Cochlear Limited (ASX:COH)
Australia flag Australia · Delayed Price · Currency is AUD
93.00
-2.25 (-2.36%)
Apr 28, 2026, 4:11 PM AEST
← View all transcripts

CMD 2023

Oct 26, 2023

Dig Howitt
CEO & President, Cochlear Limited

Okay, good morning, everyone, and thank you for joining either here at Cochlear or online. Great to be able to have another one of our Capital Markets Day. With COVID, it's been a little while, but it's certainly good to be back here. So today, I want to start with an acknowledgement of country before we get into the detail of the presentation. So on behalf of Cochlear, it is a pleasure to acknowledge the Wallumattagal people of the Dharug Nation, who are the traditional custodians of the Macquarie Park area, and we pay respects to elders both past and present, and to leaders emerging. We always start presentations with our mission, because our mission guides us. It's clearly the purpose of the company.

It guides us in terms of the outcomes we want to achieve, but also guides our strategy. Hopefully, as we go through the strategy today, you can see clear links to each of the parts of our mission that we have here. Today, I'm gonna start with an overview of corporate strategy. I'm gonna do that pretty quickly. You'll see the slides actually have quite a lot of detail on them, so you can take them away and read them. I'm not gonna go through that detail. I'm gonna keep quite high level. Because I think better today to hear from Jan, Dean, Lisa, Greg, and also with Jan, we have Adi and Roger, who will be presenting parts of our technology. For afterwards, too, we have all of our executives team here and other members of Cochlear.

So it's a chance to, over lunch, to talk to us a bit more, and we have some manufacturing tours there as well. Between each of the sessions, we'll have time for Q&A. You know, if that's sort of going too long, I'll jump in and, say, "Let's hold till the end," 'cause we do have time at the end to have more detailed questions. But let's get started. So I'm gonna spend a bit of time on our growth opportunity, leading into the strategy, and then I said move quite quickly through the strategy so you can hear more from, the other executives in more depth. But underpinning our strategy is this enormous growth opportunity that we have, and there's five aspects to why do we have such a significant growth opportunity?

The first of those is hearing loss is prevalent, one of the most prevalent medical conditions, and way undertreated, one of the least treated in the world as well. So that creates enormous opportunity, not just for hearing implants, but actually for all forms of hearing solution. In our segment, in implant segment, cochlear implants are cost effective for all age groups, and there is more and more data emerging to show how cost effective they are. It's, it's sort of blindingly obvious for children. Now, there is very good data for adults and for seniors on the cost effectiveness, and that obviously supports reimbursement and supports healthcare budgets allocating money towards hearing care. We think about hearing aids or implants. When we get into indications for implant, and those indications are expanding, implants give a significantly better hearing outcome.

So that again underpins the huge opportunity. But despite that, opportunity, we've only got about 4%, maybe 5% penetration of people within indications. Again, that underpins the potential for long-term growth. And indications are expanding, and that's a recognition of the improvement in outcomes, and just growing recognition of the need to treat hearing loss because of the consequences, other health consequences, economic consequences of not treating. And then finally, good hearing, an essential part of healthy aging, and obviously, that's very clearly, closely linked to indication expansion of funding. And we'll talk more about that as we go through today. So those are the five pieces that sort of really underpin the growth opportunity for us. Then, we think about the growth opportunity, we think about it, we segment the market. We think about it in four segments.

Children in the developed markets, which we talked a lot about, over time, very high penetration. Obviously, significant lifetime value, significant for recipients, for children, to be able to hear versus not being able to hear. High penetration means we don't need to invest too much in driving awareness there. There's already a standard of care. Children in emerging markets, the reason to act is as compelling as it is for children in developed markets. What's needed is awareness, infrastructure, training, or we, in our emerging market strategy, we work to provide those things and do so in a paced manner, because of the need for the whole lifetime care. Can't just do surgery. We've got to make sure the aftercare is in place, so that paces the rate of our investment and rate of growth.

And also, seniors in developed market is the one we talk most about. It is the biggest opportunity for growth for us over at least the next 10 years. There are far more adults and seniors with hearing loss than there are children, significantly more, but the penetration, and we'll talk to that, is very low. So that's the core of our strategy, and where particularly Dean and Lisa today will spend most of their time, is talking about what are we doing to activate that segment. And then acoustic implants. So acoustic implants are really important opportunity for us, and we'll talk a bit more about that as we go. Okay, so our strategy, we set out our strategy across 5 pillars where of way, in ways we can create value.

For each of those, we've got targets, we're clear on the stakeholders and on the benefits we deliver. So as I step through the presentation, gonna do it in terms of those five pillars, starting with a healthier and more productive society. This is where Dean and Lisa will spend most of their time talking today, so I'm gonna move through this quickly. But the structure here, you can see what are our priorities, what's our target, and who benefits and how do they benefit? And then, again, linking back to how do we create value for all stakeholders. So getting referrals for adults and seniors, Lisa and Dean will talk to this about developing standard of care, so I'm gonna move quickly through it.

And we have Adi Nilson, who's our Vice President for Acoustics, product portfolio with us today, gonna talk about Osia. What I do wanna say on acoustic implants is we have a huge opportunity here, and I think we're going about it the right way. If you go back to the start of Cochlear in the early 1980s, one of the things, couple of things that the company got right, the people in the company got right at the time, were the technology choices. And that technology choice of a titanium implant and a system that used low power, enabled us to lead the market early, which enabled us to invest in the development of the market. If we look at acoustic implants, we've shipped over 750,000 implants in total over our history.

A couple hundred thousand Baha implants, only 12,000 Osia implants in that total, but we got the technology right. And we have made a different choice to our competitors here, and Adi's gonna talk to this, but the piezoelectric technology gives us 3 Tesla MRI compatibility. It also gives us higher power output at higher frequencies. Those two things we think are an unmatchable competitive advantage. So same as 40 years ago with cochlear implants, I think we got the technology right to enable us to lead and invest in growing the acoustic implant market, which is a huge long-run opportunity. Reimbursements and indication, clearly critical. You can see in the pack changes each year, we are working hard at this right around the world.

It's a critical piece of the strategy, and we take small steps in a lot of places over time, but all of that builds to more awareness, more funding, and Jan will talk about why those indications are broadening. Emerging markets, we're not gonna talk about today, but as I said earlier, it's 20% of our revenue comes from emerging markets. It's also been, in terms of the number of implants, a good area of growth. There's significant opportunity, about 10% penetrated for children in emerging markets at the moment.

But we know the steps to take, and we're pacing our investment in the steps that we need to take to grow those markets around awareness, building funding, building our presence, people on the ground, and making sure the professional capability and the infrastructure are in place to give good outcomes, 'cause it's good outcomes that lead to repeat funding, obviously. So on from emerging markets, so that's the first of the pillars. Second of the pillars, a lifetime of hearing solutions, and Jan is gonna talk in depth about about this, but it's clearly two parts. It's making sure we have technology leadership, a leading product portfolio, and delivering the customer service and experience that our customers expect. Those two things give us the market leadership and give us the other access to more more patients over time.

So our investment in R&D has been significant and consistent over a very long period of time, and that enables us to have the portfolio that we do. It also means that we invest, and Jan will talk to this, across the entire portfolio. Why is that important? It's important because what people receive, what, o ur customers, obviously, want is hearing. They get that through the entirety of the system and the professional experience that delivers those hearing outcomes and convenience. So by investing in the entire system, we both improve hearing outcomes, we improve the convenience of getting care, and we lower the cost of care. So it's only through doing all of those things, investing across the whole system, can we deliver that holistic outcome, which we see as key to our market position, but also key to market growth.

As part of that investment is the ability to offer upgraded technology to our growing recipient base. So over 48,000 people upgraded technology last year. That was lifted by Nucleus 8, and you'll hear more on Nucleus 8 this morning. And service and support, and part of that is Connected Care, and Jan is gonna talk to our Connected Care solutions as we go through today. But really three pieces to, or three outcomes we're looking for Connected Care. The first of all is this convenience in care and the creation of capacity. The second one is to reduce costs. Again, as we compete for a larger part of healthcare budgets, as we grow, we need to demonstrate that we're doing that efficiently, and part of that is taking costs out of the system.

Connected care is an opportunity to do that. And we start to generate a lot of data from our customers, from the Connected Care solutions, which we think we'll be able to use for them to get better outcomes and to give us insights into future product development and better ways to streamline care and deliver better hearing outcomes into the future. And very importantly, obviously, with the implant is the reliability. And again, the choice of a titanium implant, back in the early 1980s, by Cochlear, was critical to underpinning our reliability, which enabled us to continue to invest in market growth.

So 22M there, which is the, you can see on the chart with, at 35 years, 90.49% reliability, is a sign of the great technology decisions that were made early on and the care taken in manufacturing. And there you can see each generation of implant gets more reliable. At the time, we're very rigorous in the reporting of our reliability. There's standards that we rigorously adhere to. We also report all of our generations of implant, whether they are on the market or not. And Greg will talk later to some of the aspects of ensuring quality in our manufacturing process, 'cause that link to it between R&D and manufacturing and the quality controls in manufacturing, which underpin the long-term reliability of our implants. Okay, on to, on to people.

As a technology company and a company that is very dependent on good, strong, professional relationships, our people are absolutely critical to our success. And hence, a lot of attention and investment on our part in making sure that we have the best people, and that we have a culture which enables those people to thrive and deliver for our customers. So significant amount of work on our culture and on talent. And just a couple of aspects of that is really thinking about enterprise leadership. So again, as our customers want and demand more integrated and streamlined solutions, whether professional customers or recipients, we need to make sure our organization is well connected globally to deliver that. And that is fundamentally about culture, how people work together and interact around the world.

So we spent a lot of time working on our culture. We measure that in part through anecdotes and in part through our engagement survey. And our engagement is at 80%. It's been at 80% for several years, and when we look under, w e're very happy with it being at 80%. When we look underneath that, we see more indicators of our culture. And one of the ones that stand out is that 94% of people understand how they contribute to the satisfaction of our customers. And that's when you think about a lot of our employees in Australia, most of our customers are outside of Australia, but people still see that very direct connection.

That speaks to our mission and elements of our culture that actually drive us to continue to do better in terms of servicing customers. And pretty clearly, in having that culture, it enables us to attract the very best people to work for Cochlear. Lots of examples I could give for that. One is just the number of engineering applications we get from graduate engineers. And it's actually, I forget the exact number, I think it's heading for somewhere between 10%-20% of all graduating engineers in Australia want to come and work here.

So it's a, you know, that on its own is a significant indicator of what the opportunity we provide and the sort of access to talent that we have, and advantage of being in Australia, frankly, from an engineering perspective, is to be able to attract people like that. And clearly, we have that sort of similar level of talent around the world. But an important part of attracting that level of talent is to make sure that we have a very diverse and inclusive culture. Clearly, our customer base is incredibly diverse, with customers in 180 countries around the world. We are trying to reflect that within the organization.

And, there are a number of ways in which we do that, in terms of sort of broad aspects and, and dimensions to diversity and inclusion. One of the ones that is the most measurable and most focused on is gender diversity, and we've made some pretty significant process there, progress there over the last several years. Then, all the statistics there, the key one for me is, or for us, sorry, is senior placements. If we get senior placements at 50/50, we will end up with proper gender diversity across all levels of the organization, and we're making good progress on that front. Okay, environmental responsibility. We need to do this. We are a small carbon emitter. We have a small environmental footprint, but we still need to improve it.

So we are working through our Scope 1, 2, and 3 emissions. We've quantified Scopes 1 and 2. Most of that comes from our manufacturing sites. Through energy consumption, we've converted them over to renewable energy, now 96% converted to renewable energy. That's led to a significant reduction already in our Scope 1 and 2 emissions. We are at the moment quantifying Scope 3 emissions. We think the biggest part of that is air travel, not surprising for a global company, and we've committed to reduce carbon emissions from air travel, both by reducing travel, per person across the company, and buying offsets, because there is no other way to reduce carbon emissions from travel at this stage, buying offsets to reduce that impact as well.

And then finally, on to sustained value, and a couple of parts to this. Obviously, our financial returns and how we go and conduct business. We have a very long track record of growth, and these charts are on our website. They're in the annual report. Long-term history of growth in implants, of revenue growth, of investment in R&D and in OpEx, and consequently, that flowing through to profit and dividend. And given the growth opportunity, we obviously expect that to continue, but know that we need to invest and keep investing to get that opportunity. That's why we've been really clear on the P&L that we were aiming to get 10% top line growth. Obviously, it's not gonna be like that every, you know, it'll move around a bit, but that's our long run growth.

We've been growing faster than that, actually, more recently. Committing to 12% of sales into R&D, a gross margin of 75%, and a net profit margin after tax of 18%. I often get asked, can we get leverage? Yes, we can, and we do, and we reinvest it. And way to think about that is you'll hear from Dean and Lisa, we are investing significantly in building awareness and building access for adults and seniors. The way we think about that is that we're building an asset, and we want to invest in that as much as we can in that asset, while maintaining a level of profitability. When we've got 5% penetration, it clearly makes. And we've got a great product, it clearly makes sense to make that investment.

As that asset's built, we'd hope at some point in time, the maintenance CapEx or the maintenance on that asset is less than the cost to build, then we might see leverage in the P&L. But at 5% penetration, that's a long way out into the future from what we can see and the opportunities we have to invest. And then on the balance sheet, we wanna keep that conservatively geared in all senses. Greg will talk about inventory later. We want to carry a lot of inventory to buffer supply risks. We wanna be, and we are, cash positive and have debt facilities so that we have significant liquidity, should we need to call on it.

Clearly, we've got the buyback going on, because we've got more cash than that at the moment, to step our way down to these targets. Then, in terms of being agile and efficient, so we have said we're gonna come under our 18% net profit margin for the last couple of years and the next few years, while we spend about AUD 150 million on reworking our global processes and our global platforms. We've made good progress here. We have, in the last quarter, implemented Workday and Salesforce Health Cloud. We've done those successfully, and that there's been no operation interruptions from doing it. We've moved smoothly over the new systems. We now have consistent processes around these systems around the world, and we're starting to get and see consistent data.

Next, the next steps here are to replace our core finance system and our supply chain systems. It's not just about putting these platforms in, 'cause that's, while that's really important, and we're already now looking with, for example, with Salesforce Health Cloud, is how can we use some AI add-ons that Health Cloud provide to streamline our customer service. It's also about our operating processes and operating mechanisms around the, around the company, and how we get consistency and clarity, yeah, to those, so that we can actually move faster. We're not only gonna get more efficient, but actually be able to change faster because we have more consistency. Good progress here.

These are really important steps in terms of building an organization that's capable of supporting a much larger customer base with the level of customer experience and customer service that's now expected from our customers, who don't compare us to our competitors, but compare us to an Amazon or another, or actually, an airline is the wrong example. An online store in terms of the service that they get. And then Greg will talk to manufacturing and how we work to maintain that 75% gross margin by continually finding ways to improve processes there.

