James McBrayer
Matt, I'll just bring up my presentation now. Let's see here.
Get my glasses on. Here we go.
Great. Thank you everyone for joining us this morning.
As I take you through the results of the first half of 2026, there are three things I want to leave you with. First, we delivered a fifth consecutive record revenue half.
Secondly, the United States has moved from promise to performance. Third, a few weeks after the close of the half, United States Societies of Nuclear Medicine published an international clinical guideline that named Cyclopharm's proprietary product, Technegas, as the preferred ventilation imaging agent of choice.
This is our standard disclaimer. Also, this presentation was released on the ASX last week.
Going here... there we go.
The headlines at a glance: the top row are the financial headlines. For the half of the revenue, $17.5 million, up 14%, our fifth consecutive record half.
The US Technegas revenue up 74%. Gross margins up 53.5% to 56.3%.
Margin improvement is driven by the shift towards higher margin Technegas, in particular US Technegas. And $12.2 million of cash after a $13.5 million net raise.
The bottom row is driving the top: 83 revenue generating US locations as at mid-August, 70 at 30 June, 35 a year ago; 1,684 locations actively engaged in the pipeline, about a third of the addressable US market. On 29 July, new guidelines naming Technegas generally preferred when available were released.
Every number on that top row was achieved before those guidelines existed. On the loss, $8.8 million against $7.7 million last year.
That result is deliberate, as a result of our US investment, our R&D nearly doubling to $600,000 as we advance beyond PE indications, and the absence of last year's $1.1 million joint venture profit after we sold the non-core Cyclotek interest. I'll come back to cash at the end.
A quick snapshot of what we do: to orient you to anyone new to our story, Technegas is an Australian invention, a ventilation imaging agent that shows how lungs actually work, how they function, not just what they look like. Technegas is available in 67 countries, direct distribution in 17 of those.
More than 5 million patient procedures have been performed. The number that really matters: in our established market, Technegas holds a market share of 85% or more of nuclear medicine ventilation imaging.
This is the adoption curve we're now replaying in the United States, the largest healthcare market in the world. We report our revenue in three streams.
For the first half, US Technegas grew 74% from $1.2 million to $2.1 million. Rest of the world Technegas increased 13% from $6.4 million to $7.3 million.
Third-party distribution was up 4%, delivering $8.1 million in revenue. This was a good result given capital projects are intermittent by nature.
Again, overall, we posted a total revenue of $17.5 million, up 14%, our fifth consecutive record revenue half. The point of this slide is not the total, it's the shape.
The fastest growing stream is also the highest margin one. In the US, consumables run at greater than 90% gross margin.
That's why the group margin moved from 53.5% to 56.3%. This is a slide to remember: US Technegas revenue up 74%.
The revenue generating primary sites, 35 at June last year, 70 at June this year, doubled, and 83 as at mid-August. Look at the pace: 20 new net primary sites in the eight weeks between our AGM on the 8th of May and 30 June.
The US is now ranked number one globally for Technegas consumable revenue in absolute terms and per installation. The 83 sites at 12 August are linked to a further 429 contracted affiliated locations.
That's a significant expansion runway driven by customers who've already signed, already trained, already decided. For those, no new enterprise network relationship is required.
54%—this is a number to remember—54% of our revenue generating US locations are expansion units, a second or subsequent installation inside a customer that already has Technegas. We're no longer publishing our overall customer list for competitive reasons.
However, the statistics speaks volumes: roughly half of the US News Honor Roll, the 20 most acclaimed hospitals in America, use Technegas. All 20 are engaged in our pipeline.
18 of the 100 largest US hospitals, 27 of the 200 largest, 13.5%. About 85% of our customer organizations are academic medical centers or major teaching affiliates.
That last one compounds. These are the institutions that publish the research, write the protocols, and train the specialists.
Every resident trained at Technegas carries that preference to their next hospital. We're already seeing this benefit.
Then look at what those institutions do once Technegas is implemented: 82% of our revenue generating locations sit inside multi-location customer groups, and 23 of our 38 US customer organizations now run Technegas across multiple facilities. There is no stronger evidence of clinical utilization than a customer expanding the service within their own network.
The expansions we did recently announce tell that story: University Hospitals, all 11 sites now revenue generating; Penn Medicine, two installations with an 11 site potential; Northwestern Medicine in Chicago with a seven site potential; and an expansion within Massachusetts General at Brigham and Women's. Some of the most discerning health systems in the country each choosing to go wider.
Even since publishing this presentation last week, we've already added two more lighthouse facilities. The federal sector is the other major part of the Technegas story: nine federal locations are now live.
Under the October 2024 national contract, we now serve six VA hospitals with a seventh now contracted, two military hospitals, Walter Reed and Brooke Army Medical Center, and the National Institutes of Health. Federal procurement is reputably slow and undergoes a different approval process to the academic centers.
We've successfully proven, given the clinical importance of Technegas, we can navigate the supply chain and compliance across a government network with 23 distinct procurement groups. Our overall site numbers today is a modest base, but very high in caliber.
We are reaching critical inflection point: a growing federal network, institutions that are set clinical practice, the institutions that scale it internally, and that standardize the use of Technegas. That is the foundation of our rollout is built on.
The international guidelines that have just been released are the undeniable proof of the clinical importance of Technegas in the US. This is our US pipeline as at 12 August.
It's the detail driving the numbers I've already provided. I'll make a few comments.
First, mid last month we were at 83 primary sites, that number has already increased. Second, we are proving that primary installations expand into their affiliate locations.
Third, and pleasingly, since the guideline release we're re-engaging and making great progress with those sites that were on hold. Fourth, once a site moves to committee review, it has clinical backing.
Once it's in contract review, implementation is sure to follow. We're only getting started.
This is a snapshot of our addressable market. We're data-driven.
This is CMS numbers or actual Medicare claims. The data we mine allows us to see referring and nuclear medicine physicians.
It also distinguishes pulmonary embolism from other indications. There are 5,139 US locations performing nuclear medicine lung imaging.
We regard approximately 2,000 of those as our primary market. We expect both the total addressable and targeted market numbers to grow as we expand beyond diagnosing PE.
However, PE alone represents a US $180 million annual revenue opportunity for Cyclopharm. We've built a strong runway and we expect to deliver greater than that 85% market share in the US, the same market share that is already played out in every established market we operate.
Let's talk about the recently released guidelines and why they are so important. In fact, this is arguably the most significant development in the company's history, and it happened officially only a few weeks ago.
On 29 July, four societies—the US Society of Nuclear Medicine and Molecular Imaging, the European Association of Nuclear Medicine, the American College of Nuclear Medicine, and the Australian and New Zealand Society of Nuclear Medicine—jointly published online in the US Journal of Nuclear Medicine a new procedure standard for pulmonary scintigraphy, or lung imaging. This was the first update to the US guidance in 14 years.
It replaces the previous 2012 standard, and it's the first single lung imaging standard that aligns the US, Europe, and Australia, New Zealand. Guidelines are the rule book.
They set how a scan is performed and interpreted, and they are what hospital committees and health insurers point to when deciding what to implement. In other words, they define the standard of care.
Guidelines of this kind are normally brand neutral. This one is not.
Technegas is mentioned in the introduction, it's defined in the glossary, it's been given its own dedicated section, and, importantly, Technegas is recognized as preferred when available. Our subsidiary, Cyclomedica, is named as the manufacturer.
Even the equipment section specifies our system and our single patient use consumables. In contrast, competing agents appear under generic headings.
You can take three commercial consequences from this guideline. First, it calls for a move to three-dimensional imaging in the US, where the competing agents are weakest.
The second key point: dose and safety. A nuclear medicine scan with Technegas delivers a breast radiation dose up to 70 times lower than a CT pulmonary angiography, and about 10 times lower even with a low-dose CT.
The standard names five patient groups where our scan should generally be preferred. They are: premenopausal women, pregnant patients, impaired kidney function, contrast intolerance, and suspected chronic PE-related lung disease.
The third point: the new guidelines identifies AI as a fast-emerging tool and states that Technegas's base data requires no correction, exactly what our AI collaborators need. Until 29 July, our US team was asking hospitals to adopt Technegas, a product that was previously listed in the 2012 US guidelines as unapproved for use and unproven in the US.
