Nabriva Therapeutics (NBRV): Q3 2021 Financial Results

By Amit Chowdhry ● Nov 10, 2021
  • Nabriva Therapeutics PLC (NASDAQ: NBRV) has announced its Q3 2021 financial results. These are the details.

Nabriva Therapeutics PLC (NASDAQ: NBRV) – a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections – has announced its Q3 2021 financial results. These are the highlights:

Corporate Updates:

— On August 4, 2021, Nabriva renegotiated terms of its manufacturing agreement with Hovione Limited, the company’s contract manufacturer for XENLETA. Under the renegotiated terms, Nabriva extended the agreement to manufacture XENLETA until November 2030. The initial agreement was set to expire in 2025

— On September 8, 2021, Nabriva announced the approval of XENLETA in Taiwan for the treatment of adults with community-acquired pneumonia

— On September 9, 2021, Nabriva announced an agreement with Vizient Health to make XENLETA available on their national hospital network formulary

— On September 24, 2021, Nabriva entered into an agreement with Lincoln Park Capital Fund, LLC for an Equity Line of Credit facility to augment capital availability

— On October 1, 2021, Nabriva announced the appointment of Dr. Christine Guico-Pabia as Chief Medical Officer

— On October 4, 2021, Nabriva published the first data demonstrating the potent anti-inflammatory properties of XENLETA. And the nonclinical study, entitled “Anti-inflammatory activity of lefamulin versus azithromycin and dexamethasone in vivo and in vitro in a lipopolysaccharide-induced lung neutrophilia mouse model,” was published in the peer-reviewed journal, PLOS ONE.

Financial Results — Three Months Ended September 30, 2021 and 2020

— Revenues for the three months ended September 30, 2021 were $8.9 million compared to $1.3 million for the three months ended September 30, 2020. The $7.6 million increase was primarily due to an increase in net product revenue driven by SIVEXTRO sales.

— Cost of revenues for the three months ended September 30, 2021, were $4.2 million compared to $25,000 for the three months ended September 30, 2020. The $4.2 million increase was primarily due to the launch of the SIVEXTRO National Drug Code (NDC) on April 12, 2021 when Nabriva started recognizing SIVEXTRO sales as revenue and the related cost of product sales in its results of operations.

— Research and development expenses for the three months ended September 30, 2021 were $3.2 million compared to $3.5 million for the three months ended September 30, 2020. The $0.3 million decrease was primarily due to a $0.2 million decrease in stock-based compensation expense and a $0.3 million decrease in staff costs, partly offset by a $0.2 million increase in research materials and purchased services.

— Selling, general and administrative expenses for the three months ended September 30, 2021 were $12.3 million compared to $11.0 million for the three months ended September 30, 2020. The $1.3 million increase was primarily due to the relaunch of our community-based sales force for both XENLETA and SIVEXTRO.

— Net loss decreased $2.3 million from a $13.0 million net loss for the three months ended September 30, 2020 to a $10.7 million net loss for the three months ended September 30, 2021.

9 Months Ended September 30, 2021 and 2020

— Revenues for the nine months ended September 30, 2021 were $19.6 million compared to $2.6 million for the nine months ended September 30, 2020. The $17.1 million increase was primarily driven by the launch of our own SIVEXTRO NDC, as well as an increase of $2.6 million of collaboration revenues, which primarily included revenue related to our China region license agreement.

— Cost of revenues for the nine months ended September 30, 2021 were $7.9 million compared to $0.4 million for the nine months ended September 30, 2020. The $7.5 million increase was primarily due to the launch of Nabriva’s own SIVEXTRO NDC on April 12, 2021 when Nabriva started recognizing SIVEXTRO sales as revenue and the related cost of product sales in its results of operations.

— Research and development expenses for the nine months ended September 30, 2021 were $10.2 million compared to $12.3 million for the nine months ended September 30, 2020. The $2.0 million decrease was primarily due to a decrease in staff costs.

— Selling, general and administrative expense for the nine months ended September 30, 2021 were $37.2 million compared to $37.8 million for the nine months ended September 30, 2020. The $0.6 million decrease was primarily driven by decreased staff costs.

— Net loss decreased $15.3 million from a $51.7 million net loss for the nine months ended September 30, 2020 to a $36.4 million net loss for the nine months ended September 30, 2021.

— As of September 30, 2021, the company had cash and cash equivalents of $52.0 million. Based on its current operating plans, the company 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 second quarter of 2022.

KEY QUOTES:

“We saw our commercial business continue to gain momentum in the third quarter, with total revenues growing to $8.9 million. We experienced a significant step-up in SIVEXTRO performance during the quarter, with double-digit prescription growth building on the trend we saw in the second quarter of 2021. In addition, by driving continued operating efficiency, we were able to extend our cash runway by an additional quarter to substantially through the second quarter of 2022.”

“Recent trends in the oral antibiotic market have been encouraging. We have started to see a rebound with current industry-wide volumes of antibiotic use approaching 2019 levels. Our focus remains on – establishing the benefits of XENLETA with healthcare providers (HCPs) for the community-acquired bacterial pneumonia (CABP) season over the coming quarters. We launched our in-house promotion initiative with additional remote representatives promoting to targeted incremental opportunities for both XENLETA and SIVEXTRO. We also entered into a partnership with Vizient Health that we believe will help expand access to XENLETA in the hospital setting through their pharmacy network and create increased opportunities for formulary inclusion and for HCPs to prescribe XENLETA in the inpatient and outpatient setting.”

— Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.