Incident: On June 24, Hanyu Pharmaceutical announced that the marketing application for liraglutide injection submitted jointly by the company and Hikma PharmaceuticalsUSA, Inc. to the FDA has obtained provisional approval from the US FDA.
Comment: The company's liraglutide injection has received provisional approval from the FDA, indicating that the product has completed all the review requirements for generic drugs, that is, the quality, safety, and efficacy of the drug has met the standards for marketing in the US. This means that once the original Liraglutide patent expires, the product is expected to be fully approved. This approval proves that the company's quality in the field of peptide drugs has been verified by international reviews and has officially opened up the US market space for GLP-1 drugs.
1. The pace at which the company lays out products overseas is accelerating, and commercialization of liraglutide biosimilar drugs overseas is imminent.
Up to now, Hanyu Pharmaceutical has successfully passed the US FDA's cGMP standard on-site inspection from the API production base to the formulation production base, and has continuously received multiple overseas commercial orders for GLP-1 APIs and formulations. This time, liraglutide injection adopted an external licensing cooperation model. In addition to the front-end transaction price, it also enjoyed back-end profit sharing. According to Novo Nordisk's annual report, due to the trend in production capacity of simeglutide, Liraglutide (hypoglycemic version Victoza and Saxenda weight loss version) had sales of US$1,618 billion, US$1,508 million and US$969 million respectively in the US in 2021-2023. Since the complete patent for liraglutide developed in the US has not yet expired, no similar drug has been approved for marketing. Once Hanyu Pharmaceutical's liraglutide injection is officially approved for marketing by the FDA, it is expected to become the first batch of liraglutide generic drugs in the US. Assuming that the price of similar drugs is reduced by 30% after approval and can account for about 20% of the market share, we estimate that the peak sales of the company's liraglutide analogues is expected to reach US$135 million after official approval in the US.
2. Liraglutide preparations were exported to the United States for the first time, marking that Hanyu Pharmaceutical's international peptide preparations have ushered in a new stage of development. This approval proves that the high quality of the company's international pipeline's production, R&D, and process has been approved by the FDA. In addition to liraglutide, subsequent multi-pound polypeptide preparations and APIs, such as simeglutide and telpotide, are expected to accelerate the overseas process. At present, the company has announced that the order for liraglutide injections has been fulfilled and sent to the US, and the company's peptide preparations have officially entered the commercial release period when going overseas.
Profit forecast: We expect the company's 2024-2026 revenue to be 10.69, 17.16, and 2.4 billion yuan respectively, with year-on-year growth rates of 147.81%, 60.52%, and 39.86%, respectively, and net profit to mother of 0.75, 2.64, and 561 million yuan, respectively. The year-on-year growth rates are 114.52%, 253.28%, and 112.72%, respectively, maintaining the “Highly Recommended” rating.
Risk warning: competition increases risk, risk of product sales falling short of expectations, policy risk.