Medacta unveils the extended enhancements to its Hip Revision Platform

Medacta Group SA

/ Key word(s): Miscellaneous

Medacta unveils the extended enhancements to its Hip Revision Platform

21.10.2024 / 19:00 CET/CEST

MEDIA RELEASE

Medacta unveils the extended enhancements to its Hip Revision Platform

CASTEL SAN PIETRO, October 21, 2024—Medacta Group SA (“Medacta,” SIX:MOVE) is pleased to announce the further expansion of its comprehensive Hip Revision Platform in the European market, reinforcing its commitment to providing innovative solutions for complex hip revision procedures. The expanded Hip Revision Platform now features a complete femoral and acetabular portfolio designed to address various levels of surgical complexity, supported by a medical education program delivered by esteemed Key Opinion Leaders.

“Medacta has always made substantial investments in R&D to empower surgeons to restore the patient’s anatomy, ranging from minimally invasive primary cases to highly complex hip revision surgeries. Our focus has been on maximizing the versatility of our implants and instruments while minimizing the complexity of the surgical flow,” says Francesco Siccardi, CEO of Medacta.

FEMUR
On the femoral side, the M-Vizion Femoral Revision System has been designed to deliver maximum stability and versatility with a simplified and streamlined procedure. Alongside a modular version available with a straight as well as a 4° taper, to address surgeon preferences and patient indications, M-Vizion Monobloc was introduced into the market with positive results. With the first cases of M-Vizion Distal Locking designed to solve complex cases through distal mechanical fixation, the M-Vizion Femoral System is being further expanded.

In addition to the M-Vizion Femoral Revision System, Medacta enables surgeons to address different levels of complexity with various solutions, including a long-cemented stem, AMIS-K Long, and a cementless monoblock triple taper long stem, QUADRA-R.

ACETABULUM
With the Mpact System, Medacta offers a complete and versatile acetabular revision portfolio to deal with increasing levels of complexity, addressing both surgeon preferences and patient indications: from multi-hole and rim-hole cups to cages and iliac fixation cups.

Medacta’s Hip Revision Acetabular solutions feature 3D Metal, a state-of-the-art advanced biomaterial structure which allows for engineering implants featuring maximized initial stability and enhanced connection with the bone, both of which are key aspects in revision hip arthroplasty.

Iliac Screw Mpact 3D Metal, a modular cup characterized by iliac fixation indicated for dysplasia, complex revisions and trauma cases has delivered positive results. Also, 3D Metal B-Cage, an anatomical cage compatible with dual mobility cemented cups and compression polyaxial locking screws for additional stability, has shown good results at follow-up. For complex cases in which a modular construct is preferred, 3D Metal Foam and Medacta F-Cage, a cup and cage construct, is available. This solution can be used in combination with 3D Metal Augments II to cover severe bone defects. 3D Metal Augments II can be coupled with Mpact System as well as with cemented cups.

Doz. Dr. Hofstätter, Austria, remarked, “Medacta’s hip revision portfolio offers a wide range of femoral and acetabular solutions that allow surgeons to effectively address different levels of complexity according to their preferences. Depending on the patient’s indication, the surgeons can manage revisions with short stems and standard stems with and without collar or have the option for longer modular/monoblock Wagner type femoral stems and choose among various acetabular solutions, the best solution to solve complex bone defects.”

To support the adoption of these advanced solutions, Medacta offers tailored medical education activities delivered by esteemed Key Opinion Leaders (KOLs). “Acetabular revision cases can be challenging, hence being confident with the implant and the relative instruments is key to achieve good results. Scientific sessions including case discussions, hands-on wetlabs, and one-to-one surgery support by international KOLs enable surgeons to gain experience with the products, help them shorten the learning curve and create connections with the Experts peers,“ concludes Prof. Randelli, Italy.

Medacta remains committed to advancing hip revision research, addressing increasingly complex clinical challenges, and developing personalized solutions to enhance patient outcomes and quality of life.

