Formycon Shares
Shares
Creating value with biosimilars
With the commercialization of the next approved biosimilar assets and the continuous expansion of its own development pipeline, Formycon has its sights set on growth and sustainable profitability.
Formycon AG
Share Chart
Basic
Information
| Legal Form | German Stock Corporation (Aktiengesellschaft) |
| Initial Exchange Listing | December 20, 2010 |
| ISIN | DE000A1EWVY8 |
| WKN | A1EWVY |
| Exchange and Market Segment | Regulated Market (Prime Standard) SDAX, TecDAX |
| Trading Venues | Xetra, Berlin, Düsseldorf, Frankfurt, Hamburg, Munich, Stuttgart, Tradegate |
| Share Type | Bearer shares without par value |
| Registered Capital | EUR 17,664,427.00 |
| Shares Outstanding | 17,664,427 Bearer shares |
| Designated Sponsors | Oddo BHF Corporates & Markets AG M.M. Warburg & Co |
Shareholder
Structure
Structure as of November 11, 2024
This overview reflects the voting rights notifications pursuant to §§ 33ff of the German Securities Trading Act (Wertpapierhandelsgesetz – WpHG). The individual notifications can be found here.
Analyst
Ratings
| Analyst | Recommendation | Target price in € | Date of latest Research Report |
|---|---|---|---|
| Berenberg | buy | 32,0 | 03/31/2025 |
| First Berlin | buy | 46,0 | 02/24/2024 |
| Hauck & Aufhäuser | buy | 46,0 | 03/31/2025 |
| H.C. Wainwright | buy | 50,0 | 05/15/2025 |
| Jefferies | Under review | 86,0 | 11/28/2024 |
| Kepler Cheuvreux | buy | 50,0 | 05/20/2025 |
| B. Metzler seel. Sohn & Co. | buy | 35,0 | 04/15/2025 |
| mwb [→ Research Formycon AG] | buy | 50,0 | 05/12/2025 |
| Oddo BHF | Neutral | 38,0 | 02/18/2025 |
| Royal Bank of Canada | Outperform | 51,0 | 05/12/2025 |
| M.M. Warburg & Co | buy | 40,0 | 05/12/2025 |
| Average Target Price | 48,0 | 05/20/2025 |
Formycon is covered and evaluated by the analysts mentioned above. Please note that any opinions, estimates or forecasts regarding Formycon’s performance made by these analysts are theirs alone and do not represent opinions, estimates or forecasts of Formycon or its management. The above reference to the analysts does not imply that Formycon endorses their opinions. Formycon is under no obligation to update or supplement the information provided above and does not guarantee the accuracy or completeness of this list.
Analysten Consensus
■ 24,05 % Santo Holding (Deutschland) GmbH, Thomas Peter Maier
■ 13,26 % Wpart GmbH, Wen.Co Invest GmbH, Peter Wendeln
■ 9,08 % Richter Gedeon Vegyészeti Gyár Nyilvánosan Müködö Rt. (Gedeon Richter)
■ 6,04 % Active Ownership Fund SICAV SIF SCS, Klaus Röhrig, Florian Schuhbauer
■ 5,10 % Detlef und Ursula Spruth
■ 3,28 % Stefan Reichensperger
■ 39,19 % Streubesitz
Blog
Blog
Growth and future of biotechnology: opportunities through biosimilars
Guest article in the Bio Deutschland Yearbook 2024/2025 (in German only)
Enno Spillner
Chief Financial Officer (CEO)
Formycon AG
Vor 20 Jahren war die Biotechnologie-Landschaft in Deutschland noch deutlich überschaubarer und BIO Deutschland begann als kleine Organisation mit relativ wenigen Mitgliedern aus der klassischen roten Biotechnologie. Wie die Branche, hat sich auch der Verband seitdem stark entwickelt und diversifiziert. Auch Formycon als Biosimilar-Spezialist gehört dazu und leistet seinen Beitrag zu Know-how, Investitionen und Wachstum.
Die Biotechnologie in Deutschland steht heute vor drei großen Herausforderungen: einem hohen Innovationsdruck, steigenden Kosten im Gesundheitssystem und unzureichender Finanzierung der Entwicklung. Es gab in den letzten Jahren bedeutende technologische Durchbrüche und viele der heute kommerziell international erfolgreichen Produkte basieren auf deutscher Innovationskraft und Technologie.
Fortschritt, Innovationskraft und verbesserte Gesundheitsversorgung führen aber auch zu steigenden Kosten im Gesundheitssystem. Eine logische Antwort darauf sind Biosimilars, die wir bei Formycon entwickeln. Diese biopharmazeutischen Nachfolgeprodukte ermöglichen es, hochwirksame Behandlungen zu deutlich niedrigeren Kosten anzubieten, was sowohl den Patienten als auch den Gesundheitssystemen zugutekommt. Die Bedeutung von Biosimilars wächst rasant und wird in den nächsten Jahren immer entscheidender, um den Zugang zu wirksamen Therapien zu verbessern und diese bezahlbar zu machen.
Die Entwicklung von Biosimilars ist komplex und erfordert jahrelange Forschung sowie hohe Investitionen bis zu ihrer Zulassung. Eine große technische und analytische Kompetenz sowie wissenschaftliche und regulatorische Expertise sind notwendig, um diesen Prozess erfolgreich zu meistern. Trotz der hohen Entwicklungskosten profitieren Biosimilar-Entwickler nicht von Exklusivitätsrechten, was den Margendruck erhöht. Deshalb müssen diese Unternehmen besonders effizient arbeiten, um im direkten Wettbewerb bestehen zu können. In einem Umfeld, in dem es keinen Patentschutz gibt, zählt jeder Tag und jeder Euro.
Der Erfolg eines Biosimilar-Unternehmens und insbesondere von Formycon basiert auf einem erfahrenen Entwickler-Team und einer klaren strategischen Planung bei der Auswahl der Kandidaten. Die enge Abstimmung zwischen Forschung, Entwicklung, Regulatorik und Vermarktung ist entscheidend, um ein Biosimilar erfolgreich auf den Markt bringen zu können. Bei Formycon haben wir gezeigt, wie wichtig es ist, auf die richtige Kombination aus Know-how und Erfahrung zu setzen. Unser Team hat sich in den letzten fünf Jahren auf rund 240 Mitarbeitende verdoppelt und wir haben all unsere geplanten Meilensteine erreicht: darunter die Zulassung und erfolgreiche Markteinführung unseres ersten Biosimilars in globalen Schlüsselmärkten sowie Zulassungen der FDA und EC für weitere Biosimilars in diesem Jahr.
Für Formycon ist die Auswahl der Partner – vor allem in den Bereichen Herstellung und Vermarktung – in diesem intensiven Wettbewerbsumfeld extrem wichtig, um Marktanteile und Margen zu sichern und den Markt mit hochqualitativen Biosimilars zu durchdringen. Die erfolgreiche Vermarktung und daraus resultierende Produktumsätze sichern in den nächsten Jahren einen Teil der Investitionen in unsere vielversprechende und diverse Pipeline von Biosimilars der nächsten Generation, wie z. B. für die dieses Jahr gestartete Entwicklung von Pembrolizumab.
Unser Erfolg basiert auf einer Mischung aus wissenschaftlicher Expertise, Marktintelligenz, Agilität, Flexibilität und Kostensensitivität, um im hart umkämpften Biosimilar-Markt zu wachsen und langfristig zu bestehen. Dies gilt auch für die deutsche Biotechnologie-Branche, die einem starken internationalen Wettbewerb ausgesetzt ist. Umso wichtiger ist die Arbeit von BIO Deutschland, die Interessen zu bündeln und sich für besser Rahmenbedingungen sowie Unterstützung in Politik und Öffentlichkeit einzusetzen. Biotech ist Zukunftstechnologie, die auch in den nächsten 20 Jahren Innovationen vorantreiben wird, um die Herausforderungen der Gesundheitssysteme zu meistern.
An Interview with our Executive Board
13. August 2024
Formycon is regarded as a “pure play” biosimilars company. What exactly does this mean?
Dr. Stefan Glombitza
Chief Executive Officer (CEO)
Formycon AG
Dr. Stefan Glombitza, Chief Executive Officer: „Formycon is a globally operating, independent specialist in the development of biosimilar drugs. We aim to firmly establish our company as leader in the growing biosimilars segment and partner of choice for the major pharmaceutical names with their strength and reach in sales and marketing. For us, being a “pure play” specialist means complete and absolute focus on our capabilities and excellence spanning all phases of biosimilars development, from the process of selecting biosimilar candidates all the way through to regulatory approval.“
What makes you so confident that biosimilars are a growth market?
Stefan Glombitza: „Three reasons: firstly, the vast combined market size of the biologics which will lose their market exclusivity over the next few years; secondly, the large and ever increasing need for doctors to be able to effectively treat patients; and thirdly, the growing financial strains on the world’s healthcare systems. Because of the high cost of many biologics, it remains true even today that too few patients are being treated with these highly effective drugs at a sufficiently early disease stage. Biosimilars, with their comparable efficacy, represent a cost-effective solution to this global problem. Biosimilars can provide the financial relief so that as many patients as possible can receive the optimal therapy as early as possible. The “gold standard” for treating serious diseases should not be reserved for just the privileged few.“
Can you give us an example of a disease for which medical needs are not currently being fully met because there is, in fact, an undersupply of biologics?
Stefan Glombitza: „One of many examples is Crohn’s disease, a chronic inflammatory bowel disorder. Even in a rich country like Germany, only about 15% of Crohn’s patients are currently being treated with highly effective biologics.1 In the acute phases of Crohn’s disease, severe inflammatory symptoms often occur for periods of several weeks, severely impacting quality of life for those afflicted, including tremendous psychological stress. The treatment option is there, but it is being used too rarely. We want to change this – in this specific case with FYB202, our candidate biosimilar to Stelara®2, for which we expect EU approval shortly following the CHMP’s positive recommendation.3 As biosimilars like our FYB202 enter the market, competition increases, costs fall, and patient care improves.“
Formycon announced quite a number of development advances over the first six months of this year. Which of these were the highlights for you?
Stefan Glombitza: „At the start of the year, we said: In 2024 we will lay the foundation for the next phase of Formycon’s growth, which will lead us to sustainable profitability over the medium term, through the approval of biosimilars and preparations for their market launch by early 2025. We’re on track for this.
A particular highlight is certainly the FDA’s4 approval of FYB203, our biosimilar to Eylea®5. With this approval for the U.S. market of FYB203 – which, like our FYB201 product, can be used to treat serious retinal diseases such as “wet” age-related macular degeneration and various diabetes-related diseases – we are now even more strongly positioned in the ophthalmology sector.“
What about Formycon’s other biosimilar development projects?
Stefan Glombitza: „We’re coming along very well and in some cases are making progress even faster than anticipated. With the launch of clinical trials in June, we hope to secure a strong market position for FYB206, our candidate biosimilar to Keytruda®6. As a biosimilar to the world’s top-selling drug, the economic importance of this project can hardly be overstated. We see enormous future demand.
As to the FYB202 project which I mentioned before, we expect EU approval as early as the beginning of the fourth quarter of 2024, a few weeks ahead of our original plan, due in no small part to the superb work and quick response times of our development teams. In the United States, we likewise expect FDA approval for FYB202 around the end of September. In addition, we hope to begin work on FYB210, a new biosimilar candidate, in the second half of the year. In other words, you can look forward to more positive news from Formycon over the coming weeks and months.“
Dr. Glombitza mentioned the economic importance of FYB206 to Formycon. What more can you tell us about this?
Dr. Andreas Seidl
Chief Scientific Officer (CSO)
Formycon AG
Dr. Andreas Seidl, Chief Scientific Officer: „With this entry into immuno-oncology, we are opening up an area of active ingredients with extraordinarily large market potential. The IARC7 expects that worldwide cancer cases will continue to increase sharply in the future. The demand for these modern therapies is immense – so there’s a good reason why so many biosimilars are being developed for cancer treatment.“
How can FYB206 help cancer patients?
Andreas Seidl: „With FYB206, or pembrolizumab, we are developing a candidate biosimilar that works by activating the body’s own immune response to fight the tumor. This is a highly promising approach for numerous cancer indications, notably including non-small cell lung cancer and melanoma, a particularly aggressive form of skin cancer. These are, in fact, the two specific indications for which we are currently conducting our clinical trials.“
Top-selling reference drugs generally mean a lot of potential competitors in the biosimilars market space. Where do you see Formycon in this competition?
Andreas Seidl: „The start of clinical trials is a good indicator for comparing our own development progress to that of our competitors. All in all, we can be very satisfied by this metric because it means that we are in the leading tier of biosimilar developers, particularly within the target markets of the United States and Europe.“
So both of these clinical trials are already in progress?
Andreas Seidl: „Yes, the two clinicals studies are being conducted in parallel across several centers in Eastern Europe and Southeast Asia. In mid-June, we launched the Dahlia phase I study, comparing the pharmacokinetics, safety and tolerability of FYB206 with the reference drug Keytruda®. Study participants are patients who have had a malignant melanoma surgically removed.
For the Lotus phase III study, we recruited patients with non-small cell lung cancer and began the actual clinical trials starting from the end of July. The Lotus study compares the safety and efficacy of FYB206 to its reference drug Keytruda®.
I know that a lot is also happening in the area of commercialization. What are Formycon’s current priorities?
Nicola Mikulcik
Chief Business Officer (CBO)
Formycon AG
Nicola Mikulcik, Chief Business Officer: „Our FYB201 product, the biosimilar to Lucentis®8, also known as ranibizumab, is already available in 19 countries worldwide. In the United States and various other markets, we are pleased with the very good market penetration we’ve already achieved, and we are clearly leading in ranibizumab biosimilars. And the market launches are continuing: Most recently, we were able to announce the launch in Saudi Arabia through our commercialization partner MS Pharma. Further approvals and product launches are planned through to 2026, with a particular regional focus on Middle Eastern and Latin American markets.“
How have the European markets been developing?
