Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Nov. 06, 2014 | |
Entity Information [Line Items] | ' | ' |
Entity Registrant Name | 'NEWLINK GENETICS CORP | ' |
Entity Central Index Key | '0001126234 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Document Type | '10-Q | ' |
Document Period End Date | 30-Sep-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Amendment Flag | 'false | ' |
Entity Common Stock, Shares Outstanding | ' | 27,959,553 |
Entity Well-known Seasoned Issuer | 'No | ' |
Entity Voluntary Filers | 'No | ' |
Entity Current Reporting Status | 'Yes | ' |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $51,070 | $61,291 |
Certificates of deposit | 16,636 | 249 |
Prepaid expenses | 353 | 773 |
Income tax receivable | 7,502 | 0 |
State research and development credit receivable | 479 | 329 |
Other receivables | 2,720 | 1,328 |
Total current assets | 78,760 | 63,970 |
Leasehold improvements and equipment: | ' | ' |
Leasehold improvements | 5,581 | 5,588 |
Computer equipment | 1,311 | 1,133 |
Lab equipment | 4,897 | 3,724 |
Total leasehold improvements and equipment | 11,789 | 10,445 |
Less accumulated depreciation and amortization | -4,672 | -3,858 |
Leasehold improvements and equipment, net | 7,117 | 6,587 |
Total assets | 85,877 | 70,557 |
Current liabilities: | ' | ' |
Accounts payable | 2,935 | 612 |
Accrued expenses | 4,026 | 2,861 |
Income taxes payable | 0 | 130 |
Current portion of deferred rent | 84 | 84 |
Current portion of long term debt and obligations under capital leases | 193 | 189 |
Total current liabilities | 7,238 | 3,876 |
Long-term liabilities: | ' | ' |
Royalty obligation payable to Iowa Economic Development Authority | 6,000 | 6,000 |
Notes payable and obligations under capital leases | 989 | 1,033 |
Deferred rent, excluding current portion | 1,259 | 1,321 |
Total long-term liabilities | 8,248 | 8,354 |
Total liabilities | 15,486 | 12,230 |
Stockholders' Equity: | ' | ' |
Blank check preferred stock, $0.01 par value: Authorized shares — 5,000,000 at September 30, 2014 and December 31, 2013; issued and outstanding shares — 0 at September 30, 2014 and December 31, 2013 | 0 | 0 |
Common stock, $0.01 par value: Authorized shares — 75,000,000 at September 30, 2014 and December 31, 2013; issued shares — 27,940,267 and outstanding shares — 27,929,874 at September 30, 2014, and issued and outstanding shares — 26,573,023 at December 31, 2013 | 279 | 266 |
Additional paid-in capital | 230,308 | 194,038 |
Treasury stock, at cost: 10,393 shares at September 30, 2014 | -222 | 0 |
Retained deficit | -159,974 | -135,977 |
Total stockholders' equity | 70,391 | 58,327 |
Total liabilities and stockholders' equity | $85,877 | $70,557 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parentheticals) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Stockholders' Equity: | ' | ' |
Blank check preferred stock, par value | $0.01 | $0.01 |
Blank check preferred stock, authorized shares | 5,000,000 | 5,000,000 |
Blank check preferred stock, issued shares | 0 | 0 |
Blank check preferred stock, outstanding shares | 0 | 0 |
Common stock, par value | $0.01 | $0.01 |
Common stock, authorized shares | 75,000,000 | 75,000,000 |
Common stock, issued shares | 27,940,267 | 26,573,023 |
Common stock, outstanding shares | 27,929,874 | 26,573,023 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Grant revenue | $2,801 | $265 | $3,347 | $799 |
Operating expenses: | ' | ' | ' | ' |
Research and development | 10,896 | 6,125 | 23,760 | 17,505 |
General and administrative | 4,931 | 2,257 | 11,044 | 6,522 |
Total operating expenses | 15,827 | 8,382 | 34,804 | 24,027 |
Loss from operations | -13,026 | -8,117 | -31,457 | -23,228 |
Other income and expense: | ' | ' | ' | ' |
Miscellaneous income | 0 | 0 | 0 | 114 |
Interest income | 20 | 2 | 65 | 6 |
Interest expense | -5 | -8 | -18 | -26 |
Other (expense) income, net | 15 | -6 | 47 | 94 |
Net loss before taxes | -13,011 | -8,123 | -31,410 | -23,134 |
Income tax benefit | 7,413 | 0 | 7,413 | 0 |
Net loss | ($5,598) | ($8,123) | ($23,997) | ($23,134) |
Basic and diluted net loss per share | ($0.20) | ($0.32) | ($0.86) | ($0.92) |
Weighted-average common shares outstanding, basic and diluted | 27,914,782 | 25,702,043 | 27,800,246 | 25,067,772 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations (Weighted-average common shares outstanding, diluted) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Weighted-average common shares outstanding, basic and diluted | 27,914,782 | 25,702,043 | 27,800,246 | 25,067,772 |
Consolidated_Statements_of_Sto
Consolidated Statements of Stockholders' Equity (Deficit) (USD $) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Deficit [Member] |
In Thousands, except Share data, unless otherwise specified | |||||
Balance at Dec. 31, 2013 | $58,327 | $266 | $194,038 | ' | ($135,977) |
Balance (shares) at Dec. 31, 2013 | 26,573,023 | ' | ' | ' | ' |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ' | ' | ' | ' | ' |
Stock issued | 27,559 | 10 | 27,549 | ' | ' |
Stock issued (shares) | 1,017,217 | ' | ' | ' | ' |
Stock Repurchased During Period | -222 | ' | ' | -222 | ' |
Stock compensation | 6,901 | ' | 6,901 | ' | ' |
Exercise of stock options | 1,590 | 3 | 1,587 | ' | ' |
Exercise of stock options (shares) | 337,217 | ' | ' | ' | ' |
Sale of shares under stock purchase plan | 233 | ' | 233 | ' | ' |
Sale of shares under stock purchase plan (shares) | 12,810 | ' | ' | ' | ' |
Treasury stock (shares) | -10,393 | ' | ' | ' | ' |
Net loss | -23,997 | ' | ' | ' | -23,997 |
Balance at Sep. 30, 2014 | $70,391 | $279 | $230,308 | $222 | ($159,974) |
Balance (shares) at Sep. 30, 2014 | 27,929,874 | ' | ' | ' | ' |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Cash Flows (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 |
Cash Flows From Development Activities | ' | ' |
Net loss | ($23,997) | ($23,134) |
Adjustments to reconcile net loss to net cash used in development activities: | ' | ' |
Share-based compensation | 6,901 | 3,134 |
Depreciation and amortization | 814 | 635 |
Changes in operating assets and liabilities: | ' | ' |
Prepaid expenses | 420 | 502 |
Income tax receivable | -7,502 | 0 |
State research and development credit receivable | -150 | -15 |
Other receivables | -1,392 | -1,027 |
Accounts payable | 2,324 | 2 |
Income taxes payable | -130 | 0 |
Accrued expenses and deferred rent | 1,103 | 2,147 |
Net cash used in operating activities | -21,609 | -17,756 |
Cash Flows From Investing Activities | ' | ' |
Purchase of certificates of deposit | 16,387 | 0 |
Sale of certificates of deposit | 0 | 1,494 |
Purchase of equipment | -1,344 | -1,280 |
Net cash used in investing activities | -17,731 | 214 |
Cash Flows From Financing Activities | ' | ' |
Issuance of common stock, net of offering costs | 29,382 | 49,423 |
Repurchase of common stock | -222 | 0 |
Proceeds from notes payable | 97 | 0 |
Principal payments on debt | -115 | -111 |
Payments under capital lease obligations | -23 | -56 |
Net cash provided by financing activities | 29,119 | 49,256 |
Net (decrease) increase in cash and cash equivalents | -10,221 | 31,714 |
Cash and cash equivalents at beginning of period | 61,291 | 20,250 |
Cash and cash equivalents at end of period | 51,070 | 51,964 |
Supplemental disclosure of cash flows information: | ' | ' |
Cash paid for interest | 18 | 25 |
Cash paid for taxes | 143 | 0 |
Noncash financing and investing activities: | ' | ' |
Purchased leasehold improvements and equipment in accounts payable | 0 | 145 |
Fair Value of Assets Acquired | $0 | $54 |
Description_of_Business_Notes
Description of Business (Notes) | 9 Months Ended |
Sep. 30, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' |
Description of Business | ' |
Description of Business | |
On June 4, 1999, NewLink Genetics Corporation (NewLink) was incorporated as a Delaware corporation. NewLink was formed for the purpose of developing treatments for cancer and other diseases. NewLink initiated operations in April of 2000, which primarily consist of research and development. | |
In 2005, NewLink created a wholly-owned subsidiary, BioProtection Systems Corporation (BPS). NewLink contributed certain licensing agreements and other intangible assets for BPS to create vaccines against potential biological terror threats. Subsequent to its creation, certain interests in BPS were sold to minority stockholders. On January 7, 2011, NewLink acquired all of the minority interest in BPS, by merging a newly-formed subsidiary of NewLink with BPS, with BPS as the surviving corporation resulting in NewLink owning all the outstanding capital stock of BPS. | |
In 2013, NewLink created a wholly-owned subsidiary, NewLink International (NI). In 2014, NewLink created another wholly-owned subsidiary, NewLink Global (NG). NewLink plans to conduct all or a portion of its operations outside of the United States through NI and NG. | |
NewLink and its subsidiaries (the Company) are devoting substantially all of their efforts toward research and development. The Company has never earned revenue from sales of its drugs. The Company incurred a net loss of $5.6 million and $24.0 million for the three and nine months ending September 30, 2014. The Company has managed its liquidity needs to date through a series of capital market transactions. On February 4, 2013, the Company completed an offering of its common stock. The Company sold 4,600,000 shares of common stock at a price of $11.40 per share raising a total of $49.0 million in net proceeds. | |
NewLink entered into a sales agreement with Cantor Fitzgerald & Co., dated as of September 5, 2013, under which NewLink may sell up to $60.0 million in shares of its common stock in one or more placements at prevailing market prices for its common stock (the ATM Offering). Any such sales would be effected pursuant to its registration statement on Form S-3 (333-185721), declared effective by the SEC on January 4, 2013. As of March 31, 2014 the Company had sold 1,833,838 shares of common stock under the ATM Offering, raising a total of $45.0 million in net proceeds. During the years ended December 31, 2013 and 2012, the Company received equity financing of $67.2 million and $1.3 million, respectively, through common stock offerings. Subsequent to March 31, 2014 and through the date of this filing, the Company sold no additional shares of common stock under the ATM Offering. | |
The accompanying financial statements as of September 30, 2014 and for the three and nine months then ended have been prepared assuming the Company will continue as a going concern. The Company successfully raised net proceeds of $37.6 million from its initial public offering in 2011, completed a follow-on offering of its common stock raising net proceeds of $49.0 million, and raised an additional $45.0 million in net proceeds from the ATM Offering prior to September 30, 2014. The Company's cash and cash equivalents and current certificates of deposit after these offerings are expected to be adequate to satisfy the Company's liquidity requirements well into 2015, although not through commercialization and launch of revenue producing products. If available liquidity becomes insufficient to meet the Company’s operating obligations as they come due, the Company's plans include pursuing alternative funding arrangements and/or reducing expenditures as necessary to meet the Company’s cash requirements. However, there is no assurance that, if required, the Company will be able to raise additional capital or reduce discretionary spending to provide the required liquidity. Failure by the Company to successfully execute its plans or otherwise address its liquidity needs may have a material adverse effect on its business and financial position, and may materially affect the Company’s ability to continue as a going concern. |
