China Securities Co.Ltd(601066)
About Tinavi Medical Technologies Co.Ltd(688277)
Verification opinions on the reply to the inquiry letter of the 2021 Annual Report
Shanghai Stock Exchange:
According to the requirements of your inquiry letter on the supervision of information disclosure of Tinavi Medical Technologies Co.Ltd(688277) 2021 annual report (SSE Ke Chuang Gong Han [2022] No. 0080, hereinafter referred to as the inquiry letter), China Securities Co.Ltd(601066) (hereinafter referred to as "sponsor" or " China Securities Co.Ltd(601066) securities") as the sponsor of Tinavi Medical Technologies Co.Ltd(688277) (hereinafter referred to as "company" or " Tinavi Medical Technologies Co.Ltd(688277) "), together with listed companies and relevant intermediaries, The matters mentioned in the inquiry letter have been implemented one by one, and the answers to the questions involved in the inquiry letter are as follows:
Question 6. The annual report disclosed that since 2020, the company has explored the business model of building Siasun Robot&Automation Co.Ltd(300024) minimally invasive surgery center with medical institutions. That is, the company provides medical institutions with orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) and relevant supporting equipment required for orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) and provides technical support. Medical institutions pay the company technical service fee according to the number of Orthopaedic Surgery Siasun Robot&Automation Co.Ltd(300024) operations. Please explain: (1) up to now, under this business model, the number of cooperative medical institutions, the attributes of medical institutions, the signing of agreements, and the number of Siasun Robot&Automation Co.Ltd(300024) orthopedic operations carried out by the end of 2021 and the end of the first quarter; (2) Under this business model, the Siasun Robot&Automation Co.Ltd(300024) number of orthopedic operations invested by the company, whether there are management risks and specific countermeasures.
[reply]
1、 Up to now, under this business model, the number of cooperative medical institutions, the attributes of medical institutions, the signing of agreements, and the number of Siasun Robot&Automation Co.Ltd(300024) orthopedic operations carried out by the end of 2021 and the end of the first quarter; By the end of the first quarter of 2022, a total of 4 medical institutions have adopted the business model of building an orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) minimally invasive surgery center with medical institutions, and all have signed formal cooperation agreements, including 1 public hospital and 3 non-public hospitals.
Under this cooperation mode, by the end of 2021 and the end of the first quarter of 2022, the cumulative number of Siasun Robot&Automation Co.Ltd(300024) auxiliary orthopedic operations has been 468 and 549.
2、 Under this business model, is there any management risk in the Siasun Robot&Automation Co.Ltd(300024) number of orthopedic operations invested by the company,
Using the business model of jointly building Siasun Robot&Automation Co.Ltd(300024) minimally invasive surgery center with medical institutions, the company has launched 4 sets of Siasun Robot&Automation Co.Ltd(300024) orthopedic surgery by the end of the first quarter of 2022.
The specific cooperation mode of minimally invasive surgery center is that the company selects medical institutions with advantageous clinical experience nationwide as partners, and the company provides terminal medical institutions with relevant equipment for the construction of orthopaedic Siasun Robot&Automation Co.Ltd(300024) minimally invasive surgery center, and completes the necessary technical training. The medical institutions provide the place of minimally invasive surgery center. This mode has transformed the company's revenue structure from relying on a single one-time equipment sales revenue to the continuous sales of technical services and supporting surgical tools, realizing the diversification of revenue sources, which is conducive to the formation of a stable source of operating revenue.
In the cooperation agreement, the company's main rights and obligations are: to be responsible for providing relevant equipment of Siasun Robot&Automation Co.Ltd(300024) minimally invasive surgery center for orthopaedic surgery, providing technical training and owning the ownership of the provided equipment.
