Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Jun. 30, 2016 | Aug. 18, 2016 | Dec. 31, 2015 | |
Document and Entity Information | |||
Entity Registrant Name | IMMUNOGEN INC | ||
Entity Central Index Key | 855,654 | ||
Document Type | 10-K | ||
Document Period End Date | Jun. 30, 2016 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --06-30 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Public Float | $ 1,176,154,266 | ||
Entity Common Stock, Shares Outstanding | 87,326,441 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2016 | Jun. 30, 2015 |
ASSETS | ||
Cash and cash equivalents | $ 245,026 | $ 278,109 |
Accounts receivable | 883 | 5,088 |
Unbilled revenue | 1,409 | 714 |
Inventory | 907 | 2,935 |
Current portion of deferred financing costs | 1,674 | 1,159 |
Prepaid and other current assets | 4,881 | 4,175 |
Total current assets | 254,780 | 292,180 |
Property and equipment, net of accumulated depreciation | 22,704 | 16,254 |
Deferred financing costs, net of current portion | 6,171 | 4,415 |
Other assets | 3,430 | 974 |
Total assets | 287,085 | 313,823 |
LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY | ||
Accounts payable | 11,510 | 8,138 |
Accrued compensation | 10,724 | 8,346 |
Other accrued liabilities | 9,713 | 10,441 |
Current portion of deferred lease incentive | 772 | 646 |
Current portion of liability related to the sale of future royalties | 15,138 | 7,906 |
Current portion of deferred revenue | 13,582 | 333 |
Total current liabilities | 61,439 | 35,810 |
Deferred lease incentive, net of current portion | 6,236 | 6,301 |
Deferred revenue, net of current portion | 19,288 | 40,855 |
Convertible 4.5% senior notes | 100,000 | |
Liability related to the sale of future royalties, net of current portion | 178,234 | 191,756 |
Other long-term liabilities | 4,192 | 3,997 |
Total liabilities | 369,389 | 278,719 |
Commitments and contingencies | ||
Shareholders' (deficit) equity: | ||
Preferred stock, $0.01 par value; authorized 5,000 shares; no shares issued and outstanding | ||
Common stock, $0.01 par value; authorized 150,000 shares; issued and outstanding 87,209 and 86,579 shares as of June 30, 2016 and June 30, 2015, respectively | 872 | 866 |
Additional paid-in capital | 770,511 | 743,108 |
Accumulated deficit | (853,687) | (708,870) |
Total shareholders' (deficit) equity | (82,304) | 35,104 |
Total liabilities and shareholders' (deficit) equity | $ 287,085 | $ 313,823 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands | Jun. 30, 2016 | Jun. 30, 2015 |
CONSOLIDATED BALANCE SHEETS | ||
Interest rate (as a percent) | 4.50% | |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, authorized shares | 5,000 | 5,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, authorized shares | 150,000 | 150,000 |
Common stock, issued shares | 87,209 | 86,579 |
Common stock, outstanding shares | 87,209 | 86,579 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | |
Revenues: | |||
License and milestone fees | $ 26,915 | $ 57,815 | $ 39,455 |
Royalty revenue | 195 | 13,867 | 10,346 |
Non-cash royalty revenue related to the sale of future royalties | 25,299 | 5,484 | |
Research and development support | 4,014 | 2,848 | 7,187 |
Clinical materials revenue | 3,579 | 5,527 | 2,908 |
Total revenues | 60,002 | 85,541 | 59,896 |
Operating Expenses: | |||
Research and development | 148,077 | 111,768 | 106,958 |
General and administrative | 36,916 | 28,228 | 24,469 |
Total operating expenses | 184,993 | 139,996 | 131,427 |
(Loss) income from operations | (124,991) | (54,455) | (71,531) |
Investment income, net | 325 | 69 | 44 |
Non-cash interest expense on liability related to the sale of future royalties and convertible senior notes | (20,130) | (5,437) | |
Other income (expense), net | (21) | (916) | 123 |
Net (loss) income | $ (144,817) | $ (60,739) | $ (71,364) |
Basic and diluted net (loss) income per common share (in dollars per share) | $ (1.67) | $ (0.71) | $ (0.83) |
Basic and diluted weighted average common shares outstanding (in shares) | 86,976 | 86,038 | 85,481 |
Total comprehensive (loss) income | $ (144,817) | $ (60,739) | $ (71,364) |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' (DEFICIT) EQUITY - USD ($) shares in Thousands, $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at Jun. 30, 2013 | $ 847 | $ 697,767 | $ (576,767) | $ 121,847 |
Balance (in shares) at Jun. 30, 2013 | 84,725 | |||
Increase (Decrease) in Shareholders' (Deficit) Equity | ||||
Net loss | (71,364) | (71,364) | ||
Stock options exercised | $ 11 | 9,125 | 9,136 | |
Stock options exercised (in shares) | 1,134 | |||
Stock option and restricted stock compensation expense | 15,647 | 15,647 | ||
Directors' deferred share units converted | $ 1 | (1) | ||
Directors' deferred share units converted (in shares) | 44 | |||
Directors' deferred share unit compensation | 433 | 433 | ||
Balance at Jun. 30, 2014 | $ 859 | 722,971 | (648,131) | 75,699 |
Balance (in shares) at Jun. 30, 2014 | 85,903 | |||
Increase (Decrease) in Shareholders' (Deficit) Equity | ||||
Net loss | (60,739) | (60,739) | ||
Stock options exercised | $ 7 | 4,422 | 4,429 | |
Stock options exercised (in shares) | 651 | |||
Restricted stock award (in shares) | 25 | |||
Stock option and restricted stock compensation expense | 15,326 | 15,326 | ||
Directors' deferred share unit compensation | 389 | 389 | ||
Balance at Jun. 30, 2015 | $ 866 | 743,108 | (708,870) | $ 35,104 |
Balance (in shares) at Jun. 30, 2015 | 86,579 | 86,579 | ||
Increase (Decrease) in Shareholders' (Deficit) Equity | ||||
Net loss | (144,817) | $ (144,817) | ||
Stock options exercised | $ 5 | 5,156 | 5,161 | |
Stock options exercised (in shares) | 555 | |||
Restricted stock award | $ 1 | (1) | ||
Restricted stock award (in shares) | 75 | |||
Stock option and restricted stock compensation expense | 21,868 | 21,868 | ||
Directors' deferred share unit compensation | 380 | 380 | ||
Balance at Jun. 30, 2016 | $ 872 | $ 770,511 | $ (853,687) | $ (82,304) |
Balance (in shares) at Jun. 30, 2016 | 87,209 | 87,209 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | |
Cash flows from operating activities: | |||
Net loss | $ (144,817) | $ (60,739) | $ (71,364) |
Adjustments to reconcile net loss to net cash used for operating activities: | |||
Non-cash royalty revenue related to sale of future royalties | (25,299) | (5,484) | |
Non-cash interest expense on liability related to sale of future royalties and convertible senior notes | 20,130 | 5,437 | |
Depreciation and amortization | 5,327 | 5,513 | 4,598 |
(Gain) Loss on sale/disposal of fixed assets | (21) | 7 | 20 |
Gain on forward contracts | (2) | ||
Non-cash licensing fee | 12,830 | ||
Stock and deferred share unit compensation | 22,248 | 15,715 | 16,080 |
Deferred rent | 161 | 195 | 297 |
Change in operating assets and liabilities: | |||
Accounts receivable | 4,205 | (3,192) | (1,896) |
Unbilled revenue | (695) | 615 | 792 |
Inventory | 2,028 | 15 | (2,247) |
Prepaid and other current assets | (706) | (1,855) | 571 |
Restricted cash | 2,231 | ||
Other assets | (2,456) | (761) | 4 |
Accounts payable | 2,649 | 3,319 | 321 |
Accrued compensation | 2,378 | 1,481 | 712 |
Other accrued liabilities | (1,434) | 3,248 | (394) |
Deferred revenue | (8,318) | (20,155) | (16,675) |
Proceeds from landlord for tenant improvements | 144 | 1,350 | 472 |
Net cash used for operating activities | (124,476) | (55,291) | (53,650) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (10,376) | (7,425) | (8,184) |
Payments from settlement of forward contracts | (1) | ||
Net cash used for investing activities | (10,376) | (7,425) | (8,185) |
Cash flows from financing activities: | |||
Proceeds from stock options exercised | 5,161 | 4,429 | 9,136 |
Proceeds from sale of future royalties, net of $5,865 of transaction costs | 194,135 | ||
Proceeds from issuance of convertible 4.5% notes, net of $3,392 of transaction costs | 96,608 | ||
Net cash provided by financing activities | 101,769 | 198,564 | 9,136 |
Net change in cash and cash equivalents | (33,083) | 135,848 | (52,699) |
Cash and cash equivalents, beginning balance | 278,109 | 142,261 | 194,960 |
Cash and cash equivalents, ending balance | $ 245,026 | $ 278,109 | $ 142,261 |
CONSOLIDATED STATEMENTS OF CAS7
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) $ in Thousands | 12 Months Ended |
Jun. 30, 2016USD ($) | |
CONSOLIDATED STATEMENTS OF CASH FLOWS | |
Transaction costs for royalty agreements | $ 5,865 |
Interest rate (as a percent) | 4.50% |
Issuance of debt transaction costs | $ 3,392 |
Nature of Business and Plan of
Nature of Business and Plan of Operations | 12 Months Ended |
Jun. 30, 2016 | |
Nature of Business and Plan of Operations | |
Nature of Business and Plan of Operations | A. Nature of Business and Plan of Operations ImmunoGen, Inc. (the Company) was incorporated in Massachusetts in 1981 and is focused on the development of antibody ‑based anticancer therapeutics. The Company has incurred operating losses and negative cash flows from operations since inception, incurred a net loss of approximately $144.8 million during the fiscal year ended June 30, 2016, and has an accumulated deficit of approximately $ 853.7 m illion as of June 30, 2016. The Company has primarily funded these losses through payments received from its collaborations and equity and convertible debt financings. To date, the Company has no product revenue and management expects operating losses to continue for the foreseeable future. At June 30, 2016, the Company had $245 million of cash and cash equivalents on hand. The Company anticipates that its current capital resources and expected future collaborator payments under existing collaborations will enable it to meet its operational expenses and capital expenditures through approximately December 2017. The Company may raise additional funds through equity or debt financings or generate revenues from collaborative partners through a combination of upfront license payments, milestone payments, royalty payments, research funding, and clinical material reimbursement. There can be no assurance that the Company will be able to obtain additional debt or equity financing or generate revenues from collaborative partners on terms acceptable to the Company or at all. The failure of the Company to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on the Company’s business, results of operations and financial condition and require the Company to defer or limit some or all of its research, development and/or clinical projects. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, the development by its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, manufacturing and marketing limitations, collaboration arrangements, third ‑party reimbursements and compliance with governmental regulations. On June 15, 2016 the company’s Board of Directors approved a change in the Company’s fiscal year from a fiscal year ending on the last day of June of each year to a calendar fiscal year ending on the last day of December of each year, effective January 1, 2017. Accordingly the Company will be issuing six month transitional financial statements as of December 31, 2016, and calendar year financial statements thereafter. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Jun. 30, 2016 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | B. Summary of Significant Accounting Policies Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, ImmunoGen Securities Corp., ImmunoGen Europe Limited and Hurricane, LLC. All intercompany transactions and balances have been eliminated. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States (U.S.) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Subsequent Events The Company has evaluated all events or transactions that occurred after June 30, 2016 up through the date the Company issued these financial statements. The Company did not have any material recognizable or unrecognizable subsequent events. Related party transaction During fiscal year 2016, the Company entered into a transaction with Sanofi to purchase drug product along with the master and working cell banks for a product that Sanofi previously discontinued and had returned its rights back to the Company. The Company entered into this transaction, at a cost of €1.6 million, in order to continue development of the product, or make it more attractive to re-license the target to another partner. A relationship between an executive from the Company and an executive from Sanofi qualified this transaction as potentially between related parties, and accordingly, the audit committee of the Board of Directors of the Company approved the terms and conditions of the transaction, believing that it was in the best interest of the Company to proceed and that it was done at an arms-length amount. The transaction was substantially completed during the year; however, as of June 30, 2016, $44,000 is classified as a prepaid expense and approximately $258,000 more will be payable when a deliverable still pending from Sanofi is received. Revenue Recognition The Company enters into licensing and development agreements with collaborative partners for the development of monoclonal antibody ‑based anticancer therapeutics. The terms of these agreements contain multiple deliverables which may include (i) licenses, or options to obtain licenses, to the Company’s antibody ‑drug conjugate, or ADC, technology, (ii) rights to future technological improvements, (iii) research activities to be performed on behalf of the collaborative partner, (iv) delivery of cytotoxic agents and (v) the manufacture of preclinical or clinical materials for the collaborative partner. Payments to the Company under these agreements may include upfront fees, option fees, exercise fees, payments for research activities, payments for the manufacture of preclinical or clinical materials, payments based upon the achievement of certain milestones and royalties on product sales. The Company follows the provisions of the Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 605 ‑25, “Revenue Recognition—Multiple ‑Element Arrangements,” and ASC Topic 605 ‑28, “Revenue Recognition—Milestone Method,” in accounting for these agreements. In order to account for these agreements, the Company must identify the deliverables included within the agreement and evaluate which deliverables represent separate units of accounting based on whether certain criteria are met, including whether the delivered element has stand ‑alone value to the collaborator. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. At June 30, 2016, the Company had the following two types of agreements with the parties identified below: · Development and commercialization licenses, which provide the party with the right to use the Company’s ADC technology and/or certain other intellectual property to develop compounds to a specified antigen target: Amgen ( two exclusive single-target licenses (1) ) Bayer ( one exclusive single-target license) Biotest ( one exclusive single-target license) CytomX ( one exclusive single-target license) Lilly ( three exclusive single-target licenses) Novartis ( five exclusive single-target licenses and one license to two related targets: one target on an exclusive basis and the second target on a non-exclusive basis) Roche, through its Genentech unit ( five exclusive single-target licenses) Sanofi ( one exclusive single-target license and one exclusive license to multiple individual targets) Takeda, through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc. ( one exclusive single-target license) (1) Amgen has sublicensed one of its exclusive single-target licenses to Oxford BioTherapeutics Ltd. · Research license/option agreement for a defined period of time to secure development and commercialization licenses to use the Company’s ADC technology to develop anticancer compounds to specified targets on established terms (referred to herein as right-to-test agreements): CytomX Takeda, through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc. There are no performance, cancellation, termination or refund provisions in any of the arrangements that contain material financial consequences to the Company. Development and Commercialization Licenses The deliverables under a development and commercialization license agreement generally include the license to the Company’s ADC technology with respect to a specified antigen target, and may also include deliverables related to rights to future technological improvements, research activities to be performed on behalf of the collaborative partner and the manufacture of preclinical or clinical materials for the collaborative partner. Generally, development and commercialization licenses contain non ‑refundable terms for payments and, depending on the terms of the agreement, provide that the Company will (i) at the collaborator’s request, provide research services at negotiated prices which are generally consistent with what other third parties would charge, (ii) at the collaborator’s request, manufacture and provide to it preclinical and clinical materials or deliver cytotoxic agents at negotiated prices which are generally consistent with what other third parties would charge, (iii) earn payments upon the achievement of certain milestones and (iv) earn royalty payments, generally until the later of the last applicable patent expiration or 10 to 12 years after product launch. In the case of Kadcyla, however, the minimum royalty term is 10 years and the maximum royalty term is 12 years on a country ‑by ‑country basis, regardless of patent protection. Royalty rates may vary over the royalty term depending on the Company’s intellectual property rights and/or the presence of comparable competing products. The Company may provide technical assistance and share any technology improvements with its collaborators during the term of the collaboration agreements. The Company does not directly control when or whether any collaborator will request research or manufacturing services, achieve milestones or become liable for royalty payments. As a result, the Company cannot predict when or if it will recognize revenues in connection with any of the foregoing. In determining the units of accounting, management evaluates whether the license has stand ‑alone value from the undelivered elements to the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research capabilities of the partner and the availability of ADC technology research expertise in the general marketplace. If the Company concludes that the license has stand ‑alone value and therefore will be accounted for as a separate unit of accounting, the Company then determines the estimated selling prices of the license and all other units of accounting based on market conditions, similar arrangements entered into by third parties, and entity ‑specific factors such as the terms of the Company’s previous collaborative agreements, recent preclinical and clinical testing results of therapeutic products that use the Company’s ADC technology, the Company’s pricing practices and pricing objectives, the likelihood that technological improvements will be made, and, if made, will be used by the Company’s collaborators and the nature of the research services to be performed on behalf of its collaborators and market rates for similar services. Upfront payments on development and commercialization licenses may be recognized upon delivery of the license if facts and circumstances dictate that the license has stand ‑alone value from the undelivered elements, which generally include rights to future technological improvements, research services, delivery of cytotoxic agents and the manufacture of preclinical and clinical materials. The Company recognizes revenue related to research services that represent separate units of accounting as they are performed, as long as there is persuasive evidence of an arrangement, the fee is fixed or determinable, and collection of the related receivable is probable. The Company recognizes revenue related to the rights to future technological improvements over the estimated term of the applicable license. The Company may also provide cytotoxic agents to its collaborators or produce preclinical and clinical materials at negotiated prices which are generally consistent with what other third parties would charge. The Company recognizes revenue on cytotoxic agents and on preclinical and clinical materials when the materials have passed all quality testing required for collaborator acceptance and title and risk of loss have transferred to the collaborator. Arrangement consideration allocated to the manufacture of preclinical and clinical materials in a multiple ‑deliverable arrangement is below the Company’s full cost, and the Company’s full cost is not expected to ever be below its contract selling prices for its existing collaborations. During the fiscal years ended June 30, 2016, 2015 and 2014, the difference between the Company’s full cost to manufacture preclinical and clinical materials on behalf of its collaborators as compared to total amounts received from collaborators for the manufacture of preclinical and clinical materials was $ 6.9 million, $9.2 million and $2.3 million, respectively. The majority of the Company’s costs to produce these preclinical and clinical materials are fixed and then allocated to each batch based on the number of batches produced during the period. Therefore, the Company’s costs to produce these materials are significantly impacted by the number of batches produced during the period. The volume of preclinical and clinical materials the Company produces is directly related to the number of clinical trials the Company and its collaborators are preparing for or currently have underway, the speed of enrollment in those trials, the dosage schedule of each clinical trial and the time period such trials last. Accordingly, the volume of preclinical and clinical materials produced, and therefore the Company’s per ‑batch costs to manufacture these preclinical and clinical materials, may vary significantly from period to period. The Company may also produce research material for potential collaborators under material transfer agreements. Additionally, the Company performs research activities, including developing antibody specific conjugation processes, on behalf of its collaborators and potential collaborators during the early evaluation and preclinical testing stages of drug development. The Company records amounts received for research materials produced or services performed as a component of research and development support revenue. The Company also develops conjugation processes for materials for later stage testing and commercialization for certain collaborators. The Company is compensated at negotiated rates and may receive milestone payments for developing these processes which are recorded as a component of research and development support revenue. The Company’s development and commercialization license agreements have milestone payments which for reporting purposes are aggregated into three categories: (i) development milestones, (ii) regulatory milestones, and (iii) sales milestones. Development milestones are typically payable when a product candidate initiates or advances into different clinical trial phases. Regulatory milestones are typically payable upon submission for marketing approval with the U.S. Food and Drug Administration, or FDA, or other countries’ regulatory authorities or on receipt of actual marketing approvals for the compound or for additional indications. Sales milestones are typically payable when annual sales reach certain levels. At the inception of each agreement that includes 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. Non ‑refundable development and regulatory milestones that are expected to be achieved as a result of the Company’s efforts during the period of substantial involvement are considered substantive and are recognized as revenue upon the achievement of the milestone, assuming all other revenue recognition criteria are met. Milestones that are not considered substantive because we do not contribute effort to the achievement of such milestones are generally achieved after the period of substantial involvement and are recognized as revenue upon achievement of the milestone, as there are no undelivered elements remaining and no continuing performance obligations, assuming all other revenue recognition criteria are met. Under the Company’s development and commercialization license agreements, the Company receives royalty payments based upon its licensees’ net sales of covered products. Generally, under these agreements the Company is to receive royalty reports and payments from its licensees approximately one quarter in arrears, that is, generally in the second or third month of the quarter after the licensee has sold the royalty bearing product or products. The Company recognizes royalty revenues when it can reliably estimate such amounts and collectability is reasonably assured. As such, the Company generally recognizes royalty revenues in the quarter reported to the Company by its licensees, or one quarter following the quarter in which sales by the Company’s licensees occurred. Right ‑to ‑Test Agreements The Company’s right ‑to ‑test agreements provide collaborators the right to (a) test the Company’s ADC technology for a defined period of time through a research, or right ‑to ‑test, license, (b) take options, for a defined period of time, to specified targets and (c) upon exercise of those options, secure or “take” licenses to develop and commercialize products for the specified targets on established terms. Under these agreements, fees may be due to the Company (i) at the inception of the arrangement (referred to as “upfront” fees or payments), (ii) upon taking an option with respect to a specific target (referred to as option fees or payments earned, if any, when the option is “taken”), (iii) upon the exercise of a previously taken option to acquire a development and commercialization license(s) (referred to as exercise fees or payments earned, if any, when the development and commercialization license is “taken”), or (iv) some combination of all of these fees. The accounting for right to test agreements is dependent on the nature of the options granted to the collaborative partner. Options are considered substantive if, at the inception of a right to test agreement, the Company is at risk as to whether the collaborative partner will choose to exercise the options to secure development and commercialization licenses. Factors that are considered in evaluating whether options are substantive include the overall objective of the arrangement, the benefit the collaborator might obtain from the agreement without exercising the options, the cost to exercise the options relative to the total upfront consideration, and the additional financial commitments or economic penalties imposed on the collaborator as a result of exercising the options. None of the Company’s right to test agreements entered into subsequent to the adoption of Accounting Standards Update, or ASU, No. 2009 13, “Revenue Arrangements with Multiple Deliverables” on July 1, 2010 has been determined to contain substantive options. For right to test agreements where the options to secure development and commercialization licenses to the Company’s ADC technology are not considered substantive, the Company considers the development and commercialization licenses to be a deliverable at the inception of the agreement and applies the multiple element revenue recognition criteria to determine the appropriate revenue recognition. Subsequent to the adoption of ASU No. 2009-13, the Company determined that its research licenses lack stand-alone value and are considered for aggregation with the other elements of the arrangement and accounted for as one unit of accounting. The Company does not directly control when or if any collaborator will exercise its options for development and commercialization licenses. As a result, the Company cannot predict when or if it will recognize revenues in