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March 6, 2024 Newswires
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Germany Pharmaceuticals 6 Mar 24 – INDUSTRY SNAPSHOTS

Acquisdata Industry Snapshot
LATEST COMPANY NEWS

BNN Breaking - C4 Therapeutics and Merck KGaA Forge $756M Deal on Cancer-Fighting Protein Degraders - 4/3/2024

C4 Therapeutics, Inc. (C4T) and Merck KGaA, Darmstadt, Germany, announced a landmark collaboration aimed at advancing two targeted protein degraders from C4T's discovery pipeline.

For the complete story see:

https://bnnbreaking.com/finance-nav/business/c4-therapeutics-and-merck-kgaa-forge-756m-deal-on-cancer-fighting-protein-degraders

Reuters - Bayer purchases heart drug for up to $310 mln - 4/3/2024

Bayer opens new tab said on Monday it acquired the exclusive marketing rights for Europe for a new drug that is under regulatory review to treat a rare, potentially fatal heart disease for up to $310 million upfront.

For the complete story see:

https://www.reuters.com/business/healthcare-pharmaceuticals/bayer-purchases-heart-drug-up-310-mln-2024-03-04/

CHEManager - Merck Opens New €20 Million Distribution Center in Brazil - 28/2/2024

Merck will open a new € 20 million distribution center in São Paulo, Brazil to better serve its Life Science customers in the region.

For the complete story see:

https://www.chemanager-online.com/en/news/merck-opens-new-eu20-million-distribution-center-brazil

Other Stories

Pharmaceutical Technology - Bayer wins FDA breakthrough therapy designation for NSCLC candidate - 26/2/2024

Financial Times - Boehringer Ingelheim says weight-loss drug had positive impact on liver condition - 26/2/2024

The Pharma Letter - Boehringer's dual-action GLP-1 agonist hits goals in MASH trial - 26/2/2024

BNN Breaking - Fresenius Medical Care Forecasts Robust Earnings Growth Amidst Global Dialysis Demand Surge - 20/2/2024

Yahoo News - German pharma, lab supplier Sartorius says 2023 profit fell - 16/2/2024

Media Releases

Bayer - Bayer strengthens pharma portfolio with new cardiology drug acoramidis - 4/3/2024

Bayer - Julio Triana appointed to Board of Management of Bayer AG and President of the Consumer Health Division - 29/2/2024

Merck - Merck Opens new € 20 Million Distribution Center in Brazil - 27/2/2024

Latest Research

CXCR5 is a very promising drug target for the development of antibody-drug conjugates to treat patients with lymphoma - By Tibor Schomber, Beatrix Stelte-Ludwig, Amy J. Johnson, Oliver von Ahsen, Christoph Schatz, Raquel Izumi, Ahmed Hamdy, Hans-Georg Lerchen

Industry Overview

The Pharmaceutical Industry

Overviews of Leading Companies

Aenova Group

Bayer Group (FRA: BAYN)

B. Braun Group

Boehringer Ingelheim Group

Carl Zeiss Meditec Group (FRA: AFX)

Desitin Arzneimittel GmbH

Fresenius Group (FRA: FRE)

Grünenthal GmbH

Hartmann Group (FRA: PHH2)

Merck & Co., Inc. (NYSE: MRK, XPAR: MRK)

Merz Group

MorphoSys AG (FRA: MOR, NASDAQ: MOR)

Rhön-Klinikum AG (XETR: RHK)

STADA Group

Associate: Mohammad Azhar Bin Mazlan

News and Commentary

BNN Breaking - C4 Therapeutics and Merck KGaA Forge $756M Deal on Cancer-Fighting Protein Degraders - 4/3/2024

C4 Therapeutics, Inc. (C4T) and Merck KGaA, Darmstadt, Germany, announced a landmark collaboration aimed at advancing two targeted protein degraders from C4T's discovery pipeline.

For the complete story see:

https://bnnbreaking.com/finance-nav/business/c4-therapeutics-and-merck-kgaa-forge-756m-deal-on-cancer-fighting-protein-degraders

Reuters - Bayer purchases heart drug for up to $310 mln - 4/3/2024

Bayer opens new tab said on Monday it acquired the exclusive marketing rights for Europe for a new drug that is under regulatory review to treat a rare, potentially fatal heart disease for up to $310 million upfront.

For the complete story see:

https://www.reuters.com/business/healthcare-pharmaceuticals/bayer-purchases-heart-drug-up-310-mln-2024-03-04/

CHEManager - Merck Opens New €20 Million Distribution Center in Brazil - 28/2/2024

Merck will open a new € 20 million distribution center in São Paulo, Brazil to better serve its Life Science customers in the region.

For the complete story see:

https://www.chemanager-online.com/en/news/merck-opens-new-eu20-million-distribution-center-brazil

Pharmaceutical Technology - Bayer wins FDA breakthrough therapy designation for NSCLC candidate - 26/2/2024

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Bayer for its non-small cell lung cancer (NSCLC) candidate BAY 2927088.

For the complete story see:

https://www.pharmaceutical-technology.com/news/bayer-wins-fda-breakthrough-therapy-designation-for-nsclc-candidate/

Financial Times - Boehringer Ingelheim says weight-loss drug had positive impact on liver condition - 26/2/2024

German pharma group finds no unexpected side effects during trial, including at higher doses.

For the complete story see:

https://www.ft.com/content/0a75f311-f960-4f81-9c11-00e14923ecef

The Pharma Letter - Boehringer's dual-action GLP-1 agonist hits goals in MASH trial - 26/2/2024

Germany's Boehringer Ingelheim has announced positive results from a Phase II trial of survodutide, a glucagon/GLP-1 receptor dual agonist.

For the complete story see:

https://www.thepharmaletter.com/article/boehringer-s-dual-action-glp-1-agonist-hits-goals-in-mash-trial

BNN Breaking - Fresenius Medical Care Forecasts Robust Earnings Growth Amidst Global Dialysis Demand Surge - 20/2/2024

Fresenius Medical Care, the world's largest dialysis services and technologies provider, has shown promising growth prospects.

For the complete story see:

https://bnnbreaking.com/finance-nav/fresenius-medical-care-forecasts-robust-earnings-growth-amidst-global-dialysis-demand-surge

Yahoo News - German pharma, lab supplier Sartorius says 2023 profit fell - 16/2/2024

German pharma and lab supplier Sartorius reported that fiscal 2023 profit to equity holders of Sartorius AG declined to €205.2 million ($220 million) from €678.1 million, last year.

For the complete story see:

https://news.yahoo.com/german-pharma-lab-supplier-sartorius-104150101.html

Media Releases

Bayer - Bayer strengthens pharma portfolio with new cardiology drug acoramidis - 4/3/2024

Acquisition of exclusive commercialization rights for European markets / Highly potent selective small molecule oral transthyretin stabilizer for transthyretin amyloid cardiomyopathy (ATTR CM) / Marketing authorization application already submitted to European Medicines Agency / Highly strategic fit with Bayer's cardiovascular portfolio and innovation strategy

Berlin, Germany, March 4, 2024 - Bayer has acquired the exclusive marketing rights for acoramidis in Europe from Eidos Therapeutics Inc., BridgeBio International GmbH and BridgeBio Europe B.V.. Acoramidis is a highly potent and selective small molecule, orally administered transthyretin (TTR) stabilizer for the treatment of patients suffering from ATTR CM, a progressive fatal disease presenting as an infiltrative, restrictive cardiomyopathy resulting in heart failure. In a placebo-controlled Phase III study in ATTR CM, acoramidis met all clinical endpoints by significantly reducing hospitalization burden, improved survival and preserved functional capacity and quality of life for patients in need.

Marketing authorization application (MAA) with the European Medicines Agency (EMA) was filed in January 2024, after announcing that acoramidis successfully met the primary endpoint in the pivotal Phase III trial, confirming highly statistically significant efficacy and good tolerability in the trial population. New Drug Application (NDA) for acoramidis has also been submitted to U.S. Food and Drug Administration (FDA) and accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024.

"Bayer has a clear vision to transform cardiovascular care for patients and acoramidis complements our portfolio in specialty cardiology," said Juergen Eckhardt, M.D., Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Business Development, Licensing & Open Innovation. "As a leading player in the field of cardiovascular diseases, we will work to make this new treatment available to patients as soon as possible, after a positive decision by the European authorities."

"We are excited to have found a like-minded partner in Bayer that shares our belief in the potential of acoramidis to ameliorate the lives of ATTR CM patients. We have a responsibility to the ATTR CM community to make acoramidis available to as many patients as possible, as quickly as possible, and we believe that Bayer is the right collaborator for us in this mission," said Ananth Sridhar, Senior Vice President of Corporate Development, BridgeBio Cardiorenal. "This partnership leverages Bayer's established European cardiovascular infrastructure and enables us, via substantial cost savings, to focus our resources on our wholly-owned geographies for acoramidis, including preparing for the US launch."

Under the terms of the agreement, BridgeBio and the affiliates will receive up to USD 310 million in upfront and near-term milestone payments and are eligible to receive additional undisclosed sales milestone payments and tiered-royalties beginning in the low-thirties percent.

https://www.bayer.com/media/en-us/bayer-strengthens-pharma-portfolio-with-new-cardiology-drug-acoramidis/

Bayer - Julio Triana appointed to Board of Management of Bayer AG and President of the Consumer Health Division - 29/2/2024

Leverkusen, February 29, 2024 - The Supervisory Board of Bayer AG has appointed Julio Triana (58) to Bayer's Board of Management effective April 1, 2024. He will become President of the Consumer Health Division effective May 1, 2024, and succeed Heiko Schipper (54), who has asked the Supervisory Board to bring forward the end date of his contract in order to pursue a career opportunity outside of Bayer. Schipper will leave the company effective April 30, 2024.

"We are extremely pleased to have Julio Triana join Bayer's Board of Management and assume leadership of our Consumer Health business," said Prof. Dr. Norbert Winkeljohann, Chairman of the Supervisory Board of Bayer AG. "He brings a unique combination of financial, marketing, scientific and analytical skills to business leadership. His three decades of leadership in healthcare across four continents, and his proven track record of sustainably growing businesses make him the ideal leader to expand our portfolio of everyday health solutions and realize its full potential. Julio is known for his collaborative and purpose-driven approach and for building diverse, inclusive and empowered teams and we expect him to be a major force for driving the transformation of Bayer," said Winkeljohann. "At the same time, we would like to warmly thank Heiko Schipper for his great achievements during the past six years at Bayer. He has successfully led and strategically transformed the Consumer Health Division, bringing it back to the forefront of the industry. We wish him all the very best for the future."

Julio Triana is currently Head of Commercial Operations Region International for Bayer's Pharmaceuticals Division, a member of the Division's Executive Committee as well as the Senior Bayer Representative Japan and President of Bayer Holding, Ltd. Japan. Triana is a very seasoned executive with a dynamic 30-year career in the global healthcare industry. He joined Bayer in 2002, and has held roles of increasing responsibility in Finance, Strategy, Business Development and most recently Commercial Operations, among others. Triana holds an MBA from Universidad Antonio de Nebrija (Madrid, Spain) as well as a Bachelor of Science in Biology from University of Houston (Houston, Texas, USA). He has comprehensive experience in leading and transforming large organizations across multiple functions and in different cultural contexts with a strong track record of successful market expansions, sustainable revenue growth and orchestrating complex integrations.

Triana is married with one son and in addition to his native country, Colombia, he has lived and worked in Argentina, Brazil, Spain, USA, Switzerland, Germany and Japan.

https://www.bayer.com/media/en-us/julio-triana-appointed-to-board-of-management-of-bayer-ag--and-president-of-the-consumer-health-division/

Merck - Merck Opens new € 20 Million Distribution Center in Brazil - 27/2/2024

13,000 square-meters space for Life Science business sector accommodates 11,000 pallet positions and more than 50,000 stock-keeping units

27 FEB 2024 | DARMSTADT, GERMANY

New site in Cajamar, São Paulo has 2.5 times more storage capacity than previous space in Cotia, São Paulo

13,000 square-meters space for Life Science business sector accommodates 11,000 pallet positions and more than 50,000 stock-keeping units

Employees from Cotia will move to Cajamar distribution center

Merck, a leading science and technology company, will open a new, € 20 million distribution center in Cajamar, São Paulo, Brazil to better serve its Life Science customers in the region. The new space, which will be operational in late February, has an area of 13,000 square meters - twice as large as the former location in Cotia.

According to Vinícius Andremarchi, Head of Distribution for Life Science at Merck, Brazil, the move to a larger facility supports the country's growing demand for life science products. The outskirts of São Paulo, including the capital, account for 60% of the Life Science customer demand in Brazil. The new space allows for faster deliveries in the region, in some cases, taking less than 24 hours.

"In 2023, the pharmaceutical industry and academic markets in Brazil grew by 10.5%. With that comes the demand for products and solutions offered by our Life Science business sector. The new distribution center allows us to store a more robust portfolio in an appropriate and accessible way," said Andremarchi.

The layout of the new space makes it possible to optimize workflows and has more technological equipment and automated, ergonomic workstations for employees. Other features include a 1,000m² mezzanine, laboratories, administrative rooms, employee amenities and customer reception.

The new site is closely alignment with Merck's global sustainability objectives: With a well-designed environment, the space has received the Leadership in Energy and Environmental Design (LEED) Gold level certification from the Green Building Council (GBC), the world's largest non-profit organization that steers the construction market towards more sustainable practices.

https://www.merckgroup.com/en/news/new-distribution-center-in-brazil-27-02-2024.html

Latest Research

CXCR5 is a very promising drug target for the development of antibody-drug conjugates to treat patients with lymphoma

Tibor Schomber, Beatrix Stelte-Ludwig, Amy J. Johnson, Oliver von Ahsen, Christoph Schatz, Raquel Izumi, Ahmed Hamdy, Hans-Georg Lerchen

Abstract

Introduction: The chemokine receptor CXCR5 is highly expressed in tumor cells from different lymphoma types and represents a viable drug target for the development of antibody-drug conjugates (ADC) to treat patients with lymphoma.

Methods: Immunohistochemistry of human tissues of different lymphoma types were stained using antibodies against human CXCR5, CD20, CD70 and CD79b. Slides were examined by a pathologist and scored for expression. CXCR5 expression on tumor cell lines was analyzed by flow cytometry. Cell surface receptor density was analyzed by Quantibrite ™ PE-beads. Evaluation of antibody internalization was performed using the Operetta High Content Imaging System. NOD/SCID mice were transplanted subcutaneously with lymphoma patient-derived (PDX) tumor specimens and treated with 2mg/kg or 10mg/kg VIP924 CXCR5-ADC or isotype control.

Results: CXCR5 reveals very low to no expression in most tissues except for lymph nodes. Expression of CXCR5 and other B-cell targets like CD19, CD20, CD70 and CD79b was analyzed on patient-derived tumor samples. High expression of CXCR5 was found on naïve and previously treated diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) samples. Based on these results, we developed a CXCR5 targeted ADC with a novel, highly potent kinesin spindle protein inhibitor (KSPi) payload linked via a legumain-cleavable linker (VIP924). To compare the performance of KSPi ADCs, the same effector chemistry was attached to antibodies against other B-cell targets and tested in cytotoxicity assays in various cell lines. CXCR5-targeted ADC demonstrates significantly higher activity compared to the other ADCs tested except for the CD79b ADC with equal potency. VIP924 was then tested in vivo in different PDX tumor mouse models with different levels of CXCR5 expression. In the LY2264 and HBL-1 DLBCL models, we obtained a tumor growth inhibition of 68% and 100% respectively compared to isotype control. The median survival time for the isotype control group was 29 days and median survival time for the mice treated with 10mg/kg VIP924 could not be determined as all mice survived until the end of the study (Day 37). No effect on body weight or any adverse effects in the VIP924 treated mice were observed.

