Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Aug. 02, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | DVAX | |
Entity Registrant Name | Dynavax Technologies Corp | |
Entity Central Index Key | 0001029142 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 65,154,729 | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-34207 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 33-0728374 | |
Entity Address, Address Line One | 2100 Powell Street | |
Entity Address, Address Line Two | Suite 900 | |
Entity Address, City or Town | Emeryville | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94608 | |
City Area Code | 510 | |
Local Phone Number | 848-5100 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 34,225 | $ 49,348 |
Marketable securities available-for-sale | 106,269 | 96,188 |
Accounts and other receivables, net | 7,582 | 3,704 |
Inventories, net | 36,629 | 19,022 |
Prepaid expenses and other current assets | 6,745 | 6,102 |
Total current assets | 191,450 | 174,364 |
Property and equipment, net | 34,393 | 17,064 |
Intangible assets, net | 7,147 | 11,717 |
Operating lease right-of-use assets | 29,533 | |
Goodwill | 2,131 | 2,144 |
Restricted cash | 628 | 619 |
Other assets | 1,799 | 4,976 |
Total assets | 267,081 | 210,884 |
Current liabilities: | ||
Accounts payable | 11,226 | 5,278 |
Accrued research and development | 5,501 | 9,714 |
Accrued liabilities | 19,550 | 16,041 |
Other current liabilities | 8,296 | 7,000 |
Total current liabilities | 44,573 | 38,033 |
Long-term debt, net | 176,636 | 100,871 |
Long-term portion of lease liabilities | 34,641 | |
Other long-term liabilities | 643 | 8,915 |
Total liabilities | 256,493 | 147,819 |
Commitments and contingencies (Note 6) | ||
Stockholders’ equity: | ||
Preferred stock: $0.001 par value; 5,000 shares authorized at June 30, 2019 and December 31, 2018; no shares issued and outstanding at June 30, 2019 and December 31, 2018 | ||
Common stock: $0.001 par value; 139,000 shares authorized at June 30, 2019 and December 31, 2018; 65,155 and 62,862 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 65 | 63 |
Additional paid-in capital | 1,161,115 | 1,131,241 |
Accumulated other comprehensive loss | (1,983) | (2,015) |
Accumulated deficit | (1,148,609) | (1,066,224) |
Total stockholders’ equity | 10,588 | 63,065 |
Total liabilities and stockholders’ equity | $ 267,081 | $ 210,884 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 139,000,000 | 139,000,000 |
Common stock, shares issued | 65,155,000 | 62,862,000 |
Common stock, shares outstanding | 65,154,729 | 62,862,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenues: | ||||
Total revenues | $ 8,301 | $ 1,254 | $ 14,074 | $ 1,419 |
Operating expenses: | ||||
Cost of sales - amortization of intangible assets | 2,300 | 2,300 | 4,570 | 4,715 |
Research and development | 16,196 | 16,273 | 37,402 | 35,239 |
Selling, general and administrative | 17,861 | 15,653 | 36,209 | 32,544 |
Restructuring | 8,777 | 8,777 | ||
Total operating expenses | 47,272 | 39,401 | 90,899 | 77,880 |
Loss from operations | (38,971) | (38,147) | (76,825) | (76,461) |
Other income (expense): | ||||
Interest income | 979 | 1,153 | 1,714 | 1,893 |
Interest expense | (4,598) | (2,691) | (7,332) | (3,852) |
Other (expense) income, net | (123) | 241 | 58 | 18 |
Net loss | $ (42,713) | $ (39,444) | $ (82,385) | $ (78,402) |
Basic and diluted net loss per share | $ (0.66) | $ (0.63) | $ (1.28) | $ (1.26) |
Weighted average shares used to compute basic and diluted net loss per share | 65,088 | 62,346 | 64,436 | 62,047 |
Product | ||||
Revenues: | ||||
Total revenues | $ 8,301 | $ 1,254 | $ 13,928 | $ 1,419 |
Operating expenses: | ||||
Cost of sales - product | 2,141 | 5,177 | 3,941 | 5,382 |
Cost of sales - amortization of intangible assets | $ 2,297 | $ 2,298 | 4,570 | $ 4,715 |
Collaboration Revenue | ||||
Revenues: | ||||
Total revenues | $ 146 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (42,713) | $ (39,444) | $ (82,385) | $ (78,402) |
Other comprehensive income (loss), net of tax: | ||||
Unrealized gain (loss) on marketable securities available-for-sale | 108 | 17 | 176 | (5) |
Foreign currency translation adjustments | 340 | (1,314) | (144) | (624) |
Total other comprehensive income (loss) | 448 | (1,297) | 32 | (629) |
Total comprehensive loss | $ (42,265) | $ (40,741) | $ (82,353) | $ (79,031) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit |
Beginning Balances at Dec. 31, 2017 | $ 199,549 | $ 62 | $ 1,107,693 | $ (881) | $ (907,325) |
Beginning Balances (in shares) at Dec. 31, 2017 | 61,533 | ||||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net | (549) | $ 1 | (550) | ||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net (in shares) | 1,017 | ||||
Issuance of common stock under Employee Stock Purchase Plan | 255 | 255 | |||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 58 | ||||
Stock compensation expense | 11,089 | 11,089 | |||
Total other comprehensive income (loss) | (629) | (629) | |||
Net loss | (78,402) | (78,402) | |||
Ending Balances at Jun. 30, 2018 | 131,313 | $ 63 | 1,118,487 | (1,510) | (985,727) |
Ending Balances (in shares) at Jun. 30, 2018 | 62,608 | ||||
Beginning Balances at Mar. 31, 2018 | 165,887 | $ 62 | 1,112,321 | (213) | (946,283) |
Beginning Balances (in shares) at Mar. 31, 2018 | 62,254 | ||||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net | (123) | $ 1 | (124) | ||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net (in shares) | 354 | ||||
Stock compensation expense | 6,290 | 6,290 | |||
Total other comprehensive income (loss) | (1,297) | (1,297) | |||
Net loss | (39,444) | (39,444) | |||
Ending Balances at Jun. 30, 2018 | 131,313 | $ 63 | 1,118,487 | (1,510) | (985,727) |
Ending Balances (in shares) at Jun. 30, 2018 | 62,608 | ||||
Beginning Balances at Dec. 31, 2018 | 63,065 | $ 63 | 1,131,241 | (2,015) | (1,066,224) |
Beginning Balances (in shares) at Dec. 31, 2018 | 62,862 | ||||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net | 1 | 1 | |||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net (in shares) | 831 | ||||
Issuance of common stock under Employee Stock Purchase Plan | 407 | 407 | |||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 75 | ||||
Issuance of common stock, net of issuance costs | 13,949 | $ 2 | 13,947 | ||
Issuance of common stock, net of issuance costs (in shares) | 1,387 | ||||
Stock compensation expense | 15,519 | 15,519 | |||
Total other comprehensive income (loss) | 32 | 32 | |||
Net loss | (82,385) | (82,385) | |||
Ending Balances at Jun. 30, 2019 | 10,588 | $ 65 | 1,161,115 | (1,983) | (1,148,609) |
Ending Balances (in shares) at Jun. 30, 2019 | 65,155 | ||||
Beginning Balances at Mar. 31, 2019 | 43,159 | $ 65 | 1,151,421 | (2,431) | (1,105,896) |
Beginning Balances (in shares) at Mar. 31, 2019 | 65,020 | ||||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net | 19 | 19 | |||
Issuance (withholding) of common stock upon exercise of stock options and restricted stock awards, net (in shares) | 91 | ||||
Issuance of common stock, net of issuance costs | 326 | 326 | |||
Issuance of common stock, net of issuance costs (in shares) | 44 | ||||
Stock compensation expense | 9,349 | 9,349 | |||
Total other comprehensive income (loss) | 448 | 448 | |||
Net loss | (42,713) | (42,713) | |||
Ending Balances at Jun. 30, 2019 | $ 10,588 | $ 65 | $ 1,161,115 | $ (1,983) | $ (1,148,609) |
Ending Balances (in shares) at Jun. 30, 2019 | 65,155 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Operating activities | ||
Net loss | $ (82,385) | $ (78,402) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 3,196 | 1,658 |
Amortization of right-of-use assets | 2,046 | |
Accretion of discounts on marketable securities | (875) | (681) |
Stock compensation expense | 15,519 | 11,089 |
Cost of sales - amortization of intangible assets | 4,570 | 4,715 |
Non-cash interest expense | 2,135 | 1,139 |
Changes in operating assets and liabilities: | ||
Accounts and other receivables, net | (3,878) | (450) |
Inventories, net | (17,607) | (4,800) |
Prepaid expenses and other current assets | (643) | (186) |
Other assets | 3,177 | (834) |
Accounts payable | 2,817 | 1,623 |
Lease liabilities | (761) | |
Accrued liabilities and other liabilities | (3,574) | 1,330 |
Net cash used in operating activities | (76,263) | (63,799) |
Investing activities | ||
Acquisition of technology licenses | (7,000) | (9,500) |
Purchases of marketable securities | (108,341) | (186,821) |
Proceeds from maturities of marketable securities | 99,310 | 165,450 |
Purchases of property and equipment, net | (11,383) | (1,639) |
Net cash used in investing activities | (27,414) | (32,510) |
Financing activities | ||
Proceeds from long-term debt, net | 74,250 | 99,000 |
Proceeds from issuance of common stock, net | 13,949 | |
Proceeds (tax withholding) from exercise of stock options and restricted stock awards, net | 1 | (549) |
Proceeds from Employee Stock Purchase Plan | 407 | 255 |
Net cash provided by financing activities | 88,607 | 98,706 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (44) | (260) |
Net (decrease) increase in cash, cash equivalents and restricted cash | (15,114) | 2,137 |
Cash, cash equivalents and restricted cash at beginning of period | 49,967 | 27,213 |
Cash, cash equivalents and restricted cash at end of period | 34,853 | 29,350 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | 5,300 | 2,713 |
Tenant improvements provided by the landlord | 3,228 | |
Non-cash investing and financing activities: | ||
Disposal of fully depreciated property and equipment | 981 | 42 |
Non-cash acquisition of technology license | 12,773 | |
Purchases of property and equipment, not yet paid | 6,920 | $ 327 |
Right-of-use assets obtained in exchange for operating lease liabilities | $ 34,807 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Dynavax Technologies Corporation (“we,” “our,” “us,” “Dynavax” or the “Company”), is a fully-integrated biopharmaceutical company focused on leveraging the power of the body’s innate and adaptive immune responses through toll-like receptor (“TLR”) stimulation. We discover, develop and commercialize novel vaccines. We launched our first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018, following United States Food and Drug Administration (“FDA”) approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. We were incorporated in California in August 1996 under the name Double Helix Corporation, and we changed our name to Dynavax Technologies Corporation in September 1996. We reincorporated in Delaware in 2000. On May 23, 2019, we implemented a strategic organizational restructuring, to principally align our operations around our vaccine business and significantly curtail further investment in our immuno-oncology business. In connection with the restructuring, we reduced our workforce by approximately 80 positions, or approximately 36%, of U.S.-based personnel. Also in connection with the restructuring, our Chief Executive Officer, also a member of the Board of Directors (the “Board”), submitted notice of his retirement from the Company and the Board, effective August 1, 2019. We expect the restructuring to be substantially complete and the costs incurred and paid by December 31, 2019. We are exploring strategic alternatives for our immuno-oncology business. Basis of Presentation Our accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. In our opinion, these unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which we consider necessary to present fairly our financial position and the results of our operations and cash flows. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted. Interim-period results are not necessarily indicative of results of operations or cash flows to be expected for a full-year period or any other interim-period. The condensed consolidated balance sheet at December 31, 2018 has been derived from audited financial statements at that date, but excludes disclosures required by GAAP for complete financial statements. The unaudited condensed consolidated financial statements and these notes should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2018, as filed with the Securities and Exchange Commission (the “SEC”). The unaudited condensed consolidated financial statements include the accounts of Dynavax and our wholly-owned subsidiary, Dynavax GmbH. All significant intercompany accounts and transactions among these entities have been eliminated from the condensed consolidated financial statements. We operate in one business segment: discovery, development and commercialization of novel vaccines. Liquidity and Financial Condition As of June 30, 2019, we had cash, cash equivalents and marketable securities of $140.5 million. The Company has incurred losses and negative cash flows from operations since its inception and expects to incur operating losses for the foreseeable future as we continue to invest in commercialization of HEPLISAV-B. The Company believes that its cash, cash equivalents and marketable securities of $140.5 million at June 30, 2019 and expected revenues and funds from operations will be sufficient to allow the Company to fund its current operations through the first quarter of 2020. Until we can generate a sufficient amount of revenue from product sales, we will need to finance our operations through strategic alliance and licensing arrangements and/or future public or private debt and equity financings. Adequate financing may not be available to us on acceptable terms, or at all. In the absence of additional financing, these conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. If adequate funds are not available when needed, we may need to significantly reduce our operations while we seek strategic alternatives, which could have an adverse impact on our ability to achieve our intended business objectives. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our ability to raise additional capital in the equity and debt markets, should we choose to do so, is dependent on a number of factors, including, but not limited to, the market demand for our common stock, which itself is subject to a number of development and business risks and uncertainties, our creditworthiness and the uncertainty that we would be able to raise such additional capital at a price or on terms that are favorable to us. Raising additional funds through the issuance of equity or debt securities could result in dilution to our existing stockholders, increased fixed payment obligations, or both. In addition, these securities may have rights senior to those of our common stock and could include covenants that would restrict our operations . Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Management’s estimates are based on historical information available as of the date of the condensed consolidated financial statements and various other assumptions we believe are reasonable under the circumstances. Actual results could differ materially from these estimates. Summary of Significant Accounting Policies Revenue Recognition We recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of Accounting Standards Codification (“ASC”) 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Revenue, Net We sell our product to a limited number of wholesalers and specialty distributors in the U.S. (collectively, our “Customers”). Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product upon delivery to the Customer. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Because our standard credit terms are short-term and we expect to receive payment in less than one-year, there is no financing component on the related receivables. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as product returns, chargebacks, discounts, rebates and other fees that are offered within contracts between us and our Customers, healthcare providers, and others relating to our product sales. We estimate variable consideration using either the most likely amount method or the expected value method, depending on the type of variable consideration and what method better predicts the amount of consideration we expect to receive. We take into consideration relevant factors such as industry data, current contractual terms, available information about Customers’ inventory, resale and chargeback data and forecasted customer buying and payment patterns, in estimating each variable consideration. The variable consideration is recorded at the time product sales is recognized, resulting in a reduction in product revenue and a reduction in accounts receivable (if the Customer offsets the amount against its accounts receivable) or as an accrued liability (if we pay the amount through our accounts payable process). Variable consideration requires significant estimates, judgment and information obtained from external sources. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. If we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of revenue that we report in a particular period. There have been no material adjustments to these estimates for the six months ended June 30, 2019. Product Returns: Consistent with industry practice, we offer our Customers a limited right of return based on the product’s expiration date for product th at has been purchased from us. We estimate the amount of our product sales that may be returned by our Customers and record this estimate as a reduction of revenue in the period the related product reven ue is recognized. We consider several factors in the estimation of potential product returns including expiration dates of the product shipped, the limited product return rights, available information about Customers’ inventory , shelf life of the product and other relevant factors. Chargebacks: Our Customers subsequently resell our product to healthcare providers. In addition to distribution agreements with Customers, we enter into arrangements with healthcare providers that provide for chargebacks and discounts with respect to the purchase of our product. Chargebacks represent the estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are determined at the time of resale to the qualified healthcare provider by Customers, and we issue credits for such amounts generally within a few weeks of the Customer’s notification to us of the resale. Reserves for chargebacks consists of credits that we expect to issue for units that remain in the distribution channel inventories at each reporting period end that we expect will be sold to qualified healthcare providers, and chargebacks for units that our Customers have sold to healthcare providers, but for which credits have not been issued. Trade Discounts and Allowances: We provide our Customers with discounts which include early payment incentives that are explicitly stated in our contracts, and are recorded as a reduction of revenue in the period the related product revenue is recognized. Distribution Fees: Distribution fees include fees paid to certain Customers for sales order management, data and distribution services. Distribution fees are recorded as a reduction of revenue in the period the related product revenue is recognized. Collaboration Revenue We enter into collaborative arrangements with other companies. Such arrangements may include promises to customers which, if capable of being distinct, are accounted for as separate performance obligations. For agreements with multiple performance obligations, we allocate estimated revenue to each performance obligation at contract inception based on the estimated transaction price of each performance obligation. Revenue allocated to each performance obligation is then recognized when we satisfy the performance obligation by transferring control of the promised good or service to the customer. Leases On January 1, 2019, we adopted ASC 842, Leases, using the modified retrospective approach. Prior period amounts continue to be reported in accordance with our historic accounting under previous lease guidance, ASC 840, Leases. We elected the package of practical expedients which, among other things, allowed us to carry forward the historical lease classification of leases in place as of January 1, 2019. As a result of adopting ASC 842, we recognized right-of-use asset and lease liabilities for operating leases of $34.8 million and $37.1 million, respectively on January 1, 2019. There was no adjustment to the opening balance of accumulated deficit as a result of the adoption of ASC 842. We determine if an arrangement includes a lease at inception. Operating leases are included in operating lease right-of-use assets, other current liabilities and long-term portion of lease liabilities in our condensed consolidated balance sheets. Right-of-use assets represent our right to use an underlying asset during the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, we use our incremental borrowing rate which represents an estimated rate of interest that we would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The operating lease right-of-use assets also include any lease payments made and exclude any lease incentives. Our leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that we will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term. We have elected not to apply the recognition requirements of ASC 842 for short-term leases. Inventories Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the six months ended June 30, 2019, there was no inventory reserve recognized. We consider regulatory approval of product candidates to be uncertain and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but are expensed as research and development costs. We begin capitalization of these inventory related costs once regulatory approval is obtained. HEPLISAV-B was approved by the FDA on November 9, 2017, at which time we began to capitalize inventory costs associated with HEPLISAV-B. In March 2018, we received regulatory approval of the pre-filled syringe (“PFS”) presentation of HEPLISAV-B. Prior to FDA approval of HEPLISAV-B, all costs related to the manufacturing of HEPLISAV-B that could potentially be available to support the commercial launch of our products, were charged to research and development expense in the period incurred as there was no alternative future use. Prior to regulatory approval of PFS, costs associated with resuming operating activities at the Düsseldorf manufacturing facility were also included in research and development expense. Subsequent to regulatory approval of PFS, costs associated with resuming manufacturing activities at the Düsseldorf facility were included in cost of sales – product, until commercial production resumed in mid-2018 at which time these costs were recorded as raw materials inventory. Research and Development Expenses and Accruals Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed. We contract with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to our vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. Our accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. We may terminate these contracts upon written notice and we are generally only liable for actual effort expended by the organizations to the date of termination, although in certain instances we may be further responsible for termination fees and penalties. We estimate research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to us at that time. There have been no material adjustments to the prior period accrued estimates for clinical trial activities for the six months ended June 30, 2019 . Restructuring Restructuring costs are comprised of severance, other termination benefit costs and stock-based compensation expense for stock award and stock option modifications related to workforce reductions. We recognize restructuring charges when the liability is incurred. Employee termination benefits are accrued at the date management has committed to a plan of termination and affected employees have been notified of their termination date and expected severance benefits. Recent Accounting Pronouncements Accounting Standards Update 2016-13 In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments. The standard changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. In April 2019, the FASB issued targeted clarification to ASU No. 2016-13 within ASU No. 2019-04. In May 2019, the FASB issued targeted transition relief to ASU No. 2016-13 within ASU No. 2019-05. These ASUs are effective for annual periods beginning after December 15, 2019 with early adoption permitted. We are currently evaluating the impact this standard will have on our condensed consolidated financial statements. Accounting Standards Update 2017-04 In January 2017, the FASB issued ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350), which simplifies the test for goodwill impairment by eliminating a previous requirement to calculate the implied fair value of goodwill to measure a goodwill impairment charge. The ASU is effective for annual periods beginning after December 15, 2019 with early adoption permitted. The adoption is not expected to have a material impact on our condensed consolidated financial statements. Accounting Standards Update 2018-13 In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820), that eliminates, adds and modifies certain disclosure requirements of fair value measurements. Entities will no longer be required to disclose the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, but public companies will be required to disclose the range and weighted average used to develop significant unobservable inputs for Level 3 fair value measurements. The ASU is effective for annual periods beginning after December 15, 2019 with early adoption permitted. The adoption of this standard is not expected to have a material impact on our condensed consolidated financial statements. Accounting Standards Update 2018-15 In August 2018, the FASB issued ASU No. 2018-15, Intangibles – Goodwill and Other –Internal-Use Software (Subtopic 350-40). This ASU requires a customer in a cloud computing arrangement (i.e. hosting arrangement) that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to capitalize as assets or expense as incurred. ASC 350-40 requires that certain costs incurred during the application development stage be capitalized and other costs incurred during the preliminary project and post-implementation stages be expensed as incurred. The ASU is effective for annual periods beginning after December 15, 2019 with early adoption permitted. The adoption of this standard is not expected to have a material impact on our condensed consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 2. Fair Value Measurements We measure fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following: • Level 1—Observable inputs, such as quoted prices in active markets for identical assets or liabilities; • Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities; therefore, requiring an entity to develop its own valuation techniques and assumptions. Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. We review the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The carrying amounts of cash equivalents, accounts and other receivables, accounts payable and accrued liabilities are considered reasonable estimates of their respective fair value because of their short-term nature. As of June 30, 2019, we measured the fair value of our $7.0 million payment to Merck Sharpe & Dohme Corp., which is due in the first quarter of 2020, based on Level 3 inputs due to the use of unobservable inputs that cannot be corroborated by observable market data. We estimated the fair value of the liability using a discounted cash flow technique using the effective interest rate on our term loan. The liability had a fair value of $6.6 million as of June 30, 2019. Recurring Fair Value Measurements The following table represents the fair value hierarchy for our financial assets (cash equivalents and marketable securities) measured at fair value on a recurring basis (in thousands): Level 1 Level 2 Level 3 Total June 30, 2019 Money market funds $ 29,343 $ - $ - $ 29,343 U.S. treasuries - 1,994 - 1,994 U.S. government agency securities - 26,903 - 26,903 Corporate debt securities - 79,870 - 79,870 Total $ 29,343 $ 108,767 $ - $ 138,110 Level 1 Level 2 Level 3 Total December 31, 2018 Money market funds $ 44,002 $ - $ - $ 44,002 U.S. treasuries - 14,724 - 14,724 U.S. government agency securities - 42,372 - 42,372 Corporate debt securities - 41,291 - 41,291 Total $ 44,002 $ 98,387 $ - $ 142,389 Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments is readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. U.S. treasuries, U.S. government agency securities and corporate debt securities are measured at fair value using Level 2 inputs. We review trading activity and pricing for these investments as of each measurement date. When sufficient quoted pricing for identical securities is not available, we use market pricing and other observable market inputs for similar securities obtained from various third party data providers. These inputs represent quoted prices for similar assets in active markets or these inputs have been derived from observable market data. This approach results in the classification of these securities as Level 2 of the fair value hierarchy. There were no transfers between Level 1 and Level 2 during the six months ended June 30, 2019. |
Cash, Cash Equivalents, Restric
Cash, Cash Equivalents, Restricted Cash and Marketable Securities | 6 Months Ended |
Jun. 30, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Cash, Cash Equivalents, Restricted Cash and Marketable Securities | 3. Cash, Cash Equivalents, Restricted Cash and Marketable Securities The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheet that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows: June 30, 2019 December 31, 2018 June 30, 2018 December 31, 2017 Cash and cash equivalents $ 34,225 $ 49,348 $ 28,726 $ 26,584 Restricted cash 628 619 624 629 Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows $ 34,853 $ 49,967 $ 29,350 $ 27,213 Restricted cash balances relate to certificates of deposit issued as collateral to certain letters of credit issued as security to our facility leases in Berkeley, California and Düsseldorf, Germany. See Note 6. Cash, cash equivalents and marketable securities consist of the following (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value June 30, 2019 Cash and cash equivalents: Cash $ 2,384 $ - $ - $ 2,384 Money market funds 29,343 - - 29,343 U.S. treasuries 500 - - 500 Corporate debt securities 1,998 - - 1,998 Total cash and cash equivalents 34,225 - - 34,225 Marketable securities available-for-sale: U.S. treasuries 1,493 1 - 1,494 U.S. government agency securities 26,874 29 - 26,903 Corporate debt securities 77,794 78 - 77,872 Total marketable securities available-for-sale 106,161 108 - 106,269 Total cash, cash equivalents and marketable securities $ 140,386 $ 108 $ - $ 140,494 December 31, 2018 Cash and cash equivalents: Cash $ 3,147 $ - $ - $ 3,147 Money market funds 44,002 - - 44,002 Corporate debt securities 2,199 - - 2,199 Total cash and cash equivalents 49,348 - - 49,348 Marketable securities available-for-sale: U.S. treasuries 14,732 - (8 ) 14,724 U.S. government agency securities 42,416 - (44 ) 42,372 Corporate debt securities 39,108 - (16 ) 39,092 Total marketable securities available-for-sale 96,256 - (68 ) 96,188 Total cash, cash equivalents and marketable securities $ 145,604 $ - $ (68 ) $ 145,536 The maturities of our marketable securities available-for-sale are as follows (in thousands): June 30, 2019 Amortized Cost Estimated Fair Value Mature in one year or less $ 106,161 $ 106,269 Mature after one year through two years - - $ 106,161 $ 106,269 There were no realized gains or losses from the sale of marketable securities during the six months ended June 30, 2019 and 2018. We have classified our entire investment portfolio as available-for-sale and available for use in current operations and accordingly have classified all investments as short-term. Available-for-sale securities are carried at fair value based on inputs that are observable, either directly or indirectly, such as quoted market prices for similar securities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the securities, with unrealized gains and losses included in accumulated other comprehensive loss in stockholders’ equity. Realized gains and losses and declines in value, if any, judged to be other than temporary on available-for-sale securities are included in interest income or expense. The cost of securities sold is based on the specific identification method. Management assesses whether declines in the fair value of investment securities are other than temporary. In determining whether a decline is other than temporary, management considers the following factors: • whether the investment has been in a continuous realized loss position for over 12 months; • the duration to maturity of our investments; • our intention and ability to hold the investment to maturity and if it is not more likely than not that we will be required to sell the investment before recovery of the amortized cost bases; • the credit rating, financial condition and near-term prospects of the issuer; and • the type of investments made. To date, there have been no declines in fair value that have been identified as other than temporary. |
Inventories, Net
Inventories, Net | 6 Months Ended |
Jun. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Inventories, net | 4. Inventories, net The following table presents inventories (in thousands): June 30, 2019 December 31, 2018 Raw materials $ 23,155 $ 12,111 Work-in-process 12,182 6,562 Finished goods 1,292 349 Total $ 36,629 $ 19,022 |
Intangible Assets
Intangible Assets | 6 Months Ended |
Jun. 30, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets | 5. Intangible Assets, net Intangible assets are related to certain June 30, 2019 December 31, 2018 Intangible assets $ 19,773 $ 19,773 Less accumulated amortization (12,626 ) (8,056 ) Total $ 7,147 $ 11,717 We recorded $2.3 million of cost of sales - amortization of intangible assets for each of the three months ended June 30, 2019 and 2018. We recorded $4.6 million and $4.7 million as cost of sales - amortization of intangible assets for the six months ended June 30, 2019 and 2018. See Note 7. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies Leases As described in Note 1, we adopted ASC 842 as of January 1, 2019. We evaluated our contracts and have determined that, effective upon the adoption of ASC 842, our operating leases included equipment, office/laboratory and manufacturing facility leases. We lease our facilities in Berkeley, California (“Berkeley Lease”), Emeryville, California and Düsseldorf, Germany. On September 17, 2018, we entered into an Office/Laboratory Lease (“Lease”) for office and laboratory space located at 5959 Horton Street, Emeryville, California (“Premises”). Under the terms of the Lease, we are leasing 75,662 square feet in the Premises (“Rented Area”) at the rate of $4.75 (“Base Rate”) multiplied by the Rented Area, paid on a monthly basis, starting on April 1, 2019 (“Commencement Date”). The Base Rate is subject to scheduled annual increases, and we are also responsible for certain operating expenses and taxes throughout the life of the Lease. In connection with the Lease, we are entitled to a tenant improvement allowance of up to $8.3 million. The Lease has an initial term of 12 years, following the Commencement Date with an option to extend the lease for two successive five-year terms. The optional periods were not included in the lease term used in determining the right-of-use asset or the lease liability as we did not consider it reasonably certain that we would exercise the options. The operating lease right-of-use assets and liabilities on our June 30, 2019 condensed consolidated balance sheets primarily relate to this Lease. In connection with our execution of the Lease, on September 17, 2018, we entered into a Lease Termination Agreement to terminate the Berkeley Lease effective as of the date we vacate the Berkeley premises. See Note 14. Our lease expense comprises of the following (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Operating lease expense $ 1,747 $ 695 $ 3,485 $ 1,391 Cash paid for amounts included in the measurement of lease liabilities for the six months ended June 30, 2019 was $2.4 million and was included in operating cash flows in our condensed consolidated statement of cash flows. The balance sheet classification of our operating lease liabilities was as follows (in thousands): June 30, 2019 December 31, 2018 Operating lease liabilities: Current portion of lease liabilities (included in other current liabilities) $ 1,663 $ - Long-term portion of lease liabilities 34,641 - Total operating lease liabilities $ 36,304 $ - At June 30, 2019, the maturities of our operating lease liabilities were as follows (in thousands): Years ending December 31, 2019 (remaining) $ 2,610 2020 5,324 2021 5,220 2022 5,260 2023 4,952 Thereafter 39,523 Total lease payments 62,889 Less: Present value adjustment (26,585 ) Total operating lease liabilities $ 36,304 As of June 30, 2019, the weighted average remaining lease term is 11.1 years and the weighted average discount rate used to determine the operating lease liability was 10.1%. Commitments In February 2018, we entered into a $175.0 million term loan agreement. Borrowings under the term loan agreement in the amount of $178.2 million , which includes paid-in-kind interest, In February 2018, we entered into a sublicense agreement with Merck Sharpe & Dohme Corp (“Merck”). Under the agreement, we are required to make a payment of $7.0 million in the first quarter of 2020. See Note 7. We have entered into material purchase commitments with commercial manufacturers for the supply of HEPLISAV-B. As of June 30, 2019, our non-cancelable purchase commitments totaled $12.5 million. We rely on and have entered into agreements with research institutions, contract research organizations and clinical investigators. These agreements are terminable by us upon written notice. Generally, we are liable only for actual effort expended by the organizations at any point in time during the contract through the notice period. Contingencies From time to time, we may be involved in claims, suits, and proceedings arising from the ordinary course of our business, including actions with respect to intellectual property claims, commercial claims, and other matters. Such claims, suits, and proceedings are inherently uncertain and their results cannot be predicted with certainty. Regardless of the outcome, such legal proceedings can have an adverse impact on us because of legal costs, diversion of management resources, and other factors. In addition, it is possible that a resolution of one or more such proceedings could result in substantial damages, fines, penalties or orders requiring a change in our business practices, which could in the future materially and adversely affect our financial position, results of operations, or cash flows in a particular period. In conjunction with a financing arrangement with Symphony Dynamo, Inc. and Symphony Dynamo Holdings LLC (“Holdings”) in November 2009, we agreed to make contingent cash payments to Holdings equal to 50% of the first $50 million from any upfront, pre-commercialization milestone or similar payments received by us from any agreement with any third party with respect to the development and/or commercialization of cancer and hepatitis C therapies originally licensed to Symphony Dynamo, Inc., including SD-101. We have made no payments and have not recorded a liability as of June 30, 2019. |
Collaborative Research, Develop
Collaborative Research, Development and License Agreements | 6 Months Ended |
Jun. 30, 2019 | |
Research And Development [Abstract] | |
