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Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announced today that the first patient has been enrolled in the Phase III clinical trial “Lotus” to compare the safety and efficacy of FYB206/pembrolizumab with the immuno-oncology blockbuster drug Keytruda^® (First Patient In). The double-blind, multicenter “Lotus” study is evaluating the best overall response rate (bORR) in patients with non-small cell lung cancer (NSCLC). The comparative treatment comprises up to 17 treatment cycles within 52 weeks. Changes in tumor size will be continuously documented during this period using imaging techniques. Following the comparative treatment, the therapy will be continued for an additional 12 months.

The study design was developed in close coordination with the regulatory authorities U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The trial is being conducted in several countries in Eastern Europe and Southeast Asia and is running in parallel to the Phase I study, which started in mid-June, comparing the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference drug Keytruda^® in patients with malignant melanoma (black skin cancer).

“Immuno-oncology is a relatively young field in cancer therapy and is seen as a great hope for many patients. Pembrolizumab has already demonstrated its efficacy in numerous types of cancer. Additionally, several studies are currently underway to expand the range of indications. This alone highlights the enormous potential of our pembrolizumab biosimilar candidate FYB206 – both in medical and economic terms. In fact, sales of Keytruda^®, currently the world’s best-selling drug, are also continuing to grow.

The start of the Phase III clinical trial represents an important milestone for us in order to provide an effective, safe and cost-effective treatment option for many severely ill cancer patients worldwide in the future,” comments Dr. Andreas Seidl, Chief Scientific Officer (CSO) of Formycon AG.

Non-small cell lung cancer is one of numerous cancer diseases for which the immune checkpoint inhibitor pembrolizumab is indicated. In a wide variety of cancers, cancer cells manage to inhibit the body’s own immune defenses by manipulating so-called immune checkpoints. Pembrolizumab, which targets the immune checkpoint PD-1, ensures that the body’s own T cells can again fight and kill the cancer cells.

Due to the increasing use of the active ingredient in earlier stages of cancer and the continuing high global demand, sales of Keytruda^® increased by 20% year-on-year in the first quarter of 2024.³ As a result, sales of this currently best-selling drug could rise to USD 30 billion worldwide by 2026.⁴

Following the completion of clinical development and subject to approval by the regulatory authorities, Formycon currently anticipates the earliest market entry of FYB206 after the expiry of the market exclusivity of the reference product in the USA from 2029 and in the EU from 2030. First results of the Phase I trial are expected in 2026. Preliminary results of the Phase III trial are to follow in the course of 2027.

¹ Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA

² Non-small-cell lung cancer

³ https://www.merck.com/news/merck-announces-first-quarter-2024-financial-results/

⁴ https://www.reuters.com/business/healthcare-pharmaceuticals/merck-raises-2024-profit-forecast-strong-cancer-hpv-drugs-sales-2024-04-25/

Planegg-Martinsried, Germany – Formycon AG (FWB: FYB) and its commercialization partner Fresenius Kabi jointly announce, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB202, a biosimilar candidate to Stelara^®1 (Ustekinumab) indicated for the treatment of several serious inflammatory diseases.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: „The CHMP recommendation for FYB202, our biosimilar candidate to Stelara^®, is an important prerequisite for approval by the European Commission. With FYB202, more patients with serious chronic inflammatory diseases will have access to high-quality and affordable therapies. This recommendation is an additional confirmation of our great expertise in development and in the regulatory area. Economically, the Stelara® biosimilar is expected to significantly increase Formycon revenues following its global launch and thus contribute to sustainable EBITDA profitability in the medium term.“

Within the approval process, the CHMP’s positive opinion represents an important regulatory step towards the approval of FYB202 in the European Union. The CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization valid in all EU member states, which is expected until early Q4 2024.

Ustekinumab, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, is used to treat various severe inflammatory conditions. FYB202/Ustekinumab has been recommended by the CHMP for approval in the European Union (EU) for the treatment of serious inflammatory diseases in the fields of gastroenterology, dermatology, and rheumatology. The recommendation is based on a thorough evaluation of our comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

In February 2023, Formycon and Fresenius Kabi entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets.

