OncoSil Medical Limited (OSL) Earnings Call Transcript & Summary

Good afternoon, everybody, and thanks very much for joining this investor webinar. Very excited to be able to speak to you today and update you on our progress concerning our FDA approval that we just received. Next slide, please. So the OncoSil device has received the U.S. Humanitarian Device Exemption approval from FDA for the treatment of distal cholangiocarcinoma. So we've been granted a Humanitarian Device Exemption approval. It's an FDA approval that completes our regulatory HDE process and provides U.S. marketing authorization for the OncoSil device. The OncoSil device, it's important to point out, is the first and only U.S. FDA-approved Class III device for the treatment of dCCA or commonly known as distal cholangiocarcinoma or bile duct cancer. So OncoSil is now in the position to commence a focused U.S. commercialization strategy, and we'll be targeting leading academic cancer centers and specialist hepatobiliary teams with the U.S. launch expected in the second half of 2027. We'll get into that a little further in the presentation. The next slide, please, Shelley. What is distal cholangiocarcinoma or dCCA? Patients who have dCCA have a very poor prognosis. The treatment options are extremely limited and there is poor survival associated with this prognosis. So dCCA develops as a cancerous tumor in the common bile duct within the head of the pancreas. Clinical symptoms of the disease are not really evident, I should say, until the tumor has developed to a point that it's rather difficult for the surgeon to remove it. More than 50% of patients who develop dCCA cannot have the tumor removed surgically. The tumor is deemed to be unresectable. So unresected non-metastatic dCCA is associated with a poor prognosis with median overall survival at just 6.7 months, while the incidence has been reported to be growing at about 1.4% annually. Treatments for unresectable tumors involve placement of a stent, chemotherapy, external beam radiation or a combination of the two. Side effects due to chemotherapy and radiotherapy are considerable and have a very negative impact on the quality of life for the patient. OncoSil has shown promise for dCCA and is the basis for the HDE approval granted by FDA. The advantage of OncoSil here is the ability to deliver a high dose of radiation to the target dCCA tumor with minimal side effects. Next slide, please. What does the treatment pathway for unresectable dCCA look like and what is the impact on the patient's quality of life? So dCCA disease course has a negative impact on quality of life for the patient. Most of these patients have a stent implanted. The challenge, therefore, for clinicians is to maintain the patency of the common bile duct. Invariably, the stent occludes within about 4 to 6 months due to the development of the tumor. This results in significant complications, including extreme abdominal pain, cholangitis, which is inflammation and infection, which necessitates admission to hospital. These patients, by the way, are continually facing readmission to hospital. This means an interruption of their chemotherapy, possible surgery to replace the stent and reopen the bile duct, administration of antibiotics to control the infection. As the disease continues to progress, subsequent reocclusion of the stent and repeated admissions occurs. So there are repeated admissions to the hospital. These patients don't normally succumb to the primary disease, which is the dCCA. They succumb to sepsis, which is systemic infection and liver or multi-organ failure. So to conclude with this slide, OncoSil has the potential to control local tumor development, which is important, and maintain bile duct patency, which leads to an increased quality of life and therefore, extended survival. Next slide, please, Shelley. So in terms of the HDE, what are we doing in terms of accelerating U.S. market access for OncoSil in this indication? What is the HDE pathway? It's designed for diseases or targeting diseases of fewer than 8,000 individuals on an annual basis. It permits approval based on probable benefit outweighing risk to the patient rather than requiring the extensive clinical evidence of a costly Phase III randomized trial, which is what we would need for a PMA or premarket approval. This provides shortened access to market with a cost-efficient route. So why is the HDE particularly relevant for OncoSil in distal cholangiocarcinoma? Number one, it's a very rare and highly aggressive cancer with extremely limited treatment options and a very poor prognosis. So there is a high unmet medical need in this patient population. Under the approval, OncoSil Medical is authorized to commercially market and sell the OncoSil device in the United States. What is the strategic benefits of the company? It is a reduced clinical development burden and cost. We don't have to do a randomized trial via its route. It's earlier U.S. commercial entry opportunity for us. The reimbursement in the United States is homogenous. There are shorter regulatory time lines versus a traditional PMA. It's the ability for us to generate real-world evidence and physician adoption post approval and it establishes us in the U.S. market, which is a high value -- with a high-value oncology indication. Next slide, please. What is the dCCA patient population? What does it represent to the company? Well, it represents an annual AUD 80 million addressable market. So if we look at the numbers and how they break down, the annual