0001493152-17-005344.txt : 20170515 0001493152-17-005344.hdr.sgml : 20170515 20170515165023 ACCESSION NUMBER: 0001493152-17-005344 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 56 CONFORMED PERIOD OF REPORT: 20170331 FILED AS OF DATE: 20170515 DATE AS OF CHANGE: 20170515 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: 17845167 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 form10-q.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, 2017

 

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

 

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

 

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

Yes [  ] No [X]

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 5,735,732 as of May 8, 2017.

 

 

 

 
 

 

    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 21
Item 3. Quantitative and Qualitative Disclosures about Market Risk 28
Item 4. Controls and Procedures 28
     
     
PART II. OTHER INFORMATION  
     
Item 1. Legal Proceedings 29
Item 1A. Risk Factors 30
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 43
Item 3. Defaults Upon Senior Securities 43
Item 4. Mine Safety Disclosures 43
Item 5. Other Information 43
Item 6. Exhibits 43

 

 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;
The planned continued commercialization of our current product;
Our ability to expand into next generation products;
Our ability to meet the financial covenants under our credit facilities;
Use of cash, cash needs and ability to raise capital;
The size and growth of the potential markets for our product and technology;
The effect of our strategy to streamline our organization and lower our costs;
The adequacy of current, and the development of new distributor, reseller, and supplier relationships, and our efforts to expand relationships with distributors and resellers in additional countries;
Our anticipated expansion of United States and international sales and operations;
Our ability to obtain and protect our intellectual property and proprietary rights;
The results of our clinical trials;
Our ability to maintain reimbursement for our product and support our pricing strategies;
Our plan to continue to develop and execute our conference and podium strategy to ensure visibility and evidence-based positioning of the TearLab® Osmolarity System among eye care professionals;
Our ability to attract and retain a sufficient number of scientists, clinicians, sales personnel and other key personnel with extensive experience in medical technology, who are in short supply;
Our beliefs about our employee relations;
Our efforts to assist our customers in obtaining their CLIA waiver or providing them with support from certified professionals; and
Our ability to remain listed on the NASDAQ Capital Market.

 

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

 

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

 

 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, 2017   December 31, 2016 
         
ASSETS          
Current assets          
Cash  $13,032   $15,471 
Accounts receivable, net   2,266    2,279 
Inventory   3,324    3,193 
Prepaid expenses and other current assets   1,216    1,226 
Total current assets   19,838    22,169 
           
Fixed assets, net   3,880    4,178 
Intangible assets, net   44    60 
Other non-current assets   220    220 
Total assets  $23,982   $26,627 
           
LIABILITIES AND STOCKHOLDERS’ DEFICIT          
Current liabilities          
Accounts payable  $2,745   $1,858 
Accrued liabilities   4,082    3,958 
Deferred rent   70    83 
Total current liabilities   6,897    5,899 
           
Long-term debt   26,906    26,449 
           
Total liabilities   33,803    32,348 
           
Commitments and contingencies (Note8)          
           
Stockholders’ deficit          
Capital stock          
Preferred Stock, $0.001 par value, 10,000,000 authorized, 757 and 2,764 issued and outstanding at March 31, 2017 and December 31, 2016, respectively        
Common stock, $0.001 par value, 9,500,000 authorized, 5,634,756 and 5,360,198 issued and outstanding at March 31, 2017 and December 31, 2016, respectively   6    5 
Additional paid-in capital   507,302    506,982 
Accumulated deficit   (517,129)   (512,708)
Total stockholders’ deficit   (9,821)   (5,721)
Total liabilities and stockholders’ deficit  $23,982   $26,627 

 

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, 
   2017   2016 
         
Revenue          
Product sales  $5,987   $5,502 
Reader equipment rentals   714    1,265 
Total revenue   6,701    6,767 
Cost of goods sold          
Cost of goods sold  (excluding amortization of intangible assets)   2,542    2,540 
Cost of goods sold - reader equipment depreciation   466    554 
Gross profit   3,693    3,673 
Operating expenses          
Sales and marketing   3,332    4,636 
Clinical, regulatory and research & development   1,564    1,138 
General and administrative   2,187    3,931 
Amortization of intangible assets   -    304 
Total operating expenses   7,083    10,009 
Loss from operations   (3,390)   (6,336)
Other income (expense)          
Interest income (expense)   (1,028)   (883)
Changes in fair value of warrant obligations   -    27 
Other, net   (3)   (62)
Total other income (expense)   (1,031)   (918)
Net loss and comprehensive loss  $(4,421)  $(7,254)
Weighted average shares outstanding  - basic and fully diluted   5,367,311    3,382,567 
Net loss per share  $(0.82)  $(2.14)
           
Weighted average shares outstanding  - diluted   5,367,311    3,382,567 
Net loss per share  – diluted  $(0.82)  $(2.14)

 

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, 
   2017   2016 
         
OPERATING ACTIVITIES          
Net loss for the period  $(4,421)  $(7,254)
Adjustments to reconcile net loss to cash used in operating activities:          
Stock-based compensation   289    714 
Depreciation of fixed assets   521    620 
Amortization of intangible assets   15    315 
Changes in fair value of warrant obligations   -    (27)
Deferred interest on long-term debt   302    292 
Amortization of debt discount   154    43 
Changes in operating assets and liabilities:          
Accounts receivable, net   13    (5)
Inventory   (131)   338 
Prepaid expenses and other assets   10    (475)
Other non-current assets   -    (32)
Accounts payable   889    721 
Accrued liabilities   123    (1,385)
Deferred rent/revenue   (12)   (3)
Cash used in operating activities   (2,248)   (6,138)
           
INVESTING ACTIVITIES          
Additions to fixed assets, net of proceeds   (223)   (500)
Cash used in investing activities   (223)   (500)
           
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   (2,439)   (6,638)
Cash, beginning of period   15,471    13,838 
Cash, end of period  $13,032   $7,200 
           
Supplemental cash flow information          
Cash paid for interest  $571   $552 

 

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

 

The accompanying condensed consolidated financial statements include the accounts of the Company and all of its wholly owned subsidiaries. On April 8, 2016, OcuHub Holdings, Inc., a wholly-owned subsidiary of the Company, completed the sale of 10,167.5 units of OcuHub LLC (“OcuHub”), reducing OcuHub Holdings, Inc.’s ownership in OcuHub to 10.5% on a fully-diluted basis. Prior to the sale, the accounts of OcuHub were included in the condensed consolidated financial statements. Intercompany accounts and transactions have been eliminated on consolidation.

 

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

 

Liquidity and Going Concern

 

The accompanying 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 $4,421 and $7,254 for the three months ended March 31, 2017 and 2016, respectively. Based on the Company’s current rate of cash consumption, the Company estimates it will need additional capital in the first quarter of 2018 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 2018 without violating an existing covenant on the Term Loan Agreement (defined below). As a result of the Company’s historical losses and financial condition, there is substantial doubt about the Company’s ability to continue as a going concern.

 

 

2. SIGNIFICANT ACCOUNTING POLICIES

 

The consolidated balance sheet at December 31, 2016 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, 2016. The audited financial statements for the year ended December 31, 2016, filed with the SEC with the Company’s annual report on Form 10-K on March 10, 2017 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 normally 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

 

Revenue is recognized when all four of the following criteria are met: (i) persuasive evidence that an arrangement exists; (ii) delivery of the products has occurred; (iii) the selling price is fixed or determinable; and (iv) collectability is reasonably assured. The Company records revenue when all of its obligations are completed, which is generally upon shipment of the Company’s products. Amounts received in excess of revenue recognizable are deferred.

 

The Company sells its proprietary TearLab® Osmolarity System and related test cards to external customers, who are primarily eye care professionals, for use in osmolarity testing procedures. Revenue is primarily derived from the sale of disposable test cards. Products are generally shipped from a distribution and warehousing facility located in San Diego, California. The Company’s sales are currently direct to customers in the United States and 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 with sales of multiple deliverables, such as the reader equipment and disposable test cards (referred to as “Purchase Agreements”).

 

Purchase commitments for Use Agreements and Flex Agreements are expressed in the agreement for a specified period of time (generally one to three years). The purchase commitment for Masters Agreements is implied for large physician practices with an expectation of purchasing certain levels of test cards. The Company recovers the cost of providing the reader equipment in the amount charged for disposable test cards. These agreements are treated as operating leases as collectability of the minimum lease payments is not reasonably predictable at the outset of the arrangement. Accordingly, revenue is recognized over the defined contract term as disposable test cards are shipped. Revenue under such agreements is allocated between the lease of the reader equipment and the sale of the disposables based upon each component’s relative fair value. When reader equipment is placed with a customer at no separate cost, the Company retains title to the equipment and it remains capitalized on the Company’s 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.

 

 8  
 

 

TearLab Corporation

 

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

 

Although the Company typically has a no return policy for its products, the Company has established a reserve for product sales that contain an implicit right of return. The Company reserves for estimated returns or refunds by reducing revenues at the time of shipment based on historical experience. The reserve of $11 and $13 as of March 31, 2017 and December 31, 2016, respectively, has reduced revenue and is included in accounts receivable.

 

Recent accounting pronouncements

 

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

 

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

 

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

 

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

 

 9  
 

 

TearLab Corporation

 

3. BALANCE SHEET DETAILS

 

Accounts receivable

 

   March 31, 2017   December 31, 2016 
         
Trade receivables  $2,810   $2,928 
           
Allowance for doubtful accounts   (544)   (649)
   $2,266   $2,279 

 

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, 2017   December 31, 2016 
         
Finished goods  $3,341   $3,210 
Inventory reserves   (17)   (17)
   $3,324   $3,193 

 

The Company evaluates inventory for estimated excess quantities and obsolescence, based on expected future sales levels and projections of future demand, and establishes inventory reserves for obsolete and excess inventories. In addition, the Company assesses the impact of changing technology and market conditions. The Company has entered into a long 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, 2017   December 31, 2016 
Prepaid trade shows   253   $217 
Prepaid insurance   278    326 
Manufacturing deposits   282    282 
Subscriptions   299    297 
Other fees and services   96    66 
Other current assets   8    38 
   $1,216   $1,226 

 

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TearLab Corporation

 

Fixed assets

 

   March 31, 2017   December 31, 2016 
Capitalized TearLab equipment  $9,013   $9,095 
Leasehold improvements   60    60 
Computer equipment and software   920    932 
Furniture and office equipment   272    271 
Medical equipment   747    500 
   $11,012   $10,858 
Less accumulated depreciation   (7,132)   (6,680)
   $3,880   $4,178 

 

Depreciation expense was $521 and $620 during the three months ended March 31, 2017 and 2016, respectively.

