Lilly Reports Strong 2020 Financial Results Driven by Trulicity Amid Declining Linagliptin Sales

On January 29, 2021, Eli Lilly announced its 2020 financial results. The company’s total annual revenue reached $24.5 billion, a 10% year-over-year increase. The diabetes segment, contributing $11.8 billion, remained the key performance driver for Eli Lilly. Among its products, Trulicity (dulaglutide) achieved sales of $5.068 billion in 2020, representing a 23% year-over-year growth, making it the best-selling long-acting GLP-1 analog globally. Jardiance (empagliflozin) and its combination formulations surpassed $1 billion in global sales, continuing their rapid growth trajectory. In contrast, Basaglar experienced a significant slowdown in growth, while the global market for linagliptin began to contract. Within the autoimmune portfolio, Taltuzumab (note: likely referring to Taltz/ixekizumab) generated $1.788 billion in sales, a 31% increase, and baricitinib reached $638 million, up 50%. In oncology, the CDK4/6 inhibitor saw a substantial 57% surge, reaching $912 million in sales.

Notably, in the special year of 2020, Eli Lilly’s bamlanivimab and baricitinib both received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the treatment of patients with novel coronavirus disease; among these, the combination regimen of bamlanivimab and etesevimab continues to report updated clinical benefit data, warranting close attention.

Lilly

https://investor.lilly.com/static-files/c03e912c-c3fd-49b4-b383-fb0debe5b2f3

In brief, key points worth noting in Eli Lilly's 2020 financial report:

1. Diabetes care contributed 48% of Eli Lilly’s performance, with Trulicity standing out as a key driver; its sales exceeded $5 billion in 2020, representing a year-on-year increase of 23%. Despite strong competition from semaglutide, it maintained healthy growth. Meanwhile, tirzepatide, Eli Lilly’s next-generation blockbuster for diabetes and weight management, achieved a milestone, with highly positive results from the first Phase 3 clinical trial, SURPASS-1.

2. In the diabetes business, Eli Lilly’s empagliflozin and its combination formulations achieved sales exceeding $1 billion for the first time, representing a 22% increase, thereby becoming the best-selling SGLT-2 inhibitor globally. It is anticipated that sales will continue to grow with the expansion of its indications in heart failure.

3. In the diabetes business, the performance of Basaglar, a biosimilar of insulin glargine, slowed down rapidly, with sales remaining at $1.1 billion in 2020;

4. In the autoimmune portfolio, Taltz is an emerging star, carving out a niche among a constellation of next-generation products including ustekinumab, secukinumab, and guselkumab; its sales continued to grow by 31% in 2020. Baricitinib maintained robust growth of 50%, with ongoing expansion into atopic dermatitis and alopecia areata indications. Notably, the marketing application for atopic dermatitis has been submitted, laying a solid foundation for future healthy growth.

5. Among oncology products, the CDK4/6 inhibitor abemaciclib achieved a milestone, demonstrating significant clinical benefit in combination with endocrine therapy for patients with early-stage HR+/HER2- breast cancer. The monarchE trial propelled it to prominence, making its 2021 performance particularly anticipated.

6. In the field of neurodegenerative diseases, Eli Lilly is a pioneer; in 2020, it successively acquired Disarm Therapeutics and Prevail to strengthen its central nervous system portfolio. Meanwhile, donanemab has also made positive progress, with Phase 2 clinical data demonstrating benefits for patients with early-stage Alzheimer’s disease.

7. Novel coronavirus: During the 2020 global COVID-19 pandemic, multiple regimens of bamlanivimab and baricitinib received Emergency Use Authorization, contributing to the treatment of COVID-19.

Trulicity: Semaglutide is growing rapidly and will pose a threat to dulaglutide in the future

In 2020, Eli Lilly’s annual sales exceeded $5 billion, maintaining healthy and rapid growth. However, it is worth noting that semaglutide is also experiencing rapid growth. According to Novo Nordisk’s Q3 2020 financial report, semaglutide’s quarterly sales reached DKK 5.4 billion (approximately $864 million). Cumulative sales for the first nine months of 2020 amounted to DKK 15 billion (nearly $2.4 billion), with full-year 2020 sales projected to be around $3.5 billion. Meanwhile, semaglutide is under development for indications in obesity and non-alcoholic steatohepatitis (NASH).

Dulaglutide: The World's Best-Selling Long-Acting GLP-1 Analog

Lilly

https://investor.lilly.com/static-files/a5dbe9fa-f45f-41ef-bc16-bc12be6dd606

Empagliflozin: The World’s Best-Selling SGLT-2 Inhibitor

Lilly

https://investor.lilly.com/static-files/a5dbe9fa-f45f-41ef-bc16-bc12be6dd606

Diabetes: Eli Lilly Develops Next-Generation Products to Further Solidify Its Position in the Field

Accounting for half of the revenue, diabetes is undoubtedly Eli Lilly’s most pivotal therapeutic area. The company is currently making all-out efforts to advance tirzepatide, a next-generation dual GIP/GLP-1 receptor agonist that has demonstrated significant potential in the treatment of type 2 diabetes, weight management, and non-alcoholic fatty liver disease (NAFLD).

2020 Major Advances in Tirzepatide: HbA1c -2.07% vs. +0.04%

Tirzepatide garnered significant attention upon the release of its Phase 2 data, and the SURPASS-1 trial results have further confirmed its superior efficacy in glycemic control and weight reduction. Currently, Eli Lilly has initiated multiple large-scale Phase 3 clinical trials covering indications for diabetes, obesity, and NASH, making the progress of tirzepatide worthy of long-term attention.

Lilly

https://investor.lilly.com/static-files/a5dbe9fa-f45f-41ef-bc16-bc12be6dd606

Lilly

https://investor.lilly.com/static-files/c03e912c-c3fd-49b4-b383-fb0debe5b2f3

Seeking the Next Topz: Eli Lilly Invests $2.5 Billion to Further Boost Autoimmune Commitment

Taltz has defeated adalimumab (SPIRIT-H2H), ustekinumab (IXORA-S), and guselkumab (IXORA-R) in head-to-head trials; however, the IL-23 monoclonal antibody mirikizumab is progressing slowly, with limited market expectations in the future.

Lilly

https://investor.lilly.com/static-files/c03e912c-c3fd-49b4-b383-fb0debe5b2f3

In 2020, Eli Lilly continued to invest in its early-stage autoimmune assets, including the $1.1 billion acquisition of Dermira; on March 31, 2020, it entered into a five-year collaborative development agreement for metabolic immunotherapy projects worth $880 million; and in March 2019, it reached a three-year collaboration agreement on metabolic immunotherapy valued at $605 million.

Eli Lilly’s Two Project Collaborations in Metabolic Immunotherapy

Oncology Portfolio: The Next-Generation CDK4/6 Inhibitor Abemaciclib Is Rapidly Gaining Momentum

Within Eli Lilly’s oncology portfolio, pemetrexed and ramucirumab are two blockbuster products. Among next-generation offerings, the CDK4/6 inhibitor is experiencing rapid growth; in addition to swift global regulatory approvals, expansion into indications such as adjuvant therapy for early-stage breast cancer remains a key focus. In September 2020, abemaciclib achieved a milestone: data from the monarchE trial demonstrated that abemaciclib combined with endocrine therapy yielded significantly greater clinical benefit than endocrine therapy alone in patients with early-stage HR+/HER2− breast cancer, with 2-year invasive disease-free survival (IDFS) rates of 92.2% versus 88.7%. In contrast, palbociclib has failed in the same indication, while data for ribociclib have not yet been disclosed.

https://investor.lilly.com/static-files/0bce715a-15eb-4eaf-8e20-9576e76b63b1

Abemaciclib vs. Palbociclib vs. Ribociclib: Abemaciclib Offers Differentiated Advantages

It is anticipated that abemaciclib will be the first CDK4/6 inhibitor to successfully expand into the adjuvant treatment of early-stage breast cancer. In terms of dosing regimen and survival benefits, abemaciclib demonstrates differentiated advantages over palbociclib or ribociclib currently on the market. The future prospects for abemaciclib are highly promising!!!

https://investor.lilly.com/static-files/0bce715a-15eb-4eaf-8e20-9576e76b63b1

https://investor.lilly.com/static-files/c03e912c-c3fd-49b4-b383-fb0debe5b2f3

Eli Lilly Deepens Its Focus on Neurodegenerative Diseases: Donanemab Shows Positive Progress

On January 11, 2021, Eli Lilly announced clinical progress for donanemab. Data from the TRAILBLAZER-ALZ trial demonstrated that donanemab significantly improved cognitive function and activities of daily living in patients with early-stage Alzheimer’s disease, with a 32% relative reduction in scores on the Integrated Alzheimer's Disease Rating Scale (iADRS), indicating clinical benefit. In 2020, Eli Lilly continued to strengthen its presence in the central nervous system (CNS) therapeutic area, acquiring Disarm Therapeutics and Prevail Therapeutics, thereby adding gene therapy pipelines for amyotrophic lateral sclerosis (ALS)/multiple sclerosis (MS) and neurodegenerative diseases to its portfolio.

Due to space constraints, detailed updates on Eli Lilly’s progress with third-generation BTK inhibitors and novel coronavirus treatments are omitted. Here are a few of the most anticipated developments for Eli Lilly in 2021:

1. Progress of LOXO-305 in Non-Hodgkin Lymphoma;

2. Progress of Baricitinib in Alopecia Areata and Systemic Lupus Erythematosus;

3. Progress of tirzepatide data from SURPASS-2/3/4/5, with an anticipated submission for marketing approval;

4. Significant anticipation for the oncology business, specifically the submission of a marketing application for an adjuvant therapy regimen for early-stage breast cancer to regulatory authorities;

5. Sintilimab: U.S. Marketing Application Submitted for Non-Small Cell Lung Cancer;

6. Finally, it is hoped that Eli Lilly’s cocktail therapy will bring more hope to the treatment of COVID-19.

https://investor.lilly.com/static-files/635ce8ea-cd6b-4e3f-aca6-d53eb52c20cf

Eli Lilly's Key Product Sales (in million USD)