incidence of U.S. cholangiocarcinoma patients is about 8,000. dCCA represents 30% to 40% of the 8,000 or numbers -- ease of number purposes and calculations here, we've chosen 35%, [ 2,800 ] dCCA patients. So unresected non-metastatic dCCA accounts for approximately 33% of the 2,800, which represents about 1,000 patients. The assumed average selling price per patient is USD 55,000, and this translates into a TAM or total addressable market of AUD 80 million per annum. It's important to point out here that the median overall survival in unresected non-metastatic patients is about 6.7 months, and that's quite a dismal prognosis for these patients. I've already mentioned that the annual increase is about 1.4%. On to the next slide, Shelley. So the HDE approval opens up a new treatment pathway for patients in the U.S. with dCCA. This is the FDA-approved [indiscernible] the HDE pathway for dCCA. OncoSil is intended for intratumoral placement into a solid tumor via injection under endoscopic ultrasound guidance. OncoSil is indicated for the treatment of patients with distal cholangiocarcinoma that is both unresectable, in parenthesis, locally advanced and/or unfit for surgery, and non-metastatic as an adjunct to systemic therapy. OncoSil is indicated for the treatment of patients over 21 years of age. Implantable components of OncoSil are supplied sterile and are intended for single-patient, single-use. That is the official way to do. Next slide, please. So together with the approval, we are required to perform a study in distal cholangiocarcinoma patients. So this is a post-approval study or PAS, as we'll refer to commonly in any subsequent communication out to the market. So what does it look like? The study design is multicenter. It will involve five sites. It's observational. It will be 30 patients. It's prospective. A 24-month follow-up. So the objective of the study is to evaluate the safety and probable benefit of OncoSil in patients with dCCA that is both unresectable, locally advanced and/or unfreed surgery, and nonmetastatic as an adjunctive chemotherapy. One of the outcomes that will be assessed in this trial, overall survival, safety and tolerability, which is why we have the HDE, implantation performance, biliary patency because, as I mentioned earlier, keeping the common bile duct patent is a huge challenge for physicians. Local disease control/progression, target tumor response, progression-free survival, local progression-free survival, surgical resection rates and outcomes. So the initial commercial revenue for OncoSil for the 30 patients is approximately USD 1.7 million. Next slide, please, Shelley. So OncoSil at the moment is focused on a U.S. commercialization strategy and market launch. So the pathway -- what is the pathway to a targeted U.S. launch of the OncoSil device in the second half of financial year 2027? So priority is to first activate priority treatment centers. That's priority number one, and that is a focus on leading academic centers that have established dCCA and hepatobiliary oncology expertise. We will activate priority treatment sites ahead of the planned U.S. launch. So we can start the training any time. We will have to get IRB approval from each of the centers. This is not something that happens sequentially. It's something that happens in parallel. We will build a concentrated initial footprint, supported by a small U.S. focused team. And it's really designed to support high-quality execution and early adoption of the technology. There are low capital requirements under this initial commercial model. So we need to build clinical advocacy and launch readiness. So we have to engage the key opinion leaders and multidisciplinary clinician teams to support clinical adoption, which also means that we'll have to support around the tertiary centers that will be performing the treatment. We'll have to get the word out to other institutions within that area that may have patients, I guess, participate in the study. So we'd like this to recruit as quickly as possible. We need to enhance clinician education and treatment so the teams are prepared to commence at launch. And we have to leverage early center experience, build confidence, efficacy and referral momentum. Again, that would also refer to making connections at institutions beyond the tertiary centers that will be involved in prosecuting the PAS or the post-approval study. So in order to drive access and drive adoption, we will submit an application for the traditional pass-through payment status in Q1 of financial 2026. And this will advance market access pathways to facilitate patient access to the treatment. This means that we will get a dedicated code for the OncoSil device because we are the only device of its kind now in the market, [ and we ] need our own code. So we will deploy targeted physician, patient and referral initiatives to build awareness and support patient identification. We will work through coordinated market access to drive adoption, education and focused commercial execution. So when I say also that we're driving patient referral initiatives, this includes working very closely with the Cholangiocarcinoma Foundation. They're a very active group in supporting these patients in the United States, highly organized and very well respected within the medical community. So the commercial objective then is to establish a high-quality early U.S. center network, remove any barriers to access and create a scalable platform for broader adoption once we finish the 30 patients.

