Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Nov. 04, 2016 | |
Document And Entity Information | ||
Entity Registrant Name | Ophthotech Corp. | |
Entity Central Index Key | 1,410,939 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 35,697,696 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 |
Unaudited Balance Sheets
Unaudited Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Current assets | ||
Cash and cash equivalents | $ 165,604 | $ 221,861 |
Available for sale securities | 155,552 | 74,731 |
Income tax receivable | 24,265 | 3,421 |
Due from Novartis Pharma AG | 6 | 4,389 |
Prepaid expenses and other current assets | 1,514 | 2,083 |
Total current assets | 346,941 | 306,485 |
Available for sale securities | 0 | 95,298 |
Property and equipment, net | 3,174 | 3,466 |
Deferred tax assets | 0 | 23,113 |
Other assets | 470 | 489 |
Total assets | 350,585 | 428,851 |
Current liabilities | ||
Accrued research and development expenses | 40,017 | 18,820 |
Accounts payable and accrued expenses | 10,389 | 12,018 |
Deferred revenue | 6,776 | 6,667 |
Total current liabilities | 57,182 | 37,505 |
Deferred revenue, long-term | 204,992 | 206,399 |
Royalty purchase liability | 125,000 | 125,000 |
Total liabilities | 387,174 | 368,904 |
Stockholders’ equity (deficit) | ||
Preferred stock - $0.001 par value, 5,000,000 shares authorized, no shares issued or outstanding | 0 | 0 |
Common stock - $0.001 par value, 200,000,000 shares authorized, 35,649,301 and 35,196,567 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | 36 | 35 |
Additional paid-in capital | 496,210 | 465,924 |
Accumulated deficit | (532,676) | (405,539) |
Accumulated other comprehensive loss | (159) | (473) |
Total stockholders’ equity (deficit) | (36,589) | 59,947 |
Total liabilities and stockholders’ equity (deficit) | $ 350,585 | $ 428,851 |
Unaudited Balance Sheets (Paren
Unaudited Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 35,649,301 | 35,196,567 |
Common stock, shares outstanding (in shares) | 35,649,301 | 35,196,567 |
Unaudited Statements of Operati
Unaudited Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Income Statement [Abstract] | ||||
Collaboration revenue | $ 1,668 | $ 3,448 | $ 45,587 | $ 46,723 |
Operating expenses: | ||||
Research and development | 50,854 | 40,479 | 136,886 | 97,095 |
General and administrative | 12,024 | 10,412 | 37,209 | 31,955 |
Total operating expenses | 62,878 | 50,891 | 174,095 | 129,050 |
Loss from operations | (61,210) | (47,443) | (128,508) | (82,327) |
Interest income | 409 | 320 | 1,301 | 584 |
Other income (loss) | (20) | 19 | (88) | 46 |
Loss before income tax (benefit) provision | (60,821) | (47,104) | (127,295) | (81,697) |
Income tax (benefit) provision | 70 | (7,531) | (158) | (11,629) |
Net loss | $ (60,891) | $ (39,573) | $ (127,137) | $ (70,068) |
Net loss per common share: | ||||
Basic and diluted (in dollars per share) | $ (1.71) | $ (1.14) | $ (3.59) | $ (2.03) |
Weighted average common shares outstanding: | ||||
Basic and diluted (in shares) | 35,594 | 34,782 | 35,415 | 34,432 |
Unaudited Statements of Compreh
Unaudited Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (60,891) | $ (39,573) | $ (127,137) | $ (70,068) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available for sale securities, net of tax | (41) | 55 | 314 | 144 |
Other comprehensive income (loss) | (41) | 55 | 314 | 144 |
Comprehensive loss | $ (60,932) | $ (39,518) | $ (126,823) | $ (69,924) |
Unaudited Statements of Cash Fl
Unaudited Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Operating Activities | ||
Net loss | $ (127,137) | $ (70,068) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation | 539 | 535 |
Amortization of premium and discounts on investment securities | 454 | 2,517 |
Gain on sale of marketable securities | 0 | (53) |
Deferred income taxes | 22,916 | (11,722) |
Share-based compensation | 24,889 | 18,474 |
Changes in operating assets and liabilities: | ||
Due from Novartis Pharma AG | 4,383 | 960 |
Income tax receivable | (20,844) | 0 |
Prepaid expense and other current assets | 569 | 3,271 |
Accrued interest receivable | 157 | 320 |
Security deposits | 0 | (185) |
Other assets | 19 | 65 |
Accrued research and development expenses | 21,197 | 12,162 |
Accounts payable and accrued expenses | (1,629) | (857) |
Deferred revenue | (1,298) | 5,086 |
Net cash used in operating activities | (75,785) | (39,495) |
Investing Activities | ||
Purchase of marketable securities | (48,123) | (382,921) |
Sale of marketable securities | 0 | 367,043 |
Maturities of marketable securities | 62,500 | 266,000 |
Purchase of property and equipment | (247) | (1,576) |
Proceeds from sale of assets | 0 | 6 |
Net cash provided by investing activities | 14,130 | 248,552 |
Financing Activities | ||
Proceeds from stock option/warrant exercises | 5,398 | 6,024 |
Net cash provided by financing activities | 5,398 | 6,024 |
Net change in cash and cash equivalents | (56,257) | 215,081 |
Cash and cash equivalents | ||
Beginning of period | 221,861 | 39,814 |
End of period | 165,604 | 254,895 |
Supplemental disclosures of non-cash information related to investing activities | ||
Change in unrealized gains on available for sale securities, net of tax | $ 314 | $ 144 |
Business
Business | 9 Months Ended |
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business | 1. Business Description of Business and Organization Ophthotech Corporation (the “Company” or “Ophthotech”) was incorporated on January 5, 2007, in Delaware. The Company is a biopharmaceutical company specializing in the development of novel therapeutics to treat diseases of the back of the eye, with a focus on developing therapeutics for age-related macular degeneration, or AMD. The Company’s most advanced product candidate is Fovista ® (pegpleranib), which is an anti-platelet derived growth factor (“PDGF”) aptamer that is in Phase 3 clinical development for use in combination with anti-vascular endothelial growth factor (“VEGF”) drugs that represent the current standard of care for the treatment of wet AMD. The Company has completed one Phase 1 and one Phase 2b clinical trial of Fovista administered in combination with the anti-VEGF drug Lucentis ® (ranibizumab), has completed patient enrollment for two Phase 3 clinical trials of Fovista administered in combination with Lucentis and has completed enrollment in a third Phase 3 clinical trial evaluating Fovista in combination with Eylea ® (aflibercept) or Avastin ® (bevacizumab). The Company has completed enrollment in two additional Phase 2a clinical trials of Fovista administered in combination with anti-VEGF drugs (Lucentis, Eylea or Avastin), one of which is studying the potential of Fovista to reduce subretinal fibrosis in wet AMD patients and the other of which is investigating the optimized regimen of Fovista in combination with anti-VEGF drugs, as well as the potential of Fovista to reduce the treatment burden for wet AMD patients. The Company is also developing its product candidate Zimura ® (avacincaptad pegol), an inhibitor of complement factor C5, as a monotherapy for the treatment of patients with geographic atrophy (“GA”), a form of dry AMD, as well as in combination with anti-VEGF drugs for the treatment of wet AMD. The Company is also investigating the potential of an ophthalmic formulation for tivozanib, a small molecule VEGF tyrosine kinase inhibitor for which the Company has an option for a license. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited financial information as of September 30, 2016 and for the three and nine months ended September 30, 2016 and 2015 has been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The December 31, 2015 Balance Sheet was derived from the Company’s audited financial statements. These interim financial statements should be read in conjunction with the notes to the financial statements contained in the Company’s Annual Report on Form 10-K (“Annual Report”) for 2015 , as filed with the SEC on February 26, 2016. In the opinion of management, the unaudited financial information as of September 30, 2016 and for the three and nine months ended September 30, 2016 and 2015 , reflects all adjustments, which are normal recurring adjustments, necessary to present a fair statement of financial position, results of operations and cash flows. The results of operations for the three and nine months ended September 30, 2016 and 2015 are not necessarily indicative of the operating results for the full fiscal year or any future period. Use of Estimates The preparation of financial statements and related disclosures in conformity with GAAP requires management to make estimates and judgments that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s Balance Sheets and the amount of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, accounting for research and development costs, revenue recognition, accounting for share-based compensation and accounting for income taxes. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of 90 days or less when purchased to be cash equivalents. The carrying amounts reported in the Balance Sheets for cash and cash equivalents are valued at cost, which approximates their fair value. Available for Sale Securities The Company considers securities with original maturities of greater than 90 days when purchased to be available for sale securities. Available for sale securities with original maturities of greater than one year are recorded as non-current assets. Available for sale securities are recorded at fair value and unrealized gains and losses are recorded within accumulated other comprehensive income (loss). The estimated fair value of the available for sale securities is determined based on quoted market prices or rates for similar instruments. In addition, the cost of debt securities in this category is adjusted for amortization of premium and accretion of discount to maturity. The Company evaluates securities with unrealized losses to determine whether such losses, if any, are other than temporary. Revenue Recognition Collaboration Revenue Prior to 2014, the Company had not generated any revenue. In May 2014, the Company received an upfront payment of $200.0 million in connection with its licensing and commercialization agreement with Novartis Pharma AG, (the “Novartis Agreement”), which has not been recorded as revenue due to certain contingencies associated with the payment. In each of September 2014 and March 2015, the Company achieved a $50.0 million enrollment-based milestone, and in June 2016, the Company achieved a $30.0 million enrollment-based milestone, for an aggregate total of $130.0 million , under the Novartis Agreement. The Company uses the relative selling price method to allocate arrangement consideration to the Company’s performance obligations under the Novartis Agreement. Below is a summary of the components of the Company’s collaboration revenue for the three and nine months ended September 30, 2016 and 2015 : Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 License revenue $ — $ — $ 22,937 $ 38,083 Research and development activity revenue 1,664 1,594 8,089 6,768 API transfer revenue — 1,851 14,545 1,851 Joint operating committee revenue 4 3 16 21 Total collaboration revenue $ 1,668 $ 3,448 $ 45,587 $ 46,723 In the future, the Company may generate additional revenues from a combination of product sales and license fees, milestone payments, research and development activity-related payments, payments for manufactured material and royalties in connection with the Novartis Agreement. The terms of this agreement and other potential collaboration or commercialization agreements the Company may enter into generally contain multiple elements, or deliverables, which may include (i) licenses, or options to obtain licenses, to certain of the Company’s technology and products, (ii) research and development activities to be performed on behalf of the collaborative partner, and (iii) in certain cases, services in connection with the manufacturing of preclinical, clinical and commercial material. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; milestone payments; payments for manufactured material; and royalties on future product sales. When evaluating multiple element arrangements, the Company considers whether the deliverables under the arrangement represent separate units of accounting. This evaluation requires subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. In determining the units of accounting, management evaluates certain criteria, including whether the deliverables have standalone value, based on the relevant facts and circumstances for each arrangement. The consideration received is allocated among the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria are applied to each of the separate units. The Company determines the estimated selling price for deliverables within each agreement using vendor-specific objective evidence (“VSOE”) of selling price, if available, third-party evidence (“TPE”) of selling price if VSOE is not available, or best estimate of selling price (“BESP”) if neither VSOE nor TPE is available. Determining the best estimate of selling price for a deliverable requires significant judgment. The Company uses BESP to estimate the selling price for licenses to the Company’s proprietary technology, since the Company often does not have VSOE or TPE of selling price for these deliverables. In those circumstances where the Company utilizes BESP to determine the estimated selling price of a license to the Company’s proprietary technology, the Company considers market conditions as well as entity-specific factors, including those factors contemplated in negotiating the agreements as well as internally developed models that include assumptions related to the market opportunity, estimated development costs, probability of success and the time needed to commercialize a product candidate that is subject to the license. In validating the Company’s BESP, the Company evaluates whether changes in the key assumptions used to determine the BESP will have a significant effect on the allocation of arrangement consideration among multiple deliverables. When management believes the license to its intellectual property and products has stand-alone value, the Company generally recognizes revenue attributed to the license upon delivery. When management believes such a license does not have stand-alone value from the other deliverables to be provided in the arrangement, the Company generally recognizes revenue attributed to the license on a straight-line basis over the Company’s contractual or estimated performance period, which is typically the term of the Company’s research and development obligations. If management cannot reasonably estimate when the Company’s performance obligation ends, then revenue is deferred until management can reasonably estimate when the performance obligation ends. The periods over which revenue should be recognized are subject to estimates by management and may change over the course of the research and development agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. At the inception of arrangements that include milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance, and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. The Company evaluates factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. The Company aggregates its milestones into three categories: (i) clinical and development milestones, (ii) regulatory milestones, and (iii) commercial milestones. Clinical and development milestones are typically achieved when a product candidate advances into a defined phase of clinical research or completes such phase or when a contractually specified clinical trial enrollment target is attained. Regulatory milestones are typically achieved upon acceptance of the submission of an application for marketing approval for a product candidate or upon approval to market the product candidate by the U.S. Food and Drug Administration (the “FDA”) or other regulatory authorities. Commercial milestones are typically achieved when an approved pharmaceutical product reaches certain defined levels of net sales by the licensee, such as when a product first achieves global sales or annual sales of a specified amount. Revenues from clinical and development and regulatory milestone payments, if the milestones are deemed substantive and the milestone payments are nonrefundable, are recognized upon successful accomplishment of the milestones. With regard to the Novartis Agreement, the Company has concluded that the clinical and development milestones and certain reimbursement milestones are not substantive and that the marketing approval milestones are substantive. Milestone payments received that are not considered substantive are included in the allocable arrangement consideration and are recognized as revenue in proportion to the relative selling price allocation established at the inception of the arrangement. Revenues from commercial milestone payments are accounted for as royalties and are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. Concentration of Credit Risk The Company’s financial instruments that are exposed to concentration of credit risk consist primarily of cash and cash equivalents and available for sale securities. The Company maintains its cash in bank accounts, which generally exceed federally insured limits. The Company maintains its cash equivalents in investments in money market funds and, at times, in U.S. Treasury securities and investment-grade corporate debt securities with original maturities of 90 days or less. The Company’s available for sale securities are also invested in U.S. Treasury securities and investment-grade corporate debt securities. The Company believes it is not exposed to significant credit risk