Formycon publishes nine-month results and confirms guidance – Pipeline progress and strong partnerships drive fiscal year 2025

Formycon AG

/ Key word(s): 9 Month figures/Quarterly / Interim Statement

Formycon publishes nine-month results and confirms guidance – Pipeline progress and strong partnerships drive fiscal year 2025

13.11.2025 / 06:30 CET/CEST

The issuer is solely responsible for the content of this announcement.


Press Release // November 13, 2025
 

Formycon publishes nine-month results and confirms guidance – Pipeline progress and strong partnerships drive fiscal year 2025

  • Guidance for 2025 confirmed – Revenue and earnings development in line with expectations
  • FYB202 (Stelara®1 biosimilar): Market penetration in the US and Europe continues
  • Significant pipeline progress: FYB201 – Launch of the first pre-filled syringe for a ranibizumab biosimilar in Europe; settlement for FYB203 enables US launch; patient recruitment for FYB206 pharmacokinetic (PK) study successfully completed
  • New regulatory guidelines in the US accelerate biosimilar approvals and confirm Formycon’s development strategy
  • International partnerships in Europe, Australia, and Latin America expand market presence
  • Invitation to today’s conference call at 3:00 p.m. (CET)

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today reports on the Group’s business development and financial results for the first nine months of fiscal year 2025. During the reporting period, the company successfully expanded its operational activities and consistently pursued its strategic priorities in the areas of development, financing, partnerships, and competitiveness. Based on these positive developments, Formycon confirms its existing guidance for the 2025 fiscal year.

Enno Spillner, CFO of Formycon, commented: “Operational development and financial performance in the third quarter were in line with expectations. In addition, we confidently anticipate a dynamic fourth quarter and expect significant sales momentum from the ongoing market penetration of our Stelara® biosimilar FYB202 in the US and Europe. In particular, the exclusive US distribution agreement concluded by Fresenius Kabi with CivicaScript promises a significant increase in sales in the fourth quarter. In addition, we expect further positive momentum from the advanced commercialization discussions for our Keytruda®2 biosimilar candidate FYB206 in selected regions. Our rigorous, streamlined development program without a Phase III study has enabled us to advance the clinical development of FYB206 significantly faster and more cost-efficiently. The successful completion of patient recruitment once again underscores our pioneering role in global biosimilar development and at the same time strengthens our appeal for future partnerships. With strict cost control and the solid financing structure from our first corporate bond in the summer, we are well positioned to achieve our annual targets.”

Group revenues and earnings development on track – guidance for 2025 confirmed

In the first nine months of 2025, the Formycon Group generated revenues of approximately €19.5 million (9M/2024: €41.1 million). While the previous years’ figures included one-time payments from license and milestone agreements for FYB202, current revenues increasingly derive from recurring proceeds from the marketing of approved biosimilars, from development services for out-licensed or jointly developed projects, and from service payments for supply chain coordination.

Revenues from the ranibizumab biosimilar FYB201 from direct participation in commercialization proceeds amounted to €1.5 million (9M/2024: €6.0 million). As previously reported, Sandoz temporarily paused commercialization in the US from the second quarter of 2025 for tactical market reasons; based on current information, resumption is planned for the first quarter of 2026. In the remaining 24 markets outside the US – including Europe and the MENA region – FYB201 continued to be marketed, and development proceeded as expected. After the end of the reporting period, FYB201 was launched as the first ready-to-use syringe of a ranibizumab biosimilar in the first European countries. The syringe system sets new standards in quality and innovation and increases the marketing potential of the ranibizumab biosimilar FYB201 in Europe.

The Stelara® biosimilar FYB202 (Otulfi®3/Fymskina®4) developed according to plan during the reporting period. Following the market launch by our partner Fresenius Kabi in March, market development is progressing steadily. In the US, FYB202 is primarily distributed through the pharmacy benefit channel. An exclusive distribution agreement with CivicaScript and other contracts have now been concluded. In Europe, FYB202 has already been launched in 18 countries. In Germany, our distribution partner Ratiopharm has additionally been handling sales for FYB202/Fymskina® since this summer. Revenues from direct participation in the commercialization of FYB202 amounted to €3.2 million (9M/2024: €0). Milestone payments of €0.5 million were also realized for approvals in additional regions. Based on the contracts concluded and the expected order volumes, Formycon anticipates a significant increase in revenue contributions from FYB202 in the final quarter of 2025.

The Group’s earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to
€-21.4 million in the reporting period (9M/2024: €-17.7 million) and were thus in line with planning. This development mainly reflects the temporary decline in sales revenues resulting from the transition phase between one-time license payments and the increasing share of sales from commercialized products. Adjusted EBITDA amounted to €-21.7 million (9M/2024: €2.9 million) and includes the earnings contribution from the 50% stake in Bioeq AG.

The at-equity result of Bioeq AG for the first nine months was €-0.3 million (9M/2024: €20.6 million), reflecting the temporary marketing pause for FYB201 in the US. The forecast for EBITDA and adjusted EBITDA in the range of €-20 million to €-10 million for the full year remains unchanged.

The current positive developments in easing regulatory requirements, such as the waiver of Phase III clinical trials as a standard requirement, are paving the way for shorter and less expensive development cycles and allowing Formycon to focus its structures on greater efficiency. Based on the successful development and approval of three biosimilar products, the company is leveraging the experience it has gained to pool capacities in a targeted manner, further optimize the use of resources, and significantly reduce costs. The growing use of digital technologies and artificial intelligence is increasingly helping to make development processes focused, lean, and thus competitive. Formycon is aiming for EBITDA-profitable corporate development in the medium term and expects that a positive EBITDA result can ideally be achieved in 2026, but no later than in the 2027 fiscal year.

In the second quarter of 2025, Formycon AG successfully placed its first corporate bond 2025/2029 (ISIN NO0013586024 / WKN A4DFJH) in Nordic Bond format with a total volume of €70 million on the capital market. The four-year, floating-rate bond (maturity: July 2029) bears interest based on the 3-month Euribor plus a margin of 7.00% p.a.; interest payments are made quarterly. Investor feedback during the roadshow and after the placement confirms confidence in Formycon’s promising growth strategy and business model.

