EMA Grants PRIME Status to Pentixapharm’s Lead Candidate PentixaFor

Pentixapharm Holding AG / Key word(s): Study

EMA Grants PRIME Status to Pentixapharm’s Lead Candidate PentixaFor

18-Oct-2024 / 15:49 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 AG.

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


Würzburg and Berlin, Germany, October 18, 2024 – The European Medicine Agency (EMA) has granted PRIME Status to Pentixapharm’s lead candidate Ga68-PentixaFor, thereby granting an early and proactive support for the development of the radiodiagnostic and the possibility of an accelerated approval. The benefits of PRIME status include an early appointment of CHMP or CAT rapporteurs, iterative scientific advice on development plans, introductory meeting on regulatory requirements, and potentially a total fee exemption for scientific advice. The status also confirms that PentixaFor has the potential to address, in primary aldosteronism (PA), an unmet medical need to a significant extent.

PentixaFor is a novel tracer for positron emission tomography (PET) imaging targeting the C-X-C receptor 4 (CXCR4). High expression of CXCR4 has been identified in aldosterone-producing tissue, which is responsible for the aldosterone over-secretion that causes PA. PentixaFor aims to be a non-invasive and accurate alternative to adrenal venous sampling (AVS), the current invasive and difficult Standard of Care procedure, offering the potential to transform diagnostic subtyping in PA.

PRIME is a status granted by the EMA for promising medicines that target an unmet medical need with the goal of optimizing these medicines’ development. The PRIME scheme is based on enhanced interaction and dialogue between EMA and Sponsor, to improve the development plans and speed up the evaluation, so that the medicines can earlier reach the patients. In particular, the PRIME scheme allows iterative scientific advice on the overall development plans and key issues, expedited follow-up scientific advice with shortened timelines, and potential accelerated assessment at the time of application for a marketing authorization. Since the start of the program in 2016, only 139 applications were granted, with Ga68-CXCR4 being the first radiopharmaceutical.

Primary aldosteronism, also known as Conn’s syndrome, is an adrenal gland disorder and the most common cause of secondary hypertension. However, it remains difficult to diagnose and to effectively treat with current methods. Pentixapharm is currently preparing a Phase III pivotal study to obtain marketing authorization in PA that will start in 2025.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
phillip.eckert@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

End of Inside Information


Information and Explanation of the Issuer to this announcement:

About Pentixapharm

Pentixapharm is a clinical-stage radiopharmaceutical development company with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceuticals for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a Phase III registration study with PentixaFor in PA that will start in Europe and in the United States in 2025.


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STRATEC POSTS PRELIMINARY RESULTS FOR FIRST NINE MONTHS OF 2024: TARGET CORRIDOR FOR ADJUSTED EBIT MARGIN CONFIRMED WITH ADJUSTMENT TO 2024 SALES GUIDANCE

STRATEC SE / Key word(s): Preliminary Results/Change in Forecast

STRATEC POSTS PRELIMINARY RESULTS FOR FIRST NINE MONTHS OF 2024: TARGET CORRIDOR FOR ADJUSTED EBIT MARGIN CONFIRMED WITH ADJUSTMENT TO 2024 SALES GUIDANCE

17-Oct-2024 / 19:43 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 AG.

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


STRATEC POSTS PRELIMINARY RESULTS FOR FIRST NINE MONTHS OF 2024; TARGET CORRIDOR FOR ADJUSTED EBIT MARGIN CONFIRMED WITH ADJUSTMENT TO 2024 SALES GUIDANCE

Birkenfeld, October 17, 2024

Based on preliminary figures, STRATEC generated consolidated sales of € 176.3 million in the first nine months of 2024 (9M/2023: € 187.7 million). Its sales performance in the third quarter of 2024 therefore fell short of expectations. This is mainly due to deliveries being postponed to the fourth quarter of 2024 and the 2025 financial year respectively. Despite negative scale effects and the product mix still not being optimal, STRATEC managed to achieve a level of profitability consistent with the targeted pathway needed to meet its full-year margin guidance for 2024. Based on preliminary calculations, the adjusted EBIT margin for the first nine months of 2024 will amount to 8.4% and thus almost match the previous year’s level (adjusted EBIT margin 9M/2023: 8.6%). In this respect, the margin has benefited in particular from the earnings enhancement measures initiated eighteen months ago and since continually extended, as well as from the associated early steps to adjust capacities in line with the current market situation.

Furthermore, STRATEC is shortly due to sign further additional orders with customers, most of which were not included in the original financial guidance for 2024. As a result, sales and earnings are expected to improve significantly in the fourth quarter of 2024 compared with the first nine months of 2024. STRATEC accordingly expects to be able to make up for most of the shortfall in sales by the end of the year. Given the ongoing volatility in the market climate, STRATEC’s Board of Management has therefore decided to slightly adjust its sales guidance for 2024. STRATEC now expects its constant-currency sales to remain stable or decline slightly compared with the previous year (previously: constant-currency sales to remain stable or rise slightly). By contrast, the 2024 guidance for the adjusted EBIT margin has been confirmed at around 10.0% to 12.0%.

