Small is beautiful.. Winning in the highly competitive generics market 1 It’s not the size, it’s what you do with it that matters! 2 Presented by John Beighton 3 An entrepreneur’s dilemma How to grow without losing the “spirit” of what creates value The AMCo case study… 4 Company Origins 2010 2012 Oct 5 2012 Aug 2013 2013 May Dec Dec Management Team 6 Unique business model with industry leading margins and cash generation, replicable across geographies and therapeutic areas 7 Optimise existing portfolio and acquire niche products Acquire and develop difficult-to-make niche products which are below the radar of larger pharma companies with attractive margins and growth opportunities Leverage market knowledge Local presence in selective markets will enable successful product commercialisation (e.g. pricing, portfolio optimisation, market insight, leveraging distributor network, etc.) Apply asset light model Network of CMOs and distribution partners enables high flexibility and efficient capital utilisation, while driving costs down and securing stable long-term supply of goods and services Use low cost support Low cost Centre of Excellence for support functions in India (e.g. RA, Supply Chain, Finance, IT, Quality, HR) ensures high-quality support and cost effectiveness Unique business model underpinned by three critical enablers 8 Financial strength Cash generating engine based on asset light, highly profitable business model enables organic and inorganic growth opportunities Right size and scalable Large enough to commercialise multinational product portfolios, while staying nimble and agile Replicable business model across geographies and therapeutic areas Entrepreneurial mindset AMCo has an embedded entrepreneurial mindset with fast decision making and the ability to implement quickly 1 Global generics companies with strong presence in commodity Gx; strategic focus on specialty Gx Extent of geographic diversification Mostly Global 2 Selective globalisation beyond local markets Mostly local Mid-sized commodity generics players moving up the value chain into differentiated products and mature brands 3 Commerciallyfocused players, with primary expertise in a single market Commodity Gx 9 4 Developmentfocused co’s, finding new, local customer solutions Differentiated Gx (DGx) 5 Large R&D companies with broad range of branded innovative products being sold across the world 6 Mid-sized Specialty Pharma companies with therapeuticallyfocused innovative pipelines 7 Focused R&D players with deep expertise in specific technology platforms; limited front end presence; partner/sell products to large players for marketing/devt Branded specialty NCE / NBE Five strategic Business Action Plans (BAPs) can be derived from the overarching strategy Leverage AMCo's unique business model to expand in other attractive markets and to broaden niche product portfolio Strategic BAP 10 Description 1 Strategic Growth We will increase revenues through Portfolio Optimisation, acquisition of products and infrastructure, and through new products launches 2 International Excellence We will increase revenues through establishing direct market presence and developing internal expertise to support the International markets 3 Operational Excellence We will ensure customer satisfaction by ensuring that product is reliably supplied when required 4 Compliance and Reputation We will remain compliant and ethical with all our stakeholders, whilst also being adequately structured to support rapid growth plans 5 Integration and Culture Fast and effective integration is critical to support long-term growth and our people are key to supporting it 11 Strategic Growth • Portfolio Optimisation – registering existing AMCo products into new markets where the product isn’t currently registered or sold, and using the existing manufacturers to make the product (at least 40 submissions made in 2014) • Product Development – creating new products with a contract development partner, whereby AMCo retains full ownership rights to the product, and freedom to choose who to manufacture the product • In-Licensing – buying the rights to sell a third party’s product in a defined territory, and agreeing for the licensor to supply the product to AMCo for an agreed period of time (typically 5 years) • Product Acquisitions – buying the permanent rights to own an existing product, in a defined territory (sometimes global e.g. Fucithalmic). The seller may wish to continue making the product, but more often would require AMCo to find a new supplier within 2-3 years 12 13 Background: The In-market value chain The diagram below represents a break down of the in-country value chain and the indicated key strategic drivers / actions related to each part. I Market potential a) Sizing the opportunity b) Product selection c) Dosage / form adaption II Regulatory a) Registration of new products b) Pricing regime c) Legal frameworks III IV Coverage Sales Geographic coverage of - Hospitals - Doctors - Wholesalers Marketing Medical Promotion - by Salesforce - Controlling Salesforce / “Managing margin” - Selling discounts - Creating promotion materials - Telesales Reporting 14 V a) Specialist conferences / KOLs b) E-marketing (B2C for OTC) Data analysis VI Pricing a) Price elasticity b) Competitive environment VII Distribution a) Supply chain optimisation / no stock-outs b) Order taking / invoicing / collection c) Box shifting Global Coverage >50% of sales in UK AMCo offices/direct presence Distributor network 15 International Excellence AMCo offices/direct presence Distributor network Target markets – direct presence 16 Five Distinct go-to-market approaches for AMCo I II Market potential 1 Unmanaged box shifting 2 Strong distributor 3 AMCo Implant 4 AMCo Presence ‘light’ 5 AMCo Presence ‘heavy’ IV V Sales Coverage Marketing VI Pricing VII Distribution Distributor Distributor Joint AMCo / Distributor 3rd Parties AMCo Distributor Distributor Distributor AMCo Distributor Drivers to increase sales Additional costs 2 – More “managed service” – Higher margin to distributor Personnel costs Potential 3rd party Sales Resource 3 Broader coverage More products to market faster Price increase Volume initiatives Focus – – 2 – – – – – 3 4 – – Closer to activities Additional focus – – – Office Regulatory costs Tax implications 4 5 – – AMCo salesforce AMCo marketing – Direct labour 1 17 Regulatory III 18 Operational Excellence in an asset light context Critical Success Factors • Flexibility and having options for supply • API • Finished dosage form • Dual (or triple) sources for key products and APIs • That are registered and maintained in the MAs • That remain in a validated status • Strong Supplier Relationships • Contractual protection Results in a low risk supply chain 19 20