Korneuburg, Austria, November 14, 2024 – Marinomed Biotech AG (VSE:MARI) announces that the creditors’ assembly unanimously approved the restructuring plan presented at the final court hearing at the Korneuburg Regional Court on November 14, 2024. The established quota is 30%, payable in several tranches within two years. 5% is to be deposited as a cash quota. The liquidity required for the repayment of the quotas is to be partially funded through the sale of the Carragelose business unit of Marinomed Biotech AG. A super quota of up to a further 7% will be distributed if milestone payments from the sale of the Carragelose business within two years exceed the planned amount. Confirmation of the restructuring plan and termination of the proceedings are subject, among other things, to the payment of the 5% cash deposit and a standstill declaration from the European Investment Bank (EIB). The Company will provide information on further developments.

+++ End of ad-hoc announcement +++ 

The acquisition of WEECO Pharma by the European hemp and cannabis group SYNBIOTIC SE (ISIN DE000A3E5A59 | WKN A3E5A5) is proving to be a valuable deal in the truest sense of the word. WEECO Pharma is well above the previously planned revenue target for 2024, at EUR 6.75 million as of the end of October 2024. Revenues of over EUR 8 million are expected for the full year 2024. For this reason, WEECO Pharma’s sales plans for 2025 and 2026 will be realistically, but still conservatively, adjusted upwards in the coming weeks.

“We firmly believed that our partnership would create positive synergies for both sides. Despite our great confidence, we would never have dreamt that we would be able to present such figures so soon. The whole is indeed more than the sum of its parts,” explain Börge Diessel, Managing Director of WEECO Pharma, and Daniel Kruse, CEO of SYNBIOTIC.

As a German importer and wholesaler, WEECO Pharma brings together an international network of medical cannabis producers, including some of the world’s leading EU GMP manufacturers. The company specialises in the national and international trade in medicinal cannabis, including proprietary genetics. With WEECO Pharma, SYNBIOTIC has a full range of high-quality cannabis flowers within the group of companies. WEECO Pharma benefits from proven structures, experienced managers and contacts with suppliers from other SYNBIOTIC subsidiaries, specifically MH medical hemp and SynBiotic Distribution. This enables the group to fully exploit its potential. At the same time, SYNBIOTIC is planning further acquisitions in the areas of cultivation and the supply chain for medical cannabis.

“WEECO has developed into a real asset for our investors and shareholders in a very short space of time,” confirms Daniel Kruse. “Over the next 18 months, we will increasingly focus on the extremely growing market for medical cannabis.”

And this is also fuelling current discussions with potential investors. SYNBIOTIC’s Investor Relations team is using the good news for an extended November roadshow.

SYNBIOTIC On the Road Again

mwb research from Hamburg, one of the largest analysis firms in Europe, organised an exclusive online presentation for investors at the launch. Daniel Kruse presented SYNBIOTIC’s strategy together with Lukas Kendel and Emilio Ropero from SYNBIOTIC’s management team and answered questions from selected investors.

As part of the Talman event “Shape the Future of Cannabis Investment” in Munich, Daniel Kruse discussed investment opportunities in the emerging legal cannabis industry as a panellist with other experts from the cannabis industry. The Talman House is a members-only service that connects investors with successful cannabis companies in Europe and around the world. SYNBIOTIC also supported the event on the second weekend of November as a Gold Sponsor.

From 25 to 27 November, SYNBIOTIC’s IR team, headed by Daniel Kruse, will be a guest at the German Equity Forum. The event, organised by Deutsche Börse AG, is one of the most important capital market events about corporate financing in Europe. At the Steigenberger Airport Hotel Frankfurt, institutional investors and financial analysts enter dialogue with around 250 listed companies. In addition to SYNBIOTIC, there are also several DAX-listed companies on the list of registered companies.

Diversity advantage

As a European industrial hemp and cannabis group, SYNBIOTIC has a decisive unique selling point: no market competitor offers investors a comparably high degree of diversification in the industrial hemp and cannabis sector. Through its investments, SYNBIOTIC covers the entire value chain of the industrial hemp and cannabis sector. The successful continuation of the buy and build strategy will further extend this advantage.

