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EQS Newswire / 29/11/2024 / 09:00 UTC+8 (28 November 2024, Hong Kong) – Modern Dental Group Limited (“Modern Dental” or “the Group“, stock code: 03600.HK), a leading global dental prosthetic devices provider, announced its operational data for the nine months ended 30 September 2024.
During the nine months ended 30 September 2024, although the macro-economic environment continues to be challenging, the Group’s multi-dimensional strategies and comprehensive products portfolio, encompassing higher-priced and cost-effective dental treatments, enabled the Group to capitalize on market opportunities by capturing new customers and increase its sales volume, displaying the Group’s ability to outperform its competitors throughout the economic cycle.
Global Revenue For the nine months ended 30 September 2024, the total revenue of the Group increased by approximately 6.7% (approx. HK$2,521.6 million) compared with the nine months ended 30 September 2023 and the total revenue of the Group (ex-MicroDental) increased by 9.0% (approx. HK$2,078.7 million) compared with the nine months ended 30 September 2023.
^ The increase in sales in original currency of the North America market (ex-MicroDental) was approximately 7.9% and the decrease in sales in original currency of MicroDental was approximately 2.8%. # The increase in sales in original currency of the Mainland China market was approximately 6.1% and the decrease in sales in original currency of the Hong Kong market was approximately 19.5%.
The double-digit increase in revenue in Europe clearly represents our outperformance in gaining market share, driven by the digitalization trend in the dental industry. During the period, the Group also experienced growth in North America (ex-Microdental) (+7.9%), Mainland China (+6.1%), Australia (+5.5%) and the Others (+31.5%) markets, reflecting our Group’s competitiveness during a challenging macro-economic environment.
The decrease in sales in MicroDental, our North America domestic labs business, was affected by the weakness in demand of implant dental treatments (a discretionary option for patients) and the softness in the US economy. However, this was offset by the increase in sales of our offshore-made products business supplied by Mainland China and Vietnam, as a result of the enhancement of competitiveness of offshore-made products following the adoption of digitalization practices.
As a result of the increase in sales volume in the Mainland China market following the full implementation of the volume-based procurement policy in the Mainland China market gradually since the second half of 2023, our Mainland China business reported a sales growth of 6.1% for the nine months ended 30 September 2024 compared to the same period of 2023. This also led to aggressive promotions for dental implant treatments by Mainland China dental clinics in Hong Kong (which experienced a notable decrease in patient visits in Hong Kong).
The increase in revenue from Australia was predominately due to the increase in sales volume as a result of the increase in market share driven by the digitalization trend in dental industry.
Sales Volumes (Number of Cases) For the nine months ended 30 September 2024, the total sales volumes of the Group increased by approximately 5.4% to approximately 1,633,000 cases and the total sales volumes of the Group (ex-MicroDental) increased by approximately 6.5% to approximately 1,448,000 cases.
Digital Solution Cases For the nine months ended 30 September 2024, the Group’s digital solution cases that are produced from its Mainland China production facilities increased to approximately 939,000 cases reflecting an increase of 57.6% for the same period in 2023 as a result of our clients’ increased adoption of intra-oral scanners.
Average Selling Price For the nine months ended 30 September 2024, the average selling price of the Group’s dental prosthetic products across its markets was HK$1,442 per case, representing an increase of approximately 0.5%, and the average selling price of the Group’s (ex-MicroDental) dental prosthetic products across its markets was HK$1,321 per case, representing an increase of approximately 1.6% compared with same period in 2023.
The increase in average selling price was mainly due to the increment in price of our products and the change in product mix offset by depreciation of Renminbi and Australia Dollars against Hong Kong Dollars and the decrease in price of certain dental prosthetic teeth products associated with the volume-based procurement for dental implant treatment in the Mainland China.
Looking forward, the global digitalization trend continues to accelerate the consolidation of the dental prosthetics industry, allowing the Group to further increase its market share in the industry and our continued digital transformation is expected to improve our customers’ and patients’ experiences, further allowing the Group to differentiate itself from its competitors and outperform the industry peers.
The Group’s continued sales increase represents a solid execution across each of the Group’s markets operationally and financially, illustrating the Group’s ability to deliver strong financial results in a relatively stable operating environment characterized by consistent order volume growth, competitiveness in the industry, and close relationship with its clients and customers. The Group’s underlying fundamentals continue to be solid and we are well-positioned to capture further opportunities going forward.
About Modern Dental Group
Modern Dental Group Limited (Stock code: 03600.HK) is a leading global dental prosthetics provider, distributor and consultant with a focus on providing custom-made prostheses to customers in the growing prosthetics industry. Our product portfolio is broadly categorized into three product lines: fixed prosthetic devices, such as crowns and bridges; removable prosthetic devices, such as removable dentures; and other devices, such as orthodontic devices, sports guards, clear aligners, and anti-snoring devices.
