Archives Press Releases

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge”) announce that the European Medicines Agency (“EMA”) has accepted the marketing authorization application (“MAA”) for FYB203, a biosimilar candidate to Eylea®¹ (Active Ingredient: Aflibercept), for review.

Aflibercept is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases. Around 67 million people in Europe are affected by AMD^[[i]]. Due to current demographic trends, this number is expected to continue to rise in the coming years. In most cases, intravitreal injections with the VEGF inhibitor Aflibercept can significantly slow down or even stop the loss of vision caused by the neovascular form of AMD.

“The experience of recent years shows that both patients and healthcare systems benefit from biosimilar competition. With the recent EMA acceptance for our ophthalmological biosimilar candidate FYB203, we are an important step closer to providing another effective treatment option – in addition to our already launched biosimilar FYB201 (ranibizumab) – to the many patients affected by severe retinal diseases in Europe”, says Formycon CEO Dr. Stefan Glombitza.

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

[i] Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis; Li JQ, Welchowski T, Schmid M, et al. British Journal of Ophthalmology 2020;104:1077-1084. http://dx.doi.org/10.1136/bjophthalmol-2019-314422

Munich, Amsterdam, Zug, Toronto – Formycon AG, Polpharma Biologics Group BV, Bioeq AG and Teva Canada Ltd. jointly announce that Health Canada has granted the “Notice of Compliance” (NOC) for Ranopto^®1 (Ranibizumab), a biosimilar to Lucentis^®2, for the treatment of several serious retinal diseases in Canada.

Ranopto^® is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO).

FYB201/Ranopto^® was developed by Bioeq, a Joint Venture between Formycon and Polpharma Biologics. Mid 2021, Teva Pharmaceutical Industries Ltd. (“Teva”) entered into a strategic partnership for the exclusive commercialization of FYB201 in Canada, Europe and selected other countries. Commercial launch by Teva Canada Ltd. is expected to start in the first quarter of 2024.

AMD is caused by excessive growth of blood vessels in the retina. Ranibizumab inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels in the retina. In developed countries AMD is the most common cause of severe visual impairment or blindness. The risk of being affected increases with age. In Canada, approximately 2.5 million people are affected by AMD with nearly 180,000 experiencing vision loss[i].

“After successful launches in the U.S., Europe and countries of the MENA region, we are very pleased that – together with our partner Teva – we are now able to provide a highly effective and affordable treatment option to patients in Canada with severe retinal diseases. With the second highest per capita sales and third highest per capita consumption in the OECD, anti-VEGF therapies in Canada have been a significant burden on public drug plans in the past. With our biosimilar, we can contribute to more competition and cost efficiency in this important therapeutic area”, says Dr. Stefan Glombitza, CEO of Formycon AG.

“The approval in Canada underlines the excellent work we have done together with our partners in the development of FYB201/Ranopto^®. It brings us a big step closer to our goal of improving therapy access for people with nAMD and other prevalent eye diseases worldwide, and thereby contributing to a better quality of life for millions of people affected”, says Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics Group.

“Teva Canada is very pleased along with our partners to launch Ranopto^®. This marks an important milestone for our growing biosimilar portfolio and a new treatment option for Canadian patients with severe retinal disease as well as healthcare professionals”, says Michael Sine, General Manager Teva Canada.

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¹Ranopto® is a registered trademark of Bioeq AG.
²Lucentis® is a registered trademark of Genentech, Inc.

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

Munich/Martinsried – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced that members of the Management Board plan to be present at the following investor conferences in the first quarter of 2024:

J.P. Morgan Healthcare Conference
January 09 – 12, 2024 / San Francisco
1×1 Meetings (Dr. Stefan Glombitza, CEO & Enno Spillner, CFO)
Investor meeting requests are welcome via this Link.

Oddo BHF Forum
January 15 – 16, 2024 / virtual
1×1 Meetings (Enno Spillner, CFO)

UniCredit & Kepler Cheuvreux German Corporate Conference
January 17, 2024 / Frankfurt am Main
1×1 Meetings (Enno Spillner, CFO)

J.P. Morgan Annual Pan‐European Small/Mid‐Cap CEO Conference
March 12 – 14, 2024 / London
1×1 Meetings (Dr. Stefan Glombitza, CEO & Enno Spillner, CFO)

Jefferies Pan‐European Mid‐Cap Conference
March 19 – 21, 2024 / London
1×1 Meetings (Enno Spillner, CFO)

Metzler Small Cap Days
April 22 – 24, 2024 / Frankfurt am Main
1×1 Meetings (Enno Spillner, CFO)

For further information please visit the Formycon Website at
https://www.formycon.com/en/investor-relations/calendar/

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Biologics License Application (“BLA”) for FYB202, a proposed biosimilar candidate to Stelara^®1.

FYB202 is a human monoclonal antibody that targets interleukin 12 and interleukin 23 for the treatment of immune-mediated disorders. The reference medicinal product Stelara^® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis.

“The FDA file acceptance for our Stelara^® biosimilar candidate FYB202 underlines the great expertise and capabilities of #TeamFormycon. Following the acceptance of our application by the EMA at the end of September, this represents another major step for us towards providing a high-quality, safe and affordable treatment option for patients with severe chronic inflammatory diseases. Thus, we are right on track with all important milestones we wanted to achieve in 2023,” says Formycon CEO Dr. Stefan Glombitza.

“Today’s BLA submission acceptance underscores Fresenius Kabi and Formycon’s unwavering commitment to improving patient access to high-quality biopharmaceuticals worldwide and to bring the ustekinumab biosimilar candidate FYB202 one step closer to patients and healthcare providers in the United States. In line with our Vision 2026, we remain dedicated to advancing healthcare solutions for the benefit of patients while expanding our immunology & oncology portfolio.“, says Dr. Michael Schönhofen, President Fresenius Kabi Biopharmaceuticals

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

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (Klinge) announce that the marketing authorization application (MAA) for FYB203, a biosimilar candidate for Eylea®¹ (Active ingredient: Aflibercept) has been submitted to the European Medicines Agency (EMA).

Eylea® 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 the first nine months of 2023, Eylea reached global sales of around US$ 7 billion^[[i]], underlining its status as the currently best-selling drug in the field of anti-VEGF therapies.

“Our latest MAA submission once again demonstrates the high performance and reliability of the entire #TeamFormycon. We are very pleased that with FYB203 we have filed our second biosimilar candidate in the ophthalmology space that is likely to become even more important in the coming years in light of the aging population.”, says Formycon CEO Dr. Stefan Glombitza.

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¹ Eylea^® is a registered Trademark of Regeneron Pharmaceuticals Inc.

[i] https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-third-quarter-2023-financial-and-operating

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today announced the financial results and corporate development of Formycon Group for the first nine months of the 2023 financial year.

On-track development of biosimilar candidates and successfully progressing market establishment of FYB201 are drivers of the company’s success

The successful progress in the development of the biosimilar pipeline forms the basis for Formycon’s long-term and sustainable growth. The submission of the regulatory applications for the two late-stage biosimilar candidates FYB202 (ustekinumab) and FYB203 (aflibercept) to the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”) is expected to be realized as planned by the end of 2023.

Preparations for the start of the clinical development program for the biosimilar candidate FYB206 (pembrolizumab) are already well advanced. The start of the clinical phase is still scheduled for the course of 2024. In addition, Formycon is investing sustainably in the further expansion of its biosimilar pipeline and significantly expanded its product portfolio last year with the start of development of the two new biosimilar candidates FYB208 and FYB209.

Significant success payments from FYB202 project and participation from FYB201 marketing proceeds are reflected in rising revenue – EBITDA continues to be positive

The Group’s key financial figures continued to develop very positive as of September 30, 2023: The Group’s revenue rose to a total of € 60.2 million in the first nine months of the year, more than doubling (+113%) compared to the same period of the previous year (Q3/2022: € 28.2 million). Consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to € 5.2 million (Q3/2022: € -10.9 million) and were mainly due to the increase in revenue.

A significant part of the revenue resulted from the success payments under the commercialization partnership with Fresenius Kabi from the FYB202 project. The marketing of the ranibizumab biosimilar, which is now available in a total of 16 countries worldwide, is also contributing to an increase in revenue and net earnings contributions.

