07.16.21
Headquarters: London, UK
twitter.com/GSK
www.gsk.com
Headcount: 99,437
Year Established: 2020
Pharma Revenues: $32,637 (flat)
Net Income: $8,673 (+26%)
R&D: $6,922 (+17%)
TOP SELLING DRUGS
In early 2020, GlaxoSmithKline (GSK) started a two-year plan to separate into two new companies: New GSK, a biopharma company focused on specialty medicines and vaccines with an R&D approach targeting the immune system, the use of human genetics and new technologies; and a new consumer healthcare organization. The company said it is on track for separation into new standalone Biopharma and Consumer Healthcare entities in 2022.
Together, GSK’s Pharmaceutical and Vaccines segments generated $32.6 billion of revenue in 2020, which was flat compared to the year prior. New and specialty products drove growth with sales of $13.4 billion, up 11%—this group of products now account for more than half of pharmaceutical sales. Strong sales performance from key growth drivers in HIV, respiratory, oncology helped offset disruption from COVID-19 to adult vaccinations.
Pharmaceuticals segment turnover in the year was $23.5 billion, down 3%. Respiratory sales were up 22% to $5.2 billion, on growth of Trelegy, Nucala and Relvar/Breo. HIV sales were flat at $6.7 billion, with growth in Juluca and Dovato partly offset by declines in Tivicay and Triumeq. Sales of established pharmaceuticals declined 16% to $10 billion.
In the vaccines segment, turnover declined 2% to $9.2 billion, primarily driven by the adverse impact of the COVID-19 pandemic on Hepatitis vaccines, DTPa-containing vaccines, Synflorix and Bexsero, together with the divestment of Rabipur and Encepur. This decline was partly offset by higher sales of Influenza vaccines across all regions and by Shingrix growth in Europe, China and the U.S. together with a strong performance from Cervarix in China.
Covid-19 vaccine
In August 2020, GSK and Sanofi entered an agreement with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology.
The U.S. government through its Operation Warp Speed is providing up to $2.1 billion, more than half of which is to support development of the vaccine, including clinical trials, with the remainder used for manufacturing scale up and delivery of an initial 100 million doses of the vaccine.
As of May 2021, Sanofi and GSK initiated a global Phase III clinical efficacy study of the vaccine candidate. The two-stage trial design is evaluating vaccine formulations targeting original D.614 virus as well as B.1.351 variant, in diverse geographies with multiple circulating variants. A booster study program has also begun to complement the Phase III trial. Pending positive Phase III outcomes and regulatory reviews, the vaccine could be approved in the fourth quarter of 2021. Manufacturing started within weeks of the Phase III trial announcement to enable rapid access to the vaccine if approved.
The Phase III study follows the interim Phase 2 results which showed that the adjuvanted recombinant COVID-19 vaccine candidate achieved high rates of neutralizing antibody responses in all adult age groups, with 95 to 100% seroconversion rates. After a single injection, high neutralizing antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.
In another Covid deal, GSK and CureVac entered €150 million collaboration to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. GSK is supporting the manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine candidate CVnCoV in 2021. The goal is to offer broader protection against a variety of different SARS-CoV2 variants, and to enable a quick response to new variants potentially emerging in the future. The development program started in February 2021, with the target of introducing the vaccine in 2022.
Pipeline approvals
GSK made significant progress across its biopharma portfolio, with nine major GSK drug candidates gaining regulatory approval. In the infectious disease portfolio, GSK received approvals in HIV for a first-in-class attachment inhibitor, Rukobia, in the U.S. and Europe, and for the long-acting regimen, Cabenuva, in Canada, the U.S. and Europe, where it is licensed as Vocabria + Rekambys.
The firm also received European regulatory approval to extend the use of several of its vaccines against infectious diseases: Shingrix, to expand its use from people aged over 50 to those over 18 who are at increased risk of shingles; Boostrix, a tetanus, diphtheria, and pertussis vaccine, received an expanded indication to include maternal immunization; and for Bexsero, a Europe-wide label update for its 2+1 schedule starting with infants of two months.
In oncology GSK received significant U.S. and European approvals, first for Zejula, which was approved for an expanded indication in ovarian cancer, and secondly for Blenrep, a first-in-class anti-BCMA (B-cell maturation antigen) treatment for multiple myeloma. In respiratory, Nucala, a first-in-class, anti-IL5 biologic, was approved in the U.S. for hypereosinophilic syndrome, and Trelegy Ellipta, a once-daily single inhaler triple therapy, was approved in the U.S. for asthma. Also, Duvroq, for chronic kidney disease-related anaemia, was approved in Japan while Benlysta was approved in the U.S. for an expanded indication in lupus nephritis.
Advanced technologies partnerships
In 2020 GSK sharpened its advanced technologies initiatives by establishing a London AI hub and forming two new collaborations in human genetics and genomics. The AI hub team will use biomedical information, AI methods and advanced computing platforms to unlock new potential from GSK’s genetic and clinical data. They will use the dedicated hub to work and partner with leading companies and AI institutions, including NVIDIA and Silicon Valley start-up Cerebras.