on its cash, cash equivalents and available for sale securities. Concentration of Suppliers The Company currently relies exclusively upon a single third-party manufacturer to provide supplies of the active pharmaceutical ingredient, or API, for both Fovista and Zimura. The Company also engages a single third-party manufacturer to provide fill/finish services for clinical supplies of both Fovista and Zimura. In addition, the Company currently relies exclusively upon Nektar Therapeutics, or Nektar, to supply it with a proprietary polyethylene glycol, or PEG, reagent for Fovista under a manufacturing and supply agreement. PEG reagent is a chemical the Company uses to modify the chemically synthesized aptamer in Fovista. The PEG reagent made by Nektar is proprietary to Nektar. The Company obtains a different proprietary PEG reagent used to modify the chemically synthesized aptamer in Zimura from a different supplier on a purchase order basis. Furthermore, the Company and its contract manufacturers currently rely upon sole-source suppliers of certain raw materials and other specialized components of production used in the manufacture and fill/finish of each of Fovista and Zimura. If the Company’s third-party manufacturers or fill/finish service providers should become unavailable to the Company for any reason, including as a result of capacity constraints, financial difficulties or insolvency, the Company believes that there are a limited number of potential replacement manufacturers, and the Company likely would incur added costs and delays in identifying or qualifying such replacements. Foreign Currency Translation The Company considers the U.S. dollar to be its functional currency. Expenses denominated in foreign currencies are translated at the exchange rate on the date the expense is incurred. The effect of exchange rate fluctuations on translating foreign currency assets and liabilities into U.S. dollars is included in the Statements of Operations. Foreign exchange transaction gains and losses are included in the results of operations and are not material in the Company’s financial statements. Financial Instruments Cash equivalents and available for sale securities are reflected in the accompanying financial statements at fair value. The carrying amount of accounts payable and accrued expenses, including accrued research and development expenses, approximates fair value due to the short-term nature of those instruments. Property and Equipment Property and equipment, which consists mainly of manufacturing and clinical equipment, furniture and fixtures, computers, software, and other office equipment, and leasehold improvements, are carried at cost less accumulated depreciation. Depreciation is computed over the estimated useful lives of the respective assets, generally three to ten years, using the straight-line method. Research and Development Research and development expenses primarily consist of costs associated with the manufacturing, development and clinical testing of Fovista and Zimura as well as costs associated with the preclinical development of other product candidates and formulations. Research and development expenses consist of: • external research and development expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”) and other vendors and contract manufacturing organizations (“CMOs”) for the production of drug substance and drug product; and • employee-related expenses, including salaries, benefits and share-based compensation expense. Research and development expenses also include costs of acquired product licenses and related technology rights where there is no alternative future use, costs of prototypes used in research and development, consultant fees and amounts paid to collaborative partners. All research and development expenses are charged to operations as incurred in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic, or ASC, 730, Research and Development . The Company accounts for non-refundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received, rather than when the payment is made. Income Taxes The Company utilizes the liability method of accounting for deferred income taxes, as set forth in ASC 740, Income Taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. The Company incurred U.S. federal net operating losses (“NOLs”) in each year from its inception in 2007 through 2013 and utilized these NOLs in 2014. Additionally, the Company incurred a U.S. federal net operating loss in 2015 that has been carried back to 2014. Accordingly, all tax years since 2007 are subject to potential tax examination. In the second quarter of 2016, the Internal Revenue Service began an examination of the Company’s 2014 corporate income tax return. To date, no findings or assessments have been received by the Company. Share-Based Compensation The Company follows the provisions of ASC 718, Compensation—Stock Compensation, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and non-employee directors, including employee stock options, restricted stock units (“RSUs”) and the option granted to employees to purchase shares under the 2016 Employee Stock Purchase Plan (the “ESPP”). Share-based compensation expense is based on the grant date fair value estimated in accordance with the provisions of ASC 718 and is generally recognized as an expense over the requisite service period, net of forfeitures. For grants containing performance-based vesting provisions, expense is recognized over the estimated achievement period. Stock Options The Company estimates the fair value of stock options granted to employees and non-employee directors on the date of grant using the Black-Scholes option-pricing model. Due to the lack of trading history, the Company’s computation of stock-price volatility is based on the volatility rates of comparable publicly held companies over a period equal to the expected term of the options granted by the Company. The Company’s computation of expected term is determined using the “simplified” method, which is the midpoint between the vesting date and the end of the contractual term. The Company believes that it does not have sufficient reliable exercise data in order to justify the use of a method other than the “simplified” method of estimating the expected exercise term of employee stock option grants. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends to stockholders and has no current intentions to pay cash dividends. The risk-free interest rate is based on the zero-coupon U.S. Treasury yield at the date of grant for a term equivalent to the expected term of the option. For stock options granted as consideration for services rendered by consultants, the Company recognizes expense in accordance with the requirements of ASC 505-50, Equity Based Payments to Non-Employees . Consultant stock option grants are recorded as an expense over the vesting period of the underlying stock options. At the end of each financial reporting period prior to vesting, the value of these options, as calculated using the Black-Scholes option-pricing model, will be re-measured using the fair value of the Company’s common stock and the non-cash expense recognized during the period will be adjusted accordingly. Since the fair value of options granted to consultants is subject to change in the future, the amount of the future expense will include fair value re-measurements until the stock options are fully vested. RSUs The Company estimates the fair value of RSUs granted to employees using the closing market price of the Company’s common stock on the date of grant. ESPP In April 2016, the board of directors adopted the ESPP pursuant to which the Company may sell up to an aggregate of 1,000,000 shares of common stock. The ESPP was approved by the Company’s stockholders in June 2016. The ESPP is considered compensatory and the fair value of the discount and look back provision are estimated using the Black-Scholes option-pricing model and recognized over the six month withholding period prior to purchase. Share-based compensation expense includes expenses related to stock options and RSUs granted to employees, non-employee directors and consultants, as well as the option granted to employees to purchase shares under the ESPP, all of which have been reported in the Company’s Statements of Operations as follows: Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 Research and development $ 5,664 $ 5,116 $ 16,732 $ 12,535 General and administrative 2,584 1,925 8,157 5,939 Total $ 8,248 $ 7,041 $ 24,889 $ 18,474 Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2014-9, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-9”). ASU 2014-9 outlines a new, single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. This new revenue recognition model provides a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services. The FASB subsequently issued additional clarifying standards to address issues arising from implementation of the new revenue standard, including a one-year deferral of the effective date for the new revenue standard. Public companies should now apply the guidance in ASU 2014-9 to annual reporting periods beginning after December 15, 2017 and interim periods within those annual periods. Earlier application is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that annual period. Companies may use either a full retrospective or a modified retrospective approach to adopt ASU 2014-9. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , which defines management’s responsibility to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures if there is substantial doubt about its ability to continue as a going concern. The pronouncement is effective for annual reporting periods ending after December 15, 2016 with early adoption permitted. The adoption of this guidance is not expected to have a significant impact on the Company’s financial statements. In November 2015, the FASB issued ASU 2015-17, Income Taxes (Topic 740) : Balance Sheet Classification of Deferred Taxes , which updated and simplified the presentation of deferred income taxes. Current GAAP requires an entity to separate deferred income tax assets and liabilities into current and non-current amounts in a classified statement of financial position. The requirement results in little or no benefit to users of financial statements because the classification does not generally align with the time period in which the recognized deferred tax amounts are expected to be recovered or settled. To simplify the presentation of deferred income taxes, the amendments in this update require that deferred tax assets and liabilities be classified as noncurrent in a classified statement of financial position. The current requirement that deferred tax assets and liabilities of a tax-paying component of an entity be offset and presented as a single amount is not affected by the amendments in this update. The amendments in this update are effective for financial statements issued for annual periods beginning after December 15, 2016 and interim periods within those annual periods. Earlier application is permitted as of the beginning of an interim or annual reporting period. The Company has elected to adopt this standard retrospectively, effective December 31, 2015. In February 2016, the FASB issued ASU No. 2016-2, Leases (Topic 842) . Under the new guidance, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the commencement date: (1) A lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and (2) A right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. Under the new guidance, lessor accounting is largely unchanged. Certain targeted improvements were made to align, where necessary, lessor accounting with the lessee accounting model and Topic 606, Revenue from Contracts with Customers . The new lease guidance simplified the accounting for sale and leaseback transactions primarily because lessees must recognize lease assets and lease liabilities. Lessees will no longer be provided with a source of off-balance sheet financing. Public business entities should apply the amendments in ASU 2016-2 for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years (i.e., January 1, 2019, for a calendar year entity). Early application is permitted for all public business entities and all nonpublic business entities upon issuance. Lessees (for capital and operating leases) and lessors (for sales-type, direct financing, and operating leases) must apply a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The modified retrospective approach would not require any transition accounting for leases that expired before the earliest comparative period presented. Lessees and lessors may not apply a full retrospective transition approach. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In March 2016, the FASB issued ASU 2016-9, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting . The amendments are intended to improve the accounting for employee share-based payments and affect all organizations that issue share-based payment awards to their employees. Several aspects of the accounting for share-based payment award transactions are simplified, including: ( a ) income tax consequences; ( b ) classification of awards as either equity or liabilities; and ( c ) classification on the statement of cash flows. For public companies, the amendments are effective for annual periods beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted in any interim or annual period. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments , which clarifies the presentation of certain specific cash flow issues in the Statement of cash flows. For public companies, the amendments are effective for annual reporting periods beginning after December 15, 2017, and interim periods within those annual periods and early adoption is permitted. This new guidance is not expected to have a material impact on the Company’s Consolidated Financial Statements. |
Net Loss Per Common Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2016 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | 3. Net Loss Per Common Share Basic and diluted net income (loss) per common share is determined by dividing net income (loss) by the weighted average common shares outstanding during the period. For the periods where there is a net loss, stock options and RSUs have been excluded from the calculation of diluted net loss per common share because their effect would be anti-dilutive. Therefore, the weighted average common shares used to calculate both basic and diluted net loss per common share would be the same. The following table sets forth the computation of basic and diluted net income (loss) per common share for the periods indicated: Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 Basic and diluted net loss per common share calculation: Net loss $ (60,891 ) $ (39,573 ) $ (127,137 ) $ (70,068 ) Weighted average common shares outstanding - basic and diluted 35,594 34,782 35,415 34,432 Net loss per share of common stock - basic and diluted $ (1.71 ) $ (1.14 ) $ (3.59 ) $ (2.03 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted average common shares outstanding for the periods presented, as they would be anti-dilutive: Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 Stock options outstanding 3,423 3,224 3,423 3,224 Restricted stock units 721 285 721 285 Total 4,144 3,509 4,144 3,509 |
Cash, Cash Equivalents and Avai
Cash, Cash Equivalents and Available for Sale Securities | 9 Months Ended |
Sep. 30, 2016 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
Cash, Cash Equivalents and Available for Sale Securities | 4. Cash, Cash Equivalents and Available for Sale Securities The Company considers all highly liquid investments purchased with original maturities of 90 days or less at the date of purchase to be cash equivalents. Cash and cash equivalents included cash of $5.5 million at September 30, 2016 and December 31, 2015 , respectively. Cash and cash equivalents at September 30, 2016 and December 31, 2015 also included $160.1 million and $216.4 million , respectively, of investments in money market funds, U.S. Treasury securities and certain short-term investment-grade corporate debt securities with original maturities of 90 days or less. The Company considers securities with original maturities of greater than 90 days at the date of purchase to be available for sale securities. The Company held available for sale securities with a fair value totaling $155.6 million and $170.0 million at September 30, 2016 and December 31, 2015 , respectively. These available for sale securities consisted of U.S. Treasury securities and investment-grade corporate debt securities. At September 30, 2016 , the Company held available for sale securities of $155.6 million with maturities of less than one year. The Company did not hold any securities with maturities of greater than one year at September 30, 2016 . The Company evaluates securities with unrealized losses, if any, to determine whether such losses are other than temporary. The Company has determined that there were no other than temporary losses in fair value of its investments as of September 30, 2016 . The Company classifies these securities as available for sale, however, the Company does not currently intend to sell its investments and the Company believes it is more likely than not that the Company will recover the carrying value of these investments. Available for sale securities, including carrying value and estimated fair values, are summarized as follows: As of September 30, 2016 Cost Unrealized Gains Unrealized Losses Fair Value U.S. Treasury securities $ 120,280 $ 47 $ (7 ) $ 120,320 Corporate debt securities 35,233 10 (11 ) 35,232 Total $ 155,513 $ 57 $ (18 ) $ 155,552 As of December 31, 2015 Cost Unrealized Gains Unrealized Losses Fair Value U.S. Treasury securities $ 130,507 $ — $ (311 ) $ 130,196 Corporate debt securities 39,995 — (162 ) 39,833 Total $ 170,502 $ — $ (473 ) $ 170,029 The Company’s available for sale securities are reported at fair value on the Company’s Balance Sheets. Unrealized gains (losses) are reported within accumulated other comprehensive income (loss) in the statements of comprehensive income (loss). The cost of securities sold and any realized gains/losses from the sale of available for sale securities are based on the specific identification method. The changes in accumulated other comprehensive income (loss) associated with the unrealized gain (loss) on available for sale securities during the three and nine months ended September 30, 2016 and September 30, 2015 were as follows: Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 Beginning balance $ (118 ) $ 24 $ (473 ) $ (65 ) Current period changes in fair value before reclassifications, net of tax (41 ) 85 314 174 Amounts reclassified from accumulated other comprehensive income (loss), net of tax — (30 ) — (30 ) Total other comprehensive income (loss) (41 ) 55 314 144 Ending balance $ (159 ) $ 79 $ (159 ) $ 79 |
