1. 医保覆盖扩大驱动美国CGM 市场扩增，加之庞大患者规模和高渗透率，公司CGM 出海美国大有可为。据CDC 最新数据，2023 年美国糖尿病患者群体达3730 万人、占美国人口的11.3%，且在本土巨头德康、雅培等的市场培育下，患者血糖监测意识极高，2020 年CGM 在1 型、2 型、妊娠糖尿病患者中的渗透率就已达到26%、9%、4%，显著高于欧盟五国、中国等地区。2023 年4 月，美国医保局CMS 进一步扩大了CGM 的医保覆盖，市场规模有望大幅扩容，据William Blair 预测，2025 年美国CGM 市场规模或将达到100 亿美元，在2-3 年内实现翻倍以上增长。公司CGM 为全球首个三代技术产品，性能比肩国际龙头，上市后有望凭借成本和性能优势抢占市场份额、贡献可观业绩增量。Incidents:
On December 18, 2024, the company issued an announcement that the self-developed “Continuous Glucose Monitoring System” product has passed the FDA 510 (k) acceptance review and officially entered the 510 (k) substantive review stage.
Reviews:
1. The expansion of medical insurance coverage is driving the expansion of the US CGM market. Coupled with the huge patient scale and high penetration rate, the company's CGM has great potential to go overseas. According to the latest CDC data, the number of diabetic patients in the US reached 37.3 million in 2023, accounting for 11.3% of the US population, and under market cultivation by local giants such as Dekang and Abbott, the patients' awareness of blood sugar monitoring was extremely high. In 2020, the penetration rate of CGM among type 1, type 2, and gestational diabetes patients reached 26%, 9%, and 4%, which is significantly higher than in the five European Union countries, China and other regions. In April 2023, the US Health Insurance Administration CMS further expanded CGM's health insurance coverage, and the market size is expected to expand significantly. According to William Blair's forecast, the US CGM market may reach 10 billion US dollars in 2025, more than doubling in 2-3 years. The company's CGM is the world's first three-generation technology product. Its performance is comparable to that of international leaders. After launch, it is expected to seize market share and contribute considerable performance growth through cost and performance advantages.
2. With the subsidiary's channel network+online platform two-wheel drive, CGM's global volume is expected to accelerate. The company's two US subsidiaries, Trividia and PTS, were basically integrated, and both achieved profits in the first three quarters of this year. Among them, Trividia is deeply involved in the field of blood sugar monitoring, and is the third largest blood sugar meter manufacturer in the US. The channel network covers more than 80 countries and regions, including the US, the UK, Australia, and Mexico, and is expected to provide solid channel support for the company's CGM listing and sales in the US. It is expected that online and offline collaborative sales will be carried out. Furthermore, for the European region, which is currently the second largest market for CGM, the company obtained registration certifications in various countries such as MDR and the United Kingdom, and joined A. on November 29. MENARINI DIAGNOSTICS S.r.l. signed an exclusive distribution contract for a period of seven years to sell the company's first and second generation CGM custom-model products under a joint brand in more than 20 countries and regions in Europe, which is expected to accelerate the release of the company's products in the European market. In Asia Pacific, Africa, South America and other regions, the company has also successively completed CGM registration and accelerated localization and regional market expansion. At the same time, the company continues to promote performance upgrades and iterations of CGM products to enhance product competitiveness. On December 16, the company's second-generation CGM was approved by NMPA. Compared with the first generation, it not only has better portability and comfort, but is also upgraded to integrated implantation, no assembly required, and the product size has been further optimized. With the continuous consolidation of product performance and cost and price advantages, the company is expected to accelerate the global expansion of CGM with the help of channel layout in mature markets in the US and Europe, and local construction in potential markets such as the Asia-Pacific region.
Profit forecast: We expect the company's 2024-2026 revenue to be 4.298, 4.926, and 5.67 billion yuan, respectively, with year-on-year growth rates of 5.88%, 14.61%, and 15.12% respectively, and net profit to mother of 0.373, 0.523, and 0.604 billion yuan, respectively. The year-on-year growth rates are 31.21%, 40.06%, and 15.59%, respectively. Corresponding to the current stock price PE is 40, 28, and 25 times, respectively, maintaining the “recommended” rating.
Risk warning: CGM sales fall short of expectations, progress in new product development and registration falls short of expectations, domestic and foreign market expansion falls short of expectations, subsidiary performance falls short of expectations, intensified market competition, industry policy changes, and other systemic risks.
