uniQure (NASDAQ:QURE) Posts Earnings Results, Beats Estimates By $0.04 EPS

Key Points

• uniQure reported a quarterly loss of $0.88 per share, beating estimates of a $0.92 loss, while revenue of $5.2 million fell short of the $6.17 million consensus.
• The FDA accepted uniQure’s AMT-130 application for Priority Review, with a target decision date of May 1, 2027; approval is not assured. The company plans a 200-patient confirmatory study, with screening expected to begin by year-end.
• Cash, cash equivalents and investments totaled $768.4 million at quarter-end, which management expects to fund operations into 2030.

uniQure (NASDAQ:QURE - Get Free Report) issued its earnings results on Wednesday. The biotechnology company reported ($0.88) EPS for the quarter, beating analysts' consensus estimates of ($0.92) by $0.04, FiscalAI reports. uniQure had a negative net margin of 1,350.73% and a negative return on equity of 111.96%. The business had revenue of $5.20 million for the quarter, compared to the consensus estimate of $6.17 million.

Here are the key takeaways from uniQure's conference call:

• The FDA accepted uniQure’s BLA for AMT-130 and granted Priority Review, setting a target decision date of May 1, 2027; the U.K. regulator also validated the company’s marketing application. The FDA is tentatively planning an advisory committee discussion, but approval is not assured.
• Management highlighted prior AMT-130 results showing a reported 75% slowing of disease progression on cUHDRS and 60% on Total Functional Capacity at 36 months versus a matched external control. The company also cited follow-up through 48 months, while noting the evidence comes from a small number of patients.
• The planned confirmatory study will enroll about 200 patients, randomize them 2:1 to AMT-130 or standard of care, and assess TFC at 36 months; screening is expected to begin by year-end. UniQure says it is preparing to have the study well underway by a potential approval, while planning for possible control-arm dropouts and global recruitment.
• Launch preparations are focused on specialist centers, with the company targeting more than 15 operational centers at launch but not yet specifying patient capacity. Management identified center readiness, institutional approvals and payer access as potential factors affecting how quickly patients could receive treatment.
• Cash, cash equivalents and investments totaled $768.4 million at quarter-end, and management expects funding to last into 2030. SG&A increased year over year amid hiring and launch preparations; separately, the company expects updated AMT-260 epilepsy and AMT-191 Fabry data in the first half of 2027.

uniQure Stock Down 4.6%

QURE traded down $1.10 during trading on Wednesday, hitting $22.77. The company had a trading volume of 1,965,984 shares, compared to its average volume of 2,411,165. The company has a market cap of $1.58 billion, a PE ratio of -5.72 and a beta of 1.14. The business has a 50-day moving average of $33.57 and a 200-day moving average of $29.69. The company has a debt-to-equity ratio of 0.15, a current ratio of 10.01 and a quick ratio of 10.01. uniQure has a 1-year low of $8.73 and a 1-year high of $51.72.

Analysts Set New Price Targets

QURE has been the subject of several recent research reports. UBS Group started coverage on uniQure in a report on Thursday, October 15th. They issued a "buy" rating and a $48.00 price target for the company. Stifel Nicolaus set a $71.00 price objective on uniQure in a research note on Wednesday. William Blair raised uniQure to a "strong-buy" rating in a research report on Wednesday, September 23rd. Royal Bank Of Canada lowered their target price on uniQure from $65.00 to $48.00 and set an "outperform" rating for the company in a research note on Friday, October 2nd. Finally, Barclays downgraded uniQure from an "overweight" rating to an "equal weight" rating and dropped their target price for the company from $60.00 to $28.00 in a report on Monday, October 5th. One analyst has rated the stock with a Strong Buy rating, eleven have issued a Buy rating, three have issued a Hold rating and one has assigned a Sell rating to the company. According to MarketBeat, uniQure has an average rating of "Moderate Buy" and an average target price of $56.83.

About uniQure

uniQure N.V. is a biotechnology company focused on developing gene therapies for serious and life-threatening diseases. The company uses adeno-associated virus (AAV) vectors and other genetic medicine technologies to deliver therapeutic genes intended to address the underlying causes of disease.

uniQure's best-known product is HEMGENIX, a gene therapy for adults with hemophilia B caused by factor IX deficiency. HEMGENIX was developed by uniQure and is commercialized by CSL Behring under a global licensing agreement.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.