Bio-Thera (688177): Adalimumab continues to grow BAT8006 enter phase III clinical trials
DATE:  Apr 11 2025

Event: On April 9, 2025, the company released its 2024 annual report: the annual operating income was 743 million yuan, a year-on-year increase of 5.44%, mainly due to the continuous growth of adalimumab sales; R&D expenses were 778 million yuan, a year-on-year increase of 1.17%; The selling expense ratio was 31.71%, a year-on-year increase of 7.73%.

Adalimumab continued to grow, and tocilizumab added overseas business.

In terms of products, the self-exempt business continued to grow steadily, while the revenue of the oncology business declined.

Autoimmune drugs: In 2024, the sales revenue will be 602 million yuan, a year-on-year increase of 22.83%, and the gross profit margin will be 78.63%, mainly due to the continuous growth of adalimumab sales, and the company's self-operated team has reached cooperation with more than 1,500 domestic prescription hospitals and more than 1,500 pharmacies. At the same time, tocilizumab has added overseas supply business, but overseas partners are still in the early stage of expansion, with relatively small increases and relatively low gross profits.

Anti-tumor drugs: In 2024, the sales revenue will be 133 million yuan, a year-on-year decrease of 36.29%, and the gross profit margin will be 26.09%, mainly due to the decrease in licensing revenue of anti-tumor drugs with higher gross profit margins, resulting in a decrease in the overall gross profit margin of anti-tumor drugs.

A number of varieties have been licensed to further expand the overseas market

Tocilizumab (BAT1806): In April 2021, the Company licensed the development and commercialization of BAT1806 in global markets other than China to Biogen; In April 2025, Organon acquired exclusive commercial rights to BAT1806 intravenous dosage form in the U.S. market, and on the same date, the company regained full global rights to develop, manufacture and commercialize the subcutaneous dosage form of BAT1806 (tocilizumab) and the full global rights to the intravenous dosage form of BAT1806 (tocilizumab) outside the U.S. from Biogen.

Bevacizumab (BAT1706): The Company has licensed the rights to BAT1706 products in China to BeiGene for a fee; In the United States, Europe, Canada and most other BAT1706 international markets not covered by the partnership, the commercialization rights are licensed to Sandoz for a fee; Signed a licensing and commercialization agreement with Biomm in the Brazilian market; Signed licensing and commercialization agreements with Cipla in selected emerging countries; Signed a licensing and commercialization agreement with Mega Lifesciences in the Indonesian market; Signed licensing and commercialization agreements with Macter for the Pakistani and Afghan markets.

Golimumab (BAT2506), ustekinumab (BAT2206), secukinumab (BAT2306) and mepolizumab (BAT2606): The Company signed licensing and commercialization agreements with Pharmapark for BAT2506, BAT2206 and BAT2306 in the Russian and other CIS markets; Signed a licensing and commercialization agreement with Hikma for the U.S. market in BAT2206; Signed a licensing license and commercialization agreement with Biomm for the Brazilian market for BAT2206; The Company signed licensing and commercialization agreements with SteinCares for BAT2506, BAT2306 and BAT2606 in Brazil and the rest of Latin America. Licensing and commercialization agreement with STADA Arzneimittel for BAT2506 in the European Union, the United Kingdom, Switzerland and certain other European countries; Signed licensing and commercialization agreements with Gedeon Richter for BAT2206 in the EU, UK, Switzerland and other markets; Signed a licensing and commercialization agreement with Tabuk for BAT2206 in the Saudi Arabian market; Signed a licensing and commercialization agreement with Intas for BAT2506 in the U.S. market; Signed a licensing and commercialization agreement with World Medicine for BAT2206 in the Turkish market; With Dr. Reddy's Laboratories has signed licensing and commercialization agreements with BAT2506 in BAT2206 and other markets in Cambodia, Indonesia, Malaysia, the Philippines, Thailand, and other markets, and Dr. Reddy's will also have exclusive commercialization rights BAT2206 the Colombian market.

Five products are in pivotal clinical stages, BAT8006 initiating phase III clinical trials for ovarian cancer.

Five of the Company's products BAT1308, BAT3306, BAT5906, BAT4406F and BAT8006 are in Phase III clinical studies or pivotal registration clinical studies, of which BAT5906 have completed the enrollment of subjects in the Phase III clinical trial of wAMD.

The company has developed an ADC drug targeting FRα BAT8006 and is preparing to initiate a Phase III clinical study (CTR20251345) of single-agent comparator chemotherapy in patients with platinum-resistant advanced ovarian cancer, primary peritoneal cancer and fallopian tube cancer, with the primary clinical endpoint being PFS.

Profit forecast and investment rating: We expect that the company's operating income in 2025/2026/2027 will be 8.89/13.42/1.790 billion yuan, with a year-on-year growth rate of 19.59%/50.97%/33.40% respectively; The net profit attributable to the parent company was -4.15/-1.07/172 million yuan, with a year-on-year growth rate of 18.76%/74.18%/260.81% respectively. Maintain "Buy" rating.

Risk warning: The progress of overseas authorization and approval is less than expected, the sales capacity of overseas partners is less than expected, and the risk of failure of clinical trials of new drugs.

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