x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Ireland
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98-1111119
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number)
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Alexandra House
The Sweepstakes, Ballsbridge
Dublin 4, Ireland
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(Address of principal executive offices including Zip Code)
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Title of Each Class
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Name of Each Exchange on Which Registered
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Ordinary Shares, par value $0.01 per share
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The Nasdaq Global Select Market
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Large accelerated filer
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o
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Accelerated filer
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x
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Non-accelerated filer
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¨
(Do not check if a smaller reporting company)
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Smaller reporting company
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o
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Page
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Item 1.
Business
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Item 1B. Unresolved Staff Comments
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Item 2.
Properties
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Item 3.
Legal Proceedings
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Item 4. Mine Safety Disclosures
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Item 5.
Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
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Item 6.
Selected Financial Data
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Item 8. Financial Statements
and Supplementary Data
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Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
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Item 9B.
Other Information
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Item 10.
Directors, Executive Officers and Corporate Governance
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Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
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Item 13.
Certain Relationships and Related Transactions, and Director Independence
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Item 14.
Principal Accounting Fees and Services
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Item 15.
Exhibits, Financial Statement Schedules
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Continue to discover antibodies directed against novel targets related to amyloid or cell adhesion.
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Quickly translate our research discoveries into clinical development.
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Establish early clinical proof of concept with our therapeutic antibodies.
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Focus on
diseases that lack effective therapies.
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Strategically collaborate or out-license select programs.
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Highly leverage external talent and resources.
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Collaborate with scientific and clinical experts in disease areas of interest.
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Evaluate commercialization strategies in order to maximize the value of our product candidates or future potential products.
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up to $380.0 million upon the achievement of development, regulatory and various first commercial sales milestones;
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up to an additional $175.0 million in ex-U.S. commercial sales milestones; and
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tiered, high single-digit to high double-digit royalties in the teens on ex-U.S. annual net sales, subject to certain adjustments.
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submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be
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completion of extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with the FDA’s Good Laboratory Practice ("GLP") regulations;
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performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for each proposed indication, all performed in accordance with FDA’s current good clinical practices ("cGCP") regulations;
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submission to the FDA of a BLA for a new biologic, after completion of all pivotal clinical trials;
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satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the product is produced and tested to assess compliance with current good manufacturing practices ("cGMP") regulations; and
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FDA review and approval of a BLA for a new biologic, prior to any commercial marketing or sale of the product in the U.S.
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Phase 1.
Phase 1 includes the initial introduction of an investigational product into humans. Phase 1 clinical trials are typically closely monitored and may be conducted in patients with the target disease or condition or in healthy volunteers. These studies are designed to evaluate the safety, dosage tolerance, metabolism and pharmacologic actions of the investigational product in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness. During Phase 1 clinical trials, sufficient information about the investigational product’s pharmacokinetics and pharmacological effects may be obtained to permit the design of well-controlled and scientifically valid Phase 2 clinical trials. The total number of participants included in Phase 1 clinical trials varies, but is generally in the range of 20 to 80;
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Phase 2.
Phase 2 includes controlled clinical trials conducted to preliminarily or further evaluate the effectiveness of the investigational product for a particular indication(s) in patients with the disease or condition under study, to determine dosage tolerance and optimal dosage, and to identify possible adverse side effects and safety risks associated with the product. Phase 2 clinical trials are typically well-controlled, closely monitored, and conducted in a limited patient population, usually involving no more than several hundred participants; and
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Phase 3.
Phase 3 clinical trials are generally controlled clinical trials conducted in an expanded patient population generally at geographically dispersed clinical trial sites. They are performed after preliminary evidence suggesting effectiveness of the product has been obtained, and are intended to further evaluate dosage, clinical effectiveness and safety, to establish the overall benefit-risk relationship of the investigational product, and to provide an adequate basis
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Approximately 57 patent and patent applications related to AL or AA amyloidosis, including our NEOD001 program;
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Approximately 133 patents and patent applications related to Parkinson’s disease and other synucleinopathies,
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Approximately 20 patents and patent applications related to psoriasis and other inflammatory diseases, including our PRX003 program; and
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Approximately 77 patents and patent applications related to other potential targets of intervention.
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conduct our Phase 3 and Phase 1/2 clinical trials for NEOD001, conduct our Phase 1 clinical trials for PRX002, and initiate additional clinical trials for these and other programs;
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develop and commercialize our product candidates, including NEOD001, PRX002 and PRX003;
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complete preclinical development of other product candidates and initiate clinical trials, if supported by positive preclinical data; and
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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.
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the timing of initiation, progress, results and costs of our clinical trials, including our Phase 3 and Phase 1/2 clinical trials for NEOD001, our Phase 1 clinical trials for PRX002, and our contemplated Phase 1 clinical trial for PRX003;
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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;
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the results of our research and preclinical studies;
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the costs of clinical manufacturing and of establishing commercial manufacturing arrangements and other commercialization needs;
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the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims;
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our ability to establish research collaborations, strategic collaborations, licensing or other arrangements;
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the costs to satisfy our obligations under potential future collaborations; and
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the timing, receipt, and amount of revenues or royalties, if any, from any approved drug candidates.
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terminate or delay clinical trials or other development for one or more of our drug candidates;
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delay arrangements for activities that may be necessary to commercialize our drug candidates;
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curtail or eliminate our drug research and development programs that are designed to identify new drug candidates; or
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cease operations.
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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;
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subsequent to the completion of the Separation and Distribution, 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 and Distribution because Elan’s cost of debt was lower than ours has been and will likely continue to be; and
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our historical financial information does not reflect changes that we have incurred as a result of the separation of our business 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.
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offer improvement over existing, comparable products;
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be proven safe and effective in clinical trials; or
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meet applicable regulatory standards.
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obtaining and maintaining commercial manufacturing arrangements with third-party manufacturers;
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collaborating with pharmaceutical companies or contract sales organizations to market and sell any approved drug; or
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acceptance of any approved drug in the medical community and by patients and third-party payors.
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conditions imposed on us by the FDA or any foreign regulatory authority regarding the scope or design of our clinical trials;
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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;
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insufficient supply or deficient quality of our drug candidates or other materials necessary to conduct our clinical trials;
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delays in obtaining regulatory agency agreement for the conduct of our clinical trials;
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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;
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serious and unexpected drug-related side effects experienced by patients in clinical trials; or
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failure of our third-party contractors to meet their contractual obligations to us in a timely manner.
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failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
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inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
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varying interpretation of data by the FDA or other regulatory authorities;
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requirement by the FDA or other regulatory authorities to perform additional studies;
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failure to achieve primary or secondary endpoints or other failure to demonstrate efficacy;
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unforeseen safety issues; or
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lack of adequate funding to continue the clinical trial.
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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
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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;
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the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
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we may be unable to demonstrate that a drug candidate’s clinical and other benefits outweigh its safety risks;
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the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
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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;
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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
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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.
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restrictions on the marketing of our products or their manufacturing processes;
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warning letters;
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civil or criminal penalties;
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fines;
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injunctions;
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product seizures or detentions;
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import or export bans;
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voluntary or mandatory product recalls and related publicity requirements;
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suspension or withdrawal of regulatory approvals;
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total or partial suspension of production; and
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refusal to approve pending applications for marketing approval of new products or supplements to approved applications.
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regulatory authorities may withdraw their approval of the product;
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regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;
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we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;
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we could be sued and held liable for harm caused to patients; and
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our reputation may suffer.
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the indication and label for the product and the timing of introduction of competitive products;
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demonstration of clinical safety and efficacy compared to other products;
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prevalence and severity of adverse side effects;
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availability of coverage and adequate reimbursement from managed care plans and other third-party payors;
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convenience and ease of administration;
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cost-effectiveness;
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other potential advantages of alternative treatment methods; and
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the effectiveness of marketing and distribution support of the product.
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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;
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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;
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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;
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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;
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extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
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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;
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a licensure framework for follow-on biologic products;
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expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
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new requirements under the federal Open Payments program and its implementing regulations;
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a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
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a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
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significantly greater financial, technical and human resources than we have and may be better equipped to discover, develop, manufacture and commercialize drug candidates;
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more extensive experience in preclinical testing and clinical trials, obtaining regulatory approvals and manufacturing and marketing pharmaceutical products;
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drug candidates that have been approved or are in late-stage clinical development; and/or
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collaborative arrangements in our target markets with leading companies and research institutions
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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;
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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
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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;
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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;
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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
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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 with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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decreased demand for any approved drug candidates;
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impairment of our business reputation;
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withdrawal of clinical trial participants;
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costs of related litigation;
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distraction of management’s attention;
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substantial monetary awards to patients or other claimants; and
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loss of revenues; and the inability to successfully commercialize any approved drug candidates.
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the patentability of our inventions relating to our drug candidates; and/or
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the enforceability, validity or scope of protection offered by our patents relating to our drug candidates.
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incur substantial monetary damages;
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encounter significant delays in bringing our drug candidates to market; and/or
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be precluded from participating in the manufacture, use or sale of our drug candidates or methods of treatment requiring licenses.