 

Accrued liabilities

 

   March 31, 2017   December 31, 2016 
Due to professionals  $118   $81 
Due to employees and directors   2,175    2,200 
Sales and use tax liabilities   225    247 
Royalty liability   402    854 
Warranty   123    124 
Other   1,039    452 
   $4,082   $3,958 

 

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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, was fully amortized in November 2016. Amortization expense for the three months ended March 31, 2017 and 2016 was $15 and $315, respectively.

 

Intangible assets subject to amortization consist of the following:

 

   Remaining          
   Useful Life  Gross Value at    Accumulated   Net Book Value at 
   (Years)  March 31, 2017   Amortization   March 31, 2017 
                
TearLab® technology  0  $12,172   $(12,172)  $- 
Patents and trademarks  1   271    (249)   22 
Prescriber list  1   90    (68)   22 
Total     $12,533   $(12,489)  $44 

 

   Gross Value at   Accumulated   Net Book Value at 
   December 31, 2016   Amortization   December 2016 
             
TearLab® technology  $12,172   $(12,172)  $- 
Patents and trademarks   271    (245)   26 
Prescriber list   90    (56)   34 
Total  $12,533   $(12,473)  $60 

 

The estimated amortization expense for the intangible assets for the remainder of 2017 and thereafter is as follows:

 

   Amortization 
   of intangible 
   assets 
     
Remainder of 2017  $44 
   $44 

 

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 March 31, 2021 and bears interest at 13% per annum, with quarterly payments of interest only for the first four years. While interest on the loan is accrued at 13% per annum, the Company may elect to make interest-only payments at 8.5% per annum. The unpaid interest of 4.5% is added to the principal of the loan and is subject to additional accrued interest (“PIK interest”). The accrued interest can be deferred and paid together with the principal in the fifth and sixth years.

 

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 Consolidated Balance Sheets as of March 31, 2017 and 2016. The CRG Warrants were valued at their issuance date using the Black-Scholes Merton model. The related reduction of the long-term debt will be amortized over the life of the debt.

 

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TearLab Corporation

 

The loan is collateralized by all assets of the Company. Additionally, the terms of the Term Loan Agreement contain various affirmative and negative covenants agreed to by the Company. Among them, the Company must attain minimum certain annual revenue and minimum cash threshold levels. On April 7, 2016, the Company amended the Term Loan Agreement to change the required minimum revenue levels. The amended minimum revenue is $31,000 for 2017, $36,000 for 2018, $45,000 for 2019 and $55,000 for 2020. The minimum cash balance required is $5,000 subject to certain conditions. The amendment also reduced the exercise price of the CRG Warrants from $50.00 per share to $15.00 per share and the Company issued CRG additional warrants to purchase 35,000 common shares of the Company’s stock at $15.00 per share, which expire 5 years after issuance.

 

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, 2017, the Company was in compliance with all of the covenants.

 

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

 

The Company incurred financing and legal fees associated with the debt of $606, which were recorded as a direct discount to the debt and are being amortized using the effective interest method. The Company presents the debt issuance costs related to the recognized debt liability on the 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, 2017 and related maturities of outstanding principal:

 

Prinicpal balance outstanding  $25,000 
PIK interest   2,179 
Facility fee   428 
less discount on term loan:     
deferred financing fees, net   (404)
detachable warrants, net   (297)
Total term loan  $26,906 

 

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TearLab Corporation

 

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

 

2017   - 
2018   - 
2019   10,192 
2020   13,590 
2021   3,825 
Total principal due   27,607 
Less: discount on term loan   (701)
Total term loan  $26,906 

 

6. STOCKHOLDERS’ EQUITY

 

(a) Authorized share capital

 

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

 

On June 24, 2016, the Company’s stockholders approved an amendment to the Company’s certificate of incorporation to increase the total number of authorized shares of common stock of the Company to 9,500,000 from 6,500,000. Each share of common stock has a par value of $0.001 per share. The total number of authorized shares of preferred stock of the Company is 10,000,000. Each share of preferred stock has a par value of $0.001 per share.

 

(b) Common and preferred shares

 

On May 9, 2016 the Company issued 1,861,090 shares of common stock, 3,291.8 shares of Series A Convertible Preferred Stock (“Preferred Stock”) and Series A warrants to purchase 1,150,000 shares of common stock (“Series A Warrants”) for gross proceeds of $17,250, less issuance costs of $1,793. Additionally, the Company granted the placement agent warrants to purchase 103,500 shares of common stock with an exercise price of $11.25 per share. The Preferred Stock is convertible, subject to certain limitations, into an aggregate of 438,910 shares of common stock, contains no voting rights, participates in any common stock dividends, and is treated as if converted upon any ordinary liquidation event. The common stock, the Series A Convertible Preferred Stock, and the Series A Warrants are all included in equity in the Company’s Consolidated Balance Sheets as of December 31, 2016. The net proceeds were allocated to common stock, Preferred Stock, and Series A Warrants based on their relative fair values, as follows:

 

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

 

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TearLab Corporation

 

On August 2, 2016, 527.5 shares of Series A Convertible Preferred stock was converted into 70,333 shares of common stock. On March 31, 2017, 2,007 shares of Series A Convertible Preferred stock was converted into 267,600 shares of Common stock. On April 3, 2017, subsequent to the March 31, 2017 balance sheet date, the remaining 757 shares of Series A Convertible Preferred stock were converted into 100,976 shares of common stock.

 

(c) Stock Incentive Plan

 

The Company has a stock incentive plan, the 2002 Stock Incentive Plan (the “Stock Incentive Plan”), under which up to 720,000 options are available for grant to employees, directors and consultants. Options 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.

 

The Company accounts for stock-based compensation awards and share-based payment transactions with employees based on the fair value of the award at the time of grant and recognizes 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, 
   2017   2016 
         
Sales and marketing  $146   $136 
Clinical, regulatory and research and development   43    83 
General and administrative   100    495 
Stock-based compensation expense before income taxes  $289   $714 

 

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TearLab Corporation

 

(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 67,150 shares of the Company’s common stock are reserved for issuance under the plan, which permits eligible employees to purchase common stock at a discount through payroll deductions.

 

The price at which stock is purchased under the ESPP is equal to 90% of the fair market value of the common stock on the first or the last day of the offering period, whichever is lower. Generally, each offering under the ESPP will be for a period of six months as determined by the Company’s Board of Directors. Employees may invest up to 20% of their gross compensation through payroll deductions. In no event may an employee 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, 2017 and 2016, the Company recorded $3 of expense, respectively, under the ESPP. During the three months ended March 31, 2017 and 2016, the Company issued 7,512 and 6,774 shares of common stock under the ESPP, respectively.

 

(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 Consolidated Balance Sheets as of March 31, 2017 and December 31, 2016. The CRG Warrants were valued at $290 upon issuance using the Black-Scholes Merton model assuming volatility of 73%, an expected life of 5.0 years, a risk-free interest rate of 1.71%, and 0% dividend yield. No CRG Warrants were exercised during the three months ended March 31, 2017 or 2016.

 

On April 8, 2016, the Company further amended its Term Loan Agreement. As part of the amendment, the exercise price of the CRG Warrants was changed to allow the holder to purchase 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.

 

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TearLab Corporation

 

(f) Exchange Right

 

In August 2014, the Company sold membership units in OcuHub in exchange for 2% ownership of OcuHub LLC. In connection with the sale of the membership units, the new members received an exchange right allowing the units to be exchanged upon written notice and during a specified exchange window for shares in the Company’s common stock. On March 31, 2016, the members exchanged the ownership interest in OcuHub LLC for 385,800 shares of the Company’s common stock.

 

7. NET INCOME (LOSS) PER SHARE

 

Basic 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:

 

   Three Months Ended 
(in thousands of shares)  March 31, 
   2017   2016 
Stock options   706    638 
Warrants   1,324    64 
ESPP shares   3    8 
Convertible preferred shares   102    - 
           
Total   2,135    710 

 

8. COMMITMENTS AND CONTINGENCIES

 

Commitments

 

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

 

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

 

Future minimum royalty payments under this agreement as of March 31, 2017 are as follows:

 

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

 

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TearLab Corporation

 

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

 

Future minimum royalty payments under this agreement as of March 31, 2017 are as follows:

 

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

 

On March 7, 2016, the Company, through its subsidiary, TearLab Research, Inc., entered into a supply and development agreement (“Supply Agreement”) with MiniFAB (Aust) Pty Ltd (“MiniFAB”). The agreement is an exclusive supply agreement through June 2021, 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 July 2011 agreement between MiniFAB and the Company.

 

In April 2014, the Company guaranteed a marketing agreement entered into by OcuHub. The underlying marketing agreement calls for an annual marketing fee of $100, with payments due quarterly through March 31, 2019. If OcuHub fails to perform its obligations under the terms of the marketing agreement, the Company would be required to make the $25 quarterly payments, through the March 31, 2019 initial term of the agreement. The Company has not accrued for any liability under the guarantee.

 

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

 

Contingencies

 

During the ordinary course of business activities, the Company may be contingently liable for litigation and a party to claims. Currently the Company is not party to any litigation.

 

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TearLab Corporation

 

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 based in San Diego, California. We have commercialized a proprietary tear testing platform, the TearLab® Osmolarity System that enables eye care practitioners to test for 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 are developing technology 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. While our current focus is on developing our business in the United States, we do have agreements with numerous distributors for distribution of the TearLab® Osmolarity System in Canada South America, Europe, Asia and Australia.

 

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TearLab Corporation

 

RESULTS OF OPERATIONS

 

Revenue, Cost of Sales and Gross Margin

 

(in thousands)  Three months ended
March 31,
 
   2017   2016   Change 
             
TearLab revenue  $6,701   $6,767   $(66)
TearLab – cost of sales   3,008    3,094    (86)
TearLab gross profit   3,693    3,673    20 
Gross profit  percentage   55%   54%     

 

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) approval from the FDA in the United States, we sell to customers in the United States who hold CLIA moderate and high complexity certificates and actively support and assist our customers to obtain their certificates 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 Canada, Europe, South America, and Asia 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 was $6.7 million for the three months ended March 31, 2017 compared to $6.8 million for the three months ended March 31, 2016. A 1% decline in the volume of test cards sold was partially offset by $130,000 of revenue from a cooperative marketing agreement, which we refer to as the Marketing Agreement, which we entered into in November 2016 with PRN Physician Recommended Neutriceuticals, LLC.

 

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TearLab Corporation

 

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 decreased for the three months ended March 31, 2017 to $3.0 million from $3.1 million for the three months ended March 31, 2016. The decrease in cost of sales was driven by a decline in the volume of test cards shipped.

