Q2 2026 Cyclopharm Ltd Earnings Call

September 2, 2026

Speaker #2: Thanks for staying by, and welcome to the Cyclopharm Investor Webinar and Q&A, following the announcement of the company's H1 2026 results. All participants are in listen-only mode.

[Analyst]: Thanks for standing by and welcome to the Cyclopharm Investor Webinar and Q&A following announcement of the company's H1 2026 results. All participants are in listen-only mode. There will be a presentation lasting for approximately 20 minutes, followed by Q&A. If you have a question you would like to submit, please feel free to type it in using the Q&A function within Zoom. Note this session is being recorded. On behalf of Cyclopharm today, we have the CEO and Managing Director, James McBrayer, and I will hand it over to him now.

Operator: Thanks for standing by and welcome to the Cyclopharm Investor Webinar and Q&A following announcement of the company's H1 2026 results. All participants are in listen-only mode. There will be a presentation lasting for approximately 20 minutes, followed by Q&A. If you have a question you would like to submit, please feel free to type it in using the Q&A function within Zoom. Note this session is being recorded. On behalf of Cyclopharm today, we have the CEO and Managing Director, James McBrayer, and I will hand it over to him now.

Speaker #2: There will be a presentation lasting approximately 20 minutes, followed by Q&A. If you have a question you'd like to submit, please feel free to type it in using the Q&A function within Zoom.

Speaker #2: And note, this session is being recorded. On behalf of Cyclopharm today, we have the CEO and Managing Director, James McBrayer, and I'll hand it over to him now.

Speaker #3: Thanks, Matt. I'll just bring up my presentation now. Let's see here. Get my glasses on. Here we go. Great. Well, thank you, everyone, for joining us this morning.

James McBrayer: Thanks, Matt. I will just bring up my presentation now. Let's see here. Get my glasses on. Here we go. Well, thank you everyone for joining us this morning. As I take you through the results of the H1 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, the United States Society of Nuclear Medicine published an international clinical guideline that named Cyclopharm's proprietary product, Technegas, as a preferred ventilation imaging agent of choice. This is our standard disclaimer also, this presentation was released on the ASX last week. What we are going to be doing here? There we go. I will move on to the next. The headlines at a glance.

Speaker #3: 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.

James McBrayer: 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, the United States Society of Nuclear Medicine published an international clinical guideline that named Cyclopharm's proprietary product, Technegas, as a preferred ventilation imaging agent of choice. This is our standard disclaimer also, this presentation was released on the ASX last week. What we are going to be doing here? There we go. I will move on to the next.

Speaker #3: Secondly, the United States has moved from promise to performance. And third, a few weeks after the close of the half, the United States Society of Nuclear Medicine published an international clinical guideline that names Cyclopharm's proprietary product, Technegas, as a preferred ventilation imaging agent of choice.

Speaker #3: This is our standard disclaimer. Also, this presentation was released on the ASX last week. Going here... there we go. I'll move on to the next.

Speaker #3: The headlines at a glance. The top row shows the financial headlines. For the half, revenue was $17.5 million, up 14%. Our fifth consecutive record half.

James McBrayer: The headlines at a glance. The top row are the financial headlines. For the half of the revenue, AUD 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. AUD 12.2 million of cash after a AUD 13.5 million net raise.

James McBrayer: The top row are the financial headlines. For the half of the revenue, AUD 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. AUD 12.2 million of cash after a AUD 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.

Speaker #3: The U.S. Technegas revenue is up 74%. Gross margins are up from 53.5% to 56.3%. Margin improvement is driven by the shift towards higher-margin Technegas, in particular in the U.S.

Speaker #3: Technigas. And $12.2 million of cash after a $13.5 million net raise. The bottom row is driving the top: 83 revenue-generating U.S. locations as of mid-August.

James McBrayer: 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 1/3 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.

Speaker #3: Seventy at 30 June, thirty-five a year ago. 1,684 locations actively engaged in the pipeline, about a third of the addressable U.S. market. And on 29 July, new guidelines naming Technegas, generally preferred when available, were released.

