Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Aug. 04, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | ALDR | |
Entity Registrant Name | ALDER BIOPHARMACEUTICALS INC | |
Entity Central Index Key | 1,423,824 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 67,713,633 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Current assets | ||
Cash and cash equivalents | $ 127,789 | $ 116,216 |
Short-term investments | 96,692 | 235,651 |
Prepaid expenses and other assets | 21,221 | 40,380 |
Inventory | 936 | 936 |
Total current assets | 246,638 | 393,183 |
Property and equipment, net | 6,714 | 7,076 |
Investment in unconsolidated entity | 586 | 865 |
Other assets | 30 | 8,030 |
Total assets | 253,968 | 409,154 |
Current liabilities | ||
Accounts payable | 19,796 | 10,361 |
Accrued liabilities | 14,236 | 15,437 |
Deferred rent | 92 | 92 |
Total current liabilities | 34,124 | 25,890 |
Long-term deferred rent | 423 | 481 |
Total liabilities | 34,547 | 26,371 |
Commitments and contingencies | ||
Stockholders’ equity | ||
Common stock; $0.0001 par value; 200,000,000 shares authorized; 50,461,985 and 50,368,206 shares issued and outstanding, respectively | 5 | 5 |
Additional paid-in capital | 773,071 | 761,456 |
Accumulated deficit | (553,587) | (378,630) |
Accumulated other comprehensive loss | (68) | (48) |
Total stockholders’ equity | 219,421 | 382,783 |
Total liabilities and stockholders’ equity | $ 253,968 | $ 409,154 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2017 | Dec. 31, 2016 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 50,461,985 | 50,368,206 |
Common stock, shares outstanding | 50,461,985 | 50,368,206 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Revenues | ||||
Collaboration and license agreements | $ 683 | $ 113 | $ 683 | $ 113 |
Operating expenses | ||||
Cost of sales | 683 | 113 | 683 | 113 |
Research and development | 65,276 | 33,833 | 155,965 | 61,480 |
General and administrative | 9,548 | 6,466 | 19,529 | 12,511 |
Total operating expenses | 75,507 | 40,412 | 176,177 | 74,104 |
Gain on license of clazakizumab | 1,050 | 1,050 | ||
Loss from operations | (74,824) | (39,249) | (175,494) | (72,941) |
Other income (expense) | ||||
Interest income | 438 | 529 | 923 | 944 |
Foreign currency loss | (113) | (146) | (107) | (232) |
Total other income, net | 325 | 383 | 816 | 712 |
Net loss before equity in net loss of unconsolidated entity | (74,499) | (38,866) | (174,678) | (72,229) |
Equity in net loss of unconsolidated entity | (130) | (279) | ||
Net loss | $ (74,629) | $ (38,866) | $ (174,957) | $ (72,229) |
Net loss per share - basic and diluted | $ (1.48) | $ (0.79) | $ (3.47) | $ (1.55) |
Weighted average number of common shares used in net loss per share - basic and diluted | 50,427,865 | 49,284,573 | 50,411,837 | 46,519,045 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (74,629) | $ (38,866) | $ (174,957) | $ (72,229) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on securities available-for-sale, net of tax | (73) | 146 | (20) | 560 |
Foreign currency translation income, net of tax | 21 | |||
Total other comprehensive income (loss) | (73) | 146 | (20) | 581 |
Comprehensive loss | $ (74,702) | $ (38,720) | $ (174,977) | $ (71,648) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Operating activities | ||
Net loss | $ (174,957) | $ (72,229) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Non-cash gain on license of clazakizumab in exchange for investment in unconsolidated entity | (1,050) | |
Equity in net loss of unconsolidated entity | 279 | |
Depreciation and amortization | 1,486 | 505 |
Stock-based compensation | 10,901 | 6,348 |
Other non-cash charges, net | 300 | 65 |
Changes in operating assets and liabilities | ||
Prepaid expenses and other assets | 27,159 | 291 |
Inventory | (936) | |
Accounts payable | 9,837 | 2,851 |
Accrued liabilities | (1,201) | 111 |
Deferred rent | (58) | 28 |
Net cash used in operating activities | (126,254) | (64,016) |
Investing activities | ||
Purchases of investments | (28,334) | (55,613) |
Proceeds from maturities of investments | 166,973 | 10,250 |
Purchases of property and equipment | (1,526) | (2,953) |
Proceeds from sale of property and equipment | 5 | |
Net cash provided by (used in) investing activities | 137,113 | (48,311) |
Financing activities | ||
Proceeds from issuance of common stock, net of offering costs | 134,871 | |
Proceeds from exercise of stock options and employee stock purchase plan | 714 | 979 |
Net cash provided by financing activities | 714 | 135,850 |
Effect of exchange rate changes on cash | 21 | |
Net increase in cash and cash equivalents | 11,573 | 23,544 |
Cash and cash equivalents | ||
Beginning of period | 116,216 | 206,492 |
End of period | 127,789 | 230,036 |
Supplemental disclosures: | ||