Publisher
SYNBIOTIC SE
Daniel Kruse
CEO
Münsterstraße 336
40470 Düsseldorf
Germany

Media contact
Rüdiger Tillmann
SYNBIOTIC
Public Relations Manager
E-mail ruediger.tillmann@synbiotic.com
Mobile +49 170 9651451
c/o JOLE.group

About SYNBIOTIC
SYNBIOTIC is a listed group of companies in the hemp and cannabis sector and pursues a buy and build investment strategy focussed on the EU. 
The Group covers the entire value chain from cultivation to production and retail – from the field to the shelf. The core businesses of the vertically integrated subsidiaries are research and development, production and the commercialisation of hemp, CBD and cannabis products.
SYNBIOTIC has a clear pan-European strategy to further expand along the value chains of its business areas – hemp and CBD, medical cannabis and consumer cannabis.

PRESS RELEASE

Biotest increases revenues in the first 9 months by 4.5% to Euro 523 million

 

• Product sales and toll manufacturing increased by 13,7% to € 414 million, in part thanks to the growth of Yimmugo^®
• Adjusted EBIT was maintained at previous year’s level as growing core business gradually replaces earnings  from technology transfer and development services
• Biotest submitted initial marketing authorization application for its Fibrinogen Concentrate (BT524) following the decentralized procedure for approval in Germany, Austria and Spain
• Guidance for revenue, cash flow and ROCE corrected
• EBIT guidance remains unchanged

 

Dreieich, Germany, November 14, 2024. The Biotest Group generated sales of € 522.7 million in the first nine months of the financial year 2024. This corresponds to an increase of 4.5% compared to the same period of the previous year (€ 500.3 million). Revenue from products and toll manufacturing increased by € 49.9 million or 13.7%, to € 414.4 million. In addition, revenue from technology disclosure and development services for Grifols, S.A. as part of the technology transfer and license agreement amounted to € 108.3 million, compared to € 135.4 million in the same period of the previous year.

The new intravenous immunoglobulin Yimmugo^® had a particularly positive impact, with sales increasing by € 25.5 million to € 41.6 million.

Group EBIT decreased to € 71.1 million in the first nine months of 2024 from € 125.4 million in the same period of 2023. This development is largely due to the contribution from technology disclosure and development services as part of the technology and license agreement with Grifols, S.A. which reduced to € 87.3 million, compared to € 112.3 million.

At € 37.0 million, adjusted EBIT, which reflects operating performance excluding exceptional items, was above the previous year’s level (€ 34.8 million).

The financial result for the first nine months of the current financial year improved to € -26.6 million (previous year: € -29.3 million). This development is mainly due to the € 4.9 million decrease in interest expenses. Tax expenses increased by € 7.0 million to € 14.6 million compared to the previous year.

As a result of the factors described above, earnings after tax (EAT) for the Biotest Group fell to € 29.9 million in the first three quarters of the 2024 financial year, compared to € 88.4 million in the same period of the previous year. This corresponds to earnings per ordinary share of € 0.75, compared with € 2.22 in the same period of the previous year.

Biotest submitted the initial marketing authorization application for its fibrinogen concentrate (BT524) to the Paul-Ehrlich-Institute, following the decentralized procedure for approval in Germany, Austria and Spain. A first marketing authorization is expected for mid-2025.

 

Outlook:

The Board of Management currently expects a revenue increase in the low single-digit percentage range for the 2024 financial year compared to 2023. This includes revenues from technology disclosure and from development services for Grifols, S.A. Previously, an increase in the high single-digit percentage range had been expected. The ongoing conflict in the Middle East poses significant risks to revenue and earnings. Economic instability in the region could lead to decreasing sales figures and may impact our financial performance. Additionally, supply chain disruptions may result in delays and increased costs.

The return on capital employed (ROCE) for the 2024 financial year is to be corrected to the range of 5-8% and the cash flow from operating activities to a negative mid-double-digit million range. Previously, a slightly improved ROCE compared to the 2023 financial year (12.3% as of December 31, 2023) and a positive cash flow from operating activities significantly above the previous year’s level have been expected (€ -2.7 million as of December 31, 2023). Measures to improve the cash flow have already been initiated.