STRATEC will publish its final figures and its Quarterly Statement for the first nine months of 2024 as planned on October 25, 2024.

FURTHER INFORMATION IS AVAILABLE FROM:
STRATEC SE
Jan Keppeler, CFA | Investor Relations, Sustainability & Corporate Communications
Tel: +49 7082 7916-6515
ir@stratec.com
www.stratec.com

End of Inside Information


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Sartorius Stedim Biotech publishes unaudited results for the first nine months of 2024

Sartorius Stedim Biotech SA

/ Key word(s): 9 Month figures

Sartorius Stedim Biotech publishes unaudited results for the first nine months of 2024

17-Oct-2024 / 07:02 CET/CEST

Aubagne, France | October 17, 2024

Sartorius Stedim Biotech publishes unaudited results for the first nine months of 2024
 

  • Sales revenue of 2,029 million euros, organic decline of 3.0 percent in constant currencies1 (reported: – 1.9 percent)
  • Underlying EBITDA1 at 565 million euros, resulting margin at 27.8 percent; net profit1 of 129 million euros
  • Significant growth in order intake for consumables overcompensates for low equipment investments by customers
  • Advanced Therapy Solutions business well on track with above-average growth
  • Outlook for 2024 confirmed

Sartorius Stedim Biotech, a leading partner of the biopharmaceutical industry, closed the first nine months of the fiscal year as expected, with a positive trend in demand and a robust underlying profit margin. The company confirms its full year outlook.

“Over the past months, we have seen a stabilizing business environment: Most customers are about to complete their destocking, leading to an increase in order intake on our side, especially for consumables. We are also encouraged by the above-average performance of our portfolio for advanced therapies. At the same time, many customers are still cautious about investing, which is impacting our equipment business. In terms of profitability, we see a very robust profit margin and expect the highest contribution from our ongoing efficiency program in the fourth quarter,” said René Fáber, CEO of Sartorius Stedim Biotech. “Based on the development of the first nine months, we are confident that we will meet our full-year guidance for 2024 and are optimistic for the future. With the high number of drug approvals and the increasing number of drug candidates entering our customers’ pipelines, Sartorius Stedim Biotech remains well-positioned for long-term growth, offering key solutions to support new therapies for patients worldwide.”

Business development1
Sartorius Stedim Biotech offers a wide range of innovative technologies for the manufacture of biopharmaceuticals such as monoclonal antibodies, vaccines, and cell and gene therapeutics. In the first nine months of the fiscal year, the company recorded sales revenue of 2,029 million euros, which corresponds to a slight decline of 1.3 percent in constant currencies (reported: – 1.9 percent; organic: – 3.0 percent in constant currencies). Sales revenue includes a contribution of 2.5 percent from acquisitions2. As most customers are well progressing with their destocking programs, order intake1 increased by 8.5 percent in constant currencies (reported: +7.7 percent) to 1,895 million euros, with growing demand in the consumables business more than compensating for the still muted equipment business.

Regionally, business performance varied: While in the Americas, sales revenue declined by 9.7 percent against strong prior year comparables and due to the soft equipment business, sales revenue grew by 5.9 percent in EMEA3. and also picked up in Asia Pacific by 1.3 percent, despite a still weak Chinese market.

Underlying EBITDA was down by 4.9 percent to 565 million euros in the first nine months of 2024, mainly due to volume and product mix effects. The respective margin reached a robust 27.8 percent after 28.7 percent in the same period of 2023. Underlying net profit1 was 238 million euros, compared to 320 million euros in the first nine months of 2023. Net profit amounted to 129 million euros after 279 million euros in the prior-year period. Underlying earnings per share stood at 2.46 euros (PY: 3.47 euros) and earnings per share at 1.34 euros (PY: 3.02 euros).

As of September 30, 2024, Sartorius Stedim Biotech employed 10,082 people worldwide, after 10,849 in September 2023 (December 31, 2023: 10,662 people). The reduction resulted primarily from the expiry of fixed-term employment contracts and regular attrition.

Key financial indicators
Sartorius Stedim Biotech’s key financial indicators remain at a highly robust level. Equity was 3,939 million euros as of September 30, 2024, while the equity ratio1 was 49.3 percent (December 31, 2023: 2,674 million euros and 34,6 percent), mainly as a result of the equity measures successfully completed at the beginning of February 2024.

Net operating cash flow increased significantly to 530 million euros compared to 410 million euros in the prior-year period, particularly due to the reduction in working capital. Investments in research and the company’s global production infrastructure amounted to 260 million euros (PY: 371 million euros). The ratio of capital expenditures (capex) to sales revenue was 12.8 percent (PY: 17.9 percent). Gross debt decreased to 2,832 million euros (December 31, 2023: 3,682 million euros), net debt to 2,349 million euros and the ratio of net debt to underlying EBITDA1 to 3.1 as planned (December 31, 2023: 3,565 million euros and 4.5).

