ý | 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 | ý | Accelerated filer | o |
Non-accelerated filer | o(Do not check if a smaller reporting company) | Smaller reporting company | o |
Page | |
Condensed Consolidated Balance Sheets as of June 30, 2016 and December 31, 2015 | |
Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2016 and 2015 | |
Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2016 and 2015 | |
June 30, | December 31, | ||||||
2016 | 2015 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 442,948 | $ | 370,586 | |||
Receivable from Roche | 364 | 509 | |||||
Prepaid expenses and other current assets | 7,286 | 6,308 | |||||
Total current assets | 450,598 | 377,403 | |||||
Non-current assets: | |||||||
Property and equipment, net | 41,852 | 3,862 | |||||
Deferred tax assets | 3,693 | 2,850 | |||||
Restricted cash | 4,056 | — | |||||
Other non-current assets | 2,363 | 1,121 | |||||
Total non-current assets | 51,964 | 7,833 | |||||
Total assets | $ | 502,562 | $ | 385,236 | |||
Liabilities and Shareholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 11,592 | $ | 4,519 | |||
Accrued research and development | 16,650 | 12,794 | |||||
Other current liabilities | 5,214 | 4,903 | |||||
Total current liabilities | 33,456 | 22,216 | |||||
Non-current liabilities: | |||||||
Income taxes payable, non-current | 98 | 98 | |||||
Deferred rent | 2,084 | 2,127 | |||||
Build-to-suit lease obligation, non-current | 35,933 | — | |||||
Other liabilities | 126 | 126 | |||||
Total non-current liabilities | 38,241 | 2,351 | |||||
Total liabilities | 71,697 | 24,567 | |||||
Commitments and contingencies (Note 6) | |||||||
Shareholders’ equity: | |||||||
Euro deferred shares, €22 nominal value: | — | — | |||||
Authorized shares — 10,000 at June 30, 2016 and December 31, 2015 | |||||||
Issued and outstanding shares — none at June 30, 2016 and December 31, 2015 | |||||||
Ordinary shares, $0.01 par value: | 343 | 317 | |||||
Authorized shares — 100,000,000 at June 30, 2016 and December 31, 2015 | |||||||
Issued and outstanding shares — 34,381,501 and 31,744,102 at June 30, 2016 and December 31, 2015, respectively | |||||||
Additional paid-in capital | 627,591 | 489,455 | |||||
Accumulated deficit | (197,069 | ) | (129,103 | ) | |||
Total shareholders’ equity | 430,865 | 360,669 | |||||
Total liabilities and shareholders’ equity | $ | 502,562 | $ | 385,236 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
Collaboration revenue | 333 | 278 | $ | 598 | $ | 871 | ||||||||||
Total revenue | 333 | 278 | 598 | 871 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 32,359 | 12,791 | 52,852 | 23,364 | ||||||||||||
General and administrative | 8,134 | 5,522 | 15,316 | 10,571 | ||||||||||||
Total operating expenses | 40,493 | 18,313 | 68,168 | 33,935 | ||||||||||||
Loss from operations | (40,160 | ) | (18,035 | ) | (67,570 | ) | (33,064 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income (expense), net | (10 | ) | 40 | 267 | 66 | |||||||||||
Other expense, net | (86 | ) | (87 | ) | (293 | ) | (20 | ) | ||||||||
Total other income (expense) | (96 | ) | (47 | ) | (26 | ) | 46 | |||||||||
Loss before income taxes | (40,256 | ) | (18,082 | ) | (67,596 | ) | (33,018 | ) | ||||||||
Provision for income taxes | 189 | 195 | 370 | 461 | ||||||||||||
Net loss | $ | (40,445 | ) | $ | (18,277 | ) | $ | (67,966 | ) | $ | (33,479 | ) | ||||
Basic and diluted net loss per share | $ | (1.18 | ) | $ | (0.59 | ) | $ | (1.99 | ) | $ | (1.15 | ) | ||||
Shares used to compute basic and diluted net loss per share | 34,358 | 30,792 | 34,192 | 29,106 |
Six Months Ended June 30, | |||||||
2016 | 2015 | ||||||
Operating activities | |||||||
Net loss | $ | (67,966 | ) | $ | (33,479 | ) | |
Adjustments to reconcile net loss to cash used in operating activities: | |||||||
Depreciation and amortization | 679 | 388 | |||||
Share-based compensation | 8,270 | 4,119 | |||||
Excess tax benefit from share-based award exercises | (300 | ) | (989 | ) | |||
Deferred income taxes | (854 | ) | (426 | ) | |||
Interest expense under build-to-suit lease transaction | 325 | — | |||||
Loss on sublease | — | 261 | |||||
Changes in operating assets and liabilities: | |||||||
Receivable from Roche | 145 | 768 | |||||
Receivable from related party | — | 30 | |||||
Other assets | (2,331 | ) | 1,560 | ||||
Accounts payable, accruals and other liabilities | 9,349 | 1,908 | |||||
Net cash used in operating activities | (52,683 | ) | (25,860 | ) | |||
Investing activities | |||||||
Purchases of property and equipment | (942 | ) | (68 | ) | |||
Change in restricted cash | (4,056 | ) | — | ||||
Net cash used in investing activities | (4,998 | ) | (68 | ) | |||
Financing activities | |||||||
Proceeds from issuance of ordinary shares in public offering, net | 128,777 | 131,481 | |||||
Proceeds from issuance of ordinary shares upon exercise of stock options | 966 | 2,268 | |||||
Excess tax benefit from share-based award exercises | 300 | 989 | |||||
Net cash provided by financing activities | 130,043 | 134,738 | |||||
Net increase in cash and cash equivalents | 72,362 | 108,810 | |||||
Cash and cash equivalents, beginning of the year | 370,586 | 293,579 | |||||
Cash and cash equivalents, end of the period | $ | 442,948 | $ | 402,389 | |||
Supplemental disclosures of cash flow information | |||||||
Cash paid for income taxes, net of refunds | $ | 877 | $ | 442 | |||
Supplemental disclosures of non-cash investing and financing activities | |||||||
Acquisition of property and equipment included in accounts payable and accrued liabilities | $ | 16 | $ | 15 | |||
Amounts capitalized under build-to-suit lease transaction | $ | 37,571 | $ | — | |||
Interest capitalized during construction period for build-to-suit lease transaction | $ | 326 | $ | — | |||
Stock option shortfall | $ | (11 | ) | $ | — | ||
Offering costs included in accounts payable and accrued liabilities | $ | — | $ | 41 |
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, | December 31, | ||||||
2016 | 2015 | ||||||
Machinery and equipment | $ | 6,323 | $ | 6,210 | |||
Leasehold improvements | 2,764 | 2,828 | |||||
Purchased computer software | 225 | 167 | |||||
Construction-in-progress build-to-suit | 38,554 | — | |||||
47,866 | 9,205 | ||||||
Less: accumulated depreciation and amortization | (6,014 | ) | (5,343 | ) | |||
Property and equipment, net | $ | 41,852 | $ | 3,862 |
June 30, | December 31, | ||||||
2016 | 2015 | ||||||
Payroll and related expenses | $ | 3,035 | $ | 3,774 | |||
Professional services | 615 | 325 | |||||
Deferred rent | 320 | 284 | |||||
Other | 1,244 | 520 | |||||
Other current liabilities | $ | 5,214 | $ | 4,903 |
5. | Net income (loss) Per Ordinary Share |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Numerator: | |||||||||||||||
Net loss | $ | (40,445 | ) | $ | (18,277 | ) | $ | (67,966 | ) | $ | (33,479 | ) | |||
Denominator: | |||||||||||||||
Weighted-average ordinary shares outstanding | 34,358 | 30,792 | 34,192 | 29,106 | |||||||||||
Net loss per share: | |||||||||||||||
Basic and diluted net loss per share | $ | (1.18 | ) | $ | (0.59 | ) | $ | (1.99 | ) | $ | (1.15 | ) |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||
Stock options to purchase ordinary shares | 4,121 | 3,290 | 4,121 | 3,290 |
Year Ended December 31, | Operating Lease | Sublease Rental | ||||||
2016 (six months) | $ | 1,090 | $ | (261 | ) | |||
2017 | 2,246 | (316 | ) | |||||
2018 | 2,326 | — | ||||||
2019 | 2,410 | — | ||||||
2020 | 2,287 | — | ||||||
Thereafter | 1,073 | — | ||||||
