Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2018 | Apr. 30, 2018 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | Dermira, Inc. | |
Trading Symbol | DERM | |
Entity Central Index Key | 1,557,883 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2018 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 41,847,981 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q1 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 288,568 | $ 295,923 |
Short-term investments | 207,225 | 255,070 |
Collaboration receivables | 57 | 52 |
Prepaid expenses and other current assets | 6,237 | 5,569 |
Total current assets | 502,087 | 556,614 |
Property and equipment, net | 1,500 | 1,433 |
Intangible assets | 1,126 | |
Goodwill | 771 | 771 |
Restricted cash | 801 | 800 |
Other assets | 698 | 50 |
Total assets | 505,857 | 560,794 |
Current liabilities: | ||
Accounts payable | 10,580 | 15,094 |
Accrued liabilities | 24,616 | 25,115 |
Refund liability | 10,000 | 10,000 |
Accrued payments related to acquired in-process research and development | 51,802 | 50,161 |
Deferred revenue, current | 80 | 4,988 |
Total current liabilities | 97,078 | 105,358 |
Long-term liabilities: | ||
Deferred revenue, non-current | 25,286 | |
Convertible notes, net | 279,847 | 279,389 |
Deferred tax liability | 194 | |
Other long-term liabilities | 1,059 | 918 |
Total liabilities | 377,984 | 411,145 |
Stockholders’ equity: | ||
Common stock | 42 | 42 |
Additional paid-in capital | 710,926 | 703,215 |
Accumulated other comprehensive loss | (343) | (215) |
Accumulated deficit | (582,752) | (553,393) |
Total stockholders’ equity | 127,873 | 149,649 |
Total liabilities and stockholders’ equity | $ 505,857 | $ 560,794 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenue: | ||
Collaboration and license revenue | $ 299 | $ 1,066 |
Operating expenses: | ||
Research and development | 25,591 | 19,860 |
General and administrative | 30,510 | 11,326 |
Impairment of intangible assets | 1,126 | |
Total operating expenses | 57,227 | 31,186 |
Loss from operations | (56,928) | (30,120) |
Interest and other income, net | 1,734 | 611 |
Interest expense | (4,254) | |
Loss before taxes | (59,448) | (29,509) |
Benefit for income taxes | 194 | |
Net loss | $ (59,254) | $ (29,509) |
Net loss per share, basic and diluted | $ (1.42) | $ (0.79) |
Weighted-average common shares used to compute net loss per share, basic and diluted | 41,827 | 37,290 |
CONDENSED CONSOLIDATED STATEME4
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (59,254) | $ (29,509) |
Other comprehensive income (loss): | ||
Unrealized gain (loss) on available-for-sale securities | (128) | 77 |
Total comprehensive loss | $ (59,382) | $ (29,432) |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Cash flows from operating activities | ||
Net loss | $ (59,254) | $ (29,509) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 115 | 81 |
Stock-based compensation | 7,514 | 4,615 |
Amortization of discount for payments related to acquired in-process research and development | 1,641 | |
Net amortization of premiums on available-for-sale securities | 280 | 610 |
Amortization of convertible note discount and issuance costs | 458 | |
Impairment of intangible assets | 1,126 | |
Changes in assets and liabilities: | ||
Collaboration receivables | (5) | 10,700 |
Prepaid expenses and other current assets | (507) | 3,025 |
Other assets | (648) | 22 |
Accounts payable | (4,351) | (8,094) |
Accrued liabilities | (809) | (5,598) |
Other long-term liabilities | 141 | 191 |
Deferred revenue | (299) | (1,066) |
Deferred taxes | (194) | |
Net cash used in operating activities | (54,792) | (25,023) |
Cash flows from investing activities | ||
Purchases of available-for-sale securities | (48,874) | (55,222) |
Maturities of available-for-sale securities | 96,150 | 57,861 |
Purchase of property and equipment | (35) | (35) |
Net cash provided by investing activities | 47,241 | 2,604 |
Cash flows from financing activities | ||
Net proceeds from issuance of common stock in connection with equity financings | 182,543 | |
Net proceeds from issuance of common stock in connection with equity awards | 197 | |
Net cash provided by financing activities | 197 | 182,543 |
Net increase (decrease) in cash and cash equivalents and restricted cash | (7,354) | 160,124 |
Cash and cash equivalents and restricted cash at beginning of year | 296,723 | 42,293 |
Cash and cash equivalents and restricted cash at end of period | $ 289,369 | $ 202,417 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2018 | |
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 and develop leading-edge medical dermatology clinical programs. Our pipeline includes two late-stage product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate (formerly DRM04), for which a New Drug Application is under review by the U.S. Food and Drug Administration (“FDA”) for the treatment of primary axillary hyperhidrosis (excessive underarm sweating beyond what is needed for normal body temperature regulation); and lebrikizumab, in Phase 2b development for the treatment of moderate-to-severe atopic dermatitis. We are headquartered in Menlo Park, California. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2018 | |