Outlook for fiscal 2024 confirmed
Based on the company’s nine-month results, management confirms its guidance for the full year 2024: Sartorius Stedim Biotech continues to expect sales revenue to be at prior-year level, with a bandwidth of low single-digit negative to low single-digit positive development in sales revenue. Acquisitions should contribute around 2 percent to sales revenue. 

In terms of profitability, the underlying EBITDA margin is expected to reach 27 to 29 percent, with a slightly positive effect from the above-average profitability of the Polyplus business. The ongoing efficiency program will contribute more than 85 million euros, while volume effects and the company’s own inventory reduction will have a temporary dilutive effect. The ratio of capital expenditure in relation to sales revenue is forecast to be around 12 percent for the full year, while the ratio of net debt to underlying EBITDA should be approximately 2.5 to 3.0.

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 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, are playing a greater role. This results in higher uncertainty when forecasting business figures.

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
  • Order intake: all customer orders contractually concluded and booked during the respective reporting period
  • 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, and based on the normalized financial result and the normalized tax rate
  • 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 Acquisition of Polyplus
3 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 press release is the legally binding version.

Conference call
Dr. René Fáber, CEO of the Sartorius Stedim Biotech Group, will discuss the company’s 9-month results with analysts and investors in a conference call at 1.00 p.m. CEST on October 17, 2024.
Register here:
https://sar.to/9M_2024

Key Performance Indicators for the first nine months of 2024
 

in millions of € unless otherwise specified 9 months
2024
9 months
2023
¹
Δ in % Δ in % cc²
Order Intake and Sales Revenue        
Order intake3 1,894.9 1,759.6 7.7 8.5
Sales revenue 2,028.7 2,068.7 -1.9 -1.3
  • EMEA4
850.5 804.3 5.7 5.9
  • Americas4
718.6 798.9 -10.1 -9.7
  • Asia | Pacific4
459.6 465.6 -1.3 1.3
Results        
EBITDA5 564.7 594.0 -4.9  
EBITDA margin5 in % 27.8 28.7    
Underlying net profit6 238.0 319.9 -25.6  
Underlying earnings per share6 in € 2.46 3.47 -29.0  
Net profit7 129.5 278.6 -53.5  
Earnings per share7 in € 1.34 3.02 -55.7  

Key Performance Indicators for Q3 2024

in millions of € unless otherwise specified Q3
2024
Q3
20231
Δ in % Δ in % cc2
Order Intake and Sales Revenue        
Order intake3 634.4 617.3 2.8 3.5
Sales revenue 655.4 666.9 -1.7 -1.4
  • EMEA4
276.0 252.9 9.1  
  • Americas4
226.2 273.4 -17.2  
  • Asia | Pacific4
153.2 140.7 8.9  
Results        
EBITDA5 177.4 178.3 -0.5  
EBITDA margin5 in % 27.1 26.7    
Underlying net profit6 73.2 78.4 -6.7  
Underlying earnings per share6 in € 0.76 0.85 -10.6  
Net profit7 25.5 34.4 -25.7  
Earnings per share7 in € 0.26 0.37 -30.2  

1 The previous year’s figures have been revised due to finalization of the purchase price allocation for the acquisition of Polyplus.
2 cc = 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
3 All customer orders contractually concluded and booked during the respective reporting period.
4 Acc. to the customer’s location
5 Earnings before interest, taxes, depreciation and amortization, and adjusted for extraordinary items.
6 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.
7 After non-controlling interest
Figures are not audited nor reviewed.
 

Reconciliation of alternative performance measures

Reconciliation between EBIT and underlying EBITDA

In millions of €
unless otherwise specified
9 months
2024
9 months
2023
¹
EBIT (operating result) 285.6 355.3
Extraordinary items 57.9 75.8
Depreciation and amortization 221.1 162.9
Underlying EBITDA 564.7 594.0

Reconciliation between EBIT and underlying net result
   
In millions of €
unless otherwise specified
9 months
2024
9 months
2023
¹
EBIT (operating result) 285.6 355.3
Extraordinary items 57.9 75.8
Amortization | IFRS 3 87.7 60.9
Normalized financial result² -106.1 -58.3
Normalized income tax (26%)³ -84.6 -112.8
Underlying net result after taxes 240.7 320.9
Non-controlling interest -2.7 -1.0
Underlying net result after taxes and non-controlling interest 238.0 319.9
Underlying earnings per share (in €) 2.46 3.47

1 The previous year’s figures have been revised due to finalization of the purchase price allocation for the acquisition of Polyplus
2 Financial result excluding fair value adjustments of hedging instruments and currency effects relating to financing activities and change in valuation of earn-out liability
3 Normalized income tax based on the underlying profit before taxes and amortization
Figures are not audited nor reviewed.

