Abivax Establishes an At-the-Market (ATM) Program on Nasdaq

PARIS, France, November 19, 2024 – 10:30PM CET – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the inflammatory response in patients with chronic inflammatory diseases, today announced the implementation of an At-The-Market program (“ATM Program”) allowing the Company to issue and sell, including with unsolicited investors who have expressed an interest, ordinary shares in the form of American Depositary Shares (“ADS”), each ADS representing one ordinary share, nominal value €0.01 per share, of the Company, with aggregate gross sales proceeds of up to $150,000,000 (subject to French regulatory limits and within the limits of the investors’ requests expressed in the context of the program), from time to time, pursuant to the terms of an equity distribution agreement with Piper Sandler & Co. (“Piper Sandler”), acting as sales agent. The timing of any issuances in the form of ADSs will depend on a variety of factors. The ATM Program will be effective for a 3-year period, i.e. until November 19, 2027, unless terminated prior to such date in accordance with the equity distribution agreement or if ADSs representing the maximum gross sales proceeds have been sold thereunder.

A shelf registration statement on Form F-3, including a base prospectus relating to Abivax’s securities and an equity distribution agreement prospectus relating to the ATM Program, was filed with the U.S. Securities and Exchange Commission (“SEC”), but has not yet become effective. The base prospectus provides for the potential sale of ADSs of the Company (including outside of the ATM Program) with aggregate gross sales proceeds of up to $350,000,000 to grant additional flexibility to the Company in connection with its financing strategy. The securities referred to in the registration statement may not be sold, nor may offers to buy them be accepted, prior to the time the registration statement becomes effective.

To the extent that ADSs are sold pursuant to the ATM Program, Abivax currently intends to use the net proceeds (after deduction of fees and expenses), if any, of sales of ADSs issued under the ATM Program primarily for the launch and continuation of clinical programs on obefazimod, and working capital and general corporate purposes, at its discretion.

Piper Sandler, as sales agent, will use commercially reasonable efforts to arrange on the Company’s behalf the sale of ADSs to eligible investors requesting it, consistent with Piper Sandler’s normal sales and trading practices. Sales prices may vary based on market prices and other factors. Only eligible investors (as described in greater detail below) may purchase ADSs under the ATM Program. In any case, the corresponding sales price of the new ordinary shares underlying the ADSs will not be less than the volume weighted-average of the trading prices of the Company’s ordinary shares on the regulated market of Euronext in Paris (“Euronext Paris”) over a period chosen of between three and ninety consecutive trading days prior to the relevant pricing date, subject to a maximum discount to such volume weighted-average price of 10%.

The ADSs and the underlying ordinary shares will be issued through one or more share capital increases without shareholders’ preferential subscription rights under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) and pursuant to and within the limits set forth in the 20^th and 28^th resolutions adopted by the combined shareholders’ general meeting dated May 30, 2024 (or any substitute resolutions, adopted from time to time), i.e., a maximum number of 25,000,000 ordinary shares, representing a maximum potential dilution of approximately 39.5% based on the existing share capital of the Company as of October 31, 2024. The number of underlying ordinary shares to be admitted on Euronext Paris shall represent, over a period of 12 months, less than 20% of the ordinary shares already admitted to trading on said market without a French listing prospectus (such limit being increased to 30% upon entry into force of the Listing Act Regulation[1] on December 4, 2024).

The new ordinary shares to be sold in the form of ADSs would be issued in one or more offerings at the market price of the ADSs at the time of pricing of the considered capital increases.

ADSs under the ATM Program may only be issued to the categories of investors defined in the 20^th resolution adopted by the General meeting of May 30, 2024 (or any similar resolutions that may be substituted for it in the future), comprising (i) French or foreign individuals or legal entities, including companies, trusts or investment funds or other investment vehicles of any kind, investing on a regular basis, or having invested more than one million euros during the 24 months preceding the considered capital increase, (a) in the pharmaceutical sector; and/or (b) in growth stocks listed on a regulated market or a multilateral negotiation system (type Euronext Growth) considered as “micro, small and medium-sized enterprises” in the meaning of annex I to the Regulation (CE) no. 651/2014 of the European Commission of June 17, 2014; and/or (ii) one or more strategic partners of the Company, located in France or abroad, who has (have) entered into or will enter into one or more partnership agreements (such as development, co-development, distribution, and manufacturing agreements) or commercial agreements with the Company (or a subsidiary) and/or companies they control, that control them or are controlled by the same person(s), directly or indirectly, within the meaning of Article L. 233-3 of the French Commercial Code. The new ordinary shares will be admitted to trading on Euronext Paris and the issued ADSs will trade on the Nasdaq Global Market (“Nasdaq”).

