AstraZeneca is one of the world's largest pharmaceutical companies, with FY2009 sales of $32.8 billion and $7.5 billion in profits. AstraZeneca's wide-ranging portfolio of products includes some of the world's most successful drugs. Among other blockbusters, AstraZeneca produces cholesterol fighter Crestor and the ubiquitous "purple pill" Nexium, one of the best-selling drugs in history.
Analysts credit AstraZeneca with having one of the most diversified drug portfolios in the pharmaceutical industry. AstraZeneca's blockbuster drug Nexium is the industry leader in treating gastrointestinal disorders like heartburn. The company also has a significant presence in cardiovascular therapy with Crestor, neurology with Seroquel, and respiratory treatments with Pulmicort and Symbicort. In all, AstraZeneca has 9 blockbuster drugs (with $1 billion or more in annual sales) in five different therapeutic categories. The strong performance of these drugs has propelled earnings growth in recent years.
Despite sunny short term prospects, AstraZeneca will face serious challenges in the future. Despite substantial R&D spending, the company's development pipeline has failed to produce any extremely promising candidates for future blockbuster drugs. In response to the coming drug drought, AstraZeneca recently acquired MedImmune for $15.6B. Although the acquisition may help to revive AstraZeneca's lackluster pipeline, many investors caution that AstraZeneca paid far too high a price for the company.
Based in London, AstraZeneca was formed in 1999 when Astra AB of Sweden merged with Zeneca Group PLC of the UK. The merger produced one of the world's largest pharmaceutical companies, employing 66,000 people in over 100 countries worldwide. In fiscal year 2008, AstraZeneca reported almost $31.6 billion in sales and $6.1 billion in net profit. AstraZeneca's impressive portfolio of drugs includes some of the world's most successful blockbusters. In addition to the ubiquitous "purple pill" heartburn drug Nexium and cholesterol fighter Crestor, AstraZeneca had 9 blockbuster drugs in 2009. All in all, these products generated 76% of the company's revenue in 2009.
Gastrointestinal - Prilosec and Nexium AstraZeneca is the market leader in treating gastrointestinal disorders like heartburn and acid reflux. In this therapeutic area, AstraZeneca has produced two of its most successful blockbusters: Prilosec and Nexium. Prilosec was the first in AstraZeneca's line of proton pump inhibitors, which treat acid reflux. Prilosec lost patent protection in 2002 but has remained resilient among strong generic competition, bringing in $946 million in 2009. In response to Prilosec's loss of patent protection, AstraZeneca enhanced and re-branded the drug under the name Nexium. A strong marketing campaign and additional therapeutic benefits has produced strong results for "the new purple pill." Nexium raked in $4.96 billion in 2009 and is AstraZeneca's top-selling product, although sales have decreased 1% from 2008.
Cardiovascular - Crestor, Seloken/Toprol-XL & Atacand Cardiovascular disease is the leading cause of death in the world, accounting for over 30% of all human deaths every year. Hypertension, or high blood pressure, is the most common of all cardiovascular diseases, affecting 25% of the world's population; additionally, hypertension is often a precursor of more severe cardiovascular conditions. AstraZeneca has a strong presence in cardiovascular-related pharmaceuticals. Crestor, AstraZeneca's most successful CV drug with $4.5 billion in 2009 sales, treats high cholesterol. In December of 2009, an FDA panel backed an expansion of Crestor's label to treat patients with "healthy" cholesterol levels who are otherwise at risk for heart disease. This expansion could open the market for Crestor significantly -- the FDA estimates by an additional 6.5 million patients - and 2012 projections for the drug now reach $6.75 billion. AstraZeneca also has two blockbusters targeted at hypertension: Seloken/Toprol-XL recorded sales of $1.44 billion in 2009, and Atacand, a first-line treatment of hypertension also had sales of $1.44 billion. 
