In terms of selling vaccines, Zhong's answer sheet in 2023 does not seem to be very satisfactory.
Recently, Wantai Biology, a subsidiary of Zhong Sui, released an announcement on the pre-reduction of its annual results in 2023, and it is expected that the annual net profit attributable to the parent company in 2023 will be 1.2 billion to 135 billion yuan, a year-on-year decrease of 7149% to 7466% (Net profit in 2022 was 48.)6.3 billion yuan).
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Behind the high pressure on performance, it is mainly affected by the sales of bivalent HPV vaccines, Wantai Bio pointed out in the announcementIts bivalent HPV vaccine revenue decreased by about 4.2 billion yuan compared with the same period last year, and the gap was huge.
Judging from the performance of the secondary market, the share price of Wantai Biotechnology has continued to fall since the after-hours performance announcement on January 23, but since February, Wantai Bio has harvested 4 price limits, and the short-term stock price changes brought about by the performance pre-reduction have been repaired.
From the perspective of the value of its R&D pipeline, the main reason for the change in its stock price trend in the secondary market is nothing more than the recognition of the overall market value of the nine-valent HPV vaccine by funds, and the fact that Wantai Bio's nine-valent HPV vaccine is expected to become the first domestic launch.
With the sharp decline in sales of bivalent HPV vaccines, there are still uncertainties in the approval of 9-valent HPV vaccines, and Wantai Biotech has stood at the crossroads of the times.
Zhong's bivalent HPV vaccine,
Near dusk
Since the listing of Wantai Biotechnology and Nongfu Spring in 2020, Zhong's personal wealth has been unbeatable, leading the way and becoming the richest man for three consecutive years.
Although from the perspective of the company's market value, Nongfu Spring is many times that of Wantai Biotech, but the market value of Wantai Biotech of nearly 100 billion yuan is placed in the domestic biomedical track, which is really a behemoth.
Wantai Bio's product types are divided into several categories, such as diagnostic reagents, vaccines, diagnostic instruments, ** products, and active raw materials, among which the vaccine sector is the core of revenue, accounting for more than 80% according to the 2023 semi-annual report. In the vaccine sector, Wantai Biotech holds hepatitis E vaccine, bivalent HPV vaccine and nasal spray new crown vaccineBivalent HPV vaccines account for the vast majority of revenue.
The horizontal market of bivalent HPV vaccine in China presents a three-legged posture. GSK's Cervarix was first listed in the EU in 2007 and launched in China in 2016, and is suitable for women aged 9-45. Wantai Biotech's Cecolin, launched in 2020, is the first domestic HPV vaccine, suitable for women aged 9-45 years; Walvax Biotech's Wozehui will enter the market in 2022 and is suitable for women aged 9-30.
The approval of the bivalent HPV vaccine Cecolin has ushered in explosive growth in Wantai's revenue and profit. From 2020 to 2022, Wantai's revenue growth rate will be %, and its revenue will increase from 235.4 billion in one fell swoop, an increase to 111 in 20228.5 billion, three-year revenue increased by 5 times. The growth rate of net profit far exceeded the growth rate of revenue, respectively, from 6. % of net profit in 20207.7 billion to 47 in 20223.6 billion, a 7-fold increase in profits.
From the revenue growth rate and net profit growth rate, it is not difficult to find that the rapid growth of Cinkonin cecolin in 2022 has declinedWhen Wantai Biotech announced its financial report for the first quarter of 2023, the weak sales of Cecolin were visible at a glance, and the subsequent semi-annual and quarterly reports continued the downward trend.
Behind the changes that Cecolin has experienced are two major factorsThe first is the first-class fight between the bivalent HPV vaccine on the track, and the second is the dimensionality reduction of the nine-valent HPV vaccine.
On the first point, although Walvax Biotech's Wozehui, which was approved in 2022, has a disadvantage in terms of applicable age, it has taken advantage of Cinconin Cecolin.
According to public information, in the public procurement of HPV in many places across the country in 2022, the bidding price of Wozehui is about 245 yuan, while the Cinkronin Cecolin at that time still maintains 329 yuan.
In 2023, Cinkolin Cecolin has also been affected by sales and has reduced its price. In August 2023, the bidding results of the bivalent HPV vaccine announced by Guangdong Province showed that the final Cinclonin cecolin won the bid with 116 yuan, a significant decrease.
Judging by the issuance batch,In the first half of 2023, a total of 230 batches of Bivalent HPV vaccine were approved and issued (+55.).41%), while a total of 313 batches (+9%) were approved for issuance in the whole of 2023, with a significant decline in the second half of the year, which is enough to reflect that after the price reduction, Cinkolin Cecolin is still under huge sales pressure.
After the price reduction, Cinkolin cecolin will not achieve price for volume in 2023 and return to growth.
The battle in the horizontal market of bivalent HPV vaccine is certainly a major reason, but the dimensionality reduction of the nine-valent HPV vaccine and the compression of the market space of the bivalent HPV vaccine are the biggest reasons for its weak sales.
As we all know, the higher the "price" of the HPV vaccine, the more types of HPV virus subtypes that can be prevented, and the higher the protection rate.
In China, only one 9-valent HPV vaccine has been approved. Merck Gardasil9 was approved in 2018 and is suitable for women aged 16-26 years.
And also in 2022, in August, Merck & Co., Ltd. gardasil9 achieved a population expansion, and the applicable age was broadened from 16-26 years old to 9-45 years old, which also meansThe crowd advantage of Cecolin is gone, and only the best advantage and production capacity advantage remain.
In terms of production capacity, the production capacity of the bivalent HPV vaccine laid out by Wantai Bio is 30 million per year, and the sales volume in 2022 will be about 27 million, with sufficient production capacity. The nine-valent HPV vaccine needs to be obtained through "lottery", "number grabbing", "distribution", etc.
The demand is passed on, and the rapid growth of bivalent HPV vaccine is also reasonable.
From 2017 to 2020, it took Merck four years to nearly double the global HPV vaccine volume**, and from 2020 to 2023, Merck will continue to increase investment in production capacity.
The increase in production capacity has also contributed to the rapid growth of issuance, and many ** have reported in the second half of 2023 that the nine-valent HPV vaccine is no longer "hard to find".
As for **, perhaps from the underlying logic of the product, it is not a real advantage. For more women who choose to receive the bivalent HPV vaccine, the bivalent HPV vaccine is used as an alternative to the 9-valent HPV vaccine, and perhaps it can also be said to be a transitional product.
Moreover,Merck & Co., Ltd. Gardasil9 has also recently been approved for a 2-dose vaccination schedule (women aged 9-14 years), which compresses the advantages of bivalent HPV vaccine in disguise.
When the 9-valent HPV vaccine is no longer "hard to find", how many women will choose to receive the low-cost vaccine?
Zhong's bivalent HPV vaccine is in jeopardy.
The 9-valent HPV vaccine to be marketed,
Wobbly
As mentioned above, at present, only Merck's Gardasil9, a nine-valent HPV vaccine, is on the market in China.
Merck's 2023 financial report showsgardasil9's revenue in 2023 reached $8.9 billion, up 33% year-over-year (excluding foreign exchange effects), mainly due to strong demand in China.
At present, the penetration rate of gardasil9 is still insufficient, and the market space waiting to be fed is huge.
A domestic nine-valent HPV vaccine in the third phase of clinical trial, **Sullivan.
At present, there are 5 HPV vaccines in the third phase of clinical trials in China, namelyWantai Biotech, Kangle Guard, Recco Biotech, Watson Biotech and Bowei Biotech, and Wantai Biotech's products seem to be expected to be the first to hit the line.
From December 7 to 18, 2023, Wantai Biotech has ignited the market with two news, one is that the company's nine-valent HPV vaccine production workshop is undergoing commercial-scale production process verification, and the other is that the on-site work of the phase V8 visit of the main clinical trial of the nine-valent HPV vaccine has been completed, which seems to mean that the clinical research of the nine-valent HPV vaccine has entered the final stage.
In addition, under the guidance of the "Clinical Technical Guidelines for Human Papillomavirus Vaccine (Draft for Comments)", Wantai Biotech, which holds the marketed bivalent HPV vaccine, is expected to accelerate the listing of the 9-valent HPV vaccine under development as an iterative vaccine, and it is expected that Wantai Bio's 9-valent HPV vaccine will submit a BLA application in 2024.
From the perspective of R&D, it is still unknown whether Wantai Bio's nine-valent HPV vaccine can really be approved as expected by the market and break the import monopoly again.
And if it goes public,In the hand-to-hand combat with Zhifei Biotech on the sales side, how much market share can Wantai Bio grab? In the first-class battle that had to break out after the approval of a number of HPV vaccines in the follow-up, can Wantai Biotech gain a firm foothold? The real market value of Wantai Bio's nine-valent HPV vaccine still needs real market verification to give a specific answer.
In addition, there is one more point worth noting. In the 2023 performance forecast, Wantai Biotech said that "the company's asset impairment items related to the new crown vaccine, such as R&D investment, special raw materials and finished products, and special production equipment, will affect the company's overall profit decline by more than 400 million yuan".
The asset impairment mentioned here may continue to amplify in 2024 at the bivalent HPV production line.
At present, the production capacity of bivalent HPV vaccine laid out by Wantai Biotech is 30 million per year, and the sales volume in 2022 will be about 27 million, with overcapacity, and the bivalent HPV vaccine market is expected to be in the impairment channel in 2024, and the overcapacity will continue to increase.
So, can the production capacity of Wantai's bivalent HPV vaccine be used for the 9-valent HPV vaccine? The answer is no. Wantai Biotech has said that "it is temporarily impossible to use the bivalent HPV vaccine production line for the production of nine-valent HPV vaccine".
The 9-valent HPV vaccine needs new production capacity to support it, and the bivalent HPV vaccine production line is expected to bring significant impairment. On the eve of the approval of the nine-valent HPV vaccine, Wantai Bio's revenue and net profit seem to be more impacted.
summary
Summary
The pattern of the domestic HPV vaccine market is being reshaped.
GSK's bivalent HPV vaccine has been withdrawn from the market in the United States under the impact of the nine-valent HPV vaccine. On the other hand, in China, Merck's 9-valent HPV vaccine production capacity has been gradually released, and the market size of the bivalent HPV vaccine has declined sharply.
Wantai Bio, whether it can return to high-speed growth, looking at the pipeline of Wantai Bio, it seems that we can only see the performance of the nine-valent HPV vaccine.
Looking forward to the post-9-valent HPV vaccine era, will the more advanced one be a better solution? Probably not.