Drägerwerk AG & Co. KGaA: Preliminary figures Q3 2025: Significant increase in net sales and earnings – upper half of forecast range expected

Drägerwerk AG & Co. KGaA / Key word(s): Preliminary Results/Forecast

Drägerwerk AG & Co. KGaA: Preliminary figures Q3 2025: Significant increase in net sales and earnings – upper half of forecast range expected

15-Oct-2025 / 19:24 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group.

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


Ad-hoc notification in accordance with Sec. 17 of the MAR

Drägerwerk AG & Co. KGaA: Preliminary figures Q3 2025: Significant increase in net sales and earnings – upper half of forecast range expected

Lübeck, October 15, 2025 – Based on preliminary calculations, Dräger increased its net sales in the third quarter of 2025 by 10.1 percent (net of currency effects; nominal: 7.6 percent) to around EUR 833 million (Q3 2024: EUR 774.6 million). Both divisions recorded significant growth again after a decline in the prior year. The medical division saw an increase of 10.2 percent (net of currency effects; nominal: 7.3 percent) to around EUR 471 million (Q3 2024: EUR 439.1 million), while the safety division grew by 9.9 percent (net of currency effects; nominal: 7.9 percent) to around EUR 362 million (Q3 2024: EUR 335.5 million). The Group’s gross margin rose to around 45.6 percent (Q3 2024: 43.5 percent).

Earnings before interest and taxes (EBIT) increased to around EUR 57 million, more than doubling (Q3 2024: EUR 24.4 million). In the same quarter of the prior year, EBIT had been still supported by a positive one-off effect amounting to around EUR 10 million. The main reason for the good earnings performance in the third quarter of 2025 was the significant growth in net sales, while costs rose only moderately. The EBIT margin improved by 3.7 percentage points to 6.8 percent (Q3 2024: 3.1 percent).

Order intake rose by 6.9 percent in the third quarter (net of currency effects; nominal: 4.9 percent) to around EUR 856 million (Q3 2024: EUR 816.2 million). In the medical division, it increased by 5.4 percent (net of currency effects; nominal: 3.5 percent) to around EUR 485 million (Q3 2024: EUR 468.4 million) following a decline in the prior year. In the safety division, order intake grew by 8.8 percent (net of currency effects; nominal: 6.8 percent) to around EUR 371 million (Q3 2024: EUR 347.8 million).

Business performance in the first nine months of 2025
Order intake rose by 9.0 percent (net of currency effects; nominal: 7.2 percent) to around EUR 2,594 million in the first nine months. This not only exceeded the prior year’s high level (9 months 2024: EUR 2,420.5 million), but also reached the highest nine-month level since the record year of 2020. Both divisions contributed to this positive development: in the medical division, order intake increased significantly by 11.6 percent (net of currency effects; nominal: 9.3 percent) after a decline in the prior year to around EUR 1,496 million (9 months 2024: EUR 1,368.5 million); this was partly due to a major multi-year order from Mexico in the mid double-digit million euro range, which Dräger received in the second quarter. In safety division, order intake in the first nine months rose by 5.7 percent (net of currency effects; nominal: 4.4 percent) to around EUR 1,099 million (9 months 2024: EUR 1,052.1 million).

Net sales increased by 3.7 percent (net of currency effects; nominal: 2.1 percent) to around EUR 2,344 million (9 months 2024: EUR 2,295.1 million). Following a decline in the prior year, the medical division recorded growth of 4.7 percent (net of currency effects; nominal: 2.9 percent) to around EUR 1,322 million (9 months 2024: EUR 1,285.3 million). The safety division grew by 2.4 percent (net of currency effects; nominal: 1.1 percent) to around EUR 1,021 million (9 months 2024: EUR 1,009.7 million). The Group’s gross margin rose to around 45.1 percent (9 months 2024: 44.4 percent).

At around EUR 77 million, EBIT did not reach the prior year’s figure (9 months 2024: EUR 80.1 million), but this was mainly due to the positive one-off effects in the prior year: In the second quarter of 2024, Dräger sold a non-strategic business area in the Netherlands and a property in the U.S. for a total of around EUR 20 million in addition to the sale of a building in Spain for around EUR 10 million in the third quarter of 2024. These earnings contributions are now missing. Currency effects and customs duties also had a negative impact on earnings in the first nine months of 2025. The EBIT margin amounted to around 3.3 percent (9 months 2024: 3.5 percent).

Forecast for 2025: Net sales and EBIT margin expected to be rather in the upper half of the range
Due to the very good business performance and the continued high order intake, we now tend to expect net sales growth of 3.0 to 5.0 percent net of currency effects (previously 1.0 to 5.0 percent net of currency effects) and an EBIT margin of 4.5 to 6.5 percent (previously 3.5 to 6.5 percent).

The full results for the first nine months of the fiscal year will be published on October 29, 2025.

 

Drägerwerk AG & Co. KGaA
Moislinger Allee 53–55
23558 Lübeck, Germany
www.draeger.com

 

Investor Relations:
Thomas Fischler
Tel. +49 451 882-2685
thomas.fischler@draeger.com

 

Corporate Communications:
Melanie Kamann
Tel. +49 451 882-3998
melanie.kamann@draeger.com

 

Disclaimer
This ad hoc report contains statements on the future development of Dräger Group. These forward-looking statements are based on the current expectations, presumptions, and forecasts of the Executive Board as well as the information available to date. They were compiled to the best of the company’s knowledge. Dräger does not provide any warranty nor assume any responsibility for the future developments and results described above. These are dependent on a number of factors. They entail various risks and contingencies outside of the company’s influence and are based on assumptions which could prove to be incorrect. Dräger does not assume any responsibility for updating the forward-looking statements contained in this report. This does not infringe any legal stipulations on the adjustment of forecasts. Please go to Investor Relations / Definitions of financial indicators at www.draeger.com for information on alternative performance measures used.

End of Inside Information


15-Oct-2025 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Language: English
Company: Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
23558 Lübeck
Germany
Phone: +49 (0)451 882-0
Fax: +49 (0)451 882-2080
E-mail: info@draeger.com
Internet: www.draeger.com
ISIN: DE0005550602, DE0005550636 (Vorzugsaktien)
WKN: 555060, 555063 (Vorzugsaktien)
Indices: SDAX, TecDax
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Stuttgart, Tradegate Exchange
EQS News ID: 2213782

 
End of Announcement EQS News Service

2213782  15-Oct-2025 CET/CEST

bonyf AG receives the EU-MDR Certification Class IIa for PerioCream

bonyf NV

/ Key word(s): Product Launch/Incoming Orders

bonyf AG receives the EU-MDR Certification Class IIa for PerioCream

15-Oct-2025 / 15:23 CET/CEST


bonyf AG receives the EU-MDR Certification Class IIa for PerioCream

    

Knokke-Heist (Belgium), 15 October 2025, 6:00 a.m.; bonyf NV (Euronext Paris Ticker: MLBON), a leader in dental consumer goods, professional dental consumables and dermatological solutions, announces today that its brand, PerioCream, a mucoadhesive formulation based on NitrAdine®, applied by dental professionals as an adjunct to Scaling & Root Planing (SRP) has been granted a certification as a Class IIa medical device according to Medical Device Regulation (EU) 2017/745 Annex IX Chapter I+III.

The certification, issued by DEKRA Certification GmbH, Germany, Notified Body (ID Number: 0124) on September the 17th, 2025, releases PerioCream Periodontal Paste to dental professionals and practitioners across the world.

The Medical Device Regulation (EU) 2017/745 is one of the world’s most robust health tech regulations, and it plays a vital role in ensuring medical devices meet the highest standards.

It has replaced the Medical Device Directive (MDD) and brings a series of important improvements to conformity assessment for medical devices with the scope to ensure the quality, safety, performance and reliability of medical devices placed on the European Market; strengthen transparency of information related to medical devices for consumers and practitioners; enhance vigilance and market surveillance of devices in use. DEKRA Certification GmbH based in Germany with worldwide presence, is the notified Body of bonyf AG. We got the MDR certification from DEKRA including PerioCream, based on the sampling plan for reviews of class IIa devices.