Conclusions: CXCR5 is a highly attractive target in hematological malignancies such as DLBCL, MCL, and FL due to high protein expression and almost no expression in healthy tissues. CXCR5-targeting ADC with KSPi payload showed high potency and superiority to other B-cell-targeted ADCs in vitro on a broad range of lymphoma cell lines. VIP924 with a novel legumain-cleavable linker showed activity in in vivo PDX models from lymphoma patients. Due to the high CXCR5 expression found in relapsed DLBCL patients, VIP924 may bring promising new treatment options for previously treated patients with lymphoma.

Citation Format: Tibor Schomber, Beatrix Stelte-Ludwig, Amy J. Johnson, Oliver von Ahsen, Christoph Schatz, Raquel Izumi, Ahmed Hamdy, Hans-Georg Lerchen. CXCR5 is a very promising drug target for the development of antibody-drug conjugates to treat patients with lymphoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 6294.

https://aacrjournals.org/cancerres/article/83/7_Supplement/6294/721035

The Industry

INDUSTRY OVERVIEW

The Pharmaceutical Industry in Germany (Issue 2021/2022)

Germany - Europe's Largest Pharmaceutical Market

"Germany is one of the most developed healthcare markets in the world and a strategic gateway to the EU single market for international companies."

EUR 46.4 bln pharmaceutical industry revenue in 2019 - the biggest pharmaceutical market in Europe

5.1% annual revenue growth in the pharmaceutical market (pharmacies and clinics) over a five- year period (CAGR 2014-2019)

12.5% of revenue invested in R&D in 2018 - the highest rate among all major industry sectors in Germany

EUR 83.2 bln in exports of pharmaceuticals in 2018 - the world's leading exporter of medicinal products

EUR 7.4 bln R&D investments by pharmaceutical companies in Germany in 2018

83 mln population drives domestic demand for health- care products and services

Combining cutting edge innovation, a long tradition as the "world´s pharmacy" and continuously growing demand for healthcare products, Germany is the ideal location for pharmaceutical R&D, production, and sales of medicines. Driven by trends such as demographic change, a rise in chronic diseases and an increasing emphasis on prevention and self medication, Europe's biggest pharmaceutical market is growing faster than the German economy. Germany belongs to the world's leading clinical trials locations and based on R&D investment and patent application levels is the leading location for pharmaceutical innovation in Europe. Building on these competencies, many German organizations have become key contributors in the global fight against the Covid-19 pandemic.

The country is the largest exporter of medicinal products and ranks among the top pharmaceutical producers worldwide. In light of the global need for personalized medicine, Germany has also evolved into one of the main suppliers of novel biopharmaceuticals. Located in the heart of Europe and benefiting from excellent infrastructure and a highly skilled workforce, the continent's most populous country offers attractive opportunities and a favorable investment climate for pharmaceutical companies planning to expand internationally.

The Pharmaceutical Industry in Numbers

Germany's industry numbers speak for themselves and for a secure and successful investment in the country.

Europe's Biggest Market

Germany constitutes the major European pharma- ceutical market and the fourth largest worldwide after the USA, China and Japan. In 2019, revenues in the overall pharmaceutical market increased by 5.7 percent, reaching EUR 46.4 billion (ex-manufacturer prices). Approximately 86 percent of revenues were generated in the pharmacy segment, while 14 per- cent were being made in the clinic segment. During the same year, drug sales by pharmacies (including mail-order pharmacies) rose to EUR 58.8 billion (ex- pharmacy prices), corresponding to growth of 5.3 percent. Prescription-only medicines accounted for 88 percent of these sales. Whereas non-pre- scription medicines only generated 12 percent of revenue, they accounted for half of units sold.

Strong Industry Base

More than 500 pharmaceutical companies are located in Germany, including domestic corpora- tions as well as subsidiaries of international enter- prises. These range from big corporates like Bayer, Boehringer Ingelheim and Merck to small innova- tive biotechnology start-ups. As in other economic sectors, SMEs constitute the backbone of the pharmaceutical industry, with around 90 percent of manufacturers having less than 500 employees. In 2017, 234 of these companies employed fewer than 20 staff. Overall, the German pharmaceutical industry has a workforce of 120,000 people (2019).

Leading Pharmaceutical Supplier

Following its tradition as the "world's pharmacy," Germany generated production value of EUR 36.1 billion in 2018, making it the leading pharmaceuti- cal manufacturing location in the EU. Located in the heart of Europe and embedded into global supply chains, the country imported medicines worth EUR 56.9 billion in 2018, equivalent to an increase of 8.1 percent. During the same period, exports of pharmaceuticals grew by 10.3 percent reaching EUR 83.2 billion, consolidating Germany's position as the world's leading supplier of medica- tions and the second largest importer.

R&D Excellence and Innovation

Germany provides the perfect environment for the development and production of research intensive, high grade products. In 2018, the pharmaceutical industry in Germany invested almost EUR 7.4 billion in R&D more than in any other European country. The German pharmaceutical sector shows the highest research intensity across all major German industries about 12.5 percent of revenues were reinvested in R&D in 2018. With 499 clinical trials financed by research-based pharmaceutical companies in 2019, Germany ranks fifth worldwide. Based on the number of patent applications, the country is leading in pharmaceutical innovation in Europe. In 2018, some 584 patents were registered with the European Patent Office by the pharmaceutical industry in Germany.

Market Opportunities & Trends

Growing Healthcare Market

With 83 million inhabitants, Europe's most populous country also represents the biggest healthcare market in the region with expenditure continuously rising. This offers interesting opportunities for international companies operating in the market. In 2018, health expenditure in Germany reached a new high of EUR 390.6 billion, corresponding to a per capita spending of EUR 4,712. Between 2013 and 2018, the country's healthcare market grew by almost 4.4 percent per year on average. The healthcare sector currently accounts for almost 12 percent of German GDP, with the share steadily increasing as annual growth rates exceed the pace of overall domestic economic growth. Driven by developments like demographic change, the growing prevalence of chronic diseases, and the recent Covid-19 outbreak, this upwards trend in annual German health expenditure is expected to continue, after already exceeding the EUR 400 billion mark in 2019.

Demographic Change

One of the main drivers of the healthcare market is demographic change. Germany, like much of Europe, has an aging society. Birth rates remain low while life expectancy at birth continues to grow - reaching 84 years for women and 79 years for men in 2020. Today, approximately half of the German population is older than 45 years of age and about 22 percent are at least 65 years old, making it one of the world's oldest populations. Forecasts suggest that the share of the"65 plus" generation will increase to about one third of the population by 2035. This age group already accounts for around half of overall healthcare expenditure in Germany. Moreover, the number of people aged 85 or more is expected to rise to 3.3 million by 2025 - equivalent to four percent of the population. In 2019, more than 4.2 million people in Germany were in need of care. The risk of illness - and the probability of being affected by several chronic diseases - goes up as age levels rise. This leads to greater demand in the domestic healthcare sector.

Chronic Diseases

The treatment of the growing number of patients affected by (age-related) chronic and incommunicable diseases constitutes a major concern of the German healthcare system. Together, cardiovascular diseases, psychological disorders and musculoskeletal diseases account for more than one third of overall healthcare spending in Germany (36.9 percent in 2015). Chronic lung diseases, cancer and diabetes mellitus being the most common metabolic disorder - are also widespread among the general population. Estimates suggest that around six percent of German adults suffer from asthma and almost 10 percent of adults have diabetes mellitus (including around 2 million people with undetected diabetes). The German market offers attractive opportunities for pharmaceutical companies providing innovative drugs and novel, more customized therapies also for patients diagnosed with chronic diseases.

Health Insurance

Mandatory health insurance and different sources of financing contribute to solid healthcare provision including access to medicines - in Germany. Almost 88 percent of the German populations are insured by one of the more than 100 statutory health insurance companies, with around 10.5 percent of the population being privately insured. In 2018, public and private health insurers covered nearly two thirds of total healthcare spending in Germany, accounting for 56.8 and 8.5 percent respectively. The remaining amount was funded by private and public households, social long-term care insurance, employers, statutory accident insurance and the statutory pension fund. Pharmaceutical spending by statutory health insurances increased by 4.7 percent in 2019, reaching EUR 41.7 billion, whereby oncological treatments accounted for 42 percent of additional expenses. Moreover, costs were driven by growing expenses for pharmaceuticals for stroke prophylaxis and ant rheumatic drugs amongst others. During the same period, the leading indication areas in terms of statutory health insurer expenditures were antineoplastic, immunosuppressive drugs, anti- diabetics, and anticoagulants.

"Out-of-Pocket" Payments

Increasingly, patients are also paying for medicines "out-of-pocket", mainly for over-the-counter medicines and co-payments for prescribed drugs. This trend is also driven by so-called "switches", meaning that previous prescription-only medicines gain the non-prescription status. This was the case for 25 treatments between 2007 and the beginning of 2020. In the light of growing health- care expenses, self-medication and consultation provided by local pharmacies may also relieve doctors and health insurers.

Over-the-Counter (OTC) Market

Market Trends

Germany's consumer health market is enjoying constant growth thanks to an increasing focus on preventive healthcare and self-medication within German society. Following current health and wellness trends and the desire to grow older in good health, more and more Germans display growing health awareness levels and an interest in a more active and healthy lifestyle. Many consumers adopt a prevention-based attitude and are willing to invest in their health by spending money on products supporting personal wellbeing. Moreover, patients may use OTC medicines to treat relatively minor ailments including colds, sore throats and the like.

Market Segments

The German OTC market comprises two major segments: non-prescription drugs and health products. Non prescription drugs include pharmacy-only drugs as well as OTC drugs that may also be sold outside of pharmacies. Product groups that are not subject to pharmaceutical legislation for example, nutritional supplements, healing earths and seawater nasal sprays belong markets. The average annual growth rate of the German OTC market amounts to four percent for the period 2014 to 2019. In 2019, revenues increased by 3.7 percent to almost EUR 10.7 billion. More than EUR 7.2 billion was generated in the non-prescription drugs segment and over EUR 3.4 billion with health products - corresponding to a sales volume of 811 million and 744 million pack- aging units respectively. Although self-medication represents the major share of OTC sales, OTC products prescribed by physicians represent a further opportunity.

Opportunities

Remedies for the respiratory system and pain treatments account for the highest share of overall OTC sales via pharmacies (including mail order). In 2019, the vitamins and minerals seg- ment demonstrated the highest growth rate (6.8 percent), with revenue exceeding EUR 1.1 billion. After double-digit growth in previous years, sales of probiotics for the digestive tract increased by seven percent reaching EUR 163 million in 2019. In terms of sales volume, eye medicines (4.9 percent), vitamins and mineral nutrients (3.7 percent) as well as remedies for the bladder and reproductive organs (3.6 percent) recorded the strongest increase. The segment of OTC phytopharmaceuticals and homeopathic remedies accounted for 31 percent of total non-prescription drug sales by pharmacies. Future forecasts suggest a positive market development and expect OTC drug sales to grow by around three percent per year between 2019 and 2029.

Biopharmaceuticals

Increasing Market Share

The development of biological drugs has led to substantial shifts in the pharmaceutical industry landscape in recent years. Large companies have moved their focus from small molecule drugs towards the development and production of complex biological compounds that are made with the help of a variety of organisms. Because of their high therapeutic potential, biologics have taken up a considerable share of the pharmaceutical market in Germany: From 2015 to 2019, the biologics market grew by 11.6 percent on average annually - more than twice the growth of the overall pharma market. The total revenue of biopharmaceuticals in Germany is EUR 12.7 billion (2019), equivalent to more than a quarter of the market for pharmaceuticals.

Market penetration has been steadily increasing in recent years, but differs according to therapeutic area. Biopharmaceuticals generate 80 percent of immunology sales, whereas the figure is as low as three percent for cardiovascular indications. Biopharmaceutical sales in oncology grew by 23 percent in 2019, but the highest growth rate was recorded by anti-infective with an increase of 40 percent.

Development Pipeline

The growing importance of biopharmaceuticals is also reflected in the development pipeline. As of 2019, companies active in pharma R&D in Germany were developing 640 biologics in clinical development 82 percent of phase III assets were new biological entities. Gene therapies experienced the fastest increase, with an average growth of over 10 percent per year since 2015. Key areas of biologics development are oncology, immunology and infectious diseases. In the last three years, biopharmaceuticals accounted for more than half of all drug approvals in the European Union.

Biosimilars

As innovative biological drug patents expire, more pharma companies have the opportunity to manufacture and commercialize the compound - a key factor in pharma market dynamics in recent years. Germany has shown its strength as a world- class manufacturing location and is now one of the global biopharma production centers. Most of the biologicals recently developed are antibodies that need to be produced in larger quantities than the first-wave biologics which hit the market in the previous decades. Due to the challenges that this trend creates for the industry, biopharma manufacturing will continue to be a demanding activity that requires suitable expertise and infrastructure - making Germany a prime location in this field. In 2019, pharma companies active in Germany were developing 20 biosimilar products in phase III alone. From 2007 to 2019, biosimilars sales achieved a CAGR of 69 percent.

Pharma Manufacturing

Major Production Location

Germany is one of the world's top locations for pharmaceutical production. In 2018, pharmaceutical production volume reached EUR 36 billion equivalent to 18 percent year-on-year growth. According to EFPIA, Germany is the biggest pharmaceutical manufacturing location within the European Union and ranks second in Europe after Switzerland. In the field of biopharmaceutical production, Germany has the second highest figures worldwide after the USA. Two important factors contributing to this excellent position are the high-performing industrial infrastructure and the long-standing strength of the local chemical industry. Between 2010 and 2019, pharmaceutical manufacturers in Germany recorded an increase in the gross value added by 17 percent. In 2017, the gross value added in the pharmaceutical sector was over EUR 135 thousand per employee.

Contract Manufacturing Organizations

Germany is also home to outstanding contract manufacturers. International and national clients can easily obtain any service they require - from initial product idea to final product - at moderate cost. Boehringer Ingelheim, for example, is the only company in the world that is active across the entire biopharmaceutical process chain. This enables faster timelines and simpler coordination of processes worldwide. The Federal Ministry for Economic Affairs and Energy's "Health Made in Germany" initiative can help along with GTAI to identify possible partners. Its "German Biomanufacturing Guide" provides a comprehensive over- view of active in Germany.

High Production Standards

Germany is an ideal production location for research-intensive, high-grade products. It places a high value on technology; this stemming from the country's long history of developing and manufacturing high-quality pharmaceutical products. The country's particular strength lies in producing complex products where containment and sterile environments are critical. Hundreds of thousands of highly skilled employees in medical-technical, pharmaceutical-technical and engineering back- grounds enable companies to utilize efficient and complex production processes. Contractual agreements are secure and foreign patent holders are equally well protected as Germans.

Investment and Trade

The investment activity of pharmaceutical companies in Germany has been experiencing a steady increase in recent years. Most of the investments were aimed at capacity increases, which underline the confidence of the local companies in sustained growth. In the course of the global effort to tackle the Covid-19 pandemic, calls for a reinvigoration of small molecule drug and API manufacturing have been increasingly heard. The economic stimulus package passed in June 2020 dedicates EUR 1 billion to this objective. This measure aims to reduce the dependency on global supply chains and is expected to trigger substantial investments in the German pharmaceutical production sector in the near future. The strong export orientation of the German pharmaceutical industry shows its competitiveness: In 2018, about two thirds of its sales were generated abroad. The export volume of pharmaceuticals has been growing continuously since 2012 by 7.4 percent on average annually.

Research Excellence

Research Landscape

Over 30 biotechnology clusters contribute substantially to the advancement of pharmaceutical innovation by bundling scientific expertise as well as connecting academic and industrial players in the field of drug development. In addition to the over 400 universities in Germany, numerous specialized research institutes - including the Fraunhofer Society, the Max-Planck-Society, the Helmholtz Centres and the Leibniz Association - conduct world-class fundamental and applied scientific research. In total, there are over 1,000 publicly financed research institutions and more than 500 pharmaceutical companies in Germany, creating an innovation ecosystem that enjoys global acclaim.