The main rights and obligations of traditional Chinese medicine institutions under the cooperation agreement are: both parties jointly build Siasun Robot&Automation Co.Ltd(300024) minimally invasive surgery center in orthopedics to provide necessary support for the construction of the project; Medical institutions obtain the right to use Siasun Robot&Automation Co.Ltd(300024) clinical technology of orthopaedic surgery in the form of purchasing technical services, and carry out clinical application, academic activities, external publicity and other activities. Under this business model, there may be the risk of property loss of the company due to poor management. For the possible management risks, the company has formulated countermeasures: the company owns the ownership of the equipment in the process of cooperation, and the cooperation agreement signed with the medical institution clearly stipulates that the medical institution has the obligation to properly manage the cooperative equipment of both parties according to the management mode of its own equipment, The loss caused by improper storage shall be borne by the medical institution. At the same time, the company realizes the collection, summary, processing and analysis of surgical data with the help of "cloud tube end" technology, which can timely find the abnormal conditions of the equipment and remotely manage the delivered equipment.
3、 Opinions of the sponsor
After verification, the sponsor believes that Tinavi Medical Technologies Co.Ltd(688277) in the business model of jointly building Siasun Robot&Automation Co.Ltd(300024) minimally invasive surgery center with medical institutions, the management methods and responsibilities of surgery Siasun Robot&Automation Co.Ltd(300024) in the process of cooperation between the two sides have been clarified by signing a contract, and countermeasures have been formulated for possible management risks, without major management risks.
The reasons for the continuous decline of performance, and give sufficient risk tips; (2) In combination with the opinions on supporting measures for centralized procurement and use of high-value medical consumables (artificial joints) organized by the state on March 30, 2022 officially issued by the national medical insurance bureau and the Health Commission, explain the impact of industrial policy changes on the company's orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) sales and the promotion of the business model of Orthopaedic Surgery Siasun Robot&Automation Co.Ltd(300024) minimally invasive surgery center jointly built with medical institutions; (3) Further explain the charging restrictions of the national centralized procurement policy on the company's relevant products or services and the potential adverse impact on the company's sustainable operation ability, and supplement and prompt the relevant risks in the annual report.
[reply]
1、 The reasons for the continuous decline of performance, and give sufficient risk tips;
The company's performance decreased year-on-year in the first quarter of 2022, mainly because the epidemic situation in China in the first quarter of 2022 was still not optimistic, the prevention and control measures were further compacted, the company's marketing activities were limited, and the procurement bidding of the company's main product orthopedic surgery Siasun Robot&Automation Co.Ltd(300024) was affected to a certain extent. At the same time, due to the repeated epidemic situation in some parts of China, the acceptance of Siasun Robot&Automation Co.Ltd(300024) installation of orthopedic surgery of the company was delayed, and the company failed to recognize the income in the reporting period as planned.
In the "other important information about the company's operation during the reporting period that needs to be reminded of investors" of "III. other reminders" in the company's report of the first quarter of 2022, the supplementary disclosure content is as follows:
"6. The risk that the company will not be profitable or its performance will decline further in a certain period of time in the future: the company's main product orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) sales promotion is affected by many factors such as market awareness and product price, and the sales volume is small, so the company has the risk of not being profitable in the short term. From the perspective of market awareness, compared with traditional orthopaedic surgery, orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) assisted surgery can assist doctors with more accuracy and less innovation Injury, faster completion of surgery, reduction of intraoperative X-ray radiation and compression of postoperative recovery time, but orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) into clinical surgery is still in its infancy, and it will take some time to improve the cognition of hospitals, doctors and patients about orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) auxiliary surgery; From the perspective of product sales price and use price, orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) of the company is a large-scale medical equipment, the purchase cost of the hospital is relatively high, and the purchase of Orthopaedic Surgery Siasun Robot&Automation Co.Ltd(300024) involves many links and processes, resulting in a long sales cycle, which increases the uncertainty of Orthopaedic Surgery Siasun Robot&Automation Co.Ltd(300024) sales; At the same time, for patients, the charges for orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) assisted orthopaedic surgery are generally higher than those for traditional surgery. Besides Beijing, most of the expenses for orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) have not been included in the scope of medical insurance reimbursement, and this part of the expenses need to be borne by patients themselves, which increases the difficulty of promoting the clinical application of the company's products; From the perspective of end customers, although the company's core products are sold in some key orthopaedic surgery hospitals (especially the third class hospitals), compared with medical institutions across the country, especially the high-end medical equipment field engaged by the company, the company has the characteristics of high investment in early research and development and long time in the approved listing and sales process. Combined with the situation of fund-raising projects to be implemented and being implemented by the company, The company needs continuous R & D investment.
