Press Release // May 17, 2022

United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) grants Marketing Authorization for FYB201, Formycon’s Biosimilar for Lucentis®¹, to be Commercialized by Teva as ONGAVIA^®

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce, that today the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization (MA) in the United Kingdom (“UK”) for FYB201, a biosimilar to Lucentis® (ranibizumab). Teva Pharmaceutical Industries Ltd. (“Teva”) will serve as the exclusive commercial partner and will market the biosimilar under the brand name ONGAVIA® throughout the UK.

Lucentis® is used in the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases like visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV). It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

The MHRA approval is based on a totality of evidence including analytical, clinical and manufacturing data. In a randomized, double-masked, parallel group, multicenter phase III study, the efficacy, safety, pharmacokinetics and immunogenicity of FYB201/ONGAVIA® was proven comparable to the reference drug Lucentis® (ranibizumab) in patients with age-related neovascular (wet) macular degeneration (nAMD).

Dr. Stefan Glombitza, COO of Formycon comments: “Retinal diseases are an increasing burden for patients worldwide. We are pleased to announce the approval of our Lucentis® biosimilar in UK, creating a treatment option for some of the most common and serious retinal diseases.”

The commercial launch of FYB201/ONGAVIA® in the UK by Teva Pharmaceutical Industries Ltd. (“Teva”), which has licensed the distribution rights from Bioeq under an exclusive strategic partnership, is expected to follow as soon as possible and targets to be the first available Biosimilar for Lucentis® in Europe.

¹⁾Lucentis® is a registered trademark of Genentech Inc.

About Formycon:
Formycon (ISIN: DE000A1EWVY8 / WKN: A1EWVY) is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207.

About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses and commercializes biosimilars. www.bioeq.ch

About Teva:
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.

Contact:
Sabrina Müller
Senior Manager Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 – 86 46 67 149
fax + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com

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

Publication of insider information in accordance with Article 17 of the Regulation (EU) No 596/2014 Ad Hoc Announcement // May 17, 2022

FYB201, Formycon’s Biosimilar for Lucentis®¹ achieves Marketing Authorization in United Kingdom

Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce, that today the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization (MA) in the United Kingdom (“UK”) for FYB201, a biosimilar to Lucentis® (ranibizumab).

Lucentis® is used in the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

The commercial launch of FYB201 in the UK by Teva Pharmaceutical Industries Ltd. (“Teva”), which has licensed the distribution rights from Bioeq under an exclusive strategic partnership, is expected to follow as soon as possible. FYB201 will be marketed in the UK under the brand name ONGAVIA® and targets to be the first available Biosimilar for Lucentis® in Europe.

¹⁾Lucentis® is a registered trademark of Genentech Inc.

About Formycon:
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. Formycon AG is listed in the Open Market (“Scale”) of the Frankfurt Stock Exchange (ISIN: DE000A1EWVY8 / WKN: A1EWVY).

About Biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.

Contact:
Sabrina Müller
Senior Manager Corporate Communications and Investor Relations
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg/Germany
phone +49 (0) 89 – 86 46 67 149
fax + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com

• PARTNERSHIP LEVERAGES IPSC-BASED BETA CELLS FROM EVOTEC’S QRBETA INITIATIVE COMBINED WITH SERNOVA’S PROPRIETARY IMPLANTABLE CELL POUCH™ DEVICE
• THE GOAL IS THE DEVELOPMENT AND COMMERCIALISATION OF AN OFF-THE-SHELF BETA CELL REPLACEMENT THERAPY FOR INSULIN-DEPENDENT DIABETES
• EVOTEC MAKES STRATEGIC € 20 M EQUITY INVESTMENT IN SERNOVA
• EVOTEC/SERNOVA JOINT CONFERENCE CALL AND WEBCAST AT 8.30 AM EDT MAY 17, 2022

Hamburg, Germany, and London, ON, Canada, 17 May 2022:
Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Sernova Corp. (TSX-V: SVA; OTCQB: SEOVF; FSE: PSH), a clinical-stage company and leader in regenerative medicine cell therapeutics today announced a partnership in the field of diabetes. Both Companies will leverage their respective strengths to develop an implantable iPSC-based beta cell replacement therapy for the treatment of insulin-dependent diabetes, including type 1 and 2.