The Board of Management expects an operating result (EBIT) in a range between € 80 million and € 100 million for 2024.

The nine-month report is available on the company’s website under Quarterly Reports (biotest.com).

 

 

About Biotest

Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German Stock Exchange. Since May 2022, Biotest has been a part of the Grifols Group, headquartered in Barcelona, Spain (www.grifols.com).

 

 

IR contact

Dr Monika Baumann (Buttkereit)
Phone: +49-6103-801-4406
Mail: ir@biotest.com

 

PR contact

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

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

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

 

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

Ad hoc NOTICE

Notification pursuant to Art. 17 EU Market Abuse Regulation (MAR)

 

Biotest corrects forecast for revenue, cash flow and ROCE – EBIT guidance unchanged

 

Dreieich, Germany, November 14, 2024. The Board of Management currently expects a revenue increase in the low single-digit percentage range for the 2024 financial year compared to 2023. This includes revenues from technology disclosure and from development services for Grifols, S.A. Previously, an increase in the high single-digit percentage range had been expected.

The return on capital employed (ROCE) for the 2024 financial year is to be corrected to the range of 5-8% and the cash flow from operating activities to a negative mid-double-digit million range. Previously, a slightly improved ROCE compared to the 2023 financial year (12.3% as of December 31, 2023) and a positive cash flow from operating activities significantly above the previous year’s level have been expected
(€ -2.7 million as of December 31, 2023).

The Board of Management continues to expect an operating result (EBIT) in a range between € 80 million and € 100 million for the 2024 financial year.

 

Biotest Aktiengesellschaft
The Board of Management
 

Biotest AG
Landsteinerstr. 5
D-63303 Dreieich

www.biotest.com

 

Disclaimer

This document contains forward-looking statements on the overall economic development and the business, earnings, financial and asset situation of Biotest AG and its subsidiaries. These statements are based on the company’s current plans, estimates, forecasts and expectations and are therefore subject to risks and uncertainties that could cause actual developments to differ materially from those anticipated. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and does not assume any obligation to do so.

 

About Biotest

Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German Stock Exchange. Since May 2022, Biotest has been a part of the Grifols Group, headquartered in Barcelona, Spain (www.grifols.com).

 

IR contact

Dr Monika Baumann (Buttkereit)
Phone: +49-6103-801-4406
Mail: ir@biotest.com

 

PR contact

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

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

 

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

 

 

Contact:

Martin Möller
Chief Financial Officer
Biotest AG
Landsteinerstr. 5
63303 Dreieich
Tel. +40 6103 801 2999
Fax: +49 6103 801 767
martin.moeller@biotest.com

Dermapharm Holding SE posts strong results for Q3 2024,
Arkopharma (France) back above prior-year EBITDA levels for first time

 

• Consolidated revenue up 2.7% to EUR 890.1 million. Growth in high-margin “Branded pharmaceuticals” more than offsets declining revenue in “Other healthcare products” segment.
• Above-average increase in (unadjusted) consolidated EBITDA by 12.3% to EUR 234.1 million, unadjusted EBITDA margin improves by 2.3 percentage points to 26.3%. Adjusted EBITDA of EUR 240.3 million results in adjusted EBITDA margin of 27.0%.
• Taken in isolation, Q3 2024 revenue up 9.5% on prior-year quarter; unadjusted consolidated EBITDA up 22.0% and adjusted consolidated EBITDA up 15.2%. Trend fuelled by branded pharmaceuticals segment in general and improvement at Arkopharma.
• Board of Management confirms outlook for 2024 overall, continues to expect consolidated revenue of EUR 1,170–1,210 million and adjusted EBITDA of EUR 305–315 million.

 

Grünwald, 14 November 2024 – Dermapharm Holding SE (“Dermapharm”), a rapidly growing manufacturer of branded pharmaceuticals and other healthcare products, today publishes its results for the first nine months of 2024.

Dermapharm Holding SE performed in line with expectations in the first nine months of 2024. Consolidated revenue increased by 2.7% to EUR 890.1 million as compared to the prior-year period (prior-year period: EUR 866.6 million). This was due to the strong organic growth in the existing portfolio, which more than offset the decline in revenue at Arkopharma and the projected decrease in revenue from the vaccine business. In addition, the rise in revenue was also bolstered by the revenue from Montavit, which was consolidated from July 2023.

