Forum Topics NEU NEU Strawman Meeting

Pinned straw:

Added one year ago

A few quick takeaways from the $NEU SM meeting with Jon just concluded (in these I am purposefully not going over ground covered in previous SM discussions, but have to give a big shout out to @Nnyck777 for great insights which broight me to the party!

  • $NEU appear commercially very astute - getting back the 4 indications for NNZ-2591 in doing the $ACAD ROW deal is a master-stroke
  • Building a sales, marketing and supply chain capability in orphan drugs is less of a challenge than mainstream pharma or medical devices because of the patient community and small number of specialists who support them
  • Competition - I perceive this a lower threat than I have discussed earlier, but I will still be watching the Anavex Phase III result
  • Its hard to see $NEU not getting an acquisition offer if NNZ-2591 Phase II Phelan-McDermid read-out is positive. (I hope they have a good defence valuation logged with the Board, as that is the biggest risk to long term holders.)
  • NNZ-2591 in the success case is multiples of trofinetide, and $NEU aim to maintain exposure to more of the total value. But success is not assured. However, if it yields a positve impact in humans for P-McD in the PII readout, then that potentially de-risks the other indications given the mouse model findings. (December is a BIG potential catalyst.)


Investment milestones: what I am focused on going forward:

  1. Attend $ACAD results call in late-Oct/Early Nov (Q3 sales, Q4 outlook)
  2. Await NNZ-2591 Phase II readout in December
  3. Monitor for news of regulatory filing for Trofinetide in Europe and/or Japan
  4. $ACAD annoucement of sale of PRV (and value)
  5. Monitor Anavex Phase III report towards year end

1. and 2. are both potential material SP re-rate catalysts, and would also drive my holding. A negative result in NNZ-2591 is not a thesis-breaker and, if there is a SP pull-back, could even present a further buying opportunity.

I know I am sitting on a SM valuation of $20; but that is a top-down scaling back of results of a range of scenarios which are actually $12.50-$58.00, which assumes nothing from Fragile-X or NNZ-2591. Rather than settle on a single number, I think it is better at this stage to consider the range. I will update my model post-Q3 $ACAD results.

I've taken another bite of $NEU, and will consider more at milestones 1. and 2. above.

Very happy to have this risk-reward profil in my portolio.

Disc: Held in RL (2.4%) and SM

Scoonie
Added one year ago

Excellent rundown by mikebrisy.

Well worth having a look at some of the early user (parent) experiences. You get the sense that the diarrhea side effect is significant and hints at why, even with the full drug reimbursement that appears to exist in the US for around 85% of Rett's sufferers, take-up will likely be well below 100%.

Still at around 50% take-up after say 12 months, this would put NEU on a PE of less than 10 on royalties alone. This does not include milestone payments, Dayblue ROW and the potential giant value uplift unleased if NNZ-2591 Ph2 is succesful. A very cheap medical company.

Below is a medical specialist in the Midwest talking to parents at a Retts symposium. A very balanced discussion and the Dr is throughout a good advocate for the drug.

Daybue: Known Side-Effects and Treatment - YouTube

Below is 3 parents whom have used Daybue talking about their experiences. Cut straight to minute 20. All experiences are very affirming and positive. However all reported the diarrhea issue.

IRSF Parent Panel: My Trofinetide Clinical Trial Experience - YouTube




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Nnyck777
Added one year ago

Thanks so much @Strawman for landing Jon and for running a great Q & A and interview. Jon seemed a lot more relaxed and informal than in previous interviews that I have seen. 

There were some really important insights that were gained that I haven’t heard before today. 

On a personal note thanks for asking all my questions – I was also the anonymous questioner (I hadn’t realised I needed to add my name on slido – woops)

I think a really key point was made between 20 min – 25 minutes in the interview. 

Key insight:

1)    If Phelan McDermid trial is successful in December Neuren will take the results straight to FDA to plan phase III. This was the first time I have heard Jon confirm the timeline and really adds to the excitement as a shareholder. This is a really important point as the momentum of this stock will just keep building – and likely keep adding value for share-holders.

Other important notes:

2)    Note that safety has not been a concern and that is largely what an open label phase I study is about. Neuren has successfully jumped another drug safely from an animal model to a human trial. Acadia also had access to this data and $100 million was added to the deal to lock in NNZ2591 for Fragile X and Rett (I think this is a super important point). Efficacy will be interesting – fundamentally we are dealing with a similar functioning drug to Daybue but a more bioavailable model. I love to see Jon’s enthusiasm around this. 

3)    Interested parties (plural) for NNZ2591 for US rights – Neuren is certainly on the radar. 

4)    The lack of hiccups around insurance/ Medicaid and Medicare was reassuring and backed up by the stellar speed of uptake of Daybue.

5)    Jon once again re-iterated that potential gene therapy would be an added benefit and unlikely to supplant Daybue – he has emphasised this before. 

6)    Jon’s surprise at the conservatism of analysis and broker models – so far they have been wrong on:

a.     A the price of the drug

b.     The speed of uptake 

c.     Suggesting to me the very conservative modelling out there by mainstream brokers

7)    A real emphasis on the ORPHAN drug model – I personally was really pleased to hear this. There is a lot of scuttlebutt about Alzheimers or Autism I personally think these kind of large scale studies are much more difficult to run and less likely to produce definitive end points. I am glad they are sticking with what they know. 

8)    4 Indications are more than enough to build an enduring and financially very worthwhile business. 

9)    His glowing comments about ACADIA are consistent – yes while they might go it alone it is also possible that ACADIA and NEUREN will get rolled up and bought as a package. 

@Scoonie agree diarrhoea issue has been a prominent issue on forum discussions however there is a lot of optimism around creative solutions families are coming up with if willing to get through the initial teething issues. Another point to concentrate on as Jon has commented that NNZ2591 is unlikely to have these issues due to the smaller doses needed in the drug.

Thank you once again. Where else can you so easily get access to CEOs as a retail investor – other than Strawman?

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mikebrisy
Added one year ago

Agree wholeheartedly @Nnyck777. Big thanks @Strawman. Outstanding.

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