For the UK market, European CE marking is currently accepted until specified deadlines and product risk classification. A UKRP (UK Representative) was already designated, and UK resellers can contact bonyf AG to obtain more information.

For the US market, bonyf AG initiated the certification process with FDA and currently bonyf AG is on track with expected certification by the US FDA beginning 2026.

What is PerioCream?

PerioCream Periodontal Paste is an adjunct to scaling and root planing (SRP) treatment applied by dental professionals on the gum line. PerioCream Periodontal Paste acts as a protective barrier by isolating inflamed gingiva and irritated oral tissues to prevent bacterial recolonization, help reduce bleeding and enhance natural healing. The product is clinically proven to significantly reduce pain after SRP, enhance patient comfort and improve the overall SRP experience.

About bonyf

bonyf NV is a Belgian Euronext Paris listed company (Ticker: MLBON) specialized in the development and distribution of high-quality oral and denture care products, serving both professional and consumer markets. Through its fully owned subsidiaries bonyf AG (Liechtenstein) and bonyf Production AG (Switzerland), the company is accelerating its international reach. With a focus on innovation, sustainability, and clinical performance, bonyf is rapidly expanding its footprint across Europe and North America.

Annex to the EU Certificate no. 50537-60-00-02

Cureus Journal of Medical Science

ResearchGate

European Institute for Medical Studies (EIMS), St. Julian’s, Malta

 

bonyf’s strengths

  • Products with patented formulations
  • Produced in Switzerland compliant with stringent international quality regulations
  • Proven clinical efficacy
  • Commercial presence in 37 countries
  • Prospects for solid growth and rapid profitability
  • A fast-growing oral and dental care market

 

About bonyf

bonyf is a European innovator in oral and dermatological care, developing clinically validated solutions for dental professionals, pharmacies, and consumers. Listed on Euronext Paris (MLBON), bonyf is headquartered in Knokke, Belgium, and operates with a growing global presence across Europe, Asia, and the Americas.

 

For more information, visit bonyf.com or contact investor@bonyf.com.

bonyf

Jean-Pierre Bogaert

investor@bonyf.com

 


Attachment

File: EN_PR_bonyf AG receives the EU-MDR Certification Class IIa for PerioCream.


Dissemination of a Financial Wire News, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.



2213580  15-Oct-2025 CET/CEST

Cabinet decision on the Medical Cannabis Act meets broad criticism / Cantourage expects changes and prepares to expand its “Telecan” platform

Cantourage Group SE

/ Key word(s): Market Report

Cabinet decision on the Medical Cannabis Act meets broad criticism / Cantourage expects changes and prepares to expand its “Telecan” platform

15.10.2025 / 15:49 CET/CEST

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


Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Australia, Canada or Japan or any other jurisdiction in which such release, publication or distribution would be unlawful. The important notes at the end of this announcement must be observed.

Berlin, 15 October 2025 – The Cabinet draft to amend the Medical Cannabis Act (MedCanG) triggered widespread media coverage last week—predominantly critical. The Federal Ministry of Health (BMG) plans to prohibit initial prescriptions of medical cannabis flowers via telemedicine and to introduce a ban on mail‑order dispensing of cannabis by pharmacies.

General‑interest and trade media have in some cases reacted sharply to the proposals. DIE ZEIT argues the measures target “the wrong people” and could significantly impede patient care.[1] In Pharmazeutische Zeitung, the German Association of Mail‑Order Pharmacies calls the planned shipping ban “overshooting the mark” and is counting on corrections during the parliamentary process.[2] DER SPIEGEL describes the BMG’s proposal as “nonsensical,” assuming that criminals would be the main beneficiaries of the planned changes.[3] Dissent is also emerging within the governing coalition: Carmen Wegge, legal policy spokesperson of the SPD parliamentary group, and Dr. Christos Pantazis, the group’s health policy spokesperson, labelled the draft on Instagram as “not acceptable”—among other reasons because it discriminates against patient groups and violates European law. [4]

Medical cannabis is displacing the black market

“We welcome—and share—the widespread criticism from the media and policymakers of the planned legislative changes. As we set out in our statement this summer, the MedCanG in its current form undoubtedly has room for improvement,” says Philip Schetter, CEO of Cantourage. “And yet, over the past 18 months it has enabled hundreds of thousands of patients to begin cannabis therapy. Most of these people previously obtained cannabis on the black market—exactly where they would be pushed back if the BMG’s proposal were implemented, because otherwise there still is no functioning legal supply routes for cannabis. Criminals across Germany would be delighted. We are confident, however, that the upcoming parliamentary process will bring substantial changes to the BMG’s proposal.”

Committee and stakeholder hearings in parliament can, as experience shows, lead to substantive amendments to draft legislation—especially when, as is currently the case, legal and health‑policy objections have been raised. Moreover, the first interim report from the evaluation of the Cannabis Use Act (EKOCAN) reached the preliminary conclusion that there is currently no urgent need for action with respect to cannabis legalisation.[5]

Also feeding into the process is an online petition currently before the German Bundestag calling for a halt to the planned changes to the medical cannabis law. With over 32,000 co‑signatures (as of 15 October 2025), the petition enjoys broad public support.[6] Cantourage expressly supports the petition and calls on everyone to sign in order to prevent a resurgence of the cannabis black market in Germany.

Keep virtual first consultations and mailorder dispensing possible

Philip Schetter demands: “A mandatory initial consultation between doctor and patient with clear quality standards is definitely a sensible legislative adjustment—there is broad consensus on this across the industry. However, it must also be possible to conduct this consultation virtually. At our in‑house telemedicine provider ‘Telecan’, this has always been standard practice and has proven itself in everyday care.”

Schetter, by contrast, calls for the complete deletion of the proposed pharmacy shipping ban: “Because of the wide range of strains and effect profiles, cannabis flower is a highly specialized field. Of the roughly 17,000 pharmacies in Germany, only a few hundred deal with the topic in any significant way—a shipping ban would make access to cannabis products virtually impossible for many people.”

Cantourage will further optimize its telemedicine offering “Telecan” over the coming months in anticipation of possible changes. The platform for cannabis therapies already meets all requirements of the German medical professional code of conduct for physicians and has seen an increase in new registrations since the planned legislative changes became known.

Cantourage will continue to closely monitor the legislative process and provide updates on the next steps.

Sources (all in German):
[1]DIE ZEIT, „Kein Gras mehr im Sommerschlussverkauf“ (08.10.2025).
[2]Pharmazeutische Zeitung, „Cannabis‑Versandverbot ‘nicht im Sinne der Apotheken’“ (09.10.2025).
[3]DER SPIEGEL, „Der unsinnige Kampf gegen Gras auf Rezept“ (10.10.2025).
[4]Carmen Wegge und Dr. Christos Pantazis on Instagram: „Kein Rückschritt bei Patient:innenrechten!“ (10.10.2025).
[5]Universität Hamburg, „Evaluation des Konsumcannabisgesetzes (EKOCAN): 1. Zwischenbericht“ (29.09.2025).
[6]Deutscher Bundestag, petition „Geplante Änderungen des medizinischen Cannabis-Gesetzes stoppen“.

 

About Cantourage
Cantourage is a leading European company for the production and distribution of medical cannabis. Cantourage enables growers worldwide to sell products in European medical markets. Founded in 2019, the company works with more than 60 cannabis growers from 18 countries. Cantourage ensures the highest pharmaceutical quality standards along the value chain and offers products in all relevant market segments: dried flowers, extracts, dronabinol and cannabidiol. The company has been listed on the Frankfurt Stock Exchange since November 11, 2022, under the ticker symbol “HIGH”.

Contact Investor Relation
ir@cantourage.com

This announcement does not constitute an offer to the public or a solicitation of anoffer to sell securities to the public, in particular not within the meaning of Regulation (EU) 2017/1129 (Prospectus Regulation).