Total | $ | 11,432 | $ | (577 | ) |
Year Ended December 31, | Expected Cash Payments Under Build-To-Suit Lease Obligation | |||
2016 (six months) | $ | — | ||
2017 | 3,275 | |||
2018 | 4,915 | |||
2019 | 5,803 | |||
2020 | 5,979 | |||
Thereafter | 19,050 | |||
Total | $ | 39,022 |
Total | 2016 | 2017 | 2018 | 2019 | 2020 | Thereafter | |||||||||||||||
Purchase Obligations | $ | 17,181 | $ | 16,980 | $ | 86 | $ | 53 | $ | 30 | $ | 32 | $ | — | |||||||
Contractual obligations under license agreements (1) | 1,390 | 140 | 120 | 120 | 120 | 90 | 800 | ||||||||||||||
Total | $ | 18,571 | $ | 17,120 | $ | 206 | $ | 173 | $ | 150 | $ | 122 | $ | 800 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Research and development(1) | 1,818 | $ | 969 | $ | 3,237 | $ | 1,727 | ||||||||
General and administrative | 2,728 | 1,447 | 5,033 | 2,392 | |||||||||||
Total share-based compensation expense | $ | 4,546 | $ | 2,416 | $ | 8,270 | $ | 4,119 |
(1) | Includes $nil and $nil for the three months ended June 30, 2016 and 2015, respectively, and $nil and $42,000 for the six months ended June 30, 2016 and 2015, respectively, of share-based compensation expense related to options granted to a consultant. |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
2016 | 2015 | 2016 | 2015 | ||||
Expected volatility | 75.6% | 75.3% | 74.9% | 76.1% | |||
Risk-free interest rate | 1.5% | 1.8% | 1.4% | 1.8% | |||
Expected dividend yield | —% | —% | —% | —% | |||
Expected life (in years) | 6.0 | 6.0 | 6.0 | 6.0 | |||
Weighted average grant date fair value | $28.72 | $25.50 | $23.52 | $19.54 |
Options | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (years) | Aggregate Intrinsic Value (in thousands) | |||||||||
Outstanding at December 31, 2015 | 3,142,364 | $ | 21.36 | 8.14 | $ | 146,917 | ||||||
Granted | 1,120,475 | 35.87 | ||||||||||
Exercised | (49,899 | ) | 19.39 | |||||||||
Canceled | (91,617 | ) | 41.69 | |||||||||
Outstanding at June 30, 2016 | 4,121,323 | $ | 24.87 | 8.17 | $ | 47,332 | ||||||
Vested and expected to vest at June 30, 2016 | 3,534,399 | $ | 23.39 | 8.01 | $ | 45,366 | ||||||
Vested at June 30, 2016 | 1,732,399 | $ | 15.38 | 7.23 | $ | 34,185 |
• | 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; |
• | Expected lease term- Our expected lease term includes the contractual lease period. The expected lease term is used in determining the depreciable life of the asset or the straight-line rent recognition period for the portion of the lease payment allocable to the land component. |
• | Incremental borrowing rate- We estimate our incremental borrowing rate. For build-to-suit leases recorded on our consolidated balance sheet with a related build-to-suit lease obligation, the incremental borrowing rate is used in allocating our rental payments between interest expense and a reduction of the outstanding build-to-suit lease obligation. |
• | Fair market value of leased asset- The fair market value of a build-to-suit lease property is based on replacement cost of the pre-construction shell and comparable market data. Fair market value is used in determining the amount of the property asset and related build-to-suit lease obligation to be recognized on our consolidated balance sheet for build-to-suit leases. |
Three Months Ended June 30, | Percentage Change | |||||||||
2016 | 2015 | |||||||||
(Dollars in thousands) | ||||||||||
Collaboration revenue | $ | 333 | $ | 278 | 20 | % | ||||
Total revenue | $ | 333 | $ | 278 | 20 | % |
Six Months Ended June 30, | Percentage Change | |||||||||
2016 | 2015 | |||||||||
(Dollars in thousands) | ||||||||||
Collaboration revenue | $ | 598 | $ | 871 | (31 | )% | ||||
Total revenue | $ | 598 | $ | 871 | (31 | )% |
Three Months Ended June 30, | Percentage Change | ||||||||
2016 | 2015 | ||||||||
(Dollars in thousands) | |||||||||
Research and development | $ | 32,359 | 12,791 | 153 | % | ||||
General and administrative | 8,134 | 5,522 | 47 | % | |||||
Total operating expenses | $ | 40,493 | 18,313 | 121 | % |
Six Months Ended June 30, | Percentage Change | |||||||||
2016 | 2015 | |||||||||
(Dollars in thousands) | ||||||||||
Research and development | $ | 52,852 | $ | 23,364 | 126 | % | ||||
General and administrative | 15,316 | 10,571 | 45 | % | ||||||
Total operating expenses | $ | 68,168 | $ | 33,935 | 101 | % |
Three Months Ended June 30, | Six Months Ended June 30, | Cumulative to Date | ||||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||||
NEOD001 (1) | $ | 22,377 | $ | 7,367 | $ | 35,613 | $ | 12,315 | $ | 104,924 | ||||||||||
PRX002 (2) | $ | 1,797 | $ | 1,824 | 3,192 | 3,777 | 40,974 | |||||||||||||
PRX003 (3) | 2,637 | 1,890 | 5,067 | 3,768 | 39,372 | |||||||||||||||
Other R&D (4) | 5,548 | 1,710 | 8,980 | 3,504 | ||||||||||||||||
$ | 32,359 | $ | 12,791 | $ | 52,852 | $ | 23,364 |
(1) | Cumulative R&D costs to date for NEOD001 include the costs incurred from the date when the program has been separately tracked in preclinical 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 preclinical 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, 2016, $0.7 million and $1.9 million, respectively, and $1.5 million and $2.7 million for the three and six months ended June 30, 2015, 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 preclinical 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 preclinical 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 | |||||||||
2016 | 2015 | |||||||||
(Dollars in thousands) | ||||||||||
Interest income (expense), net | $ | (10 | ) | $ | 40 | (125 | )% | |||
Other expense, net | (86 | ) | (87 | ) | (1 | )% | ||||
Total Other Income (Expense) | (96 | ) | (47 | ) | 104 | % |
Six Months Ended June 30, | Percentage Change | |||||||||
2016 | 2015 | |||||||||
(Dollars in thousands) | ||||||||||
Interest income (expense), net | $ | 267 | $ | 66 | 305 | % | ||||
Other expense, net | (293 | ) | (20 | ) | 1,365 | % | ||||
Total Other Income (Expense) | $ | (26 | ) | $ | 46 | (157 | )% |
Three Months Ended June 30, | Percentage Change | |||||||
2016 | 2015 | |||||||
(Dollars in thousands) | ||||||||
Provision for income taxes | 189 | 195 | (3 | )% |
Six Months Ended June 30, | Percentage Change | |||||||||
2016 | 2015 | |||||||||
(Dollars in thousands) | ||||||||||
Provision for income taxes | $ | 370 | $ | 461 | (20 | )% |
June 30, | December 31, | ||||||
2016 | 2015 | ||||||
Working capital | $ | 417,142 | $ | 355,187 | |||
Cash and cash equivalents | 442,948 | 370,586 | |||||
Total assets | 502,562 | 385,236 | |||||
Total liabilities | 71,697 | 24,567 | |||||
Total shareholders’ equity | 430,865 | 360,669 |
Six Months Ended June 30, | |||||||
2016 | 2015 | ||||||
Net cash used in operating activities | $ | (52,683 | ) | $ | (25,860 | ) | |
Net cash used in investing activities | (4,998 | ) | (68 | ) | |||
Net cash provided by financing activities | 130,043 | 134,738 | |||||
Net increase in cash and cash equivalents | $ | 72,362 | $ | 108,810 |
Total | 2016 | 2017 | 2018 | 2019 | 2020 | Thereafter | |||||||||||||||
Operating leases (1) | $ | 11,432 | $ | 1,090 | $ | 2,246 | $ | 2,326 | $ | 2,410 | $ | 2,287 | $ | 1,073 | |||||||
Minimum cash payments under build-to-suit lease obligation (1) | 39,022 | — | 3,275 | 4,915 | 5,803 | 5,979 | 19,050 | ||||||||||||||
Purchase obligations | 17,181 | 16,980 | 86 | 53 | 30 | 32 | — | ||||||||||||||
Contractual obligations under license agreements (2) | 1,390 | 140 | 120 | 120 | 120 | 90 | 800 | ||||||||||||||
Total | $ | 69,025 | $ | 18,210 | $ | 5,727 | $ | 7,414 | $ | 8,363 | $ | 8,388 | $ | 20,923 |
