Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2016 | May. 05, 2016 | |
Document and Entity Information | ||
Entity Registrant Name | Theravance Biopharma, Inc. | |
Entity Central Index Key | 1,583,107 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 47,479,910 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q1 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 128,803 | $ 112,707 |
Short-term marketable securities | 51,073 | 59,727 |
Accounts receivable, net of allowances of $894 and $758 at March 31, 2016 and December 31, 2015, respectively | 1,527 | 1,922 |
Receivables from collaborative arrangements | 37,536 | 35,232 |
Prepaid taxes | 242 | 12,764 |
Other prepaid and current assets | 10,165 | 5,115 |
Inventories | 9,406 | 10,005 |
Total current assets | 238,752 | 237,472 |
Property and equipment, net | 10,119 | 9,873 |
Long-term marketable securities | 34,598 | 42,860 |
Other investments | 8,000 | 8,000 |
Restricted cash | 833 | 833 |
Other assets | 823 | 1,078 |
Total assets | 293,125 | 300,116 |
Current liabilities: | ||
Accounts payable | 9,092 | 18,804 |
Accrued personnel-related expenses | 7,824 | 10,866 |
Accrued clinical and development expenses | 23,640 | 14,709 |
Other accrued liabilities | 4,725 | 4,947 |
Deferred revenue | 1,120 | 144 |
Total current liabilities | 46,401 | 49,470 |
Deferred rent | 4,449 | 4,598 |
Other long-term liabilities | $ 3,738 | $ 2,983 |
Commitments and contingencies (Note 9) | ||
Shareholders' equity | ||
Preferred shares, $0.00001 par value: 230 shares authorized, no shares issued or outstanding at March 31, 2016 and December 31, 2015, respectively | ||
Ordinary shares, $0.00001 par value: 200,000 shares authorized at March 31, 2016 and December 31, 2015; 41,452 and 37,981 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively | ||
Additional paid-in capital | $ 602,117 | $ 564,691 |
Accumulated other comprehensive income (loss) | 126 | (70) |
Accumulated deficit | (363,706) | (321,556) |
Total shareholders' equity | 238,537 | 243,065 |
Total liabilities and shareholders' equity | $ 293,125 | $ 300,116 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) shares in Thousands, $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Account receivable, allowance | $ 894 | $ 758 |
Preferred shares, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Preferred shares, shares authorized | 230 | 230 |
Preferred shares, shares issued | 0 | 0 |
Preferred shares, outstanding shares | 0 | 0 |
Ordinary shares, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
Ordinary shares, authorized shares | 200,000 | 200,000 |
Ordinary shares, shares issued | 41,452 | 37,981 |
Ordinary shares, outstanding shares | 41,452 | 37,981 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Revenue: | ||
Product sales | $ 3,311 | $ 1,280 |
Revenue from collaborative arrangements | 15,099 | 19,121 |
Total revenue | 18,410 | 20,401 |
Costs and expenses: | ||
Cost of goods sold | 778 | 371 |
Research and development | 35,678 | 36,019 |
Selling, general and administrative | 23,596 | 21,748 |
Total costs and expenses | 60,052 | 58,138 |
Loss from operations | (41,642) | (37,737) |
Interest and other income | 186 | 211 |
Loss before income taxes | (41,456) | (37,526) |
Provision for income taxes | 694 | 4,948 |
Net loss | (42,150) | (42,474) |
Share-based compensation expense | $ 11,330 | $ 15,626 |
Net loss per share: | ||
Basic and diluted net loss per share (in dollars per share) | $ (1.10) | $ (1.29) |
Shares used to compute basic and diluted net loss per share (in shares) | 38,326 | 32,830 |
Net unrealized gain on available-for-sale investments | $ 196 | $ 113 |
Total comprehensive loss | (41,954) | (42,361) |
Research and development | ||
Costs and expenses: | ||
Share-based compensation expense | 5,160 | 7,482 |
Selling, general and administrative | ||
Costs and expenses: | ||
Share-based compensation expense | $ 6,170 | $ 8,144 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Operating activities | ||
Net loss | $ (42,150) | $ (42,474) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 699 | 825 |
Share-based compensation | 11,330 | 15,626 |
Inventory write-down | 10 | 79 |
Excess tax benefits from share-based compensation | 0 | (391) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 395 | (276) |
Receivables from collaborative arrangements | (2,304) | (17,820) |
Prepaid taxes | 12,522 | (10) |
Other prepaid and current assets | (5,050) | (664) |
