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

Michael Higgins: Hey guys. Thanks for taking the questions. Congrats on completing enrollment in two studies at once. I look forward to seeing the data. Question for you guys and Cindy, if you are available, since 2018, you have had an agreement with the FDA on cytisinicline pediatric study plan. Since obviously, vaping has become more important as you have ORCA-V1 results coming up next quarter. Just curious if the agreement with the FDA on your pediatric plan has changed in any way if you still expect to get a six-month extension following approval? Thanks.

John Bencich: Yes. Thanks, Michael. I will hand that one over to Cindy.

Cindy Jacobs: No, it has not changed in regards to approval with our indication of smoking cessation. If we get positive data with our V1 and we move forward with that as a possible additional indication I am sure that, that will have follow-on discussion, but not for smoking cessation at this time.

Michael Higgins: Okay. Very good. And a question for Jaime, if available or John, maybe you can help too. Anything notable you are seeing in generic Chantix products out there ahead of the cytisinicline is likely entry? Thanks.

John Bencich: Yes, great question. Go ahead, Jaime.

Jaime Xinos: Go ahead, brother. Go ahead.

John Bencich: Yes. I was just going to say just with respect to generic sales, as I think we have been updating folks over the course of 2022, we did see Endo’s year-end earnings results and they had over $300 million of generic Chantix sales for year-end 2022. So, I think it continues to demonstrate just how robust this market remains, and that’s with virtually no sales and marketing expenses that they are deploying there, just a pure substitution play. And that’s only about half of the unit sales that Pfizer was making with Chantix before it was withdrawn. So, I think overall, we are encouraged from what we are seeing on the generic side. And Jaime, feel free to jump in with anything else you would like to add.

Jaime Xinos: No, I think you covered it. Thanks John.

Michael Higgins: If I could, just a quick follow-up, if the unit sales are roughly half of Pfizer’s, where do you think those patients are going? Are they just not getting the treatment that they did prior?

John Bencich: Yes. I think our inclination is that when Pfizer was having issues with the manufacturing and carcinogen problem with Chantix, there was a number of docs that just frankly stopped writing. And I think what we have heard from Endo is that they are going to be back out into the market with a bit of reminders that there is a product back available to see if they can start to penetrate those 50% that did drop off with the manufacturing issue.

Michael Higgins: Interesting. Appreciate it. Thanks guys.

Operator: Thank you. Next question is coming from Francois Brisebois from Oppenheimer. Your line is now live.

Francois Brisebois: Hey John. Thanks for taking my questions. Just in terms of e-cigarettes will be coming out first. You talked about the mechanism of action making you comfortable that cytisinicline should work as well or at least should work in e-cigarette users. In terms of odds ratio, I guess the question is, do you think it should work as well, or any €“ just any more color on the mechanism? And why it should work in e-cigarettes, especially given that that trial will read out first? Thank you.