 

Gross Profit

 

TearLab gross profit for the three months ended March 31, 2017 is flat at $3.7 million compared to the three months ended March 31, 2016. The gross profit percentage of revenue for the three months ended March 31, 2017 was 55% compared to 54% for the three months ended March 31, 2016. The improvement in gross profit percentage was driven by the inclusion of revenue this quarter from the Marketing Agreement.

 

Operating Expenses

 

(in thousands)  Three months ended March 31, 
   2017   2016   Change 
             
Sales and marketing  $3,332   $4,636   $(1,304)
Clinical, regulatory and research and development   1,564    1,138    426 
General and administrative   2,187    3,931    (1,744)
Amortization of intangible assets   -    304    (304)
Operating expenses  $7,083   $10,009   $(2,926)

 

Sales and Marketing Expense

 

Sales and marketing expenses decreased by $1.3 million or 28% in the three months ended March 31, 2017, as compared with the three months ended March 31, 2016. The reduction in sales and marketing expenses is attributable to cost savings from our February 2016 organizational restructuring and cost savings from the divestiture of our OcuHub subsidiary in April 2016.

 

Clinical, Regulatory and Research and Development Expenses

 

Total clinical, regulatory and research and development expenses increased $426,000 or 37% in the three months ended March 31, 2017 as compared with the three months ended March 31, 2016. The increase in expense was primarily due to an increase in external product development costs related to our next generation of products.

 

General and Administrative Expenses

 

Total general and administrative expenses decreased $1.7 million or 44% in the three months ended March 31, 2017 as compared with the three months ended March 31, 2016. The decrease when compared to the prior period was primarily due to costs incurred in 2016 associated with our former subsidiary, OcuHub, lower legal and professional services because of a planned common stock offering we withdrew in the first quarter of 2016, and lower stock compensation as certain option grants fully vested.

 

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TearLab Corporation

 

Amortization of Intangible Assets

 

Amortization expense of intangible assets for the three months ended March 31, 2017 was $0, compared to the $0.3 million in the prior year fiscal period. The TearLab® technology fully amortized during 2016 so there was no comparable expense for the three months ended March 31, 2017.

 

Other Income (Expense)

 

(in thousands)  Three Months Ended
March 31,
 
   2017   2016   Change 
             
Interest income (expense)  $(1,028)  $(883)  $(145)
Changes in fair value of warrant obligations   -    27    (27)
Other (net )   (3)   (62)   59 
Other income  $(1,031)  $(918)  $(113)

 

Interest Income (Expense)

 

Interest expense for the three months ended March 31, 2017 and 2016 was from our long-term debt under the Term Loan Agreement. Interest expense increased for the three months ended March 31, 2017 when compared to the same period in the previous fiscal year on larger average balances of long-term debt outstanding and because of the impact of warrants issued to the lenders and changes to the facility fee from amendments to the original term loan agreement.

 

Changes in Fair Value of Warrants Obligations

 

The Company records outstanding warrants considered liabilities at fair value at the end of each reporting period, resulting in an adjustment to the warrant obligations, with any gain or loss recorded in earnings for the applicable period. The Company had no warrants with liability treatment outstanding during the three months ended March 31, 2017, and, accordingly, had no associated fair value adjustment during the period. The Company recorded income related to a decrease in the fair value of warrant obligations of $27,000 for the three months ended March 31, 2016.

 

Other (net)

 

Other income (loss) for the three months ended March 31, 2017 and 2016 consists primarily of foreign exchange transaction gains and losses, based on fluctuations of the Company’s foreign denominated currencies. During the three months ended March 31, 2017, the Company had fewer supplier contracts denominated in currencies other than the U.S. dollar and we reduced the balance of Canadian dollars on hand, both of which minimized our exposure to foreign currency gains and losses.

 

 24 
 

 

Liquidity and Capital Resources

 

(in thousands)  March 31, 2017   December 31, 2016   Change 
Cash and cash equivalents  $13,032   $15,471   $(2,439)
Percentage of total assets   54.3%   58.1%     
                
Working capital  $12,941   $16,270   $(3,329)

 

Financial Condition

 

Based on our current rate of cash consumption, we estimate we will need additional capital during the first quarter of 2018 and our prospects for obtaining that capital are uncertain. The Company 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 we succeed in raising additional capital or we significantly reduce the cash consumed in the operations of the Company, we anticipate that we will be unable to continue our operations through the end of the first quarter of 2018, without violating an existing covenant on the Term Loan Agreement. As a result of the Company’s historical losses and financial condition, there is substantial doubt about the Company’s ability to continue as a going concern.

 

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

 

  whether government and third-party payers agree to reimburse the TearLab® Osmolarity System;
  whether eye care professionals engage in the process of obtaining their CLIA waiver certification;
  whether or not we can increase our international sales and register with additional health departments in more markets outside of the United States;
  the costs and timing of building the infrastructure to market and sell the TearLab® Osmolarity System;
  the cost and results of continuing development of the TearLab® Osmolarity System;
  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 can expect to begin to generate significant revenues from the TearLab Osmolarity System in the United States.

 

Further, a successful transition to attaining profitable operations is dependent upon obtaining sufficient financing to fund the Company’s planned expenses and achieving a level of revenue adequate to support the Company’s cost structure. 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 in 2017 which could have an adverse impact on our ability to continue our normal business operations.

 

On March 9, 2017, the Company announced that it was beginning a process to explore strategic alternatives. The Company has engaged an investment bank to assist in the evaluation of strategic alternatives, and the Company is continuing this process currently. However, there can be no assurances that the Company will be able to successfully identify and execute on any definitive plans from this process.

 

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TearLab Corporation

 

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. The Term Loan Agreement has a term of six years and bears interest at 13% per annum, with quarterly payments of interest only for the first four years. At the Company’s option, during the first four years a portion of the interest payments amounting to a 4.5% per annum rate may be deferred and paid together with the principal in the fifth and sixth years.

 

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 2017 is $31.0 million. The minimum cash balance required is $5.0 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 2018. 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 grow our point-of-care revenue.

 

We expect our primary uses of cash will be to fund our operating expenses and pursuing and maintaining our patents and trademarks. In addition, dependent on available funds, we expect to expend cash to pursue additional applications for the lab-on-a-chip technology.

 

Changes in Cash Flows

 

Cash Used in Operating Activities

 

Net cash used to fund our operating activities during the three months ended March 31, 2017 was $2.2 million. Net cash used in operating activities during the three month period was less than our net loss of $4.4 million primarily due to the amortization of intangible assets, depreciation of fixed assets, stock-based compensation and deferred interest and the amortization of the discount on our long-term debt. In aggregate, these non-cash items totaled $1.3 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, 2017 and 2016 consists of the following:

 

   Three Months Ended 
(in thousands)  March 31, 
   2017   2016 
Changes in operating assets and liabilities:          
           
Accounts receivable, net  $13   $(5)
Inventory   (131)   338 
Prepaid expenses and other assets   10    (475)
Other non-current assets   -    (32)
Accounts payable   889    721 
Accrued liabilities   123    (1,385)
Deferred rent/revenue   (12)   (3)
   $892   $(841)

 

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 increased in the three months ended March 31, 2017 due to the timing of orders and receipts from our key supplier.
   
Accounts payable and accrued liabilities had a net increase during the three months ended March 31, 2017 due primarily to timing on payment of product development costs and accrued compensation amounts.

 

Cash Used in Investing Activities

 

Net cash used in investing activities for the three months ended March 31, 2017 and 2016 was $223,000 and $500,000, respectively, to acquire fixed assets, primarily TearLab Osmolarity systems.

 

Cash Provided by Financing Activities

 

There was $32,000 in net cash provided by financing activities during the three months ended March 31, 2017 primarily pertaining to proceeds from the issuance of common stock under our employee stock purchase plan. For the three months ended March 31, 2016, there was no net cash provided by or used in financing activities.

 

Off-Balance-Sheet Arrangements

 

As of March 31, 2017, 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, 2017 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, 2016. For further clarification with regards to the Company’s specific policies for revenue recognition, see Note 2 of the Notes to the Unaudited Condensed Consolidated Financial Statements for the three months ended March 31, 2017 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, 2017 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 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, 2017 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 2017, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS.

 

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.

 

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TearLab Corporation

 

ITEM 1A. RISK FACTORS.

 

Risks Relating to Our Financial Condition

 

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

 

We have prepared our 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 will need to raise additional capital prior to the end of the first quarter of 2018, and cannot assure you that we will be able to do so. We do not currently have any available borrowing under our term loan or credit facility.

 

Our consolidated financial 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, 2017, we had an accumulated deficit of $517.1 million. Our losses have resulted primarily from expenses incurred in research and development of our product candidates from the former retina and glaucoma business divisions. We do not know when or if we will successfully commercialize the TearLab® Osmolarity System in the United States or in international markets. As a result, and because of the numerous risks and uncertainties facing us, it is difficult to provide the extent of any future losses or the time required to achieve profitability, if at all. Any failure to become and remain profitable would require us to undertake a review of the potential business alternatives discussed above.

 

We will need to raise additional capital in the near 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.

 

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

 

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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, premium, if any, and interest on our existing or future indebtedness. If our cash flows and capital resources are insufficient to fund our debt service obligations, we may be forced to reduce or delay capital expenditures, sell assets or operations, seek additional capital or restructure or refinance our indebtedness. We cannot assure you that we would be able to take any of these actions, or that these actions would permit us to meet our scheduled debt service obligations. In addition, in the event of our breach of the Term Loan Agreement with CRG, we may not be allowed to draw additional amounts under the agreement, we may be required to repay any outstanding amounts earlier than anticipated, and the lenders may foreclose on their security interest in our assets.

 

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

 

If we do not have annual revenue greater or equal to the annual revenue covenant in a calendar year, we will have the right to 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 with CRG, we may not be allowed to draw additional amounts under the Term Loan Agreement, we may be required to repay any outstanding amounts earlier than anticipated, and the lenders may foreclose on their security interest in our assets.

 

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

 

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

 

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

 

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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;
  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.

 

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

 

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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 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 be successfully commercialized. If the TearLab® Osmolarity System is not as successfully commercialized as expected, we may not be able to generate revenue, 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, 2017, our total liabilities were $33.8 million including $26.9 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; 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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TearLab Corporation

 

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

 

There are numerous risks and uncertainties inherent in the development of new medical technologies. In addition to our requirement for additional capital, our ability to 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:

 

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

 

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 also announces 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. Although it is very early to understand if reimbursement for our product or future products will be impacted, the act does provide a maximum reimbursement reduction of 10% per year for the years 2018 through 2020. For years 2021 through 2023, the maximum reduction on the reimbursement rate is 15%. Should reimbursement for our products be reduced as a result of PAMA, this could negatively impact our pricing and commercialization of our products in the U.S.

