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Achieve Life Sciences (ACHV)
:ACHV
Earnings Data
Report Date
May 08, 2025TBA Not Confirmed
Period Ending
2025 (Q1)Consensus EPS Forecast
-0.38Last Year’s EPS
-0.26Same Quarter Last Year
Strong Buy
Based on 4 Analysts Ratings
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Earnings Call Summary
Earnings Call Date:Mar 11, 2025
|% Change Since: -9.15%
|Next Earnings Date:May 08, 2025
Earnings Call Sentiment|Neutral
The earnings call reflects a company on the cusp of significant milestones with the upcoming NDA submission for cytisinicline, highlighting strong progress in clinical trials and financial health. However, challenges remain, particularly in securing financing for future vaping cessation trials and managing high operating expenses. The overall sentiment is cautiously optimistic, with substantial achievements in place but significant dependencies on future regulatory approvals.Company Guidance
In the Achieve Life Sciences fourth quarter and year-end 2024 earnings call, the company provided several key metrics and guidance for the upcoming period. Achieve plans to submit the New Drug Application (NDA) for cytisinicline, a treatment for nicotine dependence, to the FDA by the end of the second quarter of 2025. The company highlighted that the cytisinicline program achieved critical milestones, including the successful enrollment of 479 participants in the ORCA Open Label Long-Term Safety Exposure clinical trial, meeting the FDA requirement of treating 300 subjects with cytisinicline for a cumulative six months. Financially, Achieve reported a cash balance of $34.4 million as of December 31, 2024, with operating expenses for the fourth quarter and full year totaling $12.2 million and $39.1 million, respectively. The anticipated commercial launch of cytisinicline is set for the third quarter of 2026, with a focus on converting high-volume varenicline prescribers and leveraging strategic partnerships to optimize market entry. The company is also planning to initiate a Phase 3 trial for vaping cessation in the first half of 2026, depending on financing.NDA Submission for Cytisinicline
Achieve Life Sciences plans to submit the NDA for cytisinicline as a treatment for nicotine dependence for smoking cessation with the FDA at the end of the next quarter, marking a major milestone as the first new drug for nicotine dependence in nearly 20 years.
Breakthrough Therapy Designation
Cytisinicline received Breakthrough Therapy designation for vaping cessation, highlighting its potential as a first-in-class treatment for e-cigarette or vaping cessation.
Financial Health
The company's cash, cash equivalents, and marketable securities were $34.4 million as of December 31, 2024, up from $15.6 million on December 31, 2023, indicating a strong financial position to support operations into the third quarter of 2025.
Leadership Strengthening
The leadership team was bolstered with the hiring of a new CFO, Mark Oki, and the appointment of Dr. Kristen Slaoui and Nancy Phelan to the Board of Directors, bringing extensive leadership experience.
Successful Clinical Trials
Completion of the ORCA Open Label Long-Term Safety Exposure clinical trial and meeting the FDA’s requirement of treating 300 subjects for six months with cytisinicline, advancing towards NDA submission.
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ACHV Earnings History
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
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ACHV Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
| Mar 11, 2025 | $3.06 | $2.92 | -4.58% |
| Nov 07, 2024 | $5.00 | $4.63 | -7.40% |
| Aug 13, 2024 | $4.36 | $4.38 | +0.46% |
| May 09, 2024 | $4.53 | $4.61 | +1.77% |
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.
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FAQ
When does Achieve Life Sciences (ACHV) report earnings?
Achieve Life Sciences (ACHV) is schdueled to report earning on May 08, 2025, TBA Not Confirmed.
What is Achieve Life Sciences (ACHV) earnings time?
Achieve Life Sciences (ACHV) earnings time is at May 08, 2025, TBA Not 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 (Q1) is -0.38.
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