NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. Organization and Basis of Presentation
GenMark Diagnostics, Inc., the Company or GenMark, was formed by Osmetech plc as a Delaware corporation in February 2010, and had no operations prior to its initial public offering, which was completed in June 2010. The Company is a leading provider of automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP, and applicable regulations of the U.S. Securities and Exchange Commission, or the SEC, and should be read in conjunction with the audited financial statements included in the Company's Annual Report on Form 10-K for the fiscal year ended
December 31, 2016
filed with the SEC on
February 28, 2017
. These unaudited condensed consolidated financial statements reflect all adjustments that are, in the opinion of management, necessary for a fair statement of the results for the interim periods presented. These adjustments are of a normal, recurring nature. Interim period operating results may not be indicative of the operating results for the full year or any future period.
During the quarter ended March 31, 2017, the Company adopted Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic 205-40, Presentation of Financial Statements - Going Concern, which requires that management evaluate whether there are relevant conditions and events that in the aggregate raise substantial doubt about the entity’s ability to continue as a going concern and to meet its obligations as they become due within
one
year after the date that the financial statements are issued. Under this standard, management’s assessment may not take into consideration the potential mitigating effects of management’s plans that have not been fully implemented as of the date the financial statements are issued. The Company has experienced net losses and negative cash flows from operating activities since its inception. As of
March 31, 2017
, the Company had an accumulated deficit of
$369,188,000
and working capital of $
21,060,000
available to fund future operations. Because the Company continues to incur net losses, its transition to profitability depends on the successful development, approval, and commercialization of its future products and achieving a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until it does, the Company would need to raise additional capital.
In performing the first step of the assessment under ASC Topic 205-40, the Company considered that its future operations anticipate the clearance by the U.S. Food and Drug Administration, or the FDA, of its ePlex Respiratory Pathogen (RP) Panel, which will allow the Company to draw
$15,000,000
on its existing credit facility. The Company also continues to consider alternative forms of financing, including equity financing. However, there can be no assurances that the Company will be able draw on the credit facility or that sources of capital will be available on terms acceptable to the Company, or at all. Without the financing or capital described above, and without consideration of management’s other plans to control costs, continued net losses as anticipated raise substantial doubt about the Company’s ability to continue as a going concern under the first step of the assessment.
In performing the second step of this assessment, the Company is required to evaluate whether it has other plans to mitigate the conditions to alleviate the substantial doubt about its ability to meet its obligations as they become due. In performing this step, management considered the
$15,000,000
in funding available under its credit facility since management believes the FDA clearance milestone is probable of being achieved. Management has also developed a plan to implement cost reduction measures to reduce its working capital requirements, assuming additional funding from the credit facility is unavailable. The plan includes a delay in capital expenditures, a delay in hiring and additional reductions in personnel-related costs, the curtailment of certain of the Company’s development activities and other discretionary expenditures that are within the Company’s control. Any of the actions contemplated by the implementation of this plan, if required, could have an adverse impact on the Company’s ability to achieve certain of its planned objectives during 2017, and thus, materially harm the Company’s business.
Management has concluded that if required, implementing these measures will allow the Company to meet its obligations as they become due within
one
year after the date that the financial statements are issued.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the notes thereto. The Company’s significant estimates included in the preparation of the financial statements are related to accounts receivable, inventories, property and equipment, intangible assets, employee-related compensation accruals, warranty liabilities, tax valuation accounts and stock-based compensation. Actual results could differ from those estimates.
Segment Information
The Company currently operates in
one
reportable business segment, which encompasses the development, manufacturing, sales and support of instruments and molecular tests based on its proprietary eSensor® detection technology. Substantially all of the Company’s operations and assets are in the United States of America.
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by FASB or other standard setting bodies that the Company adopts as of the specified effective date.
In March 2016, the FASB issued Accounting Standards Update, or ASU, 2016-09,
Improvements to Employee Share-Based Payment Accounting
. The guidance simplifies how several aspects of share-based payments are accounted for and presented in the financial statements and is effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The Company's adoption of this guidance in the first quarter of 2017 resulted in excess tax benefits for which a benefit could not be previously recognized of approximately
$1,979,000
. Upon adoption, the balance of the unrecognized excess tax benefits was reversed with the impact recorded to retained earnings, including a corresponding change to the valuation allowance. Due to the full valuation allowance on the Company's U.S. deferred tax assets, there was no impact to the financial statements as a result of this adoption. The Company continues to record stock-based compensation expense net of estimated forfeitures.
