Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Mar. 31, 2016 | Apr. 28, 2016 | |
Document and Entity Information | ||
Entity Registrant Name | IMMUNOGEN INC | |
Entity Central Index Key | 855,654 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --06-30 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 87,076,978 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2016 | Jun. 30, 2015 |
ASSETS | ||
Cash and cash equivalents | $ 182,913 | $ 278,109 |
Accounts receivable | 104 | 5,088 |
Unbilled revenue | 1,027 | 714 |
Inventory | 908 | 2,935 |
Current portion of deferred financing costs | 1,018 | 1,159 |
Prepaid and other current assets | 7,334 | 4,175 |
Total current assets | 193,304 | 292,180 |
Property and equipment, net of accumulated depreciation | 22,404 | 16,254 |
Deferred financing costs, net of current portion | 3,714 | 4,415 |
Other assets | 2,925 | 974 |
Total assets | 222,347 | 313,823 |
LIABILITIES AND SHAREHOLDERS' EQUITY | ||
Accounts payable | 10,100 | 8,138 |
Accrued compensation | 6,589 | 8,346 |
Other accrued liabilities | 9,150 | 10,441 |
Current portion of deferred lease incentive | 651 | 646 |
Current portion of liability related to the sale of future royalties | 13,001 | 7,906 |
Current portion of deferred revenue | 339 | 333 |
Total current liabilities | 39,830 | 35,810 |
Deferred lease incentive, net of current portion | 5,836 | 6,301 |
Deferred revenue, net of current portion | 32,015 | 40,855 |
Liability related to the sale of future royalties, net of current portion | 181,636 | 191,756 |
Other long-term liabilities | 4,173 | 3,997 |
Total liabilities | $ 263,490 | $ 278,719 |
Commitments and contingencies (Note E) | ||
Shareholders' 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 87,000 and 86,579 shares as of March 31, 2015 and June 30, 2015, respectively | $ 871 | $ 866 |
Additional paid-in capital | 765,751 | 743,108 |
Accumulated deficit | (807,765) | (708,870) |
Total shareholders' equity | (41,143) | 35,104 |
Total liabilities and shareholders' equity | $ 222,347 | $ 313,823 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands | Mar. 31, 2016 | Jun. 30, 2015 |
CONSOLIDATED BALANCE SHEETS | ||
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 | 87,077 | 86,579 |
Common stock, outstanding shares | 87,077 | 86,579 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2016 | Mar. 31, 2015 | Mar. 31, 2016 | Mar. 31, 2015 | |
Revenues: | ||||
License and milestone fees | $ 10,077 | $ 5,078 | $ 26,839 | $ 52,729 |
Royalty revenue | 5,099 | 195 | 13,890 | |
Non-cash royalty revenue related to the sale of future royalties | 7,380 | 19,355 | ||
Research and development support | 1,059 | 532 | 2,679 | 2,140 |
Clinical materials revenue | 1,198 | 718 | 3,526 | 4,171 |
Total revenues | 19,714 | 11,427 | 52,594 | 72,930 |
Operating Expenses: | ||||
Research and development | 36,094 | 25,666 | 109,425 | 81,331 |
General and administrative | 11,235 | 7,000 | 27,618 | 20,967 |
Total operating expenses | 47,329 | 32,666 | 137,043 | 102,298 |
(Loss) income from operations | (27,615) | (21,239) | (84,449) | (29,368) |
Investment income, net | 108 | 14 | 219 | 36 |
Non-cash interest expense on liability related to the sale of future royalties | (4,972) | (15,174) | ||
Other income (expense), net | 551 | (393) | 509 | (933) |
Net (loss) income | $ (31,928) | $ (21,618) | $ (98,895) | $ (30,265) |
Basic and diluted net (loss) income per common share (in dollars per share) | $ (0.37) | $ (0.25) | $ (1.14) | $ (0.35) |
Basic weighted average common shares outstanding (in shares) | 87,035 | 86,080 | 86,948 | 85,962 |
Total comprehensive (loss) income | $ (31,928) | $ (21,618) | $ (98,895) | $ (30,265) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (98,895) | $ (30,265) |
Adjustments to reconcile net loss to net cash used for operating activities: | ||
Non-cash royalty revenue related to sale of future royalties | (19,355) | |
Non-cash interest expense on liability related to sale of future royalties | 15,174 | |
Depreciation and amortization | 3,822 | 4,231 |
Gain on sale/disposal of fixed assets | (29) | (7) |
Stock and deferred share unit compensation | 17,668 | 12,804 |
Deferred rent | 97 | 161 |
Change in operating assets and liabilities: | ||
Accounts receivable | 4,984 | 1,142 |
Unbilled revenue | (313) | 793 |
Inventory | 2,027 | 248 |
Prepaid and other current assets | (3,159) | (467) |
Other assets | (1,951) | 170 |
Accounts payable | 796 | 1,503 |
Accrued compensation | (1,757) | 306 |
Other accrued liabilities | (1,844) | 639 |
Deferred revenue | (8,834) | (19,446) |
Proceeds from landlord for tenant improvements | 1,350 | |
Net cash used for operating activities | (91,569) | (26,838) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (8,606) | (4,506) |
Payments for transaction costs related to sale of future royalties | (522) | |
Net cash used for investing activities | (8,606) | (5,028) |
Cash flows from financing activities: | ||
Proceeds from stock options exercised | 4,979 | 1,432 |
Net cash provided by financing activities | 4,979 | 1,432 |
Net change in cash and cash equivalents | (95,196) | (30,434) |
Cash and cash equivalents, beginning balance | 278,109 | 142,261 |
Cash and cash equivalents, ending balance | $ 182,913 | $ 111,827 |
Nature of Business and Plan of
Nature of Business and Plan of Operations | 9 Months Ended |
Mar. 31, 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 $98.9 million during the nine months ended March 31, 2016, and has an accumulated deficit of $807.8 million as of March 31, 2016. The Company has primarily funded these losses through payments received from its collaborations and equity financings. To date, the Company has no product revenue and management expects operating losses to continue for the foreseeable future. At March 31, 2016, the Company had $182.9 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 fiscal year 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Mar. 31, 2016 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | B. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited consolidated financial statements at March 31, 2016 and June 30, 2015 and for the three and nine months ended March 31, 2016 and 2015 include the accounts of ImmunoGen, Inc., or the Company, and its wholly owned subsidiaries, ImmunoGen Securities Corp., ImmunoGen Europe Limited and Hurricane, LLC. The consolidated financial statements include all of the adjustments, consisting only of normal recurring adjustments, which management considers necessary for a fair presentation of the Company’s financial position in accordance with accounting principles generally accepted in the U.S. for interim financial information. The June 30, 2015 condensed consolidated balance sheet data presented for comparative purposes was derived from our audited financial statements but certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. The preparation of interim financial statements requires the use of management’s estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements and the reported amounts of revenues and expenditures during the reported periods. The results of the interim periods are not necessarily indicative of the results for the entire year. Accordingly, the interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended June 30, 2015. Subsequent Events The Company has evaluated all events or transactions that occurred after March 31, 2016 up through the date the Company issued these financial statements. The Company did not have any material recognizable or unrecognizable subsequent events during this period. 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 (FASB) Accounting Standards Codification (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 if 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 March 31, 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) (1) Amgen has sublicensed one of its exclusive single-target licenses to Oxford BioTherapeutics Ltd. 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) · 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 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 nine months ended March 31, 2016 and 2015, 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 $7.6 million and $8.7 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 the Company does 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 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 (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. 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 March 31, 2016 and June 30, 2015. 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 March 31, 2016 and June 30, 2015, the Company held $182.9 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 $1.3 million of accrued capital expenditures as of March 31, 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 March 31, 2015 were not material and are included in the consolidated statement of cash flows. Fair Value of Financial Instruments Fair value is defined under ASC Topic 820, “Fair Value Measurements and Disclosures,” 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 March 31, 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 March 31, 2016 (in thousands): Fair Value Measurements at March 31, 2016 Using Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable 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 Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total (Level 1) (Level 2) (Level 3) Cash equivalents $ $ $ — $ — The fair value of the Company’s cash equivalents is based on quoted prices from active markets. Unbilled Revenue The majority of the Company’s unbilled revenue at March 31, 2016 and June 30, 2015 represents research funding earned prior to those dates based on actual resources utilized under the Company’s agreements with various collaborators. 