07.16.21
Headquarters: Indianapolis, IN
twitter.com/lillypad
www.lilly.com
Headcount: 34,000
Year Established: 1876
Revenues: $24,540 (+10%)
Earnings: $6,194 (-26%)
R&D: $6,086 (+9%)
TOP SELLING DRUGS
Lilly’s notable achievements this past year include the recent Emergency Use Authorization from the FDA for both bamlanivimab and baricitinib for the treatment of COVID-19, as well as positive results for donanemab in Alzheimer's disease, tirzepatide in type 2 diabetes, and LOXO-305 for cancer.
Key products contributing to growth for the year include Trulicity, Taltz, Emgality, Verzenio, Jardiance, Cyramza, Baqsimi, Retevmo, Olumiant and Basaglar, as well as the inclusion of $871.2 million in revenue for bamlanivimab, which partially offset declines for Cialis, Tradjenta and Forteo. Meanwhile, Humalog revenue was down 7% to $2.6 billion driven by lower prices in the U.S., partially offset by higher demand. Research and development expenses were up 9% to $6.1 billion, or 25 percent of revenue, due to approximately $450 million of development expenses for COVID-19 antibody therapies and baricitinib.
Significantly, two investments expanded Lilly’s pipeline in neurodegenerative diseases with disease-modifying therapeutics. In a transaction valued at approximately $880 million, based on the first regulatory approval, Lilly acquired Prevail Therapeutics, a biotechnology company developing potentially disease-modifying AAV9-based gene therapies for neurodegenerative diseases. Lilly gains a new modality for drug discovery and development, along with Prevail's portfolio of clinical and preclinical assets. Prevail's lead gene therapies are PR001 for Parkinson's disease with GBA1 mutations and neuronopathic Gaucher disease, and PR006 for frontotemporal dementia with GRN mutations. Preclinical assets include potential gene therapies for Alzheimer's, Parkinson's disease, amyotrophic lateral sclerosis (ALS).
Also, for $135 million upfront and as much as $1.2 billion in additional future payments, Lilly acquired Disarm Therapeutics, a biotechnology company creating a new class of disease-modifying therapeutics for axonal degeneration, a common, yet unaddressed pathology in a broad range of neurological diseases. Disarm discovered potent SARM1 inhibitors and is advancing them in preclinical development, with the goal of delivering breakthrough treatments for peripheral neuropathy and other neurological diseases such as ALS and multiple sclerosis. SARM1 protein is a central driver of axonal degeneration and Disarm's SARM1 inhibitors are designed to directly prevent the loss of axons.
R&D/COVID Efforts
After investing upwards of $8 billion in 2020 in business development, capital expenditures and R&D initiatives, Lilly achieved several development breakthroughs. Among them, Donanemab, an investigational drug for Alzheimer’s disease, demonstrated significant slowing of clinical decline in a Phase 2 study, and studies of LOXO-305 in oncology, tirzepatide in type 2 diabetes and Verzenio in early breast cancer, generated promising data.
Additionally, top seller Trulicity was approved for cardiovascular event reduction, Retevmo launched for non-small cell lung cancer and thyroid cancers, and Lyumjev rapid-acting insulin launched for diabetes. Also, new indications and line extensions were approved for Taltz, Cyramza and Olumiant, and Jardiance was submitted for heart failure for reduced ejection fraction.
Advancing efforts in the fight against COVID-19, in February, the U.S. FDA granted Emergency Use Authorization (EUA) for bamlanivimab for the treatment of mild to moderate COVID-19 in adults and children 12 years and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. Lilly subsequently developed bamlanivimab and etesevimab for administration together in order to address the potential challenge of SARS-CoV-2 variants likely to resist treatment with either monoclonal antibody used alone. Results from a Phase 3 trial showed that bamlanivimab and etesevimab together significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients by 70%, meeting the primary endpoint of the trial.
A global antibody manufacturing collaboration with Amgen aims to significantly increase the supply capacity available for Lilly's COVID-19 therapies bamlanivimab and etesevimab. Through the collaboration, the two companies will have the ability to quickly scale up production and serve more patients globally.
Additionally, Lilly is collaborating with Vir Biotechnology and GlaxoSmithKline to evaluate a combination of two COVID-19 therapies, bamlanivimab and VIR-7831, in low-risk patients with mild to moderate COVID-19.
Previously, in November, the FDA granted Emergency Use Authorization for Lilly’s Olumiant (baricitinib), a janus kinase inhibitor, to be used in combination with Gilead’s antiviral remdesivir in hospitalized adult and pediatric patients two years and older with suspected or confirmed COVID-19 who require supplemental oxygen or mechanical ventilation.
In other pipeline advances, the FDA accepted a supplemental New Drug Application for Jardiance, which is being investigated as a potential new treatment to reduce the risk of cardiovascular death and hospitalization in heart failure and to slow kidney function decline in chronic heart failure with reduced ejection fraction.
Another late stage asset, tirzepatide, achieved topline results from a Phase 3 study, which showed superior A1C and body weight reductions in adults with type 2 diabetes after 40 weeks of treatment. Tirzepatide is an investigational, once-weekly, insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single molecule, representing a new class of medicines for type 2 diabetes.
