Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Feb. 24, 2017 | Jun. 30, 2016 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | CEMP | ||
Entity Registrant Name | CEMPRA, INC. | ||
Entity Central Index Key | 1,461,993 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Public Float | $ 655.8 | ||
Entity Common Stock, Shares Outstanding | 52,392,905 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Current assets | ||
Cash and equivalents | $ 231,553 | $ 153,765 |
Receivables | 6,162 | 7,639 |
Prepaid expenses | 579 | 573 |
Total current assets | 238,294 | 161,977 |
Furniture, fixtures and equipment, net | 48 | 90 |
Deposits | 173 | 73 |
Total assets | 238,515 | 162,140 |
Current liabilities | ||
Accounts payable | 15,657 | 9,635 |
Accrued expenses | 2,929 | 1,475 |
Accrued payroll and benefits | 4,267 | 2,337 |
Current portion of long-term debt | 6,667 | 4,444 |
Total current liabilities | 29,520 | 17,891 |
Deferred revenue | 16,987 | 11,326 |
Long-term debt | 8,660 | 15,258 |
Total liabilities | 55,167 | 44,475 |
Commitments and Contingencies (Notes 4 and 8) | ||
Shareholders' Equity | ||
Preferred stock; $.001 par value; 5,000,000 shares authorized; no shares issued or outstanding at December 31, 2016 and December 31, 2015 | ||
Common stock; $.001 par value; 80,000,000 shares authorized; 52,392,905 and 43,990,751 issued and outstanding at December 31, 2016 and December 31, 2015, respectively | 52 | 44 |
Additional paid-in capital | 620,279 | 436,643 |
Accumulated deficit | (436,983) | (319,022) |
Total shareholders’ equity | 183,348 | 117,665 |
Total liabilities and shareholders’ equity | $ 238,515 | $ 162,140 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 80,000,000 | 80,000,000 |
Common stock, shares issued | 52,392,905 | 43,990,751 |
Common stock, shares outstanding | 52,392,905 | 43,990,751 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenue | |||
Contract research | $ 13,677 | $ 12,448 | $ 9,609 |
License | 4,339 | 10,000 | 4,339 |
Supply | 4,860 | 1,268 | |
Total revenue | 18,016 | 27,308 | 15,216 |
Operating expenses | |||
Research and development | 81,686 | 93,353 | 62,539 |
General and administrative | 53,538 | 22,871 | 12,077 |
Total costs and expenses | 135,224 | 116,224 | 74,616 |
Loss from operations | (117,208) | (88,916) | (59,400) |
Other income (expenses) | |||
Interest income | 475 | 9 | 134 |
Interest expense | (1,228) | (2,206) | (2,383) |
Other income (expense), net | (753) | (2,197) | (2,249) |
Net loss | $ (117,961) | $ (91,113) | $ (61,649) |
Basic and diluted net loss per share | $ (2.34) | $ (2.09) | $ (1.81) |
Basic and diluted weighted average shares outstanding | 50,313,614 | 43,565,518 | 34,130,901 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Beginning balance at Dec. 31, 2013 | $ 69,975 | $ 33 | $ 236,202 | $ (166,260) |
Beginning balance, shares at Dec. 31, 2013 | 33,200,341 | |||
Share-based compensation | 3,105 | 3,105 | ||
Issuance of common shares upon exercise of options and warrants | 351 | 351 | ||
Issuance of common shares upon exercise of options and warrants, shares | 182,078 | |||
Issuance of common stock, net of offering costs | 48,438 | $ 4 | 48,434 | |
Issuance of common stock, net of offering costs, shares | 4,092,525 | |||
Reclassification of additional paid-in capital to warrant liability | 801 | 801 | ||
Net loss | (61,649) | (61,649) | ||
Ending balance at Dec. 31, 2014 | 61,021 | $ 37 | 288,893 | (227,909) |
Ending balance, shares at Dec. 31, 2014 | 37,474,944 | |||
Share-based compensation | 5,888 | 5,888 | ||
Issuance of common shares upon exercise of options and warrants | 3,039 | $ 1 | 3,038 | |
Issuance of common shares upon exercise of options and warrants, shares | 478,307 | |||
Issuance of common stock, net of offering costs | 138,830 | $ 6 | 138,824 | |
Issuance of common stock, net of offering costs, shares | 6,037,500 | |||
Net loss | (91,113) | (91,113) | ||
Ending balance at Dec. 31, 2015 | 117,665 | $ 44 | 436,643 | (319,022) |
Ending balance, shares at Dec. 31, 2015 | 43,990,751 | |||
Share-based compensation | 14,323 | 14,323 | ||
Issuance of common shares upon exercise of options and warrants | 493 | 493 | ||
Issuance of common shares upon exercise of options and warrants, shares | 95,180 | |||
Issuance of common stock, net of offering costs | 168,828 | $ 8 | 168,820 | |
Issuance of common stock, net of offering costs, shares | 8,306,974 | |||
Net loss | (117,961) | (117,961) | ||
Ending balance at Dec. 31, 2016 | $ 183,348 | $ 52 | $ 620,279 | $ (436,983) |
Ending balance, shares at Dec. 31, 2016 | 52,392,905 |
Consolidated Statements of Sha6
Consolidated Statements of Shareholders' Equity (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
IPO | |||
Issuance cost | $ 0.3 | $ 0.2 | $ 0.1 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Operating activities | |||
Net loss | $ (117,961) | $ (91,113) | $ (61,649) |
Adjustments to reconcile net loss to net cash used in operating activities | |||
Depreciation | 51 | 69 | 77 |
Share-based compensation | 14,323 | 5,888 | 3,105 |
Change in fair value of warrant liabilities | (120) | ||
Amortization of debt issuance costs | 69 | 400 | 767 |
Loss on extinguishment of debt | 153 | ||
Changes in operating assets and liabilities | |||
Receivables | 1,477 | (5,289) | (724) |
Prepaid expenses | (6) | 2,815 | (2,980) |
Deposits | (100) | 273 | (13) |
Accounts payable | 6,022 | (2,259) | 5,620 |
Accrued expenses | 1,454 | 473 | 611 |
Accrued payroll and benefits | 1,930 | 741 | 553 |
Deferred revenue | 5,661 | 5,661 | |
Net cash used in operating activities | (87,080) | (87,849) | (49,092) |
Investing activities | |||
Purchases of furniture, fixtures and equipment | (9) | (46) | (52) |
Net cash used in investing activities | (9) | (46) | (52) |
Financing activities | |||
Proceeds from borrowing on long-term debt | 20,000 | 3,000 | |
Payments on long-term debt | (4,444) | (18,995) | |
Payment of debt issuance costs | (327) | (35) | |
Proceeds from exercise of stock options and warrants | 493 | 3,038 | 351 |
Proceeds from issuance of common stock, net of underwriting discounts | 169,112 | 139,044 | 48,535 |
Payment of offering costs | (284) | (213) | (97) |
Net cash provided by financing activities | 164,877 | 142,547 | 51,754 |
Net change in cash and equivalents | 77,788 | 54,652 | 2,610 |
Cash and equivalents at beginning of the period | 153,765 | 99,113 | 96,503 |
Cash and equivalents at end of the period | 231,553 | 153,765 | 99,113 |
Supplemental cash flow information | |||
Cash paid for interest | $ 1,177 | $ 1,527 | 1,579 |
Non-cash investing and financing activities | |||
Reclassification of warrant liability to additional paid-in capital | $ 801 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of Business | 1. Description of Business Cempra, Inc. (the “Company” or “Cempra”, previously known as Cempra Holdings, LLC) is the successor entity of Cempra Pharmaceuticals, Inc. which was incorporated on November 18, 2005 and commenced operations in January 2006. Cempra is located in Chapel Hill, North Carolina, and is a pharmaceutical company developing medicines to treat drug-resistant bacterial infections in the hospital and community. The Company expects to continue to incur losses and require additional financial resources to advance its products to either commercial stage or liquidity events. There can be no assurance that the Company will be able to obtain additional financial resources such as debt or equity financing or generate revenues from collaborative partners, on terms acceptable to the Company, on a timely basis or at all. The failure of the Company to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on the Company’s business, results of operations and financial condition. Based on current assumptions, the Company believes that its existing cash and equivalents will enable it to fund its current operating expenses and capital requirements for at least the next 12 months from the filing date of this report. |
Basis of Presentation
Basis of Presentation | 12 Months Ended |
Dec. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | 2. Basis of Presentation Principles of Consolidation and Basis of Presentation The accompanying consolidated financial statements include the accounts and results of operations of Cempra and its wholly owned subsidiaries. The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of these 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 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. Cash Equivalents and Concentrations of Risks The Company considers all highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash deposits are all in financial institutions in the U.S. The Company maintains cash in accounts which are in excess of federally insured limits. The Company places cash and equivalents in financial institutions with high credit ratings. Receivables Receivables consist of amounts billed and amounts earned but unbilled under the Company’s licensing agreements or its contract with the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services (“BARDA”) Furniture, Fixtures and Equipment, net Furniture, fixtures and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Furniture, fixtures, equipment and leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is credited or charged to income. Repairs and maintenance costs are expensed as incurred. Furniture, fixtures and equipment are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. If there is an impairment, a loss is recognized. Income Taxes Income taxes are computed using the asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s financial statements. In estimating future tax consequences, the Company considers all expected future events other than enactment of changes in tax laws or rates. A valuation allowance is recorded, if necessary, to reduce net deferred tax assets to their realizable values if management does not believe it is more likely than not that the net deferred tax assets will be realized. Segment and Geographic Information Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company operates and manages its business as one operating segment and all of the Company’s operations are in North America. Intellectual Property The Company’s policy is to file patent applications to protect technology, inventions and improvements that are considered important to the development of its business. The patent positions of technology companies, including the Company, are uncertain and involve complex legal and factual questions for which important legal principles are largely unresolved. The Company accounts for its intellectual property under the guidance of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 350, Intangibles—Goodwill and Other. Research and Development Expenses Research and development (“R&D”) expenses include direct and indirect R&D costs. Direct R&D consists principally of external costs, such as fees paid to investigators, consultants, central laboratories and clinical research organizations, including costs incurred in connection with clinical trials, and related clinical trial fees and all employee-related expenses for those employees working in research and development functions, including stock-based compensation for R&D personnel. Indirect R&D costs include insurance or other indirect costs related to the Company’s research and development function to specific product candidates. R&D costs are expensed as incurred. Expenses paid but not yet incurred are recorded in prepaid expenses. The Company expenses pre-approval inventory as R&D until regulatory approval is received. Clinical Trial Accruals As part of the process of preparing financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with conducting clinical trials. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates through discussions with applicable personnel and outside service providers as to the progress of trials, or the services completed. During the course of a clinical trial, the Company adjusts its rate of clinical trial expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. The Company’s clinical trial accrual is dependent upon the timely and accurate reporting of fee billings and pass-through expenses from contract research organizations and other third-party vendors as well as the timely processing of any change orders from the contract research organizations. Revenue Recognition The Company’s revenue generally consists of research related revenue under federal contracts, supply revenue and licensing revenue related to non-refundable upfront fees, milestone payments and royalties earned under license agreements. Revenue is recognized when the following criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery of the products and/or services has occurred; (3) the selling price is fixed or determinable; and (4) collectability is reasonably assured. For arrangements that involve the delivery of more than one element, each product, service and/or right to use assets is evaluated to determine whether it qualifies as a separate unit of accounting. This determination is based on whether the deliverable has “stand-alone value” to the customer. The consideration that is fixed or determinable is then allocated to each separate unit of accounting based on the relative selling prices of each deliverable. The consideration allocated to each unit of accounting is recognized as the related goods and services are delivered, limited to the consideration that is not contingent upon future deliverables. When an arrangement is accounted for as a single unit of accounting, the Company determines the period over which the performance obligations will be performed and revenue recognized. Milestone payments are recognized when earned, provided that (i) the milestone event is substantive; (ii) there is no ongoing performance obligation related to the achievement of the milestone earned; and (iii) it would result in additional payments. Milestone payments are considered substantive if all of the following conditions are met: the milestone payment is non-refundable; achievement of the milestone was not reasonably assured at the inception of the arrangement; substantive effort is involved to achieve the milestone; and the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement, and the related risk associated with the achievement of the milestone. Contingent-based payments the Company may receive under a license agreement will be recognized when received. Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of common stock shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common stock shares adjusted for the dilutive effect of common stock equivalent shares outstanding during the period. Common stock equivalents consist of convertible senior notes (using the “as if converted” method), stock options, restricted stock shares and stock warrants. Common equivalent shares are excluded from the computation in periods in which they have an anti-dilutive effect on earnings per share. Share-Based Compensation The Company accounts for share-based compensation following the provisions of FASB ASC Topic 718, Stock Compensation The Company recorded the following share-based compensation expense in accordance with ASC Topic 718 (in thousands): Year Ended December 31, 2016 2015 2014 Research and development $ 2,942 $ 1,948 $ 811 General and administrative 11,381 3,940 2,294 Total $ 14,323 $ 5,888 $ 3,105 Allocations to research and development and general and administrative expense are based upon the department to which the associated employee reported. No related tax benefits of the share-based compensation expense have been recognized. Valuation Assumptions for Stock Option Plans The employee share-based compensation expense recognized was determined using the Black-Scholes option-pricing model. Option-pricing models require the input of subjective assumptions and these assumptions can vary over time. The weighted-average assumptions used to determine the fair value of each option grant are as follows: 2016 2015 2014 Estimated dividend yield 0.0 % 0.0 % 0.0 % Expected share price volatility 76.7 % 74.3 % 82.3 % Risk-free interest rate 1.6 % 1.7 % 2.0 % Expected life of option (in years) 5.5 5.6 5.8 Weighted-average fair value per share $ 15.55 $ 17.00 $ 8.58 Expected stock price volatility is based on an average of the Company’s volatility and several peer public companies due to the Company’s limited history. For purposes of identifying peer companies, the Company considered characteristics such as industry, market capitalization, length of trading history, similar vesting terms and in-the-money option status. The risk-free rate is based on the U.S. Treasury yield curve during the expected life of the option. The dividend yield percentage is zero because the Company neither currently pays dividends nor intends to do so during the expected option term. The expected term represents the average time that options are expected to be outstanding. Due to a lack of term length data, the Company elected to use the mid-point between the vesting date and the contractual term as the expected term for employee options and contractual life for non-employees options. This is in accordance with the simplified method prescribed in SEC Staff Accounting Bulletin No. 107, Share-Based Payment Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers. This new guidance clarifies the principles for recognizing revenue and develops a common revenue standard for U.S. GAAP. The guidance outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes the most current revenue recognition guidance. This guidance, as amended by ASU 2015-14, is effective for fiscal years and interim periods within those years beginning after December 15, 2017, which is effective for the Company for the year ending December 31, 2018. In March 2016, the FASB issued ASU 2016-08, Revenue from Contracts with Customers: Principal versus Agent Considerations, which clarifies the implementation guidance on principal versus agent considerations. In April 2016, the FASB issued ASU 2016-10, Revenue from Contracts with Customers: Identifying Performance Obligations and Licensing, which clarifies an entity’s identification of its performance obligations in a contract. The update also clarifies the guidance regarding an entity’s evaluation of the nature of its promise to grant a license of intellectual property and whether or not that revenue is recognized over time or at a point in time. In May 2016, the FASB issued ASU 2016-12, Revenue from Contracts with Customers: Narrow-Scope Improvements and Practical Expedients, which amends the guidance in the new revenue standard on collectability, non-cash consideration, presentation of sales tax, and transition. In December 2016, the FASB issued ASU 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers which increases shareholders’ awareness of the proposals and expedites improvements to Update 2014-09. The amendments are intended to address implementation issues that were raised by stakeholders and provide additional practical expedients to reduce the cost and complexity of applying the new revenue standard. These pronouncements have the same effective date as the new revenue standard. In December 2016, the Company received a Complete Response Letter (“CRL”) from the FDA which outlined a number of steps the Company would be required to complete prior to commercial approval of solithromycin. Based on the nature of the items outlined in the CRL, the launch of solithromycin for the treatment of community acquired bacterial pneumonia, has been delayed. As a result, the Company has determined that it will not early adopt the new revenue recognition guidance in 2017. The Company has evaluated the contract research agreement with BARDA, and does not anticipate a material impact on the financial statements. The Company is currently evaluating the license agreement with Toyama to determine the impact that the implementation of this standard will have on the financial statements, if any. The Company plans to use the full retrospective method of adoption effective January 1, 2018. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements-Going Concern. The guidance addresses management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. The Company has adopted this guidance as of December 31, 2016. In February 2016, the FASB issued ASU 2016-02, Leases. The new guidance will increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. This guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. The Company is currently evaluating the impact that the implementation of this standard will have on the Company’s consolidated financial statements. In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation. The new guidance simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. This guidance is effective for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements. In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments. ASU 2016-15 will make eight targeted changes to how cash receipts and cash payments are presented and classified in the statement of cash flows. This new guidance is effective for fiscal years beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements. In January 2017, the FASB issued ASU 2017-01, Business Combinations: Clarifying the Definition of a Business which revises the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. This new guidance is effective for fiscal years beginning after December 15, 2017. The Company is currently evaluating the impact that the implementation of this standard will have on the Company’s consolidated financial statements. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments The carrying values of cash equivalents, receivables, prepaid expenses, and accounts payable at December 31, 2016 approximated their fair values due to the short-term nature of these items. The Company’s valuation of financial instruments is based on a three-tiered approach, which requires that fair value measurements be classified and disclosed in one of three tiers. These tiers are: Level 1, defined as quoted prices in active markets for identical assets or liabilities; Level 2, defined as valuations based on observable inputs other than those included in Level 1, such as quoted prices for similar assets and liabilities in active markets, or other inputs that are observable or can be corroborated by observable input data; and Level 3, defined as valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants. At December 31, 2016 and December 31, 2015, the Company held money market funds classified as Level 1 financial instruments of $228.5 |
Significant Agreements and Cont
Significant Agreements and Contracts | 12 Months Ended |
Dec. 31, 2016 | |
Significant Agreements And Contracts [Abstract] | |
Significant Agreements and Contracts | 4. Significant Agreements and Contracts License Agreements Optimer Pharmaceuticals, Inc. In March 2006, the Company, through its wholly owned subsidiary, Cempra Pharmaceuticals, Inc., entered into a Collaborative Research and Development and License Agreement (“Optimer Agreement”) with Optimer Pharmaceuticals, Inc. (“Optimer”) which was acquired by Cubist Pharmaceuticals, Inc. in October 2013, which was in turn acquired by Merck in January 2015. Under the terms of the Optimer Agreement, the Company acquired exclusive rights to further develop and commercialize certain Optimer technology worldwide, excluding member nations of the Association of Southeast Asian Nations. In exchange for this license, during 2006 and 2007, the Company issued an aggregate of 125,646 common shares with a total fair value of $0.2 million to Optimer. These issuances to Optimer were expensed as incurred in research and development expense. In July 2010, the Company paid a $0.5 million milestone payment to Optimer after the successful completion of its first solithromycin Phase 1 program. In July 2012, the Company paid a $1.0 million milestone payment after the successful completion of its first solithromycin Phase 2 program. Both milestones were expensed as incurred in research and development expense. Under the terms of the Optimer Agreement, the Company will owe Optimer additional payments, contingent upon the achievement of various development, regulatory and commercialization milestone events. One such milestone event would be owed upon FDA approval of solithromycin which would result in a payment to Optimer of $9.5 million. The aggregate amount of such milestone payments the Company may need to pay is based in part on the number of products developed under the agreement and would total $27.5 million (including the two milestone payments made to date and the milestone payment for FDA approval) if four products are developed and gain FDA approval. The Company will also pay tiered mid-single-digit royalties based on the amount of annual net sales of its approved products. The Scripps Research Institute In June 2012, the Company entered into a license agreement with The Scripps Research Institute (“TSRI”), whereby TSRI licensed to the Company rights, with rights of sublicense, to make, use, sell, and import products for human or animal therapeutic use that use or incorporate one or more macrolides as an active pharmaceutical ingredient and is covered by certain patent rights owned by TSRI claiming technology related to copper-catalysed ligation of azides and acetylenes. The rights licensed to the Company are exclusive as to the People’s Republic of China (excluding Hong Kong), South Korea and Australia, and are non-exclusive in all other countries worldwide, except the member-nations of the Association of Southeast Asian Nations, which are not included in the territory of the license. Under the terms of the agreement with TSRI, the Company paid a one-time only, non-refundable license issue fee in the amount of $0.4 million which was charged to research and development expense in the second quarter of 2012. The Company is also obligated to pay annual maintenance fees to TSRI in the amount of (i) $50,000 each year for the first three years (beginning on the first anniversary of the agreement), and (ii) $85,000 each year thereafter (beginning on the fourth anniversary of the agreement). Each calendar year’s annual maintenance fees will be credited against sales royalties due under the agreement for such calendar year. Under the terms of the agreement, the Company must pay TSRI low single-digit percentage royalties on the net sales of the products covered by the TSRI patents for the life of the TSRI patents, a low single-digit percentage of non-royalty sublicensing revenue received with respect to countries in the nonexclusive territory and a mid-single-digit percentage of sublicensing revenue received with respect to countries in the exclusive territory, with the sublicensing revenue royalty in the exclusive territory and the sales royalties subject to certain reductions under certain circumstances. TSRI is eligible to receive milestone payments of up to $1.1 million with respect to regulatory approval in the exclusive territory and first commercial sale, in each of the exclusive territory and nonexclusive territory, of the first licensed product to achieve those milestones that is based upon each macrolide covered by the licensed patents. Each milestone is payable once per each macrolide. Each milestone payment made to TSRI with respect to a particular milestone will be creditable against any payment due to TSRI with respect to any sublicense revenues received in connection with the achievement of such milestone. Pursuant to the terms of the Optimer Agreement, any payments made to TSRI under this license for territories subject to the Optimer Agreement can be deducted from any sales-based royalty payments due under the Optimer Agreement up to a certain percentage reduction of the royalties due to Optimer. Under the terms of the agreement, the Company is also required to pay additional fees on royalties, sublicensing and milestone payments if the Company, an affiliate with TSRI, or a sublicensee challenges the validity or enforceability of any of the patents licensed under the agreement. Such increased payments would be required until all patent claims subject to challenge are invalidated in the particular country where such challenge was mounted. In December 2014, the Company paid a $0.2 million milestone payment to TSRI in relation to license and milestone payments received under the license agreement with Toyama (discussed below). The term of the license agreement (and the period during which the Company must pay royalties to TSRI in a particular country for a particular product) will end, on a country-by-country and product-by-product basis, at such time as no patent rights licensed from TSRI cover a particular product in the particular country. TSRI may terminate the agreement in the event (i) the Company fails to cure any non-payment or default on its indemnity or insurance obligations, (ii) the Company declares insolvency or bankruptcy, (iii) the Company is convicted of a felony relating to the development, manufacture, use, marketing, distribution or sale of any products licensed under the agreement, (iv) the Company fails to cure any underreporting or underpayment by a certain amount in any 12-month period, or (v) the Company fails to cure any default on any other obligation under the agreement. The Company may terminate the agreement with or without cause upon written notice. In the event of such termination, (i) all licenses granted to the Company will terminate except in the case of any sublicensee that was not the cause of the termination, is not in default on its obligations under its sublicense, and that pays any unpaid amounts owed by the Company under the agreement with respect to the sublicense, and (ii) the Company may complete any work in progress and sell any completed inventory on hand for a period of time after termination. Biomedical Advanced Research and Development Authority In May 2013, the Company entered into an agreement with BARDA, for the evaluation and development of the Company’s lead product candidate solithromycin for the treatment of bacterial infections in pediatric populations and infections caused by bioterror threat pathogens. The agreement is a cost plus fixed fee development contract, with a base performance segment valued at approximately $18.7 million with contract modifications, and four option work segments that BARDA may request at its sole discretion pursuant to the agreement. If all four option segments are requested, the cumulative value of the agreement, as amended to date, would be approximately $68.2 million and the estimated period of performance would be until approximately May 2018 The period of performance for the base performance segment was May 2013 through February 2016. BARDA exercised the second option in November 2014. The value of the second option work segment is approximately $16.0 million and the estimated period of performance is November 2014 through April 2017. In February 2016, BARDA exercised the third option work segment of the agreement which is intended to fund a Phase 2/3 study of intravenous, oral capsule and oral suspension formulations of solithromycin in pediatric patients from newborn to 17 years with community acquired bacterial pneumonia. This option work segment is a cost-sharing arrangement under which BARDA will contribute $25.5 million and the Company will be responsible for an additional designated portion of the costs associated with the work segment. In September 2016, the contract was modified to increase the third option work segment by $8.0 million for increased manufacturing work related to the development of a second supply source for solithromycin. The amendment raises the value of the third option work segment to approximately $33.5 million. The estimated period of performance of this option work segment runs through May 2018. Under the agreement, the Company is reimbursed and recognizes revenue as allowable costs are incurred plus a portion of the fixed-fee earned. The Company considers fixed-fees under cost reimbursable agreements to be earned in proportion to the allowable costs incurred in performance of the work as compared to total estimated agreement costs, with such costs incurred representing a reasonable measurement of the proportional performance of the work completed. For the years ended December 31, 2016, 2015 and 2014, the Company recognized $13.7, $12.4 and $9.6 The agreement provides the U.S. government the ability to terminate the agreement for convenience or to terminate for default if the Company fails to meet its obligations as set forth in the statement of work. The Company believes that if the government were to terminate the agreement for convenience, the costs incurred through the effective date of such termination and any settlement costs resulting from such termination would be allowable costs. Toyama Chemical Co., Ltd. In May 2013, Cempra Pharmaceuticals, Inc., the Company’s wholly owned subsidiary, entered into a license agreement with Toyama Chemical Co., Ltd. (“Toyama”), whereby the Company licensed to Toyama the exclusive right, with the right to sublicense, to make, use and sell any product in Japan that incorporates solithromycin, the Company’s lead compound, as its sole active pharmaceutical ingredient, or API, for human therapeutic uses, other than for ophthalmic indications or any condition, disease or affliction of the ophthalmic tissues. Toyama also has a nonexclusive license in Japan and certain other countries, with the right to sublicense, to manufacture or have manufactured API for solithromycin for use in manufacturing such products, subject to limitations and obligations of the concurrently executed supply agreement discussed below. Toyama granted the Company certain rights to intellectual property generated by Toyama under the license agreement with respect to solithromycin or licensed products for use with such products outside Japan or with other solithromycin-based products inside or outside Japan. Following execution of the agreement, the Company received a $10.0 $60.0 In August 2014, the Company received a $10.0 million milestone payment from Toyama (“August 2014 Milestone”), which was triggered by Toyama’s progress of its solithromycin clinical development program in Japan. The payment was made following Toyama’s receipt of regulatory clearance to begin a Phase 2 trial of solithromycin in Japan following successful completion of a Phase 1 trial. In October 2016, the Company received the third $10.0 million milestone from Toyama (“October 2016 Milestone”), which was triggered by Toyama’s progress of solithromycin clinical development program in Japan. As part of the license agreement, Toyama and the Company also entered into a supply agreement, whereby the Company will be the exclusive supplier (with certain limitations) to Toyama and its sublicensees of API for solithromycin for use in licensed products in Japan, as well as the exclusive supplier to Toyama and its sublicensees of finished forms of solithromycin to be used in Phase 1 and Phase 2 clinical trials in Japan. Pursuant to the supply agreement, which is an exhibit to the license agreement, Toyama will pay the Company for such clinical supply of finished product and all supplies of API for solithromycin for any purpose, other than the manufacture of products for commercial sale in Japan, at prices equal to the Company’s cost . The Company has determined that there are six deliverables under this agreement including (1) the license to develop and commercialize solithromycin in Japan, (2) the obligation of the Company to conduct Phase 3 studies and obtain regulatory approval in the United States and one other territory, (3) participation in a Joint Development Committee, or JDC, (4) participation in a Joint Commercialization Committee, or JCC, (5) the right to use the Company’s trademark, and (6) a supply agreement. The amounts received under the license agreement have been allocated to the deliverables based on their relative fair values and will be recognized into income when the revenue recognition criteria have been achieved. Milestone payments are recognized when earned, provided that (i) the milestone event is substantive; (ii) there is no ongoing performance obligation related to the achievement of the milestone earned; and (iii) it would result in additional payments. Milestone payments are considered substantive if all of the following conditions are met: the milestone payment is non-refundable; achievement of the milestone was not reasonably assured at the inception of the arrangement; substantive effort is involved to achieve the milestone; and the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement, and the related risk associated with the achievement of the milestone. Contingent-based payments the Company may receive under a license agreement will be recognized when received. Royalties are recorded as earned in accordance with the contract terms when third party sales can be reliably measured and collectability is reasonably assured. The Company recognized $4.3 million in revenue associated with the delivery of the license in May 2013. Additionally, because the milestone event triggering the August 2014 Milestone and October 2016 Milestone payments were considered non-substantive for accounting purposes, these milestone payments are being recognized into revenue proportionately to the six deliverables in the agreement using the same allocation as the upfront payment. Therefore, $4.3 million of the August 2014 Milestone payment was recognized into revenue in August 2014 and $4.3 million of the October 2016 Milestone payment was recognized into revenue in October 2016. The remainder of the upfront and milestone payments which aggregate to $17.0 million are recorded as deferred revenue at December 31, 2016 and will be recognized as revenue when the revenue recognition criteria of each deliverable has been met. The Company also recognized a $10.0 million milestone based on the Japan Patent Office issuing a Decision of Allowance for the Company’s patent covering certain crystal forms of solithromycin in Japan. The March 2015 milestone payment is considered substantive for accounting purposes, and therefore the $10.0 million milestone was recognized in its entirety as revenue in March 2015. FUJIFILM Finechemicals Co., Ltd . On January 18, 2016, Cempra Pharmaceuticals, Inc. entered into an API manufacturing and supply agreement with FUJIFILM Finechemicals Co., Ltd. (“FFFC”), which will provide the Company with solithromycin in sufficient quantities and at reasonable prices to help ensure it meets its obligation under the May 8, 2013 supply agreement with Toyama. The Company will use reasonable efforts to ensure that the solithromycin supplied by FFFC is for use as the active pharmaceutical ingredient in a human drug product to be used or sold in Japan. The Company is subject to a minimum purchase obligation for a designated number of years after the successful completion of the manufacturing facility and validation studies by FFFC. Each calendar month, the Company will submit to FFFC a projection of the anticipated volume of solithromycin that it will order for the next designated period (as set forth in the agreement) (or, if earlier, the final calendar month of the current term). Several months of each forecast are binding and the remaining months are non-binding, provided that the quantity of solithromycin ordered for any month is between designated percentages of the quantity specified in the initial forecast and between designated percentages of the most recent previous forecast. The price of each shipment of solithromycin will be equal to the total number of kilograms in such shipment multiplied by the per-kilogram transfer price as set forth in the agreement. For the term of the agreement plus an additional five years or until the expiration of the patents identified in the agreement, FFFC is prohibited from supplying, selling or distributing solithromycin to, or enabling the manufacture of solithromycin by, any third party for any purpose. The Company is not precluded from developing one or more alternative or additional sources of solithromycin. The agreement’s initial term runs until December 16, 2025. After the end of the initial term, and at the end of each year thereafter, the term will automatically extend for an additional year unless either party gives written notice to the other of its intent to terminate within a designated period of time prior to the expiration of the term, in which case the agreement will terminate at the end of such term. The parties may at any time terminate the agreement by mutual written consent. Each party has the right to terminate the agreement immediately if there is a product failure, the other party becomes involved in bankruptcy, insolvency or similar proceedings or materially breaches the agreement and such breach remains uncured for a period of time following notice of the breach. A violation by the Company of the minimum purchase obligation is considered a material breach. A product failure is not considered a material breach by the Company. The Company has the right to terminate the agreement upon written notice if there is a supply failure. The Company also may terminate in the event that FFFC cannot provide the Company with solithromycin for more than a designated period of time. Upon termination, any unfulfilled binding portion of the forecast must be delivered by FFFC and paid for by the Company. The Company also may elect to purchase the remaining inventory of FFFC’s solithromycin and any remaining raw materials. If FFFC terminates the agreement for a material breach by the Company and, prior to such termination, (i) FFFC has constructed a facility in Japan for the primary purpose of manufacturing API for the Company under the agreement and (ii) such facility is completed and fully operational and qualified for the manufacture of API for delivery thereunder, then, except to the extent otherwise agreed to by the parties, the Company will pay FFFC an amount equal to (a) the remaining book value of the facility less (b) the product of the number of kilograms of API ordered by the Company under the agreement prior to such termination times a designated dollar amount, provided that if the total direct costs incurred by FFFC in the construction of the facility, net of any tax credits, tax refunds, government subsidies, or similar financial, monetary, or in-kind benefits provided by any governmental agency or authority, do not equal or exceed a designated dollar amount, then the remaining book value will be reduced by a pro rata amount, based on ratios set forth in the agreement, and (z) no amount will be payable if the agreement terminates after December 31, 2025; provided, however, that if FFFC manufactures any product or performs any activities (other than the manufacture of API for the Company under the agreement) in, by, or using the facility prior to such termination and makes any profit thereby, the total amount of such profits will be subtracted from the total payment amount due from the Company to FFFC. Macrolide Pharmaceuticals, Inc. On January 29, 2016, Cempra Pharmaceuticals, Inc. entered into an Option and License Agreement with Macrolide Pharmaceuticals, Inc. (“MP”), pursuant to which MP granted the Company an exclusive option to license certain of MP’s patents and know-how involving macrolides, including specifically novel methods of synthesizing solithromycin (the “Compound”). Under the agreement, the Company will support research at MP focused on developing a novel, cost-competitive manufacturing approach to solithromycin. The option will run until the later to occur of (i) the earlier of (a) the date that the Company first obtains FDA approval for any product incorporating the Compound as an API, or (b) January 27, 2019, or (ii) the date that is six months after the earlier of (a) MP’s satisfaction of certain milestones, or (b) the Company’s termination of MP’s obligations under the evaluation program. Under the evaluation program called for in the agreement, MP will conduct research activities for the manufacture of the Compound, which activities the Company will evaluate to determine whether to exercise the option to license. Upon execution of the agreement, the Company paid MP a non-refundable, non-creditable initial license fee of $0.4 million. For conducting the evaluation program, the Company paid MP a non-refundable, non-creditable fee in the amount of $0.4 million. In addition, the Company will pay MP the expected reasonable, documented, direct compensation-related costs of employees and advisors necessary to conduct MP’s portion of the evaluation program in the aggregate amount of $1.5 million, which the Company will pay in 18 equal consecutive non-refundable, non-creditable monthly installments of $83,333, beginning with the first monthly anniversary of entry into the agreement. Further, the Company will pay MP up to an aggregate of $1.0 million upon the satisfaction of certain performance milestones. If the Company exercises the option, the license will be exclusive and worldwide (other than Association of Southeast Asian Nations) and for any and all uses in human and non-human animals, and with the right to sublicense. The Company may, in its discretion, exercise the option for a reduced portion of the territory and, if the Company makes this election, may increase as it wishes within the territory, and as many times as it wishes, provided such increase is made within 60 months of the Company’s exercise of the option. If the Company exercises the option, it will pay MP a non-refundable, non-creditable license fee of $1.0 million, of which $0.5 million will be paid within 15 business days of exercise, and $0.5 million will be paid in the form of “deemed royalty” payments (up to such amount) equal to a fraction of a percent of net sales of licensed products. The Company will pay tiered royalties of a fraction of a percent on designated levels of annual net sales of license products. Further, the Company will pay a non-refundable, non-creditable additional royalty equal to a fraction of a percent on the net sales of licensed products of a designated amount sold by the Company, its sublicensees, and product partners, but the royalty will not exceed $1.0 million in the aggregate. Royalties will be paid on a country-by-country basis and product-by-product basis until the date on which there are no valid claims of any licensed MP patent covering a product in the applicable country. If the Company exercises the option, the agreement’s term will run on a country by country and product by product basis until the date on which there are no valid claims in the licensed MP patents covering a particular product in a particular country. |
Receivables
Receivables | 12 Months Ended |
Dec. 31, 2016 | |
Receivables [Abstract] | |
Receivables | 5. Receivables Receivables consist of amounts billed and amounts earned but unbilled under the Company’s licensing agreements or its contract with BARDA. At December 31, 2016, the Company’s receivables consisted primarily of earned but unbilled receivables under the BARDA agreement. At December 31, 2015, the Company’s receivable consisted primarily of earned but unbilled receivables under the BARDA agreement and API purchases made for Toyama’s clinical development of solithromycin in Japan. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2016 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 6. Accrued Expenses Accrued expenses are comprised of the following as of (in thousands): December 31, 2016 2015 Accrued severance $ 1,999 $ - Franchise tax 570 436 Accrued professional fees 145 642 Deferred rent 85 76 Accrued interest 80 99 Other accrued expenses 50 222 Total accrued expenses $ 2,929 $ 1,475 |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 7. Long-term Debt In July 2015, the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with Comerica Bank (“Comerica). The Loan and Security Agreement provides that the Company may borrow up to $20.0 million in a term loan (the “Term Loan”) and, upon FDA approval of its planned New Drug Application for solithromycin, the Company may also borrow an aggregate amount equal to the lesser of (i) up to 75% of its eligible inventory and 80% of eligible accounts receivable or (ii) $10.0 million (the “Revolver”). After FDA approval of the Company’s planned New Drug Application for solithromycin, the Company may convert the Term Loan to the Revolver, in which event the Revolver would have a maximum amount available to the Company of $25.0 million. The Loan and Security Agreement specifies the criteria for determining eligible inventory and eligible accounts receivable and sets forth ongoing limitations and conditions precedent to the Company’s ability to borrow under the Revolver. The Company granted Comerica a security interest in substantially all of its personal property assets, excluding its intellectual property and its stock in its subsidiaries, to secure its outstanding obligations under the Loan and Security Agreement. The Company is also obligated to comply with various other customary covenants, including, among other things, restrictions on its ability to: dispose of assets, make acquisitions, be acquired, incur indebtedness, grant liens, make distributions to its stockholders, make investments, enter into certain transactions with affiliates, or pay down subordinated debt, subject to specified exceptions. At closing, the Company received the full $20.0 million under the Term Loan and paid a facility fee of $0.1 million for the Term Loan and a facility fee of $0.2 million for the Revolver. The Company immediately used proceeds from the Term Loan to pay all of its $17.7 million outstanding principal and interest and $1.2 million in end of term and prepayment fees under the loan and security agreement (“December 2011 Note”) with Hercules Technology Growth Capital, Inc. (“Hercules”) and terminated the Hercules loan. The Company recorded a charge of $0.3 million on the early extinguishment of the December 2011 Note. Amounts borrowed under the Term Loan may be repaid and reborrowed at any time without penalty or premium. The Term Loan is interest-only through April 30, 2016, followed by an amortization period of 36 months of equal monthly payments of principal plus interest, beginning on May 1, 2016 and continuing on the same day of each month thereafter until paid in full. Any amounts borrowed under the Term Loan bear interest at a floating interest rate equal to the 30 Day LIBOR rate plus 5.2%. Amounts available