ACHV
Achieve Life Sciences, Inc.4.3800
-0.1100-2.45%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
FY Q4 '25
Supply chain details dominate Q&A
Q&A fleshed out manufacturing contingencies post-NDA site's FDA observations, affirming June 20, 2026 PDUFA unchanged while Adare U.S. production ramps post-approval in Q3 and Sopharma advances for later addition. Management revealed over three years' stockpiled starting material. H1 2027 launch buys time for supply beyond commercial readiness, plus payer outreach (40 Q1 meetings) and vaping trial site selection for H1 2026 kickoff. Analysts probed supply risks; answers were direct. No walk-backs, just operational depth. Supply chain fortifies the path to approval.
Key Stats
Market Cap
233.16MP/E (TTM)
-Basic EPS (TTM)
-1.35Dividend Yield
0%Recent Filings
8-K
Adare manufacturing partnership announced
Achieve Life Sciences reported Q4 and full-year 2025 net losses of $14.7M and $54.7M, with cash at $36.4M as of December 31. Key move: partnered with U.S.-based Adare Pharma for cytisinicline manufacturing to cut import risks and costs amid FDA observations at another site. PDUFA target holds June 20, 2026. Supply chain fortified.
10-K
FY2025 results
Achieve Life Sciences posted FY2025 net loss of $54.6M on $23.0M R&D and $31.9M G&A, up from $39.8M loss in 2024, driven by commercial launch prep and ORCA-OL trial completion in Q3. Q4 saw NDA acceptance by FDA in September with PDUFA June 20, 2026, though third-party manufacturer observations risk delay; ORCA-OL met long-term safety goals with 479 subjects. Cash fell to $36.4M from operations, offset by $51.5M financing including June offering and $15M SVB debt draw. $15M debt matures 2028. Going concern doubt looms without new capital.
10-Q
Q3 FY2025 results
Achieve Life Sciences posted Q3 net loss of $14.4M, up 15% y/y from $12.5M as operating expenses climbed to $14.7M—R&D fell to $5.3M (down 30% y/y on ORCA-OL wind-down) while G&A doubled to $9.4M on commercial prep. Nine-month net loss hit $40.0M (vs $27.5M y/y), with $31.5M cash burn; June 2025 offering boosted cash to $48.1M, yet going concern doubt lingers. $10M convertible debt (maturing 2027) carries ~7% rate. Cash lasts into H2 2026. FDA NDA review awaits PDUFA June 2026. Supply dispute with Sopharma unresolved.
8-K
Q3 loss, FDA milestones hit
Achieve Life Sciences reported Q3 2025 net loss of $14.4M on $14.7M operating expenses, with cash at $48.1M. FDA accepted cytisinicline NDA for smoking cessation, setting PDUFA date June 20, 2026; awarded rare CNPV for vaping cessation. New CLO strengthens team. Cash burn accelerates, yet runway supports approval wait.
8-K
CMO Jacobs resigns, consults on
Achieve Life Sciences' Chief Medical Officer and President Dr. Cindy Jacobs resigned effective October 6, 2025, but will consult until FDA approval of the cytisinicline NDA. She receives $101,296 prorated bonus, accelerated vesting on 2023-2024 options post-consultancy, and $10,000 legal fee reimbursement. Leadership transitions smoothly amid key drug pursuit.
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