Recomendations Report Pfizer
Recomendations Report Pfizer
Recomendations Report Pfizer
TABLE OF CONTENTS
Executive Summary... Introduction ....... Strengths. Barrier to Entry. Mature Market.. Strongest Revenue Among Competitors.. Highly Diversified Product Base.. Weaknesses ... Prone to Lawsuits. Excessive Comarketing Rapid Expiration of Patents. Opportunities . Expansion of Research and Development. Safeguarding Against Lawsuits. Threats ... Catastrophic Loss of Consumer Confidence. Catastrophic Regulation Change... Catastrophic Failure to Innovate... Recommendations . Restructuring Research and Development Categories and Classifications of Priority Research. Expansion of Generics.. Conclusion..
i 1 1 1 2 3 3 3 3 3 4 5 5 5 6 6 6 6 6 7 7 9 9
List of Illustrations Figure 1 Figure 2 Figure 3 Figure 4 Pfizer Stock: September 2010-2012 Pfizer Expenditure Pie Chart... Amount of Prescription Painkillers by State... Heart Disease Death Rate by County: 2000-2006 2 5 8 8
EXECUTIVE SUMMARY
Recommendations Report for Pfizer Inc. By Martin Bammes Research and development is the cornerstone of the pharmaceutical industry. Pfizer, being no exception to this, spends a vast majority of their retained earnings on the production of successful drugs. Some of these drugs like, Lipitor, Viagra, Chantix and Zoloft mass billions of dollars in profit and secure Pfizer as the mainstay of the industry. Unfortunately, profit of this scale is almost never guaranteed due to a short patent lifespan and maintaining a new product line is extremely difficult because of the changing need within that patent window. Still, Pfizer make leaps and bounds on a quarterly basis to ensure that it does produce and revamp products continuously. Pfizer maintains itself within one of the most mature markets with the highest barriers to entry, causing it to become the industry leader by several billion dollars over the nearest competitor Johnson & Johnson. However, the company faces continuous multi-billion dollar lawsuits that can single handedly destroy an entire product line and thousands of jobs with it. Another weakness of the company would be it susceptibility to the catastrophic loss of patents, known as a patent cliff, all at the same time. An example of Pfizers patent cliff situation would be the loss of Lipitor, Viagra and Zoloft all within a few years of each other. The loss of these multi-billion dollar winning drugs, also known as blockbuster drugs, pose significant threats of revenue rushing to competitors like Merck. Fortunately, Pfizer can afford and should expand research and development in the following fashion: break R&D into subdivisions based on key demographics for consumers, second, to prioritize these subdivisions for different classifications of pharmaceuticals based on their price elasticity. By doing this, Pfizer can accurately fund more lucrative programs such as, heart medications, antidepressants and painkillers within its desired geographical region. By expanding and subdividing R&D, Pfizer will have a more advanced distribution system along with a cost effective research base, causing undesirable competitors to fall behind. Pfizer will then win considerable amounts of market share and be able to make adjustments to drug trials and patents with more transparent sections of development. Moreover, Pfizers new research departments will have considerably safer clinical trials, resulting in the retention of several billion dollars.
Strengths
The pharmaceutical industry itself has an extremely high barrier to entry, resulting in a very mature market. PFE is the leader of that industry, amassing billions of dollars in revenue and becoming a mainstay in American infrastructure. The company maintains this position by developing a diverse product base that can withstand competition from even the strongest pharmaceutical enemies in existence.
