Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Oct. 24, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | TNDM | |
Entity Registrant Name | TANDEM DIABETES CARE INC | |
Entity Central Index Key | 1,438,133 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 57,369,283 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 32,327 | $ 13,700 |
Short-term investments | 81,254 | 479 |
Accounts receivable, net | 21,689 | 20,793 |
Inventory, net | 24,366 | 26,993 |
Prepaid and other current assets | 3,035 | 2,191 |
Total current assets | 162,671 | 64,156 |
Property and equipment, net | 17,582 | 19,631 |
Restricted cash—long term | 10,000 | |
Other long-term assets | 141 | 102 |
Total assets | 181,606 | 95,346 |
Current liabilities: | ||
Accounts payable | 6,198 | 5,150 |
Accrued expense | 3,931 | 2,832 |
Employee-related liabilities | 17,229 | 14,488 |
Deferred revenue | 3,703 | 2,526 |
Common stock warrants | 20,643 | 5,432 |
Other current liabilities | 6,846 | 5,657 |
Total current liabilities | 58,550 | 36,085 |
Notes payable—long-term | 76,541 | |
Deferred rent—long-term | 4,028 | 4,687 |
Other long-term liabilities | 3,599 | 7,181 |
Total liabilities | 66,177 | 124,494 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity (deficit): | ||
Common stock, $0.001 par value; 200,000 and 100,000 shares authorized as of September 30, 2018 and December 31, 2017, respectively. 57,364 and 10,119 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively. | 57 | 10 |
Additional paid-in capital | 719,148 | 448,455 |
Accumulated other comprehensive loss | (13) | |
Accumulated deficit | (603,763) | (477,613) |
Total stockholders’ equity (deficit) | 115,429 | (29,148) |
Total liabilities and stockholders’ equity (deficit) | 181,606 | 95,346 |
Patents [Member] | ||
Current assets: | ||
Patents, net | $ 1,212 | $ 1,457 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 100,000,000 |
Common stock, shares issued | 57,364,000 | 10,119,000 |
Common stock, shares outstanding | 57,364,000 | 10,119,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Income Statement [Abstract] | ||||
Sales | $ 46,264 | $ 27,003 | $ 107,667 | $ 67,306 |
Cost of sales | 24,468 | 15,131 | 59,381 | 40,680 |
Gross profit | 21,796 | 11,872 | 48,286 | 26,626 |
Operating expenses: | ||||
Selling, general and administrative | 29,506 | 20,125 | 73,048 | 65,077 |
Research and development | 7,999 | 4,914 | 20,430 | 14,910 |
Total operating expenses | 37,505 | 25,039 | 93,478 | 79,987 |
Operating loss | (15,709) | (13,167) | (45,192) | (53,361) |
Other income (expense), net: | ||||
Interest and other income | 443 | 60 | 833 | 179 |
Interest and other expense | (1,401) | (2,928) | (7,585) | (8,445) |
Loss on extinguishment of debt | (5,313) | (5,313) | ||
Change in fair value of stock warrants | (12,265) | (69,042) | ||
Total other expense, net | (18,536) | (2,868) | (81,107) | (8,266) |
Net loss | (34,245) | (16,035) | (126,299) | (61,627) |
Other comprehensive loss: | ||||
Unrealized gain (loss) on short-term investments | (19) | (13) | 1 | |
Comprehensive loss | $ (34,264) | $ (16,035) | $ (126,312) | $ (61,626) |
Net loss per share, basic and diluted | $ (0.62) | $ (3.09) | $ (2.81) | $ (13.79) |
Weighted average shares used to compute basic and diluted net loss per share | 55,615 | 5,190 | 44,993 | 4,468 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 27 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Operating activities | ||||
Net loss | $ (126,299) | $ (61,627) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Depreciation and amortization expense | 4,353 | 4,737 | ||
Interest expense related to amortization of debt discount and debt issuance costs | 1,721 | 1,338 | ||
Provision for allowance for doubtful accounts | 1,017 | 664 | ||
Provision for inventory reserve | 397 | 316 | ||
Payment in kind interest accrual of notes payable | 1,236 | $ 2,700 | ||
Change in fair value of common stock warrants | $ 12,265 | 69,042 | ||
Amortization of premium (discount) on short-term investments | 783 | (16) | ||
Stock-based compensation expense | 13,427 | 10,502 | ||
Loss on extinguishment of debt | 5,313 | 5,313 | ||
Other | 155 | 69 | ||
Changes in operating assets and liabilities: | ||||
Accounts receivable, net | (1,913) | (73) | ||
Inventory, net | 2,752 | (9,038) | ||
Prepaid and other current assets | (823) | 1,133 | ||
Other long-term assets | (39) | (53) | ||
Accounts payable | 1,083 | 522 | ||
Accrued expense | 1,098 | 907 | ||
Employee-related liabilities | 2,741 | 797 | ||
Deferred revenue | 1,178 | (4,137) | ||
Other current liabilities | 1,100 | (601) | ||
Deferred rent | (571) | (425) | ||
Other long-term liabilities | 1,033 | (746) | ||
Net cash used in operating activities | (22,452) | (54,495) | ||
Investing activities | ||||
Purchase of short-term investments | (100,550) | |||
Proceeds from sales and maturities of short-term investments | 18,500 | 8,500 | ||
Purchase of property and equipment | (2,098) | (4,299) | ||
Net cash provided by (used in) investing activities | (84,148) | 4,201 | ||
Financing activities | ||||
Principal payments on notes payable | (87,711) | |||
Proceeds from public offering, net of offering costs | 172,929 | 25,125 | ||
Proceeds from exercise of warrants | 29,536 | |||
Proceeds from common stock issued under employee benefit plans | 473 | 570 | ||
Net cash provided by financing activities | 115,227 | 25,695 | ||
Net increase (decrease) in cash and cash equivalents and restricted cash | 8,627 | (24,599) | ||
Cash and cash equivalents and restricted cash at beginning of period | 23,700 | 46,678 | ||
Cash and cash equivalents and restricted cash at end of period | $ 32,327 | 32,327 | 22,079 | $ 23,700 |
Supplemental disclosures of cash flow information | ||||
Interest paid | 5,841 | 5,871 | ||
Supplemental schedule of noncash investing and financing activities | ||||
Lease incentive - lessor-paid tenant improvements | 3,037 | |||
Debt discount included in other long-term liabilities | 6,720 | |||
Common stock warrants issued in connection with term loan | 3,331 | |||
Property and equipment included in accounts payable | $ 57 | $ 72 |
Organization and Basis of Prese
Organization and Basis of Presentation | 9 Months Ended |
Sep. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation The Company Tandem Diabetes Care, Inc. is a medical device company focused on the design, development and commercialization of products for people with insulin-dependent diabetes. The Company is incorporated in the state of Delaware. Unless the context requires otherwise, the terms the “Company” or “Tandem” refer to Tandem Diabetes Care, Inc. The Company manufactures and sells insulin pump products that are designed to address large and differentiated needs of the insulin-dependent diabetes market. The Company’s manufacturing and sales activities primarily focus on the t:slim X2 Insulin Delivery System (t:slim X2), the next-generation flagship product that is updatable and designed to display continuous glucose monitoring (CGM), sensor information directly on the pump Home Screen. The Company’s insulin pump products are generally considered durable medical equipment, and have an expected lifespan of at least four years. In addition to selling insulin pumps, the Company sells disposable products that are used together with the pumps and are replaced every few days, including cartridges for storing and delivering insulin, and infusion sets that connect the insulin pump to a user’s body. The Company’s insulin pump products are compatible with the Tandem Device Updater, . The Company began commercial sales of its first product, t:slim, in August 2012 and subsequently commercialized t:flex in May 2015, t:slim G4 in September 2015 and t:slim X2 in October 2016. T he t:slim X2 hardware platform now represents 100% of new pump shipments, but t In June 2018, the Company received approval by the United States Food and Drug Administration (FDA) for t:slim X2 with Basal-IQ technology, the Company’s first generation Automated Insulin Delivery (AID) algorithm, and commenced commercial sales of this product in August 2018. In August 2018, the Company commenced sales of the t:slim X2 in select geographies outside the United States. In July 2016, the Company launched a Technology Upgrade Program that provided eligible t:slim and t:slim G4 customers a path to obtain the t:slim X2 hardware platform. Participating customers had the right to exchange their original t:slim and t:slim G4 for a t:slim X2 under a variable pricing structure. The Technology Upgrade Program expired on September 30, 2017. The Company has incurred operating losses since its inception and, as reflected in the accompanying financial statements, the Company had an accumulated deficit of $603.8 million as of September 30, 2018, which included a net loss of $126.3 million for the nine months ended September 30, 2018. Management expects operating losses and negative cash flows to continue for at least the next 12 months. As of September 30, 2018, the Company had $113.6 million in cash and cash equivalents and short-term investments in marketable securities. Management believes that the cash and investments on hand will be sufficient to satisfy its liquidity requirements for at least the next 12 months. The Company’s ability to execute on its business strategy, meet its future liquidity requirements, and achieve and maintain profitable operations, is dependent on a number of factors, including its ability to continue to gain market acceptance of its products and achieve a level of revenues adequate to support its cost structure, achieve renewal pump sales objectives, develop and launch new products, increase gross profits from higher sales of infusion sets, maximize manufacturing efficiencies, satisfy increasing production requirements, leverage the investments made in its sales, clinical, marketing and customer support organizations and operate its business and manufacture and sell products without infringing third party intellectual property rights. The Company has funded its operations primarily through private and public equity and debt financing. The Company may in the future seek additional capital from public Basis of Presentation The Company has funded its operations primarily through private and public equity and debt