Ensuring Access to New Therapies in Latin America
Ensuring Access to New Therapies in Latin  America
UNDERSTANDING AND QUANTIFYING THE TARGET MARKET ATTRACTIVENESS ENSURING ACCESS TO NEW THERAPIES 2 ANALYZING MARKETS & PRIORITIZING OPTIONS 3 UNDERSTANDING AND QUANTIFYING THE TARGET MARKET ATTRACTIVENESS PRIORITIZATION & FOCUS    PLANNING EXECUTION, RESOURCES, TOOLS & RETURNS  PLANNING PRODUCT LAUNCHES IN LATIN AMERICA COMMERCIAL CAPABILITY ASSESSMENT & MANAGEMENT PLANNING FINANCIAL RETURNS ENSURING IMPLEMENTATION & MANAGING REAL OPTIONS 7 14 FIRST TIME ENTRY ENTRY THROUGH EXISTING ORGANIZATIONS INTERNATIONAL OFFICES 17
UNDERSTANDING AND QUANTIFYING THE TARGET MARKET ATTRACTIVENESS ENSURING ACCESS TO NEW THERAPIES                    2  ANAL...
ENSURING ACCESS TO NEW THERAPIES For more than 20 years we have worked and succeeded on the front-line of big organizations in the life science industry approaching and exploiting geographical expansion opportunities in Emerging Markets such as Latin America. We have successfully built new commercial presence from scratch several times in most of the Emerging Countries.   We understand the difference between those tick, desk-friendly, market reports and the value of informed decisions leading to successful implementation, the difference between abundant market data and decision-friendly, focused, relevant information. For the Latin America region we classify our wide range of consulting support to our clients in these categories: - Analyzing Markets & Prioritizing Options - Planning Execution , Required Resources, Tools & Returns - Ensuring implementation & Managing Real Options ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 2
ENSURING ACCESS TO NEW THERAPIES For more than 20 years we have  worked and succeeded on the front-line of big organizatio...
ANALYZING MARKETS & PRIORITIZING OPTIONS Both the complexity and the potential of Commercial Expansion in Latin America are often underestimated. Companies are inclined to approach these issues with nonsystematic methods, based more on perception and anecdotal understanding of the regional opportunities rather than on reality. As a result, many companies do not fully exploit the value of the regional potential even when they are capable of making the required investments. The major barriers to a systematic approach typically can be found in 1) the lack of reliable, fact-based, company-relevant market information, 2) in the difficulty of processing a large amount of heterogeneous data and 3) in the implementation flaws that often represent significant deviations from plans. Within the key components of the market understanding process, we emphasize two aspects: - Understanding and Quantifying the Market Attractiveness - Prioritization of Markets and their Segments ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 3
ANALYZING MARKETS   PRIORITIZING OPTIONS Both the complexity and the potential of Commercial Expansion in Latin America ar...
UNDERSTANDING AND QUANTIFYING THE ATTRACTIVENESS OF THE MARKETS Our process guarantees an actionable, true understanding of the regional business potential: indeed it is not based on simple multiplication of population sizes and global disease prevalences. Our market attractiveness assessment relies on two major elements: the bottomsup market potential assessment (patients and procedure-base) and a reality-based estimation of the actual acceptance for the new products and therapies that our clients intend to commercialize. Market Potential & Competition Market size is estimated using actual and local databases on disease prevalence and also considering the actual therapy delivered. Market Potentials are then obtained from both existing and upcoming competition in the framework of the existing pricing trends and the confines of reimbursement. In Latin America, special attention is dedicated to local manufacturers and IP protection. Buyers & other Stakeholders Acceptance Potentials are then modulated by the expected acceptance of the new product/therapy by Patients, Care Providers, Public or Private Payers and by the Scientific Community. When present, Patient Associations are also involved in our therapy acceptance analysis. ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 4
UNDERSTANDING AND QUANTIFYING THE ATTRACTIVENESS OF THE MARKETS  Our process guarantees an actionable, true understanding ...
