reserves   (1)   (127)
   $1,683   $1,998 

 

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 term purchase commitment to buy the test cards from MiniFAB (Note 8). 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.

 

Prepaid expenses and other current assets

 

   March 31, 2018   December 31, 2017 
Prepaid trade shows  $-   $14 
Prepaid insurance   213    313 
Manufacturing deposits   230    - 
Subscriptions   133    311 
Other fees and services   53    52 
   $629   $690 

 

10

 

 

TearLab Corporation

 

Fixed assets

 

   March 31, 2018   December 31, 2017 
Capitalized TearLab equipment  $7,213   $8,437 
Leasehold improvements   60    60 
Computer equipment and software   895    915 
Furniture and office equipment   437    436 
Medical equipment   1,220    1,180 
   $9,825   $11,028 
Less accumulated depreciation   (7,365)   (8,289)
   $2,460   $2,739 

 

Depreciation expense was $353 and $521 during the three months ended March 31, 2018 and 2017, respectively.

 

Accrued liabilities

 

    March 31, 2018     December 31, 2017  
Due to professionals   $ 414     $ 193  
Due to employees and directors     1,018       944  
Sales and use tax liabilities     235       253  
Royalty liability     227       447  
Warranty     129       131  
Restructuring     44       200  
Other     582       691  
    $ 2,649     $ 2,859  

 

The change in royalty liability is attributable to an amended patent license and royalty agreement with the University of California San Diego with an effective date of July 1, 2017, which reduced the royalty to 3% from 5.5% (see Note 8).

 

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TearLab Corporation

 

4. INTANGIBLE ASSETS

 

The Company’s intangible assets consist of the value of TearLab® Technology acquired in the acquisition of TearLab Research, Inc., a wholly-owned subsidiary of the 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. Amortization expense for the three months ended March 31, 2018 and 2017 was $3 and $15, respectively.

 

Intangible assets subject to amortization consist of the following:

 

  

Remaining

Useful Life

   Gross Value at   Accumulated   Net Book Value at 
   (Years)   March 31, 2018   Amortization   March 31, 2018 
                 
TearLab® technology   0   $12,172   $(12,172)  $- 
Patents and trademarks   1    271    (264)   7 
Prescriber list   0    90    (90)   - 
Total       $12,533   $(12,526)  $7 

 

   Gross Value at   Accumulated   Net Book Value at 
   December 31, 2017   Amortization   December 31, 2017 
             
TearLab® technology  $12,172   $(12,172)  $- 
Patents and trademarks   271    (261)   10 
Prescriber list   90    (90)   - 
Total  $12,533   $(12,523)  $10 

 

The estimated amortization expense for the intangible assets for the remainder of 2018 and thereafter is as follows:

 

   Amortization 
   of intangible 
   assets 
     
Remainder of 2018  $5 
Thereafter   2 
   $7 

 

5. 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 December 31, 2020 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 principle of the loan and is subject to additional accrued interest (“PIK interest”). The accrued interest can be deferred and paid together with the principle in the fifth and sixth years.

 

As part of the amended Term Loan Agreement, and funding of the second tranche, CRG received 35,000 warrants dated as of October 6, 2015 to purchase common shares of the Company at a price of $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 Sheets as of March 31, 2018 and December 31, 2017. 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. On April 7, 2017, the Company amended the Term Loan Agreement and the Company issued CRG additional warrants to purchase 35,000 common shares of the Company’s stock at $15.00 per share, which expires 5 years after issuance.

 

On April 4, 2018 with an effective date of March 31, 2018, the Company entered into an Amendment to the Term Loan Agreement. Pursuant to the terms of the Amendment, the cash interest payments due in 2018 will be deferred and added to the principal balance under the Loan Agreement at the end of each quarter. The Amendment also provides for an additional facility fee equal to 3% of the sum of the aggregate amount of the principal drawn under the Term Loan Agreement and any PIK loans issued, so that the total facility fee shall be 9.5%, applicable to the entire balance. In addition, the Amendment reduces the minimum liquidity covenant to $3 million. Concurrent with the reduction of the liquidity covenant the Company agreed to repay CRG $1.0 million of principal on the Term Loan Agreement in April 2018. Lastly, this amendment reduced the strike price of the existing CRG Warrants to $0.44 per share (see Note 6). The Amendment was accounted for as a modification in accordance with U.S. GAAP.

 

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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 October 12, 2017, the Company amended the Term Loan Agreement to change the required minimum revenue levels. The amended minimum revenue is $25,000 for 2018, $38,000 for 2019 and $45,000 for 2020. The amendment also reduced the exercise price of all of the CRG Warrants from $15.00 per share to $1.50 per share as well as provide broad anti-dilution protection such that the CRG Warrants shall maintain the same 1.22% ownership following any capital raises the Company completed through March 31, 2018. The minimum cash balance required was reduced to $3,000, subject to certain conditions.

 

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 March 31, 2018, 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 9.5% of the aggregate principal amount of the loan, including 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 Consolidated Balance Sheet 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 March 31, 2018 and related maturities of outstanding principal:

 

Principal balance outstanding  $25,000 
PIK interest   4,038 
Facility fee   880 
less discount on term loan:     
deferred financing fees, net   (284)
detachable warrants, net   (234)
   $29,400 
Less, current portion of Term loan   3,630 
Total Term Loan  $25,770 

 

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Principal due for each of the next 3 years:

 

2018  $- 
2019   14,519 
2020   15,399 
Total principal due   29,918 
Less: discount on term loan   (518)
Total term loan  $29,400 

 

6. STOCKHOLDERS’ EQUITY

 

(a) Authorized share capital

 

On October 12, 2017, the stockholders of the Company approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 9,500,000 to 40,000,000. 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.

 

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.

 

(b) Common and preferred shares

 

On December 8, 2017, the Company issued 2,013,636 shares of common stock, 2,114 shares of Series A Convertible Preferred Stock (“Preferred Stock”), Series A warrants to purchase 6,818,181 shares of common Stock (“Series A Warrants”) and Series B warrants to purchase 6,818,181 shares of common stock (“Series B Warrants”) for gross proceeds of $3,000, less issuance costs of $596. Additionally, the Company granted the placement agent compensation warrants to purchase 477,273 shares of common stock. The Preferred Stock is convertible, subject to certain limitations, into an aggregate of 4,804,545 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. The common stock, Preferred Stock, and the Series A Warrants and Series B Warrants are all included in equity in the Company’s consolidated balance sheets as of March 31, 2018 and December 31, 2017. The net proceeds were allocated to common stock, Preferred Stock, Series A Warrants and Series B Warrants based on their relative fair values as follows:

 

Common stock  $327 
Preferred stock   781 
Series A warrants   804 
Series B warrants   492 
Net proceeds  $2,404 

 

As of March 31, 2018, 1,180 shares of Series A Preferred Stock have been converted into 2,682,909 shares of common stock.

 

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(c) Stock Incentive Plan

 

On June 23, 2017, the Company’s stockholders approved an amendment to the 2002 Stock Incentive Plan (the “Stock Incentive Plan”), to increase 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. Shares granted under the Stock Incentive Plan may be either incentive stock options or non-statutory stock options. 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.

 

Share-based payment transactions with employees are recognized in the condensed consolidated 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 statements of operations and comprehensive loss (in thousands):

 

   Three months ended 
   March 31, 
   2018   2017 
         
Sales and marketing  $18   $146 
Clinical, regulatory and research and development   8    43 
General and administrative   (18)   100 
Stock-based compensation expense before income taxes  $8   $289 

 

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(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 28,601 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 purchase more than $25 worth of stock in the plan during each calendar year or purchase more than 500 shares per offering period. During the three months ended March 31, 2018 and 2017, the Company recorded $0 and $3 of expense, respectively, under the ESPP. During the three months ended March 31, 2018 and 2017, the Company issued 0 and 7,512 shares of common stock under the ESPP, respectively. In early 2018, the Company terminated the Employee Stock Purchase Plan.

 

(e) Warrants

 

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 35,000 common shares in the Company at a price of $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 March 31, 2018 and December 31, 2017. 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 three months ended March 31, 2018 or 2017.

 

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 35,000 common shares in the Company at a price of $15.00 per share and CRG was issued an additional 35,000 warrants to purchase common shares at an exercise price of $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. 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 1,253,500 shares of common stock for $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.

 

On October 12, 2017, 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 common shares in the Company at a price of $1.50 per share as well as provide broad anti-dilution protection such that the CRG Warrants shall maintain the same 1.22% ownership following any capital raises the Company completed through March 31, 2018. The modification to the terms of the CRG Warrants and 2016 CRG Warrants resulted in a change in fair value of $44 which was included as interest expense. The CRG Warrants change in fair value was calculated using the Black-Scholes Merton model with both exercise prices, assuming volatility of 94%, an expected life of 2.99 years, a risk-free interest rate of 1.70% and 0% dividend yield. The 2016 CRG Warrants change in fair value was calculated using the Black-Scholes Merton model with both exercise prices, assuming volatility of 90%, an expected life of 3.48 years, a risk-free interest rate of 1.80% and 0% dividend yield.

 

On December 8, 2017, the Company issued Series A Warrants to purchase 6,818,181 shares of common stock for $0.44 per share and Series B Warrants to purchase 6,818,181 shares of common stock for $0.44 per share in conjunction with shares of common stock and Series A Convertible Preferred stock issued on that same date. The Series A Warrants can be exercised immediately and expire 5 years after the issuance 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 88%, an expected life of 5 years, a risk free interest rate of 2.14% and a 0% dividend yield and are classified as equity on the Condensed Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017. The Series B Warrants can be exercised immediately and expire 6 months after the issuance date. Fair value of the Series B Warrants for purposes of allocating the net proceeds of the equity offering, was determined using the Black-Scholes Merton model assuming a volatility of 158.6%, an expected life of 6 months, a risk free rate of 1.45% and a 0% dividend yield and are classified as equity on the Condensed Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017. In addition, we granted the placement agent compensation warrants to purchase 477,273 shares of common stock at $0.55 per share. The compensation warrants are in the same form as Series A Warrants, excluding the exercise price, and will terminate on the five year anniversary date. The placement agent warrants are classified as equity on the Condensed Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017.

 

In connection with the offering the Company issued CRG warrants to purchase 83,240 shares of common stock at an exercise price of $1.50 (“2017 CRG Warrants”) as a result of triggering the anti-dilution clause of the debt amendment (see Footnote 5 for additional information). The anti-dilution clause is considered down-round protection, however the Company early adopted ASU 2017-11 and therefore the down-round feature is excluded from the consideration of whether the warrants are indexed to the Company’s own stock and therefore the warrants are not required to be liabilities under the guidance. The 2017 CRG Warrants are classified as equity on the Condensed Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017 and were valued at $30 upon issuance using the Black-Scholes Merton model assuming volatility of 88%, an expected life of 5 years, a risk-free interest rate of 2.14% and 0% dividend yield.

 

In March 2018, in connection with the amended Term Loan Agreement, the existing CRG warrants had a change in strike price to $0.44. The modification to the terms of the CRG Warrants resulted in a change in fair value of $10 which was included as interest expense.

 

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7. NET INCOME (LOSS) PER SHARE

 

Basic earnings per share (“EPS”) excludes dilutive securities and is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding for the year. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted and the resulting additional shares are dilutive because their inclusion decreases the amount of EPS.

 

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

 

(in thousands of shares)  As of March 31, 
   2018   2017 
Stock options   629    706 
Warrants   15,520    1,324 
ESPP shares   -    3 
Convertible preferred shares   1    102 
           
Total   16,150    2,135 

 

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 December 31, 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.

 

On May 1, 2018 with an effective date of July 1, 2017 the Company entered into a Restated License Agreement (the “Agreement”) to its exclusive license agreement for the commercial development of the invention disclosed in UCSD Disclosure Docket No. SD2002-180 and titled “Volume Independent Tear Film Osmometer” (UCSD License Agreement #2003-03-0433), dated as of March 12, 2003, as amended by Amendment 1, dated as of June 9, 2003, Amendment 2, dated as of September 5, 2005, Amendment 3, dated as of July 7, 2006, Amendment 4, dated as of October 9, 2006, and Amendment 5, dated as of July 9, 2007, by and among the Company and The Regents of the University of California (collectively the “Existing License”) to amend certain terms related to royalties under the Agreement and treatment upon a change of control transaction. The Company is required to make royalty payments of anywhere from 3% to 4.25% based on quarterly net sales. Additionally, the Company is required to pay a royalty of 20% of any sublicense fees it receives. Should a change of control transaction occur during the term of the agreement the royalty rates would range anywhere from 3.5% to 4.75% based on quarterly net sales and the Company would have to make a milestone payment of $0.5 million. In addition, if the Company has not commenced commercial sales of the TearLab DiscoveryTM Platform on or before July 1, 2019 the Company will be required to pay a milestone payment of 1.25% of cumulative net sales for the two year period following the effective date of the amendment.

 

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Effective October 1, 2006 the Company entered into a second 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.

 

Future minimum royalty payments under this agreement as of March 31, 2018 are as follows:

 

2018  $35 
2019   35 
2020   35 
2021   35 
2022   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, for the purchase and delivery of individual osmolarity test cards with the freight costs borne by MiniFab. The Company has the benefit of a lower purchase price that will remain in place until the earlier of, the Company reaches an annual volume of 4.5 million test cards or March 31, 2018. Certain savings from freight costs will remain in place throughout the agreement. The Supply Agreement requires, 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 August 2011 agreement between MiniFAB and the Company.

 

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.

 

Contingencies

 

We are not currently a party to any litigation, nor are we aware of any pending or threatened litigation against us, that we believe would materially affect our business, operating results, financial condition or cash flows. Our industry is characterized by frequent claims and litigation including securities litigation, claims regarding patent and other intellectual property rights and claims for product liability. As a result, in the future, we may be involved in various legal proceedings from time to time.

 

We initiated a patent infringement lawsuit against i-Med Pharma, Inc. in February 2016 alleging infringement of our Canadian patent. In February 2018, the Federal Court of Canada issued a ruling in favor of i-Med Pharma, Inc. which invalidated specific claims in our Canadian patent which were alleged to be infringed. We are appealing this ruling to the Canadian Federal Appellate Court. As part of the ruling, the Federal Court ruling awarded costs to i-Med Pharma, Inc., for $0.5 million. The final $0.2 million was paid in April 2018. We do not believe the outcome of this litigation will materially affect our business, operating results, financial condition or cash flows.

 

9. RESTRUCTURING COSTS

 

On December 15, 2017 the Company approved a new business model to maintain its current customer and annuity revenue base, focus resources on the development and generation of clinical data for our next generation TearLab DiscoveryTM Platform and reduce the Company’s cash burn rate. In connection with the restructuring the Company recorded restructuring expenses of $322 primarily related to employee cost and one-time contract termination costs at December 31, 2017. Liabilities related to the restructuring are included in accrued liabilities in the Condensed Consolidated Balance Sheet. The following table summarizes the activity related to the restructuring during the three months ended March 31, 2018:

 

   Employee Costs   Other Costs   Total 
Accrued obligations as of December 31, 2017  $97   $103   $200 
Settlement of obligations   (75)   (59)   (134)
Accrued obligations as of March 31, 2018  $22   $44   $66 

 

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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 an in-vitro diagnostic company that has commercialized a proprietary tear testing platform, the TearLab® Osmolarity System that enables eye care practitioners to test for a highly sensitive and specific biomarker 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. 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 purchase commitment or implied minimum purchase commitment of disposable test cards over the related contract term (which we refer 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”).

 

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. In connection with the CE mark clearance, we have entered into multi-year agreements with numerous distributors for distribution of the TearLab® Osmolarity System. Currently, we have signed distribution agreements in Central and South America, Europe, Asia, Canada, and Australia. We sell directly to the customer in the United States.

 

On January 4, 2018, we announced that we had submitted a 510(k) application to the FDA for the potential clearance of the TearLab DiscoveryTM Platform. The submission covers Discovery and the MMP-9 biomarker. On February 14, 2018, we announced that the application had successfully passed the acceptance review phase with the FDA. On April 11, 2018 we announced that we received written feedback from the FDA, requesting that we provide additional information to establish correlation to the FDA-cleared predicate chosen to establish 510(k) substantial equivalence. We plan to submit our response to the FDA’s comments sometime in the third quarter of 2018, within the allowed 180-day timeframe. After securing FDA clearance, TearLab intends to pursue a CLIA waiver in an effort to prepare for commercialization in the US market.

 

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RESULTS OF OPERATIONS

 

Revenue, Cost of Sales and Gross Margin

 

(in thousands)  Three months ended
March 31,
 
   2018   2017   Change 
             
TearLab revenue  $6,446   $6,701   $(255)
TearLab – cost of sales   2,124    3,008    (884)
TearLab gross profit   4,322    3,693    629 
Gross profit percentage   67%   55%     

 

Revenue

 

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 dry eye disease (“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.