Modern Dental Group has a global portfolio of respected brands, including Labocast, Permadental and Elysee Dental in Western Europe, YZJ Dental in China, Modern Dental Lab in Hong Kong, MicroDental in the United States, Modern Dental Pacific in Australia and New Zealand, Modern Dental SG in Singapore, Modern Dental TW in Taiwan, and Apex Digital Dental in Malaysia. We have grown these brands by providing premium and consistent quality products and superior customer service. We have more than 80 service centers in over 23 countries and serve over 30,000 customers.
29/11/2024 Dissemination of a Financial Press Release, transmitted by EQS News. Media archive at www.todayir.com |
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Asklepios Group: Consistent growth in first nine months of 2024
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EQS-News: Asklepios Kliniken / Key word(s): 9 Month figures/Quarterly / Interim Statement Asklepios Group: Consistent growth in first nine months of 2024 28.11.2024 / 10:00 CET/CEST The issuer is solely responsible for the content of this announcement. Asklepios Group: Consistent growth in first nine months of 2024
Hamburg, 28 November 2024. Asklepios Kliniken GmbH & Co. KGaA has generated stable growth over the first nine months of 2024. In a volatile macro-economic and healthcare policy environment, Asklepios has managed to increase its treatment numbers once more and to achieve positive consolidated earnings. The refinancing is an important step for further integrating sustainability initiatives into the Group’s financing strategy. Between January and September 2024, Asklepios Group’s healthcare facilities treated a total of 2,742,439 patients (9M 2023: 2,587,813) – around 6% more than in the same period the previous year. This positive trend underlines the trust that patients have in the medical services provided by Asklepios Kliniken. The number of full-time employees was slightly up on the previous year’s level at 50,398 (9M 2023: 49,689). The Asklepios Group generated consolidated earnings of EUR 4,350.8 million across the first nine months of 2024 (9M 2023: EUR 4,077.7 million). Consolidated earnings after tax (EAT) for the period January to September 2024 were slightly higher than in the same period the previous year at EUR 88.2 million (9M 2023: EUR 81.9 million). The EAT margin remained stable at 2.0% (9M 2023: 2.0%). The Asklepios Group is employing new refinancing instruments as part of its Social Finance Framework in order to remain flexible in the face of changes in the market landscape. This move allows proceeds to be fed back into the social healthcare infrastructure. We were able to raise the issuing volume from EUR 250.0 million to a total of EUR 500.0 million. Hafid Rifi, CFO of Asklepios Kliniken: “Conducted within our Social Finance Framework, this round of financing will allow us to react flexibly in a volatile landscape. The high issuing volume indicates the trust investors have in our journey and strengthens Asklepios’ position as a trustworthy healthcare services provider.” As part of a strong network with MEDICLIN and RHÖN, the Asklepios Group is confident about the remainder of the financial year 2024. The Group is in a solid position for pursuing its strategic goals with consistency. About Asklepios Asklepios Kliniken is one of the leading private operators of hospitals and healthcare facilities in Germany. The hospital group stands for highly qualified care for its patients with a clear commitment to medical quality, innovation and social responsibility. On the basis of this, Asklepios has developed dynamically since it was founded more than 35 years ago. The group currently has 164 healthcare facilities across Germany. These include acute hospitals at all levels of care, university hospitals, specialist clinics, psychiatric and forensic facilities, rehabilitation clinics, care homes and medical centres. In the financial year 2023, over 3.5 million patients were treated in Asklepios Group facilities. The company has more than 68,000 employees. IR Contact: PR Contact: Find Asklepios online, on Facebook or on YouTube: Sign up for the Asklepios Newsletter:
28.11.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
Formycon reports nine-month results for 2024 and continues growth trajectory with further operational successes
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EQS-News: Formycon AG / Key word(s): 9 Month figures/Quarterly / Interim Statement Formycon reports nine-month results for 2024 and continues growth trajectory with further operational successes 28.11.2024 / 06:30 CET/CEST The issuer is solely responsible for the content of this announcement.