¹Stelara® is a registered trademark of Johnson & Johnson

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) jointly announce that the U.S. Food and Drug Administration (“FDA”) approved FYB203/AHZANTIVE^® (aflibercept-mrbb), a biosimilar to Eylea^®, on June 28, 2024.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “The FDA approval of FYB203/AHZANTIVE^® is another key milestone on our way to becoming the leading pure-play biosimilar developer. It highlights the expertise and experience of our team. With the Eylea^® biosimilar FYB203/AHZANTIVE^® and our already approved Lucentis^®3) biosimilar FYB201, we have achieved an outstanding position in ophthalmic biosimilar therapies. We are thus improving healthcare for patients with retinal diseases by offering effective, safe and, above all, affordable treatment options.”

FYB203/AHZANTIVE^® obtained FDA approval for the treatment of patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO). The active ingredient inhibits the vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea^® reached global sales of around US$ 9 billion⁴⁾, confirming its status as the currently best-selling drug in the field of anti-VEGF therapies.

The FDA approval for FYB203/AHZANTIVE^® is based on a thorough evaluation of our comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB203/AHZANTIVE^® demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Eylea^® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD).

In addition, a marketing authorization application for FYB203 was submitted to the European Medicines Agency (“EMA”) at the end of 2023. A decision by EMA is expected by early 2025 at the latest.

1) AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
2) Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
3) Lucentis^® is a registered trademark of Genentech Inc.
4) Source: https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial/

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) held its Annual General Meeting on 12 June 2024 as an in-person event in Munich. In its presentation, the Management Board provided shareholders with a detailed report on the company’s development and answered all questions in the general debate. Dr Olaf Stiller, long-standing Chairman of the Supervisory Board, chaired the Annual General Meeting for the last time and was bid farewell with great appreciation for his successful collaboration.

The represented shareholders followed the proposals of the Management Board and Supervisory Board and approved all of the Executive Board’s proposed resolution resolutions with large majorities. Both the members of the Management Board and the Supervisory Board were given a formal approval of their actions with majorities of over 96 per cent in each case.

In order to reflect a more international focus and expanded industry and financial expertise on the Supervisory Board in future, new and independent members were elected to the Supervisory Board along with the decision to increase the size of the Supervisory Board from four to five members. Dr Bodo Coldewey, Managing Director of WEGA Invest GmbH, the Wendeln family office, and Nicholas Haggar, currently CEO of healthqube Ltd. and a long-standing executive at major pharmaceutical companies, were elected as new members of the Supervisory Board by large majorities. Dr Olaf Stiller and his deputy Peter Wendeln resigned from the Supervisory Board as planned with effect from the end of the Annual General Meeting. Colin Bond, currently still CFO of Sandoz Group AG, was also elected to the expanded Supervisory Board by a large majority with effect from 1 October 2024. The Supervisory Board was constituted immediately after the Annual General Meeting and elected Wolfgang Essler as the new Chairman and Nicholas Haggar as Deputy Chairman.

Wolfgang Essler, chief representative of the main shareholder ATHOS KG and new Chairman of the Supervisory Board of Formycon AG, commented: “I am very honoured to have been elected Chairman of the Supervisory Board and by the trust placed in me. I would first like to welcome Bodo, Colin and Nick as new members of the Supervisory Board of Formycon AG and look forward to continuing the good and constructive cooperation with my colleagues on the Supervisory Board and the Formycon Management Board. The global market for biosimilars will see strong growth in the coming years and Formycon is excellently positioned to play a decisive role in shaping this development. On behalf of the entire organisation, special thanks go to Dr Olaf Stiller and Peter Wendeln, who have been instrumental in shaping Formycon’s very successful development with great dedication and expertise in their many years as members of the Supervisory Board and in leading roles.”

Votes were cast for 62.16 percent of the share capital. The detailed voting results and further information on the 2024 Annual General Meeting can be found at the Formycon Homepage under Annual General Meeting 2024.

Planegg-Martinsried – Formycon AG (FSE: FYB, “Formycon”) announced today that the clinical development program for FYB206, a biosimilar for Keytruda^®* / pembrolizumab, has started with the inclusion of the first patient.

Dr. Stefan Glombitza, Chief Executive Officer (CEO) of Formycon AG, commented: “With the start of the clinical development program and the first patient in, we have reached a major milestone. We are at the forefront of the development of a pembrolizumab biosimilar. Our FYB206 project not only has immense commercial potential, but above all offers exceptional therapeutic options. We are doing absolutely everything we can to ensure that more cancer patients worldwide can be treated with this drug in the future. After all, only biosimilars combine quality and efficacy with cost efficiency and thus improve healthcare.”

