Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 31, 2019 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | Dermira, Inc. | |
Trading Symbol | DERM | |
Entity Central Index Key | 0001557883 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 54,397,955 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Entity File Number | 001-36668 | |
Entity Tax Identification Number | 273267680 | |
Entity Address, Address Line One | 275 Middlefield Road | |
Entity Address, Address Line Two | Suite 150 | |
Entity Address, City or Town | Menlo Park | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94025 | |
City Area Code | 650 | |
Local Phone Number | 421-7200 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 103,155 | $ 104,976 |
Short-term investments | 222,014 | 208,064 |
Trade and other receivables, net | 59,795 | 5,724 |
Inventory | 17,644 | 8,370 |
Prepaid expenses and other current assets | 25,862 | 8,275 |
Total current assets | 428,470 | 335,409 |
Property and equipment, net | 864 | 1,180 |
Long-term investments | 1,997 | 2,962 |
Operating lease right-of-use asset | 13,144 | |
Intangible assets | 903 | 952 |
Goodwill | 771 | 771 |
Restricted cash | 804 | 802 |
Other assets | 313 | 2,245 |
Total assets | 447,266 | 344,321 |
Current liabilities: | ||
Accounts payable | 11,549 | 15,948 |
Accrued liabilities | 20,029 | 22,608 |
Lease liability, current | 4,220 | |
Deferred revenue, current | 15,075 | |
Total current liabilities | 50,873 | 38,556 |
Long-term liabilities: | ||
Term loan | 32,731 | 32,566 |
Convertible notes, net | 282,145 | 281,223 |
Lease liability, non-current | 9,621 | |
Deferred revenue, non-current | 6,340 | |
Other long-term liabilities | 1,015 | |
Total liabilities | 381,710 | 353,360 |
Stockholders’ equity (deficit): | ||
Common stock | 54 | 42 |
Additional paid-in capital | 893,221 | 736,095 |
Accumulated other comprehensive income (loss) | 113 | (138) |
Accumulated deficit | (827,832) | (745,038) |
Total stockholders’ equity (deficit) | 65,556 | (9,039) |
Total liabilities and stockholders’ equity (deficit) | $ 447,266 | $ 344,321 |
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 | |
Revenue: | ||||
Total revenue | $ 66,645 | $ 39,080 | $ 69,097 | $ 39,379 |
Costs and operating expenses: | ||||
Cost of sales | 1,335 | 2,261 | ||
Research and development | 18,285 | 19,545 | 33,854 | 45,136 |
Selling, general and administrative | 63,327 | 40,770 | 112,006 | 71,280 |
Impairment of intangible assets | 1,126 | |||
Total costs and operating expenses | 82,947 | 60,315 | 148,121 | 117,542 |
Loss from operations | (16,302) | (21,235) | (79,024) | (78,163) |
Interest and other income, net | 1,970 | 2,037 | 3,521 | 3,771 |
Interest expense | (3,630) | (4,734) | (7,291) | (8,988) |
Loss before taxes | (17,962) | (23,932) | (82,794) | (83,380) |
Benefit for income taxes | 194 | |||
Net loss | $ (17,962) | $ (23,932) | $ (82,794) | $ (83,186) |
Net loss per share, basic and diluted | $ (0.33) | $ (0.57) | $ (1.70) | $ (1.99) |
Weighted-average common shares used to compute net loss per share, basic and diluted | 54,033 | 41,922 | 48,838 | 41,875 |
Product Sales | ||||
Revenue: | ||||
Total revenue | $ 8,060 | $ 10,512 | ||
Collaboration and License Revenue | ||||
Revenue: | ||||
Total revenue | $ 58,585 | $ 39,080 | $ 58,585 | $ 39,379 |
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 | $ (17,962) | $ (23,932) | $ (82,794) | $ (83,186) |
Other comprehensive income: | ||||
Unrealized gain on available-for-sale securities | 82 | 173 | 251 | 45 |
Total comprehensive loss | $ (17,880) | $ (23,759) | $ (82,543) | $ (83,141) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (unaudited) - USD ($) shares in Thousands, $ in Thousands | Total | Restricted stock unit settlement | Shelf offering | Common Stock | Common StockRestricted stock unit settlement | Common StockShelf offering | Additional Paid-In Capital | Additional Paid-In CapitalRestricted stock unit settlement | Additional Paid-In CapitalShelf offering | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||||||||
Effect of adoption of ASC 606 | ASC 606 | $ 29,895 | $ 29,895 | |||||||||
Balance at the beginning of the period at Dec. 31, 2017 | 149,649 | $ 42 | $ 703,215 | $ (215) | (553,393) | ||||||
Balance at the beginning of the period (in shares) at Dec. 31, 2017 | 41,798 | ||||||||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||||||||
Issuance of common stock (in shares) | 6 | ||||||||||
Exercise of stock options | 197 | 197 | |||||||||
Exercise of stock options (in shares) | 44 | ||||||||||
Stock-based compensation | 7,514 | 7,514 | |||||||||
Unrealized gain/(loss) on investments | (128) | (128) | |||||||||
Net loss | (59,254) | (59,254) | |||||||||
Balance at the end of the period at Mar. 31, 2018 | 127,873 | $ 42 | 710,926 | (343) | (582,752) | ||||||
Balance at the end of the period (in shares) at Mar. 31, 2018 | 41,848 | ||||||||||
Balance at the beginning of the period at Dec. 31, 2017 | 149,649 | $ 42 | 703,215 | (215) | (553,393) | ||||||
Balance at the beginning of the period (in shares) at Dec. 31, 2017 | 41,798 | ||||||||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||||||||
Unrealized gain/(loss) on investments | 45 | ||||||||||
Net loss | (83,186) | ||||||||||
Balance at the end of the period at Jun. 30, 2018 | 112,447 | $ 42 | 719,259 | (170) | (606,684) | ||||||
Balance at the end of the period (in shares) at Jun. 30, 2018 | 42,003 | ||||||||||
Balance at the beginning of the period at Mar. 31, 2018 | 127,873 | $ 42 | 710,926 | (343) | (582,752) | ||||||
Balance at the beginning of the period (in shares) at Mar. 31, 2018 | 41,848 | ||||||||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||||||||
Issuance of common stock (in shares) | 21 | ||||||||||
Exercise of stock options | 73 | 73 | |||||||||
Exercise of stock options (in shares) | 37 | ||||||||||
Purchases under employee stock purchase plan | 954 | 954 | |||||||||
Purchases under employee stock purchase plan (in shares) | 97 | ||||||||||
Stock-based compensation | 7,306 | 7,306 | |||||||||
Unrealized gain/(loss) on investments | 173 | 173 | |||||||||
Net loss | (23,932) | (23,932) | |||||||||
Balance at the end of the period at Jun. 30, 2018 | 112,447 | $ 42 | 719,259 | (170) | (606,684) | ||||||
Balance at the end of the period (in shares) at Jun. 30, 2018 | 42,003 | ||||||||||
Balance at the beginning of the period at Dec. 31, 2018 | (9,039) | $ 42 | 736,095 | (138) | (745,038) | ||||||
Balance at the beginning of the period (in shares) at Dec. 31, 2018 | 42,328 | ||||||||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||||||||
Issuance of common stock | $ 140,183 | $ 12 | $ 140,171 | ||||||||
Issuance of common stock (in shares) | 9 | 11,283 | |||||||||
Exercise of stock options | 23 | 23 | |||||||||
Exercise of stock options (in shares) | 13 | ||||||||||
Stock-based compensation | 8,090 | 8,090 | |||||||||
Unrealized gain/(loss) on investments | 169 | 169 | |||||||||
Net loss | (64,832) | (64,832) | |||||||||
Balance at the end of the period at Mar. 31, 2019 | 74,594 | $ 54 | 884,379 | 31 | (809,870) | ||||||
Balance at the end of the period (in shares) at Mar. 31, 2019 | 53,633 | ||||||||||
Balance at the beginning of the period at Dec. 31, 2018 | (9,039) | $ 42 | 736,095 | (138) | (745,038) | ||||||
Balance at the beginning of the period (in shares) at Dec. 31, 2018 | 42,328 | ||||||||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||||||||
Unrealized gain/(loss) on investments | 251 | ||||||||||
Net loss | (82,794) | ||||||||||
Balance at the end of the period at Jun. 30, 2019 | 65,556 | $ 54 | 893,221 | 113 | (827,832) | ||||||
Balance at the end of the period (in shares) at Jun. 30, 2019 | 54,398 | ||||||||||
Balance at the beginning of the period at Mar. 31, 2019 | 74,594 | $ 54 | 884,379 | 31 | (809,870) | ||||||
Balance at the beginning of the period (in shares) at Mar. 31, 2019 | 53,633 | ||||||||||
Increase (Decrease) in Shareholders' Equity (Deficit) | |||||||||||
Issuance of common stock | $ (490) | $ (490) | |||||||||
Issuance of common stock (in shares) | 503 | ||||||||||
Exercise of stock options | 382 | 382 | |||||||||
Exercise of stock options (in shares) | 96 | ||||||||||
Purchases under employee stock purchase plan | 1,371 | 1,371 | |||||||||
Purchases under employee stock purchase plan (in shares) | 166 | ||||||||||
Stock-based compensation | 7,579 | 7,579 | |||||||||
Unrealized gain/(loss) on investments | 82 | 82 | |||||||||
Net loss | (17,962) | (17,962) | |||||||||
Balance at the end of the period at Jun. 30, 2019 | $ 65,556 | $ 54 | $ 893,221 | $ 113 | $ (827,832) | ||||||
Balance at the end of the period (in shares) at Jun. 30, 2019 | 54,398 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) (unaudited) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Shelf offering | |
Issuance costs | $ 9,318 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Cash flows from operating activities | ||
Net loss | $ (82,794) | $ (83,186) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 294 | 244 |
Stock-based compensation | 15,491 | 14,820 |
Amortization of discount for payments related to acquired in-process research and development | 3,760 | |
Net (accretion) amortization of premiums on available-for-sale securities | (1,265) | 357 |
Amortization of debt discount and issuance costs | 1,087 | 916 |
Amortization of operating lease right-of-use assets | 1,645 | |
Impairment of intangible assets | 1,126 | |
Loss on disposal of assets | 101 | |
Changes in assets and liabilities: | ||
Trade and other receivables, net | (54,071) | (4) |
Inventory | (9,095) | (102) |
Prepaid expenses and other current assets | (17,691) | (3,707) |
Other assets | 1,932 | (543) |
Accounts payable | (4,315) | (2,697) |
Accrued liabilities | (1,821) | (1,238) |
Refund liability | (7,180) | |
Other long-term liabilities | 128 | |
Lease liabilities | (1,700) | |
Deferred revenue | 21,415 | (379) |
Deferred taxes | (194) | |
Net cash used in operating activities | (130,787) | (77,879) |
Cash flows from investing activities | ||
Purchases of available-for-sale securities | (163,822) | (233,001) |
Maturities of available-for-sale securities | 152,060 | 190,615 |
Purchase of property and equipment | (30) | (574) |
Net cash used in investing activities | (11,792) | (42,960) |
Cash flows from financing activities | ||
Net proceeds from issuance of common stock in connection with equity financings | 140,170 | |
Payments for debt issuance cost | (708) | |
Net proceeds from issuance of common stock in connection with equity awards | 1,298 | 1,224 |
Net cash provided by financing activities | 140,760 | 1,224 |
Net decrease in cash and cash equivalents and restricted cash | (1,819) | (119,615) |
Cash and cash equivalents and restricted cash at beginning of year | 105,778 | 296,723 |
Cash and cash equivalents and restricted cash at end of period | $ 103,959 | $ 177,108 |
Organization
Organization | 6 Months Ended |