On an illustrative basis, assuming the issuance of the full amount of $150 million (all exchange rate translations in this press release are for convenience and based on an exchange rate of €1.00 = $1.0583, the exchange rate reported by the European Central Bank on November 15, 2024) of ADSs under the ATM Program at an assumed offering price of $9.50 per ADS (or €8.87 per ordinary share), the last reported price of the ADSs on Nasdaq on November 15, 2024, a holder of 1.0% of the Company’s outstanding share capital as of the date of this press releases, would hold 0.80% of the Company’s outstanding share capital after the completion of the transaction (calculated on the basis of the number of outstanding shares on the date of publication of this press release).

During the term of the ATM Program, the Company intends to include information in the publication of its half-year and full-year financial reports about its use of the ATM Program during the preceding period and intends to also provide an update after each capital increase under its ATM Program on a dedicated location on its corporate website in order to inform investors about the main features of each issue that may be completed under the ATM Program from time to time.

The shelf registration statement on Form F-3 (including a prospectus) relating to Abivax’s ADSs was filed with the SEC on November 19, 2024. Before purchasing ADSs in the offering, prospective investors should read the prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Piper Sandler, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at +1 (800) 747-3924, or by email at prospectus@psc.com. No prospectus will be filed with the French Autorité des Marchés Financiers (“AMF”) pursuant to Regulation (EU) 2017/1129 of the European Parliament and of the Council dated June 14, 2017, as amended (the “Prospectus Regulation”), since the contemplated share capital increase(s) (for the issuance of the ordinary shares underlying the ADSs) would be offered to qualified investors (as such term is defined in Article 2(e) of the Prospectus Regulation) and fall under the exemption provided for in Article 1(5)(a) of the Prospectus Regulation, which states that the obligation to publish a prospectus shall not apply to admission to trading on a regulated market of securities fungible with securities already admitted to trading on the same regulated market, provided that they represent, over a period of 12 months, less than 20% of the number of securities already admitted to trading on the same regulated market (such limit being increased to 30% upon entry into force of the Listing Act Regulation[2]).

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. In particular, no public offering of the ADSs will be made in Europe.

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About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis.

Contact:

Patrick Malloy
SVP, Investor Relations
Abivax SA
patrick.malloy@abivax.com
+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “intend,” “may,” “would,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the Company’s proposed securities offering and its intended use of proceeds. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development, including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

Disclaimer

This press release does not, and shall not, in any circumstances constitute a public offering nor an invitation to solicit the interest of the public in France, the United States, or in any other jurisdiction, in connection with any offer.

The distribution of this document may, in certain jurisdictions, be restricted by local legislations. Persons into whose possession this document comes are required to inform themselves about and to observe any such potential local restrictions.

This press release is not an advertisement and not a prospectus within the meaning of Regulation (EU) 2017/1129 (the “EU Prospectus Regulation”). This document does not constitute an offer to the public in France (except for public offerings defined in Article L.411-2 1° of the French Monetary and Financial Code) and the securities referred to in this document can only be offered or sold in France pursuant to article L. 411-2, 1° of the French Monetary and Financial Code to (i) qualified investors (investisseurs qualifiés) as defined in Article 2(e) of the EU Prospectus Regulation and/or (ii) a limited group of investors (cercle restreint d’investisseurs) acting for their own account, all as defined in and in accordance with articles L. 411-1, L. 411-2 and D. 411-2 to D. 411-4 of the French Monetary and Financial Code.

With respect to the Member States of the European Economic Area, no action has been undertaken or will be undertaken to make an offer to the public of the securities referred to herein requiring a publication of a prospectus in any relevant Member State. As a result, the securities may not and will not be offered in any relevant Member State except in accordance with the exemptions set forth in Article 1(4) of the EU Prospectus Regulation or under any other circumstances which do not require the publication by the Company of a prospectus pursuant to Article 3 of the EU Prospectus Regulation and/or to applicable regulations of that relevant Member State.

