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Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today announced preliminary, unaudited consolidated figures for the 2023 financial year and overall looks back on the past year very positively. The year was characterized by further market launches of the biosimilar FYB201 and important progress in the development of the biosimilar candidates FYB202 and FYB203, for which regulatory applications have been submitted in both the USA and Europe.

Milestone payments from the FYB202 project, revenue share from FYB201 sales, and income from development services are reflected in rising revenues

In 2023, revenues increased to around € 77.7 million (2022: € 42.5 million), which corresponds to growth of around 83% compared to the previous year. Therefore, the revenues were within the forecasted corridor of between € 75 million and € 85 million. In addition to income from development services for the out licensed and partnered projects FYB203 and FYB201, a significant proportion of revenue resulted from several milestone payments due to the commercialization partnership concluded with Fresenius Kabi for the FYB202 project in the first quarter of 2023. Of these, a milestone payment anticipated for 2024 was already partially realized in advance and reported in the financial year 2023 as a correspondingly deferred, expected success payment.

The marketing of the ranibizumab biosimilar FYB201, which is now available in a total of 17 countries worldwide, also contributed to an increase in revenue and net earnings contributions. Revenue resulting from direct participation in the marketing of the Lucentis®[1] biosimilar FYB201 amounted to around € 4.1 million. A further significant part of the FYB201 revenue was realized as part of the 50% at equity investment in Bioeq AG and is therefore not shown in the revenue but below EBITDA. For the financial year 2023, the at-equity result totaled to € 11.8 million (2022: € -12.9 million), which is included in the newly established key performance indicator “Adjusted Group EBITDA” and thus reflects the overall operating performance including the FYB201 marketing success.

EBITDA positive for the year as a whole

Contrary to the original forecast, which was in the range of € -5 million to € -15 million, consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) were positive for the year as a whole and amounted to around € 1.5 million (2022: € -15.9 million). This result is mainly due to the increase in revenue and significantly lower than originally anticipated investments in the COVID-19 project FYB207.

New KPI “Adjusted Group EBITDA” shows operating performance including the success in marketing FYB201, and will replace the net result as a performance indicator in future financial statements

In future reporting, Formycon will replace the previous financial performance indicator “consolidated net result” with the new indicator “adjusted Group EBITDA”. From the management’s perspective, the net result is significantly influenced by the fair value assessment of the contingent purchase price payment from the transaction with ATHOS in 2022, which in turn depends on various external factors (such as the applicable interest rate (WACC)). Due to the high volatility of these factors, net result, at the company’s current stage, does not adequately reflect the operational business model’s performance after taxes, considering all expenses and revenues for the relevant period.

As a result of the outlined effects, the Group net result encompasses non-cash adjustments in financial income, culminating in a total of € 75.8 million (2022: € 36.0 million, including a one-off effect) and is therefore above the forecasted range of € 50 million to € 60 million.

The adjusted Group EBITDA aims to present the total revenue from the FYB201 project, which is reported below EBITDA as at equity results due to the existing 50% stake in Bioeq AG, as regular operating income. This adjustment facilitates a clearer emphasis on the direct financial contributions of FYB201 to the business success of the Formycon Group and provides a more transparent insight into the company’s actual operational performance.

The adjusted Group EBITDA for the 2023 financial year totaled to € 13.3 million (2022: € -28.8 million), which is particularly attributable to the significantly increased earnings contributions from Bioeq AG, amounting to € 11.8 million (2022: € -12.9 million).

Stable working capital

As of December 31, 2023, the Formycon Group’s working capital amounted to approximately € 38.9 million (December 31, 2022: approximately € 14.0 million) and included cash and cash equivalents of € 27.0 million (December 31, 2022: € 9.8 million). It was thus above the forecast corridor of between € 15 million and € 25 million. In addition to the successful business performance in the year under review, the increase in cash and cash equivalents can be attributed to the capital increase carried out in February 2023 with gross proceeds of € 70.1 million.

“We look back on a very successful financial year with significant progress in development projects and deliver strong preliminary financial figures for the Formycon Group. We have made significant progress in all areas – from clinical development, regulatory milestones and key commercial partnerships to substantial revenue increases and stable financing,” commented Formycon CEO Dr. Stefan Glombitza.

“The positive development of our key financial figures and the progress made in our projects confirm that we are clearly on track. We continue to pursue our strategy of investing sustainably in our biosimilar pipeline in order to ensure the rapid and parallel progress of our projects. We want to consolidate our position as one of the few pure play biosimilar developers and further expand this position in a dynamic environment,” said Enno Spillner, CFO of Formycon AG.

Outlook for the 2024 financial year

For 2024, the Formycon Group expects sales revenue of between € 55 million and € 65 million. This will mainly result from sales contributions from the marketing proceeds of FYB201, which will be launched in additional countries and regions in 2024. In addition, there is expected revenue from development services for the out-licensed and partnered projects FYB203 and FYB201, which are lower than in previous years due to the advanced stage of the projects. Some of the revenue from the milestone payments expected for FYB202 in 2024 were already recognized in 2023 and reported as an expected deferred success payment. Therefore, the milestone payments will not be reflected in full as revenue in 2024, which is why the revenue forecast for 2024 is below the previous year’s level.

As Formycon continues to operate in an intensive investment and transition phase, the management expects EBITDA for the 2024 financial year to be in the range of € -15 million to € – 25 million. This is mainly due to the planned development costs for the biosimilar projects FYB208 and FYB209, which are progressing into more cost-intensive project phases. There are also plans to expand the portfolio with a new project, FYB210. FYB206, a biosimilar candidate for Keytruda^®[2], currently the world’s best-selling oncology product (annual sales 2023: USD 25 billion), is to enter clinical development in the course of 2024, which will lead to significant investments in the years 2024 to 2026. Due to the capitalization of the costs incurred, these are not reflected in the income statement and therefore not in EBITDA.

Adjusted Group EBITDA is expected to be in a range between € -5 million and € -15 million.

Working capital is expected to range between € 10 million and € 20 million in 2024, which is due to the investments in the FYB206 project and the scheduled partial repayment of shareholder loans.

Formycon will publish the final and audited figures for the 2023 financial year as well as the annual report on April 25, 2024. During a conference call, the Management Board will discuss the performance of the company and key financial figures. The conference call, which will be broadcast live online, will be held in English on April 25, 2024, at 3:00 p.m. (CEST). Dial-in details will be announced shortly.

[1]Lucentis® is a registered trademark of Genentech Inc.,

[2]Keytruda® is a registered trademark of Merck Sharp & Dohme LLC

Munich, Germany – Formycon AG (FSE: FYB) and Bioeq AG announce the commercial launch of FYB201, a biosimilar to Lucentis^®1 (Ranibizumab), in Canada and Switzerland. The launch follows the marketing authorization granted by Health Canada under the trademark Ranopto^TM2and Swissmedic under the trademark Ranivisio^®3.

“Due to demographic developments, more and more people are affected by age-related macular degeneration and other retinal diseases, especially in industrialized nations. These diseases are often accompanied by a severe impairment in the quality of life. FYB201 is a new high-quality, effective and yet affordable treatment option for patients affected by such debilitating conditions. Teva is a strong commercialization partner with a proven track record in successfully launching FYB201 across major European markets and – like us – is convinced of the great potential of our biosimilar,” commented Nicola Mikulcik, CBO of Formycon AG.

FYB201 was developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV. As a biosimilar to Lucentis^®, FYB201 has already proven to be an important, cost-effective treatment option for patients with severe retinal diseases in the USA and large parts of Europe. In mid-2021, Bioeq and Teva entered into a strategic partnership for the exclusive commercialization of FYB201 in Canada, Europe and other territories. In Canada and Switzerland, FYB201 has been approved for the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases.

The wet form of AMD is caused by excessive growth of blood vessels in the retina. The active ingredient ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels. In many developed countries, AMD is the leading cause of severe visual impairment or blindness. The risk of developing AMD increases with age. It is estimated that around 67 million people in Europe are currently affected[i], while around 2.5 million people in Canada suffer from AMD[ii]. The numbers are expected to continue to rise in the coming years.

¹ Lucentis® is a registered trademark of Genentech Inc.
² Ranopto^TM is a trademark of Teva Canada Limited
³ Ranivisio® is a registered trademark of Bioeq AG

[i] Li JQ, Welchowski T, Schmid M, et al. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084.: https://bjo.bmj.com/content/104/8/1077.

[ii] Larissa Moniz, Chad Andrews, Jennifer Pereira: „Canadian patient experience with age-related macular degeneration“ in ARVO Annual Meeting Abstract, June 2022
https://iovs.arvojournals.org/article.aspx?articleid=2781783

Munich, Germany – Formycon AG (FSE: FYB) and its commercialization partner Fresenius Kabi today announced the signing of a settlement agreement with Johnson & Johnson concerning the commercialization of FYB202, a biosimilar to Stelara^®1 (ustekinumab), in Europe and Canada. It was agreed to keep the terms of the agreement confidential.

Nicola Mikulcik, Chief Business Officer of Formycon AG, commented: “Achieving this settlement is testament to our strategic approach of ensuring we make early preparations to expand patient access to critical treatments. Our aim is to make a significant difference in patients’ lives by providing them with reliable, high-quality, and affordable treatment options. Following the settlement for the US, this is another important step that underlines the joint effort of Formycon and Fresenius Kabi, and it solidifies our position to make FYB202 accessible in key global markets.”

