On March 16, Henlius disclosed the 2021 performance announcement that the company achieved revenue of 1.683 billion yuan, an increase of 186.3% year-on-year. Despite the year-on-year loss reduction, the company still lost 984 million yuan. As a member of The Complex, Henlius shouted the transformation slogan of "From Biotech to Biopharma" at last year's Global R&D Day. From the current point of view, The four commercial products of Henlius are all biosimilars, and they will face the risk of biological drug collection and competitive product squeezing in the future. In 2021, Fuhong Henlin's core product HanquYou sold nearly 900 million yuan, but enterprises such as Chia Tai Tianqing, Anke Bio, and Haizheng Pharmaceutical are eyeing the tiger, and their similar products have been declared for listing.
0.95% year-on-year loss reduction
Sitting on 4 commercial products, Henlius realizes self-"hematopoiesis". According to The 2021 performance report of Henlius, the company achieved operating income of 1.683 billion yuan, an increase of 186.3% year-on-year.
At present, Henlius has 4 products listed in China, 1 product in Europe, a total of 12 indications approved, products covering tumors, autoimmune diseases, ophthalmic diseases and other fields. Its core product Hanquyou (trastuzumab, European trade name: Zercepac) contributed nearly 900 million yuan in revenue in 2021, achieving domestic sales revenue of about 868 million yuan, an increase of about 692.7% over 2020, overseas sales revenue of about 62.2 million yuan, and overseas licensing and R & D service revenue of about 30.2 million yuan.
Hanlikang, a subsidiary of Henlius, is the first biosimilar in China, and the Jiangsu Fosun team is responsible for sales promotion in China. In 2021, Henlius received sales revenue of approximately RMB542.5 million and licensing revenue of approximately RMB10.4 million based on the profit-sharing arrangement agreed with its partners.
Hendalyuan (adalimumab), approved for marketing in December 2020, is Henlius' first monoclonal antibody biopharmaceutical in the field of autoimmune diseases. Handayuan's domestic commercial sales are handled by Jiangsu Wanbang, and by the end of 2021, Henlius has received sales revenue of about 21.8 million yuan and licensing income of 1 million yuan based on the profit sharing arrangement agreed with its partners.
Henlius' fourth commercial product, Hembetil (bevacizumab), was approved by the State Drug Administration in December 2021 for the treatment of metastatic colorectal cancer and advanced, metastatic or recurrent non-small cell lung cancer. Henlius is responsible for the sales promotion of the product in China, and the revenue report does not specifically disclose the revenue of the product.
For the performance growth, Henlius said that it mainly comes from the sales revenue and licensing income brought by the commercialization of a variety of products. However, due to continuous investment in research and development, Henlius is still losing money. In 2021, Henlius lost 984 million yuan, narrowing by 0.95% year-on-year.
Moving towards Biopharma
At last year's Global R&D Day, Henlius shouted the transformation slogan "From Biotech to Biopharma". Zhang Wenjie, chairman, executive director and CEO of Henlius, said that 2021 is a year of transformation to innovation and commercialization, and that 2022 is the year of the company's upgrade from Biotech to Biopharma.
Backed by Fosun Pharma, Henlius was founded in 2010 to focus on the development of targeted monoclonal antibody drugs, including monoclonal analogues, biohades, innovative monoclonal antibodies and antibody-coupled drugs. From 2016 to 2019, Henlius lost 0.74 billion yuan, 260 million yuan, 505 million yuan and 876 million yuan respectively.
Zhang Wenjie said that Biotech and Biopharma have considerable differences, mainly in the company's size, total number of people, total revenue, number of products and so on. "Our specific understanding is that compared to Biotech, Biopharma has a relatively rich and diverse product pipeline, and these pipelines are distributed at different stages of development, such as commercialized, late, early, and have different forms and mechanisms, such as both biosimilars and bio-innovative drugs. Secondly, Biotech is a R&D-based company, and Biopharma has a relatively comprehensive and balanced organizational capability for R&D, production and commercialization. ”
Zhang Wenjie further said that Biopharma's more obvious sign is that it has a distinctive feature in terms of product sales revenue. Biopharma should be able to be very close to self-financing, that is, profitability mainly depends on itself, especially the cash flow brought by product sales revenue, so as to gradually reduce the dependence on external funds, and form an organic, healthy and benign operating state.
Competition remains
Starting with biosimilar medicines also means that Henlius will inevitably be affected by the collection. In March 2022, the Guangdong Provincial Drug Trading Center issued the "Notice of The Proposed Selection/Alternative Results of the Centralized Procurement of Diclofenac and Other Drugs of the Guangdong Alliance (The First Batch)", and rituximab was included in the collection list, and the collection of biosimilar drugs pressed the start button.
Zhang Wenjie said that biosimilars are undoubtedly a fairly important part of the company's future revenue stream. "The Guangdong Alliance collection that has just occurred is in line with our expectations, unlike small molecule drugs, the price reduction of biological drugs is relatively mild, and the impact of this ritux exe collection is relatively limited for us." In addition, the company's core product trastuzumab is the only biosimilar of trastuzumab on the market, and only when enough trastuzumab biosimilar products enter the market, it may face collection. ”
Competitors are looming. It is understood that similar products of Chia Tai Tianqing, Anke Bio and Haizheng Pharmaceutical have been reported for listing. Similar products such as Genor Bio and Qilu Pharmaceutical are also in phase III clinical development.
"The collection of biological drugs has just begun to be piloted, and before it can really land in the whole country, we still need to see further development." Zhang Wenjie believes that in addition to the price reduction range, after entering the collection, whether the production capacity of pharmaceutical companies can support the supply of collection and procurement is also a problem that needs to be considered. It is revealed that this year, Henlius is expected to have a production capacity of nearly 50,000 liters.
Henlius' PD-1 product Slullimonab is expected to be approved this year, but the current domestic PD-1 product market is already a Red Sea market after experiencing medical insurance price reductions and adaptation tests. If approved for listing, Henlius' Slullimonal antibody will become the 13th PD-1 product listed in China.
Differentiated indications and combination with other drugs are henlius' playing methods. Zhu Jun, president of Henlius, believes that "PD-1 is more than the number of approvals, but at present, in terms of the coverage of indications, there is no PD-1 approval on many subdivision indications for small cell lung and bowel cancer and stomach cancer."
Li Yan, an investor in the pharmaceutical industry, said that Henlius has made certain commercial achievements in its listed products, but in the future, it will face the pressure of biosimilar drug collection, and it may come out of the predicament by laying out overseas clinical practices in advance and exploring internationalization. (Yao Qian)