CSL (ASX:CSL)

Paul Perreault
CEO & MD
Market Cap (AUD): 112.73B
Sector: Health Care
Last Trade (AUD): 252.77 +4.45 (+1.76%)
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1. About

The Commonwealth Serum Laboratories was established in Australia in 1916 to service the health needs of a nation isolated by war. Over the ensuing years CSL provided Australians with rapid access to 20th century medical advances including insulin and penicillin, and vaccines against influenza, polio and other infectious diseases. CSL Limited was incorporated in 1991 and listed on the Australian Securities Exchange (ASX) in 1994.

Since then, CSL has acquired a number of companies. They include: Aventis Behring, which is now known as global biotech leader CSL Behring, U.S. plasma collector Nabi, which helped to form the world's premier plasma collection company in CSL Plasma, the Novartis influenza vaccine business, now integrated and known as Seqirus, the world's second largest influenza vaccines company and Calimmune, a leader in gene-modification and cell delivery technology. Their combined and rich histories make CSL the innovative global leader it is today.

CSL Behring

CSL Behring is a global biotechnology leader with the broadest range of quality medicines in the industry and substantial markets throughout the world. Its therapies are indicated for bleeding disorders, immunodeficiencies, hereditary angioedema, neurological disorders and Alpha-1 Antitrypsin Deficiency. Visit CSL Behring

CSL Plasma

A subsidiary of CSL Behring, CSL Plasma is the largest collector of human blood plasma in the world, sourcing plasma from hundreds of thousands of donors globally to produce a range of life-saving medicines for critically ill patients. Visit CSL Plasma

Seqirus

Seqirus is one of the largest influenza vaccine companies in the world and a major partner in the prevention and control of influenza globally. It is a transcontinental partner in pandemic preparedness and response, and a leading supplier of influenza vaccines to global markets for both northern and southern hemisphere seasons. Visit Seqirus

2. Business model

 

The Company operates in following divisions:[1]

 

Divisions

Revenue ($M)

% of Revenue

% of Profit (before Int, Tax, Depn & Amort)

Profit drivers[2]

CSL Behring

$6,827.0

86.3%

96.4%

Total sales in constant currency grew 10% over the previous year to US$6.6 B with sales increases at constant currency of 11% for immunoglobulins, 24% for the specialty portfolio, 7% for albumin, and 5% for haemophilia products

Seqirus

$1,088.3

13.7%

3.6%

Total revenue for the reporting period totalled US$1,088 M, representing constant currency growth of 16% compared to the prior year. Seasonal influenza vaccine sales in the US continued to generate the majority of its revenue with solid contributions from its global pandemic franchise as well as its vaccine and pharmaceutical in-licensing business in Australia and New Zealand

3. Strategy

 

  • Continued strong demand for plasma and recombinant products[3]
  • Margin growth from plasma product mix shift, specialty and recombinant products growth & conclusion of HELIXATE® supply
  • CSL's collections growth expected to outpace the market but supply remains a limiting factor
  1. ~30 to 35 centre openings in FY19
  2. Modest increase in plasma costs anticipated
  • Seqirus tracking to plan
  • Ongoing investment to support growth:
  1. Capital expenditure FY19 ~$1.2 - $1.3 billion
  2. R&D up ~$150 - $200 million to ~10% of revenue following commencement of CSL112 Phase 3

4. Markets

     

The Company operates in markets including:[4]

 

Industry

Industry Revenue (2018)

Growth Rate

Pharmaceuticals Wholesaling (Australia)

$14 billion

2.6% (annual 14-19)

Scientific Research Services (Australia)

$8 billion

3.6% (annual 14-19)

Pharmaceutical Product Manufacturing (Australia)

$8 billion

(1.9%) (annual 14-19)

Pharmaceuticals & Medicine Manufacturing (Global)

$1 trillion

2.1% (annual 13-18)  

5. Competition

 

Major competitors Include:[5]

 

