Formycon confirms full-year guidance following business development in line with plan – working capital raised

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today reported on the Group’s business development and financial results for the first half of 2025. The Company has continued its operational activities in a targeted manner and achieved significant progress across its biosimilar projects. The first half of the year was characterized by many positive operational milestones, progressive regulatory optimizations, new product launches, the further expansion of international commercialization partnerships, and the successful placement of a corporate bond.

Enno Spillner, CFO of Formycon AG, commented: “Our half-year figures are in line with our expectations and reflect structural effects that were already taken into account when preparing our annual forecast. The positive developments of recent weeks and months strengthen our expectations for a strong and highly dynamic second half of the year – in particular through the further market penetration of FYB202 and potential partnerships for FYB206. Both programs are excellently positioned to make a significant contribution to achieving our targets in both the remainder of the year and, in particular, in the fourth quarter. Our guidance for 2025 therefore remains largely unchanged. With the clearly oversubscribed issuance of our first corporate bond, we have strengthened our financial flexibility and are raising our working capital forecast accordingly. This puts us in a solid operational and strategic position for sustainable corporate growth.”

Group revenue and earnings performance in line with plan – 2025 guidance confirmed and working capital forecast raised

In the first half of 2025, the Formycon Group generated revenues of around €9.0 million (H1/2024: €26.9 million). The anticipated decline compared to the previous year primarily reflects a project-related transition phase and a changed revenue structure: While substantial milestone payments from the FYB202 partnership were recognized in the same period of the previous year, there were no comparable one-off revenues in the reporting period. Similarly, reimbursements for billable development services for FYB201 and FYB203 declined as forecast due to the advanced project status. New revenue from profit sharing for FYB202 was not yet sufficient to compensate for this decline. However, Formycon expects a strong and highly dynamic second half of the year, driven by the conclusion of targeted license partnerships for FYB206 and the further market penetration of FYB202. This applies in particular to Q4/2025.

The Stelara^®2 biosimilar FYB202/Otulfi^®3 was launched commercially by Formycon’s partner Fresenius Kabi at the end of the first quarter. In the U.S., the product is mainly distributed through the pharmacy benefit channel. Market development is still in its early stages and will be built up gradually through further contract signings, which will then generate additional market momentum. In Europe, FYB202 was launched in several countries in March. Since the third quarter, the product has also been marketed semi-exclusively in Germany by Ratiopharm under the trade name Fymskina^®4. Revenue from the direct share in the commercialization of FYB202 amounted to €1.7 million (H1/2024: €0). In line with advancing market penetration, Formycon expects FYB202 to make a significant contribution to revenue.

In the case of the ranibizumab biosimilar FYB201, marketing partner Sandoz decided in the first quarter to temporarily suspend marketing in the U.S. Market-related adjustments to the pricing structure also had a dampening effect on earnings contributions. These structural changes had already been considered in the annual forecast, meaning that business development in the first half of the year was in line with expectations. Revenue from direct involvement in the marketing of FYB201 amounted to €0.8 million (H1/2024: €3.8 million). FYB201 continued to be successfully marketed across 21 markets outside the U.S., including Europe and the MENA region. Additional market momentum is expected in the second half of the year, particularly from the launch of the prefilled syringe in several European countries. This is intended to expand the product offering and specifically strengthen market penetration. The resumption of marketing in the U.S. is planned for the first half of 2026.

Overall, Formycon continues to expect full-year sales of €55.0 to 65.0 million, based on the assumption that sales from the profit share for FYB202 will increase significantly in the second half of the year, particularly in Q4. In addition, licensing activities for FYB206 are expected to play a significant role in revenues in the second half of the year.

The Group’s earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to €-17.9 million in the first half of 2025 (H1/2024: €-16.9 million). Performance was in line with financial planning and primarily reflects the decline in revenues. At the same time, following the successful approval of FYB202 in the fourth quarter of the previous year, the scheduled amortization of the capitalized intangible asset began, resulting in additional non-EBITDA-relevant costs of sales of approximately €12.5 million. As development costs incurred for FYB206 are capitalized, these investments are not recognized in the income statement.

Based on the expected increase in revenues in the second half of the year, Formycon continues to forecast EBITDA for the full year 2025 in the range of €-20.0 million to €-10.0 million.

Adjusted EBITDA amounted to €-19.2 million (H1/2024: €-2.1 million) and includes the earnings contribution from the 50% stake in Bioeq AG. The equity-accounted result of Bioeq AG amounted to €-1.2 million in the reporting period (H1/2024: €14.8 million) and reflects the temporary marketing pause for FYB201 in the U.S. as well as market-driven pricing adjustments. The forecast for adjusted EBITDA of between €-20.0 million and €-10.0 million remains unchanged.

The Formycon Group’s net working capital amounted to approximately €17.0 million as of June 30, 2025 (December 31, 2024: €55.1 million). The decline compared to the prior-year figure is mainly attributable to the capital increase of €83 million realized in February 2024 and project-related payment deferrals. In addition, the cash inflow from the €70.0 million corporate bond successfully placed in July 2025 occurred after the reporting date and is therefore not yet reflected in the balance sheet figures as of June 30. As a result, Formycon is raising its working capital outlook for 2025 from the original range of €25.0 million to €35.0 million to a range of €55.0 million to €65.0 million.

