Qiming Medical-B (2500.HK): TAVR's continuous restoration and internationalization process continues to advance

華泰證券 · Sep 5, 2023 00:00

TAVR 植入量修复推动1H23 收入端稳健增长，国际化进程持续推进启明医疗公告，1H23 实现收入2.56 亿元（+21.7% yoy），净亏损3.7 亿元。

公司1H23 收入端实现稳健增长，主因：1）TAVR 手术量自2M23 持续修复（2M-6M23 植入量同比+50%）而产品综合ASP 维持稳健；2）海外市场在TPVR 产品的带动下快速增长（1H23 公司海外收入+60%yoy，主要由VenusP-Valve 贡献）。展望2H23，由于4Q TAVR 手术旺季+公司海外商业化进程持续推进，但考虑新品商业化爬坡与研发费用投放节奏，我们预计公司2023-2025 年收入6.32/9.58/15.07 亿元，并看好公司净利润于2025 年转正。使用DCF 估值法（假设WACC 10.3%，永续增长率 1.5%），我们给予启明10.98 港币目标价与“买入”评级。

TAVR：4Q 手术旺季或驱动植入量进一步修复，三代产品进展顺利公司VenusA 系列产品于1H23 实现收入2.30 亿元（+17% yoy），主因自2M23 起TAVR 择期手术持续修复（公司1H23 TAVR 植入量2300+）。我们看好全年公司TAVR 收入yoy 冲击50%（对应5000 台植入量），考虑4QTAVR 手术旺季推动下，VenusA 系列产品或稳步回升。展望长期，公司自主研发的三代产品 PowerX 与Venus Vitae（均即将启动关键性临床研究）或凭借其革命性干瓣设计，为公司TAVR 管线发展注入长足发展动力。

TPVR：海内外商业化仍处早期，看好2H23 齐发力公司TPVR 产品VenusP-Valve 于1H23 实现收入2519 万元（+177% yoy），主因VenusP-Valve 自4M22/7M22 分别获批欧盟CE MDR 及中国NMPA上市后，海内外疗法渗透率持续提升（1H23 植入量环比2H22 提升80%）。

我们看好该产品2023 年收入翻番，主因：1）海外市场全年有望冲击1000万美金收入，考虑公司产品陆续欧洲多个国家获得市场准入并纳入医保支付；2）国内市场收入爬坡收益产品商业化拓展持续推进，公司作为国内首个上市的TPVR 产品或享有先发优势。此外，公司仍在努力开拓其他海外市场（8M23 美国获批IDE，日本确认性临床准备中）。

二/三尖瓣：Dragonfly 已递交国内上市申请，重磅管线助力长期增长我们看好公司二/三尖瓣管线到2030 年冲击18 亿元收入，考虑：1）重磅Dragonfly 与德晋医疗合作（已递交中国NMPA 上市申请），公司指引其或于2024 年上市，我们看好其2030 年冲击近10 亿元收入。2）重磅产品Cardiovalve（三尖瓣返流性适应症处于国际多中心确认临床，二尖瓣返流处于早期可行性研究），我们看好其自2026 年陆续上市。此外，公司所布局的肥厚性心肌病产品Liwen RF 已于2023 年3 月完成确认行临床试验入组，公司指引其或于2024 年上市。

风险提示：商业化风险，定价风险，研发风险，TAVR 渗透率提升缓慢。

The restoration of TAVR implants boosted steady growth on the revenue side of 1H23. The internationalization process continued to advance Qiming Medical's announcement. 1H23 achieved revenue of 256 million yuan (+21.7% yoy) and a net loss of 370 million yuan.

The company's 1H23 revenue side achieved steady growth, mainly due to: 1) the number of TAVR surgeries continued to be repaired from 2M23 (+50% compared to 2M-6M23 implants) and the overall product ASP remained steady; 2) the overseas market grew rapidly under the impetus of TPVR products (1H23's overseas revenue +60% yoy, mainly contributed by Venusp-valve). Looking ahead to 2H23, due to the peak season of 4Q TAVR surgery+ the company's overseas commercialization process continues to advance, but considering the rise in commercialization of new products and the pace of R&D expenses, we expect the company's revenue from 2023-2025 to 632/958/1,507 million yuan, and we are optimistic that the company's net profit will be positive in 2025. Using the DCF valuation method (assuming WACC 10.3%, sustainable growth rate of 1.5%), we gave Kai Ming a target price of HK$10.98 and a “buy” rating.

TAVR: The peak season for 4Q surgery may drive further restoration. Third-generation products are progressing smoothly. The company's VenUSA series products achieved revenue of 230 million yuan (+17% yoy) in 1H23, mainly due to continuous restoration during TAVR elective surgery starting from 2M23 (the company's 1H23 TAVR implants 2,300 +). We are optimistic that the company's TAVR revenue will impact 50% (corresponding to 5,000 implants) throughout the year. Considering the 4QTAVR operation season, VenUSA series products may rise steadily. Looking forward to the long term, the company's self-developed third-generation products, PowerX and Venus Vitae (both of which are about to launch key clinical studies), or with their revolutionary dry valve design, inject significant development impetus into the development of the company's TAVR pipeline.

TPVR: Commercialization at home and abroad is still in its early stages. We are optimistic that 2H23 Qifali's TPVR product Venusp-valve achieved revenue of 25.19 million yuan (+177% yoy) on 1H23, mainly because Venusp-Valve has continued to increase since 4M22/7M22 was approved for the EU CE MDR and China NMPA, respectively, and the penetration rate of domestic and international therapies has continued to increase (1H23 implants increased 80% over 2H22).

We are optimistic that the product's revenue will double in 2023. The main reasons are: 1) the overseas market is expected to hit 10 million US dollars in revenue throughout the year, considering that many European countries have successively obtained market access and are included in health insurance payments; 2) domestic market revenue is rising and commercial expansion of revenue products continues to advance. As the first TPVR product to be listed in China, the company may enjoy a first-mover advantage. Furthermore, the company is still working to develop other overseas markets (8M23 US approved IDE, Japan is preparing for confirmed clinical trials).

Dragonfly has submitted a domestic listing application. Heavy pipelines help long-term growth. We are optimistic that the company's two/tricuspid pipelines will hit 1.8 billion yuan in revenue by 2030. Consider: 1) Major Dragonfly's cooperation with Dejin Medical (it has submitted a Chinese NMPA listing application). The company is leading it to go public in 2024. We are optimistic that it will hit nearly 1 billion yuan in revenue in 2030. 2) The blockbuster product Cardiovalve (tricuspid valve reflux indications have been clinically confirmed at multiple international centers, and mitral valve reflux is undergoing early feasibility studies). We are optimistic that it will be marketed one after another from 2026. In addition, Liwen RF, a hypertrophic cardiomyopathy product laid out by the company, was confirmed for clinical trials in March 2023, and the company indicates that it may be listed in 2024.

Risk warning: commercialization risk, pricing risk, R&D risk, TAVR penetration rate is increasing slowly.

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启明医疗-B(2500.HK)：TAVR持续修复 国际化进程持续推进

Qiming Medical-B (2500.HK): TAVR's continuous restoration and internationalization process continues to advance

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启明医疗-B(2500.HK)：TAVR持续修复国际化进程持续推进