Ann: 2022 Full Year Results Presentation, page-45

My highlights for anyone not wanting to read the whole lot:

"We had a great launch quarter, followed by a very healthy Q4, which we previously reported on. And we see no abatement of this trajectory over the next few quarters."

"It's clear that the prostate cancer market is much bigger than we all anticipated. We expect to see these growth rates largely continue."

"And we certainly see strong growth demand across both our existing customer base on new customers as well. So this is a market that's evolving really rapidly. Of course, we all associate PSMA with prostate cancer, but there's potential and other indications as well."

"So I think this is really an exciting time for PSMA and Illuccix is a well-respected product that's getting great customer traction."

"We are having customers that are expanding their imaging hours. So they're going in the weekend. We're providing stat doses on a regular basis where our competition fails to deliver to a customer. And so we really feel, again, that this business model is giving a lot of flexibility to customers, and this is increasingly recognized in our dose demand."

"Part of it is that we've invested heavily in our sales and marketing team. I think we've really upgraded our commercial infrastructure. We transitioned from a start-up company to kind of grown up company and really replumbed our commercial team and I think that the quality of the people that we have now in sales and marketing and also on the clinical support side of things, is just very, very strong. And that's one of the key weapons that we have going into 2023."

"Illuccix PSMA imaging is really becoming standard of care for patients throughout their pathway and we'll be looking as we continue the year to validate new indications, looking at areas where we can improve the care of patients, both in early prostate cancer and throughout their prostate cancer journey."

"From a company perspective, our main focus is here is that BLA submission to be in a position to do real commercial launch in the early part of next year, certainly initially in the United States and then eventually in other territories as well."

"We also have a second product this year that we are getting towards an approval for, which is TLX101. It's our brain imaging product, PEP. This is a standard of care, modality in a lot of countries, but it doesn't yet have commercial availability in the United States. It's the companion diagnostic to our therapy program. And we think that this has a nice potential revenue stream to layer on top of prostate cancer and needle cancer. And so the team we scaled up the regulatory and clinical and quality teams to be able to really now address these 2 additional regulatory filings this year, and we're making great progress towards getting those filings in place."

"We would expect at some stage towards the back end of next year to have some interim data on the ProstACT GLOBAL study as well."

"Kyahn mentioned in the opening comments about manufacturing. This is an area where we continue to focus a lot. We've got great partners and a really critical part of our commercial strategy is, of course, to tap into the network of isotope supply chain and drug product manufacturing partners that are out there and growing as the field matures. But really, any company that reports to commercialize radiopharmaceutical really has to have a clear strategy and game plan for managing the supply chain."

"And this past 12 months, we made some really important progress. First of all, not to supplant key partners and vendors that we need, but we now have some in-house process development capability on sensitive projects, particularly we're collaborating with a pharma partner, and we'd like to keep a little bit more of a lid on what we're doing. Also, so that was part of the driver for acquiring the Optimal Tracers platform."

"Kyahn referred to R&l research and innovation. And we'd like to take things that are clinically fairly well established and take them to commercialization. That's really the company's strategy from a product pipeline perspective but Alpha Therapies with things like actinium and acetine, this is a big future frontier.And the vast majority of people dabbling in the Alpha Therapy space don't have a place to actually do the work."

"The research environment and the equipment and the facilities that you need to really do scale-up work with Alpha doesn't exist clinically on the planet right now. And I think that the infrastructure that we've built in Seneffe to kind of very stealthily get into that space is going to be a great asset for the company going forward. Just a lot of interest in that capability."

"We've also acquired pipeline around understanding the tumor microenvironment, and you're going to see more of that. That's really how to use noninvasive methods to really understand how that tumor works and what are the mechanisms that are likely to elicit a response."

"We have a healthy program in Al. I think this is an area where more and more attention is being given in our field. clearly, to make the imaging results have impact on the therapeutic deployment, we have to connect those dots and Al and image analysis and machine learning are a key way of achieving that objective."

"And then unsurprisingly, if you look at the Illuccix label, particularly the high-risk patient prior to prostatectomy. If you look at the outcome of the ZIRCON study, which is really a preoperative interrogation of the disease, surgery and particularly the urologist as a surgical stakeholder is something that we have more and more of a focus on. And so we're starting to ask really interesting questions about how do we bring radiopharmaceuticals into the operating deal? How do we make it possible to do better interoperative guidance, whether that's either radiation or florescence."

"And we have a pretty exciting R&D program, including with some partner companies we're actively interrogating this question in clinical trials and in clinical development. So it's a really exciting potential area to develop the depth of relationship, particularly with neurology."

"So one of the things that you may have noticed when we gave our JPMorgan presentation earlier this year, beginning of this year, for the first time, what we've done is we bifurcated what's our core pipeline. This is really the assets where we believe we have the clinical data to support commercialization and then now really to start to showcase what our research pipeline is. And I don't think that there's a good understanding of just the depth of R&D pipeline that we have. What's exciting is, by the end of this year, we are going to have clinical data in all of these programs."

