Biotest AG: Biotest is developing with Trimodulin a COVID-19 therapy for patients with a severe course of the disease

DGAP-News: Biotest AG

/ Key word(s): Research Update

03.04.2020 / 13:51

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

PRESS RELEASE

Biotest is developing with Trimodulin a COVID-19 therapy for patients with a severe course of the disease

– Highly innovative plasma protein product with great therapeutic potential

– Existing study shows: Trimodulin can significantly reduce mortality in mechanically ventilated patients with severe pneumonia

– Mode of action transferable to patients with Covid-19 induced pneumonia

– With additional funding, patients could benefit in current pandemic

– Biotest has already invested a three-digit million amount in drug development and a new production plant

Dreieich, 3 April 2020. Biotest’s innovative antibody product Trimodulin (IgM Concentrate) is ready for advanced clinical testing in Covid-19 patients.

Very good results have already been achieved in a large-scale Phase II study in mechanically ventilated patients with severe pneumonia (severe Community Acquired Pneumonia = sCAP) (CIGMA study). This group of diseases also includes pneumonia caused by the current coronavirus in critically ill patients.

Trimodulin is administered as a adjunct to standard therapy such as antiviral or antibiotic therapy, and intensive care. In the CIGMA study, a relative reduction in mortality of 50-70% was observed in a subgroup of patients with high inflammation markers and/or reduced immune function (low immunoglobulin M levels).[1]

The same conditions also occur in Covid-19 patients with severe course of the disease. According to previous studies, the mode of action of Trimodulin includes not only the ability to support the immunological control of pathogens, but also the ability to dampen an excessive malfunction of the immune system and an excessive inflammation reaction.

Due to the great similarity of the clinical picture to the patients treated in the CIGMA study, Biotest sees Trimodulin as having considerable potential for patients with severe pneumonia after Covid-19 infection. Another IgM- and IgA-enriched immunoglobulin of Biotest AG, Pentaglobin(R), has already shown positive results treating f coronavirus infections (SARS 2002/03).[2] No data are yet available on the treatment of Covid-19 with Pentaglobin(R).

That is why Biotest is now expanding its planned Phase III study in sCAP to include Covid-19 patients. At the same time, an accelerated phase II study in Covid-19 patients is planned in order to drastically accelerate the development in response to the current Covid-19 pandemic. Biotest has already applied for European funding for the activities necessary to speed up the development. With Trimodulin, Biotest is developing a promising therapeutic option that could help saving numerous lives.

Biotest has already invested a three-digit million Euro amount in the development of Trimodulin and the associated new production facility. The funding programs for such advanced clinically innovative approaches for the therapy of Covid-19 are unfortunately still small and very limited. In this context, Biotest is hoping for more public support to accelerate drug development in this critical phase of the COVID-19 pandemic.

About Severe Community-Acquired Pneumonia (sCAP)
Severe Community-Acquired Pneumonia (sCAP) is usually defined as pneumonia acquired outside the hospital that requires intensive medical care. Mortality of sCAP patients admitted to the Intensive Care Unit (ICU) is up to 23-58 % depending on time and admission of the patient and has not improved much in recent years.

About Trimodulin (IgM Concentrate)
Trimodulin (IgM Concentrate) is an innovative immunoglobulin therapeutic derived from human blood plasma with a high content of IgG, IgM and IgA, which is currently being developed for the treatment of severe community-acquired pneumonia (sCAP). According to previous studies, Trimodulin (IgM Concentrate) acts through a wide range of mechanisms interfering pathophysiological processes, which otherwise could lead to severe respiratory disturbances, severe sepsis, multi organ failure and ultimately death of the patient. Besides neutralisation of bacterial endotoxin and exotoxin, IgM mediates increased recognition of pathogens by certain immune cells and promotes their destruction. In addition, IgM can rebalance excessive immune responses and possesses anti-inflammatory properties.

About Pentaglobin(R)
Pentaglobin(R) is the first and only IgM-enriched immunoglobulin preparation for intravenous use. Pentaglobin(R) significantly increases the survival rate of patients with severe bacterial infections and acts against a broad spectrum of bacterial pathogens. Pentaglobin’s(R) mode of action, is both anti-bacterial by fast neutralization of bacterial endo- and exotoxins and anti-inflammatory by scavenging excessively activated complement factors. Pentaglobin(R) is licensed in several countries, mainly for the treatment of severe bacterial infections in combination with antibiotics.

About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 1,800 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

IR contact
Dr Monika Buttkereit
Phone: +49-6103-801-4406
Mail: investor_relations@biotest.de

PR contact
Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

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

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
Preference shares: securities’ ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

[1] Welte et al., Intensive Care Med 2018; 44(4): 438-448
[2] Ho et al, IntJ TubercLung Dis 2004, Oct. 8(10):1173-9


03.04.2020 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Germany
Phone: 0 61 03 – 8 01-0
Fax: 0 61 03 – 8 01-150
E-mail: investor_relations@biotest.de
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1015013

 
End of News DGAP News Service

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Beiersdorf Aktiengesellschaft: Impact of the corona crisis on business performance in 2020 – Beiersdorf withdraws guidance for fiscal year 2020

Beiersdorf Aktiengesellschaft / Key word(s): Development of Sales/Change in Forecast

Beiersdorf Aktiengesellschaft: Impact of the corona crisis on business performance in 2020 – Beiersdorf withdraws guidance for fiscal year 2020

02-Apr-2020 / 18:33 CET/CEST

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

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


Impact of the corona crisis on business performance in 2020 – Beiersdorf withdraws guidance for fiscal year 2020

Beiersdorf Aktiengesellschaft, Hamburg, expects the global spread of the corona-19 virus to have a significant impact on its business performance in 2020.

According to preliminary figures, Group sales fell like-for-like by -3.6% to €1,910 million year over year in the first quarter of the fiscal year. Sales growth generated by the Consumer business segment during the first quarter totaled like-for-like -3.3% (sales of €1,581 million) against the prior-year quarter. Sales growth at the tesa business segment totaled like-for-like -5.1% (sales of €329 million).

For the entire 2020 fiscal year, the company is unable to currently project the potential impact that the corona crisis could have on its business performance. For this reason, the targets set in the company’s guidance issued on March 3, 2020, are unlikely to be achieved. The company has withdrawn this guidance as a result.

The company’s quarterly report about its performance from January through March 2020 will be released on May 5, 2020.

Contact:
Dr. Jens Geißler
Head of Investor Relations
Tel.: +49 (40) 4909 5000
Fax: +49 (40) 4909 18 5000

Inken Hollmann-Peters
Vice President Corporate Communications
Tel.: +49 (40) 4909 2001
Fax: +49 (40) 4909 2516


02-Apr-2020 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: Beiersdorf Aktiengesellschaft
Unnastraße 48
20245 Hamburg
Germany
Phone: +49 (0)40 4909-0
Fax: +49 (0)40 4909-34 34
E-mail: kontakt@Beiersdorf.com
Internet: www.Beiersdorf.com
ISIN: DE0005200000
WKN: 520000
Indices: DAX
Listed: Regulated Market in Frankfurt (Prime Standard), Hamburg; Regulated Unofficial Market in Berlin, Dusseldorf, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1014499

 
End of Announcement DGAP News Service

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PAION CLOSES ENROLLMENT IN EU PHASE III TRIAL WITH REMIMAZOLAM IN GENERAL ANESTHESIA

DGAP-News: PAION AG

/ Key word(s): Research Update

02.04.2020 / 13:00

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

PAION CLOSES ENROLLMENT IN EU PHASE III TRIAL WITH REMIMAZOLAM IN GENERAL ANESTHESIA

424 patients have been enrolled representing a sufficient number to conduct the planned statistical analyses

– Data monitoring committee has agreed to close the trial with the current number of patients

– Topline study results expected in H2 2020, timeline for MAA submission confirmed

Aachen (Germany), 02 April 2020 – The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces the close of patient recruitment in the EU Phase III trial with remimazolam, an ultra-short-acting benzodiazepine sedative/anesthetic, for the induction and maintenance of general anesthesia.