Speaker #3: 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.

James McBrayer: On the loss, AUD 8.8 million against AUD 7.7 million last year, that result is deliberate as a result of our US investment, our R&D nearly doubling to AUD 600,000 as we advance beyond PE indications, and the absence of last year's AUD 1.1 million joint venture profit after we sold the non-core Cyclotech interest. I will come back to cash at the end. A quick snapshot of what we do. This orients 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.

Speaker #3: As a result of our U.S. investment, our R&D nearly doubled to $600,000. As we advance beyond PE indications, and with the absence of last year's $1.1 million joint venture profit after we sold the non-core Cyclotech interest.

Speaker #3: I'll come back to cash at the end. A quick snapshot of what we do to orient 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.

Speaker #3: Technegas is available in 67 countries, with direct distribution in 17 of those. More than 5 million patient procedures have been performed. The number that really matters: in our established markets, Technegas holds a market share of 85% or more in nuclear medicine ventilation imaging.

Speaker #3: 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.

James McBrayer: This is the adoption curve we are now replaying in the United States, the largest healthcare market in the world. We report our revenue in three streams. For the H1, US Technegas grew 74% from AUD 1.2 million to AUD 2.1 million. Rest of the world Technegas increased 13% from AUD 6.4 million to AUD 7.3 million. Third-party distribution was up 4%, delivering AUD 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 AUD 17.5 million, up 14%, our fifth consecutive record revenue half. The point of this slide is not the total, it is the shape. The fastest growing stream is also the highest margin one. In the US, consumables run at greater than 90% gross margin. That is why the group margin moved from 53.5% to 56.3%. This is a slide to remember. US Technegas revenue up 74%.

Speaker #3: For the first half, U.S. 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.

Speaker #3: Third-party distribution was up 4%, delivering $8.1 million in revenue. This was a good result, given that capital projects are intermittent by nature. Again, overall, we posted total revenue of $17.5 million, up 14%.

Speaker #3: 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.

Speaker #3: In the U.S., 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.

Speaker #3: U.S. 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.

James McBrayer: 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 8 weeks between our AGM on 8 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 is a significant expansion runway driven by customers who have 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 are no longer publishing our overall customer list for competitive reasons. However, the statistic speaks volumes.

Speaker #3: Look at the pace—20 new net primary sites in the eight weeks between our AGM on the 8th of May and June 30. The U.S.

Speaker #3: is now ranked number one globally for Technegas consumable revenue, in absolute terms and per installation. And the 83 sites at 12 August are linked to a further 429 contracted affiliated locations.

Speaker #3: That's a significant expansion runway, driven by customers who have already signed, already trained, already decided. For those, no new enterprise network relationship is required.

Speaker #3: Fifty-four percent. This is a number to remember. Fifty-four percent of our revenue-generating U.S. locations are expansion units—a second or subsequent installation inside a customer that already has Technegas.

Speaker #3: We're no longer publishing our overall customer list for competitive reasons. However, the statistics speak volumes. Roughly half of the U.S. News & World Report 20 most acclaimed hospitals in America use Technegas.

James McBrayer: Roughly half of the U.S. 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 are already seeing this benefit. 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.

Speaker #3: All 20 are engaged in our pipeline. Eighteen of the 100 largest U.S. hospitals—27 of the 200 largest, or 13.5%. About 85% of our customer organizations are academic medical centers or major teaching affiliates.

Speaker #3: 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.

Speaker #3: We're already seeing this benefit. Then look at what those institutions do once Technegas is implemented. Eighty-two percent of our revenue-generating locations sit inside multi-location customer groups, and 23 of our 38 U.S.

Speaker #3: 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.

Speaker #3: The expansions we did recently announced tell that story. University hospitals, all 11 sites, now revenue-generating. Penn Medicine, two installations within an 11-site potential. Northwestern Medicine in Chicago, with a 7-site potential.

James McBrayer: 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 have 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 service 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 reputationally slow and undergoes a different approval process to the academic centers.

Speaker #3: 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.

Speaker #3: 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 Technigas story.

