Maintained dominant position in Chinese TAVR market. Venus reported 2021 revenue of RMB416mn, up 50.6% YoY, primarily driven by sales growth of VenusA-Valve/ VenusA-Plus in China (+49.0%YoY), as well as sales growth of TriGUARD3 in Europe (+180.3%YoY). The Company recorded other income and gains/ other expenses of RMB307mn/ RMB 389mn, respectively, which was primarily attributed to ~RMB240mn fair value adjustment of contingent payables related to the acquisition of Keystone. In 2021, Venus achieved approximately 3,600 TAVR implantation volume (+65% YoY), indicating ~70% of total market share in terms of implantation volume. Venus’s 2nd generation product, VenusA-Plus, contributed ~35% of the total implantation volume in 2021. Thanks to the sales growth in high- margin VenusA-Plus product, the Company maintained a steady ASP of approximately RMB120,000 per unit during 2021. In 1Q22, Venus has recorded 900 sales volume in TAVR amid the challenging COVID-19 pandemic. Management aims to realize 5,000 to 5,500 TAVR implantation volume in 2022E, with VenusA-Plus to contribute more than 50% of total sales volume. We also expect the Company to further expand its hospital coverage from 360 in 2021 to 410 in 2022E.
To provide comprehensive transcatheter solution for structural heart diseases. Leveraging in-house innovation platform and BD efforts, Venus has established a product portfolio consisting of all four valves for treatment of structural heart diseases. As of aortic valves, VenusA-Valve and VenusA- Plus has secured the largest market share in China, while VenusA-Pro is to be launched in China in 2022E. In 2021, the Company has initiated FIM studies of the two new generation TAVR products (Venus-PowerX and Venus-Vitae), as well as its aortic valve repair product (Leaflex). We estimate Venus to start MRCTs of Venus-PowerX and Venus-Vitae by 1H23E.Furthermore, VenusP-valve is to be the first self-expanding TPVR product launched in the EU, with CE marking to be granted very soon. VenusP-valve may also receive commercial approval in China in 2022E. In Jan 2022, Venus completed the acquisition of Cardiovalve with a TMVR/TTVR product under development. The Cardiovalve system is currently undergoing multi-center clinical trials in the US and Europe, with 13/11 implantation cases completed for mitral regurgitation/ tricuspid regurgitation patients, respectively.
Maintain BUY. We expect VenusP-Valve to obtain CE approval in 1H22, and three products to be approved by NMPA in 2022E (VenusP-valve, TriGUARD3, VenusA-Pro). Driven by the launch of VenusP-valve and sales growth in TriGUARD3, we expect Venus’ overseas revenue to reach c. US$10mn in 2022E. We forecast revenue to grow 70%/ 45%/ 47% YoY in FY22E/23E/24E, and revised our DCF-based TP to HK$24.44.