Licensing and Commercialization
Licensing and Commercialization Agreement with Novartis Pharma AG | 9 Months Ended |
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Licensing and Commercialization Agreement with Novartis Pharma AG | 5. Licensing and Commercialization Agreement with Novartis Pharma AG In May 2014, the Company entered into a licensing and commercialization agreement with Novartis Pharma AG (“Novartis”, and such agreement, the “Novartis Agreement”). Under the Novartis Agreement, the Company granted Novartis exclusive rights under specified patent rights, know-how and trademarks controlled by the Company to manufacture, from bulk API supplied by the Company, standalone Fovista products and products combining Fovista with an anti-VEGF drug to which Novartis has rights in a co-formulated product, for the treatment, prevention, cure or control of any human disease, disorder or condition of the eye, and to develop and commercialize those licensed products in all countries outside of the United States (the “Novartis Territory”). The Company has agreed to use commercially reasonable efforts to complete its ongoing pivotal Phase 3 clinical program for Fovista and Novartis has agreed to use commercially reasonable efforts to develop a standalone Fovista product and a co-formulated product containing Fovista and an anti-VEGF drug to which Novartis has rights, as well as a pre-filled syringe presentation of such products and to use commercially reasonable efforts, subject to obtaining marketing approval, to commercialize licensed products in the Novartis Territory in accordance with agreed development and marketing plans. Novartis has also granted the Company options, subject to specified limitations, and to the extent such rights are controlled by Novartis, to obtain exclusive rights from Novartis to develop and commercialize in the United States the co-formulated and pre-filled syringe products developed by Novartis. The Company and Novartis have each granted the other options, subject to specified limitations, to obtain access to study data from certain clinical trials of licensed products that the Company or Novartis may conduct, including for use by the other in regulatory filings in its territory. The Company has agreed to exclusively supply Novartis, and Novartis has agreed to exclusively purchase from the Company, its clinical and commercial requirements for the bulk API for Fovista for use in licensed products in the Novartis Territory. The Company has agreed not to commercialize any product comprising Fovista or any other anti-PDGF product in the ophthalmic field in the Novartis Territory. Novartis paid the Company a $200.0 million upfront fee upon execution of the Novartis Agreement. Novartis also paid the Company $50.0 million upon the achievement of each of two patient enrollment-based milestones, and $30.0 million upon the achievement of a third, and final, enrollment-based milestone, for an aggregate of $130.0 million . Under the terms of the Novartis Agreement, Novartis is also obligated to pay up to an aggregate of an additional $300.0 million upon achievement of specified regulatory milestones, including marketing approval and reimbursement approval in certain countries in the Novartis Territory. In addition, Novartis has agreed to pay the Company up to an aggregate of an additional $400.0 million if Novartis achieves specified sales milestones in the Novartis Territory. Novartis is also obligated to pay the Company royalties with respect to standalone Fovista products and combination Fovista products that Novartis successfully commercializes. The Company will receive royalties at a mid-thirties percentage of net sales of standalone Fovista products and a royalty of approximately equal value for sales of combination Fovista products. Such royalties are subject to customary deductions, credits, and reductions for lack of patent coverage or market exclusivity. Novartis’s obligation to pay such royalties will continue on a licensed product-by-licensed product and country-by-country basis until Novartis’s last actual commercial sale of such licensed product in such country. The Company will continue to be responsible for royalties it owes to third parties on sales of Fovista products. Novartis has agreed to pay the Company’s manufacturing costs for clinical supplies and the Company’s manufacturing costs plus a specified percentage margin for commercial supplies of the bulk API for Fovista that the Company supplies to Novartis. If the Company or Novartis exercises each of their respective rights to obtain access to study data from clinical trials conducted by the other party, the party exercising the option will be obligated to pay the other party’s associated past development costs and share with such other party any future associated development costs. If the Company exercises its option to obtain Novartis-controlled rights to develop, manufacture and commercialize any co-formulated Fovista product in the United States, the Company will be obligated to pay a specified percentage of Novartis’s associated past development costs and share with Novartis any future associated development costs. The Company and Novartis will also need to negotiate and agree on financial and other terms that would apply to such rights. If the Company exercises its option to obtain Novartis-controlled rights to develop and commercialize a pre-filled syringe product in the United States, the Company will be obligated to either enter into a supply agreement with Novartis under which the Company will pay Novartis its manufacturing cost plus a specified percentage margin for supplies of Fovista products in pre-filled syringes that Novartis supplies to the Company, or obtain supplies of products in pre-filled syringes from a third-party manufacturer and pay Novartis a low single-digit percentage of the Company’s net sales of such products. The Company has retained control over the design and execution of its pivotal Phase 3 clinical program for Fovista and remains responsible for funding the costs of that program, subject to Novartis’s responsibility to provide Lucentis, an anti-VEGF drug to which Novartis has rights in the Novartis Territory, for use in the Phase 3 trials already initiated and in other Phase 2 and Phase 3 clinical trials in the Novartis Territory initiated following the effective date of the Novartis Agreement. Novartis will have control over, and will be responsible for the costs of, all other clinical trials that may be required to obtain marketing approvals in the Novartis Territory for licensed products under the agreement. Novartis is also responsible for costs associated with co-formulation development, pre-filled syringe development and other development costs in the Novartis Territory, excluding regulatory filing fees in the European Union for the standalone Fovista product, for which the Company will be responsible. The Novartis Agreement, unless earlier terminated by the Company or Novartis, will expire upon the expiration of Novartis’s obligation to pay the Company royalties on net sales of licensed products. The Company and Novartis each may terminate the Novartis Agreement if the other party materially breaches the agreement and does not cure such breach within a specified cure period, if the other party experiences any specified insolvency event, if the other party challenges or assists a third party in challenging the validity or enforceability of certain patent rights controlled by the terminating party, or if the parties are prevented in any manner that materially adversely affects the progression of the development or commercialization of licensed products for a specified period as a result of specified governmental actions. Novartis may terminate the Novartis Agreement at any time without cause, or within a specified period after a change in control of the Company, as defined in the Novartis Agreement, or for specified safety reasons, effective at the end of a specified period following Novartis’s written notice to the Company of Novartis’s election to terminate the agreement. The Company may also terminate the agreement if Novartis determines to seek marketing approval of an alternative anti-PDGF product in the Novartis Territory as more fully described below. If the Company elects to terminate the Novartis Agreement because specified governmental actions prevent the parties from materially progressing the development or commercialization of licensed products as described above, the Company will be required to pay a substantial termination fee. Following any termination, all rights to Fovista that the Company granted to Novartis, including, without limitation, the right to commercialize standalone Fovista products in the Novartis Territory, will revert to the Company, Novartis will perform specified activities in connection with transitioning to the Company the rights and responsibilities for the continued development, manufacture and commercialization of the standalone Fovista product for countries in the Novartis Territory, and the parties will cooperate on an orderly wind down of development and commercialization activities for other licensed products in the Novartis Territory. Novartis has agreed to specified limitations on its ability to in-license, acquire or commercialize any anti-PDGF product that does not contain Fovista (an “Alternative Anti-PDGF Product”) in the Novartis Territory and, to the extent Novartis develops, in-licenses or acquires such a product, to make such product available to the Company in the United States under specified option conditions. If the Company exercises its option, the Company will be obligated to make certain payments to Novartis, including specified milestone and royalty payments. The amounts of such payments will vary based on the product’s stage of clinical development at the time the Company exercises its option, whether the product is a standalone or combination product and whether Novartis exercises an option to co-promote such product in the United States. If Novartis determines to seek marketing approval of an Alternative Anti-PDGF Product in the Novartis Territory, the Company will, subject to specified limitations, have the option to terminate the Novartis Agreement, convert Novartis’s exclusive licenses into non-exclusive licenses, or elect to receive a royalty on sales of such product by Novartis. If the Company elects to terminate the Novartis Agreement, Novartis will, subject to specified limitations, be required to pay to the Company certain payments based on achievement, with respect to such product, of the milestones that would have otherwise applied to licensed products under the Novartis Agreement. Activities under the Novartis Agreement were evaluated under ASC 605-25, Revenue Recognition—Multiple Element Arrangements (“ASC 605-25”) (as amended by ASU 2009-13, Revenue Recognition (“ASU 2009-13”)) to determine if they represented a multiple element revenue arrangement. The Novartis Agreement includes the following deliverables: (1) an exclusive license to commercialize Fovista outside the United States (the “License Deliverable”); (2) the performance obligation to conduct research and development activities related to the Phase 3 Fovista clinical trials and certain Phase 2 trials for Fovista (the “R&D Activity Deliverable”); (3) the performance obligation to supply API to Novartis for development and manufacturing purposes (the “Manufacturing Deliverable”) and (4) the Company’s obligation to participate on the joint operating committee established under the terms of the Novartis Agreement and related subcommittees (the “Joint Operating Committee Deliverable”). Novartis has the right, subject to certain approval rights of the Company, to sublicense the exclusive royalty-bearing license to commercialize Fovista in the Novartis Territory. The Company’s obligation to provide access to clinical and regulatory information as part of the License Deliverable includes the obligation to provide access to all clinical data, regulatory filings, safety data and manufacturing data to Novartis which is necessary for the commercialization of Fovista in the Novartis Territory. The R&D Activity Deliverable includes the right and responsibility for the Company to conduct the Phase 3 Fovista clinical program and other studies of Fovista in the Novartis Territory which are necessary or desirable for regulatory approval or commercialization of Fovista. The Manufacturing Deliverable includes the obligation for the Company to supply API to Novartis for clinical purposes, for which Novartis has agreed to pay the Company’s manufacturing costs, and for commercial purposes, for which Novartis has agreed to pay the Company’s manufacturing costs plus a specified margin. The Joint Operating Committee Deliverable includes the obligation to participate in the Joint Operating Committee and related subcommittees at least through the first anniversary of regulatory approval in the European Union. All of these deliverables were deemed to have stand-alone value and to meet the criteria to be accounted for as separate units of accounting under ASC 605-25. Factors considered in this determination included, among other things, the subject of the licenses and the research and development and commercial capabilities of Novartis. Accordingly, each unit will be accounted for separately. Options are considered substantive if, at the inception of the arrangement, the Company is at risk as to whether the collaboration partner will choose to exercise the option. Factors that the Company considers in evaluating whether an option is substantive include the overall objective of the arrangement, the benefit the collaborator might obtain from the arrangement without exercising the option, the cost to exercise the option and the likelihood that the option will be exercised. For arrangements under which an option is considered substantive, assuming the option is not priced at a significant and incremental discount, the Company does not consider the item underlying the option to be a deliverable at the inception of the arrangement and the associated option fees are not included in allocable arrangement consideration. Conversely, for arrangements under which an option is not considered substantive or if an option is priced at a significant and incremental discount, the Company would consider the item underlying the option to be a deliverable at the inception of the arrangement and a corresponding amount would be included in allocable arrangement consideration. All of the options included in the Novartis Agreement have been determined to be substantive, and none of the options are priced at a significant and incremental discount. The Novartis Agreement provides that, if the Company elects to terminate the Novartis Agreement because specified governmental actions prevent the parties from materially progressing the development or commercialization of licensed products as described above, the Company will be required to pay a substantial termination fee. The Company has concluded that this termination provision constitutes a contingent event that was unknown at the inception of the agreement. As such, the Company has recorded the $200.0 million upfront payment in deferred revenue, long-term until such time that the contingency related to this termination provision is resolved. The Company believes the enrollment-based milestones and certain reimbursement milestones that may be achieved under the Novartis Agreement do not meet the recognition criteria within the definition of a milestone included in ASU 2010-17, Revenue Recognition—Milestone Method , and therefore, payments received for the achievement of the enrollment milestones in excess of the termination fee will be included in the allocable arrangement consideration and allocated to the deliverables based upon BESP using the relative selling price method. The Company believes the marketing approval milestones that may be achieved under the Novartis Agreement are consistent with the definition of a milestone included in ASU 2010-17, Revenue Recognition—Milestone Method , and, accordingly, the Company will recognize payments related to the achievement of such milestones, if any, when the applicable milestone is achieved. Factors considered in this determination included scientific and regulatory risks that must be overcome to achieve each milestone, the level of effort and investment required to achieve each milestone, and the monetary value attributed to each milestone. In May 2014, the Company received an upfront payment of $200.0 million in connection with its entry into the Novartis Agreement, which has not been recorded as revenue due to certain contingencies associated with the payment. In each of September 2014 and March 2015, the Company achieved a $50.0 million enrollment-based milestone, and in June 2016, the Company achieved a $30.0 million enrollment-based milestone, for an aggregate total of $130.0 million , under the Novartis Agreement. The Company uses the relative selling price method to allocate arrangement consideration to the Company’s performance obligations under the Novartis Agreement. Below is a summary of the components of the Company’s collaboration revenue for the three and nine months ended September 30, 2016 and September 30, 2015 : Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 License revenue $ — $ — $ 22,937 $ 38,083 Research and development activity revenue 1,664 1,594 8,089 6,768 API transfer revenue — 1,851 14,545 1,851 Joint operating committee revenue 4 3 16 21 Total collaboration revenue $ 1,668 $ 3,448 $ 45,587 $ 46,723 As of September 30, 2016 , the Company had recorded total deferred revenue of approximately $211.8 million , $200.0 million of which relates to the upfront payment, with the remaining $11.8 million primarily attributable to the Company’s on-going performance obligations under the R&D Activity Deliverable. |