Purchases of property and equipment included in accounts payable and accrued liabilities | $ 101 | $ 1,156 |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 30, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Business | 1. Nature of Business Alder BioPharmaceuticals, Inc. (the “Company”) is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. The Company has developed a proprietary antibody platform designed to select and manufacture antibodies that have the potential to maximize efficacy as well as speed of onset and durability of therapeutic response. The Company was incorporated in Delaware on May 20, 2002 and is located in Bothell, Washington. Public Offerings In April 2016, the Company completed an underwritten public offering of 6,182,795 shares of common stock, which included 806,451 shares the Company issued pursuant to the underwriters’ exercise of their option to purchase additional shares. The Company received $134.9 million in net proceeds, after deducting underwriting discounts and commissions of $8.6 million and offering expenses of $0.3 million. On July 18, 2017, the Company completed an underwritten public offering of 17,250,000 shares of common stock, which included 2,250,000 shares the Company issued pursuant to the underwriters’ exercise of their option to purchase additional shares. The Company received approximately $161.5 million in net proceeds, after deducting underwriting discounts and commissions of $10.4 million and estimated offering expenses of $0.7 million. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying unaudited condensed consolidated financial statements reflect the accounts of Alder BioPharmaceuticals, Inc. and its wholly-owned subsidiaries. All inter-company balances and transactions have been eliminated in consolidation. The condensed consolidated balance sheet data as of December 31, 2016 were derived from audited financial statements. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) and generally accepted accounting principles in the United States of America (“GAAP”) for unaudited condensed consolidated financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements reflect all adjustments consisting of normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. The Company manages its business as one operating segment; however, the Company operates in three The Company has a relationship with a variable interest entity (“VIE”). The Company evaluates VIEs to determine whether the Company is the primary beneficiary by performing a qualitative and quantitative analysis of each VIE that includes a review of, among other factors, the VIE’s capital structure, contractual terms, related party relationships, the Company’s fee arrangements and the design of the VIE. This analysis includes determining whether the Company (1) has the power to direct matters that most significantly impact the activities of the VIE, and (2) has the obligation to absorb losses or the right to receive benefits of the VIE that could potentially be significant to the VIE. In circumstances where the Company is not the primary beneficiary, but the Company has the ability to exercise significant influence over the operating and financial policies of a company in which it has an investment, the Company utilizes the equity method of accounting for recording investment activity. In assessing whether the Company exercises significant influence, it considers the nature and magnitude of the investment, the voting and protective rights held, any participation in the governance of the other company, and other relevant factors such as the presence of a collaboration or other business relationship. Under the equity method of accounting, the Company records in its results of operations its share of income or loss of the other company. If the Company’s share of losses exceeds the carrying value of its investment, it will suspend recognizing additional losses and will continue to do so unless the Company commits to providing additional funding. The Company monitors its investment to evaluate whether any decline in value has occurred that would be other-than-temporary, based on the implied value of recent company financings, public market prices of comparable companies, and general market conditions. The carrying value of the investment is included in the Company’s condensed consolidated balance sheet as investment in unconsolidated entity. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The results of the Company’s operations for the three and six months ended June 30, 2017 are not necessarily indicative of the results to be expected for the full year or for any other period. Concentrations of Credit Risk The Company is exposed to credit risk from its deposits of cash, cash equivalents and short-term investments in excess of amounts insured by the Federal Deposit Insurance Corporation. Other Non-Current Assets As of December 31, 2016, other non-current assets included an $8.0 million fee paid to a third party to secure additional production capacity. Upon execution of a binding agreement in March 2017, this payment was characterized as a non-refundable payment and recognized as research and development expense during the first quarter ended March 31, 2017. Liquidity and Going Concern As disclosed in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2017 (the “Q1 2017 Form 10-Q”), in accordance with the requirements of ASC 205-40, management concluded that it was required to disclose that substantial doubt existed about the Company’s ability to continue as a going concern for one year from the date the financial statements included in the Q1 2017 Form 10-Q were issued. On July 18, 2017, the Company received approximately $161.5 million in net proceeds from an underwritten public offering of common stock. The Company also decreased its forecasted cash requirements for operating activities over the next year. The Company estimates the available cash, cash equivalents and investments as of June 30, 2017, together with the proceeds received from