Global TAVR procedures are evolving with more than $5B market size at present and continuous evolution expected in upcoming years estimated to reach $10B by 2028 mainly driven by indication expansion (low risk approval), therapy awareness and technology advances. Despite this evolution, diagnosis and treatment rates of Aortic Stenosis remain low with majority of underserved AS population coming by over 70 years old patient population. (Source: Edwards Lifesciences Investor Presentation December 2021).

Looking to TAVR market statistics in South Europe, Greece is one of the countries that TAVR procedures are growing rapidly and is still an underpenetrated market.

Key highlights of Greek TAVR market in the first half of 2022 include:

Market Analysis 1H 2022

-607 implants

– 20 active centers

-Average Selling Price (ASP) around 15K€, stable

-Growth of implants vs PY: 39%

-TAVR procedures per million inhabitant’s ratios: 125(EU average 150)- Underpenetrated market

-Self-Expandable (SE) Valves:80.9% (vs 80.3% FY2021), Balloon Expandable (BE):19.1% (vs 19.7% FY2021).

Note:There is a stable trend in the SE/BE ratio and it remains far away from the Global market shares averages. (As a comparison remind to everyone, the US study registry of 2019 which includes the use of Balloon Expandable Valves in 72.3% of the cases while 26.7% were self- expandable and 1% the mechanically expanded valves.

For V-in-V TAVR, 53.3% were self-expanding valves, 46.6% balloon expandable valves and 0.2% were mechanically expanded valves with the limitation of course of less commercially available valves in US vs Europe at the study period).

-20 active centers. 1 center has already done more than 100 TAVR procedures, 4 centers have done more than 50 procedures, 3 more than 30 and another 9 more between 15-25 implants with only 3 remain below the limit of 10 procedures during the first half of 2022.

-Top 6 higher volume hospitals represent 61% of the market (vs 67% FY2021)

-Lower volume hospitals represent 39% of the market (vs 32% FY 2021)

-Public TAVR:43.6%, Private and Hybrid: 56.4%

-Highest volume month June 22: 132 TAVRs, Lowest volume Jan 22: 73

-Projection FY2022: 1250-1350 implants and around 19-20.5M€ in sales values

-Market ecosystem has stabilized. Hospital Payments have been improved both in public hospitals and private centers with few exemptions that need close monitoring.

-Prerequisite of patient approval from Central committee of HealthCare System from a committee consist of 7 Interventional Cardiologists and 4 Cardiac Surgeons before implant is still a decisive therapy approval factor.

-Official Reimbursement remains 18.150 Euros for TAVR devices while the average market price is around 15K Euros. Important note is that lower market prices include Value Based Healthcare agreements that include Volumes, favorable payment terms and overall collaboration of Group Purchase Organizations with Medical Device Manufacturers partially offset from public hospitals implants increase and favorable account mix.

Competition analysis- Market shares

– Medtronic (MDT) is still the dominant company in Greece with 47% market share in implanted units growing 17% vs same period last year and have around 6pps market share loss due to growth slower than the market (39%).

Having said that, they have kept their ASP stable vs FY2021 resulting to an overall market share of 48% in sales values. MDT’s local clinical team remains the most important asset moving forward and compensates so far for management pitfalls in some accounts.

Key Takeaways: MDT maintains the leadership position in TAVR in Greece with great clinical support team and good clinical execution. However, it is important to note that soon, MDT’s leadership position will have higher competitive pressure since competitors are continuously investing in new headcounts and aggressive sales strategies. A fact that is already observed in the market with MDT unable to follow market growth resulting to market share loss.

–Edwards Lifesciences (EW) continues to be around 13.8% in market share in implanted units and around the same in sales volume growing 32% vs same period last year out of which 50% (53% FY2022) still coming from one hospital, while they also have 1 exclusive account and implants in 10 centers. We need to stress again the fact that this low market share for many years in the row, is not indicative of the company’s reputation, TAVR global leadership and BE global market share statistics. Going deeper on the account analysis, EW has lost even the premium pricing justification since average market prices are quite similar with the exemption of BSX which has more aggressive pricing.

Looking to the positive trends, EW is investing and adding a new clinical specialist recently hired from Philips and a new regional field THV manager who is expected to be based in Greece to support team’s efforts to change the ballgame and position EW where it deserves to be based on the product quality and company’s history.

