tiprankstipranks
Trending News
More News >
uniQure N.V. (QURE)
:QURE
Advertisement

uniQure (QURE) AI Stock Analysis

Compare
1,173 Followers

Top Page

QURE

uniQure

(NASDAQ:QURE)

Rating:54Neutral
Price Target:
$16.00
▼(-2.02% Downside)
uniQure's overall stock score reflects significant financial challenges, including declining revenues and a weak balance sheet, which are the most impactful factors. While technical analysis shows positive momentum and recent corporate events provide strategic opportunities, the negative valuation metrics and mixed earnings call sentiment temper the overall outlook.
Positive Factors
Clinical Advancements
UniQure delivered a clean and focused update, with regulatory, manufacturing, and clinical progress keeping AMT-130 on track for a Biologics License Application filing and potential approval.
Regulatory Progress
FDA alignment and CMC progress keep AMT-130 on track for accelerated approval.
Therapy Development
AMT-130 is well-positioned as the first potential disease-modifying treatment for Huntington's disease.
Negative Factors
Leadership Changes
The announcement of Dr. Prasad as the head of CBER put pressure on the stock due to his outspoken views on accelerated approval and gene therapy.
Market Pressure
Several gene therapy programs have recently received clinical holds or complete response letters, which has placed some pressure on QURE shares.
Regulatory Uncertainty
The stock has been volatile due to regulatory uncertainty and has remained range-bound.

uniQure (QURE) vs. SPDR S&P 500 ETF (SPY)

uniQure Business Overview & Revenue Model

Company DescriptionuniQure N.V. is a leading gene therapy company focused on delivering transformative therapies for patients with severe diseases. The company specializes in developing innovative gene therapies for genetic disorders, particularly in the areas of hemophilia, Huntington's disease, and other neurodegenerative diseases. uniQure's proprietary AAV (adeno-associated virus) technology platform enables the development of durable gene therapies that aim to provide long-lasting treatment solutions.
How the Company Makes MoneyuniQure generates revenue primarily through the commercialization of its gene therapy products, which include marketed products like Zynteglo for beta-thalassemia and other pipeline therapies in late-stage clinical development. The company also earns revenue from research collaborations and licensing agreements with pharmaceutical and biotechnology companies. These partnerships may include upfront payments, milestone payments based on the achievement of specific developmental or regulatory goals, and royalties on future sales of licensed products. Additionally, uniQure may benefit financially from government grants and funding aimed at supporting innovative research in gene therapy.

uniQure Key Performance Indicators (KPIs)

Any
Any
Revenue by Segment
Revenue by Segment
Highlights income from different business areas, offering insight into which segments drive growth and profitability, and where there might be opportunities or challenges.
Chart InsightsuniQure's revenue from license agreements is showing a gradual recovery, while contract manufacturing revenue has sharply declined to zero in recent quarters. This aligns with the earnings call, which highlighted a significant drop in overall revenue due to reduced collaboration and contract manufacturing. Despite these challenges, uniQure's strong financial position and promising clinical advancements, particularly with AMT-130 for Huntington's disease, suggest a strategic pivot towards high-impact therapeutic developments, potentially offsetting revenue declines in other segments.
Data provided by:Main Street Data

uniQure Earnings Call Summary

Earnings Call Date:Jul 29, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Oct 29, 2025
Earnings Call Sentiment Neutral
The earnings call highlighted significant regulatory and clinical advancements, particularly with AMT-130 and AMT-260, and a strong financial position. However, these positives were tempered by a notable decline in revenue and increased R&D expenses.
Q2-2025 Updates
Positive Updates
Regulatory Progress for AMT-130
AMT-130 received breakthrough therapy designation from the FDA and achieved alignment on statistical analysis and CMC requirements for a BLA submission in early 2026.
Significant Clinical Advances
The company reported a 92% reduction in seizure frequency with AMT-260 for epilepsy and is on track for pivotal data releases for both AMT-130 and AMT-191 in Fabry disease.
Strong Financial Position
uniQure's cash, cash equivalents, and investment securities totaled $377 million as of June 30, 2025, providing funding into the second half of 2027.
Negative Updates
Revenue Decline
Total revenue for Q2 2025 was $5.3 million, a decrease from $11.1 million in the same period of 2024, primarily due to decreases in collaboration and contract manufacturing revenues.
Research and Development Expenses
R&D expenses increased to $35.4 million, up from $33.7 million in the same period of 2024, due to higher external program spend and increased fair value of contingent consideration.
Company Guidance
During the second quarter of 2025 earnings call, uniQure provided detailed guidance on their ongoing clinical advancements and regulatory progress, with a particular focus on AMT-130, a potential first disease-modifying therapy for Huntington's disease. Key metrics shared included the breakthrough therapy designation granted by the FDA in April, alignment with the FDA on the statistical analysis plan and CMC requirements, and the planned BLA submission in Q1 2026. The primary efficacy analysis will use a 3-year change in cUHDRS comparing high-dose patients to a propensity score matched external control. The company also reported an ongoing PPQ campaign and commercial launch preparations for 2026. Revenue for Q2 2025 was $5.3 million, a decrease from $11.1 million in the same period in 2024, with research and development expenses at $35.4 million. Cash, cash equivalents, and investment securities totaled $377 million as of June 30, 2025, positioning the company well for its planned commercialization efforts.

