CSL Limited Annual Report 2022/23 16 2 Our Company Our operating review 1 Constant currency (CC) removes the impact of exchange rate movements, facilitating the comparability of operational performance. For further detail refer to CSL’s Financial Statements for the Full Year ended June 2023 (Directors Report). 2 Eleven months to FY22 pre-CSL ownership and unaudited v eleven months to FY23. CSL Behring Total revenue was US$9,290 million, up 12%1 when compared to the prior comparable period. Immunoglobulin (Ig) product sales of US$4,675 million, increased 21%1 with strong growth recorded across all geographies as global supply recovered strongly. PRIVIGEN® (Immune Globulin Intravenous (Human), 10% Liquid) sales delivered strong growth of 29%1 as demand continues to recover from the pandemic with patient diagnosis and new patient starts steadily increasing. HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 12%1 as patient diagnosis rates continue to improve and new patients emerge. Underlying demand for Ig continues to be strong due to significant patient needs in core indications – namely Primary Immune Deficiency, Secondary Immune Deficiency and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Albumin sales of US$1,109 million, were up 11%1. Sales in China were up strongly as COVID restrictions eased. Solid growth was also recorded in the United States and Europe as supply improved. Haemophilia product sales of US$1,193 million increased 8%1. IDELVION®, CSL Behring’s novel long-acting recombinant factor IX product, achieved strong growth of 13%1 as patient interactions with health care providers increased post COVID. HEMGENIX®, the first and only gene therapy for haemophilia B was successfully launched in the United States. The haemophilia A market continued to be competitive resulting in a modest increase in sales for AFSTYLA®, a novel recombinant factor VIII product, and a decline in sales for plasma-derived products. Specialty product sales of US$1,831 million, up 6%1 led predominately by demand for KCENTRA® and ZEMAIRA®. KCENTRA® (4 factor prothrombin complex concentrate) recorded sales growth of 10%1, as social mobility increased post COVID. ZEMAIRA® Alpha1-Proteinase Inhibitor (Human) sales were up 24%1 as supply returned. Plasma Collections Plasma collections were robust with plasma volumes up 31% and now at record levels. Improved social mobility post COVID, targeted marketing campaigns and enhanced digital initiatives to attract donors all contributed to this unprecedented growth. The cost of collecting plasma, which includes donor compensation and labour, declined ~14% over the previous year end and ~17% down from the peak in March 2022. The significant increase in plasma supply underpins the company’s ability to manufacture plasma products and enables CSL to meet the underlying patient demand for core plasma products. CSL Seqirus Total revenue of US$2,031 million, was up 9%1 driven by growth in seasonal influenza vaccines, in particular FLUCELVAX® which increased 30%1. This growth was achieved against a backdrop of reduced rates of immunisation and highlights the strength of CSL Seqirus’ strategy and its high value, differentiated product portfolio. During the period: • A licence agreement was signed with Arcturus Therapeutics for next-generation mRNA vaccine technology. • The United States Centers for Disease Control and Prevention recognised FLUAD® as a preferentially recommended seasonal vaccine option for adults aged 65+ years. • Fill and finish capacity expansion now fully operational at Holly Springs and Liverpool. • Good progress was made on construction of the new cell-culture facility in Melbourne. CSL Vifor Total revenue was US$1,989 million representing approximately 11 months contribution since the business was acquired on 9 August 2022. This amounts to approximately 14% growth1,2 compared to the 11 months in FY22 before CSL ownership, reflecting solid growth across all key product areas. The integration of CSL Vifor is well advanced and the cost synergies are well on track. During the period INJECTAFER® (ferric carboxymaltose) was approved in the United States for the treatment of iron deficiency in adult patients with heart failure and FERINJECT® was launched in China in April 2023. Outlook The strong growth in the immunoglobulins franchise is expected to continue following record plasma collections in FY23. There are a number of initiatives underway to improve efficiencies which include a focus on optimising plasma collection costs, improving manufacturing yields and bringing new products to market, all of which will support the medium term recovery in CSL Behring’s gross margin. The launch of HEMGENIX®, in the United States last quarter will continue to deliver this paradigm-shifting treatment to the haemophilia B community in the United States and Europe in the year ahead. The R&D pipeline includes a number of late-stage programs nearing completion which will lead to more options for patients. CSL Seqirus is anticipated to deliver another strong year driven by demand for its differentiated products. CSL Seqirus is progressing global registrations for its next-generation mRNA COVID vaccine. For CSL Vifor, there is a focus on unlocking the value and growth within this newly acquired business. Supporting the medium-term outlook, research and development capabilities are being brought into the one R&D organisation. Nephrology and transplant therapeutic areas are being brought together and a number of patient bloodmanagement initiatives are underway that will cross between CSL Vifor and CSL Behring businesses. Further information Additional details about CSL’s results are included in the company’s 4E statement, investor presentation slides and webcast, all of which can be found on CSL’s website csl.com. A glossary of medical terms can also be found on the website.
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