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our ability to obtain financing as needed;
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progress in and results from our ongoing or future clinical trials;
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our collaboration with Roche pursuant to the License Agreement to develop and commercialize PRX002, as well as any future Licensed Products targeting alpha-synuclein;
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failure or delays in advancing our preclinical drug candidates or other drug candidates we may develop in the future, into clinical trials;
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results of clinical trials conducted by others on drugs that would compete with our drug candidates;
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issues in manufacturing our drug candidates;
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regulatory developments or enforcement in the U.S. and foreign countries;
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developments or disputes concerning patents or other proprietary rights;
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introduction of technological innovations or new commercial products by our competitors;
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changes in estimates or recommendations by securities analysts, if any, who cover our company;
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public concern over our drug candidates;
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litigation;
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future sales of our ordinary shares;
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general market conditions;
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changes in the structure of healthcare payment systems;
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failure of any of our drug candidates, if approved, to achieve commercial success;
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economic and other external factors or other disasters or crises;
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period-to-period fluctuations in our financial results;
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overall fluctuations in U.S. equity markets;
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our quarterly or annual results, or those of other companies in our industry;
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announcements by us or our competitors of significant acquisitions or dispositions;
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the operating and ordinary share price performance of other comparable companies;
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•
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investor perception of our company and the drug development industry;
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natural or environmental disasters that investors believe may affect us; or
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•
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fluctuations in the budgets of federal, state and local governmental entities around the world.
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Cumulative Total Return as of
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12/21/2012
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12/31/2012
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6/30/2013
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12/31/2013
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6/30/2014
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12/31/2014
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|||
Prothena Corporation plc
|
|
$100
|
|
$102
|
|
$179
|
|
$
|
368
|
|
|
$
|
313
|
|
|
$
|
288
|
|
Nasdaq Composite Index
|
|
$100
|
|
$100
|
|
$113
|
|
$
|
138
|
|
|
$
|
146
|
|
|
$
|
157
|
|
Nasdaq Biotechnology Index
|
|
$100
|
|
$99
|
|
$126
|
|
$
|
164
|
|
|
$
|
186
|
|
|
$
|
220
|
|
|
|
Year Ended December 31,
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||||||||||||||||||
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
|
2010
|
||||||||||
Consolidated Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Collaboration revenue
|
|
$
|
50,320
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Revenue—related party
|
|
534
|
|
|
676
|
|
|
2,658
|
|
|
507
|
|
|
1,243
|
|
|||||
Total revenue
|
|
50,854
|
|
|
676
|
|
|
2,658
|
|
|
507
|
|
|
1,243
|
|
|||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development
|
|
38,452
|
|
|
26,052
|
|
|
34,139
|
|
|
24,172
|
|
|
9,787
|
|
|||||
General and administrative
|
|
19,051
|
|
|
15,051
|
|
|
9,929
|
|
|
5,579
|
|
|
3,618
|
|
|||||
Total operating expenses
|
|
57,503
|
|
|
41,103
|
|
|
44,068
|
|
|
29,751
|
|
|
13,405
|
|
|||||
Loss from operations
|
|
(6,649
|
)
|
|
(40,427
|
)
|
|
(41,410
|
)
|
|
(29,244
|
)
|
|
(12,162
|
)
|
|||||
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest income
|
|
79
|
|
|
71
|
|
|
5
|
|
|
—
|
|
|
—
|
|
|||||
Other income (expense), net
|
|
231
|
|
|
(225
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total other income (expense)
|
|
310
|
|
|
(154
|
)
|
|
5
|
|
|
—
|
|
|
—
|
|
|||||
Loss before income taxes
|
|
(6,339
|
)
|
|
(40,581
|
)
|
|
(41,405
|
)
|
|
(29,244
|
)
|
|
(12,162
|
)
|
|||||
Provision for income taxes
|
|
811
|
|
|
415
|
|
|
6
|
|
|
426
|
|
|
320
|
|
|||||
Net loss
|
|
$
|
(7,150
|
)
|
|
$
|
(40,996
|
)
|
|
$
|
(41,411
|
)
|
|
$
|
(29,670
|
)
|
|
$
|
(12,482
|
)
|
Basic and diluted net loss per share
(1)
|
|
$
|
(0.29
|
)
|
|
$
|
(2.20
|
)
|
|
$
|
(2.84
|
)
|
|
$
|
(2.05
|
)
|
|
$
|
(0.86
|
)
|
Shares used to compute basic and diluted net loss per share
|
|
24,672
|
|
|
18,615
|
|
|
14,593
|
|
|
14,497
|
|
|
14,497
|
|
|||||
|
||||||||||||||||||||
|
|
December 31,
|
||||||||||||||||||
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
|
2010
|
||||||||||
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash and cash equivalents
(1)
|
|
$
|
293,579
|
|
|
$
|
176,677
|
|
|
$
|
124,860
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets
|
|
304,116
|
|
|
182,410
|
|
|
129,283
|
|
|
3,618
|
|
|
3,278
|
|
|||||
Other non-current liabilities
|
|
2,188
|
|
|
1,734
|
|
|
1,055
|
|
|
1,650
|
|
|
1,384
|
|
|||||
Total liabilities
|
|
14,227
|
|
|
9,140
|
|
|
2,799
|
|
|
10,054
|
|
|
3,249
|
|
|||||
Shareholders’ and parent company equity (deficit)
|
|
289,889
|
|
|
173,270
|
|
|
126,484
|
|
|
(6,436
|
)
|
|
(30
|
)
|
(1)
|
Prior to the Separation and Distribution completed on December 20, 2012, we operated as part of Elan and not as a separate stand-alone entity. As a result, we did not have any ordinary shares outstanding and cash and cash equivalents prior to December 20, 2012. The calculation of basic and diluted net loss per share assumes that the 14,496,929 ordinary shares issued to Elan shareholders in connection with the separation from Elan have been outstanding for the years ended December 31, 2012 and 2011 and that the 3,182,253 ordinary shares issued to Elan upon separation have been outstanding since December 20, 2012.
|
•
|
our ability to obtain additional financing in future offerings;
|
•
|
our operating losses;
|
•
|
our ability to successfully complete research and development of our drug candidates;
|
•
|
our ability to develop and commercialize products;
|
•
|
our collaboration with Roche pursuant to the License Agreement;
|
•
|
our ability to protect our patents and other intellectual property;
|
•
|
our ability to hire and retain key employees;
|
•
|
tax treatment of our separation from Elan and subsequent distribution of our ordinary shares;
|
•
|
restrictions on our ability to take certain actions due to tax rules and covenants with Elan;
|
•
|
our ability to maintain financial flexibility and sufficient cash, cash equivalents, and investments and other assets capable of being monetized to meet our liquidity requirements;
|
•
|
potential disruptions in the U.S. and global capital and credit markets;
|
•
|
government regulation of our industry;
|
•
|
the volatility of our ordinary share price;
|
•
|
business disruptions; and
|
•
|
the other risks and uncertainties described in the “Risk Factors” section of this Form 10-K.
|
|
Year Ended December 31,
|
|
Percentage Change
|
||||||||||||||
2014
|
|
2013
|
|
2012
|
|
2014/2013
|
|
2013/2012
|
|||||||||
(Dollars in thousands)
|
|
|
|
|
|||||||||||||
Collaboration revenue
|
$
|
50,320
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
nm
|
|
|
nm
|
|
Revenue—related party
|
534
|
|
|
676
|
|
|
2,658
|
|
|
(21
|
)%
|
|
(75
|
)%
|
|||
Total revenue
|
$
|
50,854
|
|
|
$
|
676
|
|
|
$
|
2,658
|
|
|
7,423
|
%
|
|
(75
|
)%
|
|
Year Ended December 31,
|
|
Percentage Change
|
||||||||||||||
2014
|
|
2013
|
|
2012
|
|
2014/2013
|
|
2013/2012
|
|||||||||
(Dollars in thousands)
|
|
|
|
|
|||||||||||||
Research and development
|
$
|
38,452
|
|
|
$
|
26,052
|
|
|
$
|
34,139
|
|
|
48
|
%
|
|
(24
|
)%
|
General and administrative
|
19,051
|
|
|
15,051
|
|
|
9,929
|
|
|
27
|
%
|
|
52
|
%
|
|||
Total operating expenses
|
$
|
57,503
|
|
|
$
|
41,103
|
|
|
$
|
44,068
|
|
|
40
|
%
|
|
(7
|
)%
|
(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
year ended
December 31, 2014
,
$2.4 million
was recorded as an offset to R&D expenses including
$1.7 million
for a portion of the
$15.0 million
milestone received from Roche in the quarter ended June 30, 2014.
|
(3)
|
Other R&D is comprised of preclinical development and discovery programs that have not had successful first patient dosing in a Phase 1 clinical trial, including PRX003, and research costs we incurred in providing research services to Elan.