financing. The Company may in the future seek additional capital from public Interim financial results are not necessarily indicative of results anticipated for the full year or any other period(s). These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and accompanying footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 (Annual Report), from which the balance sheet information herein was derived. These unaudited condensed consolidated financial statements exclude disclosures required by U.S. GAAP for complete financial statements. The condensed consolidated financial statements include the accounts of Tandem Diabetes Care, Inc. and its wholly owned subsidiary in Canada. All significant intercompany balances and transactions have been eliminated in consolidation. Reclassifications Certain reclassifications of prior year amounts have been made to conform to the current year presentation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies There have been no material changes in our significant accounting policies during the nine months ended September 30, 2018, as compared with those disclosed in the Annual Report other than adoption of the new revenue recognition standard (Revenue from Contracts with Customers Standard) Use of Estimates The preparation of the financial statements in conformity with U.S. GAAP requires management to make informed estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying footnotes as of the date of the financial statements. Actual results could materially differ from those estimates and assumptions. Segment Reporting Operating segments are identified as components of an enterprise about which discrete financial information is available for evaluation by the chief operating decision-maker (CODM) in making decisions regarding resource allocation and assessing performance. The Company’s current product offering consists primarily of . s key operating decisions and resource allocations are made by the CODM using consolidated financial data Restricted Cash The Company recorded $10.0 million of restricted cash as of December 31, 2017, for the minimum cash balance requirement in connection with the Amended and Restated Term Loan Agreement (Term Loan Agreement) with Capital Royalty Partners II, L.P. and its affiliated funds (CRG) (see Note 6, Term Loan Agreement). Due to the full repayment of the term loan in August 2018, no restricted cash balance existed at September 30, 2018. In January 2018, the Company adopted new guidance from the Financial Accounting Standards Board (FASB) Accounts Receivable The Company grants credit to various customers in the ordinary course of business. The Company maintains an allowance for doubtful accounts for potential credit losses. Provisions are made based on historical experience, assessment of specific risk, review of outstanding invoices, and various assumptions and estimates that are believed to be reasonable under the circumstances. Uncollectible accounts are written off against the allowance after appropriate collection efforts have been exhausted and when it is deemed that a balance is uncollectible. Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, accrued expense, and employee-related liabilities are reasonable estimates of their fair values because of the short-term nature of these assets and liabilities. Short-term investments The estimated fair value of certain of the Company’s common stock warrants is determined using the Black-Scholes pricing model as of September 30, 2018 and December 31, 2017 (see Note 5, “Fair Value Measurements”) . Revenue Recognition Revenue is generated primarily from sales of insulin pumps, disposable cartridges and infusion sets to individual customers and third-party distributors that resell the product to insulin-dependent diabetes customers. The Company is paid directly by customers who use the products, distributors and third-party insurance payors. In January 2018, the Company adopted the Revenue from Contracts with Customers Standard which supersedes existing revenue guidance under U.S. GAAP and International Financial Reporting Standards. Pursuant to the Revenue from Contracts with Customers Standard’s core principle, subsequent to January 1, 2018, the Company recognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The Company elected to implement this new standard utilizing the modified retrospective method. Under this approach, the Company applied the new standard to all new contracts initiated on or after the effective date, and, for contracts which had remaining obligations as of the effective date, the Company recorded an adjustment to the opening balance of accumulated deficit. The accounting for the significant majority of the Company’s revenues is not impacted by the new guidance. As a result, on January 1, 2018, the Company recorded a net reduction to accumulated deficit in the amount of $149,000, reflecting the accounting change. Prior to the implementation of this new standard, revenue was recognized when persuasive evidence of an arrangement existed, delivery had occurred and title passed, the price was fixed or determinable, and collectability was reasonably assured. The Company At September 30, 2018 and December 31, 2017, $2.7 million and $2.0 million, respectively, were recorded as deferred revenue for these performance obligations that are satisfied over time. Additionally, the Company offers a 30-day right of return to its customers from the date of shipment of any of its insulin pumps, provided a physician’s confirmation of the medical reason for the return is received. Estimated allowances for sales returns are based on historical returned quantities as compared to pump shipments in those same periods of return. The return rate is then applied to the sales of the current period to establish a reserve at the end of the period. The return rates used in the reserve are adjusted for known or expected changes in the marketplace when appropriate. Under the new guidance, the allowance for product returns is recorded as a reduction of revenue and an increase in deferred revenue in the period in which the related sale is recorded. Historically, the allowance was recorded as a reduction of revenue and accounts receivable. The amount recorded on the Company’s balance sheets for product return allowance was Warranty Reserve The Company generally provides a four-year warranty on its insulin pumps to end user customers and may replace any pumps that do not function in accordance with the product specifications. Insulin pumps returned to the Company may be refurbished and redeployed. The Company evaluates the reserve quarterly and makes adjustments when appropriate. Changes to the actual replacement rates or the expected product replacement cost could have a material impact on the Company’s estimated warranty reserve. As of September 30, 2018 and December 31, 2017, the warranty reserve was $7.7 million and $5.6 million, respectively. The following table provides a reconciliation of the change in product warranty liabilities from December 31, 2017 through September 30, 2018 (in thousands): Balance at December 31, 2017 $ 5,640 Provision for warranties issued during the period 5,570 Settlements made during the period (5,741 ) Increases in warranty estimates 2,267 Balance at September 30, 2018 $ 7,736 Current portion $ 4,137 Non-current portion 3,599 Total $ 7,736 Stock-Based Compensation Stock-based compensation cost is measured at the grant date based on the estimated fair value of the award, and the portion that is ultimately expected to vest is recognized as compensation expense over the requisite service period on a straight-line basis. The Company estimates the fair value of stock options issued under the Company’s 2013 Stock Incentive Plan (“2013 Plan”) and shares issued under the Company’s 2013 Employee Stock Purchase Plan (“ESPP”) using a Black-Scholes option-pricing model on the date of grant. The Black-Scholes option-pricing model requires the use of subjective assumptions about a number of key variables, including stock price volatility, expected term, and risk-free interest rate. For awards that vest based on the achievement of service conditions, the Company recognizes expense using the straight-line method less estimated forfeitures based on historical experience. Net Loss Per Share Basic net loss per share Potentially dilutive securities not included in the calculation of diluted net loss per share (because inclusion would be anti-dilutive) are as follows (in thousands, in common stock equivalent shares): Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Warrants for common stock 710 - 710 - Common stock options 5,155 8 3,031 3 ESPP 61 - 24 - 5,926 8 3,765 3 Recent Accounting Pronouncements In February 2016, the FASB issued final guidance for lease accounting. The new accounting standard requires lessees to recognize right-of-use assets and corresponding lease liabilities for all leases with lease terms of greater than twelve months. It also changes the definition of a lease and expands the disclosure requirements of lease arrangements. In July 2018, the FASB added a transition option for implementation that allows companies to continue to use the legacy guidance in ASC 840, Leases, including its disclosure requirements, in the comparative periods presented in the year of adoption of the new leases standard. The new accounting standard must be adopted using the modified retrospective approach and will be effective for the Company starting in the first quarter of fiscal 2019. Companies that elect the transition option will record a cumulative-effect adjustment to retained earnings in the period of adoption rather than the earliest period presented. expects that the adoption of this standard will result in a material increase in assets and liabilities on its consolidated balance sheets and In June 2016, the FASB issued an accounting standards update that changes the measurement and recognition of credit losses for most financial assets and certain other instruments. The new standard requires the use of forward-looking expected credit loss models based on historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount, which may result in earlier recognition of credit losses under the new standard. The standard is effective for public business entities for annual periods beginning after December 15, 2019, and interim periods within those years. The Company plans to implement the new standard in the first quarter of fiscal 2020, and is in the process of reviewing its credit loss models to assess the impact of the adoption of the standard on its financial statements. In March 2018, the FASB issued Accounting Standards Update No. 2018-05, Income taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 Income Tax Accounting Implications of the Tax Cuts and Jobs Act. The Company recognized the income tax effects of the 2017 Tax Act in its 2017 financial statements for which the accounting under ASC Topic 740 is incomplete, but a reasonable estimate could be determined. The tax effects of certain provisions of the 2017 Tax Act, such as the deductibility of compensation in excess of $1 million for certain employees, and limitations on executive compensation, requires further analysis. The Company is in the process of assessing the impact of the adoption of the standard on its financial statements. In August 2018, the FASB issued ASU 2018-15 that changes the accounting for implementation costs incurred in a cloud computing arrangement that is a service contract. ASU 2018-15 aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The implementation costs should be presented as a prepaid asset in the balance sheet and expensed over the term of the hosting arrangement. The standard is effective for annual periods, including interim periods within those annual periods, beginning after December 15, 2019. Early adoption is permitted. The Company is in the process of assessing the impact of the adoption of the standard on its financial statements. |
Short-Term Investments
Short-Term Investments | 9 Months Ended |
Sep. 30, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Short-Term Investments | 3. Short-Term Investments The Company invests in investment securities, principally debt instruments of financial institutions and corporations with strong credit ratings. The following represents a summary of the estimated fair value of short-term investments as of September 30, 2018 and December 31, 2017 (in thousands): At September 30, 2018 Maturity (in years) Amortized Cost Unrealized Gain Unrealized Loss Estimated Fair Value Available-for-sale investment securities: Commercial paper Less than 1 $ 65,654 $ 1 $ (14 ) $ 65,641 U.S. Treasury securities Less than 1 15,613 — — 15,613 Total $ 81,267 $ 1 $ (14 ) $ 81,254 At December 31, 2017 Maturity (in years) Amortized Cost Unrealized Gain Unrealized Loss Estimated Fair Value Trading securities: Mutual funds held for nonqualified deferred compensation plan participants $ 459 $ 20 $ — $ 479 Total $ 459 $ 20 $ — $ 479 |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2018 | |
Inventory Disclosure [Abstract] | |
Inventory | 4. Inventory Inventory consisted of the following as of September 30, 2018 and December 31, 2017 (in thousands): September 30, December 31, 2018 2017 Raw materials $ 8,609 $ 10,328 Work-in-process 4,489 3,812 Finished goods 11,268 12,853 Total $ 24,366 $ 26,993 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements Authoritative guidance on fair value measurements defines fair value, establishes a consistent framework for measuring fair value, and expands disclosures for each major asset and liability category measured at fair value on either a recurring or a nonrecurring basis. Fair value is intended to reflect an assumed exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the authoritative guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities . Level 2: Inputs, other than quoted prices in active markets, that are observable either directly or indirectly for substantially the full term of the asset or liability . Level 3: Unobservable inputs in which there is little or no market data and that are significant to the fair value of the assets or liabilities, which require the reporting entity to develop its own valuation techniques that require input assumptions . The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2018 and December 31, 2017, and indicates the fair value hierarchy of the valuation techniques utilized by the Company to determine such fair value (in thousands): Fair Value Measurements at September 30, 2018 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (1) $ 28,104 $ 28,104 $ — $ — Commercial paper 65,641 — 65,641 — U.S. Treasury securities 15,613 15,613 — — Total assets $ 109,358 $ 43,717 $ 65,641 $ — Liabilities Common stock warrants $ 20,643 $ — $ — $ 20,643 Total liabilities $ 20,643 $ — $ — $ 20,643 Fair Value Measurements at December 31, 2017 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (1) $ 23,700 $ 23,700 $ — $ — Mutual funds held for nonqualified deferred compensation plan participants (2) 479 479 — — Total assets $ 24,179 $ 24,179 $ — $ — Liabilities Common stock warrants $ 5,432 $ — $ — $ 5,432 Deferred compensation (2) 479 479 — - Total liabilities $ 5,911 $ 479 $ — $ 5,432 (1) Generally, cash equivalents include money market funds and investments with a maturity of three months or less from the date of purchase. This asset is included as a component of cash and cash equivalents on the balance sheet, of which $10.0 million was classified as restricted cash – long-term as of December 31, 2017. (2) The deferred compensation plan was directed by the Company and structured as a Rabbi Trust for the benefit of certain executives and non-employee directors. The investment assets of the Rabbi Trust were valued using quoted market prices multiplied by the number of shares held in each trust account. The related deferred compensation liability represents the fair value of the investment assets . The Company cancelled the deferred compensation plan in 2017 and all deferred compensation amounts were distributed to participants during the second quarter of 2018. The Company’s Level 2 financial instruments are valued using market prices on less active markets with observable valuation inputs such as interest rates and yield curves. The Company obtains the fair value of Level 2 financial instruments from quoted market prices, calculated prices or quotes from third-party pricing services. The Company validates these prices through independent valuation testing and review of portfolio valuations provided by the Company’s investment managers. There were no transfers between Level 1 and Level 2 assets during the nine months ended September 30, 2018. The Company’s Level 3 liabilities at September 30, 2018 included the Series A warrants issued by the Company in connection with its public offering of common stock in October 2017. Level 3 liabilities at December 31, 2017 included the Series A and Series B warrants issued by the Company in connection with the October 2017 offering. The Series A warrants have a term of five years and initially provided holders the right to purchase 4,630,000 shares of the Company’s common stock at an exercise price of $3.50 per share. The Series B warrants had a term of six months and initially provided holders the right to purchase 4,630,000 shares of the Company’s common stock at an exercise price of $3.50 per share. The Series A and Series B warrants were initially valued in the aggregate amount of $6.5 million on the date of issuance utilizing a Black-Scholes pricing model. As of September 30, 2018, there were Series A warrants to purchase 516,030 shares of common stock outstanding and no Series B warrants outstanding (see Note 7, “Stockholders’ Equity”). The Company reassesses the fair value of the outstanding Series A and Series B warrants at each reporting date utilizing a Black-Scholes pricing model. Inputs used in the pricing model include estimates of stock price volatility, expected warrant life and risk-free interest rate. The Company develops its estimates based on publicly available historical data. The assumptions used to estimate the fair values of the common stock warrants at September 30, 2018 and December 31, 2017 are presented below: Series A Warrants September 30, 2018 December 31, 2017 Risk-free interest rate 2.9 % 2.2 % Expected dividend yield 0.0 % 0.0 % Expected volatility 77.6 % 63.5 % Expected term (in years) 4.1 4.8 Series B Warrants September 30, 2018 (1) December 31, 2017 Risk-free interest rate N/A 1.4 % Expected dividend yield N/A 0.0 % Expected volatility N/A 80.3 % Expected term (in years) N/A 0.3 (1) As of September 30, 2018, there were no Series B warrants outstanding. The following table presents a summary of changes in the fair value of the Company’s Level 3 financial assets for the nine months ended September 30, 2018: Balance at December 31, 2017 $ 5,432 Increase in fair value included in change in fair value of common stock warrants 69,042 Decrease in fair value from warrants exercised during the period (53,831 ) Balance at September 30, 2018 $ 20,643 During the nine months ended September 30, 2018, the Company issued 8,598,076 shares of common stock upon the exercise of Series A and Series B warrants and 13,450 Series B warrants expired unexercised. As a result, there were 516,030 Series A warrants to purchase common stock outstanding as of September 30, 2018. |
Term Loan Agreement
Term Loan Agreement | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
Term Loan Agreement | 6. Term Loan Agreement In August 2018, the Company fully repaid the term loan made by CRG pursuant to the Term Loan Agreement. The term loan was collateralized by all assets of the Company. The balance of the outstanding debt at the time of repayment was $82.7 million. The repayment included approximately $1.1 million in accrued interest and $5.0 million in associated financing fees that became due. As a result of the repayment, the Company did not have any borrowings outstanding under the Term Loan Agreement as of September 30, 2018. The Company had aggregate borrowings under the Term Loan Agreement of $82.7 million as of December 31, 2017. Notes payable-long term on the accompanying consolidated balance sheet reflected these aggregate borrowings, offset by a $6.2 million debt discount associated with the financing fees and certain debt issuance costs at December 31, 2017. Such discounts were amortized to interest expense over the term of the loan using the effective interest method. At the time of repayment, the remaining balance of $5.3 million was accelerated and recognized as a loss on extinguishment of debt in the consolidated statement of operations in the third quarter ended September 30, 2018. Under the Term Loan Agreement, interest was payable at the Company’s option, (i) in cash at a rate of 11.5% per annum, or (ii) at a rate of 9.5% of the 11.5% per annum in cash and 2.0% of the 11.5% per annum (the “PIK Loan”) to be added to the principal of the loan and subject to accruing interest. Interest-only payments were due quarterly on March 31, June 30, September 30 and December 31 of each year of the interest-only payment period, which would have ended on December 31, 2019. The principal balance was due in full at the end of the term of the loan, which was March 31, 2020 (the “Maturity Date”). The Company had elected to pay interest in cash at a rate of 11.5% per annum through September 30, 2015. From October 1, 2015 through December 31, 2017, the Company elected to pay interest in cash at a rate of 9.5% per annum and for a rate of 2.0% per annum to be added to the principal of the loan. As a result, $2.7 million was added to the principal of the loan during that time period (the “PIK Loans”). The Company entered into a series of amendments to the Term Loan Agreement in 2016, 2017 and 2018, which included the addition of a financing fee payable at the maturity of the Company’s loans, the issuance of 193,788 ten-year warrants to CRG to purchase shares of the Company’s common stock at an exercise price of $23.50 per share and certain other minimum financing covenants. The financing fee was applicable to the entire aggregate principal amount of borrowings outstanding, including total PIK Loans issued. The Company treated the execution of each of the Third, Fourth and Fifth Amendments as a modification for accounting purposes. The present value of the future cash flows under these amendments did not exceed the present value of the future cash flows under the previous terms by more than 10%. At December 31, 2017, the Company had accrued $4.1 million for the financing fee of 5%, which was subsequently increased to $5.0 million, or 6%, in February 2018. These fees were included in other long-term liabilities and as contra-debt in notes payable-long term on the accompanying consolidated balance sheet. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | 7. Stockholders’ Equity Public Offerings In the first quarter of 2017, the Company completed a public offering of 1,850,000 shares of its common stock at a public offering price of $12.50 per share. The gross proceeds to the Company from the offering were $23.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. From July 2017 through September 2017, the Company sold 464,108 shares of its common stock under its “at-the-market” offering program at prices ranging from $5.64 to $10.54. The gross proceeds from the offering were $4.3 million, before deducting underwriting discounts and commissions and other offering expenses. In the fourth quarter of 2017, the Company completed a public offering, pursuant to which it sold 4,630,000 shares of its common stock, Series A warrants to purchase up to 4,630,000 shares of common stock and Series B warrants to purchase up to 4,630,000 shares of common stock at a public offering price of $3.50 per share and accompanying warrants. The gross proceeds from the public offering were approximately $16.2 million, before deducting underwriting discounts and commissions and other offering expenses. As of September 30, 2018, the Company had issued 8,598,076 shares upon exercise of Series A and Series B warrants, which resulted in gross proceeds to the Company of $29.5 million. As of September 30, 2018, there were 516,030 Series A warrants outstanding and no Series B warrants outstanding. In April 2018, 13,450 Series B warrants expired unexercised. In the first quarter of 2018, the Company completed a public offering of 34,500,000 shares of its common stock at a public offering price of $2.00 per share. The gross proceeds to the Company from the offering were $69.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. In August 2018, the Company completed a public offering of 4,035,085 shares of its common stock at a public offering price of $28.50 per share. The gross proceeds to the Company from the offering were $115.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. Shares Reserved for Future Issuance The following shares of the Company’s common stock were reserved for future issuance as of September 30, 2018 (in thousands): Shares underlying outstanding warrants 809 Shares underlying outstanding stock options 5,655 Shares authorized for future equity award grants 1,189 Shares authorized for issuance as ESPP awards 2,101 9,754 In June 2018, the Company received approval from its stockholders t o the 2013 Plan The Company issued 8,598,076 shares of its common stock upon the exercise of warrants, and 31,519 shares of its common stock upon the exercise of stock options during the nine months ended September 30, 2018. The Company did not issue any shares of its common stock upon the exercise of warrants, and issued 24,406 shares of its common stock upon the exercise of stock options during the year ended December 31, 2017. The ESPP enables eligible employees to purchase shares of common stock using their after-tax payroll deductions, subject to certain conditions. Historically, offerings under t he ESPP consisted of a two-year offering period with four six-month purchase periods which began in May and November of each year. In June 2018, the Company received approval from its stockholders to increase the number of shares reserved for issuance under the ESPP by 2,000,000 shares. A new offering commenced under the ESPP on June 15, 2018, and the first purchase date will be November 15, 2018. 38,929 Stock-Based Compensation In June 2018, the Company issued options to purchase 811,800 shares of common stock under the 2013 Plan, which were originally granted on December 1, 2017, subject to and conditioned upon the approval by its stockholders of an increase in the number of shares authorized under the 2013 Plan The assumptions used in the Black-Scholes option-pricing model are as follows: Stock Options Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Weighted average grant date fair value (per share) $ 21.77 $ 3.00 $ 12.35 $ 5.10 Risk-free interest rate 2.8 % 2.0 % 2.8 % 1.9 % Expected dividend yield 0.0 % 0.0 % 0.0 % 0.0 % Expected volatility 70.5 % 60.3 % 71.4 % 60.0 % Expected term (in years) 6.1 6.1 5.7 6.1 ESPP Nine Months Ended September 30, 2018 2017 (1) Weighted average grant date fair value (per share) $ 9.62 N/A Risk-free interest rate 2.4 % N/A Expected dividend yield 0.0 % N/A Expected volatility 77.0 % N/A Expected term (in years) 1.3 N/A (1) There were no grants made pursuant to the ESPP during the nine months ended September 30, 2017. The following table summarizes the allocation of stock-based compensation expense (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Cost of sales $ 784 $ 264 $ 1,129 $ 1,022 Selling, general & administrative 6,821 1,961 9,833 8,423 Research and development 1,932 167 2,465 1,057 Total $ 9,537 $ 2,392 $ 13,427 $ 10,502 The total stock-based compensation expense capitalized as part of the cost of inventory was $0.7 million and $0.2 million as of September 30, 2018 and December 31, 2017, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies From time to time, the Company may be subject to legal proceedings, disputes and other claims arising in the ordinary course of business, including actions with respect to intellectual property, employment, product liability and contractual matters. In connection with these matters, the Company regularly assesses the probability and amount or range of possible loss based on the developments in these matters. A liability is recorded in the financial statements if it is determined that it is probable that a material loss has been incurred, and that the amount or range of the loss can be reasonably estimated. Because of uncertainties related to any pending actions, the Company is currently unable to predict their ultimate outcome, and, with respect to any legal proceeding or claim where no liability has been accrued, to make a meaningful estimate of the reasonably possible loss or range of loss that could result from an adverse outcome. As of September 30, 2018 and December 31, 2017, there were no legal proceedings, disputes or other claims for which a material loss was considered probable or for which the amount or range of loss was reasonably estimable. However, regardless of the outcome, legal proceedings, disputes and other claims can have an adverse impact on the Company because of legal costs, diversion of management time and resources, and other factors. |
Organization and Basis of Pre_2
Organization and Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
The Company | The Company Tandem Diabetes Care, Inc. is a medical device company focused on the design, development and commercialization of products for people with insulin-dependent diabetes. The Company is incorporated in the state of Delaware. Unless the context requires otherwise, the terms the “Company” or “Tandem” refer to Tandem Diabetes Care, Inc. The Company manufactures and sells insulin pump products that are designed to address large and differentiated needs of the insulin-dependent diabetes market. The Company’s manufacturing and sales activities primarily focus on the t:slim X2 Insulin Delivery System (t:slim X2), the next-generation flagship product that is updatable and designed to display continuous glucose monitoring (CGM), sensor information directly on the pump Home Screen. The Company’s insulin pump products are generally considered durable medical equipment, and have an expected lifespan of at least four years. In addition to selling insulin pumps, the Company sells disposable products that are used together with the pumps and are replaced every few days, including cartridges for storing and delivering insulin, and infusion sets that connect the insulin pump to a user’s body. The Company’s insulin pump products are compatible with the Tandem Device Updater, . The Company began commercial sales of its first product, t:slim, in August 2012 and subsequently commercialized t:flex in May 2015, t:slim G4 in September 2015 and t:slim X2 in October 2016. T he t:slim X2 hardware platform now represents 100% of new pump shipments, but t In June 2018, the Company received approval by the United States Food and Drug Administration (FDA) for t:slim X2 with Basal-IQ technology, the Company’s first generation Automated Insulin Delivery (AID) algorithm, and commenced commercial sales of this product in August 2018. In August 2018, the Company commenced sales of the t:slim X2 in select geographies outside the United States. In July 2016, the Company launched a Technology Upgrade Program that provided eligible t:slim and t:slim G4 customers a path to obtain the t:slim X2 hardware platform. Participating customers had the right to exchange their original t:slim and t:slim G4 for a t:slim X2 under a variable pricing structure. The Technology Upgrade Program expired on September 30, 2017. The Company has incurred operating losses since its inception and, as reflected in the accompanying financial statements, the Company had an accumulated deficit of $603.8 million as of September 30, 2018, which included a net loss of $126.3 million for the nine months ended September 30, 2018. Management expects operating losses and negative cash flows to continue for at least the next 12 months. As of September 30, 2018, the Company had $113.6 million in cash and cash equivalents and short-term investments in marketable securities. Management believes that the cash and investments on hand will be sufficient to satisfy its liquidity requirements for at least the next 12 months. The Company’s ability to execute on its business strategy, meet its future liquidity requirements, and achieve and maintain profitable operations, is dependent on a number of factors, including its ability to continue to gain market acceptance of its products and achieve a level of revenues adequate to support its cost structure, achieve renewal pump sales objectives, develop and launch new products, increase gross profits from higher sales of infusion sets, maximize manufacturing efficiencies, satisfy increasing production requirements, leverage the investments made in its sales, clinical, marketing and customer support organizations and operate its business and manufacture and sell products without infringing third party intellectual property rights. The Company has funded its operations primarily through private and public equity and debt financing. The Company may in the future seek additional capital from public |
Basis of Presentation | Basis of Presentation The Company has funded its operations primarily through private and public equity and debt financing. The Company may in the future seek additional capital from public Interim financial results are not necessarily indicative of results anticipated for the full year or any other period(s). These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and accompanying footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 (Annual Report), from which the balance sheet information herein was derived. These unaudited condensed consolidated financial statements exclude disclosures required by U.S. GAAP for complete financial statements. The condensed consolidated financial statements include the accounts of Tandem Diabetes Care, Inc. and its wholly owned subsidiary in Canada. All significant intercompany balances and transactions have been eliminated in consolidation. |
Reclassifications | Reclassifications Certain reclassifications of prior year amounts have been made to conform to the current year presentation. |
Use of Estimates | Use of Estimates The preparation of the financial statements in conformity with U.S. GAAP requires management to make informed estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying footnotes as of the date of the financial statements. Actual results could materially differ from those estimates and assumptions. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which discrete financial information is available for evaluation by the chief operating decision-maker (CODM) in making decisions regarding resource allocation and assessing performance. The Company’s current product offering consists primarily of . s key operating decisions and resource allocations are made by the CODM using consolidated financial data |
Restricted Cash | Restricted Cash The Company recorded $10.0 million of restricted cash as of December 31, 2017, for the minimum cash balance requirement in connection with the Amended and Restated Term Loan Agreement (Term Loan Agreement) with Capital Royalty Partners II, L.P. and its affiliated funds (CRG) (see Note 6, Term Loan Agreement). Due to the full repayment of the term loan in August 2018, no restricted cash balance existed at September 30, 2018. In January 2018, the Company adopted new guidance from the Financial Accounting Standards Board (FASB) |
Accounts Receivable | Accounts Receivable The Company grants credit to various customers in the ordinary course of business. The Company maintains an allowance for doubtful accounts for potential credit losses. Provisions are made based on historical experience, assessment of specific risk, review of outstanding invoices, and various assumptions and estimates that are believed to be reasonable under the circumstances. Uncollectible accounts are written off against the allowance after appropriate collection efforts have been exhausted and when it is deemed that a balance is uncollectible. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, accrued expense, and employee-related liabilities are reasonable estimates of their fair values because of the short-term nature of these assets and liabilities. Short-term investments The estimated fair value of certain of the Company’s common stock warrants is determined using the Black-Scholes pricing model as of September 30, 2018 and December 31, 2017 (see Note 5, “Fair Value Measurements”) . |
Revenue Recognition | Revenue Recognition Revenue is generated primarily from sales of insulin pumps, disposable cartridges and infusion sets to individual customers and third-party distributors that resell the product to insulin-dependent diabetes customers. The Company is paid directly by customers who use the products, distributors and third-party insurance payors. In January 2018, the Company adopted the Revenue from Contracts with Customers Standard which supersedes existing revenue guidance under U.S. GAAP and International Financial Reporting Standards. Pursuant to the Revenue from Contracts with Customers Standard’s core principle, subsequent to January 1, 2018, the Company recognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The Company elected to implement this new standard utilizing the modified retrospective method. Under this approach, the Company applied the new standard to all new contracts initiated on or after the effective date, and, for contracts which had remaining obligations as of the effective date, the Company recorded an adjustment to the opening balance of accumulated deficit. The accounting for the significant majority of the Company’s revenues is not impacted by the new guidance. As a result, on January 1, 2018, the Company recorded a net reduction to accumulated deficit in the amount of $149,000, reflecting the accounting change. Prior to the implementation of this new standard, revenue was recognized when persuasive evidence of an arrangement existed, delivery had occurred and title passed, the price was fixed or determinable, and collectability was reasonably assured. The Company At September 30, 2018 and December 31, 2017, $2.7 million and $2.0 million, respectively, were recorded as deferred revenue for these performance obligations that are satisfied over time. Additionally, the Company offers a 30-day right of return to its customers from the date of shipment of any of its insulin pumps, provided a physician’s confirmation of the medical reason for the return is received. Estimated allowances for sales returns are based on historical returned quantities as compared to pump shipments in those same periods of return. The return rate is then applied to the sales of the current period to establish a reserve at the end of the period. The return rates used in the reserve are adjusted for known or expected changes in the marketplace when appropriate. Under the new guidance, the allowance for product returns is recorded as a reduction of revenue and an increase in deferred revenue in the period in which the related sale is recorded. Historically, the allowance was recorded as a reduction of revenue and accounts receivable. The amount recorded on the Company’s balance sheets for product return allowance was |
Warranty Reserve | Warranty Reserve The Company generally provides a four-year warranty on its insulin pumps to end user customers and may replace any pumps that do not function in accordance with the product specifications. Insulin pumps returned to the Company may be refurbished and redeployed. The Company evaluates the reserve quarterly and makes adjustments when appropriate. Changes to the actual replacement rates or the expected product replacement cost could have a material impact on the Company’s estimated warranty reserve. As of September 30, 2018 and December 31, 2017, the warranty reserve was $7.7 million and $5.6 million, respectively. The following table provides a reconciliation of the change in product warranty liabilities from December 31, 2017 through September 30, 2018 (in thousands): Balance at December 31, 2017 $ 5,640 Provision for warranties issued during the period 5,570 Settlements made during the period (5,741 ) Increases in warranty estimates 2,267 Balance at September 30, 2018 $ 7,736 Current portion $ 4,137 Non-current portion 3,599 Total $ 7,736 |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation cost is measured at the grant date based on the estimated fair value of the award, and the portion that is ultimately expected to vest is recognized as compensation expense over the requisite service period on a straight-line basis. The Company estimates the fair value of stock options issued under the Company’s 2013 Stock Incentive Plan (“2013 Plan”) and shares issued under the Company’s 2013 Employee Stock Purchase Plan (“ESPP”) using a Black-Scholes option-pricing model on the date of grant. The Black-Scholes option-pricing model requires the use of subjective assumptions about a number of key variables, including stock price volatility, expected term, and risk-free interest rate. For awards that vest based on the achievement of service conditions, the Company recognizes expense using the straight-line method less estimated forfeitures based on historical experience. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share Potentially dilutive securities not included in the calculation of diluted net loss per share (because inclusion would be anti-dilutive) are as follows (in thousands, in common stock equivalent shares): Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Warrants for common stock 710 - 710 - Common stock options 5,155 8 3,031 3 ESPP 61 - 24 - 5,926 8 3,765 3 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the FASB issued final guidance for lease accounting. The new accounting standard requires lessees to recognize right-of-use assets and corresponding lease liabilities for all leases with lease terms of greater than twelve months. It also changes the definition of a lease and expands the disclosure requirements of lease arrangements. In July 2018, the FASB added a transition option for implementation that allows companies to continue to use the legacy guidance in ASC 840, Leases, including its disclosure requirements, in the comparative periods presented in the year of adoption of the new leases standard. The new accounting standard must be adopted using the modified retrospective approach and will be effective for the Company starting in the first quarter of fiscal 2019. Companies that elect the transition option will record a cumulative-effect adjustment to retained earnings in the period of adoption rather than the earliest period presented. expects that the adoption of this standard will result in a material increase in assets and liabilities on its consolidated balance sheets and In June 2016, the FASB issued an accounting standards update that changes the measurement and recognition of credit losses for most financial assets and certain other instruments. The new standard requires the use of forward-looking expected credit loss models based on historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount, which may result in earlier recognition of credit losses under the new standard. The standard is effective for public business entities for annual periods beginning after December 15, 2019, and interim periods within those years. The Company plans to implement the new standard in the first quarter of fiscal 2020, and is in the process of reviewing its credit loss models to assess the impact of the adoption of the standard on its financial statements. In March 2018, the FASB issued Accounting Standards Update No. 2018-05, Income taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 Income Tax Accounting Implications of the Tax Cuts and Jobs Act. The Company recognized the income tax effects of the 2017 Tax Act in its 2017 financial statements for which the accounting under ASC Topic 740 is incomplete, but a reasonable estimate could be determined. The tax effects of certain provisions of the 2017 Tax Act, such as the deductibility of compensation in excess of $1 million for certain employees, and limitations on executive compensation, requires further analysis. The Company is in the process of assessing the impact of the adoption of the standard on its financial statements. In August 2018, the FASB issued ASU 2018-15 that changes the accounting for implementation costs incurred in a cloud computing arrangement that is a service contract. ASU 2018-15 aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The implementation costs should be presented as a prepaid asset in the balance sheet and expensed over the term of the hosting arrangement. The standard is effective for annual periods, including interim periods within those annual periods, beginning after December 15, 2019. Early adoption is permitted. The Company is in the process of assessing the impact of the adoption of the standard on its financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Summary of Reconciliation of Change in Product Warranty Liabilities | The following table provides a reconciliation of the change in product warranty liabilities from December 31, 2017 through September 30, 2018 (in thousands): Balance at December 31, 2017 $ 5,640 Provision for warranties issued during the period 5,570 Settlements made during the period (5,741 ) Increases in warranty estimates 2,267 Balance at September 30, 2018 $ 7,736 Current portion $ 4,137 Non-current portion 3,599 Total $ 7,736 |
Schedule of Anti-Dilutive Securities | Potentially dilutive securities not included in the calculation of diluted net loss per share (because inclusion would be anti-dilutive) are as follows (in thousands, in common stock equivalent shares): Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Warrants for common stock 710 - 710 - Common stock options 5,155 8 3,031 3 ESPP 61 - 24 - 5,926 8 3,765 3 |
Short-Term Investments (Tables)
Short-Term Investments (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Estimated Fair Value of Short-Term Investments | The Company invests in investment securities, principally debt instruments of financial institutions and corporations with strong credit ratings. The following represents a summary of the estimated fair value of short-term investments as of September 30, 2018 and December 31, 2017 (in thousands): At September 30, 2018 Maturity (in years) Amortized Cost Unrealized Gain Unrealized Loss Estimated Fair Value Available-for-sale investment securities: Commercial paper Less than 1 $ 65,654 $ 1 $ (14 ) $ 65,641 U.S. Treasury securities Less than 1 15,613 — — 15,613 Total $ 81,267 $ 1 $ (14 ) $ 81,254 At December 31, 2017 Maturity (in years) Amortized Cost Unrealized Gain Unrealized Loss Estimated Fair Value Trading securities: Mutual funds held for nonqualified deferred compensation plan participants $ 459 $ 20 $ — $ 479 Total $ 459 $ 20 $ — $ 479 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Inventory Disclosure [Abstract] | |
Summary of Inventory | Inventory consisted of the following as of September 30, 2018 and December 31, 2017 (in thousands): September 30, December 31, 2018 2017 Raw materials $ 8,609 $ 10,328 Work-in-process 4,489 3,812 Finished goods 11,268 12,853 Total $ 24,366 $ 26,993 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2018 and December 31, 2017, and indicates the fair value hierarchy of the valuation techniques utilized by the Company to determine such fair value (in thousands): Fair Value Measurements at September 30, 2018 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (1) $ 28,104 $ 28,104 $ — $ — Commercial paper 65,641 — 65,641 — U.S. Treasury securities 15,613 15,613 — — Total assets $ 109,358 $ 43,717 $ 65,641 $ — Liabilities Common stock warrants $ 20,643 $ — $ — $ 20,643 Total liabilities $ 20,643 $ — $ — $ 20,643 Fair Value Measurements at December 31, 2017 (Level 1) (Level 2) (Level 3) Assets Cash equivalents (1) $ 23,700 $ 23,700 $ — $ — Mutual funds held for nonqualified deferred compensation plan participants (2) 479 479 — — Total assets $ 24,179 $ 24,179 $ — $ — Liabilities Common stock warrants $ 5,432 $ — $ — $ 5,432 Deferred compensation (2) 479 479 — - Total liabilities $ 5,911 $ 479 $ — $ 5,432 (1) Generally, cash equivalents include money market funds and investments with a maturity of three months or less from the date of purchase. This asset is included as a component of cash and cash equivalents on the balance sheet, of which $10.0 million was classified as restricted cash – long-term as of December 31, 2017. (2) The deferred compensation plan was directed by the Company and structured as a Rabbi Trust for the benefit of certain executives and non-employee directors. The investment assets of the Rabbi Trust were valued using quoted market prices multiplied by the number of shares held in each trust account. The related deferred compensation liability represents the fair value of the investment assets . The Company cancelled the deferred compensation plan in 2017 and all deferred compensation amounts were distributed to participants during the second quarter of 2018. |
Schedule of Assumptions Used to Estimate Fair Values of Common Stock Warrants | The assumptions used to estimate the fair values of the common stock warrants at September 30, 2018 and December 31, 2017 are presented below: Series A Warrants September 30, 2018 December 31, 2017 Risk-free interest rate 2.9 % 2.2 % Expected dividend yield 0.0 % 0.0 % Expected volatility 77.6 % 63.5 % Expected term (in years) 4.1 4.8 Series B Warrants September 30, 2018 (1) December 31, 2017 Risk-free interest rate N/A 1.4 % Expected dividend yield N/A 0.0 % Expected volatility N/A 80.3 % Expected term (in years) N/A 0.3 (1) As of September 30, 2018, there were no Series B warrants outstanding. |
Summary of Changes in Fair Value of Total Level 3 Financial Assets | The following table presents a summary of changes in the fair value of the Company’s Level 3 financial assets for the nine months ended September 30, 2018: Balance at December 31, 2017 $ 5,432 Increase in fair value included in change in fair value of common stock warrants 69,042 Decrease in fair value from warrants exercised during the period (53,831 ) Balance at September 30, 2018 $ 20,643 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Equity [Abstract] | |
Schedule of Shares of Common Stock Reserved for Future Issuance | The following shares of the Company’s common stock were reserved for future issuance as of September 30, 2018 (in thousands): Shares underlying outstanding warrants 809 Shares underlying outstanding stock options 5,655 Shares authorized for future equity award grants 1,189 Shares authorized for issuance as ESPP awards 2,101 9,754 |
Schedule of Assumptions Used in Black-Scholes Option-Pricing Model | The assumptions used in the Black-Scholes option-pricing model are as follows: Stock Options Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Weighted average grant date fair value (per share) $ 21.77 $ 3.00 $ 12.35 $ 5.10 Risk-free interest rate 2.8 % 2.0 % 2.8 % 1.9 % Expected dividend yield 0.0 % 0.0 % 0.0 % 0.0 % Expected volatility 70.5 % 60.3 % 71.4 % 60.0 % Expected term (in years) 6.1 6.1 5.7 6.1 ESPP Nine Months Ended September 30, 2018 2017 (1) Weighted average grant date fair value (per share) $ 9.62 N/A Risk-free interest rate 2.4 % N/A Expected dividend yield 0.0 % N/A Expected volatility 77.0 % N/A Expected term (in years) 1.3 N/A (1) There were no grants made pursuant to the ESPP during the nine months ended September 30, 2017. |
Summary for Allocation of Stock-Based Compensation Expense | The following table summarizes the allocation of stock-based compensation expense (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Cost of sales $ 784 $ 264 $ 1,129 $ 1,022 Selling, general & administrative 6,821 1,961 9,833 8,423 Research and development 1,932 167 2,465 1,057 Total $ 9,537 $ 2,392 $ 13,427 $ 10,502 |
Organization and Basis of Pre_3
Organization and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Organization And Basis Of Presentation [Line Items] | |||||
Operating losses and accumulated deficit | $ (603,763) | $ (603,763) | $ (477,613) | ||
Net loss | (34,245) | $ (16,035) | (126,299) | $ (61,627) | |
Cash and cash equivalents and short-term investments in marketable securities | $ 113,600 | $ 113,600 | |||
Insulin Pump [Member] | Minimum [Member] | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Expected life span term | 4 years | ||||
T:slim X2 [Member] | |||||
Organization And Basis Of Presentation [Line Items] | |||||
Percentage of new pump shipments represented by product hardware platform | 100.00% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 9 Months Ended | ||
Sep. 30, 2018USD ($)Segment | Jan. 01, 2018USD ($) | Dec. 31, 2017USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Number of operating segments | Segment | 1 | ||
Offered period for sales return | 30 days | ||
Allowance for product returns | $ 200,000 | $ 200,000 | |
Warranty reserve | $ 7,736,000 | 5,640,000 | |
Description on incomplete accounting under TCJA | The Company recognized the income tax effects of the 2017 Tax Act in its 2017 financial statements for which the accounting under ASC Topic 740 is incomplete, but a reasonable estimate could be determined. The tax effects of certain provisions of the 2017 Tax Act, such as the deductibility of compensation in excess of $1 million for certain employees, and limitations on executive compensation, requires further analysis. | ||
Warranty reserves [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Warranty reserve | $ 7,700,000 | 5,600,000 | |
Complementary products [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Deferred revenue | $ 2,700,000 | 2,000,000 | |
Revenue performance obligations satisfied over period | 4 years | ||
Tandem Pump [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Warranty period offered | 4 years | ||
Slim cartridges and infusion sets [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Warranty period offered | 6 months | ||
ASU 2014-09: Revenue from Contracts with Customers [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Net reduction to accumulated deficit | $ 149,000 | ||
Term Loan Agreement [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Restricted cash | $ 0 | $ 10,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Summary of Reconciliation of Change in Product Warranty Liabilities (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Movement In Standard And Extended Product Warranty Increase Decrease Roll Forward | |
Beginning balance | $ 5,640 |
Provision for warranties issued during the period | 5,570 |
Settlements made during the period | (5,741) |
Increases in warranty estimates | 2,267 |
Ending balance | 7,736 |
Current portion | 4,137 |
Non-current portion | $ 3,599 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Anti-Dilutive Securities (Detail) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share, amount | 5,926 | 8 | 3,765 | 3 |
Warrants for common stock [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share, amount | 710 | 710 | ||
Common stock options [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share, amount | 5,155 | 8 | 3,031 | 3 |
ESPP [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share, amount | 61 | 24 |
Short-Term Investments - Summar
Short-Term Investments - Summary of Estimated Fair Value of Short-Term Investments (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Dec. 31, 2017 | |
Cash Cash Equivalents And Short Term Investments [Line Items] | ||
Short-term investments, Amortized Cost | $ 81,267 | $ 459 |
Short-term investments, Unrealized Gain | 1 | 20 |
Short-term investments, Unrealized Loss | (14) | |
Short-term investments, Estimated Fair Value | 81,254 | 479 |
Commercial paper [Member] | ||
Cash Cash Equivalents And Short Term Investments [Line Items] | ||
Available-for-sale investment securities, Amortized Cost | 65,654 | |
Available-for-sale investment securities, Unrealized Gain | 1 | |
Available-for-sale investment securities, Unrealized Loss | (14) | |
Available-for-sale investment securities, Estimated Fair Value | $ 65,641 | |
Commercial paper [Member] | Maximum [Member] | ||
Cash Cash Equivalents And Short Term Investments [Line Items] | ||
Available-for-sale investment securities, Maturity (in years) | 1 year | |
U.S. Treasury securities [Member] | ||
Cash Cash Equivalents And Short Term Investments [Line Items] | ||
Available-for-sale investment securities, Amortized Cost | $ 15,613 | |
Available-for-sale investment securities, Estimated Fair Value | $ 15,613 | |
U.S. Treasury securities [Member] | Maximum [Member] | ||
Cash Cash Equivalents And Short Term Investments [Line Items] | ||
Available-for-sale investment securities, Maturity (in years) | 1 year | |
Trading securities — mutual funds held for nonqualified deferred compensation plan participants [Member] | ||
Cash Cash Equivalents And Short Term Investments [Line Items] | ||
Trading securities, Amortized Cost | 459 | |
Trading securities, Unrealized Gain | 20 | |
Trading securities, Estimated Fair Value | $ 479 |
Inventory - Summary of Inventor
Inventory - Summary of Inventory (Detail) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 8,609 | $ 10,328 |
Work-in-process | 4,489 | 3,812 |
Finished goods | 11,268 | 12,853 |
Total | $ 24,366 | $ 26,993 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total assets | $ 109,358 | $ 24,179 |
Total liabilities | 20,643 | 5,911 |
Cash equivalents [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total assets | 28,104 | 23,700 |
Commercial paper [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total assets | 65,641 | |
U.S. Treasury securities [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total assets | 15,613 | |
Mutual funds held for nonqualified deferred compensation plan participants [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total assets | 479 | |
Warrants for common stock [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total liabilities | 20,643 | 5,432 |
Deferred compensation [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total liabilities | 479 | |
Level 1 [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total assets | 43,717 | 24,179 |
Total liabilities | 479 | |
Level 1 [Member] | Cash equivalents [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total assets | 28,104 | 23,700 |
Level 1 [Member] | U.S. Treasury securities [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total assets | 15,613 | |
Level 1 [Member] | Mutual funds held for nonqualified deferred compensation plan participants [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total assets | 479 | |
Level 1 [Member] | Deferred compensation [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total liabilities | 479 | |
Level 2 [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total assets | 65,641 | |
Level 2 [Member] | Commercial paper [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total assets | 65,641 | |
Level 3 [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total liabilities | 20,643 | 5,432 |
Level 3 [Member] | Warrants for common stock [Member] | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Total liabilities | $ 20,643 | $ 5,432 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Parenthetical) (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |
Restricted cash—long term | $ 10,000 |
Maximum [Member] | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |
Cash equivalents maturity term | 3 months |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 1 Months Ended | 9 Months Ended | 12 Months Ended |
Apr. 30, 2018 | Sep. 30, 2018 | Dec. 31, 2017 | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |||
Transfer between level 1 and level 2 assets | $ 0 | ||
Series A warrants [Member] | |||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |||
Outstanding warrants | 516,030 | ||
Series A warrants [Member] | Secondary Public Offering [Member] | |||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |||
Warrants issue to purchase common stock | 4,630,000 | 4,630,000 | |
Public offering period | 5 years | 5 years | |
Warrants exercise price | $ 3.50 | $ 3.50 | |
Series B warrants [Member] | |||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |||
Outstanding warrants | 0 | ||
Warrants to purchase common stock, expired unexercised | 13,450,000 | 13,450 | |
Series B warrants [Member] | Secondary Public Offering [Member] | |||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |||
Warrants issue to purchase common stock | 0 | 4,630,000 | |
Public offering period | 6 months | ||
Warrants exercise price | $ 3.50 | ||
Series A and B warrants [Member] | |||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | |||
Warrants issue to purchase common stock | 8,598,076 | ||
Warrants initial value | $ 6,500,000 |
Fair Value Measurements - Sch_3
Fair Value Measurements - Schedule of Assumptions Used to Estimate Fair Values of Common Stock Warrants (Detail) | Sep. 30, 2018 | Dec. 31, 2017 |
Series A Warrants [Member] | Risk Free Interest Rate [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Assumptions used to estimate fair value of common stock warrants | 2.9 | 2.2 |
Series A Warrants [Member] | Expected Dividend Yield [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Assumptions used to estimate fair value of common stock warrants | 0 | 0 |
Series A Warrants [Member] | Expected Volatility [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Assumptions used to estimate fair value of common stock warrants | 77.6 | 63.5 |
Series A Warrants [Member] | Expected Term [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Expected term (in years) | 4 years 1 month 6 days | 4 years 9 months 18 days |
Series B Warrants [Member] | Risk Free Interest Rate [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Assumptions used to estimate fair value of common stock warrants | 1.4 | |
Series B Warrants [Member] | Expected Dividend Yield [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Assumptions used to estimate fair value of common stock warrants | 0 | |
Series B Warrants [Member] | Expected Volatility [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Assumptions used to estimate fair value of common stock warrants | 80.3 | |
Series B Warrants [Member] | Expected Term [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Expected term (in years) | 3 months 18 days |
Fair Value Measurements - Sch_4
Fair Value Measurements - Schedule of Assumptions Used to Estimate Fair Values of Common Stock Warrants (Parenthetical) (Detail) | Sep. 30, 2018shares |
Series B warrants [Member] | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | |
Outstanding warrants | 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Changes in Fair Value of Total Level 3 Financial Assets (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation Calculation Roll Forward | |
Balance at December 31, 2017 | $ 5,432 |
Increase in fair value included in change in fair value of common stock warrants | 69,042 |
Decrease in fair value from warrants exercised during the period | (53,831) |
Balance at September 30, 2018 | $ 20,643 |
Term Loan Agreement - Additiona
Term Loan Agreement - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 27 Months Ended | |||||
Feb. 28, 2018 | Dec. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Aug. 31, 2018 | Oct. 01, 2015 | Sep. 30, 2015 | |
Debt Instrument [Line Items] | |||||||||
Accrued interest | $ 2,832,000 | $ 3,931,000 | $ 3,931,000 | $ 2,832,000 | |||||
Debt discount associated with financing fees and debt issuance costs | 1,721,000 | $ 1,338,000 | |||||||
Loss on extinguishment of debt | 5,313,000 | 5,313,000 | |||||||
Compounded interest payable | 2.00% | ||||||||
Additional amount borrowed | $ 1,236,000 | 2,700,000 | |||||||
Term Loan Agreement [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Loan outstanding | 82,700,000 | 0 | $ 0 | 82,700,000 | $ 82,700,000 | ||||
Accrued interest | 1,100,000 | ||||||||
Associated financing fees | $ 5,000,000 | ||||||||
Debt discount associated with financing fees and debt issuance costs | 6,200,000 | ||||||||
Loss on extinguishment of debt | $ 5,300,000 | ||||||||
Interest rate | 11.50% | 11.50% | 11.50% | ||||||
Interest payable as cash | 9.50% | 9.50% | 9.50% | ||||||
Compounded interest payable | 2.00% | 2.00% | |||||||
Interest-only payments description | Under the Term Loan Agreement, interest was payable at the Company’s option, (i) in cash at a rate of 11.5% per annum, or (ii) at a rate of 9.5% of the 11.5% per annum in cash and 2.0% of the 11.5% per annum (the “PIK Loan”) to be added to the principal of the loan and subject to accruing interest. Interest-only payments were due quarterly on March 31, June 30, September 30 and December 31 of each year of the interest-only payment period, which would have ended on December 31, 2019. | ||||||||
Maturity date for interest-only payment | Dec. 31, 2019 | ||||||||
Maturity date for principal balance | Mar. 31, 2020 | ||||||||
Term Loan Amendments [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Warrants life | 10 years | ||||||||
Warrants issue to purchase common stock | 193,788 | 193,788 | |||||||
Warrants exercise price | $ 23.50 | $ 23.50 | |||||||
Present value of the future cash flows | 10.00% | 10.00% | |||||||
Accrued back end financing fee | $ 5,000,000 | $ 4,100,000 | $ 4,100,000 | ||||||
Term Loan Amendments [Member] | Other Long Term Liabilities And As Contra-Debt In Notes Payable-Long Term [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Prepayment fee percentage | 6.00% | 5.00% |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Dec. 01, 2017 | Aug. 31, 2018 | Jun. 30, 2018 | Apr. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Gross proceeds from secondary public offering | $ 115,000 | $ 69,000 | $ 16,200 | $ 23,100 | |||||||
Gross proceeds from exercise of warrants | $ 29,536 | ||||||||||
Shares vested | 50.00% | ||||||||||
Total stock-based compensation expense capitalized as part of cost of inventory | $ 700 | $ 200 | |||||||||
Common stock options [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Common stock shares issued | 31,519 | 24,406 | |||||||||
2013 Plan [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Number of shares of authorized for issuance | 5,500,000 | ||||||||||
Series A warrants [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Outstanding warrants | 516,030 | ||||||||||
Series B warrants [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Outstanding warrants | 0 | ||||||||||
Warrants to purchase common stock, expired unexercised | 13,450,000 | 13,450 | |||||||||
Series A and B warrants [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Warrants issue to purchase common stock | 8,598,076 | ||||||||||
Gross proceeds from exercise of warrants | $ 29,500 | ||||||||||
Common Stock [Member] | 2013 Plan [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Shares granted | 811,800 | 3,339,300 | |||||||||
Warrants for common stock [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Common stock shares issued | 8,598,076 | 0 | |||||||||
Secondary Public Offering [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Shares offered for public offering | 4,035,085 | 34,500,000 | 4,630,000 | 1,850,000 | |||||||
Shares offering price per share | $ 28.50 | $ 2 | $ 3.50 | $ 12.50 | $ 3.50 | ||||||
Secondary Public Offering [Member] | Series A warrants [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Warrants issue to purchase common stock | 4,630,000 | 4,630,000 | 4,630,000 | ||||||||
Secondary Public Offering [Member] | Series B warrants [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Warrants issue to purchase common stock | 4,630,000 | 0 | 4,630,000 | ||||||||
At The Market Offering Program [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Proceeds from secondary public offering | $ 4,300 | ||||||||||
At The Market Offering Program [Member] | Common Stock [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Shares offered for public offering | 464,108 | ||||||||||
At The Market Offering Program [Member] | Common Stock [Member] | Minimum [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Shares offering price per share | $ 5.64 | $ 5.64 | |||||||||
At The Market Offering Program [Member] | Common Stock [Member] | Maximum [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Shares offering price per share | $ 10.54 | $ 10.54 | |||||||||
ESPP [Member] | |||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||||
Purchase of common stock under ESPP | 0 | 38,929 | |||||||||
Offering Period | 2 years | ||||||||||
Purchase Period | four six-month | ||||||||||
Shares reserved for issuance under the ESPP | 2,000,000 | ||||||||||
Shares granted | 0 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Shares of Common Stock Reserved for Future Issuance (Detail) shares in Thousands | Sep. 30, 2018shares |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Common stock reserved for future issuance | 9,754 |
Shares underlying outstanding warrants [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Common stock reserved for future issuance | 809 |
Shares underlying outstanding stock options [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Common stock reserved for future issuance | 5,655 |
Shares authorized for future equity award grants [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Common stock reserved for future issuance | 1,189 |
Shares authorized for issuance as ESPP awards [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Common stock reserved for future issuance | 2,101 |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Assumptions Used in Black-Scholes Option-Pricing Model (Detail) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Employee Stock Option [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Weighted average grant date fair value (per share) | $ 21.77 | $ 3 | $ 12.35 | $ 5.10 |
Risk-free interest rate | 2.80% | 2.00% | 2.80% | 1.90% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Expected volatility | 70.50% | 60.30% | 71.40% | 60.00% |
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 5 years 8 months 12 days | 6 years 1 month 6 days |
ESPP [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Weighted average grant date fair value (per share) | $ 9.62 | |||
Risk-free interest rate | 2.40% | |||
Expected dividend yield | 0.00% | |||
Expected volatility | 77.00% | |||
Expected term (in years) | 1 year 3 months 18 days |
Stockholders' Equity - Schedu_3
Stockholders' Equity - Schedule of Assumptions Used in Black-Scholes Option-Pricing Model (Parenthetical) (Detail) | 9 Months Ended |
Sep. 30, 2017shares | |
ESPP [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Grants made during period | 0 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary for Allocation of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Compensation cost | $ 9,537 | $ 2,392 | $ 13,427 | $ 10,502 |
Cost of sales [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Compensation cost | 784 | 264 | 1,129 | 1,022 |
Selling, general & administrative [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Compensation cost | 6,821 | 1,961 | 9,833 | 8,423 |
Research and development [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Compensation cost | $ 1,932 | $ 167 | $ 2,465 | $ 1,057 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - LegalMatter | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | ||
Number of legal proceedings, regulatory encounters or other matters | 0 | 0 |