Radiopharma company $TLX announced its 3Q revenue numbers today, and upgraded FY Revenue guidance form US$770-$800m to US$800-$820m,

ASX Announcement

Their Highlights

• Q3 2025 unaudited group revenue of approximately $206 million, up 53% year-over-year.

• FY 2025 revenue guidance increased to $800 million to $820 million .

• Gozellix® now fully reimbursed by Centers for Medicare and Medicaid Services (CMS): Level II HCPCS code and Transitional Pass-Through (TPT) payment status effective 1 October 2025 .

• Illuccix® now approved in 19 European markets4 and the United Kingdom (UK); commercial launch has commenced in the UK, Germany, France, Finland, Sweden, Norway and Denmark.

• First patients dosed in the BiPASS™ trial of MRI + PSMA-PET5 for the diagnosis and detection of prostate cancer.

• ProstACT® Global Phase 3 trial – Part 2 open for enrollment in Australia, New Zealand and Canada and study approved to commence in China, Singapore, Türkiye and Japan. Part 1 preliminary readout of safety profile and dosimetry to follow completion of patient monitoring and data analysis.

My Assessment

I have commented earlier in the year that I considered the original guidance to be on the soft side, so today's upgrade was no a surprise to me. However, with the SP up 15% at time of writing, the market has clearly taken a different view. Fair enough, what do I know.

Although Illuccix is clearly maturing (see table above), changes across the board in radiopharmaceuticals for protate cancer diagnosis reimbursement and pricing pass-throughs appear to have been net neutral to $TLX (or perhaos mildly positive compared to some fears).

This result is afterall still dominated by US Illuccix sales, as Gosellix is early on the scene, and sales in other jurisdictions are still in their first year. (I wonder if management will be obliging and provide some futher breakout in the FY figures, when we get these early in the new year?)

Overall a positive report. (Oviously!)

Perhaps the SP recovery today is recognition by the market that the accumulated negative moves on Zircaix and Pixclara approval failures, and pricing/compeition uncertainty for Illuccix have just gone too far in the negative direction. That's the only reason I can see for the price action.

Anyway, it is of no concequence for me, as I am a Hold and retain my view on valuation significantly further north of today's corrected value.

Disc: Held in RL and SM

$TLX announce that they've agreed the resubmission package for Pixclara, rejected earlier this year, and that the FDA has indicated an expedited review is "likely".

ASX Announcement

My Assessment

Following a string of bad news, this is a mild positive for $TLX, and indicates that Pixclara still has a chance.

When NDA's fail at the final hurdle on efficacy grounds, only 1 in 3 to 1 in 4 go on to be ultimately approved (according to my BA), but the chances of success rise to around 50% is following a Type A meeting where there is agreeement between the proponent and the FDA on the resubmission package.

That the company plans to resubmit in Q4 indicates that they already have the required additional supporting data.

The market opportunity for Pixclara is not all that large, with the US market for glioma imaging estimated to be in the range $100-$140m, with imaging of broader brain oncology conditions US$475-665m (note: there would need to be further studies to support these indications, and I imagine $TLX won't contemplate these if they can't get the first approval over the line.)

I am actually more interested in what the path forward for Pixclara tells us about $TLX's ability to navigate the regulatory process. With Pixclara, they clearly submitted material that was not approved even though it appears they had "other options" available to them. While obviously, the rejection raises a question-mark over the product efficacy, it also raises in my mind a question about the capability of the $TLX team to submit an adequate package.

Learning from this will be vital for the much bigger potential imaging agent Zircaix, more recently rejected and for which the Type A meeting is yet to be announced. Of course, with the Zircaix rejection, this wasn't about efficacy, but instead about chemisty, manufacturing and controls. However, the point remains, does $TLX have a team that can respond effectively to $FDA feedback and put together a package than can be approved? We shall see.

Disc: Held in RL and SM

ASX ANNOUNCEMENT

Telix Provides Regulatory Update on TLX250-CDx

Melbourne (Australia) and Indianapolis, IN (U.S.) – 28 August 2025. Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that it has received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) for the Biologics License Application (BLA) for TLX250-CDx (Zircaix®1, 89Zr-DFO-girentuximab), an investigational PET2 agent for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma (ccRCC).

