Participants are in listen only mode. There will be a presentation that will last for approximately 15 minutes-20 minutes, followed by Q&A. If you have a question you would like to submit, please feel free to do so using the Q&A function within Zoom, and we will get to those at the end. Also note, the session is being recorded. On behalf of Cyclopharm, we have the CEO and Managing Director, James McBrayer, and I will hand it over to him now.
Thanks, Matt, and good morning, everyone. We are not required to report quarterly, but we want our shareholders to see our progress as it happens. This quarter, there is a great deal to report. Cyclopharm is only getting started in the world's largest healthcare market. A quick note on the safe harbor statement. Today's presentation includes forward-looking statements. The third quarter figures are unaudited, and we are not providing guidance today. For those new to our story, here is Technegas in a nutshell. It is an Australian-invented lung imaging technology. It is made at point of care on-site at the hospital. The patient only needs to breathe three-six breaths to administer Technegas, and it travels all the way to the alveoli, where oxygen is exchanged, showing true functional ventilation. A camera then images in 3D.
Pair that with a perfusion scan and you have the V/Q scan historically used to diagnose pulmonary embolism. Technegas is used in 67 countries with more than five million procedures. It was US FDA approved in late 2023, and it runs on a razor blade model. We place the system once, and every scan uses our consumables. Hybrid imaging and AI leveraging Technegas data are contributing to a new era in pulmonology. Hold that thought. I will come back to it. If you remember one number today, make it this one. For the quarter ending 30 September, 76% of our U.S. sales came from consumable orders at existing sites. That is up from 58% in the June quarter. The majority of our U.S. revenue now comes from ongoing sales in the installed base.
That is the razor blade model working, and it is the annuity model that has delivered our largest U.S. quarter ever. $1.62 million, up 124% on last year and 45% on the June quarter. Nine-month U.S. revenue of $3.8 million is already 40% above the whole of 2025, and our installed base reached 84 systems, up 83% in just six months. Look at the bottom row. I will speak more about the new guidelines later, but they only landed on 29 July in the middle of the U.S. summer, and by 30 September, committee reviews were up 71%, contract reviews up 61%, and 30 locations had come off hold. We are now engaged with 1,877 locations, more than a third of the U.S. market. The U.S. growth is leveraging off a solid global commercial base.
Global revenue for the nine months to 30 September was AUD 25.9 million, up 13.7% on AUD 22.8 million a year ago. We held AUD 9.6 million in cash at 30 September. Importantly, our cash burn has declined rapidly. We averaged AUD 1.8 million per month in the second half of 2025, AUD 1.3 million per month in the first half of this year, down to AUD 900,000 per month in the quarter to 30 September. Receipts on a month-to-month basis can be lumpy, but the trend is clear. Why is that? Our U.S. installations are paying back. 76% of our Q3 revenue came from patient consumables at around 95% margin, and our business across 66 other markets, together with third-party distribution, supports the rollout. Another important point to make about our cash position is that a substantial U.S. inventory is already built, paid for, and landed in the U.S.
110 systems at 30 September are ready to deploy there. What is ahead? Here are our catalysts across three horizons. In the short term, we have an installed base up 83% in six months with the guidelines in hand for only three weeks after Labor Day. 186 primary sites are now at committee review and 105 signed or in contract review. In the medium term, we will be taking xenon's half of the market. Landing and expanding across hospital networks, we will be leveraging the shift to SPECT/CT and benefiting from high margin consumables. In the long term, the full US $180 million U.S. market. Then add to that more than US $1 billion beyond PE within our broad existing label that will be driven by AI quantification. The U.S. pulmonary embolism market is worth around US $180 million a year from about 2,000 primary target sites.
Around half of it, roughly US $90 million a year, still uses xenon-133, and that is where we see the strongest conversion momentum. Xenon needs a negative pressured room and a gas trapping system. Administration takes up to 15 minutes, and it is limited to old planar imaging. The new guidelines direct the move to 3D SPECT, to which xenon is not suited. So as aging xenon systems come up for replacement, hospitals have a clear choice. Renew a legacy setup or move to the guidelines' preferred agent, Technegas. The other half of the market is mostly DTPA aerosol, where droplets clump in the central airways and create hotspots that leave more scans indeterminate. In comparison, Technegas behaves like a true gas and reaches the periphery of the lung, showing true function. Here is the momentum.
Our installed base went from 40 systems at the end of 2025 to 84 at 30 September. We installed 44 systems in nine months, more than in 2024 and 2025 combined. Our U.S. revenues tells the same story. From $723,000 in Q3 2025 to $1.62 million in Q3 2026, with patient consumables growing every single quarter this year. A word on seasonality. U.S. hospitals make capital decisions ahead of budget year-end, so growth is weighted to the second and fourth quarters, and the northern summer slows the third. Even so, 13 of our 14 Q3 installations landed in September as soon as hospital teams were back. To one of the most important milestones in the company's history, second perhaps only to receiving FDA approval.
On 29 July, four societies, the U.S. 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, published a joint guideline for V/Q lung scintigraphy. The first update to U.S. guidance in 14 years. Guidelines rarely update, so we expect Technegas to be the standard of care globally for likely the next decade, if not beyond. The guidelines name Technegas, generally preferred when available. It directs the move from planar to SPECT and SPECT/CT. The guidelines confirm a breast dose up to 70 times lower than a CT angiogram. It sets it out beyond PE applications, and it names AI quantification as an emerging complement, noting that Technegas data requires no correction, and it just keeps getting better.
Only weeks after the U.S., European, and ANZ guidelines were released, early in October, the Chinese Thoracic Society and six partner bodies independently named Technegas the preferred radiopharmaceutical. Recommendation number one, in fact, with 100% consensus. What do we have now? We have four continents, one conclusion: choose Technegas. Here's the exciting part. Every U.S. installation we've had to date was one before these guidelines existed. What happens next? Guidelines matter because they shape referrals, hospital committee approvals, capital decisions, and reimbursement. They hold for years. The timing matters, too. The guidelines landed only on 29 July in the middle of the U.S. summer break when few committees were sitting. The first real selling season began after Labor Day on 7 September. This is what we've seen. Just within three weeks, committee reviews were up 71% from 109 to 186 primary sites.
Contract reviews were up 61% from 44 to 71. 30 locations came off hold and engaged primary sites past 1,000. This is only the first pass of the guidelines impact. This slide shows our full pipeline as at 30 September. 84 primary sites are generating revenue linked to 430 affiliated network sites. 514 locations already inside revenue-generating contracts. A further 34 primary sites are signed or installing, 71 are in contract review, and 186 are at committee review. This point is important. Once a primary site reaches contract review, count it. Sites at this stage have historically gone on to convert to installation. In total, 1,877 locations are engaged. This is equal to 36.5% of the 5,139 U.S. sites conducting lung imaging. Why do hospitals say yes to Technegas? First, better diagnosis.
Technegas delivers fewer indeterminate scans than other nuclear medicine agents, and under the new guidelines, nuclear medicine with Technegas provides a better negative predictive value than CT for pulmonary embolism. A normal scan rules out PE with confidence, so we expect fewer repeat scans and faster discharge. Technegas is faster, too. Technegas takes under a minute to administer. This convenience is good for hospital staff, and most importantly, ease of administration is good for the patient. Second, the economics. The hospital buys no hardware. We own and install and service the system. The year one cost is USD 14,000 then USD 7,000 a year. At about 25 patients a year, the hospital breaks even, and a department scanning five patients a week is past break even by the fifth week of the year.
Additionally, moving to SPECT/CT, a clinically superior technique, it pays up to $906 more per study under Medicare. Our customers are among America's most prestigious hospitals. All 20 honor roll hospitals are in our pipeline. About half use Technegas, and 49 of our 84 systems are in the top 200 U.S. hospitals. This is a hub and spoke business. Land and expand works through each hospital's own network and across hospitals in the regions that they service. At University Hospitals Cleveland, one agreement became 11 sites, 362 sites already sit under agreements we hold, and 54% of our revenue-generating sites are expansions inside existing customers. I trust that you've noticed throughout this presentation that every claim is referenced with a footnote on each slide. I do that deliberately. I suppose it's my training as a pharmacist, but more so you deserve facts over fiction.
Let's take a moment to address some of the myths and misconceptions about nuclear medicine. Myth one: Other clinical modalities show lung function just as well. Technegas measures ventilation directly. CT and other structural modalities image anatomy and infer through algorithms and data manipulation how the lung works. Myth two: Nuclear medicine means a high radiation dose. Actually, the opposite is true. A Technegas V/Q scan delivers around one to three millisieverts against around 20 for a CT angiogram. That matters most for children, women, and repeat imaging. Myth three: Nuclear medicine is old technology. Today, nuclear medicine is precision medicine. AI uses our pure functional data, which the guidelines confirm needs no correction to quantify regional function down to sub-segmental levels and help guide which part of the lung to treat. Myth four: It's too cumbersome for busy departments, and our operators would rather not perform it.
Technegas solves all of that. Three to six breaths, that's all it takes. No negative pressure rooms, and now new generation cameras can complete V/Q imaging in five to eight minutes. Which brings us to beyond PE. Technegas is U.S. FDA approved, not just cleared. There is a difference. Technegas was approved through a full new drug application as a drug device combination. Here is the FDA label, word for word. "Technegas is for use in adults and children aged six and over for, first, visualization of pulmonary ventilation, and second, evaluation of pulmonary embolism when paired with perfusion imaging." That first indication stands on its own. It's not tied to pulmonary embolism or any single disease. Every application on the right, CTEPH, COPD, asthma, surgery, and transplant, uses ventilation imaging. No new approval and no large, costly registration trials. Furthermore, the 29th July guidelines already set these applications out.
These represent more than US $1 billion of opportunity on the same installed Technegas systems. Remember the new era I mentioned at the start? This is it, the era of precision medicine, and here it is in the U.S. opportunity. Because the U.S. has not historically had Technegas, U.S. lung imaging is still predominantly 2D planar. Only about a third of the U.S. departments use SPECT for PE. The new guidelines direct that move to SPECT and SPECT/CT. Outside the U.S., in major markets where Technegas has long been available, we hold more than 85% market share. Each step on this slide adds precision. Function from Technegas, anatomy from low-dose CT, and AI fusing the two down to segment and sub-segmental level, ultimately delivering a data analysis report the clinician can act on.
Technegas is bringing U.S. lung imaging into the new millennium, and every new AI application drives more scans on the same installed system. This is a snapshot of precision medicine and AI ecosystem around Technegas. It is growing fast and getting crowded. Software from Hermes and Siemens to MIM, Thirona, and open-source tools. The list keeps growing, and we work directly with many of these providers. Technegas is not essential to any of them, but every one of them can leverage our pure functional data, and each new platform gives clinicians another way to use it. The value is in the combination. True function from Technegas, plus low-dose CT anatomy analyzed for every patient. Underpinning it all is a moat that is hard to replicate. A U.S. FDA drug device-approved combination made at every point of care.
Every component made by Cyclopharm in-house, delivered direct to the customer without an intermediary, and a razor blade model that drives a proven annuity revenue stream. Let me read it all together. Technegas is the globally recognized choice in lung ventilation imaging, backed by guidelines on four continents now, with more than 85% market share in major markets outside the U.S. The U.S. is now, even in early days, our number one Technegas country market by revenue. The growth is real. Record U.S. revenue, 76% of it from consumable orders, and 44 systems installed in nine months, more than the previous two years combined, and the momentum is building. Committee reviews up 71% within three weeks of Labor Day. 110 systems ready to deploy and more than the USD 1 billion beyond PE opportunity within our broad label.
A proven product, guidelines behind us, real growth, and momentum is building. It is an exciting time to be part of Cyclopharm. We are only getting started. Thank you, and I would be delighted to take your questions.
Thanks, James. As you mentioned, we will move on to the Q&A. As a reminder again to the audience, if you have a question you would like to submit, please do so using the Q&A function within Zoom, and I will jump into those now. James, the first one is alluding to earlier this year, CYC announced a lawsuit. Since then, the person who sent the question, "I cannot recall having heard or read about any update on this development. Can we please get an update on where the matter stands?
Well, as we announced, that lawsuit was taken up by our insurer. It is still before the courts, and that is pretty much all I can comment on. But we are very grateful for our insurer taking on that case.
Thank you. The next question is, "Earlier this month, CYC announced that Technegas is the preferred technology lung agent in China. How many systems has the company installed in China and selling each year, and how many PAS boxes are being sold there?
Yeah. China is an interesting market for us. We have been in the Chinese market for close to 20 years. We have got about 166 units deployed in that market. And what the interesting thing and exciting thing to happen, the way that they were practicing nuclear medicine was very site-specific. These guidelines are an absolute game changer. It is changing the way that China is addressing the practice of nuclear medicine. And their number one recommendation in this lung imaging space, in nuclear medicine, is to use Technegas. Where we see the real opportunity is that now that we are named in these guidelines, we are looking to leverage some of the reimbursement opportunities from there. So we see China as a great opportunity for growth for us going forward.
Next question is, can you expand a little bit on the use of AI alongside Technegas?
Yeah. When you looked at that slide, I talked about precision medicine in the growth. When you look at planar versus where we are today with AI and the hybrid imaging and the new technology, it is trying to compare almost Sputnik to SpaceX. We are at SpaceX, and Technegas is at the heart of that because we show true functional imaging. We give that true, pure dataset that can be analyzed. Not an algorithm, not a manipulation of datasets. We show true function. It is evolving rapidly. The number of companies that are participating in this space, it is quite crowded right now. But we partner with key ones in a lot of our clinical trials or small trials that we participate in expanding the beyond PE applications. We work very closely with some of them.
Thank you. A question that came through during the presentation, how has rest of world revenue increased during Q3?
Well, I made reference to the growth in Q3 over the same period last year. A lot of that is driven by the U.S. growth. But I think one thing that people can take from this presentation is that Cyclopharm is an established revenue-generating company with operations all around the world. And the growth that we are seeing year-on-year, quarter- by- quarter, is a testament to our technology.
And of a similar vein, someone is asking you, provide an update on how installations have progressed to end of October, and what is your current expectation on the number of revenue-generating sites by the end of the year?
We're not going to provide guidance on installations, and we've committed to quarterly updates. The numbers that we've provided you show where the quarter. We actually haven't even seen the benefit of these guidelines yet, other than the information that we provided you about engagement. We're starting to see that flow through in Q3. We're not going to run an ongoing commentary on, unless it's a material update, that will warrant an ASX release.
The next question just again points to the number of U.S. sites signed and in implementation. The question is, how confident are you that these sites will convert into revenue-generating installations? What sort of timeframe should we expect for that conversion?
Well, I think go back to the pipeline numbers. Once it's in contract review, you can count it. While I'm not going to give updates on installations to date in October or where we think we're going to be, I will give you an insight. I just attended the European Association of Nuclear Medicine, and on the plane over, I worked through about six different contracts. Those six different contracts that have moved from committee to contract stage represent just 11 sites of initial installations and reaching another 58 in total. This is the sort of thing that we're talking about, this land and expand. Large institutions signing us up, expanding within their own organizations with the ultimate option of rolling it out to their full complement.
That gives you a little bit of a snapshot of what we're seeing on the back end of these guidelines. The other pleasing thing that we're also seeing is we have a sales force on the ground in the U.S., a great team. We also have in-house sales that is outgoing calls. Because of these guidelines, we're actually seeing an increase in incoming calls, wanting to engage with us, that we might not have had an opportunity to touch upon before.
Thank you. The next question is, do you have an estimate of the average annual revenue per site once the network matures across the full range of sites? And how long does a typical site take to reach that level?
Yeah. The numbers that we've provided previously are actually holding, pleasingly so. So a large site will generate around 70,000 USD per annum. Our average is around that 40,000 to 45,000 USD is what we're seeing. But we have made a concerted effort now, I made mention that we're almost in a quarter of the top 200. Those are our primary focus right now because those are going to give us the largest volume. That's going to be on the higher end, on the 70,000. Now, they often come with some of their smaller institutions, and we sign everyone up. But those numbers are still holding very strong. We have some that are much higher than the 70,000, but on average, it's around that 40,000 to 45,000 USD.
The next question is, how many revenue-generating sites do you estimate are needed for the U.S. business to reach cash flow breakeven? And are you actively exploring other funding options in the meantime?
Look, as I said before, we're not going to provide guidance on installations or breakeven. As a growing company, the board is always looking at our funding positions. It's under regular review, and if anything changes, we of course, with continuous disclosure, we'll let our shareholders know.
Another question that has come through said, "Appreciate that this quarter includes U.S. summer period that you mentioned. Any color on the past four to six weeks given sites are back up and running? Have you seen a reignition on volumes and new contract wins since the end of the quarter?
Yeah.
Therefore, expectations between fourth quarter and third quarter.
I think there is always a lag when you start with the engagement or even in contract discussions. I mentioned earlier that just in the flight over to the European conference, I went through about six different contracts. The numbers are absolutely building. We are seeing incoming engagement as well as those ones that were put on hold when they saw the guidelines come up on their radar. 30 of those moved off on hold. We are seeing absolute movement, and that is only in the first few weeks after the guidelines were in front of everyone post summer holidays.
James McBrayer, that is all the questions. I will throw it back to you to provide a closing comment.
Well, I want to thank everyone for today. It is an exciting time to be with Cyclopharm. The momentum is absolutely there. The engagement that we saw at the recent conference, when I'm catching up with our U.S. teams early in the wee hours of the morning, their afternoons, the opportunities are swamping in.
Great. Thanks, James, and thanks to everyone else for joining.
Thank you.