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Nabriva Therapeutics Reports Second Quarter 2022 Financial Results and Provides a Corporate Update

05.08.2022
  • Net Product Sales of $8.7M Grew 25% versus Q2 2021
  • SIVEXTRO Prescription Demand Grew 28% versus Q2 2021

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, 2022 and provided a corporate update.

“We continued to accelerate our commercial growth through improved sales execution in the second quarter of 2022. We are seeing significant early success from our increased focus on SIVEXTRO highlighted by the 28% growth in SIVEXTRO prescription demand versus the second quarter of 2021 and a corresponding 25% growth in net product sales during the same period. Our increased focus on and expansion of the targeted call universe for SIVEXTRO has driven our commercial performance by more than doubling our reach to our called-on prescriber targets. The acceleration of SIVEXTRO revenues continues to have a positive impact on our operating leverage.”

Mr. Schroeder added, “We are also excited to expand the presence of XENLETA outside the United States through our distribution agreement with Er-Kim Pharmaceuticals. Er-Kim’s local expertise and proven track record provides an excellent opportunity to bring XENLETA to patients in need in the territory and potentially create additional value with XENLETA.”

CORPORATE AND DEVELOPMENT UPDATES

  • On April 11, 2022, we announced that the first patient in our Phase 1 clinical trial of XENLETA for the treatment of resistant bacterial infections in patients with Cystic Fibrosis was randomized and dosed. The Phase 1 trial is an open-label, randomized, crossover study to assess the safety and pharmacokinetics following single doses of oral and intravenous XENLETA in adult patients with cystic fibrosis.
  • On May 5, 2022, we announced that we signed an agreement to officially extend our SIVEXTRO Distribution and Promotion Agreement with Merck through at least December 2026.
  • On July 6, 2022, we announced that we were granted a six-month extension by NASDAQ until January 2, 2023, to gain compliance with the $1.00 minimum bid price requirement.On July 18, 2022, we announced our entry into a distribution agreement for XENLETA with Er-Kim Pharmaceuticals pursuant to which Er-Kim licensed from us the rights to distribute XENLETA in the following countries: Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia, and Slovenia. Er-Kim also may distribute XENLETA to an additional five countries through a Named Patient Usage (NPU) program. Nabriva will be the exclusive supplier of XENLETA to Er-Kim.

FINANCIAL RESULTS

Three Months Ended June 30, 2022 and 2021

  • Revenues for the three months ended June 30, 2022 were $9.2 million compared to $8.2 million for the three months ended June 30, 2021. The $1.0 million increase was primarily due to a $1.6 million increase in SIVEXTRO product revenue, net and a $0.1 million increase in XENLETA product revenue, net, offset by a $0.7 million decrease in collaboration revenues.
  • Cost of revenues for the three months ended June 30, 2022 was $4.5 million compared to $3.6 million for the three months ended June 30, 2021. The $0.8 million increase was primarily due to SIVEXTRO inventory purchases. Cost of revenues for XENLETA primarily represents direct and indirect manufacturing costs, while cost of revenues for SIVEXTRO represent the actual purchase cost for the finished product from Merck. For the three months ended June 30, 2022 and 2021, cost of revenues include $37 thousand and $0.2 million, respectively, of a non-cash reserve adjustment for excess and obsolete XENLETA inventory due to timing of expiring inventory.
  • Research and development expenses for the three months ended June 30, 2022 were $4.1 million compared to $3.2 million for the three months ended June 30, 2021, which represented a 30% increase. The $0.9 million increase was primarily due to a $0.1 million increase in travel expenses, a $0.1 million increase in staff costs, and a $0.7 million increase in research materials and purchased services driven by our Phase 1 cystic fibrosis trial of XENLETA.
  • Selling, general and administrative expenses for the three months ended June 30, 2022 were $11.0 million compared to $12.9 million for the three months ended June 30, 2021, which represented a 14% decrease. The $1.8 million decrease was primarily due to a $2.1 million decrease in advisory and external consultancy expenses primarily related to commercialization activities, offset by a $0.1 million increase in travel expenses, and a $0.2 million increase in infrastructure costs.
  • Net loss decreased by $0.7 million from a $11.8 million net loss for the three months ended June 30, 2021 to a $11.1 million net loss for the three months ended June 30, 2022.

Six Months Ended June 30, 2022 and 2021

  • Revenues for the six months ended June 30, 2022 were $17.2 million compared to $10.8 million for the six months ended June 30, 2021. The $6.4 million increase was primarily due to a $8.8 million increase in SIVEXTRO product revenue, net for the six months ended June 30, 2022, partly offset by a $2.1 million decrease in collaboration revenues and a $0.2 million decrease in XENLETA product revenue, net.
  • Cost of revenues for the six months ended June 30, 2022 was $7.8 million compared to $3.7 million for the six months ended June 30, 2021. The $4.1 million increase was primarily due to SIVEXTRO cost, which were not incurred prior to the launch of our own SIVEXTRO National Drug Code on April 12, 2021. Cost of revenues for XENLETA primarily represents direct and indirect manufacturing costs, while cost of revenues for SIVEXTRO represent the actual purchase cost for the finished product from Merck. For the six months ended June 30, 2022 and 2021, cost of revenues include $0.1 million and $0.2 million, respectively, of a non-cash reserve adjustment for excess and obsolete XENLETA inventory due to timing of expiring inventory.
  • Research and development expenses for the six months ended June 30, 2022 were $7.6 million compared to $7.0 million for the six months ended June 30, 2021, which represented an 8% increase. The $0.6 million increase was primarily due to a $0.5 million increase in research materials driven by our Phase 1 cystic fibrosis trial of XENLETA and purchased services, and a $0.1 million increase in travel expenses.
  • Selling, general and administrative expenses for the six months ended June 30, 2022 were $23.7 million compared to $24.9 million for the six months ended June 30, 2021, which represented a 5% decrease. The $1.2 million decrease was primarily due to a $2.1 million decrease in advisory and external consultancy expenses primarily related to commercialization activities, a $0.8 million increase in staff costs, and a $0.1 million increase in travel expenses.
  • Net loss decreased by $2.8 million from a $25.7 million net loss for the six months ended June 30, 2021, to a $22.9 million net loss for the six months ended June 30, 2022.
  • As of June 30, 2022, Nabriva had $20.2 million in cash, cash equivalents and restricted cash. Based on its current operating plans, Nabriva expects that its existing cash resources will be sufficient to enable it to fund its operating expenses, debt service obligations and capital expenditure requirements substantially through the fourth quarter of 2022.

About Nabriva Therapeutics plc

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva 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. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis.

About SIVEXTRO

SIVEXTRO (tedizolid phosphate) was approved by the U.S. Food and Drug Administration in 2014. It is indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), and Enterococcus faecalis. To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat ABSSSI that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

About XENLETA

XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA included diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more information, please visit www.XENLETA.com.

CONTACT:

For Investors and Media
Kim Anderson
Nabriva Therapeutics plc
ir@nabriva.com