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YUSHI Pharmaceutical
Is the controversial "Luye Pharma" still worth starting?
Time: 2021-08-18
[China Pharmaceutical Network Enterprise News] After Luye Pharma’s report was released, the controversy was relatively serious. Although I wrote some opinions briefly, I still feel that I haven't written a deeper perspective. Moreover, Luye has become the target of my full position in Hong Kong stocks (there are only a handful of single full positions in the investment history of ten years), so let's open an article to talk about my views that are different from the market.
I am not very confident about the pharmaceutical stocks. Although I can barely count as a messenger in the pharmaceutical industry, I think I know more about OTC drugs. I don’t know much about the prescription drugs in the main hospitals, so please forgive me for any mistakes. The current worries of the market are mainly aimed at two points. First, Lipu Su will be replaced. Second, doubts about Luye's research and development. Let me add that the value of green leaves is not worth buying, and when to buy it.
一, will Lipusu be replaced?
Lipusu’s biggest threats are mainly two points, how will it go after the medical insurance negotiation fails, and how will it go after the domestic albumin paclitaxel comes out. As for the disagreement after the failure of the medical insurance negotiation, there should not be much dispute. According to experts, management conference calls, and provinces that have come out (Hubei Province), it is highly probable that the provinces (nine provinces) that have been added to the list will remain in the list, and they have not been added. The probability of entering is not great. That is to say, the impact of existing provinces is limited, and the impact of potential incremental provinces is greater. But for Lipusu to continue to maintain growth, it only needs to increase marketing efforts to increase the proportion of self-paying people, and the stock market itself will grow naturally. Simply put, the impact of the failure of the medical insurance negotiations will not cause a bad situation.
Let's talk about the influence of domestic albumin paclitaxel. "Under popularization, the difference between my understanding of the paclitaxel drug market and the market is that I divide paclitaxel varieties into four mainstream varieties, version 1.0 ordinary paclitaxel injection, version 2.0 docetaxel, and version 3.0 paclitaxel liposome (Lipusu ), version 4.0 albumin paclitaxel. The reason is their essential structure (paclitaxel), and the indications are basically the same. Although the actual clinical is still slightly different."
Let's look at the threat of domestic albumin paclitaxel. Analysis of this problem should be divided into two questions. One is how strong the impact is. The second is how soon the impact will come. Many investors may have a kind of linear thinking, no matter what kind of medicine, as long as it is an upgraded version, it will always completely replace the old version. But for the pharmaceutical industry, this understanding is obviously an intuitive error. There are many cases in the pharmaceutical industry. After more than ten years of development, the old drug market is still larger than the new drug market. Drugs are to be replaced quickly. From a logical point of view, there are only the following points. The medical theory has undergone a complete innovation, there are great pain points or a very reliable proof of efficacy (in accordance with the premise of cost-effectiveness). Otherwise, this drug substitution is destined to be slow and orderly. In fact, the same is true. There is no clinical data to prove that there is a statistical difference between albumin paclitaxel and ordinary paclitaxel. It is more about pain points (adverse reactions), which is not much different from Lipusu.
With this understanding, I know that it is difficult for new drugs to replace old drugs explosively when the price difference is large enough. Looking at the two sets of data again, from the domestic market growth rate (which can be counted as competitiveness), albumin paclitaxel>; Lipusu>; docetaxel>; ordinary paclitaxel. According to the domestic market sales data collected by IMS, from 2011 to 2015, the average annual growth rate was 32.68%, 25.91%, 4.5%, and -3.73% respectively. From the perspective of market sales scale, they are 315 million, 1.509 billion, 2.792 billion, and 1.228 billion. From the perspective of growth rate, the gap between Lipusu and albumin paclitaxel is not large, and it is more like a joint force replacing docetaxel and ordinary paclitaxel in the market. In terms of the size of the stock market, docetaxel and ordinary paclitaxel still have a space of 4 billion. If they are gradually converted into the more expensive treatments of Lipusu and albumin paclitaxel, the stock market will at least double. If we look at the long-term view, an aging society is coming, and the cancer incremental market itself is expected to at least double its capacity. If there is still a big cake in the short to medium term, it will definitely not let Lipusu and albumin paclitaxel fall into a desperate competition. It is even more likely that Lipusu will continue to sink to replace the market for docetaxel and ordinary paclitaxel, while albumin paclitaxel will slowly eat up the first-tier hospital market. There is still a certain degree of misalignment between the two. Based on the above data, I don't think there will be a big impact in two to three years. The first to be impacted is to start with the least competitive varieties. But if the domestically produced albumin paclitaxel is stubbornly similar to Lipusu (pricing, market entry), what should we do? Let's not talk about whether the competitive product can be industrialized and the cost of human blood.
I still believe in some of my experience: as a billion-dollar product with the largest market share, it has more than ten years of safe use experience and history, and the confidence and habits of doctors in using drugs, including the roots of drug generation in the local market. For many years, the unclear relationship with local government affairs and local hospital doctors is not something that can be replaced as a new product. The process of entanglement and anti-entanglement will be quite long. If you have really done this, you may have some experience.
Second, what is the research and development of Luye?
