TMDX

Investment Analysis Clubs Saul’s Investing Discussions
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I posted about this company a couple weeks ago, so I won’t go into a long explanation again here - see my previous post if you want details.

I am only posting this message to inform folks that TMDX is expected to publish the results from their latest trial (Liver PROTECT trial) sometime in the next couple weeks. They have hinted in the last ER call that the results are extremely good. The description that the CEO gave for the results was:

“Related to the liver PMA, the trial results are known to us, and they are extremely, extremely exciting to us, and we cannot wait to publicly announce the results……We’re hoping that given the strength of the results that we’re going directly toward a major submission of manuscript to a major publication. And we hope that that will happen over the next several weeks. The results are very, very strong. They’re the first of its kind type results.”
“…the results, when they become public, they will speak for themselves. We have already initiated the continued access protocol (CAP) for it. We expect that the review process within the FDA will be within the targets we’ve set. Our PMA filing will be according to our original plan in Q2, which is six months ahead of our original plan. So we’re not expecting any reduction or pullback on the liver. The opposite is true. Once these (trial) results become public, we expect that the CAP will be rapidly rolling, and we’re probably going to extend the CAP. And we will leverage the results to encourage the FDA to hopefully accelerate the review process.”

TMDX had previously stated that they were going to share the results of this Liver trial at the American Transplant Congress - which starts next Saturday. If the results are as good as they say, it could lead to a boost in the stock. Right now, the stock is below it’s IPO price.

A second catalyst coming in the next few months is the expected approval of their Heart OCS device from the first heart trial.

A final catalyst is the continued roll-out of their service organization - “Perfusion Services” which is a completely new type of organization in the organ transplant field. I go into detail on this in the research summary I posted a couple weeks ago.

If anyone is remotely interested in this company, you might want to do some research and consider getting in prior to the release of the upcoming data report.

FYI - the stock suffered greatly during COVID because many transplant hospitals had to stop doing transplants - both in the US and internationally. COVID also delayed the FDA review of their heart OCS trial results - they were supposed to have the review and approval in Q2, but it is now expected in Q3. COVID also delayed the start of their latest trial for OCS Liver specifically for DCD organs (Donated after Circulatory Death). So, results suffered a little, and the stock was knocked way down, but IMO it was temporary due to COVID. 2021 should be a huge year for the following reasons:

  • Heart OCS will be fully approved and commercial
  • Perfusion Services will be fully operational in most zones of the US
  • Liver OCS should get fully approved in Q1 or Q2
  • International expansion will resume (it was paused this year due to COVID)
  • Heart and Liver for DCD donated organs will complete their trials and possibly publish results.
  • It is not officially announced, but it is expected that they will kick off Kidney OCS trials in 2021.

Final Note - it is likely they are going to have a secondary offering. They recently filed a shelf registration. Their cash position is pretty good, but with COVID unknowns I think they are planning to raise some more cash “just in case”. It’s hard to predict what a secondary offering will do to the stock price - I personally think it is priced in, but I just want to make sure people are aware that it is probably coming and could have a short term negative impact.

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2

Well, both of the things I predicted were just announced this morning.

Secondary offering of ~ $60M. Current Market cap is ~ $340M. So about 20% dilution. Not the best news, but its the safe thing to do in the era of COVID uncertainty.

Second piece of news is the announcement of Liver PROTECT trial results.
https://investors.transmedics.com/node/7141/pdf

Some highlights from that announcement:

  1. "The trial achieved its primary clinical objectives by meeting both the primary and secondary effectiveness and safety endpoints. For the primary effectiveness endpoint, the use of OCS Liver resulted in a significantly lower incidence of early allograft dysfunction (EAD) compared to control (17.3% OCS vs. 30.5% Control p=0.009) across both the donors after brain death (DBD) and donors after circulatory death (DCD) cohorts in the trial. EAD is the most common severe complication that occurs early after liver transplantation. EAD serves as a potential indicator of preservation injury to the donor liver and is associated with significant increase in ICU and hospital stay. "
    I’m not a Dr., so my understanding of this is not as an expert. But I believe that after liver transplants there are a certain % of people who develop significant problems with the “graft” of the liver into the new body. This results in much longer stays in ICU (= higher cost) and it results in higher mortality rates among people who have the graft dysfunction. One of the major selling points for the TMDX device is that it significantly reduces the incidence of this type of problem - that is true for all organs TMDX has tested on - lung, heart, and now liver. In this trial there was ~ a 44% reduction. That saves a lot of money for insurance companies, and it results in many more patients who survive and thrive after the transplant.

  2. “…patient survival at 30-days post-transplant was high and non-inferior to control (99.3% OCS vs. 99.3% Control p=0.0004).”
    Nothing big here - it’s equivalent to control in this item.

  3. “In addition, the use of OCS Liver resulted in a significantly lower incidence of ischemic cholangiopathy complications at 6 months post-transplantation (1.4% OCS vs. 8.5% Control p=0.005), a leading cause of late graft failure after liver transplantation.”
    I can’t explain exactly what this complication is, but the reduction in it is large with the TMDX device - 85% reduction.

  4. “In addition to improved graft outcomes achieved with the OCS Liver System, we have seen in our clinical experience during the trial significant improvement in safety in the conduct of liver transplantation with adverse intraoperative reperfusion events being virtually eliminated after the use of the OCS Liver System,” said Dr. Marwan Abouljoud, MD, Director of the Henry Ford Transplant Institute and a co-investigator of the OCS Liver PROTECT Trial. “I believe this will open the gateway to using more livers for transplantation safely.”
    I don’t know exactly what is meant by “adverse intraoperative reperfusion events” (I think TMDX will elaborate if they present at the conference that starts next week, or it will be clarified when the results are published in a journal). But, it sounds significant.

The main point is that there is a long waiting list of people who need a liver transplant, and there are not enough livers currently available. The TMDX device makes many more organs usable for transplant, and it simultaneously results in better outcomes after transplant. Win/Win.

I’m not sure which direction the stock price will move based on both pieces of news (offering vs. trial results), but the company continues to demonstrate superior performance of their system over the current standard of care (which is to put organs in a cooler on ice).

Keep them on your radar.

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