Eli Lilly and Company
NYSE:LLY
$ 302.50
+ $1.18 (0.39%)
$ 302.50
+ $1.18 (0.39%)
End-of-day quote: 08/08/2022

Eli Lilly and Stock

About Eli Lilly and

Eli Lilly and Company discovers, develops, manufactures, and markets products in human pharmaceutical products.

The company manufactures and distributes its products through facilities in the United States (U.S.), including Puerto Rico, and 7 other countries. The company’s products are sold in approximately 120 countries.

Products

The company’s products are as follows:

Diabetes products, such as:

Basaglar, in collaboration with Boehringer Ingelheim, a long-acting human insulin analog for the treatment of diabetes. Eli Lilly and share price history

Humalog, Humalog Mix 75/25, Humalog U-100, Humalog U-200, Humalog Mix 50/50, insulin lispro, insulin lispro protamine, and insulin lispro mix 75/25, human insulin analogs for the treatment of diabetes.

Humulin, Humulin 70/30, Humulin N, Humulin R, and Humulin U-500, human insulins of recombinant DNA origin for the treatment of diabetes.

Jardiance, in collaboration with Boehringer Ingelheim, for the treatment of type 2 diabetes; to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and established cardiovascular disease; and to reduce the risk of cardiovascular death and hospitalizations for heart failure in adults with heart failure and reduced ejection fraction.

Trajenta, in collaboration with Boehringer Ingelheim, for the treatment of type 2 diabetes.

Trulicity, for the treatment of type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adult patients with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.

Oncology products, such as:

Alimta, for the first-line treatment, in combination with two other agents, of advanced non-small cell lung cancer (NSCLC) for patients with non-squamous cell histology and no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations; for the first-line treatment, in combination with another agent, of advanced non-squamous NSCLC; for the second-line treatment of advanced non-squamous NSCLC; as monotherapy for the maintenance treatment of advanced non-squamous NSCLC in patients whose disease has not progressed immediately following chemotherapy treatment; and in combination with another agent for the treatment of malignant pleural mesothelioma.

Cyramza, for use as monotherapy or in combination with another agent as a second-line treatment of advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma; in combination with another agent as a second-line treatment of metastatic NSCLC; in combination with another agent as a second-line treatment of metastatic colorectal cancer; as a monotherapy as a second-line treatment of hepatocellular carcinoma; and in combination with another agent as a first-line treatment of adult patients with metastatic NSCLC with activating epidermal growth factor receptor mutations.

Erbitux, indicated both as monotherapy and in combination with another agent for the treatment of certain types of colorectal cancers; and as monotherapy, in combination with chemotherapy, or in combination with radiation therapy for the treatment of certain types of head and neck cancers.

Retevmo, for the treatment of metastatic NSCLC in adult patients; for the treatment of advanced metastatic medullary thyroid cancer who require systemic therapy in adult and pediatric patients; and for the treatment of advanced metastatic thyroid cancer in adult and pediatric patients who require systemic therapy and are radioactive iodin-refractory.

Tyvyt, in collaboration with Innovent Biologics, Inc., for the treatment of relapsed or refractory classic Hodgkin's lymphoma and for the first-line treatment of non-squamous NSCLC in combination with Alimta and another agent in China.

Verzenio, for use as monotherapy or in combination with endocrine therapy for the treatment of HR+, HER2- metastatic breast cancer and in combination with endocrine therapy for the treatment of HR+, HER2-, node positive, early breast cancer at high risk of recurrence and a Ki-67 score at least 20%, as determined by a U.S. Food and Drug Administration (FDA) approved test.

Immunology products, such as:

Olumiant, in collaboration with Incyte Corporation, for the treatment of adults with moderately-to-severely active rheumatoid arthritis and for moderate to severe atopic dermatitis.

Baricitinib was granted Emergency Use Authorization (EUA) in 2021 for the treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Taltz, for the treatment of adults and pediatric patients aged 6 years or older with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis, adults with ankylosing spondylitis, and adults with active non-radiographic axial spondyloarthritis.

