x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Ireland | 98-1111119 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification Number) |
Adelphi Plaza Upper George's Street Dún Laoghaire Co. Dublin, A96 T927, Ireland |
(Address of principal executive offices including Zip Code) |
Large accelerated filer | x | Accelerated filer | o |
Non-accelerated filer | o(Do not check if a smaller reporting company) | Smaller reporting company | o |
Emerging growth company | o | ||
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. o |
Page | |
Condensed Consolidated Balance Sheets as of June 30, 2017 and December 31, 2016 | |
Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2017 and 2016 | |
Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2017 and 2016 | |
June 30, | December 31, | ||||||
2017 | 2016 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 471,729 | $ | 386,923 | |||
Receivable from Roche | 30,240 | 178 | |||||
Prepaid expenses and other current assets | 9,751 | 4,261 | |||||
Total current assets | 511,720 | 391,362 | |||||
Non-current assets: | |||||||
Property and equipment, net | 55,843 | 56,452 | |||||
Deferred tax assets | 5,756 | 5,913 | |||||
Restricted cash | 4,056 | 4,056 | |||||
Other non-current assets | 1,625 | 2,193 | |||||
Total non-current assets | 67,280 | 68,614 | |||||
Total assets | $ | 579,000 | $ | 459,976 | |||
Liabilities and Shareholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 12,545 | $ | 13,069 | |||
Accrued research and development | 20,799 | 19,073 | |||||
Income taxes payable, current | 404 | 378 | |||||
Other current liabilities | 5,851 | 8,555 | |||||
Total current liabilities | 39,599 | 41,075 | |||||
Non-current liabilities: | |||||||
Income taxes payable, non-current | — | 98 | |||||
Deferred rent | 277 | 2,080 | |||||
Build-to-suit lease obligation, non-current | 52,148 | 51,320 | |||||
Total non-current liabilities | 52,425 | 53,498 | |||||
Total liabilities | 92,024 | 94,573 | |||||
Commitments and contingencies (Note 7) | |||||||
Shareholders’ equity: | |||||||
Euro deferred shares, €22 nominal value: | — | — | |||||
Authorized shares — 10,000 at June 30, 2017 and December 31, 2016 | |||||||
Issued and outstanding shares — none at June 30, 2017 and December 31, 2016 | |||||||
Ordinary shares, $0.01 par value: | 382 | 348 | |||||
Authorized shares — 100,000,000 at June 30, 2017 and December 31, 2016 | |||||||
Issued and outstanding shares — 38,156,959 and 34,752,116 at June 30, 2017 and December 31, 2016, respectively | |||||||
Additional paid-in capital | 828,792 | 654,266 | |||||
Accumulated deficit | (342,198 | ) | (289,211 | ) | |||
Total shareholders’ equity | 486,976 | 365,403 | |||||
Total liabilities and shareholders’ equity | $ | 579,000 | $ | 459,976 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Collaboration revenue | $ | 26,812 | $ | 333 | $ | 27,071 | $ | 598 | ||||||||
Total revenue | 26,812 | 333 | 27,071 | 598 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 34,032 | 32,359 | 59,730 | 52,852 | ||||||||||||
General and administrative | 10,912 | 8,134 | 21,744 | 15,316 | ||||||||||||
Total operating expenses | 44,944 | 40,493 | 81,474 | 68,168 | ||||||||||||
Loss from operations | (18,132 | ) | (40,160 | ) | (54,403 | ) | (67,570 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income (expense), net | 18 | (10 | ) | (346 | ) | 267 | ||||||||||
Other expense, net | (874 | ) | (86 | ) | (1,284 | ) | (293 | ) | ||||||||
Total other expense, net | (856 | ) | (96 | ) | (1,630 | ) | (26 | ) | ||||||||
Loss before income taxes | (18,988 | ) | (40,256 | ) | (56,033 | ) | (67,596 | ) | ||||||||
Provision for (benefit from) income taxes | (1,287 | ) | 189 | (2,948 | ) | 370 | ||||||||||
Net loss | $ | (17,701 | ) | $ | (40,445 | ) | $ | (53,085 | ) | $ | (67,966 | ) | ||||
Basic and diluted net loss per share | $ | (0.46 | ) | $ | (1.18 | ) | $ | (1.44 | ) | $ | (1.99 | ) | ||||
Shares used to compute basic and diluted net loss per share | 38,073 | 34,358 | 36,922 | 34,192 |
Six Months Ended June 30, | |||||||
2017 | 2016 | ||||||
Operating activities | |||||||
Net loss | $ | (53,085 | ) | $ | (67,966 | ) | |
Adjustments to reconcile net loss to cash used in operating activities: | |||||||
Depreciation and amortization | 1,518 | 679 | |||||
Share-based compensation | 12,255 | 8,270 | |||||
Deferred income taxes | 157 | (854 | ) | ||||
Interest expense under build-to-suit lease obligation | 1,830 | 325 | |||||
Gain from early lease retirement | (2,096 | ) | — | ||||
Gain from disposal of fixed assets | (5 | ) | — | ||||
Changes in operating assets and liabilities: | |||||||
Receivable from Roche | (30,062 | ) | 145 | ||||
Prepaid and other assets | (8,744 | ) | (2,331 | ) | |||
Accounts payable, accruals and other liabilities | 4,311 | 9,349 | |||||
Net cash used in operating activities | (73,921 | ) | (52,383 | ) | |||
Investing activities | |||||||
Purchases of property and equipment | (2,712 | ) | (942 | ) | |||
Proceeds from disposal of fixed assets | 105 | — | |||||
Net cash used in investing activities | (2,607 | ) | (942 | ) | |||
Financing activities | |||||||
Proceeds from issuance of ordinary shares in public offering, net | 150,323 | 128,777 | |||||
Proceeds from issuance of ordinary shares upon exercise of stock options | 12,013 | 966 | |||||
Reduction of build-to-suit lease obligation | (1,002 | ) | — | ||||
Net cash provided by financing activities | 161,334 | 129,743 | |||||
Net increase in cash, cash equivalents and restricted cash | 84,806 | 76,418 | |||||
Cash, cash equivalents and restricted cash, beginning of the year | 390,979 | 370,586 | |||||
Cash, cash equivalents and restricted cash, end of the period | $ | 475,785 | $ | 447,004 | |||
Supplemental disclosures of cash flow information | |||||||
Cash paid for income taxes, net of refunds | $ | 691 | $ | 877 | |||
Supplemental disclosures of non-cash investing and financing activities | |||||||
Acquisition of property and equipment included in accounts payable and accrued liabilities | $ | 393 | $ | 16 | |||
Offering costs included in accounts payable and accrued liabilities | $ | 31 | $ | — | |||
Stock option shortfall | $ | — | $ | (11 | ) | ||
Amounts capitalized under build-to-suit lease transaction | $ | — | $ | 37,571 | |||
Interest capitalized during construction period for build-to-suit lease transaction | $ | — | $ | 326 |
1. | Organization |
2. | Summary of Significant Accounting Policies |
3. | Fair Value Measurements |
Level 2 — | Include other inputs that are based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model-based valuation techniques for which all significant inputs are observable in the market or can be derived from observable market data. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs including interest rate curves, foreign exchange rates, and credit ratings. |
Level 3 — | Unobservable inputs that are supported by little or no market activities, which would require the Company to develop its own assumptions. |
4. | Composition of Certain Balance Sheet Items |
June 30, 2017 | December 31, 2016 | ||||||
Machinery and equipment | $ | 9,020 | $ | 9,629 | |||
Leasehold improvements | 580 | 2,769 | |||||
Purchased computer software | 714 | 363 | |||||
Build-to-suit property | 51,760 | 51,359 | |||||
62,074 | 64,120 | ||||||
Less: accumulated depreciation and amortization | (6,231 | ) | (7,668 | ) | |||
Property and equipment, net | $ | 55,843 | $ | 56,452 |
June 30, 2017 | December 31, 2016 | ||||||
Payroll and related expenses | $ | 4,234 | $ | 6,629 | |||
Professional services | 351 | 435 | |||||
Deferred rent | 49 | 363 | |||||
Other | 1,217 | 1,128 | |||||
Other current liabilities | $ | 5,851 | $ | 8,555 |
5. | Net Income (loss) Per Ordinary Share |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Numerator: | |||||||||||||||
Net loss | $ | (17,701 | ) | $ | (40,445 | ) | $ | (53,085 | ) | $ | (67,966 | ) | |||
Denominator: | |||||||||||||||
Weighted-average ordinary shares outstanding | 38,073 | 34,358 | 36,922 | 34,192 | |||||||||||
Net loss per share: | |||||||||||||||
Basic and diluted net loss per share | $ | (0.46 | ) | $ | (1.18 | ) | $ | (1.44 | ) | $ | (1.99 | ) |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||
Stock options to purchase ordinary shares | 4,608 | 4,121 | 4,608 | 4,121 |
Year Ended December 31, | Operating Lease | |||
2017 (6 months) | $ | 118 | ||
2018 | 236 | |||
2019 | 236 | |||
2020 | 237 | |||
2021 | 237 | |||
Thereafter | 867 | |||
Total | $ | 1,931 |
Year Ended December 31, | Expected Cash Payments Under Build-To-Suit Lease Obligation | |||
2017 (6 months) | $ | 2,015 | ||
2018 | 4,915 | |||
2019 | 5,803 | |||
2020 | 5,979 | |||
2021 | 6,165 | |||
Thereafter | 12,885 | |||
Total | $ | 37,762 |
Total | 2017 | 2018 | 2019 | 2020 | 2021 | Thereafter | ||||||||||||||||||||||
Purchase Obligations | $ | 44,872 | $ | 22,271 | $ | 6,976 | $ | 15,593 | $ | 32 | $ | — | $ | — | ||||||||||||||
Contractual obligations under license agreements(1) | 1,725 | 405 | 130 | 130 | 100 | 100 | 860 | |||||||||||||||||||||
Total | $ | 46,597 | $ | 22,676 | $ | 7,106 | $ | 15,723 | $ | 132 | $ | 100 | $ | 860 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Research and development | $ | 2,735 | $ | 1,818 | $ | 5,043 | $ | 3,237 | |||||||
General and administrative | 3,918 | 2,728 | 7,212 | 5,033 | |||||||||||
Total share-based compensation expense | $ | 6,653 | $ | 4,546 | $ | 12,255 | $ | 8,270 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2017 | 2016 | 2017 | 2016 | ||||
Expected volatility | 72.2% | 75.6% | 72.8% | 74.9% | |||
Risk-free interest rate | 2.0% | 1.5% | 2.0% | 1.4% | |||
Expected dividend yield | —% | —% | —% | —% | |||
Expected life (in years) | 6.0 | 6.0 | 6.0 | 6.0 | |||
Weighted average grant date fair value | $35.37 | $28.72 | $35.32 | $23.52 |
Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (years) | Aggregate Intrinsic Value (in thousands) | |||||||||
Outstanding at December 31, 2016 | 4,064,207 | $ | 27.19 | 6.79 | $ | 92,640 | ||||||
Granted | 1,284,800 | 54.37 | ||||||||||
Exercised | (704,843 | ) | 17.04 | |||||||||
Canceled | (35,713 | ) | 43.68 | |||||||||
Outstanding at June 30, 2017 | 4,608,451 | $ | 36.20 | 7.89 | $ | 85,235 | ||||||
Vested and expected to vest at June 30, 2017 | 4,494,967 | $ | 35.87 | 7.86 | $ | 84,561 | ||||||
Vested at June 30, 2017 | 2,012,459 | $ | 22.48 | 6.48 | $ | 64,155 |
• | our ability to obtain additional financing in future offerings; |
• | our operating losses; |
• | our ability to successfully complete research and development of our drug candidates; |
• | our ability to develop, manufacture and commercialize products; |
• | our collaboration with Roche pursuant to the License Agreement; |
• | our ability to protect our patents and other intellectual property; |
• | our ability to hire and retain key employees; |
• | tax treatment of our separation from Elan and subsequent distribution of our ordinary shares; |
• | our ability to maintain financial flexibility and sufficient cash, cash equivalents, and investments and other assets capable of being monetized to meet our liquidity requirements; |
• | potential disruptions in the U.S. and global capital and credit markets; |
• | government regulation of our industry; |
• | the volatility of our ordinary share price; |
• | business disruptions; and |
• | the other risks and uncertainties described in the “Risk Factors” section of this Form 10-Q. |
Three Months Ended June 30, | Percentage Change | |||||||||
2017 | 2016 | |||||||||
(Dollars in thousands) | ||||||||||
Collaboration revenue | $ | 26,812 | $ | 333 | 7,952 | % | ||||
Total revenue | $ | 26,812 | $ | 333 | 7,952 | % |
Six Months Ended June 30, | Percentage Change | |||||||||
2017 | 2016 | |||||||||
(Dollars in thousands) | ||||||||||
Collaboration revenue | $ | 27,071 | $ | 598 | 4,427 | % | ||||
Total revenue | $ | 27,071 | $ | 598 | 4,427 | % |
Three Months Ended June 30, | Percentage Change | |||||||||
2017 | 2016 | |||||||||
(Dollars in thousands) | ||||||||||
Research and development | $ | 34,032 | $ | 32,359 | 5 | % | ||||
General and administrative | 10,912 | 8,134 | 34 | % | ||||||
Total operating expenses | $ | 44,944 | $ | 40,493 | 11 | % |
Six Months Ended June 30, | Percentage Change | |||||||||
2017 | 2016 | |||||||||
(Dollars in thousands) | ||||||||||
Research and development | $ | 59,730 | $ | 52,852 | 13 | % | ||||
General and administrative | 21,744 | 15,316 | 42 | % | ||||||
Total operating expenses | $ | 81,474 | $ | 68,168 | 20 | % |
Three Months Ended June 30, | Six Months Ended June 30, | Cumulative to Date | ||||||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||||||
NEOD001 (1) | $ | 26,226 | $ | 22,377 | $ | 44,446 | $ | 35,613 | $ | 195,162 | ||||||||||
PRX002 (2) | 218 | 1,797 | 2,196 | 3,192 | 46,532 | |||||||||||||||
PRX003 (3) | 2,555 | 2,637 | 5,170 | 5,067 | 54,610 | |||||||||||||||
Other R&D (4) | 5,033 | 5,548 | 7,918 | 8,980 | ||||||||||||||||
$ | 34,032 | $ | 32,359 | $ | 59,730 | $ | 52,852 |
(1) | Cumulative R&D costs to date for NEOD001 include the costs incurred from the date when the program has been separately tracked in nonclinical development. Expenditures in the early discovery stage are not tracked by program and accordingly have been excluded from this cumulative amount. |
(2) | Cumulative R&D costs to date for PRX002 and related antibodies include the costs incurred from the date when the program has been separately tracked in nonclinical development. Expenditures in the early discovery stage are not tracked by program and accordingly have been excluded from this cumulative amount. PRX002 cost include payments to Roche for our share of the development expenses incurred by Roche related to PRX002 programs and is net of reimbursements from Roche for development and supply services recorded as an offset to R&D expense. For the three and six months ended June 30, 2017, $3.8 million and $4.6 million, respectively, were recorded as an offset to R&D expenses including $3.4 million for a portion of the $30.0 million milestone receivable from Roche in the quarter ended June 30, 2017. For the three and six months ended June 30, 2016, $0.7 million and $1.9 million, respectively, were recorded as an offset to R&D expenses. |
(3) | Cumulative R&D costs to date for PRX003 include the costs incurred from the date when the program has been separately tracked in nonclinical development. Expenditures in the early discovery stage are not tracked by program and accordingly have been excluded from this cumulative amount. |
(4) | Other R&D is comprised of nonclinical development and discovery programs that have not progressed to first patient dosing in a Phase 1 clinical trial. |
Three Months Ended June 30, | Percentage Change | |||||||||
2017 | 2016 | |||||||||
(Dollars in thousands) | ||||||||||
Interest income | $ | 932 | $ | 314 | 197 | % | ||||
Interest expense | (914 | ) | (324 | ) | 182 | % | ||||
Interest income (expense), net | 18 | (10 | ) | (280 | )% | |||||
Other expense, net | (874 | ) | (86 | ) | 916 | % | ||||
Total Other Income (Expense) | $ | (856 | ) | $ | (96 | ) | 792 | % |
Six Months Ended June 30, | Percentage Change | |||||||||
2017 | 2016 | |||||||||
(Dollars in thousands) | ||||||||||
Interest income | $ | 1,484 | $ | 591 | 151 | % | ||||
Interest expense | (1,830 | ) | (324 | ) | 465 | % | ||||
Interest income (expense), net | (346 | ) | 267 | (230 | )% | |||||
Other expense, net | (1,284 | ) | (293 | ) | 338 | % | ||||
Total Other Income (Expense) | $ | (1,630 | ) | $ | (26 | ) | 6,169 | % |
Three Months Ended June 30, | Percentage Change | |||||||||
2017 | 2016 | |||||||||
(Dollars in thousands) | ||||||||||
Provision for (benefit from) income taxes | $ | (1,287 | ) | $ | 189 | (781 | )% |
Six Months Ended June 30, | Percentage Change | |||||||||
2017 | 2016 | |||||||||
(Dollars in thousands) | ||||||||||
Provision for (benefit from) income taxes | $ | (2,948 | ) | $ | 370 | (897 | )% |
June 30, | December 31, | ||||||
2017 | 2016 | ||||||
Working capital | $ | 472,121 | $ | 350,287 | |||
Cash and cash equivalents | 471,729 | 386,923 | |||||
Total assets | 579,000 | 459,976 | |||||
Total liabilities | 92,024 | 94,573 | |||||
Total shareholders’ equity | 486,976 | 365,403 |
Six Months Ended June 30, | |||||||
2017 | 2016 | ||||||
Net cash used in operating activities | $ | (73,921 | ) | $ | (52,383 | ) | |
Net cash used in investing activities | (2,607 | ) | (942 | ) | |||
Net cash provided by financing activities | 161,334 | 129,743 | |||||
Net increase in cash and cash equivalents and restricted cash | $ | 84,806 | $ | 76,418 |
Total | 2017 | 2018 | 2019 | 2020 | 2021 | Thereafter | ||||||||||||||||||||||