to be borrowed under the Revolver may also be repaid and reborrowed at any time without penalty or premium prior to December 31, 2017, at which time all advances under the Revolver shall be immediately due and payable in full. Any amounts borrowed under the Revolver will bear interest at the 30 Day LIBOR rate plus 4.2. Once available, the Revolver is subject to an annual unused facility fee equal of 0.25%. Under the Loan and Security Agreement, the Company is subject to certain covenants including maintaining a minimum unrestricted cash balance of $15.0 million and continuing the development or commercially launching solithromycin. In December 2011, the Company entered into the $20.0 million December 2011 Note with Hercules and borrowed $10.0 million upon closing. Borrowings under the December 2011 Note bore interest at the greater of (i) 9.55%, or (ii) the sum of 9.55% plus the prime lending rate, as published by the Wall Street Journal, minus 3.25% per annum. In connection with the initial closing of the December 2011 Note, the Company entered into a warrant agreement with Hercules. In May 2013, the Company amended its December 2011 Note, increasing the initial loan amount to $15.0 million, and receiving an additional $5.2 million upon closing. In March 2014, the Company amended the December 2011 Note providing the Company the ability to request, at any time prior to December 26, 2014, another borrowing in the aggregate amount of $3.0 million. This amendment also provided for the Company to make interest only payments through May 31, 2015. In June 2014, the Company borrowed the additional $3.0 million and amended the December 2011 Note to provide the Company the ability to borrow up to an additional $10.0 million. Warrants associated with the December 2011 Note were reclassified to additional paid-in capital in the second quarter of 2014. The Hercules loan was terminated and paid using proceeds from the Comerica Term Loan. In connection with the initial closing of the December 2011 Note, the Company entered into a warrant agreement with Hercules (the “First Hercules Warrant”), under which Hercules has the right to purchase 39,038 shares of the Company’s common stock. The exercise price of the First Hercules Warrant was initially $10.25 per share, subject to adjustment in the event of a merger, reclassification, subdivision or combination of shares or stock dividend and subject also to antidilution protection. In connection with the May 2013 amendment to the loan agreement, the exercise price of the First Hercules Warrant was reduced to the lower of (a) $6.11, and (b) the effective price per share of the Company’s common stock issued or issuable in any offering of the Company’s equity or equity-linked securities that occurred prior to June 1, 2014, provided that such offering was effected principally for equity or debt-financing purposes. Since the May 2013 amendment to the warrant resulted in a variable exercise price, the fair value of the warrant as of the date of the amendment was reclassified from additional paid-in capital to a warrant liability. The Company did not offer any common stock between the amendment date and June 1, 2014 at a price below $6.11, therefore, the exercise price of the First Hercules Warrant became fixed at $6.11, which resulted in the warrant liability being reclassified to additional paid-in capital in the second quarter of 2014. Additionally, in connection with the May 2013 amendment of the December 2011 Note, the Company entered into a warrant agreement with Hercules (the “Second Hercules Warrant”), under which Hercules has the right to purchase an aggregate number of shares of the Company’s common stock equal to the quotient derived by dividing $0.6 million by the exercise price then in effect, which is defined as the lower of (a) $6.11, and (b) the effective price per share of the Company’s common stock issued or issuable in any offering of the Company’s equity or equity-linked securities prior to June 1, 2014, provided that such offering was effected principally for equity or debt-financing purposes. The Second Hercules Warrant expires on May 31, 2023. Proceeds equal to the fair value of the Second Hercules Warrant were recorded as a liability at the date of issuance. The Company did not offer any common stock between the amendment date and June 1, 2014 at a price below $6.11, therefore, the exercise price of the Second Hercules Warrant became fixed at $6.11, which resulted in the warrant being fixed at 99,759 shares of common stock and the warrant liability being reclassified to additional paid-in capital in the second quarter of 2014. In December 2014, Hercules exercised the First Hercules Warrant of 39,038 shares and the Second Hercules Warrant of 99,759 shares in a cashless exercise which resulted in 97,931 shares issued. The exercise price was deemed to be $20.75, the average of the closing prices over a five-day period ending three days before the day the current fair market value of the common stock was determined. Scheduled Maturities: Scheduled maturities of long-term debt are as follows (in thousands): Year Ending December 31: 2017 6,667 2018 6,667 2019 2,222 Total 15,556 Less: Unamortized discount (229 ) Less: Current portion of long-term debt (6,667 ) Long-term debt $ 8,660 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies Future minimum lease payments required under non-cancellable operating leases as of December 31, 2016 are as follows (in thousands): Operating Leases 2017 $ 744 2018 762 2019 503 2020 308 2021 and thereafter 42 Total minimum lease payments $ 2,359 Rent expense for the years ended December 31, 2016, 2015 and 2014 was $0.7 million, $0.4 million, and $0.2 million, respectively. See Note 4—Significant Agreements and Contracts for contingencies related to the Optimer Agreement and the TSRI agreement. Legal Proceedings On November 4, 2016, a securities class action lawsuit was commenced in the United States District Court, Middle District of North Carolina, Durham Division, naming the Company and certain of the Company’s officers as defendants, and alleging violations of the Securities Exchange Act of 1934 in connection with allegedly false and misleading statements made by the defendants between May 1, 2016 and November 1, 2016 (the “Class Period”). The plaintiff seeks to represent a class comprised of purchasers of the Company’s common stock during the Class Period and seeks damages, costs and expenses and such other relief as determined by the Court. Two substantially similar lawsuits were filed in the United States District Court, Middle District of North Carolina on November 22, 2016 and December 30, 2016, respectively. The Company believes it has meritorious defenses and intends to defend the lawsuits vigorously. It is possible that similar lawsuits may yet be filed in the same or other courts that name the same or additional defendants. On December 21, 2016, a shareholder derivative lawsuit was commenced in the North Carolina Durham County Superior Court, naming certain of the Company’s former and current officers and directors as defendants and the Company as a nominal defendant, and asserting claims for breach of fiduciary duty, unjust enrichment, abuse of control, gross mismanagement, and corporate waste. A substantially similar lawsuit was filed in the North Carolina Durham County Superior Court on February 16, 2017. The complaints are based on similar allegations as asserted in the securities lawsuits described above, and seeks unspecified damages and attorneys' fees. The Company believes it has meritorious defenses and intends to defend the lawsuits vigorously. It is possible that similar lawsuits may yet be filed in the same or other courts that name the same or additional defendants. Other than as described above, the Company is not a party to any legal proceedings and is not aware of any claims or actions pending or threatened against the Company. In the future, the Company might from time to time become involved in litigation relating to claims arising from its ordinary course of business. Accrued Severance In December 2016, the Company entered into a Retirement and Consulting Agreement with then current CEO, Dr. Prabhavathi Fernandes, whereby, for one year, subject to monthly extensions by mutual agreement, she will provide consulting services to the Company for up to 20 hours per week. For her consulting work, the Company will pay Dr. Fernandes $35,000 per month. In addition, all of Dr. Fernandes’s stock options will continue to vest during the consulting period. The Company recognized $4.2 million of accelerated stock compensation expense in the fourth quarter of 2016 due to the change in employment status from CEO to a consultant with continued service. Additionally, Dr. Fernandes is entitled to the severance payments and benefits described in her employment agreement. In consideration of her waiver of the notice period provided under her employment agreement, the Company will pay Dr. Fernandes $45,000. In lieu of her pro-rated annual bonus due under her employment agreement upon a termination of employment, the Company will pay Dr. Fernandes an annual bonus for 2016 in the amount of $280,260. From the effective date of the release, the Company will continue to pay Dr. Fernandes her base salary for 18 months, at the current annual rate of $540,000. In addition, the Company will pay Dr. Fernandes an amount equal to one and one half times her Target Bonus (as defined in her employment agreement), based upon the average percentage of achievement of target objectives for the prior three years, which amount is $420,390, payable in 18 equal monthly payments. From the effective date of the release, upon the conclusion of the consulting period, or upon an earlier change in control of the Company, all of Dr. Fernandes’s then outstanding and unvested stock options will become fully vested. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Shareholders' Equity | 9. Shareholders’ Equity Common Stock In May 2016, the Company entered into an at-the-market (“ATM”) sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”) under which the Company may, at its discretion, from time to time sell shares of its common stock, with a sales value of up to $150.0 million. The Company has provided Cowen with customary indemnification rights, and Cowen is entitled to a commission at a fixed commission rate of 3.0% of the gross proceeds per share sold. Sales of the shares under the Sales Agreement are to be made in transactions deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. The Company began the sale of ATM shares in May 2016. Through December 31, 2016, the Company sold 4,140,307 shares of common stock under the Sales Agreement resulting in net proceeds of $75.1 million after deducting commissions and expenses of $2.3 million. During January 2016, the Company completed a public offering of 4,166,667 shares of common stock, at a price of $24.00 per share, resulting in net proceeds to the Company of approximately $93.8 million after deducting underwriting discounts and expenses of approximately $6.2 million. During 2016, the Company issued 95,180 shares of common stock at a weighted average exercise price of $5.17 per share upon the exercise of option grants. During January 2015, the Company completed a public offering issuing 6,037,500 shares of common stock, at a price of $24.50 per share, resulting in net proceeds to the Company of approximately $138.8 million after deducting underwriting discounts and commissions, and expenses of approximately $9.1 million During 2015, the Company issued 417,999 shares of common stock at a weighted average exercise price of $6.40 per share for the exercise of option grants and 60,309 shares of common stock at a weighted average exercise price of $6.00 per share for the exercise of warrants issued. In March 2013, the Company entered into an at-the-market (“ATM”) sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”) under which the Company could, at its discretion, from time to time sell shares of its common stock, with a sales value of up to $25.0 million. The Company provided Cowen with customary indemnification rights, and Cowen was entitled to a commission at a fixed commission rate of 3.0% of the gross proceeds per share sold. Sales of the shares under the Sales Agreement were to be made in transactions deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. In October 2014, the Company and Cowen amended the Sales Agreement (the “Amended Agreement”) to increase the aggregate gross sales proceeds that could be raised to $50 million. The Company began the sale of ATM shares in July 2014 and sold an aggregate of 4,092,525 shares of common stock under the Sales Agreement in 2014 resulting in net proceeds of $48.5 million after deducting commissions of $1.5 million. The Sales Agreement was terminated on January 5, 2015. The following table presents common stock reserved for future issuance for the following equity instruments as of December 31, 2016: Warrants to purchase common stock (1) 94,912 Options and restricted stock units: Outstanding under the 2006 Stock Plan 451,525 Outstanding under the 2011 Equity Incentive Plan 3,382,821 Available for future grants under the 2011 Equity Incentive Plan 2,900,230 Total common stock reserved for future issuance 6,829,488 (1) The Warrants to purchase common stock are exercisable at a price of $6.00 per share and expire in August 2018. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | 10. Share-Based Compensation The Company adopted the 2006 Stock Plan in January 2006 (“the 2006 Plan”). The 2006 Plan provided for the granting of incentive share options, nonqualified share options and restricted shares to Company employees, representatives and consultants. As of December 31, 2016, there were options for an aggregate of 451,525 shares issued and outstanding under the 2006 Plan. The Company’s board of directors adopted the 2011 Equity Incentive Plan in October 2011 (the “2011 Plan”), which, as amended in May 2015, authorizes the issuance of up to 6,601,735 shares under the 2011 Plan, with an automatic annual increase discussed below. As of December 31, 2016, there were 2,900,230 options shares available under the 2011 Plan. The number of shares of common stock reserved for issuance under the 2011 Plan automatically increases on January 1 of each year, continuing through January 1, 2021, by 4% of the total number of shares of the Company’s common stock outstanding on December 31 st Upon adoption of the 2011 Plan, the Company eliminated the authorization for any unissued shares previously reserved under the Company’s 2006 Plan. The stock awards previously issued under the 2006 Plan remain in effect in accordance with the terms of the 2006 Plan. The following table summarizes the Company’s 2006 and 2011 Plan stock option activity: Weighted Weighted Average Average Aggregate Number of Exercise Contractual Intrinsic Options Price Term (in years) Value (1) Outstanding - December 31, 2013 1,832,851 $ 5.26 Granted 753,250 12.35 Exercised (39,980 ) 2.16 Forfeited (60,021 ) 10.28 Expired (1,541 ) 7.22 Outstanding - December 31, 2014 2,484,559 7.34 Granted 790,850 26.73 Exercised (417,999 ) 6.40 Forfeited (43,645 ) 15.71 Expired - - Outstanding - December 31, 2015 2,813,765 $ 12.80 Granted 1,151,158 24.35 Exercised (95,180 ) 5.17 Forfeited (78,225 ) 23.78 Expired (7,172 ) 19.48 Outstanding - December 31, 2016 3,784,346 16.26 7.14 $ 286,608 Exercisable - December 31, 2016 2,368,790 12.77 6.21 286,608 Vested and expected to vest at December 31, 2016 (2) 3,722,615 $ 16.14 7.12 $ 286,608 (1) Intrinsic value is the excess of the fair value of the underlying common shares as of December 31, 2016 over the weighted-average exercise price. (2) The number of stock options expected to vest takes into account an estimate of expected forfeitures. The following table summarizes certain information about all options outstanding as of December 31, 2016: Options Outstanding Options Exercisable Exercise Price Number of Options Weighted Average Remaining Contractual Term (in years) Number of Options Weighted Average Remaining Contractual Term (in years) $2.09 - $6.63 723,291 4.16 723,291 4.16 $6.64 - $11.35 827,697 6.68 647,130 5.94 $12.38 - $18.61 739,442 7.68 348,239 7.03 $19.25 - $31.13 1,280,166 8.68 547,646 8.46 $32.05 - $43.43 213,750 8.04 102,484 7.72 3,784,346 2,368,790 In 2016, the Company issued time-vested Restricted Stock Units (RSUs) from the 2011 Equity Incentive Plan to certain employees, subject to continuous service with the Company at the vesting time. When vested, the RSU represented the right to be issued the number of shares of the Company’s common stock that is equal to the number of RSUs granted. A summary of the activity related to the Company’s RSUs is as follows: Number of Weighted Restricted Average Stock Units Grant-Date Outstanding Fair Value Balance - December 