In February 2016, the FASB issued ASU 2016-02,
Leases
. This ASU outlines a comprehensive lease accounting model and supersedes the current lease guidance. The new guidance requires lessees to recognize lease liabilities and corresponding right-of-use assets for all leases with lease terms of greater than 12 months. It also changes the definition of a lease and expands the disclosure requirements of lease arrangements. The new guidance must be adopted using the modified retrospective approach and will be effective for the Company starting in the first quarter of fiscal 2019, with early adoption permitted. The Company is evaluating the effects adoption will have on its consolidated financial statements, but does not anticipate a material impact on its financial statements.
In May 2014, the FASB issued ASU 2014-09,
Revenue from Contracts with Customers,
an updated standard on revenue recognition. ASU 2014-09 provides enhancements to the quality and consistency of how revenue is reported by companies while also improving comparability in the financial statements of companies reporting using International Financial Reporting Standards or U.S. GAAP. The main purpose of the new standard is for companies to recognize revenue to depict the transfer of goods or services to customers in amounts that reflect the consideration to which a company expects to be entitled in exchange for those goods or services. The new standard also will result in enhanced disclosures of revenue, provide guidance for transactions that were not previously addressed comprehensively, and improve guidance for multiple-element arrangements. In August 2015, the FASB issued ASU No. 2015-14,
Revenue from Contracts with Customers: Deferral of the Effective Date
, which deferred the effective date of the new revenue standard for periods beginning after December 15, 2016 to December l5, 2017, with early adoption permitted but not earlier than the original effective date. Accordingly, the updated standard is effective for the Company in the first quarter of fiscal 2018. The Company is evaluating the impact of implementation and its transition approach of this standard on its financial statements.
Cash, Cash Equivalents and Marketable Securities
Cash and cash equivalents consist of cash on deposit with banks, money market instruments and certificates of deposit with original maturities of three months or less at the date of purchase. Marketable securities consist of certificates of deposits that mature in greater than three months. Marketable securities are accounted for as "available-for-sale" with the carrying amounts reported in the balance sheets stated at cost, which approximates their fair market value, with unrealized gains and losses, if any, reported as a separate component of stockholders' equity and included in comprehensive loss.
Restricted Cash
Restricted cash represents amounts designated for uses other than current operations and included
$758,000
as of
March 31, 2017
, held as security for the Company’s letter of credit with Banc of California.
Receivables
Accounts receivable consist of amounts due to the Company for sales to customers and are recorded net of an allowance for doubtful accounts. The allowance for doubtful accounts is determined based on an assessment of the collectability of specific customer accounts, the aging of accounts receivable, and a reserve for unknown items based upon the Company’s historical experience.
Product Warranties
The Company generally offers a
one
-year warranty for its instruments sold to customers and typically up to a
60
day warranty for consumables. Factors that affect the Company’s warranty reserves include the number of units sold, historical and anticipated rates of warranty repairs, and the cost per repair. The Company periodically assesses the adequacy of its warranty reserve and adjusts the amount as appropriate.
Intangible Assets
Intangible assets are comprised of licenses or sublicenses to technology covered by patents owned by third parties, and are amortized on a straight-line basis over the expected useful lives of these assets, which is generally
10 years
. Amortization of licenses typically begins upon the Company obtaining access to the licensed technology and is recorded in cost of revenues for licenses supporting commercialized products. The amortization of licenses to technology supporting products in development is recorded in research and development expenses.
Impairment of Long-Lived Assets
The Company assesses the recoverability of long-lived assets, including intangible assets, by periodically evaluating the carrying value whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. If impairment is indicated, the Company writes down the carrying value of the asset to its estimated fair value. This fair value is primarily determined based on estimated discounted cash flows.