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-month period ended March 31, 2018 are not necessarily indicative of the results to be expected for the full year ending December 31, 2018 or any other future period. The condensed consolidated balance sheet as of December 31, 2017 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. See “ Recent Accounting Pronouncements ” below for discussion of our adoption of the new revenue recognition guidance. 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, 2017 included in our Annual Report on Form 10-K, filed with the SEC on February 22, 2018. 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, acquired in-process research and development, investments, accrued research and development expenses, goodwill, 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 primarily consists of letters of credit collateralized by a money market account pursuant to certain lease agreements. Cash and cash equivalents and restricted cash as reported within the condensed consolidated statements of cash flows for the three months ended March 31, 2018 and 2017 consisted of the following (in thousands): Three Months Ended March 31, 2018 Three Months Ended March 31, 2017 Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 295,923 $ 288,568 $ 41,793 $ 201,917 Restricted cash 800 801 500 500 Cash and cash equivalents and restricted cash as reported per statement of cash flows $ 296,723 $ 289,369 $ 42,293 $ 202,417 Revenue Recognition Effective January 1, 2018, we adopted Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606) (“Topic 606” or “ASU 2014-09”) Revenue Recognition The following paragraphs in this section describe our revenue recognition accounting polices under Topic 606 upon adoption on January 1, 2018. Refer to Note 2 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2017 for revenue recognition accounting policies under Topic 605. 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 Collaborative Arrangements We enter into collaborative arrangements with partners that typically include payment to us of one of more of the following: (i) license fees; (ii) milestone payments related to the achievement of developmental, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Where 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. 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. 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. 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. 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 March 31, 2018 2017 Stock options to purchase common stock 7,387 5,461 Shares subject to outstanding restricted stock units 574 348 Estimated shares issuable under the employee stock purchase plan 193 61 Shares issuable upon conversion of convertible notes 8,110 — 16,264 5,870 Recent Accounting Pronouncements In November 2016, the Financial Accounting Standards Board (“FASB”) issued ASU Statement of Cash Flows (Topic 230): Restricted Cash In February 2016, the issued ASU Leases We expect the implementation of Topic 842 to have an impact on our consolidated financial statements and related disclosures as we had aggregate future minimum lease payments of approximately $22.7 million as of March 31, 2018. We anticipate recognition of additional assets and corresponding liabilities related to these leases on our consolidated balance sheet. As noted above, effective January 1, 2018, we adopted Topic 606. Since ASU 2014-09 was issued, several additional ASUs have been issued and incorporated within Topic 606 to clarify various elements of the guidance. As part of our adoption efforts, we have completed the assessment of our collaboration and license agreements under Topic 606. We adopted Topic 606 in the first quarter of 2018 using the modified retrospective method which consists of applying and recognizing the cumulative effect of Topic 606 at the date of initial application and providing certain additional disclosures as defined per Topic 606. On January 1, 2018, we recorded a cumulative adjustment to decrease deferred revenue and accumulated deficit by approximately $29.9 million, to reflect the impact of the adoption of Topic 606. The cumulative adjustment relates primarily to our agreements with Maruho Co., Ltd. (“Maruho”) which are described further in Note 7 Collaboration and License Agreements. Below is a summary of the affected line items of the condensed consolidated balance sheets upon adoption of Topic 606 (in thousands): Balance at December 31, 2017 Adjustments due to Topic 606 Balance at January 1, 2018 Balance Sheet Deferred revenue, current $ 4,988 $ (4,609 ) $ 379 Deferred revenue, non-current 25,286 (25,286 ) — Accumulated deficit $ (553,393 ) $ 29,895 $ (523,498 ) As a result of adopting Topic 606 on January 1, 2018 under the modified retrospective method, we did not revise the comparative financial statements for the prior years as if Topic 606 had been effective for those periods. Below is disclosure of what our collaboration and license revenue would have been in the three months ended March 31, 2018 under Topic 605 (in thousands): For the period ended March 31, 2018 As Reported Amount under Topic 605 Effect of Change Statement of Operations Collaboration and license revenue $ 299 $ 1,518 $ (1,219 ) The adoption of Topic 606 did not have a significant impact on our net loss per share. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2018 | |
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 transfers between Level 1 and Level 2 during the periods presented. 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 March 31, 2018 Fair Value Hierarchy Level Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Financial assets: Money market funds Level 1 $ 208,455 $ — $ — $ 208,455 U.S. Treasury securities Level 1 7,975 — (12 ) 7,963 Corporate debt Level 2 156,200 — (299 ) 155,901 Repurchase agreements Level 2 42,500 — — 42,500 U.S. Government agency securities Level 2 23,565 — (32 ) 23,533 Commercial paper Level 2 54,973 — — 54,973 Total investments $ 493,668 $ — $ (343 ) $ 493,325 As of December 31, 2017 Fair Value Hierarchy Level Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Financial assets: Money market funds Level 1 $ 187,649 $ — $ — $ 187,649 U.S. Treasury securities Level 1 13,968 — (5 ) 13,963 Corporate debt Level 2 189,287 2 (194 ) 189,095 Repurchase agreements Level 2 60,500 — — 60,500 U.S. Government agency securities Level 2 25,466 — (18 ) 25,448 Commercial paper Level 2 71,864 — — 71,864 Total investments $ 548,734 $ 2 $ (217 ) $ 548,519 As of March 31, 2018, we did not hold any investments with a maturity exceeding one year. 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 March 31, 2018 were temporary in nature. The estimated fair value of our Notes was $227.9 million as of March 31, 2018 and was based upon observable, Level 2 inputs, including pricing information from recent trades of the Notes as of March 31, 2018. See Note 7 for information relating to payments which were measured using unobservable, Level 3 inputs, including a discount rate. |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Mar. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | 4. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): March 31, December 31, 2018 2017 Accrued outside research and development services $ 9,518 $ 9,065 Accrued compensation 5,313 9,427 Accrued professional and consulting services 6,236 4,411 Accrued interest 3,258 1,102 Other 291 1,110 Total accrued liabilities $ 24,616 $ 25,115 |