Inventories | 134 | (41) |
Other assets | 255 | (180) |
Accounts payable | (9,450) | (5,431) |
Accrued personnel-related expenses, accrued clinical and development expenses, and other accrued liabilities | 5,718 | (6,184) |
Deferred rent | (149) | (106) |
Deferred revenue | 1,141 | 212 |
Other long-term liabilities | 590 | 321 |
Net cash used in operating activities | (26,309) | (56,514) |
Investing activities | ||
Purchases of property and equipment | (684) | (657) |
Purchases of marketable securities | 0 | (10,659) |
Maturities of marketable securities | 17,069 | 53,470 |
Net cash provided by investing activities | 16,385 | 42,154 |
Financing activities | ||
Net proceeds from sale of ordinary shares | 27,802 | 25,753 |
Excess tax benefits from share-based compensation | 0 | 391 |
Repurchase of shares to satisfy tax withholding | (1,782) | (100) |
Net cash provided by financing activities | 26,020 | 26,044 |
Net increase in cash and cash equivalents | 16,096 | 11,684 |
Cash and cash equivalents at beginning of period | 112,707 | 89,215 |
Cash and cash equivalents at end of period | 128,803 | 100,899 |
Supplemental disclosure of cash flow information | ||
Cash paid for income taxes, net | $ 9,494 | $ 765 |
Description of Operations and S
Description of Operations and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2016 | |
Description of Operations and Summary of Significant Accounting Policies | |
Description of Operations and Summary of Significant Accounting Policies | 1. Description of Operations and Summary of Significant Accounting Policies Description of Operations Theravance Biopharma, Inc. (“Theravance Biopharma”, the “Company”, or “we” and other similar pronouns) is a diversified biopharmaceutical company with the core purpose of creating medicines that make a difference in the lives of patients suffering from serious illness. Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV ® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. Revefenacin (TD-4208) is a long-acting muscarinic antagonist (“LAMA”) being developed as a potential once-daily, nebulized treatment for chronic obstructive pulmonary disease (“COPD”). Our neprilysin (“NEP”) inhibitor program is designed to develop selective NEP inhibitors for the treatment of a range of major cardiovascular and renal diseases, including acute and chronic heart failure, hypertension and chronic kidney diseases such as diabetic nephropathy. Our research efforts are focused in the areas of inflammation and immunology, with the goal of designing medicines that provide targeted drug delivery to tissues in the lung and gastrointestinal tract in order to maximize patient benefit and minimize risk. The first program to emerge from this research is designed to develop GI-targeted pan-Janus kinases (“JAK”) inhibitors for the treatment of a range of inflammatory intestinal diseases. In addition, we have an economic interest in future payments that may be made by Glaxo Group Limited or one of its affiliates (“GSK”) pursuant to its agreements with Innoviva, Inc. (“Innoviva”) (known as Theravance, Inc. prior to January 7, 2016) relating to certain drug development programs, including the Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol), currently in development for the treatment of COPD and asthma. Basis of Presentation The Company’s condensed consolidated financial information as of March 31, 2016, and the three months ended March 31, 2016 and 2015 are unaudited but include all adjustments (consisting only of normal recurring adjustments), which we consider necessary for a fair presentation of the financial position at such date and of the operating results and cash flows for those periods, and have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated December 31, 2015 financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (“SEC”) on March 11, 2016. Significant Accounting Policies There have been no material revisions in our significant accounting policies described in Note 1 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2015. Recently Issued Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (“ASU 2016-02”) . ASU 2016-02 is aimed at making leasing activities more transparent and comparable, and requires substantially all leases be recognized by lessees on their balance sheet as a right-of-use asset and corresponding lease liability, including leases currently accounted for as operating