On the AI front GSK is also supporting PhD students at the University of Cambridge's new Center for AI and Medicine, which will provide GSK with a talent pipeline for the coming five years and will shape the next generation of practitioners.
During the year GSK also formed a new five-year research collaboration with one of the world’s leading genetics and functional genomic centers, the Broad Institute, in Cambridge, MA. Additionally, in December 2020, the firm announced with Ahren Innovation Capital that it will co-lead a Series A investment in Adrestia Therapeutics, a UK-based biotechnology company using cutting-edge molecular biology to develop precision medicines. Adrestia’s Disease Rebalancing Platform uses synthetic viability to identify phenotypic and molecular imbalances of disease as the basis of novel drug discovery. GSK is also entering into a multi-year agreement with Adrestia on up to five projects.
CDMO deals
During 2020 GSK reduced its manufacturing footprint when it parted ways with sites in Poland and Canada. With the contract development and manufacturing organization (CDMO) Delpharm, GSK struck a deal in October under which Delpharm acquired the Poznan manufacturing facility in Poland. The transaction includeds ownership of GSK’s Poznan manufacturing site, including all facilities and around 700 manufacturing employees, transfer over to Delpharm. Delpharm will continue to manufacture, under contract, the existing GSK product line for a minimum of five years, while GSK will remain the owner and marketing authorization holder of these products.
Earlier in the year, in March 2020, GSK entered an agreement under which the CDMO Bora Pharmaceuticals acquired GSK’s Mississauga, Ontario (Canada) facility. The GSK facility produces approximately 50 different products for over 100 markets worldwide and employs approximately 400 manufacturing staff. Bora Pharmaceuticals will continue to manufacture, under contract, the existing GSK product line for a minimum of five years.
In another CDMO deal, GSK inked a deal with Samsung Biologics to secure additional manufacturing capacity for its biopharmaceutical portfolio. Under the terms of the agreement, Samsung Biologics will provide GSK with additional capacity for large-scale biopharmaceutical product manufacturing. This capacity will be flexible depending on GSK's future needs and will supplement GSK's existing manufacturing network. The agreement is worth more than $231 million over the next eight years. It will initially cover commercial production of Benlysta (belimumab), with technology transfer starting in 2020 and first commercial supply expected in 2022. The intention is to expand to additional specialty-care products in the future.
twitter.com/GSK
www.gsk.com
Headcount: 99,437
Year Established: 2020
Pharma Revenues: $32,637 (flat)
Net Income: $8,673 (+26%)
R&D: $6,922 (+17%)
TOP SELLING DRUGS
Drug | Indication | 2020 Sales | (+/-%) |
Triumeq | HIV | $3,17 | -3% |
Shingrix | shingles prophylaxis | $2,736 | 18% |
Advair | asthma, COPD | $2,112 | -4% |
Tivicay | HIV | $2,101 | -1% |
Breo | Ellipta COPD | $1,546 | 25% |
Nucala | asthma | $1,367 | 39% |
Trelegy Ellipta | asthma | $1,126 | 58% |
Ventolin | asthma | $1,080 | -10% |
Fluarix / FluLaval | influenza | $1,008 | 35% |
Benlysta | lupus | $989 | 17% |
In early 2020, GlaxoSmithKline (GSK) started a two-year plan to separate into two new companies: New GSK, a biopharma company focused on specialty medicines and vaccines with an R&D approach targeting the immune system, the use of human genetics and new technologies; and a new consumer healthcare organization. The company said it is on track for separation into new standalone Biopharma and Consumer Healthcare entities in 2022.
Together, GSK’s Pharmaceutical and Vaccines segments generated $32.6 billion of revenue in 2020, which was flat compared to the year prior. New and specialty products drove growth with sales of $13.4 billion, up 11%—this group of products now account for more than half of pharmaceutical sales. Strong sales performance from key growth drivers in HIV, respiratory, oncology helped offset disruption from COVID-19 to adult vaccinations.
Pharmaceuticals segment turnover in the year was $23.5 billion, down 3%. Respiratory sales were up 22% to $5.2 billion, on growth of Trelegy, Nucala and Relvar/Breo. HIV sales were flat at $6.7 billion, with growth in Juluca and Dovato partly offset by declines in Tivicay and Triumeq. Sales of established pharmaceuticals declined 16% to $10 billion.
In the vaccines segment, turnover declined 2% to $9.2 billion, primarily driven by the adverse impact of the COVID-19 pandemic on Hepatitis vaccines, DTPa-containing vaccines, Synflorix and Bexsero, together with the divestment of Rabipur and Encepur. This decline was partly offset by higher sales of Influenza vaccines across all regions and by Shingrix growth in Europe, China and the U.S. together with a strong performance from Cervarix in China.
Covid-19 vaccine
In August 2020, GSK and Sanofi entered an agreement with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology.
The U.S. government through its Operation Warp Speed is providing up to $2.1 billion, more than half of which is to support development of the vaccine, including clinical trials, with the remainder used for manufacturing scale up and delivery of an initial 100 million doses of the vaccine.