Adjusted for non-recurring effects, EBITDA amounted to EUR 240.3 million, on par with the figure for the prior-year period (EUR 243.8 million); the adjusted EBITDA margin fell by 1.1 percentage point to 27.0%. Wage increases and the inflation-related rise in other operating expenses were thus partially offset by an increase in the gross margin. Adjusted to account for the loss of revenue from vaccines, sustainable EBITDA for the first 9 months of 2024 rose by a considerable 12.4%, with the corresponding EBITDA margin up year on year by 1.4 percentage points. Unadjusted EBITDA increased substantially by 12.3% to EUR 234.1 million (prior-year period: EUR 208.4 million). There were markedly fewer items to adjust for in the first nine months of 2024 than in the same period of the previous year (EUR 6.2 million compared to EUR 35.5 million).

“We are immensely satisfied with the Company’s performance in the first nine months of 2024. We were able to offer further evidence of our M&A expertise by successfully acquiring and integrating Montavit in the wake of its insolvency. I am particularly pleased to report that our internationalisation efforts are gaining pace. We are therefore highly optimistic for the final quarter and confident that we will meet our forecasted targets for 2024”, said Dr Hans-Georg Feldmeier, Chairman of the Board of Management of Dermapharm Holding SE.

 

Branded pharmaceuticals

In the “Branded pharmaceuticals” segment, organic growth in the Group’s core business in Germany and at its international subsidiaries translated to a 9.1% rise in revenue from EUR 395.7 million in the previous year to EUR 431.6 million. Additionally, after having been consolidated for three months in the previous year, starting from July 2023, Montavit made a positive contribution to revenue growth. The projected decline in revenue from the vaccine business, which had last peaked in Q1 2023, was therefore more than offset by the Group’s strong existing business.

Adjusted EBITDA amounted to EUR 197.3 million, representing 45.7% of revenue (prior-year period: EUR 183.8 million, or 46.4%). Unadjusted EBITDA rose by 18.7% to EUR 192.3 million (prior-year period: EUR 162.0 million), resulting in an EBITDA margin of 44.6% (prior-year period: 40.9%).

Other healthcare products

In the “Other healthcare products” segment, Dermapharm generated EUR 271.7 million in revenue in the first nine months of 2024 (prior-year period: EUR 287.9 million). This decline in revenue was attributable primarily to the French company, Arkopharma. The first half of 2023 had seen unusually high sales in the French pharmacies market in the wake of a price hike at the beginning of the year as well as major product launches. Although sales to end customers via pharmacies remained at a high level, pharmacies had been reducing their sizeable inventories since the end of 2023, resulting in lower demand in the first few months of 2024. This trend was amplified by increasingly fierce competition and the associated pressure on prices and volumes. In the third quarter of 2024, Arkopharma increased its revenue to the previous year’s level for the first time, with EBITDA even exceeding the previous year’s figure.

Adjusted EBITDA for the segment amounted to EUR 45.8 million (prior-year period: EUR 63.3 million). This translates to an adjusted EBITDA margin of 16.9% (prior-year period: 22.0%). The decline is due to the effects described above, which resulted in a lower gross margin. However, cost-cutting measures at the beginning of the year made it possible to partially offset this development. Unadjusted EBITDA amounted to EUR 44.6 million (prior-year period: 49.6 million), and the EBITDA margin amounted to 16.4% (prior-year period: 17.2%).

Parallel import business

Revenue in the “Parallel import business” segment rose by 2.2% to EUR 186.9 million (prior-year period: EUR 182.9 million). This increase was attributable primarily to the high availability of products, attractive procurement prices and growing market volume. From an operational standpoint, the decision to increase stockpiles helped to improve product availability to an appropriate level. In addition, efficiency enhancements in production and successful product launches were realised. However, the increase in sales allowances resulting from higher health insurance discounts related to the portfolio eroded these positive effects, with EBITDA remaining at the same level as in the previous year (EUR 1.1 million in the current and prior-year period). Just as in the previous year, the EBITDA margin for the segment was also 0.6% for the first nine months.