Speaker #3: Nine federal locations are now live. Under the October 2024 national contract, we now service six VA hospitals, with a seventh now contracted. Two military hospitals—Walter Reed and Brooke Army Medical Center—and the National Institutes of Health.

Speaker #3: Federal procurement is reputationally slow and undergoes a different approval process than the academic centers. We've successfully proven, given the clinical importance of Technegas, that we can navigate the supply chain and compliance across a government network with 23 distinct procurement groups.

James McBrayer: We have 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 clinical 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 is the detail driving the numbers I have already provided. I will 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.

Speaker #3: Our overall site numbers today are a modest base, but very high in caliber. We are reaching a clinical inflection point, a growing federal network, institutions that are set in clinical practice, the institutions that scale it internally, and that standardize the use of Technigas.

Speaker #3: That is the foundation of our rollout. It's built on the international guidelines—they've just been released—which are the undeniable proof of the clinical importance of Technegas in the U.S.

Speaker #3: This is our U.S. 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.

Speaker #3: 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.

James McBrayer: Third, and pleasingly, since the guideline release, we are reengaging 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 is in contract review, implementation is sure to follow. We are only getting started. This is a snapshot of our addressable market. We are 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.

Speaker #3: 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.

Speaker #3: This is a snapshot of our addressable market. We're data-driven. These are CMS numbers, or actual Medicare claims. The data we mine allows us to see referring and nuclear medicine physicians.

Speaker #3: It also distinguishes pulmonary embolism from other indications. There are 5,139 U.S. locations performing nuclear medicine lung imaging. We regard approximately 2,000 of those as our primary market.

Speaker #3: We expect both the total addressable and targeted market numbers to grow as we expand beyond diagnosing PE. However, PE alone represents a U.S.

Speaker #3: $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 U.S.—the same market share that has already played out in every established market we operate in.

James McBrayer: We have built a strong runway, and we expect to deliver greater than that 85% market share in the US, the same market share that has already played out in every established market we operate. Let us 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 Australia 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.

Speaker #3: 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.

Speaker #3: On July 29, 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—jointly published online in the U.S.

Speaker #3: The Journal of Nuclear Medicine released a new procedure standard for pulmonary scintigraphy, or lung imaging. This was the first update to the U.S. guidance in 14 years.

Speaker #3: It replaces the previous 2012 standard, and it's the first single lung imaging standard that aligns the U.S., Europe, and Australia/New Zealand. Guidelines are the rulebook.

James McBrayer: It replaces the previous 2012 standard, and it is the first single lung imaging standard that aligns the US, Europe, and Australia/New Zealand. Guidelines are the rulebook. 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 is defined in the glossary. It has 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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, Cyclometica, is named as the manufacturer.

Speaker #3: 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.

Speaker #3: First, it calls for a move to three-dimensional imaging in the U.S., where the competing agents are weakest. The second key point is dosing safety. A nuclear medicine scan with Technegas delivers a breast radiation dose up to 70 times lower than a CT pulmonary angiography.

James McBrayer: First, it calls from 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 pre-menopausal 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' 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.

Speaker #3: And about 10 times lower, even with a low-dose CT. The standard names five patient groups where our scans should generally be preferred. They are premenopausal women, pregnant patients, impaired kidney function, contrast intolerance, and suspected chronic PE-related lung disease.

Speaker #3: And the third point, the new guidelines identify AI as a fast-emerging tool and state that Technegas's base data requires no correction. Exactly what our AI collaborators need.

Speaker #3: Until July 29, our U.S. team was asking hospitals to adopt Technigas, a product that was previously listed in the 2012 U.S. guidelines as unapproved for use, and unapproved and unproven in the U.S.

Speaker #3: 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 U.S.

James McBrayer: That barrier has been removed. This is not our marketing claim. It is 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 is the defined standard of care for at least a decade to come. Everything we have built in the US, our existing and imminent installations, our 1,684-location pipeline we have built without this clinical treatise. With it in hand, we are only getting started. So 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 do not get there on marketing.

Speaker #3: 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 U.S.

