07.16.21
Headquarters: Foster City, CA
twitter.com/gileadsciences
www.gilead.com
Headcount: 13,000
Year Established: 1987
Revenues: $24,689 (+10%)
Net Income: $123 (-98%)
R&D: $5,039 (+24%)
TOP SELLING DRUGS
In 2020 Gilead reported revenues of $24.7 billion, up 10% primarily due to the launch of Veklury (remdesivir). Product sales excluding Veklury for year decreased 3% due to the continued effects of Covid-19 on Gilead’s HIV and hepatitis C virus (HCV) franchises, as well as the expected decline in sales of Truvada-based products due to the loss of exclusivity of Truvada and Atripla in the U.S. in October 2020. Despite these challenges, Gilead continues to make pipeline progress, along with efforts to diversify its portfolio, and further expand into immune-oncology with significant investments.
Looking ahead, in the first quarter of 2021 revenues were up 16%, driven by Veklury sales, cell therapy growth with Yescarta and the U.S. launch of Tecartus in the third quarter 2020, the first full quarter recognition of Trodelvy sales, and Hepatitis B virus (HBV) growth with Vemlidy.
Covid news
As one of the foremost anti-viral experts in the industry, it’s not a surprise that Gilead succeeded in being the first company to provide a potential therapy for Covid-19. Veklury was initially approved in Japan on May 7, 2020 under an exceptional approval pathway for patients infected with SARS-CoV-2. Later that year, it was authorized by the FDA for emergency use to treat Covid-19. Finally, in October 2020, the FDA approved Veklury for the treatment of patients with Covid-19 requiring hospitalization, making it the first and only approved Covid-19 treatment in the U.S.
As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes Covid-19. The approval was based on three trials, which showed that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with Covid-19. By the end of 2020, one million people in the U.S. had received Veklury.
Approvals
In July 2020, Kite, a Gilead Company, was granted accelerated approval for Tecartus, the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The approval of this one-time therapy follows a priority review and FDA Breakthrough Therapy Designation and is based on the ZUMA-2 study in which 87 percent of patients responded to a single infusion of Tecartus, including 62 percent of patients achieving a complete response (CR). Tecartus will be manufactured in Kite’s commercial manufacturing facility in El Segundo, CA.
In September, the FDA granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational anti-CD47 monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome (MDS). The designation for magrolimab was based on positive results of an ongoing Phase 1b study, which evaluated magrolimab in combination with azacitidine in previously untreated intermediate, high and very high-risk MDS.
The FDA also granted accelerated approval to Yescarta for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The approval makes Yescarta the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent follicular lymphoma and is based on results from ZUMA-5, a single-arm, open-label study in which 91 percent of patients responded to Yescarta, including an estimated 74 percent in a continued remission at 18 months.
Most recently, the FDA approved Trodelvy for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is supported by data from a Phase 3 study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death. Trodelvy also extended median overall survival to 11.8 months vs. 6.9 months, representing a 49% reduction in the risk of death.
Furthermore, the FDA approved Trodelvy for use in adults with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. The accelerated approval was based on data from a Phase 2 study. Of the 112 patients who were evaluable for efficacy, 27.7% of those treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response.
Acquisitions
Known for investing big in R&D, Gilead spent $25.7 billion on acquisitions in fiscal year 2020. In July 2020, the company invested $300 million to acquire a 49.9% equity interest in Tizona Therapeutics Inc., a privately held company developing first-in-class cancer immunotherapies. Gilead also received an exclusive option to acquire the remainder of Tizona for up to an additional $1.25 billion. The U.S. FDA recently cleared Tizona’s Investigational New Drug (IND) application for TTX-080.
In October 2020, Gilead acquired Immunomedics in a transaction valued at approximately $21 billion. The agreement provided Gilead with Trodelvy and represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio.
Gilead also acquired MYR, a German biotechnology company focused on therapeutics for the treatment of chronic hepatitis delta virus (HDV), for approximately $1.4 billion in cash, plus a potential future milestone payment of up to $357 million. Gilead gains Hepcludex (bulevirtide), which was conditionally approved by the European Medicines Agency for the treatment of chronic HDV infection in adults with compensated liver disease in July 2020. MYR has since launched Hepcludex in France, Germany and Austria, and continues to prepare for launch in certain other markets throughout 2021.
Collaborations
Gilead entered into several strategic partnerships during the year, especially in the field of oncology, an important new pillar of growth for the company. In August 2020, the company expanded a strategic collaboration with Tango Therapeutics focused on the discovery, development and commercialization of targeted immune evasion therapies for patients with cancer.
Also, Gilead entered an agreement with Jounce Therapeutics Inc., a company focused on novel cancer immunotherapies and predictive biomarkers, to exclusively license its JTX-1811 program. JTX-1811 is a monoclonal antibody designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory cells.
In December, Gilead and Galapagos NV amended their existing arrangement for the commercialization and development of Jyseleca (filgotinib). Following an FDA Type A meeting, Gilead decided not to advance Jyseleca for the treatment of Rheumatoid Arthritis. Under the new arrangement, Galapagos will assume sole responsibility in Europe for filgotinib in RA, where 200 mg and 100 mg doses are approved for moderate to severe RA, and in all future indications.
In January 2021 Kite entered a research collaboration with Oxford BioTherapeutics Ltd. (OBT) to evaluate five novel targets for a number of hematologic and solid tumor indications. OBT will validate five oncology targets and generate antibodies against these targets. Kite and Gilead will have the exclusive right to develop and commercialize therapies based on these targets or antibodies.
Also in January, Gilead and Vir Biotechnology entered a clinical collaboration to evaluate therapeutic combination strategies aimed at developing a functional cure for chronic hepatitis B virus.
An agreement with Gritstone Oncology aims to develop a vaccine-based immunotherapy as a curative treatment for HIV infection. The alliance will leverage Gritstone’s prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead.
Recently, Gilead and Merck agreed to co-develop and co-commercialize long-acting treatments in HIV that combine Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen with the potential to provide new, meaningful treatment options for HIV. The first clinical studies of the oral combination are expected to begin in the second half of 2021.
Gilead also expanded its non-alcoholic steatohepatitis (NASH) alliance with Novo Nordisk. The companies will conduct a Phase 2 study to investigate the safety and efficacy of Novo’s semaglutide and a fixed-dose combination of Gilead’s FXR agonist cilofexor and investigational ACC inhibitor firsocostat, alone and in combination in compensated cirrhosis due to NASH.
twitter.com/gileadsciences
www.gilead.com
Headcount: 13,000
Year Established: 1987
Revenues: $24,689 (+10%)
Net Income: $123 (-98%)
R&D: $5,039 (+24%)
TOP SELLING DRUGS
Drug | Indication | 2020 Sales | (+/-%) |
Biktarvy | HIV-1 treatment | $7,259 | 53% |
Genvoya | HIV treatment | $3,338 | -15% |
Veklury | Covid-19 trearment | $2,811 | n/a |
Descovy | Pre-exposure prophylaxis (PrEP) | $1,861 | 24% |
Odefsey | Hepatitis C treatment | $1,672 | 1% |
Truvada | HIV treatment | $1,672 | -56% |
Sofosbuvir/Velpatasvir | Hepatitis C treatment | $1,599 | -19% |
Vemlidy | Hepatitis B treatment | $657 | 35% |
Yescarta | B-Cell Lymphoma treatment | $563 | 23% |
AmBisome | Fungal infections | $436 | 7% |
Atripla | HIV treatment | $349 | -42% |
Letairis | HIV treatment | $314 | -49% |
Ledipasvir | Hepatitis C treatment | $272 | -58% |
Complera | HIV treatment | $269 | -34% |
Stribild | HIV Treatment | $196 | -47% |
In 2020 Gilead reported revenues of $24.7 billion, up 10% primarily due to the launch of Veklury (remdesivir). Product sales excluding Veklury for year decreased 3% due to the continued effects of Covid-19 on Gilead’s HIV and hepatitis C virus (HCV) franchises, as well as the expected decline in sales of Truvada-based products due to the loss of exclusivity of Truvada and Atripla in the U.S. in October 2020. Despite these challenges, Gilead continues to make pipeline progress, along with efforts to diversify its portfolio, and further expand into immune-oncology with significant investments.
Looking ahead, in the first quarter of 2021 revenues were up 16%, driven by Veklury sales, cell therapy growth with Yescarta and the U.S. launch of Tecartus in the third quarter 2020, the first full quarter recognition of Trodelvy sales, and Hepatitis B virus (HBV) growth with Vemlidy.
Covid news
As one of the foremost anti-viral experts in the industry, it’s not a surprise that Gilead succeeded in being the first company to provide a potential therapy for Covid-19. Veklury was initially approved in Japan on May 7, 2020 under an exceptional approval pathway for patients infected with SARS-CoV-2. Later that year, it was authorized by the FDA for emergency use to treat Covid-19. Finally, in October 2020, the FDA approved Veklury for the treatment of patients with Covid-19 requiring hospitalization, making it the first and only approved Covid-19 treatment in the U.S.
As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes Covid-19. The approval was based on three trials, which showed that treatment with Veklury resulted in clinically meaningful improvements across multiple outcome assessments compared with placebo in hospitalized patients with Covid-19. By the end of 2020, one million people in the U.S. had received Veklury.