uniQure Financial Statement Overview

Summary
uniQure is facing significant financial challenges with declining revenues, negative profit margins, and a weak balance sheet. The company's high debt levels and negative equity position raise concerns about its financial stability. While there is a slight improvement in free cash flow, the overall financial health of the company is precarious, requiring strategic interventions to improve profitability and strengthen the balance sheet.
Income Statement
30
Negative
uniQure's income statement reflects significant challenges with declining revenues and negative profit margins. The TTM data shows a sharp revenue decline of 29% and a net profit margin of -13.88%, indicating substantial losses. Despite a high gross profit margin of 82.61% in the TTM, the company struggles with negative EBIT and EBITDA margins, highlighting operational inefficiencies.
Balance Sheet
25
Negative
The balance sheet reveals a concerning financial position with negative stockholders' equity and a high debt-to-equity ratio of -16.66 in the TTM. This indicates financial instability and potential solvency issues. The return on equity is also negative, reflecting ongoing losses and poor returns for shareholders.
Cash Flow
35
Negative
uniQure's cash flow statement shows a slight improvement in free cash flow growth at 4.33% in the TTM, but the operating cash flow remains negative, indicating cash burn. The free cash flow to net income ratio is slightly above 1, suggesting that the company is generating enough cash to cover its net losses, but the overall cash flow situation remains weak.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue14.34M27.12M15.84M106.48M524.00M37.51M
Gross Profit11.84M8.79M2.21M103.14M499.03M-84.89M
EBITDA-145.35M-160.75M-253.10M-108.02M319.00M-126.97M
Net Income-199.00M-239.56M-308.48M-126.79M329.59M-125.02M
Balance Sheet
Total Assets584.89M556.54M831.69M704.96M809.18M340.39M
Cash, Cash Equivalents and Short-Term Investments376.97M367.52M617.89M352.84M556.26M244.93M
Total Debt66.70M66.06M138.41M142.89M135.72M71.54M
Total Liabilities588.89M563.29M624.02M228.96M213.40M96.49M
Stockholders Equity-4.00M-6.75M207.67M476.01M595.78M243.91M
Cash Flow
Free Cash Flow-174.26M-186.10M-153.08M-162.75M270.52M-144.31M
Operating Cash Flow-173.44M-182.73M-145.93M-145.06M287.96M-134.83M
Investing Cash Flow114.22M162.97M-205.69M-182.73M-67.39M-9.48M
Financing Cash Flow21.18M-59.49M362.72M1.45M94.86M7.44M

uniQure Technical Analysis

Technical Analysis Sentiment
Positive
Last Price16.33
Price Trends
50DMA
14.66
Positive
100DMA
14.20
Positive
200DMA
13.43
Positive
Market Momentum
MACD
0.44
Negative
RSI
63.97
Neutral
STOCH
71.56
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For QURE, the sentiment is Positive. The current price of 16.33 is above the 20-day moving average (MA) of 15.02, above the 50-day MA of 14.66, and above the 200-day MA of 13.43, indicating a bullish trend. The MACD of 0.44 indicates Negative momentum. The RSI at 63.97 is Neutral, neither overbought nor oversold. The STOCH value of 71.56 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for QURE.

uniQure Risk Analysis

uniQure disclosed 65 risk factors in its most recent earnings report. uniQure 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

uniQure Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
74
Outperform
$1.21B5.9134.46%799.36%
55
Neutral
$1.22B-56.95%14.99%14.42%
54
Neutral
$895.98M-427.47%-48.25%33.77%
51
Neutral
$7.86B-0.26-41.41%2.22%22.87%-2.01%
50
Neutral
$769.26M-24.75%2190.50%52.85%
43
Neutral
$996.01M2.31-41.00%-429.68%
40
Underperform
$353.92M-69.65%10.36%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
QURE
uniQure
16.33
10.76
193.18%
RCKT
Rocket Pharmaceuticals
3.28
-14.72
-81.78%
SYRE
Spyre Therapeutics
16.49
-10.11
-38.01%
NTLA
Intellia Therapeutics
11.36
-10.26
-47.46%
CVAC
CureVac
5.37
2.31
75.49%
DAWN
Day One Biopharmaceuticals
7.51
-5.99
-44.37%

uniQure Corporate Events

Private Placements and FinancingBusiness Operations and Strategy
uniQure Announces $200 Million Sales Agreement
Positive
Jul 29, 2025

On July 29, 2025, uniQure N.V. announced a sales agreement with Leerink Partners LLC for an at-the-market offering program, allowing the company to sell its ordinary shares worth up to $200 million. This strategic move provides uniQure with flexibility in raising capital, potentially enhancing its financial position and supporting its ongoing operations in the competitive gene therapy market.

Executive/Board ChangesShareholder Meetings
uniQure Shareholders Approve Key Proposals at Annual Meeting
Neutral
Jun 13, 2025

On June 11, 2025, uniQure held its Annual Meeting where shareholders voted on several key proposals. The meeting resulted in the re-election of Matthew Kapusta as executive director and Dr. Robert Gut and Dr. Jeremy Springhorn as non-executive directors, each to serve until the 2028 annual general meeting. Additionally, all other proposals, including the adoption of the 2024 Dutch statutory annual accounts, discharge of board members’ liabilities, and various authorizations related to shares and compensation, were approved.

Product-Related AnnouncementsBusiness Operations and StrategyRegulatory Filings and Compliance
uniQure Aligns with FDA for AMT-130 BLA Approval
Positive
Jun 2, 2025

On June 2, 2025, uniQure announced alignment with the FDA on key components necessary for a Biologics License Application (BLA) for AMT-130, a gene therapy for Huntington’s disease. This alignment supports an accelerated approval pathway, with a BLA submission planned for early 2026. The company is leveraging extensive clinical data and FDA guidance to pursue the first disease-modifying treatment for Huntington’s disease, reflecting a significant step forward in addressing this unmet medical need.

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.Date of analysis: Aug 22, 2025