The Federal Ministry for Education and Research has proclaimed the next ten years as the "National decade against cancer" and correspondingly launched initiatives to prioritize oncology research over the coming years. The federal "High-tech Strategy 2025" also identifies infectious diseases as a focal point of activity over the next years.

Innovation Ecosystem

In order to foster the translation of research out- comes into successful products, the Go-BIO pro- gram supports biotechnology start-ups in bringing their inventions to market. Since 2005, 58 newly established biotech companies have received support to grow into sustainable businesses. The Life Science Incubator (LSI) in Bonn and Dresden also helps scientists to bridge the critical gap between a good idea and the proof of concept, making further financing opportunities available. Moreover, the LSI supports academics with out- standing business ideas by providing them with the entrepreneurship expertise required for their value proposition to take off.

Over 15 start-up centers specifically dedicated to fostering emerging biotech/life science companies can be found all over Germany. They provide lab infrastructure and a supportive environment for biotech entrepreneurs to bring their ideas to market.

Industry Research

The pharmaceutical industry is known for its high R&D intensity - and Germany is no exception. In 2018, around 12.5 percent of revenues were reinvested in R&D the highest rate among all major industry sectors in Germany. Approximately 18,600 researchers work in pharmaceutical and biotechnology companies in Germany. Overall, investment in innovation in the German pharmaceutical industry amounts to one fifth of sales. A substantial share of pharma innovation in Germany is contributed by over 600 dedicated biotechnology companies that invested over EUR 1.1 billion in research and development in 2017. In the course of the global effort to develop vaccines and therapeutics to tackle the Covid-19 pandemic, German pharmaceutical and biotechnology companies have shown their strength: As of July 2020, there were over 40 products in development. Some of the research achievements made international headlines, such as CureVac's cooperation with Tesla for the production of an RNA vaccine and the fast-track designation for BioNTech's vaccine jointly developed with Pfizer.

Clinical Research

Thanks to its high population, Germany is an attractive study location - particularly for orphan diseases and other indications where participant recruitment is challenging. Main hotspots for clinical research are major cities like Berlin and metropolitan areas along the Rhine, Neckar, and Ruhr rivers. With 499 clinical studies initiated by the pharmaceutical industry in 2019, Germany ranks among the five leading locations worldwide - directly behind the USA, China, Spain and the UK. The most important indication areas, in terms of the number of clinical studies, are oncology and inflammatory diseases like asthma, Morbus Crohn and multiple sclerosis - followed by cardiovascular and infectious diseases as well as diabetes.

Business Location Germany

Europe's Economic Hub

Germany is the largest market in Europe. It is home to 16 percent of the EU's population and constitutes 21 percent of Europe's GDP (EU-28). After ten years of GDP growth and the recent economic slowdown caused by the Covid-19 pandemic, cur- rent forecasts expect a swift recovery of the German economy and positive GDP growth rates for 2021 and subsequent years. The country's economy is both highly industrialized and diversified - with equal focus placed on services and production.

Top Investment Location

Germany has a welcoming attitude towards foreign direct investment (FDI). Europe´s largest market creates a large and stable customer base for investors. Germany's integration into the world economy allows companies to gain and share knowledge, products and employees within a global network. With EUR 848 billion of FDI stocks in 2019, Germany is a major destination of FDI flows.

Sound and Secure Legal Framework

The legal framework for FDI in Germany favors the principle of freedom of foreign trade and payment. According to the World Economic Forum, Germany is one of the world's best locations in terms of planning and operating security. The country is also one of the world's leading nations in terms of intellectual property protection and protection from organized crime. The German legal system counts as one of the world's most efficient and independent.

Business-friendly Tax Conditions

Germany offers one of the most competitive tax systems of the big industrialized countries. The average overall tax burden for corporations is just below 30 percent. Significantly lower rates are available in certain German municipalities - up to seven percentage points less - with the overall corporate tax burden as low as 22.8 percent in some areas. Moreover, Germany provides an extensive network of double taxation agreements (DTAs) ensuring that double taxation is ruled out, for example, when dividends are transferred from a German subsidiary company to the foreign parent company.

World-class Infrastructure

With state-of-the-art transportation networks (road, rail, sea, and inland waterways) as well as a dense network of national and international airports, Germany provides easy access to domestic and international markets. Germany's infrastructure excellence is confirmed by a number of recent studies including the Swiss IMD's World Competitiveness Yearbook and various investor surveys conducted by organizations like the World Economic Forum (WEF) and Ernst & Young. The 2018 Logistics Performance Index of the World Bank ranked Germany first worldwide for its logistic proficiency, singling out Germany's quality of trade and transport infrastructure. Accumulated in this score for Germany are high marks for the quality of roads and air transport, excellent railroads and port infrastructure, as well as its outstanding electricity and water supply. As a truly global logistics hub, more goods pass through Germany than any other country in Europe.

Competitive Labor Costs

High productivity rates and steady wage levels make Germany an attractive investment location. Between 2009 and 2018 wages have risen in most European countries (EU-28), with the growth rate averaging 2.23 percent per year. While some countries - particularly those in Eastern Europe - experienced an annual increase of about 4 to 5 percent, Germany recorded one of the lowest labor cost growth rates (2.18 percent) in the manufacturing sector within the EU. Highly flexible working practices such as fixed-term contracts, shift systems, and 24/7 operating permits enhance Germany's global competitiveness as a suitable investment location for internationally active businesses.

Highly Skilled and Motivated Workforce

Germany's excellent workforce is decisive to the country's high productivity rates. It comprises over 44.6 million people - making it the largest European labor pool. More than 80 percent of the German workforce has received formal vocational training or is in possession of an academic degree. German labor flexibility is reflected in one of the highest employee motivation levels - exceeding those of most leading industrialized nations. Germans also lose significantly less days per annum to strike action than employees in other European nations.

Dual Education System

In order to secure the economy's demand for highly qualified personnel and to meet industry needs, Germany developed a dual system in vocational training - unique in combining the benefits of classroom-based and on-the-job training over a period of three years. In close cooperation with industry and the government, the German Chambers of Industry and Commerce (IHKs) and the German Confederation of Skilled Crafts (ZDH) ensure that exacting standards are adhered to, guaranteeing the quality of training provided across Germany.

Germany - A World-Class Pharmaceutical Location

Roche - Covering the Complete Value Chain Founded in 1896, the Swiss-based Roche Group is active in over 100 countries and employs about 98,000 people worldwide in 2019. With more than 30 research and development (R&D) locations worldwide, Roche continues to explore better and sustainable ways to prevent, diagnose and treat diseases. Roche has four strategically important sites in Germany - GrenzachWyhlen, Ludwigsburg, Mannheim, and Penzberg - which reflect the entire value chain of the Roche Group from R&D to production and patient care.

Between 2015 and 2017, Roche invested around EUR 600 million in its Penzberg biotechnology site to meet growing global demand for active pharmaceutical ingredients and diagnostic tests. With more than 5,000 employees the site is the company's largest biotech research, development and production center worldwide. In May 2020, Roche Chairman Christoph Franz announced additional investments of more than EUR 400 million in Penzberg to produce antibody tests for the new corona- virus and further R&D activities. The group is also investing in new business areas including digital health solutions. In 2020, Roche established its RoX Health offshoot in Berlin to provide financial and regulatory support to innovative healthcare start- ups. Germany plays an important strategic role for Roche in both innovation and market terms, with the country driving many of the group's innovations and playing a leading role in European market harmonization in a post-Brexit landscape.

Roche's strong presence in Germany provides the group with access to a strong healthcare market, an innovative R&D landscape as well as significant opportunities and benefits within the European single market. Germany also constitutes the Roche legal entity for all EU pharma licenses.

Takeda - Providing a Production Advantage

Takeda is a global biopharmaceutical company headquartered in Japan. Specializing in rare diseases, gastroenterology, oncology, neuroscience, plasma-derived therapies and vaccines, Takeda is the largest pharmaceutical company in Japan and one of the world's top 10 pharmaceutical companies by revenue. Established in Osaka in 1781, the company has been active in Germany since 1981. Takeda currently employs around 2,500 people at four locations in Germany, with half located in the Berlin-Brandenburg region and the other half in Baden-Württemberg. Germany's position as a world-leading pharmaceutical production site with a highly qualified workforce and synergies with other industries - including the mechanical engineering sector - provides a major location advantage to Takeda. The two production sites in Singen and Oranienburg play an important role in the company's global manufacturing and supply network. Almost 2,000 people are employed at the two production facilities producing high-quality pharmaceuticals for more than 100 countries worldwide.

"Germany is a world-class location for pharmaceutical production. Our products can only be made as part of a sophisticated production process that guarantees the highest level of quality. Germany provides us with this as well as a highly trained workforce and excellent infrastructure."

Heidrun Irschik-Hadjieff

General Manager Takeda Pharma Vertrieb GmbH & Co. KG, Spokesperson & Member of the Management Board Takeda GmbH

Takeda has invested more than EUR 200 million in its German production facilities in recent years, increasing output of its Oranienburg site by 50 percent in 2017. The state of Brandenburg provided funding of EUR 23 million on top of Takeda's own investment of EUR 100 million in Oranienburg. More than six billion tablets and capsules are produced at the facility annually - with 98 percent of production destined for export markets. In 2019, the company also opened its first worldwide dengue vaccine production in Singen. Takeda's commercial organization in Berlin employs around 500 people. The Berlin location allows Takeda to network with all important health economy stakeholders - from industry associations and patient organizations to health insurance companies and health policymakers. The German capital region counts as one of Europe's most important healthcare industry locations, boasting a unique concentration of university and non-university research institutions, clinics and life science companies.

Source: GTAI

https://www.gtai.de/gtai-en/invest/industries/life-sciences/pharmaceuticals

Leading Companies

Aenova Group

The parent company of the global Aenova Group is the German company, Aenova Holding Gmbh.

The Aenova Group is global leader in the pharmaceutical and healthcare industries. Competence and experience are the key factors for our success. With an emphasis on innovative technologies and high quality standards, we are a reliable partner for the pharmaceutical and healthcare industry.

Aenova is one of the leading contract manufacturers in Europe (CDMO). The range of services comprises the entire value chain for the development and manufacture of all main dosage forms (solid, semi-solid, and liquid) and product groups for medicines and dietary supplements.

Aenova provides a full service for customers from industry and commerce that covers everything from product development, raw material procurement, production, and analytics right up to packaging and logistics.

High standards of quality, innovative technologies, and a clear focus on the future ensure the continuing success and dynamic growth of the Group. We make long-term investments in the development of new products and the improvement of our production processes. At the same time, we are able to flexibly and rapidly react to changing requirements from customers and markets. Thanks to this strategy, Aenova ensures its long-term competitiveness and continuously increases its market share.

The Group operates 22 sites in eight European countries, Asia and the USA. 10 of our sites and our company headquarters are located in Germany. More than 4,300 employees contribute to our success.

https://www.aenova-group.com/en/competence-crucial

The Aenova Group publishes Annual Report 2022

Starnberg, 01/08/2023

The Aenova Group publishes its 2022 Annual Report today.

The key figures 2022 of Aenova at a glance:

€ 749 million Net Sales 2022

€ 107 million adjusted EBITDA

+ 22% Order book

"We continued to expand our capacities to allow for future growth and continue to grow our technology offering to increase our competitiveness in the market," said Jan Kengelbach, CEO of Aenova Group. "We inaugurated a full new aseptic manufacturing facility for high-speed PFS and vial filling including large molecule fill and finish. Our new high-speed, large volume solid plant expansion in Tittmoning went online, and we continued to build our expansions in Kirchberg for softgel capsule packaging. We made good progress in Carugate building a high-speed liquids and semi-solid manufacturing or in Regensburg establishing a future high-potent manufacturing to come online in 2024 and 2025 respectively. This strategy of capacity expansion and capability extension through the introduction of new technologies and superior development service offering continues to serve us very well", Jan Kengelbach added.

Despite an increased revenue by +7.5% from EUR 697 m to EUR 749 m, the EBITDA declined from EUR 107 m to EUR 97 m by 9%. Future perimeter adjusted for the closure of the site in Wolfratshausen, the business grew by 10%

from EUR 651 m to EUR 714 m, while EBITDA declined by 2% from EUR 104 m to EUR 102 m.

Learn more about Aenova's 2022 achievements and milestones, as well as key events in each business unit.

https://www.aenova-group.com/en/news-events/news/03-08-2023-the-aenova-group-publishes-annual-report-2022

Bayer Group (FRA: BAYN)

The parent company of the global Bayer Group is the German company, Bayer AG (FRA: BAYN).

Bayer is a Life Science company with a more than 150-year history and core competencies in the areas of health care and agriculture. With our innovative products, we are contributing to finding solutions to some of the major challenges of our time.

The Bayer Group is managed as a life science company with three divisions - Pharmaceuticals, Consumer Health and Crop Science - and the Animal Health business unit, which are also our reporting segments. The Enabling Functions support the operational business. In 2019, the Bayer Group comprised 392 consolidated companies in 87 countries.

The Pharmaceuticals division focuses on prescription products, especially for cardiology and women's healthcare, and on specialty therapeutics in the areas of oncology, hematology and ophthalmology. The division also comprises the radiology business, which markets diagnostic imaging equipment together with the necessary contrast agents.

The Consumer Health division markets mainly nonprescription (OTC = over-the-counter) products in the dermatology, nutritional supplement, analgesic, digestive health, cold, allergy, sinus and flu categories.

The Crop Science division is a world-leading agriculture enterprise with businesses in seeds, crop protection and nonagricultural pest control. The Crop Protection / Seeds operating unit markets a broad portfolio of high-value seeds and innovative pest management solutions, while at the same time providing extensive customer service for sustainable agriculture. The Environmental Science operating unit provides products and services for professional nonagricultural applications, such as vector and pest control and forestry.

The Animal Health business unit ranks among the leading international innovators in its field. It develops and markets products and solutions for the prevention and treatment of diseases in companion and farm animals.

https://www.bayer.com/en/profile-and-organization.aspx

https://www.bayer.com/

Second quarter impacted by declines in glyphosate business

Group sales fall by 8.2 percent (Fx & portfolio adj.) to 11.044 billion euros / EBITDA before special items: 2.527 billion euros (minus 24.5 percent) / Crop Science business down significantly, mainly due to sharp decline in glyphosate volumes and prices / Stable sales at Pharmaceuticals (Fx & portfolio adj.), earnings below prior year / Consumer Health records higher sales (Fx & portfolio adj.), earnings up slightly / Core earnings per share at 1.22 euros (minus 36.8 percent) / Net income at minus 1.887 billion euros, weighed down by impairment losses of 2.301 billion euros / Free cash flow at minus 473 million euros / Group outlook for 2023 lowered on July 24.

Leverkusen, August 8, 2023 - Bayer published detailed results for the second quarter of 2023 on Tuesday, after having already communicated key figures for the three-month period and lowering its outlook for full-year 2023 in a July 24 news release. The revised guidance was mainly due to a significant further decline in sales of glyphosate-based products at the Crop Science Division. Sales at Pharmaceuticals were stable on a currency- and portfolio-adjusted basis (Fx & portfolio adj.), while earnings were down year on year. Consumer Health registered higher sales (Fx & portfolio adj.) and also increased earnings.

