Summary:
1. In the first half of the year, the company achieved sales revenue of 210 million yuan, an increase of 18.9% over the previous month, and a gross profit of 164 million yuan, an increase of 20.5% over the previous month. Of this total, overseas sales recorded 14 million yuan, an increase of 150.9 percent over the same period last year. VenusP-Valve, the first domestic transcatheter pulmonary valve replacement (TPVR) system registered and listed in Europe this year, has been sold for only two months, with a sales revenue of 9 million yuan, reflecting the great potential of overseas commerce.
two。 The competition pattern changed little in the first half of the year, 63% in the first half and 67-68% at the end of last year, because Medtronic approved it at the end of last year and started sales in the first half of last year. Peijia also started at the end of Q2 last year. Excluding these two new products, the original pattern of the company has not changed much. The company focuses on hospitals with an average volume of 15-20 operations per year but with very high potential. If 4000 units are completed in the whole year, it will be about 58% of the market share, and the whole market should be 7000 units.
3. With regard to the lung valve, the company says it is a completely innovative device, the first in China, which is expected to reach dozens to 100 this year, and may climb to hundreds of surgeries next year. In the future, the number of surgeries in China and Europe may be 2500 / a, and the global competition for pulmonary valves is very good. Besides Edward and Medtronic, the company is the third. It will also continue to apply for FDA, and clinical studies are expected to start in the United States and Japan next year.
Qroomamppac A:
Q: recently, National Healthcare Security Administration gave an answer to Jicai, leaving room for innovative medical devices. how to interpret it?
This is not a direct policy, but a reply to the National people's Congress, but it is very important. The Health Insurance Bureau is responsible for
Price is the main direction, for those with relatively large usage, full competition, little clinical difference and high occupation of health insurance.
The price of the product should be reduced to benefit the people and reduce the burden of medical insurance. Short-term market sentiment is pessimistic. Before the 20th CPC National Congress
National Healthcare Security Administration has a clear reply, I am not surprised from the expression, the state clarifies that it is hoped that the local medical insurance bureau
There are scientific considerations when promoting.
Q: what is the number of operations in July and August?
There was some replenishment in July because of the closure of the epidemic, about 350 to 400 units. August is a little less than July, and the compensation effect is weakened. August-September is a holiday and an off-season. There were 300 units in July and August last year.
Q: what do you think of the competition?
The pattern did not change much in the first half of the year. We had 63% in the first half and 67-68% at the end of last year because Medtronic was
Approved at the end of last year, sales began in the first half of the year, and Peijia also started at the end of Q2 last year. Excluding these two new products, our original pattern has not changed much. We also gave up about 100 high-priced operations in the first half of the year. We have done the admission of these hospitals, but we will not pursue this market. We will focus on hospitals with an average volume of 15-20 operations per year but with very high potential. If we complete 4000 units in the whole year, which is about 58% of the market share, the whole market should be 7000 units, and our market share will not change much next year.
Q: sales expectation of lung valve + brain protector
In China, we were officially approved in July, mostly using our European clinical results, and it is also the first time that domestic and foreign data have been applied to innovative devices at the same time. In the future, we will also adopt this strategy to form a national multi-center to study and declare at the same time. We made our debut in China a few days ago, and we also performed the first three surgeries. The lung valve is completely innovative in China and is the first product. This year, it is estimated that in dozens to 100 days, the number of surgeries may climb to hundreds next year. In the future, the number of surgeries in China and Europe may be 2500 / a. The global competition for pulmonary valves is very good. Apart from Edward and Medtronic, we are the third. Edward and Medtronic are both ball expansion methods. Medtronic products have been seriously recalled this year, and we have also received approval for 2 humanitarian surgeries. We will continue to apply for FDA in the future, and clinical studies are expected to start in the United States and Japan next year.
Q: the prospect of the growth rate of mitral valve replacement
With the inclusion of health insurance in Shanghai this year, several other provinces and cities are also considering it. They should rush into local doctors quickly next year and the year after next.
The stage of insurance. In the field of high-value consumables, mitral valve replacement is the most representative, and health insurance also has significant support.
If so, the average annual CAGR will still return to 50% for two or three years, and then the price will slowly fall. We do not pursue simple quantity in the short term, but high quality and profitable quantity.
Q:ASP
In the first half of the year, the terminal of the first generation product is 18-200000, the ex-factory price is 100000, and the second-generation ex-factory price is 109000-120000, corresponding to 22-240000 terminal price. The proportion of second-generation products will increase throughout the year, so the annual ASP will be more than 110000. Our second-generation products represented by Apro and Alpus will continue to rise.
With regard to the service life of Q:TMVR surgery, what level is it possible for the next generation of products to achieve?
Overseas we see some indications that 5-8 years is the average valve lifespan. We have done more than 100 An of our existing products, have 7 years of follow-up data, and only 1 case has had a reoperation, so less than 1% of the patients have valve failure. So we think the life of the material is still good, which may be more than 8 years on average. Middle valve surgery will be performed after the end of life, there is no problem. Our third-generation products are now seeking to double their lifespan. Our two new products will be clinically promoted by Q4 this year and start multicenter clinical trials in China and Europe next year.
Q: the timeline of new mitral valve products
Early feasibility studies are currently being carried out in Europe and the United States and will be followed up in China from October to November. We strive for clarity.
Clinical opening in Europe and China in 2000 is expected to be approved in 2026, and the United States will be later in 2027.
Q: pricing and sales model of lung valve
Overseas our ex-factory price is 15000 US dollars, and the terminal price is 2.4-25000 US dollars. Most of Europe is a dealer model, and there are also small direct sales teams. From the point of view of distribution, after deducting market fees, the profit margin is 25-30%.
It is obviously higher than at home, so we will expand the overseas registration of VenusP to 53 countries next year.
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