Eli Lilly Reports 18% Revenue Growth Driven by Strong Pipeline Ahead of 2022 Drug Launches

Compiled and translated | Fan Dongdong

According to the latest financial data from Eli Lilly, driven by four of its top-selling products, the company's revenue increased by 18% during the July to September period this year compared to the same period last year. The data shows that revenues for the diabetes medication Trulicity (dulaglutide), immunology blockbuster Taltz (ixekizumab), breast cancer treatment Verzenio (abemaciclib), and migraine prophylaxis antibody Emgality (galcanezumab-gnlm) all grew by more than 30% year-on-year.

Eli Lilly's global revenue reached $6.77 billion in the third quarter of 2021, of which global revenue from COVID-19 treatments amounted to $423.5 million. Excluding COVID-19 treatment revenue, the company's revenue for the third quarter and year-to-date grew by 11%. Non-GAAP earnings per share also rose to $1.94, up 38% year-over-year, but slightly below Wall Street's prior expectation of $1.96 per share.

Regarding this, Eli Lilly Chairman and Chief Executive Officer David Ricks stated that the company once again delivered strong performance this quarter. Revenue growth driven by new medicines exceeded 35%, accounting for nearly 60% of core business, which is also a key indicator of Eli Lilly's long-term growth potential. Ricks also highlighted the numerous positive developments in the company's pipeline, as well as the successful expansion of Verzenio and Jardiance into new indication markets.

In August this year, Jardiance, co-developed by Eli Lilly and Boehringer Ingelheim, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with heart failure with reduced ejection fraction (HFrEF), with or without type 2 diabetes. In October, the U.S. FDA approved an expanded indication for Eli Lilly’s CDK4/6 inhibitor Verzenio (abemaciclib), for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) as adjuvant treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence.

In addition to breakthroughs achieved by existing products in new indications, Eli Lilly’s new drug development is also expected to secure regulatory approval in 2022. First, Eli Lilly has initiated a rolling submission to the U.S. FDA, seeking accelerated approval for donanemab in the treatment of early Alzheimer’s disease. Previously, the U.S. FDA granted donanemab, an Alzheimer’s drug, Breakthrough Therapy designation. If approved in the future, donanemab will compete with Biogen’s Aduhelm (aducanumab). Although Aduhelm received FDA approval earlier this year, its post-approval progress has been notably slow due to ongoing external scrutiny and controversy surrounding the drug. Eli Lilly is currently conducting the Phase 3 TRAILBLAZER-ALZ4 head-to-head clinical trial, which aims to compare the efficacy of donanemab and Aduhelm in clearing brain amyloid plaques in patients with early symptomatic Alzheimer’s disease.

Eli Lilly's second drug expected to receive regulatory approval next year is the novel diabetes medication tirzepatide. Just this week, Eli Lilly announced that it has submitted a New Drug Application (NDA) for tirzepatide to both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA submission package was accompanied by a Priority Review Voucher, which is expected to accelerate the regulatory review process for tirzepatide. The strategic importance of this drug to Eli Lilly is evident, as it serves as another key asset for the company to maintain its market position in diabetes therapeutics following dulaglutide. Under the FDA's Priority Review program and timeline, Eli Lilly anticipates that the process from application submission to marketing approval will take approximately eight months, potentially leading to tirzepatide's approval by the end of June 2022.

Upon final approval, both drugs are set to become key market launches for Eli Lilly in 2022, poised to further drive the company's financial performance. Cantor Fitzgerald analyst Louise Chen noted that, compared to its peers, the company’s earnings outlook remains highly favorable. Chen further emphasized that, backed by a robust pipeline of best-in-class assets—including donanemab and tirzepatide—Eli Lilly has “entered an earnings growth period that will extend through 2030.”

Source: Eli Lilly focuses on 2022 launches as revenues climb by 18%