Good morning, ladies and gentlemen, and welcome to the Akili Inc. Market Update Call. This call is being recorded on Thursday, September 14, 2023. I would now like to turn the conference over to Julie DiCarlo at Akili. Julie, please go ahead. Hello, and thank you for joining our call this morning. I'm joined on today's call by Akili's CEO, Eddie Martucci, Matt Franklin, our President and Chief Operating Officer, and Santosh Shanbhag, our Chief Financial Officer. We issued a press release yesterday morning with an update on the business. You can access the release on the Investor Relations section of our website, along with slides that we'll reference during today's call. This call is being recorded, and we'll make a replay available on our website shortly after today's event. During today's call, we'll make forward-looking statements regarding future events, expectations, plans, prospects, or the financial performance of the company. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by the company's management, involve certain risks and uncertainties. The company's actual results may differ materially from those expressed or implied by any such forward-looking statements as a result of various important factors. Factors that might cause such differences include, but are not limited to, those risks and uncertainties set forth in our previously filed Q2 2023 Form 10-Q, as well as other subsequent filings with the SEC. Information provided on today's call reflects our views only as of today, September fourteenth, and should not be relied upon as representative of our views as of any subsequent date. We explicitly disclaim any obligation to update or revise any forward-looking statements or our outlook. Also, during today's call, we'll refer to certain non-GAAP financial measures. Management does not intend the presentation of those non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP, but as a complement to provide greater transparency. A reconciliation of the historic non-GAAP financial measures to our GAAP financial measures is included in our slide deck accompanying this call and in yesterday's press release. If you're following along with the slides, please turn now to Slide 4 as I hand the call over to Eddie for his prepared remarks. Eddie? Thanks, Julie. Good morning, everyone, and thanks for joining us. I'm excited to share with you all today a major evolution of Akili's business. We announced yesterday a pivot in our business so that we can access a much larger market than we've been in for most of the last year, and to remove the key friction points between patient demand for our product and our ability to satisfy that demand. A few months ago, we began to test a new approach, releasing our initial adult product under the public health emergency in a model that maintains the medical nature of the product, but does not require a prescription. On our earnings call five weeks ago, we shared that the early data were promising enough that we decided to pursue a regulatory path for the adult product as an over-the-counter, FDA-authorized product. We now have a full three months of data from the release of EndeavorOTC, and we believe the data are so compelling and clear that we're going all in on this non-prescription, clinically validated model. We announced yesterday our plan to shift our business from a prescription model to a non-prescription model for all patients with ADHD. In a few minutes, the team will walk you through these detailed data, which show why we believe this business pivot allows us to reach more people much faster. This is a big change. We've been running a prescription model that has dependencies on healthcare stakeholders, who we don't solve a direct problem for. Friction here was honestly more than we anticipated. Insurers have been extremely slow-moving and are not stepping up for innovative medical products, even when they're safe. Additionally, physicians are steadily adopting our product, but in today's world, many patients are unable to navigate or are frustrated with the typical prescription process when a product is abundantly safe. The result is that the business is growing, but more slowly than our potential, given the need we know we can solve in the market. Instead, this new model directly empowers patients to get access to our safe and clinically validated products directly, and we're seeing how powerful that is in our early data. We're beginning in the adult market, where 11 million people are impacted by ADHD in the U.S. alone. As of today, we're shifting our spend dramatically toward our adult market and EndeavorOTC growth as a non-prescription product while we pursue an FDA OTC label. We will be keeping EndeavorRx on the market for pediatric patients, but in a slower burn mode, and we intend to work with FDA to transition it to a non-prescription product over time. What's really exciting is that this business pivot leverages everything we've spent the last 12 years building, and it matters to consumers. This is not just another health app. This product is showing up to consumers as a sophisticated, powerful, next-generation medical product with 10 years of published clinical trials and offering consumers the same technology as the world's only FDA-approved prescription video game, but now without a prescription. Just as important, we believe this model will allow us to deliver our products much more economically. Accordingly, we've restructured the business to be more lean and to allocate capital to our new consumer-led model and remove large cost centers of the business that were built specifically to serve a prescription product, allowing us to more aggressively grow our top line while also extending our runway. With this transformation of our business, we're taking