Early-Stage Valuation in the Biotechnology Industry

Biotechnology (or biotech) has impacted almost every aspect of human life. It has reorganized industries, drastically changed healthcare, helped to improve the environment, and led to important changes in laws and ethical norms.

Among the various biotech fields, medical biotech has been by far the most influential, beneficial, and controversial. It has generated not only superlative discoveries to improve the lifespan and quality of human life, but also the greatest amount of wealth for all the players involved, and the greatest volume of public debate.

Several important trends are shaping the future of the pharmaceutical (or pharma) and biotech industries. The biotech industry is characterized by the presence of strong clusters in all countries. The pharma and biotech industries are experiencing an outsourcing phenomenon, mainly due to a lack of in-house expertise and efficiencies. Diagnostics and therapeutics are increasingly converging, a trend that will lead to predictive and precise diagnostics and personalized and preventive medicine. The first few years of the twenty-first century have witnessed significant changes in the pharma/biotech alliance landscape. Today we are seeing the “omic”-ization of the biotech industry: most of the emerging technologies are genomics, proteomics, cellomics, and pharmacogenomics. In addition, the biotech industry faces uphill ethical issues, including excessive marketing, third-world drug availability, genetic engineering, stem cells, and cloning.

The medical biotech industry faces several challenges. First, science, the human body, and disease are, essentially, complex. Second, unlike other high-technology industries, the biotech product development cycle is very long, even after proof of concept. Biotech projects take between ten and twenty years to become successful and cost over $200–300 million before a product reaches the market. Third, delivery of most biotech products and therapies is complex and can be painful, often involving intravenous delivery. Fourth, the preceding three factors pose significant challenges for research and development (R&D) financing. In addition, there are certain outside determinants that influence the biotech industry, including regulation, demography, reimbursement climate, and big pharma companies.

Stem cell research is one of the most fascinating areas of biology, but it raises questions as rapidly as it generates new discoveries. The greatest potential application of this research is the generation of cells and tissues that can be used for cell-based therapies. A stem cell is a special kind of cell that has a unique capacity to renew itself and to give rise to specialized cell types. Through the process of differentiation, stem cells form various tissues and organs, and the combination of these differentiated materials develops into the whole human body. This class of human stem cell holds the promise of being able to repair or replace cells or tissues that are damaged or destroyed by many of our most devastating diseases.

Diabetes mellitus is a group of diseases characterized by high levels of blood glucose resulting from defects in insulin production, insulin action, or both. Diabetes mellitus is a type I diabetes—also called juvenile-onset diabetes or insulin-dependent diabetes—and develops when the body’s immune system destroys pancreatic beta cells, the only cells in the body that make the insulin that regulates blood glucose. Type II diabetes, also called adult-onset diabetes or noninsulin-dependent diabetes, may account for 90–95 percent of all diagnosed cases of diabetes. There are more than 194 million diabetics worldwide, with this number expected to exceed 333 million by 2025.

Insulin is currently the most effective drug for controlling hyperglycemia and is widely accepted as the gold standard for treating type I diabetes and even late-stage type II diabetes. However, physicians and patients are reluctant to use insulin until other less effective drugs have been attempted. This is mainly because insulin therapy is invasive and painful: patients must take insulin intravenously.

One of the most promising ways to cure diabetes is to restore the function of islet cells biologically, either through islet cell transplantation or by engineering cells to restore the insulin secreting function. Islet transplantation, a procedure that can restore insulin production in patients, is a highly promising area of research.

Based on analysis of stem cell research, diabetes market opportunities, and the development of stem cell therapies, it is possible to place a value on a company in the early (preclinical) development stage of a stem cell therapy for diabetes. Such an exercise involves valuing a company based on three different approaches—(1) the discounted cashflow model, (2) the royalty or licensing model, and (3) the comparables valuation model. Sensitivity analysis based on market, pricing, costing, R&D, and development stage can further lead to precise valuation range for a given company.

For biotechnology companies, various drivers play a critical role in company valuation, including people (management team), alliances and partnerships, intellectual property rights, R&D and technology, funding and financing, market opportunity, and therapeutic area.