31, 2015 - $ - Granted 50,000 7.70 Exercised - - Forfeited - - Expired - - Balance - December 31, 2016 50,000 7.70 Vested at December 31, 2016 - $ - During the years ended December 31, 2016, 2015 and 2014, the Company recorded $14.3 million, $5.9 million, and $3.1 million in share-based compensation expense, respectively. As of December 31, 2016, approximately $13.7 million of total unrecognized compensation cost related to unvested share options is expected to be recognized over a weighted-average period of 2.57 years, and approximately $0.3 million of total unrecognized compensation cost related to unvested restricted stock units is expected to be recognized over a weighted-average period of .94 years. During the year ended December 31, 2016, the Company received $0.5 million in cash proceeds from the exercise of stock options through the course of the year. Other information pertaining to the Company’s stock option awards is as follows (in thousands, except per share data): Fiscal Years Ended December 31, December 31, December 31, 2016 2015 2014 Weighted average grant date fair value per share of options $ 15.55 $ 17.00 $ 8.58 Total intrinsic value of options exercised $ 1,283 $ 11,970 $ 313 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes No provision for U.S. Federal or state income taxes has been recorded as the Company has incurred net operating losses since inception. Significant components of the Company’s deferred income tax assets as of December 31, 2016 and 2015 consist of the following (in thousands): 2016 2015 Non-current Deferred income tax assets Tax loss carryforwards $ 121,953 $ 86,600 Contribution carryforwards 24 27 Tax credits 15,212 12,719 Start-up costs & other intangibles 5,984 5,661 Share-based compensation 7,161 3,315 Deferred revenue 4,033 4,049 Other assets 566 350 Total net deferred income taxes, non-current 154,933 112,721 Less valuation allowance (154,933 ) (112,721 ) Total net deferred income tax $ - $ - At December 31, 2016 and 2015, the Company provided a full valuation allowance against its net deferred tax assets since at that time, the Company could not assert that it was more likely than not that these deferred tax assets would be realized. There was an increase in the valuation allowance in the current year in the amount of $42.2 million. The table below summarizes changes in the deferred tax valuation allowance (in thousands): 2016 2015 2014 Balance at beginning of year $ 112,721 $ 76,286 $ 52,858 Charges to costs and expenses 42,212 36,435 23,428 Write-offs - - - Balance at end of year $ 154,933 $ 112,721 $ 76,286 As of December 31, 2016, the Company had federal net operating loss carryforwards of approximately $353.5 million and state net operating loss carryforwards of approximately $244.8 million. The net operating loss carryforwards begin to expire in 2026 and 2021 for federal and state tax purposes, respectively. The Company's federal and state net operating loss carryforwards include approximately $9.6 million of excess tax benefits related to deductions from the exercise of stock options. The tax benefit of these deductions has not been recognized in deferred tax assets. If utilized, the benefits from these deductions will be recorded as adjustments to additional paid-in capital. The Company also had federal research and development credit carryforwards of approximately $11.6 million which begin to expire in 2026, federal orphan drug credits carryforwards of approximately $3.1 million which begin to expire in 2033, federal charitable contribution carryforwards of approximately $0.1 million which begin to expire in 2017, and state credit carryforwards of approximately $0.8 million, which begin to expire in 2018. The Tax Reform Act of 1986 contains provisions which limit the ability to utilize the net operating loss carryforwards in the case of certain events including significant changes in ownership interests. If the Company’s net operating loss carryforwards are limited, and the Company has taxable income which exceeds the permissible yearly net operating loss carryforward, the Company would incur a federal income tax liability even though net operating loss carryforwards would be available in future years. The reasons for the difference between actual income tax expense (benefit) for the years ended December 31, 2016, 2015 and 2014 and the amount computed by applying the statutory federal income tax rate to losses before income tax (benefit) are as follows: 2016 2015 2014 Amount % of Pretax Earnings Amount % of Pretax Earnings Amount % of Pretax Earnings United States federal tax at statutory rate $ (40,107 ) 34 % $ (30,978 ) 34 % $ (20,961 ) 34 % State taxes (net of federal benefit) (1,895 ) 2 % (1,593 ) 2 % (1,239 ) 2 % Nondeductible expenses 1,196 (1 %) 1,380 (1 %) 890 (1 %) Credits (2,493 ) 2 % (4,959 ) 5 % (3,329 ) 5 % Adjustment for state rate change 1,142 (1 %) 722 (1 %) 1,249 (2 %) Other, net (55 ) 0 % (1,007 ) 1 % (38 ) 0 % Change in valuation allowance 42,212 (36 %) 36,435 (40 %) 23,428 (38 %) Provision for income taxes $ - 0 % $ - 0 % $ - 0 % During 2016, North Carolina enacted legislation to reduce the state corporate income tax rate from 4% to 3% for tax years 2017 and beyond. As a result of the new enacted tax rate, the Company adjusted its deferred tax assets as of December 31, 2016 by applying the lower rate, which resulted in a decrease in the deferred tax assets and a corresponding decrease to the valuation allowance of approximately $ 1.1 million. As of December 31, 2016 and 2015, the Company had no unrecognized tax benefits. The Company’s policy is to recognize interest and penalties related to uncertain tax positions in the provision for income taxes. As of December 31, 2016 and 2015, the Company had no accrued interest or penalties related to uncertain tax positions. The Company has analyzed its filing positions in all significant federal and state jurisdictions where it is required to file income tax returns, as well as open tax years in these jurisdictions. With few exceptions, the Company is no longer subject to United States Federal, state, and local tax examinations by tax authorities for years before 2013 although carryforward attributes that were generated prior to 2013 may still be adjusted upon examination by the taxing authorities if they either have been or will be used in a future period. No income tax returns are currently under examination by taxing authorities. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 12. Net Loss Per Share Basic and diluted net loss per common share was determined by dividing net loss by the weighted average common shares outstanding during the period. The Company’s potentially dilutive shares, which include redeemable warrants, common share options and restricted stock units, have not been included in the computation of diluted net loss per share for all periods as the result would be antidilutive. The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: December 31, 2016 2015 2014 Warrants outstanding 94,912 132,464 330,585 Stock options outstanding 3,560,102 2,910,694 2,411,891 Restricted stock units 3,005 - - 3,658,019 3,043,158 2,742,476 |
Selected Quarterly Data
Selected Quarterly Data | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Data | 13. Selected Quarterly Data (unaudited, in thousands, except for loss per share data) Quarter Ended March 31, June 30, September 30, December 31, 2016 2016 2016 2016 Revenue Contract research $ 2,679 $ 3,420 $ 3,972 $ 3,606 License - - - 4,339 Supply - - - - Total revenue $ 2,679 $ 3,420 $ 3,972 $ 7,945 Operating expenses Research and development 23,529 16,018 21,096 21,043 General and administrative 8,324 11,988 15,021 18,205 Loss from operations (29,174 ) (24,586 ) (32,145 ) (31,303 ) Interest income 98 104 128 145 Interest expense (330 ) (323 ) (295 ) (280 ) Net loss $ (29,406 ) $ (24,805 ) $ (32,312 ) $ (31,438 ) Net loss per share - basic and diluted $ (0.61 ) $ (0.51 ) $ (0.62 ) $ (0.60 ) Shares used in calculating basic and diluted net loss per share 47,853 48,898 52,073 52,389 Quarter Ended March 31, June 30, September 30, December 31, 2015 2015 2015 2015 Revenue Contract research $ 2,076 $ 3,171 $ 2,497 $ 4,704 License 10,000 - - - Supply 1,887 1,883 - 1,090 Total revenue $ 13,963 $ 5,054 $ 2,497 $ 5,794 Operating expenses Research and development 26,118 23,676 23,541 20,018 General and administrative 4,650 5,732 5,848 6,641 Loss from operations (16,805 ) (24,354 ) (26,892 ) (20,865 ) Interest income 2 2 - 5 Interest expense (614 ) (617 ) (679 ) (296 ) Net loss $ (17,417 ) $ (24,969 ) $ (27,571 ) $ (21,156 ) Net loss per share - basic and diluted $ (0.41 ) $ (0.57 ) $ (0.63 ) $ (0.48 ) Shares used in calculating basic and diluted net loss per share 42,671 43,686 43,911 43,976 |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Event | 14. Subsequent Event In February 2017, as a consequence of the solithromycin complete response letter the Company received from the FDA, and subsequent discussions with the FDA, resulting in the delay of the potential approval of solithromycin, the Company initiated companywide cost and personnel reductions. These actions have resulted in an approximately 67% reduction in the Company’s workforce from 136 to 45 employees, and significant reductions in external spending related to commercial preparedness and non-essential activities. The principal objective of the reductions is to enable the Company to conserve its financial resources as it evaluates its path forward on its existing pipeline and potential business development opportunities. As the Company progresses its internal programs, it is also actively engaged in a process to evaluate and assess external late-stage assets and other potential strategic business opportunities to determine the best use of its significant cash resources and clinical programs to deliver value to patients and shareholders through internal and/or potential external opportunities. In connection with the reduction, the Company expects to record an aggregate charge related to one-time termination benefits of approximately $3.5 million in 2017. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Principles of Consolidation and Basis of Presentation | Principles of Consolidation and Basis of Presentation The accompanying consolidated financial statements include the accounts and results of operations of Cempra and its wholly owned subsidiaries. The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of these 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 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. |
Cash Equivalents and Concentrations of Risks | Cash Equivalents and Concentrations of Risks The Company considers all highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash deposits are all in financial institutions in the U.S. The Company maintains cash in accounts which are in excess of federally insured limits. The Company places cash and equivalents in financial institutions with high credit ratings. |
Receivables | Receivables Receivables consist of amounts billed and amounts earned but unbilled under the Company’s licensing agreements or its contract with the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services (“BARDA”) |
Furniture, Fixtures and Equipment, net | Furniture, Fixtures and Equipment, net Furniture, fixtures and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Furniture, fixtures, equipment and leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is credited or charged to income. Repairs and maintenance costs are expensed as incurred. Furniture, fixtures and equipment are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. If there is an impairment, a loss is recognized. |
Income Taxes | Income Taxes Income taxes are computed using the asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company’s financial statements. In estimating future tax consequences, the Company considers all expected future events other than enactment of changes in tax laws or rates. A valuation allowance is recorded, if necessary, to reduce net deferred tax assets to their realizable values if management does not believe it is more likely than not that the net deferred tax assets will be realized. |
Segment and Geographic Information | Segment and Geographic Information Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company operates and manages its business as one operating segment and all of the Company’s operations are in North America. |
Intellectual Property | Intellectual Property The Company’s policy is to file patent applications to protect technology, inventions and improvements that are considered important to the development of its business. The patent positions of technology companies, including the Company, are uncertain and involve complex legal and factual questions for which important legal principles are largely unresolved. The Company accounts for its intellectual property under the guidance of the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 350, Intangibles—Goodwill and Other. |
Research and Development Expenses | Research and Development Expenses Research and development (“R&D”) expenses include direct and indirect R&D costs. Direct R&D consists principally of external costs, such as fees paid to investigators, consultants, central laboratories and clinical research organizations, including costs incurred in connection with clinical trials, and related clinical trial fees and all employee-related expenses for those employees working in research and development functions, including stock-based compensation for R&D personnel. Indirect R&D costs include insurance or other indirect costs related to the Company’s research and development function to specific product candidates. R&D costs are expensed as incurred. Expenses paid but not yet incurred are recorded in prepaid expenses. The Company expenses pre-approval inventory as R&D until regulatory approval is received. |
Clinical Trial Accruals | Clinical Trial Accruals As part of the process of preparing financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with conducting clinical trials. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates through discussions with applicable personnel and outside service providers as to the progress of trials, or the services completed. During the course of a clinical trial, the Company adjusts its rate of clinical trial expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. The Company’s clinical trial accrual is dependent upon the timely and accurate reporting of fee billings and pass-through expenses from contract research organizations and other third-party vendors as well as the timely processing of any change orders from the contract research organizations. |
Revenue Recognition | Revenue Recognition The Company’s revenue generally consists of research related revenue under federal contracts, supply revenue and licensing revenue related to non-refundable upfront fees, milestone payments and royalties earned under license agreements. Revenue is recognized when the following criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery of the products and/or services has occurred; (3) the selling price is fixed or determinable; and (4) collectability is reasonably assured. For arrangements that involve the delivery of more than one element, each product, service and/or right to use assets is evaluated to determine whether it qualifies as a separate unit of accounting. This determination is based on whether the deliverable has “stand-alone value” to the customer. The consideration that is fixed or determinable is then allocated to each separate unit of accounting based on the relative selling prices of each deliverable. The consideration allocated to each unit of accounting is recognized as the related goods and services are delivered, limited to the consideration that is not contingent upon future deliverables. When an arrangement is accounted for as a single unit of accounting, the Company determines the period over which the performance obligations will be performed and revenue recognized. Milestone payments are recognized when earned, provided that (i) the milestone event is substantive; (ii) there is no ongoing performance obligation related to the achievement of the milestone earned; and (iii) it would result in additional payments. Milestone payments are considered substantive if all of the following conditions are met: the milestone payment is non-refundable; achievement of the milestone was not reasonably assured at the inception of the arrangement; substantive effort is involved to achieve the milestone; and the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement, and the related risk associated with the achievement of the milestone. Contingent-based payments the Company may receive under a license agreement will be recognized when received. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing the net loss by the weighted average number of common stock shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common stock shares adjusted for the dilutive effect of common stock equivalent shares outstanding during the period. Common stock equivalents consist of convertible senior notes (using the “as if converted” method), stock options, restricted stock shares and stock warrants. Common equivalent shares are excluded from the computation in periods in which they have an anti-dilutive effect on earnings per share. |
