(RTTNews) – Santhera Pharmaceuticals Holding AG (SPHDF.OB, SANN.SW), a Swiss firm, reported Tuesday a wider loss in its first half mainly due to a $25 million milestone payable, despite improved revenue from contracts.
Backed by direct and partner market growth, the firm now expects fiscal year 2025 revenue to exceed the previous guidance range of 65 million francs to 70 million francs. The firm also expects to be cash break-even by mid-2026.
US partner Catalyst Pharmaceuticals, Inc. continues to project sales of Duchenne muscular dystrophy drug AGAMREE of $100 million to $110 million in 2025.
Further, Santhera reiterated its 2028 revenue guidance of 150 million euros and 2030 guidance of more than 150 million euros in direct market sales alone.
In the Swiss Market, the shares were trading 6.20% lower at 13 Francs.
In the first half, the net loss widened to 38.83 million francs from 15.26 million francs a year ago.
On a per share basis, the loss expanded to 3.04 francs from 1.35 francs in the prior year.
The latest result was hit by the one-time $25 million or 20.3 million francs milestone payable and the financial expenses related to AGAMREE sales.
Loss before taxes widened to 38.76 million francs from 15.09 million francs a year ago.
However, revenue from contracts with customers improved 70% to 24.01 million francs from 14.11 million francs last year.
Net sales improved 76% to 11.58 million francs from 6.56 million francs a year ago, led by the German and Austrian markets, where AGAMREE was launched in 2024.
The company noted that global sales, including partners, of AGAMREE exceeded $100 million on a four consecutive quarter basis.
Further, the firm said it plans to report the new long-term effectiveness and safety results data from the GUARDIAN study of AGAMREE in the early fourth quarter of 2025.
AGAMREE, the firm’s drug catalyst, is chemically known as vamorolone and is used for the treatment of Duchenne muscular dystrophy or DMD, a genetic disease caused by a gene on the X chromosome that mostly affects men.
Dario Eklund, CEO of Santhera, said that the global rollout of AGAMREE has continued at pace with strong demand in the US and increasing expectations in China through Sperogenix Therapeutics.
In addition, the firm has submitted for the presentation of real-world evidence data from both younger and older patient cohorts treated with AGAMREE in Germany, at the World Muscle Society Congress in Vienna, October 7-11.
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