Press Release // November 28, 2024 Formycon reports nine-month results for 2024 and continues growth trajectory with further operational success
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today reported on the financial results and business performance of the Formycon Group for the first nine months of fiscal year 2024. “We can look back on an extremely successful business performance in the first nine months of fiscal year 2024 and have met all operational, clinical and regulatory targets. In the third quarter of 2024, we were able to announce the EMA and FDA approvals for FYB202/Otulfi®1, which followed in quick succession. This also triggered two milestone payments from our partner Fresenius Kabi. We are equally pleased about the EMA’s Committee for Medicinal Products for Human Use (CHMP) positive opinion for FYB203/AHZANTIVE®2/Baiama®3, which once again underscores the excellent quality of our data, processes and products. Our biosimilar FYB201, approved in 2022, was able to further expand its strong market position in the key markets USA and UK during the course of this financial year, gaining impressive market shares. At the same time, we achieved a groundbreaking development milestone with our Keytruda®4 biosimilar candidate by including the first patients in our clinical program for FYB206, thereby consolidating our position among the leading developers for this product. Thanks to our development expertise and agility, we are ideally placed to position Formycon AG as a leading independent provider of high-quality biosimilars in the market,” says Dr. Stefan Glombitza, CEO of Formycon AG. Enno Spillner, CFO of Formycon AG, adds: ”After a great deal of intensive preparation, we completed the final step necessary for entry into the Prime Standard in the third quarter of 2024. This uplisting to the regulated market of the Frankfurt Stock Exchange in mid-November marks a significant chapter in our capital market strategy. It gives us access to a broader range of international and institutional investors. This increases our attractiveness to the capital market and strengthens our position in international competition.” Operational success and progress in the second half of the year underpin growth strategy FYB201 Lucentis®5 biosimilar Formycon’s FYB201 (ranibizumab), available in the United States under the tradename CIMERLI®6, has captured a significant share of the overall U.S. Lucentis® market. Following the strategic realignment of Formycon’s distribution partner Coherus BioSciences, Inc. (Coherus), the marketing rights for CIMERLI®, including the Coherus ophthalmology sales team, were transferred to Sandoz AG on March 1, 2024. According to market reports, CIMERLI®‘s market share in the US ranibizumab market was over 40% in August. In the United Kingdom, FYB201/ONGAVIA®7 has a market share of over 80% based on indication-based market volume and thus has a dominant market position. In addition, further markets such as Canada and Saudi Arabia have been tapped in the current fiscal year. FYB201 is now available in a total of 20 countries worldwide. FYB202 Stelara®8 biosimilar At the end of September 2024, both the U.S. Food and Drug Administration (FDA) and the European Commission granted approval for FYB202/Otulfi®, Formycon’s ustekinumab biosimilar, for the treatment of severe inflammatory diseases such as Crohn’s disease, moderate to severe plaque psoriasis, and active psoriatic arthritis. A settlement agreement had already been concluded between Formycon, Fresenius Kabi and Johnson & Johnson, granting Formycon’s marketing partner Fresenius Kabi the right to launch Otulfi® in the USA no later than February 22, 2025. A further agreement governs the launch of the biosimilar in Europe and Canada, the terms of which remain confidential. The European Commission’s approval covers both subcutaneous and intravenous formulations and is valid in all countries of the European Economic Area (EEA), including the 27 EU member states, Iceland, Liechtenstein and Norway. FYB203 Eylea®9-Biosimilar On November 15, 2024 (after the reporting period), the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of FYB203, a biosimilar to Eylea® (aflibercept), under the brand names AHZANTIVE® and Baiama®. The recommendation includes the treatment of neovascular age-related macular degeneration (nAMD) as well as other serious eye diseases such as diabetic macular edema (DME), diabetic retinopathy (DR) and macular edema secondary to retinal vein occlusion (RVO). The final decision of the European Commission is expected in the second half of January 2025. The FDA had already approved FYB203/AHZANTIVE® in the US for the same indications on June 28, 2024. With these advances, Formycon is on track to make FYB203 available in both the US and Europe as a cost-effective treatment alternative for patients with severe retinal diseases. FYB206 Keytruda® biosimilar candidate Another important operational milestone was reached with the start of the clinical development program for FYB206, a biosimilar candidate for the immuno-oncology blockbuster drug Keytruda®. The first patient was enrolled in the phase I study to compare the pharmacokinetics (PK), safety and tolerability of FYB206 with the reference drug Keytruda® in patients with malignant melanoma (black skin cancer) in June 2024. The parallel phase III study comparing the safety and efficacy of FYB206 with Keytruda® in patients with non-small cell lung cancer (NSCLC) started at the end of July 2024. The scientific basis for the ongoing clinical trials is provided, among other things, by the results of an analytical study comparing FYB206 with Keytruda®, which were published in October 2024 in the peer-reviewed journal Drugs in R&D. The results confirmed a high degree of structural and functional similarity between FYB206 and the reference medicine. With the start of the study, Formycon is consolidating its excellent position in the leading group of developers of pembrolizumab biosimilars. FYB208 / FYB209 – early biosimilar candidates and further development of the pipeline Formycon is continuously investing in the expansion of its biosimilar platform and has further expanded its product pipeline with the two younger biosimilar candidates FYB208 and FYB209. For both candidates, cell lines with convincing stability, productivity and quality have been identified and transferred to manufacturing partners for further process development and scale-up. FYB210 – a new biosimilar candidate in the pipeline in the field of immunology Following a complex selection process, a further biosimilar candidate FYB210 was recently launched (after the reporting period). Following the official start of the development process, FYB210 is now the seventh biosimilar project in Formycon’s development pipeline and is positioned in the immunology indication area. It addresses an attractive and strongly growing therapeutic area with the aim of commercialization after the loss of exclusivity rights after 2030. Key personnel appointment and promotion to a higher stock exchange segment confirm strategic direction Formycon has a highly experienced management team with many years of industry expertise. To ensure continuity in the company’s successful management, the management contract of CEO Dr. Stefan Glombitza has been extended until December 2027 (after the reporting period). In addition, on November 11 (after the reporting period), Formycon successfully completed its uplisting to the Prime Standard of the Frankfurt Stock Exchange, the segment with the highest transparency requirements on the Deutsche Börse. This step marks a significant milestone in the company’s capital market strategy. The Prime Standard requires strict disclosure