TELIX CONTINUES TO ACQUIRE COMPLIMENTARY BUSSINESSES:

Executive Summary: ARTMS Inc. acquisition:

Significant advancement in our vertical integration of manufacturing and supply chain.

Four main areas of commercial synergy.

Improved reliability and greater control over supply chain of commercially useful cyclotron-produced diagnostic radionuclides such as 99mTc and 64Cu Development of “next generation” cyclotron targets to support the safe and high-yield production of therapeutic radionuclides Enhanced production capacity of Zirconium.

Support the roll-out of Zircaix® (TLX250-CDx) Enabling large-scale production of 68Ga to support demand for Illuccix® and next-generation product offering.

Commercial-stage radioisotope production technology firm, focus on radio-metals.

Spin-out from TRIUMF, a leading particle accelerated lab.

Deal terms1 : US$42.5m Telix shares (upfront) US$15.0m cash (upfront)

Up to US$24.5m in contingent future earn out payments (cash), subject to achievement of milestones.

TLX aquires pivately held business in what they describe as "highly synergistic" "commercial-stage company", which provides radiochemistry and bioconjugation development and contract manufacturing services to many companies in the radiopharmaceutical industry, including Telix. 

Telix Expands U.S. Development and Manufacturing Infrastructure with Acquisition of IsoTherapeutics.

Just like clockwork Telix falls on release of FY23 results

2023 highlights

• Total Group revenue of $502.5M, an increase of 214% from $160.1M in 2022 primarily driven by continued strong growth in sales of Illuccix® in the second year since commercial launch (April 2022)

• Delivered positive adjusted earnings before interest, tax, depreciation, and amortisation (adjusted EBITDA) of $58.4M an increase of $126.2M, compared to a loss of $67.8M in 2022

• Inaugural full year profit of $5.2M after tax. A substantial improvement on the net loss after tax of $104.1M in 2022

• Investment in research and development (R&D) and selling, general and administration (SG&A) reflects progress across the late-stage pipeline and scale-up of the commercial organisation

• Overall operating costs as a percentage of revenue have reduced to 52% from 105% in 2022

• Gross margin has improved to 63% (vs. 59% in 2022) reflecting distribution and manufacturing costs optimisation

• Positive operating cash inflow in line with commercial sales growth, demonstrated through customer receipts of $463.7M (vs. $124.1M in 2022), and

• Closing cash balance was $123.2M as at 31 December 2023and further differentiates Telix as a fully integrated global radiopharmaceutical company.”

Further details on the Company’s results can be found in the Appendix 4E, the accompanying investor presentation, and 

2023 Annual Report lodged with the ASX and also available on the Company’s website.

Guidance

Full year revenue for 2024 expected range of US$445M to US$465M ($675M to $705M at current exchange rates), representing an approximate 35-40% increase on 2023

Also no mention of Illucix approval for Brazil

Not sure what consensus was as I haven't been following Telix lately

Still get the feeling Telix is still running to stand still. Tempting to buy back what I sold.

(Not held)

I think UBS is the only major investment bank covering Telix - FWIW the summary from the front page of their latest update

DISC: Held in RL & SM

Telix Plans U.S. Registered Public Offering and Listing

Melbourne (Australia) – 5 January 2024. Telix Pharmaceuticals Limited (ASX:TLX, “Telix” or the “Company”) today announces that it is considering an initial public offering (“IPO”) of American Depositary Shares (“ADSs”) representing its ordinary shares in the United States (“U.S.”) and listing on the Nasdaq Global Market (“Nasdaq”). Telix’s ordinary shares will remain listed on the Australian Securities Exchange

The number of ADSs that may be offered, the number of underlying ordinary shares that may be issued, the price for such instruments and the timing of the offering have not yet been finalized. A registration statement relating to Telix’s ADSs to be sold in the proposed offering is expected to be filed with the U.S. Securities and Exchange Commission (“SEC”), any securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective which is subject to a U.S. SEC review process, market conditions, investor demand and customary corporate approvals. No final decision has been made in respect of the offering or Nasdaq listing and there can be no assurance as to the occurrence, timing, pricing and/or completion of such an offering or listing

This disclosure does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the U.S. Securities Act of 1933, as amended (“Securities Act”). This announcement is being issued in accordance with Rule 135 under the Securities Act. 

DISC: Held in RL & SM

Guess we will expect an ASX price query on Monday. Down 10% from 10.47

If there was bad news on any of these we should have halted:

* EU / UK approvals (still waiting than 15 months)

* Brazil approvals

* Progress on other trials

* Nuclear medicine supply chain issues ???

Apart from that, I didn't see anything from the brokers as well last night. Nothing really changed in the last 24 hours.

Behaving like a small cap right now rather than a safe biotech, except going the wrong way.

[held]

Telix has stopped posting announcements on some trial developments including TLX250-CDX. So need to go to their website and find out

https://telixpharma.com/news-views/

Appears that TLX250-CDX imaging agent for Renal Cancer has been added into the EAP (Expanded Access Programme) but this is after completing Phase III ZIRCON study (would have been better if it was earlier than later).

Still yet to hear about FDA approval on TLX250.

[held]

Recording of the Telix Prosact Expert Forum

ttps://event.choruscall.com/mediaframe/webcast.html?webcastid=9PnyQ7Vh

I suppose this was done to clear up confusion about the efficacy of TLX-591.

Some of the key differentiators highlighted versus other products:

1. Less or no side effects than other products such as dry-eye, back pain etc.
2. Less dosage required and shorter treatment duration
3. Better survival rates
4. Reduced radiation and costs

So while TLX-591 cancer reduction was less than Pluvicto, the lower dosage and radiation did translate to better quality of life overall for the patient.

[held]

I couldn't see an ASX announcement or similar for this but ...

Telix strikes deal to distribute cancer imaging agent in the Nordics 

An Australian manufacturer of a prostate cancer imaging agent has struck a deal with Danish company Wiik Pharma to distribute the product across the Nordics. Melbourne-based Telix Pharmaceuticals announced the deal for the distribution of the product, named Illuccix, which will see Wiik Pharma as its sole trader across Denmark, Finland, Norway and Sweden for a period of three years from the national approval date in each country. In 2020, prostate cancer was one of the most frequently diagnosed forms of cancer in the Nordic region, with that year alone seeing approximately 27,000 new cases

Yacoub Amin, CEO of Wiik Pharma said, "This commercial partnership with Telix marks a major step towards achieving Wiik Pharma's vision to improve the diagnosis and treatment management of patients with difficult-to-detect and treatment-requiring diseases. "We have high expectations for the collaboration with Telix, not just for Illuccix but also for other upcoming diagnostics and therapeutics in their investigational pipeline." GlobalData's Medical Device Intelligence Centre shows that Telix currently has two other products in its pipeline in the indication of prostate cancer, with Illuccix itself currently marketed for tumour detection in five countries, including Australia. At the same time, a report from GlobalData's Pharmaceutical Intelligence Centre details how in 2018 the European market for prostate cancer stood at around $2bn, with that figure forecasted to grow to $4.3bn by the end of 2028. In August of this year, Telix dosed the first patient in China as part of its Phase III registration trial of Illuccix, and the firm said it is cooperating with regional partner Grand Pharmaceutical Group. Raphaël Ortiz, Telix CEO for Europe, the Middle East and Africa added: "We are pleased to team up with Wiik Pharma and look forward to bringing gallium-based PSMA-PET imaging to men in need in the Nordics, an important region for Telix" 

DISC: Held in RL & SM

ASX200 Biotechs just couldn't catch a break

Latest victim is Telix, Down 10% today (19-oct) and at one stage down 15%

I think expenses went up more than expected. Revenue was slightly less than my estimate.