 

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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. We are currently involved in litigation defending our patent rights in Canada. Efforts to defend our rights could incur significant costs and may or may not be resolved in our favor. We could become a party to additional patent litigation and other proceedings. The cost to us of any patent litigation, even if resolved in our favor, could be substantial. Some of our would-be competitors may sustain the costs of such litigation more effectively than we can because of their greater financial resources. Litigation also may absorb significant management time.

 

 36 
 

 

TearLab Corporation

 

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.

 

 37 
 

 

TearLab Corporation

 

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

 

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

 

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

 

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

 

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

 

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

 

We face intense competition in the markets for ophthalmic products and these markets are subject to rapid and significant technological change. 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.

 

 38 
 

 

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.

 

 39 
 

 

TearLab Corporation

 

Risks Related to Our Common Stock

 

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

 

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

 

On September 16, 2016, we received a letter from the NASDAQ Listing Qualifications Staff (the “Staff”), which indicated the Staff had determined to delist our securities from The Nasdaq Capital Market due to our continued non-compliance with the Minimum Bid Price Rule. To regain compliance with the Minimum Bid Price Rule, we filed a certificate of amendment to our amended and restated certificate of incorporation to effect (i) a reverse stock split of all of the outstanding shares of our common stock and those shares held by us in treasury stock, if any, at a ratio of one-for ten shares, and (ii) a reduction in the total number of authorized shares of our common stock from 95,000,000 to 9,500,000. As of May 8, 2017, the last reported sale price of our common stock was $1.95 per share.

 

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

 

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

 

On May 10, 2017, we received notice from the Staff that the Staff had determined to delist our securities from The Nasdaq Capital Market due to our continued non-compliance with the MVLS requirement, unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”). The Company plans to request a hearing before the Panel, which request will stay any de-listing actions by Nasdaq. At the hearing, we will present our plan to demonstrate compliance with the MVLS requirement and request an extension of time within which to comply with at least one of the alternative listing standards under NASDAQ Listing Rule 5550(b).

 

 40 
 

 

TearLab Corporation

 

If we fail to regain compliance with one of the applicable requirements, our stock may be delisted. 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 would likely be made more difficult and the trading volume and liquidity of our stock could decline. 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, if we are delisted, we would also incur additional costs under state blue sky laws in connection with any sales of our securities. These requirements could severely limit the market liquidity of our common stock and the ability of our stockholders to sell our common stock in the secondary market.

 

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

 

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

 

The trading price of our common stock may be volatile.

 

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

 

  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
  failure to maintain our NASDAQ listing.

 

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.

 

 41 
 

 

TearLab Corporation 

 

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.

 

 42 
 

 

TearLab Corporation

 

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
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    

 

*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

 

 43 
 

 

TearLab Corporation

 

SIGNATURE

 

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

 

        TearLab Corp.
        (Registrant)
         
Date:   May 15, 2017   /s/ Joseph Jensen
        Joseph Jensen
        Chief Executive Officer

 

 44 
 

EX-31.1 2 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 15, 2017

 

  /s/ Joseph Jensen
  Joseph Jensen
  Chief Executive Officer

  

   

 

EX-31.2 3 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, Wes Brazell, 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 15, 2017

 

   /s/ Wes Brazell
  Wes Brazell
  Chief Financial Officer

 

   

 

 

EX-32.1 4 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, 2017, 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 15, 2017

 

   

 

 

EX-32.2 5 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, 2017, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Wes Brazell, 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/ Wes Brazell
    Wes Brazell
    Chief Financial Officer

 

Dated:   May 15, 2017

 

   

 

 

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Report Date [Axis] 2017 [Member] 2018 [Member] 2019 [Member] 2020 [Member] Antidilutive Securities [Axis] Stock Options [Member] Warrants [Member] ESPP Shares [Member] Supply Agreement [Member] Sale of Stock [Axis] MiniFAB [Member] Equity Components [Axis] CRG LP Additional Warrants [Member] Black-Scholes Merton Model [Member] Series A Convertible Preferred Stock [Member] Series A Warrants [Member] Common Stock [Member] Marketing Agreement [Member] Legal Entity [Axis] Convertible Preferred Shares [Member] Other Commitments [Axis] 2006 Agreement [Member] 2003 Agreement [Member] Placement Agent Warrants [Member] Series A Convertible Preferred Stock [Member] Asset Class [Axis] Indefinite-lived Intangible Assets [Member] April 3, 2017 [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 Total current liabilities Long-term debt Total liabilities Commitments and contingencies (Note8) Stockholders’ deficit Capital stock Preferred Stock, $0.001 par value, 10,000,000 authorized, 757 and 2,764 issued and outstanding at March 31, 2017 and December 31, 2016, respectively Common stock, $0.001 par value, 9,500,000 authorized, 5,634,756 and 5,360,198 issued and outstanding at March 31, 2017 and December 31, 2016, 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 outstanding Preferred stock, shares issued 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 Amortization of intangible assets Total operating expenses Loss from operations Other income (expense) Interest income (expense) Changes in fair value of warrant obligations Other, net Total other income (expense) Net loss and comprehensive loss Weighted average shares outstanding  - basic and fully diluted Net loss per share Weighted average shares outstanding  - diluted Net loss per share  – diluted 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 Changes in fair value of warrant obligations 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 Other non-current assets Accounts payable Accrued liabilities Deferred rent/revenue Cash used in operating activities INVESTING ACTIVITIES Additions to fixed assets, net of proceeds 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 Use of Estimates Revenue Recognition Recent Accounting Pronouncements 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 Statement [Table] Statement [Line Items] Schedule of Future Minimum Payments Owned subsidiary, in units Ownership percentage Reserve stock split Net income (loss) Reserve of product sales Depreciation expense 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 Other current assets 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 Other Accrued liabilities current Amortization expense Remaining Useful Life (Years) Gross Value Accumulated Amortization Net Book Value Remainder of 2017 Total 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 Term loan minimum annual revenue threshold Minimum cash balance Financing and legal fees to long-term debt Facility fee percentage on principal Percentage of prepayment fee Percentage of reduction in annual prepayment fee Principle balance outstanding PIK interest Facility fee Deferred financing fees, net Fair value of detachable warrants, net Total term loan 2017 2018 2019 2020 2021 Total principal due Less: discount on term loan Total term loan Common stock shares authorized Common stock shares authorized previously Common stock par value Preferred stock shares authorized Preferred stock par value Stock issued during period, shares new issue Preferred stock, issued Proceeds from issuance or sale of equity Payments of stock issuance costs Share issued price per share Common stock, conversion basis Number of preferred stock converted into common stock Number of preferred stock converted into common stock, shares Share-based compensation number of shares available for grant Share-based compensation common stock purchase price percentage Share-based compensation expiration period Percentage of ownership exercisable options expire Percentage of options exercisable at a rate Weighted-average fair value of stock options granted 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 Fair value of warrants Warrants exercisable date Fair value assumptions expected volatility rate Fair value assumptions expected term Fair value assumptions risk free interest rate Fair value assumptions dividend yield Membership unit percentage Stock-based compensation expense before income taxes Antidilutive securities number of shares Lease expiration date Royalty payments Royalty payment, percentage Royalty description Maximum royalty payable on sale of combined products Purchase commitment remaining minimum amount committed annual volume Marketing fee payments due Minimum percentage of purchase Annual marketing fee Marketing agreement, quarterly payments 2017 2018 2019 2020 2021 Thereafter Total Black-Scholes Merton Model [Member] CRG Warrants [Member] Canadian [Member] Capitalized Tear Lab Equipment [Member] Common stock shares authorized previously. CRG LP Additional Warrants [Member] CRG LP [Member] Represents the employee stock purchase plan adopted during the period. Represents the offering period for the employee stock purchase plan. ESPP Shares [Member]. Element represents title of individuals. Exchange Rights [Member]. Facility fee. Facility fee percentage on principal. fair value of detachable warrants, net. Element represents financing warrant. January 2017 [Member] Marketing Agreement [Member] Marketing fee payments due. Maximum royalty payable on sale of combined products. Medical Equipment [Member] Represents the percentage ownership sold during the period. MiniFAB [Member] Minimum percentage of purchase. Non-statutory stock type options. Ocu Hub Business Unit [Member] OcuHub Platform Technology [Member] Officer Director Or Consultant [Member] Represents operating loss carryforwards related to stock option exercises. Patents And Trademarks [Member] Percentage of options exercisable at a rate. Percentage Of Ownership Exercisable Options Expire. Percentage of reduction in annual prepayment fee. Percentage of term loan prepayment fee rate. Placement Agent Warrants [Member] Prepaid Manufacturing Deposits Current, Prepaid Subscriptions Current. Prepaid Trade Shows Current. Prescriber List [Member] Represents reader equipment rental revenues. Rest of World [Member] Royalty description. Royalty payment, percentage. Schedule of Common and Preferred Shares [Table Text Block] Second Tranche [Member]. Series A Convertible Preferred Stock [Member] Series A Warrants [Member] 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. The employees maximum payroll percentage deduction allowable towards the purchase of common stock under the Employee Stock Purchase Plan. State [Member] Name of share-based compensation plan. Supply Agreement [Member] Tear Lab Technology [Member] Term Loan Agreement [Member] Term Loan [Member]. Term loan minimum annual revenue threshold. 2014 Agreement [Member] 2006 Agreement [Member] 2003 Agreement [Member] 2018 [Member] 2019 [Member] 2017 [Member] 2020 [Member] Two Thousand Eleven Warrants [Member]. United States [Member] Warrants exercisable date. Warrants term. April 3, 2017 [Member] Amortization of intangible assets1. Purchase Commitment Remaining Minimum Amount. TermLoanAgreementMember Preferred Stock [Member] Assets, Current Assets Liabilities, Current Liabilities Stockholders' Equity Attributable to Parent Liabilities and Equity Revenues Gross Profit Operating Expenses Operating Income (Loss) Nonoperating Income (Expense) AmortizationOfIntangibleAssets1 Increase (Decrease) in Accounts Receivable Increase (Decrease) in Inventories Increase (Decrease) in Prepaid Expense and Other Assets Increase (Decrease) in Other Noncurrent 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 FacilityFee Debt Issuance Costs, Current, Net Long-term Debt 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 in Fourth Year Contractual Obligation, Due in Fifth Year Contractual Obligation EX-101.PRE 11 tear-20170331_pre.xml XBRL PRESENTATION FILE XML 12 R1.htm IDEA: XBRL DOCUMENT v3.7.0.1
Document and Entity Information - shares
3 Months Ended
Mar. 31, 2017
May 08, 2017
Document And Entity Information    
Entity Registrant Name TearLab Corp  
Entity Central Index Key 0001299139  
Document Type 10-Q  
Document Period End Date Mar. 31, 2017  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity Filer Category Smaller Reporting Company  
Entity Common Stock, Shares Outstanding   5,735,732
Trading Symbol TEAR  
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2017  
XML 13 R2.htm IDEA: XBRL DOCUMENT v3.7.0.1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Mar. 31, 2017
Dec. 31, 2016
Current assets    
Cash $ 13,032 $ 15,471
Accounts receivable, net 2,266 2,279
Inventory 3,324 3,193
Prepaid expenses and other current assets 1,216 1,226
Total current assets 19,838 22,169
Fixed assets, net 3,880 4,178
Intangible assets, net 44 60
Other non-current assets 220 220
Total assets 23,982 26,627
Current liabilities    
Accounts payable 2,745 1,858
Accrued liabilities 4,082 3,958
Deferred rent 70 83
Total current liabilities 6,897 5,899
Long-term debt 26,906 26,449
Total liabilities 33,803 32,348
Stockholders’ deficit    
Preferred Stock, $0.001 par value, 10,000,000 authorized, 757 and 2,764 issued and outstanding at March 31, 2017 and December 31, 2016, respectively
Common stock, $0.001 par value, 9,500,000 authorized, 5,634,756 and 5,360,198 issued and outstanding at March 31, 2017 and December 31, 2016, respectively 6 5
Additional paid-in capital 507,302 506,982
Accumulated deficit (517,129) (512,708)
Total stockholders’ deficit (9,821) (5,721)
Total liabilities and stockholders’ deficit $ 23,982 $ 26,627
XML 14 R3.htm IDEA: XBRL DOCUMENT v3.7.0.1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
Mar. 31, 2017
Dec. 31, 2016
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 outstanding 757 2,764
Preferred stock, shares issued 757 2,764
Common stock, par value $ 0.001 $ 0.001
Common stock, shares authorized 9,500,000 9,500,000
Common stock, shares issued 5,634,756 5,360,198
Common stock, shares outstanding 5,634,756 5,360,198
XML 15 R4.htm IDEA: XBRL DOCUMENT v3.7.0.1
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2017
Mar. 31, 2016
Revenue    
Product sales $ 5,987 $ 5,502
Reader equipment rentals 714 1,265
Total revenue 6,701 6,767
Cost of goods sold    
Cost of goods sold  (excluding amortization of intangible assets) 2,542 2,540
Cost of goods sold - reader equipment depreciation 466 554
Gross profit 3,693 3,673
Operating expenses    
Sales and marketing 3,332 4,636
Clinical, regulatory and research & development 1,564 1,138
General and administrative 2,187 3,931
Amortization of intangible assets 304
Total operating expenses 7,083 10,009
Loss from operations (3,390) (6,336)
Other income (expense)    
Interest income (expense) (1,028) (883)
Changes in fair value of warrant obligations 27
Other, net (3) (62)
Total other income (expense) (1,031) (918)
Net loss and comprehensive loss $ (4,421) $ (7,254)
Weighted average shares outstanding  - basic and fully diluted 5,367,311 3,382,567
Net loss per share $ (0.82) [1] $ (2.14)
Weighted average shares outstanding  - diluted 5,367,311 [1] 3,382,567
Net loss per share  – diluted $ (0.82) [1] $ (2.14)
[1] Restated for a 1-for-10 reverse stock split effected February 27, 2017.
XML 16 R5.htm IDEA: XBRL DOCUMENT v3.7.0.1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2017
Mar. 31, 2016
OPERATING ACTIVITIES    
Net loss for the period $ (4,421) $ (7,254)
Adjustments to reconcile net loss to cash used in operating activities:    
Stock-based compensation 289 714
Depreciation of fixed assets 521 620
Amortization of intangible assets 15 315
Changes in fair value of warrant obligations (27)
Deferred interest on long-term debt 302 292
Amortization of debt discount 154 43
Changes in operating assets and liabilities:    
Accounts receivable, net 13 (5)
Inventory (131) 338
Prepaid expenses and other assets 10 (475)
Other non-current assets (32)
Accounts payable 889 721
Accrued liabilities 123 (1,385)
Deferred rent/revenue (12) (3)
Cash used in operating activities (2,248) (6,138)
INVESTING ACTIVITIES    
Additions to fixed assets, net of proceeds (223) (500)
Cash used in investing activities (223) (500)
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 (2,439) (6,638)
Cash, beginning of period 15,471 13,838
Cash, end of period 13,032 7,200
Supplemental cash flow information    
Cash paid for interest $ 571 $ 552
XML 17 R6.htm IDEA: XBRL DOCUMENT v3.7.0.1
Basis of Presentation
3 Months Ended
Mar. 31, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Basis of Presentation