Basis_of_Presentation_Notes
Basis of Presentation (Notes) | 9 Months Ended |
Sep. 30, 2014 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' |
Basis of Presentation | ' |
Basis of Presentation | |
The interim financial statements have been prepared and presented by the Company in accordance with U.S. generally accepted accounting principles (U.S. GAAP) and the rules and regulations of the U.S. Securities and Exchange Commission (SEC), without audit, and, in management’s opinion, reflect all adjustments necessary to present fairly the Company’s interim financial information. | |
Certain information and footnote disclosures normally included in the Company’s annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The accompanying unaudited condensed financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2013, included in the Company’s Annual Report on Form 10-K. There were no significant changes in the Company’s accounting policies since the end of fiscal 2013, with the exception of those discussed below. The financial results for any interim period are not necessarily indicative of financial results for the full year. |
Significant_Accounting_Policie
Significant Accounting Policies (Notes) | 9 Months Ended |
Sep. 30, 2014 | |
Accounting Policies [Abstract] | ' |
Significant Accounting Policies | ' |
Significant Accounting Policies | |
(a) Use of Estimates | |
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. | |
(b) Principles of Consolidation | |
The consolidated financial statements include the financial statements of NewLink and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. | |
(c) Financial Instruments and Concentrations of Credit Risk | |
The fair values of cash and cash equivalents, certificates of deposit, receivables, and accounts payable, which are recorded at cost, approximate fair value based on the short-term nature of these financial instruments. The fair value and carrying value of notes payable and capital lease obligations was $1.2 million and $1.2 million as of September 30, 2014 and December 31, 2013, respectively, and was determined using Level 3 inputs. The Company is unable to estimate the fair value of the royalty obligation because the timing and receipt of payments is uncertain. Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and certificates of deposit. Cash and cash equivalents are held by financial institutions and are federally insured up to certain limits. At times, the Company’s cash and cash equivalents balance exceeds the federally insured limits. To limit the credit risk, the Company invests its excess cash primarily in high quality cash equivalents, such as money market funds, or certificates of deposit. | |
(d) Recent Accounting Pronouncements | |
On May 28, 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers, which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. The new standard is effective for the Company on January 1, 2017. Early application is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. The Company is evaluating the effect that ASU 2014-09 will have on its consolidated financial statements and related disclosures. The Company has not yet selected a transition method nor has it determined the effect of the standard on its ongoing financial reporting. | |
In June 2014, the FASB issued ASU No. 2014-10, Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements. The ASU eliminates the distinction of a development stage entity and certain related disclosure requirements, including the elimination of inception-to-date information on the statements of operations, cash flows and stockholders' equity. The amendments in the ASU will be effective prospectively for annual reporting periods beginning after December 15, 2014, and interim periods within those annual periods, however early adoption is permitted. The Company early adopted this standard effective June 30, 2014. Adoption of this standard did not have a material impact on the Company's condensed consolidated financial statements. |
LongTerm_Debt_Notes
Long-Term Debt (Notes) | 9 Months Ended |
Sep. 30, 2014 | |
Debt Disclosure [Abstract] | ' |
Long-Term Debt | ' |
Long-Term Debt | |
March 2010 City of Ames Forgivable Loan | |
In March 2010, the Company entered into a $400,000 forgivable loan agreement with the City of Ames, Iowa and the Ames Chamber of Commerce, jointly, as lenders. The project provides the Company with financial assistance to construct new facilities within the Ames city limits. In the absence of a default, there are no principal or interest payments due until the expected completion date for the project, which is March 10, 2015. | |
The project calls for the Company to create or retain at least 150 full-time positions located in Ames, Iowa as of March 10, 2015. The agreement also calls for the Company to enter into a five-year building lease with the option for extension for an additional five years of not less than 20,000 square feet within the corporate limits of the City of Ames by March 10, 2015. If, as of March 10, 2015, the Company has fulfilled the terms of the loan agreement, the loan will be forgiven. If on March 10, 2015, the Company has failed to create or retain at least 150 full-time jobs in Ames, Iowa, the Company will be required to repay approximately $3,100 per job not created or retained following such date. As of September 30, 2014, $397,000 of the total $400,000 forgivable loan was advanced to the Company. In the event of default, including failure to repay any amounts under the loan when due, the Company will be required to repay the note, including 6.5% interest per annum, beginning at the date of default. |
Common_Stock_Equity_Incentive_
Common Stock Equity Incentive Plan (Notes) | 9 Months Ended | |||||||||
Sep. 30, 2014 | ||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | |||||||||
Common Stock Equity Incentive Plan | ' | |||||||||
Common Stock Equity Incentive Plan | ||||||||||
In April 2000, the stockholders approved the Company's 2000 Equity Incentive Plan (the “2000 Plan”), and in July 2009, the stockholders approved the Company's 2009 Equity Incentive Plan (the “2009 Plan”). Following the approval of the 2009 Plan, all options outstanding under the 2000 Plan are effectively included under the 2009 Plan. Under the provisions of the 2009 Plan, the Company may grant the following types of common stock awards: | ||||||||||
• | Incentive Stock Options | |||||||||
• | Nonstatutory Stock Options | |||||||||
• | Restricted Stock Awards | |||||||||
• | Stock Appreciation Rights | |||||||||
Awards under the 2009 Plan, as amended, may be made to officers, employees, members of the Board of Directors, advisors, and consultants to the Company. Shares are added to the reserve of shares available for issuance pursuant to an “evergreen provision” on January 1 of each year, from 2012 to (and including) 2019, in an amount equal to 4% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year. As of September 30, 2014, there were 6,799,854 shares of common stock authorized for the 2009 plan and 1,056,883 shares remained available for issuance. | ||||||||||
On January 1, 2013, an additional 838,375 shares of common stock were added to the shares reserved for future issuance under the 2009 Plan. On January 1, 2014 an additional 1,066,340 shares of common stock were added to the shares reserved for future issuance under the 2009 Plan. | ||||||||||
Under the terms of the Company’s 2010 Non-Employee Directors’ Stock Award Plan (Directors’ Plan), which became effective on November 10, 2011, 238,095 shares of common stock were reserved for future issuance. On May 9, 2013, an additional 161,905 shares of common stock were added to the shares reserved for future issuance under the Directors' Plan. As of September 30, 2014, 207,327 shares remained available for issuance under the plan. | ||||||||||
Under the terms of the Company’s 2010 Employee Stock Purchase Plan (2010 Purchase Plan), which became effective on November 10, 2011, 214,285 shares of common stock were reserved for future issuance. On May 9, 2013 an additional 185,715 shares of common stock were added to the shares reserved for future issuance under the 2010 Purchase Plan. As of September 30, 2014, 283,998 shares remained available for issuance under the plan. | ||||||||||
Share-based Compensation | ||||||||||
Share-based compensation expense for the three and nine months ended September 30, 2014 and the three and nine months ended September 30, 2013 was $3.3 million, $6.9 million, $1.1 million, and $3.1 million, respectively, and is allocated between research and development and general and administrative expenses within the consolidated statements of operations, giving rise to related tax benefits for the three and nine months ended September 30, 2014 and the three and nine months ended September 30, 2013 of $782,000, $1.6 million, $0 and $0, respectively. | ||||||||||
As of September 30, 2014, the total compensation cost related to nonvested option awards not yet recognized was $11.4 million and the weighted average period over which it is expected to be recognized is 2.8 years. | ||||||||||
The following table summarizes the stock option activity for the nine months ended September 30, 2014: | ||||||||||
Number | Weighted | Weighted | ||||||||
of options | average | average | ||||||||
exercise | remaining | |||||||||
price | contractual | |||||||||
term (years) | ||||||||||
Outstanding at beginning of period | 4,486,564 | $ | 5.89 | |||||||
Options granted | 628,805 | 23.26 | ||||||||
Options exercised | (291,517 | ) | 5.45 | |||||||
Options forfeited | (27,545 | ) | 16.21 | |||||||
Options expired | — | — | ||||||||
Outstanding at end of period | 4,796,307 | $ | 8.14 | 6.3 | ||||||
Options exercisable at end of period | 3,601,927 | $ | 5.31 | 5.5 | ||||||
The following table summarizes options that were granted during the nine months ended September 30, 2014, and the range of assumptions used to estimate the fair value of those stock options using a Black-Scholes valuation model: | ||||||||||
Risk-free interest rate | 1.86%-2.24% | |||||||||
Expected dividend yield | —% | |||||||||
Expected volatility | 57.4%-63.5% | |||||||||
Expected term (in years) | 6.0-7.0 | |||||||||
Weighted average grant-date fair value per share | $13.67 | |||||||||
The intrinsic value of options exercised during the nine months ended September 30, 2014 was $7.3 million. The fair value of awards vested during the nine months ended September 30, 2014 was $6.5 million, which includes $1.7 million in share-based compensation resulting from the vesting in full of one employee's options upon the employee's termination that occurred during the three months ended September 30, 2014. | ||||||||||
