BioXcel Therapeutics Inc at UBS Global Healthcare Conference Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Super. Thank you. So maybe let's talk about the IGALMI pricing. You covered this a bit on the launch call, but I'd love to just discuss a bit more the rationale for the price point. And then just walk us through the additional measures you're taking to drive this -- to drive usage in the hospital setting and kind of get this through the P&T committees as fast as possible.

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : The FDA is requiring a post-approval safety study. Could you just -- presuming this as expected from your discussions with the FDA, could you just talk about some of the rationale behind that? And what you need to satisfy to ultimately give FDA comfort at the end of that trial?

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Super. In terms of -- it's a process to get to your P&T committees. And typically, from our seat, we think it's around sort of 6 to 12 month time frame. Does that seem reasonable from your point of view? And as you think about just clearing that sort of process hurdle, when -- is providing revenue guidance something you would expect to eventually do? And can you broadly give us a time line when this could occur? Could it be a '23 event? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 23, 2022 / 2:00PM, BTAI.OQ - BioXcel Therapeutics Inc at UBS Global Healthcare Conference

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Can you talk about the commercial infrastructure. And so if there's a process that's going to take 6 to 12 months, are you going to titrate the size of the sales force to match that? Is everyone in place now and just ready to go? How should we think about that? And then down the line -- and if you -- the more numbers you can give, the better, obviously, and then down the line, what's the incremental build you would need for agitation in Alzheimer's?

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : And just as we think about the launch, 2 things. I think you talked about it would be difficult for us to track. But just if you could confirm that from the usual third-party datasets we get. And then as we think about how we model net pricing based on our anticipated demand, how should we think about that from a sampling, discounting early on in the launch phase?

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : And then as we think about the geographic expansion, any major differences or challenges you anticipate from the EMA filing and regulatory point of view versus your experience with FDA?

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : And if you could just remind us of those time lines, that would be helpful.

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : On the EMA side, the dexmedetomidine, which is the active ingredient in IGALMI, the EMA recently updated that label in ICU use to just to know to higher mortality seen in certain age groups. Has that something that's come up at all in any discussions? And do you -- is there any index of concern on your part about that? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 23, 2022 / 2:00PM, BTAI.OQ - BioXcel Therapeutics Inc at UBS Global Healthcare Conference

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Okay. Great. As we think about the path to expanding the label to remove the requirement for medical supervision, what does that look like from a process perspective?

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Okay. Great. In terms of -- I guess, the next page of indication, Alzheimer's dementia. Before we just talk about the pathway there, can you just remind us why originally, I think you were pursuing the broader indication of just agitation in dementia and then you narrowed it down to Alzheimer's dementia. If you can just remind us of that.

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Perfect. And then can you walk us through the development pathway in Alzheimer's dementia and give us some of the time lines we should expect there?

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Interesting. Okay. And actually, this brings me back on to the pricing, because I think on your -- on the call when you disclosed pricing, you said that you might revisit it when you come to expand the label, expand into other indications. Could you just talk about conceptually how you're thinking about that and how it could change? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 23, 2022 / 2:00PM, BTAI.OQ - BioXcel Therapeutics Inc at UBS Global Healthcare Conference

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : I wanted to talk a little bit about the AI platform. I think it feels like on the calls, you don't get asked a lot about it. But when we meet, I know it's something you're very excited about, and it's clearly led to the development of IGALMI. So maybe you could just talk us through the AI platform and maybe open up the common a little bit and just describe how that led to IGALMI and 701, it'd be great to just get a bit of a better understanding of that.

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : And then as you think about using that platform on a go-forward basis, how often are you challenging the platform with new information, target identification? Do you have sort of a target number of new assets you want to come out of the platform on an annual basis? How are you utilizing it?

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Yes, that makes sense. So maybe let's use the remaining time on 701. You've talked about the formation of the OnkosXcel subsidiary. Walk us through the strategic rationale for that, when we can expect more details? What can you tell us now? That would be helpful.

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : And maybe just give us a quick refresh on 701 in terms of the development path. What are the next major readouts we should expect in the next 12 to 18 months? And then -- and we're still waiting on some of the primary details on OnkosXcel in terms of division of finances, division of human capital, human resources. So walk us through when we should expect those as well.

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Do you say FDA signed up on that, or that's just based on...

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : And the anticipated timeline for the readout of that trial is when?

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : And what's the efficacy followed threshold that you're looking to exceed this to be classified a success?

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Great. I think we're actually at the end of time. So thank you very much. Congrats again on the IGALMI approval and ongoing launch. We're looking forward to the updates there. So Vimal, Matt and Vince. Thank you. It's been great. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 23, 2022 / 2:00PM, BTAI.OQ - BioXcel Therapeutics Inc at UBS Global Healthcare Conference