connection with any of the foregoing. Inventory Inventory costs relate to clinical trial materials being manufactured for sale to the Company’s collaborators. Inventory is stated at the lower of cost or market as determined on a first ‑in, first ‑out (FIFO) basis. Inventory at June 30, 2016 and 2015 is summarized below (in thousands): June 30, 2016 2015 Raw materials $ $ Work in process Total $ $ Raw materials inventory consists entirely of proprietary cell ‑killing agents the Company developed as part of its ADC technology. All raw materials inventory is currently procured from two suppliers. Work in process inventory consists of conjugate manufactured for sale to the Company’s collaborators to be used in preclinical and clinical studies. All conjugate is made to order at the request of the collaborators and subject to the terms and conditions of respective supply agreements. As such, no excess reserve for work in process inventory is required. As discussed above, the Company’s costs to manufacture conjugate on behalf of its partners are greater than the supply prices charged to partners, and therefore costs are capitalized into inventory at the supply prices. Raw materials inventory cost is stated net of write ‑downs of $1.4 million as of June 30, 2016 and June 30, 2015. The write ‑downs represent the cost of raw materials that the Company considers to be in excess of a twelve ‑month supply based on firm, fixed orders and projections from its collaborators as of the respective balance sheet date. Due to yield fluctuations, the actual amount of raw materials that will be produced in future periods under third ‑party supply agreements is highly uncertain. As such, the amount of raw materials produced could be more than is required to support the development of the Company’s collaborators’ product candidates. Such excess supply, as determined under the Company’s inventory reserve policy, is charged to research and development expense. The Company produces preclinical and clinical materials for its collaborators either in anticipation of or in support of preclinical studies and clinical trials, or for process development and analytical purposes. Under the terms of supply agreements with its collaborators, the Company generally receives rolling six ‑month firm, fixed orders for conjugate that the Company is required to manufacture, and rolling twelve ‑month manufacturing projections for the quantity of conjugate the collaborator expects to need in any given twelve ‑month period. The amount of clinical material produced is directly related to the number of collaborator anticipated or on ‑going clinical trials for which the Company is producing clinical material, the speed of enrollment in those trials, the dosage schedule of each clinical trial and the time period, if any, during which patients in the trial receive clinical benefit from the clinical materials. Because these elements are difficult to estimate over the course of a trial, substantial differences between collaborators’ actual manufacturing orders and their projections could result in the Company’s usage of raw materials varying significantly from estimated usage at an earlier reporting period. To the extent that a collaborator has provided the Company with a firm, fixed order, the collaborator is required by contract to reimburse the Company the full negotiated price of the conjugate, even if the collaborator subsequently cancels the manufacturing run. The Company capitalizes raw material as inventory upon receipt and accounts for the raw material inventory as follows: a) to the extent that the Company has up to twelve months of firm, fixed orders and/or projections from its collaborators, the Company capitalizes the value of raw materials that will be used in the production of conjugate subject to these firm, fixed orders and/or projections; b) the Company considers more than a twelve month supply of raw materials that is not supported by firm, fixed orders and/or projections from its collaborators to be excess and establishes a reserve to reduce to zero the value of any such excess raw material inventory with a corresponding charge to research and development expense; and c) the Company also considers any other external factors and information of which it becomes aware and assesses the impact of such factors or information on the net realizable value of the raw material inventory at each reporting period. During fiscal years 2016, 2015 and 2014, the Company obtained additional amounts of its cell-killing agents DMx from its supplier which yielded more material than would be required by the Company’s collaborators over the next twelve months, and as a result, the Company recorded $1.1 million, $1.0 million and $364,000 ,respectively, of charges to research and development expense related to raw material inventory identified as excess. Increases in the Company’s on ‑hand supply of raw materials, or a reduction to the Company’s collaborators’ projections, could result in significant changes in the Company’s estimate of the net realizable value of such raw material inventory. Reductions in collaborators’ projections could indicate that the Company has excess raw material inventory and the Company would then evaluate the need to record write ‑downs as charges to research and development expense. Unbilled Revenue The majority of the Company’s unbilled revenue at June 30, 2016 and 2015 represents research funding earned based on actual resources utilized under the Company’s various collaborator agreements. Other Accrued Liabilities Other accrued liabilities consisted of the following at June 30, 2016 and 2015 (in thousands): June 30, 2016 2015 Accrued contract payments $ $ Accrued clinical trial costs Accrued professional services Accrued employee benefits Accrued public reporting charges Other current accrued liabilities Total $ $ Research and Development Expenses The Company’s research and development expenses are charged to expense as incurred and relate to (i) research to evaluate new targets and to develop and evaluate new antibodies, linkers and cytotoxic agents, (ii) preclinical testing of its own and, in certain instances, its collaborators’ product candidates, and the cost of its own clinical trials, (iii) development related to clinical and commercial manufacturing processes and (iv) manufacturing operations which also include raw materials. Payments made by the Company in advance for research and development services not yet provided and/or materials not yet delivered and accepted are recorded as prepaid expenses and are included in the accompanying Consolidated Balance Sheets as prepaid and other current assets. Income Taxes The Company uses the liability method to account for income taxes. Deferred tax assets and liabilities are determined based on differences between the financial reporting and income tax basis of assets and liabilities, as well as net operating loss carry forwards and tax credits and are measured using the enacted tax rates and laws that will be in effect when the differences reverse. A valuation allowance against net deferred tax assets is recorded if, based on the available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. Financial Instruments and Concentration of Credit Risk Cash and cash equivalents are primarily maintained with three financial institutions in the U.S. Deposits with banks may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk. The Company’s cash equivalents consist of money market funds with underlying investments primarily being U.S. Government ‑ issued securities and high quality, short ‑term commercial paper. Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and marketable securities. The Company held no marketable securities as of June 30, 2016. The Company’s investment policy, approved by the Board of Directors, limits the amount it may invest in any one type of investment, thereby reducing credit risk concentrations. Cash and Cash Equivalents All highly liquid financial instruments with maturities of three months or less when purchased are considered cash equivalents. As of June 30, 2016 and June 30, 2015, the Company held $245.0 million and $ 278.1 million, respectively, in cash and money market funds consisting principally of U.S. Government-issued securities and high quality, short-term commercial paper which were classified as cash and cash equivalents. Non-cash Investing Activities The Company had $804,000 of accrued capital expenditures as of June 30, 2016 which have been treated as a non-cash investing activity and, accordingly, are not reflected in the consolidated statement of cash flows. Accrued capital expenditures as of June 30, 2015 were not material and are included in the consolidated statement of cash flows. Fair Value of Financial Instruments ASC Topic 820 defines fair value, establishes a framework for measuring fair value in accordance with accounting principles generally accepted in the U.S., and expands disclosures about fair value measurements. Fair value is defined under ASC Topic 820 as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value hierarchy to measure fair value which is based on three levels of inputs, of which the first two are considered observable and the last unobservable, as follows: · Level 1—Quoted prices in active markets for identical assets or liabilities. · Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. · Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. As of June 30, 2016, the Company held certain assets that are required to be measured at fair value on a recurring basis. The following table represents the fair value hierarchy for the Company’s financial assets measured at fair value on a recurring basis as of June 30, 2016 (in thousands): Fair Value Measurements at June 30, 2016 Using Quoted Prices in Significant Active Markets for Significant Other Unobservable Identical Assets Observable Inputs Inputs Total (Level 1) (Level 2) (Level 3) Cash equivalents $ $ $ — $ — As of June 30, 2015, the Company held certain assets that are required to be measured at fair value on a recurring basis. The following table represents the fair value hierarchy for the Company’s financial assets measured at fair value on a recurring basis as of June 30, 2015 (in thousands): Fair Value Measurements at June 30, 2015 Using Quoted Prices in Significant Active Markets for Significant Other Unobservable Identical Assets Observable Inputs Inputs Total (Level 1) (Level 2) (Level 3) Cash equivalents $ $ $ — $ — The fair value of the Company’s cash equivalents is based primarily on quoted prices from active markets. The carrying amounts reflected in the consolidated balance sheets for accounts receivable, unbilled revenue, prepaid and other current assets, accounts payable, accrued compensation, and other accrued liabilities approximate fair value due to their short ‑term nature. The carrying amount and estimated fair value of the convertible 4.5% senior notes was $100.0 million and $91.2 million, respectively, as of June 30, 2016. The fair value of the Convertible Notes is influenced by interest rates, the Company’s stock price and stock price volatility and is determined by prices for the Convertible Notes observed in a market which is a Level 2 input for fair value purposes. Property and Equipment Property and equipment are stated at cost. The Company provides for depreciation based upon expected useful lives using the straight ‑line method over the following estimated useful lives: Machinery and equipment 5 years Computer hardware and software 3 years Furniture and fixtures 5 years Leasehold improvements Shorter of remaining lease term or 7 years Equipment under capital leases is amortized over the lives of the respective leases or the estimated useful lives of the assets, whichever is shorter, and included in depreciation expense. Maintenance and repairs are charged to expense as incurred. Upon retirement or sale, the cost of disposed assets and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the statement of operations. The Company recorded $ 21,000 , $(7,000) and $(20,000 ) of gains (losses) on the sale/disposal of certain furniture and equipment during the years ended June 30, 2016, 2015, and 2014, respectively. Impairment of Long ‑Lived Assets In accordance with ASC Topic 360, “Property, Plant, and Equipment,” the Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its long ‑lived assets may warrant revision or that the carrying value of these assets may be impaired if impairment indicators are present. The Company evaluates the realizability of its long ‑lived assets based on cash flow expectations for the related asset. Any write ‑downs to fair value are treated as permanent reductions in the carrying amount of the assets. Based on this evaluation, the Company believes that, as of each of the balance sheet dates presented, none of the Company’s long ‑lived assets were impaired. Compu |
Agreements
Agreements | 12 Months Ended |
Jun. 30, 2016 | |
Agreements | |
Agreements | C. Agreements Significant Collaborative Agreements Roche In 2000, the Company granted Genentech, now a unit of Roche, an exclusive license to use the Company’s maytansinoid ADC technology with antibodies, such as trastuzumab, or other proteins that target HER2. Under the terms of this agreement, Roche has exclusive worldwide rights to develop and commercialize maytansinoid ADC compounds targeting HER2. In 2013, the HER2 ‑targeting ADC compound, Kadcyla, was approved for marketing in the U.S., Japan and the European Union, or EU. Roche has also received marketing approval in various other countries around the world. Roche is responsible for the manufacturing, product development and marketing of any products resulting from the agreement. The Company is compensated for any preclinical and clinical materials that the Company manufactures under the agreement. The Company received a $2 million non ‑refundable upfront payment from Roche upon execution of the agreement. The Company is also entitled to receive up to a total of $44 million in milestone payments, plus royalties on the commercial sales of Kadcyla or any other resulting products. Total milestones are categorized as follows: development milestones— $13.5 million; and regulatory milestones— $30.5 million. Through June 30, 2016, the Company has received and recognized $13.5 million and $20.5 million in development and regulatory milestone payments, respectively, related to Kadcyla. The Company received two $5 million regulatory milestone payments in connection with marketing approval of Kadcyla in Japan and in the EU, which is included in license and milestone fees for the fiscal year ended June 30, 2014 . Based on an evaluation of the effort contributed to the achievement of these milestones in fiscal year 2014, the Company determined these milestones were not substantive. In consideration that there were no undelivered elements remaining, no continuing performance obligations and all other revenue recognition criteria had been met, the Company recognized the non ‑refundable payments as revenue upon achievement of the milestones. The next potential milestone the Company will be entitled to receive will be a $5 million regulatory milestone for marketing approval of Kadcyla for a first extended indication as defined in the agreement. Based on an evaluation of the effort contributed towards the achievement of this future milestone, the Company determined this milestone is not substantive. The Company receives royalty reports and payments related to sales of Kadcyla from Roche one quarter in arrears. In accordance with the Company’s revenue recognition policy, $25.3 million of non-cash royalties on net sales of Kadcyla for the twelve ‑month period ended March 31, 2016 were recorded and included in royalty revenue for the year ended June 30, 2016 and $5.5 million of non-cash royalties and $13.9 million of cash royalties on net sales of Kadcyla for the twelve ‑month period ended March 31, 2015 is included in royalty revenue for the year ended June 30, 2015. The Company recorded $10.3 million of cash royalties on net sales of Kadcyla for the twelve ‑month period ended March 31, 2014 for the year ended June 30, 2014. Kadcyla sales occurring after January 1, 2015 are covered by a royalty purchase agreement whereby the associated cash is remitted to Immunity Royalty Holdings, L.P, or IRH, as discussed further in Note F. Roche, through its Genentech unit, also has licenses for the exclusive right to use the Company’s maytansinoid ADC technology with antibodies to four undisclosed targets, which were granted under the terms of a separate, now expired 2000 right ‑to ‑test agreement with Genentech. For each of these licenses the Company received a $1 million license fee and is entitled to receive up to a total of $38 million in milestone payments and also royalties on the sales of any resulting products. The total milestones are categorized as follows: development milestones— $8 million; regulatory milestones— $20 million; and sales milestones— $10 million. The Company has not received any milestone payments from these agreements through June 30, 2016. Roche is responsible for the development, manufacturing, and marketing of any products resulting from these licenses. The next potential milestone the Company will be entitled to receive under any of these agreements will be a development milestone for filing of an IND application which will result in a $1 million payment being due. At the time of execution of each of these development and commercialization licenses, there was significant uncertainty as to whether this milestone would be achieved. In consideration of this, as well as the Company’s past involvement in the research and manufacturing these products, this milestone was deemed substantive. The Company received non ‑refundable technology access fees totaling $5 million for the eight ‑year term of the right ‑to ‑test agreement. The upfront fees were deferred and recognized ratably over the period during which Genentech could elect to obtain product licenses. Amgen Under a now ‑expired right ‑to ‑test agreement established in 2000, Amgen took three exclusive development and commercialization licenses, for which the Company received an exercise fee of $1 million for each license taken. In May 2013, Amgen took one non ‑exclusive development and commercialization license, for which the Company received an exercise fee of $500,000 . In October 2013, the non ‑exclusive license was amended and converted to an exclusive license, for which Amgen paid an additional $500,000 fee to the Company. Amgen has sublicensed its rights under this license to Oxford BioTherapeutics Ltd. In December 2015, Amgen advised the Company that it had discontinued development of two product candidates, AMG 595 and AMG 172 that had been covered by two of Amgen’s four exclusive licenses, and in February 2016, Amgen terminated these two licenses. For each of the two remaining development and commercialization license taken, the Company is entitled to receive up to a total of $34 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones per license are categorized as follows: development milestones— $9 million; regulatory milestones— $20 million; and sales milestones— $5 million. Amgen (or its sublicensee(s)) is responsible for the manufacturing, product development and marketing of any products resulting from these development and commercialization licenses. Through June 30, 2016, the Company has received and recognized an aggregate of $3 million in milestone payments for compounds covered under this agreement now or in the past. In September 2015, Amgen’s IND application under the remaining license not sublicensed to Oxford BioTherapeutics became effective, triggering a $1 million milestone payment to the Company which is included in license and milestone fee revenue for the year ended June 30, 2016. The next potential milestone the Company will be entitled to receive under this license will be a development milestone for the first dosing of a patient in a Phase II clinical trial, which will result in a $3 million payment being due. The next potential milestone the Company will be entitled to receive under the May 2013 license will be a $1 million development milestone for an IND becoming effective. At the time of execution of each of these development and commercialization licenses, there was significant uncertainty as to whether these milestones would be achieved. In consideration of this, as well as the Company’s past involvement in the research and manufacturing of these product candidates, these milestones were deemed substantive. Since a deliverable to the original right ‑to ‑test agreement was determined to be materially modified at the time the non ‑exclusive license was converted to exclusive in October 2013, the Company accounted for the multiple ‑element agreement in accordance with ACS 605 ‑25 (as amended by ASU No. 2009 ‑13). As a result, all of the deferred revenue recorded on the date of the modification and the new consideration received as part of the modification was allocated to all of the remaining deliverables at the time of amendment of the right ‑to ‑test agreement based on the estimated selling price of each element. The remaining amount represents consideration for previously delivered elements and was recognized upon the execution of the modification. The outstanding licenses, including the exclusive license delivered upon the signing of the amendment, contain the rights to future technological improvements as well as options to purchase materials and research and development services. The Company concluded that additional materials and research and development services would be paid at a contractual price equal to the estimated selling price based estimated prices that would be charged by third parties for similar services. The estimated selling price of the right to technological improvements is the Company’s best estimate of selling price and was determined by estimating the probability that technological improvements will be made and the probability that such technological improvements made will be used by Amgen. In estimating these probabilities, we considered factors such as the technology that is the subject of the development and commercialization licenses, our history of making technological improvements, and when such improvements, if any, were likely to occur relative to the stage of development of any product candidates pursuant to the development and commercialization licenses. The Company’s estimate of probability considered the likely period of time that any improvements would be utilized, which was estimated to be ten years following delivery of a commercialization and development license. The value of any technological improvements made available after this ten year period was considered to be de minimis due to the significant additional costs that would be incurred to incorporate such technology into any existing product candidates. The estimate of probability was multiplied by the estimated selling price of the development and commercialization licenses and the resulting cash flow was discounted at a rate of 13% , representing the Company’s estimate of its cost of capital at the time of amendment of the right ‑to ‑test agreement. The $430,000 determined to be the estimated selling price of the future technological improvements is being recognized as revenue ratably over the period the Company is obligated to make available any technological improvements, which is equivalent to the estimated term of the agreement. The Company estimates the term of a development and commercialization license to be approximately 25 years, which reflects management’s estimate of the time necessary to develop and commercialize products pursuant to the license plus the estimated royalty term. The Company reassesses the estimated term at the end of each reporting period. After accounting for the undelivered elements at the estimated selling price, the Company had $2.2 million of remaining allocable consideration which was determined to represent consideration for the previously delivered elements, including the exclusive license that was delivered upon the execution of the modification. This amount was recorded as revenue and is included in license and milestone fees for the year ended June 30, 2014. Costs directly attributable to the Amgen collaborative agreement are comprised of compensation and benefits related to employees who provided research and development services on behalf of Amgen as well as costs of clinical materials sold. Indirect costs are not identified to individual collaborators. The costs related to the research and development services amounted to approximately $15,000 , $62,000 and $179,000 for fiscal years 2016, 2015 and 2014, respectively. The costs related to clinical materials sold were approximately $664,000 for fiscal year 2014. There were no similar costs recorded in fiscal years 2016 and 2015. Sanofi Collaboration Agreement In 2003, the Company entered into a broad collaboration agreement with Sanofi (formerly Aventis) to discover, develop and commercialize antibody ‑based products. The collaboration agreement provides Sanofi with worldwide development and commercialization rights to new antibody ‑based products directed to targets that are included in the collaboration, including the exclusive right to use the Company’s maytansinoid ADC technology in the creation of products developed to these targets. The product candidates (targets) as of June 30, 2016 in the collaboration include isatuximab (CD38), SAR566658 (CA6), SAR408701 (CEACAM5) and one earlier ‑stage program that has yet to be disclosed. The Company is entitled to receive milestone payments potentially totaling $21.5 million, per target, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones— $7.5 million; and regulatory milestones— $14 million. Through June 30, 2016, the Company has received and recognized an aggregate of $20.5 million in milestone payments for compounds covered under this agreement now or in the past, including a $3 million development milestone related to initiation of a Phase IIb clinical trial (as defined in the agreement) for isatuximab and a $1 million development milestone related to initiation of a Phase I clinical trial for SAR408701 which are included in license and milestone fee revenue for the year ended June 30, 2015. The next potential milestone the Company will be entitled to receive for each of SAR566658 and SAR408701 will be a development milestone for initiation of a Phase IIb clinical trial (as defined in the agreement), which will result in each case in a $3 million payment being due. The next potential milestone the Company will be entitled to receive with respect to isatuximab will be a development milestone for initiation of a Phase III clinical trial, which will result in a $3 million payment being due. The next potential milestone the Company will be entitled to receive for the unidentified target will be a development milestone for commencement of a Phase I clinical trial, which will result in a $1 million payment being due. At the time of execution of this agreement, there was significant uncertainty as to whether these milestones would be achieved. In consideration of this, as well as the Company’s past involvement in the research and manufacturing of these product candidates, these milestones were deemed substantive. Right-to-Test Agreement Under a separate, now expired right-to-test agreement, in December 2013, Sanofi took one exclusive development and commercialization license. Under this license, the Company received an exercise fee of $2 million and was recognizing this amount as revenue ratably over the Company’s estimated period of its substantial involvement. The Company had previously estimated this development period would conclude at the end of non-pivotal Phase II testing. During fiscal 2015, the Company determined it would not be substantially involved in the development and commercialization of the product based on Sanofi’s current plans to develop and manufacture the product without the assistance of the Company. As a result of this determination, the Company recognized the balance of the upfront exercise fee during the first quarter of fiscal 2015. This change in estimate resulted in an increase to license and milestone fees of $1.5 million for the year ended June 30, 2015 compared to amounts that would have been recognized pursuant to the Company’s previous estimate. Under this license, the Company is entitled to receive up to a total of $30 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones— $10 million; and regulatory milestones— $20 million. In October 2015, Sanofi initiated Phase I, first-in-human clinical testing of its ADC product candidate, SAR428926 (LAMP1), triggering a $2 million development milestone payment to the Company which is included in license and milestone fee revenue for the year ended June 30, 2016. The next milestone payment the Company could receive would be a $4 million development milestone for commencement of a Phase IIb clinical trial (as defined in the agreement) under this license. At the time of execution of this agreement, there was significant uncertainty as to whether these milestones would be achieved. In consideration of this, as well as the Company’s expected involvement in the research and manufacturing of this product candidate, these milestones were deemed substantive. Sanofi is responsible for the manufacturing, product development and marketing of any products resulting from the agreement. Biotest In 2006, the Company granted Biotest an exclusive development and commercialization license to our maytansinoid ADC technology for use with antibodies that target CD138. The product candidate indatuximab ravtansine is in development under this agreement. Biotest is responsible for the manufacturing, product development and marketing of any products resulting from the agreement. The Company received a $1 million upfront payment upon execution of the agreement and could receive up to $35.5 million in milestone payments, as well as royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones— $4.5 million; and regulatory milestones— $31 million. The Company receives payments for manufacturing any preclinical and clinical materials made at the request of Biotest. In September 2008, Biotest began Phase I evaluation of indatuximab ravtansine which triggered a $500,000 milestone payment to the Company. The next potential milestone the Company will be entitled to receive will be a development milestone for commencement of a Phase IIb clinical trial (as defined in the agreement) which will result in a $2 million payment being due. At the time of execution of this agreement, there was significant uncertainty as to whether these milestones would be achieved. In consideration of this, as well as the Company’s past involvement in the research and manufacturing of this product, these milestones were deemed substantive. The agreement also provided the Company with the right to elect at specific stages during the clinical evaluation of any compound created under this agreement, to participate in the U.S. development and commercialization of that compound in lieu of receiving the milestone payments not yet earned and royalties on sales in the U.S. Currently, the Company can exercise this right during an exercise period specified in the agreement by notice and payment to Biotest of an agreed upon opt ‑in fee of $15 million. Upon exercise of this right, the Company would share equally with Biotest the associated further costs of product development and commercialization in the U.S. along with the profit, if any, from product sales in the U.S. The Company would also be entitled to receive royalties, on a reduced basis, on product sales outside the U.S. Costs directly attributable to the Biotest collaborative agreement are comprised of compensation and benefits related to employees who provided research and development services on behalf of Biotest as well as costs of clinical materials sold. Indirect costs are not identified to individual collaborators. The costs related to the research and development services amounted to approximately $160,000 , $309,000 and $305,000 for fiscal years 2016, 2015 and 2014, respectively. The costs related to clinical materials sold were approximately $1. 8 million, $3 million and $670,000 for fiscal years 2016, 2015 and 2014, respectively. Bayer In 2008, the Company granted Bayer an exclusive development and commercialization license to the Company’s maytansinoid ADC technology for use with antibodies or other proteins that target mesothelin. Bayer HealthCare is responsible for the research, development, manufacturing and marketing of any products resulting from the license. The Company received a $4 million upfront payment upon execution of the agreement, and—for each compound developed and marketed by Bayer under this collaboration—the Company is entitled to receive a total of $170.5 million in milestone payments, plus tiered royalties between 4 - 7% on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones— $16 million; regulatory milestones— $44.5 million; and sales milestones— $110 million. Through June 30, 2016, the Company has received and recognized an aggregate of $13 million in milestone payments under this agreement. In January 2016, Bayer initiated a Phase II clinical study designed to support registration of its ADC product candidate, anetumab ravtansine, triggering a $10 million development milestone payment to the Company which is included in license and milestone fee revenue for the year ended June 30, 2016. The next potential milestone the Company will be entitled to receive will be either a development milestone for commencement of a pivotal clinical trial for a second indication for anetumab ravtansine which will result in a $2 million payment being due or a regulatory milestone for filing of regulatory approval for its first indication for anetumab ravtansine which will result in a $6 million payment being due. At the time of execution of this agreement, there was significant uncertainty as to whether these milestones would be achieved. In consideration of this, as well as the Company’s past involvement in the research and supply of cytotoxic agent for this product candidate, these milestones was deemed substantive. The Company had previously deferred the $4 million upfront payment received and was recognizing this amount as revenue ratably over the estimated period of substantial involvement. The Company had previously estimated this development period would conclude at the end of non ‑pivotal Phase II testing. During the first quarter of fiscal 2012, Bayer initiated Phase I clinical testing of its product candidate. In reaching this stage of clinical testing, Bayer developed its own processes for manufacturing required clinical material and produced clinical material in its own manufacturing facility. Considering that Bayer was able to accomplish this without significant reliance on the Company, and considering that the Company’s expected future involvement would be primarily supplying Bayer with small quantities of cytotoxic agents for a limited period of time, the Company believed its period of substantial involvement would end prior to the completion of non ‑pivotal Phase II testing. As a result of this determination, beginning in September 2011, the Company recognized the balance of the upfront payment as revenue ratably through September 2012. Novartis Novartis took six exclusive development and commercialization licenses under a now-expired right-to-test agreement established in 2010. The Company received a $45 million upfront payment in connection with the execution of the right ‑to ‑test agreement in 2010, and for each development and commercialization license taken for a specific target, the Company received an exercise fee of $1 million and is entitled to receive up to a total of $199.5 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones— $22.5 million; regulatory milestones— $77 million; and sales milestones— $100 million. The initial three -year term of the right-to-test agreement was extended by Novartis in October 2013 for an additional one -year period by payment of a $5 million fee to the Company. The Company also is entitled to receive payments for research and development activities performed on behalf of Novartis. Novartis is responsible for the manufacturing, product development and marketing of any products resulting from this agreement. In March 2013, the Company and Novartis amended the right ‑to ‑test agreement so that Novartis could take a license to develop and commercialize products directed at two undisclosed, related targets, one target licensed on an exclusive basis and the other target initially licensed on a non ‑exclusive basis. The target licensed on a non ‑exclusive basis may no longer be converted to an exclusive target due to the expiration of the right-to-test agreement. The Company received a $ 3.5 million fee in connection with the execution of the amendment to the agreement. The Company may be required to credit this fee against future milestone payments if Novartis discontinues the development of a specified product under certain circumstances. In connection with the amendment, in March 2013, Novartis took the license referenced above under the right ‑to ‑test agreement, as amended, enabling it to develop and commercialize products directed at the two targets. The Company received a $1 million upfront fee with the execution of this license. Additionally, the execution of this license provides the Company the opportunity to receive milestone payments totaling $199.5 million (development milestones— $22.5 million; regulatory milestones— $77 million; and sales milestones— $100 million) or $238 million (development milestones— $22.5 million; regulatory milestones— $115.5 million; and sales milestones— $100 million), depending on the composition of any resulting products. In October 2013 and November 2013, Novartis took its second and third exclusive licenses to single targets, and in October 2014, took three remaining exclusive licenses, each triggering a $1 million payment to the Company and the opportunity to receive milestone payments totaling $199.5 million, as outlined above, plus royalties on the commercial sales of any resulting products. In January 2015 and May 2015, Novartis initiated Phase I, first-in-human clinical testing of its cKit-targeting ADC product candidate, LOP628, and P-cadherin-targeting ADC product candidate, PCA062 , respectively, triggering a $5 million development milestone payment to the Company with each event, both of which are included in license and milestone fee revenue for the year ended June 30, 2015. The next payment the Company could receive would be either a $7.5 million development milestone for commencement of a Phase II clinical trial under these two licenses or a $5 million development milestone for commencement of a Phase I clinical trial under any of its other four licenses. At the time of execution of these agreements, there was significant uncertainty as to whether these milestones would be achieved. In consideration of this, as well as the Company’s past involvement in the research and manufacturing of these product candidates, these milestones were deemed substantive. Additionally, the Company is entitled to receive royalties on product sales, if any. In accordance with ACS 605 ‑25 (as amended by ASU No. 2009 ‑13), the Company identified all of the deliverables at the inception of the right ‑to ‑test agreement and subsequently when amended. The significant deliverables were determined to be the right ‑to ‑test, or research, license, the development and commercialization licenses, rights to future technological improvements, and the research services. The options to obtain development and commercialization licenses in the right ‑to ‑test agreement were determined not to be substantive and, as a result, the exclusive development and commercialization licenses were considered deliverables at the inception of the right ‑to ‑test agreement. Factors that were considered in determining the options were not substantive included (i) the overall objective of the agreement was for Novartis to obtain development and commercialization licenses, (ii) the size of the exercise fee of $1 million for each development and commercialization license obtained is not significant relative to the $45 million upfront payment that was due at the inception of the right ‑to ‑test agreement, (iii) the limited economic benefit that Novartis could obtain from the right ‑to ‑test agreement unless it exercised its options to obtain development and commercialization licenses, and (iv) the lack of economic penalties as a result of exercising the options. The Company has determined that the research license together with the development and commercialization licenses represent one unit of accounting as the research license does not have stand ‑alone value from the development and commercialization licenses due to the lack of transferability of the research license and the limited economic benefit Novartis would derive if they did not obtain any development and commercialization licenses. The Company has also determined that this unit of accounting does have stand ‑alone value from the rights to future technological improvements and the research services. The rights to future technological improvements and the research services are considered separate units of accounting as each of these was determined to have stand ‑alone value. The rights to future technological improvements have stand ‑alone value as Novartis would be able to use those items for their intended purpose without the undelivered elements. The research services have stand ‑alone value as similar services are sold separately by other vendors. The estimated selling prices for the development and commercialization licenses are the Company’s best estimate of selling price and were determined based on market conditions, similar arrangements entered into by third parties, including the Company’s understanding of pricing terms offered by its competitors for single-target development and commercialization licenses that utilize ADC technology, and entity-specific factors such as the pricing terms of the Company’s previous single ‑target development and commercialization licenses, recent preclinical and clinical testing results of therapeutic products that use the Company’s ADC technology, and the Company’s pricing practices and pricing objectives. The estimated selling price of the right to technological improvements is the Company’s best estimate of selling price and was determined by estimating the probability that technological improvements will be made and the probability that such technological improvements made will be used by Novartis. In estimating these probabilities, we considered factors such as the technology that is the subject of the development and commercialization licenses, our history of making technological improvements, and when such improvements, if any, were likely to occur relative to the stage of development of any product candidates pursuant to the development and commercialization licenses. The Company’s estimate of probability considered the likely period of time that any improvements would be utilized, which was estimated to be ten years following delivery of a commercialization and development license. The value of any technological improvements made available after this ten year period was considered to be de minimis due to the significant additional costs that would be incurred to incorporate such technology into any existing product candidates. The estimate of probability was multiplied by the estimated selling price of the development and commercialization licenses and the resulting cash flow was discounted at a rate of 16% , representing the Company’s estimate of its cost of capital at the time. The estimated selling price of the research services was based on third ‑party evidence given the nature of the research services to be performed for Novartis and market rates for similar services. Upon payment of the extension fee in October 2013, the total arrangement consideration of $60.2 million (which comprises the $45 million upfront payment, the amendment fee of $ 3.5 million, the $5 million extension fee, the exercise fee for each license, and the expected fees for the research services to be provided under the remainder of the arrangement) was reallocated to the deliverables based on the relative selling price method as follows: $55 million to the delivered and undelivered development and commercialization licenses; $4.5 million to the rights to future technological improvements; and $710,000 to the research services. The Company recorded $25.7 million of the $ 55 million of the arrangement consideration outlined above for the three |
Property and Equipment
Property and Equipment | 12 Months Ended |
Jun. 30, 2016 | |
Property and Equipment | |
Property and Equipment | D. Property and Equipment Property and equipment consisted of the following at June 30, 2016 and 2015 (in thousands): June 30, 2016 2015 Leasehold improvements $ $ Machinery and equipment Computer hardware and software Furniture and fixtures Assets under construction $ $ Less accumulated depreciation Property and equipment, net $ $ Depreciation expense was approximately $5.3 million, $5.5 million and $ 4.6 million for each of the years ended June 30, 2016, 2015 and 2014, respectively. Included in the table above, the Company’s investment in equipment under capital leases was $876,000 , net of accumulated amortization of $414,000 , at June 30, 2016 and $724,000 , net of accumulated amortization of $190,000 , at June 30, 2015. |
Convertible 4.5% Senior Notes
Convertible 4.5% Senior Notes | 12 Months Ended |
Jun. 30, 2016 | |
Convertible 4.5% Senior Notes | |
Convertible 4.5% Senior Notes | E. Convertible 4.5% Senior Notes In June 2016, the Company issued Convertible 4.5% Senior Notes with an aggregate principal amount of $100 million. The Company received net proceeds of approximately $96.6 million from the sale of the Convertible Notes, after deducting fees and expenses of approximately $3.4 million. The Convertible Notes are governed by the terms of an indenture between the Company, as issuer, and Wilmington Trust, National Association, as the trustee. The Convertible Notes are senior unsecured obligations and bear interest at a rate of 4.5% per year, payable semi-annually in arrears on January 1 and July 1 of each year, commencing on January 1, 2017. The Company recorded approximately $138,000 of interest expense for the year ended June 30, 2016 which is included in other (expense) income, net in the consolidated statements of operations. The Convertible Notes will mature on July 1, 2021, unless earlier repurchased or converted. Holders may convert their notes at their option at any time prior to the close of business on the business day immediately preceding the stated maturity date. Upon conversion, the Company will deliver for each $1,000 principal amount of converted notes a number of shares equally to the conversion rate, which will initially be 238.7775 shares of common stock, equivalent to an initial conversion price of approximately $4.19 . The conversion rate will be subject to adjustment in some circumstances, but will not be adjusted for any accrued and unpaid interest. In addition, if a “make-whole fundamental change” (as defined in the offering memorandum) occurs prior to the stated maturity date, the Company will increase the conversion rate for a holder who elects to convert its notes in connection with such make-whole fundamental change in certain circumstances. If the Company undergoes a fundamental change, subject to certain conditions, holders may require the Company to repurchase for cash all or part of their notes at a purchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change purchase date. In addition, upon an event of default, the holders may require the Company to repurchase for cash all of their notes at a purchase price equal to 100% of the principal amount, plus accrued and unpaid interest. Upon bankruptcy, this becomes an automatic repurchase obligation. Also, if the Company fails to comply with certain reporting requirements as described in the indenture it will constitute an event of default, however the Company may elect to pay additional interest at an annual rate equal to 0.5% of the principal amount for the 90 days following such event as a remedy for the default. Subsequent to the 90 days, if still in default, the principal amount of the notes and accrued interest may become immediately due and payable. If a “restricted event” occurs as described in the indenture that causes the notes not to become freely tradable by holders other than our affiliates after the first anniversary of the original issuance date of the notes, the Company would also become obligated to pay additional interest at an annual rate equal to 0.5% of the principal amount. The combined additional interest rate under these two circumstances, however, cannot exceed 0.5% . The Company analyzed the terms of the Convertible Notes and determined that under current accounting guidance the notes would be entirely accounted for as debt and none of the terms of the notes require separate accounting. As part of the issuance of the Convertible Notes, the Company incurred $3.4 million of transaction costs, which are capitalized in the accompanying consolidated balance sheet as deferred financing costs and will be amortized to interest expense ratably over the term of the Convertible Notes. |
Liability Related to Sale of Fu
Liability Related to Sale of Future Royalties | 12 Months Ended |
Jun. 30, 2016 | |
Liability Related to Sale of Future Royalties | |
Liability Related to Sale of Future Royalties | F. Liability Related to Sale of Future Royalties In April 2015, IRH purchased the right to receive 100% of the royalty payments on commercial sales of Kadcyla arising under the Company’s development and commercialization license with Genentech, until IRH has received aggregate royalties equal to $235 million or $260 million, depending on when the aggregate royalties received by IRH reach a specified milestone. Once the applicable threshold is met, if ever, the Company will thereafter receive 85% and IRH will receive 15% of the Kadcyla royalties for the remaining royalty term. At consummation of the transaction in April 2015, the Company received cash proceeds of $200 million. As part of this sale, the Company incurred $5.9 million of transaction costs, which are capitalized in the accompanying consolidated balance sheet as deferred financing costs and will be amortized to interest expense over the estimated life of the royalty purchase agreement. Although the Company sold its rights to receive royalties from the sales of Kadcyla, as a result of its ongoing involvement in the cash flows related to these royalties, the Company will continue to account for these royalties as revenue and recorded the $200 million in proceeds from this transaction as a liability related to sale of future royalties (Royalty Obligation) that will be amortized using the interest method over the estimated life of the royalty purchase agreement. The following table shows the activity within the liability account during the year ended June 30, 2016 (in thousands): Year Period from ended inception to June 30, June 30, 2016 2016 Liability related to sale of future royalties — beginning balance $ $ — Proceeds from sale of future royalties — Non-cash Kadcyla royalty revenue Non-cash interest expense recognized Liability related to sale of future royalties — ending balance $ $ As royalties are remitted to IRH, the balance of the Royalty Obligation will be effectively repaid over the life of the agreement. In order to determine the amortization of the Royalty Obligation, the Company is required to estimate the total amount of future royalty payments to be received and remitted to IRH as noted above over the life of the agreement. The sum of these amounts less the $200 million proceeds the Company received will be recorded as interest expense over the life of the Royalty Obligation. Since inception, the Company’s estimate of this total interest expense resulted in an effective annual interest rate of approximately 9.6% . The Company periodically assesses the estimated royalty payments to IRH and to the extent such payments are greater or less than its initial estimates, or the timing of such payments is materially different than its original estimates, the Company will prospectively adjust the amortization of the Royalty Obligation. There are a number of factors that could materially affect the amount and timing of royalty payments from Genentech, most of which are not within the Company’s control. Such factors include, but are not limited to, changing standards of care, the introduction of competing products, manufacturing or other delays, biosimilar competition, patent protection, adverse events that result in governmental health authority imposed restrictions on the use of the drug products, significant changes in foreign exchange rates as the royalties remitted to IRH are made in U.S. dollars (USD) while significant portions of the underlying sales of Kadcyla are made in currencies other than USD, and other events or circumstances that could result in reduced royalty payments from Kadcyla, all of which would result in a reduction of non-cash royalty revenues and the non-cash interest expense over the life of the Royalty Obligation. Conversely, if sales of Kadcyla are more than expected, the non-cash royalty revenues and the non-cash interest expense recorded by the Company would be greater over the term of the Royalty Obligation. In addition, the royalty purchase agreement grants IRH the right to receive certain reports and other information relating to the royalties and contains other representations and warranties, covenants and indemnification obligations that are customary for a transaction of this nature. |
Income Taxes
Income Taxes | 12 Months Ended |
Jun. 30, 2016 | |
Income Taxes | |