Restricted stock is common stock that is subject to restrictions, including risks of forfeiture, determined by the plan committee of the Board of Directors in its sole discretion, for so long as such common stock remains subject to any such restrictions. A holder of restricted stock has all rights of a stockholder with respect to such stock, including the right to vote and to receive dividends thereon, except as otherwise provided in the award agreement relating to such award. Restricted stock awards are equity classified within the consolidated balance sheets. The fair value of each restricted stock grant is estimated on the date of grant using the closing price of Company's Common Stock on the The NASDAQ Stock Market on the date of grant. | ||||||||||
During the nine months ended September 30, 2014 and 2013, respectively, there were 138,420 and 0 shares of restricted stock granted. These restricted stock grants had a weighted average fair value (per share) at date of grant of $21.82. At September 30, 2014, and December 31, 2013, there were 92,720 and 0 shares of unvested restricted stock outstanding, respectively. Compensation expense is determined for the issuance of restricted stock by amortizing over the requisite service period, or the vesting period, the aggregate fair value of the restricted stock awarded based on the closing price of the Company’s common stock on the date of grant. | ||||||||||
A summary of the Company’s unvested restricted stock at September 30, 2014 and changes during the nine months ended September 30, 2014 is as follows: | ||||||||||
Restricted Stock | Weighted Average Grant Date Fair Value | |||||||||
Unvested at December 31, 2013 | — | $ | — | |||||||
Granted | 138,420 | 21.82 | ||||||||
Vested | (45,700 | ) | 21.38 | |||||||
Forfeited/cancelled | — | — | ||||||||
Unvested restricted stock at September 30, 2014 | 92,720 | $ | 22.04 | |||||||
As of September 30, 2014, the total remaining unrecognized compensation cost related to issuances of restricted stock was approximately $1.6 million and is expected to be recognized over a weighted-average period of 3.0 years. |
Income_Taxes_Notes
Income Taxes (Notes) | 9 Months Ended |
Sep. 30, 2014 | |
Income Tax Disclosure [Abstract] | ' |
Income Taxes | ' |
Income Taxes | |
For the nine months ended September 30, 2014 and 2013, the Company incurred an income tax benefit of $7.4 million and $0, respectively. In October 2014, the Company entered into an exclusive worldwide license agreement with Genentech, Inc., a member of the Roche Group, or Genentech, for the development and commercialization of NLG919, the Company's IDO (indoleamine 2.3 dioxygenase) pathway inhibitor and a research collaboration for the discovery of next generation IDO and TDO (tryptophan-2.3 dioxygenase) pathway inhibitors, or the Genentech Agreement. The Company's estimated effective annual tax rate at September 30, 2014 has changed from zero due to the projected impact of the Genentech Agreement. Income tax benefit for the nine months ended September 30, 2014, differs from the amount that would be expected after applying the statutory U.S. federal income tax rate primarily due to the Company's anticipation of entering into the Genentech Agreement and other permanent differences. Income tax expense for the nine months ended September 30, 2013 differs from the amount that would be expected after applying the statutory U.S. federal income tax rate primarily due to the changes in the valuation allowance for deferred taxes. | |
The valuation allowance for deferred tax assets as of September 30, 2014 and December 31, 2013 was $26.1 million and $25.2 million, respectively. The net change in the total valuation allowance for the nine months ended September 30, 2014 and 2013 was an increase of $900,000 and $5.7 million, respectively. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected taxable income, and tax planning strategies in making this assessment. Valuation allowances have been established for the entire amount of the net deferred tax assets as of September 30, 2014 and December 31, 2013, due to the uncertainty of future recoverability. | |
Based on analysis from inception through December 31, 2013, NewLink experienced Section 382 ownership changes in September 2001 and March 2003 and BPS experienced Section 382 ownership changes in January 2006 and January 2011. These ownership changes limit NewLink’s ability to utilize federal net operating loss carryforwards (and certain other tax attributes) that accrued prior to the respective ownership changes of NewLink and BPS. Additional ownership changes may have occurred subsequent to December 31, 2013 and may occur in the future as a result of events over which the Company will have little or no control, including purchases and sales of the Company’s equity by its 5% stockholders, the emergence of new 5% stockholders, additional equity offerings or redemptions of the Company’s stock or certain changes in the ownership of any of the Company’s 5% stockholders. | |
Additional analysis will be required to determine whether changes in the Company's ownership since December 31, 2013 have occurred. Any such change could result in significant limitations on some or all of the Company's net operating loss carryforwards and other tax attributes. | |
Even if another ownership change has not occurred, additional ownership changes may occur in the future as a result of events over which the Company will have little or no control, including purchases and sales of the Company's equity by its 5% stockholders, the emergence of new 5% stockholders, additional equity offerings or redemptions of the Company's stock or certain changes in the ownership of any of its 5% stockholders. |
Net_Loss_per_Common_Share_Note
Net Loss per Common Share (Notes) | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Earnings Per Share [Abstract] | ' | |||||||||||||||
Net Loss per Common Share | ' | |||||||||||||||
Net Loss per Common Share | ||||||||||||||||
Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted average number of common share equivalents outstanding for the period determined using the treasury-stock method. For purposes of this calculation, preferred stock, stock options and warrants are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. | ||||||||||||||||
The following table presents the computation of basic and diluted net loss per common share (in thousands, except share and per share data): | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Historical net loss per share | ||||||||||||||||
Numerator | ||||||||||||||||
Net loss attributable to common stockholders | (5,598 | ) | (8,123 | ) | (23,997 | ) | (23,134 | ) | ||||||||
Denominator | ||||||||||||||||
Weighted-average common shares outstanding (basic and diluted) | 27,914,782 | 25,702,043 | 27,800,246 | 25,067,772 | ||||||||||||
Basic and diluted net loss per share | $ | (0.20 | ) | $ | (0.32 | ) | $ | (0.86 | ) | $ | (0.92 | ) | ||||
As of September 30, 2014 and 2013 respectively, 4.9 million and 4.5 million common equivalent shares of potentially dilutive securities were not included in the calculation of diluted net loss per common share because to do so would be anti-dilutive. |
Commitments_and_Contingencies_
Commitments and Contingencies (Notes) | 9 Months Ended |
Sep. 30, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ' |
Commitments and Contingencies Disclosure | ' |
Commitments and Contingencies | |
In June 2014, the Company entered into a Development and Manufacturing Terms and Conditions and a Development and Process Transfer Program Leading to Commercial Manufacturing for algenpantucel-L HyperAcute Pancreas with WuXi AppTec, Inc., or WuXi, or collectively, the WuXi Agreement. The WuXi Agreement is intended to establish a source of supply for algenpantucel-L for commercial sale, if and when that drug is approved by the FDA. Under the WuXi Agreement, the Company granted WuXi a non-exclusive right to use certain starting materials and the Company's confidential information to develop manufacturing processes and to manufacture cell material to be formulated into algenpantucel-L. WuXi will adapt facilities and equipment for production, generate batch records and other documents, perform studies and test manufacturing runs and conduct process validation and characterization. | |
In August 2014, the Company signed a letter agreement with the United States Defense Threat Reduction Agency, or DTRA, under which the Company will conduct studies with the goal of bringing an Ebola vaccine product candidate licensed from the Public Health Agency of Canada closer to human clinical trials. The agreement provided funding of $1.0 million with additional funding subject to final negotiation and will fund Investigational New Drug (IND)-enabling preclinical toxicology studies and includes the manufacture of clinical materials. In September 2014, the agreement was modified to increase the amount of funding available prior to final agreement by an additional $1.9 million, bringing the total pre-contract funding to $2.9 million. Under the agreement, the Company may bill DTRA for 85% of the costs it incurs, and once the final contract is signed, the Company may bill DTRA for the remaining 15% of the costs. The Company has committed resources in excess of $8.4 million to further these studies. | |
In October 2014, the Company entered into the Genentech Agreement, which provides for the development of NLG919, the Company's IDO pathway inhibitor. The parties also entered into a research collaboration for the discovery of next generation IDO/TDO compounds. Under the terms of the agreement, the Company will receive an upfront non-refundable payment of $150.0 million. The Company will be eligible to receive in excess of $1 billion in milestone payments based on achievement of certain predetermined milestones as well as escalating royalties on potential commercial sales of multiple products by Genentech. |
Significant_Accounting_Policie1
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2014 | |
Accounting Policies [Abstract] | ' |
Use of Estimates | ' |
Use of Estimates | |
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. | |
Principles of Consolidation | ' |
Principles of Consolidation | |
The consolidated financial statements include the financial statements of NewLink and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation. | |
Financial Instruments | ' |
Financial Instruments and Concentrations of Credit Risk | |
The fair values of cash and cash equivalents, certificates of deposit, receivables, and accounts payable, which are recorded at cost, approximate fair value based on the short-term nature of these financial instruments. The fair value and carrying value of notes payable and capital lease obligations was $1.2 million and $1.2 million as of September 30, 2014 and December 31, 2013, respectively, and was determined using Level 3 inputs. The Company is unable to estimate the fair value of the royalty obligation because the timing and receipt of payments is uncertain. | |
Concentration of Credit Risk | ' |
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and certificates of deposit. Cash and cash equivalents are held by financial institutions and are federally insured up to certain limits. At times, the Company’s cash and cash equivalents balance exceeds the federally insured limits. To limit the credit risk, the Company invests its excess cash primarily in high quality cash equivalents, such as money market funds, or certificates of deposit | |
Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements | |
On May 28, 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers, which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. The new standard is effective for the Company on January 1, 2017. Early application is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. The Company is evaluating the effect that ASU 2014-09 will have on its consolidated financial statements and related disclosures. The Company has not yet selected a transition method nor has it determined the effect of the standard on its ongoing financial reporting. | |
In June 2014, the FASB issued ASU No. 2014-10, Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements. The ASU eliminates the distinction of a development stage entity and certain related disclosure requirements, including the elimination of inception-to-date information on the statements of operations, cash flows and stockholders' equity. The amendments in the ASU will be effective prospectively for annual reporting periods beginning after December 15, 2014, and interim periods within those annual periods, however early adoption is permitted. The Company early adopted this standard effective June 30, 2014. Adoption of this standard did not have a material impact on the Company's condensed consolidated financial statements. |
Common_Stock_Equity_Incentive_1
Common Stock Equity Incentive Plan (Tables) | 9 Months Ended | |||||||||
Sep. 30, 2014 | ||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ' | |||||||||
Stock Option Activity | ' | |||||||||
The following table summarizes the stock option activity for the nine months ended September 30, 2014: | ||||||||||
Number | Weighted | Weighted | ||||||||
of options | average | average | ||||||||
exercise | remaining | |||||||||
price | contractual | |||||||||
term (years) | ||||||||||
Outstanding at beginning of period | 4,486,564 | $ | 5.89 | |||||||
Options granted | 628,805 | 23.26 | ||||||||
Options exercised | (291,517 | ) | 5.45 | |||||||
Options forfeited | (27,545 | ) | 16.21 | |||||||
Options expired | — | — | ||||||||
Outstanding at end of period | 4,796,307 | $ | 8.14 | 6.3 | ||||||
Options exercisable at end of period | 3,601,927 | $ | 5.31 | 5.5 | ||||||
Assumptions Used in Black-Scholes Pricing Model for New Grants | ' | |||||||||
The following table summarizes options that were granted during the nine months ended September 30, 2014, and the range of assumptions used to estimate the fair value of those stock options using a Black-Scholes valuation model: | ||||||||||
Risk-free interest rate | 1.86%-2.24% | |||||||||
Expected dividend yield | —% | |||||||||
Expected volatility | 57.4%-63.5% | |||||||||
Expected term (in years) | 6.0-7.0 | |||||||||
Weighted average grant-date fair value per share | $13.67 | |||||||||
Restricted Stock Activity | ' | |||||||||
A summary of the Company’s unvested restricted stock at September 30, 2014 and changes during the nine months ended September 30, 2014 is as follows: | ||||||||||
Restricted Stock | Weighted Average Grant Date Fair Value | |||||||||
Unvested at December 31, 2013 | — | $ | — | |||||||
Granted | 138,420 | 21.82 | ||||||||
Vested | (45,700 | ) | 21.38 | |||||||
Forfeited/cancelled | — | — | ||||||||
Unvested restricted stock at September 30, 2014 | 92,720 | $ | 22.04 | |||||||
Net_Loss_per_Common_Share_Tabl
Net Loss per Common Share (Tables) | 9 Months Ended | |||||||||||||||
Sep. 30, 2014 | ||||||||||||||||
Earnings Per Share [Abstract] | ' | |||||||||||||||
Basic and Diluted Net Loss per Common Share | ' | |||||||||||||||
The following table presents the computation of basic and diluted net loss per common share (in thousands, except share and per share data): | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Historical net loss per share | ||||||||||||||||
Numerator | ||||||||||||||||
Net loss attributable to common stockholders | (5,598 | ) | (8,123 | ) | (23,997 | ) | (23,134 | ) | ||||||||
Denominator | ||||||||||||||||
Weighted-average common shares outstanding (basic and diluted) | 27,914,782 | 25,702,043 | 27,800,246 | 25,067,772 | ||||||||||||
Basic and diluted net loss per share | $ | (0.20 | ) | $ | (0.32 | ) | $ | (0.86 | ) | $ | (0.92 | ) |
Description_of_Business_Detail
Description of Business (Details) (USD $) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | Nov. 16, 2011 | Sep. 05, 2013 | Feb. 04, 2013 | Sep. 30, 2014 | |
Initial Public Offering | Follow-on Offering | Follow-on Offering | ATM Offering | |||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net loss | ($5,598,000) | ($8,123,000) | ($23,997,000) | ($23,134,000) | ' | ' | ' | ' | ' | ' |
Financings | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
FInancing proceeds | ' | ' | ' | ' | ' | ' | 37,600,000 | 60,000,000 | 49,000,000 | 45,000,000 |
Financing price per share | ' | ' | ' | ' | ' | ' | ' | ' | $11.40 | ' |
Financing shares | ' | ' | ' | ' | ' | ' | ' | ' | 4,600,000 | 1,833,838 |
Financing received | ' | ' | ' | ' | $67,200,000 | $1,300,000 | ' | ' | ' | ' |
Significant_Accounting_Policie2
Significant Accounting Policies (Details) (Reported Value Measurement, USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Millions, unless otherwise specified | ||
Reported Value Measurement | ' | ' |
Financial Instruments, Financial Liabilities, Balance Sheet Groupings | ' | ' |
Financial and Nonfinancial Liabilities, Fair Value Disclosure | $1.20 | $1.20 |
Details
(Details) (Amount, City of Ames Forgivable Loan 2010, USD $) | Sep. 30, 2014 |
Amount | City of Ames Forgivable Loan 2010 | ' |
Debt Instrument | ' |
Outstanding Balance | $397,000 |
Original Available Balance | 400,000 |
Interest rate in default | 6.50% |
Jobs by March 10, 2015 | 150 |
Lease square feet | 20,000 |
Repayment per job | $3,100 |
Common_Stock_Equity_Incentive_2
Common Stock Equity Incentive Plan (Details) (USD $) | 3 Months Ended | 9 Months Ended | 12 Months Ended | 9 Months Ended | |||||||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | |
Stock Option | Restricted Stock | Restricted Stock | Minimum | Maximum | 2009 Equity Incentive Plan | 2009 Equity Incentive Plan | 2010 Employee Stock Purchase Plan | 2010 Non-Employee Directors' Stock Option Plan | |||||
Stock Option | Stock Option | ||||||||||||
Common Stock Equity Incentive Plan | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of Shares Authorized | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6,799,854 | ' | 214,285 | 238,095 |
Number of Shares Available for Grant | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,056,883 | ' | 283,998 | 207,327 |
Increase in Number of Shares Authorized | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,066,340 | 838,375 | 185,715 | 161,905 |
Evergreen Increase Percentage | ' | ' | ' | ' | ' | ' | ' | ' | ' | 4.00% | ' | ' | ' |
Total Compensation Cost Related to Non-vested Option Awards | ' | ' | ' | ' | $11,400,000 | $1,600,000 | ' | ' | ' | ' | ' | ' | ' |
Weighted Average Vesting Period for Non-vested Option Awards, In Years | ' | ' | ' | ' | 2.8 | 3 | ' | ' | ' | ' | ' | ' | ' |
Share-based Compensation Expense | 3,300,000 | 1,100,000 | 6,900,000 | 3,100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Income Tax Benefit from Compensation Expense | 782,000 | 0 | 1,600,000 | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Intrinsic Value of Options Exercised | ' | ' | ' | ' | 7,300,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Fair Value of Awards Vested | ' | ' | ' | ' | 6,500,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Additional Share-Based Compensation | $1,700,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Assumptions Used in Black Scholes Pricing Model for New Grants | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Risk Free Interest Rate | ' | ' | ' | ' | ' | ' | ' | 1.86% | 2.24% | ' | ' | ' | ' |
Dividend Rate | ' | ' | ' | ' | ' | ' | ' | 0.00% | 0.00% | ' | ' | ' | ' |
Volatility Rate | ' | ' | ' | ' | ' | ' | ' | 57.40% | 63.50% | ' | ' | ' | ' |
Expected Term (in years) | ' | ' | ' | ' | ' | ' | ' | 6 | 7 | ' | ' | ' | ' |
Weighted average grant-date fair value per share | ' | ' | ' | ' | $13.67 | $21.82 | ' | ' | ' | ' | ' | ' | ' |
Stock Option Activity | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Outstanding at beginning of period | ' | ' | ' | ' | 4,486,564 | 0 | ' | ' | ' | ' | ' | ' | ' |
Outstanding at beginning of period, weighted average exercise price | ' | ' | ' | ' | $5.89 | $0 | ' | ' | ' | ' | ' | ' | ' |
Grants | ' | ' | ' | ' | 628,805 | 138,420 | 0 | ' | ' | ' | ' | ' | ' |
Grants, weighted average exercise price | ' | ' | ' | ' | $23.26 | $21.82 | ' | ' | ' | ' | ' | ' | ' |
Vested | ' | ' | ' | ' | ' | -45,700 | ' | ' | ' | ' | ' | ' | ' |
Vested, weighted average exercise price | ' | ' | ' | ' | ' | $21.38 | ' | ' | ' | ' | ' | ' | ' |
Exercises | ' | ' | -337,217 | ' | -291,517 | ' | ' | ' | ' | ' | ' | ' | ' |
Exercises, weighted average exercise price | ' | ' | ' | ' | $5.45 | ' | ' | ' | ' | ' | ' | ' | ' |
Forfeitures | ' | ' | ' | ' | -27,545 | 0 | ' | ' | ' | ' | ' | ' | ' |
Forfeitures, weighted average exercise price | ' | ' | ' | ' | $16.21 | $0 | ' | ' | ' | ' | ' | ' | ' |
Expirations | ' | ' | ' | ' | 0 | ' | ' | ' | ' | ' | ' | ' | ' |
Expirations, weighted average exercise price | ' | ' | ' | ' | $0 | ' | ' | ' | ' | ' | ' | ' | ' |
Outstanding at end of period | ' | ' | ' | ' | 4,796,307 | 92,720 | ' | ' | ' | ' | ' | ' | ' |
Outstanding at end of period, weighted average exercise price | ' | ' | ' | ' | $8.14 | $22.04 | ' | ' | ' | ' | ' | ' | ' |
Outstanding at end of period, weighted average remaining contractual term, in years | ' | ' | ' | ' | 6.3 | ' | ' | ' | ' | ' | ' | ' | ' |
Exercisable | ' | ' | ' | ' | 3,601,927 | ' | ' | ' | ' | ' | ' | ' | ' |
Exercisable, weighted average exercise price | ' | ' | ' | ' | $5.31 | ' | ' | ' | ' | ' | ' | ' | ' |
Exercisable, weighted average remaining contractual term, in years | ' | ' | ' | ' | 5.5 | ' | ' | ' | ' | ' | ' | ' | ' |
Income_Taxes_Details
Income Taxes (Details) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | |
Income Tax Disclosure [Abstract] | ' | ' | ' | ' | ' |
Income tax benefit | $7,413,000 | $0 | $7,413,000 | $0 | ' |
Deferred Tax Valuation Allowance | -26,100,000 | ' | -26,100,000 | ' | -25,200,000 |
Change in Deferred Tax Valuation Allowance | ' | ' | $900,000 | $5,700,000 | ' |
Net_Loss_per_Common_Share_Net_
Net Loss per Common Share (Net Loss Per Share Computation) (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Earnings Per Share [Abstract] | ' | ' | ' | ' |
Net loss attributable to common stockholders | ($5,598) | ($8,123) | ($23,997) | ($23,134) |
Weighted-average number of common share outstanding, basic and diluted | 27,914,782 | 25,702,043 | 27,800,246 | 25,067,772 |
Basic and diluted net loss per share | ($0.20) | ($0.32) | ($0.86) | ($0.92) |
Net_Loss_per_Common_Share_Anti
Net Loss per Common Share (Antidilutive Securities) (Details) | 9 Months Ended | |
In Millions, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 |
Antidilutive Securities Excluded from Computation of Earnings Per Share | ' | ' |
Potentially dilutive securities excluded from computation of diluted net loss per share | 4.9 | 4.5 |
Commitments_and_Contingencies_1
Commitments and Contingencies (Details) (USD $) | Sep. 30, 2014 |
Commitments and Contingencies Disclosure [Abstract] | ' |
Letter Contract Amount | $1,000,000 |
Letter Contract Amount Increase | 1,900,000 |
Letter Contract Amount Revised | 2,900,000 |
DTRA Initial Billing Percentage | 85.00% |
DTRA Remaining Billing Percentage | 15.00% |
Letter Contract and Other Commitments | 8,400,000 |
Genentech Upfront Payment | 150,000,000 |
Genentech Potential Milestones | $1,000,000,000 |