In connection with the successful placement of a €70 million corporate bond, the working capital forecast was already raised in the first half of the year. Working capital amounted to €83.2 million in the first nine months (9M/2024: €65.8 million), securing the financing of ongoing development activities and operating business in the medium and long term.

Operational development on track – strategic progress and settlement and license agreement confirm outlook for the full year

Dr. Stefan Glombitza, CEO of Formycon AG, said: “In fiscal year 2025, we further refined our strategy in the areas of development, partnerships, and competitiveness and achieved important milestones. With the introduction of the innovative FYB201 prefilled syringe, we are setting new standards in ophthalmic care and creating additional differentiation in the European market. The settlement of the patent dispute with Regeneron regarding FYB203 also marks a decisive step forward in the US market entry of our Eylea®5 biosimilar and strengthens our position in one of the largest biosimilar markets worldwide. The latest initiative by the US health authority to simplify the approval process for biosimilars marks a significant regulatory advance with immediate relevance for our industry. The planned facilitations can significantly shorten development times and at the same time make them more cost-effective. We anticipated this change early on and aligned our clinical strategy for our Keytruda® biosimilar candidate FYB206 accordingly in consultation with the FDA. The streamlined design of our clinical program already shows that scientific excellence can be successfully combined with economic efficiency. These developments confirm our approach and create additional opportunities to develop and bring biosimilars to market faster, more cost-effectively, and with high quality.”

In the third quarter of 2025, Formycon advanced the development of key biosimilar projects as planned and achieved significant operational progress. This includes, in particular, further progress with the pembrolizumab biosimilar candidate FYB206. Following positive regulatory feedback, a Phase III study was not required as therapeutic comparability can be demonstrated by comprehensive analytical data and the ongoing Phase I Pharmacokinetic (PK) study. Patient recruitment for this ongoing Phase I PK study was already completed in July. Formycon expects results for the primary endpoint in the first quarter of 2026.

Further important steps toward market expansion and portfolio differentiation were taken after the end of the reporting period: One focus was on the launch of the pre-filled syringe version of the ranibizumab biosimilar FYB201 (Ranivisio®6) in Europe by our partner Teva. At the beginning of October, a settlement and license agreement for FYB203 was concluded with Regeneron, which resolves all the patent disputes in connection with the aflibercept biosimilar FYB203/Ahzantive®7 in the US. From today’s perspective, this means that the biosimilar, which has already been approved by the FDA, could enter the market in the fourth quarter of 2026. Exclusive commercialization in the United States and Canada will be carried out by the distribution partner Valorum Biologics based on the license agreement concluded at the end of June 2025.

In addition, exclusive commercialization agreements for FYB203 were signed with Actor Pharmaceuticals for Australia and with Megalabs for Latin America. A co-marketing partnership was agreed with Horus Pharma for selected European countries. These partnerships will expand FYB203’s future geographic market coverage and penetration and strengthen Formycon’s competitive position. At the same time, development activities for early-stage projects continued as planned.

Key financial performance indicators at a glance

in € million Results 9M 2024 Results 9M 2025 Guidance 2025
Revenue 41.1 19.5 55.0 to 65.0
EBITDA -17.7 -21.4 -20.0 to -10.0
Adjusted EBITDA 2.9 -21.7 -20.0 to -10.0
Working Capital 65.8 83.2 55.0 to 65.0

Balance sheet IFRS

in € million September 30, 2025 December 31, 2024
Assets 789.1 771.7
Non-current assets 676.1 676.7
Other intangible assets 457.2 444.1
Right-of-use (ROU) assets 10.2 10.7
Property, plant and equipment 3.5 3.8
Investment accounted for using the equity method 151.6 151.9
Financial assets 53.7 66.1
Current assets 113.0 95.0
Inventories 0.5 0.3
Trade and other receivables 10.1 23.7
Contract assets 6.3 7.0
Other financial assets 0.7 0.01
Prepayments and other assets 15.8 22.1
Income tax receivables 0.1 0.09
Cash and cash equivalents 79.5 41.8
Equity and liabilities 789.1 771.7
Equity 402.7 461.8
Subscribed capital 17.7 17.7
Capital reserve 497.3 496.0
Balance sheet profit -112.2 -51.8
Non-current liabilities 356.9 276.0
Non-current lease obligations 8.4 9.1
Non-current financial liabilities 247.0 164.2
Other non-current liabilities 0.3 0.5
Deferred tax liabilities 101.2 102.2
Current liabilities 29.4 33.9
Current lease obligations 1.5 1.5
Current financial liabilities 7.2 8.7
Other current liabilities 6.0 4.3
Trade payables 12.7 17.4
Current income tax liabilities 2.0 2.0

 

Condensed statement of comprehensive income

in € million Result 9M 2025 Result 9M 2024
Revenue 19.5 41.1
Cost of sales 37.2 32.5
Research and development expenses 9.5 13.4
Selling expenses 1.0 0.8
Administrative expenses 13.0 13.4
Other expenses and income 0.4 0.3
Operating profit (loss) / EBIT -41.6 -19.3
Net finance income -19.7 2.0
Profit before tax -61.3 -17.3
Income tax expense 0.9 – 3.6
Profit (loss) / Comprehensive income (loss) for the period -60.4 -20.9

 

Condensed cash flow statement

in € million Result 9M 2025 Result 9M 2024
Cash flow from operating activities -3.7 -41.0
Profit (loss) for the period -60.4 -20.9
Depreciation and amortization 20.2 1.7
Net finance result 19.7 -2.0
Other non-cash expenses / income 0.0 5.2
Changes in working capital 16.8 -24.9
Net cash used for investing activities -19.3 -2.9
Outflow for investments in long-term assets -32.1 -26.2
Proceeds from loans issued 12.8 23.3
Net cash from financing activities 60.7 50.6
Proceeds from issuance of shares 0.1 83.0
Proceeds from financial liabilities 68.6
Outflows for financial liabilities and interest paid -8.0 -32.4
Cash-effective change in cash and cash equivalents 37.7 6.8
Cash and cash equivalents at the end of the period 79.5 33.8
Cash and cash equivalents at the beginning of the period 41.8 27.0

 

Conference call and dial-in details

The Executive Board will discuss the company’s performance and key financial figures and provide an outlook for the remainder of fiscal year 2025. The conference call, which will be broadcast live on the Internet, will take place on Thursday, November 13, 2025, at 3:00 p.m. (CET) in English.