Jun. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization | 1. Organization We are a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. We are committed to understanding the needs of both patients and physicians and using our insight to identify, develop and commercialize leading-edge medical dermatology products. Our approved treatment, QBREXZA™ (glycopyrronium) cloth (“QBREXZA”), is indicated for adult and pediatric patients (ages nine and older) with primary axillary hyperhidrosis (excessive underarm sweating). We are evaluating lebrikizumab for the treatment of moderate-to-severe atopic dermatitis (a severe form of eczema) and plan to initiate a Phase 3 clinical development program by the end of 2019. We also have early-stage research and development programs in other areas of dermatology |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation Our condensed consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and, in the opinion of our management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair presentation of our financial information. The results of operations for the three- and six-month periods ended June 30, 2019 are not necessarily indicative of the results to be expected for the full year ending December 31, 2019 or any other future period. The condensed consolidated balance sheet as of December 31, 2018 has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements include the accounts of our wholly owned subsidiary, Dermira Canada. All intercompany accounts and transactions have been eliminated in consolidation. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with our audited consolidated financial statements and the related notes thereto for the year ended December 31, 2018 included in our Annual Report on Form 10-K, filed with the SEC on February 26, 2019. Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates, including those related to revenue recognition and variable consideration, inventory, acquired in-process research and development, investments, accrued research and development expenses, goodwill, operating lease assets and liabilities, intangible assets, other long-lived assets, stock-based compensation and the valuation of deferred tax assets. We base our estimates on our historical experience and also on assumptions that we believe are reasonable; however, actual results could significantly differ from those estimates. Restricted Cash Restricte d cash primarily consists of letters of credit collateralized by a money market account pursuant to certain lease and sublease agreements. Concentration of Credit Risk Financial instruments that potentially subject us to a concentration of credit risk consist primarily of cash and cash equivalents, investments and trade and other receivables. We invest in money market funds, U.S. Treasury securities, corporate debt, repurchase agreements, U.S. Government agency securities, commercial paper and certificates of deposits. Bank deposits are held primarily by a limited number of financial institutions and these deposits may exceed insured limits. We are exposed to credit risk in the event of a default by the financial institutions holding our cash and cash equivalents and issuers of investments to the extent recorded on the consolidated balance sheets. Our investment policy limits investments to money market funds, certain types of debt securities issued by the U.S. Government and its agencies, corporate debt, repurchase agreements, commercial paper, certificates of deposit and municipal bonds and places restrictions on the credit ratings, maturities and concentration by type and issuer. As of and for the three and six months ended June 30, 2019, three customers (AmerisourceBergen Corporation, McKesson Corporation and Cardinal Health, Inc.) each accounted for more than 10% of our trade receivables and product sales. These three customers collectively accounted for 97.5% and 96.7% of product sales for the three and six months ended June 30, 2019, respectively, and 99.1% of our trade receivables as of June 30, 2019. As of June 30, 2019, we have a receivable of $50.0 million from Almirall, S.A. (“Almirall”), which was recorded in trade and other receivables, net. Trade and Other Receivables Our trade receivables consist of amounts due from the sale of QBREXZA. The trade receivables are recorded net of allowances for distribution fees and trade discounts, government rebates and chargebacks. Estimates for wholesaler chargebacks for government rebates and cash discounts are based on contractual terms, historical trends and our expectations regarding the utilization rates for these programs. For the periods presented, we did not have any write-offs of trade receivables. We perform ongoing credit evaluations of our Customers and generally do not require collateral. Other receivables, including collaboration and license receivables, are typically unsecured. Accordingly, we may be exposed to credit risk generally associated with our collaboration and license agreements. To date, we have not experienced any losses related to these receivables. Inventory Inventory consists of raw materials, work-in-process and finished goods related to the production of QBREXZA. Inventory costs are determined using the lower of standard cost, which approximates the actual costs determined using the first-in, first-out basis, or net realizable value. Standard costs are reviewed and updated annually or as needed. We expense costs associated with the manufacture of our products prior to regulatory approval and capitalize the cost of inventory when there is a high probability of future economic benefit. We began capitalizing the cost of inventory related to QBREXZA in the second quarter of 2018, the period in which we received regulatory approval to market the product. We expense costs associated with the manufacture of our lebrikizumab product candidate. We review all inventory balances on a quarterly basis for impairment and recognize any reduction in value as a current period expense with a reserve provision on the condensed consolidated balance sheets. We write down inventory that is in excess of expected requirements or at risk of expiration. This assessment requires management to utilize judgment in formulating estimates and assumptions that we believe to be reasonable under the circumstances. Actual results may differ from those estimates and assumptions. If the conditions that caused the impairment were to be resolved in a subsequent period, the reserve provision would not be reversed until the related inventory was sold or otherwise disposed. As of June 30, 2019, the carrying value of our inventory was $17.6 million, including finished goods inventory of $5.6 million which has fixed expiration dates. In addition, we have manufacturing purchase commitments during the next 12 months of $11.0 million related to QBREXZA. In order to realize the value of our recorded inventory, we will be dependent upon significant increases in the sales volumes of QBREXZA. Leases We adopted Accounting Standards Update (“ASU”) No. 2016‑02, Leases As our leases do not provide an implicit rate, we estimated the rate of interest. In order to estimate the interest rate, we utilized the effective interest rate derived from recent debt transactions, adjusting it for factors that reflect the profile of secured borrowing over the expected term of the lease, including our credit rating. We elected the practical expedients permitted under Topic 842, which allowed us to exclude from our condensed consolidated balance sheets recognition of leases having a term of 12 months or less (short-term leases) and we elected to not separate lease components and non-lease components for our long-term real-estate leases. Rent expense for the operating lease is recognized on a straight-line basis over the lease term and is included in operating expenses on the condensed consolidated statements of operations. Variable lease payments include lease operating expenses. Prior period amounts continue to be reported in accordance with our historic accounting under previous lease guidance, ASC 840, Leases Revenue Recognition We recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the 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 the performance obligations. At contract inception, we assess the goods or services promised within each contract and assess whether each promised good or service is distinct and determine those that are Product Sales Our product sales consist of sales of QBREXZA, which became available in pharmacies within the United States on October 1, 2018. We recognize revenue from product sales when our wholesalers and a preferred dispensing partner (together, “Customers”) Product sales are recognized at the transaction price, net of estimates of variable consideration, including commercial rebates, discounts related to a savings card program, distribution fees, trade discounts, government rebates and chargebacks and product returns. Variable consideration amounts are estimated at contract inception using the expected-value method and updated at the end of each reporting period as additional information becomes available. The amounts of variable consideration are included in the transaction price only to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. Estimates and assumptions are updated quarterly and if actual future results vary materially from estimates, we will record an adjustment, which could impact product sales and earnings in the period of adjustment. The following items of variable consideration are recorded at the time of revenue recognition and require significant estimates and judgment. Commercial rebates and savings card program. We contract with certain third-party payers for the payment of rebates with respect to the utilization of QBREXZA. Rebates to these payers are based on contractual percentages applied to the amount of QBREXZA prescribed to patients who are covered by the plan or the organization with which we have contracts. We estimate and record rebates as a reduction to the transaction price in the same period the related product sales are recognized. We estimate commercial rebates based on contractual terms, estimated payer mix, industry information and other third-party data. We also have a savings card program to provide assistance to eligible patients with out-of-pocket costs, such as deductibles, co-insurance and co-payments, for the patient’s usage of QBREXZA. Reductions to product sales for the savings card program are estimated based on actual and expected program utilization. Distribution fees and trade discounts. We pay our Customers certain fees for distribution services for QBREXZA. We have determined that such distribution services are not distinct from our sales of QBREXZA and the related fees are recorded as a reduction to the transaction price in the period the related product sales are recognized. Distribution fees are recorded based on contractual terms. We also incentivize prompt payment from our Customers by providing a discount for payments made within a certain number of days. Government rebates and chargebacks. We are subject to discount obligations under state Medicaid programs, Medicare and other government programs. Reserves for these rebates and chargebacks are recorded as a reduction to the transaction price in the period the related product sales are recognized. Chargeback amounts represent credit we expect to issue to our Customers and are recorded as a reduction to trade and other receivables, net. Reductions to product sales for government managed programs are estimated based on statutorily-defined discounts, estimated payer mix, expected sales to qualified healthcare providers and expected utilization. Product returns. Our product return policy provides our Customers the right to return QBREXZA, generally based on the product expiration date. The reserve for product returns is recorded as a reduction to the transaction price in the period the related product sales are recognized. We estimate product returns using third-party input and market data for products with characteristics similar to QBREXZA. As of June 30, 2019, the balance of our revenue-related reserves, consisting of commercial rebates, discounts related to the savings card program, distribution fees, trade discounts, government rebates, chargebacks and product returns, was $3.5 million, of which $1.2 million was recorded as a direct deduction from trade and other receivables and $2.3 million was recorded in accrued liabilities on the condensed consolidated balance sheets. As of December 31, 2018, the balance of these revenue-related reserves was $2.5 million, of which $0.7 million was recorded as a direct deduction from trade and other receivables and $1.8 million was recorded in accrued liabilities on the condensed consolidated balance sheets. During the three and six months ended June 30, 2019, additions to the revenue-related reserves were $5.2 million and $12.9 million, respectively, which were offset by related credits or payments of $5.1 million and $11.9 million, respectively. Collaborative Arrangements We enter into collaborative arrangements that typically include one of more of the following: (i) license fees; (ii) milestone payments related to the achievement of developmental, regulatory, or commercial goals; (iii) royalties on net sales of licensed products; and (iv) fees attributable to options to intellectual property. When a portion of non‑refundable up-front fees or other payments received are allocated to continuing performance obligations under the terms of a collaborative arrangement, they are recorded as deferred revenue and recognized as revenue when (or as) the underlying performance obligation is satisfied. Fees attributable to options are deferred until the option expires or is exercised. When an option is exercised, the performance obligations associated with the option are identified, which will determine the accounting for the transaction price attributable to the option. As part of the accounting for these arrangements, we must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligation. The stand-alone selling price may include items such as forecasted revenues, development timelines, discount rates, and probabilities of technical and regulatory success. We evaluate each performance obligation to determine if it can be satisfied at a point in time or over time. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. Under certain collaborative arrangements, we have been reimbursed for a portion of our research and development (“R&D”) expenses, including costs of drug supplies. When these R&D services are performed under a reimbursement or cost sharing model with our collaboration partner, we record these reimbursements as a reduction of R&D expense in our consolidated statements of operations. License Fees If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Milestone Payments At the inception of each arrangement that includes milestone payments (variable consideration), we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or our collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, we re-evaluate the probability of achievement of such milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration or other revenues and earnings in the period of adjustment. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, we have not recognized any royalty revenue resulting from any of our collaborative arrangements. Advertising Expenses We expense the costs of advertising as incurred. Advertising expenses were $26.7 million and $14.6 million for the three months ended June 30, 2019 and 2018, respectively, and $36.2 million and $21.5 million for the six months ended June 30, 2019 and 2018, respectively. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for dilutive potential shares of common stock. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive for all periods presented. The following common stock equivalent shares were not included in the computations of diluted net loss per share for the periods presented because their effect was antidilutive (in thousands): Outstanding as of June 30, 2019 2018 Stock options to purchase common stock 7,424 7,374 Shares subject to outstanding restricted stock units 1,953 1,544 Estimated shares issuable under the employee stock purchase plan 610 446 Shares issuable upon conversion of convertible notes 8,110 8,110 18,097 17,474 Recent Accounting Pronouncements In November 2018, the Financial Accounting Standards Board (“FASB”) issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 Collaborative Arrangements Revenue from Contracts with Customers In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which amended certain disclosure requirements over Level 1, Level 2 and Level 3 fair value measurements. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019 and interim periods within those fiscal years. Early adoption is permitted. We are currently evaluating the impact of adopting ASU 2018-13, but do not anticipate it will have a material impact on our disclosures. In February 2016, the issued Topic 842 Topic 840 Topic 842 Impact of Balance Sheet January 1, 2019 January 1, 2019 Adoption Deferred rent classified as accrued liabilities $ (134 ) $ — $ 134 Deferred rent classified as other long-term liabilities (1,015 ) — 1,015 Operating lease right-of-use asset — 14,788 14,788 Lease liability, current — (4,551 ) (4,551 ) Lease liability, non-current $ — $ (11,386 ) $ (11,386 ) |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements Fair value is defined 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 should maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting guidance for fair value establishes a three-level hierarchy for disclosure of fair value measurements, as follows: Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. Level 2—Inputs (other than quoted market prices included in Level 1) that are either directly or indirectly observable, 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 instrument’s anticipated life. Level 3—Unobservable inputs that are supported by little or no market activity and reflect our best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Where quoted prices are available in an active market, securities are classified as Level 1. When quoted market prices are not available for the specific security, then we estimate fair value by using quoted prices for identical or similar instruments in markets that are not active and model‑based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable, these models project future cash flows and discount the future amounts to a present value using market‑based observable inputs obtained from various third‑party data providers, including but not limited to benchmark yields, reported trades and broker/dealer quotes. There were no The following tables set forth the fair value of our financial assets, which consists of investments classified as available-for-sale securities, that were measured on a recurring basis (in thousands): As of June 30, 2019 Fair Value Hierarchy Level Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Financial assets: Money market funds Level 1 $ 23,200 $ — $ — $ 23,200 U.S. Treasury securities Level 1 63,336 57 — 63,393 Corporate debt Level 2 71,701 56 (7 ) 71,750 U.S. Government agency securities Level 2 14,997 7 — 15,004 Commercial paper Level 2 147,731 — — 147,731 Total investments $ 320,965 $ 120 $ (7 ) $ 321,078 As of December 31, 2018 Fair Value Hierarchy Level Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Financial assets: Money market funds Level 1 $ 21,201 $ — $ — $ 21,201 U.S. Treasury securities Level 1 84,098 5 (56 ) 84,047 Corporate debt Level 2 98,367 2 (88 ) 98,281 U.S. Government agency securities Level 2 1,984 — (1 ) 1,983 Commercial paper Level 2 102,781 — — 102,781 Total investments $ 308,431 $ 7 $ (145 ) $ 308,293 As of June 30, 2019, we did not hold any investments that have been in a continuous loss position for 12 months or more. We do not intend to sell the securities that are in an unrealized loss position and we believe it is more likely than not that the investments will be held until recovery of the amortized cost bases. We have determined that the gross unrealized losses on our securities as of June 30, 2019 were temporary in nature. The estimated fair value of our term loan was $34.8 million as of June 30, 2019 and was based on interest rates currently available to us for debt with similar terms. The estimated fair value of our convertible notes was $249.4 million as of June 30, 2019 and was based upon observable, Level 2 inputs, including pricing information from recent trades of the convertible notes as of June 30, 2019. |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2019 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | 4. Balance Sheet Components Inventory Inventory consists of the following (in thousands): June 30, December 31, 2019 2018 Raw materials $ 11,441 $ 4,140 Work-in process 602 1,019 Finished goods 5,601 3,211 Total inventory $ 17,644 $ 8,370 Accrued liabilities consist of the following (in thousands): June 30, December 31, 2019 2018 Accrued compensation $ 9,056 $ 12,510 Accrued outside research and development services 4,014 3,431 Accrued professional and consulting services 3,097 3,476 Accrued interest 1,123 1,102 Other 2,739 2,089 Total accrued liabilities $ 20,029 $ 22,608 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Leases | 5. Leases We lease our corporate headquarters in Menlo Park, California under a non-cancelable operating lease agreement entered into in July 2014, as amended (“Lease”). Pursuant to the Lease, we lease 45,192 square feet of space in a multi-suite building (the “Building”). As of June 30, 2019, rent payments under the Lease include base rent with an annual increase of three percent, and additional monthly fees to cover our share of certain facility expenses, including utilities, property taxes, insurance and maintenance. The Lease will expire on December 31, 2021, subject to our option to renew the Lease for an additional five-year term. Pursuant to the terms of the Lease, we provided the lessor with a $500,000 letter of credit in August 2014, which is collateralized by a money market account. The letter of credit may be used by or drawn upon by the lessor in the event of our default of certain terms of the Lease. If no such event of default has occurred or then exists, the letter of credit may be reduced to $350,000 after June 1, 2019. The collateralized money market account is restricted cash and recorded in our condensed consolidated balance sheets. In connection with the Lease, we recognized an operating lease right-of-use asset of $7.5 million and an aggregate lease liability of $8.2 million as of January 1, 2019 in our condensed consolidated balance sheet. As of January 1, 2019, the remaining Lease term was 3.0 years, and we used an estimated discount rate of In September 2017, we entered into a sublease agreement (“Sublease”) pursuant to which we expanded our office space by subleasing an additional 23,798 square feet of space in the Building. Rent payments for the Sublease include base rent with an annual increase of three percent, and additional monthly fees to cover our share of certain facility expenses, including utilities, property taxes, insurance and maintenance. The Sublease term commenced on December 20, 2017, and will end on April 30, 2024, unless terminated early pursuant to the terms of the Sublease. Pursuant to the terms of the Sublease, in October 2017, we provided the sublessor with a $300,000 irrevocable commercial letter of credit, which is collateralized by a money market account. The letter of credit may be used by or drawn upon by the sublessor in the event of our default of certain terms of the Sublease. The collateralized money market account is restricted cash and recorded in our condensed consolidated balance sheets. In connection with the Sublease, we recognized an operating lease right-of-use asset of $7.2 million and an aggregate lease liability of $7.7 million as of January 1, 2019 in our condensed consolidated balance sheet. As of January 1, 2019, the remaining Sublease term was 5.3 years, and we used an estimated discount rate of Rent expense for the Lease and Sublease was $1.6 million and $1.5 million for the three months ended June 30, 2019 and 2018, respectively, and $3.2 million and $3.0 million for the six months ended June 30, 2019 and 2018, respectively, which includes As of June 30, 2019, the undiscounted future non-cancellable lease payments under the Lease and Sublease were as follows (in thousands): Year Ending December 31, 2019 (remainder) $ 1,995 2020 4,918 2021 5,056 2022 1,879 2023 1,936 Thereafter 666 Total undiscounted lease payments 16,450 Less: Present value adjustment (2,609 ) Total $ 13,841 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2019 | |
Debt Disclosure [Abstract] | |
Debt | 6. Debt Credit Facility In December 2018, we entered into a Credit Agreement (“Credit Agreement”) with Athyrium Opportunities III Acquisition LP (“Athyrium”). The arrangement provides for a senior secured term loan facility of up to $125.0 million in aggregate principal amount available in three tranches, $35.0 million of which was funded upon the closing. The second tranche of $40.0 million may be borrowed in a single draw at our option on or before July 1, 2019 and the third tranche of $50.0 million may be borrowed in a single draw on or before March 2, 2020 subject to a performance-based milestone. Amounts outstanding under the Credit Agreement bear interest at a rate of 10.75% per year, payable in quarterly in arrears, and provide for interest-only payments followed by payment of principal at maturity in December 2023; provided, however, that if, as of February 13, 2022, the aggregate outstanding principal amount of our 3.00% Convertible Senior Notes due 2022 (“Notes”) is greater than $60.0 million, we must immediately repay all amounts outstanding under the Credit Agreement, together with all accrued and unpaid interest and the applicable prepayment premium, if any. After the occurrence and during the continuation of a default, amounts outstanding will bear interest at a rate of 13.75% per annum, payable in cash quarterly in arrears and on demand. Our obligations under the Credit Agreement are secured by a security interest in, subject to certain exceptions, substantially all of our assets. We may make voluntary prepayments in whole or in part, subject to certain prepayment premiums and additional interest payments. The Credit Agreement also contains certain provisions, such as default and change in control provisions, which, if triggered, would require us to make mandatory prepayments on the term loan, which are subject to certain prepayment premiums and additional interest payments. We determined that these contingent prepayment provisions were an embedded component that qualified as a derivative which should be bifurcated from the term loan and accounted for separately from the host contract. As of June 30, 2019, the fair value of this embedded derivative was immaterial. The Credit Agreement also contains representations and