Group sales declined by 8.2 percent (Fx & portfolio adj.) to 11.044 billion euros in the second quarter. There was a negative currency effect of 553 million euros (Q2 2022: positive currency effect of 915 million euros). EBITDA before special items declined by 24.5 percent to 2.527 billion euros. This figure included a negative currency effect of 120 million euros (Q2 2022: positive currency effect of 300 million euros). By contrast, the company registered income across all divisions totaling around 481 million euros due to a decrease in provisions for the Group-wide Short-Term Incentive program. EBIT came in at minus 956 million euros (Q2 2022: plus 169 million euros) after net special charges of 2.490 billion euros (Q2 2022: 2.111 billion euros) that primarily related to unscheduled impairment testing in the Crop Science Division. As a result, net income came in at minus 1.887 billion euros (Q2 2022: minus 298 million euros). Core earnings per share decreased by 36.8 percent to 1.22 euros.

Free cash flow amounted to minus 473 million euros (Q2 2022: plus 1.140 billion euros), primarily due to the decline in business at the Crop Science Division. At 39.620 billion euros, net financial debt as of June 30, 2023, was 9.8 percent higher than at the end of March 2023.

Crop Science sales without glyphosate at prior-year level (Fx & portfolio adj.)

Sales in the agricultural business (Crop Science) fell by 18.5 percent (Fx & portfolio adj.) to 4.924 billion euros, mainly driven by lower volumes and prices for glyphosate-based products. This effect particularly impacted business in North and Latin America as well as in Europe/Middle East/Africa, and resulted in a 45.6 percent decrease in sales (Fx & portfolio adj.) at Herbicides. Excluding the glyphosate business, Crop Science sales were level with the previous year (Fx & portfolio adj.), as higher prices were offset by lower volumes. Sales at Corn Seed & Traits rose by 10.6 percent (Fx & portfolio adj.), largely thanks to higher prices in all regions as well as increased acreages in North America. Business at Fungicides was level with the prior-year quarter (Fx & portfolio adj.). Sales at Soybean Seed & Traits were down 9.3 percent (Fx & portfolio adj.), mainly due to decreased acreages and a decline in license revenues in North America.

EBITDA before special items at Crop Science fell by 58.5 percent to 725 million euros, primarily due to the decline in sales of glyphosate-based products. Higher prices in the rest of the business and cost savings only partially compensated for this effect. Earnings were also diminished by a mainly inflation-related increase in the cost of goods sold and a negative currency effect of 96 million euros (Q2 2022: positive currency effect of 215 million euros).

Pharmaceuticals: new products deliver substantial growth

Sales of prescription medicines (Pharmaceuticals) came in at 4.557 billion euros, matching the prior-year level on a currency- and portfolio-adjusted basis. The division's new products achieved significant gains: Sales of the cancer drug Nubeqa™ nearly doubled, while Kerendia™ for the treatment of chronic kidney disease associated with type 2 diabetes saw business expand more than threefold. In addition, the Radiology business continued to grow, mainly driven by gains for the CT Fluid Delivery and Ultravist™ product families. Sales of the ophthalmology drug Eylea™ also increased, with growth of 5.6 percent (Fx & portfolio adj.) driven by higher volumes in all regions and particularly in North America and Asia/Pacific. By contrast, the division recorded a decline in sales in China, partly due to tender procedures for Adalat™. On a global level, sales of the cardiovascular drug decreased by 26.1 percent (Fx & portfolio adj.). Business in China was also impacted by a decrease in demand for Aspirin™ Cardio, with global sales falling 29.3 percent (Fx & portfolio adj.). As expected, global sales of the oral anticoagulant Xarelto™ were down, with competitive pressure from generic products as well as lower prices, particularly in Asia/Pacific and Latin America, resulting in a decrease of 3.3 percent (Fx & portfolio adj.).

EBITDA before special items at Pharmaceuticals declined by 6.7 percent to 1.379 billion euros, largely due to higher R&D investments in cell and gene therapy and chemoproteomics technologies, as well as in projects in advanced clinical development. In addition, the prior-year quarter had received a significant boost from the sale of non-core businesses. There was a negative currency effect of 40 million euros (Q2 2022: positive currency effect of 41 million euros).

Consumer Health continues to grow

Sales of self-care products (Consumer Health) increased by 5.4 percent (Fx & portfolio adj.) to 1.466 billion euros compared to a strong prior-year quarter, with contributions from all regions. The division posted significant gains in the Dermatology business, with growth of 10.9 percent (Fx & portfolio adj.) driven partly by continued high demand for Bepanthen™, as well as in the Pain & Cardio category, where sales rose by 10.0 percent (Fx & portfolio adj.). In addition, sales of cough and cold products increased significantly amid a persistently strong cold season, while the allergy business expanded slightly despite a weaker allergy season due to weather-related factors. Overall, the Allergy & Cold category registered growth of 5.7 percent (Fx & portfolio adj.). The division continued to face some supply constraints in the second quarter, particularly in the Digestive Health category, where sales were level with the prior-year period (Fx & portfolio adj.). The supply situation is expected to improve in the second half of the year.

EBITDA before special items at Consumer Health increased by 1.5 percent to 335 million euros following a very strong prior-year quarter, driven by continuous operational productivity and price management measures. These efforts compensated for ongoing inflation-driven cost increases and investment in marketing innovative products. The division also recorded higher proceeds from the sale of minor, non-strategic brands. There was a negative currency effect of 31 million euros (Q2 2022: positive currency effect of 49 million euros).

Group outlook lowered on July 24

The Bayer Group lowered its outlook for full-year 2023 on July 24, mainly due to a significant further decline in sales of glyphosate-based products. When communicating its first quarter results, Bayer had already guided towards the lower end of the forecast it had previously issued. On a currency-adjusted basis (i.e. based on the average monthly exchange rates from 2022), Bayer now expects to generate sales of between 48.5 and 49.5 billion euros (initial forecast: 51 to 52 billion euros). This now corresponds to a decline of 2 to 3 percent on a currency- and portfolio-adjusted basis (initial forecast: increase of 2 to 3 percent). EBITDA before special items is now expected to come in at 11.3 billion to 11.8 billion euros on a currency-adjusted basis (initial forecast: 12.5 to 13.0 billion euros). The company now anticipates core earnings per share of 6.20 to 6.40 euros on a currency-adjusted basis (initial forecast: 7.20 to 7.40 euros). In addition, it now projects free cash flow of approximately zero euros (initial forecast: approximately 3.0 billion euros) and net financial debt of approximately 36 billion euros (initial forecast: 32 to 33 billion euros) on a currency-adjusted basis. Bayer now expects to take special items of around minus 3.5 billion euros (initial forecast: around minus 1.0 billion euros) in EBIT after adjusting for currency effects.

With respect to the divisions, the company now expects Crop Science sales to fall by around 5 percent year on year (initial forecast: increase by around 3 percent) and Pharmaceuticals sales to show a roughly 0 percent change against the prior-year level (initial forecast: increase by approximately 1 percent) after adjusting for currency and portfolio effects. The currency-adjusted EBITDA margin before special items is now projected to come in at around 21 percent at Crop Science (initial forecast: 25 to 26 percent) and approximately 28 percent at Pharmaceuticals (initial forecast: slightly above 29 percent). The forecast for Consumer Health remains unchanged, with sales growth of roughly 5 percent on a currency- and portfolio-adjusted basis, and a currency-adjusted EBITDA margin before special items of around 23 percent.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. 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. These factors include those discussed in Bayer's public reports which are available on the Bayer website at
www.bayer.com
. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

https://www.bayer.com/media/en-us/second-quarter-impacted-by-declines-in-glyphosate-business/

B. Braun Group

The parent company of the global B. Braun Group is the German company, B. Braun Melsungen AG.

True partner. Smart solutions. Set standards.

As one of the world's leading medical technology companies, B. Braun aims to protect and improve the health of people around the world. For more than 180 years, we have shaped health care with our pioneering spirit and groundbreaking contributions.

https://www.bbraun.com/en/about-us/company.html

B. Braun closes 2022 fiscal year with sales growth - result burdened

The B. Braun Group recorded 8.5 billion euros in sales in FY 2022 (previous year: 7.9 billion euros). Adjusted for currency effects, this is an increase of 3.6 percent. The result was burdened by high expenses to maintain supply availability as well as one-off effects.

"2022 was a difficult year in which B. Braun was strongly challenged," said B. Braun CEO Anna Maria Braun today at a virtual press conference.

"But we were able to continue our growth in a persistently volatile market through special dedication and reliably supplied products and services to our customers. Particularly now, when pressure on health care systems continues to increase, at B. Braun we are aware of our special responsibility and are working hard to provide quality health care to more people around the world together with our customers."

B. Braun's sales were positive in nearly every region and across broad segments of its portfolio. Sales fell for some products that were in very high demand during the coronavirus pandemic but saw less demand in FY 2022. Hospital Care benefited overall from stable volumes and price adjustments caused by inflation. The surgical division Aesculap recovered from the significant burdens caused by the pandemic in 2020 and 2021, as more elective surgeries were performed worldwide. Demand steadily increased, especially for knee and hip implants as well as surgical instruments and suture materials. Avitum could not recapture the increased sales in the infection prevention business seen during the pandemic, but sales improved in the therapeutic areas of extracorporeal blood treatment as well as wound management, ostomy care and continence care.

The B. Braun Group's result in 2022 was burdened by external and internal effects, especially significantly higher costs for raw materials, energy and logistics, which contributed to less profit compared to the previous year. There were also unscheduled amortizations of discontinued production and development projects totaling 96.3 million euros. EBITDA was 9.5 percent below the previous year, totaling 997.2 million euros (previous year: 1,101.9 million euros). The EBITDA margin fell to 11.7 percent (previous year: 14.0 percent). Profit before taxes reached 178.7 million euros (previous year: 408.6 million euros). Adjusting for unscheduled amortization, profit before taxes was 275.0 million euros (previous year: 408.6 million euros).

"We're not satisfied with the earnings situation," said Braun. "It's even more important that we took prompt corrective action, early in the reporting year to improve our profitability. This allowed us to stabilize our result, even if price increases and cost reductions couldn't completely compensate for the negative effects. At B. Braun we will continue to consistently adjust our collaborations, our structures and business models to the changing world this fiscal year—our goal remains meeting customer needs even more quickly and with greater flexibility, and to drive advancements in health care."

B. Braun continues to invest in the future

Global measures to stabilize the result allowed B. Braun to continue to invest during FY 2022. A total of over one billion euros was invested in financial instruments and property, plants and equipment as well as in research and development. Investment projects included the continued construction of a new production plant for single-use infusion therapy products in Melsungen, Germany, new manufacturing facilities for infusion therapy products in Daytona Beach, FL, and Allentown, PA, in the USA, as well as construction of a modern dialysis concentrate production plant in Hanoi, Vietnam. Through its Aesculap division, B. Braun also expanded access to endoscopic visualization technology by acquiring the remaining shares in Schölly Fiberoptic GmbH Denzlingen, Germany.

Consistently pursuing strategy in a difficult market environment

In order to continue to operate successfully as a private, family-owned company, B. Braun took a critical look at its productivity, structures and processes in the reporting year. The company's goal is to continue to standardize, digitalize and simplify processes under its B. Braun—the next decade strategy. Appropriate changes and more efficient collaboration resulted in the number of B. Braun employees decreasing to 65,055 (previous year: 66,778) as of December 31, 2022.

New possibilities through technology and sustainability

In health care, new technologies offer possibilities for treating people around the world using the highest medical standards, while also ensuring the affordability of care through better efficiency. This also motivated B. Braun in FY 2022 to make innovative solutions accessible to customers, patients, and a wider health care industry. The company offers high-quality product systems enabled by technologies it continues to refine. One example is B. Braun's Spaceplus infusion pump system, which can be connected to hospital data management systems. Infusion data is automatically transmitted and made accessible to medical staff for patient treatment. In the operating room, our Aesculap Aeos® robot-assisted surgical microscope deploys the latest imaging techniques, setting new benchmarks for depth of field, field of view and lighting. (www.bbraun.com/view-of-the-future)

B. Braun also employs technological developments to weave sustainability through its supply chains, production and logistics processes, and resource management. The company continued to improve its sustainability structures to attain a competitive edge through professional sustainability management for the future. One example is B. Braun's dialysis equipment, which conserves resources and improves processes by using less water, energy, and materials. (www.bbraun.com/dialysis-is becoming-green)

Outlook

B. Braun expects positive sales and results in FY 2023. The company also expects the current high prices for raw materials, energy, and logistics services to continue over the short and medium term. In response, in 2023 B. Braun will continue to reinforce the structural changes started in 2022. The contribution to profit expected from these changes should offset cost increases and continue to improve profitability.

https://www.bbraun.com/en/about-us/media/press-releases/b--braun-closes-2022-fiscal-year-with-sales-growth---result-burd.html

Boehringer Ingelheim Group

The parent company of the global Boehringer Ingelheim Group is the German company, C.H. Boehringer Sohn AG & Co . KG.

Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

https://www.boehringer-ingelheim.com/

https://www.boehringer-ingelheim.com/corporate-profile/our-company

First half of 2023: Boehringer Ingelheim sees strong growth and expansion in key therapy areas

Ingelheim, Germany, Tuesday, 01/08/2023 - 09:00

Areas of progress include rare skin diseases, cardio-renal-metabolic diseases, and immuno-oncology

Jardiance® and NexGard® portfolios drive strong growth

First half 2023 net sales up 9.7 percent at 12.2 billion EUR year on year and currency-adjusted

Boehringer Ingelheim, a leading research-driven biopharmaceutical company, continues to advance its pipeline in both Human Pharma and Animal Health expanding across its key therapy areas.

Currency-adjusted net sales rose by 9.7 percent to 12.2 billion EUR driven by high demand for medications during the first six months of 2023, driven by strong momentum in Jardiance® for Human Pharma and NexGard® for Animal Health.

"True innovation addressing high unmet patients' needs has enabled us to reach ever more patients in the first half of this year," said Hubertus von Baumbach, Chairman of the Board of Managing Directors. "Persistent and above-average investments in our pipeline during the last years have resulted in many new treatment options for patients in the years to come, thus transforming lives for generations."

Boehringer Ingelheim continued expanding its pipeline portfolio through in-house as well as external innovation - 15 new innovation partnerships were formed in areas such as cancer immunology, fibrotic lung diseases and retinal diseases. Overall, the company has committed to invest 25 billion EUR in Research & Development and an additional 7 billion EUR for new production technologies over the next five years.

Net sales in Human Pharma were up 11.3 percent (currency-adjusted) at 9.6 billion EUR in the first half of the year, mainly driven by the Jardiance® family at 3.5 billion EUR and the respiratory medicine OFEV® at 1.7 billion EUR.

Jardiance® experienced strong momentum in the first six months of 2023. It is expected to grow following additional regulatory action for treatment of chronic kidney disease. Worldwide 850 million people1 live with this disease. With the addition to existing indications in type 2 diabetes and heart failure, Jardiance® will potentially be able to help manage cardio-renal-metabolic conditions. Over 1 billion people live with cardio-renal-metabolic conditions globally1.

In oncology, the company's MDM2-p53 agonist brigimadlin has advanced into the pivotal trial for the treatment of dedifferentiated liposarcoma, a rare cancer with limited treatment options so far. The clinical development of two additional investigational therapies (zongertinib, also known as BI 1810631, and BI 764532) from the oncology pipeline has been accelerated based upon positive early clinical data.

The PDE4B inhibitor BI 1015550 is now in two clinical Phase III trials for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis. Patient recruitment for trial investigating BI 1015550 in IPF is well ahead of plan.

"We have become very successful in bringing new products through our pipeline addressing patients' needs faster," said Michael Schmelmer, Member of the Board of Managing Directors, responsible for Finance & Group Functions. "We expect to further increase our R&D spending as clinical trials progress into late-stage phases."

Animal Health recorded growth in Pets and Livestock, with sales increasing by 3.8 percent (currency-adjusted) to 2.5 billion EUR in the first six months of the year. Net sales of NexGard®, a flea and tick prevention for dogs and cats, increased 9.2 percent (currency-adjusted) to 644 million EUR, while Ingelvac Circoflex®, a vaccine used to protect pigs against porcine circovirus type 2, rose 8.7 percent to 127 million EUR.