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 March 31, 2016 and June 30, 2015 is summarized below (in thousands): March 31, 2016 June 30, 2015 Raw materials $ $ Work in process Total $ $ Raw materials inventory consists entirely of DM1 and DM4, proprietary cell-killing agents the Company developed as part of its ADC technology. 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. In accordance with this policy, the Company recorded $966,000 of expense related to excess inventory during the nine-months ended March 31, 2016 compared to $42,000 and $434,000 of expense related to excess inventory recorded during the three and nine month periods ended March 31, 2015, respectively. There were no expenses recorded for excess inventory during the three-month period ended March 31, 2016. 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 reserve for work in process inventory is required. 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 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 and restricted stock that are outstanding during the period, except where such non-participating securities would be anti-dilutive. Securities which were considered anti-dilutive and which could potentially dilute basic earnings per share in the future were as follows (in thousands): Three Months Ended March 31, Nine Months Ended March 31, 2016 2015 2016 2015 Options outstanding to purchase common stock and unvested restricted stock 11,679 10,158 11,679 10,158 Common stock equivalents under treasury stock method 361 451 929 738 Stock-Based Compensation As of March 31, 2016, 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 and comprehensive loss 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 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 among its option recipients. 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. Three Months Ended March 31, Nine Months Ended March 31, 2016 2015 2016 2015 Dividend None None None None Volatility 63.90% 60.76% 66.66% 60.46% Risk-free interest rate 1.61% 1.67% 1.85% 1.86% Expected life (years) 6.3 6.3 6.3 6.3 Using the Black-Scholes option-pricing model, the weighted average grant date fair values of options granted during the three months ended March 31, 2016 and 2015 were $5.55 and $3.83 per share, respectively, and $9.70 and $6.06 per share for options granted during the nine months ended March 31, 2016 and 2015, respectively. Stock compensation expense related to stock options and restricted stock awards granted under the 2006 Plan was $7.2 million and $17.4 million during the three and nine months ended March 31, 2016, respectively, compared to stock compensation expense of $3.6 million and $12.5 million for the three and nine months ended March 31, 2015, respectively. During the three and nine months ended March 31, 2016, the Company recorded approximately $2.8 million of compensation expense related to the modification of the terms of certain options previously granted to the CEO of the Company in connection with his planned retirement from the Company. As of March 31, 2016, the estimated fair value of unvested employee awards was $29.4 million, net of estimated forfeitures. The weighted-average remaining vesting period for these awards is approximately two years. During the nine months ended March 31, 2016, holders of options issued under the Company’s equity plans exercised their rights to acquire an aggregate of approximately 498,000 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 $5.0 million. Segment Information During the nine months ended March 31, 2016, the Company continued to operate in one operating segment 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 three and nine months ended March 31, 2016 and 2015 are included in the following table: Three Months Ended March 31, Nine Months Ended March 31, Collaborative Partner: 2016 2015 2016 2015 Bayer 51% —% 19% —% Lilly 7% 1% 13% 24% Novartis —% 44% 1% 44% Roche 37% 45% 37% 19% Takeda 1% —% 18% —% There were no other customers of the Company with significant revenues in the three and nine months ended March 31, 2016 and 2015. Recent Accounting Pronouncements In May 2014, the FASB issued Accounting Standards Update 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. The original effective date would have required the Company to adopt beginning in its first quarter of fiscal 2018. In July 2015, the FASB voted to amend ASU 2014-09 by approving a one-year deferral of the effective date as well as providing the option to early adopt the standard on the original effective date. Accordingly, the Company may adopt the standard in either its first quarter of fiscal 2018 or 2019. 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 Accounting Standards Update 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 def |
Collaborative Agreements
Collaborative Agreements | 9 Months Ended |
Mar. 31, 2016 | |
Collaborative Agreements | |
Collaborative Agreements | C. Collaborative Agreements Roche In May 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. Pursuant to this agreement, Roche developed and received marketing approval for its HER2-targeting ADC compound, Kadcyla, in the U.S., Europe, Japan and numerous other countries. 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, $19.4 million of non-cash royalties on net sales of Kadcyla for the nine-month period ended December 31, 2015 were recorded and included in revenue for the nine months ended March 31, 2016 and $13.9 million of royalties on net sales of Kadcyla for the nine-month period ended December 31, 2014 were included in royalty revenue for the nine months ended March 31, 2015. In April 2015, the Company consummated a royalty purchase transaction — see Note D below for further details. During the nine months ended March 31, 2016, $195,000 of cash royalties were recorded resulting from an adjustment recorded in the period related to net sales of Kadcyla prior to the effective date of the royalty purchase transaction. Amgen Under a now-expired right-to-test agreement, in September 2009, November 2009 and December 2012, Amgen took three exclusive development and commercialization licenses. In May 2013, Amgen took one non-exclusive development and commercialization license. In October 2013, the non-exclusive license was amended and converted to an exclusive license, which Amgen sublicensed 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 licenses 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. 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 nine months ended March 31, 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. Sanofi In July 2003, the Company entered into a broad collaboration agreement with Sanofi (formerly Aventis) to discover, develop and commercialize antibody-based products. The collaboration agreement provided Sanofi with worldwide development and commercialization rights to new antibody-based products directed to targets that were 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. No further targets may be added to this agreement and the product candidates (targets) as of March 31, 2016 in the collaboration include isatuximab (CD38), SAR566658 (CA6), SAR408701 (CEACAM5) and one undisclosed target without an associated clinical-stage product candidate. We are 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 March 31, 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 nine months ended March 31, 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. 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 is further 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 for each license are categorized as follows: development milestones—$10 million; and regulatory milestones—$20 million. The Company was recognizing the $2 million exercise fee 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 the first quarter of fiscal 2015, the Company determined it will 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 Company’s assistance. As a result of this determination, the Company recognized the balance of the upfront exercise fee during the prior period. This change in estimate resulted in an increase to license and milestone fees of $1.6 million for the nine months ended March 31, 2015 compared to amounts that would have been recognized pursuant to the Company’s previous estimate. Pursuant to the license agreement noted above, 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 nine months ended March 31, 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 past involvement in the research and manufacturing of Sanofi’s product candidates, these milestones were deemed substantive. Bayer In October 2008, the Company granted Bayer an exclusive development and commercialization license to the Company’s ADC technology for use with antibodies or other proteins that target mesothelin. 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 royalties 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 March 31, 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 three and nine months ended March 31, 2016. The next potential milestone the Company will be entitled to receive will be either a $2 million development milestone for commencement of a pivotal clinical trial for a second indication for anetumab ravtansine or a $6 million regulatory milestone for filing of regulatory approval for its first indication for anetumab ravtansine. 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 were deemed substantive. Lilly Eli Lilly and Company (Lilly) had the right to take three exclusive development and commercialization licenses under a right-to-test agreement established in December 2011, and took these licenses prior to the expiration of the agreement in December 2014. The Company received a $20 million upfront payment in connection with the execution of the right-to-test agreement in 2011. Under the terms of this right-to-test agreement, the first license had no associated exercise fee, and the second and third licenses each had a $2 million exercise fee. The first development and commercialization license was taken in August 2013 and the agreement was amended in December 2013 to provide Lilly with an extension provision and retrospectively include a $2 million exercise fee for the first license in lieu of the fee due for either the second or third license. The second and third licenses were taken in December 2014, with one including the $2 million exercise fee and the other not. Upon execution of the two licenses in December 2014, the Company recognized the remaining $15.6 million of the $23.5 million of arrangement consideration allocated to the development and commercialization licenses, which is included in license and milestone fee revenue for the nine months ended March 31, 2015. Under the two licenses with the $2 million exercise fee, the Company is entitled to receive up to a total of $199 million in milestone payments, plus royalties on the commercial sales of any resulting products. Under the license taken in December 2014 without the exercise fee, the Company is entitled to receive up to a total of $200.5 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones—$29 million for the two development and commercialization licenses with the $2 million exercise fee, and $30.5 million for the one development and commercialization license with no exercise fee; regulatory milestones—$70 million in all cases; and sales milestones—$100 million in all cases. In September 2015, Lilly initiated Phase I, first-in-human clinical testing of its ADC product candidate, LY3076226, triggering a $5 million milestone payment to the Company which is included in license and milestone fee revenue for the nine months ended March 31, 2016. The next payment the Company could receive would be either a $9 million milestone for commencement of a Phase II clinical trial under this license or a $5 million development milestone payment with the commencement of a Phase I clinical trial under either of its other two licenses. 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 these product candidates, these milestones were deemed substantive. The Company also is entitled to receive payments for delivery of cytotoxic agents to Lilly and research and development activities performed on behalf of Lilly. Lilly is responsible for the manufacturing, product development and marketing of any products resulting from this collaboration. Takeda In March 2015, the Company entered into a right-to-test agreement with Takeda Pharmaceutical Company Limited (Takeda) through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc. The agreement provides Takeda with the right to (a) take exclusive options, with certain restrictions, to individual targets selected by Takeda for specified option periods, (b) test the Company’s ADC technology with Takeda’s antibodies directed to the targets optioned under a right-to-test, or research, license, and (c) take exclusive licenses to use the Company’s ADC technology to develop and commercialize products to targets optioned for up to two individual targets on terms specified in the right-to-test agreement. The Company received a $20 million upfront payment in connection with the execution of the right-to-test agreement. Takeda must exercise its options for the development and commercialization licenses by the end of the three-year term of the right-to-test agreement, after which any then outstanding options will lapse. Takeda has the right to extend the three-year right-to-test period for one additional year by payment to the Company of $4 million. Alternatively, Takeda has the right to expand the scope of the right-to-test agreement by payment to the Company of $8 million. If Takeda opts to expand the scope of the right-to-test agreement, it will be entitled to take additional exclusive options, one of which may be exercised for an additional development and commercialization license, and the right-to test period will be extended until the fifth anniversary of the effective date of the right-to-test agreement. The first exclusive license was taken by Takeda in December 2015, and as a result, the Company recognized $8.6 million of the $25.9 million of arrangement consideration allocated to the development and commercialization licenses, which is included in license and milestone fee revenue for the nine months ended March 31, 2016. Takeda is responsible for the manufacturing, product development and marketing of any products resulting from this collaboration. For each development and commercialization license taken, the Company is entitled to receive up to a total of $210 million in milestone payments, plus royalties on the commercial sales of any resulting products. The total milestones are categorized as follows: development milestones—$30 million; regulatory milestones—$85 million; and sales milestones—$95 million. The first potential milestone the Company will be entitled to receive will be a $5 million development milestone payment with the initiation of a Phase I clinical trial under the first development and commercialization license taken. At the time of execution of this agreement, there was significant uncertainty as to whether the milestone related to initiation of a Phase I clinical trial under the first development and commercialization license would be achieved. In consideration of this, as well as the Company’s expected involvement in the research and manufacturing of these product candidates, this milestone was deemed substantive. The Company also is entitled to receive payments for delivery of cytotoxic agents to Takeda and research and development activities performed on behalf of Takeda. CytomX In January 2014, the Company entered into a reciprocal right-to-test agreement with CytomX Therapeutics, Inc. (CytomX). The agreement provides CytomX and the Company with the right to test the Company’s ADC technology with CytomX masked antibodies, which it calls Probodies™, to create product candidates for a specified number of targets. Each company has defined rights to test the other company’s technology with its technology under a right-to-test, or research, license, and to subsequently take an exclusive, worldwide license to use the other company’s technology with its technology to develop and commercialize products for the specified targets on terms agreed upon at the inception of the right-to-test agreement. The Company received no upfront cash payment in connection with the execution of the right-to-test agreement. The terms of the right-to-test agreement require the Company and CytomX to each take its respective development and commercialization licenses by the end of the term of the research licenses. In addition, both the Company and CytomX are required to perform specific research activities under the right-to-test agreement on behalf of the other party for no monetary consideration. In February 2016, CytomX took its development and commercialization license for a specified target. An amendment of the agreement executed simultaneously with that license granted CytomX the right, for a specified period of time, to substitute the specified target with another as yet unspecified target. Accordingly, the revenue associated with this license is being deferred until the expiration of that substitution right. With respect to the development and commercialization license taken by CytomX, the Company is entitled to receive up to a total of $160 million in milestone payments plus royalties on the commercial sales of any resulting product. The total milestones are categorized as follows: development milestones—$10 million; regulatory milestones—$50 million; and sales milestones—$100 million. In addition, CytomX may be liable to pay annual maintenance fees if the licensed product candidate covered under the development and commercialization license has not progressed to a specified stage of development within a specified time frame. Assuming no annual maintenance fee is payable, the next payment the Company could receive would be a $1 million development milestone payment with commencement of a Phase I clinical trial. At the time of execution of the right-to-test agreement, there was significant uncertainty as to whether the milestone related to the Phase I clinical trial would be achieved. In consideration of this, as well as the Company’s expected involvement in the research and manufacturing of any product candidate, this milestone was deemed substantive. CytomX is responsible for the manufacturing, product development and marketing of any product resulting from the development and commercialization license taken by CytomX under this collaboration. |
Liability Related to Sale of Fu
Liability Related to Sale of Future Royalties | 9 Months Ended |
Mar. 31, 2016 | |
Liability Related to Sale of Future Royalties | |
Liability Related to Sale of Future Royalties | D. Liability Related to Sale of Future Royalties In April 2015, Immunity Royalty Holdings, L.P. (IRH) purchased the right to receive 100% of the royalty payments on commercial sales of Kadcyla subsequent to December 31, 2014, arising under the Company’s development and commercialization license with Genentech (a unit of Roche), 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 presented 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 nine-month period ended March 31, 2016 (in thousands): Period from June 30, 2015 to March 31, 2016 Liability related to sale of future royalties — beginning balance $ 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. Through March 31, 2016, $24.8 million in cumulative royalty payments have been received from Roche and paid to IRH. 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 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. |
Capital Stock
Capital Stock | 9 Months Ended |
Mar. 31, 2016 | |
Capital Stock | |
Capital Stock | E. Capital Stock 2001 Non-Employee Director Stock Plan During the three and nine months ended March 31, 2016, the Company recorded approximately ($32,000) and $(37,000) in expense reduction related to stock units outstanding under the Company’s 2001 Non-Employee Director Stock Plan, or the 2001 Plan, compared to $18,000 and $(19,000) in expense and expense reduction recorded during the three and nine months ended March 31, 2015. The value of the stock units are classified as a liability and adjusted to market value at each reporting period as the redemption amount of stock units for this plan will be paid in cash. No stock units have been issued under the 2001 Plan subsequent to June 30, 2004. Compensation Policy for Non-Employee Directors 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 also entitled to receive a fixed number of stock 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 stock options in November of 2015 and 2014, respectively, and the related compensation expense for the three and nine months ended March 31, 2016 and 2015 is included in the amounts discussed in the “Stock-Based Compensation” section of footnote B above. During the three and nine months ended March 31, 2016 , the Company recorded approximately $108,000 and $272,000 in compensation expense, respectively, related to deferred share units issued and outstanding under the Company’s Compensation Policy for Non-Employee Directors, compared to $93,000 and $329,000 in compensation expense recorded during the three and nine months ended March 31, 2015. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Mar. 31, 2016 | |
Commitments and Contingencies | |
Commitments and Contingencies | F. 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. The term of the lease is for five years and two months commencing upon delivery of the premises to the Company for its use which is anticipated to be approximately May 1, 2016. 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 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 is 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 from January 2015 through July 2018. The minimum rental commitments for the Company’s facilities, 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): 2016 (three months remaining) $ 2017 2018 2019 2020 Thereafter Total minimum lease payments $ Total minimum rental payments from sublease ) Total minimum lease payments, net $ There are no obligations under capital leases as of March 31, 2016, as all of the capital leases were single payment obligations which have all been made. Collaborations The Company is contractually obligated to make potential future success-based development, regulatory or sales 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 March 31, 2016, 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. |
Summary of Significant Accoun12
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Mar. 31, 2016 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying unaudited consolidated financial statements at March 31, 2016 and June 30, 2015 and for the three and nine months ended March 31, 2016 and 2015 include the accounts of ImmunoGen, Inc., or the Company, and its wholly owned subsidiaries, ImmunoGen Securities Corp., ImmunoGen Europe Limited and Hurricane, LLC. The consolidated financial statements include all of the adjustments, consisting only of normal recurring adjustments, which management considers necessary for a fair presentation of the Company’s financial position in accordance with accounting principles generally accepted in the U.S. for interim financial information. The June 30, 2015 condensed consolidated balance sheet data presented for comparative purposes was derived from our audited financial statements but certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. The preparation of interim financial statements requires the use of management’s estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the interim financial statements and the reported amounts of revenues and expenditures during the reported periods. The results of the interim periods are not necessarily indicative of the results for the entire year. Accordingly, the interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended June 30, 2015. |
Subsequent Events | Subsequent Events The Company has evaluated all events or transactions that occurred after March 31, 2016 up through the date the Company issued these financial statements. The Company did not have any material recognizable or unrecognizable subsequent events during this period. |
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 (FASB) Accounting Standards Codification (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 if 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 March 31, 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) (1) Amgen has sublicensed one of its exclusive single-target licenses to Oxford BioTherapeutics Ltd. 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) · 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 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 nine months ended March 31, 2016 and 2015, 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 $7.6 million and $8.7 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 the Company does 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 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 (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. |
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 March 31, 2016 and June 30, 2015. 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 March 31, 2016 and June 30, 2015, the Company held $182.9 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 $1.3 million of accrued capital expenditures as of March 31, 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 March 31, 2015 were not material and are included in the consolidated statement of cash flows. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined under ASC Topic 820, “Fair Value Measurements and Disclosures,” 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 March 31, 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 March 31, 2016 (in thousands): Fair Value Measurements at March 31, 2016 Using Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable 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 Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total (Level 1) (Level 2) (Level 3) Cash equivalents $ $ $ — $ — The fair value of the Company’s cash equivalents is based on quoted prices from active markets. |
Unbilled Revenue | Unbilled Revenue The majority of the Company’s unbilled revenue at March 31, 2016 and June 30, 2015 represents research funding earned prior to those dates based on actual resources utilized under the Company’s agreements with various collaborators. |
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 March 31, 2016 and June 30, 2015 is summarized below (in thousands): March 31, 2016 June 30, 2015 Raw materials $ $ Work in process Total $ $ Raw materials inventory consists entirely of DM1 and DM4, proprietary cell-killing agents the Company developed as part of its ADC technology. 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. In accordance with this policy, the Company recorded $966,000 of expense related to excess inventory during the nine-months ended March 31, 2016 compared to $42,000 and $434,000 of expense related to excess inventory recorded during the three and nine month periods ended March 31, 2015, respectively. There were no expenses recorded for excess inventory during the three-month period ended March 31, 2016. 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 reserve for work in process inventory is required. |
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 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 and restricted stock that are outstanding during the period, except where such non-participating securities would be anti-dilutive. Securities which were considered anti-dilutive and which could potentially dilute basic earnings per share in the future were as follows (in thousands): Three Months Ended March 31, Nine Months Ended March 31, 2016 2015 2016 2015 Options outstanding to purchase common stock and unvested restricted stock 11,679 10,158 11,679 10,158 Common stock equivalents under treasury stock method 361 451 929 738 |
Stock-Based Compensation | Stock-Based Compensation As of March 31, 2016, 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 and comprehensive loss 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 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 among its option recipients. 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. Three Months Ended March 31, Nine Months Ended March 31, 2016 2015 2016 2015 Dividend None None None None Volatility 63.90% 60.76% 66.66% 60.46% Risk-free interest rate 1.61% 1.67% 1.85% 1.86% Expected life (years) 6.3 6.3 6.3 6.3 Using the Black-Scholes option-pricing model, the weighted average grant date fair values of options granted during the three months ended March 31, 2016 and 2015 were $5.55 and $3.83 per share, respectively, and $9.70 and $6.06 per share for options granted during the nine months ended March 31, 2016 and 2015, respectively. Stock compensation expense related to stock options and restricted stock awards granted under the 2006 Plan was $7.2 million and $17.4 million during the three and nine months ended March 31, 2016, respectively, compared to stock compensation expense of $3.6 million and $12.5 million for the three and nine months ended March 31, 2015, respectively. During the three and nine months ended March 31, 2016, the Company recorded approximately $2.8 million of compensation expense related to the modification of the terms of certain options previously granted to the CEO of the Company in connection with his planned retirement from the Company. As of March 31, 2016, the estimated fair value of unvested employee awards was $29.4 million, net of estimated forfeitures. The weighted-average remaining vesting period for these awards is approximately two years. During the nine months ended March 31, 2016 , holders of options issued under the Company’s equity plans exercised their rights to acquire an aggregate of approximately 498,000 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 $5.0 million. |
Segment Information | Segment Information During the nine months ended March 31, 2016 , the Company continued to operate in one operating segment 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 three and nine months ended March 31, 2016 and 2015 are included in the following table: Three Months Ended March 31, Nine Months Ended March 31, Collaborative Partner: 2016 2015 2016 2015 Bayer 51% —% 19% —% Lilly 7% 1% 13% 24% Novartis —% 44% 1% 44% Roche 37% 45% 37% 19% Takeda 1% —% 18% —% There were no other customers of the Company with significant revenues in the three and nine months ended March 31, 2016 and 2015. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the FASB issued Accounting Standards Update 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. The original effective date would have required the Company to adopt beginning in its first quarter of fiscal 2018. In July 2015, the FASB voted to amend ASU 2014-09 by approving a one-year deferral of the effective date as well as providing the option to early adopt the standard on the original effective date. Accordingly, the Company may adopt the standard in either its first quarter of fiscal 2018 or 2019. 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 Accounting Standards Update 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 ending after December 15, 2016, and interim periods thereafter, with early application permitted. Accordingly, the standard is effective for the Company on June 30, 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 Accounting Standards Update 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 March 31, 2016 includes in assets $4.7 million of debt issuance costs classified as deferred financing costs. In July 2015, the FASB issued Accounting Standards Update 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 July 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 Accounting Standards Update 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, resulting in a reduction of long-term assets and current liabilities of approximately $843,000 as of March 31, 2016. The prior period balances were not retrospectively adjusted. In January 2016, the FASB issued Accounting Standards Update 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 July 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 Accounting Standards Update 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, with early adoption permitted. Accordingly, the standard is effective for the Company on July 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 Accounting Standards Update 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 July 1, 2017. The Company is currently evaluating the impact of this guidance on our financial statements and the timing of adoption. |
Summary of Significant Accoun13
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Mar. 31, 2016 | |
Summary of Significant Accounting Policies | |
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 March 31, 2016 (in thousands): Fair Value Measurements at March 31, 2016 Using Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total (Level 1) (Level 2) (Level 3) Cash equivalents $ $ $ — $ — 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 Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Total (Level 1) (Level 2) (Level 3) Cash equivalents $ $ $ — $ — |
Schedule of inventory | Inventory at March 31, 2016 and June 30, 2015 is summarized below (in thousands): March 31, 2016 June 30, 2015 Raw materials $ $ Work in process Total $ $ |
Schedule of common stock equivalents, as calculated in accordance with the treasury-stock method | Securities which were considered anti-dilutive and which could potentially dilute basic earnings per share in the future were as follows (in thousands): Three Months Ended March 31, Nine Months Ended March 31, 2016 2015 2016 2015 Options outstanding to purchase common stock and unvested restricted stock 11,679 10,158 11,679 10,158 Common stock equivalents under treasury stock method 361 451 929 738 |
Schedule of risk-free rate of the stock options based on U.S.Treasury rate | Three Months Ended March 31, Nine Months Ended March 31, 2016 2015 2016 2015 Dividend None None None None Volatility 63.90% 60.76% 66.66% 60.46% Risk-free interest rate 1.61% 1.67% 1.85% 1.86% Expected life (years) 6.3 6.3 6.3 6.3 |
Schedule of percentage of total revenues recognized from each significant customer | Three Months Ended March 31, Nine Months Ended March 31, Collaborative Partner: 2016 2015 2016 2015 Bayer 51% —% 19% —% Lilly 7% 1% 13% 24% Novartis —% 44% 1% 44% Roche 37% 45% 37% 19% Takeda 1% —% 18% —% |
Liability Related to Sale of 14
Liability Related to Sale of Future Royalties (Tables) | 9 Months Ended |
Mar. 31, 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 nine-month period ended March 31, 2016 (in thousands): Period from June 30, 2015 to March 31, 2016 Liability related to sale of future royalties — beginning balance $ Non-cash Kadcyla royalty revenue ) Non-cash interest expense recognized Liability related to sale of future royalties — ending balance $ |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Mar. 31, 2016 | |
Commitments and Contingencies | |
Minimum rental commitments for the next five fiscal years and thereafter under the non-cancelable operating lease agreements | The minimum rental commitments for the Company’s facilities, 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): imgl 2016 (three months remaining) $ 2017 2018 2019 2020 Thereafter Total minimum lease payments $ Total minimum rental payments from sublease ) Total minimum lease payments, net $ |
Nature of Business and Plan o16
Nature of Business and Plan of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Mar. 31, 2016 | Mar. 31, 2015 | Mar. 31, 2016 | Mar. 31, 2015 | Jun. 30, 2015 | Jun. 30, 2014 | |
Nature of Business and Plan of Operations | ||||||
Net loss | $ (31,928) | $ (21,618) | $ (98,895) | $ (30,265) | ||
Accumulated deficit | (807,765) | (807,765) | $ (708,870) | |||
Cash and cash equivalents | $ 182,913 | $ 111,827 | $ 182,913 | $ 111,827 | $ 278,109 | $ 142,261 |
Summary of Significant Accoun17
Summary of Significant Accounting Policies - Revenue recognition, Financial Instruments and Concentration of Credit Risk (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 10 Months Ended | 40 Months Ended | 153 Months Ended | |||||||||
Sep. 30, 2015USD ($) | Jan. 31, 2014USD ($) | May. 31, 2013item | Dec. 31, 2012item | Dec. 31, 2011USD ($)item | Nov. 30, 2009item | Sep. 30, 2009item | Mar. 31, 2015USD ($)item | Mar. 31, 2016USD ($)item | Mar. 31, 2015USD ($) | Dec. 31, 2015USD ($) | Mar. 31, 2015USD ($) | Mar. 31, 2016USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | |
Summary of Significant Accounting Policies | |||||||||||||||
Number of types of licensing and development agreements with collaborative partners | 2 | ||||||||||||||
Cash and cash equivalents | $ | $ 111,827,000 | $ 182,913,000 | $ 111,827,000 | $ 111,827,000 | $ 182,913,000 | $ 278,109,000 | $ 142,261,000 | ||||||||
Financial Instruments and Concentration of Credit Risk | |||||||||||||||
Number of financial institutions in the U.S. in which cash and cash equivalents are primarily maintained | 3 | ||||||||||||||
Number of marketable securities held by entity | $ | $ 0 | 0 | $ 0 | ||||||||||||
Noncash Investing Activities | |||||||||||||||
Accrued capital expenditures | $ | 1,300,000 | ||||||||||||||
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 | $ | $ 7,600,000 | $ 8,700,000 | |||||||||||||
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 license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 4 | ||||||||||||||
Amgen | Development and Commercialization License | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 2 | ||||||||||||||
Amgen | Development and Commercialization License | Exclusive license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 2 | ||||||||||||||
Amgen | Development and Commercialization License | Non-exclusive license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 1 | ||||||||||||||
Amgen | Right-to-test agreement | Exclusive license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 3 | 3 | 3 | ||||||||||||
Bayer HealthCare | Development and Commercialization License | Exclusive license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 1 | ||||||||||||||
Biotest | Development and Commercialization License | Exclusive license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 1 | ||||||||||||||
CytomX | Development and Commercialization License | Exclusive license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 1 | ||||||||||||||
CytomX | Right-to-test agreement | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Proceeds from Collaborators | $ | $ 0 | ||||||||||||||
Lilly | Development and Commercialization License | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Proceeds from Collaborators | $ | $ 23,500,000 | ||||||||||||||
Lilly | Development and Commercialization License | Phase I clinical trial | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 2 | ||||||||||||||
Lilly | Development and Commercialization License | Phase I clinical trial | Development milestones | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Proceeds from Collaborators | $ | $ 5,000,000 | ||||||||||||||
Lilly | Development and Commercialization License | Exclusive license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 3 | ||||||||||||||
Lilly | Right-to-test agreement | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Proceeds from Collaborators | $ | $ 20,000,000 | ||||||||||||||
Number of single-target licenses | 3 | ||||||||||||||
Novartis | Development and Commercialization License | Exclusive license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 5 | ||||||||||||||
Number of licenses to two related targets | 1 | ||||||||||||||
Number of related targets | 2 | ||||||||||||||
Roche | Development and Commercialization License | Exclusive license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 5 | ||||||||||||||
Sanofi | Development and Commercialization License | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Proceeds from Collaborators | $ | $ 20,500,000 | ||||||||||||||
Number of related targets | 1 | ||||||||||||||
Sanofi | Development and Commercialization License | Exclusive license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 1 | ||||||||||||||
Number of licenses to multiple individual targets | 1 | ||||||||||||||
Takeda | Development and Commercialization License | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Proceeds from Collaborators | $ | $ 25,900,000 | ||||||||||||||
Takeda | Development and Commercialization License | Exclusive license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 1 | ||||||||||||||
Takeda | Right-to-test agreement | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Proceeds from Collaborators | $ | $ 20,000,000 | ||||||||||||||
Takeda | Right-to-test agreement | Maximum | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 2 | ||||||||||||||
Oxford BioTherapeutics Ltd Member | Amgen | Development and Commercialization License | Exclusive license | |||||||||||||||
Summary of Significant Accounting Policies | |||||||||||||||
Number of single-target licenses | 1 |
Summary of Significant Accoun18
Summary of Significant Accounting Policies - Fair Value of Financial Instruments (Details) - Recurring basis - USD ($) $ in Thousands | Mar. 31, 2016 | Jun. 30, 2015 |
Fair value hierarchy for the Company's financial assets measured at fair value | ||
Cash equivalents | $ 157,585 | $ 269,304 |
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 | $ 157,585 | $ 269,304 |
Summary of Significant Accoun19
Summary of Significant Accounting Policies - Inventory and Computation of Net Loss per Common Share (Details) - USD ($) shares in Thousands | 3 Months Ended | 9 Months Ended | |||
Mar. 31, 2016 | Mar. 31, 2015 | Mar. 31, 2016 | Mar. 31, 2015 | Jun. 30, 2015 | |
Inventory | |||||
Raw materials | $ 318,000 | $ 318,000 | $ 279,000 | ||
Work in process | 590,000 | 590,000 | 2,656,000 | ||
Total | 908,000 | $ 908,000 | $ 2,935,000 | ||
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 | ||||
Charges to research and development expense related to raw material inventory identified as excess | $ 42,000 | $ 966,000 | $ 434,000 | ||
Value of excess inventory | 0 | 0 | |||
Reserve for work in process | $ 0 | $ 0 | |||
Computation of Net Income (Loss) per Common Share | |||||
Options outstanding to purchase common stock and unvested restricted stock (in shares) | 11,679 | 10,158 | 11,679 | 10,158 | |
Common stock equivalents under treasury stock method (in shares) | 361 | 451 | 929 | 738 |
Summary of Significant Accoun20
Summary of Significant Accounting Policies - Stock-Based Compensation (Details) $ / shares in Units, $ in Thousands | Nov. 11, 2014shares | Mar. 31, 2016USD ($)$ / shares | Mar. 31, 2015USD ($)$ / shares | Mar. 31, 2016USD ($)item$ / sharesshares | Mar. 31, 2015USD ($)$ / shares |
Additional disclosure for options | |||||
Cash received for exercise of stock options | $ 4,979 | $ 1,432 | |||
2006 Plan | |||||
Stock-Based Compensation | |||||
Number of employee share-based compensation plans | item | 1 | ||||
Additional number of shares authorized for issuance | shares | 5,500,000 | ||||
Common stock authorized for issuance (in shares) | shares | 17,500,000 | ||||
Additional disclosure for options | |||||
Stock compensation expense | $ 4,400 | $ 3,600 | $ 14,600 | $ 12,500 | |
Estimated fair value of unvested employee awards, net of estimated forfeitures | $ 29,400 | ||||
Weighted average vesting period of unvested employee awards | 2 years | ||||
Number of Stock Options | |||||
Granted (in shares) | shares | 1,676,599 | ||||
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% | 0.00% | |
Volatility (as a percent) | 63.90% | 60.76% | 66.66% | 60.46% | |
Risk-free interest rate (as a percent) | 1.61% | 1.67% | 1.85% | 1.86% | |
Expected life | 6 years 3 months 18 days | 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 | $ 5.55 | $ 3.83 | $ 9.70 | $ 6.06 | |
Additional disclosure for options | |||||
Stock compensation expense | $ 2,800 | $ 2,800 | |||
Stock options exercised (in shares) | shares | 498,000 | ||||
Cash received for exercise of stock options | $ 5,000 | ||||
2006 Plan | Stock options | Maximum | |||||
Stock-Based Compensation | |||||
Vesting period | 4 years | ||||
Exercise period | 10 years | ||||
Additional disclosure for options | |||||
Exercised (in dollars per share) | $ / shares | $ 17 | ||||
2006 Plan | Stock options | Minimum | |||||
Additional disclosure for options | |||||
Exercised (in dollars per share) | $ / shares | $ 3.19 |
Summary of Significant Accoun21
Summary of Significant Accounting Policies - Segment Information (Details) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2016USD ($) | Mar. 31, 2015 | Mar. 31, 2016USD ($)item | Mar. 31, 2015 | |
Segment Information | ||||
Number of operating segments | item | 1 | |||
Recent Accounting Pronouncements | ||||
Deferred financing costs | $ 4,700,000 | $ 4,700,000 | ||
Reduction in long-term assets and Liabilities, current | $ 843,000 | $ 843,000 | ||
Bayer HealthCare | Revenues Percentage | ||||
Collaborative Partner: | ||||
Percentages of revenue recognized | 51.00% | 19.00% | ||
Takeda | Revenues Percentage | ||||
Collaborative Partner: | ||||
Percentages of revenue recognized | 1.00% | 18.00% | ||
Novartis | Revenues Percentage | ||||
Collaborative Partner: | ||||
Percentages of revenue recognized | 44.00% | 1.00% | 44.00% | |
Lilly | Revenues Percentage | ||||
Collaborative Partner: | ||||
Percentages of revenue recognized | 7.00% | 1.00% | 13.00% | 24.00% |
Roche | Revenues Percentage | ||||
Collaborative Partner: | ||||
Percentages of revenue recognized | 37.00% | 45.00% | 37.00% | 19.00% |
Collaborative Agreements - Roch
Collaborative Agreements - Roche (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2016 | Mar. 31, 2015 | Mar. 31, 2016 | Mar. 31, 2015 | |
Collaborative Agreements disclosures | ||||
Non-cash royalty revenue related to sale of future royalties | $ 7,380,000 | $ 19,355,000 | ||
Royalties on net sales of Kadcyla | $ 5,099,000 | $ 195,000 | $ 13,890,000 | |
Exclusive license | Roche | Development and Commercialization License | Kadcyla | ||||
Collaborative Agreements disclosures | ||||
Period in arrears to receive royalty reports and payments related to sales of Kadcyla | 1 month | |||
Non-cash royalty revenue related to sale of future royalties | $ 19,400,000 | |||
Royalties on net sales of Kadcyla | $ 195,000 | $ 13,900,000 |
Collaborative Agreements - Amge
Collaborative Agreements - Amgen (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
May. 31, 2013USD ($)item | Dec. 31, 2012item | Nov. 30, 2009item | Sep. 30, 2009item | Mar. 31, 2016USD ($) | Mar. 31, 2015USD ($) | Mar. 31, 2016USD ($)item | Mar. 31, 2015USD ($) | Oct. 31, 2013USD ($) | |
Collaborative Agreements disclosures | |||||||||
Amount of arrangement consideration included in license and milestone fees | $ 10,077 | $ 5,078 | $ 26,839 | $ 52,729 | |||||
Amgen | Development milestones | Phase II clinical trial | |||||||||
Collaborative Agreements disclosures | |||||||||
Potential milestone payments | $ 3,000 | $ 3,000 | |||||||
Amgen | Exclusive license | |||||||||
Collaborative Agreements disclosures | |||||||||
Number of single-target licenses | item | 4 | ||||||||
Amgen | Exclusive license | AMG595 and AMG172 | |||||||||
Collaborative Agreements disclosures | |||||||||
Number of single-target licenses | item | 2 | ||||||||
Amgen | Development and Commercialization License | |||||||||
Collaborative Agreements disclosures | |||||||||
Number of single-target licenses | item | 2 | ||||||||
Potential milestone payments | $ 34,000 | ||||||||
Amgen | Development and Commercialization License | IND application effective | |||||||||
Collaborative Agreements disclosures | |||||||||
Potential milestone payments | $ 1,000 | ||||||||
Amount of arrangement consideration included in license and milestone fees | $ 1,000 | ||||||||
Amgen | Development and Commercialization License | Development milestones | |||||||||
Collaborative Agreements disclosures | |||||||||
Potential milestone payments | 9,000 | ||||||||
Amgen | Development and Commercialization License | Regulatory milestones | |||||||||
Collaborative Agreements disclosures | |||||||||
Potential milestone payments | 20,000 | ||||||||
Amgen | Development and Commercialization License | Sales milestones | |||||||||
Collaborative Agreements disclosures | |||||||||
Potential milestone payments | $ 5,000 | ||||||||
Amgen | Development and Commercialization License | Exclusive license | |||||||||
Collaborative Agreements disclosures | |||||||||
Number of single-target licenses | item | 2 | ||||||||
Amgen | Development and Commercialization License | Non-exclusive license | |||||||||
Collaborative Agreements disclosures | |||||||||
Number of single-target licenses | item | 1 | ||||||||
Amgen | Right-to-test agreement | Exclusive license | |||||||||
Collaborative Agreements disclosures | |||||||||
Number of single-target licenses | item | 3 | 3 | 3 |
Collaborative Agreements - Sano
Collaborative Agreements - Sanofi (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 153 Months Ended | ||||
Dec. 31, 2013USD ($) | Mar. 31, 2016USD ($) | Mar. 31, 2015USD ($) | Mar. 31, 2016USD ($)item | Mar. 31, 2015USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2006USD ($) | Jul. 31, 2003USD ($) | |
Collaborative Agreements disclosures | ||||||||
License and milestone fees | $ 10,077 | $ 5,078 | $ 26,839 | $ 52,729 | ||||
Sanofi | Development and Commercialization License | ||||||||
Collaborative Agreements disclosures | ||||||||
Number of undisclosed targets with exclusive licenses | item | 1 | |||||||
Potential milestone payments | $ 21,500 | |||||||
Payments received under collaboration agreement | $ 20,500 | |||||||
Fee received per license | $ 2,000 | |||||||
License and milestone fees | 1,600 | |||||||
Sanofi | Development and Commercialization License | Maximum | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments | $ 30,000 | |||||||
Sanofi | Development and Commercialization License | Phase IIb clinical trial | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments | 4,000 | $ 4,000 | 4,000 | |||||
Sanofi | Development and Commercialization License | Development milestones | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments | 10,000 | 7,500 | ||||||
Sanofi | Development and Commercialization License | Regulatory milestones | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments | $ 20,000 | 14,000 | ||||||
Sanofi | Development and Commercialization License | Undisclosed Target | Development milestones | Phase I clinical trial | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments | 1,000 | |||||||
Sanofi | Development and Commercialization License | SAR566658 | Development milestones | Phase IIb clinical trial | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments | 3,000 | |||||||
Sanofi | Development and Commercialization License | Isatuximab | Phase IIb clinical trial | ||||||||
Collaborative Agreements disclosures | ||||||||
Payments received under collaboration agreement | 3,000 | |||||||
Sanofi | Development and Commercialization License | Isatuximab | Development milestones | Phase III clinical trial | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments | $ 3,000 | |||||||
Sanofi | Development and Commercialization License | SAR408701 | Phase I clinical trial | ||||||||
Collaborative Agreements disclosures | ||||||||
Payments received under collaboration agreement | $ 1,000 | |||||||
Sanofi | Development and Commercialization License | SAR408701 | Development milestones | Phase IIb clinical trial | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments | $ 3,000 | 3,000 | $ 3,000 | |||||
Sanofi | Development and Commercialization License | SAR428926 | Phase I clinical trial | ||||||||
Collaborative Agreements disclosures | ||||||||
License and milestone fees | $ 2,000 |
Collaborative Agreements - Baye
Collaborative Agreements - Bayer (Details) - Bayer HealthCare - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended | |
Jan. 31, 2016 | Oct. 31, 2008 | Mar. 31, 2016 | |
Development milestones | Phase II clinical trial | Anetumab Ravtansine | |||
Collaborative Agreements disclosures | |||
Payments received under collaboration agreement | $ 10 | ||
Exclusive license | |||
Collaborative Agreements disclosures | |||
Payments received under collaboration agreement | $ 4 | $ 13 | |
Potential milestone payments | 170.5 | ||
Exclusive license | Development milestones | |||
Collaborative Agreements disclosures | |||
Potential milestone payments | 16 | 2 | |
Exclusive license | Regulatory milestones | |||
Collaborative Agreements disclosures | |||
Potential milestone payments | 44.5 | $ 6 | |
Exclusive license | Sales milestones | |||
Collaborative Agreements disclosures | |||
Potential milestone payments | $ 110 |
Collaborative Agreements - Lill
Collaborative Agreements - Lilly (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 40 Months Ended | ||||
Sep. 30, 2015USD ($) | Dec. 31, 2011USD ($)item | Mar. 31, 2016USD ($) | Mar. 31, 2015USD ($) | Mar. 31, 2016USD ($)item | Mar. 31, 2015USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2013USD ($) | |
Collaborative Agreements disclosures | ||||||||
Amount of arrangement consideration included in license and milestone fees | $ 10,077 | $ 5,078 | $ 26,839 | $ 52,729 | ||||
Lilly | Right-to-test agreement | ||||||||
Collaborative Agreements disclosures | ||||||||
Number of development and commercialization licenses taken | item | 3 | |||||||
Payments received under collaboration agreement | $ 20,000 | |||||||
Lilly | Right-to-test agreement | No exercise fee | ||||||||
Collaborative Agreements disclosures | ||||||||
License exercise fee, per subsequent license | 0 | |||||||
Lilly | Right-to-test agreement | Exercise fee of $2 million | ||||||||
Collaborative Agreements disclosures | ||||||||
License exercise fee, per subsequent license | $ 2,000 | $ 2,000 | ||||||
Lilly | Development and Commercialization License | ||||||||
Collaborative Agreements disclosures | ||||||||
Payments received under collaboration agreement | $ 23,500 | |||||||
Amount of arrangement consideration included in license and milestone fees | 15,600 | 15,600 | ||||||
Lilly | Development and Commercialization License | Exclusive license | ||||||||
Collaborative Agreements disclosures | ||||||||
Number of development and commercialization licenses taken | item | 3 | |||||||
Lilly | Development and Commercialization License | No exercise fee | ||||||||
Collaborative Agreements disclosures | ||||||||
Number of development and commercialization licenses taken | item | 1 | |||||||
Lilly | Development and Commercialization License | No exercise fee | Maximum | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments for each subsequent license | 200,500 | 200,500 | 200,500 | |||||
Lilly | Development and Commercialization License | Exercise fee of $2 million | ||||||||
Collaborative Agreements disclosures | ||||||||
Number of development and commercialization licenses taken | item | 2 | 2 | ||||||
License exercise fee, per subsequent license | 2,000 | 2,000 | 2,000 | |||||
Lilly | Development and Commercialization License | Exercise fee of $2 million | Maximum | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments for each subsequent license | 199,000 | 199,000 | 199,000 | |||||
Lilly | Development and Commercialization License | Phase I clinical trial | ||||||||
Collaborative Agreements disclosures | ||||||||
Number of development and commercialization licenses taken | item | 2 | |||||||
Lilly | Development and Commercialization License | Development milestones | No exercise fee | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments for each subsequent license | 30,500 | 30,500 | 30,500 | |||||
Lilly | Development and Commercialization License | Development milestones | Exercise fee of $2 million | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments for each subsequent license | 29,000 | 29,000 | 29,000 | |||||
Lilly | Development and Commercialization License | Development milestones | Phase I clinical trial | ||||||||
Collaborative Agreements disclosures | ||||||||
Payments received under collaboration agreement | $ 5,000 | |||||||
Potential milestone payments for each subsequent license | $ 5,000 | $ 5,000 | ||||||
Lilly | Development and Commercialization License | Development milestones | Phase II clinical trial | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments for each subsequent license | $ 9,000 | |||||||
Lilly | Development and Commercialization License | Regulatory milestones | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments for each subsequent license | 70,000 | 70,000 | 70,000 | |||||
Lilly | Development and Commercialization License | Sales milestones | ||||||||
Collaborative Agreements disclosures | ||||||||
Potential milestone payments for each subsequent license | $ 100,000 | $ 100,000 | $ 100,000 |
Collaborative Agreements - Take
Collaborative Agreements - Takeda (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | 10 Months Ended | ||
Mar. 31, 2016USD ($) | Mar. 31, 2015USD ($)item | Mar. 31, 2016USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2015USD ($) | |
Collaborative Agreements disclosures | |||||
Amount of arrangement consideration included in license and milestone fees | $ 10,077 | $ 5,078 | $ 26,839 | $ 52,729 | |
Takeda | Right-to-test agreement | |||||
Collaborative Agreements disclosures | |||||
Term of agreement | 3 years | ||||
Term of extension of the agreement | 1 year | ||||
Payments to be made for extension of agreement | $ 4,000 | ||||
Payments received under collaboration agreement | $ 20,000 | ||||
Takeda | Right-to-test agreement | Maximum | |||||
Collaborative Agreements disclosures | |||||
Number of single-target licenses | item | 2 | ||||
Takeda | Right-to-test agreement | Option To Expand Agreement | |||||
Collaborative Agreements disclosures | |||||
Payments to be made for extension of agreement | $ 8,000 | ||||
Takeda | Development and Commercialization License | |||||
Collaborative Agreements disclosures | |||||
Payments received under collaboration agreement | $ 25,900 | ||||
Amount of arrangement consideration included in license and milestone fees | 8,600 | ||||
Takeda | Development and Commercialization License | Maximum | |||||
Collaborative Agreements disclosures | |||||
Potential milestone payments | 210,000 | 210,000 | |||
Takeda | Development and Commercialization License | Development milestones | |||||
Collaborative Agreements disclosures | |||||
Potential milestone payments | 30,000 | 30,000 | |||
Takeda | Development and Commercialization License | Development milestones | Phase I clinical trial | |||||
Collaborative Agreements disclosures | |||||
Potential milestone payments | 5,000 | 5,000 | |||
Takeda | Development and Commercialization License | Regulatory milestones | |||||
Collaborative Agreements disclosures | |||||
Potential milestone payments | 85,000 | 85,000 | |||
Takeda | Development and Commercialization License | Sales milestones | |||||
Collaborative Agreements disclosures | |||||
Potential milestone payments | $ 95,000 | $ 95,000 |
Collaborative Agreements - Cyto
Collaborative Agreements - CytomX (Details) - CytomX - USD ($) $ in Millions | 1 Months Ended | |
Jan. 31, 2014 | Feb. 29, 2016 | |
Right-to-test agreement | ||
Collaborative Agreements disclosures | ||
Payments received under collaboration agreement | $ 0 | |
Development and Commercialization License | Maximum | ||
Collaborative Agreements disclosures | ||
Potential milestone payments | $ 160 | |
Development and Commercialization License | Development milestones | ||
Collaborative Agreements disclosures | ||
Potential milestone payments | 10 | |
Development and Commercialization License | Development milestones | Phase I clinical trial | ||
Collaborative Agreements disclosures | ||
Potential milestone payments | 1 | |
Development and Commercialization License | Regulatory milestones | ||
Collaborative Agreements disclosures | ||
Potential milestone payments | 50 | |
Development and Commercialization License | Sales milestones | ||
Collaborative Agreements disclosures | ||
Potential milestone payments | $ 100 |
Liability Related to Sale of 29
Liability Related to Sale of Future Royalties (Details) - USD ($) $ in Thousands | Mar. 31, 2016 | Apr. 30, 2015 | Mar. 31, 2015 | Mar. 31, 2016 | Mar. 31, 2015 |
Liability Related to Sale of Future Royalties | |||||
Royalty revenue | $ 5,099 | $ 195 | $ 13,890 | ||
Percentage of royalty payments if applicable threshold is met | 85.00% | ||||
Immunity Royalty Holdings, L.P | |||||
Liability Related to Sale of Future Royalties | |||||
Percentage of royalty payments | 100.00% | ||||
Royalty revenue | $ 24,800 | $ 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% | ||||
Proceeds from sale of future royalties | $ 200,000 | ||||
Transaction costs incurred during royalty purchase agreement | $ 5,900 | ||||
Movement in Deferred Revenue [Roll Forward] | |||||
Liability related to sale of future royalties - beginning balance | 199,662 | ||||
Non cash Kadcyla royalty revenue | (19,355) | ||||
Non cash interest expense recognized | 14,330 | ||||
Liability related to sale of future royalties - ending balance | $ 194,637 | $ 194,637 | |||
Effective annual interest rate | 9.60% |
Capital Stock (Details)
Capital Stock (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | 142 Months Ended | |||
Mar. 31, 2016 | Mar. 31, 2015 | Mar. 31, 2016 | Mar. 31, 2015 | Jun. 30, 2015 | Jun. 30, 2014 | Mar. 31, 2016 | |
Stock-Based Compensation | |||||||
Compensation expense (expense reduction) | $ 17,668,000 | $ 12,804,000 | |||||
2001 Director Plan | Stock options | |||||||
Stock-Based Compensation | |||||||
Compensation expense (expense reduction) | $ (32,000) | $ 18,000 | $ (37,000) | (19,000) | |||
Stock units issued (in shares) | 0 | ||||||
Stock compensation expense | $ 329,000 | ||||||
Compensation Policy for Non-Employee Directors | Stock options | |||||||
Stock-Based Compensation | |||||||
Vesting period | 1 year | ||||||
Stock options granted to directors (in shares) | 80,000 | 80,000 | |||||
Compensation Policy for Non-Employee Directors | Deferred share units | |||||||
Stock-Based Compensation | |||||||
Vesting period | 1 year | ||||||
Stock compensation expense | $ 108,000 | $ 93,000 | $ 272,000 |
Commitments and Contingencies31
Commitments and Contingencies (Details) | 1 Months Ended | 9 Months Ended | ||||||
Feb. 29, 2016USD ($)ft² | Apr. 30, 2014USD ($)item | Apr. 30, 2013ft² | Mar. 31, 2015 | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2013USD ($) | Jul. 27, 2007ft² | |
Minimum rental commitments under the non-cancelable operating lease agreements | ||||||||
2016 (six months remaining) | $ 1,859,000 | |||||||
2,017 | 7,876,000 | |||||||
2,018 | 7,995,000 | |||||||
2,019 | 7,197,000 | |||||||
2,020 | 7,193,000 | |||||||
Thereafter | 41,163,000 | |||||||
Total minimum lease payments | 73,283,000 | |||||||
Total minimum rental payments from sublease | (280,000) | |||||||
Total minimum lease payments, net | 73,003,000 | |||||||
Obligations under capital leases | 0 | |||||||
Collaborations | ||||||||
Potential milestone payable | 162,000,000 | |||||||
Amount reimbursable by a third party | $ 1,400,000 | |||||||
830 Winter Street, Waltham, MA | ||||||||
Operating leases | ||||||||
Area of space leased (in square feet) | ft² | 110,000 | |||||||
Construction allowance receivable | $ 1,100,000 | $ 196,000 | $ 746,000 | |||||
Number of additional terms for which lease agreement can be extended | item | 2 | |||||||
Additional term period for which lease agreement can be extended | 5 years | |||||||
333 Providence Hwy, Norwood MA | ||||||||
Operating leases | ||||||||
Additional term period for which lease agreement can be extended | 5 years | |||||||
100 River Ridge Drive, Norwood, MA | ||||||||
Operating leases | ||||||||
Area of space leased (in square feet) | ft² | 7,507 | |||||||
Initial lease term period | 5 years 2 months | |||||||
Additional term period for which lease agreement can be extended | 5 years | |||||||
930 Winter Street, Walham, MA | ||||||||
Operating leases | ||||||||
Area of space leased (in square feet) | ft² | 10,281 | |||||||
Initial lease term period | 5 years 2 months | |||||||
Construction allowance receivable | $ 617,000,000 |