Medacta’s Hip Revision solutions as part of the comprehensive hip portfolio including primary, minimal invasive approaches and personalized technologies will be showcased at the main congresses in Europe: DKOU in Berlin (22-25 October), SIOT in Rome (29-31 October), and SOFCOT in Paris (11-13 November).

For more information, please visit hip.medacta.com

 

Contact
Gianluca Olgiati
Group Vice President Marketing
+41 91 696 60 60
media@medacta.ch

Medacta is a key global player specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgery. Established in 1999 in Switzerland, Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Through close collaboration with expert surgeons globally, continuous investments in R&D, and the adoption of cutting-edge technologies, Medacta’s innovation prioritizes minimally invasive surgery and personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 60 countries. Follow us on Medacta TV, YouTube, LinkedIn and X.

RELATED TRADEMARKS

Medacta Group Related Trademarks are registered at least in Switzerland. The products and services listed below may not be all-inclusive, and other Medacta products and services not listed below may be covered by one or more trademarks. The following products and services may be covered by additional trademarks not listed below. Note that Swiss trademarks may have foreign counterparts. MySolutions™ Personalized Ecosystem, M-Vizion®, AMIS®-K Long, Quadra®-R, Mpact® System.


Additional features:

File: Medacta unveils the extended enhancements to its Hip Revision Platform


End of Media Release


show this

Mainz Biomed Reports Mid-Year 2024 Financial Results and Provides Corporate Update

Issuer: Mainz BioMed N.V.

/ Key word(s): Half Year Results

21.10.2024 / 14:01 CET/CEST

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

Mainz Biomed Reports Mid-Year 2024 Financial Results and Provides Corporate Update

Revenue increases 4% year over year while loss from operations decreases by 32%

Pooled Results of ColoFuture and eAArly DETECT studies published at ASCO showing groundbreaking performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 95.8% detection of high-grade dysplasia

Company highlights its path to success for 2025

BERKELEY, US – MAINZ, Germany – October 21, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today financial results for the first half of 2024, an update on 2024 accomplishments, and its outlook for the end of the year and strategic direction for 2025. 

Key 2024 Accomplishments

  • During the first six months of 2024, the Company’s revenue increased by 4% year over year while the loss from operations and net loss decreased by 32% and 26%, respectively. These decreases are the result of the Company’s efforts to reduce costs during the first half of the year.
  • Mainz Biomed published key findings from its groundbreaking eAArly DETECT study during a poster presentation at the renowned Digestive Disease Week (DDW) 2024 in Washington D.C. The Company was awarded as a Poster of Distinction by the Digestive Disease Week judges for the presentation of industry leading results: 97% sensitivity for colorectal cancer (CRC) and 82% for advanced precancerous lesions. The eAArly DETECT results demonstrated that within the advanced precancerous lesion patients, 100% of those patients with high grade dysplasia were detected.
  • The Company presented pivotal data from its largest cohort to date during a poster presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, Illinois. This data combined results from the ColoFuture and eAArly DETECT studies including additional patient samples collected since the first reported study results, demonstrating the significance of its innovative screening approach. The new study data confirmed previous ColoFuture and eAArly DETECT study performance with sensitivity for CRC of 92% and 82% for advanced adenomas, including 96% detection of high-grade dysplasia.
  • The Company announced significant improvements to its ColoAlert® product, currently being commercialized across Europe and in select international markets. These updates aim to enhance customer satisfaction and streamline lab operations. To increase screening/lab efficiency, Mainz Biomed introduced a novel DNA stabilizing buffer capable of accommodating varying sample volumes, addressing a common issue in the industry where samples are often either underfilled or overfilled, rendering them unsuitable for laboratory analysis. The new proprietary buffer used in ColoAlert® significantly reduces the necessity for additional sample submissions, thereby decreasing the time for the patients to obtain their results. This enhancement has enabled ColoAlert® to achieve the industry’s lowest retesting rates, ensuring that screening outcomes are delivered within just 2 – 3 days upon arrival at the laboratory. 
  • The Company expanded its collaboration with Liquid Biosciences to Mainz Biomed’s next-generation detection test for pancreatic cancer. The companies are leveraging Liquid Biosciences proprietary AI analysis technology platform (EMERGE) to extend and optimize the selection of novel biomarkers for PancAlert. The first phase of the collaboration included the evaluation of biomarkers from the Company’s research program co-funded by the German Federal Ministry for Education and Research, and applied a single algorithm developed by Liquid Biosciences using its EMERGE platform. The results of this feasibility analysis were promising, leading the Company and Liquid Biosciences to believe that a PancAlert diagnostic test could, in the future, be combined with Mainz Biomed’s colorectal cancer screening product.

