How Much Is That Compound In The Window?

THE VALUE

In the end, it all comes down to understanding the value of your pharma asset. There are two elements to Value in the SMART questions that you must ask: What are the revenues and how do you mitigate risk and preserve and realize the maximum value.

IX. What Are The Potential Revenues Associated With This Opportunity?

In developing the revenue forecast, the answers to the questions defined earlier come together to support the financial projections of a given product assessment. This information can be broken up into four key buckets:

• Target Patients (Epidemiology, Diagnosed, Treated, Access)
• Volume (Persistence, Compliance, Dosing)
• Share (Analogs, Attributes, Adoption, Penetration, Cannibalization)
• Game Changers (Event Impact Analysis, e.g. generic entry, new launches, lifecycle management).

All come together to form the under-pinning of value. Only by diligently assessing and answering the questions noted earlier lead from a well-defined set of parameters to a well-defined forecast.

These estimates can be developed using either a top-down market forecast, which is relatively easy to generate, or a more diligent bottom-up patient based forecast that requires the diligence outlined in the previous key questions.

Once the basic revenue forecast has been generated, the forecast is further adjusted to determine the risk adjusted revenue and the risk adjusted net present value (rNPV). Probabilities of success or failure are determined based on the clinical development phase of the modeled compound and probabilities are further adjusted based on the modeled compound’s Mechanism of Action (MoA) and targeted therapeutic area. The probabilities generated are applied to the revenue forecast to reflect the risk adjusted revenue.

The most well-developed and transparent set of assumptions lead to the best accepted forecast. All forecasts are wrong, the question is to which degree are they wrong. In an opportunity assessment and a product development process that can easily involve a decade, decisions are made and values accepted on the basis of assumptions and not on the numbers themselves. That’s why transparency in terms of research and results drive the acceptance of assumptions and the subsequent statement of value.

X. How Can Risk Be Managed, Value Preserved and Resources Allocated In An Optimal Way?

Once the value is defined, the recognition of risk and the optimization of resources and increase in value begin to define the on-going process of development. In an ironic byplay of development, pharma companies look to fail earlier faster in order to distribute their limited resource allocations (resources are always limited, aren’t they?) behind products that have the best chance of succeeding in the market. At any given point of time, decisions need to be made to defer, expand, contract or abandon a project. Risk mitigation also involves identifying possible partnerships, options assessments, follow-on products and portfolio synergies – all of which need to be assessed together to preserve individual project and total value for the corporation.

Sometimes, in making investment decisions, low risk projects incorrectly get precedence over “high” risk projects simply because they appear more achievable. Yet low risk projects, in unto themselves, rarely break any innovation barriers in the market. Thus, understanding how to optimize both a given product and a portfolio’s development path becomes a crucial element in decision-making.

A key element in this analysis is laying out the clinical development uncertainty measured through asset specific probabilities of technical and regulatory success (PTRS). Unfortunately, pure financial measures penalize early assets due to huge technical and commercial uncertainty, and there is no simple financial measure to directly address this issue. That’s why it is important for companies to set optimal goals to maintain viable and healthy pharmaceutical portfolio.

A useful approach to making these kinds of decisions is developing a trade-off analysis among assets in order to identify optimal optimized portfolio scenarios. This approach moves behind stand-alone valuations that are rolled up into a single portfolio of a given value. Instead, the true value of the company’s portfolio is optimized by providing an understanding of the effect of asset interdependencies on the total value of the portfolio. It is also necessary to recognize that these values are ever-changing and dynamic as events happen, and thus, portfolio values require consistent monitoring. By adopting this approach, companies can maximize and monitor movements in portfolio value and shareholder return. In so doing, the company can optimize resource allocation across portfolio assets to maximize return and minimize risk for a given level of risk aversion. This approach will also minimize future portfolio value volatility.