the July 2017 offering, will be sufficient to meet its projected operating requirements for at least the next twelve months from the filing date of these financial statements. As a result of these conditions and events, substantial doubt of the Company’s ability to continue as a going concern no longer exists. The Company will need to obtain substantial additional funding to develop and commercialize eptinezumab and other clinical programs as currently contemplated. The Company expects to finance future cash needs through equity financings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements, but there are no assurances that the Company will be able to raise sufficient amounts of funding in the future on acceptable terms, or at all. The condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. This ASU stipulates that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In March 2016, the FASB issued ASU 2016-08, Principal versus Agent Considerations (Reporting Revenue Gross versus Net). This ASU clarifies the implementation guidance on principal versus agent considerations. In April 2016, the FASB issued ASU 2016-10, Identifying Performance Obligations and Licensing. This ASU clarifies two aspects of ASU 2014-09, Revenue from Contracts with Customers (Topic 606): Identifying performance obligations and the licensing implementation guidance. In May 2016, the FASB issued ASU 2016-12, Narrow-Scope Improvements and Practical Expedients. This ASU addresses certain issues in ASU 2014-09, Revenue from Contracts with Customers (Topic 606) regarding assessing collectability, presentation of sales taxes, noncash consideration, and completed contracts and contract modifications at transition. In December 2016, the FASB issued ASU 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. This ASU amends narrow aspects of ASU 2014-09, Revenue from Contracts with Customers. The new revenue standards are effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Early adoption is permitted for annual reporting periods beginning after the original effective date of December 15, 2016. The standards permit the use of either the full retrospective or modified retrospective method. The Company does not believe adopting this guidance will have a material impact on its financial statements as the Company is not currently generating material revenues. In January 2016, the FASB issued ASU 2016-01, Financial Instruments-Overall. This ASU addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. This ASU will become effective for annual periods beginning after December 15, 2017. The Company is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements. In February 2016, the FASB issued ASU 2016-02, Leases. This ASU requires the recognition of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements. This ASU will become effective for annual periods beginning after December 15, 2018. The Company expects adopting this ASU will result in an increase in the assets and liabilities on its consolidated balance sheets and will have no impact on its consolidated statements of operations and statement of cash flows. In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows – Classification of Certain Cash Receipts and Cash Payments. This ASU addresses eight specific cash flow issues with the objective of reducing the existing diversity in practice. This ASU will become effective for annual periods beginning after December 15, 2017. The Company does not believe adopting this ASU will have a material impact as it relates to the treatment of equity distributions which are currently not material to the Company. In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) – Scope of Modification Accounting. This ASU provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. This ASU will become effective for annual periods beginning after December 15, 2017. The Company is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements. The Company has reviewed other recent accounting pronouncements and concluded that they are either not applicable to the business, or that no material effect is expected on the consolidated financial statements as a result of future adoption. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2017 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 3. Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted average common shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted average common shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. Three Months Ended Six Months Ended June 30, June 30, 2017 2016 2017 2016 Net loss (in thousands) $ (74,629 ) $ (38,866 ) $ (174,957 ) $ (72,229 ) Denominator Weighted average common shares outstanding - basic and diluted 50,427,865 49,284,573 50,411,837 46,519,045 Net loss per share - basic and diluted $ (1.48 ) $ (0.79 ) $ (3.47 ) $ (1.55 ) The following weighted average numbers of outstanding stock options and employee stock purchase plan awards were excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2017 and 2016 because including them would have had an anti-dilutive effect. Therefore, basic and diluted net loss per share were the same for all periods presented. Three Months Ended Six Months Ended June 30, June 30, 2017 2016 2017 2016 Stock options 6,795,748 4,270,080 6,381,733 4,009,156 Employee stock purchase plan 61,354 22,814 116,887 43,511 6,857,102 4,292,894 6,498,620 4,052,667 |
Short-term Investments
Short-term Investments | 6 Months Ended |
Jun. 30, 2017 | |
Short Term Investments [Abstract] | |
Short-term Investments | 4. Short-term Investments Short-term investments consisted of available-for-sale securities as follows: Amortized Cost Gross unrealized gains Gross unrealized losses Fair Value (in thousands) Type of security as of June 30, 2017 Negotiable certificates of deposit maturing in one year or less $ 5,000 $ — $ (1 ) $ 4,999 U.S. government agency obligations maturing in one year or less 91,758 — (65 ) 91,693 Total available-for-sale securities $ 96,758 $ — $ (66 ) $ 96,692 Type of security as of December 31, 2016 Negotiable certificates of deposit maturing in one year or less $ 11,000 $ 1 $ (4 ) $ 10,997 U.S. government agency obligations maturing in one year or less 224,697 27 (70 ) 224,654 Total available-for-sale securities $ 235,697 $ 28 $ (74 ) $ 235,651 Realized gains and losses are determined based on the specific identification method and are reported in other income in the condensed consolidated statement of operations. There were no realized gains or losses on sales of available-for-sale securities in the three and six months ended June 30, 2017 and 2016. |
Fair Value Disclosures
Fair Value Disclosures | 6 Months Ended |
Jun. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosures | 5 . Fair Value Disclosures The Company holds financial instruments that are measured at fair value which is determined according to a fair value hierarchy that prioritizes the inputs and assumptions used, and the valuation techniques used to measure fair value. The three levels of the fair value hierarchy are described as follows: Level 1 Inputs are unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 Inputs are quoted prices for similar assets and liabilities in active markets or quoted prices for identical or similar instruments in markets that are not active and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets. Level 3 Inputs are unobservable inputs based on the Company’s own assumptions and valuation techniques used to measure assets and liabilities at fair value. The inputs require significant management judgment or estimation. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of fair value assets and liabilities and their placement within the fair value hierarchy levels. The Company established the fair value of its assets and liabilities using the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date and established a fair value hierarchy based on the inputs used to measure fair value. The following table presents the Company’s financial instruments by level within the fair value hierarchy: Fair Value Measurement Using Level 1 Level 2 Level 3 Total (in thousands) As of June 30, 2017 Cash equivalents Money market funds $ 95,063 $ — $ — $ 95,063 Short-term investments Negotiable certificates of deposit — 4,999 — 4,999 U.S. government agency obligations — 91,693 — 91,693 $ 95,063 $ 96,692 $ — $ 191,755 As of December 31, 2016 Cash equivalents Money market funds $ 111,149 $ — $ — $ 111,149 Short-term investments Negotiable certificates of deposit — 10,997 — 10,997 U.S. government agency obligations — 224,654 — 224,654 $ 111,149 $ 235,651 $ — $ 346,800 The Company’s negotiable certificates of deposit and U.S. government agency obligations are valued using fair value measurements that are considered to be Level 2. The investment custodian provides the Company with valuations of its securities portfolio. The primary source for the security valuation is Interactive Data Corporation (“IDC”), which evaluates securities based on market data. IDC utilizes evaluated pricing models that vary by asset class and include available trade, bid, and other market information. Generally, the methodology includes broker quotes, proprietary models, vast descriptive terms and conditions databases, as well as extensive quality control programs. The custodian utilizes proprietary valuation matrices for valuing all negotiable certificates of deposit. Accounts payable and accrued liabilities are carried at cost, which approximates fair value due to the short-term nature of these financial instruments. |
Gain on License of Clazakizumab
Gain on License of Clazakizumab and Investment in Unconsolidated Entity | 6 Months Ended |
Jun. 30, 2017 | |
Gain On License Agreements And Investment In Unconsolidated Entity [Abstract] | |
Gain on License of Clazakizumab and Investment in Unconsolidated Entity | 6. Gain on License of Clazakizumab and Investment in Unconsolidated Entity In May 2016, the Company licensed the exclusive worldwide rights to its product candidate clazakizumab to Vitaeris, Inc. (“Vitaeris”), based in Vancouver, British Columbia, that is pursuing innovative therapeutic indications in chronic inflammatory diseases. In exchange for the rights to clazakizumab, the Company received an equity stake in Vitaeris and is eligible to receive royalties and certain other payments. In addition, Randall C. Schatzman, Ph.D., the Company’s president and chief executive officer, joined Vitaeris’ board of directors. As of June 30, 2017, the Company held $0.9 million in inventory of finished goods related to clazakizumab on its condensed consolidated balance sheet. Clazakizumab has not received regulatory approval for commercial sale and the related inventory is currently held only for resale associated with the Vitaeris agreement. The Company