Xellia Pharmaceuticals Reports on Strong 2017 Financial Results & Advances in the Development of its Novel Premixed Vancomyci...
March 21 2018 - 5:00AM
Business Wire
- 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.
- Revenue grew over 23% to 317.1 (2016:
257.4)
- 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)
- Ends -
About Xellia
Xellia Pharmaceuticals is a specialty pharmaceutical company
focused on providing important anti-infective treatments against
serious and often life-threatening bacterial and fungal infections.
With over 100 years of experience Xellia is a leading developer,
manufacturer and trusted supplier of fermented and semi-synthetic
Active Pharmaceutical Ingredients (APIs) and Injectable Finished
Dosage Forms (FDFs) to the pharmaceutical industry. The Company has
growing sales in more than 70 countries to over 500 customers
across the healthcare industry. Headquartered in Copenhagen,
Denmark, Xellia has global facilities including operational and
manufacturing capabilities in Denmark, USA, Hungary and China, and
currently employs around 1,500 people.
Xellia has a portfolio of specialty anti-infectives, and is a
leading supplier of vancomycin and colistimethate sodium (CMS)
which together combat life-threatening, multi-drug resistant
bacterial infections across Gram-positive and Gram-negative
species.
Many of these are last resort antibiotics, often used when all
other treatments have failed. Xellia is also dedicated to providing
new anti-infective treatment options by improving the efficacy and
delivery, and reducing toxic side effects of existing products. The
Company also has early stage R&D programs focused on the
discovery and formulation of new chemical entities effective
against resistant microbes, with novel modes of action.
Since July 2013, Xellia has been wholly owned by Novo Holdings
A/S, the holding company of the Novo Group.
Further information about Xellia can be found at:
www.xellia.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20180321005070/en/
Xellia PharmaceuticalsCarl-Åke Carlsson, CEOTel: +45 32
64 55 00orInstinctif Partners (International media
relations)Eileen Paul / Ashley Tapp / Melanie Toyne-SewellTel:
+44 (0) 20 7457 2020Email: xellia@instinctif.com