Speaker #3: Our existing and imminent installations are a 1,684-location pipeline. We've built without this clinical treatise. With it in hand, we're only getting started. So why did the profession update their clinical practice guidelines?

Speaker #3: How do we get to this in viewable position? The answer is twofold. Technology and Technigas. Regarding Technigas, 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.

Speaker #3: 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 July 29 for Technegas in the U.S.

James McBrayer: 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 has not stopped. The next step is already underway. AI and quantification software layered on top of SPECT/CT combination, taking analysis down to segmental and sub-segmental levels. We are seeing a rapidly growing software layer, and all of them need to draw upon that base data.

Speaker #3: Technology is the other driver. Ventilation imaging is in has moved from flat planar images to three-dimensional spec and now to hybrid spec CT that delivers three-dimensional region by region measurement of how each part of the lung is working.

Speaker #3: The new guidelines push the U.S. down exactly that path and identify three-dimensional scanning as the preferred technique. That matters commercially. The more advanced the imaging, the wider the gap between Technegas and the alternatives.

Speaker #3: And the evolution hasn't stopped. The next step is already underway: AI and quantification software layered on top of spec CT, combining analysis down to segmental and subsegmental levels.

Speaker #3: 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.

James McBrayer: 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: It's a fraction of the radiation of a standalone diagnostic CT, let alone a CT pulmonary angiogram. The patient gets both anatomy and function together, and still at a far lower dose.

Speaker #3: 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 are 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.

James McBrayer: The major imaging vendors, the radiotherapy planning vendors, and the open-source community doing lobe 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 have 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.

Speaker #3: 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 a Technegas scan without us spending a dollar on development.

Speaker #3: This whole software layer depends on the quality of the functional input, which is where the unique Technegas particle itself comes in. I've had to give you at least one science slide.

Speaker #3: This is the magic behind Technegas. Technegas's particles are a few nanometers in size—far smaller than a red blood cell and only slightly wider than a strand of DNA.

James McBrayer: 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?

Speaker #3: They behave like a gas going in, spreading 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: It's regulated as a combination product in the U.S. 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 U.S.

Speaker #3: 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.

James McBrayer: 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 3 to 6 months after a clot, where residual blockage carries a 2 to 3-fold 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.

Speaker #3: Technegas measures lung function. Lung function matters in every respiratory condition, not just clots. Beyond PE is an additional addressable market estimated at over $U.S.

Speaker #3: $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.

Speaker #3: 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.

Speaker #3: Every one of those indications already falls inside our existing broad U.S. FDA approval for the visualization of pulmonary ventilation. That's the quote: visualization of pulmonary ventilation.

James McBrayer: 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, but clinicians still need the evidence. We are 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 PROMIS-SPECT 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 revenues up 7.3%, up 13% across our 66 established markets. Third-party distribution contributing AUD 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.

Speaker #3: No further regulatory approval, no delay, no cost. It extends the value of every system already in the field. But clinicians still need the evidence.

Speaker #3: And we're building that case with the latest and best complementary technology, to include AI. Trials continued through the period: the Wilcock Institute study in mild to moderate COPD, and the multi-center PROSPECT trial in France in recurrent venous PE.

Speaker #3: Again, the guidelines note that Technegas base data requires no correction, and it's an ideal input for our AI collaborations. Turning back to our results for the half, the established business supports our U.S.

Speaker #3: Expansion: Rest of the world—Technegas revenues 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.

Speaker #3: 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 U.S. states.

James McBrayer: 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 AUD 13.5 million net with institutional placement and a share purchase plan. At the half, we closed cash at AUD 12.2 million. The statement that matters, we believe we passed peak cash burn. The logic is simple. 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. So as the installed base grows, monthly net cash consumption falls.

Speaker #3: 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 an institutional placement, plus a share purchase plan.

Speaker #3: At the half, we closed cash at $12.2 million. And that's the statement that matters. We believe we've passed peak cash burn. The logic is simple, though.

Speaker #3: Consumable revenue carries a gross margin in the U.S. greater than 90%. Importantly, our commercial infrastructure is already built and is largely fixed. We also have inventory on the ground in the U.S.