Nicola Mikulcik: „We are working hard to further expand our market share within Europe. The introduction of pre-filled syringes to complement the currently available vials will play a key role in these efforts. This more convenient dosage form should be available to doctors and eye clinics over the course of the coming year.“
FYB202 and FYB203 are both approaching the commercialization stage. What are the next steps as you prepare for market introduction?
Nicola Mikulcik: „In the case of FYB202, our candidate biosimilar to Stelara®, we’re focusing on the initial market launches together with our marketing partner Fresenius Kabi and working hard to ensure that the product is available in sufficient quantities starting with the United States and Europe.
For our second ophthalmology biosimilar, FYB203, our partner and license holder Klinge Biopharma has concluded an exclusive license and supply agreement with MS Pharma for marketing in the MENA region. MS Pharma is very well positioned throughout this region and has already been successfully introducing our FYB201 product in these markets.
As to the United States and Europe, we expect to conclude corresponding agreements with strong commercialization partners in the second half of the year.“
How is 2024 looking so far from a financial perspective?
Enno Spillner
Chief Financial Officer (CFO)
Formycon AG
Enno Spiller, Chief Financial Officer: „The entry of Gedeon Richter as a strategic investor at the start of the year was a major statement of confidence. For us, this was not only a big success as a transaction but also a validation of our growth path and remarkable achievements over the past few years.
The cash inflow from this transaction of roughly € 83 million has made a significant contribution to our capacity to continue pushing forward with our biosimilar development projects, particularly FYB206, at a consistently rapid pace while also ensuring the highest quality standards.“
In the case of two biosimilar candidates, development is almost complete. What are your expectations for FYB202 and FYB203?
Enno Spillner: „As of now, we are fully on schedule with all of our development projects and are looking forward to the launch of FYB202, our candidate biosimilar to Stelara®, in 2025. Once the global market launch by our commercialization partner Fresenius Kabi is complete, FYB202 will significantly increase Formycon’s sales revenue and help us attain sustainable EBITDA profitability over the medium term. The settlement agreements with Johnson & Johnson have paved the way not only for the U.S. market but also, more recently, for the European and Canadian markets.
We cannot currently give a specific launch date for FYB203, as no agreement has yet been reached with Regeneron, the manufacturer of the reference drug.“
You’ve just issuance an upward revision to your guidance for fiscal year 2024. This is certainly a very positive signal. What were the triggers?
Enno Spillner: „Our current 2024 operating figures are looking good, and everything is going according to plan. Sales and EBITDA are expected to remain within the forecast range. We were pleased to be able to announce a significant upward adjustment to our Adjusted EBITDA forecast due to better-than-expected results from sales of FYB201, which are reported through our investment participation in the Bioeq AG joint venture. These ongoing earnings will make a sustained contribution to our company’s success.“
In summary, it’s clear from everything you’ve said that the first half of 2024 was very successful. Would you say that the path to future success is also clear?
Dr. Stefan Glombitza: „Our path to becoming a globally leading, independent, pure-play biosimilars specialist is supported by a deep personal commitment from the entire #TeamFormycon. This extends to the members of the Supervisory Board with their extensive industry experience not only in Germany but internationally.
On this subject, I would like to once again extend our deepest gratitude to Dr. Olaf Stiller and Peter Wendeln, the two Supervisory Board members who stepped down in June after having done so much to help us to reach where we are today. With remaining members Wolfgang Essler and Klaus Röhrig as well as newly elected members Dr. Bodo Coldewey and Nick Haggar, along with Colin Bond starting from October 2024, we aim to continue Formycon’s successful path but with an increasingly international orientation.
On behalf of the Executive Board, I would like to specially thank our employees. Without the extraordinary efforts of the entire team, the many remarkable successes achieved during the first half of 2024 would not have been possible. We are also grateful to our shareholders for their continued confidence in Formycon and in the work that we do.“
Thank you for taking the time to speak with us!
- Baumgart, Misery, Naeyaert, Taylor: Biological Therapies in Immune-Mediated Inflammatory Diseases: Can Biosimilars Reduce Access Inequities?
- Stelara® is a registered trademark of Johnson & Johnson
-
The opinion of the Committee for Medicinal Products for Human Use (CHMP) of the EMA is the basis for the European Commission’s marketing authorization decision
- US regulatory authority – U.S. Food and Drug Administration
- Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
- Keytruda® is a registered trademark of Merck Sharp & Dohme LLC.
