Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q4 2022 Earnings Conference Call March 16, 2023 4:30 PM ET

Company Participants

Nicole Jones - Investor Relations

John Bencich - Chief Executive Officer

Cindy Jacobs - President and Chief Medical Officer

Jerry Wan - Principal Accounting Officer

Jaime Xinos - Executive Vice President, Commercial

Conference Call Participants

Thomas Flaten - Lake Street Capital

Michael Higgins - Ladenburg Thalmann

Francois Brisebois - Oppenheimer

Operator

Hello and welcome to the Achieve Life Sciences Fourth Quarter 2022 Earnings Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded. It’s now my pleasure to turn the call over to Nicole Jones with CG Capital. Please go ahead, Nicole.

Nicole Jones

Thank you, operator and thank you to everyone for joining the call. Today from Achieve, we have John Bencich, Chief Executive Officer; Dr. Cindy Jacobs, President and Chief Medical Officer; and Jerry Wan, Principal Accounting Officer. Achieve 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 expectations. These statements are only predictions and actual results may vary materially from those projected. Please refer to Achieve documents available on our website and filed with the SEC concerning factors that could affect the company.

I will now turn the call over to John.

John Bencich

Thank you, Nicole and thanks everyone for joining us today. In 2022, we achieved significant milestones that were crucial to advancing cytisinicline and to meeting our key objectives for the year. We are proud to have executed successfully on numerous critical activities, including the completion of our first Phase 3 trial for smoking cessation, which yielded highly positive efficacy and safety results. This outcome confirmed our belief that our new cytisinicline dosage and regimen has the potential to become the new gold standard for treating nicotine dependence.

We secured grant funding to initiate our first vaping cessation trial, which exceeded our expectations in completing enrollment early due to the great enthusiasm at the sites and with study participants who wanted to quit vaping. We also strengthened our intellectual property position, concluding the year with a total of 15 granted patents and 46 pending patents, including expirations extending out until 2042.

Along with our partner, Sopharma, we completed the build-out of a new API facility, expanding our global manufacturing capacity to meet expected commercial requirements. In 2002, we also engaged in numerous productive strategic discussions with potential partners. And finally, we secured capital to ensure completion of our upcoming development milestones. We take great pride in completing these critical activities with the team of only 20 full-time Achieve employees. These accomplishments speak greatly to the expertise of our team in the various roles and their commitment to advancing cytisinicline to make a meaningful impact for public health. We are grateful for their efforts and for the support we continue to receive from our external stakeholders. We made significant progress in 2022. And now we look forward to the year ahead, which promises to be even more exciting.