Press Release: Santhera Announces Half Year 2025 -2-

As previously guided, Santhera does not plan near-term investment in additional indication expansions for AGAMREE, though it retains the option to leverage partner-run studies at a future date. Resources will remain focused on maximizing the DMD opportunity. In addition, Santhera remains actively engaged in looking to expand its product portfolio and leveraging its infrastructure through licensing, distribution agreements, and potential M&A transactions, with updates expected in 2026.

Executive and Board changes

During the first half of 2025, there were leadership changes at both the executive and Board levels. In February, Catherine Isted joined as Chief Financial Officer, succeeding Andrew Smith. She brings more than 25 years of life-sciences leadership and was formerly CFO of BenevolentAI, a Euronext-listed AI-driven drug discovery Company. In May 2025, shareholders elected Dr. Melanie Rolli to the Board at the AGM, replacing Dr. Otto Schwarz, who did not stand for re-election. She is a seasoned biopharma executive with over 20 years of international experience and is currently CEO of Helsinn Healthcare.

Financing (further detail given in the financials section)

In September 2025, Santhera secured approximately CHF 20 million in additional growth capital to meet increased product demand from partners and to support the acceleration of global launches. The financing comprised USD 13 million from a royalty monetization with R-Bridge, on terms designed to preserve long-term value while providing near-term growth capital. In addition, Highbridge increased its commitment with a CHF 10 million upsizing of its convertible bond, extending maturity and enhancing financial flexibility.

Guidance and outlook

Based on continued strong growth in both direct and partner markets, FY 2025 revenue is now expected to exceed the previous guidance range of CHF 65-70 million. At the same time the Company has maintained disciplined cost control, with operating expenses (excluding non-cash share-based compensation) for 2025, and on a constant-portfolio basis going forward, expected to remain within the previously guided range of CHF 50-55 million. Santhera reiterates its 2028 revenue guidance of EUR 150 million (including royalties but excluding milestones) and maintains its 2030 guidance of more than EUR 150 million in direct market sales alone (excluding all distributor and licensing market royalties and milestones).

FINANCIAL PERFORMANCE

Financial highlights (including post period events)

-- Total revenue increased 70% to CHF 24.0 million (H1 2024: CHF 14.1

million)

-- Product sales increased 76% to CHF 11.6 million (H1 2024: CHF 6.6

million)

-- Santhera recognized CHF 12.4 million (H1 2024: CHF 7.6 million) from

partners in China and North America, reflecting a 63% increase in

royalties, milestones and product supply

-- Global sales (including partners) of AGAMREE exceed USD 100 million on a

four consecutive quarter basis, triggering a USD 25 million sales

milestone payment reflected in COS

-- Operating expenses of CHF 27.3 million (H1 2024: CHF 26.7million)

-- Operating loss of CHF -35.4 million (H1 2024: loss of CHF -17.7 million).

Excluding the USD 25 million (CHF 20.3 million) milestone, operating loss

was reduced by CHF 2.6 million

-- Cash and cash equivalents at June 30, 2025 of CHF 18.4 million

(December 31, 2024: CHF 40.9 million)

-- In September, the Company secured CHF 20 million in royalty and

convertible bond financing

-- Cash-flow break-even guidance maintained for mid-2026

Net Revenue

In the first half year 2025, Santhera reported revenue from contracts with customers of CHF 24.0 million (H1 2024: CHF 14.1 million) driven by strong sales growth in launched markets in addition to growing royalty and product supply revenue. Net sales amounted to CHF 11.6 million following the continued success of AGAMREE in Germany and Austria with first contributions from the UK following the Q2 launch (H1 2024: CHF 6.6 million). Royalties and net sales to licensing partners increased substantially to CHF 5.4 million and CHF 5.7 million (H1 2024: CHF 0.9 million and CHF 1.2 million), driven by U.S. growth. Milestones in the period reached CHF 0.9 million compared to CHF 5.4 million in H1 2024, reflecting a Chinese milestone received in the prior year.

Cost of sales

Cost of sales increased to CHF 32.1 million (H1 2024: CHF 5.2 million). In addition to increased direct and indirect costs due to growing sales, this figure also reflects the milestone payment of USD 25 million (CHF 20.3 million) to ReveraGen and R-Bridge for the achievement of an AGAMREE sales milestone, which is agreed to be paid in line with cash flow generation. Cost of sales for the six months also included non-cash intangible amortization of CHF 2.5 million (H1 2024: CHF 2.5 million) and royalties payable of CHF 3.7 million (H1 2024: CHF 1.0 million).

Operating expenses and result

Operating expenses of CHF 27.3 million (H1 2024: CHF 26.7 million) were consistent year-over-year. These relate to employee expenses as the Company expands activities to support the commercialization of AGAMREE, offset by decreases in development expenses due to non-recurring longer-term study expenses closing in the prior year.

Development expenses amounted to CHF 11.7 million (H1 2024: CHF 13.8 million). The decrease of -15% was driven by the completion of longer-term studies and CMC (chemistry, manufacturing, and controls) development activities coming to a close in the prior year.

Marketing and sales expenses were CHF 6.8 million (H1 2024: CHF 4.7 million). The increase of 45% was driven by the Company's expansion to support the commercialization of AGAMREE in Europe.

General and administrative expenses amounted to CHF 8.8 million (H1 2024: CHF 8.3 million), with additional activities focused on supporting commercial growth.

The operating result amounted to a CHF -35.4 million loss (H1 2024: CHF -17.7 million loss).

Financial income and expenses

Financial income amounted to CHF 8.1 million (H1 2024: CHF 8.6 million). The decrease was predominantly related to a lower gain in fair value of financial instruments and a decrease in interest receivable.

Financial expenses were CHF 11.4 million (H1 2024: CHF 6.0 million), primarily due to an increase in realized and unrealized foreign exchange losses.

In summary, this resulted in a net financial expense of CHF -3.3 million, compared with a net income of CHF 2.6 million for H1 2024.

Net result

The net result in H1 2025 was a CHF -38.8 million loss, compared to a loss of CHF -15.3 million in H1 2024 mainly driven by the one-time USD 25 million (CHF 20.3 million) milestone payable and the financial expenses.

Cash balance and cash flows

As of June 30, 2025, the Company had cash and cash equivalents of CHF 18.4 million compared to CHF 40.9 million as of December 31, 2024. This represents a decrease of CHF -22.5 million (H1 2024: decrease of CHF -13.9 million).

Net cash flow used in operating activities amounted to CHF -20.6 million (H1 2024: net cash outflow of CHF -15.3 million).

Net cash flow used in financing activities was CHF -1.6 million (H1 2024: CHF -0.4 million).

Assets and liabilities

Intangible assets decreased by CHF -2.5 million to CHF 66.4 million, reflecting amortization in the period.

Total assets decreased by CHF -21.7 million to CHF 130.8 million. This is a result of a CHF -22.5 million reduction in cash and decrease of trade receivables, offset by an increase in inventory to support sales growth following product commercialization.

Total liabilities increased by CHF 8.5 million to CHF 133.3 million driven by the 20.3 million milestone payment owed to ReveraGen and R-Bridge for achievement of sales milestones of AGAMREE, offset by a decrease in the fair value of financial liabilities.

Shareholders' equity

Total consolidated equity as of June 30, 2025, was CHF -2.6 million compared to CHF 27.7 million as of December 31, 2024.

Financing activities

This morning Santhera announced that it has secured approximately CHF 20 million in additional growth capital to meet increased product demand from partners and to support the acceleration of global launches.

R-Bridge royalty monetization agreement (USD 13 million)

Santhera has secured a royalty monetization with existing investor R-Bridge. Under the terms of the agreement, R-Bridge will receive 25% of net royalties on AGAMREE from Catalyst (North America) and Sperogenix (China). Upon closing, R-Bridge will pay Santhera USD 13 million (CHF 10.3 million), net of certain fees, upfront.

This is in addition to an existing agreement under which R-Bridge is entitled to 75% of future royalty income from these licenses. As with the prior arrangement, payments to R-Bridge are capped; once the agreed ceiling or duration is met, North American & China royalties revert to Santhera. Santhera retains buy-back rights over the royalty stream.

Highbridge convertible bond extension (CHF 10 million)

Under the agreement, Highbridge will provide an additional CHF 10 million via a new convertible note. The instrument will also exchange, at parity, the existing CHF 7 million convertible bond that was previously scheduled to mature on 30 September. The new convertible bond will have a three-year maturity, with a conversion price set at a 10% premium to the closing share price on the date of this announcement. In addition, the company will issue Highbridge approximately 110,000 shares as consideration for Highbridge agreeing to increased flexibility in relation to the CHF 35 million 4-year term loan signed in August 2024.

Half Year Report

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September 23, 2025 01:01 ET (05:01 GMT)