Impairment of In-Process Resear
Impairment of In-Process Research and Development | 3 Months Ended |
Mar. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Impairment of In-Process Research and Development | 5. Impairment of in-process research and development In connection with the acquisition of Valocor Therapeutics, Inc. (“Valocor”) in 2011, we acquired intangible assets that were associated with in-process research and development (“IPR&D”) projects relating to preclinical product candidates. These assets are considered to be indefinite‑lived and are not amortized, but are tested for impairment on an annual basis, as well as between annual tests if there are changes in circumstances that would indicate a reduction in the fair value of the IPR&D projects below their respective carrying amounts. If and when development is complete, the associated assets would be deemed finite‑lived and would then be amortized based on their respective estimated useful lives. In March 2018, we received results that the investigational treatment olumacostat glasaretil (formerly DRM01) did not meet the co-primary endpoints in its two Phase 3 pivotal trials (CLAREOS-1 and CLAREOS-2) in patients ages nine years and older with moderate-to-severe acne vulgaris. W |
Convertible Notes
Convertible Notes | 3 Months Ended |
Mar. 31, 2018 | |
Debt Disclosure [Abstract] | |
Convertible Notes | 6. Convertible Notes In May 2017, we sold $287.5 million aggregate principal amount of 3.00% Convertible Senior Notes due 2022 (“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 March 31, 2018, there were unamortized issuance costs and debt discounts of $7.7 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 | 3 Months Ended |
Mar. 31, 2018 | |
Collaboration And License Agreements [Abstract] | |
Collaboration and License Agreements | 7. Collaboration and License Agreements Maruho Agreements In March 2013, we entered into a Right of First Negotiation Agreement with Maruho Co., Ltd. (“Maruho Right of First Negotiation Agreement”), pursuant to which we provided Maruho with certain information and the right to negotiate an exclusive license to develop and commercialize certain of our products in specified territories. In connection with the entry into this agreement, Maruho paid us $10.0 million (“Maruho Payment”), which would be credited against certain payments payable by Maruho to us if we were to enter into a license agreement for any of our products. Maruho’s right of first negotiation expired in December 2016 but the right to credit the Maruho Payment against certain payments under any future license agreement for our products remains. W e concluded that there are no remaining performance obligations under Topic 606 as of the date of the adoption. As a result, a cumulative adjustment to reduce deferred revenue of $10.0 million was recorded upon the adoption of Topic 606 on January 1, 2018. In September 2016, we entered into an Exclusive License Agreement with Maruho, which grants Maruho an exclusive license to develop and commercialize glycopyrronium tosylate for the treatment of hyperhidrosis in Japan (“Maruho G.T. Agreement”). Pursuant to the terms of the Maruho G.T. 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 G.T. 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. The Maruho G.T. Agreement is unrelated to, and the exclusive license of glycopyrronium tosylate in Japan to Maruho was not subject to the terms of, the existing Maruho Right of First Negotiation Agreement. Under Topic 606, we evaluated the terms of the Maruho G.T. 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 G.T. Agreement will remain in effect until the later of: (1) expiration or abandonment of the last valid claim of the applicable patent rights in Japan; (2) expiration of any market exclusivity in Japan granted by the applicable regulatory authority; and (3) 15 years following the date of the first commercial sale of the drug product in Japan. Under Topic 606, the entire transaction price of $25.0 million was allocated to the license performance obligation. The license was deemed to be delivered in 2016 in connection with the execution of the agreement and the performance obligation was fully satisfied. As a result, a cumulative adjustment to reduce deferred revenue of $19.6 million was recorded upon the adoption of Topic 606 on January 1, 2018. 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 FDA, the European Medicines Agency and the Canadian federal department for health, and (b) upon the grant of regulatory approval in the United States and Canada, promote sales of Cimzia to dermatologists and conduct related medical affairs activities in the United States and Canada. The UCB Agreement also provided either party with the right to terminate the agreement under certain terms. We expressed our intent to terminate the UCB Agreement in accordance with its terms. 