MIFID II product governance / Retail investors, professional investors and ECPs only target market – Solely for the purposes of each manufacturer’s product approval process, the target market assessment in respect of the new shares has led to the conclusion that: (i) the target market for the new shares is retail investors, eligible counterparties and professional clients, each as defined in MiFID II; and (ii) all channels for distribution of the new shares to retail investors, eligible counterparties and professional clients are appropriate. Any person subsequently offering, selling or recommending the new shares (a “distributor”) should take into consideration the manufacturers’ target market assessment; however, a distributor subject to MiFID II is responsible for undertaking its own target market assessment in respect of the new shares (by either adopting or refining the manufacturers’ target market assessment) and determining appropriate distribution channels. For the avoidance of doubt, even if the target market includes retail investors, the manufacturers have decided that the new shares will be offered, as part of the ATM Program, only to eligible counterparties and professional clients.

^[1] Regulation (EU) 2024/2809 of the European Parliament and of the Council of 23 October 2024 amending Regulations (EU) 2017/1129, (EU) No 596/2014 and (EU) No 600/2014 to make public capital markets in the Union more attractive for companies and to facilitate access to capital for small and medium-sized enterprises

^[2] Regulation (EU) 2024/2809 of the European Parliament and of the Council of 23 October 2024 amending Regulations (EU) 2017/1129, (EU) No 596/2014 and (EU) No 600/2014 to make public capital markets in the Union more attractive for companies and to facilitate access to capital for small and medium-sized enterprises

M1 Kliniken AG increases operating profit (EBIT) by 71% in the first nine months of 2024 and confirms medium-term targets

• Group: sales +8.7% to EUR 257.22 million and EBIT +70.7% to EUR 22.09 million
• Beauty segment growth driver with sales +33.5% to EUR 71.02 million
• EBIT in the Beauty segment +30.4% to EUR 16.26 million
• Medium-term target confirmed: World’s leading private provider of beauty treatments                           

 Berlin, 19.11.2024 –M1 Kliniken AG (ISIN: DE000A0STSQ8) can look back on a strong performance in the first nine months of 2024. Europe’s leading private provider of beauty treatments with the ‘M1 Med Beauty’ brand has significantly increased sales and profits. From January to September 2024, the M1 Group increased consolidated sales by 8.7% from EUR 236.6 million to EUR 257.2 million. Earnings before interest and taxes (EBIT) improved at a much faster rate, rising by 70.7% from EUR 12.94 million to EUR 22.09 million. The Group EBIT margin rose from 5.5% in the same period of the previous year to 8.6%. Net profit (after minority interests) climbed by 247% to EUR 14.33 million in the first nine months of 2024 (9M 2023: EUR 4.13 million). Earnings per share increased accordingly from EUR 0.22 to EUR 0.77 in the reporting period.

The core business of beauty continues to be the growth driver. With the ‘M1 Med Beauty’ brand, the Group is the leading private provider of beauty treatments in Europe and is expanding worldwide. The M1 Group currently operates 63 specialist medical centres for aesthetic medicine in ten countries. At the same time, the M1 Group is significantly increasing sales and profits in the segment. In the first nine months of 2024, the Beauty segment generated revenue of EUR 71.0 million, 33.5% more than in the same period of the previous year (9M 2023: EUR 53.2 million). The operating result (EBIT) climbed by over 30% from EUR 12.5 million to EUR 16.3 million. At 23%, the EBIT margin in the core segment is solidly above the long-term target of 20%.

In the Trading segment, the consistent focus on profitability is showing noticeable success. Segment EBIT rose from EUR 0.4 million to EUR 5.8 million in the reporting period. Sales increased from EUR 183.4 million to EUR 186.2 million. 

Outlook: The world’s leading private provider of beauty treatments

M1 CEO Attila Strauss states: ‘We are continuing our dynamic growth course – both in terms of sales and profits as well as global expansion. It is not just the opening of new locations that is driving our strong operational development. We are also continuously realising untapped potential at our existing locations.’

Overall, the M1 Group believes it is well on track to achieve its medium-term targets: by the end of 2029, the number of medical centres specialising in aesthetic medicine is to increase to between 150 and 200, generating annual revenue of between EUR 200 and 300 million with an EBIT margin of at least 20%. At the same time, M1 intends to establish a shareholder-friendly dividend policy in the coming years.

In addition to further independent development, M1 is continuing to examine strategic options. Several well-known private equity companies have made indicative offers for the Beauty segment regarding an investment or a complete takeover. The process is ongoing and talks with interested parties continued in the third quarter with an open outcome. Strategic options for the future of the Retail segment are also being examined and specific talks are being held with interested parties.