Board of Management confirms outlook for 2024 overall

In light of the Company’s projected performance in the first nine months of financial year 2024 and the recently reinforced positive trend at Arkopharma, the Board of Management confirms that both consolidated revenue and adjusted EBITDA will be in line with the published forecast range of between EUR 1,170–1,210 million and EUR 305–315 million, respectively.

The full interim statement for Q3 2024 is available from today at https://ir.dermapharm.de/en.
 

IFRS figures for 9M 2024 and the prior-year period 

(excluding segment reconciliation/Group holding company)¹

EUR million	9M 2024	9M 2023	Change
Consolidated revenue	890.1	866.6	+2.7%
Branded pharmaceuticals	431.6	395.7	+9.1%
Other healthcare products	271.7	287.9	-5.6%
Parallel import business	186.9	182.9	+2.2%
Adjusted consolidated EBITDA*	240.3	243.8	-1.4%
Branded pharmaceuticals	197.3	183.8	+7.3%
Other healthcare products	45.8	63.3	-27.6%
Parallel import business	1.1	1.1	0.0%
Adjusted EBITDA margin* (%)	27.0	28.1	-1.1 pp
Branded pharmaceuticals	45.7	46.4	-0.7 pp
Other healthcare products	16.9	22.0	-5.1 pp
Parallel import business	0.6	0.6	0.0 pp
Consolidated EBITDA	234.1	208.4	+12.3%
Branded pharmaceuticals	192.3	162.0	+18.7%
Other healthcare products	44.6	49.6	-10.1%
Parallel import business	1.1	1.1	0.0%
EBITDA margin (%)	26.3	24.0	+2.3 pp
Branded pharmaceuticals	44.6	40.9	+3.7 pp
Other healthcare products	16.4	17.2	-0.8 pp
Parallel import business	0.6	0.6	0.0 pp

*9M 2024 EBITDA was adjusted for non-recurring items amounting to EUR 6.2 million.
  9M 2023 EBITDA was adjusted for non-recurring items amounting to EUR 35.5 million.

 

Company profile

Dermapharm – Pharmaceutical Excellence “Made in Europe”

Dermapharm is an innovative and rapidly growing manufacturer of branded pharmaceuticals and other healthcare products. Founded in 1991, the Company is based in Grünwald near Munich. In addition to its main location in Brehna near Leipzig, Dermapharm also operates other production, development and distribution locations in Germany, the rest of Europe and the United States.

In the “Branded pharmaceuticals” segment, Dermapharm has more than 1,300 marketing authorisations with more than 390 active pharmaceutical ingredients. Dermapharm’s portfolio of pharmaceuticals is tailored to selected therapeutic areas in which the Company is a market leader, especially in Germany. The Company’s integrated business model extends from in-house product development and production through quality management and logistics to the distribution of branded pharmaceuticals by a trained pharmaceutical sales force.

Dermapharm bundles food supplements, herbal pharmaceuticals, cosmetics, medical devices, herbal extracts and medicinal cannabis in its “Other healthcare products” segment. In this segment, Dermapharm can tap the expertise of Arkopharma, the market leader for herbal food supplements in France, and the Spanish company Euromed S.A., a leading global manufacturer of herbal extracts and plant-based active ingredients for the pharmaceuticals, nutraceuticals, foodstuffs and cosmetics industries.

Dermapharm also operates the “Parallel import business” segment under the axicorp brand. axicorp imports originator pharmaceuticals from other EU Member States and resells them to pharmaceuticals wholesalers and pharmacies in Germany. This enables axicorp to benefit from the different pricing structures in the individual EU member states. Based on revenue, axicorp is currently the sixth largest parallel importer in Germany.

With a consistent R&D strategy and numerous successful product and company acquisitions and by stepping up its internationalisation efforts, the Group is continuously optimising its business activities and seeks external growth opportunities in addition to organic growth.

 

Contact

Investor Relations & Corporate Communications
Britta Hamberger
Tel.: +49 (0)89 – 64186-233
E-mail: ir@dermapharm.com

 

 

[1] Due to rounding differences, the figures presented for the segments may not entirely match the reported totals.