Post-period Update

  • In September 2024, Mainz Biomed announced encouraging feedback received from the FDA for the breakthrough device designation with the request to expand the current clinical data set with additional average risk population.
  • In October 2024, the Company made the strategic decision to focus its efforts on three key initiatives for the remainder of 2024 and into 2025 in order to maximize shareholder value. Those initiatives are:
    • The continued growth of its ColoAlert® business in Europe;
    • Development of its next generation colorectal cancer screening product; and
    • Running a 2,000 patient study, with average risk patients in the U.S., to read out in the second half of 2025 (eAArly DETECT 2). With eAArly DETECT 2, the Company addresses the recent FDA feedback and prepares for a new submission for breakthrough device designation with an expanded data set, including a larger average-risk patient population.

In line with these strategic initiatives, the Company restructured its operations and implemented cost reductions which included decreasing its operating costs, primarily driven by the reduction of personnel and external consulting costs.

“2024 has been a transitional year for Mainz Biomed. While navigating through a period of difficult markets, especially for small cap technology stocks, we are proud to have achieved many significant accomplishments to date,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “As the Board and management team evaluated our path forward, we believe that a narrower focus on key strategic initiatives gives us the best opportunity to unlock shareholder value in the remainder of 2024 and 2025.”

Condensed Consolidated Financial Statements (unaudited):

Mainz Biomed N.V.
Condensed Consolidated Statements of Profit or Loss and Comprehensive Loss (unaudited)
(in U.S. Dollars)
               
    Six months ended  
    June 30,  
    2024   2023  
               
  Revenue $ 520,773   $ 499,049  
  Cost of sales   201,735     211,310  
  Product margin   319,038     287,739  
      61%     58%  
  Operating expenses:   .        
  Sales and marketing   2,361,105     3,992,975  
  Research and development   3,242,622     5,481,229  
  General and administrative   4,522,639     5,227,181  
  Total operating expenses   10,126,366     14,701,385  
               
  Loss from operations    (9,807,328)      (14,413,646)  
               
  Other income (expense)            
  Other income   105,851     125,968  
  Change in fair value of convertible debt    (528,210)     45,000  
  Finance expense   –        (250,000)  
  Accretion and interest expense    (659,473)      (88,759)  
  Other expense    (134,602)      (231,206)  
  Total other income (expense)    (1,216,434)      (398,997)  
               
  Income (loss) before income tax    (11,023,762)      (14,812,643)  
  Income taxes provision                             –                                  –    
  Net loss $  (11,023,762)   $  (14,812,643)  
               
  Foreign currency translation gain (loss)    (62,366)      (150,596)  
  Comprehensive loss $  (11,086,128)   $  (14,963,239)  
               
  Basic and diluted loss per ordinary share $  (0.49)   $  (1.00)  
  Weighted average number of ordinary shares outstanding   22,350,033     14,803,243  
               

Condensed Consolidated Financial Statements (unaudited):
 

Mainz Biomed N.V.
Condensed Consolidated Statements of Financial Position (unaudited)
(in U.S. Dollars)
      June 30,   December 31,
      2024   2023
ASSETS            
Current Assets            
  Cash   $                    977,764   $              7,070,925
  Trade and other receivables, net                        139,414                       93,555
  Inventories                        520,531                     613,638
  Prepaid expenses and other current assets                        751,994                  1,201,778
Total Current Assets                     2,389,703                  8,979,896
               
  Property and equipment, net                     1,625,373                  1,702,317
  Intangible assets                     3,206,054                  3,394,645
  Right-of-use assets                     1,232,900                  1,332,170
  Other assets                                 –        
  Total assets   $                 8,454,030   $            15,409,028
                   
LIABILITIES AND SHAREHOLDERS’ EQUITY            
Current Liabilities            
  Accounts payable and accrued liabilities   $                 2,903,873   $              3,184,381
  Accounts payable and accrued expense – related party                        426,637                     299,936
  Deferred revenue                        116,679                     138,889
  Convertible debt                     5,842,003                  4,903,310
  Convertible debt – related party                          32,140                       33,118
  Silent partnership                          49,036                              –  
  Intellectual property acquisition liability – related party                        324,003                     388,839
  Lease liabilities                        319,573                     288,463
Total current liabilities                   10,013,944                  9,236,936
               
  Silent partnerships                        713,856                     758,812
  Silent partnerships – related party                        267,206                     271,354
  Lease liabilities                     1,046,163                  1,165,723
  Intellectual property acquisition liability – related party                        551,561                     726,977
  Total Liabilities                   12,592,730                12,159,802
                       
Shareholders’ equity            
Share capital                        276,378                     235,818
Share premium                   54,136,785                51,507,526
Reserve                   22,314,598                21,286,215
Accumulated deficit                 (80,351,783)              (69,328,021)
Accumulated other comprehensive income (loss)                      (514,678)                   (452,312)
Total shareholders’ equity                   (4,138,700)                  3,249,226
               
Total liabilities and shareholders’ equity   $                 8,454,030   $            15,409,028

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

Please follow us to stay up to date:
LinkedIn
X (Previously Twitter)
Facebook

About Mainz Biomed NV

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, a non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer with high sensitivity and specificity. ColoAlert® is marketed in Europe and the United Arab Emirates. The Company is currently preparing a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact info@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.


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.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


show this

Relief Therapeutics Receives Notice of Allowance for European Patent Covering RLF-TD011 for Epidermolysis Bullosa Wound Treatment

Relief Therapeutics Holding SA / Key word(s): Patent

21-Oct-2024 / 07:00 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

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


Relief Therapeutics Receives Notice of Allowance for European Patent Covering RLF-TD011 for Epidermolysis Bullosa Wound Treatment

GENEVA (OCT. 21, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTFRLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today reported that the European Patent Office (EPO) has issued a Notice of Allowance under Rule 71(3) EPC for Relief’s patent application No. 20737588.2, titled “Therapeutic Uses of Oxidizing Hypotonic Acid Solutions.” This Notice of Allowance signifies the EPO’s intention to grant a patent covering Relief’s proprietary, highly pure hypochlorous acid solutions, including its investigational drug RLF‑TD011 intended for the treatment of wounds caused by epidermolysis bullosa (EB).

Upon completion of the grant procedure, the patent will protect RLF-TD011 in key European countries until 2040. Corresponding applications in other major markets, including the U.S. and China, are currently under review. RLF-TD011 previously received orphan drug designation (ODD) from the U.S. Food and Drug Administration for EB, providing potential incentives such as market exclusivity upon approval.

Giorgio Reiner, chief scientific officer of Relief, said: “We are very pleased with this news. The anticipated grant of this patent represents an additional validation of our efforts to develop novel treatments for rare and devastating diseases like EB. This patent will strengthen the protection of our innovation as we continue advancing RLF-TD011’s development, with the ultimate goal of reaching patients who need it most.”