Calculation of net debt and ratio of net debt to underlying EBITDA

in millions of €
unless otherwise specified
9 months
2024
9 months
2023
¹
Gross debt 2,831.7 3,793.8
–  Cash & cash equivalents 482.6 99.3
Net debt 2,349.1 3,694.5
     
Underlying EBITDA (12 months) 756.1 903.5
+ Pro forma EBITDA from acquisitions (12 months) 0.0 22.5
Pro forma underlying EBITDA (12 months) 756.1 926.0
Ratio of net debt to underlying EBITDA 3.1 4.0

1 The previous year’s figures have been revised due to finalization of the purchase price allocation for the acquisition of Polyplus
Figures are not audited nor reviewed

Calculation of the capital expenditures ratio

in millions of €
unless otherwise specified
9 months
2024
9 months
2023
¹
Sales revenue 2,028.7 2,068.7
Capital expenditures 259.8 370.8
Capital expenditures as % of sales revenue 12.8 17.9

1 The previous year’s figures have been revised due to finalization of the purchase price allocation for the acquisition of Polyplus
Figures are not audited nor reviewed.

A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international partner of 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, safely, rapidly, and economically. The shares of Sartorius Stedim Biotech S.A. are quoted 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 2023, the company generated sales revenue of around 2.8 billion euros. By the end of 2023, more than 10,600 employees were working for customers around the globe.

Visit our newsroom and follow Sartorius Stedim Biotech on LinkedIn.

Contact
Petra Kirchhoff
Head of Corporate Communications & Investor Relations
+49 (0)551 308 1686
petra.kirchhoff@sartorius.com

 


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APONTIS PHARMA and Zentiva enter into investment agreement – Zentiva will launch a voluntary public purchase offer

APONTIS PHARMA AG / Key word(s): Tender Offer

APONTIS PHARMA and Zentiva enter into investment agreement – Zentiva will launch a voluntary public purchase offer

16-Oct-2024 / 11:50 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 AG.

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


Publication of inside information pursuant to Article 17 of the Regulation (EU) No. 596/2014

APONTIS PHARMA and Zentiva enter into investment agreement – Zentiva will launch a voluntary public purchase offer

Monheim / Rhein, 16 October 2024. APONTIS PHARMA AG (“APONTIS PHARMA” or the “Company”, Ticker APPH / ISIN DE000A3CMGM5), Zentiva Pharma GmbH and Zentiva AG (the “Bidder”), both part of the Zentiva group (“Zentiva”), today signed an investment agreement with the aim of supporting the future growth of APONTIS PHARMA. The Bidder will launch a voluntary public purchase offer (the “Offer”) for all outstanding shares of APONTIS PHARMA (the “Shares”) at an offer price of EUR 10.00 per Share in cash.

The offer document (“Offer Document”) will be published on the internet at www.zentiva-offer.com. Since APONTIS PHARMA is not listed on the regulated market, the Offer is not subject to the German Securities Acquisition and Takeover Act (Wertpapiererwerbs- und Übernahmegesetz – WpÜG).

The Offer will be subject to customary conditions, such as the granting of regulatory approvals. It will also include a minimum acceptance threshold of 65% of all Shares. Zentiva has already secured a stake of approximately 37.5% of the Shares by entering into a share sale and purchase agreement with the main shareholder of APONTIS PHARMA.

The Executive Board and the Supervisory Board of APONTIS PHARMA welcome and support the Offer, subject to their review of the Offer Document and in compliance with their fiduciary duties. The members of the Executive Board and Supervisory Board intend to tender all Shares held by them.

In accordance with the investment agreement, APONTIS PHARMA will – subject to all fiduciary duties of the Executive Board – apply for the cancellation of the inclusion of the Shares in over-the-counter (OTC) trading on all stock exchanges on which the Shares are traded.

APONTIS PHARMA AG

Investor Relations
ir@apontis-pharma.de
T: +49 2173 89 55 4900
F: +49 2173 89 55 1521
Alfred-Nobel-Str. 10
40789 Monheim / Rhein
Germany
apontis-pharma.de

APONTIS PHARMA Press Contact

CROSS ALLIANCE communication GmbH
Sven Pauly
ir@apontis-pharma.de
T: +49 89 125 09 0330

Disclaimer – Legal notice

The information contained in this press release may include certain forward-looking statements that are based on current assumptions and forecasts made by the management of APONTIS PHARMA AG. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. Such factors include those discussed in APONTIS PHARMA AG’s public reports. These reports are available on www.apontis-pharma.de. The Company assumes no obligation to update such forward-looking statements or to adapt them to future events or developments.

