APOTEX, INC. and compliance requirements. We value and respect our employees, our business partners, our Preparation questions: Based on your reading of the suppliers, our customers and the communities we materials, together with your understanding of serve while operating with accountability and strategies for generic drug manufacturers, what are integrity in everything we do. the key challenges that Apotex faces in its market Background segment? o Apotex Inc. is the largest Canadian-owned pharmaceutical company. From its 2 Contents employees, 5,000 square foot beginning, the A. Company overview (November 2012, updated company has grown to employ over 6,800 October 2013) people in research, development, B. Apotex generic drug approvals in the US, manufacturing and distribution facilities 2001-2012 world-wide. The Canadian operations of the C. Example of a successful introduction (Norvasc) Apotex Group of Companies with 5,800 D. Example of an unsuccessful introduction employees now occupy over 3.4 million (Plavix) square feet in Montreal, Richmond Hill, E. 2008-2012: GMP issues and subsequent Toronto, Etobicoke, Mississauga, Brantford, litigation Windsor, Winnipeg, London, Calgary and Vancouver. Apotex produces more than 300 generic pharmaceuticals in approximately A. COMPANY OVERVIEW 4,000 dosages and formats which, in Canada, are used to fill over 85 million prescriptions a Background year - the largest amount of any Headquarters: 150 Signet Dr., Toronto, ON pharmaceutical company in this country. M9L 1T9 o Today, Apotex is a necessary and trusted member of Canada’s healthcare community. Employees: 7,500 (2,500 outside Canada) The company’s pharmaceuticals can be found Estimated sales: Greater than $1 billion in virtually every pharmacy and healthcare (2012 sales in Canada: ~$1.25 billion) facility in Canada and are exported to over Founded: 1974 115 countries around the globe. Export markets represent an ever growing portion of Production & development the total sales. Apotex has also established a Global capacity: 30 billion dosages per year. presence through subsidiaries, joint ventures 300 medicines in 4,000 dosages and formats or licensing agreements in Australia, 88 million prescriptions per year Belgium, Czech Republic, Italy, Mexico, Exported to 115 countries. Netherlands, New Zealand, Poland, Turkey, 600 products under development and the UK, to name just a few. Healthcare Plans to spend $2 billion over the next 10 years professionals around the world rely on on R&D. Apotex for quality and value. [Note: CapitalIQ estimates that Apotex markets Key executives products through distributors in Argentina, Dr. Bernard (Barry) Charles Sherman - Aruba, Bahamas, Bahrain, Barbados, Founder Belarus, Bermuda, Botswana, the Cayman Mr. Jacob (Jack) M. Kay - President and Islands, China, Costa Rica, Curacao, the Chief Operating Officer Eastern Caribbean Islands, El Salvador, Guyana, Haiti, Hong Kong, Hungary, Information from Apotex Home Site (2012-2013) Indonesia, Iran, Jamaica, Kuwait, Lebanon, Libya, Malaysia, Moldova, Nigeria, Our Mission: Apotex is an independent, Nicaragua, Panama, the Philippines, Russia, dynamic, Canadian pharmaceutical company Saudi Arabia, Singapore, Taiwan, Thailand, committed to R&D, manufacturing and Trinidad and Tobago, Turkey, Ukraine, the distributing a broad range of high-quality, United Arab Emirates, the United Kingdom, affordable medicines to patients, healthcare Vietnam, Yemen, and Zimbabwe; with providers, payers and governments worldwide. facilities in Australia, Belgium, the Czech We will always meet global regulatory, quality Republic, Italy, Mexico, the Netherlands, 1 New Zealand, Poland, Turkey, and the skills and experience needed to succeed in United Kingdom.] areas of sales, marketing, product o Although the company’s own business is development, clinical development, developing and manufacturing generic regulatory and medical affairs. pharmaceuticals, the success of Apotex has o Apotex has strong relationships with enabled it to diversify into a number of other regulatory agencies enabling us to develop health-related areas. The Apotex successful registration strategies in all major Pharmaceutical Group of Companies also markets. researches, develops, manufactures and o The success of Apotex has been built not distributes fine chemicals, non-prescription only on developing a broad product portfolio and private label medicines, and disposable but also in launching the difficult to do plastics for medical use. generics — taking on challenges of developing difficult APIs and formulations, Research and Development products with difficult clinical and regulatory o Research at Apotex includes the development pathways, and patent challenges. Some of our of both generic