Neuroscience - Seroquel AstraZeneca's most successful drug for the treatment of neurological disorders is Seroquel. Seroquel competes in the antipsychotic drug market, and can be used to treat several mental imbalances. Seroquel is used to treat schizophrenia in 87 markets globally and bipolar mania in 73 markets. However, the drug may significantly increase the risk of diabetes. AstraZeneca is currently facing some 9,000 lawsuits involving 15,000 patients alleging that the company knowingly downplayed weight gain and diabetes risks. In mid 2008, AstraZeneca won a U.S. patent battle against generics manufacturers, securing its exclusivity to Seroquel until at least 2011. Sales of the drug were $4.87 billion in 2009.  On August 9th, 2010 the company announced to pay $198 million to settle over settle a little over half of the U.S. lawsuits (roughly 17,500) that allege Seroquel caused diabetes and other harm.The company has already disposed of 4,725 Seroquel cases. During the announcement the company confirmed that these and future payouts will not affect its 2010 profit forecast.
Cancer - Arimidex, Casodex & Zoladex AstraZeneca is also a big player in cancer-related pahrmaceuticals. Cancer is now the second-leading cause of death in the US and Europe after cardiovascular disease. Over 10 million people are diagnosed with cancer every year. AstraZeneca has a strong portfolio of three blockbuster oncology drugs. Arimidex, which had sales growth of 7% last year and $1.92 billion in revenues, is one of the world's most successful breast cancer drugs. Casodex, another blockbuster, treats prostate cancer, which is the most common cancer among American men. Casodex had sales of $844 million in 2009, a 34% decrease due to generic competition. AstraZeneca's third blockbuster cancer drug Zoladex is approved for use against both breast and prostate cancer and reached $1.09 billion in sales in 2009.
Respiratory - Symbicort & Pulmicort AstraZeneca also has a notable offerings in the treatment of asthma and other respiratory disorders. The company markets two drugs targeted at asthma. The first, Symbicort, achieved 23% growth for sales of $2.29 billion in 2009. The second, Pulmicort, had sales of $1.31 billion in 2009, a 10% decrease from 2008 as generic competition entered the market. Symbicort was linked by the FDA to an increase in serious long-term asthma-related side effects. Similar drugs of the same class from other major drug manufacturers were also implicated, making any regulatory action likely unilateral. 
In Q2 of 2010, AstraZeneca reported sales of $8.18 billion, an increase of 2.8% from Q2 of 2009. The company reported net income for the quarter of $2.1 billion, a 22% growth. The increased sales were largely driven by strong sales in emerging markets that outweighed declining revenue in the United Sates. The company's key brands of Crestor, Seroquel and Symbicort performed well. Crestor's sales increased by 23% to $1.43 billion, Symbicort saw a 20% gain to $664 million while Seroquel's revenue reached $1.35 billion, a 8% increase. While the company raised its 2010 guidance from between $6.05 and $6.35 per share to between $6.35 and $6.65 per share, it cautioned that generic competition could curt second-half earnings.
In Q1 of 2010, AstraZeneca reported sales of $8.6 billion, an increase of 11% from 2008. The company reported net income for the quarter of $2.9 billion, a 29% growth. The increased sales were largely driven by growth from the company's largest blockbuster, Crestor, which saw a 27% growth after the FDA expanded its indication to treat patients who are at risk but do not yet have clinical evident heart disease. While the company raised its 2010 guidance from between $5.90 and $6.30 per share to between $6.05 and $6.35 per share, it cautioned that patent expiration may temper its growth over the next few years.
AstraZeneca reported strong profits in Q2 FY2009 from a year before, posting $1.72B in revenue compared to $1.63B the year before. Sales were flat at $7.96B, as adverse currency movements wiped out a 9% gain on constant currency levels. Sales of Crestor were again strong, rising 33% to $1.13B. Decreased costs also helped, with AZN making a variety of cuts (distribution, R&D, sales.
In Q3 2009, AstraZeneca reported sales of $8.2 billion, a growth of 10% over the same quarter of 2008 using contant exchange rates (5% using real exchange rates). Revenue was bolstered by increased flu vaccine sales as well as a 14% increase in US sales and a 15% growth in emerging markets. Earnings before tax were $3.61 billion, a 24% increase from the previous year. The numbers beat analyst estimates and AstraZeneca rose its outlook for the year $6.20-6.40 per share from $5.70-6.00.
