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Sep 30, 2023
uniQure Q3 2023 Earnings Report
uniQure announced its Q3 2023 financial results, highlighting FDA clearance of IND application for AMT-260, progress in clinical trials for AMT-130, and a strategic reorganization for cost savings.
Key Takeaways
uniQure reported Q3 2023 revenues of $1.4 million, consistent with the previous year. The company experienced a net loss of $89.6 million, compared to a $47.9 million loss in the same period of 2022. They announced FDA clearance for AMT-260 and are on track to provide a clinical update on AMT-130. A strategic reorganization is expected to save $180 million over three years, with a strong cash position of approximately $660 million.
Received FDA clearance for Investigational New Drug application for AMT-260 in refractory mesial temporal lobe epilepsy.
On track to provide a clinical update from U.S. and European Phase I/II trials of AMT-130 in Huntington’s disease later in the fourth quarter of 2023.
uniQure and CSL won the 2023 Prix Galien USA award for HEMGENIX®.
Announced a strategic reorganization expected to deliver $180 million of cost savings over the next three years.
uniQure
uniQure
Forward Guidance
uniQure expects continued progress on HEMGENIX® commercialization, plans to announce follow-up data from AMT-130 trials, aims to submit an IND for AMT-191, and anticipates initiating patient screening for AMT-162 and AMT-260.
Positive Outlook
- Continued progress on the commercialization of HEMGENIX®
- Plans to announce follow up data from the U.S. and European Phase I/II clinical study of AMT-130 in 2023
- Expectation to submit an investigational new drug application for AMT-191 in Fabry disease in 2023 and begin patient dosing in 2024
- Expectation to initiate patient screening in AMT-162 and AMT-260 in the fourth quarter of 2023
- Begin patient dosing in each in the first quarter of 2024
Challenges Ahead
- Risks associated with the regulatory approval and commercial launch of HEMGENIX®
- Material changes to our interim or preliminary data
- Impact of financial and geopolitical events on our Company and the wider economy and health care system
- Company’s ability to raise additional capital to support late stage development of the Company’s clinical program(s) if supported by future data
- Risks, uncertainties and other factors described under the heading "Risk Factors" in the Company’s periodic securities filings