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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:

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) has published the invitation to its Annual General Meeting on Wednesday, June 12, 2024. The Annual General Meeting will be held as an in-person event for shareholders and their proxies from 11 a.m. (CEST) at the Haus der Bayerischen Wirtschaft in Munich.

The agenda for this year’s Annual General Meeting includes proposed resolutions for the election of two new members to the Supervisory Board, an increase in the size of the Supervisory Board from four to a total of five members and the election of a new member to the expanded Supervisory Board. The aim is to achieve a more international focus and expand the industrial and financial expertise of the Supervisory Board with new independent members.

In agreement with Formycon, the Chairman of the Supervisory Board, Dr. Olaf Stiller, and his Deputy, Peter Wendeln, have decided to resign from the Supervisory Board after more than 10 years of service with effect from the end of the Annual General Meeting on June 12, 2024.

The Executive Board of Formycon AG therefore proposes to the Annual General Meeting that a total of three new members be elected to the Supervisory Board. Dr. Bodo Coldewey, Managing Director of WEGA Invest GmbH, the family office of the Wendeln family, and Nicholas Haggar, currently CEO of healthqube Ltd and long-standing executive at major pharmaceutical companies, are standing for election to replace the outgoing members. Colin Bond, currently CFO of Sandoz Group AG, will be proposed as a new member of the expanded Supervisory Board effective 1 October 2024.

The previously elected Supervisory Board members Wolfgang Essler, General Authorized Representative of ATHOS KG, and Klaus Roehrig, Founding Partner of the Active Ownership Group AOC, will continue their duties. Wolfgang Essler has agreed to take over as Chairman of the Supervisory Board following the election of the new Supervisory Board by the Annual General Meeting.

Dr. Olaf Stiller, Acting Chairman of the Supervisory Board, commented on his decision to support and initiate the more international approach and the expansion of the Supervisory Board: “Formycon has made impressive progress in recent years and is on track for expansion with a growing and sustainable biosimilar pipeline. Now, it is the right time to pass the baton to new hands. I co-founded the company, have actively supported it for a long time and will remain closely associated with it as I am very proud of this great company with its experienced and strong team”.

Peter Wendeln, Deputy Chairman of the Supervisory Board, said: “As an investor from the very beginning and today Formycon’ s second largest shareholder, I am very interested in ensuring that the path we have taken, and the greater internationalization of the business are successful. In addition to strong partners in manufacturing and commercialization, it is important to have an internationally focused management and Supervisory Board team with a strong sector network and financial expertise, and to adapt and strengthen this team in line with the company’s development. Like Dr. Olaf Stiller, I will remain closely associated with Formycon and proudly follow its further development.”

Stefan Glombitza, CEO of Formycon AG, commented: “The biosimilars market will grow rapidly in the coming years. The development and commercialization of biosimilars will enable us to achieve our mission of providing high-quality medicines. The entire Management Board of Formycon AG and its employees are extremely committed to this task and are working with great passion to lead Formycon into a promising and profitable future. We would like to thank Dr. Olaf Stiller and Peter Wendeln from the bottom of our hearts for their tireless commitment to Formycon as Supervisory Board members, for their strategic vision as investors and for the great support that my colleagues and I have received over the years. As Management, we welcome the new suggestions for the Supervisory Board and its expansion to five members and hope for the approval of our Annual General Meeting.”

On June 12, 2024, the following candidates will stand for election by the shareholders:

Colin Bond

Colin Bond is currently CFO of Sandoz Group AG, Basel, Switzerland and will retire from Sandoz on June 30, 2024. Before joining Sandoz, he was CFO of Vifor Pharma from 2016 to 2022 and prior to that CFO of Evotec AG from 2010 to 2016. During his early career, he worked as a pharmacist, auditor, and management consultant for Procter & Gamble, Arthur Andersen, and PricewaterhouseCoopers LLP, respectively. His academic background includes a BSc. in Pharmacy and an MBA degree from London Business School. He is a fellow of the Institute of Chartered Accountants in England and Wales and a member of the Royal Pharmaceutical Society. Colin Bond holds dual British and Swiss citizenship.

Dr. Bodo Coldewey

Dr. Bodo Coldewey is Managing Director of WEGA Invest GmbH, the family office of the Wendeln family, and has extensive experience in corporate management and investments. He plays a central role in the strategic direction and management of significant assets of the family office. Prior to his time at WEGA Invest, Dr. Coldewey held senior positions in the banking, investment and consulting sectors. He therefore brings not only the necessary financial expertise, but also a valuable entrepreneurial perspective to the Supervisory Board.

“The Family Office Wendeln has accompanied Formycon for many years and it would be a great pleasure for me to take over the mandate from Peter Wendeln, who would like to retire from operational Supervisory Board work, and to be able to support this rising company with my expertise as it continues to grow.”

