Xlife Sciences AG Publishes 2024 ESG Report: Sustainable Value Creation as a Strategic Core

Compared to the previous year, Xlife Sciences recorded significant improvements in its sustainability performance: both water consumption and indirect emissions were substantially reduced. At the same time, ESG considerations were further integrated into investment decisions and portfolio management, employee training was expanded, and collaboration with Generation Impact Global as a GRI partner was continued to further enhance transparency and international comparability.

This year’s edition of the report also highlights the ongoing development of ESG structures and processes, measurable progress in energy efficiency, resource conservation, and emissions reduction, as well as the promotion of diversity, equality, and continuous education across all levels.

«We invest in innovations that improve people’s lives while taking responsibility for their ecological and social impact. The 2024 ESG Report underscores our commitment to embedding sustainable value creation in the life sciences sector over the long term», said Désirée A. Dosch, Member of the Board of Directors, Xlife Sciences AG.

The report was prepared in accordance with the Global Reporting Initiative (GRI) standards, which provide internationally recognized guidelines for transparent and comparable sustainability reporting. As part of its commitment to responsible action, Xlife Sciences is supporting the Cleaner, Safer Water in Cambodia Initiative in 2024 – a Gold Standard-certified climate protection program that provides rural communities with access to clean drinking water through ceramic filters. The project reduces CO₂ emissions by around 90.000 tons per year, protects forests, strengthens local businesses, and improves the living conditions of nearly two million people – an example of how Xlife Sciences combines environmental responsibility with social impact.

The full 2024 ESG Report is available for download at https://www.xlifesciences.ch/en/esg-en

 

Financial calendar

Annual Report 2025 28 April 2026
Annual Shareholders Meeting 2026 26 June 2026
Half-Year Report 2026 24 September 2026

DocMorris accelerates sequential Rx growth and increases non-Rx revenue

DocMorris AG

/ Key word(s): 9 Month figures

DocMorris accelerates sequential Rx growth and increases non-Rx revenue

16.10.2025 / 07:00 CET/CEST


Frauenfeld, 16 October 2025

Press release

DocMorris accelerates sequential Rx growth and increases non-Rx revenue

  • Total revenue rises by 9.5 per cent in the first nine months
  • Sequential Rx quarterly growth accelerates to 9.2 per cent in Q3
  • Non-Rx business in Germany grows in all areas; TeleClinic up over 140 per cent
  • Full roll-out of AI-based DocMorris health companion
  • Andrea Skersies appointed CCO and member of the Executive Board

CEO Walter Hess says: “Our continuous growth shows that we are on the right track with marketing efficiency in our core business and the scaling of innovative services. With the new AI-based DocMorris Health Companion, we are using artificial intelligence for millions of customers and patients and making it a tangible experience. We are also strengthening our position as Europe’s trusted health brand. David Masó becomes new Chief AI Health Officer, and with Chief Commercial Officer Andrea Skersies, we are expanding the Group Executive Board with an experienced e-commerce expert.”

CFO Daniel Wüest adds: “DocMorris has made an encouraging start to what is traditionally its strongest fourth quarter. The figures for the first nine months confirm our growth trajectory: we have significantly increased both revenue and our customer base and are on track to achieve our 2025 outlook. In the third quarter, the focus was on sustainable, profitable and future sales growth while improving profitability through efficiency gains and cost reductions. This will enable us to lay the foundation for achieving our EBITDA breakeven target in the course of 2026.”

Significant revenue growth in the first nine months

  • DocMorris increased its external revenue[1] by 9.5 per cent[2] to CHF 854.3 million in the first nine months 2025, despite the discontinuation of the Zur Rose brand in Germany at the end of 2024.
  • In the third quarter, sales increased by 8.1 per cent to CHF 282.3 million, despite the usual seasonal slowdown due to the summer holidays.
  • The Germany segment grew by 10.0 per cent in the first nine months, while revenue in the Europe segment increased by 2.7 per cent with a focus on profitability.
  • The number of active customers[3] increased from 10.3 million to 10.6 million in the first nine months and from 10.5 million to 10.6 million in the third quarter.

Sequential Rx growth continues to accelerate

  • External Rx revenue rose significantly by 37.9 per cent in the first nine months.
  • Sequential Rx growth continued to accelerate: from the second to the third quarter, Rx revenue increased by 9.2 per cent.

