Best known for its neuroscience products, pharmaceutical company Eli Lilly also makes endocrinology, oncology, and cardiovascular care medicines. Its top-selling drugs include Cymbalta for depression and pain, Alimta for lung cancer, Humalog and Humulin insulin for diabetes, and Cialis for erectile dysfunction. Lilly also makes medications to treat schizophrenia and bipolar disorder (Zyprexa), osteoporosis (Evista and Forteo), heart conditions (Effient), ADHD (Strattera), gastric and lung cancer (Cyramza), and diabetes (Jardiance and Trulicity), as well as anti-infective agents and a growing line of animal health products.
Lilly has been around for more than 130 years and, unlike many other drug companies, has kept its operations focused almost exclusively on the task of pharmaceutical manufacturing. The company operates in two business segments: human pharmaceutical products and animal health. Pharmaceuticals for human consumption account for about 85% of annual revenues, while medicines for livestock and companion animals (including Rumensin, Posilac, Tylan, and Optaflexx, produced through its Elanco animal health unit) make up the rest of sales. The company has sailed steadily through a number of ups and downs without making drastic changes to its business model or its growth strategy of conducting focused R&D, forming joint ventures and collaborations, and making selective acquisitions. For example, the company co-promotes Cymbalta in Japan with Shionogi & Co.; Erbitux is marketed in the US and Canada by Lilly and elsewhere by Merck. Additionally, the company has a diabetes collaboration with Boehringer Ingelheim through which they jointly develop and commercialize Trajenta, Jentadueto, Glyxambi, Synjardy, and Basalgar.
The company's steady operational performance places it on firm ground even as Lilly enters a challenging time of significant patent expirations. For example, its Cymbalta and Evista offerings lost US protection in December 2013 and March 2014, respectively. Its pipeline is progressing, though, with new drug approvals and launches helping to offset the impact of generic competition on sales of aging products. In 2015 the company launched Jardiance and Trulicity for type 2 diabetes and Basalgar for type 1 and type 2 diabetes.
Lilly sells its products in some 125 countries, with the US market accounting for about half of the company's sales. Europe accounts for about 20% of sales while Japan accounts for about 10%.
The company operates research, manufacturing, and distribution facilities in the US and 15 other countries in Europe, Asia, Australia, and the Americas. It owns 13 production and distribution sites in the US and Puerto Rico; major production sites are located in Indianapolis and Clinton, Indiana; Branchburg, New Jersey; and Carolina, Puerto Rico. Lilly's major international production sites are located in Ireland, the UK, France, Italy, Spain, and China.
Altogether, Lilly conducts R&D in six countries, clinical trials in about 50 countries, and has manufacturing facilities in more than a dozen countries.
Sales and Marketing
In the US, Lilly's products are promoted to physicians, hospitals, veterinarians, and pharmacies through direct sales representatives and contract sales organizations. Products are distributed through independent wholesalers, primarily AmerisourceBergen, Cardinal Health, and McKesson. These three distributors each account for between 8% and 19% of annual sales. Internationally, the company uses a direct sales force in most markets, though it occasionally markets products through independent distributors.
Lilly also advertises in medical journals and markets its products at medical conferences.
After years of steady revenue growth, patent expirations and a lack of new blockbusters have taken their toll. Lilly has seen fluctuation revenue in the last five years, with peaks in fiscal 2011 and 2013 and dips in 2012 and 2014. In 2015, revenue rose 2% to $19.9 billion thanks to sales of new drugs (Cyramza and Trulicity) and contributions from the newly acquired Novartis Animal Health. The Elanco animal health business also boosted earnings, but these gains were partially offset by revenue declines from Cymbalta, Evista, and Alimta as a result of foreign currency exchange rates.
After net income fell 49% in 2014 (due to lower revenue that year as well as restructuring expenses), it rose less than 1% to $2.4 billion in 2015. That modest gain was driven by the 2% revenue increase and a decrease in income taxes.
Cash flow from operations has been falling and, in 2015, it dropped a further 37% to $2.8 billion due to increases in receivables and inventories.
The company has sailed steadily through a number of ups and downs without making drastic changes to its business model or its growth strategy of conducting focused R&D (it spends about $5 billion per year on research), forming joint ventures and collaborations, and making selective acquisitions. It has some 50 drug candidates in clinical development stages, as well as additional preclinical candidates. Its R&D programs focus on five therapeutic categories -- neurology, endocrinology, oncology, autoimmune diseases, and cardiovascular diseases -- and include potential treatments for cancer, diabetes, rheumatoid arthritis, depression, vascular disease, and Alzheimer's disease.
In 2014, Lilly launched three new medicines: Cyramza (for advanced gastric and metastatic lung cancer), Jardiance, and Trulicity (both for type 2 diabetes). That year the FDA approved Cyramza to be used with paclitaxel, a type of chemotherapy.
The company is also pursuing additional indications for existing drugs. Biotechnology has become an increasingly important area of R&D, with about half of the drugs in Lilly's pipeline coming from biotech molecules (derived from proteins). Its programs are conducted both independently and through collaborations and licensing agreements.
In 2014, the company entered into a global agreement with AstraZeneca to co-develop and co-commercialize AstraZeneca's AZD3293, which is being investigated for the potential treatment of Alzheimer's disease. In a similar agreement, it will develop and commercialize Adocia's BioChaperone Lispro, an ultra-rapid insulin compound designed to treat patients with type 1 and type 2 diabetes.
In 2015, Lilly gained global rights to Locemia Solutions' clinical-stage intranasal glucagon, which is being tested for severe hypoglycemia in people with diabetes. The following year, the company entered a collaboration agreement with Boehringer Ingelheim to study the combination of Lilly's cyclin-dependent CDK 4/6 inhibitors and Boehringer's IGF 1/2 antibody for patients with breast cancer.
To help offset any declines in its human pharmaceutical products segment, Lilly has also been expanding its animal health segment, primarily through acquisitions. After acquiring Novartis Animal Health in early 2015, Lilly became the second-largest animal health company in the world. It plans to continue investing in the segment to maintain its leading position in the market.
The company is expanding its global R&D headquarters in Indianapolis. It is adding 130,000 sq. ft. to the facility; the space will include a multi-disciplinary laboratory to promote research across multiple research functions.
Mergers and Acquisitions
Acquisitions are another key way in which Lilly boosts its development pipeline. In 2014 Lilly acquired the development rights for a calcitonin gene-related peptide antibody that is being studied as a possible treatment for frequent migraine headaches.
Lilly has also been expanding its animal health division, primarily through acquisitions, to help offset potential future losses in the core pharmaceuticals segment. In 2014 its Elanco Animal Health unit acquired Germany's Lohmann Animal Health, a producer of poultry vaccines and feed additives. Lohmann also brought on board vaccine production facilities in the US and Germany as well as nearly 20 subsidiaries in Europe, Asia, and North America. Shortly thereafter, Lilly picked up Novartis Animal Health and its nine manufacturing plants, six R&D facilities, 600 products, and global distribution infrastructure for $5.4 billion. The move created the second-largest animal health company in the world. Now Elanco plans to buy the US feline, canine, and rabies vaccine portfolio of Boehringer Inghelheim's Vetmedica unit for $885 million.