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Achieve Life Sciences Inc (ACHV)
NASDAQ:ACHV
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Achieve Life Sciences
(NASDAQ:ACHV)
37Underperform
Positive Factors
Commercial Strategy
The planned digital-forward, partnered commercial strategy is focused on reaching high decile primary care physicians and one-quarter of the smoking population that is actively seeking to quit.
Market Potential
ACHV expects that cytisinicline could generate significant net sales in the U.S. for smoking cessation.
Regulatory Progress
A successful outcome was achieved at the end-of-Phase 2 meeting with the FDA, aligning on a single P3 study to support a future supplemental NDA for vaping cessation.
Negative Factors
Financing Delay
The Company announced it intends to delay the initiation of its financing-dependent Phase 3 registrational study in vaping cessation to 1H26 from 3Q25.
Study Timing
The delay in the Phase 3 registrational study for vaping cessation could slow the overall timeline for product availability.
Achieve Life Sciences (ACHV) vs. S&P 500 (SPY)
Market Cap
$77.17M
Dividend YieldN/A
Average Volume (3M)185.47K
Price to Earnings (P/E)―
Beta (1Y)1.21
Revenue GrowthN/A
EPS Growth19.70%
CountryUS
Employees25
SectorHealthcare
Sector Strength78
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.23
Shares Outstanding34,685,074
10 Day Avg. Volume207,256
30 Day Avg. Volume185,475
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
Price to Cash Flow (P/CF)-2.70
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$13.67Price Target Upside590.40% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering3
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 typical challenges for early-stage biotech firms, with no revenue and significant losses. Although there is an improvement in equity and financing inflows, the company is in a precarious 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 |
| 0.00 | -27.25M | -40.80M | -33.09M | -14.75M | EBITDA |
| 0.00 | -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
Negative
1.98
Price Trends
2.96
Negative
3.43
Negative
4.06
Negative
Market Momentum
-0.10
Positive
35.98
Neutral
17.71
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ACHV, the sentiment is Negative. The current price of 1.98 is below the 20-day moving average (MA) of 2.65, below the 50-day MA of 2.96, and below the 200-day MA of 4.06, indicating a bearish trend. The MACD of -0.10 indicates Positive momentum. The RSI at 35.98 is Neutral, neither overbought nor oversold. The STOCH value of 17.71 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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 0 New Risks
Achieve Life Sciences Peers Comparison
Overall Rating
UnderperformOutperform
Sector (48)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
49 Neutral | $71.00M | ― | -114.71% | ― | 288.94% | 39.45% | |
49 Neutral | $80.17M | ― | -58.80% | ― | -100.00% | -24.28% | |
48 Neutral | $6.27B | 1.17 | -48.19% | 2.68% | 17.28% | 1.24% | |
42 Neutral | $104.21M | ― | -54.21% | ― | -78.55% | -0.92% | |
42 Neutral | $80.30M | ― | -76.26% | ― | -72.22% | 51.95% | |
39 Underperform | $84.55M | ― | -337.30% | ― | 45.30% | 45.67% | |
37 Underperform | $77.17M | ― | -409.51% | ― | ― | 19.70% |
* Healthcare Sector Average
Performance Comparison
ACHV
Achieve Life Sciences
1.98
-2.40
-54.79%
FATE
Fate Therapeutics
0.90
-5.37
-85.65%
VXRT
Vaxart
0.31
-0.70
-69.31%
ADVM
Adverum Biotechnologies
3.40
-8.58
-71.62%
ANIX
Anixa Biosciences
2.38
-0.82
-25.63%
BDSX
Biodesix
0.59
-0.64
-52.03%
Achieve Life Sciences Earnings Call Summary
Earnings Call Date: Mar 11, 2025 | % Change Since: -35.29% | Next Earnings Date: May 8, 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.Highlights
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.
Lowlights
Challenges in Vaping Cessation
The initiation of the Phase 3 ORCA-V2 clinical trial for vaping cessation is dependent on financing, which could delay progress.
High Operating Expenses
Total operating expenses for the fourth quarter and year ended December 31, 2024, were $12.2 million and $39.1 million, respectively, contributing to a net loss of $12.4 million for the fourth quarter.
Dependence on FDA Approval
The commercial launch and financial future heavily depend on the successful submission and approval of the NDA, with potential delays in the process posing a risk.
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.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.