From 2019 to 2021, the company's R & D expenses accounted for 33.55%, 54.53% and 70.37% of its operating revenue respectively. If the company continues to use its own funds and external financing for the R & D of Orthopaedic Surgery Siasun Robot&Automation Co.Ltd(300024) related projects, it may further aggravate the company's losses. "
2、 In combination with the opinions on supporting measures for centralized procurement and use of high-value medical consumables (artificial joints) organized by the state on March 30, 2022 officially issued by the national medical insurance bureau and the Health Commission, explain the impact of industrial policy changes on the company's orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) sales and the promotion of the business model of Orthopaedic Surgery Siasun Robot&Automation Co.Ltd(300024) minimally invasive surgery center jointly built with medical institutions;
The opinions on the national organization of centralized procurement and use of high-value medical consumables (artificial joints) (hereinafter referred to as the opinions) officially issued by the national medical insurance bureau and the health commission at the end of March 2022 stipulates the charging principle of artificial joint replacement surgery Siasun Robot&Automation Co.Ltd(300024) and requires that no separate charging items be set up, and the fee shall be charged in proportion based on the price of traditional surgery. In addition, the opinion also emphasizes the need to "implement the balance retention policy and coordinate the price adjustment of medical services". In areas where the price of artificial joint replacement surgery is significantly lower than the national median price and surrounding provinces, the price of relevant projects can be specially adjusted.
The opinions mainly focuses on the charges of artificial joint replacement surgery and joint replacement surgery Siasun Robot&Automation Co.Ltd(300024) . At present, the listed products of the company are mainly trauma and spinal surgery Siasun Robot&Automation Co.Ltd(300024) , so it has no direct and significant impact on the sales of the company's products. At the same time, the company is making dynamic adjustment according to the policy of centralized purchase of orthopedics, fine-tuning the price matching, protecting the previous users, and enriching the price configuration to meet the needs of different customers.
The profit model of CO building orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) minimally invasive surgery center business with medical institutions is to provide medical technical services for patients using orthopaedic surgery Siasun Robot&Automation Co.Ltd(300024) for medical institutions, and both parties shall make settlement according to the operation volume according to the contract. At present, the company's main products do not involve joint replacement surgery Siasun Robot&Automation Co.Ltd(300024) , so the release of the opinions has no significant impact on the promotion of the business model of the company's minimally invasive surgery center in the short term.
Considering that the company's TKA (total knee arthroplasty Siasun Robot&Automation Co.Ltd(300024) , tirobot Recon) products have been clinically incorporated, that is, the clinical trial operation has been completed, and it is expected to be on the market in 2023. After the company's total knee arthroplasty Siasun Robot&Automation Co.Ltd(300024) goes public, it will be directly affected by the opinions. However, since the charge of Siasun Robot&Automation Co.Ltd(300024) for artificial joint replacement surgery in the opinions is only stipulated in principle as "charge in proportion based on the price of traditional surgery", the specific proportion is not clear, which needs to be clarified by further laws, regulations or medical practice. Therefore, it is not possible to accurately judge the impact of the opinions at present. If further laws and regulations or medical practice make it clear that the price of Siasun Robot&Automation Co.Ltd(300024) operation cost of joint replacement decreases significantly, if the price of Siasun Robot&Automation Co.Ltd(300024) is high, the sales quantity will be seriously restricted, and the sales price of Siasun Robot&Automation Co.Ltd(300024) of joint replacement must be reduced to maintain high sales volume. However, at the same time, the price of Siasun Robot&Automation Co.Ltd(300024) operation cost of joint replacement decreased significantly, which is conducive to the increase of operation volume and the promotion of the company's joint construction of Orthopaedic Surgery Siasun Robot&Automation Co.Ltd(300024) minimally invasive surgery center.