Share-Based Compensation | Share-Based Compensation The Company accounts for share-based compensation following the provisions of FASB ASC Topic 718, Stock Compensation The Company recorded the following share-based compensation expense in accordance with ASC Topic 718 (in thousands): Year Ended December 31, 2016 2015 2014 Research and development $ 2,942 $ 1,948 $ 811 General and administrative 11,381 3,940 2,294 Total $ 14,323 $ 5,888 $ 3,105 Allocations to research and development and general and administrative expense are based upon the department to which the associated employee reported. No related tax benefits of the share-based compensation expense have been recognized. |
Valuation Assumptions for Stock Option Plans | Valuation Assumptions for Stock Option Plans The employee share-based compensation expense recognized was determined using the Black-Scholes option-pricing model. Option-pricing models require the input of subjective assumptions and these assumptions can vary over time. The weighted-average assumptions used to determine the fair value of each option grant are as follows: 2016 2015 2014 Estimated dividend yield 0.0 % 0.0 % 0.0 % Expected share price volatility 76.7 % 74.3 % 82.3 % Risk-free interest rate 1.6 % 1.7 % 2.0 % Expected life of option (in years) 5.5 5.6 5.8 Weighted-average fair value per share $ 15.55 $ 17.00 $ 8.58 Expected stock price volatility is based on an average of the Company’s volatility and several peer public companies due to the Company’s limited history. For purposes of identifying peer companies, the Company considered characteristics such as industry, market capitalization, length of trading history, similar vesting terms and in-the-money option status. The risk-free rate is based on the U.S. Treasury yield curve during the expected life of the option. The dividend yield percentage is zero because the Company neither currently pays dividends nor intends to do so during the expected option term. The expected term represents the average time that options are expected to be outstanding. Due to a lack of term length data, the Company elected to use the mid-point between the vesting date and the contractual term as the expected term for employee options and contractual life for non-employees options. This is in accordance with the simplified method prescribed in SEC Staff Accounting Bulletin No. 107, Share-Based Payment |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers. This new guidance clarifies the principles for recognizing revenue and develops a common revenue standard for U.S. GAAP. The guidance outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes the most current revenue recognition guidance. This guidance, as amended by ASU 2015-14, is effective for fiscal years and interim periods within those years beginning after December 15, 2017, which is effective for the Company for the year ending December 31, 2018. In March 2016, the FASB issued ASU 2016-08, Revenue from Contracts with Customers: Principal versus Agent Considerations, which clarifies the implementation guidance on principal versus agent considerations. In April 2016, the FASB issued ASU 2016-10, Revenue from Contracts with Customers: Identifying Performance Obligations and Licensing, which clarifies an entity’s identification of its performance obligations in a contract. The update also clarifies the guidance regarding an entity’s evaluation of the nature of its promise to grant a license of intellectual property and whether or not that revenue is recognized over time or at a point in time. In May 2016, the FASB issued ASU 2016-12, Revenue from Contracts with Customers: Narrow-Scope Improvements and Practical Expedients, which amends the guidance in the new revenue standard on collectability, non-cash consideration, presentation of sales tax, and transition. In December 2016, the FASB issued ASU 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers which increases shareholders’ awareness of the proposals and expedites improvements to Update 2014-09. The amendments are intended to address implementation issues that were raised by stakeholders and provide additional practical expedients to reduce the cost and complexity of applying the new revenue standard. These pronouncements have the same effective date as the new revenue standard. In December 2016, the Company received a Complete Response Letter (“CRL”) from the FDA which outlined a number of steps the Company would be required to complete prior to commercial approval of solithromycin. Based on the nature of the items outlined in the CRL, the launch of solithromycin for the treatment of community acquired bacterial pneumonia, has been delayed. As a result, the Company has determined that it will not early adopt the new revenue recognition guidance in 2017. The Company has evaluated the contract research agreement with BARDA, and does not anticipate a material impact on the financial statements. The Company is currently evaluating the license agreement with Toyama to determine the impact that the implementation of this standard will have on the financial statements, if any. The Company plans to use the full retrospective method of adoption effective January 1, 2018. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements-Going Concern. The guidance addresses management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. The Company has adopted this guidance as of December 31, 2016. In February 2016, the FASB issued ASU 2016-02, Leases. The new guidance will increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. This guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. The Company is currently evaluating the impact that the implementation of this standard will have on the Company’s consolidated financial statements. In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation. The new guidance simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. This guidance is effective for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements. In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments. ASU 2016-15 will make eight targeted changes to how cash receipts and cash payments are presented and classified in the statement of cash flows. This new guidance is effective for fiscal years beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements. In January 2017, the FASB issued ASU 2017-01, Business Combinations: Clarifying the Definition of a Business which revises the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. This new guidance is effective for fiscal years beginning after December 15, 2017. The Company is currently evaluating the impact that the implementation of this standard will have on the Company’s consolidated financial statements. |
Basis of Presentation (Tables)
Basis of Presentation (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Summary of Share-based Compensation Expense | The Company recorded the following share-based compensation expense in accordance with ASC Topic 718 (in thousands): Year Ended December 31, 2016 2015 2014 Research and development $ 2,942 $ 1,948 $ 811 General and administrative 11,381 3,940 2,294 Total $ 14,323 $ 5,888 $ 3,105 |
Weighted-Average Assumptions Used to Determine the Fair Value of Each Option Grant | The weighted-average assumptions used to determine the fair value of each option grant are as follows: 2016 2015 2014 Estimated dividend yield 0.0 % 0.0 % 0.0 % Expected share price volatility 76.7 % 74.3 % 82.3 % Risk-free interest rate 1.6 % 1.7 % 2.0 % Expected life of option (in years) 5.5 5.6 5.8 Weighted-average fair value per share $ 15.55 $ 17.00 $ 8.58 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | Accrued expenses are comprised of the following as of (in thousands): December 31, 2016 2015 Accrued severance $ 1,999 $ - Franchise tax 570 436 Accrued professional fees 145 642 Deferred rent 85 76 Accrued interest 80 99 Other accrued expenses 50 222 Total accrued expenses $ 2,929 $ 1,475 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Scheduled Maturities of Long-Term Debt | Scheduled maturities of long-term debt are as follows (in thousands): Year Ending December 31: 2017 6,667 2018 6,667 2019 2,222 Total 15,556 Less: Unamortized discount (229 ) Less: Current portion of long-term debt (6,667 ) Long-term debt $ 8,660 |
Commitments And Contingencies (
Commitments And Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments Required under Non-cancellable Operating Leases | Future minimum lease payments required under non-cancellable operating leases as of December 31, 2016 are as follows (in thousands): Operating Leases 2017 $ 744 2018 762 2019 503 2020 308 2021 and thereafter 42 Total minimum lease payments $ 2,359 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Common Stock Reserved for Future Issuance | The following table presents common stock reserved for future issuance for the following equity instruments as of December 31, 2016: Warrants to purchase common stock (1) 94,912 Options and restricted stock units: Outstanding under the 2006 Stock Plan 451,525 Outstanding under the 2011 Equity Incentive Plan 3,382,821 Available for future grants under the 2011 Equity Incentive Plan 2,900,230 Total common stock reserved for future issuance 6,829,488 (1) The Warrants to purchase common stock are exercisable at a price of $6.00 per share and expire in August 2018. |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Option Plans | The following table summarizes the Company’s 2006 and 2011 Plan stock option activity: Weighted Weighted Average Average Aggregate Number of Exercise Contractual Intrinsic Options Price Term (in years) Value (1) Outstanding - December 31, 2013 1,832,851 $ 5.26 Granted 753,250 12.35 Exercised (39,980 ) 2.16 Forfeited (60,021 ) 10.28 Expired (1,541 ) 7.22 Outstanding - December 31, 2014 2,484,559 7.34 Granted 790,850 26.73 Exercised (417,999 ) 6.40 Forfeited (43,645 ) 15.71 Expired - - Outstanding - December 31, 2015 2,813,765 $ 12.80 Granted 1,151,158 24.35 Exercised (95,180 ) 5.17 Forfeited (78,225 ) 23.78 Expired (7,172 ) 19.48 Outstanding - December 31, 2016 3,784,346 16.26 7.14 $ 286,608 Exercisable - December 31, 2016 2,368,790 12.77 6.21 286,608 Vested and expected to vest at December 31, 2016 (2) 3,722,615 $ 16.14 7.12 $ 286,608 (1) Intrinsic value is the excess of the fair value of the underlying common shares as of December 31, 2016 over the weighted-average exercise price. (2) The number of stock options expected to vest takes into account an estimate of expected forfeitures. |
Options Outstanding | The following table summarizes certain information about all options outstanding as of December 31, 2016: Options Outstanding Options Exercisable Exercise Price Number of Options Weighted Average Remaining Contractual Term (in years) Number of Options Weighted Average Remaining Contractual Term (in years) $2.09 - $6.63 723,291 4.16 723,291 4.16 $6.64 - $11.35 827,697 6.68 647,130 5.94 $12.38 - $18.61 739,442 7.68 348,239 7.03 $19.25 - $31.13 1,280,166 8.68 547,646 8.46 $32.05 - $43.43 213,750 8.04 102,484 7.72 3,784,346 2,368,790 |
Summary of RSUs Activity | A summary of the activity related to the Company’s RSUs is as follows: Number of Weighted Restricted Average Stock Units Grant-Date Outstanding Fair Value Balance - December 31, 2015 - $ - Granted 50,000 7.70 Exercised - - Forfeited - - Expired - - Balance - December 31, 2016 50,000 7.70 Vested at December 31, 2016 - $ - |
Schedule of Other Information Pertaining to Stock Option Awards | Other information pertaining to the Company’s stock option awards is as follows (in thousands, except per share data): Fiscal Years Ended December 31, December 31, December 31, 2016 2015 2014 Weighted average grant date fair value per share of options $ 15.55 $ 17.00 $ 8.58 Total intrinsic value of options exercised $ 1,283 $ 11,970 $ 313 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Significant Components of Company's Deferred Income Tax Assets | Significant components of the Company’s deferred income tax assets as of December 31, 2016 and 2015 consist of the following (in thousands): 2016 2015 Non-current Deferred income tax assets Tax loss carryforwards $ 121,953 $ 86,600 Contribution carryforwards 24 27 Tax credits 15,212 12,719 Start-up costs & other intangibles 5,984 5,661 Share-based compensation 7,161 3,315 Deferred revenue 4,033 4,049 Other assets 566 350 Total net deferred income taxes, non-current 154,933 112,721 Less valuation allowance (154,933 ) (112,721 ) Total net deferred income tax $ - $ - |
Summary of Changes in the Deferred Tax Valuation Allowance | The table below summarizes changes in the deferred tax valuation allowance (in thousands): 2016 2015 2014 Balance at beginning of year $ 112,721 $ 76,286 $ 52,858 Charges to costs and expenses 42,212 36,435 23,428 Write-offs - - - Balance at end of year $ 154,933 $ 112,721 $ 76,286 |
Difference Between Actual Income Tax Expense (Benefit) and Statutory Federal Income Tax Rate | The reasons for the difference between actual income tax expense (benefit) for the years ended December 31, 2016, 2015 and 2014 and the amount computed by applying the statutory federal income tax rate to losses before income tax (benefit) are as follows: 2016 2015 2014 Amount % of Pretax Earnings Amount % of Pretax Earnings Amount % of Pretax Earnings United States federal tax at statutory rate $ (40,107 ) 34 % $ (30,978 ) 34 % $ (20,961 ) 34 % State taxes (net of federal benefit) (1,895 ) 2 % (1,593 ) 2 % (1,239 ) 2 % Nondeductible expenses 1,196 (1 %) 1,380 (1 %) 890 (1 %) Credits (2,493 ) 2 % (4,959 ) 5 % (3,329 ) 5 % Adjustment for state rate change 1,142 (1 %) 722 (1 %) 1,249 (2 %) Other, net (55 ) 0 % (1,007 ) 1 % (38 ) 0 % Change in valuation allowance 42,212 (36 %) 36,435 (40 %) 23,428 (38 %) Provision for income taxes $ - 0 % $ - 0 % $ - 0 % |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Antidilutive Securities Excluded from Computation of Diluted Weighted Average Shares Outstanding | The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: December 31, 2016 2015 2014 Warrants outstanding 94,912 132,464 330,585 Stock options outstanding 3,560,102 2,910,694 2,411,891 Restricted stock units 3,005 - - 3,658,019 3,043,158 2,742,476 |
Selected Quarterly Data (Tables
Selected Quarterly Data (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Selected Quarterly Data | Quarter Ended March 31, June 30, September 30, December 31, 2016 2016 2016 2016 Revenue Contract research $ 2,679 $ 3,420 $ 3,972 $ 3,606 License - - - 4,339 Supply - - - - Total revenue $ 2,679 $ 3,420 $ 3,972 $ 7,945 Operating expenses Research and development 23,529 16,018 21,096 21,043 General and administrative 8,324 11,988 15,021 18,205 Loss from operations (29,174 ) (24,586 ) (32,145 ) (31,303 ) Interest income 98 104 128 145 Interest expense (330 ) (323 ) (295 ) (280 ) Net loss $ (29,406 ) $ (24,805 ) $ (32,312 ) $ (31,438 ) Net loss per share - basic and diluted $ (0.61 ) $ (0.51 ) $ (0.62 ) $ (0.60 ) Shares used in calculating basic and diluted net loss per share 47,853 48,898 52,073 52,389 Quarter Ended March 31, June 30, September 30, December 31, 2015 2015 2015 2015 Revenue Contract research $ 2,076 $ 3,171 $ 2,497 $ 4,704 License 10,000 - - - Supply 1,887 1,883 - 1,090 Total revenue $ 13,963 $ 5,054 $ 2,497 $ 5,794 Operating expenses Research and development 26,118 23,676 23,541 20,018 General and administrative 4,650 5,732 5,848 6,641 Loss from operations (16,805 ) (24,354 ) (26,892 ) (20,865 ) Interest income 2 2 - 5 Interest expense (614 ) (617 ) (679 ) (296 ) Net loss $ (17,417 ) $ (24,969 ) $ (27,571 ) $ (21,156 ) Net loss per share - basic and diluted $ (0.41 ) $ (0.57 ) $ (0.63 ) $ (0.48 ) Shares used in calculating basic and diluted net loss per share 42,671 43,686 43,911 43,976 |
Basis of Presentation - Additio
Basis of Presentation - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2016USD ($)Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Allowance for doubtful accounts receivable recorded | $ 0 |
Number of operating segments | Segment | 1 |
Tax benefits of the share-based compensation expense recognized | $ 0 |
Dividend yield percentage | 0.00% |
Basis of Presentation - Summary
Basis of Presentation - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Summary of share-based compensation expense | |||
Share-based compensation | $ 14,323 | $ 5,888 | $ 3,105 |
Research and Development | |||