Not sure if they will make the 500m target. Will be tough.

Would have been good buy down to 8.50 but maybe this could go lower?

Interesting that compatriot CU6 has held well through the volatility.

[held]

FWIW UBS have published a short note on Telix Pharmaceuticals today

Potential further upside for Illuccix

12mo rPFS for Novartis's Pluvicto in PSMAfore could drive further Illuccix sales

The abstract for Novartis's Pluvicto in pre-taxane metastatic prostate cancer patients to be presented at ESMO has been released. Full data will be presented on 23rd October (LBA 13). In the phase III PSMAfore trial, Pluvicto delivered median rPFS of 12 months (HR 0.41, 95% confidence interval 0.29-0.56, p<0.0001), meeting the bar our physician feedback had suggested would be perceived as a good result, given chemo achieves 8-9mo (the trial is not head to head)

This matters for Telix because the company's prostate cancer diagnostic for PSMA+ disease, Illuccix, is labelled for selecting patients for Pluvicto use. Our existing estimates include some use for this, given it was already known that PSMAfore had read out positively and later line use (VISION trial setting) is becoming well established

Together with the other use cases, these existing estimates imply Illuccix is worth c.AUD12 per share. We have not changed anything for now, but we see the potential for some incremental further upside given what appears to be robust PFS. The full data presentation will matter - overall survival is confounded by crossover, so physician intention to use will help inform how we see this patient group's ability to drive revenue at Telix going forward. Telix's 4C is due later today AEDT

DISC: Held in RL & SM

USB First Read for TLX

No real updates at this stage...

1H23: No major surprises, progress continues

Key metrics (Illuccix revenue) pre-released, underlying operating expenses not far from expectations, major projects look to remain on course

We value Telix shares using an NPV SOTP and have not changed our estimates with this update (Buy, 12m PT $14)

Will see if UBS release a full update report with anything interesting in the next day

DISC: Held in RL & SM

UBS initiated coverage of TLX (on 22nd May 2023) as a Buy with a 12m price target of $14 - their full research report is 50 pages long - the following is some of their front page summary - I think UBS may be the first major investment bank to cover TLX

Initiation of coverage: Near-term assets not fully priced in. Buy.

Illuccix growing and TLX250-CDx remains underappreciated

We initiate coverage of Telix with an AUD14.00 Price Target and a Buy rating. Telix has launched its first major product - a radiodiagnostic, Illuccix, for prostate cancer, in the US and sales are annualising at c.AUD400m. There is competition but Telix is taking share in a market we think can reach USD2b. Our SOTP suggests the share price bakes in cAUD1.3b of global peak sales vs our forecast at c.AUD1.8b. Another diagnostic, TLX250-CDx for RCC (kidney cancer), should launch in 2024 and we see AUD240m peak sales, but it looks largely outside the share price. There are questions to resolve on the therapeutic pipeline but these are unlikely to drive the shares in 2023 in our view. Biotechs reaching profitability are fairly rare and we see positive EPS for Telix this year.

Bigger than expected market for Illuccix, warm reception for TLX250-CDx data

Radiolabelled agents targeting the PSMA protein (Illuccix, Lantheus' Pylarify and Novartis' Locametz) have been welcomed in the prostate cancer field - more patients are receiving more scans. Telix estimates USD1.5b total market size and we can see USD2b+ in time. We think robust volume expansion on the way to these markers can drive sustained revenue growth even with a likely large price cut in the US Medicare channel in 2025 (we forecast total list to net discount of -51% after the event vs -18% before). Physician feedback on TLX250-CDx's phase III ZIRCON data is positive and we think appreciation of this asset will grow as US submission becomes imminent in mid-2023.

