TransMedics Group (TMDX) investor relations material

Strategic vision and integration

• Pursuing deeper integration into the national transplant ecosystem, aiming to become a member of OPTN and expand impact on organ transplantation in the U.S.

• Built a national organ procurement infrastructure (NOP) with dedicated air and ground logistics, digital ecosystem, and a network covering nearly 30% of U.S. transplant volume.

• Sees regulatory approval as key to further integration, with potential decisions expected by end of 2026, likely making this a 2027 event.

• Emphasizes a win-win scenario for patients, the transplant system, and stakeholders if integration is achieved.

Clinical trials and competitive landscape

• ENHANCE and De Novo trials are central, with focus on generating level one clinical evidence and maintaining FDA oversight.

• Competitors have raised concerns about trial comparisons, but the approach is to maintain high standards and adapt protocols as needed.

• Upcoming protocol updates and clarifications for ENHANCE will be discussed at ISHLT, aiming to resolve confusion for both Part A and B.

• Kidney program is expected to be the largest to date, with simultaneous U.S. and Europe clinical trials under consideration; more details expected by Q3 or year-end.

Operational and international expansion

• European expansion is progressing, with investments in infrastructure and partnerships, and no significant geopolitical barriers perceived.

• Announced OCS budget approval in Italy and building a dedicated European transportation network.

• GCC region initiatives are ongoing but impacted by geopolitics; Europe remains the near-term focus.

• Fuel price fluctuations are managed through established surcharges and cost-efficient logistics, leveraging owned fleet for better control.