[Transfer] Biotech Life and death, 43%of enterprises are not as expected to sell

[Transfer] American Biotech Life and Death: 43%of the company's sales are not as good as the truth behind expectations

Source: amino observation/Cai Jiu

Over the past few years, Biotech densely ushered in the moment of proved himself.

According to the statistics of ZS Associates, from 2019 to 2021, only 36 Biotech, which launched commercial products for the first time, has increased significantly.

Among them, there are many successful stories. Among the 30 companies that can be counted, 43%of the company's product sales have achieved exceeding expected performance (more than 120%of the analysts expected).

Of course, failure is also the normal state of BIOTECH, and 43%of the company performs lower than expected (80%of the analysts expect from analysts). Among them, the product sales of nine companies were even lower than 50%of the expected expectations, and the worst was only 24%of the expected.

When domestic innovative drugs have gone through the early stage of research and development, they gradually entered the stage of commercialization. This is another "life and death" of Biotech.

The truth of BIOTECH in the United States is obviously worthy of our attention. So why is BIOTECH commercialization so difficult? The reason is roughly divided into the following 5 points:

The market competition is fierce, and the differentiated or image advantages of new products are limited; poor compliance requires long -term and inconvenient administration or treatment; there are too many elements of product use, such as a series of steps to be completed to finally use the medicine; commercial propaganda publicity; commercial propaganda Inadequate, lack of sufficient publicity and being restricted by the new crown epidemic; the price is too high, although the product can benefit patients clinically, but the price has hindered.

/ 01 /

The market competition is fierce, and Biotech, which is not dominant

For a long time, commercialization has been a short board of BIOTECH. This can be seen through the commercial performance of different types of pharmaceutical companies. According to the Research Report of Xingye Securities, the peak income of listed products listed in large pharmaceutical companies is 50%higher than small pharmaceutical companies.

In other words, it is not easy for Biotech to stand out when the product is not significantly different. This is also the core reason for the commercial loss of BIOTECH in the United States.

Taking the HER2 monoclonal antibody Margetuximab of Macrogenics Biopharmaceuticals as an example. At the end of 2020, the product was approved by the FDA and was used to treat adult metastatic HER2 positive breast cancer patients who had received two or more anti -HER2 targeted therapy.

HER2 targets have achieved heavy bombs and other heavy bombs such as Herceptin, and now the hot DS8201. But Margetuximab has a poor commercialization. In 2021, Macrogenics revenue received only $ 12.3 million.

The reason is not difficult to understand. For HER2 targets, the breast cancer market has always been a place for soldiers. Strong hands are like clouds, Margetuximab products have no significant advantages, and there are security issues (with 2 black frame warnings), which eventually leads to its sales Fer than expected.

Today, Macrogenics has abandoned Margetuximab's follow -up clinical, and has developed other pipelines. This also tells us that in the homogeneous competition market, Biotech must take out the eye -catching products in order to stand out.

The same is true of the domestic market. Take HER 2 targets, for example, the ADC track has poured into many players such as Hengrui Pharmaceutical, Bai Outai, Rongchang Biology, New Code Biology, and Correnbo Tai, let alone other fields. In the future, product data will be the key to testing these pharmaceutical companies.

/ 02 /

The second of commercialization is the second, poor compliance

In a fiercely competitive market, Biotech is not easy to commercialize. So, what if it is in the field of no competitors?

The answer is that this is not easy. Sage is the best example.

In June 2019, Sage's Zulresso was approved for listing by FDA. This is the first postpartum depression treatment drug approved by the FDA. According to SAGE's forecast, there are more than 500,000 target groups that need to be treated in the United States.

It is expected to be beautiful enough, but the sales figure of Lengbing gives SAGE. In 2020, Zulresso's sales were only $ 6.7 million, and fell to $ 6.3 million in 2021.

This number only reaches 24%of analysts. As a result, Zulresso has become the most failed product of BIOTECH in the past few years.

So, what causes Zulresso to "defeat" in the field without opponents? The core reason is that product compliance is not high. Zulresso is extremely inconvenient and requires a disposable vein for 60 hours.

In this treatment, patients may need to be calm or suddenly lose their consciousness, and medical institutions need to take care of them. This also leads to the unwilling to open a Zulresso prescription whether it is a patient or a medical institution.

In addition, Zulresso is also limited by multiple factors such as high price and small insurance coverage, which eventually leads to its commercialization far less than market expectations.

/ 03 /

The third commercial blocking Land Rover, there are too many elements of product use restrictions

For a drug, it is particularly critical whether it can be simply prescribed. The core product of RHYTHM Pharmaceutical Imcivree is a failed case. In November 2020, IMCIVREE was approved to go public for the treatment of genetic obesity.

According to RHYTHM pharmaceutical predictions, the United States may have 100,000 to 200,000 patients responding to IMCIVREE. Although the scale of the patient's group is not too large, it is enough to achieve a Biotech.

The market is also expected to not be low. It is expected that the first annual sales of the product will exceed 10 million US dollars. It is for this reason that after IMCIVREE was approved, the stock price of RHYTHM pharmaceuticals continued to rise, with a market value of more than 2 billion US dollars.