• | conduct our Phase 3, Phase 2b, Phase 1/2 and open label extension ("OLE") clinical trials for NEOD001, conduct our Phase 1b clinical trial for PRX002, 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, PRX003 and PRX004; |
• | complete preclinical development of other product candidates and initiate clinical trials, if supported by positive preclinical 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, Phase 1/2 and OLE clinical trials for NEOD001, our Phase 1b clinical trial for PRX002, and our Phase 1b clinical trial for PRX003; |
• | the timing, initiation, progress, results and costs of these and our other research, development and commercialization activities, including in connection with PRX002 under our License Agreement with Roche; |
• | the results of our research and preclinical 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 foreign 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 patients 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; |
• | varying 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; |
• | unforeseen safety issues; or |
• | lack of adequate funding to continue the clinical trial. |
• | the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; |
• | we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign 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 foreign 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 foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; |
• | the data collected from clinical trials of our drug candidates may not be sufficient to support the submission of a Biologics License Application ("BLA") or other submission or to obtain regulatory approval in the U.S. or elsewhere; |
• | the FDA or comparable foreign 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 foreign 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 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 False Claims Act and the 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 income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability; |
• | 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 preclinical 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 federal 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 federal 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 federal 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 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 foreign 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 foreign laws that require pharmaceutical companies to comply |
• | 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, as well as any future Licensed Products targeting α-synuclein; |
• | failure or delays in advancing our preclinical 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 foreign 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 2, 2016 | Prothena Corporation plc (Registrant) | ||
/s/ Dale B. Schenk | ||||
Dale B. Schenk | ||||
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 | |||
3.1 | Amended and Restated Memorandum and Articles of Association of Prothena Corporation plc | 8-K | 001-35676 | 5/25/2016 | 3.1 | ||||
10.1# | Prothena Corporation plc Amended and Restated 2012 Long Term Incentive Plan (as of May 19, 2016) | 8-K | 001-35676 | 5/25/2016 | 10.1 | ||||
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. |
* | 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. |
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 2, 2016 | /s/ Dale B. Schenk |
Dale B. Schenk | ||
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 2, 2016 | /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, 2016, 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 2, 2016 | /s/ Dale B. Schenk |
Dale B. Schenk | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) | ||
/s/ Tran B. Nguyen | ||
Tran B. Nguyen | ||
Chief Financial Officer | ||
(Principal Financial Officer) | ||
Document and Entity Information - shares |
6 Months Ended | |
---|---|---|
Jun. 30, 2016 |
Jul. 22, 2016 |
|
Document Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2016 | |
Document Fiscal Year Focus | 2016 | |
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 | 34,395,876 |
Condensed Consolidated Balance Sheets (Parenthetical) |
Jun. 30, 2016
$ / shares
shares
|
Jun. 30, 2016
€ / shares
shares
|
Dec. 31, 2015
$ / shares
shares
|
Dec. 31, 2015
€ / 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 | 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 | 0 | 0 | 0 | 0 |
Ordinary shares, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | ||
Ordinary shares, number of authorized shares | 100,000,000 | 100,000,000 | 100,000,000 | 100,000,000 |
Ordinary shares, number of issued shares | 34,381,501 | 34,381,501 | 31,744,102 | 31,744,102 |
Ordinary shares, number of outstanding shares | 34,381,501 | 34,381,501 | 31,744,102 | 31,744,102 |
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2016 |
Jun. 30, 2015 |
Jun. 30, 2016 |
Jun. 30, 2015 |
|
Income Statement [Abstract] | ||||
Collaboration revenue | $ 333,000 | $ 278,000 | $ 598,000 | $ 871,000 |
Total revenue | 333,000 | 278,000 | 598,000 | 871,000 |
Operating expenses: | ||||
Research and development | 32,359,000 | 12,791,000 | 52,852,000 | 23,364,000 |
General and administrative | 8,134,000 | 5,522,000 | 15,316,000 | 10,571,000 |
Total operating expenses | 40,493,000 | 18,313,000 | 68,168,000 | 33,935,000 |
Loss from operations | (40,160,000) | (18,035,000) | (67,570,000) | (33,064,000) |
Other income (expense): | ||||
Interest income (expense), net | (10,000) | 40,000 | 267,000 | 66,000 |
Other expense, net | (86,000) | (87,000) | (293,000) | (20,000) |
Total other income (expense) | (96,000) | (47,000) | (26,000) | 46,000 |
Loss before income taxes | (40,256,000) | (18,082,000) | (67,596,000) | (33,018,000) |
Provision for income taxes | 189,000 | 195,000 | 370,000 | 461,000 |
Net loss | $ (40,445,000) | $ (18,277,000) | $ (67,966,000) | $ (33,479,000) |
Basic and diluted net loss per share (in dollars per share) | $ (1.18) | $ (0.59) | $ (1.99) | $ (1.15) |
Shares used to compute basic and diluted net loss per share (in shares) | 34,358 | 30,792 | 34,192 | 29,106 |
Organization |
6 Months Ended |
---|---|
Jun. 30, 2016 | |
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 seeking to fundamentally change the course of progressive diseases, with its clinical pipeline of novel therapeutic antibodies. 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), inflammatory diseases including psoriasis (PRX003) and TTR amyloidosis (PRX004). 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, 2016, the Company had an accumulated deficit of $197.1 million and cash and cash equivalents of $442.9 million. Based on the Company's business plans, management believes that the Company's cash and cash equivalents at June 30, 2016 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, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Preparation and Presentation of Financial Information These accompanying 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 Regulations 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 (“SEC”) on February 25, 2016 (the "2015 Form 10-K"). These Condensed Consolidated Financial Statements are presented in U.S. dollars, which is the functional currency of the Company and its consolidated subsidiaries. These unaudited 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 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 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. 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, 2016, from the significant accounting policies described in Note 2 of the "Notes to Consolidated Financial Statements" in the 2015 Form 10-K, with the exception of those noted below. Restricted Cash Cash accounts that are restricted to withdrawal or usage are presented as restricted cash. As of June 30, 2016 , the Company had $4.1 million of restricted cash held by a bank in a certificate of deposit as collateral to a standby letter of credit under a build-to-suit lease. See Note 6 to the Condensed Consolidated Financial Statements regarding “Build-to-Suit Lease Accounting” for more information. Build-to-Suit Leases In certain lease arrangements, the Company is involved in the construction of the building. To the extent the Company is involved with the structural improvements of the construction project or takes construction risk prior to the commencement of a lease, ASC 840-40, “Leases – Sale-Leaseback Transactions (Subsection 05-5),” requires the Company to be considered the owner for accounting purposes of these types of projects during the construction period. Therefore, the Company records an asset in property and equipment, net on the consolidated balance sheets, including capitalized interest costs, for the replacement cost of the pre-existing building plus the amount of estimated construction costs and tenant improvements incurred by the landlord and the Company as of the balance sheet date. The Company records a corresponding build-to-suit lease obligation on its consolidated balance sheets representing the amounts paid by the lessor. Once construction is complete, the Company considers the requirements for sale-leaseback accounting treatment, including evaluating whether all risks of ownership have been transferred back to the landlord, as evidenced by a lack of continuing involvement in the leased property. If the arrangement does not qualify for sale-leaseback accounting treatment, the building asset remains on the Company’s consolidated balance sheets at its historical cost, and such asset is depreciated over its estimated useful life. The Company bifurcates its lease payments into a portion allocated to the building and a portion allocated to the parcel of land on which the building has been built. The portion of the lease payments allocated to the land is treated for accounting purposes as operating lease payments, and therefore is recorded as rent expense in the consolidated statements of operations. The portion of the lease payments allocated to the building is further bifurcated into a portion allocated to interest expense and a portion allocated to reduce the build-to-suit lease obligation. The interest rate used for the build-to-suit lease obligation represents the Company’s estimated incremental borrowing rate at inception of the lease, adjusted to reduce any built in loss. The initial recording of these assets and liabilities is classified as non-cash investing and financing items, respectively, for purposes of the consolidated statements of cash flows. 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 consolidated balance sheet. Receivable from Roche as of June 30, 2016 and December 31, 2015 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 of amounts recorded on the Company's Consolidated Balance Sheet. As of June 30, 2016, $41.0 million of the Company's long-lived assets were held in the U.S. and $0.8 million were held in Ireland. The Company does not own or operate facilities for the manufacture, storage, testing or distribution of preclinical or clinical supplies of any of its drug candidates. The Company instead contracted with and relies on third-parties to manufacture, store, test and distribute all preclinical development and clinical supplies of its drug candidates, and the Company plans to continue to do so for the foreseeable future. Currently, the Company has a single source of preclinical or clinical supplies for each of its drug candidates. A delay or inability to obtain such supply could have an adverse effect on the Company's business, financial condition and results of operations. 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), and requires entities to recognize revenue in a way that depicts the transfer of promised goods and services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. 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 permits the use of either retrospective or cumulative effect transition method. The Company is currently evaluating the potential impact the adoption of ASU 2014-09 will have on its consolidated financial statements. The Company has not yet selected a transition method nor has it determined the effect of the standard on its ongoing financial reporting. 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. The Company is evaluating the potential impact the adoption of ASU 2016-02 will have on its consolidated financial statements. In March 2016, the FASB issued Accounting Standards Update 2016-09 (ASU 2016-09), Improvements to Employee Share-Based Payment Accounting. Under the new guidance, APIC pools will be eliminated and entities will be required to recognize the income tax effects of share-based awards in the income statement when share-based awards vest or are settled. ASU 2016-09 also changes the classification of excess tax benefits on the statement of cash flows. It also will allow an employer to repurchase more of an employee's shares than it can currently for tax withholding purposes without triggering liability accounting and to make a policy election to either account for forfeitures as they occur or to continue the current practice of estimating forfeitures at the time of grant. ASU 2016-09 is effective prospectively for fiscal years beginning after December 15, 2016, and interim periods within those years. Early adoption is permitted, but all of the guidance must be adopted in the same period. The Company is evaluating the impact the adoption of ASU 2016-09 will have on its consolidated financial statements. |
Fair Value Measurements |
6 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2016 | |||||||||
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 $400.9 million and $320.5 million in money market funds included in cash and cash equivalents at June 30, 2016 and December 31, 2015, 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 $0.4 million and $0.7 million for the three and six months ended June 30, 2016, respectively, compared to $0.2 million and $0.4 million for the three and six months ended June 30, 2015, 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, 2016 and 2015, and therefore diluted net loss per share is equal to basic net loss per share. Net income (loss) per ordinary share was determined as follows (in thousands, except per share amounts):
The equivalent ordinary shares not included in diluted net income (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, 2016 | |