warranties and affirmative and negative covenants customary for financings of this type as well as customary events of default. As of June 30, 2019 and December 31, 2018, we were in compliance with all of the covenants under the Credit Agreement. In connection with issuance of the term loan, we incurred certain costs and fees totaling $2.5 million which were recorded as a direct deduction discount from the term loan on the consolidated balance sheets and are being amortized ratably to interest expense over the term of the loan, using the effective interest method. As of June 30, 2019, there were unamortized issuance costs and debt discounts of $2.3 million related to the term loan. We recorded $1.0 million and $2.1 million in interest expense related to the term loan for the three and six months ended June 30, 2019, respectively. As of June 30, 2019, minimum aggregate future payments under the term loan are as follows (in thousands): 2019 (remainder) $ 1,891 2020 3,763 2021 3,763 2022 3,763 2023 38,521 Total minimum payments $ 51,701 Amount representing interest (16,701 ) Principal amount of term loan $ 35,000 On August 5, 2019, we amended the Credit Agreement to extend the deadline for the drawing of the third tranche of $50.0 million from March 2, 2020 to June 3, 2020 and reduce the prepayment penalty. In connection with this amendment, we paid Athyrium an amendment fee of $350,000 and borrowed $40.0 million available under the second tranche. Convertible notes In May 2017, we sold $287.5 million aggregate principal amount of Notes in a private placement. We received net proceeds of $278.3 million, after deducting the initial purchasers’ discounts of $8.6 million and issuance costs of $0.6 million. The Notes were issued pursuant to an Indenture, dated as of May 16, 2017 (the “Indenture”), between us and U.S. Bank National Association, as trustee. The Notes are senior, unsecured obligations and bear interest at a rate of 3.00% per year, payable in cash semi-annually in arrears on May 15 and November 15 of each year, beginning on November 15, 2017. The Notes mature on May 15, 2022, unless earlier converted or repurchased in accordance with their terms. The Notes are convertible into shares of our common stock, par value $0.001 per share, at an initial conversion rate of 28.2079 shares of common stock per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $35.45 per share of common stock. The conversion rate and the corresponding conversion price are subject to adjustment upon the occurrence of certain events, but will not be adjusted for any accrued and unpaid interest. Holders of the Notes who convert their Notes in connection with a make-whole fundamental change (as defined in the Indenture) are, under certain circumstances, entitled to an increase in the conversion rate. Additionally, in the event of a fundamental change, holders of the Notes may require us to repurchase all or a portion of their Notes at a price equal to 100% of the principal amount of Notes, plus any accrued and unpaid interest, including any additional interest to, but excluding, the repurchase date. Holders of the Notes may convert all or a portion of their Notes at their option at any time prior to the close of business on the business day immediately prior to May 15, 2022, in multiples of $1,000 principal amount. As of June 30, 2019, there were unamortized issuance costs and debt discounts of $5.4 million, which were recorded as a direct deduction from the Notes on the condensed consolidated balance sheets. |
Collaboration and License Agree
Collaboration and License Agreements | 6 Months Ended |
Jun. 30, 2019 | |
Collaboration And License Agreements [Abstract] | |
Collaboration and License Agreements | 7. Collaboration and License Agreements In-License Agreements Roche Agreement In August 2017, we entered into a licensing agreement (“Roche Agreement”) with F. Hoffmann-La Roche Ltd and Genentech, Inc. (together, “Roche”), pursuant to which we obtained exclusive, worldwide rights to develop and commercialize lebrikizumab, an injectable, humanized antibody targeting interleukin 13, for atopic dermatitis and all other therapeutic indications. The Roche Agreement became effective in September 2017 and was amended in February 2019. Under the terms of the Roche Agreement, we made an initial payment of $80.0 million to Roche in October 2017 and a $25.0 million payment to Roche in July 2018 upon the achievement of 50% enrollment in our Phase 2 clinical study of lebrikizumab, which was achieved in June 2018, and a $30.0 million payment in November 2018 related to the achievement of 100% enrollment in our Phase 2 clinical study of lebrikizumab, which was achieved in October 2018. We amended the Roche Agreement in February 2019. Under the terms of the Roche Agreement, as amended, Roche is obligated to supply us with up to approximately $16.0 million in existing lebrikizumab drug substance, free of charge, approximately two-thirds of which was received as of June 30, 2019, and we will be obligated to make payments to Roche upon the achievement of certain milestones, comprising $20.0 million upon the initiation of the first Phase 3 clinical study, up to $180.0 million upon the achievement of regulatory and first commercial sale milestones in certain territories and up to $1.0 billion based on the achievement of certain thresholds for net sales of lebrikizumab for all indications. Under the terms of the Roche Agreement, as amended, we will also make royalty payments to Roche representing percentages of net sales. Royalty payments will be made from the first commercial sale date in such country and end on the later of the date that is (i) ten years after the date of the first commercial sale of lebrikizumab in such country, (ii) the expiration of the last to expire valid claim of the applicable licensed compound patent rights, our patent rights or joint patent rights in such country covering the use, manufacturing, import, offering for sale, or sale of lebrikizumab in such country, (iii) the expiration of the last to expire valid claim of the applicable licensed non-compound patent rights in such country covering the use, import, offering for sale, or sale of the product in such country, or (iv) the expiration of the last to expire regulatory exclusivity conferred by the applicable regulatory authority in such country for lebrikizumab. Rose U Agreement In April 2013, we entered into an exclusive license agreement with Rose U LLC (“Rose U”) pursuant to which we obtained a worldwide exclusive license within a field of use including hyperhidrosis to practice, enforce and otherwise exploit certain patent rights, know‑how and data related to our hyperhidrosis program. The license of certain data and an assignment of certain regulatory filings which Rose U had obtained from pursuant to which we assumed Rose U’s obligation to pay Stiefel $2.5 million in connection with the commercialization of products developed using the licensed data and to indemnify Stiefel for claims arising from the use, development or commercialization of products developed using the Stiefel data As of June 30, 2019, we have paid or accrued license and other fees of $4.3 million to Rose U and Stiefel, including a $2.5 million payment in connection with the first commercial sale of QBREXZA in 2018, and are required to pay Rose U additional amounts totaling up to $0.6 million upon the achievement of certain milestones. In addition, we are also obligated to pay Rose U low-to-mid single-digit royalties on net product sales and low double-digit royalties on sublicense fees and certain milestone, royalty and other contingent payments received from sublicensees, to the extent such amounts are in excess of the milestone and royalty payments we are obligated to pay Rose U directly upon the events or sales triggering such payments. Under the license agreement, we are entitled to credit the $2.5 million payment we paid in connection with the first commercial sale of QBREXZA against royalty payments owed to Rose U in accordance with the terms of the license agreement. As of June 30, 2019, the remaining creditable amount of this payment was $2.2 million. Out-License and Other Agreements Almirall Agreement We entered into an option and license agreement with Almirall in February 2019 (“Almirall Agreement”), under which Almirall acquired an option to exclusively license rights to develop lebrikizumab for the treatment or prevention of dermatology indications, including but not limited to atopic dermatitis, and commercialize lebrikizumab for the treatment or prevention of all indications in Europe (“Lebrikizumab EU License”). In exchange, we received a non-refundable upfront option fee of $30.0 million in March 2019. In June 2019, Almirall exercised its option pursuant to the Almirall Agreement. In connection with this exercise, Almirall paid us an option exercise fee of $50.0 million, which we received in July 2019. Under the terms of the Almirall Agreement, we are entitled to receive additional payments upon the achievement of certain development, regulatory and sales milestones, including $30.0 million in connection with the initiation by us of certain Phase 3 clinical studies, as well as royalty payments representing percentages of net sales of lebrikizumab in Europe. Upon Almirall’s election to exercise its option pursuant to the Almirall Agreement, we identified the following distinct performance obligations: (i) the delivery of the Lebrikizumab EU License and (ii) the conduct of the lebrikizumab Phase 3 development program. We determined that the transaction price as of June 30, 2019 was $110.0 million, consisting of: (i) the $30.0 million upfront option fee; (ii) the $50.0 million option exercise fee; and (iii) the $30.0 million in milestones in connection with the initiation of certain Phase 3 clinical studies, which were determined to not be constrained. Other future potential regulatory milestones were considered to be fully constrained, as we determined that the achievement of such milestones is contingent upon success in future clinical trials and regulatory approvals, which are not within our control and are uncertain at this stage. We expect that the sales-based milestone and royalty payments will be recognized when the sales occur or the milestone is achieved. We will re-evaluate the transaction price each reporting period. We allocated the transaction price based on the estimated stand-alone selling prices of each of the two performance obligations. We determined the stand-alone selling price for the Lebrikizumab EU License was based on a discounted cash flow approach and considered several factors including, but not limited to: estimated market demand, manufacturing and supply costs, development and commercialization costs, discount rate, development and approval timelines and probabilities of technical and regulatory success. The portion of the transaction price allocated to our Lebrikizumab EU License performance obligation was recorded immediately upon Almirall’s exercise of its option in the second quarter of 2019, as the Lebrikizumab EU License represents functional intellectual property that was transferred as of the date of Almirall’s option exercise in June 2019. We determined the stand-alone selling price for our lebrikizumab Phase 3 development program based on the nature of the services to be performed, estimates of the associated costs and third-party rates for similar services. The portion of the transaction price allocated to our lebrikizumab Phase 3 development program performance obligation will be recognized as revenue using the input method as the lebrikizumab Phase 3 development program is completed, subject to changes in estimated total lebrikizumab development program cost and actual costs incurred during each period. No revenue related to the lebrikizumab Phase 3 development program performance obligation had been recognized as of June 30, 2019. For each of the three and six months ended June 30, 2019, we recognized $58.6 million as collaboration and license revenue related to the Almirall Agreement in our condensed consolidated statements of operations. As of June 30, 2019, $15.1 million and $6.3 million were recorded as deferred revenue, current, and deferred revenue, non-current, respectively, on the condensed consolidated balance sheets and are expected to be recognized as collaboration and license revenue over the Maruho Agreement In September 2016, we entered into an Exclusive License Agreement with Maruho Co., Ltd. (“Maruho”), which grants Maruho an exclusive license to develop and commercialize glycopyrronium tosylate for the treatment of hyperhidrosis in Japan (“Maruho Agreement”). Pursuant to the terms of the