The active ingredient pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. Pembrolizumab binds to the PD-1 receptor and specifically blocks the interaction between PD-1 and its ligand PD-L1. This helps the immune system to activate the body’s own cellular anti-tumor immune response and kill cancer cells.

With its broad range of indications in oncology and sales of USD 25 billion in 2023[i], Keytruda^® is currently the world’s best-selling drug. Due to the increasing number of cancers diagnoses around the world – the International Agency for Research on Cancer (IARC) predicts an increase of 77% by 2050[ii] – further growth in sales are forecasted for pembrolizumab over the coming years.

Formycon has started the clinical development program with a Phase I study to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference product Keytruda^® / pembrolizumab in patients with malignant melanoma (black skin cancer). The first patient was included in the study. For melanoma patients, preventive monotherapy with pembrolizumab after complete surgical removal of the tumor aims to minimize the risk of recurrence. The study design of the “Dahlia” Phase I study was developed in close cooperation with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and anticipates a treatment period of one year for the patients in the trial.

Dr. Andreas Seidl, Chief Scientific Officer (CSO) at Formycon, added: “With our sophisticated study design, we excellently address both the complexity of the mode of action and the requirements of the regulatory authorities. To largely exclude disease-related influencing factors in the investigation of PK equivalence, we have chosen the study indication for the preventive treatment of patients after surgical removal of a melanoma. We are assuming that the influence of the tumor on the variability of the pharmacokinetic parameters is rather low. The fact that our team has successfully put together such a comprehensive clinical program fills me with great pride and once again demonstrates our leading role as a focused biosimilar specialist”.

In the parallel phase III study, the safety and efficacy of FYB206 will be compared with the reference product Keytruda^® in patients with non-small cell lung cancer. Patients will be treated with pembrolizumab and chemotherapy for 24 months as part of a combination therapy. Recruitment is expected to start also very soon.

Following the completion of clinical development and subject to approval by the regulatory authorities, Formycon currently expects the earliest market entry of its biosimilar candidate FYB206 after the expiry of the market exclusivity of the reference product in 2029 for the USA and 2030 for the EU.

[i] Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results – https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2023-financial-results/

[ii] Word Health Organization (WHO): Global cancer burden growing, amidst mounting need for services -https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services

Planegg-Martinsried – Klinge Biopharma GmbH (“Klinge”), licensee and exclusive holder of the worldwide commercialization rights for FYB203, Formycon’s biosimilar candidate to Eylea®¹ (Aflibercept), has entered into an exclusive licensing and supply agreement with MS Pharma for the commercialization of FYB203 in the Middle East and North Africa (“MENA region”).

MS Pharma is a leading regional pharmaceutical company in the MENA region and specializes in the distribution of biotechnological as well as generic drugs. The company will have exclusive rights to license, commercialize and produce FYB203 locally at its new Biosimilars site in Saudi Arabia for the countries covered by the agreement. Commercialization rights for all other territories remain with Klinge. Formycon is entitled to participate in all Klinge income from the agreement with MS Pharma in the mid-single to low-double-digit-percentage range.

MS Pharma is also marketing Formycon’s ophthalmic Lucentis^®2 biosimilar FYB201 in the MENA region and can therefore leverage on established sales channels and an existing commercial infrastructure in the ophthalmic space.

In June 2023, Formycon announced that the biologics license application (“BLA”) for FYB203, has been submitted to the U.S. Food and Drug Administration (“FDA“). The agency assigned a target action date of June 2024. Moreover, FYB203 has been submitted end of 2023 to the European Medicines Agency (“EMA”), expecting regulatory approval beginning of 2025. MS Pharma plans to submit for regulatory approval in MENA countries at the earliest opportunity.

Eylea® (Aflibercept) is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases. It inhibits the vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea^® reached global sales of around US$ 9 billion[i], underlining its status as the currently best-selling drug in the field of anti-VEGF therapies.