Approvals
In July 2020, Kite, a Gilead Company, was granted accelerated approval for Tecartus, the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The approval of this one-time therapy follows a priority review and FDA Breakthrough Therapy Designation and is based on the ZUMA-2 study in which 87 percent of patients responded to a single infusion of Tecartus, including 62 percent of patients achieving a complete response (CR). Tecartus will be manufactured in Kite’s commercial manufacturing facility in El Segundo, CA.
In September, the FDA granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational anti-CD47 monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome (MDS). The designation for magrolimab was based on positive results of an ongoing Phase 1b study, which evaluated magrolimab in combination with azacitidine in previously untreated intermediate, high and very high-risk MDS.
The FDA also granted accelerated approval to Yescarta for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The approval makes Yescarta the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent follicular lymphoma and is based on results from ZUMA-5, a single-arm, open-label study in which 91 percent of patients responded to Yescarta, including an estimated 74 percent in a continued remission at 18 months.
Most recently, the FDA approved Trodelvy for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is supported by data from a Phase 3 study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death. Trodelvy also extended median overall survival to 11.8 months vs. 6.9 months, representing a 49% reduction in the risk of death.
Furthermore, the FDA approved Trodelvy for use in adults with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. The accelerated approval was based on data from a Phase 2 study. Of the 112 patients who were evaluable for efficacy, 27.7% of those treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response.
Acquisitions
Known for investing big in R&D, Gilead spent $25.7 billion on acquisitions in fiscal year 2020. In July 2020, the company invested $300 million to acquire a 49.9% equity interest in Tizona Therapeutics Inc., a privately held company developing first-in-class cancer immunotherapies. Gilead also received an exclusive option to acquire the remainder of Tizona for up to an additional $1.25 billion. The U.S. FDA recently cleared Tizona’s Investigational New Drug (IND) application for TTX-080.
In October 2020, Gilead acquired Immunomedics in a transaction valued at approximately $21 billion. The agreement provided Gilead with Trodelvy and represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio.
Gilead also acquired MYR, a German biotechnology company focused on therapeutics for the treatment of chronic hepatitis delta virus (HDV), for approximately $1.4 billion in cash, plus a potential future milestone payment of up to $357 million. Gilead gains Hepcludex (bulevirtide), which was conditionally approved by the European Medicines Agency for the treatment of chronic HDV infection in adults with compensated liver disease in July 2020. MYR has since launched Hepcludex in France, Germany and Austria, and continues to prepare for launch in certain other markets throughout 2021.
Collaborations
Gilead entered into several strategic partnerships during the year, especially in the field of oncology, an important new pillar of growth for the company. In August 2020, the company expanded a strategic collaboration with Tango Therapeutics focused on the discovery, development and commercialization of targeted immune evasion therapies for patients with cancer.
Also, Gilead entered an agreement with Jounce Therapeutics Inc., a company focused on novel cancer immunotherapies and predictive biomarkers, to exclusively license its JTX-1811 program. JTX-1811 is a monoclonal antibody designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory cells.
In December, Gilead and Galapagos NV amended their existing arrangement for the commercialization and development of Jyseleca (filgotinib). Following an FDA Type A meeting, Gilead decided not to advance Jyseleca for the treatment of Rheumatoid Arthritis. Under the new arrangement, Galapagos will assume sole responsibility in Europe for filgotinib in RA, where 200 mg and 100 mg doses are approved for moderate to severe RA, and in all future indications.
In January 2021 Kite entered a research collaboration with Oxford BioTherapeutics Ltd. (OBT) to evaluate five novel targets for a number of hematologic and solid tumor indications. OBT will validate five oncology targets and generate antibodies against these targets. Kite and Gilead will have the exclusive right to develop and commercialize therapies based on these targets or antibodies.
Also in January, Gilead and Vir Biotechnology entered a clinical collaboration to evaluate therapeutic combination strategies aimed at developing a functional cure for chronic hepatitis B virus.
An agreement with Gritstone Oncology aims to develop a vaccine-based immunotherapy as a curative treatment for HIV infection. The alliance will leverage Gritstone’s prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead.
Recently, Gilead and Merck agreed to co-develop and co-commercialize long-acting treatments in HIV that combine Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen with the potential to provide new, meaningful treatment options for HIV. The first clinical studies of the oral combination are expected to begin in the second half of 2021.
Gilead also expanded its non-alcoholic steatohepatitis (NASH) alliance with Novo Nordisk. The companies will conduct a Phase 2 study to investigate the safety and efficacy of Novo’s semaglutide and a fixed-dose combination of Gilead’s FXR agonist cilofexor and investigational ACC inhibitor firsocostat, alone and in combination in compensated cirrhosis due to NASH.