"By the end of this year, we -- I mean, some of them are clinically active already. But what we really are going to understand by the end of 2023 is today. we've got those 4 key asset areas in the core pipeline. That's essentially the Telix commercial pipeline and let's say, 2025. And what this slide represents is what's the Telix pipeline look like in 2028 to 2029. And I think it's great that we have the ability to take that long-term view of how we're going to be legal in this field, how we're going to life cycle manage our products.And that's really what this R&D pipeline gives us."

"And we'll be very judicious, of course, on how we expand this pipeline. We've got a lot on. I think some investors would say, well, maybe we have even a little bit too much on. So when you do expand the pipeline, we'll be very cautious about the merits of doing so, but it's great to have that future pipeline for the business."

"So just as a little showcase example, I think this is a kind of a capstone in this presentation, one of the exciting clinical trials are just about to launch for us is called the STARLITE trial. And it's based on the work that we've been doing for the last approximately 2 years with Merck, Darmstadt on DNA damage response inhibitors in combination with targeted radiation. We now are starting to really understand how to use this combination. Now there's a bunch of combos in our pipeline, which are exciting as immuno-oncology ones. Obviously, there's energy deprivation combination and prostate cancer. But we - - when we look at 250 program, when you look at carbonic and hybrids 9 as a target, and we see that as a multi-cancer pan-cancer target."

"And then we look at the abilitv to give ultra-low-dose radiation in combination with the DNA damage response and hit, vou really start to see why Telix is so committed to an antibody-based approach. What we are able to do is deliver very, ver efficiently radiation with tumor, very low-dose radiation. So we have no major toxicity concerns and the ability to combine that with a DNA damage response inhibitor for efficacy is just is really exciting."

"And so instead of the traditional approach where you send a patient in every day or every other day, you get fractionated radiotherapy, what you're doing is that you're giving them one shot of radiation and then giving them an oral drug. And they're taking that oral drug every day for 14 days in order to achieve for 28 days in order to achieve that fractionated radiation effect. So this is really a game changer in the way you think about delivering and fractionating and sensitizing the patient to radiation."

"And again, because with carbonic and hydrates 9s, pan-cancer utility, it really is a multi-cancer almost a very large proportion of late-stage cancers who have a core prognosis or carbonic and hydro 9 express and we see this is something that's potentially able to solve and address a lot of unmet medical needs."

"We're now in a position where we can fund our current research and development pipeline program out of our own generated funds."

"Interestingly, and that can be seen in that half-on-half comparison on the abbreviated P&L, the continued growth of our Illuccix revenue is driving improvement in our bottom line, even as we actively invest in the future of Telix. Continued revenue growth and active management of our expenditure as a percentage of sales has permitted Telix to improve its second half performance by $42 million over the first half of the year."

"And I think just to summarize, the mission that we had when we raised our capital last year was to make that commercial transition that we've clearly demonstrated that. It can factor in the R&D tax credit that we give you get this year as I said, was a part year in terms of R&D expenditure. Of course, we invested on the commercial team, and we continue to do that. But I think it's from a financial trajectory perspective, it's a very encouraging place to be. And as I said, we don't see no abatement in our opportunity for Illuccix then to have the follow-on revenue streams that we anticipate over the next 12 to 18 months. It's a really strong place for the company to be."

"Clearly, we will continue to grow Illuccix. We have indication and label expansion plans for Illuccix."

"We really think that we have the best pipeline to offer and to be part of defining standard that that continues to be a key area. And then by the way, we invest about 20% of our R&D in Illuccix. So R&D is not just about Blue Sky pipeline expansion therapy programs, but it's about making sure that we are building all the debts that we possibly can in the Illuccix. And then clearly, we've got 2 more drug approvals to file this year."

"Obviously, focus in the U.S. market, but we are a globally active company. We continue to run clinical activity globally for these assets and to a large extent, particularly for the 2 program, that is something that we intend to roll out globally. So good year ahead. We scaled up our regulatory and quality and clinical teams to be able to deliver on that. And that's a really exciting activity to work on. All goes well. According to plan early next year, we'll have more than one product generating revenue for the company, which is super exciting."

"And particularly given that the renal cancer product is the same customer call point, we're out talking of the same referral physicians and Illuccix. That means that SG&A investment that we have in our U.S. sales force was something that we get to kind of double down on from a product efficiency perspective."

"And then last of all, I certainly get a lot of feedback from shareholders and investors that the sympathy for the supply chain and distribution realities of coming out of COVID, but we are as impatient as everybody else is to have prospect global fully operationalized, but we made tremendous progress last year in laying the manufacturing and distribution framework for that. And I'm really excited to have those trials. We have 2 of the 3 trials, obviously, fully operationalized, but to be able to recruit U.S. and some European patients into that study with across that global study is going to be a big milestone for the company and I think one that's as anticipated by the company as it is by shareholders

"So again, great progress made last year. And Colin's team will deliver the fruits of that labor this year in terms of clinical activity. So yes, big activities. I think for the average company, any one of those thoughts would be something that would command plenty of effort and attention. But we've got a big year ahead and we're excited to keep you abreast of our progress at the opening."