Apart from that, EW locally, is paying the bill of weak Value-Based Healthcare Strategies vs Competitors in major implanting centers, and continuous aggressive penetration of Myval in Balloon expandable segment that has doubled its TAVR procedures vs same period last year and reaching already 31 TAVR implants.

Key Takeaways: EW performance in Greece is still compromised compared to global statistics and technology product superiority especially since EW global market share is around 50%. EW is investing locally in new headcounts at present to change the picture of the Greek market being one of the lowest TAVR penetrated countries in developed world and Europe. Despite the headcount investment, a clear strategy and faster execution should be established and deployed soon to close a significant market share gap locally.

-Abbott (ABT) is more than doubling its TAVR procedures in the 1H2022 adding 40 more vs same period last year, gaining almost 3 pps vs FY2021 in market share landing to 11.8% in implants in 13 hospitals, with average ASP discipline and nice product mix between public and private accounts. Market share in sales remains around 11.5% due to price discipline. At the same time, ABT has also added a clinical specialist to TAVR team to support future growth and penetration and remains to be seen how it will deploy the sales tactics in the effort to primarily gain market share vs MDT and BSX in SE segment.

Key Takeaways: ABT has managed product limitations compared to closed competitors last year and tries to position the new delivery system more aggressively. Like EW, ABT’s headcount investment will need time to adapt in order to start creating added value to the team. Furthermore, ABT’s strategy needs a nice balance and optimal resources allocation moving forward since the flagship product of Structural Heart segment is always Mitraclip and Triclip and the ballpark there is completely different than TAVR at present.

-Boston Scientific (BSX) is continuing firing all cylinders locally after many years of product limitations adding more than 50 TAVR implants growing 59% in units vs same period last year with a better balance and dilution of TAVR implants across BSX accounts adding 3.3 pps vs FY2021 results and landing to a 22.6% market share in units and around 1 pp lower in sales values due to aggressive price positioning in key accounts and account mix.

Main drivers of this result apart from aggressive price positioning is robust clinical team approach and maturity and focus to execution. BSX is also looking to expand its team in Cardio to continue supporting the forecasted growth in TAVR.

Key Takeaways: Great performance, Targeted account management and networking from the BSX team. Nice mix of sales and clinical execution, aggressive price positioning, optimized market segmentation that compensate for a product clinically proven, well established lacking same quantity of clinical evidence vs top competitor.

-Last,Meril’s Myval from India is continuing its penetration in the Greek TAVR landscape. It has performed more than double implants from 14 to 31 in 5 accounts vs same period last year and has been flat vs the second half of last year with one account counting for more than 61.3% of total units and a market share of 5.1% gaining 0.6 pps in units vs FY2021. One should expect that main driver is aggressive price positioning. Well surprisingly is not!! Myval has also kept a stable market ASP resulting to a market share in sales value of 5.2%. Great customer segmentation and prioritization strategy. Meril is clearly looking after Greek market and there are rumors that are looking for additional resources and strategic moves establishing Greece as a hub for Eastern Europe and Middle East regions soon.

Key Takeways:. Great performance from Meril combined with distributor model (all the other competitors are direct), solid strategy and price positioning, optimized account prioritization and stable average market price. Current capabilities and network can increase market share with a stable trend however if Meril would like to position the company against BIG4 in TAVR, a different regional strategy should be implemented to support these growth initiatives.

-In terms of Local strategy and Tactics and Value-Based Healthcare execution tactics, MDT and ABT continue to be the most active, offering bundling product packages in many private centers trying to get advantage of private centers consolidation which is evolving with ongoing aggressive positioning and acquisitions of US funding vehicles (CVC Capital Partners). What is worth to mention is that US funding vehicles have also made significant investments in the private sector in Cyprus by acquiring private hospitals in the country and establishing faster pathways for innovative technologies in Cyprus . (By the way, Cyprus TAVR market is really following Greek TAVR procedures trends with high double-digit growths every year).

-Analyzing decision power local schemes, MDT, ABT and BSX and Meril have a local decision power for total Structural Heart Portfolio while EW has Regional Manager outside of the country still having the decision power in sales tactics and pricing and isit clear that this fact is compromising the speed and effectiveness of the overall company execution and cannot support company branding and premium pricing strategy effectively in Structural Heart. Hopefully with the addition of the new THV Field Manager, EW will close the gap in decision , execution and sales tactics delays vs competitors.

(Source: Hospital unofficial registries, Local congress presentations, industry data, Company’s Investor presentations, confidence data level greater than 98%)