FYB202 is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 and is used for the treatment of various severe immune-mediated disorders. Stelara^® is approved for the treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis. The marketing authorization application for FYB202 was accepted for review by the European Medicines Agency (EMA) in September 2023 and by the U.S. Food and Drug Administration (FDA) in November 2023. In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement for the ustekinumab biosimilar candidate FYB202, under which FYB202 will be marketed by Fresenius Kabi in key global markets following successful approval.

¹⁾Stelara^® is a registered trademark of Johnson & Johnson.

Munich, Germany/Amman, Jordan – Formycon AG (FSE: FYB) and MS Pharma announced today that FYB201, a biosimilar to Lucentis^® (Ranibizumab), has received marketing authorization from the Saudi Food & Drug Authority. Following the successful market launch in Jordan last year and with winning the NUPCO tender in Saudi Arabia, FYB201 is expected to be available in another country in the MENA region from the second quarter of 2024. In addition, further market launches are planned in Algeria and other Gulf Cooperation Council (GCC) markets over the course of 2024. In Saudi Arabia, MS Pharma will market the biosimilar under the trade name Ravegza^®.

FYB201/Ravegza^® was developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV. As a biosimilar to Lucentis^®, FYB201 has already proven to be an important, cost-effective treatment option for patients with severe retinal diseases in the USA and large parts of Europe.

At the end of 2021, the company entered into an exclusive partnership with MS Pharma for the commercialization of FYB201 in the Middle East and North Africa (MENA) region. This strategic collaboration aims to improve access to ophthalmic treatments in the MENA region.

Ravegza^® is approved in Saudi Arabia for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases including retinopathies secondary to diabetes. In Saudi Arabia, millions of individuals grapple with Diabetes Mellitus (DM) and its complications. The prevalence of diabetic retinopathies (DR) is approximately 19.7%[i], resulting from damage to blood vessels in the retina due to prolonged high blood sugar levels. Additionally, Diabetic Macular Oedema (DME) affects 5.7% of the population, leading to fluid accumulation in the macula, vision impairment and even blindness. By inhibiting vascular endothelial growth factor (VEGF), Ravegza® is indicated to treat nAMD and DME effective and cost-efficient.

“The successful approval of FYB201 in Saudi Arabia underlines the quality of our biosimilar and its importance as an affordable treatment option for DME, one of the most common causes of severe visual impairment and blindness in the middle east,” said Nicola Mikulcik, CBO of Formycon. “Our partner MS Pharma winning the important NUPCO tender in Saudi Arabia is an outstanding achievement, as it enables us to serve a significant part of the public healthcare sector in Saudi Arabia.”

Kalle Känd, CEO of MS Pharma, stated, “The approval of Ravegza® in Saudi Arabia represents a significant milestone in the company’s ongoing mission to improve patient health and expand our services providing high quality accessible medicines. Biosimilar and specialty medicines are integral to MS Pharma product portfolio and play a crucial role in advancing our growth objectives in the MENA region. We are very proud that we will be making a substantial contribution to public healthcare through the government tender awarded in Saudi Arabia. This approval supports the company’s commitment to the Saudi market and its broader strategic initiatives within the kingdom.”

[i] AlQahtani AS, Hazzazi MA, Waheeb SA, Semidey VA, Semidey VA, Elgendy HK, Alkhars WI, Abouammoh MA, Al-Dhibi H. Saudi Arabia Guidelines for diabetic macular edema: A consensus of the Saudi Retina Group. Saudi Med J. 2021 Feb;42(2):131-145. doi: 10.15537/smj.2021.2.25623. PMID: 33563731; PMCID: PMC7989293. https://pubmed.ncbi.nlm.nih.gov/33563731/

Munich, Germany/Budapest, Hungary – Formycon AG (FWB: FYB) (“Formycon”) today announced that Hungary based specialty pharmaceutical company Gedeon Richter Plc. (“Gedeon Richter“) becomes strategic investor via cash capital increase from authorized capital in the amount of 9.08% of Formycon’s share capital.

Both companies are convinced of the huge potential of biosimilars and share the strategic proximity as well as the respective expertise in their fields of activity.

The clear focus of Formycon as a leading dedicated and independent developer of biosimilars and the operating radius of Gedeon Richter as a major multinational company with core competences in research and manufacturing, combine complementary strengths under the same vision as both companies are highly driven to improve patient’s access to important biologic therapies.