Income Taxes | G. Income Taxes The difference between the Company’s expected tax benefit, as computed by applying the U.S. federal corporate tax rate of 34% to loss before the benefit for income taxes, and actual tax is reconciled in the following chart (in thousands): Year Ended June 30, 2016 2015 2014 Loss before income tax expense $ $ $ Expected tax benefit at 34% $ $ $ Permanent differences Incentive stock options State tax benefit net of federal benefit Increase in valuation allowance, net Federal research credit Federal orphan drug credit — Expired loss and credit carryforwards Other — — Benefit for income taxes $ — $ — $ — At June 30, 2016, the Company has net operating loss, or NOL, carryforwards of approximately $ 377.9 million available to reduce federal taxable income, if any, that expire in 2028 through 2036 and $214.0 million available to reduce state taxable income, if any, that expire in fiscal 2033 through fiscal 2036. Included in the federal and state carryforwards is $27.0 million and $ 20.5 million, respectively, related to deductions from the exercise of stock options and the related tax benefit which will result in an increase in additional paid ‑in capital if and when realized through a reduction of taxes paid in cash. The Company also has federal and state credit carryforwards of approximately $40.4 million available to offset federal and state income taxes, which expire beginning in 2017. Due to the degree of uncertainty related to the ultimate use of the loss carryforwards and tax credits, the Company has established a valuation allowance to fully reserve these tax benefits. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities as of June 30, 2016 and 2015 are as follows (in thousands): June 30, 2016 2015 Deferred tax assets: Net operating loss carryforwards $ $ Research and development tax credit carryforwards Property and other intangible assets Deferred revenue Stock-based compensation Deferred lease incentive Other liabilities Royalty sale Total deferred tax assets $ $ Deferred tax liabilities: Accounting method change Royalty sale transaction costs Total deferred tax liabilities $ $ Valuation allowance Net deferred tax assets/(liabilities) $ — $ — The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. As required by the provisions of ASC 740, the Company has determined that it is not more-likely-than-not that the tax benefits related to the federal and state deferred tax assets will be realized for financial reporting purposes. Accordingly, the deferred tax assets have been fully reserved at June 30, 2016 and 2015. The valuation allowance increased by $ 62.5 million during 2016 due primarily to additional net loss incurred during the year and additional research and development tax credits earned during the year, partially offset by the expiration of net operating loss carryforwards. Utilization of the NOL and credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future as provided by Section 382 of the Internal Revenue Code of 1986, as well as similar state and foreign provisions. These ownership changes may limit the amount of NOL and credit carry forwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50 percentage points over a three ‑year period. Since the Company’s formation, it has raised capital through the issuance of capital stock on several occasions (both pre and post initial public offering) which, combined with the purchasing shareholders’ subsequent disposition of those shares, may have resulted in a change of control, as defined by Section 382, or could result in a change of control in the future upon subsequent disposition. During fiscal year 2015, the Company completed a study to assess whether a change of control has occurred or whether there have been multiple changes of control since its formation and determined no ownership change occurred under Section 382. The study has not been updated for fiscal year 2016. Additionally, the Company has not completed a Research and Development Credit Study; accordingly, it is probable that a portion of the tax credit carryforward may not be available to offset future income. The Company accounts for uncertain tax positions under the recognition and measurement criteria of ASC 740-10. For those tax positions for which it is more likely than not that a tax benefit will be sustained, the Company records the largest amount of tax benefit with a greater than 50% likelihood of being realized upon settlement with a taxing authority that has full knowledge of all relevant information. If the Company does not believe that it is not more likely than not that a tax benefit will be sustained, no tax benefit is recognized. As of June 30, 2016 and 2015, no uncertain tax positions have been recorded. Interest and penalties related to the settlement of uncertain tax positions, if any, will be reflected in income tax expense. The Company did not recognize any interest and penalties associated with unrecognized tax benefits in the accompanying consolidated financial statements. The Company does not expect any material changes to the unrecognized benefits within 12 months of the reporting date. Due to existence of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact our effective tax rate. The statute of limitations for assessment by the Internal Revenue Service, or IRS, and state tax authorities is open for tax years ending June 30, 2013, 2014, 2015 and 2016, although carryforward attributes that were generated prior to fiscal year 2013 may still be adjusted upon examination by the IRS or state tax authorities if they either have been or will be used in a future period. |
Capital Stock
Capital Stock | 12 Months Ended |
Jun. 30, 2016 | |
Capital Stock | |
Capital Stock | H . Capital Stock Common Stock Reserved At June 30, 2016, the Company has reserved 15.5 million shares of authorized common stock for the future issuance of shares under the 2006 Plan and the 2004 Director Plan. See “Stock ‑Based Compensation” in Note B for a description of the 2006 Plan and the Former Plan and below for a description of the 2004 Director Plan. Stock Options As of June 30, 2016, the 2006 Plan was the only employee share ‑based compensation plan of the Company. During the year ended June 30, 2016, holders of options issued under the 2006 Plan and the Former Plan exercised their rights to acquire an aggregate of 555,000 shares of common stock at prices ranging from $3.19 to $17.00 per share. The total proceeds to the Company from these option exercises were approximately $5.2 million. The Company granted options with an exercise price equal to the fair market value of the common stock on the date of such grant. The following options and their respective weighted ‑ average exercise prices per share were exercisable at June 30, 2016, 2015 and 2014: Weighted ‑ Exercisable Average (in thousands) Exercise Price June 30, 2016 $ June 30, 2015 $ June 30, 2014 $ 2001 Non ‑Employee Director Stock Plan In November 2001, the Company’s shareholders approved the establishment of the 2001 Non ‑Employee Director Stock Plan, or the 2001 Director Plan, and 50,000 shares of common stock to be reserved for grant thereunder. The 2001 Director Plan provided for the granting of awards to Non ‑Employee Directors and, at the election of Non ‑Employee Directors, to have all or a portion of their awards in the form of cash, stock, or stock units. All stock or stock units are immediately vested. The number of stock or stock units issued was determined by the market value of the Company’s common stock on the last date of the Company’s fiscal quarter for which the services are rendered. The 2001 Director Plan was administered by the Board of Directors which was authorized to interpret the provisions of the 2001 Director Plan, determine which Non ‑Employee Directors would be granted awards, and determine the number of shares of stock for which a stock right will be granted. The 2001 Director Plan was replaced in 2004 by the 2004 Non ‑Employee Director Compensation and Deferred Share Unit Plan. During the years ended June 30, 2016, 2015 and 2014, the Company recorded approximately $(72,000) , $16,000 , and $(30,000) in (expense reduction) compensation expense, respectively, related to approximately 6,000 stock units outstanding under the 2001 Director Plan. The value of the stock units is adjusted to market value at each reporting period. No stock units have been issued under the 2001 Plan subsequent to June 30, 2004. 2004 Non ‑Employee Director Compensation and Deferred Share Unit Plan In June 2004, the Board of Directors approved the establishment of the 2004 Non ‑Employee Director Compensation and Deferred Share Unit Plan, or the 2004 Director Plan. The 2004 Director Plan provided for the compensation of Non ‑Employee Directors, awarding their annual retainers in the form of deferred share units, and, at their discretion, to have all or a portion of their other compensation such as meeting fees in the form of cash or deferred share units. The deferred share units for annual retainers vested one ‑twelfth monthly over the next year after the award; other deferred share units vested immediately upon issuance. The number of deferred share units issued was determined by the market value of the Company’s common stock on the last date of the Company’s fiscal year prior to the fiscal year for which services were rendered. The deferred share units were to be paid out in cash to each non ‑employee director based upon the market value of the Company’s common stock on the date of such director’s retirement from the Board of Directors of the Company. The 2004 Director Plan was administered by the Board of Directors. The 2004 Director Plan was amended on September 5, 2006. Under the terms of the amended 2004 Director Plan, the redemption amount of deferred share units will be paid in shares of common stock of the Company under the 2006 Plan in lieu of cash. As a result of the change in payout structure, the value of the vested awards was transferred to additional paid ‑in capital as of the modification date and the total value of the awards, as calculated on the modification date, was expensed over the remainder of the vesting period. Accordingly, the value of the share units is fixed and will no longer be adjusted to market value at each reporting period. In addition, the amended 2004 Director Plan changed the vesting for annual retainers to take place quarterly over the three years after the award and the number of deferred share units awarded for all compensation is now based on the market value of the Company’s common stock on the date of the award. Compensation Policy for Non ‑Employee Directors On September 16, 2009, the Board adopted a new Compensation Policy for Non ‑Employee Directors, which superseded the 2004 Plan and made certain changes to the compensation of its non ‑employee directors. The policy was amended on November 11, 2009 to provide that, whenever the Board has a non ‑employee Chairman in lieu of a Lead Director, the cash payment for the non ‑employee Chairman of the Board shall be the same as the cash compensation that would otherwise have been payable to the Lead Director. Effective November 12, 2009, non ‑employee directors became entitled to receive annual meeting fees and committee fees under the new policy. The new policy made changes to the equity portion of the non ‑employee director compensation, but left the cash portion unchanged. Effective November 11, 2009, non ‑employee directors became entitled to receive deferred stock units under the new policy as follows: · New non ‑employee directors will be initially awarded a number of deferred stock units having an aggregate market value of $65,000 , based on the closing price of our common stock on the date of their initial election to the Board. These awards will vest quarterly over three years from the date of grant, contingent upon the individual remaining a director of ImmunoGen as of each vesting date. · On the first anniversary of a non ‑employee director’s initial election to the Board, such non ‑employee director will be awarded a number of deferred stock units having an aggregate market value of $30,000 , based on the closing price of our common stock on such date of grant and pro ‑rated based on the number of whole months remaining between the first day of the month in which such grant date occurs and the first October 31 following the grant date. These awards will generally vest quarterly over approximately the period from the grant date to the first November 1 following the grant date, contingent upon the individual remaining a director of ImmunoGen as of each vesting date. · Thereafter, non ‑employee directors in general will be annually awarded a number of deferred stock units having an aggregate market value of $30,000 , based on the closing price of our common stock on the date of our annual meeting of shareholders. These awards will vest quarterly over approximately one year from the date of grant, contingent upon the individual remaining a director of ImmunoGen as of each vesting date. As with the 2004 Plan, vested deferred stock units are redeemed on the date a director ceases to be a member of the Board, at which time such director’s deferred stock units will be settled in shares of our common stock issued under our 2006 Plan at a rate of one share for each vested deferred stock unit then held. Any deferred stock units that remain unvested at that time will be forfeited. The new policy provides that all unvested deferred stock units will automatically vest immediately prior to the occurrence of a change of control, as defined in the 2006 Plan. Pursuant to the Compensation Policy for Non- Employee Directors, the Company issued a retiring director 43,615 shares of common stock in November 2013. In connection with the adoption of the new compensation policy, the Board also amended the 2004 Plan as follows: · All unvested deferred stock awards (other than any unvested initial awards) were vested in full on September 16, 2009 unless the date such deferred stock units were credited to the non ‑employee director was less than one year prior to September 16, 2009, in which case such unvested deferred stock units will vest on the first anniversary of the date such deferred stock units were credited to the non ‑employee director. · All unvested deferred stock awards will automatically vest immediately prior to the occurrence of a change of control. On September 22, 2010, the Board revised the Compensation Policy for Non ‑Employee Directors to provide that, in addition to the compensation they received previously, they would also become entitled to receive stock option awards having a grant date fair value of $30,000 , determined using the Black ‑ Scholes option pricing model measured on the date of grant, which would be the date of the annual meeting of shareholders. On November 12, 2013, the Board amended the Compensation Policy for Non ‑Employee Directors to make certain changes to the compensation of its non ‑employee directors, including an increase in the fees paid in cash to the non ‑employee directors. Under the terms of the amended policy, the redemption amount of deferred share units issued will continue to be paid in shares of common stock of the Company on the date a director ceases to be a member of the Board. Annual retainers vest quarterly over approximately one year from the date of grant, contingent upon the individual remaining a director of ImmunoGen as of each vesting date. The number of deferred share units awarded is now fixed per the plan on the date of the award and is no longer based on the market price of the Company’s common stock on the date of the award. All unvested deferred stock awards will automatically vest immediately prior to the occurrence of a change of control. In addition to the deferred share units, the Non ‑Employee Directors are now also entitled to receive a fixed number of stock options instead of a fixed grant date fair value of options, determined using the Black ‑Scholes option pricing model measured on the date of grant, which would be the date of the annual meeting of shareholders. These options vest quarterly over approximately one year from the date of grant. Any new directors will receive a pro ‑rated award, depending on their date of election to the Board. The directors received a total of 80,000 options in each fiscal year ended 2016, 2015 and 2014, and the related compensation expense is included in the amounts discussed in the “Stock ‑Based Compensation” section of footnote B above. Pursuant to the Compensation Policy for Non ‑Employee Directors, as amended, the Company recorded approximately: · $380,000 in compensation expense during the year ended June 30, 2016 related to the grant of 41,000 deferred share units and 12,000 deferred share units previously granted; · $389,000 in compensation expense during the year ended June 30, 2015 related to the grant of 31,000 deferred share units and 15,000 deferred share units previously granted; and · $433,000 in compensation expense during the year ended June 30, 2014 related to the grant of 28,000 deferred share units and 19,000 deferred share units previously granted . |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Jun. 30, 2016 | |
Commitments and Contingencies | |
Commitments and Contingencies | I. Commitments and Contingencies Leases The Company currently has a lease agreement with CRP/King 830 Winter L.L.C. for the rental of approximately 110,000 square feet of laboratory and office space at 830 Winter Street, Waltham, MA through March 2026. The Company uses this space for its corporate headquarters and other operations. The Company may extend the lease for two additional terms of five years. Pursuant to lease amendments executed in December 2013 and April 2014, the Company received construction allowances of approximately $746,000 and $1.1 million, respectively, to build out office and lab space to the Company’s specifications, and will receive up to $196,000 as a construction allowance pursuant to an amendment executed in December 2015. The Company is required to pay certain operating expenses for the leased premises subject to escalation charges for certain expense increases over a base amount. In February 2016, the Company entered into a lease agreement with PDM 930 Unit, LLC for the rental of 10,281 square feet of additional office space at 930 Winter Street, Waltham, MA through August 31, 2021. The Company will receive up to approximately $617,000 as a construction allowance to build out the office space to the Company’s specifications. The Company is required to pay certain operating expenses for the leased premises based on its pro-rata share of such expenses for the entire rentable space of the building. The Company also leases 43,850 square feet of manufacturing and office space at 333 Providence Highway, Norwood, MA under an agreement through 2018 with an option to extend the lease for an additional term of five years. The Company is required to pay certain operating expenses for the leased premises subject to escalation charges for certain expense increases over a base amount. Effective April 2013, the Company entered into a lease agreement with River Ridge Limited Partnership for the rental of 7,507 square feet of additional office space at 100 River Ridge Drive, Norwood, MA. The initial term of the lease was for five years and two months commencing in July 2013 with an option for the Company to extend the lease for an additional term of five years. The Company is required to pay certain operating expenses for the leased premises subject to escalation charges for certain expense increases over a base amount. The Company entered into a sublease in December 2014 for this space, effective January 2015 through the remaining initial term of the lease. Facilities rent expense, net of sublease income, was approximately $6.5 million, $6.0 million and $5.4 million during fiscal years 2016, 2015 and 2014, respectively. As of June 30, 2016, the minimum rental commitments, including real estate taxes and other expenses, for the next five fiscal years and thereafter under the non ‑cancelable operating lease agreements discussed above are as follows (in thousands): 2017 $ 2018 2019 2020 2021 Thereafter Total minimum lease payments $ Total minimum rental income from subleases Total minimum lease payments, net $ There are no obligations under capital leases as of June 30, 2016, as all of the capital leases were single payment obligations which have all been made. Collaborations and Licenses The Company is contractually obligated to make potential future success ‑based regulatory milestone payments in conjunction with certain collaborative agreements. These payments are contingent upon the occurrence of certain future events and, given the nature of these events, it is unclear when, if ever, the Company may be required to pay such amounts. Further, the timing of any future payment is not reasonably estimable. As of June 30, 2014, the maximum amount that may be payable in the future under the Company’s current collaborative agreements is $162 million, $1.4 million of which is reimbursable by a third party under a separate agreement. In addition, The Company is party to a license agreement covering the manufacture of the antibodies used in certain of product candidates which, under certain circumstances, requires periodic payments once the product reaches a specified stage of clinical development, and royalties on commercial sales of the product. The Company believes that the license agreement, by its terms, does not obligate it to make any further payments thereunder and accordingly, has not accrued a potential payment of £300,000 for one of its product candidates that has reached this stage. Litigation The Company is not party to any material litigation. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Jun. 30, 2016 | |
Employee Benefit Plans | |
Employee Benefit Plans | J. Employee Benefit Plans The Company has a deferred compensation plan under Section 401(k) of the Internal Revenue Code (the 401(k) Plan). Under the 401(k) Plan, eligible employees are permitted to contribute, subject to certain limitations, up to 100% of their gross salary and the Company’s matching contribution is 50% of the first 6% of the eligible employees’ contributions. In fiscal years 2016, 2015 and 2014, the Company’s contributions to the 401(k) Plan totaled approximately $1.1 million, $875,000 , and $710,000 , respectively. |
Quarterly Financial Information
Quarterly Financial Information (Unaudited) | 12 Months Ended |
Jun. 30, 2016 | |
Quarterly Financial Information (Unaudited) | |
Quarterly Financial Information (Unaudited) | K. Quarterly Financial Information (Unaudited) Fiscal Year 2016 First Quarter Second Quarter Third Quarter Fourth Quarter Ended Ended Ended Ended September 30, 2015 December 31, 2015 March 31, 2016 June 30, 2016 (In thousands, except per share data) Revenues: License and milestone fees $ $ $ $ Royalty revenue — — — Non-cash royalty revenue related to the sale of future royalties Research and development support Clinical materials revenue Total revenues Expenses: Research and development General and administrative Total expenses Loss from operations Non-cash interest expense on liability related to sale of future royalty and senior convertible notes Other income (expense), net Net loss $ $ $ $ Basic and diluted net loss per common share $ $ $ $ Fiscal Year 2015 First Quarter Second Quarter Third Quarter Fourth Quarter Ended Ended Ended Ended September 30, 2014 December 31, 2014 March 31, 2015 June 30, 2015 (In thousands, except per share data) Revenues: License and milestone fees $ $ $ $ Royalty revenue Non-cash royalty revenue related to the sale of future royalties — — — Research and development support Clinical materials revenue Total revenues Expenses: Research and development General and administrative Total expenses (Loss) income from operations Non-cash interest expense on liability related to sale of future royalty — — — Other (expense) income, net Net (loss) income $ $ $ $ Basic and diluted net (loss) income per common share $ $ $ $ |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Jun. 30, 2016 | |
Summary of Significant Accounting Policies | |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, ImmunoGen Securities Corp., ImmunoGen Europe Limited and Hurricane, LLC. All intercompany transactions and balances have been eliminated. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States (U.S.) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Subsequent Events | Subsequent Events The Company has evaluated all events or transactions that occurred after June 30, 2016 up through the date the Company issued these financial statements. The Company did not have any material recognizable or unrecognizable subsequent events. |
Related party transaction | Related party transaction During fiscal year 2016, the Company entered into a transaction with Sanofi to purchase drug product along with the master and working cell banks for a product that Sanofi previously discontinued and had returned its rights back to the Company. The Company entered into this transaction, at a cost of €1.6 million, in order to continue development of the product, or make it more attractive to re-license the target to another partner. A relationship between an executive from the Company and an executive from Sanofi qualified this transaction as potentially between related parties, and accordingly, the audit committee of the Board of Directors of the Company approved the terms and conditions of the transaction, believing that it was in the best interest of the Company to proceed and that it was done at an arms-length amount. The transaction was substantially completed during the year; however, as of June 30, 2016, $44,000 is classified as a prepaid expense and approximately $258,000 more will be payable when a deliverable still pending from Sanofi is received. |