Speaker #3: Already there. Each incremental sale needs almost no additional cost, so as the install base grows, monthly net cash consumption falls. Bullets on the left carry our de-risk proposition.

James McBrayer: Bullets on the left carry our de-risk proposition. Reimbursement secured, federal and private network contract 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 are 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 are not buying growth market by market.

Speaker #3: Reimbursement secured. Federal and private network contracts signed. New guidelines published. For any product launching in the U.S., we are in a very unique, even unprecedented, position at this stage of a launch.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: Inside existing customers, then it pulls in its affiliated networks. Eighty-two percent of our installs now sit within the multi-site groups. From there, it radiates. A leading academic center gives us the reference.

Speaker #3: 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.

James McBrayer: We are compounding off institutions we have already earned. Of the 5,139 addressable sites, we target 2,000, and we are only in 83, 4%. The de-risking is done, and we are only getting started. Bringing this all together, there are five key reasons to back Cyclopharm. One, a profitable, growing med tech. The business outside the US is cash positive. We are past peak cash burn, and group gross margins improved 53.5% to 56.3%. Two, we are first in class. 67 countries, over 5 million patient procedures, 85%+ share of the ventilation imaging in our established markets. Now, written into the profession's own clinical standard. Three, US growth is accelerating. 82 revenue-generating sites as at mid-August. A 1,684 location-engaged pipeline. Marquee federal and academic reference sites. A fully deployed commercial team. Now the guidelines. Four, recurring revenue. Roughly, we are generating around US $70,000 a year per larger sites.

Speaker #3: Of the 5,139 addressable sites, we target 2,000, and we're only in 83.4%. The de-risking is done, and we're only getting started. Bringing this all together, there are five key reasons to back the farm.

Speaker #3: First, Cyclopharm is a profitable, growing med tech company. The business outside the U.S. is cash positive. We are past peak cash burn, and group gross margins have improved.

Speaker #3: 53.5% to 56.3%. Two, we're first in class. 67 countries, over 5 million patient procedures, and an 85% plus share of the ventilation imaging in our established markets.

Speaker #3: And now written into the profession's own clinical standard. Third, U.S. growth is accelerating: 83 revenue-generating sites as of mid-August, and a 1,684-location engaged pipeline.

Speaker #3: Marquee federal and academic reference sites. A fully deployed commercial team. And now, the guidelines. Four, recurring revenue. Roughly, we're generating around $70,000 U.S.

Speaker #3: Dollars a year per larger sites. Consumables are greater than 90% gross margin. And five, our real growth is ahead of us. Product expansion beyond P that is accelerated by AA.

James McBrayer: Consumables are greater, that 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 is 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 will report quarterly pipeline updates through the remainder of the year. I want to thank you. I am happy to take questions now.

Speaker #3: All AI, all of these opportunities sit within our existing FDA approval. As I told shareholders at the AGM in May, the U.S. is not a hope.

Speaker #3: 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.

Speaker #3: We'll report quarterly pipeline updates through the remainder of the year. I want to thank you, and I'm happy to take questions now.

Speaker #1: Thanks, James. As you've mentioned, we'll move on to Q&A. As a reminder 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.

[Analyst]: Thanks, James. As you have mentioned, we will move on to Q&A. As a reminder, again, to the audience, if you have a question you would like to submit, please do so by typing it into the Q&A function within Zoom. I will jump to 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 6 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?

Operator: Thanks, James. As you have mentioned, we will move on to Q&A. As a reminder, again, to the audience, if you have a question you would like to submit, please do so by typing it into the Q&A function within Zoom. I will jump to 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 6 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?

Speaker #1: And I'll jump into those now. The first one I have came through via email, James. There is a feeling in the market that the company will need to have a further capital raise in the next 6 to 12 months. To help alleviate this concern—

Speaker #1: Can you please speak to the cash position, burn rate, and how this will reduce as projected installations occur?

Speaker #2: Yes, thank you for that question. At the end of the half, we've reached $12.2 million, as mentioned in the presentation. We have reached cash burn peak.