“We are delighted that our licensee Klinge Biopharma chose a strong, experienced, and renowned partner for the MENA region. MS Pharma has vast experience in the field of ophthalmology, as we have already learned from our collaboration in the commercialization of our other biosimilar FYB201. Both ophthalmic biosimilars address an important and growing market for the treatment of severe retinal diseases and contribute to alternative and cost-effective therapeutic options in the whole region”, said Nicola Mikulcik, CBO of Formycon AG.

“Our partnership with Klinge Biopharma and the addition of an Aflibercept biosimilar to our product line is a milestone in MS Pharma’s journey to enhance healthcare accessibility in the MENA region,” said Kalle Kand, CEO of MS Pharma. “This agreement not only strengthens our biosimilar portfolio but also reinforces our capability to support local production, ultimately contributing to the regional economy and healthcare system.”

¹Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.

²Lucentis® is a registered trademark of Genentech Inc.

Alira Health has acted as the exclusive financial and strategic and the lawyers of honert Munich as legal advisors to Klinge Biopharma.

[i] Regeneron Reports Fourth Quarter and Full Year 2023 Financial and Operating Results | Regeneron Pharmaceuticals Inc.

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today published figures for the first quarter of financial year 2024.

Enno Spillner, CFO of Formycon AG, comments: “We have made a very good start to the new financial year in line with our plans and are positive about the first three months. In March, Sandoz announced the acquisition of the CIMERLI^® business including the Coherus ophthalmology sales team in the USA, which we very much welcome and are looking forward to working together in the future. We can also report approvals and market launches in Saudi Arabia, Canada and Switzerland and are pleased that our partners MS Pharma and Teva are providing many patients access to this treatment for serious eye diseases.

In February, we completed a cash capital increase with the specialty pharmaceutical company Gedeon Richter with gross proceeds of € 82.8 million. After many years of trustful cooperation in contract manufacturing, this strategic investment by our partner opens up opportunities to jointly exploit long-term strategic opportunities in the areas of development, manufacturing and commercial value creation. We are continuously investing in our pipeline and are well positioned to capitalize on the potential of the rapidly growing biosimilar market and expand our position as one of the few pure-play biosimilar developers.”

Revenues are influenced by milestone payments from the FYB202 project as well as from revenue shares from FYB201 sales

In the first quarter of 2024, the Formycon Group generated revenues of € 17.7 million (Q1/2023: € 32.4 million)[i]. These are below the previous year’s figure but are in line with planning. In the previous year’s quarter of 2023, an additional payment of € 10 million from the commercialization partnership with Fresenius Kabi for the FYB202 project, as well as higher income from development services for the two partnered projects FYB201 and FYB203 led to a strong revenue effect.

A significant share of revenue in the first quarter of 2024 was generated from development services for the partnered projects FYB201 and FYB203 as well as from deferred success payments related to the commercialization partnership with Fresenius Kabi from the FYB202 project. Revenue resulting from direct participation in the marketing of the Lucentis^®[1] biosimilar FYB201 amounted to around € 1.9 million (Q1/2023: € 0.3 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 directly in the revenue but below EBITDA.

The consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to € -5.5 million and is reflecting investments in the pipeline and further corporate development.

For the first quarter of 2024, the at equity result from the existing 50% stake in Bioeq AG amounted to € 4.3 million (Q1/2023: € -6.4 million). This underscores the overall successful operating performance of the FYB201 commercialization. The at equity result is included in the new key financial figure “Adjusted Group EBITDA”, which amounted to € -1.2 million in the first quarter of 2024 (Q1/2023: € -0.4 million).

Strategic investment by Gedeon Richter leads to significant increase in working capital in the first quarter

In February 2024, the Hungarian specialty pharmaceutical company Gedeon Richter Plc (“Gedeon Richter”) became a strategic investor in Formycon with a 9.1% stake as part of a cash capital increase excluding subscription rights. The rationale behind the transaction is the shared common interest in the development and production of future biosimilars and in further potential operational cooperation. Formycon issued 1,603,877 new bearer shares with a pro rata amount of the share capital of € 1.00 each against cash contribution at a placement price of € 51.65 per new share by partially utilizing the authorized capital.

Through the transaction, Formycon generated gross proceeds of € 82.8 million, which will be used primarily for the further development of the FYB206, FYB208 and FYB209 projects. In addition, the launch of FYB210, a new biosimilar candidate, is planned for the second half of the year.

