شمارش جوجه ها قبل از تخم ها: ارتباط پرتفوی توسعه محصول جدید با انتظارات سهامداران در بخش دارویی

Drug development is the lifeblood of pharmaceutical firms and a critical source of innovation in the healthcare industry. Pharmaceutical firms maintain their competitiveness by continuously developing and introducing new drugs, which requires an efficient new drug portfolio management process. However, the current literature does not elaborate on strategies pertaining to these new drug (product) portfolios (i.e., portfolios of drugs under development), nor does it provide the means with which to understand the future cash flow-generating potential of these portfolio strategies. To address this problem, we propose a set of generic descriptors of new drug portfolio strategies (i.e., portfolio breadth, portfolio depth, blockbuster strategy, and stages of the drug development process) and relate these descriptors to Tobin's q, a forward-looking measure of shareholder expectations. The results of a latent class regression analysis show that shareholder expectations of firms with broad new drug portfolios and potential blockbusters are positive. For most firms, shareholders focus on the final stage of the drug development process and deemphasize portfolio depth. In contrast, for a minority of mostly small firms, shareholders seem to value the earlier stages of the drug development process and stress portfolio depth.

Considering that healthcare expenditures constitute 8–15% of the gross domestic product in most developed countries (Shankar, 2007), research advancing the management of healthcare and life science technologies is considered vital for progress. The pharmaceutical sector has grown more than any other component of the healthcare industry, both in terms of expenditure and innovation. Consequently, proponents of healthcare innovation increasingly focus on the pharmaceutical sector, a major source of advances in life science and healthcare technologies. The pharmaceutical sector is expanding at a remarkable rate, with global sales increasing from $317 billion in 2000 to $550 billion in 2004 (Trombetta, 2005). Much of the growth is sustained by the continuous introduction of new products addressing diseases in desperate need of remedies. The development of new drugs is the lifeblood of most pharmaceutical firms, and it is no wonder that pharmaceutical firms spend approximately 20–30% of their revenues on research and drug development. However, managing the development of new drugs in the pharmaceutical industry remains extremely challenging due to the complexities of the development process and government regulations. Drug development is also costly, costing $800 million–$1 billion per drug, and extremely risky, as only 1 in 50,000 chemical entities generated in the earliest stages of development ultimately qualify as a new drug candidate that moves into the later stages of development. In addition, the development time of a new drug is quite lengthy (10–12 years on average), as each drug must clear multiple stages during the development process. The multiple stages of the drug (product) development process in the pharmaceutical industry comprise the following: in silico and in vitro analyses identify a potential drug candidate as a treatment for a given disease, after which preclinical animal tests are conducted. If the preclinical tests yield promising results, the firm files an application with the Federal Drug Administration (FDA) to test the drug on human subjects through a series of clinical trials. The clinical trial stage comprises three phases. In phase I the drug is tested in a small number of healthy human subjects for safety; in phase II the drug is tested for efficacy and potential side effects on an average-sized sample of a few hundred patients; and in phase III the drug is tested for dosage guidelines and a detailed clinical profile using thousands of patients is established. Finally, the test results are submitted to the FDA for evaluation and possible approval. In increasingly risky industry environments, such as the pharmaceutical sector, firms turn to portfolio management to develop new products and maintain sustainable competitive advantages and long-term profitability (Cooper, Edgett, & Kleinschmidt, 2004). Specifically, new product portfolio management, defined as a “dynamic decision process, whereby a business' list of active new product projects is constantly updated and revised,” optimizes resource allocation among new product projects at various stages of development and is aimed at diverse markets (Cooper, Edgett, & Kleinschmidt, 1998, p. 3). The management of a portfolio of new drugs under development, otherwise referred to as a new drug portfolio, remains one of the most important components of the corporate strategy of pharmaceutical firms. However, portfolio management successes have been adequate at best ( Slade, 2006), and it should come as no surprise that many firms, including pharmaceutical companies, struggle to assess the revenue-generating potential of their portfolio strategies. The challenge in assessing portfolios of new products under development stems from their valuation, which can refer only to expected future income; new product portfolios themselves do not generate any current income. Furthermore, it is impossible to assess portfolios on the basis of their historical performance — akin to counting chickens before the eggs hatch. Unfortunately, no objective measures of the future revenue-generating potential of new product portfolios exist, though such measures would represent powerful tools for distinguishing among new drug portfolio strategies. Decisions regarding individual projects often rely on a net present value analysis to make go/no-go decisions for product development projects. Although similar techniques could be adapted for portfolios, incorporating synergies and complementarities would be difficult, and managerial judgments regarding revenues, expenses, and synergies across the projects in a portfolio would remain necessary, which means judgment biases would still exist (e.g., Sharma & Lacey, 2004).1

Our exploratory research describes new drug portfolio strategies in terms of portfolio breadth, portfolio depth, blockbuster strategy, and the stages of drug development. We also argue that shareholder expectations in Tobin's q are forward-looking, because they reflect financial market sentiments about the future streams of cash flow accruable to company strategies, such as new drug portfolio strategies (see Table 6 for a summary of this research). Overall, shareholder expectations of a firm's future cash flow potential relate positively to a wide portfolio that targets multiple therapeutic categories. A blockbuster strategy also appears important, as indicated by its positive association with Tobin's q. Shareholders recognize interfirm differences and alter expectations across firms accordingly. For most firms in our sample ( Regime 1), shareholders assign importance to broad portfolios that target multiple therapeutic categories in the later stages of development, but they prefer a limited number of diseases to be targeted. However, for 31 firms ( Regime 2), shareholders make positive associations with a broad portfolio targeting multiple therapeutic categories and few diseases, though only in the earlier stages of the drug development process. In addition, shareholders in these firms emphasize greater portfolio depth with considerable variability in the number of targeted diseases across the therapeutic categories.