James McBrayer: Yes. Thank you for the question. At the end of the half, we had reached AUD 12.2 million, as I mentioned in the presentation. We have reached cash burn peak. Every installation in the US generates high margin, and with every installation. The board has no immediate plans for any type of capital raise, but we are always looking at opportunities that avail themselves.

Speaker #2: Every installation in the U.S. generates high margin, and 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.

[Analyst]: Thank you. The next question is, will the company look at paying a dividend anytime soon?

Operator: Thank you. The next question is, will the company look at paying a dividend anytime soon?

Speaker #1: Thank you. The next question is: Will the company look at paying a dividend any time soon?

Speaker #2: We know that that's very important for our shareholders. Historically, we pay dividends. Once the U.S. is firing, it's going to be very cash generative, and we will be reintroducing a dividend at that time.

James McBrayer: We know that that is very important for our shareholders. Historically, we pay dividends. Once the US is firing, it is going to be very cash generative, and we will be reintroducing a dividend at that time.

Speaker #1: And there's been a couple of questions come through just with regards to break-even point. So can you just maybe speak to what needs to happen for the company to reach that point?

[Analyst]: There has been a couple of questions come through just with regards to break-even point. Can you just maybe speak to what needs to happen for the company to reach that point?

Operator: There has been a couple of questions come through just with regards to break-even point. Can you just maybe speak to what needs to happen for the company to reach that point?

Speaker #2: Well, I think we talked about the benefit of the U.S. and the margins that we're driving. There are a couple of different drivers in that.

James McBrayer: Well, I think we talked about the benefit of the US and the margins that we are driving. There is a couple of different drivers in that. We are dealing with large contracts. Those tend to fall into place with large institutions generating over US $70,000 per annum. The speed at which that we generate, of course, is going to bring us to profitability that much sooner. We are delivering on that, and the speed in which we are driving that on the back of these guidelines. We are expecting great things.

Speaker #2: You know, we're dealing with large contracts. Those tend to fall into place, with large institutions generating over $70,000 U.S. per annum. The speed at which we generate, of course, is going to bring us to profitability that much sooner.

Speaker #2: So we're delivering on that, and the speed at which we're driving that on the back of these guidelines—we're expecting great things.

Speaker #1: Thank you. The next question I have is, how does your third-party distribution business work? Can you speak to key partners, the profitability of this, and the scope for growth?

[Analyst]: 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?

Operator: 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?

Speaker #2: Yeah, I mean, I think I'll start with the reason behind that. I mean, we're in 67 countries around the world. We're direct in 17 of those, meaning that we have our own service, sales, and regulatory support in those.

James McBrayer: Yeah. I think I will start with the reason behind that. We are in 67 countries around the world. We are in direct in 17 of those, meaning that we have our own service, sales, and regulatory support in that. That is 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 has 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, and we have seen a great demand because typically distributors do not care about your product as much as you do. We have turned that around, and we have 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.

Speaker #2: That's a very unique and valuable asset—an asset that companies much larger than ourselves are leveraging because we can deliver those aspects. It's become, you know, from a standing start in 2020, a significant contributor.

Speaker #2: And it adds to, you know, the overall profitability of the company. We continue to add and discuss with third-party players to represent their products.

Speaker #2: And, you know, we've seen a great demand because, you know, typically, distributors don't care about your product as much as you do. We've turned that around.

Speaker #2: 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.

Speaker #2: Those can be lumpy in revenue, but we have that ongoing consumable—the razor/razor blade model—like Technegas that drives that. So we're going to continue to expand that in our existing markets.

James McBrayer: Those can be lumpy in revenue, but we have that ongoing consumable, the razor blade model like Technegas that drives that. We are going to continue to expand that in our existing markets.

Speaker #1: 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?

[Analyst]: 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?

Operator: 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?

Speaker #2: So, 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 U.S.

James McBrayer: It is in the presentation. We have been very transparent about our pipeline. We will 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 has already grown and will continue to grow. We will be giving those updates periodically. I think I will kind of back up. In the way that we present the numbers in the pipeline, the primary sites are the ones who were actively engaged in saying that they are 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.