Conviction in the therapeutic pipeline not needed to own the shares in 2023

Telix has a pipeline of therapeutic assets. If these turn out to be commercially meaningful, we think upside could be substantial given price differentials vs diagnostics and the company would look different from others in the radiopharma space. The most advanced projects are TLX591 (prostate cancer) and TLX250 (RCC). Both aim at competitive areas, so clinical niche matters and we think efficacy data at the chosen doses are needed for investors to assign value. The 2023 investment case lies elsewhere but we could see: 1) phase I data for TLX591 at the phase III dose from ProstACT SELECT and 2) clarity on the TLX250 strategy. We are aligned with the view that more information is required and include only placeholder sales for now in our valuation.

Valuation: NPV SOTP- derived Price Target of AUD14.00 per share

We forecast cash flows for each of the assets that we think can offer value (WACC 9.9%). Illuccix makes up 85% of our valuation, TLX250 makes up 10%, cash / early stage assets form the remainder. 

DISC: Small position held in RL & SM

Telix sudden fall was due to downgrades across the board

I'm still doing my own figures

Anyone got ideas on how to covert Operating Cash from activities in the quarterly to Ebitda? Feel free to share.

[held]

In todays AFR is their Fast Global List Special Report (The Fast Global list ranks the Australian companies most quickly growing their revenue sourced from offshore)

Anyway TLX topped the list

https://www.afr.com/work-and-careers/management/why-this-ceo-thinks-454pc-growth-in-his-company-is-just-the-beginning-20230526-p5dbih

For those outside the paywall...

Telix Pharmaceuticals has topped the inaugural Financial Review Fast Global list, with international revenue growth at the Melbourne-based, cancer-fighting biotech soaring off the back of a drug approval in the US.

The Fast Global list, which is presented in association with Quadrant Private Equity, ranks the Australian companies most quickly growing their revenue sourced from offshore.

From $5.2 million of sales outside Australia in 2019-20 and $7.6 million in 2020-21, Telix suddenly shot up to $160 million of offshore sales in 2021-22, representing a 454 per cent compound annual growth rate over the past three financial years – the metric on which the Fast Global list is ranked.

Listed on the ASX with a market capitalisation approaching $4 billion as at June, Telix topped the list ahead of insurance technology conglomerate POP International Holdings, which grew offshore revenue to $12.5 million at a 268 per cent clip over the past three years. Third was Espresso Displays, a maker of portable screens for the work-from-home era, which took in $5 million in 2021-22, a 255 per cent increase on 2019-20.

The massive revenue surge at Telix was not the result of a major acquisition – which would disqualify it under list rules which stipulate the majority of revenue growth must be organic – but of winning approval from the US Food and Drug Administration for Illuccix, its screening tool for prostate cancer.

“Illuccix is changing the lives of about 2000 patients globally every week,” says Christian Behrenbruch, a biomedical engineer who co-founded Telix in 2015.

“You’d be surprised at how many letters we get telling us what our product has meant to them.”

Illuccix represents the first commercialisation of Telix’s core technology that develops molecules capable of carrying a radioactive particle, which can be infused intravenously and spread naturally throughout the body.

At lower dosages of radioactivity, these molecules can then be used to detect cancerous cells and at higher doses can be used to kill them. Another diagnostic product is imminent, this time detecting renal cancer, but Behrenbruch hopes Telix’s therapeutic products capable of destroying cancer are no more than two or three years away.

Telix’s technology has emerged as an alternative to other oncology drugs, which seek to target a particular cancer’s signalling pathway or shut it down biologically. They are also an alternative to standard radiation oncology, which involves patients lying down inside a linear accelerator machine – usually in the basement of a hospital -– and having X-ray beams shot at the known cancerous cells inside them.

“That has been working well for a century, but the main limitation of that approach is you can only treat what you can see or what you can localise, and it causes a fair bit of collateral damage,” Behrenbruch says.

“Our molecularly driven radiation is much more targeted and precise – no matter where in your body you have cancer cells, we’re going to hit them.”

