07.11.22
Headquarters: Indianapolis, IN
twitter.com/lillypad
www.lilly.com
Headcount: 36,190
Revenues: $28,318 (+15%)
Net Income: $5,582 (-10%)
R&D: $7,026 (+15%)
TOP SELLING DRUGS
In an eventful and productive year for Lilly, the company won several significant approvals, announced investments of $4.3 billion in manufacturing capacity, and acquired biotech Protomer Technologies for $1 billion. Lilly also received authorizations and orders for its Covid-19 antibodies, but the FDA later limited their use.
Lilly’s key growth products, Trulicity, Taltz, Verzenio, Jardiance, Olumiant, Emgality, Retevmo, Cyramza and Tyvyt, represented an impressive 61% of total revenue in the fourth quarter of 2021, excluding revenue from Covid-19 antibodies. For the year, worldwide revenue growth of 15% was driven by a 16 percent increase in volume boosted by worldwide revenues of $2.2 billion from Covid-19 antibodies.
Sales of top seller Trulicity were up 28% to $6.5 billion, while Humalog revenue was down 7% to $2.5 billion, primarily as a result of lower prices in the U.S., and with competition abound, the company expects a continued price decline. Taltz generated worldwide sales of $2.2 billion, an increase of 24%, while entry of generic competition for lung cancer treatment Alimta ate away at sales, which were down 33%.
Meanwhile, increased demand for breast cancer drug Verzenio saw sales increase 48%, generating worldwide revenues of $1.4 billion. With recent approvals, Verzenio now stands to compete with Pfizer’s market-leading Ibrance. In England the drug won backing from England’s National Institute for Health and Care Excellence expanding eligibility for routine coverage as a post-surgery treatment for early breast cancer at high risk of recurrence.
Olumiant (baricitinib) generated sales of $1.1 billion, an increase of 75%, partially driven by its use for the treatment of hospitalized Covid-19 patients. Meanwhile, Lilly and Incyte recently received approval from the FDA for Olumiant, as a once-daily pill to treat adults with severe alopecia areata (AA), becoming the first FDA-approved treatment for this condition. In the largest Phase 3 clinical program in AA completed to date, at 36 weeks 17-22% of patients taking Olumiant 2-mg and 32-35% of patients taking 4-mg achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo.
For the year, the Lilly’s Tyvyt revenue was up 35% to $418.1 million. The cancer drug Tyvyt is part of the company’s alliance with Innovent Biologics under which Lilly reports total sales with payments made to Innovent. In China, the PD-1 immunoglobulin G4 monoclonal antibody known as sintilimab, is approved for six cancer indications. The companies recently submitted an application for Tyvyt in first-line non-small cell lung cancer to the FDA, setting up the arrival of the first China-made PD-1 inhibitor in the U.S.
Over the past eight years, Lilly has delivered 17 new medicines, including Mounjaro (tirzepatide) for the treatment of type 2 diabetes, and aims to introduce four potential new medicines in the next two years. These new sites will support increased demand for existing products as well as support pipeline advances.
This past February, the company launched the Lilly Institute for Genetic Medicine, investing approximately $700 million to establish a state-of-the-art facility at a new site in the Boston. This investment – part of the company’s strategy to advance RNA based therapeutics – builds on the 2020 acquisition and expansion of Prevail Therapeutics, a NY-based gene therapy developer. Researchers in Boston and New York will leverage RNA and DNA-based technologies in an effort to develop genetic medicines with the potential to treat or prevent diseases.
Genetic medicines currently account for more than 20 percent of Lilly’s diabetes, immunology, and central nervous system research portfolio. Over the next five years, Lilly projects the Boston site will grow from 120 to more than 250 research biologists, chemists, data scientists and other experts in genetic medicine, while the New York site will grow to include up to 200 scientists.
Furthermore, in a transaction valued at more than $1 billion, Lilly acquired Protomer Technologies, a private biotech company leveraging its peptide- and protein-engineering platform to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity. Protomer’s next-generation protein therapeutics can sense molecular activators in the body, and its chemical biology-based platform enables the development of therapeutic peptides and proteins with tunable activity that can be controlled using small molecules. Protomer’s portfolio of therapeutic candidates include glucose-responsive insulins that can sense sugar levels in the blood and automatically activate as needed throughout the day.
A research pact with Entos Pharmaceuticals Inc. aims to support the development of therapies in multiple neurologic indications. Here Lilly gains exclusive rights to Entos’ Fusogenix nucleic acid delivery technology to develop products targeting the central and peripheral nervous system. This technology provides an opportunity for Lilly to access a novel delivery platform technology with the potential to solve a key delivery challenge for many nucleic acid therapeutic modalities.
Finally, another strategic alliance with QILU Regor Therapeutics Inc. aims to discover and develop novel therapies for metabolic disorders. Lilly will have a license to select Regor intellectual property with an option to extend the license. The agreement will allow each company to leverage both parties’ existing compounds and technologies globally.