15.10.2025 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.
Archive at www.eqs-news.com


Language: English
Company: Cantourage Group SE
Feurigstraße 54
10827 Berlin
Germany
E-mail: info@cantourage.com
Internet: https://www.cantourage.com/
ISIN: DE000A3DSV01
WKN: A3DSV0
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2213562

 
End of News EQS News Service

2213562  15.10.2025 CET/CEST

QUANTRO Therapeutics extends collaboration with Boehringer Ingelheim to address high unmet needs in cancer patients

QUANTRO Therapeutics GmbH

/ Key word(s): Agreement

QUANTRO Therapeutics extends collaboration with Boehringer Ingelheim to address high unmet needs in cancer patients

14.10.2025 / 10:00 CET/CEST

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


Press Release

QUANTRO Therapeutics extends collaboration with Boehringer Ingelheim to address high unmet needs in cancer patients

  • Extension of collaboration for two additional years follows successful completion of major high-throughput screening (HTS) campaign and identification of attractive hits for further development.
  • The aim of the partnership is to develop first-in-class drug candidates targeting cancer-associated transcription factors.
  • QUANTRO is eligible to receive success-based R&D, regulatory and commercial milestone payments up to an estimated total value of around € 500M.
  • Company to attend BIO-Europe 2025 in Vienna, November 3–5.

Vienna, Austria, 14 October 2025: QUANTRO Therapeutics (QUANTRO), a technology leader in the discovery of first-in-class transcription factor targeting cancer treatments, is pleased to announce the extension of its strategic collaboration with Boehringer Ingelheim. Building on the progress made during the first phase, based on an agreement signed in 2022, this extension for two additional years will further advance the joint R&D program aiming to develop first-in-class drug candidates targeting cancer-associated transcription factors.

Cancer remains one of the leading causes of death worldwide, with a high unmet need for novel and effective treatments. Despite advancements in cancer therapy, many patients still face limited options and poor outcomes. This partnership aims to address these challenges by developing innovative therapeutics that target underlying mechanisms of cancer previously considered undruggable.

“We are excited to continue the successful collaboration with Boehringer Ingelheim to achieve our joint goal of transforming the lives of people living with cancer,” said Dr. Michael Bauer, CEO of QUANTRO. “The identification of functionally validated hits for difficult to drug transcription factor targets, using our HTS screening platform, confirms the precision, impact and maturity of our innovative time-resolved transcriptomics platform. We look forward to further pushing the boundaries of what is possible in transcriptomic drug discovery.”

Transcription factors are central regulators of gene expression and play a key role in the development and progression of cancer. Despite their relevance, they have remained largely inaccessible to drug development due to technical limitations and lacking precision of conventional assay techniques. These are incapable of adequately identifying direct transcriptional responses caused by drug treatments at early time-points, i.e. one hour after dosing. QUANTRO’s proprietary, time-resolved transcriptomics platform overcomes these limitations by enabling the precise characterization of transcriptional responses over time, thereby revealing actionable disease-driving mechanisms.

So far, Quantro has achieved technical proof-of-concept, cross-validation of its HTS screening technology, and the identification of functionally validated hits against previously undruggable transcription factors. This was followed by the successful completion of the company’s largest transcriptomic dual-target screening campaign to date, evaluating over 350,000 compounds to identify candidates specifically targeting selected transcription factors.

Now, QUANTRO will continue to apply its time-resolved transcriptomics platform to jointly advance the discovery of first-in-class small molecule inhibitors of selected oncogenic transcription factors.

Under the agreement with Boehringer Ingelheim, QUANTRO has already received payments and is eligible to receive further success-based R&D, regulatory and commercial milestone payments up to an estimated total value around € 500M. Further details of the collaboration terms were not disclosed.

QUANTRO retains full ownership of its technology platform and internal drug discovery programs targeting additional transcription factors beyond the scope of the collaboration.

Meet QUANTRO at BIO-Europe:

QUANTRO’s CEO Dr. Michael Bauer and Arianna Sabò, Head of R&D, will be attending BIO-Europe in Vienna from November 3–5, 2025 to engage with pharma partners and investors, showcasing the company’s latest progress with its transcriptomic drug discovery platform. Get in touch to schedule a meeting via the partnering system or through Contact | QUANTRO.

About QUANTRO:

QUANTRO Therapeutics is a transcriptomic Drug Discovery and R&D company focused on building a highly innovative pipeline of modulators, inhibitors or degraders of transcription factors, regulators of gene expression and cell signaling targets. QUANTRO’s transcriptomic discovery platform   uses a novel and proprietary time-resolved gene expression profiling technology to target gene transcription factors, so far considered un-druggable.

QUANTRO’s technology is uniquely positioned to quantify changes in gene expression over time with unprecedented precision and sensitivity, overcoming the deficiencies of traditional RT-qPCR based technologies like DRUG-seq, which are limited to only measure RNA abundance, without capturing information on transcriptional activity and dynamics.

QUANTRO was founded in 2019 as a spin-out from the prestigious research institutes IMBA and IMP in Vienna, Austria. Since 2020, the company has been supported by Boehringer Ingelheim Venture Fund (BIVF) and Evotec as seed investors, complemented by undisclosed proceeds from the ongoing strategic collaboration on selected oncology targets with Boehringer Ingelheim Oncology.

Please find more information on the website at www.quantro-tx.com or LinkedIn.

Contact
QUANTRO Therapeutics GmbH

Dr. Michael Bauer, CEO
Email: Contact | QUANTRO
Phone: +43 122 66001

Media Contacts
MC Services AG

Dr. Cora Kaiser, Dr. Johanna Kobler (international and German-speaking media inquiries)
Shaun Brown (international trade press)
Phone: +49 89 210228 0
Email: quantro@mc-services.eu


14.10.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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2212562  14.10.2025 CET/CEST

Together We Build: Rentschler Biopharma celebrates construction progress of new buffer media facility, largest single investment at Laupheim site

Rentschler Biopharma SE

/ Key word(s): Strategic Company Decision

Together We Build: Rentschler Biopharma celebrates construction progress of new buffer media facility, largest single investment at Laupheim site

13.10.2025 / 13:00 CET/CEST

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


Together We Build: Rentschler Biopharma celebrates construction progress of new buffer media facility, largest single investment at Laupheim site

  • Symbolic milestone for new buffer media station: Rentschler Biopharma underscores its commitment to the Laupheim headquarters and to the future of Germany and Europe as leading biotechnology hubs
  • Shaping dialogue: Panel discussion held with members of the Executive Board and a representative of the NXTGN innovation platform on key industry topics, including international competitiveness, partnerships, and the business environment in Germany

Laupheim (Germany), October 13, 2025 – With a time capsule ceremony and panel discussion on October 10th, Rentschler Biopharma SE celebrated the progress at its new buffer media station, which is currently under construction at the company’s headquarters in Laupheim. This project represents the largest single investment in the company’s history at the German site and marks an important contribution to strengthening the competitiveness of both Rentschler Biopharma and the biotechnology sector in Germany and Europe.

The highlight of the event was the symbolic placement of a time capsule at the new facility. It symbolizes Rentschler Biopharma’s commitment to scientific and technological progress and honors the contributions of employees and partners who made this milestone possible. The time capsule bears the message “Together We Build” – a symbol of shared responsibility for the future of healthcare. In a panel discussion, members of Rentschler Biopharma’s Executive Board, together with the Managing Director of the NXTGN Startup Factory, discussed how investments and innovation are shaping future viability and competitiveness in the biotech sector. Key topics included the attractiveness of Germany as a biotech hub and the importance of partnerships in driving innovation, competitiveness, and reliability of supply.

Benedikt von Braunmühl, Chief Executive Officer of Rentschler Biopharma, commented: “At Rentschler Biopharma, we invest with foresight in infrastructure that ensures stability and sustainable growth – always keeping in mind our clients and, above all, patients worldwide. The new buffer media station marks an important milestone in this regard and, as the largest single investment in our history at our headquarters, underscores our clear commitment to Laupheim as well as to Germany and Europe as leading biotech hubs. As an independent family-owned company, we have always taken a long-term, future-focused approach: We combine our strength in innovation with responsibility to ensure a sustainable future for Rentschler Biopharma. My sincere thanks go to all colleagues whose dedication and expertise have made this milestone possible.”

