When Kidney Disease and CSL Vifor/ Dimerix is not enough ...

https://investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-new-data-highlighting-potential

Corvus Pharmaceuticals - The little engine that can....

Still watching but can't get myself to buy....

I probably should have sold CMM, not TLX

I still have lots to learn about (not) holding gold companies for too long.

Congratulations to Telix. Better than Pluvicto... just (8.8 vs 8.7 months)

I still have consolation prize CU6 which is still a long way

[not held]

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)

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]

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]

Telix reported their latest results today.

Looks good and share price up today to 10.78

Below clearly shows the positive trend and metrics

[held]

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]

Telix released their quarter update after market closed.

Revenue for June Qtr was 120.7m. Cash increase of around 10m and operating cashflows increased about 10m.

Looks like they only just met analyst forecasts from Factset (as they present the numbers better).

On a final note, Telix makes the point on jumping on the AI bandwagon just like every stock is doing nowadays.

[held]

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!)]

Telix presentation with Grand Pharma

https://vimeo.com/819362124?embedded=true&source=vimeo_logo&owner=91637993

For those that are still struggling with the value proposition, fast forward to 6:30 where the CEO explains in simple terms how the technology works although obviously there is much more going under the bonnet.

I think alot of us struggle to understand what the products such as Illucix does and still conclude this is high risk, although money is now starting to flow through.

I'm starting to understand Telix better than when I first got here under $6 so was a leap of faith at the very start especially when you get first hand evidence of a family member being diagnosed with cancer.

But I have to admit this was a real test of conviction with the CEO selling before the entry into the ASX200 (I imagine the selling was because this was to satisfy the turnover requirement to enter the 200 and get other instos on board) which usually would be a orange flag for me and prompt me to sell, the capital raise being cancelled and the EU application having to be resubmitted.

[held]

Simple quick chart I made summarising the main outflows and totals across the last three quarters. I didn't bother with March 22 since they did not start ramping up till later.

Can see the trend is still rising so that magical operational leverage is still not kicking in yet. Maybe this is viewed as a negative to some and why the share price has been stuck in the current range $6-$7 till now.

Main ones contributing to the cost is R&D and staff. Product manufacturing is starting to flatten. R&D spend is probably contributed from Telix trying to explore the different applications for their targeted radiotherapy technology on other cancer types and advancing their therapy treatments.

Interestingly many analysts also were not expecting the magic 100m to appear so soon as summarised brilliantly in the callout in Factset and explains the big movement in price today.

FYI: My last straw I should have said operational cash flow NOT operational free cash flow.

[held]

Telix ends the quarter with 100m revenue and increase in operational free cash flow from 0.8m to 2.4m.

But with so much other external developments and treatment in cancer starting to wonder how long the runway will last?

[held]

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]

ASX CEO Connect Podcast

Telix presents at 1:45-2:00

https://www.youtube.com/watch?v=cMEn5J_zJgs

Lots of points discussed particularly about revenue with a few numbers discussed.

I'm on the fence when he mentioned the 1+billion revenue in few years. So will let everyone be the judge on that.

However the price seemed to hold pretty well today - maybe the market liked the podcast.

[Held]

More of technical commentary. Ugly candle a few days ago before staging a strong turnaround.

Whoever bought the bottom wick (5.85) would be laughing. On the other side of the coin, the person who sold at the lows would not be having a good day.

Would be great if we could trade that volatility in Strawman.

Only news I could find is on the previous afternoon, Telix announced a loss which sounds bad and might have been the trigger when the market.

However the loss had narrowed and approaching a possible inflexion point

Anything under $6 seems like a buy but that is my personal view only.

[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]

Telix reports revenue for Q4 FY22 to be US 50.5m (AU 76.8)

Shares tanked 7%. Looking at the Top picks by Bell Potter, they are expecting excess of $300m for FY23. But after this result, it looks like revenue may be at lower end of expectations.

I can't think of anything else that would cause the fall in the share price. I checked the pipeline using the help of screenshots!

Think something slipped. Look at 177Lu (TLX591)....

This month:

Sept 22 business update. TLX591 was in middle of Phase 3

So good rev numbers let down by progress in therapy. I should have traded the high at 7.70.

Such is life for biotechs these days.

[held]

Interesting acquisition

Funded through cashflow. Telix must be pretty confident about the future if they can do this without another capital raising.

But as they say, don't let fundamentals get in the way of a good story. On the other hand, maybe the fundamentals are being more clearer and the billion dollar valuation does seem justified even if the revenue is tiny as highlighted by other straws?

Not investment advice obviously and this is a high risk play on a rich valuation of billion plus.

Full announcement below

[held]

Telix Acquires Optimal Tracers

Melbourne (Australia) and Indianapolis, IN (U.S.) – 14 November 2022. Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into an agreement with

Sacramento-based Northern California PET Imaging Center (NCPIC) to acquire Optimal Tracers, a radiochemistry development business providing radiochemistry process development services and research tracers for use in clinical trials.

The acquisition of Optimal Tracers will bolster Telix’s in-house radiochemistry development capability, by adding a highly skilled team to Telix and establishing a U.S.-based laboratory and production footprint for clinical trial doses. The acquisition includes a facility with a radiation and pharmaceutical manufacturing licence sufficient to cover the Company’s key diagnostic andtherapeutic isotope requirements for pre-clinical and clinical research purposes. The acquisition of Optimal Tracers aligns with Telix’s strategy to build a degree of vertical integration, improve in-house research and radiopharmaceutical development capability and further develop novel tracers in its pipeline. Optimal Tracers will also remain available as a strategic collaborative resource to partner organisations and pharma collaborators that need access to specialist radiochemistry domain knowledge.