Revenue Recognition | Revenue Recognition The Company enters into licensing and development agreements with collaborative partners for the development of monoclonal antibody ‑based anticancer therapeutics. The terms of these agreements contain multiple deliverables which may include (i) licenses, or options to obtain licenses, to the Company’s antibody ‑drug conjugate, or ADC, technology, (ii) rights to future technological improvements, (iii) research activities to be performed on behalf of the collaborative partner, (iv) delivery of cytotoxic agents and (v) the manufacture of preclinical or clinical materials for the collaborative partner. Payments to the Company under these agreements may include upfront fees, option fees, exercise fees, payments for research activities, payments for the manufacture of preclinical or clinical materials, payments based upon the achievement of certain milestones and royalties on product sales. The Company follows the provisions of the Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 605 ‑25, “Revenue Recognition—Multiple ‑Element Arrangements,” and ASC Topic 605 ‑28, “Revenue Recognition—Milestone Method,” in accounting for these agreements. In order to account for these agreements, the Company must identify the deliverables included within the agreement and evaluate which deliverables represent separate units of accounting based on whether certain criteria are met, including whether the delivered element has stand ‑alone value to the collaborator. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. At June 30, 2016, the Company had the following two types of agreements with the parties identified below: · Development and commercialization licenses, which provide the party with the right to use the Company’s ADC technology and/or certain other intellectual property to develop compounds to a specified antigen target: Amgen ( two exclusive single-target licenses (1) ) Bayer ( one exclusive single-target license) Biotest ( one exclusive single-target license) CytomX ( one exclusive single-target license) Lilly ( three exclusive single-target licenses) Novartis ( five exclusive single-target licenses and one license to two related targets: one target on an exclusive basis and the second target on a non-exclusive basis) Roche, through its Genentech unit ( five exclusive single-target licenses) Sanofi ( one exclusive single-target license and one exclusive license to multiple individual targets) Takeda, through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc. ( one exclusive single-target license) (1) Amgen has sublicensed one of its exclusive single-target licenses to Oxford BioTherapeutics Ltd. · Research license/option agreement for a defined period of time to secure development and commercialization licenses to use the Company’s ADC technology to develop anticancer compounds to specified targets on established terms (referred to herein as right-to-test agreements): CytomX Takeda, through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc. There are no performance, cancellation, termination or refund provisions in any of the arrangements that contain material financial consequences to the Company. Development and Commercialization Licenses The deliverables under a development and commercialization license agreement generally include the license to the Company’s ADC technology with respect to a specified antigen target, and may also include deliverables related to rights to future technological improvements, research activities to be performed on behalf of the collaborative partner and the manufacture of preclinical or clinical materials for the collaborative partner. Generally, development and commercialization licenses contain non ‑refundable terms for payments and, depending on the terms of the agreement, provide that the Company will (i) at the collaborator’s request, provide research services at negotiated prices which are generally consistent with what other third parties would charge, (ii) at the collaborator’s request, manufacture and provide to it preclinical and clinical materials or deliver cytotoxic agents at negotiated prices which are generally consistent with what other third parties would charge, (iii) earn payments upon the achievement of certain milestones and (iv) earn royalty payments, generally until the later of the last applicable patent expiration or 10 to 12 years after product launch. In the case of Kadcyla, however, the minimum royalty term is 10 years and the maximum royalty term is 12 years on a country ‑by ‑country basis, regardless of patent protection. Royalty rates may vary over the royalty term depending on the Company’s intellectual property rights and/or the presence of comparable competing products. The Company may provide technical assistance and share any technology improvements with its collaborators during the term of the collaboration agreements. The Company does not directly control when or whether any collaborator will request research or manufacturing services, achieve milestones or become liable for royalty payments. As a result, the Company cannot predict when or if it will recognize revenues in connection with any of the foregoing. In determining the units of accounting, management evaluates whether the license has stand ‑alone value from the undelivered elements to the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research capabilities of the partner and the availability of ADC technology research expertise in the general marketplace. If the Company concludes that the license has stand ‑alone value and therefore will be accounted for as a separate unit of accounting, the Company then determines the estimated selling prices of the license and all other units of accounting based on market conditions, similar arrangements entered into by third parties, and entity ‑specific factors such as the terms of the Company’s previous collaborative agreements, recent preclinical and clinical testing results of therapeutic products that use the Company’s ADC technology, the Company’s pricing practices and pricing objectives, the likelihood that technological improvements will be made, and, if made, will be used by the Company’s collaborators and the nature of the research services to be performed on behalf of its collaborators and market rates for similar services. Upfront payments on development and commercialization licenses may be recognized upon delivery of the license if facts and circumstances dictate that the license has stand ‑alone value from the undelivered elements, which generally include rights to future technological improvements, research services, delivery of cytotoxic agents and the manufacture of preclinical and clinical materials. The Company recognizes revenue related to research services that represent separate units of accounting as they are performed, as long as there is persuasive evidence of an arrangement, the fee is fixed or determinable, and collection of the related receivable is probable. The Company recognizes revenue related to the rights to future technological improvements over the estimated term of the applicable license. The Company may also provide cytotoxic agents to its collaborators or produce preclinical and clinical materials at negotiated prices which are generally consistent with what other third parties would charge. The Company recognizes revenue on cytotoxic agents and on preclinical and clinical materials when the materials have passed all quality testing required for collaborator acceptance and title and risk of loss have transferred to the collaborator. Arrangement consideration allocated to the manufacture of preclinical and clinical materials in a multiple ‑deliverable arrangement is below the Company’s full cost, and the Company’s full cost is not expected to ever be below its contract selling prices for its existing collaborations. During the fiscal years ended June 30, 2016, 2015 and 2014, the difference between the Company’s full cost to manufacture preclinical and clinical materials on behalf of its collaborators as compared to total amounts received from collaborators for the manufacture of preclinical and clinical materials was $ 6.9 million, $9.2 million and $2.3 million, respectively. The majority of the Company’s costs to produce these preclinical and clinical materials are fixed and then allocated to each batch based on the number of batches produced during the period. Therefore, the Company’s costs to produce these materials are significantly impacted by the number of batches produced during the period. The volume of preclinical and clinical materials the Company produces is directly related to the number of clinical trials the Company and its collaborators are preparing for or currently have underway, the speed of enrollment in those trials, the dosage schedule of each clinical trial and the time period such trials last. Accordingly, the volume of preclinical and clinical materials produced, and therefore the Company’s per ‑batch costs to manufacture these preclinical and clinical materials, may vary significantly from period to period. The Company may also produce research material for potential collaborators under material transfer agreements. Additionally, the Company performs research activities, including developing antibody specific conjugation processes, on behalf of its collaborators and potential collaborators during the early evaluation and preclinical testing stages of drug development. The Company records amounts received for research materials produced or services performed as a component of research and development support revenue. The Company also develops conjugation processes for materials for later stage testing and commercialization for certain collaborators. The Company is compensated at negotiated rates and may receive milestone payments for developing these processes which are recorded as a component of research and development support revenue. The Company’s development and commercialization license agreements have milestone payments which for reporting purposes are aggregated into three categories: (i) development milestones, (ii) regulatory milestones, and (iii) sales milestones. Development milestones are typically payable when a product candidate initiates or advances into different clinical trial phases. Regulatory milestones are typically payable upon submission for marketing approval with the U.S. Food and Drug Administration, or FDA, or other countries’ regulatory authorities or on receipt of actual marketing approvals for the compound or for additional indications. Sales milestones are typically payable when annual sales reach certain levels. At the inception of each agreement that includes 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. Non ‑refundable development and regulatory milestones that are expected to be achieved as a result of the Company’s efforts during the period of substantial involvement are considered substantive and are recognized as revenue upon the achievement of the milestone, assuming all other revenue recognition criteria are met. Milestones that are not considered substantive because we do not contribute effort to the achievement of such milestones are generally achieved after the period of substantial involvement and are recognized as revenue upon achievement of the milestone, as there are no undelivered elements remaining and no continuing performance obligations, assuming all other revenue recognition criteria are met. Under the Company’s development and commercialization license agreements, the Company receives royalty payments based upon its licensees’ net sales of covered products. Generally, under these agreements the Company is to receive royalty reports and payments from its licensees approximately one quarter in arrears, that is, generally in the second or third month of the quarter after the licensee has sold the royalty bearing product or products. The Company recognizes royalty revenues when it can reliably estimate such amounts and collectability is reasonably assured. As such, the Company generally recognizes royalty revenues in the quarter reported to the Company by its licensees, or one quarter following the quarter in which sales by the Company’s licensees occurred. Right ‑to ‑Test Agreements The Company’s right ‑to ‑test agreements provide collaborators the right to (a) test the Company’s ADC technology for a defined period of time through a research, or right ‑to ‑test, license, (b) take options, for a defined period of time, to specified targets and (c) upon exercise of those options, secure or “take” licenses to develop and commercialize products for the specified targets on established terms. Under these agreements, fees may be due to the Company (i) at the inception of the arrangement (referred to as “upfront” fees or payments), (ii) upon taking an option with respect to a specific target (referred to as option fees or payments earned, if any, when the option is “taken”), (iii) upon the exercise of a previously taken option to acquire a development and commercialization license(s) (referred to as exercise fees or payments earned, if any, when the development and commercialization license is “taken”), or (iv) some combination of all of these fees. The accounting for right to test agreements is dependent on the nature of the options granted to the collaborative partner. Options are considered substantive if, at the inception of a right to test agreement, the Company is at risk as to whether the collaborative partner will choose to exercise the options to secure development and commercialization licenses. Factors that are considered in evaluating whether options are substantive include the overall objective of the arrangement, the benefit the collaborator might obtain from the agreement without exercising the options, the cost to exercise the options relative to the total upfront consideration, and the additional financial commitments or economic penalties imposed on the collaborator as a result of exercising the options. None of the Company’s right to test agreements entered into subsequent to the adoption of Accounting Standards Update, or ASU, No. 2009 13, “Revenue Arrangements with Multiple Deliverables” on July 1, 2010 has been determined to contain substantive options. For right to test agreements where the options to secure development and commercialization licenses to the Company’s ADC technology are not considered substantive, the Company considers the development and commercialization licenses to be a deliverable at the inception of the agreement and applies the multiple element revenue recognition criteria to determine the appropriate revenue recognition. Subsequent to the adoption of ASU No. 2009-13, the Company determined that its research licenses lack stand-alone value and are considered for aggregation with the other elements of the arrangement and accounted for as one unit of accounting. The Company does not directly control when or if any collaborator will exercise its options for development and commercialization licenses. As a result, the Company cannot predict when or if it will recognize revenues in connection with any of the foregoing. |
Inventory | Inventory Inventory costs relate to clinical trial materials being manufactured for sale to the Company’s collaborators. Inventory is stated at the lower of cost or market as determined on a first ‑in, first ‑out (FIFO) basis. Inventory at June 30, 2016 and 2015 is summarized below (in thousands): June 30, 2016 2015 Raw materials $ $ Work in process Total $ $ Raw materials inventory consists entirely of proprietary cell ‑killing agents the Company developed as part of its ADC technology. All raw materials inventory is currently procured from two suppliers. Work in process inventory consists of conjugate manufactured for sale to the Company’s collaborators to be used in preclinical and clinical studies. All conjugate is made to order at the request of the collaborators and subject to the terms and conditions of respective supply agreements. As such, no excess reserve for work in process inventory is required. As discussed above, the Company’s costs to manufacture conjugate on behalf of its partners are greater than the supply prices charged to partners, and therefore costs are capitalized into inventory at the supply prices. Raw materials inventory cost is stated net of write ‑downs of $1.4 million as of June 30, 2016 and June 30, 2015. The write ‑downs represent the cost of raw materials that the Company considers to be in excess of a twelve ‑month supply based on firm, fixed orders and projections from its collaborators as of the respective balance sheet date. Due to yield fluctuations, the actual amount of raw materials that will be produced in future periods under third ‑party supply agreements is highly uncertain. As such, the amount of raw materials produced could be more than is required to support the development of the Company’s collaborators’ product candidates. Such excess supply, as determined under the Company’s inventory reserve policy, is charged to research and development expense. The Company produces preclinical and clinical materials for its collaborators either in anticipation of or in support of preclinical studies and clinical trials, or for process development and analytical purposes. Under the terms of supply agreements with its collaborators, the Company generally receives rolling six ‑month firm, fixed orders for conjugate that the Company is required to manufacture, and rolling twelve ‑month manufacturing projections for the quantity of conjugate the collaborator expects to need in any given twelve ‑month period. The amount of clinical material produced is directly related to the number of collaborator anticipated or on ‑going clinical trials for which the Company is producing clinical material, the speed of enrollment in those trials, the dosage schedule of each clinical trial and the time period, if any, during which patients in the trial receive clinical benefit from the clinical materials. Because these elements are difficult to estimate over the course of a trial, substantial differences between collaborators’ actual manufacturing orders and their projections could result in the Company’s usage of raw materials varying significantly from estimated usage at an earlier reporting period. To the extent that a collaborator has provided the Company with a firm, fixed order, the collaborator is required by contract to reimburse the Company the full negotiated price of the conjugate, even if the collaborator subsequently cancels the manufacturing run. The Company capitalizes raw material as inventory upon receipt and accounts for the raw material inventory as follows: a) to the extent that the Company has up to twelve months of firm, fixed orders and/or projections from its collaborators, the Company capitalizes the value of raw materials that will be used in the production of conjugate subject to these firm, fixed orders and/or projections; b) the Company considers more than a twelve month supply of raw materials that is not supported by firm, fixed orders and/or projections from its collaborators to be excess and establishes a reserve to reduce to zero the value of any such excess raw material inventory with a corresponding charge to research and development expense; and c) the Company also considers any other external factors and information of which it becomes aware and assesses the impact of such factors or information on the net realizable value of the raw material inventory at each reporting period. During fiscal years 2016, 2015 and 2014, the Company obtained additional amounts of its cell-killing agents DMx from its supplier which yielded more material than would be required by the Company’s collaborators over the next twelve months, and as a result, the Company recorded $1.1 million, $1.0 million and $364,000 ,respectively, of charges to research and development expense related to raw material inventory identified as excess. Increases in the Company’s on ‑hand supply of raw materials, or a reduction to the Company’s collaborators’ projections, could result in significant changes in the Company’s estimate of the net realizable value of such raw material inventory. Reductions in collaborators’ projections could indicate that the Company has excess raw material inventory and the Company would then evaluate the need to record write ‑downs as charges to research and development expense. |
Unbilled Revenue | Unbilled Revenue The majority of the Company’s unbilled revenue at June 30, 2016 and 2015 represents research funding earned based on actual resources utilized under the Company’s various collaborator agreements. |
Other Accrued Liabilities | Other Accrued Liabilities Other accrued liabilities consisted of the following at June 30, 2016 and 2015 (in thousands): June 30, 2016 2015 Accrued contract payments $ $ Accrued clinical trial costs Accrued professional services Accrued employee benefits Accrued public reporting charges Other current accrued liabilities Total $ $ |
Research and Development Expenses | Research and Development Expenses The Company’s research and development expenses are charged to expense as incurred and relate to (i) research to evaluate new targets and to develop and evaluate new antibodies, linkers and cytotoxic agents, (ii) preclinical testing of its own and, in certain instances, its collaborators’ product candidates, and the cost of its own clinical trials, (iii) development related to clinical and commercial manufacturing processes and (iv) manufacturing operations which also include raw materials. Payments made by the Company in advance for research and development services not yet provided and/or materials not yet delivered and accepted are recorded as prepaid expenses and are included in the accompanying Consolidated Balance Sheets as prepaid and other current assets. |
Income Taxes | Income Taxes The Company uses the liability method to account for income taxes. Deferred tax assets and liabilities are determined based on differences between the financial reporting and income tax basis of assets and liabilities, as well as net operating loss carry forwards and tax credits and are measured using the enacted tax rates and laws that will be in effect when the differences reverse. A valuation allowance against net deferred tax assets is recorded if, based on the available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. |
Financial Instruments and Concentration of Credit Risk | Financial Instruments and Concentration of Credit Risk Cash and cash equivalents are primarily maintained with three financial institutions in the U.S. Deposits with banks may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk. The Company’s cash equivalents consist of money market funds with underlying investments primarily being U.S. Government ‑ issued securities and high quality, short ‑term commercial paper. Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and marketable securities. The Company held no marketable securities as of June 30, 2016. The Company’s investment policy, approved by the Board of Directors, limits the amount it may invest in any one type of investment, thereby reducing credit risk concentrations. |
Cash and Cash Equivalents | Cash and Cash Equivalents All highly liquid financial instruments with maturities of three months or less when purchased are considered cash equivalents. As of June 30, 2016 and June 30, 2015, the Company held $245.0 million and $ 278.1 million, respectively, in cash and money market funds consisting principally of U.S. Government-issued securities and high quality, short-term commercial paper which were classified as cash and cash equivalents. |
Non-cash Investing Activities | Non-cash Investing Activities The Company had $804,000 of accrued capital expenditures as of June 30, 2016 which have been treated as a non-cash investing activity and, accordingly, are not reflected in the consolidated statement of cash flows. Accrued capital expenditures as of June 30, 2015 were not material and are included in the consolidated statement of cash flows. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments ASC Topic 820 defines fair value, establishes a framework for measuring fair value in accordance with accounting principles generally accepted in the U.S., and expands disclosures about fair value measurements. Fair value is defined under ASC Topic 820 as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes a fair value hierarchy to measure fair value which is based on three levels of inputs, of which the first two are considered observable and the last unobservable, as follows: · Level 1—Quoted prices in active markets for identical assets or liabilities. · Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. · Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. As of June 30, 2016, the Company held certain assets that are required to be measured at fair value on a recurring basis. The following table represents the fair value hierarchy for the Company’s financial assets measured at fair value on a recurring basis as of June 30, 2016 (in thousands): Fair Value Measurements at June 30, 2016 Using Quoted Prices in Significant Active Markets for Significant Other Unobservable Identical Assets Observable Inputs Inputs Total (Level 1) (Level 2) (Level 3) Cash equivalents $ $ $ — $ — As of June 30, 2015, the Company held certain assets that are required to be measured at fair value on a recurring basis. The following table represents the fair value hierarchy for the Company’s financial assets measured at fair value on a recurring basis as of June 30, 2015 (in thousands): Fair Value Measurements at June 30, 2015 Using Quoted Prices in Significant Active Markets for Significant Other Unobservable Identical Assets Observable Inputs Inputs Total (Level 1) (Level 2) (Level 3) Cash equivalents $ $ $ — $ — The fair value of the Company’s cash equivalents is based primarily on quoted prices from active markets. The carrying amounts reflected in the consolidated balance sheets for accounts receivable, unbilled revenue, prepaid and other current assets, accounts payable, accrued compensation, and other accrued liabilities approximate fair value due to their short ‑term nature. The carrying amount and estimated fair value of the convertible 4.5% senior notes was $100.0 million and $91.2 million, respectively, as of June 30, 2016. The fair value of the Convertible Notes is influenced by interest rates, the Company’s stock price and stock price volatility and is determined by prices for the Convertible Notes observed in a market which is a Level 2 input for fair value purposes. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost. The Company provides for depreciation based upon expected useful lives using the straight ‑line method over the following estimated useful lives: Machinery and equipment 5 years Computer hardware and software 3 years Furniture and fixtures 5 years Leasehold improvements Shorter of remaining lease term or 7 years Equipment under capital leases is amortized over the lives of the respective leases or the estimated useful lives of the assets, whichever is shorter, and included in depreciation expense. Maintenance and repairs are charged to expense as incurred. Upon retirement or sale, the cost of disposed assets and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the statement of operations. The Company recorded $ 21,000 , $(7,000) and $(20,000 ) of gains (losses) on the sale/disposal of certain furniture and equipment during the years ended June 30, 2016, 2015, and 2014, respectively. |
Impairment of Long-Lived Assets | Impairment of Long ‑Lived Assets In accordance with ASC Topic 360, “Property, Plant, and Equipment,” the Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its long ‑lived assets may warrant revision or that the carrying value of these assets may be impaired if impairment indicators are present. The Company evaluates the realizability of its long ‑lived assets based on cash flow expectations for the related asset. Any write ‑downs to fair value are treated as permanent reductions in the carrying amount of the assets. Based on this evaluation, the Company believes that, as of each of the balance sheet dates presented, none of the Company’s long ‑lived assets were impaired. |
Computation of Net Loss per Common Share | Computation of Net Loss per Common Share Basic and diluted net loss per share is calculated based upon the weighted average number of common shares outstanding during the period. During periods of income, participating securities are allocated a proportional share of income determined by dividing total weighted average participating securities by the sum of the total weighted average common shares and participating securities (the “two ‑class method”). Shares of the Company’s restricted stock participate in any dividends that may be declared by the Company and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods of loss, no loss is allocated to participating securities since they have no contractual obligation to share in the losses of the Company. Diluted (loss) income per share is computed after giving consideration to the dilutive effect of stock options that are outstanding during the period, except where such non-participating securities would be anti-dilutive. The Company’s common stock equivalents, as calculated in accordance with the treasury ‑stock method for the options and the if-converted method for the convertible notes, are shown in the following table (in thousands): June 30, 2016 2015 2014 Options outstanding to purchase common stock and unvested restricted stock Common stock equivalents under treasury stock method for options Shares issuable upon conversion of convertible notes — — Common stock equivalents under if-converted method for convertible notes — — The Company’s common stock equivalents have not been included in the net loss per share calculation because their effect is anti ‑dilutive due to the Company’s net loss position. |
Stock-Based Compensation | Stock ‑based Compensation As of June 30, 2015, the Company is authorized to grant future awards under one employee share ‑based compensation plan, which is the ImmunoGen, Inc. 2006 Employee, Director and Consultant Equity Incentive Plan, or the 2006 Plan. At the annual meeting of shareholders on November 11, 2014, an amendment to the 2006 Plan was approved and an additional 5,500,000 shares were authorized for issuance under this plan. As amended, the 2006 Plan provides for the issuance of Stock Grants, the grant of Options and the grant of Stock ‑Based Awards for up to 17,500,000 shares of the Company’s common stock, as well as 1,676,599 shares of common stock which represent awards granted under the previous stock option plan, the ImmunoGen, Inc. Restated Stock Option Plan, or the Former Plan, that were forfeited, expired or were cancelled without delivery of shares of common stock or which resulted in the forfeiture of shares of common stock back to the Company between November 11, 2006 and June 30, 2014. Option awards are granted with an exercise price equal to the market price of the Company’s stock at the date of grant. Options vest at various periods of up to four years and may be exercised within ten years of the date of grant. The stock ‑based awards are accounted for under ASC Topic 718, “Compensation—Stock Compensation.” Pursuant to Topic 718, the estimated grant date fair value of awards is charged to the statement of operations over the requisite service period, which is the vesting period. Such amounts have been reduced by an estimate of forfeitures of all unvested awards. The fair value of each stock option is estimated on the date of grant using the Black ‑ Scholes option ‑pricing model with the weighted average assumptions noted in the following table. As the Company has not paid dividends since inception, nor does it expect to pay any dividends for the foreseeable future, the expected dividend yield assumption is zero . Expected volatility is based exclusively on historical volatility data of the Company’s stock. The expected term of stock options granted is based exclusively on historical data and represents the period of time that stock options granted are expected to be outstanding. The expected term is calculated for and applied to one group of stock options as the Company does not expect substantially different exercise or post ‑vesting termination behavior amongst its employee population. The risk ‑free rate of the stock options is based on the U.S. Treasury rate in effect at the time of grant for the expected term of the stock options. Year Ended June 30, 2016 2015 2014 Dividend None None None Volatility % % % Risk-free interest rate % % % Expected life (years) Using the Black ‑Scholes option ‑pricing model, the weighted average grant date fair values of options granted during fiscal years 2016, 2015 and 2014 were $8.91 , $6.04 , and $10.50 per share, respectively. A summary of option activity under the 2006 Plan as of June 30, 2016, and changes during the twelve month period then ended is presented below (in thousands, except weighted ‑average data): Weighted ‑ Weighted ‑ Number of Average Average Aggregate Stock Exercise Remaining Intrinsic Options Price Life in Yrs Value Outstanding at June 30, 2015 $ Granted $ Exercised $ Forfeited/Canceled $ Outstanding at June 30, 2016 $ $ — Outstanding at June 30, 2016—vested or unvested and expected to vest $ $ — Exercisable at June 30, 2016 $ $ — In May 2016, November 2012 and January 2015, the Company granted th ree officers of the Company 75,000 , 50,000 and 25,000 shares of restricted stock, respectively, upon hire. Pursuant to the agreements, the shares vest ratably in annual installments over the subsequent four years. The fair value of the restricted stock was determined by the closing price on the date of grant. A summary of restricted stock activity under the 2006 Plan as of June 30, 2016, and changes during the twelve month period then ended is presented below (in thousands, except weighted ‑average data): Weighted ‑ Number of Average Restricted Exercise Stock Shares Price Unvested at June 30, 2015 $ Awarded $ Vested $ Unvested at June 30, 2016 $ In August 2016, the Company granted 117,800 shares of restricted common stock to certain officers of the Company. These restrictions will lapse in three equal installments over five years upon the achievement of specified performance goals. Stock compensation expense related to stock options and restricted stock awards granted under the 2006 Plan was $21.9 million, $15.3 million and $15.6 million during the fiscal years ended June 30, 2016, 2015, and 2014, respectively. During fiscal year 2016, the Company recorded approximately $3.1 million of stock compensation cost related to the modification of certain outstanding common stock options with the former Chief Executive Officer’s succession plan. No similar charges were recorded in fiscal years 2015 and 2014. As of June 30, 2016, the estimated fair value of unvested employee awards was approximately $26.6 million, net of estimated forfeitures. The weighted ‑average remaining vesting period for these awards is approximately two years. Included in stock compensation expense for the fiscal years ended June 30, 2016, 2015 and 2014 are $380,000 , $389,000 and $433,000 , respectively, of expense recorded for directors’ deferred share units, the details of which are discussed in Note H of the Company’s consolidated financial statements. A summary of option activity for options vested during the fiscal years ended June 30, 2016, 2015 and 2014 is presented below (in thousands): Year Ended June 30, 2016 2015 2014 Total fair value of options vested $ $ $ Total intrinsic value of options exercised Cash received for exercise of stock options |
Comprehensive Loss | Comprehensive Loss The Company presents comprehensive loss in accordance with ASC Topic 220, Comprehensive Income. Comprehensive loss is comprised of the Company’s net loss for the years ended June 30, 2016, 2015 and 2014. |
Segment Information | Segment Information During the three fiscal years ended June 30, 2016, the Company continued to operate in one reportable business segment under the management approach of ASC Topic 280, Segment Reporting , which is the business of discovery of monoclonal antibody ‑based anticancer therapeutics. The percentages of revenues recognized from significant customers of the Company in the years ended June 30, 2016, 2015 and 2014 are included in the following table: Year Ended June 30, Collaborative Partner: 2016 2015 2014 Bayer % — % — % Lilly % % % Novartis % % % Roche % % % Takeda % — % — % There were no other customers of the Company with significant revenues in the years ended June 30, 2016, 2015 and 2014. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the FASB issued ASU 2014 ‑9, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), to clarify the principles for recognizing revenue. This update provides a comprehensive new revenue recognition model that requires revenue to be recognized in a manner to depict the transfer of goods or services to a customer at an amount that reflects the consideration expected to be received in exchange for those goods or services. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date , which delayed the effective date of the new standard from January 1, 2017 to January 1, 2018. The FASB also agreed to allow entities to choose to adopt the standard as of the original effective date. In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations , which clarifies the implementation guidance on principal versus agent considerations. In April 2016, the FASB issued ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing , which clarifies certain aspects of identifying performance obligations and licensing implementation guidance. In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients related to disclosures of remaining performance obligations, as well as other amendments to guidance on collectibility, non-cash consideration and the presentation of sales and other similar taxes collected from customers. These standards have the same effective date and transition date of January 1, 2018. The new revenue standard allows for either full retrospective or modified retrospective application. The Company is currently evaluating the timing of its adoption, the transition method to apply and the impact that this guidance will have on its consolidated financial statements and related 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. This new standard gives a company’s management the final responsibilities to decide whether there’s substantial doubt about the company’s ability to continue as a going concern and to provide related footnote disclosures. The standard provides guidance to management, with principles and definitions that are intended to reduce diversity in the timing and content of disclosures that companies commonly provide in their footnotes. Under the new standard, management must decide whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the company’s ability to continue as a going concern within one year after the date that the financial statements are issued, or within one year after the date that the financial statements are available to be issued when applicable. This guidance is effective for annual reporting beginning after December 15, 2016, including interim periods within the year of adoption, with early application permitted. Accordingly, the standard is effective for the Company on January 1, 2017. The Company has not yet completed its analysis of the impact of the adoption of this guidance. Refer to Note A, Nature of Business and Plan of Operations for further discussion. In April 2015, the FASB issued ASU 2015-03, Interest-Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs. To simplify presentation of debt issuance costs, this new standard requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected by this update. This guidance is effective for annual reporting beginning after December 15, 2015, including interim periods within the year of adoption, and calls for retrospective application, with early application permitted. Accordingly, the standard is effective for the Company on July 1, 2016. The Company’s consolidated balance sheet as of June 30, 2016 includes in assets $7.8 million of debt issuance costs classified as deferred financing costs. In July 2015, the FASB issued ASU 2015-11, Simplifying the Measurement of Inventory (Topic 330). T o simplify the principles for subsequent measurement of inventory, this new standard requires inventory measured using any method other than LIFO or the retail method shall be measured at the lower of cost and net realizable value, rather than lower of cost or market. This guidance is effective for annual reporting beginning after December 15, 2016, including interim periods within the year of adoption, and calls for prospective application, with early application permitted. Accordingly, the standard is effective for the Company on January 1, 2017. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements. In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes (Topic 740). To simplify the presentation of deferred income taxes, the amendments in this Update require that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. This guidance is effective for annual reporting beginning after December 15, 2016, including interim periods within the year of adoption, with early application permitted. The Company implemented the recommendations of this Update prospectively in the second quarter of fiscal year 2016, resulting in a reduction of long-term assets and current liabilities of approximately $843,000 as of December 31, 2015. The prior period balances were not retrospectively adjusted. In January 2016, the FASB issued ASU 2016-1, Recognition and Measurement of Financial Assets and Financial Liabilities (Topic 825). The amendments in this Update supersede the guidance to classify equity securities with readily determinable fair values into different categories (that is, trading or available-for-sale) and require equity securities (including other ownership interests, such as partnerships, unincorporated joint ventures, and limited liability companies) to be measured at fair value with changes in the fair value recognized through net income. The amendments allow equity investments that do not have readily determinable fair values to be remeasured at fair value either upon the occurrence of an observable price change or upon identification of an impairment. The amendments also require enhanced disclosures about those investments. The amendments improve financial reporting by providing relevant information about an entity’s equity investments and reducing the number of items that are recognized in other comprehensive income. This guidance is effective for annual reporting beginning after December 15, 2017, including interim periods within the year of adoption, and calls for prospective application, with early application permitted. Accordingly, the standard is effective for the Company on January 1, 2018. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements. In February 2016, the FASB issued ASU 2016-2, Leases (Topic 842) that primarily requires lessees to recognize most leases on their balance sheets but record expenses on their income statements in a manner similar to current accounting. For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, and calls for retrospective application, with early adoption permitted. Accordingly, the standard is effective for the Company on January 1, 2019. The Company is currently evaluating the impact of this guidance on our financial statements and the timing of adoption. In March 2016, the FASB issued ASU 2016-9, Improvements to Employee Share-Based Payment Accounting (Topic 718) that changes the accounting for certain aspects of share-based payments to employees. The guidance requires the recognition of the income tax effects of awards in the income statement when the awards vest or are settled, thus eliminating additional paid in capital pools. The guidance also allows for the employer to repurchase more of an employee’s shares for tax withholding purposes without triggering liability accounting. In addition, the guidance allows for a policy election to account for forfeitures as they occur rather than on an estimated basis. The guidance is effective for annual periods beginning after December 15, 2016, and interim periods within those annual periods with early adoption permitted. Accordingly, the standard is effective for the Company on January 1, 2017. The Company is currently evaluating the impact of this guidance on our financial statements and the timing of adoption. |
Summary of Significant Accoun20
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Jun. 30, 2016 | |
Summary of Significant Accounting Policies | |
Schedule of inventory | Inventory at June 30, 2016 and 2015 is summarized below (in thousands): June 30, 2016 2015 Raw materials $ $ Work in process Total $ $ |
Schedule of components of other accrued liabilities | Other accrued liabilities consisted of the following at June 30, 2016 and 2015 (in thousands): June 30, 2016 2015 Accrued contract payments $ $ Accrued clinical trial costs Accrued professional services Accrued employee benefits Accrued public reporting charges Other current accrued liabilities Total $ $ |
Schedule of assets that are required to be measured at fair value on a recurring basis | The following table represents the fair value hierarchy for the Company’s financial assets measured at fair value on a recurring basis as of June 30, 2016 (in thousands): Fair Value Measurements at June 30, 2016 Using Quoted Prices in Significant Active Markets for Significant Other Unobservable Identical Assets Observable Inputs Inputs Total (Level 1) (Level 2) (Level 3) Cash equivalents $ $ $ — $ — As of June 30, 2015, the Company held certain assets that are required to be measured at fair value on a recurring basis. The following table represents the fair value hierarchy for the Company’s financial assets measured at fair value on a recurring basis as of June 30, 2015 (in thousands): Fair Value Measurements at June 30, 2015 Using Quoted Prices in Significant Active Markets for Significant Other Unobservable Identical Assets Observable Inputs Inputs Total (Level 1) (Level 2) (Level 3) Cash equivalents $ $ $ — $ — |
Schedule of estimated useful lives of property and equipment | Machinery and equipment 5 years Computer hardware and software 3 years Furniture and fixtures 5 years Leasehold improvements Shorter of remaining lease term or 7 years |
Schedule of common stock equivalents, as calculated in accordance with the treasury-stock method | The Company’s common stock equivalents, as calculated in accordance with the treasury ‑stock method for the options and the if-converted method for the convertible notes, are shown in the following table (in thousands): June 30, 2016 2015 2014 Options outstanding to purchase common stock and unvested restricted stock Common stock equivalents under treasury stock method for options Shares issuable upon conversion of convertible notes — — Common stock equivalents under if-converted method for convertible notes — — |
Schedule of risk-free rate of the stock options based on US Treasury rate | Year Ended June 30, 2016 2015 2014 Dividend None None None Volatility % % % Risk-free interest rate % % % Expected life (years) |
Summary of stock option activity | A summary of option activity under the 2006 Plan as of June 30, 2016, and changes during the twelve month period then ended is presented below (in thousands, except weighted ‑average data): Weighted ‑ Weighted ‑ Number of Average Average Aggregate Stock Exercise Remaining Intrinsic Options Price Life in Yrs Value Outstanding at June 30, 2015 $ Granted $ Exercised $ Forfeited/Canceled $ Outstanding at June 30, 2016 $ $ — Outstanding at June 30, 2016—vested or unvested and expected to vest $ $ — Exercisable at June 30, 2016 $ $ — |
Summary of restricted stock activity | A summary of restricted stock activity under the 2006 Plan as of June 30, 2016, and changes during the twelve month period then ended is presented below (in thousands, except weighted ‑average data): Weighted ‑ Number of Average Restricted Exercise Stock Shares Price Unvested at June 30, 2015 $ Awarded $ Vested $ Unvested at June 30, 2016 $ |
Summary of vested stock option activity | A summary of option activity for options vested during the fiscal years ended June 30, 2016, 2015 and 2014 is presented below (in thousands): Year Ended June 30, 2016 2015 2014 Total fair value of options vested $ $ $ Total intrinsic value of options exercised Cash received for exercise of stock options |
Schedule of percentage of total revenues recognized from each significant customer | Year Ended June 30, Collaborative Partner: 2016 2015 2014 Bayer % — % — % Lilly % % % Novartis % % % Roche % % % Takeda % — % — % |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Jun. 30, 2016 | |
Property and Equipment | |
Schedule of components of property and equipment | Property and equipment consisted of the following at June 30, 2016 and 2015 (in thousands): June 30, 2016 2015 Leasehold improvements $ $ Machinery and equipment Computer hardware and software Furniture and fixtures Assets under construction $ $ Less accumulated depreciation Property and equipment, net $ $ |
Liability Related to Sale of 22
Liability Related to Sale of Future Royalties (Tables) | 12 Months Ended |
Jun. 30, 2016 | |
Liability Related to Sale of Future Royalties | |
Schedule of Liability account during the period from the inception of the royalty transaction | The following table shows the activity within the liability account during the year ended June 30, 2016 (in thousands): Year Period from ended inception to June 30, June 30, 2016 2016 Liability related to sale of future royalties — beginning balance $ $ — Proceeds from sale of future royalties — Non-cash Kadcyla royalty revenue Non-cash interest expense recognized Liability related to sale of future royalties — ending balance $ $ |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Jun. 30, 2016 | |
Income Taxes | |
Reconciliation of the Company's expected tax benefit, as computed by applying the U.S. federal corporate tax rate to loss before the benefit for income taxes, and actual tax | The difference between the Company’s expected tax benefit, as computed by applying the U.S. federal corporate tax rate of 34% to loss before the benefit for income taxes, and actual tax is reconciled in the following chart (in thousands): Year Ended June 30, 2016 2015 2014 Loss before income tax expense $ $ $ Expected tax benefit at 34% $ $ $ Permanent differences Incentive stock options State tax benefit net of federal benefit Increase in valuation allowance, net Federal research credit Federal orphan drug credit — Expired loss and credit carryforwards Other — — Benefit for income taxes $ — $ — $ — |
Schedule of significant components of deferred tax assets | Significant components of the Company’s deferred tax assets and liabilities as of June 30, 2016 and 2015 are as follows (in thousands): June 30, 2016 2015 Deferred tax assets: Net operating loss carryforwards $ $ Research and development tax credit carryforwards Property and other intangible assets Deferred revenue Stock-based compensation Deferred lease incentive Other liabilities Royalty sale Total deferred tax assets $ $ Deferred tax liabilities: Accounting method change Royalty sale transaction costs Total deferred tax liabilities $ $ Valuation allowance Net deferred tax assets/(liabilities) $ — $ — |
Capital Stock (Tables)
Capital Stock (Tables) | 12 Months Ended |
Jun. 30, 2016 | |
Capital Stock | |
Schedule of options exercisable and their respective weighted average exercise prices per share | The following options and their respective weighted ‑ average exercise prices per share were exercisable at June 30, 2016, 2015 and 2014: Weighted ‑ Exercisable Average (in thousands) Exercise Price June 30, 2016 $ June 30, 2015 $ June 30, 2014 $ |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Jun. 30, 2016 | |
Commitments and Contingencies | |
Minimum rental commitments for the next five fiscal years and thereafter under the non-cancelable operating lease agreements | As of June 30, 2016, the minimum rental commitments, including real estate taxes and other expenses, for the next five fiscal years and thereafter under the non ‑cancelable operating lease agreements discussed above are as follows (in thousands): 2017 $ 2018 2019 2020 2021 Thereafter Total minimum lease payments $ Total minimum rental income from subleases Total minimum lease payments, net $ |
Quarterly Financial Informati26
Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Jun. 30, 2016 | |
Quarterly Financial Information (Unaudited) | |
Schedule of Quarterly Financial Information (Unaudited) | Fiscal Year 2016 First Quarter Second Quarter Third Quarter Fourth Quarter Ended Ended Ended Ended September 30, 2015 December 31, 2015 March 31, 2016 June 30, 2016 (In thousands, except per share data) Revenues: License and milestone fees $ $ $ $ Royalty revenue — — — Non-cash royalty revenue related to the sale of future royalties Research and development support Clinical materials revenue Total revenues Expenses: Research and development General and administrative Total expenses Loss from operations Non-cash interest expense on liability related to sale of future royalty and senior convertible notes Other income (expense), net Net loss $ $ $ $ Basic and diluted net loss per common share $ $ $ $ Fiscal Year 2015 First Quarter Second Quarter Third Quarter Fourth Quarter Ended Ended Ended Ended September 30, 2014 December 31, 2014 March 31, 2015 June 30, 2015 (In thousands, except per share data) Revenues: License and milestone fees $ $ $ $ Royalty revenue Non-cash royalty revenue related to the sale of future royalties — — — Research and development support Clinical materials revenue Total revenues Expenses: Research and development General and administrative Total expenses (Loss) income from operations Non-cash interest expense on liability related to sale of future royalty — — — Other (expense) income, net Net (loss) income $ $ $ $ Basic and diluted net (loss) income per common share $ $ $ $ |
Nature of Business and Plan o27
Nature of Business and Plan of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2013 | |
Nature of Business and Plan of Operations | ||||||||||||
Net loss | $ (45,922) | $ (31,928) | $ (33,227) | $ (33,740) | $ (30,474) | $ (21,618) | $ 13,635 | $ (22,282) | $ (144,817) | $ (60,739) | $ (71,364) | |
Accumulated deficit | (853,687) | (708,870) | (853,687) | (708,870) | ||||||||
Product Revenue | 0 | 0 | 0 | |||||||||
Cash and cash equivalents | $ 245,026 | $ 278,109 | $ 245,026 | $ 278,109 | $ 142,261 | $ 194,960 |
Summary of Significant Accoun28
Summary of Significant Accounting Policies - Revenue (Details) $ in Millions | 1 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2015item | Mar. 31, 2015item | Oct. 31, 2014item | Dec. 31, 2013item | May 31, 2013item | Mar. 31, 2013item | Jun. 30, 2016USD ($)item | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Dec. 31, 2011item | Dec. 31, 2010item | Dec. 31, 2000item | |
Summary of Significant Accounting Policies | ||||||||||||
Number of types of licensing and development agreements with collaborative partners | 2 | |||||||||||
Development and Commercialization License | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Difference between the full cost to manufacture and amounts received from collaborators for preclinical and clinical materials | $ | $ 6.9 | $ 9.2 | $ 2.3 | |||||||||
Number of types of milestone payments under collaborative arrangements | 3 | |||||||||||
Number of quarters in arrear for revenue recognition | 1 | |||||||||||
Development and Commercialization License | Minimum | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Period to earn royalty payments | 10 years | |||||||||||
Development and Commercialization License | Maximum | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Period to earn royalty payments | 12 years | |||||||||||
Development and Commercialization License | Kadcyla | Minimum | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Period to earn royalty payments | 10 years | |||||||||||
Development and Commercialization License | Kadcyla | Maximum | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Period to earn royalty payments | 12 years | |||||||||||
Amgen | Exclusive Development And Commercialization License | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 2 | |||||||||||
Amgen | Exclusive Development And Commercialization License | Oxford BioTherapeutics Ltd Member | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 1 | |||||||||||
Amgen | Development and Commercialization License | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 4 | 1 | 2 | 3 | ||||||||
Bayer | Exclusive Development And Commercialization License | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 1 | |||||||||||
Biotest | Exclusive Development And Commercialization License | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 1 | |||||||||||
CytomX | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 1 | |||||||||||
Lilly | Exclusive Development And Commercialization License | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 3 | |||||||||||
Lilly | Right-to-test agreement | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 3 | |||||||||||
Novartis | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of related targets | 2 | |||||||||||
Novartis | Exclusive Development And Commercialization License | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 5 | |||||||||||
Number of licenses to two related targets | 1 | |||||||||||
Number of related targets | 1 | |||||||||||
Novartis | Development and Commercialization License | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 3 | |||||||||||
Novartis | Right-to-test agreement | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 1 | 6 | ||||||||||
Number of related targets | 2 | |||||||||||
Roche | Exclusive Development And Commercialization License | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 5 | |||||||||||
Sanofi | Exclusive Development And Commercialization License | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 1 | |||||||||||
Number of licenses to multiple individual targets | 1 | |||||||||||
Sanofi | Right-to-test agreement | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 1 | |||||||||||
Takeda | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 1 | |||||||||||
Takeda | Right-to-test agreement | ||||||||||||
Summary of Significant Accounting Policies | ||||||||||||
Number of single-target licenses | 2 |
Summary of Significant Accoun29
Summary of Significant Accounting Policies - Inventory (Details) | 12 Months Ended | ||
Jun. 30, 2016USD ($)item | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | |
Inventory | |||
Raw materials | $ 317,000 | $ 279,000 | |
Work in process | 590,000 | 2,656,000 | |
Total | $ 907,000 | 2,935,000 | |
Number of suppliers | item | 2 | ||
Raw materials inventory write-downs | $ 1,400,000 | 1,400,000 | |
Minimum supply period of raw materials that is not supported by firm, fixed orders and/or projections from collaborators considered to expense inventory | 12 months | ||
Rolling period of firm, fixed orders for conjugate that the company is required to manufacture | 6 months | ||
Rolling period of manufacturing projections for the quantity of conjugate the collaborator expects to need | 12 months | ||
Maximum period of firm, fixed orders and/or projections from collaborators considered for capitalizing inventory | 12 months | ||
Charges to research and development expense related to raw material inventory identified as excess | $ 1,100,000 | $ 1,000,000 | $ 364,000 |
Summary of Significant Accoun30
Summary of Significant Accounting Policies - Acc Liab (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Jun. 30, 2015 |
Other Accrued Liabilities | ||
Accrued contract payments | $ 4,202 | $ 5,830 |
Accrued clinical trial costs | 3,096 | 1,735 |
Accrued professional services | 1,028 | 788 |
Accrued employee benefits | 640 | 567 |
Accrued public reporting charges | 192 | 192 |
Other current accrued liabilities | 555 | 1,329 |
Total | $ 9,713 | $ 10,441 |
Summary of Significant Accoun31
Summary of Significant Accounting Policies - FinInst (Details) | 12 Months Ended | |||
Jun. 30, 2016USD ($)item | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Jun. 30, 2013USD ($) | |
Financial Instruments and Concentration of Credit Risk | ||||
Number of financial institutions in the U.S. in which cash and cash equivalents are primarily maintained | item | 3 | |||
Number of marketable securities held by entity | $ 0 | |||
Cash and Cash Equivalents | ||||
Cash and cash equivalents | 245,026,000 | $ 278,109,000 | $ 142,261,000 | $ 194,960,000 |
Noncash Investing Activities | ||||
Accrued capital expenditures | $ 804,000 |
Summary of Significant Accoun32
Summary of Significant Accounting Policies - Fair Value (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Jun. 30, 2015 |
Fair value hierarchy for the Company's financial assets measured at fair value | ||
Interest rate (as a percent) | 4.50% | |
Recurring basis | ||
Fair value hierarchy for the Company's financial assets measured at fair value | ||
Cash equivalents | $ 219,918 | $ 269,304 |
Recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair value hierarchy for the Company's financial assets measured at fair value | ||
Cash equivalents | $ 219,918 | $ 269,304 |
Convertible Notes | ||
Fair value hierarchy for the Company's financial assets measured at fair value | ||
Interest rate (as a percent) | 4.50% | |
Convertible Notes | Significant Other Observable Inputs (Level 2) | Carrying amount | ||
Fair value hierarchy for the Company's financial assets measured at fair value | ||
Convertible debt fair value | $ 100,000 | |
Convertible Notes | Significant Other Observable Inputs (Level 2) | Estimated fair value | ||
Fair value hierarchy for the Company's financial assets measured at fair value | ||
Convertible debt fair value | $ 91,200 |
Summary of Significant Accoun33
Summary of Significant Accounting Policies - PPE (Details) - USD ($) | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | |
Property and Equipment | |||
(Losses) gains on the sale/disposal of furniture and equipment (in dollars) | $ 21,000 | $ (7,000) | $ (20,000) |
Impairment of long-lived assets | $ 0 | 0 | |
Machinery and equipment | |||
Property and Equipment | |||
Estimated useful lives | 5 years | ||
Computer hardware and software | |||
Property and Equipment | |||
Estimated useful lives | 3 years | ||
Furniture and fixtures | |||
Property and Equipment | |||
Estimated useful lives | 5 years | ||
(Losses) gains on the sale/disposal of furniture and equipment (in dollars) | $ 21,000 | $ (7,000) | $ (20,000) |
Leasehold improvements | Maximum | |||
Property and Equipment | |||
Estimated useful lives | 7 years |
Summary of Significant Accoun34
Summary of Significant Accounting Policies - EPS and SBC (Details) | Nov. 11, 2014shares | Aug. 31, 2016shares | May 31, 2016itemshares | Jan. 31, 2015itemshares | Nov. 30, 2012itemshares | Jun. 30, 2016USD ($)item$ / sharesshares | Jun. 30, 2015USD ($)$ / sharesshares | Jun. 30, 2014USD ($)$ / sharesshares |
Computation of Net Loss per Common Share | ||||||||
Options outstanding to purchase common stock and unvested restricted stock | 11,919,000 | 9,739,000 | 8,486,000 | |||||
Common stock equivalents under treasury stock method for options (in shares) | 735,000 | 770,000 | 1,820,000 | |||||
Shares issuable upon conversion of convertible notes (in shares) | item | 23,878,000 | |||||||
Common stock equivalents under if-converted method for convertible notes (in shares) | 718,000 | |||||||
Additional disclosure for options | ||||||||
Cash received for exercise of stock options | $ | $ 5,161,000 | $ 4,429,000 | $ 9,136,000 | |||||
Stock options | ||||||||
Number of Stock Options | ||||||||
Exercised (in shares) | (555,000) | |||||||
Stock options | Chief Executive Officer | ||||||||
Additional disclosure for options | ||||||||
Stock compensation cost due to modification | $ | $ 3,100,000 | 0 | 0 | |||||
Restricted stock | Officer | ||||||||
Stock-Based Compensation | ||||||||
Vesting period | 3 years | |||||||
Service period | 5 years | |||||||
Number of Restricted Stock | ||||||||
Awarded (in shares) | 117,800 | |||||||
Deferred share units | ||||||||
Additional disclosure for options | ||||||||
Stock compensation expense | $ | $ 380,000 | 389,000 | 433,000 | |||||
2006 Plan | ||||||||
Stock-Based Compensation | ||||||||
Number of employee share-based compensation plans | item | 1 | |||||||
Additional number of shares authorized for issuance | 5,500,000 | |||||||
Common stock authorized for issuance (in shares) | 17,500,000 | |||||||
Additional disclosure for options | ||||||||
Stock compensation expense | $ | $ 21,900,000 | $ 15,300,000 | $ 15,600,000 | |||||
Estimated fair value of unvested employee awards, net of estimated forfeitures | $ | $ 26,600,000 | |||||||
Weighted average vesting period of unvested employee awards | 2 years | |||||||
2006 Plan | Stock options | ||||||||
Weighted-average assumptions used to estimate the fair value of each stock option | ||||||||
Number of group of awards for which expected term is calculated for and applied | item | 1 | |||||||
Dividend (as a percent) | 0.00% | 0.00% | 0.00% | |||||
Volatility (as a percent) | 66.34% | 60.86% | 60.40% | |||||
Risk-free interest rate (as a percent) | 1.80% | 1.84% | 1.74% | |||||
Expected life | 6 years 3 months 18 days | 6 years 3 months 18 days | 6 years 3 months 18 days | |||||
Weighted-average grant date fair values of options granted (in dollars per share) | $ / shares | $ 8.91 | $ 6.04 | $ 10.50 | |||||
Number of Stock Options | ||||||||
Outstanding at the beginning of the period (in shares) | 9,689,000 | |||||||
Granted (in shares) | 3,340,000 | |||||||
Exercised (in shares) | (555,000) | |||||||
Forfeited/Canceled (in shares) | (661,000) | |||||||
Outstanding at the end of the period (in shares) | 11,813,000 | 9,689,000 | ||||||
Vested or unvested and expected to vest at the end of the period (in shares) | 11,475,000 | |||||||
Exercisable at the end of the period (in shares) | 6,453,000 | 5,380,000 | 4,637,000 | |||||
Weighted-Average Exercise Price | ||||||||
Outstanding at the beginning of the period (in dollars per share) | $ / shares | $ 12.49 | |||||||
Granted (in dollars per share) | $ / shares | 14.34 | |||||||
Exercised (in dollars per share) | $ / shares | 9.30 | |||||||
Forfeited/Canceled (in dollars per share) | $ / shares | 14.84 | |||||||
Outstanding at the end of the period (in dollars per share) | $ / shares | 13.03 | $ 12.49 | ||||||
Vested or unvested and expected to vest at the end of the period (in dollars per share) | $ / shares | 13.05 | |||||||
Exercisable at the end of the period (in dollars per share) | $ / shares | $ 12.63 | $ 11.89 | $ 9.79 | |||||
Weighted-Average Remaining Life (in years) | ||||||||
Outstanding at the end of the period | 6 years 9 months 26 days | |||||||
Vested or unvested and expected to vest at the end of the period | 6 years 9 months 4 days | |||||||
Exercisable at the end of the period | 5 years 3 months 18 days | |||||||
Additional disclosure for options | ||||||||
Total fair value of options vested | $ | $ 15,298,000 | $ 16,145,000 | $ 12,535,000 | |||||
Total intrinsic value of options exercised | $ | 3,142,000 | 3,275,000 | 9,961,000 | |||||
Cash received for exercise of stock options | $ | $ 5,161,000 | $ 4,429,000 | $ 9,136,000 | |||||
2006 Plan | Stock options | Maximum | ||||||||
Stock-Based Compensation | ||||||||
Vesting period | 4 years | |||||||
Exercise period | 10 years | |||||||
2006 Plan | Restricted stock | Officer | ||||||||
Stock-Based Compensation | ||||||||
Vesting period | 4 years | 4 years | 4 years | |||||
Number of Restricted Stock | ||||||||
Number of officers | item | 3 | 3 | 3 | |||||
Unvested at the beginning of the period (in shares) | 50,000,000 | |||||||
Awarded (in shares) | 75,000 | 25,000 | 50,000 | 75,000,000 | ||||
Vested (in shares) | (18,750,000) | |||||||
Unvested at the end of the period (in shares) | 106,250,000 | 50,000,000 | ||||||
Weighted-Average Exercise Price | ||||||||
Unvested at the beginning of the period (in dollars per share) | $ / shares | $ 9.23 | |||||||
Awarded (in dollars per share) | $ / shares | 5.65 | |||||||
Vested (in dollars per share) | $ / shares | 10.13 | |||||||
Unvested at the end of the period (in dollars per share) | $ / shares | $ 6.54 | $ 9.23 | ||||||
Former Plan | ||||||||
Number of Stock Options | ||||||||
Granted (in shares) | 1,676,599 |
Summary of Significant Accoun35
Summary of Significant Accounting Policies - Segments (Details) | 12 Months Ended | |||
Jun. 30, 2016USD ($)item | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2015USD ($) | |
Segment Information | ||||
Number of operating segments | item | 1 | |||
Accounting Standards Update 2015-03 | ||||
Recent Accounting Pronouncements | ||||
Deferred financing costs | $ 7,800,000 | |||
Accounting Standards Update 2015-17 | ||||
Recent Accounting Pronouncements | ||||
Reduction in long-term assets and Liabilities, current | $ 843,000 | |||
Bayer | Revenues percentage | Customer concentration | ||||
Segment Information | ||||
Percentages of revenue recognized | 17.00% | |||
Lilly | Revenues percentage | Customer concentration | ||||
Segment Information | ||||
Percentages of revenue recognized | 11.00% | 21.00% | 18.00% | |
Novartis | Revenues percentage | Customer concentration | ||||
Segment Information | ||||
Percentages of revenue recognized | 1.00% | 43.00% | 38.00% | |
Roche | Revenues percentage | Customer concentration | ||||
Segment Information | ||||
Percentages of revenue recognized | 43.00% | 23.00% | 34.00% | |
Takeda | Revenues percentage | Customer concentration | ||||
Segment Information | ||||
Percentages of revenue recognized | 16.00% |
Agreements - Roche (Details)
Agreements - Roche (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | 198 Months Ended | |||||||||||
Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Sep. 30, 2014USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($)item | Dec. 31, 2000USD ($)item | Jun. 30, 2016USD ($) | Dec. 31, 2006USD ($) | |
Collaborative Agreements disclosures | ||||||||||||||
Non-cash royalty revenue related to sale of future royalties | $ 5,944 | $ 7,380 | $ 6,291 | $ 5,684 | $ 5,484 | $ 25,299 | $ 5,484 | |||||||
Royalties on net sales of Kadcyla | $ 195 | $ (23) | $ 5,099 | $ 4,625 | $ 4,166 | 195 | 13,867 | $ 10,346 | ||||||
Development and Commercialization License | Development milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | $ 4,500 | |||||||||||||
Roche | Kadcyla | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Non-cash royalty revenue related to sale of future royalties | 25,300 | 5,500 | ||||||||||||
Royalties on net sales of Kadcyla | $ 13,900 | $ 10,300 | ||||||||||||
Roche | Development and Commercialization License | Kadcyla | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Payments received under collaboration agreement | $ 2,000 | |||||||||||||
Potential milestone payments | 44,000 | |||||||||||||
Roche | Development and Commercialization License | Kadcyla | Development milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Payments received under collaboration agreement | $ 13,500 | |||||||||||||
Potential milestone payments | 13,500 | |||||||||||||
Roche | Development and Commercialization License | Kadcyla | Regulatory milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Payments received under collaboration agreement | 20,500 | |||||||||||||
Potential milestone payments | 5,000 | 5,000 | 30,500 | 5,000 | ||||||||||
Number of milestone payments received | item | 2 | |||||||||||||
Roche | Development and Commercialization License | Kadcyla | Regulatory milestones in Japan | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Payments received under collaboration agreement | $ 5,000 | |||||||||||||
Roche | Development and Commercialization License | Kadcyla | Regulatory milestones in Europe | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Payments received under collaboration agreement | $ 5,000 | |||||||||||||
Roche | Right-to-test agreement | Undisclosed Target | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Payments received under collaboration agreement | 5,000 | |||||||||||||
Potential milestone payments | $ 38,000 | |||||||||||||
Number of undisclosed targets with exclusive licenses | item | 4 | |||||||||||||
License exercise fee | $ 1,000 | |||||||||||||
Term of agreement | 8 years | |||||||||||||
Roche | Right-to-test agreement | Undisclosed Target | Development milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | $ 8,000 | |||||||||||||
Roche | Right-to-test agreement | Undisclosed Target | IND application filed | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | $ 1,000 | $ 1,000 | $ 1,000 | |||||||||||
Roche | Right-to-test agreement | Undisclosed Target | Regulatory milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | 20,000 | |||||||||||||
Roche | Right-to-test agreement | Undisclosed Target | Sales milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | $ 10,000 |
Agreements - Amgen (Details)
Agreements - Amgen (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 198 Months Ended | |||||||||||||||
Feb. 29, 2016item | Dec. 31, 2015item | Sep. 30, 2015USD ($) | Oct. 31, 2013USD ($) | May 31, 2013USD ($)item | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Sep. 30, 2014USD ($) | Jun. 30, 2016USD ($)item | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Dec. 31, 2000USD ($)item | Jun. 30, 2016USD ($) | Dec. 31, 2006USD ($) | |
Collaborative Agreements disclosures | |||||||||||||||||||
Amount of arrangement consideration included in license and milestone fees | $ 76,000 | $ 10,077,000 | $ 10,692,000 | $ 6,070,000 | $ 5,086,000 | $ 5,078,000 | $ 41,417,000 | $ 6,234,000 | $ 26,915,000 | $ 57,815,000 | $ 39,455,000 | ||||||||
Costs related to the research and development services | 38,652,000 | $ 36,094,000 | $ 38,199,000 | $ 35,132,000 | $ 30,437,000 | $ 25,666,000 | $ 27,647,000 | $ 28,018,000 | 148,077,000 | 111,768,000 | 106,958,000 | ||||||||
Development and Commercialization License | Development milestones | |||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||
Potential milestone payments | $ 4,500,000 | ||||||||||||||||||
Amgen | |||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||
Costs related to the research and development services | 15,000 | 62,000 | 179,000 | ||||||||||||||||
Costs related to clinical materials sold | $ 0 | $ 0 | 664,000 | ||||||||||||||||
Amgen | Development and Commercialization License | |||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||
Number of single-target licenses | item | 4 | 1 | 2 | 3 | |||||||||||||||
Fee received per license | $ 500,000 | $ 500,000 | $ 1,000,000 | ||||||||||||||||
Number of licenses terminated | item | 2 | 2 | |||||||||||||||||
Potential milestone payments | $ 34,000,000 | ||||||||||||||||||
Estimated term of development and commercialization license | 25 years | ||||||||||||||||||
Discount rate (as a percent) | 13.00% | ||||||||||||||||||
Remaining arrangement consideration to be recognized as license revenue | $ 430,000 | ||||||||||||||||||
Amount of arrangement consideration included in license and milestone fees | $ 2,200,000 | $ 3,000,000 | |||||||||||||||||
Estimated utilization period after commercialization | 10 years | ||||||||||||||||||
Amgen | Development and Commercialization License | Development milestones | |||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||
Potential milestone payments | $ 9,000,000 | ||||||||||||||||||
Amgen | Development and Commercialization License | IND application filed | |||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||
Potential milestone payments | 1,000,000 | $ 1,000,000 | 1,000,000 | ||||||||||||||||
Amount of arrangement consideration included in license and milestone fees | $ 1,000,000 | ||||||||||||||||||
Amgen | Development and Commercialization License | Phase II clinical trial | |||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||
Potential milestone payments | $ 3,000,000 | $ 3,000,000 | $ 3,000,000 | ||||||||||||||||
Amgen | Development and Commercialization License | Regulatory milestones | |||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||
Potential milestone payments | 20,000,000 | ||||||||||||||||||
Amgen | Development and Commercialization License | Sales milestones | |||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||
Potential milestone payments | $ 5,000,000 |
Agreements - Sanofi (Details)
Agreements - Sanofi (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | 162 Months Ended | ||||||||||||
Oct. 31, 2015USD ($) | Dec. 31, 2013USD ($)item | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Sep. 30, 2014USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Jun. 30, 2016USD ($) | Dec. 31, 2006USD ($) | Dec. 31, 2003USD ($) | |
Collaborative Agreements disclosures | ||||||||||||||||
License and milestone fees | $ 76 | $ 10,077 | $ 10,692 | $ 6,070 | $ 5,086 | $ 5,078 | $ 41,417 | $ 6,234 | $ 26,915 | $ 57,815 | $ 39,455 | |||||
Development and Commercialization License | Development milestones | ||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||
Potential milestone payments | $ 4,500 | |||||||||||||||
Sanofi | Development and Commercialization License | ||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||
Potential milestone payments | $ 21,500 | |||||||||||||||
Payments received under collaboration agreement | $ 20,500 | |||||||||||||||
Sanofi | Development and Commercialization License | Development milestones | ||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||
Potential milestone payments | 7,500 | |||||||||||||||
Payments received under collaboration agreement | 3,000 | |||||||||||||||
Sanofi | Development and Commercialization License | Phase IIb Clinical Trial | ||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||
Potential milestone payments | 3,000 | 3,000 | 3,000 | |||||||||||||
Sanofi | Development and Commercialization License | Phase III Clinical Trial | ||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||
Potential milestone payments | 3,000 | 3,000 | 3,000 | |||||||||||||
Sanofi | Development and Commercialization License | Phase I clinical trial | ||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||
Potential milestone payments | 1,000 | 1,000 | 1,000 | |||||||||||||
Payments received under collaboration agreement | 1,000 | |||||||||||||||
Sanofi | Development and Commercialization License | Regulatory milestones | ||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||
Potential milestone payments | $ 14,000 | |||||||||||||||
Sanofi | Right-to-test agreement | ||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||
Potential milestone payments | $ 30,000 | |||||||||||||||
Fee received per license | $ 2,000 | |||||||||||||||
Number of single-target licenses | item | 1 | |||||||||||||||
License and milestone fees | $ 1,500 | |||||||||||||||
Sanofi | Right-to-test agreement | Development milestones | ||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||
Potential milestone payments | $ 10,000 | |||||||||||||||
Sanofi | Right-to-test agreement | Phase IIb Clinical Trial | ||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||
Potential milestone payments | $ 4,000 | $ 4,000 | $ 4,000 | |||||||||||||
Sanofi | Right-to-test agreement | Phase I clinical trial | ||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||
License and milestone fees | $ 2,000 | |||||||||||||||
Sanofi | Right-to-test agreement | Regulatory milestones | ||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||
Potential milestone payments | $ 20,000 |
Agreements - Biotest (Details)
Agreements - Biotest (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Sep. 30, 2008 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2006 | |
Collaborative Agreements disclosures | |||||||||||||
Costs related to the research and development services | $ 38,652,000 | $ 36,094,000 | $ 38,199,000 | $ 35,132,000 | $ 30,437,000 | $ 25,666,000 | $ 27,647,000 | $ 28,018,000 | $ 148,077,000 | $ 111,768,000 | $ 106,958,000 | ||
Development and Commercialization License | Development milestones | |||||||||||||
Collaborative Agreements disclosures | |||||||||||||
Potential milestone payments | $ 4,500,000 | ||||||||||||
Biotest | |||||||||||||
Collaborative Agreements disclosures | |||||||||||||
Costs related to the research and development services | 160,000 | 309,000 | 305,000 | ||||||||||
Costs related to clinical materials sold | 1,800,000 | $ 3,000,000 | $ 670,000 | ||||||||||
Biotest | Development and Commercialization License | |||||||||||||
Collaborative Agreements disclosures | |||||||||||||
Payments received under collaboration agreement | 1,000,000 | ||||||||||||
Potential milestone payments | 35,500,000 | ||||||||||||
Opt-in-fee payable on exercise of right | 15,000,000 | ||||||||||||
Biotest | Development and Commercialization License | Development milestones | |||||||||||||
Collaborative Agreements disclosures | |||||||||||||
Payments received under collaboration agreement | $ 500,000 | ||||||||||||
Biotest | Development and Commercialization License | Phase IIb Clinical Trial | |||||||||||||
Collaborative Agreements disclosures | |||||||||||||
Potential milestone payments | $ 2,000,000 | $ 2,000,000 | |||||||||||
Biotest | Development and Commercialization License | Regulatory milestones | |||||||||||||
Collaborative Agreements disclosures | |||||||||||||
Potential milestone payments | $ 31,000,000 |
Agreements - Bayer (Details)
Agreements - Bayer (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | 102 Months Ended | |||||||||||
Jan. 31, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2008 | Jun. 30, 2016 | Dec. 31, 2006 | |
Collaborative Agreements disclosures | |||||||||||||||
Amount of arrangement consideration included in license and milestone fees | $ 76 | $ 10,077 | $ 10,692 | $ 6,070 | $ 5,086 | $ 5,078 | $ 41,417 | $ 6,234 | $ 26,915 | $ 57,815 | $ 39,455 | ||||
Development and Commercialization License | Development milestones | |||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||
Potential milestone payments | $ 4,500 | ||||||||||||||
Bayer | Development and Commercialization License | |||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||
Payments received under collaboration agreement | $ 4,000 | $ 13,000 | |||||||||||||
Potential milestone payments | $ 170,500 | ||||||||||||||
Bayer | Development and Commercialization License | Minimum | |||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||
Percentage of royalty payments | 4.00% | ||||||||||||||
Bayer | Development and Commercialization License | Maximum | |||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||
Percentage of royalty payments | 7.00% | ||||||||||||||
Bayer | Development and Commercialization License | Development milestones | |||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||
Potential milestone payments | 6,000 | 6,000 | $ 16,000 | 6,000 | |||||||||||
Bayer | Development and Commercialization License | Phase II clinical trial | |||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||
Potential milestone payments | $ 2,000 | $ 2,000 | $ 2,000 | ||||||||||||
Amount of arrangement consideration included in license and milestone fees | $ 10,000 | ||||||||||||||
Bayer | Development and Commercialization License | Regulatory milestones | |||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||
Potential milestone payments | 44,500 | ||||||||||||||
Bayer | Development and Commercialization License | Sales milestones | |||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||
Potential milestone payments | $ 110,000 |
Agreements - Novartis (Details)
Agreements - Novartis (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 33 Months Ended | |||||||||||||||||
May 31, 2015USD ($) | Jan. 31, 2015USD ($) | Oct. 31, 2014USD ($)item | Nov. 30, 2013USD ($) | Oct. 31, 2013USD ($) | Mar. 31, 2013USD ($)item | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Sep. 30, 2014USD ($) | Jun. 30, 2016USD ($)item | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Jun. 30, 2013USD ($) | Dec. 31, 2010USD ($)item | Jun. 30, 2016USD ($) | Dec. 31, 2006USD ($) | |
Collaborative Agreements disclosures | |||||||||||||||||||||
Amount of arrangement consideration included in license and milestone fees | $ 76,000 | $ 10,077,000 | $ 10,692,000 | $ 6,070,000 | $ 5,086,000 | $ 5,078,000 | $ 41,417,000 | $ 6,234,000 | $ 26,915,000 | $ 57,815,000 | $ 39,455,000 | ||||||||||
Costs related to the research and development services | 38,652,000 | $ 36,094,000 | $ 38,199,000 | $ 35,132,000 | $ 30,437,000 | $ 25,666,000 | $ 27,647,000 | $ 28,018,000 | $ 148,077,000 | 111,768,000 | 106,958,000 | ||||||||||
Development and Commercialization License | Development milestones | |||||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||||
Potential milestone payments | $ 4,500,000 | ||||||||||||||||||||
Novartis | |||||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||||
Number of related targets | item | 2 | ||||||||||||||||||||
Payments received under collaboration agreement | $ 60,200,000 | ||||||||||||||||||||
Costs related to the research and development services | $ 67,000 | 141,000 | 1,400,000 | ||||||||||||||||||
Costs related to clinical materials sold | $ 0 | 644,000 | 1,300,000 | ||||||||||||||||||
Novartis | Right-to-test agreement | |||||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||||
Number of single-target licenses | item | 1 | 6 | |||||||||||||||||||
Number of related targets | item | 2 | ||||||||||||||||||||
Payments received under collaboration agreement | $ 5,000,000 | $ 1,000,000 | $ 45,000,000 | ||||||||||||||||||
Term of agreement | 1 year | 3 years | |||||||||||||||||||
Payments for extension of agreement | 3,500,000 | ||||||||||||||||||||
Payments received under collaboration agreement in connection with amended agreement | 3,500,000 | ||||||||||||||||||||
Novartis | Development and Commercialization License | |||||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||||
Number of single-target licenses | item | 3 | ||||||||||||||||||||
Payments received under collaboration agreement | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 | |||||||||||||||||
Potential milestone payments | $ 199,500,000 | 199,500,000 | 199,500,000 | ||||||||||||||||||
Potential milestone payments under second option | $ 238,000,000 | ||||||||||||||||||||
Estimated utilization period after commercialization | 10 years | ||||||||||||||||||||
Discount rate (as a percent) | 16.00% | ||||||||||||||||||||
Amount of arrangement consideration included in license and milestone fees | $ 25,700,000 | 17,200,000 | $ 11,100,000 | ||||||||||||||||||
Cumulative catch-up amount included in license and milestone fees | $ 1,000,000 | ||||||||||||||||||||
Estimated term of development and commercialization license | 25 years | ||||||||||||||||||||
Novartis | Development and Commercialization License | Development milestones | |||||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||||
Payments received under collaboration agreement | $ 5,000,000 | $ 5,000,000 | 55,000,000 | ||||||||||||||||||
Potential milestone payments | $ 22,500,000 | 22,500,000 | |||||||||||||||||||
Potential milestone payments under second option | 22,500,000 | ||||||||||||||||||||
Novartis | Development and Commercialization License | Phase I clinical trial | |||||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||||
Number of single-target licenses | item | 4 | ||||||||||||||||||||
Potential milestone payments | 5,000,000 | $ 5,000,000 | 5,000,000 | ||||||||||||||||||
Novartis | Development and Commercialization License | Phase II clinical trial | |||||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||||
Number of single-target licenses | item | 2 | ||||||||||||||||||||
Potential milestone payments | $ 7,500,000 | $ 7,500,000 | 7,500,000 | ||||||||||||||||||
Novartis | Development and Commercialization License | Future Technological Improvements | |||||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||||
Payments received under collaboration agreement | 4,500,000 | ||||||||||||||||||||
Novartis | Development and Commercialization License | Research Services | |||||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||||
Payments received under collaboration agreement | $ 710,000 | ||||||||||||||||||||
Novartis | Development and Commercialization License | Regulatory milestones | |||||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||||
Potential milestone payments | 77,000,000 | 77,000,000 | |||||||||||||||||||
Potential milestone payments under second option | 115,500,000 | ||||||||||||||||||||
Novartis | Development and Commercialization License | Sales milestones | |||||||||||||||||||||
Collaborative Agreements disclosures | |||||||||||||||||||||
Potential milestone payments | 100,000,000 | $ 100,000,000 | |||||||||||||||||||
Potential milestone payments under second option | $ 100,000,000 |
Agreements - Lily (Details)
Agreements - Lily (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 55 Months Ended | 66 Months Ended | |||||||||||||
Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Aug. 31, 2013USD ($) | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Sep. 30, 2014USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Dec. 31, 2011USD ($)item | Jun. 30, 2016USD ($) | Jun. 30, 2016USD ($) | Dec. 31, 2006USD ($) | |
Collaborative Agreements disclosures | ||||||||||||||||||
Amount of arrangement consideration included in license and milestone fees | $ 76,000 | $ 10,077,000 | $ 10,692,000 | $ 6,070,000 | $ 5,086,000 | $ 5,078,000 | $ 41,417,000 | $ 6,234,000 | $ 26,915,000 | $ 57,815,000 | $ 39,455,000 | |||||||
Costs related to the research and development services | 38,652,000 | $ 36,094,000 | $ 38,199,000 | $ 35,132,000 | $ 30,437,000 | $ 25,666,000 | $ 27,647,000 | $ 28,018,000 | 148,077,000 | 111,768,000 | 106,958,000 | |||||||
Development and Commercialization License | Development milestones | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Potential milestone payments | $ 4,500,000 | |||||||||||||||||
Lilly | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Payments received under collaboration agreement | $ 28,200,000 | |||||||||||||||||
Costs related to the research and development services | 182,000 | 499,000 | 1,200,000 | |||||||||||||||
Costs related to clinical materials sold | 1,100,000 | 1,100,000 | $ 26,000 | |||||||||||||||
Lilly | Right-to-test agreement | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Number of development and commercialization licenses taken | item | 3 | |||||||||||||||||
Payments received under collaboration agreement | $ 20,000,000 | |||||||||||||||||
License exercise fee, per license | 2,000,000 | |||||||||||||||||
Lilly | Development and Commercialization License | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Payments received under collaboration agreement | $ 2,000,000 | $ 2,000,000 | $ 23,500,000 | |||||||||||||||
Potential milestone payments | $ 199,000,000 | |||||||||||||||||
Estimated utilization period after commercialization | 10 years | |||||||||||||||||
Discount rate (as a percent) | 16.00% | |||||||||||||||||
Amount of arrangement consideration included in license and milestone fees | $ 7,800,000 | $ 15,600,000 | ||||||||||||||||
Estimated term of development and commercialization license | 25 years | |||||||||||||||||
Lilly | Development and Commercialization License | Phase I clinical trial | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Potential milestone payments | 5,000,000 | 5,000,000 | 5,000,000 | 5,000,000 | ||||||||||||||
Amount of arrangement consideration included in license and milestone fees | 5,000,000 | |||||||||||||||||
Lilly | Development and Commercialization License | Phase II clinical trial | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Potential milestone payments | $ 9,000,000 | $ 9,000,000 | $ 9,000,000 | 9,000,000 | ||||||||||||||
Lilly | Development and Commercialization License | Future Technological Improvements | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Payments received under collaboration agreement | 600,000 | |||||||||||||||||
Lilly | Development and Commercialization License | Research Services | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Payments received under collaboration agreement | 3,300,000 | |||||||||||||||||
Lilly | Development and Commercialization License | Regulatory milestones | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Potential milestone payments | $ 70,000,000 | |||||||||||||||||
Lilly | Development and Commercialization License | Sales milestones | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Payments received under collaboration agreement | $ 800,000 | |||||||||||||||||
Potential milestone payments | 100,000,000 | |||||||||||||||||
Lilly | No exercise fee | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Potential milestone payments | $ 200,500,000 | |||||||||||||||||
Lilly | No exercise fee | Development milestones | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Number of development and commercialization licenses taken | item | 1 | |||||||||||||||||
Potential milestone payments | $ 30,500,000 | |||||||||||||||||
Lilly | Exercise fee | Development milestones | ||||||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||||||
Number of development and commercialization licenses taken | item | 2 | |||||||||||||||||
Potential milestone payments | $ 29,000,000 |
Agreements - CytomX (Details)
Agreements - CytomX (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 30 Months Ended | ||||||||||
Jan. 31, 2014 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2016 | Dec. 31, 2006 | |
Collaborative Agreements disclosures | ||||||||||||||
Long-term deferred revenue | $ 19,288,000 | $ 40,855,000 | $ 19,288,000 | $ 40,855,000 | $ 19,288,000 | |||||||||
Deferred revenue, net of current portion | 19,288,000 | 40,855,000 | 19,288,000 | 40,855,000 | 19,288,000 | |||||||||
Costs related to the research and development services | 38,652,000 | $ 36,094,000 | $ 38,199,000 | $ 35,132,000 | $ 30,437,000 | $ 25,666,000 | $ 27,647,000 | $ 28,018,000 | 148,077,000 | 111,768,000 | $ 106,958,000 | |||
Development and Commercialization License | Development milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | $ 4,500,000 | |||||||||||||
CytomX | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Costs related to the research and development services | 868,000 | $ 130,000 | 0 | |||||||||||
CytomX | Right-to-test agreement | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | $ 160,000,000 | |||||||||||||
Potential milestone payments to be paid | $ 80,000,000 | |||||||||||||
Estimated utilization period after commercialization | 10 years | |||||||||||||
Discount rate (as a percent) | 13.00% | |||||||||||||
Value of collaborators licenses | 13,100,000 | 13,100,000 | 13,100,000 | |||||||||||
Estimated term of development and commercialization license | 25 years | |||||||||||||
Fair value of consideration for services received | $ 13,100,000 | |||||||||||||
CytomX | Right-to-test agreement | Development milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | 10,000,000 | |||||||||||||
Potential milestone payments to be paid | 7,000,000 | |||||||||||||
Fair value of consideration for services provided | 12,700,000 | |||||||||||||
CytomX | Right-to-test agreement | Phase I clinical trial | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | 1,000,000 | 1,000,000 | 1,000,000 | |||||||||||
Potential milestone payments to be paid | 1,000,000 | 1,000,000 | 1,000,000 | |||||||||||
CytomX | Right-to-test agreement | Future Technological Improvements | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Value of collaborators licenses | 13,000,000 | 13,000,000 | 13,000,000 | |||||||||||
Fair value of consideration for services provided | 350,000 | |||||||||||||
CytomX | Right-to-test agreement | Research Services | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Value of collaborators licenses | $ 140,000 | $ 140,000 | 140,000 | |||||||||||
Fair value of consideration for services provided | $ 140,000 | |||||||||||||
Fair value of consideration for services received | 310,000 | $ 12,800,000 | ||||||||||||
CytomX | Right-to-test agreement | Regulatory milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | 50,000,000 | |||||||||||||
Potential milestone payments to be paid | 23,000,000 | |||||||||||||
CytomX | Right-to-test agreement | Sales milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | 100,000,000 | |||||||||||||
Potential milestone payments to be paid | $ 50,000,000 |
Agreements - Takeda (Details)
Agreements - Takeda (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 16 Months Ended | ||||||||||
Mar. 31, 2015USD ($)item | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Sep. 30, 2014USD ($) | Jun. 30, 2016USD ($)item | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Jun. 30, 2016USD ($) | Dec. 31, 2006USD ($) | |
Collaborative Agreements disclosures | ||||||||||||||
Amount of arrangement consideration included in license and milestone fees | $ 76,000 | $ 10,077,000 | $ 10,692,000 | $ 6,070,000 | $ 5,086,000 | $ 5,078,000 | $ 41,417,000 | $ 6,234,000 | $ 26,915,000 | $ 57,815,000 | $ 39,455,000 | |||
Costs related to the research and development services | 38,652,000 | $ 36,094,000 | $ 38,199,000 | $ 35,132,000 | $ 30,437,000 | 25,666,000 | $ 27,647,000 | $ 28,018,000 | $ 148,077,000 | 111,768,000 | 106,958,000 | |||
Development and Commercialization License | Development milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | $ 4,500,000 | |||||||||||||
Takeda | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Number of single-target licenses | item | 1 | |||||||||||||
Costs related to the research and development services | $ 469,000 | $ 113,000 | $ 0 | |||||||||||
Takeda | Right-to-test agreement | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Number of single-target licenses | item | 2 | |||||||||||||
Term of agreement | 3 years | |||||||||||||
Term of extension of the agreement | 1 year | |||||||||||||
Potential payments to extend the agreement term | $ 4,000,000 | |||||||||||||
Potential payment to expand agreement scope | 8,000,000 | |||||||||||||
Payments received under collaboration agreement | 20,000,000 | $ 31,400,000 | ||||||||||||
Potential milestone payments | $ 210,000,000 | 210,000,000 | ||||||||||||
Additional term of extension of the agreement | 2 years | |||||||||||||
Estimated utilization period after commercialization | 10 years | |||||||||||||
Discount rate (as a percent) | 13.00% | |||||||||||||
Estimated term of development and commercialization license | 25 years | |||||||||||||
Remaining arrangement consideration to be recognized as license revenue | 17,300,000 | 17,300,000 | 17,300,000 | |||||||||||
Takeda | Right-to-test agreement | Development milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Payments received under collaboration agreement | 25,900,000 | |||||||||||||
Potential milestone payments | $ 30,000,000 | 30,000,000 | ||||||||||||
Takeda | Right-to-test agreement | Phase I clinical trial | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | $ 5,000,000 | 5,000,000 | 5,000,000 | |||||||||||
Takeda | Right-to-test agreement | Regulatory milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | 85,000,000 | 85,000,000 | ||||||||||||
Takeda | Right-to-test agreement | Sales milestones | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Potential milestone payments | $ 95,000,000 | $ 95,000,000 | ||||||||||||
Takeda | Right-to-test agreement | Future Technological Improvements | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Payments received under collaboration agreement | 2,100,000 | |||||||||||||
Takeda | Right-to-test agreement | Research Services | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Payments received under collaboration agreement | $ 3,400,000 | |||||||||||||
Takeda | Development and Commercialization License | ||||||||||||||
Collaborative Agreements disclosures | ||||||||||||||
Amount of arrangement consideration included in license and milestone fees | $ 8,600,000 |
Agreements - Janssen (Details)
Agreements - Janssen (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2004 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | |
Collaborative Agreements disclosures | ||||||||||||
License and milestone fees | $ 76,000 | $ 10,077,000 | $ 10,692,000 | $ 6,070,000 | $ 5,086,000 | $ 5,078,000 | $ 41,417,000 | $ 6,234,000 | $ 26,915,000 | $ 57,815,000 | $ 39,455,000 | |
Janssen | Development and Commercialization License | ||||||||||||
Collaborative Agreements disclosures | ||||||||||||
License and milestone fees | $ 241,000 | |||||||||||
Payments received under collaboration agreement | $ 1,000,000 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | |
Property and Equipment | |||
Property and equipment, gross | $ 73,307,000 | $ 63,301,000 | |
Less accumulated depreciation | (50,603,000) | (47,047,000) | |
Property and equipment, net | 22,704,000 | 16,254,000 | |
Depreciation expense | 5,327,000 | 5,513,000 | $ 4,598,000 |
Leasehold improvements | |||
Property and Equipment | |||
Property and equipment, gross | 34,743,000 | 32,355,000 | |
Machinery and equipment | |||
Property and Equipment | |||
Property and equipment, gross | 24,324,000 | 18,398,000 | |
Computer hardware and software | |||
Property and Equipment | |||
Property and equipment, gross | 8,277,000 | 6,897,000 | |
Furniture and fixtures | |||
Property and Equipment | |||
Property and equipment, gross | 3,636,000 | 3,290,000 | |
Assets under construction | |||
Property and Equipment | |||
Property and equipment, gross | 2,327,000 | 2,361,000 | |
Equipment under capital leases | |||
Property and Equipment | |||
Less accumulated depreciation | (414,000) | (190,000) | |
Property and equipment, net | $ 876,000 | $ 724,000 |
Convertible 4.5% Senior Notes (
Convertible 4.5% Senior Notes (Details) | 1 Months Ended | 12 Months Ended |
Jun. 30, 2016USD ($)item$ / shares | Jun. 30, 2016USD ($)$ / shares | |
Convertible debt | ||
Interest rate (as a percent) | 4.50% | 4.50% |
Proceeds from issuance of debt | $ 96,608,000 | |
Issuance of debt transaction costs | $ 3,392,000 | |
Convertible Notes | ||
Convertible debt | ||
Interest rate (as a percent) | 4.50% | 4.50% |
Principal amount of debt | $ 100,000,000 | $ 100,000,000 |
Proceeds from issuance of debt | 96,600,000 | |
Issuance of debt transaction costs | 3,400,000 | |
Interest expense | 138,000 | |
Principal amount of debt for conversion calculations | $ 1,000 | $ 1,000 |
Ratio issued upon conversion | 238.7775 | |
Initial conversion price (in dollars per share) | $ / shares | $ 4.19 | $ 4.19 |
Principal amount of notes to be repurchased under certain conditions (as a percent) | 100 | |
Principal amount of notes to be repurchased upon default (as a percent) | 100 | |
Additional interest for reporting requirement failure (as a percent) | 0.5 | |
Default cure period | 90 days | |
Additional interest for restricted event (as a percent) | 0.5 | |
Number of additional interest rate percentage penalty circumstances | item | 2 | |
Maximum additional interest rate (as a percent) | 0.5 |
Liability Related to Sale of 48
Liability Related to Sale of Future Royalties (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | 15 Months Ended | |||||||||
Apr. 30, 2015 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2016 | |
Liability Related to Sale of Future Royalties | |||||||||||||
Royalty revenue | $ 195 | $ (23) | $ 5,099 | $ 4,625 | $ 4,166 | $ 195 | $ 13,867 | $ 10,346 | |||||
Transaction costs for royalty agreements | 5,865 | ||||||||||||
Movement in Deferred Revenue [Roll Forward] | |||||||||||||
Proceeds from sale of future royalties | 194,135 | ||||||||||||
Non-cash Kadcyla royalty revenue | $ (5,944) | $ (7,380) | (6,291) | $ (5,684) | (5,484) | (25,299) | (5,484) | ||||||
Non-cash interest expense on liability related to sale of future royalties and convertible senior notes | 4,956 | $ 4,972 | $ 5,059 | 5,143 | 5,437 | 20,130 | 5,437 | ||||||
Kadcyla | |||||||||||||
Liability Related to Sale of Future Royalties | |||||||||||||
Percentage of royalty payments if applicable threshold is met | 85.00% | ||||||||||||
Kadcyla | IRH | |||||||||||||
Liability Related to Sale of Future Royalties | |||||||||||||
Percentage of royalty payments | 100.00% | ||||||||||||
Royalty revenue | $ 235,000 | ||||||||||||
Royalties on net sales of Kadcyla when royalties to the purchaser reach a specified milestone | $ 260,000 | ||||||||||||
Percentage of royalty payments if applicable threshold is met | 15.00% | ||||||||||||
Transaction costs for royalty agreements | $ 5,900 | ||||||||||||
Movement in Deferred Revenue [Roll Forward] | |||||||||||||
Liability related to sale of future royalties — beginning balance | $ 199,662 | 199,662 | |||||||||||
Proceeds from sale of future royalties | $ 200,000 | ||||||||||||
Non-cash Kadcyla royalty revenue | (25,299) | (30,783) | |||||||||||
Non-cash interest expense on liability related to sale of future royalties and convertible senior notes | 19,009 | 24,155 | |||||||||||
Liability related to sale of future royalties — ending balance | $ 193,372 | $ 199,662 | $ 193,372 | $ 199,662 | $ 193,372 | ||||||||
Effective annual interest rate | 9.60% |
Income Taxes - Expense (Details
Income Taxes - Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | |
Reconciliation of the expected statutory tax benefit to the actual income taxes | |||
U.S. federal corporate tax rate (as a percent) | 34.00% | 34.00% | 34.00% |
Loss before income tax expense | $ (144,817) | $ (60,739) | $ (71,364) |
Expected tax benefit at 34% | (49,238) | (20,651) | (24,264) |
Permanent differences | 345 | 818 | 215 |
Incentive stock options | 2,501 | 1,948 | 1,738 |
State tax benefit net of federal benefit | (7,954) | (3,252) | (4,062) |
Increase in valuation allowance, net | 62,505 | 27,940 | 26,011 |
Federal research credit | (4,109) | (1,407) | (1,002) |
Federal orphan drug credit | (4,241) | (5,471) | |
Expired loss and credit carryforwards | 184 | $ 75 | $ 1,364 |
Other | $ 7 |
Income Taxes - Carryforward (De
Income Taxes - Carryforward (Details) $ in Millions | Jun. 30, 2016USD ($) |
Research | |
Carryforward | |
Federal and state carryforwards | $ 40.4 |
Federal | |
Carryforward | |
Operating loss carryforward | 377.9 |
Operating loss carryforward related to deductions from the exercise of stock options | 27 |
State | |
Carryforward | |
Operating loss carryforward | 214 |
Operating loss carryforward related to deductions from the exercise of stock options | $ 20.5 |
Income Taxes - Deferred (Detail
Income Taxes - Deferred (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 139,791 | $ 89,362 |
Research and development tax credit carryforwards | 36,879 | 25,131 |
Property and other intangible assets | 2,395 | 2,532 |
Deferred revenue | 12,911 | 16,179 |
Stock-based compensation | 16,033 | 11,379 |
Deferred lease incentive | 4,356 | 4,279 |
Other liabilities | 3,726 | 3,177 |
Royalty sale | 75,956 | 78,427 |
Total deferred tax assets | 292,047 | 230,466 |
Deferred tax liabilities: | ||
Accounting method change | (492) | (983) |
Royalty sale transaction costs | (1,757) | (2,190) |
Total deferred tax liabilities | 2,249 | 3,173 |
Valuation allowance | $ (289,798) | $ (227,293) |
Income taxes, additional disclosures | ||
Minimum increase in the ownership of certain shareholders or public groups in the stock of a corporation for an ownership change as defined by Section 382 (as a percent) | 50.00% | |
Period over which increase in ownership of certain shareholders or public groups in the stock of a corporation for an ownership change as defined by Section 382 | 3 years |
Capital Stock (Details)
Capital Stock (Details) - USD ($) | Nov. 12, 2013 | Sep. 22, 2010 | Nov. 11, 2009 | Sep. 16, 2009 | Nov. 30, 2013 | Sep. 30, 2006 | Jun. 30, 2004 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | Nov. 30, 2001 |
Stock-based compensation disclosure | |||||||||||
Aggregate number of common shares reserved for future issuance | 15,500,000 | ||||||||||
Proceeds from stock options exercised | $ 5,161,000 | $ 4,429,000 | $ 9,136,000 | ||||||||
Stock options | |||||||||||
Stock-based compensation disclosure | |||||||||||
Options exercised (in shares) | 555,000 | ||||||||||
Exercise price (in dollars per share) | $ 3.19 | ||||||||||
Exercise price (in dollars per share) | $ 17 | ||||||||||
Deferred share units | |||||||||||
Stock-based compensation disclosure | |||||||||||
Compensation expense | $ 380,000 | 389,000 | 433,000 | ||||||||
2006 Plan | |||||||||||
Stock-based compensation disclosure | |||||||||||
Compensation expense | $ 21,900,000 | 15,300,000 | 15,600,000 | ||||||||
2006 Plan | Stock options | |||||||||||
Stock-based compensation disclosure | |||||||||||
Options exercised (in shares) | 555,000 | ||||||||||
Proceeds from stock options exercised | $ 5,161,000 | $ 4,429,000 | $ 9,136,000 | ||||||||
Exercisable at the end of the period (in shares) | 6,453,000 | 5,380,000 | 4,637,000 | ||||||||
Weighted-Average Exercise Price (in dollars per share) | $ 12.63 | $ 11.89 | $ 9.79 | ||||||||
Stock options granted to directors (in shares) | 3,340,000 | ||||||||||
2001 Director Plan | |||||||||||
Stock-based compensation disclosure | |||||||||||
Aggregate number of common shares reserved for future issuance | 50,000 | ||||||||||
2001 Director Plan | Deferred share units | |||||||||||
Stock-based compensation disclosure | |||||||||||
Compensation expense | $ (72,000) | $ 16,000 | $ (30,000) | ||||||||
Stock units outstanding (in shares) | 6,000 | 6,000 | 6,000 | ||||||||
Stock units issued (in shares) | 0 | 0 | 0 | ||||||||
2004 Director Plan | Deferred share units | |||||||||||
Stock-based compensation disclosure | |||||||||||
Monthly vesting rights (as a percent) | 8.30% | ||||||||||
Vesting period | 3 years | ||||||||||
Compensation Policy for Non-Employee Directors | Stock options | |||||||||||
Stock-based compensation disclosure | |||||||||||
Grant date fair value | $ 30,000 | ||||||||||
Stock options granted to directors (in shares) | 80,000 | 80,000 | 80,000 | ||||||||
Compensation Policy for Non-Employee Directors | Deferred share units | |||||||||||
Stock-based compensation disclosure | |||||||||||
Compensation expense | $ 380,000 | $ 389,000 | $ 433,000 | ||||||||
Stock units issued (in shares) | 43,615 | 41,000 | 31,000 | 28,000 | |||||||
Vesting period | 1 year | 1 year | |||||||||
Common stock issued when a director ceases to be a member (in shares) | 1 | ||||||||||
Stock units previously granted (in shares) | 12,000 | 15,000 | 19,000 | ||||||||
Non-employee directors-initial grant | Deferred share units | |||||||||||
Stock-based compensation disclosure | |||||||||||
Vesting period | 3 years | ||||||||||
Grant date fair value | $ 65,000 | ||||||||||
Non-employee directors-first anniversary | Deferred share units | |||||||||||
Stock-based compensation disclosure | |||||||||||
Grant date fair value | $ 30,000 | ||||||||||
Non-employee directors-after year one | Deferred share units | |||||||||||
Stock-based compensation disclosure | |||||||||||
Vesting period | 1 year | ||||||||||
Grant date fair value | $ 30,000 |
Commitments and Contingencies53
Commitments and Contingencies (Details) | 1 Months Ended | 12 Months Ended | |||||||||
Jul. 31, 2013 | Jun. 30, 2016USD ($)item | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Jun. 30, 2016GBP (£)ft² | Jun. 30, 2016USD ($)ft² | Feb. 29, 2016USD ($)ft² | Dec. 31, 2015USD ($) | Apr. 30, 2014USD ($) | Dec. 31, 2013USD ($) | Apr. 30, 2013ft² | |
Operating leases | |||||||||||
Construction allowance | $ 6,301,000 | $ 6,236,000 | |||||||||
Facilities rent expense, net of sublease income | $ 6,500,000 | $ 6,000,000 | $ 5,400,000 | ||||||||
Minimum rental commitments under the non-cancelable operating lease agreements | |||||||||||
2,017 | 7,902,000 | ||||||||||
2,018 | 8,056,000 | ||||||||||
2,019 | 7,258,000 | ||||||||||
2,020 | 7,254,000 | ||||||||||
2,021 | 7,302,000 | ||||||||||
Thereafter | 34,252,000 | ||||||||||
Total minimum lease payments | 72,024,000 | ||||||||||
Total minimum rental payments from sublease | (250,000) | ||||||||||
Total minimum lease payments, net | 71,774,000 | ||||||||||
Obligations under capital leases | $ 0 | ||||||||||
Collaborations and Licenses | |||||||||||
Potential milestone payable | 162,000,000 | ||||||||||
Amount reimbursable by a third party | $ 1,400,000 | ||||||||||
Obligation to make payment to vendor for certain contractual services | £ | £ 300,000 | ||||||||||
830 Winter Street, Waltham, MA | |||||||||||
Operating leases | |||||||||||
Area of space leased (in square feet) | ft² | 110,000 | 110,000 | |||||||||
Number of additional terms for which lease agreement can be extended | item | 2 | ||||||||||
Lease term extension period | 5 years | ||||||||||
Construction allowance | $ 196,000 | $ 1,100,000 | $ 746,000 | ||||||||
930 Winter Street, Walham, MA | |||||||||||
Operating leases | |||||||||||
Area of space leased (in square feet) | ft² | 10,281 | ||||||||||
Construction allowance | $ 617,000 | ||||||||||
333 Providence Hwy, Norwood MA | |||||||||||
Operating leases | |||||||||||
Area of space leased (in square feet) | ft² | 43,850 | 43,850 | |||||||||
Lease term extension period | 5 years | ||||||||||
100 River Ridge Drive, Norwood, MA | |||||||||||
Operating leases | |||||||||||
Area of space leased (in square feet) | ft² | 7,507 | ||||||||||
Lease term extension period | 5 years | ||||||||||
Lease term period | 5 years 2 months |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | |
Employee Benefit Plans | |||
Maximum employees' contribution (as a percent) | 100.00% | ||
Matching contribution of first 6% of eligible employees' contributions (as a percent) | 50.00% | ||
Percentage of eligible employees' contributions matched by the company | 6.00% | ||
Company's contribution | $ 1,100,000 | $ 875,000 | $ 710,000 |
Quarterly Financial Informati55
Quarterly Financial Information (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2014 | |
Quarterly Financial Information (Unaudited) | |||||||||||
License and milestone fees | $ 76 | $ 10,077 | $ 10,692 | $ 6,070 | $ 5,086 | $ 5,078 | $ 41,417 | $ 6,234 | $ 26,915 | $ 57,815 | $ 39,455 |
Royalty revenue | 195 | (23) | 5,099 | 4,625 | 4,166 | 195 | 13,867 | 10,346 | |||
Non-cash royalty revenue related to the sale of future royalties | 5,944 | 7,380 | 6,291 | 5,684 | 5,484 | 25,299 | 5,484 | ||||
Research and development support | 1,335 | 1,059 | 848 | 772 | 708 | 532 | 832 | 776 | 4,014 | 2,848 | 7,187 |
Clinical materials revenue | 53 | 1,198 | 3 | 2,325 | 1,356 | 718 | 1,426 | 2,027 | 3,579 | 5,527 | 2,908 |
Total revenues | 7,408 | 19,714 | 18,029 | 14,851 | 12,611 | 11,427 | 48,300 | 13,203 | 60,002 | 85,541 | 59,896 |
Operating Expenses: | |||||||||||
Research and development | 38,652 | 36,094 | 38,199 | 35,132 | 30,437 | 25,666 | 27,647 | 28,018 | 148,077 | 111,768 | 106,958 |
General and administrative | 9,298 | 11,235 | 8,054 | 8,329 | 7,261 | 7,000 | 6,872 | 7,095 | 36,916 | 28,228 | 24,469 |
Total operating expenses | 47,950 | 47,329 | 46,253 | 43,461 | 37,698 | 32,666 | 34,519 | 35,113 | 184,993 | 139,996 | 131,427 |
(Loss) income from operations | (40,542) | (27,615) | (28,224) | (28,610) | (25,087) | (21,239) | 13,781 | (21,910) | (124,991) | (54,455) | (71,531) |
Non-cash interest expense on liability related to the sale of future royalties and convertible senior notes | (4,956) | (4,972) | (5,059) | (5,143) | (5,437) | (20,130) | (5,437) | ||||
Other (expense) income, net | (424) | 659 | 56 | 13 | 50 | (379) | (146) | (372) | |||
Net (loss) income | $ (45,922) | $ (31,928) | $ (33,227) | $ (33,740) | $ (30,474) | $ (21,618) | $ 13,635 | $ (22,282) | $ (144,817) | $ (60,739) | $ (71,364) |
Basic and diluted net (loss) income per common share (in dollars per share) | $ (0.53) | $ (0.37) | $ (0.38) | $ (0.39) | $ (0.35) | $ (0.25) | $ 0.16 | $ (0.26) | $ (1.67) | $ (0.71) | $ (0.83) |