Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Oct. 30, 2018 | |
Document Information [Line Items] | ||
Entity Registrant Name | HALOZYME THERAPEUTICS INC. | |
Trading Symbol | HALO | |
Entity Central Index Key | 1,159,036 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2018 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 144,557,543 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 55,019 | $ 168,740 |
Marketable securities, available-for-sale | 309,347 | 300,474 |
Accounts receivable, net | 27,656 | 22,133 |
Inventories | 18,285 | 5,146 |
Prepaid expenses and other assets | 19,619 | 13,879 |
Total current assets | 429,926 | 510,372 |
Property and equipment, net | 6,790 | 3,520 |
Prepaid expenses and other assets | 7,291 | 5,553 |
Restricted cash | 500 | 500 |
Total assets | 444,507 | 519,945 |
Current liabilities: | ||
Accounts payable | 3,331 | 7,948 |
Accrued expenses | 43,020 | 39,601 |
Deferred revenue, current portion | 4,247 | 6,568 |
Current portion of long-term debt, net | 88,521 | 77,211 |
Total current liabilities | 139,119 | 131,328 |
Deferred revenue, net of current portion | 5,507 | 54,297 |
Long-term debt, net | 57,940 | 125,140 |
Other long-term liabilities | 2,203 | 814 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity (deficit): | ||
Preferred stock - $0.001 par value; 20,000 shares authorized; no shares issued and outstanding | 0 | 0 |
Common stock - $0.001 par value; 200,000 shares authorized; 142,301 and 129,502 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively | 145 | 143 |
Additional paid-in capital | 769,382 | 731,044 |
Accumulated other comprehensive loss | (478) | (450) |
Accumulated deficit | (529,311) | (522,371) |
Total stockholders' equity (deficit) | 239,738 | 208,366 |
Total liabilities and stockholders' equity (deficit) | $ 444,507 | $ 519,945 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares shares in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 20,000 | 20,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000 | 200,000 |
Common stock, shares issued | 144,522 | 142,789 |
Common stock, shares outstanding | 144,522 | 142,789 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenues: | ||||
Product sales, net | $ 6,269 | $ 13,589 | $ 17,553 | $ 37,803 |
Royalty Revenue | 18,710 | 17,119 | 59,643 | 45,839 |
License and Services Revenue | 577 | 33,023 | 14,434 | 43,407 |
Total revenues | 25,556 | 63,731 | 91,630 | 127,049 |
Operating expenses: | ||||
Cost of product sales | 626 | 8,332 | 4,514 | 23,664 |
Research and development | 35,540 | 33,993 | 113,602 | 109,267 |
Selling, general and administrative | 14,864 | 13,329 | 42,773 | 39,045 |
Total operating expenses | 51,030 | 55,654 | 160,889 | 171,976 |
Operating income (loss) | (25,474) | 8,077 | (69,259) | (44,927) |
Other income (expense): | ||||
Investment and other income, net | 1,910 | 790 | 5,561 | 1,512 |
Interest expense | (4,286) | (5,538) | (14,286) | (16,526) |
Income (loss) before income taxes | (27,850) | 3,329 | (77,984) | (59,941) |
Income tax expense | 0 | 580 | 220 | 970 |
Net income (loss) | $ (27,850) | $ 2,749 | $ (78,204) | $ (60,911) |
Earnings Per Share, Basic | $ (0.19) | $ 0.02 | $ (0.55) | $ (0.45) |
Earnings Per Share, Diluted | $ (0.19) | $ 0.02 | $ (0.55) | $ (0.45) |
Shares used in computing basic net income (loss) per share | 143,949 | 141,190 | 143,396 | 134,633 |
Shares used in computing diluted net income (loss) per share | 143,949 | 143,236 | 143,396 | 134,633 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Statement of Comprehensive Income [Abstract] | ||||
Net income (loss) | $ (27,850) | $ 2,749 | $ (78,204) | $ (60,911) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on marketable securities | 256 | 24 | (17) | (40) |
Foreign currency translation adjustment | 2 | 1 | (11) | (6) |
Unrealized loss on foreign currency | 0 | (17) | 0 | (1) |
Total comprehensive income (loss) | $ (27,592) | $ 2,757 | $ (78,232) | $ (60,958) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Statement of Cash Flows [Abstract] | ||
Capital Expenditures Incurred but Not yet Paid | $ 2,345 | $ 266 |
Operating activities: | ||
Net loss | (78,204) | (60,911) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 26,684 | 23,268 |
Depreciation and amortization | 1,798 | 1,668 |
Non-cash interest expense | 2,000 | 2,378 |
(Accretion of discounts) amortization of premiums on marketable securities, net | (2,166) | (94) |
Deferral of unearned revenue | 3,000 | 422 |
Recognition of deferred revenue | (2,333) | (4,192) |
Recognition of deferred rent | (78) | 125 |
Other | (10) | 38 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 13,962 | 985 |
Inventories | (13,139) | 5,292 |
Prepaid expenses and other assets | (7,477) | 8,998 |
Accounts payable and accrued expenses | (4,155) | 3,077 |
Net cash used in operating activities | (59,962) | (19,196) |
Investing activities: | ||
Purchases of marketable securities | (272,643) | (198,748) |
Proceeds from maturities of marketable securities | 265,917 | 184,494 |
Purchases of property and equipment | (1,590) | (490) |
Net cash used in investing activities | (8,316) | (14,744) |
Financing activities: | ||
Proceeds from issuance of common stock, net | 0 | 134,875 |
Repayment of long-term debt | (57,099) | (10,988) |
Proceeds from issuance of common stock under equity incentive plans, net of taxes paid related to net share settlement | 11,656 | 7,686 |
Net cash provided by financing activities | (45,443) | 131,573 |
Net increase in cash, cash equivalents and restricted cash | (113,721) | 97,633 |
Cash, cash equivalents and restricted cash beginning of period | 169,240 | 67,264 |
Cash, cash equivalents and restricted cash end of period | 55,519 | 164,897 |
Payments for Tenant Improvements | $ 1,322 | $ 0 |
Organization and Business
Organization and Business | 9 Months Ended |
Sep. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business | Organization and Business Halozyme Therapeutics, Inc. is a biotechnology company focused on developing and commercializing novel oncology therapies. We are seeking to translate our unique knowledge of the tumor microenvironment to create therapies that have the potential to improve cancer patient survival. Our research primarily focuses on human enzymes that alter the extracellular matrix and tumor microenvironment. The extracellular matrix is a complex matrix of proteins and carbohydrates surrounding the cell that provides structural support in tissues and orchestrates many important biological activities, including cell migration, signaling and survival. Over many years, we have developed unique technology and scientific expertise enabling us to pursue this target-rich environment for the development of therapies. Our proprietary enzymes are used to facilitate the delivery of injected drugs and fluids, potentially enhancing the efficacy and the convenience of other drugs or can be used to alter tissue structures for potential clinical benefit. We exploit our technology and expertise using a two pillar strategy that we believe enables us to manage risk and cost by: (1) developing our own proprietary products in therapeutic areas with significant unmet medical needs, with a focus on oncology, and (2) licensing our technology to biopharmaceutical companies to collaboratively develop products that combine our technology with the collaborators’ proprietary compounds. The majority of our approved product and product candidates are based on rHuPH20, our patented recombinant human hyaluronidase enzyme. rHuPH20 is the active ingredient in our first commercially approved product, Hylenex ® recombinant, and it works by temporarily breaking down hyaluronan (or “HA”), a naturally occurring carbohydrate that is a major component of the extracellular matrix in tissues throughout the body such as skin and cartilage. We believe this temporary degradation creates an opportunistic window for the improved subcutaneous delivery of injectable biologics, such as monoclonal antibodies and other large therapeutic molecules, as well as small molecules and fluids. We refer to the application of rHuPH20 to facilitate the delivery of other drugs or fluids as our ENHANZE ® Drug Delivery Technology (“ENHANZE”). We license the ENHANZE technology to form collaborations with biopharmaceutical companies that develop or market drugs requiring or benefiting from injection via the subcutaneous route of administration. We currently have ENHANZE collaborations with F. Hoffmann-La Roche, Ltd. and Hoffmann-La Roche, Inc. (“Roche”), Baxalta US Inc. and Baxalta GmbH (Baxalta Incorporated was acquired by Shire plc in June 2016) (“Baxalta”), Pfizer Inc. (“Pfizer”), Janssen Biotech, Inc. (“Janssen”), AbbVie, Inc. (“AbbVie”), Eli Lilly and Company (“Lilly”), Bristol-Myers Squibb Company (“BMS”) and Alexion Pharma Holding (“Alexion”).We receive royalties from two of these collaborations, including royalties from sales of one product from the Baxalta collaboration and two products from the Roche collaboration. Future potential revenues from the sales and/or royalties of our approved products, product candidates, and ENHANZE collaborations will depend on the ability of Halozyme and our collaborators to develop, manufacture, secure and maintain regulatory approvals for approved products and product candidates and commercialize product candidates. Our proprietary development pipeline consists primarily of pre-clinical and clinical stage product candidates in oncology. Our lead oncology program is Pegvorhyaluronidase alfa (PVHA), also referred to as PEGylated recombinant human hyaluronidase (“PEGPH20”), a molecular entity we are developing in combination with currently approved cancer therapies as a candidate for the systemic treatment of tumors that accumulate HA. We have demonstrated that when HA accumulates in a tumor, it can cause increased pressure in the tumor, reducing blood flow into the tumor and with that, reduced access of cancer therapies to the tumor. PEGPH20 has been demonstrated in animal models to work by temporarily degrading HA surrounding cancer cells resulting in reduced pressure and increased blood flow to the tumor thereby enabling increased amounts of anticancer treatments administered concomitantly gaining access to the tumor. Through our efforts and efforts of our partners and collaborators, we are currently in Phase 3 clinical testing for PEGPH20 with ABRAXANE ® (nab-paclitaxel) and gemcitabine in stage IV pancreatic ductal adenocarcinoma (“PDA”) (HALO 109-301), in Phase 1b clinical testing for PEGPH20 with KEYTRUDA ® (pembrolizumab) in non-small cell lung cancer and gastric cancer (HALO 107-101), in Phase 1b/2 clinical testing for PEGPH20 with Tecentriq® (atezolizumab) in patients with previously treated metastatic PDA, in Phase 1b/2 clinical testing for PEGPH20 with Tecentriq in patients with gastric cancer and in Phase 1b/2 clinical testing for PEGPH20 with Tecentriq in patients with cholangiocarcinoma and gall bladder cancer (HALO 110-101/MATRIX). Except where specifically noted or the context otherwise requires, references to “Halozyme,” “the Company,” “we,” “our,” and “us” in these notes to condensed consolidated financial statements refer to Halozyme Therapeutics, Inc. and its wholly owned subsidiary, Halozyme, Inc., and Halozyme, Inc.’s wholly owned subsidiaries, Halozyme Holdings Ltd., Halozyme Royalty LLC, Halozyme Switzerland GmbH and Halozyme Switzerland Holdings GmbH. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) related to a quarterly report on Form 10-Q. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for a complete set of financial statements. These interim unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2017 , filed with the SEC on February 20, 2018. The unaudited financial information for the interim periods presented herein reflects all adjustments which, in the opinion of management, are necessary for a fair presentation of the financial condition and results of operations for the periods presented, with such adjustments consisting only of normal recurring adjustments. Certain reclassifications have been made to the prior period condensed consolidated statement of cash flows within operating activities to conform to the current period presentation. There was no change to net cash used in operating activities. Operating results for interim periods are not necessarily indicative of the operating results for an entire fiscal year. The accompanying condensed consolidated financial statements include the accounts of Halozyme Therapeutics, Inc. and our wholly owned subsidiary, Halozyme, Inc., and Halozyme, Inc.’s wholly owned subsidiaries, Halozyme Holdings Ltd., Halozyme Royalty LLC, Halozyme Switzerland GmbH and Halozyme Switzerland Holdings GmbH. All intercompany accounts and transactions have been eliminated. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates. Cash Equivalents and Marketable Securities Cash equivalents consist of highly liquid investments, readily convertible to cash, that mature within ninety days or less from the date of purchase. As of September 30, 2018 , our cash equivalents consisted of money market funds and commercial paper. Marketable securities are investments with original maturities of more than ninety days from the date of purchase that are specifically identified to fund current operations. Marketable securities are considered available-for-sale. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date which reflects management’s intention to use the proceeds from the sale of these investments to fund our operations, as necessary. Such available-for-sale investments are carried at fair value with unrealized gains and losses recorded in other comprehensive gain (loss) and included as a separate component of stockholders’ equity (deficit). The cost of marketable securities is adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion is included in investment and other income, net in the condensed consolidated statements of operations. We use the specific identification method for calculating realized gains and losses on marketable securities sold. Realized gains and losses and declines in value judged to be other-than-temporary on marketable securities, if any, are included in investment and other income, net in the consolidated statements of operations. Restricted Cash Under the terms of the leases of our facilities, we are required to maintain letters of credit as security deposits during the terms of such leases. At September 30, 2018 and December 31, 2017 , restricted cash of $0.5 million was pledged as collateral for the letters of credit. Fair Value of Financial Instruments The authoritative guidance for fair value measurements establishes a three tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. Our financial instruments include cash equivalents, available-for-sale marketable securities, accounts receivable, prepaid expenses and other assets, accounts payable, accrued expenses and long-term debt. Fair value estimates of these instruments are made at a specific point in time, based on relevant market information. These estimates may be subjective in nature and involve uncertainties and matters of significant judgment and therefore cannot be determined with precision. The carrying amount of cash equivalents, accounts receivable, prepaid expenses and other assets, accounts payable and accrued expenses are generally considered to be representative of their respective fair values because of the short-term nature of those instruments. Based on Level 3 inputs and the borrowing rates currently available for loans with similar terms, we believe the fair value of long-term debt approximates its carrying value. Available-for-sale marketable securities consist of asset-backed securities, corporate debt securities, U.S. Treasury securities and commercial paper, and are measured at fair value using Level 1 and Level 2 inputs. Level 2 financial instruments are valued using market prices on less active markets and proprietary pricing valuation models with observable inputs, including interest rates, yield curves, maturity dates, issue dates, settlement dates, reported trades, broker-dealer quotes, issue spreads, benchmark securities or other market related data. We obtain the fair value of Level 2 investments from our investment manager, who obtains these fair values from a third-party pricing source. We validate the fair values of Level 2 financial instruments provided by our investment manager by comparing these fair values to a third-party pricing source. Inventories Inventories are stated at lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Inventories are reviewed periodically for potential excess, dated or obsolete status. We evaluate the carrying value of inventories on a regular basis, taking into account such factors as historical and anticipated future sales compared to quantities on hand, the price we expect to obtain for products in their respective markets compared with historical cost and the remaining shelf life of goods on hand. We capitalize inventory costs associated with our drug candidates prior to receipt of regulatory approval, based on management’s judgment of probable future commercialization. We would be required to expense these capitalized costs upon a change in such judgment, due to, among other factors, a decision denying approval of the drug candidate by regulatory agencies. Bulk rHuPH20 formulations manufactured for partner use prior to our partner receiving marketing approval from the U.S. Food and Drug Administration (“FDA”) or comparable regulatory agencies in foreign countries and with no alternative future use are recorded as research and development expense. All direct manufacturing costs incurred after the partner receives marketing approval are capitalized as inventory. Bulk rHuPH20 formulations manufactured for general partner and internal use, which can potentially be used by any collaboration partner or by us in any stage of development or in commercial product, and ENHANZE drug product used by our partners in clinical trials, is considered to have alternative future use and all manufacturing costs are capitalized as inventory. Inventories used in our clinical trials are expensed at the time the inventories are packaged for the clinical trials. As of September 30, 2018 and December 31, 2017 , inventories consisted of $2.4 million and $2.9 million , respectively, of Hylenex recombinant inventory, net and $15.9 million and $2.2 million , respectively, of bulk rHuPH20. Revenue Recognition We generate revenues from payments received under collaborative agreements and product sales. As of January 1, 2018, we adopted ASC 606, Revenue from Contracts with Customers (ASC 606) which affects how we recognize revenues in these arrangements. We applied the provisions of ASC 606 using the modified retrospective approach, with the cumulative effect of the adoption recognized as of January 1, 2018, to all contracts that had not been completed as of that date. Under ASC 606, we recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the promised goods or services in the contract; (ii) identify the performance obligations in the contract, including whether they are distinct in the context of the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligations. Amounts reported in prior periods have not been adjusted. Accordingly, the reported revenue amounts for the three and nine months ended September 30, 2018 and 2017 are based on different accounting policies. Prior to the ASC 606 adoption, revenue was recognized when all of the following criteria were met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the seller’s price to the buyer is fixed or determinable; and (4) collectibility is reasonably assured. Differences between the revenue recognition policies applicable prior to the adoption and ASC 606 are described in the following sections and in Note 4. Revenues under Collaborative Agreements - as reported under ASC 606 beginning January 1, 2018 Under these agreements, we grant the collaboration partner a worldwide license to develop and commercialize products using our ENHANZE technology to combine our patented rHuPH20 enzyme with their proprietary biologics directed at up to a specified number of targets. Targets are usually licensed on an exclusive, global basis. Targets selected subsequent to inception of the arrangement require payment of an additional license fee. The collaboration partner is responsible for all development, manufacturing, clinical, regulatory, sales and marketing costs for any products developed under the agreement. We are responsible for supply of bulk rHuPH20 based on the collaboration partner’s purchase orders, and may also be separately engaged to perform research and development services. We collect an upfront license payment from the collaboration partner, and are also entitled to receive event-based payments subject to the collaboration partner’s achievement of specified development, regulatory and sales-based milestones. In several agreements, collaboration partners pay us annual fees to maintain their exclusive license rights if they are unable to advance product development to specified stages. We earn separate fees for bulk rHuPH20 supplies and research and development services. In addition, the collaboration partner will pay us royalties at an on average mid-single digit percent rate of their sales if products under the collaboration are commercialized. All amounts owed to us are noncancelable after the underlying triggering event occurs, and nonrefundable once paid. Unless terminated earlier in accordance with its terms, the collaboration continues in effect until the later of: (i) expiration of the last to expire of the valid claims of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers a product developed under the collaboration, and (ii) expiration of the last to expire royalty term for a product developed under the collaboration, which is determined separately for each country. In the event such valid claims expire prior to the last to expire royalty term, the royalty rate is reduced for the remaining royalty term following such expiration. The collaboration partner may terminate the agreement prior to expiration for any reason in its entirety or on a target-by-target basis generally upon 90 days prior written notice to us. Upon any such termination, the license granted to the collaboration partner (in total or with respect to the terminated target, as applicable) will terminate provided, however, that in the event of expiration of the agreement, the licenses granted will become perpetual, non-exclusive and fully paid. Although these agreements are in form structured as collaborative agreements, we concluded for accounting purposes they represent contracts with customers, and are not subject to accounting literature on collaborative arrangements. This is because we grant to collaboration partners licenses to our intellectual property, and provide supply of bulk rHuPH20 and research and development services which are all outputs of our ongoing activities, in exchange for consideration. We do not develop assets jointly with collaboration partners, and do not share in significant risks of their development or commercialization activities. Accordingly, we concluded our collaborative agreements must be accounted for pursuant to ASC Topic 606, Revenue from Contracts with Customers. Under all of our collaborative agreements, we have identified licenses to use functional intellectual property as the only performance obligation. The intellectual property underlying the license is our proprietary ENHANZE ® technology which represents application of rHuPH20 to facilitate delivery of drugs or fluids. The license grants the collaboration partners right to use our intellectual property as it exists on the effective date of the license, because there is no ongoing development of the ENHANZE technology required. Therefore, we recognize revenue from licenses at the point when the license becomes effective and the collaboration partner has received access to our intellectual property, usually at the inception of the agreement. When collaboration partners can select additional targets to add to the licenses granted, we consider these rights to be options. We evaluate whether such options contain material rights, i.e. have exercise prices that are discounted compared to what we would charge for a similar license to a new collaboration partner. The exercise price of these options includes a combination of the target selection fees, event-based milestone payments and royalties. When these amounts in aggregate are not offered at a discount that exceeds discounts available to other customers, we conclude the option does not contain a material right, and we consider grants of additional licensing rights upon option exercises to be separate contracts (target selection contracts). We provide standard indemnification and protection of licensed intellectual property for our customers. These provisions are part of assurance that the licenses meet the agreements representations and are not obligations to provide goods or services. We also fulfill purchase orders for supply of bulk rHuPH20 and perform research and development services pursuant to projects authorization forms for our collaboration partners, which represent separate contracts. Additionally, we price our supply of bulk rHuPH20 and research and development services at our regular selling prices, called standalone selling price or SSP. Therefore, our collaboration partners do not have material rights to order these items at prices not reflective of SSP. Refer to the discussion below regarding recognition of revenue for these separate contracts. Transaction price for a contract represents the amount to which we are entitled in exchange for providing goods and services to the customer. Transaction price does not include amounts subject to uncertainties unless it is probable that there will be no significant reversal of revenue when the uncertainty is resolved. Apart from the upfront license payment (or target selection fees in the target selection contracts), all other fees we may earn under our collaborative agreements are subject to significant uncertainties of product development. Achievement of many of the event-based development and regulatory milestones may not be probable until such milestones are actually achieved. This generally relates to milestones such as obtaining marketing authorization approvals and successful completion of clinical trials. With respect to other development milestones, e.g. dosing of a first patient in a clinical trial, achievement could be considered probable prior to its actual occurrence, based on the progress towards commencement of the trial. We do not include any amounts subject to uncertainties into the transaction price until it is probable that the amount will not result in a significant reversal of revenue in the future. At the end of each reporting period, we re-evaluate the probability of achievement of such milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. When target exchange rights are held by collaboration partners, and the amounts attributed to these rights are not refundable, they are included in the transaction price. However, they are recorded as deferred revenues because we have a potential performance obligation to provide a new target if the exchange right is exercised. These amounts are recognized in revenue when the right of exchange expires or is exercised. Because our agreements only have one type of performance obligation (licenses) which are typically all transferred at the same time at agreement inception, allocation of transaction price often is not required. However, allocation is required when licenses for some of the individual targets are subject to rights of exchange, because revenue associated with these targets cannot be recognized. We perform an allocation of the upfront amount based on relative SSP of licenses for individual targets. We determine license SSP using income-based valuation approach utilizing risk-adjusted discounted cash flow projections of the estimated return a licensor would receive. When amounts subject to uncertainties, such as milestones and royalties, are included in the transaction price, we attribute them to the specific individual target licenses which generate such milestone or royalty amounts. We also estimate SSP of bulk rHuPH20 and research and development services, to determine that our collaboration partners do not have material rights to order them at discounted prices. For supplies of bulk rHuPH20, because we effectively act as a contract manufacturer to our collaboration partners, we estimate and charge SSP based on the typical contract manufacturer margins consistently with all of our collaborative partners. We determine SSP of research and development services based on a fully-burdened labor rate. Our rates are comparable to those we observe in other collaborative agreements. We also have a history of charging similar rates to all of our collaboration partners. Upfront amounts allocated to licenses to individual targets are recognized as revenue when the license is transferred to the collaboration partner, as discussed above, if the license is not subject to exchange rights, or when the exchange right expires or is exercised. Development milestones and other fees are recognized in revenue when they are included in the transaction price, because by that time we have already transferred the related license to the collaboration partner. Sales-based milestones and royalties cannot be recognized until the underlying sales occur. We do not receive final royalty reports from our collaboration partners until after we complete our financial statements for a prior quarter. Therefore, we recognize revenue based on estimates of the royalty earned, which are based on preliminary reports provided by our collaboration partners. We will record a true-up in the following quarter if necessary, when final royalty reports are received. To date, we have not recorded any material true-ups. In contracts to provide research and development services, such services represent the only performance obligation. The fees are charged based on hours worked by our employees and the fixed contractual rate per hour, plus third-party pass-through costs, on a monthly basis. We recognize revenues as the related services are performed based on the amounts billed, as the collaboration partner consumes the benefit of research and development work simultaneously as we perform these services, and the amounts billed reflect the value of these services to the customer. Refer to Note 4 Revenue , for further discussion on our collaborative arrangements. Prior to the adoption of ASC 606 on January 1, 2018, we recognized upfront amounts received under two of our collaborative agreements straight-line over the contract term in accordance with the accounting standards that were in effect in 2006-2007, when these collaborative agreements were entered into. In addition, we recognized royalty revenue in the period when we received final royalty reports from the collaboration partners, in the quarter following the quarter in which the corresponding sales occurred. There were no other differences in revenue to be recognized under the previously existing authoritative accounting literature and ASC 606 applied to our collaborative agreements. Product Sales, Net - as reported under ASC 606 beginning January 1, 2018 Hylenex Recombinant We sell Hylenex recombinant in the U.S. to wholesale pharmaceutical distributors, who sell the product to hospitals and other end-user customers. Sales to wholesalers are made pursuant to purchase orders subject to the terms of a master agreement, and delivery of individual packages of Hylenex recombinant represent performance obligations under each purchase order. We use a contract manufacturer to produce Hylenex recombinant and a third-party logistics (3PL) vendor to process and fulfill orders . We concluded we are the principal in the sales to wholesalers because we control access to services rendered by both vendors and direct their activities. We have no significant obligations to wholesalers to generate pull-through sales. Selling prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks when wholesalers sell Hylenex recombinant at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”) and government programs. We also pay quarterly distribution fees to certain wholesalers for inventory reporting and chargeback processing, and to GPOs for access to GPO members. We concluded the benefits received in exchange for these fees are not distinct from our sales of Hylenex recombinant, and accordingly we apply these amounts to reduce revenues. Wholesalers also have rights to return unsold product nearing or past the expiration date. Because of the shelf life of Hylenex recombinant and our lengthy return period, there may be a significant period of time between when the product is shipped and when we issue credits on returned product. We estimate the transaction price when we receive each purchase order taking into account the expected reductions of the selling price initially billed to the wholesaler arising from all of the above factors. We have compiled historical experience and data to estimate future returns and chargebacks of Hylenex recombinant and the impact of the other discounts and fees we pay. When estimating these adjustments to the transaction price, we reduce it sufficiently to be able to assert that it is probable that there will be no significant reversal of revenue when the ultimate adjustment amounts are known. Each purchase order contains only one type of product, and is usually shipped to the wholesaler in a single shipment. Therefore, allocation of the transaction price to individual packages is not required. We recognize revenue from Hylenex recombinant product sales and related cost of sales upon product delivery to the wholesaler location. At that time, the wholesalers take control of the product as they take title, bear the risk of loss of ownership, and have an enforceable obligation to pay us. They also have the ability to direct sales of product to their customers on terms and at prices they negotiate. Although wholesalers have product return rights, we do not believe they have a significant incentive to return the product to us. Upon recognition of revenue from product sales of Hylenex recombinant, the estimated amounts of credit for product returns, chargebacks, distribution fees, prompt payment discounts, and GPO fees are included in sales reserves, accrued liabilities and net of accounts receivable. We monitor actual product returns, chargebacks, discounts and fees subsequent to the sale. If these amounts differ from our estimates, we make adjustments to these allowances, which are applied to increase or reduce product sales revenue and earnings in the period of adjustments. In connection with the orders placed by wholesalers, we incur costs such as commissions to our sales representatives. However, as revenue from product sales is recognized upon delivery to the wholesaler, which occurs shortly after we receive a purchase order, we do not capitalize these commissions and other costs, based on application of a practical expedient allowed in ASC 606. Bulk rHuPH20 We sell bulk rHuPH20 to collaboration partners for use in research and development; subsequent to receiving marketing approval, we sell it for use in collaboration commercial products. Sales are made pursuant to purchase orders subject to the terms of the collaborative agreement, and delivery of units of bulk rHuPH20 represent performance obligations under each purchase order. We provide a standard warranty that the product conforms to specifications. We use a contract manufacturer to produce bulk rHuPH20 and have concluded we are the principal in the sales to collaboration partners. The transaction price for each purchase order of bulk rHuPH20 is fixed based on the cost of production plus a contractual markup, and is not subject to adjustments. Allocation of the transaction price to individual quantities of the product is usually not required because each order contains only one type of product. We recognize revenue from bulk rHuPH20 formulations as product sales and related cost of sales upon transfer of title to our partners. At that time, the partners take control of the product, bear the risk of loss of ownership, and have an enforceable obligation to pay us. There were no differences in how the previously existing authoritative accounting literature applied to our product sales transactions. ENHANZE Drug Product We sell ENHANZE drug product to collaboration partners for use in research and development in early phase clinical studies. Sales are made pursuant to purchase orders subject to the terms of the collaborative agreement, and delivery of units of ENHANZE drug product represent performance obligations under each purchase order. We provide a standard warranty that the product conforms to specifications. We use a contract manufacturer to produce ENHANZE drug product and we concluded we are the principal in the sales to collaboration partners. The transaction price for each purchase order of ENHANZE drug product is fixed based on the cost of production plus a contractual markup, and is not subject to adjustments. Allocation of the transaction price to individual quantities of the product is usually not required because each order contains only one type of product. We recognize revenue from ENHANZE drug product as product sales and related cost of sales upon transfer of title to our partners. At that time, the partners take control of the product, bear the risk of loss of ownership, and have an enforceable obligation to pay us. There were no differences in how the previously existing authoritative accounting literature applied to our product sales transactions. Revenue Presentation In our statements of operations, we report as revenues under collaborative agreements the upfront payments, event-based development and regulatory milestones and sales milestones. We also include in this category revenues from separate research and development contracts pursuant to project authorization forms and sales of bulk rHuPH20 that has no alternative future use. We report royalties received from collaboration partners as a separate line in our statements of operations. Revenues from sales of Hylenex recombinant, bulk rHuPH20 that has alternative future use and ENHANZE drug product are included in product sales, net. In footnotes to our financial statements, we provide disaggregated revenue information by type of arrangement (product sales, net, collaborative agreements and research and development services), and additionally, by type of payment stream received under collaborative agreements (upfront amounts, event-based development and regulatory milestones and other fees, sales milestones and royalties). Cost of Product Sales Cost of product sales consists primarily of raw materials, third-party manufacturing costs, fill and finish costs, freight costs, internal costs and manufacturing overhead associated with the production of Hylenex recombinant and bulk rHuPH20 and ENHANZE drug product that has alternative future use. Cost of product sales also consists of the write-down of excess, dated and obsolete inventories and the write-off of inventories that do not meet certain product specifications, if any. Prior to bulk rHuPH20 and ENHANZE drug product having alternative future use, all costs related to the manufacturing of those products were charged to research and development expenses in the periods such costs were incurred. During the three and nine months ended September 30, 2018 , sales of bulk rHuPH20 and ENHANZE drug product included $1.7 million and $2.3 million , respectively, of cost of sales that were previously expensed as research and development. Of the bulk rHuPH20 and ENHANZE drug product that has alternative future use on hand as of September 30, 2018 , approximately $2.0 million in manufacturing costs were previously recorded as research and development expenses. We expect to sell this inventory by the end of 2020. Research and Development Expenses Research and development expenses include salaries and benefits, facilities and other overhead expenses, external clinical trial expenses, research related manufacturing services, contract services and other outside expenses. Research and development expenses are charged to operating expenses as incurred when these expenditures relate to our research and development efforts and have no alternative future uses. When bulk rHuPH20 is manufactured for use in research and development by us or our partners and the product cannot be redirected for alternative use due to formulation and manufacturing specifications, the manufacturing costs are recorded as research and development expense. Bulk rHuPH20 that is manufactured for partner use prior to our partner receiving marketing approval from the FDA or comparable regulatory agencies in foreign countries and meet these specifications is recorded as research and development expenses. The manufacturing costs of bulk rHuPH20 for the approved collaboration products, Herceptin SC, MabThera SC (RITUXAN HYCELA™ in the U.S.) and HYQVIA, incurred after the receipt of marketing a |
Fair Value Measurement (Notes)
Fair Value Measurement (Notes) | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosures [Text Block] | Fair Value Measurement Available-for-sale marketable securities consisted of the following (in thousands): September 30, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Asset-backed securities $ 39,721 $ — $ (24 ) $ 39,697 Corporate debt securities 74,699 — (181 ) 74,518 U.S. Treasury securities 99,716 — (248 ) 99,468 Commercial paper 95,664 — — 95,664 $ 309,800 $ — $ (453 ) $ 309,347 December 31, 2017 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate debt securities $ 117,427 $ — $ (235 ) $ 117,192 U.S. Treasury securities 66,601 — (201 ) 66,400 Commercial paper 116,882 — — 116,882 $ 300,910 $ — $ (436 ) $ 300,474 As of September 30, 2018 , all of our available-for-sale debt securities were scheduled to mature within the next 12 months and 27 available-for-sale marketable securities were in a gross unrealized loss position, all of which had been in such position for less than 12 months. Based on our review of these marketable securities, we believe we had no other than-temporary impairments on these securities as of September 30, 2018 , because we do not intend to sell these securities and it is not more-likely-than-not that we will be required to sell these securities before the recovery of their amortized cost basis. The following table summarizes, by major security type, our cash equivalents and available-for-sale marketable securities that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands): September 30, 2018 December 31, 2017 Level 1 Level 2 Total estimated fair value Level 1 Level 2 Total estimated fair value Cash equivalents: Money market funds $ 55,271 $ — $ 55,271 $ 142,091 $ — $ 142,091 Commercial paper — — — — 15,700 15,700 Available-for-sale marketable securities: Asset-backed securities — 39,697 39,697 — — — Corporate debt securities — 74,518 74,518 — 117,192 117,192 U.S. Treasury securities 99,468 — 99,468 66,400 — 66,400 Commercial paper — 95,664 95,664 — 116,882 116,882 $ 154,739 $ 209,879 $ 364,618 $ 208,491 $ 249,774 $ 458,265 There were no transfers between Level 1 and Level 2 of the fair value hierarchy during the nine months ended September 30, 2018 . We had no instruments that were classified within Level 3 as of September 30, 2018 and December 31, 2017 . |
Revenue (Notes)
Revenue (Notes) | 9 Months Ended |
Sep. 30, 2018 | |
Deferred Revenue Disclosure [Abstract] | |
Collaborative Agreements | Our disaggregated revenues were as follows (in thousands): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Royalties $ 18,710 $ 17,119 $ 59,643 $ 45,839 Product sales, net Sales of bulk rHuPH20 $ 2,402 $ 9,748 $ 6,350 $ 26,825 Sales of ENHANZE drug product 186 — 322 — Sales of Hylenex 3,681 3,841 10,881 10,978 Total product sales, net 6,269 13,589 17,553 37,803 Revenues under collaborative agreements: Upfront license fees — 30,352 1,336 31,054 Event-based development milestones and other fees — 329 11,000 988 Sales-based milestones — 342 — 1,028 Research and development services 577 2,000 2,098 10,337 Total revenues under collaborative agreements 577 33,023 14,434 43,407 Total revenue $ 25,556 $ 63,731 $ 91,630 $ 127,049 During the three months ended September 30, 2018 we recognized revenue related to licenses granted to collaboration partners in prior periods in the amount of $18.7 million . This amount represents royalties earned in the current period. We recognized revenue of $0.5 million during the three months ended September 30, 2018 that had been included in deferred revenues at December 31, 2017. We did not recognize any adjustments to reduce sales reserves and allowances liability related to Hylenex recombinant sales in prior periods. During the nine months ended September 30, 2018 we recognized revenue related to licenses granted to collaboration partners in prior periods in the amount of $70.6 million . This amount represents royalties earned in the current period, development milestones of $1.0 million from Roche and $5.0 million from Alexion, and $5.0 million of variable consideration in the contract where uncertainties have been resolved and the development milestone is expected to be achieved. We also recognized revenue of $2.3 million during the nine months ended September 30, 2018 that had been included in deferred revenues at December 31, 2017. We did not recognize any adjustments to reduce sales reserves and allowances liability related to Hylenex recombinant sales in prior periods. Revenue recognized during the three and nine months ended September 30, 2017 was determined in accordance with the accounting rules applicable prior to the adoption of ASC 606 on January 1, 2018. Upon the adoption of ASC 606, we recognized an adjustment to increase our accounts receivable by $19.4 million , decrease deferred revenues by $51.8 million , and decrease accumulated deficit by $71.2 million . The impact of applying the provisions of ASC 606 in the three and nine months ended September 30, 2018 was to decrease revenues by $6.4 million and to increase revenues by $2.6 million , respectively. Under the previously existing authoritative accounting literature, at September 30, 2018 our accounts receivable and other contract assets would have been $18.7 million lower, and our deferred revenue $48.7 million higher, than the amounts reported in our condensed consolidated balance sheet. ASC 606 did not have an aggregate impact on our net cash used in operating activities, but resulted in offsetting changes in net loss and certain assets and liabilities within net cash used in operating activities in the condensed consolidated statement of cash flows. Accounts receivable, net, other contract assets and deferred revenues (contract liabilities) from contracts with customers, including collaboration partners, consisted of the following (in thousands): September 30, 2018 December 31, 2017 Accounts receivable, net $ 22,656 $ 22,133 Other contract assets 5,000 — Deferred revenues 9,754 60,865 As of September 30, 2018 , the amounts included in the transaction price of our contracts with customers, including collaboration partners, and allocated to goods and services not yet provided were $9.8 million . This amount has been collected and is reported as deferred revenues. Of the total deferred revenues, $3.0 million represents pre-payment of bulk rHuPH20 that we estimate will be delivered in 2019. Of the remaining deferred revenues, for which the timing of when these goods and services will be provided is controlled by our customers, $4.5 million can be used by the customers at any time through 2022 and the remaining $2.3 million at any time through 2019. We recognized contract assets of $5.0 million related to collaborative agreements as of September 30, 2018 , for amounts considered probable to receive for development milestones that relate to intellectual property licenses granted to collaboration partners in prior periods. The following table presents amounts under our collaborative agreements included in the transaction price (i.e. cumulative amounts triggered or probable) as of September 30, 2018 (in thousands): Upfront (1) Development (2) Sales (3) Royalty Total Collaboration partner and agreement date: Roche (December 2006 and September 2017) $ 70,000 $ 25,000 $ 22,000 $ 211,613 $ 328,613 Baxalta (September 2007) 10,000 3,000 9,000 22,438 44,438 Pfizer (December 2012) 14,500 2,000 — — 16,500 Janssen (December 2014) 15,250 15,000 — — 30,250 AbbVie (June 2015) 23,000 6,000 — — 29,000 Lilly (December 2015) 33,000 — — — 33,000 BMS (September 2017) 105,000 5,000 — — 110,000 Alexion (December 2017) 40,000 5,000 — — 45,000 (1) Upfront and additional target selection fees (2) Event-based development and regulatory milestone amounts and other fees (3) Sales-based milestone amounts Through September 30, 2018 , our collaboration partners have completed development, obtained marketing authorization approvals for certain indications and commenced commercialization of the following products: • Roche, for Herceptin SC in the European Union (“EU”) in August 2013; and MabThera SC in the EU in March 2014 and its equivalent RITUXAN HYCELA™ in the US in June 2017; and Herceptin SC in Canada in September 2018; • Baxalta, for HYQVIA in the EU and in the US in May 2013. The remaining targets and products are currently in the process of development by the collaboration partners. |
Certain Balance Sheet Items (No
Certain Balance Sheet Items (Notes) | 9 Months Ended |
Sep. 30, 2018 | |
Balance Sheet Related Disclosures [Abstract] | |
Certain Balance Sheet Items | Certain Balance Sheet Items Accounts receivable, net and other contract assets consisted of the following (in thousands): September 30, December 31, Accounts receivable from product sales to collaborators $ 1,980 $ 18,475 Accounts receivable from revenues under collaborative agreements 451 2,142 Accounts receivable from royalty payments 18,777 — Accounts receivable from other product sales 1,949 2,075 Other contract assets 5,000 — Subtotal 28,157 22,692 Allowance for distribution fees and discounts (501 ) (559 ) Total accounts receivable, net and other contract assets $ 27,656 $ 22,133 Inventories consisted of the following (in thousands): September 30, December 31, Raw materials $ 625 $ 377 Work-in-process 15,401 2,131 Finished goods 2,259 2,638 Total inventories $ 18,285 $ 5,146 Prepaid expenses and other assets consisted of the following (in thousands): September 30, December 31, Prepaid manufacturing expenses $ 8,844 $ 2,337 Prepaid research and development expenses 9,195 7,793 Other prepaid expenses 2,344 2,585 Other assets 6,527 6,717 Total prepaid expenses and other assets 26,910 19,432 Less long-term portion 7,291 5,553 Total prepaid expenses and other assets, current $ 19,619 $ 13,879 Prepaid manufacturing expenses include raw materials, slot reservation fees and other amounts paid to contract manufacturing organizations. Such amounts are reclassified to work-in-process inventory as materials are used or the CMO services are complete. Property and equipment, net consisted of the following (in thousands): September 30, December 31, Research equipment $ 9,528 $ 9,268 Manufacturing equipment 3,979 1,702 Computer and office equipment 4,811 3,725 Leasehold improvements 4,160 2,715 Subtotal 22,478 17,410 Accumulated depreciation and amortization (15,688 ) (13,890 ) Property and equipment, net $ 6,790 $ 3,520 Depreciation and amortization expense totaled $0.6 million and $0.5 million for the three months ended September 30, 2018 and 2017 , and $1.8 million and $1.7 million for the nine months ended September 30, 2018 and 2017 , respectively. Accrued expenses consisted of the following (in thousands): September 30, December 31, Accrued outsourced research and development expenses $ 19,786 $ 18,757 Accrued compensation and payroll taxes 12,914 13,384 Accrued outsourced manufacturing expenses 4,743 2,504 Other accrued expenses 6,142 5,396 Total accrued expenses 43,585 40,041 Less long-term portion 565 440 Total accrued expenses, current $ 43,020 $ 39,601 Deferred revenue consisted of the following (in thousands): September 30, December 31, Collaborative agreements License fees and event-based payments: Roche $ — $ 39,379 Other 2,265 15,999 Total license fees and event-based payments 2,265 55,378 Product sales 7,489 5,487 Total deferred revenue 9,754 60,865 Less current portion 4,247 6,568 Deferred revenue, net of current portion $ 5,507 $ 54,297 |
Long-Term Debt, Net (Notes)
Long-Term Debt, Net (Notes) | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
Long-term Debt | Long-Term Debt, Net Royalty-backed Loan In January 2016 , through our wholly-owned subsidiary Halozyme Royalty LLC (“Halozyme Royalty”), we received a $150 million loan (the “Royalty-backed Loan”) pursuant to a credit agreement (the “Credit Agreement”) with BioPharma Credit Investments IV Sub, LP and Athyrium Opportunities II Acquisition LP (the “Royalty-backed Lenders”). Under the terms of the Credit Agreement, Halozyme Therapeutics, Inc. transferred to Halozyme Royalty the right to receive royalty payments from the commercial sales of ENHANZE products owed under the Roche Collaboration and Baxalta Collaboration (“Collaboration Agreements”). The royalty payments from the Collaboration Agreements will be used to repay the principal and interest on the loan (the “Royalty Payments”). The Royalty-backed Loan bears interest at a per annum rate of 8.75% plus the three-month LIBOR rate . The three-month LIBOR rate is subject to a floor of 0.7% and a cap of 1.5% . The interest rate as of September 30, 2018 was 10.25% . The Credit Agreement provides that none of the Royalty Payments were required to be applied to the Royalty-backed Loan prior to January 1, 2017, 50% of the Royalty Payments are required to be applied to the Royalty-backed Loan between January 1, 2017 and January 1, 2018 and thereafter all Royalty Payments must be applied to the Royalty-backed Loan. However, the amounts available to repay the Royalty-backed Loan are subject to caps of $13.75 million per quarter in 2017, $18.75 million per quarter in 2018, $21.25 million per quarter in 2019 and $22.5 million per quarter in 2020 and thereafter. Amounts available to repay the Royalty-backed Loan will be applied first to pay interest and second to repay principal on the Royalty-backed Loan. Any accrued interest that is not paid on any applicable quarterly payment date, as defined, will be capitalized and added to the principal balance of the Royalty-backed Loan on such date. Halozyme Royalty will be entitled to receive and distribute to Halozyme any Royalty Payments that are not required to be applied to the Royalty-backed Loan or which are in excess of the foregoing caps. Because the repayment of the term loan is contingent upon the level of Royalty Payments received, the repayment term may be shortened or extended depending on the actual level of Royalty Payments. The final maturity date of the Royalty-backed Loan will be the earlier of (i) the date when principal and interest is paid in full, (ii) the termination of Halozyme Royalty’s right to receive royalties under the Collaboration Agreements, and (iii) December 31, 2050 . Currently, we estimate that the loan will be repaid in the first quarter of 2020. This estimate could be adversely affected and the repayment period could be extended if future royalty amounts are less than currently expected. Under the terms of the Credit Agreement, at any time after January 1, 2019, Halozyme Royalty may, subject to certain limitations, prepay the outstanding principal of the Royalty-backed Loan in whole or in part, at a price equal to 105% of the outstanding principal on the Royalty-backed Loan, plus accrued but unpaid interest. The Royalty-backed Loan constitutes an obligation of Halozyme Royalty, and is non-recourse to Halozyme. Halozyme Royalty retains its right to the Royalty Payments following repayment of the loan. As of September 30, 2018 , we were in compliance with all covenants under the Royalty-backed Loan and there was no material adverse change in our business, operations or financial condition. We began making principal and interest payments against the Royalty-backed Loan in the first quarter of 2017 and therefore had no capitalized interest in the three and nine months ended September 30, 2018 . In addition, we recorded accrued interest, which is included in accrued expenses, of $0.5 million and $0.7 million as of September 30, 2018 and December 31, 2017 , respectively In connection with the Royalty-backed Loan, we paid the Royalty-backed Lenders a fee of $1.5 million and incurred additional debt issuance costs totaling $0.4 million , which includes expenses that we paid on behalf of the Royalty-backed Lenders and expenses incurred directly by us. Debt issuance costs and the lender fee have been netted against the debt as of September 30, 2018 , and are being amortized over the estimated term of the debt using the effective interest method. For the three months ended September 30, 2018 and 2017, the Company recognized interest expense, including amortization of the debt discount, related to the Royalty-backed Loan of $3.1 million and $4.2 million , respectively, and $10.5 million and $12.4 million for the nine months ended September 30, 2018 and 2017 , respectively. The assumptions used in determining the expected repayment term of the debt and amortization period of the issuance costs requires that we make estimates that could impact the short- and long-term classification of these costs, as well as the period over which these costs will be amortized. The outstanding balance of the Royalty-backed Loan as of September 30, 2018 was $101.0 million , net of unamortized debt discount of $0.4 million . Oxford and SVB Loan and Security Agreement In June 2016 , we entered into a Loan and Security Agreement (the “Loan Agreement”) with Oxford Finance LLC (“Oxford”) and Silicon Valley Bank (“SVB”) (collectively, the “Lenders”), providing a senior secured loan facility of up to an aggregate principal amount of $70.0 million , comprising a $55.0 million draw in June 2016 and an additional $15.0 million tranche, which we had the option to draw during the second quarter of 2017 and did not exercise. The initial proceeds were partially used to pay the outstanding principal and final payment of $4.25 million owed on a previous loan agreement with the Lenders. The remaining proceeds are being used for working capital and general business requirements. The senior secured loan facility carries a fixed interest rate of 8.25% . The repayment schedule provides for interest only payments for the first 18 months , followed by consecutive equal monthly payments of principal and interest in arrears through the maturity date of January 1, 2021 . The Loan Agreement provides for a final payment equal to 5.50% of the initial $55.0 million principal amount. The final payment is due when the Loan Agreement becomes due or upon the prepayment of the facility. We have the option to prepay the outstanding balance of the Loan Agreement in full, subject to a prepayment fee of 2% in the first year and 1% in the second year of the Loan Agreement. In connection with the Loan Agreement, the debt offering costs have been recorded as a debt discount in our condensed consolidated balance sheets which, together with the final payment and fixed interest rate payments, are being amortized and recorded as interest expense throughout the life of the loan using the effective interest rate method. The Loan Agreement is secured by substantially all of the assets of the Company and our subsidiary, Halozyme, Inc., except that the collateral does not include any equity interests in Halozyme, Inc., any of our intellectual property (including all licensing, collaboration and similar agreements relating thereto), and certain other excluded assets. The Loan Agreement contains customary representations, warranties and covenants by us, which covenants limit our ability to convey, sell, lease, transfer, assign or otherwise dispose of certain of our assets; engage in any business other than the businesses currently engaged in by us or reasonably related thereto; liquidate or dissolve; make certain management changes; undergo certain change of control events; create, incur, assume, or be liable with respect to certain indebtedness; grant certain liens; pay dividends and make certain other restricted payments; make certain investments; make payments on any subordinated debt; enter into transactions with any of our affiliates outside of the ordinary course of business or permit our subsidiaries to do the same; and make any voluntary prepayment of or modify certain terms of the Royalty-backed Loan. In addition, subject to certain exceptions, we are required to maintain with SVB our primary deposit accounts, securities accounts and commodities, and to do the same for our subsidiary, Halozyme, Inc. The Loan Agreement also contains customary indemnification obligations and customary events of default, including, among other things, our failure to fulfill certain of our obligations under the Loan Agreement and the occurrence of a material adverse change which is defined as a material adverse change in our business, operations, or condition (financial or otherwise), a material impairment of the prospect of repayment of any portion of the loan, a material impairment in the perfection or priority of the Lender’s lien in the collateral or in the value of such collateral or the occurrence of an event of default under the Royalty-backed Loan. In the event of default by us under the Loan Agreement, the Lenders would be entitled to exercise their remedies thereunder, including the right to accelerate the debt, upon which we may be required to repay all amounts then outstanding under the Loan Agreement, which could harm our financial condition. As of September 30, 2018 , we were in compliance with all covenants under the Loan Agreement and there was no material adverse change in our business, operations or financial condition. Interest expense, including amortization of the debt discount, related to the Loan Agreement totaled $1.2 million and $1.4 million for the three months ended September 30, 2018 and 2017, respectively, and $3.8 million and $4.1 million for the nine months ended September 30, 2018 and 2017 , respectively. Accrued interest, which is included in accrued expenses, was $0.3 million and $0.4 million as of September 30, 2018 and December 31, 2017 , respectively. The outstanding term loan balance was $45.5 million as of September 30, 2018 , inclusive of $2.0 million of accretion of the final payment and net of unamortized debt discount related to offering costs of $0.2 million . |
Share-based Compensation (Notes
Share-based Compensation (Notes) | 9 Months Ended |
Sep. 30, 2018 | |
Share-based Compensation [Abstract] | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | Share-based Compensation Total share-based compensation expense related to share-based awards was comprised of the following (in thousands): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Research and development $ 4,407 $ 3,060 $ 13,107 $ 9,891 Selling, general and administrative 4,460 4,702 13,577 13,377 Share-based compensation expense $ 8,867 $ 7,762 $ 26,684 $ 23,268 Share-based compensation expense by type of share-based award (in thousands): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Stock options $ 4,645 $ 4,973 $ 14,026 $ 14,971 RSAs, RSUs and PRSUs 4,222 2,789 12,658 8,297 $ 8,867 $ 7,762 $ 26,684 $ 23,268 We granted stock options to purchase approximately 0.4 million and 0.1 million shares of common stock during the three months ended September 30, 2018 and 2017 , respectively, and 2.3 million and 2.5 million shares of the Company’s common stock during the nine months ended September 30, 2018 and 2017 , respectively. The exercise price of stock options granted is equal to the closing price of the common stock on the date of grant. The fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton option pricing model (“Black-Scholes model”). Expected volatility is based on historical volatility of our common stock. The expected term of options granted is based on analyses of historical employee termination rates and option exercises. The risk-free interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The dividend yield assumption is based on the expectation of no future dividend payments. The assumptions used in the Black-Scholes model were as follows: Three Months Ended Nine Months Ended 2018 2017 2018 2017 Expected volatility 58.6-60.6% 70.5-70.8% 58.7-70.1% 70.5-71.7% Average expected term (in years) 5.4 5.6 5.5 5.6 Risk-free interest rate 2.75-2.87% 1.73-1.93% 2.25-2.87% 1.73-1.94% Expected dividend yield — — — — Total unrecognized estimated compensation cost by type of award and the weighted-average remaining requisite service period over which such expense is expected to be recognized (in thousands, unless otherwise noted): September 30, 2018 Unrecognized Expense Remaining Weighted-Average Recognition Period (years) Stock options $ 38,966 2.45 RSAs $ 2,743 1.09 RSUs $ 26,434 2.24 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 9 Months Ended |
Sep. 30, 2018 | |
Equity [Abstract] | |
Stockholders' Equity (Deficit) | Stockholders’ Equity In May 2017, we completed an underwritten public offering pursuant to which we sold 11.5 million shares of common stock, including 1.5 million shares sold pursuant to the full exercise of an option to purchase additional shares granted to the underwriters. All of the shares were offered at a public offering price of $12.50 per share, generating $134.9 million in net proceeds, after deducting underwriting discounts and commissions and other offering expenses. We intend to use the net proceeds from this offering to fund continued development of our PEGPH20 oncology program and for other general corporate purposes. During the nine months ended September 30, 2018 and 2017 , we issued an aggregate of 1,280,996 and 1,020,028 shares of common stock, respectively, in connection with the exercises of stock options at a weighted average exercise price of $11.13 and $8.71 per share, respectively, for net proceeds of approximately $14.3 million and $8.9 million , respectively. For the nine months ended September 30, 2018 and 2017 , we issued 438,536 and 375,906 shares of common stock, respectively, upon vesting of certain RSUs for which the RSU holders surrendered 138,986 and 96,069 RSUs, respectively, to pay for minimum withholding taxes totaling approximately $4.2 million and $1.9 million , respectively. In addition, we issued 67,959 and 98,945 shares of common stock in connection with the grants of RSAs during the nine months ended September 30, 2018 and 2017 , respectively. Stock options and unvested restricted units totaling approximately 13.4 million shares and 14.7 million shares of our common stock were outstanding as of September 30, 2018 and December 31, 2017 , respectively. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies From time to time, we may be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of our business. Any of these claims could subject us to costly legal expenses and, while we generally believe that we have adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage or our policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on our consolidated results of operations and financial position. Additionally, any such claims, whether or not successful, could damage our reputation and business. We currently are not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on our consolidated results of operations or financial position. |
Subsequent Event (Notes)
Subsequent Event (Notes) | 9 Months Ended |
Sep. 30, 2018 | |
Subsequent Event [Line Items] | |
Subsequent Events [Text Block] | Subsequent Events In October 2018, we entered into an agreement with Roche for the right to develop and commercialize one additional exclusive target and an option to select two additional targets within four years using our ENHANZE technology for an upfront payment of $25.0 million . We will receive potential milestone payments of up to $160.0 million to $165.0 million per target, subject to the achievement of specific development, regulatory and sales-based milestones. We will also receive mid-single digit royalties on sales of commercialized products. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) related to a quarterly report on Form 10-Q. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for a complete set of financial statements. These interim unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2017 , filed with the SEC on February 20, 2018. The unaudited financial information for the interim periods presented herein reflects all adjustments which, in the opinion of management, are necessary for a fair presentation of the financial condition and results of operations for the periods presented, with such adjustments consisting only of normal recurring adjustments. Certain reclassifications have been made to the prior period condensed consolidated statement of cash flows within operating activities to conform to the current period presentation. There was no change to net cash used in operating activities. Operating results for interim periods are not necessarily indicative of the operating results for an entire fiscal year. The accompanying condensed consolidated financial statements include the accounts of Halozyme Therapeutics, Inc. and our wholly owned subsidiary, Halozyme, Inc., and Halozyme, Inc.’s wholly owned subsidiaries, Halozyme Holdings Ltd., Halozyme Royalty LLC, Halozyme Switzerland GmbH and Halozyme Switzerland Holdings GmbH. All intercompany accounts and transactions have been eliminated. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates. |
Cash Equivalents | Cash Equivalents and Marketable Securities Cash equivalents consist of highly liquid investments, readily convertible to cash, that mature within ninety days or less from the date of purchase. As of September 30, 2018 , our cash equivalents consisted of money market funds and commercial paper. |
Marketable Securities | Marketable securities are investments with original maturities of more than ninety days from the date of purchase that are specifically identified to fund current operations. Marketable securities are considered available-for-sale. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date which reflects management’s intention to use the proceeds from the sale of these investments to fund our operations, as necessary. Such available-for-sale investments are carried at fair value with unrealized gains and losses recorded in other comprehensive gain (loss) and included as a separate component of stockholders’ equity (deficit). The cost of marketable securities is adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion is included in investment and other income, net in the condensed consolidated statements of operations. We use the specific identification method for calculating realized gains and losses on marketable securities sold. Realized gains and losses and declines in value judged to be other-than-temporary on marketable securities, if any, are included in investment and other income, net in the consolidated statements of operations. |
Restricted Cash | Restricted Cash Under the terms of the leases of our facilities, we are required to maintain letters of credit as security deposits during the terms of such leases. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The authoritative guidance for fair value measurements establishes a three tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. Our financial instruments include cash equivalents, available-for-sale marketable securities, accounts receivable, prepaid expenses and other assets, accounts payable, accrued expenses and long-term debt. Fair value estimates of these instruments are made at a specific point in time, based on relevant market information. These estimates may be subjective in nature and involve uncertainties and matters of significant judgment and therefore cannot be determined with precision. The carrying amount of cash equivalents, accounts receivable, prepaid expenses and other assets, accounts payable and accrued expenses are generally considered to be representative of their respective fair values because of the short-term nature of those instruments. Based on Level 3 inputs and the borrowing rates currently available for loans with similar terms, we believe the fair value of long-term debt approximates its carrying value. Available-for-sale marketable securities consist of asset-backed securities, corporate debt securities, U.S. Treasury securities and commercial paper, and are measured at fair value using Level 1 and Level 2 inputs. Level 2 financial instruments are valued using market prices on less active markets and proprietary pricing valuation models with observable inputs, including interest rates, yield curves, maturity dates, issue dates, settlement dates, reported trades, broker-dealer quotes, issue spreads, benchmark securities or other market related data. We obtain the fair value of Level 2 investments from our investment manager, who obtains these fair values from a third-party pricing source. We validate the fair values of Level 2 financial instruments provided by our investment manager by comparing these fair values to a third-party pricing source. |
Inventories | Inventories Inventories are stated at lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Inventories are reviewed periodically for potential excess, dated or obsolete status. We evaluate the carrying value of inventories on a regular basis, taking into account such factors as historical and anticipated future sales compared to quantities on hand, the price we expect to obtain for products in their respective markets compared with historical cost and the remaining shelf life of goods on hand. We capitalize inventory costs associated with our drug candidates prior to receipt of regulatory approval, based on management’s judgment of probable future commercialization. We would be required to expense these capitalized costs upon a change in such judgment, due to, among other factors, a decision denying approval of the drug candidate by regulatory agencies. Bulk rHuPH20 formulations manufactured for partner use prior to our partner receiving marketing approval from the U.S. Food and Drug Administration (“FDA”) or comparable regulatory agencies in foreign countries and with no alternative future use are recorded as research and development expense. All direct manufacturing costs incurred after the partner receives marketing approval are capitalized as inventory. Bulk rHuPH20 formulations manufactured for general partner and internal use, which can potentially be used by any collaboration partner or by us in any stage of development or in commercial product, and ENHANZE drug product used by our partners in clinical trials, is considered to have alternative future use and all manufacturing costs are capitalized as inventory. Inventories used in our clinical trials are expensed at the time the inventories are packaged for the clinical trials. |
Revenue Recognition | Revenue Recognition We generate revenues from payments received under collaborative agreements and product sales. As of January 1, 2018, we adopted ASC 606, Revenue from Contracts with Customers (ASC 606) which affects how we recognize revenues in these arrangements. We applied the provisions of ASC 606 using the modified retrospective approach, with the cumulative effect of the adoption recognized as of January 1, 2018, to all contracts that had not been completed as of that date. Under ASC 606, we recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the promised goods or services in the contract; (ii) identify the performance obligations in the contract, including whether they are distinct in the context of the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligations. Amounts reported in prior periods have not been adjusted. Accordingly, the reported revenue amounts for the three and nine months ended September 30, 2018 and 2017 are based on different accounting policies. Prior to the ASC 606 adoption, revenue was recognized when all of the following criteria were met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the seller’s price to the buyer is fixed or determinable; and (4) collectibility is reasonably assured. Differences between the revenue recognition policies applicable prior to the adoption and ASC 606 are described in the following sections and in Note 4. Revenues under Collaborative Agreements - as reported under ASC 606 beginning January 1, 2018 Under these agreements, we grant the collaboration partner a worldwide license to develop and commercialize products using our ENHANZE technology to combine our patented rHuPH20 enzyme with their proprietary biologics directed at up to a specified number of targets. Targets are usually licensed on an exclusive, global basis. Targets selected subsequent to inception of the arrangement require payment of an additional license fee. The collaboration partner is responsible for all development, manufacturing, clinical, regulatory, sales and marketing costs for any products developed under the agreement. We are responsible for supply of bulk rHuPH20 based on the collaboration partner’s purchase orders, and may also be separately engaged to perform research and development services. We collect an upfront license payment from the collaboration partner, and are also entitled to receive event-based payments subject to the collaboration partner’s achievement of specified development, regulatory and sales-based milestones. In several agreements, collaboration partners pay us annual fees to maintain their exclusive license rights if they are unable to advance product development to specified stages. We earn separate fees for bulk rHuPH20 supplies and research and development services. In addition, the collaboration partner will pay us royalties at an on average mid-single digit percent rate of their sales if products under the collaboration are commercialized. All amounts owed to us are noncancelable after the underlying triggering event occurs, and nonrefundable once paid. Unless terminated earlier in accordance with its terms, the collaboration continues in effect until the later of: (i) expiration of the last to expire of the valid claims of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers a product developed under the collaboration, and (ii) expiration of the last to expire royalty term for a product developed under the collaboration, which is determined separately for each country. In the event such valid claims expire prior to the last to expire royalty term, the royalty rate is reduced for the remaining royalty term following such expiration. The collaboration partner may terminate the agreement prior to expiration for any reason in its entirety or on a target-by-target basis generally upon 90 days prior written notice to us. Upon any such termination, the license granted to the collaboration partner (in total or with respect to the terminated target, as applicable) will terminate provided, however, that in the event of expiration of the agreement, the licenses granted will become perpetual, non-exclusive and fully paid. Although these agreements are in form structured as collaborative agreements, we concluded for accounting purposes they represent contracts with customers, and are not subject to accounting literature on collaborative arrangements. This is because we grant to collaboration partners licenses to our intellectual property, and provide supply of bulk rHuPH20 and research and development services which are all outputs of our ongoing activities, in exchange for consideration. We do not develop assets jointly with collaboration partners, and do not share in significant risks of their development or commercialization activities. Accordingly, we concluded our collaborative agreements must be accounted for pursuant to ASC Topic 606, Revenue from Contracts with Customers. Under all of our collaborative agreements, we have identified licenses to use functional intellectual property as the only performance obligation. The intellectual property underlying the license is our proprietary ENHANZE ® technology which represents application of rHuPH20 to facilitate delivery of drugs or fluids. The license grants the collaboration partners right to use our intellectual property as it exists on the effective date of the license, because there is no ongoing development of the ENHANZE technology required. Therefore, we recognize revenue from licenses at the point when the license becomes effective and the collaboration partner has received access to our intellectual property, usually at the inception of the agreement. When collaboration partners can select additional targets to add to the licenses granted, we consider these rights to be options. We evaluate whether such options contain material rights, i.e. have exercise prices that are discounted compared to what we would charge for a similar license to a new collaboration partner. The exercise price of these options includes a combination of the target selection fees, event-based milestone payments and royalties. When these amounts in aggregate are not offered at a discount that exceeds discounts available to other customers, we conclude the option does not contain a material right, and we consider grants of additional licensing rights upon option exercises to be separate contracts (target selection contracts). We provide standard indemnification and protection of licensed intellectual property for our customers. These provisions are part of assurance that the licenses meet the agreements representations and are not obligations to provide goods or services. We also fulfill purchase orders for supply of bulk rHuPH20 and perform research and development services pursuant to projects authorization forms for our collaboration partners, which represent separate contracts. Additionally, we price our supply of bulk rHuPH20 and research and development services at our regular selling prices, called standalone selling price or SSP. Therefore, our collaboration partners do not have material rights to order these items at prices not reflective of SSP. Refer to the discussion below regarding recognition of revenue for these separate contracts. Transaction price for a contract represents the amount to which we are entitled in exchange for providing goods and services to the customer. Transaction price does not include amounts subject to uncertainties unless it is probable that there will be no significant reversal of revenue when the uncertainty is resolved. Apart from the upfront license payment (or target selection fees in the target selection contracts), all other fees we may earn under our collaborative agreements are subject to significant uncertainties of product development. Achievement of many of the event-based development and regulatory milestones may not be probable until such milestones are actually achieved. This generally relates to milestones such as obtaining marketing authorization approvals and successful completion of clinical trials. With respect to other development milestones, e.g. dosing of a first patient in a clinical trial, achievement could be considered probable prior to its actual occurrence, based on the progress towards commencement of the trial. We do not include any amounts subject to uncertainties into the transaction price until it is probable that the amount will not result in a significant reversal of revenue in the future. At the end of each reporting period, we re-evaluate the probability of achievement of such milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. When target exchange rights are held by collaboration partners, and the amounts attributed to these rights are not refundable, they are included in the transaction price. However, they are recorded as deferred revenues because we have a potential performance obligation to provide a new target if the exchange right is exercised. These amounts are recognized in revenue when the right of exchange expires or is exercised. Because our agreements only have one type of performance obligation (licenses) which are typically all transferred at the same time at agreement inception, allocation of transaction price often is not required. However, allocation is required when licenses for some of the individual targets are subject to rights of exchange, because revenue associated with these targets cannot be recognized. We perform an allocation of the upfront amount based on relative SSP of licenses for individual targets. We determine license SSP using income-based valuation approach utilizing risk-adjusted discounted cash flow projections of the estimated return a licensor would receive. When amounts subject to uncertainties, such as milestones and royalties, are included in the transaction price, we attribute them to the specific individual target licenses which generate such milestone or royalty amounts. We also estimate SSP of bulk rHuPH20 and research and development services, to determine that our collaboration partners do not have material rights to order them at discounted prices. For supplies of bulk rHuPH20, because we effectively act as a contract manufacturer to our collaboration partners, we estimate and charge SSP based on the typical contract manufacturer margins consistently with all of our collaborative partners. We determine SSP of research and development services based on a fully-burdened labor rate. Our rates are comparable to those we observe in other collaborative agreements. We also have a history of charging similar rates to all of our collaboration partners. Upfront amounts allocated to licenses to individual targets are recognized as revenue when the license is transferred to the collaboration partner, as discussed above, if the license is not subject to exchange rights, or when the exchange right expires or is exercised. Development milestones and other fees are recognized in revenue when they are included in the transaction price, because by that time we have already transferred the related license to the collaboration partner. Sales-based milestones and royalties cannot be recognized until the underlying sales occur. We do not receive final royalty reports from our collaboration partners until after we complete our financial statements for a prior quarter. Therefore, we recognize revenue based on estimates of the royalty earned, which are based on preliminary reports provided by our collaboration partners. We will record a true-up in the following quarter if necessary, when final royalty reports are received. To date, we have not recorded any material true-ups. In contracts to provide research and development services, such services represent the only performance obligation. The fees are charged based on hours worked by our employees and the fixed contractual rate per hour, plus third-party pass-through costs, on a monthly basis. We recognize revenues as the related services are performed based on the amounts billed, as the collaboration partner consumes the benefit of research and development work simultaneously as we perform these services, and the amounts billed reflect the value of these services to the customer. Refer to Note 4 Revenue , for further discussion on our collaborative arrangements. Prior to the adoption of ASC 606 on January 1, 2018, we recognized upfront amounts received under two of our collaborative agreements straight-line over the contract term in accordance with the accounting standards that were in effect in 2006-2007, when these collaborative agreements were entered into. In addition, we recognized royalty revenue in the period when we received final royalty reports from the collaboration partners, in the quarter following the quarter in which the corresponding sales occurred. There were no other differences in revenue to be recognized under the previously existing authoritative accounting literature and ASC 606 applied to our collaborative agreements. Product Sales, Net - as reported under ASC 606 beginning January 1, 2018 Hylenex Recombinant We sell Hylenex recombinant in the U.S. to wholesale pharmaceutical distributors, who sell the product to hospitals and other end-user customers. Sales to wholesalers are made pursuant to purchase orders subject to the terms of a master agreement, and delivery of individual packages of Hylenex recombinant represent performance obligations under each purchase order. We use a contract manufacturer to produce Hylenex recombinant and a third-party logistics (3PL) vendor to process and fulfill orders . We concluded we are the principal in the sales to wholesalers because we control access to services rendered by both vendors and direct their activities. We have no significant obligations to wholesalers to generate pull-through sales. Selling prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks when wholesalers sell Hylenex recombinant at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”) and government programs. We also pay quarterly distribution fees to certain wholesalers for inventory reporting and chargeback processing, and to GPOs for access to GPO members. We concluded the benefits received in exchange for these fees are not distinct from our sales of Hylenex recombinant, and accordingly we apply these amounts to reduce revenues. Wholesalers also have rights to return unsold product nearing or past the expiration date. Because of the shelf life of Hylenex recombinant and our lengthy return period, there may be a significant period of time between when the product is shipped and when we issue credits on returned product. We estimate the transaction price when we receive each purchase order taking into account the expected reductions of the selling price initially billed to the wholesaler arising from all of the above factors. We have compiled historical experience and data to estimate future returns and chargebacks of Hylenex recombinant and the impact of the other discounts and fees we pay. When estimating these adjustments to the transaction price, we reduce it sufficiently to be able to assert that it is probable that there will be no significant reversal of revenue when the ultimate adjustment amounts are known. Each purchase order contains only one type of product, and is usually shipped to the wholesaler in a single shipment. Therefore, allocation of the transaction price to individual packages is not required. We recognize revenue from Hylenex recombinant product sales and related cost of sales upon product delivery to the wholesaler location. At that time, the wholesalers take control of the product as they take title, bear the risk of loss of ownership, and have an enforceable obligation to pay us. They also have the ability to direct sales of product to their customers on terms and at prices they negotiate. Although wholesalers have product return rights, we do not believe they have a significant incentive to return the product to us. Upon recognition of revenue from product sales of Hylenex recombinant, the estimated amounts of credit for product returns, chargebacks, distribution fees, prompt payment discounts, and GPO fees are included in sales reserves, accrued liabilities and net of accounts receivable. We monitor actual product returns, chargebacks, discounts and fees subsequent to the sale. If these amounts differ from our estimates, we make adjustments to these allowances, which are applied to increase or reduce product sales revenue and earnings in the period of adjustments. In connection with the orders placed by wholesalers, we incur costs such as commissions to our sales representatives. However, as revenue from product sales is recognized upon delivery to the wholesaler, which occurs shortly after we receive a purchase order, we do not capitalize these commissions and other costs, based on application of a practical expedient allowed in ASC 606. Bulk rHuPH20 We sell bulk rHuPH20 to collaboration partners for use in research and development; subsequent to receiving marketing approval, we sell it for use in collaboration commercial products. Sales are made pursuant to purchase orders subject to the terms of the collaborative agreement, and delivery of units of bulk rHuPH20 represent performance obligations under each purchase order. We provide a standard warranty that the product conforms to specifications. We use a contract manufacturer to produce bulk rHuPH20 and have concluded we are the principal in the sales to collaboration partners. The transaction price for each purchase order of bulk rHuPH20 is fixed based on the cost of production plus a contractual markup, and is not subject to adjustments. Allocation of the transaction price to individual quantities of the product is usually not required because each order contains only one type of product. We recognize revenue from bulk rHuPH20 formulations as product sales and related cost of sales upon transfer of title to our partners. At that time, the partners take control of the product, bear the risk of loss of ownership, and have an enforceable obligation to pay us. There were no differences in how the previously existing authoritative accounting literature applied to our product sales transactions. ENHANZE Drug Product We sell ENHANZE drug product to collaboration partners for use in research and development in early phase clinical studies. Sales are made pursuant to purchase orders subject to the terms of the collaborative agreement, and delivery of units of ENHANZE drug product represent performance obligations under each purchase order. We provide a standard warranty that the product conforms to specifications. We use a contract manufacturer to produce ENHANZE drug product and we concluded we are the principal in the sales to collaboration partners. The transaction price for each purchase order of ENHANZE drug product is fixed based on the cost of production plus a contractual markup, and is not subject to adjustments. Allocation of the transaction price to individual quantities of the product is usually not required because each order contains only one type of product. We recognize revenue from ENHANZE drug product as product sales and related cost of sales upon transfer of title to our partners. At that time, the partners take control of the product, bear the risk of loss of ownership, and have an enforceable obligation to pay us. There were no differences in how the previously existing authoritative accounting literature applied to our product sales transactions. Revenue Presentation In our statements of operations, we report as revenues under collaborative agreements the upfront payments, event-based development and regulatory milestones and sales milestones. We also include in this category revenues from separate research and development contracts pursuant to project authorization forms and sales of bulk rHuPH20 that has no alternative future use. We report royalties received from collaboration partners as a separate line in our statements of operations. Revenues from sales of Hylenex recombinant, bulk rHuPH20 that has alternative future use and ENHANZE drug product are included in product sales, net. In footnotes to our financial statements, we provide disaggregated revenue information by type of arrangement (product sales, net, collaborative agreements and research and development services), and additionally, by type of payment stream received under collaborative agreements (upfront amounts, event-based development and regulatory milestones and other fees, sales milestones and royalties). |
Cost of Product Sales | Cost of Product Sales Cost of product sales consists primarily of raw materials, third-party manufacturing costs, fill and finish costs, freight costs, internal costs and manufacturing overhead associated with the production of Hylenex recombinant and bulk rHuPH20 and ENHANZE drug product that has alternative future use. Cost of product sales also consists of the write-down of excess, dated and obsolete inventories and the write-off of inventories that do not meet certain product specifications, if any. |
Research and Development Expenses | Research and Development Expenses Research and development expenses include salaries and benefits, facilities and other overhead expenses, external clinical trial expenses, research related manufacturing services, contract services and other outside expenses. Research and development expenses are charged to operating expenses as incurred when these expenditures relate to our research and development efforts and have no alternative future uses. When bulk rHuPH20 is manufactured for use in research and development by us or our partners and the product cannot be redirected for alternative use due to formulation and manufacturing specifications, the manufacturing costs are recorded as research and development expense. Bulk rHuPH20 that is manufactured for partner use prior to our partner receiving marketing approval from the FDA or comparable regulatory agencies in foreign countries and meet these specifications is recorded as research and development expenses. The manufacturing costs of bulk rHuPH20 for the approved collaboration products, Herceptin SC, MabThera SC (RITUXAN HYCELA™ in the U.S.) and HYQVIA, incurred after the receipt of marketing approvals are capitalized as inventory. Bulk rHuPH20 formulations manufactured for general partner and internal use, which can potentially be used by any collaboration partner or by us in any stage of development or in commercial products, is considered to have alternative future use and all manufacturing costs are capitalized as inventory. Inventories used in our clinical trials are expensed at the time the inventories are packaged for the clinical trials. We are obligated to make upfront payments upon execution of certain research and development agreements. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred. Such amounts are recognized as expense as the related goods are delivered or the related services are performed or such time when we do not expect the goods to be delivered or services to be performed. Milestone payments that we make in connection with in-licensed technology for a particular research and development project that have no alternative future uses (in other research and development projects or otherwise) and therefore no separate economic value are expensed as research and development costs at the time the costs are incurred. |
Clinical Trial Expenses | Clinical Trial Expenses We make payments in connection with our clinical trials under contracts with contract research organizations that support conducting and managing clinical trials. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Generally, these agreements set forth the scope of work to be performed at a fixed fee, unit price or on a time and materials basis. A portion of our obligation to make payments under these contracts depends on factors such as the successful enrollment or treatment of patients or the completion of other clinical trial milestones. Expenses related to clinical trials are accrued based on our estimates and/or representations from service providers regarding work performed, including actual level of patient enrollment, completion of patient studies and progress of the clinical trials. Other incidental costs related to patient enrollment or treatment are accrued when reasonably certain. If the amounts we are obligated to pay under our clinical trial agreements are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), we adjust our accruals accordingly on a prospective basis. Revisions to our contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain. |
Share-Based Compensation | Share-Based Compensation We record compensation expense associated with stock options, restricted stock awards (“RSAs”), restricted stock units (“RSUs”), and RSUs with performance conditions (“PRSUs”) in accordance with the authoritative guidance for stock-based compensation. The cost of employee services received in exchange for an award of an equity instrument is measured at the grant date, based on the estimated fair value of the award, and is recognized as expense on a straight-line basis over the requisite service period of the award. Share-based compensation expense for an award with a performance condition is recognized when the achievement of such performance condition is determined to be probable. If the outcome of such performance condition is not determined to be probable or is not met, no compensation expense is recognized and any previously recognized compensation expense is reversed. Forfeitures are recognized as a reduction of share-based compensation expense as they occur. |
Income Taxes | Income Taxes We provide for income taxes using the liability method. Under this method, deferred income tax assets and liabilities are determined based on the differences between the financial statement carrying amounts of existing assets and liabilities at each year end and their respective tax bases and are measured using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Significant judgment is required by management to determine our provision for income taxes, our deferred tax assets and liabilities, and the valuation allowance to record against our net deferred tax assets, which are based on complex and evolving tax regulations throughout the world. Deferred tax assets and other tax benefits are recorded when it is more likely than not that the position will be sustained upon audit. While we have begun to utilize certain of our net operating losses, we have not yet established a track record of profitability. Accordingly, valuation allowances have been recorded to reduce our net deferred tax assets to zero , with the exception of the alternative minimum tax ("AMT") credit carryover of $5.5 million . Under the Tax Cuts and Jobs Act (the “Act”) enacted in December 2017, the AMT credit carryover will either be utilized, or if unutilized fully refunded in 2022. For all other deferred tax assets the valuation allowance will reduce the net value to zero until such time as we can demonstrate an ability to realize them. |
Net Loss Per Share | Net (Loss) Income Per Share Basic net (loss) income per common share is computed by dividing net (loss) income for the period by the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents. Outstanding stock options, unvested RSAs, unvested RSUs and unvested PRSUs are considered common stock equivalents and are only included in the calculation of diluted earnings per common share when net income is reported and their effect is dilutive. |
Segment Information | Segment Information We operate our business in one segment, which includes all activities related to the research, development and commercialization of our proprietary enzymes. This segment also includes revenues and expenses related to (i) research and development and bulk rHuPH20 manufacturing activities conducted under our collaborative agreements with third parties and (ii) product sales of Hylenex recombinant. The chief operating decision-maker reviews the operating results on an aggregate basis and manages the operations as a single operating segment. |
Adoption and Pending Adoption of Recent Accounting Pronouncements | Adoption and Pending Adoption of Recent Accounting Pronouncements The following table provides a brief description of recently issued accounting standards, those adopted in the current period and those not yet adopted: Standard Description Effective Date Effect on the Financial Statements or Other Significant Matters In January 2016, the FASB issued ASU 2016-01, Financial Instruments - Overall; Recognition and Measurement of Financial Assets and Financial Liabilities. The new guidance supersedes the guidance to classify equity securities with readily determinable fair values into different categories (that is, trading or available-for-sale) and requires equity securities to be measured at fair value with changes in the fair value recognized through net income. The new guidance requires public business entities that are required to disclose fair value of financial instruments measured at amortized cost on the balance sheet to measure that fair value using the exit price notion consistent with Topic 820, Fair Value Measurement. January 1, 2018 We currently do not hold equity securities. The adoption did not have a material impact on our condensed consolidated financial position or results of operations. In October 2016, the FASB issued ASU 2016-16, Income Taxes; Intra-Entity Transfers of Assets Other Than Inventory. The new guidance removes the current requirement to defer the income tax effects of intercompany transfers of assets other than inventory (e.g., intangible assets) until the asset has been sold to an outside party. As a result, the income tax consequences of an intercompany transfer of assets other than inventory will be recognized in the current period income statement rather than being deferred until the assets leave the consolidated entity. January 1, 2018 We adopted the new guidance on January 1, 2018. The adoption did not have a material impact on our condensed consolidated financial position or results of operations. Standard Description Effective Date Effect on the Financial Statements or Other Significant Matters In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). In March, April, May and December 2016, the FASB issued additional guidance related to Topic 606. The new standard superseded nearly all existing revenue recognition guidance. Under Topic 606, an entity is required to recognize revenue upon transfer of promised goods or services to customers in an amount that reflects the expected consideration to be received in exchange for those goods or services. Topic 606 defines a five-step process in order to achieve this core principle, which may require the use of judgment and estimates, and also requires expanded qualitative and quantitative disclosures relating to the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers, including significant judgments and estimates used. The new standard also defines accounting for certain costs related to origination and fulfillment of contracts with customers, including whether such costs should be capitalized. January 1, 2018 We adopted the new guidance on January 1, 2018 using the modified retrospective approach. Refer to Notes 2 “Revenue Recognition” and 4 for additional detail regarding the impact of this adoption. Standard Description Effective Date Effect on the Financial Statements or Other Significant Matters In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). In July 2018, the FASB issued additional guidance related to Topic 842. The new guidance requires lessees to recognize assets and liabilities for most leases and provides enhanced disclosures. January 1, 2019. Early adoption is permitted. We plan to implement the guidance on January 1, 2019 using a modified retrospective transition basis for leases existing as of the period of adoption. In order to adopt the new standard, we will be using available practical expedients and newly implemented processes and internal controls for lease accounting. The practical expedients allow us to carry forward our historical assessment of whether existing agreements are or contain a lease and the classification of our existing lease arrangements. We expect all of our real-estate and automobile operating lease commitments will be recognized as lease liabilities with corresponding right-of-use assets upon adoption, resulting in an increase in the assets and liabilities of the consolidated balance sheet. We anticipate that the adoption will have a material impact on our consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820). The new guidance removes, modifies and adds to certain disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement. January 1, 2020 We plan to adopt the new guidance on January 1, 2020. We do not anticipate the adoption will have a material impact on our condensed consolidated financial position or results of operations. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | A reconciliation of the numerators and the denominators of the basic and diluted net (loss) income per common share computations is as follows (in thousands, except per share amounts): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Numerator: Net (loss) income $ (27,850 ) $ 2,749 $ (78,204 ) $ (60,911 ) Denominator: Weighted average common shares outstanding for basic 143,949 141,190 143,396 134,633 Net effect of dilutive common stock equivalents — 2,046 — — Weighted average common shares outstanding for diluted 143,949 143,236 143,396 134,633 Net (loss) income per share: Basic $ (0.19 ) $ 0.02 $ (0.55 ) $ (0.45 ) Diluted $ (0.19 ) $ 0.02 $ (0.55 ) $ (0.45 ) |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Available-for-sale marketable securities | Available-for-sale marketable securities consisted of the following (in thousands): September 30, 2018 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Asset-backed securities $ 39,721 $ — $ (24 ) $ 39,697 Corporate debt securities 74,699 — (181 ) 74,518 U.S. Treasury securities 99,716 — (248 ) 99,468 Commercial paper 95,664 — — 95,664 $ 309,800 $ — $ (453 ) $ 309,347 December 31, 2017 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate debt securities $ 117,427 $ — $ (235 ) $ 117,192 U.S. Treasury securities 66,601 — (201 ) 66,400 Commercial paper 116,882 — — 116,882 $ 300,910 $ — $ (436 ) $ 300,474 |
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | The following table summarizes, by major security type, our cash equivalents and available-for-sale marketable securities that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands): September 30, 2018 December 31, 2017 Level 1 Level 2 Total estimated fair value Level 1 Level 2 Total estimated fair value Cash equivalents: Money market funds $ 55,271 $ — $ 55,271 $ 142,091 $ — $ 142,091 Commercial paper — — — — 15,700 15,700 Available-for-sale marketable securities: Asset-backed securities — 39,697 39,697 — — — Corporate debt securities — 74,518 74,518 — 117,192 117,192 U.S. Treasury securities 99,468 — 99,468 66,400 — 66,400 Commercial paper — 95,664 95,664 — 116,882 116,882 $ 154,739 $ 209,879 $ 364,618 $ 208,491 $ 249,774 $ 458,265 |
Revenue Collaborative Agreement
Revenue Collaborative Agreements (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Disaggregation of Revenue [Table Text Block] | Our disaggregated revenues were as follows (in thousands): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Royalties $ 18,710 $ 17,119 $ 59,643 $ 45,839 Product sales, net Sales of bulk rHuPH20 $ 2,402 $ 9,748 $ 6,350 $ 26,825 Sales of ENHANZE drug product 186 — 322 — Sales of Hylenex 3,681 3,841 10,881 10,978 Total product sales, net 6,269 13,589 17,553 37,803 Revenues under collaborative agreements: Upfront license fees — 30,352 1,336 31,054 Event-based development milestones and other fees — 329 11,000 988 Sales-based milestones — 342 — 1,028 Research and development services 577 2,000 2,098 10,337 Total revenues under collaborative agreements 577 33,023 14,434 43,407 Total revenue $ 25,556 $ 63,731 $ 91,630 $ 127,049 |
Contract with Customer, Asset and Liability [Table Text Block] | Accounts receivable, net, other contract assets and deferred revenues (contract liabilities) from contracts with customers, including collaboration partners, consisted of the following (in thousands): September 30, 2018 December 31, 2017 Accounts receivable, net $ 22,656 $ 22,133 Other contract assets 5,000 — Deferred revenues 9,754 60,865 |
Other collaborators [Member] | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |
Revenue Recognition, Multiple-deliverable Arrangements [Table Text Block] | contract assets of $5.0 million related to collaborative agreements as of September 30, 2018 , for amounts considered probable to receive for development milestones that relate to intellectual property licenses granted to collaboration partners in prior periods. The following table presents amounts under our collaborative agreements included in the transaction price (i.e. cumulative amounts triggered or probable) as of September 30, 2018 (in thousands): Upfront (1) Development (2) Sales (3) Royalty Total Collaboration partner and agreement date: Roche (December 2006 and September 2017) $ 70,000 $ 25,000 $ 22,000 $ 211,613 $ 328,613 Baxalta (September 2007) 10,000 3,000 9,000 22,438 44,438 Pfizer (December 2012) 14,500 2,000 — — 16,500 Janssen (December 2014) 15,250 15,000 — — 30,250 AbbVie (June 2015) 23,000 6,000 — — 29,000 Lilly (December 2015) 33,000 — — — 33,000 BMS (September 2017) 105,000 5,000 — — 110,000 Alexion (December 2017) 40,000 5,000 — — 45,000 |
Revenue Disaggregated Revenue (
Revenue Disaggregated Revenue (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregation of Revenue [Table Text Block] | Our disaggregated revenues were as follows (in thousands): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Royalties $ 18,710 $ 17,119 $ 59,643 $ 45,839 Product sales, net Sales of bulk rHuPH20 $ 2,402 $ 9,748 $ 6,350 $ 26,825 Sales of ENHANZE drug product 186 — 322 — Sales of Hylenex 3,681 3,841 10,881 10,978 Total product sales, net 6,269 13,589 17,553 37,803 Revenues under collaborative agreements: Upfront license fees — 30,352 1,336 31,054 Event-based development milestones and other fees — 329 11,000 988 Sales-based milestones — 342 — 1,028 Research and development services 577 2,000 2,098 10,337 Total revenues under collaborative agreements 577 33,023 14,434 43,407 Total revenue $ 25,556 $ 63,731 $ 91,630 $ 127,049 |
Certain Balance Sheet Items (Ta
Certain Balance Sheet Items (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Balance Sheet Related Disclosures [Abstract] | |
Summary of Accounts Receivable | Accounts receivable, net and other contract assets consisted of the following (in thousands): September 30, December 31, Accounts receivable from product sales to collaborators $ 1,980 $ 18,475 Accounts receivable from revenues under collaborative agreements 451 2,142 Accounts receivable from royalty payments 18,777 — Accounts receivable from other product sales 1,949 2,075 Other contract assets 5,000 — Subtotal 28,157 22,692 Allowance for distribution fees and discounts (501 ) (559 ) Total accounts receivable, net and other contract assets $ 27,656 $ 22,133 |
Summary of Inventories | Inventories consisted of the following (in thousands): September 30, December 31, Raw materials $ 625 $ 377 Work-in-process 15,401 2,131 Finished goods 2,259 2,638 Total inventories $ 18,285 $ 5,146 |
Summary of Prepaid Expenses and Other Assets | Prepaid expenses and other assets consisted of the following (in thousands): September 30, December 31, Prepaid manufacturing expenses $ 8,844 $ 2,337 Prepaid research and development expenses 9,195 7,793 Other prepaid expenses 2,344 2,585 Other assets 6,527 6,717 Total prepaid expenses and other assets 26,910 19,432 Less long-term portion 7,291 5,553 Total prepaid expenses and other assets, current $ 19,619 $ 13,879 |
Summary of Property and Equipment | Property and equipment, net consisted of the following (in thousands): September 30, December 31, Research equipment $ 9,528 $ 9,268 Manufacturing equipment 3,979 1,702 Computer and office equipment 4,811 3,725 Leasehold improvements 4,160 2,715 Subtotal 22,478 17,410 Accumulated depreciation and amortization (15,688 ) (13,890 ) Property and equipment, net $ 6,790 $ 3,520 |
Summary of Accrued Expenses | Accrued expenses consisted of the following (in thousands): September 30, December 31, Accrued outsourced research and development expenses $ 19,786 $ 18,757 Accrued compensation and payroll taxes 12,914 13,384 Accrued outsourced manufacturing expenses 4,743 2,504 Other accrued expenses 6,142 5,396 Total accrued expenses 43,585 40,041 Less long-term portion 565 440 Total accrued expenses, current $ 43,020 $ 39,601 |
Summary of Deferred Revenue | Deferred revenue consisted of the following (in thousands): September 30, December 31, Collaborative agreements License fees and event-based payments: Roche $ — $ 39,379 Other 2,265 15,999 Total license fees and event-based payments 2,265 55,378 Product sales 7,489 5,487 Total deferred revenue 9,754 60,865 Less current portion 4,247 6,568 Deferred revenue, net of current portion $ 5,507 $ 54,297 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Share-based Compensation [Abstract] | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | Total share-based compensation expense related to share-based awards was comprised of the following (in thousands): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Research and development $ 4,407 $ 3,060 $ 13,107 $ 9,891 Selling, general and administrative 4,460 4,702 13,577 13,377 Share-based compensation expense $ 8,867 $ 7,762 $ 26,684 $ 23,268 |
Schedule of Compensation Cost for Share-based Payment Arrangements, Allocation of Share-based Compensation Costs by Plan [Table Text Block] | Share-based compensation expense by type of share-based award (in thousands): Three Months Ended Nine Months Ended 2018 2017 2018 2017 Stock options $ 4,645 $ 4,973 $ 14,026 $ 14,971 RSAs, RSUs and PRSUs 4,222 2,789 12,658 8,297 $ 8,867 $ 7,762 $ 26,684 $ 23,268 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | The assumptions used in the Black-Scholes model were as follows: Three Months Ended Nine Months Ended 2018 2017 2018 2017 Expected volatility 58.6-60.6% 70.5-70.8% 58.7-70.1% 70.5-71.7% Average expected term (in years) 5.4 5.6 5.5 5.6 Risk-free interest rate 2.75-2.87% 1.73-1.93% 2.25-2.87% 1.73-1.94% Expected dividend yield — — — — |
Schedule of Unrecognized Compensation Cost, Nonvested Awards [Table Text Block] | Total unrecognized estimated compensation cost by type of award and the weighted-average remaining requisite service period over which such expense is expected to be recognized (in thousands, unless otherwise noted): September 30, 2018 Unrecognized Expense Remaining Weighted-Average Recognition Period (years) Stock options $ 38,966 2.45 RSAs $ 2,743 1.09 RSUs $ 26,434 2.24 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Restricted Cash and Investments, Current [Abstract] | ||
Restricted cash | $ 500 | $ 500 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies Inventories (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2018 | Dec. 31, 2017 | |
Inventory [Line Items] | |||
Product sales expensed as R&D | $ 1,700 | $ 2,300 | |
Inventory, Net | 18,285 | 18,285 | $ 5,146 |
Hylenex Recombinant [Member] | |||
Inventory [Line Items] | |||
Inventory, Net | 2,400 | 2,400 | 2,900 |
bulk rHuPH20 | |||
Inventory [Line Items] | |||
Inventory, Net | 15,900 | 15,900 | $ 2,200 |
Costs expensed to R&D [Domain] | |||
Inventory [Line Items] | |||
Inventory, Net | $ 2,000 | $ 2,000 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies Research and development (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Research and Development Expense | $ 35,540,000 | $ 33,993,000 | $ 113,602,000 | $ 109,267,000 |
In-license technologies [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Research and Development Expense | $ 0 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies Income tax (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | ||||
Deferred Tax Assets, Net | $ 0 | $ 0 | ||
Deferred Tax Assets, Tax Credit Carryforwards | 5,500,000 | 5,500,000 | ||
Income tax expense | $ 0 | $ 580,000 | $ 220,000 | $ 970,000 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies Net Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Loss Per Share Disclosure [Line Items] | ||||
Net income (loss) | $ (27,850) | $ 2,749 | $ (78,204) | $ (60,911) |
Weighted Average Number of Shares Outstanding, Basic | 143,949 | 141,190 | 143,396 | 134,633 |
Shares excluded from calculation of diluted net loss, amount | 0 | 2,046 | 0 | 0 |
Weighted Average Number of Shares Outstanding, Diluted | 143,949 | 143,236 | 143,396 | 134,633 |
Earnings Per Share, Basic | $ (0.19) | $ 0.02 | $ (0.55) | $ (0.45) |
Earnings Per Share, Diluted | $ (0.19) | $ 0.02 | $ (0.55) | $ (0.45) |
Net loss per share (Textuals) [Abstract] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 13,800 | 7,800 | 13,800 | 14,300 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies Segment information (Details) | 9 Months Ended |
Sep. 30, 2018Segment | |
Segment Reporting [Abstract] | |
Number of Operating Segments | 1 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies Adoption of Recent Accounting Pronouncements (Details) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | ||
Reclassification of restricted cash | $ 0.5 | $ 0.5 |
Fair Value Measurement (Details
Fair Value Measurement (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Schedule of Available-for-sale Securities | ||
Amortized cost | $ 309,800 | $ 300,910 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (453) | (436) |
Estimated fair value | 309,347 | 300,474 |
Asset-backed Securities [Member] | ||
Schedule of Available-for-sale Securities | ||
Amortized cost | 39,721 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (24) | |
Estimated fair value | 39,697 | |
Corporate Debt Securities [Member] | ||
Schedule of Available-for-sale Securities | ||
Amortized cost | 74,699 | 117,427 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (181) | (235) |
Estimated fair value | 74,518 | 117,192 |
US Treasury Securities [Member] | ||
Schedule of Available-for-sale Securities | ||
Amortized cost | 99,716 | 66,601 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (248) | (201) |
Estimated fair value | 99,468 | 66,400 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities | ||
Amortized cost | 95,664 | 116,882 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated fair value | $ 95,664 | $ 116,882 |
Fair Value Measurement Textuals
Fair Value Measurement Textuals (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Fair Value Disclosures [Abstract] | |
Number of available-for-sale securities in unrealized loss position, less than one year | 27 |
Other than Temporary Impairment Losses, Marketable Securities | $ 0 |
Fair Value Measurement Fair Val
Fair Value Measurement Fair Value Measures (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets, Fair Value Disclosure | $ 364,618 | $ 458,265 |
Available-for-sale Securities | 309,347 | 300,474 |
Fair Value, Assets, Level 1 to Level 2 Transfers, Amount | 0 | 0 |
Money Market Funds [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash and Cash Equivalents, Fair Value Disclosure | 55,271 | 142,091 |
US Treasury Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale Securities | 99,468 | 66,400 |
Commercial Paper [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash and Cash Equivalents, Fair Value Disclosure | 0 | 15,700 |
Available-for-sale Securities | 95,664 | 116,882 |
Corporate Debt Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale Securities | 74,518 | 117,192 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets, Fair Value Disclosure | 154,739 | 208,491 |
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash and Cash Equivalents, Fair Value Disclosure | 55,271 | 142,091 |
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale Securities | 99,468 | 66,400 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets, Fair Value Disclosure | 209,879 | 249,774 |
Fair Value, Inputs, Level 2 [Member] | Commercial Paper [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash and Cash Equivalents, Fair Value Disclosure | 0 | 15,700 |
Available-for-sale Securities | 95,664 | 116,882 |
Fair Value, Inputs, Level 2 [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale Securities | 74,518 | 117,192 |
Fair Value, Inputs, Level 2 [Member] | Asset-backed Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale Securities | 39,697 | |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Investments, Fair Value Disclosure | 0 | $ 0 |
Asset-backed Securities [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Available-for-sale Securities | $ 39,697 |
Fair Value Measurement Maturiti
Fair Value Measurement Maturities (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value Disclosures [Abstract] | ||
Available-for-sale Securities | $ 309,347 | $ 300,474 |
Revenue Collaborative Agreeme_2
Revenue Collaborative Agreements Textuals (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2018 | Dec. 31, 2017 | |
Deferred Revenue (Textual) [Abstract] | |||
Deferred Revenue | $ 9,754 | $ 9,754 | $ 60,865 |
Collaborative Agreements (Textual) | |||
Deferred Revenue, Revenue Recognized | 500 | 2,300 | |
Additional Maximum Proceeds Receivable from Collaborator of License and Collaborative Agreement Upon Achievement of Clinical Development Milestones | 165,000 | 165,000 | |
Roche [Member] | |||
Deferred Revenue (Textual) [Abstract] | |||
Deferred Revenue | $ 0 | 0 | $ 39,379 |
2017 Roche [Member] | |||
Deferred Revenue (Textual) [Abstract] | |||
Nonrefundable Upfront License Fee Payment Received Under Collaborative Agreement | 1,000 | ||
Alexion [Member] | |||
Deferred Revenue (Textual) [Abstract] | |||
Nonrefundable Upfront License Fee Payment Received Under Collaborative Agreement | 5,000 | ||
Development Fees [Member] | Alexion [Member] | |||
Deferred Revenue (Textual) [Abstract] | |||
Nonrefundable Upfront License Fee Payment Received Under Collaborative Agreement | $ 5,000 |
Revenue Collaborative Agreeme_3
Revenue Collaborative Agreements tables (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Deferred Revenue | $ 9,754 | $ 9,754 | $ 60,865 | ||
Document Fiscal Year Focus | 2,018 | ||||
Proceeds from Partner of License and Collaborative Agreement | 18,700 | $ 70,600 | |||
Deferred Revenue, Revenue Recognized | 500 | 2,300 | |||
Accounts Receivable, Net, Current | 22,656 | 22,656 | 22,133 | ||
Contract with Customer, Asset, Net | 5,000 | 5,000 | $ 0 | ||
Royalty Revenue | 18,710 | $ 17,119 | 59,643 | $ 45,839 | |
Sales Revenue, Goods, Net | 6,269 | 13,589 | 17,553 | 37,803 | |
License and Services Revenue | 577 | 33,023 | 14,434 | 43,407 | |
Revenues | 25,556 | 63,731 | 91,630 | 127,049 | |
2017 Roche [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Nonrefundable Upfront License Fee Payment Received Under Collaborative Agreement | $ 1,000 | ||||
Roche [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 328,613 | ||||
Baxalta [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 44,438 | ||||
Lilly [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 33,000 | ||||
BMS [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 110,000 | ||||
Alexion [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Nonrefundable Upfront License Fee Payment Received Under Collaborative Agreement | $ 5,000 | ||||
Revenue, Information Used to Allocate Transaction Price | 45,000 | ||||
AbbVie [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 29,000 | ||||
Janssen [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 30,250 | ||||
Pfizer [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 16,500 | ||||
Other collaborators [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Deferred Revenue | 9,800 | $ 9,800 | |||
bulk rHuPH20 [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Sales Revenue, Goods, Net | 2,402 | 9,748 | 6,350 | 26,825 | |
Hylenex Recombinant [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Sales Revenue, Goods, Net | 3,681 | 3,841 | 10,881 | 10,978 | |
Upfront fees [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
License and Services Revenue | 0 | 30,352 | 1,336 | 31,054 | |
Upfront fees [Member] | Roche [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Nonrefundable Upfront License Fee Payment Received Under Collaborative Agreement | $ 25,000 | ||||
Revenue, Information Used to Allocate Transaction Price | 70,000 | ||||
Upfront fees [Member] | Baxalta [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 10,000 | ||||
Upfront fees [Member] | Lilly [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 33,000 | ||||
Upfront fees [Member] | BMS [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 105,000 | ||||
Upfront fees [Member] | Alexion [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 40,000 | ||||
Upfront fees [Member] | AbbVie [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 23,000 | ||||
Upfront fees [Member] | Janssen [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 15,250 | ||||
Upfront fees [Member] | Pfizer [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 14,500 | ||||
Development Fees [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
License and Services Revenue | 0 | 329 | $ 11,000 | 988 | |
Development Fees [Member] | Roche [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 25,000 | ||||
Development Fees [Member] | Baxalta [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 3,000 | ||||
Development Fees [Member] | BMS [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 5,000 | ||||
Development Fees [Member] | Alexion [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Nonrefundable Upfront License Fee Payment Received Under Collaborative Agreement | $ 5,000 | ||||
Revenue, Information Used to Allocate Transaction Price | 5,000 | ||||
Development Fees [Member] | AbbVie [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 6,000 | ||||
Development Fees [Member] | Janssen [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 15,000 | ||||
Development Fees [Member] | Pfizer [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 2,000 | ||||
Sales-based milestone [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
License and Services Revenue | 0 | 342 | $ 0 | 1,028 | |
Sales-based milestone [Member] | Roche [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 22,000 | ||||
Sales-based milestone [Member] | Baxalta [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 9,000 | ||||
Royalty [Member] | Roche [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 211,613 | ||||
Royalty [Member] | Baxalta [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Revenue, Information Used to Allocate Transaction Price | 22,438 | ||||
Research and Development Services [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
License and Services Revenue | 577 | $ 2,000 | $ 2,098 | $ 10,337 | |
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
New Accounting Pronouncement or Change in Accounting Principle, Cumulative Effect of Change on Equity or Net Assets | 71,200 | 71,200 | |||
Contract with Customer, Asset, Net | 19,400 | 19,400 | |||
Accounting Standards Update 2014-09 [Member] | Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | |||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | |||||
Deferred Revenue | (48,700) | (48,700) | |||
Accounts Receivable, Net, Current | 18,700 | 18,700 | |||
Revenues | $ 6,400 | $ 2,600 |
Revenue Revenue Adjustments - 6
Revenue Revenue Adjustments - 606 Implementation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Contract with Customer, Asset, Net | $ 5,000 | $ 5,000 | $ 0 | ||
Revenues | 25,556 | $ 63,731 | 91,630 | $ 127,049 | |
Deferred revenue | (9,754) | (9,754) | (60,865) | ||
Accounts receivable, net | 22,656 | 22,656 | $ 22,133 | ||
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | |||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Contract with Customer, Asset, Net | 19,400 | 19,400 | |||
Contract with Customer, Liability | 51,800 | 51,800 | |||
New Accounting Pronouncement or Change in Accounting Principle, Cumulative Effect of Change on Equity or Net Assets | 71,200 | 71,200 | |||
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | Accounting Standards Update 2014-09 [Member] | |||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||
Revenues | 6,400 | 2,600 | |||
Deferred revenue | 48,700 | 48,700 | |||
Accounts receivable, net | $ 18,700 | $ 18,700 |
Revenue Deferred Revenue Timing
Revenue Deferred Revenue Timing (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Dec. 31, 2017 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Deferred revenue | $ 9,754 | $ 60,865 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-12-31 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Deferred revenue | 4,500 | |
bulk rHuPH20 [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-12-31 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Deferred revenue | 3,000 | |
Alexion [Member] | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Nonrefundable Upfront License Fee Payment Received Under Collaborative Agreement | $ 5,000 |
Revenue Disaggregated Revenue_2
Revenue Disaggregated Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Disaggregation of Revenue [Line Items] | |||||
Contract with Customer, Asset, Net | $ 5,000 | $ 5,000 | $ 0 | ||
Revenues | 25,556 | $ 63,731 | 91,630 | $ 127,049 | |
License and Services Revenue | 577 | 33,023 | 14,434 | 43,407 | |
Royalty Revenue | 18,710 | 17,119 | 59,643 | 45,839 | |
Sales Revenue, Goods, Net | 6,269 | 13,589 | 17,553 | 37,803 | |
bulk rHuPH20 [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Sales Revenue, Goods, Net | 2,402 | 9,748 | 6,350 | 26,825 | |
ENHANZE drug product [Member] [Domain] | |||||
Disaggregation of Revenue [Line Items] | |||||
Sales Revenue, Goods, Net | 186 | 0 | 322 | 0 | |
Hylenex Recombinant [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Sales Revenue, Goods, Net | 3,681 | 3,841 | 10,881 | 10,978 | |
Upfront fees [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
License and Services Revenue | 0 | 30,352 | 1,336 | 31,054 | |
Development Fees [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
License and Services Revenue | 0 | 329 | 11,000 | 988 | |
Sales-based milestone [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
License and Services Revenue | 0 | 342 | 0 | 1,028 | |
Research and Development Services [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
License and Services Revenue | $ 577 | $ 2,000 | 2,098 | $ 10,337 | |
Alexion [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Nonrefundable Upfront License Fee Payment Received Under Collaborative Agreement | 5,000 | ||||
Alexion [Member] | Development Fees [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Nonrefundable Upfront License Fee Payment Received Under Collaborative Agreement | $ 5,000 |
Revenue Performance Obligation
Revenue Performance Obligation (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Deferred Revenue | $ 9,754 | $ 60,865 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-12-31 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Deferred Revenue | 4,500 | |
bulk rHuPH20 [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-12-31 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Deferred Revenue | $ 3,000 |
Certain Balance Sheet Items - A
Certain Balance Sheet Items - Accounts receivable (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Accounts Receivable, Net, Current [Abstract] | ||
Accounts receivable from product sales to collaborators | $ 1,980 | $ 18,475 |
Accounts receivable from revenues under collaborative agreements | 451 | 2,142 |
Accounts receivable from other product sales | 1,949 | 2,075 |
Other contract assets | 5,000 | 0 |
Accounts receivable from royalties | 18,777 | 0 |
Accounts receivable, gross | 28,157 | 22,692 |
Allowance for distribution fees and discounts | (501) | (559) |
Total accounts receivable, net | $ 27,656 | $ 22,133 |
Certain Balance Sheet Items - I
Certain Balance Sheet Items - Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Inventory, Raw Materials | $ 625 | $ 377 |
Inventory, Work in Process | 15,401 | 2,131 |
Inventory, Finished Goods | 2,259 | 2,638 |
Summary of Inventories | ||
Total inventories | $ 18,285 | $ 5,146 |
Certain Balance Sheet Items - P
Certain Balance Sheet Items - Prepaid expenses and other assets (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid manufacturing expenses | $ 8,844 | $ 2,337 |
Prepaid research and development expenses | 9,195 | 7,793 |
Other prepaid expenses | 2,344 | 2,585 |
Other assets | 6,527 | 6,717 |
Total prepaid expense and other assets | 26,910 | 19,432 |
Less long-term portion | 7,291 | 5,553 |
Total prepaid expense and other assets, current | $ 19,619 | $ 13,879 |
Certain Balance Sheet Items -_2
Certain Balance Sheet Items - Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Property and equipment, gross | $ 22,478 | $ 17,410 |
Accumulated depreciation and amortization | (15,688) | (13,890) |
Property and equipment, net | 6,790 | 3,520 |
Research equipment | ||
Property and equipment, gross | 9,528 | 9,268 |
Manufacturing Equipment [Member] [Domain] | ||
Property and equipment, gross | 3,979 | 1,702 |
Computer and office equipment | ||
Property and equipment, gross | 4,811 | 3,725 |
Leasehold improvements | ||
Property and equipment, gross | $ 4,160 | $ 2,715 |
Certain Balance Sheet Items -_3
Certain Balance Sheet Items - Property and Equipment, Net (Textuals) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Depreciation and amortization | ||||
Depreciation and amortization | $ 600 | $ 500 | $ 1,798 | $ 1,668 |
Certain Balance Sheet Items -_4
Certain Balance Sheet Items - Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Summary of Accrued Expenses | ||
Accrued outsourced research and development | $ 19,786 | $ 18,757 |
Accrued compensation and payroll taxes | 12,914 | 13,384 |
Accrued outsourced manufacturing expenses | 4,743 | 2,504 |
Other accrued expenses | 6,142 | 5,396 |
Total accrued expenses | 43,585 | 40,041 |
Less long-term portion | 565 | 440 |
Total accrued expenses, current | $ 43,020 | $ 39,601 |
Certain Balance Sheet Items - D
Certain Balance Sheet Items - Deferred Revenue (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Deferred revenue | ||
Total deferred revenue | $ 9,754 | $ 60,865 |
Less current portion | 4,247 | 6,568 |
Deferred revenue, net of current portion | 5,507 | 54,297 |
Roche [Member] | ||
Deferred revenue | ||
Total deferred revenue | 0 | 39,379 |
Other collaborative agreements | ||
Deferred revenue | ||
Total deferred revenue | 2,265 | 15,999 |
License fees and event-based payments | ||
Deferred revenue | ||
Total deferred revenue | 2,265 | 55,378 |
Product [Member] | ||
Deferred revenue | ||
Total deferred revenue | $ 7,489 | $ 5,487 |
Long-Term Debt, Net Long-Term D
Long-Term Debt, Net Long-Term Debt Textuals (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Mar. 31, 2017 | |
Royalty-backed Loan | ||||||
Debt Instrument [Line Items] | ||||||
Issuance date | Jan. 26, 2016 | |||||
Total loan balance | $ 150,000 | $ 150,000 | ||||
Debt Instrument, Description of Variable Rate Basis | 8.75% plus the three-month LIBOR rate | |||||
Debt, Interest Rate | 10.25% | 10.25% | ||||
Debt Instrument, Maturity Date, Description | final maturity date of the Royalty-backed Loan will be the earlier of (i) the date when principal and interest is paid in full, (ii) the termination of Halozyme Royalty’s right to receive royalties under the Collaboration Agreements, and (iii) December 31, 2050 | |||||
Prepayment fee, percent | 105.00% | 105.00% | ||||
Debt instrument, covenant in compliance | in compliance | |||||
Interest Costs Capitalized | $ 0 | |||||
Accrued Interest | $ 500 | $ 700 | ||||
Lender Fee | $ 1,500 | 1,500 | ||||
Debt Issuance Cost | 400 | 400 | ||||
Interest Expense, debt | 3,100 | $ 4,200 | 10,500 | 12,400 | ||
Outstanding loan balance | 101,000 | 101,000 | ||||
Debt Instrument, Unamortized Discount | 400 | $ 400 | ||||
Maturity date | Dec. 31, 2050 | |||||
Royalty-backed Loan | 2016 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Royalty payments to be applied to debt instrument | 0.00% | |||||
Royalty-backed Loan | 2017 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Royalty payments to be applied to debt instrument | 50.00% | |||||
Royalty-backed Loan | 2018 and thereafter [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Royalty payments to be applied to debt instrument | 100.00% | |||||
Royalty-backed Loan | 2017 Quarterly Maximum Payment [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt Instrument, Periodic Payment | $ 13,750 | |||||
Royalty-backed Loan | 2018 Quarterly Maximum Payment [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt Instrument, Periodic Payment | 18,750 | |||||
Royalty-backed Loan | 2019 Quarterly Maximum Payment [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt Instrument, Periodic Payment | 21,250 | |||||
Royalty-backed Loan | 2020 Quarterly Maximum Payment [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt Instrument, Periodic Payment | $ 22,500 | |||||
Royalty-backed Loan | Minimum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt Instrument, Basis Spread on Variable Rate | 0.70% | |||||
Royalty-backed Loan | Maximum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt Instrument, Basis Spread on Variable Rate | 1.50% | |||||
Secured Debt | ||||||
Debt Instrument [Line Items] | ||||||
Final payment | $ 4,250 | |||||
Senior Loans [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Issuance date | Jun. 7, 2016 | |||||
Total loan balance | 70,000 | $ 70,000 | ||||
Secured debt original draw | $ 55,000 | $ 55,000 | ||||
Interest rate, stated percentage | 8.25% | 8.25% | ||||
Debt instrument, covenant in compliance | in compliance | |||||
Interest Expense, debt | $ 1,200 | $ 1,400 | $ 3,800 | $ 4,100 | ||
Outstanding loan balance | 45,500 | 45,500 | ||||
Debt Instrument, Unamortized Discount | 200 | $ 200 | ||||
Maturity date | Jan. 1, 2021 | |||||
Final payment as percent of original principal | 5.50% | |||||
Debt Instrument, Unused Borrowing Capacity, Amount | 15,000 | $ 15,000 | ||||
Debt Instrument, interest only period | interest only payments for the first 18 months | |||||
Accrued interest, noncurrent | 300 | $ 300 | $ 400 | |||
Accretion of debt balloon payment | $ 2,000 | $ 2,000 | ||||
Senior Loans [Member] | Minimum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Prepayment fee, percent | 1.00% | 1.00% | ||||
Senior Loans [Member] | Maximum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Prepayment fee, percent | 2.00% | 2.00% |
Share-based Compensation (Detai
Share-based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Allocated Share-based Compensation Expense | $ 8,867 | $ 7,762 | $ 26,684 | $ 23,268 |
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Allocated Share-based Compensation Expense | 4,645 | 4,973 | 14,026 | 14,971 |
RSU, RSA, and PRSU awards [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Allocated Share-based Compensation Expense | 4,222 | 2,789 | 12,658 | 8,297 |
Research and Development Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Allocated Share-based Compensation Expense | 4,407 | 3,060 | 13,107 | 9,891 |
Selling, General and Administrative Expenses [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Allocated Share-based Compensation Expense | $ 4,460 | $ 4,702 | $ 13,577 | $ 13,377 |
Share-based Compensation Share-
Share-based Compensation Share-based compensation textuals (Details) - shares shares in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share-based Compensation [Abstract] | ||||
Options, Grants in Period | 0.4 | 0.1 | 2.3 | 2.5 |
Share-based Compensation Shar_2
Share-based Compensation Share-based compensation, valuation (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Schedule of Share-based Compensation Arrangements Valuation Inputs [Line Items] | ||||
Fair Value Assumptions, Weighted Average Expected Term | 5 years 5 months | 5 years 7 months | 5 years 6 months | 5 years 7 months |
Fair Value Assumptions, Expected Dividend Rate | 0.00% | 0.00% | 0.00% | 0.00% |
Fair Value Assumptions, Risk Free Interest Rate, Minimum | 2.75% | 1.73% | 2.25% | 1.73% |
Fair Value Assumptions, Risk Free Interest Rate, Maximum | 2.87% | 1.93% | 2.87% | 1.94% |
Minimum [Member] | ||||
Schedule of Share-based Compensation Arrangements Valuation Inputs [Line Items] | ||||
Fair Value Assumptions, Weighted Average Volatility Rate | 58.60% | 70.50% | 58.70% | 70.50% |
Maximum [Member] | ||||
Schedule of Share-based Compensation Arrangements Valuation Inputs [Line Items] | ||||
Fair Value Assumptions, Weighted Average Volatility Rate | 60.60% | 70.80% | 70.10% | 71.70% |
Share-based Compensation Shar_3
Share-based Compensation Share-based compensation, unrecognized (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2018USD ($) | |
Stock options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Compensation Cost Not yet Recognized | $ 38,966 |
Compensation Cost Not yet Recognized, Period for Recognition | 2 years 5 months 12 days |
RSAs | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Compensation Cost Not yet Recognized | $ 2,743 |
Compensation Cost Not yet Recognized, Period for Recognition | 1 year 1 month 2 days |
RSUs | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Compensation Cost Not yet Recognized | $ 26,434 |
Compensation Cost Not yet Recognized, Period for Recognition | 2 years 2 months 27 days |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) Public Offering (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | 1 Months Ended | 9 Months Ended | |
May 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Equity [Abstract] | |||
Stock Issued During Period, Shares, New Issues | 11.5 | ||
Stock Issued During Period Shares New Issues To Underwriter | 1.5 | ||
Sale of Stock, Price Per Share | $ 12.50 | ||
Proceeds from issuance of common stock, net | $ 134,875 | $ 0 | $ 134,875 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) (Details) - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | |
Stockholders' equity (deficit) (textual) | |||
Outstanding stock options and restricted stock units | 13,400,000 | 14,700,000 | |
Stock options | |||
Stockholders' equity (deficit) (textual) | |||
Number of shares of common stock issued as a result of stock option exercises | 1,280,996 | 1,020,028 | |
Stock options weighted average exercise price | $ 11.13 | $ 8.71 | |
Net proceeds from stock options exercised | $ 14.3 | $ 8.9 | |
Restricted stock units | |||
Stockholders' equity (deficit) (textual) | |||
Stock issued during period, shares, restricted stock award, net of forfeitures | 438,536 | 375,906 | |
Number of RSUs surrendered to pay for minimum withholding taxes | 138,986 | 96,069 | |
Payments for tax withholding for restricted stock units vested, net | $ 4.2 | $ 1.9 | |
Restricted stock awards | |||
Stockholders' equity (deficit) (textual) | |||
Stock issued during period, shares, restricted stock award, net of forfeitures | 67,959 | 98,945 |
Subsequent Event (Details)
Subsequent Event (Details) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2018USD ($) | Sep. 30, 2018USD ($) | |
Subsequent Event [Line Items] | ||
Additional Minimum Proceeds Receivable from Collaborator of License and Collaborative Agreement Upon Achievement of Clinical Development Milestones | $ 160,000 | $ 160,000 |
Recognized revenue in the fourth quarter | 18,700 | 70,600 |
Additional Maximum Proceeds Receivable from Collaborator of License and Collaborative Agreement Upon Achievement of Clinical Development Milestones | $ 165,000 | $ 165,000 |