HALOZYME THERAPEUTICS INC, 10-Q filed on 5/10/2018
Quarterly Report
v3.8.0.1
Document and Entity Information - shares
3 Months Ended
Mar. 31, 2018
May 03, 2018
Document Information [Line Items]    
Entity Registrant Name HALOZYME THERAPEUTICS INC.  
Trading Symbol HALO  
Entity Central Index Key 0001159036  
Document Type 10-Q  
Document Period End Date Mar. 31, 2018  
Amendment Flag false  
Document Fiscal Year Focus 2018  
Document Fiscal Period Focus Q1  
Current Fiscal Year End Date --12-31  
Entity Filer Category Large Accelerated Filer  
Entity Common Stock, Shares Outstanding   143,965,620
v3.8.0.1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Current assets:    
Cash and cash equivalents $ 98,012 $ 168,740
Marketable securities, available-for-sale 335,682 300,474
Accounts receivable, net 26,574 22,133
Inventories 4,393 5,146
Prepaid expenses and other assets 19,809 13,879
Total current assets 484,470 510,372
Property and equipment, net 4,937 3,520
Prepaid expenses and other assets 5,562 5,553
Restricted cash 500 500
Total assets 495,469 519,945
Current liabilities:    
Accounts payable 3,628 7,948
Accrued expenses 31,889 39,601
Deferred revenue, current portion 1,247 6,568
Current portion of long-term debt, net 82,460 77,211
Total current liabilities 119,224 131,328
Deferred revenue, net of current portion 6,006 54,297
Long-term debt, net 102,696 125,140
Other long-term liabilities 2,479 814
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 144 143
Additional paid-in capital 744,359 731,044
Accumulated other comprehensive loss (870) (450)
Accumulated deficit (478,569) (522,371)
Total stockholders' equity (deficit) 265,064 208,366
Total liabilities and stockholders' equity (deficit) $ 495,469 $ 519,945
v3.8.0.1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
shares in Thousands
Mar. 31, 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 143,886 142,789
Common stock, shares outstanding 143,886 142,789
v3.8.0.1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
shares in Thousands, $ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Revenues:    
Product sales, net $ 6,801 $ 11,434
Royalty Revenue 20,944 13,982
License and Services Revenue 3,127 4,152
Total revenues 30,872 29,568
Operating expenses:    
Cost of product sales 3,052 7,544
Research and development 37,976 36,935
Selling, general and administrative 13,556 12,615
Total operating expenses 54,584 57,094
Operating income (loss) (23,712) (27,526)
Other income (expense):    
Investment and other income, net 1,668 287
Interest expense (5,230) (5,448)
Income (loss) before income taxes (27,274) (32,687)
Income tax expense 187 210
Net income (loss) $ (27,461) $ (32,897)
Earnings Per Share, Basic $ (0.19) $ (0.26)
Shares used in computing basic net income (loss) per share 142,656 128,615
v3.8.0.1
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Statement of Comprehensive Income [Abstract]    
Net income (loss) $ (27,461) $ (32,897)
Other comprehensive income (loss):    
Unrealized gain (loss) on marketable securities (418) (40)
Foreign currency translation adjustment (2) (4)
Unrealized loss on foreign currency 0 1
Total comprehensive income (loss) $ (27,881) $ (32,940)
v3.8.0.1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Operating activities:    
Net loss $ (27,461) $ (32,897)
Adjustments to reconcile net loss to net cash used in operating activities:    
Share-based compensation 8,339 7,315
Depreciation and amortization 566 602
Non-cash interest expense 1,352 1,453
(Accretion of discounts) amortization of premiums on marketable securities, net (565) 16
Recognition of deferred revenue (1,834) (1,723)
Recognition of deferred rent (132) 114
Other (2) 39
Changes in operating assets and liabilities:    
Accounts receivable, net 15,044 3,228
Inventories 752 333
Prepaid expenses and other assets (5,939) 4,668
Accounts payable and accrued expenses (12,561) (5,379)
Net cash used in operating activities (22,177) (22,459)
Investing activities:    
Purchases of marketable securities (114,661) (54,830)
Proceeds from maturities of marketable securities 79,600 59,194
Purchases of property and equipment (839) (99)
Net cash used in investing activities (35,900) 4,265
Financing activities:    
Proceeds from issuance of common stock, net 134,875  
Repayment of long-term debt (17,628) (2,989)
Proceeds from issuance of common stock under equity incentive plans, net of taxes paid related to net share settlement 4,977 (393)
Net cash provided by financing activities (12,651) (3,382)
Net increase in cash, cash equivalents and restricted cash (70,728) (21,576)
Cash, cash equivalents and restricted cash beginning of period 169,240 67,264
Cash, cash equivalents and restricted cash end of period $ 98,512 $ 45,688
v3.8.0.1
Organization and Business
3 Months Ended
Mar. 31, 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 complex 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® Technology. 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 (“PEGPH20”, PEGylated recombinant human hyaluronidase), 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 higher 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 HALAVEN® (eribulin) in patients treated with up to two lines of prior therapy for HER2-negative metastatic breast cancer, 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.
v3.8.0.1
Summary of Significant Accounting Policies
3 Months Ended
Mar. 31, 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 March 31, 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 March 31, 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 is recorded as research and development expense. All direct manufacturing costs incurred after receiving 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, 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 March 31, 2018 and December 31, 2017, inventories consisted of $2.9 million of Hylenex recombinant inventory, net and $1.5 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 months ended March 31, 2017 and 2018 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 a 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 record a true-up in the following quarter if necessary, when final royalty reports are received.
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. Similar to our sales of Hylenex recombinant, we use a contract manufacturer to produce bulk rHuPH20 and we concluded we are the principal in the sales to collaboration partners. Transaction price for each purchase order represents the amounts we bill for the shipment of bulk rHuPH20 which are fixed based on the cost of production plus a contractual markup, and are not subject to adjustments. Allocation of the transaction price to individual quantities of the product is usually not required because the entire order is shipped in a single shipment.
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.
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 and bulk rHuPH20 that has alternative future use 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 that has alternative future use and for use in our partners’ approved collaboration products. 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 having alternative future use, all costs related to the manufacturing were charged to research and development expenses in the periods such costs were incurred. There were no costs of bulk rHuPH20 product sales for the three months ended March 31, 2018 that were previously expensed as research and development. Of the bulk rHuPH20 that has alternative future use on hand as of March 31, 2018, approximately $2.7 million in manufacturing costs were previously recorded as research and development expenses. We expect to sell this inventory by the end of 2019.
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 product, 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. We currently have no in-licensed technologies that have alternative future uses in research and development projects or otherwise.
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
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
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.
The Act reduces the U.S. federal corporate tax rate from 35% to 21%. As a result, the Company evaluated and adjusted its deferred tax assets to reflect the new corporate tax rates as of December 31, 2017. The Company is still evaluating other potential impacts and planning opportunities related to tax reform.  As of March 31, 2018, the Company has not implemented any new material planning items and believes that its disclosures in its financial statements as of December 31, 2017 are still reasonably accurate.
Net Loss Per Share
Basic loss per common share is computed by dividing net loss 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. For the three months ended March 31, 2018 and 2017, approximately 14.6 million and 16.4 million shares, respectively, of outstanding stock options, unvested RSAs, unvested RSUs and unvested PRSUs were excluded from the calculation of diluted net loss per common share because a net loss was reported in each of these periods and therefore their effect was anti-dilutive.
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. Our long-lived assets located in foreign countries had minimal book value as of March 31, 2018 and December 31, 2017.
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.

 
 
 
 
 
 
 
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.
 
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. We are currently evaluating the effect the updated standard will have on our consolidated financial statements and related disclosures. We anticipate recognition of additional assets and corresponding liabilities related to our leases on our consolidated balance sheet. This standard will have a material impact on our consolidated financial statements.
v3.8.0.1
Fair Value Measurement (Notes)
3 Months Ended
Mar. 31, 2018
Fair Value Disclosures [Abstract]  
Fair Value Disclosures [Text Block]
Fair Value Measurement
Available-for-sale marketable securities consisted of the following (in thousands):
 
 
March 31, 2018
 
 
Amortized Cost
 
Gross Unrealized Gains
 
Gross Unrealized Losses
 
Estimated Fair Value
 
 
 
 
 
 
 
 
 
Asset-backed securities
 
$
8,957

 
$

 
$
(9
)
 
$
8,948

Corporate debt securities
 
121,341

 

 
(478
)
 
120,863

U.S. Treasury securities
 
99,265

 

 
(367
)
 
98,898

Commercial paper
 
106,973

 

 

 
106,973

 
 
$
336,536

 
$

 
$
(854
)
 
$
335,682


 
 
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 March 31, 2018, 30 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 March 31, 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.
Contractual maturities of available-for-sale debt securities are as follows (in thousands):
 
 
March 31, 2018
 
 
Estimated Fair Value
Due within one year
 
$
301,637

After one but within five years
 
34,045

 
 
$
335,682


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):
 
 
March 31, 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
 
$
75,621

 
$

 
$
75,621

 
$
142,091

 
$

 
$
142,091

Commercial paper
 

 
8,000

 
8,000

 

 
15,700

 
15,700

 
 
 
 
 
 
 
 
 
 
 
 
 
Available-for-sale marketable
   securities:
 
 
 
 
 
 
 
 
 
 
 
 
Asset-backed securities
 

 
8,948

 
8,948

 

 

 

Corporate debt securities
 

 
120,863

 
120,863

 

 
117,192

 
117,192

U.S. Treasury securities
 
98,898

 

 
98,898

 
66,400

 

 
66,400

Commercial paper
 

 
106,973

 
106,973

 

 
116,882

 
116,882

 
 
$
174,519

 
$
244,784

 
$
419,303

 
$
208,491

 
$
249,774

 
$
458,265


There were no transfers between Level 1 and Level 2 of the fair value hierarchy during the three months ended March 31, 2018. We had no instruments that were classified within Level 3 as of March 31, 2018 and December 31, 2017.
v3.8.0.1
Revenue (Notes)
3 Months Ended
Mar. 31, 2018
Deferred Revenue Disclosure [Abstract]  
Collaborative Agreements
Our disaggregated revenues were as follows (in thousands):
 
 
Three Months Ended
March 31,
 
 
2018
 
2017
Royalties
 
$
20,944

 
$
13,982

 
 
 
 
 
Product sales, net
 
 
 
 
  Sales of bulk rHuPH20
 
$
3,378

 
$
8,229

  Sales of Hylenex
 
3,423

 
3,205

Total product sales, net
 
6,801

 
11,434

 
 
 
 
 
Revenues under collaborative agreements:
 
 
 
 
  Upfront license fees
 
1,336

 
351

  Event-based development milestones and other fees
 
1,000

 
672

  Research and development services
 
791

 
3,129

Total revenues under collaborative agreements
 
3,127

 
4,152

 
 
 
 
 
Total revenue
 
$
30,872

 
$
29,568


During the three months ended March 31, 2018 we recognized revenue related to licenses granted to collaboration partners in prior periods in the amount of $21.9 million. This amount represents royalties earned in the current period, in addition to the achievement of a development milestone of $1.0 million by Roche. We also recognized revenue of $1.8 million 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 months ended March 31, 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 months ended March 31, 2018 was to increase revenues by $1.1 million. Under the previously existing authoritative accounting literature, at March 31, 2018 our accounts receivable would have been $20.9 million lower, and our deferred revenue$51.4 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 and deferred revenues (contract liabilities) from contracts with customers, including collaboration partners, consisted of the following (in thousands):
 
 
March 31, 2018
 
December 31, 2017
Accounts receivable, net
 
$
26,574

 
$
22,133

Deferred revenues
 
7,253

 
60,865


As of March 31, 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 $7.3 million. This amount has been collected and is reported as deferred revenues. The timing of when these goods and services will be provided is controlled by our customers. Of the total deferred revenues, $5.0 million can be used by the customers at any time through 2022 and the remaining $2.3 million at any time through 2019.
There were no contract assets related to collaborative agreements recognized during the three months ended March 31, 2018. While we may become entitled to receive additional event-based development and regulatory milestones and other fees under our collaborative agreements, which relate to intellectual property licenses granted to collaboration partners in prior periods, no amounts were probable. The following table presents amounts under our collaborative agreements included in transaction price (i.e. cumulative amounts triggered or probable) as of March 31, 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

