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uniQure N.V. (MX:QUREN)
:QUREN
Mexico Market
EarningsQ2 2026 Earnings Report

uniQure (QUREN) Q2 2026 Earnings Report

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MX:QUREN Q2 2026 EPS Results

Actual EPS-$22.18
Consensus EPS-$14.94
Beat/MissMissed by -$7.23
One Year Ago EPS-$12.54

MX:QUREN Q2 2026 Revenue Results

Actual Revenue$106.18M
Expected Revenue$99.05M
Beat/MissBeat by +$7.13M
YoY Revenue Growth+11.00%

Earnings Announcement Details

QuarterQ2 2026
Date07/29/2026
TimeBefore Open
Conference CallWednesday, July 29, 2026
MX:QUREN Upcoming Earnings
uniQure's next earnings date is estimated for November 10, 2026, based on past reporting schedules.

Q2 2026 Earnings Call Audio

MX:QUREN Q2 2026 Earnings Call
0:00 / 0:00

Q2 2026 Earnings Slide Deck

No slide deck is available for this earnings event.

Q2 2026 Earnings Call Summary

Q2 2026
Earnings Call Date:Jul 29, 2026|
% Change Since:
|
Earnings Call Sentiment|Positive
Overall the call conveyed strong positive momentum: regulatory progress (FDA alignment on using 3-year data as the basis for an accelerated BLA), an on-track BLA/MAA submission timeline, upcoming 4-year AMT-130 data, encouraging early efficacy and biological signals in AMT-260 and AMT-191, and a materially strengthened balance sheet with ~$810M cash supporting operations into 2030. Notable challenges include a pause in higher-dose AMT-191 dosing after Grade 3 LFTs (dose-limiting toxicity), mixed early efficacy in the AMT-260 low-dose cohort, increased SG&A to fund commercialization (near-term burn), and the operational/regulatory requirement to have the confirmatory trial well underway at the time of any accelerated approval. Taken together, the positives (regulatory clarity, data momentum, cash runway, early signals) outweigh the manageable clinical and execution risks identified.
Company Guidance
The company provided clear near-term regulatory and programmatic guidance: uniQure is on track to submit a BLA for AMT‑130 in Q3 2026 (and an MAA to the MHRA in Q3), with the FDA agreeing that the 3‑year Phase I/II data can serve as the primary basis for accelerated approval but asking that the confirmatory randomized, standard‑of‑care‑controlled trial (with total functional capacity at 36 months as the proposed primary endpoint) be aligned and well underway—or potentially fully enrolled—around the time of approval; uniQure intends to initiate that global confirmatory study ASAP. Key data milestones include a June 30, 2026 data cutoff for the planned 4‑year AMT‑130 analysis to be presented in September (analysis to include 12 high‑ and 12 low‑dose patients at 4 years plus 3 additional high‑dose patients with 3‑year follow‑up, cUHDRS/TFC comparisons vs a ~26,000‑participant Enroll‑HD natural history pool, and CSF NfL change). For other programs, AMT‑260 low‑dose cohort data (May 29, 2026 cutoff) showed 3 of 6 patients with 79–100% reductions in disabling seizures in months 4–6 (others −33% to +36%), no related SAEs, and higher‑dose cohort enrollment expected to complete imminently with updates in H1 2027; AMT‑191 (March 15, 2026 cutoff) has 11 dosed patients across 3 dose levels with dose‑dependent alpha‑Gal A increases, stable plasma lyso‑Gb3, all 11 off ERT, but 2 Grade‑3 LFTs in the mid‑dose cohort confirmed as DLTs (resolved with immunosuppression by end‑May 2026) and mid/high dosing paused pending an FDA monitoring/management plan. Financially, Q2 revenue was $5.8M (vs. $5.3M YoY), R&D expense $34.0M (vs. $35.4M), SG&A $17.4M (vs. $13.5M), and cash/investments were $810.3M as of June 30, 2026 (up from $622.5M at 12/31/25), which the company expects to fund operations into 2030; AMT‑130 holds Breakthrough, RMAT and Fast Track designations and priority review will be requested at submission.
Regulatory alignment for AMT-130 and near-term submission timeline
FDA Type B meeting confirmed that the 3-year Phase I/II AMT-130 data are acceptable as the primary basis for a BLA under the accelerated approval pathway; company is on track to submit the BLA in Q3 2026 and expects a parallel MHRA (U.K.) submission in Q3 2026.
Confirmatory study design allowance (no sham required)
FDA agreed that the confirmatory study does not require a sham procedure and recommended a randomized standard-of-care controlled study with total functional capacity (TFC) at 36 months as primary endpoint, reducing one potential operational barrier to study conduct.
Upcoming 4-year AMT-130 clinical readout
Company expects to conduct 4-year AMT-130 data analyses based on a June 30 cutoff and present 4-year safety/tolerability and efficacy topline results in September 2026 (includes data from 12 high- and 12 low-dose patients at 4 years, plus 3 additional high-dose patients with 3 years follow-up).
Early encouraging data for AMT-260 (epilepsy)
Phase I/II low-dose cohort (n=6) showed 3 patients with meaningful reductions in disabling seizures (79% to 100% reduction months 4-6 vs baseline); no SAEs related to AMT-260 or the surgical procedure reported and adverse events were mild/moderate; higher-dose cohort enrollment expected to complete imminently.
Promising biological activity for AMT-191 (Fabry disease)
Across 11 dosed patients (three dose levels) AMT-191 produced dose-dependent increases in alpha-Gal A activity; plasma lyso-Gb3 levels remained stable and all 11 patients remained withdrawn from enzyme replacement therapy (ERT) at reported follow-up.
Strong balance sheet and extended runway
Cash, cash equivalents and investment securities were $810.3 million as of June 30, 2026 versus $622.5 million as of December 31, 2025 (increase of $187.8 million, ~30.2%); company expects funding sufficient to support operations into 2030, including confirmatory and commercial activities.
Revenue growth quarter-over-quarter
Revenue for Q2 2026 was $5.8 million versus $5.3 million in Q2 2025, an increase of $0.5 million (~9.4%), driven by higher license revenue.
R&D spend slightly reduced year-over-year
Research & development expenses were $34.0 million in Q2 2026 versus $35.4 million in Q2 2025, a decrease of $1.4 million (~4.0%), driven by lower facility, employee/contractor costs and contingent consideration changes, partially offset by higher direct spend on AMT-260, AMT-162 and AMT-191.

MX:QUREN Earnings History

Report Date
Fiscal Quarter
Forecast / EPS
Last Year's EPS
EPS YoY Change
Press Release
Nov 10, 2026
2026 (Q3)
-16.76 / -
-25.086―
2026 (Q2)
-14.94 / -22.18
-12.543-76.81% (-9.63)
2026 (Q1)
-15.72 / -15.45
-14.906-3.66% (-0.55)
2025 (Q4)
-16.61 / -10.36
-27.08561.74% (+16.72)
2025 (Q3)
-16.41 / -25.09
-16.542-51.65% (-8.54)
2025 (Q2)
-16.27 / -12.54
-21.08740.52% (+8.54)
2025 (Q1)
-18.20 / -14.91
-24.72239.71% (+9.82)
2024 (Q4)
-11.87 / -27.09
-27.6311.97% (+0.55)
2024 (Q3)
-18.05 / -16.54
-34.17551.60% (+17.63)
2024 (Q2)
-22.78 / -21.09
-26.17719.44% (+5.09)
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed