Xellia Pharmaceuticals Reports 2022 Business Update and 2023 Outlook

Copenhagen, Denmark, 18 April 2023 - Xellia Pharmaceuticals (‘Xellia’ or the ‘Group’), a specialty pharmaceutical company focusing on providing anti-infective treatments and other critical care therapies for serious and often life-threatening conditions, reports its business update for the year ending December 31, 2022 and outlook for 2023.

2022 Full Year Overview Global Anti-infectives business
Xellia’s aim for 2022 was to expand its Global Anti-infectives (‘GAI’) business, to ensure that it remains the cornerstone manufacturer of key anti-infectives and supplier of choice. During 2022, Xellia identified a series of growth initiatives for its GAI business; expanding its anti-infective products into new geographic markets, spearheading antibiotic stewardship, and supporting the battle of anti-microbial resistance.

Building upon the existing portfolio of anti-infectives, such as vancomycin, daptomycin, and colistimethate sodium; Xellia has taken these established products into multiple new geographic markets – expanding access globally. This has been achievable through collaborations with strategic partners supporting market launches, and also by working with partners to create new innovative formulations and through newly registered indications. Xellia filed a total of 36 applications for its products worldwide during 2022, which are now awaiting approval from respective regulatory authorities.

US Injectables business
The focus for the US Injectables (‘USI’) business has been 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 (CMO) partnerships at Xellia’s Cleveland site.

Of Xellia’s own in-house products, the focus has been on the sale of Xellia’s VANCO READY®, ready-to-use vancomycin drug product. During 2022, Xellia saw significant growth in both sales and customer base. Continuing to expand the institutional customer base and growing penetration with existing customers are key components of the VANCO READY® strategy, and 2022 demonstrated that healthcare providers are showing a preference for premixes as they aid in promoting safe medication administration practices and timeliness to treat patients.

The Cleveland site had a full 2022, including meeting regulatory and customer audits, implementing updates and modifications to the facility, engaging in activities around new strategic partnerships, and in developing its growing workforce. The Company filed an application with the US FDA to allow Xellia’s branded VANCO READY® product to be manufactured at the Cleveland site and at the end of 2022, the site completed the US FDA’s pre-approval and general GMP inspection of its aseptic bag manufacturing line.

Sustainability highlights
Xellia saw great progress in its sustainability programs and activities in 2022, from increased global collaboration on ESG projects to locally driven activities focused on promoting health and safety. Xellia updated its ESG targets in 2022, introducing new targets and expanding the timeframe to 2030. Among which, Xellia introduced a new target to reduce by 40% scope 1 and scope 2 carbon emissions.

Additionally, continued effort in 2022 remained on Xellia’s sustainable manufacturing, supply, and distribution processes of all its products. As part of the AMR Industry Alliance, Xellia continued to work with Medicines for Europe around AMR and value-added medicines to reduce the effect of AMR, furthermore Xellia made progress on the Company’s Sustainability Framework, which ensures a holistic and systemic approach to ESG activities. During the year, Xellia joined the global sustainability organizations Pharmaceutical Supply Chain Initiative (PSCI) and End Drug Shortages Alliance to build on the Company’s commitment to responsible business practices and reaching patients in critical need.

2022 trading and 2023 business outlook
Overall Xellia experienced mixed results, but good overall progress. The USI business remained in investment mode during 2022, incurring costs related to ramping up the Cleveland facility, whilst the GAI business continued to trade profitably. Revenues reached 327.2 MUSD - 8% growth over the prior year - and excluding one-time costs to the business, the Adjusted EBITDA was 61 MUSD (up 36% over 2021). The adjustment made is due to start-up costs related to the Cleveland facility which amounted to 41 MUSD in 2022.

The GAI business performed well with Revenue at an all-time high of 242.8 MUSD, growing 4% over 2021 largely due to capacity expansion for key anti-infective API products and with continued strong profitability despite experiencing inflationary pressure in Europe associated with energy and commodities. The USI business continued to be in investment mode through 2022 as Cleveland drives towards the production of VANCO READY® and other key anti-infective products. However, the USI business did show strong year-on-year Revenue growth of 23% reaching 84.4 MUSD, largely from VANCO READY® and newly launched In-Licensing products....