Interface News Reporter | Chen Yang
On September 12th, Lilly, which holds a star product in the GLP-1 field, announced an investment of $1.8 billion to expand production again. This time, its expansion plan is not limited to hypoglycemic and weight reducing drugs such as tilpotide, but also involves newly approved Alzheimer's disease (AD) drugs.
Specifically, Lilly's new investment involves two production facilities in Ireland. One of them is to invest $1 billion to expand the manufacturing plant in Limerick to increase the production of bioactive ingredients (APIs), including the AD drug Donanemab (trade name: Kisunla).
This drug was approved in July 2024 and is the second FDA approved drug to slow down the progression of Alzheimer's disease, following the similar new drug Lecanemab (trade name: Leqembi) from Bojian/Eisai.
This new model increases Lilly's total investment in Limerick to $2 billion. Previously, Lilly announced the establishment of a factory in Limerick in 2022, with construction starting in March 2023 and an additional investment of $500 million. Lilly stated that this expansion will create 150 job positions, increasing the number of employees in the area to 450. The API production at this location is expected to begin in 2026.
The second is to invest 800 million US dollars to expand the factory located in Kinsel, which has been producing tilpotide since 2023.
In fact, since 2020, Eli Lilly has announced investments of over $20 billion to expand production, including building and acquiring factories in the United States, Ireland, Germany, and other locations.
In May 2024, Eli Lilly announced an additional $5.3 billion to expand its production capacity in Lebanon, Indiana, USA, for the production of Tilpotide API. This brings Lilly's total investment in the park to $9 billion, making it the largest investment in synthetic drug API manufacturing in the United States.
Lilly had expected to increase the production of enteropancreatin drugs by at least 1.5 times in the second half of 2024 compared to the first half of 2023.
The huge demand for production capacity is mainly directed towards tilpotide. This drug is the world's first and only approved GIPR/GLP-1R dual target agonist. Compared to single target products such as Novo Nordisk's semaglutide, its hypoglycemic and weight reducing effects are better, and it is also considered the biggest competitor of semaglutide.
In May 2022 and November 2023, Tilpodide's indications for type 2 diabetes and weight loss were approved by the FDA, and its trade names were Mounjaro and Zepbound respectively. One month after its opening, Zepbound achieved sales of 175.8 million dollars.
In the whole year of 2023, the sales revenue of Tilpotide reached 5.339 billion US dollars, which was 6.658 billion US dollars in H1 2024. As a result, Lilly has raised its total revenue forecast for 2024 by $3 billion, expected to be between $45.4 billion and $46.6 billion.
During the same period, the sales of semaglutide in 2023 and H1 2024 were $21.157 billion and $12.9 billion, respectively, which are expected to challenge the global pharmaceutical king in 2024. However, the industry generally believes that the sales of the weight reducing version of Simeglutide Wegovy in Q2 2024 fell short of expectations, with year-on-year growth rates of 107% and 74% in Q1 and H1, respectively.
At the same time, Novo Nordisk is also continuously increasing production capacity, including the acquisition of CDMO (Contract Development Production Services) leader Catalent for $16.5 billion in February 2024.
It is worth noting that by the beginning of August 2024, on the FDA website, with the exception of low-dose Wegovy, various specifications of Tilpolotide and Smeglutide injections in the two indications of type 2 diabetes and weight loss will no longer be listed as "scarce", but "available".
At present, both tepaglutide and semaglutide are expanding their indications and seeking larger markets, including major indications such as preserved ejection fraction heart failure (HFpEF) and non-alcoholic fatty liver disease (NASH).
Among them, in April and August 2024, Lilly successively released positive data from phase III clinical studies of tilboptin in obstructive sleep apnea (OSA) and HFpEF. At present, the company has submitted an application to the FDA for the use of tilpotide in the treatment of moderate to severe OSA in obese patients, and will submit an indication application for HFpEF later in 2024.
Simeglutide also achieved the primary endpoint in clinical phase III targeting HFpEF. But previously, Novo Nordisk withdrew the application for the drug on HFpEF and stated that it would postpone the application until 2025. In addition, semaglutide has advanced in NASH and chronic kidney disease (CKD) compared to teriparatide, and the former is in clinical phase III in both indications and Alzheimer's disease.