destiny into our own hands, and the power of our products themselves are poised to be the driver of our success. I'll now turn it over to Matt, who will walk you through the data underlying our new business direction and how we're setting the foundation for the new Akili. Matt? Thanks, Eddie. As Eddie highlighted, our strategy has always been clear: develop technology that directly improves cognitive function, then validate these therapies with rigorous clinical studies, giving us a durable competitive advantage. That strategy hasn't changed. What has changed is how we deliver these life-changing treatments to our end users. In June, we released EndeavorOTC to answer a few questions: Would adults with ADHD respond favorably to this product without a doctor's prescription? And will we see engagement and retention rates that could support a new subscription-based business model? In the last three months, we've learned the answer to these questions is a resounding yes. The result has been a change in the course of our business. We are now on a new growth trajectory spurred by our non-prescription model. As you can see on Slide five, the demand is clearly there. Over 125,000 individuals have downloaded EndeavorOTC, meaning that in just 90 days, we've had direct engagement with a group that is equivalent of more than 1% of the 11 million adults in the U.S. who suffer from ADHD. Greater than 15,000 of those individuals have signed up for a free trial, and 4,100 have paid for subscriptions at an average of over $80 per user, generating more than $340,000 in billing. This is a scale that is significantly greater in volume and revenue than our total business for the first two quarters combined, when our business was primarily a prescription model. With moderate initial investment in marketing, this is also done at a fraction of the spend per customer compared to the prescription model. The acquisition economics are encouraging. Turning to Slide 6, we also like what we've seen with engagement and retention, particularly given the fact that we took a product built for a pediatric audience and made it available to adults. Of all the subscriber sessions that were played, about 57% were played for at the full 25 minutes of recommended therapy time, a strong sign of commitment. We've also seen month one and month two renewal rates at 51% and 67% respectively, in line with other consumer health and wellness apps, but at a premium price three-four times higher than industry average, reflecting what we believe is a willingness to pay for the clinical impact of our product and the rigor of our supporting data. In short, we know this model works. There's strong demand and engagement, and we have the ability to continually evolve our product to improve on that baseline. For example, if you turn to Slide 7, we recently released an update that includes our proprietary focus score, which measures how quickly and accurately patients can complete a task despite distractions during treatment, setting benchmarks and quantifying progress towards clinically meaningful improvements in ADHD-related symptoms and quality of life. A patient's personalized baseline focus score is calculated during treatment onboarding, along with a target that serves as a motivational treatment goal to drive ongoing engagement. This is what makes us unique and different. Our value comes not just from the engaging content we provide, but in the real improvements we make in the lives of our users. Finally, by eliminating the prescription requirement and the associated fulfillment costs, we believe we're at a much stronger cost basis, and we believe we'll be able to take full advantage of our ability to continually evolve our offering to realize product margins of 60%-70% by late 2025. So what does this mean for us going forward? If you turn to Slide 8, you'll see our priorities. We are now laser-focused on customer acquisition and retention. Removing our field sales and market access teams and cutting G&A expenses will free up capital to deploy towards dialing in our direct digital marketing efforts, while in parallel, developing other sources of organic acquisition, including potential partnerships and business-to-business channels. We're also listening to our users and releasing frequent product updates to keep engagement high and individuals continuing to use EndeavorOTC over time. We'll continue to tailor the game to adult users, and we believe updating the gameplay to appeal to adult users will have positive impacts on engagement and retention. In the pediatric market, we've seen how the dependency on gatekeepers has limited our growth. It is our intention to transition EndeavorRx to an over-the-counter product, as well to eliminate these barriers for parents and children. We will continue to work with FDA on our in-process indication expansion submission for the 13- 17 year-olds, and then plan to submit a 510(k) application to FDA in 2024 to convert the full 8- 17 year-old EndeavorRx population from a prescription-only product to an over-the-counter offering. During this transition period, we plan to continue to support the patients who are currently using EndeavorRx, as well as process new orders from providers. We are also on track to submit EndeavorOTC for adults through the 510(k) pathway later this year, which, if successful, would be the first OTC label designation for a digital treatment. While we continue to optimize the non-prescription model, we believe we now have a more streamlined path to expanding our addressable market. Today, we're serving the ADHD population in the U.S., but it's important to remember that the technology that powers our products has been studied in clinical trials with conditions such as major depressive disorder, mild cognitive impairment, multiple sclerosis, autism spectrum disorder, lupus, and others. Conditions that impact a significant number of individuals in the U.S. Across all of these studies, we've seen consistent and similar improvement in attention, function, and symptom relief. We've always had the vision of expanding to these markets in the future, and now we believe the non-prescription model will enable us to expand into these markets in the future without having to add specialty sales and commercial support teams, something we couldn't do with a prescription-only product. To wrap up, we're making this business transformation with confidence. Confidence that the adult market opportunity is real, confidence that removing intermediaries gives us control over our growth, and confidence that we can drive engagement to create a streamlined, profitable, subscription-based business. In short, we're able to bring our proprietary approach to more people faster than we were able to before and with much more efficient model. I'll now turn it over to Santosh, who will walk you through Slide 9 and the key metrics that you should use to track our progress. Santosh? Thanks, Matt. Hello, everyone. To help you get a clear and transparent view of the business, moving forward, we plan to share with you three critical metrics for EndeavorOTC on a quarterly basis that we believe are the fundamental metrics defining growth of our new model: active subscribers, billings, and average revenue per paying user or ARPU. As you can see on Slide number 9, the first metric, active subscribers, is basically the number of people who have paid for and use EndeavorOTC. It is defined by total active paying users in that period. As Matt indicated earlier, between June sixth and September fifth, we have added 4,170 active subscribers. That's more than 1,000 a month within the first three months of making EndeavorOTC available to adults in the U.S. market. The second metric, billings, a non-GAAP metric, which we believe provides helpful information regarding the economic contribution of the subscribers. For those who dialed into our second quarter earnings call, you may remember we had introduced this metric on that call to give you a better sense of what people actually paid us during that quarter. Please refer to our press release for more information on our revenue recognition policy as well. EndeavorOTC revenues and billings were about $341,000 in the first three months of the product being available in the U.S. market. And the third metric, average revenue per paid user, sometimes referred to as ARPU, is the economic contribution of each user. This is defined by billings divided by the number of users who paid for EndeavorOTC within that period. As Matt mentioned earlier, average revenue per paid user for the first three months of EndeavorOTC being available in the U.S. market was about $82. Keep in mind, this reflects a blend of what our customers pay between monthly and annual subscriptions. Now please turn your attention to Slide 10 on financial guidance. From an operating expense, expense perspective, first, we are reaffirming our 2023 non-GAAP total operating expense guidance of $55 million-$60 million. This includes the savings impact of the restructuring we announced yesterday, offset partially by reallocating some of these funds towards marketing, supporting customer acquisition for EndeavorOTC. Note that the guidance provided excludes stock-based compensation expense, impairment loss on certain assets associated with our sublease, and severance and termination-related costs associated with the workforce reduction. Second, we expect our 2024 non-GAAP total operating expenses to be between $42 million-$47 million, which is lower than the 2023 guidance that I just reiterated. Note that the guidance provided excludes stock-based compensation expenses. From a cash runway and profitability perspective, with the planned business pivot to a non-subscription model and the restructuring we announced yesterday, we now expect our cash runway to extend well into the second half of 2025. And lastly, based on our initial experience in the adult market and the efficiency gains of significantly simplified product distribution, we believe that we will be operating at software-like gross margins of between 60%-70% by late 2025. With that, I'll hand it back to Eddie to wrap up our prepared remarks and then open it up to questions. Eddie? Thanks, Santosh. We're excited, as you can tell. In summary, the actions we've taken enable us to take full advantage of the power of our technology to leverage our differentiated clinical evidence, and now much more efficiently access a large market in need. And we're letting the product platform we've spent 12 years building and validating be the key to success. So at this point, I'll open it up for questions. Thank you, ladies and gentlemen. We will now begin the question and answer session. Should you have a question, please press star followed by the one on your touchtone phone. You will hear a three-tone prompt acknowledging your request, and your questions will be pulled in the order they are received. Should you wish to decline from the polling process, please press star followed by the two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Judah Frommer with Credit Suisse. Please go ahead. Yeah. Hi, guys. Thanks for the detail and the update here. I guess first question is kind of what does this say from your perspective about the prescription DTx market? How much of this is a function of EndeavorRx for peds being, you know, directed at an indication that has somewhat limited health economic impacts from a modeling perspective for payers, as opposed to maybe some other indications that digital therapeutics go after? So