- IARC – International Agency for Research on Cancer
- Lucentis® is aregistered trademark of Genentech Inc.
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In particular, the information on the following web pages is not an offer of securities for sale in the United States. The securities described on those pages have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”). The securities may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act. There will be no public offer of the securities in the United States.
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The documents and information contained on the following websites may only be accessed in the United Kingdom by persons who are “qualified investors” within the meaning of Article 2(e) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017, as amended (“Prospectus Regulation”) as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 who are also (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (“Order”) or (ii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). The securities are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on these materials or this information or any of its content.
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Test 2025
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Eckdaten des Test
| Rechtsform | Aktiengesellschaft |
| Erstnotiz | 20. Dezember 2010 |
| ISIN | DE000A1EWVY8 |
| WKN | A1EWVY |
| Börsensegment | Regulierter Markt (Prime Standard) SDAX, TecDAX |
| Handelsplätze | Xetra, Berlin, Düsseldorf, Frankfurt, Hamburg, München, Stuttgart, Tradegate |
| Aktiengattung | Stückaktien o.N. |
| Grundkapital | 17.664.427,00 Euro |
| Anzahl der Aktien | 17.664.427 Stückaktien |
| Designated Sponsors | Oddo BHF Corporates & Markets AG M.M. Warburg & Co |
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Digitale Zeichnung
FAQ
In drei bis fünf Jahren sehen wir Formycon mit mindestens drei bzw. vier via Kommerzialisierungspartnern international vertriebenen Biosimilar-Produkten im Markt. Darüber hinaus wird unsere Produktpipeline weiter gereift und erweitert sein. Das Unternehmen ist zu einem international renommierten Biosimilar-Player avanciert und gründet auf soliden Finanzzahlen.
Im Gegensatz zu Generika, die durch eine chemische Synthese hergestellt werden und den absolut identischen Wirkstoff wie das ehemals patentgeschützte Präparat enthalten, werden Biosimilars mit Hilfe lebender Organismen produziert. Dies erfolgt meist in Zellkulturen wie beispielsweise in Bakterien, Hefezellen oder Säugetierzellen.1 Aus diesem Grund dauert eine Biosimilar-Entwicklung zwischen 7 und 10 Jahre2 (versus 2 bis 3 Jahre bei Generika3) und erfordert ein Budget zwischen 150 und 300 Mio. Euro3 (versus 5 bis 10 Mio. €3 bei einem Generikum).
Quellen:
1 Was sind eigentlich Biosimilars?
2 IQVIA Assessing the Biosimilar Void.
3 Schätzung des Unternehmens; Entwicklungszeiten und -kosten sind
je nach Indikation und Wirkstoffgruppe sehr unterschiedlich.
Unsere wichtigsten Assets sind unsere Pipelineprojekte, denn sie schaffen Werte. Daher wird unser Fokus auch weiterhin auf dem Ausbau der Plattform liegen. Wir planen derzeit alle 12 bis 18 Monate einen neuen Biosimilar-Kandidaten zu starten.
Wir evaluieren Kandidaten unabhängig von ihrem Indikationsgebiet. Der Schlüssel zu einer nachhaltigen und wertgenerierenden Plattform ist unserer Ansicht nach ein smarter Mix aus Nischen- und Blockbuster-Produkten bei der Auswahl der richtigen Kandidaten.
Die Wahrscheinlichkeit, dass ein Biosimilar erfolgreich zugelassen wird liegt bei etwa 95%, wenn man seine Hausaufgaben exakt und sorgfältig über die gesamte Entwicklungsdauer hinweg gemacht hat. Entscheidender Inflection Point ist der sogenannte Technical Proof of Similarity (TPOS). Ab hier steigt die Wahrscheinlichkeit einer erfolgreichen Zulassung von Phase zu Phase.
Quelle: The path towards a tailored clinical biosimilar development, Schiestl et. al 2020
Formycon setzt bisher KI-Tools ein, um interne Prozesse zu beschleunigen und effizienter zu gestalten. Auch bei der Produktentwicklung kann KI eingesetzt werden, insbesondere bei der effizienten Auswahl von Hilfsstoffen in der Formulierungsentwicklung und Optimierung der Stabilität von Formulierungen. Ebenso nutzen wir KI, um bessere Prognosen aus unseren Daten erhalten zu können. KI wird in Zukunft sicher eine noch größere Rolle in der Diagnostik spielen, sowohl im Rahmen von klinischen Studien als auch in der klinischen Praxis.
Im Vergleich zu großen Pharmaunternehmen sind wir in der Lage wie ein agiles Schnellboot zu agieren und uns den aktuellen Gegebenheiten schnell und wendig anzupassen. Das Besondere im Biosimilar-Bereich ist, dass Mitbewerber immer auch potenzielle Partner sein können. Was Formycon auszeichnet, sind die ausschließlich auf Biosimilars fokussierten Expert:innen, die bereits sehr viele Jahre Erfahrung in der Entwicklung und Zulassung von Biosimilars gesammelt haben und sämtliche Chancen und Herausforderungen entlang der Wertschöpfungskette bestens kennen. Hinzu kommt, dass es weit über 200 biologische Wirkstoffe gibt und kein Unternehmen all diese Wirkstoffe selbstständig entwickeln kann, auch die großen Pharmakonzerne nicht. Daher werden wir auch für diese stets ein attraktiver Partner sein.
Die Entwicklung dieser Arzneimittelklasse spricht klar für einen weiteren Uptake und eine weitere Etablierung von Biosimilars. Das zeigen die Einsparungen, die Biosimilars in den letzten Jahren erzielt haben. Im Global Use of Medicines Report von IQVIA wird prognostiziert, dass Biosimilars bis zum Jahr 2027 weltweit Einsparungen in Höhe von 290 Mrd. US-Dollar generieren werden. Diese Kosteneinsparungen eröffnen den Gesundheitssystemen an anderen Stellen wiederum mehr finanziellen Spielraum, weshalb sie einen wichtigen Beitrag zu einer nachhaltigen Gesundheitsversorgung leisten.
FYB201 wird unter dem Handelsnamen Ongavia® in Großbritannien, Ranopto® in Kanada und Ranivisio® in Europa sowie weiteren Ländern von Teva Pharmaceuticals Ltd. vertrieben. In den USA wird Cimerli® von Sandoz vermarktet und in der MENA-Region durch MS Pharma unter den Handelsnamen Uptera® und Ravegza®.
Für FYB202/Otulfi® wird unser Kommerzialisierungspartner für die globalen Schlüsselmärkte Fresenius Kabi sein.
Für FYB203 und weitere Biosimilar-Kandidaten wurden noch keine Kommerzialisierungspartnerschaften veröffentlicht.
Wir sehen uns als R&D Powerhouse mit einer voll skalierbaren Biosimilar-Entwicklungsplattform und fühlen uns in dieser Rolle sehr wohl. Dennoch ist Formycon auf Wachstum ausgerichtet, um sich als globaler Player im Bereich der Biosimilars zu etablieren. Hierzu gehört grundsätzlich auch die Prüfung von Opportunitäten anorganischen Wachstums entlang der Wertschöpfungskette.
Formycon ist ein auf Wachstum ausgerichtetes Unternehmen mit aktuell einem Produkt im Markt. Demnach ist es im Sinne einer nachhaltigen und wertschöpfenden Unternehmensentwicklung wahrscheinlich, dass wir die Rückflüsse in bestehende und neue Entwicklungsprojekte re-investieren werden und vorerst nicht planen, eine Dividende auszuschütten.
Kontakt
Formycon AG
Investor Relations Hotline: 089 864 667 112
E-Mail: ir@formycon.com
Bond 2025
Bond 2025
Invest in the potential of biosimilars –
for a healthy portfolio
Formycon intends to use the corporate bond to advance its growth strategy – in particular by consequently progressing its ongoing biosimilar projects and further optimizing its biosimilar platform.*
The biosimilars
growth market
The global biosimilar market has been growing dynamically for years and offers enormous potential: for better access to important medicinal products worldwide, for relieving the burden on healthcare systems, and for a company highly specialized in biosimilars such as Formycon.
By 2030, more than 25 blockbuster biological drugs with a total annual market value of around US$130 billion will lose their exclusivity, paving the way for biosimilars. Competition from biosimilars is driving down drug prices. This has a positive impact on access to medicines: more patients can be treated with biological therapies. At the same time, there is significant potential for healthcare systems to reduce costs. As a result, the market for biosimilars is consistently achieving double-digit growth rates in many parts of the world.
Start benefiting from the growing biosimilars market!
*The approval of the prospectus by the Commission de Surveillance du Secteur Financier (CSSF) should not be understood as an endorsement of the securities offered. Potential investors are advised to read the prospectus before making an investment decision in order to fully understand the potential risks and opportunities associated with investing in the securities. The legally binding securities prospectus is available here.
Key terms of the
2025 bond
| Issuer | Formycon AG, Planegg-Martinsried, Germany |
| Issuer Volume | EUR 70,000,000 |
| ISIN / WKN | NO0013586024 / A4DFJH |
| Interest Rate | 3-months EURIBOR plus 7.0 % p.a. |
| Issue Price | 100 % |
| Denomination | EUR 1,000 |
| Interest Payment | Quarterly, first payment on October 9, 2025 |
| Term | Four years, July 9, 2025 to July 9, 2029 |
| Redemption Date | Due on July 9, 2029 |
| Status | Senior unsecured |
| Covenants | Includes restrictions on distributions, liquidity maintenance, and quarterly financial reporting |
| Stock Exchange Segment | Open Market (Freiverkehr) of the Frankfurt Stock Exchange, Quotation Board; admission to Euronext ABM (Oslo Børs) planned within six months |
| Issue / Value Date | July 9, 2025 |
| Joint Lead Manager | IKB Deutsche Industriebank AG, Pareto Securities AS, Frankfurt Branch |
Important investor information
Ways to purchase the bond
During the offer period, the following subscription options are available to interested investors:
Subscription via the Frankfurt Stock Exchange:
From June 20, 2025, until June 27, 2025, 12:00 CEST an additional subscription option is available via Deutsche Börse AG’s DirectPlace. When using DirectPlace, investors can place purchase orders via their house bank or custodian bank on the Frankfurt Stock Exchange during the subscription phase.
Further information on the two subscription options can be found in the FAQ (available in German only).
Contact
Formycon AG
Uplisting
Uplisting
Formycon moves to the Prime Standard
of the Frankfurt Stock Exchange
Formycon has been listed in the “Scale” segment of the Frankfurt Stock Exchange since 2012. By moving to the Prime Standard in November 2024, Formycon is aiming to improve its positioning towards investors and the international capital market.
"Over the past years, we’ve established Formycon as an internationally recognized, independent specialist for the development of biosimilars. Following FYB201 - which is now available in 20 countries and the leading Lucentis® biosimilar in most markets – FYB202 and FYB203 will offer attractive therapeutic options for many patients and markets. This promising operational business development underlines the development potential of our company and forms the basis for the planned uplisting to a higher stock market segment, which sends a strong signal for our presence on the capital market."
--
Dr. Stefan Glombitza
Chief Executive Officer
"We have been preparing intensely for this step over the past months, and we are thrilled to announce this important milestone for Formycon. With a market capitalization of approximately 870 million euros, the company has reached a stage of growth and maturity that has significantly increased interest from international and institutional investors. Moving to the Prime Standard was essential to provide this investor group—and our existing shareholders—with enhanced access to Formycon’s stock. Looking ahead, this transition also opens the door to potential inclusion in one of Deutsche Börse’s select indices, which would further boost the stock’s visibility and appeal."
--
Enno Spillner
Chief Financial Officer
Photos Bellringing Event: martinjoppen.de
„We have been preparing intensely for this step over the past months, and we are thrilled to announce this important milestone for Formycon. With a market capitalization of approximately 870 million euros, the company has reached a stage of growth and maturity that has significantly increased interest from international and institutional investors. Moving to the Prime Standard was essential to provide this investor group — and our existing shareholders — with enhanced access to Formycon’s stock. Looking ahead, this transition also opens the door to potential inclusion in one of Deutsche Börse’s select indices, which would further boost the stock’s visibility and appeal.“
Enno Spillner, CFO of Formycon AG.
The prospectus required for the uplisting is expected to be available here from November 8, 2024 after approval by the Federal Financial Supervisory Authority (BaFin).
Prospectus
(english)
Summary
(english/german)
About Formycon
About Formycon
Commercial Stage Biosimilar Developer
Through our biosimilar development projects, Formycon creates not only highly effective, more affordable biologic drugs for patients but also long-term value for its investors. Biosimilars are a new class of medicines with a very promising future, and our product candidates are targeted at multi-billion-dollar markets.
Equity Story
Focus on What Matters Most – Our Biosimilar Platform
Formycon is an established, successful, and independent pure-play biosimilar company specializing in the development of cost-effective follow-on products for complex biopharmaceutical medicines. In the rapidly growing biosimilar market, we are committed to expanding and advancing our scalable biosimilar platform. Currently, this platform includes three approved biosimilars for ophthalmology and immunology indications, providing millions of patients worldwide with access to essential and affordable therapies. Additionally, we are developing four next-generation biosimilar candidates, with more to follow.
Expertise, Agility, and Flexibility as the Recipe for Success
As a pure-play biosimilar company, Formycon holds a distinct competitive advantage. Our focused strategy, agile development processes, and strong partnerships allow us to efficiently develop high-quality follow-on products and quickly adapt to market changes. This flexibility, combined with our high level of scientific expertise, positions us as a reliable and preferred partner in the highly regulated biopharma market. Our goal is to meet the growing global demand for biosimilars and ensure long-term value creation through a diversified portfolio and strong partnerships.
Strong Partnerships for Economic Success
Strategic partnerships with established manufacturing and commercialization partners are critical to the economic success of our biosimilars. In manufacturing, we select the most suitable partner for each of our biosimilars to ensure a cost-efficient and competitive production process. For global distribution, we form commercialization partnerships with leading pharmaceutical companies such as Fresenius Kabi, Sandoz, and Teva. Thanks to this hybrid business model, we have laid a solid foundation for continuous revenue streams and further growth.
Participate in Growth with Us as Biosimilar Market Specialists
For investors, Formycon’s pure-play approach offers an attractive opportunity to benefit from the dynamic biosimilar market. We develop products that meet the needs of various stakeholders. In addition to patients, doctors, and healthcare systems that directly benefit from the use of biosimilars, pharmaceutical companies also seek our biosimilars to expand their product portfolios in distribution.
With our recent uplisting to the Prime Standard of the Frankfurt Stock Exchange, Formycon has gained significance in the international capital markets. Our solid financial structure and experienced management team provide a reliable foundation for further growth and a strong market position in key global markets.
FAQ
In three to five years, we envision Formycon with at least three or four biosimilar products distributed internationally through commercialization partners. Beyond that, our product pipeline will have matured further and expanded. The company will have established itself as a globally renowned player in biosimilars, grounded in solid financials.
Unlike generics, which are chemically synthesized and contain the exact same active ingredient as the originally patented drug, biosimilars are produced using living organisms. This is usually done in cell cultures, such as bacteria, yeast cells, or mammalian cells1. This is why biosimilar development takes between 7 to 10 years2 (compared to 2 to 3 years for generics3) and requires a budget of between 150 to 300 million euros3 (compared to 5 to 10 million euros for a generic3).
Sources:
1 What are biosimilars?
2 IQVIA Assessing the Biosimilar Void.
3 Company estimates; development times and costs vary greatly
depending on the indication and type of active ingredient.
Our most valuable assets are our pipeline projects, as they create value. Therefore, our focus will remain on expanding our platform. Currently, we plan to launch a new biosimilar candidate every 12 to 18 months.
We evaluate candidates independently of their therapeutic area. In our view, the key to a sustainable and value-generating platform is a smart mix of niche and blockbuster products in selecting the right candidates.
The likelihood of a biosimilar receiving approval is around 95%, provided that development has been conducted with precision and care throughout. The decisive inflection point is known as the “Technical Proof of Similarity” (TPOS). From this stage onward, the probability of successful approval increases with each phase.
Source: “The Path Towards a Tailored Clinical Biosimilar Development,” Schiestl et al., 2020
Formycon uses AI tools to speed up and streamline internal processes. AI can also be used in product development, particularly for the efficient selection of excipients in formulation development and for optimizing formulation stability. Additionally, we use AI to generate better forecasts from our data. In the future, AI will undoubtedly play an even larger role in diagnostics, both within clinical trials and in clinical practice.
Compared to large pharmaceutical companies, we are able to operate like an agile speedboat, adapting quickly and flexibly to current conditions. In the biosimilar field, it’s unique that competitors can also be potential partners. What sets Formycon apart are our experts exclusively focused on biosimilars, with many years of experience in the development and approval of biosimilars, and who thoroughly understand all opportunities and challenges across the value chain. Furthermore, there are over 200 biological active ingredients, and no company, not even large pharmaceutical companies, can develop all of them independently. This makes us an attractive partner for them as well.
The development of this class of drugs clearly points to further uptake and establishment of biosimilars. This is evidenced by the cost savings that biosimilars have achieved in recent years. IQVIA’s Global Use of Medicines report projects that biosimilars will generate global savings of $290 billion by 2027. These savings provide healthcare systems with more financial flexibility in other areas, making biosimilars an essential contribution to sustainable healthcare.
FYB201 is distributed under the brand name Ongavia® in the UK, Ranopto® in Canada, and Ranivisio® in Europe and other countries by Teva Pharmaceuticals Ltd. In the U.S., Cimerli® is marketed by Sandoz, and in the MENA region, MS Pharma markets it under the brand names Uptera® and Ravegza®.
For FYB202/Otulfi®, our commercialization partner for key global markets is Fresenius Kabi.
For FYB203 and other biosimilar candidates, no commercialization partnerships have been announced yet.
We see ourselves as an R&D powerhouse with a fully scalable biosimilar development platform and are very comfortable in this role. However, Formycon is growth-oriented and aims to establish itself as a global player in biosimilars. This fundamentally includes evaluating opportunities for inorganic growth along the value chain.
Formycon is a growth-oriented company with currently only one product on the market. Therefore, to support sustainable and value-generating company development, we are likely to reinvest returns into existing and new development projects, and we do not currently plan to pay a dividend.