values inventory at the lower of cost or market value which is determined using the specific identification basis. Inventory is reduced to net realizable value for excess, obsolete or unsalable inventory. Vitaeris is a VIE for which the Company is not the primary beneficiary as the Company does not have the power to direct the activities that most significantly influence the economic performance of the entity. In addition to the Company’s exchange of license rights for clazakizumab, Vitaeris was capitalized through cash investments by other parties. The investment in Vitaeris is accounted for under the equity method of accounting because the Company holds common stock of Vitaeris and has significant influence over the operating and financial policies of Vitaeris through its ownership, license arrangement and representation on the board of directors. Therefore, the Company records its share of any loss or income generated by Vitaeris, which is recorded on a three-month lag, within the condensed consolidated statement of operations. The investment is reflected as an investment in unconsolidated entity on the Company’s condensed consolidated balance sheet which represents the investment in Vitaeris, net of the Company’s portion of any generated loss or income. The Company recorded $0.1 million and $0.3 million in net loss with respect to Vitaeris for the three and six months ended June 30, 2017, respectively. The carrying value of the Company’s investment in Vitaeris is $0.6 million as of June 30, 2017, which is classified as a non-current asset. The Company has no implied or unfunded commitments related to Vitaeris and its maximum exposure to loss is limited to the current carrying value of the investment. |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2017 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | 7. Accrued Liabilities Accrued liabilities consisted of the following for the dates indicated: June 30, December 31, 2017 2016 (in thousands) Compensation and benefits $ 4,244 $ 4,833 Contracted research and development 8,574 9,837 Professional services and other 1,418 767 $ 14,236 $ 15,437 |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Event | 8. Subsequent Event On July 18, 2017, the Company completed an underwritten public offering of 17,250,000 shares of common stock, which included 2,250,000 shares the Company issued pursuant to the underwriters’ exercise of their option to purchase additional shares. The Company received approximately $161.5 million in net proceeds, after deducting underwriting discounts and commissions of $10.4 million and estimated offering expenses of $0.7 million. |
Summary of Significant Accoun15
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying unaudited condensed consolidated financial statements reflect the accounts of Alder BioPharmaceuticals, Inc. and its wholly-owned subsidiaries. All inter-company balances and transactions have been eliminated in consolidation. The condensed consolidated balance sheet data as of December 31, 2016 were derived from audited financial statements. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) and generally accepted accounting principles in the United States of America (“GAAP”) for unaudited condensed consolidated financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements reflect all adjustments consisting of normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. The Company manages its business as one operating segment; however, the Company operates in three The Company has a relationship with a variable interest entity (“VIE”). The Company evaluates VIEs to determine whether the Company is the primary beneficiary by performing a qualitative and quantitative analysis of each VIE that includes a review of, among other factors, the VIE’s capital structure, contractual terms, related party relationships, the Company’s fee arrangements and the design of the VIE. This analysis includes determining whether the Company (1) has the power to direct matters that most significantly impact the activities of the VIE, and (2) has the obligation to absorb losses or the right to receive benefits of the VIE that could potentially be significant to the VIE. In circumstances where the Company is not the primary beneficiary, but the Company has the ability to exercise significant influence over the operating and financial policies of a company in which it has an investment, the Company utilizes the equity method of accounting for recording investment activity. In assessing whether the Company exercises significant influence, it considers the nature and magnitude of the investment, the voting and protective rights held, any participation in the governance of the other company, and other relevant factors such as the presence of a collaboration or other business relationship. Under the equity method of accounting, the Company records in its results of operations its share of income or loss of the other company. If the Company’s share of losses exceeds the carrying value of its investment, it will suspend recognizing additional losses and will continue to do so unless the Company commits to providing additional funding. The Company monitors its investment to evaluate whether any decline in value has occurred that would be other-than-temporary, based on the implied value of recent company financings, public market prices of comparable companies, and general market conditions. The carrying value of the investment is included in the Company’s condensed consolidated balance sheet as investment in unconsolidated entity. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The results of the Company’s operations for the three and six months ended June 30, 2017 are not necessarily indicative of the results to be expected for the full year or for any other period. |