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 “New Facility”). The Lease became effective on March 28, 2016. Subsequently, in April 2016, the Company took possession of the New 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 Lease provides that the Company's obligation to pay rent shall commence on the earlier of (i) the date that certain improvements to the New Facility are completed and (ii) 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. In connection with this Lease, the Company is entitled to a tenant improvement allowance of up to $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 New Facility. The Company is obligated to fund all costs incurred in excess of the tenant improvement allowance. The scope of the planned tenant improvements do not qualify as “normal tenant improvements” under the lease accounting guidance. Accordingly, for accounting purposes, we have concluded the Company is the deemed owner of the building during the construction period. In connection with the Company’s accounting for this transaction, the Company capitalized $35.6 million within property and equipment, net, including $0.3 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, 2016. The Company has also recognized structural tenant improvements totaling $2.9 million for amounts incurred by the Company during the construction period through June 30, 2016, which are expected be reimbursed by the landlord through the tenant improvement allowance. The Company will increase the asset and financing obligation as additional building costs are incurred during the construction period. For the three and six months ended June 30, 2016, we recorded rent expense associated with the ground lease of $0.1 million in the condensed consolidated statements of operations. 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. |
Commitment and Contingencies |
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Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitment and Contingencies | Commitments and Contingencies Lease Commitments The Company currently leases 50,400 square feet of office and research and development space located South San Francisco, California (the “Current Facility”), which lease expires on November 30, 2020. The operating lease for the Current Facility has an estimated annual rent payment of approximately $2.1 million. In December 2014, the Company entered into a noncancelable operating sublease (the "Sublease") with a third party to sublease a portion of its Current Facility to that party. This Sublease has a three-year term which commenced in January 2015 (with options to extend for another year). The Company recognized a loss of $0.4 million in the three months ended March 31, 2015 for the cash difference between the total payments associated with the Sublease, including executory costs, and the amount of Sublease rental receipts over the Sublease term. The Company expects to receive future minimum payments from this Sublease of $0.3 million and $0.3 million in 2016 and 2017, respectively, which is an offset to the lease payments below. 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 $2.2 million as converted using exchange rate as of June 30, 2016, over the term of the lease, assuming current lease payments. Of this obligation, approximately $2.1 million remain outstanding as of June 30, 2016. Future minimum payments under noncancelable operating leases and future minimum rentals to be received under the Sublease as of June 30, 2016, are as follows (in thousands):
The Company recognizes rent expense 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 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. The Company records payments received from the Sublease as offset against the current period rent expense. In June 2016, in connection with the Company's intent to vacate the Current Facility in December 2016, the Company accelerated depreciation related to the leasehold improvements and certain assets that are expected to remain at the Current Facility. The incremental depreciation associated with acceleration of the useful life was $0.2 million of the three and six months ended June 30, 2016. In March 2016, the Company entered into a noncancelable operating sublease in South San Francisco, California (the “New Facility”). The Company is considered the "accounting owner" of the New Facility as a build-to-suit property and has recorded a build-to-suit lease obligation on its 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, 2016, are as follows (in thousands):
Other Commitments 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, 2016, the Company had non-cancelable purchase commitments to suppliers for $17.2 million of which $11.5 million is included in accrued current liabilities, and contractual obligations under license agreements of $1.4 million of which $0.1 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, 2016 (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, 2016 | |
Collaborative Agreement [Abstract] | |
Roche License Agreements | Roche License Agreement 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 $0.3 million and $0.6 million as collaboration revenue for research reimbursement from Roche for the three and six months ended June 30, 2016, respectively, as compared to $0.3 million and $0.6 million for the three and six months ended June 30, 2015, respectively. Cost sharing payments to Roche are recorded as R&D expenses. The Company recognized $0.9 million and $1.4 million in R&D expenses for payments made to Roche during the three and six months ended June 30, 2016, respectively, as compared to $0.8 million and $1.3 million for the three and six months ended June 30, 2015, respectively. Reimbursement for development costs from Roche under the cost-sharing arrangement were allocated between license revenue and an offset to R&D expenses based on the relative selling price method until the full allocated consideration of $35.6 million was recognized as license revenue, after which the full reimbursement is recorded as an offset to R&D expenses. In the year ended December 31, 2015, the Company reached the full allocated consideration of $35.6 million recognized as license revenue; accordingly, future development revenue will be recorded as an offset to R&D expenses. Reimbursement for development costs from Roche during the three and six months ended June 30, 2016 were $0.7 million and $1.9 million, respectively, of which $nil and $nil, was recognized as collaboration license revenue and $0.7 million and $1.9 million, respectively, were recognized as an offset to R&D expenses. Reimbursement for development costs from Roche during the three and six months ended June 30, 2015 were $1.5 million and $3.0 million, respectively, of which $nil and $0.2 million, respectively, were recognized as collaboration license revenue and $1.5 million and $2.7 million, respectively, were recognized as an offset to R&D expenses. The License Agreement provides that Roche would make an upfront payment to the Company of $30.0 million, which was received in February 2014, and the clinical milestone payment of $15.0 million triggered by the initiation of the Phase 1 study for PRX002 in the clinic, which was received in May 2014. The Company recognized the $30.0 million upfront payment from Roche as collaboration license revenue in 2014 and concluded that the $15.0 million clinical milestone is consistent with the definition of a substantive milestone included in 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 recognized payments related to the achievement of this milestone when the milestone was achieved. The milestone payment was allocated to the units of accounting based on the relative selling price method for income statement classification purposes. The Company did not achieve any of the clinical and regulatory milestones under the License Agreement during the six months ended June 30, 2016 and 2015. |
Shareholders' Equity |
6 Months Ended |
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Jun. 30, 2016 | |
Equity [Abstract] | |
Shareholders' Equity | Shareholders' Equity Ordinary Shares As of June 30, 2016, the Company had 100,000,000 ordinary shares authorized for issuance with a par value of $0.01 per ordinary share and 34,381,501 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, 2016, 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, 2016. 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. January 2016 Offering In January 2016, the Company completed an underwritten public offering of an aggregate of 2,587,500 of its ordinary shares at a public offering price of $53.00 per ordinary share. The Company received aggregate net proceeds of approximately $128.6 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 112,000 and 1,120,475 share options during the three and six months ended June 30, 2016, respectively, and 140,000 and 925,550 share options during the three and six months ended June 30, 2015, respectively, under the LTIP. The Company's option awards generally vest over four years. In May 2016, the Company's shareholders approved an increase of 1,850,000 additional ordinary shares authorized for issuance under the LTIP. The aggregate number of ordinary shares authorized for issuance under the LTIP is 7,400,000 ordinary shares, and as of June 30, 2016, 2,598,437 ordinary shares remain available for grant and options to purchase 4,121,323 ordinary shares granted from the LTIP were outstanding with a weighted-average exercise price of approximately $24.87 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 2019 related to unvested share-based payment awards at June 30, 2016 is $46.7 million. The weighted-average period over which the unearned share-based compensation is expected to be recognized is 2.71 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, 2016 and 2015 was based on awards granted under the LTIP. The following table summarizes share-based compensation expense for the periods presented (in thousands):
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The fair value of the options granted to employees and non-employee directors during the three and six months ended June 30, 2016 and 2015 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 share option activity during the six months ended June 30, 2016:
During the three and six months ended June 30, 2016, the total intrinsic value of options exercised was $1.1 million and $1.4 million, respectively, and $3.6 million and $5.8 million during the three and six months ended June 30, 2015, respectively, determined as of the date of exercise. |
Income Taxes |
6 Months Ended |
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Jun. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The major taxing jurisdictions for the Company are Ireland and the U.S. The Company's income tax provision was $189,000 and $370,000 for the three and six months ended June 30, 2016, respectively, and $195,000 and $461,000 for the three and six months ended June 30, 2015, 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 and due to U.S. income taxed at different rates. 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'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. |
Subsequent Events |
6 Months Ended |
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Jun. 30, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events On July 5, 2016, Prothena Biosciences Inc (“PBI”), a wholly owned subsidiary of Prothena Corporation plc, entered into an Agreement to Assign Lease (the “Assignment Agreement”) with Merck Sharp & Dohme Corp. (“Merck”), a wholly owned subsidiary of Merck & Co., Inc., under which PBI agreed to assign to Merck, and Merck agreed to assume from PBI, all of PBI’s right, title and interest as tenant in the lease for the Current Facility (see Note 7, Commitments and Contingencies). On July 11, 2016, PBI, Merck and the landlord entered into a Consent to Assignment and Amendment to Lease, effective as of July 5, 2016, pursuant to which the landlord consented to the Assignment Agreement and the assignment by PBI and the assumption by Merck of PBI’s interest as tenant in the lease contemplated thereby (the “Assignment”), and agreed to release (a) PBI from all of its obligations as tenant under the lease and (b) the Company from all of its obligations as guarantor under that certain Guaranty of Lease dated as of December 21, 2012, in each case that accrue after the Assignment. Under the Assignment Agreement, Merck will pay to PBI the amount of $500,000 as consideration for the assignment of PBI’s interest as tenant in the lease and the amount of $100,000 as consideration for PBI’s transfer to Merck of certain furniture, fixtures and equipment located at the Current Facility. Under the Assignment Agreement, the Assignment will occur five (5) business days after the date when PBI provides written notice to Merck that PBI has vacated and decommissioned the Current Facility and certain other customary conditions are satisfied. PBI intends to vacate the Current Facility when it completes construction at the New Facility. The Assignment Agreement may be terminated by either party if the Assignment does not occur by April 30, 2017, although Merck may extend such date for an additional six (6) months upon notice to PBI. The Assignment Agreement will terminate on October 30, 2017 if the Assignment has not occurred on or before that date. |
Summary of Significant Accounting Policies (Policies) |
6 Months Ended |
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Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Basis of Preparation and Presentation of Financial Information | Basis of Preparation and Presentation of Financial Information These accompanying 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 Regulations 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 (“SEC”) on February 25, 2016 (the "2015 Form 10-K"). These Condensed Consolidated Financial Statements are presented in U.S. dollars, which is the functional currency of the Company and its consolidated subsidiaries. These unaudited 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 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 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. |
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. |
Restricted Cash | Restricted Cash Cash accounts that are restricted to withdrawal or usage are presented as restricted cash. |
Build-to-Suit Leases | Build-to-Suit Leases In certain lease arrangements, the Company is involved in the construction of the building. To the extent the Company is involved with the structural improvements of the construction project or takes construction risk prior to the commencement of a lease, ASC 840-40, “Leases – Sale-Leaseback Transactions (Subsection 05-5),” requires the Company to be considered the owner for accounting purposes of these types of projects during the construction period. Therefore, the Company records an asset in property and equipment, net on the consolidated balance sheets, including capitalized interest costs, for the replacement cost of the pre-existing building plus the amount of estimated construction costs and tenant improvements incurred by the landlord and the Company as of the balance sheet date. The Company records a corresponding build-to-suit lease obligation on its consolidated balance sheets representing the amounts paid by the lessor. Once construction is complete, the Company considers the requirements for sale-leaseback accounting treatment, including evaluating whether all risks of ownership have been