Nabriva Therapeutics Reports 2018 Financial Results and Recent Corporate Highlights

Two PDUFA dates in 2019: April 30, 2019 for CONTEPO and August 19, 2019 for Lefamulin. Company preparing for potential commercialization of two first-in-class antibiotics, Lefamulin (IV and Oral) and CONTEPO (IV) in the United States in 2019

Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, today announced its financial results for the year ended December 31, 2018 and recent corporate highlights.

“2018 was a year of tremendous progress for Nabriva. We acquired Zavante, submitted New Drug Applications (NDAs) for CONTEPO for the treatment of complicated-urinary tract infections (cUTIs), including acute pyelonephritis (AP), and for both intravenous and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia (CABP),” said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. “We look forward to working with the U.S. Food and Drug Administration (FDA) during their reviews of CONTEPO and lefamulin and potentially bringing two first-in-class antibiotics to patients in the United States with serious infections. We remain focused on commercializing both CONTEPO and lefamulin with our own targeted sales and marketing organizations in the U.S., while continuing to identify partners to advance our efforts to develop and commercialize lefamulin outside the U.S.”

RECENT CORPORATE AND DEVELOPMENT HIGHLIGHTS

RESEARCH AND DEVELOPMENT

Submitted NDAs to the FDA in the forth quarter of 2018 for:

  • Intravenous (IV) CONTEPO for the treatment of cUTIs, including AP. CONTEPO has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of several serious infections, including cUTI, which enables Priority Review of the NDA. In January 2019, Nabriva Therapeutics announced that the FDA accepted the NDA and granted a Priority Review for CONTEPO, with a Prescription Drug User Fee Act (PDUFA) action date for completion of the FDA’s review of April 30, 2019.
  • Oral and IV formulations of lefamulin, a potentially first-in-class, pleuromutilin antibiotic, for the treatment of CABP. Both formulations of lefamulin were granted QIDP and Fast Track designation by the FDA, enabling potential Priority Review of the NDAs by the FDA. In February 2019, Nabriva Therapeutics announced the FDA accepted the NDAs and granted Priority Review for lefamulin with a PDUFA action date for completion of the FDA’s review of August 19, 2019.

Announced positive topline results from the Lefamulin Evaluation Against Pneumonia (LEAP) 2 clinical trial, the second of two global, pivotal Phase 3 clinical trials evaluating the safety and efficacy of oral lefamulin for the treatment of CABP. In this trial, lefamulin met the FDA and EMA primary endpoints and was shown to be generally well-tolerated.

CORPORATE

In January, 2019, hosted an Investor/Analyst Event featuring discussions with leading clinicians and researchers who addressed current and potential new treatments for CABP and cUTIs. Nabriva management also discussed the commercial strategy for the Company’s investigational antibiotics, lefamulin and CONTEPO. Presentations from the event can be found under the "Events and Presentations" tab http://investors.nabriva.com until April 15, 2019

Business Development

  • Completed the acquisition of Zavante Therapeutics Inc. (“Zavante”) in July 2018 for upfront consideration of approximately 8.2 million of Nabriva Therapeutics’ ordinary shares (which includes an indemnity holdback) to Zavante’s former stockholders.
  • In addition, Zavante’s former stockholders are eligible to receive up to $97.5 million upon the achievement of specified regulatory and commercial milestones, which subject to specified limitations, may be settled in Nabriva Therapeutics’ ordinary shares.

Bolstered our Management Team

  • Appointed Ted Schroeder, former Chief Executive Officer of Zavante, as Chief Executive Officer of Nabriva Therapeutics who succeeded Dr. Colin Broom. Dr. Broom, remains on the Board of Directors of Nabriva Therapeutics.
  • Appointed Jennifer Schranz, M.D., as Chief Medical Officer to lead clinical development and medical affairs.
  • Named Dr. Steven Gelone President and Chief Operating Officer of Nabriva Therapeutics.

Strengthened our Balance Sheet

  • Closed up to a $75.0 million term loan with Hercules Capital, Inc. in December 2018, $25.0 million of which was funded on the day of closing with up to an additional $45.0 million that is available at Nabriva Therapeutics option, subject to the achievement of certain regulatory and commercial milestones.
  • Completed a public offering of ordinary shares in July 2018. The gross proceeds from the offering were $50.0 million and net proceeds to the Company were $46.1 million, after deducting underwriting discounts and commissions and offering expenses.

Partnering

  • In March 2018, announced the initiation of a license agreement with Sinovant Sciences, an affiliate of Roivant Sciences, pursuant to which it granted Sinovant Sciences a license to develop and commercialize lefamulin in greater China.
  • Received $6.5 million to date from Sinovant Sciences and will be eligible for up to approximately $90.0 million in additional milestone payments tied to the successful completion of certain regulatory and commercial milestones related to lefamulin for CABP, plus an additional $4.0 million in milestone payments if lefamulin is approved for a second indication in China.
  • In addition, Nabriva Therapeutics will be eligible to receive low double-digit royalties on sales upon approval in the covered territories. Sinovant Sciences is solely responsible for all clinical development and regulatory filings necessary to secure approval in the covered territories, as well as commercialization activities.

FULL YEAR 2018 FINANCIAL RESULTS

  • For the year ended December 31, 2018, Nabriva Therapeutics reported a net loss of $114.8 million, or $2.26 per share, which includes a $32.0 million in-process research and development charge associated with the acquisition of Zavante, compared to a net loss of $74.4 million, or $2.49 per share, for the year ended December 31, 2017.
  • Research and development expenses increased by $32.7 million from $49.6 million for the year ended December 31, 2017 to $82.3 million for the year ended December 31, 2018. The increase was primarily due to a $32.0 million in-process research and development charge associated with the acquisition of Zavante, a $6.5 million increase in research consulting fees, a $6.5 million increase associated with the payment of the new drug application fees to the FDA and a $1.9 million increase in staff costs due to the addition of employees, partly offset by a $13.9 million decrease in research materials and purchased services related to the development of lefamulin.
  • General and administrative expense increased by $12.3 million from $29.5 million for the year ended December 31, 2017 to $41.7 million for the year ended December 31, 2018. The increase was primarily due to a $9.6 million increase in staff costs due to the addition of employees, a $2.6 million increase of advisory and external consultancy expenses primarily related to pre-commercialization activities and professional service fees and a $1.0 million increase in other corporate costs, partly offset by a $2.2 million decrease in legal fees.
  • As of December 31, 2018, Nabriva Therapeutics had $102.2 million in cash, cash equivalents and short-term investments compared to $86.9 million as of December 31, 2017. Existing cash resources are expected to fund operations into the second quarter of 2020.

Please refer to the Annual Report on Form 10-K of Nabriva Therapeutics for the fiscal year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, for additional information regarding the Company’s business and financial results.

About Nabriva Therapeutics plc

Nabriva Therapeutics is a biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics has two product candidates that are in late stage development: lefamulin, potentially the first systemic pleuromutilin antibiotic for CABP and CONTEPO (fosfomycin for injection), a potential first-in-class epoxide antibiotic in the United States for complicated urinary tract infections (cUTIs) including acute pyelonephritis (AP). For more information, please visit https://www.nabriva.com.