– PAION will receive a milestone payment of EUR 15 million from Cosmo and tiered royalties on net sales ranging from 20% to 25%

– Acacia, who will commercialize BYFAVO^TM (remimazolam) in the U.S., is planning to launch in the second half of 2020

Aachen (Germany), 02 July 2020 – The specialty pharma company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the U.S. Food and Drug Administration (FDA) has approved BYFAVO^TM (remimazolam) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. BYFAVO^TM is a very rapid onset/offset intravenous benzodiazepine sedative for use during invasive medical procedures lasting 30 minutes or less, such as colonoscopy and bronchoscopy. Approximately 25 million such procedures take place annually in the U.S., of which ~90% use moderate sedation. Remimazolam is also in development for general anesthesia.

PAION has developed BYFAVO^TM including the conduct of three Phase III clinical studies and granted Cosmo Pharmaceuticals NV (Cosmo) exclusive rights to develop and commercialize BYFAVO^TM for the U.S. market in 2016. In January 2020, Acacia Pharma sub-licensed the commercial rights to BYFAVO in the U.S. from Cosmo.

Under the terms of the agreement with Cosmo, PAION will receive a milestone payment of EUR 15 million from Cosmo and is entitled to tiered royalties on net sales in the U.S. ranging from 20% to 25%, which may be adjusted under certain conditions but cannot fall below 15% of net sales.

End of inside information

– PAION will receive a milestone payment of EUR 15 million from Cosmo and tiered royalties on net sales ranging from 20% to 25%

– Acacia, who will commercialize BYFAVOTM (remimazolam) in the U.S., is planning to launch in the second half of 2020

– Conference call hosted by Acacia scheduled for 9:00 am ET, Monday 6 July 2020

Aachen (Germany), 02 July 2020 – The specialty pharma company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the U.S. Food and Drug Administration (FDA) has approved BYFAVO^TM (remimazolam) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. BYFAVO^TM is a very rapid onset/offset intravenous benzodiazepine sedative for use during invasive medical procedures lasting 30 minutes or less, such as colonoscopy and bronchoscopy. Approximately 25 million such procedures take place annually in the U.S., of which ~90% use moderate sedation. Remimazolam is also in development for general anesthesia.

PAION has developed BYFAVO^TM including the conduct of three Phase III clinical studies and granted Cosmo Pharmaceuticals NV (Cosmo) exclusive rights to develop and commercialize BYFAVO^TM for the U.S. market in 2016. In January 2020, Acacia Pharma sub-licensed the commercial rights to BYFAVO in the U.S. from Cosmo.

Under the terms of the agreement with Cosmo, PAION will receive a milestone payment of EUR 15 million from Cosmo and is entitled to tiered royalties on net sales in the U.S. ranging from 20% to 25%, which may be adjusted under certain conditions but cannot fall below 15% of net sales.

###

Dr. Jim Phillips, CEO of PAION AG, commented: The U.S. marketing approval of BYFAVO^TM marks the most significant milestone in PAION’s history, and I congratulate everyone who has played a role in this important achievement. The U.S. is the world’s largest pharmaceutical market, and we are excited to see the product PAION successfully developed being made available to doctors there. We wish Acacia a highly successful market launch in this important market, and we will be supporting their commercialisation efforts. We also look forward to remimazolam being rolled out in other countries around the globe as we and our partners work to gain additional marketing approvals.”

“We are very pleased to announce today the approval of BYFAVO^TM in the U.S. for procedural sedation in adult patients,” commented Mike Bolinder, Acacia Pharma’s CEO. “This marks the second FDA approval of an Acacia Pharma product since the start of 2020 and another major milestone in our evolution into an integrated hospital pharmaceutical company with strong development and commercialization capabilities. The addition of BYFAVO^TM to our product portfolio strengthens our offering to anesthesiologists and enables us to further leverage our commercial infrastructure. I would like to thank our partners at PAION and Cosmo as well as the Acacia Pharma team and our stakeholders who have enabled us to bring this new and innovative therapeutic to market to address the needs of millions of patients each year undergoing procedures that require sedation.”