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, upon approval of Cimzia in psoriasis in the United States, will pay us an additional $39.0 million within 30 days of such approval. We are 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. If the aggregate development costs reimbursed by us to UCB during this six-month period are less than $10.0 million, we will pay UCB the difference between such aggregate costs and $10.0 million. These terms replace the provisions of the UCB Agreement pursuant to which we would have been eligible to recoup our external development costs incurred related to the Cimzia program, net of milestones received, through a royalty on future net sales of Cimzia. The $10.0 million payable to UCB is recorded on our consolidated balance sheets as refund liability. Under Topic 606, we evaluated the terms of the Transition Agreement and the transition services were identified as the only performance obligation as of the inception of the agreement. We further determined that the transaction price under the arrangement was comprised of $1.0 million, representing the net consideration from the $11.0 million payment received from UCB and the $10.0 million refund liability due to UCB. The future potential $39.0 million milestone amount was not included in the transaction price, as it was determined to be constrained . For the three months ended March 31, 2018, we recognized $0.3 million in revenue in our condensed consolidated statement of operations related to UCB. 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”) Under the terms of the Roche Agreement, we made an initial payment of $80.0 million to Roche in October 2017 and will make additional payments to Roche in 2018 totaling $55.0 million. We will also be obligated to make payments upon the achievement of certain milestones, comprising $40.0 million upon the initiation of the first Phase 3 clinical study, up to $210.0 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 indications other than interstitial lung disease. Upon regulatory approval, if obtained, we will make royalty payments representing percentages of net sales that range from the high single-digits to the high teens. Royalty payments will be made from the first commercial sale date in a country (other than for the Retained Field) in such country and end on the later of the date that is (a) ten years after the date of the first commercial sale of lebrikizumab (other than for the Retained Field) in such country, (b) the expiration of the last to expire valid claim of the applicable licensed compound patent rights, Dermira patent rights or joint patent rights in such country covering the use, manufacturing, import, offering for sale, or sale of lebrikizumab (other than for the Retained Field) in such country, (c) 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 (d) the expiration of the last to expire regulatory exclusivity conferred by the applicable regulatory authority in such country for lebrikizumab (other than for the Retained Field). We determined that the acquired IPR&D related to the Roche Agreement had no alternative future use and recorded an expense of $128.6 million during the year ended December 31, 2017 in the consolidated statements of operations as acquired in-process research and development expense related to acquired in-process research and development, current, for the $25.0 million and $30.0 million payments due by September 2018 and December 2018, respectively. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2018 | |
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, 2017 6,022 $ 19.15 Stock options granted 1,541 $ 27.33 Stock options exercised (44 ) $ 4.48 Stock options forfeited (132 ) $ 28.53 Stock options outstanding at March 31, 2018 7,387 $ 20.78 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, 2017 through March 31, 2018: Shares Subject to Outstanding RSUs Weighted- Average Grant Date Fair Value Per Share RSUs outstanding at December 31, 2017 296 $ 30.81 RSUs granted 301 $ 27.60 RSUs vested and settled (6 ) $ 28.61 RSUs forfeited (16 ) $ 30.37 RSUs outstanding at March 31, 2018 575 $ 29.16 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 March 31, 2018 2017 Research and development $ 2,853 $ 1,796 General and administrative 4,661 2,819 Total stock-based compensation expense $ 7,514 $ 4,615 |
Summary of Significant Accoun14
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2018 | |
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-month period ended March 31, 2018 are not necessarily indicative of the results to be expected for the full year ending December 31, 2018 or any other future period. The condensed consolidated balance sheet as of December 31, 2017 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. See “ Recent Accounting Pronouncements ” below for discussion of our adoption of the new revenue recognition guidance. 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, 2017 included in our Annual Report on Form 10-K, filed with the SEC on February 22, 2018. |
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, acquired in-process research and development, investments, accrued research and development expenses, goodwill, 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 Restricted cash primarily consists of letters of credit collateralized by a money market account pursuant to certain lease agreements. Cash and cash equivalents and restricted cash as reported within the condensed consolidated statements of cash flows for the three months ended March 31, 2018 and 2017 consisted of the following (in thousands): Three Months Ended March 31, 2018 Three Months Ended March 31, 2017 Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 295,923 $ 288,568 $ 41,793 $ 201,917 Restricted cash 800 801 500 500 Cash and cash equivalents and restricted cash as reported per statement of cash flows $ 296,723 $ 289,369 $ 42,293 $ 202,417 |
