uniQure (QURE) AI Stock Analysis

• Market Cap: $1.35B
• Dividend Yield: N/A
• Average Volume (3M): 3.09M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.12
• Revenue Growth: -44.90%
• EPS Growth: 11.49%
• Country: US
• Employees: 209
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -1.38
• Shares Outstanding: 61,603,770
• 10 Day Avg. Volume: 3,619,677
• 30 Day Avg. Volume: 3,089,742
• PEG Ratio: 0.15
• Price to Book (P/B): -127.24
• Price to Sales (P/S): 31.68
• P/FCF Ratio: -4.62
• Enterprise Value/Market Cap: 2.41
• Enterprise Value/Revenue: 206.53
• Enterprise Value/Gross Profit: 234.35
• Enterprise Value/Ebitda: -22.24
• 1Y Price Target: $57.40
• Price Target Upside: 149.24% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 12
• EPS Forecast (FY): -3.84
• Revenue Forecast (FY): $16.28M

• Rating: 41 Neutral
• Price Target: $21.00 ▼(-8.81% Downside)

uniQure's overall stock score is primarily impacted by its financial performance and technical analysis, both of which indicate significant challenges. The company's negative profitability and bearish technical indicators weigh heavily on the score. The earnings call provides some optimism with advancements in the therapeutic pipeline, but regulatory setbacks and increased costs remain concerns.

Positive Factors

Pipeline Advancements

The significant slowing of disease progression in Huntington's disease indicates strong potential for AMT-130, enhancing uniQure's pipeline credibility and market position in gene therapies.

Financial Position

A robust cash position provides uniQure with financial flexibility to fund ongoing R&D and operational needs, supporting long-term strategic initiatives and stability.

Therapeutic Pipeline

Positive results in epilepsy expand uniQure's therapeutic pipeline, potentially opening new market opportunities and reinforcing its position in innovative gene therapies.

Negative Factors

Regulatory Challenges

The FDA's stance introduces uncertainty in the approval timeline for AMT-130, potentially delaying market entry and impacting revenue expectations from this key therapy.

Increased Expenses

Rising operational costs can strain profitability and cash flow, challenging uniQure's ability to maintain financial health without increasing revenue.

Program Pauses

Pausing the AMT-162 trial due to safety concerns could delay development timelines and reduce investor confidence in uniQure's ability to manage clinical risks.

uniQure Business Overview & Revenue Model

Company Description

uniQure N.V. is a leading gene therapy company based in the Netherlands, specializing in the development of innovative treatments for genetic diseases. The company focuses on advanced therapies for serious and life-threatening conditions, with a particular emphasis on hemophilia, and has developed a robust portfolio of gene therapies using its proprietary AAV (adeno-associated virus) platform. uniQure's core products include its approved gene therapy for hemophilia B and multiple product candidates in various stages of clinical development targeting other genetic disorders.

How the Company Makes Money

uniQure generates revenue primarily through the sale of its gene therapy products, with significant income derived from its approved treatment for hemophilia B. The company also earns revenue through partnerships and collaborations with other biopharmaceutical companies, which may involve upfront payments, milestone payments based on clinical and regulatory achievements, and royalties on sales of partnered products. Additionally, uniQure may receive funding from government grants or research initiatives aimed at advancing gene therapy technologies, which contribute to its overall financial performance.

uniQure Financial Statement Overview

Summary

uniQure faces significant financial challenges, particularly in achieving profitability and positive cash flow. Despite revenue growth, high operating costs prevent net profits. The balance sheet shows some improvement in equity, but the company struggles with negative cash flow and return on equity.

Income Statement

uniQure's income statement shows significant challenges with profitability, as evidenced by negative net profit margins and EBIT margins over the TTM period. Despite a modest revenue growth rate of 9.86% in the TTM, the company has struggled to convert this into profit, with a net profit margin of -14.93%. The gross profit margin is relatively strong at 88.13%, indicating effective cost management at the gross level, but high operating expenses are impacting overall profitability.

Balance Sheet

The balance sheet reflects a moderate debt-to-equity ratio of 0.29, suggesting manageable leverage levels. However, the return on equity is significantly negative at -373.73%, indicating that the company is not generating returns on shareholder equity. The equity ratio is not directly provided, but the company's equity position has improved from negative to positive, indicating some recovery in financial stability.