Q&A

"Illuccix EMEA: So we are getting ready right now. We have a package ready for resubmission. We're just getting ready to submit. The expectation is that we will still do that by the end of this quarter as we previously guided. We will not be able to give clear firm time lines yet on what the approval looks like because it depends a little bit on some nuances of that resubmission process. But obviously, as soon as we have that information to share, we will. We would expect to have at least a positive opinion by the end of the year. So I think this year is really about that resubmission process and '24 is likely to be the revenue consequences of that regulatory process."

"Gross Margin: I think Chris and I have an active debate about gross margin and where it's headed. So we -- as an organization, we believe there is an opportunity to move that up to -- in that range of 65% to 70%. So - - but obviously, there's a couple of key issues within the market dynamics, it's going to influence where that finally falls. You have to remember that part of that gross margin bucket right now includes our active investment in sales and marketing functions through our network, right? So it's not reasonable to just treat it really as a cost of goods. It's actually an investment in growing our market share. So I think at the moment, from a company perspective, we're sitting on roughly 65% growth mark 64% to 63% gross margin as a highly cash-generative business."

"Funding: We haven't given guidance, but there's no particular reason for our R&D expenditure to accelerate. So it's obviously always a little bit chunky because we've got clinical trials and manufacturing activity that's going to be there. There shouldn't be any sticker shock on R&D for '23 and it will be funded through earnings and will not be funded to a capital increase."

"Illuccix: Well, I was just pointing out that we have had 2 quarters of sales post reimbursement. And we don't -- we don't see any reason for that sort of nice linearity of sales profiles to not continue. We've seen lots of headroom left in the market. There are some clear white space market segments. We are capturing market share from our competition. And so I think that we should continue to see good quarter-on-quarter sales. That said, we've also been very transparent in our view that by sort of Q4 of this ear, we should see a largely penetrated market."

"Novartis: I'm not the CEO of Novartis, so I can't speak for what their strategy is. But what it appears to be, and I think it's a reasonable statement is that we're very much focused on delivering therapeutic outcomes to their patients. That's - it's a topic that's garnered a lot of attention, and it certainly reinforces the importance of core of supply chain and distribution. But I think it's fair to say the whole industry is gunning for Novartis to be successful. And the flip side to that is for or could it go to be successful ubiquitous PSMA aging has to be there. And so it's pretty clear that Novartis is taking a every patient's scan is a win for Novartis kind of approach. And the fact that Novartis is not particularly emphasizing a commercial diagnostic business and is supporting us and Lantheus and potentially others to make sure that no matter where you live, no matter what your social demographic is, you have access to PSMA imaging. I think that really kind of speaks to their focus in their strategy."

"Early data readouts: We have a -- this field has a ton of interest. I think it's fair to say that the top 20 global biopharmaceutical companies are all looking at radiopharma as the next frontier area. And we need to have that interim readout to show where we stand in the path when it comes to partnering. And with the imaging indications, we have no different. Diagnostic imaging is a very compact market. You can probably 60 KOLs that matter. Distributing the product is not that challenging. It's still a large volume product, but from a sales and marketing perspective is very compact. Clearly, when the time comes for us to push out a therapeutic prostate cancer product, that's going to require a go-to-market partner. And so we need that data point. And so there's a commercial rationale for it as well as a clinical one."

"Will staff costs continue to accelerate as the business Illuccix into multiple streams in calendar year '23?: I mean, in short, we are continuing to grow the business, but the growth is a function of revenue. So yes, we are internationally expanding Illuccix sales. We are also -- we've done, I think, a really great upgrade to our sales and marketing team. We've triaged our sales team as a function of commercial performance, and we brought on new marketing firepower, which is really, again, part of that growth in maturation."

"I think 2022 was sort of an ugly teenager year for the company. And when you're in a hyper growth environment, people have a short duration of contribution to make, and then we rapidly outgrow. I think we're at the stage now where we have a commercial team that's a good, solid, steady state commercial team that we can incrementally build on as we need it. As Colin mentioned before, we have invested in clinical and regulatory resources got a lot of clinical trials running. Again, that's a modest increase, but it's still nonetheless an increase. But I don't think you're going to see any -- 2022 was a dramatic growth year for the company. And 2023 is a much more modest ramp up, and it's a ramp-up that's a function of commercial success in that shell."

"Obviously, from an organizational perspective, given that there is that growth going on within the commercial business, fits where the focus will be making sure that we have an appropriate size team to make the most of the opportunity there with Illuccix and then also the coming products that we see coming through from a diagnostic perspective. The other areas of the business around the programs and more head office will probably be a lot later on in a growth perspective. Obviously, just filling gaps that may appear. So overall, what that provides us is an opportunity to leverage the P&L. Sales growth will definitely outstrip our expense growth and including that of employment costs."