Inventories
Inventories are stated at the lower of cost (first-in, first-out) or net realizable value and include direct labor, materials, and manufacturing overhead. The Company periodically reviews inventory for evidence of slow-moving or obsolete parts, and writes inventory down to net realizable value, as needed. This write down is based on management’s review of inventories on hand, compared to estimated future usage and sales, shelf-life assumptions, and assumptions about the likelihood of obsolescence. If actual market conditions are less favorable than those projected by the Company, additional inventory write-downs may be required. Inventory impairment charges establish a new cost basis for inventory and charges are not reversed subsequently to income, even if circumstances later suggest that increased carrying amounts are recoverable.
Property and Equipment, net
Property, equipment and leasehold improvements are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets, which are identified below. Repair and maintenance costs are expensed as incurred.
|
|
|
Machinery and laboratory equipment
|
3 - 5 years
|
Instruments
|
4 - 5 years
|
Office equipment
|
3 - 7 years
|
Leasehold improvements
|
over the shorter of the remaining life of the lease or the useful economic life of the asset
|
Income Taxes
Current income tax expense is the amount of income taxes expected to be payable for the current year. A deferred income tax liability or asset is established for the expected future tax consequences resulting from the differences in financial reporting and tax bases of assets and liabilities. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax assets will not be realized. A full valuation allowance has been recorded against the Company’s net deferred tax assets due to the uncertainty surrounding the Company’s ability to utilize these assets in the future. The Company provides for uncertain tax positions when such tax positions do not meet the recognition thresholds or measurement standards prescribed by the authoritative guidance on income taxes. Amounts for uncertain tax positions are adjusted in periods when new information becomes available or when positions are effectively settled. The Company recognizes accrued interest related to uncertain tax positions as a component of income tax expense.
A tax position that is more likely than not to be realized is measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon settlement with the taxing authority that has full knowledge of all relevant information. Measurement of a tax position that meets the more likely than not threshold considers the amounts and probabilities of the outcomes that could be realized upon settlement using the facts, circumstances and information available at the reporting date.
2. Stock-Based Compensation
The Company recognizes stock-based compensation expense related to stock options, restricted stock awards, restricted stock units, and market-based stock units granted to employees and directors in exchange for services under the Company's 2010 Equity Incentive Plan, or the 2010 Plan, and employee stock purchases under the Company's 2013 Employee Stock Purchase Plan, or the ESPP. Employee participation in the 2010 Plan is at the discretion of the Compensation Committee of the Board of Directors of the Company. Each equity award grant reduces the number of shares available for grant under the 2010 Plan. Stock-based compensation expense is based on the fair value of the applicable award utilizing various assumptions regarding the underlying attributes of the award. The estimated fair value, net of forfeitures expected to occur during the vesting period, is amortized as compensation expense on a straight-line basis to reflect vesting as it occurs. Stock-based compensation expense is recorded in cost of sales, sales and marketing, research and development, and/or general and administrative expenses based on the employee's respective function. During the
three
months ended
March 31, 2017
and
2016
, aggregate stock-based compensation expense was
$2,808,000
and
$2,402,000
, respectively.
The fair value of stock options granted is derived from the Black-Scholes Option Pricing Model, which uses several judgment-based variables to calculate the expense. The inputs include the expected term of the stock option, the expected volatility and other factors.
•
Expected Term.
Expected term represents the period that the stock-based awards are expected to be outstanding and is determined by using the simplified method.
•
Expected Volatility
. Expected volatility represents the estimated volatility in the Company’s stock price over the expected term of the stock option and is determined by review of the Company’s and similar companies’ historical experience.
•
Expected Dividend
. The Black-Scholes Option Pricing Model calls for a single expected dividend yield as an input. The Company has assumed no dividends as it has never paid dividends and has no current plans to do so.
•
Risk-Free Interest Rate.
The risk-free interest rate used in the Black-Scholes Option Pricing Model is based on published U.S. Treasury rates in effect at the time of grant for periods corresponding with the expected term of the option.
All stock options granted under the 2010 Plan are exercisable at a per share price equal to the closing quoted market price of a share of the Company’s common stock on the NASDAQ Global Market on the grant date and generally vest over a period of between
one
and
four years
. Stock options are generally exercisable for a period of up to
10 years
after grant and are typically forfeited if employment is terminated before the options vest.