Operating leases (1) | $ | 1,931 | $ | 118 | $ | 236 | $ | 236 | $ | 237 | $ | 237 | $ | 867 | ||||||||||||||
Minimum cash payments under build-to-suit lease obligation (1) | 37,762 | 2,015 | 4,915 | 5,803 | 5,979 | 6,165 | 12,885 | |||||||||||||||||||||
Purchase obligations | 44,872 | 22,271 | 6,976 | 15,593 | 32 | — | — | |||||||||||||||||||||
Contractual obligations under license agreements (2) | 1,725 | 405 | 130 | 130 | 100 | 100 | 860 | |||||||||||||||||||||
Total | $ | 86,290 | $ | 24,809 | $ | 12,257 | $ | 21,762 | $ | 6,348 | $ | 6,502 | $ | 14,612 |
• | conduct our Phase 3, Phase 2b and open label extension ("OLE") clinical trials for NEOD001, conduct our Phase 1b clinical trial for PRX003 and initiate additional clinical trials for these and other programs; |
• | develop and commercialize our product candidates, including NEOD001, PRX002/RG7935, PRX003 and PRX004; |
• | complete nonclinical development of other product candidates and initiate clinical trials, if supported by positive nonclinical data; and |
• | pursue our early stage research and seek to identify additional drug candidates and potentially acquire rights from third parties to drug candidates through licenses, acquisitions or other means. |
• | the timing of initiation, progress, results and costs of our clinical trials, including our Phase 3, Phase 2b and OLE clinical trials for NEOD001, the Phase 2 clinical trial for PRX002/RG7935, our Phase 1b clinical trial for PRX003 and our contemplated Phase 1 clinical trial for PRX004; |
• | the timing, initiation, progress, results and costs of these and our other research, development and commercialization activities; |
• | the results of our research and nonclinical studies; |
• | the costs of clinical manufacturing and of establishing commercial manufacturing arrangements and other commercialization needs; |
• | the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; |
• | our ability to establish research collaborations, strategic collaborations, licensing or other arrangements; |
• | the costs to satisfy our obligations under potential future collaborations; and |
• | the timing, receipt, and amount of revenues or royalties, if any, from any approved drug candidates. |
• | terminate or delay clinical trials or other development for one or more of our drug candidates; |
• | delay arrangements for activities that may be necessary to commercialize our drug candidates; |
• | curtail or eliminate our drug research and development programs that are designed to identify new drug candidates; or |
• | cease operations. |
• | our historical financial information reflects allocations for services historically provided to us by Elan, which allocations may not reflect the costs we will incur for similar services in the future as an independent company; |
• | subsequent to our separation from Elan, the cost of capital for our business has been and may continue to be higher than Elan’s cost of capital prior to the separation because Elan’s cost of debt was lower than ours has been and will likely continue to be; and |
• | our historical financial information does not reflect changes that we have incurred as a result of the separation from Elan, including changes in the cost structure, personnel needs, financing and operations of the contributed business as a result of the separation from Elan and from reduced economies of scale. |
• | offer improvement over existing, comparable products; |
• | be proven safe and effective in clinical trials; or |
• | meet applicable regulatory standards. |
• | obtaining and maintaining commercial manufacturing arrangements with third-party manufacturers; |
• | collaborating with pharmaceutical companies or contract sales organizations to market and sell any approved drug; or |
• | acceptance of any approved drug in the medical community and by patients and third-party payors. |
• | conditions imposed on us by the FDA or any other regulatory authority regarding the scope or design of our clinical trials; |
• | delays in obtaining, or our inability to obtain, required approvals from institutional review boards ("IRBs") or other reviewing entities at clinical sites selected for participation in our clinical trials; |
• | insufficient supply or deficient quality of our drug candidates or other materials necessary to conduct our clinical trials; |
• | delays in obtaining regulatory agency agreement for the conduct of our clinical trials; |
• | lower than anticipated enrollment and retention rate of subjects in clinical trials for a variety of reasons, including size of patient population, nature of trial protocol, the availability of other treatments for the relevant disease and competition from other clinical trial programs for similar indications; |
• | serious and unexpected drug-related side effects experienced by subjects in clinical trials; or |
• | failure of our third-party contractors and collaborators to meet their contractual obligations to us in a timely manner. |
• | failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols; |
• | inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold; |
• | interpretation of data by the FDA or other regulatory authorities; |
• | requirement by the FDA or other regulatory authorities to perform additional studies; |
• | failure to achieve primary or secondary endpoints or other failure to demonstrate efficacy or adequate safety; |
• | unforeseen safety issues; or |
• | lack of adequate funding to continue the clinical trial. |
• | the FDA or comparable regulatory authorities may disagree with the design, implementation or conduct of our clinical trials; |
• | we may be unable to demonstrate to the satisfaction of the FDA or comparable regulatory authorities that a drug candidate is safe and effective for its proposed indication; |
• | the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable regulatory authorities for approval; |
• | we may be unable to demonstrate that a drug candidate’s clinical and other benefits outweigh its safety risks; |
• | the FDA or comparable regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical trials; |
• | the data collected from clinical trials of our drug candidates may not be sufficient to support the submission of a Biologic License Application ("BLA") or other submission or to obtain regulatory approval in the U.S., EU or elsewhere; |
• | the FDA or comparable regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; or |
• | the approval policies or regulations of the FDA or comparable regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. |
• | restrictions on the marketing of our products or their manufacturing processes; |
• | warning letters; |
• | civil or criminal penalties; |
• | fines; |
• | injunctions; |
• | product seizures or detentions; |
• | import or export bans; |
• | voluntary or mandatory product recalls and related publicity requirements; |
• | suspension or withdrawal of regulatory approvals; |
• | total or partial suspension of production; and |
• | refusal to approve pending applications for marketing approval of new products or supplements to approved applications. |
• | regulatory authorities may withdraw their approval of the product; |
• | regulatory authorities may require the addition of labeling statements, such as warnings or contraindications; |
• | we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product; |
• | we could be sued and held liable for harm caused to patients; and |
• | our reputation may suffer. |
• | the indication and label for the product and the timing of introduction of competitive products; |
• | demonstration of clinical safety and efficacy compared to other products; |
• | prevalence and severity of adverse side effects; |
• | availability of coverage and adequate reimbursement from managed care plans and other third-party payors; |
• | convenience and ease of administration; |
• | cost-effectiveness; |
• | other potential advantages of alternative treatment methods; and |
• | the effectiveness of marketing and distribution support of the product. |
• | an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs; |
• | an increase in the minimum rebates a manufacturer must pay under the U.S. Medicaid Drug Rebate Program to 23.1% and 13.0% of the average manufacturer price for branded and generic drugs, respectively; |
• | expansion of healthcare fraud and abuse laws, including the U.S. False Claims Act and the U.S. Anti-Kickback Statute, new government investigative powers and enhanced penalties for non-compliance; |
• | a new Medicare Part D coverage gap discount program, under which manufacturers must agree to offer 50 percent point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; |
• | extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; |
• | expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with |
• | a licensure framework for follow-on biologic products; |
• | expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; |
• | new requirements under the federal Open Payments program and its implementing regulations; |
• | a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and |
• | a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research. |
• | significantly greater financial, technical and human resources than we have and may be better equipped to discover, develop, manufacture and commercialize drug candidates; |
• | more extensive experience in nonclinical testing and clinical trials, obtaining regulatory approvals and manufacturing and marketing pharmaceutical products; |
• | drug candidates that have been approved or are in late-stage clinical development; and/or |
• | collaborative arrangements in our target markets with leading companies and research institutions. |
• | the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; |
• | federal civil and criminal false claims laws and civil monetary penalty laws, including the False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; |
• | the U.S. Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), which created new federal criminal statutes that impose criminal and civil liability for executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; |
• | the U.S. Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services ("CMS") information related to “payments or other transfers of value” made to physicians, which is defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by the physicians and their immediate family members. The period between August 1, 2013 and December 31, 2013 was the first reporting period, and manufacturers were required to report aggregate payment data by March 31, 2014, and were required to report detailed payment data and submit legal attestation to the accuracy of such data during Phase 2 of the program (which began in May 2014). Thereafter, manufacturers must submit reports by the 90th day of each subsequent calendar year; |
• | HIPAA, as amended by the U.S. Health Information Technology and Clinical Health Act, and its implementing regulations, which impose obligations on covered healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; and |
• | analogous state and other jurisdictions' laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and other jurisdictions' laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and other jurisdictions' laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and other jurisdictions' laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. |
• | decreased demand for any approved drug candidates; |
• | impairment of our business reputation; |
• | withdrawal of clinical trial participants; |
• | costs of related litigation; |
• | distraction of management’s attention; |
• | substantial monetary awards to patients or other claimants; and |
• | loss of revenues; and the inability to successfully commercialize any approved drug candidates. |
• | the patentability of our inventions relating to our drug candidates; and/or |
• | the enforceability, validity or scope of protection offered by our patents relating to our drug candidates. |
• | incur substantial monetary damages; |
• | encounter significant delays in bringing our drug candidates to market; and/or |
• | be precluded from participating in the manufacture, use or sale of our drug candidates or methods of treatment requiring licenses. |
• | our ability to obtain financing as needed; |
• | progress in and results from our ongoing or future clinical trials; |
• | our collaboration with Roche pursuant to the License Agreement to develop and commercialize PRX002/RG7935, as well as any future Licensed Products targeting α-synuclein; |
• | failure or delays in advancing our nonclinical drug candidates or other drug candidates we may develop in the future, into clinical trials; |
• | results of clinical trials conducted by others on drugs that would compete with our drug candidates; |
• | issues in manufacturing our drug candidates; |
• | regulatory developments or enforcement in the U.S. and other countries; |
• | developments or disputes concerning patents or other proprietary rights; |
• | introduction of technological innovations or new commercial products by our competitors; |
• | changes in estimates or recommendations by securities analysts, if any, who cover our company; |
• | public concern over our drug candidates; |
• | litigation; |
• | future sales of our ordinary shares; |
• | general market conditions; |
• | changes in the structure of healthcare payment systems; |
• | failure of any of our drug candidates, if approved, to achieve commercial success; |
• | economic and other external factors or other disasters or crises; |
• | period-to-period fluctuations in our financial results; |
• | overall fluctuations in U.S. equity markets; |
• | our quarterly or annual results, or those of other companies in our industry; |
• | announcements by us or our competitors of significant acquisitions or dispositions; |
• | the operating and ordinary share price performance of other comparable companies; |
• | investor perception of our company and the drug development industry; |
• | natural or environmental disasters that investors believe may affect us; or |
• | fluctuations in the budgets of federal, state and local governmental entities around the world. |
Dated: | August 8, 2017 | Prothena Corporation plc (Registrant) | ||
/s/ Gene G. Kinney | ||||
Gene G. Kinney | ||||
President and Chief Executive Officer | ||||
/s/ Tran B. Nguyen | ||||
Tran B. Nguyen | ||||
Chief Financial Officer |
Previously Filed | |||||||||
Exhibit No. | Description | Form | File No. | Filing Date | Exhibit | Filed Herewith | |||
10.1# | Prothena Corporation plc Amended and Restated 2012 Long Term Incentive Plan | 8-K | 001-35676 | 05/23/2017 | 10.1 | ||||
10.2# | Offer letter, dated April 2, 2017, between Prothena Biosciences Inc and Sarah B. Noonberg | X | |||||||
10.3# | Promotion letter, dated June 9, 2017, between Prothena Biosciences Inc and Wagner M. Zago | X | |||||||
10.4† | Letter Agreement, dated April 5, 2017, among Prothena Therapeutics Limited, Prothena Biosciences Limited and Boehringer Ingelheim Biopharmaceuticals GmbH | X | |||||||
31.1 | Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | X | |||||||
31.2 | Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | X | |||||||
32.1* | Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | |||||||
101.INS+ | XBRL Instance Document | X | |||||||
101.SCH+ | XBRL Taxonomy Extension Schema Document | X | |||||||
101.CAL+ | XBRL Taxonomy Extension Calculation Linkbase Document | X | |||||||
101.DEF+ | XBRL Taxonomy Extension Definition Linkbase Document | X | |||||||
101.LAB+ | XBRL Taxonomy Extension Label Linkbase Document | X | |||||||
101.PRE+ | XBRL Taxonomy Extension Presentation Linkbase Document | X |
# | Indicates management contract or compensatory plan or arrangement. |
† | Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and this exhibit has been filed separately with the SEC. |
* | Exhibit 32.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise specifically stated in such filing. |
+ | XBRL information is furnished and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934, and is not subject to liability under those sections, is not part of any registration statement or prospectus to which it relates and is not incorporated or deemed to be incorporated by reference into any registration statement, prospectus or other document. |
Sarah Noonberg [Address] | UPDATED - March 29, 2017 |
Wagner M. Zago, Ph.D. [Address] | June 9, 2017 |
1 | Definitions |
2 | Scope of the Agreement |