PRIORITIZATION OF MARKETS AND THEIR SEGMENTS Whether our clients seek access to one country or to a region, we strive to systematize the quality of the decision-making maximizing the mid and long-term returns. All meaningful productmarket segments (PMS) are mapped and ranked following a balanced mix of standard criteria agreed with our clients (Key Prioritization Dimensions). These criteria normally include the total market value, the market share projection, the commercial and financial risk profile, the commercial and regulatory barriers, the estimated profitability and the estimated time-frame for commercial entrance. Each available segment will be thus associated to an attractiveness or emphasis score allowing the planning phase to be focused only on the high-value opportunities. This process ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 5
PRIORITIZATION OF MARKETS AND THEIR SEGMENTS  Whether our clients seek access to one country or to a region, we strive to ...
All meaningful productmarket segments (PMS) are mapped and ranked following a balanced mix of proven criteria. gives origin to the prioritized Product/ Market Matrix organizing and displaying ALL available options in a decision making friendly framework. Typical dimensions defining the Priority of each Segment Number of Patients, Procedures or treatments. Pricing and Trends. Clinical Practices influencing acceptance Portfolio cross-leverage opportunities KOL and Scientific acceptance Actual drivers for public and private payers Sales Channels: existing vs. to be constructed Opportunities or Barriers for Regulatory environment Understanding each Segment The prioritized Product/Service-Country matrix evolves over time, highlighting new opportunities and changing the relative priority of each segment while the implementation delivers the expected returns. Moreover companies need to act on each segment by, first, answering key questions: For High Priority Segment: How will the segment potential be exploited ? What financial resources will be needed ? What specific capabilities will be required ? Is the relative importance of this segment going to fall or grow ? Is Pricing going to change dramatically ? For Low Priority Segment: Will resources be withdrawn ? Is the relative importance of this segment going to change ? ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 6
All meaningful productmarket segments  PMS  are mapped and ranked following a balanced mix of proven criteria.  gives orig...
PLANNING EXECUTION, RESOURCES, TOOLS & RETURNS Once the sets of focus segments have been identified, we support our clients by preparing or facilitating the preparation of action-friendly commercial, logistic and regulatory plans ensuring that the sought top-line returns are adequately supported by a balanced mix of investments and that profitability is strongly protected. Within the key components of the planning process we emphasize: - Planning Product Launches - Commercial Capability Preparedness - Planning Reality-Based EBTDA and Cash Flow ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 7
PLANNING EXECUTION, RESOURCES, TOOLS   RETURNS Once the sets of focus segments have been identi   ed, we support our clien...
PLANNING PRODUCT LAUNCHES IN LATIN AMERICA Our approach to product launches is based on a precise set of questions: What are there market development/preparation requirements? Who and how will sell the new product/service? What is a realistic and affordable commercial channel? What is a realistic revenue generating mechanism? Are there capital expenses involved? Are there reusable and disposable items involved? When a new product or service is being evaluated, we perform all the activities that offer compelling, fact-based answers to the above questions: - Identification of the value for patients and healthcare providers - Quantification of the potential global market - Scanning of existing direct & indirect competition - Field-based verification of competitive advantage claims - Prioritization of the geographic areas - Regulatory barriers in key geographic areas - Evaluation and design of future revenue stream mechanisms ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 8
PLANNING PRODUCT LAUNCHES IN LATIN AMERICA  Our approach to product launches is based on a precise set of questions  What ...
What are there market preparation requirements ? Who and how will sell the new product ? When a new product or service is being evaluated, we perform all the activities that offer compelling, fact-based answers to the critical questions. We divide the preparation into the following focus categories: Regulatory approval/registration: In Latin America, regulatory requirements are variable and homogenization is practically absent. In all markets, except for some very rare cases, this is a gating item and no progress can be made till this is completed. Customer Segmentation The key to an effective segmentation strategy captures the difference in buying influencers/behavior within the segment.  In the complex public purchasing systems of most Latin American Countries, exploiting these differences is key to success. Value Proposition, Positioning and Pricing Development of the value of the product needs to be clearly articulated by customer segment.  This may differ significantly by segment. A well-crafted value proposition also takes into account the position of the product relative to competitive and indirect alternatives.  More than in other regions, Pricing in Latin America can be complex as it is subject to heavy and variable budget constraints: this is why we strive to focus on value based pricing. Geographic variability is a certainty in the Region:  Thinkeen has focused on assisting clients on just this point for both new and existing products. Market Development For new product launches, it is necessary to ensure that the customer base is capable of adopting the new product/therapy. As such, it may require customer education/training or other forms of implementation assistance. Demand generation involves market communication including trade shows (congresses), print/electronic collateral and on-line media. Sales Training and Preparation The sales force needs to be trained to ensure their understanding of the customer segmentation, value proposition and positioning of the new product so it can be effectively represented in the market.   The next important step is to develop a target and prioritized customer list.  Early success creates confidence and positive momentum that is hard to create any other way. 9
What are there market preparation requirements   Who and how will sell the new product   When a new product or service is ...