Concentrations of Credit Risk | Concentrations of Credit Risk The Company is exposed to credit risk from its deposits of cash, cash equivalents and short-term investments in excess of amounts insured by the Federal Deposit Insurance Corporation. |
Other Non-Current Assets | Other Non-Current Assets As of December 31, 2016, other non-current assets included an $8.0 million fee paid to a third party to secure additional production capacity. Upon execution of a binding agreement in March 2017, this payment was characterized as a non-refundable payment and recognized as research and development expense during the first quarter ended March 31, 2017. |
Liquidity and Going Concern | Liquidity and Going Concern As disclosed in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2017 (the “Q1 2017 Form 10-Q”), in accordance with the requirements of ASC 205-40, management concluded that it was required to disclose that substantial doubt existed about the Company’s ability to continue as a going concern for one year from the date the financial statements included in the Q1 2017 Form 10-Q were issued. On July 18, 2017, the Company received approximately $161.5 million in net proceeds from an underwritten public offering of common stock. The Company also decreased its forecasted cash requirements for operating activities over the next year. The Company estimates the available cash, cash equivalents and investments as of June 30, 2017, together with the proceeds received from the July 2017 offering, will be sufficient to meet its projected operating requirements for at least the next twelve months from the filing date of these financial statements. As a result of these conditions and events, substantial doubt of the Company’s ability to continue as a going concern no longer exists. The Company will need to obtain substantial additional funding to develop and commercialize eptinezumab and other clinical programs as currently contemplated. The Company expects to finance future cash needs through equity financings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements, but there are no assurances that the Company will be able to raise sufficient amounts of funding in the future on acceptable terms, or at all. The condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. This ASU stipulates that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In March 2016, the FASB issued ASU 2016-08, Principal versus Agent Considerations (Reporting Revenue Gross versus Net). This ASU clarifies the implementation guidance on principal versus agent considerations. In April 2016, the FASB issued ASU 2016-10, Identifying Performance Obligations and Licensing. This ASU clarifies two aspects of ASU 2014-09, Revenue from Contracts with Customers (Topic 606): Identifying performance obligations and the licensing implementation guidance. In May 2016, the FASB issued ASU 2016-12, Narrow-Scope Improvements and Practical Expedients. This ASU addresses certain issues in ASU 2014-09, Revenue from Contracts with Customers (Topic 606) regarding assessing collectability, presentation of sales taxes, noncash consideration, and completed contracts and contract modifications at transition. In December 2016, the FASB issued ASU 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers. This ASU amends narrow aspects of ASU 2014-09, Revenue from Contracts with Customers. The new revenue standards are effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Early adoption is permitted for annual reporting periods beginning after the original effective date of December 15, 2016. The standards permit the use of either the full retrospective or modified retrospective method. The Company does not believe adopting this guidance will have a material impact on its financial statements as the Company is not currently generating material revenues. In January 2016, the FASB issued ASU 2016-01, Financial Instruments-Overall. This ASU addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. This ASU will become effective for annual periods beginning after December 15, 2017. The Company is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements. In February 2016, the FASB issued ASU 2016-02, Leases. This ASU requires the recognition of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements. This ASU will become effective for annual periods beginning after December 15, 2018. The Company expects adopting this ASU will result in an increase in the assets and liabilities on its consolidated balance sheets and will have no impact on its consolidated statements of operations and statement of cash flows. In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows – Classification of Certain Cash Receipts and Cash Payments. This ASU addresses eight specific cash flow issues with the objective of reducing the existing diversity in practice. This ASU will become effective for annual periods beginning after December 15, 2017. The Company does not believe adopting this ASU will have a material impact as it relates to the treatment of equity distributions which are currently not material to the Company. In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) – Scope of Modification Accounting. This ASU provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. This ASU will become effective for annual periods beginning after December 15, 2017. The Company is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements. The Company has reviewed other recent accounting pronouncements and concluded that they are either not applicable to the business, or that no material effect is expected on the consolidated financial statements as a result of future adoption. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Earnings per Share | Basic net loss per share is calculated by dividing net loss by the weighted average common shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted average common shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. Three Months Ended Six Months Ended June 30, June 30, 2017 2016 2017 2016 Net loss (in thousands) $ (74,629 ) $ (38,866 ) $ (174,957 ) $ (72,229 ) Denominator Weighted average common shares outstanding - basic and diluted 50,427,865 49,284,573 50,411,837 46,519,045 Net loss per share - basic and diluted $ (1.48 ) $ (0.79 ) $ (3.47 ) $ (1.55 ) |
Schedule of Weighted Average Numbers of Outstanding Stock Options and Employee Stock Purchase Plan Awards Excluded from Calculation of Diluted Net Loss Per Share | The following weighted average numbers of outstanding stock options and employee stock purchase plan awards were excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2017 and 2016 because including them would have had an anti-dilutive effect. Therefore, basic and diluted net loss per share were the same for all periods presented. Three Months Ended Six Months Ended June 30, June 30, 2017 2016 2017 2016 Stock options 6,795,748 4,270,080 6,381,733 4,009,156 Employee stock purchase plan 61,354 22,814 116,887 43,511 6,857,102 4,292,894 6,498,620 4,052,667 |
Short-term Investments (Tables)
Short-term Investments (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Short Term Investments [Abstract] | |
Schedule of Available for Sale Securities | Short-term investments consisted of available-for-sale securities as follows: Amortized Cost Gross unrealized gains Gross unrealized losses Fair Value (in thousands) Type of security as of June 30, 2017 Negotiable certificates of deposit maturing in one year or less $ 5,000 $ — $ (1 ) $ 4,999 U.S. government agency obligations maturing in one year or less 91,758 — (65 ) 91,693 Total available-for-sale securities $ 96,758 $ — $ (66 ) $ 96,692 Type of security as of December 31, 2016 Negotiable certificates of deposit maturing in one year or less $ 11,000 $ 1 $ (4 ) $ 10,997 U.S. government agency obligations maturing in one year or less 224,697 27 (70 ) 224,654 Total available-for-sale securities $ 235,697 $ 28 $ (74 ) $ 235,651 |
Fair Value Disclosures (Tables)
Fair Value Disclosures (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Instruments by Level within Fair Value Hierarchy | The following table presents the Company’s financial instruments by level within the fair value hierarchy: Fair Value Measurement Using Level 1 Level 2 Level 3 Total (in thousands) As of June 30, 2017 Cash equivalents Money market funds $ 95,063 $ — $ — $ 95,063 Short-term investments Negotiable certificates of deposit — 4,999 — 4,999 U.S. government agency obligations — 91,693 — 91,693 $ 95,063 $ 96,692 $ — $ 191,755 As of December 31, 2016 Cash equivalents Money market funds $ 111,149 $ — $ — $ 111,149 Short-term investments Negotiable certificates of deposit — 10,997 — 10,997 U.S. government agency obligations — 224,654 — 224,654 $ 111,149 $ 235,651 $ — $ 346,800 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following for the dates indicated: June 30, December 31, 2017 2016 (in thousands) Compensation and benefits $ 4,244 $ 4,833 Contracted research and development 8,574 9,837 Professional services and other 1,418 767 $ 14,236 $ 15,437 |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) - USD ($) $ in Millions | Jul. 18, 2017 | Apr. 30, 2016 | Jun. 30, 2017 |
Nature Of Operations [Line Items] | |||
Company Incorporation, date | May 20, 2002 | ||
Public offering, shares issued | 6,182,795 | ||
Proceeds from the public offering | $ 134.9 | ||
Underwriting discounts and commissions | 8.6 | ||
Offering expenses | $ 0.3 | ||
Subsequent Event | |||
Nature Of Operations [Line Items] | |||
Public offering, shares issued | 17,250,000 | ||
Proceeds from the public offering | $ 161.5 | ||
Underwriting discounts and commissions | 10.4 | ||
Offering expenses | $ 0.7 | ||
Over Allotment Option | |||
Nature Of Operations [Line Items] | |||
Public offering, shares issued | 806,451 | ||
Over Allotment Option | Subsequent Event | |||
Nature Of Operations [Line Items] | |||
Public offering, shares issued | 2,250,000 |
Summary of Significant Accoun21
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Millions | Jul. 18, 2017USD ($) | Apr. 30, 2016USD ($) | Jun. 30, 2017SegmentCountry | Dec. 31, 2016USD ($) |
Significant Accounting Policies [Line Items] | ||||
Number of operating segment | Segment | 1 | |||
Number of operating geographic regions | Country | 3 | |||
Proceeds from the public offering | $ 134.9 | |||
Subsequent Event | ||||
Significant Accounting Policies [Line Items] | ||||
