NovoCure Ltd - Quarter Report: 2015 September (Form 10-Q)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

For the quarterly period ended September 30, 2015

or

For the transition period from                       to

Commission File Number 001-37565

NovoCure Limited

(Exact Name of Registrant as Specified in Its Charter)

Le Masurier House

La Rue Le Masurier

St. Helier, Jersey JE2 4YE

(Address of principal executive offices)

+44 (0) 15 3475 6700

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name, Former Address and Former Fiscal Year, If Changed Since Last Report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes o  No x.

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 o.

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

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

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

In addition to historical facts or statements of current condition, this report contains forward-looking statements 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. Forward-looking statements contained in this report are based on our current plans, expectations, hopes, beliefs, intentions or strategies concerning future developments and their impact on us.  Forward-looking statements contained in this report constitute our expectations or forecasts of future events as of the date this report was filed with the Securities and Exchange Commission and are not statements of historical fact. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Such statements may include words such as “anticipate,” “will,” “estimate,” “expect,” “project,” “intend,” “should,” “plan,” “believe,” “hope,” and other words and terms of similar meaning in connection with any discussion of, among other things, future operating or financial performance, strategic initiatives and business strategies, regulatory or competitive environments, our intellectual property and delivery system research and development. In particular, these forward-looking statements include, among others, statements about:

These forward-looking statements involve a number of risks and uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these factors are described in Part II, Item IA, Risk Factors, of this Quarterly Report on Form 10-Q.  We do not intend to update publicly any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

ii

NovoCure Limited

Quarterly Report on Form 10-Q

TABLE OF CONTENTS

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PART I—FINANCIAL INFORMATION

Item 1.  Financial Statements

NOVOCURE LIMITED AND SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

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

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NOVOCURE LIMITED AND SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands (except share data)

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

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NOVOCURE LIMITED AND SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF OPERATIONS

U.S. dollars in thousands (except share and per share data)

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

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NOVOCURE LIMITED AND SUBSIDIARIES

CONDENSED INTERIM STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

U.S. dollars in thousands (except share data)

*)      Net of issuance expenses of $319

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

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NOVOCURE LIMITED AND SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED CASH FLOWS

U.S. dollars in thousands (except share data)

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

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NOVOCURE LIMITED AND SUBSIDIARIES

Notes to Condensed Interim Consolidated Financial Statements (unaudited)

NOTE 1:- GENERAL

NovoCure Limited (including its consolidated subsidiaries, the “Company”) was incorporated in Jersey (Channel Islands) and is principally engaged in the development, manufacture and commercialization of tumor treating fields (“TTFields”) for the treatment of solid tumors. Since inception, the Company has devoted substantially all of its efforts to developing a family of products to deliver TTFields for a variety of solid tumor indications, raising capital and recruiting personnel. The Company commenced selling and marketing activities for Optune, its first approved delivery system, in the United States at the end of 2011, and began commercial launch in Europe during 2014 and in Japan during the second half of 2015.

NovoCure Limited wholly owns the following subsidiaries: Novocure Luxembourg Sarl (“Novocure Luxembourg”) and Novocure (Israel) Ltd. (“Ltd.”). Novocure Luxembourg wholly owns Novocure GmbH, NovoCure Limited’s Swiss subsidiary (“Novocure Switzerland”) and Novocure GmbH, the German subsidiary of NovoCure Limited (“Novocure Germany”). Novocure Switzerland wholly owns Novocure Inc. (“Inc.”), the U.S. subsidiary, and  Novocure KK, the Japanese subsidiary. Inc. wholly owns Novocure (USA) LLC.

The Company’s research and development activity is conducted by Ltd. and clinical trials are managed on behalf of the Company mainly by Ltd., Novocure Switzerland and Inc. Novocure KK markets TTFields and will conduct clinical trials in Japan. Inc. is marketing and selling TTFields in the United States Novocure Switzerland manages the global supply chain operations for the Company, manages clinical trials conducted outside the United States and Japan and manages the marketing of TTFields in Europe. Novocure Germany supports and markets TTFields in Germany.

In September 2015, the Company’s shareholders approved the restructuring of the Company’s share capital by converting the Company’s ordinary and preferred shares to no par value shares and by effecting a sub-division of the issued and outstanding share capital of the Company based on a proportion of 1:5.913 (“Share Split Ratio”).  Following this approval, each ordinary and preferred share, nominal value £0.01 per share, was divided into 5.913 shares of such applicable class of shares of the Company, each with no par value per share. The Split Ratio to the Company’s outstanding options and warrants, in accordance with their terms. All share information included in these consolidated financial statements has been retroactively adjusted to reflect the conversion to no par value shares and the Share Split Ratio.

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES

Significant accounting policies applied in the audited annual consolidated financial statements of the Company are applied consistently in these unaudited interim financial statements

a. Use of estimates:

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company evaluates on an ongoing basis its assumptions, including those related to contingencies, deferred taxes, tax liabilities, useful-life of field equipment and share-based compensation costs. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the consolidated financial statements, and the reported amounts of net revenue and expenses during the reporting period. Actual results could differ from those estimates.

b. Financial statements in U.S. dollars:

The accompanying financial statements have been prepared in U.S. dollars in thousands.

The Company finances its operations in U.S. dollars and a substantial portion of its costs and revenues from its primary markets is incurred in U.S. dollars. As such, the Company’s management believes that the dollar is the currency of the primary economic environment in which the Company operates. Thus, the functional and reporting currency of the Company is the U.S. dollar.

Transactions and balances denominated in U.S. dollars are presented at their original amounts. Monetary accounts maintained in currencies other than the dollar are re-measured into dollars in accordance with Accounting Standards Codification No. 830-10, “Foreign Currency Matters.” All transaction gains and losses of the re-measurement of monetary balance sheet items are reflected in the consolidated statements of operations as financial income or expenses, as appropriate.

c. Principles of consolidation:

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The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. Intercompany transactions and balances, including profits from intercompany sales not yet realized outside the Company, have been eliminated upon consolidation.

d. Cash equivalents:

Cash equivalents are short-term, highly liquid investments that are readily convertible into cash with an original maturity of three months or less at the date acquired.

e. Short-term investments and restricted cash:

1. Short-term investments:

The Company accounts for investments in debt securities in accordance with ASC 320, “Investments-Debt and Equity Securities.” Management determines the appropriate classification of its investments in marketable debt securities at the time of purchase and reevaluates such determinations at each balance sheet date. As of September 30, 2015, all securities are classified as held-to-maturity since the Company has the intent and ability to hold the securities to maturity and, accordingly, debt securities are stated at amortized cost.

