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Hi, my name is Brad O'Connor, I'm the CEO of Cogstate. Thanks for your time today. During today's presentation, I'll take you through our results for the first half of financial year '21 as well as our outlook into the second half of '21 and beyond. We'll then have time at the conclusion of the presentation to take your questions. I want to remind everyone that Cogstate reports in U.S. dollars, and all figures quoted today are U.S. dollars. [Operator Instructions]This presentation includes forward-looking statements, and I note our disclaimer. I'm going to start today by outlining the investment case for Cogstate. Firstly, Cogstate has a record revenue pipeline of almost $75 million at December 31, 2020, and a stable cost base that will deliver earnings leverage. Momentum continues to build in our Clinical Trials segment, with continuing good level of sales contracts and the resulting revenue backlog in that segment has increased to almost $50 million. In addition, in the Healthcare segment, the newly executed global license agreement with Eisai will produce minimum royalties of $10 million over the next 5 years. This is in addition to the $15 million royalty that has already been received from Eisai. Further minimum royalties of another $20 million will roll off over the years 6 to 10 of that license agreement. A stable cost base will see margins expand as revenues increase in coming periods. Secondly, Cogstate has significant leverage to an Alzheimer's treatment. There are a number of potential treatments with a short-term path to potential regulatory approval and subsequent product launch. Our recently announced partnership with global pharmaceutical company, Eisai, means that Cogstate is uniquely placed to provide highly scalable digital tools for early identification of patients suffering from cognitive impairment that may be associated with early Alzheimer's disease. Thirdly, Cogstate has unique technology focused on large addressable markets. Cogstate technology has over 20 years of scientific validation, and those digital solutions are perfect for large global markets where there is a growing demand for telehealth and mHealth-style assessments. COVID has forced substantial changes to the healthcare systems globally. The rise of telehealth and mHealth-style assessments has been substantial, and we believe these are permanent changes. The Cogstate technology solutions are well-designed for a virtual -- for this virtual assessment paradigm. Finally, possibly for the first time in our history, Cogstate's business plans are underpinned by a strong balance sheet. During today's presentation, we will explore each of these themes in more detail. Since first launching our technology in the clinical trials market in 2004, the majority of Cogstate revenue has come from this business segment, where our customers are pharmaceutical companies seeking to determine the impact that their investigational compounds have on cognition. Clinical Trials is our established business, and that generated $21 million of revenue in the previous financial year. This is a project revenue model that provides us with great forward visibility and predictability of our revenue. The length of Clinical Trials provides a revenue tail to build from year-to-year. Healthcare, the use of our technology to measure brain health in the community is our next horizon. It was the basis of our original investment proposition and is starting to become a reality as we get closer the release of a disease-modifying therapy for Alzheimer's disease. This is a subscription-based software revenue model sold through our strategic partner, Eisai, who have other revenue, in this case, revenue from therapeutics tied to the adoption of Cogstate software. In both of these segments, Cogstate relies on data. And more than 600 peer-reviewed publications that come from decades of collaboration between academic researchers and the Cogstate scientific team. Our vision at Cogstate is to replace manual burdensome and difficult assessments of cognition with scalable digital solutions that can be formed routinely. Cogstate solutions are perfectly suited to a world adopting telehealth and mHealth solutions. In the wake of the COVID-19 pandemic, we've seen a substantial shift to the way individuals access healthcare. As I said before, we think this is a permanent change, and we're positioned well to leverage from that change. There are 3 key messages for today's presentation. We have executed a landmark license agreement with international pharma company, Eisai, that provides Cogstate with $45 million of minimum royalties over the 10-year license. And that opportunity -- I'm sorry, and the opportunity of significant upside from the potential near-term launch of the first Alzheimer's therapeutic. The size of that addressable market in 4 key markets alone is more than 320 million people. Our Clinical Trials business continues to strengthen. Sales have been excellent in the context of the pandemic. Our revenue in this segment was a little sluggish through the first half of fiscal '21, but still is up 52% compared to the prior corresponding period. Contracted future revenue that will roll off over time is now close to $50 million, which is an all-time high for Cogstate. Cogstate is well positioned to show profit growth in the coming periods. Forecast revenue growth in both the Clinical Trials and the Healthcare segments, supported by a record revenue backlog, provides confidence of revenue growth. Within the context of that revenue growth, cost control provides confidence of profit growth. In October of last year, Cogstate announced an expanded partnership with Eisai that takes us an important step closer to realizing our vision of cognitive assessment performed routinely as part of periodic health assessments. Eisai are a global pharmaceutical company. They have pioneered the treatment of Alzheimer's disease with the launch of the widely used Alzheimer's symptomatic treatment Aricept in 1997. They are global leaders in Alzheimer's disease with a focus on the development of a dementia ecosystem that extends from identification of disease to intervention. Eisai have partnered with Cogstate because our scientifically validated digital assessments are really well suited to use as a screening tool in multiple settings, including home-based self assessment, assessment at the offices of a primary care physician, assessment by specialists or monitoring their response to an Alzheimer's therapy. Presently, the commercial opportunity is focused on the increased awareness of the importance of brain health. There is a market for better and easier assessment of brain health today, with a focus on lifestyle changes that have been shown to improve cognition. The potential future opportunity that's really exciting relates to the potential launch of a disease-modifying therapy for Alzheimer's disease. In that situation, the commercial opportunity centers around the identification of patients who would benefit from such treatment and the ongoing monitoring of those patients, post prescriptions. And the release of a disease-modifying therapy for Alzheimer's disease will require early detection of cognitive decline in order to intervene the slow progression of this terrible disease. The global market for a digital screening tool, that is both scalable and sensitive to change associated to Alzheimer's disease, is really large. To get a sense of how large that addressable market is, in the 4 key markets identified under our agreement with Eisai, being the U.S., China, EU and Japan, we've looked at a number of -- we've looked at the number of people in those countries over the age of 65. Taking those numbers alone, that represents an addressable market over 320 million people, with the potential of multiple assessments each year for some of those individuals. And we've never been closer to the potential launch of an Alzheimer's therapeutic. Eisai, along with their development partner, Biogen, have submitted application for approval to the regulators in the U.S., the EU and Japan. A decision in respect of the U.S.A. approval is expected from the FDA by the 7th of June of this year. Other potential therapies from Eisai and Biogen, Roche, Genentech and Eli Lilly, are all in development with promising data released from prior studies. I'll look now at the specifics of the agreement with Eisai. In October, we executed a global agreement with Eisai, which expands upon the agreement entered into by the 2 parties in respect of Japan. Since execution of that Japanese license, Eisai have proven to be a really supportive partner that's committed to building an entire ecosystem for dementia patients and their families, with solutions targeting everything from identification of the first signs of memory loss, to the development of therapeutic treatments as well as a range of lifestyle factors in between. Under the terms of the license, Eisai will be responsible for marketing Cogstate technology in all countries, including all existing technology and future improvements to Cogstate technology. The agreement will exclude our clinical trials market where Cogstate continues to offer our technology and services independently. The global license has a term of 10 years on a country-by-country basis from the date of the commercial launch in each country. Eisai have committed to launch within the U.S. inside the first year of the agreement, the EU within 3 years and China within 4 years. Eisai do have the option to terminate the global agreement after 5 years under certain specific conditions. Under the license Eisai will pay Cogstate minimum payments totaling $45 million across 10 years, including a $15 million upfront license fee, which we received in December, and then a further $30 million of minimum royalties. The minimum royalties, which increased from year-to-year, total at least $10 million for the period from years 1 to 5 and then $20 million for the period of year 6 to 10. Similar to the agreement in respect of Japan, Eisai will fund any software development work required to further develop, improve or alter Cogstate technology for use within each country. Eisai will also manage all regulatory issues and will be responsible for all sales and marketing activities. The resulting data from the use of the technology will be jointly owned by