transferred back to the landlord, as evidenced by a lack of continuing involvement in the leased property. If the arrangement does not qualify for sale-leaseback accounting treatment, the building asset remains on the Company’s consolidated balance sheets at its historical cost, and such asset is depreciated over its estimated useful life. The Company bifurcates its lease payments into a portion allocated to the building and a portion allocated to the parcel of land on which the building has been built. The portion of the lease payments allocated to the land is treated for accounting purposes as operating lease payments, and therefore is recorded as rent expense in the consolidated statements of operations. The portion of the lease payments allocated to the building is further bifurcated into a portion allocated to interest expense and a portion allocated to reduce the build-to-suit lease obligation. The interest rate used for the build-to-suit lease obligation represents the Company’s estimated incremental borrowing rate at inception of the lease, adjusted to reduce any built in loss. The initial recording of these assets and liabilities is classified as non-cash investing and financing items, respectively, for purposes of the consolidated statements of cash flows. |
Concentration Risk, Credit 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 consolidated balance sheet. Receivable from Roche as of June 30, 2016 and December 31, 2015 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 of amounts recorded on the Company's Consolidated Balance Sheet. As of June 30, 2016, $41.0 million of the Company's long-lived assets were held in the U.S. and $0.8 million were held in Ireland. The Company does not own or operate facilities for the manufacture, storage, testing or distribution of preclinical or clinical supplies of any of its drug candidates. The Company instead contracted with and relies on third-parties to manufacture, store, test and distribute all preclinical development and clinical supplies of its drug candidates, and the Company plans to continue to do so for the foreseeable future. Currently, the Company has a single source of preclinical or clinical supplies for each of its drug candidates. A delay or inability to obtain such supply could have an adverse effect on the Company's business, financial condition and results of operations. |
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), and requires entities to recognize revenue in a way that depicts the transfer of promised goods and services to customers in an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. 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 permits the use of either retrospective or cumulative effect transition method. The Company is currently evaluating the potential impact the adoption of ASU 2014-09 will have on its consolidated financial statements. The Company has not yet selected a transition method nor has it determined the effect of the standard on its ongoing financial reporting. 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. The Company is evaluating the potential impact the adoption of ASU 2016-02 will have on its consolidated financial statements. In March 2016, the FASB issued Accounting Standards Update 2016-09 (ASU 2016-09), Improvements to Employee Share-Based Payment Accounting. Under the new guidance, APIC pools will be eliminated and entities will be required to recognize the income tax effects of share-based awards in the income statement when share-based awards vest or are settled. ASU 2016-09 also changes the classification of excess tax benefits on the statement of cash flows. It also will allow an employer to repurchase more of an employee's shares than it can currently for tax withholding purposes without triggering liability accounting and to make a policy election to either account for forfeitures as they occur or to continue the current practice of estimating forfeitures at the time of grant. ASU 2016-09 is effective prospectively for fiscal years beginning after December 15, 2016, and interim periods within those years. Early adoption is permitted, but all of the guidance must be adopted in the same period. The Company is evaluating the impact the adoption of ASU 2016-09 will have on its consolidated financial statements. |
Composition of Certain Balance Sheet Items (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Composition of Certain Balance Sheet Items [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Property and Equipment | Property and Equipment, net 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) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Calculation of Basic and Diluted Net Income or Loss Per Ordinary Share | Net income (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 income (loss) per share because their effect would be anti-dilutive are as follows (in thousands):
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Commitments and Contingencies (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Operating Lease Commitments | Future minimum payments under noncancelable operating leases and future minimum rentals to be received under the Sublease as of June 30, 2016, 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, 2016, 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, 2016 (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) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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, 2016 and 2015 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 share option activity during the six months ended June 30, 2016:
|
Organization - Additional Information (Detail) - USD ($) $ in Thousands |
Jun. 30, 2016 |
Dec. 31, 2015 |
Jun. 30, 2015 |
Dec. 31, 2014 |
---|---|---|---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Accumulated deficit | $ 197,069 | $ 129,103 | ||
Cash and cash equivalents | $ 442,948 | $ 370,586 | $ 402,389 | $ 293,579 |
Summary of Significant Accounting Policies Summary of Significant Accounting Policies (Details) $ in Thousands |
6 Months Ended | |
---|---|---|
Jun. 30, 2016
USD ($)
segment
|
Dec. 31, 2015
USD ($)
|
|
Concentration Risk [Line Items] | ||
Number of Operating Segments | segment | 1 | |
Restricted cash | $ 4,056 | $ 0 |
UNITED STATES | ||
Concentration Risk [Line Items] | ||
Long-lived assets | 41,000 | |
IRELAND | ||
Concentration Risk [Line Items] | ||
Long-lived assets | $ 800 |
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Millions |
Jun. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Level 1 [Member] | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Money market funds at carrying value | $ 400.9 | $ 320.5 |
Composition of Certain Balance Sheet Items - Additional Information (Detail) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2016 |
Jun. 30, 2015 |
Jun. 30, 2016 |
Jun. 30, 2015 |
|
Composition of Certain Balance Sheet Items [Abstract] | ||||
Depreciation expense | $ 0.4 | $ 0.2 | $ 0.7 | $ 0.4 |
Composition of Certain Balance Sheet Items - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands |
Jun. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Composition of Certain Balance Sheet Items [Abstract] | ||
Machinery and equipment | $ 6,323 | $ 6,210 |
Leasehold improvements | 2,764 | 2,828 |
Purchased computer software | 225 | 167 |
Construction-in-progress build-to-suit | 38,554 | 0 |
Property and equipment, gross | 47,866 | 9,205 |
Less: accumulated depreciation and amortization | (6,014) | (5,343) |