Cash Flow

Cash flow analysis reveals challenges with negative operating cash flow and free cash flow in the TTM. The free cash flow to net income ratio is slightly above 1, indicating that cash flow is somewhat aligned with net income, albeit both are negative. The free cash flow growth rate is negative, suggesting declining cash generation capabilities.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	15.75M	27.12M	15.84M	106.48M	524.00M	37.51M
Gross Profit	13.88M	8.79M	2.21M	103.14M	499.03M	-84.89M
EBITDA	-146.30M	-160.75M	-253.10M	-108.02M	319.00M	-126.97M
Net Income	-235.15M	-239.56M	-308.48M	-126.79M	329.59M	-125.02M
Balance Sheet
Total Assets	888.38M	556.54M	831.69M	704.96M	809.18M	340.39M
Cash, Cash Equivalents and Short-Term Investments	694.25M	367.52M	617.89M	352.84M	556.26M	244.93M
Total Debt	66.16M	66.06M	138.41M	142.89M	135.72M	71.54M
Total Liabilities	659.64M	563.29M	624.02M	228.96M	213.40M	96.49M
Stockholders Equity	228.75M	-6.75M	207.67M	476.01M	595.78M	243.91M
Cash Flow
Free Cash Flow	-153.62M	-186.10M	-153.08M	-162.75M	270.52M	-144.31M
Operating Cash Flow	-153.24M	-182.73M	-145.93M	-145.06M	287.96M	-134.83M
Investing Cash Flow	93.13M	162.97M	-205.69M	-182.73M	-67.39M	-9.48M
Financing Cash Flow	406.43M	-59.49M	362.72M	1.45M	94.86M	7.44M

uniQure Technical Analysis

• Technical Analysis Sentiment: Neutral
• Last Price: 23.03
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Positive
• MACD: Negative
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For QURE, the sentiment is Neutral. The current price of 23.03 is below the 20-day moving average (MA) of 24.16, below the 50-day MA of 39.50, and above the 200-day MA of 22.48, indicating a neutral trend. The MACD of -4.25 indicates Negative momentum. The RSI at 38.09 is Neutral, neither overbought nor oversold. The STOCH value of 43.74 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for QURE.

uniQure Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
IMNM	56 Neutral	$2.15B	-6.69	-93.04%	―	-4.44%	63.58%
BCRX	55 Neutral	$1.57B	-150.74	―	―	45.38%	92.85%
AMLX	52 Neutral	$1.35B	-6.60	-56.52%	―	-100.34%	52.85%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
AGIO	48 Neutral	$1.52B	-3.66	-27.57%	―	36.26%	-158.98%
PHVS	42 Neutral	$1.58B	―	-51.81%	―	―	-20.08%
QURE	41 Neutral	$1.35B	-5.25	-165.27%	―	-44.90%	11.49%

uniQure Corporate Events

uniQure Faces Setback in Gene Therapy Approval

On December 4, 2025, uniQure announced a regulatory update on its investigational gene therapy, AMT-130, for Huntington’s disease. Following a pre-Biologics License Application meeting with the FDA on October 29, 2025, the agency indicated that data from Phase I/II studies are unlikely to support a BLA submission. uniQure plans to urgently request a follow-up meeting with the FDA in early 2026 to address this feedback and advance the therapy for patients.

uniQure Faces FDA Setback on Huntington’s Therapy

On November 3, 2025, uniQure announced a regulatory update regarding its investigational gene therapy for Huntington’s disease, AMT-130, following a pre-Biologics License Application meeting with the FDA. The company revealed that the FDA no longer agrees that data from Phase I/II studies of AMT-130 in comparison to an external control may be adequate for a BLA submission, creating uncertainty around the timing of the submission. Despite this setback, uniQure is committed to working with the FDA and other regulatory bodies to find a path forward for AMT-130’s approval, emphasizing the therapy’s potential benefits for patients with Huntington’s disease.

uniQure Announces Positive Results for Huntington’s Study

On September 24, 2025, uniQure announced positive topline results from its pivotal Phase I/II study of AMT-130 for Huntington’s disease, demonstrating a statistically significant 75% slowing of disease progression at 36 months in high-dose patients, compared to a control group. The study met its primary endpoint and showed favorable trends in secondary endpoints, with AMT-130 being well-tolerated and no new serious adverse events reported since December 2022. The company plans to discuss these results with the FDA, aiming for a Biologic License Application submission in early 2026, potentially impacting the treatment landscape for Huntington’s disease.

uniQure Secures $175 Million Loan Amendment

On September 22, 2025, uniQure N.V. entered into an amendment with Hercules Capital to their existing loan agreement, allowing for an additional $175 million in term loans. This amendment is intended to refinance existing loans and support general corporate purposes, potentially impacting uniQure’s financial flexibility and operational capacity in the biotechnology sector.