After re-listening to parts of Panel Meeting, I think it is safe to assume:

- $TMDX would only be used for extended-criteria hearts only. For ex. >=4hrs ECCT

- Existing SOC volume won't convert over to OCS (unless run back PROCEED Trial to prove OCS better than SOC)
Updated U.S. TAM table above...

- Total Donors (DBD + DCD) same as previous version (30.4K) per $TMDX 10K

- "Already utilized" organs now reflect actual '20 OPTN data (instead of back-calc from 10K)

- Split in unutilized organs between DBD and DCD extrapolated from 10K
- 'Newly-Enabled Organs TAM' excludes 'already utilized' organs (assuming that what can be done today w/ SOC will STILL use SOC... not $TMDX OCS)

- Newly-enabled TAM (all organs) for this reduced by 21% from Full TAM which includes 'Already Utilized' volumes
- Math uses 81% Extra Utilization in DBD Heart per EXPAND trial but can actually flex to 84% per EXPAND + CAP... either way still around $2.9Bn (Main star in the show is DCD)

- Again these numbers don't include international (rest of Key Markets) or potential Kidney biz
- Must apply haircut to TAM b/c a chunk of ppl die @ home (can't get to them till too late), but National Program logistics mapping to partially offset this (would snowball w/ more regions)

- A lot remains to be seen re: how surgeons use OCS if approved (indications etc.)
5/ Our view is that demand can be explosive.

Say for hearts, 6.5mm ppl in U.S. have heart failure w/ 5-10% of patients in advanced/end-stage.

That equals 487.5K potential recipients (at midpoint).

Judging from this alone, the supply should be filled if approved.
6/ In 2020, 12,588 donors died and donated >=1 organ, while there were only 3,722 Heart Transplants.

In response to Al Stammers on FDA Panel the other day, CEO Waleed confirmed that w/ just DBD alone (using EXPAND+CAP extra utilization)...

Transplant volumes can double.
7/ Our math gets to 4,454 extra hearts or 2.2x today's volume.
If can achieve, that's $200mm in sales for that alone ($45K/Tx).

DCD will then open pool to potential 16,943 hearts. If achieve, that's another $762mm.

(All of this while disregarding already utilized hearts)
8/ DCD Heart will have readout of top line data
- May / may not have Panel meeting (has breakthrough designation, so potential streamline process)
- Expect to file PMA in Q3'21
- Approval probably 9-12mo post-file (so '22)

By that time, National Program likely very strong.
9/ Moreover, all the math drive off 30.4K assumption of donors per $TMDX 10K.

IMO 30.4K sounds low given 2.8mm deaths a year in U.S. + 165mm signed up to be organ donors.

Filtering down w/ CDC by age, place of death, etc... 30.4K still looks small.
10/ DBD + DCD newly enabled hearts give sales opp of $962mm total.

If you apply haircut of 50% assuming death @ home, families refusing to sign off, logistics issues...
It's still $480mm for just U.S. hearts.

Haircut gets smaller as National Program gets efficient.
11/ National Program can help $TMDX strong-arm competitors so I have fewer concerns about other players gaining lots of U.S. share.

At $33.50/share, I have EV of $884.7mm using FDSO.
10.2x EV/'22 Sales
5.9x EV/'23 Sales

Execution matters & have to keep retesting. That said...
12/ Don't think $TMDX is expensive but my time-frame is long. My views only.

I think 22K DCD deaths of which 16.9K hearts can potentially be used by OCS is a huge number / sales opp that will be a landslide when approved.

DCD donor hearts possible only b/c of $TMDX.
13/ That alone gives $762mm total sales opp.

In addition, surgeons would embrace DCD hearts.
It won't be on the fence.
There's no competition.

I reckon the ramp up will be much FASTER than we expect for DCD b/c there's no other choice and can provide immediate benefit.
14/ OPTN has multiple data pulls which spit out similar numbers but are actually different.

This table below now exactly ties the # of utilized hearts to $TMDX's sponsor presentation.

DBD Opp $201mm
DCD Opp $764mm
Newly-Enabled Organ U.S. TAM $3.0Bn vs. $2.9Bn in 1st slide.
Please look at last tweet in thread for a revised table with 3,658 hearts and the corresponding outputs.