Proceeds from the public offering | $ 161.5 | |||
Other non-current assets | ||||
Significant Accounting Policies [Line Items] | ||||
Non refundable fee | $ 8 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Basic and Diluted Earnings per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (74,629) | $ (38,866) | $ (174,957) | $ (72,229) |
Denominator | ||||
Weighted average common shares outstanding - basic and diluted | 50,427,865 | 49,284,573 | 50,411,837 | 46,519,045 |
Net loss per share - basic and diluted | $ (1.48) | $ (0.79) | $ (3.47) | $ (1.55) |
Net Loss Per Share - Schedule23
Net Loss Per Share - Schedule of Weighted Average Numbers of Outstanding Stock Options and Employee Purchase Plan Awards Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Outstanding stock options and employee stock purchase plan awards excluded from calculation of diluted net loss per share | 6,857,102 | 4,292,894 | 6,498,620 | 4,052,667 |
Stock options | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Outstanding stock options and employee stock purchase plan awards excluded from calculation of diluted net loss per share | 6,795,748 | 4,270,080 | 6,381,733 | 4,009,156 |
Employee stock purchase plan | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Outstanding stock options and employee stock purchase plan awards excluded from calculation of diluted net loss per share | 61,354 | 22,814 | 116,887 | 43,511 |
Short-term Investments - Schedu
Short-term Investments - Schedule of Available for Sale Securities (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 96,758 | $ 235,697 |
Gross unrealized gains | 28 | |
Gross unrealized losses | (66) | (74) |
Fair Value | 96,692 | 235,651 |
Negotiable certificates of deposit maturing in one year or less | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 5,000 | 11,000 |
Gross unrealized gains | 1 | |
Gross unrealized losses | (1) | (4) |
Fair Value | 4,999 | 10,997 |
U.S. government agency obligations maturing in one year or less | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 91,758 | 224,697 |
Gross unrealized gains | 27 | |
Gross unrealized losses | (65) | (70) |
Fair Value | $ 91,693 | $ 224,654 |
Short-term Investments - Additi
Short-term Investments - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Investments Debt And Equity Securities [Abstract] | ||||
Available for sale securities realized gains or losses | $ 0 | $ 0 | $ 0 | $ 0 |
Fair Value Disclosures - Schedu
Fair Value Disclosures - Schedule of Financial Instruments by Level within Fair Value Hierarchy (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 96,692 | $ 235,651 |
Assets at fair value | 191,755 | 346,800 |
Money market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 95,063 | 111,149 |
Negotiable Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | 4,999 | 10,997 |
U.S. government agency obligations | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | 91,693 | 224,654 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets at fair value | 95,063 | 111,149 |
Level 1 | Money market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 95,063 | 111,149 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets at fair value | 96,692 | 235,651 |
Level 2 | Negotiable Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | 4,999 | 10,997 |
Level 2 | U.S. government agency obligations | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 91,693 | $ 224,654 |
Gain on License of Clazakizum27
Gain on License of Clazakizumab and Investment in Unconsolidated Entity - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | |
Gain on License Agreements and Investment in Unconsolidated Entity [Line Items] | |||||
Initial gain on license agreement | $ 1,050 | $ 1,050 | |||
Net loss recorded | $ 130 | $ 279 | |||
Carrying value of investment | 586 | 586 | $ 865 | ||
Vitaeris, Inc. | |||||
Gain on License Agreements and Investment in Unconsolidated Entity [Line Items] | |||||
Initial gain on license agreement | 1,100 | ||||
Inventory of finished goods | 900 | $ 900 | |||
Lag in recording company's share of loss or income generated by unconsolidated entity within condensed consolidated statement of operations (in months) | 3 months | ||||
Net loss recorded | 100 | $ 300 | |||
Carrying value of investment | $ 600 | $ 600 |
Accrued Liabilities - Schedule
Accrued Liabilities - Schedule of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Payables And Accruals [Abstract] | ||
Compensation and benefits | $ 4,244 | $ 4,833 |
Contracted research and development | 8,574 | 9,837 |
Professional services and other | 1,418 | 767 |
Accrued liabilities | $ 14,236 | $ 15,437 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - USD ($) $ in Millions | Jul. 18, 2017 | Apr. 30, 2016 |
Subsequent Event [Line Items] | ||
Public offering, shares issued | 6,182,795 | |
Proceeds from the public offering | $ 134.9 | |
Underwriting discounts and commissions | 8.6 | |
Offering expenses | $ 0.3 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Public offering, shares issued | 17,250,000 | |
Proceeds from the public offering | $ 161.5 | |
Underwriting discounts and commissions | 10.4 | |
Offering expenses | $ 0.7 | |
Over Allotment Option | ||
Subsequent Event [Line Items] | ||
Public offering, shares issued | 806,451 | |
Over Allotment Option | Subsequent Event | ||
Subsequent Event [Line Items] | ||
Public offering, shares issued | 2,250,000 |