Theratechnologies Inc T.TH

RE:RE:RE:RE:RE:RE:RE:RE:RE:Downgraded to 3, from 8…. With everything going on?!?

[scarlet1967]

Again you said the market would value the protocol if they would add the interim arm to deal with the biopsy uncertainty now they just did that so now the futility analysis is adding uncertainty?What do you reckon the costs of enrolling 400 patients is 15 M? What would be the potential benefits? Removing "uncertainty". The partnership talks was mentioned earlier at the time the reason was not having enough sale force for a potential approved drug, so I believe it was always in their mind now our conservative board finally decided to go down that route due to the extra cost. The only difference is they have now the EMA onboard and de-risk a costly protocol adding the futility analysis. Would that make the protocol more attractive to a partner? In my opinion yes.

qwerty22 wrote:

That's not what I'm saying. Removing non-futility is exactly what is needed, dosing some non-hiv F2/F3 and biopsying them is exactly what I've always wanted. I would have taken it two years ago as a final Ph2 exploratory trial. I'd even still take it now as a Ph2 but I understand that the company don't want to give up on the value of the hard work in getting this protocol. I don't like it but I'm prepared to give them 12 months to see what they can unlock with partnering. We are on a path I don't like but I understand exactly why we are on it

What I don't buy is the extra 25% cost as the justification for the shift is plans from a thtx-led program to partnering. I believe the ability to shoulder the burden of risk inherent in the program is the real issue here but they are too reluctant to talk about that risk. Non-futility is not so much about the extra cost it causes but the extra risk it represents. That extra risk has been apparent to me for a long time, I expect it's been apparent to the company, I think it was apparent to the market and Ed Nash. The puzzling thing is they held on for so long to the goal of a thtx-led trial when it was fading away for so long.

The company has done this odd piece of gymnastics they probably should be applauded for. Non-futility says that clinically they haven't finished Ph2. Yet regulatory they've somersaulted over that to get a registrational trial. In the risky world of a NASH drug graveyard the market isn't buying into that so the company has been left with no possibility to move forward alone. They need a partner to shoulder the burden of risk of non-futility.

There has been amazingly little discussion of the implication of non-futility here. It's central to the way I understand the strengths and weaknesses of this program.

 

scarlet1967 wrote: I don't understand you, not long ago you said the futility analysis which was something you always wanted is not commercially justified based on 25% extra cost?? Now you are questioning why that extra cost tipped the company over to partnership idea..

 

qwerty22 wrote:

If he'd asked them more bluntly

Q1 How did we get here because for 12 months you've been represently a thtx-led Ph3?

Q2 What are the chances of a deal? Any interest yet?

Both reasonable questions.

Let's just unpick what the company want us to believe in it's most basic form.

1) Nash is a potential multi billion dollar asset.
2) Their program shows strong potential for success.
3) A 25% rise in costs (10-40 mil??) is stopping them moving forward internally.

That seems to be what they are selling and what you are buying. In that scenario they shouldn't be searching for a partner they should be looking for the cash. Honestly they are passing up a blockbuster drug for the sake of 10's of million of dollars? It doesn't add up.

He is right to wonder how we ended up with the decision to not move forward alone, 25% increased costs does not come close to a rational explanation, it has to be much more than that.

He is right to wonder about the chances of unlocking value with a partner. It's a significant challenge.

NASH really was the only big commercial development in that CC. 

 

scarlet1967 wrote:

 

 

Below is his questions re NASH, did he asked anything about the protocol itself? No

Did he asked any questions re sales? No

So the analyst isn’t interested to understand the prospects of NASH or sales going forward? He isn’t Intrested in oncology!

All he was asking about was related to funding the protocol, partnership etc.

Then we have another analyst who hasn’t acknowledged they have started the oncology trial.

This is what happens when you put all your efforts to support the valuation by the help of these journalists.

 

“Hi, good morning guys. So I wanted to understand, so I know that we just got the protocol now approved, I guess, officially, but we've known since roughly almost a year ago now that you were not going to be allowed or the agency was not going to be receptive to you looking at only NASH patients that had HIV. So I'm just trying to understand now that you're -- now that you're deciding to partner and your cash balance is what it is, which is going to drive the decision, but we already kind of knew what your cash balance was then too, so just what's changed between since last year and now with regards to your decision to look for a partner for the Phase 3 NASH?

 

Thanks, that was helpful. And I guess the second part to that is just with regards to the modeling this. I mean, obviously this could go -- this can take many different forms as you mentioned. But of the six Phase 3, six companies running Phase 3 right now for NASH they're all in this alone. And just wanted to know on that side, have you already guys have -- have you already had people having accessed the data on a confidential basis showing interest or is this kind of an effort that's now that you have a busy [ph] guy on Board, is this something that's just now starting new from scratch?”