|
|
Year Ended December 31,
|
|
Percentage Change
|
||||||||||||||
2014
|
|
2013
|
|
2012
|
|
2014/2013
|
|
2013/2012
|
|||||||||
(Dollars in thousands)
|
|
|
|
|
|||||||||||||
Interest income
|
$
|
79
|
|
|
$
|
71
|
|
|
$
|
5
|
|
|
11
|
%
|
|
1,320
|
%
|
Other income (expense), net
|
231
|
|
|
(225
|
)
|
|
—
|
|
|
(203
|
)%
|
|
nm
|
|
|||
Total Other Income (Expense)
|
$
|
310
|
|
|
$
|
(154
|
)
|
|
$
|
5
|
|
|
(301
|
)%
|
|
(3,180
|
)%
|
|
Year Ended December 31,
|
|
Percentage Change
|
||||||||||||||
2014
|
|
2013
|
|
2012
|
|
2014/2013
|
|
2013/2012
|
|||||||||
(Dollars in thousands)
|
|
|
|
|
|||||||||||||
Provision for income taxes
|
$
|
811
|
|
|
$
|
415
|
|
|
$
|
6
|
|
|
95
|
%
|
|
6,817
|
%
|
|
December 31,
2014 |
|
December 31,
2013 |
||||
Working capital
|
$
|
287,236
|
|
|
$
|
170,816
|
|
Cash and cash equivalents
|
293,579
|
|
|
176,677
|
|
||
Total assets
|
304,116
|
|
|
182,410
|
|
||
Other non-current liabilities
|
2,188
|
|
|
1,734
|
|
||
Total liabilities
|
14,227
|
|
|
9,140
|
|
||
Total shareholders’ equity
|
289,889
|
|
|
173,270
|
|
|
Year Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Net cash used in operating activities
|
$
|
(683
|
)
|
|
$
|
(32,098
|
)
|
|
$
|
(42,072
|
)
|
Net cash used in investing activities
|
(499
|
)
|
|
(535
|
)
|
|
(1,301
|
)
|
|||
Net cash provided by financing activities
|
118,084
|
|
|
84,450
|
|
|
168,233
|
|
|||
Net increase in cash and cash equivalents
|
$
|
116,902
|
|
|
$
|
51,817
|
|
|
$
|
124,860
|
|
|
Total
|
2015
|
2016
|
2017
|
2018
|
2019
|
Thereafter
|
||||||||||||||
Operating leases
|
$
|
12,109
|
|
$
|
1,821
|
|
$
|
1,938
|
|
$
|
2,017
|
|
$
|
2,096
|
|
$
|
2,180
|
|
$
|
2,057
|
|
Purchase Obligations
|
3,197
|
|
3,197
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
|||||||
Contractual obligations under license agreements
(1)
|
1,450
|
|
260
|
|
110
|
|
110
|
|
110
|
|
110
|
|
750
|
|
|||||||
Total
|
$
|
16,756
|
|
$
|
5,278
|
|
$
|
2,048
|
|
$
|
2,127
|
|
$
|
2,206
|
|
$
|
2,290
|
|
$
|
2,807
|
|
|
Page
|
Consolidated Financial Statements:
|
|
Reports of Independent Registered Public Accounting Firm
|
|
Consolidated Balance Sheets as of December 31, 2014 and 2013
|
|
Consolidated Statements of Operations for the years ended December 31, 2014, 2013 and 2012
|
|
Consolidated Statements of Cash Flows for the years ended December 31, 2014, 2013 and 2012
|
|
Consolidated Statements of Shareholders’ Equity for the years ended December 31, 2014, 2013 and 2012
|
|
Notes to the Consolidated Financial Statements
|
|
December 31,
|
|
December 31,
|
||||
|
2014
|
|
2013
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
293,579
|
|
|
$
|
176,677
|
|
Receivable from Roche
|
1,729
|
|
|
—
|
|
||
Receivable from related party
|
30
|
|
|
58
|
|
||
Deferred tax assets
|
167
|
|
|
81
|
|
||
Prepaid expenses and other current assets
|
3,770
|
|
|
1,406
|
|
||
Total current assets
|
299,275
|
|
|
178,222
|
|
||
Non-current assets:
|
|
|
|
||||
Property and equipment, net
|
3,121
|
|
|
3,372
|
|
||
Deferred tax assets, non-current
|
1,720
|
|
|
816
|
|
||
Total non-current assets
|
4,841
|
|
|
4,188
|
|
||
Total assets
|
$
|
304,116
|
|
|
$
|
182,410
|
|
Liabilities and Shareholders’ Equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
4,722
|
|
|
$
|
1,790
|
|
Accrued research and development
|
2,285
|
|
|
1,542
|
|
||
Income taxes payable
|
57
|
|
|
184
|
|
||
Other current liabilities
|
4,975
|
|
|
3,890
|
|
||
Total current liabilities
|
12,039
|
|
|
7,406
|
|
||
Non-current liabilities:
|
|
|
|
||||
Income taxes payable, non-current
|
98
|
|
|
—
|
|
||
Deferred rent
|
2,090
|
|
|
1,734
|
|
||
Total non-current liabilities
|
2,188
|
|
|
1,734
|
|
||
Total liabilities
|
14,227
|
|
|
9,140
|
|
||
Commitments and contingencies (Note 6)
|
|
|
|
||||
Shareholders’ equity:
|
|
|
|
||||
Euro deferred shares, €22 nominal value:
|
—
|
|
|
—
|
|
||
Authorized shares — 10,000 at December 31, 2014 and 2013
|
|
|
|
||||
Issued and outstanding shares — none at December 31, 2014 and 2013
|
|
|
|
||||
Ordinary shares, $0.01 par value:
|
274
|
|
|
219
|
|
||
Authorized shares — 100,000,000 at December 31, 2014 and 2013
|
|
|
|
||||
Issued and outstanding shares — 27,388,005 and 21,856,261 at December 31, 2014 and 2013, respectively
|
|
|
|
||||
Additional paid-in capital
|
338,106
|
|
|
214,392
|
|
||
Accumulated deficit
|
(48,491
|
)
|
|
(41,341
|
)
|
||
Total shareholders’ equity
|
289,889
|
|
|
173,270
|
|
||
Total liabilities and shareholders’ equity
|
$
|
304,116
|
|
|
$
|
182,410
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2014
|
|
2013
|
|
2012
|
||||||
Collaboration revenue
|
|
$
|
50,320
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Revenue—related party
|
|
534
|
|
|
676
|
|
|
2,658
|
|
|||
Total revenue
|
|
50,854
|
|
|
676
|
|
|
2,658
|
|
|||
Operating expenses:
|
|
|
|
|
|
|
||||||
Research and development
|
|
38,452
|
|
|
26,052
|
|
|
34,139
|
|
|||
General and administrative
|
|
19,051
|
|
|
15,051
|
|
|
9,929
|
|
|||
Total operating expenses
|
|
57,503
|
|
|
41,103
|
|
|
44,068
|
|
|||
Loss from operations
|
|
(6,649
|
)
|
|
(40,427
|
)
|
|
(41,410
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
|
||||||
Interest income
|
|
79
|
|
|
71
|
|
|
5
|
|
|||
Other income (expense), net
|
|
231
|
|
|
(225
|
)
|
|
—
|
|
|||
Total other income (expense)
|
|
310
|
|
|
(154
|
)
|
|
5
|
|
|||
Loss before income taxes
|
|
(6,339
|
)
|
|
(40,581
|
)
|
|
(41,405
|
)
|
|||
Provision for income taxes
|
|
811
|
|
|
415
|
|
|
6
|
|
|||
Net loss
|
|
$
|
(7,150
|
)
|
|
$
|
(40,996
|
)
|
|
$
|
(41,411
|
)
|
Basic and diluted net loss per share attributable to holders of ordinary shares
|
|
$
|
(0.29
|
)
|
|
$
|
(2.20
|
)
|
|
$
|
(2.84
|
)
|
Shares used to compute basic and diluted net loss per share attributable to holders of ordinary shares
|
|
24,672
|
|
|
18,615
|
|
|
14,593
|
|
|
Year Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Operating activities
|
|
|
|
|
|
||||||
Net loss
|
$
|
(7,150
|
)
|
|
$
|
(40,996
|
)
|
|
(41,411
|
)
|
|
Adjustments to reconcile net loss to cash used in operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization
|
743
|
|
|
660
|
|
|
468
|
|
|||
Share-based compensation
|
5,597
|
|
|
3,128
|
|
|
6,098
|
|
|||
Excess tax benefit from share-based award exercises
|
(242
|
)
|
|
—
|
|
|
—
|
|
|||
Deferred income taxes
|
(990
|
)
|
|
(538
|
)
|
|
—
|
|
|||
Gain on disposal of fixed asset
|
(19
|
)
|
|
(29
|
)
|
|
—
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Receivable from Roche
|
(1,729
|
)
|
|
—
|
|
|
—
|
|
|||
Receivable from related party
|
28
|
|
|
165
|
|
|
(223
|
)
|
|||
Other assets
|
(2,352
|
)
|
|
(721
|
)
|
|
(467
|
)
|
|||
Accounts payable, accruals and other liabilities
|
5,431
|
|
|
6,233
|
|
|
(6,537
|
)
|
|||
Net cash used in operating activities
|
(683
|
)
|
|
(32,098
|
)
|
|
(42,072
|
)
|
|||
Investing activities
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(526
|
)
|
|
(564
|
)
|
|
(1,301
|
)
|
|||
Proceeds from disposal of fixed asset
|
27
|
|
|
29
|
|
|
—
|
|
|||
Net cash used in investing activities
|
(499
|
)
|
|
(535
|
)
|
|
(1,301
|
)
|
|||
Financing activities
|
|
|
|
|
|
||||||
Proceeds from issuance of ordinary shares in public offering, net
|
117,348
|
|
|
84,534
|
|
|
—
|
|
|||
Proceeds from issuance of ordinary shares to Elan
|
—
|
|
|
—
|
|
|
26,000
|
|
|||
Proceeds from funding provided by Elan