Barrier to Entry Pfizer Incorporated (PFE) and their competitors have created one of the largest industries in the world grossing 98.9 billion dollars,1 creating an almost impossible to enter market. Pfizer alone is the industry leader in revenue, making them the strongest of the high barrier industry. They secure this position with a myriad of business tactics that include: assimilation of weaker competitors, shared contracts with competitors with more desirable products, an internationally diversified market base, and one of the strongest research and development departments in the industry. Pfizer is a multi-billion dollar industry with steady, sometimes rapid, growth and a solid commitment to fiduciary responsibility. As a result, even well-funded pharmaceutical operations do not stand a chance against this drug giant. The second largest contributing factor to the barrier is the strict regulations all pharmaceutical manufacturers must follow. In the United States the regulatory agency in question is the Food and Drug Administration (FDA). The FDA is partially responsible for a drugs Hippocratic responsibility; a drug must help more than it hurts. Forcing drugs through the clinical trials required by the FDA costs millions, sometimes billions of dollars and only the extreme players can afford the overhead on such operations. Ultimately, the Food and Drug Administration has the industry in its pocket and may decide, through regulatory means, which company stays in the American drug market. Mature Market Pharmaceutical research is one of the most mature markets in our infrastructure. Next to central banking, civilized society will always need the science of life saving pharmacology. This natural order dictates that, in a capitalistic society, prices of pharmaceuticals are extremely inelastic. Pfizer Inc. knows that lifesaving drugs can be a write your own ticket industry, explaining why they deal overwhelmingly in what I call, Last resort drugs. Research and Development is the mainstay in Pfizers ability to produce these last resort dugs in a way that solidifies not only the position of the industry, but the position of the company as well. This market is considered to be a mature market with complete saturation. In her industry report, Sophia Snyder states that a mature industry as, Revenue grows at same pace as economy Company numbers stabilize; M&A stage Established technology & processes Total market acceptance of product & brand Rationalization of low margin products & brands.2 This means an industry is a direct representation of the economy and technological innovation can have an immediate effect on the marginal cost curve of a firm. As a result, Pfizer Inc. can, hypothetically, move an economy or vice versa, equally. 3
Sophia Snyder, Brand Name Pharmaceutical Manufacturing in the US IBISWorld Industry Report, August 2012, p. 4, IBISWorld, accessed on October 24, 2012.
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Snyder, p. 35 (Refers to the same work by Snyder cited in full in an earlier note.) Pfizer Histogram, StockCharts.com, 2012, accessed on November 7, 2012
Figure 1: Pfizer Stock September 2010-2012 Strongest Revenue among Competitors The financial reports of Pfizer Incorporated state that their revenue for 2011 was 67.425 billion dollars with total stockholders equity over $82bn.4 This alone puts PFE far in the lead of their nearest competitor, Johnson & Johnson, with 15.2% market share.5 With a strong revenue stream, such as the one held by Pfizer, they have the ability to further retain earnings into research and development, ultimately undermining threatening companies like Merck and GlaxoSmithKline. 6 Highly Diversified Product Base Pfizer Incorporated can be found in the deepest corners of the pharmacy. A common place for their ventures is in rare prescriptions for exotic disorders, yielding high returns and low competition. According to Pfizers web site, the company also hold patents on fundamental products like Bicilin, a core antibiotic administered to millions of patients.7 PFE currently has two hundred and seventeen product patents and hundreds more on ways to administer them. This diversification of a product line is the reason why they are such a stable company.
Weaknesses
Pfizer is constantly battling three failures of its practice: lawsuits, comarketing, and patent expiration, more commonly known as, patent cliffs. Currently these weaknesses are fueled by a general neglect of research and development and prove to hinder PFEs upward mobility. Prone to Lawsuits On September 2, 2009, Pfizer settled the largest fraud case of its kind at $2.3 billion preceded by a $1.42 billion settlement that January, all after their $430 million settlement the year before.8 Pfizer Incorporated is engaged in so many lawsuits, they have a notation for it on their cash flow statement. Needless to say, PFE throws away enough money to build entire subsidiary companies. This business practice is caused by forcing products through the FDA before completing thorough clinical trials and sometimes circumventing the system entirely. As a
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Pfizer Inc. Balance Sheet, http://www.mergentonline.com/basicsearch.php, accessed on October 20, 2012. Snyder, p. 4, (Refers to the same work by Snyder cited in full in an earlier note.) 6 Pfizer Histogram, StockCharts.com, 2012, accessed on November 7, 2012 7 Pfizer Products, Pfizer.com, 2012, http://www.pfizer.com/products/#A, accessed on October 29, 2012. 8 Mark Ratner, The Largest Fraud Suit for Off-Label Promotion, Nature Biotechnology, Vol. 28, September 2010, Business Source Premiere, EBSCOhost, accessed on October 24, 2012.