“Together We Build”: Celebrating construction progress with a time capsule ceremony and panel discussion

On October 10, 2025, Rentschler Biopharma celebrated the construction progress at the new buffer media station at its Laupheim headquarters with employees and guests, including politicians, business partners, and the press. A time capsule was placed in the new facility: Serving as a bridge between the present and a future full of potential, the robust steel box contained a sample of current buffer and media solutions, a rendering of the new building, messages from the site leadership in Laupheim and Milford (USA), and the company’s core values – a testament of its corporate culture. This tribute to the present was thus linked with a clear commitment to shaping the future.

Christiane Bardroff, Chief Operating Officer of Rentschler Biopharma, explained: “As a CDMO, it is our responsibility to support our global clients in transforming innovative ideas into life-saving biopharmaceuticals and enabling rapid market access for new therapies. With the new buffer media facility, we will be even better positioned to fulfill this responsibility: enhanced automation and digitalization will make our processes more efficient and secure, while providing employees with a state-of-the-art working environment. With additional capacity for buffer and media solutions, we are laying the foundation to respond flexibly to our clients’ growing needs while ensuring patients have reliable access to therapies.”

Dr. Michael Zyder, Managing Director of NXTGN, added: “Innovation requires reliability. Especially at a time when the future of Germany as a biotech hub is widely debated, the collaboration between Rentschler Biopharma and the NXTGN Startup Factory demonstrates what truly matters: a partnership of equals that connects novel ideas from research and start-ups with industrial implementation – strengthening Europe’s competitiveness and strategic sovereignty.”
 

About the new buffer media station

Buffer and media solutions are an essential foundation of biopharmaceutical production. By 2028, a new state-of-the-art buffer media station will be operational in Laupheim, located in a purpose-built four-story building covering 3,400 square meters. The facility will offer faster and more efficient processes, as well as ergonomically designed workstations, providing a modern working environment for employees. It will meet the highest automation and quality standards and, with its advanced equipment, will also contribute to Rentschler Biopharma’s environmental and sustainability goals.

Three media tanks and six buffer tanks will support the production of buffer and media solutions, with dedicated areas to meet the strictest hygiene and safety standards. In addition, the station will be connected to the in-house logistics system as well as to the piping systems for upstream and downstream processes within the existing infrastructure. The buffer media station is scheduled to become fully operational by 2028.

About Rentschler Biopharma SE

Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma’s high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,400 employees, headquartered in Laupheim, Germany, with operations in Milford, MA, USA. In 2024, the company joined the United Nations Global Compact, emphasizing Rentschler Biopharma’s focus on sustainability. For further information about the company, please visit www.rentschler-biopharma.com. Follow Rentschler Biopharma on LinkedIn.

Contact:  

Rentschler Biopharma
Dr. Latika Bhonsle-Deeng
Global Head of Communications
Phone: +49-7392-701-467
communications@rentschler-biopharma.com

Media inquiries:

MC Services AG
Eva Bauer
Phone: +49-89-210228-0
rentschler@mc-services.eu

U.S.
Laurie Doyle
Phone: +1-339-832-0752
 

High-res pictures can be downloaded from our press section following this link: https://www.rentschler-biopharma.com/en-us/news-events/presskit/press-images/.

User name: Press
Password: press2025!


13.10.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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2211250  13.10.2025 CET/CEST

Gerresheimer: FDA grants Approval of SQ Innovation’s Lasix® ONYU*

Gerresheimer AG

/ Key word(s): Regulatory Approval

Gerresheimer: FDA grants Approval of SQ Innovation’s Lasix® ONYU*

13.10.2025 / 10:00 CET/CEST

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


Gerresheimer: FDA grants Approval of SQ Innovation’s Lasix® ONYU*

  • Innovative combination product of furosemide and on-body device
  • Device designed, developed and manufactured by Gerresheimer
  • First products expected to be available already in 2025 

Duesseldorf, Germany, October 13, 2025. Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetics industries, announces that the US Food and Drug Administration (FDA) granted SQ Innovation approval for Lasix ONYU for treatment of edema in congestive heart failure. Lasix ONYU is a combination product consisting of a novel high-concentration formulation of the diuretic furosemide and the Gerresheimer on-body drug delivery device (infusor). It was developed to enable subcutaneous infusion of furosemide at home for selected patients, as prescribed by a clinician without the need for a healthcare professional to administer the drug. The cartridge-based infusor was designed and developed by Gerresheimer based on its proprietary infusor platform for subcutaneous drug delivery. Gerresheimer also manages production of the device as a full-service solution provider. First products of Lasix ONYU are expected to be available on the market already in 2025. The FDA’s approval of the combination product demonstrates Gerresheimer’s innovative strength and its strong partnership with customers, from product design to large-scale manufacturing.

“The FDA’s Approval is a testament to our product and the people and partners who have contributed to this large undertaking, most notably the Gerresheimer team”, says Pieter Muntendam, MD, Founder, President and CEO of SQ Innovation. “Lasix ONYU has the potential to be transformative in the care of patients experiencing worsening heart failure due to fluid overload. Treating selected patients at home offers important benefits to patients, health systems and payors.”

“The FDA’s decision underscores our expertise as an innovative solution provider for our customers, from product design to large-scale manufacturing”, says Dietmar Siemssen, CEO of Gerresheimer AG. “With our on-body devices for both small molecule drug formulations and large molecule biologics we can partner with our customers to address the global megatrend of home treatment, including providing connectivity to remote therapeutic monitoring platforms.”

Device based on Gerresheimer’s innovative micropump technology

The cartridge-based infusor was designed and developed by Gerresheimer based on its proprietary infusor platform for subcutaneous drug delivery. The core technology is an innovative micropump which enables controlled, precise administration of a drug product according to a defined therapy regimen.

Designed with patient comfort and the environment in mind

The lightweight, compact device is patched onto the patient’s body, making it comfortable for the patient to wear while the drug is gently infused. The user-friendly design features a simple one-button operation with automatic needle insertion and retraction. The Lasix ONYU infusor has two components, a reusable electromechanical component, and a single-use sterile disposable component that is in contact with the drug solution and the body. The reusable component, which is rated for delivery of 48 treatments with diuretic furosemide, is recyclable. Because only the disposable unit requires sterilization, radiation can be used instead of chemical sterilization, and no electronic components end up in medical waste. This two-component concept was developed in line with Gerresheimer’s EcoDesign principles, which aim to increase product lifespan and reduce waste.

Reducing total cost of care and improving patients’ quality of life

The combination product Lasix ONYU also opens up possibilities to reduce the total cost of care. The two-component design results in a lower cost per treatment, because only the disposable part of the device needs to be replaced. Most importantly, the infusor allows for home treatment, reducing the length of hospital stay or avoiding the need for hospitalization for intravenous diuretic administration altogether.

First products expected to be available already in 2025 

In addition to Gerresheimer’s role in design and development, Gerresheimer also manages production of the device as a full-service solution provider. The disposable unit for the infusor is, for example, produced at the Gerresheimer facility in Wackersdorf, Germany, on a high-capacity semi-automated line. Production commenced earlier this year in anticipation of approval and first products are expected to be available before the end of the year.

 

*Legal Notice
In the United States, the trademark Lasix® is used by SQ Innovation under license from Validus Pharmaceuticals L.L.C.   

 

Further information on Gx InPuls, Gerresheimer’s on-body device for small-molecule drugs: www.gerresheimer.com/en/gx-inpuls

 

About Gerresheimer 
Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The Group offers a comprehensive portfolio of drug containment solutions including closures and accessories, as well as drug delivery systems, medical devices and solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, cartridges, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. Gerresheimer supports its customers with comprehensive services along the value chain and in addressing the growing demand for enhanced sustainability. With over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. Together with Bormioli Pharma, the Group generated revenues of around EUR 2.4bn in 2024 and currently employs around 13,600 people. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).    
www.gerresheimer.com 

 

Contact Gerresheimer

Media  
Jutta Lorberg
Head of Corporate Communication
T +49 211 6181 264
jutta.lorberg@gerresheimer.com                            
Marion Stolzenwald
Senior Manager Corporate Communication
T +49 172 2424185
marion.stolzenwald@gerresheimer.com
 
Investor Relations
 
Guido Pickert
Vice President Investor Relations
T +49 211 6181 220
gerresheimer.ir@gerresheimer.com
 
Thomas Rosenke
Senior Manager Investor Relations
T +49 211 6181-187
gerresheimer.ir@gerresheimer.com


13.10.2025 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.