About M1 Kliniken AG

M1 Kliniken AG is the leading fully integrated provider of aesthetic medical healthcare services in Europe. The Group offers products and services of the highest quality standards in the aesthetic and surgical fields. Beauty treatments are currently offered at 63 specialist centres under the ‘M1 Med Beauty’ brand.
With four operating theatres and 35 beds, the M1 Schlossklinik for Plastic and Aesthetic Surgery in Berlin is one of the largest and most modern facilities of its kind in Europe. M1 has been driving forward its internationalisation since the end of 2018 and is currently represented in ten countries.

Contact:
M1 Kliniken AG
Grünauer Straße 5
12557 Berlin
T: +49 (0)30 347 47 44 14
M: ir@m1-kliniken.de

Press Release // November 19, 2024

Formycon invites to earnings call on the nine-month results 2024 and announces participation in international investor conferences

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, „Formycon“) invites to the conference call and webcast for the publication of the nine-month results 2024 on November 28, 2024. The Management Board will discuss the company’s development and the key financial figures as well as the recent uplisting to the Prime Standard of the Frankfurt Stock Exchange. The earnings call, which will be broadcast live on the Internet, will be held in English on November 28, 2024 at 3:00 p.m. (CET). Details and dial-in data see below.

Formycon in Dialogue

Additionally, representatives of the Management Board will participate in the following international investor conferences in the coming weeks:

November 19 – 21, 2024
Jefferies London Healthcare Conference
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO)
London, UK

November 25 – 27, 2024
Deutsches Eigenkapitalforum
Enno Spillner (CFO)
Frankfurt, Germany

December 02, 2024
H.C. Wainwright virtual Fireside chat
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO)
virtual

December 12, 2024
MWB Research Roundtable
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO), Nicola Mikulcik (CBO), Dr. Andreas Seidl (CSO)
virtual

January 13 – 16, 2025
43^rd Annual J.P. Morgan Healthcare Conference
Dr. Stefan Glombitza (CEO), Enno Spillner (CFO), Nikola Mikulcik (CBO)
San Francisco, USA

January 21, 2025
UniCredit & Kepler Cheuvreux German Corporate Conference
Enno Spillner (CFO)
Frankfurt, Germany

For the latest schedule of Formycon’s events, please visit:
https://www.formycon.com/en/investor-relations/financial-calendar/

—

To participate in the conference call, please register at: https://webcast.meetyoo.de/reg/TkZPrWBERFjh

After registration, participants will receive a confirmation email with individual dial-in data.

The presentation and audio broadcast can be accessed via the following webcast link:
https://www.webcast-eqs.com/login/formycon-2024-q3

After a brief presentation, the Management Board will be available for analysts’ questions. The conference call will be recorded and can subsequently be accessed via the Formycon website at:
https://www.formycon.com/en/investor-relations/publications/

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another three biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich and is listed at the Prime Standard of Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110

Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

The Management Board of aap Implantate AG (“Company“) informs today about the increase of the guidance of the EBITDA target. The Company increases its EBITDA in the first nine months from EUR – 1.6 million to EUR 0.  Despite the ongoing investments in silver technology, which amounts to around EUR 0.6 million net after deduction of the funding support, the Company expects a positive EBITDA in the same amount in the operating trauma business and is thus raising the overall guidance for the Company’s EBITDA from EUR -1.5 million to EUR -2.5 million to between EUR -0.5 million and EUR 0.5 million. This means that the company will be able to close a financial year profitably at EBITDA level for the first time in the trauma business. In terms of sales, the company confirms its sales guidance of between EUR 11.5 million and EUR 13.0 million.

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aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German Stock Exchanges –

About aap Implantate AG

aap Implantate AG is a global medical technology company headquartered in Berlin, Germany. The company develops, manufactures and markets products for traumatology. In addition to the innovative anatomical plate system LOQTEQ®, the IP-protected portfolio includes a wide range of perforated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects, such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical and not yet adequately solved problems in traumatology.  In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and affiliated clinics, while on an international level, it primarily uses a broad network of distributors in around 25 countries. In the USA, the company is relying  on a hybrid sales strategy with its subsidiary aap Implants Inc. Sales are carried out both through distribution agents and within the framework of partnerships with global orthopaedic companies. The shares of aap Implantate AG are listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit our website at www.aap.de.

There may be technical rounding differences in the figures presented in this press release, which do not affect the overall statement.

