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uniQure N.V. (QURE)
:QURE
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uniQure (QURE) AI Stock Analysis

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uniQure

(NASDAQ:QURE)

Rating:50Neutral
Price Target:
$14.50
▼(-3.27%Downside)
uniQure's stock score reflects significant financial challenges with persistent losses and a weakened balance sheet. However, positive regulatory developments for AMT-130 and a strong cash position provide some optimism. Valuation remains a concern due to negative earnings, while technical indicators suggest stabilization.
Positive Factors
Clinical Development
High-dose AMT-130 showed an 80% reduction of disease progression based on cUHDRS versus external control datasets.
Manufacturing Process
QURE will be able to use experience and knowledge from the Hemgenix manufacturing process to support their CMC requirements, which will expedite BLA filing.
Regulatory Approval
Reaching alignment with the FDA is seen as a very important de-risking event for QURE and further clarity on the content and timing of the BLA submission should bring investors some comfort.
Negative Factors
Leadership Changes
QURE is encouraged by the fact that the alignment with the FDA is consistent with previous communications from the company, despite some nervousness due to the appointment of Dr. Vinay Prasad as CBER Director.
Regulatory Challenges
Some investors might see the change here as a red flag, it's also very possible that QURE proposed the use of ENROLL-HD because they think it gives them the best shot.

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

uniQure Business Overview & Revenue Model

Company DescriptionuniQure N.V., a gene therapy company, engages in the development of treatments for patients suffering from genetic and other devastating diseases. Its lead program is Etranacogene dezaparvovec (AMT-061), which is in Phase III HOPE-B pivotal trial for the treatment of hemophilia B. The company also engages in developing AMT-130, a gene therapy that is in Phase I/II clinical study for the treatment of Huntington's disease; AMT-060, which is in Phase I/II clinical trial for the treatment of hemophilia B; AMT-210, a product candidate for the treatment of Parkinson's disease; AMT-260 for temporal lobe epilepsy; AMT-240, a preclinical product candidate for the treatment of autosomal dominant Alzheimer's disease; and AMT-161 for the treatment of amyotrophic lateral sclerosis. uniQure N.V. was founded in 1998 and is headquartered in Amsterdam, the Netherlands.
How the Company Makes MoneyuniQure generates revenue primarily through the development and commercialization of gene therapy products. The company earns money through collaborations and licensing agreements with pharmaceutical companies, which often involve upfront payments, milestone payments, and royalties on future sales of products developed with its technology. uniQure also aims to earn revenue from the direct sale of its gene therapy products once they achieve regulatory approval and enter the market. Partnerships with larger pharmaceutical companies can significantly impact its earnings by providing financial resources and sharing the risks associated with drug development.

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 has experienced significant volatility, with sharp declines in collaboration and contract manufacturing revenues leading to a notable drop in Q1 2025. Despite this, the company is strategically positioned with a strong cash reserve and reduced expenses, allowing it to focus on advancing its gene therapy pipeline. The breakthrough therapy designation for AMT-130 and ongoing clinical trials highlight potential future growth, although current revenue challenges and adverse events in trials present risks. Investors should watch for regulatory updates and initial data from upcoming trials as potential catalysts.
Data provided by:Main Street Data

uniQure Earnings Call Summary

Earnings Call Date:May 09, 2025
(Q1-2025)
|
% Change Since: 22.37%|
Next Earnings Date:Jul 31, 2025
Earnings Call Sentiment Neutral
The earnings call presented a balanced view with significant progress in regulatory and clinical advancements, particularly with AMT-130, and a strong financial position. However, the declines in revenue and immunosuppression-related adverse events were noted as challenges.
Q1-2025 Updates
Positive Updates
AMT-130 Regulatory Progress
AMT-130 received breakthrough therapy designation from the FDA in April and is on track for a planned BLA submission. The company has had multiple productive interactions with the FDA, focusing on preparing for this submission.
Pipeline Expansion
uniQure expanded its clinical pipeline with the initiation of three additional clinical studies in refractory temporal lobe epilepsy, Fabry disease, and SOD1-ALS.
Strong Financial Position
uniQure has more than $400 million in cash as of March 31, 2025, providing financial flexibility to advance its pipeline, including the planned BLA submission and launch of AMT-130.
Reduced Expenses
Research and development expenses decreased to $36.1 million from $40.7 million year-over-year, and selling, general, and administrative expenses decreased to $10.9 million from $13.9 million in the same period in 2024.
Negative Updates
Revenue Decline
Revenue for Q1 2025 was $1.6 million compared to $8.5 million in the same period in 2024, due to a decrease in collaboration and contract manufacturing revenues.
Immunosuppression-Related Adverse Events
In Cohort 3, three serious adverse events related to immunosuppression were observed, including mania, MRSA infection, and fever, although all were resolved with standard care.
Company Guidance
During the uniQure First Quarter 2025 Earnings Conference Call, CEO Matt Kapusta highlighted several key metrics and guidance for the year. The company is advancing its gene therapy pipeline with four clinical stage programs, notably AMT-130 for Huntington's disease, which is on track for a BLA submission. The FDA granted AMT-130 breakthrough therapy designation, and productive interactions with the FDA have occurred, with a detailed regulatory update expected later this quarter. In terms of financials, uniQure holds over $400 million in cash as of March 31, 2025, after a $80 million follow-on offering, providing the financial flexibility to support ongoing programs. The company reduced its cash burn rate through strategic divestitures and restructuring, and its operations are funded into the second half of 2027. Additionally, the Phase 1/2 trials for refractory temporal lobe epilepsy, Fabry disease, and SOD1-ALS are progressing, with initial data from Fabry expected in the second half of 2025.

