Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2015 | Aug. 03, 2015 | |
Document and Entity Information | ||
Entity Registrant Name | T2 Biosystems, Inc. | |
Entity Central Index Key | 1,492,674 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 20,324,741 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q2 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 53,289 | $ 73,849 |
Accounts receivable | 389 | 201 |
Prepaid expenses and other current assets | 628 | 1,076 |
Inventories | 569 | 115 |
Restricted cash | 80 | |
Total current assets | 54,875 | 75,321 |
Property and equipment, net | 7,809 | 2,760 |
Restricted cash, net of current portion | 260 | 260 |
Deferred tax assets | 313 | 313 |
Other assets | 456 | 480 |
Total assets | 63,713 | 79,134 |
Current liabilities: | ||
Accounts payable | 1,562 | 735 |
Accrued expenses | 3,475 | 3,662 |
Notes payable | 305 | 295 |
Deferred revenue | 1,776 | 80 |
Deferred tax liabilities | 313 | 313 |
Lease incentives | 259 | 87 |
Total current liabilities | 7,690 | 5,172 |
Notes payable, net of current portion | 20,522 | 20,660 |
Lease incentives, net of current portion | 1,136 | 106 |
Other liabilities | $ 313 | $ 195 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued | ||
Common stock, $0.001 par value; 200,000,000 shares authorized; 20,312,980 and 20,041,645 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively | $ 20 | $ 20 |
Additional paid-in capital | 159,241 | 156,576 |
Accumulated deficit | (125,209) | (103,595) |
Total stockholders' equity | 34,052 | 53,001 |
Total liabilities and stockholders' equity | $ 63,713 | $ 79,134 |
Consolidated Balance Sheet (Par
Consolidated Balance Sheet (Parentheticals) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
Consolidated Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 20,312,980 | 20,041,645 |
Common stock, shares outstanding | 20,312,980 | 20,041,645 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Consolidated Statements of Operations and Comprehensive Loss | ||||
Product revenue | $ 10 | |||
Research revenue | $ 564 | 743 | ||
Total revenue | 564 | 753 | ||
Costs and expenses: | ||||
Cost of product revenue | 3 | |||
Research and development | 6,651 | $ 4,703 | 12,520 | $ 9,768 |
Selling, general and administrative | 4,437 | 2,446 | 8,905 | 4,288 |
Total costs and expenses | 11,088 | 7,149 | 21,428 | 14,056 |
Loss from operations | (10,524) | (7,149) | (20,675) | (14,056) |
Interest expense, net | (477) | (80) | (954) | (166) |
Other income (expense), net | 6 | (74) | 15 | (1) |
Net loss | (10,995) | (7,303) | (21,614) | (14,223) |
Comprehensive loss | (10,995) | (7,303) | (21,614) | (14,223) |
Reconciliation of net loss to net loss applicable to common stockholders: | ||||
Net loss | (10,995) | (7,303) | (21,614) | (14,223) |
Accretion of redeemable convertible preferred stock to redemption value | (1,906) | (3,812) | ||
Net loss applicable to common stockholders | $ (10,995) | $ (9,209) | $ (21,614) | $ (18,035) |
Net loss per share applicable to common stockholders - basic and diluted | $ (0.54) | $ (6.35) | $ (1.07) | $ (12.60) |
Weighted-average number of common shares used in computing net loss per share applicable to common stockholders - basic and diluted | 20,260,591 | 1,451,124 | 20,171,051 | 1,431,542 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Operating activities | ||
Net loss | $ (21,614) | $ (14,223) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 600 | 299 |
Stock-based compensation expense | 1,577 | 505 |
Noncash interest expense | 180 | 21 |
Change in fair value of warrants | 1 | |
Loss on disposal of asset | (1) | |
Deferred rent | (67) | (13) |
Changes in operating assets and liabilities: | ||
Accounts receivable | (188) | |
Prepaid expenses and other current assets | 447 | (8) |
Inventories | (453) | |
Accounts payable | 827 | (281) |
Accrued expenses and other liabilities | (396) | 1,509 |
Deferred revenue | 1,695 | |
Net cash used in operating activities | (17,392) | (12,191) |
Investing activities | ||
Purchases of property and equipment | (4,184) | (508) |
Decrease in restricted cash | 80 | |
Net cash used in investing activities | (4,104) | (508) |
Financing activities | ||
Proceeds from issuance of common stock and stock option exercises, net | 1,088 | 96 |
Payment of deferred initial public offering costs | (777) | |
Payment of deferred financing costs | (50) | |
Repayments of notes payable | (152) | (892) |
Net cash provided by (used in) financing activities | 936 | (1,623) |
Net decrease in cash and cash equivalents | (20,560) | (14,322) |
Cash and cash equivalents at beginning of period | 73,849 | 30,198 |
Cash and cash equivalents at end of period | 53,289 | 15,876 |
Supplemental disclosures of cash flow information | ||
Cash paid for interest | 716 | 125 |
Supplemental disclosures of noncash investing and financing activities | ||
Accrued costs of property and equipment | $ 1,595 | |
Accretion of Series A-1, A-2, B, C, D and E redeemable convertible preferred stock to redemption value | 3,812 | |
Deferred financing costs incurred but unpaid at period end | 85 | |
Initial public offering costs incurred but unpaid at period end | $ 1,309 |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 30, 2015 | |
Nature of Business | |
Nature of Business | 1. Nature of Business T2 Biosystems, Inc. (the “Company”) was incorporated on April 27, 2006 as a Delaware corporation with operations based in Lexington, Massachusetts. The Company is an in vitro diagnostic company that has developed an innovative and proprietary platform that enables rapid, sensitive and simple direct detection of pathogens, biomarkers and other abnormalities across a variety of unpurified patient sample types. The Company is using its T2 Magnetic Resonance platform (“T2MR”) to develop a broad set of applications aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. The Company’s initial development efforts target sepsis, hemostasis and Lyme disease, areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. On September 22, 2014, the Company received market authorization from the U.S. Food and Drug Administration (“FDA”) for its first two products, the T2Dx Instrument (“T2Dx”) and T2Candida Panel (“T2Candida”). The Company has devoted substantially all of its efforts to research and development, business planning, recruiting management and technical staff, acquiring operating assets, raising capital, and, most recently, preparing of the commercialization of its products. Liquidity At June 30, 2015 the Company has cash and cash equivalents of $53.3 million and an accumulated deficit of $125.2 million. The future success of the Company is dependent on its ability to successfully commercialize its recently authorized products, obtain regulatory clearance for and successfully launch its future product candidates and ultimately attain profitable operations, and obtain additional capital. Historically, the Company has funded its operations primarily through its August 2014 initial public offering, private placements of redeemable convertible preferred stock and through debt financing arrangements. Management believes that its existing cash resources at June 30, 2015 together with the additional remaining liquidity of up to $10.0 million of available borrowings from existing debt facilities (Note 5) will be sufficient to allow the Company to fund its current operating plan through at least the next 12 months. The Company is subject to a number of risks similar to other newly commercial life science companies, including, but not limited to commercially launching the Company’s products, development and market acceptance of the Company’s product candidates, development by its competitors of new technological innovations, protection of proprietary technology, and raising additional capital. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2015 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as defined in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, T2 Biosystems Securities Corporation. All intercompany balances and transactions have been eliminated. Unaudited Interim Financial Information Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. The accompanying interim condensed consolidated balance sheet as of June 30, 2015, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2015 and 2014, the condensed consolidated statements of cash flows for the six months ended June 30, 2015 and 2014 and the related financial data and other information disclosed in these notes are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2015, and the results of its operations and its cash flows for the three and six months ended June 30, 2015 and 2014. The results for the three and six months ended June 30, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015, any other interim periods, or any future year or period. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company views its operations and manages its business in one operating segment, which is the business of developing and, upon regulatory clearance, launching commercially its diagnostic products aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. Net Loss Per Share Basic net loss per share is calculated by dividing net loss applicable to common stockholders, which is net loss plus accretion of redeemable convertible preferred stock to redemption value in the period, by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method for outstanding stock options and warrants. For purposes of the diluted net loss per share calculation, redeemable convertible preferred stock, warrants to purchase redeemable convertible preferred stock and stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect, including the related impact to the numerator of the fair value adjustment of the warrant and the impact to the denominator of the warrant shares, would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders was the same for all periods presented. Guarantees From time to time, the Company enters into indemnification agreements in the ordinary course of business, including, but not limited to, indemnification agreements with directors and officers, within its lease agreements for office, laboratory and manufacturing space, and with certain suppliers and business partners. As of June 30, 2015 and December 31, 2014, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. Revenue Recognition The Company generates revenue from product sales and research and development agreements with third parties. The Company recognizes revenue in accordance with FASB ASC Topic 605, Revenue Recognition (“ASC 605”). Accordingly, the Company recognizes revenue when all of the following criteria have been met: i. Persuasive evidence of an arrangement exists ii. Delivery has occurred or services have been rendered iii. The seller’s price to the buyer is fixed or determinable iv. Collectability is reasonably assured Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue. The Company offers customers the choice either to purchase a T2Dx outright or to allow the placement of a Company-owned T2Dx at the customer site pursuant to a “reagent rental” agreement. Revenue earned from activities performed pursuant to research and development agreements is reported as research revenue in the statements of operations and comprehensive loss, using the proportional performance method as the work is completed, limited to payments earned, and the related costs are expensed as incurred as research and development expense. The timing of receipt of cash from the Company’s research and development agreements generally differs from when revenue is recognized. For multiple-element arrangements, the Company identifies the deliverables included within each agreement and evaluates which deliverables represent separate units of accounting. The Company accounts for those components as separate elements when the following criteria are met: (1) the delivered items have value to the customer on a stand-alone basis; and, (2) if there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within its control. The consideration received is allocated among the separate units of accounting based on management’s best estimate of selling price, and the applicable revenue recognition criteria are applied to each of the separate units. The determination that multiple elements in an arrangement meet the criteria for separate units of accounting requires the Company’s management to exercise its judgment. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory (“ASU 2015-11”) The standard simplifies the subsequent measurement of inventory by requiring inventory to be measured at the lower of cost and net realizable value for entities using the first-in-first out method of valuing inventory. ASU 2015-11 eliminates other measures required by current guidance to determine net realizable value. ASU 2015-11 is effective for fiscal years beginning after December 15, 2016 and interim periods within those fiscal years and early adoption is permitted. The Company has not adopted ASU 2015-11 and does not expect the new guidance to have a material effect on its condensed consolidated financial statements. In April 2015, the FASB issued ASU No. 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement (“ASU 2015-05”). The standard clarifies that customers in cloud computing arrangements should determine whether the arrangement includes a license of software by applying the same guidance as cloud service providers and eliminates the existing requirement for customers to account for software licenses acquired by analogizing to the guidance on leases. It is effective for annual periods beginning on or after December 15, 2015, including interim periods within those annual periods, and early adoption is permitted. Adoption of ASU 2015-05 can either be applied (1) prospectively to all arrangements entered into or materially modified after the effective date or (2) retrospectively. The Company has not adopted the guidance prescribed by ASU 2015-05 and does not expect the new guidance to have a material effect on its condensed consolidated financial statements. In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs (“ASU 2015-03”). This standard amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. It is effective for annual reporting periods beginning after December 15, 2015, but early adoption is permitted. Adoption of ASU 2015-03 is applied retrospectively. The Company has not adopted the guidance prescribed by ASU 2015-03 and does not expect the new guidance to have a material effect on its condensed consolidated financial statements. In June 2014, the FASB issued amended guidance, ASU No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”), which is applicable to revenue recognition that will now be effective for the Company for the year ending December 31, 2018, as a result of the deferral of the effective date adopted by the FASB in July 2015. The new guidance must be adopted using either a full retrospective approach for all periods presented or a modified retrospective approach. Early adoption prior to the original adoption date of ASU 2014-09 is not permitted. The new guidance applies a more principles-based approach to revenue recognition. The Company is evaluating the new guidance and the expected effect on the Company’s condensed consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2015 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements The Company measures the following financial assets at fair value on a recurring basis. The following tables set forth the Company’s financial assets carried at fair value categorized using the lowest level of input applicable to each financial instrument as of June 30, 2015 and December 31, 2014 (in thousands): Balance at June 30, 2015 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Cash $ $ $ — $ — Money market funds — — Restricted cash — — $ $ $ — $ — Balance at December 31, 2014 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Cash $ $ $ — $ — Money market funds — — Restricted cash — — $ $ $ — $ — For certain financial instruments, including accounts payable and accrued expenses, the carrying amounts approximate their fair values as of June 30, 2015 and December 31, 2014 because of their short-term nature. At June 30, 2015 and December 31, 2014, the carrying value of the Company’s debt approximated fair value, which was determined using Level 3 inputs, including a market interest rate. |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 6 Months Ended |
Jun. 30, 2015 | |
Supplemental Balance Sheet Information | |
Supplemental Balance Sheet Information | 4. Supplemental Balance Sheet Information Inventories Inventories are stated at the lower of cost or market value on a first-in, first-out basis and are comprised of the following (in thousands): June 30, December 31, 2015 2014 Raw materials $ $ Work-in-process Finished goods — Total inventories $ $ Property and Equipment Property and equipment consists of the following (in thousands): June 30, 2015 December 31, 2014 Office and computer equipment $ $ Software Laboratory equipment Furniture Manufacturing tooling and molds Leasehold improvements T2Dx Instruments and components Construction in progress Less accumulated depreciation and amortization ) ) Property and equipment, net $ $ Construction in progress is primarily comprised of equipment and leasehold improvement construction projects that have not been placed in service. T2Dx Instruments and components is comprised of raw materials and work-in-process inventory that are expected to be used or used to produce Company-owned instruments, based on our business model and forecast, and completed instruments that will be used for internal research and development or reagent rental agreements with customers. Such completed instruments have not yet been placed in service. Accrued Expenses Accrued expenses consist of the following (in thousands): June 30, December 31, 2015 2014 Accrued payroll and compensation $ $ Accrued research and development expenses Accrued professional services Other accrued expenses Total accrued expenses $ $ |
Debt
Debt | 6 Months Ended |
Jun. 30, 2015 | |
Debt | |
Debt | 5. Debt On July 11, 2014, the Company entered into a loan and security agreement (“Note Agreement”) with two lenders to borrow up to $30.0 million for operations. The Note Agreement allows the Company to borrow amounts in two tranches, up to $20.0 million (drawn in amounts not less than $10.0 million upon closing and the remainder drawn in amounts not less than $5.0 million draws) by December 31, 2014 for tranche A and up to $10.0 million by June 30, 2015 for tranche B. Under the Note Agreement, borrowings under tranche B are only available to the Company if both of the following conditions are met by June 30, 2015: (a) the Company receives Section 510(k) clearance from the FDA on the Company’s T2Dx and T2Candida products and (b) the Company completes a public or private stock offering, equity raise or strategic partner arrangement resulting in the receipt of at least $30.0 million in net proceeds by the Company. As the Company received FDA approval in September 2014 and the Company closed its initial public offering in August 2014, the borrowings under tranche B are now available as both of the required conditions have been met. On May 27, 2015, the Company entered into the First Amendment to the Note Agreement whereby the availability to draw up to $10.0 million for tranche B was extended from June 30, 2015 to December 31, 2015. Commencing July 1, 2015, the Company will incur a fee equal to 1.0% per annum of any undrawn amounts under tranche B. This fee is payable on the date tranche B is drawn or upon the expiration of the draw period. All other terms of the Note Agreement remain in effect. Through June 30, 2015, the Company received proceeds of $19.7 million under tranche A, net of deferred financing costs. To date, the Company has not drawn the remaining tranche B available borrowings of $10.0 million. The amounts borrowed under the Note Agreement are collateralized by substantially all of the assets of the Company and bear interest at the one-month LIBOR plus 7.05%, which was 7.24% on June 30, 2015. The Company will pay interest only payments on the amounts borrowed under the Note Agreement through July 31, 2016. After the interest only period, the Company will repay the amounts borrowed in equal monthly installments until the maturity date of July 1, 2019. The Note Agreement requires payment of a final fee of 4.75% of the aggregate original principal of amounts borrowed, which the Company is accruing over the term of the Note Agreement. In addition, amounts borrowed may be prepaid at the option of the Company in denominations of not less than $1.0 million, and any amounts prepaid are subject to a prepayment premium of 1.5% if prepaid prior to the first anniversary of the borrowing date, 1.0% if prepaid prior to the second anniversary of the borrowing date and after the first anniversary of the borrowing date, and 0.5% if prepaid prior to the maturity date and after the second anniversary of the borrowing date. The effective interest rate for the Note Agreement, including final fee interest and non-cash interest, is 9.4%. The Note Agreement does not include any financial covenants, but does contain a subjective acceleration clause whereby upon an event of default, which includes a material adverse change in the business, operations, or conditions (financial or otherwise) of the Company or a material impairment of the prospect of repayment of any portion of the obligations, the lender may accelerate the Company’s repayment obligations under the Note Agreement. In the event of default, the lender has first priority to substantially all of the Company’s assets. The lender has not exercised its right under this clause, as there have been no such events. The Company believes the likelihood of the lender exercising this right is remote. The Company assessed all terms and features of the Note Agreement in order to identify any potential embedded features that would require bifurcation or any beneficial conversion features. As part of this analysis, the Company assessed the economic characteristics and risks of the Note Agreement, including put and call features. The Company determined that all features of the Note Agreement are clearly and closely associated with a debt host and do not require bifurcation as a derivative liability, or the fair value of the feature is immaterial. The Company will continue to reassess the features to determine if they require separate accounting on a quarterly basis. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2015 | |
Stockholders' Equity | |
Stockholders' Equity | 6. Stockholders’ Equity Stock-Based Compensation 2006 Stock Incentive Plan The Company’s 2006 Stock Option Plan (“2006 Plan”) was established for granting stock incentive awards to directors, officers, employees and consultants of the Company. Upon closing of the Company’s IPO in August 2014, the Company ceased granting stock incentive awards under the 2006 Plan. The 2006 Plan provided for the grant of incentive and non-qualified stock options and restricted stock grants as determined by the Company’s board of directors. Under the 2006 Plan, stock options were generally granted with exercise prices equal to or greater than the fair value of the common stock as determined by the board of directors, expired no later than 10 years from the date of grant, and vest over various periods not exceeding 4 years. 2014 Stock Incentive Plan The Company’s 2014 Plan (“2014 Plan”, and together with the 2006 Plan, the “Plans”) provides for the issuance of shares of common stock in the form of stock options, awards of restricted stock, awards of restricted stock units, performance awards, dividend equivalent awards, stock payment awards and stock appreciation rights to directors, officers, employees and consultants of the Company. Since the establishment of the 2014 Plan, the Company has only granted stock options. Generally, stock options are granted with exercise prices equal to or greater than the fair value of the common stock on the date of grant, expire no later than 10 years from the date of grant, and vest over various periods not exceeding 4 years. The number of shares reserved for future issuance under the 2014 Plan is the sum of (1) 823,529 shares, (2) any shares that were granted under the 2006 Plan which are forfeited, lapsed unexercised or are settled in cash subsequent to the effective date of the 2014 Plan and (3) an annual increase on the first day of each calendar year beginning January 1, 2015 and ending on January 1, 2024, equal to the lesser of (A) 823,529 shares, (B) 4% of the shares outstanding (on an as-converted basis) on the final day of the immediately preceding calendar year, and (C) such smaller number of shares determined by the Company’s board of directors. As of June 30, 2015 there were 725,086 shares available for future grant under the 2014 Plan. Stock Options During the six months ended June 30, 2015, the Company granted options with an aggregate fair value of $6.7 million, which are being amortized into compensation expense over the vesting period of the options as the services are being provided. The following is a summary of option activity under the Plans: Number of Shares Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term (In years) Aggregate Intrinsic Value (In thousands) Outstanding at December 31, 2014 $ $ Granted Exercised ) Cancelled ) Outstanding at June 30, 2015 Exercisable at June 30, 2015 Vested or expected to vest at June 30, 2015 The total grant date fair values of stock options that vested during the six months ended June 30, 2015 and 2014 was $1.2 million and $359,000, respectively. The weighted-average fair values of options granted in the six-month periods ended June 30, 2015 and 2014 were $9.53 per share and $6.00 per share, respectively, and were calculated using the following estimated assumptions: Six Months Ended June 30, 2015 2014 Weighted-average risk-free interest rate Expected dividend yield Expected volatility Expected terms 5.9 years 6.0 years Employee Stock Purchase Plan The Company’s 2014 Employee Stock Purchase Plan (the “2014 ESPP”) provides initially for granting up to 220,588 shares of the Company’s common stock to eligible employees. The 2014 ESPP plan period is semi-annual and allows participants to purchase the Company’s common stock at 85% of the lower of (i) the market value per share of common stock on the first day of the offering period or (ii) the market value per share of the common stock on the purchase date. Each participant can purchase up to a maximum of $25,000 per calendar year in fair market value of such shares of common stock, as determined by the market value per share of common stock at the beginning of the offering period. The Company issued 33,224 shares of common stock for total proceeds of $404,000 upon completion of the offering period ended April 30, 2015. The current offering period commenced on May 1, 2015 and ends November 15, 2015. Stock-based compensation expense from the 2014 ESPP for the three and six-months ended June 30, 2015 was $68,000 and $128,000, respectively. Stock-Based Compensation Expense The following table summarizes the stock-based compensation expense resulting from awards granted under stock incentive plans, including the 2014 ESPP, that was recorded in the Company’s results of operations for the periods presented (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Research and development $ $ $ $ Selling, general and administrative Total stock-based compensation expense $ $ $ $ As of June 30, 2015, there was $11.5 million of total unrecognized compensation cost related to unvested stock options granted under the Plans. Total unrecognized compensation cost will be adjusted for future changes in the estimated forfeiture rate. The Company expects to recognize that cost over a remaining weighted-average period of 3.0 years as of June 30, 2015. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2015 | |
Net Loss Per Share | |
Net Loss Per Share | 7. Net Loss Per Share The following shares were excluded from the calculation of diluted net loss per share applicable to common stockholders, prior to the application of the treasury stock method, because the effect of including such shares would have been anti-dilutive for the periods presented: Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Redeemable convertible preferred stock — — Options to purchase common shares Warrants to purchase redeemable convertible preferred stock — — Total |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2015 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 8. Commitments and Contingencies Lease Amendments In May 2015, the Company entered into an amendment to a lease to expand existing manufacturing facilities. The lease amendment term is June 1, 2015 to December 31, 2017, and the annual rent for the expansion space is $66,000. In May 2015, the Company entered into an amendment to a lease to extend the term of the lease for office and laboratory space at the Company’s headquarters in Lexington, MA. The lease term will now extend from December 31, 2015 to December 31, 2017. The annual rent for the extension period is $1.1 million for 2016 and $1.2 million for 2017. In April 2015, the Company entered into an amendment to extend the term of an office space lease. The lease amendment extends the lease term from December 31, 2016 to December 31, 2017 and the annual rent for the additional year is approximately $300,000. |
Co-Development Agreement with C
Co-Development Agreement with Canon US Life Sciences | 6 Months Ended |
Jun. 30, 2015 | |
Co-Development Agreement with Canon US Life Sciences | |
Co-Development Agreement with Canon US Life Sciences | 9. Co-Development Agreement with Canon US Life Sciences On February 3, 2015, the Company entered into a Co-Development Partnership Agreement (the “Co-Development Agreement”) with Canon U.S. Life Sciences, Inc. (“Canon US Life Sciences”) to develop a diagnostic test panel to rapidly detect Lyme disease. Under the terms of the Co-Development Agreement, the Company received an upfront payment of $2.0 million from Canon US Life Sciences and may receive an additional $6.5 million of consideration upon achieving certain development and regulatory milestones for total aggregate payments of up to $8.5 million. The next payment the Company is eligible to receive is $1.5 million related to the achievement of a specified technical requirement. All payments under the Co-Development Agreement are non-refundable once received. The Company will retain exclusive worldwide commercialization rights of any products developed under the Co-Development Agreement, including sales, marketing and distribution and Canon US Life Sciences will not receive any commercial right and will be entitled to only receive royalty payments on the sales of all products developed under the Co-Development Agreement. Either party may terminate the Co-Development Agreement upon the occurrence of a material breach by the other party (subject to a cure period). The Company evaluated the deliverables under the Co-Development Agreement and determined that the Co-Development Agreement included one unit of accounting, the research and development services, as the joint research and development committee deliverable was deemed to be diminimus. The Company will recognize revenue for research and development services as a component of research revenue in the condensed consolidated financial statements as the services are delivered using the proportional performance method of accounting, limited to payments earned. Costs incurred to deliver the services under the Co-Development Agreement are recorded as research and development expense in the condensed consolidated financial statements. The Company recorded revenue of $324,000 and $377,000 during the three and six months ended June 30, 2015, respectively, under this Agreement. |
Summary of Significant Accoun15
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2015 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The Company’s financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as defined in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, T2 Biosystems Securities Corporation. All intercompany balances and transactions have been eliminated. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. The accompanying interim condensed consolidated balance sheet as of June 30, 2015, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2015 and 2014, the condensed consolidated statements of cash flows for the six months ended June 30, 2015 and 2014 and the related financial data and other information disclosed in these notes are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2015, and the results of its operations and its cash flows for the three and six months ended June 30, 2015 and 2014. The results for the three and six months ended June 30, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015, any other interim periods, or any future year or period. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company views its operations and manages its business in one operating segment, which is the business of developing and, upon regulatory clearance, launching commercially its diagnostic products aimed at reducing mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss applicable to common stockholders, which is net loss plus accretion of redeemable convertible preferred stock to redemption value in the period, by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method for outstanding stock options and warrants. For purposes of the diluted net loss per share calculation, redeemable convertible preferred stock, warrants to purchase redeemable convertible preferred stock and stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect, including the related impact to the numerator of the fair value adjustment of the warrant and the impact to the denominator of the warrant shares, would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders was the same for all periods presented. |
Guarantees | Guarantees From time to time, the Company enters into indemnification agreements in the ordinary course of business, including, but not limited to, indemnification agreements with directors and officers, within its lease agreements for office, laboratory and manufacturing space, and with certain suppliers and business partners. As of June 30, 2015 and December 31, 2014, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. |
Revenue Recognition | Revenue Recognition The Company generates revenue from product sales and research and development agreements with third parties. The Company recognizes revenue in accordance with FASB ASC Topic 605, Revenue Recognition (“ASC 605”). Accordingly, the Company recognizes revenue when all of the following criteria have been met: i. Persuasive evidence of an arrangement exists ii. Delivery has occurred or services have been rendered iii. The seller’s price to the buyer is fixed or determinable iv. Collectability is reasonably assured Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue. The Company offers customers the choice either to purchase a T2Dx outright or to allow the placement of a Company-owned T2Dx at the customer site pursuant to a “reagent rental” agreement. Revenue earned from activities performed pursuant to research and development agreements is reported as research revenue in the statements of operations and comprehensive loss, using the proportional performance method as the work is completed, limited to payments earned, and the related costs are expensed as incurred as research and development expense. The timing of receipt of cash from the Company’s research and development agreements generally differs from when revenue is recognized. For multiple-element arrangements, the Company identifies the deliverables included within each agreement and evaluates which deliverables represent separate units of accounting. The Company accounts for those components as separate elements when the following criteria are met: (1) the delivered items have value to the customer on a stand-alone basis; and, (2) if there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within its control. The consideration received is allocated among the separate units of accounting based on management’s best estimate of selling price, and the applicable revenue recognition criteria are applied to each of the separate units. The determination that multiple elements in an arrangement meet the criteria for separate units of accounting requires the Company’s management to exercise its judgment. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory (“ASU 2015-11”) The standard simplifies the subsequent measurement of inventory by requiring inventory to be measured at the lower of cost and net realizable value for entities using the first-in-first out method of valuing inventory. ASU 2015-11 eliminates other measures required by current guidance to determine net realizable value. ASU 2015-11 is effective for fiscal years beginning after December 15, 2016 and interim periods within those fiscal years and early adoption is permitted. The Company has not adopted ASU 2015-11 and does not expect the new guidance to have a material effect on its condensed consolidated financial statements. In April 2015, the FASB issued ASU No. 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement (“ASU 2015-05”). The standard clarifies that customers in cloud computing arrangements should determine whether the arrangement includes a license of software by applying the same guidance as cloud service providers and eliminates the existing requirement for customers to account for software licenses acquired by analogizing to the guidance on leases. It is effective for annual periods beginning on or after December 15, 2015, including interim periods within those annual periods, and early adoption is permitted. Adoption of ASU 2015-05 can either be applied (1) prospectively to all arrangements entered into or materially modified after the effective date or (2) retrospectively. The Company has not adopted the guidance prescribed by ASU 2015-05 and does not expect the new guidance to have a material effect on its condensed consolidated financial statements. In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs (“ASU 2015-03”). This standard amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. It is effective for annual reporting periods beginning after December 15, 2015, but early adoption is permitted. Adoption of ASU 2015-03 is applied retrospectively. The Company has not adopted the guidance prescribed by ASU 2015-03 and does not expect the new guidance to have a material effect on its condensed consolidated financial statements. In June 2014, the FASB issued amended guidance, ASU No. 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”), which is applicable to revenue recognition that will now be effective for the Company for the year ending December 31, 2018, as a result of the deferral of the effective date adopted by the FASB in July 2015. The new guidance must be adopted using either a full retrospective approach for all periods presented or a modified retrospective approach. Early adoption prior to the original adoption date of ASU 2014-09 is not permitted. The new guidance applies a more principles-based approach to revenue recognition. The Company is evaluating the new guidance and the expected effect on the Company’s condensed consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Fair Value Measurements | |
Schedule of financial assets and liabilities at fair value on a recurring basis | The following tables set forth the Company’s financial assets carried at fair value categorized using the lowest level of input applicable to each financial instrument as of June 30, 2015 and December 31, 2014 (in thousands): Balance at June 30, 2015 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Cash $ $ $ — $ — Money market funds — — Restricted cash — — $ $ $ — $ — Balance at December 31, 2014 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Cash $ $ $ — $ — Money market funds — — Restricted cash — — $ $ $ — $ — |
Supplemental Balance Sheet In17
Supplemental Balance Sheet Information (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Supplemental Balance Sheet Information | |
Schedule of inventory | Inventories are stated at the lower of cost or market value on a first-in, first-out basis and are comprised of the following (in thousands): June 30, December 31, 2015 2014 Raw materials $ $ Work-in-process Finished goods — Total inventories $ $ |
Schedule of property and equipment | Property and equipment consists of the following (in thousands): June 30, 2015 December 31, 2014 Office and computer equipment $ $ Software Laboratory equipment Furniture Manufacturing tooling and molds Leasehold improvements T2Dx Instruments and components Construction in progress Less accumulated depreciation and amortization ) ) Property and equipment, net $ $ |
Components of accrued expenses | Accrued expenses consist of the following (in thousands): June 30, December 31, 2015 2014 Accrued payroll and compensation $ $ Accrued research and development expenses Accrued professional services Other accrued expenses Total accrued expenses $ $ |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Stockholders' Equity | |
Summary of stock option activity | Number of Shares Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term (In years) Aggregate Intrinsic Value (In thousands) Outstanding at December 31, 2014 $ $ Granted Exercised ) Cancelled ) Outstanding at June 30, 2015 Exercisable at June 30, 2015 Vested or expected to vest at June 30, 2015 |
Schedule of estimated assumptions used to calculate weighted-average fair value of options granted | Six Months Ended June 30, 2015 2014 Weighted-average risk-free interest rate Expected dividend yield Expected volatility Expected terms 5.9 years 6.0 years |
Summary of stock-based compensation expense for stock options granted that was recorded in the Company's results of operations | The following table summarizes the stock-based compensation expense resulting from awards granted under stock incentive plans, including the 2014 ESPP, that was recorded in the Company’s results of operations for the periods presented (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Research and development $ $ $ $ Selling, general and administrative Total stock-based compensation expense $ $ $ $ |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Net Loss Per Share | |
Schedule of shares excluded from the calculation where the inclusion would be anti-dilutive | Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Redeemable convertible preferred stock — — Options to purchase common shares Warrants to purchase redeemable convertible preferred stock — — Total |
Nature of Business (Details)
Nature of Business (Details) - USD ($) $ in Thousands | Aug. 12, 2014 | Jun. 30, 2015 | Dec. 31, 2014 | Jul. 11, 2014 | Jun. 30, 2014 | Dec. 31, 2013 |
Cash and cash equivalents | $ 53,289 | $ 73,849 | $ 15,876 | $ 30,198 | ||
Accumulated deficit | $ (125,209) | $ (103,595) | ||||
Period over which cash resources will be sufficient to allow Company to fund current operating plan | 12 months | |||||
Note Agreement 1 | ||||||
Remaining borrowing capacity | $ 10,000 |
Summary of Significant Accoun21
Summary of Significant Accounting Policies (Details) | 6 Months Ended |
Jun. 30, 2015segment | |
Segment Information | |
Number of Operating Segments | 1 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - Fair value - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Assets: | ||
Restricted cash | $ 260 | $ 340 |
Total assets | 53,549 | 74,189 |
Cash | ||
Assets: | ||
Cash and cash equivalents | 1,287 | 10,348 |
Money market funds | ||
Assets: | ||
Cash and cash equivalents | 52,002 | 63,501 |
Level 1 | ||
Assets: | ||
Restricted cash | 260 | 340 |
Total assets | 53,549 | 74,189 |
Level 1 | Cash | ||
Assets: | ||
Cash and cash equivalents | 1,287 | 10,348 |
Level 1 | Money market funds | ||
Assets: | ||
Cash and cash equivalents | $ 52,002 | $ 63,501 |
Supplemental Balance Sheet In23
Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Supplemental Balance Sheet Information | ||
Raw materials | $ 265 | $ 71 |
Work-in-process | 219 | 44 |
Finished goods | 85 | |
Total inventories | $ 569 | $ 115 |
Supplemental Balance Sheet In24
Supplemental Balance Sheet Information (Details 2) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Property and Equipment | ||
Property and equipment, gross | $ 11,751 | $ 6,102 |
Accumulated depreciation and amortization | (3,942) | (3,342) |
Property and equipment, net | 7,809 | 2,760 |
Accrued expenses | ||
Accrued payroll and compensation | 1,885 | 1,846 |
Accrued research and development expenses | 296 | 733 |
Accrued professional services | 286 | 374 |
Other accrued expenses | 1,008 | 709 |
Total accrued expenses | 3,475 | 3,662 |
Office and computer equipment | ||
Property and Equipment | ||
Property and equipment, gross | 384 | 383 |
Software | ||
Property and Equipment | ||
Property and equipment, gross | 596 | 480 |
Laboratory equipment | ||
Property and Equipment | ||
Property and equipment, gross | 3,768 | 3,312 |
Furniture | ||
Property and Equipment | ||
Property and equipment, gross | 187 | 187 |
Manufacturing tooling and molds | ||
Property and Equipment | ||
Property and equipment, gross | 32 | 26 |
Leasehold improvements | ||
Property and Equipment | ||
Property and equipment, gross | 3,144 | 764 |
T2Dx instruments and components | ||
Property and Equipment | ||
Property and equipment, gross | 2,486 | 563 |
Construction in progress | ||
Property and Equipment | ||
Property and equipment, gross | $ 1,154 | $ 387 |
Debt (Details)
Debt (Details) - Note Agreement 1 $ in Millions | May. 27, 2015USD ($) | Jul. 11, 2014USD ($)trancheitem | Jun. 30, 2015USD ($) |
Debt Instrument [Line Items] | |||
Number of lenders | item | 2 | ||
Maximum borrowings available | $ 30 | ||
Number of tranches | tranche | 2 | ||
Remaining borrowing capacity | $ 10 | ||
Interest rate including both the variable rate and the basis spread (as a percent) | 7.24% | ||
Final fee as a percentage of original principal amount of amounts borrowed | 4.75% | ||
Minimum amount of denomination for prepayment of borrowings | $ 1 | ||
Effective interest rate including final fee interest and non-cash interest (as a percent) | 9.40% | ||
Prior to first anniversary of borrowing date | |||
Debt Instrument [Line Items] | |||
Prepayment premium (as a percent) | 1.50% | ||
Prior to second anniversary and after first anniversary of borrowing date | |||
Debt Instrument [Line Items] | |||
Prepayment premium (as a percent) | 1.00% | ||
Prior to maturity date and after second anniversary of borrowing date | |||
Debt Instrument [Line Items] | |||
Prepayment premium (as a percent) | 0.50% | ||
LIBOR | |||
Debt Instrument [Line Items] | |||
Variable Interest Rate | one-month LIBOR | ||
Basis spread (as a percent) | 7.05% | ||
Tranche A | |||
Debt Instrument [Line Items] | |||
Maximum borrowings available | $ 20 | ||
Minimum amount of draw upon closing | 10 | ||
Minimum amount of draw after closing | 5 | ||
Proceeds received on borrowing, net of deferred financing costs | $ 19.7 | ||
Tranche B | |||
Debt Instrument [Line Items] | |||
Maximum borrowings available | $ 10 | 10 | |
Minimum net proceeds to be received from stock offering, equity raise, or strategic partner arrangement to allow for borrowing | $ 30 | ||
Commitment fee on undrawn principal (as a percent) | 1.00% | ||
Remaining borrowing capacity | $ 10 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Apr. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | |
Share-Based Compensation | ||||||
Stock-based compensation expense | $ 855,000 | $ 266,000 | $ 1,577,000 | $ 505,000 | ||
Employee Stock Purchase Plan | ||||||
Share-Based Compensation | ||||||
Shares available for grant | 220,588 | 220,588 | ||||
Percentage of full share price paid in purchase of common stock | 85.00% | 85.00% | ||||
Maximum amount of annual employee common stock purchases | $ 25,000 | |||||
Shares issued under employee stock purchase plan | 33,224 | |||||
Proceeds from issuance of awards under employee stock purchase plan | $ 404,000 | |||||
Stock-based compensation expense | $ 68,000 | 128,000 | ||||
2006 and 2014 Stock Option Plans | Stock options | ||||||
Share-Based Compensation | ||||||
Aggregate fair value of options granted | $ 6,700,000 | |||||
Number of Shares | ||||||
Outstanding, beginning of the period (in shares) | 2,911,146 | |||||
Granted (in shares) | 699,983 | |||||
Exercised (in shares) | (241,053) | |||||
Cancelled (in shares) | (75,057) | |||||
Outstanding, end of the period (in shares) | 3,295,019 | 3,295,019 | 2,911,146 | |||
Exercisable (in shares) | 1,439,321 | 1,439,321 | ||||
Vested or expected to vest (in shares) | 3,069,705 | 3,069,705 | ||||
Weighted Average Exercise Price Per Share | ||||||
Outstanding, beginning of the period (in dollars per share) | $ 5.30 | |||||
Granted (in dollars per share) | 18.18 | |||||
Exercised (in dollars per share) | 2.88 | |||||
Cancelled (in dollars per share | 9.17 | |||||
Outstanding, end of the period (in dollars per share) | $ 8.12 | 8.12 | $ 5.30 | |||
Exercisable (in dollars per share) | 3.20 | 3.20 | ||||
Vested or expected to vest (in dollars per share) | $ 7.76 | $ 7.76 | ||||
Weighted-Average Remaining Contractual Term (in years) | ||||||
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2 | 7 years 11 months 9 days | 7 years 10 months 13 days | ||||
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2 | 7 years 11 months 9 days | 7 years 10 months 13 days | ||||
Exercisable (in years) | 6 years 6 months 22 days | |||||
Vested or expected to vest (in years) | 7 years 10 months 6 days | |||||
Aggregate Intrinsic Value | ||||||
Outstanding, beginning of the period | $ 40,586,000 | |||||
Exercised | 3,327,000 | |||||
Outstanding, end of the period | $ 28,833,000 | 28,833,000 | $ 40,586,000 | |||
Exercisable | 18,846,000 | 18,846,000 | ||||
Vested or expected to vest | $ 27,851,000 | $ 27,851,000 | ||||
Fair value assumptions | ||||||
Weighted average fair value of options granted (in dollars per share) | $ 9.53 | $ 6 | ||||
Weighted-average risk-free interest rate | 1.69% | 1.97% | ||||
Expected dividend yield | 0.00% | |||||
Expected volatility | 55.00% | 62.00% | ||||
Expected terms | 5 years 10 months 24 days | 6 years | ||||
Fair value of stock options vested | $ 1,200,000 | $ 359,000 | ||||
2014 Stock Option Plan | Stock options | ||||||
Share-Based Compensation | ||||||
Common stock were reserved for issuance | 823,529 | 823,529 | ||||
Shares available for grant | 725,086 | 725,086 | ||||
Percentage of common shares outstanding | 4.00% | |||||
2014 Stock Option Plan | Maximum | Stock options | ||||||
Share-Based Compensation | ||||||
Expiration Period | 10 years | |||||
Vesting period | 4 years | |||||
2006 Stock Option Plan | Maximum | Stock options | ||||||
Share-Based Compensation | ||||||
Expiration Period | 10 years | |||||
Vesting period | 4 years |
Stockholders' Equity (Details 2
Stockholders' Equity (Details 2) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 855 | $ 266 | $ 1,577 | $ 505 |
Total unrecognized compensation costs related to non-vested stock options | 11,500 | $ 11,500 | ||
Remaining weighted-average period that unrecognized compensation costs are expected to be recognized | 3 years | |||
Research and development | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 297 | 67 | $ 577 | 123 |
Selling, general and administrative | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 558 | $ 199 | $ 1,000 | $ 382 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Anti-dilutive securities | ||||
Anti-dilutive securities excluded from the computation of diluted net loss per share (in shares) | 3,295,019 | 15,011,988 | 3,295,019 | 15,011,988 |
Redeemable convertible preferred stock | ||||
Anti-dilutive securities | ||||
Anti-dilutive securities excluded from the computation of diluted net loss per share (in shares) | 12,516,298 | 12,516,298 | ||
Stock options | ||||
Anti-dilutive securities | ||||
Anti-dilutive securities excluded from the computation of diluted net loss per share (in shares) | 3,295,019 | 2,348,206 | 3,295,019 | 2,348,206 |
Warrants to purchase redeemable convertible preferred stock | ||||
Anti-dilutive securities | ||||
Anti-dilutive securities excluded from the computation of diluted net loss per share (in shares) | 147,484 | 147,484 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | May. 31, 2015 | Apr. 30, 2015 |
Operating lease entered into May 2015 | Manufacturing facility | ||
Leases | ||
Annual rent | $ 66,000 | |
Operating lease entered into May 2015 | Office and laboratory space | ||
Leases | ||
Annual rent for 2016 | 1,100,000 | |
Annual rent owed in 2017 | $ 1,200,000 | |
Operating leases entered into April 2015 | Office Space | ||
Leases | ||
Annual rent owed in 2017 | $ 300,000 |
Co-Development Agreement with30
Co-Development Agreement with Canon US Life Sciences (Details) | Feb. 03, 2015USD ($)item | Jun. 30, 2015USD ($) | Jun. 30, 2015USD ($) |
Co-Development Agreement with Canon US Life Sciences | |||
Revenues | $ 564,000 | $ 753,000 | |
Co Development Partnership Agreement | Canon U.S. Life Sciences Inc Member | |||
Co-Development Agreement with Canon US Life Sciences | |||
Upfront payment received | $ 2,000,000 | ||
Additional consideration receivable upon achievement of certain development and regulatory milestones | 6,500,000 | ||
Additional consideration receivable upon achievement of specified technical requirement | 1,500,000 | ||
Aggregate consideration receivable | $ 8,500,000 | ||
Number of units | item | 1 | ||
Revenues | $ 324,000 | $ 377,000 |