The CRL identifies deficiencies relating to the Chemistry, Manufacturing, and Controls (CMC) package. The FDA has requested additional data to establish comparability between the drug product used in the ZIRCON Phase 3 clinical trial and the scaled-up manufacturing process intended for commercial use. Additionally, the FDA has documented notices of deficiency (Form 483) issued to two third-party manufacturing and supply chain partners that will require remediation prior to resubmission.

Telix believes these concerns are readily addressable and submission remediation will begin immediately. The Company will request a Type A meeting with the FDA as soon as practicable to address the deficiencies and determine an appropriate timeframe for resubmission. TLX250-CDx has a Breakthrough Therapy designation and Priority Review status, acknowledging its importance in addressing a significant unmet medical need and clinically demonstrating benefit over available diagnostics.

Dr. Christian Behrenbruch, Managing Director and Group CEO, said, “TLX250-CDx breaks new ground as a highly novel biologic-based PET imaging agent using a first-in-class isotope. Like many radiopharmaceuticals, it has a complex supply chain, and as the field advances this creates new challenges around the regulatory framework applied to these products. We believe the outstanding matters are resolvable and that we can address the remaining FDA requests within a reasonable time frame.”

The CRL does not impact Telix’s stated revenue guidance for 20253, as guidance excludes revenue forecasts from unapproved products. The Company intends to continue to provide patient access to TLX250-CDx through the FDA-approved expanded access program (EAP), subject to consultation with the FDA.

Radiopharma company $TLX has announced FDA approval of its next generation Prostate Cancer imaging agent Gozellix (TLX007-CDx), addiing to its existing PSMA-PET imaging agent Illucix.

Gozellix is the first of two FDA decisions expected in 1H FY25 ($TLX reports over a Jan-Dec cycle).

With narrower indications than Illucix, Gozellix has the advantage of a 6 hours versus 4 hours shelf life, which means clinicians/patients further outside the current radiopharmacy footprint will have access to the product, and the second product will give the radiologists/oncologist more options. Over time, we'll also learn if the product offers any imaging/detection advantages and, there is always the potential for broadening indications over time.

As expected, the market response to this one is very modest (+ 0.2% to +1% at time of writing), as I imagine incremental sales will be modest, and $TLX have never (as far as I know) said anything about the incremental opportunity of Gozellix.

Overall, this marks a good start to the year for $TLX. To recap we've recently seen (and I'm ignoring the manufacturing/supply chain newsflow and acquisitions to broaden the development product portfolio ):

• EU Approval for Illucix (17-Jan)
• UK Approval for Illicix (12-Feb)
• FDA accepts BLA and grants priority review for Zircaix (26-Feb)
• Brazil Approval for Illucix (18-Mar)

In addition, I noticed on LinkedIn that the Netherlands has now approved Illucix, which is only 2-months after the overall EU approval. Netherlands tends to be one of the faster jurisdictions to approve after the overall EU approval is granted, however, this speed bodes well for Illucix sales getting going in Europe to give some impetus to what will be maturing sales growth in the US through 2025.

So, overall, $TLX making good progress on their 2025 milestones:

My c.2% RL position has now grown to 3.3%, and I am sitting here scatching my head wondering if I went too light on this one, coming late to the party, as I often do.

I am tempted to add, however, I will stick to my decision to wait for an opportunity closer to $26 than today's $28. Of course, there is always the risk that I am being too cute here. For example, we could soon see a positive decision on Pixclara, with the risk that SP get's over-excited (given the smaller TAM opened up by Pixclara). Equally, a failure or complication around Pixclara might see an outsized negative negative. Time to war game this using some decision trees! (FYI my valuation of $30 ($25 - $40) is not materially changed by today's announcement.

Bottom line: good to see $TLX becoming a multi-product company, and continuing to deliver positively on its 2025 milestones.

Disc: Held in RL and SM