Clearly, we want to do this responsibly in terms of corporate governance, in terms of making sure as best we can, our supply chain and our suppliers adhere to modern slavery, or avoid any sort of forms of slavery. There's very clear modern slavery guidelines out there. Cybersecurity, clearly, we invest in that and in data security as well, as you would expect. So in summary, here's our sort of strategy on a page, thinking about the ways we create value, our strategic priorities, our targets for each of those priorities, and being clear on how we provide value for all of our stakeholders. So I'm gonna finish up there. So I'm gonna move pretty quickly, 'cause I want you to get on to more depth from the other executives.

Happy to take a question or two on the strategy now, but suggest it might be better to wait till the end, 'cause questions are probably gonna be answered. Good chance they could be answered by the coming presentations. Okay, no questions. So I'm going to hand over to Jan Janssen. Now, Jan is our Chief Technology Officer. He has been with Cochlear since 2000. Came to Cochlear through the acquisition of Philips Hearing Implant Business, so a very long history in cochlear implants. Jan has been responsible for our R&D since 2005, so clearly very deep knowledge of hearing implants and the technology. And here to talk about our approach to R&D, some of the things we're working on, and also be joined by Adi Nilsson and Roger Smith, who Jan will introduce part through presentation. Jan?

Jan Janssen
CTO, Cochlear Limited

Thank you, Dig, and thank you for your kind words in introducing myself. So in this session, I really would like to give you a perspective in how Cochlear is thinking about future innovation of our products and services. So I'll deliver this together, like Dig said, with Adi Nilsson, who is our VP of the Acoustics product portfolio, and Roger Smith, who is Product Manager working in our sound processor area.

I'd like to start actually with a small anecdote, if you want. So this is a letter that we received a few months ago in our Denver office from a recipient called Ophelia, who is, I think, nine years old. It says, "Dear Cochlear Corporation, I would like it if you could make a cochlear implant that is waterproof with no case." And today, you have to put the processor in a little case to make it waterproof. "I think it would be very good to have one. This is what I think it should look like." And she has a picture, and it has an LED in there. And then she explains why she wants to have it. She says, "I do not like it when I have to put on a case because other people go in the pool before me." Yeah, yeah.

And, I hope you can help." That's what she wrote us. And why we have this, why we include this letter, because I think it shows that for her, hearing again with a cochlear implant, she's taking for granted now, yeah? It's now about living her life and getting in the pool before her friends do. Yeah. So, I think it is a good illustration also for adults, where we today. Cochlear implants do provide tremendous benefit, but there's still a lot of opportunity in how we can make the product easier, more convenient for people to get on with their lives. So it's always an interesting letter to start with.

So, today, we find ourselves in a strong position with our portfolio, and I think it's fair to say that in many aspects of the product portfolio that we're offering, we are setting the benchmark. Cochlear is setting the benchmark with our cochlear implants in terms of reliability, as you saw from Dig, but also in terms of size, in terms of the electrode technology. In the acoustic implant area, you're gonna hear more about that. We created a complete novel offering with the piezo-based transcutaneous bone conduction devices. We, for a long time, have had leading products for sound processors in terms of size, in terms of connectivity, but of course, also in terms of hearing performance.

Over the last few years, we've continued to build out our portfolio of software and apps that make it more convenient for recipients to manage their hearing, for clinicians to have better tools, including the operating room. Now, I'll talk about that so that we continue to build opportunities to facilitate and simplify the aftercare through our technology, including telehealth solutions and of course, what we provide for our customer service. But there's still a lot of opportunity we believe to do better. The way we think about future innovation and the key pillars where we continue to focus our R&D investment dollars have to relate to hearing outcomes, and so I'll talk about each of those in the session today.

But then also, like the letter from Ophelia indicated, also about how can we help people with our technology to make life even easier? Use technology to really simplify and streamline the aftercare, and so we put that under the banner of Connected Care. And then we're always on the lookout in how we can continue to expand the portfolio of options that we provide. Like Dig indicated, 40 years ago, Cochlear provided, started to provide cochlear implants. In 2005, Cochlear acquired a company in Sweden to have a second product family with our bone conduction, with our Baha bone conduction devices, which are percutaneous devices.

But over the last few years, we've expanded our portfolio with the transcutaneous through the skin, or across the skin, excuse me, instead of through the skin, bone conduction solution, and Adi will elaborate more on that towards the end of the presentation. So first, in terms of hearing outcomes, now, I do appreciate that few of you are hearing professionals, so I'm gonna try to make it as easy as possible for you to understand what is it that we're actually trying to achieve with our R&D efforts in hearing outcomes. So let me start by illustrating how hearing outcomes have evolved over the years. So what you see here on the slide to your right-hand side is the outcome from three large studies.

That is, in our world, a study of 50 is a large study that we've done over the last 20 years. So 2005, 2010, and 2017. We measure hearing. One of the measures of hearing outcomes is how well people can understand words in a quiet environment. So we play a list of 20 words, and we just check how many words that people actually understand correctly. And so that's what these green bars show on the graph here, yeah. So you see that, in 2005, there is a group of people that we would call star performers, who get, like, 7 out of 10 words right, yeah? There's a larger group, however, yeah, that even with a cochlear implant, still doesn't get more than 3 out of 10 words correct.

Now, I have to mention that before people get a cochlear implant, they typically have about 1 in 10 words correct, yeah. So their hearing performance is about 5%-10% in this test. So as you see that, as time has progressed and as technology has progressed, you see that the group of people who do really well with a cochlear implant is growing. You can see now about a third of people we would call star performers with a cochlear implant. And equally important, it has the group of people that actually do not achieve the outcomes that we would seek with the device is shrinking and shrinking to about 10% or 15%.

And so that's a combination of the technology that has improved over the years, better electrodes, better sound processing technology, but also the fact that over the years, the indication has expanded. Now, when I say indication expansion, it comes in two forms. So one is that formerly, reimbursers have accepted for people to reimburse cochlear implants for people that have, let's say, more levels of hearing than we had, say, 20 years ago. So that's kind of the, if you want, the formal expansion of indication for aftercare. The second one is actually, what is clinical practice, yeah? So if you look, 25 years ago, people that would receive a cochlear implant, for example, in, in Melbourne and Australia, would have about 115 decibels of hearing loss.

If we look today, that has dropped down to about 90 decibels of hearing loss. Our indications actually go down as low as 70 or 60 dB of hearing loss, yeah. So we still have a lot of opportunity, for more people to be, to be treated. And often there's a lag between what is reimbursed, if you want, and what's formally allowed, if you want, through the regulatory reimbursement system and then clinical practice. But it's those two combinations, the fact that people get implanted earlier, yeah, is also a driver of better hearing outcomes. We saw that with children. If children of, are born with severe, or profound hearing loss, if they get implanted, say, before the age of 12 months old, they will have near normal development, typically. The same is true for adults.

The earlier that adults are implanted, the more likely is it that they will get better hearing outcomes with a cochlear implant. So we have great progress, yeah, in terms of how people hear, yeah. But still opportunity, because ultimately, of course, we'd like people to have 100% hearing in a quiet environment, at least. But of course, we live in a noisy world, and when we talk about hearing outcomes, we talk about also, excuse me, about things like hearing in noise, telephone use. Typically, one of the things that people struggle with big time before they have a cochlear implant is using the telephone, and Roger will probably talk to that, but also about binaural hearing, hearing in two ears.

And so if you look at the, if you want, the block diagram or the schematic of a cochlear implant, which picks up the sound through microphones, it then passes through a stage where we do what we call pre-processing. That is where we try to remove as much noise from the microphone signal as possible from other speakers or fans or things like that, before then goes into a step where we analyze the sound, break it down, in our case, into 22 frequency bands, that are then delivered through the electrode to the auditory nerve. And then in the block diagram, there's the user, who has a level of control over the device, as well as the clinician, who will, during the fitting, set the number of parameters.

So if we look at where we have made most progress over the last 20 years in terms of hearing and noise, it has to do with these front-end steps here. We've went from a single microphone to dual microphone, and that we can then connect with technology that would be similar to what you use, basically, when you're on an airplane, noise-canceling headsets, yeah. It's similar type of approach, where with using two microphones, we can do smart processing and really improve that hearing and noise, and I'm sure Roger will also talk to that. And importantly, over the years, we've also automated that type of sound processing, because we know that it can be difficult for people to know when should I switch on this algorithm versus that algorithm.

So we have a type of artificial intelligence actually built-in already into the product that does that, based on the auditory scene. It's called an auditory scene classifier to make that change. So these are the areas where we've made a lot of progress in terms of hearing and noise. Still a lot of opportunity left there to do better. However, and then, of course, a big step forward since 2017 for cochlear implants, when we could achieve connectivity, direct connectivity between a smartphone and a cochlear implant sound processor, because that opened a complete new world for our recipients to connect through their phone for phone calls, for video conferences, watch movies, et cetera. But if we also think about other aspects of hearing outcomes, and then I talk about things like listening effort.

A lot of people that with hearing loss will often say at the end of the day, they're completely exhausted because the brain has to work a lot harder to listen, to hear. Music appreciation, sound identification, speaker identification, so that's the ability to tell two speakers from each other, something that we can do very easily, yeah? People with a cochlear implant, for people with a cochlear implant, it's a hard task. If we also want to drive further enhancements in those areas, then we need to turn our attention also to the what I would call the back end of a cochlear implant system. That is, how do we process the sound? How do we deliver it to the hearing nerve, and how is it programmed in the clinic?

And I'll elaborate a bit what our philosophy is, for in that, in that respect. So our philosophy to improve, if you want, the back end of the, of the cochlear implant system, is first of all, to deliver the electrical stimulation as close to the nerve as possible, yeah? And I'll explain what I, what we mean by that. So that's again, the first part of our strategy to drive hearing outcomes, to the blue part of that, of the graph. Secondly, it's important also that while the electrodes arrays inserted into the cochlear, the cochlear is a very delicate organ. It's the inner ear. It's a Greek word for inner ear. Is that that's done in a as atraumatic way as possible, because we know there's more trauma that actually will negatively correlate with future hearing outcomes.

The third pillar of our strategy there is to improve the quality of the stimulation of the nerve by being more precise, and I'll explain that as well. Then the last very exciting pillar that's really gaining traction over the last few years is the combination of drugs, of pharmacological solutions together with a cochlear implant, and I'll elaborate on each of those. So first of all, in terms of the electrode technology, so what you see on the graph there, here's a schematic picture, if you want, of a cochlea, and you can see that there's kind of two ways, or two places where the electrode could be placed.

It could be placed to the outside of the cochlea, that's called the lateral wall, or it could be placed closer to the inner side, to the inner wall, if you want, of the cochlea. Why is that important? That's important because the neural elements, so the hearing nerve that we are stimulating is present in the center of the cochlea. So by putting the electrodes closer to the cochlea, yeah, we can reduce the stimulation currents. Yeah, means better battery life, for example, but also, and I'll explain that a bit, in more detail, in later slides, that also helps us to minimize crosstalk, if you want, between the 22 channels that can be present.

So there's a lot of very strong rationale on why it is, makes a lot of sense to deliver the stimulation as close to the hearing nerve as possible. Now, Cochlear offers both types of electrodes. Often there can be physician choice, preference for one versus the other, but we do believe strongly that in the longer term, perimodiolar electrodes will be an important stepping stone to optimize hearing outcomes for recipients. So as I mentioned, it is important, or we've shown through research that it is important, that we can minimize trauma during insertion. Now, we do that in many different ways that we try to achieve that. The most important one, in fact, by having an atraumatic electrode, yeah.

So our electrodes that we've developed, that we have currently in the market, are a lot thinner and more flexible than the devices we had, say, 20, 30 years ago, and have been designed really with being atraumatic, yeah, in mind. But we also know that surgery, while routinely, can still play an important role in the insertion process. So we are in the process to introduce a new tool in the operating room called Nucleus SmartNav. It's already rolled out in the United States. We're rolling it out in other parts of the world as we speak. That's iPad-based. So it's an iPad. It has in a small, what we call a surgical processor, which takes care of the communication from the iPad to the processor and from the processor to the implant.

SmartNav delivers in a wireless fashion real-time actionable insights that help and provide assurance to the physician, yeah, during and after the insertion process. So it will provide a range of diagnostic measures to confirm that the device is working properly, that the nerve is responding, because that's definitely a peace of mind for the surgeon to know, "When I stimulate while the patient is still in the OR, the nerve is actually responding." So cochlear implants can not only stimulate the nerve, we can also measure back from the nerve. And also SmartNav, we've taken the opportunity to also facilitate and streamline some logistical steps, if you want.

In fact, on the bottom right here, you can see that with SmartNav, we now can automate the implant registration, something that used to be paper-based in the past, and often there was a long lag between the surgery, where people had to fill out then all the details, send it through a paper document to us. That's also one of the features we've integrated into SmartNav, together with a range of other measures, diagnostic measures that we provide. I won't go into detail. Happy to talk about those if you'd have any specific questions of that.

But I can tell you that the tool has been extremely well received, and it is for us, really also a springboard to continue to develop more and more novel measures that we can add to SmartNav, given it's a software-based solution for future use. So I mentioned about having an electrode close to the nerve, having an atraumatic insertion, but also about how can we further build on that precise stimulation. And so this is an illustration, if you want, if the electrode is further away from the nerve, so you can see here, that's the electrode. Imagine that we have now rolled off the cochlea, so as a linear representation.

So if we have, you have what we call a lateral wall electrodes, then the electrodes, the electrical current that occurs during the stimulation, yeah, will actually spread out quite broadly in the cochlea. The cochlea is a very conductive medium. It's a bit like seawater, yeah. So the ions kind of will kind of wave around quite broadly, which means that there's a fair amount of, if you want, distortion or a crosstalk across the 22 channels. Ideally, we'd like each of these 22 electrodes to target just one twenty-second of the, of the hearing nerve, yeah. But because that high conductive medium, that's not the case. Nevertheless, with lateral wall electrodes, people can hear well, yeah. It can get... Still, people can get good outcomes.

But if you want to enhance that, then, of course, it makes a lot of sense to bring the electrode closer to the nerve. And that's really what we have done with our perimodiolar electrodes. We started pioneering in this already in the 1990s, had our first product on the market in the early 2000s, and it is absolutely differentiated for Cochlear to have a perimodiolar electrode. One of our competitors also has something that's what perimodiolar, the other competitors actually don't have, has not been able to deliver a similar technology. So as we bring the electrodes closer, that allows us to reduce the stimulation current because we're now closer to the neurons that we target, yeah. And that helps us, yeah, to a certain extent, to limit that crosstalk, if you want, between the 22 channels.