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Language: English
Company: Gerresheimer AG
Peter-Müller-Str. 3
40468 Duesseldorf
Germany
Phone: +49-(0)211/61 81-00
Fax: +49-(0)211/61 81-121
E-mail: gerresheimer.ir@gerresheimer.com
Internet: http://www.gerresheimer.com
ISIN: DE000A0LD6E6
WKN: A0LD6E
Indices: MDAX (Aktie)
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2211592

 
End of News EQS News Service

2211592  13.10.2025 CET/CEST

Biotest’s Yimmugo® launches in the United States

Biotest AG

/ Key word(s): Product Launch

Biotest’s Yimmugo® launches in the United States

09.10.2025 / 17:30 CET/CEST

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


PRESS RELEASE

 

Biotest’s Yimmugo® launches in the United States

 

Dreieich, Germany, October 9, 2025. Biotest AG, a specialist in innovative haematology, clinical immunology and intensive care medicine and part of Grifols, a global healthcare company and leading producer of plasma-derived medicines, proudly announces the official launch of Yimmugo®, its innovative intravenous polyvalent human normal immunoglobulin (IVIg) to treat primary immunodeficiencies, in the United States.

This is a significant milestone in the company’s global growth strategy and represents the first U.S.-approved medicine in Biotest’s portfolio.

This important achievement is made possible through the close collaboration with Kedrion Inc., a recognized leader in plasma-derived therapies, which will become Biotest’s U.S. distribution partner for this treatment.

A Breakthrough for Patients – A Milestone for Biotest
Yimmugo® is designed to meet critical patient needs in the treatment of primary immune deficiencies, which are believed to affect one in every 1,200 people in the United States. With its entry into the U.S. market—the world’s largest plasma protein market—Biotest reinforces its mission to improve and save the lives of patients worldwide.

Yimmugo® is produced in Biotest’s “Next Level” production facility in Dreieich, Germany, using a state-of-the-art manufacturing process. The treatment was successfully introduced in Europe at the end of 2022 and will now reach U.S. patients, following FDA approval in 2024.

“This launch is a major step forward in expanding access to treatment for U.S. patients living with primary immunodeficiencies. It also reinforces our commitment to broadening the reach of our therapies,” said Dr. Jörg Schüttrumpf, CEO of Biotest AG. “Our collaboration with Kedrion ensures that Yimmugo® reaches those who need it most, backed by Kedrion’s deep expertise and trusted commercial network in the United States.”

The U.S. launch of Yimmugo® represents a cornerstone in Biotest’s long-term strategy and highlights the company’s continuous growth trajectory. It demonstrates Biotest’s commitment to innovation, patient focus, and international expansion.

“With Yimmugo® now available in the U.S., Biotest takes a bold step into the future,” added Enrico D’Aiuto, Head of Commercial Operations at Biotest. “We are proud of this achievement, grateful to our teams and partners, and optimistic about the impact Yimmugo® will have on patients’ lives.”

 

About Biotest

Biotest is a supplier of biological medicines derived from human plasma. With a value chain ranging from preclinical and clinical development to global marketing, Biotest specialises primarily in the fields of clinical immunology, haematology and intensive care and emergency medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin, which are produced from human blood plasma and used to treat diseases of the immune system or the blood-forming systems. Biotest employs more than 2,500 people worldwide. Since May 2022, Biotest has been part of the Grifols Group, Barcelona, Spain (www.grifols.com).

IR contact:

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

PR contact:

Miriam Oehme
Telephone: +49 -152 07016 992
Email: pr@biotest.com

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

Ordinary shares: WKN: 522720; ISIN: DE0005227201
Preference shares: WKN: 522723; ISIN: DE0005227235
Listed: Open market: Berlin, Düsseldorf, Hamburg/Hanover, Munich, Stuttgart, Tradegate

 

Disclaimer
This document contains forward-looking statements on the overall economic development and the business, earnings, financial and asset situation of Biotest AG and its subsidiaries. These statements are based on the company’s current plans, estimates, forecasts and expectations and are therefore subject to risks and uncertainties that could cause the actual results to differ materially from the expected development. 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.

 


09.10.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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2210812  09.10.2025 CET/CEST

SYNLAB expands investment in Italy with opening of flagship Medical Centre in Florence

SYNLAB

/ Key word(s): Expansion

SYNLAB expands investment in Italy with opening of flagship Medical Centre in Florence

09.10.2025 / 15:00 CET/CEST

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


New SYNLAB Manifattura Firenze Medical Centre marks a milestone in the Group’s international growth strategy, strengthening local healthcare through innovation and care excellence

SYNLAB, a leader in medical diagnostic services and specialty testing in Europe, officially inaugurated its largest medical centre in Italy today: SYNLAB Manifattura Firenze. Located in the heart of one of Italy’s most ambitious urban regeneration projects, the new centre is a strategic investment in the future of healthcare, combining cutting-edge diagnostics, patient-centred care and sustainable infrastructure.
Spanning over 4,000 square metres across four floors, the centre is designed to serve over 200,000 patients annually. It is equipped with the latest diagnostic technologies and offers a comprehensive range of services, including laboratory testing, advanced imaging, specialist consultations, and a dedicated women’s health area. Over 80 healthcare professionals will work at the facility, which is fully integrated into SYNLAB’s regional network in Tuscany, comprising over 40 blood collection points, ten medical centres and a central laboratory in Calenzano.

“The opening of SYNLAB Manifattura Firenze is a powerful demonstration of our commitment to advancing high-quality, highly specialised diagnostics across our global network. From Europe to Latin America, SYNLAB enables personalised medicine by combining cutting-edge technology, medical excellence and a deep understanding of local healthcare needs. This new centre reflects our ambition to deliver sustainable, patient-focused solutions that support healthier lives wherever we operate, and represents another significant milestone in our international journey” said Mathieu Floreani, CEO of SYNLAB Group.

The facility was designed with a strong focus on patient experience, sustainability and efficiency. Built in just over two years, it meets the highest environmental standards, with energy-saving systems, reduced emissions, and optimised patient flows to ensure comfort and care continuity.
The opening of the Florence centre follows a series of strategic developments by SYNLAB in Italy, including the recent acquisition of the Pavanello Group, a well-established diagnostics provider in the Veneto region. These investments reflect SYNLAB’s long-term commitment to expanding its presence and enhancing healthcare access across the country.

“We believe that innovation and proximity go hand in hand,” said Andrea Buratti, CEO of SYNLAB Italy. “With Manifattura Firenze, we are creating a space where people feel welcomed, supported, and empowered to take care of their health – from prevention to diagnosis and beyond.”