Formycon’s net working capital increased significantly to € 84.2 million as of March 31, 2024 (December 31, 2023: € 38.9 million). It includes cash and cash equivalents of € 56.9 million (December 31, 2023: € 27.0 million). The shareholder loan has now been repaid in full. The flexible shareholder credit line of up to € 48 million remains in place.

Formycon confirms the financial guidance issued in April for the 2024 financial year. Assuming the expected approvals and market launches as well as potential out-licensing of biosimilar candidates, Formycon is aiming for a positive EBITDA in the medium term.

Operative milestones for FYB201 and FYB202 reached in the first quarter

In early March, the partner for the MENA region MS Pharma received marketing authorization for FYB201 from the Saudi Food & Drug Authority and won the state NUPCO tender in Saudi Arabia. FYB201 is expected to be marketed under the trade name Ravegza^®[2] in Saudi Arabia from the second quarter of 2024. In addition, following Jordan and Saudi Arabia, market launches are also planned in Algeria and other Gulf Cooperation Council (GCC) countries in the course of 2024.

Subsequent to the end of the reporting period, the commercialization partner Teva announced the market launches of FYB201 in Canada under the trade name Ranopto^TM[3] and in Switzerland under the trade name Ranivisio^®[4].

For FYB202, the biosimilar candidate for Stelara^®[5] (ustekinumab), Formycon and its commercialization partner Fresenius Kabi have successfully concluded a settlement agreement for Europe and Canada with Johnson & Johnson. As early as August last year, it was ensured that FYB202 can be launched on the US market no later than April 15, 2025, following approval. 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.

Several approval decisions and the start of the next clinical program mark important milestones for the 2024 financial year

Formycon is expecting important approval decisions for the biosimilar candidates FYB202 (ustekinumab) and FYB203 (aflibercept) in the USA and Europe in the course of 2024, which are expected to contribute to revenue growth from 2025 onwards, following the successful start of commercialization. The start of the clinical development program for FYB206, the biosimilar candidate to Keytruda^®[6] (pembrolizumab), is planned with the treatment of the first patient (first patient-in) in the course of 2024. Formycon continues to invest in the expansion of its biosimilar platform and further extended its product pipeline with the two earlier biosimilar candidates FYB208 and FYB209. In addition, the plan is to continue the expansion in 2024 with the initiation of the FYB210 project.

Conference call and dial-in data

The Management Board of Formycon AG will discuss the development of the company and the key financial figures for the first quarter of the financial year 2024 in a conference call. The conference call, which will be broadcasted live on the Internet on May 8, 2024 at 3:00 p.m. (CEST) in English.

To participate, please register at:

https://webcast.meetyoo.de/reg/f7ngieeBvHNo

You will then receive a confirmation e-mail with the telephone number, access code and PIN for the call.

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

https://www.webcast-eqs.com/formycon-2024-q1

Following a short presentation, the Management Board will be available to answer analysts’ questions. The conference call will be recorded and will be available afterwards on the Formycon website at: https://www.formycon.com/en/investor-relations/facts-figures/

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

[2] Ravegza^® is a registered Trademark of MS Pharma

[3] Ranopto^TM is a Trademark of Teva Canada Ltd.

[4] Ranivisio^® is a registered Trademark of Bioeq AG

[5] Stelara^® is a registered Trademark von Johnson & Johnson

[6] Keytruda® is a registered Trademark of Merck Sharp & Dohme LLC

[i] For the Q1 2023 reporting the company preliminarily assumed that revenues from the license agreement for FYB202, including upfront and milestone payments would be realized at “point in time” when they were due under IFRS 15. With further evaluation of revenue recognition of the respective contract during the second quarter of 2023 it became evident that revenues recognition has to be handled as following: Upfront payments, relating to the at that point unfinished license, fulfilled the criteria of IFRS 15 and thus to be realized at the respective point in time of the payment, while revenues from milestone payments relating to development milestones need to be realized over time based on the cost-to-cost method in relation to the respective development expenditure. This also resulted in the associated expenditure no longer falling under IAS 38 and therefore no longer being capitalized as internally generated intangible asset but recognized as cost of sales in the statement of comprehensive income.

After retrospective correction as of Feb. 1, 2023 the published key performance indicators for 1Q 2023 change as follows, increasing Revenues as well as Cost of Goods Sold and therefore being without significant impact on EBITDA or Net Income: