uniQure(QURE)

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uniQure(QURE) - 2023 Q4 - Annual Report
2024-02-28 12:51
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36294 uniQure N.V. (Exact name of Registrant as specified in its charter) The Netherlands (Jurisdiction of incorpor ...
uniQure(QURE) - 2023 Q3 - Quarterly Report
2023-11-07 12:52
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 The Netherlands FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-36294 uniQure N.V. (Exact name of Registrant as specified in its charter) ...
uniQure(QURE) - 2023 Q2 - Quarterly Report
2023-08-01 11:37
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-36294 uniQure N.V. (Exact name of Registrant as specified in its charter) The Netherlands (Stat ...
uniQure(QURE) - 2023 Q1 - Quarterly Report
2023-05-09 11:20
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact name of Registrant as specified in its charter) Washington D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-36294 uniQure N.V. The Netherlands (Sta ...
uniQure (QURE) Investor Presentation - Slideshow
2023-03-10 13:28
Charles, Huntington's disease patient advocate LE A D E R S H IP IN GE N E T H E R A P Y LEADERSHIP IN GENE THERAPY MARCH 2023 MA R C H 2023 | 22 First approved AAV gene therapy First AAV vector demonstrated effective in patients with NABs MARCH 2023 a case study in delivering value through innovation 2017 Announced transition to AMT-061 2018 Initiated Ph 2b doseconfirmation study and HOPE-B pivotal study leading the gene therapy revolution • Broad pipeline of first/best-in-class gene therapies • EU approva ...
uniQure(QURE) - 2022 Q4 - Annual Report
2023-02-27 12:20
Financial Milestones - The company reported a significant milestone payment of $75.0 million from CSL Behring upon the first sale of HEMGENIXÔ in the European Union prior to July 2, 2023[14]. - The company may need to raise additional funding, which could be affected by a $75.0 million milestone payment related to HEMGENIXÔ sales in the EU[14]. Clinical Trials and Product Development - The company anticipates continued reliance on third parties for conducting clinical trials, which may impact timelines and regulatory compliance[14]. - The company has encountered delays in clinical trials and may continue to face challenges in demonstrating the safety and efficacy of its product candidates[14]. - The company may not successfully build a pipeline of additional product candidates using its gene therapy technology platform[14]. - The company is focused on building a pipeline of additional product candidates using its gene therapy technology platform[14]. - The company is reliant on third parties for conducting clinical trials, which may not perform satisfactorily or meet regulatory requirements[14]. Regulatory and Compliance Risks - The company is subject to significant government regulations regarding its manufacturing facility, and failure to comply could harm its business[14]. - The company must comply with complex data protection laws, and failure to do so may result in penalties[14]. - The company is exposed to risks associated with data protection laws across different jurisdictions, with potential penalties for non-compliance[14]. Operational Challenges - The ongoing Covid pandemic has materially affected the company's operations and supply chain[15]. - The ongoing Covid pandemic has materially affected the company's business, operations, and supply chain[15]. - The company faces risks related to competition, pricing, and reimbursement for its product candidates, which could adversely affect revenue[14]. - The company faces competition and challenges in employee recruitment and retention, which could adversely affect its business[14]. Internal Controls and Security - The company emphasizes the importance of maintaining effective internal controls to ensure accurate reporting and prevent fraud[15]. - The company’s internal computer systems may suffer security breaches or disruptions, impacting product development programs[14]. Funding and Intellectual Property - The company may need to raise additional funding, which may not be available on acceptable terms, potentially impacting product development efforts[14]. - The company relies on licenses of intellectual property from third parties, which may not be available in the future on commercially reasonable terms[14]. - The company relies on licenses of intellectual property from third parties, which may not be available on commercially reasonable terms[14].
uniQure(QURE) - 2022 Q3 - Quarterly Report
2022-11-02 11:45
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-36294 uniQure N.V. (Exact name of Registrant as specified in its charter) The Netherlands (State or other ju ...
uniQure(QURE) - 2022 Q2 - Quarterly Report
2022-08-08 12:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FORM 10-Q For the transition period from _______ to _______ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR Commission file number: 001-36294 uniQure N.V. (Exact name of Registrant as specified in its charter) The Netherlands (State or other jurisdi ...
uniQure(QURE) - 2022 Q1 - Quarterly Report
2022-05-02 11:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION uniQure N.V. (Exact name of Registrant as specified in its charter) Washington D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-36294 The Netherlands (State or other jurisd ...
uniQure(QURE) - 2021 Q4 - Annual Report
2022-02-25 12:36
COVID-19 Impact - The company reported a significant impact from the ongoing COVID-19 pandemic on its business and operations[16] - The ongoing Covid pandemic has materially and adversely affected the company's business, operations, and supply chain[16] Clinical Trials and Product Development - There are delays and challenges in the progress of clinical trials, which may affect the safety and efficacy demonstration of product candidates[16] - The company has encountered delays in clinical trials and may fail to demonstrate the safety and efficacy of its product candidates[16] - There is uncertainty regarding the successful commercialization of product candidates and potential delays could materially harm the business[16] - The company relies on third parties for clinical trials, which may not perform satisfactorily, impacting timelines and regulatory compliance[16] Regulatory Compliance - Regulatory compliance is critical for the manufacturing facility, and failure to maintain approvals could materially harm the business[16] - The company is subject to significant government regulations and approvals for its manufacturing facility, and failure to comply could materially harm the business[16] - Data protection laws in various jurisdictions pose compliance challenges, and failure to comply may result in penalties affecting the business[19] - The company faces potential penalties for non-compliance with data protection laws, which could adversely affect its financial condition[19] Funding and Financial Challenges - The company may need to raise additional funding, which could be challenging and affect product development efforts[16] - The company may need to raise additional funding, which may not be available on acceptable terms, potentially affecting product development efforts[16] Competition and Market Risks - The company is exposed to competition and pricing pressures that could adversely affect product revenue[16] - The company faces competition and challenges in recruiting and retaining employees, which could adversely affect its operations[16] Intellectual Property Risks - Intellectual property licensing from third parties may not be available on commercially reasonable terms, impacting product commercialization[16] - The company relies on licenses of intellectual property from third parties, which may not be available in the future on commercially reasonable terms[16] Internal Controls and Security - Internal control failures could lead to inaccurate reporting and negatively impact investor confidence and share price[19] - Internal computer systems may suffer security breaches or disruptions, potentially disrupting product development programs[19]