yeah, if you can just talk about how specific this decision is to your product versus maybe the broader market. Sure. Thanks for the question, Judah. Good to hear from you. I wouldn't say that every single market is exactly the same. What I would say is that what we're seeing is the friction of a prescription model, and the reticence of insurers to step up to non-drug treatments, is broader than any one market. I don't believe that - and as you know, we're, we have plans in the future to hopefully address many more markets, beyond ADHD. So this is a macro view for us. We think it's better for patients. We don't think it's just related to ADHD patients. That said, our intense and entire focus right now is the ADHD market, and for us, this is unquestionably the right decision in that market. Okay, that makes sense. Yeah. And then I guess just from to help us out, where have you guys landed on a definitive pricing strategy for the adult OTC products, or are you still testing out pricing? Anything you can give us in terms of, you know, I guess, what's worked best and what you anticipate going forward? Hey, Judah, it's Matt. Yeah, this is an area that we are actively experimenting with. Currently, we do offer two options. We have a monthly subscription-based option as well as an annual option. The current pricing is around $25 a month, around $130 for an annual subscription. Of course, these are, these are going to change over time, right? As we continue to experiment and optimize and, and see what works best for us as well as for our, our users. Great. Thank you. Your next question comes from Marie Thibault with BTIG. Please go ahead. Hi. Thank you for taking the questions this morning, and thanks for all the details. Wanted to try to understand, you know, as we, as we make this shift toward the OTC approach, how you think about your serviceable addressable market. Understand certainly there's a very large TAM out there, but as you think about the patients who can pay for this product out of pocket and that you can reach, you know, through DTC efforts, is there a way to sort of size up how many million patients that might be? I think we are still, thanks for the question, Marie, first of all. I think we're still focused on the TAM. Our perspective, and hopefully you heard it in the script, but I can try to elaborate. Our perspective here is that this model is more efficient and directly accessible, and as Matt just mentioned in response to Judah, right now, this is operating at a price point that is lower and more affordable for patients. So, when we step back and look at the entire market, we've never guided on penetration or anything, but those dynamics, in our view, should allow a much broader penetration into the market because it's just much more accessible, both from a model and a pricing perspective. Okay. Yeah, well understood. And then I guess as a follow-up, as you think about this, successful, you know, summer with EndeavorOTC in the adult ADHD market, do you expect any real big differences, as you think about that in the pediatric market, as you move toward OTC there? You know, any changes to sort of, I guess, you know, compliance or pricing or, you know, ability to sort of, reach those patients? Thanks for taking the questions. Can I ask a clarification, Marie? You're asking, related to, like, the timing, like, related to the year timing or just the difference between adult and pediatric? Just the difference between the two populations, if we might see difference in those stats and some of the encouraging, you know, findings from the- Got it ... from the early days in the adults. Thanks. Yeah, this is Matt. I can take a shot at that. You know, I think, you know, when we look at sort of the history with our Rx product, we see, you know, similar sorts of drivers with engagement and, you know, time spent in therapy. So I think a lot of those will be universal across the board. You know, I do think with the pediatric offering, we will continue to include considerations for the caregivers, right? That is probably one of the primary differences. With the adult population, we can go directly, we can engage them directly with the game. Obviously, with the pediatric, we want to make sure that we are engaging that entire team, and the parents and the caregivers are critical. We'll continue to offer ancillary or complementary offerings for the parents as well. Yeah, and I'll say, Marie. I'll just add that in our previous data, you can see that there was a drop-off when insurance doesn't cover, and the price point, you know, is at roughly $99 a month. We've seen that as a pretty sizable drop-off point. We've also seen, and we hear anecdotally very often in our pediatric market, that navigating the prescription process, not the demand for the product, not the doctor's recommendation or suitability, but just navigating that process is also a major friction point. So, I do think, you know, without guiding to specific numbers, I think the same dynamics are at play in that market as well. And so that's why we're, we feel confident that we wanna put plans together for the entirety of the ADHD market here. Yeah, those are good points. Best of luck with it. Thank you. Thanks. Ladies and gentlemen, as a reminder, should you have a question, please press star followed by the one. Your next question comes from Charles Rhyee with TD Cowen. Please go ahead. Yeah, thanks for taking the questions. You know, Eddie, if we think about the other indications that you guys will eventually start working on, is the plan then for everything to go OTC at this point? Maybe talk about other strategies to get to market. You know, if I'm thinking about, for example, MS, is there any thoughts to, you know, partnering with pharma to get on label