The partnership leverages iPSC-based beta cells from Evotec’s QRbeta initiative. Evotec reliably produces human iPSC-based beta cells in islet-like clusters in a quality controlled (“QC”) scalable bioreactor process. Those islet-like clusters are functionally equivalent to primary human islets in their ability to normalise blood glucose levels in in vivo models over several months.

Evotec’s iPSC-based beta cells will be combined with Sernova’s proprietary Cell Pouch™, which is the leading implantable and scalable medical device in its class. In particular, it enables vascularisation of the cell implant and thus ensures long-term survival and optimal function in patients. The combination of primary donor islets and Cell Pouch has achieved long-lasting therapeutic results in patients enrolled in Sernova’s US-based Phase I/II clinical trial, including sustained insulin-independence in high-risk Type 1 Diabetes patients who previously required insulin injections for survival. Moreover, Sernova will evaluate local immune protection technology to protect non-modified beta cells and avoid the requirement for immunosuppressive treatment. The goal of the partnership is the development of an off-the-shelf iPSC-based beta cell replacement therapy device for the treatment of patients living with insulin-dependent diabetes.

Sernova has acquired an option for an exclusive global license to Evotec’s Induced Pluripotent Stem Cell (iPSC)-based Beta cells for use with its Cell Pouch system to treat diabetes. From an operational perspective, the pre-clinical development programme(s) will be jointly funded until IND acceptance. Sernova has the right to exercise its option for an exclusive global license upon IND filing. Evotec will contribute cell manufacturing through commercialisation and decide in the future on joint funding of clinical development. Upon commercialisation, there will be a profit-sharing arrangement between the two companies, with the split dependent upon Evotec’s participation in the clinical development programme.

In conjunction with the agreement, Evotec has committed to a strategic € 20 m equity investment in Sernova (approx. CAD$ 27 m at an €/CAD$ fx rate of 1.355).

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We searched long and hard for the right partner. Sernova clearly ticks all boxes with their clinically validated Cell Pouch™ technology, which fits perfectly to Evotec’s iPSC-based beta cells. Together we will progress a highly differentiated first-in-class beta cell therapy into clinical development with the common goal to bring a truly transformative therapy to insulin-dependent diabetic patients. The operational synergies of Evotec’s and Sernova’s technologies puts Sernova in position to become the world’s leader in beta cell replacement therapy. Our equity investment underlines our strategic interest in this collaboration with Sernova. We are very much looking forward to collaborate with them on the project as well as to be part of their Supervisory Board.”

Dr Philip Toleikis, President, and Chief Executive Officer of Sernova, commented: “In tandem with our current clinical islet cell programme, Sernova entered into multiple pharmaceutical research collaborations to identify the highest quality and most compatible iPSC cell technology, and validate the cells pre-clinically within our Cell Pouch System. Evotec is an iPSC powerhouse having dedicated many years and substantial resources to developing high quality and stable stem cell technologies for multiple therapeutic applications. In every sense, both as a global strategic partner and as an iPSC expert, Evotec has exceeded all our expectations and we welcome them to join our advisory board. Today’s announcement of this joint iPSC beta-cell partnership completes the three pillars of our diabetes cell therapy platform. Alongside our clinically validated Cell Pouch System and recently acquired conformal coating immune protection technology, this now establishes a total regenerative medicine cell therapy solution for insulin-dependent diabetes.”

Sernova and Evotec are going to hold a joint conference call on the transaction. The conference call will be held in English.

Conference call details

Date: Tuesday, 17 May 2022
Time: 02.30 pm CEST (08.30 am EDT, 01.30 pm BST)

US Toll Free: 1-877-704-4453
International: 1-201-389-0920
Conference ID: 13730121

A simultaneous slide presentation will be available under the following link: https://viavid.webcasts.com/starthere.jsp?ei=1550130&tp_key=3de87cce1d

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

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

About Sernova Corp and the Cell Pouch System cell therapy platform
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin- dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body.

The Cell Pouch, as part of the Cell Pouch System, is a proprietary, scalable, implantable macro- encapsulation device solution designed for the long-term survival and function of therapeutic cells. After implantation, the device incorporates with tissue, forming highly vascularised, native tissue chambers for the transplantation and function of therapeutic cells, that release proteins and hormones as required to treat disease.

The Cell Pouch, along with therapeutic cells, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans in a Canadian first-in-human study. Sernova is currently conducting a Phase I/II clinical trial study at the University of Chicago. Encouraging interim results have been presented at several international scientific conferences.

For more information, please visit www.sernova.com.

About Diabetes
Diabetes mellitus (“diabetes”) is a chronic incapacitating disease associated with severe lifelong conditions which require intensive monitoring and control, such as cardiovascular diseases, kidney diseases, nerve damage and eye diseases. At present, there is no cure for diabetes and only symptomatic treatment options are available. According to the International Diabetes Federation, it is estimated that 537 million people worldwide suffered from diabetes in 2021 (2019: 463 million) and this number is projected to reach 643 million by 2030. The disease is a major burden to the global healthcare systems with about $ 966 bn being spent on the treatment of diabetes in 2021 and it is projected that expenditure will reach $ 1.03 tn by 2030.

About Beta Cells
Beta cells play a key role in the pathogenesis of diabetes. Beta cells reside in clusters of hormone producing cells (“islets”) within the pancreas. They respond to elevated blood glucose levels (e.g. after a meal) by secreting the glucose lowering hormone insulin. In the type 1 form of diabetes (“T1D”), beta cells are destroyed by the patient’s own immune system. As a result, T1D patients must follow a life-long regimen of carefully dosed insulin injections. In patients with type 2 diabetes (“T2D”), beta cells are functionally impaired and yet have to work in the presence of metabolic stress and increased workload due to an impaired tissue insulin response. T2D is progressive, and current therapeutic options cannot prevent the deterioration of beta cell function, eventually also creating a need for insulin injections. Despite the fact that insulin treatments are important and widely used for people with diabetes, they cannot fully mimic the normal control of blood glucose levels by normal beta cells necessary to avoid acute and long-term complications of diabetes. There is a critical medical need for novel therapeutic options which can restore beta cell mass and, thereby, reduce or eliminate the need for insulin injections. Furthermore, beta cell replacement therapy also has the potential to prevent or reverse the decline in beta cell function in type 2 diabetes.

ABOUT EVOTEC SE
Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 4,200 highly qualified people. The Company’s 15 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on Twitter @Evotec and LinkedIn.

FORWARD-LOOKING STATEMENTS
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

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

IR Contact Evotec SE:
Volker Braun, SVP Head of Global Investor Relations & ESG, Phone: +49.(0)40.56081-775, volker.braun@evotec.com

PharmaSGP: Another revenue record – Q1 2022 revenues up 67% year-on-year

Gräfelfing, 17 May 2022 – In the first quarter of 2022, German OTC pharmaceutical company PharmaSGP Holding SE continued its dynamic growth path of the previous quarters and achieved another revenue record of € 20.6 million on the basis of preliminary, unaudited results. This corresponds to growth of 67% (previous year: € 12.4 million). According to plan, PharmaSGP intensified its marketing activities in the first quarter, especially in order to leverage the full potential of the portfolio acquired from the GlaxoSmithKline Group. Adjusted earnings before interest, taxes, depreciation and amortization (adjusted EBITDA) amounted to € 5.0 million for the first three months of 2022, representing a year-on-year growth of 135%. The adjusted EBITDA margin also rose year-on-year to 24.3%, as expected (previous year: 17.2%).

CEO Natalie Weigand comments: “Our first-quarter revenue growth impressively demonstrates the potential we can leverage via our platform, both with existing brands and with newly acquired brands. As soon as we had acquired GSK’s portfolio in the fall of 2021, we implemented our D2C marketing strategy in order to tap unexploited sales opportunities. In the meantime, the integration of the portfolio has been successfully completed and we have launched new products under the Baldriparan^® and Kamol^® brand families in our core markets. We regard this development as full confirmation of our focus on selective M&A activities and we will continue to pursue this path with rigor in 2022.”

“After a very strong performance during 2021, we see PharmaSGP fully on track after the first quarter for a further record year in 2022 and the achievement of our guidance,” added CFO Michael Rudolf. “So we anticipate nothing less than a renewed acceleration along our profitable growth track in 2022 – a view also shared by analysts covering our company.”

For the 2022 financial year, revenues are expected to grow by at least 19.5% to between € 78 million and € 82 million. The adjusted EBITDA margin is expected to increase year-on-year to reach a level between 30% and 33%. This corresponds to adjusted EBITDA in a range between € 23.4 and 27.1 million.

PharmaSGP will publish its full report for the first quarter of 2022 on 31 May 2022.
 