Revenue increase across all non-Rx areas

  • Non-Rx external revenue[4] increased by 4.3 per cent in the first nine months and also grew across all areas from the second to the third quarter.
  • TeleClinic increased its revenue by more than 140 per cent to over CHF 17 million in the first nine months and is increasingly becoming an important part of the German business.
  • TIME Magazine named TeleClinic one of the “World’s Top HealthTech Companies 2025”.
  • Retail media and the marketplace achieved high double-digit growth.
  • All service platforms are making a disproportionately large contribution to profitability.

DocMorris health companion available to all app users

  • The AI-based DocMorris health companion has been available to all users of the DocMorris app since the beginning of October with the full rollout of the beta phase of the DocMorris Assistant.
  • DocMorris is also strengthening the strategic importance of the AI-based health companion in organisational terms and consolidates the associated activities relating to the digital health ecosystem under Executive Board member David Masó as the new Chief AI Health Officer (CAHO).

Streamlining management structures and using AI to increase efficiency

  • DocMorris is bundling all e-commerce activities in the Germany and Europe segments under Andrea Skersies as the new Chief Commercial Officer (CCO) and member of the Executive Board, while at the same time reducing one management level. Andrea Skersies has many years of management experience in online retail, including 13 years as Chief Marketing Officer (CMO) and member of the Executive Board at Zooplus and as CMO of an online pharmacy.
  • As part of this realignment, further management structures will be adjusted and the organisation streamlined in a targeted manner.
  • DocMorris is also reducing costs through the increased use of AI automation.

Outlook

  • Management confirms the revenue and earnings guidance for 2025 communicated on 10 April, as well as EBITDA breakeven in the course of 2026 and free cash flow breakeven in the course of 2027. The other medium-term targets remain unchanged.

 

Revenue, in CHF million (unaudited) 1.1.-30.9.2025 1.1.-30.9.2024 Change
DocMorris external revenue 854.3 795.8 7.4%
DocMorris external revenue in local currency     9.5%
DocMorris 809.4 744.7 8.7%
DocMorris in local currency     10.9%
       
Markets      
Germany external revenue 806.2 748.0 7.8%
Germany external revenue in local currency     10.0%
Germany external revenue Rx 170.5 126.2 35.1%
Germany external revenue Rx in local currency     37.9%
Germany external revenue non-Rx 635.7 621.8 2.2%
Germany external revenue non-Rx in local currency     4.3.%
Germany 761.3 696.9 9.2%
Germany in local currency     11.4%
Europe 48.1 47.7 0.7%
Europe in local currency     2.7%

 

Revenue, in CHF million (unaudited) 1.7.-30.9.2025 1.7.-30.9.2024 Change
DocMorris external revenue 282.3 265.7 6.3%
DocMorris external revenue in local currency     8.1%
DocMorris 268.1 248.4 8.0%
DocMorris in local currency     9.8%
       
Markets      
Germany external revenue 267.6 250.2 6.9%
Germany external revenue in local currency     8.8%
Germany external revenue Rx 60.9 48.1 26.4%
Germany external revenue Rx in local currency     28.8%
Germany external revenue non-Rx 206.8 202.1 2.3%
Germany external revenue non-Rx in local currency     4.1%
Germany 253.5 233.0 8.8%
Germany in local currency     10.7%
Europe 14.6 15.4 -5.0%
Europe in local currency     -3.4%

 

Investors and analyst contact
Dr. Daniel Grigat, Head of Investor Relations & Sustainability
Email: ir@docmorris.com, phone: +41 52 560 58 10

Media contact
Torben Bonnke, Director Communications
Email: media@docmorris.com, phone: +49 171 864 888 1

 

Agenda

20 January 2026 Sales 2025
19 March 2026 2025 Full-year results and outlook 2026 (conference call/webcast)
16 April 2026 Q1/2026 Trading update
12 May 2026 Annual General Meeting, Zurich
19 August 2026 2026 Half-year results (conference call/webcast)
15 October 2026 Q3/2026 Trading update

 

DocMorris
The Swiss-based DocMorris AG is a leading company in the fields of online pharmacy, telemedicine and marketplace with strong brands in Germany and other European countries. Deliveries are mainly from the highly automated logistics centre in Heerlen, the Netherlands. TeleClinic is Germany’s largest telemedicine platform, connecting patients with more than 5,000 physicians. DocMorris operates leading marketplaces for health and personal care products in Southern Europe. With its broad range of products and services, DocMorris is pursuing its vision of becoming the leading digital health companion for everyone to manage their health in one click. Around 1,600 employees in Germany, the Netherlands, Spain, France, Portugal and Switzerland generated an external revenue of CHF 1,085 million serving more than10 million active customers in 2024. The shares of DocMorris AG are listed on the SIX Swiss Exchange (securities number 4261528, ISIN CH0042615283, ticker DOCM). For further information, please visit corporate.docmorris.com.

 

Disclaimer
This communication expressly or implicitly contains certain forward-looking statements concerning DocMorris AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of DocMorris AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. DocMorris AG 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.

 

[1] External revenue consists of the consolidated revenue of DocMorris plus online revenues of pharmacies supplied by DocMorris, less the consolidated revenue from supplying them.

[2] All percentages are in local currency.

[3] Customers supplied by DocMorris, either directly or through its partners.

[4] Consisting of OTC business and services (TeleClinic, marketplace, retail media)


End of Media Release


Language: English
Company: DocMorris AG
Walzmühlestrasse 49
8500 Frauenfeld
Switzerland
ISIN: CH0042615283
Listed: SIX Swiss Exchange
EQS News ID: 2213728

 
End of News EQS News Service

2213728  16.10.2025 CET/CEST

Sartorius Stedim Biotech publishes unaudited results for the first nine months of 2025

Sartorius Stedim Biotech SA

/ Key word(s): 9 Month figures

Sartorius Stedim Biotech publishes unaudited results for the first nine months of 2025

16-Oct-2025 / 07:00 CET/CEST


Aubagne, France | October 16, 2025

Sartorius Stedim Biotech publishes unaudited results for the first nine months of 2025

  • Sales revenue reaches 2,195 million euros, up by a double-digit 10.2 percent in constant currencies (reported: 8.2 percent)
  • High-margin consumables business records continued significant growth
  • Underlying EBITDA1 increases by 21.0 percent to 683 million euros, outpacing sales revenue growth; underlying EBITDA margin climbs to 31.1 percent
  • Management sharpens full-year guidance at upper end of forecast range             

Sartorius Stedim Biotech, a leading partner to the biopharmaceutical industry, maintained its dynamic growth path with significant increases in sales revenue and profitability in the first three quarters of the fiscal year.

“Sartorius Stedim Biotech delivered a strong performance in the first nine months of the year, driven by substantial, double-digit growth in our consumables business. While customers are still hesitant to invest, we do see our bioprocessing equipment business stabilizing. In light of these positive developments, we are very confident about the remainder of the year and have sharpened our 2025 forecast at the upper end of the previously defined range,” said Dr. René Fáber, CEO of Sartorius Stedim Biotech. “Our biopharma customers are under increasing pressure to accelerate timelines and cut costs for innovative therapies – while patients await breakthrough treatments. We support them with a portfolio designed to simplify processes, intensify production, and scale up with confidence.”

Business development1
In the first nine months of fiscal 2025, Sartorius Stedim Biotech recorded a significant increase in sales revenue of 10.2 percent in constant currencies, reaching 2,195 million euros. The reported growth rate stood at 8.2 percent, mainly due to the depreciation of the US dollar. The development was driven by the high-margin business with consumables for the manufacture of biopharmaceuticals, which continued its strong growth trend. While remaining soft due to the industry-wide reluctance of customers to invest, business with bioprocess equipment and systems is stabilizing. All regions contributed to the positive development: Sales revenue in the Americas and Asia/Pacific regions saw double-digit growth, up 11.8 percent and 11.2 percent respectively in constant currencies. In the EMEA region, where business recovery had already begun earlier, sales revenue rose by 8.4 percent.

Underlying EBITDA grew even more strongly than sales revenue, increasing by 21.0 percent to 683 million euros, mainly due to volume, product mix, and scale effects. The corresponding margin grew strongly by 3.3 percentage points to 31.1 percent (PY: 27.8 percent).

Underlying net profit was up significantly by 34.3 percent and reached 320 million euros (PY: 238 million euros), while net profit after non-controlling interest surged by 68.5 percent to 218 million euros (PY: 129 million euros). Underlying earnings per share climbed to 3.28 euros (PY: 2.46 euros), and earnings per share to 2.24 euros (PY: 1.34 euros).