In addition, the company complemented its market-leading NexGard® portfolio through FDA approvals for NexGard® PLUS, a new monthly combination product for dogs that protects against fleas, ticks, heartworm disease, roundworms and hookworms, and NexGard® COMBO, the first-and-only feline broad-spectrum parasite protection that treats tapeworms.

The Animal Health business has made further progress in the pipeline development in infectious and non-infectious diseases for Pets and Livestock and is preparing for the launch of a highly innovative oral product for diabetes in cats.

For the remainder of the year Boehringer Ingelheim expects more progress in its innovation efforts, such as data readout for a Phase III trial with empagliflozin in patients after myocardial infarction and upcoming regulatory action for OFEV® in children and adolescents between 6-17 years with interstitial lung disease.

Looking forward, the company aims to achieve more than 30 new medical approvals in Human Pharma by 2029 and expects around 20 product launches in Animal Health through 2025.

Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com

https://www.boehringer-ingelheim.com/about-us/corporate-profile/boehringer-ingelheim-half-year-results-2023

Carl Zeiss Meditec Group (FRA: AFX)

The parent of the global Carl Zeiss Meditec Group is the German company, Carl Zeiss Meditec AG (FRA: AFX).

Under the umbrella of the TecDAX-listed company Carl Zeiss Meditec AG, which is one of the world's leading medical technology companies, the Medical Technology activities of ZEISS are bundled. Carl Zeiss AG holds ca. 65 percent interest.

Carl Zeiss Meditec AG, Jena, Germany, is the parent company of the Carl Zeiss Meditec group, which comprises additional subsidairies such as Carl Zeiss Meditec Inc. and Carl Zeiss Meditec Iberia S.A.

The Carl Zeiss Meditec AG has set itself the task to develop innovative products to improve the diagnosis and treatment of diseases. The solutions the Company develops aim to simplify clinical workflows and allow physicians to focus all their attention on their work and their patients. After all, at the end we want the patient to leave the clinic with the best possible outcome and a high level of satisfaction.

We supply and provide

innovative technologies and application-oriented solutions designed to help doctors improve their patients' quality of life

complete packages of solutions for the diagnosis and treatment of ophthalmic diseases, including implants and consumables

innovative visualization solutions in the field of microsurgery

promising, future-oriented technologies such as intraoperative radiotherapy.

Therefor we are guided by our Mission to uniquely enable healthcare professionals worldwide to improve the lives of their patients in ophthalmology, microsurgery and other medical growth sectors and advance the standards of care with our proven medical technology and application competence. Together with our colleagues at sites all over the world, we work to achieve this goal on a daily basis.

https://www.zeiss.com/meditec-ag/about-us.html

Carl Zeiss Meditec AG (ISIN: DE 0005313704), which is listed on TecDAX and SDax of the German stock exchange, is one of the world's leading medical technology companies. The Company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat eye diseases. The Company creates innovative visualization solutions in the field of microsurgery. With 3,232 employees (as of 30 September 2019) worldwide, the Group generated revenue of €1,459.3m in fiscal year 2018/19 (as of 30 September).

The Group's head office is located in Jena, Germany, and it has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research (CARIn) in Bangalore, India and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the Company's presence in these rapidly developing economies. Around 41 percent of Carl Zeiss Meditec AG's shares are in free float. The remaining approx. 59 percent are held by Carl Zeiss AG, one of the world's leading groups in the optical and optoelectronic industries.

https://www.zeiss.com/meditec/int/news.html

Carl Zeiss Meditec achieves slight revenue growth in first quarter of 2023/24

Decline in profit due to expected weaker product mix

Jena, Germany | February 9, 2024 | Carl Zeiss Meditec AG

Carl Zeiss Meditec generated revenue of €475.0m in the first quarter of fiscal year 2023/24 (prior year: €470.3m), corresponding to a growth of +1.0% (adjusted for currency effects: +3.3%). Order backlog normalized to around €315m. Earnings before interest and taxes (EBIT) declined to around €43.5m (prior year: €60.3m). The EBIT margin was 9.2% (prior year: 12.8%).

Dr. Markus Weber, President and CEO of Carl Zeiss Meditec AG commented on the Q1 results: "We have made a solid start to the new fiscal year. The planned measures to clear the Chinese distribution channel as well as currency developments have impacted revenue and earnings as anticipated. However, a positive effect resulted from the equipment business, which achieved good deliveries and significantly improved production times."

Revenue growth primarily boosted by equipment business and SBU Microsurgery

Revenue in the Ophthalmic Devices strategic business unit (SBU) decreased by -2.0% in the first three months of fiscal year 2023/24 (adjusted for currency effects: 0.0%), to €351.1m (prior year: €358.2m). In particular the planned reduction of stocks of consumables for refractive surgery in the Chinese distribution channel had an adverse effect. Currency effects also had a negative impact.

The strategic business unit Microsurgery achieved revenue growth of +10.6% (adjusted for currency effects: +13.7%) to €123.9m (prior year: €112.0m). The SBU continued to benefit from the reduction of the high order backlog.

Heterogeneous sales development in the reporting regions

Revenue in the EMEA 1 region increased by +28.2% (adjusted for currency effects: +30.9%) to €156.5m (prior year: €122.1m). The core markets France, Italy and Spain are making positive contributions to growth.

Revenue in the Americas region decreased by -19.9% (adjusted for currency effects: -16.6%) from €139.9m to €112.1m. The positive trend in Latin America continued, while the U.S. experienced a decline at the start of the fiscal year.

The APAC 2 region recorded a slight decline in revenue of -0.9% (adjusted for currency effects: +0.4%), to €206.4m (prior fiscal year: €208.2m). India and Southeast Asia are making positive contributions. The Chinese market, meanwhile, showed a decline in revenue due to the planned reduction of stocks of surgical consumables.

Operating result down compared with prior year, as expected

The operating result (earnings before interest and taxes, EBIT) declined in the first quarter of fiscal year 2023/24, to €43.5m (prior year: €60.3m). As expected, gross profit came under considerable pressure due to a less favorable product mix - resulting from a higher proportion of devices and a lower proportion of consumables due to the reduction of stocks in the Chinese distribution channel.

The EBIT margin in the first three months of fiscal year 2023/24 was 9.2% (prior year: 12.8%). Adjusted for special effects, this figure was 9.7% (prior year: 13.4%). Earnings per share benefited from gains on currency hedges and amounted to €0.42 in the first quarter (prior year: €0.57).

Outlook for the further course of business in 2023/24

In spite of geopolitical risks and an increasingly difficult macroeconomic environment, the Company generally expects to see further market growth. Revenue is expected to grow at least in line with the market growth. A gradual recovery of the EBIT margin is expected in the further course of the year. EBIT for fiscal year 2023/24 as a whole is expected to be around the prior year's level.

All figures in €m
3 months 2023/24
3 months 2022/23
Change from prior year
Change from prior year (currency-adjusted)
Ophthalmology
351.1
358.2
-2.0%
0,0%
Microsurgery
123.9
112.0
+10.6%
+13.7%
Consolidated
475.0
470.3
+1.0%
+3.3%

https://www.zeiss.com/meditec-ag/en/media-news/press-releases/2024/interim-report-q1-fy-2023-24.html

Desitin Arzneimittel GmbH

The company
Desitin Arzneimittel GmbH
is active on international (Germany, Switzerland, Scandinavia, Eastern Europe) level. At our Hamburg plant we produce sophisticated products for the treatment of neurological and psychiatric illnesses and offer a large number of established and innovative products, especially for our core indications epilepsy and Parkinson syndrome.

The optimisation of pharmacotherapy through continuous development and in cooperation with other future-oriented companies, e.g. diseases of the central nervous system, is one of Desitin's main areas of activity and investment.

Ongoing training and scientific information as well as cooperation with the treating physicians and centres are our company's further contribution to long-term treatment success for neurological-psychiatric illnesses.

We regard ourselves as a partner for physicians, pharmacists and patients as well as their families and provide extensive service as product support. Our highly specialised field staff as well as our medical employees provides the physicians with expert and competent assistance.

We also regard ourselves as advocates to patients suffering from epilepsy and Morbus Parkinson in order to protect them from negative effects on their diagnosis and treatment during changes in public health care. In this regard we seek and find dialogue with cost carriers and health ministers in order to increase their understanding of the special requirements of these CNS illnesses.

https://www.desitinpharma.com/about-desitin/the-company/

https://www.desitinpharma.com/portal/

Desitin is focused on pharmaceuticals for the treatment of epilepsy. It is the only manufacturer that offers the entire spectrum of products recommended by the WHO for the treatment of epilepsy.

Desitin not only offers a wide range of different therapeutics, but also a broad spectrum of presentations and dosage strengths.

Whereas most of these preparations have been developed inhouse by Desitin and successfully sold within various countries of Europe, co-operations with licensors and the successful marketing of products licenced represent a corner stone of Desitin's latest developments.

https://www.desitinpharma.com/about-desitin/the-company/company-profile/

Fresenius Group (FRA: FRE)

The German company, Fresenius SE & Co. KGaA (FRA: FRE), is the parent of the global Fresenius Group which includes the German companies Fresenius Medical Care AG & Co. KGaA, Fresenius Kabi AG, Helios Kliniken GmbH and VAMED AG.

https://www.fresenius.com/worldwide

Fresenius is a global healthcare group offering high-quality products and services for dialysis, hospitals, and outpatient treatment. With over 290,000 employees in more than 100 countries around the globe, and annual sales exceeding €35 billion, Fresenius is one of the world's leading healthcare companies.

The Fresenius Group includes four independently operated business segments, each one active in a major growth area of healthcare.
Fresenius Medical Care
is the world leader in treating people with chronic kidney failure.
Fresenius Helios
is Europe's largest private hospital operator.
Fresenius Kabi
supplies essential drugs, clinical nutrition products, medical devices and services to help critically and chronically ill patients, while
Fresenius Vamed
plans, develops and manages healthcare facilities.

At Fresenius, the patient always comes first. For more than 100 years now we have been working to save lives and improve the quality of life of our patients. A clear focus on innovation and efficiency has helped us to make high-quality healthcare accessible to a steadily increasing number of people. Yet we never get complacent about our successes, and never stop looking for better solutions. This is how Fresenius is contributing to medical progress and better patient care.

Success in our business is the key for investing in high-quality yet affordable healthcare. In this way we are meeting our social responsibility to help patients, while ensuring that Fresenius remains successful over the long term.

Fresenius leads by recognizing important trends and developments early, then working with our partners to help shape healthcare systems. Aging populations and the expansion of healthcare provision in countries worldwide are driving demand for medical products and services, and Fresenius is excellently positioned to continue our strong growth into the future.

At Fresenius, "Forward Thinking Healthcare" captures our commitment to the future: better medicine for more people.

https://www.fresenius.com/Group-Overview

Fresenius Medical Care delivers on commitments in a year of fundamental transformation

02/20/2024 | Press release

Revenue growth of 5% in 2023 driven by favorable business development

Operating income 1 growth of 15% exceeding top end of outlook range, due to business growth, FME25 savings ahead of plan and contributions from the Tricare settlement

Successful execution on turnaround plan resulting in significant labor productivity improvements in Care Delivery and positive pricing in Care Enablement

Several key divestments announced as part of the ongoing Portfolio Optimization Program

Strong cash flow performance and net financial leverage ratio reduced

Dividend of €1.19 per share proposed

For 2024 continued revenue growth and accelerated operating income growth projected

Helen Giza, Chief Executive Officer of Fresenius Medical Care, said: "In 2023, we delivered on our commitments while we fundamentally transformed Fresenius Medical Care. Exceeding our upgraded financial outlook for the full year was the very successful finish to an extraordinary year. We implemented the new global operating model, progressed on our operational turnaround ambitions, changed our legal form and advanced on the Portfolio Optimization Program through key divestments. Thanks to the commitment of our 120,000 employees, the high quality of care for our patients remains front and center in everything we do. Based on the turnaround progress achieved last year, we have a strong foundation to build on to make 2024 a year of accelerated profitable growth while progressing towards our ambitious mid-term margin target."

Key figures (IFRS)

Q4 2023 EUR m
Q4 2022 EUR m
Growth yoy
Growth yoy, cc
FY 2023 EUR m
FY 2022 EUR m
Growth yoy
Growth yoy, cc
Revenue
4,988
4,997
0%
+7%
19,454
19,398
0%
+5%
Operating income excl. special items and PRF 1
428 555
352 489
+22% +14%
+27% +18%
1,369 1,741
1,512 1,540
-9% +13%
-7% +15%
Net income 2 excl. special items and PRF 1
188 259
139 248
+35% +4%
+41% +8%
499 756
673 729
-26% +4%
-24% +6%
Basic EPS (EUR) excl. special items, and PRF 1
0.64 0.88
0.47 0.85
+35% +4%
+41% +8%
1.70 2.58
2.30 2.49
-26% +4%
-24% +6%

yoy = year-on-year, cc = at constant currency, EPS = earnings per share

Successful execution against the strategic plan

Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, successfully finished a year of significant transformation.

Structure: During fiscal year 2023, Fresenius Medical Care continuously advanced its structural change. After implementing the new operating model along with the corresponding new financial reporting at the start of the year, it ended with the successful completion of its change of legal form into a German stock corporation. Through this change, a simplified corporate governance structure gives the Company more flexibility and autonomy and strengthens the role of the free float shareholders.

Operational efficiency: In 2023, the company successfully executed on its operational efficiency improvement and turnaround plans. The FME25 transformation program reached annual sustainable savings of EUR 346 million, ahead of our initial plan for the year (EUR 250 to 300 million). Related one-time costs were EUR 153 million in 2023, adding up to EUR 420 million since the start of the program in 2021. The program continues well on track to achieving the targeted EUR 650 million of sustainable annual savings by year end 2025. The significant improvement in labor productivity in Care Delivery a year earlier than targeted, as well as the successful pricing initiatives in Care Enablement additionally supported the underlying positive earnings development.

Portfolio Optimization: Fresenius Medical Care announced several key divestments as part of the strategy to execute on its portfolio optimization program to exit non-core and dilutive assets. The divestments of National Cardiovascular Partners in the U.S. (closed), our operations in Argentina (closed) and Cura Day Hospitals Group in Australia (signed) generate EUR 0.5 billion in total proceeds, of which EUR 135 million were received in 2023. The three assets include 127 facilities, more than 4,500 employees, more than 10,000 dialysis patients. Divestments closed in 2023 accounted for EUR 214 million of revenue and EUR 20 million of operating income.

Capital Allocation: During 2023, Fresenius Medical Care strictly followed its disciplined financial policy. A significant increase of +32% in Free Cash Flow, mainly due to favorable contributions from working capital and the Tricare settlement was used to reduce its net financial debt by 11% to EUR 10.8 billion. The corresponding net leverage ratio (net debt/EBITDA) decreased to 3.2x at the end of 2023, compared to 3.4x at the end of 2022. The Company adheres to its dividend policy of developing dividends in line with the development of net income excluding special items. Consequently, the dividend proposal for fiscal year 2023 of EUR 1.19 per share corresponds to an increase by 6% compared to prior year's dividend.

Sustainability: Fresenius Medical Care continued to make progress towards its Sustainability goals. Underscoring the Company's focus on high quality care, the patients' overall satisfaction with our services measured by the Net Promoter Score of 72 was at an even higher level than in previous years. With its recent submission of the commitment letter to the Science Based Targets Initiative (SBTi), the Company underlines its goal to achieve climate neutrality in its operations by 2040 in line with the Paris Agreement.

Revenue development driven by solid organic growth

In the fourth quarter 2023, revenue remained flat with EUR 4,988 million (+7% at constant currency, +3% organic).

