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; and hepatitis B antiviral Hepsera. Beyond HIV/AIDS, Gilead also markets cardiovascular drugs Letairis and Ranexa, as well as respiratory and ophthalmic medicines.
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 90% of product sales and primarily consists of HIV medications.
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 some 225 active clinical studies at the end of 2014. In 2013 it advanced its momelotinib product to Phase 3 (Gilead has more than 50 trials in Phase 3).
The company's portfolio of 19 marketed products contains a number of firsts, such as the first complete treatment regimens for HIV and chronic hepatitis C available in a once-daily single pill.
The US market accounts for some 70% of Gilead's annual revenues. The company operates in more than 30 countries worldwide, with a significant presence in Europe (France, the UK, Spain, Italy, Germany, and Switzerland); it also operates in Africa, South America, and the Asia/Pacific region.
Gilead has R&D facilities in Oceanside and Fremont, California; Branford, Connecticut; Alberta; and Seattle. It has manufacturing sites in San Dimas, California; and Cork, Ireland. Commercial operations are located in 20 offices throughout Europe, seven in Asia, one in South America, and another in North America.
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 Viread exclusively through wholesale channels in the US; Letairis and Cayston are distributed through specialty pharmacies. Customers include physicians, hospitals, clinics, and other health care facilities. The company's product distribution processes are handled primarily by wholesalers, including Cardinal Health (14% of revenues), McKesson, (24%), and AmerisourceBergen (25%).
In 2014 Gilead spent $393 million on advertising, up from $216 million in 2013 and $160 million in 2012.
Increased sales of antiviral products have provided healthy revenue increases for Gilead in recent years. Overall revenue more than doubled in 2014 to $24.9 billion (versus $11 billion in 2013, primarily due to a 145% increase in antiviral product sales. The company's Sovaldi and Stribild products have especially shown growth, particularly in the US and Europe, as has sales of the new hepatitis treatment Harvoni (introduced in 2014). US product sales increased to $18.1 billion in 2014, as compared to $6.6 billion in 2013, thanks to the successes of Sovaldi, Harvoni, Stribild, and Complera.In Europe, product sales rose 54% to $5.1 billion, driven primarily by sales of Sovaldi, Stribild, and Eviplera.
Other new products that have driven up earnings include Letairis, Ranexa, AmBiosome, and Zydelig.
Net income nearly tripled in 2014, rising to $12 billion primarily as a result of growth in revenue. Cash flow from operations also spiked, rising 312% to $12.8 billion (largely due to higher profits and cash generated from accrued liabilities).
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. Harvoni was approved in Europe in 2014.
The company is focused on expanding access to Sovaldi and Harvoni in the US, as well as launching Harvoni in additional markets in Europe and elsewhere. In 2014, 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.
Other new partnerships entered into in 2014 are the license agreement with Ono Pharmaceutical to develop and commercialize GS-4059, a BTK inhibitor for the treatment of B-cell malignancies; and an agreement with Janssen R&D Ireland for the development of a new HIV treatment containing compounds from both companies.
Mergers and Acquisitions
As yet another way of fending off losses from patent expirations, Gilead Sciences has diversified its product line through acquisitions.
In early 2013 Gilead purchased YM BioSciences for some $510 million. The purchase added clinical development programs for oncology therapies in the field of hematologic cancers.
The company entered into an agreement with Phenex Pharmaceuticals in 2015; under the deal, Gilead will acquire Phenex's FXR program for the treatment of liver diseases. That transaction will accelerate Gilead's efforts to develop new treatments for fibrotic liver diseases.
Also in 2015, Gilead acquired EpiTherapeutics, a developer of novel cancer drugs based on epigenetics, for $65 million.