2.1 | As of the Effective Date the Parties agree on an overall capacity commitment for the Years 2018 to 2027 as further set forth in Section 4 and Appendix 3 below. Subject to the terms set forth in this Agreement, the overall capacity commitment shall be used for all Products manufactured by BI BIO under the Product Agreements. For clarity, the subject matter of this Agreement is the overall capacity commitment and purchase obligation of Prothena for Years 2018 through 2027 (binding from the Years 2018 to 2024). |
2.2 | The manufacture and supply of Products and the performance of services by BI BIO, or an Affiliate thereof, (the “Services”) and all rights and obligations of the Parties in connection therewith shall be governed by and be subject to the terms and provisions of the Product Agreements. In all cases where the (i) the reservation of annual overall capacity and amendment thereof (e.g. in a long range capacity plan or the like), or (ii) the undersupply of Product due to a Capacity Limitation, including but not limited to, a Capacity Limitation Threshold and the remedies available to Prothena in connection with the aforementioned cases (i) and/or (ii) are concerned, the provisions of this Agreement shall prevail over the respective provisions of the Existing Agreement and the provisions of this Agreement in the cases (i) and (ii) shall be included in the MSA. |
2.3 | BI BIO shall devote adequate manufacturing capacity at the Facilities corresponding with the Maximum Capacity Reservation to be capable of manufacturing Product(s) for Prothena and performing the work under the respective Product Agreement as set forth under Section 4 and Appendix 3. |
2.4 | Prothena shall purchase and pay the Price for Product as set forth under the respective provisions and rolling forecasts of the applicable Product Agreement, however in any event, Prothena shall pay the [***] according to Appendix 4 for a minimum of Batches according to the Minimum Purchase Commitment set forth in Section 4 below. |
2.5 | The Parties agree that they shall negotiate in good faith and agree upon a Master Technical Transfer and Supply Agreement which shall govern the technical transfer, clinical supply and/or commercial manufacture of Products for clinical and commercial use for Prothena and which shall replace the Existing Agreement and this Agreement (the “MSA”). The Parties shall execute such MSA by [***]. |
2.6 | The Parties are in agreement that the MSA, including its Product Addendums, shall set forth main provisions, including but not limited to, technology transfer, manufacture, clinical and commercial supply, that are equivalent to the main provisions of the Existing Agreement. The Parties agree to further include the pricing, capacity commitments, and all stipulations of this Agreement concerning the undersupply of Product due to a Capacity Limitation, including but not limited to, a Capacity Limitation Threshold and the remedies available to Prothena in connection therewith into the MSA. |
2.7 | Further, the MSA shall provide for the following termination rights of Prothena for the Product Addendum for each Product and the corresponding effects of termination: |
Termination Right for each Product (unless stated otherwise) | Effect of Termination for each Product (unless stated otherwise), Prothena shall pay for: |
Clinical Failure Forced Withdrawal | • For [***] from BI BIO’s receipt of Prothena’s termination notification: i) the [***] for [***] ii) the [***] for the [***] of [***] of the [***] which were [***] by [***] (if any) [***] [***] |
There was not a Clinical Failure, but there was [***] resulting in a [***] of [***] | • For [***] from BI BIO’s receipt of Prothena’s termination notification: i) the [***] for [***] ii) the [***] for the [***] of [***] of the [***] which were [***] (if any) [***] [***] |
Convenience (any reason or no reason, incl. voluntary market withdrawal) | • For [***] from BI BIO’s receipt of Prothena’s termination notification: i) the [***] for [***] ii) the [***] for the [***] of [***] of the [***] which were [***] (if any) [***] [***] |
2.8 | The MSA shall also provide that BI BIO shall undertake reasonable commercial efforts to fill any resulting excess capacity with products from third parties or its Affiliates for the manufacture of other biopharmaceutical products. For each Batch of Prothena’s capacity mitigated by BI BIO the Price for reserved Batches or the Non-Utilization-Fee, as applicable, from Prothena, shall not fall due. |
3 | PROTHENA PRODUCTS MANUFACTURED |
3.1. | As of the Effective Date the Parties agree that the Products manufactured by BI BIO during the Term include Prothena’s proprietary Products NEOD001 and PRX003, as well as New Products, Prothena desires and the Parties will mutually agree to transfer and establish at the Facilities. |
3.2. | The Parties agree that during the Term, Prothena may request to transfer in and have BI BIO manufacture up to [***] New Products. Each request shall include the complete Prothena Deliverables as set forth in Appendix 1 and shall be made by Prothena in writing at least [***] prior to the desired commencement of a technology transfer. Upon receiving such request, including the Prothena Deliverables, BI BIO shall assess the requirements for such New Product, including any technology transfer requirements and shall accept or reject the product as New Product by BI BIO in accordance with the Acceptance Criteria as set forth in Appendix 2 within [***] of receiving the request together with the complete Prothena Deliverables from Prothena. |
3.3. | BI BIO shall determine and decide which Facility shall manufacture such New Product based on the assessment of fitness of the New Product and its manufacturing process for the Existing Facility and the New Facility and BI BIO’s network capacity utilization. BI BIO shall share its assessment with Prothena and shall take into consideration Prothena’s reasonable input and recommendations. |
3.4. | Upon Prothena’s request the Parties shall negotiate in good faith and may agree upon the opportunity and terms and conditions to technology transfer and manufacture more than [***] New Products. |
4 | CAPACITY COMMITMENT FOR PRODUCTS AT THE FACILITIES |
4.1 | In accordance with their commitment set forth in Section 2, the Parties agree on the Minimum Purchase Commitment and Maximum Capacity Reservation as shown in Appendix 3. The latest by [***] Prothena may cancel or reduce its order for the Year [***] and no Non-Utilization Fee shall become due. For the purpose of clarity, Prothena shall not be entitled to submit a [***] order in any Year, including in [***]. |
4.2 | The Parties agree to hold long-range capacity review meetings at least annually to review Prothena’s demand and Minimum Purchase Commitment, and BI BIO’s Facility utilization and Maximum Capacity Reservation in order to discuss changes according to the remainder of this Section 4 below. BI BIO and Prothena each shall appoint as representatives for these meetings individuals having seniority and decision-making power. |
4.3 | (a) On or before [***], the Parties shall agree on the binding Maximum Capacity Reservation and Minimum Purchase Commitment for the Years 2025, 2026 and 2027, whereby the numbers set forth for the aforementioned Years in Appendix 3 are not binding and shall be deemed as an orientation point for good faith discussions. |
4.4 | A minimum campaign size in a Facility of [***] of (a) the lesser of the Minimum Purchase Commitment or [***] shall apply to each Product and (b) the [***] of the Minimum Purchase Commitment or [***] shall apply to each Low-Volume-Product to keep the respective production process for a Product active and maintain inspection readiness. For the purpose of clarity, Prothena is required to purchase Product in accordance with the minimum campaign sizes set forth in this Section 4.4 and Prothena shall not be entitled to submit [***] orders for a Product in any given Year. |
4.5 | Subject to Section 4.1 with respect to the Year [***], in each Year from [***] to [***] Prothena shall purchase [***] of the Minimum Purchase Commitment which equals the certain percentage of the Maximum Capacity Reservation as determined in Appendix 3. |
4.6 | Subject to Section 4.1 with respect to the Year [***], if Prothena purchases less than the Minimum Purchase Commitment, BI BIO shall charge a non-utilization fee of [***] of the Price, subject to Prothena mitigation with like-for-like [***] Products, and/or BI BIO mitigation pursuant to Section 4.7 (the “Non-Utilization-Fee”). Further, each Product Agreement shall stipulate Prothena’s obligation for reimbursement of BI BIO for any documented non-cancellable fees for raw materials and/or equipment |
4.7 | BI BIO shall undertake reasonable commercial efforts to fill any resulting excess capacity with third parties or its Affiliates for the manufacture of other biopharmaceutical products. For each Batch of Prothena’s capacity mitigated by BI BIO [***] in the event of termination or the Non-Utilization-Fee from Prothena shall not fall due. |
4.8 | In the event of a termination of a Product Addendum, as set forth in Section 2.7, Prothena may decrease the annual Minimum Purchase Commitment up to [***]. The decrease shall start the earliest as set forth in the table below after the receipt of Prothena’s respective notification by BI BIO and the Maximum Capacity Reservation shall be decreased accordingly. |
Termination for | Start of decrease of Minimum Purchase Commitment |
Clinical Failure Forced Withdrawal | [***] |
There was not a Clinical Failure, but there was [***] resulting in a [***] of [***] | [***] |
Convenience (any reason or no reason, incl. voluntary market withdrawal) | [***] |
5 | SUPPLY PRICE |
5.1. | The Price for Product shall be either a [***] of Product or a [***] of Product as further described in Appendix 4 to this Agreement, the MSA or the respective Product Agreement; and |
5.2. | The Price shall be index adjusted [***] once [***], subject to [***] maximum of [***], in accordance with this Section 5.2 and depending on the place of the Facility. In the event that the applicable index referred below is negative, the Price will not be adjusted for the [***] and stays the same as in the [***]. |
6 | CAPACITY LIMITATION |
6.1 | In the event of a Capacity Limitation, including but not limited to, a Capacity Limitation Threshold, Prothena’s Minimum Purchase Commitment and BI BIO’s Maximum Capacity Reservation shall be [***] in accordance with [***] of the affected Product. |
6.2 | If because of a Capacity Limitation, including but not limited to a Capacity Limitation Threshold, BI BIO cannot meet its obligation to Prothena under this Agreement and to other customers under other agreements, purchase orders or arrangements, BI BIO will allocate the available capacity to Prothena and its other third party customers on a pro rata basis, with Prothena's pro rata share being based on the [***] and on the [***] however, provided, that (i) a production unit technically suitable for the manufacture of Product(s) is available at a Facility and (ii) the manufacture of Product(s) in such technical suitable production unit is in compliance with all regulatory filings for the Product(s) and the Facilities. |
6.3 | In addition, in the event of a Capacity Limitation Threshold, Prothena shall have the right to request [***] Technology Transfer of the affected Product as shall be further detailed under the respective Product Agreement to (a) Prothena or (b) a third party manufacturer at [***] as described under Section 8.2 below. |
6.4 | Subject to Section 8 and Section 10.2, the pro rata share of capacity in accordance with Section 6.2 and 6.5, and the [***] Technology Transfer of the respective manufacturing process of a Product to Prothena or a third party manufacturer shall be the [***] due to Prothena for any decrease in the Maximum Capacity Reservation or amount of Product supplied under a Product Agreement due to a Capacity Limitation Threshold. Any liability and indemnification obligation of BI BIO in connection with a Capacity Limitation, including but not limited to, a Capacity Limitation Threshold shall be exclusively governed by Section 8. In the event of any inconsistencies or conflicts between this Agreement and the Existing Agreement, the provisions of this Agreement shall govern with respect to the Capacity Limitation, including but not limited to, a Capacity Limitation Threshold, and its consequences. |
6.5 | Upon the request of Prothena for a Technology Transfer of the affected Product according to Section 6.3, BI BIO shall continue to provide capacity for Product in accordance with Section 6.1 and 6.2 above until the [***] by Prothena or by the third party manufacturer [***]. |
7 | PAYMENT TERMS |
7.1 | For payments of any Non-Utilization-Fee due under this Agreement BI BIO shall invoice Prothena in [***] of every [***]. Prothena shall pay all amounts due within [***] from the date of receipt of the invoice by Prothena. |
7.2 | All invoices under this Agreement shall be made by BI BIO in Euro (€) and all payments under this Agreement shall be made by Prothena in Euro (€) by wire transfer to an account to be nominated by BI BIO. Prices and Fees shall be exclusive of statutory value added tax (“VAT”). VAT shall be added separately to each invoice and paid by Prothena if required by, and in accordance with, applicable laws. |
8 | INDEMNIFICATION / LIABILITIES |
8.1 | Disclaimer of Consequential Damages |
8.2 | Limitation of BI BIO’s Liability |
(i) | BI BIO is responsible for its subcontracted Affiliates to the same extent as for its own acts and omissions and the liability and indemnification obligations set forth herein are [***] in connection with this Agreement. For purposes of clarity and apart from cases of criminal activities, nothing in this Agreement shall entitle any Affiliate of Prothena or an Affiliate of BI BIO to make any claim against BI BIO or Prothena, respectively, under this Agreement, and |
(ii) | the manufacture and supply of the Products and the performance of the Services and all rights and obligations of the Parties in connection therewith shall be governed by and be subject to terms and provisions of the Product Agreements, including but not limited to the liability and indemnification provisions set forth in these agreements. With respect to the Existing Agreement and regarding any decrease in the Maximum Capacity Reservation or amount of Product supplied under the Existing Agreement due to a Capacity Limitation, including but not limited to, a Capacity Limitation Threshold and any liability and indemnification obligation in connection with such Capacity Limitation, including but not limited to, a Capacity Limitation Threshold is |
(iii) | If the Technology Transfer of a Product requires more support by BI BIO than [***] BI BIO man hours, BI BIO shall provide up to [***] additional man hours to Prothena and/or its third party manufacturer upon Prothena’s request and at Prothena’s expense (which shall be documented and calculated based on a daily rate of [***], --EUR (price basis 2017 and subject to Section 5.2)). |
8.3 | Limitation of Prothena’s Liability |
9 | CONFIDENTIALITY |
9.1 | Each Party shall treat all Confidential Information of the other Party strictly confidential, and shall only use or disclose such Confidential Information on a need-to-know basis in connection with the performance of its obligations under this Agreement, for corporate reporting purposes, or as permitted under this Agreement. Each Party may disclose the other Party’s Confidential Information to employees, contractors and agents who are bound by written obligations of confidentiality and non-use consistent with those set forth in this Agreement. |
9.2 | Each Party may disclose Confidential Information of the other Party hereunder to the extent that such disclosure is reasonably necessary for prosecuting or defending litigation, complying with applicable government regulations, provided that if a Party is required by law or regulation to make any such disclosure of the other Party’s Confidential Information it will give reasonable advance notice to the other Party of such disclosure requirement and will use its best efforts assist such other Party to secure a protective order or confidential treatment of such Confidential Information required to be disclosed, unless such advance notice is not feasible (e.g. medical emergency). |
9.3 | Prothena herewith notifies BI BIO that it may be required to publicly disclose the Agreement by filing it with the US. Securities and Exchange Commission (the “SEC”). Prothena shall share its redacted version of the Agreement with BI BIO prior to filing and shall take into account all reasonable requests, to the extent consistent with SEC rules, regulations and standards, from BI BIO concerning its Confidential Information. |
