Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Nov. 04, 2013 | |
Document Information [Line Items] | ' | ' |
Entity Registrant Name | 'HALOZYME THERAPEUTICS INC | ' |
Entity Central Index Key | '0001159036 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 30-Sep-13 | ' |
Amendment Flag | 'false | ' |
Document Fiscal Year Focus | '2013 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Large Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 114,028,596 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (Unaudited) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Current assets: | ' | ' |
Cash and cash equivalents | $17,492,131 | $99,501,264 |
Marketable securities, available-for-sale | 47,818,851 | 0 |
Accounts receivable, net | 24,521,742 | 15,703,087 |
Inventories | 3,846,290 | 2,670,696 |
Prepaid expenses and other assets | 9,139,014 | 12,752,888 |
Total current assets | 102,818,028 | 130,627,935 |
Property and equipment, net | 4,935,928 | 3,700,462 |
Prepaid expenses and other assets | 1,891,170 | 0 |
Restricted cash | 500,000 | 400,000 |
Total Assets | 110,145,126 | 134,728,397 |
Current liabilities: | ' | ' |
Accounts payable | 5,591,763 | 2,271,689 |
Accrued expenses | 20,624,501 | 7,783,447 |
Deferred revenue, current portion | 7,437,433 | 8,891,017 |
Current portion of long-term debt, net | 5,970,119 | 0 |
Total current liabilities | 39,623,816 | 18,946,153 |
Deferred revenue, net of current portion | 45,940,511 | 34,954,966 |
Long-term debt, net | 23,781,955 | 29,661,680 |
Lease financing obligation | 2,550,000 | 1,450,000 |
Deferred rent, net of current portion | 813,689 | 861,879 |
Other long-term liability | 921,460 | 0 |
Commitments and contingencies (Note 8) | ' | ' |
Stockholders' (deficit) equity: | ' | ' |
Preferred stock - $0.001 par value; 20,000,000 shares authorized; no shares issued and outstanding | 0 | 0 |
Common stock - $0.001 par value; 200,000,000 shares authorized; 113,986,739 shares issued and outstanding at September 30, 2013 and 150,000,000 shares authorized; 112,709,174 shares issued and outstanding at December 31, 2012 | 113,987 | 112,709 |
Additional paid-in capital | 356,449,825 | 347,314,658 |
Accumulated other comprehensive income | 15,779 | 0 |
Accumulated deficit | -360,065,896 | -298,573,648 |
Total stockholders' (deficit) equity | -3,486,305 | 48,853,719 |
Total Liabilities and Stockholders' (Deficit) Equity | $110,145,126 | $134,728,397 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Statement of Financial Position [Abstract] | ' | ' |
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 200,000,000 | 150,000,000 |
Common stock, shares issued | 113,986,739 | 112,709,174 |
Common stock, shares outstanding | 113,986,739 | 112,709,174 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (Unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Revenues: | ' | ' | ' | ' |
Product sales, net | $10,024,902 | $715,354 | $14,633,349 | $1,427,707 |
Revenues under collaborative agreements | 5,988,262 | 4,618,969 | 27,667,165 | 19,103,970 |
Total revenues | 16,013,164 | 5,334,323 | 42,300,514 | 20,531,677 |
Operating expenses: | ' | ' | ' | ' |
Cost of product sales | 682,713 | 226,635 | 2,705,633 | 440,516 |
Research and development | 25,689,189 | 19,503,491 | 75,714,381 | 51,476,329 |
Selling, general and administrative | 8,135,118 | 5,634,034 | 22,990,777 | 17,833,165 |
Total operating expenses | 34,507,020 | 25,364,160 | 101,410,791 | 69,750,010 |
Operating loss | -18,493,856 | -20,029,837 | -59,110,277 | -49,218,333 |
Investment and other income | 51,424 | 23,991 | 164,544 | 72,187 |
Interest expense | -849,936 | 0 | -2,546,515 | 0 |
Net loss | ($19,292,368) | ($20,005,846) | ($61,492,248) | ($49,146,146) |
Basic and diluted net loss per share | ($0.17) | ($0.18) | ($0.55) | ($0.44) |
Shares used in computing basic and diluted net loss per share | 112,765,155 | 112,305,002 | 112,554,447 | 110,658,757 |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Statement of Comprehensive Income [Abstract] | ' | ' | ' | ' |
Net loss | ($19,292,368) | ($20,005,846) | ($61,492,248) | ($49,146,146) |
Other comprehensive income (loss): | ' | ' | ' | ' |
Unrealized gain on marketable securities | 55,088 | 0 | 15,779 | 0 |
Comprehensive Loss | ($19,237,280) | ($20,005,846) | ($61,476,469) | ($49,146,146) |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements of Cash Flows (Unaudited) (USD $) | 9 Months Ended | |
Sep. 30, 2013 | Sep. 30, 2012 | |
Operating activities: | ' | ' |
Net loss | ($61,492,248) | ($49,146,146) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Share-based compensation | 7,139,998 | 6,362,372 |
Depreciation and amortization | 893,477 | 796,163 |
Non-cash interest expense | 1,036,502 | 0 |
Amortization of premiums on investments, net of accretion of discounts | 816,196 | 0 |
Gain on disposals of equipment | 0 | -6,610 |
Changes in operating assets and liabilities: | ' | ' |
Accounts receivable, net | -8,818,655 | -2,201,808 |
Inventories | -1,175,594 | -1,618,800 |
Prepaid expenses and other assets | 2,017,859 | -3,021,100 |
Restricted cash | -100,000 | 0 |
Accounts payable and accrued expenses | 16,070,721 | -2,106,754 |
Deferred rent | -39,742 | 62,385 |
Deferred revenue | 9,531,961 | 3,469,392 |
Net cash used in operating activities | -34,119,525 | -47,410,906 |
Investing activities: | ' | ' |
Purchases of marketable securities | 48,946,616 | 0 |
Purchases of property and equipment | -939,439 | -873,165 |
Net cash used in investing activities | -49,886,055 | -873,165 |
Financing activities: | ' | ' |
Proceeds from issuance of common stock, net | 0 | 81,476,845 |
Proceeds from issuance of common stock under equity incentive plans, net | 1,996,447 | 1,596,590 |
Net cash provided by financing activities | 1,996,447 | 83,073,435 |
Net (decrease) increase in cash and cash equivalents | -82,009,133 | 34,789,364 |
Cash and cash equivalents at beginning of period | 99,501,264 | 52,825,527 |
Cash and cash equivalents at end of period | 17,492,131 | 87,614,891 |
Supplemental disclosure of cash flow information: | ' | ' |
Interest and fees paid | 1,529,438 | 0 |
Supplemental disclosure of non-cash investing and financing activities: | ' | ' |
Capitalized property and liability associated with a build-to-suit lease arrangement | 1,100,000 | 0 |
Property and equipment purchases in accounts payable and accrued expenses | $89,504 | $508,990 |
Organization_and_Business
Organization and Business | 9 Months Ended |
Sep. 30, 2013 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' |
Organization and Business | ' |
Organization and Business | |
Halozyme Therapeutics, Inc. is a science-driven, biopharmaceutical company committed to making molecules into medicines for patients in need. Our research focuses primarily on human enzymes that alter the extracellular matrix. 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 can be used to facilitate the delivery of injected drugs and fluids, thus enhancing the efficacy and the convenience of other drugs or to alter abnormal tissue structures for clinical benefit. We have chosen to exploit our technology and expertise in a balanced way to modulate both risk and spend by: (1) developing our own proprietary products in therapeutic areas with significant unmet medical needs, such as diabetes, oncology and dermatology, and (2) licensing our technology to biopharmaceutical companies to collaboratively develop products which combine our technology with the collaborators' proprietary compounds. | |
The majority of the product candidates in our current pipeline are based on rHuPH20, a patented human recombinant hyaluronidase enzyme. rHuPH20 temporarily breaks down hyaluronic acid - a naturally occurring substance that is a major component of the extracellular matrix in tissues throughout the body such as skin and cartilage. We have one proprietary commercial product, Hylenex® recombinant. Our proprietary pipeline consists of multiple clinical stage products in diabetes, oncology and dermatology. We currently have collaborations with F. Hoffmann-La Roche, Ltd. and Hoffmann-La Roche, Inc. (“Roche”), Pfizer Inc. (“Pfizer”), Baxter Healthcare Corporation (“Baxter”), ViroPharma Incorporated (“ViroPharma”), and Intrexon Corporation (“Intrexon”), with two approved products in Europe, one product candidate which has been submitted for regulatory approval in the U.S. and one product candidate which has been submitted for regulatory approval in Europe as well as several others at various stages of development. | |
We were founded in 1998 and reincorporated from the State of Nevada to the State of Delaware in November 2007. 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 our wholly-owned subsidiary, Halozyme, Inc. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 9 Months Ended | ||||||||||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||||||||||
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, 2012, filed with the SEC on March 1, 2013. 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. Operating results for interim periods are not necessarily indicative of the operating results for an entire fiscal year. | |||||||||||||||||||||||||
The condensed consolidated financial statements include the accounts of Halozyme Therapeutics, Inc. and our wholly owned subsidiary, Halozyme, Inc. All intercompany accounts and transactions have been eliminated. | |||||||||||||||||||||||||
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. | |||||||||||||||||||||||||
Adoption of Recent Accounting Pronouncement | |||||||||||||||||||||||||
Effective January 1, 2013, we adopted Financial Accounting Standards Board’s (“FASB”) Accounting Standards Update (“ASU”) No. 2013-02, Comprehensive Income (Topic 220): Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income. The provisions of ASU No. 2013-02 require companies to present reclassifications out of accumulated other comprehensive income and other amounts of other comprehensive income separately by each component of other comprehensive income on the face of the financial statements or in the notes. This update is effective prospectively for reporting periods beginning after December 15, 2012. The adoption of ASU No. 2013-02 did not have a material impact on our consolidated financial position or results of operations as the requirements are disclosure only in nature. ASU No. 2013-02 did not impact our disclosures as there were no reclassifications in any periods reported. | |||||||||||||||||||||||||
Pending Adoption of Recent Accounting Pronouncement | |||||||||||||||||||||||||
In July 2013, FASB issued ASU No. 2013-11, Income Taxes (Topic 740), Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists. The provisions of ASU No. 2013-11 require entities to present unrecognized tax benefits as a decrease in a net operating loss, similar tax loss or tax credit carryforward if certain criteria are met. The determination of whether a deferred tax asset is available is based on the unrecognized tax benefit and the deferred tax asset that exists at the reporting date and presumes disallowance of the tax position at the reporting date. The guidance will eliminate the diversity in practice in the presentation of unrecognized tax benefits but will not alter the way in which entities assess deferred tax assets for realizability. The amendments are effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2014. The amendments should be applied prospectively to unrecognized tax benefits that exist at the effective date. Early adoption is permitted. The adoption of ASU No. 2013-11 will not have a material impact on our consolidated financial position or results of operations. | |||||||||||||||||||||||||
Cash Equivalents and Marketable Securities | |||||||||||||||||||||||||
Cash equivalents consist of highly liquid investments, readily convertible to cash, that mature within ninety days or less from date of purchase. Our cash equivalents consist of money market funds. | |||||||||||||||||||||||||
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 loss and included as a separate component of stockholders' (deficit) equity. 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 income. We use the specific 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 income in the consolidated statement of operations. There were no realized gains or losses during the reporting periods. | |||||||||||||||||||||||||
Restricted Cash | |||||||||||||||||||||||||
Under the terms of the leases of our facilities, we are required to maintain letters of credit as security deposits during the term of such leases. At September 30, 2013 and December 31, 2012, restricted cash of $500,000 and $400,000, respectively, was pledged as collateral for the letters of credit. To conform to the current period presentation, we have reclassified $400,000 from cash and cash equivalents to restricted cash in the consolidated balance sheet at December 31, 2012. | |||||||||||||||||||||||||
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, marketable securities, accounts receivable, prepaid expenses, 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, 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. Further, based on the borrowing rates currently available to us 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 corporate debt securities, commercial paper and certificates of deposit and were measured at fair value using 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 service. 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. | |||||||||||||||||||||||||
The following table summarizes, by major security type, our cash equivalents and marketable securities that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy: | |||||||||||||||||||||||||
September 30, 2013 | 31-Dec-12 | ||||||||||||||||||||||||
Level 1 | Level 2 | Total estimated fair value | Level 1 | Level 2 | Total estimated fair value | ||||||||||||||||||||
Cash equivalents: | |||||||||||||||||||||||||
Money market funds | $ | 11,853,450 | $ | — | $ | 11,853,450 | $ | 98,024,269 | $ | — | $ | 98,024,269 | |||||||||||||
Available-for-sale marketable | |||||||||||||||||||||||||
securities: | |||||||||||||||||||||||||
Corporate debt securities | — | 38,826,192 | 38,826,192 | — | — | — | |||||||||||||||||||
Commercial paper | — | 5,992,659 | 5,992,659 | — | — | — | |||||||||||||||||||
Certificate of deposit | — | 3,000,000 | 3,000,000 | — | — | — | |||||||||||||||||||
