The earnings call highlighted significant advancements in regulatory submissions, strategic partnerships, and capital acquisition, indicating strong progress toward commercialization. However, the extended timeline to launch and potential pricing challenges present notable hurdles.

Company Guidance

During the Achieve Life Sciences second quarter 2025 earnings call, the company provided guidance on several key metrics and milestones. Achieve successfully submitted a new drug application (NDA) for cytisinicline as a treatment for nicotine dependence to the FDA, marking a significant regulatory milestone. They anticipate receiving the 74-day letter from the FDA in September, which will confirm the acceptance of their NDA for review. Achieve also announced a strategic partnership with Omnicom to support their commercial launch strategy, leveraging Omnicom's experience with over 100 product launches in the past three years. Financially, the company raised $49 million, strengthening their balance sheet with cash and equivalents totaling $55.4 million as of June 30, 2025. This funding is expected to support operations into the second half of 2026. Achieve's leadership shared their commitment to advancing regulatory, commercial, and financial objectives, aiming for a potential product launch in late 2026. The call emphasized the significant market opportunity, with 29 million Americans smoking and over 15 million annually attempting to quit, highlighting the unmet need for effective smoking cessation tools.

Successful NDA Submission for Cytisinicline

Achieve Life Sciences submitted a new drug application (NDA) for cytisinicline as a treatment for nicotine dependence to the FDA, marking a major regulatory milestone.

Strategic Partnership with Omnicom

Achieve formed a strategic commercial partnership with Omnicom to enhance its commercial launch strategy, leveraging Omnicom's expertise in health care marketing and advertising.

Significant Capital Raise

Achieve Life Sciences raised $49.3 million, strengthening its balance sheet and positioning the company to reach critical value inflection points in 2026, including potential product approval.

Positive Patient Survey Results

Patient surveys from the ORCA-OL study showed 98% believed cytisinicline contributed to reducing nicotine dependence, and 99% would recommend it to others.

Regulatory and Safety Milestones Achieved

FDA requested safety data milestones were met, with over 290 participants completing 1 year of cytisinicline treatment, ensuring robust safety data for the NDA.

Achieve Life Sciences (ACHV) Earnings, Revenues Date & History

The upcoming earnings date is based on a company’s previous reporting, and may be updated when the actual date is announced

Daily Earnings Calendar >

ACHV Earnings History

Report Date	Fiscal Quarter	Forecast / EPS	Last Year's EPS	EPS YoY Change	Slides	Play Transcript
Nov 06, 2025	2025 (Q3)	-0.24 / -	-0.36	―	―	―
Aug 07, 2025	2025 (Q2)	-0.37 / -0.37	-0.25	-48.00% (-0.12)	―
May 13, 2025	2025 (Q1)	-0.38 / -0.37	-0.26	-42.31% (-0.11)	―
Mar 11, 2025	2024 (Q4)	-0.34 / -0.36	-0.26	-38.46% (-0.10)	―
Nov 07, 2024	2024 (Q3)	-0.27 / -0.36	-0.34	-5.88% (-0.02)	―
Aug 13, 2024	2024 (Q2)	-0.24 / -0.25	-0.43	41.86% (+0.18)	―
May 09, 2024	2024 (Q1)	-0.24 / -0.26	-0.5	48.00% (+0.24)	―
Mar 28, 2024	2023 (Q4)	-0.31 / -0.26	-0.83	68.67% (+0.57)	―
Nov 09, 2023	2023 (Q3)	-0.37 / -0.34	-1.35	74.81% (+1.01)	―
Aug 14, 2023	2023 (Q2)	-0.41 / -0.43	-1.08	60.19% (+0.65)	―

The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.

Beat

Missed

ACHV Earnings-Related Price Changes

Report Date	Price 1 Day Before	Price 1 Day After	Percentage Change
Aug 07, 2025	$2.64	$2.64	0.00%
May 13, 2025	$2.48	$2.65	+6.85%
Mar 11, 2025	$3.06	$2.92	-4.58%
Nov 07, 2024	$5.00	$4.63	-7.40%

Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.

FAQ

When does Achieve Life Sciences (ACHV) report earnings?

Achieve Life Sciences (ACHV) is schdueled to report earning on Nov 06, 2025, After Close (Confirmed).

What is Achieve Life Sciences (ACHV) earnings time?

Achieve Life Sciences (ACHV) earnings time is at Nov 06, 2025, After Close (Confirmed).

Where can I see when companies are reporting earnings?

You can see which companies are reporting today on our designated earnings calendar.

What companies are reporting earnings today?

You can see a list of the companies which are reporting today on TipRanks earnings calendar.

What is ACHV EPS forecast?

ACHV EPS forecast for the fiscal quarter 2025 (Q3) is -0.24.

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