That barrier has been removed. This is not our marketing claim.
It's the profession's own clinical position, a global consensus that is freely accessible to every clinician, committee, and administrator in the US and around the world for that matter. Furthermore, it's the defined standard of care for at least a decade to come.
Everything we've built in the US—our existing and imminent installations, our 1,684 location pipeline—we've built without this clinical treatise. With it in hand, we're only getting started.
Why did the profession update their clinical practice guidelines? How did we get to this enviable position?
The answer is twofold: technology and Technegas. Regarding Technegas, more than 5 million patient procedures worldwide, over 230 published papers, more than 2,400 scholarly citations.
Guidelines sit at the very top of this pyramid. You don't get there on marketing.
You get there when the accumulated evidence becomes strong enough that the profession changes its own rules, which is exactly what happened on 29 July for Technegas in the US. Technology is the other driver.
Ventilation imaging has moved from flat planar images to three-dimensional SPECT, and now to hybrid SPECT/CT that delivers three-dimensional, region-by-region measurement of how each part of the lung is working. The new guidelines pushes the US down exactly that path, and identifies three-dimensional scanning as the preferred technique.
That matters commercially. The more advanced the imaging, the wider the gap between Technegas and the alternatives.
The evolution hasn't stopped. The next step is already underway: AI and quantification software layered on top of SPECT/CT combination, taking analysis down to segmental and subsegmental levels.
We are seeing a rapidly growing software layer, and all of them need to draw upon that base data. Which brings us to the next slide: where that functional data comes from, and who is already building on it.
At the heart of that AI evolution is function. Function comes from nuclear medicine.
CT shows you what a lung looks like anatomically. Nuclear medicine shows you how it actually is working region by region.
Every tool on this slide is built on the division of labor: our functional data layered on CT anatomy. I want to highlight that CT contributes when paired with nuclear medicine.
These platforms are using a low-dose, non-contrast CT purely for anatomical registration, a fraction of the radiation of a standalone diagnostic CT, let alone a CT pulmonary angiogram. Patient gets anatomy and function together, and still at a far lower dose.
The software space around this is growing very quickly, multiple platforms here: the major imaging vendors, the radiotherapy planning vendors, and the open-source community doing lung quantification, ventilation/perfusion mismatch, functional avoidance planning, functional dose-volume histograms. Why it all matters to us: none of this works without a clean functional data input, and the new guidelines state that Technegas's base data requires no correction, no algorithm.
Every one of these platforms raises the clinical value of Technegas scan without us spending a dollar on development. This whole software layer depends on the quality of the functional input, which is where the unique Technegas particle itself comes in.
I had to give you at least one science slide. This is the magic behind Technegas.
Technegas's particles are a few nanometers in size, far smaller than a red blood cell, only slightly wider than a strand of DNA. They behave like a gas going in, spread evenly throughout the smallest airways, and then stay there.
That's what gives you an accurate, region-by-region picture of what oxygen is actually being delivered. A CT scan shows you what a lung looks like, Technegas shows you how it's working.
No other approved agent does that with the same fidelity or anything like the same low radiation dose. This slide illustrates the Technegas barrier to entry.
Technegas is not a drug on its own. It's a drug plus a device plus a service and consumable model.
It's regulated as a combination product in the US. A competitor has to replicate all three and clear the regulatory path for all three.
That's why we have had no equal in this field and why the new US guidelines specify our system and our consumable by name. Where to from here?
Pulmonary embolism is the beachhead for our indication for use, not the destination. Technegas measures lung function.
Lung function matters in every respiratory condition, not just clots. Beyond PE is an additional addressable market estimated at over US $900 million globally, taking the total long-term opportunity for Technegas to over $1.1 billion.
Critically, the new guidelines validate this strategy for us. The guidelines reference chronic PE-related pulmonary hypertension, follow-up scanning three to six months after a clot where residual blockage carries a two to threefold higher recurrence, lung function before and after lung surgery or radiotherapy, lung transplant assessment, and grading of small airways disease, which includes COPD and asthma.
Here's the commercial point that matters most: every one of those indications already falls inside our existing broad US FDA approval for the visualization of pulmonary ventilation. That's the quote: "visualization of pulmonary ventilation."
