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Achieve Life Sciences Inc (ACHV)
NASDAQ:ACHV
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Achieve Life Sciences
(NASDAQ:ACHV)
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Rating:52Neutral
Price Target:
$5.50
▼(-1.96% Downside)
The score is held back primarily by weak financial performance (no revenue, heavy losses, and material cash burn) and limited valuation support from ongoing unprofitability. These are partly offset by positive earnings-call catalysts around NDA progress and expedited review potential, while technical indicators are broadly neutral.
Positive Factors
Clinical Trial Progress
Successful clinical trials demonstrate the efficacy and safety of cytisinicline, positioning Achieve Life Sciences favorably for NDA submission and potential market entry, which could significantly enhance revenue prospects.
Financial Health
Improved financial health with increased cash reserves provides a buffer to support ongoing operations and R&D activities, reducing immediate financial risk and enabling strategic investments in drug development.
Leadership Strengthening
Strengthening the leadership team with experienced professionals enhances strategic decision-making and governance, potentially improving operational efficiency and execution of growth strategies.
Negative Factors
High Operating Expenses
High operating expenses contribute to ongoing financial losses, which may necessitate further capital raising and could delay profitability, impacting the company's long-term financial sustainability.
Dependence on FDA Approval
Reliance on FDA approval introduces regulatory risk, as any delays or rejections could significantly impact the company's ability to commercialize its lead product and achieve revenue generation.
Challenges in Vaping Cessation
Financing challenges for the vaping cessation trial could delay product development and market entry, affecting the company's ability to diversify its product pipeline and revenue streams.
Achieve Life Sciences (ACHV) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$298.64M
Dividend YieldN/A
Average Volume (3M)598.87K
Price to Earnings (P/E)―
Beta (1Y)1.90
Revenue GrowthN/A
EPS Growth-22.06%
CountryUS
Employees25
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.28
Shares Outstanding53,233,990
10 Day Avg. Volume663,480
30 Day Avg. Volume598,865
Financial Highlights & Ratios
PEG Ratio0.16
Price to Book (P/B)5.40
Price to Sales (P/S)0.00
P/FCF Ratio-3.79
Enterprise Value/Market Cap0.41
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-1.05K
Enterprise Value/Ebitda-2.39
Forecast
1Y Price Target
$15.33Price Target Upside173.26% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering6
EPS Forecast (FY)-1.21
Revenue Forecast (FY)$15.81M
Achieve Life Sciences Business Overview & Revenue Model
Company DescriptionAchieve Life Sciences, Inc., a clinical-stage pharmaceutical company, develops and commercializes of cytisinicline for smoking cessation and nicotine addiction in Canada, the United States, and the United Kingdom. The company offers cytisinicline, a plant-based alkaloid that interacts with nicotine receptors in the brain that reduce the severity of nicotine withdrawal symptoms. It has license agreements with Sopharma AD and University of Bristol. The company is based in Vancouver, Canada.
How the Company Makes MoneyAchieve Life Sciences generates revenue primarily through the development and potential future commercialization of its lead product, cytisinicline, which is currently in clinical trials. The company aims to earn income from the successful approval and sale of cytisinicline, targeting partnerships, licensing agreements, and collaborations with larger pharmaceutical companies to aid in distribution and marketing. Additionally, Achieve seeks funding through public and private investments to support its research and development activities. As it is still in the clinical stage, the company's current revenues are limited, and its financial strategy relies on securing further investment and eventual drug approval for market entry.
Achieve Life Sciences Earnings Call Summary
Earnings Call Date:Nov 06, 2025
(Q3-2025)
| % Change Since: |
Next Earnings Date:Mar 12, 2026
Earnings Call Sentiment Positive
The earnings call highlighted significant regulatory achievements and strategic advancements, particularly in gaining an expedited review for vaping cessation. However, funding needs for further clinical trials and challenges in aligning commercial strategies for two different market entries pose potential risks.Q3-2025 Updates
Positive Updates
FDA Priority Voucher for Vaping Indication
Achieve Life Sciences received a Commissioner's National Priority Voucher from the FDA for cytisinicline in vaping cessation, allowing for expedited NDA review and potential early market entry.
Regulatory Milestones Achieved
FDA accepted the NDA for cytisinicline for smoking cessation with a PDUFA date set for June 20, 2026. A 120-day safety review was also submitted on time.
Positive Outcomes from COPD Studies
Smokers with COPD had higher quit rates on cytisinicline compared to placebo in Phase III trials, indicating cytisinicline's potential to aid a difficult-to-treat population.
Commercial Strategy and AI Integration
Achieve is integrating AI-driven tools for precision targeting in its commercialization strategy, enhancing engagement and optimizing resource allocation.
Strong Financial Position
As of September 30, 2025, Achieve had $48.1 million in cash, cash equivalents, and marketable securities, with a cash runway extending into the second half of 2026.
Negative Updates
Need for Additional Funding
Additional capital will be required to fund the vaping study, as current resources do not cover this expense.
Challenges in Market Entry Timing
The potential launch of cytisinicline for vaping may occur earlier than the smoking cessation launch, posing challenges in aligning commercial infrastructure.
