Radiopharmaceutical firm $TLX announced its 2Q FY25 revenues after the market's close today.

ASX Announcement

Their Headlines

• Q2 2025 unaudited group revenue of approximately $204 million, up 63% year-over-year.

• FY 2025 revenue guidance of $770 million to $800 million is reaffirmed.

• Gozellix® launched in the U.S. and commercial dose deliveries commenced.

• Gozellix has been assigned a Level II HCPCS code1 (effective 1 October 2025), a prerequisite for receiving Transitional Pass-Through payment status.

• ProstACT™ Global Phase 3 trial milestone – all 30 patients consented for Part 1. Global expansion with regulatory approvals to expand the trial into China, Japan and Canada. 

My Assessment

Revenue Growth

This is an OK result, with the %PCP comparison being the highest percentage growth since they regularly started reporting quarterly revenues. However, it is important to note that Q1 and Q2 include significant contributions from the RLS acquisition. Fortuntely, they've been helpful in breaking out the Global Illuccix revenue, where %PCP growth continues to mature - standing now at +25% to pcp and only +2% q-o-q.

As Illucix matures in the US, we will hopefully start to see sales in the EU/UK kick in. Each month, new local approvals are being granted (following the EU-wide approval in Jan-25). Each local approval kick starts the process to negotiate reimbursements. Depending on the country, this process can take anything form 0-3 months at the short end (Germany, Scandinavia), 6-12 months (UK, Fr) right up to 16-20 months (Sp, Poland) and everywhere in between.

So, over the rest of 2025 and into 2026, we should start to see EU/UK sales supporting a maturing US. Then there are the other international markets after that (Brazil, China etc,).

Of course, if $TLX achieves any label expansions for Illucix (as are being pursued) then this could support further US growth.

Important to note that Gozellix is essentially a longer half-life version of Illucix, and while it will expand geographical reach beyond each radiopharmacy preparation site's 2-hour hinterland, this should be expected to cannibalise some Illucix demand. So, in future periods as Gozellix sales start to become significant, I'll be viewing Illucix/Gozellix as a pair - and perhaps they'll even report it that way.

With now $390m of revenue booked for FY25, and revenue still growing quarter by quarter, it would seem to me that FY revenue towards the upper end of guidance (or possibly even a minor "beat") is in prospect. This will in part depend on how much of the initial sales of Gozellix are incremental to Illucix, as well as whether there is any revenue progress in territories outside the US.

Sustained 2% quarterly revenue growth would see a result of $810m achieved.

Development Program

There appears to be steady progress across the large development pipeline.

Of course, the negative outcome for Pixclara was the key disappointment of the year, and $TLX report they had a "successful Type A" meeting with the FDA on resubmission of the NDA for this drug. It will be interesting to hear if any further detail on this if given in the HY Results presentation. Analysts will almost certainly be pressing for more insights in the Q&A, as "successful" does really tell us anything, other than the meeting happened and $TLX still believe there is a pathway to approval eventually.

The next key dates to mark in the diary (apart from HY results) is the scheduled PDUFA for the Zircaix BLA expected on 27 August, 2025.

SEC Investigation

$TLX have given a high level disclosure that they are under investigation in the US by the SEC "seeking various documents and information primarily relating to the Company’s disclosures regarding the development of the Company’s prostate cancer therapeutic candidates."

While not a routine thing, such investigations are not uncommon, nor should they be surprising. The complexity of information around drug development (particularly in treating complex conditions like cancer) and the volume and timing of newsflows, makes this an extremely tough process to manage, Anyone can tip of the SEC. A disgruntled employee, investor, a competitor or someone in a partner organisation.

Importantly, $TLX have stated that "the information requested does not extend to Telix’s commercial and late-stage precision medicine products including Illuccix, Gozellix, Zircaix, Pixclara and Scintimun®." That is a really important statement and I think it will mean we don't see a significant market reaction. (Or if we do, that could be a buying opportunity!!) 

One to keep an eye on,

My Key Takeaways

Basically, a solid and unsurprising update, from my perspective. Good to see confirmation of my earlier view that we could see a "beat" on FY revenue.

Disc: Held in RL (5.3%) and SM