 

Having received 510(K) clearance and a CLIA waiver from the FDA in the United States, we sell to customers in the United States who hold CLIA licenses and actively support and assist our customers to obtain their licenses or provide them with support from certified professionals. This CLIA waiver documentation allows us to sell our product to the approximately 50,000 eye care practitioners in the United States that are candidates to operate under a CLIA waiver certification.

 

We are working with our established distributors in Central and South America, Europe, Asia, Canada, and Australia to increase sales. The ability for reimbursement to be obtained in many of the countries where we have distributors will facilitate our ability to increase sales and stimulate the commercialization process. In countries where we have distributors, we are supporting physicians in local clinical trials and providing them with the required guidance to understand the relationship between DED and osmolarity and how to manage their patients with objective diagnostic data.

 

TearLab revenue for the three months ended March 31, 2018 was $6.4 million compared to $6.7 million for the three months ended March 31, 2017. This decrease was driven by the decrease in reader revenue compared to first quarter of 2017 as well as the termination of the PRN Physicians Recommended Nutriceuticals, LLC, cooperative marketing agreement in June 2017 and partially offset by a slight increase in test card utilization.

 

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Cost of Sales

 

TearLab cost of sales includes costs of goods sold, depreciation of 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 cost of sales for the three months ended March 31, 2018 decreased $0.9 million or 29% for the three months ended March 31, 2018 compared to March 31, 2017. The Company entered into a restated patent license and royalty agreement with the University of California San Diego with an effective date of July 1, 2017 that reduced cost of sales by $0.5 million. In addition, the decrease in cost of sales was driven by reduced reader deprecation related to fixed asset impairment recorded in December 2017 and lower revenue volume.

 

Gross Profit

 

TearLab gross profit for the three months ended March 31, 2018 was $4.3 million compared to the $3.7 million for the three months ended March 31, 2017. The gross profit percentage of revenue for the three months ended March 31, 2018 was 67% compared to 55% for the three months ended March 31, 2017. The improvement in gross profit percentage was driven by the restated patent license and royalty agreement with the University of California San Diego, discussed in Note 8 of the Notes to the Unaudited Condensed Consolidated Financial Statements for the three months ended March 31, 2018 and included in Item 1. Excluding the $0.5 million impact of the restated agreement, gross profit percentage would have been 59% for the three months ended March 31, 2018. Additionally, the change in gross profit was driven by the reduced depreciation due to fixed asset impairment of reader systems recorded in fourth quarter of 2017.

 

Operating Expenses

 

(in thousands)  Three months ended March 31, 
   2018   2017   Change 
             
Sales and marketing  $1,020   $3,332   $(2,312)
Clinical, regulatory and research and development   1,041    1,564    (523)
General and administrative   2,044    2,187    (143)
Operating expenses  $4,105   $7,083   $(2,978)

 

Sales and Marketing Expense

 

Sales and marketing expenses decreased by $2.3 million or 69% in the three months ended March 31, 2018, as compared with the three months ended March 31, 2017. The reduction in sales and marketing expenses is attributable to cost savings from our December 2017 organizational restructuring and the launch of our new business model aimed at reducing costs.

 

Clinical, Regulatory and Research and Development Expenses

 

Total clinical, regulatory and research and development expenses decreased $0.5 million or 33.4% in the three months ended March 31, 2018 as compared with the three months ended March 31, 2017. The decrease in expense was primarily due to lower development cost of the TearLab DiscoveryTM Platform.

 

General and Administrative Expenses

 

Total general and administrative expenses decreased $0.1 million or 6.5% in the three months ended March 31, 2018 as compared with the three months ended March 31, 2017. The decrease was primarily due to the launch of our new business model that is aimed at reducing costs.

 

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Other Income (Expense)

 

(in thousands)  Three Months Ended
March 31,
 
   2018   2017   Change 
             
Interest income (expense)  $(1,105)  $(1,028)  $(77)
Other (net)   5    (3)   8 
Other income  $(1,100)  $(1,031)  $(69)

 

Interest Income (Expense)

 

Interest expense for the three months ended March 31, 2018 and 2017 was from our long-term debt under the Term Loan Agreement. Interest expense increased for the three months ended March 31, 2018 when compared to the same period in the previous fiscal year based on larger average balances of long-term debt outstanding, the impact of the updated strike price of the warrants issued to the lenders, and changes to the facility fee.

 

Other (net)

 

Other income (loss) for the three months ended March 31, 2018 and 2017 consists primarily of foreign exchange transaction gains and losses, based on fluctuations of the Company’s foreign denominated currencies.

 

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Liquidity and Capital Resources

 

(in thousands)  March 31, 2018   December 31, 2017   Change 
Cash and cash equivalents  $7,431   $7,272   $159 
Percentage of total assets   54.2%   50.7%     
                
Working capital  $3,809   $6,875   $(3,066)

 

Financial Condition

 

In December 2017 TearLab raised $3 million in gross proceeds through a registered direct offering to support our operations and regulatory expenses. In addition, in April 2018, with an effective date of March 31, 2018, we renegotiated our Term Loan Agreement with CRG. This new agreement lowers the minimum liquidity requirement from an end of the day cash balance of $5 million to $3 million and it defers cash interest payments due in 2018. These changes will allow our current funding to provide us with the time needed to gain our 510(k) approval for the Discovery™ Platform from the FDA as the Discovery™ Platform is critical to our success moving forward. Based on our current rate of cash consumption in addition to our projections, we estimate we will need additional capital in the first quarter of 2019. Our prospects for obtaining that capital are uncertain. Due to 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. 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:

 

  Our ability to execute our commercial strategy with our current resources, under our new business model
  the cost and results of continuing development of our next generation TearLab Discovery™ Platform including the cost of suppliers and service providers that require advance payment;
  whether government and third-party payers agree to continue reimbursement of the TearLab ® Osmolarity System at current levels;
  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.

 

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 and/or continue the development of the TearLab Discovery™ Platform.

 

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Indebtedness

 

On March 4, 2015, the Company executed the Term Loan Agreement with CRG as lenders providing the Company with access of up to $35.0 million under the Term Loan Agreement. The Company entered into a second amendment to the Term Loan Agreement with CRG on August 6, 2015. The Company 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 trailing twelve-month revenue prior to June 30, 2016, as required to access the third tranche. As part of the second amendment to the Term Loan Agreement, CRG received warrants to purchase 35,000 common shares in the Company at a price of $50.00 per share (as adjusted for a 1-for-10 reverse stock split). 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.

 

On October 12, 2017, the Term Loan Agreement was further amended, under the fifth amendment, to change the required minimum revenue levels to $25 million for 2017 and 2018. In addition, subject to the condition of raising net equity proceeds of at least $7 million by March 31, 2018, the Amendment changes the definition of “Interest-only Period” and “PIK Period” from the sixteenth payment date to the twentieth payment date following the first borrowing date, which has the effect of extending the “Interest-only Period” and the “PIK” period throughout the calendar year 2019. Also, pursuant to the Amendment, the Company agreed to amend the warrants previously issued by the Company to CRG to (i) reduce the strike price to $1.50 per share and (ii) to include broad based anti-dilution protection such that the warrants shall maintain the same 1.22% ownership percentage following any capital raises the Company may complete through March 31, 2018.

 

On April 4, 2018, effective March 31, 2018, the Term Loan Agreement was further amended, under the sixth amendment to reduce the minimum liquidity covenant to $3 million, defer 2018 cash interest payments and add them to the outstanding principal amount of the loan and increase the facility fee by 3% to 9.5% and apply to the entire balance. In addition, CRG will now be able to designate a non-voting observer to attend all meetings and receive the same documents as other directors. This amendment also states that the exercise price of the warrants CRG received will be reduced to $0.44 cents per share and the borrower must repay $1 million of its principal.

 

The Term Loan Agreement 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. The minimum annual revenue threshold level required by the Term Loan Agreement for calendar year 2018 is $25.0 million. The minimum cash balance required is $3.0 million, subject to certain conditions.

 

If the Company does not have annual revenue greater or equal to the annual revenue covenant in a calendar year, the Company 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 the Company does not achieve the minimum revenue threshold and it cannot complete the CRG Equity Cure, it 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.

 

Ongoing Sources and Uses of Cash

 

We anticipate that our cash and cash equivalents and cash generated from revenue will be sufficient to sustain our operations into the first quarter of 2019. We continually evaluate various financing possibilities but we typically expect our primary sources of cash will be related to the collection of accounts receivable. Our accounts receivable collections will be impacted by our ability to maintain current customers and annuity revenue base, while reducing costs as per our new business model.

 

We expect our primary uses of cash will be to fund our operating expenses and the development and generation of clinical data for our next generation platform.

 

Changes in Cash Flows

 

Cash Provided by Operating Activities

 

Net cash provided by operating activities during the three months ended March 31, 2018 was $0.2 million. Net cash provided by operating activities during the three month period was more than our net loss of $0.9 million primarily due to the depreciation of fixed assets, and deferred interest and the amortization of the discount on our long-term debt. In aggregate, these non-cash items totaled $1.5 million.

 

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The net change in working capital and non-current asset balances related to operations for the three months ended March 31, 2018 and 2017 consists of the following:

 

   Three Months Ended 
(in thousands)  March 31, 
   2018   2017 
Changes in operating assets and liabilities:          
           
Accounts receivable, net  $84   $13 
Inventory   314    (131)
Prepaid expenses and other assets   111    10 
Accounts payable   (647)   889 
Accrued liabilities   (210)   123 
Deferred rent/revenue   (8)   (12)
   $(356)  $892 

 

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

 

Inventory levels of test cards on hand decreased in the three months ended March 31, 2018 due to the management of on hand inventory based on 2018 projections; and
   
Accounts payable and accrued liabilities had a net decrease during the three months ended March 31, 2018 due to the management of spending based on our new business model as well as the amended patent license and royalty agreement with the University of California San Diego that reduced accounts payable and accrued liabilities by $0.5 million for the three months ended March 31, 2018.

 

Cash Used in Investing Activities

 

Net cash used in investing activities for the three months ended March 31, 2018 and 2017 was $0.1 million and $0.2 million, respectively, to acquire fixed assets.

 

Cash Provided by Financing Activities

 

There was $0 in net cash provided by financing activities during the three months ended March 31, 2018. For the three months ended March 31, 2017, there was $0.03 million net cash provided by financing activities.

 

Off-Balance-Sheet Arrangements

 

As of March 31, 2018, we did not have any material off-balance-sheet arrangements as defined in Item 303(1)(4)(ii) of SEC Regulation S-K.

 

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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 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 three months ended March 31, 2018 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, 2017. 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 months ended March 31, 2018 included in Item 1.

 

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 months ended March 31, 2018 included in Item 1.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

Currency Fluctuations and Exchange Risk

 

Our sales are denominated primarily in U.S. dollars. Most of our expenses are denominated in U.S. dollars, however, a minor portion of our other expenses are in Canadian dollars, Australian dollars, Euro and pounds sterling. We cannot predict any future trends in the exchange rate of the Canadian dollar, Australian dollar, euro or pound sterling against the U.S. dollar. Any strengthening of the Canadian dollar, Australian 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 is advisable to offset these risks.

 

Interest Rate Risk

 

Our long-term debt carries a fixed rate of 13% interest. A decrease in market interest rates would increase the fair value of our long-term debt.

 

ITEM 4. 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.

 

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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 March 31, 2018 our disclosure controls and procedures were effective at the reasonable assurance level.

 

(b) Changes in Internal Control over Financial Reporting.

 

During the first quarter of 2018, 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.

 

We are not currently a party to any litigation, nor are we aware of any pending or threatened litigation against us that we believe would materially affect our business, operating results, financial condition or cash flows. However, our industry is characterized by frequent claims and litigation including securities litigation, claims regarding patent and other intellectual property rights and claims for product liability. As a result, in the future, we may be involved in various legal proceedings from time to time.

 

We initiated a patent infringement lawsuit against i-Med Pharma, Inc. in February 2016 alleging infringement of our Canadian patent. In February 2018, the Federal Court of Canada issued a ruling in favor of i-Med Pharma, Inc. which invalidated specific claims in our Canadian patent which were alleged to be infringed. We are appealing this ruling to the Canadian Federal Appellate Court. As part of the ruling, the Federal Court ruling awarded costs to i-Med Pharma, Inc., for $0.5 million. The final $0.2 million was paid in April 2018. We do not believe that the outcome of this litigation will materially affect our business, operating results, financial condition or cash flows.

 

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ITEM 1A. RISK FACTORS.

 

Risks Relating to Our Financial Condition

 

We may need to raise additional capital in the future. Such capital, 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.

 

Based on a revised operating model that we implemented in December 2017, we expect that we will need to raise additional capital prior to the end of the first quarter of 2019. This estimate is subject to risk based primarily on our success in implementing the revised operating model, maintaining certain revenue levels despite a reduction in our commercial resources that was made in order to reduce our cash burn and accurately forecasting the remaining development expenses required to gain FDA clearance of our next generation diagnostic platform, and we cannot assure you that we will be successful in implementing this new model. Any financings undertaken to raise needed capital 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. If access to sufficient capital is not available as and when needed, our business will be materially impaired and we may be required to cease operations, curtail product development, manufacturing improvements, or sales generation programs, attempt to obtain funds through licensing certain technologies or products, or we may be required to significantly reduce expense, sell assets, seek a merger or joint venture partner, file for protection from creditors, liquidate all our assets or cease operations and wind down our business.

 

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 going concern.

 

We have prepared our condensed 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 and there is substantial doubt about our ability to continue as a going concern. We do not currently have any available borrowing under our term loan or credit facility. Our condensed 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 March 31, 2018, we had an accumulated deficit of $529.7 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 or receive approval to commercialize our next generation TearLab DiscoveryTM Platform on a scale that will allow us to achieve and sustain profitability. 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.

 

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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.

 

On March 4, 2015, we executed a term loan agreement with CRG as lenders (the “Term Loan 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 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, facility fee, 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, 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 Term Loan Agreement contains 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 Agreement are $25.0 million, $38.0 million and $45.0 million for calendar years 2018, 2019 and 2020, respectively. The minimum cash balance required is $3.0 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 cure by raising subordinated debt or equity 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 described above, if required. In addition, in the event of our breach of the Term Loan Agreement, 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.

 

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

 

Our existing Term Loan Agreement 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.

 

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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 or fiscal year;
  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 in 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.

 

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.

 

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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 commercialized 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. 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 March 31, 2018, our total liabilities were $33.2 million including $25.8 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, 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;
  our liabilities could cause our suppliers to change their payment terms, require us to pay for needed goods or services in advance or choose not to do business with us at all which could negatively impact our cash flows, supply chain and our ability to supply products to our customers when needed; 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.

 

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 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.

 

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We continue to 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 bring 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:

 

  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.
  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.
  We may be unable to achieve widespread acceptance of the TearLab® Osmolarity System among physicians as a result of our inability to establish adequate sales and marketing capabilities, address competition effectively, obtain and enforce patents to protect proprietary rights from use by would-be competitors, retain key personnel, maintain adequate reimbursement for our product to support our pricing policies and ensure sufficient manufacturing capacity and inventory to support commercialization plans.

 

Our business is subject to health care industry 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 being unable to obtain approval for payment from these third-party payers. If patients 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.

 

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 payer rates paid to laboratories for lab tests, which will be used to calculate Medicare payment rates. This final rule announced CMS’ decision to move the implementation date for the private payer rate-based fee schedule to January 1, 2018. Reporting entities, which would primarily be certain qualifying customers in the U.S. that derive a certain percentage and volume of their revenue from laboratory tests from Medicare, will report private payer rates for our laboratory tests which will serve under the act as a baseline for future reimbursement. Our product was only minimally impacted by PAMA for the year 2018 through 2020. However, should reimbursement for our products be reduced as a result of PAMA or other cost savings initiatives, this could negatively impact our pricing and commercialization of our products in the U.S.

 

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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 will 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.

 

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.

 

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.

 

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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.

 

We have applied for, and intend to continue to apply for, patents relating to the TearLab® Osmolarity System 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 generic products.

 

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. For example, we have recently been 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.

 

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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.

 

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.

 

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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 suppliers products 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. Although we have no direct competitors, we have numerous potential competitors in the United States and 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.

 

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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 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.

 

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.

 

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 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.

 

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TearLab Corporation

 

Risks Related to Our Common Stock

 

Our common stock was delisted from The Nasdaq Capital Market, which could make trading in our common stock more difficult for investors, potentially leading to declines in our share price and liquidity and could limit our ability to raise additional capital.

 

Effective at the open of business on November 9, 2017, our common stock was suspended and effectively delisted from The Nasdaq Capital Market and began trading on the OTCQB. The delisting was the result of our non-compliance with Nasdaq Listing Rule 5550(b).

