The presentation began with Perreault acknowledging that CSL Limited (CSL:AU) is not as well
known since it is listed on the Australian stock exchange; nevertheless, he highlighted that it is
actually the fifth largest biotech company in the world. The company’s current primary focuses
are upon plasma supplies, immunoglobin therapies, and influenza vaccines- with plasma
therapies accounting for the majority of their ~$8 billion in revenues. CSL Limited is dedicated to
spending $1 billion in capital to build its capacity and holds a solid financial position. Supplying
plasma can be challenging and the company is devoted to addressing the steady, robust demand
for immunoglobulins by its opening of 30-35 new collection centres. CSL Limited is the parent
company of Seqirus, which is committed to the development of flu products. Perreault
emphasized that it is the only scaled flu cell culture manufacturer in the world and elucidated the
clinical benefits of FLUCELVAX- its cell culture quadrivalent vaccine- versus egg-based vaccines
and trivalent vaccines. Over 25 million doses of FLUCELVAX were produced in 2018 and the cell
culture approach is attractive compared to egg-based vaccines because it eliminates the need for
adaptation from egg to cell. Adding adjuvants to cell culture is CSL’s next step to enhancing its cell
culture vaccines.
In the past ten years, CSL Limited has performed consistently with a >11% compound annual
growth rate. CSL has achieved five major product launches (Idelvion, Afstyla, Haegarda, Privigen,
and Hizentra) in the past 24 months and Perreault singled out Idelvion for hemophilia B and
Haegarda for hereditary angioedema in particular as some of the most successful launches in the
industry as early market entrants. Idelvion’s annualized bleed rates were recapped during the
presentation and its advantageous fortnightly dosing schedule was touted compared to
competitors. It was mentioned that they are looking into further extending Idelvion’s convenient
dosing schedule to once every three weeks with a submission planned for the third quarter of
2019. In the coming year, CSL will be preparing to launch Haegarda in additional countries
amongst other product launches in new markets.
While immunology, neurology, haematology, and thrombosis platforms are presently core to
CSL’s assets, the company is moving into additional transplant, respiratory, and cardiovascular
and metabolic therapy areas. The serious complications associated with solid organ transplants
including antibody-mediated rejection and graft-versus-host disease associated with
hematopoietic stem cell transplantation, represent great opportunities. CSL’s strategy here is to
quickly bring products into Phase III development by curating products that have an existing realworld evidence base. On the respiratory front, a nebulized immunoglobulin therapy is being
developed to address the pulmonary exacerbation issues patients with primary
immunodeficiencies encounter that are potentially due to failure of the immunoglobulin to reach
the surface of the lung. Prevention of infections in primary immunodeficiency patients and
prevention of infection-related exacerbations in chronic obstructive pulmonary disease and
bronchiectasis patients may be viable indications for the nebulized immunoglobulin.
Furthermore, CSL112 is being investigated in the Phase III AEGIS II outcomes study in acute
coronary syndrome that is actively recruiting with over half of the countries on board so far. Data
are expected to be first reported in March 2020, with an update in October 2020, and interim
efficacy data to be released in April 2021. Following a year of follow-up, a BLA is planned for
submission in 2022 and the company will seek approval in the EU thereafter.
known since it is listed on the Australian stock exchange; nevertheless, he highlighted that it is
actually the fifth largest biotech company in the world. The company’s current primary focuses
are upon plasma supplies, immunoglobin therapies, and influenza vaccines- with plasma
therapies accounting for the majority of their ~$8 billion in revenues. CSL Limited is dedicated to
spending $1 billion in capital to build its capacity and holds a solid financial position. Supplying
plasma can be challenging and the company is devoted to addressing the steady, robust demand
for immunoglobulins by its opening of 30-35 new collection centres. CSL Limited is the parent
company of Seqirus, which is committed to the development of flu products. Perreault
emphasized that it is the only scaled flu cell culture manufacturer in the world and elucidated the
clinical benefits of FLUCELVAX- its cell culture quadrivalent vaccine- versus egg-based vaccines
and trivalent vaccines. Over 25 million doses of FLUCELVAX were produced in 2018 and the cell
culture approach is attractive compared to egg-based vaccines because it eliminates the need for
adaptation from egg to cell. Adding adjuvants to cell culture is CSL’s next step to enhancing its cell
culture vaccines.
In the past ten years, CSL Limited has performed consistently with a >11% compound annual
growth rate. CSL has achieved five major product launches (Idelvion, Afstyla, Haegarda, Privigen,
and Hizentra) in the past 24 months and Perreault singled out Idelvion for hemophilia B and
Haegarda for hereditary angioedema in particular as some of the most successful launches in the
industry as early market entrants. Idelvion’s annualized bleed rates were recapped during the
presentation and its advantageous fortnightly dosing schedule was touted compared to
competitors. It was mentioned that they are looking into further extending Idelvion’s convenient
dosing schedule to once every three weeks with a submission planned for the third quarter of
2019. In the coming year, CSL will be preparing to launch Haegarda in additional countries
amongst other product launches in new markets.
While immunology, neurology, haematology, and thrombosis platforms are presently core to
CSL’s assets, the company is moving into additional transplant, respiratory, and cardiovascular
and metabolic therapy areas. The serious complications associated with solid organ transplants
including antibody-mediated rejection and graft-versus-host disease associated with
hematopoietic stem cell transplantation, represent great opportunities. CSL’s strategy here is to
quickly bring products into Phase III development by curating products that have an existing realworld evidence base. On the respiratory front, a nebulized immunoglobulin therapy is being
developed to address the pulmonary exacerbation issues patients with primary
immunodeficiencies encounter that are potentially due to failure of the immunoglobulin to reach
the surface of the lung. Prevention of infections in primary immunodeficiency patients and
prevention of infection-related exacerbations in chronic obstructive pulmonary disease and
bronchiectasis patients may be viable indications for the nebulized immunoglobulin.
Furthermore, CSL112 is being investigated in the Phase III AEGIS II outcomes study in acute
coronary syndrome that is actively recruiting with over half of the countries on board so far. Data
are expected to be first reported in March 2020, with an update in October 2020, and interim
efficacy data to be released in April 2021. Following a year of follow-up, a BLA is planned for
submission in 2022 and the company will seek approval in the EU thereafter.
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