Summary of share-based compensation expense | |||
Share-based compensation | 2,942 | 1,948 | 811 |
General and Administrative | |||
Summary of share-based compensation expense | |||
Share-based compensation | $ 11,381 | $ 3,940 | $ 2,294 |
Basis of Presentation - Weighte
Basis of Presentation - Weighted-Average Assumptions Used to Determine the Fair Value of Each Option Grant (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Assumptions used to determine the fair value of each option grant | |||
Estimated dividend yield for employees | 0.00% | 0.00% | 0.00% |
Expected share price volatility for employees | 76.70% | 74.30% | 82.30% |
Risk-free interest rate for employees | 1.60% | 1.70% | 2.00% |
Expected life of option (in years) for employees | 5 years 6 months | 5 years 7 months 6 days | 5 years 9 months 18 days |
Weighted-average fair value per share for employees | $ 15.55 | $ 17 | $ 8.58 |
Fair Value of Financial Instr35
Fair Value of Financial Instruments - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Transfers between levels of the fair value hierarchy | $ 0 | |
Term Loan | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Carrying value of notes | 15,300,000 | |
Recurring Basis | Money Market Funds | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Assets classified as fair value of financial instruments | $ 228,500,000 | $ 129,000,000 |
Significant Agreements and Co36
Significant Agreements and Contracts - Additional Information (Details) | Oct. 31, 2016USD ($) | Jan. 29, 2016USD ($) | Aug. 31, 2014USD ($) | May 31, 2013USD ($) | Oct. 31, 2016USD ($) | Sep. 30, 2016USD ($) | May 31, 2015USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Jul. 31, 2012USD ($) | Jul. 31, 2010USD ($) | Dec. 31, 2016USD ($)Segment | Sep. 30, 2016USD ($) | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Jun. 30, 2012USD ($) | Dec. 31, 2016USD ($)SegmentProductDeliverablesshares | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2016USD ($)Segment | Feb. 29, 2016USD ($) |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Contract research | $ 3,606,000 | $ 3,972,000 | $ 3,420,000 | $ 2,679,000 | $ 4,704,000 | $ 2,497,000 | $ 3,171,000 | $ 2,076,000 | $ 13,677,000 | $ 12,448,000 | $ 9,609,000 | ||||||||||||||
Deferred revenue | 16,987,000 | $ 11,326,000 | $ 16,987,000 | 11,326,000 | $ 16,987,000 | ||||||||||||||||||||
Optimer Pharmaceuticals Inc | Collaborative Arrangement | |||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Common shares issued to Optimer in exchange for license | shares | 125,646 | ||||||||||||||||||||||||
Fair value of common shares issued to Optimer | $ 200,000 | ||||||||||||||||||||||||
Milestone payment paid | $ 1,000,000 | $ 500,000 | |||||||||||||||||||||||
Milestone payment owed upon FDA approval | 9,500,000 | 9,500,000 | 9,500,000 | ||||||||||||||||||||||
Aggregate amount of milestone payment | 27,500,000 | $ 27,500,000 | 27,500,000 | ||||||||||||||||||||||
Number of products required to be developed through FDA approval | Product | 4 | ||||||||||||||||||||||||
Royalty payment based on annual net sales description | The Company will also pay tiered mid-single-digit royalties based on the amount of annual net sales of its approved products. | ||||||||||||||||||||||||
The Scripps Research Institute | |||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Milestone payment paid | $ 200,000 | ||||||||||||||||||||||||
Royalty payment based on annual net sales description | Under the terms of the agreement, the Company must pay TSRI low single-digit percentage royalties on the net sales of the products covered by the TSRI patents for the life of the TSRI patents, a low single-digit percentage of non-royalty sublicensing revenue received with respect to countries in the nonexclusive territory and a mid-single-digit percentage of sublicensing revenue received with respect to countries in the exclusive territory, with the sublicensing revenue royalty in the exclusive territory and the sales royalties subject to certain reductions under certain circumstances. | ||||||||||||||||||||||||
Non refundable license issue fee | $ 400,000 | ||||||||||||||||||||||||
Eligible milestone payment | $ 1,100,000 | ||||||||||||||||||||||||
The Scripps Research Institute | First Three Years | |||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Annual maintenance fees | 50,000 | ||||||||||||||||||||||||
The Scripps Research Institute | Fourth Through Six Years | |||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Annual maintenance fees | 85,000 | ||||||||||||||||||||||||
Biomedical Advanced Research and Development Authority | |||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Value of cost plus fixed fee development contract with base performance segment | $ 18,700,000 | $ 18,700,000 | $ 18,700,000 | ||||||||||||||||||||||
Number of option work segments | Segment | 4 | 4 | 4 | ||||||||||||||||||||||
Cumulative value of cost plus fixed fee development contract with base performance segment of four option work segments | $ 68,200,000 | $ 68,200,000 | $ 68,200,000 | ||||||||||||||||||||||
Number of options under cost plus fixed fee arrangements | Segment | 3 | ||||||||||||||||||||||||
Number of options under cost sharing arrangement without fixed fee | Segment | 1 | ||||||||||||||||||||||||
Estimated period of performance for the base performance segment | 2018-05 | ||||||||||||||||||||||||
Aggregate milestone payments receivable under license agreement | 2013-05 | ||||||||||||||||||||||||
Estimated period of performance for the base performance segment ending date | 2016-02 | ||||||||||||||||||||||||
Contract research | $ 13,700,000 | $ 12,400,000 | $ 9,600,000 | ||||||||||||||||||||||
Biomedical Advanced Research and Development Authority | Second Option Work | |||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Value of cost plus fixed fee development contract with base performance segment | 16,000,000 | $ 16,000,000 | 16,000,000 | ||||||||||||||||||||||
Aggregate milestone payments receivable under license agreement | 2014-11 | ||||||||||||||||||||||||
Estimated period of performance for the base performance segment ending date | 2017-04 | ||||||||||||||||||||||||
Biomedical Advanced Research and Development Authority | Third Option Work | |||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Value of cost plus fixed fee development contract with base performance segment | 33,500,000 | $ 33,500,000 | 33,500,000 | $ 25,500,000 | |||||||||||||||||||||
Increase in value of cost plus fixed fee development contract with base performance segment | $ 8,000,000 | ||||||||||||||||||||||||
Toyama Chemical | |||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Contract research | 6,100,000 | ||||||||||||||||||||||||
Deferred revenue | $ 10,000,000 | $ 17,000,000 | $ 17,000,000 | $ 17,000,000 | |||||||||||||||||||||
Aggregate milestone payments | 60,000,000 | ||||||||||||||||||||||||
Milestone payment amount received | $ 10,000,000 | $ 10,000,000 | |||||||||||||||||||||||
Milestone payment recognized as revenue | $ 4,300,000 | $ 4,300,000 | $ 4,300,000 | $ 10,000,000 | $ 10,000,000 | ||||||||||||||||||||
Number of deliverables under license agreement | Deliverables | 6 | ||||||||||||||||||||||||
Supply agreement date | May 8, 2013 | ||||||||||||||||||||||||
FUJIFILM Finechemicals Co., Ltd. | |||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Manufacturing and supply agreement date | Jan. 18, 2016 | ||||||||||||||||||||||||
Prohibition term | For the term of the agreement plus an additional five years or until the expiration of the patents identified in the agreement, FFFC is prohibited from supplying, selling or distributing solithromycin to, or enabling the manufacture of solithromycin by, any third party for any purpose. The Company is not precluded from developing one or more alternative or additional sources of solithromycin. | ||||||||||||||||||||||||
Aggregate initial term of agreement | Dec. 16, 2025 | ||||||||||||||||||||||||
Macrolide Pharmaceuticals Inc | |||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Non refundable license issue fee | $ 400,000 | ||||||||||||||||||||||||
Option and license agreement | Jan. 29, 2016 | ||||||||||||||||||||||||
License agreement description | The option will run until the later to occur of (i) the earlier of (a) the date that the Company first obtains FDA approval for any product incorporating the Compound as an API, or (b) January 27, 2019, or (ii) the date that is six months after the earlier of (a) MP’s satisfaction of certain milestones, or (b) the Company’s termination of MP’s obligations under the evaluation program. | ||||||||||||||||||||||||
Aggregate amount of compensation related cost | $ 1,500,000 | ||||||||||||||||||||||||
Compensation related cost payment installment term | 18 months | ||||||||||||||||||||||||
Compensation related cost monthly installment amount | $ 83,333 | ||||||||||||||||||||||||
Duration of increase made in territory of exercise of option | 60 months | ||||||||||||||||||||||||
Non-refundable, non-creditable license fee | $ 1,000,000 | ||||||||||||||||||||||||
Amount of license fee payable upon exercise | 500,000 | ||||||||||||||||||||||||
Deemed royalty payments | 500,000 | ||||||||||||||||||||||||
Aggregate amount of royalty | 1,000,000 | ||||||||||||||||||||||||
Macrolide Pharmaceuticals Inc | License Fee Paid | |||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Non refundable license issue fee | 400,000 | ||||||||||||||||||||||||
Macrolide Pharmaceuticals Inc | Maximum | |||||||||||||||||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||||
Aggregate amount of milestone payment | $ 1,000,000 |
Accrued Expenses - Accrued Expe
Accrued Expenses - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Accrued expenses | ||
Accrued severance | $ 1,999 | |
Franchise tax | 570 | $ 436 |
Accrued professional fees | 145 | 642 |
Deferred rent | 85 | 76 |
Accrued interest | 80 | 99 |
Other accrued expenses | 50 | 222 |
Total accrued expenses | $ 2,929 | $ 1,475 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Jul. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2011 | Jun. 30, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | May 31, 2013 | |
Debt Instrument [Line Items] | ||||||||
Charge recorded on early extinguishment of debt | $ (153,000) | |||||||
Exercise price of warrant | $ 20.75 | |||||||
Cashless exercise of warrants resulted in issuance of shares | 97,931 | |||||||
First Hercules Warrant | ||||||||
Debt Instrument [Line Items] | ||||||||
Exercisable, share of common stock | 39,038 | |||||||
Warrants issued, per share | $ 10.25 | |||||||
Exercise price of warrant | 6.11 | |||||||
Exercise of warrants | 39,038 | |||||||
Second Hercules Warrant | ||||||||
Debt Instrument [Line Items] | ||||||||
Exercisable, share of common stock | 99,759 | |||||||
Exercise price of warrant | $ 6.11 | |||||||
Devisable amount of common stock equal to quotient | $ 600,000 | |||||||
Warrant expire date | May 31, 2023 | |||||||
Exercise of warrants | 99,759 | |||||||
Loan and Security Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Minimum unrestricted cash balance requirement | $ 15,000,000 | |||||||
Loan and Security Agreement | Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan and security agreement | $ 20,000,000 | |||||||
Eligible inventory percentage for additional borrowings | 75.00% | |||||||
Eligible accounts receivable for additional borrowings | 80.00% | |||||||
Proceeds received from the agreement | $ 20,000,000 | |||||||
Facility fee paid for the credit facility | $ 100,000 | |||||||
End date of interest-only payment | Apr. 30, 2016 | |||||||
Amortization period of principal and interest payments | 36 months | |||||||
Description of variable rate basis | 30 Day LIBOR | |||||||
Beginning date for principal plus interest payment | May 1, 2016 | |||||||
Loan and Security Agreement | Term Loan | LIBOR | ||||||||
Debt Instrument [Line Items] | ||||||||
Basis spread on variable rate | 5.20% | |||||||
Loan and Security Agreement | Revolver | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan and security agreement | $ 10,000,000 | |||||||
Maximum borrowing capacity if term loans are converted | 25,000,000 | |||||||
Facility fee paid for the credit facility | $ 200,000 | |||||||
Description of variable rate basis | 30 Day LIBOR | |||||||
Last date for repayment and reborrowed without penalty or premium | Dec. 31, 2017 | |||||||
Annual unused facility fee percentage | 0.25% | |||||||
Loan and Security Agreement | Revolver | LIBOR | ||||||||
Debt Instrument [Line Items] | ||||||||
Basis spread on variable rate | 4.20% | |||||||
December 2011 Note | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan and security agreement | $ 20,000,000 | $ 15,000,000 | ||||||
Long-term debt, borrowed | $ 17,700,000 | $ 10,000,000 | $ 5,200,000 | |||||
Term and prepayment fees | 1,200,000 | |||||||
Charge recorded on early extinguishment of debt | $ (300,000) | |||||||
Basis spread on variable rate | 3.25% | |||||||
Percentage of convertible notes | 9.55% | 9.55% | ||||||
Long-term debt, interest of borrowing | interest at the greater of (i) 9.55%, or (ii) the sum of 9.55% plus the prime lending rate, as published by the Wall Street Journal, minus 3.25% per annum | |||||||
Additional borrowing | $ 3,000,000 | |||||||
Extended date of additional borrowing | Dec. 26, 2014 | |||||||
December 2011 Note | Minimum | ||||||||
Debt Instrument [Line Items] | ||||||||
Additional borrowing | $ 3,000,000 | |||||||
December 2011 Note | Maximum | ||||||||
Debt Instrument [Line Items] | ||||||||
Additional borrowing | $ 10,000,000 |
Long-Term Debt - Scheduled Matu
Long-Term Debt - Scheduled Maturities of Long-Term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Scheduled maturities of Long-term Debt | ||
2,017 | $ 6,667 | |
2,018 | 6,667 | |
2,019 | 2,222 | |
Total | 15,556 | |
Less: Unamortized discount | (229) | |
Less: Current portion of long-term debt | (6,667) | $ (4,444) |
Long-term debt | $ 8,660 | $ 15,258 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Future Minimum Lease Payments Required under Non-cancellable Operating Leases (Details) $ in Thousands | Dec. 31, 2016USD ($) |
Schedule of future minimum lease payments required under non-cancellable operating leases | |
2,017 | $ 744 |
2,018 | 762 |
2,019 | 503 |
2,020 | 308 |
2021 and thereafter | 42 |
Total minimum lease payments | $ 2,359 |
Commitments and Contingencies41
Commitments and Contingencies - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2016USD ($)Installment | Dec. 31, 2016USD ($) | Dec. 31, 2016USD ($)Lawsuit | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Loss Contingencies [Line Items] | |||||
Rent expense | $ 700,000 | $ 400,000 | $ 200,000 | ||
Retirement and Consulting Agreement | Dr. Prabhavathi Fernandes | |||||
Loss Contingencies [Line Items] | |||||
Accrued severance, description | In December 2016, the Company entered into a Retirement and Consulting Agreement with then current CEO, Dr. Prabhavathi Fernandes, whereby, for one year, subject to monthly extensions by mutual agreement, she will provide consulting services to the Company for up to 20 hours per week. | ||||
Consulting service period | 1 year | ||||
Consulting fees per month | $ 35,000 | $ 35,000 | $ 35,000 | ||
Recognized stock compensation expense | 4,200,000 | ||||
Payable for waiver of notice period | 45,000 | 45,000 | 45,000 | ||
Annual bonus for termination of employment | $ 280,260 | 280,260 | 280,260 | ||
Annual base salary payable, period | 18 months | ||||
Annual base salary payable | $ 540,000 | 540,000 | $ 540,000 | ||
Target bonus payable, description | In addition, the Company will pay Dr. Fernandes an amount equal to one and one half times her Target Bonus (as defined in her employment agreement), based upon the average percentage of achievement of target objectives for the prior three years | ||||
Target bonus payable achievement period | 3 years | ||||
Bonus payable based on achievement of target | $ 420,390 | $ 420,390 | $ 420,390 | ||
Number of monthly equal installments for additional bonus payment | Installment | 18 | ||||
Maximum | Retirement and Consulting Agreement | Dr. Prabhavathi Fernandes | |||||
Loss Contingencies [Line Items] | |||||
Consulting services per week | 20 hours | ||||
Securities Class Action | |||||
Loss Contingencies [Line Items] | |||||
Lawsuit commencement date | Nov. 4, 2016 | ||||
Lawsuit action domicile | United States District Court, Middle District of North Carolina, Durham Division | ||||
Name of defendant | officers | ||||
Allegations in the class period | between May 1, 2016 and November 1, 2016 | ||||
Loss contingency, actions determined by court | The plaintiff seeks to represent a class comprised of purchasers of the Company’s common stock during the Class Period and seeks damages, costs and expenses and such other relief as determined by the Court | ||||
Number of lawsuits filed | Lawsuit | 2 | ||||
Lawsuit filing date | November 22, 2016 and December 30, 2016 | ||||
Shareholder Derivative | |||||
Loss Contingencies [Line Items] | |||||
Lawsuit commencement date | Dec. 21, 2016 | ||||
Lawsuit action domicile | North Carolina Durham County Superior Court | ||||
Name of defendant | officers and directors | ||||
Lawsuit filing date | February 16, 2017 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 8 Months Ended | 12 Months Ended | ||||||
Jan. 31, 2016 | Jan. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | May 31, 2016 | Oct. 31, 2014 | Mar. 31, 2013 | |
Shareholders' Equity (Deficit) (Textual) [Abstract] | |||||||||
Common stock sale value | $ 52 | $ 52 | $ 44 | ||||||
Proceeds from issuance of common stock, net of underwriting discounts | $ 169,112 | $ 139,044 | $ 48,535 | ||||||
Issuance of common shares upon exercise of options, shares | 95,180 | 417,999 | 39,980 | ||||||
Weighted average exercise price of common stock | $ 5.17 | $ 6.40 | $ 2.16 | ||||||
Exercise price of warrant | $ 20.75 | ||||||||
Common Stock | |||||||||
Shareholders' Equity (Deficit) (Textual) [Abstract] | |||||||||
Number of common stocks issued through public offering | 4,166,667 | 6,037,500 | 4,140,307 | 8,306,974 | 6,037,500 | 4,092,525 | |||
Proceeds from issuance of common stock, net of underwriting discounts | $ 75,100 | $ 48,500 | |||||||
Commissions and expenses | $ 2,300 | ||||||||
Common share price | $ 24 | $ 24.50 | |||||||
Proceeds from issuance of common stock, net of underwriting discounts and offering costs | $ 93,800 | $ 138,800 | |||||||
Underwriting discounts and commissions, and expenses | $ 6,200 | $ 9,100 | |||||||
Issuance of common shares upon exercise of options, shares | 95,180 | 417,999 | |||||||
Weighted average exercise price of common stock | $ 5.17 | $ 6.40 | |||||||
Issuance of common shares upon exercise of warrants, shares | 60,309 | ||||||||
Exercise price of warrant | $ 6 | ||||||||
Commissions | $ 1,500 | ||||||||
Cowen And Company Limited Liability Company | At The Market Sales Agreement | |||||||||
Shareholders' Equity (Deficit) (Textual) [Abstract] | |||||||||
Common stock sale value | $ 150,000 | $ 25,000 | |||||||
Commission on sale of common stock under the ATM | 3.00% | 3.00% | |||||||
Cowen And Company Limited Liability Company | Amended And Restated Agreement | |||||||||
Shareholders' Equity (Deficit) (Textual) [Abstract] | |||||||||
Common stock sale value | $ 50,000 |
Shareholders' Equity - Common S
Shareholders' Equity - Common Stock Reserved for Future Issuance (Details) | Dec. 31, 2016shares |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 6,829,488 |
Warrants to purchase common stock | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 94,912 |
Options and Restricted Stock Units | 2006 Stock Plan | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 451,525 |
Options and Restricted Stock Units | 2011 Equity Incentive Plan | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 3,382,821 |
Options Available For Future Grants | 2011 Equity Incentive Plan | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 2,900,230 |
Shareholders' Equity - Common44
Shareholders' Equity - Common Stock Reserved for Future Issuance (Parenthetical) (Details) - Common Stock | 12 Months Ended |
Dec. 31, 2016$ / shares | |
Class Of Stock [Line Items] | |
Actual exercise price of warrants outstanding | $ 6 |
Warrants expiration period | 2018-08 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | May 31, 2015 | Dec. 31, 2013 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Options for shares issued and outstanding | 3,784,346 | 2,813,765 | 2,484,559 | 1,832,851 | |
Share-based compensation | $ 14.3 | $ 5.9 | $ 3.1 | ||
Unrecognized compensation cost | $ 13.7 | ||||
Expected weighted average recognition period, Unvested shares | 2 years 6 months 26 days | ||||
Cash proceeds from the exercise of stock options | $ 0.5 | ||||
Restricted Stock Units | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Unrecognized compensation cost | $ 0.3 | ||||
Expected weighted average recognition period, Unvested shares | 11 months 9 days | ||||
2006 Stock Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Options for shares issued and outstanding | 451,525 | ||||
2011 Equity Incentive Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Maximum number of shares authorized for future issuances | 6,601,735 | ||||
Options shares available under the 2011 Plan | 2,900,230 | ||||
Percent of annual increase in share reserved for future issuance | 4.00% | ||||
Date through which common stock reserved for issuance increases | Jan. 1, 2021 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Option Plans (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Number of Options, Outstanding | 2,813,765 | 2,484,559 | 1,832,851 |
Number of Options, Granted | 1,151,158 | 790,850 | 753,250 |
Number of Options, Exercised | (95,180) | (417,999) | (39,980) |
Number of Options, Forfeited | (78,225) | (43,645) | (60,021) |
Number of Options, Expired | (7,172) | (1,541) | |
Number of Options, Outstanding | 3,784,346 | 2,813,765 | 2,484,559 |
Number of Options, Exercisable - December 31, 2016 | 2,368,790 | ||
Number of Options, Vested and expected to vest at December 31, 2016 | 3,722,615 | ||
Weighted Average Exercise Price, Outstanding | $ 12.80 | $ 7.34 | $ 5.26 |
Weighted Average Exercise Price, Granted | 24.35 | 26.73 | 12.35 |
Weighted Average Exercise Price, Exercised | 5.17 | 6.40 | 2.16 |
Weighted Average Exercise Price, Forfeited | 23.78 | 15.71 | 10.28 |
Weighted Average Exercise Price, Expired | 19.48 | 7.22 | |
Weighted Average Exercise Price, Outstanding | 16.26 | $ 12.80 | $ 7.34 |
Weighted Average Exercise Price, Exercisable - December 31, 2016 | 12.77 | ||
Weighted Average Exercise Price, Vested and expected to vest at December 31, 2016 | $ 16.14 | ||
Weighted Average Contractual Term (in years), Outstanding | 7 years 1 month 21 days | ||
Weighted Average Contractual Term (in years), Exercisable - December 31, 2016 | 6 years 2 months 16 days | ||
Weighted Average Contractual Term (in years), Vested and expected to vest at December 31, 2016 | 7 years 1 month 13 days | ||
Aggregate Intrinsic Value, Outstanding | $ 286,608 | ||
Aggregate Intrinsic Value, Exercisable - December 31, 2016 | 286,608 | ||
Aggregate Intrinsic Value, Vested and expected to vest at December 31, 2016 | $ 286,608 |
Share-Based Compensation - Opti
Share-Based Compensation - Options Outstanding (Details) - $ / shares | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range [Line Items] | ||||
Number of Options Outstanding | 3,784,346 | 2,813,765 | 2,484,559 | 1,832,851 |
Number of Options, Exercisable | 2,368,790 | |||
Exercise Price $2.09 - $6.63 | ||||
Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range [Line Items] | ||||
Exercise price range lower range limit | $ 2.09 | |||
Exercise price range upper range limit | $ 6.63 | |||
Number of Options Outstanding | 723,291 | |||
Weighted Average Remaining Contractual Term (in years), Outstanding | 4 years 1 month 28 days | |||
Number of Options, Exercisable | 723,291 | |||
Weighted Average Remaining Contractual Term (in years), Exercisable | 4 years 1 month 28 days | |||
Exercise Price $6.64 - $11.35 | ||||
Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range [Line Items] | ||||
Exercise price range lower range limit | $ 6.64 | |||
Exercise price range upper range limit | $ 11.35 | |||
Number of Options Outstanding | 827,697 | |||
Weighted Average Remaining Contractual Term (in years), Outstanding | 6 years 8 months 5 days | |||
Number of Options, Exercisable | 647,130 | |||
Weighted Average Remaining Contractual Term (in years), Exercisable | 5 years 11 months 9 days | |||
Exercise Price $12.38 - $18.61 | ||||
Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range [Line Items] | ||||
Exercise price range lower range limit | $ 12.38 | |||
Exercise price range upper range limit | $ 18.61 | |||
Number of Options Outstanding | 739,442 | |||
Weighted Average Remaining Contractual Term (in years), Outstanding | 7 years 8 months 5 days | |||
Number of Options, Exercisable | 348,239 | |||
Weighted Average Remaining Contractual Term (in years), Exercisable | 7 years 11 days | |||
Exercise Price $19.25 - $31.13 | ||||
Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range [Line Items] | ||||
Exercise price range lower range limit | $ 19.25 | |||
Exercise price range upper range limit | $ 31.13 | |||
Number of Options Outstanding | 1,280,166 | |||
Weighted Average Remaining Contractual Term (in years), Outstanding | 8 years 8 months 5 days | |||
Number of Options, Exercisable | 547,646 | |||
Weighted Average Remaining Contractual Term (in years), Exercisable | 8 years 5 months 16 days | |||
Exercise Price $32.05 - $43.43 | ||||
Share Based Compensation Shares Authorized Under Stock Option Plans Exercise Price Range [Line Items] | ||||
Exercise price range lower range limit | $ 32.05 | |||
Exercise price range upper range limit | $ 43.43 | |||
Number of Options Outstanding | 213,750 | |||
Weighted Average Remaining Contractual Term (in years), Outstanding | 8 years 15 days | |||
Number of Options, Exercisable | 102,484 | |||
Weighted Average Remaining Contractual Term (in years), Exercisable | 7 years 8 months 19 days |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of RSUs Activity (Details) - Restricted Stock Units - 2011 Equity Incentive Plan | 12 Months Ended |
Dec. 31, 2016$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Number of Restricted Stock Units Outstanding, Granted | shares | 50,000 |
Number of Restricted Stock Units Outstanding, Balance - December 31, 2016 | shares | 50,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Weighted Average Grant-Date Fair Value, Granted | $ / shares | $ 7.70 |
Weighted Average Grant-Date Fair Value, Balance - December 31,2016 | $ / shares | $ 7.70 |
Share-Based Compensation - Sche
Share-Based Compensation - Schedule of Other Information Pertaining to Stock Option Awards (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Weighted average grant date fair value per share of options | $ 15.55 | $ 17 | $ 8.58 |
Total intrinsic value of options exercised | $ 1,283 | $ 11,970 | $ 313 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Contingency [Line Items] | ||
Increase (decrease) in Valuation Allowance | $ 42,200,000 | |
Federal net operating loss carryforwards | 353,500,000 | |
State net operating loss tax carryforwards | $ 244,800,000 | |
Federal net operating loss carryforwards, expires | net operating loss carryforwards begin to expire in 2026 and 2021 for federal and state tax purposes | |
Excess tax benefits from exercise of stock options | $ 9,600,000 | |
Federal research and development credit carryforwards, expires | 2,026 | |
Federal orphan drug credit carryforwards, expires | 2,033 | |
Federal charitable contribution carryforwards, expires | 2,017 | |
Federal state credit carryforwards, expires | 2,018 | |
Unrecognized tax benefits | $ 0 | $ 0 |
Accrued interest or penalties related to uncertain tax positions | 0 | $ 0 |
Change In Enacted Rate | ||
Income Tax Contingency [Line Items] | ||
Increase (decrease) in Valuation Allowance | (1,100,000) | |
Federal Research | ||
Income Tax Contingency [Line Items] | ||
Federal operating loss carryforwards | 11,600,000 | |
Federal Orphan Drug | ||
Income Tax Contingency [Line Items] | ||
Federal operating loss carryforwards | 3,100,000 | |
Federal Charitable Contribution | ||
Income Tax Contingency [Line Items] | ||
Federal operating loss carryforwards | 100,000 | |
State Credit | ||
Income Tax Contingency [Line Items] | ||
Federal operating loss carryforwards | 800,000 | |
U.S. Federal or State Income Tax | ||
Income Tax Contingency [Line Items] | ||
Income tax expense | $ 0 | |
State | ||
Income Tax Contingency [Line Items] | ||
Corporate tax rate | 4.00% | |
State | Tax Years 2017 and Beyond | ||
Income Tax Contingency [Line Items] | ||
Corporate tax rate | 3.00% |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Company's Deferred Income Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred income tax assets | ||
Tax loss carryforwards | $ 121,953 | $ 86,600 |
Contribution carryforwards | 24 | 27 |
Tax credits | 15,212 | 12,719 |
Start-up costs & other intangibles | 5,984 | 5,661 |
Share-based compensation | 7,161 | 3,315 |
Deferred revenue | 4,033 | 4,049 |
Other assets | 566 | 350 |
Total net deferred income taxes, non-current | 154,933 | 112,721 |
Less valuation allowance | $ (154,933) | $ (112,721) |
Income Taxes - Summary of Chang
Income Taxes - Summary of Changes in Deferred Tax Valuation Allowance (Details) - Valuation Allowance of Deferred Tax Assets - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Valuation And Qualifying Accounts Disclosure [Line Items] | |||
Balance at beginning of year | $ 112,721 | $ 76,286 | $ 52,858 |
Charges to costs and expenses | 42,212 | 36,435 | 23,428 |
Balance at end of year | $ 154,933 | $ 112,721 | $ 76,286 |
Income Taxes - Difference Betwe
Income Taxes - Difference Between Actual Income Tax Expense (Benefit) and Statutory Federal Income Tax Rate (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Difference between actual income tax expense (benefit) and statutory federal income tax rate | |||
United States federal tax at statutory rate | $ (40,107) | $ (30,978) | $ (20,961) |
State taxes (net of federal benefit) | (1,895) | (1,593) | (1,239) |
Nondeductible expenses | 1,196 | 1,380 | 890 |
Credits | (2,493) | (4,959) | (3,329) |
Adjustment for state rate change | 1,142 | 722 | 1,249 |
Other, net | (55) | (1,007) | (38) |
Change in valuation allowance | $ 42,212 | $ 36,435 | $ 23,428 |
United States federal tax at statutory rate, percentage | 34.00% | 34.00% | 34.00% |
State taxes (net of federal benefit), percentage | 2.00% | 2.00% | 2.00% |
Nondeductible expenses, percentage | (1.00%) | (1.00%) | (1.00%) |
Credits, percentage | 2.00% | 5.00% | 5.00% |
Adjustment for state rate change | (1.00%) | (1.00%) | (2.00%) |
Other, net, percentage | (0.00%) | 1.00% | (0.00%) |
Change in valuation allowance, percentage | (36.00%) | (40.00%) | (38.00%) |
Provision for income taxes, percentage | 0.00% | 0.00% | 0.00% |
Net Loss Per Share - Antidiluti
Net Loss Per Share - Antidilutive Securities Excluded from Computation of Diluted Weighted Average Shares Outstanding (Details) - shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding | 3,658,019 | 3,043,158 | 2,742,476 |
Warrants Outstanding | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding | 94,912 | 132,464 | 330,585 |
Stock Options Outstanding | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding | 3,560,102 | 2,910,694 | 2,411,891 |
Restricted Stock Units | |||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding | 3,005 |
Selected Quarterly Data - Summa
Selected Quarterly Data - Summary of Selected Quarterly Data (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenue | |||||||||||
Contract research | $ 3,606 | $ 3,972 | $ 3,420 | $ 2,679 | $ 4,704 | $ 2,497 | $ 3,171 | $ 2,076 | $ 13,677 | $ 12,448 | $ 9,609 |
License | 4,339 | 10,000 | 4,339 | 10,000 | 4,339 | ||||||
Supply | 1,090 | 1,883 | 1,887 | 4,860 | 1,268 | ||||||
Total revenue | 7,945 | 3,972 | 3,420 | 2,679 | 5,794 | 2,497 | 5,054 | 13,963 | 18,016 | 27,308 | 15,216 |
Operating expenses | |||||||||||
Research and development | 21,043 | 21,096 | 16,018 | 23,529 | 20,018 | 23,541 | 23,676 | 26,118 | 81,686 | 93,353 | 62,539 |
General and administrative | 18,205 | 15,021 | 11,988 | 8,324 | 6,641 | 5,848 | 5,732 | 4,650 | 53,538 | 22,871 | 12,077 |
Loss from operations | (31,303) | (32,145) | (24,586) | (29,174) | (20,865) | (26,892) | (24,354) | (16,805) | (117,208) | (88,916) | (59,400) |
Interest income | 145 | 128 | 104 | 98 | 5 | 2 | 2 | 475 | 9 | 134 | |
Interest expense | (280) | (295) | (323) | (330) | (296) | (679) | (617) | (614) | (1,228) | (2,206) | (2,383) |
Net loss | $ (31,438) | $ (32,312) | $ (24,805) | $ (29,406) | $ (21,156) | $ (27,571) | $ (24,969) | $ (17,417) | $ (117,961) | $ (91,113) | $ (61,649) |
Net loss per share - basic and diluted | $ (0.60) | $ (0.62) | $ (0.51) | $ (0.61) | $ (0.48) | $ (0.63) | $ (0.57) | $ (0.41) | $ (2.34) | $ (2.09) | $ (1.81) |
Shares used in calculating basic and diluted net loss per share | 52,389,000 | 52,073,000 | 48,898,000 | 47,853,000 | 43,976,000 | 43,911,000 | 43,686,000 | 42,671,000 | 50,313,614 | 43,565,518 | 34,130,901 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Details) $ in Millions | 1 Months Ended | |
Feb. 28, 2017USD ($)Employee | Dec. 31, 2016Employee | |
Subsequent Event [Line Items] | ||
Number of employees in workforce | 136 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Workforce reduction percentage | 67.00% | |
Number of employees in workforce | 45 | |
One-time Termination Benefits | Subsequent Event | ||
Subsequent Event [Line Items] | ||
Expected aggregate charge | $ | $ 3.5 |