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APONTIS PHARMA and Zentiva entered into partnership for future growth – Zentiva will launch a voluntary public purchase offer

EQS-News: APONTIS PHARMA AG

/ Key word(s): Tender Offer

APONTIS PHARMA and Zentiva entered into partnership for future growth – Zentiva will launch a voluntary public purchase offer

16.10.2024 / 11:55 CET/CEST

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

APONTIS PHARMA and Zentiva entered into partnership for future growth – Zentiva will launch a voluntary public purchase offer

 

  • APONTIS PHARMA and Zentiva signed an investment agreement today
  • Growth strategy of APONTIS PHARMA to be continued together with Zentiva
  • APONTIS PHARMA to benefit from the European footprint, the existing research and production facilities, and the financial strength of Zentiva
  • Zentiva will offer the shareholders of APONTIS PHARMA AG an offer price of EUR 10.00 per share which corresponds to a premium of 52.9% on the closing price on 15 October 2024 and a premium of 38.3% on the average XETRA closing price for the past three months
  • The Executive Board and the Supervisory Board of APONTIS PHARMA fully support the offer
  • Zentiva has already secured approximately 37.5% of the APONTIS PHARMA shares by entering into a share sale and purchase agreement with the main shareholder

Monheim / Rhein, 16 October 2024. APONTIS PHARMA AG (Ticker APPH / ISIN DE000A3CMGM5) (APONTIS PHARMA), a leading pharmaceutical company specializing in Single Pill combinations in the German market, and Zentiva, a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines, today signed an investment agreement. Under the terms of the agreement, Zentiva will support the future growth of APONTIS PHARMA.

Zentiva AG, a wholly-owned subsidiary of Zentiva Pharma GmbH, headquartered in Frankfurt / Main, Germany, and part of Zentiva group (“Zentiva”), will launch a voluntary public purchase offer (the “Offer”) for all outstanding shares of APONTIS PHARMA at an Offer Price of EUR 10.00 per share in cash. The offer document (“Offer Document”) will be published on the internet at www.zentiva-offer.com. Zentiva is seeking to acquire a majority stake and is setting a minimum acceptance threshold of 65% of the shares.

Zentiva strives for joint further development of APONTIS PHARMA

Zentiva is the largest supplier of generic drugs in Germany, selling over 100 million packages per year. The company has around 5,000 employees at its headquarters in Prague and in 7 subsidiaries. The business model is based on the provision of branded, specialty, OTC and generic drugs. Zentiva has two of its own research and four production sites for this purpose. With this acquisition, both companies aim to deepen their strategic partnership. In addition, increased investments in the APONTIS PHARMA pipeline and an expansion of the number of product launches, as well as collaboration on the potential international expansion of APONTIS PHARMA products and pipeline, are to be realized.

Zentiva will fully support the Executive Board’s growth strategy. The registered office and headquarters of APONTIS PHARMA in Monheim will be retained.

The business strategy of APONTIS PHARMA with its focus on the concept of Single Pill combinations in the cardiovascular area, as well as selective sales activities for third parties, is to be continued and the product pipeline is to be expanded with an increasing share of exclusive contracts or exclusively developed products. The various strong brands of APONTIS PHARMA are very well known in Germany and will continue to be used (including as trademarks on APONTIS PHARMA products).

The Executive Board and the Supervisory Board of APONTIS PHARMA support the Offer

The Executive Board and the Supervisory Board of APONTIS PHARMA welcome and support the Offer, subject to their review of the Offer Document and in compliance with all their fiduciary duties. The Executive Board and Supervisory Board intend to recommend that the shareholders of APONTIS PHARMA accept the Offer. The members of the Boards intend to tender any APONTIS PHARMA shares held by them into the Offer. The Executive Board and the Supervisory Board assume that the Offer is in the best interest of the Company, its shareholders, employees and other stakeholders.

The Management Board and Supervisory Board intend to disclose a joint, reasoned statement on the Offer, which will be published on APONTIS PHARMA’s website.

Steffen Saltofte, CEO of Zentiva: “We are delighted that the Executive Board and the Supervisory Board welcome the Offer as a long-term solution for the company. We firmly believe that under a unified ownership structure, APONTIS PHARMA will be able to provide high-quality and affordable products to even more customers across Europe, while this partnership is an important step towards achieving Zentiva’s long-term strategy and goals.“

Bruno Wohlschlegel, CEO of APONTIS PHARMA, added: “In the past few months, we have fundamentally reorganized the Company, changed structures, implemented cost-cutting measures and strategically realigned our market access. We have received the best possible support from our experienced Supervisory Board under the leadership of Matthias Wiedenfels. APONTIS PHARMA is now in a significantly better position, and we are seeing the first successes of these efforts. The Offer now on the table is proof of the positive development and market relevance of the Single Pill concept. We welcome Zentiva’s interest and support the Offer. We see the merger as an opportunity to enable more patients to benefit from better treatment in a shorter time.”

Dr. Matthias Wiedenfels, Chairman of the Supervisory Board of APONTIS PHARMA: “Bruno Wohlschlegel and his Executive Board team have developed APONTIS PHARMA into a profitable company with great growth potential. We are pleased that the value increases that have been achieved since Bruno Wohlschlegel took office are clearly reflected in Zentiva’s intention to acquire the Company.”

