Pfizer was established in 1849 in Brooklyn, New York by cousins Charles Pfizer and Charles Erhart with a loan of $2,500 from Pfizer’s father.2 Today, 167 years later, Pfizer Inc. has international revenues of $49 billion, which makes it the second-largest pharmaceutical manufacturer in the world.3 Despite Pfizer’s success, the company has faced many challenges over the last few decades. The pharmaceutical industry is heavily influenced by legal, political, and technological forces, and all indications are that the industry will continue to experience dramatic changes. Since the passing of the Food and Drug Act in 1906, the Food and Drug Administration (FDA) has had regulatory authority over drugs in the United States. The scope of its initial authority was limited and in 1938 President Roosevelt signed the Food, Drug and Cosmetic Act (FD&C) into law, which significantly expanded federal oversight of drug manufacturing and marketing.4 In addition to granting the FDA authority to mandate pre-market review of drugs, the FD&C also allowed the FDA to regulate drug labeling and advertising. Then, in 1992, Congress passed the Prescription Drug User Fee Act, which enables the FDA to collect fees from drug manufacturers to aid in funding the pre-market review process for new drug approvals.5 The effect of these reforms was significant increases in the time and cost for drug manufacturers to bring new drugs to market. In 2006, a study estimated the cost of bringing a new drug to market was between $802 million and $2 billion, depending on the type of drug being developed and the number of drugs being developed simultaneously.6 The study found that approximately 60% of the total cost of drugs was related to pre-market clinical trials required by the FDA. As inflation, increased regulation, and other factors have affected the pharmaceutical industry, a 2012 study indicated that the cost per drug for the largest manufacturers has increased to over $5.5 billion.7 For Pfizer, the total Research & Development (R&D) cost for each drug that received FDA approval was $7.7 billion between 1997 and 2011.8 The steep rise in development costs has forced many large drug manufacturers – including Pfizer – to cut R&D budgets in an attempt to control rising costs.9 The reduction in R&D funding in reaction to expanding costs has led to stifled innovation and revealed a crisis looming ahead for many large drug manufacturers in the industry. Not only have many drug companies’ blockbuster drugs gone off patent in recent years, but the reductions in R&D spending have resulted in drug pipelines that have failed to produce anything of significant value.10 The number of new drugs approved by the FDA per billion dollars of R&D expenditures has halved every nine years since 1950.11 The rapid increase in the cost of drug development and the reduction in the approval frequency of blockbuster-level drugs has led many industry experts to largely consider the current, fully integrated business model of large pharmaceutical companies to be unsustainable.12 BUSINESS AND STRATEGIES Like most large pharmaceutical manufacturers, Pfizer pursues a “blockbuster” business model that is heavily reliant on its R&D pipeline to consistently develop and launch high volume drugs – drugs with expected annual revenues of $1 billion or greater.13 In 2012, Pfizer began restructuring its operations into a new commercial operating model. Pfizer divested its infant nutrition business for $11.9 billion and spun-off its animal health unit, Zoetis. Additionally, Pfizer restructured its operations into two primary business segments: Innovative Products and Established Products. Pfizer’s Innovative Products business is further divided into the Global Innovative Pharma (GIP) and Global Vaccines, Oncology, and Consumer Healthcare (VOC) businesses.14 Ian Read commented regarding the restructuring: “This represents the next steps in Pfizer’s journey to further revitalize our innovative core. Our new commercial model will provide each business with an enhanced ability to respond to market dynamics, greater visibility and focus, and distinctive capabilities.”15 Exhibit 1 contains some useful financial comparisons between Pfizer’s Innovative Products and its Established Products. Innovative Products Business Global Innovative Pharma (GIP) Business. This business focuses on developing, registering and commercializing novel, value-creating medicines that improve patients' lives. Therapeutic areas include inflammation, cardiovascular/metabolic, neuroscience and pain, rare diseases and women's/men's health, and include leading brands, such as Xeljanz®, Eliquis® and Lyrica®. GIP has a robust pipeline of medicines in inflammation, cardiovascular/metabolic disease, pain, and rare diseases. 34% of Pfizer’s revenue growth over the past three years has come from increasing prices on existing drugs.19 Over this period, Pfizer has increased the price of Viagra by 57%, of Lyrica by 51%, and of Premarin by 41%. A 2013 study by the AARP found that the price of Lipitor rose by 9.3% in the year preceding patent expiration, and by 17.5% in 2011, the year of expiration.20 Pfizer is not alone in these practices. AbbVie and Bristol-Myers Squibb have both been reported as generating a very significant amount of their revenue growth from price increases. Drug pricing scandals and increased media and societal attention on drug pricing in general makes Pfizer’s reliance on pricing strategy to drive top-line revenue growth unsustainable. This is evident in the drug industry’s flat net pricing in 2015. Pfizer has become one of the largest pharmaceutical companies in the world primarily as a result of aggressive mergers and acquisitions (M&A). Pfizer’s acquisitions have been focused on two main strategies: expanding its capabilities and acquiring brands with strong revenues. Many of Pfizer’s acquisitions have provided new capabilities for the organization, such as biologics with the acquisition of Warner-Lambert in 2000 and biosimilar drugs with the acquisition of Hospira in 2015. Additionally, Pfizer acquired the rights to the best-selling drug Lipitor in its 2000 acquisition of Warner-Lambert and the rights to Celebrex and Bextra in its 2003 acquisition of Pharmacia Corporation. In 2016 Pfizer entered into an agreement to merge with Allergan. The $160 billion deal would have created the largest pharmaceutical company in the world and would have allowed Pfizer to relocate its headquarters to Allergan's home country of Ireland in order to take advantage of their lower corporate tax rate. 29 However, on April 4, 2016, the U.S. Department of Treasury took measures to limit corporate inversions. 