I will just add, Nigel, on top of that, there is a typographical error. It is, of course, Q1 of FY '27, not FY '26.

Thanks, Tom, for pointing that out. So in summary, FDA granted us the HDE approval. That was on August 14, 2026, U.S. Eastern Standard Time, which for you folks, it was plus 14 hours. So that was the time that we received the letter. The approval completes the HDE regulatory process for OncoSil and provides U.S. marketing authorization for the approved indication. So now we have a commercial authorization and market opportunity, which we've stated already is roughly 1,000 patients, representing an estimated AUD 80 million total addressable market. And this significantly broadens the commercial opportunity for the OncoSil platform. U.S. commercialization will commence focused commercialization strategy targeting, again, leading cancer centers. We are limited to five. I just want to reiterate that until the post-approval study is complete. OncoSil is expected to launch in the U.S. during the second half of FY '27. Next slide, please. So what's the current outlook? What are the upcoming milestones? So in the first half of financial 2027, we have the U.S. device labeling filing. We will need to -- obviously, there are some discussions that will go on for the finalization of the post-approval study. We've had the presentation of the clinical results at ESMO GI. We've completed the validation of the manufacturing facility at Cyclotek. We've been pulled into the PALACROS and agreed to participate in the PALACROS European consortium. Our area of focus is specifically the PULSE trial [ for LAPC ]. The product being used up to 3 times in these patients with unresectable locally advanced pancreatic cancer. So we have the HDE approval now for distal cholangiocarcinoma. ISO certification is -- we expect that to be received imminently by Cyclotek. We expect the G-BA funded study commencement. Of course, this is now in the summer months. So we're just waiting to hear back until it's published in the Federal Gazette in Germany, which means the study can start. The transitional payment application will be submitted in this first quarter financial year '27, and that's to ensure reimbursement with a dedicated code that allows hospitals to bill against that specific code. A lot of procedural codes are already in existence. So there's nothing we have to do there except map out the payment pathway for each hospital so that they maximize on the reimbursement opportunity. So the EU regulatory submission is currently being analyzed, and we expect to be able to submit for the percutaneous label change as a result of the completion of PANCOSIL study. and the EU regulatory submission for FOLFIRINOX. Again, that study is completed, as everyone on this call may know, and we will be preparing that dossier to submit to the regulator as well in Europe. And commercial sales from the OncoSil Cyclotek facility in Sydney is something that we anticipate happening sometime early next year. What is the outlook for the second half of financial 2027? So we expect the percutaneous label change approval, the approval for FOLFIRINOX label change, both of those within the EU. We will launch the device in Australia at selected institutions. And then, of course, importantly, we will launch the device in the United States. Next slide. Now I'll now open the floor to questions, and we'll be able to provide some answers for you. And before I go any further, my sincere apologies, I wanted to introduce at the beginning, but jumped right into the presentation. I have two team members on the call, Tom Duthy, who is our Chairman. Apologies, Tom. And Shelley Steyn, or Steyn rather, who is our Chief Financial Officer, have joined for this webinar. So sincere apologies for neglecting to introduce you at the beginning.

Thank you, Nigel. We did receive a couple of questions. Now FDA approval is secured, what are the key milestones from the initial five centers, 30-patient post-approval study to broader U.S. rollout? And what is the main gating factor to meaningful revenue? Is it reimbursement, center activation or the PAS progress?

I can definitely tell you it's not reimbursement. We need to get the 30-patient post-approval study done first. And then that is something that the FDA removes that restriction and we're no longer limited to five institutions. We're no longer limited to treating 30 patients. That is the gate opener to the larger market, is the completion of that post-approval study and then letting us go forward and open up other institutions.

Thank you. Another one, is there a high cost associated with your U.S. launch plan under the HDE?

Actually, no. There isn't a high cost because, again, we're in five centers. So it's not going to be a labor-intensive exercise. We don't have to hire a lot of people that need to go all over the country. The centers are situated -- the intended centers, I should say, geographically situated so that we can provide the access for the patients. A lot of these patients, let's not forget, will need to travel to these centers. They don't exist everywhere in the United States, but they -- patients will need to travel. So we've chosen centers that are geographically well situated, making it easier for patients to access these centers to obtain the treatment. But it's not a capital-intensive exercise to build a team to service five centers and recruit 30 patients.

What specifically needs to happen before the U.S. revenue is generated? And why is the commercial launch expected in the second half of FY '27 if approval has already been received?

Okay. So the next step, as I mentioned, is the transitional payment pass-through process. So we'll be submitting that application in the current quarter. That enables us to use this dedicated code to be able to bill for the treatment. So it's important to note that sites in the U.S. are very much for-profit irrespective of whether they're academic sites or not. And we don't want to be in a position where sites come back to us and say, sorry, but our reimbursement has been denied. So our job right now, and it starts -- it started immediately, actually, and we've already got about 80% of this application complete. So now that we have the letter from FDA, we can complete this application, submit it. And we anticipate that we should get this around the beginning of January where we have a dedicated code that will be used to bill for the treatment itself, the cost of the dose.

Thank you. Can you clarify the FDA's five-center restriction during the post-approval study commercial -- sorry, it's a bit small. Can you clarify the FDA's five-center restriction during the post-approval study? Are commercial treatments limited to 30 enrolled patients in the study? Can those centers treat additional eligible patients? And what milestone allows OncoSil to expand beyond five centers? Is it completion of enrollment, an interim FDA review or the full 24-month follow-up?