Specialist
Former committee member at Edwards Lifesciences Corp
Agenda
- Key trends and developments in the cardiovascular device industry, focusing on Edwards Lifesciences (NYSE: EW)
- TAVR (transcatheter aortic valve replacement) market opportunity, growth runway and Edwards’ penetration prospects
- Edwards’ expansion into the TMTT (transcatheter mitral and tricuspid therapies) sector and ability to compete with first-mover Abbott Laboratories (NYSE: ABT)
- International landscape, including headwinds in China market
- 2022 outlook – anticipated R&D efforts and potential consolidation
Questions
1.
How are you assessing the growth runway of the global TAVR [transcatheter aortic valve replacement] market? Why isn’t this market growing faster given the amount of potential unmet need?
2.
Could you estimate the global TAVR market’s growth runway over the next 5-7 years? Could there be an inflection point in market penetration?
3.
How would you delineate Edward Lifesciences’ quantifiable market opportunity in asymptomatic TAVR?
4.
What is key to tapping into the asymptomatic TAVR market? How can this population be addressed if people aren’t aware of their heart issues?
5.
At what point along the innovation curve is the TAVR market? When might there be eventual pricing erosion that is often observed across more mature medtech companies as products become less innovative and more commoditised?
6.
Do you think Edwards could ever grow successfully in China in light of the dynamics you outlined? What might be an optimal strategy in this market and other developing markets given the stratified two-tiered nature of the country’s socioeconomic demographics?
7.
How might the cannibalisation in the surgical segment from TAVR affect Edwards’ strategy? How much could Edwards continue to invest in the ancillary surgical business given its diminishing growth outlook?
8.
Do you believe the mitral repair and replacement segment is a high-growth market? It has developed slower than initially expected. Edge-to-edge technology is now a standard of care, but far from optimal, considering the complexity of the patient and the medical treatment alternatives.
9.
Why is the mitral replacement product so difficult to make? Could you discuss the physiology vs product design and cost-effectiveness in mitral?
10.
The TMTT [transcatheter mitral and tricuspid therapies] market resembles the initial TAVR market when treatment options are somewhat limited. To what extent do you think the TMTT market is underappreciated and could be a much bigger opportunity?
11.
How are you assessing Edwards’ growth runway and penetration in TMTT? How crucial is the segment for the company to maintain a double-digit growth trajectory over the next several years?
12.
What is key for Edwards to try to tackle the TMTT market without a first-mover advantage? Abbott already enjoys a somewhat dominant position. How do you assess Edwards’ ability to carve out share at Abbott’s expense?
13.
What are your thoughts on Edwards’ sales force and clinician education efforts across segments? How do you assess its relative go-to-market strategy execution against the broader market?
14.
How do you assess Edwards’ competitive positioning vs Medtronic in the US TAVR market? Do you think Medtronic can gain any share given Edwards’ first-mover advantage and innovation moat?
15.
Boston Scientific might enter the TAVR market in 2024 with the Acurate Neo2. How likely is it to receive FDA approval given the original Neo missed primary end points last time?
16.
How much should we read into the Abbott Portico’s approval in the US and Medtronic’s Evolut FX launch? Could these new offerings materially disrupt the competitive landscape? What’s the trickle down impact on Edwards?
17.
What are your thoughts on Boston Scientific discontinuing the Millipede mitral valve repair programme? How much should we read into this and does this substantially strengthen Edwards’ positioning in mitral repair?
18.
How might macroeconomic inflationary pressures impact the pricing strategy for Edwards and other players? Do you think Edwards can reprice its product suite, at least in line with cost inflation?
19.
Could you discuss the barriers to entry in surgical and critical care? How defensible is Edward’s positioning from smaller upstarts? Do new entrants enjoy any nimbleness or innovation advantage?
20.
How can outsiders get comfort that there’s more viable and significant innovation coming to TAVR? Is durability key here since the Sapien3 is the current industry gold standard?
21.
What might be the key trends in product innovation and development to come, whether it’s integrating blood pressure monitoring capabilities or other capabilities? What product upgrades should we be excited about in TAVR?
22.
Is there anything else you’d like to highlight around Edwards Lifesciences?