Organization and Business Activities | 1. Organization and Business Activities Nabriva Therapeutics plc (“Nabriva Ireland”), together with its 98.6% owned and consolidated Austrian subsidiary, Nabriva Therapeutics AG (“Nabriva AG”), and 100% owned and consolidated U.S. subsidiary Nabriva Therapeutics US, Inc. and 100% owned and consolidated Irish subsidiary Nabriva Therapeutics Ireland DAC, (collectively, “Nabriva”, the “Nabriva Group” or the “Company”) is a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics. The Company’s headquarters are located at 25-28 North Wall Quay, Dublin, Ireland. On March 1, 2017, Nabriva Ireland was incorporated in Ireland under the name Hyacintho 2 plc, and was renamed to Nabriva Therapeutics plc on April 10, 2017, in order to effectuate the change of the jurisdiction of incorporation of the ultimate parent company of the Nabriva Group from Austria to Ireland. Nabriva Ireland replaced Nabriva AG as the ultimate parent company on June 23, 2017, following the conclusion of a tender offer (the “Exchange Offer”) in which holders of 98.5% of the outstanding share capital of Nabriva AG exchanged their holdings for ordinary shares, $0.01 nominal value per share, of Nabriva Ireland (the “Redomiciliation Transaction”). The ordinary shares of Nabriva Ireland were issued on a one-for-ten basis to the holders of the Nabriva AG common shares (“Nabriva AG common shares”) and on a one-for-one basis to the holders of the Nabriva AG American Depositary Shares (“Nabriva AG ADSs”) participating in the Exchange Offer. On June 26, 2017, the ordinary shares of Nabriva Ireland began trading on the NASDAQ Global Market under the symbol “NBRV,” the same symbol under which the American Depositary Shares of Nabriva AG were previously traded. This transaction was accounted for as a merger between entities under common control; accordingly, the historical financial statements of Nabriva AG for periods prior to this transaction are considered to be the historical financial statements of Nabriva Ireland. As of June 30, 2017, 98.6% of Nabriva AG share capital had been exchanged for ordinary shares of Nabriva Ireland. The Company currently expects to issue additional ordinary shares of Nabriva Ireland in exchange for the remaining 1.4% of Nabriva AG’s outstanding share capital in the third quarter of 2017. Nabriva AG was incorporated in Austria as a spin-off from Sandoz GmbH in October 2005 and commenced operations in February 2006. Nabriva Therapeutics US, Inc. was founded and began operations in the United States in August 2014. In February 2017, the Company purchased all shares issued in the capital of Hyacintho DAC, a designated activity company incorporated by a nominee company in December 2016 and renamed the company to Nabriva Therapeutics Ireland DAC on April 10, 2017. Throughout these Notes to the Unaudited Consolidated Financial Statements, unless the context requires otherwise, all references to “Nabriva,” “the Nabriva Group,” “the Company,” or similar terms on or prior to June 23, 2017 (the effective date of the Redomiciliation Transaction), refer to our predecessor, Nabriva AG, together with its subsidiaries. Certain share and per share amounts have been retrospectively adjusted to reflect the Exchange Offer and the Redomiciliation Transaction. Liquidity As of December 31, 2016, the Company adopted the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40, Presentation of Financial Statements - Going Concern (“ASC 205-40”), which requires management to assess the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. This standard requires management to 1) identify and disclose if there are initial conditions indicating substantial doubt about the Company’s ability to continue as a going concern within one year of the issuance date of the financial statements, 2) disclose the principal conditions that gave rise to substantial doubt, 3) disclose management’s evaluation of the significance of those conditions in relation to the Company’s ability to meet its obligations and 4) disclose management’s plans that are intended to mitigate the adverse conditions. In accordance with the accounting standard, when considering management’s plans to mitigate the conditions giving rise to substantial doubt, management can only consider those plans which are probable to be successfully implemented. As disclosed in its Annual Report on Form 10-K for the year ended December 31, 2016, the Company’s projected expenditures may deplete current cash, cash equivalents and investments in 2017 and 2018. As of June 30, 2017, management has further assessed this risk and, in accordance with the requirements of ASC 205-40, determined that there are conditions indicating that there is substantial doubt about the Company’s ability to continue as a going concern within one year of the issuance date of these interim consolidated financial statements. Since its inception, the Company has incurred net losses and generated negative cash flows from its operations. To date, it has financed its operations through the sale of equity securities, including its initial public offering of Nabriva AG ADSs and private placements of its Nabriva AG common shares, convertible debt financings and research and development support from governmental grants and loans. As of June 30, 2017, the Company had cash and cash equivalents and short-term investments of $53.2 million. The Company anticipates that its expenses will increase substantially as it continues the development of and potentially seeks marketing approval for lefamulin and, possibly, other product candidates and continues its research activities. The Company’s expenses will increase if it suffers any delays in its Phase 3 clinical program for lefamulin for the treatment of community-acquired bacterial pneumonia (“ CABP”), including delays in enrollment of patients. If the Company obtains marketing approval for lefamulin or any other product candidate that it develops, it expects to incur significant commercialization expenses related to product sales, marketing, distribution and manufacturing. Furthermore, the Company expects to incur additional costs associated with operating as a public company. The Company has developed plans to mitigate this risk, which primarily consist of raising additional capital through a combination of equity or debt financings, new collaborations, and reducing cash expenditures. The Company currently expects to seek funding in future periods. While the Company has raised capital in the past, the ability to raise capital in future periods is not considered probable, as defined under the accounting standards. As such, under the requirements of ASC 205-40, management may not consider the potential for future capital raises in their assessment of the Company’s ability to meet its obligations for the next twelve months. If the Company is not able to secure adequate additional funding, the Company plans to make reductions in spending. This may include extending payment terms with suppliers, liquidating assets, and suspending or curtailing planned programs. The Company may also have to delay, reduce the scope of, suspend or eliminate one or more research and development programs or its commercialization efforts. The ability to reduce spending under this plan, at a level that mitigates the factors described above, is not considered probable, as defined in the accounting standards; as such, under the requirements of ASC 205-40, the full extent to which management may extend the Company’s funds through these actions may not be considered in management’s assessment of the Company’s ability to continue as a going concern for the next twelve months. As a result, in accordance with the requirements of ASC 205-40, management has concluded that it is required to disclose that substantial doubt exists about the Company’s ability to continue as a going concern for one year from the date these financial statements are issued. While management has plans in place to mitigate these actions, they are not considered probable, as defined in the accounting standards, and a failure to raise the additional funding or to effectively implement cost reductions could harm the Company’s business, results of operations and future prospects. The interim consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Based on current projections, the company anticipates availability of top-line clinical data from LEAP 1, its first Phase 3 clinical trial of lefamulin for CABP, in September of 2017. In addition, the Company expects to complete patient enrollment for LEAP 2, its second Phase 3 clinical trial of lefamulin for CABP, in the fourth quarter of 2017 and anticipates availability of top-line data for LEAP 2 in the first quarter of 2018. |