Revenue Recognition | Revenue Recognition Effective January 1, 2018, we adopted Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (Topic 606) (“Topic 606” or “ASU 2014-09”) Revenue Recognition The following paragraphs in this section describe our revenue recognition accounting polices under Topic 606 upon adoption on January 1, 2018. Refer to Note 2 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2017 for revenue recognition accounting policies under Topic 605. 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 Collaborative Arrangements We enter into collaborative arrangements with partners that typically include payment to us of one of more of the following: (i) license fees; (ii) milestone payments related to the achievement of developmental, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Where 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. 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. 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. 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. |
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 March 31, 2018 2017 Stock options to purchase common stock 7,387 5,461 Shares subject to outstanding restricted stock units 574 348 Estimated shares issuable under the employee stock purchase plan 193 61 Shares issuable upon conversion of convertible notes 8,110 — 16,264 5,870 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2016, the Financial Accounting Standards Board (“FASB”) issued ASU Statement of Cash Flows (Topic 230): Restricted Cash In February 2016, the issued ASU Leases We expect the implementation of Topic 842 to have an impact on our consolidated financial statements and related disclosures as we had aggregate future minimum lease payments of approximately $22.7 million as of March 31, 2018. We anticipate recognition of additional assets and corresponding liabilities related to these leases on our consolidated balance sheet. As noted above, effective January 1, 2018, we adopted Topic 606. Since ASU 2014-09 was issued, several additional ASUs have been issued and incorporated within Topic 606 to clarify various elements of the guidance. As part of our adoption efforts, we have completed the assessment of our collaboration and license agreements under Topic 606. We adopted Topic 606 in the first quarter of 2018 using the modified retrospective method which consists of applying and recognizing the cumulative effect of Topic 606 at the date of initial application and providing certain additional disclosures as defined per Topic 606. On January 1, 2018, we recorded a cumulative adjustment to decrease deferred revenue and accumulated deficit by approximately $29.9 million, to reflect the impact of the adoption of Topic 606. The cumulative adjustment relates primarily to our agreements with Maruho Co., Ltd. (“Maruho”) which are described further in Note 7 Collaboration and License Agreements. Below is a summary of the affected line items of the condensed consolidated balance sheets upon adoption of Topic 606 (in thousands): Balance at December 31, 2017 Adjustments due to Topic 606 Balance at January 1, 2018 Balance Sheet Deferred revenue, current $ 4,988 $ (4,609 ) $ 379 Deferred revenue, non-current 25,286 (25,286 ) — Accumulated deficit $ (553,393 ) $ 29,895 $ (523,498 ) As a result of adopting Topic 606 on January 1, 2018 under the modified retrospective method, we did not revise the comparative financial statements for the prior years as if Topic 606 had been effective for those periods. Below is disclosure of what our collaboration and license revenue would have been in the three months ended March 31, 2018 under Topic 605 (in thousands): For the period ended March 31, 2018 As Reported Amount under Topic 605 Effect of Change Statement of Operations Collaboration and license revenue $ 299 $ 1,518 $ (1,219 ) The adoption of Topic 606 did not have a significant impact on our net loss per share. |
Summary of Significant Accoun15
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Summary of Cash and Cash Equivalents and Restricted Cash as Reported within Condensed Consolidated Statements of Cash Flows | Cash and cash equivalents and restricted cash as reported within the condensed consolidated statements of cash flows for the three months ended March 31, 2018 and 2017 consisted of the following (in thousands): Three Months Ended March 31, 2018 Three Months Ended March 31, 2017 Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 295,923 $ 288,568 $ 41,793 $ 201,917 Restricted cash 800 801 500 500 Cash and cash equivalents and restricted cash as reported per statement of cash flows $ 296,723 $ 289,369 $ 42,293 $ 202,417 |
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 March 31, 2018 2017 Stock options to purchase common stock 7,387 5,461 Shares subject to outstanding restricted stock units 574 348 Estimated shares issuable under the employee stock purchase plan 193 61 Shares issuable upon conversion of convertible notes 8,110 — 16,264 5,870 |
ASU 2014-09 | |
Summary of Affected Line Items of Condensed Consolidated Balance Sheets upon Adoption of Topic 606 and Disclosure of Collaboration and License Revenue | Below is a summary of the affected line items of the condensed consolidated balance sheets upon adoption of Topic 606 (in thousands): Balance at December 31, 2017 Adjustments due to Topic 606 Balance at January 1, 2018 Balance Sheet Deferred revenue, current $ 4,988 $ (4,609 ) $ 379 Deferred revenue, non-current 25,286 (25,286 ) — Accumulated deficit $ (553,393 ) $ 29,895 $ (523,498 ) As a result of adopting Topic 606 on January 1, 2018 under the modified retrospective method, we did not revise the comparative financial statements for the prior years as if Topic 606 had been effective for those periods. Below is disclosure of what our collaboration and license revenue would have been in the three months ended March 31, 2018 under Topic 605 (in thousands): For the period ended March 31, 2018 As Reported Amount under Topic 605 Effect of Change Statement of Operations Collaboration and license revenue $ 299 $ 1,518 $ (1,219 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value of Financial Instruments that were 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 March 31, 2018 Fair Value Hierarchy Level Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Financial assets: Money market funds Level 1 $ 208,455 $ — $ — $ 208,455 U.S. Treasury securities Level 1 7,975 — (12 ) 7,963 Corporate debt Level 2 156,200 — (299 ) 155,901 Repurchase agreements Level 2 42,500 — — 42,500 U.S. Government agency securities Level 2 23,565 — (32 ) 23,533 Commercial paper Level 2 54,973 — — 54,973 Total investments $ 493,668 $ — $ (343 ) $ 493,325 As of December 31, 2017 Fair Value Hierarchy Level Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Financial assets: Money market funds Level 1 $ 187,649 $ — $ — $ 187,649 U.S. Treasury securities Level 1 13,968 — (5 ) 13,963 Corporate debt Level 2 189,287 2 (194 ) 189,095 Repurchase agreements Level 2 60,500 — — 60,500 U.S. Government agency securities Level 2 25,466 — (18 ) 25,448 Commercial paper Level 2 71,864 — — 71,864 Total investments $ 548,734 $ 2 $ (217 ) $ 548,519 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): March 31, December 31, 2018 2017 Accrued outside research and development services $ 9,518 $ 9,065 Accrued compensation 5,313 9,427 Accrued professional and consulting services 6,236 4,411 Accrued interest 3,258 1,102 Other 291 1,110 Total accrued liabilities $ 24,616 $ 25,115 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock Option Activitty 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, 2017 6,022 $ 19.15 Stock options granted 1,541 $ 27.33 Stock options exercised (44 ) $ 4.48 Stock options forfeited (132 ) $ 28.53 Stock options outstanding at March 31, 2018 7,387 $ 20.78 |
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, 2017 through March 31, 2018: Shares Subject to Outstanding RSUs Weighted- Average Grant Date Fair Value Per Share RSUs outstanding at December 31, 2017 296 $ 30.81 RSUs granted 301 $ 27.60 RSUs vested and settled (6 ) $ 28.61 RSUs forfeited (16 ) $ 30.37 RSUs outstanding at March 31, 2018 575 $ 29.16 |
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 March 31, 2018 2017 Research and development $ 2,853 $ 1,796 General and administrative 4,661 2,819 Total stock-based compensation expense $ 7,514 $ 4,615 |
Organization - Additional Infor
Organization - Additional Information (Details) | Mar. 31, 2018product |
Organization | |
Number of late-stage product candidates | 2 |
Summary of Significant Accoun20
Summary of Significant Accounting Policies - Summary of Cash and Cash Equivalents and Restricted Cash as Reported within Condensed Consolidated Statements of Cash Flows (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 | Mar. 31, 2017 | Dec. 31, 2016 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 288,568 | $ 295,923 | $ 201,917 | $ 41,793 |
Restricted cash | 801 | 800 | 500 | 500 |
Cash and cash equivalents and restricted cash as reported per statement of cash flows | $ 289,369 | $ 296,723 | $ 202,417 | $ 42,293 |
Summary of Significant Accoun21
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 | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Anti dilutive securities not included in calculation of EPS | ||
Shares not included in computations of diluted net loss per share | 16,264 | 5,870 |
Employee stock options | ||
Anti dilutive securities not included in calculation of EPS | ||
Shares not included in computations of diluted net loss per share | 7,387 | 5,461 |
Restricted stock units | ||
Anti dilutive securities not included in calculation of EPS | ||
Shares not included in computations of diluted net loss per share | 574 | 348 |
Convertible Notes | ||
Anti dilutive securities not included in calculation of EPS | ||
Shares not included in computations of diluted net loss per share | 8,110 | |
Employee stock | ||
Anti dilutive securities not included in calculation of EPS | ||
Shares not included in computations of diluted net loss per share | 193 | 61 |
Summary of Significant Accoun22
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Significant Accounting Policies [Line Items] | |||
Accumulated deficit | $ (582,752) | $ (553,393) | |
ASU 2016-02 | |||
Significant Accounting Policies [Line Items] | |||
Aggregate future minimum lease payments | $ 22,700 | ||
ASU 2014-09 | |||
Significant Accounting Policies [Line Items] | |||
Accumulated deficit | $ (523,498) | ||
ASU 2014-09 | Adjustments due to Topic 606 | |||
Significant Accounting Policies [Line Items] | |||
Deferred revenue | (29,900) | ||
Accumulated deficit | $ 29,895 |
Summary of Significant Accoun23
Summary of Significant Accounting Policies - Summary of Affected Line Items of Condensed Consolidated Balance Sheets upon Adoption of Topic 606 (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Deferred revenue, current | $ 80 | $ 4,988 | |
Deferred revenue, non-current | 25,286 | ||
Accumulated deficit | $ (582,752) | $ (553,393) | |
ASU 2014-09 | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Deferred revenue, current | $ 379 | ||
Accumulated deficit | (523,498) | ||
ASU 2014-09 | Adjustments due to Topic 606 | |||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | |||
Deferred revenue, current | (4,609) | ||
Deferred revenue, non-current | (25,286) | ||
Accumulated deficit | $ 29,895 |
Summary of Significant Accoun24
Summary of Significant Accounting Policies - Disclosure of Collaboration and License Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||
Collaboration and license revenue | $ 299 | $ 1,066 |
ASU 2014-09 | Amount under Topic 605 | ||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||
Collaboration and license revenue | 1,518 | |
ASU 2014-09 | Effect of Change | ||
Revenue Initial Application Period Cumulative Effect Transition [Line Items] | ||
Collaboration and license revenue | $ (1,219) |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | Mar. 31, 2018 | Dec. 31, 2017 |
