Achieve Life Sciences (ACHV) AI Stock Analysis

• Market Cap: $144.63M
• Dividend Yield: N/A
• Average Volume (3M): 1.16M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.46
• Revenue Growth: N/A
• EPS Growth: -32.50%
• Country: US
• Employees: 25
• Sector: Healthcare
• Sector Strength: 52
• Industry: Biotechnology
• EPS (TTM): -0.37
• Shares Outstanding: 51,104,970
• 10 Day Avg. Volume: 2,080,821
• 30 Day Avg. Volume: 1,163,437
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): N/A
• P/FCF Ratio: N/A
• Enterprise Value/Market Cap: 0.23
• Enterprise Value/Revenue: 144.52
• Enterprise Value/Gross Profit: -10.98K
• Enterprise Value/Ebitda: -0.67
• 1Y Price Target: $14.60
• Price Target Upside: 415.90% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 5

• Rating: 37 Underperform
• Price Target: ―

Achieve Life Sciences is navigating typical early-stage biotech challenges, including zero revenue and significant financial losses. While there are promising developments such as the upcoming NDA submission and strong clinical trial progress, these are offset by high operating expenses and dependency on future financing and regulatory approvals. Technical indicators reflect a downward trend, and the valuation remains unattractive with a negative P/E ratio.

Positive Factors

Market Potential

Cytisinicline has the potential to become the first FDA-approved nicotine addiction drug in almost 20 years, highlighting its unique market position.

Regulatory Approval

The FDA has accepted its NDA for its smoking cessation treatment, cytisinicline, with a PDUFA date set for 6/20/26.

Strategic Partnerships

A strategic partnership with Omnicom to co-develop and execute a fully integrated, AI-enabled US launch strategy for cytisinicline has been announced, pending FDA approval.

Negative Factors

Operational Costs

An increase in 2025 and 2026 expense estimates, suggesting higher operational costs for the company in the coming years.

Achieve Life Sciences Business Overview & Revenue Model

Company Description

Achieve 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 Money

Achieve 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.

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.

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.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	228.00K	0.00	0.00	0.00	0.00	0.00
Gross Profit	-3.00K	-229.00K	-228.00K	-236.00K	-250.00K	-255.00K
EBITDA	-49.25M	-37.42M	-26.73M	-40.33M	-32.90M	-14.47M
Net Income	-50.42M	-39.83M	-29.82M	-41.88M	-32.90M	-14.66M
Balance Sheet
Total Assets	58.94M	38.63M	19.37M	29.97M	47.52M	40.30M
Cash, Cash Equivalents and Short-Term Investments	55.40M	34.36M	15.55M	24.77M	43.02M	35.85M
Total Debt	9.96M	9.96M	16.73M	16.20M	73.00K	169.00K
Total Liabilities	17.27M	17.73M	20.82M	21.67M	19.47M	3.01M
Stockholders Equity	41.67M	20.90M	-1.45M	8.30M	28.04M	37.29M
Cash Flow
Free Cash Flow	-39.72M	-29.77M	-24.50M	-37.55M	-29.46M	-13.49M
Operating Cash Flow	-39.72M	-29.77M	-24.48M	-37.55M	-29.44M	-13.47M
Investing Cash Flow	43.04M	-21.58M	-21.00K	0.00	-17.00K	-17.00K
Financing Cash Flow	33.79M	48.53M	15.28M	19.30M	36.61M	32.68M

Achieve Life Sciences Technical Analysis

• Technical Analysis Sentiment: Neutral
• Last Price: 2.83
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Negative
• MACD: Positive
• RSI: Neutral
• STOCH: Positive

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 2.83 is above the 20-day moving average (MA) of 2.78, above the 50-day MA of 2.64, and below the 200-day MA of 3.08, indicating a neutral trend. The MACD of 0.07 indicates Positive momentum. The RSI at 50.85 is Neutral, neither overbought nor oversold. The STOCH value of 18.13 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for ACHV.

Achieve Life Sciences Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
CLLS	64 Neutral	$192.96M	―	-48.36%	―	333.74%	―
Sector *	51 Neutral	$7.95B	-0.40	-42.50%	2.21%	22.29%	-1.85%
SPRO	48 Neutral	$120.99M	10.83	-94.59%	―	-67.67%	-390.60%
IOBT	43 Neutral	$128.47M	―	-212.51%	―	―	-9.69%
NKTX	39 Underperform	$160.52M	―	-26.94%	―	―	26.33%
MIST	39 Underperform	$152.99M	―	-780.29%	―	―	20.13%
ACHV	37 Underperform	$144.63M	―	-120.11%	―	―	-32.50%

Achieve Life Sciences Corporate Events

Achieve Life Sciences Announces Board of Directors Changes

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.