  • Baxter International Inc (NYSE:BAX)
  • Sanofi SA (EPA:SAN)
  • Grifols SA (BME:GRF)

6. History

 

1904[6]   

Nobel Prize winner Dr. Emil von Behring establishes Behringwerke in Marburg, Germany, to produce sera and vaccines

 

1915   

The decision to establish a federal serum institute (CSL) was announced

 

1916   

Dr. William Penfold is appointed founding Director of the Commonwealth Serum Laboratories, starting his first day of work on 25 April

 

1917   

The Walter and Eliza Hall Institute of Medical Research (WEHI) provides CSL with free temporary accommodation in Melbourne

 

1918   

CSL moves to a permanent site in Parkville, where it continues to operate today

 

1919   

When the Spanish Flu strikes Australia, CSL responds rapidly with three million doses of a mixed bacterial vaccine

 

1920  

CSL expands its product range to include five sera, 24 vaccines, four tuberculins,plus a range of diagnostic agents

 

1922   

CSL introduces veterinary products to help protect Australia’s agricultural interests

 

1923   

Soon after the discovery of insulin in Canada, CSL becomes one of only four laboratories in the world licensed to make it

 

1925   

CSL starts producing sera to prevent and treat infectious diseases

 

1927   

Dr. Penfold leaves CSL and is succeeded as Director by Dr. FG Morgan

 

1930   

After collaborating with WEHI, CSL releases antivenom against the deadly tiger snake

 

1934   

CSL opens an additional site in Broadmeadows, Melbourne

 

1935   

An independent research department is established at CSL under Dr. Bill Keogh

CSL manufactures large quantities of a new vaccine developed by the CSIRO to prevent black disease in sheep

 

1939   

During WWII, CSL becomes an essential provider of blood- typing sera for service personnel and issues millions of doses of preventative medicines for infectious diseases

 

1940   

Collaborating with Harvard’s Dr. Edwin Cohn, Chicago-based Armour Laboratories becomes the largest supplier of human albumin to the US military during WWII

 

1944   

CSL starts production of influenza virus vaccine, supplying one million doses to Australian and British troops

CSL starts production of penicillin, providing urgent supplies to Australian and US forces. Australia becomes the first country to provide penicillin to civilians

 

1946   

Behringwerke is the first company in Europe to begin fractionating human blood plasma on an industrial scale

 

1949   

The Swiss Red Cross establishes Zentrallaboratorium Blutspendedienst (ZLB), in Bern, Switzerland

 

1951   

The World Health Organisation (WHO) designates CSL as an Influenza Reference Laboratory

ZLB ensures the supply of blood products through the Swiss Red Cross Blood Transfusion Service

 

1952   

CSL starts fractionation of plasma collected by the Australian Red Cross from voluntary blood donors

 

1953   

CSL manufactures Triple Antigen vaccine to protect children from diphtheria, tetanus, and whooping cough

Armour Laboratories opens its new plasma fractionating facility in Kankakee, near Chicago

 

1954   

ZLB issues the world’s first plasma protein solution and develops modifications to the Cohn fractionation process

 

1956   

Dr. Morgan retires from CSL and is succeeded by Dr. Percival ‘Val’ Bazeley

Just a few months after Jonas Salk’s US breakthrough, CSL commences large scale production of polio vaccine. The disease is virtually eliminated in Australia within a decade

 

1958   

CSL responds quickly to protect Australians from the Asian Flupandemic, producing 1.6 million doses of vaccine

 

1961   

CSL is incorporated as a Commonwealth Statutory Authority in an attempt to make it become more commercial and profitable

CSL’s Animal Health division develops a five-in-one vaccine that becomes Australia’s most popular veterinary product

CSL starts plasma fractionation for New Zealand, and later for Hong Kong, Malaysia, Singapore, and Taiwan

 

1967   

In a world first, CSL issues Rhesus (D) immunoglobulin for the prevention of haemolytic disease in newborns

 

1969   

CSL acts quickly to protect Australia during the Hong Kong Flu pandemic, producing five million doses of vaccine

 

1973   

CSL begins to re-assort influenza strains so they grow better in eggs, providing them to the WHO to share with all flu vaccine manufacturers

 

1974   

Dr. Neville McCarthy from multinational pharmaceutical company, ER Squibb & Co, is appointed as CSL Director

 

1979   

ZLB, in collaboration with Sandoz AG, Switzerland, launches the world’s first purified immunoglobulin product for intravenous infusion

 

1981   

CSL enters an ongoing partnership with US based Merck & Co to distribute Merck & Co. Inc. vaccines in Australia and NZ.

