Gilead Sciences has biotech balms for infectious diseases, including hepatitis, HIV, and infections related to AIDS. The company's HIV franchise includes Truvada, a combination of two of its other drugs, Viread and Emtriva. It co-promotes another HIV treatment, called Atripla, in the US and Europe with Bristol-Myers Squibb (BMS). Other products on the market include AmBisome, used to treat systemic fungal infections such as those that accompany AIDS or kidney disease; Vistide, for AIDS-related eye infections; and hepatitis B antiviral Hepsera. Beyond HIV/AIDS, Gilead also markets cardiovascular drugs Letairis and Ranexa, as well as respiratory and ophthalmic medicines.
The US market accounts for some 60% of Gilead's annual revenues. The company has other significant operations in European countries including France, the UK, Spain, Italy, Germany, and Switzerland, as well as in South America and the Asia/Pacific region.
Gilead primarily focuses on producing treatments for HIV, liver diseases including hepatitis B and hepatitis C, cancer and inflammation, and cardiovascular and respiratory conditions. Although the company is steadily working to expand in medicines in various fields, its main source of revenue continues to be its antiviral franchise, which contributes more than 80% of product sales and primarily consists of HIV medications. New product launches in antiviral fields include the introduction of HIV drugs Complera/Eviplera in 2011 and Stribild in 2012.
Aside from the Atripla partnership with BMS, Gilead has collaborations with other companies including Japan Tobacco, which promotes HIV drugs Truvada, Viread, and Emtriva in Japan, and with GlaxoSmithKline, which markets Hepsera, Viread, and Volbris in select international markets. Additionally, Gilead Sciences receives royalties on influenza treatment Tamiflu, which it developed with Roche, and on Macugen, an ophthalmologic drug developed by Eyetech using Gilead's technology. In addition to distributing AmBisome in Canada and the US, Astellas pays royalties on US sales of Lexiscan, which is used in stress tests for coronary artery disease.
Gilead continues to advance its R&D pipeline; the company had more than 200 active clinical studies at the end of 2013. That year it advanced its momelotinib product to Phase 3 (Gilead has more than 50 trials in Phase 3).
Sales and Marketing
Gilead promotes its antiviral drugs through its own commercial infrastructure in North America, some European and Asian countries, and in Australia and New Zealand; products are promoted through third-party distributors and partnerships in other regions. Gilead sells and distributes products including Atripla, Sovaldi, and Vistide exclusively through wholesale channels in the US. Customers include physicians, hospitals, clinics, and other health care facilities. The company's product distribution processes are handled primarily by wholesalers, including Cardinal Health (17% of revenues), McKesson, (16%), and AmerisourceBergen (13%).
Increased sales of antiviral products have provided healthy revenue increases for Gilead in recent years, with the antiviral segment accounting for most of Gilead's 15% sales increase to some $11.2 billion in 2013. Sales of Complera, Eviplera, and Stribild have especially shown growth, particularly in the US and Europe. In 2013, increases in Atripla sales were largely driven by an increase in net sales price. Newly launched hepatitis C drug Sovaldi also added revenues that year. Additionally, royalty earnings grew 32% due to an increase in Tamiflu usage.
After a brief period of declining profits, the company reported 19% growth in 2013 as a result of higher revenues and lowered expenses; Gilead had lost $40 million on Greek bonds during 2012.
Cash flow from operations has declined over the past couple of years, though. In 2013 cash flow decreased 3% to $3.1 billion as a result of a decline in accrued liabilities; cash was also used towards income taxes, prepaid expenses, and other charges.
One of the pitfalls of the pharma manufacturing business is patent expirations, where older medications see a decline in sales as they begin to face generic competition. Other medications struggle to penetrate highly saturated markets. To offset potential losses from these challenges, Gilead is working to increase sales of top selling products in new territories. With partner BMS, the firm is especially focused on increasing international commercialization of Atripla. In addition, Gilead works to get existing medications approved for new medical indications.
The company also works to launch new or next-generation drugs to freshen its lineup of patent-protected offerings. The company's development programs include potential treatments for viral infections, liver disease, respiratory and cardiovascular ailments, and various cancers. Gilead also conducts R&D efforts through collaborations; for instance, it has a development partnership with Japan Tobacco on new HIV drugs.
Gilead continues to build up its existing portfolio through internal discovery and clinical development, as well as by acquiring or in-licensing products.
In 2013, the company received FDA approval of hepatitis C drug Sovaldi; it also expanded its HIV product offerings with the launch of once-a-day tablet Stribild. The EMA also approved Vitekta for the treatment of HIV-1 infection. The following year, the European Commission gave marketing approval for Zydelig (idelalisib), a treatment for incurable blood cancers chronic lymphocytic (CLL) leukemia and follicular lymphoma. Sovaldi was also given the go-ahead in Europe;
The FDA granted approvals for Harvoni, Tybost, and Zydelig, for the treatment of hepatitis, HIV, and cancer, respectively, in 2014. Also that year, Gilead signed licensing agreements with nine India-based generic pharmaceutical manufacturers to increase access to its chronic hepatitis C medications (including Sovaldi) in more than 90 developing nations.
Mergers and Acquisitions
As yet another way of fending off losses from patent expirations, Gilead Sciences has diversified its product line through acquisitions.
The company made a bold diversification move in early 2012 when it purchased Pharmasset, a development firm with a promising pipeline of hepatitis C candidates, for some $11 billion. Following the purchase, Pharmasset's operations were integrated into the Gilead organization.
In early 2013 Gilead completed another deal, this time purchasing YM BioSciences for some $510 million. The purchase added clinical development programs for oncology therapies in the field of hematologic cancers.