Luye’s R&D or M&A direction or the idea of ??making products are all my favorites. The direction of research and development must be right. Cardiovascular and cerebrovascular, diabetes, cancer, and central nervous system are all major diseases, and they will be the major diseases with the highest growth rate in the future. If the direction of the main channel is right, it is half right. Moreover, the implementation is also good. One field is more than one billion, and the remaining three fields are over 500 million. Once such a system is completed, it will help the follow-up products (whether acquired or self-developed). Great.
Let’s take a look at Luye’s follow-up R&D pipelines, risperidone, rotigotine, exenatide, and goserelin, closely following the four major disease areas. The general direction is completely fine. Let's look at the idea of ??making products again. The current three main products are mainly Lipusu, Acarbose, Xuezhikang, and Rivastigmine. The common thinking of several varieties is that they don’t take the usual path. Except for Xuezhikang, the other processes are extremely difficult. Lipusu is liposome. Check the drug Zhinet. In fact, there are several companies that develop paclitaxel liposomes. I have received clinical approvals for a long time, but I have been belching in the past few years. There are discussions that the industrialization is too difficult and I gave up.
Acarbose is also bio-fermented, with many impurities, so few can make it. Just looking at Luye’s vision of Acarbose, it can be said to be quite vicious. First of all, Acarbose is the largest variety of oral medicines in China, and the market structure is good, only three. The process is difficult, preventing the entry of subsequent competitors, and the life is quite moist. Moreover, Luye’s sales system is also quite good. Although the varieties are good, it is also extremely difficult to grab food from the two giants. However, facts have proved that Luye’s market share has been rising year after year by restructuring the sales of Sichuan Baoguang. According to the current sales growth rate, and medical insurance enters a category.
I personally think that it is not difficult to exceed 500 million and reach 1 billion within three to five years, and it will become a new engine for driving the overall business. Before the mid-term report of Acarbose, I thought it would exceed expectations, because I am extremely optimistic about this variety. It is the first choice for long-term oral medications for diabetic patients in China. The price is high and the barriers are good.
The barriers to the transdermal field of kabaratin are not to be mentioned. Xuezhikang used to be a medical insurance policy, pricing issues, coupled with channel reforms, policy issues, etc., turbulence for a year or two. However, the effects of these problems are being eliminated at present, and a certain degree of growth will be restored in the future. I am still confident. I am not confident enough to be able to do more. If the Chinese patent medicine for cardiovascular and cerebrovascular diseases is to be big, it must be made into a panacea. Only the "health products" promoted by such multi-disciplinary departments will become the blockbuster. Although Xuezhikang has some characteristics, such as natural lipid-lowering, FDA clinical, etc., but after reading the indications, dosage and pricing strategy, I feel that there are still deficiencies. It may also be my experience bias. On the whole, Luye’s current framework is that the existing products and R&D directions are right, with a certain level of competitiveness and channel power, and the varieties of R&D and M&A have the basis of high barriers.
Let’s talk about microspheres again. Luye’s microsphere technology content is the highest in the country. This is not disputed. Livzon Qilu’s is a copy, and its time effect is worse than Luye’s. Another is the FDA's Phase II and Phase III clinical approval (it is also leading internationally), and the other is the domestic approval, which shows the strength of Luye's microspheres. At present, there are not many domestic players in this field, and Luye has been doing it for more than ten years, slowly figuring out the craftsmanship and the doorway. If the microspheres come out at the end of 2017 as expected, Luye Pharma will never get out of such a K-line chart. Some big V think that the crux of the stock price is Lipusu, and spent a long time discussing Lipusu, but the real heart disease of the market should be the research and development process. The microball cannot be released, because the long-term logic has not been determined. Whoever comes out depends on Lipusu. But the microspheres didn't come out, so the stock price should be low if the stock price is low. Anyway, the stock price of Hong Kong stocks is mostly low. For the stock price to rise, the market must be greedy. Microspheres are definitely the most greedy fruit in the market.
According to IMS predictions, four years after the release of risperidone microspheres, optimism can get 200 million dollars, and goserelin can get 160 million dollars. Rotigotin can get 500 million dollars in 2025. It's not a problem to take exenatide for a hundred million dollars. This does not include the follow-up microsphere product line. "Roughly expected" these four varieties together can double and double the size of the enterprise. Even according to the most pessimistic prediction, it is difficult to open the market abroad, but through the introduction of new drugs abroad, the new regulations that can be directly marketed in China can be sold domestically. If you learn from Livzon's microsphere varieties, you can sell a lot of money. One injection every two weeks and one injection a month. What kind of good news is it for patients with chronic diseases? How can investors who are not sick experience it?
In short, from the perspective of R&D strategy, chronic disease management, micro-innovation, a steady stream of new microsphere products (505B2), high-barrier gameplay, are in line with investors’ appetites, but why the market does not appreciate it and gives negative estimates Value (Invest nearly 200 million of profits every year for research and development). The reason is that the time to market is expected to be one and a half years later. Yes, just because it is one and a half years late, the market's attitude can turn 360 degrees. One and a half years can change the views of many investors, is it difficult to give birth? Such questions are filled with the minds of small groups and institutions. The main difficulties are patent lawsuits, large-scale industrialization of product stability issues, and CGMP certification.