Maruho Agreement, we received an upfront payment of $25.0 million from Maruho in October 2016 and are eligible to receive additional payments totaling up to $70.0 million, contingent upon the achievement of certain milestones associated with submission and approval of a marketing application in Japan and certain sales thresholds, as well as royalty payments based on a percentage of net product sales in Japan. The Maruho Agreement further provides that Maruho will be responsible for funding all development and commercial costs for the program in Japan and, until such time, if any, as Maruho elects to establish its own source of supply of drug product, Maruho will purchase product supply from us for development and, if applicable, commercial purposes at cost. Under Topic 606, we evaluated the terms of the Maruho Agreement and the transfer of intellectual property rights (the “license”) was identified as the only performance obligation as of the inception of the agreement. We concluded that the license for the intellectual property was distinct from our ongoing manufacturing obligations. Unless earlier terminated, the Maruho Agreement will remain in effect until the later of: (i) expiration or abandonment of the last valid claim of the applicable patent rights in Japan; (ii) expiration of any market exclusivity in Japan granted by the applicable regulatory authority; and (iii) 15 years following the date of the first commercial sale of the drug product in Japan. UCB Agreements In March 2014, we and UCB Pharma S.A. (“UCB”), entered into a Development and Commercialisation Agreement, dated March 21, 2014 (“UCB Agreement”), which provided that we would (a) develop Cimzia (certolizumab pegol) for the treatment of psoriasis in order for UCB to seek regulatory approval from the U.S. Food and Drug Administration (“FDA”) As a result, we and UCB entered into an agreement on November 6, 2017 to effect the termination of the UCB Agreement and an orderly transition of the development and commercialization activities under the UCB Agreement from us to UCB (“Transition Agreement”). The Transition Agreement, among other things, (a) terminated the UCB Agreement on February 15, 2018, (b) provided for the repurchase by UCB of all product rights, licenses and intellectual property relating to Cimzia, (c) specified the responsibilities and obligations of us and UCB in connection with the transition of certain activities under the UCB Agreement from us to UCB as a result of the termination of the UCB Agreement, (d) terminated UCB’s right to designate a director nominee to our board of directors and (e) provided for the resignation of UCB’s designee from our board of directors. Pursuant to the UCB Agreement, there were no termination or penalty payments required by either party. In consideration for the repurchase of all product rights, licenses and intellectual property relating to Cimzia, UCB paid us $11.0 million in November 2017 and an additional $39.0 million in June 2018 upon FDA approval of Cimzia for the treatment of psoriasis. We were obligated to reimburse UCB for up to $10.0 million of development costs incurred by UCB in connection with the development of Cimzia between January 1, 2018 and June 30, 2018. For the three and six months ended June 30, 2018, we recognized $39.1 million and $39.4 million, respectively, in collaboration and license revenue in our condensed consolidated statement of operations related to UCB. As of December 31, 2018, we had fully reimbursed UCB the $10.0 million for development costs incurred by UCB. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation The following table reflects a summary of stock option activity under our 2010 Equity Incentive Plan (“2010 Plan”), 2014 Equity Incentive Plan (“2014 EIP”) and 2018 Equity Inducement Plan (“2018 Inducement Plan”) Shares Subject to Outstanding Stock Options Weighted- Average Exercise Price Per Share Stock options outstanding at December 31, 2018 6,950 $ 19.06 Stock options granted 1,025 $ 7.61 Stock options exercised (109 ) $ 3.70 Stock options forfeited (442 ) $ 23.38 Stock options outstanding at June 30, 2019 7,424 $ 17.45 The following table reflects a summary of restricted stock unit (“RSU”) activity under our 2014 EIP and 2018 Inducement Plan and related information for the period from December 31, 2018 through June 30, 2019: Shares Subject to Outstanding RSUs Weighted- Average Grant Date Fair Value Per Share RSUs outstanding at December 31, 2018 1,572 $ 13.50 RSUs granted 1,181 $ 7.17 RSUs vested and settled (557 ) $ 9.51 RSUs forfeited (243 ) $ 10.20 RSUs outstanding at June 30, 2019 1,953 $ 11.22 Total stock-based compensation expense related to the 2010 Plan, the 2014 EIP, the 2018 Inducement Plan and the 2014 Employee Stock Purchase Plan Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Cost of sales $ 16 $ — $ 31 $ — Research and development 2,371 2,408 4,831 5,261 Selling, general and administrative 5,123 4,898 10,629 9,559 Total stock-based compensation expense $ 7,510 $ 7,306 $ 15,491 $ 14,820 Stock-based compensation of $0.1 million and $0.2 million was capitalized into inventory for the three and six months ended June 30, 2019, respectively. Stock-based compensation capitalized into inventory is recognized as cost of sales when the related product is sold. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation Our condensed consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and, in the opinion of our management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair presentation of our financial information. The results of operations for the three- and six-month periods ended June 30, 2019 are not necessarily indicative of the results to be expected for the full year ending December 31, 2019 or any other future period. The condensed consolidated balance sheet as of December 31, 2018 has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements include the accounts of our wholly owned subsidiary, Dermira Canada. All intercompany accounts and transactions have been eliminated in consolidation. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with our audited consolidated financial statements and the related notes thereto for the year ended December 31, 2018 included in our Annual Report on Form 10-K, filed with the SEC on February 26, 2019. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates, including those related to revenue recognition and variable consideration, inventory, acquired in-process research and development, investments, accrued research and development expenses, goodwill, operating lease assets and liabilities, intangible assets, other long-lived assets, stock-based compensation and the valuation of deferred tax assets. We base our estimates on our historical experience and also on assumptions that we believe are reasonable; however, actual results could significantly differ from those estimates. |
Restricted Cash | Restricted Cash Restricte d cash primarily consists of letters of credit collateralized by a money market account pursuant to certain lease and sublease agreements. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject us to a concentration of credit risk consist primarily of cash and cash equivalents, investments and trade and other receivables. We invest in money market funds, U.S. Treasury securities, corporate debt, repurchase agreements, U.S. Government agency securities, commercial paper and certificates of deposits. Bank deposits are held primarily by a limited number of financial institutions and these deposits may exceed insured limits. We are exposed to credit risk in the event of a default by the financial institutions holding our cash and cash equivalents and issuers of investments to the extent recorded on the consolidated balance sheets. Our investment policy limits investments to money market funds, certain types of debt securities issued by the U.S. Government and its agencies, corporate debt, repurchase agreements, commercial paper, certificates of deposit and municipal bonds and places restrictions on the credit ratings, maturities and concentration by type and issuer. As of and for the three and six months ended June 30, 2019, three customers (AmerisourceBergen Corporation, McKesson Corporation and Cardinal Health, Inc.) each accounted for more than 10% of our trade receivables and product sales. These three customers collectively accounted for 97.5% and 96.7% of product sales for the three and six months ended June 30, 2019, respectively, and 99.1% of our trade receivables as of June 30, 2019. As of June 30, 2019, we have a receivable of $50.0 million from Almirall, S.A. (“Almirall”), which was recorded in trade and other receivables, net. |
Trade and Other Receivables | Trade and Other Receivables Our trade receivables consist of amounts due from the sale of QBREXZA. The trade receivables are recorded net of allowances for distribution fees and trade discounts, government rebates and chargebacks. Estimates for wholesaler chargebacks for government rebates and cash discounts are based on contractual terms, historical trends and our expectations regarding the utilization rates for these programs. For the periods presented, we did not have any write-offs of trade receivables. We perform ongoing credit evaluations of our Customers and generally do not require collateral. Other receivables, including collaboration and license receivables, are typically unsecured. Accordingly, we may be exposed to credit risk generally associated with our collaboration and license agreements. To date, we have not experienced any losses related to these receivables. |
Inventory | Inventory Inventory consists of raw materials, work-in-process and finished goods related to the production of QBREXZA. Inventory costs are determined using the lower of standard cost, which approximates the actual costs determined using the first-in, first-out basis, or net realizable value. Standard costs are reviewed and updated annually or as needed. We expense costs associated with the manufacture of our products prior to regulatory approval and capitalize the cost of inventory when there is a high probability of future economic benefit. We began capitalizing the cost of inventory related to QBREXZA in the second quarter of 2018, the period in which we received regulatory approval to market the product. We expense costs associated with the manufacture of our lebrikizumab product candidate. We review all inventory balances on a quarterly basis for impairment and recognize any reduction in value as a current period expense with a reserve provision on the condensed consolidated balance sheets. We write down inventory that is in excess of expected requirements or at risk of expiration. This assessment requires management to utilize judgment in formulating estimates and assumptions that we believe to be reasonable under the circumstances. Actual results may differ from those estimates and assumptions. If the conditions that caused the impairment were to be resolved in a subsequent period, the reserve provision would not be reversed until the related inventory was sold or otherwise disposed. As of June 30, 2019, the carrying value of our inventory was $17.6 million, including finished goods inventory of $5.6 million which has fixed expiration dates. In addition, we have manufacturing purchase commitments during the next 12 months of $11.0 million related to QBREXZA. In order to realize the value of our recorded inventory, we will be dependent upon significant increases in the sales volumes of QBREXZA. |
Leases | Leases We adopted Accounting Standards Update (“ASU”) No. 2016‑02, Leases As our leases do not provide an implicit rate, we estimated the rate of interest. In order to estimate the interest rate, we utilized the effective interest rate derived from recent debt transactions, adjusting it for factors that reflect the profile of secured borrowing over the expected term of the lease, including our credit rating. We elected the practical expedients permitted under Topic 842, which allowed us to exclude from our condensed consolidated balance sheets recognition of leases having a term of 12 months or less (short-term leases) and we elected to not separate lease components and non-lease components for our long-term real-estate leases. Rent expense for the operating lease is recognized on a straight-line basis over the lease term and is included in operating expenses on the condensed consolidated statements of operations. Variable lease payments include lease operating expenses. Prior period amounts continue to be reported in accordance with our historic accounting under previous lease guidance, ASC 840, Leases |