But we don't want to stop there. And so we are working now, in still in a research fashion, to other ways that could further focus that stimulation. And so, we're looking at electronic means in combination with the perimodiolar electrode to further deliver that stimulation more precisely and with less overlap, if you want, between the 22 channels. And what we've seen from early research is that that should contribute to improvements in the, on the blue aspects of hearing outcome, sound quality, music perception, hearing in noise potentially, et cetera. So you can see where we're trying to go with this. And then you can think also further in the future, if this is indeed an effective way to be more precise in the stimulation.

Perhaps one day, we can also then increase the number of channels, yeah, from 22 to 32 or 64, whatever that might be in the future. But the first step is to make sure that the 22 can actually work more independently from each other. Yeah. So, again, this is still in clinical research, and often these things, of course, take many years in our world to try these things out. Also, because when we try out these ways of stimulation, the brain often needs time to adjust to the new way of stimulation. So the brain has to learn how to hear with electrical stimulation, and when you make a change in how we stimulate, the brain doesn't respond immediately.

It needs time to adjust often, and then readjust to that, and only then we'll know whether one way is better than the other way. So that's one of the reasons also why it can take a while for us. And then the last aspect of our strategy to continue to drive hearing outcomes is the drug- device combination, yeah. So we already shown in a feasibility study a number of years ago, that embedding a steroid, yeah, into the cochlea, into the electrodes, so that's the part that goes into the inner ear, can help actually to reduce the electrode impedance, as you can see that to the right here. So the feasibility you see here in the black dots is a standard electrode.

The open dots were the patients, or the impedance of the patients that received this drug-eluting electrode. And basically, what the drug is doing, it's helping the body to deal with the foreign body reaction. As soon as you put something in the body, the body's gonna want to fight it, and by bringing a steroid into the cochlea, the steroid will be there for a number of weeks before it's completely, if you want, before it's eluted out to a level sub-therapeutic level. That really helps, yeah, over a long time. You can see it for up to two years, yeah, where we really see a lowering of impedances, which we believe has to do with the fact that there's less fibrotic tissue that's developed in the cochlea.

So we are progressing our dexamethasone research, and now towards more commercial solution in a number of years. That does take time, because to develop these devices, to make them manufacturable, to adjust our quality system, to get through the pivotal studies and then to the regulation, does take time. Also, because in medical devices, the combination between a drug and a device is not all that common. Yeah, so also from a regulatory pathway perspective, we actually have to, if you want to break new ground often and get regulators on board with this type of device. But we don't stop there, yeah. So we already continue also to look what can happen even after our drug-eluting electrode, a dexamethasone-eluting electrode.

We are in a collaboration with a French company called Sensorion for a different type of drug, an anti-apoptotic drug, that can be taken orally, or that at the moment in a small study, is taken orally. May also have the potential to be integrated in a device in the future. You may think as having even almost like a cocktail of, of drug-eluting, electrodes. And then at the bottom here, this is really futuristic. We are supporting a study that's actually running here in Sydney, where prior, just prior to the, insertion of the cochlear implant, a, neurotrophic factor, a growth factor, is actually injected into the cochlea with the idea to actually resprout part of the hearing nerve, yeah. Earlier, I explained to you that what we try to do with the perimodiolar electrode, we bring the nerve.

Sorry, we bring the electrode close to the nerve. What we try to do in this study, we bring the nerve to the electrode, yeah. That's based on preclinical research that we support a number of years ago. The clinical research is still running. It's too early to talk about this. This will be a long term, because it's kind of a gene therapy. It will take a long term before this will become mainstream, we believe, because of the different hurdles that we'll have to go through. But it's an exciting prospect in how we can use drug device combinations in the future to improve our outcomes. In terms of lifestyle and ease of use, yeah. So we heard from Ophelia. She's not complaining about her hearing.

She's complaining about the fact she cannot, she has to put on an accessory before she can jump in the pool, yeah. And so, that, I think, is a good, metaphor, if you want, yeah, for us to continue to think about how do we support our recipients with their device, yeah, day to day, yeah. Because we take it for granted, some of us will use EarP ods or earbuds for a few hours a day. But with a cochlear implant today, if you don't wear your external processor, you basically are deaf, typically, yeah, and won't be able to communicate, at all. So we made a decision a number of years ago that as a first step, we want to provide choice for our recipients. We have the choice between what is called a behind-the-ear processor.

That's a device that rests, if you want, on the pinna, on the ear. Our Nucleus 8 processor is our latest generation of behind-the-ear processor. Since a number of years, we also provide what's called an off-the-ear processor. With the off-the-ear processor, both the transmit coil that you see here lying flat, and the processing unit are both integrated in a single piece, so it's more convenient, yeah. A number of recipients really prefer that way to to hear. We won't stop there, so we will continue to search for even better ways that we can provide the external, the external part of a cochlear implant to our customers. We are continuing to look to ways to shrink the processor because we know size matters.

Not only because of cosmetic factors, but also because of retention, particularly for children. The smaller the processor is, the easier it will actually stay on the ear, for children, but also for people to live their life, making it smaller is better. And of course, we also continue to work towards the option to have an implant that could be even used without an external processor, and I'll talk more about that, in a moment. But I think this is a good opportunity for me to introduce you to Roger Smith. Roger is a product manager at Cochlear and will talk to you a bit more in depth about our portfolio of our hearing, of our sound processors. Over to you, Roger.

Roger Smith
Senior Product Manager, Cochlear Limited

Thanks, Jan. Good morning, everyone. So I think it's really clear to see there's some exciting new future innovations coming from Cochlear, but I think today it's also important to talk about the products we have available right now for our patients and for people with severe to profound hearing loss. And so, as Jan mentioned, our premium sound processors come in two different form factors, the Nucleus 8 and the Kanso 2 sound processor, and they both deliver the proven hearing and performance benefits that comes with our products, using dual microphones and SmartSound iQ with SCAN 2 and ForwardFocus technology to enable people to hear their best in any situation.

We also have a bimodal partnership with ReSound hearing aids to enable people who have a cochlear implant on one side and a hearing aid on the other side, to be able to hear well and stream from compatible devices, and really elevate their hearing experience to the next level. Both our sound processors deliver direct connectivity with Apple and Android devices. And connectivity allows also the use of a Nucleus Smart App to give them control and fine-tuning of the product, to help them really manage their life and their hearing experience. And from a lifestyle perspective, we offer a range of wireless accessories like the TV Streamer and the Wireless Mini Microphone, to help people hear better in different situations and enjoy their life there.

With lifestyle, our two processors are IP68 rated, which is the highest level of water protection available in a sound processor on the market. We also offer a range of retention accessories to make sure that people who wear our products don't have to worry about the safety and security of their products while they're living their life. An exciting new development in our sound processors is that in the U.S., we've introduced the Nucleus Smart App bimodal functionality. And so that means that patients who have a compatible cochlear implant and a compatible hearing aid on the other side can now control both devices from the Nucleus Smart App from one location on their mobile device.

And that really just goes, you know, a step further in simplifying their lives and enabling patients and users to be able to manage their situation and enjoy their life in an easier way. So that's really exciting. So maintaining that streaming capability and now introducing that bimodal control. And a unique feature that's with the Nucleus 8 sound processor, and really exciting, is the only sound processor on the market today that's ready for the next generation of Bluetooth audio streaming technology called Bluetooth LE Audio. And Bluetooth LE Audio is really going to be the next generation that's expected to replace the current Bluetooth Classic audio streaming. And it's going to open up the doors for both manufacturers and users of audio devices, because it...

This new technology uses lower power, and efficiencies, and also better quality, of sound delivered. But what's really, sorry, the LE Audio protocol is going to take some time to be adopted around the globe. And while that's happening, there's a lot of excitement building now for this particular, profile within LE Audio called Auracast. And Auracast is about the ability to broadcast stream, any sort of audio experience. So if you've got, like, today, and I'm speaking with a microphone, they would be able to send the signal acoustically, but also broadcast, my voice digitally. And so there's different—it's going to open up the doors and, and lots of different, activities that'll be possible.

So imagine two kids who are watching a video and, you know, sharing an iPad and watching a movie or something. And one of them might have off-the-shelf wireless headphones, and the other one might have Nucleus 8 sound processors. They would be able to sit and share that movie and watch together. It's something they can't do today, so that's exciting. Another activity is actually, if you imagine at the gymnasium, you know, when you're working out, or at the doctor or a reception area where they always have the TVs, but they're muted to keep things quiet, you could select that TV and the one that you wanted to watch, catch up on news or whatever, and stream that directly to your ears. So it's a very exciting capability there as well.

But I think what really resonates most with our patients and customers is this ability to hear you best. So streaming in situations, locations, so think about lecture halls and presentations like today, at the airport or the cinema or theater, anywhere where there's an audio experience, that location would be able to send out the audio experience acoustically, but also broadcast the signal digitally, and anyone in the audience could be able to pick up that signal. A classic example that I think really resonates is at the airport, where some people are very nervous about flying because they're afraid they're going to miss an announcement at a gate. The gate's changed or it's delayed.

Now, that person will be able to sit in the airport and select gate 17 Qantas, and anytime there's an announcement made, it would stream directly to their devices, hearing aid, sound processor, or even headphones, and they would be able to hear that announcement as if it was spoken right next to them. So really exciting technology there. And the Nucleus 8 is the only sound processor available today that's ready for next generation LE Audio. So I think that's very exciting to point out. I wanna change gears slightly now and tell you a story about a recipient, a cochlear implant recipient, because I think it's important for you to all understand just what these products are doing for people and improving their lives and how much of a change it is.

And that person I wanna tell you about today is actually me. So I don't know, most of you probably can't see, but I'm a bilateral cochlear implant recipient, and I have two Nucleus 8 sound processors on today. I was first implanted in the United States in 2009 on my left side, and then I moved to Australia and began working for Cochlear, and I got my second implant in 2021, became bilateral. So I was bimodal for a time, and now bilateral. And it, it's been a life-changing experience for me. I was born in the U.S., in Iowa, and I had mild hearing loss at age five, and that continued to progress, and my hearing got worse, and I was given hearing aids as a teenager.

You can imagine that didn't go over very well. Didn't wear those too often, but by the time I was in university, I was really struggling to hear, and I knew that I needed to use hearing aids if I was going to get a university degree and get a career in my life. And I got, you know, really good hearing aids, and they helped me, but I still needed to have note-taking service and study buddies and a few things like that to help me really get through the experience. I did graduate, and I moved on, and I started my career as a physiotherapist. And, you know, I think like many people with chronic hearing loss over time, their world, my world adapted with me.

So my friends and my family, my job sort of adapted with me, and I got more powerful phones, and they spoke louder. So I was doing okay. I knew I was missing out, but my friends would cover for me and help out. But I got the sense that there was just... I was missing something. And then I had children. And when I had kids, it was so hard for me to hear what they were saying as they began to talk, and I just started to feel more and more like I was really not living my life to the fullest. And so that's when I met someone with a cochlear implant.

And I think the experience that we hear very often here is that someone had the catalyst, something that gets them to take a step and move in the direction of getting a cochlear implant, whether it's to accept that they have hearing loss and they have a problem and they need to do something about it, to realize that their hearing aids are not helpful enough or to maybe think a cochlear implant really is something that I would, I could use and would benefit me. It's fun for me to tell this story because my catalyst was actually my older brother.

And so my brother is four years older than me, and he had the same trajectory of hearing loss and progressed very much the same way as I did, but he was always kind of taking the first step, getting new hearing aids and telling me about the experience and, you know, doing, using assistive devices or whatever it may be. And then one day, I got a call that he was going to get a cochlear implant, and I was really surprised by this, but secretly very happy because I knew now he was gonna, you know, this person that I knew and trusted was going to be able to tell me what it was really like and would it be something that I would want to do. And so, three months after he got his implant, I went over to...

He was having a birthday party for his kids, and I went to his house, and I was excited to ask him all these questions about, you know, "What's it like? How are you doing? Can you hear better?" I didn't even have to speak to him. I walked into the party, and I could see him across the room, and he was a changed man. It was, it was so incredible to see, you know, the confidence that he carried himself with and the, the happiness that he exuded and, and, you know, his interaction with people. And it was just, I didn't need to talk to him, but I did. And we were chatting, and he was, his girls called to him, and he's talking to his little 3-year-old across the backyard, and I could barely hear their voices, and he was having a conversation.

It was so incredible to see that transformation. So, you know, I said, "How do I get one of these?" And of course, six months later, I had my own cochlear implant, and happy to say, the experience was as life-changing for me as it was for my brother. So I like to tell that story because I think it's so important for you all to realize, you know, just how life-changing and how amazing these products are and what it can do for people with severe to profound hearing loss. So, I thank you for listening. I'm happy to share my story. And now I think I'm gonna hand back to Jan, who's gonna talk a little bit more about how we're working to improve our products to help people live their lives. Thanks.

Jan Janssen
CTO, Cochlear Limited

Thank you, Roger, and it's always fantastic to hear from firsthand what the impact is that the technology makes. So, as I alluded to, we have two options for the external sound processor, but we also keep looking for a way that people could use their implant in a, what we call, totally implantable fashion. So, that means that device needs not only to have the traditional functionality of the electrode and the electronics to stimulate, it also needs a microphone, it needs an implantable battery, and it needs a sound processing capability all built into the implant.

So that's quite a challenge, and to tackle that, we had our first attempt with a first-generation research device all the way back in 2005, 2006, when three patients were implanted with the very first generation of totally implantable device. So a few things we learned from that. One is people really appreciate the fact that they can hear even without a sound processor, because I have to explain that these three patients can use a device either with or without a sound processor. If they put on the sound processor, it works like a traditional cochlear implant. If they take it off, it works via the implanted microphone. So they can kind of have both options.

So people really appreciate that they have the option to hear without an external device, but at the same time, they told us that the presence of body noise, eating, swallowing, chewing, things like that, was extremely loud. And that really gave us pause to think, okay, we do need to come up with technologies that make that, if you want, more acceptable, particularly if we think about a commercial device. So we went away and looked at solutions that we can tackle that, but our big takeaway was is how valuable this invisible hearing aspect is. So it, at the same time, gives a lot of motivation. So we started then to work on a second generation. So here you see a picture of the second-generation, totally implantable research device.

You recognize that the microphone is now separate from the implant, and this microphone actually does have the capability to suppress or eliminate part of the biological body noise. And so, again, like in the first generation, recipients can use it with an external system, and they also have a charger that they can use to charge the implanted battery. And here you can see the two wearing modes. So either people wear it with an external processor, will look similar, like Roger will look today, or without, and they still have the option to be able to communicate and to hear. So 10 patients were implanted with this research device a few years ago.

Important to point out that preoperatively, so before getting the device, these patients had about a 3% sentence understanding. So this is just an indication how poor people hear, typically, before they receive a cochlear implant. And then after 6 months of receiving their device, they actually score now around 80%, even with the invisible hearing mode. So you'd see a fantastic improvement between pre-op and post-op. Still a little bit of difference. So the gray bars or the gray box here is what people hear when they wear the external processor versus the invisible hearing in yellow. And we expect that there will be a bit of a difference there. But the main comparison, of course, is with what we heard before they had a cochlear implant, yeah, which was all the way here. Yeah.

So of course, this gives us a lot of encouragement to continue this development. Like I pointed out, it's still a research device, still a lot of compromises that we had to accept for this device. But of course, with this positive feedback, we are very motivated to deliver this type of technology to our recipients into the future. So let me now introduce you to Adi Nilsson, who will talk about the last pillar of our innovation strategy. Oh, sorry, sorry, sorry. I'm ahead of myself. Connected care. Too many slides. Excuse me. Yeah. So the third pillar of our offering relates to Connected Care.

So this is how, through the journey, from what happens in surgery, what happens in the hospital, what can we do remotely, and what can we do by providing control in the hands of our patients, in simplifying and supporting patients at every stage of their journey. And our goal really, with our Connected Care portfolio, is to provide this convenience and confidence to all of our customers. What I mean, all our customers, it's to the recipients, it's to the surgeons, the physicians, as well as to the audiologists. And so we do that by the real-time surgical guidance that we are now providing with our new SmartNav solution, by more convenient care delivery options that we have. So the follow-up can ...

Care can happen either in person in the clinic, but since a few years, we also have options for the professional to deliver care remotely from the comfort of the recipient's home. And importantly, is that through this, of course, we also get a lot of insights that help us also to improve our products going forward. So it's about convenience and confidence, but also about clinic efficiency. We know as we continue to see the continued growth of cochlear implants, that that is putting pressure on the aftercare in hospitals. And Dig and Lisa also may talk about that. And so it is important that we do make that aftercare also more efficient, and of course, evidence driven.

Then, the data that will be collected as we provide these more modern ways of providing that care will support us by generating better evidence, also from payer perspective. And it will also allow us to, likely in the future, optimize the stimulation and the processing more to the individual. So form of more personalized care that we can provide in the future. And now it's time to hand over to Adi Nilsson to talk about the expanding portfolio. Sorry about that.

Adi Nilson
VP of Acoustics Portfolio Product Commercialisation, Cochlear Limited

No worry.

Jan Janssen
CTO, Cochlear Limited

Thanks, Adi.

Adi Nilson
VP of Acoustics Portfolio Product Commercialisation, Cochlear Limited

Thank you so much, Jan, and hi, everybody. Great to be here today. My name is Adi Nilsson, and I'm based in Sweden. Been with Cochlear for more than 12 years, working mainly with the acoustics portfolio. So my job today is to briefly tell you a little bit about the Osia System, which is the latest innovation we introduced in this portfolio. So the Osia System was developed to remove boundaries to bone conduction. Bone conduction implants been in the market almost as long as cochlear implants, but for various reasons, haven't been as appealing to both patients and professionals. So Cochlear have began the development of the Osia a few years ago, and we've been introducing it to the market 4 years ago.

And it's powered by unique Piezo Power technology, which enables improvement in hearing in the high frequencies. And why do you want improvement in the high frequencies? Because that's where everything good happens, as one of our surgeons said. It's the voices of babies, children, the birds, it's whispers and all those kind of things. So, very important improvement for bone conduction patients. It's also discreet and easy to use. Since we introduced, we actually have implanted it in 14,000 patients. I know Dig said 12, but I actually watched the numbers, and it is 14,000. Very proud about that. It actually makes it the most preferred bone conduction implant system in the world. And also, we usually say, it's the fastest growing hearing implants ever introduced.

So very proud about that. And of course, it's also thanks to the fact that it's discreet and easy to use. So, in the spirit of always bringing meaningful innovation to the market, we recently also introduced it with a 3T-compatible magnet. So that's the OSI300 implant that we've introduced in the U.S. We got an FDA approval or FDA clearance at the end of August and introduced it in the beginning of September. And that makes Osia the only bone conduction active implant in the market that enable 3T MRI scanning. And I think we all know, I don't need to talk to you people who already know that we have it with our CI technology.

But we all know that 3T scanners are becoming now the standard of care for MRI technology, and great additional improvement also for bone conduction patients now. So, how does that technology really work? So already mentioned some benefits with the Piezo Power transducer, but it's also very suitable for implantable solution because that it has no magnetic material in it. It mean there is no material that attract to the strong power magnetic field in the MRI scanners. And that's why it make it more suitable, unlike other. So if we talk about the competition, they have today an electromagnetic transducer that is implanted, and that doesn't make it as suitable for MRI scanning in the same way. Definitely not up to 3T scanners that are now, as we mentioned, already standard in the market.

And the new addition to that technology is the new magnet that we have now introducing with the 3T magnet, and I'll show you a little bit about how it works. But basically, it's align itself to the direction of the scanner, so where the magnetic field of the scanner is working, and lock itself there and stay in place, so there's no risk for dislodgement or any other things that can happen during the MRI scanning. So back to what are the benefits for the patients, and in what way the Piezo Power is really beneficial. So it's mean that we don't need to remove the implant, which sometimes is needed, so no need for unnecessary surgeries.

There is a minimal image artifact, because many of our patients sometimes need to undergo MRI again if they have, you know, diseases in that area. So with the Piezo, there's no need for that. And like I said, because there's no risk for using and moving parts, so there's no performance degradation, and it will withstand the exposure of the strong magnet field. This is just an illustration of how that magnet works. Once it gets into the MRI machine, it locks itself, aligns itself to the direction of the MRI field and stays in place. An additional feature that I would like to mention is just the, as you can see, there is simple magnet removal, if needed, depending on the patient's condition. There is still a possibility to do that.

That conclude my presentation on the Osia, and I will hand over to you, Jan, to conclude that session.

Jan Janssen
CTO, Cochlear Limited

Yes, so I hope that I've been able to give you a good overview of Cochlear's philosophy and strategy in terms of future product innovation. So we continue to invest around 12% of sales revenue in research and development. Now, that does include also clinical studies, regulatory clearances, and things like that. Which I hope that you could see that the strong pipeline of products and services that we continue to work on to continue to drive hearing outcomes. It's cochlear implants do provide a life-changing intervention to many patients, but there's still a lot of opportunities to do even better there. And then particularly, to make life easier living with a cochlear implant through what we do with our processors and our totally implantable devices.

Simplifying that aftercare to make it convenient, efficient, both for customers, end users, as well as for clinicians. We continue to look also for further ways we can expand our portfolio. I think Adi shared with you what Osia has done for Cochlear in terms of creating a new fast-growing segment, and we continue to look for other opportunities, too early to talk about today, to broaden our portfolio of offerings. So I think that we pretty much used all the time, but maybe still some time for questions. Yeah. If any questions you might have.

Craig Wong-Pan
Director, Senior Equity Analyst, RBC Capital Markets

Hi. Hi.

Jan Janssen
CTO, Cochlear Limited

Yes, I can hear you now. Yeah.

Craig Wong-Pan
Director, Senior Equity Analyst, RBC Capital Markets

Hi, Craig Wong-Pan from RBC. Just a question on your TICI. So you kinda mentioned there's a bit of still sound, sort of body noise there, and I think you mentioned that, or on the slide it says, finalization of product development. Does that mean there's gonna be another generation before you have that commercialized?

Jan Janssen
CTO, Cochlear Limited

Yeah. What we showed here was a second-generation research device.

Craig Wong-Pan
Director, Senior Equity Analyst, RBC Capital Markets

Yeah.

Jan Janssen
CTO, Cochlear Limited

What we often try to do with our research device is to make sure we understand the key aspects and the key challenges that we need to overcome, and that was the purpose of this device. So the device, as you see it here, we indeed think it's not suitable yet for commercial introduction. So we do want to refine a number of aspects, as we often do after these studies. And similar to what I mentioned about the drug-eluting electrodes, given the novelty of this technology, we'll have to also indicate significant clinical studies.

And also the regulatory approval pathway for a novel device like this, we expect to be quite significant, compared to what we usually do as a mere, if you want, generation improvement of a product. But like I said, we're very encouraged by the results there, including the recipient's feedback about the body noise cancellation. It's clearly working, yeah, and clearly doing a good job in making the sound quality acceptable for the recipients in the study.

Craig Wong-Pan
Director, Senior Equity Analyst, RBC Capital Markets

Thanks. And, one of your competitors has another TICI that kinda uses the ear as like a sort of microphone. Could you make any comments about what you think about that? Is, you know, I mean, how does that compare to yours?

Jan Janssen
CTO, Cochlear Limited

Yes. So when we think about a totally implantable device, you need to find a way to pick up the sound. There's a few different ways that that can be done. The solution that we are going for with this generation is called a subcutaneous microphone. So it's a microphone beneath the skin. Another type would be a middle ear microphone, a microphone that picks up the sound in the middle ear, so where the ossicles move... and there's even the option to put up the sound, pick up the sound in the cochlea. It's called an inner ear microphone, yeah. And so we deemed that at this stage, the trade-offs are most favorable towards a subcutaneous microphone. It's surgically definitely simpler than any of the other types that are there.

Potentially serves also broad age category, yeah. Now, whether we get regulatory clearance for broad age category, that, that's yet to be seen. And we do see actually very good performance with it. But typically, to Cochlear, we always keep working, yeah, and we don't typically put all our eggs in one basket, yeah. So we also continue to build portfolio of technologies that will give us other microphone options in the future as well.

Andrew Goodsall
Senior Healthcare Analyst, MST Marquee

Sorry, it's Andrew Goodsall from MST Marquee. Just interested in any advances you're making with robotic surgery. I know that's quite an issue, and some of your competitors are making some advances there.

Jan Janssen
CTO, Cochlear Limited

Yeah. Yeah. So, when you talk about robotic surgery, there's two aspects that come to mind. So one is the placement of the implant, yeah, and the access to the cochlea. That's one part, if you want a potential area for robotic surgery. The other one is the insertion of the electrode into the cochlea, which is this kind of delicate step where you kind of typically, manually, the physician will insert the electrode. To date, I would say most of the research has been focused on the second aspect. There's been some work on the first aspect, which is getting access to the cochlea, which is actually quite deep into the head. It's about the same depth as your eye, so it's a few centimeters deep. That aspect, I'll leave that aside at the moment.

So the focus today is really on that robotic insertion of the electrode array, where the hypothesis that if you could do that in a very controlled, potentially slow and very smooth way, that that might contribute to the preservation of any residual hearing. So none of our competitors are not, like, directly active in that themselves, but typically work with other parties to do that, and so are we. So we are collaborating with a few of these robotic insertion companies to look for options, to see if indeed this the combination of a robot with a device is worth it.

Because it does add time, cost to the procedure, and as we want to streamline this, given the huge growth, of course, we always need to think, is this improvement actually going to... Is this addition to the procedure actually gonna deliver a better outcome? But we are actively working there with the companies in this field.

David Stanton
Head of Healthcare Equity Research of Australia, Jefferies

Dave Stanton from Jefferies. You've been talking to clinic efficiency, improving clinic efficiency for some time. I mean, I wonder if you could talk to, you know, what you've seen in terms of some metrics, in terms of that improvement over, over the journey, and where do you think it'll get to going forward, in terms of basically seeing more, more patients in a clinic, please?

Jan Janssen
CTO, Cochlear Limited

Yeah.

Dig Howitt
CEO & President, Cochlear Limited

Wait, wait. Hold that one till Lisa's presentation, 'cause she's gonna talk to that one.

David Stanton
Head of Healthcare Equity Research of Australia, Jefferies

Can I just ask you a question about signal processing? I mean, how much bang for the buck can you get out of that, just in terms of ongoing miniaturization, you know, better algorithms, that kind of thing? I mean, you've talked quite a bit about the miniaturization of the mechanical components, getting nerves closer to a device, that sort of stuff. But what about, you know, post-processing of information? Is there anything more to be gained from that, do you think?

Jan Janssen
CTO, Cochlear Limited

Yes. Perhaps I'll answer my dramatic question, your question in two pieces. So there's what we call the pre-processing stage, yeah, where we use with, where we've so far done most improvements based on the dual microphone technology and using the, if you want, spatial selectivity to focus the speech on the direction where it's coming from, and then suppressing any noise comes, that comes from other directions, and that's proven to be very efficient. You might have heard in the video at the beginning, someone talked about this algorithm called ForwardFocus, which can basically suppress the background noise by about 6 dB, which means it's half as loud as it would be, would be otherwise.

There's still a lot of, if you want, fuel in the tank in that space, we believe, particularly as we think about AI, deep neural networks. There's still a lot of opportunity there. One of the challenges in our world is always, can we deliver that for an acceptable power budget? Because we want to keep the processors small, and so a lot of investment actually is in the microchip technology that gives that processing capability at an affordable, if you want, power consumption. But the second part is then the back end stimulation, and that's really the combination of the electrode technology, yeah, with the stimulation processing.

Yeah, and so when I showed the graph there, or the picture with the blue bars that further focus the stimulation, yeah, that, in combination with different sound processing algorithms, we believe has the potential to further improve hearing outcomes, when we think about sound quality, music appreciation, things like that. But also things like speaker segregation, yeah, is to be able to tell two different speakers apart, which is a really difficult task for a CI patient today. But it goes hand in hand with the technology and the stimulation strategy, yeah. But we have quite a significant research program on that, still running as well. Yeah.

Dig Howitt
CEO & President, Cochlear Limited

I might too. There's lots of questions for Jan, but come back to this at the end, if that's all right, and then, 'cause Jan will still be here. But so we can keep going with the presentations, 'cause some of these questions may get answered on the way through. Thanks. Thanks, Jan. So after Dean, who's going to present now, we're gonna have a short break. But do want to introduce Dean Phizacklea. So Dean is our Senior Vice President of Global Strategic Marketing, been with Cochlear for seven years, been over seven years now, in this role.

Prior to Cochlear, a long history in medical devices and pharmaceuticals, working in Europe, in Japan, in the U.S., in both, P&L roles, country management roles, as well as in, global marketing, head of global marketing roles. So very broad experience. Dean's gonna talk about the pathway and standard of care, and one of the great things Dean brings to us is experience of bringing standard of care about in other therapeutic areas.

Dean Phizacklea
SVP of Global Strategic Marketing, Cochlear Limited

Thanks very much, Dig, and morning, all. I think Jan's done an eloquent job in describing the wonderful product portfolio and the change that brings to patients, and Adi's done the same from an acoustics perspective, and then the very personal story that Roger shares of what this does to individuals. And I guess my presentation is a way of how do we join those two together? How do we bring this wonderful technology that we know changes people's lives to those people who'd most deserve? And certainly, we've got some success in pediatrics. The bigger challenge we have is in adults. And so as I go through the presentation today, sort of three big chunks in that presentation. One is around, well, why is this important?

