An Introduction to Valuations PREPARED FOR ROCKY MOUNTAIN BIOBOOSTER MAY 9 TH, 2012 An ICON plc Company
Agenda Introductions Valuation methods When is a valuation appropriate? How do you maximize your valuation? Case studies Call to action 2
PriceSpective provides an integrated approach to value strategy by offering a cohesive set of consultancy offerings Value Strategy Asset Valuation and Partnering Product Value & Pricing Strategy Value Generation & Communication Value Implementation & Evolution Business Development, In/Out-Licensing, and M&A Focus Pricing and Market Access Strategy Health Economics and Outcomes Research Price and Value Implementation The Value Continuum Value Access Price The Asset Valuation and Partnering practice utilizes the skills and experience of three related practices to deliver transaction support 3
The Asset Valuation and Partnering practice at PriceSpective focuses on creating and communicating the value of biopharma assets to support financing and transactions Advisors on the deal process for over $4 billion of transactions in the last 12 months AV&P works on both sides of the process: Strategic advisors for in-licensing due-diligence o On long-term retainer with 7/10 big pharma Advisors on commercial potential assessment and out-licensing transactions for biopharma assets o A current portfolio of several early-stage oncology and metabolic disease molecules 4
Three main approaches are commonly used in business valuations: the market approach, the income approach, and the multiples approach Approach Market Income Multiples Methodologies Market based approaches to valuation center on precedent or comparable valuations in a given market These comparisons range from competitor publically traded companies to precedent transaction values In the life science industries, market based approaches are common for early stage technologies and assets whose future revenue is difficult to project The income approach is focused on determining the current value of a future stream of potential revenue Common methodologies include risk-adjusted net present value, real options, and decision tree analyses Multiples valuation is focused on the return to investors typically venture capitalists This method most frequently sets the floor value for the up front payment (may included payments expected in the first 1-2 years) Understanding the most appropriate valuation method for your business is vital to ensuring a robust and credible valuation 5
The most appropriate method of valuation varies by company type and stage of development and are driven by value inflection points Segment Development Phase Most Appropriate Valuation Rationale IP Patent Preclinical Market Approaches Market Approaches Inability to understand market opportunity for IP, precedent transactions guide valuation Inability to understand market opportunity for early stage development products, precedent transactions guide valuation Development IND Ph1 Market and Income Approaches As product s value in the market can be defined, discounted cash flow and net present value approaches become more appropriate valuation tools over precedent transactions Product Ph2 Ph3 FDA Approved Income Approach Income Approach Efficacy data from late stage trials allows for an understanding of revenue potential through market research and analysis of analog products While a valuation may not be appropriate today, you should always be doing the things that will support a valuation at the time of a future event 6
Companies must understand a variety of key product attributes in order to arrive at credible and robust valuations Key Attributes of Life Science Products Disease Profile Budgetary Impact Market / Political Forces Product Features Body of Evidence Post- Marketing Commitments Therapeutic area Indication Ease of diagnosis Severity of disease Incidence/ prevalence Disease burden Unmet need Size of target patient population Length of treatment Cost of HTA requirements of new products Pricing and reimbursement of competitive set Level of competition Technology evaluation and trade issues Public awareness Stakeholder perception Level of innovation / meaningful differentiation Clinical and economic benefits Dosing/ route of Setting for Clinical trial designs Clinical trial data Comparative clinical evidence Health outcomes data Health economic data Expected payer value messages Patient support services Post-marketing studies Real-world effectiveness outcomes data Patient advocacy Understanding key value drivers enables companies to focus on strategic activities that will maximize their value 7
An example from Biopharma: Understanding the clinical and commercial activities that will enhance a valuation are key aspects of a transaction based business strategy Clinical Development, Regulatory Approval Process and Launch Assess Therapeutic Area & Understand Unmet Needs Develop Product Positioning Scenarios & Hypotheses Refine Understanding of Market & Competitive Environment Focus on Product Positioning & Continue Clinical- Commercial Alignment Identify Payer Stakeholders Refine Value Message Test Scenarios & Hypotheses With Key Stakeholders Conduct Pricing and Market Access Research Develop Payer Engagement and Negotiation Plan Companies must complete these activities to increase the likelihood of executing a highly favorable transaction Define Value Articulate Value Proposition Develop/Understand Value Proposition Align Clinical Program With Commercial Value Drivers Engage Interested Parties Develop Value Story Develop Supporting materials Dossier Development Execute Raise Product Deal & Therapy Area Awareness Communicate Value Story Increasing Product Value 8
$$$ By generating the appropriate evidence supporting the value proposition, a company can maximize their valuation at any given stage of development Product Value A B Break Even C PhI A Company clearly articulates the value proposition for the asset and forecasts, with supporting evidence, the value it can gain before approval PhII PhIII Approval B C Company does a reasonable job of communicating the asset s value at the time of the valuation Company does not possess the appropriate supporting evidence for the asset s value proposition and is unable to communicate its potential in a valuation 9
Audience Examples Opportunity Assessment Framework Disease Profile Budgetary Impact Market / Political Forces Product Features Body of Evidence Post- Marketing Commitments Therapeutic area Indication Ease of diagnosis Severity of disease Incidence/ prevalence Disease burden Unmet need Size of target patient population Length of treatment Cost of HTA requirements of new products Pricing and reimbursement of competitive set Level of competition Technology evaluation and trade issues Public awareness Stakeholder perception Level of innovation / meaningful differentiation Clinical and economic benefits Dosing/ route of Setting for Clinical trial designs Clinical trial data Comparative clinical evidence Health outcomes data Health economic data Expected payer value messages Patient support services Post-marketing studies Real-world effectiveness outcomes data Patient advocacy 10
Seek, understand and articulate the most appropriate valuation method for your preferred exit strategy Overall Goal Technical, clinical, and commercial activities should be aligned to support and maximize a valuation that is most appropriate given a company s exit strategy Key objectives 1 2 3 4 Develop credible information about market opportunities Continue development as long as what you re generating creates differentiation that will drive value Align your external communication to your business strategy; e.g. socialize your opportunity to create value or stealth mode to inhibit competition Generate the clinical and commercial data that will support a valuation at the time of a future event 11