Akili, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Akili, Inc. second quarter 2023 earnings conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, August 10th, 2023. I would now like to turn the conference over to Julie DiCarlo, Senior Vice President of Communications. Please go ahead.

Thank you, Chris. Good afternoon and welcome to Achilles Earnings Call for the second quarter of 2023. This is Julie DiCarlo, and I'm joined on today's call by Achilles CEO, Eddie Martucci, our President and Chief Operating Officer, Matt Franklin, and our Chief Financial Officer, Santos Schoenbeck. Also joining us for the Q&A portion of today's call is Achilles Chief Medical Officer, Scott Collins. We issued our earnings release after the market closed today. You can access the release on our investor relations section of our website along with the earnings 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, involves 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 include such differences include, but are not limited to, those risks and uncertainties set forth in our Q2 2023 Form 10-Q that we're filing today, as well as other subsequent filings with the SEC. Information provided on today's call reflects our views only as of today, August 10th, and should not be relied upon as representative of our views at any subsequent date. We explicitly disclaim any obligation to update or revise our forward-looking statements or outlook. Also during today's call, we'll reference certain non-GAAP financial measures. Management does not intend the presentation of these 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 earnings slides and in our earnings release. If you're following along with the slides, please now turn to slide three as I hand the call over to Eddie for his prepared remarks. Eddie?

Thanks, Julie. And hello, everybody. To orient everyone, for those with slides, I'm going to turn to slide four. As the business has evolved since we last spoke, and we're now operating in two markets in the U.S. with two independent products, the pediatric ADHD market with our FDA authorized prescription product, Endeavor Rx, and now the adult ADHD market with our recently released over-the-counter product, Endeavor OTC. For EndeavorRx and the pediatrics business, as you know, we've been live with the sales force for just over three quarters in our current addressable market of just over 2 million children, ages 8 to 12, and we're looking to expand the label to include adolescents with our FDA review that's underway. With EndeavorOTC, we've now entered the adult ADHD market earlier than expected, which is a market five times larger than our current EndeavorRx market at around 11 million patients. This adult market has unique market dynamics, and as we've started to engage directly in the market with a live product, we see enthusiasm for a new treatment focusing on attention issues. In our pediatric ADHD market, we continue to see quarter-over-quarter growth in prescriptions, prescription refills, and prescribers for EndeavorRx. This all tells us that the value of EndeavorRx is resonating with patients and providers, increasingly so every month. That said, revenue was flat. in large part due to insurance continuing to lag and block patient access. We're seeing this insurance barrier play out as the number of patients utilizing our patient assistance program increased substantially in Q2. This is clearly an issue that's broader than our product and market, as I'm sure you've recently seen the White House take the insurance industry to task for not living up to mental health parity. That eventually has to change, but we're pleased to see continued growth in the areas that we can control. Most exciting in the past quarter is our entry into the adult ADHD market. We released Endeavor OTC as an over-the-counter treatment for direct purchase by adults with ADHD. The product went live in the Apple App Store in June under FDA's COVID enforcement discretion policy. It's built on the same tech as our FDA approved product and we decided to release the product while preparing our FDA submission because of our strong clinical data in adults and the documented growing need right now in the adult market. This initial release allowed us to assess consumer demand and inform our regulatory and commercial strategy. We look forward to sharing specific data on Endeavor OTC once we have more time in the market, but what I will share today is that based on what we've seen in the market thus far, we plan to pursue an FDA OTC regulatory path and commercial strategy for the adult market. And during this time, the product will remain on the market as we continue to optimize it. We believe the OTC business model has the potential to efficiently scale to a large market actively seeking treatment with significantly less friction compared to what we see in our prescription model and significantly less reliance on insurers. This move also places us at the forefront of a new societal shift to over-the-counter models for products that are clinically validated and safe. We think we're on the right side of innovation here and are proud to pursue what, if approved, would be the first digital treatment with the FDA authorized OTC designation. At the macro business level, we continue to carefully manage our capital as we operate and grow our business, and we remain able to fund our current and planned operations into Q1 2025, which we believe is important in this current environment. I'll now turn it over to Matt and Santos to take you through the actual data.