The following table summarizes stock option activity during the
three
months ended
March 31, 2017
:
|
|
|
|
|
|
|
|
|
Number of
Shares
|
|
Weighted Average Exercise Price
|
Outstanding at December 31, 2016
|
2,569,550
|
|
|
$
|
9.53
|
|
Granted
|
—
|
|
|
—
|
|
Exercised
|
(16,471)
|
|
|
5.33
|
|
Cancelled
|
(3,258)
|
|
|
11.94
|
|
Outstanding at March 31, 2017
|
2,549,821
|
|
|
9.56
|
|
Vested and expected to vest at March 31, 2017
|
2,490,813
|
|
|
9.50
|
|
Exercisable at March 31, 2017
|
2,016,369
|
|
|
$
|
8.93
|
|
Options that were exercisable as of
March 31, 2017
had a remaining weighted average contractual term of
5.52
years, and an aggregate intrinsic value of
$7,949,000
. As of
March 31, 2017
, there were
2,549,821
stock options outstanding, which had a remaining weighted average contractual term of
5.97
years and an aggregate intrinsic value of
$8,525,000
. No stock options were granted during the
three
months ended
March 31, 2017
.
Restricted stock awards or units may be granted in connection with the hiring or retention of personnel and are subject to certain conditions. In March 2013, the Company transitioned to granting restricted stock units under the 2010 Plan in lieu of granting restricted stock awards. The compensation expense related to the restricted stock awards or units is calculated as the fair market value of the stock on the grant date and is adjusted for estimated forfeitures. The Company’s restricted stock award and restricted stock unit activity for the
three
months ended
March 31, 2017
was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted Stock Awards
|
|
Restricted Stock Units
|
|
Number of
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
|
Number of
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
Unvested at December 31, 2016
|
156
|
|
|
$
|
11.19
|
|
|
1,766,123
|
|
|
$
|
7.18
|
|
Granted
|
—
|
|
|
—
|
|
|
1,028,884
|
|
|
10.68
|
|
Vested
|
(156)
|
|
|
11.19
|
|
|
(320,081)
|
|
|
6.00
|
|
Cancelled
|
—
|
|
|
—
|
|
|
(20,766)
|
|
|
8.47
|
|
Unvested at March 31, 2017
|
—
|
|
|
$
|
—
|
|
|
2,454,160
|
|
|
$
|
8.79
|
|
As of
March 31, 2017
, all compensation expenses related to restricted stock awards has been recognized. The total fair value of restricted stock awards that vested during the
three
months ended
March 31, 2017
and
2016
was
$2,000
and
$110,000
, respectively.
As of
March 31, 2017
, there was
$15,162,000
of unrecognized compensation cost related to unvested restricted stock units, which is expected to be recognized over a weighted average period of
3.12
years. The total fair value of restricted stock units that vested during the
three
months ended
March 31, 2017
and
2016
was $
1,920,000
and
$2,250,000
, respectively.
The Company issued market-based stock units in February 2017 and February 2016, which may result in the recipient receiving shares of stock equal to
200%
of the target number of units granted. The vesting and issuance of Company stock depends on the Company's stock performance as compared to the NASDAQ Composite Index over a three-year period following the grant and continued service with the Company. As of
March 31, 2017
, there was
$1,932,000
of unrecognized stock-based compensation expense related to these awards, which is expected to be recognized over a weighted average period of
2.11
years. The Company’s market-based stock unit activity for the
three
months ended
March 31, 2017
was as follows:
|
|
|
|
|
|
|
|
|
Market-Based Stock Units
|
|
Number of
Shares
|
|
Weighted
Average
Grant Date
Fair Value
|
Unvested at December 31, 2016
|
222,773
|
|
|
$
|
7.34
|
|
Target units granted
|
243,561
|
|
|
13.82
|
|
Vested
|
—
|
|
|
—
|
|
Cancelled
|
—
|
|
|
—
|
|
Unvested at March 31, 2017
|
466,334
|
|
|
$
|
10.53
|
|
The fair value of these market-based stock units was estimated on the date of grant using the Monte Carlo Simulation Valuation Model, which estimates the potential outcome of achieving the market condition based on simulated future stock prices, with the following assumptions for the
three
months ended
March 31, 2017
:
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
March 31,
|
|
2017
|
|
2016
|
Expected volatility
|
54
|
%
|
|
49
|
%
|
Risk-free interest rate
|
1.50
|
%
|
|
0.90
|
%
|
Expected dividend
|
—
|
%
|
|
—
|
%
|
Weighted average fair value
|
$
|
13.82
|
|
|
$
|
4.94
|
|
The Company issued
43,200
performance-based restricted stock units in March 2014 with a grant date fair value of
$12.30
per share. The vesting and issuance of Company stock pursuant to these awards depends on obtaining regulatory clearance of various products within a defined time. Stock-based compensation expense for performance-based awards is recognized when it is probable that the applicable performance criteria will be satisfied. The probability of achieving the relevant performance criteria is evaluated on a quarterly basis. As of
March 31, 2017
, there was
$133,000
of unrecognized stock-based compensation expense related to these awards.