OVERVIEW OF PRELIMINARY YEAR-ON-YEAR FIGURES

CONTACT

cometis AG
Claudius Krause
Phone: 49-611-20585528
Email: ir@pharmasgp.com

ABOUT PHARMASGP HOLDING SE

PharmaSGP is a leading consumer health company with a diversified portfolio of over-the-counter (OTC) pharmaceuticals and other healthcare products that are marketed with a focus on the pharmacy distribution channel. These products are mostly based on natural active pharmaceutical ingredients with documented efficacy and few known side effects.

The Company’s core brands cover chronic indications, including rheumatic pain, nerve pain and other age-related ailments. In Germany, PharmaSGP is the market leader for systemic chemical-free pain remedies with its brand families RubaXX^® for rheumatic pain and Restaxil^® for neuralgic pain. Furthermore, PharmaSGP also offers leading products against sexual weakness and vertigo symptoms. Since introducing the first product from the current product portfolio in 2012, PharmaSGP has successfully established its business model in other European countries, including Austria, Italy, Belgium, Spain and France. In September 2021, the product portfolio was expanded by the brands Baldriparan^®, Formigran^®, Spalt^® and Kamol^®, thus also strengthening or developing the indications pain and sleep disorder. The sales territory was expanded to include Switzerland and Eastern Europe. In 2021, PharmaSGP generated revenues of € 65.3 million at an adjusted EBITDA margin of 29.7%.

In order to further expand its competitive position, PharmaSGP plans to increase the number of indications covered by PharmaSGP’s product offering, increase PharmaSGP’s European footprint, and accelerate its growth strategy especially by capitalizing on selected M&A opportunities.

Gerresheimer executes on its growth strategy in Emerging Markets boosting capacities in India

Duesseldorf/Kosamba, May 16, 2022. Gerresheimer has significantly ramped up its glass and plastic production capacities in India to satisfy its global pharma customer needs. A new modern plant to produce high quality plastic containers and closures was built at the Kosamba site, and glass production received a new state-of-the-art and sustainable furnace technology. This is in line with the company’s formula G growth strategy.

By adding capacities in India, Gerresheimer executes on its growth strategy in Emerging Markets addressing the global mega trend for increasing health care access in these markets and the rising demand for vaccination. Being a leading partner for global pharma and healthcare customers, Gerresheimer already operates in India. The new production capabilities combine the company’s know how and network in glass and plastic, offering solutions alongside the broad Gerresheimer portfolio.

“With our outstanding portfolio in pharma and healthcare solutions, Gerresheimer is contributing to the health and well-being of millions of patients worldwide. India is one of the strongest growing country within the Emerging Markets and a core market of large global pharma companies”, CEO Dietmar Siemssen said. “Our new facilities in India are another important step to serve global pharma customers locally as a one stop shop – with the highest quality and availability.”

Gerresheimer follows a clear roadmap for further global capacity increases alongside its holistic capital allocation process. The capacity increase in India is part of Gerresheimer’s investment program to sharpen the company’s growth and return profile. Over the previous two years, the company invested a double digit million Euro amount into new furnaces in Kosamba with the latest glass melting technology.

The new state of the art furnace is equipped with newest production machines also having most sensitive inspection equipment following the Gerresheimer molded glass production standards. With this technology, the company will substantially enhance its product quality. New lines for glass injection vials as well as solid plastic dosages, closures and security systems have also been ramped up.

Further enhancing Gerresheimer’s local production and sales footprint in Emerging Markets is part of the company’s regional expansion plans. With that, Gerresheimer is well positioned for being global partner for pharma solutions and platforms.

Contact Press
Ueli Utzinger
Group Senior Director Marketing & Communication
T +41 79 400 86 40
ueli.utzinger@gerresheimer.com

Contact Investor Relations
Carolin Nadilo
Corporate Senior Director Investor Relations
T +49 211 6181-220
carolin.nadilo@gerresheimer.com

About Gerresheimer

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 10,000 employees and generated annual revenues in 2021 of around EUR 1.5b. With its products and solutions, Gerresheimer plays an essential role in people’s health and well-being.

