Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q4 2022 Earnings Call Transcript

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John Bencich: Yes. Thanks Franc. So, I mean just to remind everyone, the mechanism for cytisinicline is specific to the nicotine receptors in the brain. So, we do believe there should be broad applicability across smoking, vaping, chewing tobacco, snus, kind of any form of nicotine addiction. I think when we look at e-cigarettes in particular, I think it is difficult to triangulate exactly whether we should expect lower or higher odds ratios there. This is our first foray into this segment. And I think we often hear from our thought leaders and key opinion leaders around the difficulty of getting off of these products. And I think our inclination is likely that it could be a bit more challenging just given the ease and accessibility of basically consuming more nicotine in a simplified manner than what you see with traditional cigarettes.

But I think that’s kind of the beauty of this trial. It will give us a firm best baseline of how we would need to power future trials in this category. So, I think any activity here is going to be positively received. And I think for over an odds ratio of two, which is what we see with existing smoking cessation products, is kind of the minimum entry point. I think anything there or above would be considered a win in this category.

Francois Brisebois: Okay. That’s helpful. And then maybe on the commercial front, in terms of €“ it’s a very large market, you talked about partnering discussions, but is there any way to attack this market by yourself, or like, I guess what I am asking is, are the prescribers kind of concentrated in certain areas where €“ a certain amount of prescribers actually do most of the market and it’s approachable, or is this just too big to take on alone?

John Bencich: Yes. Thanks for the question, Franc. So, our belief has always been that this product is best suited in the hands of a pharma or a large biotech group that already has an existing primary care footprint in place. And I think that’s something that we have been in discussions with potential partners, and that will continue with data. We think that the data sets in Q2 are going to be instrumental in furthering those discussions. With that being said, if this is in our hands, as we get to market, we do see a real opportunity to move this ahead in an efficient, cost-efficient manner. And there is, I think as you are alluding to, quite a bit of efficiency at the top three deciles. So, if we look at kind of this category overall, 30%, at least looking at historical Chantix scripts, were being written by about 7% of the physicians in this category or about 11,000.

And we think that’s an addressable segment to go after. And just looking at that alone would be a $300 million to $400 million opportunity before reinvesting and expanding beyond that. So, we do think there is the path. But at the end of the day, we think this is best suited in the hands of a large pharma.

Francois Brisebois: Understood. Alright. Thank you very much.

Operator: Thank you. We have reached end of our question-and-answer session. I would like to turn the floor back over to management for any further or closing comments.

John Bencich: Great. Thanks Kevin. Thanks everyone for joining us today. We appreciate all the support over 2022. We are very excited about what’s ahead of us and we look forward to bringing further updates as we move into the second quarter and through both ORCA-V1 and ORCA-3 top line results. So, thanks everyone for joining us today.

Operator: Thank you. That does conclude today’s teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

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