The randomized, single-blind, propofol-controlled, confirmatory Phase III trial was expected to enroll approximately 500 ASA III/IV patients (American Society of Anesthesiologists classification III to IV) undergoing planned surgery at more than 20 European sites. Due to the coronavirus pandemic, patient recruitment was completed at 424 patients agreed to by the Data Monitoring Committee.

PAION believes that these data will provide sufficient statistical power to conduct analyses of the primary and secondary endpoints of the trial. Data from Phase III trials conducted by our licensees in South Korea and Russia will provide additional safety data in the general anesthesia indication.

Topline data are expected in the second half of 2020 and the timeline for preparing regulatory submission following the anticipated approval of remimazolam in procedural sedation in the EU remains unchanged.

The primary objective of the trial is to demonstrate the non-inferiority of remimazolam compared to propofol for the induction and maintenance of general anesthesia during elective surgery. The key secondary objective is to show improved hemodynamic stability (avoidance of intraoperative drop of blood pressure and vasopressor usage) compared to propofol.

Based on Scientific Advice obtained from the European Medicines Agency (EMA) in January 2018, PAION expects that a positive Phase III trial in combination with previously completed clinical studies in Europe, South Korea, Russia and Japan should be sufficient for market approval in the indication of general anesthesia in the EU.

Assuming approval of the Marketing Authorization Application (MAA) in procedural sedation and positive results in this Phase III trial in general anesthesia, PAION plans to submit an extension of the marketing authorization application for remimazolam for general anesthesia. The review process for an extension is generally faster than for an MAA. The complete data from the EU Phase III study in general anesthesia, which are required for the submission of an extension of marketing authorization application, are expected to be available at the time of the regulatory decision on the MAA in procedural sedation. PAION is allowed to submit an extension for general anesthesia after the EMA’s decision on the MAA in procedural sedation at the earliest.

Dr. Jim Phillips, CEO of PAION AG, commented: “Following discussion with the Data Monitoring Committee and a careful assessment of the current situation, given the ongoing coronavirus pandemic, we believe it is the right decision to stop recruitment in the remimazolam Phase III trial in general anesthesia now.

The statistical powering of the study means that we are confident that we can report both primary and secondary endpoints in the analysis. We look forward to obtaining topline data in the second half of 2020 and, if all goes as expected, preparing for a regulatory submission following the anticipated approval of remimazolam in procedural sedation in the EU.

We would like to thank all of the hospitals participating in the Phase III study for their work with our trial and we give thanks to all our healthcare colleagues & centres for their work now to combat the Covid-19 pandemic.”

###

About remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and is not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary. In clinical studies, remimazolam demonstrated efficacy and safety in around 2,500 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.

In Japan, licensee Mundipharma received market approval in general anesthesia in January 2020. In the U.S., licensee Cosmo Pharmaceuticals submitted a New Drug Application for procedural sedation in April 2019, with a PDUFA decision date of 05 July 2020. In China, licensee Yichang Humanwell filed for market approval in procedural sedation in November 2018. In South Korea, licensee Hana Pharm filed for market approval in general anesthesia in December 2019. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019 and results of an EU Phase III trial in general anesthesia are expected in the second half of 2020.

In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.

Remimazolam is partnered in the U.S. (Cosmo Pharmaceuticals, sublicensed to Acacia Pharma), Japan (Mundipharma), China (Yichang Humanwell), Canada (Pharmascience), Russia/CIS, Turkey and the MENA region
(R-Pharm) as well as South Korea and Southeast Asia (Hana Pharm). For all other markets including parts of the EU, remimazolam is available for licensing.

About PAION
PAION AG is a publicly listed specialty pharmaceutical company developing and aiming to commercialize innovative drugs for out-patient and hospital-based sedation, anesthesia and critical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic. Remimazolam is partnered in multiple territories outside of Europe. In Japan, remimazolam was approved for general anesthesia in January 2020. In the U.S., a New Drug Application (NDA) for procedural sedation is under review, with a PDUFA date of 5 July 2020. In China, licensee Yichang Humanwell filed for market approval for remimazolam in procedural sedation in November 2018 and in South Korea, licensee Hana Pharm filed for market approval for remimazolam in general anesthesia in December 2019.

In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. Results of a Phase III trial in general anesthesia are expected in the second half of 2020.

PAION’s mission is to be a leading specialty pharmaceutical company in the fields of anesthesia & critical care by bringing novel products to market to benefit patients, doctors & stakeholders in healthcare.

PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).

Contact
Ralf Penner
Vice President Investor Relations/Public Relations
PAION AG
Martinstrasse 10-12
52062 Aachen – Germany
Phone +49 241 4453-152
E-mail r.penner@paion.com
www.paion.com

Disclaimer:
This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG’s management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company’s assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.


02.04.2020 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Germany
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
E-mail: info@paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1013777

 
End of News DGAP News Service

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APEIRON Biologics Initiates Phase II Clinical Trial of APN01 for Treatment of COVID-19

DGAP-News: APEIRON Biologics AG

/ Key word(s): Study

02.04.2020 / 08:00

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

APEIRON Biologics Initiates Phase II Clinical Trial of APN01
for Treatment of COVID-19

  • Regulatory approvals obtained for the treatment of 200 COVID-19 patients in Austria, Germany and Denmark; Austrian government to provide significant financial support
  • APN01 has the potential to block the infection of cells by the novel COVID-19 virus and reduce lung injury
  • APN01 was previously proven to be safe and well tolerated in Phase I and Phase II clinical trials
  • First patient expected to be dosed shortly

Vienna, Austria, 02 April 2020: APEIRON Biologics AG today announced that it has received regulatory approvals in Austria, Germany and Denmark to initiate a Phase II clinical trial of APN01 to treat COVID-19. APN01 is the recombinant form of the human angiotensin-converting enzyme 2 (rhACE2), and has the potential to block the infection of cells by the novel SARS-CoV-2 virus (COVID-19), and reduce lung injury. The Phase II trial aims to treat 200 severely infected COVID-19 patients, and the first patients are expected to be dosed shortly.

APN01 has a unique dual mode of action. APN01 imitates the human enzyme ACE2, which is used by the virus to enter cells. The virus binds to soluble ACE2/APN01, instead of ACE2 on the cell surface, which means that the virus can no longer infect the cells. At the same time, APN01 reduces the harmful inflammatory reactions in the lungs and protects against acute lung injury (ALI/acute respiratory distress syndrome (ARDS).

“Based on its unique dual mechanism of action, APN01 has the potential to be the first drug approved to treat COVID-19 that specifically targets the new SARS-CoV-2 virus,” said Peter Llewellyn-Davies, Chief Executive Officer of APEIRON Biologics AG. “We look forward to dosing the first patient in our Phase II trial shortly, with the goal of providing a safe and effective treatment option for severely infected COVID-19 patients in urgent need of help. We are grateful to the regulatory authorities in Austria, Germany and Denmark for rapidly approving this study, and for the commitment of the Austrian Government, which has agreed to fund a significant portion of this trial.”

The randomized, double-blind Phase II trial will compare APN01 to placebo in up to 200 patients at 10 sites in Austria, Denmark and Germany. The primary objective of the trial is to assess the clinical efficacy and safety of APN01 in severe COVID-19 patients using, among other criteria, the need for invasive mechanical ventilation. Secondary objectives include the evaluation of measurable biological biomarker changes following treatment with APN01.

APN01 has been shown to be safe and well-tolerated in a total of 89 healthy volunteers and patients with pulmonary arterial hypertension (PAH) and ALI/ARDS in previously completed Phase I and Phase II clinical trials. The product candidate is currently in Phase II development by APEIRON Biologics for the treatment of PAH and ALI/ARDS, which is a significant cause of COVID-19-related mortalities.

“Importantly, the novel coronavirus strain SARS-CoV-2 is a very close relative of the first SARS-CoV virus, which emerged globally in 2002, as it critically relies on the ACE2 receptor to infect the human cell,” explained Prof. Josef Penninger, MD, co-inventor of APN01, founder of APEIRON Biologics AG, member of its supervisory board and Professor at the University of British Columbia. “There is significant scientific evidence suggesting that treatment with the dual action recombinant human ACE2 can be used to treat patients with COVID-19. We are blocking the door for the virus and, at the same time, protecting tissues, which is what ACE2 normally does.”

“We are eager to participate in this very promising and critical study. APN01 is an advanced drug candidate with a very strong dual rationale that may provide an important therapeutic contribution to fight the COVID-19 pandemic,” said Prof. Henning Bundgaard, principal investigator of the study and professor at the Faculty of Health and Medical Sciences at the University of Copenhagen.

The following centers, among others, will participate in the clinical trial: in Germany, the University Medical Center Hamburg-Eppendorf and the Klinikum rechts der Isar of the Technical University of Munich; in Austria, the Medical University of Vienna, the Kaiser Franz-Josef-Spital, Vienna, the Medical University of Innsbruck and the University Medical Center Salzburg; in Denmark, the National University Hospital, Rigshospitalet (Copenhagen), the Herlev Gentofte Hospital, the Hvidovre Hospital, and the Nordsjællands Hospital (Hillerød).

CTC North GmbH & Co. KG, a medical contract research organization at the University Medical Center Hamburg-Eppendorf, will be responsible for the study-specific organization of the clinical trial.

About APN01
APN01 is a recombinant human Angiotensin Converting Enzyme 2 (rhACE2) and was developed by APEIRON biologics for the treatment of acute lung injury (ALI), acute respiratory distress syndrome (ARDS) and pulmonary arterial hypertension (PAH). After licensing from APEIRON in February 2010, GlaxoSmithKline (GSK) conducted several clinical trials from 2014 to 2017 to treat ALI/ARDS and PAH patients, lung injury being the major source of Covid-2019 mortalities, the disease caused by the new corona virus SARS-CoV-2. In 2019, APEIRON obtained the APN01 licenses back from GSK for further clinical development, after a their strategic refocusing of GSK to oncology.

The ACE2 receptor is expressed in human airway epithelia as well as lung parenchyma and was previously identified as the essential gateway used by the first SARS-CoV virus to infect human cells. ACE2 is also the critical receptor for the new virus SARS-CoV-2 to enter human cells. Thus, treatment with recombinant human ACE2 could be used to not only block viremia but also protect lungs and other organs from injury. The drug candidate is administered intravenously as an infusion and has already shown safety and tolerability in 89 patients and volunteers.

About APEIRON Biologics AG
APEIRON Biologics is a privately-held European biotech company based in Vienna, Austria, focused on the discovery and development of novel cancer immunotherapies and respiratory diseases. APEIRON received EU marketing approval for APN311 (Dinutuximab beta, Qarziba(R)) in 2017 for the treatment of pediatric neuroblastoma patients and out-licensed global, exclusive rights for this product to EUSA Pharma Ltd. APEIRON now leverages its proprietary master checkpoint blockade mechanism to enable the human body’s natural defense mechanisms to fight the tumor. APEIRON’s clinical program APN401 is a first-in-class autologous cellular therapy to strengthen immune reactivity via an intracellular master checkpoint, Cbl-b. APEIRON’s APN01 (rhACE2) is starting a Phase II trial in Europe to treat COVID-19. APEIRON’s projects and technologies are bolstered by a strong patent portfolio. APEIRON’s development expertise is validated through partnerships with leading pharmaceutical companies and academic institutions.

For further information please contact:

APEIRON Biologics AG
Peter Llewellyn-Davies
CEO
Email: apeiron@apeiron-biologics.com
www.apeiron-biologics.com

Media and Investor Relations
MC Services AG
Julia Hofmann
T +49 89 210 228 0
Email: apeiron@mc-services.eu

FORWARD LOOKING STATEMENTS
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of APEIRON as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.


02.04.2020 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


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EVOTEC EXPANDS ITS IPSC-BASED CELL THERAPY PLATFORM EVOCELLS THROUGH LICENSING AGREEMENT WITH PANCELLA

DGAP-News: Evotec SE

/ Key word(s): Miscellaneous

02.04.2020 / 07:30

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

  • EVOTEC LICENSES PANCELLA’S STATE-OF-THE-ART IPSC TECHNOLOGIES IACT STEALTH CELL(TM) AND FAILSAFE(TM) FOR USE IN CELL THERAPY
  • ACCESS TO PANCELLA’S TECHNOLOGY HAS THE POTENTIAL TO ENABLE SAFE AND OFF-THE-SHELF CELL THERAPY PRODUCTS AND LIFTS EVOTEC’S IPSC-BASED CELL THERAPY PLATFORM (“EVOCELLS”) TO THE NEXT LEVEL
  • EVOTEC TAKES MINORITY SHAREHOLDING IN PANCELLA

Hamburg, Germany, and Toronto, Canada, 02 April 2020: Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) and the innovative biotechnology company panCELLa Inc. announced today that the companies have entered into a licensing and investment agreement.

Under the terms of the agreement, Evotec will receive a non-exclusive licence to access panCELLa’s proprietary iPS cell lines “iACT Stealth Cells(TM)”, which are genetically modified to prevent immune rejection of derived cell therapy products (“cloaking”). Furthermore, Evotec will also have access to a new-generation cloaking technology known as hypoimmunogenic cells. In addition, the “FailSafe(TM)” mechanism effectively addresses a key challenge in iPSC-based cell therapy, potential tumour formation by residual undifferentiated cells.

Using the cell lines, Evotec will be able to develop iPSC-based, off-the-shelf cell therapies with long-lasting efficacy that can be safely administered to a broad population of patients without the use of medication to supress the patients’ immune system. With a growing portfolio of iPSC-based cell therapy projects at Evotec, access to research as well as GMP-grade iPSC lines modified with one or both of the panCELLa technologies significantly accelerates Evotec’s cell therapy discovery and development efforts. Modified iPSC lines will be available for the development of cell therapy approaches across a broad range of indications by Evotec and potential partners. Furthermore, Evotec has made an investment to take a minority stake in panCELLa and has nominated Dr Andreas Scheel to join panCELLa’s supervisory board.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “Cell therapies hold enormous potential as truly regenerative or curative approaches for a broad range of different diseases with significant medical need. Integrating panCELLa’s technology and cell lines into our ongoing proprietary research and development efforts strengthens Evotec’s position in cell therapy. It is our goal to provide safe highly-effective cell therapy products to as many patients as possible. In addition to small molecules and biologics, cell therapy will become yet another major pillar of Evotec’s multimodality discovery and development platform.”

Mahendra Rao, MD, PhD, CEO at panCELLa, added: “We welcome the partnership with Evotec. Evotec’s widely recognised expertise and existing portfolio of iPSC-related technology platforms will allow panCELLa to rapidly advance its own therapeutic interests in NK cell therapy, pancreatic islet production and iPSC-derived MSC platform, in addition to enabling panCELLa to make its platform technologies widely available. I believe that the investment by Evotec in our company is a strong validation of the leading role of panCELLa in the field of regenerative medicine and in the utility of its platform technologies. We welcome Dr Andreas Scheel to our Board.”

No financial details of the agreement were disclosed.

About Evotec and iPSC
Induced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanaka’s lab in Kyoto, Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John Gurdon “for the discovery that mature cells can be reprogrammed to become pluripotent”. Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.

Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotec’s iPSC platform has been developed over the last years with the goal to industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Company’s proprietary EVOcells platform.

About cell therapy and panCELLa’s FailSafe(TM) iPSC technology
Cell therapy, one of the most promising regenerative medicine approaches, replaces a patient’s missing or broken cells with functioning cells from a range of different sources, either from a donor, from the patient’s own material, or from stem cells. The advent of induced pluripotent stem cells (“iPSC”) has opened up stem cells as an almost unlimited source of consistent-quality material for such cell therapies. At the same time, differentiating cell therapies from a single validated source circumvents critical risks of contamination associated with administering both donor and patient cell material.

However, the patient’s immune system will treat such iPSC-based transplants as “foreign” and use the body’s immune system to counteract the therapy, thus undermining its long-term efficacy. While organ transplants require an often lifelong regimen of immunosuppressants, iPSC-derived cells used for cell therapies can be cloaked to make them undetectable by the patient’s immune system, thus avoiding rejection and enabling effective long-term relief of the patient’s symptoms.

To increase the safety of such iPSC-derived cell products, panCELLa’s proprietary FailSafe(TM) technology is able to inactivate any iPSC-derived proliferating cell before and after transplantation through the use of a readily available anti-infective medication. FailSafe(TM) is the only quantifiable “safety switch” on the market which is expected to be critical for regulators, clinicians and patients to make informed decisions when evaluating treatment options.

ABOUT PANCELLA INC.
Incorporated in August 2015, panCELLa (www.pancella.com
) was founded by Dr Andras Nagy and Dr Armand Keating based on Dr Nagy’s ground-breaking work in the area of stem cell research. Through panCELLa, Drs Keating and Nagy are seeking to create an effective cell therapy derived from stem cells, which are modified to provide a sufficient and very high level of safety before and after the cells are introduced to the patient. panCELLa serves those companies developing products from stem cells. panCELLa seeks to create universal “off the shelf” FailSafe(TM) Cells and to assist pharmaceutical and biotechnology sectors to achieve such with their own cell lines. Targeted medical applications include deadly, debilitating, or aggressive diseases requiring immediate treatment where there is no time to cultivate a customized stem cell treatment from the patient (i.e. cancer, cardiac infarct, diabetes, stroke and spinal cord injury).

ABOUT EVOTEC SE
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,000 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry’s need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women’s health. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to
www.evotec.com and follow us on Twitter @Evotec.

FORWARD LOOKING STATEMENTS
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

Contact Evotec SE:
Gabriele Hansen, SVP Corporate Communications, Marketing & Investor Relations, Phone: +49.(0)40.56081-255, gabriele.hansen@evotec.com


02.04.2020 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: Evotec SE
Manfred Eigen Campus / Essener Bogen 7
22419 Hamburg
Germany
Phone: +49 (0)40 560 81-0
Fax: +49 (0)40 560 81-222
E-mail: info@evotec.com
Internet: www.evotec.com
ISIN: DE0005664809
WKN: 566480
Indices: MDAX, TecDAX
Listed: Regulated Market in Berlin, Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1013523

 
End of News DGAP News Service

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Zur Rose Group AG publishes invitation to the Annual General Meeting on 23 April 2020

EQS Group-News: Zur Rose Group AG

/ Key word(s): AGMEGM

02.04.2020 / 06:45

Press release

Zur Rose Group AG publishes invitation to the Annual General Meeting on 23 April 2020

Zur Rose Group AG today has published the invitation to the Annual General Meeting on 23 April 2020. As a result of the extraordinary situation related to the COVID-19 pandemic, this year’s Annual General Meeting will be held in accordance with the Ordinance of the Federal Council on Measures to Combat the Coronavirus. Given the measures currently in force, the personal attendance of shareholders at the Annual General Meeting on site will not be possible. Shareholders may only be represented by the independent voting rights representative. The Board of Directors regrets not being able to welcome the shareholders to the Annual General Meeting this year and requests the shareholders to make use of the option to be represented by the independent voting rights representative.

In addition to the standard agenda items of the Annual General Meeting, a proposal for creation of authorized share capital with a nominal value of CHF 39,329,880 as well as a proposal for the creation of additional conditional share capital for financing, acquisitions and other purposes pursuant to which 1,310,996 fully paid up registered shares can be issued are on the agenda of this year’s Annual General Meeting. The existing authorized capital in the Articles of Association expired on 19 June 2019. The Board of Directors is proposing to create again authorized capital in order to maintain the financial flexibility of Zur Rose Group AG. The authorized capital proposed is equivalent to 15 percent of the registered share capital of the company, which is in line with comparable companies.

In connection with the placement on March 26, 2020 of CHF 175 million convertible bonds due 2025, the available existing conditional capital of the company will be largely used up. To maintain the financial flexibility of the Company the Board of Directors proposes creating additional conditional capital for financing, acquisitions and other purposes pursuant to which 1,310,996 registered shares can be issued. The proposed conditional capital corresponds to 15 percent of the registered share capital of the company, which is in line with comparable companies.

By proposing the simultaneous creation of authorized capital and conditional capital, the Board of Directors wishes to ensure that it has the flexibility to use the appropriate financing instrument in each case. At the same time, the total number of shares that can be issued from authorized and conditional share capital shall be limited to 15 percent of the currently registered share capital (corresponding to 1,310,996 registered shares). Consequently, the Board of Directors proposes the creation of a new provision in the Articles of Association pursuant to which the total number of shares which may be issued from (i) authorized share capital where the preemptive rights were restricted or excluded and from (ii) the new conditional capital for financing, acquisitions and other purposes where the advance subscription rights were restricted or excluded will be limited to 1,310,996 registered shares.

The invitation to the Annual General Meeting of Zur Rose Group AG with the full agenda, proposals and explanations of the Board of Directors plus further information is available at www.zurrosegroup.com | Investors & Media | General Meeting or at the following link https://www.zurrosegroup.com/websites/zurrosegroup/English/2070/general-meeting-of-shareholders.html

The voting results will be published by press release and at www.zurrosegroup.com/en, “Investors & Media”, “Press Releases” shortly after the Annual General Meeting.

Investors and analyst contact
Marcel Ziwica, Chief Financial Officer
Email: ir@zurrose.com, phone: +41 58 810 11 49

Media contact
Lisa Lüthi, Head of Group Communications
Email: media@zurrose.com, phone: +41 52 724 08 14

Agenda
16 April 2020 First Quarter Trading Update
23 April 2020 Annual General Meeting
19 August 2020 Half-Year Results
21 October 2020 Q3 Trading Update

Zur Rose Group

The Swiss Zur Rose Group is Europe’s largest e-commerce pharmacy and one of the leading medical wholesalers in Switzerland. It also operates the leading marketplace in southern Europe for consumer health, beauty and personal care products commonly sold in pharmacies. The company is internationally present with strong brands, including Germany’s best-known pharmacy brand DocMorris. Zur Rose employs more than 1,800 people at sites in Switzerland, Germany, the Netherlands, Spain and France. In 2019 it generated revenue of CHF 1,569 million (including medpex) and has around seven million active customers in core European markets.

With its business model, the Zur Rose Group offers high-quality, safe and cost-effective pharmaceutical care. It is also characterized by the continuous further development of digital services in the field of drug management using AI-supported applications and new technology. Zur Rose is furthermore actively driving ahead its positioning as a comprehensive provider of healthcare services. By creating a digital healthcare platform – the Zur Rose ecosystem – it networks products and digital services from qualified providers. The contribution made by Zur Rose will be to take these offerings to customers and patients and to make a relevant selection. The aim is to provide people with a seamless accompaniment and empower them to manage their own health optimally using products and digital solutions.

The shares of Zur Rose Group AG are listed on the SIX Swiss Exchange (securities number 4261528, ISIN CH0042615283, ticker ROSE). For further information please see zurrosegroup.com.


End of Corporate News


Language: English
Company: Zur Rose Group AG
Walzmühlestrasse 60
8500 Frauenfeld
Switzerland
Phone: +41 52 724 08 14
Internet: www.zurrosegroup.com
ISIN: CH0042615283
Listed: SIX Swiss Exchange
EQS News ID: 1013299

 
End of News EQS Group News Service

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STRATEC GENERATES DOUBLE-DIGIT SALES AND EARNINGS GROWTH IN 2019

DGAP-News: STRATEC SE

/ Key word(s): Annual Results/Forecast

02.04.2020 / 06:55

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

STRATEC GENERATES DOUBLE-DIGIT SALES AND EARNINGS GROWTH IN 2019

– Sales up by 18.0% to € 221.6 million in 2019; at constant currency: +15.6% (2018: € 187.8 million)

– Adjusted EBIT for 2019 increases by 19.1% to € 31.2 million (2018: € 26.2 million)

– Adjusted EBIT margin for 2019 at 14.1% (2018: 13.9%)

– Numerous product launches and ongoing high level of development activity

– Outlook for 2020: High single-digit percentage sales growth at constant currency and adjusted EBIT margin of around 15% expected

Birkenfeld, April 2, 2020

STRATEC SE, Birkenfeld, Germany, (Frankfurt: SBS; Prime Standard) today announced its financial results and major events for the period from January 1, 2019 to December 31, 2019 with the publication of its 2019 Annual Report.

KEY FIGURES 1

€ 000s 2019 20182 Change Q4|2019 Q4|20182 Change
Sales 221,641 187,820 +18.0% 60,583 53,193 +13.9%
Adj. EBITDA 40,853 36,190 +12.9% 13,832 14,230 -2.8%
Adj. EBITDA margin (%) 18.4 19.3 -90 bps 22.8 26.8 -400 bps
Adj. EBIT 31,150 26,157 +19.1% 11,070 9,113 +21.5%
Adj. EBIT margin (%) 14.1 13.9 +20 bps 18.3 17.1 +120 bps
Adj. consolidated net income3 25,896 20,238 +28.0% 10,023 6,640 +50.9%
Adj. earnings per share (€)3 2.16 1.70 +27.1% 0.84 0.56 +50.0%
Earnings per share (€)3 1.34 0.93 +44.1% 0.63 0.42 +50.0%

Adj. = adjusted
bps = basis points

1 For comparison purposes, adjusted figures exclude amortization resulting from purchase price allocations in the context of acquisitions and the associated reorganization expenses, as well as other non-recurring effects.
2 Not retrospectively restated to reflect IFRS 16.
3 Results from continuing operations.

BUSINESS PERFORMANCE
Consolidated sales for fiscal year 2019 increased year-on-year by 18.0% to € 221.6 million (2018: € 187.8 million). On a constant-currency basis, this corresponds to growth of 15.6%. This positive sales performance was due to higher systems sales, and to increased sales with development and services, as well as with service parts and consumables. Systems sales were positively influenced both by new market launches and by strong call-up figures for products already established in the market. Sales with development and services were particularly driven by the achievement of major development targets, while business with service parts and consumables benefited from pleasing capacity utilization rates in the installed system base.

Adjusted EBIT grew by 19.1% to € 31.2 million in fiscal year 2019, as against € 26.2 million in the previous year. The adjusted EBIT margin stands at 14.1% and thus rose slightly compared with the previous year (2018: 13.9%). This key figure was positively influenced in particular by benefits of scale, as well as by measures introduced within the earnings improvement initiative launched in 2018. However, these positive factors were largely offset by a weaker sales and product mix compared with the previous year and by negative measurement items for stock appreciation rights (€ -1.0 million).

Given the operating earnings growth and a lower tax rate, adjusted consolidated net income from continuing operations rose by 28.0% to € 25.9 million (2018: € 20.2 million). Adjusted earnings per share from continuing operations (basic) for fiscal year 2019 amounted to € 2.16, as against € 1.70 in the previous year.

In the interests of comparability, key earnings figures have been adjusted to exclude amortization resulting from purchase price allocations in the context of acquisitions, associated reorganization expenses, and other non-recurring items. A reconciliation of the adjusted figures with those reported in the consolidated statement of comprehensive income can be found in the 2019 Annual Report also published today.

FINANCIAL GUIDANCE
Given the large numbers of products launched onto the market in recent years and its customers’ current order forecasts, STRATEC expects to generate rising sales with systems and with service parts and consumables in fiscal year 2020. By contrast, in view of the exceptionally strong previous year’s figure, not least due to the requirements of IFRS 15, STRATEC expects its sales with development and services to decrease.

In view of the aforementioned factors, STRATEC expects to generate constant-currency consolidated sales growth in a high single-digit percentage range in fiscal year 2020.

This increase in consolidated sales, and the resultant benefits of scale, should impact positively on profitability. For the 2020 financial year, STRATEC expects to generate an adjusted EBIT margin of around 15 % (2019: 14.1 %).

As the coronavirus (SARS-CoV-2) spreads, STRATEC is currently observing more volatile order behavior among some of its customers. Most recently, the company witnessed an upward trend in orders and order forecasts. Overall, however, the implications of the pandemic, including potential effects on the supply chain and any temporary interruptions in production arising as a result, currently cannot be predicted in full and have therefore not been factored into the above outlook. The same applies to current plans concerning the timing of and form in which the Annual General Meeting is held.

For 2020, STRATEC has budgeted investments in property, plant and equipment and intangible assets at around 10% to 12% of sales (previous year: 12.1%). Investments in property, plant and equipment mainly relate to the construction work still underway to significantly extend the buildings at the company’s headquarters in Birkenfeld. The building work is scheduled to be completed in the third quarter of 2020. As a result, the investment ratio is expected to decrease further in 2021.

PROJECTS AND OTHER DEVELOPMENTS
In fiscal year 2019, STRATEC’s customers launched two systems onto the European market that will be of key importance for the STRATEC Group’s future growth. Approval of these systems for the important US market is expected in 2020. One major focus will therefore be on ramping up serial production of these systems and dealing with inefficiencies customary to the initial phase.

STRATEC extended its development and deal pipeline with promising new projects once again in 2019. Group-wide development activities therefore remain at a very high level. The pipeline also includes numerous projects that are already in highly advanced stages of development. STRATEC therefore expects additional product launches in the months ahead.

DEVELOPMENT IN PERSONNEL
STRATEC significantly expanded its workforce once again in fiscal year 2019. Including personnel hired from a temporary employment agency and trainees, the STRATEC Group had a total of 1,302 employees as of December 31, 2019 (previous year: 1,228). Adjusted for the disposal of the nucleic acid purification business in early 2019, this corresponds to organic growth of 8.4% (nominal 6.0%). In light of the ongoing strong trend within the in-vitro diagnostics industry towards outsourcing the development and production of automation solutions to specialist partners such as STRATEC, the company expects to see consistent growth in its development activities in future as well. As a result, the company can also be expected to need growing numbers of highly qualified employees in the years ahead.

DIVIDEND PROPOSAL
Given the strong growth in its consolidated net income, its ongoing positive business prospects, and its solid balance sheet, STRATEC would like to enable its shareholders to participate in the company’s success with a higher dividend this year as well. Pending approval by shareholders at this year’s Annual General Meeting, the company currently intends to distribute a dividend to shareholders of € 0.84 per share (previous year: € 0.82 per share). Shareholders would thus benefit from the sixteenth consecutive dividend increase since payment of the first dividend in 2004.

2019 ANNUAL REPORT
The 2019 Annual Report of STRATEC SE has been published on the company’s website at www.stratec.com/financial_reports.

FORTHCOMING DATES
The Quarterly Statement Q1|2020 will be published on May 14, 2020.

CONFERENCE CALL AND AUDIO WEBCAST
To mark the publication of the definitive results for the 2019 financial year, we will be holding a conference call in English at 2.00 p.m. (CEST) today, Thursday, April 2, 2020.

You will receive the dial-in data (telephone number, password + individual PIN) following brief registration at the following link: www.stratec.com/registration

The conference call will also be available at the same time as an audio webcast at www.stratec.com/audiowebcast20200402 (brief registration required). Please note that no questions can be submitted via the audio webcast. Clicking this link also enables you to follow or download the slide presentation.

ABOUT STRATEC
STRATEC SE (www.stratec.com) designs and manufactures fully automated analyzer systems for its partners in the fields of clinical diagnostics and biotechnology. Furthermore, the company offers integrated laboratory software and complex consumables for diagnostic and medical applications. STRATEC covers the entire value chain – from development to design and production through to quality assurance.

The partners market the systems, software and consumables, in general together with their own reagents, as system solutions to laboratories, blood banks and research institutes around the world. STRATEC develops its products on the basis of its own patented technologies.

Shares in the company (ISIN: DE000STRA555) are traded in the Prime Standard segment of the Frankfurt Stock Exchange.

FURTHER INFORMATION IS AVAILABLE FROM:
STRATEC SE
Jan Keppeler | Investor Relations & Corporate Communications
Tel: +49 7082 7916-6515
Fax: +49 7082 7916-9190
ir@stratec.com
www.stratec.com


02.04.2020 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: STRATEC SE
Gewerbestr. 37
75217 Birkenfeld
Germany
Phone: +49 (0)7082 7916 0
Fax: +49 (0)7082 7916 999
E-mail: info@stratec.com
Internet: www.stratec.com
ISIN: DE000STRA555
WKN: STRA55
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1013337

 
End of News DGAP News Service

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Fresenius Medical Care partners with other dialysis providers to combat coronavirus pandemic in the U.S.

DGAP-News: Fresenius Medical Care AG & Co. KGaA

/ Key word(s): Miscellaneous

01.04.2020 / 09:01

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

Fresenius Medical Care North America has announced a collaboration with DaVita Inc. and other dialysis providers in response to COVID-19, which aims to support the broader kidney care community in the United States by offering isolation capacity for dialysis patients who are or may be COVID-19 positive.
 

Dialysis patients represent one of the most at-risk populations, particularly in the current difficult and rapidly evolving situation. To stay alive, they must receive treatment multiple days a week for three to four hours at a time. This presents a unique challenge for patients and their care teams when social distancing is required to reduce the risk of community spread and infection.

In this unprecedented time, Fresenius Medical Care North America is cooperating with DaVita Inc., U.S. Renal Care, American Renal Associates, Satellite Healthcare and other dialysis organizations. Together they are creating a nationwide contingency plan with a goal of helping to maintain continuity of care for dialysis patients by creating isolation cohort capacity that can be accessed by other dialysis providers.

A critical aim of this collaboration is to keep dialysis patients out of the hospital whenever possible, freeing up limited hospital resources. The companies are focused on ensuring there are enough nurses, social workers, dietitians, care technicians and available space to treat all dialysis patients, including those who are or may be infected with COVID-19, in a way that does not unnecessarily expose the hundreds of thousands of other patients who entrust them with their care.

Dialysis organizations have designated capacity in selected clinics across their national networks to create isolation units and shifts, which will treat patients who are or may be COVID-19 positive separately. This collaboration will help safeguard caregivers, conserve personal protective equipment and other important supplies, and create an environment that provides excess capacity for providers that may be overwhelmed by larger COVID-19 clusters.

Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases of which around 3.5 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,994 dialysis clinics, Fresenius Medical Care provides dialysis treatments for 345,096 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with the core business, the company focuses on expanding the range of related medical services in the field of Care Coordination. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).

For more information visit the Company’s website at www.freseniusmedicalcare.com.

Disclaimer
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA’s reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.

Contact:
Dr. Dominik Heger
Head of Investor Relations, Strategic Development & Communications I EVP
dominik.heger@fmc-ag.com
Tel. +49 6172 609 2525


01.04.2020 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: Fresenius Medical Care AG & Co. KGaA
Else-Kröner-Straße 1
61352 Bad Homburg
Germany
Phone: +49 (0) 6172- 609 2525
Fax: +49 (0) 6172- 609 2301
E-mail: ir@fmc-ag.com
Internet: www.freseniusmedicalcare.com
ISIN: DE0005785802
WKN: 578580
Indices: DAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange; NYSE, Luxembourg Stock Exchange
EQS News ID: 1010313

 
End of News DGAP News Service

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Uni-Bio Science Group Limited 2019 Annual Results Turnover Increased by 54.9% YoY to HK$209.4 million Recording EBITDA of HK$28.4 million Achieved Significant Progress towards Pipeline Product with 2 Product Launches Expected in 2020

EQS-News / 01/04/2020 / 08:00 UTC+8

 

(Stock code: 0690)

 

Uni-Bio Science Group Limited 2019 Annual Results

Turnover Increased by 54.9% YoY to HK$209.4 million

Recording EBITDA of HK$28.4 million

Achieved Significant Progress towards Pipeline Product with 2 Product Launches Expected in 2020

 

[31 March 2020Hong Kong] A fully integrated biopharmaceutical company Uni-Bio Science Group Limited (Uni-Bio Science, together with its subsidiaries referred to as the “Group”, stock code: 0690.HK), is pleased to announce its annual results for the year ended 31 December 2019 (the “Year”), as well as its comparatively figures for the year ended 31 December 2018 (“2018“).

 

Key Accomplishments in 2019

During the Year, the Group has recorded a spectrum of accomplishments both in terms of marketed products, and consolidation of the Group’s assets. The key highlights include:

 

  1. GeneTime(R) (EGF spray indicated for wound healing) recorded significant growth with turnover increase by 103.2% year-on-year (“YoY”) to approximately HK$128.0 million in 2019. This was mainly attributed to the effective adjustment in marketing strategy. The Group has initiated two new research projects in November 2019 on this product line, aiming to expand its application to new patient groups.

 

  1. The Group signed a letter of intent with Kai Ping Shi Jian Bao Zhen Tourism Development Company Limited (開平時間寶鎮旅遊發展有限公司) to co-construct and co-operate the healthcare facilities used for chronic disease management in the Greater Bay Area. The agreement is expected to directly benefit the long-term sales of the Group’s chronic disease products, especially the soon-to-be-launched rhExendin-4 (“Uni-E4”) and rhPTH (1-34) (“Uni-PTH”) used in the treatment of diabetes and osteoporosis, respectively. 

 

  1. The Group’s Uni-PTH (Teriparatide) high-precision industrialization project was approved by Zhongguancun Science Park Management Committee, showcasing its clinical significance and commercial potential. Upon approval, the Group has received the first installment of government support funds (RMB 10 million) in April 2019, which will be used to support the optimization and upgrades of the production line, the protection of independent intellectual property rights and major core technologies, as well as market promotion in order to prepare for its official launch.

 

  1. The Group had successfully completed a private placement of HK$30 million of new shares to a new strategic investor – CHMT Peaceful Development Fund Management Limited, which is a multi-strategy fund with worldwide investments in both private and public markets with an asset under management (AUM) of more than USD 5 billion. The proceeds from the placement will be used as the initial capital to progress three new corporate development projects towards the next stage, with hopes to further strengthen the Group’s portfolio coverage.

 

  1. Triazole, recombinant human epidermal growth factor, along with glinides class products of the Group, were once again included in the National Medical Insurance Catalogue in 2019. This has further demonstrated that the market potential of the major products sold by the Group, namely GeneTime(R) (a patented biopharmaceutical recombinant human epidermal growth factor external solution (I)), Pinup(R) (Voriconazole Tablet, a patented chemical) and Bokangtai(R) (Mitiglinide calcium tablets). The Group is expecting a significant and sustainable growth of the above products in the near future.

 

  1. The Group has completed all consistency assessment experiences for Pinup(R) (Voriconazole oral tablet), a major drug for the treatment of severe fungal infections. Documents has been submitted to the National Medical Products Administration (“NMPA”) in August 2019. The Group expects to obtain the consistency assessment certification in the second half of 2020. By completing the consistency assessment, the Group will be in a good position to enter into the centralized drug procurement list and compete against peers who have also passed the consistency assessment.

 

 

  1. Uni-PTH, the only anabolic agent effective in improving bone density and reducing the chance of vertebral and hip fractures, is getting a step closer towards its official launch. In December 2019, the Group submitted supplementary drug information to the Center for Drug Evaluation (“CDE”), and the Uni-PTH lyophilized powder injection was expected to be launched in the second half of 2020 after obtaining the drug registration approval.

 

  1. The NMPA has officially accepted the Group’s application for registering Boshutai(R) (Acarbose tablet) as a Category IV chemical drugs in January 2019. The Group is now preparing the submission of supplementary information and expects to obtain the drug registration approval number in the second half of 2020. To enhance competitive advantages, the Group further optimize its cost structure through internal control and external partnership, as the leaner cost structure should in turn offer the Group better positions in market penetration to boost marketing share with limited marketing input.

 

  1. Uni-E4, an innovative biologic drug self-developed by the Group, is a class of anti-diabetic treatments called GLP-1 agonists and a non-insulin treatment candidate that stimulates the incretin pathway. It is the first fully biologically expressed GLP-1 agent in the world. With its unique biological expression manufacturing process along with its advantages in costs and price, Uni-E4 has the potential of becoming a leading competitor of the GLP1 drugs in the blue ocean market of China. The project is currently under development as scheduled. The CDE has accepted the Group’s application for bridging trial of the new Uni-E4 pen injection formulation in December 2019. The Group expects the bridging clinical research of the Uni-E4 injection to begin in 2020, and the drug will be launched after the completion of registration with the NMPA as soon as 2022.

 

Annual Results

In 2019, the Group recorded a turnover of HK$209.4 million, representing a surge of approximately 54.9% YoY (2018: HK$135.3 million). The increase in turnover was mainly attributable to the significant sales growth of GeneTime(R) and the rebound in sales of Pinup(R). Among all the products, GeneTime(R) was particularly favoured by the market, with an increase of 103.2% from approximately HK$63.0 million in 2018 to HK$128 million in 2019. GeneSoft(R) recorded a stable revenue growth from approximately HK$27.1 million to HK$30 million, representing an increase of 10.7%. The growth was mainly attributable to our strategic cooperation with CR Zizhu to broaden our distribution channels. With new strategy in place and good progress of the bioequivalent (“BE”) study, Pinup(R) revenue surged by 58.2% from approximately HK$29.4 million to approximately HK$46.5 million in 2019. The Group expects that Pinup(R) will be the second BE approved voriconazole in the market.

 

Cost of sales for the Year increased proportionally by 58.2% from HK$17.7 million in 2018 to HK$27.9 million in 2019. Gross profit increased 54.3% from approximately HK$117.6 million in 2018 to HK$181.5 million in 2019, mainly driven by the increase in revenue. On the contrary, gross profit margin remained stable at 86.7% (2018: 86.9%). Alongside our efforts of restructuring and reorganizing our direct sales team to achieve greater efficiency, selling and distribution costs as a percentage to revenue decreased from 85.8% in 2018 to 71.3% in 2019, representing a decrease of 14.5 percentage points. The Group’s structure has changed from a divisional organization structure to a functional organization structure with specific business units, which led to additional savings and efficiencies by combining supporting functions into one. Substantial saving has been seen from such restructuring with general and administrative expenses decreased by 20.6% from HK$74.8 million in 2018 to HK$59.4 million in 2019. The Group continued to focus on research and development by investing HK$42.7 million in 2019, which was approximately the same as HK$44.2 million in 2018. With the strong revenue growth and stringent cost and expenses control measures, the Group achieved profitability this year, demonstrating the effectiveness of the our strategies. As compared with the loss of approximately HK$107.9 million for the year ended 31 December 2018, the Group recorded an earnings before interest, tax, depreciation and amortization of approximately HK$28.4 million as at 31 December 2019. Profit for the year amounted to HK$2.5 million with basic earnings per share of HK$0.04 cents, marking a turnaround from a loss of HK$138.6 million or a basic loss per share of HK2.24 cents in 2018.

 

Prospects

China’s pharmaceutical market has been growing in recent years and is estimated to reach $161.8 billion in size by 2023, or 30% of the global market. The industry has slowly shifted its focus from generic drugs to the development of original and innovative treatment. To reduce the reliance on imports, the Central Government has introduced a series of policies, some of which included developing multinational clinical centres, sharing clinical data globally, accelerating the approval process of innovative medicine, and enhancing the protection of clinical data. The drug approval speed has since increased by 62%, while the newly approved biologicals in 2018 have also surged by 450% YoY.

 

The State Council introduced a new arrangement for the state-organized, centralized procurement reform (“4+7 pilot programme“). This included expanding the pilot area for the centralized procurement and use of generic drugs to almost the entire mainland, covering 11 major cities including Shanghai and Beijing, as well as increasing the drug varieties. It is expected that in the next 3 years, 80% of the top selling drugs (oral intake) will be included in the 4+7 pilot programme. Acarbose has already been included in the list and there is a possibility that Pinup(R) may also be included within the next 3 years.

 

Mr. Kingsley Leung, Chairman of Uni-Bio Science, commented, Adhering to our strategic plan, in 2019, the Group has invested heavily on the research and development of medicines in areas of chronic metabolic disorder, such as diabetes and osteoporosis, as well as epidermal growth factors. In face of the growing ageing population, we collaborated with Kai Ping Shi Jian Bao Zhen Tourism Development Company Limited to co-construct healthcare facilities to treat the increasing needs of patients with chronic disease. We believe that this cooperation will greatly benefit our Uni-E4 and Uni-PTH development and further enhance our technical knowledge in the field of diabetes and osteoporosis. The positive feedback received from CDE and NMPA has ensured our pipeline products will be launched as scheduled and has solidified our competition advantages in the market. In response to the 4+7 pilot programme, we are actively looking for strategic partners, particularly on our generic product line in order to optimize manufacturing cost and yield a higher competitive advantage for our products. In the short term, we remain razor focused in pushing forward our drug application process, establishing strategic partnerships, as well as further optimizing our sales and marketing structure. In the mid-to-long term, we will leverage on our core strength of innovative biologic R&D, in particular look towards building a pipeline of best-in-class candidates, and less focused on generics, in hope to create a fruitful return for our shareholders.”

 

END-

 

 

About Uni-Bio Science Group Limited

Uni-Bio Science Group Limited is principally engaged in the research and development, manufacture and distribution of pharmaceutical products. The research and development centre is fully equipped with a complete system for the development of genetically-engineered products with a pilot plant test base which is in line with NMPA requirements. The Group also has two GMP manufacturing bases in Beijing and Shenzhen. The Group is focused on the development of novel treatments and innovative drugs addressing the therapeutic areas of diabetes, ophthalmology and dermatology.

 

Uni-Bio Science Group Limited was listed on the Main Board of the Hong Kong Stock Exchange on November 12, 2001. Stock code: 0690.

 

This press release is issued by DLK Advisory Limited for and on behalf of Uni-Bio Science Group Limited.

 

For further information, please contact:

 

Company Secretary : Richard She (Shen Zhen)
Tel: +86 0755 2137 6600
Email: Richard.she@unibio-science.com

 

IR: Henry Leung (Hong Kong ) 
Tel: +852 3102 0233

Email:henry.leung@unbio-science.com
http://www.uni-bioscience.com/

Document: https://eqs-cockpit.com/c/fncls.ssp?u=LFIPXKYNLO
Document title: Uni-Bio Science Group Limited 2019 Annual Results Turnover Increased by 54.9% YoY to HK$209.4 million Recording EBITDA of HK$28.4 million Achieved Significant Progress towards Pipeline Product with 2 Product Launches Expected in 2020

01/04/2020 Dissemination of a Marketing Press Release, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.

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Geratherm Medical AG: Geratherm Medical report preliminary (unaudited) 2019 business figures

Geratherm Medical AG / Key word(s): Preliminary Results

Geratherm Medical AG: Geratherm Medical report preliminary (unaudited) 2019 business figures

31-March-2020 / 17:11 CET/CEST

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

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


Publication of an insider information pursuant to article 17 of MAR
transmitted by DGAP – a service of EQS Group AG

Geratherm Medical report preliminary (unaudited) 2019 business figures

– Sales 19.9 million EUR -7.8 %

– EBITDA 2,577 k EUR -8.0 %

– EBIT 1,273 k EUR -36.0 %

– EAT 546 k EUR -52.7 %

– Result per share 11 cents

– Dividend proposal 25 cents per unit share

– Conversion of sales of apoplex medical to the entire contract term (IFRS delimitation) results in one-off strain in sales (-205 k EUR) and impact on earnings (-568 k EUR, incl. deferred tax burden amounting to 314 k EUR)

– Strong sales and earnings growth expected for 2020

Geratal, March 31, 2020 – Geratherm Medical record for the 2019 fiscal year a drop in sales of -7.8 % to 19.9 million EUR on a consolidated basis. The Healthcare Diagnostic core business (66.0 % of the group sales) could report a solid growth of + 5.1 %. The one-off special charges were due to apoplex medical, where the present sales had to be delimited according to IFRS over the entire term of the hospital contracts concluded. The one-off effect led to a decline in sales of 205 k EUR and an impact on earnings of 568 k EUR, of which 313 k EUR are for the passive deferred tax liabilities for development services. Due to product conversions, the LMT Medical subsidiary showed postponements of orders to the 2020 fiscal year resulting in a decline in sales of 1,409 k EUR and an impact on earnings of 467 EUR on group level.

The 2019 special charges should not occur again in this form for the 2020 fiscal year. Due to the Corona pandemic, Geratherm Medical had a strong start into the new fiscal year. The clinical thermometer production is being increased by 30 %. At present the demand cannot be satisfied. There is evidence that the pulmonary function of patients after a hospital stay due to Corona could be limited. Geratherm Respiratory sell pulmonary function measuring instruments for diagnosing late effects. In the first quarter the sales rose by 30 %. At present there is an increased number of incoming orders from China. We can expect that other countries will follow. The new factory building in Bad Kissingen provides the respective production capacities.

Geratherm Medical expect significantly higher reported sales and earnings for the 2020 fiscal year.

The detailed annual report will be published on April 23, 2020.

Geratherm Medical AG
Firmensitz: Fahrenheitstraße 1, 99331 Geratal
Registergericht: Amtsgericht Jena, HRB 111272
Vorstand: Dr. Gert Frank
Aufsichtsratsvorsitzender: Dipl.-Kfm. Rudolf Bröcker
Tel. 036205/98 0
E-Mail: info@geratherm.com
www.geratherm.com

Short company profil:
Geratherm Medical is an internationally operating medical products enterprise with the business areas Healthcare Diagnostic, Medical Warming Systems, Cardio/Stroke and Respiratory. Our company’s roots are in temperature measurement in the medical sphere. In this business area we offer a broad spectrum of products, most of which have unique selling points. We supply our customers/patients with high-quality products ranging from thermometers to complex warming systems for use in the operating theatre and by emergency rescue services and MR Diagnostic Incubator Systems for premature babies and newborns. In the Cardio business area we concentrate on the development of products for the detection of atrial fibrillation as a measure to prevent strokes. The Respiratory segment develops and markets products for the assessment of pulmonary function. In all mainly business areas, Geratherm has patent-protected basic technologies at its disposal. We regard ourselves as a research-based medical products company with a clear focus on medical diagnostic devices that generate vital data. Geratherm shares have been listed in the Prime Standard segment of the Frankfurt Stock Exchange since the year 2000. Geratherm Medical continues to be represented in the German Entrepreneurial Index and in the German Healthcare Index.

 

 

 

Contact:
Dr. Gert Frank


31-March-2020 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de


Language: English
Company: Geratherm Medical AG
Fahrenheitstraße 1
98716 Geschwenda
Germany
Phone: +49 (0)36205 98-0
Fax: +49 (0)36205 98-1 15
E-mail: info@geratherm.com
Internet: www.geratherm.com
ISIN: DE0005495626
WKN: 549562
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1012147

 
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