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Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced its preliminary and unaudited financial figures for the first half of 2022. Reporting at Group level is performed for the first time in accordance with IFRS (International Financial Reporting Standards).

The preliminary figures do not yet include purchase price allocation effects from the ATHOS transaction closed in May where Formycon AG acquired 100% of the rights to FYB202, a biosimilar candidate for Stelara®¹, the 50% stake of ATHOS KG in FYB201, a biosimilar for Lucentis®², and the operational development unit Bioeq GmbH. The publication of the final figures respectively the half-year report is scheduled for October 28, 2022.

On the day of reporting, June 30, 2022, the preliminary key financial figures of the Formycon Group were in line with Formycon’s expectations. Turnover within the Group, which alongside Formycon AG also includes the fully consolidated subsidiaries Formycon Project 201 GmbH, FYB202 Project GmbH, Formycon Project 203 GmbH, Bioeq GmbH and the 50% stake in Bioeq AG, which is consolidated at equity, totaled in Euro 17.6 million in the first six months of 2022 (H1/2021 IFRS: Euro 20.2 million). For the full year of 2022, Formycon continues to forecast revenues above last year’s level for the entire Group (2021 IFRS: Euro 37 million).

Preliminary consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) stood at Euro -7.6 million (H1/2021 IFRS: Euro -9.7 million), while the preliminary operating result (EBIT) was around Euro -8.5 million as of June 30, 2022, compared with Euro -10.6 million in the prior-year period. The preliminary consolidated result for the period recorded a significant increase and amounted to Euro 80.0 million (H1/2021 IFRS: Euro -10.6 million).

The preliminary result for the period was dominated by an extraordinary effect, which had no impact on earnings or liquidity and resulted from the sale of the minority stake (24.9%) in FYB 202 GmbH & Co. KG to Aristo Pharma GmbH, following which Formycon AG ceased to be a shareholder of FYB 202 GmbH & Co. KG. In parallel, the acquisition of 100% of the shares in FYB202 Project GmbH, in which the global assets and commercialization rights to FYB202 are located, was realized.

The Group’s financial position continues to be solid: Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled around Euro 18.2 million on the day of reporting, compared to Euro 25.0 million as of December 31, 2021. In addition, as part of the ATHOS transaction, the company was provided with an on-demand line of credit amounting to Euro 50 million, of which Euro 40.0 million have not been utilized and could still be drawn down as of the reporting date.

Currently, Formycon Group is focusing on research and development activities for its fully-owned and out-licensed biosimilar projects, as well as its fully-owned COVID-19 drug (FYB207). The current revenues also result from the development services for the out-licensed or partnered projects. Following the approval of these products, Formycon will also take a share of subsequent commercialization revenues. With the market launch of FYB201 in the United Kingdom (UK) and the briefly upcoming market launch in the United States of America and – following the recently announced approval by the European Commission in late August – in the EU through the respective commercialization partners, Formycon expects first revenues and earnings contributions from the commercialization revenues in the second half of 2022.

As in the previous year, the preliminary operating key figures (EBITDA and EBIT) continue to be mainly attributable to investments in the company’s own pipeline. In the FYB202 project, the extended scope pharmacokinetics Phase I study is currently ongoing, following the completion of which the regulatory submission in Europe and the US is planned for the third quarter of 2023. In project FYB203, a biosimilar candidate for Eylea®³, which has been out-licensed to Klinge Biopharma GmbH (an ATHOS company), recruitment for the ongoing Phase III clinical trial was successfully completed in April 2022. Data on the primary efficacy endpoint are expected by the end of this year.

The FYB206 biosimilar project continues to progress according to plan. Scientific advice meetings with EMA and FDA and scale-up of the manufacturing process to commercial scale are planned for the second half of the year. In the innovative development project FYB207, a promising antiviral drug candidate against SARS-CoV-2 and its variants, preclinical studies are expected to be completed in 2022, the manufacturing process will be adapted to the optimized molecule, and the production of test material for stability studies and clinical trials will be carried out. Entry into clinical trials is planned for 2023. In addition, the development pipeline was expanded by the two new biosimilar projects FYB208 and FYB209.

Formycon AG, as the Group’s parent company and central development and operating unit, will continue to report in accordance with the rules of the German Commercial Code (HGB). Formycon AG achieved a turnover (HGB) of approximately Euro 12.5 million in the first half of 2022 (H1/2021 HGB: Euro 12.4 million). The preliminary result (HGB) for this period amounted to Euro 82.6 million (H1/2021 HGB: Euro -10.0 million) which is also caused by the extraordinary effect described above.