Care Delivery revenue remained flat with EUR 3,976 million in the fourth quarter 2023 (+8% at constant currency, +2% organic).

In Care Delivery U.S., revenue increased by 2% (+7% at constant currency, +1% organic). The increase was mainly driven by value-based care business growth, reimbursement rate increases, a favorable payor mix, an increase in dialysis days as well as the impact from the Tricare settlement in the amount of €191 million, partially offset by negative exchange rate effects. The annualization effect of COVID-19-related excess mortality in the late-stage CKD (Chronic Kidney Disease) and ESRD (End-Stage Renal Disease) population continues to weigh on same market treatment growth (-0.6%). Adjusted for the exit from less profitable acute care contracts same market treatment growth was flat.

In Care Delivery International, revenue declined by 11% (+10% at constant currency, +7% organic) as a negative exchange rate effect could only be partially offset by organic growth. Despite the annualization effect of COVID-19-related excess mortality, same market treatment growth was positive at 1.9%.

Care Enablement revenue declined slightly by 1% to EUR 1,380 million in the fourth quarter 2023 (+5% at constant currency, +6% organic). The negative exchange rate effects were partly offset by higher product sales as well as higher average sales prices.

Within Inter-segment eliminations 3 , revenue for products transferred between the operating segments at fair market value declined by 5% to EUR -368 million in the fourth quarter 2023 (+2% at constant currency).

In full year 2023 , revenue was stable at EUR 19,454 million (+5% at constant currency, +4% organic). Care Delivery revenue was stable at EUR 15,578 million (+5% at constant currency, +3% organic). In Care Delivery U.S., revenue increased by 1% (+3% at constant currency, +3% organic). Adjusted for the exit from less profitable acute care contracts, U.S. same market treatment growth was at +0.2%. Revenue in Care Delivery International declined by 4% (+12% at constant currency, +7% organic). Care Enablement revenue was stable at EUR 5,345 million (+5% at constant currency, +4% organic). Inter-segment eliminations 3 declined by 5% and amounted to EUR -1,469 million (stable at constant currency).

Earnings development driven by labor productivity improvements and FME25 savings

In the fourth quarter 2023, operating income increased by 22% to EUR 428 million (+27% at constant currency), resulting in a margin of 8.6% (Q4 2022: 7.0%). Operating income excluding special items and U.S. Provider Relief Funding (PRF) 1 increased by 14% to EUR 555 million (+18% at constant currency), resulting in a margin of 11.1% (Q4 2022: 9.8%).

Operating income in Care Delivery rose by 13% to EUR 515 million in the fourth quarter 2023 (+17% at constant currency), resulting in a margin of 13.0% (Q4 2022: 11.4%). Operating income excluding special items and PRF 1 increased by 12% to EUR 572 million (+16% at constant currency), resulting in a margin of 14.4% (Q4 2022: 12.8%). This was mainly driven by savings from the FME25 program and the impact of the Tricare settlement in the net amount of EUR 181 million. The operating income development was negatively impacted by our value-based care business, inflationary cost increases as well as higher expense related to performance-based compensation plans.

Operating income in Care Enablement amounted to EUR -42 million in the fourth quarter 2023 (Q4 2022: EUR -62 million), resulting in a margin of -3.1% (Q4 2022: -4.5%). Operating income excluding special items 1 improved from EUR -3 million in Q4 2022 to EUR 10 million, resulting in a margin of 0.7% (Q4 2022: -0.2%). The improvement compared to the previous year's quarter was primarily driven by savings from the FME25 program and positive pricing, partially offset by inflationary cost increases and unfavorable foreign currency transaction effects.

Operating income for Corporate amounted to EUR -44 million in the fourth quarter 2023 (Q4 2022: EUR -44 million). Excluding special items 1 , operating income amounted to EUR -26 million (Q4 2022: EUR -20 million).

In the full year 2023 , operating income decreased by 9% to EUR 1,369 million (-7% at constant currency), resulting in a margin of 7.0% (FY 2022: 7.8%). Excluding special items and PRF 1 , operating income increased by 13% to EUR 1,741 million (+15% at constant currency), resulting in a margin of 8.9% (FY 2022: 7.9%). In Care Delivery, operating income declined by 10% to EUR 1,516 million (-8% at constant currency), resulting in a margin of 9.7% (FY 2022: 10.8%). Operating income excluding special items and PRF 1 increased by 14% to EUR 1,687 million (+16% at constant currency), resulting in a margin of 10.8% (Q4 2022: 9.5%). In Care Enablement, operating income decreased to EUR -67 million (FY 2022: EUR -30 million), resulting in a margin of -1.2% (FY 2022: -0.6%). Operating income excluding special items 1 improved by +16% (+19% at constant currency) to EUR 119 million, resulting in a margin of 2.2% (Q4 2022: 1.9%). Operating income for Corporate amounted to EUR -67 million (FY 2022: EUR -144 million). Operating income excluding special items 1 amounted to EUR -52 million (FY 2022: EUR -41 million).

Net income 2 increased by 35% to EUR 188 million (+41% at constant currency) in the fourth quarter 2023. Excluding special items and PRF 1 , net income 2 increased by 4% to EUR 259 million (+8% at constant currency).

In the full year 2023, net income 2 declined by 26% to EUR 499 million (-24% at constant currency). Excluding special items and PRF 1 , net income 2 increased by 4% to EUR 756 million (+6% at constant currency).

Basic earnings per share (EPS) increased by 35% to EUR 0.64 (+41% at constant currency) in the fourth quarter 2023. EPS excluding special items and PRF 1 increased by 4% to EUR 0.88 (+8% at constant currency).

In the full year 2023, EPS declined by 26% to EUR 1.70 (-24% at constant currency). Excluding special items and PRF 1 , EPS increased by 4% to EUR 2.58 (+6% at constant currency).

Strong cash flow development

Fresenius Medical Care increased its operating cash flow by 20% to EUR 719 million in the fourth quarter, resulting in a margin of 14.4% (Q4 2022: 12.0%). The increase in net cash provided by operating activities is mainly due to higher income supported by the Tricare settlement and favorable changes in working capital. In the full year 2023, operating cashflow increased by 21% to EUR 2,629 million, resulting in a margin of 13.5% (FY 2022: 11.2%).

Free cash flow 4 increased by 21% to EUR 480 million in the fourth quarter, resulting in a margin of 9.6% (Q4 2022: 8.0%). In the full year 2023, Fresenius Medical Care generated free cash flow of EUR 1,960 million, a 32% increase compared to prior year, resulting in a margin of 10.1% (FY 2022: 7.6%).

Patients, clinics and employees

As of December 31, 2023, Fresenius Medical Care treated 332,548 patients in 3,925 dialysis clinics worldwide and had 119,845 employees (headcount) globally, compared to 128,044 employees as of December 31, 2022.

Outlook 5

In 2024, Fresenius Medical Care expects revenue to grow by a low- to mid-single digit percent rate compared to prior year.

The Company expects operating income to grow by a mid- to high-teens percent rate compared to prior year.

The expected growth rates for 2024 are at constant currency, excluding special items. The 2023 basis for the revenue outlook is EUR 19,049 million and for the operating income outlook is EUR 1,540 million, both numbers are adjusted for the positive impact of the Tricare settlement and the operating business impact from divestments closed by year-end 2023.

The Company reconfirms its targets to achieve an operating income margin of 10% to 14% by 2025. This excludes impacts from portfolio changes.

https://www.freseniusmedicalcare.com/en/news/q4-2023

Grünenthal GmbH

The German company, Grünenthal GmbH, has affiliates and partners worldwide:

https://www.grunenthal.com/en/about-us/global-capabilities

Grünenthal is a global leader in pain management. Our purpose is to change lives for the better - and innovation is our passion. We're driven to seek effective, life-changing medicines and solutions for patients with severe diseases and high unmet medical needs. We are focussing all of our activities and efforts on moving towards our vision of a world free of pain.

As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to people living with pain worldwide. Strong ongoing partnerships with leading healthcare and development organisations bring our new products to life. We're a fully integrated pharmaceutical company that offers support along the entire value chain - from drug development through to commercialisation.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 29 countries across Europe, Latin America and the US. Our products are sold in more than 100 countries. In 2019, Grünenthal employed around 4,700 people and achieved sales of € 1.4 billion.

https://www.grunenthal.com/en/about-us

Grünenthal reports record revenue and profit in 2022 full-year results and strong pipeline progress

In 2022, Grünenthal generated €1.7 billion in revenues, an increase of 13 percent over prior year.

Adjusted EBITDA increased by 18 percent to €438 million and more than tripled since 2017.

Substantial pipeline advancement with two late-stage development projects in osteoarthritis and post-surgical neuropathic pain and two projects in early development focused on chronic pain and inflammatory diseases.

M&A highlights include the acquisition of Nebido™ from Bayer and the joint venture agreement with Kyowa Kirin to acquire their portfolio of established pain brands.

Aachen, Germany, 27 March 2023 - Grünenthal, the leading pharmaceutical company in pain research and management, released its 2022 full-year results, announcing record revenue and adjusted EBITDA.

The company exceeded its financial and non-financial targets, progressing on its growth path. Net revenues reached €1.7 billion, an increase of 13 percent compared to 2021. The adjusted EBITDA reached €438 million, an increase of 18 percent over 2021, and more than tripled since 2017. Grünenthal has also more than tripled its operating cash flow since 2017, positioning the company well to further invest in advancing the R&D pipeline, continuing the M&A strategy, and growing the business in the United States.

The 2022 results were driven by excellent business performance and revenues from strategic partnerships. Key brands such as Qutenza™, Palexia™, Vimovo™, and Zomig™ performed well and grew faster than the market. Qutenza™, a topical non-opioid treatment for various neuropathic pain conditions, saw a surge in demand, particularly in the U.S., where the product is indicated for treating post-herpetic neuralgia and pain related to diabetic neuropathy of the feet, a market sized ~$4,5bn.

"Grünenthal's exceptional performance in 2022 is a testament to our people and reflects the demand for better pain treatments," says Gabriel Baertschi, CEO and Chairman of the Corporate Executive Board. "Patients need better solutions to manage their pain as many current pain treatments do not provide sufficient relief or have severe side effects. We continue to invest in researching innovative, non-opioid pain medicines and ensure that more patients can benefit from our medicines. I am pleased with the progress towards our vision of a world free of pain."

In 2022, Grünenthal further advanced the investigational medicines in its research pipeline. A key priority is the development of Resiniferatoxin (RTX). The investigational treatment is being developed for treating pain in patients with knee osteoarthritis and entered clinical phase III in August 2022. A readout of the data is expected in the second half of 2024. The phase III programme aims to enable market authorisation in the E.U., U.S. and Japan by 2025/2026. The global osteoarthritis market has significant potential and is expected to grow to ~€11 billion in 2025. Grünenthal also has entered into an exclusive licensing agreement with Shionogi, who will obtain exclusive commercialisation rights for RTX in Japan. A partnership with NovaQuest Capital Management, a life science investment firm, further supports the development of the asset. NovaQuest shares the clinical development and approval risks with Grünenthal.

Grünenthal's second phase III programme investigates the use of Qutenza™ in patients with post-surgical neuropathic pain (PSNP) to support an extension of the U.S. label.

In phase I, trials are ongoing for a Nociceptin/Orphanin FQ peptide receptor (NOP) agonist. The compound is being developed to provide a non-opioid therapy option with a strong analgesic effect without the side effects commonly associated with opioids. Grünenthal also further develops its Glucocorticoid Receptor Modulator (GRM) in Phase I. The oral investigational medicine aims to provide a therapy option with broad anti-inflammatory efficacy and a more favourable benefit-risk profile than current glucocorticoid-based therapies like prednisolone.

In November 2022, Grünenthal acquired Nebido™, a leading brand for testosterone replacement therapy, from Bayer for ~€495 million. The brand immediately contributed to Grünenthal's revenue and profit as of November 2022. Another milestone in Grünenthal's M&A strategy was the announcement to enter into a joint venture agreement with Kyowa Kirin International. The joint venture includes 13 established brands with revenues primarily from pain management products. Grünenthal will own a 51 percent majority share in the new company. Grünenthal intends to acquire the remaining 49 percent share at the beginning of 2026. Since 2017, Grünenthal has closed successful acquisitions with a total expected deal value of more than €2.0 billion, including Zomig™, Nexium™, Vimovo™, Crestor™, and Nebido™.

In addition to serving patients suffering from pain, Grünenthal aims to positively impact its employees, partners, and society - while reducing the environmental footprint of its business activities. Grünenthal is a recognised leader in Environment, Social and Governance (ESG) in its industry. In July 2022, an ESG rating agency placed Grünenthal in the top 3 percent of the pharmaceutical sub-industry, acknowledging the strong management of its ESG risks.

Driving a high-performance culture is key to Grünenthal's success. Following excellent employee engagement scores during the 2022 survey, Grünenthal has 24 entities worldwide certified as a Great Place to Work®. In 2022, Grünenthal also made further progress in attracting and developing talents by launching a dedicated Diversity & Engagement strategy.

About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better, and innovation is our passion. We are focusing all our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2022, Grünenthal employed around 4,400 people and achieved sales of €1.7 bn.

https://www.grunenthal.com/en/press-room/press-releases/2023/2022-full-year-result-gruenenthal

Hartmann Group (FRA: PHH2)

The parent company of the global Hartmann Group is the German company, Paul Hartmann AG (FRA: PHH2).

The HARTMANN GROUP is one of Europe's leading providers of professional medical and care products and associated services.

We have offices in 36 countries around the world, but our products are available in over 130 countries through a network of distributors.

In a world where health is becoming an increasingly important matter and is managed more professionally, we offer our customers simple and effective solutions for the benefit of the patients. We are ambitious and constantly looking for ways to improve outcomes in both the professional sector and at home. This is expressed in our brand promise of "Helps. Cares. Protects". Our core portfolio is augmented by consumer-based medical ranges, along with care products and cosmetics.

In 2021, we employed 10,628 staff worldwide and generated sales of EUR 2,3 billion.

https://www.hartmann.info/en-corp/whoweare

Strongly increased earnings forecast for 2023 at EUR 180 to 210 million due to successful cost and productivity measures, thus slightly above previous year's level

Market and purchasing conditions continue to have a strong impact

Earnings forecast for 2023 raised significantly to EUR 180 to 210 million

January to September 2023
Organic sales growth of 2.5%
Sales increase due to necessary price adjustments
Adjusted EBITDA increased due to successful implementation of cost measures, earnings level still impacted by crises

Heidenheim, 15 Nov. 2023. The HARTMANN GROUP generated sales revenues of EUR 1,747.2 million from January to September 2023. This corresponds to organic sales growth of 2.5% compared to the same period of the previous year.

The Company generated adjusted EBITDA of EUR 147.1 million, an improvement of EUR 8.1 million compared to the same period in 2022. The adjusted EBITDA margin is 8.4%, a slight improvement on the same period in the previous year.

The Company recorded positive sales growth in Incontinence Management and Wound Care. In contrast, demand in Infection Management fell due to a further decline in the markets for protective clothing and disinfection products in particular. The Group's Complementary Divisions recorded moderate organic sales growth overall.

The Company improved its net financial status by around EUR 28 million in the third quarter (status end of September 2023: EUR -152.7 million). In addition to the improved operating business, this is also due to the optimization of inventories, whereby ensuring delivery reliability remains a high priority.

Outlook 2023

In 2023, HARTMANN launched innovative products on the market and implemented projects with substantial cost improvements. Despite a slight recovery, the additional costs for materials, energy and transport for 2023 alone are in the very high double-digit million euro range. Market conditions remain difficult, such as reduced demand markets and structural cost increases, e. g. due to higher wages.