|
—
|
|
|
—
|
|
|
145,233
|
|
|||
Repayment of funding provided by Elan
|
—
|
|
|
—
|
|
|
(3,000
|
)
|
|||
Post separation adjustments to the funding provided by Elan
|
—
|
|
|
(84
|
)
|
|
—
|
|
|||
Proceeds from issuance of ordinary shares upon exercise of stock options
|
494
|
|
|
—
|
|
|
—
|
|
|||
Excess tax benefit from share-based award exercises
|
242
|
|
|
—
|
|
|
—
|
|
|||
Net cash provided by financing activities
|
118,084
|
|
|
84,450
|
|
|
168,233
|
|
|||
Net increase in cash and cash equivalents
|
116,902
|
|
|
51,817
|
|
|
124,860
|
|
|||
Cash and cash equivalents, beginning of the year
|
176,677
|
|
|
124,860
|
|
|
—
|
|
|||
Cash and cash equivalents, end of the period
|
$
|
293,579
|
|
|
$
|
176,677
|
|
|
$
|
124,860
|
|
|
|
|
|
|
|
||||||
Supplemental disclosures of cash flow information
|
|
|
|
|
|
||||||
Cash paid for income taxes, net of refunds
|
$
|
1,588
|
|
|
$
|
796
|
|
|
$
|
—
|
|
|
|
|
|
|
|
||||||
Supplemental disclosures of non-cash investing and financing activities
|
|
|
|
|
|
||||||
Acquisition of property and equipment under accounts payable and accrued liabilities
|
$
|
—
|
|
|
$
|
26
|
|
|
$
|
—
|
|
Offering costs in accounts payable and accrued liabilities
|
$
|
—
|
|
|
$
|
82
|
|
|
$
|
—
|
|
Receivable from stock option exercises
|
$
|
6
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Ordinary Shares
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Parent Company Equity
|
|
Total
Shareholders' Equity
(Deficit)
|
|||||||||||||
|
Shares
|
|
Amount
|
|
||||||||||||||||||
Balances at December 31, 2011
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(6,436
|
)
|
|
$
|
(6,436
|
)
|
Contribution of net assets to Prothena and issuance of ordinary shares
|
14,496,929
|
|
|
145
|
|
|
100,684
|
|
|
—
|
|
|
(100,829
|
)
|
|
—
|
|
|||||
Issuance of ordinary shares to Elan
|
3,182,253
|
|
|
32
|
|
|
25,968
|
|
|
—
|
|
|
—
|
|
|
26,000
|
|
|||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,098
|
|
|
6,098
|
|
|||||
Net funding provided by Elan
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
142,233
|
|
|
142,233
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(345
|
)
|
|
(41,066
|
)
|
|
(41,411
|
)
|
|||||
Balances at December 31, 2012
|
17,679,182
|
|
|
177
|
|
|
126,652
|
|
|
(345
|
)
|
|
—
|
|
|
126,484
|
|
|||||
Issuance of ordinary shares in public offering, net of issuance costs of $7.4 million
|
4,177,079
|
|
|
42
|
|
|
84,411
|
|
|
—
|
|
|
—
|
|
|
84,453
|
|
|||||
Share-based compensation
|
—
|
|
|
—
|
|
|
3,128
|
|
|
—
|
|
|
—
|
|
|
3,128
|
|
|||||
Post separation adjustment to the funding provided by Elan
|
—
|
|
|
—
|
|
|
201
|
|
|
—
|
|
|
—
|
|
|
201
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(40,996
|
)
|
|
—
|
|
|
(40,996
|
)
|
|||||
Balances at December 31, 2013
|
21,856,261
|
|
|
219
|
|
|
214,392
|
|
|
(41,341
|
)
|
|
—
|
|
|
173,270
|
|
|||||
Issuance of ordinary shares in public offering, net of issuance costs of $5.5 million
|
5,462,500
|
|
|
54
|
|
|
117,375
|
|
|
—
|
|
|
—
|
|
|
117,429
|
|
|||||
Share-based compensation
|
—
|
|
|
—
|
|
|
5,597
|
|
|
—
|
|
|
—
|
|
|
5,597
|
|
|||||
Excess tax benefit from share-based award exercises
|
—
|
|
|
—
|
|
|
242
|
|
|
—
|
|
|
—
|
|
|
242
|
|
|||||
Issuance of ordinary shares upon exercise of stock options
|
69,244
|
|
|
1
|
|
|
500
|
|
|
—
|
|
|
—
|
|
|
501
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,150
|
)
|
|
—
|
|
|
(7,150
|
)
|
|||||
Balances at December 31, 2014
|
27,388,005
|
|
|
$
|
274
|
|
|
$
|
338,106
|
|
|
$
|
(48,491
|
)
|
|
$
|
—
|
|
|
$
|
289,889
|
|
1.
|
Organization
|
2.
|
Summary of Significant Accounting Policies
|
|
|
Useful Life
|
Machinery and equipment
|
|
4-7 years
|
Leasehold improvements
|
|
Shorter of expected useful life or lease term
|
Purchased computer software
|
|
4 years
|
•
|
unvested Elan options and RSUs that would otherwise have vested within twelve months following the effective date of the Separation and Distribution vested immediately upon the Separation and Distribution, with the RSUs (which by their terms are settled upon vesting) settled in Elan ordinary shares or Elan American Depository Shares ("ADSs") in accordance with their terms;
|
•
|
other unvested Elan options and RSUs were forfeited; and
|
•
|
all vested Elan options (including options the vesting of which were accelerated as described above) will be required to be exercised for Elan ordinary shares or Elan ADSs within twelve months of the effective date of the Separation and Distribution, or will be forfeited.
|
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
|
|
December 31
|
||||||
|
2014
|
|
2013
|
||||
Machinery and equipment
|
$
|
5,481
|
|
|
$
|
5,649
|
|
Leasehold improvements
|
2,214
|
|
|
1,927
|
|
||
Purchased computer software
|
137
|
|
|
85
|
|
||
|
7,832
|
|
|
7,661
|
|
||
Less: accumulated depreciation and amortization
|
(4,711
|
)
|
|
(4,289
|
)
|
||
Property and equipment, net
|
$
|
3,121
|
|
|
$
|
3,372
|
|
|
December 31
|
||||||
|
2014
|
|
2013
|
||||
Payroll and related expenses
|
$
|
3,138
|
|
|
$
|
2,800
|
|
Professional services
|
1,169
|
|
|
616
|
|
||
Deferred rent
|
172
|
|
|
138
|
|
||
Accrued offering costs
|
—
|
|
|
82
|
|
||
Other
|
496
|
|
|
254
|
|
||
Other current liabilities
|
$
|
4,975
|
|
|
$
|
3,890
|
|
5.
|
Net Loss Per Ordinary Share
|
|
Year Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Numerator:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(7,150
|
)
|
|
$
|
(40,996
|
)
|
|
$
|
(41,411
|
)
|
Denominator:
|
|
|
|
|
|
||||||
Weighted-average ordinary shares outstanding
|
24,672
|
|
|
18,615
|
|
|
14,593
|
|
|||
Net income (loss) per share attributable to holders of ordinary shares:
|
|
|
|
|
|
||||||
Basic and diluted net loss per share
|
$
|
(0.29
|
)
|
|
$
|
(2.20
|
)
|
|
$
|
(2.84
|
)
|
|
Year Ended December 31,
|
|||||||
|
2014
|
|
2013
|
|
2012
|
|||
Stock options to purchase ordinary shares
|
2,612
|
|
|
1,974
|
|
|
1,005
|
|
6.
|
Commitments and Contingencies
|
Year Ended December 31,
|
|
Operating Lease
|
|
Sublease Rental
|
||||
2015
|
|
$
|
1,821
|
|
|
$
|
(455
|
)
|
2016
|
|
1,938
|
|
|
(523
|
)
|
||
2017
|
|
2,017
|
|
|
(316
|
)
|
||
2018
|
|
2,096
|
|
|
—
|
|
||
2019
|
|
2,180
|
|
|
—
|
|
||
Thereafter
|
|
2,057
|
|
|
—
|
|
||
Total
|
|
$
|
12,109
|
|
|
$
|
(1,294
|
)
|
|
Total
|
2015
|
2016
|
2017
|
2018
|
2019
|
Thereafter
|
||||||||||||||
Purchase Obligations
|
$
|
3,197
|
|
$
|
3,197
|
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
Contractual obligations under license agreements
(1)
|
1,450
|
|
260
|
|
110
|
|
110
|
|
110
|
|
110
|
|
750
|
|
|||||||
Total
|
$
|
4,647
|
|
$
|
3,457
|
|
$
|
110
|
|
$
|
110
|
|
$
|
110
|
|
$
|
110
|
|
$
|
750
|
|
7.
|
Roche License Agreement
|
8.
|
Shareholders' Equity
|
9.
|
Share-Based Compensation
|
|
Year Ended December 31,
|
||||||||||
|
2014
|
|
2013
|
|
2012
|
||||||
Research and development
(1)
|
$
|
2,270
|
|
|
$
|
980
|
|
|
$
|
6,093
|
|
General and administrative
|
3,327
|
|
|
2,148
|
|
|
5
|
|
|||
Total direct expense
|
$
|
5,597
|
|
|
$
|
3,128
|
|
|
$
|
6,098
|
|
General and administrative — allocated
|
—
|
|
|
—
|
|
|
1,445
|
|
|||
|
$
|
5,597
|
|
|
$
|
3,128
|
|
|
$
|
7,543
|
|
(1)
|
Includes
$108,000
and
$320,000
for the
year
ended
December 31, 2014
and
2013
, respectively, of share-based compensation expense related to options granted to a consultant.