Revenue Recognition | Revenue Recognition We recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the 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 the performance obligations. At contract inception, we assess the goods or services promised within each contract and assess whether each promised good or service is distinct and determine those that are Product Sales Our product sales consist of sales of QBREXZA, which became available in pharmacies within the United States on October 1, 2018. We recognize revenue from product sales when our wholesalers and a preferred dispensing partner (together, “Customers”) Product sales are recognized at the transaction price, net of estimates of variable consideration, including commercial rebates, discounts related to a savings card program, distribution fees, trade discounts, government rebates and chargebacks and product returns. Variable consideration amounts are estimated at contract inception using the expected-value method and updated at the end of each reporting period as additional information becomes available. The amounts of variable consideration are included in the transaction price only to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. Estimates and assumptions are updated quarterly and if actual future results vary materially from estimates, we will record an adjustment, which could impact product sales and earnings in the period of adjustment. The following items of variable consideration are recorded at the time of revenue recognition and require significant estimates and judgment. Commercial rebates and savings card program. We contract with certain third-party payers for the payment of rebates with respect to the utilization of QBREXZA. Rebates to these payers are based on contractual percentages applied to the amount of QBREXZA prescribed to patients who are covered by the plan or the organization with which we have contracts. We estimate and record rebates as a reduction to the transaction price in the same period the related product sales are recognized. We estimate commercial rebates based on contractual terms, estimated payer mix, industry information and other third-party data. We also have a savings card program to provide assistance to eligible patients with out-of-pocket costs, such as deductibles, co-insurance and co-payments, for the patient’s usage of QBREXZA. Reductions to product sales for the savings card program are estimated based on actual and expected program utilization. Distribution fees and trade discounts. We pay our Customers certain fees for distribution services for QBREXZA. We have determined that such distribution services are not distinct from our sales of QBREXZA and the related fees are recorded as a reduction to the transaction price in the period the related product sales are recognized. Distribution fees are recorded based on contractual terms. We also incentivize prompt payment from our Customers by providing a discount for payments made within a certain number of days. Government rebates and chargebacks. We are subject to discount obligations under state Medicaid programs, Medicare and other government programs. Reserves for these rebates and chargebacks are recorded as a reduction to the transaction price in the period the related product sales are recognized. Chargeback amounts represent credit we expect to issue to our Customers and are recorded as a reduction to trade and other receivables, net. Reductions to product sales for government managed programs are estimated based on statutorily-defined discounts, estimated payer mix, expected sales to qualified healthcare providers and expected utilization. Product returns. Our product return policy provides our Customers the right to return QBREXZA, generally based on the product expiration date. The reserve for product returns is recorded as a reduction to the transaction price in the period the related product sales are recognized. We estimate product returns using third-party input and market data for products with characteristics similar to QBREXZA. As of June 30, 2019, the balance of our revenue-related reserves, consisting of commercial rebates, discounts related to the savings card program, distribution fees, trade discounts, government rebates, chargebacks and product returns, was $3.5 million, of which $1.2 million was recorded as a direct deduction from trade and other receivables and $2.3 million was recorded in accrued liabilities on the condensed consolidated balance sheets. As of December 31, 2018, the balance of these revenue-related reserves was $2.5 million, of which $0.7 million was recorded as a direct deduction from trade and other receivables and $1.8 million was recorded in accrued liabilities on the condensed consolidated balance sheets. During the three and six months ended June 30, 2019, additions to the revenue-related reserves were $5.2 million and $12.9 million, respectively, which were offset by related credits or payments of $5.1 million and $11.9 million, respectively. Collaborative Arrangements We enter into collaborative arrangements that typically include one of more of the following: (i) license fees; (ii) milestone payments related to the achievement of developmental, regulatory, or commercial goals; (iii) royalties on net sales of licensed products; and (iv) fees attributable to options to intellectual property. When a portion of non‑refundable up-front fees or other payments received are allocated to continuing performance obligations under the terms of a collaborative arrangement, they are recorded as deferred revenue and recognized as revenue when (or as) the underlying performance obligation is satisfied. Fees attributable to options are deferred until the option expires or is exercised. When an option is exercised, the performance obligations associated with the option are identified, which will determine the accounting for the transaction price attributable to the option. As part of the accounting for these arrangements, we must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligation. The stand-alone selling price may include items such as forecasted revenues, development timelines, discount rates, and probabilities of technical and regulatory success. We evaluate each performance obligation to determine if it can be satisfied at a point in time or over time. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. Under certain collaborative arrangements, we have been reimbursed for a portion of our research and development (“R&D”) expenses, including costs of drug supplies. When these R&D services are performed under a reimbursement or cost sharing model with our collaboration partner, we record these reimbursements as a reduction of R&D expense in our consolidated statements of operations. License Fees If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Milestone Payments At the inception of each arrangement that includes milestone payments (variable consideration), we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or our collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, we re-evaluate the probability of achievement of such milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration or other revenues and earnings in the period of adjustment. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, we have not recognized any royalty revenue resulting from any of our collaborative arrangements. |
Advertising Expenses | Advertising Expenses We expense the costs of advertising as incurred. Advertising expenses were $26.7 million and $14.6 million for the three months ended June 30, 2019 and 2018, respectively, and $36.2 million and $21.5 million for the six months ended June 30, 2019 and 2018, respectively. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for dilutive potential shares of common stock. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive for all periods presented. The following common stock equivalent shares were not included in the computations of diluted net loss per share for the periods presented because their effect was antidilutive (in thousands): Outstanding as of June 30, 2019 2018 Stock options to purchase common stock 7,424 7,374 Shares subject to outstanding restricted stock units 1,953 1,544 Estimated shares issuable under the employee stock purchase plan 610 446 Shares issuable upon conversion of convertible notes 8,110 8,110 18,097 17,474 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2018, the Financial Accounting Standards Board (“FASB”) issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 Collaborative Arrangements Revenue from Contracts with Customers In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which amended certain disclosure requirements over Level 1, Level 2 and Level 3 fair value measurements. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019 and interim periods within those fiscal years. Early adoption is permitted. We are currently evaluating the impact of adopting ASU 2018-13, but do not anticipate it will have a material impact on our disclosures. In February 2016, the issued Topic 842 Topic 840 Topic 842 Impact of Balance Sheet January 1, 2019 January 1, 2019 Adoption Deferred rent classified as accrued liabilities $ (134 ) $ — $ 134 Deferred rent classified as other long-term liabilities (1,015 ) — 1,015 Operating lease right-of-use asset — 14,788 14,788 Lease liability, current — (4,551 ) (4,551 ) Lease liability, non-current $ — $ (11,386 ) $ (11,386 ) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Schedule of Common Stock Equivalent Shares Not Included in Computations of Diluted Net Loss per Share | The following common stock equivalent shares were not included in the computations of diluted net loss per share for the periods presented because their effect was antidilutive (in thousands): Outstanding as of June 30, 2019 2018 Stock options to purchase common stock 7,424 7,374 Shares subject to outstanding restricted stock units 1,953 1,544 Estimated shares issuable under the employee stock purchase plan 610 446 Shares issuable upon conversion of convertible notes 8,110 8,110 18,097 17,474 |
ASU 2016-02 | |
Schedule of Impact on Condensed Consolidated Balance Sheet and Condensed Consolidated Statement of Cash Flows Related to Lease | Topic 840 Topic 842 Impact of Balance Sheet January 1, 2019 January 1, 2019 Adoption Deferred rent classified as accrued liabilities $ (134 ) $ — $ 134 Deferred rent classified as other long-term liabilities (1,015 ) — 1,015 Operating lease right-of-use asset — 14,788 14,788 Lease liability, current — (4,551 ) (4,551 ) Lease liability, non-current $ — $ (11,386 ) $ (11,386 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value of Financial Assets Measured on a Recurring Basis | The following tables set forth the fair value of our financial assets, which consists of investments classified as available-for-sale securities, that were measured on a recurring basis (in thousands): As of June 30, 2019 Fair Value Hierarchy Level Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Financial assets: Money market funds Level 1 $ 23,200 $ — $ — $ 23,200 U.S. Treasury securities Level 1 63,336 57 — 63,393 Corporate debt Level 2 71,701 56 (7 ) 71,750 U.S. Government agency securities Level 2 14,997 7 — 15,004 Commercial paper Level 2 147,731 — — 147,731 Total investments $ 320,965 $ 120 $ (7 ) $ 321,078 As of December 31, 2018 Fair Value Hierarchy Level Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Financial assets: Money market funds Level 1 $ 21,201 $ — $ — $ 21,201 U.S. Treasury securities Level 1 84,098 5 (56 ) 84,047 Corporate debt Level 2 98,367 2 (88 ) 98,281 U.S. Government agency securities Level 2 1,984 — (1 ) 1,983 Commercial paper Level 2 102,781 — — 102,781 Total investments $ 308,431 $ 7 $ (145 ) $ 308,293 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Inventory | Inventory Inventory consists of the following (in thousands): June 30, December 31, 2019 2018 Raw materials $ 11,441 $ 4,140 Work-in process 602 1,019 Finished goods 5,601 3,211 Total inventory $ 17,644 $ 8,370 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): June 30, December 31, 2019 2018 Accrued compensation $ 9,056 $ 12,510 Accrued outside research and development services 4,014 3,431 Accrued professional and consulting services 3,097 3,476 Accrued interest 1,123 1,102 Other 2,739 2,089 Total accrued liabilities $ 20,029 $ 22,608 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Schedule of Undiscounted Future Non-Cancellable Lease Payments under Lease and Sublease | As of June 30, 2019, the undiscounted future non-cancellable lease payments under the Lease and Sublease were as follows (in thousands): Year Ending December 31, 2019 (remainder) $ 1,995 2020 4,918 2021 5,056 2022 1,879 2023 1,936 Thereafter 666 Total undiscounted lease payments 16,450 Less: Present value adjustment (2,609 ) Total $ 13,841 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Debt Disclosure [Abstract] | |