Forward-Looking Statements

This release may contain forward-looking statements based on the current expectations, assumptions and forecasts of the Management Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of future developments and results referred to therein. Various known and unknown risks, uncertainties and other factors could cause the actual results, financial condition, development or performance of the Company to differ materially from the estimates given herein. These factors also include those  described by aap in published reports. Forward-looking statements therefore speak only as of the date on which they are made. We undertake no obligation to update the forward-looking statements made in this release or to conform them to future events or developments.

If you have any questions, please contact: aap Implantate AG; Rubino Di Girolamo; Chairman of the Board of Directors/CEO; Lorenzweg 5; 12099 Berlin

Phone: +49 (0)30 75019 – 141; Fax: +49 (0)30 75019 – 290; Email: r.digirolamo@aap.de

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Press Release // November 18, 2024
 

Formycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama®

• Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends approval of FYB203 for the treatment of Neovascular Age-Related Macular Degeneration (nAMD), along with several other serious retinal diseases
• Approval decision by the European Commission expected in the second half of January 2025

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard) and its licensing partner Klinge Biopharma GmbH (Klinge) jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB203, a biosimilar candidate to Eylea^®1 (aflibercept).

Dr. Stefan Glombitza, CEO of Formycon AG, commented: „We are excited about the positive CHMP opinion for FYB203, our biosimilar candidate to Eylea^®. As our second ophthalmic biosimilar therapy following the success of our Lucentis^®2 biosimilar, FYB203 represents a further advancement in treatment options for serios retinal diseases. After FDA approval in June, this milestone is a testament to the expertise, dedication and hard work of the entire Formycon team and underscores our commitment to enhancing patient care through affordable alternatives. We are now awaiting European Commission approval in the second half of January 2025 and look forward to offering patients a high-quality treatment option that can improve their quality of life.”

Under the tradenames AHZANTIVE^®3/ Baiama^®4 FYB203 has been recommended by the CHMP for approval in Europe for treating adult patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO).

Within the approval process, the CHMP’s positive opinion represents an important regulatory step towards the approval of FYB203/ AHZANTIVE^®/ Baiama^® in the European Union. The CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway, which is expected in the second half of January 2025.

Aflibercept 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 billion⁵, confirming its status as the currently best-selling drug in the field of anti-VEGF therapies.

FYB203 was approved by the U.S. Food and Drug Administration (FDA) in June 2024.
 

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

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another three biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich and is listed at the Prime Standard of Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014
 

Aflibercept-Biosimilar FYB203 / AHZANTIVE^®/ Baiama^® receives positive CHMP Opinion from EMA
 

Planegg-Martinsried, Germany, November 15, 2024 – Formycon (FSE: FYB, “Formycon“) announces that the European Medicines Agency (EMA) published today that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for market approval for FYB203/ AHZANTIVE^®1/ Baiama^®2, a biosimilar candidate to Eylea^®3 (Aflibercept).

FYB203 has thus been recommended for approval in the European Union (EU) for the treatment of adult patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Oedema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Oedema following Retinal Vein Occlusion (RVO). The CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization, which is expected in the second half of January 2025.

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

1) AHZANTIVE^® is a registered Trademark of Klinge Biopharma GmbH
2) Baiama^® is a registered Trademark of Klinge Biopharma GmbH
3) Eylea^® is a registered Trademark of Regeneron Pharmaceuticals Inc.
 

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

phone +49 (0) 89 – 86 46 67 149
fax + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com
www.formycon.com

Disclaimer
Certain statements contained in this release may constitute “forward-looking statements” that involve a number of risks and uncertainties. Forward-looking statements can generally be identified by the use of the words “may,” “will,” “should,” “plan,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “project,” or “aim,” or the negative of these words or other variations of these words or comparable terminology. Forward-looking statements are based on assumptions, forecasts, estimates, projections, opinions or plans that, by their nature, are subject to significant risks and uncertainties and contingencies that are subject to change. Formycon does not and will not give any assurance that any forward-looking statement will be achieved or prove to be accurate. Actual future business, financial condition, results of operations and prospects may differ materially from those projected or anticipated in the forward-looking statements. Subject to applicable legal requirements, neither Formycon nor any other person intends to update, review, revise or revise any forward-looking statements in this release to reflect actual events or developments, whether as a result of new information becoming available, new developments occurring in the future or otherwise, nor does it undertake any such obligation.