Based on the resolutions of Formycon’s Management Board and Supervisory Board, Gedeon Richter subscribed a cash capital increase of 9.08% in a private placement. The Company’s registered share capital will be increased by partially utilizing the authorized capital from currently EUR 16,053,025.00 by EUR 1,603,877.00 to EUR 17,656,902.00 by issuing 1,603,877 new no par-value bearer shares, each with a nominal value of EUR 1.00 of the share capital, against cash contribution. The placement price per new share is EUR 51.65 and represents the mean average value between today’s XETRA closing price and the volume-weighted average price of the shares over the last thirty trading days. Shareholders’ subscription rights for the new shares were excluded in accordance with § 4 (3) of the Articles of Association. Gedeon Richter will be subject to a customary lock-up obligation of 180 days.

The total inflow of funds amounts to EUR 82.84 million and will be used primarily for the further development of Formycon‘s existing biosimilar pipeline, especially FYB206, FYB208 and FYB209. In addition, the start of FYB210, a new biosimilar candidate, is planned for second half of this year.

“Robust supply and cost-competitive manufacturing are becoming increasingly important as a key component of the biosimilar value chain. Over the past few years, we have established a very trustful and successful operational cooperation with Gedeon Richter by utilizing their state-of-the-art manufacturing capabilities and I am very happy that we can enrich this partnership now even further. This transaction has the potential to generate strong momentum as it enables both parties to jointly leverage strategic long-term opportunities,” comments Dr. Stefan Glombitza, CEO of Formycon AG.

“From a financing perspective the cash funding secures the undamped simultaneous development of our competitive biosimilar candidates while adding a renowned collaboration partner as anchor investor who is clearly welcomed by our supervisory board and management board,” adds Enno Spillner, CFO of Formycon AG.

“The capital increase announced today serves to reinforce our strategic partnership with Formycon, with the aim of broadening patient access to biological therapies globally. Joining forces in this way will provide scale benefits and new business opportunities for both parties, while ensuring mission critical knowledge and experience transfer in a fast-evolving industry,” adds Gábor Orbán, CEO of Gedeon Richter Plc.

Munich, Germany – Formycon AG (FWB: FYB) today announced that its commercialization partner, Coherus BioSciences, Inc. has released new sales figures for CIMERLI^®1 (Ranibizumab-eqrn) in the US.  Accordingly, the number of CIMERLI^® doses sold since its commercial launch in the US in October 2022 has increased to around 190,000 by the end of 2023. In October 2023, the number of doses sold was reported at 100,000. Thus, the amount almost doubled in the fourth quarter of 2023. According to Coherus, cumulative sales of CIMERLI^® in the US totaled USD 125 million, exceeding original expectations by around 25%.² Formycon benefits from net sales in the low double-digit million range, which are reflected partly in sales and partly in the at-equity result of the 50% participation in Bioeq AG.

CIMERLI^® is the first FDA-approved Lucentis^®3-biosimilar for both strengths. In December 2023, CIMERLI^® achieved a market share of 38% by volume in the US Ranibizumab market⁴ and thereby continues to be the most successful biosimilar in this segment.

„We are extremely pleased with the successful uptake of our Lucentis^® biosimilar in the US, which has continued to gain momentum from quarter to quarter. The figures are similarly positive in the UK, where FYB201 (trade name: Ongavia^®5) achieved a market share of 69% in November 2023.⁶ This is confirmation of the outstanding quality of our biosimilar and the strong performance of our commercialization partners. With recent approvals in Canada, among others, and subsequent expected approvals and launches in Latin America, the Middle East and North Africa, we see how this highly important treatment option in the field of ophthalmology reaches more and more markets and can contribute to the best possible care for patients,“ commented Dr. Stefan Glombitza, CEO of Formycon AG.

¹⁾CIMERLI^® is a registered Trademark of Coherus BioSciences, Inc.
²⁾Preliminary, unreviewed and unaudited financial information of Coherus BioSciences, Inc.
³⁾ Lucentis^® is a registered Trademark of Genentech Inc
⁴⁾ IQVIA WSP & NSP
⁵⁾Ongavia^® is a registered trademark of Teva Pharmaceutical Industries Ltd.
⁶⁾IQVIA Monthly Data

Munich, Germany – Formycon AG (FSE: FYB), a leading, independent developer of high-quality biosimilars, today announced that Formycon CEO Dr. Stefan Glombitza will present at the upcoming 42^nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 09, 2024, at 8:15 a.m. PT (5:15 p.m. CET).

Investors, analysts, members of the media and the general public are invited to listen to the live audio webcast of the presentation and Q&A session via this weblink. Subsequently, the webcast will also be available as a replay for 30 days on the Formycon homepage in the Investor Webcast Section.

Members of the Formycon Management Team will be hosting one-on-one investor meetings in San Francisco during the JP Morgan week and participate in Meru Advisor’s corporate access event. We welcome the opportunity to connect in person. To request a meeting, please contact the Meru Advisors via this link.