PharmaSGP with strong revenues growth in 9M 2024 – revenues forecast for FY 2024 raised 

Gräfelfing, November 14, 2024 – In the third quarter of 2024, the German OTC pharmaceutical company PharmaSGP Holding SE was able to continue the dynamic business development of the first half of the year, generating revenues of €88.6 million in the first nine months of 2024 based on preliminary, unaudited figures. This represents an increase of 17.0% over the same period of the previous year (€75.7 million). The high-performance level of the already strong quarters of the first half of the year was confirmed in Q3 2024 with revenues of €30.2 million. With an increase of 9.4% compared to the previous year, adjusted earnings before interest, taxes, depreciation and amortization (adjusted EBITDA) amounted to €27.0 million in the first nine months of 2024. Consequently, the adjusted EBITDA margin reached 30.5%.

CEO Natalie Weigand comments: “I am very pleased that we were able to build on the positive business development of the first half of the year in the third quarter despite a still difficult macroeconomic and geopolitical environment. This impressive growth trajectory underlines the effectiveness of our platform and the measures we have taken as part of our marketing strategy. Thanks to these measures, we have been able to launch new products on the market very successfully so far this year.”

CFO Michael Rudolf adds: “Both in terms of revenues and earnings, PharmaSGP has performed very well in the first nine months of the year. In particular, revenues growth has been dynamic, prompting us to raise our revenues guidance for the full year. Based on our strong structural and financial base, we are also very positive beyond the 2024 financial year and expect the company’s successful development to continue.”

In light of the positive business development in the first nine months of the year, the Management Board of PharmaSGP has raised its revenues forecast and now expects revenues for fiscal year 2024 to be in the range of €112.0 million to €117.0 million (previous forecast: €107.0 million to €112.0 million). With regard to adjusted EBITDA, the Management Board continues to expect a figure between €35.0 million and €38.0 million. This corresponds to an adjusted EBITDA margin of 31.3% to 32.5%.

PharmaSGP will publish its full nine-months report 2024 on November 28, 2024.

 

OVERVIEW OF PRELIMINARY YEAR-ON-YEAR FIGURES

Consolidated figures (in € million)	9M 2024		9M 2023	∆
Revenues	88.6		75.7	+17.0%
Adjusted EBITDA	27.0		24.7	+9.4%
Unadjusted EBITDA	26.9		24.8	+8.7%
Adjusted EBITDA margin	30.5%		32.7%
Unadjusted EBITDA margin	30.4%		32.7%
Revenues by region (in € million)	9M 2024		9M 2023	∆
Germany	59.8		55.6	+7.5%
Italy	17.2		9.5	+81.0%
Austria	9.2		7.6	+20.6%
Other European countries	2.4		3.0	-18.3%
Revenues share by region	9M 2024		9M 2023
Germany	67%		73%
Italy	19%		13%
Austria	10%		10%
Other European countries	4%		4%
Revenues by product category (in € million)		9M 2024	9M 2023	∆
Health Brands	85.6		72.7	+17.7%
Beauty Brands	2.9		2.9	-0.7%

CONTACT

cometis AG
Jakob Hafer
Phone: +49-611-20585522
Email: ir@pharmasgp.com

 

ABOUT PHARMASGP HOLDING SE

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

The Company’s core brands cover chronic indications, including rheumatic pain, nerve pain and other age-related ailments. In Germany, PharmaSGP is the market leader for systemic chemical-free pain remedies with its brand families RubaXX® for rheumatic pain and Restaxil® for neuralgic pain. Furthermore, PharmaSGP also offers leading products against sexual weakness and vertigo symptoms. Since introducing the first product from the current product portfolio in 2012, PharmaSGP has successfully established its business model in other European countries, including Austria, Italy, Belgium, Spain and France. In September 2021, the product portfolio was expanded by the brands Baldriparan®, Formigran®, Spalt® and Kamol®, thus also strengthening or developing the indications pain and sleep disorder. The sales territory was expanded to include Switzerland and Eastern Europe. In 2023, PharmaSGP generated revenues of €101.1 million at an adjusted EBITDA margin of 33.7%. 

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

Berlin, November 14, 2024. Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) increased its sales by 17% year-on-year to € 215.5 million in the first nine months of 2024. Recurring EBIT from continuing operations (adjusted EBIT) rose by 24% to € 46.7 million. Net income (from continuing and discontinued operations) grew by 15% and reached € 23.4 million or € 1.12 per share.

The Medical segment recorded sales of € 104.5 million in the first nine months of the year, around € 21.7 million or 26% higher than in the previous year. The main growth driver remains the pharmaceutical radioisotope business, while all other main product groups also increased compared to the previous year.

The Isotope Products segment generated sales of € 111.0 million, an increase of € 10.0 million or 10% compared to the first nine months of 2023. In comparison to the same period of the previous year, seasonal effects and shifts between product groups continued to move towards higher-margin products.

For the 2024 financial year, the Executive Board continues to expect revenues of around € 265 million and an EBIT (earnings before interest and taxes) before special items from continuing operations of around € 55 million.

The complete quarterly report can be viewed here: https://www.ezag.com/q32024en/

About Eckert & Ziegler.
Eckert & Ziegler SE with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

Your contact:
Eckert & Ziegler SE, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-138, karolin.riehle@ezag.de, www.ezag.com 

 

Abivax Announces Former Prometheus COO, Mark Stenhouse, Appointed as Board Observer & Advisor to Abivax

PARIS, France, November 13, 2024, 10:00 pm CET – Abivax SA (Euronext Paris and Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced the appointment of Mark Stenhouse as Board Observer and Advisor to Abivax.

Mr. Stenhouse brings more than 30 years of experience in the biopharma industry. Most recently, he served as Chief Operating Officer of Prometheus Biosciences, a biotechnology company focused on gastrointestinal diseases that was acquired by Merck for $10.8 billion in 2023. Prior to Prometheus, Mr. Stenhouse spent over 25 years at AbbVie, most recently serving as Vice President of U.S. Immunology. In this capacity, Mr. Stenhouse oversaw U.S. sales and marketing teams for HUMIRA®.

In addition to his positions at Prometheus and Abbvie, Mr. Stenhouse held an executive leadership role at Exact Sciences. He holds a Bachelor of Science in Business Administration from the College of Charleston.

Marc de Garidel, Chief Executive Officer of Abivax, said: “We are pleased to welcome Mark to the role of Board Observer and Advisor to Abivax. We expect his perspective and extensive experience in gastroenterology and immunology to undoubtedly support our continued progress as we head toward commercialization of obefazimod and strengthen our pipeline.” 

Mark Stenhouse, Board Observer & Advisor to Abivax, said: “I am impressed with the clinical profile of obefazimod and its potential to address unmet needs in the patient community. I look forward to working alongside the Abivax management team and Board of Directors as the company continues to advance toward key milestones.”

About Obefazimod

Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to potentially enhance the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with ulcerative colitis (UC) have generated positive data, resulting in the initiation of a pivotal global Phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. A Phase 2b clinical trial in Crohn’s disease is ongoing, with the first patient enrolled in October 2024, and exploration of potential combination therapy opportunities in UC is ongoing.

About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @Abivax.

Contact:

Patrick Malloy
SVP, Investor Relations, Abivax
patrick.malloy@abivax.com
+1 847 987 4878

DISCLAIMER

This press release contains forward-looking statements, including those relating to the Company’s business objectives. Words such as “continue,” “expect,” “forward,” “potential” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax’s drug candidates and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. 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 universal registration document (Document d’Enregistrement Universel) and in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. Current results are not necessarily indicative of future results. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. 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. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. 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. 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 judgment. 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.

“Abivax” and the Abivax logo and other trademarks or service marks of Abivax SA in this press release are the property of Abivax SA. All other trademarks, trade names and service marks appearing in this press release are the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.

 Immunic Announces Publication of Data From Phase 1/1b  
Clinical Trial of IMU-856 in the Peer Reviewed Journal,  
The Lancet Gastroenterology & Hepatology

 – Includes Phase 1 Data in Healthy Human Subjects and
Phase 1b Data in Celiac Disease Patients –

NEW YORK, November 13, 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 the data from its phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), has been published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology. Lead authored by Dr. A. James Daveson, Gastroenterologist, Wesley Research Institute and Coral Sea Clinical Research Institute, Queensland, Australia, the paper is entitled, “Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in coeliac disease: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial.” It can be accessed through the following link: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(24)00248-6/fulltext.