But according to the information I collected, and thank you for the information provided by Brother Ba, the large-scale industrialization problem has been solved, the plant has been invested, and there will be no problems. Johnson & Johnson's patent lawsuit conference call has been answered, and the lawsuit will be won in the second half of the year. I am currently waiting for FDA acceptance. The recruitment website I searched is also looking for talents in this area. The problem should be stuck in the certification. The company is also right to do it slowly, and it must strive for a one-time pass. I don't know how much the market will value after the first microsphere product is launched. At least I may not be willing to increase the position by 20 times before it comes out, but I may be willing to increase the position by 25 times the valuation after it comes out.
How likely is the listing application to be OUT? I have read an FDA data, but I forgot about it. It's probably less than 5%. So our high probability of losing is only time. I like Luye's acquisition or its own R&D pipeline. Some investors look down on acquisitions and prefer to buy more R&D, but this is actually purely prejudiced, or there is a common R&D complex among Chinese people. Under actual national conditions, the positive correlation between actual R&D and profitability of domestic pharmaceutical companies has always been questionable. The R&D of several large-scale pharmaceutical companies is not decent, but with a few magical drugs, it has a market value of 30 or 40 billion. Instead, those who really engage in research and development pay the price of shareholders’ blood.
For example, the Hisun Pharmaceutical (12.33 +1.90%, diagnosis stock) that I invested before (not derogatory). Although the subsequent policy development is definitely more related to R&D, it cannot be ignored that management and sales are a very important part at all times. Looking at the above, it can be seen that Luye’s mergers and acquisitions are quite good, and the acquired varieties are also good varieties. There is really no need to worry about questioning Luye’s development stamina. The current market value and R&D pipeline are enough to double the size of Luye. Besides, major international pharmaceutical companies are also peers in R&D and M&A. In recent years, M&A has to spend more money than R&D. The main reason is that it is more difficult to find new compounds. The R&D achievements of small biotech companies are used to graft brands and channels. It may be more efficient from a business perspective.
三, is the current green leaves worth buying?
To answer this question, let me add a passage from Brother Moutai 03, whom I respect and trust. "When you ask what you buy when investing, I can tell you that what you buy is the odds, not the R&D, brand, and management. These are the words of scholars. We are investors, cost-effectiveness, return on investment and risk evaluation. That’s the key, and R&D, branding, and management are just factors that increase the odds.” I think the words written by Livzon Group (50.07 +1.62%, diagnostic stocks), which Brother Moutai once invested in, are quite useful for reference. .
At the beginning of this article, I talked about the fundamental risks faced. If I agree with my views, I know that the risks are completely controllable. I have seen quite a few pharmaceutical companies recently. If a pharmaceutical company is serious about picking the bones, it doesn’t say that it can’t fault it. It is possible that there is nothing wrong with Hengrui Pharmaceuticals (58.38 +0.41%, diagnostic stocks), China National Biopharmaceuticals, and CSPC. But are they really okay? Or everyone didn’t even look at the fundamentals seriously when the stock price rose. Even if it’s really okay, is such an odds structure suitable for us to place heavy bets?
On the other hand, Luye has a net profit of nearly one billion at present, and has been struggling for a year or two. When the microspheres come out, isn’t it the stone medicine of four or five years ago? (Enbipu phenomenon) What is buying Luye? Regardless of valuation, Luye’s current management thinking and capabilities, channel power in four major disease areas, several existing heavy moats and unique R&D pipelines and process R&D barriers are quasi-first-line drugs. The potential of a company, even if it is not directed at a low valuation, is also worth buying. What's more, it can be bought for 10 billion at the moment.
10 billion is put on A-share pharmaceutical companies, and most of the pharmaceutical companies that can be bought have various serious problems. And the one billion profit volume, put A shares at least 30 to 40 billion. In the premise of Luye Hong Kong Stock Connect, there is still such a severe valuation difference, to be honest, I really don't understand. No wonder you want to return to the embrace of Big A.
When to buy?
If you look at my point of view, this question is actually very simple. The safe point of intervention or the one you don’t want to be tortured is to buy the microspheres after implementation. And if you want to eat the whole fish, the odds are bigger, or there is no other investment target, you can buy it now. The main point of view regarding the mid-line buying point during this period is: The performance of the interim report is viewed from the growth rate of operating income. First-line pharmaceutical companies such as Pharmaceutical Group and Huadong Pharmaceutical (48.35 +2.59%, diagnostic stocks) are all very impressive performances.
Among them, the core product, Lipusu, is generally expected to have an increase of more than 15% in the first half of the year (the IMS terminal statistics increase by 20% from January to May), but the actual company-level growth is only 5%, so the market thinks that it is not as expected, but the facts Shanglipusu has indeed achieved a 20% increase in terminal sales. The reason for the gap is mainly due to the fact that the channel believes that there will be a price reduction after entering the medical insurance negotiations, which will cause delays in the purchase. In addition, the simple production capacity of the Nanjing factory is also restricted (grass roots).
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