uniQure Financial Statement Overview

Summary
uniQure's financial performance is concerning with significant revenue volatility, persistent losses, and a negative equity position indicating potential insolvency risks. Although there is some positive cash flow from investing activities, ongoing cash burn and financial instability highlight the need for strategic restructuring and revenue growth.
Income Statement
35
Negative
uniQure's income statement shows significant volatility in revenue and profitability. The company experienced a dramatic revenue decline from 2021 to 2023, with a slight recovery in 2024. Gross profit margin is low, and net profit margins are negative, indicating ongoing losses. The EBIT and EBITDA margins are also negative, reflecting operational challenges.
Balance Sheet
40
Negative
The balance sheet reveals a concerning financial structure with negative stockholders' equity in 2024, indicating potential insolvency risks. The debt-to-equity ratio is not calculable due to negative equity, but the company has managed to maintain a reasonable cash position. The equity ratio has deteriorated significantly, highlighting financial instability.
Cash Flow
45
Neutral
Cash flow analysis shows negative free cash flow and operating cash flow, indicating cash burn issues. The free cash flow to net income ratio is negative, which is concerning. However, the company has managed to generate positive cash flow from investing activities in 2024, providing some liquidity relief.
BreakdownDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue27.12M15.84M106.48M524.00M37.51M
Gross Profit8.79M2.21M103.14M499.03M-84.89M
EBITDA-160.75M-253.10M-108.02M319.00M-126.97M
Net Income-239.56M-308.48M-126.79M329.59M-125.02M
Balance Sheet
Total Assets556.54M831.69M704.96M809.18M340.39M
Cash, Cash Equivalents and Short-Term Investments367.52M617.89M352.84M556.26M244.93M
Total Debt66.06M138.41M142.89M135.72M71.54M
Total Liabilities563.29M624.02M228.96M213.40M96.49M
Stockholders Equity-6.75M207.67M476.01M595.78M243.91M
Cash Flow
Free Cash Flow-186.10M-153.08M-162.75M270.52M-144.31M
Operating Cash Flow-182.73M-145.93M-145.06M287.96M-134.83M
Investing Cash Flow162.97M-205.69M-182.73M-67.39M-9.48M
Financing Cash Flow-59.49M362.72M1.45M94.86M7.44M

uniQure Technical Analysis

Technical Analysis Sentiment
Positive
Last Price14.99
Price Trends
50DMA
14.56
Positive
100DMA
13.44
Positive
200DMA
12.11
Positive
Market Momentum
MACD
0.02
Negative
RSI
54.28
Neutral
STOCH
63.10
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 14.99 is above the 20-day moving average (MA) of 14.37, above the 50-day MA of 14.56, and above the 200-day MA of 12.11, indicating a bullish trend. The MACD of 0.02 indicates Negative momentum. The RSI at 54.28 is Neutral, neither overbought nor oversold. The STOCH value of 63.10 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 (52)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
76
Outperform
$1.21B5.9434.46%799.36%
60
Neutral
$1.25B-57.92%-13.37%2.57%
52
Neutral
$7.35B-0.07-63.71%2.36%16.17%0.03%
50
Neutral
$820.68M-241.16%6.30%29.17%
50
Neutral
$648.72M-17.80%56.10%
43
Neutral
$983.16M2.31-50.47%-100.00%94.68%
40
Underperform
$327.52M-60.45%6.99%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
QURE
uniQure
14.99
7.37
96.72%
RCKT
Rocket Pharmaceuticals
3.04
-21.04
-87.38%
SYRE
Spyre Therapeutics
16.29
-14.49
-47.08%
NTLA
Intellia Therapeutics
12.06
-13.27
-52.39%
CVAC
CureVac
5.39
1.60
42.22%
DAWN
Day One Biopharmaceuticals
6.40
-8.47
-56.96%

uniQure Corporate Events

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.

The most recent analyst rating on (QURE) stock is a Buy with a $20.00 price target. To see the full list of analyst forecasts on uniQure stock, see the QURE Stock Forecast page.

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.

The most recent analyst rating on (QURE) stock is a Buy with a $20.00 price target. To see the full list of analyst forecasts on uniQure stock, see the QURE Stock Forecast page.

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: Jul 17, 2025