OPTN has a lot of data and I linked a different row to populate first table up top. Would recommend looking at last table in thread instead for 100% clarity.
This 50% haircut can presumably include scenarios where Tx surgeon choose to wait longer to use SOC donor heart nearby instead of OCS extended-criteria heart.

As noted on Panel, there will be cases where Tx surgeons prefer to harvest hearts locally w/ SOC to get 95% survival.

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More from @genghis_pon

6 Apr
Schroder just started presenting at $TMDX Meeting
Schroder crushed it with his closing sentence for his segment saying OCS technology not only solves current quantity in the waitlist but can also allow an increase in waitlist size.

He literally said that there are plenty of good hearts out there - - just need to use OCS.
Chris Mullin (Independent Advisor) brought on by $TMDX reiterated the Piecewise FDA model is not valid nor reliable for long-term death extrapolation.
Read 67 tweets
5 Apr
1/ $TMDX results are positive, but FDA's job is to question things every step of the way.

In spirit of being informed / keeping a balanced view, below are some FDA concerns:

- Trial design (single-arm study)
- $TMDX's subjective definition of extended-criteria hearts
2/ - Extended-criteria hearts in EXPAND also include single-criterion >=4hr cross-clamp time, which actually make it somewhat overlap w/ PROCEED group

(i.e. imperfect definition extended-criteria heart)
3/ - 65% as questionable performance goal (b/c $TMDX defined goal after benchmarking w/ old studies that achieved 22.6%-32.0%, but those studies didn't use standard definition of PGD and don't know proportion of extended-criteria pop in those studies)
Read 10 tweets
4 Apr
1/ We've mentioned before that extra utilization for DBD Hearts is 81% when using $TMDX.

The comparison between OCS and UNOS SRTR in the tables below is pretty powerful. Look at % in p. 36.

OCS can expand pool into donors w/ various risk factors (previously unused organs). ImageImage
2/ 19% of 93 hearts in study turned down.

Main reason being lactate rising, which is a biomarker mentioned by Dr. Schroder in presentation earlier.

Out of 75 hearts used...
24% age >65%
64% history of mechanical circ support
16% F-to-M mismatch
15% renal dysfunction
... ImageImageImage
3/ 6.3hr cross-clamp (while w/ cold storage, 85% of hearts transplanted are <4hr, so major UPLIFT)
*Highest cross-clamp time in study of 11.4hr... wow
while minimizing cold ischemic time

Primary effectiveness (on 30-day survival and no severe ISHLT PGD): 88% vs. 65% perf goal ImageImage
Read 8 tweets
19 Mar
[THREAD] Detailed thoughts on $TMDX below

- "Key Geographies" Supply-Driven TAM
- U.S. Supply-Driven TAM
- Demand for Organ Transplants (Lung/Heart/Liver)
- Larger donor list --> larger recipient list
- Quick revenue sizing based on current demand
- More positive catalysts
1/ Company-provided TAM from $TMDX's 10K of $8.02Bn for lung, heart and liver.

This is supply-driven i.e., sizing opp by unlocking utilization of previously unused organs.

"Key Geographies" per $TMDX include US, Canada, EU and Australia.
2/ We extrapolate $TMDX's TAM for U.S. by applying utilization assumptions from above to Company-provided U.S. figures.

We get U.S. TAM of approx $3.65Bn.

Important to know b/c a successful FDA panel will first benefit U.S. commercial efforts, then trickle over to int'l after.
Read 13 tweets
18 Mar
1/ Senator Bill Frist, MD ($TDOC Board Member for 7 years) on CEO Jason Gorevic:
“One thing that obviously impressed me about your leadership is your ability to say where you’re going based on, as you've said, a plan from 7 years ago - the pyramid that you’ve always presented...
2/ ...that this is where we’re going to be someday. Everybody presents that, but you made it real block by block. I still have those initial slides of your presentation. As you’ve said, none of this is new in your mind.”
Link >>
3/ Am confident in $TDOC. Despite recent events: (i) MDLive acquired by $CI in Feb '21, and (ii) Dr. on Demand merging with Grand Rounds in Mar '21, and (iii) $AMZN Care offering services to employers across the nation by summer '21...
Read 10 tweets

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