Summary of Minimum Aggregate Future Payment Term Loan | As of June 30, 2019, minimum aggregate future payments under the term loan are as follows (in thousands): 2019 (remainder) $ 1,891 2020 3,763 2021 3,763 2022 3,763 2023 38,521 Total minimum payments $ 51,701 Amount representing interest (16,701 ) Principal amount of term loan $ 35,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock Option Activity under our 2010 Equity Incentive Plan ("2010 Plan"), 2014 Equity Incentive Plan ("2014 EIP") and 2018 Equity Inducement Plan ("2018 Inducement Plan") and Related Information | The following table reflects a summary of stock option activity under our 2010 Equity Incentive Plan (“2010 Plan”), 2014 Equity Incentive Plan (“2014 EIP”) and 2018 Equity Inducement Plan (“2018 Inducement Plan”) Shares Subject to Outstanding Stock Options Weighted- Average Exercise Price Per Share Stock options outstanding at December 31, 2018 6,950 $ 19.06 Stock options granted 1,025 $ 7.61 Stock options exercised (109 ) $ 3.70 Stock options forfeited (442 ) $ 23.38 Stock options outstanding at June 30, 2019 7,424 $ 17.45 |
Summary of Restricted Stock Unit ("RSU") Activity under our 2014 EIP and 2018 Inducement Plan and Related Information | The following table reflects a summary of restricted stock unit (“RSU”) activity under our 2014 EIP and 2018 Inducement Plan and related information for the period from December 31, 2018 through June 30, 2019: Shares Subject to Outstanding RSUs Weighted- Average Grant Date Fair Value Per Share RSUs outstanding at December 31, 2018 1,572 $ 13.50 RSUs granted 1,181 $ 7.17 RSUs vested and settled (557 ) $ 9.51 RSUs forfeited (243 ) $ 10.20 RSUs outstanding at June 30, 2019 1,953 $ 11.22 |
Schedule of Total Stock-Based Compensation Expense | Total stock-based compensation expense related to the 2010 Plan, the 2014 EIP, the 2018 Inducement Plan and the 2014 Employee Stock Purchase Plan Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Cost of sales $ 16 $ — $ 31 $ — Research and development 2,371 2,408 4,831 5,261 Selling, general and administrative 5,123 4,898 10,629 9,559 Total stock-based compensation expense $ 7,510 $ 7,306 $ 15,491 $ 14,820 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019USD ($)customer | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($)customer | Jun. 30, 2018USD ($) | Dec. 31, 2018USD ($) | |
Significant Accounting Policies [Line Items] | |||||
Trade and other receivables, net | $ 59,795,000 | $ 59,795,000 | $ 5,724,000 | ||
Inventory | 17,644,000 | 17,644,000 | 8,370,000 | ||
Inventory finished goods | 5,600,000 | 5,600,000 | |||
Manufacturing purchase commitments, amount | 11,000,000 | $ 11,000,000 | |||
Purchase commitments, period | 12 months | ||||
Revenue related reserve | 3,500,000 | $ 3,500,000 | 2,500,000 | ||
Additional revenue related reserve | 5,200,000 | $ 0 | 12,900,000 | $ 0 | |
Additional revenue related reserve offset by credit or payment | 5,100,000 | 11,900,000 | |||
Advertising expenses | 26,700,000 | $ 14,600,000 | 36,200,000 | $ 21,500,000 | |
Accrued Liabilities | |||||
Significant Accounting Policies [Line Items] | |||||
Revenue related reserve | 2,300,000 | 2,300,000 | 1,800,000 | ||
Trade and Other Receivables | |||||
Significant Accounting Policies [Line Items] | |||||
Revenue related reserve | $ 1,200,000 | $ 1,200,000 | $ 700,000 | ||
Trade Receivable | Customer Concentration Risk | |||||
Significant Accounting Policies [Line Items] | |||||
Customer's accounted for more than 10% of trade receivables and product sales | 99.10% | 99.10% | |||
Number of customers | customer | 3 | 3 | |||
Product Sales | Customer Concentration Risk | |||||
Significant Accounting Policies [Line Items] | |||||
Customer's accounted for more than 10% of trade receivables and product sales | 97.50% | 96.70% | |||
Number of customers | customer | 3 | 3 | |||
Almirall, S.A. | Customer Concentration Risk | |||||
Significant Accounting Policies [Line Items] | |||||
Trade and other receivables, net | $ 50,000 | $ 50,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Common Stock Equivalent Shares Not Included in Computations of Diluted Net Loss per Share (Details) - shares shares in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Anti dilutive securities not included in calculation of EPS | ||
Shares not included in computations of diluted net loss per share | 18,097 | 17,474 |
Employee stock options | ||
Anti dilutive securities not included in calculation of EPS | ||
Shares not included in computations of diluted net loss per share | 7,424 | 7,374 |
Restricted stock units | ||
Anti dilutive securities not included in calculation of EPS | ||
Shares not included in computations of diluted net loss per share | 1,953 | 1,544 |
Convertible Notes | ||
Anti dilutive securities not included in calculation of EPS | ||
Shares not included in computations of diluted net loss per share | 8,110 | 8,110 |
Employee stock | ||
Anti dilutive securities not included in calculation of EPS | ||
Shares not included in computations of diluted net loss per share | 610 | 446 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Impact on Condensed Consolidated Balance Sheet and Condensed Consolidated Statement of Cash Flows Related to Lease (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Leases [Line Items] | |||
Prepaid expenses and other current assets | $ 25,862 | $ 8,275 | |
Deferred rent classified as accrued liabilities | 20,029 | 22,608 | |
Deferred rent classified as other long-term liabilities | $ 1,015 | ||
Operating lease right-of-use asset | 13,144 | ||
Lease liability, current | 4,220 | ||
Lease liability, non-current | $ 9,621 | ||
ASC 840 | |||
Leases [Line Items] | |||
Deferred rent classified as accrued liabilities | $ (134) | ||
Deferred rent classified as other long-term liabilities | (1,015) | ||
ASU 2016-02 | |||
Leases [Line Items] | |||
Operating lease right-of-use asset | 14,788 | ||
Lease liability, current | (4,551) | ||
Lease liability, non-current | (11,386) | ||
ASU 2016-02 | Impact of Adoption | |||
Leases [Line Items] | |||
Deferred rent classified as accrued liabilities | 134 | ||
Deferred rent classified as other long-term liabilities | 1,015 | ||
Operating lease right-of-use asset | 14,788 | ||
Lease liability, current | (4,551) | ||
Lease liability, non-current | $ (11,386) |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Fair value transfers between level 1 and level 2 | ||
Transfer from level 1 to level 2 | $ 0 | $ 0 |
Transfer from level 2 to level 1 | 0 | $ 0 |
Estimate of Fair Value Measurement | Term Loan | ||
Fair value transfers between level 1 and level 2 | ||
Estimated fair value of our term loan | 34,800,000 | |
Estimate of Fair Value Measurement | Level 2 | ||
Fair value transfers between level 1 and level 2 | ||
Estimated fair value of our notes | $ 249,400,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value of Financial Assets Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Financial assets: | ||
Amortized Cost | $ 320,965 | $ 308,431 |
Gross Unrealized Gains | 120 | 7 |
Gross Unrealized Losses | (7) | (145) |
Fair Value | 321,078 | 308,293 |
Money market funds | Level 1 | ||
Financial assets: | ||
Amortized Cost | 23,200 | 21,201 |
Fair Value | 23,200 | 21,201 |
U.S. Treasury securities | Level 1 | ||
Financial assets: | ||
Amortized Cost | 63,336 | 84,098 |
Gross Unrealized Gains | 57 | 5 |
Gross Unrealized Losses | (56) | |
Fair Value | 63,393 | 84,047 |
Corporate debt | Level 2 | ||
Financial assets: | ||
Amortized Cost | 71,701 | 98,367 |
Gross Unrealized Gains | 56 | 2 |
Gross Unrealized Losses | (7) | (88) |
Fair Value | 71,750 | 98,281 |
U.S. Government agency securities | Level 2 | ||
Financial assets: | ||
Amortized Cost | 14,997 | 1,984 |
Gross Unrealized Gains | 7 | |
Gross Unrealized Losses | (1) | |
Fair Value | 15,004 | 1,983 |
Commercial paper | Level 2 | ||
Financial assets: | ||
Amortized Cost | 147,731 | 102,781 |
Fair Value | $ 147,731 | $ 102,781 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 11,441 | $ 4,140 |
Work-in process | 602 | 1,019 |
Finished goods | 5,601 | 3,211 |
Total inventory | $ 17,644 | $ 8,370 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accrued compensation | $ 9,056 | $ 12,510 |
Accrued outside research and development services | 4,014 | 3,431 |
Accrued professional and consulting services | 3,097 | 3,476 |
Accrued interest | 1,123 | 1,102 |
Other | 2,739 | 2,089 |
Total accrued liabilities | $ 20,029 | $ 22,608 |
Leases - Additional Information
Leases - Additional Information (Details) | 3 Months Ended | 6 Months Ended | |||||||
Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jan. 01, 2019USD ($) | Oct. 31, 2017USD ($) | Sep. 30, 2017ft² | Aug. 31, 2014USD ($) | Jul. 31, 2014ft² | |
Operating Leased Assets [Line Items] | |||||||||
Operating lease right-of-use asset | $ 13,144,000 | $ 13,144,000 | |||||||
Aggregate lease liability | 13,841,000 | 13,841,000 | |||||||
Rent expense for Lease and Sublease | 1,600,000 | $ 1,500,000 | 3,200,000 | $ 3,000,000 | |||||
Additional rent charges for common area maintenance and real estate taxes | $ 400,000 | $ 400,000 | $ 800,000 | $ 600,000 | |||||
Sublease Agreement | |||||||||
Operating Leased Assets [Line Items] | |||||||||
Area of office (in square feet) | ft² | 23,798 | ||||||||
Annual increase in base rent (as a percent) | 3.00% | ||||||||
Lease expiration date, subject to renew of lease | Apr. 30, 2024 | ||||||||
Operating lease right-of-use asset | $ 7,200,000 | ||||||||
Aggregate lease liability | $ 7,700,000 | ||||||||
Operating lease, remaining lease term | 5 years 3 months 18 days | ||||||||
Operating lease, discount rate | 9.00% | ||||||||
Lease commencement date | Dec. 20, 2017 | ||||||||
Sublease Agreement | Irrevocable Commercial Letter of Credit | |||||||||
Operating Leased Assets [Line Items] | |||||||||
Irrevocable commercial letter of credit | $ 300,000 | ||||||||
Menlo Park, California | |||||||||
Operating Leased Assets [Line Items] | |||||||||
Area of office (in square feet) | ft² | 45,192 | ||||||||
Annual increase in base rent (as a percent) | 3.00% | 3.00% | |||||||
Lease expiration date, subject to renew of lease | Dec. 31, 2021 | ||||||||
Renewal lease term (in years) | 5 years | 5 years | |||||||
Operating lease right-of-use asset | $ 7,500,000 | ||||||||
Aggregate lease liability | $ 8,200,000 | ||||||||
Operating lease, remaining lease term | 3 years | ||||||||
Operating lease, discount rate | 9.00% | ||||||||
Menlo Park, California | Letter of Credit | |||||||||
Operating Leased Assets [Line Items] | |||||||||
Letter of credit | $ 500,000 | ||||||||
Letter of credit, June 1, 2019, upon no event of default | $ 350,000 | $ 350,000 |
Leases - Schedule of Undiscount
Leases - Schedule of Undiscounted Future Non-Cancellable Lease Payments under Lease and Sublease (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Operating Lease Liabilities Payments Due [Abstract] | |
2019 (remainder) | $ 1,995 |
2020 | 4,918 |
2021 | 5,056 |
2022 | 1,879 |
2023 | 1,936 |
Thereafter | 666 |
Total undiscounted lease payments | 16,450 |
Less: Present value adjustment | (2,609) |
Total | $ 13,841 |
Debt - Additional Information (
Debt - Additional Information (Details) - USD ($) | Aug. 05, 2019 | May 31, 2017 | Jun. 30, 2019 | Jun. 30, 2019 |
Debt Instrument [Line Items] | ||||
Costs and fees relating to issuance of term loan | $ 2,500,000 | |||
Interest Expense | $ 1,000,000 | $ 2,100,000 | ||
Subsequent Event | ||||
Debt Instrument [Line Items] | ||||
Credit Agreement Amendment Fees | $ 350,000 | |||
3.00% Convertible Senior Notes due 2022 | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, interest rate | 3.00% | 3.00% | ||
Unamortized issuance costs and debt discounts | $ 5,400,000 | $ 5,400,000 | ||
Common stock, par value | $ 0.001 | |||
Initial conversion rate of notes | 28.2079 | |||
Principal amount of notes | $ 1,000 | |||
Initial conversion price of stock | $ 35.45 | |||
Percentage of debt instrument redemption price fundamental change | 100.00% | |||
Debt instrument, description | Holders of the Notes may convert all or a portion of their Notes at their option at any time prior to the close of business on the business day immediately prior to May 15, 2022, in multiples of $1,000 principal amount. | |||
3.00% Convertible Senior Notes due 2022 | Private placement | ||||
Debt Instrument [Line Items] | ||||
Aggregate principal amount of notes | $ 287,500,000 | |||
Net proceeds from issuance of convertible notes | 278,300,000 | |||
Debt instrument, issuance costs | 600,000 | |||
