Company Analysis - Gilead

Part
01
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Part
01

Company History and Corporate Goals - Gilead

Gilead Sciences was founded in 1987 originally as Oligogen. The company has gone through 17 mergers and acquisitions since it was founded with the latest being the acquisition of Cell Design Labs and Kite Pharmaceuticals Inc. in 2017.

Gilead Sciences History

  • Gilead is a biopharmaceutical company that manufactures and commercializes innovative medicines for critical diseases. The company was founded as Oligogen on June 22, 1987, by Michael Riordan, M.D.

Drug Approvals Timeline

  • The company began the development of small-molecule antiviral therapeutics in 1991.
  • In 1999, the U.S. Food and Drug Administration approved Tamiflu, a product of Gilead Sciences for the treatment of influenza A and B in adults. The FDA also approved AmBisome for the treatment of cryptococcal meningitis in HIV-infected patients in July 2000.
  • In October 2001, the FDA approved Viread for the treatment of HIV infection. In February, the European Medicines Agency approved Viread for the treatment of HIV infection and later the same year, the FDA approved Hepsera for the treatment of chronic hepatitis B.
  • In 2003, the European Medicines Agency and the U.S. Food and Drug Administration approved Emtriva for the treatment of HIV. The same year, the European Medicines Agency also approved Hepsera for the treatment of chronic hepatitis B.
  • The U.S. FDA approved the use of Macugen for age-related macular degeneration, and Truvada was also approved for the for HIV combination therapy in 2004.
  • The European Medicines Agency approved Truvada for the treatment of HIV in 2005.
  • In 2006, Gilead's medicine Truvada was listed among the preferred Nucleoside Reverse Transcriptase for treatment-naive patients. The U.S. FDA later approved Atripla and Ranexa drugs in the same year.
  • Atripla was approved by the European Medicines Agency and Health Canada for the treatment of HIV. The U.S. Food and Drug Administration approved Letairis for the treatment of pulmonary arterial hypertension in 2007.
  • Gilead's Ranexa was approved as a first-line treatment for chronic angina. The U.S. FDA and European Medicines Agency approved Viread for the treatment of chronic hepatitis B in adults. The U.S. FDA also approved the use of Lexiscan for patients unable to undergo adequate exercise stress in 2008.
  • The U.S. FDA approved Cayston for the improvement of respiratory symptoms in cystic fibrosis patients in 2010.
  • In 2011, Complera was approved for the treatment of HIV-1 infection by the U.S. FDA, and the European Medicines Agency also approved Eviplera for the treatment of HIV.
  • The U.S. FDA approved Truvada, Viread, and Stribild in 2012.
  • The European Commission approved Tybost and Vitekta. Sovaldi was approved for the treatment of chronic hepatitis C as a component of a combination antiviral treatment regime by the U.S. FDA in 2013.
  • In 2014, Gilead signed a generic licensing agreement with Indian generic partners helps increase access to Gilead hepatitis C medicines in developing countries. In the same year, the U.S. FDA approved Harvoni, Tybost, Vitekta, and Zydelig.
  • The U.S. FDA approved Genvoya as a once-daily, single-tablet regimen for HIV-1 infection in 2015.
  • By 2016, Gilead's HIV medicines have reached over 10 million people in developing countries. Odefsey, Descovy, Epclusa, Vemlidy were all approved by the U.S. FDA.
  • Gilead launched the COMPASS Initiative to help address HIV/AIDS in the Southern United States. The company pledged $100 million over 10 years to support efforts to reduce HIV-related stigma and inequalities. Yescarta, Vosevi, Sovaldi, and Harvoni medications were all approved by the U.S. FDA in the same year.
  • The most recent approval for Gilead manufactured drug was for Biktarvy for the treatment of adults with HIV-1 infection by the U.S. FDA in 2018.

Mergers and Acquisitions

Corporate Goals

  • Integrity, inclusion, teamwork, accountability, and excellence are the company's core values.
  • Vision statement: "To advance therapeutics against life-threatening diseases worldwide".
  • Mission statement: "To discover, develop and commercialize innovative therapeutics in the areas of unmet medical needs that improve patient care."
  • In its efforts to maintain the sustainability in its businesses, Gilead Sciences in 2018, launched a CSR committee to help ensure their business meets the highest social and environmental standards.
  • Through its research and development efforts, Gilead is focused on advancing the care of patients and fostering their relationships with physicians, patients and their caregivers, and employees.
  • In alignment with Gilead Science’s goal, the company “invest in programs that promote prevention, strengthen healthcare infrastructure, and provide education and social and financial support to the most vulnerable communities around the world” and also enable access to medicines, fight stigma and collaborate with partners worldwide.