To participate in the conference call, please register at:

https://webcast.meetyoo.de/reg/KYTa1G3ju56X

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

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

https://www.webcast-eqs.com/formycon-2025-q3

Following a brief presentation, the Executive Board will be available to answer questions from analysts. The conference call will be recorded and subsequently available on the Formycon website at: https://www.formycon.com/en/investors/publications/.

  1. Stelara® is a registered trademark of Johnson & Johnson
  2. Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
  3. Otulfi® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
  4. Fymskina® is a registered trademark of Formycon AG
  5. Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
  6. Ranivisio® is a registered trademark of Bioeq AG
  7. AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH

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 and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline 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, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. 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.


13.11.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
View original content: EQS News


Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Germany
Phone: 089 864667 100
Fax: 089 864667 110
Internet: www.formycon.com
ISIN: DE000A1EWVY8, NO0013586024
WKN: A1EWVY, A4DFJH
Indices: SDAX,
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange; Oslo
EQS News ID: 2228876

 
End of News EQS News Service

2228876  13.11.2025 CET/CEST

Evotec receives milestone payment from Bristol Myers Squibb following IND acceptance in strategic protein degradation partnership

Evotec SE

/ Key word(s): Miscellaneous

Evotec receives milestone payment from Bristol Myers Squibb following IND acceptance in strategic protein degradation partnership

12.11.2025 / 07:30 CET/CEST

The issuer is solely responsible for the content of this announcement.


  • Milestone payment reflects continued progress under strategic research collaboration addressing high-need patient populations
  • FDA clearance of IND application triggered a US$ 5 m milestone payment to Evotec
 

Hamburg, Germany, 12 November 2025:
Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, Prime Standard, ISIN: DE0005664809, WKN 566480; NASDAQ: EVO) today announced that it has received a US$ 5 m milestone payment from Bristol Myers Squibb, following the acceptance of an Investigational New Drug (“IND”) application by the U.S. Food and Drug Administration (“FDA”) in their strategic protein degradation partnership. The drug candidate, a cereblon E3 ligase modulator (“CELMoD™”) was developed under the collaboration, and a Phase 1 clinical trial is expected to begin in 2026.

Initiated in 2018, the collaboration combines Evotec’s high-performance multi-omics screening as well as AI-supported data analytics and drug design capabilities with Bristol Myers Squibb’s industry-leading library of CELMoDs™. The collaboration, expanded in 2022, continues to deliver on its goal to identify novel molecular glue degraders for high-value targets in the field of oncology and beyond.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are excited to have reached this important achievement in our collaboration with Bristol Myers Squibb, and to move one step closer to bringing the first compound of our molecular glue degrader pipeline to the clinic. This IND acceptance represents not only a major scientific and regulatory milestone but also validates the strength of our collaboration and emphasizes the enormous potential for delivering multiple first-in-class products to market.“

About molecular glue degraders
Conventional small molecule therapeutics work via a drug-induced interference with a protein activity. This limitation to agonistic or antagonistic functions renders about 90% of proteins “undruggable”. Also, conventional small molecules only work while they are actively binding to the receptor, which typically requires a treatment regimen consisting of one or even several carefully dosed medications every day.

Molecular glue degraders are compounds that induce interactions between an E3 ubiquitin ligase and a molecular target. The induced interaction results in ubiquitination and subsequent degradation of the recruited protein. Through this mechanism of action molecular glues are not restricted to the agonistic/antagonistic features of a protein, thus massively expanding the range of the druggable proteome. Also, the molecular glue itself is not degraded in the process and can trigger the degradation process several times over, thus leading to longer-lasting therapeutic effects.

About Evotec’s strategic collaboration with Bristol Myers Squibb in molecular glues
In 2018, Evotec entered a long-term strategic drug discovery and development collaboration in the field of molecular glues with Celgene, now Bristol Myers Squibb. Bristol Myers Squibb is a leader in this field based on its unique library of CELMoDs™. The collaboration aims to discover and develop a leading pipeline of molecular glue degraders for a range of therapeutic indications leveraging all of Evotec’s proprietary PanOmics and PanHunter platforms as well as AI/ML-based drug discovery and development capabilities.

Evotec applies high-end proteomics and transcriptomics at industrial scale to profile and select promising drug candidates based on comprehensive cell biological profiles. Evotec’s leading PanOmics screening capabilities are delivering unmatched throughput. The selection of the most promising candidates for drug development is facilitated by Evotec’s PanOmics data analysis platform PanHunter. PanHunter supports the integration and analysis of these data sets and thereby enables the selection of the most promising CELMoDs™ for further progression into lead optimization.

 

About Evotec SE
Evotec is a life science company that is pioneering the future of drug discovery and development. By integrating breakthrough science with AI-driven innovation and advanced technologies, we accelerate the journey from concept to cure — faster, smarter, and with greater precision.

Our expertise spans small molecules, biologics, cell therapies and associated modalities, supported by proprietary platforms such as Molecular Patient Databases, PanOmics and iPSC-based disease modeling.

With flexible partnering models tailored to our customers’ needs, we work with all Top 20 Pharma companies, over 800 biotechs, academic institutions, and healthcare stakeholders. Our offerings range from standalone services to fully integrated R&D programs and long-term strategic partnerships, combining scientific excellence with operational agility.

Through Just – Evotec Biologics, we redefine biologics development and manufacturing to improve accessibility and affordability.

With a strong portfolio of over 100 proprietary R&D assets, most of them being co-owned, we focus on key therapeutic areas including oncology, cardiovascular and metabolic diseases, neurology, and immunology.

Evotec’s global team of more than 4,800 experts operates from sites in Europe and the U.S., offering complementary technologies and services as synergistic centers of excellence. Learn more at www.evotec.com and follow us on LinkedIn and X/Twitter @Evotec.

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

 

For further information, please contact:

Media
Susanne Kreuter 
VP Head of Strategic Marketing 

Susanne.Kreuter@evotec.com 

Investor Relations
Volker Braun
EVP Head of Global Investor Relations & ESG
Volker.Braun@evotec.com


12.11.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
View original content: EQS News


Language: English
Company: Evotec SE
Manfred Eigen Campus / Essener Bogen 7
22419 Hamburg
Germany
Phone: +49 (0)40 560 81-0
Fax: +49 (0)40 560 81-222
E-mail: info@evotec.com
Internet: www.evotec.com
ISIN: DE0005664809
WKN: 566480
Indices: SDAX, TecDAX
Listed: Regulated Market in Berlin, Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange; Nasdaq
EQS News ID: 2227682

 
End of News EQS News Service

2227682  12.11.2025 CET/CEST

Sandoz signs global license agreement to commercialize breast cancer biosimilar pertuzumab

  • Agreement with EirGenix Inc. grants Sandoz exclusive rights to commercialize proposed biosimilar of pertuzumab for treatment of HER2-positive early breast cancer / metastatic breast cancer
  • Reference medicine market worth USD 4.1 billion in global sales
  • Pertuzumab used in combination with other therapies, highly complementary to proposed Sandoz biosimilars trastuzumab and trastuzumab deruxtecan
  • Strengthens overall Sandoz position in oncology and reinforces ongoing commitment to expand patient access to affordable medicines and drive sustainable savings for healthcare systems 

Basel, November 12, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announced the signing of a global license agreement to commercialize a proposed biosimilar of oncology medicine pertuzumab.

The agreement with EirGenix Inc. (EirGenix Inc., 6589.TW) is milestone-based for a total consideration of up to USD 152 million, including an upfront payment and further potential incentives dependent upon market performance. The reference medicine market is worth an estimated USD 4.1 billion1 in global sales, and pertuzumab will join the deep Sandoz pipeline with the strategic objective to capitalize on a projected ~USD 300 billion biosimilar market opportunity over the next 10 years2.

Under the terms of the agreement, Sandoz has exclusive worldwide commercial rights to a biosimilar of pertuzumab, excluding certain countries in Asia*, while EirGenix Inc. will be responsible for development, manufacturing and supply. The medicine has already completed a human pharmacokinetic similarity clinical study.

Richard Saynor, CEO of Sandoz, said: “According to the latest estimates, up to 2.3 million patients worldwide are diagnosed with breast cancer each year and, of these cases, approximately 15% to 20% are HER2-positive breast cancer3.

“This agreement underscores our commitment to expand patient access, as well as support healthcare systems by offering high quality and more affordable treatment options. It also enhances our biosimilar oncology portfolio and complements our pipeline, given that the combination of pertuzumab and trastuzumab represents the standard of care in this field.”

The reference medicine Perjeta®** is a humanized IgG1 monoclonal antibody that is used in combination with other therapies, including trastuzumab, to treat HER2-positive early breast cancer and HER2-positive metastatic or locally recurrent unresectable breast cancer4,5.

The agreement strengthens the collaboration between Sandoz and EirGenix Inc, with an existing agreement already in place for worldwide commercialization*** of the proposed biosimilar trastuzumab, in both 150 mg and 420 mg forms. Studies also show that a combination of pertuzumab and trastuzumab deruxtecan could become a new first-line standard for HER2-positive metastatic breast cancer6, with a biosimilar of trastuzumab deruxtecan currently in the Sandoz pipeline.

Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably, with a leading global portfolio comprising 11 marketed biosimilars and a further 27 assets in various stages of development. The marketed biosimilar oncology portfolio includes Rixathon®, Zarzio®, Ziextenzo® and Binocrit®. Sandoz also launched Wyost®/Jubbonti® (denosumab) in the US in June 2025 and expects to launch in Europe in the fourth quarter of 2025.

 

* Countries out of scope: Taiwan, China, Macau, Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines and Japan

** Perjeta® is a registered trademark of Roche

*** Under this agreement, Sandoz holds the right to commercialize the medicine globally except in Russia, China, Taiwan, Australia, and some other Asian and South American countries

 

DISCLAIMER

This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.

 

REFERENCES

1 Evaluate Pharma, Summary: Worldwide Sales [Last accessed November 2025]

2 Based on March 2025 data from IPD Analytics Evaluate Pharma, covering the period 2026–2035

3 World Cancer Research Fund, ‘Breast Cancer Statistics’. Available at: Breast cancer statistics | World Cancer Research Fund [Last accessed November 2025]

4 Perjeta® Summary of Product Characteristics. Available at: Perjeta, INN-pertuzumab [Last accessed November 2025]

5 Perjeta® Prescribing Information. Available at: PERJETA [Last accessed November 2025]

6 The trial DESTINY-Breast09 showed that Enhertu® (trastuzumab deruxtecan) and pertuzumab significantly delayed cancer progression compared to the current standard of care (taxane and trastuzumab and pertuzumab)

 

ABOUT SANDOZ

Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.  

 

 

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Global Media Relations contacts

Investor Relations contacts

Global.MediaRelations@sandoz.com

Investor.Relations@sandoz.com

Alexis Kalomparis
+41 792 790285

Craig Marks

+44 7818 942 383

Chris Lewis

+49 174 244 9501

Silvia Siegfried

+41 79 795 9061

Gregor Rodehueser

+49 170 574 3200

 

 

Pentixapharm Publishes 9-Month Figures for 2025

Pentixapharm Holding AG

/ Key word(s): 9 Month figures/Quarterly / Interim Statement

Pentixapharm Publishes 9-Month Figures for 2025

12.11.2025 / 08:00 CET/CEST

The issuer is solely responsible for the content of this announcement.