As of May 2021, Sanofi and GSK initiated a global Phase III clinical efficacy study of the vaccine candidate. The two-stage trial design is evaluating vaccine formulations targeting original D.614 virus as well as B.1.351 variant, in diverse geographies with multiple circulating variants. A booster study program has also begun to complement the Phase III trial. Pending positive Phase III outcomes and regulatory reviews, the vaccine could be approved in the fourth quarter of 2021. Manufacturing started within weeks of the Phase III trial announcement to enable rapid access to the vaccine if approved.
The Phase III study follows the interim Phase 2 results which showed that the adjuvanted recombinant COVID-19 vaccine candidate achieved high rates of neutralizing antibody responses in all adult age groups, with 95 to 100% seroconversion rates. After a single injection, high neutralizing antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.
In another Covid deal, GSK and CureVac entered €150 million collaboration to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. GSK is supporting the manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine candidate CVnCoV in 2021. The goal is to offer broader protection against a variety of different SARS-CoV2 variants, and to enable a quick response to new variants potentially emerging in the future. The development program started in February 2021, with the target of introducing the vaccine in 2022.
Pipeline approvals
GSK made significant progress across its biopharma portfolio, with nine major GSK drug candidates gaining regulatory approval. In the infectious disease portfolio, GSK received approvals in HIV for a first-in-class attachment inhibitor, Rukobia, in the U.S. and Europe, and for the long-acting regimen, Cabenuva, in Canada, the U.S. and Europe, where it is licensed as Vocabria + Rekambys.
The firm also received European regulatory approval to extend the use of several of its vaccines against infectious diseases: Shingrix, to expand its use from people aged over 50 to those over 18 who are at increased risk of shingles; Boostrix, a tetanus, diphtheria, and pertussis vaccine, received an expanded indication to include maternal immunization; and for Bexsero, a Europe-wide label update for its 2+1 schedule starting with infants of two months.
In oncology GSK received significant U.S. and European approvals, first for Zejula, which was approved for an expanded indication in ovarian cancer, and secondly for Blenrep, a first-in-class anti-BCMA (B-cell maturation antigen) treatment for multiple myeloma. In respiratory, Nucala, a first-in-class, anti-IL5 biologic, was approved in the U.S. for hypereosinophilic syndrome, and Trelegy Ellipta, a once-daily single inhaler triple therapy, was approved in the U.S. for asthma. Also, Duvroq, for chronic kidney disease-related anaemia, was approved in Japan while Benlysta was approved in the U.S. for an expanded indication in lupus nephritis.
Advanced technologies partnerships
In 2020 GSK sharpened its advanced technologies initiatives by establishing a London AI hub and forming two new collaborations in human genetics and genomics. The AI hub team will use biomedical information, AI methods and advanced computing platforms to unlock new potential from GSK’s genetic and clinical data. They will use the dedicated hub to work and partner with leading companies and AI institutions, including NVIDIA and Silicon Valley start-up Cerebras.
On the AI front GSK is also supporting PhD students at the University of Cambridge's new Center for AI and Medicine, which will provide GSK with a talent pipeline for the coming five years and will shape the next generation of practitioners.
During the year GSK also formed a new five-year research collaboration with one of the world’s leading genetics and functional genomic centers, the Broad Institute, in Cambridge, MA. Additionally, in December 2020, the firm announced with Ahren Innovation Capital that it will co-lead a Series A investment in Adrestia Therapeutics, a UK-based biotechnology company using cutting-edge molecular biology to develop precision medicines. Adrestia’s Disease Rebalancing Platform uses synthetic viability to identify phenotypic and molecular imbalances of disease as the basis of novel drug discovery. GSK is also entering into a multi-year agreement with Adrestia on up to five projects.
CDMO deals
During 2020 GSK reduced its manufacturing footprint when it parted ways with sites in Poland and Canada. With the contract development and manufacturing organization (CDMO) Delpharm, GSK struck a deal in October under which Delpharm acquired the Poznan manufacturing facility in Poland. The transaction includeds ownership of GSK’s Poznan manufacturing site, including all facilities and around 700 manufacturing employees, transfer over to Delpharm. Delpharm will continue to manufacture, under contract, the existing GSK product line for a minimum of five years, while GSK will remain the owner and marketing authorization holder of these products.
Earlier in the year, in March 2020, GSK entered an agreement under which the CDMO Bora Pharmaceuticals acquired GSK’s Mississauga, Ontario (Canada) facility. The GSK facility produces approximately 50 different products for over 100 markets worldwide and employs approximately 400 manufacturing staff. Bora Pharmaceuticals will continue to manufacture, under contract, the existing GSK product line for a minimum of five years.
In another CDMO deal, GSK inked a deal with Samsung Biologics to secure additional manufacturing capacity for its biopharmaceutical portfolio. Under the terms of the agreement, Samsung Biologics will provide GSK with additional capacity for large-scale biopharmaceutical product manufacturing. This capacity will be flexible depending on GSK's future needs and will supplement GSK's existing manufacturing network. The agreement is worth more than $231 million over the next eight years. It will initially cover commercial production of Benlysta (belimumab), with technology transfer starting in 2020 and first commercial supply expected in 2022. The intention is to expand to additional specialty-care products in the future.