leases. ASU 2016-02 is effective for all interim and annual reporting periods beginning after December 15, 2018 with early adoption permitted. We are currently evaluating the impact that the adoption of ASU 2016-02 will have on our consolidated financial statements and related disclosures. In March 2016, the FASB issued Accounting Standards Update No. 2016-08, Revenue from Contracts with Customers (Topic 606) (“ASU 2016-08”) which clarifies whether an entity is a principal or an agent in a transaction in which another party in involved in providing goods or services to a customer. ASU 2016-08 also clarifies (i) how an entity should identify the unit of accounting for the principal versus agent evaluation and (ii) how the control principle applies to transactions, and reframes the indicators to focus on evidence that an entity is acting as a principal rather than as an agent. ASU 2016-08 is effective for all interim and annual reporting periods beginning after December 15, 2017, and early adoption is permitted for interim and annual reporting periods beginning after December 15, 2016. We are currently evaluating the impact that the adoption of ASU 2016-08 will have on our consolidated financial statements and related disclosures. In March 2016, the FASB also issued Accounting Standards Update No. 2016-09, Compensation — Stock Compensation (Topic 718) (“ASU 2016-09”). ASU 2016-09 simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as equity or liabilities, an option to recognize gross share compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows. ASU 2016-09 is effective for all interim and annual reporting periods beginning after December 15, 2016 with early adoption permitted. We are currently evaluating the potential impact that the adoption of ASU 2016-09 will have on our consolidated financial statements and related disclosures. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2016 | |
Net Loss per Share | |
Net Loss per Share | 2. Net Loss per Share Basic net loss per share is computed by dividing net loss by the weighted-average number of shares outstanding, less ordinary shares subject to forfeiture. Diluted net loss per share is computed by dividing net loss by the weighted-average number of shares outstanding, less ordinary shares subject to forfeiture, plus all additional ordinary shares that would have been outstanding, assuming dilutive potential common shares had been issued for other dilutive securities. For the three months ended March 31, 2016 and 2015, diluted and basic net loss per share was identical since potential common shares were excluded from the calculation, as their effect was anti-dilutive. Anti-Dilutive Securities The following common equivalent shares were not included in the computation of diluted net loss per share because their effect was anti-dilutive: Three Months Ended March 31, (In thousands) 2016 2015 Share issuances under equity incentive plan and ESPP Restricted shares |
Collaborative Arrangements
Collaborative Arrangements | 3 Months Ended |
Mar. 31, 2016 | |
Collaborative Arrangements | |
Collaborative Arrangements | 3. Collaborative Arrangements Revenue from Collaborative Arrangements We recognized the following revenues from our collaborative arrangements: Three Months Ended March 31, (In thousands) 2016 2015 Mylan $ $ Other Total revenue from collaborative arrangements $ $ Mylan Development and Commercialization Agreement In January 2015, we established a strategic collaboration with Mylan Ireland Limited (“Mylan”) for the development and, subject to regulatory approval, commercialization of revefenacin (TD-4208), our investigational LAMA in development for the treatment of COPD. We entered into this collaboration to expand the breadth of our revefenacin development program and extend our commercial reach beyond the acute care setting where we currently market VIBATIV. In the first quarter of 2015, upfront payments totaling $19.2 million from Mylan were allocated to the license and committee participation deliverables based on the relative selling price method. The $19.2 million consisted of the initial payment of $15.0 million in cash and the $4.2 million premium related to the equity investment, which represents the difference between the closing price on January 30, 2015 and the issued price of $18.918 per share. For the three months ended March 31, 2015, we recognized $19.1 million in revenue from the Mylan collaborative