$ | 11,853,450 | $ | 47,818,851 | $ | 59,672,301 | $ | 98,024,269 | $ | — | $ | 98,024,269 | ||||||||||||||
There were no transfers between Level 1 and Level 2 of the fair value hierarchy in the nine months ended September 30, 2013 and 2012. We have no instruments that are classified within Level 3 as of September 30, 2013 and December 31, 2012. | |||||||||||||||||||||||||
Inventories | |||||||||||||||||||||||||
Inventories are stated at lower of cost or market. Cost is determined on a first-in, first-out basis. Inventories are reviewed periodically for potential excess, dated or obsolete status. Management evaluates 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 expense costs relating to the purchase and production of pre-approval inventories for which the sole use is pre-approval products as research and development expense in the period incurred until such time as we believe future commercialization is probable and future economic benefit is expected to be realized. Inventories used in clinical trials are expensed at the time the inventories are packaged for the clinical trials. Prior to receiving approval from the U.S. Food and Drug Administration ("FDA") or comparable regulatory agencies in foreign countries, costs related to purchases of bulk rHuPH20 enzyme ("active pharmaceutical ingredient" or "API") and raw materials and the manufacturing of the product candidates are recorded as research and development expense. All direct manufacturing costs incurred after approval are capitalized as inventory. | |||||||||||||||||||||||||
As of September 30, 2013 and December 31, 2012, inventories consisted of $2.5 million and $2.7 million of Hylenex recombinant inventory, respectively, and $1.3 million and zero of API used in the manufacture of Herceptin SC, respectively. Roche received European marketing approval for its collaboration product, Herceptin® SC, in August 2013 and Baxter for its collaboration product, HyQvia, in May 2013. As such, direct manufacturing costs of API for Herceptin SC and HyQvia incurred after the receipt of the European marketing approvals are being capitalized as inventory. | |||||||||||||||||||||||||
Revenue Recognition | |||||||||||||||||||||||||
We generate revenues from product sales and collaborative agreements. Payments received under collaborative agreements may include nonrefundable fees at the inception of the agreements, license fees, milestone payments for specific achievements designated in the collaborative agreements, reimbursements of research and development services and supply of rHuPH20 API, and/or royalties on sales of products resulting from collaborative arrangements. | |||||||||||||||||||||||||
We recognize revenues in accordance with the authoritative guidance for revenue recognition. We recognize revenue when all of the following criteria are 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. | |||||||||||||||||||||||||
Product Sales, Net | |||||||||||||||||||||||||
Hylenex Recombinant | |||||||||||||||||||||||||
In December 2011, we reintroduced Hylenex recombinant to the market and began promoting Hylenex recombinant through our sales force. We sell Hylenex recombinant in the United States to wholesale pharmaceutical distributors, who sell the product to hospitals and other end-user customers. The wholesale distributors take title to the product, bear the risk of loss of ownership and have economic substance to the inventory. Further, we have no significant obligations for future performance to generate pull-through sales; however, we allow the wholesale distributors to return product that is damaged or received in error. In addition, we allow for product to be returned beginning six months prior to and ending twelve months following product expiration. | |||||||||||||||||||||||||
Given our limited history of selling Hylenex recombinant and the lengthy return period, we currently cannot reliably estimate expected returns and chargebacks of Hylenex recombinant at the time the product is received by the wholesale distributors. Therefore, we do not recognize revenue upon delivery of Hylenex recombinant to the wholesale distributor until the point at which we can reliably estimate expected product returns and chargebacks from the wholesale distributors. Shipments of Hylenex recombinant are recorded as deferred revenue until evidence exists to confirm that pull-through sales to the hospitals or other end-user customers have occurred. We recognize revenue when the product is sold through from the distributors to the distributors’ customers. In addition, the costs of manufacturing Hylenex recombinant associated with the deferred revenue are recorded as deferred costs, which are included in inventory, until such time as the related deferred revenue is recognized. We estimate sell-through revenue and certain sales allowances based on analysis of third-party information including information obtained from certain distributors with respect to their inventory levels and sell-through to the distributors’ customers. At the time we can reliably estimate product returns and chargebacks from the wholesale distributors, we will record a one-time increase in net product sales revenue related to the recognition of product sales revenue previously deferred. | |||||||||||||||||||||||||
We recognize product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of our agreements with wholesale distributors and hospitals. We must make significant judgments in determining these allowances. If actual results differ from our estimates, we will be required to make adjustments to these allowances in the future, which could have an effect on product sales revenue in the period of adjustment. | |||||||||||||||||||||||||
Our product sales allowances include: | |||||||||||||||||||||||||
Distribution Fees. The distribution fees, based on contractually determined rates, arise from contractual agreements we have with certain wholesale distributors for distribution services they provide with respect to Hylenex recombinant. At the time the sale is made to the respective wholesale distributors, we record an allowance for distribution fees by reducing our accounts receivable and deferred revenue associated with such product sales. | |||||||||||||||||||||||||
Prompt Payment Discounts. We offer cash discounts to certain wholesale distributors as an incentive to meet certain payment terms. We expect our customers will take advantage of this discount; therefore, at the time the sale is made to the respective wholesale distributors, we accrue the entire prompt payment discount, based on the gross amount of each invoice, by reducing our accounts receivable and deferred revenue associated with such product sales. | |||||||||||||||||||||||||
Other Discounts and Fees. We provide discounts to end-user members of certain group purchasing organizations (“GPO”) under collective purchasing contracts between us and the GPOs. We also provide discounts to certain hospitals, who are members of the GPOs, with which we do not have contracts. The end-user members purchase products from the wholesale distributors at a contracted discounted price, and the wholesale distributors then charge back to us the difference between the current retail price and the price the end-users paid for the product. Given our lack of historical sales data, we recognize these chargebacks in the same period the related product sales revenue is recognized and reduce our accounts receivable accordingly. We incur GPO fees for these transactions which are also recorded in the same period the related product sales revenue is recognized and are included in accrued expenses. | |||||||||||||||||||||||||
Product Returns. The product returns reserve is based on management’s best estimate of the product sales recognized as revenue during the period that are anticipated to be returned. The product returns reserve is recorded as a reduction of product sales revenue in the same period the related product sales revenue is recognized and is included in accrued expenses. | |||||||||||||||||||||||||
rHuPH20 API | |||||||||||||||||||||||||
Subsequent to receiving approval from the FDA or comparable regulatory agencies in foreign countries, sales of API for collaboration commercial products are recognized as product sales when the API has met all the specifications required for the customer's acceptance and title and risk of loss have transferred to the customer. Following the receipts of European marketing approvals of Roche's Herceptin SC product in August 2013 and Baxter's HyQvia product in May 2013, revenue from the sales of API for these collaboration products will be recognized as product sales. For the three and nine months ended September 30, 2013, we recognized product sales of API in the amounts of $7.9 million for Herceptin SC and zero and $1.1 million, respectively, for HyQvia. | |||||||||||||||||||||||||
Revenues under Collaborative Agreements | |||||||||||||||||||||||||
We have license and collaboration agreements under which the collaborators obtained worldwide rights for the use of our proprietary rHuPH20 enzyme in the development and commercialization of the collaborators’ biologic compounds. The collaborative agreements contain multiple elements including nonrefundable payments at the inception of the arrangement, license fees, exclusivity fees, payments based on achievement of specified milestones designated in the collaborative agreements, annual maintenance fees, reimbursements of research and development services, payments for supply of rHuPH20 API for the collaborator and/or royalties on sales of products resulting from collaborative agreements. We analyze each element of our collaborative agreements and consider a variety of factors in determining the appropriate method of revenue recognition of each element. | |||||||||||||||||||||||||
In order to account for the multiple-element arrangements, we identify the deliverables included within the agreement and evaluate which deliverables represent units of accounting. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. The deliverables under our collaborative agreements include (i) the license to our rHuPH20 technology, (ii) at the collaborator’s request, research and development services which are reimbursed at contractually determined rates, and (iii) at the collaborator’s request, supply of rHuPH20 API which is reimbursed at our cost plus a margin. A delivered item is considered a separate unit of accounting when the delivered item has value to the collaborator on a standalone basis based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research capabilities of the collaborator and the availability of research expertise in this field in the general marketplace. | |||||||||||||||||||||||||
Arrangement consideration is allocated at the inception of the agreement to all identified units of accounting based on their relative selling price. The relative selling price for each deliverable is determined using vendor specific objective evidence (“VSOE”) of selling price or third-party evidence of selling price if VSOE does not exist. If neither VSOE nor third-party evidence of selling price exists, we use our best estimate of the selling price for the deliverable. The amount of allocable arrangement consideration is limited to amounts that are not contingent upon the delivery of additional items or meeting other specified performance conditions. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. Changes in the allocation of the sales price between delivered and undelivered elements can impact revenue recognition but do not change the total revenue recognized under any agreement. | |||||||||||||||||||||||||
Nonrefundable upfront license fee payments are recognized upon delivery of the license if facts and circumstances dictate that the license has standalone value from the undelivered items, which generally include research and development services and the manufacture of rHuPH20 API, the relative selling price allocation of the license is equal to or exceeds the upfront license fee, persuasive evidence of an arrangement exists, our price to the collaborator is fixed or determinable and collectibility is reasonably assured. Upfront license fee payments are deferred if facts and circumstances dictate that the license does not have standalone value. The determination of the length of the period over which to defer revenue is subject to judgment and estimation and can have an impact on the amount of revenue recognized in a given period. | |||||||||||||||||||||||||
Prior to the adoption of ASU No. 2009-13, Multiple-Deliverable Revenue Arrangements, on January 1, 2011, in order for a delivered item to be accounted for separately from other deliverables in a multiple-element arrangement, the following three criteria had to be met: (i) the delivered item had standalone value to the customer, (ii) there was objective and reliable evidence of fair value of the undelivered items and (iii) if the arrangement included a general right of return relative to the delivered item, delivery or performance of the undelivered items was considered probable and substantially in the control of the vendor. For the collaborative agreements entered into prior to January 1, 2011, there was no objective and reliable evidence of fair value of the undelivered items. Thus, the delivered licenses did not meet all of the required criteria to be accounted for separately from undelivered items. Therefore, we recognize revenue on nonrefundable upfront payments and license fees from these collaborative agreements over the period of significant involvement under the related agreements. | |||||||||||||||||||||||||
The terms of our collaborative agreements provide for milestone payments upon achievement of certain development and regulatory events and/or specified sales volumes of commercialized products by the collaborator. We account for milestone payments in accordance with the provisions of ASU No. 2010-17, Revenue Recognition - Milestone Method. We recognize consideration that is contingent upon the achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone is substantive in its entirety. A milestone is considered substantive when it meets all of the following criteria: | |||||||||||||||||||||||||
1 | The consideration is commensurate with either the entity’s performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, | ||||||||||||||||||||||||