Partnerships

  • Gilead entered into 25 partnerships, licensing, merger & acquisition deals to enhance their research pipeline in therapeutic areas which is in line with the company’s goals.
  • Gilead Sciences expanded access to HIV, viral hepatitis and visceral leishmaniasis treatments to low and middle-income countries.
  • Through its collaboration with the WHO, Gilead Sciences is working to eliminate chronic hepatitis C in the world.
  • Gilead partnered with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) to help reduce HIV infections among girls in sub-Saharan countries.
  • The company partnered with public health agencies, NGOs, universities and defense agencies on the clinical trials for the treatment of Ebola.
  • Gilead developed a $100 million, 10-year commitment initiative (COMPASS) to help tackle HIV/AIDS in the Southern part of U.S.
  • Through the Gilead HIV Age Positively initiative, the company plans to improve care, provide education, and inform policy for people who are living with HIV.

Research Strategy

It should be noted that older sources were used in our research in order to provide a comprehensive history of Gilead Sciences as most recent sources (2-year period) did not have the information needed to address some parts of the research especially in aspects of the company's mergers and acquisitions.
Part
02
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Part
02

Overall Organizational Structure - Gilead

An exhaustive search did not reveal the organizational structure or specific key people that report to the nine executives. Specific individuals within the organization that report to the executives is not publicly available information. Information regarding their respective areas of responsibility provided some general insight into the types of people that would report to them according to a general organizational structure of pharmaceutical companies is provided below.

Daniel O'Day

  • There are nine members of senior membership. Daniel O'Day is the Chairman and Chief Executive Officer.
  • As CEO and chairman, all executives report to Daniel O'Day, including the following eight senior management executives.
  • In general, after a pharmaceutical drug is commercialized the companies work with intermediaries to sell the drugs through various channels such as D2C and pharmaceutical companies.

Andrew Dickinson

William A Lee, PhD

  • Lee is the executive vice president of research and is director of the company's product development. He is responsible for the expansion of company research and pre-clinical activities across therapeutic areas. The range of pre-clinical activities that he is responsible for overseeing include "HIV, liver diseases, hematology and oncology, inflammation and respiratory diseases and cardiovascular conditions".
  • Leaders for research and development for pharmaceutical companies oversee the activities of the "Research Scientist, Clinical Research Specialist, Research Assistant, Clinical Research Scientist". Overseeing clinical trials involves reporting from job titles such as the "Research Investigator, Clinical Trials Research Associate, Clinical Research Coordinator, Clinical Cell Therapy Tech".

Jyoti Mehra

  • Mehra is the head of the global Human Resources for Gilead. She leads people strategy, evaluates team performance, and develops their approach to attract talent and talent development. All Human Resources directors would report to her.
  • She is the Human Resources leader for the company's global, commercial, general and administrative functions.
  • A LinkedIn job posting for human resource directors reveal that the candidates would report directly to senior management. Human resource managers report to the directors.

Johanna Mercier

  • Mercier is the head of the company's Commercial department and is responsible for product commercialization around the world. She recently joined the company in July 2019.
  • Product commercialization would likely require interaction with job titles such as the Production Chemist, Pharmaceutical Process Engineer, Pharmaceutical Manufacturing Engineer, Biotech Production Specialist Quality Assurance Specialist, Warehouse Material Handler, and Distribution Technician.

Brett A Pletcher

  • Pletcher is the Executive Vice President and General Counsel, and he serves as the Corporate Secretary. He oversees the legal organization and compliance efforts of promotions and interactions with healthcare professionals.
  • As the leader of compliance efforts in interactions with healthcare professionals, those job titles that would report to Pletcher include Quality Assurance Specialist, Warehouse Material Handler, Distribution Technician and Medical Information Specialist, Product Compliant Specialist, Medical Writer, Medical Editor, and Clinical Operations Document Specialist.
  • A LinkedIn job posting for a pharmaceutical team lead reveals that they have daily contact with Compliance, Inventory Control and Maintenance and they make sure that equipment and materials are ready and available.
  • Most of the time, drug distribution is carried out by third parties that link manufacturers with retailers.