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 | Level 2 | ||
Fair value transfers between level 1 and level 2 | ||
Estimated fair value of our notes | $ 227,900,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value of Financial Instruments that were Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Financial assets: | ||
Amortized Cost | $ 493,668 | $ 548,734 |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | (343) | (217) |
Available-for-sale securities | 493,325 | 548,519 |
Money market funds | Level 1 | ||
Financial assets: | ||
Amortized Cost | 208,455 | 187,649 |
Available-for-sale securities | 208,455 | 187,649 |
U.S. Treasury securities | Level 1 | ||
Financial assets: | ||
Amortized Cost | 7,975 | 13,968 |
Gross Unrealized Losses | (12) | (5) |
Available-for-sale securities | 7,963 | 13,963 |
Corporate debt | Level 2 | ||
Financial assets: | ||
Amortized Cost | 156,200 | 189,287 |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | (299) | (194) |
Available-for-sale securities | 155,901 | 189,095 |
Repurchase agreements | Level 2 | ||
Financial assets: | ||
Amortized Cost | 42,500 | 60,500 |
Available-for-sale securities | 42,500 | 60,500 |
U.S. Government agency securities | Level 2 | ||
Financial assets: | ||
Amortized Cost | 23,565 | 25,466 |
Gross Unrealized Losses | (32) | (18) |
Available-for-sale securities | 23,533 | 25,448 |
Commercial paper | Level 2 | ||
Financial assets: | ||
Amortized Cost | 54,973 | 71,864 |
Available-for-sale securities | $ 54,973 | $ 71,864 |
Accrued Liabilities- Schedule o
Accrued Liabilities- Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Accrued outside research and development services | $ 9,518 | $ 9,065 |
Accrued compensation | 5,313 | 9,427 |
Accrued professional and consulting services | 6,236 | 4,411 |
Accrued interest | 3,258 | 1,102 |
Other | 291 | 1,110 |
Total accrued liabilities | $ 24,616 | $ 25,115 |
Impairment of In-Process Rese28
Impairment of In-Process Research and Development - Additional Information (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Acquired Indefinite Lived Intangible Assets [Line Items] | |
Impairment of intangible assets, indefinite-lived | $ 1,126 |
Indefinite Lived Assets In-Process Research and Development | Valocor Therapeutics, Inc. [Member] | |
Acquired Indefinite Lived Intangible Assets [Line Items] | |
Impairment of intangible assets, indefinite-lived | $ 1,100 |
Convertible Notes - Additional
Convertible Notes - Additional Information (Details) - 3.00% Convertible Senior Notes due 2022 - USD ($) | 1 Months Ended | 3 Months Ended |
May 31, 2017 | Mar. 31, 2018 | |
Debt Instrument [Line Items] | ||
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. | |
Unamortized issuance costs and debt discounts | $ 7,700,000 | |
Private placement | ||
Debt Instrument [Line Items] | ||
Aggregate principal amount of notes | $ 287,500,000 | |
Debt instrument, interest rate | 3.00% | |
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 |
Collaboration and License Agr30
Collaboration and License Agreements - Maruho Agreement (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||
Oct. 31, 2016 | Sep. 30, 2016 | Mar. 31, 2013 | Mar. 31, 2018 | Jan. 01, 2018 | |
ASU 2014-09 | Adjustments due to Topic 606 | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Deferred revenue | $ (29,900,000) | ||||
Right of First Negotiation Agreement | Maruho Co. Ltd. | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Nonrefundable upfront payment received | $ 10,000,000 | ||||
Deferred revenue | $ 0 | ||||
Right of First Negotiation Agreement | Maruho Co. Ltd. | ASU 2014-09 | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Revenue, performance obligations | 0 | ||||
Right of First Negotiation Agreement | Maruho Co. Ltd. | ASU 2014-09 | Adjustments due to Topic 606 | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Deferred revenue | (10,000,000) | ||||
Maruho G.T. Agreement | Maruho Co. Ltd. | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Deferred revenue | $ 0 | ||||
Upfront payment received | $ 25,000,000 | ||||
Collaborative arrangement and license agreement expiration term, description | Unless earlier terminated, the Maruho G.T. Agreement will remain in effect until the later of: (1) expiration or abandonment of the last valid claim of the applicable patent rights in Japan; (2) expiration of any market exclusivity in Japan granted by the applicable regulatory authority; and (3) 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 | ||||
Maruho G.T. Agreement | Maruho Co. Ltd. | Maximum | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Addition payment to be received upon achievement of certain milestones | $ 70,000,000 | ||||
Maruho G.T. Agreement | Maruho Co. Ltd. | ASU 2014-09 | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Revenue, performance obligations | 25,000,000 | ||||
Maruho G.T. Agreement | Maruho Co. Ltd. | ASU 2014-09 | Adjustments due to Topic 606 | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Deferred revenue | $ (19,600,000) |
Collaboration and License Agr31
Collaboration and License Agreements - UCB Agreement (Details) - USD ($) | Jan. 01, 2018 | Nov. 06, 2017 | Mar. 31, 2014 | Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Refund liability | $ 10,000,000 | $ 10,000,000 | ||||
Collaboration and license revenue | $ 299,000 | $ 1,066,000 | ||||
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 | |||||
Additional payment to be received in consideration for repurchase of rights period | 30 days | |||||
Reimbursement of development costs incurred | $ 10,000,000 | |||||
Reimbursement of development costs description | We are 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. If the aggregate development costs reimbursed by us to UCB during this six-month period are less than $10.0 million, we will pay UCB the difference between such aggregate costs and $10.0 million. These terms replace the provisions of the UCB Agreement pursuant to which we would have been eligible to recoup our external development costs incurred related to the Cimzia program, net of milestones received, through a royalty on future net sales of Cimzia. | |||||