‘Exquisite pictures’

For diagnostic products like Illuccix, its injectable molecules act as a radioactive beacon throughout the body, which under a standard scan from a positron emission tomography machine, will provide what Behrenbruch calls “exquisite pictures” of anywhere a particular cancer’s signature is present.

In the past, many prostate cancer patients have been put on to hormone therapy as a preventative measure, particularly if their levels of prostate-specific antigen are found to be rising after they’ve already had their prostate removed.

“Hormone therapy means you put on a tonne of weight, you have higher risk for all kinds of diseases and you lose your erectile function as well,” Behrenbruch says.

Illuccix, however, allows whatever “speck of disease” that escaped the prostatectomy to be found and dealt with – perhaps with localised radiation therapy – without the need for hormone therapy.

The potential benefits of applying Telix’s technology to renal cancer diagnostics are even more profound. Behrenbruch says 10,000 kidneys are removed unnecessarily every year in the US alone because of a failure to diagnose and stage the treatment of patients correctly.

Despite 80 per cent of Telix’s 300 staff now based outside Australia – most of them at its research hub in Indianapolis – and more than 90 per cent of its revenue also being garnered offshore, Behrenbruch says Telix will remain an Australian-domiciled company.

He cites several reasons for this, including Australia’s research and development tax incentive scheme and the country’s ready supply of the medical isotopes which Telix needs to make its products, thanks to the work of the Australian Nuclear Science and Technology Organisation.

“ANSTO are one of the reasons that molecular radiation took off around 2015 – the supply chain got a lot better, so conducting clinical trials got a whole lot easier,” Behrenbruch says.

Brisbane plant

If not for the pandemic, Telix would have manufactured Illuccix in Australia, however the inability of the FDA to inspect an overseas facility at the time made Indianapolis a more favourable option. However, the renal diagnosis tool, for which Telix has just completed phase 3 trials, will be made in Brisbane.

Apart from the favourable infrastructure, another swing factor for keeping Telix in Australia is its investor community familiarity with molecular radiation. Behrenbruch says early on Telix was far better understood here than in the US, thanks to the precedent set by ASX-listed Sirtex, which attacks liver cancer with tiny radioactive beads called microspheres.

Look out for Telix to remain a fixture of the Fast Global list for some years to come. Already a very rare biotech company that is cashflow positive, the market for Illuccix is set to further expand with approvals pending in China and Japan, but then the eventual addition of cancer therapies promises a step-change in growth.

Last week, it opened a $21 million nuclear medicine facility in Belgium, creating a springboard to crack the European market as it dashes for global growth.

Telix’s $50 million initial public offering in 2017 was the biggest for an Australian biotech since that of CSL and Behrenbruch dares to use the blood plasma giant with a $144 billion market cap as a benchmark for his aspirations.

“CSL is proof that the talent and the clinical resources we have access to here in Melbourne is phenomenal,” he says.

“CSL is obviously a rare company, but I think it’s possible to start another one”

DISCL: Held in SM & RL

Received this in my inbox from Ausbiz.

Doesn't look like director selling to me?

The Appenidix 3Y was for Performance rights, not a disposal. Someone not doing the fact checking properly at Ausbiz.

Instead I suspect the news on Blue Earth partnering with Siemens on their approved PSMA agent has finally caught up with Telix.

[held]

New competitor Blue Earth enters market.

Explains why Telix and Alzheimer imaging hopeful Lantheus share price nosedived on Monday/Friday.

I don't know enough about Posluma so can't comment.

Commentary below from StreetAccount.

FDA approves Blue Earth's Posluma, F18 PET diagnostic of PSMA for prostate cancer

According to FDA.gov, the agency on 25-May approved Blue Earth Diagnostics' NDA for Posluma (flotufolastat F18) injection for positron emission tomography (PET) of PSMA positive lesions in men with prostate cancer with suspected metastatsis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

StreetAccount notes that Blue Earth Diagnostics is a Bracco Company (private). Tickers included for PSMA-targeted PET diagnostics. SVB Securities analyst Roanna Ruiz (outperform LNTH, PT $127) recently discussed the potential competitor to Pylarify, and expected FDA action on Blue Earth's NDA in "late July / early August at the earliest". On Lantheus' Q4 earnings call, CEO was asked about competitors entering the market this year:

"I'm sure you're referring to the Blue Earth F 18 product that may come into the market later this year just based on general regulatory timelines. We would look forward to having another player in the market. As I said, in those markets, however we view it and we view it many different ways because we intend to be very prepared for anything that happens in our market, we intend to remain as the commanding leader with PYLARIFY in that market."

Hmmm

[held]

The news about Lantheus beating consensus guidance recently to become the leading provider of radiopharmaceuticals prompted me to write another straw on Telix and its closest competitor even though I wanted to avoid it and look at something else.

In summary, Telix has a lot of ground to cover despite doing lots of work laying down the foundations.

However, I recall Christian said in one earnings call their high priority market was the EU and so they are on the back foot in North America.

Going through their website and past slides, it appears that Lantheus has a slightly different pipeline to Telix with exception to PSMA imaging and therapy. These include neuro-endocrine tumours and imaging for cardiology (myocardial perfusion). Also they have a product called Definitiv which is an agent that enhances sensitivity of echocardiograms (so to speak).

There's no mention about Renal Cancer which Telix is also working on.

In addition, Lantheus is working on a imaging agent for Alzheimers disease called MK-6240. Could this be a compliment or a concern for Cogstate?

Pretty solid board and they communicate clearly throughout the call

Lantheus has lots of irons in the fire and a real "Jack of all trades" with proven revenue numbers.

Could explain the weakness in Telix and, to some extent, Cogstate in the last few days.

[Held Telix and Cogstate but not Lantheus (I wish!)]

Only a Non exec director so not an insider and I don't consider significant,

But the on-market trade by Tiffany Olson was quite big.

[held]

Murdoch 0 - Telix 1??? (see my previous straw "Misinformation")

Telix stages a comeback rally after their investor audio update.

Q4 records positive operating cash flow of $1.6M

Gross margin improvement of 2% from Q3 (61%) to Q4 (63%)

Probably the most interesting slide, the differentiation between TLX-591 and Novartis' Pluvicto. Chris highlighted it will take around 18 months of development.

Conference audio

https://telixpharma.com/wp-content/uploads/2023/01/Telix-Pharmceuticals-Limited-Q4-2022-Financial-Results-Presentation-and-Shareholder-Update-10028150-180123.mp3

[held - catching the Murdoch knife hopefully was worth it]

Couple of Murdoch mastheads the Herald Sun / The Australian has been circulating that Telix did not meet analyst revenue forecasts which is misleading

https://www.heraldsun.com.au/business/telix-us-sales-soar-39pc-on-prostate-cancer-scan/news-story/169fa7c216df58f792787ae11e3b5dd1

https://www.theaustralian.com.au/business/telix-us-sales-soar-39pc-on-prostate-cancer-scan/news-story/169fa7c216df58f792787ae11e3b5dd1

Not sure if this was the cause of the falling share price.

I sent an email to the Herald Sun/The Australian about this to confirm their sources of the estimates (like which broker and the analyst name plus an interview). Haven't heard back obviously which is pretty bad journalism on their part not surprising.

This is the info from Factset confirming they met the rev forecasts (74.68 vs est 71.0)

Needless to say I won't be subscribing to "The Australian" any time soon...

[held]

@edgescape it looks like a risky but potentially high reward tradeoff for Telix. From what I understand from the press release olaratumab does not work as a therapeutic/treatment agent in the trials it has been used so far. However it has high specificity for targeting certain types of cancers (they think). Telix is planning to use this specificity to diagnose soft tissue sarcomas and provide more targeted radiation as they apparently are more radiation sensitive. There may be the possibiltity of combining it as a part diagnostic and part therapeutic drug, but I imagine this is what the 'further development' part means.