Christi Shaw

Robin L Washington

Taiyin Yang, PhD

  • Yang is the Executive Vice President in charge of Pharmaceutical Development and Manufacturing. She is given to be responsible for the "chemistry, manufacturing and control operations of small molecules and biologics encompassing process development, production, supply chain management, analytical operations, laboratory information and quality assurance" for the company's investigational and commercial products.
  • Since she is in charge of Pharmaceutical Development and Manufacturing, job titles that would report to her include Production Chemist, Pharmaceutical Process Engineer, Pharmaceutical Manufacturing Engineer, Biotech Production Specialist, Research Scientist, Clinical Research Specialist, Research Assistant, and Clinical Research Scientists.

Strategy

We first analyzed the company's website and obtained information regarding the top nine executives. This search revealed what the executives were in charge of but did not reveal any information regarding specifically who reports to the executives. Gilead Science's LinkedIn profile provides a lot of the people that work for the company but did not reveal any organizational hierarchy.

A direct search for the organizational structure of Gilead Sciences did not reveal any available information. The Official Board provides an organizational chart provides the name of the board and shows what departments report to the executives, however it is only available after signing up for a free subscription. We did try this option by signing up for a free subscription, but it still does not allow users to view the information without upgrading to a premium account. This source may be useful for this research if a premium account is purchased.

Next, we searched the investor relations information like the company's annual reports and other news releases for information regarding their organizational structure or hints as to who reports to the executives. This search also did not yield any results.

Trying another strategy, we searched Gilead's website and job postings for information that may reveal the corporate organizational structure or the names of key people that candidates would report to, but this strategy was also unsuccessful.

As a final approach, we conducted a search for the general organizational structure of companies like Gilead to identify generic job titles that report to the different types of executives, and we tried to identify the individuals that filled those roles for Gilead. We located information regarding the organization chart of pharmaceutical companies such as Gilead and job titles that serve certain functions. We grouped those to match them to the specific department for each of the identified senior management executives. We conducted internet searches and LinkedIn searches for Gilead and the job titles that were revealed by the report to try to reveal specific individuals that reported to the executives but this search mostly revealed job postings and did not reveal the actual players.
Part
03
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Part
03

Key Products - Gilead

Gilead has 27 key products which are used in the treatment of HIV/AIDS infection, liver diseases, hematology, respiratory diseases, cardiovascular diseases, and other related diseases.

HIV/AIDS Products

  • Atripla: Atripla is a prescription medicine used alone or in combination with other anti-HIV-1 medicines to treat people with HIV-1 infection and weighing less than 40kg.
  • Biktarvy: Biktarvy is used in the treatment of HIV-1. The drug is a complete, 1-pill, once-a-day prescription medicine used either by people who have never taken HIV-1 pills before, or people who are replacing their current HIV-1 medications.
  • Complera: Complera is a combination of emtricitabine, rilpivirine, and tenofovir diisopropyl fumarate used for the treatment of HIV-1 infection in patients.
  • Descovy: Descovy is used in combination with other HIV-1 medicines to treat HIV-1 in people who weigh at least 35kg.
  • Emtriva: Emtriva is used in conjunction with other antiretroviral medicinal products for the treatment of HIV-1.
  • Genvoya: Genvoya is used without other antiviral medicines to treat HIV-1 in children and adults weighing less than 25kg.
  • Odefsey: Odefsey is used to treat HIV-1 in people who are 12 years of age and older.
  • Stribild: Stribild is used without other antiretroviral medicines to treat HIV-1 in people 12 years of age and older.
  • Truvada: Truvada is used with other anti-HIV-1 drugs in the treatment of HIV-1 in adults and children who weigh at least 17kg. The medicine also helps to reduce the risk of getting HIV-1 infection when the medicines are in the bloodstream before exposure to HIV-1.
  • Tybost: This drug is used to increase the levels of specific HIV protease inhibitors.
  • Viread: Viread can be used with anti-HIV-1 medicines to treat HIV-1 infection in adults and children aged two years or older weighing at least 10kg.