No further regulatory approval, no delay, no cost. It extends the value of every system already in the field.
Clinicians still need the evidence, and we're building that case with the latest and the best complementary technology, to include AI. Trials continued through the period: the Woolcock Institute study in mild-to-moderate COPD, and the multicenter PRONOSPEC trial in France in recurrent venous PE.
Again, the guidelines note that Technegas base data requires no correction, an ideal input for our AI collaborations. Turning back to our results for the half, the established business supports our US expansion.
Rest of the world Technegas revenue is up 7.3—up 13% across our 66 established markets. Third-party distribution, contributing $8.1 million, up 4%, built from our standing start in 2020 off our own sales, service, and regulatory presence in our direct 17 markets.
During the period, we achieved an operational milestone worthy of note: we secured the final wholesale pharmaceutical licenses to distribute in our own right across all 50 US states. That gives us independence from outsourced distributors, more control over margin and customer relationships, and opens third-party distribution opportunities of our own.
On capital, during the half, we raised $13.5 million net with institutional placement and plus a share purchase plan. At the half, we closed cash at $12.2 million.
The statement that matters: we believe we passed peak cash burn. The logic is simple, though: consumable revenue carries a gross margin in the US greater than 90%.
Importantly, our commercial infrastructure is already built and largely fixed. We have an inventory on the ground in the US already there.
Each incremental sale needs almost no additional cost. As the installed base grows, monthly net cash consumption falls.
The bullets on the left carry our derisked proposition: reimbursement secured, federal and private network contracts signed, new guidelines published. For any product launching in the US, we are in a very unique, even unprecedented position at this stage of a launch.
Now the map: we're now present in 22 states, collectively holding 239 million people. We have only just started serving that population from our 83 sites.
Look at how we grow along the arrows: we land a leading institution, it expands internally. That number again, 54% of our sites are expansion units inside existing customers.
Then it pulls in its affiliated networks, 82% of our installs now sit within the multi-site groups. From there, it radiates.
A leading academic center gives us the reference, the clinicians, the reputation, and the published data to win the region around it. We're not buying growth market by market.
We're compounding off institutions we've already earned. Of the 5,139 addressable sites, we target 2,000, and we're only in 83, 4%.
The derisking is done, and we're only getting started. Bringing this all together, there are five key reasons to back Cyclopharm: one, a profitable growing medtech.
The business outside the US is cash positive. We're past peak cash burn, and group gross margins improved 53.5% to 56.3%.
Two, we're first-in-class, 67 countries, over 5 million patient procedures, 85% plus share of the ventilation imaging in our established markets, and now written into the profession's own clinical standard. Three, US growth is accelerating: 83 revenue generating sites as at mid-August, a 1,684 location engaged pipeline, marquee federal and academic reference sites, a fully deployed commercial team, and now the guidelines.
Four, recurring revenue: roughly generating around US $70,000, US dollars a year per larger sites, consumables are greater than 90% gross margin. Five, our real growth is ahead of us: product expansion beyond PE that is accelerated by AI, all of these opportunities sit within our existing FDA approval.
As I told shareholders at the AGM in May, the US is not a hope, it's happening. In closing, Technegas is a proprietary, clinically proven technology with no equal in its field, scaling into the world's largest healthcare market, leveraging off this very moment the greatest clinical and commercial validation in its history.
We'll report the quarterly pipeline updates through the remainder of the year. I want to thank you, and I'm happy to take questions now.
Moderator
Thanks, James. As you've mentioned, we'll move on to Q&A.
As a reminder again to the audience, if you have a question you'd like to submit, please do so by typing it into the Q&A function within Zoom, and I'll jump into those now. The first one I have that came through via email, James: "There is a feeling in the market the company will need to have a further capital raise in the next six to 12 months.
To help alleviate this concern, can you please speak to the cash position, burn rate, and how this will reduce as projected installations occur?" Yes,
James McBrayer
thank you for that question. At the end of the half, we reached 12.2, as mentioned in the presentation.
We have reached cash burn peak. Every installation in the US generates high margin with every installation.
The board has no immediate plans for any type of capital raise, but we're always looking at opportunities that avail themselves.
Moderator
Thank you. The next question is, "Will the company look at paying a dividend anytime soon?"
James McBrayer
We know that that's very important for our shareholders. Historically, we paid dividends.
Once the US is firing, it's going to be very cash generative, and we will be reintroducing a dividend at that time.
Moderator
There's been a couple of questions come through just with regards to breakeven point. Can you just maybe speak to what needs to happen for the company to reach that point?
James McBrayer
I think we talked about the benefit of the US and the margins that we're driving. There's a couple of different drivers in that.
We're dealing with large contracts, those tend to fall into place with large institutions generating over 70,000 US per annum. The speed at which that we generate, of course, is going to bring us to profitability that much sooner.
We're delivering on that, and the speed in which we're driving that on the back of these guidelines, we're expecting great things.
Moderator
Thank you. The next question I have is, "How does your third-party distribution business work?
Can you speak to key partners, profitability of this, and the scope for growth?"
James McBrayer
I think I'll start with the reason behind that. We're in 67 countries around the world.
We're in direct in 17 of those, meaning that we have our own service, sales, and regulatory support in that. That's a very unique and valuable asset, an asset that companies much larger than ourselves are leveraging because we can deliver those aspects.
From a standing start in 2020, it's become a significant contributor and it adds to the overall profitability of the company. We continue to add and discuss with third-party players to represent their products.
We've seen a great demand because typically distributors don't care about your product as much as you do. We've turned that around and we've been delivering it for a third party.
A lot of it is a mix between, like Technegas, you have a capital piece of equipment that goes into an infrastructure, those can be lumpy in revenues, but we have that ongoing consumable, the razor/razor blade model like Technegas that drives that. We're going to continue to expand that in our existing markets.
Moderator
I think this was covered off during the presentation, but just for the person that asked, "What is the current number of actual installations and those currently under contract awaiting installation?"
James McBrayer
It's in the presentation. We've been very, very transparent about our pipeline.
We'll be updating that on a quarterly basis. At the time of the announcement for the financials, we had 83 revenue generating installations in the US.
That's already grown and will continue to grow. We'll be giving those updates periodically.
I think I'll kind of back up in the way that we present the numbers in the pipeline. The primary sites are the ones that we're actively engaged saying that they're going to start with the Technegas systems.
The affiliates are an important part, and that goes back to that 54% number. Once we get an established site, it grows from there.
Those affiliate sites, although that may not be from day one, we expect it to grow from there. Even conversations I've had with the team in the US this morning, we're starting to see some growth even in our existing base today.
The numbers are in there, it's in the table, and track us on that. That's showing the growth.
We're very excited about the fact that Labor Day is the official end of summer, and committees are back on deck after next week. While we've welcomed the guidelines that came during the summer, we're hitting the ground very hard with the guideline starting next week.
Moderator
The next question I have is, "Are you subject to US tariffs, and if so, have you raised prices?"
James McBrayer
We're in an enviable position right now in that, unlike a lot of producers shipping into the US, we're the manufacturer, we're the exporter, we're the importer, and then we're the distributor. We have our hands on a lot of levers.
We've also had a stock buildup in the US before some of these tariffs. We haven't taken that for granted.
We've engaged at multiple levels in both the US and here in Australia. At present, we have a small tariff on that, but again, this is based on transfer pricing into the US, but we're watching that very, very closely.
As it's a dynamic landscape.
Moderator
Thanks, James. That's all the questions that have come through.
I'll just throw it back to you to provide a closing comment if you'd like.
James McBrayer
I think I summed it up at the very end when we talked about the deliverables and we're in a very, very unique position for any company. We consider ourselves still in launch phase in the US, launching with an international guideline US-based that names your product by name as the agent of choice.
We have some of the leading institutions in the US, a who's who of who you want to have your product in, and we're starting to see that all the work that we've been putting in, all the work that we've had with reimbursement, setting these lighthouse sites up and running, we're starting to see the momentum picking up, and it's going to be an exciting time.
Moderator
Thanks, James, and thanks to everyone for joining, and we'll look forward to bringing you more news soon.
James McBrayer
Thank you, all.
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