Dr. Stefan Glombitza, CEO of Formycon AG, comments on the preliminary half-year results as follows: “We are extremely satisfied with the performance in the first half of 2022. The successfully realized transaction with ATHOS KG and the first market approval of FYB201 were certainly outstanding events. We also made very pleasing progress in all other development projects and also initiated two new biosimilar projects with FYB208 and FYB209. The international launch of FYB201, which has already started in the UK and will soon continue in US and EU, marks another important milestone for our company. Based on the expected cash flows in combination with a broad and valuable pipeline as well as a strong development organization, we believe we are very well positioned for the continued consistent execution of our growth strategy.”

¹⁾ Stelara® is a registered trademark of Johnson & Johnson
²⁾ Lucentis® is a registered trademark of Genentech Inc.
³⁾ Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.

Munich, Amsterdam, Zug – Formycon AG (“Formycon”), Polpharma Biologics Group BV (“Polpharma Biologics”) and Bioeq AG (“Bioeq”) jointly announce that the European Commission (“EC”) has granted marketing authorization (“MA”) for Ranivisio^® (Ranivisio – Ranibizumab), a biosimilar to Lucentis^® (ranibizumab-injection), for the treatment for several serious retinal diseases in the European Union (“EU”).[i]

EC approval follows a positive opinion issued in June 2022 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein.

Ranivisio^® is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR), as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).[i]

FYB201/Ranivisio^® was developed by Bioeq, a Joint Venture between Formycon and Polpharma Biologics. Mid 2021, Teva Pharmaceutical Industries Ltd. (“Teva”) entered into a strategic partnership for the exclusive commercialization of FYB201 in Europe and selected other countries. Commercial launches across Europe are planned over the coming year, and the treatment is already available in the UK under the tradename Ongavia^®3_, following its approval by the Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.

The EU-approval is based on the totality of evidence including analytical, nonclinical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS-AMD) it was shown that Ranivisio^® is highly similar to the reference product Lucentis^® in terms of comparable efficacy, safety, pharmacokinetics and immunogenicity in patients with age-related neovascular (wet) macular degeneration. ⁱ

AMD is caused by excessive growth of blood vessels in the retina. Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels in the retina. In developed countries AMD is the most common cause of severe visual impairment or blindness and it is estimated that up to 77 million Europeans will be affected by 2050.[ii] The consequences of AMD carry a significant burden for healthcare systems and societies as the increasing incidence of the condition  is expected to absorb considerable amounts of healthcare resources and funds across the EU.

“Due to the demographic development more and more people in Europe are affected by age-related macular degeneration and other severe retinal diseases. This is very often accompanied by significant impairment of quality of life. We are therefore particularly pleased that FYB201/Ranivisio^® – that we have developed together with Polpharma Biologics and Bioeq – can contribute to the treatment options of ophthalmologists and best possible care for these patients,” says Dr. Stefan Glombitza, CEO of Formycon AG.

“With the European launches of Ranivisio^®, Formycon is in transition to a new business phase. We are very happy that in Teva we have a highly reputable and strong commercialization partner on our side for the EU and other markets”, adds Formycon CBO Nicola Mikulcik.

“We are immensely pleased with this recognition by the European regulatory authorities of biosimilar ranibizumab. The production of biosimilars is a process with high levels of scientific rigor and the approval of Ranivisio^® is the culmination of years of dedication by Polpharma Biologics, and our partners, to successfully engineer this medical advancement for those with severe retinal impairments,” says Michael Soldan, CEO of Polpharma Biologics. “We look forward to working with our strategic partners to rapidly get this very important treatment to the people across Europe who need it most.”

¹⁾ Ranivisio^® is a registered trademark of Bioeq AG.
²⁾ Lucentis^® is a registered trademark of Genentech Inc.
³⁾ Ongavia^® is a registered trademark of Teva Pharmaceutical Industries Ltd.

[i]   Ranivisio^® (Ranivisio – Ranibizumab). EU Summary of Product Characteristics, August 2021. Available at: https://www.ema.europa.eu/en. Last accessed August 2022.

[ii]   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. Available at: https://bjo.bmj.com/content/104/8/1077. Last accessed August 2022.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today reported positive preliminary efficacy and safety data from VESPUCCI Phase III clinical trial for FYB202, its proposed biosimilar version of Stelara^®(Ustekinumab).

