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Achieve Life Sciences Inc (ACHV)
NASDAQ:ACHV
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Achieve Life Sciences
(NASDAQ:ACHV)
Rating:37Underperform
Price Target:―
Positive Factors
Market Demand
A notable 7 in 10 smokers want to quit, indicating a strong market demand for effective cessation aids.
Product Efficacy
Cytisinicline demonstrated a clinical benefit in smoking cessation with a good tolerability profile in two Phase III trials (ORCA-2 and -3). Cytisinicline was superior to placebo and to current smoking cessation options.
Regulatory Progress
The company has successfully collected long-term safety data for cytisinicline, fulfilling a key NDA submission requirement for smoking cessation.
Negative Factors
Market Competition
The initial focus of ACHV will be on high volume varenicline prescribers, with the commercial team believing they will be able to convince prescribers of varenicline of the superior profile.
Operational Costs
An increase in 2025 and 2026 expense estimates, suggesting higher operational costs for the company in the coming years.
Achieve Life Sciences (ACHV) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$103.01M
Dividend YieldN/A
Average Volume (3M)214.75K
Price to Earnings (P/E)―
Beta (1Y)1.66
Revenue GrowthN/A
EPS Growth19.70%
CountryUS
Employees25
SectorHealthcare
Sector Strength43
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.37
Shares Outstanding34,685,074
10 Day Avg. Volume261,887
30 Day Avg. Volume214,751
Financial Highlights & Ratios
PEG Ratio0.18
Price to Book (P/B)3.88
Price to Sales (P/S)0.00
P/FCF Ratio-2.74
Enterprise Value/Market Cap0.76
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-690.66
Enterprise Value/Ebitda-0.68
Forecast
1Y Price Target
$15.25Price Target Upside401.64% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
Achieve Life Sciences Business Overview & Revenue Model
Company DescriptionAchieve Life Sciences, Inc. (ACHV) is a clinical-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction. Operating primarily within the biopharmaceutical sector, the company's core focus is on addressing the global smoking health crisis by providing an alternative to existing smoking cessation therapies.
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 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.15
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.30
Negative
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.20
Very Negative
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | Gross Profit |
| 0.00 | -228.00K | -236.00K | -250.00K | -255.00K | EBIT |
| -39.07M | -27.25M | -40.80M | -33.09M | -14.75M | EBITDA |
| -37.42M | -26.73M | -40.33M | -32.90M | -14.47M | Net Income Common Stockholders |
| -39.83M | -29.82M | -41.88M | -32.90M | -14.66M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 34.36M | 15.55M | 24.77M | 43.02M | 35.85M | Total Assets |
| 38.63M | 19.37M | 29.97M | 47.52M | 40.30M | Total Debt |
| 9.96M | 16.73M | 16.20M | 73.00K | 169.00K | Net Debt |
| -2.79M | 1.19M | -8.57M | -42.95M | -35.68M | Total Liabilities |
| 17.73M | 20.82M | 21.67M | 19.47M | 3.01M | Stockholders Equity |
| 20.90M | -1.45M | 8.30M | 28.04M | 37.29M |
| Cash Flow | Free Cash Flow | |||
| -29.77M | -24.50M | -37.55M | -29.46M | -13.49M | Operating Cash Flow |
| -29.77M | -24.48M | -37.55M | -29.44M | -13.47M | Investing Cash Flow |
| -21.58M | -21.00K | 0.00 | -17.00K | -17.00K | Financing Cash Flow |
| 48.53M | 15.28M | 19.30M | 36.61M | 32.68M |
Achieve Life Sciences Technical Analysis
Neutral
3.04
Price Trends
2.56
Positive
2.89
Positive
3.70
Negative
Market Momentum
0.17
Negative
57.76
Neutral
79.02
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ACHV, the sentiment is Neutral. The current price of 3.04 is above the 20-day moving average (MA) of 2.66, above the 50-day MA of 2.56, and below the 200-day MA of 3.70, indicating a neutral trend. The MACD of 0.17 indicates Negative momentum. The RSI at 57.76 is Neutral, neither overbought nor oversold. The STOCH value of 79.02 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for ACHV.
Achieve Life Sciences Risk Analysis
Achieve Life Sciences disclosed 66 risk factors in its most recent earnings report. Achieve Life Sciences reported the most risks in the “Tech & Innovation” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 3 New Risks
1.
A Breakthrough Therapy designation by the FDA may not lead to a faster development or regulatory review or approval process for the vaping/ e-cigarette cessation indication and it does not increase the likelihood that our product candidates will receive marketing approval. Q4, 2024
2.