arrangement related primarily to the license and technological know-how delivered in the first quarter of 2015. For the three months ended March 31, 2016, we recognized $15.0 million in revenue from the Mylan collaborative arrangement for the achievement of 50% enrollment in the Phase 3 twelve-month safety study, which triggered a milestone payment to Theravance Biopharma by Mylan. Reimbursement of R&D Costs Under certain collaborative arrangements, we are entitled to reimbursement of certain R&D costs. Our policy is to account for the reimbursement payments by our collaboration partners as reductions to R&D expense. The following table summarizes the reductions to R&D expenses related to the reimbursement payments: Three Months Ended March 31, (In thousands) 2016 2015 Mylan $ $ Alfa Wassermann R-Pharm — Total reduction to R&D costs $ $ |
Available-for-Sale Securities a
Available-for-Sale Securities and Fair Value Measurements | 3 Months Ended |
Mar. 31, 2016 | |
Available-for-Sale Securities and Fair Value Measurements. | |
Available-for-Sale Securities and Fair Value Measurements | 4. Available-for-Sale Securities and Fair Value Measurements Our available-for-sale securities include: Fair Value Hierarchy Estimated Fair Value (In thousands) Level March 31, 2016 December 31, 2015 U.S. government securities Level 1 $ $ U.S. government agency securities Level 2 Corporate notes Level 2 Commerial paper Level 2 Marketable securities Money market funds Level 1 Total $ $ The estimated fair value of marketable securities is based on quoted market prices for these or similar investments that were based on prices obtained from a commercial pricing service. The fair value of our marketable securities classified within Level 2 is based upon observable inputs that may include benchmark yields, reported trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers and reference data including market research publications. Gross unrealized gains and losses were not significant at either March 31, 2016 or December 31, 2015. At March 31, 2016, all of the marketable securities had contractual maturities within two years and the weighted average maturity of the marketable securities was approximately nine months. There were no transfers between Level 1 and Level 2 during the periods presented and there have been no changes to our valuation techniques during the three months ended March 31, 2016. We do not intend to sell the investments that are in an unrealized loss position, and it is unlikely that we will be required to sell the investments before recovery of their amortized cost basis, which may be maturity. We have determined that the gross unrealized losses on our marketable securities at March 31, 2016 were temporary in nature. All marketable securities with unrealized losses at March 31, 2016 have been in a loss position for less than twelve months. At March 31, 2016, our accumulated other comprehensive income (loss) on our condensed consolidated balance sheets consisted of net unrealized gains on available-for-sale investments. During the three months ended March 31, 2016, we did not sell any of our marketable securities. Restricted cash pertained to certain lease agreements and letters of credit where we have pledged cash and cash equivalents as collateral. |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2016 | |
Inventories | |
Inventories | 5. Inventories Inventory consists of the following: (In thousands) March 31, 2016 December 31, 2015 Raw materials $ $ Work-in-process — Finished goods Total inventories $ $ |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2016 | |
Share-Based Compensation. | |
Share-Based Compensation | 6. Share-Based Compensation Share-Based Compensation Expense Allocation The allocation of share-based compensation expense included in the condensed consolidated statements of operations was as follows: Three Months Ended March 31, (In thousands) 2016 2015 Research and development $ $ Selling, general and administrative Total share-based compensation expense $ $ Total share-based compensation expense capitalized to inventory was not material for any of the periods presented. Performance-Contingent Awards In the first quarter of 2016, the Compensation Committee of the Company’s Board of Directors approved the grant of 1,575,000 performance-contingent restricted stock awards (RSAs) and 135,000 performance-contingent restricted share units (RSUs) to senior