Collaborative Research, Development and License Agreements | 7. Collaborative Research, Development and License Agreements Serum Institute of India Pvt. Ltd. In June 2017, we entered into an agreement to provide Serum Institute of India Pvt. Ltd. (“SIIPL”) with technical support. In consideration, SIIPL agreed to pay us at an agreed-upon hourly rate for services and reimburse certain out-of-pocket expenses. In addition, we have rights to commercialization of certain potential products manufactured at the SIIPL facility. For the six months ended June 30, 2019, we recognized collaboration revenue of $0.1 million. No collaborative revenue was recognized for the comparative prior period. Merck, Sharp & Dohme Corp. In February 2018, we entered into a Sublicense Agreement (the “Sublicense Agreement”) with Merck. The Sublicense Agreement grants us, under certain non-exclusive U.S. patent rights controlled by Merck which relate to recombinant production of hepatitis B surface antigen, the right to manufacture, use, offer for sale, sell and import HEPLISAV-B in the United States and includes the right to grant further sublicenses. Under the terms of the Sublicense Agreement, we are obligated to pay $21.0 million in three installments. The first and second installment of $7.0 million each was paid in February 2018 and February 2019, respectively and the remaining payment of $7.0 million is due in the first quarter of 2020. The payment in 2020 is classified on the condensed consolidated balance sheets as other current liabilities. At June 30, 2019 and December 31, 2018, the intangible asset, net balance was $7.1 million and $11.7 million, respectively. See Note 5. The Sublicense Agreement continues to be in effect through April 2020, at which time the license becomes perpetual, irrevocable, fully paid-up and royalty free. |
Long-Term Debt
Long-Term Debt | 6 Months Ended |
Jun. 30, 2019 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 8. Long-Term Debt On February 20, 2018, we entered into a $175.0 million term loan agreement (“Loan Agreement”) with CRG Servicing LLC. We initially borrowed $100.0 million (the “Initial Term Loan”) under the Loan Agreement at closing and the remaining $75.0 million (the “Second Tranche Term Loan”) in March 2019 (collectively, “Term Loans”). Net proceeds from the Initial Term Loan and Second Tranche Term Loan were $99.0 million and $74.3 million, respectively. The Term Loans under the Loan Agreement bear interest at a rate equal to 9.5% per annum. At June 30, 2019, the effective interest rate was 10.2%. At our option, until September 30, 2023, a portion of the interest payments may be paid in kind, and thereby added to the principal. Through June 30, 2019, a portion of our interest was paid in kind, which increased the principal amount of the Term Loans to $178.2 million. The Term Loans have a maturity date of December 31, 2023, unless earlier prepaid. The Term Loans and paid-in-kind interest will be entirely payable at maturity. The obligations under the Loan Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a perfected security interest in (i) all tangible and intangible assets of the Company and any future subsidiary guarantors, except for certain customary excluded property, and (ii) all of the capital stock owned by the Company and such future subsidiary guarantors (limited, in the case of the stock of certain non-U.S. subsidiaries of the Company and certain U.S. subsidiaries substantially all of whose assets consist of equity interests in non-U.S. subsidiaries, to 65% of the capital stock of such subsidiaries, subject to certain exceptions). The obligations under the Loan Agreement will be guaranteed by each of the Company’s future direct and indirect subsidiaries (other than certain non-U.S. subsidiaries of the Company and certain U.S. subsidiaries substantially all of whose assets consist of equity interests in non-U.S. subsidiaries, subject to certain exceptions). The Loan Agreement contains customary covenants and requires us to comply with a $15.0 million daily minimum combined cash and investment balance covenant and an annual revenue requirement starting on January 1, 2019 for sales of HEPLISAV-B. The Term Loans may be prepaid by us at any time. If the Term Loans are prepaid prior to the second anniversary of the initial borrowing date, we are subject to a repayment premium of up to 7.0% of the principal amount prepaid, depending on the date of prepayment. We recorded $4.5 million and $2.5 million of interest expense related to the Term Loans during the three months ended June 30, 2019 and 2018, respectively. We recorded $7.1 million and $3.6 million of interest expense related to the Term Loans during the six months ended June 30, 2019 and 2018, respectively. |
Revenue Recognition
Revenue Recognition | 6 Months Ended |
Jun. 30, 2019 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 9. Revenue Recognition All of our product revenue consisted of sales of HEPLISAV-B in the U.S. For the six months ended June 30, 2019 and 2018, our three largest Customers represented approximately 64% and 56% of our product revenue, respectively. The following table summarizes balances and activity in each of the product revenue allowance and reserve categories for the six months ended June 30, 2019 (in thousands): Chargebacks, distribution fees, discounts and other fees Returns Total Balance at December 31, 2018 $ 1,736 $ 569 $ 2,305 Provision related to current period sales 6,418 1,071 7,489 Credit or payments made during the period (4,698 ) (217 ) (4,915 ) Balance at June 30, 2019 $ 3,456 $ 1,423 $ 4,879 Reserves for chargebacks and discounts totaling $2.5 million were recorded as reductions of accounts receivable at June 30, 2019. The remaining reserves balances totaling $2.4 million were recorded as accrued liabilities at June 30, 2019. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding during the period and giving effect to all potentially dilutive common shares using the treasury-stock method. For purposes of this calculation, outstanding options and stock awards are considered to be potentially dilutive common shares and are only included in the calculation of diluted net loss per share when their effect is dilutive. Stock options and stock awards totaling approximately 10,950,000 and 12,978,000 shares of common stock as of June 30, 2019 and 2018, respectively, were excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2019 and 2018, because the effect of their inclusion would have been anti-dilutive. For periods in which we have a net loss and no instruments are determined to be dilutive, such as the three and six months ended June 30, 2019 and 2018, basic and diluted net loss per share are the same. |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2019 | |
Preferred Stock Common Stock And Warrants [Abstract] | |
Common Stock | 11. Common Stock Common Stock Outstanding As of June 30, 2019, there were 65,154,729 shares of our common stock outstanding. On November 3, 2017, we entered into an At Market Sales Agreement (“2017 ATM Agreement”) with Cowen and Company, LLC (“Cowen”) under which we may offer and sell from time to time at our sole discretion, shares of our common stock having an aggregate offering price up to $150 million through Cowen as our sales agent. We pay Cowen a commission of up to 3% of the gross sales proceeds of any common stock sold through Cowen under the 2017 ATM Agreement. For the six months ended June 30, 2019, we received net cash proceeds of $13.9 million resulting from sales of 1,386,906 shares of our common stock. As of June 30, 2019, we have $118.6 million remaining under the 2017 ATM Agreement. |
Equity Plans and Stock-Based Co
Equity Plans and Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2019 | |
Share Based Compensation [Abstract] | |
Equity Plans and Stock-Based Compensation | 12. Equity Plans and Stock-Based Compensation Our 2018 Equity Incentive Plan (the “2018 EIP”) is intended to be the successor to and continuation of the Dynavax Technologies Corporation 2011 Equity Incentive Plan (the “2011 EIP”). The aggregate number of shares of our common stock that may be issued under the 2018 EIP (subject to adjustment for certain changes in capitalization) is comprised of the sum of (i) 5,000,000 newly reserved shares of common stock, (ii) 140,250 unallocated shares of common stock remaining available for grant under the 2011 EIP as of May 31, 2018, and (iii) 7,477,619 shares subject to outstanding stock awards granted under the 2011 EIP and the Dynavax Technologies Corporation 2017 Inducement Award Plan that may become available from time to time as set forth in the 2018 EIP. The 2018 EIP provides for the issuance of up to 12,617,869 shares of our common stock to our employees and directors. On May 30, 2019, our stockholders approved an amendment to 2018 Equity Incentive Plan (the “Amended 2018 EIP”) to, among other things, increase the aggregate number of shares of common stock authorized for issuance by 2,300,000. Under the Amended 2018 EIP, the aggregate number of shares of our common stock that may be issued to employees and directors (subject to adjustment for certain changes in capitalization) is 14,917,869. Option activity under our stock-based compensation plans during the six months ended June 30, 2019 was as follows (in thousands except per share amounts): Shares Underlying Outstanding Options (in thousands) Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Balance at December 31, 2018 5,750 $ 18.20 Options granted 2,925 7.04 Options exercised (10 ) 5.75 Options cancelled: Options forfeited (unvested) (142 ) 13.98 Options expired (vested) (105 ) 17.55 Balance at June 30, 2019 8,418 $ 14.42 5.13 $ 199 Vested and expected to vest at June 30, 2019 7,970 $ 14.75 5.07 $ 173 Exercisable at June 30, 2019 3,893 $ 19.14 4.17 $ - Restricted stock unit activity under our stock-based compensation plans during the six months ended June 30, 2019 was as follows (in thousands except per share amounts): Number of Shares (In thousands) Weighted-Average Grant-Date Fair Value Per Share Non-vested as of December 31, 2018 1,594 $ 8.82 Granted 1,822 8.80 Vested (826 ) 6.79 Forfeited (59 ) 11.74 Non-vested as of June 30, 2019 2,531 $ 9.40 The aggregate intrinsic value of the restricted stock units outstanding as of June 30, 2019, based on our stock price on that date was $10.1 million. Fair value of restricted stock units is determined at the date of grant using our closing stock price. As of June 30, 2019, approximately 151,000 shares underlying stock options and approximately 191,000 restricted stock unit awards with performance-based vesting criteria were outstanding. We recognized stock-based compensation expense for awards with performance-based vesting criteria of $28,000 and $0.3 million for the three and six months ended June 30, 2019, respectively. Under our stock-based compensation plans, option awards generally vest over a three or four-year period contingent upon continuous service, and expire seven to ten years from the date of grant (or earlier upon termination of continuous service). The fair value-based measurement of each option is estimated on the date of grant using the Black-Scholes option valuation model. The fair value-based measurements and weighted-average assumptions used in the calculations of these measurements are as follows: Stock Options Stock Options Employee Stock Purchase Plan Three Months Ended Six Months Ended Six Months Ended June 30, June 30, June 30, 2019 2018 2019 2018 2019 2018 Weighted-average fair value per share $ 4.92 $ 11.37 $ 4.67 $ 11.12 $ 5.19 $ 10.39 Risk-free interest rate 2.3 % 2.7 % 2.2 % 2.6 % 2.5 % 2.1 % Expected life (in years) 4.5 4.5 4.5 4.5 1.2 1.3 Volatility 0.9 0.9 0.9 0.9 0.8 1.1 The components of stock-based compensation expense were (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 1,976 $ 2,674 $ 4,156 $ 4,862 Selling, general and administrative 2,470 2,997 5,550 5,585 Restructuring 4,122 - 4,122 - Cost of sales - product 292 619 630 642 Inventory 489 - 1,061 - Total $ 9,349 $ 6,290 $ 15,519 $ 11,089 Compensation expense is based on awards ultimately expected to vest and reflects estimated forfeitures. Stock-based compensation cost for the three and six months ended June 30, 2019 include incremental cost of $4.1 million for accelerated vesting of stock awards and extension of exercise period of stock options for the retirement of our Chief Executive Officer. See Note 13. As of June 30, 2019, the total unrecognized compensation cost related to non-vested equity awards including all awards with time-based vesting amounted to $35.6 million, which is expected to be recognized over the remaining weighted-average vesting period of 1.9 years. Additionally, as of June 30, 2019, the total unrecognized compensation cost related to equity awards with performance-based vesting criteria amounted to $1.7 million. Employee Stock Purchase Plan The Amended and Restated 2014 Employee Stock Purchase Plan (the “Purchase Plan”) provides for the purchase of common stock by eligible employees and became effective on May 28, 2014. On May 31, 2018, our stockholders approved an amendment to the Purchase Plan to increase the aggregate number of shares of common stock authorized for issuance by 600,000 shares. The purchase price per share is the lesser of (i) 85% of the fair market value of the common stock on the commencement of the offer period (generally, the sixteenth day in February or August) or (ii) 85% of the fair market value of the common stock on the exercise date, which is the last day of a purchase period (generally, the fifteenth day in February or August). For the six months ended June 30, 2019, employees have acquired 74,562 shares of our common stock under the Purchase Plan and 498,472 shares of our common stock remained available for future purchases under the Purchase Plan. |
Restructuring
Restructuring | 6 Months Ended |
Jun. 30, 2019 | |
Restructuring And Related Activities [Abstract] | |
Restructuring | 13. Restructuring On May 23, 2019, we implemented a strategic organizational restructuring, to principally align our operations around our vaccine business and significantly curtail further investment in our immuno-oncology business. In connection with the restructuring, we reduced our workforce by approximately 80 positions, or approximately 36%, of U.S.-based personnel. Also in connection with the restructuring, our Chief Executive Officer, also a member of the Board of Directors (the “Board”), submitted notice of his retirement from the Company and the Board, effective August 1, 2019. We expect the restructuring to be substantially complete and the costs incurred and paid by December 31, 2019. We are exploring strategic alternatives for our immuno-oncology business. The total restructuring cost is estimated to be $9.4 million, of which $5.3 million is related to severance, other termination benefits and outplacement services and $4.1 million is related to stock-based compensation expense as a result of accelerated vesting of stock awards and extension of exercise period of stock options. During the three months ended June 30, 2019, we recognized restructuring charges of $8.8 million and the remaining $0.6 million is expected to be recognized by the end of 2019. The outstanding restructuring liabilities are included in accrued liabilities on the condensed consolidated balance sheets. As of June 30, 2019, the components of the restructuring liabilities were as follows (in thousands): Severance and Other Termination Benefits Balance at December 31, 2018 $ - Restructuring charges (a) 4,655 Cash payments or settlements - Balance at June 30, 2019 $ 4,655 (a) Excludes stock-based compensation expense of $4.1 million |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 14. Subsequent Events In July 2019, we entered into an Office Sublease (the “Powell Street Sublease”) for office space located at 2100 Powell Street, Emeryville, California (the “Powell Street Premises”). The purpose of the Powell Street Sublease is to replace our current leased premises at 2929 Seventh Street, Berkeley, California. We moved our corporate headquarters to the Powell Street Premises on July 29, 2019. Under the terms of the Powell Street Sublease, we are leasing 23,976 square feet in the Powell Street Premises at the rate of $3.90 per square foot, paid on a monthly basis. Rent is subject to scheduled annual increases and we are responsible for certain operating expenses and taxes throughout the life of the Powell Street Sublease. The Powell Street Sublease will continue until June 30, 2022. Also in July 2019, we entered into a Sublease (the “Horton Street Sublease”) to sublease the entire office/laboratory space located at 5959 Horton Street, Emeryville, California (“Horton Street Premises”). We had previously agreed to lease the Horton Street Premises as our new corporate headquarters (“Horton Street Master Lease”). See Note 6. We have not occupied and do not intend to occupy any of the Horton Street Premises. Under the terms of the Horton Street Sublease, we are subleasing all of the Horton Street Premises consisting of 75,662 rentable square feet at the rate of $5.50 per square foot, paid on a monthly basis. Rent is subject to scheduled annual increases and the subtenant is responsible for certain operating expenses and taxes throughout the life of the Horton Street Sublease. The Horton Street Sublease will continue until March 31, 2031, concurrent with the term of our Horton Street Master Lease. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | Basis of Presentation Our accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. In our opinion, these unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which we consider necessary to present fairly our financial position and the results of our operations and cash flows. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP have been condensed or omitted. Interim-period results are not necessarily indicative of results of operations or cash flows to be expected for a full-year period or any other interim-period. The condensed consolidated balance sheet at December 31, 2018 has been derived from audited financial statements at that date, but excludes disclosures required by GAAP for complete financial statements. The unaudited condensed consolidated financial statements and these notes should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2018, as filed with the Securities and Exchange Commission (the “SEC”). The unaudited condensed consolidated financial statements include the accounts of Dynavax and our wholly-owned subsidiary, Dynavax GmbH. All significant intercompany accounts and transactions among these entities have been eliminated from the condensed consolidated financial statements. We operate in one business segment: discovery, development and commercialization of novel vaccines. |
Liquidity and Financial Condition | Liquidity and Financial Condition As of June 30, 2019, we had cash, cash equivalents and marketable securities of $140.5 million. The Company has incurred losses and negative cash flows from operations since its inception and expects to incur operating losses for the foreseeable future as we continue to invest in commercialization of HEPLISAV-B. The Company believes that its cash, cash equivalents and marketable securities of $140.5 million at June 30, 2019 and expected revenues and funds from operations will be sufficient to allow the Company to fund its current operations through the first quarter of 2020. Until we can generate a sufficient amount of revenue from product sales, we will need to finance our operations through strategic alliance and licensing arrangements and/or future public or private debt and equity financings. Adequate financing may not be available to us on acceptable terms, or at all. In the absence of additional financing, these conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. If adequate funds are not available when needed, we may need to significantly reduce our operations while we seek strategic alternatives, which could have an adverse impact on our ability to achieve our intended business objectives. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our ability to raise additional capital in the equity and debt markets, should we choose to do so, is dependent on a number of factors, including, but not limited to, the market demand for our common stock, which itself is subject to a number of development and business risks and uncertainties, our creditworthiness and the uncertainty that we would be able to raise such additional capital at a price or on terms that are favorable to us. Raising additional funds through the issuance of equity or debt securities could result in dilution to our existing stockholders, increased fixed payment obligations, or both. In addition, these securities may have rights senior to those of our common stock and could include covenants that would restrict our operations . |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Management’s estimates are based on historical information available as of the date of the condensed consolidated financial statements and various other assumptions we believe are reasonable under the circumstances. Actual results could differ materially from these estimates. |
Revenue Recognition | Revenue Recognition We recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of Accounting Standards Codification (“ASC”) 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Revenue, Net We sell our product to a limited number of wholesalers and specialty distributors in the U.S. (collectively, our “Customers”). Revenues from product sales are recognized when we have satisfied our performance obligation, which is the transfer of control of our product upon delivery to the Customer. The timing between the recognition of revenue for product sales and the receipt of payment is not significant. Because our standard credit terms are short-term and we expect to receive payment in less than one-year, there is no financing component on the related receivables. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Overall, product revenue, net, reflects our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as product returns, chargebacks, discounts, rebates and other fees that are offered within contracts between us and our Customers, healthcare providers, and others relating to our product sales. We estimate variable consideration using either the most likely amount method or the expected value method, depending on the type of variable consideration and what method better predicts the amount of consideration we expect to receive. We take into consideration relevant factors such as industry data, current contractual terms, available information about Customers’ inventory, resale and chargeback data and forecasted customer buying and payment patterns, in estimating each variable consideration. The variable consideration is recorded at the time product sales is recognized, resulting in a reduction in product revenue and a reduction in accounts receivable (if the Customer offsets the amount against its accounts receivable) or as an accrued liability (if we pay the amount through our accounts payable process). Variable consideration requires significant estimates, judgment and information obtained from external sources. The amount of variable consideration is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. If our estimates differ significantly from actuals, we will record adjustments that would affect product revenue, net in the period of adjustment. If we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of revenue that we report in a particular period. There have been no material adjustments to these estimates for the six months ended June 30, 2019. Product Returns: Consistent with industry practice, we offer our Customers a limited right of return based on the product’s expiration date for product th at has been purchased from us. We estimate the amount of our product sales that may be returned by our Customers and record this estimate as a reduction of revenue in the period the related product reven ue is recognized. We consider several factors in the estimation of potential product returns including expiration dates of the product shipped, the limited product return rights, available information about Customers’ inventory , shelf life of the product and other relevant factors. Chargebacks: Our Customers subsequently resell our product to healthcare providers. In addition to distribution agreements with Customers, we enter into arrangements with healthcare providers that provide for chargebacks and discounts with respect to the purchase of our product. Chargebacks represent the estimated obligations resulting from contractual commitments to sell product to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargeback amounts are determined at the time of resale to the qualified healthcare provider by Customers, and we issue credits for such amounts generally within a few weeks of the Customer’s notification to us of the resale. Reserves for chargebacks consists of credits that we expect to issue for units that remain in the distribution channel inventories at each reporting period end that we expect will be sold to qualified healthcare providers, and chargebacks for units that our Customers have sold to healthcare providers, but for which credits have not been issued. Trade Discounts and Allowances: We provide our Customers with discounts which include early payment incentives that are explicitly stated in our contracts, and are recorded as a reduction of revenue in the period the related product revenue is recognized. Distribution Fees: Distribution fees include fees paid to certain Customers for sales order management, data and distribution services. Distribution fees are recorded as a reduction of revenue in the period the related product revenue is recognized. Collaboration Revenue We enter into collaborative arrangements with other companies. Such arrangements may include promises to customers which, if capable of being distinct, are accounted for as separate performance obligations. For agreements with multiple performance obligations, we allocate estimated revenue to each performance obligation at contract inception based on the estimated transaction price of each performance obligation. Revenue allocated to each performance obligation is then recognized when we satisfy the performance obligation by transferring control of the promised good or service to the customer. |
Leases | Leases On January 1, 2019, we adopted ASC 842, Leases, using the modified retrospective approach. Prior period amounts continue to be reported in accordance with our historic accounting under previous lease guidance, ASC 840, Leases. We elected the package of practical expedients which, among other things, allowed us to carry forward the historical lease classification of leases in place as of January 1, 2019. As a result of adopting ASC 842, we recognized right-of-use asset and lease liabilities for operating leases of $34.8 million and $37.1 million, respectively on January 1, 2019. There was no adjustment to the opening balance of accumulated deficit as a result of the adoption of ASC 842. We determine if an arrangement includes a lease at inception. Operating leases are included in operating lease right-of-use assets, other current liabilities and long-term portion of lease liabilities in our condensed consolidated balance sheets. Right-of-use assets represent our right to use an underlying asset during the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, we use our incremental borrowing rate which represents an estimated rate of interest that we would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. The operating lease right-of-use assets also include any lease payments made and exclude any lease incentives. Our leases may include options to extend or terminate the lease which are included in the lease term when it is reasonably certain that we will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term. We have elected not to apply the recognition requirements of ASC 842 for short-term leases. |
Inventories | Inventories Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We primarily use actual costs to determine our cost basis for inventories. Our assessment of market value requires the use of estimates regarding the net realizable value of our inventory balances, including an assessment of excess or obsolete inventory. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for our products, product expiration dates and current sales levels. Our assumptions of future demand for our products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. For the six months ended June 30, 2019, there was no inventory reserve recognized. We consider regulatory approval of product candidates to be uncertain and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but are expensed as research and development costs. We begin capitalization of these inventory related costs once regulatory approval is obtained. HEPLISAV-B was approved by the FDA on November 9, 2017, at which time we began to capitalize inventory costs associated with HEPLISAV-B. In March 2018, we received regulatory approval of the pre-filled syringe (“PFS”) presentation of HEPLISAV-B. Prior to FDA approval of HEPLISAV-B, all costs related to the manufacturing of HEPLISAV-B that could potentially be available to support the commercial launch of our products, were charged to research and development expense in the period incurred as there was no alternative future use. Prior to regulatory approval of PFS, costs associated with resuming operating activities at the Düsseldorf manufacturing facility were also included in research and development expense. Subsequent to regulatory approval of PFS, costs associated with resuming manufacturing activities at the Düsseldorf facility were included in cost of sales – product, until commercial production resumed in mid-2018 at which time these costs were recorded as raw materials inventory. |
Research and Development Expenses and Accruals | Research and Development Expenses and Accruals Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed. We contract with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to our vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. Our accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. We may terminate these contracts upon written notice and we are generally only liable for actual effort expended by the organizations to the date of termination, although in certain instances we may be further responsible for termination fees and penalties. We estimate research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to us at that time. There have been no material adjustments to the prior period accrued estimates for clinical trial activities for the six months ended June 30, 2019 . |
Restructuring | Restructuring Restructuring costs are comprised of severance, other termination benefit costs and stock-based compensation expense for stock award and stock option modifications related to workforce reductions. We recognize restructuring charges when the liability is incurred. Employee termination benefits are accrued at the date management has committed to a plan of termination and affected employees have been notified of their termination date and expected severance benefits. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Standards Update 2016-13 In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments. The standard changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. In April 2019, the FASB issued targeted clarification to ASU No. 2016-13 within ASU No. 2019-04. In May 2019, the FASB issued targeted transition relief to ASU No. 2016-13 within ASU No. 2019-05. These ASUs are effective for annual periods beginning after December 15, 2019 with early adoption permitted. We are currently evaluating the impact this standard will have on our condensed consolidated financial statements. Accounting Standards Update 2017-04 In January 2017, the FASB issued ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350), which simplifies the test for goodwill impairment by eliminating a previous requirement to calculate the implied fair value of goodwill to measure a goodwill impairment charge. The ASU is effective for annual periods beginning after December 15, 2019 with early adoption permitted. The adoption is not expected to have a material impact on our condensed consolidated financial statements. Accounting Standards Update 2018-13 In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820), that eliminates, adds and modifies certain disclosure requirements of fair value measurements. Entities will no longer be required to disclose the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, but public companies will be required to disclose the range and weighted average used to develop significant unobservable inputs for Level 3 fair value measurements. The ASU is effective for annual periods beginning after December 15, 2019 with early adoption permitted. The adoption of this standard is not expected to have a material impact on our condensed consolidated financial statements. Accounting Standards Update 2018-15 In August 2018, the FASB issued ASU No. 2018-15, Intangibles – Goodwill and Other –Internal-Use Software (Subtopic 350-40). This ASU requires a customer in a cloud computing arrangement (i.e. hosting arrangement) that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to capitalize as assets or expense as incurred. ASC 350-40 requires that certain costs incurred during the application development stage be capitalized and other costs incurred during the preliminary project and post-implementation stages be expensed as incurred. The ASU is effective for annual periods beginning after December 15, 2019 with early adoption permitted. The adoption of this standard is not expected to have a material impact on our condensed consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Hierarchy for Financial Assets Measured at Fair Value on Recurring Basis | The following table represents the fair value hierarchy for our financial assets (cash equivalents and marketable securities) measured at fair value on a recurring basis (in thousands): Level 1 Level 2 Level 3 Total June 30, 2019 Money market funds $ 29,343 $ - $ - $ 29,343 U.S. treasuries - 1,994 - 1,994 U.S. government agency securities - 26,903 - 26,903 Corporate debt securities - 79,870 - 79,870 Total $ 29,343 $ 108,767 $ - $ 138,110 Level 1 Level 2 Level 3 Total December 31, 2018 Money market funds $ 44,002 $ - $ - $ 44,002 U.S. treasuries - 14,724 - 14,724 U.S. government agency securities - 42,372 - 42,372 Corporate debt securities - 41,291 - 41,291 Total $ 44,002 $ 98,387 $ - $ 142,389 |
Cash, Cash Equivalents, Restr_2
Cash, Cash Equivalents, Restricted Cash and Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Cash Cash Equivalents And Short Term Investments [Abstract] | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheet that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows: June 30, 2019 December 31, 2018 June 30, 2018 December 31, 2017 Cash and cash equivalents $ 34,225 $ 49,348 $ 28,726 $ 26,584 Restricted cash 628 619 624 629 Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows $ 34,853 $ 49,967 $ 29,350 $ 27,213 |
Summary of Cash, Cash Equivalents and Marketable Securities | Cash, cash equivalents and marketable securities consist of the following (in thousands): Amortized Cost Unrealized Gains Unrealized Losses Estimated Fair Value June 30, 2019 Cash and cash equivalents: Cash $ 2,384 $ - $ - $ 2,384 Money market funds 29,343 - - 29,343 U.S. treasuries 500 - - 500 Corporate debt securities 1,998 - - 1,998 Total cash and cash equivalents 34,225 - - 34,225 Marketable securities available-for-sale: U.S. treasuries 1,493 1 - 1,494 U.S. government agency securities 26,874 29 - 26,903 Corporate debt securities 77,794 78 - 77,872 Total marketable securities available-for-sale 106,161 108 - 106,269 Total cash, cash equivalents and marketable securities $ 140,386 $ 108 $ - $ 140,494 December 31, 2018 Cash and cash equivalents: Cash $ 3,147 $ - $ - $ 3,147 Money market funds 44,002 - - 44,002 Corporate debt securities 2,199 - - 2,199 Total cash and cash equivalents 49,348 - - 49,348 Marketable securities available-for-sale: U.S. treasuries 14,732 - (8 ) 14,724 U.S. government agency securities 42,416 - (44 ) 42,372 Corporate debt securities 39,108 - (16 ) 39,092 Total marketable securities available-for-sale 96,256 - (68 ) 96,188 Total cash, cash equivalents and marketable securities $ 145,604 $ - $ (68 ) $ 145,536 |
Maturities of Marketable Securities Available-for-Sale | The maturities of our marketable securities available-for-sale are as follows (in thousands): June 30, 2019 Amortized Cost Estimated Fair Value Mature in one year or less $ 106,161 $ 106,269 Mature after one year through two years - - $ 106,161 $ 106,269 |
Inventories, Net (Tables)
Inventories, Net (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | The following table presents inventories (in thousands): June 30, 2019 December 31, 2018 Raw materials $ 23,155 $ 12,111 Work-in-process 12,182 6,562 Finished goods 1,292 349 Total $ 36,629 $ 19,022 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Summary of Intangible Assets | Intangible assets are related to certain June 30, 2019 December 31, 2018 Intangible assets $ 19,773 $ 19,773 Less accumulated amortization (12,626 ) (8,056 ) Total $ 7,147 $ 11,717 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Operating Lease Expense | Our lease expense comprises of the following (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2019 2018 2019 2018 Operating lease expense $ 1,747 $ 695 $ 3,485 $ 1,391 |
Summary of Balance Sheet Classification of Operating Lease Liabilities | The balance sheet classification of our operating lease liabilities was as follows (in thousands): June 30, 2019 December 31, 2018 Operating lease liabilities: Current portion of lease liabilities (included in other current liabilities) $ 1,663 $ - Long-term portion of lease liabilities 34,641 - Total operating lease liabilities $ 36,304 $ - |
Summary of Maturities of Operating Lease Liabilities | At June 30, 2019, the maturities of our operating lease liabilities were as follows (in thousands): Years ending December 31, 2019 (remaining) $ 2,610 2020 5,324 2021 5,220 2022 5,260 2023 4,952 Thereafter 39,523 Total lease payments 62,889 Less: Present value adjustment (26,585 ) Total operating lease liabilities $ 36,304 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Revenue Recognition [Abstract] | |
Summary of Product Revenue Allowance and Reserve Categories | The following table summarizes balances and activity in each of the product revenue allowance and reserve categories for the six months ended June 30, 2019 (in thousands): Chargebacks, distribution fees, discounts and other fees Returns Total Balance at December 31, 2018 $ 1,736 $ 569 $ 2,305 Provision related to current period sales 6,418 1,071 7,489 Credit or payments made during the period (4,698 ) (217 ) (4,915 ) Balance at June 30, 2019 $ 3,456 $ 1,423 $ 4,879 |
Equity Plans and Stock-Based _2
Equity Plans and Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Share Based Compensation [Abstract] | |
Option Activity under Stock-Based Compensation Plans | Option activity under our stock-based compensation plans during the six months ended June 30, 2019 was as follows (in thousands except per share amounts): Shares Underlying Outstanding Options (in thousands) Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term (years) Aggregate Intrinsic Value (in thousands) Balance at December 31, 2018 5,750 $ 18.20 Options granted 2,925 7.04 Options exercised (10 ) 5.75 Options cancelled: Options forfeited (unvested) (142 ) 13.98 Options expired (vested) (105 ) 17.55 Balance at June 30, 2019 8,418 $ 14.42 5.13 $ 199 Vested and expected to vest at June 30, 2019 7,970 $ 14.75 5.07 $ 173 Exercisable at June 30, 2019 3,893 $ 19.14 4.17 $ - |