The amortized cost of held-to-maturity securities is adjusted for amortization of premiums and accretion of discounts to maturity and any other than temporary impairment losses. Such amortization and interest are included in the consolidated statement of operations as financial income or expenses, as appropriate.

For the nine-months period ended September 30, 2014 and 2015 (unaudited), no other than temporary impairment losses have been identified.

2. The Company has restricted cash as of September 30, 2015 of $166 (unaudited) used as security to cover bank guarantees in respect of use of Company credit cards in the Swiss operations.

f. Inventories:

Inventories are stated at the lower of cost or market. Cost is determined using the weighted average method. The Company regularly evaluates the ability to realize the value of inventory. If actual demand for the Company’s delivery systems deteriorates, or market conditions are less favorable than those projected, inventory write-offs may be required.

There were no inventory write-offs for the nine-month periods ended September 30, 2014 and 2015 (unaudited).

g. Property and equipment:

Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets at the following rates:

h. Field equipment under operating leases:

Field equipment is stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful life of the field equipment which was determined to be two years. Field equipment consists of equipment being utilized under rental agreements accounted for in accordance with ASC 840 on a monthly basis as an operating lease, as well as “service pool” equipment. Service pool equipment is equipment owned and maintained by the Company that is swapped for equipment that needs repairs or maintenance by the Company while being rented by a patient. The Company records a provision for any excess, lost or damaged equipment when warranted based on an assessment of the equipment. Write-downs for equipment are included in cost of revenues. During the nine-month periods ended September 30, 2014 and 2015 (unaudited) $12 and $32, respectively, write-downs had been identified.

i. Impairment of long-lived assets:

The Company’s long-lived assets are reviewed for impairment in accordance with ASC 360-10, “Property, Plant and Equipment”, whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Recoverability of an asset to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted cash flows

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expected to be generated by the asset. If such asset is considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds its fair value. During the nine-month periods ended September 30, 2014 and 2015 (unaudited), no impairment losses have been identified.

j. Long-term lease deposits:

Long-term lease deposits in respect of office rent and vehicles under operating leases are presented in other long-term assets.

h. Revenue recognition:

The TTFields delivery system (“System”) for GBM, Optune, is comprised of two main components: (1) an Electric Field Generator (the “device”) and (2) Transducer Arrays and related accessories that are disposable supplies to the device (“disposables”). Title is retained by the Company for the device and the patient is provided replacement disposables for the device during the rental period. The device and disposables are always supplied and functioning together and are not sold on a standalone basis.

Revenues are recognized when persuasive evidence of an arrangement exists, delivery of the system has occurred, the price is fixed or determinable and collectability is reasonably assured. The evidence of an arrangement generally consists of a prescription, a patient service agreement and the verification of eligibility and insurance with the patient’s third-party insurance company (“payer”). The Company generally bills third-party payers a monthly fee for use of the System by patients. As such, the Company takes assignment of benefits and risk of collection from the third-party payer. Patients have out-of-pocket costs for the amount not covered by their payer and the Company bills the patient directly for the amounts of their co-pays and deductible, subject to the Company’s patient assistance programs.

For the reported periods, all revenues are recognized when cash is collected assuming that all other revenue recognition criteria have been met, as the price is not fixed or determinable and the collectability cannot be reasonably assured. The price is not fixed or determinable since the Company does not have sufficient history with payers to reliably estimate their individual payment patterns and as such cannot reliably estimate the amount that would be ultimately collected. Once sufficient history is established and the Company can reliably estimate the amounts that would be ultimately collected per payer/payer group and the above criteria are met, the Company will recognize revenues from the use of the System on an accrual basis ratably over the lease term.

Revenues are presented net of indirect taxes, which include excise tax of $752 and $1,446 for the nine months ended September 30, 2014 and 2015 (unaudited), respectively and sales tax of $206 and $424 for the nine months ended September 30, 2014 and 2015 (unaudited), respectively.

i. Research, development and clinical trials:

Research, development and clinical trials, including direct and allocated expenses are expensed as incurred.

j. Shipping and handling costs:

The Company does not bill its customers for shipping and handling costs associated with shipping its delivery systems to its customers. These shipping and handling costs of $405 and $891 for the nine-month period ended September 30, 2014 and 2015 (unaudited), respectively, are included in selling and marketing costs.

k. Accounting for share-based payments:

The Company accounts for share-based compensation in accordance with ASC 718, “Compensation—Stock Compensation.” ASC 718 requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service periods in the company’s consolidated statements of operations.

The Company recognizes compensation costs net of a forfeiture rate only for those shares expected to vest using the accelerated method over the requisite service period of the award, which is generally the option vesting term of four years. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

The Company selected the Black-Scholes option-pricing model as the most appropriate fair value method for its option awards. The option-pricing model requires a number of assumptions, of which the most significant are the share price expected, expected volatility and the expected option term.

The fair value of ordinary shares underlying the options has historically been determined by management and the board of directors. Because there has been no public market for the Company’s ordinary shares, the board of directors has determined fair value of an ordinary share at the time of grant of the option by considering a number of objective and subjective factors including operating and financial performance, the lack of liquidity of share capital, general and industry specific economic outlook and valuations performed amongst other factors. The fair value of the underlying ordinary shares will be determined by the board of directors until such time as the Company’s ordinary shares are listed on an established share exchange or national market system. The Company’s board of directors determined the fair value of ordinary shares for the reported periods, among other factors, based on valuations performed

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using the hybrid method, which is the hybrid between the probability weighted expected return method (PWERM) and the option pricing method, as the Company began to consider initial public offering (IPO) activities commencing in January 2012.

The computation of expected volatility is based on actual historical share price volatility of comparable companies. Expected term of options granted is calculated using the average between the vesting period and the contractual term to the expected term of the options in effect at the time of grant. The Company has historically not paid dividends and has no foreseeable plans to pay dividends and, therefore, uses an expected dividend yield of zero in the option pricing model. The risk-free interest rate is based on the yield of U.S. treasury bonds with equivalent terms.

l. Fair value of financial instruments:

The carrying amounts of cash and cash equivalents, short-term investments, restricted cash, receivables and prepaid expenses, trade payables and other accounts payable and accrued expenses approximate their fair value due to the short-term maturity of such instruments. Based upon the borrowing terms and conditions currently available to the Company, the carrying values of the long-term loans approximate fair value.

m. Basic and diluted net loss per share:

The Company applies the two class method as required by ASC 260-10, “Earnings Per Share.” ASC 260-10 requires the income or loss per share for each class of shares (ordinary and preferred shares) to be calculated assuming 100% of the Company’s earnings are distributed as dividends to each class of shares based on their contractual rights. No dividends were declared or paid during the reported periods.

According to the provisions of ASC 260-10, the Company’s preferred shares are not participating securities in losses and, therefore, are not included in the computation of net loss per share.

Basic and diluted net loss per share is computed based on the weighted average number of ordinary shares outstanding during each year. Diluted loss per share is computed based on the weighted average number of ordinary shares outstanding during the period, plus dilutive potential shares considered outstanding during the period, in accordance with ASC 260-10. Basic and diluted net loss per ordinary share was the same for each period presented as the inclusion of all potential ordinary shares (all preferred shares, options and warrants) outstanding was anti-dilutive.

n. Income taxes:

The Company accounts for income taxes in accordance with ASC 740-10, “Income Taxes.” ASC 740-10 prescribes the use of the liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected reverse. The Company provides a valuation allowance, to reduce deferred tax assets to their estimated realizable value, if needed.

ASC 740 clarifies the accounting for uncertainty in income taxes by prescribing a minimum recognition threshold for a tax position taken or expected to be taken in a tax return that is required to be met before being recognized in the financial statements. ASC 740 also provides guidance on measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition.

o. Concentration of risks:

Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash and cash equivalents, restricted cash and short-term investments.

Cash and cash equivalents and restricted cash are invested in major banks or financial institutions in Jersey (Channel Islands), the United States, Israel, Luxemburg, Switzerland, Japan and Germany. Such investments may be in excess of insured limits and are not insured in other jurisdictions. Generally, these investments may be redeemed upon demand and, therefore, bear minimal risk.

The Company has no off-balance sheet concentrations of credit risk such as foreign exchange contracts, option contracts or other foreign hedging arrangements.

In the nine month period ended September 30, 2015, one payer represented $3,951 or 18% of net revenues, respectively. In the nine month period ended September 30, 2014, the same payer represented $1,890 or 15% of revenues, respectively.

p. Retirement plans and severance pay:

The Company has a 401(k) retirement savings plan for its U.S. employees. Each eligible employee may elect to contribute a portion of the employee’s compensation to the plan. The Company does not make any matching contributions to the plan.

The Company has an occupational benefit plan with a private pension fund for its Swiss employees, whereby the employee and the Company contribute to the pension fund.

The pension expense for the nine months periods ended September 30, 2014 and 2015 (unaudited) was $155 and $218, respectively.

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The majority of the Company’s employees in Israel have subscribed to Section 14 of Israel’s Severance Pay Law, 5723-1963 (“Section 14”). Pursuant to Section 14, Ltd.’s employees covered by this section are entitled to monthly deposits at a rate of 8.33% of their monthly salary, made on their behalf by the Company. Payments in accordance with Section 14 release the Company from any future severance liabilities in respect of those employees. Neither severance pay liability nor severance pay fund under Section 14 for such employees is recorded on the Company’s consolidated balance sheet.

With regard to employees in Israel that are not subject to Section 14, the Company’s liability for severance pay is calculated pursuant to Israeli Severance Pay Law, based on the most recent salary of the relevant employees multiplied by the number of years of employment as of the balance sheet date. These employees are entitled to one month’s salary for each year of employment or a portion thereof. The Company’s liability for these employees is fully provided for through monthly deposits to the employees’ pension and management insurance policies and an accrual. The value of these deposits is recorded as an asset on the Company’s consolidated balance sheet.

The carrying value of the deposited funds is based on the cash surrender value and includes profits accumulated up to the balance sheet date. The deposited funds may be withdrawn only upon the fulfillment of the obligation pursuant to the Israeli Severance Pay Law. Severance pay expense for the nine months periods ended September 30, 2014 and 2015 amounted to $239 and $218, respectively.

q. Contingent liabilities:

The Company accounts for its contingent liabilities in accordance with ASC 450, “Contingencies”. A provision is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated.

With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter. As of September 30, 2015, the Company was not a party to any litigation that could have a material adverse effect on the Company’s business, financial position, results of operations or cash flows.

Recently Issued Accounting Pronouncement

In May 2014, the FASB issued ASU No. 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 while also improving comparability in the financial statements of companies reporting using IFRS and US GAAP. The core principle 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 (that is, payment) to which the company expects to be entitled in exchange for those goods or services. The new standard also will result in enhanced disclosures about revenue, provide guidance for transactions that were not previously addressed comprehensively (for example, service revenue and contract modifications) and improve guidance for multiple-element arrangements. ASU 2014-09 was initially effective for annual and interim reporting periods beginning after December 15, 2016 and may be adopted either on a full retrospective or modified retrospective approach. On July 9, 2015, the FASB approved a one - year deferral of the effective date of the ASU. The revised effective date is for annual reporting periods beginning after December 15, 2017 and interim periods therein, with early adoption permitted as of the original effective date. The Company is evaluating the impact of implementation of this standard on its consolidated financial statements.

NOTE 3:- UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

The accompanying condensed consolidated financial statements include the accounts of the Company and its consolidated subsidiaries, intercompany accounts and transactions have been eliminated. In the opinion of the Company’s management, the condensed consolidated financial statements reflect all adjustments, which are normal and recurring in nature, necessary for fair financial statement presentation. The preparation of these condensed consolidated financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and assumptions that affect the amounts reported in these condensed consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates.

These condensed consolidated financial statements and accompanying notes should be read in conjunction with the Company’s annual consolidated financial statements and the notes thereto for the fiscal year ended December 31, 2014, included in the Company’s Prospectus filed pursuant to Rule 424(b)(1) of the Securities Act on October 2, 2015 with the SEC.