Transaction details

Zentiva offers the shareholders of APONTIS PHARMA AG EUR 10.00 per share in cash. This Offer Price corresponds to a very attractive premium of 52.9% on the XETRA closing price of APONTIS PHARMA shares on 15 October 2024, the last trading day prior to this publication, and 38.3% to the volume-weighted average stock market price (VWAP) over the past three months. Based on the Offer Price, the market capitalization amounts to approximately EUR 85 million.

The Offer will be subject to customary conditions, such as the granting of regulatory approvals. It will also include a minimum acceptance threshold of 65% of all shares. The acceptance period will begin with the publication of the Offer Document. Zentiva has already secured a stake of approximately 37.5% of the APONTIS PHARMA shares by entering into a share sale and purchase agreement with the main shareholder of APONTIS PHARMA.

Zentiva and APONTIS PHARMA have agreed in the investment agreement that APONTIS PHARMA ‘s Executive Board will, to the extent permitted by law and subject to its fiduciary duties, terminate the inclusion of APONTIS PHARMA’s shares in the trading on the open market (Freiverkehr) immediately following the settlement of the Offer. A separate delisting offer will not be required.

Further details and terms of the Offer will be set forth in the Offer Document. As APONTIS PHARMA is not listed on a regulated market, the Offer is not subject to the German Securities Acquisition and Takeover Act (Wertpapiererwerbs- und Übernahmegesetz – WpÜG). The Offer Document (in German and in a non-binding English translation) and other information relating to the Offer will be published on the following website: www.zentiva-offer.com.

About APONTIS PHARMA:

APONTIS PHARMA AG is a leading pharmaceutical company specializing in Single Pill combinations in Germany. Single Pills combine two to three generic active ingredients in a single dosage form administered once a day. Single Pill therapies have been scientifically proven to significantly increase adherence and thus improve the treatment prognosis and quality of life of patients while reducing complications, mortality, and treatment costs. Consequently, Single Pill combinations are the preferred treatment option in numerous international treatment guidelines, including in the EU and Germany. APONTIS PHARMA has been developing, promoting, and distributing a broad portfolio of Single Pill combinations and other pharmaceutical products since 2013, with a special focus on cardiovascular diseases such as hypertension, hyperlipidemia, and secondary prevention. For additional information about APONTIS PHARMA, please visit www.apontis-pharma.de.

APONTIS PHARMA AG

Investor Relations
ir@apontis-pharma.de
T: +49 2173 89 55 4900
F: +49 2173 89 55 1521
Alfred-Nobel-Str. 10
40789 Monheim / Rhein
Germany
apontis-pharma.de

APONTIS PHARMA Press Contact

CROSS ALLIANCE communication GmbH
Sven Pauly
ir@apontis-pharma.de
T: +49 89 125 09 0330

Disclaimer – Legal notice

The information contained in this press release may include certain forward-looking statements that are based on current assumptions and forecasts made by the management of APONTIS PHARMA AG. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. Such factors include those discussed in APONTIS PHARMA AG’s public reports. These reports are available on www.apontis-pharma.de. The Company assumes no obligation to update such forward-looking statements or to adapt them to future events or developments.


16.10.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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Invitation: Straumann Group 2024 third-quarter results webcast

Straumann Holding AG

/ Key word(s): 9 Month figures

Invitation: Straumann Group 2024 third-quarter results webcast

16.10.2024 / 10:16 CET/CEST

Date: Tuesday, October 29, 2024 

Time: 10:30 – 11:30 a.m. CET  

 

Straumann Group will publish its 2024 third-quarter results on Tuesday, October 29, 2024, at approximately 7:00 a.m. CET through the usual channels. 

The live audio webcast is aimed at investors, financial analysts and journalists. The Group’s top management will review the performance and answer participants’ questions. The presentation and Q&A session will be held in English. 

The webcast can be accessed via www.straumann-group.com/webcast. A recording will be available afterwards under the same link. 

If you intend to ask a question during the Q&A session, we kindly ask you to pre-register for the conference call through this link. We also recommend that you download the presentation file in advance using the direct link in the media release on www.straumann-group.com before joining the conference call.  

 

With kind regards 

Straumann Group Corporate Communications & Investor Relations 


End of Media Release


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Formycon published results of analytical similarity study of biosimilar candidate FYB206 and Keytruda® in peer-reviewed journal Drugs in R&D

EQS-News: Formycon AG

/ Key word(s): Scientific publication/Study results

Formycon published results of analytical similarity study of biosimilar candidate FYB206 and Keytruda® in peer-reviewed journal Drugs in R&D

16.10.2024 / 06:50 CET/CEST

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

Press Release // October 16, 2024
 

Formycon published results of analytical similarity study of biosimilar candidate FYB206 and Keytruda® in peer-reviewed journal Drugs in R&D
 

  • The comparative analytical evaluation results indicate that the proposed Keytruda®-biosimilar FYB206 is structurally and functionally highly similar to the reference product
  • Strong analytical results provide a solid foundation for the ongoing clinical trials with FYB206 and underline Formycon’s excellent position in the leading group of pembrolizumab biosimilar developers
     

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announced today that the results of the comparative analytical evaluation of the proposed pembrolizumab biosimilar FYB206 and the immuno-oncology blockbuster drug Keytruda®1 were published in Drugs in R&D, an international, peer-reviewed journal owned by Springer. The paper indicates that FYB206 is structurally and functionally highly similar to the reference product, thereby supporting the testing of the proposed pembrolizumab biosimilar in clinical trials to confirm the similarity between the two products.

