Neuren Pharmaceuticals Limited

ASX:NEU

Neuren Pharmaceuticals Limited

ASX:NEU
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$12.14 (-3.2%)
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#14
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Pinned straw:
Nnyck777
Added 2 months ago

https://www.businesswire.com/news/home/20241016133678/en/Acadia-Pharmaceuticals-Announces-Health-Canada-Approval-of-DAYBUE%E2%84%A2-trofinetide-for-the-Treatment-of-Rett-Syndrome

Daybue has just received approval for use in Canada. This will add to the US sales numbers.

Lets see if this can halt the continued slide of Neu share price - despite good news.
Tom73
Added 2 months ago

CEO Jon Pilcher will be presenting at next Tuesday's ASX CEO Connect live online event.

To register use the link: CEO Connect October 2024 (asx.com.au)

Recordings are available for registered attendees if you can't make the time.

Rgs

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mikebrisy
Added 2 months ago

@Nnyck777 yep - here's the ASX release and here is the $ACAD release.

Although the Canadian market is only 1/10th the US, we will likely see one or two quarters of outsized impact due to the "bolus of pent-up demand" that we saw in the US. Plus, the sales are at the higher royalt rate 12%.

This could potentially bring $500m into view for 2025 - because on my modelling for US-only, they are less than 50% likely to hit $500m in 2025. (My p10,p50,p90 model is ($387m, $493m, $584m). Adding $20-$30m from a FY in Canada increases the odds.) 12 months of Canada changes that equation significantly.

I don't think the market has been assessing this impact correctly, and so if they effectively launch in January, then there is a chance that the momentum in 1Q and 2Q - at the margin - leads to a mild positive over-reaction on long-term growth for North America.... which of course then reverses in Q3 or Q4!

The timing could not be better, as the 3Q24 result will be clean (US only), and perhaps even the 4Q result. With that, I'll be able to tune my model, and get a much better handle on the DAYBUE s-curve.

Potentially, this also buys time for more good news on NNZ2591 to materialise.

So as Jon said on the last SM meeting news flow over the next 12 months could really turn sentiment. Newsflow catalyts

  • Canada approval
  • NNZ 2591 PMS Phase 3 endpoints agreed with FDA
  • Canada launch
  • NNZ-2591 PMS Phase 3 starts
  • NNZ-2591 PH post-Phase 2 FDA meeting
  • Filing DAYBUE in EU


For me, the next datapoint from US sales is key, as it will start to put some robustness under the DAYBUE revenue scenarios.

On it's own, I don't think there will be a large reaction to this info (I'm usually wrong) but it is part of hopefully a good series of positive newsflow. The only potential fly in the ointment could be a poor Q3 DAYBUE result.

Disc: Held in RL and SM


17
Slideup
Added 2 months ago

@Nnyck777 ,@mikebrisy

I haven't seen any reference to the pricing structure for Canada, do either of you know what it is likely to be?

I'm thinking it will be lower than the US, which is now around $395k per full treatment dose, this is from memory, but I remember that they had put a price rise though earlier this year from the $375k initial launch price. But just no real idea of what kind of discount it will be.

Assuming same list price as US and roughly 1/3 of patients start/maintain treatment it will add another $112m revenue and should get them over the line for the next $500m milestone payment, probably in 2026 though. Also adds another US$13m to NEU annually.

I've also heard Acadia mention that they are tracking to the midpoint of guidance, so I think the next quarterly should create a solid base for Neu to build off.

14
mikebrisy
Added 2 months ago

@Slideup good point on price.

My understanding is that Canada is more active in regulating prices. Also, there is research that shows that orphan drug prices in the US tend to be 1.7 times higher than the EU, at launch. While this is an average and there will be large variations from case to case, it does indicate the direction. Canada is more like the EU on pricing than the US.

I'd therefore expect the launch price for DAYBUE in Canada to be perhaps 50-70% of that in the US.

So, at US $395k per patient, assume 60%, so $237k pppy.

600-900 patients, assume 1/3 at end of year 1 (net of churn), so 250. Approx. linear ramp = 125 patient-years = $30m Year 1(2025),... slightly more refined calc than my $20-$30m first estimate. Maybe I'm out by a bit out, but I'd see it hard to get above $40m...front-end pent-up demand bolus effect.

But it might put the $500m milestone in reach (from 40/60 to 60/40?) We'll know more in a couple of weeks.

The data from the conference was "tracking just below midpoint of guidance".

Hopefully, at least $ACAD will now have the experience of 2023 and 2024, so we should get some decent guidance for 2025 when it comes.

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