My takeaway is this is very early stage pre-clinical theoretical research. I imagine they had to pay out a lot of money as if they succeed they will likely be able to charge a very large amount for their repurposed olaratumab. Rare cancer treatment is often hundreds of times more expensive than 'standard' therapy. So either they are very confident or over-confident, not sure which!

Full disclosure I own shares IRL but see it as a very risky investment and am hanging in for the long haul.

Looks like a large bunch of options got excised and dumped on the market, hence the large percentage drop.

Also some news came out of Novartis about FDA approval of a competing drug to treat prostate cancer called Pluvicto.. So this may have contributed although not sure given the price of the Novartis drug is $42500 a dose.

https://www.healthcaredive.com/news/novartis-fda-approval-pluvicto-prostate-cancer-endocyte/620984/

May need to revise the price targets as they may be more options hidden away.

Held

Telix and Kanazawa University Cleared to Commence Prostate Cancer Imaging Study in Japan

Melbourne (Australia) and Kyoto (Japan) – 22nd February 2021. Telix Pharmaceuticals Limited (ASX.TLX) (‘Telix’, the ‘Company') announces today its subsidiary, Telix Pharmaceuticals Japan KK (‘Telix Japan’), in collaboration with Kanazawa University, has received Clinical Trial Notification (CTN) clearance by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to commence a Phase I trial of its prostate cancer imaging product TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11 injection) in Japan.

In December 2020, Telix Japan commenced a clinical collaboration with Kanazawa University to conduct a Phase I trial of TLX591-CDx enrolling 10 patients with advanced prostate cancer. The purpose of the trial is to obtain preliminary clinical data in a suitable patient population, confirming that the targeting and pharmacology of TLX591-CDx is equivalent to non-Japanese patients. Such clinical data will support future planning discussions with the objective of PMDA product approval in Japan, aligning with the marketing authorisations that Telix has already submitted in the US, EU, Canada and Australia.

Prof. Seigo Kinuya, Professor of Nuclear Medicine at the Kanazawa University Hospital, Department of Nuclear Medicine, Chair of the Japanese Society of Nuclear Medicine, and Chair of the National Conference for Nuclear Medicine Theranostics stated, “ 68Ga-PSMA-11 has been studied widely and intensively across the globe outside of Japan. Clinical data have been accumulated and its diagnostic efficacy and clinical application have been well characterised in guidelines in nuclear medicine and urology, worldwide. This first clinical trial of 68Ga-PSMA-11 prostate imaging in Japan is a crucial milestone to pave the way to provide new diagnostics to Japanese prostate cancer patients.”

Telix Pharmaceuticals Japan K.K. President Dr. Shintaro Nishimura added, “This study is the first formal clinical trial in Japan of a gallium labeled PET imaging agent, which many Japanese nuclear medicine and urology physicians have been waiting for. We would like to express our appreciation to our pioneering colleagues at Kanazawa University's Departments of Nuclear Medicine and Urology, the Innovative Clinical Research Center of Kanazawa University Hospital, the Kanazawa Advanced Medical Center, ATOX Co. Ltd and IRE ELiT (Belgium) for their exceptional support and collaboration in this project.”

Czech Republic Grants National Authorisation for the Use of Telix’s Prostate Cancer Imaging Product

Melbourne (Australia) and Liège (Belgium) – 16th February 2021. Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces today that the Ministry of Health of the Czech Republic is the first European health authority to grant a national authorisation allowing the use of TLX591- CDx (Kit for the preparation of 68Ga-PSMA-11), a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET). 

The national authorisation, which is specific to Telix’s prostate cancer imaging product, enables Czech physicians to use TLX591-CDx under a Specific Therapeutic Programme (STP), which allows medical products intended for the treatment, prevention or diagnosis of conditions severely affecting human health to be used prior to being granted a full European marketing authorisation.1 Telix is collaboratively pursuing such temporary approvals in a number of European countries, concurrent with marketing authorisation applications.

