GlaxoSmithKline (GSK) gives anxiety, asthma, and other ailments the ax. One of the top five pharmaceutical firms in the world, GSK's bestsellers include respiratory, neurological, cardiovascular, and dermatology drugs, as well as vaccines and antivirals. Its top product is asthma medication Advair (aka Seretide), which combines two of its other asthma products, Flovent and Serevent. Other bestsellers include epilepsy treatment Lamictal, cholesterol medicine Lovaza, prostate enlargement drug Avodart, and antibiotic Augmentin, as well as Cervarix and Pediarix vaccines. The company's consumer products include Tums, dental care products Aquafresh and Sensodyne, and smoking-cessation products NicoDerm and Nicorette.
The company markets its products directly to hospitals, pharmacies, doctors, and other health care consumers; it also uses wholesale distributors in some markets and serves customers in more than 100 countries overall. Pharmaceuticals account for two-thirds of sales, with vaccines and consumer health products making up the remainder of revenues. Respiratory drugs are the company's largest sales category, primarily due to blockbuster Advair, which brings in more than £5 billion ($6.7 billion) annually. GSK also has a strong presence in the central nervous system, cardiovascular, urogenital, dermatology (through its Stiefel division), virology, infectious disease, oncology, and metabolism treatment markets.
As sales in GSK's largest market, the US, account for more than a third of pharmaceutical sales, maintaining a rich portfolio of US patent-protected products can make or break the company's future. Examples of GSK drugs that have experienced sales slumps due to patent losses include its bestselling herpes drug Valtrex, which began facing generic competition in 2009 and accounted for a 5% to 10% drop in US and European pharmaceutical sales in both 2010 and 2011. Other recent patent losses include cardiovascular drug Arixtra and oncology drug Hycamtin, both of which began facing generic competition in 2011.
The development of new potential blockbusters is the best way to alleviate these losses, and GSK's development efforts include about 100 different clinical stage projects. Its major R&D centers are located in the UK, the US, Spain, Belgium, and China. GSK has some 30 candidates in late-phase trials for conditions such as HIV, pulmonary conditions, Parkinson's disease, type-2 diabetes, heart disease, and various cancers. One candidate, Benlysta, became the first lupus therapy approved by the FDA in more than 50 years in 2011; the drug was developed with Human Genome Sciences(HGS) and was also approved in Europe that year. Other drugs launched in 2011 include epilepsy treatment Potiga (also known as Trobalt) and restless leg syndrome medication Horizant.
GSK is also working to pump potential new blockbusters into its pipeline by acquiring promising research firms and forming development agreements with other drug companies. For instance, the company is developing cancer drug Arzerra for additional indications with biotech firm Genmab. It also has development deals with OncoMed (for new cancer treatments) and Theravance (respiratory drugs). GSK is also working with Pfizer on HIV medications; many of the company's HIV and vaccine development programs aim to provide affordable disease preventions and treatments to developing countries.
To further solidify its R&D relationships, in 2012 the company increased its minority stake in development partner Theravance from 19% to 27%, acquired a 15% stake in companion diagnostic test provider and partner Response Genetics Inc. (RGI), and fully acquired HGS for some $3 billion. In acquiring HGS, GSK gained full access to Benlysta and other partnered development candidates.
A major trend among pharmaceutical companies is to focus on growing in emerging markets, which represent an opportunity for big sales because of a relatively untapped consumer base. Towards that end, GSK owns a minority stake (about 20%) in South African generic drugmaker Aspen Pharmacare; it has also established a presence in select Asian, African, Latin American, and Middle Eastern nations. In 2010, the company spent about £174 million ($250 million) to expand in Latin America with the buy of Laboratorios Phoenix, an Argentinean drug manufacturer and marketer.
GSK also expanded its Asian operations by acquiring Nanjing MeiRui Pharma, a Chinese manufacturer of allergy and urology products, in 2010 and by buying out its Chinese partner, Neptunus, in a joint venture to manufacture influenza vaccines in 2011. The following year GSK formed a joint venture with Daiichi Sankyo to make and sell vaccines in Japan, a market where GSK has seen rapid growth in recent years.
CEO Andrew Witty is intent on keeping the company focused on small strategic acquisitions and expansion in fast-growing markets, including vaccines, biopharmaceuticals, and consumer health products. He is also carrying forth the company's ongoing cost-cutting measures, which aim to reduce operational expenses through measures such as simplifying its administrative infrastructure, narrowing its R&D programs, and consolidating its drug development and manufacturing sites. To focus on its top selling drugs and R&D investments, the company is also divesting assets where it sees fit.
For instance, GSK sold a penicillin manufacturing site in Bristol, Tennessee, to Dr. Reddy's Laboratories for an undisclosed price in 2011. The sale also included the rights to the Augmentin and Amoxil brands in the US. GSK kept the rights to those brands outside the US. The firm also sold its minority stake (about 20%) in laboratory services firm Quest Diagnostics (which provides clinical trial testing to GSK) for some £585 million ($1.1 billion), and it sold North American rights back to Valeant Pharmaceuticals for antiviral cream Zovirax.
Still in the mood to divest, GSK also announced plans to sell some noncore consumer health brands. In early 2012 it completed the sale of a portfolio of North American OTC brands, including BC, Beano, Ecotrin, Fiber Choice, Goody's, and Tagamet, to Prestige Brands Holdings for some £426 million ($660 million). Later in 2012 GSK reached agreements to sell its noncore OTC offerings in Europe and other international markets, including Solpadeine and Zantac; European rights will go to Omega Pharma for some £391 million ($614 million) and rights in other international markets will be sold to Aspen Pharmacare for some £164 million ($263 million). GSK also plans to divest global rights to its OTC weight loss product, alli.
The company has faced some trouble in recent years over diabetes drug Avandia, which was linked to heart attack risks in 2007. GSK has since withdrawn sales of the drug in most markets; the European Medicines Agency suspended marketing authorization for Avandia in 2010, and the FDA placed use of the drug under a strict risk evaluation and mitigation strategy (REMS) program that same year. In addition, the firm is working to settle a large number of patient lawsuits related to Avandia.
GSK paid $3 billion in 2012 to settle numerous fraud charges by the US Justice Department and other federal and state autorities, including for failing to report safety data on Avandia. The agreement, which was the largest such drugmaker settlement to date, also covered lawsuits over improper sales and marketing practices for several other products, as well as improper Medicaid reimbursement activities.
Overall revenues declined 1% in 2011 to £27.4 billion ($43.4 billion) as GSK worked to stabilize its operations following the Valtrex patent loss. (Sales had decreased 3% the previous year largely due to the increase in generic competition.) Other factors impacting the firm's revenues in 2010 and 2011 include decreased sales of Avandia and a drop in demand for pandemic flu vaccines and flu-related antivirals. Net income also fell in 2010 to some £1.6 billion ($2.5 billion) due to legal expenses, but in 2011 profits bounced back to previous levels of more than £5 billion ($8 billion). Sales from new product launches, as well as increased revenues in emerging and Asian markets, have helped to offset the impact of competition and other factors causing flat or decreased sales in the US and Europe.