Eisai and Cogstate. I want to spend a few minutes now to talk about the treatment of the revenue under the Eisai agreement. I'll focus on the most recent global agreement, which excludes Japan, which is obviously the larger agreement. The revenue under the global agreement can be broken into 3 segments: the upfront royalty of $15 million that was received by Cogstate in December 2020; the minimum royalties of at least $10 million payable over the first 5 commercial years of the agreement; and then the middle royalties of $20 million, which is payable over commercial years 6 to 10. The upfront royalty of $15 million plus a minimum royalty over years 1 to 5 of $10 million, so it's $25 million in total, will be amortized over the first 5 commercial years of the agreement. Commercial year one will begin upon the first sale, and that contractually must occur within the first year after contract execution. Therefore, the amortization period has been set at 6 years from contract execution. For Cogstate this equation of minimum revenues under the global agreement of $4.16 million to a financial year. On a pro rata basis, the minimum license fee revenue from the global agreement will be $2.84 million in fiscal '21. The minimum royalties for years 6 to 10 have been ignored at this stage because of Eisai's right to terminate the agreement at the end of commercial year 5. Should that termination right be voided by other commercial events, then the additional $20 million of revenue will need to be accounted. It's important to note that the accounting treatment of revenue recognition will differ from cash receipts. The cash procedure of the $15 million upfront royalty occurred in December, as I mentioned before, whereas the revenue recognized in the first half of fiscal '21 was only $780,000, and that was calculated from the period of execution of the contract on the 26th of October through to 31st of December. It's also important to note that due to the significance of the global license agreement, the group has reviewed the application of this accounting policy in respect of revenue relating to the grant of licenses, provision of supporting services, the provision of server access in accordance with the requirements of the accounting standard AASB 15, which deals with revenue from contracts with customers. And that's resulted in a change to the application of our previous policy. In the prior period, Cogstate recognized all of the $1 million upfront payment received from Eisai as revenue upon granting the license for the Japan region. Cogstate considers that recognizing upfront payment as revenue on a straight-line basis over the license period better reflects its performance in providing access to the license, continuing support of the service -- services and continued access to service. As required by the accounting standard, this change has been applied retrospectively. And as a result, we've restated the comparative revenue figures. The restatement of the prior period is detailed in the appendices to this presentation, which has been lodged with the ASX today, as well as in the financial results, which were also lodged with the ASX today. Switching gears to look at the Clinical Trials segment, where we note the core business is strengthening. The first half sales result was strong and followed a very successful sales period for financial year '20. Those sales have delivered a revenue backlog of almost $50 million as of 31st of December, 2020, which provides great confidence in respective revenue growth in coming periods. As a reaction to the COVID pandemic, Cogstate has established innovative partnerships with multiple pharma companies to utilize Cogstate digital assessment for remote assessment in clinical trials. We see this as a permanent shift in the industry and one that Cogstate can benefit from. Cogstate continues to pursue channel partnerships as a way of increasing market share. The agreement with ERT has delivered multiple sales opportunities, and we are aiming to finalize the first of -- the first joint contract with ERT in the coming weeks. Over the last 18 months, Cogstate has broadened our reach into clinical trials across a range of indications. There is momentum in Alzheimer's disease R&D presently on the back of recent positive data such as Eli Lilly's announcement in respect of their TRAILBLAZER study, for which Cogstate managed all cognitive endpoints. But beyond that, Cogstate is supporting trials and growing business across a range of indications. We need to be conscious of the potential for disruption caused by COVID. The fall in case numbers and an increasing rate of vaccination in the Northern Hemisphere gives us hope that the second half of financial year '21 will see -- will not see the revenue interruptions that we saw in the first half of the year. I'll turn now to the financial results. Overall, we saw a strong revenue growth compared to the prior corresponding period in Clinical Trials. We note that the prior -- prior corresponding period in the Healthcare segment has been restated, as I mentioned earlier. EBITDA for the period was a profit of $700,000, which is an improvement of $3.6 million on pcp. I'll also note that the loss