We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations that can harm our business. Q4, 2024
3.
Disruptions at the FDA may slow the time necessary for new products to be reviewed and/or approved, which would adversely affect our business. In addition, there is substantial uncertainty regarding new initiatives and how these might impact the FDA, its implementation of laws, regulations, policies and guidance and its personnel. Similar initiatives may also be directed toward other government agencies. These initiatives could prevent, limit or delay development and regulatory approval of our product candidates, which would adversely affect our business. Q4, 2024
Achieve Life Sciences Peers Comparison
Overall Rating
UnderperformOutperform
Sector (53)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
53 Neutral | $5.14B | 3.06 | -43.57% | 2.81% | 16.81% | -0.12% | |
49 Neutral | $83.71M | ― | -58.80% | ― | -100.00% | -24.28% | |
48 Neutral | $107.26M | ― | -114.74% | ― | 433.43% | 49.04% | |
47 Neutral | $137.56M | ― | -49.23% | ― | 105.85% | 22.13% | |
46 Neutral | $39.69M | ― | -1454.41% | ― | 35.76% | 47.48% | |
41 Neutral | $46.59M | ― | -127.99% | ― | ― | 37.54% | |
37 Underperform | $103.01M | ― | -154.55% | ― | ― | 19.70% |
* Healthcare Sector Average
Performance Comparison
ACHV
Achieve Life Sciences
3.04
-2.37
-43.81%
FATE
Fate Therapeutics
1.16
-2.36
-67.05%
VXRT
Vaxart
0.46
-0.41
-47.13%
ADVM
Adverum Biotechnologies
2.21
-5.39
-70.92%
ANIX
Anixa Biosciences
2.50
0.08
3.31%
BDSX
Biodesix
0.34
-1.11
-76.55%
Achieve Life Sciences Earnings Call Summary
Earnings Call Date:May 13, 2025
(Q1-2025)
| % Change Since: 22.58%|
Next Earnings Date:Aug 07, 2025
Earnings Call Sentiment Positive
The call highlighted Achieve's progress towards NDA submission for cytisinicline, with significant milestones in clinical trials and strong financial management. Despite a reported net loss, the overall tone was optimistic with potential future challenges in commercialization timing.Q1-2025 Updates
Positive Updates
NDA Submission Imminent
Achieve is on track to submit the NDA for cytisinicline next month, marking a significant milestone for the company.
ORCA-OL Trial Progress
Over 100 patients have one-year exposure to cytisinicline as required by the FDA, with 75% of participants remaining on treatment, indicating its tolerability and potential efficacy.
Publication and Recognition
ORCA-3 trial results were published in JAMA Internal Medicine, highlighting cytisinicline's efficacy and tolerability in quitting smoking.
Financial Management
Achieve ended the quarter with $23.2 million in cash, emphasizing strong financial discipline in preparation for the NDA submission and future launch.
Strong Advisory Support
A Scientific Advisory Board meeting with experts from renowned institutions showed significant enthusiasm for cytisinicline.
Negative Updates
Net Loss Reported
Achieve reported a net loss of $12.8 million for the first quarter of 2025.
Uncertainty in Commercialization Timeline
While aiming for a 2026 launch, there is still uncertainty about the exact timing of commercialization post-approval.
Company Guidance
During the Achieve Life Sciences Q1 2025 earnings call, key guidance was provided on the company's progress, particularly focusing on the upcoming NDA submission for cytisinicline, projected for June 2025. Achieve is targeting approval within 12 months post-submission. The open label ORCA-OL trial has shown encouraging results, with over 100 patients completing the FDA-required one-year exposure, reflecting cytisinicline's tolerability and potential efficacy. Approximately 75% of the 479 participants remain on treatment, indicating strong adherence. Financially, the company reported operating expenses of $12.9 million and a net loss of $12.8 million for the first quarter, ending March 31, 2025, with $23.2 million in cash, cash equivalents, and marketable securities. Achieve is keen on managing resources efficiently to extend its cash runway while preparing for a potential commercial launch in 2026.Achieve Life Sciences Corporate Events
Executive/Board Changes
Achieve Life Sciences Announces Board of Directors Changes
Neutral
Jan 10, 2025
Achieve Life Sciences announced changes in its board of directors with the resignation of Dr. Vaughn Himes and the appointment of Nancy R. Phelan and Kristen B. Slaoui. The new directors will receive compensation in line with the company’s non-employee director compensation program and are granted stock options with vesting conditions tied to their continued service.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
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.