– End –

For more information:

Media contact:
Steffi Susan Kim, FTI Consulting
steffi.kim@fticonsulting.com
+49 (0) 171 5565 996
Investor contact: ir@synlab.com

About SYNLAB

  • SYNLAB Group is a leader in medical diagnostic services and specialty testing in Europe. The Group offers a full range of innovative and reliable medical diagnostics to patients, practising doctors, hospitals and clinics, governments, and corporates.
  • Providing the leading level of service within the industry, SYNLAB is the partner of choice for routine and specialty diagnostics in human medicine. The Group continuously innovates medical diagnostic services for the benefit of patients and customers.
  • SYNLAB operates in more than 20 countries across four continents and holds leading positions in most markets, regularly reinforcing the strength of its network through a proven acquisition strategy. More than 24,000 employees, including over 2,000 medical experts, contribute every day to the Group’s worldwide success.
  • SYNLAB performed around 600 million laboratory tests and achieved revenues of €2.62 billion in 2024.
  • More information can be found on www.synlab.com


09.10.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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2210638  09.10.2025 CET/CEST

Heidelberg Pharma Reports on the First Nine Months of Financial Year 2025

Heidelberg Pharma AG

/ Key word(s): Quarterly / Interim Statement

Heidelberg Pharma Reports on the First Nine Months of Financial Year 2025

09.10.2025 / 07:03 CET/CEST

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


Heidelberg Pharma Reports on the First Nine Months of Financial Year 2025

  • Leading ADC candidate HDP-101 continues to demonstrate favorable safety and tolerability profile; clinical trial progresses into ninth cohort with increased dose of 175 µg/kg
  • Delay in significant milestone payment leads to extensive cost-saving measures, including a 75% reduction in workforce and focus on leading ADC project HDP-101
  • Presentation of new clinical data of HDP-101 at the International Myeloma Society (IMS) Annual Meeting; several patients from cohort 8 show initial objective efficacy after only a few doses
  • Adjustment of guidance following strategic focus

Ladenburg, Germany, 9 October 2025 – Heidelberg Pharma AG (FSE: HPHA) reported today on its operational progress as well as on the Group’s financial figures for the first nine months of fiscal year 2025 (1 December 2024 – 31 August 2025).

Professor Andreas Pahl, CEO of Heidelberg Pharma AG, commented: “In light of the delayed milestone payment, we have decided to prioritize our projects and implement a comprehensive cost-saving program. We deeply regret having to take these measures and would like to thank all affected colleagues for their many years of commitment, dedication, and valuable contributions to Heidelberg Pharma.

The measures we’ve decided on also affect our guidance, which we adjusted a few days ago.

The clinical development of our leading project HDP-101 remains promising. In cohorts 5 to 8, we observed an overall response rate of 36%, and in cohort 8, the preliminary overall response rate is 50%. HDP-101 has a strong safety and tolerability profile, and these data underscore the therapeutic potential of HDP-101 in heavily pretreated patients with relapsed or refractory multiple myeloma.”

Key operational developments within the company and among its partners

  • Developments at partner Telix unrelated to the ATAC technology: On 27 August 2025, partner Telix Pharmaceuticals Limited, Melbourne, Australia (Telix) received a Complete Response Letter (CRL) from the FDA for the diagnostic agent TLX250-CDx. The FDA identified deficiencies in the CMC (Chemistry, Manufacturing and Controls) package. According to Telix, the company immediately began addressing the deficiencies and will promptly request a Type A meeting with the FDA. New timelines will be communicated as soon as they are available.
    Under the license agreement with Telix, Heidelberg Pharma is entitled to milestone payments and double-digit royalties if the product receives marketing approval. In 2024, Heidelberg Pharma sold a portion of the future royalties to HealthCare Royalty (HCRx) and is entitled to receive USD 70 million from HCRx following FDA approval of TLX250-CDx, with reductions if approval is granted after the end of 2025. As the payment condition has not yet been met, the milestone payment is delayed accordingly.
  • Strategic focus and cost-saving measures: Due to the delayed milestone payment, Heidelberg Pharma announced on 25 September 2025, after the end of the reporting period, a comprehensive program to streamline operations and reduce costs. As the milestone payment from HCRx is still expected, but delayed and potentially lower than anticipated, this measure was necessary to extend the company’s cash runway.
    In the future, Heidelberg Pharma will focus on the further development of its lead ADC candidate HDP-101, which is currently in a Phase I/IIa clinical trial. The second clinical program, HDP-102, will be temporarily paused. For the third ADC, HDP-103, the company still plans to prepare the documentation for a clinical trial application.
    Early research activities will be phased out. Heidelberg Pharma will explore opportunities to out-license its preclinical programs.
    The current workforce will be reduced companywide by approximately 75% by mid-2026.
  • HDP-101 development program: HDP-101, an Amanitin-based antibody-drug conjugate targeting the BCMA antigen, is being tested in a Phase I/IIa open-label, multicenter study for the treatment of relapsed or refractory multiple myeloma, a cancer of the bone marrow. The first part of the study is a Phase I dose escalation study to determine the safe and optimal dosage of HDP-101 for the Phase IIa part of the study. The first eight patient cohorts and dose levels were completed with no evidence of dose-limiting toxicities.
    The eighth cohort, with a dose of 140 µg/kg, proved to be safe and well tolerated. All patients were dosed and have completed the observation period. HDP-101 consistently demonstrated a very good safety and tolerability profile. In addition, there are promising signs of clinical efficacy. In half of the patients, initial efficacy was observed after the first doses. Two patients achieved partial response and one patient achieved very good partial response. This builds on earlier positive results, including a patient from cohort 5 who had previously undergone several different therapies and has now achieved complete response with no detectable tumor cells while on ongoing monotherapy with HDP-101. In addition, several patients from different cohorts showed objective improvements and promising antitumor activity, further supporting the therapeutic potential of HDP-101 in heavily pretreated patients with relapsed or refractory multiple myeloma.
    Based on these results, the Safety Review Committee recommends continuing the study in cohort 9 with an increased dose of 175 µg/kg in one dosing arm. The cohort has already been started, and the first patient dosed.
  • HDP-102 development program: HDP-102 is an ADC targeting CD37, which is overexpressed on B-cell lymphoma cells. Preclinical studies have shown excellent anti-tumor efficacy in in vivo studies as well as good tolerability. Heidelberg Pharma intends to develop HDP-102 for specific indications of non-Hodgkin lymphoma.
    At the end of May, Heidelberg Pharma announced the dosing of the first patient with HDP-102. Three patients were treated with 40 µg/kg in the first cohort. Initial data showed promising results. The treatment is well tolerated, and initial signs of biological activity were observed even at the very low dose. Two patients showed stabilization of the disease with regression and reduction of lymph nodes. The safety committee recommended increasing the dose of HDP-102 to 65 µg/kg in cohort 2.
    Due to the current financial situation of the company, the study is being temporarily paused, and no further cohorts are being opened at this time. Patients in cohort 1 will continue to be treated with HDP-102 as long as there is no progression of the disease.
  • HDP-103 development program: HDP-103 is being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The antibody used binds to PSMA, a membrane antigen that is overexpressed on prostate cancer cells. It is a promising target for ATAC technology as it has limited expression in normal tissues.
    The clinical team is working on the study application for a Phase I clinical trial. As part of the current focus, partners are being sought for the clinical development of HDP-103 outside China. This does not affect the development cooperation with Huadong in its license territory.
  • HDP-104 and HDP-201 development program: The ADC projects HDP-104 and HDP-201 target guanylyl cyclase-C (GCC), a receptor that is expressed on the surface of intestinal cells and cancer cells in various gastrointestinal tumors. HDP-104 uses Amanitin as its payload, while HDP-201 uses the topoisomerase inhibitor exatecan. Heidelberg Pharma is currently not pursuing further development of either project, and is seeking a partnership.

Events after the end of the reporting period

  • New clinical data on HDP-101 presented at International Myeloma Society Annual Meeting 2025: At the Annual Meeting of the International Myeloma Society (IMS) in Toronto, Canada, in mid-September, Professor Jonathan L. Kaufman, clinical investigator for the study and David Bankes Glass Professor, Department of Hematology and Medical Oncology, Emory University, Atlanta, USA, presented new results from eight patient cohorts in the ongoing study evaluating HDP-101 in multiple myeloma. In cohort 8, HDP-101 consistently demonstrated a very good safety and tolerability profile and encouraging signs of clinical efficacy. Biological activity of HDP-101 was observed in several patients, and one patient has already achieved very good partial remission.

Adjustment of the risk and opportunity report

Financial risks – Liquidity – Risk of insolvency

An expected milestone payment of USD 70 million from HCRx did not materialize, as the payment condition – market approval of the diagnostic agent TLX250-CDx by the FDA – is currently not fulfilled. The lack of cash inflow jeopardizes the continued existence of the Group and/or the consolidated companies.