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2014
|
|
2013
|
|
2012
|
||||||
Stock options
|
|
$
|
5,597
|
|
|
$
|
3,128
|
|
|
$
|
2,621
|
|
Restricted stock units
|
|
—
|
|
|
—
|
|
|
3,477
|
|
|||
Total direct
|
|
$
|
5,597
|
|
|
$
|
3,128
|
|
|
$
|
6,098
|
|
Share-based compensation expense-allocated
|
|
—
|
|
|
—
|
|
|
1,445
|
|
|||
|
|
$
|
5,597
|
|
|
$
|
3,128
|
|
|
7,543
|
|
|
|
Year Ended December 31,
|
||
|
|
2014
|
|
2013
|
Expected volatility
|
|
84.4%
|
|
84.0%
|
Risk-free interest rate
|
|
1.8%
|
|
1.2%
|
Expected dividend yield
|
|
—%
|
|
—%
|
Expected life (in years)
|
|
6.0
|
|
6.0
|
Weighted average grant date fair value
|
|
$19.97
|
|
$5.22
|
|
Options
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
Average
Remaining
Contractual
Term (years)
|
|
Aggregate
Intrinsic
Value
(in thousands)
|
|||||
Outstanding at December 31, 2013
|
1,973,500
|
|
|
$
|
7.50
|
|
|
9.17
|
|
$
|
37,528
|
|
Granted
|
720,500
|
|
|
28.02
|
|
|
|
|
|
|||
Exercised
|
(69,244
|
)
|
|
7.23
|
|
|
|
|
|
|||
Canceled
|
(12,676
|
)
|
|
15.97
|
|
|
|
|
|
|||
Outstanding at December 31, 2014
|
2,612,080
|
|
|
$
|
13.13
|
|
|
8.45
|
|
$
|
25,298
|
|
Vested and expected to vest at December 31, 2014
|
2,535,376
|
|
|
$
|
13.00
|
|
|
8.44
|
|
$
|
24,788
|
|
Vested at December 31, 2014
|
1,000,307
|
|
|
$
|
7.35
|
|
|
8.15
|
|
$
|
13,448
|
|
|
|
Options Outstanding
|
|
Options Exercisable
|
|||||||||||||||||
Range of Exercise Prices
|
|
Number of Options
|
|
Weighted -
Average Remaining Contractual Life (Years) |
|
Weighted Average Exercise Price
|
|
Number of Options
|
|
Weighted Average Exercise Price
|
|||||||||||
$
|
6.03
|
|
$
|
6.03
|
|
|
450,937
|
|
|
8.06
|
|
$
|
6.03
|
|
|
216,562
|
|
|
$
|
6.03
|
|
6.41
|
|
6.41
|
|
|
807,381
|
|
|
8.08
|
|
6.41
|
|
|
465,271
|
|
|
6.41
|
|
||||
6.65
|
|
6.65
|
|
|
50,000
|
|
|
8.21
|
|
6.65
|
|
|
50,000
|
|
|
6.65
|
|
||||
6.73
|
|
6.73
|
|
|
366,000
|
|
|
8.25
|
|
6.73
|
|
|
170,478
|
|
|
6.73
|
|
||||
8.21
|
|
22.14
|
|
|
336,062
|
|
|
8.89
|
|
17.51
|
|
|
89,246
|
|
|
15.34
|
|
||||
22.16
|
|
23.11
|
|
|
37,500
|
|
|
9.74
|
|
22.86
|
|
|
—
|
|
|
—
|
|
||||
24.26
|
|
24.26
|
|
|
30,000
|
|
|
8.84
|
|
24.26
|
|
|
8,750
|
|
|
24.26
|
|
||||
29.52
|
|
29.52
|
|
|
25,000
|
|
|
9.09
|
|
29.52
|
|
|
—
|
|
|
—
|
|
||||
29.81
|
|
29.81
|
|
|
479,200
|
|
|
9.09
|
|
29.81
|
|
|
—
|
|
|
—
|
|
||||
37.02
|
|
37.02
|
|
|
30,000
|
|
|
9.25
|
|
37.02
|
|
|
—
|
|
|
—
|
|
||||
$
|
6.03
|
|
$
|
37.02
|
|
|
2,612,080
|
|
|
8.45
|
|
$
|
13.13
|
|
|
1,000,307
|
|
|
$
|
7.35
|
|
|
Year Ended December 31,
|
||
|
2012
|
||
Expected volatility
|
60.1
|
%
|
|
Risk-free interest rate
|
0.9
|
%
|
|
Expected dividend yield
|
—
|
%
|
|
Expected life
(1)
|
4.9 - 6.8
|
|
|
Weighted average fair value
|
$
|
6.66
|
|
(1)
|
The expected life of options granted, as derived from the output of the binomial model, ranged from
4.9
to
6.8 years
in 2012. The contractual life of the options, which is not more than
10 years
from the date of grant, was used as an input into the binomial model.
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2014
|
|
2013
|
|
2012
|
||||||
Ireland
|
|
$
|
(9,714
|
)
|
|
$
|
(42,523
|
)
|
|
$
|
(35,898
|
)
|
U.S.
|
|
3,375
|
|
|
1,942
|
|
|
(5,507
|
)
|
|||
Loss before provision for income taxes
|
|
$
|
(6,339
|
)
|
|
$
|
(40,581
|
)
|
|
$
|
(41,405
|
)
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2014
|
|
2013
|
|
2012
|
||||||
Current:
|
|
|
|
|
|
|
||||||
U.S. Federal
|
|
$
|
1,855
|
|
|
$
|
958
|
|
|
$
|
26
|
|
U.S. State
|
|
1
|
|
|
(5
|
)
|
|
—
|
|
|||
Ireland
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total current provision
|
|
$
|
1,856
|
|
|
$
|
953
|
|
|
$
|
26
|
|
Deferred:
|
|
|
|
|
|
|
||||||
U.S. Federal
|
|
$
|
(1,045
|
)
|
|
$
|
(538
|
)
|
|
$
|
(20
|
)
|
U.S. State
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Ireland
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total deferred benefit
|
|
(1,045
|
)
|
|
(538
|
)
|
|
$
|
(20
|
)
|
||
Total provision for income taxes
|
|
$
|
811
|
|
|
$
|
415
|
|
|
$
|
6
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2014
|
|
2013
|
|
2012
|
||||||
Taxes at the Irish statutory tax rate of 12.5%
|
|
$
|
(792
|
)
|
|
$
|
(5,073
|
)
|
|
$
|
(5,176
|
)
|
Income tax at rates other than applicable statutory rate
|
|
705
|
|
|
(3,169
|
)
|
|
4
|
|
|||
Change in valuation allowance
|
|
2,444
|
|
|
10,365
|
|
|
5,176
|
|
|||
Share-based payments
|
|
74
|
|
|
164
|
|
|
—
|
|
|||
Tax credits
|
|
(1,643
|
)
|
|
(1,921
|
)
|
|
—
|
|
|||
Other
|
|
23
|
|
|
49
|
|
|
2
|
|
|||
Provision for income taxes
|
|
$
|
811
|
|
|
$
|
415
|
|
|
$
|
6
|
|
|
|
December 31
|
||||||
|
|
2014
|
|
2013
|
||||
Deferred tax assets:
|
|
|
|
|
||||
Net operating losses
|
|
$
|
16,322
|
|
|
$
|
15,457
|
|
Tax credits
|
|
1,139
|
|
|
1,310
|
|
||
Accruals
|
|
1,016
|
|
|
1,149
|
|
||
Share-based compensation
|
|
2,225
|
|
|
779
|
|
||
Gross deferred tax assets
|
|
20,702
|
|
|
18,695
|
|
||
Valuation allowance
|
|
(18,815
|
)
|
|
(17,798
|
)
|
||
Net deferred tax assets
|
|
1,887
|
|
|
897
|
|
||
Deferred tax liability
|
|
—
|
|
|
—
|
|
||
Net deferred tax assets
|
|
$
|
1,887
|
|
|
$
|
897
|
|
|
2014
|
|
2013
|
||||
Gross Unrecognized Tax Benefits at January 1
|
$
|
480
|
|
|
$
|
—
|
|
Additions for tax positions taken in the current year
|
253
|
|
|
480
|
|
||
Reductions for tax positions taken in the prior year
|
(350
|
)
|
|
—
|
|
||
Gross Unrecognized Tax Benefits at December 31
|
$
|
383
|
|
|
$
|
480
|
|
|
Quarter
|
||||||||||||||
|
First
|
|
Second
|
|
Third
|
|
Fourth
|
||||||||
Year Ended December 31, 2014
|
|
|
|
|
|
|
|
||||||||
Revenues
|
$
|
32,234
|
|
|
$
|
15,121
|
|
|
$
|
1,486
|
|
|
$
|
2,013
|
|
Operating expenses
|
$
|
14,215
|
|
|
$
|
13,552
|
|
|
$
|
14,618
|
|
|
$
|
15,118
|
|
Net income (loss)
|
$
|
17,852
|
|
|
$
|
1,290
|
|
|
$
|
(13,182
|
)
|
|
$
|
(13,110
|
)
|
Net income (loss) per share - basic
|
$
|
0.82
|
|
|
$
|
0.06
|
|
|
$
|
(0.48
|
)
|
|
$
|
(0.48
|
)
|
Net income (loss) per share - diluted
|
$
|
0.78
|
|
|
$
|
0.06
|
|
|
$
|
(0.48
|
)
|
|
$
|
(0.48
|
)
|
Year Ended December 31, 2013
|
|
|
|
|
|
|
|
||||||||
Revenues
|
$
|
171
|
|
|
$
|
167
|
|
|
$
|
171
|
|
|
$
|
167
|
|
Operating expenses
|
$
|
9,138
|
|
|
$
|
11,359
|
|
|
$
|
9,737
|
|
|
$
|
10,869
|
|
Net loss
|
$
|
(8,951
|
)
|
|
$
|
(11,302
|
)
|
|
$
|
(9,689
|
)
|
|
$
|
(11,054
|
)
|
Net loss per share - basic and diluted
|
$
|
(0.51
|
)
|
|
$
|
(0.64
|
)
|
|
$
|
(0.55
|
)
|
|
$
|
(0.52
|
)
|
•
|
Pertain to the maintenance of records that accurately and fairly reflect in reasonable detail the transactions and dispositions of the assets of our company;
|
•
|
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
|
•
|
Provide reasonable assurances regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material adverse effect on our financial statements.
|
•
|
Election of Directors
|
•
|
Section 16(a) Beneficial Ownership Reporting Compliance
|
Name
|
|
Age
|
|
Position(s)
|
|
Since
|
Dale B. Schenk, Ph.D.
|
|
57
|
|
President and Chief Executive Officer, Director
|
|
2012
|
A. W. Homan
|
|
55
|
|
Chief Legal Officer
|
|
2014
|
Gene G. Kinney, Ph.D.
|
|
46
|
|
Chief Scientific Officer and Head of Research and Development
|
|
2012
|
Martin Koller, M.D.
|
|
64
|
|
Chief Medical Officer
|
|
2013
|
Tran B. Nguyen
|
|
41
|
|
Chief Financial Officer
|
|
2013
|
Tara Nickerson, Ph.D.
|
|
42
|
|
Chief Business Officer
|
|
2014
|
Karin L. Walker
|
|
51
|
|
Chief Accounting Officer, Controller and Head of Accounting
|
|
2013
|
•
|
Executive Compensation
|
•
|
Election of Directors
|
•
|
Equity Compensation Plan Information
|
•
|
Security Ownership of Certain Beneficial Owners and Management
|
•
|
Certain Transactions with Related Persons
|
•
|
Election of Directors
|
•
|
Ratification of Appointment of Independent Registered Public Accounting Firm - Pre-Approval Policies and Procedures
|
(1)
|
Financial Statements.
Reference is made to the Index to the registrant’s Financial Statements under Item 8 in Part II of this Form 10-K.
|
(2)
|
Financial Statement Schedules.
Financial statement schedules have been omitted because the required information is not present or not present in the amounts sufficient to require submission of the schedule or because the information is already included in the consolidated financial statements or notes thereto.
|
(3)
|
Exhibits.
The exhibits listed on the accompanying index to exhibits in Item 15(b) below are filed as part of, or hereby incorporated by reference into, this report on Form 10-K.
|
Dated:
|
March 12, 2015
|
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
|
Name
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/Dale B. Schenk
|
|
President and Chief Executive Officer
|
|
March 12, 2015
|
Dale B. Schenk, Ph.D.
|
|
(Principal Executive Officer) and Director
|
|
|
|
|
|
|
|
/s/Tran B. Nguyen
|
|
Chief Financial Officer
|
|
March 12, 2015
|
Tran B. Nguyen
|
|
(Principal Financial Officer)
|
|
|
|
|
|
|
|
/s/Karin L. Walker
|
|
Controller, Chief Accounting Officer and Head of Accounting
|
|
March 12, 2015
|
Karin L. Walker
|
|
(Principal Accounting Officer)
|
|
|
|
|
|
|
|
/s/Lars G. Ekman
|
|
Chairman of the Board
|
|
March 12, 2015
|
Lars G. Ekman, M.D., Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/Richard T. Collier
|
|
Director
|
|
March 12, 2015
|
Richard T. Collier
|
|
|
|
|
|
|
|
|
|
/s/Shane M. Cooke
|
|
Director
|
|
March 12, 2015
|
Shane M. Cooke
|
|
|
|
|
|
|
|
|
|
/s/Christopher S. Henney
|
|
Director
|
|
March 12, 2015
|
Christopher S. Henney, D.Sc., Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/Dennis J. Selkoe
|
|
Director
|
|
March 12, 2015
|
Dennis J. Selkoe, M.D.
|
|
|
|
|
|
|
|
|
Previously Filed
|
|
||||
Exhibit
No.
|
|
Description
|
|
Form
|
|
File No.
|
Filing Date
|
Exhibit
|
Filed Herewith
|
|
|
|
|
|
|
|
|
|
|
2.1
|
|
Demerger Agreement, dated as of November 8, 2012, between Elan Corporation, plc and Prothena Corporation plc
|
|
10/A
|
|
001-35676
|
11/30/2012
|
2.1
|
|
|
|
|
|
|
|
|
|
|
|
2.2(a)
|
|
Amended and Restated Intellectual Property License and Contribution Agreement, dated as of December 20, 2012, by and among Neotope Biosciences Limited, Elan Pharma International Limited, and Elan Pharmaceuticals, Inc.
|
|
8-K
|
|
001-35676
|
12/21/2012
|
2.1
|
|
|
|
|
|
|
|
|
|
|
|
2.2(b)
|
|
Amendment Number One to the Amended and Restated Intellectual Property License and Contribution Agreement, effective as of December 20, 2012, among Neotope Biosciences Limited, Elan Pharma International Limited, Elan Pharmaceuticals, LLC, Elan Corporation, plc, and Crimagua Limited
|
|
S-1/A
|
|
333-191218
|
9/30/2013
|
2.2(b)
|
|
|
|
|
|
|
|
|
|
|
|
2.3
|
|
Intellectual Property License and Conveyance Agreement, dated as of December 20, 2012, among Neotope Biosciences Limited, Elan Pharma International Limited and Elan Pharmaceuticals, Inc.
|
|
8-K
|
|
001-35676
|
12/21/2012
|
2.2
|
|
|
|
|
|
|
|
|
|
|
|
2.4
|
|
Asset Purchase Agreement, dated as of December 20, 2012, between Elan Pharmaceuticals, Inc. and Prothena Biosciences Inc
|
|
8-K
|
|
001-35676
|
12/21/2012
|
2.3
|
|
|
|
|
|
|
|
|
|
|
|
3.1
|
|
Amended and Restated Memorandum and Articles of Association of Prothena Corporation plc
|
|
10-K
|
|
001-35676
|
3/29/2013
|
3.1
|
|
|
|
|
|
|
|
|
|
|
|
4.1
|
|
Reference is made to Exhibit 3.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.1(a)
|
|
Tax Matters Agreement, dated as of December 20, 2012, between Elan Corporation, plc and Prothena Corporation plc
|
|
8-K
|
|
001-35676
|
12/21/2012
|
10.1
|
|
|
|
|
|
|
|
|
|
|
|
10.1(b)
|
|
Amendment No. 1 to Tax Matters Agreement, dated as of June 25, 2013, between Elan Corporation, plc and Prothena Corporation plc
|
|
10-Q
|
|
001-35676
|
8/13/2013
|
10.2
|
|
|
|
|
|
|
|
|
|
|
|
10.2
|
|
Subscription and Registration Rights Agreement, dated as of November 8, 2012, among Prothena Corporation plc, Elan Corporation, plc and Elan Science One Limited
|
|
10/A
|
|
001-35676
|
11/30/2012
|
10.3
|
|
|
|
|
|
|
|
|
|
|
|
10.3†
|
|
License, Development, and Commercialization Agreement, dated as of December 11, 2013, among Neotope Biosciences Limited and Prothena Biosciences Inc with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc.
|
|
10-K/A
|
|
001-35676
|
6/6/2014
|
10.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Previously Filed
|
|
||||
Exhibit
No.
|
|
Description
|
|
Form
|
|
File No.
|
Filing Date
|
Exhibit
|
Filed Herewith
|
|
|
|
|
|
|
|
|
|
|
10.4†
|
|
Master Process Development and Clinical Supply Agreement, dated June 23, 2010, as amended August 1, 2011, among Elan Pharma International Limited, Neotope Biosciences limited and Boehringer Ingelheim Pharma GmbH & Co. KG
|
|
10-Q
|
|
001-35676
|
8/13/2013
|
10.3
|
|
|
|
|
|
|
|
|
|
|
|
10.5
|
|
Research and Development Services Agreement, dated as of December 20, 2012, between Elan Corporation, plc and Prothena Corporation plc
|
|
8-K
|
|
001-35676
|
12/21/2012
|
10.3
|
|
|
|
|
|
|
|
|
|
|
|
10.6#
|
|
Form of Deed of Indemnification between Prothena Corporation plc and its Directors and Officers
|
|
8-K
|
|
001-35676
|
12/11/2014
|
10.1
|
|
|
|
|
|
|
|
|
|
|
|
10.7(a)
|
|
Lease Agreement, dated as of March 18, 2010, between Are-San Francisco No. 33, LLC and Elan Pharmaceuticals, Inc.
|
|
10/A
|
|
001-35676
|
11/30/2012
|
10.6
|
|
|
|
|
|
|
|
||||
10.7(b)
|
|
First Amendment to Lease, dated as of November 18, 2011, between Are-San Francisco No. 33, LLC and Elan Pharmaceuticals, Inc.
|
|
10/A
|
|
001-35676
|
11/30/2012
|
10.7
|
|
|
|
|
|
|
|
|
|
|
|
10.7(c)
|
|
Second Amendment to Lease, dated as of June 1, 2012, between Are-San Francisco No. 33, LLC and Elan Pharmaceuticals, Inc.
|
|
10/A
|
|
001-35676
|
11/30/2012
|
10.8
|
|
|
|
|
|
|
|
|
|
|
|
10.7(d)
|
|
Third Amendment to Lease, dated as of October 3, 2012, between Are-San Francisco No. 33, LLC and Elan Pharmaceuticals, Inc.
|
|
10/A
|
|
001-35676
|
11/30/2012
|
10.9
|
|
|
|
|
|
|
|
|
|
|
|
10.7(e)
|
|
Assignment of Tenant’s Interest in Lease and Assumption of Lease Obligations, dated as of December 2, 2012, between Elan Pharmaceuticals, Inc. and Prothena Biosciences Inc
|
|
10/A
|
|
001-35676
|
11/30/2012
|
10.10
|
|
|
|
|
|
|
|
|
|
|
|
10.7(f)
|
|
Fourth Amendment to Lease, dated as of November 30, 2013, between ARE-San Francisco No. 33, LLC and Prothena Biosciences, Inc
|
|
8-K
|
|
001-35676
|
12/5/2013
|
10.1
|
|
|
|
|
|
|
|
|
|
|
|
10.8#
|
|
Prothena Corporation plc Amended and Restated 2012 Long Term Incentive Plan
|
|
S-8
|
|
333-196572
|
6/6/2014
|
99.1
|
|
|
|
|
|
|
|
|
|
|
|
10.9#
|
|
Form of Option Award Agreement between Prothena Corporation plc and Registrant’s Non-Employee Directors (used beginning January 29, 2013)
|
|
S-8
|
|
333-196572
|
6/6/2014
|
99.2
|
|
|
|
|
|
|
|
|
|
|
|
10.10#
|
|
Form of Option Award Agreement between Prothena Corporation plc and Registrant’s Named Executive Officers (used beginning January 29, 2013 until February 4, 2014)
|
|
S-8
|
|
333-196572
|
6/6/2014
|
99.3
|
|
|
|
|
|
|
|
|
|
|
|
10.11#
|
|
Form of Option Award Agreement between Prothena Corporation plc and Registrant’s Named Executive Officers (used beginning February 4, 2014)
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
10.12#
|
|
Prothena Biosciences Inc Amended and Restated Severance Plan
|
|
10-K
|
|
001-35676
|
3/29/2013
|
10.12
|
|
|
|
|
|
Previously Filed
|
|
||||
Exhibit
No.
|
|
Description
|
|
Form
|
|
File No.
|
Filing Date
|
Exhibit
|
Filed Herewith
|
|
|
|
|
|
|
|
|
|
|
10.13#
|
|
Prothena Corporation plc Incentive Compensation Plan
|
|
8-K
|
|
001-35676
|
12/21/2012
|
10.6
|
|
|
|
|
|
|
|
|
|
|
|
10.14
|
|
License Agreement, dated as of December 31, 2008, between the University of Tennessee Research Foundation and Elan Pharmaceuticals, Inc.
|
|
10/A
|
|
001-35676
|
11/30/2012
|
10.14
|
|
|
|
|
|
|
|
|
|
|
|
10.15#
|
|
Employment Agreement, dated January 22, 2013, between Prothena Biosciences Inc and Dale B. Schenk
|
|
8-K
|
|
001-35676
|
1/25/2013
|
10.1
|
|
|
|
|
|
|
|
|
|
|
|
10.16#
|
|
Offer letter, dated March 20, 2013, between Prothena Biosciences Inc and Tran B. Nguyen
|
|
8-K
|
|
001-35676
|
3/28/2013
|
10.1
|
|
|
|
|
|
|
|
|
|
|
|
10.17#
|
|
Offer letter, dated December 22, 2012, between Prothena Biosciences Inc and Gene G. Kinney
|
|
10-K
|
|
001-35676
|
3/29/2013
|
10.18
|
|
|
|
|
|
|
|
|
|
|
|
10.18#
|
|
Offer letter, dated March 19, 2013, between Prothena Biosciences Inc and Martin Koller
|
|
8-K
|
|
001-35676
|
3/28/2013
|
10.2
|
|
|
|
|
|
|
|
|
|
|
|
10.19#
|
|
Offer letter, dated December 14, 2012, between Prothena Biosciences Inc and Tara Nickerson
|
|
10-K
|
|
001-35676
|
3/29/2013
|
10.2
|
|
|
|
|
|
|
|
|
|
|
|
10.20#
|
|
Promotion letter, dated February 5, 2014, between Prothena Biosciences Inc and Tara Nickerson
|
|
8-K
|
|
001-35676
|
3/3/2014
|
10.1
|
|
|
|
|
|
|
|
|
|
|
|
10.21#
|
|
Offer letter, dated April 19, 2013, between Prothena Biosciences Inc and Karin L. Walker
|
|
8-K
|
|
001-35676
|
5/22/2013
|
10.1
|
|
|
|
|
|
|
|
|
|
|
|
10.22#
|
|
Offer letter, dated April 11, 2014, between Prothena Biosciences Inc and A. W. Homan
|
|
10-Q
|
|
001-35676
|
8/5/2014
|
10.5
|
|
|
|
|
|
|
|
|
|
|
|
21.1
|
|
List of Subsidiaries
|
|
|
|
|
|
|
X
|
|
|
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23.1
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Consent of KPMG LLP, independent registered public accounting firm
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X
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24.1
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Power of Attorney
(see signature page hereto)
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X
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31.1
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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
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X
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31.2
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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
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X
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32.1*
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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
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X
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Previously Filed
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||||
Exhibit
No.
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Description
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Form
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File No.
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Filing Date
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Exhibit
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Filed Herewith
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101.INS+
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XBRL Instance Document
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X
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101.SCH+
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XBRL Taxonomy Extension Schema Document
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X
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101.CAL+
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XBRL Taxonomy Extension Calculation Linkbase Document
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X
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101.DEF+
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XBRL Taxonomy Extension Definition Linkbase Document
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X
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101.LAB+
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XBRL Taxonomy Extension Label Linkbase Document
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X
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101.PRE+
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XBRL Taxonomy Extension Presentation Linkbase Document
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X
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*
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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 , 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 , except as otherwise specifically stated in such filing.
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#
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Indicates management contract or compensatory plan or arrangement.
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†
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Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and this exhibit has been filed separately with the SEC.
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+
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XBRL information is furnished and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933, as amended, and Section 18 of the Securities Exchange Act of 1934, as amended, 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.
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Granted to:
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[ ]
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Grant Date:
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[ ]
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Shares subject to the Option:
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[ ]
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Exercise Price per Share:
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$[ ]
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Expiration Date:
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[ ]
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Vesting Start Date:
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[ ]
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Vesting Schedule:
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[ ]
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Nonstatutory Stock Option
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This Option is not intended to be an incentive stock option under section 422 of the Internal Revenue Code and will be interpreted accordingly.
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Vesting
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Your right to exercise this Option vests in increments over the [ ] period, commencing on the Vesting Start Date, as shown on the cover sheet. The percentage of the total number of Shares for which this Option will vest and become exercisable is as follows:
[ ]
The vesting will be cumulative and will not exceed 100% of the Shares subject to the Option. If the vesting results in fractional Shares, the number of Shares that vests on the relevant vesting date will be rounded down to the nearest whole number.
Except as otherwise provided in the Plan, the entire Option vests and becomes exercisable if (i) within twenty-four (24) months following a Change in Control, your employment with the Company or one of its Subsidiaries is terminated for any reason other than Cause (as defined below) or you resign for Good Reason (as defined below) (such a resignation or termination being hereinafter referred to as an “
Involuntary Termination
”); (ii) you die while you are still an employee of the Company or a Subsidiary, as applicable; or (iii) your service as an employee of the Company or a Subsidiary, as applicable, terminates because of your Total and Permanent Disability (as defined below). In addition, except as otherwise provided above or in the Plan, the number of Shares subject to the Option that would have vested and become exercisable had you remained employed for the [ ] month period following an Involuntary Termination shall become vested and exercisable as of the date of your Involuntary Termination.
As used herein, and except as otherwise defined in an employment agreement between you and the Company or one of its Subsidiaries to the extent applicable, “Cause” shall mean any of the following: (a) your willful breach, habitual neglect, or poor performance of your job duties and responsibilities, as determined by the Company in its sole discretion; (b) your conviction (or the entry of a guilty plea or plea of
nolo contendre
) of any crime, excluding minor traffic offenses; (c) your commission of an act of dishonesty or breach of fiduciary duty; (d) your commission of a material violation of any of the personnel policies of the Company or a Subsidiary, as applicable, including but not limited to, violations of the Company’s confidentiality or stock trading policies or its policies against any form of harassment; or (e) any action or omission by you, which, as reasonably determined by the Company, is contrary to the business interest, reputation or goodwill of the Company or a Subsidiary.
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As used herein, and except as otherwise defined in an employment agreement between you and the Company or one of its Subsidiaries to the extent applicable, “Good Reason” means (a) a material diminution in your authority, duties or responsibilities or a material diminution in your total base compensation (in each case, as determined by the Company in its sole discretion), or (b) that your primary job site is relocated and your new location increases your commute between home and work by at least thirty (30) miles (however, this does not apply to field-based sales representatives or similar field-based positions) or in the Company’s reasonable opinion, the new location requires that you move your home to a new location at least thirty (30) miles away from your home immediately prior to the change.
In order to receive the benefits of a resignation for “Good Reason”, you must provide your employer with written notice within ninety (90) days after the occurrence of such event and the employer shall then have thirty (30) days to cure such event. If the employer does not cure the event giving rise to Good Reason, your employment will terminate on the first day immediately following the end of thirty (30) day cure period.
Except as provided above or as otherwise provided in a written employment agreement between you and the Company or one of its Subsidiaries, all Shares will cease vesting as of the date your service with the Company or a Subsidiary, as applicable, has terminated for any reason.
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Term
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Your Option will expire in any event at the close of business at the Company’s registered office on the [ ] anniversary of the Grant Date, as shown on the cover sheet. (It will expire earlier if your service with the Company or a Subsidiary, as applicable, terminates - as described below.)
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Death
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If you die prior to expiration of this Option, then your right to purchase vested Shares under this Option will expire at the close of business at the Company’s registered office on the date that is twelve (12) months after the date of death (or on the [ ] anniversary of the Grant Date, if earlier). During that twelve (12) month period, your estate or heirs may exercise this Option.
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Disability
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If your service as an employee of the Company or a Subsidiary, as applicable, terminates because of your Total and Permanent Disability, then your right to purchase vested Shares under this Option will expire at the close of business at the Company’s registered office on the date that is twelve (12) months after your termination date (or on the [ ] anniversary of the Grant Date, if earlier). “Total and Permanent Disability” means that you are unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or which has lasted, or can be expected to last, for a continuous period of not less than one year.
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Involuntary Termination
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If your service as an employee of the Company or a Subsidiary, as applicable, terminates by reason of an Involuntary Termination, then your right to purchase vested Shares under this Option will expire at the close of business at the Company’s registered office on the date that is [ ]
months after your termination date (or on the [ ] anniversary of the Grant Date, if earlier).
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Other Termination
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If your service as an employee of the Company or a Subsidiary, as applicable, terminates for any reason other than those set forth in the immediately preceding three paragraphs, then your right to purchase vested Shares under this Option will expire at the close of business at the Company’s registered office on the 90th day after your termination date (or on the [ ] anniversary of the Grant Date, if earlier).
The Company determines when your service with the Company or a Subsidiary, as applicable, terminates for this purpose.
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Leaves of Absence
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For purposes of this Option, your service does not terminate when you go on a military leave, a sick leave or another
bona fide
leave of absence, if the leave was approved by the Company in writing. But your service will be treated as terminating ninety (90) days after you went on leave, unless your right to return to active work is guaranteed by law or by a contract. Your service terminates, in any event, when the approved leave ends, unless you immediately return to active work.
The Company determines which leaves count for this purpose.
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Restrictions on Exercise
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The Company will not permit you to exercise this Option if the issuance of Shares at that time would violate any law, regulation or Company policy.
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Notice of Exercise
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When you wish to exercise this Option, you must complete and execute such documents, if any, and complete such processes, that the Company or a securities broker approved by the Company may require to accomplish the Option exercise (“Notice of Exercise”).
If someone else wants to exercise this Option after your death, that person must prove to the Company’s satisfaction that he or she is entitled to do so.
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Form of Payment
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When you submit your Notice of Exercise, you must include payment of the exercise price for the Shares you are purchasing. Payment may be made in one (or a combination of both) of the following forms:
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- Your personal check, a cashier’s check or a money order.
- Irrevocable directions to a securities broker approved by the Company to sell your Shares subject to the Option and to deliver all or a portion of the sale proceeds to the Company in payment of the exercise price. (The balance of the sale proceeds, if any, less withholding taxes, will be delivered to you.) The directions must be given by signing forms, if any, provided by the Company or the securities broker.
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Taxes
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You will not be allowed to exercise this Option unless you make acceptable arrangements to pay any taxes that may be due as a result of the Option exercise.
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Restrictions on Resale
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By signing this Agreement, you agree not to sell any Shares received upon exercise of the Option at a time when applicable laws, regulations or Company policies prohibit a sale.
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Transfer of Option
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Prior to your death, only you may exercise this Option. You cannot transfer or assign this Option. For instance, you may not sell this Option or use it as security for a loan. If you attempt to do any of these things, this Option will immediately become invalid. You may, however, dispose of this Option in your will.
Regardless of any marital property settlement agreement, the Company or a securities broker, as applicable, is not obligated to honor a Notice of Exercise from your former spouse, nor is the Company or the securities broker obligated to recognize your former spouse’s interest in your Option in any other way.
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Retention Rights
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Neither your Option nor this Agreement gives you the right to be retained by the Company or any Subsidiary in any capacity. The Company and its Subsidiaries reserve the right to terminate your service at any time, with or without Cause.
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Shareholder Rights
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You, or your estate or heirs, have no rights as a shareholder of the Company until a proper Notice of Exercise has been submitted and the exercise price has been tendered. No adjustments are made for dividends or other rights if the applicable record date occurs before a proper Notice of Exercise has been submitted and the exercise price has been tendered, except as described in the Plan.
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Adjustments
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In the event of a stock split, a stock dividend or a similar change in Company stock, the number of Shares covered by this Option and the exercise price per Share may be adjusted pursuant to the Plan. In the event where the Company is a party to a merger, this Option will be handled in accordance with the Plan.
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Electronic Communications
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You agree to contract electronically regarding your participation in the Plan and to the receipt of electronic notifications, documents, payments or other communications from the Company in connection with the Plan, to the normal electronic mail address used by you for the purposes of your employment or such other address as may be from time to time notified for that purpose by you to the Company.
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Severability
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All the terms and provisions of this Agreement are distinct and severable, and if any term or provision is held unenforceable, illegal or void in whole or in part by any court, regulatory authority or other competent authority it shall to that extent be deemed not to form part of this Agreement, and the enforceability, legality and validity of the remainder of this Agreement will not be affected; if any invalid, unenforceable or illegal provision would be valid, enforceable or legal if some part of it were deleted, the provision shall apply with whatever modification is necessary to make it valid, enforceable and legal.
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Applicable Law
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This Agreement will be interpreted and enforced under the laws of Ireland.
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The Plan and Other Agreements
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The text of the Plan and any amendments thereto are incorporated in this Agreement by reference.
This Agreement and the Plan constitute the entire understanding between you and the Company regarding this Option. Any prior agreements, commitments or negotiations concerning this Option are superseded.
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Subsidiary Name
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Jurisdiction of Incorporation or Organization
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Prothena Biosciences Limited (formerly Neotope Biosciences Limited)
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Ireland
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Prothena Therapeutics Limited (formerly Onclave Therapeutics Limited)
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Ireland
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Prothena Biosciences Inc
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Delaware
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1.
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I have reviewed this Annual Report on Form 10-K of Prothena Corporation plc;
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2.
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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;
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3.
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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;
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4.
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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:
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(a)
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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;
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(b)
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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;
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(c)
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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
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(d)
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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
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5.
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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):
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(a)
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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
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(b)
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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.
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Date:
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March 12, 2015
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/s/ Dale B. Schenk
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Dale B. Schenk
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President and Chief Executive Officer
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(Principal Executive Officer)
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1.
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I have reviewed this Annual Report on Form 10-K of Prothena Corporation plc;
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2.
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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;
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3.
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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;
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4.
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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:
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(a)
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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;
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(b)
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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;
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(c)
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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
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(d)
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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
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5.
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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):
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(a)
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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
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(b)
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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.
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Date:
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March 12, 2015
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/s/ Tran B. Nguyen
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Tran B. Nguyen
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Chief Financial Officer
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(Principal Financial Officer)
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1.
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The Company’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2014
, 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
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2.
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Date:
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March 12, 2015
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/s/ Dale B. Schenk
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Dale B. Schenk
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President and Chief Executive Officer
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(Principal Executive Officer)
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/s/ Tran B. Nguyen
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Tran B. Nguyen
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Chief Financial Officer
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(Principal Financial Officer)
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