By John Vandermosten, CFA
NASDAQ:ACHV
READ THE FULL ACHV RESEARCH REPORT
Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported 2024 results sharing progress with the new drug application (NDA) for cytisinicline and narrowing its anticipated submission date to late 2Q:25. Chief Medical Officer Dr. Jacobs and her team are compiling the various required components for the document and are ensuring that all the required steps are completed. Over the last few months, Achieve has added new board members and executives and completed the initial portion of its ORCA-OL study which will generate critical safety data to be included in the NDA for smoking cessation. The R&D team held the end of Phase II (EoP2) meeting with the FDA to finalize the study design for the pivotal vaping trial. Management has shared its recent accomplishments at investor events including the Jefferies London Healthcare conference in November and the Piper Sandler Healthcare conference in December in New York. Management also participated in one-on-one meetings during the JP Morgan Healthcare Conference in San Francisco in January and the Barclays Healthcare Conference the day after the earnings report.
Financial and Operational Results
Achieve’s 2024 financial and operational results were provided in a press release, filing of Form 10-K and a webcast which provided an opportunity for analysts to ask questions. No revenues were reported for 2024. Operating expense was $39.1 million producing a net loss of ($39.8) million or ($1.24) per share. For the year ending December 31st, 2024 and versus the same comparable prior year period:
- Research & development expense totaled $22.8 million, up 44% from $15.8 million, due to the initiation and enrollment of the ORCA-OL open label safety trial in May 2024;
- General & administrative expense was $16.3 million, up 42% from $11.4 million on higher employee expenses, including commercial launch preparation costs, severance costs, consulting costs and legal expenses associated with patent activities and general corporate activities;
- Net other expense was ($758,000) vs. ($2.6) million as interest income was more than offset by interest expense lapping recognition of a loss on extinguishment of the 2023 SVB convertible term loan in the prior period;
- Net loss was ($39.8) million vs. ($29.8) million or ($1.24) and ($1.50) per share, respectively.
As of December 31st, 2024, cash and equivalents totaled $34.49 million. This amount compares to a $15.5 million balance in cash and equivalents held at the end of 2023 with the increase due to the February 2024 equity raise. Achieve carries convertible debt of $9.9 million on the balance sheet which includes accrued interest. The company refinanced its debt agreement with Silicon Valley Bank (SVB), extending maturity until the end of 2027. Achieve is eligible to draw an additional $5 million from the facility following FDA acceptance of its new drug application (NDA). Cash used in operations during 2024 was ($29.8) million versus ($24.5) million in the prior year period. Management estimates that the company has sufficient cash to support operations until 3Q:25.
Commercial Launch Preparation
Achieve is developing a commercialization plan which will target the most receptive providers and patients that have the highest likelihood of recognizing the value provided by cytisinicline. During the 2024 earnings call, management provided a laundry list of efforts that are underway. The label is being developed, packaging is being finalized and the team is in the process of selecting its third-party logistics partner. Launch readiness activities are centered on awareness, access and availability. Achieve will soon engage with payors to discuss pricing, payment, contract and access requirements. A targeted digital campaign will be the primary channel for the commercialization team which will identify high-volume varenicline subscribers and highly motivated quitters.
Summary
Achieve is continuing to develop its NDA having completed the compilation of Phase I, II and III study reports, finalizing the summary of efficacy documents and soon moving on to the summary of safety documents. The Chemistry, Manufacturing and Controls (CMC) section is near completion. The team is on track for a 2Q:25 submission. Following the turnover of the NDA to the FDA, Achieve will turn to analyzing the data from the last 100 patients in the ORCA-OL safety trial and prepare for the pivotal vaping trial. Pre-commercialization activities are ongoing and the team is narrowing its focus to the most likely providers and patients that will be receptive to and benefit from cytisinicline. Achieve has outlined its timeline and we anticipate FDA approval some time in 2Q:26 with commercialization and first sales to begin in 2H:26. While the team is moving forward under the assumption that it will commercialize cytisinicline itself, an established pharmaceutical company could either buy out the company or license all or part of the available geographies. We see cytisinicline as a material improvement over existing nicotine cessation products with substantially reduced side effects, which allows patients to complete their course of therapy and reap the benefits of the naturally derived product.
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