• Sales: EUR 2.9 million (+6 % yoy); EMEA (+19 % yoy) and North America (+5 % yoy) as main growth drivers
• EBITDA: EUR -0.5 million (Q1/2021: EUR -0.2 million) impacted by planned build-up of sales infrastructure and conduction of human clinical study
• Silver: First surgeries performed as part of human clinical study for innovative silver antibacterial coating technology

aap Implantate AG (“aap” or the “Company”) started the financial year 2022 in a challenging macroeconomic environment with solid sales growth and EBITDA in line with expectations. In this context, aap increased sales by 6 % compared to the same period of the previous year to EUR 2.9 million (Q1/2021: EUR 2.7 million). In terms of earnings, the Company recorded EBITDA of EUR -0.5 million (Q1/2021: EUR -0.2 million), which mainly reflects the planned expansion of the sales infrastructure in Germany and the U.S. and the conduction of the human clinical study for aap’s innovative antibacterial silver coating technology.

Q1/2022 – Key financial figures

Sales

Overall, the picture is ambivalent when looking at the individual regions: the pleasingly significant growth in the EMEA region (= Europe, Middle East, Africa; +19 %) is mainly based on a revival of business with existing customers in Southeastern Europe and the Middle East. In contrast, the recovery to pre-COVID-19 levels in the individual markets of importance to the Company, Spain and Germany, is taking notably longer than expected and planned, which is reflected above all in a continued lower case volume than before the onset of the COVID-19 pandemic.

In North America, aap remains on a growth track and was able to increase sales (+5 %). After a very slow start in January and the first half of February due to COVID-19 effects, March saw the highest ever number of surgeries performed in a single month.

In Latin America (-26 %) and Asia-Pacific (-34 %), the ongoing impact of the COVID-19 pandemic is clearly reflected. Rising infection rates and zero COVID19 guidelines implemented in some regions impacted business performance in the first months of the fiscal year, in some cases severely. In addition, new regulatory and procurement guidelines that came into force at short notice, particularly in China, are making further expansion of the business more difficult.

EBITDA

• Sales level realized in the first quarter below the Company’s planning mainly due to the aforementioned effects from the COVID-19 pandemic and the war in Ukraine,
• Stable high gross margin (in %) with increase in gross margin^[1] in absolute figures (approx. +EUR 100 thousand) in connection with realized sales growth in Q1/2022,
• Planned increase in personnel expenses mainly due to the expansion of the sales infrastructure in Germany and the USA to implement the planned sales growth, as well as in the areas of quality management, regulatory and clinical affairs to ensure certification in accordance with the new EU Medical Device Regulation (MDR 2017/745/EU) within the transitional period until 2024 as planned
• Stable cost level (excluding non-recurring effects) in other costs in the operating trauma business incl. central administration functions,
• Cost increase from conducting the human clinical study of aap’s innovative silver coating technology with the first surgeries performed and the inclusion of further clinics participating in the study in the first quarter of 2022,
• Lower non-recurring effects that had an earnings-enhancing impact on EBITDA in the first quarter of 2021 (mainly from the recognition of income from COVID-19 support programs).

Excluding the non-recurring effects, recurring EBITDA decreased to EUR -0.4 million in the first quarter of 2022 (Q1/2021: EUR -0.2 million).

Silver coating technology

With regard to aap’s innovative silver coating technology, the first surgeries in the human clinical study for its innovative antibacterial silver coating technology were performed in the first quarter of 2022. The surgeries took place at the University Hospital Regensburg and went according to plan. In addition, the Company was able to include further clinics in the study in the first quarter, so that further patient recruitment can be expected in the coming months. aap had initiated the clinical human study in December last year, which is an essential step towards the planned market approval (CE) of the innovative technology.

Outlook

Despite the currently observable dynamic pressure on global supply chains, the uncertainty regarding the COVID-19 pandemic as previously described, the general inflationary environment and taking into account the first quarter results, the Management Board continues for the time being to adhere to the communicated forecast values for sales and EBITDA for the financial year 2022. Even under the current market adversities, the Company is recording a growing number of new potential distribution channels and aap’s long-standing distribution partners are confident that they will return to pre-pandemic levels in the foreseeable future. In this context, aap’s distribution partners and the Company anticipate a renewed increase in case numbers in the trauma segment due to observable declines in COVID-19 infection figures, a resurgence in global mobility as a result of increased return to work, increased sports and leisure activities, and a resurgence in numbers in the tourism industry.