and reporting obligations and is an important prerequisite for investment decisions by institutional and international investors. This uplisting also lays the foundation for a potential inclusion in important indices, such as the SDax or TechDax; it strengthens the company’s visibility and transparency in the global capital markets. Formycon Group revenue and EBITDA remain in line with planning The Formycon Group’s revenue for the first nine months of 2024 was around €41.1 million (9M/2023: €60.2 million), in line with expectations. These revenues include both income from the marketing of FYB201 and revenues from development services for the partnered or out-licensed biosimilar candidates FYB201 and FYB203. In addition, milestone payments from the commercialization partnership for FYB202 with Fresenius Kabi AG (Fresenius Kabi) were recognized on a pro-rata basis, a portion of which had already been deferred in 2023. The commercialization of the ranibizumab biosimilar FYB201, which was launched in further markets in the first nine months, is developing very positively in terms of sales figures. Revenues from the direct participation in the commercialization of this Lucentis® biosimilar increased to around €6.0 million (9M/2023: €2.3 million). The significant portion of the contribution of earnings from FYB201 is realized in the context of the 50% at-equity investment in Bioeq AG and is therefore not directly reflected in revenues, but below EBITDA (see below). As of the September 30, 2024 reporting date, it amounted to a total of €20.6 million and is reflected accordingly in the adjusted EBITDA. Consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to around €-17.7 million in the first nine months (9M/2023: €5.2 million) and are in line with planning. This result was due to lower revenues, a planned and significant increase in research and development costs due to the rapid progress of FYB208 and FYB209, but also higher administrative costs due to the preparation and execution of the uplisting. Adjusted group EBITDA reflects strong FYB201 performance The adjusted Group EBITDA aims to present the total income from the FYB201 project, which is partially recognized as equity-accounted income below EBITDA due to the existing 50% stake in Bioeq AG, as regular operating income. It shows the direct financial contributions of FYB201 to the business success of the Formycon Group and the actual operating performance of the company. Adjusted consolidated EBITDA for the first nine months of 2024 amounted to €2.9 million (9M/2023: €3.5 million). This is due in particular to the good performance of FYB201 and the resulting significant increase in the earnings contribution from Bioeq AG (at equity earnings) of €20.6 million (9M/2023: € -1.7 million). Working capital increase due to higher cash and receivables The net working capital of the Formycon Group amounted to €65.8 million as of September 30, 2024 (September 30, 2023: €41.3 million) and includes cash and cash equivalents of €33.8 million (September 30, 2023: €35.6 million). The working capital includes two milestone payments from Fresenius Kabi, which were recognized in receivables earlier than expected due to the already granted EU approval for FYB202 but are not due for payment until the fourth quarter. The existing shareholder loan of €48.0 million was extended. The credit line remains fully available and can be utilized flexibly until May 2026. Forecast for the Formycon Group for the full year 2024 remains unchanged For the fourth quarter, Formycon expects business to continue as planned. In addition to further operational progress with the biosimilar candidates, revenues are expected to be slightly higher than the average of the first three quarters. The milestone payments received from Fresenius Kabi for the approvals of FYB202 will lead to a stable cash position in the fourth quarter. The guidance for the full year 2024, which was already revised upwards for adjusted EBITDA and working capital in the context of the half-year results, is thus confirmed.
Conference Call and Webcast The Executive Board of Formycon AG will discuss the company’s performance and key financial figures, as well as the recent uplisting to the Prime Standard of the Frankfurt Stock Exchange, in a conference call. The earnings call, which will be webcast live, will take place in English on November 28, 2024 at 3:00 p.m. (CET). To participate in the conference call, please register at: https://webcast.meetyoo.de/reg/TkZPrWBERFjh After registration, participants will receive a confirmation email with individual dial-in data. The presentation and audio broadcast can be accessed via the following webcast link: After a brief presentation, the Management Board will be available for analysts’ questions. The conference call will be recorded and can subsequently be accessed via the Formycon website at: https://www.formycon.com/en/investor-relations/publications/ 1) Otulfi® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries 2) AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH 3) Baiama® is a registered trademark of Klinge Biopharma GmbH 4) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA 5) Lucentis® is a registered trademark of Genentech Inc. 6) CIMERLI® is a registered trademark of Coherus BioSciences, Inc. 7) ONGAVIA® is a registered trademark of Teva Pharmaceutical Industries 8) Stelara® is a registered trademark of Johnson & Johnson 9) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
About Formycon About Biosimilars: Contact: Disclaimer:
28.11.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
| Language: | English |
| Company: | Formycon AG |
| Fraunhoferstraße 15 | |
| 82152 Planegg-Martinsried | |
| Germany | |
| Phone: | 089 864667 100 |
| Fax: | 089 864667 110 |
| Internet: | www.formycon.com |
| ISIN: | DE000A1EWVY8 |
| WKN: | A1EWVY |
| Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange |
| EQS News ID: | 2039871 |
| End of News | EQS News Service |
Marinomed Biotech AG: Binding Term Sheet for the intended issuance of a convertible bond to the European Investment Bank (EIB) signed
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Marinomed Biotech AG / Key word(s): Corporate Action Marinomed Biotech AG: Binding Term Sheet for the intended issuance of a convertible bond to the European Investment Bank (EIB) signed 27-Nov-2024 / 13:34 CET/CEST Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. Korneuburg, Austria, 27. November 2024 – Marinomed Biotech AG (the “Company”) announces that it has signed a binding term sheet with the European Investment Bank (EIB) for the intended issuance of a convertible bond (registered bond in the name or order) with a nominal value of EUR 423,840, which is to be subscribed exclusively by the European Investment Bank (EIB) (excluding the statutory subscription rights of existing shareholders) against the contribution of a right of segregation. The convertible bond will evidence a conversion right in initially up to 84,768 shares of the Company at a conversion price of EUR 5 per share and will be issued in December 2024. In the event of conversion of the convertible bond, it is intended to issue the shares available from the conditional capital of the Company. A corresponding report on the planned exclusion of the statutory subscription rights of existing shareholders to convertible bonds will be published shortly. The required resolution of the Supervisory Board on the issuance of the convertible bond with the exclusion of subscription rights can be adopted at the earliest two weeks after publication of the report. The necessary consent of the insolvency administrator for the issuance of the convertible bond has not yet been obtained.
+++ End of ad-hoc announcement +++ End of Inside Information 27-Nov-2024 CET/CEST News transmitted by EQS Group AG. www.eqs.com |
| Language: | English |
| Company: | Marinomed Biotech AG |
| Hovengasse 25 | |
| 2100 Korneuburg | |
| Austria | |
| Phone: | +43 2262 90300 |
| E-mail: | office@marinomed.com |
| Internet: | www.marinomed.com |
| ISIN: | ATMARINOMED6 |
| WKN: | A2N9MM |
| Listed: | Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt, Munich, Stuttgart, Tradegate Exchange; Vienna Stock Exchange (Official Market) |
| EQS News ID: | 2039579 |
| End of Announcement | EQS News Service |
Marinomed Biotech AG: Publication of a report on the exclusion of subscription rights for a possible second cash capital in-crease of up to 154,053 shares
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Marinomed Biotech AG / Key word(s): Corporate Action/Capital Increase Marinomed Biotech AG: Publication of a report on the exclusion of subscription rights for a possible second cash capital in-crease of up to 154,053 shares 27-Nov-2024 / 12:49 CET/CEST Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. Korneuburg, Austria, 27. November 2024 – As Marinomed Biotech AG (the “Company” or “Marinomed”) announced in its ad hoc announcement dated 18 September 2024 regarding the first cash capital increase of 154,053 new shares (the “First Cash Capital Increase”), the Company is negotiating with investors regarding a possible second cash capital increase, which would be carried out in accordance with the authorisation to exclude the subscription rights of existing shareholders (the “Second Capital Increase”). Marinomed is currently continuing to discuss with several investors such a Second Capital Increase, although no agreements or board resolutions have yet been reached.
The Company’s Management Board has resolved today to publish a report on the intended exclusion of subscription rights of existing shareholders for a possible cash capital increase of up to EUR 154,053 by issuing up to 154,053 new no-par value bearer shares against cash contribution (the “Report”). The Report on the exclusion of subscription rights is to be published as soon as possible on the electronic announcement and information platform of the Federal Government of Austria (“EVI”). With the publication of the Report, the Company’s Management Board ensures that, in the event of a short-term financing requirement of the Company, the Company’s Management Board is legally in a position to resolve on a new cash capital increase from the authorised capital 2024 in accordance with § 5 para (6) of the Company’s Articles of Association (the “Authorised Capital 2024”) at short notice with the approval of the Supervisory Board. The background to this is that a report on the planned exclusion of subscription rights must be published at least two weeks prior to the required Supervisory Board resolution. Against the background of the cash ratio to be deposited in accordance with the adopted restructuring plan, the Company is creating the prerequisite for being able to raise necessary equity at short notice and not having to wait for the two-week period to expire in this case. The actual implementation of a possible Second Capital Increase remains dependent on the outcome of negotiations with investors, the conclusion of the respective transaction documents and the adoption of resolutions by the Company’s Management Board and Supervisory Board. In addition, the restructuring proceedings (still needed for a Second Capital Increase) require the approval by the restructuring administrator. +++ End of ad-hoc announcement +++
End of Inside Information 27-Nov-2024 CET/CEST News transmitted by EQS Group AG. www.eqs.com |
| Language: | English |
| Company: | Marinomed Biotech AG |
| Hovengasse 25 | |
| 2100 Korneuburg | |
| Austria | |
| Phone: | +43 2262 90300 |
| E-mail: | office@marinomed.com |
| Internet: | www.marinomed.com |
| ISIN: | ATMARINOMED6 |
| WKN: | A2N9MM |
| Listed: | Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt, Munich, Stuttgart, Tradegate Exchange; Vienna Stock Exchange (Official Market) |
| EQS News ID: | 2039559 |
| End of Announcement | EQS News Service |
Grünenthal announces pricing of €500 million bond
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EQS-News: Grünenthal GmbH / Key word(s): Issue of Debt/Bond Grünenthal announces pricing of €500 million bond 27.11.2024 / 09:35 CET/CEST The issuer is solely responsible for the content of this announcement. NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES, AUSTRALIA, CANADA OR JAPAN, OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.
Grünenthal announces pricing of €500 million bond Aachen, Germany, 27 November 2024 – Grünenthal GmbH (the “Company”) announces the pricing of €500 million aggregate principal amount of 4.625% senior secured notes due 2031 (the “Notes”). The Notes will be issued at 100.0%. The Notes were offered outside the United States in reliance on Regulation S under the Securities Act of 1933, as amended (the “Securities Act”). In the United States, the Notes were offered only to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The Notes were rated ‘BB+’, ‘BB-‘ and ‘B1’ by the three major independent credit rating agencies Fitch Ratings, Standard & Poor’s and Moody’s Investors Service respectively. This new financing will enhance Grünenthal’s capital structure and its maturity profile. The Company will use the proceeds from the Notes to refinance the €100 million outstanding under its revolving credit facility and to repurchase its outstanding notes due 2026 held in reliance on Regulation S under the Securities Act. This Notes issue follows Grünenthal successfully extending the maturity and upsizing of its €600 million revolving credit facility in November. The offering of the Notes is expected to close on 6 December 2024. — These materials are not an offer for sale of securities. The offering is being made by means of an offering memorandum. This announcement does not constitute an offer to sell or the solicitation of an offer to buy the Notes or any other security and shall not constitute an offer, solicitation or sale in the United States or in any jurisdiction in which, or to any persons to whom, such offering, solicitation or sale would be unlawful. The Notes and the related guarantees have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”) or the securities laws of any state or other jurisdiction of the United States, and may not be offered or sold within the United States, or to, or for the account or benefit of, U.S. persons, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state or local securities laws. Accordingly, the Notes and the related guarantees are being offered and sold (i) in the United States only to qualified institutional buyers in accordance with Rule 144A under the Securities Act and (ii) in “offshore transactions” to non-U.S. persons outside the United States in accordance with Regulation S under the Securities Act. This communication is only being distributed to and is only directed at (i) persons who are outside the United Kingdom, (ii) persons who are investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”), (iii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the Order, or (iv) any persons to whom an invitation or inducement to engage in investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000) in connection with the issue or sale of any securities may otherwise lawfully be communicated or cause to be communicated (all such persons together being referred to as “relevant persons”). The investments to which this press release relates are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this press release or any of its contents. The offer and sale of the Notes will be made pursuant to an exception under the Prospectus Regulation from the requirement to produce a prospectus for offers of securities. This press release does not constitute a prospectus within the meaning of the Prospectus Regulation or an offer to the public. Manufacturer target market (MIFID II product governance) is eligible counterparties and professional clients only (all distribution channels). No PRIIPs key information document (KID) has been prepared as not available to retail investors in EEA. The distribution of this press release into certain jurisdictions may be restricted by law. Persons into whose possession this announcement comes should inform themselves about and observe any such restrictions. Any failure to comply with these restrictions may constitute a violation of the laws of any such jurisdiction.
Forward-looking statements This news release may include “forward-looking statements” within the meaning of the securities laws of certain applicable jurisdictions. These forward-looking statements include, but are not limited to, all statements other than statements of historical facts contained in this news release, including, without limitation, those regarding the Company’s intentions, beliefs or current expectations concerning, among other things: the Company’s future financial conditions and performance, results of operations and liquidity; the Company’s strategy, plans, objectives, prospects, growth, goals and targets and future developments in the markets in which the Company participates or is seeking to participate. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate”, “believe”, “continue”, “ongoing”, “estimate”, “expect”, “intend”, “may”, “plan”, “potential”, “predict”, “project”, “target”, “seek” or, in each case, their negative, or other variations or comparable terminology. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors because they relate to events and depend on circumstances that may or may not occur in the future. Readers are cautioned that forward-looking statements are not guarantees of future performance and that the Company’s actual financial condition, results of operations and cash flows, and the development of the industry in which the Company operates, may differ materially.
About Grünenthal Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated 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 27 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2023, Grünenthal employed around 4,400 people and achieved revenues of €1.8 billion.
More information: www.grunenthal.com Follow us on: LinkedIn: Grunenthal Group Instagram: grunenthal
For further information, please contact:
27.11.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
| Language: | English |
| Company: | Grünenthal GmbH |
| Zieglerstraße 6 | |
| 52099 Aachen | |
| Germany | |
| Phone: | 0241-569-0 |
| E-mail: | communications@grunenthal.com |
| ISIN: | XS2337703537, XS2337064856 |
| WKN: | A3E5QA , A3E5QC |
| Listed: | Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt, Munich, Stuttgart, Tradegate Exchange |
| EQS News ID: | 2038911 |
| End of News | EQS News Service |
Eckert & Ziegler Achieves European Approval for Theralugand® – Lutetium-177 Chloride (n.c.a)
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EQS-News: Eckert & Ziegler SE / Key word(s): Regulatory Approval/Market Launch Eckert & Ziegler Achieves European Approval for Theralugand® – Lutetium-177 Chloride (n.c.a) 27.11.2024 / 09:00 CET/CEST The issuer is solely responsible for the content of this announcement. Berlin, 27 November 2024. Eckert & Ziegler Radiopharma GmbH (Eckert & Ziegler) today received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand®, by the European Commission (EC). This enables the use of the radiopharmaceutical medicinal product Theralugand® in routine clinical applications throughout the European Economic Area (EEA). Theralugand® provides high-purity Lutetium-177 produced in compliance with GMP standards with specifications designed for the labelling of therapeutic radiopharmaceuticals. The approval unlocks its potential to support innovative cancer therapies such as those targeting neuroendocrine tumors and metastatic prostate cancer. The previous, GMP-certified Lutetium-177 was limited to investigational use in clinical studies. Eckert & Ziegler collaborates with pharmaceutical companies worldwide to develop and manufacture Lutetium-177-based radiopharmaceuticals, furthering the reach of targeted radiotherapies for the global market. Through these partnerships, Eckert & Ziegler plays a vital role in providing innovative cancer treatments. “We are excited to achieve the EC approval for Theralugand®, a critical step in making innovative treatment options widely available for clinical applications across Europe,” said Dr. Harald Hasselmann, CEO of Eckert & Ziegler SE. “This accomplishment reflects our dedication to the production and distribution of reliable therapeutic radiopharmaceuticals.” Eckert & Ziegler is gearing up to meet the rising global demand for Lutetium-177 by actively expanding production capacities, ensuring a stable supply of this critical therapeutic radioisotope. About Eckert & Ziegler SE Contact
27.11.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
| Language: | English |
| Company: | Eckert & Ziegler SE |
| Robert-Rössle-Str.10 | |
| 13125 Berlin | |
| Germany | |
| Phone: | +49 30 941084-138 |
| Fax: | +49 30 941084-0 |
| Internet: | www.ezag.de |
| ISIN: | DE0005659700 |
| WKN: | 565970 |
| Indices: | SDAX, TecDax, |
| Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange |
| EQS News ID: | 2036955 |
| End of News | EQS News Service |
Marinomed Biotech AG signs agreement for sale of Carragelose business to French Unither Pharmaceuticals
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Marinomed Biotech AG / Key word(s): Disposal/Strategic Company Decision Marinomed Biotech AG signs agreement for sale of Carragelose business to French Unither Pharmaceuticals 26-Nov-2024 / 21:14 CET/CEST Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. Korneuburg, Austria, November 26, 2024 – Marinomed Biotech AG (the “Company”) announces the signing of an agreement for the sale of its Carragelose business to French Unither Pharmaceuticals (“Unither”), a leading contract development and manufacturing organization (CDMO) of medical devices and pharmaceutical products. The contract provides for upfront and milestone payments of total up to EUR 20 million, depending on the achievement of defined commercial and operational targets, over the next two years. As part of the agreement, Marinomed and Unither intend to enter into a transition service agreement at completion of such transaction. The proceeds from the sale of the Carragelose business are planned to finance both the operating business, with increased focus on the Marinosolv platform, and the restructuring plan agreed upon with the Company’s creditors on November 14, 2024. The closing of the contract is inter alia subject to the successful completion of the restructuring proceedings, the approval by the Company’s Supervisory Board and shareholders at an extraordinary general meeting.
+++ End of ad-hoc announcement +++ End of Inside Information 26-Nov-2024 CET/CEST News transmitted by EQS Group AG. www.eqs.com |
| Language: | English |
| Company: | Marinomed Biotech AG |
| Hovengasse 25 | |
| 2100 Korneuburg | |
| Austria | |
| Phone: | +43 2262 90300 |
| E-mail: | office@marinomed.com |
| Internet: | www.marinomed.com |
| ISIN: | ATMARINOMED6 |
| WKN: | A2N9MM |
| Listed: | Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt, Munich, Stuttgart, Tradegate Exchange; Vienna Stock Exchange (Official Market) |
| EQS News ID: | 2038823 |
| End of Announcement | EQS News Service |
Immunic, Inc. to Participate in Investor Conference in December
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Issuer: Immunic AG / Key word(s): Conference 26.11.2024 / 12:30 CET/CEST The issuer is solely responsible for the content of this announcement. Immunic, Inc. to Participate in Investor Conference in December NEW YORK, November 26, 2024 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will participate in a fireside chat on Thursday, December 5, 2024, at 11:30 am ET, during the Piper Sandler 36th Annual Healthcare Conference, taking place December 3-5, 2024, in New York. Dr. Vitt, Glenn Whaley, Chief Financial Officer, and Jessica Breu, Vice President Investor Relations and Communications, will also participate in one-on-one investor meetings at the conference. To schedule a meeting, please contact your Piper Sandler representative or Jessica Breu at: jessica.breu@imux.com. A webcast of the event will be available on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations. An archived replay will be available on the company’s website for a period of 90 days after the conference. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to management’s and employee’s participation in investor conferences. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, including the ability to satisfy the minimum average price and trading volume conditions required to receive funding in tranche 2 and 3 of the January 2024 private placement, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release. Contact Information Immunic, Inc. US IR Contact US Media Contact
Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
Viromed Medical AG: cold plasma as a digital antibiotic for the lungs
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EQS-News: Viromed Medical AG / Key word(s): Study Viromed Medical AG: cold plasma as a digital antibiotic for the lungs 26.11.2024 / 08:00 CET/CEST The issuer is solely responsible for the content of this announcement. Viromed Medical AG: cold plasma as a digital antibiotic for the lungs
Pinneberg, 26 November 2024 – Viromed Medical AG (Ticker: VMED; ISIN: DE000A3MQR65; “Viromed”) is pushing forward research into cold plasma for the prevention of ventilator-associated pneumonia (VAP). Under the scientific direction of the outstanding expert Prof. Dr. Hortense Slevogt, BREATH scientist at the Hannover Medical School, the innovative project is investigating the safety and efficacy of cold plasma to kill bacteria in the respiratory tract for approval as a therapy. The official announcement of the BREATH research network in this regard was published on November 22, 2024. The renowned expert network BREATH (Biomedical Research in End-stage and Obstructive Lung Disease Hannover) is one of the five sites of the German Center for Lung Research (DZL) and uniquely unites internationally recognized expertise in translational respiratory medicine. The research network consists of the four strong partners Hannover Medical School, Leibniz Universität Hannover, Fraunhofer ITEM and CAPNETZ FOUNDATION. VAP is a common and serious complication in mechanically ventilated patients, occurring in patients who are invasively ventilated for at least 48 hours. Studies show that VAP affects 23–36% of mechanically ventilated patients and is associated with prolonged ventilation, extended ICU and hospital stays, and an estimated mortality rate of 10–13%. In Germany alone, approximately 486,000 patients required mechanical ventilation in ICUs in 2023, highlighting the need for VAP prevention measures. Uwe Perbandt, CEO of Viromed Medical AG, explained: “Even in the past, people often did not die from injuries but from the infections that followed. Today, we are heading towards a similar scenario. Due to the increasing resistance of germs, many people can no longer be helped. An infection is synonymous with death. Furthermore, antibiotics in the human body sometimes take days to reach the source of the disease. We do not have these problems with cold plasma. It can reach the site of infection within a few minutes and destroy pathogens – including those that are already resistant to antibiotics – just as quickly. The most important advantage is that cold plasma destroys germs physically. And there can be no resistance to that. So, if the efficacy and safety of cold plasma continue to be confirmed in the course of the study, which I firmly believe they will, we have here, in effect, a ‘digital antibiotic’ that will take us a big step forward in the fight against many diseases. This way, we can save tens or even hundreds of thousands of lives. In my opinion, this asset can increase the value of the AG significantly. Since BREATH published the news on Friday, we have already received numerous international inquiries.” Prof. Dr. Hortense Slevogt, Clinic for Pneumology and Infectiology, MHH: “Ventilator-associated pneumonia not only has a high mortality rate but also places a significant burden on the healthcare system due to increased antibiotic use, longer patient stays, and higher treatment costs. The growing antibiotic resistance of pathogens makes new, non-antibiotic approaches urgently necessary. If the positive preliminary results of our study are confirmed, cold plasma could revolutionize the treatment of ventilated patients.”
About Viromed Medical AG: Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region, including DAX companies such as Volkswagen and Lufthansa, state and federal authorities and ministries as well as 1,100 hospitals, 7,000 pharmacies and 11,000 medical practices. Cold atmospheric plasma (CAP) has been scientifically proven to inactivate harmful viruses, fungi and bacteria and has the potential to revolutionize conventional treatment methods in a wide variety of areas. Viromed Medical AG is doing important pioneering work in this field. The clearly superior CAP is already being used to treat difficult-to-heal wounds. Viromed is currently conducting clinical trials for use in pulmonary medicine. Viromed Medical AG is pursuing the goal of further advancing the use of CAP in medicine in the coming years and realizing the corresponding growth potential.
Contact Viromed Medical AG Uwe Perbandt
26.11.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
| Language: | English |
| Company: | Viromed Medical AG |
| Flensburger Straße 18 | |
| 25421 Pinneberg | |
| Germany | |
| Phone: | +49 4101 809960 |
| E-mail: | kontakt@viromed-medical.de |
| Internet: | https://www.viromed-medical-ag.de/ |
| ISIN: | DE000A3MQR65 |
| WKN: | A3MQR6 |
| Listed: | Regulated Unofficial Market in Berlin, Dusseldorf (Primärmarkt), Frankfurt (Basic Board), Hamburg |
| EQS News ID: | 2037893 |
| End of News | EQS News Service |