CSL Behring

CSL Behring delivered an exceptional year, with growth in all product sales groups. Total sales of US$5.8 billion grew 12% in constant currency over the previous year with sales increases at constant currency of 14% for immunoglobulins, 7% for albumin, 4% for haemophilia products and 20% in the specialty products portfolio.

Immunoglobulins (Ig) represent our largest therapy area and contributed sales of US$2,774 million, up 14% in constant currency over last year. Intravenous immunoglobulin (IVIG) sales growth was underpinned by solid global demand for PRIVIGEN®, Immune Globulin Intravenous (Human) 10% Liquid, with sales up 21% in constant currency over the prior comparable period. Excellence in execution, a focused approach to growth in the non-acute segment, and use of PRIVIGEN to treat chronic inflammatory demyelinating polyneuropathy (CIDP) contributed to this impressive growth.

Sales of our subcutaneous immunoglobulin product, HIZENTRA®, Immune Globulin Subcutaneous (Human) 20% liquid, increased by 10% at constant currency, led by strong demand in the US and Europe. New patient starts on HIZENTRA and patients converting from IVIG were key drivers of growth, particularly in Belgium, France, United Kingdom, the Nordic region, Brazil and Mexico.

CSL Behring’s portfolio of albumin products yielded sales of US$840 million, an increase of 7% at constant currency, primarily driven by strong ongoing global demand. China delivered another remarkable year of albumin growth, up 13% fuelled by ongoing successful sales penetration into lower tier cities and hospitals.

Overall, the haemophilia product franchise increased 4% in constant currency, versus the prior year to US$1,023 million. Growth in this franchise was due predominantly to the introduction and uptake of our recombinant therapies IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, and AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, in new and existing markets.

This year, IDELVION, our novel long-acting recombinant albumin fusion protein for treating haemophilia B, launched in Japan. IDELVION delivers high-level protection maintaining factor IX activity levels above five percent in most patients over 14-days, resulting in a median annualised spontaneous bleeding rate of zero. Appropriate patients can go up to two weeks between infusions and achieve excellent bleeding control. The flexibility to reduce their dosing cycle is an important attribute for patients who require a prophylactic regimen but don’t want treatment to disrupt their active lives.

We also launched AFSTYLA in Europe. AFSTYLA is the first and only single-chain product for haemophilia A specifically designed for long-lasting protection from bleeds with the ability to dose twice weekly. Both products are off to a promising start with ongoing approvals in various countries and launches planned in the coming year.

Our specialty products grew 20% in constant currency terms to sales of US$1,174 million. Sales of KCENTRA®, 4 Factor Prothrombin Complex Concentrate, in the US were particularly strong driven by our team’s effort to achieve deeper penetration into targeted accounts. RESPREEZA®, a maintenance treatment for severe Alpha-1 Antitrypsin Deficiency, continued to grow in Europe due to launches in further European markets, and post-launch uptake in the initial launch markets. RESPREEZA has been shown to slow the progression of hereditary emphysema. Increased awareness, diagnosis and treatment of hereditary angioedema (HAE) in Europe saw strong growth of BERINERT®, C1- esterase inhibitor concentrate, aided also by competitor supply disruptions in the US.

At the close of 2016/2017, the US Food and Drug Administration (FDA) granted approval for HAEGARDA®, C1 Esterase Inhibitor Subcutaneous (Human), the first and only subcutaneous C1 esterase inhibitor therapy indicated for routine prophylaxis to prevent HAE attacks in adolescent and adult patients. In clinical studies, HAEGARDA demonstrated a 95% reduction in HAE attacks and more than a 99% reduction in the use of rescue medications, along with the ability to selfadminister subcutaneously. HAEGARDA launched in the US in July 2017, and has the potential to be a significant growth driver over the next few years.

On 13 June 2017, CSL announced that it had agreed to acquire an 80% equity of plasmaderived therapies manufacturer Wuhan Zhong Yuan Rui De Biological Products Co. Ltd. from Humanwell Healthcare Group Co. Ltd. for US$352 million. The acquisition provides CSL with a strategic presence in the Chinese domestic plasma fractionation market and complements the leadership position that CSL Behring has built over the past 20 years as a provider of imported albumin in China.

CSL Behring continues to invest in state-of- the-art manufacturing facilities around the world to meet growing demand for its products, increase efficiency and support its cohesive global manufacturing network.

Construction of CSL Behring’s new manufacturing operation for the recombinant coagulation products in Lengnau, Switzerland, is making excellent progress – the installation of major equipment is underway, and permanent employees are working onsite. Once operational, the facility will support the commercial production of the company’s novel recombinant coagulation family of therapies.

In Marburg, Germany, construction recently began on a €245 million expansion project for a new base fractionation facility, expected to be completed in 2023. The company is also continuing its €180 million, five-year modernisation and capacity expansion activities where a new 4,600-square-metre quality control, filling and packaging facility is nearing completion at this same site. This state of the art automated facility will increase the company’s overall capacity and productivity, and is expected to meet the needs of patients for many years to come.

The construction of a significant, new base fractionation plant neared completion at our facility in Kankakee, Illinois, US. The plant is expected to be operational in 2017/2018. In addition, planning for further base fractionation capacity is well underway.

At our facility in Broadmeadows, Australia, we continue to expand capacity in several areas. A new production module, expected to be complete in 2018 will double the plant’s capacity to produce PRIVIGEN and increase our global supply for Ig by 30%. We are also investing in the expansion of our new albumin production facility anticipated to receive approval in 2019, and on expansion projects to increase base fractionation.

In Bern, Switzerland, our recently completed facility to produce clinical trial products, for the study of CSL112, is online and fully operational. CSL112 is our novel form of apolipoprotein A-1, being investigated to reduce the high risk of early recurrent events following an acute myocardial infarction or heart attack. A decision of whether to move forward with the phase III trial will be made during the second half of 2017, following the availability of additional phase II data.

Within CSL Plasma, we continue to expand our fleet of plasma collection centres, opening 29 locations in 2016/2017, bringing our total to more than 170 centres in the US and Europe. As one of the largest and most efficient plasma collection operations in the world, this unparalleled growth gives us confidence we can collect sufficient plasma to stay ahead of demand and assure reliable supply of our products to our patients well into the future.

 


CSL Behring’s new albumin production facility in Broadmeadows, Australia, is anticipated to receive regulatory approval in 2019.

CSL Behring’s new albumin production facility in Broadmeadows, Australia, is anticipated to receive regulatory approval in 2019.