Financing Agreement with Novo A
Financing Agreement with Novo A/S | 9 Months Ended |
Sep. 30, 2016 | |
Related Party Transactions [Abstract] | |
Financing Agreement with Novo A/S | 6. Financing Agreement with Novo A/S In May 2013, the Company entered into a Purchase and Sale Agreement with Novo A/S, which is referred to as the Novo Agreement, pursuant to which the Company had the ability to obtain financing in three tranches in an amount of up to $125.0 million in return for the sale to Novo A/S of aggregate royalties of worldwide sales of (a) Fovista, (b) Fovista-Related Products, and (c) Other Products (each as defined in the Novo Agreement), calculated as mid-single digit percentages of net sales. The Novo Agreement provided for up to three separate purchases for a purchase price of $41.7 million each, at a first, second and third closing, for an aggregate purchase price of $125.0 million . In each purchase, Novo A/S would acquire rights to a low single digit percentage of net sales. In each of May 2013, January 2014 and November 2014, the Company received cash payments of $41.7 million , or $125.0 million in the aggregate, and Novo A/S received, in the aggregate, a right to receive royalties on net sales of Fovista at a mid-single digit percentage. The royalty payment period covered by the Novo Agreement begins on commercial launch and ends, on a product-by-product and country-by-country basis, on the latest to occur of (i) the 12th anniversary of the commercial launch, (ii) the expiration of certain patent rights and (iii) the expiration of the regulatory exclusivity for each product in each country. Under the terms of the Novo Agreement, the Company is not required to reimburse or otherwise compensate Novo A/S through any means other than the agreed royalty entitlement. In addition, the Company does not, under the terms of the Novo Agreement, have the right or obligation to prepay Novo A/S in connection with a change of control of the Company or otherwise. The $125.0 million in aggregate proceeds from the three financing tranches under the Novo Agreement represents the full funding available under the Novo Agreement, and has been recorded as a liability on the Company’s Balance Sheet as of September 30, 2016 , in accordance with ASC 730, Research and Development . Because there is a significant related party relationship between the Company and Novo A/S, the Company is treating its obligation to make royalty payments under the Novo Agreement as an implicit obligation to repay the funds advanced by Novo A/S. As the Company makes royalty payments in accordance with the Novo Agreement, it will reduce the liability balance. At the time that such royalty payments become probable and estimable, and if such amounts exceed the liability balance, the Company will impute interest accordingly on a prospective basis based on such estimates, which would result in a corresponding increase in the liability balance. The Novo Agreement requires the establishment of a Joint Oversight Committee in the event that Novo A/S does not continue to have a representative on the Company’s board of directors. The Joint Oversight Committee would have responsibilities that include “discussion and review” of all matters related to Fovista research, development, regulatory approval and commercialization, but there is no provision either implicit or explicit that gives the Joint Oversight Committee or its members decision-making authority. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 7. Income Taxes The Company utilizes the liability method of accounting for deferred income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. A valuation allowance is established against deferred tax assets when, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible, and is impacted by the Company’s ability to carry back losses to 2014 , the only year in which the Company had taxable income. The Company is currently projecting tax losses in 2016 . The Company expects to realize its net deferred tax assets recorded as of December 31, 2015 in 2016 due to the Company’s ability to carry back its 2015 federal tax losses to 2014 . As such, the Company reclassified these amounts to income tax receivable on the Company’s Balance Sheet as of September 30, 2016 . The Company expects to carry forward its 2015 state tax losses due to various state restrictions on the use of carryback claims. The state NOLs are expected to begin to expire in 2027. Due to the Company’s history of losses and lack of other positive evidence to support taxable income after the 2014 tax year, the Company has recorded a valuation allowance against those remaining deferred tax assets that are not expected to be realized. Deferred tax assets relating to employee share-based compensation deductions were reduced to reflect exercises of non-qualified stock option grants and vesting of RSUs. Although certain of these deductions will be reported on the corporate tax returns and increase the Company’s NOLs, these related tax benefits are not recognized for financial reporting purposes. The Company recorded a provision for income taxes of $0.1 million for the three months ended September 30, 2016 , and a benefit from income taxes of $7.5 million for the three months ended September 30, 2015 . For the nine months ended September 30, 2016 and 2015 , the Company recorded a benefit from income taxes of $0.2 million and $11.6 million , respectively. The benefit from income taxes recorded in each period of 2016 and 2015 was based upon the Company’s estimated federal and state income tax liability for those respective years. For the three months ended September 30, 2016 , the Company recorded a discrete income tax provision of $0.1 million . For the nine months ended September 30, 2016 , the Company recorded a discrete income tax benefit of $0.2 million related to the reduction in its valuation allowances to reflect the income tax associated with unrealized gains on available for sale securities recorded in other comprehensive income (loss). A corresponding income tax provision was also recorded in other comprehensive income (loss). Pursuant to ASC 740, Income Taxes , the Company routinely evaluates the likelihood of success if challenged on income tax positions claimed on its income tax returns. During the three months ended September 30, 2016, the Company reduced certain deferred tax assets by $3.8 million and reduced the corresponding valuation allowance by an equivalent amount. These items have not been recognized in the financial statements and if disallowed by the tax authorities, would not result in an adjustment to the Company’s effective tax rate, its balance sheet or its cash flow statements for the current year. The Company will continue to evaluate its ability to realize its deferred tax assets on a periodic basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits and the regulatory approval of products currently under development. Any additional changes to the valuation allowance recorded on deferred tax assets in the future would impact the Company’s income taxes. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 8. Fair Value Measurements ASC 820, Fair Value Measurements and Disclosures (“ASC 820”), defines fair value as the price that would be received to sell an asset, or paid to transfer a liability, in the principal or most advantageous market in an orderly transaction between market participants on the measurement date. The fair value standard also establishes a three-level hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company reviews investments on a periodic basis for other than temporary impairments. This review is subjective as it requires management to evaluate whether an event or change in circumstances has occurred in the period that may have a significant adverse effect on the fair value of the investment. The Company uses the market approach to measure fair value for its financial assets. The market approach uses prices and other relevant information generated by market transactions involving identical or comparable assets. The Company classifies its corporate debt securities within the fair value hierarchy as Level 2 assets, as it primarily utilizes quoted market prices or rates for similar instruments to value these securities. The valuation hierarchy is based upon the transparency of inputs to the valuation of an asset or liability on the measurement date. The three levels are defined as follows: • Level 1—inputs to the valuation methodology are quoted prices (unadjusted) for an identical asset or liability in an active market. The Company’s Level 1 assets consist of investments in money market funds and U.S. Treasury securities. • Level 2—inputs to the valuation methodology include quoted prices for a similar asset or liability in an active market or model-derived valuations in which all significant inputs are observable for substantially the full term of the asset or liability. The Company’s Level 2 assets consist of investments in investment-grade corporate debt securities. • Level 3—inputs to the valuation methodology are unobservable and significant to the fair value measurement of the asset or liability. The Company does not hold any assets that are measured using Level 3 inputs. The following table presents, for each of the fair value hierarchy levels required under ASC 820, the Company’s assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2016 : Fair Value Measurement Using Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets Investments in money market funds* $ 157,114 $ — $ — Investments in U.S. Treasury securities $ 120,320 $ — $ — Investments in Corporate debt securities $ — $ 38,225 $ — The following table presents, for each of the fair value hierarchy levels required under ASC 820, the Company’s assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2015 : Fair Value Measurement Using Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets Investments in money market funds* $ 196,188 $ — $ — Investments in U.S. Treasury securities* $ 150,387 $ — $ — Investments in Corporate debt securities $ — $ 39,833 $ — * Investments in money market funds, U.S. Treasury securities and corporate debt securities with maturities less than 90 days are reflected in cash and cash equivalents in the accompanying Balance Sheets. No transfer of assets between Level 1 and Level 2 of the fair value hierarchy occurred during the three and nine months ended September 30, 2016 . |
Stock Option and Compensation P
Stock Option and Compensation Plans | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Option and Compensation Plans | 9. Stock Option and Compensation Plans The Company adopted its 2007 Stock Incentive Plan (the “2007 Plan”) for employees, non-employee directors and consultants for the purpose of advancing the interests of the Company’s stockholders by enhancing its ability to attract, retain and motivate persons who are expected to make important contributions to the Company. The 2007 Plan provided for the granting of stock option awards, RSUs, and other stock-based and cash-based awards. Following the effectiveness of the 2013 Stock Incentive Plan described below in connection with the closing of the Company’s initial public offering, the Company is no longer granting additional awards under the 2007 Plan. In August 2013, the Company’s board of directors adopted and the Company’s stockholders approved the 2013 stock incentive plan (the “2013 Plan”), which became effective immediately prior to the closing of the Company’s initial public offering. In June 2015, the Company’s board of directors adopted a first amendment to the 2013 Plan. The 2013 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, RSUs, restricted stock awards and other stock-based awards. Upon the effectiveness of the 2013 Plan, the number of shares of the Company’s common stock that were reserved for issuance under the 2013 Plan was the sum of (1) such number of shares (up to approximately 3,359,641 shares) as is equal to the sum of 739,317 shares (the number of shares of the common stock then available for issuance under the 2007 Plan), and such number of shares of the Company’s common stock that are subject to outstanding awards under the 2007 Plan that expire, terminate or are otherwise surrendered, canceled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right plus (2) an annual increase, to be added the first business day of each fiscal year, beginning with the fiscal year ending December 31, 2014 and continuing until, and including, the fiscal year ending December 31, 2023, equal to the lowest of 2,542,372 shares of the Company’s common stock, 4% of the number of shares of the Company’s common stock outstanding on the first day of the fiscal year and an amount determined by its board of directors. The Company’s employees, officers, directors, consultants and advisors are eligible to receive awards under the 2013 Plan. However, incentive stock options may only be granted to employees of the Company. In connection with the evergreen provisions of the 2013 Plan, the number of shares available for issuance under the 2013 Plan was increased by approximately 1,257,000 shares, effective as of January 1, 2014, by approximately 1,360,000 shares, effective as of January 1, 2015, and by approximately 1,408,000 shares, effective as of January 1, 2016. As of September 30, 2016 , the Company had approximately 1,048,000 shares available for grant under the 2013 Plan. In April 2016, the board of directors adopted the ESPP pursuant to which the Company may sell up to an aggregate of 1,000,000 shares of common stock. The ESPP was approved by the Company’s stockholders in June 2016. The ESPP allows eligible employees to purchase common stock at a price per share equal to 85% of the lower of the fair market value of the common stock at the beginning or end of each six month offering period during the term of the ESPP. The first offering period began in September 2016. A summary of the stock option activity, weighted average exercise prices, options outstanding and exercisable as of September 30, 2016 is as follows: Common Stock Options Weighted Average Exercise Price Outstanding, December 31, 2015 3,009 $ 30.43 Granted 952 $ 60.81 Exercised (350 ) $ 16.89 Expired or forfeited (188 ) $ 48.59 Outstanding, September 30, 2016 3,423 $ 39.26 Options exercisable at September 30, 2016 1,399 Weighted average grant date fair value (per share) of options granted during the period $ 38.49 As of September 30, 2016 , there were approximately 3,198,000 options outstanding, net of estimated forfeitures, that had vested or are expected to vest. The weighted-average exercise price of these options was $39.42 per option; the weighted-average remaining contractual life of these options was 7.8 years ; and the aggregate intrinsic value of these options was approximately $35.2 million . A summary of the stock options outstanding and exercisable as of September 30, 2016 is as follows: As of September 30, 2016 Options Outstanding Options Exercisable Range of Exercise Prices Total Options Outstanding Weighted Average Remaining Life (Years) Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $0.12-$10.03 257 5.6 $ 6.77 158 $ 4.74 $10.04-$20.00 274 6.7 $ 13.44 151 $ 13.48 $20.01-$30.00 154 7.1 $ 25.56 102 $ 25.51 $30.01-$40.00 1,093 6.9 $ 32.67 699 $ 33.05 $40.01-$55.00 1,115 8.8 $ 46.24 267 $ 45.65 $55.01-$73.22 530 9.3 $ 71.26 22 $ 70.28 3,423 7.8 $ 39.26 1,399 $ 30.18 Aggregate Intrinsic Value $ 38,226 $ 23,077 Cash proceeds from, and the aggregate intrinsic value of, stock options exercised during the three and nine months ended September 30, 2016 and 2015 , respectively, were as follows: Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 Cash proceeds from options exercised $ 1,591 $ 1,813 $ 5,398 $ 6,024 Aggregate intrinsic value of options exercised $ 5,185 $ 10,092 $ 12,607 $ 39,033 In connection with stock option awards granted to employees, the Company recognized approximately $5.6 million and $3.4 million in share-based compensation expense during the three months ended September 30, 2016 and 2015 , respectively, net of expected forfeitures. In connection with stock option awards granted to employees, the Company recognized approximately $17.3 million and $11.4 million in share-based compensation expense during the nine months ended September 30, 2016 and 2015 , respectively, net of expected forfeitures. As of September 30, 2016 , there were approximately $48.3 million of unrecognized compensation costs, net of estimated forfeitures, related to stock option awards granted to employees, which are expected to be recognized over a remaining weighted average period of 2.7 years . In connection with stock option awards granted to consultants, the Company recognized approximately $0.6 million and $1.8 million in share-based compensation expense during the three months ended September 30, 2016 and 2015 , respectively, net of expected forfeitures. In connection with stock option awards granted to consultants, the Company recognized approximately $1.5 million and $3.4 million in share-based compensation expense during the nine months ended September 30, 2016 and 2015 , respectively, net of expected forfeitures. As of September 30, 2016 , there were approximately $1.4 million of unrecognized compensation costs, net of estimated forfeitures, related to stock option awards granted to consultants, which are expected to be recognized over a remaining weighted average period of 1.4 years . The following table presents a summary of the Company’s outstanding RSU awards granted as of September 30, 2016 : Restricted Stock Units Weighted Average Grant-Date Fair Value Outstanding, December 31, 2015 288 $ 44.54 Awarded 574 $ 58.43 Vested (103 ) $ 44.07 Forfeited (38 ) $ 50.84 Outstanding, September 30, 2016 721 $ 55.32 As of September 30, 2016 , there were approximately 513,000 RSUs outstanding, net of estimated forfeitures, that are expected to vest. The weighted-average fair value of these RSUs was $54.45 and the aggregate intrinsic value of these RSUs was approximately $23.7 million . In connection with RSUs granted to employees, the Company recognized approximately $2.0 million and $1.8 million in share-based compensation expense during the three months ended September 30, 2016 and 2015 , respectively, net of expected forfeitures. In connection with RSUs granted to employees, the Company recognized approximately $6.1 million and $3.7 million in share-based compensation expense during the nine months ended September 30, 2016 and 2015 , respectively, net of expected forfeitures. As of September 30, 2016 , there were approximately $31.7 million of unrecognized compensation costs, net of estimated forfeitures, related to RSUs granted to employees, which are expected to be recognized over a remaining weighted average period of 2.5 years . In connection with the ESPP made available to employees, the Company recognized a de minimis amount of share-based compensation expense during the three and nine months ended September 30, 2016 . As of September 30, 2016 , there were approximately $0.3 million of unrecognized compensation costs, net of estimated forfeitures, related to the ESPP, which are expected to be recognized over 0.5 years . |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 10. Property and Equipment Property and equipment as of September 30, 2016 and December 31, 2015 were as follows: Useful Life (Years) September 30, 2016 December 31, 2015 Manufacturing and clinical equipment 7 - 10 $ 617 $ 617 Computer, software and other office equipment 5 1,621 944 Furniture and fixtures 7 774 738 Leasehold improvements 3 - 5 1,600 1,551 Construction-in-progress — 515 4,612 4,365 Accumulated depreciation (1,438 ) (899 ) Property and equipment, net $ 3,174 $ 3,466 For the three and nine months ended September 30, 2016 , depreciation expense was $186 thousand and $539 thousand , respectively. For the three and nine months ended September 30, 2015 , depreciation expense was $77 thousand and $535 thousand , respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 11. Commitments and Contingencies Under various agreements, the Company may be required to pay royalties and make milestone payments. These agreements include the following: • Under the Company’s divestiture agreement with OSI (Eyetech), Inc., which agreement is now held by OSI Pharmaceuticals, LLC., or OSI Pharmaceuticals, a subsidiary of Astellas US, LLC, for rights to particular anti-PDGF aptamers, including Fovista, the Company is obligated to pay to OSI Pharmaceuticals future one-time payments of $12.0 million in the aggregate upon marketing approval in the United States and the European Union of a covered anti-PDGF product. The Company is also obligated to pay to OSI Pharmaceuticals a royalty at a low single-digit percentage of net sales of any covered anti-PDGF product the Company successfully commercializes. • Under a license agreement with Archemix Corp., or Archemix, with respect to pharmaceutical products comprised of or derived from any anti-PDGF aptamer, the Company is obligated to make future payments to Archemix of up to an aggregate of $14.0 million if the Company achieves specified clinical and regulatory milestones with respect to Fovista, up to an aggregate of $3.0 million if the Company achieves specified commercial milestones with respect to Fovista and, for each other anti-PDGF aptamer product that it may develop under the agreement, up to an aggregate of approximately $18.8 million if the Company achieves specified clinical and regulatory milestones and up to an aggregate of $3.0 million if the Company achieves specified commercial milestones. No royalties are payable to Archemix under this license agreement. • Under a license agreement with Archemix with respect to pharmaceutical products comprised of or derived from anti-C5 aptamers, for each anti-C5 aptamer product that the Company may develop under the agreement, including Zimura, the Company is obligated to make future payments to Archemix of up to an aggregate of $57.5 million if the Company achieves specified development, clinical and regulatory milestones and up to an aggregate of $22.5 million if the Company achieves specified commercial milestones. The Company is also obligated to pay Archemix a double-digit percentage of specified non-royalty payments the Company may receive from any sublicensee of the Company’s rights under this license agreement. No royalties are payable to Archemix under this license agreement. • Under a license, manufacturing and supply agreement with Nektar Therapeutics, or Nektar, for specified pegylation reagents used to manufacture Fovista, the Company is obligated to make future payments to Nektar of up to an aggregate of $6.5 million if the Company achieves specified clinical and regulatory milestones, and an additional payment of $3.0 million if the Company achieves a specified commercial milestone with respect to Fovista. The Company is obligated to pay Nektar tiered royalties at low to mid-single-digit percentages of net sales of any licensed product the Company successfully commercializes, with the royalty percentage determined by the Company’s level of licensed product sales, the extent of patent coverage for the licensed product and whether the Company has granted a third-party commercialization rights to the licensed product. In June 2014, the Company paid Nektar $19.8 million in connection with its entry into the Novartis Agreement. • Under an option agreement with AVEO Pharmaceuticals relating to tivozanib, the Company will be obligated to make milestone payments of $2.0 million upon the submission of an Investigational New Drug Application to the FDA and $6.0 million upon the earlier of demonstration of proof of concept in humans and a specified date in January 2017, subject to any exercise by the Company of its right to terminate the option agreement. • Under the Company’s Fill/Finish Capacity Reservation Agreement with Althea (described in Note 12 below), the Company will be obligated to make future payments of up to $14.4 million , payable in installments upon expiration of the Company's termination option under the Fill/Finish Capacity Reservation Agreement and upon Althea’s achievement of certain validation and production milestones with respect to its new high-speed fill/finish line. The Company also has letter agreements with certain employees that require the funding of a specific level of payments, if certain events, such as a termination of employment in connection with a change in control or termination of employment by the employee for good reason or by the Company without cause, occur. For a description of these obligations, see the Company’s definitive proxy statement on Schedule 14A for the Company’s 2016 annual meeting of stockholders, as filed with the SEC on April 29, 2016. In addition, in the course of normal business operations, the Company has agreements with contract service providers to assist in the performance of the Company’s research and development and manufacturing activities. Expenditures to CROs and CMOs represent significant costs in clinical development. Subject to required notice periods and the Company’s obligations under binding purchase orders, the Company can elect to discontinue the work under these agreements at any time. |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Event | 12. Subsequent Event Fill/Finish Agreements with Ajinomoto Althea, Inc. In October 2016, the Company and Ajinomoto Althea, Inc., or Althea, entered into a Clinical and Commercial Services Agreement (the “Fill/Finish Services Agreement”) and a Capacity Reservation Agreement (the “Fill/Finish Capacity Reservation Agreement”). Under the Fill/Finish Services Agreement, Althea has agreed to provide clinical and commercial fill/finish services for Fovista and Zimura, as well as any future product candidates that the Company and Althea may mutually agree. Under the Fill/Finish Capacity Reservation Agreement, Althea commits to make available to the Company certain minimum guaranteed capacity on a new high-speed fill/finish line to be purchased and installed by Althea in a new manufacturing facility in San Diego, California, in exchange for the Company making capacity reservation fee payments in an aggregate amount of up to $16.0 million . To date, the Company has made non-refundable payments of approximately $1.6 million with respect to its $16.0 million commitment to support certain engineering activities with respect to the high-speed fill/finish line. The Company may terminate the Fill/Finish Capacity Reservation Agreement within 30 days following the date on which the Company first publicly announces the initial, top-line data from its two Phase 3 clinical trials of Fovista administered in combination with Lucentis. |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited financial information as of September 30, 2016 and for the three and nine months ended September 30, 2016 and 2015 has been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The December 31, 2015 Balance Sheet was derived from the Company’s audited financial statements. These interim financial statements should be read in conjunction with the notes to the financial statements contained in the Company’s Annual Report on Form 10-K (“Annual Report”) for 2015 , as filed with the SEC on February 26, 2016. In the opinion of management, the unaudited financial information as of September 30, 2016 and for the three and nine months ended September 30, 2016 and 2015 , reflects all adjustments, which are normal recurring adjustments, necessary to present a fair statement of financial position, results of operations and cash flows. The results of operations for the three and nine months ended September 30, 2016 and 2015 are not necessarily indicative of the operating results for the full fiscal year or any future period. |
Use of Estimates | Use of Estimates The preparation of financial statements and related disclosures in conformity with GAAP requires management to make estimates and judgments that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s Balance Sheets and the amount of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, accounting for research and development costs, revenue recognition, accounting for share-based compensation and accounting for income taxes. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of 90 days or less when purchased to be cash equivalents. The carrying amounts reported in the Balance Sheets for cash and cash equivalents are valued at cost, which approximates their fair value. |
Available for Sale Securities | Available for Sale Securities The Company considers securities with original maturities of greater than 90 days when purchased to be available for sale securities. Available for sale securities with original maturities of greater than one year are recorded as non-current assets. Available for sale securities are recorded at fair value and unrealized gains and losses are recorded within accumulated other comprehensive income (loss). The estimated fair value of the available for sale securities is determined based on quoted market prices or rates for similar instruments. In addition, the cost of debt securities in this category is adjusted for amortization of premium and accretion of discount to maturity. The Company evaluates securities with unrealized losses to determine whether such losses, if any, are other than temporary. |
Revenue Recognition | Revenue Recognition Collaboration Revenue Prior to 2014, the Company had not generated any revenue. In May 2014, the Company received an upfront payment of $200.0 million in connection with its licensing and commercialization agreement with Novartis Pharma AG, (the “Novartis Agreement”), which has not been recorded as revenue due to certain contingencies associated with the payment. In each of September 2014 and March 2015, the Company achieved a $50.0 million enrollment-based milestone, and in June 2016, the Company achieved a $30.0 million enrollment-based milestone, for an aggregate total of $130.0 million , under the Novartis Agreement. The Company uses the relative selling price method to allocate arrangement consideration to the Company’s performance obligations under the Novartis Agreement. Below is a summary of the components of the Company’s collaboration revenue for the three and nine months ended September 30, 2016 and 2015 : Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 License revenue $ — $ — $ 22,937 $ 38,083 Research and development activity revenue 1,664 1,594 8,089 6,768 API transfer revenue — 1,851 14,545 1,851 Joint operating committee revenue 4 3 16 21 Total collaboration revenue $ 1,668 $ 3,448 $ 45,587 $ 46,723 In the future, the Company may generate additional revenues from a combination of product sales and license fees, milestone payments, research and development activity-related payments, payments for manufactured material and royalties in connection with the Novartis Agreement. The terms of this agreement and other potential collaboration or commercialization agreements the Company may enter into generally contain multiple elements, or deliverables, which may include (i) licenses, or options to obtain licenses, to certain of the Company’s technology and products, (ii) research and development activities to be performed on behalf of the collaborative partner, and (iii) in certain cases, services in connection with the manufacturing of preclinical, clinical and commercial material. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; milestone payments; payments for manufactured material; and royalties on future product sales. When evaluating multiple element arrangements, the Company considers whether the deliverables under the arrangement represent separate units of accounting. This evaluation requires subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. In determining the units of accounting, management evaluates certain criteria, including whether the deliverables have standalone value, based on the relevant facts and circumstances for each arrangement. The consideration received is allocated among the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria are applied to each of the separate units. The Company determines the estimated selling price for deliverables within each agreement using vendor-specific objective evidence (“VSOE”) of selling price, if available, third-party evidence (“TPE”) of selling price if VSOE is not available, or best estimate of selling price (“BESP”) if neither VSOE nor TPE is available. Determining the best estimate of selling price for a deliverable requires significant judgment. The Company uses BESP to estimate the selling price for licenses to the Company’s proprietary technology, since the Company often does not have VSOE or TPE of selling price for these deliverables. In those circumstances where the Company utilizes BESP to determine the estimated selling price of a license to the Company’s proprietary technology, the Company considers market conditions as well as entity-specific factors, including those factors contemplated in negotiating the agreements as well as internally developed models that include assumptions related to the market opportunity, estimated development costs, probability of success and the time needed to commercialize a product candidate that is subject to the license. In validating the Company’s BESP, the Company evaluates whether changes in the key assumptions used to determine the BESP will have a significant effect on the allocation of arrangement consideration among multiple deliverables. When management believes the license to its intellectual property and products has stand-alone value, the Company generally recognizes revenue attributed to the license upon delivery. When management believes such a license does not have stand-alone value from the other deliverables to be provided in the arrangement, the Company generally recognizes revenue attributed to the license on a straight-line basis over the Company’s contractual or estimated performance period, which is typically the term of the Company’s research and development obligations. If management cannot reasonably estimate when the Company’s performance obligation ends, then revenue is deferred until management can reasonably estimate when the performance obligation ends. The periods over which revenue should be recognized are subject to estimates by management and may change over the course of the research and development agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. At the inception of arrangements that include milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance, and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. The Company evaluates factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. The Company aggregates its milestones into three categories: (i) clinical and development milestones, (ii) regulatory milestones, and (iii) commercial milestones. Clinical and development milestones are typically achieved when a product candidate advances into a defined phase of clinical research or completes such phase or when a contractually specified clinical trial enrollment target is attained. Regulatory milestones are typically achieved upon acceptance of the submission of an application for marketing approval for a product candidate or upon approval to market the product candidate by the U.S. Food and Drug Administration (the “FDA”) or other regulatory authorities. Commercial milestones are typically achieved when an approved pharmaceutical product reaches certain defined levels of net sales by the licensee, such as when a product first achieves global sales or annual sales of a specified amount. Revenues from clinical and development and regulatory milestone payments, if the milestones are deemed substantive and the milestone payments are nonrefundable, are recognized upon successful accomplishment of the milestones. With regard to the Novartis Agreement, the Company has concluded that the clinical and development milestones and certain reimbursement milestones are not substantive and that the marketing approval milestones are substantive. Milestone payments received that are not considered substantive are included in the allocable arrangement consideration and are recognized as revenue in proportion to the relative selling price allocation established at the inception of the arrangement. Revenues from commercial milestone payments are accounted for as royalties and are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. |
