Group Overview

 

Aspen has a proud heritage dating back more than 160 years and is committed to sustaining life and promoting healthcare through increasing access to its high quality affordable medicines and products.

As a leading global player in specialty, branded and generic pharmaceuticals, Aspen has an extensive basket of products that provide treatment for a broad spectrum of acute and chronic conditions experienced through all stages of life. The Group continues to increase the number of lives benefitting from its products, reaching more than 150 countries. In line with the Group’s commercial, production and territorial strategies, Aspen has identified thrombosis, anaesthetics, high potency & cytotoxics and infant nutritionals as four therapeutic categories which will get the highest focus based on materiality and future potential.
 

Aspen holds international manufacturing approvals from some of the most stringent global regulatory agencies including the US FDA, TGA and EMA. Aspen’s manufacturing capabilities are scaleable to demand and cover a wide variety of product-types including oral solid dose, liquids, semi-solids, steriles, biologicals, APIs and infant nutritionals.

GLOBAL PRESENCE

Aspen has a strong presence in both emerging and developed countries with more than ​​​​​​​60 established business operations in approximately 50 countries. The Group supplies medicines and products to more than 150 countries. 

THE ASPEN TIMELINE

QUICK FACTS

Established: 1850
Employees: + 10 000
Market capitalisation: US$10 billion
Share code: APN
JSE: Top 20 on this exchange 

BOARD OF DIRECTORS

Stephen Saad (52)

Stephen Saad (52)

Qualification: CA(SA) Appointed: January 1999 Classification: Executive director; Group Chief Executive

Gus Attridge (55)

Gus Attridge (55)

Qualification: CA(SA) Appointed: January 1999 Classification: Executive director; Deputy Group Chief Executive

Kuseni Dlamini (48)

Kuseni Dlamini (48)

Qualification: MPhil (Oxon), BSocSci (Hons), (Natal) (See full CV’s) Appointed: April 2012 Classification: Independent non-executive, Chairman

Chris Mortimer (55)

Chris Mortimer (55)

Qualification: BA, LLB Appointed: January 1999 Classification: Non-executive

Babalwa Ngonyama(42)

Babalwa Ngonyama (42)

Qualification: CA(SA), MBA Appointed: April 2016 Classification: Independent non-executive

David Redfern (50)*

David Redfern (50)*

Qualification: BSc (Hons), CA Appointed: February 2015 Classification: Non-executive *British

Roy Andersen (68)

Roy Andersen (68)

Qualification: CA(SA), CPA (Texas), CD (SA) Appointed: August 2008 Classification: Lead independent non-executive

John Buchanan (72)

John Buchanan (72)

Qualification: CA(SA), BTh (Hons) EDP (Columbia) Appointed: May 2002 Classification: Independent non-executive

Maureen Manyama (39)

Maureen Manyama (39)

Qualification: CA(SA), BCom Honours (Taxation), MBA Appointed: June 2014 Classification: Independent non-executive

Sindi Zilwa (49)

Sindi Zilwa (49)

Qualification: CA(SA), CDSA, Advanced Taxation (UNISA) Certificate (See full CV’s) Appointed: September 2006 Classification: Independent non-executive

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Therapeutic focus

Thrombosis

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Anaesthetics

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High potency & Cytotoxics

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Infant nutritionals

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Thrombosis occurs as a result of the body’s hemostatic pathway being activated inappropriately, leading to the formation of blood clots.

There are a number of drugs that are used to treat patients who are at risk either to treat or prevent clotting which can be divided into three broad categories:

  • Anti-platelet;
  • Anticoagulant; and
  • Thrombosis products.

A common example of an anti-platelet agent is Aspirin (COX-inhibitor) low-dose, which works to prevent blood stickiness by irreversibly acetylating the red blood cell. Other classes within this category are ADP receptor pathway inhibitors, GPIIb-IIIa antagonists and phosphodiesterase inhibitors.

Thrombosis agents are molecules used to break up already formed clots to restore function to a vessel and prevent peripheral tissue damage. This form of therapy is performed in emergency situations using tissue plasminogen activators (t-PA).

Aspen’s global basket of thrombosis products fits into the anticoagulant category, aimed at the prevention and treatment of thrombotic disease, including deep vein thrombosis, pulmonary embolism and acute coronary syndrome.

This category is made up of oral and injectable agents, typically divided into the following categories:

  • Vitamin K antagonists such as Warfarin;
  • Heparin and derivatives such as low molecular, weight heparins and heparinoids;
  • Indirect Xa inhibitors such as Arixtra;
  • Direct factor Xa inhibitors such as Rivaroxaban; and
  • Direct Thrombin inhibitors such as Dabigatran.

Aspen’s presence in respect of this therapeutic category is in the low molecular weight heparins (Fraxiparin and Certoparin), Xa inhibitors (Arixtra) and heparin derivatives (Orgaran) referred to as a Heparinoid, which are indicated for the treatment of Heparin-induced thrombocytopenia and also as an anticoagulant.

The Group is positioned as one of the leading worldwide providers in this therapeutic category. Aspen is currently the second largest provider to the European injectable anticoagulant sector (with 15% of the sector share) and the third largest participant in the total European anticoagulant sector (with 10% of the sector share). The IMS forecasts growth for the global demand for injectable anticoagulant products at a CAGR of 4,5% during the period 2016 to 2020.

