Karuna Therapeutics, Inc. (NASDAQ:KRTX) Q3 2023 Earnings Call Transcript

Bill Meury : Thanks for the question, Jay.

Jay Olson : Thank you.

Operator: Your next question is from the line of Jeff Hung with Morgan Stanley.

Jeff Hung : Thanks for taking my question. What is the latest feedback you’re hearing from payers on KarXT? And how is the benefit on cognition resonating with payers and clinicians. Thanks.

Bill Meury : Yeah. Great question, and I’ll just make a couple of comments, and then I’ll turn it over to Will Kane. We’ve already started scientific exchange meetings with Medicaid programs all across the United States. So we’re now more than 12 months away from launch. We’re going to have plenty of opportunity to sort of lay the proper groundwork so that we achieve relatively high level of formulary coverage during the first year on the market. I think we’ve already been to about 14 Medicaid programs, maybe more over the past several months. And I think the opportunity here for us to carve out a position on the formularies for KarXT is pretty significant. They haven’t had a novel pharmacological class in three decades. I think if I was — if we were getting ready to introduce another D2 antagonist, I think conversations with payers may be a little bit different, but this isn’t that. With that, I’ll turn it over to Will.

Will Kane : Sure. Thanks, Bill. So I’m particularly pleased with the interactions we’ve had to date with the payer community. Since we initiated scientific exchange in September, we’ve had over two dozen interactions across channels, Medicaid, Medicare Part D and also commercial. And we have more than a dozen just on meeting scheduled between now and the end of the year, and that number continues to go up. I think it reflects a couple of things. One is there is interest, and we — I’ve heard this directly in new treatment options for patients with serious mental illness in this case, particularly schizophrenia. There is — one of the things the preapproval information exchange allows us the opportunity to learn, if you will, almost in real time as data is presented into medical meetings, et cetera.

And so they look forward to that interaction, which is something we can really capitalize on over the next 12 months. The data is well received. I think they certainly appreciate the unique mechanism of KarXT relative to the products that they’re currently offering on their formularies. They really dive into some of the data we present, particularly the total PANSS, but questions about the subscales, which we find to be encouraging and of course, the fundamentally different safety and tolerability profile that’s reflected in the data to date. They do, to your question, have a real appreciation for the three symptom domains of schizophrenia, the positive, the negative anticognitive they know, just as the clinical community knows where the deficits are and they have relatively good drugs on the positive symptoms, but where the needs are negative and cognitive.

So they’re very interested to learn more about KarXT’s evolving clinical program and where the drug may actually be able to offer potential benefits there. So far, I think, really engaging and positive and every one of them has welcomed the opportunity to come back in the future as we present more clinical data to continue to learn more over the next 10 to 12 months.

Bill Meury : And the only thing I would add is just in general, in the area of mental health I would say every corner of the healthcare system right now is moving in the right direction. In other words, we just talked about payers and even state governments are rethinking policies as it relates to formularies and reducing the use of certain drug utilization management sort of techniques to control prescribing and we see fewer and fewer states using prior authorizations. In fact, I think in 14 states, there’s no PA allowed. You also see the elimination or the reduction in the use of step edits, and I think these are very, very good trends. If you take a look at patient advocacy groups that are doing more work than ever before to reduce stigma in isolation.

And then if you look at the providers, there are more community mental health centers being set up in communities all across the United States. And I think all of these trends are more tailwinds than they are headwinds and will enable coverage and access to KarXT and frankly, and the other new compound that’s introduced in the United States for serious mental illness? And I think it’s a very different dynamic in mental health as compared to other therapeutic areas across those aspects of the market, and there’s more momentum than there has been in years. And so that puts us in a very good position when we start to introduce KarXT in the United States next year. Thanks for the question.

Operator: Next question is from the line of Salveen Richter with Goldman Sachs.

Unidentified Analyst: Good morning. This is [indiscernible] on for Salveen. Just on the KarXT launch next year. Could you provide some color on what the early days of launch could look like? Are there specific physicians or geographies that you’re most interested in? And then on KAR-2618, I guess, is there a certain population with an MDD that would be most suitable for this asset? Thank you.

Bill Meury : Yeah. Thank you for the question. I’ll turn it over to Will. I would just say, as we think about the introduction of KarXT in the United States. This is going to be a broad-based program. There is great anticipation in the psychiatric community in the nurse practitioner community, for KarXT. And we’re going to cover as many physicians as many as nurse practitioners as many community mental health centers as can be covered. And of course, we have a lot of data that will instruct exactly where we deploy our sales organization, our managed care access teams, but there’ll be a full comprehensive well-funded program here. And I don’t think that there’s a psychiatrist or a nurse practitioner in the United States that’s not interested and at least evaluating KarXT.

The data from the EMERGENT 1, 2 and 3 program, of course, still under review at the FDA, but it’s very, very compelling. It’s a completely novel approach. It may be complementary to the D2 antagonist. And so our job is to make sure everyone is aware of those data that they get a complete, accurate balance presentation of all the information that we have, which would be consistent with our label, and then they’ll try it in patients that are either new patients, switched patients or patients perhaps that they see a utility and add on although we wouldn’t have that indication at launch. And so there’ll be no aspect of this market that we leave out and preparing it for launch.