For Q4 2009, AstraZeneca reported sales of $8.95 billion, a growth of 4% from the same quarter of the previous year. The company reported a net income of $1.55 billion for the quarter. In AstraZeneca's 2010 guidance, the company saw a difficult year for sales, as generic competition for several of its former blockbuster drugs enters the market. The company forecasted 2010 earnings between $5.75 and $6.15 per share, down from $6.32 in 2009. In anticipation of the revenue losses, AstraZeneca announced that it would cut 8,000 jobs (12% of its workforce) and undertake a $2 billion restructuring campaign that it expects to deliver annualized cost savings of $1.8 billion by 2014.
Researching and developing new drugs is the single most important consideration when identifying the prospects of any pharmaceutical company. The process is lengthy and extremely costly. During development phases, researchers and scientists must screen hundreds of thousands of compounds. Out of these hundreds of thousands of compounds only one may be effective for treatment. This process represents the pharmaceutical equivalent of finding a needle in a haystack. The hunt for the next blockbuster drug may take in excess of 10 years and can cost as much as $800 million dollars. A successful drug pipeline is critical for pharmaceutical companies because former blockbusters losing patent protection must be constantly replaced by new viable drugs.
AstraZeneca's core of highly successful drugs represents one of the youngest and most diversified portfolio in the pharmaceutical industry. Despite this, the firm faces many challenges in the mid to long term: AstraZenecas' prospects after the year 2010 are decidedly dim. Despite a 28% increase in research and development spending in 2007 to $5B and another $5B in 2008, AstraZeneca has failed to produce any truly groundbreaking drugs to complement its robust portfolio. This problem is compounded by several pipeline setbacks afflicting the company: three of AstraZeneca's most promising drugs were stopped in phases II and III testing due to health concerns. When a drug enters phase II, it is determined safe enough for experimental usage amoung a few hundred patients. Phase III testing involves calculating the risk/reward ratio of a potential drug. Prime among these was the blood thinner Exanta which was expected to bolster the company's CV therapeutic division.
One promising drug for AstraZeneca is Brilinta, a late-stage development vascular drug. The compound, also known as ticagrelor, has been shown in a study to have lower death rates than competitor Bristol-Myers Squibb Company (BMY)'s Plavix.
On July 28th,2010, US advisory committee for the FDA voted 7-1 to recommend approval of Brilinta for patients suffering from heat attacks or chest pain who need drug therapy or an artery-clearing procedure. This is a victory for AZN to offset expiring patents on some of its best-selling medicines. The company overcame doubts about the drug's effectiveness in US patents as the clinical trial conducted in North America with a relatively small group of 18,000 patients did not see benefit from the drug. Analysts predict Brilinta's sales could top $1 billion a year based on strong results showing the efficacy of the medicine. There is a buzz that the drug might be able to achieve "mega-blockbuster' status of around $4 billion a year revenue as it competes head-to-head against Plavix, Sanofi-Aventis SA (SNY) and Bristol-Myers Squibb Company (BMY)'s anti-clotting drug, the world's second best selling drug with annual sales of about $9 billion. The FDA is supposed to make a final decision on Brilinta by Sept. 16. The agency usually follows panel recommendations.
One effective way for pharmaceutical companies to expand or plug holes in their drug portfolios and pipelines is through major acquisitions. In response to dimming increasingly prospects, AstraZeneca acquired MedImmune in 2007 for $15.6B. The most promising aspect of MedImmune's portfolio is its Synagis franchise which is used to protect pre-mature and other high-risk babies during RSV season. Sentiment over the deal has been mixed. While some believe that the acquisition will provide a bridge over troubled waters, others caution that AstraZeneca may have greatly overpaid to snap up the company. 
When FDA commissioner Margaret Hamburg began her tenure in 2009, she announced that the FDA would toughen it's enforcement efforts to protect public health. As the FDA has drawn criticisms for its failures in preventing deaths caused by drugs such as Vioxx, Hamburg has come in with several fixes that include stricter monitoring of drug adverse events, more funding for the agency, stronger ability to force product recalls, and more scientific expertise within the agency. On May 19, 2010, the FDA announced 21 proposals aimed at increasing transparency to the public regarding regulatory information.
Such information will increase the amount of information accessible to the public with regard to companies' pipeline drugs and manufacturing facilities that might otherwise not have been disclosed. While the tightened regulations and increased transparency will eventually improve the overall quality of pharmaceutical products, there will be growing pains as companies adjust to the stricter standards and stronger enforcement. AstraZeneca's ability to adjust to these new standards will impact its valuation and financial success.