Concentration of Credit Risk | Concentration of Credit Risk The Company’s financial instruments that are exposed to concentration of credit risk consist primarily of cash and cash equivalents and available for sale securities. The Company maintains its cash in bank accounts, which generally exceed federally insured limits. The Company maintains its cash equivalents in investments in money market funds and, at times, in U.S. Treasury securities and investment-grade corporate debt securities with original maturities of 90 days or less. The Company’s available for sale securities are also invested in U.S. Treasury securities and investment-grade corporate debt securities. The Company believes it is not exposed to significant credit risk on its cash, cash equivalents and available for sale securities. |
Concentration of Suppliers | Concentration of Suppliers The Company currently relies exclusively upon a single third-party manufacturer to provide supplies of the active pharmaceutical ingredient, or API, for both Fovista and Zimura. The Company also engages a single third-party manufacturer to provide fill/finish services for clinical supplies of both Fovista and Zimura. In addition, the Company currently relies exclusively upon Nektar Therapeutics, or Nektar, to supply it with a proprietary polyethylene glycol, or PEG, reagent for Fovista under a manufacturing and supply agreement. PEG reagent is a chemical the Company uses to modify the chemically synthesized aptamer in Fovista. The PEG reagent made by Nektar is proprietary to Nektar. The Company obtains a different proprietary PEG reagent used to modify the chemically synthesized aptamer in Zimura from a different supplier on a purchase order basis. Furthermore, the Company and its contract manufacturers currently rely upon sole-source suppliers of certain raw materials and other specialized components of production used in the manufacture and fill/finish of each of Fovista and Zimura. If the Company’s third-party manufacturers or fill/finish service providers should become unavailable to the Company for any reason, including as a result of capacity constraints, financial difficulties or insolvency, the Company believes that there are a limited number of potential replacement manufacturers, and the Company likely would incur added costs and delays in identifying or qualifying such replacements. |
Foreign Currency Translation | Foreign Currency Translation The Company considers the U.S. dollar to be its functional currency. Expenses denominated in foreign currencies are translated at the exchange rate on the date the expense is incurred. The effect of exchange rate fluctuations on translating foreign currency assets and liabilities into U.S. dollars is included in the Statements of Operations. Foreign exchange transaction gains and losses are included in the results of operations and are not material in the Company’s financial statements. |
Financial Instruments | Financial Instruments Cash equivalents and available for sale securities are reflected in the accompanying financial statements at fair value. The carrying amount of accounts payable and accrued expenses, including accrued research and development expenses, approximates fair value due to the short-term nature of those instruments. |
Property and Equipment | Property and Equipment Property and equipment, which consists mainly of manufacturing and clinical equipment, furniture and fixtures, computers, software, and other office equipment, and leasehold improvements, are carried at cost less accumulated depreciation. Depreciation is computed over the estimated useful lives of the respective assets, generally three to ten years, using the straight-line method. |
Research and Development | Research and Development Research and development expenses primarily consist of costs associated with the manufacturing, development and clinical testing of Fovista and Zimura as well as costs associated with the preclinical development of other product candidates and formulations. Research and development expenses consist of: • external research and development expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”) and other vendors and contract manufacturing organizations (“CMOs”) for the production of drug substance and drug product; and • employee-related expenses, including salaries, benefits and share-based compensation expense. Research and development expenses also include costs of acquired product licenses and related technology rights where there is no alternative future use, costs of prototypes used in research and development, consultant fees and amounts paid to collaborative partners. All research and development expenses are charged to operations as incurred in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic, or ASC, 730, Research and Development . The Company accounts for non-refundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received, rather than when the payment is made. |
Income Taxes | Income Taxes The Company utilizes the liability method of accounting for deferred income taxes, as set forth in ASC 740, Income Taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. The Company incurred U.S. federal net operating losses (“NOLs”) in each year from its inception in 2007 through 2013 and utilized these NOLs in 2014. Additionally, the Company incurred a U.S. federal net operating loss in 2015 that has been carried back to 2014. Accordingly, all tax years since 2007 are subject to potential tax examination. In the second quarter of 2016, the Internal Revenue Service began an examination of the Company’s 2014 corporate income tax return. To date, no findings or assessments have been received by the Company. |
Share-Based Compensation | Share-Based Compensation The Company follows the provisions of ASC 718, Compensation—Stock Compensation, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and non-employee directors, including employee stock options, restricted stock units (“RSUs”) and the option granted to employees to purchase shares under the 2016 Employee Stock Purchase Plan (the “ESPP”). Share-based compensation expense is based on the grant date fair value estimated in accordance with the provisions of ASC 718 and is generally recognized as an expense over the requisite service period, net of forfeitures. For grants containing performance-based vesting provisions, expense is recognized over the estimated achievement period. Stock Options The Company estimates the fair value of stock options granted to employees and non-employee directors on the date of grant using the Black-Scholes option-pricing model. Due to the lack of trading history, the Company’s computation of stock-price volatility is based on the volatility rates of comparable publicly held companies over a period equal to the expected term of the options granted by the Company. The Company’s computation of expected term is determined using the “simplified” method, which is the midpoint between the vesting date and the end of the contractual term. The Company believes that it does not have sufficient reliable exercise data in order to justify the use of a method other than the “simplified” method of estimating the expected exercise term of employee stock option grants. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends to stockholders and has no current intentions to pay cash dividends. The risk-free interest rate is based on the zero-coupon U.S. Treasury yield at the date of grant for a term equivalent to the expected term of the option. For stock options granted as consideration for services rendered by consultants, the Company recognizes expense in accordance with the requirements of ASC 505-50, Equity Based Payments to Non-Employees . Consultant stock option grants are recorded as an expense over the vesting period of the underlying stock options. At the end of each financial reporting period prior to vesting, the value of these options, as calculated using the Black-Scholes option-pricing model, will be re-measured using the fair value of the Company’s common stock and the non-cash expense recognized during the period will be adjusted accordingly. Since the fair value of options granted to consultants is subject to change in the future, the amount of the future expense will include fair value re-measurements until the stock options are fully vested. RSUs The Company estimates the fair value of RSUs granted to employees using the closing market price of the Company’s common stock on the date of grant. ESPP In April 2016, the board of directors adopted the ESPP pursuant to which the Company may sell up to an aggregate of 1,000,000 shares of common stock. The ESPP was approved by the Company’s stockholders in June 2016. The ESPP is considered compensatory and the fair value of the discount and look back provision are estimated using the Black-Scholes option-pricing model and recognized over the six month withholding period prior to purchase. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2014-9, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-9”). ASU 2014-9 outlines a new, single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. This new revenue recognition model provides a five-step analysis in determining when and how revenue is recognized. The new model will require revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services. The FASB subsequently issued additional clarifying standards to address issues arising from implementation of the new revenue standard, including a one-year deferral of the effective date for the new revenue standard. Public companies should now apply the guidance in ASU 2014-9 to annual reporting periods beginning after December 15, 2017 and interim periods within those annual periods. Earlier application is permitted only as of annual reporting periods beginning after December 15, 2016, including interim periods within that annual period. Companies may use either a full retrospective or a modified retrospective approach to adopt ASU 2014-9. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , which defines management’s responsibility to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures if there is substantial doubt about its ability to continue as a going concern. The pronouncement is effective for annual reporting periods ending after December 15, 2016 with early adoption permitted. The adoption of this guidance is not expected to have a significant impact on the Company’s financial statements. In November 2015, the FASB issued ASU 2015-17, Income Taxes (Topic 740) : Balance Sheet Classification of Deferred Taxes , which updated and simplified the presentation of deferred income taxes. Current GAAP requires an entity to separate deferred income tax assets and liabilities into current and non-current amounts in a classified statement of financial position. The requirement results in little or no benefit to users of financial statements because the classification does not generally align with the time period in which the recognized deferred tax amounts are expected to be recovered or settled. To simplify the presentation of deferred income taxes, the amendments in this update require that deferred tax assets and liabilities be classified as noncurrent in a classified statement of financial position. The current requirement that deferred tax assets and liabilities of a tax-paying component of an entity be offset and presented as a single amount is not affected by the amendments in this update. The amendments in this update are effective for financial statements issued for annual periods beginning after December 15, 2016 and interim periods within those annual periods. Earlier application is permitted as of the beginning of an interim or annual reporting period. The Company has elected to adopt this standard retrospectively, effective December 31, 2015. In February 2016, the FASB issued ASU No. 2016-2, Leases (Topic 842) . Under the new guidance, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the commencement date: (1) A lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and (2) A right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. Under the new guidance, lessor accounting is largely unchanged. Certain targeted improvements were made to align, where necessary, lessor accounting with the lessee accounting model and Topic 606, Revenue from Contracts with Customers . The new lease guidance simplified the accounting for sale and leaseback transactions primarily because lessees must recognize lease assets and lease liabilities. Lessees will no longer be provided with a source of off-balance sheet financing. Public business entities should apply the amendments in ASU 2016-2 for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years (i.e., January 1, 2019, for a calendar year entity). Early application is permitted for all public business entities and all nonpublic business entities upon issuance. Lessees (for capital and operating leases) and lessors (for sales-type, direct financing, and operating leases) must apply a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The modified retrospective approach would not require any transition accounting for leases that expired before the earliest comparative period presented. Lessees and lessors may not apply a full retrospective transition approach. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In March 2016, the FASB issued ASU 2016-9, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting . The amendments are intended to improve the accounting for employee share-based payments and affect all organizations that issue share-based payment awards to their employees. Several aspects of the accounting for share-based payment award transactions are simplified, including: ( a ) income tax consequences; ( b ) classification of awards as either equity or liabilities; and ( c ) classification on the statement of cash flows. For public companies, the amendments are effective for annual periods beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted in any interim or annual period. The Company is currently assessing the impact that adopting this new accounting guidance will have on its financial statements and footnote disclosures. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments , which clarifies the presentation of certain specific cash flow issues in the Statement of cash flows. For public companies, the amendments are effective for annual reporting periods beginning after December 15, 2017, and interim periods within those annual periods and early adoption is permitted. This new guidance is not expected to have a material impact on the Company’s Consolidated Financial Statements. |
Summary of Significant Accoun20
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of the components of collaboration revenue | Below is a summary of the components of the Company’s collaboration revenue for the three and nine months ended September 30, 2016 and 2015 : Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 License revenue $ — $ — $ 22,937 $ 38,083 Research and development activity revenue 1,664 1,594 8,089 6,768 API transfer revenue — 1,851 14,545 1,851 Joint operating committee revenue 4 3 16 21 Total collaboration revenue $ 1,668 $ 3,448 $ 45,587 $ 46,723 |