As of September 30, 2025, Sartorius Stedim Biotech employed 10,134 people – an increase of 233 employees compared to the end of 2024, mainly due to the hiring of additional production personnel.

Between January and September, the company expanded its product portfolio to further enhance productivity in drug manufacturing, including new offerings for process intensification. Additionally, in the third quarter, Sartorius Stedim Biotech introduced an enhanced filtration solution for monoclonal antibodies, which enables shorter processes and reduces water consumption, as well as new software solutions for bioprocesses. The company also entered into a collaboration with the US start-up Nanotein Technologies to advance the commercialization and development of innovative reagents that promote cell activation and expansion in cell therapy manufacturing.

Key financial indicators
Sartorius Stedim Biotech’s balance sheet and key financial figures remain at very robust levels. Equity amounted to 4,072 million euros as of September 30, 2025, with an equity ratio1 of 51.7 percent (December 31, 2024: 4,024 million euros and 48.7 percent, respectively).

Investments in the company’s global research and production infrastructure amounted to 276 million euros compared with 260 million euros in the prior-year period. The ratio of capital expenditures to sales revenue increased over the year, as planned, reaching 12.6 percent by the end of September (PY 12.8 percent).

Gross debt totaled 2,563 million euros, net debt 2,264 million euros (December 31, 2024: 2,869 million euros and 2,191 million euros, respectively). As planned, the ratio of net debt to underlying EBITDA1 was reduced further and stood at 2.5 (December 31, 2024: 2.8).

Guidance for fiscal 2025 specified 
Based on the year-to-date results and taking into account the anticipated impact of existing tariffs as well as the strong basis for comparison of the fourth quarter of 2024, management further sharpens its full-year guidance at the upper end of the forecast range. The company now expects sales revenue growth of around 9 percent (previously: 7 percent with a forecast range of around plus/minus two percentage points). In terms of profitability, management anticipates an underlying EBITDA margin of around 31 percent (previously: around 30 to 31 percent).
 
The forecast for the ratio of capital expenditures to sales revenue remains unchanged at around 13 percent, and the ratio of net debt to underlying EBITDA1 is still expected to be at around 2.5.

1 Sartorius Stedim Biotech publishes alternative performance measures that are not defined by international accounting standards. These are determined with the aim of improving the comparability of business performance over time and within the industry.  

  • Constant currencies: figures given in constant currencies eliminate the impact of changes in exchange rates by applying the same exchange rate for the current and the previous period. 
  • Organic: organic growth figures exclude the impact from changes in exchange rates and changes in the scope of consolidation. 
  • Underlying EBITDA: earnings before interest, taxes, depreciation, and amortization and adjusted for extraordinary items  
  • Underlying net profit: profit for the period after non-controlling interest, adjusted for extraordinary items and amortization, as well as based on the normalized financial result and the normalized tax rate
  • Underlying earnings per share: underlying net profit in relation to the weighted-average number of shares outstanding
  • Equity ratio: equity in relation to the balance sheet total 
  • Ratio of net debt to underlying EBITDA: quotient of net debt and underlying EBITDA over the past 12 months, including the pro forma amount contributed by acquisitions for this period 

2 EMEA = Europe, Middle East, Africa 
 
This media release contains forward-looking statements about the future development of the Sartorius Stedim Biotech Group. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied by such statements. Sartorius Stedim Biotech assumes no liability for updating such statements in light of new information or future events. Sartorius Stedim Biotech shall not assume any liability for the correctness of this release. The original French media release is the legally binding version. 
 
Forecasts have been prepared based on historical information and are consistent with accounting policies. All forecast figures are based on constant currencies, as in past years. Management points out that the dynamics and volatilities in the industry have increased significantly in recent years. In addition, uncertainties due to the changed geopolitical situation, such as the emerging decoupling tendencies of various countries as well as the trade policy framework conditions, are playing a greater role. This results in higher uncertainty when forecasting business figures. 

