Xellia Pharmaceuticals Aps

Ledelsesberetning

Statutory statement regarding data ethics in accordance with section 99d of the Danish Financial Statements Act

Beskrivelse af virksomhedens væsentligste aktiviteter

Business review
Xellia Pharmaceuticals (“Xellia”) is a specialty pharmaceutical company developing, manufacturing, and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections.
Xellia is a global leader in providing anti-infective treatments and other critical care therapies for serious and often life-threatening conditions. Xellia has an extensive history in developing, manufacturing, and commercializing anti-infective products, including Active Pharmaceutical Ingredients (APIs) as well as Finished Dosage Forms (FDF), where the majority are injectable drug products. As an organization, Xellia is committed to providing security and consistency of supply of critical care therapies. Through a global vertically integrated supply chain, the company continuously works to improve supply security through multiple sources of in-house production of its APIs and drug products, and in conjunction through working alongside Xellia’s R&D center. Supplying products to more than 70 countries worldwide and with more than 500 customers internationally, Xellia is the leading supplier of the important anti-infectives vancomycin, daptomycin, bacitracin, and colistimethate sodium (CMS).
Through innovation and with the patient in focus, Xellia is building a pipeline of value-added critical care therapies which aim to enhance patient care by providing convenience and ease of use for healthcare professionals. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with manufacturing, R&D and commercial operations across Europe, Asia, the Middle East and North America. Xellia’s four manufacturing facilities located in; China, Denmark, Hungary, and in the U.S. Xellia operates according to current Good Manufacturing Practice (cGMP), and Xellia’s facilities have been inspected by relevant regulatory health authorities, including the U.S. Food and Drug Administration (FDA).
Xellia operates via two pillars, Global Anti-Infectives (‘GAI’) and US Injectables (‘USI’), which are defined by sales channels. Both businesses are supported by the quality assurance, supply and distribution, and R&D teams. The Global Anti-infective unit includes B2B (business to business) sales in all geographic markets and oversight of the three plants in Denmark, Hungary and China. In addition to supporting current customers, the GAI organization works to introduce the company’s core product portfolio into new markets – where primary focus is on China, the Middle East and Latin America. The US Injectables business encompasses the handling of all sales in the US institutional market and the day-to-day responsibility for US subsidiary production plant. The business unit is focused on the launch and commercialization of Xellia's own branded specialty injectable anti-infective medicines and generic products to the US institutional markets and also overseeing contract manufacturing operations for the US market.
Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of more than 1,700 full-time employees.
Further information about Xellia can be found at:
www.xellia.com

Beskrivelse af usikkerhed ved indregning eller måling

Recognition and measurement uncertainties
The recognition and measurement of items in the Annual Report is not subject to material uncertainties that could significantly impact the Annual Report.

Beskrivelse af udviklingen i virksomhedens aktiviteter og økonomiske forhold

Financial review
The company's income statement for the year ended December 31, 2023, shows a net loss of MDKK 2,384.9, and the balance sheet at December 31, 2023, shows a negative equity of MDKK -597.8.
Investments
In 2023, Xellia invested MDKK 3 in intangible assets and MDKK 134.6 intangible assets mainly to maintain and upgrade current production facilities and to meet compliance requirements.

Omtale af betydningsfulde hændelser, som er indtruffet efter regnskabsårets afslutning

Uncertainties relating to going concern
After recognition of the 2023 loss, the Equity is negative and totals MDKK -597.8, as of December 31, 2023.
The parent company New Xellia Group A/S has issued a Letter of support to which the parent company will provide any support necessary for Xellia Pharmaceuticals ApS to fulfil its obligations until December 31, 2025.
Based on the circumstances described above, the financial statements are prepared by the Management on the basis that Xellia Pharmaceuticals ApS is a going concern.

Beskrivelse af virksomhedens forventede udvikling

Subsequent events
After the balance sheet date, the following significant subsequent events occurred in the period between the end of the financial year and the Board of Directors’ adoption of the annual report.
The parent company, New Xellia Group A/S, and the owner, Novo Holdings A/S, have concluded an amendment to the loan agreement with the lenders to postpone delivery of compliance certificate pursuant to the loan agreement.