FORT WASHINGTON, PA — Nabriva Therapeutics plc (NASDAQ: NBRV) announced a business update this week and preliminary, unaudited financial results for the fourth quarter of 2021.
“We made excellent progress in 2021 in spite of the COVID pandemic and are poised for continued growth in 2022,” commented Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. “We had a strong close to 2021 for SIVEXTRO, which contributed to extending our cash runway well into the fourth quarter of 2022 and we continue to propel the product back to historical prescription trends through our promotional efforts.” Mr. Schroeder continued, “while our commercialization efforts for XENLETA have faced significant headwinds due to the global pandemic, we remain focused on maximizing the value of this novel, first-in-class antibacterial agent in the U.S. through our focused commercial investments, and outside the U.S. by expanding our partnerships globally.”
“We have also made significant progress in executing on life-cycle management opportunities for XENLETA with the initiation of a Phase I trial for CF and early-stage work focused on drug-resistant sexually transmitted infections and other unmet medical conditions for this important drug.” Mr. Schroeder added, “we stand ready to resubmit our New Drug Application for CONTEPO and potentially bring this important antibiotic to the U.S. market once COVID-related travel restrictions are lifted and the U.S. Food and Drug Administration (FDA) is able to complete inspections of our manufacturing partners in the European Union.”
In 2021, the Company positioned the growth of it business by:
- Launching Nabriva’s own National Drug Code (NDC) of SIVEXTRO in April 2021
- Reporting positive Phase III trial results for lefamulin in China in May 2021
- Transitioning lefamulin commercial rights in China to Sumitomo Pharmaceuticals in May 2021
- Receiving approval of lefamulin in Taiwan in September 2021
- Contracting with Vizient Health in September 2021 to enhance access for XENLETA
- Publishing data on anti-inflammatory effects of lefamulin in PLOS ONE in November 2021
- Achieving acceptance of their New Drug Application by the National Medical Products Administration (NMPA) in China in November 2021
- Launching a 10-count blister pack or “X Pack” of XENLETA in November 2021 to improve distribution and customer access
In 2022, the Company looks for continued growth through execution on key milestones including:
- Growing SIVEXTRO sales to historical levels by mid-2022
- Pulling through hospital transition of care opportunity for XENLETA with Vizient Health
- Enrolling the first patient in their Phase I CF trial in the first quarter
- Geographic expansion of commercialization and distribution partnerships for lefamulin in the EU and the rest of the world
- Continuing to work with FDA to bring CONTEPO to market in the U.S.
- Assessing other business development opportunities to add to their product portfolio and leverage current infrastructure
Preliminary Financial Results
The company enters 2022 with $47.7 million of cash, cash equivalents and short-term investments as of December 31, 2021 compared to $52.2 million of cash, cash equivalents and short-term investments as of September 30, 2021. As a result of the strong close to 2021 for SIVEXTRO sales, and improved operating efficiencies within the business, their cash balance as of December 31, 2021 is expected to fund their operations, debt service obligations and capital expenditure requirements well into the fourth quarter of 2022. In addition, the Company anticipates reporting that total revenue for the fourth quarter of 2021 grew at a mid-to-high single digit percentage versus third quarter of 2021’s reported total revenue of $8.9 million.
These estimated financial results are preliminary and unaudited, represent management’s estimates as of the date of this press release and are subject to completion of Nabriva’s financial closing procedures. Nabriva’s independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, these estimated financial results.
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