 
$
176,943

 
$
293,943

Baxalta (September 2007)
 
10,000

 
3,000

 
9,000

 
18,409

 
40,409

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

 

 

 

 
105,000

Alexion (December 2017)
 
40,000

 

 

 

 
40,000


(1)
Upfront and additional target selection fees
(2)
Event-based development and regulatory milestone amounts and other fees
(3)
Sales-based milestone amounts
Through March 31, 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;
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.
v3.8.0.1
Certain Balance Sheet Items (Notes)
3 Months Ended
Mar. 31, 2018
Balance Sheet Related Disclosures [Abstract]  
Certain Balance Sheet Items
Certain Balance Sheet Items
Accounts receivable, net consisted of the following (in thousands):
 
 
March 31,
2018
 
December 31,
2017
Accounts receivable from product sales to collaborators
 
$
2,881

 
$
18,475

Accounts receivable from revenues under collaborative agreements
 
1,296

 
2,142

Accounts receivable from royalty payments
 
20,944

 

Accounts receivable from other product sales
 
1,950

 
2,075

     Subtotal
 
27,071

 
22,692

Allowance for distribution fees and discounts
 
(497
)
 
(559
)
     Total accounts receivable, net
 
$
26,574

 
$
22,133


Inventories consisted of the following (in thousands):
 
 
March 31,
2018
 
December 31,
2017
Raw materials
 
$
357

 
$
377

Work-in-process
 
2,641

 
2,131

Finished goods
 
1,395

 
2,638

     Total inventories
 
$
4,393

 
$
5,146


Prepaid expenses and other assets consisted of the following (in thousands):
 
 
March 31,
2018
 
December 31,
2017
Prepaid manufacturing expenses
 
$
9,085

 
$
2,337

Prepaid research and development expenses
 
7,488

 
7,793

Other prepaid expenses
 
2,150

 
2,585

Other assets
 
6,648

 
6,717

     Total prepaid expenses and other assets
 
25,371

 
19,432

Less long-term portion
 
5,562

 
5,553

     Total prepaid expenses and other assets, current
 
$
19,809

 
$
13,879


Prepaid manufacturing expenses include slot reservation fees and other amounts paid to contract manufacturing organizations. Such amounts are reclassified to work-in-process inventory once the manufacturing process has commenced.
Property and equipment, net consisted of the following (in thousands):
 
 
March 31,
2018
 
December 31,
2017
Research equipment
 
$
11,132

 
$
10,970

Computer and office equipment
 
4,176

 
3,725

Leasehold improvements
 
4,085

 
2,715

     Subtotal
 
19,393

 
17,410

Accumulated depreciation and amortization
 
(14,456
)
 
(13,890
)
     Property and equipment, net
 
$
4,937

 
$
3,520

Depreciation and amortization expense totaled $0.6 million for the three months ended March 31, 2018 and 2017, respectively.
Accrued expenses consisted of the following (in thousands):
 
 
March 31,
2018
 
December 31,
2017
Accrued outsourced research and development expenses
 
$
17,863

 
$
18,757

Accrued compensation and payroll taxes
 
5,529

 
13,384

Accrued outsourced manufacturing expenses
 
2,933

 
2,504

Other accrued expenses
 
6,201

 
5,396

     Total accrued expenses
 
32,526

 
40,041

Less long-term portion
 
637

 
440

     Total accrued expenses, current
 
$
31,889

 
$
39,601


Deferred revenue consisted of the following (in thousands):
 
 
March 31,
2018
 
December 31,
2017
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
 
4,988

 
5,487

Total deferred revenue
 
7,253

 
60,865

Less current portion
 
1,247

 
6,568

Deferred revenue, net of current portion
 
$
6,006

 
$
54,297

v3.8.0.1
Long-Term Debt, Net (Notes)
3 Months Ended
Mar. 31, 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 March 31, 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 March 31, 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 months ended March 31, 2018. In addition, we recorded accrued interest, which is included in accrued expenses, of $0.6 million and $0.7 million as of March 31, 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 March 31, 2018, and are being amortized over the estimated term of the debt using the effective interest method. For the three months ended March 31, 2018 and 2017, the Company recognized interest expense, including amortization of the debt discount, related to the Royalty-backed Loan of $3.9 million and $4.0 million, 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 March 31, 2018 was $131.8 million, net of unamortized debt discount of $0.6 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 carry an interest rate of 8.25% and 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 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 March 31, 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 $1.4 million for the three months ended March 31, 2018 and 2017, respectively. Accrued interest, which is included in accrued expenses, was $0.4 million as of March 31, 2018 and December 31, 2017, respectively. The outstanding term loan balance was $53.4 million as of March 31, 2018, inclusive of $1.6 million of accretion of the final payment and net of unamortized debt discount related to offering costs of $0.4 million.
v3.8.0.1
Share-based Compensation (Notes)
3 Months Ended
Mar. 31, 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
March 31,
 
 
2018
 
2017
Research and development
 
$
3,914

 
$
3,274

Selling, general and administrative
 
4,425

 
4,041

Share-based compensation expense
 
$
8,339

 
$
7,315


Share-based compensation expense by type of share-based award (in thousands):
 
 
Three Months Ended
March 31,
 
 
2018
 
2017
Stock options
 
$
4,559

 
$
4,749

RSAs, RSUs and PRSUs
 
3,780

 
2,566

 
 
$
8,339

 
$
7,315


We granted stock options to purchase approximately 1.6 million and 2.2 million shares of common stock during the three months ended March 31, 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
March 31,
 
 
2018
 
2017
Expected volatility
 
62.61-70.06%
 
71.0-71.7%
Average expected term (in years)
 
5.5
 
5.6
Risk-free interest rate
 
2.25-2.65%
 
1.92-1.94%
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):
 
 
March 31, 2018
 
 
Unrecognized
Expense
 
Remaining
Weighted-Average
Recognition Period
(years)
Stock options
 
$
46,233

 
2.58
RSAs
 
$
3,434

 
1.33
RSUs
 
$
36,667

 
2.70
v3.8.0.1
Stockholders' Equity (Deficit)
3 Months Ended
Mar. 31, 2018
Equity [Abstract]  
Stockholders' Equity (Deficit)
Stockholders’ Equity (Deficit)
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 three months ended March 31, 2018 and 2017, we issued an aggregate of 705,856 and 74,522 shares of common stock, respectively, in connection with the exercises of stock options at a weighted average exercise price of $10.47 and $7.78 per share, respectively, for net proceeds of approximately $7.4 million and $0.6 million, respectively. For the three months ended March 31, 2018 and 2017, we issued 410,306 and 252,305 shares of common stock, respectively, upon vesting of certain RSUs for which the RSU holders surrendered 129,465 and 79,499 RSUs, respectively, to pay for minimum withholding taxes totaling approximately $2.4 million and $1.7 million, respectively. In addition, we did not cancel any shares of common stock in connection with the grants of RSAs during the three months ended March 31, 2018 and 2017, respectively. Stock options and unvested restricted units totaling approximately 14.1 million shares and 13.0 million shares of our common stock were outstanding as of March 31, 2018 and December 31, 2017, respectively.
v3.8.0.1
Commitments and Contingencies
3 Months Ended
Mar. 31, 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.
v3.8.0.1
Summary of Significant Accounting Policies (Policies)
3 Months Ended
Mar. 31, 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 March 31, 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 is recorded as research and development expense. All direct manufacturing costs incurred after receiving 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, 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 months ended March 31, 2017 and 2018 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 a 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 record a true-up in the following quarter if necessary, when final royalty reports are received.
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. Similar to our sales of Hylenex recombinant, we use a contract manufacturer to produce bulk rHuPH20 and we concluded we are the principal in the sales to collaboration partners. Transaction price for each purchase order represents the amounts we bill for the shipment of bulk rHuPH20 which are fixed based on the cost of production plus a contractual markup, and are not subject to adjustments. Allocation of the transaction price to individual quantities of the product is usually not required because the entire order is shipped in a single shipment.
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.
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 and bulk rHuPH20 that has alternative future use 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 that has alternative future use and for use in our partners’ approved collaboration products. 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 product, 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 Per Share
Basic loss per common share is computed by dividing net loss 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.

 
 
 
 
 
 
 
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.
 
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. We are currently evaluating the effect the updated standard will have on our consolidated financial statements and related disclosures. We anticipate recognition of additional assets and corresponding liabilities related to our leases on our consolidated balance sheet. This standard will have a material impact on our consolidated financial statements.
v3.8.0.1
Summary of Significant Accounting Policies (Tables)
3 Months Ended
Mar. 31, 2018
Accounting Policies [Abstract]  
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]
v3.8.0.1
Fair Value Measurement (Tables)
3 Months Ended
Mar. 31, 2018
Fair Value Disclosures [Abstract]  
Investments Classified by Contractual Maturity Date [Table Text Block]
Contractual maturities of available-for-sale debt securities are as follows (in thousands):
 
 
March 31, 2018
 
 
Estimated Fair Value
Due within one year
 
$
301,637

After one but within five years
 
34,045

 
 
$
335,682

Available-for-sale marketable securities
Available-for-sale marketable securities consisted of the following (in thousands):
 
 
March 31, 2018
 
 
Amortized Cost
 
Gross Unrealized Gains
 
Gross Unrealized Losses
 
Estimated Fair Value
 
 
 
 
 
 
 
 
 
Asset-backed securities
 
$
8,957

 
$

 
$
(9
)
 
$
8,948

Corporate debt securities
 
121,341

 

 
(478
)
 
120,863

U.S. Treasury securities
 
99,265

 

 
(367
)
 
98,898

Commercial paper
 
106,973

 

 

 
106,973

 
 
$
336,536

 
$

 
$
(854
)
 
$
335,682


 
 
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):
 
 
March 31, 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
 
$
75,621

 
$

 
$
75,621

 
$
142,091

 
$

 
$
142,091

Commercial paper
 

 
8,000

 
8,000

 

 
15,700

 
15,700

 
 
 
 
 
 
 
 
 
 
 
 
 
Available-for-sale marketable
   securities:
 
 
 
 
 
 
 
 
 
 
 
 
Asset-backed securities
 

 
8,948

 
8,948

 

 

 

Corporate debt securities
 

 
120,863

 
120,863

 

 
117,192

 
117,192

U.S. Treasury securities
 
98,898

 

 
98,898

 
66,400

 

 
66,400

Commercial paper
 

 
106,973

 
106,973

 

 
116,882

 
116,882

 
 
$
174,519

 
$
244,784

 
$
419,303

 
$
208,491

 
$
249,774

 
$
458,265

v3.8.0.1
Revenue Collaborative Agreements (Tables)
3 Months Ended
Mar. 31, 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
March 31,
 
 
2018
 
2017
Royalties
 
$
20,944

 
$
13,982

 
 
 
 
 
Product sales, net
 
 
 
 
  Sales of bulk rHuPH20
 
$
3,378

 
$
8,229

  Sales of Hylenex
 
3,423

 
3,205

Total product sales, net
 
6,801

 
11,434

 
 
 
 
 
Revenues under collaborative agreements:
 
 
 
 
  Upfront license fees
 
1,336

 
351

  Event-based development milestones and other fees
 
1,000

 
672

  Research and development services
 
791

 
3,129

Total revenues under collaborative agreements
 
3,127

 
4,152

 
 
 
 
 
Total revenue
 
$
30,872

 
$
29,568

Contract with Customer, Asset and Liability [Table Text Block]
Accounts receivable, net and deferred revenues (contract liabilities) from contracts with customers, including collaboration partners, consisted of the following (in thousands):
 
 
March 31, 2018
 
December 31, 2017
Accounts receivable, net
 
$
26,574

 
$
22,133

Deferred revenues
 
7,253

 
60,865

Other collaborators [Member]  
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]  
Revenue Recognition, Multiple-deliverable Arrangements [Table Text Block]
There were no contract assets related to collaborative agreements recognized during the three months ended March 31, 2018. While we may become entitled to receive additional event-based development and regulatory milestones and other fees under our collaborative agreements, which relate to intellectual property licenses granted to collaboration partners in prior periods, no amounts were probable. The following table presents amounts under our collaborative agreements included in transaction price (i.e. cumulative amounts triggered or probable) as of March 31, 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

 
$
176,943

 
$
293,943

Baxalta (September 2007)
 
10,000

 
3,000

 
9,000

 
18,409

 
40,409

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

 

 

 

 
105,000

Alexion (December 2017)
 
40,000

 

 

 

 
40,000

v3.8.0.1
Revenue Disaggregated Revenue (Tables)
3 Months Ended
Mar. 31, 2018
Revenue from Contract with Customer [Abstract]  
Disaggregation of Revenue [Table Text Block]
Our disaggregated revenues were as follows (in thousands):
 
 
Three Months Ended
March 31,
 
 
2018
 
2017
Royalties
 
$
20,944

 
$
13,982

 
 
 
 
 
Product sales, net
 
 
 
 
  Sales of bulk rHuPH20
 
$
3,378

 
$
8,229

  Sales of Hylenex
 
3,423

 
3,205

Total product sales, net
 
6,801

 
11,434

 
 
 
 
 
Revenues under collaborative agreements:
 
 
 
 
  Upfront license fees
 
1,336

 
351

  Event-based development milestones and other fees
 
1,000

 
672

  Research and development services
 
791

 
3,129

Total revenues under collaborative agreements
 
3,127

 
4,152

 
 
 
 
 
Total revenue
 
$
30,872

 
$
29,568

v3.8.0.1
Certain Balance Sheet Items (Tables)
3 Months Ended
Mar. 31, 2018
Balance Sheet Related Disclosures [Abstract]  
Summary of Accounts Receivable
Accounts receivable, net consisted of the following (in thousands):
 
 
March 31,
2018
 
December 31,
2017
Accounts receivable from product sales to collaborators
 
$
2,881

 
$
18,475

Accounts receivable from revenues under collaborative agreements
 
1,296

 
2,142

Accounts receivable from royalty payments
 
20,944

 

Accounts receivable from other product sales
 
1,950

 
2,075

     Subtotal
 
27,071

 
22,692

Allowance for distribution fees and discounts
 
(497
)
 
(559
)
     Total accounts receivable, net
 
$
26,574

 
$
22,133

Summary of Inventories
Inventories consisted of the following (in thousands):
 
 
March 31,
2018
 
December 31,
2017
Raw materials
 
$
357

 
$
377

Work-in-process
 
2,641

 
2,131

Finished goods
 
1,395

 
2,638

     Total inventories
 
$
4,393

 
$
5,146

Summary of Prepaid Expenses and Other Assets
Prepaid expenses and other assets consisted of the following (in thousands):
 
 
March 31,
2018
 
December 31,
2017
Prepaid manufacturing expenses
 
$
9,085

 
$
2,337

Prepaid research and development expenses
 
7,488

 
7,793

Other prepaid expenses
 
2,150

 
2,585

Other assets
 
6,648

 
6,717

     Total prepaid expenses and other assets
 
25,371

 
19,432

Less long-term portion
 
5,562

 
5,553

     Total prepaid expenses and other assets, current
 
$
19,809

 
$
13,879

Summary of Property and Equipment
Property and equipment, net consisted of the following (in thousands):
 
 
March 31,
2018
 
December 31,
2017
Research equipment
 
$
11,132

 
$
10,970

Computer and office equipment
 
4,176

 
3,725

Leasehold improvements
 
4,085

 
2,715

     Subtotal
 
19,393

 
17,410

Accumulated depreciation and amortization
 
(14,456
)
 
(13,890
)
     Property and equipment, net
 
$
4,937

 
$
3,520

Summary of Accrued Expenses
Accrued expenses consisted of the following (in thousands):
 
 
March 31,
2018
 
December 31,
2017
Accrued outsourced research and development expenses
 
$
17,863

 
$
18,757

Accrued compensation and payroll taxes
 
5,529

 
13,384

Accrued outsourced manufacturing expenses
 
2,933

 
2,504

Other accrued expenses
 
6,201

 
5,396

     Total accrued expenses
 
32,526

 
40,041

Less long-term portion
 
637

 
440

     Total accrued expenses, current
 
$
31,889

 
$
39,601

Summary of Deferred Revenue
Deferred revenue consisted of the following (in thousands):
 
 
March 31,
2018
 
December 31,
2017
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
 
4,988

 
5,487

Total deferred revenue
 
7,253

 
60,865

Less current portion
 
1,247

 
6,568

Deferred revenue, net of current portion
 
$
6,006

 
$
54,297

v3.8.0.1
Share-based Compensation (Tables)
3 Months Ended
Mar. 31, 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
March 31,
 
 
2018
 
2017
Research and development
 
$
3,914

 
$
3,274

Selling, general and administrative
 
4,425

 
4,041

Share-based compensation expense
 
$
8,339

 
$
7,315

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
March 31,
 
 
2018
 
2017
Stock options
 
$
4,559

 
$
4,749

RSAs, RSUs and PRSUs
 
3,780

 
2,566

 
 
$
8,339

 
$
7,315

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
March 31,
 
 
2018
 
2017
Expected volatility
 
62.61-70.06%
 
71.0-71.7%
Average expected term (in years)
 
5.5
 
5.6
Risk-free interest rate
 
2.25-2.65%
 
1.92-1.94%
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):
 
 
March 31, 2018
 
 
Unrecognized
Expense
 
Remaining
Weighted-Average
Recognition Period
(years)
Stock options
 
$
46,233

 
2.58
RSAs
 
$
3,434

 
1.33
RSUs
 
$
36,667

 
2.70
v3.8.0.1
Summary of Significant Accounting Policies Restricted Cash (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Restricted Cash and Investments, Current [Abstract]    
Restricted cash $ 500 $ 500
v3.8.0.1
Summary of Significant Accounting Policies Inventories (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Inventory [Line Items]    
Inventory, Net $ 4,393 $ 5,146
Hylenex Recombinant [Member]    
Inventory [Line Items]    
Inventory, Net 2,900 2,900
bulk rHuPH20    
Inventory [Line Items]    
Inventory, Net 1,500 $ 2,200
Costs expensed to R&D [Domain]    
Inventory [Line Items]    
Inventory, Net $ 2,700  
v3.8.0.1
Summary of Significant Accounting Policies Research and development (Details) - USD ($)
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Research and Development Arrangement, Contract to Perform for Others [Line Items]    
Research and Development Expense $ 37,976,000 $ 36,935,000
In-license technologies [Member]    
Research and Development Arrangement, Contract to Perform for Others [Line Items]    
Research and Development Expense $ 0  
v3.8.0.1
Summary of Significant Accounting Policies Income tax (Details) - USD ($)
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Income Tax Disclosure [Abstract]    
Deferred Tax Assets, Net $ 0  
Income tax expense $ 187,000 $ 210,000
v3.8.0.1
Summary of Significant Accounting Policies Net Loss Per Share (Details) - USD ($)
$ / shares in Units, shares in Thousands, $ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Loss Per Share Disclosure [Line Items]    
Net income (loss) $ (27,461) $ (32,897)
Weighted Average Number of Shares Outstanding, Basic 142,656 128,615
Earnings Per Share, Basic $ (0.19) $ (0.26)
Net loss per share (Textuals) [Abstract]    
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 14,600 16,400
v3.8.0.1
Summary of Significant Accounting Policies Segment information (Details)
3 Months Ended
Mar. 31, 2018
Segment
Segment Reporting [Abstract]  
Number of Operating Segments 1
v3.8.0.1
Summary of Significant Accounting Policies Adoption of Recent Accounting Pronouncements (Details) - USD ($)
$ in Millions
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
New Accounting Pronouncements and Changes in Accounting Principles [Abstract]    
Reclassification of restricted cash $ 0.5 $ 0.5
v3.8.0.1
Fair Value Measurement (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Schedule of Available-for-sale Securities    
Amortized cost $ 336,536 $ 300,910
Gross Unrealized Gains 0 0
Gross Unrealized Losses (854) (436)
Estimated fair value 335,682 300,474
Asset-backed Securities [Member]    
Schedule of Available-for-sale Securities    
Amortized cost 8,957  
Gross Unrealized Gains 0  
Gross Unrealized Losses (9)  
Estimated fair value 8,948  
Corporate Debt Securities [Member]    
Schedule of Available-for-sale Securities    
Amortized cost 121,341 117,427
Gross Unrealized Gains 0 0
Gross Unrealized Losses (478) (235)
Estimated fair value 120,863 117,192
US Treasury Securities [Member]    
Schedule of Available-for-sale Securities    
Amortized cost 99,265 66,601
Gross Unrealized Gains 0 0
Gross Unrealized Losses (367) (201)
Estimated fair value 98,898 66,400
Commercial Paper [Member]    
Schedule of Available-for-sale Securities    
Amortized cost 106,973 116,882
Gross Unrealized Gains 0 0
Gross Unrealized Losses 0 0
Estimated fair value $ 106,973 $ 116,882
v3.8.0.1
Fair Value Measurement Textuals (Details)
$ in Thousands
3 Months Ended
Mar. 31, 2018
USD ($)
Dec. 31, 2017
USD ($)
Fair Value Disclosures [Abstract]    
Investments Classified by Contractual Maturity Date [Table Text Block]   $ 301,637
Number of available-for-sale securities in unrealized loss position, less than one year 30  
Other than Temporary Impairment Losses, Marketable Securities $ 0  
v3.8.0.1
Fair Value Measurement Fair Value Measures (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]    
Assets, Fair Value Disclosure $ 419,303 $ 458,265
Available-for-sale Securities 335,682 300,474
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 75,621 142,091
US Treasury Securities [Member]    
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]    
Available-for-sale Securities 98,898 66,400
Commercial Paper [Member]    
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]    
Cash and Cash Equivalents, Fair Value Disclosure 8,000 15,700
Available-for-sale Securities 106,973 116,882
Corporate Debt Securities [Member]    
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]    
Available-for-sale Securities 120,863 117,192
Fair Value, Inputs, Level 1 [Member]    
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]    
Assets, Fair Value Disclosure 174,519 208,491
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 75,621 142,091
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member]    
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]    
Available-for-sale Securities 98,898 66,400
Fair Value, Inputs, Level 2 [Member]    
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]    
Assets, Fair Value Disclosure 244,784 249,774
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 8,000 15,700
Available-for-sale Securities 106,973 116,882
Fair Value, Inputs, Level 2 [Member] | Corporate Debt Securities [Member]    
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]    
Available-for-sale Securities 120,863 117,192
Fair Value, Inputs, Level 2 [Member] | Asset-backed Securities [Member]    
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]    
Available-for-sale Securities 8,948  
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 $ 8,948  
v3.8.0.1
Fair Value Measurement Maturities (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Fair Value Disclosures [Abstract]    
Investments Classified by Contractual Maturity Date [Table Text Block]   $ 301,637
Available-for-sale Securities, Debt Maturities, Rolling Year Two Through Five, Fair Value $ 34,045  
Available-for-sale Securities $ 335,682 $ 300,474
v3.8.0.1
Revenue Collaborative Agreements Textuals (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Dec. 31, 2017
Deferred Revenue (Textual) [Abstract]    
Deferred Revenue $ 7,253 $ 60,865
Collaborative Agreements (Textual)    
Deferred Revenue, Revenue Recognized 1,800  
Roche [Member]    
Deferred Revenue (Textual) [Abstract]    
Deferred Revenue 0 $ 39,379
2017 Roche [Member]    
Deferred Revenue (Textual) [Abstract]    
Nonrefundable Upfront License Fee Payment Received Under Collaborative Agreement $ 1,000  
v3.8.0.1
Revenue Collaborative Agreements tables (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Dec. 31, 2017
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Deferred Revenue $ 7,253   $ 60,865
Document Fiscal Year Focus 2018    
Proceeds from Partner of License and Collaborative Agreement $ 21,900    
Deferred Revenue, Revenue Recognized 1,800    
Accounts Receivable, Net, Current 26,574   $ 22,133
Royalty Revenue 20,944 $ 13,982  
Sales Revenue, Goods, Net 6,801 11,434  
License and Services Revenue 3,127 4,152  
Revenues 30,872 29,568  
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 293943    
Baxalta [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 40409    
Lilly [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 33000    
BMS [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 105000    
Alexion [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 40000    
AbbVie [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 29000    
Janssen [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 30250    
Pfizer [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 16500    
Other collaborators [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Deferred Revenue $ 7,300    
Upfront fees [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
License and Services Revenue $ 1,336 351  
Upfront fees [Member] | Roche [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 70000    
Upfront fees [Member] | Baxalta [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 10000    
Upfront fees [Member] | Lilly [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 33000    
Upfront fees [Member] | BMS [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 105000    
Upfront fees [Member] | Alexion [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 40000    
Upfront fees [Member] | AbbVie [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 23000    
Upfront fees [Member] | Janssen [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 15250    
Upfront fees [Member] | Pfizer [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 14500    
Development Fees [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
License and Services Revenue $ 1,000 672  
Development Fees [Member] | Roche [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 25000    
Development Fees [Member] | Baxalta [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 3000    
Development Fees [Member] | AbbVie [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 6000    
Development Fees [Member] | Janssen [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 15000    
Development Fees [Member] | Pfizer [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 2000    
Sales-based milestone [Member] | Roche [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 22000    
Sales-based milestone [Member] | Baxalta [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 9000    
Royalty [Member] | Roche [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 176943    
Royalty [Member] | Baxalta [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Revenue, Information Used to Allocate Transaction Price 18409    
Research and Development Services [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
License and Services Revenue $ 791 3,129  
bulk rHuPH20 [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Sales Revenue, Goods, Net 3,378 8,229  
Hylenex Recombinant [Member]      
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]      
Sales Revenue, Goods, Net 3,423 $ 3,205  
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    
v3.8.0.1
Revenue Revenue Adjustments - 606 Implementation (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Dec. 31, 2017
Revenue, Initial Application Period Cumulative Effect Transition [Line Items]      
Revenues $ 30,872 $ 29,568  
Deferred revenue (7,253)   $ (60,865)
Accounts receivable, net 26,574   $ 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    
Contract with Customer, Liability 51,800    
New Accounting Pronouncement or Change in Accounting Principle, Cumulative Effect of Change on Equity or Net Assets 71,200    
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | ASU No. 2014-09 [Member]      
Revenue, Initial Application Period Cumulative Effect Transition [Line Items]      
Revenues 1,100    
Deferred revenue 51,400    
Accounts receivable, net $ 20,900    
v3.8.0.1
Revenue Deferred Revenue Timing (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items]    
Deferred revenue $ 7,253 $ 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 2,300  
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2022-12-31    
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items]    
Deferred revenue $ 5,000  
v3.8.0.1
Revenue Disaggregated Revenue (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Disaggregation of Revenue [Line Items]    
Revenues $ 30,872 $ 29,568
License and Services Revenue 3,127 4,152
Royalty Revenue 20,944 13,982
Sales Revenue, Goods, Net 6,801 11,434
bulk rHuPH20 [Member]    
Disaggregation of Revenue [Line Items]    
Sales Revenue, Goods, Net 3,378 8,229
Hylenex Recombinant [Member]    
Disaggregation of Revenue [Line Items]    
Sales Revenue, Goods, Net 3,423 3,205
Upfront fees [Member]    
Disaggregation of Revenue [Line Items]    
License and Services Revenue 1,336 351
Development Fees [Member]    
Disaggregation of Revenue [Line Items]    
License and Services Revenue 1,000 672
Research and Development Services [Member]    
Disaggregation of Revenue [Line Items]    
License and Services Revenue $ 791 $ 3,129
v3.8.0.1
Certain Balance Sheet Items - Accounts receivable (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Accounts Receivable, Net, Current [Abstract]    
Accounts receivable from product sales to collaborators $ 2,881 $ 18,475
Accounts receivable from revenues under collaborative agreements 1,296 2,142
Accounts receivable from other product sales 1,950 2,075
Accounts receivable from royalties 20,944 0
Accounts receivable, gross 27,071 22,692
Allowance for distribution fees and discounts (497) (559)
Total accounts receivable, net $ 26,574 $ 22,133
v3.8.0.1
Certain Balance Sheet Items - Inventories (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Inventory Disclosure [Abstract]    
Inventory, Raw Materials $ 357 $ 377
Inventory, Work in Process 2,641 2,131
Inventory, Finished Goods 1,395 2,638
Summary of Inventories    
Total inventories $ 4,393 $ 5,146
v3.8.0.1
Certain Balance Sheet Items - Prepaid expenses and other assets (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Prepaid Expense and Other Assets, Current [Abstract]    
Prepaid manufacturing expenses $ 9,085 $ 2,337
Prepaid research and development expenses 7,488 7,793
Other prepaid expenses 2,150 2,585
Other assets 6,648 6,717
Total prepaid expense and other assets 25,371 19,432
Less long-term portion 5,562 5,553
Total prepaid expense and other assets, current $ 19,809 $ 13,879
v3.8.0.1
Certain Balance Sheet Items - Property and Equipment (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Property and equipment, gross $ 19,393 $ 17,410
Accumulated depreciation and amortization (14,456) (13,890)
Property and equipment, net 4,937 3,520
Research equipment    
Property and equipment, gross 11,132 10,970
Computer and office equipment    
Property and equipment, gross 4,176 3,725
Leasehold improvements    
Property and equipment, gross $ 4,085 $ 2,715
v3.8.0.1
Certain Balance Sheet Items - Property and Equipment, Net (Textuals) (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Depreciation and amortization    
Depreciation and amortization $ 566 $ 602
v3.8.0.1
Certain Balance Sheet Items - Accrued Expenses (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Summary of Accrued Expenses    
Accrued outsourced research and development $ 17,863 $ 18,757
Accrued compensation and payroll taxes 5,529 13,384
Accrued outsourced manufacturing expenses 2,933 2,504
Other accrued expenses 6,201 5,396
Total accrued expenses 32,526 40,041
Less long-term portion 637 440
Total accrued expenses, current $ 31,889 $ 39,601
v3.8.0.1
Certain Balance Sheet Items - Deferred Revenue (Details) - USD ($)
$ in Thousands
Mar. 31, 2018
Dec. 31, 2017
Deferred revenue    
Total deferred revenue $ 7,253 $ 60,865
Less current portion 1,247 6,568
Deferred revenue, net of current portion 6,006 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 $ 4,988 $ 5,487
v3.8.0.1
Long-Term Debt, Net Long-Term Debt Textuals (Details) - USD ($)
$ in Thousands
3 Months Ended 12 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Dec. 31, 2017
Royalty-backed Loan      
Debt Instrument [Line Items]      
Issuance date Jan. 26, 2016    
Total loan balance $ 150,000    
Debt Instrument, Description of Variable Rate Basis 8.75% plus the three-month LIBOR rate    
Debt, Interest Rate 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%    
Debt instrument, covenant in compliance in compliance    
Interest Costs Capitalized   $ 0  
Accrued Interest $ 600   $ 700
Lender Fee 1,500    
Debt Issuance Cost 400    
Interest Expense, debt 3,900 4,000  
Outstanding loan balance 131,800    
Debt Instrument, Unamortized Discount $ 600    
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]      
Interest Expense, debt   1,400  
Final payment   $ 4,250  
Senior Loans [Member]      
Debt Instrument [Line Items]      
Issuance date Jun. 07, 2016    
Total loan balance $ 70,000    
Secured debt original draw $ 55,000    
Interest rate, stated percentage 8.25%    
Debt instrument, covenant in compliance in compliance    
Interest Expense, debt $ 1,400    
Outstanding loan balance 53,400    
Debt Instrument, Unamortized Discount $ 400    
Maturity date Jan. 01, 2021    
Final payment as percent of original principal 5.50%    
Debt Instrument, Unused Borrowing Capacity, Amount $ 15,000    
Debt Instrument, interest only period interest only payments for the first 18 months    
Accrued interest, noncurrent $ 400    
Accretion of debt balloon payment $ 1,600    
Senior Loans [Member] | Minimum [Member]      
Debt Instrument [Line Items]      
Prepayment fee, percent 1.00%    
Senior Loans [Member] | Maximum [Member]      
Debt Instrument [Line Items]      
Prepayment fee, percent 2.00%    
v3.8.0.1
Share-based Compensation (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]    
Allocated Share-based Compensation Expense $ 8,339 $ 7,315
Stock options    
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]    
Allocated Share-based Compensation Expense 4,559 4,749
RSU, RSA, and PRSU awards [Member]    
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]    
Allocated Share-based Compensation Expense 3,780 2,566
Research and Development Expense [Member]    
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]    
Allocated Share-based Compensation Expense 3,914 3,274
Selling, General and Administrative Expenses [Member]    
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]    
Allocated Share-based Compensation Expense $ 4,425 $ 4,041
v3.8.0.1
Share-based Compensation Share-based compensation textuals (Details) - shares
shares in Millions
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Share-based Compensation [Abstract]    
Options, Grants in Period 1.6 2.2
v3.8.0.1
Share-based Compensation Share-based compensation, valuation (Details)
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Schedule of Share-based Compensation Arrangements Valuation Inputs [Line Items]    
Fair Value Assumptions, Weighted Average Expected Term 5 years 6 months 5 years 7 months
Fair Value Assumptions, Expected Dividend Rate 0.00% 0.00%
Fair Value Assumptions, Risk Free Interest Rate, Minimum 2.25% 1.92%
Fair Value Assumptions, Risk Free Interest Rate, Maximum 2.65% 1.94%
Minimum [Member]    
Schedule of Share-based Compensation Arrangements Valuation Inputs [Line Items]    
Fair Value Assumptions, Weighted Average Volatility Rate 62.60% 71.00%
Maximum [Member]    
Schedule of Share-based Compensation Arrangements Valuation Inputs [Line Items]    
Fair Value Assumptions, Weighted Average Volatility Rate 70.10% 71.70%
v3.8.0.1
Share-based Compensation Share-based compensation, unrecognized (Details)
$ in Thousands
3 Months Ended
Mar. 31, 2018
USD ($)
Stock options  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Compensation Cost Not yet Recognized $ 46,233
Compensation Cost Not yet Recognized, Period for Recognition 2 years 6 months 29 days
RSAs  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Compensation Cost Not yet Recognized $ 3,434
Compensation Cost Not yet Recognized, Period for Recognition 1 year 3 months 29 days
RSUs  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Compensation Cost Not yet Recognized $ 36,667
Compensation Cost Not yet Recognized, Period for Recognition 2 years 8 months 12 days
v3.8.0.1
Stockholders' Equity (Deficit) Public Offering (Details)
$ / shares in Units, $ in Thousands, shares in Millions
3 Months Ended
Mar. 31, 2018
USD ($)
$ / shares
shares
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 | $ / shares $ 12.50
Proceeds from issuance of common stock, net | $ $ 134,875
v3.8.0.1
Stockholders' Equity (Deficit) (Details) - USD ($)
$ / shares in Units, $ in Millions
3 Months Ended
Mar. 31, 2018
Mar. 31, 2017
Dec. 31, 2017
Stockholders' equity (deficit) (textual)      
Outstanding stock options and restricted stock units 14,100,000   13,000,000
Stock options      
Stockholders' equity (deficit) (textual)      
Number of shares of common stock issued as a result of stock option exercises 705,856 74,522  
Stock options weighted average exercise price $ 10.47 $ 7.78  
Net proceeds from stock options exercised $ 7.4 $ 0.6  
Restricted stock units      
Stockholders' equity (deficit) (textual)      
Stock issued during period, shares, restricted stock award, net of forfeitures 410,306 252,305  
Number of RSUs surrendered to pay for minimum withholding taxes 129,465 79,499  
Payments for tax withholding for restricted stock units vested, net $ 2.4 $ 1.7  
v3.8.0.1
Subsequent Event (Details)
$ in Thousands
Mar. 31, 2018
USD ($)
Subsequent Event [Line Items]  
Recognized revenue in the fourth quarter $ 21,900