Why do we think there needs to be a standard of care or a more efficient, effective referral pathway? A second part of the presentation will cover elements of what are those big barriers that are preventing that pathway to be established. Then the third piece is give some high-level views of some of the activities, strategies that we have in place to help close that gap and build that referral pathway. And I'll keep it relatively high level because I think Lisa as well, in her presentation, is gonna give some real-life, deep dive of what that looks like at the country level. So why do we think it's important to have a referral process for adults? I think Dig touched on the significant global health burden that hearing loss is.

So the latest World Health Report, the World Hearing Report coming out from the WHO, excuse me, talks about 20% of people across the globe have some form of hearing loss. That's even more acutely felt, in that age group of adults and seniors, where, one in three have hearing loss, and almost all of those over the age of 60 would have a form of, severe to profound hearing loss, which is very much where our technologies play. What you also see in that space is, a growing base of evidence to say there are other implications for hearing loss, some things that are not always considered as long-term implications.

This increasing relationship between hearing loss and dementia and cognitive decline, increasing evidence coming to the fore that there is a direct link between those two. We know that the global cases of dementia are gonna triple by the time we get to 2050. We know that the number of patients with hearing loss is probably gonna be around 2.5 billion by the time we get to 2050. There is a compelling need to address what is a real public challenge. From a, I guess, opportunity for the company, that's a significant addressable market that provides huge opportunity for growth, not only in the quantum, and you see in the top left-hand table, that quantum of patients is increasing, and particularly in markets where we have well-developed reimbursement structures.

In Europe, you know, more than 30% of patients are gonna be the age of- over the age of 60, and those patients are gonna be living for a lot longer than those patients would have historically. So that problem is, that opportunity is big and is only gonna get bigger. On the bottom left-hand chart, the bubble charts, while those bubbles might look small in terms of profound, severe, and complete deafness, if you just have a look at the quantum of patients, that's a significant opportunity. And we've seen that demographic shift in the sales, our surgery mix today. So that, that pie chart gives you a sense that right now, as, as at the end of the last financial year, 70% of our surgeries are coming from adults and seniors. So we're seeing that demographic shift happening within the own business.

Clear, compelling public health need, we have a solution for that need, and therefore, the opportunity exists for growth. The next slide is I wanted to give you a sense of what, when you develop this referral pathway, what does good look like? And we've done this as an organization before. We've done this in pediatrics, and this is the U.S., and starting back in 1995, going through to 2010, you can see that journey of standard of care, which is now well established in pediatrics. Three sort of key insights from this slide. One is the crucial role that public healthcare policy does in unlocking standard of care. So you see newborn hearing screening as a critical first element in unlocking that standard of care journey.

Public health policy and its implications is something we're gonna talk about a little bit later on. The other piece you see there is this relationship with good, robust clinical evidence that is supporting reimbursement, and if you're supporting reimbursement, you're also then, of course, providing access. Clinical evidence and the importance of that is a key unlocker here. The third piece you see in here is the sustained effort over time. It wasn't just one level of dB, or one level of access. We've built that over increasingly lowering the hurdle to get access to these products. Age is a second piece that you can see. The third important insight is there's a time here. This is not a sprint that gets you across the line.

This is a sustained effort, in the case of the U.S., 16 years before you get to some level of standard of care. I think that's a mindset we need to take into the building of this pathway in pediatrics. And that evidence has translated into a broad adoption across the globe. So reimbursement for many of our developed markets is not a significant barrier. There are opportunities to expand that, but in principle, it's not a significant barrier. And what you do see, for example, there's no age limits now in the case of getting reimbursement in pediatrics. In the U.S., we're right down to nine. That's on the back of that evidence, that's on the back of proving its health economic benefits.

And so reimbursement, by and large, is not a significant barrier to access to cochlear implants. And we see this reflected then in the penetration rates across the globe. This is a selection of key developed markets reflecting hearing loss. This is 0-18, but as you go down the age groups, it's a very similar profile that we have a significant penetration and reflective of standard of care for pediatric patients. So we have a history of being successful. We, I think, understand the key elements of that. So as we tackle the challenge of an adult space, many of these are gonna resonate. There are different barriers or challenges, which we'll unpack in a moment.

Contrast the pediatric penetration rate with adults, and this is a subset, this is seniors, and you can see this vast disparity that reflects a non-standard, very dispersed, very disoriented customer or patient journey to get access to the technologies. This is the challenge, I guess, we face, and this is really why we are significantly investing in developing a referral pathway that's effective. If this is the case, why are we not there? What are those barriers to access care? Probably a significant barrier that's both at the patient level, but also at the physician level, or the healthcare professional, is it's not seen as an important thing to address. It's not seen as a priority within the healthcare space.

On the left-hand side, that's a survey done in the U.S. of 1,000 patients, and asking them to rank, in the next 12 months, what's the most likely health intervention they would take, or the most likely important lifestyle intervention they would take? And you clearly see where hearing loss stacks in, in that space. Right down at the bottom. On the right-hand side, this is a survey with 400 healthcare professionals, nurses, and primary care physicians, GPs, asking them the question of how-- "What's the priority for you for hearing health in your engagement with your patients?" And less than one, or around 1% of those individuals said that this was an important piece to discuss.

So whether you're a primary care physician, and I'll show you some data around our specialists, it's not an important piece, and the same on the left-hand side, not an important piece. We'll talk about why we think that's the case. Again, two pieces of patient feedback. Left-hand side, this is a survey of 15,000 adults across the U.S., aged 50 - 80, asking them a series of questions. One of those is, "Have you had a discussion with your physician around cochlear implants?" So this is awareness of cochlear implants. 80% of patients have never had that conversation. Either they don't know it, or their hearing professional is not aware of it and hasn't had the conversation.

When asked, "When last did you have your hearing tested?" For most of these respondents, it's been 10 years since they've had their hearing tested. Again, not an important or seen as an important piece. On the right-hand side, when you ask these individuals, "What would be the choice or the modalities of treating your hearing loss?" Again, you see cochlear implants is very well, very underrepresented and not seen as something that is front and center at a patient or at a primary care level. So we've got an awareness of hearing health and its importance, probably on the back of not fully appreciating any long-term implications. And then you've got this very low level of awareness of what a cochlear implant is and its role, potentially, in addressing our hearing loss. And so that's from a patient perspective.

If you flick this over to providers or healthcare professionals, this is a summary of some research we've done with ENT. So these are not treating cochlear implant physicians. These are ENTs, primary care physicians, audiologists, think of those as retail audiologists or audiologists in primary care practice or in hearing aid practices across Germany, U.K., the U.S., Japan. There's a very consistent theme of the barriers across any one of those countries. And again, not surprisingly, with providers, awareness is an issue.... It's just not top of mind. I don't think about it. I may not see these patients. I may be seeing them, but I don't recognize who they are. I don't have a lot of exposure, either in my training. I've never been exposed to what a cochlear implant is.

I don't engage in a healthcare environment where cochlear implants are in use. And remember, there are ENTs in this space, in this provider panel. I don't know what would qualify for a CI patient, what they would qualify for, what are the criteria, and so because of that, I don't refer them. There are some secondary barriers that do surface, aversion to surgery. This is the physician's view, not the patient's view, that I don't think this patient is suitable for surgery or would want surgery. High levels of satisfaction with hearing aids. When you do research with patients who are on hearing aids, they have a perceived high level of satisfaction, that there's no need to move to something else, and it's the same with many of the audiologists. They think their patients are well satisfied.

Their patients are telling them they're well satisfied, and so you don't get this referral piece. There's a lack of evidence of how well a cochlear implant would be to a hearing aid. You've seen from Jan's presentation, there is significant evidence to demonstrate that impact, but it's not visible, and they're not aware of it. There are some elements of, I guess, financial barriers here. In certain places, there's a financial incentive to keep those patients and not refer, but it's not a primary barrier in many of these places. So again, consistent with what you see in patients, this awareness and top of mind is a significant barrier across a whole range of people in the space. And so this is reflected at a very personal level.

When we did the living guidelines projects, these were two quotes that sort of resonated with many of the people involved in developing those guidelines. And you're seeing this from a user on the left-hand side, and on the right-hand side, an audiologist, that this challenge of different professionals, inconsistent or no information, the messaging around hearing healthcare makes it very, very difficult for individuals to seek care. In many of the research, some of those journeys are 10, 12, 15 years long before they land up in a CI clinic. And on the right-hand side, there's this view that it's either surgical or technology. It's not patient-centered, in our view. There's no consistent referral, not just within the space, but even between two centers in the same state, there is inconsistent referral patterns.

And so there is this real desire to pull together, a universal view of how we would move these adult patients, very similar to what we have in pediatrics. So there are a number of other barriers, but these are the big ones of just awareness, understanding, and then the referral of how to get to a clinic. So if we understand why we need to do it, and we understand some of those key barriers, then I think, according to our mission, our job is to make more people hear and be heard. What are we doing to help build that? And it's not just us. This is a collaboration with a whole range of stakeholders, of how we might build, that more effective and efficient, referral pathway.

Finally, to sort of make this easy to grasp and get our heads around, we sort of bucket it into four key areas. And the top left-hand side, a critical element in developing that standard of care is the creation and dissemination of key elements of evidence. And that's not just clinical evidence that supports why you would use a cochlear implant and what that does to a patient's hearing performance and their quality of life. It's also increasingly, we're gonna have to demonstrate the cost-effectiveness of this product. As we grow the marketplace, you can imagine payers are gonna be demanding a level of cost effectiveness for the intervention. So that's an ongoing piece, and the more we can generate good quality evidence, we're using that to inform guidelines.

And so we call them living guidelines because they need to be real-time changing as we're getting clinical evidence. You can't wait for these five-year interplays, which used to happen in many other therapeutic categories. You'd wait four or five years, you'd gather the evidence that's taken place, you'd review the guidelines, and then you would issue. I think there's a real acknowledgment that this needs to be something that is very current. And so as we get new evidence, we're informing those guidelines. And those guidelines are right from identification through the referral, through the surgery, including the aftercare, 'cause we know that is a critical element of outcomes, but it's also a key element of growth with capacity constraints.

Enabling those guidelines, you need some sort of healthcare policy to endorse or enable that structure, and so lots of work helping shape healthcare policy at a global level, but most importantly, at a country level. Then you need advocacy. In many other therapeutic categories, the patient's voice is powerful. The patient's voice demanding access to the therapy because it's their health that is the most important piece at risk. That patient advocacy piece is an important element of how we're thinking about building that pathway, and we'll dive into that in a moment. Again, you can have great evidence, good guidelines, a policy that endorses and supports it, but unless people take action, unless somebody refers or a patient demands...

It doesn't change, and so a core part of what we're doing is how are we driving that behavior change? How are we instilling the action with many of these professionals and patients to make the change? So key four building blocks of how we've structured our investment and our time and energy in building that that referral pathway. I'll dive into each one of these in a little bit more detail. So of course, creating evidence, there is significant evidence today. Some of that is reflected in the broad reimbursement we have, but that's not sufficient. We're gonna have to continue to strengthen that evidence, and you're seeing elements of that on the... This is an extract from The Lancet publication, which starts to talk about the link between hearing health and dementia.

Identifies that hearing health is, oh, hearing loss is the single most modifiable risk factor for dementia. So starting to shape some of the, the public policy piece. On the right-hand side, the, in the bottom, this is continued demonstration of the health economic benefits of cochlear implants, particularly in adults in multiple countries. This is our own research that shows when you use a Nucleus 7 with one of our implants, you get this significant shift in quality of life patient, quality of life outcomes for patients, and that's what we want. We wanna see patients embrace and feel that they are engaging with their life. And then there's an important change in our space. Jan spoke about big studies being 50 or 60 people.

These are large, prospective, randomized, controlled studies, so the highest order of evidence that are, again, starting to influence this referral path, and I'll touch about those in a moment. So trying to harness the evidence that's collected 'cause it needs to support the guidelines. So quick deep dive into two of those studies. The one on the left is the COACH study. This is a randomized prospective study being done in the U.K., taking patients who are currently on hearing aids as a control arm and comparing those patients that same demographic of patients getting a hearing cochlear implant, and comparing speech outcomes between you getting a hearing aid versus getting a cochlear implant. That's certainly gonna be the largest and most robust prospective study to position the role of cochlear implants relative to hearing aids.

On the right-hand side, that's just most recently published in the last 6 or 8 weeks. This is the ACHIEVE study. It's a hearing aid study, but it's done in, in patients with mild to moderate hearing loss. And what that's done is compared that group of patients who would then receive, hearing education or healthcare education, and the intervention arm giving you a hearing aid, and understanding whether or not the hearing aid reduces the risk of cognitive decline, based on all of this research coming out. And what you see for a patient population at risk, there's a 48% reduction, a 48% reduction in the risk of developing dementia.

That's the first piece of evidence that's starting to show if you don't take action early on in treating your hearing loss, not only don't you hear, but for the first time, you're starting to see other implications to your hearing loss. And this is an important piece because this is how diabetes and hypertension get visibility, is because you die of a heart attack, or you develop atherosclerosis, or you develop this diabetes, you know, blindness, amputations. There are real consequences to not treating it. Up until now, that's not been the case with hearing loss. You're gonna go deaf, you get a hearing aid, people are gonna speak louder. Now, if I'm telling you that this is an impact on dementia and cognitive decline, that's a compelling reason for a patient to take action. There are massive costs associated that, with that from a public healthcare policy.

There's an incentive for healthcare policy to change based on those implications. So while this is a hearing aid study, and it's in a different level of hearing loss, it's a significant piece in shifting the dialogue around the importance of hearing health. So, that's the ACHIEVE study. I gave the results without showing the slide, but there you can see that there is a significant impact over three years for a patient population who are at risk for dementia. Significant shift in how we would frame hearing health and hearing loss. We're getting that evidence. We've got to put that into guidelines. There has historically been no global set of guidelines, which there are in places like hypertension, diabetes, rheumatology, asthma. All of these, there are global guidelines, and so we've started on a journey in doing that.

What you can see is, we published an international consensus paper, where we gathered a small group of clinicians in our space, led by our clinical team in developing a consensus paper. But it was just that, it was a consensus paper. It wasn't guidelines. And so we initiated a project to. We initiated a study in developing living guidelines, where we gathered 50 individuals from across the globe, audiologists, surgeons, patient advocacy, in building what we think is, what we know is the very first global set of guidelines from early identification right through to treatment and rehabilitation. That's just rolled out.

I guess the important piece here is it's great to have a document, it's great to have a group of people who have built that. The change only happens at a country level, and so what we're seeing right now is a number of our key countries, then, utilizing that document and driving some of those changes and discussions at a country level. I'm not gonna go into a deep dive here, but this gives you a sense of what the different types of actions some of the key countries are taking in bringing these guidelines to life, shaping policy, shaping their own guidelines, driving awareness, engaging consumer or patient advocacy groups. So that, that third piece around patient advocacy, here are some high-level focus areas.

