Press Release: Santhera Full Year Results for the -3-

Manufacturing and supply chain

To support global expansion and ensure reliable, cost-effective product availability, Santhera advanced several critical initiatives related to AGAMREE's manufacturing and supply chain in 2024.

The Company began validation of a second commercial-scale manufacturing site in Switzerland in partnership with a contract development and manufacturing organization (CDMO). This site will operate in parallel with the existing facility in Europe and is expected to enhance supply chain resilience, reduce lead times, and lower manufacturing costs through process optimization and localization.

In the United States, Catalyst progressed the qualification of a secondary manufacturing site within the U.S. to support growing demand and mitigate future supply risks. Santhera provided technical support for this initiative, which is expected to bring additional cost and logistical efficiencies to the North American supply chain.

In China, Sperogenix entered early discussions with domestic CDMOs and regulatory authorities to establish a future manufacturing presence in-country, targeting local production readiness by 2028. This initiative is expected to support pricing and reimbursement discussions with Chinese authorities, where domestic sourcing is increasingly favored for essential medicines.

Santhera also implemented upgraded quality assurance systems and added capacity in its global supply and logistics functions. Investments were made in digital tracking tools, demand forecasting models, and compliance systems to prepare for growing multi-market complexity.

The Company's manufacturing strategy remains tightly aligned with its financial discipline, balancing scale-up investments with anticipated revenue growth and ensuring all supply decisions maintain quality, regulatory alignment, and cost-effectiveness.

R&D strategy and pipeline development

The Company will not be investing further in additional indication expansion for AGAMREE in the near term. However, the Company has an option to leverage indication expansion studies undertaken by its partners at a future date. The Company will however continue to use funds to focus on maximizing the opportunity with AGAMREE in DMD and will continue to generate additional evidence of long-term safety on the use of AGAMREE. The Company looks forward to long-term data readout from the GUARDIAN study, expected in Q4 2025.

Santhera remains actively engaged in looking to expand its late-stage pipeline through licensing and distribution agreements, and potential M&A transactions. This would provide operational efficiency within its EU infrastructure leveraging the skill set that already exists within the business. The focus of this activity is on the rare disease field and for assets that have already completed clinical development, therefore not introducing clinical risk into the Company. Santhera is, however, happy to potentially take on regulatory risk due to the company's strength and expertise in the regulatory filing, reimbursement and approval process across Europe.

Financial Review

Financial Performance, Activities & Outlook

In 2024, Santhera achieved a revenue of CHF 39.1 million and a net loss of CHF 42.0 million. The cash reserves of CHF 40.9 million at year-end 2024, together with 2025 product revenue, royalties and milestones, will enable the Company to fund operations towards cash break-even in 2026.

2024 full year revenue driven by strong underlying revenue growth

In 2024, Santhera reported total revenue from contracts with customers of CHF 39.1 million (2023: CHF 103.4 million). Product sales of CHF 15.0 million (2023: CHF 0.8 million) were driven by the successful launch of AGAMREE in Germany and Austria. Royalties and milestones in the year amounted to CHF 16.9 million (2023: CHF 99.9 million), with 2023 revenues being bolstered by out-licensing milestones received from Catalyst in the U.S. and Sperogenix in China. Revenue from supply of product and services to partners was CHF 7.2 million (2023: CHF 2.7 million)

Cost of sales

Cost of goods sold amounted to CHF 15.5 million (2023: CHF 3.2 million), following the commencement of AGAMREE sales. Cost of goods includes CHF 5.0 million in intangible amortization (2023: CHF 2.4 million) and royalties payable of CHF 3.5 million (2023: nil) in addition to costs relating to product supplies and logistics.

Operating expenses and result

Operating expenses of CHF 57.0 million (2023: CHF 32.0 million). The year 2023 was positively impacted by a net gain of CHF 17.7 million on the sale of the idebenone business. Excluding this, 2024 operating expenses were 15% higher year-on-year, primarily due to increased development, marketing and sales expenses, partially offset by lower general and administrative expenses.

Development expenses amounted to CHF 26.5 million (2023: CHF 18.7 million). Adjusting for inventory capitalization, these expenses increased by 24%, stemming from higher third-party clinical and regulatory services. These were largely related to the support of marketing authorization dossiers for AGAMREE in DMD with the authorities in the U.S., China, EU and UK ahead of approval, as well as post marketing long-term extension studies.

Marketing and sales expenses were CHF11.0 million (2023: CHF 9.8 million). This represents an increase of 13% due to activities to support the launches in direct markets of AGAMREE offset by a reduction in expenses following the U.S. out-licensing.

General and administrative expenses amounted to CHF 19.5 million (2023: CHF 21.2 million), a reduction year-on-year of 8%. This reflects the reduction of costs related to licensing activities in 2023, offset by financial activities and the addition of personnel in key functions in view of AGAMREE's launch in European markets.

The operating result amounted to a loss of CHF 33.1 million (2023: income of CHF 68.8 million).

Financial income and expenses

The financial income in 2024 amounted to CHF 11.6 million (2023: CHF 19.4 million). The decrease was predominantly related to changes in fair value of financial instruments and in (un)realized foreign exchange gains.

Financial expenses in 2024 were CHF 20.1 million (2023: CHF 33.4 million), primarily driven by lower interest and make-whole expenses as well as changes in fair value of financial instruments and in (un)realized foreign exchange losses

This resulted in a net financial expense of CHF 8.5 million, a reduction of 39% on the previous year (2023: CHF 14.0 million), reflecting the overall change in funding structure.

Net result

The net result in 2024 was a loss of CHF 42.0 million, compared to a net income of CHF 54.8 million in the year 2023.

Cash balance and cash flows

As of December 31, 2024, the Company had cash and cash equivalents of CHF 40.9 million, compared to CHF 30.4 million as of December 31, 2023.

Net cash outflow from operating activities amounted to CHF 35.5 million (2023: net cash inflow of CHF 47.3 million), the change mainly due to out-licensing receipts in 2023.

Net cash flow used in investing activities was lower year-on-year and amounted to CHF 0.1 million (2023: CHF 18.0 million) with 2023 including the payments for intangibles.

Net cash flow from financing activities in 2024 was CHF 46.1 million (2023: CHF -0.2 million). This was the net result of proceeds from financing transactions (involving warrants, term loan and royalty monetization) totaling CHF 60.1 million which was mainly offset by cash used for financing, above all the repayment of convertible bonds in the amount of CHF 13.5 million.

In summary, the net increase in cash and cash equivalents in 2024 amounted to CHF 10.6 million (2023: net increase of CHF 29.0 million).

Assets and liabilities

Intangible assets decreased by CHF 5.0 million to CHF 68.9 million, reflecting amortization of AGAMREE intangible in use.

Total assets increased to CHF 152.5 million (from CHF 109.6 million in 2023) and included an increase in inventory by CHF 15.7 million to CHF 17.5 million. Trade and other receivables increased by CHF 11.7 million to CHF 13.9 million, reflecting increases in milestones receivable and working capital during the commercialization stage.

Total liabilities increased by CHF 75.1 million to CHF 124.8 million, mainly due to the new term loan and royalty monetization, offset by repayment of convertible bonds as well as working capital increases.

Shareholders' equity

Total consolidated equity as of December 31, 2024, amounted to CHF 27.7 million, compared to a total equity of CHF 60.0 million as of December 31, 2023. This was a result of the net loss for the period as well as the issue of equity during the year.

Royalty and debt financing

In August, Santhera announced the closing of two financing agreements that provided the Company with gross funding totaling approximately up to CHF 69 million. This comprised a new term loan agreement with Highbridge Capital Management LLC (Highbridge) and a royalty monetization agreement with R-Bridge (part of the CBC Group).

Santhera received CHF 35 million through the senior secured loan from Highbridge. The loan has a four-year maturity and an interest rate of 3-month SARON plus 9.75%. The transaction additionally included changes to the existing CHF 7 million Highbridge private convertible bonds, that has a strike price of CHF 10.00, by extending it by 12 months to August 2025. Highbridge also received 236,540 new warrants at an exercise price of CHF 11.0975 and at the same time converted a CHF 4 million bond with a strike price of CHF 5.00.

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