NOTE 4:- SHORT TERM INVESTMENTS

The Company invests in marketable US Treasury Bills (“T-bills”) that are classified as held-to-maturity securities. The amortized cost and recorded basis of the T-bills are presented as short-term investments and their estimated fair value as of December 31, 2014 was

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$44,999.As of September 30, 2015 (unaudited), the amortized cost of the T-bills was $26,999 and the estimated fair value was $27,002.

NOTE 5:- INVENTORIES (in thousands)

NOTE 6:- LONG - TERM LOAN, NET OF DISCOUNT

In January 2015, the Company entered into a five-year term loan agreement (the “Loan Agreement”) with a lender to draw up to $100,000. In January 2015, the Company drew $25,000 from the lender.  The Company may draw the remaining $75,000. at its option at any time through June 30, 2016.  Interest on the outstanding loan is 10.0% annually, payable quarterly in arrears. In addition, there is a 1.5% funding fee payable on the amount drawn on the funding date, a 0.75% pay-down fee on all principal amount repayments to be paid on the date such payments of principal are made and a pre-payment fee of 3.0%, 2.0% or 1.0% if the Company prepays outstanding loan amounts prior to the first, second or third year, respectively, from the initial funding date. The entire outstanding principal loan is due on January 2020. The loan is secured by a first - priority security interest in substantially all assets of the Company. The Loan Agreement sets forth certain affirmative and negative covenants with which the Company must comply on a quarterly basis commencing March 31, 2015 through the term of loan. As of September 30, 2015, the Company was in compliance with its debt covenants.

The total discount of $491 presented net of the loan and additional deferred issuance costs of approximately $1,739 in respect of the loan (presented in other long-term assets in the balance sheet) are amortized to interest expense over the five year term of the loan using the effective interest method.

NOTE 7:- COMMITMENTS AND CONTINGENT LIABILITIES

The facilities of the Company are leased under various operating lease agreements for periods ending no later than 2023. The Company also leases motor vehicles under various operating leases, which expire on various dates, the latest of which is in 2017.

As of December 31, 2014 and September 30, 2015 (unaudited), the Company pledged bank deposits of $130 and $133 respectively to cover bank guarantees in respect of its leases of operating facilities and obtained guarantees by the bank for the fulfillment of the Company’s lease commitments of $281 and $283, respectively.

NOTE 8:- SHARE CAPITAL

Series J Preferred shares investment round

In June 2015, the Company issued 4,068,500 Series J convertible preferred shares at $23.33 per share to certain investors for a total consideration of $94,599 (net of issuance expenses of $319). The Series J preferred shares are senior to the other series of preferred shares on payment of the liquidation preference (equal to $23.33 per share), but otherwise have similar participating preferred rights, dividend rights and voting rights of the other series of preferred shares.

Settlement agreement

In February 2015, the Company entered into a settlement agreement (the “Agreement”) with a third party with respect to a resolution of certain potential disputes regarding intellectual property developed by the Company’s founder and historically assigned to the Company. In exchange for a release of potential disputes from the third party, the Company paid $1,000. on execution of the Agreement and will pay an additional $1,000. (“Additional Payment”) at the earliest of (i) 18 months after signing of the Agreement, (ii) an initial public offering (“IPO”) and (iii) the earlier of consummation of a merger/acquisition (“M&A”) or achievement of a Cumulative Net Sales milestone of $250,000. (as defined pursuant to the Agreement), The Additional Payment was paid in October 2015from the proceeds of the Company’s IPO . The Company will pay an additional $5,500 on the earlier of (i) achievement of the

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Cumulative Net Sales milestone per above and (ii) consummation of an M&A. In addition, the Company agreed to issue 1,005,210 ordinary shares (the “Issued Shares”) to the third party and grant options to the third party to purchase 1,005,210 ordinary shares (the “Granted Options”) that are fully vested and at no cost.  The options terminate at the earlier of (i) 12 months subsequent to the IPO and (ii) immediately prior to an M&A.

In February 2015, the Company contemporaneously entered into a Letter of Agreement (“Letter of Agreement”) with the founder mentioned above and a related party (together, the “Founder”). Pursuant to the Letter of Agreement, in furtherance to a previous indemnification provided by the Founder in 2009, in connection with the intellectual property he assigned to the Company and the Agreement signed above, the Founder agreed to indemnify the Company for the compensation incurred to the third party by providing 2,010,420 ordinary shares which were redeemed and cancelled (the “Redeemed Shares”) in March 2015 to the Company at $5, and may be obligated to pay an additional $2,000. in cash to the Company  upon its request out of the net proceeds from the sale of any ordinary shares by the Founder in a private transaction or - following the consummation of the IPO in an open market transaction if the closing price of the ordinary shares is at least 80% of the price per share for which the ordinary shares were sold in the IPO (after deducting underwriting discounts and commissions and offering expenses). In March 2015, the Company issued the Issued Shares and Granted Options to the third party.

Accordingly, for the year ended December 31, 2014, the Company recorded a provision for a net settlement expense of $1,867. in general and administrative expense, in accordance with ASC 450 reflecting the present value of the cash obligation of $2,000. and the fair value of the Issued Shares and Granted Options to the third party, net of the fair value of the consideration provided by the Founder (Redeemed Shares), which amounted to nil as presented in the statement of shareholder’s equity, in connection with the indemnification provided and the Letter of Agreement.

NOTE 9:- SHARE OPTIONS

In 2003, the Company and its shareholders approved and adopted the 2003 Share Option Plan (the “2003 Plan”), which provided for the grant of options to the Company’s officers, directors, employees and advisors. The options granted generally have a four-year vesting period and expire ten years after the date of grant Since March 2013, when the 2003 Plan expired, the Company has made grants pursuant to the 2013 Share Option Plan (as described below) and, following completion of the IPO in October 2015, all future equity grants will be made under the 2015 Omnibus Incentive Plan (as described below). However, any awards granted under the 2003 Plan that are outstanding as of the IPO will continue to be subject to the terms and conditions of the 2003 Plan and the applicable option award agreement.

In 2013, the Company and its shareholders approved and adopted our 2013 Share Option Plan (the “2013 Plan”) , which provided for the grant of options to the Company’s officers, directors, employees and advisors. In February and March 2015, the Company’s board of directors and its shareholders approved an increase in the number of ordinary shares reserved for grant of options pursuant to the 2013 Plan by 2,956,500 ordinary shares to 13,198,224 ordinary shares. The options granted generally have a four-year vesting period and expire ten years after the date of grant.   Following completion of the IPO, no further awards will be granted under the 2013 Plan and instead, future equity grants will be made under the 2015 Omnibus Incentive Plan, but awards granted under the 2013 Plan that are outstanding as of the IPO shall continue to be subject to the terms and conditions of the 2013 Plan.

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NOTE 9:- SHARE OPTIONS (Cont.)

In August 2015, the Company’s board of directors adopted and established the 2015 Omnibus Incentive Plan (the “ 2015 Plan”). The Company’s shareholders approved the 2015 Plan in September 2015. Under the 2015 Plan, the Company can issue various types of equity compensation awards such as restricted shares, performance shares, restricted stock units, performance units, long-term cash award and other share-based awards.

The options granted generally have a four-year vesting period and expire ten years after the date of grant. Options granted under the 2015 Plan that are cancelled or forfeited before expiration become available for future grant.

In September 2015, the Company’s compensation committee granted options to purchase 921,488 ordinary shares to certain of the Company's employees pursuant to the 2015 Plan, conditioned upon the consummation of the IPO (see Note 11). The per share exercise price of these options is equal to the price per share at which the shares were sold to the public ($22). These awards are subject to continued employment and generally vest over four years.

As of September 30, 2015 (unaudited),  11,057,024 ordinary shares are available for grant under the 2015 Plan after taking into account the grants made in September 2015 conditioned upon the consummation of the IPO (see Note 11).

A summary of the status of the Company’s option plans as of September 30, 2015 (unaudited) and changes during the period then ended is presented below:

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NOTE 9:- SHARE OPTIONS (Cont.)

The options outstanding as of September 30, 2015 (unaudited) have been separated into ranges of exercise prices, as follows:

As of September 30, 2015 (unaudited), there was unrecognized compensation cost of $13,932, which is expected to be recognized over a weighted average period of approximately 3.15 years.

The total non – cash share-based compensation expense related to all of the Company’s equity-based awards, recognized for the three and nine months ended September 30, 2015 and 2014 (unaudited) was comprised as follows:

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NOTE 10:- SUPPLEMENTAL INFORMATION

The Company operates in a single reportable segment.

The following table presents long-lived assets by location:

The Company’s revenues by geographic region, based on the customer’s location are summarized as follows:

NOTE 11:- SUBSEQUENT EVENTS

IPO. On October 7, 2015, the Company completed the IPO of its ordinary shares, which resulted in the sale of 7,500,000 ordinary shares at a price of $22.00 per ordinary share. The Company received net proceeds from the IPO of approximately $150,500, net of underwriting discounts and commissions and estimated offering expenses. In connection with the closing of the IPO, all of the Company’s outstanding preferred shares were converted into ordinary shares of the Company on a one-to-one basis.  The underwriters for the IPO have an option, exercisable through October 31, 2015, to purchase up to 1,125,000 additional ordinary shares to cover over-allotments, if any.  On October 19, 2015, following the partial exercise by the underwriters of their option, the Company sold an additional 376,195 ordinary shares at a price of $22.00 per share and received net proceeds of approximately $7,700, net of underwriting discounts and commissions.

Warrant Exercises- In October 2015, certain investors exercised warrants for an aggregate of 565,696 ordinary shares.  Total purchase price received by the Company related to the warrant exercises was $2,003.

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Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations

Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to provide information to assist you in better understanding and evaluating our financial condition and results of operations. We encourage you to read this MD&A in conjunction with our consolidated financial statements for the period ended September 30, 2015 included in Part I, Item 1 of this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements that involve risks and uncertainties.  As a result of many factors, such as those set forth under Part II, Item 1A, Risk Factors, of this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements.

Overview

We are a commercial-stage oncology company developing a novel, proprietary therapy called TTFields for the treatment of solid tumor cancers. TTFields is a low-toxicity anti-mitotic treatment that uses low-intensity, intermediate frequency, alternating electric fields to exert physical forces on key molecules inside cancer cells, disrupting the basic machinery necessary for normal cell division, leading to cancer cell death. Physicians have typically treated patients with solid tumors using one or a combination of three principal treatment modalities—surgery, radiation and pharmacological therapies. Despite meaningful advancements in each of these modalities, a significant unmet need to improve survival and quality of life remains. We believe we will establish TTFields as a new treatment modality for a variety of solid tumors that increases survival without significantly increasing side effects when used in combination with other cancer treatment modalities.

We view our operations and manage our business in one operating segment. We have incurred significant losses and cumulative negative cash flows from operations since our founding in 2000. Our net losses were $80.7 million for the year ended December 31, 2014 and $78.6 million for the nine months ended September 30, 2015. As of September 30, 2015, we had an accumulated deficit of $329.1 million. Our net losses primarily resulted from costs incurred in connection with our pre-clinical and clinical trial programs, costs incurred in our commercial launch efforts, including the U.S. launch of Optune for the treatment of recurrent GBM, and general and administrative costs necessary to operate as a multi-national oncology business. To date, we have financed our operations primarily through the issuance and sale of our convertible preferred shares and the proceeds from long-term loans. As of September 30, 2015, we had received a total of $454.3 million from the sale of our convertible preferred shares that were authorized, issued and outstanding prior to the closing of our initial public offering (“IPO”) on October 7, 2015.  On September 16, 2015, we effected a 5.913 for 1 share split applicable to our ordinary shares and all classes of our preferred shares.  On October 7, 2015, all of our convertible preferred shares were converted to our ordinary shares on a one-for-one basis upon the closing of our IPO.  Our IPO closed on October 7, 2015, and we issued and sold 7.5 million ordinary shares at a per share price to the public of $22.00. We received cash proceeds of approximately $150.5 million from the IPO, net of underwriting discounts and commissions and estimated offering expenses.  On October 19, 2015, following the partial exercise by the underwriters of their over-allotment option, we issued and sold an additional 376,195 ordinary shares at a per share price to the public of $22.00 and received net proceeds of approximately $7.7 million, net of underwriting discounts and commissions.

In October 2015, we received U.S. Food and Drug Administration (“FDA”) approval to market and sell Optune for the treatment of adult patients with newly diagnosed glioblastoma in combination with temozolomide.  We have commenced our commercial launch for that indication in the United States. In the same month, we began placing a CE mark on our newly designed second generation Optune system and began roll-out of that system to patients in Germany.  We plan to initiate a broader roll-out to additional countries in Europe by the end of the year.

We expect to continue to incur significant expenses and operating losses for at least the next several years. We expect our research, development and clinical trials expenses to increase in connection with our ongoing activities, particularly as we continue the research, development and clinical trials of TTFields and related delivery system candidates, including multiple simultaneous clinical trials for certain delivery system candidates, some of which are in, or we expect will be entering, late-stage clinical development. In addition, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We may need additional funding to support the continuation of our operating activities. Until we can generate substantial revenues (which may not occur), we expect to finance our cash needs through the proceeds of our IPO and availability under our term loan credit facility, and possibly also from collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. We will need to generate significant revenues to achieve profitability, and we may never do so.

Critical accounting policies and estimates

In accordance with U.S. GAAP, in preparing our financial statements, we must make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of net revenues and expenses during the reporting period. We develop and periodically change these

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estimates and assumptions based on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates.

The critical accounting policies requiring estimates, assumptions and judgments that we believe have the most significant impact on our consolidated financial statements are described below.

Revenue recognition

The TTFields delivery system, currently marketed for newly diagnosed and recurrent GBM as Optune, is comprised of two main components: (1) an electric field generator and (2) transducer arrays and related accessories that are disposable supplies to the device, or the transducer arrays. We retain title to the electric field generator, and the patient is provided replacement transducer arrays for the device during the term of treatment. The electric field generator and transducer arrays are always supplied and function together and are not sold on a standalone basis.

Revenues are recognized when persuasive evidence of an arrangement exists, delivery of the electric field generator and transducer arrays has occurred, the price is fixed or determinable and collectability is reasonably assured. The evidence of an arrangement generally consists of a prescription, a patient service agreement and the verification of eligibility and insurance with the patient’s third-party insurance company. We generally bill third-party payers a monthly rental fee for use of Optune by patients. As such, we take assignment of the benefit and risk of collection from the third-party payer. Patients often have out-of-pocket costs for the amount not covered by their third-party payer and we bill the patient directly for the amounts of their co-pays and deductibles subject to our patient assistance programs.

For the reported periods, all revenues were recognized when cash was collected as the price is not fixed or determinable and the collectability cannot be reasonably assured. The price is not fixed or determinable since we do not have sufficient history with third-party payers to reliably estimate their individual payment patterns and as such cannot reliably estimate the amount that would be ultimately collected. Once sufficient history is established and we can demonstrate that we can reliably estimate the amounts that would be ultimately collected per third-party payer or payer group and the above criteria are met, we will recognize revenues ratably over the term of the patient’s use of Optune.

Revenues are presented net of indirect taxes incurred in the reported period, including the U.S. medical device excise tax and sales tax, regardless of whether the revenues associated with those taxes are reported on a cash basis.

Long-lived assets

Property and equipment and field equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful life of the relevant asset. We make estimates of the useful life of our property and equipment and field equipment, based on similar assets purchased in the past and our historical experience with such similar assets, in order to determine the depreciation expense to be recorded for each reporting period.

Our field equipment consists of equipment being utilized under rental agreements accounted for on a monthly basis as an operating lease, as well as service pool equipment. Service pool equipment is equipment owned and maintained by us that is swapped for equipment that needs repair or maintenance by us while being used by a patient. We record a provision for any excess, lost or damaged equipment when warranted based on an assessment of the equipment.

We assess impairment whenever events or changes in circumstances indicate that the carrying amount of the asset is impaired or the estimated useful life is no longer appropriate. Circumstances such as changes in technology or in the way an asset is being used may trigger an impairment review.

Inventories

Inventories are stated at the lower of cost or market. We regularly evaluate the ability to realize the value of inventory. If actual demand for our delivery systems declines or market conditions are less favorable than those projected, inventory write-offs may be required.

Income taxes

As part of the process of preparing our consolidated financial statements, we are required to calculate our income taxes based on taxable income by jurisdiction. We make certain estimates and judgments in determining our income taxes, including valuation of our

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uncertain tax positions, for financial statement purposes. Significant changes to these estimates may result in an increase or decrease to our tax provision in the subsequent period when such a change in estimate occurs.

Uncertain tax positions are based on estimates and assumptions that have been deemed reasonable by management. Our estimates of unrecognized tax benefits and potential tax benefits may not be representative of actual outcomes.

Results of Operations

(Unaudited; tables in thousands, except for share and per share data, operating statistics and % change data)

The following table includes certain commercial patient operating statistics for and as of the end of the periods presented.

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Three Months Ended September 30, 2015 Compared to Three Months Ended September 30, 2014

Net revenues.  Substantially all of our revenues are derived from patients using our TTFields delivery system, marketed as Optune in our currently active markets. Total cash payments received during the nine months ended September 30, 2015 were recorded as revenues for Optune provided to patients in the current and prior periods.  Net revenues increased by $4.6 million, or 105%, to $9.0 million for the three months ended September 30, 2015 from $4.4 million for the three months ended September 30, 2014. The increase was primarily due to an increase of $4.3 million in U.S. commercial sales of Optune, primarily driven by a 60% increase in the number of US certified centers at September 30, 2014 versus at September 30, 2015, from 135 to 215, respectively, and increased US sales and marketing efforts, and to an increase of $0.3 million in commercial sales of Optune in our currently active markets in Europe (primarily Germany and Switzerland).

Cost of revenues.  Our cost of revenues is comprised primarily of (i) cost of the disposable transducer arrays purchased from third-party manufacturers, (ii) depreciation expense for the field equipment, including the electric field generator used by patients and (iii) personnel, warranty and overhead costs such as facilities, freight and depreciation of property, plant and equipment associated with managing our inventory, warehousing and order fulfillment functions.  Our cost of revenues increased by $3.1 million, or 119%, to $5.7 million for the three months ended September 30, 2015 from $2.6 million for the three months ended September 30, 2014. The increase was due to the increased volume of Optune shipments to commercial patients, comprised of $1.8 million in the cost of transducer arrays shipped to patients mainly in the United States, $0.8 million in personnel, $0.4 million in facility and other costs and $0.1 million in field equipment depreciation expense. The personnel, facility and other costs reported for the three months ended September 30, 2015 were driven by our efforts to establish the infrastructure necessary to support our commercialization efforts.