Summary of Restricted Stock Units Activity | Restricted stock unit activity under our stock-based compensation plans during the six months ended June 30, 2019 was as follows (in thousands except per share amounts): Number of Shares (In thousands) Weighted-Average Grant-Date Fair Value Per Share Non-vested as of December 31, 2018 1,594 $ 8.82 Granted 1,822 8.80 Vested (826 ) 6.79 Forfeited (59 ) 11.74 Non-vested as of June 30, 2019 2,531 $ 9.40 |
Fair Value-Based Measurements and Weighted-Average Assumptions | The fair value-based measurements and weighted-average assumptions used in the calculations of these measurements are as follows: Stock Options Stock Options Employee Stock Purchase Plan Three Months Ended Six Months Ended Six Months Ended June 30, June 30, June 30, 2019 2018 2019 2018 2019 2018 Weighted-average fair value per share $ 4.92 $ 11.37 $ 4.67 $ 11.12 $ 5.19 $ 10.39 Risk-free interest rate 2.3 % 2.7 % 2.2 % 2.6 % 2.5 % 2.1 % Expected life (in years) 4.5 4.5 4.5 4.5 1.2 1.3 Volatility 0.9 0.9 0.9 0.9 0.8 1.1 |
Stock-Based Compensation Expense | The components of stock-based compensation expense were (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 1,976 $ 2,674 $ 4,156 $ 4,862 Selling, general and administrative 2,470 2,997 5,550 5,585 Restructuring 4,122 - 4,122 - Cost of sales - product 292 619 630 642 Inventory 489 - 1,061 - Total $ 9,349 $ 6,290 $ 15,519 $ 11,089 |
Restructuring (Tables)
Restructuring (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Restructuring And Related Activities [Abstract] | |
Schedule of Components of the Restructuring Liabilities | The outstanding restructuring liabilities are included in accrued liabilities on the condensed consolidated balance sheets. As of June 30, 2019, the components of the restructuring liabilities were as follows (in thousands): Severance and Other Termination Benefits Balance at December 31, 2018 $ - Restructuring charges (a) 4,655 Cash payments or settlements - Balance at June 30, 2019 $ 4,655 (a) Excludes stock-based compensation expense of $4.1 million |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) | May 23, 2019Position | Feb. 20, 2018USD ($) | Feb. 28, 2018USD ($) | Jun. 30, 2019USD ($)Segment | Mar. 29, 2019USD ($) | Jan. 01, 2019USD ($) |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Number of positions reduced in global workforce | Position | 80 | |||||
Percentage of reduction in global workforce | 36.00% | |||||
Restructuring completion date | Dec. 31, 2019 | |||||
Number of operating segment | Segment | 1 | |||||
Cash, cash equivalents and marketable securities | $ 140,500,000 | |||||
Principal amount including interest paid in kind | $ 178,200,000 | $ 178,200,000 | ||||
Debt maturity date | Dec. 31, 2023 | Dec. 31, 2023 | ||||
Right-of-use asset | $ 29,533,000 | |||||
Operating lease, liability | 36,304,000 | |||||
Inventory reserve | $ 0 | |||||
ASC 842 | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Right-of-use asset | $ 34,800,000 | |||||
Operating lease, liability | $ 37,100,000 | |||||
Maximum | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Expected period of payment to be received | 1 year | |||||
CRG Servicing LLC | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Loan borrowed | $ 100,000,000 | $ 75,000,000 | $ 75,000,000 | |||
Principal amount including interest paid in kind | $ 178,200,000 | |||||
Debt maturity date | Dec. 31, 2023 | |||||
HEPLISAV-B? | ||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | ||||||
Minimum age approved for vaccine prevention of infection caused | 18 years |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Other current liabilities | $ 8,296,000 | $ 7,000,000 |
Transfers from level 1 to level 2 | 0 | |
Transfers from level 2 to level 1 | 0 | |
Merck, Sharp & Dohme Corp. | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Other current liabilities | 7,000,000 | |
Merck, Sharp & Dohme Corp. | Fair Value, Inputs, Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Other current liabilities | $ 6,600,000 |
Fair Value Hierarchy for Financ
Fair Value Hierarchy for Financial Assets Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | $ 138,110 | $ 142,389 |
Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 29,343 | 44,002 |
U.S. Treasuries | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 1,994 | 14,724 |
U.S. Government Agency Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 26,903 | 42,372 |
Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 79,870 | 41,291 |
Fair Value, Inputs, Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 29,343 | 44,002 |
Fair Value, Inputs, Level 1 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 29,343 | 44,002 |
Fair Value, Inputs, Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 108,767 | 98,387 |
Fair Value, Inputs, Level 2 | U.S. Treasuries | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 1,994 | 14,724 |
Fair Value, Inputs, Level 2 | U.S. Government Agency Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | 26,903 | 42,372 |
Fair Value, Inputs, Level 2 | Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets | $ 79,870 | $ 41,291 |
Reconciliation of Cash, Cash Eq
Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2017 |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 34,225 | $ 49,348 | $ 28,726 | $ 26,584 |
Restricted cash | 628 | 619 | 624 | 629 |
Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows | $ 34,853 | $ 49,967 | $ 29,350 | $ 27,213 |
Summary of Cash, Cash Equivalen
Summary of Cash, Cash Equivalents and Marketable Securities (Detail) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | $ 140,386 | $ 145,604 |
Unrealized Gains | 108 | |
Unrealized Losses | (68) | |
Estimated Fair Value | 140,494 | 145,536 |
Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 34,225 | 49,348 |
Estimated Fair Value | 34,225 | 49,348 |
Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 106,161 | 96,256 |
Unrealized Gains | 108 | |
Unrealized Losses | (68) | |
Estimated Fair Value | 106,269 | 96,188 |
Cash | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 2,384 | 3,147 |
Estimated Fair Value | 2,384 | 3,147 |
Money Market Funds | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 29,343 | 44,002 |
Estimated Fair Value | 29,343 | 44,002 |
U.S. Treasuries | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 500 | |
Estimated Fair Value | 500 | |
U.S. Treasuries | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 1,493 | 14,732 |
Unrealized Gains | 1 | |
Unrealized Losses | (8) | |
Estimated Fair Value | 1,494 | 14,724 |
Corporate Debt Securities | Cash and Cash Equivalents | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 1,998 | 2,199 |
Estimated Fair Value | 1,998 | 2,199 |
Corporate Debt Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 77,794 | 39,108 |
Unrealized Gains | 78 | |
Unrealized Losses | (16) | |
Estimated Fair Value | 77,872 | 39,092 |
U.S. Government Agency Securities | Marketable Securities Available-for-Sale | ||
Cash Cash Equivalents And Marketable Securities [Line Items] | ||
Amortized Cost | 26,874 | 42,416 |
Unrealized Gains | 29 | |
Unrealized Losses | (44) | |
Estimated Fair Value | $ 26,903 | $ 42,372 |
Maturities of Marketable Securi
Maturities of Marketable Securities Available-for-Sale (Detail) $ in Thousands | Jun. 30, 2019USD ($) |
Amortized Cost | |
Mature in one year or less | $ 106,161 |
Mature after one year through two years | 0 |
Total amortized cost | 106,161 |
Estimated Fair Value | |
Mature in one year or less | 106,269 |
Mature after one year through two years | 0 |
Total estimated fair value | $ 106,269 |
Cash, Cash Equivalents, Restr_3
Cash, Cash Equivalents, Restricted Cash and Marketable Securities - Additional Information (Detail) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Investments Debt And Equity Securities [Abstract] | ||
Realized gains or losses from the sale of marketable securities | $ 0 | $ 0 |
Summary of Inventories (Detail)
Summary of Inventories (Detail) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 23,155 | $ 12,111 |
Work-in-process | 12,182 | 6,562 |
Finished goods | 1,292 | 349 |
Total | $ 36,629 | $ 19,022 |
Intangible Assets, Net - Summar
Intangible Assets, Net - Summary of Intangible Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Finite Lived Intangible Assets Net [Abstract] | ||
Intangible assets | $ 19,773 | $ 19,773 |
Less accumulated amortization | (12,626) | (8,056) |
Total | $ 7,147 | $ 11,717 |
Intangible Assets, Net - Additi
Intangible Assets, Net - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Finite Lived Intangible Assets Net [Abstract] | ||||
Cost of sales - amortization of intangible assets | $ 2,300 | $ 2,300 | $ 4,570 | $ 4,715 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | Sep. 17, 2018USD ($)ft² | Feb. 28, 2019USD ($) | Feb. 28, 2018USD ($) | Nov. 30, 2009USD ($) | Mar. 31, 2020USD ($) | Jun. 30, 2019USD ($) |
Loss Contingencies [Line Items] | ||||||
Tenant improvement allowance | $ 3,228,000 | |||||
Cash paid for amounts included in the measurement of operating lease liabilities | $ 2,400,000 | |||||
Operating lease, weighted average remaining lease term | 11 years 1 month 6 days | |||||
Operating lease, weighted average discount rate | 10.10% | |||||
Maximum borrowing capacity | $ 175,000,000 | |||||
Principal amount including interest paid in kind | $ 178,200,000 | $ 178,200,000 | ||||
Debt maturity date | Dec. 31, 2023 | Dec. 31, 2023 | ||||
Non-cancelable purchase commitments | $ 12,500,000 | |||||
Symphony Dynamo Holdings LLC | ||||||
Loss Contingencies [Line Items] | ||||||
License arrangement contingent consideration percentage | 50.00% | |||||
License arrangement upfront payment | $ 50,000,000 | |||||
Milestone payments | $ 0 | |||||
Sublicense Agreement | Merck, Sharp & Dohme Corp. | ||||||
Loss Contingencies [Line Items] | ||||||
Payment upon obligation | $ 7,000,000 | $ 7,000,000 | ||||
Scenario, Forecast | Sublicense Agreement | Merck, Sharp & Dohme Corp. | ||||||
Loss Contingencies [Line Items] | ||||||
Payment upon obligation | $ 7,000,000 | |||||
Office and Laboratory Space | Emeryville, California (Premises) | ||||||
Loss Contingencies [Line Items] | ||||||
Lease area | ft² | 75,662 | |||||
Base rent per square feet | $ 4.75 | |||||
Operations commencement date | Apr. 1, 2019 | |||||
Initial lease term | 12 years | |||||
Lease option to extend | The Lease has an initial term of 12 years, following the Commencement Date with an option to extend the lease for two successive five-year terms | |||||
Renewal term of lease | 5 years | |||||
Office and Laboratory Space | Emeryville, California (Premises) | Maximum | ||||||
Loss Contingencies [Line Items] | ||||||
Tenant improvement allowance | $ 8,300,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Operating Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | ||||
Operating lease expense | $ 1,747 | $ 695 | $ 3,485 | $ 1,391 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Balance Sheet Classification of Operating Lease Liabilities (Detail) $ in Thousands | Jun. 30, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
Current portion of lease liabilities (included in other current liabilities) | $ 1,663 |
Long-term portion of lease liabilities | 34,641 |
Total operating lease liabilities | $ 36,304 |
Commitments and Contingencies_4
Commitments and Contingencies - Summary of Maturities of Operating Lease Liabilities (Detail) $ in Thousands | Jun. 30, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2019 (remaining) | $ 2,610 |
2020 | 5,324 |
2021 | 5,220 |
2022 | 5,260 |
2023 | 4,952 |
Thereafter | 39,523 |
Total lease payments | 62,889 |
Present value adjustment | (26,585) |
Total operating lease liabilities | $ 36,304 |
Collaborative Research, Devel_2
Collaborative Research, Development and License Agreements - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Feb. 28, 2019USD ($) | Feb. 28, 2018USD ($)Installment | Mar. 31, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2018USD ($) | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Revenue recognized | $ 8,301,000 | $ 1,254,000 | $ 14,074,000 | $ 1,419,000 | ||||
Intangible assets, net | 7,147,000 | 7,147,000 | $ 11,717,000 | |||||
Collaboration Revenue | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Revenue recognized | 146,000 | |||||||
Serum Institute of India Pvt. Ltd. | Collaboration Revenue | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Revenue recognized | 100,000 | $ 0 | ||||||
Merck, Sharp & Dohme Corp. | Sublicense Agreement | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Aggregate amount payable to acquire intangible assets | $ 21,000,000 | |||||||
Number of installments | Installment | 3 | |||||||
Payment upon obligation | $ 7,000,000 | $ 7,000,000 | ||||||
Intangible assets, net | $ 7,100,000 | $ 7,100,000 | $ 11,700,000 | |||||
Merck, Sharp & Dohme Corp. | Sublicense Agreement | Scenario, Forecast | ||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||||
Payment upon obligation | $ 7,000,000 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Detail) - USD ($) $ in Thousands | Feb. 20, 2018 | Feb. 28, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Mar. 29, 2019 |
Debt Instrument [Line Items] | |||||||
Maximum borrowing capacity | $ 175,000 | ||||||
Net proceeds from the initial term loan | $ 74,250 | $ 99,000 | |||||
Principal amount including interest paid in kind | $ 178,200 | $ 178,200 | $ 178,200 | ||||