Gerard A. Silvestri, MD, MS, Professor of Medicine at the Medical University of South Carolina, Charleston, SC, and past-president of the American College of Chest Physicians, commented: “The approval of remimazolam (BYFAVO^TM) is very exciting for proceduralists as the field has not seen new sedation medications added to our armamentarium in decades. The drug performed very well in clinical trials, with an excellent sedation effect enabling 80-90% of procedures to be completed successfully. The cardio-respiratory safety profile looked very encouraging and there was a rapid return of patients to consciousness enabling them to be discharged in a timely manner.”

“It is gratifying to see how successfully our new strategy is unfolding. We entered into new partnerships with RedHill Biopharma and Acacia before their own main products were approved by taking substantial equity stakes in these companies and integrating our products Aemcolo^(R) and BYFAVO^TM into each so that they could potentially have a more stable and efficient marketing organization. The approval of BYFAVO^TM follows the approval of RedHill’s Talicia^(R) and Acacia’s BARHEMSYS^(R) and is the third FDA approval in nine months for products in companies in which we hold an equity stake. We are now looking forward to Acacia Pharma’s transforming BYFAVO into a resounding success,” said Alessandro Della Chà, CEO of Cosmo Pharmaceuticals.

“BYFAVO^TM is an important addition to the limited selection of drugs available for procedural sedation,” said Acacia Pharma’s Chief Medical Officer, Dr. Gabriel Fox. “BYFAVO^TM demonstrated clear patient benefits in its extensive clinical trial program, offering very rapid onset and offset of action coupled with an incidence of cardio-respiratory and other adverse reactions similar to that seen in patients in the placebo group. We are grateful to all the clinical investigators and patients who made this approval possible through their participation in the development program.”

The safety of BYFAVO^TM was evaluated in three pivotal studies in 669 patients undergoing colonoscopy (two studies) or bronchoscopy (one study), of whom 630 received BYFAVO^TM. In these studies, the most common adverse reactions (incidence greater than 10%) following BYFAVO^TM administration were hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension. The labeling for BYFAVO^TM includes a Boxed Warning regarding appropriate training of personnel and equipment that must be available when administering BYFAVO^TM, during sedation and during the recovery period of the procedure. The Boxed Warning also addresses risks from concomitant use of BYFAVO^TM with opioid analgesics and other sedative hypnotics.

Acacia Pharma’s first product, BARHEMSYS^(R) (amisulpride injection), was approved by the FDA on 26 February 2020 for the treatment and prevention of postoperative nausea and vomiting (PONV) in adult patients and the company intends to launch both BARHEMSYS^(R) and BYFAVO^TM in the U.S. during the second half of 2020.

Conference Call hosted by Acacia Pharma

The Acacia Pharma management team will host a conference call Monday, 6 July 2020, at 9:00 ET.

For further information, please see:

– Press release Acacia Pharma (02 July 2020)

About remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and is not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary. In clinical studies, remimazolam demonstrated efficacy and safety in around 2,900 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.

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

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

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

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

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

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

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

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

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

In 2014 BRAIN AG made a strategic investment into WeissBioTech to gain access to the growing and profitable enzyme market. Since then, BRAIN AG and WeissBioTech have worked closely together to discover, develop and sell innovative enzyme products and solutions for customers worldwide.

In 2018, BRAIN AG made another key strategic move through its acquisition of Biocatalysts Ltd. in Cardiff, UK, an enzyme company with strong fermentation technology and enzyme R&D, serving specialty niche markets. Together with BRAIN’s extensive enzyme technology skills, the WeissBioTech and Biocatalysts capabilities will form a solid platform for strong growth in the specialty enzymes business.

Adriaan Moelker, CEO BRAIN AG, states: “We are continuously working to build and optimize the group structure as announced during our capital increase in June, 2020. The full acquisition and integration of WeissBioTech GmbH gives us important flexibility to optimize our production network and capture synergies within the group. I would particularly like to thank founder Hans de Bie for his significant contribution to the development of the company ( and Lukas Linnig at BRAIN who made this agreement come to fruition. Ultimately, all our stakeholders will benefit from this transaction.”

About BRAIN

B.R.A.I.N. Biotechnology Research and Information Network AG (BRAIN AG; ISIN DE0005203947 / WKN 520394) is one of Europe’s leading technology companies in the field of industrial biotechnology, the core discipline of Bioeconomy. As such, BRAIN identifies previously untapped, efficient enzymes, microbial producer organisms or natural substances from complex biological systems that can be put to industrial use. The innovative solutions and products developed by help of this “Toolbox of Nature” are successfully applied in the chemistry, the cosmetics and the food industries. BRAIN’s business model is based on two pillars. The BioScience segment comprises mainly of the research and development business with industrial partners (the “Tailor-Made Solutions” cooperation business), and the company’s own research and development. The BioIndustrial segment consists mainly of the industrially scalable products business. Further information is available at www.brain-biotech.com.

We are pleased to announce that our project company, inflamed pharma GmbH has received 70% of necessary funds from the Thüringer Aufbaubank. The grant is intended to cover the feasibility studies of our active ingredient, “valersan19” which treats inflammation and microcirculation disorders caused by COVID-19.

About inflamed pharma GmbH

inflamed pharma GmbH produces, researches and develops chemical and active pharmaceutical ingredients and is a pharmaceutical ingredient manufacturer of products applied in innovative therapies for human and veterinary medicine. One of these substances is an active pharmaceutical ingredient based on the active pharmaceutical ingredient substance procaine.
Procaine is a globally used active pharmaceutical ingredient substance in the category of local anesthetics, it is well-tested, low in side-effects and applied in various indications, for instance, in neural therapy. The application in relation with pain and inflammation such as arthritis and arthrosis is less established but crucial. Through the patented manufacturing process, the formerly solely parental available pharmaceutical ingredient is now useable for oral and dermal application and it is possible to realize synergistic effects in terms of impact. This is possible through an enhanced bioavailability. This technology of clustering, where the active pharmaceutical ingredient is integrated in a protecting shell, allows the transfer to other active pharmaceutical ingredients. This active pharmaceutical ingredient is currently used as extemporaneous mixture for manufacturing of pharmaceuticals of the inhouse production. Inflamed pharma GmbH is a GMP-certified manufacturer of active pharmaceutical ingredients and aims to conduct a clinical study in cooperation with University Hospital Jena, leading to the application for approval.

About Xlife Sciences AG

Xlife Sciences AG is a Swiss company with focus on investing in promising technologies in the life science industry. Xlife Sciences AG is building the bridge from research and development to healthcare markets by supporting researchers and entrepreneurs in positioning, structuring, developing and implementing their concepts. Together with industrial partners or universities, Xlife Sciences AG leads projects through the proof-of-concept phase after an invention disclosure or start-up. Subsequently, the firm focuses on out-licensing or selling the company, often with a combination of a strategic partnership. Xlife Sciences AG offers its investors direct access to the further development of innovative and future-oriented technologies at a very early stage.
For more information, please visit: www.xlifesciences.ch

Abivax treats first patient in Phase 2b/3 ABX464 Covid-19 clinical trial

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• First patient treated in “miR-AGE” trial at University Hospital Center in Nice (CHU Nice)
• 50 study sites and 1,034 high-risk patients to participate in the European and
• Latin American placebo-controlled trial
• ABX464 works via unique triple action: antiviral, anti-inflammatory and tissue repair
• Easy, once daily oral administration allows inclusion of hospitalized as well as non-hospitalized COVID-19 patients
• Results from this study expected by year-end

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PARIS, France, July 02, 2020 – 07:30 a.m. (CEST) – Abivax SA (Euronext Paris: FR0012333284 – ABVX), a late stage clinical biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announces today that the first patient has been treated in its Phase 2b/3 study of ABX464 in COVID-19 patients at the University Hospital Center in Nice, France (CHU Nice).

The randomized, double-blind, placebo-controlled miR-AGE study investigates the effect of early treatment (at point of diagnosis) in 1,034 COVID-19 elderly or high-risk patients. The main goal of the trial is to measure the potential of ABX464 to limit viral replication as well as the severe inflammation that leads to acute respiratory distress syndrome (ARDS). Abivax has already received clearance for the study from the regulatory authorities in France and Germany as well as in the UK, Italy and Brazil and expects authorization to follow in Spain and additional Latin American countries with high infection rates, including Mexico, Chile and Peru in due course.

Prof. Hartmut Ehrlich, M.D., CEO of Abivax, said: “We are pleased that the first patient in our miR-AGE trial has been treated and that recruitment and treatment at further sites in Europe and Latin America can now proceed swiftly. After the approval of the regulators in Brazil, additional regulatory approvals in Latin American countries, where the epidemic has still not reached its peak, are expected to follow soon. We expect first top-line results from miR-AGE by the end of the year. Enrollment in our other clinical trials is now back on track with more than half (122/232) of the patients randomized in the ulcerative colitis Phase 2b trial and with recruitment in the Phase 2a trial in rheumatoid arthritis and the US Phase 1/2 trial in hepatocellular carcinoma progressing as well. With non-dilutive funding provided by Bpifrance and Société Générale, Abivax’s projects are fully financed until early 2021 and discussions for further, preferably non-dilutive financial options are ongoing.”

“The treatment of the first patient in the miR-AGE trial is an important milestone for Abivax,” added Philippe Pouletty, M.D., Chairman of the Board of Abivax and CEO of Truffle Capital. “While further study centers in Europe are being initiated, we also continue to expand the trial in additional Latin American countries. The already available regulatory and national ethics committee clearance in Brazil make a recruitment start in July realistic, as we are only missing the local ethics approvals. Furthermore, the ongoing preparation of filing in Mexico, Chile and Peru are very important, as the pandemic is still very active in these countries. While we are confident that ABX464 may have a positive impact by reducing the severity of COVID-19 sequelae, we remain prudent on expectations for the miR-AGE trial given the complexities surrounding treatment of COVID-19 disease. Progressing ABX464 development in chronic inflammatory diseases remains Abivax’s corporate priority.”

Eric Cua, M.D., Infectiologist at the University Hospital Center (CHU) of Nice, said: “As the principal investigator at the CHU in Nice, I am glad that the first patient has been treated and I am very much looking forward to evaluating whether early treatment with ABX464 will have a positive effect in COVID-19 patients. ABX464’s unique triple mode of action could potentially limit the replication of SARS-CoV-2 virus, prevent and treat the cytokine storm or hyper-inflammation – and the ensuing acute respiratory failure syndrome – as well as limit long-term lung injury through tissue repair. Due to ABX464’s easy, once-daily oral administration, we can include hospitalized as well as non-hospitalized COVID-19 patients in this trial. We hope that the findings in this placebo controlled and randomized trial bring us one step closer to a potent treatment for this disease in order to protect especially high-risk patients and avoid tense situations in hospitals and intensive care units in the future.”

ABX464 has already demonstrated impressive efficacy in a Phase 2a trial in another severe inflammatory disease, ulcerative colitis (UC). In this trial, specifically, potent anti-inflammatory effects and tissue healing were observed. The results in UC patients together with the unique molecular mechanism of action of ABX464 support the rationale to use the drug candidate to treat the cytokine storm and hyper-inflammation syndrome observed in COVID-19 patients. Hyper-inflammation in the lung is the primary cause of the respiratory distress and potential death in COVID-19 patients.

ABX464’s molecular action has been shown to upregulate a micro-RNA, miR-124, which is a “physiological brake” on inflammation. It works by down-regulating the multiple chemo- and cytokines involved in the COVID-19 cytokine storm, including TNF alpha, IL-1 beta, G-CSF, IL-6, MCP-1 and IL-17. In addition, unlike other potent anti-inflammatory agents that specifically target single cytokines, ABX464 has not been associated with increased vulnerability to opportunistic infections or a damping down of the immune system.

Furthermore, in previous clinical testing ABX464 has been shown to have antiviral effects against HIV and it is the first therapeutic candidate ever in development that reduced HIV reservoirs in patients. More recently, ABX464 demonstrated a marked antiviral effect, inhibiting SARS-CoV-2 (COVID-19) replication in reconstituted human respiratory epithelium model.

Financing for this Phase 2b/3 trial, as well as manufacturing scale-up, additional clinical and other development costs is provided by the French investment bank Bpifrance, with 36 million EUR in non-dilutive funding. In addition, Abivax recently received 5 million EUR in non-dilutive financing from Société Générale in the form of a loan guaranteed by the French state. Abivax’s operations and ongoing clinical study programs are fully financed until early 2021.

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About Abivax

Abivax, a clinical stage biotechnology company, is mobilizing the body’s natural immune machinery to treat patients with autoimmune diseases, viral infections, and cancer. Abivax is listed on Euronext compartment B (ISIN: FR0012333284 – Mnémo: ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, ABX464 to treat severe inflammatory diseases, and ABX196 to treat hepatocellular carcinoma.
More information on the company is available at www.abivax.com. Follow us on Twitter @ABIVAX_.

Contacts

DISCLAIMER

This press release contains forward-looking statements, forecasts and estimates (including patient recruitment) with respect to certain of the Company’s programs. Although the Company believes that its forward-looking statements, forecasts and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors that have been deemed reasonable, such forward-looking statements, forecasts and estimates are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in such forward-looking statements, forecasts and estimates. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its registration document (Document de Référence). Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law.
This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction, in particular in France. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgement. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

This is intended to ensure that the largest amount of shares possible remain tradable and in free float.

About Xlife Sciences AG

Xlife Sciences AG (m:access: XLS) is a Swiss company with focus on investing in promising technologies in the life science industry. Xlife Sciences AG is building the bridge from research and development to healthcare markets. Together with industrial partners or universities, Xlife Sciences AG leads projects through the proof-of-concept phase after an invention disclosure or start-up. Subsequently, the firm focuses on out-licensing or selling the company, often with a combination of a strategic partnership. Xlife Sciences AG offers its investors direct access to the further development of innovative and future-oriented technologies at a very early stage.
For more information, please visit: www.xlifesciences.ch

As of today, the shares of Xlife Sciences AG are traded in cooperation with the designated sponsor M.M.Warburg & CO on the electronic trading system XETRA of the Frankfurt Stock Exchange.
XETRA is by far the most important electronic trading venue in Germany with approximately 90% of all equity transactions in Germany occurring there. The ability to trade Xlife Sciences AG shares on XETRA will significantly increase trading volumes. Higher liquidity will result in tighter bid/ask spreads and orders will be able to be executed faster. The overall result will be more consistent and stable pricing.
Thus, Xlife Sciences AG continues focusing on the needs of its investors and further cultivates relationships with institutional investors

About Xlife Sciences AG

Xlife Sciences AG (m:access: XLS) is a Swiss company with focus on investing in promising technologies in the life science industry. Xlife Sciences AG is building the bridge from research and development to healthcare markets. Together with industrial partners or universities, Xlife Sciences AG leads projects through the proof-of-concept phase after an invention disclosure or start-up. Subsequently, the firm focuses on out-licensing or selling the company, often with a combination of a strategic partnership. Xlife Sciences AG offers its investors direct access to the further development of innovative and future-oriented technologies at a very early stage.
For more information, please visit: www.xlifesciences.ch

2019 – Major Results and Progress

– Sales by region: Double-digit growth rates in USA (+14%) and in international markets (+10%); continuation of stable growth trend in Germany (+2%)

– USA: Continued dynamic development; almost doubling of number of weekly operations performed since end of September 2019 compared with previous year and conclusion of contracts with two national purchasing groups; far advanced negotiations on conclusion of development and supply contract with leading US medical technology company

– Earnings: Strongly improved EBITDA (+20%) due to higher total operating performance, higher gross margin, increase in other operating income and reduced other operating expenses; EBITDA in FY/2019 influenced by substantial one-time effects; Recurring EBITDA also significantly improved with EUR -3.7 million (FY/2018: EUR -5.0 million)

– Costs: Continued consistent implementation of cost reduction and efficiency improvement program with change of stock exchange listing and discontinuation of parts of standard trauma portfolio in FY/2019; in FY/2020 already extensive staff reduction (approx. 25% of personnel) with aim of annual cost savings of more than EUR 1.3 million from 2021; further cost reductions ongoing

– Cash flow and balance sheet: Cash holdings of EUR 3.2 million^[1] and continued high equity ratio
of 72%

– LOQTEQ(R): FDA approval for polyaxial LOQTEQ(R) VA foot and calcaneus systems; focus in FY/2019 on quality management and four audits performed; continued focus on conversion of documentation to regulatory requirements of MDR and sterile-packaged implants

– Silver coating technology: With approval for clinical human study by BfArM in 2019 and release by ethics commissions in 2020, all regulatory requirements for start of study in Germany fulfilled; further funding of up to approximately EUR 2.7 million for conduction of human clinical study by BMBF; due to corona pandemic, no concrete start date for study can currently be determined

– Resorbable magnesium implant technology: regulatory clearance path in USA largely coordinated with FDA; very promising initial results in pilot animal study with Colorado State University to obtain essential preclinical data; talks with technology-savvy investors intensified for joint further development of the technology

For a detailed evaluation of the Management Agenda 2019 aap refers to the consolidated annual financial report 2019, published today.
 

2019 – Financials

Sales

In view of developments in individual markets, aap was able to continue the stable growth trend in the German market in 2019, increasing sales by 2% to EUR 2.8 million (FY/2018: EUR 2.8 million). Business in international markets also developed positively. Here, the company achieved growth of 10% to EUR 6.9 million (FY/2018: EUR 6.2 million), which is primarily due to the expansion of existing sales relationships. Following a stabilizing phase in the first nine months of 2019, dynamic development has been observed in the USA since the end of September. The number of weekly operations was almost doubled compared to the same period of the previous year, which is also reflected in a sales increase of around 56% in the fourth quarter of 2019. As a result, aap recorded sales growth of 14% to EUR 2.0 million in the financial year 2019 (FY/2018: EUR 1.8 million). In addition, in the fourth quarter of 2019 the Company concluded contracts with two national purchasing groups that give aap access to a US-wide network of hospitals and surgical operation centres. Talks with other purchasing groups are also currently under way. In addition, the Company is in far advanced negotiations on concluding a development and supply contract with a world-leading U.S. medical technology company.
 

EBITDA

In the financial year 2019 aap recorded a strongly improved EBITDA of EUR -5.1 million (FY/2018: EUR -6.4 million). The EBITDA was significantly influenced by the following developments:

– Higher total operating performance in particular due to sales growth with only very small increase in inventories and lower level of capitalized internal and development work

– Gross margin increases from 78% to 80% due to improved product-, customer- and price-mix and higher share of high-margin US sales in total sales

– Increase in other operating income, in particular due to BMBF grants for silver coating technology and cost reimbursements due to termination of legal disputes

– Decrease in other operating expenses

Outlook for 2020

The corona pandemic leads to a significant impairment of business operations at aap, which is reflected in a corresponding decline in sales and earnings in the first two quarters of 2020. In addition, restructuring measures such as the staff reduction announced in March 2020 will lead to one-time expenses in the current financial year that will additionally burden earnings. In addition, the decision taken in the annual financial statements to no longer capitalize the costs of the two development projects antibacterial silver coating and resorbable magnesium implants will have a full impact on EBIDTA from the 2020 financial year. Against this backdrop, the Management Board expects a significantly lower level of sales and earnings for the financial year 2020. On the basis of the data currently available, sales are expected to be between EUR 8 million and EUR 10 million and EBITDA between EUR -6.7 million and EUR -5.5 million. It should be noted, however, that the available forecast data is characterized by a high degree of uncertainty. This is based in particular on the corona pandemic, the further course of which is very difficult to assess at the present time. For example, in the second half of 2020 a second wave, feared by some virologists and experts, could occur, which in the worst case could lead to a renewed lockdown with corresponding negative effects for the economy.
 

