Specialist
Former director at Abiomed Inc
Agenda
- Key cardiology medical device sector trends relating to Abiomed (NASDAQ: ABMD)
- Regulatory landscape overview including Abiomed's issues around FDA product approval
- International expansion efforts and viable regions for penetration
- Competitive landscape and Abiomed's positioning vs Abbott (NYSE: ABT), Edwards Lifesciences (NYSE: EW), Boston Scientific (NYSE: BSX) and Medtronic (NYSE: MDT)
- H2 2021 outlook, growth prospects and strategic assessments
Questions
1.
What key trends and developments in the cardiovascular device space have you been paying attention to over the past year or so?
2.
How has Abiomed’s story more specifically evolved over the past few years?
3.
How is procedural acuity trending more broadly in the US as it relates to cardiovascular patients? How much of a material tailwind does a more highly acute patient profile present for Abiomed longer term, particularly given your commentary around Impella’s use case for very sick patients?
4.
What’s your updated overview of coronavirus as it relates to Impella procedural volumes? Abiomed reported strong utilisation metrics on its Q2 2020 earnings call. How much of this do you believe was due to pent-up demand vs strong performance, appreciating this might be a bit speculative?
5.
What is your outlook for the rest of 2021 in terms of patient utilisation and procedural volumes?
6.
What is the typical regulatory path for bringing new devices to market such as the Impella product portfolio? What are some common hurdles in securing FDA approval and how has Abiomed fared historically in navigating this environment?
7.
How has Abiomed responded to the 11% Medicare reimbursement cut from CMS [Centers for Medicare and Medicaid Services]? How material of a headwind is this reimbursement pressure, especially given that more than 50% of the elective PCI [percutaneous coronary intervention] market is over the age of 65?
8.
What levers can Abiomed pull to offset reimbursement pressures and preserve margins?
9.
What do you make of Abiomed’s efforts to reorganise its sales force over the past year or so? How might the revamped team affect their commercialisation strategy and penetration prospects?
10.
Would you say sales rep churn is a material issue for Abiomed and if so, how can the company mitigate this challenge?
11.
How are you assessing the pricing environment across Abiomed’s Impella portfolio? How have the reimbursement and pandemic challenges affected Abiomed’s pricing strategy for Impella CP and the Impella 5.5?
12.
How are you assessing the pricing environment across Abiomed’s Impella portfolio? How have the reimbursement and pandemic challenges affected Abiomed’s pricing strategy for Impella CP and the Impella 5.5?
13.
How are you evaluating the recent clinical studies Abiomed released around the Impella ECP? How would you frame the financial opportunity for this offering?
14.
What’s the value-add of Abiomed’s XR sheath, and to what extent does it complement and drive adoption for the Impella CP? Could you help us quantify any additional uptick here?
15.
What prevents Abiomed from replicating Edwards Lifesciences’ sheath? What might be causing this product to be delayed?
16.
What do you make of Abiomed’s product pipeline and R&D efforts? Which new products are you excited about for revenue growth or innovation?
17.
What is your assessment of Abiomed’s Breethe acquisition in April 2020? How has the bolt-on helped to augment the company’s existing product portfolio?
18.
Can you elaborate on Abiomed’s ability to integrate Breethe and PreCARDIA, especially given that the company hasn’t made an acquisition since Impella in 2006? Do you anticipate any material integration challenges for these tuck-ins?
19.
Could you outline the competitive landscape and Abiomed’s competitors across the Impella portfolio? How is the company positioned relative to big med device players in these product lines? What areas of differentiation would you note?
20.
How does Impella stack up to competitors in terms of clinician education? How much of a meaningful difference does clinician education have on product uptake?
21.
How would you assess Abiomed’s ability to continue to gain traction in international markets? Which regions and countries represent the most attractive opportunity for further expansion, perhaps from a patient population, reimbursement or regulatory perspective?
22.
How concerned is Abiomed about IP infringement in APAC markets such as India and China? Do you think this has been a material hurdle and dragging on expansion in those areas?
23.
What is Abiomed’s philosophy around trials, especially the difficult cardiogenic shock trials? When might Abiomed be able to get over 50% penetration in shock trials in the US, Germany, Japan or any other country?
24.
What are your thoughts on the negative press Abiomed received in late 2019 over mixed data surrounding product efficacy? Has that data debate from 2019 been put to bed by the clinician community?
25.
What is your 12-18-month outlook for Abiomed? What are the most important factors to monitor over that time frame?
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