management. These grants have dual triggers of vesting based upon the achievement of certain performance conditions over a five-year timeframe from 2016 to 2020 and continued employment, both of which must be satisfied in order for the awards to vest. Expense associated with these awards would be recognized during the years 2016 to 2020 depending on the probability of meeting the performance conditions. The maximum potential expense associated with the awards could be up to approximately $26.7 million (allocated as $11.4 million for research and development expense and $15.3 million for selling, general and administrative expense) if all of the performance conditions are achieved on time. Compensation expense relating to awards subject to performance conditions is recognized if it is considered probable that the performance goals will be achieved. The probability of achievement will be reassessed each reporting period. As of March 31, 2016, we determined that the achievement of the requisite performance conditions was not probable and, as a result, no compensation expense related to these awards has been recognized. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2016 | |
Income Taxes | |
Income Taxes | 7. Income Taxes The income tax provision was $0.7 million for the three months ended March 31, 2016. The provision for income tax was primarily due to uncertain tax positions taken with respect to transfer pricing and tax credits. No provision for income taxes has been recognized on undistributed earnings of our foreign subsidiaries because we consider such earnings to be indefinitely reinvested. We follow the accounting guidance related to accounting for income taxes which requires that a company reduce its deferred tax assets by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some portion or all of its deferred tax assets will not be realized. At March 31, 2016, our deferred tax assets were offset in full by a valuation allowance. We record liabilities related to uncertain tax positions in accordance with the income tax guidance which clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Resolution of one or more of these uncertain tax positions in any period may have a material impact on the results of operations for that period. We include any applicable interest and penalties within the provision for income taxes in the condensed consolidated statements of operations. The difference between the Irish statutory rate and our effective tax rate is primarily due to the valuation allowance on deferred tax assets and the liabilities recorded for the uncertain tax position related to transfer pricing and tax credits. Our future income tax expense may be affected by such factors as changes in tax laws, our business, regulations, tax rates, interpretation of existing laws or regulations, the impact of accounting for share-based compensation, the impact of accounting for business combinations, our international organization, shifts in the amount of income before tax earned in the U.S. as compared with other regions in the world, and changes in overall levels of income before tax. |
Shareholders' Equity
Shareholders' Equity | 3 Months Ended |
Mar. 31, 2016 | |
Stockholders' Equity | |
Shareholders' Equity | 8. Shareholders’ Equity Purchases of Ordinary Shares by GSK On March 17, 2016, GSK purchased 1,301,015 of our unregistered ordinary shares at a per share price of $17.70 pursuant to an Ordinary Share Purchase Agreement between the Company and GSK, dated as of March 14, 2016. The aggregate gross proceeds of the purchase were approximately $23.0 million. As of March 31, 2016, GSK beneficially owned approximately 23.3% of our outstanding ordinary shares. Ordinary Shares Issuance under At-the-Market Agreement Pursuant to a sales agreement with Cantor Fitzgerald & Co. (“Cantor Fitzgerald”), we may issue and sell up to $50 million of our ordinary shares pursuant to an at-the-market offering program (“ATM Agreement”), under our shelf registration statement on Form S-3 effective in July 2015. Under the ATM Agreement, we pay Cantor Fitzgerald a commission rate of up to 3.0% of the gross proceeds from the sale of our ordinary shares. We engaged in sales of our ordinary shares under the ATM Agreement from March 17, 2016 to April 8, 2016. During this period, we sold approximately 770,000 shares at an average price of $19.53 per share, resulting in aggregate net proceeds of approximately $14.6 million. For the three months ended March 31, 2016, we sold approximately 280,000 shares at an average price of $18.48 per share, resulting in aggregate net proceeds of approximately $5.0 million. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2016 | |
Commitments and Contingencies | |
Commitments and Contingencies | 9. Commitments and Contingencies Guarantees and Indemnifications We indemnify our officers and directors for certain events or occurrences, subject to certain limits. We believe the fair value of these indemnification agreements is minimal. Accordingly, we have not recognized any liabilities relating to these agreements as of March 31, 2016. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2016 | |
Subsequent Events | |
Subsequent Events | 10. Subsequent Events Public Offering of Ordinary Shares On May 4, 2016, we closed the sale of an aggregate of 5,479,750 of our ordinary shares, $0.00001 par value, at a public offering price of $21.00 per share. The shares were issued pursuant to a prospectus supplement filed with the SEC on April 28, 2016, in connection with a takedown from our shelf registration statement on Form S-3. We received net offering proceeds of approximately $107.7 million after deducting the underwriting discount and estimated offering expenses. |
Description of Operations and16
Description of Operations and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2016 | |
Description of Operations and Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The Company’s condensed consolidated financial information as of March 31, 2016, and the three months ended March 31, 2016 and 2015 are unaudited but include all adjustments (consisting only of normal recurring adjustments), which we consider necessary for a fair presentation of the financial position at such date and of the operating results and cash flows for those periods, and have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated December 31, 2015 financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission (“SEC”) on March 11, 2016. |
Significant Accounting Policies | Significant Accounting Policies There have been no material revisions in our significant accounting policies described in Note 1 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2015. |
Recently Issued Accounting Pronouncements Not Yet Adopted | Recently Issued Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (“ASU 2016-02”) . ASU 2016-02 is aimed at making leasing activities more transparent and comparable, and requires substantially all leases be recognized by lessees on their balance sheet as a right-of-use asset and corresponding lease liability, including leases currently accounted for as operating leases. ASU 2016-02 is effective for all interim and annual reporting periods beginning after December 15, 2018 with early adoption permitted. We are currently evaluating the impact that the adoption of ASU 2016-02 will have on our consolidated financial statements and related disclosures. In March 2016, the FASB issued Accounting Standards Update No. 2016-08, Revenue from Contracts with Customers (Topic 606) (“ASU 2016-08”) which clarifies whether an entity is a principal or an agent in a transaction in which another party in involved in providing goods or services to a customer. ASU 2016-08 also clarifies (i) how an entity should identify the unit of accounting for the principal versus agent evaluation and (ii) how the control principle applies to transactions, and reframes the indicators to focus on evidence that an entity is acting as a principal rather than as an agent. ASU 2016-08 is effective for all interim and annual reporting periods beginning after December 15, 2017, and early adoption is permitted for interim and annual reporting periods beginning after December 15, 2016. We are currently evaluating the impact that the adoption of ASU 2016-08 will have on our consolidated financial statements and related disclosures. In March 2016, the FASB also issued Accounting Standards Update No. 2016-09, Compensation — Stock Compensation (Topic 718) (“ASU 2016-09”). ASU 2016-09 simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as equity or liabilities, an option to recognize gross share compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows. ASU 2016-09 is effective for all interim and annual reporting periods beginning after December 15, 2016 with early adoption permitted. We are currently evaluating the potential impact that the adoption of ASU 2016-09 will have on our consolidated financial statements and related disclosures. |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Net Loss per Share | |
