 -SIVEXTRO adds revenue generating product creating additional scale and synergies- -Relaunch of XENLETA and SIVEXTRO planned with targeted in-person promotion- -Conference call today at 4:30 p.m. Eastern Time-DUBLIN, Ireland, Aug. 06, 2020 GLOBE NEWSWIRE -- Nabriva Therapeutics plc NASDAQ: NBRV, a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced its financial results for the three months ended June 30, 2020 and provided a corporate update.We have been actively building the foundation for relaunching our commercial efforts in the community. Nabriva now has an experienced contract sales partner and the opportunity to promote and distribute an important new revenue-generating product in SIVEXTRO. Adding SIVEXTRO to our portfolio is an important component of our strategy to actively pursue business development and licensing opportunities that have a highly complementary customer base and leverage Nabrivas capabilities, said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. We recently secured an agreement with Amplity Health, a leading pharmaceutical contract commercial organization, to provide Nabriva the ability to build a flexible and efficient sales infrastructure to leverage brand awareness for both XENLETA and SIVEXTRO. We believe Nabriva now has a solid foundation in place to educate health care providers about the benefits of these two important anti-infective treatment options for their patients. Our managed care presence continues to strengthen in the U.S. and XENLETA is now accessible to more than 225 million covered lives. This, coupled with our partnership with WEP Clinical and recent approvals for XENLETA in the European Union and Canada, have enhanced our ability to provide access for patients despite the challenges presented by the ongoing global pandemic.CORPORATE AND DEVELOPMENT UPDATES On July 28, 2020, Nabriva announced that the European Commission EC approved the marketing authorization application for XENLETA lefamulin for the treatment of community-acquired pneumonia CAP in adults in the European Union following a review by the European Medicines Agency. On July 16, 2020, Nabriva announced that Sunovion Pharmaceuticals Canada Inc., received approval from Health Canada to market oral and intravenous IV formulations of XENLETA for the treatment of community-acquired pneumonia in adults in Canada. Nabriva entered into a license and commercialization agreement in March 2019 with Sunovion Pharmaceuticals Canada Inc. for XENLETA in Canada. On July 15, 2020, Nabriva announced that it entered into an exclusive agreement with subsidiaries of Merck Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO tedizolid phosphate in the United States and certain of its territories. SIVEXTRO is an oxazolidinone-class antibacterial. In addition, Nabriva engaged Amplity Health, a leading pharmaceutical contract commercial organization, to provide community-based commercial and sales services for SIVEXTRO and XENLETA in the United States. On June 30, 2020, Nabriva announced that it had signed an exclusive agreement with WEP Clinical WEP, a specialist pharmaceutical services company, to supply XENLETA on a named patient or expanded access basis in certain countries outside of the U.S., China and Canada. The Named Patient Program NPP is designed to ensure that physicians, contingent on meeting the necessary eligibility criteria and receiving approval, can request IV or oral XENLETA on behalf of patients who live in certain countries where it is not yet available and have an unmet medical need. On June 19, 2020, Nabriva received a Complete Response Letter CRL from the U.S. Food and Drug Administration for the New Drug Application NDA resubmission seeking marketing approval of CONTEPOTM fosfomycin for injection for the treatment of complicated urinary tract infections cUTIs, including acute pyelonephritis. Although Nabrivas European contract manufacturing partners were prepared for regulatory authority inspections, the CRL cites observations at its manufacturing partners that could not be resolved due to FDAs inability to conduct onsite inspections because of travel restrictions caused by the COVID-19 pandemic. In general, previously identified product quality and facility inspection related observations at its contract manufacturing partners are required to be satisfactorily resolved before the NDA may be approved. The FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of CONTEPO in the CRL. Nabriva plans to request a Type A meeting with the FDA to discuss its plans for completing foreign facility inspections and the appropriate next steps to refile the NDA. CONTEPO has been granted Qualified Infectious Disease Product QIDP and Fast Track designations by the FDA for the treatment of serious infections, including cUTIs. On May 29, 2020, Nabriva announced that it entered into a definitive agreement with several healthcare-focused institutional investors, including Fidelity Management Research Company, LLC, to issue and sell ordinary shares and warrants in a registered direct offering priced at-the-market under Nasdaq rules for aggregate gross proceeds of 38.0 million before deducting placement agent fees and other offering expenses payable by Nabriva. On April 7, 2020, Nabriva announced it was restructuring its hospital-based commercial sales force and transitioning to a community-based sales force. The restructuring aligns the capabilities of the Companys sales force with its strategic refocus for promoting XENLETA to community health care professionals, the excellent managed care coverage it has secured and its business development strategy to in-license additional community products, resulting in a substantial reduction in expenditures. In the second quarter, Nabriva also reduced commercial, medical affairs and administrative expenses. On April 9, 2020, Nabriva received confirmation from the Centers for Medicare and Medicaid Services CMS of a preliminary decision to assign permanent product-specific Healthcare Common Procedure Coding System HCPCS J-code for XENLETA 150 mg injection. The new billing code, J0691 Injection, became effective July 1, 2020, replaced the C Code, C9054 and enables healthcare providers to list physician-administered drugs on claim forms submitted to CMS to receive proper reimbursement for Medicare-eligible patients. On April 29, 2020, Nabriva received written notice from Nasdaq indicating that, based on the closing bid for the last 30 consecutive business days, the Company was not in compliance with the 1.00 minimum bid price Bid Price Rule requirement for continued listing on The Nasdaq Global Select Market. The Notice does not result in the immediate delisting of the Companys ordinary shares from The Nasdaq Global Select Market. Nabriva will have until December 28, 2020 to regain compliance with the Bid Price Rule. To regain compliance, the closing bid price of Nabrivas ordinary shares must be at least 1.00 per share for a minimum of ten consecutive business days on or before December 28, 2020. At its July 29, 2020 Annual General Meeting, Nabrivas shareholders approved a reverse stock split i.e., a consolidation of share capital under Irish law, subject to and conditional upon the board of directors determining, in its sole discretion, that a reverse stock split is necessary for the Company to comply with the Bid Price Rule, whereby every 10 ordinary shares of 0.01 nominal value each in the authorized and unissued and authorized and issued share capital of the Company be consolidated into 1 ordinary share of 0.10 nominal value each, and the subsequent reduction in the nominal value of the ordinary shares in the authorized and unissued and authorized and issued share capital of the Company from 0.10 each to 0.01 each. Nabrivas board of directors is evaluating whether a reverse stock split is necessary. FINANCIAL RESULTS Three Months Ended June 30, 2019 and 2020 Revenues were 0.5 million for the three months ended June 30, 2019 and 0.5 million for the three months ended June 30, 2020, primarily due to grant revenues. For the three months ended June 30, 2020 we recorded 0.1 million of product revenue, net of gross-to-net accruals. In addition, we recorded a 0.3 million returns reserve adjustment for slow moving inventory, representing 50 of XENLETA IV inventory held at our Specialty Distributors, partly offset by a favorable 0.2 million gross-to-net adjustment, resulting in 48 thousand of negative product revenue, net for the three months ended June 30, 2020. Research and development expenses decreased by 1.6 million from 8.1 million for the three months ended June 30, 2019 to 6.5 million for the three months ended June 30, 2020. The decrease was primarily due to a 0.9 million decrease in staff costs, a 0.5 million decrease in research consulting fees, and a 0.1 million decrease in travel costs. Selling, general and administrative expense decreased by 5.3 million from 13.4 million for the three months ended June 30, 2019 to 8.1 million for the three months ended June 30, 2020. The decrease was primarily due to a 4.5 million decrease in advisory and external consultancy expenses primarily related to pre-commercialization activities and professional service fees in 2019, a 0.5 million decrease in staff costs due to the termination of employees, a 0.4 million decrease in travel expenses and a 0.4 million decrease in infrastructure costs, partly offset by a 0.4 million increase in legal fees. 