Looking at the individual markets, it can be seen that in the first two quarters, in addition to Germany, international business in particular was affected by the effects of the corona pandemic, so that a corresponding significant year-on-year decline in sales was recorded in each case. On this basis aap intends to stabilize sales development in both markets by the end of the year if the pandemic is positive so that from 2021 sales can once again show a positive dynamic. In the USA, on the other hand, the Company continues on a strong growth course despite the corona pandemic and in the year to date has been able to increase sales significantly with a double digit growth rate over the previous year. After the first two contracts with national purchasing groups were concluded in 2019, further contracts are to follow in the current fiscal year, thus creating the basis for further growth. Overall, aap is striving despite COVID-19 for an increase in sales of at least 30 % in the USA in financial year 2020 compared to the previous year.
 

On the cost side, aap will continue to consistently implement the cost reduction and efficiency improvement program already launched in financial year 2019. The aim is to streamline the Company’s cost structure sustainably and thereby increase efficiency and flexibility. In this context, the number of employees has already been reduced in the current financial year by around 25% compared with the level at the end of February 2020 (monthly closing date before the measure was announced on March 16), which should lead to annual cost savings of more than EUR 1.3 million from 2021. aap plans further cost reductions in the area of administration, among other things, and is in negotiations with its IT service provider and landlord in this connection. The manufacturing costs shall be reduced by at least 20%.
 

Overall, aap is currently undergoing a comprehensive restructuring and refinancing process to secure the Company’s continued existence and future viability. Against this background the Management Board is currently working intensively on the implementation of various financing and cost-saving options. For further details we refer to the insider information published on June 29, 2020 in accordance with Article 17 of the MAR.

^1] In the consolidated balance sheet of 12/31/2019 EUR 2.9 million is stated as cash and cash equivalents, while cash with banks totalling EUR 0.3 million is shown under current and non-current other financial assets as it was pledged to secure financial liabilities respectively cash payments were made to secure bank guarantees granted to third parties.

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aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German stock markets –

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 trauma. The IP-protected portfolio includes besides the innovative anatomical plating system LOQTEQ(R) a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as the antibacterial silver coating technology and magnesium-based implants. These technologies address critical and unmet needs in trauma. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups, and hospital groups, while at international level it primarily uses a broad network of distributors in around 25 countries. In the US the Company pursues a hybrid distribution strategy with its subsidiary aap Implants Inc. Distribution is carried out both through distribution agents and partnerships with global orthopedic companies. aap Implantate AG’s stock is listed in the General Standard segment of Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit our website at www.aap.de.

Forward-looking statement
This release may contain forward-looking statements based on current experience, estimates and projections of the management board and currently available information. They are not guarantees of future performance. 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. Many factors could cause the actual results, performance or achievements of aap to be materially different from those that may be expressed or implied by such statements. These factors include those discussed in aap‘s public reports. Forward-looking statements therefore speak only as of the date they are made. aap does not assume any obligation to update the forward-looking statements contained in this release or to conform them to future events or developments.

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curasan AG: curasan AG postpones annual financial report 2019 to 31 July 2020

Kleinostheim, Germany, 30 June 2020 – The Management Board of curasan AG (shares: ISIN DE000A2YPGM4 / convertible bond: ISIN DE000A2TR497) announces that the publication of the annual financial report 2019, originally planned for 30 June 2020, will be postponed to 31 July 2020. The reason for the delay is that the binding offer submitted by Donau Invest Beteiligungsges. m.b.H., Vienna, which is to be implemented in the insolvency plan, still has to be examined by the auditor with regard to the continuation prognosis.

Contact curasan AG:
Andrea Weidner
Investor Relations &
Corporate Communications
+49 6027 40 900-51
ir@curasan.com

About curasan AG:
curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, curasan, Inc., in Wake Forest, near Raleigh, N.C., USA. curasan’s innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide. curasan AG is a public company listed in the General Standard at the Frankfurt Stock Exchange.