result, Pfizer has made themselves a target for law-firms across the country, leading them into the variable cost of settlements. These lawsuits represent a weakness particularly in R&D. Modern medicine needs to be the lifesaving force of the twenty-first century, and if they want to make money, it needs to be provided by PFE. However, these innovations can only take place legally and after the pharmaceuticals pass all levels of clinical trial. With the money lost in settlements of these kinds, Pfizer can expand R&D with millions left over for retained earnings and dividends to investors. Excessive Comarketing When Pfizer Inc. comes across a superior product with an inability to own it, they merge or share with the owning firm. This does not only take money away from research and development; but also, puts Pfizer in a situation to be a retailer instead of a manufacturer. Often what happens is two identical drugs must engage in a price war for market share. Another comarketing strategy Pfizer is often guilty of is selling valuable assets, like their $12 billion sale of patented baby formula to Nestle,9 according to Jacob Steinberg. Because of this, PFE makes itself vulnerable to loss of market share and diversity.
Rapid Expiration of Patents The greatest weakness PFE has is the time limit on their most profitable drugs. It is the utmost responsibility of the research and development department to constantly innovate and reassess new drugs to fulfill their fiduciary responsibility; however, Pfizer has recently lost the patents to their three blockbuster products: Zoloft (Sertaline) is a monoamine oxidase, (MAO) inhibitor designed to delay synapses of serotonin in the brain similar to flooding a car engine with gasoline in order to get a car started.10 The end-state would be a more docile person that would be more difficult to upset. Due to the vast majority of Americans facing the diagnosis of depression in the late 90s and 2000s, Zoloft gave Pfizer revenues necessary to corner market share for nearly all psychological medicine. Lipitor (Atorvastatin) is a HMG-CoA reductase inhibitor, (cholesterol blocker) designed to prevent heart attack in extreme high-risk patients. 11 Because of an ever more increasing obesity percentage in America, Lipitor seemed to be the perfect fit for a marketing revolution in cardiology. According to Fierce Pharma Lipitor made Pfizer a record revenue of $12.5 billion.12 This was the chief cause of the companys success.
Jacob Steinberg, What Will Pfizer Do With Its Newly Acquired $12 Billion? Seeking Alpha, April 24, 2012, http://seekingalpha.com/article/521351-what-will-pfizer-do-with-its-newly-acquired-12-billion, accessed on October 29, 2012 10 The American Society of Health-System Pharmacists, Sertraline, PubMed, April 13, 2012, http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001017/, accessed on October 29, 2012. 11 The American Society of Health-System Pharmacists, Atovastatin, PubMed, April 13, 2012, http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000009/, accessed on October 29, 2012. 12 Lipitor, Feirce Pharma, October 9, 2012, http://www.fiercepharma.com/special-reports/lipitor-1, accessed on October 29, 2012.
Viagra, (Sildenafil) is a phosphodiesterase-5 inhibitor that became the most publicized and counterfeited drug in history. It is designed to treat erectile dysfunction but has also been prescribed for individuals with high blood pressure to enable exercise for chronically obese people.13
These three drugs are responsible for billions of dollars in profit, spanning over the last decade; unfortunately, all of these drugs now have less expensive generic counterparts. Consequentially, Pfizer has no means of generating the same accelerated growth represented by the last ten years.
Opportunities
Expansion of Research and Development Pfizer Inc. has the means and opportunity to expand their R&D department to the necessary levels required to create safe marketable products. According to Pfizers financial reports, largely due to outstanding litigation, PFE has accumulated almost $35 billion in long-term debt.14 The safest way to resolve that debt without selling the company would be to expand R&D to productive levels above their competition.
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Figure 2: Pfizer Expenditure Pie Chart The companys R&D is currently operating at a very lean capacity in preparations for the upcoming shift in the health industry known as, Obamacare. Because of the condition this caused, Pfizer has a unique opportunity to show its true strength when it comes to research in medicine. Most big drug companies are cutting down on R&D; therefore, expanding the research into new areas would undermine Pfizers competitors at a time when they are most vulnerable.
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The American Society of Health-System Pharmacists, Sildenifil, PubMed, September 15, 2012. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001046/, accessed on October 29, 2012. 14 Pfizer Inc. Balance Sheet, http://www.mergentonline.com/basicsearch.php, accessed on October 20, 2012. 15 Summary Q1-Q2 2012 Payments to HCP in Millions of $, Pfizer.com, 2011, http://www.pfizer.com/responsibility/working_with_hcp/footnote/2012/footnote_2012.jsp, Google Images, accessed on November 1, 2012.
Safeguarding against Lawsuits Pfizers utmost priority in reducing cost is to create more efficient, safer, products. Only through the streamlining of pharmaceuticals to acceptable levels of probable error can PFE expect to reduce the number of costly court battles. Anne Monroe explains in her report that, in the frame of R&D, this takes the form of higher qualifications for clinical trials, particularly in phase three when drugs are tested on hundreds of human patients.16 Clinical trials can last years to decades depending on the severity and the length of treatments, which is why Pfizer must take center stage in research instead of freeriding on the coat-heals of independent labs.
Threats
Catastrophic Loss of Consumer Confidence The first threat to Pfizer Inc. is the risk of catastrophic loss of consumer confidence. Customers of Pfizer are continuously barraged with media about fraud and the potentially harmful drugs they produce. Because of this, doctors and patients might start deliberately avoiding Pfizer as a whole in fear of side effects associated with their products. Second, competitors may start advertising campaigns similar to Pfizer, resulting in a dramatic loss of market share. Catastrophic Regulation Change The Affordable Health Care Act of 2010 has been calculated to have a serious impact on the pharmaceutical industry. When the act takes effect in 2014, approximately thirty million more people with have access to health insurance giving the insurance industry increased negotiation power over drug prices. In his article, As Obama-care Dawns, Big Pharma Rides into the Sunset, Dr. Daniel R. Hoffman explains that by vast majority Pharmaceutical CEOs are calm about the implementation of the Affordable Care Act, while at the same time laying off hundreds of research and development employees.17 In the article, Top Ten Pharma Layoffs of 2011, Ryan McBride and Mark Holmer says, On February 1, 2011, Pfizer's job cuts in New London, CT, and Groton, CT, could total as many as 1,100 over 18 months, and the planned closure of Pfizer's lab in Sandwich is expected to claim as many as 2,400 jobs.18 (Top Ten) This could have lasting paralyzing negative effects on Pfizer because the lack of R&D would result in a lack of new drugs. Catastrophic Failure to Innovate Ultimately the greatest failure of any producer is to stop producing. Pfizer Inc. has lost their patent on their blockbuster medications and they have nothing worthwhile to replace them with. They have hundreds of marketable products; however, Pfizer is not going to cover several billion dollar losses if it does not have Lipitor. This could
16 17
Anne Monroe, Clinical Trials Explained, Acria, 2012, Google Scholar, accessed on November 1, 2012. Daniel Hoffman, As Obama-care Dawns, Big Pharma Rides into the Sunset, Philly.com, September 20, 2012, http://www.philly.com/philly/blogs/healthcare/As-Obamacare-dawns-Big-Pharma-rides-into-the-sunset.html, accessed on October 29, 2012. 18 Ryan McBride, Mark Holmer, Top Ten Pharma Layoffs of 2011, Fierce Pharma, January 4, 2012, http://www.fiercepharma.com/special-reports/top-10-pharma-layoffs-2011, accessed on October 29, 2012
cause a huge loss in stock price and ultimately shareholders. Failure to innovate new blockbuster medicines soon could feasibly end Pfizer Incorporated. This is where R&D must be the ground zero pharmaceutical development. Pfizer can and must, fight to be the first developer in new medicine, by seeking out the brightest bioengineers and physicians that do force drugs through clinical trials but adapt to them.
