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APOTEX, INC.1 Preparation Questions: Based on Your Reading of The APOTEX, INC.1 500 products under development Apotex reports that it plans to spend about $200 Preparation questions: Based on your reading of the million a year on R&D (about 10% of sales); in materials, together with your understanding of 2007, the company reported R & D expenditures strategies for generic drug firms, what are the key of $181 million. challenges that Apotex faces in its market segment? Canada position (2013; IMS data) Contents Canadian sales (IMS data) A. Company overview o 2015: $1.123 billion B. Apotex generic drug approvals in the US, o 2014: $1.158 billion 2001-2016 o 2013: $1.190 billion C. Example of a successful introduction (Norvasc) o 2012: $1.265 billion D. Example of an unsuccessful introduction o 2011: $1.206 billion (Plavix) o 2010: $1.354 billion E. 2008-2016: GMP issues and litigation o 2004: $785 million o 2003: $676 million Drug store sales (2015): 98.7% (balance in A. COMPANY OVERVIEW hospitals) Top five Apotex drugs in Canada (2015, Background IMS data) o Apo-Atorvastatin (generic Lipitor): Apotex is the largest Canadian-owned $97.4 million (6.1% growth) pharmaceutical company. o Apo-Esomeprazole (generic Nexium): $89.5 million (12% decline) o Apo-Rosuvastatin (generic Crestor): Founded: 1974 $41.0 million (3.2% growth) Headquarters: 150 Signet Drive, Toronto o Apo-Mometasone (generic Nasonex): Employees (2016): About 8,000 to 10,000; $39.0 million (22.6% growth) ~4,000 outside Canada (based on CapitalIQ o Apo-Omeprazole (generic Prilosec): estimates and company reports) $33.8 million (21.4% growth) Estimated sales (2016): ~$2 billion (based o Other key drugs: Apo-Clopidogrel on company reports) (Plavix; launched 2011), Apo- Risedronate (Actonel), Apo-Furosemide Key executives (Lasix; 1976), Apo- hydro Dr. Bernard (Barry) Charles Sherman – (hydrochlorothiazide; 1974), Apo- Founder metoprolol (Lopressor/Toprol XL; Dr. Jeremy Desai – President and CEO 1984) (appointed August 2014; 11 years of prior o Top 5: 27% of Apotex sales in Canada; experience at Apotex) launched 2010 to 2013. Jacob (Jack) M. Kay – Vice Chair of Board Prescriptions (2015): 86.5 million, #1 in (CEO until August 2014) Canada; 13.8% market share (2014: 84.5 million; 2013: 87.8 million; 2012: 89.2 Production & development million; 81.9 million; 2010: 85.5 million) Major segments (2015 data from IMS Canadian facilities: 3 million square feet in reports) manufacturing and R&D facilities in Richmond o Analgesics ($54 million; 2.4 million Hill, Toronto, Etobicoke, Brantford, Windsor prescriptions) and Winnipeg. o Anti-arthritics ($43 million) India: Apotex has also operated facilities in o Anti-hyperlipidemic ($165 million) Bangalore. o Anti-infectives ($81 million) Global capacity: 24 billion dosages per year. o Anti-virals ($16 million) 300 medicines in 4,000 dosages and formats o Cardiovascular ($113 million) o Diabetes therapy ($25 million) Gastrointestinal ($174 million) 1 o Prepared from public sources by Will Mitchell (updated Gastro-intestinal ($174 million) January 2017). o 1 o Hemostatic modifiers ($26 million) Research and Development o Hormones ($17 million) o Neurological ($77 million) Research at Apotex includes development of o Neurological disorders ($77 million) generic and innovative pharmaceuticals, as well o Oncology ($12 million) as biosimilars. o Ophthalmics ($6 million) Generic: Generic expertise includes formulation o Psychotherapeutics ($133 million) development, synthetic, and analytical chemistry. o Respiratory therapy ($11 million) Apotex has successfully launched multiple o Also: Bronchial therapy, diuretics, “difficult to do” generics — taking on challenges contraceptives of developing difficult APIs and formulations, Provincial sales (2015) products with difficult clinical and regulatory o Ontario ($537 million; 27% share) pathways, and patent challenges o Quebec ($148 million; 11% share) Innovative drugs: Research on new chemical o BC ($123 million; 20% share) entities is carried out by Apotex’s ApoPharma o Alberta ($121 million; 22% share) subsidiary, based in Toronto. Current efforts o Manitoba ($56 million; 27% share) include hematology, neurodegenerative diseases, o Nova Scotia ($38 million; 21% share) and psoriasis. Apotex's first innovative drug, o Saskatchewan ($34 million; 21% share) Ferriprox is approved in over 50 countries for o New Brunswick ($33 million; 22% treating iron overload in Thalassemia. Research share) has begun on developing permeant iron chelators o PEI & NFL ($33million; 24% share) for the treatment of several neurodegenerative diseases. Global presence Biosimilars: Biosimilar development is carried out by Apotex’s Apobiologix subsidiary. Exports: Apotex exports to more than 100 Biosimilars, which are the