"Our Transformation Program will contribute just under EUR 50 million to adjusted EBITDA in the current financial year, which is significantly more than planned. Investments in product innovations and production facilities as well as structural cost improvements have further increased our competitiveness and made us resilient in the current very difficult market environment," says Britta Fünfstück, CEO of the HARTMANN GROUP.

Based on the business performance to date in 2023 and current forecasts for the business outlook, HARTMANN expects to strongly exceed the previously planned earnings level for 2023 and thus slightly above the previous year's level. The Company currently anticipates adjusted EBITDA of EUR 180 to 210 million for 2023 (previously: EUR 145 to 185 million) and continues to expect moderate organic sales growth.

https://www.hartmann.info/en-corp/articles/7/4/press-release-q3-2023

Merck & Co., Inc. (NYSE: MRK, XPAR: MRK)

As a vibrant science and technology company, we believe in science as a force for good. We make a positive difference in millions of people's lives. Discover how Merck uses science to drive human progress!

Our passion for science and technology is what drives our 62,770 employees across 66 countries to find solutions to some of today's toughest challenges and create more sustainable ways to live.

We are here for people at every step, helping create, improve and prolong life. We deliver personalized treatments for serious diseases and enable people to achieve their dream of becoming parents. We empower the scientific community. Our tools, services, and digital platform make research simpler, more exact, and help to deliver breakthroughs more quickly. We provide progressive treatment solutions that help improve access to health thanks to the accuracy of our tests and the reliability of our medicine. As a company, we are at the forefront of digital living. Our science sits inside technologies that change the way we access, store, process, and display information. Our innovative technology drives human progress and opens new possibilities to transform life on Earth as we know it.

Thanks to the constant curiosity of our employees, we are making discoveries that can change the landscape of entire industries. For more than 350 years, we've been pushing the boundaries of what's possible, and we'll continue to do so in the years to come.

https://www.merckgroup.com/en/company.html

Merck to Return to Growth during Fiscal 2024

Merck expects to return to growth during fiscal 2024. This was announced by the company at today's Capital Markets Day.

19 OCT 2023 | DARMSTADT, GERMANY

Transitional year 2023 managed well so far thanks to resilient business model

Medium-term growth targets confirmed

Merck expects continued growth also beyond 2025

Geographical footprint: Close to customers with a diversified position in the economically most important regions

Merck, a leading science and technology company, expects to return to growth during fiscal 2024. This was announced by the company at today's Capital Markets Day. In addition, Merck confirmed its medium-term growth targets for its three business sectors and expects continued growth beyond 2025.

Belén Garijo, Chair of the Executive Board and CEO of Merck, said: "Merck's business model has been put to the test over and over again in previous years and proven itself resilient. Even in challenging circumstances, we see ourselves optimally positioned to continue to generate attractive growth rates in the future. Our multi-industry set-up and diversified geographic footprint enable us to leverage key megatrends - such as the growing demand for specialty medicines, novel modalities as well as artificial intelligence. We are confident that we will be able to resume our growth course in fiscal 2024."

Thanks to its set-up with three business sectors, Merck expects to see on average stable sales in fiscal 2023, despite a difficult market environment in Life Science and Electronics. The company still assumes an organic sales development of −2% to +2%, leading to net sales of € 20.5 billion to € 21.9 billion in total. In the first half of 2023, the strong growth of Healthcare largely offset the organic sales declines in Life Science and Electronics.

In fiscal 2024, Merck expects to return to organic sales growth for the Group. Several factors will contribute to this: In the Life Science business sector, the decline in Covid-19-related sales will be lower than in fiscal 2023. In the Process Solutions business unit, inventory destocking by key customers should end in early 2024, with sales starting to pick up again during the first half of the year. In Healthcare, Merck expects growth to normalize in line with medium-term aspirations. The market for semiconductor materials in the Electronics business sector is also assumed to recover incrementally in 2024.

At its Capital Markets Day, Merck confirmed its medium-term growth targets for its three business sectors. The company expects the following compound annual growth rates for organic sales development:

Life Science: 7% to 10%

Healthcare: mid-single digit percentage range

Electronics: 3% to 6%

Merck attributes this confidence in its medium-term growth potential also beyond 2025 to an optimal positioning: With its diversified portfolio, the company benefits from key megatrends. In the Life Science business sector, this includes the growing market for complex and novel modalities such as viral vectors, antibody-drug conjugates and
mRNA
.

In the Healthcare business sector, Merck develops and commercializes specialty pharmaceuticals for oncology and neurology, among others. These include the medicines Bavencio (cancer) and Mavenclad (multiple sclerosis), both of which have shown strong growth in the first half of fiscal 2023. In addition, Merck is conducting clinical trials with the pipeline assets xevinapant (head and neck cancer) as well as evobrutinib (multiple sclerosis).

With its industry-leading range of semiconductor materials, the Electronics business sector expects positive growth impetus in the medium term from the further implementation of artificial intelligence and the Internet of Things (IoT).

With regards to its geographic footprint, Merck aims to be close to local customers with an established position in the economically most important world regions. For instance, in fiscal 2022, the company generated around 35% of its sales in the Asia-Pacific region. According to
World Bank data
, this region was responsible for around 35% of global gross domestic product (GDP) in 2022. Merck is also well-positioned in other key regions. In fiscal 2022, the company generated around 29% of sales in North America, corresponding to the region's 28% share of global GDP. In 2022, Europe accounted for around 28% of Group sales and around 17% of global GDP.

Through its global footprint, Merck is also increasing its resilience and becoming less dependent on individual markets, segments and regions.

https://www.merckgroup.com/en/news/capital-markets-day-19-10-2023.html

Merz Group

The parent of the global Merz Group of companies is the German company, Merz Pharma GmbH & Co. KGaA.

In November 2019, Merz announced a new organisational structure consisting of three independently operating businesses: Merz Aesthetics, Merz Therapeutics and Merz Consumer Care.

https://www.merz.com/blog/news/merz-to-create-three-independent-customer-focused/

Merz is a global, diversified healthcare company based in Frankfurt, Germany. Privately held for more than 111 years, the company operates in the areas of aesthetics, therapeutics and consumer care and is distinguished by its commitment to innovation, long-term perspective and focus on profitable growth. In fiscal year 2018/19, Merz generated revenue of EUR 1,094 million; the company has a total workforce of 3,151 employees worldwide and a direct presence in 28 countries.

https://www.merz.com/

Merz is a privately held pharmaceutical company based in Frankfurt, Germany with affiliates across Europe, as well as the US, Canada, Mexico, Brazil and Asia Pacific. The company is active in research, development and distribution of innovative products in the areas of aesthetic medicine and neurologically induced movement disorders. In German-speaking countries, our consumer products segment, Merz Consumer Care, is a leading provider of innovative health, wellness and beauty products with its well-known tetesept ® and Merz Spezial ® brands.

https://www.merz.com/about-merz/facts-figures/

Merz is a global, family-owned aesthetics and neurotoxin company inspired by more than 110 years of innovation, commitment and trust. Driven by the opportunity to help people look better, feel better and live better, Merz earns the confidence of clinicians in aesthetics and neuroscience with a relentless focus on customer service to providers and overall satisfaction for patients.

As a family-owned company, Merz values personal relationships; we recognize that our obligation is to understand the needs of our physician customers, so we can help them best serve their patients. You see it in how we engage with our customers in every aspect of our business. You see it in our holistic portfolio of products. And you'll see it in the innovations that are already expanding that portfolio.

From our scientific expertise developed over more than a century, to our focus on customer needs, the Merz way means your success is our success.

https://www.merz.com/about-merz/

MorphoSys AG (FRA: MOR, NASDAQ: MOR)

MorphoSys (FSE & NASDAQ: MOR) is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 29 are currently in clinical development. In 2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys's antibody technology to receive regulatory approval. The Company's most advanced proprietary product candidate, tafasitamab (MOR208), has been granted U.S. FDA breakthrough therapy designation for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has approximately 370 employees.

https://www.morphosys.com/company

MorphoSys AG Reports First Nine Months and Third Quarter 2023 Financial Results

Phase 3 MANIFEST-2 topline results expected by the end of November, with detailed findings in oral presentation at ASH 2023

Monjuvi® U.S. net product sales of US$ 23.4 million (€ 21.5 million) for the third quarter of 2023

U.S. FDA granted Fast Track designation for tulmimetostat in ARID1A-mutated endometrial cancer

€ 642.2 million in cash and other financial assets as of September 30, 2023

Conference call and webcast (in English) tomorrow, November 16, 2023, at 2:00 pm CET (1:00 pm GMT/8:00 am ET)

MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the third quarter and the first nine months of 2023.

"With pelabresib, MorphoSys has the potential to meaningfully improve upon current first-line treatments for patients with myelofibrosis. We look forward to showcasing the topline results of our pivotal MANIFEST-2 study by the end of November and, shortly thereafter, in our detailed oral presentation at ASH 2023," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "Sales of Monjuvi remain on track for its approved indication, allowing us to narrow our full-year 2023 guidance target. Our mid- to late-stage pipeline offers promising value-creating opportunities, with two additional pivotal studies expected to read out over the next two years."

Monjuvi/Minjuvi ® Highlights:

Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 23.4 million (€ 21.5 million) for the third quarter 2023 (Q3 2022: US$ 22.2 million (€ 21.9 million)) and US$ 67.8 million (€ 62.6 million) for first nine months 2023 (9M 2022: US$ 64.1 million (€ 60.2 million)).

Minjuvi royalty revenue of € 1.2 million for sales outside of the U.S. in the third quarter 2023 and € 4.1 million for the first nine months of 2023.

Conference Highlights:

Topline results from the Phase 3 MANIFEST-2 trial of pelabresib, an investigational BET inhibitor, in combination with the JAK inhibitor ruxolitinib in JAK inhibitor-naïve adult patients with myelofibrosis are expected by the end of November.

Following the release of the topline MANIFEST-2 study results, detailed findings from the study will be presented during an oral session on Sunday, December 10, 2023, at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, USA. During ASH 2023, MorphoSys will host an in-person investor event with the company's management team and medical experts to review the detailed study findings. The event, taking place on Monday, December 11, at the Hilton Bayfront Hotel, will start with a networking breakfast at 6:30 a.m. PST and continue with a formal presentation at 7:00 a.m. PST (10:00 a.m. EST / 4:00 p.m. CET). A webcast will also be available for those not attending the Annual Meeting in person, accessible on the Investors section of MorphoSys' website (www.morphosys.com).

Beyond the MANIFEST-2 study, seven additional abstracts on pelabresib and tafasitamab were accepted for presentation and publication at ASH 2023.

Tulmimetostat Highlight:

In September 2023, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for tulmimetostat, an investigational next-generation dual inhibitor of EZH2 and EZH1, for the treatment of patients with advanced, recurrent or metastatic endometrial cancer harboring AT-rich interacting domain containing protein 1A (ARID1A) mutations and who have progressed on at least one prior line of treatment.

Events After the End of the Third Quarter of 2023:

MorphoSys updated its financial guidance for 2023 financial year on October 25, 2023.

Financial Results for the Third Quarter of 2023 (IFRS):

Total revenues for the third quarter 2023 were € 63.8 million compared to € 95.8 million for the same period in 2022. The decrease resulted from lower revenues from licenses compared to prior year.

in € million*
Q3 2023
Q2 2023
Q3 2022
Q-Q Δ
Y-Y Δ
Total revenues
63.8
53.2
95.8
20 %
(33) %
Monjuvi product sales
21.5
21.7
21.9
(1) %
(2) %
Royalties
34.0
26.8
29.7
27 %
14 %
Licenses, milestones and other
8.3
4.6
44.1
80 %
(81) %
* Differences due to rounding.

Cost of Sales: In the third quarter of 2023, cost of sales was € 15.1 million compared to € 8.1 million for the comparable period in 2022.

Research and Development (R&D) Expenses: In the third quarter 2023, R&D expenses were € 63.2 million (Q3 2022: € 77.8 million). The decrease mainly resulted from lower expenses for external services.

Selling, General and Administrative (SG&A) Expenses: Selling expenses in the third quarter 2023 were € 19.9 million (Q3 2022: € 23.5 million). The selling expenses decreased due to streamlining and focusing of selling efforts. General and administrative (G&A) expenses amounted to € 15.0 million (Q3 2022: € 15.6 million).

Impairment of Goodwill: In the third quarter 2023, an impairment of goodwill in the amount of € 1.6 million was recorded, which initially resulted from an acquisition in financial year 2010 (Q3 2022: € 0.0 million).

Operating Loss: Operating loss amounted to € 51.0 million in the third quarter 2023 (Q3 2022: operating loss of € 29.3 million).

Consolidated Net Loss: For the third quarter 2023, consolidated net loss was € 119.6 million (Q3 2022: consolidated net loss of € 122.9 million).

Financial Results for the first nine months 2023 (IFRS):

Revenues for the first nine months of 2023 were € 179.3 million (9M 2022: € 196.7 million). The decrease resulted from lower revenues from licenses compared to prior year. Revenues include € 62.6 million from the recognition of Monjuvi product sales in the U.S. Royalties in the first nine months 2023 included € 4.1 million from the sale of Minjuvi outside of the U.S. by our partner Incyte and € 78.3 million from Tremfya ® sales which is fully passed on to Royalty Pharma.

in € million*
9M 2023
9M 2022
Y-Y Δ
Total revenues
179.3
196.7
(9) %
Monjuvi product sales
62.6
60.2
4 %
Royalties
82.4
70.8
16 %
Licenses, milestones and other
34.2
65.6
(48) %
* Differences due to rounding.

Cost of Sales: For the first nine months of 2023, cost of sales were € 43.8 million compared to € 33.2 million in 2022. The increase was primarily driven by higher sales of Monjuvi in the U.S. and Minjuvi outside of the U.S.

R&D Expenses: In the first nine months of 2023, R&D expenses were € 203.3 million compared to € 203.8 million in 2022.

SG&A Expenses: Selling expenses decreased in the first nine months of 2023 to € 58.8 million compared to € 69.4 million in 2022. The selling expenses decreased due to streamlining and focusing of selling efforts. G&A expenses amounted to € 42.9 million compared to € 42.6 million in the first nine months of 2022.

Impairment of Goodwill: In the first nine months of 2023, an impairment of goodwill in the amount of € 1.6 million was recorded, which initially resulted from an acquisition in financial year 2010 (9M 2022: € 0.0 million).

Operating Loss: Operating loss amounted to € 171.1 million in the first nine months of 2023 compared to an operating loss of € 152.3 million in 2022.

Consolidated Net Loss: For the first nine months of 2023, consolidated net loss was € 238.0 million compared to a net loss of € 480.5 million in 2022.

Cash and Other Financial Assets: As of September 30, 2023, the Company had cash and other financial assets of € 642.2 million compared to € 907.2 million on December 31, 2022.

Number of shares: The number of shares issued totaled 34,231,943 on September 30, 2023, no change compared to December 31, 2022.

Updated Full Year 2023 Financial Guidance:

The updated financial guidance was issued on October 25, 2023.

Updated 2023 Financial Guidance
Previous 2023 Financial Guidance*
2023 Guidance Insights
Monjuvi U.S. net product sales
US$ 85m to 95m
US$
80m to 95m
100% of Monjuvi U.S. net product sales are recorded on MorphoSys' income statement and related profit/loss is split 50/50 between MorphoSys and Incyte.
Gross margin for Monjuvi U.S. net product sales
Approx. 75%
75% to 80%
100% of Monjuvi U.S. product cost of sales are recorded on MorphoSys' income statement and related profit/loss is split 50/50 between MorphoSys and Incyte.
R&D expenses
€ 290m to 315m
€ 290m to 315m
2023 anticipated to be incrementally higher than 2022 due to the expansion of the pelabresib development program.
SG&A expenses
€ 140m to 155m
€ 140m to 155m
45% to 50% of mid-point of SG&A expenses represent Monjuvi U.S. selling costs of which 100% are recorded in MorphoSys' income statement. Incyte reimburses MorphoSys for half of these selling expenses.

*The Previous Financial Guidance 2023 was initially provided on January 5, 2023.

Additional information related to 2023 Financial Guidance:

Tremfya ® royalties will continue to be recorded as revenue without any cost of sales in MorphoSys' income statement. These royalties, however, will not contribute any cash to MorphoSys, as 100% of the royalties will be passed on to Royalty Pharma.

MorphoSys anticipates receiving royalties for Minjuvi sales outside of the U.S.

MorphoSys does not anticipate any significant cash-accretive revenues from the achievement of milestones in 2023.

MorphoSys anticipates sales of commercial and clinical supply of tafasitamab outside of the U.S. to its partner Incyte. Revenue from this supply is recorded in the "Licenses, milestones and other" category in MorphoSys' income statement. These sales result in a zero gross profit/margin. MorphoSys does not provide guidance for these sales.

Operational Outlook:

The following events and development activities are upcoming and planned for 2024 and beyond:

Topline results for the pivotal Phase 3 study (MANIFEST-2) of pelabresib in myelofibrosis (MF) are expected by the end of November;

Primary analysis data from the Phase 3 study (inMIND) of tafasitamab in patients with indolent lymphoma (r/r FL/MZL) in 2024;

Primary analysis data from the pivotal Phase 3 study (frontMIND) of tafasitamab in previously untreated DLBCL in the second half of 2025.

MorphoSys Group Key Figures (IFRS, end of the third quarter: September 30, 2023)

in € million
Q3 2023
Q3 2022
Δ
9M 2023
9M 2022
Δ
Revenues
63.8
95.8
(33) %
179.3
196.7
(9) %
Product Sales
21.5
21.9
(2) %
62.6
60.2
4 %
Royalties
34.0
29.7
14 %
82.4
70.8
16 %
Licenses, Milestones and Other
8.3
44.1
(81) %
34.2
65.6
(48) %
Cost of Sales
(15.1)
(8.1)
86 %
(43.8)
(33.2)
32 %
Gross Profit
48.7
87.7
(44) %
135.5
163.5
(17) %
Total Operating Expenses
(99.7)
(117.0)
(15) %
(306.6)
(315.8)
(3) %
Research and Development
(63.2)
(77.8)
(19) %
(203.3)
(203.8)
0 %
Selling
(19.9)
(23.5)
(15) %
(58.8)
(69.4)
(15) %
General and Administrative
(15.0)
(15.6)
(4) %
(42.9)
(42.6)
1 %
Impairment of Goodwill
(1.6)
—
n/a
(1.6)
—
n/a
Operating Profit / (Loss)
(51.0)
(29.3)
74 %
(171.1)
(152.3)
12 %
Other Income
2.1
10.6
(80) %
4.9
19.8
(75) %
Other Expenses
(0.8)
(7.5)
(89) %
(3.1)
(23.0)
(87) %
Finance Income
(22.5)
70.3
>(100)%
39.1
87.1
(55) %
Finance Expenses
(44.6)
(167.5)
(73) %
(101.2)
(415.4)
(76) %
Income from Reversals of Impairment Losses / (Impairment Losses) on Financial Assets
0.0
0.6
(100) %
0.6
(0.4)
>(100)%
Share of Loss of Associates accounted for using the Equity Method
(2.3)
(0.3)
>100%
(6.6)
(0.3)
>100%
Income Tax Benefit / (Expenses)
(0.5)
0.1
>(100)%
(0.5)
4.1
>(100)%
Consolidated Net Profit / (Loss)
(119.6)
(122.9)
(3) %
(238.0)
(480.5)
(50) %
Earnings per Share, Basic and Diluted (in €)
(3.50)
(3.60)
(3) %
(6.97)
(14.07)
(50) %
Cash and other financial assets (end of period)
642.2
907.2 *
(29) %
642.2
907.2 *
(29) %

* Value as of December 31, 2022

https://www.morphosys.com/en/news/morphosys-ag-reports-first-nine-months-and-third-quarter-2023-financial-results

Rhön-Klinikum AG (XETR: RHK)

RHÖN‐KLINIKUM AG is one of the largest healthcare providers in Germany. The hospital group offers excellent medical care with a direct link to universities and research institutes. More than 860,000 patients are treated every year at the five group hospitals located in Bad Berka, Bad Neustadt, Frankfurt (Oder), Giessen and Marburg where more than 17,000 employees work. We have now put our ideal RHÖN healthcare campus concept into practice at our site in Bad Neustadt. It provides fully comprehensive forward-looking healthcare, thus crossing sectoral boundaries. The patient-orientated concept takes account of the increasing importance of out-patient medical services and raises modern healthcare in rural areas to a new level of excellence.

https://en.rhoen-klinikum-ag.com/

RHÖN-KLINIKUM AG publishes result for first half of 2023 - outlook confirmed

10 August 2023

RHÖN-KLINIKUM AG closed the first half of 2023 with a 2.4 per cent increase in revenues to 728.2 million euros (2022: 711.2 million euros). From January to June 2023 a total of 446,022 patients were treated on an inpatient and outpatient basis in the hospitals and medical care centres of RHÖN-KLINIKUM AG, 4.4% more compared with the same period of the previous year (2022: 427,344).

At 45.2 million euros, EBITDA fell short of the previous year's level (2022: 52.8 million euros). Materials and consumables used increased as a result of higher purchasing prices to 237.0 million euros (2022: 214.0 million euros). Taking account of depreciation/amortisation, financing costs and taxes, EBITDA results in a consolidated profit of 12.2 million euros (2022: 12.8 million euros).

The key figures of the first six months are influenced by two main developments: on the one hand, by the still persisting inflation, coping with the impacts of higher energy and commodity prices, as well as the geopolitical risks brought about by the war in Ukraine. On the other hand, by a weekslong strike at Universitätsklinikum Gießen und Marburg (UKGM) early this year, which resulted in massive cuts in outpatient and inpatient care.

Now that UKGM and the trade union ver.di on 14 April 2023 reached agreement on a key issues paper for the conclusion of a "job protection and relief collective agreement for UKGM and UKGM Service GmbH", efforts are now successfully being turned towards overcoming the economic consequences of the strike.

This will enable us to seize the opportunities arising from an agreement signed at the end of February 2023 between the Federal State of Hesse, the Universities of Giessen and Marburg, Universitätsklinikum Gießen und Marburg (UKGM) and RHÖN-KLINIKUM AG on UKGM's entitlement to investment funding. After RHÖN-KLINIKUM AG already in the past had invested over 750 million euros at UKGM from own funds, the next ten years will now see further amounts totalling nearly 850 million euros being invested in healthcare delivery, research and teaching. At the same time, federal state funding totalling roughly 529 million euros coupled with investments of roughly 319 million euros from own funds will enable the two hospitals to keep pace with medical, technical and structural developments in order to continue providing cutting-edge university medical care also in future.

Outlook

For the current financial year 2023 we continue to expect revenues of 1.5 billion euros within a range of +/- 5 per cent. For earnings before interest, tax and depreciation/amortisation (EBITDA), we expect a level of between 103 million euros and 109 million euros.

The outlook is further subject to considerable uncertainties in connection with the geopolitical risks brought about by the war in Ukraine and any regulatory measures impacting our remuneration structure in 2023.

https://en.rhoen-klinikum-ag.com/press/press-releases/news/article/rhoen-klinikum-ag-publishes-result-for-first-half-of-2023-outlook-confirmed.html

STADA Group

The parent of the global STADA Group is the German company, STADA Arzneimittel AG.

Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. All significant companies with a STADA share of at least 50% have been listed.

https://www.stada.com/about-stada/stada-worldwide

The STADA Group

At STADA, we follow our purpose of "Caring for People's Health as a Trusted Partner". In pursuit of this purpose, we are committed to further accelerating the successful trajectory of our company.

STADA is a leading manufacturer of high-quality pharmaceuticals. With a long-standing heritage rooted in pharmacies, we are perceived as a reliable and trustworthy partner for more than 125 years. With our products we help people protect and regain a dignified and able life. With our proven Generics, we ensure that everyday health remains affordable. To our employees, we offer an attractive working environment in which they can develop personally.

STADA focuses on a three-pillar strategy consisting of consumer healthcare products, generics, specialty pharmaceuticals. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. Consumer Healthcare brands such as Zoflora®, Snup®, Nizoral® and Grippostad® are among the top sellers in their respective product categories. In financial year 2022, STADA achieved group sales of EUR 3,797.2 million and reported earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 884.7 million. As of 31 December 2022, STADA employed 13,183 people worldwide.

https://www.stada.com/about-stada/who-we-are

https://www.stada.com/

STADA's excellent results in H1 2023 indicate a record annual profit of €1 bn, driven by Consumer Healthcare and Specialty - 15/8/2023

Double-digit growth journey continues with 16% sales increase to €2.1bn 1 and 30% EBITDA to €509 million 1 in first six months of 2023

Organic growth in Consumer Healthcare is largest contributor to record performance; Specialty segment with double-digit growth as well. Market-share gains in Generics

STADA CEO Peter Goldschmidt: "STADA's purpose, values and strategy are the base for our continued double-digit growth in sales and earnings. With this momentum, we are well on track to exceed over €4 billion sales and €1 billion EBITDA this year."

Bad Vilbel - 15 August 2023 - STADA continued its track record of double-digit sales and profit growth during the first half of 2023. The best half-year results to date were driven by above-market performance across STADA's three strategic business segments: Consumer Healthcare, Generics and Specialty Pharmaceuticals. All regions contributed to the sales and profit development.

Group sales increased by 16% to €2.1 billion 1 while earnings (EBITDA) improved by 30% to €509 million 1 in the first six months of 2023. H1 is another proof point for STADA's continuous growth. The company almost doubled its profits in the past five years.

"STADA's purpose, values and strategy are the base for our continued double-digit growth in sales and earnings. With this momentum, we are well on track to exceed over €4 billion sales and €1 billion EBITDA this year," commented CEO Peter Goldschmidt. "Our unique culture and superior employee engagement drives our performance. With the good results of H1 and our strong pipeline, we continue our successful growth journey. Furthermore, our sustainability rating confirms that we are among the top 15% of pharmaceutical companies according to an independent ESG assessment," Goldschmidt continued.

STADA's purpose, values and strategy are the base for our continued double-digit growth in sales and earnings. With this momentum, we are well on track to exceed over €4 billion sales and €1 billion EBITDA this year.

PETER GOLDSCHMIDT

CEO, STADA

Major milestones achieved in supporting patient access to medicines

During the first half of 2023, STADA achieved major milestones in supporting patient access to the medicines they need. The US Food and Drug Administration cleared exports of the biological drug substance epoetin to the US from a company facility in Uetersen, Germany. At around the same time, authorities in the European Union confirmed that the new factory in Tuy Hòa, Vietnam, complies with stringent European good manufacturing practice (GMP) standards which opens up exports to Europe for continued supply reliability. Meanwhile, construction on the supply-chain hub in Turda, Romania, is progressing well; with an investment of more than €50 million this will also add to the substantial capacity of STADA's supply-chain network in Europe.

Through initiatives such as photovoltaic cells in Vietnam and industry-leading design concepts in Turda, STADA continues to advance its contribution to the sustainable supply of medicines. An improvement in reducing STADA´s risk rating from 26.7 in the first half of 2022 to 21.6 in the first six months of this year was issued by the independent Sustainalytics agency. The forthcoming publication of the group's second Global Sustainability Report will highlight in detail numerous environmental, social and governance initiatives around the world.

In September the group will also unveil the results of its 2023 STADA Health Report - the ninth since publication began. This unique survey with more than 32,000 participants across 16 countries will provide valuable insights into the physical and mental health and wellbeing of the population. In doing so, STADA is closely aligned with the United Nations Sustainable Development Goal 3 on Good Health and Wellbeing while delivering on STADA's purpose of Caring for People's Health as a Trusted Partner.

Three strategic business segments drive consistent growth

In the area of Consumer Healthcare several launches and line extensions, coupled with successful integration of recent acquisitions, propelled a 19% adjusted increase to €870.6 million sales in the first half of 2023. Having outperformed the market in several product categories, Consumer Healthcare was the largest of STADA's three strategic business segments, accounting for 42% of group turnover. Gaining share in an expanding market was augmented by many new product offerings, recent business development activities, such as distribution agreements for Sanofi's entire consumer healthcare portfolio in around 30 European and Eurasian countries 2 . STADA's status as a go-to-partner in consumer healthcare was further confirmed by the announcement in mid-July this year of the acquisition of another basket of brands from Sanofi, including Antistax, Lomudal, Omnivit and Opticrom eye drops 3 .

In the field of Generics, launches including the anticoagulant apixaban in countries such as the UK, the diabetes drug sitagliptin in several European markets, the antiparasitic agent permethrin and the pain-reliever tapentadol contributed to STADA's adjusted sales advancing by 8% to €756.2 million in the first half of 2023. Generics accounted for 37% of group sales. Consistent supply reliability through investment in strong inventory levels, internal capacity building and dual sourcing of active ingredients enabled STADA to step in to meet demand. This resulted in STADA outperforming the market and capturing retail share in several countries. Market-share gains were made in numerous countries, including Austria, Bulgaria, Croatia, Denmark, France, Lithuania, Romania, Serbia, Slovenia and Switzerland. Several launches in therapeutic categories such as cardiovascular and diabetes added to above-market growth.

Specialty sales are ahead by 24% on an adjusted basis to €432.1 million in the first half of this year and made up 21% of group sales. During the first half of 2023, STADA's Specialty business achieved another milestone with the entry into Europe's ophthalmology market by introducing Ximluci, a biosimilar alternative to the reference brand Lucentis, in several countries, including in Germany and the UK. Ximluci is STADA's sixth marketed biosimilar, with previous launches such as Hukyndra (adalimumab) continuing to gain traction and support patient access in more countries. The Movymia (teriparatide) osteoporosis therapy continues to lead the biosimilars market, while work continues towards bringing the next biosimilar candidate in the pipeline, ustekinumab, to market.

A further milestone was reached in that more than 1,000 patients are now being treated with STADA's Lecigon pump combining three proven active ingredients for late-stage Parkinson's disease which has recently been launched in further countries including Bulgaria, Ireland, Spain and Switzerland. In nephrology, the first EU-approved treatment for the rare, chronic and debilitating kidney disease IgA nephropathy, Kinpeygo, is reaching more patients, and work continues on bringing this therapeutic option to more countries across Europe.

Strong basis for consistent, sustainable growth

STADA has a rich pipeline across Generics and Specialty/Biosimilars as well as Consumer Healthcare products that will contribute strongly to the net sales development until 2030. A constant flow of new products feeds the commercialization engine and ensures future growth. Resources are reallocated, assets in the group leveraged, and a much bolder and more focused approach to licensing and acquiring high-potential products is taken.

The group can build on strong capabilities in small-molecule development enabling cost leadership and is generally agnostic as to whether these products are developed externally or internally. In fact, one of the benefits of commercial agility is that the group can close attractive product deals more easily being a partner of choice for Europe. Since 2017, STADA has invested in building a global BD&L team, hiring more than 20 experienced BD&L leaders with dedicated regional responsibility and expertise - resulting in an industry-leading close to 100 BD&L deals per year in the recent past.

"STADA's bright future is once again confirmed by our strong H1 results with double-digit growth in sales and earnings. Our purpose and values are the base for our top employee engagement results, leading to agile implementation of our strategy with above market growth in Consumer Healthcare, Specialty and Generics," Goldschmidt summarized.

https://www.stada.com/blog/posts/2023/august/stadas-excellent-results-in-h1-2023-indicate-a-record-annual-profit-of-1-bn-driven-by-consumer-healthcare-and-specialty

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