Ascelia Pharma AB (CHIX:ACEs)

Q1 2026 Ascelia Pharma AB Earnings Call Transcript

May 12, 2026 / 08:00 AM GMT

Release Date Price: kr45.05

Transcript

Key Points

Positve

Ascelia Pharma AB (FRA:7ZA) is on track for the FDA approval of its diagnostic drug, Orbiglanz, with a PDUFA date set for July 3, 2026.
The company successfully raised SEK 20 million through a directed share issue, extending its cash runway into 2027.
Orbiglanz addresses a significant unmet medical need for patients with severe renal disease, offering a safer alternative to gadolinium-based imaging agents.
The global market opportunity for Orbiglanz is estimated at $800 million annually, with the U.S. market comprising nearly half of this potential.
Ascelia Pharma AB (FRA:7ZA) has a strong clinical data package for Orbiglanz, including compelling Phase III results, supporting its potential market success.

Negative

The company reported an operating loss of 17 million kroners for Q1 2026, indicating ongoing financial challenges.
There are uncertainties regarding the timing of a partnership agreement for the commercialization of Orbiglanz, which could impact market entry.
The approval process involves significant costs, and the company has not provided specific guidance on how these costs will evolve post-approval.
Ascelia Pharma AB (FRA:7ZA) faces competition from other companies developing manganese-based imaging agents, such as GE Healthcare.
The commercialization of Orbiglanz is contingent on securing a partner, which introduces additional risk and dependency on external parties.

Refinitiv StreetEvents Event Transcript
E D I T E D V E R S I O N

ACELP.ST - Ascelia Pharma AB
Q1 2026 Ascelia Pharma AB Earnings Call
May 12, 2026 / 08:00AM GMT

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Presentation
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Unidentified_1 [1]
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Welcome to Acellia Pharma Q1 2026 report presentation. For the first part of the conference, participants will be in listen-only mode. During the questions and answers, session participants are able to ask questions by dialing pound key 5 on their telephone keypad. Now I will hand the conference over to CEO Magnus Korfitsen, CFO Anton Hansen, and CSO Andreas Norlin. Please go ahead.

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Unidentified_2 [2]
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Welcome, everyone, to the webcast for Acelia Pharma's Q1 report for 2026.

On this call, we will be making forward-looking statements.

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