Schedule of anti-dilutive securities | Three Months Ended March 31, (In thousands) 2016 2015 Share issuances under equity incentive plan and ESPP Restricted shares |
Collaborative Arrangements (Tab
Collaborative Arrangements (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Collaborative Arrangements | |
Schedule of revenue recognized from collaborative arrangements | Three Months Ended March 31, (In thousands) 2016 2015 Mylan $ $ Other Total revenue from collaborative arrangements $ $ |
Summary of reductions to R&D costs related to the reimbursement payments | Three Months Ended March 31, (In thousands) 2016 2015 Mylan $ $ Alfa Wassermann R-Pharm — Total reduction to R&D costs $ $ |
Available-for-Sale Securities19
Available-for-Sale Securities and Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Available-for-Sale Securities and Fair Value Measurements. | |
Schedule of available-for-sale securities | Fair Value Hierarchy Estimated Fair Value (In thousands) Level March 31, 2016 December 31, 2015 U.S. government securities Level 1 $ $ U.S. government agency securities Level 2 Corporate notes Level 2 Commerial paper Level 2 Marketable securities Money market funds Level 1 Total $ $ |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Inventories | |
Schedule of inventories | (In thousands) March 31, 2016 December 31, 2015 Raw materials $ $ Work-in-process — Finished goods Total inventories $ $ |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Share-Based Compensation. | |
Schedule of share-based compensation expense included in the condensed consolidated statements of operations | Three Months Ended March 31, (In thousands) 2016 2015 Research and development $ $ Selling, general and administrative Total share-based compensation expense $ $ |
Net Loss per Share (Details)
Net Loss per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Anti-Dilutive Securities | ||
Shares not included in the computation of diluted net loss per share (in shares) | 5,633 | 4,748 |
Share issuances under equity incentive plan and ESPP | ||
Anti-Dilutive Securities | ||
Shares not included in the computation of diluted net loss per share (in shares) | 4,136 | 4,353 |
RSAs | ||
Anti-Dilutive Securities | ||
Shares not included in the computation of diluted net loss per share (in shares) | 1,497 | 395 |
Collaborative Arrangements (Det
Collaborative Arrangements (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Collaborative Arrangements | ||
Total revenue from collaborative arrangements | $ 15,099 | $ 19,121 |
Mylan | ||
Collaborative Arrangements | ||
Total revenue from collaborative arrangements | 15,025 | 19,099 |
Other | ||
Collaborative Arrangements | ||
Total revenue from collaborative arrangements | $ 74 | $ 22 |
Collaborative Arrangements (D24
Collaborative Arrangements (Details 2) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||
Mar. 31, 2016 | Mar. 31, 2015 | Feb. 28, 2015 | |
Collaborative Arrangements | |||
Revenue from collaborative arrangements | $ 15,099 | $ 19,121 | |
Mylan | |||
Collaborative Arrangements | |||
Revenue from collaborative arrangements | $ 15,025 | 19,099 | |
Achievement in enrollment (as a percent) | 50.00% | ||
Mylan | Purchase Agreement | |||
Collaborative Arrangements | |||
Share Price | $ 18.918 | ||
Premium proceeds from sale of ordinary shares | 4,200 | ||
Mylan | Development and Commercialization Agreement | |||
Collaborative Arrangements | |||
Initial cash payment | 15,000 | ||
Payments received | $ 19,200 |
Collaborative Arrangements (D25
Collaborative Arrangements (Details 3) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Total reduction to R&D costs | $ 32,372 | $ 4,554 |
Mylan | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Total reduction to R&D costs | 31,173 | 4,132 |
Alfa Wassermann | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Total reduction to R&D costs | 1,185 | 422 |
R-Pharm | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Total reduction to R&D costs | $ 14 | $ 0 |
Available-for-Sale Securities26
Available-for-Sale Securities and Fair Value Measurements (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Dec. 31, 2015 | |
Marketable securities | ||
Marketable securities | $ 85,671 | $ 102,587 |