ABOUT RLF-TD011
RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief’s proprietary TEHCLO™ technology. With strong antimicrobial properties, RLF-TD011 is a sprayable, self-administered solution for targeted wound application while avoiding skin contact and cross-contamination. RLF-TD011 has shown efficacy in accelerating wound closure and reducing infections in certain clinical trials on non-EB wounds. In preliminary cases, EB patients using RLF-TD011 showed improvements in blistering and tissue repair. Currently under clinical development, RLF-TD011 has the potential to offer an innovative solution for EB wound care management. The U.S. Food and Drug Administration granted it orphan drug designation for EB, and Relief plans to seek qualified infectious disease product (QIDP) designation for extended market exclusivity.

ABOUT EPIDERMOLYSIS BULLOSA
Epidermolysis bullosa (EB) is a group of rare, inherited connective tissue disorders characterized by extreme skin fragility, leading to blistering and wounds from minor friction or injury. In severe cases, blisters can develop into chronic wounds or form in internal organs such as the mouth or esophagus. EB affects approximately 1 in 20,000 births in the United States, while the global prevalence of epidermolysis bullosa simplex (EBS) ranges from 1 in 85,000 to 1 in 500,000.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

CONTACT:
RELIEF THERAPEUTICS Holding SA

Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief’s filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief’s filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.

Additional features:

File: Ad hoc


End of Inside Information


show this

Pentixapharm’s CXCR4 Core Compound Subject of 17 Abstract Presentations at the Hamburg European Association of Nuclear Medicine (EANM)

EQS-News: Pentixapharm Holding AG

/ Key word(s): Conference

Pentixapharm’s CXCR4 Core Compound Subject of 17 Abstract Presentations at the Hamburg European Association of Nuclear Medicine (EANM)

19.10.2024 / 12:28 CET/CEST

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

Hamburg, Germany, October 19, 2024 – The CXCR4 targeting compounds developed clinically by Pentixapharm in a number of diagnostic and therapeutic indications are subject of 17 abstract presentations at the 37th Annual Congress of the European Association of Nuclear Medicine (EANM) which takes place in Hamburg from 19 – 23 October 2024. The presentations feature the company’s ongoing theranostic development efforts and CXCR4 targeting research initiatives in areas such as primary aldosteronism, high-grade gliomas, muscle invasive bladder cancer, multiple myeloma, as well as in cardiovascular disease and inflammation. On the economic side, there is an assessment of the economic implications of CXCR4-directed molecular imaging.

Dr. Dirk Pleimes, Pentixapharm’s Chief Medical Officer, commented, “We are excited about the opportunity to highlight the many applications of CXCR4 targeting compounds and the work of our collaborators at one the largest gatherings of nuclear medicine professionals globally. The abstracts accepted from investigator-initiated studies supported by Pentixapharm and others also demonstrate the ongoing interest of academia in CXCR4 and the still untapped potential. We look forward to welcoming friends and collaborators at Pentixapharm’s booth in Hall H, stand H19 for updates and discussions”.

A list of abstracts presentations featuring CXCR4 targeting compounds can be found here.

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.

For more information, please contact:

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


19.10.2024 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.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


show this

aap Implantate AG: Step-by-step restart of IT systems

aap Implantate AG / Key word(s): Miscellaneous

aap Implantate AG: Step-by-step restart of IT systems

18-Oct-2024 / 22:14 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”) announces with reference to the ad hoc release published on October 15, 2024 at 11:25 p.m. regarding a possible cyberattack that the company’s IT systems are being restarted step by step. Production was resumed after a short interruption and was almost unaffected. The ad hoc announcement on October 15, 2024 was directly preceded by information provided to the Company by the relevant investigating authorities regarding investigations initiated ex officio on suspicion of a cyberattack on the Company. According to the ongoing internal investigation of the incident by IT specialists and the latest information provided to the Company by the investigating authorities, it can be assumed at this point in time that no irregularities, in particular data outflows, have occurred. The Company expects to be able to resume normal operations by the end of next week.

 

Contact:

If you have any questions, please 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


18-Oct-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


show this

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.


18-Oct-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


show this

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


17-Oct-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


show this

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

 


Attachment

File: 241017_SSB_Media Release_9M_2024_en


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


show this

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.

End of Inside Information


16-Oct-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


show this

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.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


show this