Debt instrument, initial purchaser's discounts | $ 8,600,000 | |||
Debt instrument, maturity date | May 15, 2022 | |||
3.00% Convertible Senior Notes due 2022 | Minimum | ||||
Debt Instrument [Line Items] | ||||
Aggregate outstanding principal threshold limit | 60,000,000 | $ 60,000,000 | ||
Term Loan | ||||
Debt Instrument [Line Items] | ||||
Unamortized issuance costs and debt discounts | 2,300,000 | 2,300,000 | ||
Third Tranche | Subsequent Event | ||||
Debt Instrument [Line Items] | ||||
Description of Extended Maturity Date | March 2, 2020 to June 3, 2020 | |||
Senior Secured Term Loan Facility | ||||
Debt Instrument [Line Items] | ||||
Aggregate principal amount | 125,000,000 | $ 125,000,000 | ||
Credit facility interest rate | 10.75% | |||
Line of credit facility, frequency of payment and payment terms | Amounts outstanding under the Credit Agreement bear interest at a rate of 10.75% per year, payable in quarterly in arrears, and provide for interest-only payments followed by payment of principal at maturity in December 2023; provided, however, that if, as of February 13, 2022, the aggregate outstanding principal amount of our 3.00% Convertible Senior Notes due 2022 (“Notes”) is greater than $60.0 million, we must immediately repay all amounts outstanding under the Credit Agreement, together with all accrued and unpaid interest and the applicable prepayment premium, if any. After the occurrence and during the continuation of a default, amounts outstanding will bear interest at a rate of 13.75% per annum, payable in cash quarterly in arrears and on demand. | |||
Line of credit facility, frequency of payments | quarterly | |||
Credit facility maturity year | 2023-12 | |||
Credit facility interest rate during default period | 13.75% | |||
Senior Secured Term Loan Facility | First Tranche | ||||
Debt Instrument [Line Items] | ||||
Aggregate principal amount | 35,000,000 | $ 35,000,000 | ||
Senior Secured Term Loan Facility | Second Tranche | ||||
Debt Instrument [Line Items] | ||||
Aggregate principal amount | 40,000,000 | 40,000,000 | ||
Senior Secured Term Loan Facility | Third Tranche | ||||
Debt Instrument [Line Items] | ||||
Aggregate principal amount | $ 50,000,000 | $ 50,000,000 |
Debt - Summary of Minimum Aggre
Debt - Summary of Minimum Aggregate Future Payment Term Loan (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Debt Disclosure [Abstract] | |
2019 (remainder) | $ 1,891 |
2020 | 3,763 |
2021 | 3,763 |
2022 | 3,763 |
2023 | 38,521 |
Total minimum payments | 51,701 |
Amount representing interest | (16,701) |
Principal amount of term loan | $ 35,000 |
Collaboration and License Agr_2
Collaboration and License Agreements - Roche Agreement (Details) - USD ($) $ in Millions | 1 Months Ended | 6 Months Ended | |||
Feb. 28, 2019 | Jul. 31, 2018 | Oct. 31, 2017 | Jun. 30, 2019 | Nov. 30, 2018 | |
Roche Agreement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Collaborative arrangement and license agreement expiration term, description | Under the terms of the Roche Agreement, as amended, we will also make royalty payments to Roche representing percentages of net sales. Royalty payments will be made from the first commercial sale date in such country and end on the later of the date that is (i) ten years after the date of the first commercial sale of lebrikizumab in such country, (ii) the expiration of the last to expire valid claim of the applicable licensed compound patent rights, our patent rights or joint patent rights in such country covering the use, manufacturing, import, offering for sale, or sale of lebrikizumab in such country, (iii) the expiration of the last to expire valid claim of the applicable licensed non-compound patent rights in such country covering the use, import, offering for sale, or sale of the product in such country, or (iv) the expiration of the last to expire regulatory exclusivity conferred by the applicable regulatory authority in such country for lebrikizumab. | ||||
Amended Roche Agreement | Maximum | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Amount of drug substance to be received free of charge | $ 16 | ||||
Amended Roche Agreement | Achievement of Certain Thresholds for Net Sales of Lebrikizumab | Maximum | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Payments to be made upon achievement of certain milestones | 1,000 | ||||
Development and Commercialization Agreement | Roche Agreement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Initial payment made for licensing agreement | $ 80 | ||||
Payment for execution of agreements | $ 25 | ||||
Additional payments to be made in licensing agreement | $ 30 | ||||
Initiation Of First Phase Three Clinical Study | Amended Roche Agreement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Payments to be made upon achievement of certain milestones | 20 | ||||
Achievement of Certain Thresholds for Net Sales of Lebrikizumab | Roche Agreement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Royalty payment period | 10 years | ||||
Achievement of Certain Thresholds for Net Sales of Lebrikizumab | Amended Roche Agreement | Maximum | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Payments to be made upon achievement of certain milestones | $ 180 |
Collaboration and License Agr_3
Collaboration and License Agreements - Rose U Agreement (Details) - Exclusive License Agreement $ in Millions | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Rose U and Stiefel | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Payment for execution of agreements | $ 4.3 |
Remaining creditable amount | 2.2 |
Rose U | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Additional payment upon the achievement of specified regulatory, commercialization and other milestones | 0.6 |
Payments made under collaborative arrangements | 2.5 |
Accrual royalty payments due | $ 2.5 |
Collaboration and License Agr_4
Collaboration and License Agreements - Almirall Agreement (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jul. 31, 2019 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | $ 66,645 | $ 39,080 | $ 69,097 | $ 39,379 | ||
Deferred revenue, current | 15,075 | 15,075 | ||||
Deferred revenue, non-current | 6,340 | 6,340 | ||||
Collaboration and License Revenue | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | 58,585 | $ 39,080 | 58,585 | $ 39,379 | ||
Option and License Agreement | Almirall, S.A. | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Non-refundable upfront option fee received | $ 30,000 | |||||
Additional milestone payment to be received in connection of initiation of phase 3 clinical studies not constrained | 30,000 | 30,000 | ||||
Transaction price of option | 110,000 | 110,000 | ||||
Deferred revenue, current | 15,100 | 15,100 | ||||
Deferred revenue, non-current | 6,300 | 6,300 | ||||
Option and License Agreement | Almirall, S.A. | Collaboration and License Revenue | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Total revenue | $ 58,600 | $ 58,600 | ||||
Option and License Agreement | Almirall, S.A. | Subsequent Event | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Option exercise fee receivable | $ 50,000 |
Collaboration and License Agr_5
Collaboration and License Agreements - Maruho Agreement (Details) - Maruho G.T. Agreement - Maruho Co. Ltd. - USD ($) | 1 Months Ended | 6 Months Ended | |
Oct. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2019 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Upfront payment received | $ 25,000,000 | ||
Collaborative arrangement and license agreement expiration term, description | Unless earlier terminated, the Maruho Agreement will remain in effect until the later of: (i) expiration or abandonment of the last valid claim of the applicable patent rights in Japan; (ii) expiration of any market exclusivity in Japan granted by the applicable regulatory authority; and (iii) 15 years following the date of the first commercial sale of the drug product in Japan. | ||
Collaborative arrangement and license agreement expiration term of first commercial sale | 15 years | ||
Maximum | |||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||
Addition payment to be received upon achievement of certain milestones | $ 70,000,000 |
Collaboration and License Agr_6
Collaboration and License Agreements - UCB Agreement (Details) - USD ($) | Nov. 06, 2017 | Mar. 31, 2014 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Total revenue | $ 66,645,000 | $ 39,080,000 | $ 69,097,000 | $ 39,379,000 | |||
Collaboration and License Revenue | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Total revenue | $ 58,585,000 | 39,080,000 | $ 58,585,000 | 39,379,000 | |||
Development and Commercialization Agreement | UCB | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Agreement date | Mar. 21, 2014 | ||||||
Agreement termination date | Feb. 15, 2018 | ||||||
Development and Commercialization Agreement and Transition Agreement | UCB | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Termination or penalty payments | $ 0 | ||||||
Payment to be received in consideration for repurchase of rights | 11,000,000 | ||||||
Additional payment to be received in consideration for repurchase of rights | 39,000,000 | 39,000,000 | |||||
Reimbursement of development costs incurred | $ 10,000,000 | ||||||
Reimbursement of development costs description | We were obligated to reimburse UCB for up to $10.0 million of development costs incurred by UCB in connection with the development of Cimzia between January 1, 2018 and June 30, 2018. | ||||||
Collaborative arrangement,fully reimbursement | $ 10,000,000 | ||||||
Development and Commercialization Agreement and Transition Agreement | UCB | Collaboration and License Revenue | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Total revenue | $ 39,100,000 | $ 39,400,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity under our 2010 Equity Incentive Plan ("2010 Plan"), 2014 Equity Incentive Plan ("2014 EIP") and 2018 Equity Inducement Plan ("2018 Inducement Plan") and Related Information (Details) - Stock Options - 2010 Equity Incentive Plan ("2010 Plan"), 2014 Equity Incentive Plan ("2014 EIP") and 2018 Equity Inducement Plan ("2018 Inducement Plan") shares in Thousands | 6 Months Ended |
Jun. 30, 2019$ / sharesshares | |
Shares Subject to Outstanding Stock Options | |
Stock options outstanding (in shares) | shares | 6,950 |
Stock options granted (in shares) | shares | 1,025 |
Stock options exercised (in shares) | shares | (109) |
Stock options forfeited (in shares) | shares | (442) |
Stock options outstanding (in shares) | shares | 7,424 |
Weighted-Average Exercise Price Per Share | |
Stock options outstanding (in dollars per share) | $ / shares | $ 19.06 |
Stock options granted (in dollars per share) | $ / shares | 7.61 |
Stock options exercised (in dollars per share) | $ / shares | 3.70 |
Stock options forfeited (in dollars per share) | $ / shares | 23.38 |
Stock options outstanding (in dollars per share | $ / shares | $ 17.45 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Unit ("RSU") Activity under our 2014 EIP and 2018 Inducement Plan and Related Information (Details) - Restricted stock units - 2014 EIP and 2018 Inducement Plan shares in Thousands | 6 Months Ended |
Jun. 30, 2019$ / sharesshares | |
Shares Subject to Outstanding RSUs | |
RSUs outstanding at the beginning of the period (in shares) | shares | 1,572 |
RSUs granted (in shares) | shares | 1,181 |
RSUs vested and settled | shares | (557) |
RSUs forfeited (in shares) | shares | (243) |
RSUs outstanding at the end of the period (in shares) | shares | 1,953 |
Weighted-Average Grant Date Fair Value | |
RSUs outstanding at the beginning of the period (in dollars per share) | $ / shares | $ 13.50 |
RSUs granted (in dollars per share) | $ / shares | 7.17 |
RSUs vested and settled | $ / shares | 9.51 |
RSUs forfeited (in dollars per share) | $ / shares | 10.20 |
RSUs outstanding at the end of the period (in dollars per share) | $ / shares | $ 11.22 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Total Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | $ 7,510 | $ 7,306 | $ 15,491 | $ 14,820 |
Cost of sales | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | 16 | 31 | ||
Research and development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | 2,371 | 2,408 | 4,831 | 5,261 |
Selling, general and administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation expense | $ 5,123 | $ 4,898 | $ 10,629 | $ 9,559 |
Stock-Based Compensation - Tota
Stock-Based Compensation - Total Stock-Based Compensation - General Disclosures (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019 | Jun. 30, 2019 | |
Inventory | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation capitalized | $ 0.1 | $ 0.2 |