Located in a translational research hub at the University of California, Davis (UCD), Optimal Tracers is a specialised business that provides development services and clinical trial doses to pharmaceutical and biotech companies, as well as academic research institutions. Optimal Tracers is advantageously located to service leading clinical sites along the West Coast of the United States, with capability to deliver certain research products across the entire country.

Jonathan Barlow, SVP Global Business Development & Alliance Management said, “Optimal Tracers is an established business, with a highly regarded team and impressive client roster. They have built a strong reputation based on their deep technical skills and ability to help clients optimise drug development, production processes and quality control. We are looking forward to welcoming the talented Optimal Tracers team into the Telix family - together harnessing an innovative approach to radiochemistry to further enhance Telix’s pipeline and continue support of the Optimal Tracers business.”

Ruth Tesar, CEO of NCPIC and Optimal Tracers added, “We are delighted that Optimal Tracers will become part of Telix, an established leader in the global radiopharmaceutical industry. Telix and Optimal Tracers are closely aligned in purpose and values, and I am excited about the growth opportunities this will offer our employees. We look forward to bringing our considerable depth of radiochemistry development knowledge and experience to Telix and contributing to the Company’s future success.”

Telix will fund the acquisition from operational cash flow. The purchase price is non-material and will be offset by Optimal Tracers’ service provision and manufacturing income and cost savings from bringing radiochemistry-related R&D activities in-house. Telix will have ownership of all intellectual property, physical assets and licences of Optimal Tracers

Adding further to Juneauquan's last straw.

Can agree that the valuation of 2 billion is a bit high.

Can also agree that their execution has been a bit "lumpy" with the EU setback. This may be due to lack of knowledge or resources for such a new company such as Telix. Hopefully Telix will learn but it has set them back over a year in EU giving a chance for Novartis to capitalise.

But there is no denying that cancer treatment is going to be high priority moving forward. And I think they have the right platform to take advantage of this. In addition they are looking at other cancers outside the ones mentioned in the slide below. Despite Novartis being the big gorilla in the room, I have a feeling maybe there is enough for two.

Furthermore, any cancer diagnosis is treated as a high priority case from personal experience despite Covid still lingering around.

Sorry for hyping Telix up - it is totally unacceptable for pumping a company not yet breakeven on Strawman. We should be looking at hard financial numbers etc.... I know...

[held]

Setback with withdrawal of marketing application for the EU.

Seems Telix chose a alternate approach for speeding up the application via the DKMA over the conventional path. So not sure who is wrong. Maybe Telix should have gone the more conventional path for the application?

Either way this is disappointing and is a setback for revenue from Europe.

Possibly 1-0 to Novartis.

Will hold but won't "average down" on this as I don't know the full story behind this setback.

[held]

For those looking at the 4C report why the receipts don't total the $22m in revenue, some of this hasn't been recognised yet from an accounts perspective.

The Company notes that the net operating outflows (used to calculate runway) include only $3.8 million from U.S. customer cash receipts compared to the U.S. commercial revenue of $19.3 million due to timing differences of revenue recognition and cash payment terms from distributors

I was initially confused too.

Looking forward to the next update when the revenue is finally recognised.

Held.

Ann: Telix Enters Licence Agreement with Lilly for Olaratumab

https://finance.yahoo.com/news/telix-pharmaceuticals-announces-licence-agreement-224600702.html

Looks like they paid Lily for license so they can develop a radiolabelled olaratumab for diagnosis of certain human cancers.

I don't know enough of how this benefits Telix given the payments they must make to Lilly to use the antibody.

Held.

Commercial Launch: Illuccix Now Available to Order in the United States

Telix's Prostate Cancer Diagnostic Imaging agent Illuccix is now available for use for patients in the United States. A significant development as it means Telix can now start earning revenue. Only information missing in the announcement is the price although customers can claim via Medicare/Medicaid.

This news also means Telix has a small head start over Novartis who were working on a similar Gallium-based cancer imaging agent being made available in the United States in the next few weeks after FDA approval was received last week.

Looks like lots of competition in this space and perhaps another reason why the price has been hammered recently. But hoping this news release could put a bottom in the price.

Dr. Christian Behrenbruch, Telix Group CEO and Managing Director said, “Physicians across the United States are now able to order doses and schedule patients for Illuccix scans. This important milestone significantly improves access to PSMA-PET imaging across the United States and allows physicians to confidently schedule dose delivery any time of the day, optimising flexibility and control for patients. With the recent approval in the United States2 of PSMA therapy - and the importance of 68Ga-PSMA-11 for patient selection - it is an exciting time for molecular imaging in GU-Oncology.

First doses are already being scheduled for April in key academic centers across the U.S. including University of Washington. “We are excited to be one of the first locations to bring this new imaging to our patients.” says Dr. Delphine Chen, Professor of Radiology. “It brings a new dimension to our ability to stage and treat prostate cancer and can ultimately help us improve our ability to manage the full extent of their disease.

Eligible customers can claim reimbursement for Illuccix under the Centers for Medicare & Medicaid Services (CMS) Not Otherwise Classified (NOC) code. The Healthcare Common Procedure Coding System (HCPCS) reimbursement code assignment is anticipated in the near term and will be completed in accordance with the publication timings set by CMS

Held

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