Nicholas Haggar

Nicholas Haggar is a British citizen and CEO of healthqube ltd, Berkhamsted, UK, a venture capital investment firm focused on pharmaceutical and biotechnology companies. Investments focus on specialty, biologics and innovative medicines. He has gained extensive experience in the biopharmaceutical industry and held executive positions in renowned pharmaceutical companies such as GSK, Sandoz and Zentiva over the last 30 years. His broad skills in corporate development and his commitment to the development of biosimilars make him a valuable leader in the industry.

“Formycon is already one of the most successful pure-play biosimilar developers with an excellent international reputation. I would like to bring my many years of experience in this emerging market segment to the company and contribute to the further development of Formycon.”

Further information:

The invitation for the Annual General Meeting and further voluntary information on the candidates proposed for election, including information on memberships in statutory supervisory boards and comparable domestic and foreign supervisory bodies, are available on the company’s website at https://www.formycon.com/en/investor-relations/annual-general-meeting-2024/.

Planegg-Martinsried – Formycon AG (FWB: FYB, ‘Formycon’) today announced details of the conference call to release the results of the first quarter 2024 on May 08, 2024. The management board will discuss the company’s developments and key financial figures and will provide an outlook for the year 2024. The conference call, which will be broadcasted live on the internet, will take place on May 08, 2024, at 3:00 PM (CEST) in English.

To join via phone, please register at:
https://webcast.meetyoo.de/reg/f7ngieeBvHNo

You will then receive a confirmation email with the telephone number, access code and PIN to access the call.

The presentation and audio can be accessed via the following webcast link:
https://www.webcast-eqs.com/formycon-2024-q1

Following a short presentation, the Executive Board will be available to answer analysts’ questions. A recording of the conference call can subsequently be accessed via the Formycon website at: https://www.formycon.com/en/investor-relations/facts-figures/

Formycon in dialogue

In addition, representatives of the Executive Board will participate in the following international investor conferences in the coming weeks:

May 13 – 15, 2024
Equity Forum Frühjahrskonferenz 2024
Dr. Stefan Glombitza (CEO)
Frankfurt/Main

May 15 – 17, 2024
Hauck Aufhäuser Stockpicker Summit
Enno Spillner (CFO)
Kitzbühel

May 21 – 23, 2024
Berenberg European Conference
Enno Spillner (CFO)
New York City

June 03, 2024
mwb Research Roundtable
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO), Nicola Mikulcik (CBO), Dr. Andreas Seidl (CSO)
Virtual

June 05 – 06, 2024
Jefferies Global Healthcare Conference NYC
Enno Spillner (CFO)
New York City

June 06 – 07, 2024
Warburg Highlights
Dr. Stefan Glombitza (CEO)
Hamburg

June 25 – 27, 2024
Stifel European Healthcare Summit
Enno Spillner (CFO)
Lyon

Please find our current Events at:
https://www.formycon.com/en/investor-relations/calendar/

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today published audited figures and the annual report for the 2023 financial year and provides an outlook for 2024.

“The growth rates prove it: biosimilars are on a successful path worldwide. And Formycon is not only part of this process, but we are on our way to become a driving force step by step. In 2023, we reached all the operational milestones we had set and therewith laid the foundations for a successful and profitable future. For example, our first biosimilar FYB201 had a remarkable market launch in the US and is gradually entering other countries and regions. We have made important progress in the development of the biosimilar candidates FYB202 and FYB203. For both, we have submitted applications for approval in the US and Europe. We are convinced that these pipeline candidates will generate increasing revenues once on the market. Patients with serious diseases should have access to the best possible therapy. Our goal is to consolidate our position as one of the few pure-play biosimilar developers and to further expand this position in a dynamic growth environment” explained Dr. Stefan Glombitza, CEO of Formycon AG.

Enno Spillner, CFO of Formycon AG, adds: “We have presented excellent financial figures for 2023 and reached or exceeded the guidance. Our positive economic development confirms our strategy to continuously invest in our biosimilar pipeline to ensure the rapid and parallel progress of our projects. For us, 2024 will therefore mark a year of transition and investment underpinning the basis for sustainable growth and report positive EBITDA contributions in the medium term. The biosimilar market is growing rapidly, and we are ideally positioned to utilize this potential.”

Increasing revenue due to milestone payments from the FYB202 project, revenue shares from FYB201 sales, and income from development services

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, revenues were within the guided corridor of between € 75 million and € 85 million. In addition to income from development services for the partnered projects FYB201 and FYB203, 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 directly 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.

Positive EBITDA and adjusted Group EBITDA reflect the Group’s operating performance

Contrary to the original guidance, which was in the range of € -5 million to € -15 million, consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) were positive for the full year 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 2023 deprioritized COVID-19 project FYB207.

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 performance of the business model 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 guided range of € 50 million to € 60 million.

The adjusted Group EBITDA aims to present the total revenue from the FYB201 project, which is partially 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).

