Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2018 | Jul. 31, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | XENT | |
Entity Registrant Name | INTERSECT ENT, INC. | |
Entity Central Index Key | 1,271,214 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 30,454,533 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 11,803 | $ 19,837 | |
Short-term investments, available-for-sale | 93,094 | 82,483 | |
Accounts receivable, net | 14,640 | 16,589 | |
Inventory | 9,133 | 8,474 | |
Prepaid expenses and other current assets | 1,893 | 2,908 | |
Total current assets | 130,563 | 130,291 | |
Property and equipment, net | 4,656 | 4,848 | |
Other non-current assets | 369 | 436 | |
Total assets | 135,588 | 135,575 | |
Current liabilities: | |||
Accounts payable | 2,967 | 3,400 | |
Accrued compensation | 8,698 | 13,152 | |
Other current liabilities | 1,073 | 1,125 | |
Total current liabilities | 12,738 | 17,677 | |
Deferred rent and other non-current liabilities | 471 | 679 | |
Total liabilities | 13,209 | 18,356 | |
Commitments and contingencies (note 8) | |||
Stockholders' equity: | |||
Preferred stock, $0.001 par value; Authorized shares: 10,000 at June 30, 2018 and December 31, 2017; Issued and outstanding shares: none | |||
Common stock, $0.001 par value; Authorized shares: 150,000 at June 30, 2018 and December 31, 2017; Issued and outstanding shares: 30,435 at June 30, 2018 and 29,678 at December 31, 2017 | 30 | 30 | |
Additional paid-in capital | 297,572 | 282,121 | |
Accumulated other comprehensive loss | (87) | (92) | |
Accumulated deficit | (175,136) | (164,840) | |
Total stockholders' equity | 122,379 | 117,219 | |
Total liabilities and stockholders' equity | $ 135,588 | $ 135,575 | |
[1] | Amounts have been derived from the December 31, 2017 audited financial statements included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission. |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2018 | Dec. 31, 2017 | [1] |
Statement of Financial Position [Abstract] | |||
Preferred stock, par value | $ 0.001 | $ 0.001 | |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |
Preferred stock, shares issued | 0 | 0 | |
Preferred stock, shares outstanding | 0 | 0 | |
Common stock, par value | $ 0.001 | $ 0.001 | |
Common stock, shares authorized | 150,000,000 | 150,000,000 | |
Common stock, shares issued | 30,435,000 | 29,678,000 | |
Common stock, shares outstanding | 30,435,000 | 29,678,000 | |
[1] | Amounts have been derived from the December 31, 2017 audited financial statements included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission. |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Income Statement [Abstract] | ||||
Revenue | $ 26,300 | $ 23,985 | $ 51,023 | $ 44,459 |
Cost of sales | 5,558 | 3,684 | 11,040 | 6,568 |
Gross profit | 20,742 | 20,301 | 39,983 | 37,891 |
Operating expenses: | ||||
Selling, general and administrative | 21,005 | 18,682 | 42,521 | 39,001 |
Research and development | 4,374 | 4,176 | 8,647 | 8,396 |
Total operating expenses | 25,379 | 22,858 | 51,168 | 47,397 |
Loss from operations | (4,637) | (2,557) | (11,185) | (9,506) |
Interest income and other, net | 477 | 288 | 889 | 556 |
Net loss | (4,160) | (2,269) | (10,296) | (8,950) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on short-term investments | 70 | (8) | 5 | (3) |
Comprehensive loss | $ (4,090) | $ (2,277) | $ (10,291) | $ (8,953) |
Net loss per share, basic and diluted | $ (0.14) | $ (0.08) | $ (0.34) | $ (0.31) |
Weighted average common shares used to compute net loss per share, basic and diluted | 30,264 | 28,950 | 30,072 | 28,830 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | ||
Operating activities: | |||
Net loss | $ (10,296) | $ (8,950) | |
Adjustments to reconcile net loss to cash used in operating activities: | |||
Depreciation and amortization | 837 | 689 | |
Stock-based compensation expense | 6,743 | 4,772 | |
Amortization of net investment discount | (254) | (15) | |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | 1,949 | 2,168 | |
Inventory | (659) | (2,366) | |
Prepaid expenses and other assets | 375 | (90) | |
Accounts payable | (470) | (645) | |
Accrued compensation | (4,454) | (1,204) | |
Deferred rent and other liabilities | (260) | (196) | |
Net cash used in operating activities | (6,489) | (5,837) | |
Investing activities: | |||
Purchases of short-term investments | (68,583) | (61,592) | |
Maturities of short-term investments | 58,232 | 69,680 | |
Purchases of property and equipment | (549) | (981) | |
Net cash (used in) provided by investing activities | (10,900) | 7,107 | |
Financing activities: | |||
Proceeds from issuance of common stock | 9,355 | 2,894 | |
Net cash provided by financing activities | 9,355 | 2,894 | |
Net (decrease) increase in cash and cash equivalents | (8,034) | 4,164 | |
Cash and cash equivalents: | |||
Beginning of the period | 19,837 | [1] | 9,859 |
End of the period | 11,803 | 14,023 | |
Non-cash investing activities: | |||
Property and equipment included in accounts payable | $ 183 | $ 121 | |
[1] | Amounts have been derived from the December 31, 2017 audited financial statements included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission. |
Organization
Organization | 6 Months Ended |
Jun. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization Description of Business Intersect ENT, Inc. (the “Company”) is incorporated in the state of Delaware and its facilities are located in Menlo Park, California. The Company is a commercial drug delivery company committed to improving the quality of life for patients with ear, nose and throat conditions. The Company’s approved products are steroid releasing implants designed to treat the spectrum of needs among patients who are managed by ear, nose and throat (“ENT”) physicians for chronic sinusitis. The Company’s current commercial products comprise the PROPEL ® ® ® ® ® |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Preparation The financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”). These financial statements include the accounts of the Company and its consolidated subsidiary. All intercompany balances and transactions have been eliminated in consolidation. The functional currency of Intersect ENT GmbH, which the Company established in June 2018, is the U.S. dollar. Transaction gains and losses are included in interest income and other, net, on the Company’s statements of operations. The interim financial data as of June 30, 2018, is unaudited and is not necessarily indicative of the results for the full year. In the opinion of the Company’s management, the interim data includes only normal and recurring adjustments necessary for a fair presentation of the Company’s financial results for the three and six months ended June 30, 2018 and 2017. Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to SEC rules and regulations relating to interim financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements. Management uses significant judgment when making estimates related to its revenue related allowances, common stock valuation and related stock-based compensation, as well as certain accrued liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. Significant Accounting Policies There have been no significant changes to the accounting policies during the six months ended June 30, 2018, as compared to the significant accounting policies described in Note 2 of the “Notes to Financial Statements” in the Company’s audited financial statements included in its Annual Report, except as described below. Revenue Recognition The Company adopted Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, The PROPEL family of products are regulated by the FDA as medical devices. The Company recognizes revenue through sales of its PROPEL family of products to hospitals and ambulatory surgery centers located almost entirely in the United States when control of the product is transferred to the customer, typically upon shipment of goods to the customer, satisfying the Company’s only performance obligation. The FDA has approved SINUVA as a pharmaceutical product and it is therefore regulated as such. The Company sells SINUVA to a limited number of specialty pharmacies and specialty distributors in the United States, (“Resellers”). These Resellers subsequently sell SINUVA to health care providers. Revenue from SINUVA sales are recognized when control of the product is transferred to the Resellers, typically upon receipt of goods by the Reseller, satisfying the Company’s only performance obligation. The Company recognizes product sales discounts, rebates, returns and other allowances as a reduction of revenue in the same period the related revenue is recognized. In addition to the agreements with the Resellers, the Company enters into arrangements with governmental agencies that result in rebates, chargebacks and discounts with respect to the purchase of SINUVA. These amounts include prompt pay discounts, Medicaid rebates, chargebacks related to Federal Supply Schedule of the General Services Administration and 340B of the Public Health Service Act as well as other allowances that may be offered within contracts between the Company and its direct or indirect customers relating to the Company’s sales of SINUVA, collectively referred to as “Discounts and Rebates.” Discounts and Rebates are based on amounts owed or expected to be owed on the related sales. These estimates take into consideration the Company’s historical experience, the shelf life of the product, current contractual and statutory requirements, specific known market events and trends and industry data. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect revenue and earnings in the period such variances become known. In the balance sheet, such amounts are generally classified as reductions of accounts receivable if the amount is payable to the Resellers, or a current liability if the amount is payable to a party other than the Reseller. Recent Accounting Pronouncements There have been no significant changes to the disclosures in the recent accounting pronouncements during the six months ended June 30, 2018, as compared to the recent accounting pronouncements described in Note 2 of the “Notes to Financial Statements” in the Company’s audited financial statements included in its Annual Report. |
Composition of Certain Financia
Composition of Certain Financial Statement Items | 6 Months Ended |
Jun. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Composition of Certain Financial Statement Items | 3. Composition of Certain Financial Statement Items Accounts Receivable (in thousands): June 30, December 31, Accounts receivable $ 14,748 $ 16,739 Allowance for doubtful accounts (108 ) (150 ) $ 14,640 $ 16,589 Inventory (in thousands): June 30, December 31, Raw materials $ 1,515 $ 1,221 Work-in-process 279 302 Finished goods 7,339 6,951 $ 9,133 $ 8,474 |
Cash, Cash Equivalents and Shor
Cash, Cash Equivalents and Short-term Investments | 6 Months Ended |
Jun. 30, 2018 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Short-term Investments | 4. Cash, Cash Equivalents and Short-term Investments The following is a summary of cash, cash equivalents and short-term investments, available-for-sale, June 30, 2018 December 31, 2017 Amortized Gross Unrealized Estimated Amortized Gross Unrealized Estimated Cost Gains Losses Fair Value Cost Gains Losses Fair Value Cash $ 9,379 $ — $ — $ 9,379 $ 7,646 $ — $ — $ 7,646 Money market funds 2,424 — — 2,424 12,191 — — 12,191 Corporate debt securities 46,605 — (79 ) 46,526 61,695 1 (69 ) 61,627 Commercial paper 46,576 4 (12 ) 46,568 20,880 — (24 ) 20,856 $ 104,984 $ 4 $ (91 ) $ 104,897 $ 102,412 $ 1 $ (93 ) $ 102,320 Reported as: Cash and cash equivalents $ 11,803 $ 19,837 Short-term investments, available-for-sale 93,094 82,483 $ 104,897 $ 102,320 As of June 30, 2018 and December 31, 2017, the Company had no investments with a contractual maturity of greater than one year. Based on an evaluation of securities that have been in a loss position, the Company did not recognize any other-than-temporary impairment charges during the six months ended June 30, 2018 and year ended December 31, 2017. The Company considered various factors which included a credit and liquidity assessment of the underlying securities and the Company’s intent and ability to hold the underlying securities until the estimated date of recovery of its amortized cost. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 5. Fair Value of Financial Instruments The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents and short-term investments, available-for-sale. Level 1 – Observable inputs such as quoted prices (unadjusted) for identical assets or liabilities in active markets. Level 2 – Other inputs that are based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be derived from observable market data. Level 3 – Unobservable inputs that are supported by little or no market activities, which would require the Company to develop its own assumptions. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Cash, Cash Equivalents and Short-term Investments The following is a summary of cash, cash equivalents and short-term investments, available-for-sale, June 30, 2018 December 31, 2017 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Cash $ 9,379 $ — $ — $ 9,379 $ 7,646 $ — $ — $ 7,646 Money market funds 2,424 — — 2,424 12,191 — — 12,191 Corporate debt securities — 46,526 — 46,526 — 61,627 — 61,627 Commercial paper — 46,568 — 46,568 — 20,856 — 20,856 $ 11,803 $ 93,094 $ — $ 104,897 $ 19,837 $ 82,483 $ — $ 102,320 Reported as: Cash and cash equivalents $ 11,803 $ 19,837 Short-term investments, available-for-sale 93,094 82,483 $ 104,897 $ 102,320 There were no transfers in and out of Level 1 and Level 2 during the six months ended June 30, 2018 and year ended December 31, 2017. |
Stock-based Compensation Expens
Stock-based Compensation Expense | 6 Months Ended |
Jun. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based Compensation Expense | 6. Stock-based Compensation Expense 2014 Equity Incentive Plan In July 2014, the Company’s board of directors approved the 2014 Equity Incentive Plan (the “2014 Plan”). The number of shares of common stock reserved for issuance under the 2014 Plan will automatically increase on January 1 of each year, beginning on January 1, 2015, and continuing through and including January 1, 2024, by 3% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company’s board of directors. On January 1, 2018, the total number of shares of common stock reserved for issuance increased by 889,393 shares to 8,045,514 shares. A summary of the Company’s stock option activity and related information (options in thousands): Six Months Ended June 30, 2018 Options Weighted Average Outstanding, beginning of period 3,788 $ 16.28 Granted 695 35.43 Exercised (571 ) 13.38 Forfeited (93 ) 21.87 Outstanding, end of period 3,819 20.07 Exercisable 1,738 16.03 As of June 30, 2018, the aggregate pre-tax pre-tax A summary of the Company’s RSU activity and related information (RSUs in thousands): Six Months Ended June 30, 2018 RSUs Weighted Average Outstanding, beginning of period 275 $ 13.65 Awarded 194 35.61 Vested (100 ) 14.71 Forfeited (15 ) 22.69 Outstanding, end of period 354 24.98 As of June 30, 2018, the aggregate pre-tax Total stock-based compensation expense recognized is as follows (in thousands): Three Months Ended Six Months Ended 2018 2017 2018 2017 Cost of sales $ 330 $ 229 $ 590 $ 448 Selling, general and administrative 2,646 1,826 5,012 3,524 Research and development 629 414 1,141 800 $ 3,605 $ 2,469 $ 6,743 $ 4,772 As of June 30, 2018, the amount of unearned stock-based compensation currently estimated to be expensed through the year 2022 related to unvested employee stock-based awards was $28.4 million and the weighted average period over which the unearned stock-based compensation is expected to be recognized was 2.6 years. If there are any modifications or cancellations of the underlying unvested securities, the Company may be required to accelerate, increase or cancel any remaining unearned stock-based compensation expense. Future stock-based compensation expense and unearned stock-based compensation will increase to the extent that the Company grants additional share-based payments. 2014 Employee Stock Purchase Plan In July 2014, the Company’s board of directors approved the 2014 Employee Stock Purchase Plan (the “2014 ESPP”). A total of 496,092 shares were initially reserved for issuance under the 2014 ESPP. In June 2018, the Company’s stockholders approved the Amended and Restated 2014 ESPP, increasing the total number of shares of common stock reserved for issuance under the 2014 ESPP by 1,200,000 shares to a total of 1,696,092 shares (the “Amended and Restated 2014 ESPP”). A total of 86,571 shares were issued during the six months ended June 30, 2018. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 7. Net Loss per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and dilutive potential shares of common stock outstanding during the period. Because the Company has reported a net loss for all periods presented, diluted net loss per share is the same as basic net loss per share for those periods as all potentially dilutive securities were antidilutive in those periods. The following potentially dilutive securities outstanding have been excluded from the computations of weighted average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares, in thousands): Three Months Ended Six Months Ended 2018 2017 2018 2017 Common stock options 3,819 4,093 3,819 4,093 RSUs 354 285 354 285 ESPP shares 102 260 102 260 4,275 4,638 4,275 4,638 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Contingencies In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future, but have not yet been made. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such amounts can be reasonably estimated. Indemnification The Company’s amended and restated certificate of incorporation contains provisions limiting the liability of directors, and its amended and restated bylaws provide that the Company will indemnify each of its directors to the fullest extent permitted under Delaware law. The Company’s amended and restated certificate of incorporation and amended and restated bylaws also provide its board of directors with discretion to indemnify its officers and employees when determined appropriate by the board. In addition, the Company has entered and expects to continue to enter into agreements to indemnify its directors and executive officers. Litigation The Company is not currently a party to any material legal proceedings. The Company may at times be involved in litigation and other legal claims in the ordinary course of business. When appropriate in the Company’s estimation, it may record reserves in its financial statements for pending litigation and other claims. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9. Income Taxes The Company has a history of losses, and expects to record a loss in 2018, and therefore has not recorded a provision for income taxes. In December 2017, the U.S. government enacted comprehensive tax legislation, commonly referred to as the Tax Cuts and Jobs Act (“Tax Act”). The Tax Act makes broad and complex changes to the U.S. tax code, including, but not limited to, (1) reducing the U.S. federal corporate tax rate from 35 percent to 21 percent; (2) requiring companies to pay a one-time The Company has not historically had significant non-U.S. |
Summary of Significant Accoun15
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Basis of Preparation | Basis of Preparation The financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”). These financial statements include the accounts of the Company and its consolidated subsidiary. All intercompany balances and transactions have been eliminated in consolidation. The functional currency of Intersect ENT GmbH, which the Company established in June 2018, is the U.S. dollar. Transaction gains and losses are included in interest income and other, net, on the Company’s statements of operations. The interim financial data as of June 30, 2018, is unaudited and is not necessarily indicative of the results for the full year. In the opinion of the Company’s management, the interim data includes only normal and recurring adjustments necessary for a fair presentation of the Company’s financial results for the three and six months ended June 30, 2018 and 2017. Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to SEC rules and regulations relating to interim financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements. Management uses significant judgment when making estimates related to its revenue related allowances, common stock valuation and related stock-based compensation, as well as certain accrued liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. |
Significant Accounting Policies | Significant Accounting Policies There have been no significant changes to the accounting policies during the six months ended June 30, 2018, as compared to the significant accounting policies described in Note 2 of the “Notes to Financial Statements” in the Company’s audited financial statements included in its Annual Report, except as described below. |
Revenue Recognition | Revenue Recognition The Company adopted Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, The PROPEL family of products are regulated by the FDA as medical devices. The Company recognizes revenue through sales of its PROPEL family of products to hospitals and ambulatory surgery centers located almost entirely in the United States when control of the product is transferred to the customer, typically upon shipment of goods to the customer, satisfying the Company’s only performance obligation. The FDA has approved SINUVA as a pharmaceutical product and it is therefore regulated as such. The Company sells SINUVA to a limited number of specialty pharmacies and specialty distributors in the United States, (“Resellers”). These Resellers subsequently sell SINUVA to health care providers. Revenue from SINUVA sales are recognized when control of the product is transferred to the Resellers, typically upon receipt of goods by the Reseller, satisfying the Company’s only performance obligation. The Company recognizes product sales discounts, rebates, returns and other allowances as a reduction of revenue in the same period the related revenue is recognized. In addition to the agreements with the Resellers, the Company enters into arrangements with governmental agencies that result in rebates, chargebacks and discounts with respect to the purchase of SINUVA. These amounts include prompt pay discounts, Medicaid rebates, chargebacks related to Federal Supply Schedule of the General Services Administration and 340B of the Public Health Service Act as well as other allowances that may be offered within contracts between the Company and its direct or indirect customers relating to the Company’s sales of SINUVA, collectively referred to as “Discounts and Rebates.” Discounts and Rebates are based on amounts owed or expected to be owed on the related sales. These estimates take into consideration the Company’s historical experience, the shelf life of the product, current contractual and statutory requirements, specific known market events and trends and industry data. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect revenue and earnings in the period such variances become known. In the balance sheet, such amounts are generally classified as reductions of accounts receivable if the amount is payable to the Resellers, or a current liability if the amount is payable to a party other than the Reseller. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements There have been no significant changes to the disclosures in the recent accounting pronouncements during the six months ended June 30, 2018, as compared to the recent accounting pronouncements described in Note 2 of the “Notes to Financial Statements” in the Company’s audited financial statements included in its Annual Report. |
Composition of Certain Financ16
Composition of Certain Financial Statement Items (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Accounts Receivable | Accounts Receivable (in thousands): June 30, December 31, Accounts receivable $ 14,748 $ 16,739 Allowance for doubtful accounts (108 ) (150 ) $ 14,640 $ 16,589 |
Components of Inventory | Inventory (in thousands): June 30, December 31, Raw materials $ 1,515 $ 1,221 Work-in-process 279 302 Finished goods 7,339 6,951 $ 9,133 $ 8,474 |
Cash, Cash Equivalents and Sh17
Cash, Cash Equivalents and Short-term Investments (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Cash and Cash Equivalents [Abstract] | |
Summary of Cash, Cash Equivalents and Available-for-Sale Investments by Type of Instrument | The following is a summary of cash, cash equivalents and short-term investments, available-for-sale, June 30, 2018 December 31, 2017 Amortized Gross Unrealized Estimated Amortized Gross Unrealized Estimated Cost Gains Losses Fair Value Cost Gains Losses Fair Value Cash $ 9,379 $ — $ — $ 9,379 $ 7,646 $ — $ — $ 7,646 Money market funds 2,424 — — 2,424 12,191 — — 12,191 Corporate debt securities 46,605 — (79 ) 46,526 61,695 1 (69 ) 61,627 Commercial paper 46,576 4 (12 ) 46,568 20,880 — (24 ) 20,856 $ 104,984 $ 4 $ (91 ) $ 104,897 $ 102,412 $ 1 $ (93 ) $ 102,320 Reported as: Cash and cash equivalents $ 11,803 $ 19,837 Short-term investments, available-for-sale 93,094 82,483 $ 104,897 $ 102,320 |
Fair Value of Financial Instr18
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Summary of Cash, Cash Equivalents and Available-for-Sale Investments Measured at Fair Value on Recurring Basis | The following is a summary of cash, cash equivalents and short-term investments, available-for-sale, June 30, 2018 December 31, 2017 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Cash $ 9,379 $ — $ — $ 9,379 $ 7,646 $ — $ — $ 7,646 Money market funds 2,424 — — 2,424 12,191 — — 12,191 Corporate debt securities — 46,526 — 46,526 — 61,627 — 61,627 Commercial paper — 46,568 — 46,568 — 20,856 — 20,856 $ 11,803 $ 93,094 $ — $ 104,897 $ 19,837 $ 82,483 $ — $ 102,320 Reported as: Cash and cash equivalents $ 11,803 $ 19,837 Short-term investments, available-for-sale 93,094 82,483 $ 104,897 $ 102,320 |
Stock-based Compensation Expe19
Stock-based Compensation Expense (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Option Activity | A summary of the Company’s stock option activity and related information (options in thousands): Six Months Ended June 30, 2018 Options Weighted Average Outstanding, beginning of period 3,788 $ 16.28 Granted 695 35.43 Exercised (571 ) 13.38 Forfeited (93 ) 21.87 Outstanding, end of period 3,819 20.07 Exercisable 1,738 16.03 |
Summary of Restricted Stock Units Activity | A summary of the Company’s RSU activity and related information (RSUs in thousands): Six Months Ended June 30, 2018 RSUs Weighted Average Outstanding, beginning of period 275 $ 13.65 Awarded 194 35.61 Vested (100 ) 14.71 Forfeited (15 ) 22.69 Outstanding, end of period 354 24.98 |
Summary of Stock Based Compensation Expense | Total stock-based compensation expense recognized is as follows (in thousands): Three Months Ended Six Months Ended 2018 2017 2018 2017 Cost of sales $ 330 $ 229 $ 590 $ 448 Selling, general and administrative 2,646 1,826 5,012 3,524 Research and development 629 414 1,141 800 $ 3,605 $ 2,469 $ 6,743 $ 4,772 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially Dilutive Securities Outstanding Excluded from the Computations of Diluted Weighted Average Shares Outstanding | The following potentially dilutive securities outstanding have been excluded from the computations of weighted average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares, in thousands): Three Months Ended Six Months Ended 2018 2017 2018 2017 Common stock options 3,819 4,093 3,819 4,093 RSUs 354 285 354 285 ESPP shares 102 260 102 260 4,275 4,638 4,275 4,638 |
Composition of Certain Financ21
Composition of Certain Financial Statement Items - Accounts Receivable (Detail) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 | |
Receivables [Abstract] | |||
Accounts receivable | $ 14,748 | $ 16,739 | |
Allowance for doubtful accounts | (108) | (150) | |
Accounts receivable, net | $ 14,640 | $ 16,589 | [1] |
[1] | Amounts have been derived from the December 31, 2017 audited financial statements included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission. |
Composition of Certain Financ22
Composition of Certain Financial Statement Items - Components of Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 1,515 | $ 1,221 | |
Work-in-process | 279 | 302 | |
Finished goods | 7,339 | 6,951 | |
Inventory | $ 9,133 | $ 8,474 | [1] |
[1] | Amounts have been derived from the December 31, 2017 audited financial statements included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission. |
Cash, Cash Equivalents and Sh23
Cash, Cash Equivalents and Short-term Investments - Summary of Cash, Cash Equivalents and Available-for-Sale Investments by Type of Instrument (Detail) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 | Jun. 30, 2017 | Dec. 31, 2016 | |
Net Investment [Line Items] | |||||
Cash, cash equivalents and available-for-sale investments, Amortized Cost | $ 104,984 | $ 102,412 | |||
Cash, cash equivalents and available-for-sale investments, Gross Unrealized Gains | 4 | 1 | |||
Cash, cash equivalents and available-for-sale investments, Gross Unrealized Losses | (91) | (93) | |||
Cash, cash equivalents and available-for-sale investments, Estimated Fair Value | 104,897 | 102,320 | |||
Cash, cash equivalents, Estimated Fair Value | 11,803 | 19,837 | [1] | $ 14,023 | $ 9,859 |
Short-term investments, available-for-sale, Estimated Fair Value | 93,094 | 82,483 | [1] | ||
Cash and cash equivalents and short-term investments, available-for-sale | 104,897 | 102,320 | |||
Cash [Member] | |||||
Net Investment [Line Items] | |||||
Cash, cash equivalents and available-for-sale investments, Amortized Cost | 9,379 | 7,646 | |||
Cash, cash equivalents and available-for-sale investments, Estimated Fair Value | 9,379 | 7,646 | |||
Money Market Funds [Member] | |||||
Net Investment [Line Items] | |||||
Cash, cash equivalents and available-for-sale investments, Amortized Cost | 2,424 | 12,191 | |||
Cash, cash equivalents and available-for-sale investments, Estimated Fair Value | 2,424 | 12,191 | |||
Corporate Debt Securities [Member] | |||||
Net Investment [Line Items] | |||||
Cash, cash equivalents and available-for-sale investments, Amortized Cost | 46,605 | 61,695 | |||
Cash, cash equivalents and available-for-sale investments, Gross Unrealized Gains | 1 | ||||
Cash, cash equivalents and available-for-sale investments, Gross Unrealized Losses | (79) | (69) | |||
Cash, cash equivalents and available-for-sale investments, Estimated Fair Value | 46,526 | 61,627 | |||
Commercial Paper [Member] | |||||
Net Investment [Line Items] | |||||
Cash, cash equivalents and available-for-sale investments, Amortized Cost | 46,576 | 20,880 | |||
Cash, cash equivalents and available-for-sale investments, Gross Unrealized Gains | 4 | ||||
Cash, cash equivalents and available-for-sale investments, Gross Unrealized Losses | (12) | (24) | |||
Cash, cash equivalents and available-for-sale investments, Estimated Fair Value | $ 46,568 | $ 20,856 | |||
[1] | Amounts have been derived from the December 31, 2017 audited financial statements included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission. |
Cash, Cash Equivalents and Sh24
Cash, Cash Equivalents and Short-term Investments - Additional Information (Detail) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2018 | Dec. 31, 2017 | |
Investments Schedule [Abstract] | ||
Investments with a contractual maturity of greater than one year | $ 0 | $ 0 |
Other-than-temporary impairment charges | $ 0 | $ 0 |
Fair Value of Financial Instr25
Fair Value of Financial Instruments - Summary of Cash, Cash Equivalents and Short-Term Investments Available-for-Sale, by Type of Instrument (Detail) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 | Jun. 30, 2017 | Dec. 31, 2016 | |
Net Investment [Line Items] | |||||
Cash and cash equivalents | $ 11,803 | $ 19,837 | [1] | $ 14,023 | $ 9,859 |
Short-term investments, available-for-sale | 93,094 | 82,483 | [1] | ||
Cash and cash equivalents and short-term investments, available-for-sale | 104,897 | 102,320 | |||
Fair Value on Recurring Basis [Member] | |||||
Net Investment [Line Items] | |||||
Cash and cash equivalents | 11,803 | 19,837 | |||
Short-term investments, available-for-sale | 93,094 | 82,483 | |||
Cash and cash equivalents and short-term investments, available-for-sale | 104,897 | 102,320 | |||
Fair Value on Recurring Basis [Member] | Cash [Member] | |||||
Net Investment [Line Items] | |||||
Cash and cash equivalents and short-term investments, available-for-sale | 9,379 | 7,646 | |||
Fair Value on Recurring Basis [Member] | Money Market Funds [Member] | |||||
Net Investment [Line Items] | |||||
Cash and cash equivalents and short-term investments, available-for-sale | 2,424 | 12,191 | |||
Fair Value on Recurring Basis [Member] | Corporate Debt Securities [Member] | |||||
Net Investment [Line Items] | |||||
Cash and cash equivalents and short-term investments, available-for-sale | 46,526 | 61,627 | |||
Fair Value on Recurring Basis [Member] | Commercial Paper [Member] | |||||
Net Investment [Line Items] | |||||
Cash and cash equivalents and short-term investments, available-for-sale | 46,568 | 20,856 | |||
Level 1 [Member] | Fair Value on Recurring Basis [Member] | |||||
Net Investment [Line Items] | |||||
Cash and cash equivalents and short-term investments, available-for-sale | 11,803 | 19,837 | |||
Level 1 [Member] | Fair Value on Recurring Basis [Member] | Cash [Member] | |||||
Net Investment [Line Items] | |||||
Cash and cash equivalents and short-term investments, available-for-sale | 9,379 | 7,646 | |||
Level 1 [Member] | Fair Value on Recurring Basis [Member] | Money Market Funds [Member] | |||||
Net Investment [Line Items] | |||||
Cash and cash equivalents and short-term investments, available-for-sale | 2,424 | 12,191 | |||
Level 2 [Member] | Fair Value on Recurring Basis [Member] | |||||
Net Investment [Line Items] | |||||
Cash and cash equivalents and short-term investments, available-for-sale | 93,094 | 82,483 | |||
Level 2 [Member] | Fair Value on Recurring Basis [Member] | Corporate Debt Securities [Member] | |||||
Net Investment [Line Items] | |||||
Cash and cash equivalents and short-term investments, available-for-sale | 46,526 | 61,627 | |||
Level 2 [Member] | Fair Value on Recurring Basis [Member] | Commercial Paper [Member] | |||||
Net Investment [Line Items] | |||||
Cash and cash equivalents and short-term investments, available-for-sale | $ 46,568 | $ 20,856 | |||
[1] | Amounts have been derived from the December 31, 2017 audited financial statements included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission. |
Fair Value of Financial Instr26
Fair Value of Financial Instruments - Additional Information (Detail) - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 |
Fair Value Disclosures [Abstract] | ||
Transfer of assets from level 1 to level 2 | $ 0 | $ 0 |
Transfer of liabilities from level 1 to level 2 | 0 | 0 |
Transfer of assets from level 2 to level 1 | 0 | 0 |
Transfer of liabilities from level 2 to level 1 | $ 0 | $ 0 |
Stock-based Compensation Expe27
Stock-based Compensation Expense - Additional Information (Detail) - USD ($) $ in Millions | Jan. 01, 2018 | Jun. 30, 2018 | Jun. 30, 2018 | Jun. 30, 2017 | Jul. 23, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unearned stock-based compensation | $ 28.4 | $ 28.4 | |||
Weighted average period for unearned stock-based compensation to be recognized | 2 years 7 months 6 days | ||||
RSUs [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Aggregate pre-tax intrinsic value of RSUs outstanding | 13.3 | $ 13.3 | |||
Weighted-average remaining contractual term of RSUs outstanding | 2 years 3 months 19 days | ||||
Common Stock Options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Aggregate pre-tax intrinsic value of options outstanding and exercisable | 37.2 | $ 37.2 | |||
Aggregate pre-tax intrinsic value of options outstanding | $ 66.5 | 66.5 | |||
Aggregate pre-tax intrinsic value of options exercised | $ 13.8 | $ 6.8 | |||
Weighted-average remaining contractual term of options outstanding | 7 years 9 months 18 days | ||||
Weighted-average remaining contractual term of options exercisable | 6 years 10 months 25 days | ||||
2014 Employee Stock Purchase Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock, capital shares reserved for future issuance, increase during period | 1,200,000 | ||||
Shares authorized for future issuance | 1,696,092 | 1,696,092 | 496,092 | ||
Shares Issued | 86,571 | ||||
2014 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage of shares outstanding | 3.00% | ||||
Common stock, capital shares reserved for future issuance, increase during period | 889,393 | ||||
Shares reserved for issuance | 8,045,514 | 8,045,514 | 8,045,514 |
Stock-based Compensation Expe28
Stock-based Compensation Expense - Summary of Stock Option Activity (Detail) - Common Stock Options [Member] shares in Thousands | 6 Months Ended |
Jun. 30, 2018$ / sharesshares | |
Class of Stock [Line Items] | |
Options outstanding, beginning of period | shares | 3,788 |
Options granted | shares | 695 |
Options exercised | shares | (571) |
Options forfeited | shares | (93) |
Options outstanding, end of period | shares | 3,819 |
Options exercisable | shares | 1,738 |
Options price, outstanding, beginning of period | $ / shares | $ 16.28 |
Options price, granted | $ / shares | 35.43 |
Options price, exercised | $ / shares | 13.38 |
Options price, forfeited | $ / shares | 21.87 |
Options price, outstanding, end of period | $ / shares | 20.07 |
Options price, exercisable | $ / shares | $ 16.03 |
Stock-based Compensation Expe29
Stock-based Compensation Expense - Summary of Restricted Stock Units Activity (Detail) - RSUs [Member] shares in Thousands | 6 Months Ended |
Jun. 30, 2018$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding, beginning of period | shares | 275 |
Awarded | shares | 194 |
Vested | shares | (100) |
Forfeited | shares | (15) |
Outstanding, end of period | shares | 354 |
Outstanding, beginning of period | $ / shares | $ 13.65 |
Awarded | $ / shares | 35.61 |
Vested | $ / shares | 14.71 |
Forfeited | $ / shares | 22.69 |
Outstanding, end of period | $ / shares | $ 24.98 |
Stock-based Compensation Expe30
Stock-based Compensation Expense - Summary of Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 3,605 | $ 2,469 | $ 6,743 | $ 4,772 |
Cost of Sales [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 330 | 229 | 590 | 448 |
Selling, General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 2,646 | 1,826 | 5,012 | 3,524 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 629 | $ 414 | $ 1,141 | $ 800 |
Net Loss per Share - Schedule o
Net Loss per Share - Schedule of Potentially Dilutive Securities Outstanding Excluded from the Computations of Diluted Weighted Average Shares Outstanding (Detail) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding | 4,275 | 4,638 | 4,275 | 4,638 |
Common Stock Options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding | 3,819 | 4,093 | 3,819 | 4,093 |
RSUs [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding | 354 | 285 | 354 | 285 |
2014 Employee Stock Purchase Plan [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding | 102 | 260 | 102 | 260 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Provision for income taxes | $ 0 | |
U.S. federal corporate tax rate | 21.00% | 35.00% |