Primarily in the U.S., sales partner Coherus BioSciences, Inc. significantly increased net sales of CIMERLI®¹ to US$ 40.0 million in the third quarter of 2023 compared to US$ 26.7 million[i] in the second quarter and US$ 6.2 million[ii] in the first quarter. Product sales have exceeded 100,000 doses since launch on October 3, 2022 in the U.S., and CIMERLI® achieved a 29% share of the overall ranibizumab market in the U.S. in the third quarter of 2023.[iii]

As a result, direct license revenue for Formycon increased to a total of € 2.2 million in the first nine months of the year (H1/2023: € 1.2 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 reflected in the topline, but below EBITDA. In the third quarter, the at-equity result amounted to € 4.4 million. As at the reporting date of September 30, it totaled € -1.7 million for 2023. Due to the market launches in additional territories by the end of 2023 and in 2024, Formycon expects further increases in revenue and net earnings contributions from product marketing by the respective commercialization partners.

Group net result rises to € 74.3 million due to one-off, non-cash adjustment in the context of financial income

The group net result as of the reporting date is impacted by the effects of the ATHOS transaction from 2022, which had an impact on earnings but not liquidity. As part of a planning update in the FYB201 project, an adjustment of the fair value valuation and the earn-out obligation to ATHOS KG was made, resulting in a corresponding decrease in the fair value of the earn-out obligation and a simultaneous impairment of the shares in Bioeq AG. These two effects result in total accounting financial income and a correspondingly higher financial result for the Formycon Group, which led to a net result of € 74.3 million (Q3/2022: € 61.1 million including one-off effect).

As expected, the Formycon Group’s cash and cash equivalents amounted to around € 35.6 million as of September 30, 2023, compared to € 9.8 million as of December 31, 2022. In order to accelerate the operational progress and the further development of the biosimilar pipeline, particularly in the FYB206 Project, and to ensure that it is in line with the company’s planning, Formycon is currently evaluating possible financing options by raising debt capital.

Formycon Group forecast for the full year 2023 adjusted at net result level – revenue and EBITDA unchanged

For 2023, the Formycon Group continues to expect revenues of between € 75.0 million and € 85.0 million, which will mainly result from marketing proceeds from the Lucentis^®2 biosimilar (FYB201) Ranivisio®³/ Ongavia®⁴ /CIMERLI® and success payments for the FYB202 project as well as from development services for the out-licensed FYB203 project and the FYB201 project developed in partnership. The forecast for key operating figures such as EBITDA is also expected to remain in the range of € -5.0 million to € -15.0 million due to further R&D investments in the product pipeline.

Due to the valuation effect described above, group net income is adjusted upwards as part of the significant increase in financial income and is now expected to be in a range between € 50.0 million and € 60.0 million compared to € -20.0 million and € -30.0 million for 2023.

“The financial result for the first nine months is very positive for Formycon and we can be very satisfied with both the operational and financial development of the company to date. The consistent development of our pipeline and the operational excellence of the entire team are essential value drivers of our company. We will continue to invest dynamically in our biosimilar pipeline in order to accelerate the rapid progress of our assets in the best possible way. At the same time, we want to maintain our high-quality standards. This approach, which is focused on agility, excellence and flexibility, makes us a competitive and focused participant in the growing biosimilar market,” comments Enno Spillner, CFO of Formycon AG.

The Management Board of Formycon AG will discuss the development of the company as well as the most important financial figures for the first nine months of 2023 during a conference call.

The conference call, which will be streamed live online, will be held in English on November 13, 2023 at 3:00 p.m. (CET).

To participate by phone, please register at:
 https://webcast.meetyoo.de/reg/7EM0LU0WyIdU

You will then receive a confirmation email with the phone number, as well as the 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-2023-q3

Following a short presentation, the Board of Directors will be available for direct questions. The conference call will be recorded and will be available afterwards via the Formycon website at: https://www.formycon.com/investoren/fakten-zahlen/.

1)         Cimerli® is a registered trademark of Coherus BioSciences, Inc.
2)         Lucentis® is a registered trademark of Genentech Inc.
3)         Ranivisio® is a registered trademark of Bioeq AG
4)         Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.

