CHEPLAPHARM CLOSES FINANCIAL YEAR 2023 WITH RECORD REVENUE AND DOUBLE-DIGIT GROWTH

Greifswald, 26^th April 2024

• Double-digit revenue growth again: +17% YoY to € 1,498.4 million (FY2022: € 1,279.5 million)
• EBITDA increases significantly by +14% YoY to € 780.5 million (FY2022: € 685.7 million)
• EBITDA margin remains at a high and industry-leading level of 52% (FY2022: 54%)
• New affiliates in Japan and Switzerland drive transformation into an international group of companies
• Number of employees grows to 666, an increase of 24% (FY2022: 535)

 

The CHEPLAPHARM Group, a global leader in the acquisition of originator products from the research-based pharmaceutical industry, closed the financial year 2023 with a record revenue of € 1,498.4 million. The company, headquartered in Greifswald/Germany, is continuing its dynamic and profitable double-digit percentage growth track. In addition to the revenue record, the opening of the affiliates in Japan and Switzerland are important milestones in the transformation to an international group of companies. The largest transaction in the company’s history, the acquisition of the Zyprexa^® portfolio from Eli Lilly for a purchase price of around € 1.3 billion, rounds off the successful financial year 2023.

 

The annual financial statements for the financial year 2023 published today show a year-over-year increase in revenue of +17% to € 1,498.4 million (FY2022: € 1,279.5 million). EBITDA totalled € 780.5 million in the reporting period, an increase of +14% compared to the financial year 2022 (FY2020: € 685.7 million). At 52%, the EBITDA margin remained at a high and industry-leading level in 2023. CHEPLAPHARM is thus continuing its dynamic and profitable growth track over the last years in 2023 as well and significantly exceeding the targets it has set itself.
The strong growth in revenue and earnings was driven by the successful acquisitions in 2023, with the largest transaction in the company’s history making a particularly significant contribution to growth. In July 2023, CHEPLAPHARM acquired the Zyprexa^® portfolio from Eli Lilly for around € 1.3 billion. Further acquisitions of products from Roche (Xeloda^® – China and Japan), AstraZeneca (Pulmicort Flexhaler^® – USA) and Teva (Myocet^® – Europe) also had a positive impact on revenue development and the further diversification of the portfolio. In total, CHEPLAPHARM invested around € 1.8 billion in acquisitions of established branded products in 2023, a record level of investment.

“We look back on an extremely successful year 2023 and continued to grow profitably in a challenging market environment. In addition to this dynamic growth, we have also consistently driven forward our transformation into an international group of companies. Within just a few months, we have established two fully operational affiliates in Japan and Switzerland with over 30 new colleagues,” says Edeltraud Lafer, CEO of CHEPLAPHARM, summarising the positive results.

With the two subsidiaries in two globally important pharmaceutical markets, CHEPLAPHARM is expanding and strengthening its global presence. The new locations will enable economies of scale to be realised and profitability to be further increased.

“In the financial year 2023, we were also very successful on the capital market and raised more than one billion euros with two bonds,” adds Dr Kia Parssanedjad, CFO of CHEPLAPHARM. “This enabled us to finance the acquisition of the Zyprexa^® portfolio and further strengthen our liquidity position. The two successful placements demonstrate investors’ great confidence in the strength and resilience of our business model and give us the flexibility to further invest in attractive branded medicines in the current financial year 2024 and thus continue our growth track.”

As a profitable and steadily growing company, CHEPLAPHARM is an attractive employer. The number of employees rose by 131 to 666 at the end of the year, an increase of 24% compared to the previous year. The majority of the new colleagues started work at the headquarters in Greifswald. This means that CHEPLAPHARM remains one of the most important employers in the region.

 

 

About CHEPLAPHARM
CHEPLAPHARM is a family-owned company with headquarters in Greifswald. For over 20 years, the company has been very successful in taking over well-known and well-established medicines from the research-based pharmaceutical industry and transferring them to an existing global network of partners for production and distribution. In this way, CHEPLAPHARM ensures the continuous supply of these medicines to patients worldwide. In addition to its headquarters in Greifswald, CHEPLAPHARM operates further sites in France, Japan, Russia and Switzerland. The company employs around 700 people worldwide.

Please refer to www.cheplapharm.com for additional information.

Press office:
CHEPLAPHARM ǀ Ziegelhof 24 ǀ 17489 Greifswald ǀ press(at)cheplapharm.com

 

Publication of inside information pursuant to Article 17 of Regulation (EU) No 596/2014

 

M1 Kliniken AG decides to start share buyback

Berlin, 26.04.2024 – The Management Board of M1 Kliniken AG today resolved to repurchase up to 1,000,000 shares of the Company in a maximum total volume of EUR 12,600,000.00 (excluding incidental acquisition costs). The resolution is based on the authorization of the Annual General Meeting of 9 July 2020 to acquire own shares. The buyback program is to start on 29 April 2024 and to be completed by the end of 25 April 2025 at the latest. The share buyback and the purchase settlement will be carried out exclusively by a credit institution or an investment firm, which will decide on the timing of the acquisition of shares independently of and without influence by the Company. The sole purpose of the share buyback program is to use the repurchased shares for all purposes provided for in the authorization resolution of the Company’s Annual General Meeting of 9 July 2020 and for all other purposes permitted by the Company’s share law.

The buy-back program and its implementation shall take place in compliance with the requirements of the safe harbor regulations pursuant to Art. 5 para. 2 of the Market Abuse Regulation (EU) No. 596/2014 and Art. 2, 3 and 4 of the Delegated Regulation (EU) No. 2016/1052, with the exception of the purpose of the buy-back. This is broader than determined by Art. 5 (2) of the Market Abuse Regulation.

 

 

About M1 Kliniken AG

M1 Kliniken AG is the leading fully integrated provider of aesthetic medical healthcare services in Europe. The Group offers products and services of the highest quality standards in the aesthetic and surgical fields. Beauty medical treatments are currently offered at 61 specialist centres under the “M1 Med Beauty” brand. With six operating theatres and 35 beds, the “M1 Schlossklinik” for Plastic and Aesthetic Surgery in Berlin is one of the largest and most modern facilities of its kind in Europe. M1 Kliniken has been driving forward its internationalisation since the end of 2018 and is currently represented in ten countries.

Contact:
Patrick Brenske, Management Board
Corporate Communications
E-Mail: ir@m1-kliniken.de

STRATEC POSTS RESULTS FOR FIRST QUARTER OF 2024

• Subdued start to financial year as expected, but noticeable revival apparent in market and very strong sales growth expected for second quarter of 2024
• Consolidated sales Q1/2024 -15.7% at constant currency to € 50.9 million (Q1/2023: € 60.5 million)
• Efficiency measures and structural changes taking effect: Despite negative scale effects, adjusted EBIT margin of 6.2% in Q1/2024 almost at previous year’s level (Q1/2023: 6.3%)
• 2024 guidance confirmed: Sales on a constant-currency basis expected to remain stable or grow slightly with adjusted EBIT margin of around 10.0% to 12.0%
• Well-filled development pipeline and major advances in development cooperations

Birkenfeld, April 26, 2024

STRATEC SE, Birkenfeld, Germany, (Frankfurt: SBS; Prime Standard, SDAX) today announced its financial results and major events for the period from January 1, 2024 to March 31, 2024 with the publication of its Quarterly Statement Q1|2024.

KEY FIGURES ¹

€ 000s	Q1/2024	Q1/2023	Change
Sales	50,871	60,478	-15.9% (cc: -15.7%)
Adj. EBITDA	6,845	7,292	-6.1%
Adj. EBITDA margin (%)	13.5	12.1	+140 bps
Adj. EBIT	3,145	3,816	-17.6%
Adj. EBIT margin (%)	6.2	6.3	-10 bps
Adj. consolidated net income	1,226	2,133	-42.5%
Adj. earnings per share (€)	0.10	0.18	-44.4%
Earnings per share (€)	0.04	0.11	-63.6%

Adj. = adjusted
bps = basis points
cc = at constant currency

¹ To facilitate comparison, figures have been adjusted to exclude amortization resulting from purchase price allocations in the context of acquisitions and other non-recurring items (including advisory expenses relating to M&A activities).

BUSINESS PERFORMANCE
Consolidated sales at the STRATEC Group amounted to € 50.9 million in the first quarter of 2024 (Q1/2023: € 60.5 million). On a constant-currency basis, this corresponds to a reduction of 15.7% (nominal: -15.9%). Natech Group, which was first consolidated as of July 1, 2023, contributed 470 basis points to sales. Overall, developments in the first quarter of 2024 were generally consistent with the company’s original expectations. As expected, the first quarter was affected by ongoing high volumes of stocks at customers and subdued market demand for molecular diagnostic systems at present due to the downstream effects of the COVID-19 pandemic. Given the specific timing of sales recognition for development services, STRATEC also reported significantly lower sales with Development and Services. By contrast, sales with Service Parts and Consumables rose significantly, with this being due to the significant expansion of the installed systems base in recent years and rising utilization levels among end customers.

Adjusted EBIT stood at € 3.1 million in the first quarter of 2024, compared with € 3.8 million in the previous year’s quarter. As a result, the adjusted EBIT margin amounted to 6.2% and, despite significant negative scale effects, almost matched the previous year’s figure (Q1/2023: 6.3%). This key figure benefited in particular from measures implemented in the earnings improvement program launched in 2023, as well as from an improved sales mix, with a high share of Service Parts and Consumables.

As a result of the reduction in operating earnings and higher financing expenses, adjusted consolidated net income for the first quarter of 2024 decreased to € 1.2 million, as against € 2.1 million in the previous year. Adjusted earnings (basic) came to € 0.10 (Q1/2023: € 0.18).

To facilitate comparison, the earnings figures have been adjusted to exclude amortization resulting from purchase price allocations in the context of acquisitions and other non-recurring items (including advisory expenses relating to M&A activities). A reconciliation of the adjusted figures with those reported in the consolidated statement of comprehensive income can be found in the Quarterly Statement Q1|2024 also published today.

FINANCIAL GUIDANCE
The significant revival in business from the second quarter assumed in the financial guidance for the 2024 financial year has recently been underpinned by customers confirming order volumes. Furthermore, due to progress made with development projects STRATEC expects significant growth in the volume of sales recognized for development services in the second quarter of 2024. STRATEC’s Board of Management is therefore forecasting very strong year-on-year sales growth for the second quarter of 2024. In view of this and given that developments in the first quarter were consistent with expectations, STRATEC can confirm its financial guidance for 2024. Overall, STRATEC therefore still expects its consolidated sales on a constant-currency basis to remain stable in 2024 or show slight growth compared with the previous year. The adjusted EBIT margin is still forecast at around 10.0% to 12.0% (previous year: 10.3%).

Due to diverse downstream effects of the pandemic, customers’ order behavior continues to be marked by increased volatility. As a result, STRATEC’s planning for 2024 is subject to greater uncertainties than usual. These also relate to the potential development in the product mix, the degree to which systems in the market are utilized, and the impact of further measures to enhance efficiency and make structural adjustments to the supply chain that are planned but not yet accounted for in the forecast. Based on current figures and depending on actual capacity utilization rates, which are currently rising, potential earnings improvements in a low single-digit million euro range have already been identified.

For the 2024 financial year, STRATEC has planned investments in property, plant and equipment and in intangible assets corresponding to a total of 6.0% to 8.0% of sales (2023: 6.7%).

PROJECTS AND OTHER DEVELOPMENTS
In the first quarter of 2024, STRATEC pressed ahead once again with numerous developments and projects and concluded new agreements for new cooperations. Major advances were made with a development project in the field of immunohematology, for example, with an extension in the development cooperation agreed. Given the well-stocked development pipeline, which contains numerous projects in various stages of development, STRATEC expects to see major market launches in the coming months and years as well.