So we obviously working with the WHO at a high level, but we have some key countries where we're actively using WHO to drive policy change resolution, and that's an ongoing relationship we continue to have. Over the last three or four years, we've been actively driving members of patient advocacy groups to unite and have a single voice. There are a lot of patient advocacy groups in CI. The problem is they're very diverse, very discrete, very decentralized, and there's no powerful single voice they can shape. And so we've worked with a few individuals to develop this CIICA, which is really a collaboration of a number of different patient advocacy advisory groups to drive the voice of customer much, much more louder.

Importantly, we've got research collaborations on a product and technology side, but we do have these two key relationships with public health academia. So we've got a group here in Macquarie that are working on a number of longitudinal epidemiological studies. We've got Professor Frank Lin in Johns Hopkins, who, of course, is a key architect of the ACHIEVE study, but is also looking at driving changes to public health policy. So that academic relationship is important for credibility, but also because they are public health policy drivers. And then we've got a number of versions of collaborations pulling together different groups.

So this is an example, and I'm sure Lisa will dive into this in a moment, where we've got policymakers, hearing aid people, CI surgeons, pulling together, and in this case, in the U.S., called the Hearing Health Collaborative, in pulling together a united view of hearing health and helping to shape policy. That has to be driven by professionals and individuals, but we certainly play a role in helping enable that, and there are variations of that across the world. There's one in Australia that is up and running as we speak. So very high level and a very quick view of some of the key areas we're helping shape advocacy.

And as I said, it all doesn't happen unless people make a change, and so there's some really tactical elements of working with individuals around our hearing aid partners, where we're working with them in helping identify who would be, how they would refer, who they would refer to. We're building educational elements that we can go into. This is an example in the U.K., where we're working with the NHS in training the hearing aid audiologists in the NHS of what does a cochlear implant patient look like? What is that? What's the surgery involved? Who could you refer to? And hoping that starts to accelerate referral. And then we've got a number of platforms where we use those platforms to disseminate the latest information, sharing of the activities across the globe, so that there's a transparency and an access to information.

And the Adult Hearing Platform is just one example of that. So those are the four key elements of creating evidence, putting guidelines together, ensuring that's enshrined and supported by advocacy and policy, and then driving behavior change. And if we get those four right, then we should, to the right-hand side, have a development of standard of care. And again, the call out being a sustained effort that has some short-term wins, but mostly sort of pay off over the medium and long term. And I'll stop there and take any one or two questions. Yes.

Speaker 13

Dean, you've spent an awful lot... You spent most of your time talking from what I call the top-down approach. The research innovation, the audiologists, the professionals, et cetera. I'm very keen to hear the speaker from the U.S., because the previous head of U.S. and Cochlear in the United States, who became a short-term CEO, talked about developing groups of CI recipients, who then would talk to potential CI recipients and explain to them the benefits, and your colleague, with his double cochlear, demonstrated that very well. I wonder the degree to which Cochlear can, should, whatever, start working from the bottom-up approach. People who are my age, who are suffering a noticeable deficiency in hearing, who go to an audiologist, who says, "I've got the product for you," but having been aware of Cochlear for 12 years, I'm a little bit dubious about jumping into that realm.

I'm now going to go to my GP and get a referral to somebody who knows more than just how to sell a product. But the question I'm asking you is: what can Cochlear do to increase, to motivate the hearing impaired who don't know and are not getting any advice on where do I go now?

Dean Phizacklea
SVP of Global Strategic Marketing, Cochlear Limited

Yeah, and very good question. Two responses to that. So one, you can imagine there's a whole range of things we're doing, and it's hard to capture them in a single slide. So we've got two pieces. We have broad awareness strategies in place, and I call them consumer strategies in place. And that's not a strategy to connect you directly with a clinic, but it's to inform you of the various options in hearing health, why cochlear implantation is an important piece. And we're about to embark on a pilot, in fact, in the U.S., on what I would call broad scale consumer awareness. And there are variations of that across different countries. The other piece that's not reflected, but is an integral part, is a volunteer network. So we are...

I think Roger clearly articulated the impact his brother had, but not everybody has, I guess, access to that intimate piece. So we have for a long time initiated out of the U.S., but is replicated in many countries, a volunteer network, where we work with a group of passionate CI recipients, and we actively match those to people who we feel would be in a similar space, reflective of their journey, and get them to engage. And we see that has a significant impact at that last phase. It's really at a different time in the space. I've come through. I'm now fairly ready to go, but I really want to understand what that is. There's a real synergy and impact in that personal relationship, and so that's a piece that's reflected in many other places.

Dig Howitt
CEO & President, Cochlear Limited

Okay. Thanks. Thanks, Steve. We're going to take a break now till five past eleven, and then we'll come back with Lisa and Greg in Q&A to finish up. There's some tea and coffee outside. Thank you. Back at five past eleven, please.

Speaker 14

I started losing my ability to hear music 25 or 30 years ago, and I quit listening.

Few things in life have impacted me as much as my hearing loss.

It's so frustrating when you can't hear, because you just want to be successful.

I had a harder and harder time communicating.

I had disengaged. I was well on the way of becoming a recluse.

It finally came to the point where I had the strongest hearing aids available, and they still weren't doing it.

I knew that I had to somehow repair my hearing.

Lisa Aubert
President, North America, Cochlear Limited

I had absolutely nothing to lose and everything to gain.

Speaker 14

That's when I decided to get a cochlear implant. Now I can hear like never before.

I was experiencing something that was totally different than I had ever experienced with a hearing aid. The world truly started to open up.

It's phenomenal! I hear so much.

It's giving me more freedom and confidence.

I'm becoming part of the community again.

I want my independence back. I won my life back.

The sounds remind me that I am not defined by my hearing loss. I can do anything I put my mind to.

To do what I love with the people that I love, that's a big win for me.

Dig Howitt
CEO & President, Cochlear Limited

Okay, welcome back. Thanks for coming back in promptly. Now I want to introduce Lisa Aubert. Lisa is our President for North America, been with Cochlear for 29 years and worked in clinical roles and sales roles across U.S. and Europe. And prior to being president for North America, was Vice President of Sales for North America. So a very long history with Cochlear and deep knowledge of our market, our customers in many markets, and obviously, the product and clinical aspects. So, Lisa, great to have you here.

Lisa Aubert
President, North America, Cochlear Limited

Thank you, Dean. Great. Well, it's certainly a pleasure to be with all of you this morning, and thank you very much for coming out for this day. I am going to be giving you. So Dean gave you a global perspective on hearing healthcare, and I'm going to kind of fine-tune that a little bit and give you the U.S. perspective. We'll be going through this discussion in a few different areas. So looking at our evolving market landscape. So again, as Dean shared with you, and as you can imagine, we too are evolving into a more seniors market and segmentation. We'll share with you how we are growing awareness of hearing healthcare in the U.S.

And with that growing awareness, how we are broadening our indications to make sure that people who need this technology can get the technology, and also increasing access, so it is easier to find a provider. And then we'll land up on our payers landscape. So again, as you're probably well aware, and Dean also laid out, in the U.S., we definitely have a growing population of seniors, and this is defined by people of greater than 65 years of age. Today, in the United States, we have about 55 million seniors. That number is growing at 10,000 per day.

So over the next 15 years, we are going to see a big growth in this segment of the population, leveling off a little bit after that, but certainly, building our total addressable market, 'cause as we know, there's also a higher preponderance of hearing loss in this aging population. So if we look at our prevalence, what we do see is a declining birth rate in the United States. And so what you see in the purple bars is the prevalence from 2015 to 2022, and the yellow bars is the projected prevalence in the different segments, so pediatrics, adults, and seniors. With the declining birth rates, we see that that prevalence is actually dropping off for children, staying steady through the years with adults, and as we would expect, growing in our senior population.

Now, Dean presented a senior penetration of about 7%, just over 7%. What I'm showing here is all of our segments. So pediatrics, of course, increase that penetration a little bit, but we would have about 7% in seniors and about 10% penetration overall. So lots of opportunity. That's what that tells us. So with that opportunity, we have been working very hard to increase awareness and make sure that people who need our technology have access to it and are able to get the technology, and that they're aware of it. So a number of years ago, about 10 years ago, we launched a direct-to-consumer marketing strategy or DTC strategy. We did this both in print as well as digital.

We partnered with the largest senior publication in the U.S. and a senior organization called the American, sorry, the American Association of Retired Persons, AARP. We have been placing editorials in AARP for a number of years, and these are some of our surgeons. So we highlight one of our surgeons. They're a one-page ad, and they talk about the importance of treating hearing loss and what a cochlear implant, the benefits of cochlear implant, how you can access them, and that Medicare actually does cover them, which is very important, particularly to this population. So about a year ago, we've been doing these ads for a number of years, and we placed them a few times a year. So a few years ago, we partnered with AARP, and we did a survey of their audience.

So they have a readership of about 12 million people. We had 600 respondents between the ages of 50 and 70, and we asked them questions around cochlear implant knowledge. So what you can see here is in this group, which is a very informed group, I would say, more informed than probably the general population, which is what the survey that Dean was referring to. You can see that the awareness and the understanding of cochlear implants is actually not too bad. They know a little bit about what an implant does, who should be treated, so they understand the indications. And they understand that there's not an age barrier, which can definitely be a myth when it comes to implanting patients in this population.

Within this group, they are actually seeking hearing treatments, and they're seeking to understand their hearing loss, probably, I would say, more than maybe the general population and the data that Dean presented. So this has been a direct result of our DTC efforts in the United States, and it's really great to see this paying off. Some of the anecdotes that we hear is we will have our surgeons and clinics tell us that they have patients that actually bring in those editorials after receiving their publication, and they wanna sit down, and they wanna talk about whether or not a cochlear implant is the right thing for them. The other aspect of our DTC is really on digital, so you know, through all of the digital means that are available to us.

What's exciting about this is we are seeing that seniors are becoming more digitally savvy, and they are seeking out information through these digital channels. Again, it can often be a myth that this population is not online, they're not on their phones, they're not on social media, but actually, research would tell us that they are, and we definitely see that, that direct effect. About 25% of all of our surgeries now in the U.S. can be attributed to our DTC efforts, and 70% of the leads that we generate are actually within the senior population. Another trend we're seeing is that once patients understand that a cochlear implant could be an option, they're actually moving through that process a bit faster, so they're not sitting on that decision.

And part of that, to go back to the question the gentleman had earlier about volunteers and connecting people who have gone through that experience, we have about 1,400 active volunteers in the United States, and we work really hard to make sure that they are connected with people going through the journey. And we have seen that that does speed up their decision from the time they know about an implant to go forward and get the surgery. So that's been a very positive aspect, too, of our direct-to-consumer efforts. So Dean mentioned touched on lately the Hearing Health Collaborative. So how are we bringing standard of care to life in the United States, and what are we doing about it?

It's quite an arduous journey for people that have a hearing loss, even getting to hearing aids, but certainly getting to cochlear implants. As Dean said, there really is no standard of care for adults. We know that, you know, for pediatrics, that can be very different, but for the adult population, there isn't a standard of care. Back in 2021, we did form a group called the Hearing Health Collaborative, or the HHC. This is a group of multidisciplinary professionals, so they come from the hearing healthcare space. There are patients, there are also geriatricians. We are trying to reach out beyond just our own bubble to work together to really build a blueprint for what hearing healthcare needs to be and get patients treated faster when they need the technology.

So there are three priorities that this U.S. group is working on. Absolutely what Dean was sharing with you about the living guidelines. So this is a group that will take those living guidelines, and they will start to embed them across the treatment path. But three of their priorities that they're working on right now is, number one. Trying to establish, like, a vital sign for hearing. So when you think about this, we have this in other areas of medicine. People generally know what a healthy blood pressure reading is, 120 over 80. They get concerned, their GP gets concerned if it goes above that, and they start to wanna seek treatment or adjust their lifestyle. Same with vision, right? That's the easy one. I'm here in Australia. I'm from the U.S.

I could talk to anyone in the room, we could talk about 20/20 vision. We know what that is. We don't have anything like that for hearing loss. So together with a group at Johns Hopkins, they're working on establishing like a hearing number to make this very easy for consumers and professionals alike, to understand what is a more normal level of hearing and what may not be, and people want to seek action. The second priority is really developing very consistent and consistent ways to report hearing loss. Again, if you think of different, medical and healthcare areas, so if I use cancer as an example, cancer is staged, and again, I believe that's fairly globally.

You might call it stage one to stage four, or level one to level four, but as a patient and as a healthcare provider, you understand what that means. You understand what the treatment pathways will be at the different stages. You understand what that escalation pathway may be once you get up to a higher stage of cancer. We don't have that in hearing healthcare. So this group is also looking at how do we start to establish that? So again, it's very easy for both the patient consumer to understand, and healthcare professionals know when to act, how to act on the treatment, and when to escalate to something like a cochlear implant. The third area that they're working on, and again, all contributing to developing the standard of care, is really securing an evidence-based pathway for treatment.

As I mentioned, it's very convoluted. It's very hard right now for a patient to navigate that. They don't really understand what hearing loss is, when they should act on it, what the treatment options are, and how to even get to a provider. This group is really focusing on that aspect and making it streamlined, and again, consistent in having a clear standard of care pathway, so someone is identified with a hearing loss. Both the consumer and the healthcare provider can understand what they need to do, when they need to do it, and how they refer a patient on for access. Those are the three key priorities right now, together with the living guidelines with the Hearing Health Collaborative in the United States.

So we know we have a lot of patients out there, but we also know that we need to continue to work on indications. We need to be able to get treatment for our patients, so we need providers, and we need to make sure that we are partnering across the different channels that our patients come into contact with for their hearing healthcare. So if you look at our total addressable markets, as we know, it is large. We've talked about penetration, we've talked about prevalence. If you take the more traditional patient base of severe to profound hearing loss, so this is defined. These are patients who are about 60+ years of age, with a hearing loss of 65 dB or greater.

There's about 1 million people in the United States that would fit that category, that really would benefit from a cochlear implant. A number of years ago, we expanded that indication to include patients that had more normal hearing in their lower frequencies, and then really sloped down to a severe to profound hearing loss in their higher frequencies. That added an additional 1.5 million people to that addressable population. Most recently, we got approval from FDA to include patients that have a single-sided deafness . Sometimes it is sudden, and when it is sudden, patients definitely do want to act quickly. Now, this did add a smaller amount of patients to our addressable market.

However, these do tend to be patients that end up in the medical channel, so they end up with the right people right away, and they tend to act with urgency, because they want treatment. Now, before this indication, these patients are generally treated with a hearing aid, with a special type of hearing aid that would cross the sound over from their bad ear to their good ear, or they've been treated with a Baha or an Osia. Now, not to say that they're still not treated that way, absolutely. But definitely our professionals see the benefits of treating these patients with a cochlear implant, and the patients are seeing it. So we are seeing this as an expanded opportunity and has been driving growth over the last 12-18 months.

So this was a survey from the American Speech and Hearing Association, and they asked people, "Who is your trusted source for information when you're seeking out hearing healthcare treatments?" And the medical channel, definitely physicians who specialize in hearing issues, is their number one trusted resource, with audiologists being second. So that's great news for us because that's where our patients end up. They end up in the medical channel with those, with those physicians who specialize in it or generally with audiologists. But it also indicates to us that we need to be building our partnerships and working within and across all of the different referral channels that we have, that our patients will end up in. So from the hearing aid retailers, all the way through to the medical channels, we need to be there, and we need to be partnering.

So as I was saying, we do have—we know we have this big addressable market, but we need to make sure that patients have access and they have providers when they need them, when they're ready to seek the treatment out. We definitely have seen a growth in our providers over the last 10 years. And this has been a growth from moving out of academia into private practice or bigger medical centers. It's also been a function of us developing our Cochlear Provider Network, which I'll speak about in just a moment. And it's also been a function of newer in career or surgeons actually, who have been in their career a while, who have, maybe just been doing more general ENT, deciding that now they want to offer this technology within their practice.

That has been a really exciting area for us to see. So again, taking it out of academia, sorry, and really making it mainstream. And we find that surgeons are getting on board with this. And so what we have seen over the last five years is our surgeons who have been in practice for less than five years are actually growing faster than our more established surgeon. So actually opening up access and adding to growth in our markets. So we're very excited about that. We do a lot of partnering with them to make sure that they're trained and able to provide a very high quality of care. So I mentioned our CPN, our Cochlear Provider Network, and this was something that we started to experiment with about 10 years ago.

This was a way for us to get a little bit out of that medical channel, go directly to the audiology channel, where we know a lot of patients are sitting because they're getting fitted with hearing aids within this channel, and partner them with a surgeon, partner them with a medical facility. This opens up care in the community, so closer to home with a trusted partner. So remember, the second most trusted partner is an audiologist, probably the one that they've had their hearing care delivered from for a number of years. So they trust them. So it's kept them with their trusted source. It's also allowed them to have care closer to home. So through the years, we have actually seen a big growth in the number of providers that are within our CPN network.

We're starting now to really focus this network on looking more into their databases because they have a lot of patients that they're still not referring, and referring them out to their professional surgical partners, for the treatment. And then they, they have the patient back, and then they look after all of their, their aftercare that they need. So that has been a very successful program for us. And like DTC, we do try to experiment and be a test ground in the U.S., and then be able to replicate and share that out into other markets, which we're starting to see now. Okay, there were some questions earlier about the treatment path, and as I've mentioned, it is quite arduous and very difficult. You don't need to worry about all of the detail on the slide.

The upper part is really from a diagnosis of a hearing loss, a referral from a hearing loss, and getting fitted with a hearing aid. I think the other uniqueness about us is that, you know, generally, that's a self-diagnosis or a self-referral. You know, somebody starts to you know have some challenges with hearing, or one of their loved ones is getting frustrated with them, and then they, you know, off they go to find some help. So it can be hard for them to even get a hearing aid, but then they drop down, hopefully, if they need a cochlear implant into that middle part.

But what I want to focus on is really the bottom part of that treatment path, because that's an area that we have been focusing on for a number of years to try to drive some efficiency, to open up, access and open up appointments for patients, who need to hear. We find that our clinics spend more time helping patients who already hear, and they need to be spending more time helping patients who can't hear. So we've been working on evidence-based clinical models, to streamline that process. So if I zero in on that bottom part, generally, after surgery and after activation, patients will come back 5-6 times, for programming, and those appointments can last between 1-3 hours or maybe even more, depending on where you go.

So we have been looking at how, together with some of our big, leading academic centers, what would happen if we streamline that? And can you still provide the same quality of care with less appointments and in a shorter amount of time? So one of our big academic centers that we partnered with actually looked at this. So they, they streamlined their protocol. They reduced the number of visits, after activation from 5 to 6, down to 3. The other thing they did was, instead of seeing patients back annually thereafter, and remember, we have patients for a lifetime. They stopped the annual visit, after that, that last 12-month appointment, and they only see patients back if necessary. When they did this, they immediately opened up about 10 weeks worth of new appointments.

So these are appointments, again, that they could see patients who can't hear yet and spend less time with patients who need to hear. Now, this is about an 80/20 rule, right? We all know that there's going to be more complicated patients for whatever reason, and they're gonna need to come back a little bit more. But generally, what we're seeing is there's now a movement to start to look at these more evidence-based, patient-centric, streamlined protocols. And we're finding that our larger academic centers are really leading the way. They're getting on podiums at our conferences. They're doing learning events for their colleagues so that they can help them streamline this and really open up access for new patients.... Now, what's Cochlear's role in this other than partnering and trying to help with the evidence?

Between our services and our products that Jan touched on, we are actually able to support them every step of the way, to be able to deliver this quality of care that is patient-centric, either in hospital or as Jan said, at the patient's home. Good quality of care when and where the patient needs it. So we have some services on the front end that we can help both the clinic and patients as they're going through that journey to get a cochlear implant. And what we're working on now is embedding all of our Connected Care tools into that protocol that you saw earlier.

So instead of maybe seeing a patient at six months, you could do a remote check, and you could triage that patient, and you could then see whether or not really that is the 20% that might need to come in for a visit, or it's indeed the 80% that is doing just fine, and you don't need to make them, you know, have the journey in, and you can open up that slot for a new patient, for example. So this is really the fun bit for us. This is great in the region where we can take the products that our R&D team make, and we can really bring them to life and embed them for the betterment of our patients in our clinics. Okay, so I will finish up on our payer landscape.

So we are in a very favorable position right now with payers. About 60% of our patient base has private or commercial insurance, and just over 30% are on a public payer, so either Medicare or Medicaid. I think most of you know, Medicare is our federally funded healthcare program for those 65 years and older. About 99% of our patients are covered, like I said, over health insurance plans that are commercial. And we have 100% coverage for both our Medicare and our Medicaid, our public funded system. And this is for bilateral sensorineural hearing loss. I mentioned earlier about expanding indications. So, I think it was maybe Dean who'd mentioned, just because you get something approved by your regulator, doesn't mean the payers are gonna pay for it.

So our market access team and health economics team works very hard to make sure that as we're expanding these indications, our patients have the access because insurance will cover it. So currently, we're working on our SSD indication and coverage, and we have over 50% of our private payers who are paying for coverage for SSD patients. And we have Medicaid, which are state aids starting to cover it for children. Currently, Medicare is not covering SSD for patients who are 65 years and older, but that is something that we are currently working on. So very favorable payer landscape. We need to work very hard to keep it that way. We do not want finances, and we don't want this to be a barrier for our patients.

Okay, so to wrap up, as we can see, we do have a growing senior population, which is contributing to our total addressable market, so big opportunity. What we need to do now, so we have growing awareness for sure. There's a lot of work to do. We're working on standard of care. We really need to get people to start acting with urgency to treat their hearing loss. And as we know, and as Dean went over, you know, that is definitely one of the barriers where people just don't prioritize their hearing loss like they do other health issues. I think some of the data that is coming out around cognitive decline, loneliness, falls, those sorts of things will definitely help us.

But, it is something that we're starting to focus on with the growing awareness that, okay, but now you have to act, and you have to treat your hearing loss with urgency like you would do any other healthcare issue. We have a growing evolution in our referral paths, so we have been partnering for a long time, like I said, across all of the channels. So from hearing aid retail all the way through now to the medical channel, working on trying to streamline that. That's part of the Hearing Health Collaborative and the work of standard of care. As Dean said, that, that's a long burn. That definitely will take time, but I think as you can see here, with things like our direct-to-consumer strategies, they do start to pay off.

So we are definitely here, in it for the long game, and we'll continue to invest so that we can grow the awareness and really get more people hearing and, and, help them be heard as they're going through their journey. We have great, payer coverage, and we'll continue to work on that as we look towards our future products. Definitely getting better at working together with R&D very early on to make sure that when they hit the market, they're actually covered, and our patients don't have to wait for that coverage. So currently, like I said, we're in, we're in a good position there, and, we're gonna continue to maintain that position and work hard to do so. Okay, so with that, I wanna thank you very much, and, I think we have some time for questions.

I did a few minutes early to make sure we did so.

David Stanton
Head of Healthcare Equity Research of Australia, Jefferies

Thanks. It's Dave Stanton from Jefferies again. Just following up on that previous question, I guess, could you give us sort of some metrics around the expansion, maybe in the Cochlear Provider Network? Just where it's come from, where it is now, and potentially where it's going? Just to give us an idea of, you know, how you're increasing sort of the volume opportunity per clinic, and thank you.

Lisa Aubert
President, North America, Cochlear Limited

... Yep, sure. So as you can see from our dots on the map, you know, it's definitely something that has expanded over the last number of years and something that we have focused on. So we are starting to see, you know, there's an ever-growing number every year of patients coming through that network, getting referred and getting treatment. It's a larger contributor than it ever has been before to that patient referral and entering into implantation. It works best, we're finding, when you have a very good partnership with a surgical partner or surgical facility.

So we're starting to see newer and clearer private practice doctors actually going into practice, not necessarily hiring their own audiological care or audiologist, and using that Cochlear Provider Network really as a means for them to grow their practice, and get the referrals in and develop that partnership. So we're seeing that now. We're actually honing in, I think, a bit better on the profile of people that we need to partner with, and we are also looking at digging into the providers we have currently in our network and how we help them identify more patients rather than expanding. You know, we expand it when it makes sense, so like I said, when we have a surgeon who wants to partner, that's a really good opportunity.

But, you know, now we're looking at the quality, you know, more the quality, of the partners we have and how they can refer more patients into the surgical space.

Speaker 13

I'm fascinated by the data that you presented about the 10,000 increase per day of over 65s. If you then look at that path, and you overlay the path of Cochlear providers, is it the same path? Have the suppliers, the providers of care, grown-

Lisa Aubert
President, North America, Cochlear Limited

Yeah

Speaker 13

in line with the anticipated demand for their services? If not, then obviously more work needs to be done with the providers.

Lisa Aubert
President, North America, Cochlear Limited

Yeah. Yeah, it's a great question. Up until now, I would say yes. However, when you look at that trajectory, no, probably not, and our data would tell us, both with audiologists and surgeons, that if we don't start doing something and growing more, more surgeons and providers, then they won't meet the demand. Now I'm not saying that's gonna happen next year, but we do see that coming in the future. So we already are starting to look at that and consider that, and look at different business models. One in terms of, you know, what can we take out of the system, so it's not overburdened in terms of the care, but also, how do we get more general ENTs to start doing this procedure?

How do we simplify it through our products? What can we do to help them with training? What we've generally seen in the United States up until more recently, is this is a very specialized field of medicine. It's generally neurotologists that are putting these devices in, and that's a very small group of people. We will run out of them. So we are trying to expand into more general ENT surgeons, partner to train them up, and, you know, get them out there providing the care that we need. But yes, we're well aware that we do need more providers. But it'll be a balance of more providers and again, simplifying the technology. What can we take out of the system?

Saul Hadassin
VP and Equity Analyst, Barrenjoey

Hi, it's Saul from Barrenjoey. Lisa, just a question on that established clinical pathway. I was just interested to know, with the older adult cohort that are presenting with sensorineural loss, is it common for someone to present for the first time with such profound loss that they need to go straight to having referral for an implant? And if so, is that pathway now well delineated that they don't go through the hearing aid setup and failure, et cetera, and then ultimately get referred on for an implant?

Lisa Aubert
President, North America, Cochlear Limited

Yeah. So generally, our patients are wearing hearing aids before they need an implant. I mean, they're, you know, we know it's a progressive disease state, and so they generally go through numbers of sets. But what does happen is they sit, they can sit at that end stage, if you will, of hearing aids for a very long time. I would say it's the rare patient who shows up, never wearing hearing aids, but has a severe to profound hearing loss. However, it's the... The journey can still be really difficult. You know, even if you hadn't been fitted with hearing aids, it can be very hard for you to understand what that treatment path is.

So, you know, hence the work with standard of care and really trying to make that easy and consistent and embedded into the medical channel. You know, it is, as Dean was saying, people don't consider this a disease state, and that's really what we're trying to change. They need to, and again, just going back to acting with urgency, but it's still pretty convoluted in what the standard of care is really trying to address.

Saul Hadassin
VP and Equity Analyst, Barrenjoey

Okay.

Lisa Aubert
President, North America, Cochlear Limited

Okay.

Dean Phizacklea
SVP of Global Strategic Marketing, Cochlear Limited

Thanks, Lisa.

Lisa Aubert
President, North America, Cochlear Limited

Thank you.

Dean Phizacklea
SVP of Global Strategic Marketing, Cochlear Limited

Okay, and now on to Greg for our last presentation before we open up for Q&A. So to introduce Greg Bodkin. Greg's our Senior Vice President for Global Supply Chain. Long career in supply chain manufacturing, process improvement. Joined Cochlear in 2007, in our leading our procurement logistics and have been head of our global supply chain since 2015. Greg?

Greg Bodkin
SVP, Global Supply Chain, Cochlear Limited

Thank you, Dean. Good morning, everyone. So today we'll have a look at how we think about our global supply chain, and some of the detail behind it. Firstly, just a quick overview of where our supply chain is located around the world. In a moment, I'd like to show a video of each of these operations. So I'm not going to go into the detail behind them, but suffice to say that we do have a very global footprint, and we operate this network as a true global network. It's one of our core strategic advantages because it helps us manage supply continuity, manage supply risk, and make sure that we can get products into our customers at the right time every day.

So we're very proud of what we do across the supply chain. A couple of emerging operations, obviously, in China, and even Malaysia. But our core is still here in our two plants in Sydney, and in Brisbane. But, yeah, each day, the philosophy that underpins what we do, in our supply chain is firstly a very, very tight integration and often co-location, with our R&D colleagues. It's extremely important. It helps us improve and maintain the quality of our products, but also gives us that speed to market. Having professionals connecting and collaborating together is a really, really critical thing in getting those new products to market. We consciously own and vertically integrate really key manufacturing process steps, that are critical to either quality or managing our supply risk.

And we've taken some very big decisions recently to make sure that that's locked down. We drive lean technique and methodology through our operations to get the efficiency and the continuous improvements. That's how we aim to maintain that gross margin and achieve our gross margin aspirations. We progressively introduce automation as scale and technology allows. Technology is not always an enabler for things, but as we grow and we get bigger and as our demand grows, we do need to keep adding automation into our processes. We have very, very deep third-party supplier relationships. So people often think about our own network, our internal network, but equally, we have a very, very large base of third-party suppliers that are critical to us being able to maintain our supply chain and keep that continuity.

We use inventory to buffer our supply chain risks. Right? Inventory is a friend, more so than a foe. All right? I know people look at days cover, and they look at turns, and they look at cost of carrying, but I can tell you that in the last three or four years, inventory has been a great friend to this organization and certainly an even better friend to our customers. So right now, I'd like to actually show that video, which will actually take us around the world and have a look inside each of our operations.

Speaker 14

Today, we invite you on an immersive journey through Cochlear's global manufacturing and logistics sites in Australia, Sweden, Malaysia, and China. Together, they work as one global family to bring Cochlear's life-changing hearing solutions to recipients around the world. Our journey begins in the iconic city of Sydney, where our Macquarie site serves as Cochlear's global headquarters. Positioned close to Macquarie University and the Australian Hearing Hub, it allows us to collaborate with leading researchers and clinicians, putting Cochlear at the forefront of advancements in hearing solutions. Established in 2010, our headquarters were built to meet the growing demand of Cochlear's products. The Macquarie site is now home to dedicated team members and researchers.

G'day, and welcome to Cochlear's global headquarters here in Sydney, Australia. Now we're in our Macquarie University facility, where we host one of Cochlear's global manufacturing and logistics operations.

In Macquarie, we have over 300 team members across two shifts. In the clean room behind me, we finish electrodes and implants before sealing and shipping. Let's go inside and have a look.

These clean rooms are where the most critical manufacturing processes take place. By maintaining a controlled environment and gowning procedure, our clean rooms are 12 times cleaner than that of an operating theater. Skilled team members perform many functions, primarily the joining and assembly of critical components, such as electrodes for the Profile, Nucleus, and Kanso implant systems. Our non-clean rooms support various aspects of operations, from molding and testing to tooling and logistics. Our headquarters, alike only a few sites, houses both manufacturing and R&D under the same roof. This enables seamless collaboration with engineers and researchers to develop the next generation of hearing solutions. This location is only the beginning of our global journey. As we visit our other Sydney site in Lane Cove, we arrive at the birthplace of Cochlear manufacturing and logistics for the multi-channel implant.

Our history of manufacturing remains within these walls. Here at Lane Cove, you will see a combination of old and new. We have rejuvenated and refreshed many areas since renting a few buildings in 1982, to when we purchased these buildings in 2017.

This historic site is where Professor Graeme Clark's groundbreaking research paved the way for the world's first multi-channel cochlear implant and was the first site to embrace our revolutionary lean manufacturing and flow line processes, which allow us to produce a wide range of products, including sound processors. This advancement significantly reduces manufacturing time and has since been introduced throughout our global network. As we progress on our journey, you'll learn how each site plays a vital role in supporting one another throughout our manufacturing and logistics family. This leads us to our next site. Nestled among the beautiful coastlines and a golden skyline sits Cochlear's Brisbane site.

Hello, and welcome to Cochlear, Brisbane. We've been manufacturing on this site for decades, and each year we continue to grow the site and its capabilities. With over 200 employees on site, we provide 3 core competencies. The first is electronic assemblies for implants, the second is printed circuit boards for sound processors, and the third is system accessories like coils and cables. Altogether, that's over 300 different stock items.

This site, too, embraces our lean manufacturing principles and specializes in producing printed circuit boards, coils, and coil cables. These components are fundamental to the assembly and functionality of our products. Beyond manufacturing, Brisbane also serves as an internal supplier of essential components for sites around the world, proudly distributing over 500,000 final products per year. Departing Australian shores, we arrive in the historic city of Gothenburg, Sweden. This site embodies the engineering standards Cochlear is known for and is the heart of our acoustics business.

Welcome to the M&L site in Gothenburg. Almost 300 people are working in this building. 65 of those are within supply chain and 25 within manufacturing and logistics. The M&L department has three main focuses: the assembly of the Baha actuators, the distribution of wireless accessories and the sterile assortment, and the final packing for the acoustic products.

In this clean room, we find dedicated team members specializing in Baha actuator assemblies. Each component is assembled by hand and then tested by automated equipment, ensuring our commitment to quality. Operating as a critical supplier of acoustic components, the warehouse follows Cochlear's logistics methodology, ensuring the seamless movement of components no matter where they are needed throughout our global network. Moving to the vibrant city of Chengdu, China, we arrive at Cochlear's recent addition to our family, and one we're incredibly excited to introduce.

Welcome to Cochlear Chengdu site. Our facilities are set up to allow for hundreds of manufacturing and logistic employees to work here in the future years as the volume demand continues to grow.

This site supports operations around the world. Everything here has been engineered for scalability, accommodating a growing workforce to meet the rising global demand for our products. Inspired by our Sydney headquarters, the Chengdu site houses a manufacturing floor spanning 2,000 square meters, with clean rooms dedicated to Profile, Profile Plus, and potential future Nucleus and Kanso portfolio, including non-clean rooms for sterilization and sound processor final assembly. Following our logistic methodology of goods incoming and outgoing, components are scanned, tested, and then stored, ensuring efficient movement from the warehouse to manufacturing and the return of finished goods for shipping. The site also includes state-of-the-art surgical and rehabilitation facilities. These innovations excite us for the future and our ability to deliver the gift of hearing to people around the world. Arriving at the final stop on our journey is the city of Kuala Lumpur.

Known for its diverse culture and towering skyscrapers, it's home to Cochlear's global repair center. This site consolidates repair, manufacturing, and shared services activities from over 15 different sites worldwide.

Welcome to Kuala Lumpur, Malaysia. In this vibrant city, we have our expanding manufacturing facility. We are growing since 2016. We have over 200 employees on site with two core competencies. They repair and manufacture Cochlear sound processors for global market.

Skilled team members diagnose and address issues with sound processors, completing thousands of product repairs each month. The recent expansions have enabled the manufacturing of our Nucleus, Baha, and Kanso processors, further allowing us to meet our global needs. It all starts with our logistics methodology for components and product repairs. Shipments are inspected, organized, and transported to the repair floor. Here we perform soldering, conformal coating, assembly, various testing, inspections, packing, and finally, return shipment. This completes our global manufacturing and logistics journey.

Greg Bodkin
SVP, Global Supply Chain, Cochlear Limited

... So I hope everyone got a good appreciation of our, our network around the world with that short video. I just want to dive into three specific areas in the time left, and the first one is around implant reliability and how we, we manage the supply chain to deliver that. So the first one is really around people and quality. Yeah, one of the critical things that we do, do is the team member selection, onboarding, training, and assessment. You know, the work we do is quite complex, it's quite difficult, and we have to find the right people. It's around three months to have a production team member just gain the basic competency before we actually let them on the line and start making commercial product.

We focus on processing quality controls and a quality control system that's very compliant, and quality is something we look at every single day. It's a non-negotiable element of what we do, and it's the core to the products that we deliver to market. Our implant manufacture is complex, and we have over 131 steps to actually just make a single implant. Okay? 12 tests, 41 inspections, and then there's 16 destructive tests that we also do, where we take product off the line, sampled, and do another test to make sure that we're meeting our manufacturing quality plan. Our operators, our team members, our engineers, our researchers, they have deep and extensive process knowledge. We perform these steps in much higher volume than any, and for much longer than any other company in the market.

And our manufacturing process, the actual technique, the things we do to make a cochlear implant and then do the speech processor, is really key, and it's one of our core strategic advantages in bringing our products to market. From a capacity perspective, we continue to invest in our capacity to make sure that we're, we've got the facilities and the capacity to meet our growth expectations. And we continue to look at our network and manage our global network so that we can meet demand and manage those supply chain risks. Just around suppliers, as I said, we have very, very deep third-party supplier relationships. We have some 565 suppliers located around the world, and you can see the breakup there, relatively evenly split around the globe.

We segment our suppliers based on the amount of customization and the impact on product quality. As you can see, some of the key categories of things that we do buy. We often have very, very long-standing relationships with our suppliers. When we choose a supplier, we really want to make sure that they are ready to join the journey for us, because we're a growth business, and having to chop and change suppliers not only presents risks, it presents regulatory issues, and mostly it affects quality. We really look for suppliers that we can have a very, very long and deep relationship with. When we think about quality and reliability, we think about that with our suppliers as well.

We have to ensure that they've got financial stability, so that they've got the price they're charging us that covers the quality of the products that they deliver to us. Of course, we look at the ethical elements of our suppliers, making sure that they're complying with their modern slavery requirements. The environmental factors are also increasing, so we want to make sure that our focus is on our environmental footprint, and we take mitigating actions to make sure that we are helping our environmental goals be achieved. We have quite a detailed supplier audit program. We visit our suppliers a lot.

We work with them to make sure that they are set up to meet our needs, and we're adding things into those audit programs now, like a check for modern slavery, like a check for other sort of environmental or compliance issues, so that we can make sure that they're complying with us. Probably the last thing I should just touch on is inventory. As I said earlier, inventory, we use inventory to reduce supplier risks. Our product is quite unique in as much as our product life cycle is often longer than many of the components that sit within the product. And so at times, we have to actually do lifetime buys of components or materials that go within our product, because that's gonna go...

Extend beyond the time in which we're going to keep that product in the market. And that's one of the drivers of our inventory, is that we do have a lot of lifetime buys, and those lifetime buys can extend for many, many, many years. We do use inventory to buffer our supplier risk, and we have a number of single-source suppliers. We've worked hard over the years to strategically look at where we can dual source to manage risk, but often it's lower cost to actually hold inventory than to try and add and manage and have another supplier approved. And finally, we think of it like this, that you know, the cost of a sale is generally much more than the cost of holding extra inventory.

Again, we're not foolish with our inventory holding, we're not silly about it, but we do use that to protect ourselves, both against supplier risk, but also to manage our ability to keep product in the market, keep our supply continuity high, and keep our customer experience really good. Perhaps just to finish what we do, and we often do this, and the best way to finish, I think, the morning session is to connect this back to our customers. So you can see in the middle of this photo, a family came across from Canada. We have people from all over the world.

We have an open invitation to any customer who would like to come onto our site, and have a look around, have a look at our manufacturing facility, but more importantly, get to meet some of our production team. So the other people you see in that photo are actually the people that made that young girl's implant. And if you actually want to see something extremely powerful, it's connecting a customer to the person that made the device that's in their head. And that gives the customer a great thrill, but it also gives me a chance, when I'm talking to our production team members, to enable my team members to connect to the customer. So when we say quality is not negotiable, this is the reason why.

Because what we do every day is going to a customer, and we want that product to be safe, effective, and give the outcome that they want. Thank you. I think I have a minute for questions, or we can tag them into Dig's one, if you like.

Dig Howitt
CEO & President, Cochlear Limited

Yeah, can jump on it. Any questions to Greg or to, on anything that we've heard this morning?

David Low
Research Analyst, JPMorgan Chase & Co

Thank you. David Low from J.P. Morgan. Just on the inventory, I mean, we've seen the inventory levels go up, and I think we've all seen the supply chain challenges during the pandemic. But how would you characterize the current position? I mean, when I hear you talk about it, using it as a buffer, it seems to imply that inventory levels might continue to grow from here.

Dig Howitt
CEO & President, Cochlear Limited

I mean, I think it's if I could start on this one, they have certainly gone up. And through the last three years, we haven't had a supply problem that's had a significant impact on customers, where many, many other companies and industries have. So it was the right thing to do, by Greg and his team, to build the inventory up. I think, look, I don't think it's gonna keep rising at the rate it has done. Probably should start to come off, but that does depend very much on what we see back in our supply base. You know, we respond to changes. We try to respond ahead of time, if we can predict things coming. So shouldn't grow at the rate it has.

Should moderate from here, but it does depend on sort of more global situation.

Speaker 13

I'm impressed by the number of suppliers and the geographic diversity, and therefore, my question relates to logistics. You have parts that are made in one part of the world, that have to be assembled in another part of the world and delivered to multiple locations. This has to be a challenge, particularly as the number of products that you're selling every year is increasing. That's great, 'cause that's income. But the logistics principally are a cost, and that has to be controlled. So I suspect Greg's got to be one of the busiest guys in the place.

Dig Howitt
CEO & President, Cochlear Limited

I hope so. Look, our parts are very small, so that works.

Still have to be delivered.

Still have to be delivered, yep. So it is a complex network, and the components we want are very specialized. They're very high quality. So as Greg said, we are rigorous in the selection of our suppliers, and we will look all over the world for the best suppliers, and that gives us a network like we've got. Our job to manage it. Yeah.

Greg Bodkin
SVP, Global Supply Chain, Cochlear Limited

Yeah, what I would say is, we're getting to a size and scale now as well, where we can negotiate much better deals with core logistics providers. And we've done that recently, so we've just signed some 2, 2 global deals with 2 of the core logistics providers. But we're also looking at how we start to move product around the world. So as our network evolves, we're starting to look at how can we position things more smartly? Because a lot of what we buy, we actually don't do any value add to. We buy it, comes in packaged, it's ready to go and ship. And so we're starting to look at how we reposition, relocate, and move those sorts of items around the world. So, yeah, we're very conscious of the cost.

Yeah, part of my job is to make sure that we keep that cost under control.

Craig Wong-Pan
Director, Senior Equity Analyst, RBC Capital Markets

Hi. Just had a question for, for Dean. Wondering what kind of geographies he's most positive on getting some change in reimbursement?

Dig Howitt
CEO & President, Cochlear Limited

Well, you're... Oh, you've got to taken your microphone off. Perhaps you can-

Dean Phizacklea
SVP of Global Strategic Marketing, Cochlear Limited

Front shot.

Dig Howitt
CEO & President, Cochlear Limited

Yeah.

Dean Phizacklea
SVP of Global Strategic Marketing, Cochlear Limited

We say-

Dig Howitt
CEO & President, Cochlear Limited

Here, here one comes, Dean, just for people online. You will notice in the presentation and in your report, we have examples of reimbursement changes over last year.

Dean Phizacklea
SVP of Global Strategic Marketing, Cochlear Limited

Yes, I think, I won't duplicate Lisa's piece, 'cause I think there's some really good opportunities that we've seen already happen, particularly on single-sided deafness . There's an initiative going in parts of Western Europe, 'cause there are a number of other countries that have that opportunity. As you know, that's a rigorous process, but that's an important one. An area that we are focusing on reimbursement is the shift towards telehealth or digital health, and so that got an acceleration during the course of COVID. And many of the reimbursement systems don't necessarily stay current with that, and so there's good work being done.

We've got examples in Belgium, where we've secured reimbursement for elements of our telehealth space, and again, a number of countries that are actively looking for that opportunity. And then there's always the individual countries. Almost every country is focusing on some level of moving, you know, from 80- 70 or 70- 60, or an age gap. So I guess there's a constant focus on continually tweaking the piece, but it's probably the digital health space and single-sided deafness is probably two key areas that are being focused on.

Dig Howitt
CEO & President, Cochlear Limited

Thanks, Dean. Okay, I think we're finished on questions. So thank you all for coming along. We do have some manufacturing tours for people here, and lunch, and the executives team will be staying around for lunch. And the tours we are doing in two groups. So people with the red dot on their name tag going out first, and then whatever color the other dot is, shall we go and get out?

Powered by