Employee Stock Purchase Plan
The Company's stockholders approved the ESPP in May 2013. A total of
650,000
shares of the Company’s common stock were originally reserved for issuance under the ESPP, 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
85%
of the fair market value of the Company's 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; provided that no offering period may exceed
27
months. Employees may invest up to
10%
of their qualifying gross compensation through payroll deductions. In no event may an employee purchase more than
1,500
shares of common stock during any six-month offering period. As of
March 31, 2017
, there were
267,839
shares of common stock available for issuance under the ESPP. The ESPP is a compensatory plan as defined by the authoritative guidance for stock compensation; therefore, stock-based compensation expense related to the ESPP has been recorded during the
three
months ended
March 31, 2017
.
3. Net Loss per Common Share
Basic net loss per share is calculated by dividing loss available to stockholders of the Company's common stock (the numerator) by the weighted average number of shares of the Company's common stock outstanding during the period (the denominator). Shares issued during the period and shares reacquired during the period are weighted for the portion of the period that they were outstanding. Diluted loss per share is calculated in a similar way to basic loss per share except that the denominator is increased to include the number of additional shares that would have been outstanding if the dilutive potential shares had been issued, unless the effect would be anti-dilutive.
The computations of diluted net loss per share for the
three
month periods ended
March 31, 2017
and
2016
did not include the effects of the following stock options and other equity awards which were outstanding as of the end of each period because the inclusion of these securities would have been anti-dilutive (in thousands):
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2017
|
|
2016
|
Options outstanding to purchase common stock
|
2,550
|
|
2,875
|
Other unvested equity awards
|
2,931
|
|
2,390
|
Total
|
5,481
|
|
5,265
|
4. Inventories
Inventory on hand as of
March 31, 2017
and
December 31, 2016
comprised the following (in thousands):
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
December 31, 2016
|
Raw materials
|
$
|
2,589
|
|
|
$
|
2,171
|
|
Work-in-process
|
2,929
|
|
|
1,488
|
|
Finished goods
|
3,501
|
|
|
2,974
|
|
Total inventories
|
$
|
9,019
|
|
|
$
|
6,633
|
|
5. Property and Equipment, net
Property and equipment as of
March 31, 2017
and
December 31, 2016
comprised the following (in thousands):
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
December 31, 2016
|
Property and equipment — at cost:
|
|
|
|
Machinery and laboratory equipment
|
$
|
10,245
|
|
|
$
|
10,145
|
|
Instruments
|
10,662
|
|
|
9,869
|
|
Office equipment
|
1,742
|
|
|
1,714
|
|
Leasehold improvements
|
10,318
|
|
|
10,100
|
|
Total property and equipment — at cost
|
32,967
|
|
|
31,828
|
|
Less: accumulated depreciation
|
(14,485
|
)
|
|
(13,560
|
)
|
Property and equipment, net
|
$
|
18,482
|
|
|
$
|
18,268
|
|
Depreciation expense was
$1,093,006
and
$806,000
for the three months ended
March 31, 2017
and
2016
, respectively.