9.4 | Neither Party shall disclose Confidential Information of the other Party in any patent filings without the prior written consent of such other Party. |
9.5 | The Parties agree that, except as may otherwise be required by applicable laws, regulations, rules, or orders, no Confidential Information of the other Party or any material information regarding the transactions |
9.6 | Subject to any right to continued use as provided herein (such as, but not limited to, license rights), upon the disclosing Party’s written request, the receiving Party agrees to, at receiving Party’s discretion, either deliver to the disclosing Party or destroy all tangible information embodying the Confidential Information of the Disclosing Party and/or its Affiliates and all materials that constitute such Confidential Information, which are in the possession or under the control of the receiving Party or its Affiliates, in each case subject to the last sentence of this Section. In the event that the receiving Party elects to destroy the materials, upon destruction of such materials, the receiving Party will issue to the disclosing Party a certificate of destruction as proof of compliance with the disclosing Party’s request. The receiving Party further agrees not to retain any copies, notes or compilations of any written materials pertaining to the Confidential Information received from the disclosing Party or its Affiliates, save (i) that the receiving Party may retain one (1) copy of documentary Confidential Information for the sole purpose of monitoring its compliance with this Agreement, and (ii) for electronic back-up versions of Confidential Information, provided that they are created solely for back-up purposes based on a decentralized standardized back-up routine, are not accessible on standard individual user levels and are automatically and irrevocably deleted after fulfilment of their back-up purpose. |
9.7 | Prothena may disclose the existence and terms and conditions of this Agreement to (a) its potential and actual collaborators and partners, [***] and (b) potential or actual investment bankers, acquirers, lenders or investors, and (c) legal or financial advisors of Prothena. Any such disclosures shall be made under confidentiality provisions not less stringent than set forth in this Agreement and on a strict need-to-know basis. |
9.8 | Survival. The obligations of confidentiality and non use contained in this Section 9 shall survive the duration of this Agreement for a period of [***] years. |
10 | TERM / TERMINATION |
10.1 | This Agreement will come into force on the Effective Date and shall be valid until December 31, 2027 unless extended or terminated pursuant to this Section or the mutual written agreement of the Parties (the “Term”). |
10.2 | Termination by either Party: |
10.3 | Termination Rights of the Agreement by Prothena: |
a) Prothena may terminate this Agreement in the event of a Forced Withdrawal and/or Clinical Failure of either NEOD001 or all Products with [***] written notice. |
10.4 | CONSEQUENCE OF TERMINATION: |
(a) | In case of a termination of this Agreement by BI BIO pursuant to Section 10.2 a) and 10.2 b) (Termination in Case of Material Breach of the Agreement or Termination due to Insolvency) BI BIO shall be entitled to invoice Prothena for the [***] for [***] following the termination. |
(b) | In case of a termination of this Agreement by Prothena pursuant to Sections 10.2 a) and 10.2 b) (Termination in Case of Material Breach of the Agreement or Termination due to Insolvency) BI BIO shall upon Prothena’s request undertake a technology transfer of Product(s) to Prothena or a third party manufacturer at [***] expense as set forth under Section 8.2. |
(c) | Form of Termination: Any termination hereunder requires written form. |
11 | GOVERNING LAW / VENUE |
11.1 | Governing Law. This Agreement and the legal relations between the Parties in connection herewith shall be exclusively governed by, and construed in accordance with, the laws of [***], without regard to its conflict of law provisions. The Parties expressly exclude the [***]. |
11.2 | Exclusive Jurisdiction/Venue for Disputes. The Parties agree to consult with each other and to use their reasonable efforts to resolve any dispute and to refer a matter to arbitration under this Section 11.2 only as a last resort. As part of the reasonable efforts to resolve disputes, either Party may, by written notice to the other Party, have that dispute referred to a representative of each Party for attempted resolution by good faith negotiations. If these representatives are unable to resolve such dispute within [***] of referral or such other period the Parties agree upon in writing, each Party shall have the right to pursue the legal remedies set forth in this Section of this Agreement. All disputes arising out of or in connection with this Agreement shall be finally settled under the [***] by [***] appointed with the said Rules. The venue of the arbitration proceedings shall be [***]. The language of the arbitration proceedings shall be English. The costs of the arbitration (including reasonable attorney’s fees and associated costs and expenses) shall be [***]. |
12.1 | Relationship of the Parties. For the purposes of this Agreement, each Party shall be an independent contractor and not an agent or employee of the other Party. Neither Party shall have authority or power |
12.2 | Notices. Any notices which either Party may be required or shall desire to give under this Agreement shall be deemed to be duly given when in writing and delivered personally, mailed by registered mail, courier service or sent by telefax (provided that such telefax shall be confirmed by registered mail or courier service) to the Party to whom notice is to be given, at the address specified below (which may be amended upon at least [***] prior written notice to the other Party) or for any notices which either Party may be required or shall desire to give under any Appendix to this Agreement shall be given at the address specified in such Appendix. |
12.3 | Force Majeure. Failure of any Party to perform its obligations under this Agreement ([***] or of confidentiality) shall not subject such Party to any liability or place them in breach of any term or condition of this Agreement to the other Party if, and solely to the extent, such failure is caused by Force Majeure. The corresponding obligations of the other Party will be suspended to the same extent. “Force Majeure” shall mean any unanticipated event beyond a Party’s reasonable control that could not be avoided by due care of such non-performing Party, including without limitation, acts of God, fire, explosion, flood, earthquake, drought, war, hostility, revolution, riot, civil disturbance, national emergency, sabotage, embargo, strikes or other labour trouble; provided, however, that the Party affected shall promptly notify the other Party of the condition constituting Force Majeure as defined herein and shall exert commercially reasonable efforts to eliminate, cure and overcome any such causes and to resume performance of its obligations with all possible speed. If a condition constituting Force Majeure as defined herein prevents, or would likely prevent, a Party from performing its obligations under this |
12.4 | Entire Agreement. This Agreement (including the Appendices hereto) constitutes the entire agreement between the Parties related to the subject matter covered by this Agreement, shall supersede and prevail over any other prior or contemporaneous arrangements regarding this subject matter, whether written or oral and is binding upon the Parties hereto and their successors. No modification of this Agreement will be binding upon either Party unless made in writing and signed by both Parties. |
12.5 | Assignment. Neither Party may assign its rights and obligations under this Agreement without the other Party’s prior written consent, except that either Party may (a) assign its rights and obligations, in its entirety or for one of more Products, under this Agreement [***] to fulfil the assigned contractual duties and obligations and this Section 12.5 shall not apply to any such assignment; or (b) assign its rights and obligations under this Agreement, in its entirety or for one of more Products, to a successor to part of or to all or substantially all of its business or assets to which this Agreement relates. If either Party assigns its rights and obligations under this Agreement in accordance with this Section 12.5 other than in its entirety, such partial assignment shall not have the effect of [***]. |
12.6 | Severability. If any provision of this Agreement is held to be invalid or unenforceable, then the offending provision shall not render any other provision of this Agreement invalid or unenforceable, and the Agreement shall remain in full force and effect and shall be enforceable, unless the offending provision shall substantially affect the rights or obligations granted or undertaken by either Party. |
12.7 | Rule of Construction: The Parties have participated jointly in the negotiation and drafting of this Agreement. In the event that an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions of this Agreement. |
12.8 | Waiver. Nothing contained in this Agreement shall cause the failure of either Party hereto to insist upon strict compliance with any other provision hereof by the other Party to operate as a waiver with respect to such provision, unless such waiver is in writing and delivered to such other Party hereto. |
12.9 | Publicity. No press release or other form of publicity regarding this Agreement shall be permitted by either Party to be published unless both Parties have indicated their consent to the form of the release in writing. |
i. | Section 8 (Indemnification/Liabilities); |
ii. | Section 9 (Confidentiality); |
iii. | Section 10 (Effects of Termination or Expiration); |
iv. | Section 11 (Governing Law/Venue); and |
v. | Section 12.10 (Survivorship); |
PROTHENA THERAPEUTICS LIMITED Date: April 5, 2017 By: [***] Name: [***] Title: Director | BOEHRINGER INGELHEIM BIOPHARMACEUTICALS GBMH Date: April 5, 2017 By (ppa.): [***] [***] Head, Business & Contracts Contract Manufacturing Business, Biopharmaceuticals |
By (ppa.): [***] ______________________________ [***] Head of Legal Biopharma |
1. | Request for Proposal (RFP) outlining all inquired services and requested scale |
2. | List of Prothena materials which would be provided to undertake the technology transfer services and the manufacture of product (e.g. GMP WCB, reference standard, analytical reagents) |
3. | Technical Process information including process flow charts for upstream and downstream, and written process descriptions including: |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
4. | Analytical testing |
o | [***] |
o | [***] |
5. | [***] |
6. | [***] |
7. | [***] |
8. | [***] |
9. | [***] |
10. | [***] |
11. | [***] |
12. | [***] |
• | [***] |
• | [***] |
Parameter | Criteria |
Applicable Product format | • [***] • [***] • [***] |
Required Scale [working volume in L] | [***] |
Cell Line type | [***] |
Production platform | [***] |
Fermentation time [d] | [***] |
Purification time (from harvest to UDF) [hrs] | [***] |
Maximum column size [m] | [***] |
Titre for fed-batch processes [g/L] | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
• | [***] |
(a) | Total Capacity |
Year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | 2027 | |
Maximum Capacity Reservation by BI (run starts) | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | |
Minimum Purchase Commitment of Prothena (run starts) | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
Batch Type | Payment obligation of Prothena for forecasted/ordered Batches in accordance with the forecast mechanism of the applicable Product Agreement. |
a) [***] | [***] |
b) [***] | [***] |
c) [***] | [***] |
d) [***] | [***] |
(1) | NEOD001 |
Upstream | |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
Downstream | |
[***] | [***] |
[***] | [***] |
[***] | |
[***] | [***] |
Batches [***] | Price per Batch [***] (EUR, price basis 2016) |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
(2) | PRX003 |
Upstream | |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
Downstream | |
[***] | [***] |
[***] | [***] |
[***] | |
[***] | [***] |
Batches [***] | Price per Batch [***] (EUR, price basis 2016) |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
1. | I have reviewed this Quarterly Report on Form 10-Q of Prothena Corporation plc; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: | August 8, 2017 | /s/ Gene G. Kinney |
Gene G. Kinney | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) |
1. | I have reviewed this Quarterly Report on Form 10-Q of Prothena Corporation plc; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: | August 8, 2017 | /s/ Tran B. Nguyen |
Tran B. Nguyen | ||
Chief Financial Officer | ||
(Principal Financial Officer) |
1. | The Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2017, to which this Certification is attached as Exhibit 32.1 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: | August 8, 2017 | /s/ Gene G. Kinney |
Gene G. Kinney | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) | ||
/s/ Tran B. Nguyen | ||
Tran B. Nguyen | ||
Chief Financial Officer | ||
(Principal Financial Officer) | ||
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Document and Entity Information - shares |
6 Months Ended | |
---|---|---|
Jun. 30, 2017 |
Jul. 21, 2017 |
|
Document Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2017 | |
Document Fiscal Year Focus | 2017 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | PRTA | |
Entity Registrant Name | Prothena Corp plc | |
Entity Central Index Key | 0001559053 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Ordinary Shares Outstanding | 38,275,081 |
Condensed Consolidated Balance Sheets (Parenthetical) |
Jun. 30, 2017
$ / shares
shares
|
Jun. 30, 2017
€ / shares
shares
|
Dec. 31, 2016
$ / shares
shares
|
Dec. 31, 2016
€ / shares
shares
|
---|---|---|---|---|
Statement of Financial Position [Abstract] | ||||
Euro deferred shares, nominal value (in euros per share) | € / shares | € 22 | € 22 | ||
Euro deferred shares, number of shares authorized (in shares) | 10,000 | 10,000 | 10,000 | 10,000 |
Euro deferred shares, number of issued shares | 0 | 0 | 0 | 0 |
Euro deferred shares, number of outstanding shares (in shares) | 0 | 0 | 0 | 0 |
Ordinary shares, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | ||
Ordinary shares, number of authorized shares (in shares) | 100,000,000 | 100,000,000 | 100,000,000 | 100,000,000 |
Ordinary shares, number of issued shares (in shares) | 38,156,959 | 38,156,959 | 34,752,116 | 34,752,116 |
Ordinary shares, number of outstanding shares (in shares) | 38,156,959 | 38,156,959 | 34,752,116 | 34,752,116 |
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2017 |
Jun. 30, 2016 |
Jun. 30, 2017 |
Jun. 30, 2016 |
|
Income Statement [Abstract] | ||||
Collaboration revenue | $ 26,812 | $ 333 | $ 27,071 | $ 598 |
Total revenue | 26,812 | 333 | 27,071 | 598 |
Operating expenses: | ||||
Research and development | 34,032 | 32,359 | 59,730 | 52,852 |
General and administrative | 10,912 | 8,134 | 21,744 | 15,316 |
Total operating expenses | 44,944 | 40,493 | 81,474 | 68,168 |
Loss from operations | (18,132) | (40,160) | (54,403) | (67,570) |
Other income (expense): | ||||
Interest income (expense), net | 18 | (10) | (346) | 267 |
Other expense, net | (874) | (86) | (1,284) | (293) |
Total other expense, net | (856) | (96) | (1,630) | (26) |
Loss before income taxes | (18,988) | (40,256) | (56,033) | (67,596) |
Provision for (benefit from) income taxes | (1,287) | 189 | (2,948) | 370 |
Net loss | $ (17,701) | $ (40,445) | $ (53,085) | $ (67,966) |
Basic and diluted net loss per share (in dollars per share) | $ (0.46) | $ (1.18) | $ (1.44) | $ (1.99) |
Shares used to compute basic and diluted net loss per share (in shares) | 38,073 | 34,358 | 36,922 | 34,192 |
Organization |
6 Months Ended |
---|---|
Jun. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Description of Business Prothena Corporation plc and its subsidiaries (“Prothena” or the “Company”) is a global, late-stage clinical biotechnology company establishing fully-integrated research, development and commercial capabilities. Fueled by its deep scientific understanding built over decades of research in protein misfolding and cell adhesion - the root causes of many serious or currently untreatable amyloid and inflammatory diseases - Prothena seeks to fundamentally change the course of progressive diseases associated with this biology. The Company's pipeline of antibody-based product candidates target a number of potential indications including AL amyloidosis (NEOD001), Parkinson’s disease and other related synucleinopathies (PRX002/RG7935), inflammatory diseases including psoriasis and psoriatic arthritis (PRX003) and ATTR amyloidosis (PRX004). The Company continues discovery of additional novel therapeutic candidates where its deep scientific understanding of disease pathology can be leveraged. The Company is a public limited company formed under the laws of Ireland. The Company separated from Elan Corporation, plc (“Elan”) on December 20, 2012. After the separation from Elan, and the related distribution of the Company's ordinary shares to Elan’s shareholders, the Company's ordinary shares commenced trading on The Nasdaq Global Market under the symbol “PRTA” on December 21, 2012 and currently trade on The Nasdaq Global Select Market. Liquidity and Business Risks As of June 30, 2017, the Company had an accumulated deficit of $342.2 million and cash and cash equivalents of $471.7 million. In March 2017, the Company sold an aggregate of 2,700,000 ordinary shares for net proceeds of approximately $150.3 million, after deducting the underwriting discount and estimated offering expenses, in an underwritten public offering. Based on the Company's business plans, management believes that the Company's cash and cash equivalents at June 30, 2017 are sufficient to meet its obligations for at least the next twelve months. To operate beyond such period, or if the Company elects to increase its spending on development programs significantly above current long-term plans or enters into potential licenses and or other acquisitions of complementary technologies, products or companies, the Company may need additional capital. The Company expects to continue to finance future cash needs that exceed its cash from operating activities primarily through its current cash and cash equivalents, its collaboration with Roche, and to the extent necessary, through proceeds from public or private equity or debt financings, loans and other collaborative agreements with corporate partners or other arrangements. The Company is subject to a number of risks, including but not limited to: the uncertainty of the Company's research and development (“R&D”) efforts resulting in future successful commercial products; obtaining regulatory approval for its product candidates; its ability to successfully commercialize its product candidates, if approved; significant competition from larger organizations; reliance on the proprietary technology of others; dependence on key personnel; uncertain patent protection; dependence on corporate partners and collaborators; and possible restrictions on reimbursement from governmental agencies and healthcare organizations, as well as other changes in the healthcare industry. |
Summary of Significant Accounting Policies |
6 Months Ended |
---|---|
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Preparation and Presentation of Financial Information These accompanying Unaudited Interim Condensed Consolidated Financial Statements have been prepared in accordance with the accounting principles generally accepted in the U.S. (“GAAP”) and with the instructions for Form 10-Q and Regulation S-X statements. Accordingly, they do not include all of the information and notes required for complete financial statements. These interim Condensed Consolidated Financial Statements should be read in conjunction with the Consolidated Financial Statements and Notes thereto contained in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 27, 2017 (the "2016 Form 10-K"). These Unaudited Interim Condensed Consolidated Financial Statements are presented in U.S. dollars, which is the functional currency of the Company and its consolidated subsidiaries. These Unaudited Interim Condensed Consolidated Financial Statements include the accounts of the Company and its consolidated subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Unaudited Interim Financial Information The accompanying Unaudited Interim Condensed Consolidated Financial Statements and related disclosures are unaudited, have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair presentation of the results of operations for the periods presented. The year-end condensed consolidated balance sheet data was derived from audited financial statements, however certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. The condensed consolidated results of operations for any interim period are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. Certain amounts in the Condensed Consolidated Financial Statements have been reclassified to conform to the current year presentation. Use of Estimates The preparation of the Condensed Consolidated Financial Statements in conformity with GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates, including critical accounting policies or estimates related to revenue recognition, share-based compensation and research and development expenses. The Company bases its estimates on historical experience and on various other market specific and other relevant assumptions that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Because of the uncertainties inherent in such estimates, actual results may differ materially from these estimates. Significant Accounting Policies There were no significant changes to the accounting policies during the six months ended June 30, 2017, from the significant accounting policies described in Note 2 of the "Notes to Consolidated Financial Statements" in the 2016 Form 10-K, with the exception of those noted below. Share-based Compensation To determine the fair value of share-based payment awards, the Company uses the Black-Scholes option-pricing model. The determination of fair value using the Black-Scholes option-pricing model is affected by the Company’s share price as well as assumptions regarding a number of complex and subjective variables. Share-based compensation expense is recognized on a straight-line basis over the requisite service period for each award. Further, share-based compensation expense recognized in the Condensed Consolidated Statements of Operations is based on awards expected to vest and therefore the amount of expense has been reduced for estimated forfeitures. If actual forfeitures differ from estimates at the time of grant they will be revised in subsequent periods. The Company bases its assumptions on historical data when available or when not available, on a peer group of companies. If factors change and different assumptions are employed in determining the fair value of share-based awards, the share-based compensation expense recorded in future periods may differ significantly from what was recorded in the current period(see Note 10 for further information). The Company will record any excess tax benefits or deficiencies from its equity awards in its Condensed Consolidated Statements of Operations in the reporting periods in which stock options are exercised. Segment and Concentration of Risks The Company operates in one segment. The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on a consolidated basis for purposes of allocating resources. When evaluating the Company’s financial performance, the CODM reviews all financial information on a consolidated basis. Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents and accounts receivable. The Company places its cash equivalents with high credit quality financial institutions and by policy, limits the amount of credit exposure with any one financial institution. Deposits held with banks may exceed the amount of insurance provided on such deposits. The Company has not experienced any losses on its deposits of cash and cash equivalents and its credit risk exposure is up to the extent recorded on the Company's Condensed Consolidated Balance Sheet. Receivable from Roche as of June 30, 2017 and December 31, 2016 are amounts due from Roche entities located in the U.S. and Switzerland under the License Agreement that became effective January 22, 2014. Revenue recorded in the Statements of Operations consists of reimbursement from Roche for research and development services. Credit risk exposure is up to the extent recorded on the Company's Condensed Consolidated Balance Sheet. As of June 30, 2017, $55.1 million of the Company's long-lived assets were held in the U.S. and $0.7 million were in Ireland. As of December 31, 2016, $55.7 million of the Company's long-lived assets were held in the U.S. and $0.8 million were in Ireland. The Company does not own or operate facilities for the manufacture, packaging, labeling, storage, testing or distribution of nonclinical or clinical supplies of any of its drug candidates, including for commercial supplies if the Company obtains regulatory approval to market any of its drug candidates. The Company instead contracts with and relies on third-parties to manufacture, package, label, store, test and distribute all pre-clinical development and clinical supplies of our drug candidates, and it plans to continue to do so for the foreseeable future, including for commercial supplies if the Company obtains regulatory approval to market any of its drug candidates. The Company also relies on third-party consultants to assist in managing these third-parties and assist with its manufacturing strategy. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 supersedes the revenue recognition requirements in Revenue Recognition (Topic 605). The new standard requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. To achieve that core principle, an entity must identify the contract(s) with a customer, identify the performance obligations in the contract, determine the transaction price, allocate the transaction price to the performance obligations in the contract, and recognize revenue when (or as) the entity satisfies the performance obligation. ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period, which for the Company is January 1, 2018. Early adoption is permitted after January 1, 2017. The standard allows for two transition methods - retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying the standard recognized at the date of initial adoption. The Company expects to adopt the requirements of the new standard effective January 1, 2018 using the retrospective with the cumulative effect transition method. In March 2016, the FASB issued ASU No. 2016-08 Revenue from Contracts with Customers: Principal vs. Agent Considerations, to help provide interpretive clarifications on the new guidance for ASC Topic 606. In April 2016, the FASB issued ASU No. 2016-10 Revenue from Contracts with Customers: Identifying Performance Obligations and Licensing to clarify the guidance for identifying performance obligations and accounting for licenses of intellectual property. In May 2016, the FASB issued ASU No. 2016-12 Revenue from Contracts with Customers: Narrow-Scope Improvements; and Practical Expedients, to improve the guidance on collectibility, noncash consideration, and completed contracts at transition. In December 2016, the FASB issued ASU No. 2016-20 Revenue from Contracts with Customers: Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. The Company continues to evaluate the impact that the adoption of these standards will have on its consolidated financial statements in connection with the Roche License Agreement. In February 2016, the FASB issued Accounting Standards Update 2016-02 (ASU 2016-02), Leases (ASC Topic 842), which will require lessees to recognize assets and liabilities for leases with lease terms of more than 12 months. Consistent with current GAAP, the recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee primarily will depend on its classification as a finance or operating lease. However, unlike current GAAP, which requires only capital leases to be recognized on the balance sheet, the new guidance will require both types of leases to be recognized on the balance sheet. ASU 2016-02 is effective for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. The standard requires that entities use a modified retrospective approach for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements. Entities have the option to use certain relief. Full retrospective application is prohibited. Note 7 Commitments and Contingencies provides details on the Company's current lease arrangements. The Company is evaluating the provisions of ASC Topic 842 to determine the impact the adoption of ASU 2016-02 will have on its consolidated financial statements; however, the Company anticipates recognition of additional assets and corresponding liabilities related to leases on its consolidated balance sheets. Additionally, it is possible that the Company will derecognize its build-to-suit asset and liabilities upon adoption pending its final evaluation. In March 2016, the FASB issued Accounting Standards Update 2016-09 (ASU 2016-09), Improvements to Employee Share-Based Payment Accounting, which modifies certain aspects of the accounting for share-based payment transactions, including income taxes, classification of awards and classification in the statement of cash flows. Through December 31, 2016, excess tax benefits or deficiencies from the Company's equity awards were recorded as additional paid-in capital in its Consolidated Balance Sheets. Upon adoption, the Company will record any excess tax benefits or deficiencies from its equity awards in its Condensed Consolidated Statements of Operations in the reporting periods in which stock options are exercised. This guidance also requires excess tax benefits and deficiencies to be presented as an operating activity on the statement of cash flows and allows an entity to make an accounting policy election to either estimate expected forfeitures or to account for them as they occur. The ASU is effective for reporting periods beginning after December 15, 2016, with early adoption permitted. The Company adopted this ASU on January 1, 2017. Pursuant to the adoption of ASU 2016-09, tax attributes previously tracked off balance sheet have been recorded as deferred tax assets, offset by a valuation allowance. In addition, the Company has reversed its non-current tax liability of $98,000 with the offsetting entry recorded to retained earnings pursuant to the adoption of this ASU. Further, the year-to-date excess benefits have been recorded as a discrete benefit to the tax provision. For the six months ended June 30, 2017, the Company recorded excess tax benefits of $3.4 million as part of its income tax provision in the Condensed Consolidated Statements of Operations. The Company's income tax expense will continue to be impacted by fluctuations in stock price between the grant dates and the exercise dates of its option awards. The presentation requirements for cash flows related to excess tax benefits will be applied retrospectively; as such, prior years have been restated. Lastly, the Company elected to continue to estimate the number of forfeitures related to share-based payments, rather than account for forfeitures as they occur. In August 2016, the FASB issued Accounting Standards Update 2016-15 (ASU 2016-15), Statement of Cash Flows - Classification of Certain Cash Receipts and Cash Payments, which clarifies existing guidance related to accounting for cash receipts and cash payments and classification of statement of cash flow. This guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, and early adoption is permitted. The Company does not expect the adoption of ASU 2016-15 to have an impact on its consolidated financial statements. In May 2017, the FASB issued Accounting Standards Update 2017-09 (ASU 2017-09), Compensation - Stock Compensation (Topic 718) - Scope of Modification Accounting, which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. Entities would apply the modification accounting guidance if the value, vesting requirements or classification of a share-based payment award changes. This pronouncement is effective for annual reporting periods beginning after December 15, 2017 but early adoption is permitted. The Company does not expect the adoption of ASU 2017-09 to have an impact on its consolidated financial statements. |
Fair Value Measurements |
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Fair Value Disclosures [Abstract] | |||||||||
Fair Value Measurements | Fair Value Measurements The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. A three-tier fair value hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value: Level 1 — Observable inputs such as quoted prices (unadjusted) for identical assets or liabilities in active markets.
The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The carrying amounts of certain financial instruments, such as cash equivalents, accounts receivable, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities, and low market interest rates, if applicable. Based on the fair value hierarchy, the Company classifies its cash equivalents within Level 1. This is because the Company values its cash equivalents using quoted market prices. The Company’s Level 1 securities consist of $385.9 million and $307.3 million in money market funds included in cash and cash equivalents at June 30, 2017 and December 31, 2016, respectively. |
Composition of Certain Balance Sheet Items |
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Composition of Certain Balance Sheet Items [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Composition of Certain Balance Sheet Items | Composition of Certain Balance Sheet Items Property and Equipment, net Property and equipment, net consisted of the following (in thousands):
Depreciation expense was $0.8 million and $1.5 million for the three and six months ended June 30, 2017, respectively, compared to $0.4 million and $0.7 million for the three and six months ended June 30, 2016, respectively. Other Current Liabilities Other current liabilities consisted of the following (in thousands):
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Net Loss Per Ordinary Share |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Income (Loss) Per Ordinary Share | Net Income (loss) Per Ordinary Share Basic net income (loss) per ordinary share is calculated by dividing net income (loss) by the weighted-average number of ordinary shares outstanding during the period. Shares used in diluted net income per ordinary share would include the dilutive effect of ordinary shares potentially issuable upon the exercise of stock options outstanding. However, potentially issuable ordinary shares are not used in computing diluted net loss per ordinary share as their effect would be anti-dilutive due to the loss recorded during the three and six months ended June 30, 2017 and 2016, and therefore diluted net loss per share is equal to basic net loss per share. Net loss per ordinary share was determined as follows (in thousands, except per share amounts):
The equivalent ordinary shares not included in diluted net loss per share because their effect would be anti-dilutive are as follows (in thousands):
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Build-to-Suit Lease |
6 Months Ended |
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Jun. 30, 2017 | |
Leases [Abstract] | |
Build-to-Suit Lease | Build-to-Suit Lease In March 2016, the Company entered into a noncancelable operating sublease (the "Lease") to lease 128,751 square feet of office and laboratory space in South San Francisco, California (the “Current SSF Facility”). Subsequently, in April 2016, the Company took possession of the Current SSF Facility. The Lease includes a free rent period and escalating rent payments and has a term that expires on December 31, 2023, unless terminated earlier. The Company's obligation to pay rent commenced on August 1, 2016. The Company is obligated to make lease payments totaling approximately $39.2 million over the lease term. The Lease further provides that the Company is obligated to pay to the sublandlord and master landlord certain costs, including taxes and operating expenses. Expected future lease payments under the build-to-suit lease as of June 30, 2017 are included in Note 7, “Commitments and Contingencies.” In connection with this Lease, the Company received a tenant improvement allowance of $14.2 million from the sublandlord and the master landlord, for the costs associated with the design, development and construction of tenant improvements for the Current SSF Facility. The Company is obligated to fund all costs incurred in excess of the tenant improvement allowance. The scope of the tenant improvements did not qualify as “normal tenant improvements” under the lease accounting guidance. Accordingly, for accounting purposes, the Company is the deemed owner of the building during the construction period and the Company capitalized $36.5 million within property and equipment, net, including $1.2 million for capitalized interest and recognized a corresponding build-to-suit obligation in other non-current liabilities in the Condensed Consolidated Balance Sheets as of June 30, 2017. The Company has also recognized structural and non-structural tenant improvements totaling $15.3 million as of June 30, 2017 as an addition to the build-to-suit lease property for amounts incurred by the Company during the construction period, of which $14.2 million were reimbursed by the landlord during the year ended December 31, 2016 through the tenant improvement allowance. The Company increased its financing obligation for the additional building costs reimbursements received from the landlord during the construction period. In addition, for the three and six months ended June 30, 2017, the Company recorded rent expense associated with the ground lease of $0.1 million and $0.2 million, respectively, in the Condensed Consolidated Statements of Operations. Total interest, which represents the cost of financing obligation under the Lease agreement, was $0.9 million and $1.8 million for the three and six months ended June 30, 2017, respectively, of which $0.9 million and $1.8 million, respectively, was recognized within the Condensed Consolidated Statement of Operations. During the fourth quarter of 2016, construction on the build-to-suit lease property was substantially completed and the build-to-suit lease property was placed in service. As such, the Company evaluated the Lease to determine whether it had met the requirements for sale-leaseback accounting, including evaluating whether all risks of ownership have been transferred back to the landlord, as evidenced by a lack of continuing involvement in the build-to-suit lease property. The Company determined that the construction project did not qualify for sale-leaseback accounting and will instead be accounted for as a financing lease, given the Company’s expected continuing involvement after the conclusion of the construction period. The build-to-suit lease property remains on the Company’s Condensed Consolidated Balance Sheets as of June 30, 2017 at its historical cost of $51.8 million and is being depreciated over its estimated useful life. As of June 30, 2017, the total amount of the build-to-suit lease obligation was $52.1 million, which is classified as a non-current liability on the Condensed Consolidated Balance Sheets. The Company expects to derecognize the build-to-suit lease property and financing lease obligation at the end of the lease term. The Company obtained a standby letter of credit in April 2016 in the initial amount of $4.1 million, which may be drawn down by the sublandlord in the event the Company fails to fully and faithfully perform all of its obligations under the Lease and to compensate the sublandlord for all losses and damages the sublandlord may suffer as a result of the occurrence of any default on the part of Company not cured within the applicable cure period. This standby letter of credit is collateralized by a certificate of deposit of the same amount which is classified as restricted cash. As of June 30, 2017, none of the standby letter of credit amount has been used. |
Commitment and Contingencies |
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Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitment and Contingencies | Commitments and Contingencies Lease Commitments The Company recognizes rent expense for its operating leases on a straight-line basis over the noncancelable lease term and records the difference between cash rent payments and the recognition of rent expense as a deferred rent liability. Where leases contain escalation clauses, rent abatements, and/or concessions, such as rent holidays and landlord or tenant incentives or allowances, the Company applies them in the determination of straight-line rent expense over the lease term. The Company records the tenant improvement allowance for operating leases as deferred rent and associated expenditures as leasehold improvements that are being amortized over the shorter of their estimated useful life or the term of the lease. Rent expense was $0.2 million and $0.5 million for the three and six months ended June 30, 2017, respectively. Rent expense was $0.6 million and $1.0 million for the three and six months ended June 30, 2016, respectively. Dublin In August 2015, the Company entered into an agreement to lease 6,258 square feet of office space in Dublin, Ireland. This lease has a term of 10 years from commencement and provides for an option to terminate the lease at the end of the fifth year of the term. It is also subject to a rent review every five years. As a result of this noncancelable operating lease, the Company is obligated to make lease payments totaling approximately €2.0 million, or $2.3 million as converted using an exchange rate as of June 30, 2017, over the term of the lease, assuming current lease payments. Of this obligation, approximately $1.9 million remains outstanding as of June 30, 2017. Future minimum payments under the above-described noncancelable operating lease as of June 30, 2017 are as follows (in thousands):
Current SSF Facility In March 2016, the Company entered into a noncancelable operating sublease of the Current SSF Facility which expires in December 31, 2023. The Company is considered the "accounting owner" of the Current SSF Facility as a build-to-suit property and has recorded a build-to-suit lease obligation on its condensed consolidated balance sheet. Additional information regarding the build-to-suit lease is included in Note 6, "Build-To-Suit Lease." Future minimum payments under build-to-suit lease obligation as of June 30, 2017 are as follows (in thousands):
Indemnity Obligations The Company has entered into indemnification agreements with its current, and former, directors and officers and certain key employees. These agreements contain provisions that may require the Company, among other things, to indemnify such persons against certain liabilities that may arise because of their status or service and advance their expenses incurred as a result of any indemnifiable proceedings brought against them. The obligations of the Company pursuant to the indemnification agreements continue during such time as the indemnified person serves the Company and continues thereafter until such time as a claim can be brought. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited; however, the Company has a director and officer liability insurance policy that limits its exposure and enables the Company to recover a portion of any future amounts paid. As a result of its insurance policy coverage, the Company believes the estimated fair value of these indemnification agreements is minimal. Accordingly, the Company had no liabilities recorded for these agreements as of June 30, 2017 and 2016. Other Commitments In April 2017, the Company entered into a Letter Agreement with Boehringer Ingelheim Biopharmacuticals GmbH for commercial supply of drug products. No product has been manufactured under this agreement. However, the commitment table below includes purchase obligations under this agreement. In the normal course of business, the Company enters into various firm purchase commitments primarily related to research and development activities. As of June 30, 2017, the Company had non-cancelable purchase commitments to suppliers for $44.9 million of which $12.8 million is included in accrued current liabilities, and contractual obligations under license agreements of $1.7 million of which $0.3 million is included in accrued current liabilities. The following is a summary of the Company's non-cancelable purchase commitments and contractual obligations as of June 30, 2017 (in thousands):
(1) Excludes future obligations pursuant to the cost-sharing arrangement under the Company's License Agreement with Roche. Amounts of such obligations, if any, cannot be determined at this time. |
Roche License Agreement |
6 Months Ended |
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Jun. 30, 2017 | |
Collaborative Agreement [Abstract] | |
Roche License Agreements | Roche License Agreement Overview In December 2013, the Company entered into the License Agreement with Roche to develop and commercialize certain antibodies that target α-synuclein, including PRX002. The License Agreement was evaluated under ASC 605-25, Multiple Element Arrangements. Under this License agreement, the Company recognizes research reimbursement as collaboration revenue as earned. The Company recognized $0.2 million and $0.5 million and as collaboration revenue for research reimbursement from Roche for the three and six months ended June 30, 2017, respectively, as compared to $0.3 million and $0.6 million for the three and six months ended June 30, 2016, respectively. Cost sharing payments to Roche are recorded as R&D expenses. The Company recognized $2.9 million and $4.2 million in R&D expenses for payments made to Roche during the three and six months ended June 30, 2017, respectively, as compared to $0.9 million and $1.4 million for the three and six months ended June 30, 2016, respectively. Reimbursement for development costs from Roche during the three and six months ended June 30, 2017 was $0.4 million and $1.2 million, respectively, as compared to $0.7 million and $1.9 million for the three and six months ended June 30, 2016, respectively, which was recognized as an offset to R&D expenses. Under the License Agreement, the Company is eligible to receive milestone payments upon the achievement of development, regulatory and various first commercial sales milestones. Milestone payments are evaluated under ASU No. 2010-17, Milestone Method of Revenue Recognition. Factors considered in this determination included scientific and regulatory risk that must be overcome to achieve each milestone, the level of effort and investment required to achieve the milestone, and the monetary value attributed to the milestone. Accordingly, the Company recognizes payments related to the achievement of this milestone when the milestone is achieved. The clinical and regulatory milestones under the License Agreement after the point at which the Company could opt-out are not considered to be substantive due to the fact that active participation in the development activities that generate the milestones is not required by the License Agreement, and the Company can opt-out of these activities. There are no refund or claw-back provisions and the milestones are uncertain of occurrence even after the Company has opted out. Based on this determination, these milestones will be recognized similar to the commercial milestone, which will be accounted for as contingent revenue payments with revenue recognized upon achievement of the milestone assuming all revenue recognition criteria are met. In June 2017, the Company achieved a $30.0 million clinical milestone under the License Agreement as a result of dosing of first patient in Phase 2 study for PRX002. The milestone was allocated to the units of accounting based on the relative selling price method for income statement classification purposes. As such, the Company recognized $26.6 million of the $30.0 million milestone as collaboration revenue and $3.4 million as an offset to R&D expenses during the three and six months ended June 30, 2017. The Company did not achieve any clinical and regulatory milestones under the License Agreement during the three and six months ended June 30, 2016. |
Shareholders' Equity |
6 Months Ended |
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Jun. 30, 2017 | |
Equity [Abstract] | |
Shareholders' Equity | Shareholders' Equity Ordinary Shares As of June 30, 2017, the Company had 100,000,000 ordinary shares authorized for issuance with a par value of $0.01 per ordinary share and 38,156,959 ordinary shares issued and outstanding. Each ordinary share is entitled to one vote and, on a pro rata basis, to dividends when declared and the remaining assets of the Company in the event of a winding up. Euro Deferred Shares As of June 30, 2017, the Company had 10,000 Euro Deferred Shares authorized for issuance with a nominal value of €22 per share. No Euro Deferred Shares are outstanding at June 30, 2017. The rights and restrictions attaching to the Euro Deferred Shares rank pari passu with the ordinary shares and are treated as a single class in all respects. March 2017 Offering In March 2017, the Company completed an underwritten public offering of an aggregate of 2,700,000 of its ordinary shares at a public offering price of $57.50 per ordinary share. The Company received aggregate net proceeds of approximately $150.3 million, after deducting the underwriting discount and estimated offering costs. |
Share-Based Compensation |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Compensation | Share-Based Compensation Amended and Restated 2012 Long Term Incentive Plan (“LTIP”) Employees and consultants of the Company, its subsidiaries and affiliates, as well as members of the Board, are eligible to receive equity awards under the LTIP. The LTIP provides for the grant of stock options, including incentive stock options and nonqualified stock options, stock appreciation rights (“SARS”), restricted shares, restricted share units ("RSUs"), cash or stock-based performance awards and other share-based awards to eligible individuals. Options under the LTIP may be granted for periods up to ten years. All options issued to date have had a ten year life. The Company granted 430,000 and 1,284,800 share options during the three and six months ended June 30, 2017, respectively, and 112,000 and 1,120,475 shares options during the three and six months ended June 30, 2016 respectively, under the LTIP. The Company's option awards generally vest over four years. In May 2017, the Company's shareholders approved an increase of 1,350,000 additional ordinary shares authorized for issuance under the LTIP. The aggregate number of ordinary shares authorized for issuance under the LTIP is 8,750,000 ordinary shares, and as of June 30, 2017, 2,385,851 ordinary shares remained available for grant and options to purchase 4,608,451 ordinary shares granted from the LTIP were outstanding with a weighted-average exercise price of approximately $36.20 per share. Share-based Compensation Expense The Company estimates the fair value of share-based compensation on the date of grant using an option-pricing model. The Company uses the Black-Scholes model to value share-based compensation, excluding RSUs, which the Company values using the fair market value of its ordinary shares on the date of grant. The Black-Scholes option-pricing model determines the fair value of share-based payment awards based on the share price on the date of grant and is affected by assumptions regarding a number of complex and subjective variables. These variables include, but are not limited to, the Company’s share price, volatility over the expected life of the awards and actual and projected employee stock option exercise behaviors. Since the Company does not have sufficient historical employee share option exercise data, the simplified method has been used to estimate the expected life of all options. The expected volatility was based on a combination of historical volatility for the Company's stock and the historical volatilities of several of the Company's publicly traded comparable companies. Although the fair value of share options granted by the Company is estimated by the Black-Scholes model, the estimated fair value may not be indicative of the fair value observed in a willing buyer and seller market transaction. As share-based compensation expense recognized in the Condensed Consolidated Financial Statements is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from estimates. Forfeitures were estimated based on estimated future turnover and historical experience. Share-based compensation expense will continue to have an adverse impact on the Company’s results of operations, although it will have no impact on its overall financial position. The amount of unearned share-based compensation currently estimated to be expensed from now through the year 2020 related to unvested share-based payment awards at June 30, 2017 is $73.8 million. The weighted-average period over which the unearned share-based compensation is expected to be recognized is 2.97 years. If there are any modifications or cancellations of the underlying unvested securities, the Company may be required to accelerate and/or increase any remaining unearned share-based compensation expense. Future share-based compensation expense and unearned share-based compensation will increase to the extent that the Company grants additional equity awards. Share-based compensation expense recorded in these Condensed Consolidated Financial Statements for the three and six months ended June 30, 2017 and 2016 was based on awards granted under the LTIP. The following table summarizes share-based compensation expense for the periods presented (in thousands):
For the three and six months ended June 30, 2017, the Company recognized tax benefit from share-based awards of $1.1 million and $1.9 million, respectively, and $0.7 million and $1.4 million during the three and six months ended June 30, 2016, respectively. The fair value of the options granted to employees and non-employee directors during the three and six months ended June 30, 2017 and 2016 was estimated as of the grant date using the Black-Scholes option-pricing model assuming the weighted-average assumptions listed in the following table:
The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period for each award. Each of the inputs discussed above is subjective and generally requires significant management judgment to determine. The following table summarizes the Company’s stock option activity during the six months ended June 30, 2017:
During the three and six months ended June 30, 2017, the total intrinsic value of options exercised was $8.9 million and $25.9 million, respectively, and $1.1 million and $1.4 million during the three and six months ended June 30, 2016, respectively, determined as of the date of exercise. |
Income Taxes |
6 Months Ended |
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Jun. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The major taxing jurisdictions for the Company are Ireland and the U.S. The Company recorded an income tax benefit of $1.3 million and $2.9 million for three and six months ended June 30, 2017, respectively, as compared to an income tax expense of $189,000 and $370,000 for the three and six months ended June 30, 2016, respectively. The provision for income taxes differs from the statutory tax rate of 12.5% applicable to Ireland primarily due to Irish net operating losses for which a tax provision benefit is not recognized, U.S. income taxed at different rates, and excess tax benefits of stock options. The income tax provision reflects the estimate of the effective tax rate expected to be applicable for the full year and the Company re-evaluates this estimate each quarter based on its forecasted tax expense for the full year. Jurisdictions with a projected loss for the year where no tax benefit can be recognized are excluded from the estimated annual effective tax rate. The Company adopted ASU 2016-09 on January 1, 2017. Pursuant to the adoption of ASU 2016-09, tax attributes previously tracked off balance sheet have been recorded as deferred tax assets, offset by a valuation allowance. In addition, the Company has reversed its non-current tax liability of $98,000, with the offsetting entry recorded to retained earnings pursuant to the adoption of this ASU. Further, the year-to-date excess benefits have been recorded as a discrete benefit to the tax provision. For the three and six months ended June 30, 2017, the Company recorded excess tax benefits of $1.5 million and $3.4 million, respectively, which were recorded as part of its income tax provision in the Condensed Consolidated Statements of Operations. The Company's income tax expense will continue to be impacted by fluctuations in stock price between the grant dates and the exercise dates of its option awards. The Company's deferred tax assets are composed primarily of its Irish subsidiaries' net operating loss carryovers, state net operating loss carryforwards available to reduce future taxable income of the Company's U.S. subsidiary, federal and California research and development credit carryforward, shared-based compensation and other temporary differences. The Company maintains a valuation allowance against certain U.S. federal and state and Irish deferred tax assets. Each reporting period, the Company evaluates the need for a valuation allowance on its deferred tax assets by jurisdiction. No provision for income tax in Ireland has been recognized on undistributed earnings of the Company's U.S. subsidiary because the Company considers such earnings to be indefinitely reinvested. |
Related Parties |
6 Months Ended |
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Jun. 30, 2017 | |
Related Party Transactions [Abstract] | |
Related Parties | Related Parties Carol D. Karp commenced employment with the Company as its Chief Regulatory Officer on December 14, 2016. Prior to that, Ms. Karp provided consulting services to the Company under a written Consulting Agreement which was effective April 1, 2016. That Consulting Agreement terminated as of December 13, 2016, before Ms. Karp joined the Company. There were no consulting fees paid to Ms. Karp for the three and six months ended June 30, 2017. The Company paid a total of $68,600 (not including expense reimbursements) for the three and six months ended June 30, 2016 under the Consulting Agreement. |
Summary of Significant Accounting Policies (Policies) |
6 Months Ended |
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Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Basis of Preparation and Presentation of Financial Information | Basis of Preparation and Presentation of Financial Information These accompanying Unaudited Interim Condensed Consolidated Financial Statements have been prepared in accordance with the accounting principles generally accepted in the U.S. (“GAAP”) and with the instructions for Form 10-Q and Regulation S-X statements. Accordingly, they do not include all of the information and notes required for complete financial statements. These interim Condensed Consolidated Financial Statements should be read in conjunction with the Consolidated Financial Statements and Notes thereto contained in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 27, 2017 (the "2016 Form 10-K"). These Unaudited Interim Condensed Consolidated Financial Statements are presented in U.S. dollars, which is the functional currency of the Company and its consolidated subsidiaries. These Unaudited Interim Condensed Consolidated Financial Statements include the accounts of the Company and its consolidated subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Unaudited Interim Financial Information The accompanying Unaudited Interim Condensed Consolidated Financial Statements and related disclosures are unaudited, have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair presentation of the results of operations for the periods presented. The year-end condensed consolidated balance sheet data was derived from audited financial statements, however certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. The condensed consolidated results of operations for any interim period are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. Certain amounts in the Condensed Consolidated Financial Statements have been reclassified to conform to the current year presentation. |
Use of Estimates | Use of Estimates The preparation of the Condensed Consolidated Financial Statements in conformity with GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates, including critical accounting policies or estimates related to revenue recognition, share-based compensation and research and development expenses. The Company bases its estimates on historical experience and on various other market specific and other relevant assumptions that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Because of the uncertainties inherent in such estimates, actual results may differ materially from these estimates. |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | Share-based Compensation To determine the fair value of share-based payment awards, the Company uses the Black-Scholes option-pricing model. The determination of fair value using the Black-Scholes option-pricing model is affected by the Company’s share price as well as assumptions regarding a number of complex and subjective variables. Share-based compensation expense is recognized on a straight-line basis over the requisite service period for each award. Further, share-based compensation expense recognized in the Condensed Consolidated Statements of Operations is based on awards expected to vest and therefore the amount of expense has been reduced for estimated forfeitures. If actual forfeitures differ from estimates at the time of grant they will be revised in subsequent periods. The Company bases its assumptions on historical data when available or when not available, on a peer group of companies. If factors change and different assumptions are employed in determining the fair value of share-based awards, the share-based compensation expense recorded in future periods may differ significantly from what was recorded in the current period(see Note 10 for further information). The Company will record any excess tax benefits or deficiencies from its equity awards in its Condensed Consolidated Statements of Operations in the reporting periods in which stock options are exercised. |
Segment and Concentration of Risk | Segment and Concentration of Risks The Company operates in one segment. The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on a consolidated basis for purposes of allocating resources. When evaluating the Company’s financial performance, the CODM reviews all financial information on a consolidated basis. Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents and accounts receivable. The Company places its cash equivalents with high credit quality financial institutions and by policy, limits the amount of credit exposure with any one financial institution. Deposits held with banks may exceed the amount of insurance provided on such deposits. The Company has not experienced any losses on its deposits of cash and cash equivalents and its credit risk exposure is up to the extent recorded on the Company's Condensed Consolidated Balance Sheet. Receivable from Roche as of June 30, 2017 and December 31, 2016 are amounts due from Roche entities located in the U.S. and Switzerland under the License Agreement that became effective January 22, 2014. Revenue recorded in the Statements of Operations consists of reimbursement from Roche for research and development services. Credit risk exposure is up to the extent recorded on the Company's Condensed Consolidated Balance Sheet. As of June 30, 2017, $55.1 million of the Company's long-lived assets were held in the U.S. and $0.7 million were in Ireland. As of December 31, 2016, $55.7 million of the Company's long-lived assets were held in the U.S. and $0.8 million were in Ireland. The Company does not own or operate facilities for the manufacture, packaging, labeling, storage, testing or distribution of nonclinical or clinical supplies of any of its drug candidates, including for commercial supplies if the Company obtains regulatory approval to market any of its drug candidates. The Company instead contracts with and relies on third-parties to manufacture, package, label, store, test and distribute all pre-clinical development and clinical supplies of our drug candidates, and it plans to continue to do so for the foreseeable future, including for commercial supplies if the Company obtains regulatory approval to market any of its drug candidates. The Company also relies on third-party consultants to assist in managing these third-parties and assist with its manufacturing strategy. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 supersedes the revenue recognition requirements in Revenue Recognition (Topic 605). The new standard requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. To achieve that core principle, an entity must identify the contract(s) with a customer, identify the performance obligations in the contract, determine the transaction price, allocate the transaction price to the performance obligations in the contract, and recognize revenue when (or as) the entity satisfies the performance obligation. ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period, which for the Company is January 1, 2018. Early adoption is permitted after January 1, 2017. The standard allows for two transition methods - retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying the standard recognized at the date of initial adoption. The Company expects to adopt the requirements of the new standard effective January 1, 2018 using the retrospective with the cumulative effect transition method. In March 2016, the FASB issued ASU No. 2016-08 Revenue from Contracts with Customers: Principal vs. Agent Considerations, to help provide interpretive clarifications on the new guidance for ASC Topic 606. In April 2016, the FASB issued ASU No. 2016-10 Revenue from Contracts with Customers: Identifying Performance Obligations and Licensing to clarify the guidance for identifying performance obligations and accounting for licenses of intellectual property. In May 2016, the FASB issued ASU No. 2016-12 Revenue from Contracts with Customers: Narrow-Scope Improvements; and Practical Expedients, to improve the guidance on collectibility, noncash consideration, and completed contracts at transition. In December 2016, the FASB issued ASU No. 2016-20 Revenue from Contracts with Customers: Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. The Company continues to evaluate the impact that the adoption of these standards will have on its consolidated financial statements in connection with the Roche License Agreement. In February 2016, the FASB issued Accounting Standards Update 2016-02 (ASU 2016-02), Leases (ASC Topic 842), which will require lessees to recognize assets and liabilities for leases with lease terms of more than 12 months. Consistent with current GAAP, the recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee primarily will depend on its classification as a finance or operating lease. However, unlike current GAAP, which requires only capital leases to be recognized on the balance sheet, the new guidance will require both types of leases to be recognized on the balance sheet. ASU 2016-02 is effective for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. The standard requires that entities use a modified retrospective approach for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements. Entities have the option to use certain relief. Full retrospective application is prohibited. Note 7 Commitments and Contingencies provides details on the Company's current lease arrangements. The Company is evaluating the provisions of ASC Topic 842 to determine the impact the adoption of ASU 2016-02 will have on its consolidated financial statements; however, the Company anticipates recognition of additional assets and corresponding liabilities related to leases on its consolidated balance sheets. Additionally, it is possible that the Company will derecognize its build-to-suit asset and liabilities upon adoption pending its final evaluation. In March 2016, the FASB issued Accounting Standards Update 2016-09 (ASU 2016-09), Improvements to Employee Share-Based Payment Accounting, which modifies certain aspects of the accounting for share-based payment transactions, including income taxes, classification of awards and classification in the statement of cash flows. Through December 31, 2016, excess tax benefits or deficiencies from the Company's equity awards were recorded as additional paid-in capital in its Consolidated Balance Sheets. Upon adoption, the Company will record any excess tax benefits or deficiencies from its equity awards in its Condensed Consolidated Statements of Operations in the reporting periods in which stock options are exercised. This guidance also requires excess tax benefits and deficiencies to be presented as an operating activity on the statement of cash flows and allows an entity to make an accounting policy election to either estimate expected forfeitures or to account for them as they occur. The ASU is effective for reporting periods beginning after December 15, 2016, with early adoption permitted. The Company adopted this ASU on January 1, 2017. Pursuant to the adoption of ASU 2016-09, tax attributes previously tracked off balance sheet have been recorded as deferred tax assets, offset by a valuation allowance. In addition, the Company has reversed its non-current tax liability of $98,000 with the offsetting entry recorded to retained earnings pursuant to the adoption of this ASU. Further, the year-to-date excess benefits have been recorded as a discrete benefit to the tax provision. For the six months ended June 30, 2017, the Company recorded excess tax benefits of $3.4 million as part of its income tax provision in the Condensed Consolidated Statements of Operations. The Company's income tax expense will continue to be impacted by fluctuations in stock price between the grant dates and the exercise dates of its option awards. The presentation requirements for cash flows related to excess tax benefits will be applied retrospectively; as such, prior years have been restated. Lastly, the Company elected to continue to estimate the number of forfeitures related to share-based payments, rather than account for forfeitures as they occur. In August 2016, the FASB issued Accounting Standards Update 2016-15 (ASU 2016-15), Statement of Cash Flows - Classification of Certain Cash Receipts and Cash Payments, which clarifies existing guidance related to accounting for cash receipts and cash payments and classification of statement of cash flow. This guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, and early adoption is permitted. The Company does not expect the adoption of ASU 2016-15 to have an impact on its consolidated financial statements. In May 2017, the FASB issued Accounting Standards Update 2017-09 (ASU 2017-09), Compensation - Stock Compensation (Topic 718) - Scope of Modification Accounting, which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. Entities would apply the modification accounting guidance if the value, vesting requirements or classification of a share-based payment award changes. This pronouncement is effective for annual reporting periods beginning after December 15, 2017 but early adoption is permitted. The Company does not expect the adoption of ASU 2017-09 to have an impact on its consolidated financial statements. |
Composition of Certain Balance Sheet Items (Tables) |
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Jun. 30, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Composition of Certain Balance Sheet Items [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Property and Equipment | Property and equipment, net consisted of the following (in thousands):
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Schedule of Other Current Liabilities | Other current liabilities consisted of the following (in thousands):
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Net Loss Per Ordinary Share (Tables) |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Calculation of Basic and Diluted Net Income or Loss Per Ordinary Share | Net loss per ordinary share was determined as follows (in thousands, except per share amounts):
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Ordinary Shares Equivalent Not Included in Diluted Net Loss Per Share | The equivalent ordinary shares not included in diluted net loss per share because their effect would be anti-dilutive are as follows (in thousands):
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Commitments and Contingencies (Tables) |
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Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Operating Lease Commitments | Future minimum payments under the above-described noncancelable operating lease as of June 30, 2017 are as follows (in thousands):
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Schedule of Future Minimum Payments Under Build-to-Suit Lease Obligations | Future minimum payments under build-to-suit lease obligation as of June 30, 2017 are as follows (in thousands):
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Contractual Obligation, Fiscal Year Maturity Schedule | The following is a summary of the Company's non-cancelable purchase commitments and contractual obligations as of June 30, 2017 (in thousands):
(1) Excludes future obligations pursuant to the cost-sharing arrangement under the Company's License Agreement with Roche. Amounts of such obligations, if any, cannot be determined at this time. |
Share-Based Compensation (Tables) |
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Summary of Share-Based Compensation Expense | The following table summarizes share-based compensation expense for the periods presented (in thousands):
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Amended and Restated 2012 Long Term Incentive Plan [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value of Options Granted | The fair value of the options granted to employees and non-employee directors during the three and six months ended June 30, 2017 and 2016 was estimated as of the grant date using the Black-Scholes option-pricing model assuming the weighted-average assumptions listed in the following table:
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Summary of Company's Share Option Activity | The following table summarizes the Company’s stock option activity during the six months ended June 30, 2017:
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Organization - Additional Information (Detail) - USD ($) $ in Thousands |
1 Months Ended | ||
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Mar. 31, 2017 |
Jun. 30, 2017 |
Dec. 31, 2016 |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Accumulated deficit | $ 342,198 | $ 289,211 | |
Cash and cash equivalents | $ 471,729 | $ 386,923 | |
Underwritten Public And Over-Allotment Offering [Member] | |||
Equity [Abstract] | |||
Sale of Stock, Consideration Received on Transaction | $ 150,300 | ||
Underwritten Public And Over-Allotment Offering [Member] | Ordinary Share [Member] | |||
Equity [Abstract] | |||
Sale of Stock, Number of Shares Issued in Transaction | 2,700,000.00 |
Summary of Significant Accounting Policies Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2017 |
Jun. 30, 2017 |
Jan. 01, 2017 |
Dec. 31, 2016 |
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Significant accounting policies [line item] | ||||
Excess tax benefit booked to Income Tax Provision, Amount | $ (1,500) | $ (3,400) | ||
Income taxes payable, non-current | 0 | 0 | $ (98) | |
Accounting Standards Update 2016-09 | ||||
Significant accounting policies [line item] | ||||
Income taxes payable, non-current | $ 98 | |||
Retained Earnings | Accounting Standards Update 2016-09 | ||||
Significant accounting policies [line item] | ||||
Cumulative effect of new accounting principle in period of adoption | $ 98 | |||
UNITED STATES | ||||
Significant accounting policies [line item] | ||||
Long-lived assets | 55,100 | 55,100 | 55,700 | |
IRELAND | ||||
Significant accounting policies [line item] | ||||
Long-lived assets | $ 700 | $ 700 | $ 800 |
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Millions |
Jun. 30, 2017 |
Dec. 31, 2016 |
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Level 1 [Member] | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Money market funds at carrying value | $ 385.9 | $ 307.3 |
Composition of Certain Balance Sheet Items - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands |
Jun. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Composition of Certain Balance Sheet Items [Abstract] | ||
Machinery and equipment | $ 9,020 | $ 9,629 |
Leasehold improvements | 580 | 2,769 |
Purchased computer software | 714 | 363 |
Build-to-Suit Property | 51,760 | 51,359 |
Property and equipment, gross | 62,074 | 64,120 |
Less: accumulated depreciation and amortization | (6,231) | (7,668) |
Property and equipment, net | $ 55,843 | $ 56,452 |
Composition of Certain Balance Sheet Items - Additional Information (Detail) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2017 |
Jun. 30, 2016 |
Jun. 30, 2017 |
Jun. 30, 2016 |
|
Composition of Certain Balance Sheet Items [Abstract] | ||||
Depreciation expense | $ 0.8 | $ 0.4 | $ 1.5 | $ 0.7 |
Composition of Certain Balance Sheet Items - Schedule of Other Current Liabilities (Detail) - USD ($) $ in Thousands |
Jun. 30, 2017 |
Dec. 31, 2016 |
---|---|---|
Composition of Certain Balance Sheet Items [Abstract] | ||
Payroll and related expenses | $ 4,234 | $ 6,629 |
Professional services | 351 | 435 |
Deferred rent | 49 | 363 |
Other | 1,217 | 1,128 |
Other current liabilities | $ 5,851 | $ 8,555 |
Net Loss Per Ordinary Share - Calculation of Basic and Diluted Net Loss Per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2017 |
Jun. 30, 2016 |
Jun. 30, 2017 |
Jun. 30, 2016 |
|
Numerator: | ||||
Net loss | $ (17,701) | $ (40,445) | $ (53,085) | $ (67,966) |
Denominator | ||||
Weighted-average ordinary shares outstanding | 38,073 | 34,358 | 36,922 | 34,192 |
Net loss per share | ||||
Basic and diluted net loss per share (in dollars per share) | $ (0.46) | $ (1.18) | $ (1.44) | $ (1.99) |
Net Loss Per Ordinary Share - Ordinary Shares Equivalent Not Included in Diluted Net Loss Per Share (Detail) - shares shares in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2017 |
Jun. 30, 2016 |
Jun. 30, 2017 |
Jun. 30, 2016 |
|
Options to purchase ordinary shares [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Stock options to purchase ordinary shares not included in diluted net loss per share | 4,608 | 4,121 | 4,608 | 4,121 |
Commitment and Contingencies - Lease Narrative (Details) $ in Thousands, € in Millions |
1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|---|
Mar. 31, 2016 |
Aug. 31, 2015
EUR (€)
ft²
|
Jun. 30, 2017
USD ($)
|
Jun. 30, 2016
USD ($)
|
Jun. 30, 2017
USD ($)
|
Jun. 30, 2016
USD ($)
|
Aug. 31, 2015
USD ($)
|
|
Loss Contingencies [Line Items] | |||||||
Operating Leases, Rent Expense, Net | $ 200 | $ 600 | $ 500 | $ 1,000 | |||
Future minimum payments due | 1,931 | 1,931 | |||||
Dublin, Ireland [Member] | |||||||
Loss Contingencies [Line Items] | |||||||
Operating Leases, Area of office space (in sq ft) | ft² | 6,258 | ||||||
Operating leases, term of contract (in years) | 10 years | ||||||
Operating Leases, Rent review term (in years) | 5 years | ||||||
Operating leases, Option to terminate, date | Aug. 31, 2020 | ||||||
Future minimum payments due | € 2.0 | $ 1,900 | $ 1,900 | $ 2,300 | |||
Built-to-Suit Lease [Member] | |||||||
Loss Contingencies [Line Items] | |||||||
Build-to-suit lease expiration date | Dec. 31, 2023 |
Commitment and Contingencies Commitment and Contingencies - Schedule of Future Lease Payments - Dublin (Details) $ in Thousands |
Jun. 30, 2017
USD ($)
|
---|---|
Operating Lease | |
2017 (6 months) | $ 118 |
2018 | 236 |
2019 | 236 |
2020 | 237 |
2021 | 237 |
Thereafter | 867 |
Total | $ 1,931 |
Commitment and Contingencies - Current SSF Facility (Details) - Built-to-Suit Lease [Member] $ in Thousands |
Jun. 30, 2017
USD ($)
|
---|---|
Build-to-suit Lease [Line Items] | |
2017 (6 months) | $ 2,015 |
2018 | 4,915 |
2019 | 5,803 |
2020 | 5,979 |
2021 | 6,165 |
Thereafter | 12,885 |
Future payments due | $ 37,762 |
Commitment and Contingencies Commitment and Contingencies - Commitment Narrative (Details) $ in Thousands |
Jun. 30, 2017
USD ($)
|
---|---|
Loss Contingencies [Line Items] | |
Purchase obligation | $ 44,872 |
Accrued Liabilities [Member] | |
Loss Contingencies [Line Items] | |
Commitment to suppliers included in accrued liabilities | 12,800 |
Contractual obligations under license agreements included in accrued current liabilities | 300 |
Licensing Agreements [Member] | |
Loss Contingencies [Line Items] | |
Future payments due | $ 1,700 |
Commitment and Contingencies - Contractual Obligations (Details) $ in Thousands |
Jun. 30, 2017
USD ($)
|
---|---|
Purchase Obligations | |
Total | $ 44,872 |
2017 | 22,271 |
2018 | 6,976 |
2019 | 15,593 |
2020 | 32 |
2021 | 0 |
Thereafter | 0 |
Purchase and Contractual Obligations, Fiscal Year Maturity | |
Total | 46,597 |
2017 | 22,676 |
2018 | 7,106 |
2019 | 15,723 |
2020 | 132 |
2021 | 100 |
Thereafter | 860 |
License Agreements [Member] | |
Contractual obligations under license agreements | |
Total | 1,725 |
2017 | 405 |
2018 | 130 |
2019 | 130 |
2020 | 100 |
2021 | 100 |
Thereafter | $ 860 |
Roche License Agreement (Details) - Roche [Member] - USD ($) $ in Millions |
1 Months Ended | 3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|---|
Jun. 30, 2017 |
Jun. 30, 2017 |
Jun. 30, 2016 |
Jun. 30, 2017 |
Jun. 30, 2016 |
|
License Agreement [Line Items] | |||||
Milestone Receivable, Clinical Milestone | $ 30.0 | ||||
Collaboration Revenue, Clinical Milestone | $ 26.6 | $ 26.6 | |||
Milestone Method, Portion of Milestone Amount used to Offset R&D Expense | 3.4 | 3.4 | |||
Collaborative Arrangement [Member] | |||||
License Agreement [Line Items] | |||||
Cost sharing payments recognized as research and development expense | 2.9 | $ 0.9 | 4.2 | $ 1.4 | |
Research Reimbursement [Member] | |||||
License Agreement [Line Items] | |||||
Collaboration service revenue, research services | 0.2 | 0.3 | 0.5 | 0.6 | |
Development Costs Reimbursement [Member] | |||||
License Agreement [Line Items] | |||||
Development Reimbursement Recognized As Offset To Research And Development Expense | $ 0.4 | $ 0.7 | $ 1.2 | $ 1.9 |
Share-Based Compensation - Summary of Share-Based Compensation Expense (Detail) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2017 |
Jun. 30, 2016 |
Jun. 30, 2017 |
Jun. 30, 2016 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 6,653 | $ 4,546 | $ 12,255 | $ 8,270 |
Research and development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | 2,735 | 1,818 | 5,043 | 3,237 |
General and administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 3,918 | $ 2,728 | $ 7,212 | $ 5,033 |
Share-Based Compensation - Fair Value of Options Granted (Detail) - Amended and Restated 2012 Long Term Incentive Plan [Member] - $ / shares |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2017 |
Jun. 30, 2016 |
Jun. 30, 2017 |
Jun. 30, 2016 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility | 72.20% | 75.60% | 72.80% | 74.90% |
Risk-free interest rate | 2.00% | 1.50% | 2.00% | 1.40% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Expected life (in years) | 6 years | 6 years | 6 years | 6 years |
Weighted average grant date fair value | $ 35.37 | $ 28.72 | $ 35.32 | $ 23.52 |
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|
Jun. 30, 2017 |
Jun. 30, 2016 |
Jun. 30, 2017 |
Jun. 30, 2016 |
Jan. 01, 2017 |
Dec. 31, 2016 |
|
Income Taxes [Line Items] | ||||||
Income tax expense (benefit) | $ (1,287) | $ 189 | $ (2,948) | $ 370 | ||
Excess tax benefit booked to Income Tax Provision, Amount | (1,500) | (3,400) | ||||
Income taxes payable, non-current | $ 0 | $ 0 | $ (98) | |||
Accounting Standards Update 2016-09 | ||||||
Income Taxes [Line Items] | ||||||
Income taxes payable, non-current | $ 98 | |||||
Accounting Standards Update 2016-09 | Retained Earnings | ||||||
Income Taxes [Line Items] | ||||||
Cumulative effect of new accounting principle in period of adoption | $ 98 | |||||
Revenue Commissioners, Ireland | ||||||
Income Taxes [Line Items] | ||||||
Ireland statutory tax rate, percent | 12.50% | 12.50% |
Related Parties (Details) - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2017 |
Jun. 30, 2016 |
Jun. 30, 2017 |
Jun. 30, 2016 |
|
Chief Regulatory Officer [Member] | ||||
Related Party Transaction [Line Items] | ||||
Consulting payments | $ 0 | $ 68,600 | $ 0 | $ 68,600 |
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