Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 11, 2020 | |
Document Information [Line Items] | ||
Entity Registrant Name | XBiotech Inc. | |
Entity Central Index Key | 0001626878 | |
Trading Symbol | xbit | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Interactive Data Current | Yes | |
Entity Common Stock, Shares Outstanding (in shares) | 28,852,927 | |
Entity Shell Company | false | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Title of 12(b) Security | Common Stock, no par value |
Consolidated Balance Sheets (Cu
Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 241,540 | $ 714,594 |
Accounts receivable | 9,681 | |
Deferred cost of goods sold | 1,703 | |
Income tax receivable | 3,793 | |
Prepaid expenses and other current assets | 1,179 | 1,669 |
Total current assets | 257,896 | 716,263 |
Property and equipment, net | 25,034 | 25,171 |
Escrow receivable | 75,000 | 75,000 |
Deferred tax asset | 443 | 443 |
Total assets | 358,373 | 816,877 |
Current liabilities: | ||
Accounts payable | 5,649 | 2,149 |
Accrued expenses | 1,371 | 4,180 |
Contract Liabilities | 4,500 | |
Deferred revenue | 1,500 | |
Income taxes payable | 1,715 | 49,361 |
Total current liabilities | 10,235 | 60,190 |
Long-term liabilities: | ||
Deferred rent | ||
Income tax payable - non-current | 1,056 | 1,056 |
Total liabilities | 11,291 | 61,246 |
Shareholders’ equity: | ||
Preferred stock, no par value, unlimited shares authorized, no shares outstanding | 0 | 0 |
Common stock, no par value, unlimited shares authorized, 28,852,927 and 41,519,633 shares outstanding at March 31, 2020 and December 31, 2019, respectively | 242,942 | 324,808 |
Accumulated other comprehensive loss | (16) | (106) |
Retained earnings | 104,156 | 430,929 |
Total shareholders’ equity | 347,082 | 755,631 |
Total liabilities and shareholders’ equity | $ 358,373 | $ 816,877 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares $ / shares in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Preferred stock, no par value (in dollars per share) | $ 0 | $ 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Preferred stock, shares authorized | Unlimited | Unlimited |
Common stock, no par value (in dollars per share) | $ 0 | $ 0 |
Common stock, shares authorized | Unlimited | Unlimited |
Common stock, shares outstanding (in shares) | 28,852,927 | 41,519,633 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenue | $ 12,681 | $ 0 |
Cost of goods sold | 9,674 | |
Gross margin | 3,007 | |
Operating expenses: | ||
Research and development | 1,155 | 4,527 |
General and administrative | 4,023 | 1,278 |
Total operating expenses | 5,178 | 5,805 |
Loss from operations | (2,171) | (5,805) |
Other income (loss): | ||
Interest income | 1,898 | 78 |
Other income | 9 | |
Foreign exchange loss | (93) | (146) |
Total other income (loss) | 1,805 | (59) |
Loss before income taxes | (366) | (5,864) |
Provision for income taxes | 352 | 0 |
Net loss | $ (14) | $ (5,864) |
Net loss per share—basic and diluted (in dollars per share) | $ 0 | $ (0.16) |
Weighted-average number of common shares—basic and diluted (in shares) | 36,169,493 | 35,977,422 |
Manufacturing Revenue [Member] | ||
Revenue | $ 3,000 | |
Cost of goods sold | 2,166 | |
Clinical Trial Service Revenue [Member] | ||
Revenue | 9,681 | |
Cost of goods sold | $ 7,508 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Net loss | $ (14) | $ (5,864) |
Foreign currency translation adjustment | 90 | 138 |
Comprehensive loss | $ (76) | $ (5,726) |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($) $ in Thousands | Common Stock Including Additional Paid in Capital [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2018 | 35,900,000 | |||
Balance at Dec. 31, 2018 | $ 279,353 | $ (255) | $ (237,700) | $ 41,398 |
Net loss | (5,864) | (5,864) | ||
Foreign currency translation adjustment | 138 | 138 | ||
Issuance of common stock under stock option plan (in shares) | 190,000 | |||
Issuance of common stock under stock option plan | $ 643 | 643 | ||
Share-based compensation expense | 570 | 570 | ||
Stock subscription receivable | (102) | (102) | ||
Collection of stock subscription receivable | $ 200 | 200 | ||
Balance (in shares) at Mar. 31, 2019 | 36,090,000 | |||
Balance at Mar. 31, 2019 | $ 280,664 | (117) | (243,564) | 36,983 |
Balance (in shares) at Dec. 31, 2019 | 41,519 | |||
Balance at Dec. 31, 2019 | $ 324,808 | (106) | 430,929 | 755,631 |
Net loss | (14) | (14) | ||
Tender offer buyback (in shares) | (14,000) | |||
Tender offer buyback | $ (93,240) | (326,760) | (420,000) | |
Foreign currency translation adjustment | 90 | 90 | ||
Issuance of common stock under stock option plan (in shares) | 1,334 | |||
Issuance of common stock under stock option plan | $ 7,918 | 7,918 | ||
Share-based compensation expense | $ 3,456 | 3,456 | ||
Balance (in shares) at Mar. 31, 2020 | 28,853 | |||
Balance at Mar. 31, 2020 | $ 242,942 | $ (16) | $ 104,155 | $ 347,082 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating activities | ||
Net loss | $ (14) | $ (5,864) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 558 | 602 |
Share-based compensation expense | 3,456 | 570 |
Account receivable | (9,681) | |
Deferred cost of goods sold | (1,703) | |
Income tax receivable | (3,793) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 489 | 230 |
Accounts payable | 3,470 | 99 |
Accrued expenses | (2,815) | (311) |
Deferred revenue | (3,000) | |
Deferred rent | (3) | |
Tax payable | (47,640) | |
Net cash used in operating activities | (60,673) | (4,677) |
Investing activities | ||
Purchase of property and equipment | (389) | (6) |
Net cash used in investing activities | (389) | (6) |
Financing activities | ||
Share repurchases of common stock and warrants, net | (420,000) | 541 |
Issuance of common stock under stock option plan | 7,918 | 200 |
Net cash provided by (used in) financing activities | (412,082) | 741 |
Effect of foreign exchange rate on cash and cash equivalents | 90 | 138 |
Net change in cash and cash equivalents | (473,054) | (3,804) |
Cash and cash equivalents, beginning of period | 714,594 | 15,823 |
Cash and cash equivalents, end of period | 241,540 | 12,019 |
Supplemental Information: | ||
Accrued purchases of property and equipment | 32 | 109 |
Subscription receivable | $ 102 |
Note 1 - Organization
Note 1 - Organization | 3 Months Ended |
Mar. 31, 2020 | |
Notes to Financial Statements | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | 1. Organization XBiotech Inc. (XBiotech or the Company) was incorporated in Canada on March 22, 2005. November 2007. August 2010. March 2013. January 2014. Since its inception, XBiotech has focused on advancing technology to rapidly identify and clone antibodies from individuals that have resistance to disease. At the heart of the Company is a proprietary technical knowhow to translate natural human immunity into therapeutic product candidates. In 2005, With the manufacturing capability to produce its True Human ™ 2010, first 2 The Company continues to be subject to a number of risks common to companies in similar stages of development. Principal among these risks are the uncertainties of technological innovations, dependence on key individuals, development of the same or similar technological innovations by the Company’s competitors and protection of proprietary technology. All of these risks are likely to be exacerbated by the outbreak of the novel strain of coronavirus, SARS-CoV- 2 19” December 30, 2020, $241.5 March 31, 2020, one |
Note 2 - Significant Accounting
Note 2 - Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2020 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 2. Significant Accounting Policies Basis of Presentation These consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“US GAAP”). In the opinion of management, the accompanying consolidated financial statements reflect all adjustments (consisting only of normal recurring items) considered necessary to present fairly the Company’s financial position at March 31, 2020 December 31, 2019, three March 31, 2020 2019, three March 31, 2020 2019. Basis of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions have been eliminated upon consolidation. Use of Estimates The preparation of financial statements in accordance with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the reported values of amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. Revenue Revenue from Janssen Agreements The Company recognizes revenues from its Janssen Agreements as follows. The Company entered into its clinical manufacturing and clinical trial services arrangements in connection with its sale of certain intellectual property on December 30, 2019. January 1, 2020. not XBiotech is still in the research and development phase; however, the eventual output of the Company’s intended ordinary activities will be the licensing of intellectual property and/or sale of commercialized compounds for use in pharmaceutical treatment of disease, not not not 606, Revenue from Contracts with Customers 606” Under ASC 606, 606 five five 606, Manufacturing Revenue We have a Clinical Manufacturing Agreement that we account for by analogy to ASC 606, $4.5 two may 60 two four 60 may not We received payment of $4.5 December 30, 2019 first 2020. March $1.5 not . We received the syringe shipment in April, third 2020; Clinical Trial Service Revenue On December 30, 2019, two may may thirty We have determined that XBiotech is a principal with regard to the single performance obligation for the series of clinical trial services. In consideration for all of the services to be provided, for each calendar quarter during the term of the Transition Services Agreement, Janssen pays the Company for all third third 30%, March 31, 2020, $7.5 $9.7 Our clinical trial services were unaffected by the coronavirus pandemic during the first 2020. third first may not Research and Development Costs All research and development costs are charged to expense as incurred. Research and development costs include salaries and personnel-related costs, consulting fees, fees paid for contract clinical trial research services, the costs of laboratory consumables, equipment and facilities, license fees and other external costs. Costs incurred to acquire licenses for intellectual property to be used in research and development activities with no Share-Based Compensation The Company accounts for its share-based compensation awards in accordance with ASC Topic 718, Compensation-Stock Compensation 718” 718 Share-based compensation expense recognized for the three March 31, 2020 2019 Three Months Ended March 31, 2020 2019 Research and development $ 533 $ 295 General and administrative 2,144 275 Total share-based compensation expense 779 - Research and development $ 3,456 $ 570 The fair value of each option is estimated on the date of grant using the Black-Scholes method with the following assumptions: Three Months Ended March 31, 2020 2019 Dividend yield - - Expected volatility 88% - 91% 80% - 82% Risk-free interest rate 0.5% - 1.87% 2.46% - 2.64% Expected life (in years) 6.25 - 10 5.75 - 10 Weighted-average grant date fair value per share $12.08 $3.92 Cash and Cash Equivalents The Company considers highly liquid investments with a maturity of three Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents. The Company holds these investments in highly-rated financial institutions, and limits the amounts of credit exposure to any one may not not no Fair Value Measurements The consolidated financial statements include financial instruments for which the fair market value of such instruments may The Company follows ASC Topic 820, Fair Value Measurements and Disclosures three • Level 1—Unadjusted • Level 2—Quoted not • Level 3—Unobservable At March 31, 2020 December 31, 2019, not March 31, 2020 December 31, 2019, Property and Equipment Property and equipment, which consists of land, construction in process, furniture and fixtures, computers and office equipment, scientific equipment, leasehold improvements, vehicles and building are stated at cost and depreciated over the estimated useful lives of the assets, with the exception of land and construction in process which are not • Furniture and fixtures 7 • Office equipment 5 • Leasehold improvements Shorter of asset’s useful life or remaining lease term • Scientific equipment 5 • Vehicles 5 • Mobile facility 27.5 • Building 39 Costs of major additions and betterments are capitalized; maintenance and repairs, which do not Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment may not not March 31, 2020. Income Taxes Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes 740” not not The Company makes estimates and judgments in determining the need for a valuation allowance, including the estimation of its taxable income or loss for the quarter ended March 31, 2020. may not may ASC 740 may not Foreign Currency Transactions Certain transactions are denominated in a currency other than the Company’s functional currency of the U.S. dollar, and the Company generates assets and liabilities that are fixed in terms of the amount of foreign currency that will be received or paid. At each balance sheet date, the Company adjusts the assets and liabilities to reflect the current exchange rate, resulting in a translation gain or loss. Transaction gains and losses are also realized upon a settlement of a foreign currency transaction in determining net loss for the period in which the transaction is settled. Comprehensive Income (Loss) ASC Topic 220, Comprehensive Income Segment and Geographic Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company and the chief operating decision maker view the Company’s operations and manage its business as one Net Loss Per Share Net income/loss per share (“EPS”) is computed by dividing net loss by the weighted average number of common shares outstanding during each period. Diluted EPS is computed by dividing net income/loss by the weighted average number of common shares and common share equivalents outstanding (if dilutive) during each period. The number of common share equivalents, which include stock options, is computed using the treasury stock method. Subsequent Events The Company considered events or transactions occurring after the balance sheet date but prior to the date the consolidated financial statements are available to be issued for potential recognition or disclosure in its consolidated financial statements. We have evaluated subsequent events through the date of filing this Form 10 Recent Accounting Pronouncements Recently Issued Accounting Pronouncements In February 2016, 842, No. 2016 02, 840, 842 No. 201801, 842; No. 2018 10, 842, No. 201811, 842, 12 first 2019. January 1, 2019, not not In June 2016, No. 2016 13, 326 November 15, 2019, 326 December 15, 2022 not not In December 2019, 2019 12, 740 740. 740 December 15, 2020, 2019 12 March 31, 2020. 2019 12 no |
Note 3 - Revenue
Note 3 - Revenue | 3 Months Ended |
Mar. 31, 2020 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | 3. Revenue We received payment of $4.5 December 30, 2019 first 2020. March $1.5 not . We received the syringe shipment in April, third 2020; On December 30, 2019, two 30%. March 31, 2020, $7 |
Note 4 - Property and Equipment
Note 4 - Property and Equipment | 3 Months Ended |
Mar. 31, 2020 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | 4. Property and Equipment Property and equipment consisted of the following as of March 31, 2020 December 31, 2019 ( March 31, 2020 December 31, 2019 Manufacturing equipment $ 3,420 $ 3,492 Winnebago building 19,275 19,406 Other fixed assets 2,339 2,273 Total property and equipment $ 25,034 $ 25,171 |
Note 5 - Common Stock
Note 5 - Common Stock | 3 Months Ended |
Mar. 31, 2020 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 5. Common Stock Pursuant to its Articles, the Company has an unlimited number of shares available for issuance with no During June 2019, 4.8 $8.25 $37.5 $2.3 $0.2 From January December 2019, 771 $2.50 $15.00 $3.8 On January 4, 2020, $420,000,000 not not $30.00 $33.00 February 12, 2020. On February 19, 2020, 14,000,000 $0.01 $30 $420 32.67 $6.66 $93.24 $23.34 $326.76 March 31, 2020. From January March 2020, 1.3 $2.94 $19.09 $7.9 |
Note 6 - Common Stock Options
Note 6 - Common Stock Options | 3 Months Ended |
Mar. 31, 2020 | |
Notes to Financial Statements | |
Share-based Payment Arrangement [Text Block] | 6. Common Stock Options On November 11, 2005 April 1, 2015, may may All options are non-transferable and may first may The term of the options is at the discretion of the Compensation Committee, but may not 10 three The number of common shares reserved for issuance to any one 2005 may not, 5% A summary of changes in common stock options issued under the Plans is as follows: Options Exercise Price Weighted-Average Options outstanding at December 31, 2019 6,965,730 $2.71 - $21.99 6.09 Granted 50,500 8.89 - 21.8 15.40 Exercised (1,333,294 ) 2.94 - 19.09 5.94 Forfeitures (12,167 ) 4.95 - 10.36 8.13 Options outstanding at March 31, 2020 5,670,769 $2.71 - $21.99 6.17 As of March 31, 2020, $13.6 1.66 |
Note 7 - Net Income (Loss) Per
Note 7 - Net Income (Loss) Per Share | 3 Months Ended |
Mar. 31, 2020 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 7. Net Income/Loss Per Share The following summarizes the computation of basic and diluted net income/loss per share for the quarter ended March 31, 2020 2019 Three Months Ended 2020 2019 Net loss $ (14 ) $ (5,864 ) Weighted-average number of common shares—basic and diluted 36,169,493 35,977,422 Net loss per share—basic and diluted $ (0.00 ) $ (0.16 ) |
Note 8 - Income Taxes
Note 8 - Income Taxes | 3 Months Ended |
Mar. 31, 2020 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 8. Income Taxes The Company did not three March 31, 2019 no December 2019. three March 31, 2020, $352 2020 12.5% three March 31, 2020. 96.4% three March 31, 2020. The difference in the 27% not not |
Note 9 - Subsequent Events
Note 9 - Subsequent Events | 3 Months Ended |
Mar. 31, 2020 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | 9. Subsequent Events The ongoing COVID- 19 2020 may 19 not March 31, 2020, may 19 On April 3, 2020, for U.S. blood centers to begin collecting and distributing convalescent plasma from individuals who have recovered from COVID- 19. On April 14, 2020, 1 1⍺ 1⍺ 2021. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation These consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“US GAAP”). In the opinion of management, the accompanying consolidated financial statements reflect all adjustments (consisting only of normal recurring items) considered necessary to present fairly the Company’s financial position at March 31, 2020 December 31, 2019, three March 31, 2020 2019, three March 31, 2020 2019. |
Consolidation, Policy [Policy Text Block] | Basis of Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions have been eliminated upon consolidation. |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in accordance with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the reported values of amounts in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Revenue from Contract with Customer [Policy Text Block] | Revenue Revenue from Janssen Agreements The Company recognizes revenues from its Janssen Agreements as follows. The Company entered into its clinical manufacturing and clinical trial services arrangements in connection with its sale of certain intellectual property on December 30, 2019. January 1, 2020. not XBiotech is still in the research and development phase; however, the eventual output of the Company’s intended ordinary activities will be the licensing of intellectual property and/or sale of commercialized compounds for use in pharmaceutical treatment of disease, not not not 606, Revenue from Contracts with Customers 606” Under ASC 606, 606 five five 606, Manufacturing Revenue We have a Clinical Manufacturing Agreement that we account for by analogy to ASC 606, $4.5 two may 60 two four 60 may not We received payment of $4.5 December 30, 2019 first 2020. March $1.5 not . We received the syringe shipment in April, third 2020; Clinical Trial Service Revenue On December 30, 2019, two may may thirty We have determined that XBiotech is a principal with regard to the single performance obligation for the series of clinical trial services. In consideration for all of the services to be provided, for each calendar quarter during the term of the Transition Services Agreement, Janssen pays the Company for all third third 30%, March 31, 2020, $7.5 $9.7 Our clinical trial services were unaffected by the coronavirus pandemic during the first 2020. third first may not |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Costs All research and development costs are charged to expense as incurred. Research and development costs include salaries and personnel-related costs, consulting fees, fees paid for contract clinical trial research services, the costs of laboratory consumables, equipment and facilities, license fees and other external costs. Costs incurred to acquire licenses for intellectual property to be used in research and development activities with no |
Share-based Payment Arrangement [Policy Text Block] | Share-Based Compensation The Company accounts for its share-based compensation awards in accordance with ASC Topic 718, Compensation-Stock Compensation 718” 718 Share-based compensation expense recognized for the three March 31, 2020 2019 Three Months Ended March 31, 2020 2019 Research and development $ 533 $ 295 General and administrative 2,144 275 Total share-based compensation expense 779 - Research and development $ 3,456 $ 570 The fair value of each option is estimated on the date of grant using the Black-Scholes method with the following assumptions: Three Months Ended March 31, 2020 2019 Dividend yield - - Expected volatility 88% - 91% 80% - 82% Risk-free interest rate 0.5% - 1.87% 2.46% - 2.64% Expected life (in years) 6.25 - 10 5.75 - 10 Weighted-average grant date fair value per share $12.08 $3.92 |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents The Company considers highly liquid investments with a maturity of three |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentrations of Credit Risk Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents. The Company holds these investments in highly-rated financial institutions, and limits the amounts of credit exposure to any one may not not no |
Fair Value Measurement, Policy [Policy Text Block] | Fair Value Measurements The consolidated financial statements include financial instruments for which the fair market value of such instruments may The Company follows ASC Topic 820, Fair Value Measurements and Disclosures three • Level 1—Unadjusted • Level 2—Quoted not • Level 3—Unobservable At March 31, 2020 December 31, 2019, not March 31, 2020 December 31, 2019, |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment Property and equipment, which consists of land, construction in process, furniture and fixtures, computers and office equipment, scientific equipment, leasehold improvements, vehicles and building are stated at cost and depreciated over the estimated useful lives of the assets, with the exception of land and construction in process which are not • Furniture and fixtures 7 • Office equipment 5 • Leasehold improvements Shorter of asset’s useful life or remaining lease term • Scientific equipment 5 • Vehicles 5 • Mobile facility 27.5 • Building 39 Costs of major additions and betterments are capitalized; maintenance and repairs, which do not |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment may not not March 31, 2020. |
Income Tax, Policy [Policy Text Block] | Income Taxes Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes 740” not not The Company makes estimates and judgments in determining the need for a valuation allowance, including the estimation of its taxable income or loss for the quarter ended March 31, 2020. may not may ASC 740 may not |
Foreign Currency Transactions and Translations Policy [Policy Text Block] | Foreign Currency Transactions Certain transactions are denominated in a currency other than the Company’s functional currency of the U.S. dollar, and the Company generates assets and liabilities that are fixed in terms of the amount of foreign currency that will be received or paid. At each balance sheet date, the Company adjusts the assets and liabilities to reflect the current exchange rate, resulting in a translation gain or loss. Transaction gains and losses are also realized upon a settlement of a foreign currency transaction in determining net loss for the period in which the transaction is settled. |
Comprehensive Income, Policy [Policy Text Block] | Comprehensive Income (Loss) ASC Topic 220, Comprehensive Income |
Segment Reporting, Policy [Policy Text Block] | Segment and Geographic Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions on how to allocate resources and assess performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company and the chief operating decision maker view the Company’s operations and manage its business as one |
Earnings Per Share, Policy [Policy Text Block] | Net Loss Per Share Net income/loss per share (“EPS”) is computed by dividing net loss by the weighted average number of common shares outstanding during each period. Diluted EPS is computed by dividing net income/loss by the weighted average number of common shares and common share equivalents outstanding (if dilutive) during each period. The number of common share equivalents, which include stock options, is computed using the treasury stock method. |
Subsequent Events, Policy [Policy Text Block] | Subsequent Events The Company considered events or transactions occurring after the balance sheet date but prior to the date the consolidated financial statements are available to be issued for potential recognition or disclosure in its consolidated financial statements. We have evaluated subsequent events through the date of filing this Form 10 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements Recently Issued Accounting Pronouncements In February 2016, 842, No. 2016 02, 840, 842 No. 201801, 842; No. 2018 10, 842, No. 201811, 842, 12 first 2019. January 1, 2019, not not In June 2016, No. 2016 13, 326 November 15, 2019, 326 December 15, 2022 not not In December 2019, 2019 12, 740 740. 740 December 15, 2020, 2019 12 March 31, 2020. 2019 12 no |
Note 2 - Significant Accounti_2
Note 2 - Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Notes Tables | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended March 31, 2020 2019 Research and development $ 533 $ 295 General and administrative 2,144 275 Total share-based compensation expense 779 - Research and development $ 3,456 $ 570 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Three Months Ended March 31, 2020 2019 Dividend yield - - Expected volatility 88% - 91% 80% - 82% Risk-free interest rate 0.5% - 1.87% 2.46% - 2.64% Expected life (in years) 6.25 - 10 5.75 - 10 Weighted-average grant date fair value per share $12.08 $3.92 |
Note 4 - Property and Equipme_2
Note 4 - Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | March 31, 2020 December 31, 2019 Manufacturing equipment $ 3,420 $ 3,492 Winnebago building 19,275 19,406 Other fixed assets 2,339 2,273 Total property and equipment $ 25,034 $ 25,171 |
Note 6 - Common Stock Options (
Note 6 - Common Stock Options (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Notes Tables | |
Share-based Payment Arrangement, Option, Activity [Table Text Block] | Options Exercise Price Weighted-Average Options outstanding at December 31, 2019 6,965,730 $2.71 - $21.99 6.09 Granted 50,500 8.89 - 21.8 15.40 Exercised (1,333,294 ) 2.94 - 19.09 5.94 Forfeitures (12,167 ) 4.95 - 10.36 8.13 Options outstanding at March 31, 2020 5,670,769 $2.71 - $21.99 6.17 |
Note 7 - Net Income (Loss) Pe_2
Note 7 - Net Income (Loss) Per Share (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Three Months Ended 2020 2019 Net loss $ (14 ) $ (5,864 ) Weighted-average number of common shares—basic and diluted 36,169,493 35,977,422 Net loss per share—basic and diluted $ (0.00 ) $ (0.16 ) |
Note 1 - Organization (Details
Note 1 - Organization (Details Textual) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 |
Cash and Cash Equivalents, at Carrying Value, Ending Balance | $ 241,540 | $ 714,594 | $ 12,019 | $ 15,823 |
Note 2 - Significant Accounti_3
Note 2 - Significant Accounting Policies (Details Textual) $ in Thousands | Dec. 30, 2019USD ($) | Mar. 31, 2020USD ($) | Mar. 31, 2019USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) |
Cost of Goods and Services Sold, Total | $ 9,674 | ||||||
Revenue from Contract with Customer, Including Assessed Tax | 12,681 | 0 | |||||
Impairment of Long-Lived Assets Held-for-use | $ 0 | ||||||
Number of Operating Segments | 1 | ||||||
Cumulative Effect of New Accounting Principle in Period of Adoption | $ 347,082 | 36,983 | $ 347,082 | $ 755,631 | $ 41,398 | ||
Retained Earnings [Member] | |||||||
Cumulative Effect of New Accounting Principle in Period of Adoption | 104,155 | (243,564) | $ 104,155 | 430,929 | $ (237,700) | ||
Accounting Standards Update 2016-02 [Member] | Cumulative Effect, Period of Adoption, Adjustment [Member] | Retained Earnings [Member] | |||||||
Cumulative Effect of New Accounting Principle in Period of Adoption | $ 0 | ||||||
Furniture and Fixtures [Member] | |||||||
Property, Plant and Equipment, Useful Life (Year) | 7 years | ||||||
Office Equipment [Member] | |||||||
Property, Plant and Equipment, Useful Life (Year) | 5 years | ||||||
Equipment [Member] | |||||||
Property, Plant and Equipment, Useful Life (Year) | 5 years | ||||||
Vehicles [Member] | |||||||
Property, Plant and Equipment, Useful Life (Year) | 5 years | ||||||
Mobile Facility [Member] | |||||||
Property, Plant and Equipment, Useful Life (Year) | 27 years 182 days | ||||||
Building [Member] | |||||||
Property, Plant and Equipment, Useful Life (Year) | 39 years | ||||||
Fair Value, Recurring [Member] | |||||||
Assets, Fair Value Disclosure | 0 | $ 0 | 0 | ||||
Financial and Nonfinancial Liabilities, Fair Value Disclosure | 0 | 0 | $ 0 | ||||
Manufacturing Revenue [Member] | |||||||
Cost of Goods and Services Sold, Total | 2,166 | ||||||
Revenue from Contract with Customer, Including Assessed Tax | 3,000 | ||||||
Clinical Trial Service Revenue [Member] | |||||||
Cost of Goods and Services Sold, Total | 7,508 | ||||||
Revenue from Contract with Customer, Including Assessed Tax | 9,681 | ||||||
Janssen [Member] | Manufacturing Revenue [Member] | |||||||
Clinical Manufacturing Agreement, Quarterly Payments to Be Received | 4,500 | ||||||
Proceeds from Customers | $ 4,500 | ||||||
Contract with Customer, Liability, Total | $ 1,500 | $ 1,500 | |||||
Janssen [Member] | Clinical Trial Service Revenue [Member] | |||||||
Transition Services Agreement, Number of Ongoing Clinical Trials Entered Into | 2 | ||||||
Transition Services Agreement, Markup Percentage | 30.00% | 30.00% | |||||
Janssen [Member] | Clinical Trial Service Revenue [Member] | Minimum [Member] | |||||||
Cost of Goods and Services Sold, Total | $ 7,500 | ||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 9,700 |
Note 2 - Significant Accounti_4
Note 2 - Significant Accounting Policies - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based compensation expense | $ 779 | |
Share-based compensation expense | 3,456 | 570 |
Research and Development Expense [Member] | ||
Share-based compensation expense | 533 | 295 |
General and Administrative Expense [Member] | ||
Share-based compensation expense | $ 2,144 | $ 275 |
Note 2 - Significant Accounti_5
Note 2 - Significant Accounting Policies - Stock Option Valuation Assumptions (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Dividend yield | ||
Weighted-average grant date fair value per share (in dollars per share) | $ 12.08 | $ 3.92 |
Minimum [Member] | ||
Expected volatility | 88.00% | 80.00% |
Risk-free interest rate | 0.50% | 2.46% |
Expected life (Year) | 6 years 91 days | 5 years 273 days |
Maximum [Member] | ||
Expected volatility | 91.00% | 82.00% |
Risk-free interest rate | 1.87% | 2.64% |
Expected life (Year) | 10 years | 10 years |
Note 3 - Revenue (Details Textu
Note 3 - Revenue (Details Textual) $ in Thousands | Dec. 30, 2019USD ($) | Mar. 31, 2020USD ($) | Mar. 31, 2019USD ($) |
Cost of Goods and Services Sold, Total | $ 9,674 | ||
Manufacturing Revenue [Member] | |||
Cost of Goods and Services Sold, Total | 2,166 | ||
Clinical Trial Service Revenue [Member] | |||
Cost of Goods and Services Sold, Total | 7,508 | ||
Janssen [Member] | Manufacturing Revenue [Member] | |||
Proceeds from Customers | $ 4,500 | ||
Contract with Customer, Liability, Total | $ 1,500 | ||
Janssen [Member] | Clinical Trial Service Revenue [Member] | |||
Transition Services Agreement, Number of Ongoing Clinical Trials Entered Into | 2 | ||
Transition Services Agreement, Markup Percentage | 30.00% | ||
Janssen [Member] | Clinical Trial Service Revenue [Member] | Minimum [Member] | |||
Cost of Goods and Services Sold, Total | $ 7,500 |
Note 4 - Property and Equipme_3
Note 4 - Property and Equipment - Property and Equipment, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment, Net | $ 25,034 | $ 25,171 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment, Net | 3,420 | 3,492 |
Winnebago Building [Member] | ||
Property, Plant and Equipment, Net | 19,275 | 19,406 |
Property, Plant and Equipment, Other Types [Member] | ||
Property, Plant and Equipment, Net | $ 2,339 | $ 2,273 |
Note 5 - Common Stock (Details
Note 5 - Common Stock (Details Textual) - USD ($) | Feb. 19, 2020 | Jun. 30, 2019 | Mar. 31, 2020 | Dec. 31, 2019 | Jan. 04, 2020 |
Common Stock, No Par Value (in dollars per share) | $ 0 | $ 0 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares) | 1,333,294 | 771,000 | |||
Proceeds from Issuance of Common Stock | $ 7,900,000 | $ 3,800,000 | |||
Stock Repurchase Program, Authorized Amount | $ 420,000,000 | ||||
Stock Repurchased During Period, Shares (in shares) | 14,000,000 | ||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.01 | ||||
Stock Repurchased During Period, Price Per Share (in dollars per share) | $ 30 | ||||
Stock Repurchased During Period, Value | $ 420,000,000 | ||||
Percentage of Outstanding Shares Repurchased | 32.67% | ||||
Stock Issued During Period, Value, Tender Off Payback | (420,000,000) | ||||
Common Stock [Member] | |||||
Stock Repurchased During Period, Price Per Share (in dollars per share) | $ 6.66 | ||||
Stock Issued During Period, Value, Tender Off Payback | $ 93,240,000 | ||||
Retained Earnings [Member] | |||||
Stock Repurchased During Period, Price Per Share (in dollars per share) | $ 23.34 | ||||
Stock Issued During Period, Value, Tender Off Payback | $ (326,760,000) | $ (326,760,000) | |||
Minimum [Member] | |||||
Shares Issued, Price Per Share (in dollars per share) | $ 2.94 | $ 2.50 | |||
Stock Repurchase Program, Purchase Price Per Share (in dollars per share) | $ 30 | ||||
Maximum [Member] | |||||
Shares Issued, Price Per Share (in dollars per share) | $ 19.09 | $ 15 | |||
Stock Repurchase Program, Purchase Price Per Share (in dollars per share) | $ 33 | ||||
Equity Distribution Agreement [Member] | |||||
Stock Issued During Period, Shares, New Issues (in shares) | 4,800,000 | ||||
Shares Issued, Price Per Share (in dollars per share) | $ 8.25 | ||||
Proceeds from Issuance of Common Stock, Net | $ 37,500,000 | ||||
Underwriter's Commission Attributable to Issuance of Common Stock | 2,300,000 | ||||
Other Related Fee Attributable to Issuance of Common Stock | $ 200,000 |
Note 6 - Common Stock Options_2
Note 6 - Common Stock Options (Details Textual) $ in Millions | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ 13.6 |
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 240 days |
The Plan [Member] | Any One Person [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Percentage of Outstanding Stock Maximum | 5.00% |
The Plan [Member] | Share-based Payment Arrangement, Option [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year) | 10 years |
Note 6 - Common Stock Options -
Note 6 - Common Stock Options - Changes in Common Stock Options Issued (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Options outstanding (in shares) | 6,965,730 | |
Granted (in shares) | 50,500 | |
Exercised (in shares) | (1,333,294) | (771,000) |
Forfeitures (in shares) | (12,167) | |
Options outstanding (in shares) | 5,670,769 | 6,965,730 |
Minimum [Member] | ||
Options outstanding, exercise price (in dollars per share) | $ 2.71 | |
Granted, exercise price (in dollars per share) | 8.89 | |
Exercised, exercise price (in dollars per share) | 2.94 | |
Forfeitures, exercise price (in dollars per share) | 4.95 | |
Options outstanding, exercise price (in dollars per share) | 2.71 | $ 2.71 |
Maximum [Member] | ||
Options outstanding, exercise price (in dollars per share) | 21.99 | |
Granted, exercise price (in dollars per share) | 21.80 | |
Exercised, exercise price (in dollars per share) | 19.09 | |
Forfeitures, exercise price (in dollars per share) | 10.36 | |
Options outstanding, exercise price (in dollars per share) | 21.99 | 21.99 |
Weighted Average [Member] | ||
Options outstanding, exercise price (in dollars per share) | 6.09 | |
Granted, exercise price (in dollars per share) | 15.40 | |
Exercised, exercise price (in dollars per share) | 5.94 | |
Forfeitures, exercise price (in dollars per share) | 8.13 | |
Options outstanding, exercise price (in dollars per share) | $ 6.17 | $ 6.09 |
Note 7 - Net Income (Loss) Pe_3
Note 7 - Net Income (Loss) Per Share - Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Net loss | $ (14) | $ (5,864) |
Weighted-average number of common shares—basic and diluted (in shares) | 36,169,493 | 35,977,422 |
Net loss per share—basic and diluted (in dollars per share) | $ 0 | $ (0.16) |
Note 8 - Income Taxes (Details
Note 8 - Income Taxes (Details Textual) - USD ($) $ in Thousands | Jan. 01, 2020 | Mar. 31, 2020 | Mar. 31, 2019 |
Income Tax Expense (Benefit), Total | $ (352) | $ 0 | |
Revenue from Contract with Customer, Including Assessed Tax | $ 12,681 | $ 0 | |
Effective Income Tax Rate Reconciliation, Percent, Total | 12.50% | ||
Domestic Tax Authority [Member] | Canada Revenue Agency [Member] | |||
Effective Income Tax Rate Reconciliation, Foreign Income Tax Rate Differential, Percent | 27.00% |