Akili, Inc. (NASDAQ:AKLI) Q2 2023 Earnings Call Transcript

Eddie Martucci: Sure. Will take the first part of that. Good question, Lucas, and then I will pass it to Santosh for a bit. So, at a high level, we are not guiding on anything related to contribution in any of the metrics at this point. We are looking, as Matt talked about, to continue to lean into optimizing the model and learning more as it’s on the App Store, right. I think at this point, we have had a limited kind of early set of weeks here on the market. I think there is a lot more we can optimize and continue to learn. And so, we will invest in that. As we have talked about, we are not going to increase our OpEx this year. And so as we look at investing across these various opportunities across the ADHD market, we will juggle those and we will optimize in a way we think best, including some earlier and more optimization in this OTC path.

Santosh Shanbhag: Yes. Thank you, Eddie. Just to add to that, I would say like Eddie said, we are not providing guidance on revenues, as you know. We do expect to see the EndeavorOTC continue to remain live in the market so they will obviously be some contribution of revenues through OTC. From an expense perspective, we are looking at balancing our total expenses and investments in marketing versus what we need to support the Rx business as well. But keep in mind, we are reiterating our total operating expense guidance of $55 million to $60 million for the current year, and we don’t plan to change that at this current point in time.

Unidentified Analyst: Okay. I appreciate that. And then in terms of progress with payers, last call, you guys noted that Kroger’s health plan adopted coverage across their members. Curious to hear where you guys are at with conversations with other payers. Do you guys get the sense that payers are waiting for real-world evidence data. Just kind of curious to hear an update on that.

Eddie Martucci: Sure. Matt?

Matt Franklin: Yes. Hi it’s Matt. Yes. On the insurance front, unfortunately, no new news to report there. And there is no question that this process is taking longer than we want. It’s interesting, Eddie highlighted some of the challenges are not necessarily unique to Akili. We saw the White House released a memo, highlighting some of the disparities in mental healthcare. We continue to engage with the payers. And thanks to answer your question, it’s really kind of unique to each payer. We are working with them through their process. We are continuing to work as aggressively as we can to expand access for our patients and their families.

Eddie Martucci: Yes. I will say very clearly. I think it’s clear from my perspective, from our perspective, this is not about additional data for EndeavorRx. This is not about a specific product. This is about inertia in the system, which is why we continue to engage. It’s why we continue to push on this because it is an important factor for access to patients. And so I think this is just a process that has to play out.

Unidentified Analyst: Okay. Yes, understood. And then I guess the last one, have you guys – you might have said it earlier, have you guys given an expected timeline for when you believe you can get the label expansion for adolescent population. I know you submitted on May 8th, maybe could you remind us of the timeline for that?

Eddie Martucci: Sure. So, there is no explicit timeline stated. The FDA has internal guidance in terms of their own clock and how they want to review. But there is no date. There is no – in this regulatory type, there is no kind of PDUFA, MDUFA date. And so it is – we can’t say it’s actively under review. We are working with FDA, but we can’t guide on an exact timeframe when the final decision would be reached.

Unidentified Analyst: Okay. It sounds good. Thanks for the questions.