Recommendations
Pfizer incorporated can generate accelerated growth if it is willing to undergo two changes. First would be a systematic restructuring of research and development. The second is to expand said departments in chosen locations for optimum efficiency. The restructuring of how the company produces new medicine can be broken down into priority categories. This would realign focus on producing blockbuster medications. Restructuring of Research and Development Research and development is the most complicated sector of the pharmaceutical industry. It is the intention not to create profit immediately, but rather, several years in advance. Unlike other industries, drug companies must exploit evolving human conditions within the time frame of a patent. Because of this, Pfizer must have strong insight to create drugs for tomorrows diseases. The good news is that most human conditions are extremely predictable, and Pfizer can create and sustain growth by restructuring its research and development department. The department can prioritize research in easily broken down groups, catering to afflictions that have become standard in contemporary American society. The groups can be easily identified as: obesity and chronic developmental medications, self-fulfillment medications such as anti-depressants and sexual stimulants, and prescription drugs with high potential for abuse and dependency. The reason why drugs can be broken down into these priority groups is because these drugs obviously have better earning potential and less liability than the life prolonging medications associated terminal care drugs like, Revlemid and Dexamethasone. Categories and Classifications of Priority Research For all intensive purposes, there are five classifications of medication. The first one is generic herbal medicine. These drugs can be commonly found in over the counter, (OTC) specialty stores. The second is OTC pharmacy oriented drugs. These can include all drugs excluding antibiotics and any other medicine requiring a prescription. Third are prescription nondependent drugs that would be prescribed independently from other medications and typically cure symptoms with no reliance on repeat service. Fourth would be the prescription dependent drugs that would depend on a patients chronic need. The fifth and final priority classification is last resort drugs. Last resort drugs are highly dependent, extremely expensive medicines designed to prolong life weeks, months, or years, but often have permanent and terminal side effects on the patient. Most of Pfizers blockbuster drugs have fit into the third or fourth classifications under this concept, and it is in the best interest of the company to use research resources to prioritize the replacement of such
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medicines reaching their patent cliffs. As earlier in the report, the main drugs that need replacement are: Lipitor, Zoloft, and Viagra. These three blockbuster drugs all come from the third classification and serve as a cornerstone of Pfizers revenue. With the classifications of drugs there is also an inherent key demographic for R&D. That key demographic is the most likely afflictions facing the market within the time frame of the next patents. Currently the leading conditions are heart disease, diabetes, and various other developmental lifestyle based illnesses. R&D must focus on these conditions in order to secure blockbuster profit. Lipitor is still the most effective treatment for high cholesterol, but it cannot generate revenue as fast as it did within its patent lifetime. As a result, it is in the best interest of Pfizer to recreate the cholesterol fighting drug. According to Andrew Pollack of the, New York Times, To the surprise of many cardiologists, a controversial alternative therapy proved beneficial to people with heart disease, reducing the rate of death and cardiovascular problems in a clinical trial.( NYT) The alternative therapy he is speaking of is chelation therapy. It has failed many clinical trials, but there is reason to believe that there will be a breakthrough in its development soon. When chelation therapy passes the third phase of clinical trials it will be available for a patent that could win devastating market share heart disease. Chelation therapy, being the end state treatment of heart disease, could work with the later stages of Lipitor patients, replacing the OFC treatment with the profitable lifesaving infusions. 19 20 After the lab closing in Sandwich Germany last year, Pfizer operates out of five American laboratories and on British facility. The facilities are as follows: California, Connecticut, Missouri, UK and New York. These facilities run some unique, but mostly similar production models. This is a mistake. As seen in figure eighteen, Pfizer could prioritize cardiovascular research in its Missouri based location as the highest density of heart disease is in the south. Meanwhile, the company could focus on generics and painkillers on the west coast due to its high density of prescription drug abuse.
Figure 3 (Left): Amount of Prescription Painkillers by State Figure 4 (Right): Heart Disease Death Rate by County: 2000-2006
19
CDC, The Amount of Prescription Drugs in the United States Varies, CDC.gov, December 19, 2011, Google Scholar, accessed on November 11, 2012. 20 CDC, Heart Disease Death Rates 2000-2006 Adults Age 35+ By County, CDC.gov, September 18, 2012, Google Scholar, accessed on November 11, 2012.
