- Revenue increased by 23% to US$317.1M, the highest reported annual sales in the Company’s history.
- Xellia’s novel Premixed Vancomycin in a Ready-to-Use (RTU) bag recently received Qualified Infectious Disease Product (QIDP) designation from the FDA and the Company expects to make a regulatory submission in 2018.
Xellia Pharmaceuticals (‘Xellia’), a specialty pharmaceutical company owned by Novo Holdings A/S, today reported its financial results for the year ending December 31, 2017 and provided an update on its product portfolio. Xellia is focused on providing important anti-infective treatments against serious and often life-threatening infections.
Revenue for 2017 increased by 23% to US$317.1M which is the highest reported sales since the Company was established as an independent business in 2008. Net result more than doubled to US$39.0M compared to US$18.7M in 2016. The strong financial result builds on an increased supply of several key products and was, in particular, driven by continued growth in US sales which accounted for 60% of total revenue in 2017 (up from 54% in 2016).
Xellia also reported progress on the development of its pipeline of value-added anti-infectives. The Company’s Premixed Vancomycin is a novel liquid dosage form of vancomycin in a ready-to-use infusion bag, and was recently granted QIDP designation from the U.S. Food & Drug Administration (FDA). A New Drug Application (NDA) submission for this product to the FDA is anticipated during 2018. The Company is also beginning to expand its U.S. commercial organization as it prepares for the launch of this and other innovative anti-infective drug products.
Carl-Åke Carlsson, Xellia’s CEO said: “Premixed Vancomycin RTU is one of the first products in our pipeline of value-added anti-infectives that we began to develop in 2014. Our pipeline focuses on advancing patient care by aiming to eliminate steps in the compounding process which may reduce medication errors. We continue to work hard to ensure that Premixed Vancomycin RTU and other products from our innovative pipeline become available to healthcare professionals and their patients as soon as possible.”
QIDP designation is granted under the Generating Antibiotic Incentives Now (GAIN) Act in the U.S. and provides certain incentives for the development of antibiotics that include priority review and eligibility for fast-track designation.
Since 2014, Xellia commenced development of a pipeline of innovative anti-infective therapies based on the Company’s core portfolio. To support the commercialization, of these products the Company has significantly expanded its manufacturing capabilities for sterile injectables in the U.S., including the acquisitions of sites at Raleigh, North Carolina and Cleveland, Ohio. Facilities at the Cleveland site have subsequently received substantial upgrades. The Company will continue to make significant investments in its U.S. business during 2018 in preparation for the commercialization of its innovative product pipeline.
Financial Highlights for 2017 (compared to 2016).
Key figures in million USD.
• EBITDA increased 36% to 86.5 (2016: 63.6)
• Operating profit / EBIT increased by 75% to 51.5 (2016: 29.5)
• Net profit more than doubled to 39.0 (2016: 18.7)
• Total assets increased by 21% to 778.1 (2016: 645.2)
• Total number of full-time employees grew by 145 (11%) to 1,497 (2016: 1,352)
For more information, please contact:
Carl-Åke Carlsson, CEO
Tel: +45 32 64 55 00
Instinctif Partners (International media relations)
Eileen Paul / Ashley Tapp / Melanie Toyne-Sewell
Tel: +44 (0) 20 7457 2020