Pentixapharm Publishes 9-Month Figures for 2025

  • Loss of the reporting period €12,7 million (attributed to research and development activities, personnel and other operating expenses)
  • Revenue of the reported period €117 thousands
  • Balance sheet total as of September 30, 2025: €43 million
  • Adjusted Guidance for the fiscal year 2025: expected loss approximately €18 million (before: €23.5 million).

Berlin, Germany, 12 November 2025

The Executive Board of Pentixapharm Holding AG announced the following today:

Based on the newly published interim financial statements, the Group closed the first nine months of the 2025 fiscal year with a loss of EUR 12.7 million.

Based on current planning, the Company adjusts the guidan cefor the full 2025 fiscal. The Executive Board now expects a loss of approximately €18 million (before €23.5 million) as published on 06 November 2025.

This forecast includes research and development expenses as well as personnel and other operating expenses while potential income from out-licensing is not included in the forecast.

The full interim financial statements is available on the Pentixapharm Holding AG Investor Relations website: www.pentixapharm.com/investors/reports.

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops first-in-class ligand- and antibody-based radiopharmaceuticals designed to transform patient care across oncology and beyond. Its late-stage pipeline is anchored by CXCR4-targeted programs, including a Phase 3-ready diagnostic candidate for primary aldosteronism and pioneering therapeutic programs in a number of hematological and solid cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-escape marker over-expressed in multiple hard-to-treat cancers. Complemented by reliable isotope supply from Eckert & Ziegler, and a robust global clinical network, Pentixapharm is uniquely positioned to deliver innovative radiopharmaceuticals that address high unmet need, improve patient outcomes, and create significant growth opportunities in one of the fastest-growing areas of precision medicine.

Pentixapharm Investor and Media Contact

ir@pentixapharm.com

 


12.11.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
View original content: EQS News


Language: English
Company: Pentixapharm Holding AG
Robert-Rössle-Straße 10
13125 Berlin
Germany
E-mail: info@pentixapharm.com
Internet: https://www.pentixapharm.com/
ISIN: DE000A40AEG0
WKN: A40AEG
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2228042

 
End of News EQS News Service

2228042  12.11.2025 CET/CEST

Straumann Group Capital Markets Day 2025

 

Date: Tuesday, November 25, 2025

Time: 9:00 a.m. – approximately 1:30 p.m. CET

 

 

Straumann Group is pleased to invite you to its Capital Markets Day 2025 on Tuesday, November 25, 2025.

 

We will reflect on the progress made, revisiting our vision and commitments. The session will outline the Group’s key achievements to date and present our mid-term strategy and growth ambitions. We will also address the evolving market landscape and accelerating trends that continue to shape our industry and guide our transformation. Presentations and the Q&A session will be delivered in English by the Executive Management Team

 

You can access the webcast at www.straumann-group.com/webcast. A recording will be available after the event. To participate in the Q&A, please pre-register for the conference call using the dedicated link. We also recommend downloading the presentation in advance via the direct link in the media release on www.straumann-group.com before joining the conference call.

 

For further information, please contact investor.relations@straumann.com.

 

With kind regards

Straumann Group

Corporate Communications & Investor Relations

 

 

Medios AG achieves strong growth in earnings and profit margin in the first nine months of 2025

Medios AG

/ Key word(s): Quarterly / Interim Statement/Quarter Results

Medios AG achieves strong growth in earnings and profit margin in the first nine months of 2025

11.11.2025 / 07:24 CET/CEST

The issuer is solely responsible for the content of this announcement.


Press release

Medios AG achieves strong growth in earnings and profit margin in the first nine months of 2025

  • Revenue increases by 9.2% to €1,530.0 million
  • Disproportionately high EBITDA pre1 increase of 26.1%
  • Organic EBITDA pre1 growth of 5.1%
  • Cash flow from operating activities almost doubles
  • Significant improvement in earnings per share to €0.79
  • New CEO Thomas Meier to take office on February 1, 2026
  • Outlook for 2025 confirmed

Berlin, November 11, 2025 – The Medios-Group (“Medios“ or “the Company”), a leading provider of Specialty Pharma in Europe, once again delivered strong performance in the period from January to September 2025 and confirms its forecast for the full year. Revenue rose by 9.2% to €1,530.0 million in the nine-month period (9M). EBITDA pre1 rose again disproportionately by 26.1% to €70.4 million. Organic EBITDA pre1 growth amounted to 5.1%. As a result, the EBITDA pre1 margin improved by 0.6 percentage points to 4.6%. Consolidated net income after taxes nearly doubled to €19.9 million (9M 2024: €10.4 million). Earnings per share thus rose to €0.79 (9M 2024: €0.43). Cash flow from operating activities also increased significantly to €52.7 million (9M 2024: €27.6 million).

Matthias Gärtner, CEO of Medios AG, stated: “We are very pleased with the current business performance. In the third quarter, we not only achieved a significant increase in revenue to around €538 million, but also our earnings of €24 million were very close to the record figure of €24.6 million in the same quarter of the previous year, which was characterized by a positive one-off effect due to inflation. Over the first nine months, we recorded strong growth and further improved all key figures. This successful development once again reflects the consistent execution of our growth strategy.”

Revenue and earnings growth in all operating segments
The Pharmaceutical Supply business segment achieved a 4.1% increase in revenue to €1,239.5 million in the first nine months of 2025. EBITDA pre1 rose by 4.7% to €38.8 million, mainly as a result of organic earnings growth due to the strategic focus on higher-margin revenue.

The Patient-Specific Therapies business segment recorded a 2.7% increase in revenue to €166.0 million from January to September 2025. The segment’s EBITDA pre1 rose by 8.4% to €18.1 million, reflecting strong organic growth and a further optimized product mix.

The International Business division generated revenue of €124.2 million in the nine-month period 2025 (June to September 2024: €47.3 million). The division contributed €22.0 million to EBITDA pre1 (June to September 2024: €9.8 million).

New CEO to take office on February 1, 2026
The Supervisory Board of Medios AG has appointed Thomas Meier as a member of the Executive Board with effect from February 1, 2026, and named him as the new Chief Executive Officer (CEO) of the company. He succeeds Matthias Gärtner, who will remain in office until December 31, 2025.

Outlook for 2025 confirmed
Medios confirms its forecast for the 2025 financial year. The company expects sales revenue to increase by around 6% to approximately €2 billion. EBITDA pre1 is expected to rise disproportionately by around 21.5% to approximately €96 million. This corresponds to a further increase in the EBITDA pre1 margin to around 4.8%. This expectation is based on the assumption of organic growth in the mid-single-digit percentage range and takes into account the consolidation of the Ceban Group for twelve months.

 

Key figures (IFRS)                        
in € million   9M 2025   9M 2024   ∆ in %   Q3 2025   Q3 2024   ∆ in %
Revenue   1,530.0   1,400.5   9.2   538.3   493.2   9.1
  Pharmaceutical Supply   1,239.5   1,191.2   4.1   439.4   403.3   8.9
  Patient-Specific
  Therapies
  166.0   161.6   2.7   55.8   54.1   3.2
  International Business   124.2   47.3   >100   43.0   35.7   20.6
  Services   0.4   0.5   –21.6   0.1   0.2   –46.8
EBITDA pre1   70.4   55.8   26.1   24.0   24.6   –2.5
  Pharmaceutical Supply   38.8   37.0   4.7   12.4   14.2   –12.5
  Patient-Specific
  Therapies
  18.2   16.7   8.4   6.1   5.9   3.9
  International Business   22.0   9.8   >100   8.2   7.1   15.2
  Services   –8.6   –7.8   10.3   –2.6   –2.5   6.4
Consolidated net income after taxes   19.9   10.4   90.8   7.2   4.0   79.5
Cash flow from operating activities   52.7   27.6   91.1   29.3   –6.5   n/a
Earning per share (in €)   0.79   0.43   84.0   0.29   0.16   84.2

 

The Quarterly Statement of Medios AG as of September 30, 2025 is available for download on the Investor Relations website.

 

Important dates for Medios AG in the 2025 financial year

November 12 mwb inspired Investorenkonferenz – Hamburg
December 04 Berenberg European Conference – Fairmont Windsor Park, UK

1 EBITDA is defined as consolidated earnings before interest, taxes, depreciation and amortization. EBITDA pre is adjusted for special charges for stock options, expenses for M&A activities and, in 2023 and 2024, performance-related payments for the acquisition of compounding volumes. Since 2024, expenses for the implementation of the ERP system have also been included. In addition, one-off special expenses related to the changes in the Executive Board were adjusted in 2025.

——————-

About Medios AG
Medios is a leading provider of Specialty Pharma in Europe. With locations in Germany, the Netherlands, Belgium and Spain, the Company supports key partners in the supply chain with innovative solutions and intelligent services. Medios has focused on pioneering individualized medicine to make the most innovative therapies available to everyone together with pharmacies, specialist practices and pharmaceutical companies.

Medios AG is Germany’s first listed specialty pharmaceutical Company. The shares (ISIN: DE000A1MMCC8) are listed on the regulated market of the Frankfurt Stock Exchange (Prime Standard) and are included in the SDAX selection index.

www.medios.group

 

More information on individualized medicine: https://app.medios.group/en/individualizedmedicine

 

Contact
Claudia Nickolaus
Head of Investor & Public Relations, ESG Communications
Medios AG
Heidestraße 9 | 10557 Berlin
T +49 30 232 566 800
ir@medios.group
www.medios.ag

Disclaimer
This communication contains forward-looking statements that are subject to certain risks and uncertainties. Future results could differ materially from those currently anticipated as a result of various risk factors and uncertainties, including, but not limited to, changes in business, economic and competitive conditions, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings and the availability of financing. Medios AG assumes no responsibility to update any forward-looking statements contained in this release.


11.11.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
View original content: EQS News


Language: English
Company: Medios AG
Heidestraße 9
10557 Berlin
Germany
Phone: +49 30 232 566 – 800
Fax: +49 30 232 566 – 801
E-mail: ir@medios.group
Internet: www.medios.group
ISIN: DE000A1MMCC8
WKN: A1MMCC
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2227234

 
End of News EQS News Service

2227234  11.11.2025 CET/CEST

Pentixapharm to Report Third Quarter and First Nine Months 2025 Financial Results on Wednesday, November 12, 2025

Pentixapharm Holding AG

/ Key word(s): 9 Month figures/Quarterly / Interim Statement

Pentixapharm to Report Third Quarter and First Nine Months 2025 Financial Results on Wednesday, November 12, 2025

10.11.2025 / 08:00 CET/CEST

The issuer is solely responsible for the content of this announcement.


Pentixapharm to Report Third Quarter and First Nine Months 2025 Financial Results
on Wednesday, November 12, 2025
 

Berlin, Germany, November 10, 2025 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, will publish its financial results for the third quarter and first nine months of 2025 on Wednesday, November 12, 2025.

Management will host a conference call and webcast on the same day to discuss the quarterly results and provide a business update.

 

Conference Call and Webcast Details

Date: Wednesday, November 12, 2025

Time: 3 p.m. CET / 9:00 a.m. EST

 

Registration link to participate in the conference call:

https://webcast.meetyoo.de/reg/BXIDSCew5bUU

 

Live webcast link:

https://www.webcast-eqs.com/pentixapharm-202511

 

Presentation slides will be posted shortly before the start of the webcast at the Investor Relations section of the Pentixapharm website. A replay of the webcast will be available at this website shortly after the event.

 

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops first-in-class ligand- and antibody-based radiopharmaceuticals designed to transform patient care across oncology and beyond. Its late-stage pipeline is anchored by CXCR4-targeted programs, including a Phase 3-ready diagnostic candidate for primary aldosteronism and pioneering therapeutic programs in a number of hematological and solid cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-escape marker over-expressed in multiple hard-to-treat cancers. Complemented by reliable isotope supply from Eckert & Ziegler, and a robust global clinical network, Pentixapharm is uniquely positioned to deliver innovative radiopharmaceuticals that address high unmet need, improve patient outcomes, and create significant growth opportunities in one of the fastest-growing areas of precision medicine.

 

Pentixapharm Investor and Media Contact

ir@pentixapharm.com


10.11.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
View original content: EQS News


Language: English
Company: Pentixapharm Holding AG
Robert-Rössle-Straße 10
13125 Berlin
Germany
E-mail: info@pentixapharm.com
Internet: https://www.pentixapharm.com/
ISIN: DE000A40AEG0
WKN: A40AEG
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2226488

 
End of News EQS News Service

2226488  10.11.2025 CET/CEST

BioVersys BV100 Phase 2B to be conducted via Wellcome Funded Trial Network

 

Trial to be conducted by ADVANCE-ID, a national university of singapore led trial network, in partnership with BioVersys

 

Basel, Switzerland, November 10, 2025, 7am CET

 

  • Panel of independent experts selected BioVersys’ BV100 out of 24 candidates to participate in the ADVANCE-ID and National University of Singapore (NUS) Asia clinical trial network of 130 sites across 35 countries
  • Wellcome funds ADVANCE-ID/NUS with SGD 22 million (c. CHF 14 million) to conduct their first Sponsor (BioVersys) driven Phase 2 trial
  • Non-dilutive funding received for the trial strengthens BioVersys’ cash position and extends the company’s cash runway further into 2028
  • This partnership allows the BV100 Phase 2b open-label study to increase patient size to 90 patients with an interim data read-out expected in H2 2026

 

BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multidrug-resistant (MDR) bacteria, announced today that its lead asset BV100, an innovative anti-infective developed for hospital infections caused by Acinetobacter baumannii, including carbapenem resistant strains (CRAB), has been selected to participate in the ADVANCE-ID clinical trial network which has its hub at the Saw Swee Hock School of Public Health, National University of Singapore. BV100 was selected by an independent expert panel out of 24 applications to be awarded this Phase 2b support.

BioVersys had announced its plan to conduct a Phase 2b study in parallel to the upcoming Phase 3 study in order to generate additional clinical data to support the future BV100 new drug application, collect additional clinical evidence in real world settings in countries with very high drug resistance levels and allow the comparison with some of the newest approved drugs.

This Phase 2b will now be conducted by the ADVANCE-ID clinical trial network in several countries in Southeast Asia, in settings with very high levels of drug-resistant infections and in close collaboration with BioVersys. This Phase 2b study has been made possible thanks to the generous contribution of Wellcome who strengthened the ADVANCE-ID network with SGD 22 million (c. USD 17m or CHF 14m), enabling the first sponsor driven clinical trial run by ADVANCE-ID in close collaboration with an industry sponsor, BioVersys. In addition to significantly reducing the financial cost to BioVersys, conducting the Phase 2b in partnership with the ADVANCE-ID clinical trial network increases the number of treatment arms from two to three treatment arms, including two arms for BV100 combined with either Ceftazidime/avibactam or with Cefiderocol, and one arm for Best Available Therapy. Consequently, the total number of evaluable patients increases from 60 patients to 90 patients in Part A, compared to the initial Phase 2b development plan. This Phase 2b will enroll patients with VABP/HABP and BSI suffering from CRAB (Part A), and patients with CRAB ventriculitis and meningitis (Part B, additional 10 patients).

Professor David Paterson, Director of ADVANCE-ID: “Carbapenem-resistant Acinetobacter baumannii (CRAB) has been classified as a “Critical” priority pathogen by WHO since 2017. BV100 is an attractive anti-infective which has already delivered very promising results in a Phase 2 VABP trial and we are very happy with the choice made by our independent expert panel. We look forward to collaborating with BioVersys, with our clinical trial network providing the infrastructure, expertise and access to a large population of patients with life-threatening CRAB infections. These are exactly the patients who need the kind of innovative anti-infective potential that BV100 represents.”

This Phase 2b open label randomized trial is expected to dose the first patient in H1 2026 and to include an interim data read-out in H2 2026. The data generated are expected to contribute to the BV100 Phase 3 program aimed at regulatory submission in the US, Europe and China.

The mission of ADVANCE-ID (ADVANcing Clinical Evidence in Infectious Diseases) is to conduct high-quality clinical trials that globally impact the management of infections. The network has already conducted clinical research in over 10,000 patients including over 3,000 in Ventilator Associated Bacterial Pneumonia (VABP) and Hospital Acquired Bacterial Pneumonia (HABP) and over 7,000 in Blood Stream Infections (BSI), finding that carbapenem-resistant Acinetobacter baumannii was the most common cause of these life-threatening infections across Asia. Wellcome originally supported the ADVANCED-ID set-up with funding in 2022 and has now provided a further 22 million SGD contribution to build clinical trial capacity and support this first Sponsor driven Phase 2 trial.

 

Alex Pym, Director of Infectious Disease at Wellcome: “To ensure new antibiotics work where they’re needed most, it’s essential they are tested in the countries with the highest levels of antimicrobial resistance (AMR). It’s very exciting to see this trial for a first-in-class new antibiotic being tested in the Southeast Asia region – one of the hardest hit by drug resistance, as highlighted in the WHO GLASS report. This will be vital to ensuring an equitable, effective approach to tackling the growing global threat of AMR. ADVANCE-ID, through fostering collaboration between academics, clinicians, and industry can accelerate innovation as well as building our capacity to reduce the impact of AMR worldwide, ultimately getting effective treatments to the communities and regions where they can have the biggest impact.”

 

Dr. Glenn Dale, Chief Development Officer of BioVersys:We are delighted that BV100 was selected by ADVANCE-ID to participate in their clinical trial network in Asia and for the outstanding commitment and support that Wellcome continues to show globally in the advancement of medicines addressing unmet human health challenges. BV100 has already demonstrated in its first Phase 2 trial the potential for a significant mortality benefit for patients with life-threatening CRAB infections. In this next Phase 2b trial, we aim to show a benefit over any currently available drug in real world conditions, which will provide further evidence of the value of BV100 to patients and health care systems. We are excited to collaborate with Professor Paterson and his team. This Phase 2b trial will add additional data to our global Phase 3 trial that is currently being initiated.”

About BV100

BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including Carbapenem-Resistant ABC (CRABC) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.

 

About Acinetobacter baumannii

Acinetobacter baumannii calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. ABC is considered a significant worldwide threat in the healthcare setting given its ability to survive for prolonged periods on surfaces, combined with its ability to develop or acquire resistance to standard of care antibiotics, e.g. carbapenems. Carbapenem-resistance as well as multidrug-resistance (MDR) rates for ABC are among the highest recorded for any bacteria in current times (The Lancet 2022; 399: 629–55). Incidence and resistance rates for ABC are trending upwards and COVID-19 has exacerbated this significantly. The WHO list CRAB as “critical” in the highest priority group. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates.

 

About ADVANCE-ID

ADVANcing Clinical Evidence in Infectious Diseases (ADVANCE-ID) is a clinical research network involving more than 50 hospitals across Asia, with a base at the National University of Singapore (NUS). The mission of ADVANCE-ID is to conduct high-quality clinical trials that have a global impact on management of infections. ADVANCE-ID was set up in March 2022 with a grant from Wellcome and funds from other institutions including, NUS Saw Swee Hock School of Public Health, NUS Yong Loo Lin School of Medicine, Duke-NUS Medical School, NTU Lee Kong Chian School of Medicine, and the National Centre for Infectious Diseases. 

Email: hello@advance-id.network Tel : +65 6516 4988  https://www.advance-id.network/

 

 

About National University of Singapore (NUS)

The National University of Singapore (NUS) is Singapore’s flagship university, which offers a global approach to education, research and entrepreneurship, with a focus on Asian perspectives and expertise. We have 15 colleges, faculties and schools across three campuses in Singapore, with more than 40,000 students from 100 countries enriching our vibrant and diverse campus community. We have also established more than 20 NUS Overseas Colleges entrepreneurial hubs around the world.

 

Our multidisciplinary and real-world approach to education, research and entrepreneurship enables us to work closely with industry, governments and academia to address crucial and complex issues relevant to Asia and the world. Researchers in our faculties, research centres of excellence, corporate labs and more than 30 university-level research institutes focus on themes that include energy; environmental and urban sustainability; treatment and prevention of diseases; active ageing; advanced materials; risk management and resilience of financial systems; Asian studies; and Smart Nation capabilities such as artificial intelligence, data science, operations research and cybersecurity.

For more information on NUS, please visit nus.edu.sg.

 

About Wellcome

Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.

Email: mediaoffice@wellcome.org Tel: +44 (0)20 7611 8866, https://wellcome.org  

 

About BioVersys

BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland.

BioVersys contact

Hernan Levett, CFO, Tel. +41 61 633 22 50; Mail: Hernan.levett@bioversys.com

For Media: media@bioversys.com

www.bioversys.com

 

 

 

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

 

Biotest AG: Extraordinary general meeting convened again at the request of Grifols S.A.

Biotest AG

/ Key word(s): AGM/EGM

Biotest AG: Extraordinary general meeting convened again at the request of Grifols S.A.

07.11.2025 / 15:19 CET/CEST

The issuer is solely responsible for the content of this announcement.


 

PRESS RELEASE

 

Biotest AG: Extraordinary general meeting convened again at the request of Grifols S.A.

 

  • Renewed request for convocation dated 21 October 2025
  • Resolution on the change of legal form to a partnership limited by shares (KGaA)

Dreieich, 7 November 2025. Biotest AG announces that, after careful consideration, the Management Board has deemed admissible the new request received in writing from Grifols S.A. on 28 October 2025 pursuant to Section 122 (1) of the German Stock Corporation Act (AktG) to convene an extraordinary general meeting to resolve on the change of legal form of the company to a partnership limited by shares (KGaA). In compliance with the statutory requirements, the Management Board, with the approval of the Supervisory Board, has decided to convene an extraordinary general meeting of Biotest AG for 17 December 2025. The invitation to the extraordinary general meeting with further details was published today in the Federal Gazette and on the company’s website.

On the agenda of the extraordinary general meeting on 17 December 2025 will be again the resolution on the change of legal form of Biotest AG to a partnership limited by shares (KGaA) under the name Biotest GmbH & Co. KGaA. It is planned that Biotest Management GmbH, in which Grifols S.A. indirectly holds all shares, will assume the position of general partner.

The items of another request for addition to the agenda received by the company were also put on the agenda.

 

About Biotest

Biotest is a provider of biological therapeutics derived from human plasma. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology 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 haematopoietic systems. Biotest has more than 2,500 employees worldwide. Since May 2022, Biotest has been a part of the Grifols Group, based in Barcelona, Spain (www.grifols.com).

 

IR contact

Dr Monika Baumann (Buttkereit)

Phone: +49-6103-801-4406
Mail: ir@biotest.com

 

PR contact

Miriam Oehme

Phone: +49 -152 07016 992
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: 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.Über Biotest

Biotest ist ein Anbieter von biologischen Arzneimitteln, die aus menschlichem Plasma gewonnen werden. Mit einer Wertschöpfungskette, die von der vorklinischen und klinischen Entwicklung bis zur weltweiten Vermarktung reicht, hat sich Biotest vorrangig auf die Anwendungsgebiete Klinische Immunologie, Hämatologie und Intensiv- und Notfallmedizin spezialisiert. Biotest entwickelt und vermarktet Immunglobuline, Gerinnungsfaktoren und Albumin, die auf Basis menschlichen Blutplasmas produziert werden und bei Erkrankungen des Immunsystems oder der blutbildenden Systeme zum Einsatz kommen. Biotest beschäftigt weltweit mehr als 2.500 Mitarbeiter. Seit Mai 2022 ist Biotest Teil der Grifols Gruppe, Barcelona, Spanien (www.grifols.com).

 


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2225420  07.11.2025 CET/CEST