before tax of $360,000 is inclusive of one-off costs of around $0.5 million that were related to the execution of the Eisai global agreement. Importantly, I note that operating cash inflow during the half year was $13.2 million, boosted by the upfront license fee received from Eisai. When we drill into the Clinical Trials segment, we see that the first half '21 result was almost identical to the second half of fiscal '20 results. The cost control from period-to-period is good. As I've noted already, we would have expected to see revenue growth from the second half of '20 into the first half of '21. But some COVID-related delays led to revenue deferral in the first half of '21. All things being equal, we expect to catch-up that revenue in future periods. You can see from this slide that the level of sales contracts executed was good throughout the first half of '21. And in saying that the sales result for the second quarter, the December quarter showed really good recovery from a slightly sluggish first quarter, sales prospects for the March quarter also look good at this stage. For 6 consecutive quarters now, the value of contracts executed has exceeded revenue recognized, which has had the effect of ballooning the Clinical Trials revenue backlog to almost $50 million. Turning our attention to the breakdown of the Healthcare segment, I note again the restatement of the revenue in the prior corresponding period. Revenue in the first half of fiscal '21 increased slightly from the second half of fiscal '20, with the first $800,000 of revenue from the Eisai global license agreement hitting the P&L during the half just completed. We'll see further revenue increases from that global license agreement into the second half of fiscal '21. I note the direct costs increased slightly in the first half '21, but note that some of that cost related to consultancy work undertaken ahead of and in preparation for the Eisai global agreement, those consultancy costs won't be replicated in the second half of the financial year. Cogstate contracted future revenue provides really good insight into revenue growth in the coming periods. At 31st of December, 2020, Cogstate had almost $75 million of contracted revenue that will roll off in future periods. That's an increase of 96% compared to that figure at the same time last year. Of the $75 million, $12.2 million expect to be recognized in the second half of financial year '21. Probably just as importantly, 6 months out from the beginning of financial year '22, Cogstate has already secured over $20 million of revenue for that period. This provides great confidence of continued revenue growth into fiscal '22. To summarize our financial outlook. The Clinical Trials business is really well positioned to show revenue growth in the second half of this financial year. We begin the second half with over $10 million of contracted revenue expected to roll off in this half. Sales expectations for the June half year are supported by Cogstate remote assessment capabilities, our sales, channel partnerships and our strategic customer relationships in a number of important indications. And finally, we're cautiously optimistic that the site-based activity, particularly in the Northern Hemisphere, will be less impacted by the ongoing COVID pandemic during the second half of fiscal '21, and therefore, we'll start to see an increase in the runoff of revenue from that contracted revenue base. In the Healthcare segment, we're already seeing a substantial commercial activity in Japan, and prelaunch activities are being undertaken by Eisai in respect to the U.S. and Asian markets. In the second half of '21, Healthcare revenue will increase with a 6-month contribution from the global license agreement. Overall, we're targeting a profit before tax for this financial year, with only the potential COVID interruptions tempering those expectations while providing some degree of uncertainty as they are for all businesses. So in conclusion, Cogstate has a record revenue pipeline of almost $75 million at the 31st of December, with a stable cost base that will deliver earnings leverage. We remain excited about the prospect of the potential approval as an Alzheimer's therapeutic, to which Cogstate has significant leverage. Cogstate has unique technology focused on a large addressable market, where our digital solutions can leverage the growing demand for telehealth and mHealth-style assessments. Finally, possibly for the first time in our history, Cogstate business plan are underpinned by a strong balance sheet. I want to thank you for your time. And with that, I'm happy to take your questions. [Operator Instructions]
Fantastic. Thank you so much, Brad. We do have several questions coming in, and I again also encourage other questions. To get started, though, first question is, is the one-off $0.5 million adviser expense related to the Eisai global deal included in the group overhead of $6 million?
Yes, it is. And that's obviously a one-off, nonrepeatable cost, but it's included in our overhead costs.
Great. Next question. What are the priorities for the use of surplus cash? And to the extent that, that includes M&A, in what area would that be focused?
