Q2 2023 Achieve Life Sciences Inc Earnings Call
Speaker 1: A
Speaker 2: Greetings. Welcome to the Achieved Life Sciences second quarter 2023 earnings conference call and webcast. At this time, all participants are in a listen-only mode.
Speaker 2: A question and answer session will follow the formal presentation. If anyone should require operator assistance during the call, please press star zero on your telephone keypad.
Speaker 3: As a reminder, this conference is being recorded. At this time, I would like to hand the call over to Nicole Jones, Investor Relations. Thank you. You may begin. Thank you, operator, and thank you to everyone for joining the call today. Today from Achieve, we have John Bintich, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, and Jerry Wan, Principal Accounting Officer. Achieve's management will be available for Q&A after the prepared remarks. I'd like to remind everyone that today's conference call contains forward-looking statements based on current experience.
Speaker 3: that could affect the company. I'll now turn the call over to John .
Speaker 4: Thank you Nicole and to everyone who has joined us this morning. The first half of 2023 has seen the culmination of our ambitions to bring the first smoking cessation product to market in nearly 20 years take a meaningful step forward. Several milestones were met in close proximity.
Speaker 4: all of which contributed substantial value to the CytocinicLink program and to shareholders. Firstly, the ORCA III Phase III trial results in May, validated and closely replicated those of the ORCA II trial and demonstrated significant efficacy with a benign side effect profile.
Speaker 4: Secondly, just prior to the excellent ORCA3 results, Achieve announced positive results from the ORCA V1 Phase 2 clinical trial in 160 e-cigarette users.
Speaker 4: Thirdly, Achieve renegotiated the terms of our convertible loan agreement extending the maturity date.
Speaker 4: Overall, significant progress was made on many fronts. We look forward to continuing the campaign to highlight the value of cytosinocline and the underlying public health importance of cytosinocline in the U.S. and globally. With both phase-three smoking cessation clinical trials completed in over 1,500 subjects, the combined results confirm the compelling efficacy and safety evidence of cytosinocline necessary to pursue FDA approval for smoking cessation.
Speaker 4: We are aiming to make an NDA submission in the first half of 2024, and if approved, sinocinocline could be the first new prescription treatment made available to the roughly 28 million smokers in the US in nearly two decades. In parallel with the regulatory activities, we continue to focus on commercial readiness with attention on CMC and supply chain, as well as partnering discussions with interested parties around the globe who also believe in the immense potential of cytocinocline.
Speaker 4: Additionally, we can now expand our ambitions beyond the smoking cessation market and into the broader nicotine addiction market.
Speaker 4: As you are aware, vaping is expanding in popularity and serious concerns are continuing to emerge about both the short and long-term safety of these products.
Speaker 4: Cytocinocline has the potential to be a first-in-class product for vaping cessation. Combined with the potential target market is nearly 40 million Americans who are currently either smoking or using e-cigarettes. Looking at the data from both trials, specifically the 12-week treatment duration,
Speaker 5: So two questions for us. So last week, EndoSpar Pharmaceuticals sued Zydus, saying it must be infringing its nitrosamine impurity technique in a genetic varenetine. And also last week, the FDA issued guidance that established a framework for assessing an acceptable level of nitrosamine in a drug protocol. So are you confident that the manufacturing of your drug is within the FDA's limit? And if so, is this something you can monetize with generic companies? And the second question we have is, do you plan to hire a marketing executive with experience in running a launch, preferably one doing it without a pharma budget into a large non-orphan market?
Speaker 4: And if so, when? Thanks. Yes, Zohada, thanks for the questions there. So we have been tracking what's going on with the Endo launch. We did see the sales last year of north of 300 million and the recent suit going across to Zidus in terms of potential IP violations with respect to another Chantix generic that's hitting the market. None of the IP that we see sitting over there, you know, reads on to what we're doing. We do think we have an opportunity for new IP around formulations on our side with respect to controlling for nitrosamines that we think could be blocking for others in this space. So that's something that we're actively working on in the background as we proceed. And then obviously working in collaboration with FDA on final nitrosamine limits with respect to our drug product. So that's something that will continue as we proceed through an NDA. So with respect to your second question on hiring another exec, this is not anything that we currently have planned at the moment. We've got a head of commercial that's leading the charge at the moment. And our focus, I think as you rightly indicated, is going to be on, you know, planning for a very nimble and efficient launch in parallel with continuing the partnering discussions.
allowing it to be prescribed as such before you know diving into what we believe will be a difficult population to treat. Got it, thanks for the questions and congrats on the progress this quarter. Thanks Laura.
Thank you. Our next question has come from the line of John VanderMose with Zach's research. Please proceed with your questions. Thank you and good morning John . How are you doing? Great. So in our research we have identified a number of potential suitors for Achieve including Pfizer, GSK, Her Herco, Dr. Reyes and a bunch of others. Do you think that it might make sense to have one deal or potentially multiple deals? You know because there's different regions just may have different opportunities you know that I'm thinking New Zealand, Australia for example there's a lot of focus on cytosine decline and and team vaping and a whole bunch of other things that make that a particularly attractive region. Is there anything that you know might cause you to split it up or does it make more sense to have one partner that fully commercializes the product? Yeah thanks for the question John . With respect to our ideal partner it would be a single global partner that you know that has capabilities you know in all the various territories around the world that we're interested in. I think with that being said you know given that the US has been such a substantial portion of revenues globally when looking at Chantix as a proxy, strong US capabilities are going to be be critical for this launch. With that being said you know we've seen a tremendous amount of interest out of Asia over the years. We have seen multiple term sheets for deals in those regions and we specifically not move forward with them so we can you play out the potential for a larger single transaction. But I think there are opportunities I think like you said you know across the globe.