Dr. Daveson stated, “Celiac disease affects approximately 1.4% of the world’s population. The only current treatment option is a strict, lifelong gluten-free diet, which poses significant challenges due to dietary and social restrictions and the risk of cross-contamination, which leads to persistent intestinal inflammation with villous atrophy in many patients. IMU-856’s potential ability to improve the integrity and function of the intestinal barrier represents a promising, novel approach to treat this condition. Importantly, this phase 1b clinical trial is the first study to show that IMU-856 can mitigate the gluten-related effects in celiac disease patients. Based on this result, in conjunction with the drug’s favorable safety and tolerability profile, we have concluded that it warrants further clinical investigation.”

“The publication of our phase 1/1b clinical data in healthy human subjects and patients with celiac disease, in such a prestigious peer reviewed journal, confirms that IMU-856’s novel mechanism modulating SIRT6, a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, can represent an entirely new approach to treating gastrointestinal diseases,” added Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “In our phase 1b clinical trial, IMU-856 showed the first clinical signals of its potential ability to restore a healthy gut by renewal of the gut wall, demonstrating meaningful improvements over placebo in four key dimensions of celiac disease pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. Together with a favorable safety and tolerability profile, it may set the stage for a potential first-in-class, oral celiac disease therapy. Additionally, we believe that this data provides initial clinical proof-of-concept for a potentially new, oral therapeutic approach to a range of gastrointestinal diseases with high unmet needs, beyond celiac disease.”

The first two portions of the phase 1 clinical trial, Parts A and B, were single ascending dose and multiple ascending dose, double-blind, placebo-controlled studies in a total of 71 healthy human subjects. Single and multiple ascending doses of IMU-856 were found to be safe and well-tolerated, with no investigational medicinal product (IMP)-related serious or severe treatment-emergent adverse events. No maximum tolerated dose was reached in either part.

Part C was structured as a double-blind, randomized, placebo-controlled trial, designed to assess the safety and tolerability of IMU-856 in patients with celiac disease during periods of gluten-free diet and a 15-day gluten challenge with 6 g of gluten given daily. Further objectives included pharmacokinetics and initial clinical activity assessments, including malabsorption parameters, biomarkers for enterocyte functional mass, such as citrulline, disease-related symptoms as well as histological changes. The trial was conducted at sites in Australia and New Zealand. A total of 43 patients were enrolled in two consecutive cohorts with 80 mg or 160 mg of IMU-856 or placebo given once-daily over 28 days. The data demonstrated positive effects for IMU-856 over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients’ symptoms, biomarker response, and enhancement of nutrient absorption. IMU-856 was also observed to be safe and well-tolerated in this trial. There were no IMP-related serious or severe treatment-emergent adverse events, nor was there any dose-dependency in adverse events. Moreover, the rates of treatment-emergent adverse events in non-disease-related parameters were comparable between the active treatment groups and placebo.

About IMU-856

IMU-856 is an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Based on preclinical data, the compound may represent a unique treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from gastrointestinal diseases such as celiac disease, inflammatory bowel disease and other intestinal barrier function associated diseases. Based on preclinical investigations demonstrating no suppression of immune cells, IMU-856 may have the potential to maintain immune surveillance for patients during therapy, which would be an important advantage versus immunosuppressive medications. IMU-856 demonstrated positive results in a phase 1b clinical trial in celiac disease patients in four key dimensions of the disease’s pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. Currently, the company is preparing for phase 2 clinical testing. IMU-856 is an investigational drug product that has not been approved in any jurisdiction.

 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 Immunic’s development programs and the targeted diseases; the potential for IMU-856 to safely and effectively target diseases; preclinical and clinical data for IMU-856; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. 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. 
Jessica Breu 
Vice President Investor Relations and Communications
+49 89 2080 477 09 
jessica.breu@imux.com 

US IR Contact 
Rx Communications Group 
Paula Schwartz 
+1 917 633 7790 
immunic@rxir.com 

US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com