Schedule of share-based compensation expense | Share-based compensation expense includes expenses related to stock options and RSUs granted to employees, non-employee directors and consultants, as well as the option granted to employees to purchase shares under the ESPP, all of which have been reported in the Company’s Statements of Operations as follows: Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 Research and development $ 5,664 $ 5,116 $ 16,732 $ 12,535 General and administrative 2,584 1,925 8,157 5,939 Total $ 8,248 $ 7,041 $ 24,889 $ 18,474 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of computation of basic and diluted net income (loss) per common share | The following table sets forth the computation of basic and diluted net income (loss) per common share for the periods indicated: Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 Basic and diluted net loss per common share calculation: Net loss $ (60,891 ) $ (39,573 ) $ (127,137 ) $ (70,068 ) Weighted average common shares outstanding - basic and diluted 35,594 34,782 35,415 34,432 Net loss per share of common stock - basic and diluted $ (1.71 ) $ (1.14 ) $ (3.59 ) $ (2.03 ) |
Schedule of potentially dilutive securities that have been excluded from the computations of diluted weighted average common shares outstanding | The following potentially dilutive securities have been excluded from the computations of diluted weighted average common shares outstanding for the periods presented, as they would be anti-dilutive: Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 Stock options outstanding 3,423 3,224 3,423 3,224 Restricted stock units 721 285 721 285 Total 4,144 3,509 4,144 3,509 |
Cash, Cash Equivalents and Av22
Cash, Cash Equivalents and Available for Sale Securities (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | |
Summary of available for sale securities, including carrying value and estimated fair values | Available for sale securities, including carrying value and estimated fair values, are summarized as follows: As of September 30, 2016 Cost Unrealized Gains Unrealized Losses Fair Value U.S. Treasury securities $ 120,280 $ 47 $ (7 ) $ 120,320 Corporate debt securities 35,233 10 (11 ) 35,232 Total $ 155,513 $ 57 $ (18 ) $ 155,552 As of December 31, 2015 Cost Unrealized Gains Unrealized Losses Fair Value U.S. Treasury securities $ 130,507 $ — $ (311 ) $ 130,196 Corporate debt securities 39,995 — (162 ) 39,833 Total $ 170,502 $ — $ (473 ) $ 170,029 |
Schedule of changes in accumulated other comprehensive income (loss) associated with the unrealized gain (loss) on available for sale securities | The changes in accumulated other comprehensive income (loss) associated with the unrealized gain (loss) on available for sale securities during the three and nine months ended September 30, 2016 and September 30, 2015 were as follows: Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 Beginning balance $ (118 ) $ 24 $ (473 ) $ (65 ) Current period changes in fair value before reclassifications, net of tax (41 ) 85 314 174 Amounts reclassified from accumulated other comprehensive income (loss), net of tax — (30 ) — (30 ) Total other comprehensive income (loss) (41 ) 55 314 144 Ending balance $ (159 ) $ 79 $ (159 ) $ 79 |
Licensing and Commercializati23
Licensing and Commercialization Agreement with Novartis Pharma AG (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of the components of the Company's collaboration revenue | Below is a summary of the components of the Company’s collaboration revenue for the three and nine months ended September 30, 2016 and September 30, 2015 : Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 License revenue $ — $ — $ 22,937 $ 38,083 Research and development activity revenue 1,664 1,594 8,089 6,768 API transfer revenue — 1,851 14,545 1,851 Joint operating committee revenue 4 3 16 21 Total collaboration revenue $ 1,668 $ 3,448 $ 45,587 $ 46,723 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Schedule of assets and liabilities that are measured at fair value on a recurring basis | The following table presents, for each of the fair value hierarchy levels required under ASC 820, the Company’s assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2016 : Fair Value Measurement Using Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets Investments in money market funds* $ 157,114 $ — $ — Investments in U.S. Treasury securities $ 120,320 $ — $ — Investments in Corporate debt securities $ — $ 38,225 $ — The following table presents, for each of the fair value hierarchy levels required under ASC 820, the Company’s assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2015 : Fair Value Measurement Using Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Assets Investments in money market funds* $ 196,188 $ — $ — Investments in U.S. Treasury securities* $ 150,387 $ — $ — Investments in Corporate debt securities $ — $ 39,833 $ — * Investments in money market funds, U.S. Treasury securities and corporate debt securities with maturities less than 90 days are reflected in cash and cash equivalents in the accompanying Balance Sheets. |
Stock Option and Compensation25
Stock Option and Compensation Plans (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of the stock option activity including weighted average exercise prices, options outstanding and exercisable | A summary of the stock option activity, weighted average exercise prices, options outstanding and exercisable as of September 30, 2016 is as follows: Common Stock Options Weighted Average Exercise Price Outstanding, December 31, 2015 3,009 $ 30.43 Granted 952 $ 60.81 Exercised (350 ) $ 16.89 Expired or forfeited (188 ) $ 48.59 Outstanding, September 30, 2016 3,423 $ 39.26 Options exercisable at September 30, 2016 1,399 Weighted average grant date fair value (per share) of options granted during the period $ 38.49 |
Summary of the stock options outstanding and exercisable by range of exercise prices | A summary of the stock options outstanding and exercisable as of September 30, 2016 is as follows: As of September 30, 2016 Options Outstanding Options Exercisable Range of Exercise Prices Total Options Outstanding Weighted Average Remaining Life (Years) Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price $0.12-$10.03 257 5.6 $ 6.77 158 $ 4.74 $10.04-$20.00 274 6.7 $ 13.44 151 $ 13.48 $20.01-$30.00 154 7.1 $ 25.56 102 $ 25.51 $30.01-$40.00 1,093 6.9 $ 32.67 699 $ 33.05 $40.01-$55.00 1,115 8.8 $ 46.24 267 $ 45.65 $55.01-$73.22 530 9.3 $ 71.26 22 $ 70.28 3,423 7.8 $ 39.26 1,399 $ 30.18 Aggregate Intrinsic Value $ 38,226 $ 23,077 |
Schedule of cash proceeds from, and the aggregate intrinsic value of, stock options exercised | Cash proceeds from, and the aggregate intrinsic value of, stock options exercised during the three and nine months ended September 30, 2016 and 2015 , respectively, were as follows: Three months ended September 30, Nine months ended September 30, 2016 2015 2016 2015 Cash proceeds from options exercised $ 1,591 $ 1,813 $ 5,398 $ 6,024 Aggregate intrinsic value of options exercised $ 5,185 $ 10,092 $ 12,607 $ 39,033 |
Summary of outstanding RSU awards | The following table presents a summary of the Company’s outstanding RSU awards granted as of September 30, 2016 : Restricted Stock Units Weighted Average Grant-Date Fair Value Outstanding, December 31, 2015 288 $ 44.54 Awarded 574 $ 58.43 Vested (103 ) $ 44.07 Forfeited (38 ) $ 50.84 Outstanding, September 30, 2016 721 $ 55.32 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | Property and equipment as of September 30, 2016 and December 31, 2015 were as follows: Useful Life (Years) September 30, 2016 December 31, 2015 Manufacturing and clinical equipment 7 - 10 $ 617 $ 617 Computer, software and other office equipment 5 1,621 944 Furniture and fixtures 7 774 738 Leasehold improvements 3 - 5 1,600 1,551 Construction-in-progress — 515 4,612 4,365 Accumulated depreciation (1,438 ) (899 ) Property and equipment, net $ 3,174 $ 3,466 |
Business (Details)
Business (Details) | Sep. 30, 2016trial |
Phase 1 Clinical Trial | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Number of trials completed | 1 |
Phase 2b Clinical Trial | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Number of trials completed | 1 |
Patient enrollment for Phase 3 Clinical Trials | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Number of trials completed | 2 |
Patient enrollment for Phase 2a Clinical Trial | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Number of trials completed | 2 |
Summary of Significant Accoun28
Summary of Significant Accounting Policies - Collaboration Revenue (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 22 Months Ended | |||||
Jun. 30, 2016USD ($) | Mar. 31, 2015USD ($) | Sep. 30, 2014USD ($) | May 31, 2014USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2016USD ($)category | Sep. 30, 2015USD ($) | Jun. 30, 2016USD ($) | |
Components of collaboration revenue | |||||||||
Total collaboration revenue | $ 1,668 | $ 3,448 | $ 45,587 | $ 46,723 | |||||
Number of categories for milestones | category | 3 | ||||||||
License revenue | |||||||||
Components of collaboration revenue | |||||||||
Total collaboration revenue | 0 | 0 | $ 22,937 | 38,083 | |||||
Research and development activity revenue | |||||||||
Components of collaboration revenue | |||||||||
Total collaboration revenue | 1,664 | 1,594 | 8,089 | 6,768 | |||||
API transfer revenue | |||||||||
Components of collaboration revenue | |||||||||
Total collaboration revenue | 0 | 1,851 | 14,545 | 1,851 | |||||
Joint operating committee revenue | |||||||||
Components of collaboration revenue | |||||||||
Total collaboration revenue | $ 4 | $ 3 | $ 16 | $ 21 | |||||
Novartis Pharma AG | Licensing and Commercialization Agreement | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Upfront fees received | $ 200,000 | ||||||||
Novartis Pharma AG | Licensing and Commercialization Agreement | Achievement of specified patient enrollment milestones | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Patient enrollment-based milestone revenue achieved | $ 30,000 | $ 50,000 | $ 50,000 | 30,000 | $ 130,000 | ||||
Milestone payment received | $ 130,000 | $ 130,000 |
Summary of Significant Accoun29
Summary of Significant Accounting Policies - Property and Equipment (Details) | 9 Months Ended |
Sep. 30, 2016 | |
Minimum | |
Property and equipment | |
Estimated useful lives | 3 years |
Maximum | |
Property and equipment | |
Estimated useful lives | 10 years |
Summary of Significant Accoun30
Summary of Significant Accounting Policies - Share-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Apr. 30, 2016 | |
Accounting Policies [Abstract] | |||||
Dividend yield (as a percent) | 0.00% | ||||
Share-Based Compensation | |||||
Share-based compensation expense | $ 8,248 | $ 7,041 | $ 24,889 | $ 18,474 | |
Research and development | |||||
Share-Based Compensation | |||||
Share-based compensation expense | 5,664 | 5,116 | 16,732 | 12,535 | |
General and administrative | |||||
Share-Based Compensation | |||||
Share-based compensation expense | $ 2,584 | $ 1,925 | $ 8,157 | $ 5,939 | |
ESPP | Maximum | |||||
Share-Based Compensation | |||||
Number of shares reserved for issuance under the Plan (in shares) | 1,000,000 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Basic and diluted net loss per common share calculation: | ||||
Net loss | $ (60,891) | $ (39,573) | $ (127,137) | $ (70,068) |
Weighted average common shares outstanding - basic and diluted (in shares) | 35,594 | 34,782 | 35,415 | 34,432 |
Net loss per share of common stock - basic and diluted (in dollars per share) | $ (1.71) | $ (1.14) | $ (3.59) | $ (2.03) |
Anti-dilutive securities | ||||
Total (in shares) | 4,144 | 3,509 | 4,144 | 3,509 |
Stock options outstanding | ||||
Anti-dilutive securities | ||||
Total (in shares) | 3,423 | 3,224 | 3,423 | 3,224 |
Restricted stock units | ||||
Anti-dilutive securities | ||||
Total (in shares) | 721 | 285 | 721 | 285 |
Cash, Cash Equivalents and Av32
Cash, Cash Equivalents and Available for Sale Securities (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2016 | Dec. 31, 2015 | |
Cash, Cash Equivalents, and Short-term Investments [Abstract] | ||
Cash | $ 5,500,000 | $ 5,500,000 |
Investments in money market funds, U.S. Treasury Securities and certain short-term investment-grade corporate debt securities with original maturities of 90 days or less | 160,100,000 | 216,400,000 |
Fair Value | 155,552,000 | 170,029,000 |
Available for sale securities with maturities of less than one year | 155,552,000 | 74,731,000 |
Available for sale securities with maturities of greater than one year | 0 | $ 95,298,000 |
Other than temporary losses in fair value, available for sale securities | $ 0 |
Cash, Cash Equivalents and Av33
Cash, Cash Equivalents and Available for Sale Securities - Summary of Available for Sale Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Available for sale securities, including carrying value and estimated fair values | ||
Cost | $ 155,513 | $ 170,502 |
Unrealized Gains | 57 | 0 |
Unrealized Losses | (18) | (473) |
Fair Value | 155,552 | 170,029 |
U.S. Treasury securities | ||
Available for sale securities, including carrying value and estimated fair values | ||
Cost | 120,280 | 130,507 |
Unrealized Gains | 47 | 0 |
Unrealized Losses | (7) | (311) |
Fair Value | 120,320 | 130,196 |
Corporate debt securities | ||
Available for sale securities, including carrying value and estimated fair values | ||
Cost | 35,233 | 39,995 |
Unrealized Gains | 10 | 0 |
Unrealized Losses | (11) | (162) |
Fair Value | $ 35,232 | $ 39,833 |
Cash, Cash Equivalents and Av34
Cash, Cash Equivalents and Available for Sale Securities - Schedule of Changes in Accumulated Other Comprehensive Income (Loss) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Changes in accumulated other comprehensive income (loss) | ||||
Beginning balance | $ 59,947 | |||
Current period changes in fair value before reclassifications, net of tax | $ (41) | $ 85 | 314 | $ 174 |
Amounts reclassified from accumulated other comprehensive income (loss), net of tax | 0 | (30) | 0 | (30) |
Other comprehensive income (loss) | (41) | 55 | 314 | 144 |
Ending balance | (36,589) | (36,589) | ||
Accumulated Other Comprehensive Income (Loss) | ||||
Changes in accumulated other comprehensive income (loss) | ||||
Beginning balance | (118) | 24 | (473) | (65) |
Ending balance | $ (159) | $ 79 | $ (159) | $ 79 |
Licensing and Commercializati35
Licensing and Commercialization Agreement with Novartis Pharma AG (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 22 Months Ended | |||||
Jun. 30, 2016USD ($) | Mar. 31, 2015USD ($) | Sep. 30, 2014USD ($) | May 31, 2014USD ($)milestone | Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2015USD ($) | Jun. 30, 2016USD ($) | |
Agreement | |||||||||
Total collaboration revenue | $ 1,668 | $ 3,448 | $ 45,587 | $ 46,723 | |||||
License revenue | |||||||||
Agreement | |||||||||
Total collaboration revenue | 0 | 0 | 22,937 | 38,083 | |||||
Research and development activity revenue | |||||||||
Agreement | |||||||||
Total collaboration revenue | 1,664 | 1,594 | 8,089 | 6,768 | |||||
API transfer revenue | |||||||||
Agreement | |||||||||
Total collaboration revenue | 0 | 1,851 | 14,545 | 1,851 | |||||
Joint operating committee revenue | |||||||||
Agreement | |||||||||
Total collaboration revenue | 4 | $ 3 | 16 | $ 21 | |||||
Licensing and Commercialization Agreement | Novartis Pharma AG | |||||||||
Agreement | |||||||||
Upfront fees received | $ 200,000 | ||||||||
Licensing and Commercialization Agreement | Novartis Pharma AG | Research and development activity revenue | |||||||||
Agreement | |||||||||
Deferred revenue | 211,800 | 211,800 | |||||||
Licensing and Commercialization Agreement | Novartis Pharma AG | Research and development activity revenue | Up-front payment | |||||||||
Agreement | |||||||||
Deferred revenue | 200,000 | 200,000 | |||||||
Licensing and Commercialization Agreement | Novartis Pharma AG | Research and development activity revenue | Ongoing performance obligations | |||||||||
Agreement | |||||||||
Deferred revenue | $ 11,800 | $ 11,800 | |||||||
Licensing and Commercialization Agreement | Novartis Pharma AG | Achievement of specified patient enrollment milestones | |||||||||
Agreement | |||||||||
Number of milestones | milestone | 2 | ||||||||
Patient enrollment-based milestone revenue achieved | $ 30,000 | $ 50,000 | $ 50,000 | $ 30,000 | $ 130,000 | ||||
Milestone payment received | 130,000 | $ 130,000 | |||||||
Licensing and Commercialization Agreement | Novartis Pharma AG | Achievement of specified patient enrollment milestones | Maximum | |||||||||
Agreement | |||||||||
Aggregate amount receivable on achievement of milestone | 50,000 | ||||||||
Licensing and Commercialization Agreement | Novartis Pharma AG | Achievement of specified regulatory approval milestones | Maximum | |||||||||
Agreement | |||||||||
Aggregate amount receivable on achievement of milestone | 300,000 | ||||||||
Licensing and Commercialization Agreement | Novartis Pharma AG | Achievement of specified commercial sale milestone | Maximum | |||||||||
Agreement | |||||||||
Aggregate amount receivable on achievement of milestone | $ 400,000 |
Financing Agreement with Novo36
Financing Agreement with Novo A/S (Details) | 1 Months Ended | 19 Months Ended | ||||
Nov. 30, 2014USD ($) | Jan. 31, 2014USD ($) | May 31, 2013USD ($)tranchepurchase | Nov. 30, 2014USD ($) | Sep. 30, 2016USD ($) | Dec. 31, 2015USD ($) | |
Agreement | ||||||
Royalty purchase liability | $ 125,000,000 | $ 125,000,000 | ||||
Novo A/S | Novo Agreement | Fovista, Fovista-Related Products, and Other Products | ||||||
Agreement | ||||||
Number of tranches in financing | tranche | 3 | |||||
Aggregate royalty rights | $ 125,000,000 | |||||
Number of separate purchases provided for in financing agreement | purchase | 3 | |||||
Proceeds from royalty purchase agreement | $ 41,700,000 | $ 41,700,000 | $ 41,700,000 | $ 125,000,000 | ||