Elusive to scientists for 50 years, a funnel web spider antivenom is finally developed by CSL’s Dr. Struan Sutherland

Behringwerke launches HAEMATE®, the world’s first pasteurised factor VIII product for the treatment of Haemophilia A

 

1983   

CSL adds protection against cheesy gland to its popular five-in-one vaccine for sheep, producing the top-selling product GLANVAC®

 

1990   

CSL appoints 33 year-old Dr. Brian McNamee as the company’s CEO

 

1991   

CSL is corporatised by the Australian Government to build a “great and independent Australian company”

CSL collaborates with Professor Ian Frazer, and later Merck & Co., Inc., to develop the world’s first HPV vaccine

 

1992   

CSL purchases local animal sera supplier, Filtron, for A$2 million to boost its cell culture business.

The WHO designates CSL as an Influenza Collaborating Centre

 

1993  

The Australian Government transfers ownership of the partly completed plasma fractionation facility at Broadmeadows to CSL

 

1994   

CSL debuts on the Australian Securities Exchange with a value of $299 million and a day one closing share price of A$2.43.

Equivalent of A$0.81 today following the companies 3-for-1 share split in 2007

CSL acquires US-based cell culture company JRH Biosciences for A$27 million; an important first step towards globalisation

 

1996   

A joint venture is established between Armour Pharmaceuticals and Behringwerke, called Centeon

 

1998   

CSL acquires US-based Animal Health business Biocor from Bayer for A$15 million

 

1999   

Centeon changes its name to Aventis Behring when its parent companies merge to become Aventis

 

2000   

CSL acquires ZLB from the Swiss Red Cross for A$930 million; a major step towards global leadership in plasma therapeutics

Aventis Behring acquires 42 plasma donation centres from US-based Serologicals Corporation, creating the world’s largest plasma collection business

 

2001   

CSL acquires 47 plasma donor centres and testing facilities from US-based Nabi for A$317 million and creates ZLB Plasma Services

 

2004   

In a bold move, CSL acquires Aventis Behring for A$1.23 billion, combining it with ZLB operations to create CSL Behring, a global leader in Biotherapeutics

 

2005   

As part of the strategy to reshape the company, CSL divests JRH Biosciences to Sigma-Aldrich for A$458 million and its Animal Health business to Pfizer for A$162 million

 

2006   

CSL acquires Melbourne biotech company Zenyth Therapeutics for A$104 million, strengthening CSL’s pipeline and recombinant protein capabilities.

The FDA approves the world’s first HPV vaccine, GARDASIL® which goes on to deliver royalties to CSL of upto A$100 million each year

CSL Behring starts construction on a new manufacturing facility in Bern for next generation immunoglobulin products PRIVIGEN® and HIZENTRA ®

 

2007   

CSL’s share price breaks through the A$100 mark and the company undertakes a 3-for-1 share split

CSL Behring launches category-leading PRIVIGEN®, the first and only liquid intravenous immunoglobulin requiring no refrigeration or reconstitution

 

2009   

CSL’s rapid response to the H1N1 (Swine Flu) pandemic sees Australia become one of the first nations to supply vaccine to its population.

