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Pinned straw:

Added 3 months ago

TLX was the stock of the day on The Call on Ausbiz today (double Hold if it matters) (fyi the link is to just the stock of the day part of the segment Youtube)

mikebrisy
Added 3 months ago

@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:

  1. Pixclara NDA submission Q3 FY24
  2. Illuccix approval in 24 FY24 EU and UK (and, OK Brazil too - but its small by comparison)
  3. Zircaix BLA resubmission Q4 2024


On theranostics, I think the next significant milestone is the STARLITE-2 TLX-250+immunotherapy Phase 2 readout.

Disc: Held in RL and SM

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Remorhaz
Added 3 months ago

@mikebrisy I hadn't posted this but UBS also released a short note on friday (see below) - after the conf call I believe. It also makes comment re Clarity's copper based PSMA targeting agent (which I saw has been discussed on SM lately e.g. by you and @Nnyck777 amongst others (I'm not really following CU6 but I know others are and I also listened to that podcast with Michael Franzis as well - tho I'm not exactly a fan))

Have catalysts, have money

Following 1H results, TLX's catalyst pathway appears intact, falling into commercial / regulatory developments in the near term (Zircaix BLA resubmission, potential ex-US approvals for Illuccix (Brazil, EU), Pixclara submission) and data readouts for the therapeutic pipeline towards the end of this year and into next (TLX250 phase II data (kidney cancer), TLX101 (phase I, brain cancer (GBM) and TLX591 (phase III interim, prostate cancer)). We also expect TLX to take steps to deploy some of the net AUD635m of funds raised via recent issue of convertible bonds, probably including supply chain / infrastructure assets. We view weakness in the shares today as a buying opportunity

Which catalysts are the most important?

For long-term value creation, the clinical data readouts. Ex-US approvals for Illuccix might provoke incremental uplifts to forecasts but data for the therapeutic pipeline open doors to better appreciation of assets that are outside the share price, in our view. TLX250 looks to be heading for PD-1 refractory RCC patients - a growing pool via the advent of immunooncology earlier line. Enhancing responses to immunologically cold tumours and / or getting around T-cell exhaustion has long been a goal so we think investors will want to scrutinise the data closely but we are cautiously optimistic. We think good phase I data for TLX101 would be well received given years of searching for approaches that work in GBM. TLX591 has done some of the hard work already / is differentiated vs competition, and needs to demonstrate efficacy in phase III

We are (still) not worried about the potential for competition from Clarity

We have been asked several times in recent weeks for our view of potential competition for Illuccix from Clarity (N/C) who is developing a copper-based PSMA-targeting agent which requires 24 hours to localise for optimal imaging and potentially has the ability to discern small tumours. Our view is laid out in our note from 19th August but in short: 1) 24-hour interval from dosing to imaging is a disadvantage not an advantage vs current options at 2-3 hours, 2) No H2H trial that we know of with existing agents and existing agents at parity in NCCN guidelines, 3) Existing agents can detect small tumours too, per Novartis who had to re-plan a non-metastatic trial when scanning patients with Locametz / Illuccix made it obvious that some previously "non-metastatic" patients were actually metastatic, the difference being newly highlighted small tumours, 4) Small / late players in the market have low single digit market share. Management also reminded investors today that: 5) 64Cu has potential supply chain and use constraints 


DISC: Held in RL & SM

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mikebrisy
Added 3 months ago

@Remorhaz thank you for sharing. The analyst clearly has a deeper understanding of this diagnostic and therapy area, which is new to me and I am climbing a steep curve. So, it is encouraging to see good alignment on some of my assessments. from yesterday.

On Illuccix versus the $CU6 copper-based PSMA-targeting agent, I have landed in the following place. I cannot form a view on what $TLX are saying nor on what $CU6 are saying because of their obvious biases. Equally, I can't attach any weight to the UBS analyst, because they cover $TLX (Buy) and don't cover $CU6.

I think you'd need an independent clinical practitioner's view. I did my PhD in MRI-imaging, so I know how important enhanced contrast is on sensitivity, and I understand how important this can be in cancer diagnosis. But I can't judge how the improved contrast benefit of the longer half-life of the $CU6 product weighs with the cost of inconvenience of two visits over two days, which the $TLX product avoids. To answer this, I think you'd need to speak to a radiologist or other clinician who'd used both products in a similar patient. I think the chances of that are very low, and they are zero for me.

In the absence of proper data on this question, I have to go with speed-to-market as the differentiator. So my bias rests firmly with $TLX who are 3-5 years ahead. Of course, I remain open to new data. However, CEO advocacy or obviously biased analyst comments don't count as fact-based evidence, per se.

For sure, I am eager to read everything available on the topic!

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edgescape
Added 3 months ago

Although I like the Telix CEO sometimes he can get a bit animated.

This TLX v CU6 is turning out to be like the battleground between Microsoft and Linux!

Can't wait for the CU6 meeting in October.

Have the popcorn ready ..

9

juneauquan
Added 3 months ago

This talk of Telix vs Clarity

I have held Telix IRL for a number of years, but I am ALWAYS looking for possible disruptors to any company I own

Thus Clarity popped up. Had a look and thought, Clarity could disrupt Telix but I am not smart enough in this space to definitively judge one way or the other

So I hedged

Took a position in Clarity

My position in Telix is signifantly bigger than Clarity because they have proved themselves versus Clarity but that first mover advantage may mean squat in the long term


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edgescape
Added 3 months ago

@juneauquan

TBF the Lantheus CEO is worse

But I do see a trend that everyone in this space is talking their book and it is not nice.

Even Novartis is doing the same.

It starts becoming less science and more religion.

8

topowl
Added 3 months ago

Clarity is still just a speccy biotech.

I find it weird when people frame it like it's a sure thing..... an approved and commercialised product.....because it's simply not.

So much can go wrong on the science or commerical front and statistically, it does.

Way too risky (imo if you hadn't guessed...lol).

It's not even at a coin-flip probability of success yet.

The FDA could raise the bar, move the goalposts, change the playing field or whatever other sports analogy you want. It's a huge factor.

It's capital-intensive stuff and timelines are not concrete so lookout more capital raises.

Execution risk,  speed bumps, delays, mistakes – they all add to the burn considerably. 

For a Phase 3 stage bio-tech speccy, a 6-month delay in recruitment may necessitate more financing.

Idiosyncratic safety risk.....what if one patient has a "possibly related to drug" event? 

Rough position to be trying to explain away a weird event.....stock price halves. 

And weird things are probabilistic – more patients, increased likelihood of a weird event.

I mean even if you mistakenly think you're a guru on the product and think the science risk is low (which I think any grounded person in reality knows is impossible as an outsider.....no matter how long you've worked in the area.....)...the list of potential risks is still huge for late stage trial biotechs.

Surely big pharma must be considered more of an expert than regular punters.....wouldn't they have already bought clarity if it was indeed a sure thing......I just don't think it's that’s complicated.

Needs to be said more often.

Too risky, speculation not investing.

Good luck to Clarity though, hope they cure cancer, but until it gets final approval and commercialises successfully........I'll watch from the bleachers.

(there you have it, that's my strawman argument for the day, lol)

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edgescape
Added 3 months ago

@topowl

No offence but it feels like I'm listening to an AI bot that is slamming every mention on Clarity.

My post was more on CEOs in general talking their own book and that we should not give those comments any weight as mentioned by @mikebrisy

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