Threshold amount for payment of difference between counterparty development cost and threshold | 10,000,000 | |||||
Refund liability | $ 10,000,000 | |||||
Collaboration and license revenue | $ 300,000 | |||||
Deferred revenue | $ 80,000 | |||||
Development and Commercialization Agreement and Transition Agreement | UCB | ASU 2014-09 | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Payment to be received in consideration for repurchase of rights | $ 11,000,000 | |||||
Refund liability | 10,000,000 | |||||
Net consideration being recognized as revenue | $ 1,000,000 |
Collaboration and License Agr32
Collaboration and License Agreements - Roche Agreement (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Oct. 31, 2017 | Mar. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2018 | Sep. 30, 2018 | Aug. 31, 2017 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Accrued payments related to acquired in-process research and development, current | $ 51,802 | $ 50,161 | ||||
Roche Agreement | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Collaborative arrangement, agreement termination description | Unless earlier terminated, the Roche Agreement will remain in effect until no royalty or other payment obligations are or may become due. | |||||
Collaborative arrangement and license agreement expiration term, description | Royalty payments will be made from the first commercial sale date in a country (other than for the Retained Field) in such country and end on the later of the date that is (a) ten years after the date of the first commercial sale of lebrikizumab (other than for the Retained Field) in such country, (b) the expiration of the last to expire valid claim of the applicable licensed compound patent rights, Dermira patent rights or joint patent rights in such country covering the use, manufacturing, import, offering for sale, or sale of lebrikizumab (other than for the Retained Field) in such country, (c) 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 (d) the expiration of the last to expire regulatory exclusivity conferred by the applicable regulatory authority in such country for lebrikizumab (other than for the Retained Field). | |||||
Acquired IPR&D | $ 128,600 | |||||
License agreement initial payment | $ 80,000 | |||||
Accrued payments related to acquired in-process research and development, current | $ 51,800 | |||||
Roche Agreement | Development and Commercialization Agreement | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Initial payment made for licensing agreement | $ 80,000 | |||||
Roche Agreement | Initiation of First Phase 3 Clinical Study | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Payments to be made upon achievement of certain milestones | $ 40,000 | |||||
Roche Agreement | Achievement of Regulatory and First Commercial Sales Milestones | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Royalty payment period | 10 years | |||||
Roche Agreement | Achievement of Regulatory and First Commercial Sales Milestones | Maximum | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Payments to be made upon achievement of certain milestones | 210,000 | |||||
Roche Agreement | Scenario Forecast | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Additional payments to be made in licensing agreement | $ 30,000 | $ 25,000 | ||||
Roche Agreement | Scenario Forecast | Development and Commercialization Agreement | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Additional payments to be made in licensing agreement | $ 55,000 | |||||
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 | $ 1,000,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activitty 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 | 3 Months Ended |
Mar. 31, 2018$ / sharesshares | |
Shares Subject to Outstanding Stock Options | |
Stock options outstanding (in shares) | shares | 6,022 |
Stock options granted (in shares) | shares | 1,541 |
Stock options exercised (in shares) | shares | (44) |
Stock options forfeited (in shares) | shares | (132) |
Stock options outstanding (in shares) | shares | 7,387 |
Weighted-Average Exercise Price Per Share | |
Stock options outstanding (in dollars per share) | $ / shares | $ 19.15 |
Stock options granted (in dollars per share) | $ / shares | 27.33 |
Stock options exercised (in dollars per share) | $ / shares | 4.48 |
Stock options forfeited (in dollars per share) | $ / shares | 28.53 |
Stock options outstanding (in dollars per share | $ / shares | $ 20.78 |
Stock-Based Compensation - Su34
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 | 3 Months Ended |
Mar. 31, 2018$ / sharesshares | |
Shares Subject to Outstanding RSUs | |
RSUs outstanding at the beginning of the period (in shares) | shares | 296 |
RSUs granted (in shares) | shares | 301 |
RSUs vested and settled | shares | (6) |
RSUs forfeited (in shares) | shares | (16) |
RSUs outstanding at the end of the period (in shares) | shares | 575 |
Weighted-Average Grant Date Fair Value | |
RSUs outstanding at the beginning of the period (in dollars per share) | $ / shares | $ 30.81 |
RSUs granted (in dollars per share) | $ / shares | 27.60 |
RSUs vested and settled | $ / shares | 28.61 |
RSUs forfeited (in dollars per share) | $ / shares | 30.37 |
RSUs outstanding at the end of the period (in dollars per share) | $ / shares | $ 29.16 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Total Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | $ 7,514 | $ 4,615 |
Research and development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | 2,853 | 1,796 |
General and administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total stock-based compensation expense | $ 4,661 | $ 2,819 |