To determine FYB206’s suitability to enter clinical trials, a comprehensive comparative analytical assessment was designed to demonstrate analytical similarity in clinically relevant quality attributes between the reference product and the corresponding biosimilar candidate. The analytical panel to evaluate similarity in the current study was designed on the basis of available information on pembrolizumab and knowledge gained during initial analyses of the reference product. The wide battery of qualified and fit for purpose analytical and functional tests was assigned to categories such as structural characterization, product-related variants, glycosylation, general properties, and biological function. All tested functional attributes with a potential impact on clinical performance (PD-1 binding, neutralization of PD-1, FcRn binding) of FYB206 were found to be highly similar to the reference product.

In summary, the results of the extensive data package from all assessments covering structure, purity, protein variants, binding and potency confirm the high similarity between FYB206 and Keytruda®.

Dr. Andreas Seidl, Chief Scientific Officer (CSO) at Formycon, commented: “The remarkable results of this comparative analytical evaluation suggest that FYB206 has the characteristics to be a safe and efficacious alternative to Keytruda®. With this solid foundation, obtained prior to the start of the pharmacokinetic equivalence and confirmatory efficacy and safety trials with FYB206 in June and July 2024, we are committed to continuously initiate new clinical centres and to work closely with the investigators to expand access for patients with high unmet medical needs.”

The full paper entitled “Comparative Analytical Evaluation of the Proposed Biosimilar FYB206 and its Reference Medicinal Product Keytruda®” can be found here.

The active ingredient pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. Pembrolizumab binds to the PD-1 receptor and specifically blocks the interaction between PD-1 and its ligand PD-L1. This helps the immune system to activate the body’s own cellular anti-tumor immune response and kill cancer cells. With its broad range of indications in oncology and the continuing high global demand, sales of this currently best-selling drug worldwide could rise to USD 30 billion by 2026.2

FYB206/pembrolizumab is currently being tested in the pharmacokinetic equivalence trial “Dahlia” to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference product Keytruda® in patients receiving adjuvant treatment for malignant melanoma (black skin cancer). The parallel “Lotus” trial compares the efficacy and safety of FYB206 with Keytruda® in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).

—————

1 Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA

2. https://www.reuters.com/business/healthcare-pharmaceuticals/merck-raises-2024-profit-forecast-strong-cancer-hpv-drugs-sales-2024-04-25/

 

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

Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

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

 

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany
Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

 

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


16.10.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
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Drägerwerk AG & Co. KGaA: Dräger with good demand in the first nine months of 2024

EQS-News: Drägerwerk AG & Co. KGaA

/ Key word(s): Preliminary Results/Forecast

Drägerwerk AG & Co. KGaA: Dräger with good demand in the first nine months of 2024

16.10.2024 / 07:00 CET/CEST

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

Dräger with good demand in the first nine months of 2024

  • Order intake exceeds the high prior-year level
  • Net sales almost reach the strong prior-year figure
  • EBIT up around four percent
  • Annual forecast confirmed

Lübeck – Dräger’s preliminary order intake rose by 1.4 percent (net of currency effects; nominal: 0.7 percent) to around EUR 2,421 million in the first nine months of 2024 and was therefore higher than the prior year’s high level (9 months 2023: EUR 2,403.3 million). In the safety division, order intake rose by 6.5 percent (net of currency effects; nominal: 6.0 percent) to around EUR 1,052 million (9 months 2023: EUR 992.7 million). In the medical division, it decreased by 2.1 percent (net of currency effects; nominal: -3.0 percent) to around EUR 1,368 million (9 months 2023: EUR 1,410.7 million). This was due in particular to the significant decline in demand for ventilators, which had still been supported by China in the first quarter of 2023.

At around EUR 2,295 million, net sales were 0.4 percent (net of currency effects; nominal: -1.1 percent) below the prior-year figure (9 months 2023: EUR 2,320.9 million). In the prior-year period, Dräger had benefited from strong catch-up effects as a result of the noticeable improvement in delivery capacity and the surge in demand for ventilators in China. As expected, both effects were absent in the first nine months of 2024.

The safety division continued its net sales growth in the first nine months of 2024 and recorded an increase of 5.5 percent (net of currency effects; nominal: 5.0 percent) to around EUR 1,010 million (9 months 2023: EUR 961.7 million). The medical division recorded a decline of 4.6 percent (net of currency effects; nominal: -5.4 percent) to around EUR 1,285 million (9 months 2023: EUR 1,359.2 million), which is attributable in particular to the aforementioned base effects in the prior year. The Group’s gross margin rose to around 44.4 percent (9 months 2023: 44.0 percent).