Additionally, the FDA expanded the Emergency Use Authorization for bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients for the treatment of mild to moderate Covid-19 as well as post-exposure prophylaxis. The antibody combo was previously authorized by the FDA as the first and only neutralizing antibody therapy for emergency use in Covid-19 patients. However, the FDA has since limited authorized use of bamlanivimab and etesevimab due to the high frequency of the Omicron variant, noting the treatment is unlikely to be active against the omicron variant.
This past February, the U.S. Government signed a purchase agreement for 614,000 additional doses of Lilly’s bamlanivimab and etesevimab for the treatment or post-exposure prevention of Covid-19 for a total of $1.3 billion. There were approximately 435,000 doses delivered in fourth-quarter 2021 with most of the remaining doses already shipped in January 2022.
In a big win for Lilly, Verzenio (abemaciclib) in combination with endocrine therapy was approved for the adjuvant treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation. Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.
Also noteworthy, Lilly and partner Boehringer won approval for Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization in heart failure. The drug can now help address a significant unmet need for the approximately three million adults in the U.S. with preserved ejection fraction, a form of heart failure that has very limited treatment options.
Regulatory authorities have accepted Lilly’s New Drug Application in the U.S. and Japan, and Marketing Authorization Application in the EU, respectively, for tirzepatide for the treatment of type 2 diabetes. Lilly also submitted tirzepatide to six additional markets. Lilly initiated a rolling submission to the FDA for pirtobrutinib, seeking accelerated approval in mantle cell lymphoma, with expectations to complete the submission in 2022.
twitter.com/lillypad
www.lilly.com
Headcount: 36,190
Revenues: $28,318 (+15%)
Net Income: $5,582 (-10%)
R&D: $7,026 (+15%)
TOP SELLING DRUGS
| Drug | Indication | 2021 Sales | (+/-%) |
| Trulicity | diabetes | $6,472 | 28% |
| Humalog | diabetes | $2,453 | -7% |
| Covid-19 Antibodies | Covid-19 | $2,239 | n/m |
| Taltz | Psoriasis | $2,213 | 24% |
| Alimta | cancer | $2,061 | -12% |
| Jardiance | diabetes | $1,491 | 29% |
| Verzenio | breast cancer | $1,350 | 48% |
| Humulin | diabetes | $1,223 | -3% |
| Olumiant | rheumatoid arthritis | $1,115 | 75% |
| Cyramza | stomach cancer | $1,033 | 12% |
In an eventful and productive year for Lilly, the company won several significant approvals, announced investments of $4.3 billion in manufacturing capacity, and acquired biotech Protomer Technologies for $1 billion. Lilly also received authorizations and orders for its Covid-19 antibodies, but the FDA later limited their use.
Lilly’s key growth products, Trulicity, Taltz, Verzenio, Jardiance, Olumiant, Emgality, Retevmo, Cyramza and Tyvyt, represented an impressive 61% of total revenue in the fourth quarter of 2021, excluding revenue from Covid-19 antibodies. For the year, worldwide revenue growth of 15% was driven by a 16 percent increase in volume boosted by worldwide revenues of $2.2 billion from Covid-19 antibodies.
Sales of top seller Trulicity were up 28% to $6.5 billion, while Humalog revenue was down 7% to $2.5 billion, primarily as a result of lower prices in the U.S., and with competition abound, the company expects a continued price decline. Taltz generated worldwide sales of $2.2 billion, an increase of 24%, while entry of generic competition for lung cancer treatment Alimta ate away at sales, which were down 33%.
Meanwhile, increased demand for breast cancer drug Verzenio saw sales increase 48%, generating worldwide revenues of $1.4 billion. With recent approvals, Verzenio now stands to compete with Pfizer’s market-leading Ibrance. In England the drug won backing from England’s National Institute for Health and Care Excellence expanding eligibility for routine coverage as a post-surgery treatment for early breast cancer at high risk of recurrence.
Olumiant (baricitinib) generated sales of $1.1 billion, an increase of 75%, partially driven by its use for the treatment of hospitalized Covid-19 patients. Meanwhile, Lilly and Incyte recently received approval from the FDA for Olumiant, as a once-daily pill to treat adults with severe alopecia areata (AA), becoming the first FDA-approved treatment for this condition. In the largest Phase 3 clinical program in AA completed to date, at 36 weeks 17-22% of patients taking Olumiant 2-mg and 32-35% of patients taking 4-mg achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo.
For the year, the Lilly’s Tyvyt revenue was up 35% to $418.1 million. The cancer drug Tyvyt is part of the company’s alliance with Innovent Biologics under which Lilly reports total sales with payments made to Innovent. In China, the PD-1 immunoglobulin G4 monoclonal antibody known as sintilimab, is approved for six cancer indications. The companies recently submitted an application for Tyvyt in first-line non-small cell lung cancer to the FDA, setting up the arrival of the first China-made PD-1 inhibitor in the U.S.