Importantly, Lilly plans to submit for authorization of its investigational antibody donanemab for Alzheimer’s under the accelerated approval pathway later this year. The FDA recently granted Breakthrough Therapy designation based on clinical evidence that donanemab targets a modified form of beta amyloid called N3pG. This follows the recent FDA approval of Biogen’s Alzheimer’s therapy Aduhelm, the first drug to receive approval for AD in nearly 20 years, which is also designed to reduce amyloid beta plaques in the brain.
Finally, new data for the investigational use of Verzenio (abemaciclib) in high risk early breast cancer showed treatment with Verzenio in combination with standard endocrine therapy (ET) decreased the risk of breast cancer recurrence by 38.6 percent compared to ET alone. Also, the addition of Verzenio to ET reduced the risk of developing metastatic disease by 39%. Two Phase 3 trials are planned in 2021.
Alliances
Among Lilly’s early stage efforts, several alliances in rare disease, pain, cancer and immunology leverage proprietary development platforms. A research collaboration and exclusive license agreement with Precision BioSciences leverages Precision's ARCUS genome editing platform for the research and development of potential in vivo therapies for genetic disorders, with an initial focus on Duchenne muscular dystrophy and two other undisclosed gene targets.
Lilly also entered a license agreement with Asahi Kasei Pharma, acquiring the exclusive rights to AK1780, an orally bioavailable P2X7 receptor antagonist that recently completed Phase 1 studies for the potential treatment of chronic pain conditions.
A research collaboration and exclusive license agreement with Lilly’s Loxo Oncology and Merus N.V. aims to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies, which are rapidly becoming one of the most transformative immune-modulating modalities used to treat cancer.
Additionally, a global research alliance with MiNA Therapeutics aims to develop novel drug candidates using MiNA's small activating RNA (saRNA) technology platform to research up to five targets selected by Lilly across Lilly's key therapeutic areas.
Lastly, an exclusive license agreement and strategic collaboration with Rigel Pharmaceuticals aims to co-develop and commercialize RIPK1 inhibitors for the potential treatment of immunological and neurodegenerative diseases. Lilly also gains an exclusive worldwide license to Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor for all indications, including autoimmune and inflammatory diseases.
twitter.com/lillypad
www.lilly.com
Headcount: 34,000
Year Established: 1876
Revenues: $24,540 (+10%)
Earnings: $6,194 (-26%)
R&D: $6,086 (+9%)
TOP SELLING DRUGS
| Drug | Indication | 2020 Sales | (+/-%) |
| Trulicity | diabetes | $5,068 | 23% |
| Humalog | diabetes | $2,821 | -7% |
| Alimta | cancer | $2,330 | 10% |
| Forteo | osteoporosis | $1,046 | -26% |
| Taltz | Psoriasis | $1,789 | 31% |
| Humulin | diabetes | $1,260 | -2% |
| Jardiance | diabetes | $1,154 | 22% |
| Basaglar | diabetes | $1,124 | 1% |
| Cyramza | stomach cancer | $1,033 | 12% |
| Verzenio | breast cancer | $913 | 57% |
Lilly’s notable achievements this past year include the recent Emergency Use Authorization from the FDA for both bamlanivimab and baricitinib for the treatment of COVID-19, as well as positive results for donanemab in Alzheimer's disease, tirzepatide in type 2 diabetes, and LOXO-305 for cancer.
Key products contributing to growth for the year include Trulicity, Taltz, Emgality, Verzenio, Jardiance, Cyramza, Baqsimi, Retevmo, Olumiant and Basaglar, as well as the inclusion of $871.2 million in revenue for bamlanivimab, which partially offset declines for Cialis, Tradjenta and Forteo. Meanwhile, Humalog revenue was down 7% to $2.6 billion driven by lower prices in the U.S., partially offset by higher demand. Research and development expenses were up 9% to $6.1 billion, or 25 percent of revenue, due to approximately $450 million of development expenses for COVID-19 antibody therapies and baricitinib.
Significantly, two investments expanded Lilly’s pipeline in neurodegenerative diseases with disease-modifying therapeutics. In a transaction valued at approximately $880 million, based on the first regulatory approval, Lilly acquired Prevail Therapeutics, a biotechnology company developing potentially disease-modifying AAV9-based gene therapies for neurodegenerative diseases. Lilly gains a new modality for drug discovery and development, along with Prevail's portfolio of clinical and preclinical assets. Prevail's lead gene therapies are PR001 for Parkinson's disease with GBA1 mutations and neuronopathic Gaucher disease, and PR006 for frontotemporal dementia with GRN mutations. Preclinical assets include potential gene therapies for Alzheimer's, Parkinson's disease, amyotrophic lateral sclerosis (ALS).
Also, for $135 million upfront and as much as $1.2 billion in additional future payments, Lilly acquired Disarm Therapeutics, a biotechnology company creating a new class of disease-modifying therapeutics for axonal degeneration, a common, yet unaddressed pathology in a broad range of neurological diseases. Disarm discovered potent SARM1 inhibitors and is advancing them in preclinical development, with the goal of delivering breakthrough treatments for peripheral neuropathy and other neurological diseases such as ALS and multiple sclerosis. SARM1 protein is a central driver of axonal degeneration and Disarm's SARM1 inhibitors are designed to directly prevent the loss of axons.
R&D/COVID Efforts
After investing upwards of $8 billion in 2020 in business development, capital expenditures and R&D initiatives, Lilly achieved several development breakthroughs. Among them, Donanemab, an investigational drug for Alzheimer’s disease, demonstrated significant slowing of clinical decline in a Phase 2 study, and studies of LOXO-305 in oncology, tirzepatide in type 2 diabetes and Verzenio in early breast cancer, generated promising data.
Additionally, top seller Trulicity was approved for cardiovascular event reduction, Retevmo launched for non-small cell lung cancer and thyroid cancers, and Lyumjev rapid-acting insulin launched for diabetes. Also, new indications and line extensions were approved for Taltz, Cyramza and Olumiant, and Jardiance was submitted for heart failure for reduced ejection fraction.
Advancing efforts in the fight against COVID-19, in February, the U.S. FDA granted Emergency Use Authorization (EUA) for bamlanivimab for the treatment of mild to moderate COVID-19 in adults and children 12 years and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. Lilly subsequently developed bamlanivimab and etesevimab for administration together in order to address the potential challenge of SARS-CoV-2 variants likely to resist treatment with either monoclonal antibody used alone. Results from a Phase 3 trial showed that bamlanivimab and etesevimab together significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients by 70%, meeting the primary endpoint of the trial.
A global antibody manufacturing collaboration with Amgen aims to significantly increase the supply capacity available for Lilly's COVID-19 therapies bamlanivimab and etesevimab. Through the collaboration, the two companies will have the ability to quickly scale up production and serve more patients globally.
Additionally, Lilly is collaborating with Vir Biotechnology and GlaxoSmithKline to evaluate a combination of two COVID-19 therapies, bamlanivimab and VIR-7831, in low-risk patients with mild to moderate COVID-19.
Previously, in November, the FDA granted Emergency Use Authorization for Lilly’s Olumiant (baricitinib), a janus kinase inhibitor, to be used in combination with Gilead’s antiviral remdesivir in hospitalized adult and pediatric patients two years and older with suspected or confirmed COVID-19 who require supplemental oxygen or mechanical ventilation.
In other pipeline advances, the FDA accepted a supplemental New Drug Application for Jardiance, which is being investigated as a potential new treatment to reduce the risk of cardiovascular death and hospitalization in heart failure and to slow kidney function decline in chronic heart failure with reduced ejection fraction.
Another late stage asset, tirzepatide, achieved topline results from a Phase 3 study, which showed superior A1C and body weight reductions in adults with type 2 diabetes after 40 weeks of treatment. Tirzepatide is an investigational, once-weekly, insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single molecule, representing a new class of medicines for type 2 diabetes.
Importantly, Lilly plans to submit for authorization of its investigational antibody donanemab for Alzheimer’s under the accelerated approval pathway later this year. The FDA recently granted Breakthrough Therapy designation based on clinical evidence that donanemab targets a modified form of beta amyloid called N3pG. This follows the recent FDA approval of Biogen’s Alzheimer’s therapy Aduhelm, the first drug to receive approval for AD in nearly 20 years, which is also designed to reduce amyloid beta plaques in the brain.
Finally, new data for the investigational use of Verzenio (abemaciclib) in high risk early breast cancer showed treatment with Verzenio in combination with standard endocrine therapy (ET) decreased the risk of breast cancer recurrence by 38.6 percent compared to ET alone. Also, the addition of Verzenio to ET reduced the risk of developing metastatic disease by 39%. Two Phase 3 trials are planned in 2021.
Alliances
Among Lilly’s early stage efforts, several alliances in rare disease, pain, cancer and immunology leverage proprietary development platforms. A research collaboration and exclusive license agreement with Precision BioSciences leverages Precision's ARCUS genome editing platform for the research and development of potential in vivo therapies for genetic disorders, with an initial focus on Duchenne muscular dystrophy and two other undisclosed gene targets.
Lilly also entered a license agreement with Asahi Kasei Pharma, acquiring the exclusive rights to AK1780, an orally bioavailable P2X7 receptor antagonist that recently completed Phase 1 studies for the potential treatment of chronic pain conditions.
A research collaboration and exclusive license agreement with Lilly’s Loxo Oncology and Merus N.V. aims to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies, which are rapidly becoming one of the most transformative immune-modulating modalities used to treat cancer.
Additionally, a global research alliance with MiNA Therapeutics aims to develop novel drug candidates using MiNA's small activating RNA (saRNA) technology platform to research up to five targets selected by Lilly across Lilly's key therapeutic areas.
Lastly, an exclusive license agreement and strategic collaboration with Rigel Pharmaceuticals aims to co-develop and commercialize RIPK1 inhibitors for the potential treatment of immunological and neurodegenerative diseases. Lilly also gains an exclusive worldwide license to Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor for all indications, including autoimmune and inflammatory diseases.