2 | The consideration relates solely to past performance, and | ||||||||||||||||||||||||
3 | The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. | ||||||||||||||||||||||||
A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity’s performance or on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to the vendor. | |||||||||||||||||||||||||
Reimbursements of research and development services are recognized as revenue during the period in which the services are performed as long as there is persuasive evidence of an arrangement, the fee is fixed or determinable and collection of the related receivable is reasonably assured. Revenue from the manufacture of rHuPH20 API is recognized when the API has met all specifications required for the collaborator's acceptance and title and risk of loss have transferred to the collaborator. We do not directly control when any collaborator will request research and development services or supply of rHuPH20 API; therefore, we cannot predict when we will recognize revenues in connection with research and development services and supply of rHuPH20 API. | |||||||||||||||||||||||||
Royalty revenue from sales of collaboration products by our collaborators will be recognized when received, which is generally in the quarter following the quarter in which the corresponding sales occur. | |||||||||||||||||||||||||
The collaborative agreements typically provide the collaborators the right to terminate such agreement in whole or on a product-by-product or target-by-target basis at any time upon 30 to 90 days prior written notice to us. There are no performance, cancellation, termination or refund provisions in any of our collaborative agreements that contain material financial consequences to us. | |||||||||||||||||||||||||
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. Cost of product sales also consists of the write-down of excess, dated and obsolete inventories and the write-off of any inventories that do not meet certain product specifications. Prior to European marketing approvals of Herceptin SC and HyQvia, all costs related to the manufacturing of API for these products were charged to research and development expenses in the periods such costs were incurred. Therefore, there was minimal cost recognized for the product sales of API for these collaboration products in the three and nine months ended September 30, 2013. Of the Herceptin SC API on hand as of September 30, 2013, $2.6 million in manufacturing costs have been previously recorded as 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 operations as incurred when these expenditures relate to our research and development efforts and have no alternative future uses. Costs related to purchases of API and the manufacturing of a collaboration product incurred after receiving approval from the FDA or comparable regulatory agencies in foreign countries for such product are capitalized as inventory. The manufacturing costs of API for Herceptin SC and HyQvia incurred after the receipt of the European marketing approvals are capitalized as inventory. | |||||||||||||||||||||||||
In accordance with certain research and development agreements, we are obligated to make certain upfront payments upon execution of the agreement. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts will be recognized as an 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 or product candidates are expensed as incurred when there is uncertainty in receiving future economic benefits from the licensed technology or product candidates. We consider the future economic benefits from the licensed technology or product candidates to be uncertain until such licensed technology or product candidates are approved for marketing by the regulatory bodies such as the FDA or when other significant risk factors are abated. Management has viewed future economic benefits for all of our licensed technology or product candidates to be uncertain and has expensed these amounts as incurred. | |||||||||||||||||||||||||
Clinical Trial Expenses | |||||||||||||||||||||||||
Payments in connection with our clinical trials are often made under contracts with multiple contract research organizations that conduct and manage clinical trials on our behalf. 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-material basis. Payments under these contracts depend 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 contracted amounts are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), we modify our accruals accordingly on a prospective basis. Revisions in the scope of a contract are charged to expense in the period in which the facts that give rise to the revision become reasonably certain. Historically, we have had no material changes in clinical trial expense accruals that would have had a material impact on our consolidated results of operations or financial position. | |||||||||||||||||||||||||
Share-Based Compensation | |||||||||||||||||||||||||
Total share-based compensation expense related to all of our share-based awards was allocated as follows: | |||||||||||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||||||||||
September 30, | September 30, | ||||||||||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||||||||||
Research and development | $ | 1,089,249 | $ | 913,946 | $ | 3,351,629 | $ | 3,279,940 | |||||||||||||||||
Selling, general and administrative | 1,214,413 | 1,008,447 | 3,788,369 | 3,082,432 | |||||||||||||||||||||
Share-based compensation expense | $ | 2,303,662 | $ | 1,922,393 | $ | 7,139,998 | $ | 6,362,372 | |||||||||||||||||
Net share-based compensation expense, per basic and diluted share | $ | 0.02 | $ | 0.02 | $ | 0.06 | $ | 0.06 | |||||||||||||||||
Share-based compensation expense from: | |||||||||||||||||||||||||
Stock options | $ | 1,284,364 | $ | 1,164,973 | $ | 4,068,793 | $ | 3,491,220 | |||||||||||||||||
Restricted stock awards and restricted stock units | 1,019,298 | 757,420 | 3,071,205 | 2,871,152 | |||||||||||||||||||||
$ | 2,303,662 | $ | 1,922,393 | $ | 7,139,998 | $ | 6,362,372 | ||||||||||||||||||
Since we have a net operating loss carryforward as of September 30, 2013, no excess tax benefits for the tax deductions related to share-based awards were recognized in the interim unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2013. | |||||||||||||||||||||||||
As of September 30, 2013, total unrecognized estimated compensation cost related to non-vested stock options and non-vested restricted stock awards and restricted stock units granted prior to that date was approximately $10.4 million and $7.8 million, respectively, which is expected to be recognized over a weighted-average period of approximately 2.7 years and 2.9 years, respectively. | |||||||||||||||||||||||||
Net Loss Per Share | |||||||||||||||||||||||||
Basic net loss per common share is computed by dividing loss for the period by the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents. Stock options, unvested restricted stock awards (“RSAs”) and unvested restricted stock units ("RSUs") are considered common stock equivalents and are only included in the calculation of diluted earnings per common share when their effect is dilutive. Because of our net loss, outstanding stock options, outstanding RSUs and unvested RSAs totaling approximately 8.6 million and 7.3 million were excluded from the calculation of diluted net loss per common share for the three and nine months ended September 30, 2013 and 2012, respectively, because their effect is 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 that can be used to facilitate the delivery of injected drugs and fluids, thus enhancing the efficacy and the convenience of other drugs or to alter abnormal tissue structures for clinical benefit. This segment also includes revenues and expenses related to (i) research and development and API 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. |
Marketable_Securities_Notes
Marketable Securities (Notes) | 9 Months Ended | |||||||||||||||||
Sep. 30, 2013 | ||||||||||||||||||
Marketable Securities [Abstract] | ' | |||||||||||||||||
Marketable securities disclosure | ' | |||||||||||||||||
Marketable Securities | ||||||||||||||||||
Available-for-sale marketable securities consist of the following: | ||||||||||||||||||
September 30, 2013 | ||||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||||
Corporate debt securities | $ | 38,810,413 | $ | 18,279 | $ | (2,500 | ) | $ | 38,826,192 | |||||||||
Commercial paper | 5,992,659 | — | — | 5,992,659 | ||||||||||||||
Certificate of deposit | 3,000,000 | — | — | 3,000,000 | ||||||||||||||
$ | 47,803,072 | $ | 18,279 | $ | (2,500 | ) | $ | 47,818,851 | ||||||||||
As of September 30, 2013, $47.8 million of available-for-sale marketable securities are scheduled to mature within the next 12 months. There were no securities sold during the nine months ended September 30, 2013. None of these investments have been in a continuous unrealized loss position for more than twelve months as of September 30, 2013. |
Collaborative_Agreements_Notes
Collaborative Agreements (Notes) | 9 Months Ended |
Sep. 30, 2013 | |
Deferred Revenue Disclosure [Abstract] | ' |
Collaborative Agreements | ' |
Collaborative Agreements | |
Roche Collaboration | |
In December 2006, we and Roche entered into a license and collaborative agreement under which Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and up to thirteen Roche target compounds (the “Roche Collaboration”). As of September 30, 2013, Roche has elected a total of five exclusive targets and retains the option to develop and commercialize rHuPH20 with three additional targets, provided that Roche continues to pay annual maintenance fees to us. As of September 30, 2013, we have received $71.75 million from Roche, including the $20.0 million upfront license fee payment for the application of rHuPH20 to the initial three Roche exclusive targets, $20.75 million in connection with Roche's election of two additional exclusive targets and annual license maintenance fees for the right to designate the remaining targets as exclusive targets, $13.0 million in clinical development milestone payments and $8.0 million in regulatory milestone payments. | |
In August 2013, Roche received European marketing approval for its collaboration product, Herceptin SC, for the treatment of patients with HER2-positive breast cancer and launched Herceptin SC in the European Union (EU) which triggered a $10.0 million payment to us for the achievement of the first commercial sale pursuant to the terms of the Roche Collaboration. We determined this payment to be a sales-based payment. Due to our continuing involvement obligations, revenue from the $10.0 million sales-based payment was deferred and is being recognized over the remaining term of the Roche Collaboration. | |
Roche assumes all development, manufacturing, clinical, regulatory, sales and marketing costs under the Roche Collaboration, while we are responsible for the supply of rHuPH20 API. We are entitled to receive reimbursements for providing research and development services and rHuPH20 API to Roche at its request. | |
Under the terms of the Roche Collaboration, Roche will pay us a royalty on each product commercialized under the agreement consisting of a mid-single digit percent of the net sales of such product. Unless terminated earlier in accordance with its terms, the Roche Collaboration continues in effect until the expiration of Roche's obligation to pay royalties. Roche has the obligation to pay royalties with respect to each product in each country, during the period equal to the longer of: (a) the duration of any valid claim of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. Pursuant to the terms of the Roche Collaboration, we scaled up the production of rHuPH20 API and identified a second source manufacturer that would help meet anticipated production obligations arising from the Roche Collaboration. | |
Due to our continuing involvement obligations (for example, support activities associated with rHuPH20), revenues from the upfront payment, exclusive designation fees, annual license maintenance fees and sales-based payment ("Roche Deferred Revenues") were deferred and are being recognized over the term of the Roche Collaboration. In addition, we received prepayments associated with the manufacture of rHuPH20 API as requested by Roche. The manufacturing prepayments have been deferred and are being recognized as revenue as API is delivered to Roche. | |
For the three months ended September 30, 2013 and 2012, we recognized amortization of the Roche Deferred Revenues as revenues under collaborative agreements totaling approximately $575,000 and $503,000, respectively. For the nine months ended September 30, 2013 and 2012, we recognized amortization of the Roche Deferred Revenues and manufacturing prepayments totaling approximately $3.9 million and $1.5 million, respectively. The total of Roche Deferred Revenues and manufacturing prepayments was approximately $42.0 million and $35.9 million as of September 30, 2013 and December 31, 2012, respectively. | |
We recognized zero and $4.0 million as revenues under collaborative agreements related to the achievement of a regulatory milestone pursuant to the terms of the Roche Collaboration for the three and nine months ended September 30, 2012, respectively. | |
Gammagard Collaboration | |
In September 2007, we entered into a license and collaborative agreement with Baxter, under which Baxter obtained a worldwide, exclusive license to develop and commercialize a product consisting of rHuPH20 combined with a current Baxter product, GAMMAGARD LIQUID™ (the “Gammagard Collaboration”). As of September 30, 2013, we have received $17.0 million under the Gammagard Collaboration, including the $10.0 million upfront license fee payment, a $3.0 million regulatory milestone payment and a $4.0 million sales-based payment. Baxter will pay us a royalty on each product commercialized under the agreement consisting of a mid-single digit percent of the net sales of such product. | |
In May 2013, the European Commission granted Baxter marketing authorization in all EU Member States for the use of HyQvia (solution for subcutaneous use), a combination of GAMMAGARD LIQUID and rHuPH20 in dual vial units, as replacement therapy for adult patients with primary and secondary immunodeficiencies. Baxter launched HyQvia into the first EU country in July 2013 and plans to introduce HyQvia in additional selected EU countries during 2013 and expand the launch to other EU markets in 2014. The achievement of the first commercial sale triggered a $4.0 million payment to us. We determined this payment to be a sales-based payment. Due to our continuing involvement obligations, revenue from the sales-based payment was deferred and is being recognized over the remaining term of the Gammagard Collaboration. | |
The Gammagard Collaboration is applicable to both kit and formulation combinations. Baxter assumes all development, manufacturing, clinical, regulatory, sales and marketing costs under the Gammagard Collaboration, while we are responsible for the supply of rHuPH20 API. We perform research and development activities and supply rHuPH20 API at the request of Baxter, which are reimbursed by Baxter under the terms of the Gammagard Collaboration. In addition, Baxter has certain product development and commercialization obligations in major markets identified in the Gammagard Collaboration. | |
Unless terminated earlier in accordance with its terms, the Gammagard Collaboration continues in effect until the expiration of Baxter's obligation to pay royalties. Baxter has the obligation to pay royalties, with respect to each product in each country, during the period equal to the longer of: (a) the duration of any valid claim of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. | |
Due to our continuing involvement obligations (for example, support activities associated with rHuPH20 enzyme), the upfront and sales-based payments were deferred and are being recognized over the term of the Gammagard Collaboration. We recognized revenue from the upfront and sales-based payments in the amount of approximately $174,000 and $121,000 for the three months ended September 30, 2013 and 2012, respectively. We recognized revenue from the upfront and sales-based payments in the amount of approximately $415,000 and $362,000 for the nine months ended September 30, 2013 and 2012, respectively. Deferred revenue relating to the upfront and sales-based payments under the Gammagard Collaboration was approximately $10.7 million and $7.1 million as of September 30, 2013 and December 31, 2012, respectively. | |
Other Collaborations | |
In December 2012, we and Pfizer entered into a collaboration and license agreement, under which Pfizer has the worldwide license to develop and commercialize products combining rHuPH20 enzyme with Pfizer proprietary biologics directed at six targets, of which three were specified (the “Pfizer Collaboration”). Targets may be selected on an exclusive or non-exclusive basis. In September 2013, Pfizer designated a fourth target on an exclusive basis which resulted in a $1.5 million license fee payment to us. As of September 30, 2013, we have received $11.0 million in upfront and license fee payments for the licenses to four specified exclusive targets and two additional targets which Pfizer has the right to elect in the future upon payment of additional fees. Unless terminated earlier in accordance with its terms, the Pfizer 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. The royalty term of a product developed under the Pfizer Collaboration, with respect to each country, consists of the period equal to the longer of: (a) the duration of any valid claim of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. Pfizer may terminate the agreement prior to expiration for any reason in its entirety or on a target-by-target basis upon 30 days prior written notice to us. Upon any such termination, the license granted to Pfizer (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-up. | |
In May 2011, we and ViroPharma entered into a collaboration and license agreement, under which ViroPharma obtained a worldwide exclusive license for the use of rHuPH20 enzyme in the development and commercialization of a subcutaneous injectable formulation of ViroPharma's commercialized product, Cinryze® (C1 esterase inhibitor [human]) (the “ViroPharma Collaboration”). In addition, the license provides ViroPharma with exclusivity to C1 esterase inhibitor and to the hereditary angioedema indication, along with three additional orphan indications. As of September 30, 2013, we have received $14.0 million from ViroPharma, including the $9.0 million nonrefundable upfront license fee payment and a $3.0 million clinical development milestone payment. We are entitled to receive a royalty on each product commercialized under the agreement consisting of ten percent of the net sales of such product. Unless terminated earlier in accordance with its terms, the ViroPharma 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. The royalty term of a product developed under the ViroPharma Collaboration, with respect to each country, consists of the period equal to the longer of: (a) the duration of any valid claim of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. ViroPharma may terminate the agreement prior to expiration for any reason on a product-by-product basis upon 90 days prior written notice to us. Upon any such termination, the license granted to ViroPharma (in total or with respect to the terminated product, as applicable) will terminate. | |
In June 2011, we and Intrexon entered into a collaboration and license agreement, under which Intrexon obtained a worldwide exclusive license for the use of rHuPH20 enzyme in the development and commercialization of a subcutaneous injectable formulation of Intrexon's recombinant human alpha 1-antitrypsin (rHuA1AT) (the “Intrexon Collaboration”). In addition, the license provides Intrexon with exclusivity for a defined indication (“Exclusive Field”). As of September 30, 2013, we have received $11.0 million from Intrexon, including a nonrefundable upfront license fee payment of $9.0 million. We are entitled to receive a royalty on each product commercialized under the agreement consisting of a percentage of the net sales of such product ranging from mid-single digits up to a low double-digit percentage. Unless terminated earlier in accordance with its terms, the Intrexon 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. The royalty term of a product developed under the Intrexon Collaboration, with respect to each country, consists of the period equal to the longer of: (a) the duration of any valid claim of our patents covering rHuPH20 or other specified patents developed under the collaboration which valid claim covers the product in such country or (b) ten years following the date of the first commercial sale of such product in such country. Intrexon may terminate the agreement prior to expiration for any reason on a product-by-product basis upon 90 days prior written notice to us. Upon any such termination, the license granted to Intrexon (in total or with respect to the terminated product, as applicable) will terminate. Intrexon's chief executive officer, chairman of its board of directors and major shareholder is also a member of our board of directors. | |
We identified the deliverables at the inception of the Pfizer, ViroPharma and Intrexon agreements which are the license, research and development services and API supply. We have determined that the license, research and development services and API supply individually represent separate units of accounting, because each deliverable has standalone value. The estimated selling prices for these units of accounting were determined based on market conditions, the terms of comparable collaborative arrangements for similar technology in the pharmaceutical and biotech industry and entity-specific factors such as the terms of our previous collaborative agreements, our pricing practices and pricing objectives and the nature of the research and development services to be performed for the collaborators. The arrangement consideration was allocated to the deliverables based on the relative selling price method. | |
The amount allocable to the delivered unit or units of accounting is limited to the amount that is not contingent upon the delivery of additional items or meeting other specified performance conditions (the noncontingent amount). As such, we excluded from the allocable arrangement consideration the milestone payments, annual exclusivity fees and royalties regardless of the probability of receipt. Based on the results of our analysis, we allocated $11.0 million in license fees from Pfizer, the $9.0 million upfront license fee from ViroPharma and the $9.0 million upfront license fee from Intrexon to the license fee deliverable under each of the arrangements. We determined that the upfront payments were earned upon the granting of the worldwide, exclusive right to our technology to the collaborators in these arrangements. As a result, we recognized $11.0 million in license fees under the Pfizer Collaboration, the $9.0 million upfront license fee under the ViroPharma Collaboration and the $9.0 million upfront license fee received under the Intrexon Collaboration as revenues under collaborative agreements in the period when such license fees were earned. There were no revenues recognized related to milestone payments under these collaborations for the three and nine months ended September 30, 2013 and 2012. | |
Pfizer, ViroPharma and Intrexon are each solely responsible for the development, manufacturing and marketing of any products resulting from their respective collaborations. We are entitled to receive payments for research and development services and supply of rHuPH20 API to these collaborators if requested by such collaborator. We recognize amounts allocated to research and development services as revenues under collaborative agreements as the related services are performed. We recognize amounts allocated to the sales of API as revenues under collaborative agreements when such API has met all required specifications by the collaborators and the related title and risk of loss and damages have passed to the collaborators. We cannot predict the timing of delivery of research and development services and API as they are at the collaborators' requests. | |
Pursuant to the terms of all of our existing collaborations collectively, we are entitled to receive additional milestone payments for the successful development of the elected targets in the aggregate of up to approximately $68.0 million upon achievement of specified clinical development milestone events and up to approximately $84.0 million upon achievement of specified regulatory milestone events in connection with specified regulatory filings and receipt of marketing approvals. |
Certain_Balance_Sheet_Items_No
Certain Balance Sheet Items (Notes) | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Balance Sheet Related Disclosures [Abstract] | ' | ||||||||
Certain Balance Sheet Items | ' | ||||||||
Certain Balance Sheet Items | |||||||||
Accounts receivable, net consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Accounts receivable from revenues under collaborative agreements | $ | 15,474,799 | $ | 15,058,163 | |||||
Accounts receivable from product sales to collaborators | 7,931,957 | — | |||||||
Accounts receivable from other product sales | 1,512,236 | 823,064 | |||||||
24,918,992 | 15,881,227 | ||||||||
Allowance for distribution fees and discounts | (397,250 | ) | (178,140 | ) | |||||
$ | 24,521,742 | $ | 15,703,087 | ||||||
Inventories consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Raw materials | $ | 1,218,406 | $ | 1,127,061 | |||||
Work-in-process | 1,580,610 | 792,257 | |||||||
Finished goods | 1,047,274 | 751,378 | |||||||
$ | 3,846,290 | $ | 2,670,696 | ||||||
Prepaid expenses and other assets, current consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Prepaid manufacturing expenses | $ | 5,720,041 | $ | 8,152,602 | |||||
Prepaid research and development expenses | 3,121,834 | 2,274,551 | |||||||
Other prepaid expenses | 1,603,147 | 2,250,791 | |||||||
Other assets | 585,162 | 74,944 | |||||||
11,030,184 | 12,752,888 | ||||||||
Less long-term portion | 1,891,170 | — | |||||||
$ | 9,139,014 | $ | 12,752,888 | ||||||
Property and equipment, net consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Research equipment | $ | 6,714,830 | $ | 6,360,004 | |||||
Computer and office equipment | 1,738,669 | 1,432,975 | |||||||
Leasehold improvements | 1,272,151 | 1,138,110 | |||||||
Building (1) | 2,550,000 | 1,450,000 | |||||||
12,275,650 | 10,381,089 | ||||||||
Accumulated depreciation and amortization | (7,339,722 | ) | (6,680,627 | ) | |||||
$ | 4,935,928 | $ | 3,700,462 | ||||||
__________________ | |||||||||
-1 | Represents capitalized building under a build-to-suit lease arrangement where we are considered the owner (for accounting purposes only) during the construction period. | ||||||||
Depreciation and amortization expense totaled approximately $301,000 and $286,000 for the three months ended September 30, 2013 and 2012, respectively, and approximately $893,000 and $796,000 for the nine months ended September 30, 2013 and 2012, respectively. | |||||||||
Accrued expenses consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Accrued outsourced manufacturing expenses | $ | 8,613,848 | $ | 984,192 | |||||
Accrued outsourced research and development expenses | 4,496,267 | 1,239,050 | |||||||
Accrued compensation and payroll taxes | 5,351,965 | 4,053,590 | |||||||
Other accrued expenses | 2,162,421 | 1,506,615 | |||||||
$ | 20,624,501 | $ | 7,783,447 | ||||||
Deferred revenue consists of the following: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Collaborative agreements | $ | 49,481,253 | $ | 43,222,473 | |||||
Product sales | 3,896,691 | 623,510 | |||||||
Total deferred revenue | 53,377,944 | 43,845,983 | |||||||
Less current portion | 7,437,433 | 8,891,017 | |||||||
Deferred revenue, net of current portion | $ | 45,940,511 | $ | 34,954,966 | |||||
Refer to Note 4 for a further discussion of our collaborative agreements and deferred revenue. |
LongTerm_Debt_Notes
Long-Term Debt (Notes) | 9 Months Ended |
Sep. 30, 2013 | |
Debt Disclosure [Abstract] | ' |
Long-term Debt | ' |
Long-Term Debt | |
In December 2012, we entered into a Loan and Security Agreement (the “Loan Agreement”) with Oxford Finance LLC (“Oxford”) and Silicon Valley Bank (“SVB”) (collectively, the “Lenders”) for a $30 million secured single-draw term loan facility with a maturity date, as amended, of January 1, 2017, which was fully drawn on December 28, 2012. The proceeds are to be used for working capital and general business requirements. The term loan bears a fixed interest rate of 7.55% per annum. The monthly repayment schedule includes interest only payments in arrears for the first 12 months followed by equal principal and interest payments for the subsequent 36 months. The term loan requires a final payment of $2.55 million which is due when the term loan becomes due or upon the prepayment of the facility. We have the option to prepay the outstanding balance of the term loan in full, subject to a prepayment fee of 1% to 3% depending upon when the prepayment occurs. | |
In connection with the term loan, the debt offering costs have been recorded as a debt discount on our condensed consolidated balance sheet which together with the final $2.55 million payment and fixed interest rate payments will be amortized to interest expense throughout the life of the term loan using the effective interest rate method. As of September 30, 2013, accrued interest expense associated with this final payment was approximately $921,000 and classified as other long-term liability on the condensed consolidated balance sheet. | |
The term loan is secured by substantially all of the assets of the Company and Halozyme, Inc., except that the collateral does not include any intellectual property (including licensing, collaboration and similar agreements relating thereto), and certain other excluded assets. The Loan Agreement contains customary representations, warranties and covenants by us, as well as customary events of default and our indemnification obligations. One of the events of default is 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; or a material impairment in the perfection or priority of lender's lien in the collateral or in the value of such collateral. As of September 30, 2013, we believe we were in compliance with all material covenants under the Loan Agreement and there was no material adverse change. | |
Interest expense, including amortization of the debt discount, related to the long-term debt for the three and nine months ended September 30, 2013 was approximately $850,000 and $2.5 million, respectively. |
Stockholders_Deficit_Equity
Stockholders' (Deficit) Equity | 9 Months Ended |
Sep. 30, 2013 | |
Equity [Abstract] | ' |
Stockholders' (Deficit) Equity | ' |
Stockholders’ (Deficit) Equity | |
During the nine months ended September 30, 2013 and 2012, we issued an aggregate of 726,538 and 426,277 shares of common stock, respectively, in connection with the exercises of stock options at a weighted average exercise price of $3.26 and $4.56 per share, respectively, for net proceeds of approximately $2.4 million and $1.9 million, respectively. In addition, for the nine months ended September 30, 2013 and 2012, we issued 85,782 and 81,070 shares of common stock, respectively, upon vesting of certain RSUs. The RSU holders surrendered 58,061 and 46,930 RSUs, respectively, to pay for minimum withholding taxes totaling approximately $374,000 and $347,000, respectively. Stock options and unvested RSUs totaling approximately 7.9 million and 7.1 million shares of our common stock were outstanding as of September 30, 2013 and December 31, 2012, respectively. In addition, we issued 465,245 and 375,908 shares of common stock in connection with the grants of RSAs during the nine months ended September 30, 2013 and 2012, respectively. | |
In May 2013, our stockholders approved an amendment to our Certificate of Incorporation to increase our authorized number of shares of common stock from 150 million shares to 200 million shares. The stockholders also approved the Amended and Restated 2011 Stock Plan which provides for the grant of up to an additional 6.5 million shares of common stock. | |
In February 2012, we completed an underwritten public offering and issued 7,820,000 shares of common stock, including 1,020,000 shares sold pursuant to the full exercise of an over-allotment option granted to the underwriter. All of the shares were offered at a public offering price of $10.61 per share, generating approximately $81.5 million in net proceeds. Of the 7,820,000 shares of common stock sold, Randal J. Kirk, a member of our board of directors, through his affiliates, purchased 1,360,000 shares of common stock in this offering at the public offering price of $10.61 per share for a total of approximately $14.4 million. |
Commitments_and_Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2013 | |
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. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | ||||||||||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||||||||||
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, 2012, filed with the SEC on March 1, 2013. 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. Operating results for interim periods are not necessarily indicative of the operating results for an entire fiscal year. | |||||||||||||||||||||||||
The condensed consolidated financial statements include the accounts of Halozyme Therapeutics, Inc. and our wholly owned subsidiary, Halozyme, Inc. All intercompany accounts and transactions have been eliminated. | |||||||||||||||||||||||||
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. | |||||||||||||||||||||||||
Adoption of Recent Accounting Pronouncements | ' | ||||||||||||||||||||||||
Adoption of Recent Accounting Pronouncement | |||||||||||||||||||||||||
Effective January 1, 2013, we adopted Financial Accounting Standards Board’s (“FASB”) Accounting Standards Update (“ASU”) No. 2013-02, Comprehensive Income (Topic 220): Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income. The provisions of ASU No. 2013-02 require companies to present reclassifications out of accumulated other comprehensive income and other amounts of other comprehensive income separately by each component of other comprehensive income on the face of the financial statements or in the notes. This update is effective prospectively for reporting periods beginning after December 15, 2012. The adoption of ASU No. 2013-02 did not have a material impact on our consolidated financial position or results of operations as the requirements are disclosure only in nature. ASU No. 2013-02 did not impact our disclosures as there were no reclassifications in any periods reported. | |||||||||||||||||||||||||
Pending Adoption of Recent Accounting Pronouncement | |||||||||||||||||||||||||
In July 2013, FASB issued ASU No. 2013-11, Income Taxes (Topic 740), Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists. The provisions of ASU No. 2013-11 require entities to present unrecognized tax benefits as a decrease in a net operating loss, similar tax loss or tax credit carryforward if certain criteria are met. The determination of whether a deferred tax asset is available is based on the unrecognized tax benefit and the deferred tax asset that exists at the reporting date and presumes disallowance of the tax position at the reporting date. The guidance will eliminate the diversity in practice in the presentation of unrecognized tax benefits but will not alter the way in which entities assess deferred tax assets for realizability. The amendments are effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2014. The amendments should be applied prospectively to unrecognized tax benefits that exist at the effective date. Early adoption is permitted. The adoption of ASU No. 2013-11 will not have a material impact on our consolidated financial position or results of operations. | |||||||||||||||||||||||||
Cash Equivalents and Marketable Securities | ' | ||||||||||||||||||||||||
Cash Equivalents and Marketable Securities | |||||||||||||||||||||||||
Cash equivalents consist of highly liquid investments, readily convertible to cash, that mature within ninety days or less from date of purchase. Our cash equivalents consist of money market funds. | |||||||||||||||||||||||||
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 loss and included as a separate component of stockholders' (deficit) equity. 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 income. We use the specific 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 income in the consolidated statement of operations. There were no realized gains or losses during the reporting periods. | |||||||||||||||||||||||||
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 term of such leases. At September 30, 2013 and December 31, 2012, restricted cash of $500,000 and $400,000, respectively, was pledged as collateral for the letters of credit. To conform to the current period presentation, we have reclassified $400,000 from cash and cash equivalents to restricted cash in the consolidated balance sheet at December 31, 2012. | |||||||||||||||||||||||||
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, marketable securities, accounts receivable, prepaid expenses, 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, 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. Further, based on the borrowing rates currently available to us 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 corporate debt securities, commercial paper and certificates of deposit and were measured at fair value using 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 service. 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. | |||||||||||||||||||||||||
The following table summarizes, by major security type, our cash equivalents and marketable securities that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy: | |||||||||||||||||||||||||
September 30, 2013 | 31-Dec-12 | ||||||||||||||||||||||||
Level 1 | Level 2 | Total estimated fair value | Level 1 | Level 2 | Total estimated fair value | ||||||||||||||||||||
Cash equivalents: | |||||||||||||||||||||||||
Money market funds | $ | 11,853,450 | $ | — | $ | 11,853,450 | $ | 98,024,269 | $ | — | $ | 98,024,269 | |||||||||||||
Available-for-sale marketable | |||||||||||||||||||||||||
securities: | |||||||||||||||||||||||||
Corporate debt securities | — | 38,826,192 | 38,826,192 | — | — | — | |||||||||||||||||||
Commercial paper | — | 5,992,659 | 5,992,659 | — | — | — | |||||||||||||||||||
Certificate of deposit | — | 3,000,000 | 3,000,000 | — | — | — | |||||||||||||||||||
$ | 11,853,450 | $ | 47,818,851 | $ | 59,672,301 | $ | 98,024,269 | $ | — | $ | 98,024,269 | ||||||||||||||
There were no transfers between Level 1 and Level 2 of the fair value hierarchy in the nine months ended September 30, 2013 and 2012. We have no instruments that are classified within Level 3 as of September 30, 2013 and December 31, 2012. | |||||||||||||||||||||||||
Inventories | ' | ||||||||||||||||||||||||
Inventories | |||||||||||||||||||||||||
Inventories are stated at lower of cost or market. Cost is determined on a first-in, first-out basis. Inventories are reviewed periodically for potential excess, dated or obsolete status. Management evaluates 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 expense costs relating to the purchase and production of pre-approval inventories for which the sole use is pre-approval products as research and development expense in the period incurred until such time as we believe future commercialization is probable and future economic benefit is expected to be realized. Inventories used in clinical trials are expensed at the time the inventories are packaged for the clinical trials. Prior to receiving approval from the U.S. Food and Drug Administration ("FDA") or comparable regulatory agencies in foreign countries, costs related to purchases of bulk rHuPH20 enzyme ("active pharmaceutical ingredient" or "API") and raw materials and the manufacturing of the product candidates are recorded as research and development expense. All direct manufacturing costs incurred after approval are capitalized as inventory. | |||||||||||||||||||||||||
As of September 30, 2013 and December 31, 2012, inventories consisted of $2.5 million and $2.7 million of Hylenex recombinant inventory, respectively, and $1.3 million and zero of API used in the manufacture of Herceptin SC, respectively. Roche received European marketing approval for its collaboration product, Herceptin® SC, in August 2013 and Baxter for its collaboration product, HyQvia, in May 2013. As such, direct manufacturing costs of API for Herceptin SC and HyQvia incurred after the receipt of the European marketing approvals are being capitalized as inventory. | |||||||||||||||||||||||||
Revenue Recognition | ' | ||||||||||||||||||||||||
Revenue Recognition | |||||||||||||||||||||||||
We generate revenues from product sales and collaborative agreements. Payments received under collaborative agreements may include nonrefundable fees at the inception of the agreements, license fees, milestone payments for specific achievements designated in the collaborative agreements, reimbursements of research and development services and supply of rHuPH20 API, and/or royalties on sales of products resulting from collaborative arrangements. | |||||||||||||||||||||||||
We recognize revenues in accordance with the authoritative guidance for revenue recognition. We recognize revenue when all of the following criteria are 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. | |||||||||||||||||||||||||
Product Sales, Net | |||||||||||||||||||||||||
Hylenex Recombinant | |||||||||||||||||||||||||
In December 2011, we reintroduced Hylenex recombinant to the market and began promoting Hylenex recombinant through our sales force. We sell Hylenex recombinant in the United States to wholesale pharmaceutical distributors, who sell the product to hospitals and other end-user customers. The wholesale distributors take title to the product, bear the risk of loss of ownership and have economic substance to the inventory. Further, we have no significant obligations for future performance to generate pull-through sales; however, we allow the wholesale distributors to return product that is damaged or received in error. In addition, we allow for product to be returned beginning six months prior to and ending twelve months following product expiration. | |||||||||||||||||||||||||
Given our limited history of selling Hylenex recombinant and the lengthy return period, we currently cannot reliably estimate expected returns and chargebacks of Hylenex recombinant at the time the product is received by the wholesale distributors. Therefore, we do not recognize revenue upon delivery of Hylenex recombinant to the wholesale distributor until the point at which we can reliably estimate expected product returns and chargebacks from the wholesale distributors. Shipments of Hylenex recombinant are recorded as deferred revenue until evidence exists to confirm that pull-through sales to the hospitals or other end-user customers have occurred. We recognize revenue when the product is sold through from the distributors to the distributors’ customers. In addition, the costs of manufacturing Hylenex recombinant associated with the deferred revenue are recorded as deferred costs, which are included in inventory, until such time as the related deferred revenue is recognized. We estimate sell-through revenue and certain sales allowances based on analysis of third-party information including information obtained from certain distributors with respect to their inventory levels and sell-through to the distributors’ customers. At the time we can reliably estimate product returns and chargebacks from the wholesale distributors, we will record a one-time increase in net product sales revenue related to the recognition of product sales revenue previously deferred. | |||||||||||||||||||||||||
We recognize product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of our agreements with wholesale distributors and hospitals. We must make significant judgments in determining these allowances. If actual results differ from our estimates, we will be required to make adjustments to these allowances in the future, which could have an effect on product sales revenue in the period of adjustment. | |||||||||||||||||||||||||
Our product sales allowances include: | |||||||||||||||||||||||||
Distribution Fees. The distribution fees, based on contractually determined rates, arise from contractual agreements we have with certain wholesale distributors for distribution services they provide with respect to Hylenex recombinant. At the time the sale is made to the respective wholesale distributors, we record an allowance for distribution fees by reducing our accounts receivable and deferred revenue associated with such product sales. | |||||||||||||||||||||||||
Prompt Payment Discounts. We offer cash discounts to certain wholesale distributors as an incentive to meet certain payment terms. We expect our customers will take advantage of this discount; therefore, at the time the sale is made to the respective wholesale distributors, we accrue the entire prompt payment discount, based on the gross amount of each invoice, by reducing our accounts receivable and deferred revenue associated with such product sales. | |||||||||||||||||||||||||
Other Discounts and Fees. We provide discounts to end-user members of certain group purchasing organizations (“GPO”) under collective purchasing contracts between us and the GPOs. We also provide discounts to certain hospitals, who are members of the GPOs, with which we do not have contracts. The end-user members purchase products from the wholesale distributors at a contracted discounted price, and the wholesale distributors then charge back to us the difference between the current retail price and the price the end-users paid for the product. Given our lack of historical sales data, we recognize these chargebacks in the same period the related product sales revenue is recognized and reduce our accounts receivable accordingly. We incur GPO fees for these transactions which are also recorded in the same period the related product sales revenue is recognized and are included in accrued expenses. | |||||||||||||||||||||||||
Product Returns. The product returns reserve is based on management’s best estimate of the product sales recognized as revenue during the period that are anticipated to be returned. The product returns reserve is recorded as a reduction of product sales revenue in the same period the related product sales revenue is recognized and is included in accrued expenses. | |||||||||||||||||||||||||
rHuPH20 API | |||||||||||||||||||||||||
Subsequent to receiving approval from the FDA or comparable regulatory agencies in foreign countries, sales of API for collaboration commercial products are recognized as product sales when the API has met all the specifications required for the customer's acceptance and title and risk of loss have transferred to the customer. Following the receipts of European marketing approvals of Roche's Herceptin SC product in August 2013 and Baxter's HyQvia product in May 2013, revenue from the sales of API for these collaboration products will be recognized as product sales. For the three and nine months ended September 30, 2013, we recognized product sales of API in the amounts of $7.9 million for Herceptin SC and zero and $1.1 million, respectively, for HyQvia. | |||||||||||||||||||||||||
Revenues under Collaborative Agreements | |||||||||||||||||||||||||
We have license and collaboration agreements under which the collaborators obtained worldwide rights for the use of our proprietary rHuPH20 enzyme in the development and commercialization of the collaborators’ biologic compounds. The collaborative agreements contain multiple elements including nonrefundable payments at the inception of the arrangement, license fees, exclusivity fees, payments based on achievement of specified milestones designated in the collaborative agreements, annual maintenance fees, reimbursements of research and development services, payments for supply of rHuPH20 API for the collaborator and/or royalties on sales of products resulting from collaborative agreements. We analyze each element of our collaborative agreements and consider a variety of factors in determining the appropriate method of revenue recognition of each element. | |||||||||||||||||||||||||
In order to account for the multiple-element arrangements, we identify the deliverables included within the agreement and evaluate which deliverables represent units of accounting. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. The deliverables under our collaborative agreements include (i) the license to our rHuPH20 technology, (ii) at the collaborator’s request, research and development services which are reimbursed at contractually determined rates, and (iii) at the collaborator’s request, supply of rHuPH20 API which is reimbursed at our cost plus a margin. A delivered item is considered a separate unit of accounting when the delivered item has value to the collaborator on a standalone basis based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research capabilities of the collaborator and the availability of research expertise in this field in the general marketplace. | |||||||||||||||||||||||||
Arrangement consideration is allocated at the inception of the agreement to all identified units of accounting based on their relative selling price. The relative selling price for each deliverable is determined using vendor specific objective evidence (“VSOE”) of selling price or third-party evidence of selling price if VSOE does not exist. If neither VSOE nor third-party evidence of selling price exists, we use our best estimate of the selling price for the deliverable. The amount of allocable arrangement consideration is limited to amounts that are not contingent upon the delivery of additional items or meeting other specified performance conditions. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. Changes in the allocation of the sales price between delivered and undelivered elements can impact revenue recognition but do not change the total revenue recognized under any agreement. | |||||||||||||||||||||||||
Nonrefundable upfront license fee payments are recognized upon delivery of the license if facts and circumstances dictate that the license has standalone value from the undelivered items, which generally include research and development services and the manufacture of rHuPH20 API, the relative selling price allocation of the license is equal to or exceeds the upfront license fee, persuasive evidence of an arrangement exists, our price to the collaborator is fixed or determinable and collectibility is reasonably assured. Upfront license fee payments are deferred if facts and circumstances dictate that the license does not have standalone value. The determination of the length of the period over which to defer revenue is subject to judgment and estimation and can have an impact on the amount of revenue recognized in a given period. | |||||||||||||||||||||||||
Prior to the adoption of ASU No. 2009-13, Multiple-Deliverable Revenue Arrangements, on January 1, 2011, in order for a delivered item to be accounted for separately from other deliverables in a multiple-element arrangement, the following three criteria had to be met: (i) the delivered item had standalone value to the customer, (ii) there was objective and reliable evidence of fair value of the undelivered items and (iii) if the arrangement included a general right of return relative to the delivered item, delivery or performance of the undelivered items was considered probable and substantially in the control of the vendor. For the collaborative agreements entered into prior to January 1, 2011, there was no objective and reliable evidence of fair value of the undelivered items. Thus, the delivered licenses did not meet all of the required criteria to be accounted for separately from undelivered items. Therefore, we recognize revenue on nonrefundable upfront payments and license fees from these collaborative agreements over the period of significant involvement under the related agreements. | |||||||||||||||||||||||||
The terms of our collaborative agreements provide for milestone payments upon achievement of certain development and regulatory events and/or specified sales volumes of commercialized products by the collaborator. We account for milestone payments in accordance with the provisions of ASU No. 2010-17, Revenue Recognition - Milestone Method. We recognize consideration that is contingent upon the achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone is substantive in its entirety. A milestone is considered substantive when it meets all of the following criteria: | |||||||||||||||||||||||||
1 | The consideration is commensurate with either the entity’s performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, | ||||||||||||||||||||||||
2 | The consideration relates solely to past performance, and | ||||||||||||||||||||||||
3 | The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. | ||||||||||||||||||||||||
A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity’s performance or on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to the vendor. | |||||||||||||||||||||||||
Reimbursements of research and development services are recognized as revenue during the period in which the services are performed as long as there is persuasive evidence of an arrangement, the fee is fixed or determinable and collection of the related receivable is reasonably assured. Revenue from the manufacture of rHuPH20 API is recognized when the API has met all specifications required for the collaborator's acceptance and title and risk of loss have transferred to the collaborator. We do not directly control when any collaborator will request research and development services or supply of rHuPH20 API; therefore, we cannot predict when we will recognize revenues in connection with research and development services and supply of rHuPH20 API. | |||||||||||||||||||||||||
Royalty revenue from sales of collaboration products by our collaborators will be recognized when received, which is generally in the quarter following the quarter in which the corresponding sales occur. | |||||||||||||||||||||||||
The collaborative agreements typically provide the collaborators the right to terminate such agreement in whole or on a product-by-product or target-by-target basis at any time upon 30 to 90 days prior written notice to us. There are no performance, cancellation, termination or refund provisions in any of our collaborative agreements that contain material financial consequences to us. | |||||||||||||||||||||||||
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. Cost of product sales also consists of the write-down of excess, dated and obsolete inventories and the write-off of any inventories that do not meet certain product specifications. Prior to European marketing approvals of Herceptin SC and HyQvia, all costs related to the manufacturing of API for these products were charged to research and development expenses in the periods such costs were incurred. Therefore, there was minimal cost recognized for the product sales of API for these collaboration products in the three and nine months ended September 30, 2013. Of the Herceptin SC API on hand as of September 30, 2013, $2.6 million in manufacturing costs have been previously recorded as research and development expenses. | |||||||||||||||||||||||||
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 operations as incurred when these expenditures relate to our research and development efforts and have no alternative future uses. Costs related to purchases of API and the manufacturing of a collaboration product incurred after receiving approval from the FDA or comparable regulatory agencies in foreign countries for such product are capitalized as inventory. The manufacturing costs of API for Herceptin SC and HyQvia incurred after the receipt of the European marketing approvals are capitalized as inventory. | |||||||||||||||||||||||||
In accordance with certain research and development agreements, we are obligated to make certain upfront payments upon execution of the agreement. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts will be recognized as an 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 or product candidates are expensed as incurred when there is uncertainty in receiving future economic benefits from the licensed technology or product candidates. We consider the future economic benefits from the licensed technology or product candidates to be uncertain until such licensed technology or product candidates are approved for marketing by the regulatory bodies such as the FDA or when other significant risk factors are abated. Management has viewed future economic benefits for all of our licensed technology or product candidates to be uncertain and has expensed these amounts as incurred. | |||||||||||||||||||||||||
Clinical Trial Expenses | ' | ||||||||||||||||||||||||
Clinical Trial Expenses | |||||||||||||||||||||||||
Payments in connection with our clinical trials are often made under contracts with multiple contract research organizations that conduct and manage clinical trials on our behalf. 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-material basis. Payments under these contracts depend 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 contracted amounts are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), we modify our accruals accordingly on a prospective basis. Revisions in the scope of a contract are charged to expense in the period in which the facts that give rise to the revision become reasonably certain. Historically, we have had no material changes in clinical trial expense accruals that would have had a material impact on our consolidated results of operations or financial position. | |||||||||||||||||||||||||
Share-Based Compensation | ' | ||||||||||||||||||||||||
Share-Based Compensation | |||||||||||||||||||||||||
Total share-based compensation expense related to all of our share-based awards was allocated as follows: | |||||||||||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||||||||||
September 30, | September 30, | ||||||||||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||||||||||
Research and development | $ | 1,089,249 | $ | 913,946 | $ | 3,351,629 | $ | 3,279,940 | |||||||||||||||||
Selling, general and administrative | 1,214,413 | 1,008,447 | 3,788,369 | 3,082,432 | |||||||||||||||||||||
Share-based compensation expense | $ | 2,303,662 | $ | 1,922,393 | $ | 7,139,998 | $ | 6,362,372 | |||||||||||||||||
Net share-based compensation expense, per basic and diluted share | $ | 0.02 | $ | 0.02 | $ | 0.06 | $ | 0.06 | |||||||||||||||||
Share-based compensation expense from: | |||||||||||||||||||||||||
Stock options | $ | 1,284,364 | $ | 1,164,973 | $ | 4,068,793 | $ | 3,491,220 | |||||||||||||||||
Restricted stock awards and restricted stock units | 1,019,298 | 757,420 | 3,071,205 | 2,871,152 | |||||||||||||||||||||
$ | 2,303,662 | $ | 1,922,393 | $ | 7,139,998 | $ | 6,362,372 | ||||||||||||||||||
Since we have a net operating loss carryforward as of September 30, 2013, no excess tax benefits for the tax deductions related to share-based awards were recognized in the interim unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2013. | |||||||||||||||||||||||||
As of September 30, 2013, total unrecognized estimated compensation cost related to non-vested stock options and non-vested restricted stock awards and restricted stock units granted prior to that date was approximately $10.4 million and $7.8 million, respectively, which is expected to be recognized over a weighted-average period of approximately 2.7 years and 2.9 years, respectively. | |||||||||||||||||||||||||
Net Loss Per Share | ' | ||||||||||||||||||||||||
Net Loss Per Share | |||||||||||||||||||||||||
Basic net loss per common share is computed by dividing loss for the period by the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents. Stock options, unvested restricted stock awards (“RSAs”) and unvested restricted stock units ("RSUs") are considered common stock equivalents and are only included in the calculation of diluted earnings per common share when their effect is dilutive. Because of our net loss, outstanding stock options, outstanding RSUs and unvested RSAs totaling approximately 8.6 million and 7.3 million were excluded from the calculation of diluted net loss per common share for the three and nine months ended September 30, 2013 and 2012, respectively, because their effect is anti-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 that can be used to facilitate the delivery of injected drugs and fluids, thus enhancing the efficacy and the convenience of other drugs or to alter abnormal tissue structures for clinical benefit. This segment also includes revenues and expenses related to (i) research and development and API 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. |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Tables) | 9 Months Ended | ||||||||||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||||||||||
Accounting Policies [Abstract] | ' | ||||||||||||||||||||||||
Fair value, assets measured on recurring basis | ' | ||||||||||||||||||||||||
The following table summarizes, by major security type, our cash equivalents and marketable securities that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy: | |||||||||||||||||||||||||
September 30, 2013 | 31-Dec-12 | ||||||||||||||||||||||||
Level 1 | Level 2 | Total estimated fair value | Level 1 | Level 2 | Total estimated fair value | ||||||||||||||||||||
Cash equivalents: | |||||||||||||||||||||||||
Money market funds | $ | 11,853,450 | $ | — | $ | 11,853,450 | $ | 98,024,269 | $ | — | $ | 98,024,269 | |||||||||||||
Available-for-sale marketable | |||||||||||||||||||||||||
securities: | |||||||||||||||||||||||||
Corporate debt securities | — | 38,826,192 | 38,826,192 | — | — | — | |||||||||||||||||||
Commercial paper | — | 5,992,659 | 5,992,659 | — | — | — | |||||||||||||||||||
Certificate of deposit | — | 3,000,000 | 3,000,000 | — | — | — | |||||||||||||||||||
$ | 11,853,450 | $ | 47,818,851 | $ | 59,672,301 | $ | 98,024,269 | $ | — | $ | 98,024,269 | ||||||||||||||
Share-based compensation expense related to share-based awards | ' | ||||||||||||||||||||||||
Total share-based compensation expense related to all of our share-based awards was allocated as follows: | |||||||||||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||||||||||
September 30, | September 30, | ||||||||||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||||||||||
Research and development | $ | 1,089,249 | $ | 913,946 | $ | 3,351,629 | $ | 3,279,940 | |||||||||||||||||
Selling, general and administrative | 1,214,413 | 1,008,447 | 3,788,369 | 3,082,432 | |||||||||||||||||||||
Share-based compensation expense | $ | 2,303,662 | $ | 1,922,393 | $ | 7,139,998 | $ | 6,362,372 | |||||||||||||||||
Net share-based compensation expense, per basic and diluted share | $ | 0.02 | $ | 0.02 | $ | 0.06 | $ | 0.06 | |||||||||||||||||
Share-based compensation expense from: | |||||||||||||||||||||||||
Stock options | $ | 1,284,364 | $ | 1,164,973 | $ | 4,068,793 | $ | 3,491,220 | |||||||||||||||||
Restricted stock awards and restricted stock units | 1,019,298 | 757,420 | 3,071,205 | 2,871,152 | |||||||||||||||||||||
$ | 2,303,662 | $ | 1,922,393 | $ | 7,139,998 | $ | 6,362,372 | ||||||||||||||||||
Marketable_Securities_Tables
Marketable Securities (Tables) | 9 Months Ended | |||||||||||||||||
Sep. 30, 2013 | ||||||||||||||||||
Marketable Securities [Abstract] | ' | |||||||||||||||||
Available-for-sale securities | ' | |||||||||||||||||
Available-for-sale marketable securities consist of the following: | ||||||||||||||||||
September 30, 2013 | ||||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||||
Corporate debt securities | $ | 38,810,413 | $ | 18,279 | $ | (2,500 | ) | $ | 38,826,192 | |||||||||
Commercial paper | 5,992,659 | — | — | 5,992,659 | ||||||||||||||
Certificate of deposit | 3,000,000 | — | — | 3,000,000 | ||||||||||||||
$ | 47,803,072 | $ | 18,279 | $ | (2,500 | ) | $ | 47,818,851 | ||||||||||
Certain_Balance_Sheet_Items_Ta
Certain Balance Sheet Items (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Balance Sheet Related Disclosures [Abstract] | ' | ||||||||
Summary of Accounts Receivable | ' | ||||||||
Accounts receivable, net consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Accounts receivable from revenues under collaborative agreements | $ | 15,474,799 | $ | 15,058,163 | |||||
Accounts receivable from product sales to collaborators | 7,931,957 | — | |||||||
Accounts receivable from other product sales | 1,512,236 | 823,064 | |||||||
24,918,992 | 15,881,227 | ||||||||
Allowance for distribution fees and discounts | (397,250 | ) | (178,140 | ) | |||||
$ | 24,521,742 | $ | 15,703,087 | ||||||
Summary of Inventories | ' | ||||||||
Inventories consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Raw materials | $ | 1,218,406 | $ | 1,127,061 | |||||
Work-in-process | 1,580,610 | 792,257 | |||||||
Finished goods | 1,047,274 | 751,378 | |||||||
$ | 3,846,290 | $ | 2,670,696 | ||||||
Summary of Prepaid Expenses and Other Assets | ' | ||||||||
Prepaid expenses and other assets, current consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Prepaid manufacturing expenses | $ | 5,720,041 | $ | 8,152,602 | |||||
Prepaid research and development expenses | 3,121,834 | 2,274,551 | |||||||
Other prepaid expenses | 1,603,147 | 2,250,791 | |||||||
Other assets | 585,162 | 74,944 | |||||||
11,030,184 | 12,752,888 | ||||||||
Less long-term portion | 1,891,170 | — | |||||||
$ | 9,139,014 | $ | 12,752,888 | ||||||
Summary of Property and Equipment | ' | ||||||||
Property and equipment, net consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Research equipment | $ | 6,714,830 | $ | 6,360,004 | |||||
Computer and office equipment | 1,738,669 | 1,432,975 | |||||||
Leasehold improvements | 1,272,151 | 1,138,110 | |||||||
Building (1) | 2,550,000 | 1,450,000 | |||||||
12,275,650 | 10,381,089 | ||||||||
Accumulated depreciation and amortization | (7,339,722 | ) | (6,680,627 | ) | |||||
$ | 4,935,928 | $ | 3,700,462 | ||||||
__________________ | |||||||||
-1 | Represents capitalized building under a build-to-suit lease arrangement where we are considered the owner (for accounting purposes only) during the construction period. | ||||||||
Summary of Accrued Expenses | ' | ||||||||
Accrued expenses consist of the following: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Accrued outsourced manufacturing expenses | $ | 8,613,848 | $ | 984,192 | |||||
Accrued outsourced research and development expenses | 4,496,267 | 1,239,050 | |||||||
Accrued compensation and payroll taxes | 5,351,965 | 4,053,590 | |||||||
Other accrued expenses | 2,162,421 | 1,506,615 | |||||||
$ | 20,624,501 | $ | 7,783,447 | ||||||
Summary of Deferred Revenue | ' | ||||||||
Deferred revenue consists of the following: | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Collaborative agreements | $ | 49,481,253 | $ | 43,222,473 | |||||
Product sales | 3,896,691 | 623,510 | |||||||
Total deferred revenue | 53,377,944 | 43,845,983 | |||||||
Less current portion | 7,437,433 | 8,891,017 | |||||||
Deferred revenue, net of current portion | $ | 45,940,511 | $ | 34,954,966 | |||||
Summary_of_Significant_Account3
Summary of Significant Accounting Policies - Restricted Cash (Details) (USD $) | 9 Months Ended | |
Sep. 30, 2013 | Dec. 31, 2012 | |
Restricted Cash and Investments, Current [Abstract] | ' | ' |
Restricted cash | $500,000 | $400,000 |
Prior period reclassification adjustment | $400,000 | ' |
Summary_of_Significant_Account4
Summary of Significant Accounting Policies - Fair Value Measurements (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Assets Measured on Recurring Basis | ' | ' |
Available-for-sale securities, fair value disclosure | $47,818,851 | ' |
Assets, fair value disclosure | 59,672,301 | 98,024,269 |
Fair value, assets, Level 1 to Level 2 transfers, amount | 0 | 0 |
Level 1 | ' | ' |
Assets Measured on Recurring Basis | ' | ' |
Assets, fair value disclosure | 11,853,450 | 98,024,269 |
Level 2 | ' | ' |
Assets Measured on Recurring Basis | ' | ' |
Assets, fair value disclosure | 47,818,851 | 0 |
Level 3 | ' | ' |
Assets Measured on Recurring Basis | ' | ' |
Investments, fair value disclosure | 0 | 0 |
Cash equivalents | ' | ' |
Assets Measured on Recurring Basis | ' | ' |
Cash and cash equivalents, fair value disclosure | 11,853,450 | 98,024,269 |
Cash equivalents | Level 1 | ' | ' |
Assets Measured on Recurring Basis | ' | ' |
Cash and cash equivalents, fair value disclosure | 11,853,450 | 98,024,269 |
Corporate debt securities | ' | ' |
Assets Measured on Recurring Basis | ' | ' |
Available-for-sale securities, fair value disclosure | 38,826,192 | 0 |
Corporate debt securities | Level 2 | ' | ' |
Assets Measured on Recurring Basis | ' | ' |
Available-for-sale securities, fair value disclosure | 38,826,192 | 0 |
Commercial paper | ' | ' |
Assets Measured on Recurring Basis | ' | ' |
Available-for-sale securities, fair value disclosure | 5,992,659 | 0 |
Commercial paper | Level 2 | ' | ' |
Assets Measured on Recurring Basis | ' | ' |
Available-for-sale securities, fair value disclosure | 5,992,659 | 0 |
Certificate of deposit | ' | ' |
Assets Measured on Recurring Basis | ' | ' |
Available-for-sale securities, fair value disclosure | 3,000,000 | 0 |
Certificate of deposit | Level 2 | ' | ' |
Assets Measured on Recurring Basis | ' | ' |
Available-for-sale securities, fair value disclosure | $3,000,000 | $0 |
Summary_of_Significant_Account5
Summary of Significant Accounting Policies Inventories (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Millions, unless otherwise specified | ||
Hylenex recombinant | ' | ' |
Inventory [Line Items] | ' | ' |
Inventories | $2.50 | $2.70 |
rHuPH20 enzyme (API) | ' | ' |
Inventory [Line Items] | ' | ' |
Inventories | $1.30 | $0 |
Summary_of_Significant_Account6
Summary of Significant Accounting Policies Product sales rHuPH20 API (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Product Information | ' | ' | ' | ' |
Product sales | $10,024,902 | $715,354 | $14,633,349 | $1,427,707 |
API for Herceptin SC | ' | ' | ' | ' |
Product Information | ' | ' | ' | ' |
Product sales | 7,900,000 | ' | 7,900,000 | ' |
API for HyQvia | ' | ' | ' | ' |
Product Information | ' | ' | ' | ' |
Product sales | $0 | ' | $1,100,000 | ' |
Summary_of_Significant_Account7
Summary of Significant Accounting Policies Revenue recognition (Details) | 9 Months Ended |
Sep. 30, 2013 | |
Maximum | ' |
Collaborative agreements termination notification | ' |
Notification period for termination | '90 days |
Minimum | ' |
Collaborative agreements termination notification | ' |
Notification period for termination | '30 days |
Summary_of_Significant_Account8
Summary of Significant Accounting Policies Cost of Product Sales (Details) (API for Herceptin SC, USD $) | 9 Months Ended |
In Millions, unless otherwise specified | Sep. 30, 2013 |
API for Herceptin SC | ' |
Manufacturing costs previously recorded as research and development | $2.60 |
ShareBased_Compensation_Detail
- Share-Based Compensation (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Share-based compensation expense | ' | ' | ' | ' |
Share-based compensation expense | $2,303,662 | $1,922,393 | $7,139,998 | $6,362,372 |
Share-based compensation expense per basic and diluted share | $0.02 | $0.02 | $0.06 | $0.06 |
Stock options | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | ' | ' |
Share-based compensation expense | 1,284,364 | 1,164,973 | 4,068,793 | 3,491,220 |
Restricted stock awards and restricted stock units | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | ' | ' |
Share-based compensation expense | 1,019,298 | 757,420 | 3,071,205 | 2,871,152 |
Research and development | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | ' | ' |
Share-based compensation expense | 1,089,249 | 913,946 | 3,351,629 | 3,279,940 |
Selling, general and administrative | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | ' | ' |
Share-based compensation expense | $1,214,413 | $1,008,447 | $3,788,369 | $3,082,432 |
Recovered_Sheet1
- Share-based Compensation (Details Textual) (USD $) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2013 | Sep. 30, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Excess tax benefits | $0 | $0 |
Stock options | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Total unrecognized estimated compensation cost related to non-vested stock options | 10,400,000 | 10,400,000 |
Weighted-average period of non-vested awards | ' | '2 years 8 months |
Restricted stock awards and restricted stock units | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Total unrecognized estimated compensation cost of non-vested restricted stock awards and restricted stock units | $7,800,000 | $7,800,000 |
Weighted-average period of non-vested awards | ' | '2 years 11 months |
Summary_of_Significant_Account9
Summary of Significant Accounting Policies - Net Loss Per Share (Details) | 3 Months Ended | 9 Months Ended | ||
In Millions, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Earnings Per Share, Diluted [Abstract] | ' | ' | ' | ' |
Antidilutive securities excluded from computation of earnings per share, amount | 8.6 | 7.3 | 8.6 | 7.3 |
Marketable_Securities_Details
Marketable Securities (Details) (USD $) | 9 Months Ended |
Sep. 30, 2013 | |
Schedule of Available-for-sale Securities | ' |
Amortized cost | $47,803,072 |
Gross unrealized gains | 18,279 |
Gross unrealized losses | -2,500 |
Estimated fair value | 47,818,851 |
Corporate debt securities | ' |
Schedule of Available-for-sale Securities | ' |
Amortized cost | 38,810,413 |
Gross unrealized gains | 18,279 |
Gross unrealized losses | -2,500 |
Estimated fair value | 38,826,192 |
Commercial paper | ' |
Schedule of Available-for-sale Securities | ' |
Amortized cost | 5,992,659 |
Gross unrealized gains | 0 |
Gross unrealized losses | 0 |
Estimated fair value | 5,992,659 |
Certificate of deposit | ' |
Schedule of Available-for-sale Securities | ' |
Amortized cost | 3,000,000 |
Gross unrealized gains | 0 |
Gross unrealized losses | 0 |
Estimated fair value | $3,000,000 |
Marketable_Securities_Marketab
Marketable Securities Marketable Securities Textuals (Details) (USD $) | 9 Months Ended |
Sep. 30, 2013 | |
Marketable Securities [Abstract] | ' |
Available-for-sale securities maturities, next twelve months | $47,800,000 |
Available-for-sale securities, sold | 0 |
Available-for-sale securities, continuous unrealized loss position, twelve months or longer, fair value | $0 |
Collaborative_Agreements_Colla
Collaborative Agreements Collaborative Agreements Textuals (Details) (USD $) | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Dec. 31, 2012 |
Roche collaboration | Roche collaboration | Roche collaboration | Roche collaboration | Gammagard collaboration | Gammagard collaboration | Gammagard collaboration | Gammagard collaboration | Pfizer, ViroPharma and Intrexon | Pfizer, ViroPharma and Intrexon | Pfizer, ViroPharma and Intrexon | Pfizer, ViroPharma and Intrexon | Pfizer collaboration | Pfizer collaboration | ViroPharma | Intrexon | Roche collaboration | Roche collaboration | Gammagard collaboration | Gammagard collaboration | ||
Compound | Compound | Compound | |||||||||||||||||||
Collaborative Agreements Terms | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of product compound combinations licenced to develop | ' | ' | ' | 13 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6 | 6 | ' | ' | ' | ' | ' | ' |
Number of targets elected | ' | ' | ' | 5 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3 | 4 | ' | ' | ' | ' | ' | ' |
Number of additional targets, optional | ' | ' | ' | 3 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2 | ' | ' | ' | ' | ' | ' |
Number of targets elected - upfront licence fee payment | ' | ' | ' | 3 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of targets elected, additional exclusive targets | ' | ' | ' | 2 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Duration of royalty receivable | ' | ' | ' | '10 years | ' | ' | ' | '10 years | ' | ' | ' | ' | ' | ' | '10 years | '10 years | '10 years | ' | ' | ' | ' |
Notification period for termination | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '30 days | '90 days | '90 days | ' | ' | ' | ' |
Collaborative Agreements (Textual) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds, inception to date, from collaborator of license and collaborative agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $14,000,000 | $11,000,000 | $71,750,000 | ' | $17,000,000 | ' |
Nonrefundable upfront license fee payment received under collaborative agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 11,000,000 | 9,000,000 | 9,000,000 | 20,000,000 | ' | 10,000,000 | ' |
Revenue recognized in prior periods | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 11,000,000 | 9,000,000 | 9,000,000 | ' | ' | ' | ' |
Amount received for additional exclusive targets and annual license maintenance fees under collaborative agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 20,750,000 | ' | ' | ' |
Clinical development milestone payments received under collaborative agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3,000,000 | ' | 13,000,000 | ' | ' | ' |
Regulatory milestone payments received under collaborative agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 8,000,000 | ' | 3,000,000 | ' |
Amount received for sales-based payment | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 10,000,000 | 0 | 4,000,000 | 0 |
Deferred revenue, revenue recognized | ' | 575,000 | 503,000 | 3,900,000 | 1,500,000 | 174,000 | 121,000 | 415,000 | 362,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Revenue Recognition, Milestone Method, Revenue Recognized | ' | ' | 0 | ' | 4,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Recognized payment of revenue under collaborative agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | 0 | 0 | 0 | ' | ' | ' | ' | ' | ' | ' | ' |
Additional maximum proceeds receivable from collaborators of license and collaborative agreement upon achievement of clinical development milestones for elected targets | 68,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional achievement of regulatory milestones | 84,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Deferred Revenue (Textual) [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Deferred revenue relating to upfront payment license fees and annual maintenance fees | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $42,000,000 | $35,900,000 | $10,700,000 | $7,100,000 |
Collaborative_Agreements_Subse
Collaborative Agreements Subsequent Event - Collaborative Agreements (Details) (Roche collaboration, USD $) | Sep. 30, 2013 |
In Thousands, unless otherwise specified | |
Roche collaboration | ' |
Subsequent Event [Line Items] | ' |
Amount received for sales-based payment | $10,000 |
Certain_Balance_Sheet_Items_Ac
Certain Balance Sheet Items - Accounts receivable (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Accounts Receivable, Net, Current [Abstract] | ' | ' |
Accounts receivable from revenues under collaborative agreements | $15,474,799 | $15,058,163 |
Accounts receivable from product sales to collaborators | 7,931,957 | 0 |
Accounts receivable from product sales | 1,512,236 | 823,064 |
Accounts receivable, gross | 24,918,992 | 15,881,227 |
Allowance for distribution fees and discounts | -397,250 | -178,140 |
Accounts receivable, net | $24,521,742 | $15,703,087 |
Certain_Balance_Sheet_Items_In
Certain Balance Sheet Items - Inventories (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Summary of Inventories | ' | ' |
Raw materials | $1,218,406 | $1,127,061 |
Work-in-process | 1,580,610 | 792,257 |
Finished goods | 1,047,274 | 751,378 |
Inventories | $3,846,290 | $2,670,696 |
Certain_Balance_Sheet_Items_Pr
Certain Balance Sheet Items - Prepaid expenses and other assets (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Prepaid Expense and Other Assets, Current [Abstract] | ' | ' |
Prepaid manufacturing expenses | $5,720,041 | $8,152,602 |
Prepaid research and development expenses | 3,121,834 | 2,274,551 |
Other prepaid expenses | 1,603,147 | 2,250,791 |
Other assets | 585,162 | 74,944 |
Prepaid expense and other assets | 11,030,184 | 12,752,888 |
Less long-term portion | 1,891,170 | 0 |
Prepaid expense and other assets, current | $9,139,014 | $12,752,888 |
Certain_Balance_Sheet_Items_Pr1
Certain Balance Sheet Items - Property and Equipment (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 | ||
Property and equipment, gross | $12,275,650 | $10,381,089 | ||
Accumulated depreciation and amortization | -7,339,722 | -6,680,627 | ||
Property and equipment, net | 4,935,928 | 3,700,462 | ||
Research equipment | ' | ' | ||
Property and equipment, gross | 6,714,830 | 6,360,004 | ||
Computer and office equipment | ' | ' | ||
Property and equipment, gross | 1,738,669 | 1,432,975 | ||
Leasehold improvements | ' | ' | ||
Property and equipment, gross | 1,272,151 | 1,138,110 | ||
Building | ' | ' | ||
Property and equipment, gross | $2,550,000 | [1] | $1,450,000 | [1] |
[1] | Represents capitalized building under a build-to-suit lease arrangement where we are considered the owner (for accounting purposes only) during the construction period. |
Certain_Balance_Sheet_Items_Pr2
Certain Balance Sheet Items - Property and Equipment, Net (Textuals) (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Depreciation and amortization | ' | ' | ' | ' |
Depreciation and amortization expense | $301,000 | $286,000 | $893,000 | $796,000 |
Certain_Balance_Sheet_Items_Ac1
Certain Balance Sheet Items - Accrued Expenses (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Summary of Accrued Expenses | ' | ' |
Accrued outsourced manufacturing expenses | $8,613,848 | $984,192 |
Accrued outsourced research and development expenses | 4,496,267 | 1,239,050 |
Accrued compensation and payroll taxes | 5,351,965 | 4,053,590 |
Other accrued expenses | 2,162,421 | 1,506,615 |
Total accrued expenses | $20,624,501 | $7,783,447 |
Certain_Balance_Sheet_Items_De
Certain Balance Sheet Items - Deferred Revenue (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Deferred revenue | ' | ' |
Deferred revenue | $53,377,944 | $43,845,983 |
Deferred revenue, current | 7,437,433 | 8,891,017 |
Deferred revenue, net of current portion | 45,940,511 | 34,954,966 |
Collaborative arrangement | ' | ' |
Deferred revenue | ' | ' |
Deferred revenue | 49,481,253 | 43,222,473 |
Product sales | ' | ' |
Deferred revenue | ' | ' |
Deferred revenue | $3,896,691 | $623,510 |
LongTerm_Debt_LongTerm_Debt_Te
Long-Term Debt Long-Term Debt Textuals (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | |
Secured Debt | Secured Debt | Secured Debt | Secured Debt | |||
Minimum | Maximum | |||||
Debt Instrument [Line Items] | ' | ' | ' | ' | ' | ' |
Face amount | ' | ' | ' | $30,000,000 | ' | ' |
Issuance date | ' | ' | 28-Dec-12 | ' | ' | ' |
Maturity date | ' | ' | 1-Jan-17 | ' | ' | ' |
Interest rate, stated percentage | ' | ' | 7.55% | ' | ' | ' |
Interest only period of one year | ' | ' | '12 months | ' | ' | ' |
Payment, term after initial interest only period of one year | ' | ' | '36 months | ' | ' | ' |
Final payment | ' | ' | 2,550,000 | ' | ' | ' |
Prepayment fee, percent | ' | ' | ' | ' | 1.00% | 3.00% |
Accrued interest, noncurrent | ' | ' | 921,000 | ' | ' | ' |
Debt instrument, covenant in compliance | ' | 'SeptemberB 30, 2013 | ' | ' | ' | ' |
Interest Expense, debt | $850,000 | $2,500,000 | ' | ' | ' | ' |
Stockholders_Deficit_Equity_De
Stockholders' (Deficit) Equity (Details) (USD $) | 1 Months Ended | 9 Months Ended | |||
Feb. 29, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | Feb. 15, 2012 | |
Stockholders' (deficit) equity (textual) | ' | ' | ' | ' | ' |
Outstanding stock options and restricted stock units | ' | 7,900,000 | ' | 7,100,000 | ' |
Common stock, shares authorized | ' | 200,000,000 | ' | 150,000,000 | ' |
Increase in shares of common stock approved for grant | ' | ' | 6,500,000 | ' | ' |
Underwritten public offering and issued shares | 7,820,000 | ' | ' | ' | ' |
Stock issued during period shares new issues to underwriter | 1,020,000 | ' | ' | ' | ' |
Sale of stock, price per share | ' | ' | ' | ' | $10.61 |
Proceeds from issuance of common stock | $81,500,000 | $0 | $81,476,845 | ' | ' |
Stock options | ' | ' | ' | ' | ' |
Stockholders' (deficit) equity (textual) | ' | ' | ' | ' | ' |
Number of shares of common stock issued as a result of stock option exercises | ' | 726,538 | 426,277 | ' | ' |
Stock options weighted average exercise price | ' | $3.26 | $4.56 | ' | ' |
Net proceeds from stock options exercised | ' | 2,400,000 | 1,900,000 | ' | ' |
Restricted stock units | ' | ' | ' | ' | ' |
Stockholders' (deficit) equity (textual) | ' | ' | ' | ' | ' |
Number of RSUs surrendered to pay for minimum withholding taxes | ' | 58,061 | 46,930 | ' | ' |
Payments for tax withholding for restricted stock units vested, net | ' | 374,000 | 347,000 | ' | ' |
Stock issued during period, shares, restricted stock award, net of forfeitures | ' | 85,782 | 81,070 | ' | ' |
Restricted stock awards | ' | ' | ' | ' | ' |
Stockholders' (deficit) equity (textual) | ' | ' | ' | ' | ' |
Stock issued during period, shares, restricted stock award, net of forfeitures | ' | 465,245 | 375,908 | ' | ' |
Affiliate | ' | ' | ' | ' | ' |
Stockholders' (deficit) equity (textual) | ' | ' | ' | ' | ' |
Underwritten public offering and issued shares | 1,360,000 | ' | ' | ' | ' |
Sale of stock, price per share | ' | ' | ' | ' | $10.61 |
Proceeds from issuance of common stock | $14,400,000 | ' | ' | ' | ' |