To sum up, the opinions have no significant adverse impact on the company's product sales and the promotion of the business model of Siasun Robot&Automation Co.Ltd(300024) minimally invasive surgery center jointly built with medical institutions. However, after the company's joint replacement Siasun Robot&Automation Co.Ltd(300024) is listed, if further laws, regulations or medical practice make it clear that the price of joint replacement Siasun Robot&Automation Co.Ltd(300024) operation fee decreases significantly, it will have an adverse impact on the sales of joint replacement Siasun Robot&Automation Co.Ltd(300024) of the company, but it is conducive to the promotion of the business model of joint surgery Siasun Robot&Automation Co.Ltd(300024) minimally invasive operation center with medical institutions.
3、 Further explain the charging restrictions of the national centralized procurement policy on the company's relevant products or services and the potential adverse impact on the company's sustainable operation ability, and supplement and prompt the relevant risks in the annual report.
In the "IV. risk factors" (VI) industry risk "part of" section III Management Discussion and analysis "of the company's 2021 annual report, the risk tips shall be supplemented and disclosed:
In addition, the opinions of the National Health Care Commission on the establishment of artificial joint replacement (hereinafter referred to as "the opinions of the state health care Commission on the price increase of artificial joint replacement") shall be based on the "opinions of the state health care Commission on the price increase of artificial joint replacement" (hereinafter referred to as "the opinions of the state health care Commission on the establishment of artificial joint replacement" and "the price increase of artificial joint replacement" shall be paid separately in March 2024) "Implement the balance retention policy and coordinate the price adjustment of medical services". In areas where the price of artificial joint replacement surgery is significantly lower than the national median price and surrounding provinces, the price of relevant projects can be specially adjusted.
The opinions mainly focuses on the charges of artificial joint replacement surgery and joint replacement surgery Siasun Robot&Automation Co.Ltd(300024) . At present, the listed products of the company are mainly trauma and spinal surgery Siasun Robot&Automation Co.Ltd(300024) , so there is no direct significant impact on the sales of the company's current products.
Considering that the company's TKA (total knee arthroplasty Siasun Robot&Automation Co.Ltd(300024) , tirobot Recon) products have been clinically incorporated, that is, the clinical trial operation has been completed, and it is expected to be on the market in 2023. After the company's total knee arthroplasty Siasun Robot&Automation Co.Ltd(300024) goes public, it will be directly affected by the opinions. However, since the charge of Siasun Robot&Automation Co.Ltd(300024) for artificial joint replacement surgery in the opinions is only stipulated in principle as "charge in proportion based on the price of traditional surgery", the specific proportion is not clear, which needs to be clarified by further laws, regulations or medical practice. Therefore, it is not possible to accurately judge the impact of the opinions at present.
If relevant national departments introduce new policies in the future, including trauma and spinal surgery Siasun Robot&Automation Co.Ltd(300024) and joint replacement Siasun Robot&Automation Co.Ltd(300024) into the scope of policy application, and significantly reduce the price of Orthopaedic Surgery Siasun Robot&Automation Co.Ltd(300024) operation expenses, it is difficult for the company to achieve an ideal sales volume on the basis of maintaining the current gross profit margin of Orthopaedic Surgery Siasun Robot&Automation Co.Ltd(300024) in the future. " 4、 Opinions of the recommendation institution
After verification, the recommendation institution believes that:
1. The decline of the company's performance is mainly due to the epidemic, and the company has given sufficient risk tips.
2. The opinions on the national organization of centralized procurement and use of high-value medical consumables (artificial joints) is expected to have no significant adverse impact on the company's sales and co construction of minimally invasive orthopaedic surgery center business. The company has been actively studying and adjusting its business strategy, adapted to the market changes brought about by the new policy, and added risk tips.
(there is no text on this page, which is the signature page of China Securities Co.Ltd(601066) verification opinions on the reply to the inquiry letter of Tinavi Medical Technologies Co.Ltd(688277) 2021 annual report) signature of the sponsor representative:
Sun Dong, Lu danjun
China Securities Co.Ltd(601066) mm / DD / yyyy