Anaesthetic products are categorised into two classes, namely general anaesthetics, which cause a reversible loss of consciousness; and local or regional anaesthetics, which cause a reversible loss of sensation locally (eg for local surgical procedures) or for a limited region of the body such as epidural anaesthesia, while maintaining consciousness.

Aspen’s acquisition of the rights to six local or regional and one general AstraZeneca anaesthetic products globally (except the USA), and five GSK anaesthetic products for general anaesthesia use globally (with the exception of certain territories, primarily North America) will position it as one of the leading providers of anaesthetic products worldwide as it will hold a 20% share in this therapeutic category globally (outside the USA), a sector IMS values at USD3 billion, and will be the leading supplier of these products in multiple countries, including China, Japan, Brazil, South Africa, Australia and certain Nordic countries. As a consequence of these transactions four of the top 10 anaesthetic products globally (excluding the USA) will be Aspen products.

A variety of products is used in general anaesthesia for induction, maintenance and recovery. The classes of products where Aspen has acquired the rights in general anaesthesia are related to:

  • induction and maintenance (Propofol acquired from AstraZeneca);
  • opioids used during induction, maintenance and recovery (Remifentanil acquired from GSK); and
  • neuro-muscular, blocking drugs used to facilitate intubation and to relax the muscles for surgical procedures (Cisatracrurium, Atracrurium and Mivacrurium and Succinylcholine acquired from GSK).

Local/regional anaesthetics include topical agents, in which class Aspen has acquired ointments, creams, gels, patches and sprays (Emla acquired from AstraZeneca).

High potency pharmaceuticals include molecules that are typically corticosteroid or hormonal in nature and which have intrinsic efficacy at very low doses, requiring specialised manufacturing conditions, catering for both employee health and safety as well as product efficacy.

Most of these molecules have a narrow therapeutic index, allowing for a small window between the effective and toxic doses. These products are mainly used in life-saving chronic medical conditions. The leading class in this product segment, with a combined global value of USD3,4 billion and annual volume growth of 7% (as measured by IMS at 31 December 2015), are products designed to treat under-active thyroid conditions such as Aspen’s Eltroxin, Eutroxsig, Oroxine and Thyrax. Another important product in this segment is Florinef, a specific high-potency mineral corticoid used in adrenal insufficiency, classified by the WHO as an essential medicine.

Aspen also actively promotes two anabolic steroid products in this product segment, namely Deca-Durabolin and Sustanon, as well as a basket of glucocorticoids, Meticorten/Oradexon/Decadron and Meticortelone in various dosage forms, mostly in the Latin American and Asian regions.

During the year under review Aspen acquired and launched the HPC FDF, which is indicated for the treatment of certain female cancers and hormonal imbalances, and Benztropine, used primarily for the treatment of Parkinson’s disease.

Cytotoxic products are mainly oncological molecules focused on haematology and immunosuppression. Aspen’s products fall within the antimetabolites product class, which has a global IMS value of USD7,4 billion, and the alkylating agents class which has a global IMS value of USD2,7 billion. These brands are used in combination regimens with other oncological products, centred on research-based clinical trials aimed at ensuring improved survival and quality-of-life outcomes.

Female health has been identified as a potential growth segment for Aspen, considering that the Group manufactures the APIs for multiple female health products globally, including a number of oral contraceptive and hormonal replacement therapy products it acquired from MSD in the 2014 financial year. Aspen is well positioned to take advantage of its specialised manufacturing expertise to develop and commercialise its own branded portfolio in this growing segment.

Aspen supplies a wide range of infant nutritional and growing-up milk products across both the premium and value segments for these products. Infant nutritionals are used for infants under 12 months of age who are unable to be breastfed while growing-up milk formulas are used to supplement the diet of children older than 12 months. These products are usually prepared for bottle-feeding or cup-feeding from powder (mixed with water) or liquid (with or without additional water).

The most commonly used infant nutritionals contain purified cow’s milk whey and casein as a protein source, a blend of vegetable oils as a fat source, lactose as a carbohydrate source, a vitamin-mineral mix and a variety of other ingredients depending on the manufacturer. Paediatric nutritionals are dietary supplements intended to provide nutrients to children between the ages of one and three that may otherwise not be consumed in sufficient quantities.

Despite the global economic downturn and slow recovery, the worldwide demand for nutritional products continues to grow. Research indicates that it is one of the fastest-growing packed food categories, with an estimated global demand in excess of USD46 billion in 2016 and with a predicted CAGR in excess of 9% over the period 2015 to 2020 (source: Euromonitor). The strong growth in this category is bolstered by emerging markets, where there is an increasing standard of living, participation of women in the workplace and higher birth rates. The main growth regions are Asia (led by China, the world’s largest consumer of infant nutritionals), the Middle East, Africa and to a lesser extent, South America.

Aspen has the rights to manufacture and market the S-26 and SMA brands in southern Africa, Australia and Latin America. This, combined with the strong position of the Infacare brand in Africa, gives Aspen a strong infant nutritionals presence on four continents and positions it as the 15th largest infant nutritionals business globally with an estimated 0,70% of worldwide market share (source: Euromonitor). In addition, Aspen is one of only two companies in the top 15 that is also a pharmaceutical company, providing additional credibility due to Aspen’s rigorous safety and quality standards.