To enable the companies of the Heidelberg Pharma Group to meet their payment obligations, a decision was made on 25 September 2025, to strategically focus on the leading ADC candidate HDP-101, discontinue all early-stage research activities, and reduce the workforce by 75%.

Once these measures have been implemented and based on the current planning, the company’s financing range will be extended until mid-2026.

In addition to the liquidity risk that threatens the company’s existence, it cannot be ruled out that other risks, including general risks (business model) and financial risks (impairment of short- or long-term assets) will also increase.

Results of operations, financial position and net assets

The Heidelberg Pharma Group, as of the reporting date consisting of Heidelberg Pharma AG and its three subsidiaries Heidelberg Pharma Research GmbH, HDP G250 AG & Co. KG, and HDP G250 Beteiligungs GmbH, reports consolidated figures. The two latter companies, which were newly established in the previous year, are not operationally active and affiliated to the parent company like Heidelberg Pharma Research GmbH.

The reporting period referred to below relates to the period from 1 December 2024 to 31 August 2025 (9M 2025).

In the first nine months of the 2025 financial year, the Group generated sales revenues and income totaling EUR 6.4 million (previous year: EUR 7.6 million) and is in line with the updated planning. The sales revenues included in this figure fell from EUR 5.2 million the previous year to EUR 1.4 million. Other income amounted to EUR 5.0 million and was thus significantly higher than the previous year’s level of EUR 2.4 million due exchange rate gains (EUR 3.2 million).

Operating expenses, including depreciation, amounted to EUR 28.2 million in the reporting period (previous year: EUR 22.8 million) and are broken down as follows: Cost of sales decreased to EUR 0.2 million (previous year: EUR 1.5 million) and corresponds to 1% of total costs. Research and development costs of EUR 21.0 million increased compared to the same period last year (EUR 15.7 million). This increase is due to the planned significantly higher costs for the Phase I/IIa study with HDP-101. R&D costs continue to represent the largest cost item, accounting for 74% of operating expenses. Administrative costs, which include the costs of holding activities, the stock exchange listing and the executive management board, increased to EUR 5.0 million compared to the same period last year (EUR 4.7 million), which is mainly due to higher personnel costs. Administrative costs account for 18% of operating expenses. Other expenses for business development, marketing and commercial market supply activities, which mainly include personnel and travel expenses, but also expenses for exchange rate differences (EUR 1.1 million), doubled compared to the previous year from EUR 1.0 million to EUR 2.0 million and represented 7% of operating expenses.

The financial result, which is mainly made up of interest income on bank balances, amounted to EUR 0.7 million (previous year: EUR 1.0 million). Despite the full repayment of the shareholder loan last year, the decrease is attributable to a lower investment volume and lower interest rates.

The net loss for the first nine months of the financial year increased to EUR 21.1 million compared to the previous year’s figure of EUR 14.3 million. The increase is mainly due to higher operations expenses. Earnings per share deteriorated accordingly from EUR -0.31 in the previous year to EUR -0.45 in the reporting period.

Cash amounted to EUR 22.9 million at the end of the third quarter (30 November 2024: EUR 29.4 million; 31 August 2024: EUR 36.6 million). Excluding financing effects (shareholder loans, sale of receivables), Heidelberg Pharma recorded an average cash outflow of EUR 2.8 million per month in the first nine months of the fiscal year (previous year: EUR 2.6 million).

Total assets as of 31 August 2025 amounted to EUR 54.1 million and were therefore below the figure at the comparative reporting date of 30 November 2024 (EUR 60.7 million). Equity (EUR 10.5 million) also decreased as a result of the loss for the period compared to the end of the 2024 financial year (EUR 30.9 million).

Financial outlook for 2025

The guidance issued on 21 March 2025 for the current financial year was adjusted on 6 October 2025.

The Heidelberg Pharma Group expects sales and other income for the financial year 2025 between EUR 7.5 million and EUR 9 million (previously: EUR 9 million to EUR 11 million). Operating expenses are expected to range between EUR 36 million and EUR 40 million (previously: EUR 40 million to EUR 45 million).

Based on these adjustments, an operating result (EBIT) between EUR -28.5 million and EUR -31 million is expected (previously: EUR -30 million to EUR -35 million).

As part of the strategic focus, long-term and short-term assets are still being reviewed for impairment. They could prove to be only partially or no longer recoverable, resulting in value adjustments. Such non-cash depreciation on assets would lead to additional operating expenses in the current fiscal year, which in turn could have a negative impact on the operating result beyond the aforementioned range of between EUR -28.5 million and EUR -31 million.

For 2025, Heidelberg Pharma anticipates cash requirements of EUR 14 million to EUR 17 million (previously: EUR 50 million to EUR 55 million anticipated inflow). Monthly cash outflow is expected to range between EUR 1.2 million and EUR 1.5 million per month (previously: EUR 4.2 million and EUR 4.6 million inflow). Based on current planning and available funds, the Company’s financing is secured until mid-2026.

The Executive Management Board, in accordance with the Supervisory Board, is in talks with the main shareholders and other parties to secure financing in the medium term.

The complete set of figures for the interim financial statements is available at http://www.heidelberg-pharma.com/ “Press & Investors > Announcements and Reports > Financial Reports > Interim announcement of 9 October 2025. A conference call on this interim announcement will not be offered.

Key figures for the Heidelberg Pharma Group

In EUR thsd. 9M 2025 1
EUR thsd.
9M 2024 1
EUR thsd.
Earnings    
Sales revenue 1,436 5,248
Other income 4,988 2,368
Operating expenses (28,179) (22,849)
of which research and development costs (21,042) (15,650)
Operating result (21,756) (15,233)
Earnings before tax (21,054) (14,259)
Net loss for the period / Comprehensive income (21,054) (14,259)
Basic earnings per share in EUR (0.45) (0.31)
     
Balance sheet as of the end of the period    
Total assets 54,052 65,775
Cash 22,869 36,569
Equity 10,530 35,823
Equity ratio2 in % 19.5 54.5
     
Cash flow statement    
Cash flow from operating activities (24,818) (22,749)
Cash flow from investing activities (179) (266)
Cash flow from financing activities 18,428 16,106
     
Employees (number)    
Employees as of the end of the period3 126 109
Full-time equivalents as of the end of the period3 114 98

1 The reporting period begins on 1 December and ends on 31 August.
2 Equity / total assets
3 Including members of the Executive Management Board
Rounding of exact figures may result in differences.

Contact
Heidelberg Pharma AG
Sylvia Wimmer
Director Corporate Communications
Tel.: +49 89 41 31 38 29
Email: investors@hdpharma.com
Gregor-Mendel-Str. 22, 68526 Ladenburg
 
IR/PR support
MC Services AG
Katja Arnold (CIRO)
Managing Director & Partner
Tel.: +49 89 210 228 40
Email: katja.arnold@mc-services.eu
 

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology.

The lead candidate HDP-101 is a BCMA ATAC in clinical development for multiple myeloma. A second ATAC candidate, HDP-102, has recently started clinical development in Non-Hodgkin Lymphoma and is currently on a temporary hold. HDP-103 against metastatic castration-resistant prostate cancer and HDP-104 targeting gastrointestinal tumors such as colorectal cancer have completed preclinical development. Heidelberg Pharma is open for partnering.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com

ATAC® is a registered trademark of Heidelberg Pharma Research GmbH.

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will”, “should”, “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.