Operating Expenses.

Our operating expenses consist of research, development and clinical trials, sales and marketing and general and administrative expenses.  Personnel costs are a significant component for each category of operating expenses and consist of wages, benefits and bonuses.  Personnel costs also include share-based compensation.  

Research, development and clinical trials expenses.    Research, development and clinical trials expenses increased by $0.9 million, or 10%, to $10.2 million in the three months ended September 30, 2015 from $9.3 million for the three months ended September 30, 2014. The change was primarily due to an increase of $0.2 million in personnel costs (including share-based compensation) due to increased headcount related to the expansion of research and development activity for possible future indications, an increase of $0.9 million in supported third-party research and facility expenses, offset by a decrease in clinical trials and subcontractors expenses of $0.2 million as a result of the termination of EF-14 in the fourth quarter 2014.  Total non-cash share-based compensation for research, development and clinical trials personnel for the three months ended September 30, 2015 and 2014 was $0.7 million and $0.3 million, respectively.

Sales and marketing expenses.    Sales and marketing expenses increased by $3.5 million, or 66%, to $8.9 million for the three months ended September 30, 2015 from $5.4 million for the three months ended September 30, 2014. The change was due to an increase of $3.0 million in advertising and other marketing expenses and an increase of $0.5 million for increased headcount to support marketing activities (including share-based compensation).  Total non-cash share-based compensation for sales and marketing personnel for the three months ended September 30, 2015 and 2014 was $0.6 million and $0.3 million, respectively.

General and administrative expenses.    General and administrative expenses increased by $3.4 million, or 67%, to $8.4 million for the three months ended September 30, 2015 from $5.0 million for the three months ended September 30, 2014. The change was primarily due to an increase of $1.7 million in personnel costs due to increased headcount (including share-based compensation expenses) to support the growth and operation of our business, and an increase of $1.5 million in facilities and costs associated with preparing the

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company for its initial public offering.  Total non-cash share-based compensation for general and administrative personnel for the three months ended September 30, 2015 and 2014 was $1.7 million and $0.7 million, respectively.

Financial expenses, net.    Financial expenses, net primarily consists of credit facility interest expense and related debt issuance costs, interest income from cash balances and short-term investments and gains (losses) from foreign currency transactions.  Our functional currency is the U.S. dollar.  We have historically held substantially all of our cash balances in U.S. dollar denominated accounts to minimize the risk of translational currency exposure.  Financial expenses, net increased by $0.8 million to $0.8 million for the three months ended September 30, 2015, primarily due to finance expense, including interest, amortization of discount and deferred issuance costs related to our term loan credit facility entered into in January 2015.

Income taxes.    Income taxes increased by $0.6 million to $1.0 million for the three months ended September 30, 2015. The change was primarily attributable to an increase in the statutory tax provision for Switzerland, the United States and Japan.

Nine Months Ended September 30, 2015 Compared to Nine Months Ended September 30, 2014

Net revenues.    Net revenues increased by $9.0 million, or 77%, to $20.7 million for the nine months ended September 30, 2015 from $11.7 million for the nine months ended September 30, 2014. The increase was primarily due to an increase of $8.2 million in U.S. commercial sales of Optune, primarily driven by a 60% increase in the number of US certified centers at September 30, 2014 versus at September 30, 2015, from 135 to 215, respectively, and increased US sales and marketing efforts and an increase of $0.8 million in commercial sales of Optune in our currently active markets in Europe.

Cost of revenues.    Our cost of revenues increased by $6.9 million, or 93%, to $14.3 million for the nine months ended September 30, 2015 from $7.4 million for the nine months ended September 30, 2014.

The increase was primarily due to an increase of $4.4 million in transducer arrays shipped to U.S. commercial patients, an increase of $0.8 million in transducer arrays shipped to patients in Europe, an increase of $0.3 million for field equipment depreciation and an increase in personnel costs of $1.2 million associated with new employees.

Operating expenses

Research, development and clinical trials expenses.    Research, development and clinical trials expenses increased by $3.7 million, or 27%, to $32.9 million for the nine months ended September 30, 2015 from $29.2 million for the nine months ended September 30, 2014. The change is primarily due to an increase in clinical trials expenses of $0.5 million, an increase of $1.1 million of personnel costs (including share-based compensation), and an increase of $0.2 million for regulatory expenses related to the preparation of approval applications to the Japanese Ministry of Health, Labor and Welfare for the treatment of recurrent GBM and the FDA in the United States for the treatment of newly diagnosed GBM in combination with temozolomide, an increase of related supported third-party research expenses of $1.0 million and an increase of $1.0 million in facility expenses due to an increase in activity in Switzerland and Japan.  Total non-cash share-based compensation for research, development and clinical trials personnel for the nine months ended September 30, 2015 and 2014 was $1.7 million and $0.5 million, respectively.

Sales and marketing expenses.    Sales and marketing expenses increased by $7.7 million, or 47%, to $24.1 million for the nine months ended September 30, 2015 from $16.4 million for the nine months ended September 30, 2014. The increase was driven by an increase

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of $1.8 million of personnel costs (including share-based compensation), an increase of $4.2 million in advertising and other marketing expenses and an increase of $1.7 million in advisory fees.  Total non-cash share-based compensation for sales and marketing personnel for the nine months ended September 30, 2015 and 2014 was $1.6 million and $0.8 million, respectively.

General and administrative expenses.    General and administrative expenses increased by $6.9 million, or 44%, to $22.7 million for the nine months ended September 30, 2015 from $15.8 million for the nine months ended September 30, 2014. The increase was primarily related to an increase in personnel costs of $4.0 million (including share-based compensation) due to increased headcount to support the growth and operation of our business, an increase of $0.6 million for costs of professional services relating to the implementation of our new SAP ERP system and legal services, and an increase of $2.3 million related to facility and costs associated with preparing the company for its initial public offering.  Total non-cash share-based compensation for general and administrative personnel for the nine months ended September 30, 2015 and 2014 was $4.0 million and $2.0 million, respectively.

Financial expenses, net.    Financial expenses, net increased by $2.2 million, or 2,200%, to $2.3 million for the nine months ended September 30, 2015 from $0.1 million for the nine months ended September 30, 2014. The change was primarily due to the finance expenses, including interest, amortization discount and deferred issuance costs, related to our term loan credit facility entered into in January 2015.

Income taxes.    Income taxes increase by $2.5 million, or 465%, to $3.0 million for the nine months ended September 30, 2015 from $0.5 million for the nine months ended September 30, 2014. The change was primarily attributable to an increase in the statutory tax provision related to Switzerland, the United States and Japan.

Liquidity and Capital Resources

Sources of Liquidity

We have incurred significant losses and cumulative negative cash flows from operations since our founding in 2000. As of September 30, 2015, we had an accumulated deficit of $355.1 million. We expect to continue to incur losses until our delivery systems achieve market acceptance. To date, we have primarily financed our operations through the issuance and sale of our convertible preferred shares and the proceeds from long-term loans. As of September 30, 2015, we had received a total of $454.3 million from the sale of our convertible preferred shares, including the sale of shares of our Series J convertible preferred stock in June 2015 for net proceeds of $94.6 million, all of which converted into our ordinary shares upon consummation of our IPO.

As of September 30, 2015, we had $110.3 million of cash and cash equivalents, including short-term investments of $27.0 million. In January 2015, we entered into the Loan and Security Agreement dated as of January 7, 2015, between us, as borrower, and Biopharma Secured Investments III Holdings Cayman LP, as lender (the “Term Loan Credit Facility”), for up to $100.0 million, of which we drew $25.0 million on entering into the facility. In June 2015, we raised $94.6 million through the issuance of our Series J convertible preferred shares.  Our IPO closed on October 7, 2015 and we issued and sold 7.5 million ordinary shares. We received cash proceeds of approximately $150.5 million from the IPO, net of underwriting discounts and commissions and estimated offering expenses.  We believe our cash and cash equivalents as of September 30, 2015, together with the net proceeds of the IPO and availability under our Term Loan Credit Facility, are sufficient for our operations for at least the next 12 months based on our existing business plan and our ability to control the timing of significant expense commitments. We expect that our research, development and clinical trials expenses, sales and marketing expenses and general and administrative expenses will continue to increase over the next several years. As a result, we may need to raise additional capital in the future to fund our operations.

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Operating activities

Net cash used in operating activities primarily represents our net loss for the periods presented. Adjustments to net loss for non-cash items include depreciation, share-based compensation and accrued interest. Operating cash flows are also impacted by changes in operating assets and liabilities, principally inventories, prepaid expenses, trade payables and accrued expenses.

Net cash used in operating activities was $73.8 million for the nine months ended September 30, 2015, as compared to $56.7 million for the nine months ended September 30, 2014, reflecting a net loss of $78.7 million and a change of $4.8 million in our net operating assets and liabilities, offset by non-cash charges of $9.7 million.

The change in our net operating assets and liabilities was primarily the result of an increase in our inventories of $7.7 million necessary to meet anticipated demand and an increase in other receivables of $4.5 million, offset by an increase in trade payables of $4.6 million and other payables of $3.0 million. Non-cash charges included $7.4 million of share-based compensation, $2.0 million of depreciation and $0.2 million of amortization related to our Term Loan Credit Facility.

Investing activities

Our investing activities consist primarily of capital expenditures to purchase property and equipment and field equipment, as well as investments in and redemptions of our short-term investments.

Net cash provided by investing activities was $10.7 million in the nine months ended September 30, 2015 attributable to our receipt of $77.0 million from the maturity of short-term investments, offset by the purchase of new short-term investments of $59.0 million, purchases of $3.6 million of property and equipment and purchases of $3.5 million of field equipment. Net cash used in investing activities for the same period in 2014 was $39.2 million, attributable to the purchase of $107.9 million of short-term investments, purchases of property and equipment of $0.4 million and purchases of field equipment of $0.9 million, offset by receipt of $69.0 million from the maturity of short-term investments and a decrease in restricted cash of $1.0 million.

Financing activities

To date, our primary financing activities have been the sale of our convertible preferred shares, our IPO and the proceeds from long-term loans.

Net cash provided by financing activities was $115.7 million for the nine months ended September 30, 2015, attributable to the net proceeds from the issuance of Series J preferred shares of $94.6 million and borrowings under our Term Loan Credit Facility of $22.9 million, offset by deferred IPO costs of $1.7 million.  Net cash provided by financing activities was $0.1 million in the same period of 2014, attributable to a long-term loan.

Term Loan Credit Facility

Our material outstanding indebtedness consists of our Term Loan Credit Facility, which provides for up to $100.0 million of borrowings in up to four draws, the first of which was made on January 30, 2015 in the amount of $25.0 million. Interest on the outstanding loan is 10% annually, payable quarterly in arrears. As of September 30, 2015, the aggregate principal balance of amounts outstanding under the Term Loan Credit Facility was approximately $25.0 million. The commitments made by the lender to make additional term loans terminate on June 30, 2016. We may prepay the term loans, in whole, at any time, and must prepay in the event of a change of control, in each case, subject to a pay-down fee, prepayment premium and/or make-whole payment. The funding fee payable on the amount drawn on the funding date is 1.5%, the pay-down fee on all principal payments to be paid on the date such payments are made is 0.75% and the pre-payment fee if we prepay outstanding loan amounts prior to the first, second or third year from the initial funding date is 3.0%, 2.0% or 1.0%, respectively.

All obligations under the Term Loan Credit Facility are guaranteed by certain of our current and future domestic direct and indirect subsidiaries. In addition, the obligations under the Term Loan Credit Facility are secured by a first-priority security interest in substantially all of the property and assets of, as well as the equity interests owned by, us and the other guarantors.

The Term Loan Credit Facility has a minimum liquidity covenant, which is tested quarterly. In addition, we must meet certain pro forma net sales requirements. The Term Loan Credit Facility contains other customary covenants.

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Contractual Obligations and Commitments

The following summarizes our significant contractual obligations at December 31, 2014: