Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Oct. 31, 2016 | |
Document Information [Line Items] | ||
Entity Registrant Name | PROTEON THERAPEUTICS INC | |
Entity Central Index Key | 1,359,931 | |
Trading Symbol | prto | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Voluntary Filers | No | |
Entity Well-known Seasoned Issuer | No | |
Entity Common Stock, Shares Outstanding (in shares) | 16,594,445 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 26,678,000 | $ 40,031,000 |
Available-for-sale investments | 20,296,000 | 25,232,000 |
Prepaid expenses and other current assets | 1,749,000 | 1,345,000 |
Total current assets | 48,723,000 | 66,608,000 |
Property and equipment, net | 396,000 | 224,000 |
Other non-current assets | 276,000 | 706,000 |
Total assets | 49,395,000 | 67,538,000 |
Current liabilities: | ||
Accounts payable | 591,000 | 1,020,000 |
Accrued expenses | 4,186,000 | 2,576,000 |
Other current liabilities | 98,000 | 537,000 |
Total current liabilities | 4,942,000 | 4,133,000 |
Total liabilities | 4,942,000 | 4,133,000 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value per share; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2016 and December 31, 2015 | 0 | 0 |
Common stock, $0.001 par value, 100,000,000 shares authorized at September 30, 2016 and December 31, 2015; 16,582,999 and 16,501,500 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | 17,000 | 16,000 |
Additional paid-in capital | 197,310,000 | 194,651,000 |
Accumulated deficit | (152,815,000) | (131,251,000) |
Accumulated other comprehensive income (loss) | 8,000 | (11,000) |
Total stockholders’ equity | 44,453,000 | 63,405,000 |
Total liabilities and stockholders’ equity | $ 49,395,000 | $ 67,538,000 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 16,582,999 | 16,501,500 |
Common stock, shares oustanding (in shares) | 16,582,999 | 16,501,500 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Research and Development Expense [Member] | ||||
Included in operating expenses, above, are the following amounts for non-cash stock based compensation expense: | ||||
Allocated share-based compensation | $ 168 | $ 184 | $ 797 | $ 431 |
General and Administrative Expense [Member] | ||||
Included in operating expenses, above, are the following amounts for non-cash stock based compensation expense: | ||||
Allocated share-based compensation | 519 | 427 | 1,702 | 1,063 |
Research and development | 4,842 | 3,078 | 14,432 | 8,801 |
General and administrative | 2,324 | 2,004 | 7,407 | 5,882 |
Total operating expenses | 7,166 | 5,082 | 21,839 | 14,683 |
Loss from operations | (7,166) | (5,082) | (21,839) | (14,683) |
Investment income | 46 | 34 | 155 | 111 |
Other income (expense), net | 13 | (335) | 120 | (463) |
Total other income (expense) | 59 | (301) | 275 | (352) |
Net loss | (7,107) | (5,383) | (21,564) | (15,035) |
Unrealized (loss) gain on available-for-sale investments | (2) | 3 | 19 | 12 |
Comprehensive loss | (7,109) | (5,380) | (21,545) | (15,023) |
Net loss attributable to common stockholders | $ (7,107) | $ (5,383) | $ (21,564) | $ (15,035) |
Net loss per share attributable to common stockholders - basic and diluted (in dollars per share) | $ (0.43) | $ (0.33) | $ (1.30) | $ (0.91) |
Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted (in shares) | 16,582,276 | 16,466,945 | 16,550,483 | 16,455,257 |
Allocated share-based compensation | $ 687 | $ 611 | $ 2,499 | $ 1,494 |
Included in other (expense) income, net, above, are the following amounts from forward foreign currency contracts: | ||||
Realized losses from forward foreign currency contracts | (4) | (8) | (14) | |
Unrealized gains (losses) from forward foreign currency contracts | 2 | (314) | 127 | (426) |
Total | $ (2) | $ (314) | $ 119 | $ (440) |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Operating activities | ||
Net loss | $ (21,564,000) | $ (15,035,000) |
Reconciliation of net loss to net cash used in operating activities: | ||
Depreciation | 87,000 | 33,000 |
Amortization of premium/discount on available-for-sale securities | 108,000 | 580,000 |
Unrealized (gain) loss on forward foreign currency contracts included in net income | (127,000) | 426,000 |
Foreign currency remeasurement (gain) loss | (6,000) | 29,000 |
Stock-based compensation | 2,499,000 | 1,494,000 |
Changes in: | ||
Prepaid expenses and other assets | (20,000) | (181,000) |
Interest receivable | 46,000 | (214,000) |
Accounts payable, accrued expenses and other current liabilities | 869,000 | 488,000 |
Net cash used in operating activities | (18,108,000) | (12,380,000) |
Investing activities | ||
Purchases of available-for-sale investments | (39,756,000) | (66,136,000) |
Proceeds from maturities of available-for-sale investments | 44,603,000 | 43,752,000 |
Proceeds from sale of available-for-sale investments | 2,006,000 | |
Purchase of property and equipment | (259,000) | (171,000) |
Net cash provided by (used in) investing activities | 4,588,000 | (20,549,000) |
Financing activities | ||
Exercise of stock options | 156,000 | 49,000 |
Proceeds from issuance of common stock under ESPP | 5,000 | 52,000 |
Net cash provided by financing activities | 161,000 | 101,000 |
Effect of exchange rate changes on cash | 6,000 | (29,000) |
Decrease in cash and cash equivalents | (13,353,000) | (32,857,000) |
Cash and cash equivalents, beginning of period | 40,031,000 | 68,840,000 |
Cash and cash equivalents, end of period | $ 26,678,000 | $ 35,983,000 |
Note 1 - Organization and Opera
Note 1 - Organization and Operations | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Nature of Operations [Text Block] | 1. Organization and Operations The Company Proteon Therapeutics, Inc. (the “Company”) is a late-stage biopharmaceutical company focused on the development of novel, first-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular disease. The Company was formed in June 2001 and incorporated on March 24, 2006. Since inception, the Company has devoted substantially all of its efforts to product research and development, initial market development and raising capital. The Company has not generated any product revenue related to its primary business purpose to date and is subject to a number of risks similar to those of other development stage companies, including dependence on key individuals, competition from other companies, the need for development of commercially viable products and the need to obtain adequate additional financing to fund the development of its product candidates. The Company is also subject to a number of risks similar to other companies in the biotechnology industry, including regulatory approval of products, uncertainty of market acceptance of products, competition from substitute products and larger companies, the need to obtain additional financing, compliance with government regulations, protection of proprietary technology, dependence on third parties, product liability and dependence on key individuals. On April 20, 2016, the Company formed a wholly-owned holding company in Delaware, Proteon International Holdings, Inc. (“Proteon International”). On May 4, 2016, Proteon International formed a wholly-owned subsidiary company in Bermuda, Proteon Bermuda Limited (“Proteon Bermuda”). On June 2, 2016, Proteon Bermuda formed a wholly-owned subsidiary company in Ireland, Proteon Ireland Limited. As of September 30, 2016, the Company had cash, cash equivalents and available-for-sale investments of $47.0 million. The Company believes that its existing cash, cash equivalents and available-for-sale investments will be sufficient to fund operations and capital expenditures into the fourth quarter of 2017. The Company had an accumulated deficit of $152.8 million as of September 30, 2016. On November 12, 2015, the Company filed a shelf registration statement on Form S-3 (the “Registration Statement”), and entered into a Sales Agreement with Cowen and Company, LLC (the "Sales Agreement") to establish an at-the-market (“ATM”) equity offering program pursuant to which they are able, with the Company’s authorization, to offer and sell up to $40 million of the Company’s Common Stock at prevailing market prices from time to time. The Registration Statement became effective on January 12, 2016. As of September 30, 2016, the Company had not commenced sales under this program. |
Note 2 - Summary of Significant
Note 2 - Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 2. Summary of Significant Accounting Policies Basis of Presentation, Principles of Consolidation and Use of Estimates The unaudited interim condensed consolidated financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the financial statements as of and for the year ended December 31, 2015 and notes thereto, included in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 14, 2016. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to fairly present the Company’s financial position as of September 30, 2016, the results of its operations for the three and nine months ended September 30, 2016 and 2015 and its cash flows for the nine months ended September 30, 2016 and 2015. Such adjustments are of a normal and recurring nature. The results for the three and nine months ended September 30, 2016 are not necessarily indicative of the results for the year ending December 31, 2016, or for any future period. The unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not limited to, estimates related to stock-based compensation expense, clinical trial accruals and reported amounts of revenues and expenses during the reported period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, available-for-sale investments, forward foreign currency contracts (see Note 4), accounts payable, and accrued liabilities. The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. FASB ASC Topic 820, Fair Value Measurement and Disclosures · Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. · Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly. · Level 3—Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Financial instruments measured at fair value on a recurring basis include cash equivalents, short-term investments and forward foreign currency contracts (see Note 4). There have been no changes to the valuation methods utilized by the Company during the nine months ended September 30, 2016 and 2015. The Company evaluates transfers between levels at the end of each reporting period. There were no transfers of financial instruments between levels during the nine months ended September 30, 2016 and 2015. Derivative Financial Instruments The Company enters into forward foreign currency contracts to mitigate its exposure to fluctuations in the exchange rates between the Swiss Franc and the U.S. dollar (see Note 4). The Company records these derivative financial instruments on the consolidated balance sheets at fair value. Although these derivative contracts are intended to economically hedge foreign exchange risk, the Company has not elected to apply hedge accounting. As such, changes in the fair value of these instruments are recorded directly in earnings as a component of other income (expense), as they occur. The Company executes its derivative instruments with financial institutions that the Company judges to be credit-worthy, defined as institutions that hold an investment-grade credit rating. Recent Accounting Pronouncements In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers In August 2014, the FASB issued ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842): Amendments to FASB Codification In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments There have been no other material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 14, 2016. |
Note 3 - Fair Value Measurement
Note 3 - Fair Value Measurements | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | 3. Fair Value Measurements Below is a summary of assets and liabilities measured at fair value (in thousands): As of September 30, 2016 Quoted Prices Significant Significant Total Assets Cash equivalents $ 18,118 $ - $ - $ 18,118 Government securities 20,296 - - 20,296 Total $ 38,414 $ - $ - $ 38,414 Liabilities Forward foreign currency contracts $ - $ 98 $ - $ 98 Total $ - $ 98 $ - $ 98 As of December 31, 2015 Quoted Prices Significant Significant Total Assets Cash equivalents $ 39,233 $ - $ - $ 39,233 Government securities 25,232 - - 25,232 Total $ 64,465 $ - $ - $ 64,465 Liabilities Forward foreign currency contracts $ - $ 537 $ - $ 537 Total $ - $ 537 $ - $ 537 As of September 30, 2016 and December 31, 2015, the Company’s cash equivalents consist principally of money market funds and government debt securities with original maturities of 90 days or less. Government securities consist principally of government debt securities and money market funds which are classified as available-for-sale. Forward foreign currency contracts consist of contracts with credit-worthy financial institutions to buy Swiss Francs with U.S. dollars in the future at agreed upon exchange rates. Forward foreign currency contracts are stated at fair value and consist of Level 2 financial instruments in the fair value hierarchy. The Company determines the fair value of its forward foreign currency contracts based on pricing from a service provider. The service provider values the instruments based on market prices from a variety of industry-standard independent data providers. Such market prices are based on inputs other than quoted prices included within Level 1 that are observable for the asset, either directly or indirectly (Level 2 inputs). Cash equivalents and government securities are stated at fair value and consist of Level 1 financial instruments in the fair value hierarchy. The Company determined the fair value of its debt security holdings based on pricing from a service provider. The service provider values the securities based on market prices from a variety of industry-standard independent data providers. These market prices are quoted prices in active markets for identical assets (Level 1 inputs). Available-for-sale securities at September 30, 2016 and December 31, 2015 consist of the following (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Fair Value September 30, 2016 Government securities (Due within 1 year) $ 20,288 $ 8 $ - $ 20,296 $ 20,288 $ 8 $ - $ 20,296 December 31, 2015 Government securities (Due within 1 year) $ 25,243 $ 1 $ (12 ) $ 25,232 $ 25,243 $ 1 $ (12 ) $ 25,232 |
Note 4 - Derivative Financial I
Note 4 - Derivative Financial Instruments | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Derivative Instruments and Hedging Activities Disclosure [Text Block] | 4. Derivative Financial Instruments The Company enters into forward foreign currency contracts to mitigate its exposure to fluctuations in the U.S dollar value of forecasted transactions denominated in Swiss Franc. During the nine months ended September 30, 2016, the Company had forward foreign currency contract activity for which it did not elect hedge accounting for the forward foreign currency contracts outstanding as of September 30, 2016, but may elect to apply hedge accounting in the future. As a result, during the nine months ended September 30, 2016, the Company experienced unrealized gains within other income (expense) in the consolidated statements of operations from the mark-to-market of outstanding forward foreign currency contracts. The Company expects potential volatility within other income (expense) in future periods for contracts for which the Company does not apply hedge accounting. As of September 30, 2016, the Company had the following outstanding forward foreign currency contract that was not designated for hedge accounting and that was used to reduce the exposure to fluctuations in the U.S dollar value of forecasted transactions denominated in Swiss Franc (dollars in thousands): Notional Amount Effective Date Maturity Date Number of $ 1,265 June 12, 2015 December 15, 2016 1 No forward foreign currency contracts were held by the Company prior to May 2015. The table below presents the fair value of the Company’s derivative financial instrument as well as its classification on the balance sheet as of September 30, 2016 (in thousands): Balance Sheet line item Gross amounts Gross amount Net Amount Forward foreign currency contracts Other current liabilities $ 98 $ - $ 98 |
Note 5 - Commitments and Contin
Note 5 - Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 5. Commitments and Contingencies In July 2015, the Company entered into a manufacturing services agreement with Lonza Ltd (“Lonza”) for the processing, development and manufacturing of the active pharmaceutical ingredient (“API”) in its lead product candidate, vonapanitase. Under the agreement, the Company will issue purchase orders authorizing Lonza to manufacture API batches and will pay for the services and batches in accordance with terms and assumptions in the agreement and to be set forth in a project plan. As of September 30, 2016, the Company has issued a purchase order for 1.9 million Swiss Francs for the manufacturing of one batch which commenced in June 2016 and substantially finished in the third quarter of 2016. The Company has made payments of 1.0 million Swiss Francs and accrued 0.8 million Swiss Francs for the manufacturing services rendered under the agreement as of September 30, 2016. Additionally, in connection with this transaction, the Company has issued a purchase order of 0.2 million Swiss Francs, related to Lonza’s acquisition of raw materials used within manufacturing of this batch. The related costs have been reflected within accrued expenses in its consolidated balance sheet as of September 30, 2016. Lastly, the Company has issued a purchase order for 7.6 million Swiss Francs, approximately $7.8 million at current exchange rates, for the manufacturing of four batches to commence in June 2017. No services have been rendered under this purchase order as of September 30, 2016. Future minimum payments required under operating leases as of September 30, 2016 are summarized as follows (in thousands): Year Ending December 31: Amount 2016 $ 42 2017 168 2018 84 Total minimum lease payments $ 294 Rental expense for the nine months ended September 30, 2016 and 2015 was $136,000 and $139,000, respectively. In addition to the base rent, the Company is also responsible for its share of operating expenses and real estate taxes, in accordance with the terms of the lease agreement. As of September 30, 2016, the Company has provided a security deposit in the amount of $14,000 to the lessor. At September 30, 2016 and December 31, 2015, the Company had $14,000 in an outstanding letter of credit to be used as collateral for leased premises. At September 30, 2016 and December 31, 2015, the Company pledged an aggregate of $14,000 to the bank as collateral for the letter of credit, which is included in long-term assets. |
Note 6 - Stock-based Compensati
Note 6 - Stock-based Compensation | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 6. Stock-based Compensation Stock Options The following table summarizes stock option activity for employees and non-employees: Options Weighted- Weighted- Aggregate Outstanding at December 31, 2015 2,200,369 $ 8.52 7.8 $ 15,705 Granted 119,162 $ 6.90 Exercised (80,825 ) $ 1.91 Cancelled or forfeited (69,089 ) $ 14.12 Outstanding at September 30, 2016 2,169,617 $ 8.50 7.3 $ 5,814 Exercisable at September 30, 2016 1,055,385 $ 5.81 5.8 $ 4,619 Vested or expected to vest at September 30, 2016 (1) 2,033,481 $ 8.29 7.2 $ 5,697 ________________ (1) Represents the number of vested options at September 30, 2016 plus the number of unvested options expected to vest based on the unvested options outstanding at September 30, 2016. Employee Stock Purchase Plan The 2014 Employee Stock Purchase Plan (ESPP) initially authorized the issuance of up to 140,500 shares of Common Stock. The number of shares increases each January 1, commencing on January 1, 2015 and ending on (and including) January 1, 2024, by an amount equal to the lesser of one percent of the outstanding shares as of the end of the immediately preceding fiscal year, 281,000 shares, or any lower amount determined by the Company’s Board of Directors prior to each such January 1st. The Company’s Board of Directors has determined there was to be no increase on January 1, 2016. As of September 30, 2016, the 2014 ESPP authorized the issuance of up to 304,991 shares of Common Stock. The first offering under the 2014 ESPP began on January 1, 2015 and ended on June 30, 2015. During the nine months ended September 30, 2016, 674 shares were issued under the 2014 ESPP with 296,685 shares remaining for future issuance under the plan as of September 30, 2016. Common Stock The Company has the following shares reserved for future issuance: September 30, December 31, Stock-based compensation awards 2,999,166 2,419,901 Employee Stock Purchase Plan 296,685 297,359 Total 3,295,851 2,717,260 |
Note 7 - Income Taxes
Note 7 - Income Taxes | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 7. Income Taxes Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The Company has evaluated the positive and negative evidence bearing upon the Company’s ability to realize the benefit of its deferred tax assets. Based on the Company’s history of operating losses, the Company has concluded that it is more likely than not that the benefit of its deferred tax assets will not be realized. Due to the uncertainty surrounding the realization of the favorable tax attributes in future tax returns, the Company has provided a full valuation allowance against its deferred tax assets. There were no significant income tax provisions or benefits for the nine months ended September 30, 2016 and 2015. |
Note 8 - Net Loss Per Share Att
Note 8 - Net Loss Per Share Attributable to Common Stockholders | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 8. Net Loss per Share Attributable to Common Stockholders The Company computes basic and diluted loss per share using a methodology that gives effect to the impact of outstanding participating securities (the “two-class method”). As the three and nine months ended September 30, 2016 and 2015 resulted in net losses, there is no income allocation required under the two-class method or dilution attributed to weighted-average shares outstanding in the calculation of diluted loss per share. The following Common Stock equivalents, presented on an as converted basis, were excluded from the calculation of net loss per share for the periods presented, due to their anti-dilutive effect: Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Outstanding stock options 2,169,617 1,800,262 2,169,617 1,800,262 Outstanding ESPP shares 10,913 1,097 10,913 1,097 2,180,530 1,801,359 2,180,530 1,801,359 |
Note 9 - Subsequent Events
Note 9 - Subsequent Events | 9 Months Ended |
Sep. 30, 2016 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | 9. Subsequent Events The Company has evaluated all activity that occurred subsequent to quarter end but prior to issuance of the unaudited condensed consolidated financial statements for events or transactions that could require disclosure or that could impact the carrying value of assets or liabilities as of the balance sheet date. In the judgment of management, there were no material events that impacted the unaudited condensed financial statements or disclosures. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation, Principles of Consolidation and Use of Estimates The unaudited interim condensed consolidated financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the financial statements as of and for the year ended December 31, 2015 and notes thereto, included in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 14, 2016. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to fairly present the Company’s financial position as of September 30, 2016, the results of its operations for the three and nine months ended September 30, 2016 and 2015 and its cash flows for the nine months ended September 30, 2016 and 2015. Such adjustments are of a normal and recurring nature. The results for the three and nine months ended September 30, 2016 are not necessarily indicative of the results for the year ending December 31, 2016, or for any future period. The unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. These condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not limited to, estimates related to stock-based compensation expense, clinical trial accruals and reported amounts of revenues and expenses during the reported period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. |
Fair Value Measurement, Policy [Policy Text Block] | Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, available-for-sale investments, forward foreign currency contracts (see Note 4), accounts payable, and accrued liabilities. The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. FASB ASC Topic 820, Fair Value Measurement and Disclosures · Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. · Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly. · Level 3—Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Financial instruments measured at fair value on a recurring basis include cash equivalents, short-term investments and forward foreign currency contracts (see Note 4). There have been no changes to the valuation methods utilized by the Company during the nine months ended September 30, 2016 and 2015. The Company evaluates transfers between levels at the end of each reporting period. There were no transfers of financial instruments between levels during the nine months ended September 30, 2016 and 2015. |
Derivatives, Policy [Policy Text Block] | Derivative Financial Instruments The Company enters into forward foreign currency contracts to mitigate its exposure to fluctuations in the exchange rates between the Swiss Franc and the U.S. dollar (see Note 4). The Company records these derivative financial instruments on the consolidated balance sheets at fair value. Although these derivative contracts are intended to economically hedge foreign exchange risk, the Company has not elected to apply hedge accounting. As such, changes in the fair value of these instruments are recorded directly in earnings as a component of other income (expense), as they occur. The Company executes its derivative instruments with financial institutions that the Company judges to be credit-worthy, defined as institutions that hold an investment-grade credit rating. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers In August 2014, the FASB issued ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842): Amendments to FASB Codification In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments There have been no other material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 14, 2016. |
Note 3 - Fair Value Measureme16
Note 3 - Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Notes Tables | |
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | As of September 30, 2016 Quoted Prices Significant Significant Total Assets Cash equivalents $ 18,118 $ - $ - $ 18,118 Government securities 20,296 - - 20,296 Total $ 38,414 $ - $ - $ 38,414 Liabilities Forward foreign currency contracts $ - $ 98 $ - $ 98 Total $ - $ 98 $ - $ 98 As of December 31, 2015 Quoted Prices Significant Significant Total Assets Cash equivalents $ 39,233 $ - $ - $ 39,233 Government securities 25,232 - - 25,232 Total $ 64,465 $ - $ - $ 64,465 Liabilities Forward foreign currency contracts $ - $ 537 $ - $ 537 Total $ - $ 537 $ - $ 537 |
Available-for-sale Securities [Table Text Block] | Amortized Cost Unrealized Gains Unrealized Losses Fair Value September 30, 2016 Government securities (Due within 1 year) $ 20,288 $ 8 $ - $ 20,296 $ 20,288 $ 8 $ - $ 20,296 December 31, 2015 Government securities (Due within 1 year) $ 25,243 $ 1 $ (12 ) $ 25,232 $ 25,243 $ 1 $ (12 ) $ 25,232 |
Note 4 - Derivative Financial17
Note 4 - Derivative Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Notes Tables | |
Schedule of Derivative Instruments [Table Text Block] | Notional Amount Effective Date Maturity Date Number of $ 1,265 June 12, 2015 December 15, 2016 1 |
Schedule of Derivative Instruments in Statement of Financial Position, Fair Value [Table Text Block] | Balance Sheet line item Gross amounts Gross amount Net Amount Forward foreign currency contracts Other current liabilities $ 98 $ - $ 98 |
Note 5 - Commitments and Cont18
Note 5 - Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Notes Tables | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | Year Ending December 31: Amount 2016 $ 42 2017 168 2018 84 Total minimum lease payments $ 294 |
Note 6 - Stock-based Compensa19
Note 6 - Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Notes Tables | |
Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block] | Options Weighted- Weighted- Aggregate Outstanding at December 31, 2015 2,200,369 $ 8.52 7.8 $ 15,705 Granted 119,162 $ 6.90 Exercised (80,825 ) $ 1.91 Cancelled or forfeited (69,089 ) $ 14.12 Outstanding at September 30, 2016 2,169,617 $ 8.50 7.3 $ 5,814 Exercisable at September 30, 2016 1,055,385 $ 5.81 5.8 $ 4,619 Vested or expected to vest at September 30, 2016 (1) 2,033,481 $ 8.29 7.2 $ 5,697 |
Common Stock Reserved for Future Issuance [Table Text Block] | September 30, December 31, Stock-based compensation awards 2,999,166 2,419,901 Employee Stock Purchase Plan 296,685 297,359 Total 3,295,851 2,717,260 |
Note 8 - Net Loss Per Share A20
Note 8 - Net Loss Per Share Attributable to Common Stockholders (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Outstanding stock options 2,169,617 1,800,262 2,169,617 1,800,262 Outstanding ESPP shares 10,913 1,097 10,913 1,097 2,180,530 1,801,359 2,180,530 1,801,359 |
Note 1 - Organization and Ope21
Note 1 - Organization and Operations (Details Textual) - USD ($) | Nov. 12, 2015 | Sep. 30, 2016 | Dec. 31, 2015 |
Sales Agreement [Member] | Cowen and Company, LLC [Member] | |||
Sale of Stock, Maximum Value of Stock Offered | $ 40,000,000 | ||
Cash, Cash Equivalents, and Short-term Investments | $ 47,000,000 | ||
Retained Earnings (Accumulated Deficit) | $ (152,815,000) | $ (131,251,000) |
Note 3 - Fair Value Measureme22
Note 3 - Fair Value Measurements - Summary of Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Fair Value, Inputs, Level 1 [Member] | Cash Equivalents [Member] | ||
Cash equivalents | $ 18,118 | $ 39,233 |
Fair Value, Inputs, Level 1 [Member] | US Government Agencies Debt Securities [Member] | ||
Government securities | 20,296 | 25,232 |
Fair Value, Inputs, Level 1 [Member] | ||
Total | 38,414 | 64,465 |
Forward foreign currency contracts | ||
Total | ||
Fair Value, Inputs, Level 2 [Member] | Cash Equivalents [Member] | ||
Cash equivalents | ||
Fair Value, Inputs, Level 2 [Member] | US Government Agencies Debt Securities [Member] | ||
Government securities | ||
Fair Value, Inputs, Level 2 [Member] | ||
Total | ||
Forward foreign currency contracts | 98 | 537 |
Total | 98 | 537 |
Fair Value, Inputs, Level 3 [Member] | Cash Equivalents [Member] | ||
Cash equivalents | ||
Fair Value, Inputs, Level 3 [Member] | US Government Agencies Debt Securities [Member] | ||
Government securities | ||
Fair Value, Inputs, Level 3 [Member] | ||
Total | ||
Forward foreign currency contracts | ||
Total | ||
Cash Equivalents [Member] | ||
Cash equivalents | 18,118 | 39,233 |
US Government Agencies Debt Securities [Member] | ||
Government securities | 20,296 | 25,232 |
Total | 38,414 | 64,465 |
Forward foreign currency contracts | 98 | 537 |
Total | $ 98 | $ 537 |
Note 3 - Fair Value Measureme23
Note 3 - Fair Value Measurements - Available-for-sale Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
US Government Agencies Debt Securities [Member] | ||
Amortized Cost | $ 20,288 | $ 25,243 |
Unrealized Gains | 8 | 1 |
Unrealized Losses | (12) | |
Fair Value | 20,296 | 25,232 |
Amortized Cost | 20,288 | 25,243 |
Unrealized Gains | 8 | 1 |
Unrealized Losses | (12) | |
Fair Value | $ 20,296 | $ 25,232 |
Note 4 - Derivative Financial24
Note 4 - Derivative Financial Instruments - Outstanding Forward Foreign Currency Contracts (Details) - Not Designated as Hedging Instrument [Member] - Foreign Exchange Forward [Member] | Sep. 30, 2016USD ($) |
Notional Amount | $ 122,015 |
Number of Instruments | 1 |
Note 4 - Derivative Financial25
Note 4 - Derivative Financial Instruments - Fair Value of Derivative Instruments (Details) - Foreign Exchange Forward [Member] - Other Current Liabilities [Member] $ in Thousands | Sep. 30, 2016USD ($) |
Gross amounts of recognized liabilities | $ 98 |
Net Amount | $ 98 |
Note 5 - Commitments and Cont26
Note 5 - Commitments and Contingencies (Details Textual) SFr in Millions | 9 Months Ended | |||
Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2016CHF (SFr) | Dec. 31, 2015USD ($) | |
Inventories [Member] | Accrued Expenses [Member] | ||||
Purchase Commitment, Amount Executed | SFr | SFr 0.8 | |||
Inventories [Member] | ||||
Purchase Commitment, Amount Executed | SFr | 1.9 | |||
Acquisition of Raw Materials [Member] | Accrued Expenses [Member] | ||||
Purchase Commitment, Amount Executed | SFr | 0.2 | |||
Acquisition of Raw Materials [Member] | ||||
Purchase Commitment, Amount Executed | SFr | 1 | |||
Inventories, Four Batches [Member] | ||||
Purchase Commitment, Amount Executed | $ 7,800,000 | SFr 7.6 | ||
Letters of Credit Outstanding, Amount | $ | 14,000 | $ 14,000 | ||
Loans Pledged as Collateral | $ | 14,000 | $ 14,000 | ||
Operating Leases, Rent Expense | $ | 136,000 | $ 139,000 | ||
Security Deposit | $ | $ 14,000 |
Note 5 - Commitments and Cont27
Note 5 - Commitments and Contingencies - Future Minimum Payments for Operating Leases (Details) $ in Thousands | Sep. 30, 2016USD ($) |
2,016 | $ 42 |
2,017 | 168 |
2,018 | 84 |
Total minimum lease payments | $ 294 |
Note 6 - Stock-based Compensa28
Note 6 - Stock-based Compensation (Details Textual) - shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
The 2014 Employee Stock Purchase Plan [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 281,000 | ||
The 2014 Employee Stock Purchase Plan [Member] | |||
Common Stock, Capital Shares Reserved for Future Issuance | 296,685 | 297,359 | 140,500 |
Share-based Compensation Arrangement by Share-based Payment Award Number of Annual Additional Shares Percentage | 1.00% | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 304,991 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Shares Issued in Period | 674 | ||
Common Stock, Capital Shares Reserved for Future Issuance | 3,295,851 | 2,717,260 |
Note 6 - Stock-based Compensa29
Note 6 - Stock-based Compensation - Stock Option Activity for Employees and Non-employees (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2016 | Dec. 31, 2015 | ||
Options Outstanding, Beginning Balance (in shares) | 2,200,369 | ||
Options Outstanding, Weighted Average Exercise Price, Beginning Balance (in dollars per share) | $ 8.52 | ||
Options Outstanding, Weighted-average Remaining Contractual Term, Beginning Balance | 7 years 109 days | 7 years 292 days | |
Options Outstanding, Aggregate Intrinsic Value, Beginning Balance | $ 15,705 | ||
Options Granted (in shares) | 119,162 | ||
Options Granted, Weighted Average Exercise Price (in dollars per share) | $ 6.90 | ||
Options Exercised (in shares) | (80,825) | ||
Options Exercised, Weighted Average Exercise Price (in dollars per share) | $ 1.91 | ||
Options Cancelled or forfeited (in shares) | (69,089) | ||
Options Cancelled or forfeited, Weighted Average Exercise Price (in dollars per share) | $ 14.12 | ||
Options Outstanding, Ending Balance (in shares) | 2,169,617 | 2,200,369 | |
Options Outstanding, Weighted Average Exercise Price, Ending Balance (in dollars per share) | $ 8.50 | $ 8.52 | |
Options Outstanding, Aggregate Intrinsic Value, Ending Balance | $ 5,814 | $ 15,705 | |
Options Exercisable (in shares) | 1,055,385 | ||
Options Exercisable, Weighted Average Exercise Price (in dollars per share) | $ 5.81 | ||
Options Exercisable, Weighted-average Remaining Contractual Term | 5 years 292 days | ||
Options Exercisable, Aggregate Intrinsic Value | $ 4,619 | ||
Options Vested or Expected to Vest (in shares) | [1] | 2,033,481 | |
Options Vested or Expected to Vest, Weighted Average Exercise Price (in dollars per share) | [1] | $ 8.29 | |
Options Vested or Expected to Vest, Weighted-average Remaining Contractual Term | [1] | 7 years 73 days | |
Options Vested or Expected to Vest, Aggregate Intrinsic Value | [1] | $ 5,697 | |
[1] | Represents the number of vested options at September 30, 2016 plus the number of unvested options expected to vest based on the unvested options outstanding at September 30, 2016. |
Note 6 - Stock-based Compensa30
Note 6 - Stock-based Compensation - Common Stock Reserved for Future Issuance (Details) - shares | Sep. 30, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Performance Shares [Member] | |||
Reserved for future issuance (in shares) | 2,999,166 | 2,419,901 | |
The 2014 Employee Stock Purchase Plan [Member] | |||
Reserved for future issuance (in shares) | 296,685 | 297,359 | 140,500 |
Reserved for future issuance (in shares) | 3,295,851 | 2,717,260 |
Note 7 - Income Taxes (Details
Note 7 - Income Taxes (Details Textual) - USD ($) | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Income Tax Expense (Benefit) | $ 0 | $ 0 |
Note 8 - Net Loss Per Share A32
Note 8 - Net Loss Per Share Attributable to Common Stockholders - Common Stock Equivalents Excluded from Calculation of Net Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Employee Stock Option [Member] | ||||
Antidilutive Securities (in shares) | 2,169,617 | 1,800,262 | 2,169,617 | 1,800,262 |
Outstanding ESPP Shares [Member] | ||||
Antidilutive Securities (in shares) | 10,913 | 1,097 | 10,913 | 1,097 |
Antidilutive Securities (in shares) | 2,180,530 | 1,801,359 | 2,180,530 | 1,801,359 |