Property and equipment, net | $ 41,852 | $ 3,862 |
Composition of Certain Balance Sheet Items - Schedule of Other Current Liabilities (Detail) - USD ($) $ in Thousands |
Jun. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Composition of Certain Balance Sheet Items [Abstract] | ||
Payroll and related expenses | $ 3,035 | $ 3,774 |
Professional services | 615 | 325 |
Deferred rent | 320 | 284 |
Other | 1,244 | 520 |
Other current liabilities | $ 5,214 | $ 4,903 |
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, 2016 |
Jun. 30, 2015 |
Jun. 30, 2016 |
Jun. 30, 2015 |
|
Numerator: | ||||
Net loss | $ (40,445) | $ (18,277) | $ (67,966) | $ (33,479) |
Shares used to compute basic and diluted net loss per share (in shares) | 34,358 | 30,792 | 34,192 | 29,106 |
Basic and diluted net loss per share (in dollars per share) | $ (1.18) | $ (0.59) | $ (1.99) | $ (1.15) |
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, 2016 |
Jun. 30, 2015 |
Jun. 30, 2016 |
Jun. 30, 2015 |
|
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 Income (loss) per share | 4,121 | 3,290 | 4,121 | 3,290 |
Build-to-Suit Lease (Details) $ in Thousands |
1 Months Ended | 3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|---|
Mar. 31, 2016
ft²
|
Jun. 30, 2016
USD ($)
|
Jun. 30, 2016
USD ($)
|
Jun. 30, 2015
USD ($)
|
Apr. 30, 2016
USD ($)
|
|
Build-to-Suit Lease Obligations [Line Items] | |||||
Interest capitalized during construction period for build-to-suit lease transaction | $ 326 | $ 0 | |||
Built-to-Suit Lease [Member] | |||||
Build-to-Suit Lease Obligations [Line Items] | |||||
Build-to-suit Lease, Term of Contract | 7 years 9 months 30 days | ||||
Build-to-suit Area of real estate property (in sq ft) | ft² | 128,751 | ||||
Build-to-suit Lease Expiration Date | Dec. 31, 2023 | ||||
Future payments due | $ 39,022 | $ 39,022 | $ 39,200 | ||
Tenant Improvement Allowance | 14,200 | ||||
Amount capitalized under Build-to-Suit Transaction | 35,600 | ||||
Interest capitalized during construction period for build-to-suit lease transaction | 326 | ||||
Tenant Improvements Incurred | 2,900 | ||||
Ground Rent | $ 100 | $ 100 | |||
Line of Credit Facility | $ 4,100 |
Commitment and Contingencies Commitment and Contingencies - Schedule of Future Minimum Lease Payments (Details) $ in Thousands |
Jun. 30, 2016
USD ($)
|
---|---|
Operating Lease | |
2016 (six months) | $ 1,090 |
2017 | 2,246 |
2018 | 2,326 |
2019 | 2,410 |
2020 | 2,287 |
Thereafter | 1,073 |
Total | 11,432 |
Sublease Rental | |
2016 (six months) | (261) |
2017 | (316) |
2018 | 0 |
2019 | 0 |
2020 | 0 |
Thereafter | 0 |
Total | $ (577) |
Commitment and Contingencies Commitment and Contingencies - Build-To-Suit (Details) - Built-to-Suit Lease [Member] - USD ($) $ in Thousands |
Jun. 30, 2016 |
Apr. 30, 2016 |
---|---|---|
Build-to-suit Lease [Line Items] | ||
2016 (six months) | $ 0 | |
2017 | 3,275 | |
2018 | 4,915 | |
2019 | 5,803 | |
2020 | 5,979 | |
Thereafter | 19,050 | |
Future payments due | $ 39,022 | $ 39,200 |
Commitment and Contingencies - Contractual Obligations (Details) $ in Thousands |
Jun. 30, 2016
USD ($)
|
---|---|
Purchase Obligations | |
Total | $ 17,181 |
2016 (six months) | 16,980 |
2017 | 86 |
2018 | 53 |
2019 | 30 |
2020 | 32 |
Thereafter | 0 |
Purchase and Contractual Obligations, Fiscal Year Maturity | |
Total | 18,571 |
2016 (six months) | 17,120 |
2017 | 206 |
2018 | 173 |
2019 | 150 |
2020 | 122 |
Thereafter | 800 |
Accrued Liabilities [Member] | |
Purchase and Contractual Obligations, Fiscal Year Maturity | |
Contractual obligations under license agreements included in accrued current liabilities | 100 |
Commitment to suppliers included in accrued liabilities | 11,500 |
Licensing Agreements [Member] | |
Contractual obligations under license agreements | |
Total | 1,400 |
License Agreements [Member] | |
Contractual obligations under license agreements | |
Total | 1,390 |
2016 (six months) | 140 |
2017 | 120 |
2018 | 120 |
2019 | 120 |
2020 | 90 |
Thereafter | $ 800 |
Shareholders' Equity (Issuance of Ordinary Shares) (Details) - Underwritten Public And Over-Allotment Offering [Member] $ / shares in Units, $ in Millions |
1 Months Ended |
---|---|
Jan. 31, 2016
USD ($)
$ / shares
shares
| |
Shareholders Equity [Line Items] | |
Ordinary shares sold (in dollars per share) | $ / shares | $ 53.00 |
Net proceeds from issuance of ordinary shares in underwritten public offering | $ | $ 128.6 |
Ordinary Shares | |
Shareholders Equity [Line Items] | |
Number of shares issued in transaction | shares | 2,587,500 |
Shareholders' Equity (Ordinary Shares/Euro Deferred Shares) (Details) |
6 Months Ended | |||
---|---|---|---|---|
Jun. 30, 2016
vote
$ / shares
shares
|
Jun. 30, 2016
€ / shares
shares
|
Dec. 31, 2015
$ / shares
shares
|
Dec. 31, 2015
€ / shares
shares
|
|
Equity [Abstract] | ||||
Ordinary shares, number of authorized shares | 100,000,000 | 100,000,000 | 100,000,000 | 100,000,000 |
Ordinary shares, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | ||
Ordinary shares, number of issued shares | 34,381,501 | 34,381,501 | 31,744,102 | 31,744,102 |
Ordinary shares, number of outstanding shares | 34,381,501 | 34,381,501 | 31,744,102 | 31,744,102 |
Votes per share | vote | 1 | |||
Euro deferred shares, number of shares authorized | 10,000 | 10,000 | 10,000 | 10,000 |
Euro deferred shares, nominal value (in euros per share) | € / shares | € 22 | € 22 | ||
Euro deferred shares, number of outstanding shares | 0 | 0 | 0 | 0 |
Share-Based Compensation - Summary of Share-Based Compensation Expense (Detail) - USD ($) |
3 Months Ended | 6 Months Ended | ||||
---|---|---|---|---|---|---|
Jun. 30, 2016 |
Jun. 30, 2015 |
Jun. 30, 2016 |
Jun. 30, 2015 |
|||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense | $ 4,546,000 | $ 2,416,000 | $ 8,270,000 | $ 4,119,000 | ||
Consultant [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense on option | 0 | 0 | 0 | 42,000 | ||
Research and development [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense | [1] | 1,818,000 | 969,000 | 3,237,000 | 1,727,000 | |
General and administrative [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense | $ 2,728,000 | $ 1,447,000 | $ 5,033,000 | $ 2,392,000 | ||
|
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, 2016 |
Jun. 30, 2015 |
Jun. 30, 2016 |
Jun. 30, 2015 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility | 75.60% | 75.30% | 74.90% | 76.10% |
Risk-free interest rate | 1.50% | 1.80% | 1.40% | 1.80% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Expected life | 6 years | 6 years | 6 years | 6 years |
Weighted average fair value | $ 28.72 | $ 25.50 | $ 23.52 | $ 19.54 |
Income Taxes - Additional Information (Details) - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2016 |
Jun. 30, 2015 |
Jun. 30, 2016 |
Jun. 30, 2015 |
|
Income Taxes [Line Items] | ||||
Income tax expense (benefit) | $ 189,000 | $ 195,000 | $ 370,000 | $ 461,000 |
Revenue Commissioners, Ireland [Member] | ||||
Income Taxes [Line Items] | ||||
Ireland statutory tax rate, percent | 12.50% | 12.50% |
Subsequent Events Subsequent Events (Details) - Prothena Biosciences, Inc. [Member] - Subsequent Event [Member] |
Jul. 05, 2016
USD ($)
|
---|---|
Subsequent Event [Line Items] | |
Consideration received to convey tenant interest | $ 500,000 |
Consideration received to convey furniture, fixtures, and equipment | $ 100,000 |
Number of days after vacating Assignment will occur (in days) | 5 days |
Extension period of Assignment (in months) | 6 months |
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