So look, that's a good question. Our priorities are really focused around technology improvement that will leverage the changes to telehealth and mHealth-style assessments. And I should clarify. When I say mHealth, I'm talking about the use of self-assessments, mobile-device-type health assessments. The critical aspect in respect of that is going to be the ease of use of those technologies. So we need technologies that are easy to access, they're intuitive to use, they don't rely on any special equipment. So we're talking largely phone-based assessments and phone-based hardware being the most available hardware source for most individuals. So one of the key areas where we will be focusing over the coming period is the development and release of very intuitive mobile assessments. That work is already underway. And a lot of that work is already being funded externally to Cogstate, so being funded by Eisai. And you'll recall that also we were in receipt of a grant from the Alzheimer's Drug Development Foundation as part of their digital biomarker strategy, which is backed by the Gates Foundation. So that was a $1.3 million grant. So we have funding available in respect of that, but that will be a key area where we'll be looking to focus. In terms of M&A activity, which was the second part of that question, we'll continue to look at potential opportunities, both in the Clinical Trials segment and the Healthcare segment to the extent that such opportunities make sense within our strategic plans.
Perfect. Thanks so much for those perspectives, Brad. Another question. Is there any risk on the forgiveness on the U.S. PPP loan with a very strong balance sheet and the $2 million annual royalty yet to come with the Eisai global deal, would the company consider any capital management activities such as shares buyback?
So we're not, at present, considering any capital management activities. In respect to the Paycheck Protection Program loan, which is a $2.4 million loan under the U.S. government's coronavirus aid package, our position at this stage is that we've utilized that funding for the intended purpose. So that funding was separately quarantined within our bank accounts and was used solely for the purpose of U.S.-based employees' salary and wages. And we have noted, of course, during this presentation that we have seen slowing of revenues through the first half of fiscal '21. So from my point of view, we've used the funds as intended. And our business has been impacted by the coronavirus pandemic. I won't comment further in respect of the application for forgiveness, other than to say that we're going through that process currently.
Perfect. And then another question. Is the financial year '26 to '30 revenue backlog related to the Eisai partnership, or is it Clinical Trials?
Largely speaking, that's Clinical Trials, but I'm just going to bring up the slide. When we have a look at -- we have a look at this slide here, just to refresh everyone's memory. The -- as you can see, the Eisai partnerships represent a portion of that but $50 million of the $75 million is Clinical-Trials-related backlog. Most of the backlog runoff for '26 to '30 relates to the Clinical Trials business, remembering, of course, that we haven't taken into backlog the minimum royalties under the Eisai agreement for commercial years 6 to 10, which is a further $20 million.
Great. And then going back to the -- related to the Eisai partnership, but also a little bit different. I'm going to combine a couple of questions here. In the event that an Alzheimer's drug does get approved, how likely is it that our tests will be used in the rollout of a drug? And then related to that, will Eisai be as motivated to push out Cogstate tests if another company's drug gets approved first?
Good questions. So the issue will be with the launch of a therapeutic is identification of 2 issues: the first is cognitive decline; and the second one is elevated levels of amyloid in the brain of the patient. Whilst Cogstate technology won't be considered a companion diagnostic in the truest sense, the reality for us is that there is going to be a need to have easy-to-access and scalable solutions to identify the appropriate level of cognitive impairment. Those 2 -- whether that makes addition -- whether that's an Eisai drug or a drug from another company, we see all the time in the pharmaceutical industry that diagnostic assessments that are owned by one company would be used as part of the diagnosis process for a drug sold by a different company. And so the most obvious example there is -- or the most -- example in Alzheimer's disease is the various PET scans that are produced by different companies, the amyloid PET scans, which would be factored into the sales and marketing activities or the diagnosis planning for any company that's planning for the launch of an Alzheimer's disease therapeutic. So essentially, when you're trying to sell the therapeutic, you want the easiest, most cost-effective way of identifying those patients that will benefit from the therapy. So we think we're well placed regardless of what kind of therapy hits the market.
And a little bit of different angle here, still on the Eisai partnership. How is Cognigram Japan's regulatory approval going? And is that delaying Eisai's commercialization?