6. Intangible Assets, net
Intangible assets as of
March 31, 2017
and
December 31, 2016
comprised the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
December 31, 2016
|
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net Carrying Amount
|
|
Gross Carrying Amount
|
|
Accumulated Amortization
|
|
Net Carrying Amount
|
Licensed intellectual property
|
$
|
4,250
|
|
|
$
|
(1,704
|
)
|
|
$
|
2,546
|
|
|
$
|
4,250
|
|
|
$
|
(1,580
|
)
|
|
$
|
2,670
|
|
Intellectual property licenses have a weighted average remaining amortization period of
5.15
years as of
March 31, 2017
. Amortization expense for these licenses was
$124,000
and
$94,000
for the three months ended
March 31, 2017
and
2016
, respectively. Estimated future amortization expense for these licenses is as follows (in thousands):
|
|
|
|
|
|
Fiscal Years Ending
|
|
Future Amortization Expense
|
Remaining in 2017
|
|
$
|
373
|
|
2018
|
|
497
|
|
2019
|
|
497
|
|
2020
|
|
497
|
|
2021
|
|
497
|
|
Thereafter
|
|
185
|
|
Total
|
|
$
|
2,546
|
|
7. Loan Payable
As of
March 31, 2017
and
December 31, 2016
, long-term debt consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
December 31, 2016
|
Term Loans
|
|
|
|
|
Term Loan A - 6.9% principal
|
|
$
|
10,000
|
|
|
$
|
10,000
|
|
Term Loan B - 6.9% principal
|
|
10,000
|
|
|
10,000
|
|
Final fee obligation
|
|
878
|
|
|
400
|
|
Unamortized issuance costs
|
|
(932
|
)
|
|
(585
|
)
|
Total debt, net
|
|
19,946
|
|
|
19,815
|
|
Current portion of long-term debt
|
|
(7,685
|
)
|
|
(7,935
|
)
|
Long-term debt
|
|
$
|
12,261
|
|
|
$
|
11,880
|
|
Term Loans
In January 2015, the Company entered into a Loan and Security Agreement, or the LSA, with Solar Capital Partners (as successor-in-interest to General Electric Capital Corporation), and certain other financial institutions party thereto, as lenders, pursuant to which the Company obtained (a) up to
$35,000,000
in a series of term loans and (b) a revolving loan in the maximum amount of
$5,000,000
. Under the terms of the LSA, the Company may, subject to certain conditions, borrow:
•
$10,000,000
on or before March 31, 2015, or Term Loan A;
• an additional
$10,000,000
, or Term Loan B, subject to the Company’s satisfaction of regulatory requirements necessary to CE Mark its ePlex system in Europe by a specified date; and
• an additional
$15,000,000
, or Term Loan C, and together with Term Loan A and Term Loan B, the Term Loans, subject to the Company’s satisfaction of FDA 510(k) market clearance for the sale of the Company’s ePlex system in the United States by a specified date.
On March 27, 2015, the Company borrowed
$10,000,000
pursuant to Term Loan A. The Term Loans will accrue interest at a rate equal to, (
a) the greater of 1.00% or the 3-year treasury rate in effect at the time of funding, plus (b) an applicable margin between 4.95% and 5.90% per annum.
The Company is only required to make interest payments on amounts borrowed pursuant to the Term Loans from the applicable funding date until
March 1, 2017
or the Interest Only Period. Following the Interest Only Period, monthly installments of principal and interest under the Term Loans will be due until the original principal amount and applicable interest is fully repaid by
January 12, 2019
, or the Maturity Date.
On September 30, 2015, the Company entered into a first amendment to the LSA, pursuant to which the lenders internally reallocated certain funding commitments under the LSA between the lenders (but did not increase or reduce the aggregate amount of such commitments), and the parties adjusted certain of the Company’s administrative financial reporting obligations and the dates by which certain future funding requirements must be satisfied.
In March 2016, the Company entered into an additional amendment to the LSA, pursuant to which the parties adjusted the date by which the Company must satisfy the funding requirements in respect of Term Loan B.
In June 2016, the Company borrowed an additional
$10,000,000
pursuant to Term Loan B following the satisfaction of regulatory requirements necessary to CE Mark the Company’s ePlex system in Europe.
In July 2016, the Company entered into an additional amendment to the LSA pursuant to which the lenders reallocated certain funding commitments under the LSA between the lenders, and the parties extended the date by which the future funding requirements in respect of Term Loan C must be satisfied.
In February 2017, the Company entered into an additional amendment to the LSA with Solar Capital Partners and certain other financial institutions party thereto, as lenders, pursuant to which the parties extended the date by which the future funding requirements in respect of Term Loan C must be satisfied. In addition, the parties agreed to extend the Interest-Only Period in respect of amounts already borrowed under Term Loan A and Term Loan B, and the amount, if any, borrowed pursuant to Term Loan C, until June 1, 2017. The parties also agreed that the Company has the option to further extend the Interest-Only Period until August 1, 2017, and subsequently to March 1, 2018, subject in each case to the satisfaction of certain conditions.
Under the LSA, the Company is required to comply with certain affirmative and negative covenants, including, without limitation, delivering reports and notices relating to the Company’s financial condition and certain regulatory events and intellectual property matters, as well as limiting the creation of liens, the incurrence of indebtedness, and the making of certain investments, dividends, payments and acquisitions, other than as specifically permitted by the LSA. As of
March 31, 2017
, the Company was in compliance with all covenants under the LSA.
Revolving Loan
Pursuant to the LSA, the Company may borrow up to
$5,000,000
under a revolving loan facility. Borrowings under the revolving loan will accrue interest at a rate equal to (a)
the greater of 1.25% per annum or a base rate as determined by a three-month LIBOR-based formula, plus (b) an applicable margin between 2.95% and 3.95%
based on certain criteria as set forth in the LSA. All principal and interest outstanding under the revolving loan is due and payable on the Maturity Date. Following the funding of Term Loan A, the Company is required to pay a commitment fee equal to
0.75%
per annum of the amounts made available but unborrowed under the revolving loan. As of
March 31, 2017
, the Company had not borrowed any amounts pursuant the revolving loan facility.
Debt Issuance Costs
As of
March 31, 2017
and
December 31, 2016
, the Company had
$932,000
and
$585,000
, respectively, of unamortized debt issuance discount, which is offset against borrowings in long-term and short-term debt.
For the three months ended
March 31, 2017
and 2016, amortization of debt issuance costs was
$151,000
and
$92,000
, respectively. Amortization of debt issuance costs is included in interest expense in the Company's unaudited condensed consolidated statements of comprehensive loss for the periods presented.
Letter of Credit
In September 2012, the Company provided a
$758,000
letter of credit issued by Banc of California to the landlord of its executive office facility in Carlsbad, California. This letter of credit was secured with
$758,000
of restricted cash as of
March 31, 2017
.
8. Leases
The Company has operating and capital lease agreements for its office, manufacturing, warehousing and laboratory space and for office equipment. Rent and operating expenses charged under these arrangements was
$409,000
and
$387,000
for the three months ended
March 31, 2017
and
2016
, respectively. Pursuant to the Company's lease agreements, a portion of the monthly rent has been deferred. The balance of deferred rent as of
March 31, 2017
and
December 31, 2016
was
$4,005,000
and
$4,097,000
, respectively.
As of
March 31, 2017
, the future minimum lease payments required over the next five years under the Company's lease arrangements are as follows (in thousands):
|
|
|
|
|
|
Fiscal Years Ending
|
|
Future Minimum Lease Payments
|
Remaining in 2017
|
|
$
|
1,252
|
|
2018
|
|
1,792
|
|
2019
|
|
1,913
|
|
2020
|
|
1,972
|
|
2021
|
|
1,372
|
|
Thereafter
|
|
1,366
|
|
Total
|
|
$
|
9,667
|
|
9. Fair Value of Financial Instruments
The carrying amounts of financial instruments, such as cash equivalents, restricted cash, accounts receivable, and accounts payable approximate the related fair values due to the short-term maturities of these instruments.
The Company uses a fair value hierarchy with three levels of inputs, of which the first two are considered observable and the last unobservable, to measure fair value:
• Level 1 — Quoted prices in active markets for identical assets or liabilities.
• Level 2 — Inputs, other than Level 1, that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
• Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The following table presents the financial instruments measured at fair value on a recurring basis and the valuation approach applied to each class of financial instruments as of
March 31, 2017
and
December 31, 2016
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Total
|
Money market funds (cash equivalents)
|
$
|
242
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
242
|
|
Corporate notes and bonds
|
—
|
|
|
9,007
|
|
|
—
|
|
|
9,007
|
|
U.S. government and agency securities
|
—
|
|
|
1,500
|
|
|
—
|
|
|
1,500
|
|
Commercial paper
|
—
|
|
|
500
|
|
|
—
|
|
|
500
|
|
Total
|
$
|
242
|
|
|
$
|
11,007
|
|
|
$
|
—
|
|
|
$
|
11,249
|
|
|
|
|
|
|
|
|
|
|
December 31, 2016
|
|
Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Total
|
Money market funds (cash equivalents)
|
$
|
556
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
556
|
|
Corporate notes and bonds
|
—
|
|
|
18,821
|
|
|
—
|
|
|
18,821
|
|
U.S. government and agency securities
|
—
|
|
|
3,503
|
|
|
—
|
|
|
3,503
|
|
Commercial paper
|
—
|
|
|
3,283
|
|
|
—
|
|
|
3,283
|
|
Total
|
$
|
556
|
|
|
$
|
25,607
|
|
|
$
|
—
|
|
|
$
|
26,163
|
|
Level 2 marketable securities are priced using quoted market prices for similar instruments or nonbinding market prices that are corroborated by observable market data. The Company uses inputs such as actual trade data, benchmark yields, broker/dealer quotes, and other similar data, which are obtained from quoted market prices, independent pricing vendors, or other sources, to determine the ultimate fair value of these assets and liabilities. The Company uses such pricing data as the primary input to make its assessments and determinations as to the ultimate valuation of its investment portfolio and has not made, during the periods presented, any material adjustments to such inputs.
10. Investments
The following table summarizes the Company’s marketable securities as of
March 31, 2017
and
December 31, 2016
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Estimated Fair Value
|
Corporate notes and bonds
|
|
$
|
9,017
|
|
|
$
|
—
|
|
|
$
|
(10
|
)
|
|
$
|
9,007
|
|
U.S. government and agency securities
|
|
1,502
|
|
|
—
|
|
|
(2
|
)
|
|
1,500
|
|
Commercial paper
|
|
500
|
|
|
—
|
|
|
—
|
|
|
500
|
|
Total
|
|
$
|
11,019
|
|
|
$
|
—
|
|
|
$
|
(12
|
)
|
|
$
|
11,007
|
|
|
|
|
|
|
|
|
|
|
December 31, 2016
|
|
Amortized Cost
|
|
Gross Unrealized Gains
|
|
Gross Unrealized Losses
|
|
Estimated Fair Value
|
Corporate notes and bonds
|
|
$
|
18,846
|
|
|
$
|
—
|
|
|
$
|
(25
|
)
|
|
$
|
18,821
|
|
U.S. government and agency securities
|
|
3,506
|
|
|
—
|
|
|
(3
|
)
|
|
3,503
|
|
Commercial paper
|
|
3,283
|
|
|
—
|
|
|
—
|
|
|
3,283
|
|
Total
|
|
$
|
25,635
|
|
|
$
|
—
|
|
|
$
|
(28
|
)
|
|
$
|
25,607
|
|
The following table summarizes the maturities of the Company’s marketable securities as of
March 31, 2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
Amortized Cost
|
|
Estimated Fair Value
|
Due in one year or less
|
$
|
11,019
|
|
|
$
|
11,007
|
|
Due after one year through two years
|
—
|
|
|
—
|
|
Total
|
$
|
11,019
|
|
|
$
|
11,007
|
|
11. Income Taxes
The Company uses an estimated annual effective tax rate, which is based on expected annual income, statutory tax rates and tax planning opportunities available in the various jurisdictions in which the Company operates, to determine its quarterly provision for income taxes. Certain significant or unusual items are separately recognized in the quarter in which they occur and can be a source of variability in the effective tax rates from quarter to quarter.
As of
March 31, 2017
, the Company recorded a full valuation allowance against all of its net deferred tax assets due to the uncertainty surrounding the Company’s ability to utilize these assets in the future. Due to the Company's losses, it only records a tax provision or benefit related to uncertain tax positions and related interest and minimum tax payments or refunds. The Company recorded income tax expense of
$1,000
for the three months ended
March 31, 2017
.
The Company is subject to taxation in the United States and in various state and foreign jurisdictions. The Company's federal and state returns since inception are subject to examination due to the carryover of net operating losses. As of
March 31, 2017
, the Company’s tax years from 2011 through 2012 are subject to examination by the United Kingdom tax authorities related to legacy operations. The statute of limitations for the assessment and collection of income taxes related to other foreign tax returns varies by country. In the foreign countries where we have operations, these time periods generally range from three to five years after the year for which the tax return is due or the tax is assessed.