But IMCIVREE disappointed the market. In 2021, IMCIVREE's sales were only $ 3.154 million. Why is the commercialization of imcivree so bleak?

On the one hand, it is because patients who were scarce restricted market demand; on the other hand, they lacked simultaneous use with diagnostic products.

IMCIVREE's obesity caused by POMC, PCSK1 or LEPR defects. This means that if obese patients want to use the drug, they need to first pass the genetic test to confirm whether they are appropriate.

However, the diagnosis requires strict clinical certification to be approved to be listed. The RHYTHM Pharmaceutical's accompanying diagnostic products for the product did not be approved simultaneously, which eventually led to the restriction of IMCIVREE.

This is also worth learning from domestic pharmaceutical companies. After all, in the current general trend of precision medical care, the research and development of targeted drugs will be the main direction. Including domestic pharmaceutical companies such as Baiji Shenzhou, Cinda Bio, Yasheng Pharmaceutical, Beida Pharmaceutical, Gakos, Deqi Pharmaceutical, Nuo Chengjianhua, etc. In the future, the core pipelines are mainly targeted drugs.

How to develop drugs while developing drugs is undoubtedly a matter of thinking.

/ 04 /

Commercial marketing, whether the relationship of related products can be sold

The channel ability of pharmaceutical companies is undoubtedly the key to product volume. But channels are not completed one day, which is also the reason why the big pharmaceuticals are strong, and Biotech is in a weakness at the commercial level.

How to let more doctors accept their own products in the shortest time, it is also related to the success or failure of commercialization. In this regard, Trevena is a negative textbook.

In August 2020, Olinvyk's Olinvyk was approved by the FDA for the treatment of acute pain that requires intravenous injection opioid analgesics and insufficient treatment.

As an opioid drug, although Olinvyk is facing fierce market competition, it also has its own unique features: fast results, among which the starting time is 1-3 minutes. To this end, the domestic Enhua Pharmaceuticals obtained the commercialization of Olinvyk's domestic region through the introduction method.

However, although the product has unique advantages, Olinvyk's sales are terrible. From the official delivery in 2021 to the end of the year, the annual sales of only $ 498,000. That's right, the sales of less than $ 500,000 a year.

Why does this happen? Market speculation is affected by two factors. First, opioid control is becoming more and more stringent; second, marketing is not in place.

In this regard, Trevena stated that because of the impact of the epidemic, it was difficult to meet with medical providers, pharmacists or other participating prescriptions and prescription decisions, which eventually caused poor sales.

Not only Olinvyk. The TG -treated PI3KΔ / CK1ε inhibitor Ukoniq also encountered the same situation. Although UKONIQ is the first oral medicine in similar products and has compliance advantages, sales only reached 74%of analyst expectations.

The market believes that there are two factors that are not as commercialized by Ukoniq. One is that the cost of medication is higher than the existing drugs; the other is that compared with competitors, marketing experience and resources are lacking.

This also wakes up the domestic BIOTECH, and marketing is essential for commercialization of new drugs.

/ 05 /

Price decision penetration rate, pricing is very knowledgeable

There are many reasons for determining a drug penetration. In addition to the effects and compliance factors, the price is also critical. After all, too high prices will make it difficult for some people to pay, and ultimately make it less commercially as expected.

Nulibry developed by Origin Biosciences encountered this situation. NULIBRY is a product for treating type A molybdenum auxiliary factor deficiency.

Type A molybdenum auxiliary factor deficiency is an alternative hidden genetic disease caused by the synthesis of molybdenum auxiliary factor synthesis. It is extremely rare. Patients are usually infants with severe encephalopathy and refractory epilepsy, with higher mortality rates.

Before Nulibry was launched in February 2021, type A molybdenum auxiliary factor deficiency was not rescued. However, as an epoch -making product, Nulibry is commercialized, and sales are only 34%of market expectations.

The reason is two points. First, the target group is too niche. Analysts predict that there may be only 150 patients in the United States every year.

Second, product pricing is high. The product is priced at more than $ 500,000. For pharmaceutical companies, because the patients are small, they need higher pricing to cover R & D expenses, but the price is obviously inappropriate, which may greatly hinder patients' use. Obviously, the pricing issues are worthy of attention, both at home or abroad. In China, the current CAR-T therapy, dual-resistant and other products are facing this situation.

Due to too high prices, the commercialization of CAR-T therapy for companies such as Yaoming Juuo has progressed slowly. Of course, this is also caused by the high preparation cost of CAR-T therapy itself. But anyway, "pricing" is a knowledge that requires pharmaceutical companies.

/ 06 /

Summarize

In fact, the success of a new drug commercialization depends on many variables. Through analysis, we can probably get some key factors.

Through the above examples, it is not difficult to find that these variables run through the early commercialization strategies and execution of the early development of BIOTECH.

It is said that failure is the mother of success. The experience of the failure of these US stocks BIOTECH is undoubtedly worthy of our reference. Full ~ ""

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