and innovative successes have been achieved in pharmaceuticals. collaboration with third parties. New generic products have been a critical o o Apotex offers a cost effective alternative to component of Apotex's growth and have potential partners who are interested in resulted in the development of substantial registering and commercializing their generic expertise in formulation development, pharmaceuticals in Apotex target markets. synthetic and analytical chemistry. o Our interest in in-licensing varies depending o Research on new chemical entities is carried on territory. We welcome you to submit your out by ApoPharma Inc., a Subsidiary of opportunity for our consideration. Apotex, where our current focus is in the areas of hematology, neurodegenerative Recent activity: 2011-2012 diseases and psoriasis. Apotex's first o October 2012: Opens offices in Saudi Arabia innovative drug, Ferriprox™, is approved in o October 2012: Divest ten older products to over 50 countries for treating iron overload in AA Pharma [Note: AA Pharma is based in Thalassemia. More recently, extensive Vaughan, Ontario; Hoovers estimates the research has begun on developing permeant company has about ten employees and annual iron chelators for the treatment of several sales of $1 million; the company states that it neurodegenerative diseases where the impact focuses on “legacy pharmaceuticals”, with a of modifying intracellular iron metabolism is product line of over 50 drugs in 2012] being studied both in animals and humans. o April 2012: Launch of Apo-Rosuvastatin Our newest area of research, psoriasis, saw (Crestor statin; AstraZeneca) ApoPharma initiate clinical trials in 2008 to o December 2011: Federal Court of Canada evaluate the safety and efficacy of a novel ruled in favour of Apotex for generic Plavix dipeptide that has demonstrated a remarkable in Canada. Apotex challenged the Sanofi- safety profile in animal toxicity testing. aventis Plavix® patents for over 8 years; o R & D expenditures for Apotex in 2007 was annual Plavix market in Canada is about over $181 million, representing close to 18% $300 million. of sales, placing Apotex in the top 10 o November 2011: Launched generic research and development companies and in Esomeprazole version of AstraZeneca's the top two pharmaceutical companies in Nexium®, a gastric proton pump inhibitor Canada (PPI). Brand product market is about $300 million per year. Apotex now offer 4 out of 5 Business Development: Partnering major gastric PPI molecules - Omeprazole, o Opportunity: Apotex offers a cost effective Pantoprazole, Lansoprazole, & alternative to potential partners who are Esomeprazole. interested in registering and commercializing o October 2011: Successful patent challenge their generic pharmaceuticals in Apotex for generic Xalatan® (eye pressure drug; target markets. Pfizer), nearly three years prior to patent o Committed to advancing generics, Apotex expiry. has been in the business for over 36 years and during that time has developed a deep understanding of the global market and the 2 Information from Hoovers (2011-2012) Apotex's overall strategy of Apotex strives to be at the apex of the continually evaluating its portfolio and selling Canadian generics industry. The company is one those medications it thinks could be better of Canada's leading generic drug makers, marketed by another pharmaceutical company. producing more than 250 generic drugs AA Pharma will attempt to boost sales of the in thousands of dosages and formulations. Its acquired prescription medications. product line includes generic equivalents Making generic versions of other companies' of Merck's Claritin (allergy medication), Pfizer's products can be a risky business. For example, Norvasc (hypertension), and GlaxoSmithKline's Apotex came into the spotlight in 2006 when it antidepressant, Paxil. Apotex markets its drugs flooded the market with a generic version throughout Canada and the US, as well as in of Sanofi and Bristol-Myers Squibb's blood about 115 other countries in the Asia/Pacific thinner Plavix (one of the world's top-selling region, Africa, Europe, Latin America, and the drugs). The two companies sued and Apotex was Middle East. The company also has a ordered to stop distribution of its generic version manufacturing agreement with The Harvard of the drug about a month after sales began, but Drug Group. the bout of competition had already had a Apotex conducts most of its business in North significant negative impact on Plavix's America, but it is expanding its global sales sales. Litigation over the matter dragged on for network through partnerships and about four years before a judge in late acquisitions. It operates across a full range of 2010 ordered Apotex to pay Bristol-Myers