Corporate investments
Lilly announced substantial investments to increase its manufacturing capacity for current and future medicines. Lilly plans to invest more than $500 million in a new site in Limerick, Ireland to expand the company’s manufacturing network for biologic active ingredients. Lilly also plans to invest more than $1 billion in a new site in Concord, NC to manufacture parenteral products and devices. Most recently, in May Lilly announced plans to expand its manufacturing footprint in Indiana with an investment of $2.1 billion in two new manufacturing sites for active ingredients and new therapeutic modalities, such as genetic medicines.Over the past eight years, Lilly has delivered 17 new medicines, including Mounjaro (tirzepatide) for the treatment of type 2 diabetes, and aims to introduce four potential new medicines in the next two years. These new sites will support increased demand for existing products as well as support pipeline advances.
This past February, the company launched the Lilly Institute for Genetic Medicine, investing approximately $700 million to establish a state-of-the-art facility at a new site in the Boston. This investment – part of the company’s strategy to advance RNA based therapeutics – builds on the 2020 acquisition and expansion of Prevail Therapeutics, a NY-based gene therapy developer. Researchers in Boston and New York will leverage RNA and DNA-based technologies in an effort to develop genetic medicines with the potential to treat or prevent diseases.
Genetic medicines currently account for more than 20 percent of Lilly’s diabetes, immunology, and central nervous system research portfolio. Over the next five years, Lilly projects the Boston site will grow from 120 to more than 250 research biologists, chemists, data scientists and other experts in genetic medicine, while the New York site will grow to include up to 200 scientists.
Furthermore, in a transaction valued at more than $1 billion, Lilly acquired Protomer Technologies, a private biotech company leveraging its peptide- and protein-engineering platform to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity. Protomer’s next-generation protein therapeutics can sense molecular activators in the body, and its chemical biology-based platform enables the development of therapeutic peptides and proteins with tunable activity that can be controlled using small molecules. Protomer’s portfolio of therapeutic candidates include glucose-responsive insulins that can sense sugar levels in the blood and automatically activate as needed throughout the day.
Alliances
Through several alliances, Lilly gained access to novel technologies for the development of therapies in oncology, neurologic indications, and metabolic disorders. Under a strategic collaboration with Foghorn Therapeutics Inc. for novel oncology targets, Lilly gains access to Foghorn’s Gene Traffic Control platform. Lilly will pay $300 million upfront and will invest $80 million in Foghorn.A research pact with Entos Pharmaceuticals Inc. aims to support the development of therapies in multiple neurologic indications. Here Lilly gains exclusive rights to Entos’ Fusogenix nucleic acid delivery technology to develop products targeting the central and peripheral nervous system. This technology provides an opportunity for Lilly to access a novel delivery platform technology with the potential to solve a key delivery challenge for many nucleic acid therapeutic modalities.
Finally, another strategic alliance with QILU Regor Therapeutics Inc. aims to discover and develop novel therapies for metabolic disorders. Lilly will have a license to select Regor intellectual property with an option to extend the license. The agreement will allow each company to leverage both parties’ existing compounds and technologies globally.
Regulatory updates
Lilly won several key approvals from the FDA, as well as authorizations for Covid. Most recently, the FDA issued an Emergency Use Authorization for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant. Bebtelovimab can now be used for the treatment of mild-to-moderate Covid-19 in adults and pediatric patients 12 and older, and those at high risk for progression to severe Covid-19. Pseudovirus and authentic virus testing demonstrate that bebtelovimab retains full neutralizing activity against Omicron and all other known variants of interest and concern, including BA.2.Additionally, the FDA expanded the Emergency Use Authorization for bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients for the treatment of mild to moderate Covid-19 as well as post-exposure prophylaxis. The antibody combo was previously authorized by the FDA as the first and only neutralizing antibody therapy for emergency use in Covid-19 patients. However, the FDA has since limited authorized use of bamlanivimab and etesevimab due to the high frequency of the Omicron variant, noting the treatment is unlikely to be active against the omicron variant.
This past February, the U.S. Government signed a purchase agreement for 614,000 additional doses of Lilly’s bamlanivimab and etesevimab for the treatment or post-exposure prevention of Covid-19 for a total of $1.3 billion. There were approximately 435,000 doses delivered in fourth-quarter 2021 with most of the remaining doses already shipped in January 2022.
In a big win for Lilly, Verzenio (abemaciclib) in combination with endocrine therapy was approved for the adjuvant treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation. Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.
Also noteworthy, Lilly and partner Boehringer won approval for Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization in heart failure. The drug can now help address a significant unmet need for the approximately three million adults in the U.S. with preserved ejection fraction, a form of heart failure that has very limited treatment options.
Regulatory authorities have accepted Lilly’s New Drug Application in the U.S. and Japan, and Marketing Authorization Application in the EU, respectively, for tirzepatide for the treatment of type 2 diabetes. Lilly also submitted tirzepatide to six additional markets. Lilly initiated a rolling submission to the FDA for pirtobrutinib, seeking accelerated approval in mantle cell lymphoma, with expectations to complete the submission in 2022.
