Overview
Sweden pharmaceutical firm's Q4 net sales amounted to SEK 0, with significant pretax loss
Company received FDA CRL for Dasynoc due to contract manufacturer deficiencies
Company prepares for US market launch of two drugs in 2026
Outlook
Xspray expects FDA re-inspection of contract manufacturer's plant in first half of 2026
Company anticipates potential US launch of two CML drugs in second half of 2026
Xspray plans to finance operations through autumn 2026, may seek additional capital
Result Drivers
REGULATORY CHALLENGES - FDA issued a CRL for Dasynoc due to contract manufacturer deficiencies, impacting approval process
MARKET PREPARATIONS - Co is preparing for potential US launch of two drugs in 2026, aiming to transition to a commercial pharmaceutical company
KEY OPINION LEADER SUPPORT - Positive response from clinics and opinion leaders confirms need for co's technology
Key Details
Metric
Beat/Miss
Actual
Consensus Estimate
Q4 Revenue
SEK 0
Q4 Adjusted EPS
-SEK 0.89
Q4 Adjusted Free Cash Flow
-SEK 41.37 mln
Q4 Pretax Profit
-SEK 37.009 mln
Analyst Coverage
Wall Street's median 12-month price target for XSpray Pharma AB (publ) is SEK60.00, about 148.4% above its February 11 closing price of SEK24.15
The stock recently traded at 2 times the next 12-month earnings vs. a P/E of 3 three months ago
Press Release: ID:nMFN1wRYf5
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(This story was created using Reuters automation and AI based on LSEG and company data. It was checked and edited by a Reuters journalist prior to publication.)