30 Previously, a company realized tax benefits for inversions only when the foreign company would contribute 20% or greater of the combined company’s assets. The new ruling disregards the last three years of U.S. acquisitions by the foreign entity when determining the foreign company’s relative size under the combined entity. The new rule was the predominant factor that caused Pfizer to pay $150 million to walk away the Allergan deal.31 Pfizer would not have realized the full tax benefit of the inversion because Allergan’s relative size would have fallen below the 20% threshold under the new tax rules. Pfizer has a long history of investing in R&D for the development of blockbuster drugs. However, many industry experts believe the age of blockbuster drugs has come to an end and that new blockbusters will be rare. 32 They argue that the opportunities for revolutionary drugs have been mostly exploited, with very few areas of medicine in which breakthrough drugs can have a huge impact. In light of industry trends, Pfizer has shifted its strategy of maintaining an industry-leading drug pipeline from in-house development to being more reliant on strategic partnerships and mergers and acquisitions. To support its interest in strategic partnerships, in 2004 Pfizer founded Pfizer Venture Investments (PVI). Its goal is to identify and invest in strategic areas and businesses at the leading edge of healthcare science and technologies. PVI started with a $50 million annual budget and was Pfizer’s way of staying ahead of industry trends and investing in companies which are developing compounds and technologies that will enhance Pfizer’s drug pipeline and help drive the future of the pharmaceutical industry.33 In January 2016, Pfizer announced that it would be expanding its investment strategy to include investments in early-stage scientific innovations in immuno-oncology, gene therapy, and other cutting-edge fields. Pfizer invested nearly $46 million in four companies in these fields: BioAtla, NextCure Inc., Cortexyme Inc., and 4D Molecular Therapists, Inc. Pfizer’s strategic partnership with these and other firms provides a world-class resource in start-up organizations to accelerate the pace of scientific innovation and to help develop their pipeline of drugs. Ian C. Read was elected CEO of Pfizer in December of 2010 and Chairman of the Board in 2011, taking over from Jeffrey Kindler. Read has spent his entire career at Pfizer, starting as an operational auditor. Read’s B.S. in chemical engineering and accounting experience set the groundwork for a successful career in pharmaceuticals. Some of his previous roles included CFO of Pfizer Mexico, Country Manager of Pfizer Brazil, President of Pfizer's International Pharmaceuticals Group, Executive Vice President of Europe, and Corporate Vice President. Read also serves on the boards of Pharmaceutical Research Manufacturers of America (PhRMA), which represents the leading innovative biopharmaceutical research companies. Over the past five years, Pfizer’s revenues have been steadily decreasing, reducing net income to a five-year low of $6.96 billion. A decrease in revenue from continuing operations is the primary cause of the decrease in revenues. The spin-off of Zoetis had a compounding effect on both the decrease in revenues and cost of sales post 2013. Current assets were steady over the past three years; however, there was a recent dip in short-term investments. Goodwill is increasing, reflecting the premiums paid for acquisitions in recent years. Pfizer’s short-term borrowing has increased almost twofold in the past five years. Overall, Pfizer’s balance sheet has been fairly steady the past two years, but Pfizer’s total liabilities are slightly higher and its total equity slightly lower in 2015 compared to 2014. Both of these years are lower compared to pre-Zoetis spin-off levels. The pharmaceutical industry invests heavily in research and clinical trials and relies on obtaining FDA approval and patent protection for its products to ensure prolonged profits while the next “miracle” drug is under research. There are high payoffs when a drug is successfully brought to market; but there also great costs, in the form of massive time and monetary investments for failures, if it is not. Among Pfizer’s largest competitors are Merck, Novartis, Bristol-Myers and Johnson & Johnson. Ian Read has been at Pfizer’s helm for the past six years. With the patent expiration for Lipitor behind him, the best-selling drug in history is no longer contributing as much to Pfizer’s bottom line. Is the firm still capable of delivering a sustainable pipeline of profitable drugs, or are major changes to strategy and operations necessary? And is Pfizer’s opportunity for significant inversions over with the failed takeover attempts of both AstraZeneca and Allergan? To add to these issues, drug pricing scandals and healthcare reform have created an environment of active political reform. How can Pfizer navigate the upcoming challenges that growing societal discontent with “big pharma” and the rising cost of healthcare present? Do these threats also provide opportunities? How can Pfizer best be positioned for growth and profitability in this challenging business environment?

1. There is a lot of price pressure on pharmaceuticals companies right now, and it is likely to continue. What are some of the strategies firms (choose TWO firms) in other industries might use to reduce their costs (allowing them to reduce prices)? For each of these strategies, determine whether they are likely to be effective for a pharmaceutical company like Pfizer.

2. What are Pfizer’s options for dealing with increased government oversight and regulation? What about consumer outrage?

3. A lot of Pfizer’s growth has come from acquisitions. Would you recommend continuing this sort of growth? Why or why not?