With the completion of the transaction and the associated cash inflow, the financing of ongoing development activities for the existing portfolio and operating business is secured. Formycon is pursuing sustainable and medium-term EBITDA-profitable corporate development and expects to achieve a positive EBITDA result ideally as early as 2026, but no later than fiscal year 2027.

Solid operational start to the year with significant regulatory milestones

Dr. Stefan Glombitza, CEO of Formycon AG, said: “We made strong progress on our growth strategy and reached key milestones in the first half of the year. With FYB202, our second biosimilar has entered international commercialization; the market rollout in the U.S. and Europe remains in its early stages but continues to make steady progress. The development of FYB206 is progressing very well: the successful completion of patient enrollment in the Phase I study confirms the effectiveness of our innovative, streamlined study design and will help us develop our biosimilar projects faster and more cost-efficiently.

Diversification is the key to sustainable success and stability in a dynamic market environment. In recent months, we have intensified our efforts in this direction. Through targeted expansion into high-growth emerging markets, a broad network of regional commercialization specialists, and a strategically balanced, maturing portfolio, we are laying the foundation for tomorrow. Building on our extensive biosimilar experience, combined with AI-driven development and increasingly improved regulatory frameworks, we optimize resources and processes, positioning ourselves lean and efficient to seize the numerous opportunities in the growing biosimilars segment.”

Right at the beginning of the year, the Eylea^®5 biosimilar FYB203 received EU approval under the brand names AHZANTIVE^®6 and Baiama^®7, followed by authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Klinge Biopharma, holding the global marketing rights, established commercialization partnerships with Teva (Europe), Lotus Pharmaceutical (Asia-Pacific), and Valorum Biologics (USA/Canada). Within this framework, Formycon will be responsible for coordinating the supply chain and market supply.

The Stelara^® biosimilar FYB202 received approvals in Canada and the United Kingdom at the beginning of the year. Commercialization partner Fresenius Kabi launched the product in the U.S. at the end of February, followed by market launches in several European countries. In April, the U.S. Food and Drug Administration granted interchangeability status, which facilitates substitution in pharmacies. This was followed in May by the launch in Canada and the assignment of a permanent billing code in the U.S. to ensure reimbursement eligibility. In June, Formycon also signed an agreement with Teva subsidiary Ratiopharm for secondary commercialization in Germany.

Based on positive feedback from the FDA, Formycon decided in February 2025 to discontinue the Phase III trial for its Keytruda^® biosimilar candidate FYB206, as therapeutic comparability can be demonstrated by comprehensive analytical data and an ongoing Phase I PK study. This adjustment significantly accelerates development and reduces the expected investment by over €75 million. Patient recruitment for the study was completed in July, and the first participants have already completed all 17 treatment cycles. Results for the primary endpoint are expected in the first quarter of 2026.

FYB201 (Lucentis^®8 biosimilar) is now approved in 21 countries. In the first half of 2025, FYB201’s global presence was expanded with additional approvals, including Brazil, South America’s largest market. Launch by regional partner Biomm is planned for the fourth quarter. Further approvals were granted in Peru, El Salvador, Honduras, and the Dominican Republic. In addition, an exclusive marketing agreement for Sub-Saharan Africa was signed with Bio Usawa. The launch of a pre-filled syringe in Europe in the second half of the year is expected to further increase market penetration in the region.

In addition to its advanced biosimilar programs, Formycon is also continuing to advance its younger product pipeline. The candidates FYB208, FYB209, and FYB210 are in early stages of development. FYB208 is scheduled to enter clinical development this year.

Successful debt financing underscores attractiveness of the biosimilars business

To finance its growth strategy and expand its investor base, Formycon issued its first corporate bond in June 2025, which was increased from €50.0 million to €70.0 million due to high demand. The four-year, floating-rate bond was placed with institutional and private investors in Germany and abroad. The net proceeds will be used primarily to further develop the biosimilar pipeline and scale up commercial activities.

Key financial performance indicators at a glance in € million

 

	Results H1 2024	Results H1 2025	Guidance 2025 old	Guidance 2025 new	Change
Revenue	26.9	9.0	55.0 to 65.0	55.0 to 65.0	unchanged
EBITDA	-16.9	-17.9	-20.0 to -10.0	-20.0 to -10.0	unchanged
Adjusted EBITDA	-2.1	-19.2	-20.0 to -10.0	-20.0 to -10.0	unchanged
Working Capital	63.0	17.0	25.0 to 35.0	55.0 to 65.0	raised

The complete 2025 half-year report can be found here. 

Conference call and dial-in details

The Executive Board of Formycon AG will discuss the Company’s development and key financial figures in a conference call. The earnings call, which will be broadcast live on the Internet, will take place on August 13, 2025 at 3:00 p.m. CEST and will be held in English.

To participate in the conference call, please register at:

https://webcast.meetyoo.de/reg/F0udEyLuS7H5

After registration, participants will receive a confirmation email with their individual dial-in details.

The presentation and audio webcast can be accessed via the following link:

https://www.webcast-eqs.com/formycon-2025-h1

Following a brief presentation, the Executive Board will be available to answer questions from analysts. The conference call will be recorded and subsequently available on the Formycon website at: https://www.formycon.com/en/investors/publications/.