next wave of post- countries. patent competition, are new versions of existing branded biologic drugs that are reaching the end Facilities: CapitalIQ notes that Apotex has of their patents. Biosimilars are approved on the facilities in Australia, Belgium, the Czech basis that they are highly similar to the reference Republic, Italy, Mexico, the Netherlands, New product in terms of quality, safety, and efficacy. Zealand, Poland, Turkey, and the United Apobiologix, which was established in 2007, is Kingdom. based in Florida. Distributors: CapitalIQ estimates that Apotex o Apotex biosimilar approvals include markets products through distributors in Grastofil (filgrastim: biosimilar of Amgen’s Argentina, Aruba, Bahamas, Bahrain, Barbados, Neupogen) in the EU (2013; licensed to Belarus, Bermuda, Botswana, the Cayman Stada in Germany) and Canada (2015). Islands, China, Costa Rica, Curacao, the Eastern o Grastofil and Lapelga, biosimilar versions of Caribbean Islands, El Salvador, Guyana, Haiti, Amgen’s Neupogen and Neulasta, were Hong Kong, Hungary, Indonesia, Iran, Jamaica, under review by the U.S. FDA in 2016. In Kuwait, Lebanon, Libya, Malaysia, Moldova, September 2016, the Southern District of Nigeria, Nicaragua, Panama, the Philippines, Florida ruled that the manufacturing process Russia, Saudi Arabia, Singapore, Taiwan, for both products did not infringe Amgen Thailand, Trinidad and Tobago, Turkey, process patent, which expires in 2031. Ukraine, the United Arab Emirates, the United o Reported projects under way in 2017 include Kingdom, Vietnam, Yemen, and Zimbabwe. epoetin alfa (Procrit: Amgen), bevacizumab (Avastin: Roche), rituximab (Rituxin: Partnerships: Apotex offers a channel to Roche), and trastuzumab (Herceptin: partners who are interested in registering and Roche). commercializing their generic pharmaceuticals in Apotex target markets, leveraging Apotex’s Highlight activity (Apotex home site): 2011-2016 relationships with regulatory agencies in major March 2016: Launch of Grastofil, first markets. subsequent entry biologic (SEB) approved in Canada; Sandoz also launched Zarxio as a biosimilar of Neupogen in 2015 in the U.S. 2 March 2016: Generic Nasonex nasal spray 2007: Apotex was granted permission to produce (mometasone furoate monohydrate; Merck) a three-in-one AIDS drug (Apo-TriAvir) launch in the U.S. (launched in Canada in 2013), destined for shipment to Rwanda, with following a successful first-to-file Paragraph IV permission from GSK and the Canadian Hatch-Waxman challenge of the primary government. Apotex received final approval Nasonex patent in the U.S. [note: U.S. patent from the Rwandan government to distribute the courts initially ruled in favour of Apotex in drug in 2008 and made two large shipments of 2012; this decision was upheld in 2013; the U.S. the drug in 2008 and 2009. patent was scheduled to expire in 2018]; the FDA did not rule on whether Apotex would receive 180 days of exclusivity (the 2nd generic entrant, Amneal, received tentative approval from the FDA in December 2016). B. APOTEX GENERIC DRUG APPROVALS IN THE US, 2001-2016 February 2015: ApoPharma Ferriprox oral iron chelator approved in Canada October 2012: Opens offices in Saudi Arabia % of US 1st All ANDA October 2012: Divests ten older products to AA Apotex ANDA Generic approvals Pharma (in 2010, Apotex sold about 40 of its approvals ANDAs pharmaceutical products to AA Pharma) [AA Pharma is based in Vaughan, Ontario; in 2012, 2016 8 1.3% 3 Hoovers estimated the company had about ten employees and annual sales of $1 million; the 2015 16 3% 2 company states that it focuses on “legacy pharmaceuticals”, with a product line of over 50 2014 20 5% 7 drugs in 2017; in 2015, AA Pharma’s products filled about 8 million prescriptions in Canada] 2013 13 3% 3 April 2012: Launch of Apo-Rosuvastatin (Crestor statin; AstraZeneca) 2012 29 6% 12 December 2011: Federal Court of Canada ruled 2011 22 5% 4 in favour of Apotex for generic Plavix in Canada. Apotex challenged the Sanofi-Aventis 2010 5 1% 1 Plavix patents for over 8 years; annual Plavix market in Canada is about $300 million. 2009 11 3% 4 November 2011: Launched generic Esomeprazole version of AstraZeneca's Nexium, 2008 19 4% 4 a gastric proton pump inhibitor (PPI). Brand product market is about $300 million per year. 2007 23 5% 3 Apotex now offer 4 out of 5 major gastric PPI molecules - Omeprazole, Pantoprazole, 2006 17 5% 3 Lansoprazole, & Esomeprazole. October 2011: Successful patent challenge for 2005 20 6% 3 generic Xalatan (eye pressure drug; Pfizer), nearly three years prior to patent expiry. 2004 15 4% 2 2003 1 0.4% 0 Philanthropic activity 2017: Apotex provides medicine to the Mully 2002 8 2% 0 Children's Family (MCF) schools and vocational training program in Kenya. 2001 5 2% 1 2014:
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