Pinned straw:
@Remorhaz not a lot of insight there (wasn't expecting any) .... albeit, true to say that coming to the party at this stage means you have to have your eyes wide open as to the risk to capital, should there be bad news. (Fair enough. Thank you Mathan for that deep data and analytic insight!)
Having now gone through the result in detail, it was a simple story: Illuccix actually growing slightly faster in the half that you might have expected, meaning that 2H is undemanding to get to where the analyst consensus is forecasting, which is well ahead of the market. With H/H revenue growth of 28% and 29% in the last two periods, requiring only 10% in the next period is very undemanding. Given the new centres adopting the technology in the US and those yet to adopt, momentum in the US alone makes that likely. EU approval probably driveds the trajectory for longer, although I understand there is quite high adoption in the EU ahead of approval.
I'm not sure what to make of the alleged TAM expansion from $2.4bn to $3.3bn - I'm always wary of TAM expansions being touted in results presentations, so I probably need to see if I can track down the sources. (I'm new to this management team, but there seems to be a bit of promotional fluff in their delivery, which always irks me, and puts me on my guard.) That said, if the TAM expansion is real, then that bodes well for a continued trajectory for Illuccix, and FY guidance should be roundly beaten!
A key development in the result was pinning down the date for the resubmission to FDA of the BLA for TLX250-CDx, which is now planned for Q4 2024. (I'm hoping it means they have a good handle on the underlying issue!) As far as I can tell, this product doesn't have priority review status, so the FDA could take anywhere from 6-10 months to do the review. However, if it is a simple matter of giving assurance of microbial control in manufacturing, then a decision could be fast, depending on work load and priorities within the relevant teams in the FDA.
I value $TLX on just the 3 diagnostic products, which have a lower risk pathway to approval. This then gives me an option to the large upside of the therapies. My thesis is that even if TLX fail to deliver any of their therapies, the platform could over time be developed for a very wide range of diagnostics, and this on its own could lead to a very sustainable, material business. We got a bit in insight into that on the call in the discussion around Pixclara. With the manufacturing and supply chain largely established, incremental products have even more favourable economics.
Because $TLX always separately announces significant developments as they occur, I found it odd that the SP pulled back yesterday. It was as if the market expected something that was missing. A modest revenue beat was all they were ever going to get IMO. The revenue and profit was a "beat" and all the milestones remain intact (no sliding I could detect).
So I added a further 50% to my small holding on the SP weakness yesterday as I indicated I would (thank you Mr/Ms Market) taking it to a cautious 3% in RL, as I'd like a little more exposure to the upcoming milestones. Key milestones in diagnostics for me over the next 6 months are:
On theranostics, I think the next significant milestone is the STARLITE-2 TLX-250+immunotherapy Phase 2 readout.
Disc: Held in RL and SM