^[1] Gross margin = sales revenue +/- change in inventories of finished goods and work in progress – cost of materials / cost of purchased services
 

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aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German Stock Exchanges –

About aap Implantate AG
aap Implantate AG is a globally active medical technology company based in Berlin, Germany. The company develops, manufactures and markets products for traumatology. In addition to the innovative LOQTEQ® anatomical plate system, the IP-protected portfolio includes a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical problems in traumatology that have not yet been adequately solved. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and group clinics, while at international level it primarily uses a broad network of distributors in around 25 countries. In the USA, the company relies on a hybrid sales strategy through its subsidiary aap Implants Inc. This involves sales both via distribution agents and as part of partnerships with global orthopedic companies. The aap Implantate AG share is listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at https://www.aap.de/

The figures presented in this press release may be subject to technical rounding differences which do not affect the overall presentation.

Forward-looking statements
This release may contain forward-looking statements based on current expectations, beliefs and projections of the Management Board and currently available information. The forward-looking statements are not guarantees of future performance or results. 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 aap’s public reports. Forward-looking statements therefore speak only as of the date they are made. We assume no obligation to update the forward-looking statements made in this release or to conform them to future events or developments.

APONTIS PHARMA holds Annual General Meeting 2022 – shareholders approve all agenda items with large majorities

Monheim am Rhein, 12 May 2022. APONTIS PHARMA AG (Ticker APPH / ISIN DE000A3CMGM5), a leading pharmaceutical company specializing in Single Pills in the German market, today successfully held its Annual General Meeting in virtual form.

The Annual General Meeting expressed its confidence in the members of the Executive Board and the Supervisory Board of APONTIS PHARMA AG for the 2021 financial year and approved all items on the agenda with large majorities. In his speech, CEO Karlheinz Gast detailed the developments in the past financial year and provided an outlook for 2022.

“We have grown profitably and significantly faster than the overall market and have consistently expanded our Single Pill portfolio. The START study demonstrates the medical and economic benefits of our Single Pills and at the same time our development pipeline offers a lot of potential for future growth. We would like to thank our shareholders for the trust they have placed in us,” said Karlheinz Gast, CEO of APONTIS PHARMA AG.

With the end of the Annual General Meeting 2022, the term of office of all previous members of the Company’s Supervisory Board also expired. The new supervisory body elected by the shareholders is composed as follows: Dr. Edin Hadzic, Dr. Matthias Wiedenfels, Christian Bettinger, Olaf Elbracht and Dr. Anna Lisa Picciolo-Lehrke. In the constituent meeting of the new Supervisory Board following the Annual General Meeting, Dr. Matthias Wiedenfels was elected Chairman and Olaf Elbracht Deputy Chairman.

With Dr. Matthias Wiedenfels, a proven pharmaceutical expert is taking over as Chairman of the Supervisory Board. As former CEO of STADA Arzneimittel AG and member of the Supervisory Board of BioMedion AG, Dr. Wiedenfels has extensive experience and a wide-ranging industry network. The same applies to Olaf Elbracht, who has already held various responsible positions, including Vice President Global Business Services Finance at UCB Pharma S.A. and Chief Financial Officer at Schwarz Pharma AG. Dr. Anna Lisa Picciolo-Lehrke joins the Supervisory Board as a new member. She has already played a key role in earlier years in the orientation of today’s APONTIS PHARMA towards single pills and has been Head of Global Business Development Neurology at UCB Pharma GmbH since 2017.

For the current financial year 2022, Ebner Stolz GmbH und Co. KG Wirtschaftsprüfungsgesellschaft Steuerberatungsgesellschaft, Bonn, was appointed as auditor of the financial statements and consolidated financial statements.

With 82.01% of the capital stock represented in the voting, all of the management’s proposed resolutions were adopted by large majorities.

The detailed voting results will be published on the Company’s website at ir.apontis-pharma.de.

About APONTIS PHARMA:

APONTIS PHARMA AG is a leading pharmaceutical company specializing in Single Pills in Germany. Single Pills combine two to three generic active ingredients in a single dosage form. APONTIS PHARMA develops, promotes and sells a broad portfolio of Single Pills and other pharmaceutical products, with a special focus on cardiovascular diseases. Since 2013, APONTIS successfully launched several Single Pill products alone for cardiovascular indications such as hypertension, hyperlipidemia and secondary prevention. With its headquarters in Monheim am Rhein, APONTIS PHARMA is located in one of Europe’s leading pharmaceutical and chemical region. From here, the company maintains a broad network with research-based pharmaceutical companies and a customer target group of approx. 23,000 physicians in Germany. For additional information about APONTIS PHARMA, please visit www.apontis-pharma.de.

APONTIS PHARMA AG

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

APONTIS PHARMA Presse Contact

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