This is probably the best interview I have seen so far for this company. It is NOT an overview of the company - so if you are not familiar already with TMDX, this is not the place to start. However, if you are familiar and want to listen to very in-depth questions and answers, this was great. It is from the Morgan Stanley global healthcare conference this week.
A few highlights:
Things were going well in 2020 until Covid - which basically shut down transplants in many of the largest centers where they were doing the majority of their business. Things are slowly getting back on track but not yet back to 100%.
They talked quite a bit about the “Service” model status and deployment. It is progressing as planned, and they see this as laying the foundation for strong growth in the coming years.
They currently have 3 products (OCS for lung, heart, and liver) and each of those can be used with organs from "Donors after Brain Death (DBD) or “Donors after Circulatory Death”. Lung OCS is fully FDA approved for both DBD and DCD and is the only commercial product.
Heart for DBD - the trial is complete and the FDA panel review is scheduled for early October. They talked quite a bit in the video about the upcoming review. It is too much for me to write out, but TMDX is ready and confident in their ability to address all questions from the FDA.
Heart for DCD - this trial is currently ongoing. The news article link I posted last week was partly in relation to news on the heart DCD. In the interview, TMDX stated that the number of transplant centers participating in this trial increased from 9 in Q2 up to 22 in Q3. They expect to finish enrollment in 4Q2020.
Side note - the Heart DCD has “Breakthrough Designation” from the FDA. So, once the study is complete they should receive expedited review from the FDA. I am not an expert, but from what I have read this breakthrough designation is a pretty big deal and not very common. They also have breakthrough designation for Liver DCD.
Liver DBD - the person from Morgan Stanley conducting the interview stated “I’ve been looking at your data sets for 15 years… I would say that your liver data set is maybe the strongest data set we’ve seen.” This study finished late 2019, the data was published in Q2, and the data has been submitted to the FDA for approval. It was a randomized study with over 300 patients all in the US. Superiority was demonstrated in 2 outcomes both short-term and long-term. They are hopeful for approval in 1H2021.
Liver DCD - they did not talk about this in the interview, but this trial started in 2020 and is in process.
Kidney OCS - they stated that the current plan is to not start the trial for this until at least the end of 2021. They want to focus on completing approval and commercialization of the other products for the next year.
TMDX has not been a strong performer in the last year. However, I think everything is pointing toward very strong growth for the next several years - assuming they get the FDA approvals that are anticipated.
Long TMDX 6%
Analogkid70 - thank you for your our ate on TMDX. it is indeed an interesting company that I follow, but haven’t invested in yet.
What is your opinion on the heart data? It seems that there are some concerns about this data compared to baseline that need to be addressed. It would be a blow, if they need to do a second trial, because the first trial was messed up because of an adverse selection in patient population.
I’m don’t have the expertise to be able to make a personal judgement on the data from the trial. Also, when dealing with the FDA, things can be unpredictable.
But here’s what I do know:
TMDX has already successfully navigated the FDA process for their lung OCS device for both DBD and DCD donors. 2 separate trials and 2 FDA approvals. So, they have a positive record of success.
Heart OCS has been sold commercially to centers in Europe for several years. It is used for both DBD and DCD hearts there (according to company statements at one of the investor conferences last year). Studies were conducted in Europe also to validate results, and the product remains in commercial use.
The FDA review coming up is for “DBD donor” Heart OCS approval. The initial study is complete, and that is what the FDA will be reviewing. But, TMDX is already conducting a second study for DBD donors under a “Continued Access Protocol”. This allows them to collect more data while waiting for the FDA review. In one of the recent interviews, I believe the CEO indicated that the data from this CAP will be part of what they discuss with the FDA. They started enrolling for this CAP late last year, so they should have a good number of additional data points from it.
In addition to the above, TMDX is also in the process of another trial for Heart OCS with “DCD donors”. This is scheduled to finish enrollment in early 4Q20. Several centers in this study have recently reported positive experiences (in news articles). The DCD program has FDA “Breakthrough Designation”, so it will get expedited review when the data is available. My point here is that even if there is a delay in the DBD approval for heart, they are still likely to get the DCD approval which will still give them a lot of sales of heart units starting sometime next year. And my assumption is that the DBD would also eventually be approved even if there is a delay.
The CEO has stated consistently that TMDX is confident in the data from the first heart trial. I have listened to many interviews, and he has never wavered or equivocated on this point. Based on what I have heard, I believe him. But as I said at the start, I don’t have the expertise to judge the sufficiency of the data myself.
I wish I could give a more definitive answer to your question, but that’s the best I can do. I can not guarantee DBD Heart will be approved in the first review, but based on all I have read, I personally feel confident it will eventually be approved. If there is a delay in approval, the stock will probably have a temporary drop - but there are several other catalysts coming in 2021 that should still help support the stock (deployment of the service organization, DCD Heart, DBD Liver, DCD Liver, international re-start post covid, Kidney OCS trials to start end of 2021.
The biggest risk would be more dilution if they have more delays. If COVID stays strong in 2021 it would probably reduce the number of transplants again, and if the heart approval is delayed, then dilution could happen. They already did a secondary offering a few months ago, and they have reduced expenses - so they are good on $ for now. But they are hiring people for the service side of the business, and if they did have to repeat a trial there would be expense associated with that.
High risk / high reward IMO. Maybe not for the feint of heart. One strategy might be to wait for the FDA panel results before buying if you are not comfortable. However, if it is approved I personally expect a big initial price jump.
Long TMDX 7.7%
p.s. - even though it’s not SaaS, this is another great example of an IPO spike and fade. Opened in 2019 at $20 - went to $30 in a few weeks after IPO - dropped to around $18 6 months later. It has not been a great performer so far, but I believe the next 2 - 4 years could be great. I also think this year would have been good if not for COVID.
The FDA review for the Heart OCS was delayed and that is the cause for the big drop today. I know nothing other than what was in the press release. I personally added 15% more shares today at the lower price. I’m not telling anyone else what to do, but I believe this is a temporary setback. I could be wrong.
I also picked up some shares on the dip - although my allocation is relatively small. The FDA decided that it needed more time to review shorter and longer term data that was already collected. It seems to me that it would be malpractice for the FDA to have not reviewed existing data.
The postponement of the meeting, which was-previously scheduled for October 7th, 2020 will allow the FDA time to review additional, already collected, short and longer-term data from the OCS Heart EXPAND trial and EXPAND Continued Access Protocol. The FDA’s Office of Health Technology 2 Cardiovascular Devices) has communicated to TransMedics that it will review the additional data expeditiously to allow rescheduling of the Advisory Panel meeting to occur in the near future.