Santhera Reports H1 2024 Financials and Corporate Update

Santhera Pharmaceuticals, a Swiss specialty pharmaceutical company, recently announced its financial results for the first half of 2024, along with updates on the progress of AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD).

Revenue from contracts with customers amounted to CHF 14.1 million for the first half of 2024, a significant increase from CHF 3.9 million in the same period of 2023. Despite this, the operating result showed a loss of CHF 17.7 million, though this was an improvement from the CHF 20.3 million loss in the previous year. The net loss also decreased to CHF 15.3 million from CHF 23.3 million year-over-year. Santhera had cash and cash equivalents of CHF 16.5 million as of June 30, 2024, bolstered by additional financing of up to CHF 69 million, which is expected to provide funding into 2026.

AGAMREE has seen successful launches in Germany, Austria, and the United States. In Germany alone, AGAMREE was prescribed to about 300 patients within a few months of its launch. In the U.S., the launch by Catalyst Pharmaceuticals exceeded expectations. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved AGAMREE for DMD in January 2024, making it the first treatment approved for DMD across the U.S., EU, and UK. China’s National Medical Products Administration has also granted priority review status for AGAMREE’s new drug application, with potential approval expected by the first quarter of 2025.

Santhera is expanding its commercialization efforts in Europe, targeting the Nordics, Ireland, and Portugal, while retaining full control in these markets. Additionally, they have signed new distribution agreements to cover the entire European Union and some non-EU markets. The company is also exploring early access programs in various regions, including a paid-for named patient program in Spain and a similar early access initiative in China, which has already seen considerable interest.

Santhera has initiated new clinical studies to further investigate AGAMREE’s safety and efficacy. These include studies focusing on a broader patient age group, ranging from 2 to 18 years, and a Phase 1 study in healthy volunteers to confirm the drug’s mineralocorticoid antagonistic properties. A Phase 2 pilot study in Becker muscular dystrophy (BMD) is also underway to evaluate safety and exploratory clinical efficacy.

The company’s financial performance for the first half of 2024 showed a revenue increase but still operated at a loss. Operating expenses rose to CHF 26.7 million, driven by increased activities to support AGAMREE’s commercialization. Development expenses increased by 40% to CHF 13.8 million, mainly due to additional long-term studies and development activities. Marketing and sales expenses slightly increased to CHF 4.7 million.

Santhera's financial strategies included closing two financing agreements in August 2024, which provided gross funding of approximately CHF 69 million. This includes a CHF 35 million term loan financing from Highbridge Capital Management and a USD 30 million payment from R-Bridge for partial and capped royalty monetization. These funds are expected to support ongoing activities and service debt obligations into 2026.

Overall, Santhera Pharmaceuticals is making significant strides in both the financial and clinical development arenas. The company’s focus on expanding AGAMREE’s market presence in Europe, along with strong early uptake in initial markets, underscores its commitment to addressing unmet needs in the treatment of Duchenne muscular dystrophy.

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