Debt maturity date | Dec. 31, 2023 | Dec. 31, 2023 | |||||
Loan Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Percentage of capital stock of subsidiaries subject to certain exception | 65.00% | ||||||
Debt instrument, covenant daily minimum combined cash and investment balance | $ 15,000 | ||||||
Interest expense related to initial term loan | 4,500 | $ 2,500 | $ 7,100 | $ 3,600 | |||
Loan Agreement | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Percentage of repayment premium of principal amount prepaid | 7.00% | ||||||
CRG Servicing LLC | |||||||
Debt Instrument [Line Items] | |||||||
Maximum borrowing capacity | $ 175,000 | ||||||
Current borrowing capacity | $ 100,000 | $ 75,000 | $ 75,000 | $ 75,000 | |||
Debt interest rate | 9.50% | ||||||
Debt instrument interest rate, effective percentage | 10.20% | 10.20% | |||||
Principal amount including interest paid in kind | $ 178,200 | $ 178,200 | |||||
Debt maturity date | Dec. 31, 2023 | ||||||
CRG Servicing LLC | Initial Term Loan | |||||||
Debt Instrument [Line Items] | |||||||
Net proceeds from the initial term loan | $ 99,000 | ||||||
CRG Servicing LLC | Second Tranche | |||||||
Debt Instrument [Line Items] | |||||||
Net proceeds from the initial term loan | $ 74,300 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) - USD ($) $ in Millions | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Product Revenue Allowance and Revenue Categories [Line Items] | ||
Concentration risk, percentage | 64.00% | 56.00% |
Remaining reserves balances recorded as accrued liabilities | $ 2.4 | |
Chargebacks and Discounts | ||
Product Revenue Allowance and Revenue Categories [Line Items] | ||
Reserves recorded as reduction of accounts receivable | $ 2.5 | |
Product | Revenue | Credit Concentration Risk | ||
Product Revenue Allowance and Revenue Categories [Line Items] | ||
Concentration risk, customer | three largest Customers |
Revenue Recognition - Summary o
Revenue Recognition - Summary of Product Revenue Allowance and Reserve Categories (Detail) - HEPLISAV-B® $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Product Revenue Allowance and Revenue Categories [Line Items] | |
Balance at December 31, 2018 | $ 2,305 |
Provision related to current period sales | 7,489 |
Credit or payments made during the period | (4,915) |
Balance at June 30, 2019 | 4,879 |
Chargebacks, distribution fees, discounts and other fees | |
Product Revenue Allowance and Revenue Categories [Line Items] | |
Balance at December 31, 2018 | 1,736 |
Provision related to current period sales | 6,418 |
Credit or payments made during the period | (4,698) |
Balance at June 30, 2019 | 3,456 |
Returns | |
Product Revenue Allowance and Revenue Categories [Line Items] | |
Balance at December 31, 2018 | 569 |
Provision related to current period sales | 1,071 |
Credit or payments made during the period | (217) |
Balance at June 30, 2019 | $ 1,423 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Dilutive securities, effect on basic earnings per share | $ 0 | $ 0 | $ 0 | $ 0 |
Stock Options and Stock Awards | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Outstanding securities excluded from the calculation of diluted net loss per share | 10,950,000 | 12,978,000 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) | Nov. 03, 2017 | Jun. 30, 2019 | Dec. 31, 2018 |
Class Of Stock [Line Items] | |||
Common stock, shares outstanding | 65,154,729 | 62,862,000 | |
Net cash proceeds received | $ 13,949,000 | ||
2017 ATM Agreement | |||
Class Of Stock [Line Items] | |||
Issuance of common stock (in shares) | 1,386,906 | ||
Net cash proceeds received | $ 13,900,000 | ||
Remaining proceeds from common stock, under sales agreement | $ 118,600,000 | ||
Maximum | 2017 ATM Agreement | |||
Class Of Stock [Line Items] | |||
Common stock sales agreement aggregate sales proceeds | $ 150,000,000 | ||
Commission on gross sales proceeds of common stock | 3.00% |
Equity Plans and Stock-Based _3
Equity Plans and Stock-Based Compensation - Additional Information (Detail) - USD ($) | May 30, 2019 | May 28, 2014 | May 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Outstanding stock awards granted | 8,418,000 | 8,418,000 | 5,750,000 | |||||
Increase in aggregate number of shares of common stock authorized for issuance | 600,000 | |||||||
Stock-based compensation expense | $ 9,349,000 | $ 6,290,000 | $ 15,519,000 | $ 11,089,000 | ||||
Restructuring | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | 4,122,000 | 4,122,000 | ||||||
Restricted Stock Units (RSUs) | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Aggregate intrinsic value | $ 10,100,000 | $ 10,100,000 | ||||||
Restricted stock unit awards outstanding | 2,531,000 | 2,531,000 | 1,594,000 | |||||
Employee Stock Option | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Outstanding stock awards granted | 151,000 | 151,000 | ||||||
Employee Stock Option | Minimum | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Options vesting period | 3 years | |||||||
Expiration period | 7 years | |||||||
Employee Stock Option | Maximum | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Options vesting period | 4 years | |||||||
Expiration period | 10 years | |||||||
Performance Based Vesting Condition | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Restricted stock unit awards outstanding | 191,000 | 191,000 | ||||||
Stock-based compensation expense | $ 28,000 | $ 300,000 | ||||||
2018 Equity Incentive Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Newly reserved shares of common stock | 5,000,000 | |||||||
Shares remaining available for future purchases | 140,250 | |||||||
Outstanding stock awards granted | 7,477,619 | |||||||
Shares reserved and approved for issuance | 12,617,869 | 12,617,869 | ||||||
Amended 2018 Equity Incentive Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Increase in aggregate number of shares of common stock authorized for issuance | 2,300,000 | |||||||
Shares reserved and approved for issuance | 14,917,869 | |||||||
Time Based Vesting Schedule | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Total unrecognized compensation cost related to non-vested equity awards | $ 35,600,000 | $ 35,600,000 | ||||||
Total unrecognized compensation cost, weighted-average vesting period | 1 year 10 months 24 days | |||||||
Performance Based Vesting Schedule | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Total unrecognized compensation cost related to non-vested equity awards | $ 1,700,000 | $ 1,700,000 | ||||||
2014 Employee Stock Purchase Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares issued to employees | 74,562 | |||||||
Shares remaining available for future purchases | 498,472 | 498,472 | ||||||
2014 Employee Stock Purchase Plan | The commencement of the offer period (generally, the sixteenth day in February or August) | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Purchase price per share as percentage of fair market value of common stock | 85.00% | |||||||
2014 Employee Stock Purchase Plan | The exercise date, which is the last day of a purchase period (generally, the fifteenth day in February or August) | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Purchase price per share as percentage of fair market value of common stock | 85.00% |
Option Activity under Stock-Bas
Option Activity under Stock-Based Compensation Plans (Detail) $ / shares in Units, shares in Thousands, $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($)$ / sharesshares | |
Shares Underlying Outstanding Options | |
Beginning balance | shares | 5,750 |
Options granted | shares | 2,925 |
Options exercised | shares | (10) |
Ending balance | shares | 8,418 |
Vested and expected to vest at June 30, 2019 | shares | 7,970 |
Exercisable at June 30, 2019 | shares | 3,893 |
Weighted-Average Exercise Price Per Share | |
Beginning balance | $ / shares | $ 18.20 |
Options granted | $ / shares | 7.04 |
Options exercised | $ / shares | 5.75 |
Ending balance | $ / shares | 14.42 |
Vested and expected to vest at June 30, 2019 | $ / shares | 14.75 |
Exercisable at June 30, 2019 | $ / shares | $ 19.14 |
Weighted-Average Remaining Contractual Term (years) | |
Balance at June 30, 2019 | 5 years 1 month 17 days |
Vested and expected to vest at June 30, 2019 | 5 years 25 days |
Exercisable at June 30, 2019 | 4 years 2 months 1 day |
Aggregate Intrinsic Value | |
Balance at June 30, 2019 | $ | $ 199 |
Vested and expected to vest at June 30, 2019 | $ | $ 173 |
Unvested | |
Shares Underlying Outstanding Options | |
Options cancelled | shares | (142) |
Weighted-Average Exercise Price Per Share | |
Options cancelled | $ / shares | $ 13.98 |
Vested | |
Shares Underlying Outstanding Options | |
Options cancelled | shares | (105) |
Weighted-Average Exercise Price Per Share | |
Options cancelled | $ / shares | $ 17.55 |
Summary of Restricted Stock Uni
Summary of Restricted Stock Units Activity (Detail) - Restricted Stock Units (RSUs) shares in Thousands | 6 Months Ended |
Jun. 30, 2019$ / sharesshares | |
Number of Shares | |
Non-vested, Beginning Balance | shares | 1,594 |
Granted | shares | 1,822 |
Vested | shares | (826) |
Forfeited | shares | (59) |
Non-vested, Ending Balance | shares | 2,531 |
Weighted-AverageGrant-Date Fair Value Per Share | |
Non-vested, Beginning Balance | $ / shares | $ 8.82 |
Granted | $ / shares | 8.80 |
Vested | $ / shares | 6.79 |
Forfeited | $ / shares | 11.74 |
Non-vested, Ending Balance | $ / shares | $ 9.40 |
Fair Value-Based Measurements a
Fair Value-Based Measurements and Weighted-Average Assumptions (Detail) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Employee Stock Purchase Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Weighted-average fair value per share | $ 5.19 | $ 10.39 | ||
Risk-free interest rate | 2.50% | 2.10% | ||
Expected life (in years) | 1 year 2 months 12 days | 1 year 3 months 18 days | ||
Volatility | 0.80% | 1.10% | ||
Stock Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Weighted-average fair value per share | $ 4.92 | $ 11.37 | $ 4.67 | $ 11.12 |
Risk-free interest rate | 2.30% | 2.70% | 2.20% | 2.60% |
Expected life (in years) | 4 years 6 months | 4 years 6 months | 4 years 6 months | 4 years 6 months |
Volatility | 0.90% | 0.90% | 0.90% | 0.90% |
Stock-Based Compensation Expens
Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||||
Stock-based compensation expense | $ 9,349 | $ 6,290 | $ 15,519 | $ 11,089 |
Inventory | ||||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||||
Stock-based compensation expense | 489 | 1,061 | ||
Research and Development | ||||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||||
Stock-based compensation expense | 1,976 | 2,674 | 4,156 | 4,862 |
Selling, General and Administrative | ||||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||||
Stock-based compensation expense | 2,470 | 2,997 | 5,550 | 5,585 |
Restructuring | ||||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||||
Stock-based compensation expense | 4,122 | 4,122 | ||
Cost of Sales - Product | ||||
Deferred Compensation Arrangement With Individual Share Based Payments [Line Items] | ||||
Stock-based compensation expense | $ 292 | $ 619 | $ 630 | $ 642 |
Restructuring - Additional Info
Restructuring - Additional Information (Detail) $ in Thousands | May 23, 2019Position | Jun. 30, 2019USD ($) | Jun. 30, 2019USD ($) |
Restructuring Cost And Reserve [Line Items] | |||
Number of positions reduced in global workforce | Position | 80 | ||
Percentage of reduction in global workforce | 36.00% | ||
Restructuring completion date | Dec. 31, 2019 | ||
Estimated restructuring cost | $ 9,400 | $ 9,400 | |
Restructuring charges | 8,777 | 8,777 | |
Estimated restructuring cost remaining | 600 | 600 | |
Employee Severance and Other Benefits | |||
Restructuring Cost And Reserve [Line Items] | |||
Estimated restructuring cost | $ 5,300 | 5,300 | |
Restructuring charges | 4,655 | ||
Stock-Based Compensation Expense | |||
Restructuring Cost And Reserve [Line Items] | |||
Restructuring charges | $ 4,100 |
Restructuring - Schedule of Com
Restructuring - Schedule of Components of the Restructuring Liabilities (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019 | Jun. 30, 2019 | |
Restructuring Cost And Reserve [Line Items] | ||
Restructuring charges | $ 8,777 | $ 8,777 |
Employee Severance and Other Benefits | ||
Restructuring Cost And Reserve [Line Items] | ||
Restructuring charges | 4,655 | |
Balance at June 30, 2019 | $ 4,655 | $ 4,655 |
Restructuring - Schedule of C_2
Restructuring - Schedule of Components of the Restructuring Liabilities (Parenthetical) (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019 | Jun. 30, 2019 | |
Restructuring Cost And Reserve [Line Items] | ||
Restructuring charges | $ 8,777 | $ 8,777 |
Stock-Based Compensation Expense | ||
Restructuring Cost And Reserve [Line Items] | ||
Restructuring charges | $ 4,100 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Emeryville, California (Premises) - Subsequent Event | Jul. 31, 2019USD ($)ft² |
Powell Street Sublease | |
Subsequent Event [Line Items] | |
Lease area | ft² | 23,976 |
Base rent per square feet | $ | $ 3.90 |
Lease expiration date | Jun. 30, 2022 |
Horton Street Sublease | |
Subsequent Event [Line Items] | |
Lease area | ft² | 75,662 |
Base rent per square feet | $ | $ 5.50 |
Lease expiration date | Mar. 31, 2031 |