Earnings before interest and taxes (EBIT) increased by around four percent to around EUR 80 million (9 months 2023: EUR 76.9 million). In addition to the operating business performance, several one-time effects with an impact on earnings contributed around EUR 30 million to EBIT in the course of the first nine months.

Business performance in the third quarter of 2024
In the third quarter, order intake increased by 2.6 percent (net of currency effects; nominal: 1.2 percent) to around EUR 816 million (Q3 2023: EUR 806.7 million). In the safety division, it increased significantly by 11.9 percent (net of currency effects; nominal: 10.9 percent) to around EUR 348 million (Q3 2023: EUR 313.5 million). In the medical division, it decreased by 3.4 percent (net of currency effects; nominal: -5.0 percent) to around EUR 468 million (Q3 2023: EUR 493.1 million).

At around EUR 775 million, net sales were 0.7 percent below (net of currency effects; nominal: -1.8 percent) the prior-year figure (Q3 2023: EUR 788.5 million). The safety division recorded a decrease of 0.6 percent (net of currency effects; nominal: -1.3 percent) to around EUR 336 million (Q3 2023: EUR 340.1 million). The medical division recorded a decline of 0.8 percent (net of currency effects; nominal: -2.1 percent) to around EUR 439 million (Q3 2023: EUR 448.4 million). This is due in particular to the weak development in China. The Group’s gross margin stood at around 43.5 percent (Q3 2023: 44.0 percent). EBIT amounted to around EUR 24 million (Q3 2023: EUR 29.2 million). This included a one-time effect of around EUR 10 million from a sale of a building. The EBIT margin amounted to around 3.1 percent (Q3 2023: 3.7 percent).

Dräger confirms its outlook for the current fiscal year and expects net sales to increase by 1.0 to 5.0 percent (net of currency effects) and an EBIT margin of 2.5 to 5.5 percent. We continue to expect net sales growth in the lower half and an EBIT margin in the upper half of the forecast range.

The full results for the first nine months of the fiscal year will be published on October 29, 2024.

Disclaimer
This press release 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. Information on the financial indicators used (incl. alternative performance measures) can be found on our corporate website www.draeger.com in our Investor Relations section.


16.10.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
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aap Implantate AG: Possible cyber attack on aap

aap Implantate AG / Key word(s): Miscellaneous

aap Implantate AG: Possible cyber attack on aap

15-Oct-2024 / 23:25 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 AG.

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


aap Implantate AG (the “Company”) determined that there may have been a cyber attack on the Company’s IT systems. In response, the Company proactively disconnected the systems from the internet to prevent data breaches and data corruption. The IT systems and the extent of the impact are currently being reviewed. In doing so, the utmost care is being taken to ensure data integrity.

 

 

Contact:

aap Implantate AG; R. Di Girolamo; Chairman of the Management Board / CEO; Lorenzweg 5; D-12099 Berlin

Tel.: +49/30/750 19 – 170; Fax: +49/30/750 19 – 290; r.digirolamo@aap.de

 

End of Inside Information


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Eckert & Ziegler Again Increases Sales and Earnings in the First Nine Months Compared to Previous Year

Eckert & Ziegler SE / Key word(s): 9 Month figures/Preliminary Results

Eckert & Ziegler Again Increases Sales and Earnings in the First Nine Months Compared to Previous Year

15-Oct-2024 / 16:33 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 AG.

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


3rd quarter of 2024:

  • Sales of EUR 70.1 million (previous year: EUR 65.9 million)
  • EBIT before special items of EUR 15.5 million (previous year: EUR 15.1 million)
  • Net income of EUR 5.3 million (previous year: EUR 9.4 million) 

First 9 months of 2024: 

  • Sales of EUR 215.5 million (previous year: EUR 183.9 million)
  • EBIT before special items of EUR 46.7 million (previous year: EUR 37.7 million)
  • Net income of EUR 23.4 million (previous year: EUR 20.3 million) 

Forecast for 2024: 

  • Sales of just under EUR 265 million (confirmed)
  • EBIT before special items of around EUR 55 million (confirmed)

Berlin, 15 October 2024. According to preliminary calculations, Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) generated sales of EUR 215.5 million in the first nine months of 2024 (previous year: EUR 183.9 million). The key figure EBIT before special items, introduced as part of the 2024 forecast, amounted to EUR 46.7 million in the first nine months of 2024 (previous year: EUR 37.7 million). Net profit, which is only reported here on a comparative basis, increased to EUR 23.4 million (previous year: EUR 20.3 million).

The forecast for the 2024 financial year published on July 16, 2024, remains confirmed. The Executive Board continues to expect sales of just under EUR 265 million and EBIT before special items of around EUR 55 million.

The full figures for the first nine months of 2024 will be published on November 14, 2024.

Contact:
Eckert & Ziegler SE, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-138, karolin.riehle@ezag.de, www.ezag.com 

 

End of Inside Information


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