1. BASIS OF PRESENTATION

 

Nature of Operations

 

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

 

The accompanying condensed consolidated financial statements include the accounts of the Company and all of its wholly owned subsidiaries. On April 8, 2016, OcuHub Holdings, Inc., a wholly-owned subsidiary of the Company, completed the sale of 10,167.5 units of OcuHub LLC (“OcuHub”), reducing OcuHub Holdings, Inc.’s ownership in OcuHub to 10.5% on a fully-diluted basis. Prior to the sale, the accounts of OcuHub were included in the condensed consolidated financial statements. Intercompany accounts and transactions have been eliminated on consolidation.

 

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

 

Liquidity and Going Concern

 

The accompanying 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 $4,421 and $7,254 for the three months ended March 31, 2017 and 2016, respectively. Based on the Company’s current rate of cash consumption, the Company estimates it will need additional capital in the first quarter of 2018 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 2018 without violating an existing covenant on the Term Loan Agreement (defined below). As a result of the Company’s historical losses and financial condition, there is substantial doubt about the Company’s ability to continue as a going concern.

XML 18 R7.htm IDEA: XBRL DOCUMENT v3.7.0.1
Significant Accounting Policies
3 Months Ended
Mar. 31, 2017
Accounting Policies [Abstract]  
Significant Accounting Policies

2. SIGNIFICANT ACCOUNTING POLICIES

 

The consolidated balance sheet at December 31, 2016 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, 2016. The audited financial statements for the year ended December 31, 2016, filed with the SEC with the Company’s annual report on Form 10-K on March 10, 2017 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 normally 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

 

Revenue is recognized when all four of the following criteria are met: (i) persuasive evidence that an arrangement exists; (ii) delivery of the products has occurred; (iii) the selling price is fixed or determinable; and (iv) collectability is reasonably assured. The Company records revenue when all of its obligations are completed, which is generally upon shipment of the Company’s products. Amounts received in excess of revenue recognizable are deferred.

 

The Company sells its proprietary TearLab® Osmolarity System and related test cards to external customers, who are primarily eye care professionals, for use in osmolarity testing procedures. Revenue is primarily derived from the sale of disposable test cards. Products are generally shipped from a distribution and warehousing facility located in San Diego, California. The Company’s sales are currently direct to customers in the United States and 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 with sales of multiple deliverables, such as the reader equipment and disposable test cards (referred to as “Purchase Agreements”).

 

Purchase commitments for Use Agreements and Flex Agreements are expressed in the agreement for a specified period of time (generally one to three years). The purchase commitment for Masters Agreements is implied for large physician practices with an expectation of purchasing certain levels of test cards. The Company recovers the cost of providing the reader equipment in the amount charged for disposable test cards. These agreements are treated as operating leases as collectability of the minimum lease payments is not reasonably predictable at the outset of the arrangement. Accordingly, revenue is recognized over the defined contract term as disposable test cards are shipped. Revenue under such agreements is allocated between the lease of the reader equipment and the sale of the disposables based upon each component’s relative fair value. When reader equipment is placed with a customer at no separate cost, the Company retains title to the equipment and it remains capitalized on the Company’s 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.

 

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

 

Although the Company typically has a no return policy for its products, the Company has established a reserve for product sales that contain an implicit right of return. The Company reserves for estimated returns or refunds by reducing revenues at the time of shipment based on historical experience. The reserve of $11 and $13 as of March 31, 2017 and December 31, 2016, respectively, has reduced revenue and is included in accounts receivable.

 

Recent accounting pronouncements

 

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

 

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

 

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

 

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

XML 19 R8.htm IDEA: XBRL DOCUMENT v3.7.0.1
Balance Sheet Details
3 Months Ended
Mar. 31, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Balance Sheet Details

3. BALANCE SHEET DETAILS

 

Accounts receivable

 

    March 31, 2017     December 31, 2016  
             
Trade receivables   $ 2,810     $ 2,928  
                 
Allowance for doubtful accounts     (544 )     (649 )
    $ 2,266     $ 2,279  

 

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, 2017     December 31, 2016  
             
Finished goods   $ 3,341     $ 3,210  
Inventory reserves     (17 )     (17 )
    $ 3,324     $ 3,193  

 

The Company evaluates inventory for estimated excess quantities and obsolescence, based on expected future sales levels and projections of future demand, and establishes inventory reserves for obsolete and excess inventories. In addition, the Company assesses the impact of changing technology and market conditions. The Company has entered into a long 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, 2017     December 31, 2016  
Prepaid trade shows     253     $ 217  
Prepaid insurance     278       326  
Manufacturing deposits     282       282  
Subscriptions     299       297  
Other fees and services     96       66  
Other current assets     8       38  
    $ 1,216     $ 1,226  

 

Fixed assets

 

    March 31, 2017     December 31, 2016  
Capitalized TearLab equipment   $ 9,013     $ 9,095  
Leasehold improvements     60       60  
Computer equipment and software     920       932  
Furniture and office equipment     272       271  
Medical equipment     747       500  
    $ 11,012     $ 10,858  
Less accumulated depreciation     (7,132 )     (6,680 )
    $ 3,880     $ 4,178  

 

Depreciation expense was $521 and $620 during the three months ended March 31, 2017 and 2016, respectively.

 

Accrued liabilities

 

    March 31, 2017     December 31, 2016  
Due to professionals   $ 118     $ 81  
Due to employees and directors     2,175       2,200  
Sales and use tax liabilities     225       247  
Royalty liability     402       854  
Warranty     123       124  
Other     1,039       452  
    $ 4,082     $ 3,958  

XML 20 R9.htm IDEA: XBRL DOCUMENT v3.7.0.1
Intangible Assets
3 Months Ended
Mar. 31, 2017
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, was fully amortized in November 2016. Amortization expense for the three months ended March 31, 2017 and 2016 was $15 and $315, respectively.

 

Intangible assets subject to amortization consist of the following:

 

    Remaining                  
    Useful Life   Gross Value at     Accumulated     Net Book Value at  
    (Years)   March 31, 2017     Amortization     March 31, 2017  
                       
TearLab® technology   0   $ 12,172     $ (12,172 )   $ -  
Patents and trademarks   1     271       (249 )     22  
Prescriber list   1     90       (68 )     22  
Total       $ 12,533     $ (12,489 )   $ 44  

 

    Gross Value at     Accumulated     Net Book Value at  
    December 31, 2016     Amortization     December 2016  
                   
TearLab® technology   $ 12,172     $ (12,172 )   $ -  
Patents and trademarks     271       (245 )     26  
Prescriber list     90       (56 )     34  
Total   $ 12,533     $ (12,473 )   $ 60  

 

The estimated amortization expense for the intangible assets for the remainder of 2017 and thereafter is as follows:

 

    Amortization  
    of intangible  
    assets  
       
Remainder of 2017   $ 44  
    $ 44  

XML 21 R10.htm IDEA: XBRL DOCUMENT v3.7.0.1
Term Loan
3 Months Ended
Mar. 31, 2017
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 March 31, 2021 and bears interest at 13% per annum, with quarterly payments of interest only for the first four years. While interest on the loan is accrued at 13% per annum, the Company may elect to make interest-only payments at 8.5% per annum. The unpaid interest of 4.5% is added to the principal of the loan and is subject to additional accrued interest (“PIK interest”). The accrued interest can be deferred and paid together with the principal in the fifth and sixth years.

 

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 Consolidated Balance Sheets as of March 31, 2017 and 2016. The CRG Warrants were valued at their issuance date using the Black-Scholes Merton model. The related reduction of the long-term debt will be amortized over the life of the debt.

 

The loan is collateralized by all assets of the Company. Additionally, the terms of the Term Loan Agreement contain various affirmative and negative covenants agreed to by the Company. Among them, the Company must attain minimum certain annual revenue and minimum cash threshold levels. On April 7, 2016, the Company amended the Term Loan Agreement to change the required minimum revenue levels. The amended minimum revenue is $31,000 for 2017, $36,000 for 2018, $45,000 for 2019 and $55,000 for 2020. The minimum cash balance required is $5,000 subject to certain conditions. The amendment also reduced the exercise price of the CRG Warrants from $50.00 per share to $15.00 per share and the Company issued CRG additional warrants to purchase 35,000 common shares of the Company’s stock at $15.00 per share, which expire 5 years after issuance.

 

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, 2017, the Company was in compliance with all of the covenants.

 

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

 

The Company incurred financing and legal fees associated with the debt of $606, which were recorded as a direct discount to the debt and are being amortized using the effective interest method. The Company presents the debt issuance costs related to the recognized debt liability on the 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, 2017 and related maturities of outstanding principal:

 

Prinicpal balance outstanding   $ 25,000  
PIK interest     2,179  
Facility fee     428  
less discount on term loan:        
deferred financing fees, net     (404 )
detachable warrants, net     (297 )
Total term loan   $ 26,906  

 

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

 

2017     -  
2018     -  
2019     10,192  
2020     13,590  
2021     3,825  
Total principal due     27,607  
Less: discount on term loan     (701 )
Total term loan   $ 26,906  

XML 22 R11.htm IDEA: XBRL DOCUMENT v3.7.0.1
Stockholders' Equity
3 Months Ended
Mar. 31, 2017
Equity [Abstract]  
Stockholders' Equity

6. STOCKHOLDERS’ EQUITY

 

(a) Authorized share capital

 

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

 

On June 24, 2016, the Company’s stockholders approved an amendment to the Company’s certificate of incorporation to increase the total number of authorized shares of common stock of the Company to 9,500,000 from 6,500,000. Each share of common stock has a par value of $0.001 per share. The total number of authorized shares of preferred stock of the Company is 10,000,000. Each share of preferred stock has a par value of $0.001 per share.

 

(b) Common and preferred shares

 

On May 9, 2016 the Company issued 1,861,090 shares of common stock, 3,291.8 shares of Series A Convertible Preferred Stock (“Preferred Stock”) and Series A warrants to purchase 1,150,000 shares of common stock (“Series A Warrants”) for gross proceeds of $17,250, less issuance costs of $1,793. Additionally, the Company granted the placement agent warrants to purchase 103,500 shares of common stock with an exercise price of $11.25 per share. The Preferred Stock is convertible, subject to certain limitations, into an aggregate of 438,910 shares of common stock, contains no voting rights, participates in any common stock dividends, and is treated as if converted upon any ordinary liquidation event. The common stock, the Series A Convertible Preferred Stock, and the Series A Warrants are all included in equity in the Company’s Consolidated Balance Sheets as of December 31, 2016. The net proceeds were allocated to common stock, Preferred Stock, and Series A Warrants based on their relative fair values, as follows:

 

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

 

On August 2, 2016, 527.5 shares of Series A Convertible Preferred stock was converted into 70,333 shares of common stock. On March 31, 2017, 2,007 shares of Series A Convertible Preferred stock was converted into 267,600 shares of Common stock. On April 3, 2017, subsequent to the March 31, 2017 balance sheet date, the remaining 757 shares of Series A Convertible Preferred stock were converted into 100,976 shares of common stock.

 

(c) Stock Incentive Plan

 

The Company has a stock incentive plan, the 2002 Stock Incentive Plan (the “Stock Incentive Plan”), under which up to 720,000 options are available for grant to employees, directors and consultants. Options 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.

 

The Company accounts for stock-based compensation awards and share-based payment transactions with employees based on the fair value of the award at the time of grant and recognizes 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,  
    2017     2016  
             
Sales and marketing   $ 146     $ 136  
Clinical, regulatory and research and development     43       83  
General and administrative     100       495  
Stock-based compensation expense before income taxes   $ 289     $ 714  

 

(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 67,150 shares of the Company’s common stock are reserved for issuance under the plan, which permits eligible employees to purchase common stock at a discount through payroll deductions.

 

The price at which stock is purchased under the ESPP is equal to 90% of the fair market value of the common stock on the first or the last day of the offering period, whichever is lower. Generally, each offering under the ESPP will be for a period of six months as determined by the Company’s Board of Directors. Employees may invest up to 20% of their gross compensation through payroll deductions. In no event may an employee 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, 2017 and 2016, the Company recorded $3 of expense, respectively, under the ESPP. During the three months ended March 31, 2017 and 2016, the Company issued 7,512 and 6,774 shares of common stock under the ESPP, respectively.

 

(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 Consolidated Balance Sheets as of March 31, 2017 and December 31, 2016. The CRG Warrants were valued at $290 upon issuance using the Black-Scholes Merton model assuming volatility of 73%, an expected life of 5.0 years, a risk-free interest rate of 1.71%, and 0% dividend yield. No CRG Warrants were exercised during the three months ended March 31, 2017 or 2016.

 

On April 8, 2016, the Company further amended its Term Loan Agreement. As part of the amendment, the exercise price of the CRG Warrants was changed to allow the holder to purchase 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.

 

(f) Exchange Right

 

In August 2014, the Company sold membership units in OcuHub in exchange for 2% ownership of OcuHub LLC. In connection with the sale of the membership units, the new members received an exchange right allowing the units to be exchanged upon written notice and during a specified exchange window for shares in the Company’s common stock. On March 31, 2016, the members exchanged the ownership interest in OcuHub LLC for 385,800 shares of the Company’s common stock.

XML 23 R12.htm IDEA: XBRL DOCUMENT v3.7.0.1
Net Income (Loss) Per Share
3 Months Ended
Mar. 31, 2017
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:

 

    Three Months Ended  
(in thousands of shares)   March 31,  
    2017     2016  
Stock options     706       638  
Warrants     1,324       64  
ESPP shares     3       8  
Convertible preferred shares     102       -  
                 
Total     2,135       710  

XML 24 R13.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments and Contingencies
3 Months Ended
Mar. 31, 2017
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 June 30, 2018. The Company leases office facilities under an operating lease agreement. The initial term of the lease is five years and includes periodic rent increases and a renewal option.

 

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

 

Future minimum royalty payments under this agreement as of March 31, 2017 are as follows:

 

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

 

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

 

Future minimum royalty payments under this agreement as of March 31, 2017 are as follows:

 

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

 

On March 7, 2016, the Company, through its subsidiary, TearLab Research, Inc., entered into a supply and development agreement (“Supply Agreement”) with MiniFAB (Aust) Pty Ltd (“MiniFAB”). The agreement is an exclusive supply agreement through June 2021, 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 July 2011 agreement between MiniFAB and the Company.

 

In April 2014, the Company guaranteed a marketing agreement entered into by OcuHub. The underlying marketing agreement calls for an annual marketing fee of $100, with payments due quarterly through March 31, 2019. If OcuHub fails to perform its obligations under the terms of the marketing agreement, the Company would be required to make the $25 quarterly payments, through the March 31, 2019 initial term of the agreement. The Company has not accrued for any liability under the guarantee.

 

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

 

Contingencies

 

During the ordinary course of business activities, the Company may be contingently liable for litigation and a party to claims. Currently the Company is not party to any litigation.

XML 25 R14.htm IDEA: XBRL DOCUMENT v3.7.0.1
Significant Accounting Policies (Policies)
3 Months Ended
Mar. 31, 2017
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

 

Revenue is recognized when all four of the following criteria are met: (i) persuasive evidence that an arrangement exists; (ii) delivery of the products has occurred; (iii) the selling price is fixed or determinable; and (iv) collectability is reasonably assured. The Company records revenue when all of its obligations are completed, which is generally upon shipment of the Company’s products. Amounts received in excess of revenue recognizable are deferred.

 

The Company sells its proprietary TearLab® Osmolarity System and related test cards to external customers, who are primarily eye care professionals, for use in osmolarity testing procedures. Revenue is primarily derived from the sale of disposable test cards. Products are generally shipped from a distribution and warehousing facility located in San Diego, California. The Company’s sales are currently direct to customers in the United States and 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 with sales of multiple deliverables, such as the reader equipment and disposable test cards (referred to as “Purchase Agreements”).

 

Purchase commitments for Use Agreements and Flex Agreements are expressed in the agreement for a specified period of time (generally one to three years). The purchase commitment for Masters Agreements is implied for large physician practices with an expectation of purchasing certain levels of test cards. The Company recovers the cost of providing the reader equipment in the amount charged for disposable test cards. These agreements are treated as operating leases as collectability of the minimum lease payments is not reasonably predictable at the outset of the arrangement. Accordingly, revenue is recognized over the defined contract term as disposable test cards are shipped. Revenue under such agreements is allocated between the lease of the reader equipment and the sale of the disposables based upon each component’s relative fair value. When reader equipment is placed with a customer at no separate cost, the Company retains title to the equipment and it remains capitalized on the Company’s 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.

 

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

 

Although the Company typically has a no return policy for its products, the Company has established a reserve for product sales that contain an implicit right of return. The Company reserves for estimated returns or refunds by reducing revenues at the time of shipment based on historical experience. The reserve of $11 and $13 as of March 31, 2017 and December 31, 2016, respectively, has reduced revenue and is included in accounts receivable.

Recent Accounting Pronouncements

Recent accounting pronouncements

 

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

 

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

 

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

 

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

XML 26 R15.htm IDEA: XBRL DOCUMENT v3.7.0.1
Balance Sheet Details (Tables)
3 Months Ended
Mar. 31, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Schedule of Accounts Receivable

    March 31, 2017     December 31, 2016  
             
Trade receivables   $ 2,810     $ 2,928  
                 
Allowance for doubtful accounts     (544 )     (649 )
    $ 2,266     $ 2,279  

Schedule of Inventory

    March 31, 2017     December 31, 2016  
             
Finished goods   $ 3,341     $ 3,210  
Inventory reserves     (17 )     (17 )
    $ 3,324     $ 3,193  

Summary of Prepaid Expenses and Other Current Assets

    March 31, 2017     December 31, 2016  
Prepaid trade shows     253     $ 217  
Prepaid insurance     278       326  
Manufacturing deposits     282       282  
Subscriptions     299       297  
Other fees and services     96       66  
Other current assets     8       38  
    $ 1,216     $ 1,226  

Schedule of Fixed Assets

    March 31, 2017     December 31, 2016  
Capitalized TearLab equipment   $ 9,013     $ 9,095  
Leasehold improvements     60       60  
Computer equipment and software     920       932  
Furniture and office equipment     272       271  
Medical equipment     747       500  
    $ 11,012     $ 10,858  
Less accumulated depreciation     (7,132 )     (6,680 )
    $ 3,880     $ 4,178  

Schedule of Accrued Liabilities

    March 31, 2017     December 31, 2016  
Due to professionals   $ 118     $ 81  
Due to employees and directors     2,175       2,200  
Sales and use tax liabilities     225       247  
Royalty liability     402       854  
Warranty     123       124  
Other     1,039       452  
    $ 4,082     $ 3,958  

XML 27 R16.htm IDEA: XBRL DOCUMENT v3.7.0.1
Intangible Assets (Tables)
3 Months Ended
Mar. 31, 2017
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, 2017     Amortization     March 31, 2017  
                       
TearLab® technology   0   $ 12,172     $ (12,172 )   $ -  
Patents and trademarks   1     271       (249 )     22  
Prescriber list   1     90       (68 )     22  
Total       $ 12,533     $ (12,489 )   $ 44  

 

    Gross Value at     Accumulated     Net Book Value at  
    December 31, 2016     Amortization     December 2016  
                   
TearLab® technology   $ 12,172     $ (12,172 )   $ -  
Patents and trademarks     271       (245 )     26  
Prescriber list     90       (56 )     34  
Total   $ 12,533     $ (12,473 )   $ 60  

Schedule of Estimated Amortization Expense of Intangible Assets

The estimated amortization expense for the intangible assets for the remainder of 2017 and thereafter is as follows:

 

    Amortization  
    of intangible  
    assets  
       
Remainder of 2017   $ 44  
    $ 44  

XML 28 R17.htm IDEA: XBRL DOCUMENT v3.7.0.1
Term Loan (Tables)
3 Months Ended
Mar. 31, 2017
Debt Disclosure [Abstract]  
Schedule of Term Loan

The following is a summary of the Term Loan Agreement as of March 31, 2017 and related maturities of outstanding principal:

 

Prinicpal balance outstanding   $ 25,000  
PIK interest     2,179  
Facility fee     428  
less discount on term loan:        
deferred financing fees, net     (404 )
detachable warrants, net     (297 )
Total term loan   $ 26,906  

Schedule of Maturities of Outstanding Principal of Term Loan

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

 

2017     -  
2018     -  
2019     10,192  
2020     13,590  
2021     3,825  
Total principal due     27,607  
Less: discount on term loan     (701 )
Total term loan   $ 26,906  

XML 29 R18.htm IDEA: XBRL DOCUMENT v3.7.0.1
Stockholders' Equity (Tables)
3 Months Ended
Mar. 31, 2017
Equity [Abstract]  
Schedule of Common and Preferred Shares

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

 

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

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,  
    2017     2016  
             
Sales and marketing   $ 146     $ 136  
Clinical, regulatory and research and development     43       83  
General and administrative     100       495  
Stock-based compensation expense before income taxes   $ 289     $ 714  

XML 30 R19.htm IDEA: XBRL DOCUMENT v3.7.0.1
Net Income (Loss) Per Share (Tables)
3 Months Ended
Mar. 31, 2017
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:

 

    Three Months Ended  
(in thousands of shares)   March 31,  
    2017     2016  
Stock options     706       638  
Warrants     1,324       64  
ESPP shares     3       8  
Convertible preferred shares     102       -  
                 
Total     2,135       710  

XML 31 R20.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments and Contingencies (Tables)
3 Months Ended
Mar. 31, 2017
2006 Agreement [Member]  
Schedule of Future Minimum Payments

Future minimum royalty payments under this agreement as of March 31, 2017 are as follows:

 

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

2003 Agreement [Member]  
Schedule of Future Minimum Payments

Future minimum royalty payments under this agreement as of March 31, 2017 are as follows:

 

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

XML 32 R21.htm IDEA: XBRL DOCUMENT v3.7.0.1
Basis of Presentation (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended
Feb. 27, 2017
Apr. 08, 2016
Mar. 31, 2017
Mar. 31, 2016
Reserve stock split 1-for-10 reverse stock split      
Net income (loss)     $ 4,421 $ 7,254
OcuHub Business Inc [Member]        
Owned subsidiary, in units   10,167.5    
Ownership percentage   10.50%    
XML 33 R22.htm IDEA: XBRL DOCUMENT v3.7.0.1
Significant Accounting Policies (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended 12 Months Ended
Mar. 31, 2017
Dec. 31, 2016
Accounting Policies [Abstract]    
Reserve of product sales $ 11 $ 13
XML 34 R23.htm IDEA: XBRL DOCUMENT v3.7.0.1
Balance Sheet Details (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2017
Mar. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Depreciation expense $ 521 $ 620
XML 35 R24.htm IDEA: XBRL DOCUMENT v3.7.0.1
Balance Sheet Details - Schedule of Accounts Receivable (Details) - USD ($)
$ in Thousands
Mar. 31, 2017
Dec. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Trade receivables $ 2,810 $ 2,928
Allowance for doubtful accounts (544) (649)
Accounts receivable net $ 2,266 $ 2,279
XML 36 R25.htm IDEA: XBRL DOCUMENT v3.7.0.1
Balance Sheet Details - Schedule of Inventory (Details) - USD ($)
$ in Thousands
Mar. 31, 2017
Dec. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Finished goods $ 3,341 $ 3,210
Inventory reserves (17) (17)
Inventory net $ 3,324 $ 3,193
XML 37 R26.htm IDEA: XBRL DOCUMENT v3.7.0.1
Balance Sheet Details - Summary of Prepaid Expenses and Other Current Assets (Details) - USD ($)
$ in Thousands
Mar. 31, 2017
Dec. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Prepaid trade shows $ 253 $ 217
Prepaid insurance 278 326
Manufacturing deposits 282 282
Subscriptions 299 297
Other fees and services 96 66
Other current assets 8 38
Prepaid expense and other current assets $ 1,216 $ 1,226
XML 38 R27.htm IDEA: XBRL DOCUMENT v3.7.0.1
Balance Sheet Details - Schedule of Fixed Assets (Details) - USD ($)
$ in Thousands
Mar. 31, 2017
Dec. 31, 2016
Property plant and equipment, gross $ 11,012 $ 10,858
Less accumulated depreciation (7,132) (6,680)
Property plant and equipment net 3,880 4,178
Capitalized TearLab Equipment [Member]    
Property plant and equipment, gross 9,013 9,095
Leasehold Improvements [Member]    
Property plant and equipment, gross 60 60
Computer Equipment and Software [Member]    
Property plant and equipment, gross 920 932
Furniture and Office Equipment [Member]    
Property plant and equipment, gross 272 271
Medical Equipment [Member]    
Property plant and equipment, gross $ 747 $ 500
XML 39 R28.htm IDEA: XBRL DOCUMENT v3.7.0.1
Balance Sheet Details - Schedule of Accrued Liabilities (Details) - USD ($)
$ in Thousands
Mar. 31, 2017
Dec. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Due to professionals $ 118 $ 81
Due to employees and directors 2,175 2,200
Sales and use tax liabilities 225 247
Royalty liability 402 854
Warranty 123 124
Other 1,039 452
Accrued liabilities current $ 4,082 $ 3,958
XML 40 R29.htm IDEA: XBRL DOCUMENT v3.7.0.1
Intangible Assets (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2017
Mar. 31, 2016
Goodwill and Intangible Assets Disclosure [Abstract]    
Amortization expense $ 15 $ 315
XML 41 R30.htm IDEA: XBRL DOCUMENT v3.7.0.1
Intangible Assets - Schedule of Amortization of Intangible Assets (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2017
Dec. 31, 2016
Gross Value $ 12,533 $ 12,533
Accumulated Amortization (12,489) (12,473)
Net Book Value $ 44 60
TearLab Technology [Member]    
Remaining Useful Life (Years) 0 years  
Gross Value $ 12,172 12,172
Accumulated Amortization (12,172) (12,172)
Net Book Value
Patents and Trademarks [Member]    
Remaining Useful Life (Years) 1 year  
Gross Value $ 271 271
Accumulated Amortization (249) (245)
Net Book Value $ 22 26
Prescriber List [Member]    
Remaining Useful Life (Years) 1 year  
Gross Value $ 90 90
Accumulated Amortization (68) (56)
Net Book Value $ 22 $ 34
XML 42 R31.htm IDEA: XBRL DOCUMENT v3.7.0.1
Intangible Assets - Schedule of Estimated Amortization Expense for Intangible Assets (Details) - Indefinite-lived Intangible Assets [Member]
$ in Thousands
Mar. 31, 2017
USD ($)
Remainder of 2017 $ 44
Total $ 44
XML 43 R32.htm IDEA: XBRL DOCUMENT v3.7.0.1
Term Loan (Details Narrative) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended
Oct. 06, 2015
Mar. 04, 2015
Mar. 31, 2017
Dec. 31, 2016
Apr. 08, 2016
Long-term debt     $ 26,906 $ 26,449  
Term Loan Agreement [Member] | CRG LP Additional Warrants [Member]          
Warrants to purchase common shares     35,000   35,000
Warrants exercise price     $ 15.00   $ 15.00
Term Loan Agreement [Member] | CRG LP Additional Warrants [Member] | Minimum [Member]          
Warrants exercise price     50.00    
Term Loan Agreement [Member] | CRG LP Additional Warrants [Member] | Maximum [Member]          
Warrants exercise price     $ 15.00    
Black-Scholes Merton Model [Member] | Term Loan Agreement [Member] | CRG LP Additional Warrants [Member]          
Warrants term     5 years    
Term Loan Agreement [Member]          
Minimum cash balance     $ 5,000    
Term Loan Agreement [Member] | CRG LP [Member]          
Long-term debt   $ 35,000      
Proceeds from issuance of long-term debt   $ 15,000      
Debt instrument date   Mar. 31, 2021      
Debt instrument interest rate percentage   13.00%      
Warrants to purchase common shares 35,000        
Warrants exercise price $ 50.00        
Warrants term     5 years    
Financing and legal fees to long-term debt     $ 606    
Facility fee percentage on principal     6.50%    
Percentage of prepayment fee     5.00%    
Percentage of reduction in annual prepayment fee     1.00%    
Term Loan Agreement [Member] | CRG LP [Member] | 2017 [Member]          
Term loan minimum annual revenue threshold     $ 31,000    
Term Loan Agreement [Member] | CRG LP [Member] | 2018 [Member]          
Term loan minimum annual revenue threshold     36,000    
Term Loan Agreement [Member] | CRG LP [Member] | 2019 [Member]          
Term loan minimum annual revenue threshold     45,000    
Term Loan Agreement [Member] | CRG LP [Member] | 2020 [Member]          
Term loan minimum annual revenue threshold     $ 55,000    
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 44 R33.htm IDEA: XBRL DOCUMENT v3.7.0.1
Term Loan - Schedule of Term Loan (Details) - USD ($)
$ in Thousands
Mar. 31, 2017
Dec. 31, 2016
Debt Disclosure [Abstract]    
Principle balance outstanding $ 25,000  
PIK interest 2,179  
Facility fee 428  
Deferred financing fees, net (404)  
Fair value of detachable warrants, net (297)  
Total term loan $ 26,906 $ 26,449
XML 45 R34.htm IDEA: XBRL DOCUMENT v3.7.0.1
Term Loan - Schedule of Maturities of Outstanding Principal of Term Loan (Details) - USD ($)
$ in Thousands
Mar. 31, 2017
Dec. 31, 2016
Debt Disclosure [Abstract]    
2017  
2018  
2019 10,192  
2020 13,590  
2021 3,825  
Total principal due 27,607  
Less: discount on term loan (701)  
Total term loan $ 26,906 $ 26,449
XML 46 R35.htm IDEA: XBRL DOCUMENT v3.7.0.1
Stockholders' Equity (Details Narrative) - USD ($)
$ / shares in Units, $ in Thousands
1 Months Ended 3 Months Ended
Feb. 27, 2017
Aug. 02, 2016
May 09, 2016
Apr. 08, 2016
Oct. 08, 2015
Mar. 31, 2016
Aug. 31, 2014
Mar. 31, 2017
Mar. 31, 2016
Dec. 31, 2016
Jun. 24, 2016
Reserve stock split 1-for-10 reverse stock split                    
Common stock shares authorized               9,500,000   9,500,000 9,500,000
Common stock shares authorized previously                     6,500,000
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     1,861,090                
Preferred stock, issued               757   2,764  
Proceeds from issuance or sale of equity               $ 15,457      
Allocated share-based compensation expense               $ 289 $ 714    
Term Loan Agreement [Member] | Tranche One [Member]                      
Proceeds from issuance of long-term debt         $ 10,000            
OcuHub Business Inc [Member]                      
Stock issued during period, shares new issue           385,800          
Membership unit percentage             2.00%        
Stock Incentive Plan [Member]                      
Share-based compensation expiration period               10 years      
Percentage of ownership exercisable options expire               10.00%      
Weighted-average fair value of stock options granted               $ 4.30      
Expected weighted-average period               6 years      
Stock Incentive Plan [Member] | Maximum [Member]                      
Share-based compensation common stock purchase price percentage               110.00%      
Stock Incentive Plan [Member] | Maximum [Member] | Officer Director Or Consultant [Member]                      
Percentage of options exercisable at a rate               20.00%      
Stock Incentive Plan [Member] | Minimum [Member]                      
Share-based compensation common stock purchase price percentage               10.00%      
Stock Incentive Plan [Member] | Non-Statutory Stock Options [Member] | Maximum [Member]                      
Share-based compensation common stock purchase price percentage               85.00%      
Stock Incentive Plan [Member] | Employees, Directors and Consultants [Member]                      
Share-based compensation number of shares available for grant               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               67,150      
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               $ 3 $ 3    
Stock issued during period number of shares of employee stock purchase plans               7,512 6,774    
Series A Convertible Preferred Stock [Member]                      
Number of preferred stock converted into common stock   527.5                  
Number of preferred stock converted into common stock, shares   70,333           2,007      
Series A Convertible Preferred Stock [Member] | April 3, 2017 [Member]                      
Number of preferred stock converted into common stock, shares               757      
Common Stock [Member]                      
Proceeds from issuance or sale of equity               $ 9,632      
Number of preferred stock converted into common stock, shares               267,600      
Common Stock [Member] | April 3, 2017 [Member]                      
Number of preferred stock converted into common stock, shares               100,976      
Series A Convertible Preferred Stock [Member]                      
Preferred stock, issued     3,291.8                
Series A Warrants [Member]                      
Preferred stock, issued     1,150,000                
Proceeds from issuance or sale of equity     $ 17,250                
Payments of stock issuance costs     $ 1,793                
Series A Warrants [Member] | Black-Scholes Merton Model [Member]                      
Common stock par value     $ 11.25                
Stock issued during period, shares new issue     1,253,500                
Fair value assumptions expected volatility rate     76.00%                
Fair value assumptions expected term     6 years                
Fair value assumptions risk free interest rate     1.30%                
Fair value assumptions dividend yield     0.00%                
Placement Agent Warrants [Member]                      
Preferred stock, issued     103,500                
Share issued price per share     $ 11.25                
Common Stock [Member]                      
Common stock, conversion basis     438,910                
CRG Warrants [Member]                      
Common stock par value       $ 15.00              
Stock issued during period, shares new issue       35,000              
Class of warrant or right number of securities called by warrants or rights         35,000            
Class of warrant or right exercise price of warrants or rights         $ 50.00            
Fair value of warrants         $ 290            
Warrants exercisable date         Oct. 08, 2020            
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] | Term Loan Agreement [Member] | Black-Scholes Merton Model [Member]                      
Fair value of warrants                 $ 106    
Fair value assumptions expected volatility rate                 76.00%    
Fair value assumptions expected term                 5 years    
Fair value assumptions risk free interest rate                 1.30%    
Fair value assumptions dividend yield                 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       $ 15.00       $ 15.00      
CRG LP Additional Warrants [Member] | Term Loan Agreement [Member] | Black-Scholes Merton Model [Member]                      
Fair value of warrants               $ 54      
Fair value assumptions expected volatility rate               76.00%      
Fair value assumptions expected term               4 years 6 months      
Fair value assumptions risk free interest rate               1.06%      
Fair value assumptions dividend yield               0.00%      
CRG LP Additional Warrants [Member] | Term Loan Agreement [Member] | Maximum [Member]                      
Class of warrant or right exercise price of warrants or rights               $ 15.00      
CRG LP Additional Warrants [Member] | Term Loan Agreement [Member] | Minimum [Member]                      
Class of warrant or right exercise price of warrants or rights               $ 50.00      
XML 47 R36.htm IDEA: XBRL DOCUMENT v3.7.0.1
Stockholders' Equity - Schedule of Common and Preferred Shares (Details)
$ in Thousands
3 Months Ended
Mar. 31, 2017
USD ($)
Proceeds from issuance or sale of equity $ 15,457
Common Stock [Member]  
Proceeds from issuance or sale of equity 9,632
Series A Convertible Preferred Stock [Member]  
Proceeds from issuance or sale of equity 2,275
Series A Warrants [Member]  
Proceeds from issuance or sale of equity $ 3,550
XML 48 R37.htm IDEA: XBRL DOCUMENT v3.7.0.1
Stockholders' Equity - Schedule of Stock-Based Compensation Expense (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2017
Mar. 31, 2016
Stock-based compensation expense before income taxes $ 289 $ 714
Sales and Marketing [Member]    
Stock-based compensation expense before income taxes 146 83
Clinical, Regulatory and Research and Development [Member]    
Stock-based compensation expense before income taxes 43 495
General and Administrative [Member]    
Stock-based compensation expense before income taxes $ 100 $ 136
XML 49 R38.htm IDEA: XBRL DOCUMENT v3.7.0.1
Net Income (Loss) Per Share - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares
3 Months Ended
Mar. 31, 2017
Mar. 31, 2016
Antidilutive securities number of shares 2,135,000 710,000
Stock Options [Member]    
Antidilutive securities number of shares 706,000 638,000
Warrants [Member]    
Antidilutive securities number of shares 1,324,000 64,000
ESPP Shares [Member]    
Antidilutive securities number of shares 3,000 8,000
Convertible Preferred Shares [Member]    
Antidilutive securities number of shares 102,000
XML 50 R39.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments and Contingencies (Details Narrative) - USD ($)
$ in Thousands
1 Months Ended 3 Months Ended
Mar. 07, 2016
Mar. 12, 2003
Apr. 30, 2014
Mar. 31, 2017
Apr. 30, 2016
Lease expiration date       Jun. 30, 2018  
Royalty payments   $ 35   $ 35  
Royalty payment, percentage   5.50%   5.50%  
Royalty description       The Company is required to pay a royalty of 30% of any sublicense fees it receives prior to receiving FDA approval and 25% of any sub-license fees it receives after FDA approval.  
Maximum royalty payable on sale of combined products   5.50%      
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%        
Marketing Agreement [Member] | OcuHub Business Inc [Member]          
Marketing fee payments due     Mar. 31, 2019    
Annual marketing fee     $ 100    
Marketing agreement, quarterly payments         $ 25
XML 51 R40.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments and Contingencies - Schedule of Future Minimum Payments (Details)
$ in Thousands
Mar. 31, 2017
USD ($)
2006 Agreement [Member]  
2017 $ 35
2018 35
2019 35
2020 35
2021 35
Thereafter 210
Total 385
2003 Agreement [Member]  
2017 35
2018 35
2019 35
2020 35
2021 35
Thereafter 210
Total $ 385
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