In Knoxville, Tennessee, CSL Behring establishes the world’s largest and most advanced plasma testing laboratory

CSL formally establishes an office in China to support increased demand for albumin and future growth in the region

As part of pandemic preparedness, the US Government and Novartis announce a new cell-based manufacturing facility for influenza vaccines

 

2010   

CSL announces a new biotech facility for experimental recombinant therapies and a new plasma manufacturing plant for PRIVIGEN® in Broadmeadows

CSL commences clinical trials for novel recombinant therapies for people with Haemophilia A and B

CSL Behring launches HIZENTRA®, the first and only 20% subcutaneous immunoglobulin for patients with primary immune deficiency

CSL Plasma opens its first ‘Centre of the Future’ in the US, enhancing the donor experience and improving plasma collection efficiencies

 

2012   

CSL delivers a US$1 billion net profit after tax for the first time since listing

CSL integrates its Broadmeadows operations with CSL Behring and creates a stand-alone vaccine,

pharmaceuticals and diagnostics business called bioCSL

 

2013  

Paul Perreault, CSL Behring President at the time, is named CEO following Dr. Brian McNamee’s decision to step down after 23 years leading the company

HIZENTRA® is granted approval in Japan, CSL Behring’s first major product approval in Japan since the Aventis Behring acquisition

 

2014   

CSL Behring’s site in Kankakee gets FDA approval for a major plasma manufacturing expansion, which will support future demand for biotherapies

 

2015   

CSL acquires the Novartis influenza vaccine business for US$275 million, combining it with bioCSL to create Seqirus, the world’s Second-largest flu vaccine manufacturer

CSL’s share price exceeds A$100 per share again, climbing from A$36.36 in 2007 when CSL undertook a 3-for-1 share split

Seqirus achieves FDA approval for FLUAD®, the only licensed adjuvanted seasonal influenza vaccine and advances development of quadrivalent flu vaccines.

CSL Behring starts construction of a new large-scale production facility in Lengnau, Switzerland for its novel recombinant therapies

CSL Behring issues its first exports of PRIVIGEN® from the new turner manufacturing facility at its Broadmeadows site

 

2016   

CSL Behring achieves major regulatory milestones for its novel recombinant therapies, starting with the approval of IDELVION®, a long-acting clotting factor for patients with haemophilia B and AFSTYLA®, the first and only single-chain product for haemophilia A

CSL announces a global hub for research and translational medicine at the Bio21 Institute, University of Melbourne

CSL begins planning for phase III clinical trial of a novel plasma-derived therapy for acute coronary syndrome

CSL celebrates its centenary as an A$50 billion global biotherapeutics leader, employing over 16,000 people in more than 30 countries and serving patients all around the world

 

2017   

CSL Behring Acquires Biotech Company Calimmune and its Proprietary Stem Cell Gene Therapy Platform

7. Team

 

Board of Directors[7]

 

Brian McNamee, AO – Chairman

Paul Perreault – Chief Executive Officer and Managing Director

Andrew Cuthbertson, AO – Chief Scientific Officer and R&D Director

Bruce Brook – Chairman of the Audit and Risk Management Committee and a member of the Nomination Committee

DR. Megan Clark AC – Member of the Human Resources and Remuneration Committee, the Innovation and Development Committee and the Nomination Committee

Abbas Hussain – Member Innovation and Development Committee and the Human Resources and Remuneration Committee

Marie McDonald – Member of the Audit and Risk Management Committee, the Nomination Committee and the Human Resources and Remuneration Committee

Christine O’Reilly – Member of the Audit and Risk Management Committee, the Human Resources and Remuneration Committee, and the Nomination Committee

Dr. Tadataka “Tachi” Yamada KBE – Member of the Innovation and Development Committee and the Nomination Committee

Fiona Mead – Company Secretary

 

Management Team

 

Paul Perreault – Chief Executive Officer and Managing Director

David Lamont – Chief Financial Officer

Gordon Naylor – President, Seqirus

Val Romberg – Executive Vice President Manufacturing and Planning

Andrew Cuthbertson – Chief Scientific Officer and R&D Director

Bill Campbell – Executive Vice President and Chief Commercial Officer

Karen Etchberger – Executive Vice President Quality and Business Services

Greg Boss – Executive Vice President – Legal, and CSL Limited Group General Counsel

Elizabeth Walker – Executive Vice President, Chief Human Resources Officer

Alan Wills – Executive Vice President Strategy and Business Development

Bill Mezzanotte – Executive Vice President Research & Development


read more

8. Financials

 

2018 Full Year Results Presentation

 

Financial Year 2017/18 (ended 30 June):[8]

 

Divisions

Revenue ($M)

% Change

Profit (before Int, Tax, Depn & Amort) ($M)

% Change

CSL Behring

$6,827.0

13.3%

$2,580.3

18.2%

Seqirus

$1,088.3

17.8%

$96.7

177.7%

Total

$7,915.3

13.9%

$2,677.0

30.1%

9. Risk

 

Major risks include:[9]

 

Healthcare Industry Risk  

  • CSL faces competition from pharmaceutical companies and biotechnology companies. The introduction of new competitive products or follow-on biologics by its competitors may impact its ability to access fast-growing/strategic markets and may result in reduced product sales and lower prices. In addition, industry wide shifts in demand for its products may affect its business and operations
  • Accessing fast-growing or strategic markets and executing on value-creating business development deals are key growth opportunities for CSL. If these activities are unsuccessful its business and financial performance could be adversely affected.
  • CSL operates in many countries and changes in the regulatory framework under which the Company operates in these countries could have a negative impact on its business and operations. Healthcare industry regulations address many aspects of its business including, but not limited to, clinical trials, product registration, manufacturing, logistics, pharmacovigilance, reimbursement, and pricing.

 

Manufacturing & Supply Risk  

  • The manufacture of CSL’s products, in accordance with regulatory requirements, is a complex process including fractionation, purification, filling, and finishing. Any challenges experienced in the continuity of this process, and/or the quality of supply, could have a negative impact on its business results
  • CSL depends on a limited group of companies that supply its raw materials and supply and maintain its equipment. If there is a material interruption to the supply or quality of a critical raw material or finished product, this could disrupt production or its commercial operations. If the equipment should malfunction or suffer damage, the repair or replacement of the machinery may require substantial time and cost, which could disrupt production and other operations
  • CSL also depends on plasma donors for the supply of plasma. Ineffective management of donors has the potential to impact supply and may also have reputational consequences.

 

Research and Development/Commercialisation Risk  

  • Its future success depends significantly on its ability to continue to successfully develop new products. The success of such development efforts involves great challenge and uncertainty. To achieve this, the Company must conduct, at its own expense, by ourselves or by its collaboration partners, early-stage research and clinical trials to demonstrate proof of concept and the safety and efficacy of the product candidates. Clinical trials are expensive, difficult to design and implement, can take multiple years to complete and are uncertain as to the outcome
  • Commercialisation requires effective transition of research and development activities to business operations

 

Business Combination Risk

  • Potential business combinations could require significant management attention and prove difficult to integrate with CSL’s business
  • CSL may not realise the anticipated benefits, or it may take longer to do so than anticipated, from any business combination the Company may undertake in the future and any benefits the Company do realise may not justify the acquisition price

 

Tax Risk

  • Tax reform policy continues to be a topic of discussion in the United States and many other countries in which the Company operate. Changes in tax laws or exposure to additional tax liabilities may have an impact on its financial performance..

 

Information  Security,  including Cybersecurity

  • Most of CSL’s operations are computer-based and information technology (IT) systems are essential to maintaining effective operations
  • CSL’s IT Systems are exposed to risks of complete or partial failure of IT systems or data centre infrastructure, the inadequacy of internal or third-party IT systems due to, amongst other things, failure to keep pace with industry developments and the capacity of existing systems to effectively accommodate growth, unauthorised access and integration of existing operations.

 

Intellectual Property Risk

  • CSL relies on an ability to obtain and maintain protection for its intellectual property (IP) in the countries in which the Company operate
  • CSL’s products or product candidates may infringe, or be accused of infringing, on one or more claims of an issued patent, or may fall within the scope of one or more claims in a published patent application that may be subsequently issued and to which the Company does not hold a licence or other rights.

 

Personnel Risk

  • Providing a safe and rewarding work environment for CSL’s employees is critical to its sustainability.
  • CSL is dependent on the principal members of its executive and scientific teams. The loss of the services of any of these persons might impede the achievement of its research, development, operational and commercialisation objectives.

 

Unexpected Side Effects Risk

  • As for all pharmaceutical products, the use of CSL’s products can produce undesirable or unintended side effects or adverse reactions (referred to cumulatively as “adverse events”). The occurrence of adverse events for a particular product or shipment may result in a loss and could have a negative impact on CSL’s business and reputation, as well as results of operations

 

Market Practice Risk

  • CSL’s marketplace is diverse and complex, presenting many opportunities and challenges. Breach of regulations, local or international law, or industry codes of conduct, may subject us to financial penalty and reputational damage. Such instances may invite further regulation that may negatively affect its ability to market therapies.

 

Financial Risks :

Foreign Exchange Risk

The objective is to match the contracts with committed future cash flows from sales and purchases in foreign currencies to protect the Group against exchange rate movements. The Group reduces its foreign exchange risk on net investments in foreign operations by denominating external borrowings in currencies that match the currencies of its foreign investments. The total value of forward exchange contracts in place at reporting date is nil (2017: Nil).

 

Interest Rate Risk

At 30 June 2018, it is estimated that a general movement of one percentage point in the interest rates applicable to investments of cash and cash equivalents would have changed the Group’s profit after tax by approximately $5.7m. This calculation is based on applying a 1% movement to the total of the Group’s cash and cash equivalents at year end. At 30 June 2018, it is estimated that a general movement of one percentage point in the interest rates applicable to floating rate unsecured bank loans would have changed the Group’s profit after tax by approximately $5.8m. This calculation is based on applying a 1% movement to the total of the Group’s floating rate unsecured bank loans at year end.

 

Credit Risk

Financial assets are considered impaired where there is evidence that the Group will not be able to collect all amounts due according to the original trade and other receivable terms. Factors considered when determining if a financial asset is impaired include ageing and timing of expected receipts and the credit worthiness of counterparties. Where required, a provision for impairment is created for the difference between the financial asset’s carrying amount and the present value of estimated future receipts. The Group’s trading terms do not generally include the requirement for customers to provide collateral as security for financial assets. The Group has not renegotiated any material collection/repayment terms of any financial assets in the current financial year. Government or government-backed entities (such as hospitals) often account for a significant proportion of trade receivables. As a result, the Group carries receivables from a number of Southern European governments. The credit risk associated with trading in these countries is considered on a country-by-country basis and the Group’s trading strategy is adjusted accordingly. The factors taken into account in determining the credit risk of a particular country include recent trading experience, current economic and political conditions and the likelihood of continuing support from agencies such as the European Central Bank. An analysis of trade receivables that are past due and, where required, the associated provision for impairment, is as follows. All other financial assets are less than 30 days overdue.

 

Funding and Liquidity Risk

Interest-bearing liabilities and borrowings are recognised initially at fair value, net of transaction costs incurred. Subsequent to initial recognition, interest-bearing liabilities and borrowings are stated at amortised cost, with any difference between the proceeds (net of transaction costs) and the redemption value recognised in the statement of comprehensive income over the period of the borrowings. Fees paid on the establishment of loan facilities that are yield related are included as part of the carrying amount of the loans and borrowings. Borrowings are classified as current liabilities unless the Group has an unconditional right to defer settlement of the liability for at least 12 months after the reporting date.

 

Capital Management Risk        

The Group’s objectives when managing capital are to safeguard its ability to continue as a going concern while providing returns to shareholders and benefits to other stakeholders. Capital is defined as the amount subscribed by shareholders to the Company’s ordinary shares and amounts advanced by debt providers to any Group entity.