So the approval process is underway. So Eisai are managing that with the PDMA (sic) [ PMDA ] in Japan. So that process is underway currently. They're in discussions there. The fact that, that's not approved currently isn't preventing them from their activities, which are really focused on consumers at this stage and on awareness of brain health. And so the -- a lot of their activities are focused around the marketing of the NouKNOW technology, which is the Cogstate brief battery that has been designed for a consumer application. So the commercial activities there are ongoing. They're continuing to consult with the regulator in Japan and looking to have regulatory approval for the Cognigram product prior to therapy launch in that country.
Great. Fantastic. And I just want to thank everybody for the great questions that we've had coming in. We will take a few more, and then we'll wrap up. So if you have anything burning, please go ahead and submit it now. So switching gears a little bit, Brad. Could you provide some color about the ERT partnership? What does our pipeline look like? And how is ERT working with us to make sure the partnership is a success?
That's a good question. So look, we're really happy with the partnership with ERT. They've been a proactive and engaged partner. Their commercial and marketing teams have been very engaged with ours and have been driving opportunities to Cogstate. So, so far, we're very happy with their level of engagement in the partnership. As I mentioned, there's a number of joint opportunities that we're pursuing, and we're hopeful of announcing the first win under those shortly. Obviously, we would have preferred to have already secured contracts and would have liked the opportunity to have announced that, but you'll appreciate that the timelines from pitching of these opportunities to securing them can be quite long. So the timelines here aren't unusual in the context of the work that we do and the business we operate in. And as I say, we're really happy with the level of engagement from the ERT team, particularly at a senior level. So I think it's really encouraging. And we do believe that those channel partnerships are a really important factor in how do we grow our sales based on our market penetration for Cogstate.
Great. Thank you. And another question related to ERT. Let me see, just reading this one really quick. Could you give some color on what to expect with joint wins with ERT compared to current Alzheimer's trial mixes. So just like this -- the size, the phase, maybe just a little bit more on the types of deals we're looking on, potentially?
Yes. Look, it's probably too early to answer that question, to be honest. You'll appreciate that we only announced the partnership in the first half of fiscal '21. It takes some time to develop joint marketing materials and to get out there and sell it. So I think it's too early to comment on the mix. What we're seeking to do, of course, is to not only work with ERT in respect to central nervous system diseases, but also really leverage off their market share outside of central nervous system diseases. So we think there's a huge opportunity for use of cognition as a safety endpoint and looking to leverage off, as I said, ERT's market share in a number of those indications. So I think the mix will change, but it's probably too early at this stage to comment on what that's going to look like in the short term.
Great. Thanks for that, Brad. And with that, we're going to go ahead and take this final question, and it's around -- you spoke about our unique technology. And what does Cogstate's technology roadmap look like in the near future? And what are some of our priorities?
Yes. So as I mentioned before, really we'll be focusing our product development around the shift in mobile devices that will include audio as well as visual interactions with patients. We need to improve the user experience and the user interface and make sure that those assessments are intuitive as possible. Focusing around the idea of assessing a 7-year old, unsupervised at home, and if we solve for that problem, we think that solves for a number of problems. And the application of that technology across our different segments, so that same technology into the Clinical Trials segment, we think, has great application. And it's just an improvement on the types of solutions that we have now. So our technology at the moment is good. But we understand that it can get better. And that's where we'll be focusing a lot, it's around the delivery mechanism, to the hardware that's required there, as I said, that push to phone-based or smartphone-based assessments. And utilizing that technology and the ubiquity of that and the availability of that technology will be a key factor in how we develop our technology going forward. And then as always, there's a focus on improved sensitivity of our assessments, and really focusing around -- if we look at that healthcare market, really focusing around identification of patients who will benefit from a therapy. And whilst our databases there are excellent, we do think there's the ability to improve those and to improve the analysis, to provide increased sensitivity over time. And as we build up that normative database through the use of that technology, we expect that, that -- the sensitivity and specificity of those assessments continue to improve.
This is great, Brad, exciting opportunities. And that concludes our question segment.
So thank you, everybody. I want to thank you for your interest in Cogstate. I'll point you again to the ASX website, where this presentation has been lodged with a number of appendices that provide additional detail. And as always, thank you for your interest in Cogstate.