COMMERCIAL CAPABILITY ASSESSMENT & MANAGEMENT In the effort of accessing new Latin American markets we support both established multinational organizations enjoying their existing local organizations and small enterprises based in other regions, that are trying to gain their first access to the most appropriate distribution channels in Latin American. In both cases there is a need to build or align the commercial capabilities to the needs of the sought product/service launch. Established Organizations A successful commercialization of each new therapy, product or service requires a verification of the regional and local organizational capabilities. The complexity of the markets and the geographical distribution of commercial organizations, makes it difficult to timely align or build new competencies or re-balance the existing one to address new opportunities. We support our clients using the product-mix-based capability assessment process. This process highlights the critical gaps in an easy to understand format and enables successful implementation by organizations of any size. ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 10
COMMERCIAL CAPABILITY ASSESSMENT   MANAGEMENT  In the effort of accessing new Latin American markets we support both estab...
Small Enterprises Organizations that cannot enjoy an existing local country organization a capability assessment is needed to build the ideal new commercial channel. When our client prefers to build a direct representation we use the capability assessment process to design the commercial organization that can support the top line expectations while foreseeing future organizational developments and the acquisition of new capabilities. When our client requires to mitigate the entrance risk through the use of local distributors we use the capability assessment process to build the benchmark that we’ll use to seek the best local partner (or the best network of regional partners). For those younger companies interested in more involved support, we also make available our own capabilities through commercial & operational interim management including the set-up and management of international distribution networks. Distributor Analysis, Prioritization and Selection Process All local Life Science Distribution Companies Filtration based on criteria of Size & Portfolio-FIT All Distribution Companies with proper size and with a compatible product portfolio Filtration based on criteria of KOL Reputation and Call Point FIT All Distribution Companies with proper size, compatible product portfolio, Good KOL reputation Experience in the key Call Points Adequate Territory Coverage Filtration based on criteria of Interest Demonstrated and Long Term shareholders motivation The Two Final Candidates for Contract Negotiation ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 11
Small Enterprises Organizations that cannot enjoy an existing local country organization a capability assessment is needed...
PLANNING FINANCIAL RETURNS Actual Return on Growth Sound Financial plans are key in complex geographical expansion. No company, investor nor Board of Directors would accept and support an expansion proposal without a credible, solid, reality-based and risk-adjusted financial plan. The absence of a sound financial plan is one of the most common causes of lack of convinced and supported execution: many aspirational development plans are keeping executive teams busy but very few have really taken off and generated the expected returns. Latin America poses additional problems in relation to financial planning because of exchange rates, steep inflation, massive public tender and unexpected price cuts. ThinKeen global offers services of either auditing existing financial plans or the development of new financial plans in line with the client’s expansion options and tied to the variability of the business environment. The Classic Approach The classic approach to investment evaluation is based on unrealistic , frozen, NPV evaluations: unrealistic because they refer to one possible investment return linked to one possible way of implementing investment pro- ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 12
PLANNING FINANCIAL RETURNS  Actual Return on Growth Sound Financial plans are key in complex geographical expansion. No co...