On September 21, 2009, AstraZeneca's MedImmune unit, which manufactures all of its vaccines, announced that the U.S. government had ordered an additional 29 million doses of the H1N1 vaccine. This recent order, brings the grand total of MedImmune H1N1 vaccines on order to 42 million, a cost of about $452 million. The government has currently ordered 251 million doses of H1N1 vaccine from 5 manufacturers. However, with a population of 300 million people and some people requiring more than 1 dose, more orders may be on the way. MedImmune's ability to capture remaining orders of H1N1 vaccine may significantly affect both its bottom line and its brand presence as a vaccine manufacturer. AstraZeneca earned $152 million from its H1N1 nasal spray vaccine in Q3 of 2009.
Emerging markets across the globe present another strong growth opportunity for AstraZeneca. As populations in emerging markets such as BRIC (Brazil, Russia, India and China) grow wealthier, they are gaining access to ever more sophisticated health services. As consumers from Russia to China begin to seek treatment from everything from heartburn to high cholesterol, hundreds of millions of these potential customers will turn to AstraZeneca's pharmaceuticals. The sheer size of these population make the emerging markets an incredible opportunity for growth for pharmaceutical companies like AstraZeneca.
Due to Food and Drug Administration (FDA) regulations, pharmaceutical patents last 17 years in the United States, during which a pharmaceutical company has an exclusive right to manufacture a particular drug. After the patent expires, generic versions of the product can be produced and sold by competitors. Generic medication is cheaper than brand medication, undercutting the pricing power of the original pharmaceutical producer. It is estimated that the loss of patent protection for brand named drugs may reduce sales by up to 90%. Because of the stark decrease in pricing and general revenue generation that occurs with the lost of patent protection, AstraZeneca's business model is highly sensitive to patent protection and the enforcement of intellectual property rights. AstraZeneca has been surprisingly resilient in response to the loss of patent protection in the past. The best example of this came with Prilosec's loss of patent protection in 2002. AstraZeneca responded by rebranding the drug as Nexium, which went on to become the company's best selling drug.
Eight patents on drugs that represent 60 percent of the company's current sales are due to expire in the next eight years. The company also has eight products near the end of its product pipeline and launch. However, it is not clear whether all of these drugs will receive regulatory approval or whether they can replace sales lost to generics.
One of AstraZeneca's largest new products is saxagliptin, a diabetes drug co-developed with Bristol-Myers Squibb. However, even before its launch in 2009, competitor Novartis has developed a drug called Galvus. The two drugs share significantly similarities in chemical structure and pharmaceutical action, so it is unclear how they will fare after launch.
AstraZeneca's Pulmicort was the subject of a patent infringement settlement in late 2008. Israel-based Teva Pharmaceutical Industries had released and been selling a generic version of the drug in the United States, but AstraZeneca threatened with a law suit and successfully forced a settlement. Teva will cease sales of the drug until December 2009, when it will pay AstraZeneca royalties. 
On June 29th 2010, the U.S. District Court in Delaware defended AstraZeneca's patent for Crestor against generic manufacturers. The court ruled that the patent is valid, denying the claims of the defendents that the obviousness of the invention makes its patent invalid. The ruling gives an instant boost to AZN as Crestor is a multi-billion dollar product and does not come off patent protection till 2016. 
AstraZeneca also faces serious political pressures to increase accessibility to drugs in its two major markets: Europe and the United States. In these two markets, politicians have been pushing aggressively for AstraZeneca to lower drug costs or expand generic licensing. In 2006, European governments such as France and Germany took particularly drastic price reduction measures that adversely affected earnings in these markets. In the United States, legislators have also sought price reductions by giving federal programs such as Medicare and Medicaid increased latitude in its negotiations with pharmaceutical companies.
Pharmaceutical companies are seeking to cut manufacturing costs by outsourcing drug production overseas. U.S. drug companies already outsource 33% of the $45 billion in total R&D spending.
AstraZeneca has expressed an intent to outsource all of its manufacturing operations within ten years, becoming a purely research and development company. Most of the job cuts announced so far have been in the manufacturing divisions.
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