TransMedics Group, Inc. (NASDAQ:TMDX) Q2 2020 Earnings Conference Call - Final Transcript

Aug 05, 2020 • 04:30 pm ET

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TransMedics Group, Inc. (NASDAQ:TMDX) Q2 2020 Earnings Conference Call - Final Transcript

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Executive
Waleed Hassanein

allow transplant activities to recover before bringing these patients back in the waiting list and letting that waiting list continue to grow.

Despite these challenges posed by the pandemic, we made meaningful progress on our commercial, regulatory and clinical initiatives throughout the second quarter of 2020. Since the trough in April through early May, we've experienced recovery of transplant activities across many regions in the U.S.

As we have light -- as we have highlighted previously, resuming transplant activities is a priority for many hospital systems. We're seeing continuing recovery. However, we remain cautiously optimistic given the emergence of new hotspots in key regions in the U.S. were major OCS centers reside.

With that context, let me now shift to a review of our Q2 results. Our second quarter net revenue was $3.4 million, which represent a 40% overall decline from second quarter 2019. Given our strong first quarter -- first half '20 net revenue was up 6% compared to first half 2019. Through the quarter, we'd recognized revenue for all three organs, OCS organ programs.

OCS Lung was the most heavily impacted by COVID in Q2, given the virus impact on donor lungs, and the new testing mandates that were implemented on donor -- lungs donors.

Our OCS Heart DCD program continued to accelerate and grew in Q2 to a total of 51 transplants, up from 26 at the end of Q1. In June, we filed our OCS Liver PMA to FDA and the review process is currently underway. We expect to receive a list of review questions and hold our 100-day meeting -- review meeting with the agency in October to map out the approval process and timeline.

We're also continuing to make significant progress with our national service model offering, and in the second quarter, conducted significant outreach to major OPOs across the U.S. We are confident that our service model will be active in many regions in the U.S. in the second half of 2020.

In May, we successfully closed an equity offering that contributed approximately $75 million in net proceeds to buttress our balance sheet and give us a long, robust runway to drive our business growth. We are grateful to all new and existing investors who participated in this financing.

Now, let me shift to review our key strategic milestones and catalysts for 2020 and 2021. Most significantly, the FDA has informed us that our OCS Heart panel will be held virtually to review our PMA application on October 7th. We are looking forward to that important day and we are laser focused on securing a strong positive panel vote to support the approval of the OCS Heart system.

Assuming a positive panel vote, we would expect approval within three to four months. As mentioned, we remain ahead of schedule for the OCS Liver approval. And following our earlier than expected PMA submission, continue to expect approval in 2021. As we look ahead, we also expect a continued rebound of OCS Lung programs as