jects. Reality is different: a range of possible returns that are dependent mainly upon the many moving and often unpredictable assumptions. Moreover , reality is different because it fortunately offers more than one course of actions (the one used to calculate NPVs) and thus the opportunity of changing future decisions tailoring them to the new set of assumptions. Our Methodology Our methodology is based on creating a strong link between reality (assumptions) and figures: a modeling approach which allows us to predict the effect of changes in assumptions and the sensitivity of the model with respect to environmental changes. We use a real-options approach allowing our clients to take informed advantage of the tree of choices offered by strategic execution. We focus on pre-Tax and Cash-flow approach vs. a simple revenue growth approach which allows our clients to make projections for the profitability of the operations and the working capital throughout the horizon. In summary our methodology is based on 3 key points: Reality Link: The strong link between reality (assumptions) and figures: A modeling approach which allows us to predict the effect of changes in assumptions and the sensitivity of the model with respect to environmental changes. We focus on performance in local currency so that we protect clients from performance misreadings due to exchange rates. Real Options: The real-options approach allows our clients to be promptly alerted when financial results suggest a change in the established growth pathway. In Latin America rapid changes in the business environment offer both opportunities for higher level of investment and the need for rapid disinvestment when regulatory or macro economic changes indicate the need of protective actions. Real Cash: A pre-Tax and Cash-flow approach vs. a simple revenue growth approach which allows our clients to make projections for the profitability of the operations and the working capital throughout the time. In Latin America we often need to temporarily move the focus from profitability to working capital and cash flow given both currency and payment terms. The mentioned prioritized Product Market Map evolves over time, highlighting new opportunities and changing the relative priority of each segment while the implementation delivers the expected returns. As a consequences the size and the profitability of each segment evolves changing the mix of sources of income. The financial models need to take in consideration this dynamics, need to match this reality-based assumptions instead of relying on aspirational goals. 13
jects. Reality is different  a range of possible returns that are dependent mainly upon the many moving and often unpredic...
ENSURING IMPLEMENTATION & MANAGING REAL OPTIONS The Entry phase is when most of consulting practices leave clients with a pat on the shoulder, a book of market research and strategic imperatives. ThinKeen follows its client organization, hand-inhand through the Entry Phase supporting a rational implementation aligned with the earlier planning phases. We all know that there is an infinite combination of entry modalities to access a new market , a new region or a new country, from the most common distribution approach , to the more involved licensing or franchising to ultimately a direct wholly owned operations. We work collaboratively sharing our proven processes with the organization facilitating capability transfer so that clients gain permanent ability to face the same issues autonomously.  We follow hand-in-hand implementation phases making ourselves accountable for milestones and results. We obviously support our clients whether they are accessing the Latin America country/region for the first time or if they already enjoy the presence of a local organization: - First Time Entry - Entry through Existing Organizations ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 14
ENSURING IMPLEMENTATION   MANAGING REAL OPTIONS The Entry phase is when most of consulting practices leave clients with a ...
FIRST TIME ENTRY For those companies entering for the first time the target LATAM market we deliver support for implementation of all entry options: Green Field, Joint Venture, Strategic Alliances, Contract Manufacturing, Franchising, Licensing, Cooperative export, Indirect Export (Distributors). Independently by the entry option chosen, we structure our support in three major areas: Research & Analysis We use our local network and institutional liaisons to select a short list of potential local partners who may become distributors, licensors or JV partners. Focus & Negotiation We guide our clients to the choice of the partner ensuring not only background screening and intelligence but also active presence during the negotiation phases resulting in actionable and mutually engaging agreements are executed. Implementation Our most valued support starts when implementations starts, resources need to be deployed, results need to be measured and gaps require to be promptly addressed. We suggest and track Key Product Indicators and anticipate changes on strategic direction when rapidly changing business conditions require action. ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 15
FIRST TIME ENTRY  For those companies entering for the    rst time the target LATAM market we deliver support for implemen...
ENTRY THROUGH EXISTING ORGANIZATIONS The control of a local commercial organization in Latin America offers a substantial advantage for companies bringing new products/services in the region. On the other hand successful product, service or therapy access often requires significant organizational realignments necessary to ensure the appropriate resources, competencies and focus are put to work. In addition to the capability assessment and realignment process we provide a set of unique tools necessary when shaping organizations around new strategic needs like new and key product launches. In particular, we provide processes to evaluate and improve commercial effectiveness and profitable redeployment of sales and marketing resources. ThinKeen Global. Grand Bay Plaza Executive Suites, 2665 South Bayshore Drive, Miami, Florida 33133 USA - thinkeen.com 16
ENTRY THROUGH EXISTING ORGANIZATIONS  The control of a local commercial organization in Latin America offers a substantial...
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INTERNATIONAL OFFICES USA GRAND BAY PLAZA EXECUTIVE SUITES 2665 SOUTH BAYSHORE DRIVE MIAMI, FLORIDA   33133 USA  1  305  2...