Total | $ 161,185 | 171,713 |
Maturity period for marketable securities | ||
Maximum contractual maturity period | 2 years | |
Weighted average contractual maturity period | 9 months | |
Fair value transfers | ||
Fair value of assets transferred from Level 1 to Level 2 | $ 0 | |
Fair value of assets transferred from Level 2 to Level 1 | 0 | |
Fair value of liabilities transferred from Level1 to Level2 | 0 | |
Fair value of liabilities transferred from Level 2 to Level 1 | 0 | |
Level 1 | ||
Marketable securities | ||
Money market funds | 75,514 | 69,126 |
U.S. government securities | Level 1 | ||
Marketable securities | ||
Marketable securities | 42,150 | 47,043 |
U.S. government agencies securities | Level 2 | ||
Marketable securities | ||
Marketable securities | 26,014 | 31,465 |
Corporate notes | Level 2 | ||
Marketable securities | ||
Marketable securities | 12,511 | 19,089 |
Commercial paper | Level 2 | ||
Marketable securities | ||
Marketable securities | $ 4,996 | $ 4,990 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Inventories | ||
Raw materials | $ 5,270 | $ 6,869 |
Work-in-process | 1,758 | 0 |
Finished goods | 2,378 | 3,136 |
Total inventories | $ 9,406 | $ 10,005 |
Share-Based Compensation (Detai
Share-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Share-Based Compensation | ||
Share-based compensation expense | $ 11,330 | $ 15,626 |
Research and development | ||
Share-Based Compensation | ||
Share-based compensation expense | 5,160 | 7,482 |
Selling, general and administrative | ||
Share-Based Compensation | ||
Share-based compensation expense | 6,170 | $ 8,144 |
Performance-Contingent | Senior management | ||
Share-Based Compensation | ||
Share-based compensation expense | $ 0 | |
Vesting period | 5 years | |
Performance-Contingent | Senior management | Potential planned | Research and development | ||
Share-Based Compensation | ||
Share-based compensation expense | $ 11,400 | |
Performance-Contingent | Senior management | Potential planned | Selling, general and administrative | ||
Share-Based Compensation | ||
Share-based compensation expense | $ 15,300 | |
RSAs | Performance-Contingent | Senior management | ||
Share-Based Compensation | ||
Shares approved for grant (in shares) | 1,575,000 | |
RSUs | Performance-Contingent | Senior management | ||
Share-Based Compensation | ||
Shares approved for grant (in shares) | 135,000 | |
Maximum | Performance-Contingent | Senior management | Potential planned | ||
Share-Based Compensation | ||
Share-based compensation expense | $ 26,700 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Income Taxes | ||
Provision for income taxes | $ 694 | $ 4,948 |
Provision for income taxes on undistributed earnings | $ 0 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Mar. 17, 2016 | Apr. 08, 2016 | Jul. 31, 2015 | Mar. 31, 2016 | Mar. 31, 2015 |
Shareholders' Equity | |||||
Net proceeds from sale of ordinary shares | $ 27,802 | $ 25,753 | |||
At-the-Market Agreement | |||||
Shareholders' Equity | |||||
Sale of ordinary shares (in shares) | 770,000 | 280,000 | |||
Net proceeds from sale of ordinary shares | $ 14,600 | $ 5,000 | |||
At-the-Market Agreement | Average | |||||
Shareholders' Equity | |||||
Share price (in dollars per share) | $ 19.53 | $ 18.48 | |||
GSK | |||||
Shareholders' Equity | |||||
Ownership percentage | 23.30% | ||||
GSK | Purchase Agreement | |||||
Shareholders' Equity | |||||
Sale of ordinary shares (in shares) | 1,301,015 | ||||
Share price (in dollars per share) | $ 17.70 | ||||
Aggregate gross proceeds of share purchase | $ 23,000 | ||||
Cantor Fitzgerald & Co | At-the-Market Agreement | Maximum | |||||
Shareholders' Equity | |||||
Net proceeds from sale of ordinary shares | $ 50,000 | ||||
Sales agent and underwriter commission rate (as a percent) | 3.00% |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Thousands | May. 04, 2016 | Mar. 31, 2016 | Mar. 31, 2015 | Dec. 31, 2015 |
Subsequent Events | ||||
Ordinary shares, par value (in dollars per share) | $ 0.00001 | $ 0.00001 | ||
Net proceeds from sale of ordinary shares | $ 27,802 | $ 25,753 | ||
Subsequent Events | Prospectus supplement filed with SEC on April 28, 2016 | ||||
Subsequent Events | ||||
Sale of ordinary shares (in shares) | 5,479,750 | |||
Ordinary shares, par value (in dollars per share) | $ 0.00001 | |||
Share price (in dollars per share) | $ 21 | |||
Net proceeds from sale of ordinary shares | $ 107,700 |