Royalty purchase liability | $ 125,000,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Income Tax Disclosure [Abstract] | ||||
Federal and state tax liability, provision (benefit) from income taxes | $ 0.1 | $ (7.5) | $ (0.2) | $ (11.6) |
Discrete income tax provision (benefit) | 0.1 | $ (0.2) | ||
Reduction in deferred tax assets and corresponding valuation allowance | $ 3.8 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Sep. 30, 2016 | Dec. 31, 2015 |
Fair Value Measurements | ||
Investments in U.S. Treasury securities and Corporate debt securities | $ 155,552,000 | $ 170,029,000 |
Transfer of assets from Level 1 to Level 2 of the fair value measurement hierarchy | 0 | |
Transfer of assets from Level 2 to Level 1 of the fair value measurement hierarchy | 0 | |
Fair Value, Measurements, Recurring | Quoted prices in active markets for identical assets (Level 1) | Money market funds | ||
Fair Value Measurements | ||
Investments in money market funds and U.S. Treasury securities | 157,114,000 | 196,188,000 |
Fair Value, Measurements, Recurring | Quoted prices in active markets for identical assets (Level 1) | U.S. Treasury securities | ||
Fair Value Measurements | ||
Investments in money market funds and U.S. Treasury securities | 150,387,000 | |
Investments in U.S. Treasury securities and Corporate debt securities | 120,320,000 | |
Fair Value, Measurements, Recurring | Quoted prices in active markets for identical assets (Level 1) | Corporate debt securities | ||
Fair Value Measurements | ||
Investments in U.S. Treasury securities and Corporate debt securities | 0 | 0 |
Fair Value, Measurements, Recurring | Significant other observable inputs (Level 2) | Money market funds | ||
Fair Value Measurements | ||
Investments in money market funds and U.S. Treasury securities | 0 | 0 |
Fair Value, Measurements, Recurring | Significant other observable inputs (Level 2) | U.S. Treasury securities | ||
Fair Value Measurements | ||
Investments in money market funds and U.S. Treasury securities | 0 | |
Investments in U.S. Treasury securities and Corporate debt securities | 0 | |
Fair Value, Measurements, Recurring | Significant other observable inputs (Level 2) | Corporate debt securities | ||
Fair Value Measurements | ||
Investments in U.S. Treasury securities and Corporate debt securities | 38,225,000 | 39,833,000 |
Fair Value, Measurements, Recurring | Significant unobservable inputs (Level 3) | Money market funds | ||
Fair Value Measurements | ||
Investments in money market funds and U.S. Treasury securities | 0 | 0 |
Fair Value, Measurements, Recurring | Significant unobservable inputs (Level 3) | U.S. Treasury securities | ||
Fair Value Measurements | ||
Investments in money market funds and U.S. Treasury securities | 0 | |
Investments in U.S. Treasury securities and Corporate debt securities | 0 | |
Fair Value, Measurements, Recurring | Significant unobservable inputs (Level 3) | Corporate debt securities | ||
Fair Value Measurements | ||
Investments in U.S. Treasury securities and Corporate debt securities | $ 0 | $ 0 |
Stock Option and Compensation39
Stock Option and Compensation Plans - Stock Incentive Plans and Stock Option Activity Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | Jan. 01, 2016 | Jan. 01, 2015 | Jan. 01, 2014 | Apr. 30, 2016 | Aug. 31, 2013 | Sep. 30, 2016 |
Options outstanding, net of estimated forfeitures, vested or expected to vest | ||||||
Options outstanding (in shares) | 3,198,000 | |||||
Weighted-average exercise price (in dollars per share) | $ 39.42 | |||||
Weighted average remaining contractual life | 7 years 9 months 16 days | |||||
Aggregate intrinsic value | $ 35.2 | |||||
2007 Plan | ||||||
Stock Option and Compensation Plans | ||||||
Number of shares of common stock available for issuance under the Plan (in shares) | 739,317 | |||||
2013 Plan | ||||||
Stock Option and Compensation Plans | ||||||
Number of shares of common stock available for issuance under the Plan (in shares) | 1,048,000 | |||||
Annual increase in shares reserved for issuance under the Plan (in shares) | 2,542,372 | |||||
Annual increase in shares reserved for issuance under the Plan (as a percent) | 4.00% | |||||
Increase in number of shares available under the Plan (in shares) | 1,408,000 | 1,360,000 | 1,257,000 | |||
2013 Plan | Maximum | ||||||
Stock Option and Compensation Plans | ||||||
Number of shares reserved for issuance under the Plan (in shares) | 3,359,641 | |||||
ESPP | ||||||
Stock Option and Compensation Plans | ||||||
Purchase price of common stock as percentage of fair market value | 85.00% | |||||
ESPP | Maximum | ||||||
Stock Option and Compensation Plans | ||||||
Number of shares reserved for issuance under the Plan (in shares) | 1,000,000 |
Stock Option and Compensation40
Stock Option and Compensation Plans - Summary of Stock Option Activity (Details) shares in Thousands | 9 Months Ended |
Sep. 30, 2016$ / sharesshares | |
Common Stock Options | |
Outstanding, December 31, 2015 (in shares) | shares | 3,009 |
Granted (in shares) | shares | 952 |
Exercised (in shares) | shares | (350) |
Expired or forfeited (in shares) | shares | (188) |
Outstanding, September 30, 2016 (in shares) | shares | 3,423 |
Weighted Average Exercise Price | |
Outstanding, December 31, 2015 (in dollars per share) | $ / shares | $ 30.43 |
Granted (in dollars per share) | $ / shares | 60.81 |
Exercised (in dollars per share) | $ / shares | 16.89 |
Expired or forfeited (in dollars per share) | $ / shares | 48.59 |
Outstanding, September 30, 2016 (in dollars per share) | $ / shares | $ 39.26 |
Options exercisable at September 30, 2016 (in shares) | shares | 1,399 |
Weighted average grant date fair value (per share) of options granted during the period (in dollars per share) | $ / shares | $ 38.49 |
Stock Option and Compensation41
Stock Option and Compensation Plans - Options Outstanding and Exercisable by Exercise Price and Options Exercised (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 9 Months Ended |
Sep. 30, 2016USD ($)$ / sharesshares | |
Options Outstanding | |
Total Options Outstanding (in shares) | shares | 3,423 |
Weighted Average Remaining Life (Years) | 7 years 9 months 21 days |
Weighted Average Exercise Price (in dollars per share) | $ 39.26 |
Aggregate Intrinsic Value of Options Outstanding | $ | $ 38,226 |
Options Exercisable | |
Number Exercisable (in shares) | shares | 1,399 |
Weighted Average Exercise Price (in dollars per share) | $ 30.18 |
Aggregate Intrinsic Value of Options Exercisable | $ | $ 23,077 |
$0.12-$10.03 | |
Options Outstanding | |
Total Options Outstanding (in shares) | shares | 257 |
Weighted Average Remaining Life (Years) | 5 years 7 months 6 days |
Weighted Average Exercise Price (in dollars per share) | $ 6.77 |
Options Exercisable | |
Number Exercisable (in shares) | shares | 158 |
Weighted Average Exercise Price (in dollars per share) | $ 4.74 |
Exercise prices, low end of range (in dollars per share) | 0.12 |
Exercise prices, high end of range (in dollars per share) | $ 10.03 |
$10.04-$20.00 | |
Options Outstanding | |
Total Options Outstanding (in shares) | shares | 274 |
Weighted Average Remaining Life (Years) | 6 years 8 months 26 days |
Weighted Average Exercise Price (in dollars per share) | $ 13.44 |
Options Exercisable | |
Number Exercisable (in shares) | shares | 151 |
Weighted Average Exercise Price (in dollars per share) | $ 13.48 |
Exercise prices, low end of range (in dollars per share) | 10.04 |
Exercise prices, high end of range (in dollars per share) | $ 20 |
$20.01-$30.00 | |
Options Outstanding | |
Total Options Outstanding (in shares) | shares | 154 |
Weighted Average Remaining Life (Years) | 7 years 1 month 6 days |
Weighted Average Exercise Price (in dollars per share) | $ 25.56 |
Options Exercisable | |
Number Exercisable (in shares) | shares | 102 |
Weighted Average Exercise Price (in dollars per share) | $ 25.51 |
Exercise prices, low end of range (in dollars per share) | 20.01 |
Exercise prices, high end of range (in dollars per share) | $ 30 |
$30.01-$40.00 | |
Options Outstanding | |
Total Options Outstanding (in shares) | shares | 1,093 |
Weighted Average Remaining Life (Years) | 6 years 11 months 3 days |
Weighted Average Exercise Price (in dollars per share) | $ 32.67 |
Options Exercisable | |
Number Exercisable (in shares) | shares | 699 |
Weighted Average Exercise Price (in dollars per share) | $ 33.05 |
Exercise prices, low end of range (in dollars per share) | 30.01 |
Exercise prices, high end of range (in dollars per share) | $ 40 |
$40.01-$55.00 | |
Options Outstanding | |
Total Options Outstanding (in shares) | shares | 1,115 |
Weighted Average Remaining Life (Years) | 8 years 10 months 1 day |
Weighted Average Exercise Price (in dollars per share) | $ 46.24 |
Options Exercisable | |
Number Exercisable (in shares) | shares | 267 |
Weighted Average Exercise Price (in dollars per share) | $ 45.65 |
Exercise prices, low end of range (in dollars per share) | 40.01 |
Exercise prices, high end of range (in dollars per share) | $ 55 |
$55.01-$73.22 | |
Options Outstanding | |
Total Options Outstanding (in shares) | shares | 530 |
Weighted Average Remaining Life (Years) | 9 years 3 months 16 days |
Weighted Average Exercise Price (in dollars per share) | $ 71.26 |
Options Exercisable | |
Number Exercisable (in shares) | shares | 22 |
Weighted Average Exercise Price (in dollars per share) | $ 70.28 |
Exercise prices, low end of range (in dollars per share) | 55.01 |
Exercise prices, high end of range (in dollars per share) | $ 73.22 |
Stock Option and Compensation42
Stock Option and Compensation Plans - Schedule of Cash Proceeds From and Aggregate Intrinsic Value of Stock Options Exercised (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||
Cash proceeds from options exercised | $ 1,591 | $ 1,813 | $ 5,398 | $ 6,024 |
Aggregate intrinsic value of options exercised | $ 5,185 | $ 10,092 | $ 12,607 | $ 39,033 |
Stock Option and Compensation43
Stock Option and Compensation Plans - Stock Compensation Expense (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Stock Option and Compensation Plans | ||||
Share-based compensation expense | $ 8,248 | $ 7,041 | $ 24,889 | $ 18,474 |
ESPP | ||||
Stock Option and Compensation Plans | ||||
Expected weighted average period to recognize share-based compensation costs | 6 months | |||
Unrecognized compensation costs, net of estimated forfeitures | 300 | $ 300 | ||
Stock options | Employees | ||||
Stock Option and Compensation Plans | ||||
Share-based compensation expense | 5,600 | 3,400 | 17,300 | 11,400 |
Unrecognized share-based compensation costs for option awards, net of estimated forfeitures | 48,300 | $ 48,300 | ||
Expected weighted average period to recognize share-based compensation costs | 2 years 8 months 7 days | |||
Non-employee Options | Consultants | ||||
Stock Option and Compensation Plans | ||||
Share-based compensation expense | 600 | 1,800 | $ 1,500 | 3,400 |
Unrecognized share-based compensation costs for option awards, net of estimated forfeitures | $ 1,400 | $ 1,400 | ||
Expected weighted average period to recognize share-based compensation costs | 1 year 5 months 8 days | |||
Restricted stock units | ||||
Stock Option and Compensation Plans | ||||
RSUs expected to vest (in shares) | 513 | 513 | ||
Weighted-average fair value of RSUs expected to vest (in dollars per share) | $ 54.45 | $ 54.45 | ||
Aggregate intrinsic value of RSUs expected to vest | $ 23,700 | $ 23,700 | ||
Restricted stock units | Employees | ||||
Stock Option and Compensation Plans | ||||
Share-based compensation expense | 2,000 | $ 1,800 | $ 6,100 | $ 3,700 |
Expected weighted average period to recognize share-based compensation costs | 2 years 6 months 4 days | |||
Unrecognized compensation costs, net of estimated forfeitures | $ 31,700 | $ 31,700 |
Stock Option and Compensation44
Stock Option and Compensation Plans - Summary of Outstanding RSU Awards Granted (Details) - Restricted stock units shares in Thousands | 9 Months Ended |
Sep. 30, 2016$ / sharesshares | |
Restricted Stock Units | |
Outstanding, December 31, 2015 (in shares) | shares | 288 |
Awarded (in shares) | shares | 574 |
Vested (in shares) | shares | (103) |
Forfeited (in shares) | shares | (38) |
Outstanding, September 30, 2016 (in shares) | shares | 721 |
Weighted Average Grant-Date Fair Value | |
Outstanding, December 31, 2015 (in dollars per share) | $ / shares | $ 44.54 |
Awarded (in dollars per share) | $ / shares | 58.43 |
Vested (in dollars per share) | $ / shares | 44.07 |
Forfeited (in dollars per share) | $ / shares | 50.84 |
Outstanding, September 30, 2016 (in dollars per share) | $ / shares | $ 55.32 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | |
Property and Equipment | |||||
Property and equipment, gross | $ 4,612 | $ 4,612 | $ 4,365 | ||
Accumulated depreciation | (1,438) | (1,438) | (899) | ||
Property and equipment, net | 3,174 | 3,174 | 3,466 | ||
Depreciation expense | 186 | $ 77 | $ 539 | $ 535 | |
Minimum | |||||
Property and Equipment | |||||
Useful life | 3 years | ||||
Maximum | |||||
Property and Equipment | |||||
Useful life | 10 years | ||||
Manufacturing and clinical equipment | |||||
Property and Equipment | |||||
Property and equipment, gross | 617 | $ 617 | 617 | ||
Manufacturing and clinical equipment | Minimum | |||||
Property and Equipment | |||||
Useful life | 7 years | ||||
Manufacturing and clinical equipment | Maximum | |||||
Property and Equipment | |||||
Useful life | 10 years | ||||
Computer, software and other office equipment | |||||
Property and Equipment | |||||
Useful life | 5 years | ||||
Property and equipment, gross | 1,621 | $ 1,621 | 944 | ||
Furniture and fixtures | |||||
Property and Equipment | |||||
Useful life | 7 years | ||||
Property and equipment, gross | 774 | $ 774 | 738 | ||
Leasehold improvements | |||||
Property and Equipment | |||||
Property and equipment, gross | 1,600 | $ 1,600 | 1,551 | ||
Leasehold improvements | Minimum | |||||
Property and Equipment | |||||
Useful life | 3 years | ||||
Leasehold improvements | Maximum | |||||
Property and Equipment | |||||
Useful life | 5 years | ||||
Construction-in-progress | |||||
Property and Equipment | |||||
Property and equipment, gross | $ 0 | $ 0 | $ 515 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | 1 Months Ended | |
Jun. 30, 2014 | Sep. 30, 2016 | |
AVEO | Tivozanib | Submission of Investigational New Drug application | ||
Commitments and contingencies | ||
Amount to be paid on achievement of milestone | $ 2,000,000 | |
AVEO | Tivozanib | Demonstration of proof of concept in humans | ||
Commitments and contingencies | ||
Amount to be paid on achievement of milestone | 6,000,000 | |
Acquisition agreement | OSI Pharmaceuticals | PDGF Licensed Products | ||
Commitments and contingencies | ||
Amount to be paid on achievement of milestone | 12,000,000 | |
License Agreements | Archemix | PDGF Licensed Products | ||
Commitments and contingencies | ||
Royalty payable | 0 | |
License Agreements | Archemix | Fovista | Achievement of specified clinical and regulatory milestones | Maximum | ||
Commitments and contingencies | ||
Amount to be paid on achievement of milestone | 14,000,000 | |
License Agreements | Archemix | Fovista | Achievement of specified commercial milestones | Maximum | ||
Commitments and contingencies | ||
Amount to be paid on achievement of milestone | 3,000,000 | |
License Agreements | Archemix | Other anti-PDGF aptamer | Achievement of specified clinical and regulatory milestones | Maximum | ||
Commitments and contingencies | ||
Amount to be paid on achievement of milestone | 18,800,000 | |
License Agreements | Archemix | Other anti-PDGF aptamer | Achievement of specified commercial milestones | Maximum | ||
Commitments and contingencies | ||
Amount to be paid on achievement of milestone | 3,000,000 | |
License Agreements | Archemix | C5 Licensed Product | ||
Commitments and contingencies | ||
Royalty payable | 0 | |
License Agreements | Archemix | C5 Licensed Product | Achievement of specified commercial milestones | Maximum | ||
Commitments and contingencies | ||
Amount to be paid on achievement of milestone | 22,500,000 | |
License Agreements | Archemix | C5 Licensed Product | Achievement of specified development, clinical and regulatory milestones | Maximum | ||
Commitments and contingencies | ||
Amount to be paid on achievement of milestone | 57,500,000 | |
License Agreements | Althea | Achievement of certain validation and production milestones | Maximum | ||
Commitments and contingencies | ||
Amount to be paid on achievement of milestone | 14,400,000 | |
Supply Agreement | Nektar | ||
Commitments and contingencies | ||
Payment upon entry into Novartis Agreement | $ 19,800,000 | |
Supply Agreement | Nektar | Fovista | Achievement of specified clinical and regulatory milestones | Maximum | ||
Commitments and contingencies | ||
Amount to be paid on achievement of milestone | 6,500,000 | |
Supply Agreement | Nektar | Fovista | Achievement of specified commercial milestones | Maximum | ||
Commitments and contingencies | ||
Amount to be paid on achievement of milestone | $ 3,000,000 |
Subsequent Event (Details)
Subsequent Event (Details) $ in Millions | 1 Months Ended | ||
Oct. 31, 2016USD ($) | Nov. 08, 2016USD ($) | Sep. 30, 2016trial | |
Patient enrollment for Phase 3 Clinical Trials | |||
Subsequent Event [Line Items] | |||
Number of trials completed | trial | 2 | ||
Subsequent Event | |||
Subsequent Event [Line Items] | |||
Termination period for Fill/Finish Capacity Reservation Agreement | 30 days | ||
Subsequent Event | License Agreements | Althea | |||
Subsequent Event [Line Items] | |||
Non-refundable capacity reservation fee payments made | $ 1.6 | ||
Subsequent Event | License Agreements | Althea | Maximum | |||
Subsequent Event [Line Items] | |||
Aggregate amount of capacity reservation fee payment commitments | $ 16 |