The multi-center, randomized, double-blinded, comparative clinical study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB202 and the reference medicine Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). This is the most common form of psoriasis, accounting for 80 to 90 percent of all cases.

The primary endpoint of the comparative global Phase III study measures the percent improvement of the Psoriasis Area and Severity Index (PASI) at 12 weeks from baseline. The values obtained for FYB202 and reference product are within the relevant equivalence limits. In addition, to date, no clinically meaningful differences in safety and immunogenicity have been observed.

The extended Phase I pharmacokinetics study has commenced. Recruitment is evolving according to plan and a substantial number of subjects has already been enrolled in the study.

The active ingredient ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23. Since 2009, Stelara^® has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis as well as psoriatic arthritis. Its approved indications were expanded to chronic inflammatory bowel diseases like treatment of Crohn’s disease (2016) and ulcerative colitis (2019). Stelara^® achieved a global sales volume of over USD 9 billion in 2021.

As a result of the transaction with ATHOS KG, which was successfully concluded in the first half of 2022, the global commercialization rights to FYB202 are held in full by Formycon AG (prior to the transaction 24.9% co-ownership share).

Formycon’s CEO Dr. Stefan Glombitza is pleased with the results: “With FYB202 we have a promising biosimilar candidate and are addressing an important and growing market in the inflammatory diseases segment. The positive interim phase III study results mark an important milestone and underline our expertise in the development of high-quality biosimilars.”

* Stelara® is a registered trademark of Johnson & Johnson

Munich, Amsterdam, Zug – Formycon AG (“Formycon”), Polpharma Biologics Group BV (“Polpharma Biologics”) and Bioeq AG (“Bioeq”) jointly announce, that the U.S. Food and Drug Administration (“FDA”) has approved CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection).

FYB201 was developed by Bioeq, a Joint Venture between Formycon and Polpharma Biologics. End of the year 2019, Coherus BioSciences, Inc. (“Coherus”) entered into a license agreement for the exclusive commercialization of FYB201 under the brand name CIMERLI™ in the United States of America (“U.S.”).

CIMERLI™ obtained approval from FDA for the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema following Retinal Vein Occlusion (RVO) and Myopic Choroidal Neovascularization (mCNV). CIMERLI™ is the first and only interchangeable biosimilar with an exclusivity of 12 month after market launch that is indicated for the treatment of all five Lucentis® indications and as such is a new medical option for patients with serious retinal diseases. [i]

FDA-approval and interchangeability designation are based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. Efficacy, safety, pharmacokinetics and immunogenicity of CIMERLI™ were found to be comparable to the reference drug Lucentis® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD). Clinical readouts from the randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS AMD) have been published in the peer-reviewed journal Ophthalmology. [ii]

CIMERLI™ belongs to the anti-VEGF therapy class of biologics that have been revolutionary in helping retinal patients in maintaining or regaining vision. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. The U.S. market for ophthalmic drugs in anti-VEGF therapy is around $7 billion per year and, according to analysts, will continue to grow further. The commercial launch of CIMERLI™, in both 0.3mg and 0.5mg dosages, in the U.S. by Coherus, is planned for early October.

“We are very delighted about the full label approval as it will allow to offer this highly effective treatment option to an increasing number of patients with retinal diseases. At the same time, we would like to thank our partners Bioeq and Polpharma Biologics for the excellent joint development work and are pleased that Coherus acts as commercialization partner for the U.S.,” explained Dr. Stefan Glombitza, CEO of Formycon AG.

“As the impact of serious retinal diseases continues to rise in the U.S., it is critical that treatment options are both efficacious and affordable. Advanced biosimilars to Lucentis® can change patients’ lives, while also minimizing the financial impact of the cost of treatment on healthcare systems,” said Michael Soldan, CEO of Polpharma Biologics Group. “Polpharma Biologics is proud to have collaborated with Formycon and Bioeq on the development of ranibizumab biosimilar and we are excited about our contribution to this valuable treatment option that we expect to positively impact many patients lives.”

1) CIMERLI™ is a trademark of Coherus BioSciences, Inc.
2) Lucentis® is a registered trademark of Genentech Inc.

[i] U.S. Food and Drug Administration (FDA) website. Available from: https://www.fda.gov/
[ii] Holz FG, Oleksy P, Ricci F, et al. Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022; 129 (1): 54-63