Solid Working Capital

As of December 31, 2023, the Formycon Group’s working capital amounted to approximately € 38.9 million (December 31, 2022: € 14.0 million) and included cash and cash equivalents of € 27.0 million (December 31, 2022: € 9.8 million). It was thus above the guidance corridor of between € 15 million and € 25 million. Besides 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, while simultaneously the shareholder loan was redeemed by € 20.0 million.

The years 2023 and 2024 will pave the way for further product launches starting in 2025

The targeted development and the continuous expansion of the biosimilar pipeline forms the foundation for Formycon’s long-term growth and profitability. As planned, Formycon has by the end of 2023 submitted the applications for approval for the two late-stage biosimilar candidates FYB202 (Ustekinumab) and FYB203 (Aflibercept) to the FDA and EMA. From a regulatory perspective, the main focus of 2024 will be the upcoming approval decisions in the USA and Europe for these two promising biosimilar candidates.

In addition, preparations for the start of the clinical development program of FYB206 (pembrolizumab) are almost completed and Formycon plans to reach another important milestone 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 last year 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.

Assuming the expected approvals and market launches as well as out-licensing of its biosimilar candidates, Formycon is aiming for a positive EBITDA in the medium term.

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 anticipated 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 partnered projects FYB201 and FYB203, 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 approval-related milestone payments will not be reflected in full as revenue in 2024.

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. To achieve greater internal value creation, Formycon has made a strategic decision to develop this promising candidate independently up to the completion of the Phase I clinical trial. Due to the capitalization of the costs incurred, the investments will not be reflected in the income statement and therefore not in EBITDA.

Adjusted Group EBITDA for 2024 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 full repayment of the shareholder loan. The working capital is expected to be between € 10 million and € 20 million in 2024, which is due to the investments in the FYB206 project and the full repayment of shareholder loans. The flexible shareholder credit line of up to € 48 million remains in place.

The complete Annual Report 2023 can be found on the Formycon website at Financial Reports.

The Executive Management Board of Formycon AG will discuss the development of the company and the key financial figures for the 2023 financial year in a conference call, which will be broadcasted live on the Internet on April 25, 2024 at 3:00 p.m. (CEST) in English.

To participate, please register at: https://research-hub.de/events/registration/2024-04-25-15-00/FYB-GR

You can take part in the event via your web browser or the Zoom app.

A number of international telephone numbers are available for participation by telephone.

You can find an overview under the following link: https://zoom.us/u/aJj3tcDoQ

To dial in to the event by telephone, please use the webinar ID: 962 8767 3566

After a short presentation, the Executive Management Board will be answering questions from analysts. The conference call will be recorded and can be accessed afterwards on the Formycon website at: https://www.formycon.com/investor-relations/facts-figures/.

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

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

Munich – Formycon AG (FWB: FYB, ‘Formycon’) today announced details of the conference call to release the results of the financial year 2023 on April 25, 2024. The management board will discuss the company’s developments and key financial figures and will provide an outlook for the year 2024. The conference call, which will be broadcasted live on the internet, will take place on April 25, 2024, at 3:00 PM (CEST) in English.

To register for participation, please sign up at:
https://research-hub.de/events/registration/2024-04-25-15-00/FYB-GR

Here you can participate in the event via your web browser or the Zoom app.

For participation via telephone, a list of international phone numbers is available. You can find an overview at the following link: https://zoom.us/u/aJj3tcDoQ
To join the earnings call via telephone, please use the webinar ID: 962 8767 3566

Following a short presentation, the Executive Board will be available to answer analysts’  questions. A recording of the conference call can subsequently be accessed via the Formycon website at: https://www.formycon.com/en/investor-relations/facts-figures/

Formycon in dialogue

In addition, representatives of the Executive Board will participate in the following international investor conferences in the coming weeks:

April 23, 2024
Metzler Small Cap Days
Enno Spillner (CFO)
Frankfurt/Main

April 30, 2024
Jefferies Fireside Chat
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO)
Virtual

May 13 – 15, 2024
Equity Forum Frühjahrskonferenz 2024
Dr. Stefan Glombitza (CEO)
Frankfurt/Main

May 15 – 17, 2024
Hauck Aufhäuser Stockpicker Summit
Enno Spillner (CFO)
Kitzbühel

May 21 – 23, 2024
Berenberg European Conference
Enno Spillner (CFO)
New York City

June 03, 2024
mwb Research Roundtable
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO), Nicola Mikulcik (CBO), Dr. Andreas Seidl (CSO)
Virtual

June 05 – 06, 2024
Jefferies Global Healthcare Conference NYC
Enno Spillner (CFO)
New York City

June 06 – 07, 2024
Warburg Highlights
Dr. Stefan Glombitza (CEO)
Hamburg

Please find our current Events at:
https://www.formycon.com/en/investor-relations/calendar/

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