09.10.2025 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.
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Language: English
Company: Heidelberg Pharma AG
Gregor-Mendel-Str. 22
68526 Ladenburg
Germany
Phone: +49 (0)89 41 31 38 – 0
Fax: +49 (0)89 41 31 38 – 99
E-mail: investors@hdpharma.com
Internet: www.heidelberg-pharma.com
ISIN: DE000A11QVV0
WKN: A11QVV
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2210160

 
End of News EQS News Service

2210160  09.10.2025 CET/CEST

Gerresheimer: Business performance and slower market growth require guidance adjustment

Gerresheimer AG

/ Key word(s): Profit Warning/Quarter Results

Gerresheimer: Business performance and slower market growth require guidance adjustment

08.10.2025 / 23:58 CET/CEST

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


Gerresheimer: Business performance and slower market growth require guidance adjustment

  • Preliminary results for 9M 2025: Revenues +14.6%, Adjusted EBITDA +7.2% 
  • Organic development: Revenues -1.8%, Adjusted EBITDA -7.5%
  • Subdued demand in the cosmetics and oral liquids segment continues
  • Separation of Moulded Glass progressing according to plan; independent division within new segmentation from 2026
  • Updated guidance for 2025: Organic revenue decline of -2% to -4%, adjusted EBITDA margin around 18.5 to 19%
  • Transformation program initiated to increase performance and reduce costs

Duesseldorf, October 8, 2025. Gerresheimer, an innovative system and solution provider and global partner for the pharma, biotech, and cosmetics industries, is adjusting its guidance for the 2025 financial year in light of the preliminary results for the third quarter of 2025 and slower-than-expected market growth. According to preliminary figures, revenues in the third quarter of 2025 declined organically by -1.2% compared to the same period last year, with an organic adjusted EBITDA margin of 18.8%. According to preliminary results, Gerresheimer generated positive free cash flow of EUR 21 million in the third quarter of 2025. Revenue growth and the adjusted EBITDA margin for the first nine months of the 2025 financial year are lower than expected overall. Although the company expects the fourth quarter to be stronger than the third quarter due to production ramp-ups for drug delivery systems, revenues for the full year 2025 are now expected to decline organically between -4% and -2% (previously organic revenue growth 0 to 2%), and the adjusted EBITDA margin is expected to be around 18.5% to 19% (previously around 20%). In the first nine months of the 2025 financial year, preliminary figures show that revenues rose by 14.6% to EUR 1,681.4 million (9M 2024: EUR 1,467.0 million), while adjusted EBITDA rose by 7.2% to EUR 313.9 million (9M 2024: EUR 292.7 million). Organic development compared with the pro forma figures for the same period last year continued to show significant market influences, including subdued demand in the cosmetics market and in the area of containment solutions for oral liquids. According to preliminary results, organic revenues declined by 1.8% in the first nine months, while adjusted EBITDA fell by 7.5%. The organic adjusted EBITDA margin was 18.8% (9M 2024: 19.9%). In view of slower market growth and business development in 2025, Gerresheimer has initiated a transformation program to reduce costs and improve performance. 

“The operative performance of our business in the first nine months is clearly below our expectations,” said Dietmar Siemssen, CEO of Gerresheimer AG. “Our goal is to grow faster than the overall market again in the medium and long term. The expansion of our product portfolio to include systems and solutions for biologics and the implementation of our growth projects will contribute considerably to this.”

Plastics & Devices: High demand for drug delivery systems

According to preliminary figures, the Plastics & Devices division generated revenues of EUR 972.6 million in the first nine months of the 2025 financial year (9M 2024: EUR 820.1 million). In absolute terms, revenues rose by 18.6% mainly due to the inclusion of Bormioli Pharma. Organic revenues also grew by 2.6% compared to the pro forma figures for the same period of the previous year. Strong demand for drug delivery systems compensated for the market weakness in plastic containment solutions for oral liquids.

Adjusted EBITDA grew by 6.8% to EUR 222.6 million (9M 2024: EUR 208.5 million). In organic terms, adjusted EBITDA was 6.6% below the pro forma figures for the same period of the previous year. The organic adjusted EBITDA margin of 22.9% (9M 2024: 25.2%) reflects lower capacity utilization at Oral Liquids and start-up costs for the ramp-up of new production lines for drug delivery systems.

Primary Packaging Glass: Subdued demand for cosmetics and oral liquids continues

According to preliminary figures, the Primary Packaging Glass division generated revenues of EUR 714.4 million in the first nine months of the 2025 financial year (9M 2024: EUR 648.0 million). In absolute terms, revenues rose by 10.3% due to the inclusion of Bormioli Pharma. Organically, revenues declined by 6.9% compared with the pro forma figures for the same period of the previous year. The organic decline in revenues was due, among other things, to continued subdued demand in the cosmetics business and in the oral liquid business in the pharmaceuticals sector. Demand for our Gx RTF vials developed positively.

Adjusted EBITDA rose by 6.2% to EUR 127.2 million (9M 2024: EUR 119.7 million). In organic terms, adjusted EBITDA was 7.2% below the pro forma figures for the same period of the previous year. The decline in adjusted EBITDA is primarily attributable to a decrease in demand in the Moulded Glass business segment. The organic adjusted EBITDA margin remained unchanged at 18.0% (9M 2024: 18.0%).

Stronger Q4 expected compared to Q3 2025, 2025 guidance adjusted

Gerresheimer expects a stronger fourth quarter 2025 compared to the third quarter 2025, mainly due to planned production ramp-ups for drug delivery systems. However, organic growth in the fourth quarter will not be able to fully compensate for the business performance of the first nine months of 2025. Based on the business performance to date and slower market growth, the company is therefore adjusting its guidance for the 2025 financial year. Revenues are expected to decline organically by between -4% and -2% (previously organic revenues growth of 0-2%), and the adjusted EBITDA margin is expected to be around 18.5 to 19% (previously around 20%). 

Separation of Moulded Glass is progressing – separate division from 2026

As part of the integration of Bormioli Pharma into the Gerresheimer Group, Gerresheimer has already begun to establish the combined Moulded Glass business as a global, independent unit. Hans-Norbert Topp, an internationally experienced manager with a proven track record, has been appointed to head the business unit. In August 2025, Gerresheimer announced its intention to separate the Moulded Glass business and subsequently initiate a sales process in order to position itself in the future as a system and solution provider purely for the pharma and biotech industries. The separation process is progressing according to plan. From the 2026 financial year, the Moulded Glass business will be managed as a separate division as part of a new segmentation. The sale process is being prepared for 2026.

Transformation program launched

Against the backdrop of slower market growth and adjusted guidance for the 2025 financial year, Gerresheimer has already initiated measures to reduce costs, increase performance, and improve free cash flow. The comprehensive transformation program that Gerresheimer will now implement includes even more selective investment planning with a clear focus on free cash flow, measures to increase operational and sales excellence, and optimization of the global production network. A newly created Transformation Office reporting directly to the CFO will drive the program forward.

The quarterly report for the third quarter of 2025 with the final results will be published on October 10 on the Gerresheimer website here:
 

https://www.gerresheimer.com/en/investors/archive

 

About Gerresheimer 
Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The Group offers a comprehensive portfolio of drug containment solutions including closures and accessories, as well as drug delivery systems, medical devices and solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, cartridges, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. Gerresheimer supports its customers with comprehensive services along the value chain and in addressing the growing demand for enhanced sustainability. With over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. Together with Bormioli Pharma, the Group generated revenues of around EUR 2.4bn in 2024 and currently employs around 13,600 people. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).    
www.gerresheimer.com

 

Contact Gerresheimer AG

Media  
Jutta Lorberg
Head of Corporate Communication
T +49 211 6181 264
jutta.lorberg@gerresheimer.com                       
Marion Stolzenwald
Senior Manager Corporate Communication
T +49 172 2424185
marion.stolzenwald@gerresheimer.com
 
Investor Relations
 
Guido Pickert
Vice President Investor Relations
T +49 211 6181 220
gerresheimer.ir@gerresheimer.com
 
Thomas Rosenke
Senior Manager Investor Relations
T +49 211 6181-187
gerresheimer.ir@gerresheimer.com


08.10.2025 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.
Archive at www.eqs-news.com


Language: English
Company: Gerresheimer AG
Peter-Müller-Str. 3
40468 Duesseldorf
Germany
Phone: +49-(0)211/61 81-00
Fax: +49-(0)211/61 81-121
E-mail: gerresheimer.ir@gerresheimer.com
Internet: http://www.gerresheimer.com
ISIN: DE000A0LD6E6
WKN: A0LD6E
Indices: MDAX (Aktie)
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2210278

 
End of News EQS News Service

2210278  08.10.2025 CET/CEST