as an adjunct to therapy? Or, you know, with it being OTC, is there still a path maybe to sell direct to employers that may wanna cover it as a benefit? You know, could you give us some thoughts on, you know, a little bit here on ADHD and maybe an employer strategy, if there still is one, and future products, other partnership opportunities? Sure thing. Thanks for the question, Charles. So Matt mentioned as part of the, as part of his talking point, he briefly mentioned, in ADHD, that our focus is, is consumer ac-- or customer acquisition, and obviously we have direct-to-consumer efforts that are, converting quite well. But as you mentioned, we do think that, B2B options, and we're keeping that broad, right? So call it general channel partnerships are enabled. Frankly, in the market, through our own discussions, we've also seen that the prescription model is an impediment often to B2B and channel partnerships. So, this is something we're gonna be looking at. You know, I think too early for us to really specify a specific model, but I do think that there's a very real potential to complement or supplement or be a driver of this model through channel partnerships. So yes, that's the long answer for yes, the short answer, that this is, it's a supplemental or complementary strategy that we will pursue in the ADHD market as well. With regard to broader markets, yes, at this point in time, we believe for the foreseeable future, that the conditions that we could impact, that all of those make sense to have a directly accessible customer-led model. So, that is why at this point in time, you know, we're not talking about timing of where those future products or programs might be. But we do believe that this is a much more agile and nimble model, if and when we decide to get into those markets for the reason that you don't have to spin up massive, massive investments in capital infrastructure in those markets. And all of those patient populations are also actively looking for, you know, brain health, treatments online. So I do think it makes sense. Now, in the long run, you know, depending on how insurance, reimbursement evolves, depending on how the healthcare landscape evolves, you know, is what we're saying today definitive and the last word for the long run? Of course not, companies have to be nimble and agile. But in the foreseeable future, what we're seeing in the ADHD market, with the ability to grow dramatically and a much better gross margin profile, that's the stake we're putting in the ground today. Charles, this is Santosh here. Just to add on that, I think you had a question there about partnerships with pharma. We are always open to partnerships, to make sure that our products get into the hands of patients as quickly and easily as possible. I would not restrict that just to beyond ADHD in the United States, globally, we would also look to expand in those areas as well. So I just wanted to address that question about partnerships as well. That, that's helpful. Now that you're really pursuing OTC, the sort of designation with FTC, sorry, FDA, are you able to revert back to a prescription model in the future if insurance decides to step forward and say, "You know what? We want to cover this product"? How does that work? Is that still a possibility down the road? Yes. Short answer is we have a prescription label, obviously, for EndeavorRx. If we go through a conversion process as intended, then yes, the ability to, you know, have prescription and OTC, depending on the labeling, yes, that's always enabled. Okay. But at this point, would you still pursue a prescription label for adults, or at this point, there's no intention to pursue one for that? No. Right now, we're gonna lead with our main product plans here. Our main labeling plans are to start as a non-prescription product, and that's really this model. We don't intend to run two businesses, a prescription and a non-prescription business over the next couple of years. So, really, we wanna consolidate and focus, make sure our costs are contained and that we can grow, and that means leading with and primarily running a non-prescription business. Great. Maybe I'll just follow up on Judah's first question, which was, you know, what does it say about the, the PDT market, I guess. In the end, is it just too new, too soon, or is it, you know... 'Cause it would seem like even in pediatrics, right, you know, if first line treatment ends up being stimulant use, you would think that payers would look at potential harm, you know, versus benefit, you know, from drug use. Just wanted to get a better sense on, you know, why that friction has been so hard. Yeah, I've talked before about inertia. I hope, I sincerely hope we get to a point in this world where insurers are immediately doing the right thing for patients because they're safe and effective products, and patients need more options. We have seen with our products, we've seen if you level up to digital therapeutics, we've seen if you level up beyond that to mental health care, that for many different reasons and many different excuses, insurers will refuse to cover or will delay coverage. And so I don't think there's any one answer. I think the incentives aren't necessarily always there, and I think the inertia is real. I do believe and hope that that will change over time. We, as a business, have to be focused on sustainability and profitability in the near term, and that's all I care about at this point in time, and the ability to serve as many of our patients as we can, as quickly as possible. So this is a pretty easy decision. Great. Thank you. Thanks, Charles. There are no further questions at this time. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.
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