Specialist
Former VP at Abbott Laboratories Ltd
Agenda
- Recent trends and developments within the medical device space, focusing on LAAC (left atrial appendage closure) devices
- Comparative analysis of Abbott’s (NYSE: ABT) Amplatzer Amulet against Boston Scientific’s (NYSE: BSX) Watchman FLX
- LAAC’s US TAM opportunity and market growth runway
- Abbott and Boston’s relative sales force acumen and clinician education efforts
- 2023 growth outlook, disruption in LAAC from upstarts and device innovation prospects
Questions
1.
What major trends and developments have you been following in the LAAC [left atrial appendage closure] market over the past 12 months that might better inform our discussion?
2.
How do you assess the underlying market growth strength in LAAC? Do you think a 20% CAGR over the next five years is realistic?
3.
Could you do a deep dive comparing Abbott’s Amplatzer Amulet offering against Boston Scientific’s Watchman FLX? How does each product compare in terms of ease of use for clinicians, pricing and relative innovation? What are the key areas of differentiation to note?
4.
In patients with high risk for bleeding undergoing clinically indicated LAAC, use of the Amulet device vs the Watchman FLX was associated with a similar residual LAA patency and lower peridevice leak rates at transoesophageal echocardiography, but higher procedural complications, according to findings from the SWISS-APERO clinical trial unveiled at TCT [Transcatheter Cardiovascular Therapeutics] 2021. Amulet also had substantially lower rates of paravalvular device leaks. What are your takeaways from this comprehensive clinical study, as well as more recent clinical data readouts from TCT 2022? How would you juxtapose Amulet’s wins with the higher number of complications?
5.
Amulet was reporting pretty consistent volume increases since its launch in late 2021, although there was a flattening from June to July 2022. How much or little would you read into that as a potential harbinger of Amulet’s market share beginning to plateau?
6.
What’s your pricing outlook for LAAC devices over the next couple of years? How do you juxtapose the premium pricing position from these products’ innovation moats with compression on health system margins? Could we see pressure to ASPs?
7.
What major improvements has Boston made to the Watchman FLX in newer iterations of the device to protect against encroachment from the Amulet?
8.
What could be the impact of factor XI inhibitor drugs potentially coming to the LAAC market in a couple of years?
9.
What’s important to understand about flexibility around device sizes in terms of treating more patients and delivering better outcomes? Amulet boasts eight different sizes for its product, as you mentioned. How differentiated is that capability, especially considering the somewhat convoluted shapes of the appendages from patient to patient?
10.
Are there any remaining glaring weaknesses in the Watchman or Amulet devices? Where do you see room for innovation or improvement?
11.
What has been Abbott’s go-to-market approach to roll out the Amulet and maximise commercial uptake? What has the company learned from past product launches?
12.
What’s your assessment of the relative sales force strengths at Abbott and Boston? Who do you think has a better incentive mix or product acumen? How much do the considerations of whether to sell the product in electrophys or cardiology, as you mentioned, play a role here?
13.
You said there have been some potential benefits and drawbacks to the bundling of the drug-eluting stents with other products. Has Boston burned any bridges with clinicians, and how difficult might it be to repair some of those relationships?
14.
How likely are surgeons to stick with one manufacturer or vendor? If they’re already using Boston drug-eluting stents, are they more likely to opt for the FLX, from either an equipment purchasing or brand loyalty perspective? Does that create any stickiness?
15.
How does Amulet stack up in terms of ease of use for clinicians? What has been Abbott’s strategy to reduce onboarding and clinician education times?
16.
Where do you anticipate relative US market shares to settle in three years between Watchman and Amulet?
17.
Where do you think Abbott will look to expand its capabilities? Are there any other complementary products the company could build out or acquire to make its overall structural heart bundle – alongside the MitraClip and Amulet – stronger?
18.
How far away could Abbott be from entering the tricuspid market? How would you assess the innovation and regulatory barriers to commercialisation for tricuspid regurgitation?
19.
Could you do a deep dive into the competitive dynamics between the Amulet and Watchman in Europe? You noted that Amulet has been making staunch gains in the region. Are there any materially different go-to-market considerations in single-payer systems that could affect how these dynamics unfold?
20.
Which other geographic markets represent attractive regions to move into next, in terms of patient populations or friendly regulatory environments?
21.
How are you viewing the threat from other players or upstart companies entering the market and disrupting Abbott and Boston’s leading positions?
22.
How do you anticipate consolidation dynamics within the LAAC space to materialise over the next few years? Do you think we’ll see some of the behemoths get aggressive in potentially acquiring some upstarts with differentiated approaches or technologies to complement LAAC?
23.
Why haven’t we seen a name such as Edwards Lifesciences become more involved in LAAC? Might that change in the next few years?
24.
What are your thoughts on the respective company cultures or management styles at Abbott and Boston? How do these dynamics impact their go-to-market efforts and grander goals in a novel area such as LAAC?
25.
How would you quantify the opportunity in heart failure? What are your thoughts on interatrial shunts and other procedures that might unlock the next frontier of growth for some cardiology behemoths?
26.
Is there any risk for Abbott of cannibalisation of the LVAD [left ventricular assist device] business from the IASD [interatrial shunt device]? If you think about an indication such as IASD precluding the need for an LVAD, how are players balancing expansion considerations vs potentially cannibalising other parts of the portfolio?
27.
To summarise, what should be the top 2-3 strategic priorities for Abbott regarding maximising commercial uptake of the Amulet in 2023?
28.
Is there anything we haven’t touched on or that you’d like to reiterate regarding the LAAC market?
29.
What is your 12-18-month outlook for the LAAC market? Could you highlight the most important factors to monitor to gauge wins and losses between the Amulet and Watchman FLX?