Under the STP authorisation, which is valid until 31st December 2022 TLX591-CDx is indicated for the diagnostic imaging of prostate cancer using PET/CT or PET/MRI for the purposes of:

        1. Primary staging of high-risk disease with a view to early identification of metastases

        2. Localisation of prostate cancer in patients with PSA progression following radical treatment2

        3. Identification of patients with extensive generalised prostate cancer for who radical life-saving treatment is not indicated

1   https://www.sukl.eu/pharmaceutical-industry/related-information

Disc: I have small holding

Telix and Heidelberg University Hospital to Develop Next Generation Theranostics

Melbourne (Australia) and Heidelberg (Germany) – 10th February 2021. Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) today announces it has concluded a research cooperation agreement with Heidelberg University Hospital in Germany (UKHD) to develop next generation theranostic radiopharmaceuticals for urologic oncology.

Under the terms of the agreement, Telix and UKHD will co-develop new conjugates and constructs for diagnostic and therapeutic (‘theranostic’) use.

The goal of the collaboration is to identify candidates and generate sufficient data to proceed to first in human (FIH) trials, with all candidates being evaluated in a pre-clinical study (in vitro and in vivo analysis, toxicology, and manufacturing suitable for clinical translation).

DISC: I hold

Telix Pursues Direct Benelux Product Distribution

Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) today announces it has elected to terminate its agreement with PI Medical Diagnostic Equipment B.V. (‘PI Medical’) for exclusive Netherlands distribution rights to TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11 injection) for prostate cancer imaging, and non-exclusive rights in the Flemish region of Belgium. 1

Over the past twelve months, Telix has invested heavily in its European footprint, including the acquisition of a radiopharmaceuticals manufacturing facility in Seneffe (Belgium) in 2020.2 The Company’s clinical team has also been significantly expanded to deliver multiple clinical studies in Europe, including the ZIRCON3 and IPAX-14 studies. Telix now has a suitable network, production infrastructure and commercial team to distribute its own products in the Netherlands, including Illuccix® (TLX591-CDx), which is anticipated to receive an EU marketing authorisation this year, subject to regulatory approvals

1 ASX disclosure 2/07/19.

2 ASX disclosure 3/04/20.

3 A Ph III study of Telix’s renal cancer diagnostic product TLX250-CDx. ClinicalTrials.Gov Identifier: NCT03849118.

4 A Ph I/II study of Telix’s glioblastoma multiforme therapeutic product TLX101. ClinicalTrials.Gov Identifier: NCT03849105.

Disc: I hold

Activity Report and Appendix 4C for Q4 2020

Financial Summary

• The Company held cash reserves of $79.09 million on 31 December 2020.

• An up-front non-refundable prepayment of $33.81 million, plus an equity investment of $35.1 million were received during the quarter following completion of a strategic licence and commercial partnership with China Grand Pharmaceutical and Healthcare Holdings Limited (CGP) for Greater China. (*1)

• Operating expenditure during the quarter included $7.93 million for R&D and clinical trial costs, as well as regulatory filing costs for Telix’s first product Illuccix® (TLX591-CDx), for the Positron Emission Tomography (PET) imaging of prostate cancer.

• Telix has sufficient capital reserves to launch its first two products Illuccix® (TLX591- CDx) and TLX250-CDx for prostate and renal cancer imaging, respectively (*2 ), and to fund ongoing clinical development costs in 2021 and 2022.(*3)

(*1)  ASX disclosure 2/11/20.

(*2)  Subject to approvals in the relevant jurisdictions. None of Telix’s products have attained a marketing authorisation in any country.

(*3)  Subject to timely commencement of revenues from product launch of Illuccix® (TLX591-CDx) in the US/EU.