In order to properly provide for the needs of Pfizers consumers, it must seriously investigate the production of highly addictive and overprescribed drugs. Prescription pain killers and psychological stimulants such as Adderall must be set into the foundation of R&D, because there can be no guarantee of sustained profit without loyal consumers. Pfizer can also easily produce new pain killers similar to Oxycodone that are often abused with an extremely high demand. Celebrex is Pfizers cornerstone when it comes to prescription pain medications and it is only to be outdone by the new Lyrica, a strong pain killer designed for fibromyalgia. Now Lyrica is being used to treat spinal cord injuries, but shows strong promise in the market of dependency forming drugs. This is an example of where Pfizer should be pooling it resources. Pfizer still has a problem if it were to re-divide all it laboratories, and this has to do with reinstating the laboratory in Germany. Germany, being the leading engineering and scientific capital of the world, shows promise when it comes to oncology and stem cell research. A laboratory in Europe can also operate free from American stem cell regulation while having the higher standards of clinical trials demanded by last resort medications such as cancer treatments. Expansion of Generics The pharmaceutical industry as a whole is shifting closer to the impending socialization of medicine. The Affordable Healthcare Act will be in effect in 2014, resulting in a wave of generic prescriptions. Johnson & Johnson stands as Pfizers greatest threat in this situation because, as a company, PFE primarily deals in higher end, expensive treatments. It is the second highest priority of R&D to produce generic and OTC drugs, because where Pfizer cannot make money with quality, it must make up in quantity. According to Sophia Snyders industry report, Pfizer has 15.2% market share.21 PFE could win a substantial portion of Johnson & Jonsons business if it were to produce more OTC products like multi vitamins and first aid products like petroleum jelly. Conclusion Pfizer Incorporated has a distinct opportunity to expand and prioritize research and development. The prioritization of drug research will gear Pfizer back into the best market position by focusing on their key demographic. It has also been concluded that, expansion into more OTC products can secure future profits. Even though PFE is the strongest in the pharmaceutical industry, the company can and should make these necessary changes to R&D for the purposes of winning market share from their closing competitors. Ultimately, Pfizer will benefit from the recommendations made in this report.
21
Snyder, p. 4 (Refers to the same work by Snyder cited in full in an earlier note.)
Bibliography
*The American Society of Health-System Pharmacists, Sertraline, PubMed, April 13, 2012, http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001017/, accessed on October 29, 2012. *The American Society of Health-System Pharmacists, Sildenifil, PubMed, September 15, 2012, http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001046/, accessed on October 29, 2012. *CDC, The Amount of Prescription Drugs in the United States Varies, CDC.gov, December 19, 2011, Google Scholar, accessed on November 11, 2012. *CDC, Heart Disease Death Rates 2000-2006 Adults Age 35+ By County, CDC.gov, September 18, 2012, Google Scholar, accessed on November 11, 2012. Hoffman, Daniel, As Obama-care Dawns, Big Pharma Rides into the Sunset, Philly.com, September 20, 2012, http://www.philly.com/philly/blogs/healthcare/As-Obamacaredawns-Big-Pharma-rides-into-the-sunset.html, accessed on October 29, 2012. Lipitor, Feirce Pharma, October 9,2012,http://www.fiercepharma.com/special-reports/lipitor-1 accessed on October 29, 2012. McBride, Ryan, Mark, Holmer, Top Ten Pharma Layoffs of 2011, Fierce Pharma, January 4, 2012, http://www.fiercepharma.com/special-reports/top-10-pharma-layoffs-2011, accessed on October 29, 2012. Monroe, Anne, Clinical Trials Explained, Acria, 2012, Google Scholar, accessed on November 1, 2012. *Pfizer Inc. Balance Sheet, http://www.mergentonline.com/basicsearch.php, accessed on October 20, 2012. *Pfizer Inc. Income Statement, http://www.mergentonline.com/basicsearch.php, accessed on October 20, 2012.
Pfizer Products, Pfizer.com, 2012, http://www.pfizer.com/products/#A, accessed on October 29, 2012.
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Ratner, Mark, The Largest Fraud Suit for Off-Label Promotion, Nature Biotechnology, Vol. 28, September 2010, Business Source Premiere, EBSCOhost, accessed on October 24, 2012. *Snider, Sophia, Brand Name Pharmaceuticals in the US, IBISWorld Industry Repot, pp. 1-58, 32541a, 7, 2012, IBISWorld, accessed on October 24, 2012. Steinberg, Steinberg, What Will Pfizer Do With Its Newly Acquired $12 Billion? Seeking Alpha, April 24, 2012, http://seekingalpha.com/article/521351-what-will-pfizer-do-with-its-newly-acquired12-billion, accessed on October 29, 2012. Summary Q1-Q2 2012 Payments to HCP in Millions of $, Pfizer.com, 2011, http://www.pfizer.com/responsibility/working_with_hcp/footnote/2012/footnote_2012.jsp, Google Images, accessed on November 1, 2012.
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