Conference Call  
Dr. René Fáber, CEO of the Sartorius Stedim Biotech Group, will discuss the company’s 9M results with analysts and investors in a conference call at 1.00 p.m. CEST on October 16, 2025.  
Register here: https://sar.to/9M_2025_IR_Conference

 
 
Key Performance Indicators for the first nine months of 2025
 

in millions of € unless otherwise specified 9 mon. 2025 9 mon. 2024 Δ in % Δ in % cc1
Sales revenue 2,195.3 2,028.7 8.2 10.2
  • EMEA2
921.3 850.5 8.3 8.4
  • Americas2
781.9 718.6 8.8 11.8
  • Asia | Pacific2
492.1 459.6 7.1 11.2
Results        
Underlying EBITDA3 683.1 564.7 21.0  
Underlying EBITDA margin3 in % 31.1 27.8    
Underlying net profit4 319.5 238.0 34.3  
Underlying earnings per share4 in € 3.28 2.46 33.3  
Net profit5 218.3 129.5 68.5  
Earnings per share5 in € 2.24 1.34 67.3  
Cashflow        
Cash flow from operating activities 445.7 530.2 -15.9  
Free cash flow6 166.8 270.4 -38,3  
         

1 cc = constant currency: Figures given in constant currencies eliminate the impact of changes in exchange rates by applying the
same exchange rate for the current and the previous period
2 According to customer location
3 Underlying EBITDA = earnings before interest, taxes, depreciation and amortization, and adjusted for extraordinary items
4 Relevant / underlying net profit = net profit after non-controlling interest; adjusted for extraordinary items and 
amortization, and based on a normalized financial result and normalized tax rate
5 After non-controlling interest
6 Cash flow from operating activities minus cash flow from investing activities

Figures are not audited or reviewed


Reconciliation of alternative performance measures
 

Reconciliation between EBIT and underlying EBITDA    
In millions of € 9 mon. 2025 9 mon. 2024
EBIT (operating result) 405.0 285.6
Extraordinary Items 43.9 57.9
Depreciation & amortization 234.2 221.1
Underlying EBITDA 683.1 564.7
     

Reconciliation between EBIT and underlying net result

In millions of € 9 mon. 2025 9 mon. 2024
EBIT (operational result) 405.0 285.6
Extraordinary Items 43.9 57.9
Amortization | IFRS 3 85.3 87.7
Normalized financial result1 –101.8 –106.1
Normalized income tax (26%)2 –112.4 –84.6
Underlying net result 319.9 240.7
Non-controlling interest –0.4 –2.7
Underlying net result excluding non-controlling interest 319.5 238.0
Underlying earnings per share in € 3.28 2.46
     

1 Financial result excluding fair value adjustments of hedging instruments and currency effects relating to financing activities
2 Underlying income tax, based on the underlying profit before taxes and amortization
Figures are not audited or reviewed
 

Ratio of net debt to underlying EBITDA    
in millions of €unless otherwise specified Sept. 30, 20251 Dec. 31, 2024
Gross debt 2,563.1 2,869.5
– Cash and Cash equivalents 298.7 678.9
Net debt 2,264.4 2,190.6
     
Underlying EBITDA (12 months) 897.3 779.0
Ratio of net debt to underlying EBITDA 2.5 2.8
     

1 Figures are not audited or reviewed
 

Capital expenditures    
in millions of € unless otherwise specified 9 mon. 2025 9 mon. 2024
Sales revenue 2,195.3 2,028.7
Capital expenditures 276.1 259.8
Capital expenditures as % of sales revenue 12.6 12.8
     

Figures are not audited or reviewed


A Profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international partner to the biopharmaceutical industry. As a provider of innovative solutions, the company based in Aubagne, France, helps its customers to manufacture biotech medications, such as cell and gene therapies, more safely, rapidly, and sustainably. The shares of Sartorius Stedim Biotech S.A. are listed on the Euronext Paris. The company has a strong global reach with manufacturing and R&D sites as well as sales entities in Europe, North America, and Asia. Sartorius Stedim Biotech regularly expands its portfolio through acquisitions of complementary technologies. In 2024, the company generated sales revenue of around 2.8 billion euros. More than 9,900 employees work for customers around the globe.

Visit our Newsroom or follow us on LinkedIn.

Contact
Leona Malorny
Head of External Communications
+49 551 308 4067
leona.malorny@sartorius.com
 


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2213762  16-Oct-2025 CET/CEST

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.
Archive at www.eqs-news.com


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

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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.
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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


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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!


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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.

 


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