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^[i] Coherus BioSciences Reports Third Quarter 2023 Financial Results and Business Highlights | Coherus BioSciences, Inc.

^[ii] Coherus BioSciences Reports First Quarter 2023 Financial Results and Business Highlights | Coherus BioSciences, Inc.

^[iii] Coherus BioSciences Reports Third Quarter 2023 Financial Results and Business Highlights | Coherus BioSciences, Inc.

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) will introduce the company’s development and nine-month figures 2023 in a conference call on November 13, 2023.

The conference call, streamed live on the internet, will be held in English on November 13, 2023 at 3:00 p.m. (CEST).

To join via phone, please register at:
https://webcast.meetyoo.de/reg/7EM0LU0WyIdU

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 link:
https://www.webcast-eqs.com/formycon-2023-q3

Following a short presentation, the Executive Board will be available for direct 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:

November 14 – 16, 2023

Jefferies London Healthcare Conference 2023

Dr. Stefan Glombitza (CEO), Enno Spillner (CFO)

London

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November 27 – 29, 2023

German Equity Forum 2023

Enno Spillner (CFO)

Frankfurt a. M.

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

Munich – Formycons commercialization partner Coherus BioSciences, Inc. announced that sales of CIMERLI® (ranibizumab-eqrn) to retinal specialists in the United States of America (“U.S.”) have exceeded 100,000 doses since commercial launch on October 3, 2022.

CIMERLI® is the first and only FDA-approved biosimilar interchangeable with Lucentis®³ for both strengths. In August 2023, CIMERLI® achieved 25% market share of the ranibizumab market, making it the number one ranibizumab biosimilar in the United States (“U.S.”).

“This is a great achievement and underlines again that biosimilars are an important treatment option for severe retinal diseases. With FYB201, we have developed an excellent product, which has now become number one ranibizumab biosimilar in the U.S. market. We are also fully on track with our next two late-stage assets. File Acceptance by the U.S. Food and Drug Administration (“FDA”) for FYB203 (Eylea®⁴ biosimilar candidate) has already been reported and submission to the European Medicines Agency (“EMA”) is also planned in the course of this year. The same applies for FYB202 (Stelara®⁵ biosimilar candidate) which has already been accepted by the EMA and is fully on schedule regarding FDA submission,” commented Dr. Stefan Glombitza, CEO of Formycon AG.

¹⁾CIMERLI® is a registered Trademark of Coherus BioSciences, Inc.
²⁾ IQVIA NSP Data August 2023
³⁾ Lucentis® is a registered Trademark of Genentech Inc
⁴⁾Eylea® is a registered Trademark of Regeneron Pharmaceuticals Inc.
⁵⁾Stelara® is a registered Trademark of Johnson & Johnson

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the European Medicines Agency (“EMA”) has accepted the Marketing Authorization Application (“MAA”) for FYB202, a proposed biosimilar candidate to Stelara^®1.

FYB202 is a human monoclonal antibody that targets interleukin 12 and interleukin 23 for the treatment of immune-mediated disorders. The reference medicinal product Stelara^® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis.

“With the current FYB202 submission we are very proud of having brought our third biosimilar pipeline candidate onto the regulatory pathway. The EMA acceptance of the marketing authorization application brings us one step closer to offering broader access to another affordable and important high-quality biosimilar treatment option for patients with chronic immune-mediated inflammatory diseases in Europe,” commented Dr. Stefan Glombitza, CEO of Formycon AG.

“Today marks another milestone in our journey towards advancing healthcare accessibility and the provision of high-quality, affordable treatment options to patients across Europe. The MAA acceptance for review of biosimilar candidate FYB202 is a testament to the dedication and expertise of our teams and the company’s Vision 2026 growth strategy. At Fresenius Kabi, we believe in the power of biosimilars to transform patient care and contribute to the sustainability of healthcare systems,” said Dr. Michael Schönhofen, Fresenius Kabi President Biopharma.

In February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize the proposed ustekinumab biosimilar (FYB202) in key global markets after successful regulatory approvals.

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