Towards the end of the year, the domestic HPV vaccine market is still in constant news.
On December 19, Wantai Biotech had a 10% intraday limit; Another vaccine leader, Zhifei Biotech, fell more than 5% in intraday trading. As of the same day**, Zhifei Biotech reported 5881 yuan shares, down 326%。On the news side, some investors believe that the stock price fluctuation is related to the progress of the nine-valent HPV vaccine progress trial disclosed by Wantai Biotech on the investor platform some time ago.
At present, the domestic nine-valent HPV market is still monopolized by Zhifei's exclusive Merck Sharp & Dohme vaccine, and now the phase clinical trial of Wantai Bio's nine-valent HPV vaccine is nearing the end, will it deter Zhifei's position? And can Zhifei break the game?
Phase 1 clinical trials are nearing completion.
In response to investors' questions on December 14, Wantai Biotech said that the on-site work of the V8 phase of the main clinical trial of the company's nine-valent HPV vaccine has been completed, and specimen testing is underway. According to the previously disclosed protocol design, V8 of the phase III main clinical trial of Wantai Biotech's nine-valent HPV vaccine was visited once every six months, and V9-V12 was visited every 12 months.
In addition, Wantai Bio's 9-valent HPV vaccine, as an iterative vaccine, can be conditionally applied for marketing after 12 months of continuous infection according to the Technical Guidelines for Clinical Trials of Human Papillomavirus Vaccine (Trial). The company said that after the V8 clinical field work is fully completed and the relevant required tests are completed, the company will declare as soon as possible according to the accumulation of cases and meet the requirements of the guidelines.
The reporter of "International Financial News" contacted the ** Department of Wantai Biology to inquire about the marketing plan of the nine-valent HPV vaccine, but the other party did not reply positively. However, according to the provisions of the Drug Registration Administration, after a pharmaceutical company submits an NDA application, the Center for Drug Evaluation will conduct a comprehensive review of the safety, efficacy and quality controllability of the drug based on the drug registration application materials, verification results, and inspection results. The whole process is over, and it generally takes 2-3 years.
Although the launch time of the nine-valent HPV vaccine is still unknown, the disclosure of the above news is enough to make Wantai Bio's investors boil in the secondary market. Wantai Biotech's share price has gone from 49 on December 135 yuan, up to 57 on December 1962 yuan.
A new way out under performance pressure.
In contrast to the hot secondary market, Wantai Biotech has gradually cooled down its performance in recent years. As a domestic vaccine leader, Wantai Biotech has two popular track products, HPV and new crown pneumonia, and its operating income once increased from 118.4 billion yuan rose to 111 in 2022900 million yuan, achieving a growth of more than 8%. From 2019 to 2022, the net profit attributable to the parent company of Wantai Biotech will be 20.9 billion yuan, 67.7 billion yuan, 202.1 billion yuan, 473.6 billion yuan.
In recent years, some provinces and cities have included bivalent HPV vaccines in centralized procurement, and the dividends of the new crown epidemic have faded, the revenue growth of Wantai Bio's two core products has collectively stalled.
Specifically, Wantai Biotech's bivalent HPV vaccine has long lost its dominant position, and Walvax Biotech's Wozehui is sharing the bidding market with it, and the final result can only be the one with the lowest price. At the end of July, Guangdong Province released the bidding results of the publicly-funded bivalent HPV vaccine as an example, Wantai Bio's Xinkonin won the bid with 116 yuan, compared with 329 yuan at its own expense, a decrease of 647%, only about one-third of the out-of-pocket expenses**. In addition, after the expansion of Merck's 9-valent vaccine, the advantage of bivalent HPV vaccine in age coverage has also been lost.
In terms of new crown vaccines, based on the comprehensive judgment of the changes in China's epidemic prevention policy and the future income of the nasal spray new crown vaccine project, Wantai Bio's R&D expenditure on the new crown vaccine that has been capitalized in 2022 and will occur in the future will be fully expensed in 2022 and 2023.
Therefore, in the latest three quarterly reports, Wantai Bio's revenue and net profit both fell sharply. In the first three quarters of this year, Wantai Biotech achieved revenue of 496.9 billion yuan, a year-on-year decrease of 4256%；Net profit attributable to the parent company 180.8 billion yuan, down 54 percent year-on-year15%。Judging from the current vaccine pipeline under development of Wantai Biotech, if the nine-valent HPV vaccine can seize the time and be listed before other domestic competitors, it may become a new performance pillar of the company.
Drafting: Tang Jingyang.
How to break the game after the status is not guaranteed.
At the same time as Wantai Biotech's daily limit, another vaccine leader, Zhifei Biotech, fell more than 5% intraday on December 19. Zhifei Biotech is the exclusive supplier of Merck's 9-valent HPV vaccine in China, and is currently the only owner of the approved 9-valent HPV vaccine in China.
Zhifei Biotech is also a beneficiary of the new crown epidemic dividend, and the company's recombinant novel coronavirus vaccine (CHO cell) (trade name: Zhikeweide) was approved for emergency use in March 2021 and conditionally listed in China in March 2022, becoming the first domestic recombinant new coronavirus protein vaccine approved.
From 2019 to 2022, the net profit attributable to the parent company of Zhifei Biotech was 236.6 billion yuan, 330.1 billion yuan, 102100 million yuan, 753.9 billion yuan. Among them, the operating income in 2022 will be 3826.4 billion yuan, a year-on-year increase of 2483%。Regarding the situation of increasing revenue but not increasing profits, Zhifei Biotechnology said that due to objective factors, the market demand and competition pattern of some of the company's products have changed greatly, and its sales have decreased significantly compared with last year.
According to the annual report data, the operating income of Zhifei's independent products will decline sharply in 2022. The operating income of its own products was 328.5 billion yuan, a year-on-year decrease of 6612%；Gross margin was 8648%, down 404%。Although the gross profit margin of ** products also decreased slightly, only 2866%, but the overall revenue increased by more than 70% to 3497.5 billion yuan, accounting for 91% of total revenue4%。
Whether it is from the perspective of vaccine issuance or performance, ** products are the revenue pillar of Zhifei Biotech. The age expansion of Merck's nine-valent HPV vaccine has enabled Zhifei Biotech to achieve 57 orders in the first half of this year85% growth. But this also made Zhifei Biotech fall into controversy for a while, and was accused of "lying and earning" by virtue of its ** business. Now that Wantai Biotech's 9-valent HPV vaccine has completed the critical stage of phase clinical trials, Zhifei's monopoly in the 9-valent HPV market is about to be broken, and the secondary market is naturally declining.
Zhifei Biotech is also seeking new performance growth points. The company first announced in October this year that it had reached a cooperation with GSK to become the exclusive importer and distributor of the latter's recombinant shingles in China (excluding Hong Kong, Macao and Taiwan). In the next 3 years, the minimum annual purchase amount for each of the parties is 34400 million yuan, 68800 million yuan and 103200 million yuan. In addition, Zhifei will also become the exclusive development and commercialization partner of GSK's RSV (respiratory syncytial virus) vaccine for the elderly.
The company announced on November 23 that it intends to acquire 100% of the shares of Chen'an Biotechnology held by Zhirui Investment and Zhang Gaoxia in cash and sign an equity acquisition intention agreement. After the completion of the acquisition, Chenan Biotech will become a wholly-owned subsidiary of Zhifei Biotech. Zhifei's business territory has been extended to cover metabolic diseases such as diabetes and obesity, and has expanded into the field of first-class biopharmaceuticals with Chen'an Biotech as the main body.
However, it is worth noting that Chen'an Biotech is an enterprise controlled by the actual controller of Zhifei Biotech, and the purpose of this acquisition is more to let Zhifei Biotech hitchhike on the GLP-1 concept.
In addition, according to the information disclosed by Zhifei Biotech, a total of 6 drug candidates of Chen'an Biotech have entered the clinical stage, among which recombinant liraglutide injection and insulin degludec injection have completed clinical phase III and are in the application and marketing stage; Recombinant semaglutide injection has been in the phase III clinical trial. Although the R&D stage is in the forefront of similar products in China, it still takes some time to truly land and achieve profitability.