PRESS RELEASE

Minister of Economic Affairs Mansoori and Lord Mayor Benz visit Biotest’s plasma center in Darmstadt and call for plasma donations

• Plasma donation centers in Europe to secure the long-term supply of plasma

Dreieich, Germany, November 15, 2024. Darmstadt’s most modern blood plasma donation center in the TOWN HOUSE in the former Roemer department store at the White Tower (Weisser Turm) had prominent visitors. On November 14, numerous guests from politics and business took the opportunity to visit the state-of-the-art plasma donation center at Ernst-Ludwig-Strasse 12. Among the guests were Kaweh Mansoori, Hessian Minister of Economics and Deputy Prime Minister, Hanno Benz, Lord Mayor of Darmstadt, and Peter Franz and Bijan Kaffenberger, Members of the State Parliament. The center is operated by Plasma Service Europe GmbH, a wholly-owned subsidiary of Biotest AG, which was founded more than 20 years ago to strengthen plasma donation in Germany.

Hesse’s Minister of Economics, Kaweh Mansoori, emphasizes: “The Darmstadt Plasma Center opposite the White Tower, is not only an important step in providing patients with life-saving medications. It also creates qualified jobs and revitalizes the city center in a prominent location. Both the people from the region who respond to the call to donate plasma and the employees make an important contribution to the care of seriously ill patients”.

Lord Mayor Hanno Benz sees the new plasma center as an opportunity to raise public awareness of blood plasma donation. “Blood donation is well known, plasma donation less so. However, plasma is also a vital component of medical treatment, especially in the care of people with serious illnesses. It is important to emphasize the importance of plasma donation in our society and to encourage more people to donate regularly. Every donation can save a life, and together we can significantly improve patient care”.

In addition to Peter Janssen, CEO of Biotest AG, and the management of Plasma Service Europe GmbH, a number of interesting guests were also present. Among them was Dr Gerd Klock, patient representative of dsai e.V., a patient organization for congenital immunodeficiencies. He shared his moving life story and spoke to the interested guests about the vital importance of plasma donation for him.

Plasma Service Europe GmbH has an important supply mission: plasma serves as the basis for various, often vital medications. Many rare diseases are treated with medicines made from blood plasma. Since blood plasma cannot be produced artificially, plasma donations are vital for many people.

Peter Janssen, CEO of Biotest AG, welcomed the attendees and highlighted the advantages of the centrally located site: “The state-of-the-art equipment of the Plasma Service center ensures a pleasant atmosphere in which donors feel comfortable. The motivated and highly qualified team enables convenient and smooth donations under professional medical supervision, five days a week, from Monday to Friday. We also hope to welcome many employees of Biotest AG here in Darmstadt.”

The collected plasma is processed exclusively in Germany at Biotest AG in Dreieich. Regular audits in Germany ensure that the high legal and internal quality and safety requirements are met.

About human blood plasma

Human blood plasma is the source material for the production of plasma protein preparations used in the treatment of various diseases of the immune system and the blood system as well as in emergency medicine. Biotest is one of the six largest manufacturers of plasma protein products in the world.

About Plasma Service Europe

Plasma Service Europe GmbH is a wholly owned-subsidiary of Biotest AG, which was founded in 2001 and today operates 14 of the most modern plasmapheresis centers in Germany. Its core competence lies in the collection of blood plasma. To date, more than 170,000 donors have been welcomed. The goal for the future is to be able to supply even more patients with vital medicines.

About Biotest

Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German Stock Exchange. Since May 2022, Biotest has been a part of the Grifols Group, headquartered in Barcelona, Spain (www.grifols.com).

IR contact

Dr Monika Baumann (Buttkereit)
Phone: +49-6103-801-4406
Mail: ir@biotest.com

PR contact

Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
Preference shares: securities’ ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

Ad hoc: Comment on media report

Hamburg, Germany – Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, Prime Standard, ISIN: DE 000 566480 9, WKN 566480; NASDAQ: EVO)

With respect to a media report, Evotec SE (“Company”) declares that it has received, without prior contact, a non-binding expression of interest from the listed US biotechnology company Halozyme Therapeutics Inc. regarding a takeover offer addressed to the shareholders of the Company with an offer price of EUR 11.00 per share. The Company will carefully analyze this expression of interest, decide on next steps, and inform the capital market in accordance with the legal requirements.

– End of the ad hoc release –

Contact: Volker Braun, EVP Head of Global Investor Relations & ESG, Evotec SE, Manfred Eigen Campus, Essener Bogen 7, 22419 Hamburg, Germany, Phone: +49 (0) 151 1940 5058 (m), volker.braun@evotec.com