 

Our delisting from The 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 The 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 will likely be made more difficult and the trading volume and liquidity of our stock could decline. Our delisting from The 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 impact the acceptance of our common stock as currency or the value accorded by other parties. Further, following our delisting, we will 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.

 

Now that our common stock is traded on an over the counter quotation system, an investor may find it more difficult to sell our stock or obtain accurate quotations as to the market value of our common stock.

 

Following the delisting of our common stock, our common stock now falls within the definition of a “penny stock” as defined in the Securities Exchange Act of 1934, or the Exchange Act, and is covered by Rule 15g-9 of the Exchange Act. Rule 15g-9 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 will affect the ability or willingness of broker-dealers to sell our securities, and accordingly will 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. In addition, the fact that our common stock now trades on the OTCQB market could contribute to trading volumes in our shares being sporadic and volatility in the share price. If adverse market conditions exist, you may have difficulty selling your shares. The market price of our common shares may fluctuate significantly due to a variety of factors, including:

 

  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;
  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;
  political instability, natural disasters, war and/or events of terrorism; and
  the impact of our delisting from The Nasdaq Capital Market.

 

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.

 

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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.

 

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.

 

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

 

None.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

 

Not applicable.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION.

 

None.

 

ITEM 6.EXHIBITS

 

Exhibit

Number

  Exhibit Description   Incorporated by Reference
10.1   Amendment to the Term Loan Agreement, dated as of March 4, 2015 as amended by the Omnibus Amendment Agreement, dated as of April 2, 2015, Amendment 2, dated August 6, 2015, Amendment 3, dated December 31, 2015, and Amendment 4, dated April 7, 2016, Amendment 5, dated October 12, 2017 by and among TearLab Corporation, certain of its subsidiaries from time to time party thereto as guarantors and CRG LP (formerly known as Capital Royalty) and certain of its affiliate funds, as lenders, dated as of March 31, 2018.    
         
10.2#   Employment Agreement, dated as of March 30, 2018 by and between the Registrant and Michael Marquez.    
         
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*   SXBRL Taxonomy Extension Presentation    

 

# Management compensatory plan, contracts or arrangement.

 

*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

 

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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: May 11, 2018 /s/ Joseph Jensen
  Joseph Jensen
  Chief Executive Officer

 

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EX-10.1 2 ex10-1.htm

 

Execution Version

 

AMENDMENT 6 TO TERM LOAN AGREEMENT

 

THIS AMENDMENT 6, dated as of April 4, 2018 and effective as of March 31, 2018 (this “Amendment”), is made among TearLab Corporation, a Delaware corporation (“Borrower”), the subsidiary guarantors listed on the signature pages hereof under the heading “SUBSIDIARY GUARANTORS” (each a “Subsidiary Guarantor” and, collectively, the “Subsidiary Guarantors”) and the lenders listed on the signature pages hereof under the heading “LENDERS” (each a “Lender” and, collectively, the “Lenders”), with respect to the Loan Agreement referred to below.

 

RECITALS

 

WHEREAS, the Borrower and the Lenders are parties to a Term Loan Agreement, dated as of March 4, 2015, as amended by the Omnibus Amendment Agreement, dated as of April 2, 2015, Amendment 2, dated as of August 6, 2015, Amendment 3, dated as of December 31, 2015, Amendment 4, dated as of April 7, 2016, and Amendment 5, dated as of October 12, 2017 (the “Loan Agreement”), with the Subsidiary Guarantors from time to time party thereto.

 

WHEREAS, the Borrower has requested, and the Lenders have agreed, on the terms and subject to the conditions set forth herein, to amend the Loan Agreement.

 

NOW, THEREFORE, in consideration of the mutual agreements, provisions and covenants contained herein, the parties agree as follows:

 

SECTION 1. Definitions; Interpretation.

 

(a) Terms Defined in Loan Agreement. All capitalized terms used in this Amendment (including in the recitals hereof) and not otherwise defined herein shall have the meanings assigned to them in the Loan Agreement.

 

(b) Interpretation. The rules of interpretation set forth in Section 1.03 of the Loan Agreement shall be applicable to this Amendment and are incorporated herein by this reference.

 

SECTION 2. Amendment. Subject to Section 3:

 

(a) Section 3.02(c) of the Loan Agreement is hereby amended by adding the following sentences to the end thereof:

 

“Notwithstanding the foregoing sentence or any other provision of the Loan Documents to the contrary, Borrower shall not be required to pay, in cash, accrued interest on the Loans that would otherwise be payable on each Payment Date between (and including) March 31, 2018 through (and including) December 31, 2018 (such period being the “Deferral Period” and such interest being the “Deferral Period Interest”). Instead, the Deferral Period Interest payable on any Payment Date during the Deferral Period shall be added to the outstanding principal amount of the Loans as of such Payment Date, and such increased outstanding principal amount shall continue to accrue interest in accordance with the provisions of this Agreement, at the rate of 13.00% per annum; provided, however, that interest payable at the Default Rate shall be payable from time to time in cash and on demand.”

 

 
 

 

(b) Section 8.10 of the Loan Agreements is amended and restated in its entirety as follows:

 

8.10 Board Observation Rights. Borrower shall, concurrently with delivery to Borrower’s Board of Directors (the “Board”), give a designated representative of the Lenders (who may change from time to time at the sole discretion of CRG Servicing LLC, as agent for Lenders) (the “Representative”) copies of all notices, minutes, consents and other material that Borrower provides to its directors, and shall permit the Representative to attend all meetings of the Board as a non-voting observer, except that the Representative may be excluded from access to any material or meeting or portion thereof if the Board determines in good faith, upon advice of counsel, that such exclusion is reasonably necessary to preserve attorney-client privilege or to protect highly confidential proprietary information. Upon reasonable notice and at a scheduled meeting of the Board or such other time, if any, as the Board may determine in its sole discretion, the Representative may address the Board with respect to a Lender’s concerns regarding significant business issues facing Borrower.”

 

(d) Section 9.01 of the Loan Agreement is amended as follows:

 

(i) Clause (g) thereof is amended and restated in its entirety as follows:

 

“(g) [Reserved].”;

 

(ii) Clause (h) thereof is amended by replacing the phrase “, when added to the aggregate principal amount of the outstanding Indebtedness permitted in reliance on Section 9.01(g), does not exceed $500,000” appearing in subclause (ii) with the phrase “does not exceed $200,000”; and

 

(iii) Clause (n) thereof is amended and restated in its entirety as follows:

 

“(n) [Reserved].”

 

(e) Section 9.03(e) of the Loan Agreement is amended by amending and restating such clause in its entirety as follows:

 

“(e) [Reserved].”

 

(f) Section 9.05 of the Loan Agreement is amended as follows:

 

(i) Clause (f) thereof is amended by deleting the phrase “(i) Investments by any Obligor in any Subsidiary of Borrower that is not a Subsidiary Guarantor, when added to Asset Sales permitted in reliance on Section 9.09(d)(ii), not exceeding $1,500,000 in the aggregate at any time; and (ii)”;

 

2
 

 

(ii) Clause (k) thereof is amended by replacing the “; and” at the end thereof with “.”; and

 

(iii) Clause (l) thereof is deleted in its entirety.

 

(g) Section 9.09 of the Loan Agreement is amended as follows:

 

(i) Clause (d) thereof is amended and restated in its entirety as follows:

 

“(d) transfers of Property by any Subsidiary to any Obligor on arm’s length terms or for reasonably equivalent value;”;

 

(ii) Clause (g) thereof is amended by adding the word “and” at the end thereof;

 

(iii) Clause (h) thereof is amended by replacing the “; and” at the end thereof with “.”; and

 

(iv) Clause (i) thereof is amended by replacing the amount “$500,000” therein with “$50,000”.

 

(h) Section 10.01 of the Loan Agreement is amended and restated in its entirety as follows:

 

Minimum Liquidity. Borrower shall maintain at all times Liquidity in an amount in excess of the greater of (i) $3,000,000 and (ii) the minimum cash balance that Borrower is required to maintain pursuant to any working capital revolving credit facility to which Borrower is a party and that is secured by Borrower’s accounts receivable (provided, however, that for greater certainty, Borrower shall not be permitted to enter into any such facility without the consent of the Lenders in accordance with the terms of this Agreement).”

 

SECTION 3. Conditions of Effectiveness.

 

(a) The effectiveness of Section 2 shall be subject to the following conditions precedent:

 

(i) The Warrants shall have been amended to revise the strike price to $0.44 per share.

 

(ii) The Fee Letter shall have been amended in form and substance satisfactory to the Lenders.

 

(iii) The Borrower shall have prepaid the Loans in part, in the principal amount of $1,000,000, and shall have paid accrued but unpaid interest on such principal being prepaid; provided, however, that the Borrower shall not be required to pay any Prepayment Premium or Facility Fee (as defined in the Fee Letter, as amended to date) with respect to such prepayment.

 

3
 

 

(iv) The Borrower shall have paid or reimbursed Lenders for Lenders’ reasonable out of pocket costs and expenses incurred in connection with this Amendment, including Lenders’ reasonable and documented out of pocket legal fees and costs, pursuant to Section 12.03(a)(i)(z) of the Loan Agreement.

 

(v) The representations and warranties in Section 4 shall be true in all material respects on the date hereof and on the first date on which the conditions set forth in Section 3 shall have been satisfied.

 

SECTION 4. Representations and Warranties; Reaffirmation.

 

(a) The Borrower hereby represents and warrants to each Lender as follows:

 

(i) The Borrower has full power, authority and legal right to make and perform this Amendment. This Amendment is within the Borrower’s corporate powers and has been duly authorized by all necessary corporate and, if required, by all necessary shareholder action. This Amendment has been duly executed and delivered by the Borrower and constitutes a legal, valid and binding obligation of the Borrower, enforceable against the Borrower in accordance with its terms, except as such enforceability may be limited by (a) bankruptcy, insolvency, reorganization, moratorium or similar laws of general applicability affecting the enforcement of creditors’ rights and (b) the application of general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law). This Amendment (x) does not require any consent or approval of, registration or filing with, or any other action by, any Governmental Authority or any third party, except for such as have been obtained or made and are in full force and effect, (y) will not violate any applicable law or regulation or the charter, bylaws or other organizational documents of the Borrower and its Subsidiaries or any order of any Governmental Authority, other than any such violations that, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect, (z) will not violate or result in an event of default under any material indenture, agreement or other instrument binding upon the Borrower and its Subsidiaries or assets, or give rise to a right thereunder to require any payment to be made by any such Person.

 

(ii) No Default has occurred or is continuing or will result after giving effect to this Amendment.

 

(iii) The representations and warranties made by or with respect to the Borrower in Section 7 of the Loan Agreement are true in all material respects (taking into account any changes made to schedules updated in accordance with Section 7.21 of the Loan Agreement or attached hereto), except that such representations and warranties that refer to a specific earlier date were true in all material respects on such earlier date.

 

(iv) There has been no Material Adverse Effect since the date of the Loan Agreement.

 

(v) As of the date hereof, the Warrants represent 1.22% of Borrower’s fully diluted shares outstanding.

 

4
 

 

(b) The Borrower hereby ratifies, confirms, reaffirms, and acknowledges its obligations under the Loan Documents to which it is a party and agrees that the Loan Documents remain in full force and effect, undiminished by this Amendment, except as expressly provided herein. By executing this Amendment, the Borrower acknowledges that it has read, consulted with its attorneys regarding, and understands, this Amendment.

 

SECTION 5. Governing Law; Submission to Jurisdiction; Waiver of Jury Trial.

 

(a) Governing Law. This Amendment and the rights and obligations of the parties hereunder shall be governed by, and construed in accordance with, the law of the State of New York, without regard to principles of conflicts of laws that would result in the application of the laws of any other jurisdiction; provided that Section 5-1401 of the New York General Obligations Law shall apply.

 

(b) Submission to Jurisdiction. The Borrower agrees that any suit, action or proceeding with respect to this Amendment or any other Loan Document to which it is a party or any judgment entered by any court in respect thereof may be brought initially in the federal or state courts in Houston, Texas or in the courts of its own corporate domicile and irrevocably submits to the non-exclusive jurisdiction of each such court for the purpose of any such suit, action, proceeding or judgment. This Section 5 is for the benefit of the Lenders only and, as a result, no Lender shall be prevented from taking proceedings in any other courts with jurisdiction. To the extent allowed by applicable Laws, the Lenders may take concurrent proceedings in any number of jurisdictions.

 

(c) Waiver of Jury Trial. The Borrower and each Lender hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any suit, action or proceeding arising out of or relating to this Amendment, the other Loan Documents or the transactions contemplated hereby or thereby.

 

SECTION 6. Miscellaneous.

 

(a) No Waiver. Nothing contained herein shall be deemed to constitute a waiver of compliance with any term or condition contained in the Loan Agreement or any of the other Loan Documents or constitute a course of conduct or dealing among the parties. Except as expressly stated herein, the Lenders reserve all rights, privileges and remedies under the Loan Documents. Except as amended hereby, the Loan Agreement and other Loan Documents remain unmodified and in full force and effect. All references in the Loan Documents to the Loan Agreement shall be deemed to be references to the Loan Agreement as amended hereby.

 

(b) Severability. In case any provision of or obligation under this Amendment shall be invalid, illegal or unenforceable in any jurisdiction, the validity, legality and enforceability of the remaining provisions or obligations, or of such provision or obligation in any other jurisdiction, shall not in any way be affected or impaired thereby.

 

(c) Headings. Headings and captions used in this Amendment (including the Exhibits, Schedules and Annexes hereto, if any) are included for convenience of reference only and shall not be given any substantive effect.

 

5
 

 

(d) Integration. This Amendment constitutes a Loan Document and, together with the other Loan Documents, incorporates all negotiations of the parties hereto with respect to the subject matter hereof and is the final expression and agreement of the parties hereto with respect to the subject matter hereof.

 

(e) Counterparts. This Amendment may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument and any of the parties hereto may execute this Amendment by signing any such counterpart.

 

(f) Controlling Provisions. In the event of any inconsistencies between the provisions of this Amendment and the provisions of any other Loan Document, the provisions of this Amendment shall govern and prevail. Except as expressly modified by this Amendment, the Loan Documents shall not be modified and shall remain in full force and effect.

 

[Remainder of page intentionally left blank]

 

6
 

 

IN WITNESS WHEREOF, the parties hereto have duly executed this Amendment, as of the date first above written.

 

 

7
 

 

 

 

8
 

 

EX-10.2 3 ex10-2.htm

 

 

April 2nd, 2018

 

Dear Michael:

 

Congratulations! This letter represents formal notification of your promotion to Interim Chief Financial Officer effective April 2, 2018.

 

The annual salary for the position will be $190,000.00. If you accept, your new wages will be reflected in the next payroll cycle April 15, 2018. All normal deductions such as federal, state, social security and Medicare will continue. If you wish to change any exemptions claimed on your W-4, let me know and I will assist in the change.

 

You will be eligible to receive 25% of your salary as an annual bonus. This bonus has been established by the Company’s Board of Directors in its sole discretion, and the Company reserves the right to modify such bonus at any time earned.

 

This letter and the corresponding Exhibit B AMENDED, along with the provisions of your original employment agreement that are not impacted by the amendment, shall constitute your entire employment contract with the Company. The provisions of your employment contract, including, but not limited to, its at-will employment provisions, may not be modified or amended except by a written agreement signed by the Chief Executive Officer of the Company and you.

 

We look forward to your favorable reply and continued success at the Company.

 

Again, congratulations on the new position.

 

  Sincerely,
 
  Lynne Pratt
  Director Human Resources

 

Agreed to and accepted:

Signature:    
Printed Name: Michael Marquez  
Date: _________________________  

 

 
 

 

Exhibit B

 

Termination by Employee

 

You may terminate your employment with the Company at any time by providing the Company with at least thirty (30) days of notice in writing. During the resignation notice period, you will be required to perform the duties set forth in this letter. Notwithstanding, upon receipt of your resignation (other than with respect to a resignation within twelve (12) months of the occurrence of a Change in Control as defined below), the Company may, in its sole and absolute discretion, terminate your employment before the date the resignation was to be effective, and the Company will, in full satisfaction of its obligations to you: (a) continue to pay your base salary in accordance with the Company’s payroll practices until the date the resignation was to be effective up to a maximum of three (3) months, subject to the terms and conditions of Exhibit A of your offer letter; (b) reimburse the outstanding expenses properly incurred by you until the date your employment ceases; and (c) pay you a pro-rated bonus in a lump sum calculated as at the date your employment ceases as soon as administratively practicable after the termination by the Company, but in no event will any such pro-rated bonus be paid after the later of: (i) the fifteenth (15th) day of the third (3rd) month after the end of the Company’s fiscal year in which such bonus is earned, or (ii) March 15 following the calendar year in which such bonus is earned.

 

Termination by Company for Cause, Death or Disability

 

The Company may terminate your employment at any time with Cause and without prior notice or any further obligations by the Company. On the termination of your employment for cause or on your death or disability, the Company will, in full satisfaction of its obligations to you: (a) pay your base salary and vacation pay accrued until the date your employment ceases; and (b) reimburse the outstanding expenses properly incurred by you until the date your employment ceases. You will not be entitled to any other payments (including severance or bonus) should you be terminated for Cause.

 

For the purposes of this Exhibit, a termination for “Cause” occurs in the event you are terminated because:

 

  (1) You breach your employment contract;
     
  (2) You commit an act of dishonesty, fraud, or misrepresentation, or other acts of moral turpitude, including acts that jeopardize the Company’s reputation or relationship with its employees, shareholders, clients, vendors or affiliates;
     
  (3) You violate your duty of loyalty to the Company;
     
  (4) You misappropriate or fail to protect the Company’s proprietary and or confidential information, or that of the Company’s clients, partners, or affiliates;
     
  (5) You are convicted of a felony;
     
  (6) You die or become disabled in a manner that prevents you from being able to perform the essential functions of your job with reasonable accommodation.

 

 
 

 

If your termination occurs due to your death or disability, you will be entitled to a pro-rated bonus calculated as at the date your employment ceases, which shall be paid in a lump sum as soon as administratively practicable after your death or disability, but in no event will any such pro-rated bonus be paid after the later of: (i) the fifteenth (15th) day of the third (3rd) month after the end of the Company’s fiscal year in which such bonus is earned, or (ii) March 15 following the calendar year in which such bonus is earned.

 

Termination by Company without Cause or Resignation on Change of Control

 

The Company may terminate your employment at any time without cause on providing written notice, and if it does terminate you without cause the Company will pay you the severance benefits outlined in subdivision (a) and (b) below. Also, you may resign due to a Material Adverse Change in your terms and conditions of employment within twelve (12) months following the occurrence of a Change in Control as defined below, on providing written notice within thirty (30) days of the events constituting a Material Adverse Change and a cure period of not less than thirty (30) days for the Company to cure any such Material Adverse Change; provided, however, that such resignation must occur within thirty (30) days following the end of such cure period. If the Company terminates your employment without cause or if you resign within twelve (12) months of a Change in Control due to a Material Adverse Change and after providing the required notice and cure period, then subject to the terms and conditions of Exhibit C, the Company will, in full satisfaction of its obligations to you:

 

(a) Pay a lump sum amount equal to: (i) one (1) times your annual base salary in effect at the time of the termination; plus (ii) one (1) times the average of the bonus paid to you in the two (2) years preceding the year of termination; and

 

(b) Reimburse you for the cost of group health benefit plan premiums for up to twelve (12) months from the date your employment ceases. Such reimbursements shall be made concurrent with any obligation owed to you by the Company under the U.S. federal COBRA law to the extent applicable. Notwithstanding the foregoing, if the Company determines in its sole discretion that it cannot provide the foregoing COBRA premium reimbursements without potentially violating, or being subject to an excise tax under, applicable law (including, without limitation, Section 2716 of the Public Health Service Act), the Company will in lieu thereof provide to you a taxable monthly payment, payable on the last day of a given month (except as provided by the following sentence), in an amount equal to the monthly COBRA premium that you would be required to pay to continue the group health coverage for you and/or your eligible dependents in effect on the termination of employment date (which amount will be based on the premium for the first month of COBRA coverage), which payments will be made regardless of whether you and/or your eligible dependents elect COBRA continuation coverage and will commence on the month following your termination of employment and will end on the earlier of (x) the date upon which you obtain other employment or (y) the date the Company has paid an amount equal to twelve (12) payments. Any such taxable monthly payments that otherwise would have been paid to you within the sixty (60) days following your termination date instead will be paid on the sixty-first (61st) day following your termination of employment, with any remaining payments paid as provided in the prior sentence (subject to any delay as may be required by Appendix C). For the avoidance of doubt, the taxable payments in lieu of COBRA reimbursements may be used for any purpose, including, but not limited to continuation coverage under COBRA, and will be subject to all applicable tax withholdings.

 

 
 

 

As set forth in Exhibit C to your employment contract, your receipt of any severance benefits under this Agreement or otherwise is expressly conditioned upon your execution of a complete and general release of all claims that may be released as a mater of law.

 

Change of Control and “Material Adverse Change”

 

“Change of Control” means:

 

(a) any transaction or series of transactions, whether by way of consolidation, amalgamation or merger of the Company, with or into any other person, other than an affiliate of the Company as defined in the Ontario Business Corporations Act as amended (an “Affiliate”);

 

(b) any transfer, conveyance, sale, lease, exchange or otherwise of all or substantially all of the assets of the Company, to any other person, other than an Affiliate;

 

(c) more than fifty percent (50%) of the directors of the Company in office (i) were not directors of the Company on the same day in the immediately preceding calendar year and (ii) were not proposed by the directors of the Company existing prior to their appointment or election;

 

(d) the lawful acquisition, directly or indirectly and by any means whatsoever, by any person, or by a group of persons acting jointly or in concert, of that number of voting shares of the Company, which is forty percent (40%) or more of the total voting shares issued and outstanding immediately after such acquisition, unless another person or group of persons has previously lawfully acquired and continues to hold a number of voting units which represents a greater percentage than the first-mentioned person or group of persons; or

 

(e) the directors of the Company by resolution deem that a Change in Control has occurred or is about to occur.

 

Consequences of Termination

 

Upon termination of your employment for any reason, the Company will pay your base salary and vacation pay accrued until the date your employment ceases and reimburse your expenses properly incurred until the date your employment ceases. The termination of your employment terminates any officer positions you may hold pursuant to this letter, and you agree to sign any documentation necessary to give effect to this Exhibit B, or to give effect to any pro forma resolutions of the Company in respect of the period prior to termination of your employment.

 

 
 

 

Exhibit C

 

To the extent any severance benefits will be made under this letter, they will be delayed as necessary pursuant to (A) the Release requirement described below and (B) the provisions of Section 409A of the U.S. Internal Revenue Code of 1986, as amended (the “Code”), and the final regulations and any guidance promulgated thereunder and any applicable state law equivalents (“Section 409A”), each as outlined below.

 

Release Requirement

 

The receipt of any severance pay and benefits under this letter is subject to you signing and not revoking a standard release of claims with the Company (the “Release”) and provided that the Release becomes effective and irrevocable within sixty (60) days following your termination of employment (such deadline, the “Release Deadline”). If the Release does not become effective and irrevocable by the Release Deadline, you will forfeit any rights to severance benefits under this letter.

 

Severance pay and benefits under this letter will commence or be paid, as applicable, on the sixtieth (60th) day following the date of your termination of employment, or, if later, such time as required by the paragraphs below. Except as required by the paragraphs below, any lump sum or installment payments that would have been made to you during the sixty (60) day period immediately following your termination of employment but for the preceding sentence will be paid on the first payroll period following the sixtieth (60th) day following your termination of employment and the remaining payments will be made as provided in this letter.

 

Section 409A

 

Notwithstanding anything to the contrary in this letter, no severance benefits to be paid or provided to you, if any, pursuant to this letter or otherwise that, when considered together with any other severance payments or separation benefits, are considered deferred compensation under Section 409A (together, the “Deferred Payments”) will be paid or otherwise provided until you have a “separation from service” within the meaning of Section 409A. Similarly, no severance payable to you, if any, pursuant to this letter that otherwise would be exempt from Section 409A pursuant to U.S. Treasury Regulation Section 1.409A-1(b)(9) will be payable until you have a “separation from service” within the meaning of Section 409A.

 

Notwithstanding anything to the contrary in this letter or otherwise, if you are a “specified employee” within the meaning of Section 409A at the time of your termination (other than due to death), then the Deferred Payments, if any, that are payable within the first six (6) months following your separation from service, will become payable on the first payroll date that occurs on or after the date six (6) months and one (1) day following the date of your separation from service. All subsequent Deferred Payments, if any, will be payable in accordance with the payment schedule applicable to each payment or benefit. Notwithstanding anything herein to the contrary, if you die following your separation from service, but prior to the six (6) month anniversary of your separation from service, then any payments delayed in accordance with this paragraph will be payable in a lump sum as soon as administratively practicable after the date of your death and all other Deferred Payments will be payable in accordance with the payment schedule applicable to each payment or benefit. Each payment, installment and benefit payable under this letter is intended to constitute a separate payment for purposes of U.S. Treasury Regulation Section 1.409A-2(b)(2).

 

 
 

 

Any amount paid under this letter that qualifies as a payment made as a result of an involuntary separation from service pursuant to U.S. Treasury Regulation Section 1.409A-1(b)(9)(iii) that does not exceed the Section 409A Limit will not constitute a Deferred Payment.

 

For purposes of this letter, “Section 409A Limit” will mean one-half (50%) of the lesser of: (i) your annualized compensation based upon the annual rate of pay paid to you during your taxable year preceding the taxable year of your separation from service as determined under U.S. Treasury Regulation Section 1.409A-1(b)(9)(iii)(A)(1) and any Internal Revenue Service guidance issued with respect thereto; or (ii) the maximum amount that may be taken into account under a qualified plan pursuant to Section 401(a)(17) of the Code for the year in which your separation from service occurs.

 

All reimbursements and in-kind benefits under this letter that provide for a “deferral of compensation” within the meaning of Section 409A (i) shall be made no later than the last day of the calendar year that immediately follows the calendar year in which Employee incurred the expense; (ii) not be subject to liquidation or exchange for another benefit or payment; (iii) provided to Employee in any calendar year shall not affect the expenses eligible for reimbursement or in-kind benefits to be provided in any other calendar year; and (iv) except as specifically provided herein, any such reimbursements or in-kind benefits must be for expenses incurred and benefits provided on or prior to termination (except that a plan providing medical or health benefits may, to the extent permitted by Section 409A impose a generally applicable limit that may be reimbursed or paid). To the extent applicable, reimbursements that provide for a “deferral of compensation” within the meaning of Section 409A are intended to constitute compliant deferred compensation payable on a specified date or fixed schedule in accordance with the requirements set forth under U.S. Treasury Regulation Section 1.409A-3(i)(1)(iv).

 

The foregoing provisions are intended to be exempt from or comply with the requirements of Section 409A so that none of the severance payments and benefits to be provided hereunder will be subject to the additional tax imposed under Section 409A, and any ambiguities or ambiguous terms herein will be interpreted to be exempt or so comply. You and the Company agree to work together in good faith to consider amendments to this letter agreement and to take such reasonable actions which are necessary, appropriate or desirable to avoid imposition of any additional tax or income recognition prior to actual payment to you under Section 409A.

 

 
 

 

EX-31.1 4 ex31-1.htm

 

Exhibit 31.1

 

CERTIFICATION PURSUANT TO RULE 13A-14 OR 15D-14 OF THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Joseph Jensen, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of TearLab Corporation;
   
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
   
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
   
4. The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
   
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under the Company’s supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
   
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under the Company’s supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
   
c) evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report the Company’s conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
   
d) disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
   
5. The Registrant’s other certifying officer and I have disclosed, based on the Company’s most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of Registrant’s board of directors (or persons performing the equivalent function):
   
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
   
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

 

Dated: May 11, 2018

 

  /s/ Joseph Jensen
  Joseph Jensen
  Chief Executive Officer

 

   
 

 

EX-31.2 5 ex31-2.htm

 

Exhibit 31.2

 

CERTIFICATION PURSUANT TO RULE 13A-14 OR 15D-14 OF THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Michael Marquez, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of TearLab Corporation;
   
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
   
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
   
4. The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
   
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under the Company’s supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
   
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under the Company’s supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
   
c) evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report the Company’s conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
   
d) disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
   
5. The Registrant’s other certifying officer and I have disclosed, based on the Company’s most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of Registrant’s board of directors (or persons performing the equivalent function):
   
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
   
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

 

Dated: May 11, 2018

 

  /s/ Michael Marquez
  Michael Marquez
  Interim Chief Financial Officer

 

   
 

 

EX-32.1 6 ex32-1.htm

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q of TearLab Corporation (the “Company”) for the quarter ended March 31, 2018, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Joseph Jensen, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

 

1. The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
   
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

  By: /s/ Joseph Jensen
    Joseph Jensen
    Chief Executive Officer

 

Dated: May 11, 2018

 

   
 

 

EX-32.2 7 ex32-2.htm

 

Exhibit 32.2

 

CERTIFICATION PURSUANT TO

18 U.S.C SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q of TearLab Corporation (the “Company”) for the quarter ended March 31, 2018, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Michael Marquez, Interim Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

 

1. The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
   
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

  By: /s/ Michael Marquez
    Michael Marquez
    Interim Chief Financial Officer

 

Dated: May 11, 2018

 

   
 

 

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XML 19 R2.htm IDEA: XBRL DOCUMENT v3.8.0.1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Current assets    
Cash $ 7,431 $ 7,272
Accounts receivable, net 1,452 1,536
Inventory 1,683 1,998
Prepaid expenses and other current assets 629 690
Total current assets 11,195 11,496
Fixed assets, net 2,460 2,739
Intangible assets, net 7 10
Other non-current assets 50 100
Total assets 13,712 14,345
Current liabilities    
Accounts payable 1,073 1,720
Accrued liabilities 2,649 2,859
Deferred rent 34 42
Current portion of long-term debt 3,630
Total current liabilities 7,386 4,621
Long-term debt, net of current portion 25,770 28,290
Total liabilities 33,156 32,911
Commitments and contingencies (Note 8)
Stockholders' deficit    
Preferred Stock, $0.001 par value, 10,000,000 authorized, 934 and 2,012 issued and outstanding at March 31, 2018 and December 31, 2017, respectively
Common stock, $0.001 par value, 40,000,000 authorized, 10,438,998 and 7,986,998 issued and outstanding at March 31, 2018 and December 31, 2017, respectively 10 8
Additional paid-in capital 510,238 510,235
Accumulated deficit (529,692) (528,809)
Total stockholders' deficit (19,444) (18,566)
Total liabilities and stockholders' deficit $ 13,712 $ 14,345
XML 20 R3.htm IDEA: XBRL DOCUMENT v3.8.0.1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
Mar. 31, 2018
Dec. 31, 2017
Statement of Financial Position [Abstract]    
Preferred stock, par value $ 0.001 $ 0.001
Preferred stock, shares authorized 10,000,000 10,000,000
Preferred stock, shares issued 934 2,012
Preferred stock, shares outstanding 934 2,012
Common stock, par value $ 0.001 $ 0.001
Common stock, shares authorized 40,000,000 40,000,000
Common stock, shares issued 10,438,998 7,986,998
Common stock, shares outstanding 10,438,998 7,986,998
XML 21 R4.htm IDEA: XBRL DOCUMENT v3.8.0.1
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Revenue    
Product sales $ 5,775 $ 5,987
Reader equipment rentals 671 714
Total revenue 6,446 6,701
Cost of goods sold    
Cost of goods sold (excluding amortization of intangible assets) 1,836 2,542
Cost of goods sold - reader equipment depreciation 288 466
Gross profit 4,322 3,693
Operating expenses    
Sales and marketing 1,020 3,332
Clinical, regulatory and research & development 1,041 1,564
General and administrative 2,044 2,187
Total operating expenses 4,105 7,083
Income (loss) from operations 217 (3,390)
Other income (expense)    
Interest income (expense) (1,105) (1,028)
Other, net 5 (3)
Total other income (expense) (1,100) (1,031)
Net loss and comprehensive loss $ (883) $ (4,421)
Weighted average shares outstanding - basic and fully diluted 9,562,122 5,367,311
Net loss per share $ (0.09) $ (0.82)
XML 22 R5.htm IDEA: XBRL DOCUMENT v3.8.0.1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
OPERATING ACTIVITIES    
Net loss for the period $ (883) $ (4,421)
Adjustments to reconcile net loss to cash used in operating activities:    
Stock-based compensation 8 289
Depreciation of fixed assets 353 521
Amortization of intangible assets 3 15
Deferred interest on long-term debt 914 302
Amortization of debt discount 193 154
Changes in operating assets and liabilities:    
Accounts receivable, net 84 13
Inventory 314 (131)
Prepaid expenses and other assets 111 10
Accounts payable (647) 889
Accrued liabilities (210) 123
Deferred rent/revenue (8) (12)
Cash provided by (used in) operating activities 232 (2,248)
INVESTING ACTIVITIES    
Additions to fixed assets (73) (223)
Cash used in investing activities (73) (223)
FINANCING ACTIVITIES    
Repurchase of fractional shares upon reverse stock split (3)
Proceeds from the issuance of employee stock purchase plan shares 35
Cash provided by financing activities 32
Increase (decrease) in cash and cash equivalents during the period 159 (2,439)
Cash, beginning of period 7,272 15,471
Cash, end of period 7,431 13,032
Supplemental cash flow information    
Cash paid for interest $ 571
XML 23 R6.htm IDEA: XBRL DOCUMENT v3.8.0.1
Basis of Presentation
3 Months Ended
Mar. 31, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Basis of Presentation

1. BASIS OF PRESENTATION

 

Nature of Operations

 

TearLab Corporation (“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 statements include the accounts of the Company and all of its wholly owned subsidiaries. Intercompany accounts and transactions have been eliminated on consolidation.

 

Liquidity and Going Concern

 

The accompanying condensed 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. The Company has sustained substantial losses of $883 and $4,421 for the three months ended March 31, 2018 and 2017, respectively. Based on the Company’s expected rate of cash consumption in the latter quarters of 2018, the Company estimates it will need additional capital in the first quarter of 2019 and its prospects for obtaining that capital are uncertain. The Company may be able to raise 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 2019 without violating an existing covenant on the Term Loan Agreement (see Note 5). 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.

XML 24 R7.htm IDEA: XBRL DOCUMENT v3.8.0.1
Significant Accounting Policies
3 Months Ended
Mar. 31, 2018
Accounting Policies [Abstract]  
Significant Accounting Policies

2. SIGNIFICANT ACCOUNTING POLICIES

 

The Condensed Consolidated Balance Sheet at December 31, 2017 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 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, 2017. The audited financial statements for the year ended December 31, 2017, filed with the SEC with the Company’s annual report on Form 10-K on March 5, 2018 include a summary of 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 normal recurring items, have been included in the unaudited condensed consolidated financial statements for the interim periods presented.

  

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

 

On January 1, 2018 the Company adopted Topic 606 – Revenue from Contracts with Customers using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under Topic 605 – Revenue Recognition.

 

There was no net reduction to opening retained earnings as a result of adopting Topic 606 and no impact to revenues for the three months ended March 31, 2018.

 

Revenue is recognized when obligations under the terms of a contract with our customer are satisfied; generally this occurs with the transfer of control of our products or services. Revenue is measured as the amount of consideration we expect to receive in exchange for transferring goods or providing services which includes estimates of variable consideration that results from returns, rebates or test card replacements. The Company records allowances for returns or rebates and reports revenue net of such amounts, which was immaterial for the three months ended March 31, 2018. Sales and other taxes we collect concurrent with revenue-producing activities are excluded from revenue. The Company’s payment terms are typically upon shipment or net 30.

 

The Company sells its proprietary TearLab® Osmolality System and related test cards to external customers, who are primarily eye care professionals, for use in osmolality 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 (referred to as either “Use Agreements”, “Masters Agreements” or “Flex Agreements”), or from agreements to sell the reader equipment and disposable test cards at their stand-alone selling price with no contractual future purchase commitment (referred to as “Purchase Agreements”).

 

Use, Masters, and Flex 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. Two performance obligations exist under these contracts, related to the customers’ right to use the reader equipment and orders of test cards. As the customer has the ability and right to operate the reader equipment in a manner it determines as well as obtain the output from using the reader equipment, the revenue related to the reader equipment use performance obligation is recognized in accordance with ASC 840 – Leases, wherein revenue related to the reader equipment is recognized over the defined contract term. Revenue related to disposable test cards is recognized as the disposable test cards are shipped. Based on the nature of these contracts, which provide terms for the future purchase of test cards but do not contractually obligate the customer to do so, each purchase of test cards is treated as its own distinct contract with a performance obligation to provide the test cards ordered, memorialized by the customers’ purchase order/request. 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 standalone selling price, which is estimated using the selling prices of the reader device and test cards under Purchase Agreements, discussed further below.

 

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 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 Consolidated Statements of Operations and Comprehensive Loss.

 

Purchase Agreements

 

Revenue recognition for Purchase Agreements is based on the individual performance obligations determined to exist in the contract. Since the reader equipment and the test cards are separate and distinct delivered items, the delivery of each are considered separate performance obligations. The reader equipment and test cards are separately identified under the Purchase Agreements and are sold at their standalone selling price. The Company recognizes revenue for each of the performance obligations only when it determines that all applicable recognition criteria have been met, which is usually upon shipment to the customer. Under Purchase Agreements, the customer is not contractually obligated to purchase additional test cards, and each subsequent order of test cards represents a separate and distinct contract with the performance obligation to provide the test cards ordered.

 

Amounts billed to customers for shipping and handling of a sales transaction are included as revenue. For the three months ended March 31, 2018 and 2017, the Company recognized revenue from shipping and handling of $39 and $44, respectively.

  

The following table presents our revenues disaggregated by revenue source. Sales and usage-based taxes are excluded from revenues:

 

    Three months ended March 31,  
    2018     2017  
             
Product Sales   $ 5,775     $ 5,987  
Reader Equipment Rentals     671       714  
    $ 6,446     $ 6,701  

 

Arrangements with Multiple Performance Obligations

 

Our contracts with customers may include multiple performance obligations. For such arrangements, we allocate revenue to each performance obligation based on its relative standalone selling price. We generally determine standalone selling prices based on the separate prices charged to customers for the reader device and test cards under Purchase Agreements.

 

Return Reserve

 

Although the Company has a no return policy for its products, the Company has established a return reserve for product sales that contain an implicit right of return. The Company reserves for estimated returns or refunds by reducing revenue at the time of shipment based on historical experience. The reserve of $7 and $9 as of March 31, 2018 and December 31, 2017, respectively, has been recorded as a reduction of revenue and is included in accounts receivable.

 

Practical Expedients and Exemptions

 

We generally expense outside sales commissions when incurred because the amortization period would have been one year or less. These costs are recorded within sales and marketing expenses.

 

We do not disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one year or less and (ii) contracts for which we recognize revenue at the amount to which we have the right to invoice for services performed.

 

Recent accounting pronouncements

 

In July 2017, the FASB issued Accounting Standards Update No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) Part I. Accounting for Certain Financial Instruments with Down Round Features Part II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”). Part I of this update addresses the complexity of accounting for certain financial instruments with down round features. Down round features are features of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of the entire instrument or conversion option. Part II of this update addresses the difficulty of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB Accounting Standards Codification. This pending content is the result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable non-controlling interests. ASU 2017-11 is effective for fiscal years and interim periods after December 31, 2018. The Company early adopted ASU 2017-11 effective December 31, 2017.

 

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.

 

On January 1, 2018, we adopted Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers, using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under Topic 605. Additionally, accounting for leased reader equipment is outside the scope of Topic 606, therefore our leased reader equipment revenue is recognized under ASC 840, Leases.

XML 25 R8.htm IDEA: XBRL DOCUMENT v3.8.0.1
Balance Sheet Details
3 Months Ended
Mar. 31, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Balance Sheet Details

3. BALANCE SHEET DETAILS

 

Accounts receivable

 

    March 31, 2018     December 31, 2017  
             
Trade receivables   $ 1,869     $ 2,044  
Allowance for doubtful accounts     (417 )     (508 )
    $ 1,452     $ 1,536  

 

Inventory

 

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

 

    March 31, 2018     December 31, 2017  
             
Finished goods   $ 1,684     $ 2,125  
Inventory reserves     (1 )     (127 )
    $ 1,683     $ 1,998  

 

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 term purchase commitment to buy the test cards from MiniFAB (Note 8). 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.

 

Prepaid expenses and other current assets

 

    March 31, 2018     December 31, 2017  
Prepaid trade shows   $ -     $ 14  
Prepaid insurance     213       313  
Manufacturing deposits     230       -  
Subscriptions     133       311  
Other fees and services     53       52  
    $ 629     $ 690  

  

Fixed assets

 

    March 31, 2018     December 31, 2017  
Capitalized TearLab equipment   $ 7,213     $ 8,437  
Leasehold improvements     60       60  
Computer equipment and software     895       915  
Furniture and office equipment     437       436  
Medical equipment     1,220       1,180  
    $ 9,825     $ 11,028  
Less accumulated depreciation     (7,365 )     (8,289 )
    $ 2,460     $ 2,739  

 

Depreciation expense was $353 and $521 during the three months ended March 31, 2018 and 2017, respectively.

 

Accrued liabilities

 

    March 31, 2018     December 31, 2017  
Due to professionals   $ 414     $ 193  
Due to employees and directors     1,018       944  
Sales and use tax liabilities     235       253  
Royalty liability     227       447  
Warranty     129       131  
Restructuring     44       200  
Other     582       691  
    $ 2,649     $ 2,859  

 

The change in royalty liability is attributable to an amended patent license and royalty agreement with the University of California San Diego with an effective date of July 1, 2017, which reduced the royalty to 3% from 5.5% (see Note 8).

XML 26 R9.htm IDEA: XBRL DOCUMENT v3.8.0.1
Intangible Assets
3 Months Ended
Mar. 31, 2018
Goodwill and Intangible Assets Disclosure [Abstract]  
Intangible Assets

4. INTANGIBLE ASSETS

 

The Company’s intangible assets consist of the value of TearLab® Technology acquired in the acquisition of TearLab Research, Inc., a wholly-owned subsidiary of the 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. Amortization expense for the three months ended March 31, 2018 and 2017 was $3 and $15, respectively.

 

Intangible assets subject to amortization consist of the following:

 

   

Remaining

Useful Life

    Gross Value at     Accumulated     Net Book Value at  
    (Years)     March 31, 2018     Amortization     March 31, 2018  
                         
TearLab® technology     0     $ 12,172     $ (12,172 )   $ -  
Patents and trademarks     1       271       (264 )     7  
Prescriber list     0       90       (90 )     -  
Total           $ 12,533     $ (12,526 )   $ 7  

 

    Gross Value at     Accumulated     Net Book Value at  
    December 31, 2017     Amortization     December 31, 2017  
                   
TearLab® technology   $ 12,172     $ (12,172 )   $ -  
Patents and trademarks     271       (261 )     10  
Prescriber list     90       (90 )     -  
Total   $ 12,533     $ (12,523 )   $ 10  

 

The estimated amortization expense for the intangible assets for the remainder of 2018 and thereafter is as follows:

 

    Amortization  
    of intangible  
    assets  
       
Remainder of 2018   $ 5  
Thereafter     2  
    $ 7  

XML 27 R10.htm IDEA: XBRL DOCUMENT v3.8.0.1
Term Loan
3 Months Ended
Mar. 31, 2018
Debt Disclosure [Abstract]  
Term Loan

5. 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 December 31, 2020 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 principle of the loan and is subject to additional accrued interest (“PIK interest”). The accrued interest can be deferred and paid together with the principle in the fifth and sixth years.

 

As part of the amended Term Loan Agreement, and funding of the second tranche, CRG received 35,000 warrants dated as of October 6, 2015 to purchase common shares of the Company at a price of $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 Sheets as of March 31, 2018 and December 31, 2017. 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. On April 7, 2017, the Company amended the Term Loan Agreement and the Company issued CRG additional warrants to purchase 35,000 common shares of the Company’s stock at $15.00 per share, which expires 5 years after issuance.

 

On April 4, 2018 with an effective date of March 31, 2018, the Company entered into an Amendment to the Term Loan Agreement. Pursuant to the terms of the Amendment, the cash interest payments due in 2018 will be deferred and added to the principal balance under the Loan Agreement at the end of each quarter. The Amendment also provides for an additional facility fee equal to 3% of the sum of the aggregate amount of the principal drawn under the Term Loan Agreement and any PIK loans issued, so that the total facility fee shall be 9.5%, applicable to the entire balance. In addition, the Amendment reduces the minimum liquidity covenant to $3 million. Concurrent with the reduction of the liquidity covenant the Company agreed to repay CRG $1.0 million of principal on the Term Loan Agreement in April 2018. Lastly, this amendment reduced the strike price of the existing CRG Warrants to $0.44 per share (see Note 6). The Amendment was accounted for as a modification in accordance with U.S. GAAP.

 

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 October 12, 2017, the Company amended the Term Loan Agreement to change the required minimum revenue levels. The amended minimum revenue is $25,000 for 2018, $38,000 for 2019 and $45,000 for 2020. The amendment also reduced the exercise price of all of the CRG Warrants from $15.00 per share to $1.50 per share as well as provide broad anti-dilution protection such that the CRG Warrants shall maintain the same 1.22% ownership following any capital raises the Company completed through March 31, 2018. The minimum cash balance required was reduced to $3,000, subject to certain conditions.

 

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 March 31, 2018, 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 9.5% of the aggregate principal amount of the loan, including 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 Consolidated Balance Sheet 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 March 31, 2018 and related maturities of outstanding principal:

 

Principal balance outstanding   $ 25,000  
PIK interest     4,038  
Facility fee     880  
less discount on term loan:        
deferred financing fees, net     (284 )
detachable warrants, net     (234 )
    $ 29,400  
Less, current portion of Term loan     3,630  
Total Term Loan   $ 25,770  

 

Principal due for each of the next 3 years:

 

2018   $ -  
2019     14,519  
2020     15,399  
Total principal due     29,918  
Less: discount on term loan     (518 )
Total term loan   $ 29,400  

XML 28 R11.htm IDEA: XBRL DOCUMENT v3.8.0.1
Stockholders' Equity
3 Months Ended
Mar. 31, 2018
Equity [Abstract]  
Stockholders' Equity

6. STOCKHOLDERS’ EQUITY

 

(a) Authorized share capital

 

On October 12, 2017, the stockholders of the Company approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 9,500,000 to 40,000,000. 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.

 

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.

 

(b) Common and preferred shares

 

On December 8, 2017, the Company issued 2,013,636 shares of common stock, 2,114 shares of Series A Convertible Preferred Stock (“Preferred Stock”), Series A warrants to purchase 6,818,181 shares of common Stock (“Series A Warrants”) and Series B warrants to purchase 6,818,181 shares of common stock (“Series B Warrants”) for gross proceeds of $3,000, less issuance costs of $596. Additionally, the Company granted the placement agent compensation warrants to purchase 477,273 shares of common stock. The Preferred Stock is convertible, subject to certain limitations, into an aggregate of 4,804,545 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. The common stock, Preferred Stock, and the Series A Warrants and Series B Warrants are all included in equity in the Company’s consolidated balance sheets as of March 31, 2018 and December 31, 2017. The net proceeds were allocated to common stock, Preferred Stock, Series A Warrants and Series B Warrants based on their relative fair values as follows:

 

Common stock   $ 327  
Preferred stock     781  
Series A warrants     804  
Series B warrants     492  
Net proceeds   $ 2,404  

 

As of March 31, 2018, 1,180 shares of Series A Preferred Stock have been converted into 2,682,909 shares of common stock.

  

(c) Stock Incentive Plan

 

On June 23, 2017, the Company’s stockholders approved an amendment to the 2002 Stock Incentive Plan (the “Stock Incentive Plan”), to increase 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. Shares granted under the Stock Incentive Plan may be either incentive stock options or non-statutory stock options. 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.

 

Share-based payment transactions with employees are recognized in the condensed consolidated 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 statements of operations and comprehensive loss (in thousands):

 

    Three months ended  
    March 31,  
    2018     2017  
             
Sales and marketing   $ 18     $ 146  
Clinical, regulatory and research and development     8       43  
General and administrative     (18 )     100  
Stock-based compensation expense before income taxes   $ 8     $ 289  

 

(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 28,601 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 purchase more than $25 worth of stock in the plan during each calendar year or purchase more than 500 shares per offering period. During the three months ended March 31, 2018 and 2017, the Company recorded $0 and $3 of expense, respectively, under the ESPP. During the three months ended March 31, 2018 and 2017, the Company issued 0 and 7,512 shares of common stock under the ESPP, respectively. In early 2018, the Company terminated the Employee Stock Purchase Plan.

 

(e) Warrants

 

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 35,000 common shares in the Company at a price of $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 March 31, 2018 and December 31, 2017. 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 three months ended March 31, 2018 or 2017.

 

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 35,000 common shares in the Company at a price of $15.00 per share and CRG was issued an additional 35,000 warrants to purchase common shares at an exercise price of $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. 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 1,253,500 shares of common stock for $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.

 

On October 12, 2017, 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 common shares in the Company at a price of $1.50 per share as well as provide broad anti-dilution protection such that the CRG Warrants shall maintain the same 1.22% ownership following any capital raises the Company completed through March 31, 2018. The modification to the terms of the CRG Warrants and 2016 CRG Warrants resulted in a change in fair value of $44 which was included as interest expense. The CRG Warrants change in fair value was calculated using the Black-Scholes Merton model with both exercise prices, assuming volatility of 94%, an expected life of 2.99 years, a risk-free interest rate of 1.70% and 0% dividend yield. The 2016 CRG Warrants change in fair value was calculated using the Black-Scholes Merton model with both exercise prices, assuming volatility of 90%, an expected life of 3.48 years, a risk-free interest rate of 1.80% and 0% dividend yield.

 

On December 8, 2017, the Company issued Series A Warrants to purchase 6,818,181 shares of common stock for $0.44 per share and Series B Warrants to purchase 6,818,181 shares of common stock for $0.44 per share in conjunction with shares of common stock and Series A Convertible Preferred stock issued on that same date. The Series A Warrants can be exercised immediately and expire 5 years after the issuance 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 88%, an expected life of 5 years, a risk free interest rate of 2.14% and a 0% dividend yield and are classified as equity on the Condensed Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017. The Series B Warrants can be exercised immediately and expire 6 months after the issuance date. Fair value of the Series B Warrants for purposes of allocating the net proceeds of the equity offering, was determined using the Black-Scholes Merton model assuming a volatility of 158.6%, an expected life of 6 months, a risk free rate of 1.45% and a 0% dividend yield and are classified as equity on the Condensed Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017. In addition, we granted the placement agent compensation warrants to purchase 477,273 shares of common stock at $0.55 per share. The compensation warrants are in the same form as Series A Warrants, excluding the exercise price, and will terminate on the five year anniversary date. The placement agent warrants are classified as equity on the Condensed Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017.

 

In connection with the offering the Company issued CRG warrants to purchase 83,240 shares of common stock at an exercise price of $1.50 (“2017 CRG Warrants”) as a result of triggering the anti-dilution clause of the debt amendment (see Footnote 5 for additional information). The anti-dilution clause is considered down-round protection, however the Company early adopted ASU 2017-11 and therefore the down-round feature is excluded from the consideration of whether the warrants are indexed to the Company’s own stock and therefore the warrants are not required to be liabilities under the guidance. The 2017 CRG Warrants are classified as equity on the Condensed Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017 and were valued at $30 upon issuance using the Black-Scholes Merton model assuming volatility of 88%, an expected life of 5 years, a risk-free interest rate of 2.14% and 0% dividend yield.

 

In March 2018, in connection with the amended Term Loan Agreement, the existing CRG warrants had a change in strike price to $0.44. The modification to the terms of the CRG Warrants resulted in a change in fair value of $10 which was included as interest expense.

XML 29 R12.htm IDEA: XBRL DOCUMENT v3.8.0.1
Net Income (Loss) Per Share
3 Months Ended
Mar. 31, 2018
Earnings Per Share [Abstract]  
Net Income (Loss) Per Share

7. NET INCOME (LOSS) PER SHARE

 

Basic earnings per share (“EPS”) excludes dilutive securities and is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding for the year. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted and the resulting additional shares are dilutive because their inclusion decreases the amount of EPS.

 

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

 

(in thousands of shares)   As of March 31,  
    2018     2017  
Stock options     629       706  
Warrants     15,520       1,324  
ESPP shares     -       3  
Convertible preferred shares     1       102  
                 
Total     16,150       2,135  

XML 30 R13.htm IDEA: XBRL DOCUMENT v3.8.0.1
Commitments and Contingencies
3 Months Ended
Mar. 31, 2018
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

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 December 31, 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.

 

On May 1, 2018 with an effective date of July 1, 2017 the Company entered into a Restated License Agreement (the “Agreement”) to its exclusive license agreement for the commercial development of the invention disclosed in UCSD Disclosure Docket No. SD2002-180 and titled “Volume Independent Tear Film Osmometer” (UCSD License Agreement #2003-03-0433), dated as of March 12, 2003, as amended by Amendment 1, dated as of June 9, 2003, Amendment 2, dated as of September 5, 2005, Amendment 3, dated as of July 7, 2006, Amendment 4, dated as of October 9, 2006, and Amendment 5, dated as of July 9, 2007, by and among the Company and The Regents of the University of California (collectively the “Existing License”) to amend certain terms related to royalties under the Agreement and treatment upon a change of control transaction. The Company is required to make royalty payments of anywhere from 3% to 4.25% based on quarterly net sales. Additionally, the Company is required to pay a royalty of 20% of any sublicense fees it receives. Should a change of control transaction occur during the term of the agreement the royalty rates would range anywhere from 3.5% to 4.75% based on quarterly net sales and the Company would have to make a milestone payment of $0.5 million. In addition, if the Company has not commenced commercial sales of the TearLab DiscoveryTM Platform on or before July 1, 2019 the Company will be required to pay a milestone payment of 1.25% of cumulative net sales for the two year period following the effective date of the amendment.

 

Effective October 1, 2006 the Company entered into a second 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.

 

Future minimum royalty payments under this agreement as of March 31, 2018 are as follows:

 

2018   $ 35  
2019     35  
2020     35  
2021     35  
2022     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, for the purchase and delivery of individual osmolarity test cards with the freight costs borne by MiniFab. The Company has the benefit of a lower purchase price that will remain in place until the earlier of, the Company reaches an annual volume of 4.5 million test cards or March 31, 2018. Certain savings from freight costs will remain in place throughout the agreement. The Supply Agreement requires, 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 August 2011 agreement between MiniFAB and the Company.

 

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.

 

Contingencies

 

We are not currently a party to any litigation, nor are we aware of any pending or threatened litigation against us, that we believe would materially affect our business, operating results, financial condition or cash flows. Our industry is characterized by frequent claims and litigation including securities litigation, claims regarding patent and other intellectual property rights and claims for product liability. As a result, in the future, we may be involved in various legal proceedings from time to time.

 

We initiated a patent infringement lawsuit against i-Med Pharma, Inc. in February 2016 alleging infringement of our Canadian patent. In February 2018, the Federal Court of Canada issued a ruling in favor of i-Med Pharma, Inc. which invalidated specific claims in our Canadian patent which were alleged to be infringed. We are appealing this ruling to the Canadian Federal Appellate Court. As part of the ruling, the Federal Court ruling awarded costs to i-Med Pharma, Inc., for $0.5 million. The final $0.2 million was paid in April 2018. We do not believe the outcome of this litigation will materially affect our business, operating results, financial condition or cash flows.

XML 31 R14.htm IDEA: XBRL DOCUMENT v3.8.0.1
Restructuring Costs
3 Months Ended
Mar. 31, 2018
Restructuring and Related Activities [Abstract]  
Restructuring Costs

9. RESTRUCTURING COSTS

 

On December 15, 2017 the Company approved a new business model to maintain its current customer and annuity revenue base, focus resources on the development and generation of clinical data for our next generation TearLab DiscoveryTM Platform and reduce the Company’s cash burn rate. In connection with the restructuring the Company recorded restructuring expenses of $322 primarily related to employee cost and one-time contract termination costs at December 31, 2017. Liabilities related to the restructuring are included in accrued liabilities in the Condensed Consolidated Balance Sheet. The following table summarizes the activity related to the restructuring during the three months ended March 31, 2018:

 

    Employee Costs     Other Costs     Total  
Accrued obligations as of December 31, 2017   $ 97     $ 103     $ 200  
Settlement of obligations     (75 )     (59 )     (134 )
Accrued obligations as of March 31, 2018   $ 22     $ 44     $ 66  

XML 32 R15.htm IDEA: XBRL DOCUMENT v3.8.0.1
Significant Accounting Policies (Policies)
3 Months Ended
Mar. 31, 2018
Accounting Policies [Abstract]  
Use of Estimates

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 recognition

 

On January 1, 2018 the Company adopted Topic 606 – Revenue from Contracts with Customers using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under Topic 605 – Revenue Recognition.

 

There was no net reduction to opening retained earnings as a result of adopting Topic 606 and no impact to revenues for the three months ended March 31, 2018.

 

Revenue is recognized when obligations under the terms of a contract with our customer are satisfied; generally this occurs with the transfer of control of our products or services. Revenue is measured as the amount of consideration we expect to receive in exchange for transferring goods or providing services which includes estimates of variable consideration that results from returns, rebates or test card replacements. The Company records allowances for returns or rebates and reports revenue net of such amounts, which was immaterial for the three months ended March 31, 2018. Sales and other taxes we collect concurrent with revenue-producing activities are excluded from revenue. The Company’s payment terms are typically upon shipment or net 30.

 

The Company sells its proprietary TearLab® Osmolality System and related test cards to external customers, who are primarily eye care professionals, for use in osmolality 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 (referred to as either “Use Agreements”, “Masters Agreements” or “Flex Agreements”), or from agreements to sell the reader equipment and disposable test cards at their stand-alone selling price with no contractual future purchase commitment (referred to as “Purchase Agreements”).

Use, Masters, and Flex Agreements

Use, Masters, and Flex 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. Two performance obligations exist under these contracts, related to the customers’ right to use the reader equipment and orders of test cards. As the customer has the ability and right to operate the reader equipment in a manner it determines as well as obtain the output from using the reader equipment, the revenue related to the reader equipment use performance obligation is recognized in accordance with ASC 840 – Leases, wherein revenue related to the reader equipment is recognized over the defined contract term. Revenue related to disposable test cards is recognized as the disposable test cards are shipped. Based on the nature of these contracts, which provide terms for the future purchase of test cards but do not contractually obligate the customer to do so, each purchase of test cards is treated as its own distinct contract with a performance obligation to provide the test cards ordered, memorialized by the customers’ purchase order/request. 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 standalone selling price, which is estimated using the selling prices of the reader device and test cards under Purchase Agreements, discussed further below.

 

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 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 Consolidated Statements of Operations and Comprehensive Loss.

Purchase Agreements

Purchase Agreements

 

Revenue recognition for Purchase Agreements is based on the individual performance obligations determined to exist in the contract. Since the reader equipment and the test cards are separate and distinct delivered items, the delivery of each are considered separate performance obligations. The reader equipment and test cards are separately identified under the Purchase Agreements and are sold at their standalone selling price. The Company recognizes revenue for each of the performance obligations only when it determines that all applicable recognition criteria have been met, which is usually upon shipment to the customer. Under Purchase Agreements, the customer is not contractually obligated to purchase additional test cards, and each subsequent order of test cards represents a separate and distinct contract with the performance obligation to provide the test cards ordered.

 

Amounts billed to customers for shipping and handling of a sales transaction are included as revenue. For the three months ended March 31, 2018 and 2017, the Company recognized revenue from shipping and handling of $39 and $44, respectively.

  

The following table presents our revenues disaggregated by revenue source. Sales and usage-based taxes are excluded from revenues:

 

    Three months ended March 31,  
    2018     2017  
             
Product Sales   $ 5,775     $ 5,987  
Reader Equipment Rentals     671       714  
    $ 6,446     $ 6,701  

Arrangements with Multiple Performance Obligations

Arrangements with Multiple Performance Obligations

 

Our contracts with customers may include multiple performance obligations. For such arrangements, we allocate revenue to each performance obligation based on its relative standalone selling price. We generally determine standalone selling prices based on the separate prices charged to customers for the reader device and test cards under Purchase Agreements.

Return Reserve

Return Reserve

 

Although the Company has a no return policy for its products, the Company has established a return reserve for product sales that contain an implicit right of return. The Company reserves for estimated returns or refunds by reducing revenue at the time of shipment based on historical experience. The reserve of $7 and $9 as of March 31, 2018 and December 31, 2017, respectively, has been recorded as a reduction of revenue and is included in accounts receivable.

Practical Expedients and Exemptions

Practical Expedients and Exemptions

 

We generally expense outside sales commissions when incurred because the amortization period would have been one year or less. These costs are recorded within sales and marketing expenses.

 

We do not disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one year or less and (ii) contracts for which we recognize revenue at the amount to which we have the right to invoice for services performed.

Recent Accounting Pronouncements

Recent accounting pronouncements

 

In July 2017, the FASB issued Accounting Standards Update No. 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) Part I. Accounting for Certain Financial Instruments with Down Round Features Part II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”). Part I of this update addresses the complexity of accounting for certain financial instruments with down round features. Down round features are features of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of the entire instrument or conversion option. Part II of this update addresses the difficulty of navigating Topic 480, Distinguishing Liabilities from Equity, because of the existence of extensive pending content in the FASB Accounting Standards Codification. This pending content is the result of the indefinite deferral of accounting requirements about mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable non-controlling interests. ASU 2017-11 is effective for fiscal years and interim periods after December 31, 2018. The Company early adopted ASU 2017-11 effective December 31, 2017.

 

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.

 

On January 1, 2018, we adopted Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers, using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under Topic 605. Additionally, accounting for leased reader equipment is outside the scope of Topic 606, therefore our leased reader equipment revenue is recognized under ASC 840, Leases.

XML 33 R16.htm IDEA: XBRL DOCUMENT v3.8.0.1
Significant Accounting Policies (Tables)
3 Months Ended
Mar. 31, 2018
Accounting Policies [Abstract]  
Schedule of Disaggregated Revenues

The following table presents our revenues disaggregated by revenue source. Sales and usage-based taxes are excluded from revenues:

 

    Three months ended March 31,  
    2018     2017  
             
Product Sales   $ 5,775     $ 5,987  
Reader Equipment Rentals     671       714  
    $ 6,446     $ 6,701  

XML 34 R17.htm IDEA: XBRL DOCUMENT v3.8.0.1
Balance Sheet Details (Tables)
3 Months Ended
Mar. 31, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Schedule of Accounts Receivable

Accounts receivable

 

    March 31, 2018     December 31, 2017  
             
Trade receivables   $ 1,869     $ 2,044  
Allowance for doubtful accounts     (417 )     (508 )
    $ 1,452     $ 1,536  

Schedule of Inventory

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

 

    March 31, 2018     December 31, 2017  
             
Finished goods   $ 1,684     $ 2,125  
Inventory reserves     (1 )     (127 )
    $ 1,683     $ 1,998  

Summary of Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets

 

    March 31, 2018     December 31, 2017  
Prepaid trade shows   $ -     $ 14  
Prepaid insurance     213       313  
Manufacturing deposits     230       -  
Subscriptions     133       311  
Other fees and services     53       52  
    $ 629     $ 690  

Schedule of Fixed Assets

Fixed assets

 

    March 31, 2018     December 31, 2017  
Capitalized TearLab equipment   $ 7,213     $ 8,437  
Leasehold improvements     60       60  
Computer equipment and software     895       915  
Furniture and office equipment     437       436  
Medical equipment     1,220       1,180  
    $ 9,825     $ 11,028  
Less accumulated depreciation     (7,365 )     (8,289 )
    $ 2,460     $ 2,739  

Schedule of Accrued Liabilities

Accrued liabilities

 

    March 31, 2018     December 31, 2017  
Due to professionals   $ 414     $ 193  
Due to employees and directors     1,018       944  
Sales and use tax liabilities     235       253  
Royalty liability     227       447  
Warranty     129       131  
Restructuring     44       200  
Other     582       691  
    $ 2,649     $ 2,859  

XML 35 R18.htm IDEA: XBRL DOCUMENT v3.8.0.1
Intangible Assets (Tables)
3 Months Ended
Mar. 31, 2018
Goodwill and Intangible Assets Disclosure [Abstract]  
Schedule of Amortization of Intangible Assets

Intangible assets subject to amortization consist of the following:

 

   

Remaining

Useful Life

    Gross Value at     Accumulated     Net Book Value at  
    (Years)     March 31, 2018     Amortization     March 31, 2018  
                         
TearLab® technology     0     $ 12,172     $ (12,172 )   $ -  
Patents and trademarks     1       271       (264 )     7  
Prescriber list     0       90       (90 )     -  
Total           $ 12,533     $ (12,526 )   $ 7  

 

    Gross Value at     Accumulated     Net Book Value at  
    December 31, 2017     Amortization     December 31, 2017  
                   
TearLab® technology   $ 12,172     $ (12,172 )   $ -  
Patents and trademarks     271       (261 )     10  
Prescriber list     90       (90 )     -  
Total   $ 12,533     $ (12,523 )   $ 10  

Schedule of Estimated Amortization Expense of Intangible Assets

The estimated amortization expense for the intangible assets for the remainder of 2018 and thereafter is as follows:

 

    Amortization  
    of intangible  
    assets  
       
Remainder of 2018   $ 5  
Thereafter     2  
    $ 7  

XML 36 R19.htm IDEA: XBRL DOCUMENT v3.8.0.1
Term Loan (Tables)
3 Months Ended
Mar. 31, 2018
Debt Disclosure [Abstract]  
Schedule of Term Loan

The following is a summary of the Term Loan Agreement as of March 31, 2018 and related maturities of outstanding principal:

 

Principal balance outstanding   $ 25,000  
PIK interest     4,038  
Facility fee     880  
less discount on term loan:        
deferred financing fees, net     (284 )
detachable warrants, net     (234 )
    $ 29,400  
Less, current portion of Term loan     3,630  
Total Term Loan   $ 25,770  

Schedule of Maturities of Outstanding Principal of Term Loan

Principal due for each of the next 3 years:

 

2018   $ -  
2019     14,519  
2020     15,399  
Total principal due     29,918  
Less: discount on term loan     (518 )
Total term loan   $ 29,400  

XML 37 R20.htm IDEA: XBRL DOCUMENT v3.8.0.1
Stockholders' Equity (Tables)
3 Months Ended
Mar. 31, 2018
Equity [Abstract]  
Schedule of Common and Preferred Shares

The net proceeds were allocated to common stock, Preferred Stock, Series A Warrants and Series B Warrants based on their relative fair values as follows:

 

Common stock   $ 327  
Preferred stock     781  
Series A warrants     804  
Series B warrants     492  
Net proceeds   $ 2,404  

Schedule of Stock-Based Compensation Expense

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 statements of operations and comprehensive loss (in thousands):

 

    Three months ended  
    March 31,  
    2018     2017  
             
Sales and marketing   $ 18     $ 146  
Clinical, regulatory and research and development     8       43  
General and administrative     (18 )     100  
Stock-based compensation expense before income taxes   $ 8     $ 289  

XML 38 R21.htm IDEA: XBRL DOCUMENT v3.8.0.1
Net Income (Loss) Per Share (Tables)
3 Months Ended
Mar. 31, 2018
Earnings Per Share [Abstract]  
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share

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

 

(in thousands of shares)   As of March 31,  
    2018     2017  
Stock options     629       706  
Warrants     15,520       1,324  
ESPP shares     -       3  
Convertible preferred shares     1       102  
                 
Total     16,150       2,135  

XML 39 R22.htm IDEA: XBRL DOCUMENT v3.8.0.1
Commitments and Contingencies (Tables)
3 Months Ended
Mar. 31, 2018
Commitments and Contingencies Disclosure [Abstract]  
Schedule of Future Minimum Payments

Future minimum royalty payments under this agreement as of March 31, 2018 are as follows:

 

2018   $ 35  
2019     35  
2020     35  
2021     35  
2022     35  
Thereafter     210  
Total   $ 385  

XML 40 R23.htm IDEA: XBRL DOCUMENT v3.8.0.1
Restructuring Costs (Tables)
3 Months Ended
Mar. 31, 2018
Restructuring and Related Activities [Abstract]  
Schedule of Expenses Related to Restructuring

The following table summarizes the activity related to the restructuring during the three months ended March 31, 2018:

 

    Employee Costs     Other Costs     Total  
Accrued obligations as of December 31, 2017   $ 97     $ 103     $ 200  
Settlement of obligations     (75 )     (59 )     (134 )
Accrued obligations as of March 31, 2018   $ 22     $ 44     $ 66  

XML 41 R24.htm IDEA: XBRL DOCUMENT v3.8.0.1
Basis of Presentation (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Net income (loss) $ 883 $ 4,421
XML 42 R25.htm IDEA: XBRL DOCUMENT v3.8.0.1
Significant Accounting Policies (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended 12 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Dec. 31, 2017
Accounting Policies [Abstract]      
Shipping and handling fee $ 39 $ 44  
Reserve of product sales $ 7   $ 9
XML 43 R26.htm IDEA: XBRL DOCUMENT v3.8.0.1
Significant Accounting Policies - Schedule of Disaggregated Revenues (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Accounting Policies [Abstract]    
Product sales $ 5,775 $ 5,987
Reader equipment rentals 671 714
Total revenue $ 6,446 $ 6,701
XML 44 R27.htm IDEA: XBRL DOCUMENT v3.8.0.1
Balance Sheet Details (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Depreciation expense $ 353 $ 521
Maximum [Member]    
Royalty percentage 5.50%  
Minimum [Member]    
Royalty percentage 3.00%  
XML 45 R28.htm IDEA: XBRL DOCUMENT v3.8.0.1
Balance Sheet Details - Schedule of Accounts Receivable (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Trade receivables $ 1,869 $ 2,044
Allowance for doubtful accounts (417) (508)
Accounts receivable net $ 1,452 $ 1,536
XML 46 R29.htm IDEA: XBRL DOCUMENT v3.8.0.1
Balance Sheet Details - Schedule of Inventory (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Finished goods $ 1,684 $ 2,125
Inventory reserves (1) (127)
Inventory net $ 1,683 $ 1,998
XML 47 R30.htm IDEA: XBRL DOCUMENT v3.8.0.1
Balance Sheet Details - Summary of Prepaid Expenses and Other Current Assets (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Prepaid trade shows $ 14
Prepaid insurance 213 313
Manufacturing deposits 230
Subscriptions 133 311
Other fees and services 53 52
Prepaid expense and other current assets $ 629 $ 690
XML 48 R31.htm IDEA: XBRL DOCUMENT v3.8.0.1
Balance Sheet Details - Schedule of Fixed Assets (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Property plant and equipment, gross $ 9,825 $ 11,028
Less accumulated depreciation (7,365) (8,289)
Property plant and equipment net 2,460 2,739
Capitalized TearLab Equipment [Member]    
Property plant and equipment, gross 7,213 8,437
Leasehold Improvements [Member]    
Property plant and equipment, gross 60 60
Computer Equipment and Software [Member]    
Property plant and equipment, gross 895 915
Furniture and Office Equipment [Member]    
Property plant and equipment, gross 437 436
Medical Equipment [Member]    
Property plant and equipment, gross $ 1,220 $ 1,180
XML 49 R32.htm IDEA: XBRL DOCUMENT v3.8.0.1
Balance Sheet Details - Schedule of Accrued Liabilities (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Due to professionals $ 414 $ 193
Due to employees and directors 1,018 944
Sales and use tax liabilities 235 253
Royalty liability 227 447
Warranty 129 131
Restructuring 44 200
Other 582 691
Accrued liabilities current $ 2,649 $ 2,859
XML 50 R33.htm IDEA: XBRL DOCUMENT v3.8.0.1
Intangible Assets (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Goodwill and Intangible Assets Disclosure [Abstract]    
Amortization expense $ 3 $ 15
XML 51 R34.htm IDEA: XBRL DOCUMENT v3.8.0.1
Intangible Assets - Schedule of Amortization of Intangible Assets (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Dec. 31, 2017
Gross Value $ 12,533 $ 12,533
Accumulated Amortization (12,526) (12,523)
Net Book Value $ 7 10
TearLab® Technology [Member]    
Useful Life (Years) 0 years  
Gross Value $ 12,172 12,172
Accumulated Amortization (12,172) (12,172)
Net Book Value
Patents and Trademarks [Member]    
Useful Life (Years) 1 year  
Gross Value $ 271 271
Accumulated Amortization (264) (261)
Net Book Value $ 7 10
Prescriber List [Member]    
Useful Life (Years) 0 years  
Gross Value $ 90 90
Accumulated Amortization (90) (90)
Net Book Value
XML 52 R35.htm IDEA: XBRL DOCUMENT v3.8.0.1
Intangible Assets - Schedule of Estimated Amortization Expense of Intangible Assets (Details) - Indefinite-lived Intangible Assets [Member]
$ in Thousands
Mar. 31, 2018
USD ($)
Remainder of 2018 $ 5
Thereafter 2
Total $ 7
XML 53 R36.htm IDEA: XBRL DOCUMENT v3.8.0.1
Term Loan (Details Narrative) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended
Apr. 07, 2017
Oct. 06, 2015
Mar. 04, 2015
Mar. 31, 2018
Dec. 31, 2017
Oct. 12, 2017
Apr. 08, 2016
Mar. 31, 2016
Oct. 08, 2015
Long-term debt       $ 25,770 $ 28,290        
Warrants exercise price       $ 0.44          
Financing and legal fees to long-term debt       $ (880)          
CRG Warrants [Member]                  
Warrants to purchase common shares             35,000   35,000
Warrants exercise price             $ 15.00   $ 50.00
Term Loan Agreement [Member] | CRG LP Additional Warrants [Member]                  
Warrants to purchase common shares 35,000           35,000    
Warrants exercise price $ 15.00         $ 1.50 $ 15.00    
Warrants term 5 years                
Ownership percentage           1.22%      
Term Loan Agreement [Member] | CRG LP Additional Warrants [Member] | Maximum [Member]                  
Warrants exercise price       $ 15.00          
Term Loan Agreement [Member] | CRG LP Additional Warrants [Member] | Minimum [Member]                  
Warrants exercise price       $ 1.50          
CRG LP [Member] | Term Loan Agreement [Member]                  
Minimum liquidity covenant amount       $ 3,000          
CRG LP [Member] | April 4, 2018 [Member] | Term Loan Agreement [Member]                  
Facility fee percentage on principal       3.00%          
CRG LP [Member] | CRG Warrants [Member] | Term Loan Agreement [Member]                  
Warrants exercise price       $ 0.44          
Term Loan Agreement [Member]                  
Facility fee percentage on principal       9.50%          
Term Loan Agreement [Member] | CRG LP [Member]                  
Long-term debt     $ 35,000            
Proceeds from issuance of long-term debt     $ 15,000            
Debt instrument date     Dec. 31, 2020            
Debt instrument interest rate percentage     13.00%            
Warrants to purchase common shares   35,000              
Warrants exercise price   $ 50.00              
Warrants term       5 years          
Facility fee percentage on principal       9.50%          
Payment of liquidity covenant       $ 1,000          
Financing and legal fees to long-term debt       606          
Percentage of prepayment fee               5.00%  
Percentage of reduction in annual prepayment fee               1.00%  
Term Loan Agreement [Member] | CRG LP [Member] | 2018 [Member]                  
Term loan minimum annual revenue threshold       25,000          
Term Loan Agreement [Member] | CRG LP [Member] | 2019 [Member]                  
Term loan minimum annual revenue threshold       38,000          
Term Loan Agreement [Member] | CRG LP [Member] | 2020 [Member]                  
Term loan minimum annual revenue threshold       $ 45,000          
Term Loan Agreement [Member] | CRG LP [Member] | Warrant [Member]                  
Ownership percentage       1.22%          
Minimum cash balance       $ 3,000          
Term Loan Agreement [Member] | CRG LP [Member] | Interest-Only Payment [Member]                  
Debt instrument interest rate percentage     8.50%            
Term Loan Agreement [Member] | CRG LP [Member] | Unpaid Interest With Principal [Member]                  
Debt instrument interest rate percentage     4.50%            
Term Loan Agreement [Member] | CRG LP [Member] | Second Tranche [Member]                  
Proceeds from issuance of long-term debt   $ 10,000              
XML 54 R37.htm IDEA: XBRL DOCUMENT v3.8.0.1
Term Loan - Schedule of Term Loan (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Debt Disclosure [Abstract]    
Principal balance outstanding $ 25,000  
PIK interest 4,038  
Facility fee 880  
Deferred financing fees, net (284)  
Detachable warrants, net (234)  
Total 29,400  
Less, current portion of Term loan 3,630
Total Term Loan $ 25,770 $ 28,290
XML 55 R38.htm IDEA: XBRL DOCUMENT v3.8.0.1
Term Loan - Schedule of Maturities of Outstanding Principal of Term Loan (Details)
$ in Thousands
Mar. 31, 2018
USD ($)
Debt Disclosure [Abstract]  
2018
2019 14,519
2020 15,399
Total principal due 29,918
Less: discount on term loan (518)
Total term loan $ 29,400
XML 56 R39.htm IDEA: XBRL DOCUMENT v3.8.0.1
Stockholders' Equity (Details Narrative) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 12 Months Ended
Dec. 08, 2017
Oct. 12, 2017
Jun. 23, 2017
May 09, 2016
Apr. 08, 2016
Oct. 08, 2015
Mar. 31, 2018
Mar. 31, 2017
Dec. 31, 2017
Apr. 07, 2017
Common stock shares authorized             40,000,000   40,000,000  
Common stock par value   $ 0.001         $ 0.001   $ 0.001  
Preferred stock shares authorized   10,000,000         10,000,000   10,000,000  
Preferred stock par value   $ 0.001         $ 0.001   $ 0.001  
Stock issued during period, shares new issue 2,013,636                  
Preferred stock, issued             934   2,012  
Proceeds from issuance or sale of equity             $ 2,404      
Allocated share-based compensation expense             $ 8 $ 289    
Class of warrant or right exercise price of warrants or rights             $ 0.44      
Fair value of warrants             $ 10      
Term Loan Agreement [Member] | Tranche One [Member]                    
Proceeds from issuance of long-term debt           $ 10,000        
2002 Stock Incentive Plan [Member]                    
Share-based compensation expiration period             10 years      
Expected weighted-average period             5 years      
2002 Stock Incentive Plan [Member] | Employees, Directors and Consultants [Member]                    
Share-based compensation number of shares reserved for issuance     720,000              
Employee Stock Purchase Plan 2014 [Member]                    
Share-based compensation common stock purchase price percentage             90.00%      
Common stock capital shares reserved for future issuance             28,601      
Employee stock purchase plan offering period             6 months      
Share-based compensation employee stock purchase plan contribution percentage             20.00%      
Share-based compensation employee stock purchase plan contribution maximum amount             $ 25      
Share-based compensation employee stock purchase plan contribution maximum number of shares             500      
Allocated share-based compensation expense             $ 0 $ 3    
Stock issued during period number of shares of employee stock purchase plans             0 7,512    
Series A Convertible Preferred Stock [Member]                    
Stock issued during period, shares new issue             1,180      
Preferred stock, issued 2,114                  
Common stock, conversion basis             2,682,909      
Series A Warrants [Member]                    
Preferred stock, issued 6,818,181                  
Series A Warrants [Member] | Black-Scholes Merton Model [Member]                    
Class of warrant or right number of securities called by warrants or rights 6,818,181     1,253,500            
Class of warrant or right exercise price of warrants or rights $ 0.44     $ 11.25            
Fair value assumptions expected volatility rate 88.00%     76.00%            
Fair value assumptions expected term 5 years     6 years            
Fair value assumptions risk free interest rate 2.14%     1.30%            
Fair value assumptions dividend yield 0.00%     0.00%            
Warrant expiration date, description expire 5 years after the issuance date     Expire 5 years after the Initial Exercise Date            
Series B Warrants [Member]                    
Preferred stock, issued 6,818,181                  
Proceeds from issuance or sale of equity $ 3,000                  
Payments of stock issuance costs $ 596                  
Series B Warrants [Member] | Black-Scholes Merton Model [Member]                    
Class of warrant or right number of securities called by warrants or rights 6,818,181                  
Class of warrant or right exercise price of warrants or rights $ 0.44                  
Fair value assumptions expected volatility rate 158.60%                  
Fair value assumptions expected term 6 months                  
Fair value assumptions risk free interest rate 1.45%                  
Fair value assumptions dividend yield 0.00%                  
Warrant expiration date, description expire 6 months after the issuance date                  
Placement Agent Warrants [Member]                    
Preferred stock, issued 477,273                  
Common Stock [Member]                    
Common stock, conversion basis 4,804,545                  
CRG Warrants [Member]                    
Class of warrant or right number of securities called by warrants or rights         35,000 35,000        
Class of warrant or right exercise price of warrants or rights         $ 15.00 $ 50.00        
Warrants exercisable date           Oct. 08, 2020        
Fair value of warrants           $ 290        
Fair value assumptions expected volatility rate           73.00%        
Fair value assumptions expected term           5 years        
Fair value assumptions risk free interest rate           1.71%        
Fair value assumptions dividend yield           0.00%        
CRG Warrants [Member] | Black-Scholes Merton Model [Member]                    
Class of warrant or right number of securities called by warrants or rights             83,240      
Class of warrant or right exercise price of warrants or rights             $ 1.50      
Fair value of warrants             $ 30   $ 30  
Fair value assumptions expected volatility rate             88.00%   88.00%  
Fair value assumptions expected term             5 years   5 years  
Fair value assumptions risk free interest rate             2.14%   2.14%  
Fair value assumptions dividend yield             0.00%   0.00%  
CRG Warrants [Member] | Black-Scholes Merton Model [Member] | Term Loan Agreement [Member]                    
Fair value of warrants         $ 106          
Fair value assumptions expected volatility rate   90.00%     76.00%          
Fair value assumptions expected term   3 years 5 months 23 days     5 years          
Fair value assumptions risk free interest rate   1.80%     1.30%          
Fair value assumptions dividend yield   0.00%     0.00%          
CRG LP Additional Warrants [Member] | Term Loan Agreement [Member]                    
Class of warrant or right number of securities called by warrants or rights         35,000         35,000
Class of warrant or right exercise price of warrants or rights   $ 1.50     $ 15.00         $ 15.00
Fair value of warrants   $ 44                
Ownership percentage   1.22%                
CRG LP Additional Warrants [Member] | Black-Scholes Merton Model [Member] | Term Loan Agreement [Member]                    
Fair value of warrants         $ 54          
Fair value assumptions expected volatility rate   94.00%     76.00%          
Fair value assumptions expected term   2 years 11 months 26 days     4 years 6 months          
Fair value assumptions risk free interest rate   1.70%     1.06%          
Fair value assumptions dividend yield   0.00%     0.00%          
Warrants [Member] | Black-Scholes Merton Model [Member]                    
Class of warrant or right number of securities called by warrants or rights             477,273      
Class of warrant or right exercise price of warrants or rights             $ 0.55      
Fair value assumptions expected term             5 years      
Minimum [Member]                    
Common stock shares authorized   9,500,000                
Minimum [Member] | 2002 Stock Incentive Plan [Member]                    
Share-based compensation common stock purchase price percentage     10.00%              
Minimum [Member] | CRG LP Additional Warrants [Member] | Term Loan Agreement [Member]                    
Class of warrant or right exercise price of warrants or rights             $ 1.50      
Maximum [Member]                    
Common stock shares authorized   40,000,000                
Maximum [Member] | 2002 Stock Incentive Plan [Member]                    
Share-based compensation common stock purchase price percentage     110.00%              
Maximum [Member] | 2002 Stock Incentive Plan [Member] | Officer Director Or Consultant [Member]                    
Percentage of options exercisable at a rate             20.00%      
Maximum [Member] | 2002 Stock Incentive Plan [Member] | Non-Statutory Stock Options [Member]                    
Share-based compensation common stock purchase price percentage     85.00%              
Maximum [Member] | 2002 Stock Incentive Plan [Member] | Employees, Directors and Consultants [Member]                    
Share-based compensation number of shares reserved for issuance     1,070,000              
Maximum [Member] | CRG LP Additional Warrants [Member] | Term Loan Agreement [Member]                    
Class of warrant or right exercise price of warrants or rights             $ 15.00      
XML 57 R40.htm IDEA: XBRL DOCUMENT v3.8.0.1
Stockholders' Equity - Schedule of Common and Preferred Shares (Details)
$ in Thousands
3 Months Ended
Mar. 31, 2018
USD ($)
Proceeds from issuance or sale of equity $ 2,404
Common Stock [Member]  
Proceeds from issuance or sale of equity 327
Preferred Stock [Member]  
Proceeds from issuance or sale of equity 781
Series A Warrants [Member]  
Proceeds from issuance or sale of equity 804
Series B Warrants [Member]  
Proceeds from issuance or sale of equity $ 492
XML 58 R41.htm IDEA: XBRL DOCUMENT v3.8.0.1
Stockholders' Equity - Schedule of Stock-Based Compensation Expense (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Stock-based compensation expense before income taxes $ 8 $ 289
Sales and Marketing [Member]    
Stock-based compensation expense before income taxes 18 146
Clinical, Regulatory and Research and Development [Member]    
Stock-based compensation expense before income taxes 8 43
General and Administrative [Member]    
Stock-based compensation expense before income taxes $ (18) $ 100
XML 59 R42.htm IDEA: XBRL DOCUMENT v3.8.0.1
Net Income (Loss) Per Share - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Antidilutive securities number of shares 16,150,000 2,135,000
Stock Options [Member]    
Antidilutive securities number of shares 629,000 706,000
Warrant [Member]    
Antidilutive securities number of shares 15,520,000 1,324,000
ESPP Shares [Member]    
Antidilutive securities number of shares 3,000
Convertible Preferred Shares [Member]    
Antidilutive securities number of shares 1,000 102,000
XML 60 R43.htm IDEA: XBRL DOCUMENT v3.8.0.1
Commitments and Contingencies (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended
Mar. 07, 2016
Oct. 02, 2006
Mar. 31, 2018
Royalty payment, percentage   5.50%  
Royalty payments   $ 35  
Maximum royalty payable on sale of combined products   5.50%  
i-Med Pharma, Inc. [Member]      
Loss contingency damages paid     $ 500
i-Med Pharma, Inc. [Member] | April 2018 [Member]      
Loss contingency damages paid     200
Restated License Agreement [Member]      
Revenue milestone payments     $ 500
Revenue milestone payment percentage     1.25%
Restated License Agreement [Member] | Minimum [Member]      
Royalty payment, percentage     3.50%
Restated License Agreement [Member] | Maximum [Member]      
Royalty payment, percentage     4.75%
Supply Agreement [Member] | MiniFAB [Member]      
Purchase commitment remaining minimum amount committed annual volume annual volume of 4.5 million test cards or March 31, 2018    
Minimum percentage of purchase 50.00%    
May 1, 2018 [Member] | Restated License Agreement [Member]      
Royalty payment, percentage     20.00%
May 1, 2018 [Member] | Restated License Agreement [Member] | Minimum [Member]      
Royalty payment, percentage     3.00%
May 1, 2018 [Member] | Restated License Agreement [Member] | Maximum [Member]      
Royalty payment, percentage     4.25%
XML 61 R44.htm IDEA: XBRL DOCUMENT v3.8.0.1
Commitments and Contingencies - Schedule of Future Minimum Payments (Details)
$ in Thousands
Mar. 31, 2018
USD ($)
Commitments and Contingencies Disclosure [Abstract]  
2018 $ 35
2019 35
2020 35
2021 35
2022 35
Thereafter 210
Total $ 385
XML 62 R45.htm IDEA: XBRL DOCUMENT v3.8.0.1
Restructuring Costs (Details Narrative)
$ in Thousands
Dec. 15, 2017
USD ($)
Restructuring and Related Activities [Abstract]  
Restructuring expenses $ 322
XML 63 R46.htm IDEA: XBRL DOCUMENT v3.8.0.1
Restructuring Costs - Schedule of Expenses Related to Restructuring (Details)
$ in Thousands
3 Months Ended
Mar. 31, 2018
USD ($)
Accrued obligations $ 200
Settlement of obligations (134)
Accrued obligations 66
Employee Costs [Member]  
Accrued obligations 97
Settlement of obligations (75)
Accrued obligations 22
Other Costs [Member]  
Accrued obligations 103
Settlement of obligations (59)
Accrued obligations $ 44
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[Member] April 2018 [Member] Document And Entity Information Entity Registrant Name Entity Central Index Key Document Type Document Period End Date Amendment Flag Current Fiscal Year End Date Entity Filer Category Entity Common Stock, Shares Outstanding Trading Symbol Document Fiscal Period Focus Document Fiscal Year Focus Statement of Financial Position [Abstract] ASSETS Current assets Cash Accounts receivable, net Inventory Prepaid expenses and other current assets Total current assets Fixed assets, net Intangible assets, net Other non-current assets Total assets LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities Accounts payable Accrued liabilities Deferred rent Current portion of long-term debt Total current liabilities Long-term debt, net of current portion Total liabilities Commitments and contingencies (Note 8) Stockholders' deficit Capital stock Preferred Stock, $0.001 par value, 10,000,000 authorized, 934 and 2,012 issued and outstanding at March 31, 2018 and December 31, 2017, respectively Common stock, $0.001 par value, 40,000,000 authorized, 10,438,998 and 7,986,998 issued and outstanding at March 31, 2018 and December 31, 2017, respectively Additional paid-in capital Accumulated deficit Total stockholders' deficit Total liabilities and stockholders' deficit Preferred stock, par value Preferred stock, shares authorized Preferred stock, shares issued Preferred stock, shares outstanding Common stock, par value Common stock, shares authorized Common stock, shares issued Common stock, shares outstanding Income Statement [Abstract] Revenue Product sales Reader equipment rentals Total revenue Cost of goods sold Cost of goods sold (excluding amortization of intangible assets) Cost of goods sold - reader equipment depreciation Gross profit Operating expenses Sales and marketing Clinical, regulatory and research & development General and administrative Total operating expenses Income (loss) from operations Other income (expense) Interest income (expense) Other, net Total other income (expense) Net loss and comprehensive loss Weighted average shares outstanding - basic and fully diluted Net loss per share Statement of Cash Flows [Abstract] OPERATING ACTIVITIES Net loss for the period Adjustments to reconcile net loss to cash used in operating activities: Stock-based compensation Depreciation of fixed assets Amortization of intangible assets Deferred interest on long-term debt Amortization of debt discount Changes in operating assets and liabilities: Accounts receivable, net Inventory Prepaid expenses and other assets Accounts payable Accrued liabilities Deferred rent/revenue Cash provided by (used in) operating activities INVESTING ACTIVITIES Additions to fixed assets Cash used in investing activities FINANCING ACTIVITIES Repurchase of fractional shares upon reverse stock split Proceeds from the issuance of employee stock purchase plan shares Cash provided by financing activities Increase (decrease) in cash and cash equivalents during the period Cash, beginning of period Cash, end of period Supplemental cash flow information Cash paid for interest Organization, Consolidation and Presentation of Financial Statements [Abstract] Basis of Presentation Accounting Policies [Abstract] Significant Accounting Policies Balance Sheet Details Goodwill and Intangible Assets Disclosure [Abstract] Intangible Assets Debt Disclosure [Abstract] Term Loan Equity [Abstract] Stockholders' Equity Earnings Per Share [Abstract] Net Income (Loss) Per Share Commitments and Contingencies Disclosure [Abstract] Commitments and Contingencies Restructuring and Related Activities [Abstract] Restructuring Costs Use of Estimates Revenue Recognition Use, Masters, and Flex Agreements Purchase Agreements Arrangements with Multiple Performance Obligations Return Reserve Practical Expedients and Exemptions Recent Accounting Pronouncements Schedule of Disaggregated Revenues Schedule of Accounts Receivable Schedule of Inventory Summary of Prepaid Expenses and Other Current Assets Schedule of Fixed Assets Schedule of Accrued Liabilities Schedule of Amortization of Intangible Assets Schedule of Estimated Amortization Expense of Intangible Assets Schedule of Term Loan Schedule of Maturities of Outstanding Principal of Term Loan Schedule of Common and Preferred Shares Schedule of Stock-Based Compensation Expense Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share Schedule of Future Minimum Payments Schedule of Expenses Related to Restructuring Net income (loss) Shipping and handling fee Reserve of product sales Total revenue Statement [Table] Statement [Line Items] Depreciation expense Royalty percentage Trade receivables Allowance for doubtful accounts Accounts receivable net Finished goods Inventory reserves Inventory net Prepaid trade shows Prepaid insurance Manufacturing deposits Subscriptions Other fees and services Prepaid expense and other current assets Property plant and equipment, gross Less accumulated depreciation Property plant and equipment net Due to professionals Due to employees and directors Sales and use tax liabilities Royalty liability Warranty Restructuring Other Accrued liabilities current Amortization expense Useful Life (Years) Gross Value Accumulated Amortization Net Book Value Remainder of 2018 Thereafter Total Long-term debt Proceeds from issuance of long-term debt Debt instrument date Debt instrument interest rate percentage Warrants to purchase common shares Warrants exercise price Warrants term Facility fee percentage on principal Minimum liquidity covenant amount Payment of liquidity covenant Term loan minimum annual revenue threshold Ownership percentage Minimum cash balance Financing and legal fees to long-term debt Percentage of prepayment fee Percentage of reduction in annual prepayment fee Principal balance outstanding PIK interest Facility fee Deferred financing fees, net Detachable warrants, net Total Less, current portion of Term loan Total Term Loan 2018 2019 2020 Total principal due Less: discount on term loan Total term loan Derivative Instrument [Axis] Common stock shares authorized Common stock par value Preferred stock shares authorized Preferred stock par value Reserve stock split Stock issued during period, shares new issue Preferred stock, issued Proceeds from issuance or sale of equity Payments of stock issuance costs Common stock, conversion basis Share-based compensation number of shares reserved for issuance Share-based compensation common stock purchase price percentage Share-based compensation expiration period Percentage of options exercisable at a rate Expected weighted-average period Common stock capital shares reserved for future issuance Employee stock purchase plan offering period Share-based compensation employee stock purchase plan contribution percentage Share-based compensation employee stock purchase plan contribution maximum amount Share-based compensation employee stock purchase plan contribution maximum number of shares Allocated share-based compensation expense Stock issued during period number of shares of employee stock purchase plans Class of warrant or right number of securities called by warrants or rights Class of warrant or right exercise price of warrants or rights Warrants exercisable date Fair value of warrants Fair value assumptions expected volatility rate Fair value assumptions expected term Fair value assumptions risk free interest rate Fair value assumptions dividend yield Warrant expiration date, description Stock-based compensation expense before income taxes Antidilutive securities number of shares Royalty payment, percentage Revenue milestone payments Revenue milestone payment percentage Royalty payments Maximum royalty payable on sale of combined products Purchase commitment remaining minimum amount committed annual volume Marketing fee payments due Minimum percentage of purchase Loss contingency damages paid 2018 2019 2020 2021 2022 Thereafter Total Restructuring expenses Accrued obligations Settlement of obligations Accrued obligations Black-Scholes Merton Model [Member] CRG Warrants [Member] Capitalized Tear Lab Equipment [Member] CRG LP Additional Warrants [Member] CRG LP [Member] Represents the employee stock purchase plan adopted during the period. ESPP Shares [Member]. Element represents title of individuals. Marketing Agreement [Member] Medical Equipment [Member] MiniFAB [Member] Non-statutory stock type options. Ocu Hub Business Unit [Member] Officer Director Or Consultant [Member] Patents And Trademarks [Member] Placement Agent Warrants [Member] Prepaid Manufacturing Deposits Current, Prepaid Subscriptions Current. Prepaid Trade Shows Current. Prescriber List [Member] Represents reader equipment rental revenues. Schedule of Common and Preferred Shares [Table Text Block] Second Tranche [Member]. Series A Convertible Preferred Stock [Member] Series A Warrants [Member] Name of share-based compensation plan. Supply Agreement [Member] Tear Lab Technology [Member] Term Loan Agreement [Member] Term Loan [Member]. 2006 Agreement [Member] 2003 Agreement [Member] 2018 [Member] 2019 [Member] 2017 [Member] 2020 [Member] One Supplier [Member] United States [Member] Rest of World [Member] State [Member] Canadian [Member] Represents operating loss carryforwards related to stock option exercises. Restructuring. Warrants term. Term loan minimum annual revenue threshold. Percentage of term loan prepayment fee rate. Percentage of reduction in annual prepayment fee. Series B Warrants [Member] Warrants [Member] Percentage of options exercisable at a rate. Represents the offering period for the employee stock purchase plan. The employees maximum payroll percentage deduction allowable towards the purchase of common stock under the Employee Stock Purchase Plan. The employees maximum amount allowable towards the purchase of common stock under the Employee Stock Purchase Plan during each calendar year. The employees maximum amount allowable to invest (shares) Employee Stock Purchase Plan during the offering period. Warrants exercisable date. Warrant expiraton date, description. United States Tax Reform [Member] Royalty payment, percentage. Maximum royalty payable on sale of combined products. Purchase Commitment Remaining Minimum Amount. Marketing fee payments due. Minimum percentage of purchase. Settlement of obligations. Preferred Stock One [Member]. OcuHub Holdings, Inc [Member] Use, Masters, and Flex Agreements [Policy Text Block] Purchase Agreements [Policy Text Block] Arrangements with Multiple Performance Obligations [Policy Text Block] Return Reserve [Policy Text Block] Practical Expedients and Exemptions [Policy Text Block] Royalty percentage. April 4, 2018 [Member] May 1, 2018 [Member] Restated License Agreement [Member] Revenue milestone payment percentage. Minimum liquidity covenant amount. Payment of liquidity covenant. Detachable warrants, net. i-Med Pharma, Inc. [Member] April 2018 [Member] TermLoanAgreementMember Assets, Current Assets Liabilities, Current Liabilities Stockholders' Equity Attributable to Parent Liabilities and Equity Gross Profit Operating Expenses Operating Income (Loss) Nonoperating Income (Expense) Increase (Decrease) in Accounts Receivable Increase (Decrease) in Inventories Increase (Decrease) in Prepaid Expense and Other Assets Increase (Decrease) in Accounts Payable Increase (Decrease) in Accrued Liabilities Net Cash Provided by (Used in) Operating Activities Payments to Acquire Property, Plant, and Equipment Net Cash Provided by (Used in) Investing Activities Payments for Repurchase of Other Equity Net Cash Provided by (Used in) Financing Activities Cash and Cash Equivalents, Period Increase (Decrease) Allowance for Doubtful Accounts Receivable, Current Inventory Valuation Reserves Accumulated Depreciation, Depletion and Amortization, Property, Plant, and Equipment Finite-Lived Intangible Assets, Net Debt Issuance Costs, Current, Net Debt Instrument, Unamortized Discount Contractual Obligation, Due in Next Fiscal Year Contractual Obligation, Due in Second Year Contractual Obligation, Due in Third Year Contractual Obligation, Due after Fifth Year Contractual Obligation Restructuring Reserve EX-101.PRE 17 tear-20180331_pre.xml XBRL PRESENTATION FILE XML 18 R1.htm IDEA: XBRL DOCUMENT v3.8.0.1
Document and Entity Information - shares
3 Months Ended
Mar. 31, 2018
May 07, 2018
Document And Entity Information    
Entity Registrant Name TearLab Corp  
Entity Central Index Key 0001299139  
Document Type 10-Q  
Document Period End Date Mar. 31, 2018  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity Filer Category Smaller Reporting Company  
Entity Common Stock, Shares Outstanding   10,438,998
Trading Symbol TEAR  
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2018