Liver Disease Products

  • Epclusa: Epclusa is used in the treatment of adults with chronic hepatitis C virus genotype 1,2,4,5, or 6 infections.
  • Harvoni: Harvoni is a medicine used in the treatment of chronic hepatitis C virus in adults and children aged three years or older.
  • Hepsera: Hepsera is a prescription medicine used to treat people 12 years of age and older with chronic hepatitis B virus. The medication is not for use by children under 12 years of age.
  • Sovaldi: Sovaldi is used in combination with ribavirin to treat children three years of age and older with chronic HCV genotype 2 or 3 infections.
  • Vemlidy: Vemlidy is used in the treatment of chronic hepatitis B virus in adults with stable liver disease.
  • Viread: In addition to being used as a treatment prescription for HIV-1 infection, Viread is also used to treat HBV infection in adults and children 2 years of age and older who weigh at least 10kg.
  • Vosevi: Vosevi is a prescription medicine used in combination with compensated cirrhosis or without cirrhosis in the treatment of chronic hepatitis C virus infection in adults.

Hematology/Oncology/Cell Therapy Products

  • Yescarta: Yescarta is used in the treatment of non-Hodgkin lymphoma. The medication is used after the failure of at least two other kinds of treatment.
  • Zydelig: Zydelig is used in combination with rituximab to treat people with chronic lymphocytic leukemia (CLL). It is also used to treat people with follicular B-cell non-Hodgkin lymphoma.

Cardiovascular Diseases Products

  • Letairis: Letairis is a prescription medicine used in the treatment of pulmonary arterial hypertension. When taken in combination with tadalafil, Letairis can reduce the risk of hospitalization due to worsening pulmonary arterial hypertension.
  • Lexiscan: Lexiscan is used in pharmacologic stress testing.
  • Ranexa: Ranexa is a prescription medicine used in the treatment of chronic angina. The medicine can be used in combination with other heart problems and blood pressure control medications.

Inflammation/Respiratory Diseases Products

  • Cayston: Cayston is used to improve breathing in people with cystic fibrosis. Cayston is an inhaled antibiotic only used for infections caused by bacteria.
  • Tamiflu: The prescription medicine is used in the "treatment of uncomplicated acute illness due to influenza infection in patients one year and older who have been symptomatic for no more than two days".

Other Medicines

  • AmBisome: AmBisome is an anti-fungal medication used in the treatment of Cryptococcal Meningitis in HIV infected patients; treatment of patients with Aspergillus species, Candida species or Cryptococcus species infections.
  • Macugen: Macugen is available in injection form for the treatment of neovascular age-related macular degeneration.
Part
04
of four
Part
04

Key Products in the Pipeline - Gilead

Gilead has 37 products that are in different development phases for the treatments of HIV/AIDS, liver diseases, hematology, respiratory-related diseases. 8 of the pipeline products are in Phase 3 stage, 18 are in the Phase 2 stage, and 11 are in the Phase 1 stage of clinical trials.

HIV/AIDS Products in Pipeline

  • Emtricitabine and tenofovir alafenamide: The product is used in combination with other HIV medications to help control HIV infection by decreasing the amount of HIV in the body. Emtricitabine and tenofovir alafenamide is in phase 3.
  • GS-6207 (Capsid Inhibitor): The medication is an investigational long-acting antiretroviral agent, novel, selective, first-in-class inhibitor of HIV capsid function. The drug is in Phase 1.
  • Elipovimab (bNab): Gilead Sciences are developing Elipovimab for treatment of HIV infections. The products are in Phase 1.
  • Vesatolimod (TLR-7 agonist): Vesatolimod is in the Phase 1 stage of development by Gilead. The drug is being developed for the treatment of HIV/AIDS.

Liver Disease Products in Pipeline

Hematology/Oncology/Cell Therapy Products in Pipeline

Inflammation/Respiratory Diseases Products in Pipeline

Other Medicines in Pipeline

  • Remdesivir (GS-5734, Nuc inhibitor): Remdesivir (GS 5734) is a small molecule and monophosphoramidate prodrug of adenine nucleotide analogue, that is being developed by Gilead Sciences in the Ebola virus treatment. The drug is in Phase 2 stage of clinical trials.

Sources
Sources

From Part 01