Neuroscience products, such as:

Cymbalta, for the treatment of major depressive disorder, diabetic peripheral neuropathic pain, generalized anxiety disorder, fibromyalgia, and chronic musculoskeletal pain due to chronic low back pain or chronic pain due to osteoarthritis.

Emgality, for migraine prevention and the treatment of episodic cluster headache in adults.

Zyprexa, for the treatment of schizophrenia, acute mixed or manic episodes associated with bipolar I disorder, and bipolar maintenance.

Other therapies, such as:

Bamlanivimab and etesevimab, administered together, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients from birth to 12 years old with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death (EUA granted in 2021). In January 2022, the FDA revised the EUA for bamlanivimab and etesevimab administered together to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to this combination treatment.

Bebtelovimab, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older and weighing at least 40 kilograms) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate (EUA granted in 2022).

Cialis, for the treatment of erectile dysfunction and benign prostatic hyperplasia.

Forteo, for the treatment of osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and postmenopausal women.

Marketing and Distribution

The company sells most of its products worldwide. The company adapts its marketing methods and product emphasis in various countries to meet local customer needs and comply with local regulations.

The U.S.

The company promotes its major products in the U.S. through sales representatives who engage with physicians and other health care professionals. The company also educates healthcare providers about its products in various other ways, including promoting in online health care channels, distributing literature and samples of certain products to physicians, and exhibiting at medical meetings. In addition, the company advertises certain products directly to consumers in the U.S.; and maintains websites and other media channels with information about its major products. The company supplements its employee sales force with contract sales organizations to leverage its resources and reach additional patients in need.

The company maintains special business groups to service wholesalers, pharmacy benefit managers, managed care organizations, group purchasing organizations, government and long-term care institutions, hospitals, and certain retail pharmacies. The company enters into arrangements with these organizations providing for discounts or rebates on its products.

In the U.S., most of the company’s products are distributed through wholesalers that serve pharmacies, physicians and other health care professionals, and hospitals. In 2021, three wholesale distributors in the U.S.—McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc.—each accounted for between 15 percent of its consolidated revenue.

Outside the U.S.

Outside the U.S., the company promotes its products to healthcare providers primarily through sales representatives and other health care channels. While the products the company markets vary from country to country, diabetes products constitute the largest single group of its consolidated revenue. Distribution patterns for the company’s products also vary from country to country. In most countries in which the company operates, it maintains its own sales organizations, but in some smaller countries it markets its products through third-party distributors, some of which it has engaged through distribution and promotion arrangements.

Marketing Collaborations

Certain of the company’s products are marketed in arrangements with other pharmaceutical companies. The company and Boehringer Ingelheim have a global agreement to develop and commercialize a portfolio of diabetes products, including Trajenta, Jentadueto, Jardiance, Glyxambi, Synjardy, Trijardy XR, and Basaglar.

Intellectual Property Portfolio

The most relevant the U.S. patent protection or data protection and associated expiry dates for the company’s major or launched patent-protected marketed products are as follows:

Alimta is protected by pediatric exclusivity (2022).

Baqsimi is protected by data protection (2022).

Cyramza is protected by a compound patent and biologics data protection (2026).

Emgality is protected by a compound patent (2033) and biologics data protection (2030).

Jardiance, and the related combination product Glyxambi, is protected by a compound patent (2028).

Olumiant is protected by a compound patent (2032).

Retevmo is protected by a compound patent (2037) and by data protection (2025).

Reyvow is protected by a compound patent (2030).

Taltz is protected by a compound patent (2030) and by biologics data protection (2028).

Trulicity is protected by a compound patent (2027) and by biologics data protection (2026).

Verzenio is protected by a compound patent (2031) and by data protection (2022).

Outside the U.S., important patent protection or data protection includes:

Baqsimi is protected by data protection in Japan (2026).

Cyramza is protected by a compound patent (2028) and by data protection (2024) in major European countries, and by a compound patent (2026) and by data protection (2023) in Japan.

Emgality is protected by a compound patent (2033) and by data protection (2028) in major European countries, and by a compound patent (2035) and by data protection (2029) in Japan.

Jardiance is protected by a compound patent in major European countries (2029) and Japan (2030).

Olumiant is protected by a compound patent (2032) and by data protection (2027) in major European countries, and by a compound patent (2033) and by data protection (2025) in Japan.

Retevmo is protected by a compound patent (2037) and by data protection (2031) in major European countries, and by a compound patent (2038) and by data protection (2029) in Japan.

Reyvow is protected by a compound patent (2026) and by data protection (2032) in Japan.

Taltz is protected by a compound patent (2031) and data protection (2027) in major European countries and a compound patent (2030) and data protection (2024) in Japan.

Trulicity is protected by a compound patent (2029) and by data protection (2024) in major European countries and by a compound patent (2029) and by data protection (2023) in Japan.

Verzenio is protected by a compound patent (2033) and data protection (2028) in major European countries and by a compound patent (2034) and data protection (2026) in Japan.

The following product candidates are under regulatory review. Upon approval, the company expects relevant compound patent and data protections to apply:

The company has commenced a rolling submission in the U.S. for donanemab for the treatment of Alzheimer's disease.

The company has commenced a rolling submission in the U.S. for pirtobrutinib (LOXO-305) for the treatment of mantle cell lymphoma.

Reyvow has been submitted for regulatory review in certain major European countries for the acute treatment of migraine.

Tirzepatide has been submitted for regulatory review in the U.S., in Japan, and in certain major European countries as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Worldwide, the company sells all of its major products under trademarks consisting of its product names, logos, and unique product appearances (e.g., the appearance of its Trulicity autoinjector), which it considers in the aggregate to be important to its operations. Trademark protection varies throughout the world, with protection continuing in some countries as long as the mark is used, and in other countries as long as it is registered.

Research and Development

For the year ended December 31, 2021, the company’s research and development expenses included $7.03 billion.

Government Regulations

Evolving regulatory priorities have intensified governmental scrutiny of the company’s operations, including with respect to current Good Manufacturing Practices (cGMP), quality assurance, and similar regulations.

Of particular importance to the company’s business is regulation by the U.S. Food and Drug Administration (FDA) in the U.S. Pursuant to laws and regulations that include the Federal Food, Drug, and Cosmetic Act, the FDA has jurisdiction over all of its products and devices in the U.S. and administers requirements covering the testing, safety, effectiveness, manufacturing, quality control, distribution, labeling, marketing, promotion, advertising, dissemination of information, and post-marketing surveillance of those products.

Outside the U.S., the company’s products and operations are subject to similar regulatory requirements, notably by the European Medicines Agency (EMA) in Europe; the Ministry of Health, Labor and Welfare in Japan; and the National Medical Products Administration in China.

In addition to the U.S. application and enforcement of the U.S. Foreign Corrupt Practices Act of 1977 (FCPA), the various jurisdictions in which the company operates and supplies its products have laws and regulations aimed at preventing and penalizing corrupt and anticompetitive behavior.

In the U.S., the company is required to provide rebates to the federal government and respective state governments on their purchases of its pharmaceuticals under various federal and state healthcare programs, including state Medicaid and Medicaid Managed Care programs (minimum of 23.1 percent plus adjustments for price increases over time) and discounts to private entities who treat patients in certain types of health care facilities intended to serve low-income and uninsured patients (known as 340B facilities).

History

Eli Lilly and Company was founded in 1876 by Colonel Eli Lilly. The company was incorporated in 1901 in Indiana.

Country
Founded:
1876
IPO Date:
01/02/1969
ISIN Number:
I_US5324571083

Contact Details

Address:
Lilly Corporate Center, Indianapolis, Indiana, 46285, United States
Phone Number
317 276 2000

Key Executives

CEO:
Ricks, David
CFO
Ashkenazi, Anat
COO:
Data Unavailable

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