Company Guidance
During the Achieve Life Sciences Third Quarter 2025 Earnings Conference Call, significant advancements were highlighted regarding the company's primary objectives, particularly the NDA submission, acceptance, and anticipated approval for cytisinicline, a treatment aimed at nicotine dependence and smoking cessation. A notable achievement was the FDA's award of a Commissioner's National Priority Voucher (CNPV) for the e-cigarette or vaping indication, expediting the NDA review timeline to 1-2 months from the standard 10-12 months. This expedited timeline could potentially see the launch of cytisinicline 8 months earlier, positioning it as the first FDA-approved treatment for the 60% of people desiring to quit vaping. The FDA has set a PDUFA date of June 20, 2026, for the smoking cessation indication, following the acceptance of the NDA and the timely submission of a 120-day safety review. Additionally, the company has emphasized its data-driven digital commercialization strategy, leveraging AI and machine learning to optimize engagement across healthcare professionals, patients, and payers, ensuring a robust and targeted launch strategy for cytisinicline.Achieve Life Sciences Financial Statement Overview
Summary
Achieve Life Sciences faces challenges typical of early-stage biotech firms, with no revenue, significant losses, and negative cash flows. Improvements in equity and financing inflows offer some stability, but the company remains in a precarious financial position until it can generate consistent revenue streams.Income Statement
Achieve Life Sciences has consistently reported zero revenue, indicating a lack of commercialized products or services. The company has also experienced significant net losses over the years, including a net loss of $39.83 million in 2024. This trend highlights the financial challenges typical in the biotechnology industry during the R&D phase.9
Very Negative
Balance Sheet
The company's debt-to-equity ratio improved significantly in 2024 due to increased stockholders' equity from negative to $20.9 million. However, the company still carries a notable amount of debt relative to its equity. The equity ratio of 54.1% in 2024 suggests a moderate reliance on equity financing, yet the previous negative equity poses potential risks.43
Neutral
Cash Flow
Achieve Life Sciences shows negative operating and free cash flows, consistent with its developmental stage. The operating cash flow to net income ratio indicates cash outflows are aligned with reported losses. While financing activities have provided substantial cash inflows, the negative free cash flow growth highlights ongoing cash burn.12
Very Negative
| Breakdown | TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -117.00K | -229.00K | 0.00 | 0.00 | 0.00 | -255.00K |
| EBITDA | -51.35M | -37.42M | -26.73M | -40.33M | -32.90M | -14.47M |
| Net Income | -52.35M | -39.83M | -29.82M | -42.35M | -33.15M | -14.66M |
Balance Sheet | ||||||
| Total Assets | 52.04M | 38.63M | 19.37M | 29.97M | 47.52M | 40.30M |
| Cash, Cash Equivalents and Short-Term Investments | 48.11M | 34.36M | 15.55M | 24.72M | 43.02M | 35.85M |
| Total Debt | 9.96M | 9.96M | 16.73M | 16.20M | 14.99M | 169.00K |
| Total Liabilities | 18.43M | 17.73M | 20.82M | 21.67M | 19.47M | 3.01M |
| Stockholders Equity | 33.62M | 20.90M | -1.45M | 8.30M | 28.04M | 37.29M |
Cash Flow | ||||||
| Free Cash Flow | -40.68M | -29.77M | -24.50M | -37.57M | -29.44M | -13.49M |
| Operating Cash Flow | -40.68M | -29.77M | -24.48M | -37.57M | -29.44M | -13.47M |
| Investing Cash Flow | 17.12M | -21.58M | -21.00K | 0.00 | 0.00 | -17.00K |
| Financing Cash Flow | 45.95M | 48.53M | 15.28M | 19.32M | 36.61M | 32.68M |
Achieve Life Sciences Technical Analysis
Positive
5.61
Price Trends
4.71
Positive
4.11
Positive
3.43
Positive
Market Momentum
0.29
Negative
67.34
Neutral
84.21
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ACHV, the sentiment is Positive. The current price of 5.61 is above the 20-day moving average (MA) of 4.92, above the 50-day MA of 4.71, and above the 200-day MA of 3.43, indicating a bullish trend. The MACD of 0.29 indicates Negative momentum. The RSI at 67.34 is Neutral, neither overbought nor oversold. The STOCH value of 84.21 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for ACHV.
Achieve Life Sciences Risk Analysis
Achieve Life Sciences disclosed 65 risk factors in its most recent earnings report. Achieve Life Sciences reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Achieve Life Sciences Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
54 Neutral | $297.16M | -12.26 | -31.07% | ― | 158.54% | 66.90% | |
52 Neutral | $298.64M | -4.06 | -161.08% | ― | ― | -22.06% | |
52 Neutral | $172.89M | -2.35 | -260.65% | ― | ― | 3.70% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
50 Neutral | $141.41M | ― | -95.29% | ― | -67.38% | -1076.54% | |
48 Neutral | $147.03M | -1.41 | -26.69% | ― | ― | 25.84% | |
42 Neutral | $38.56M | -0.39 | -240.48% | ― | ― | 2.36% |
* Healthcare Sector Average
ACHV
Achieve Life Sciences
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2.52
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Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.