Speaker #2: That's already grown, and it will continue to grow. We'll be giving those updates periodically. I think I'll kind of back up—and in the way that we present the numbers in the pipeline, the primary sites are the ones that we're actively engaged with, saying that they're going to start with the Technegas systems.

Speaker #2: The affiliates are an important part, and that goes back to that 54% number. Once we get an established site, it grows from there.

Speaker #2: And so 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 U.S.

James McBrayer: Even conversations I have had with the team in the US this morning, we are starting to see some growth even in our existing base today. The numbers are in there. It is in the table. Track us on that. That is showing the growth. We are 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 have welcomed the guidelines that came during the summer, we are hitting the ground very hard with the guideline starting next week.

Speaker #2: This morning, we're starting to see some growth even in our existing base today. So the numbers are in there—it's in the table. And, you know, track us on that.

Speaker #2: 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.

Speaker #2: So while we've welcomed the guidelines, they came during the summer. So we're hitting the ground very hard with the guidelines, starting next week.

Speaker #1: The next question I have is: Are you subject to U.S. tariffs? And if so, have you raised prices?

[Analyst]: The next question I have is: are you subject to US tariffs, and if so, have you raised prices?

Operator: The next question I have is: are you subject to US tariffs, and if so, have you raised prices?

Speaker #2: So, you know, we're in an enviable position right now in that, you know, unlike a lot of producers shipping into the U.S., we're the manufacturer.

James McBrayer: We are in an enviable position right now in that we are unlike a lot of producers shipping into the US. We are the manufacturer, we are the exporter, we are the importer, and then we are the distributor. We have our hands on a lot of levers. We have also had a stock buildup in the US before some of these tariffs. We have not taken that for granted. We have engaged at multiple levels in both the US and here in Australia. At present, we have a small tariff on there. But again, this is based on transfer pricing into the US. But we are watching that very closely. As you know, it is a dynamic landscape.

Speaker #2: We're the exporter, we're the importer, and then we're the distributor. So we have our hands on a lot of levers. We've also had a stock buildup in the U.S.

Speaker #2: before some of these tariffs. We haven't taken that for granted. We've engaged at multiple levels in both the U.S. and here in Australia.

Speaker #2: At present, we have a small tariff on that. But again, this is based on transfer pricing into the U.S. We're watching that very, very closely. As you know, it's a dynamic landscape.

Speaker #1: Thanks, Shai. 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.

[Analyst]: Thanks, James. That is all the questions that have come through. I will just throw it back to you to provide a closing comment if you like.

Operator: Thanks, James. That is all the questions that have come through. I will just throw it back to you to provide a closing comment if you like.

Speaker #2: Well, I think I summed it up at the very end when we talked about the deliverables, and you know, we're in a very, very unique position for any company.

James McBrayer: Well, I think I summed it up at the very end when we talked about the deliverables and we are in a 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 is who of who you want to have your product in. We are starting to see that all the work that we have been putting in, all of the work that we have had with reimbursement, setting these lighthouse sites up and running, we are starting to see the momentum picking up, and it is going to be an exciting time.

Speaker #2: You know, we consider ourselves still in the launch phase in the U.S. Launching with an international guideline—U.S.-based—that names your product by name as the agent of choice.

Speaker #2: We have some of the leading institutions in the U.S.—a who's who of where you want to have your product in. We're starting to see that all the work that we've been putting in—all of the work that we've done with reimbursement, getting these lighthouse sites up and running—we're starting to see the momentum picking up.

Speaker #2: And it's going to be an exciting time.

Speaker #1: Thanks, Shai. And thanks to everyone for joining. And we'll look forward to bringing you more news soon.

[Analyst]: Thanks, James, and thanks to everyone for joining, and we will look forward to bringing you more news soon.

Operator: Thanks, James, and thanks to everyone for joining, and we will look forward to bringing you more news soon.

Speaker #2: Thank you all.

James McBrayer: Thank you all.

Operator: Goodbye

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Q2 2026 Cyclopharm Ltd Earnings Call

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