DEVELOPMENT IN PERSONNEL
Including personnel hired from temporary employment agencies and trainees, the STRATEC Group had a total of 1,473 employees at the end of the first quarter of 2024 (previous year: 1,502). Excluding employees at Natech Group, which was first consolidated as of July 1, 2023, the number of employees therefore showed an organic decrease of 7.9%. This reduction is to be viewed in connection with the efficiency enhancement program initiated in 2023.

QUARTERLY STATEMENT Q1|2024
The Quarterly Statement Q1|2024 of STRATEC SE has been published on the company’s website at www.stratec.com/financial_reports.

FORTHCOMING DATES
The Annual General Meeting of STRATEC SE will be held as a virtual AGM on May 17, 2024. The Half-year Financial Report H1|2024 will be published on August 9, 2024.

CONFERENCE CALL AND AUDIO WEBCAST
To mark the publication of the results for the first quarter of 2024, STRATEC will be holding a conference call in English at 2.00 p.m. (CEST) today, Friday, April 26, 2024.

You will receive the dial-in data (telephone number, password + individual PIN) following brief registration at the following link: www.stratec.com/registration

The conference call will also be available at the same time as an audio webcast at http://www.stratec.com/audiowebcast20240426 (brief registration required). Please note that no questions can be submitted via the audio webcast. Clicking this link also enables you to follow or download the slide presentation.

ABOUT STRATEC
STRATEC SE (www.stratec.com) designs and manufactures fully automated analyzer systems for its partners in the fields of clinical diagnostics and life sciences. Furthermore, the company offers complex consumables for diagnostic and medical applications. For its analyzer systems and consumables, STRATEC covers the entire value chain – from development to design and production through to quality assurance.

The partners market the systems, software and consumables, in general together with their own reagents, as system solutions to laboratories, blood banks and research institutes around the world. STRATEC develops its products on the basis of patented technologies.

Shares in the company (ISIN: DE000STRA555) are traded in the Prime Standard segment of the Frankfurt Stock Exchange and are listed in the SDAX select index of the German Stock Exchange.

FURTHER INFORMATION IS AVAILABLE FROM:
STRATEC SE
Jan Keppeler | Investor Relations, Sustainability & Corporate Communications
Tel: +49 7082 7916-6515
ir@stratec.com
www.stratec.com

News Source: Kinarus Therapeutics Holding AG

Mainz Biomed Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm for Integration into Pivotal FDA PMA Clinical Trial for Next Generation Colorectal Cancer Diagnostic

• Groundbreaking topline results demonstrated sensitivity for colorectal cancer of 92% with specificity of 90% and best-in-class sensitivity for advanced adenoma of 82%
   
• 690 subjects analyzed including previously unexamined and reported patients from Company’s ColoFuture and eAArly DETECT studies utilizing the mRNA biomarkers, FIT test, and a proprietary AI Algorithm
   
• The power to determine advanced adenoma, lesions in a pre-cancerous stage, can change the entire CRC diagnostic field, by treating the patient before the polyps can progress to cancer

BERKELEY, US – MAINZ, Germany – April 25, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today groundbreaking topline results from a pooled clinical study which included new patients and subjects from Mainz Biomed’s ColoFuture (Europe) and eAArly DETECT (U.S.) clinical trials evaluating the potential to integrate its portfolio of proprietary novel gene expression (mRNA) biomarkers into a next generation version of the Company’s colorectal cancer (CRC) screening tool. The topline results confirm the positive efficacy results previously reported with a sensitivity for colorectal cancer of 92% with a specificity of 90% and a sensitivity for advanced adenoma of 82%, which is best-in-class and compare favorably to existing commercial products.

“We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.  The new data read-out demonstrates that our next generation product candidate for early-stage CRC detection utilizing mRNA biomarkers, a FIT test and a proprietary AI algorithm has consistently delivered high sensitivity and specificity for both advanced adenomas and colorectal cancer,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “This strong performance is particularly noteworthy as the pooling a significantly higher number of patients, namely two entirely separate patient cohorts from two continents as well as previously unexamined patient samples.  Hence these results represent a critical milestone on our path to launching our FDA PMA pivotal study ReconAAsense, which is planned to recruit up to 15,000 patients. ”

The pooled results include 690 evaluable subjects across 21 sites in the U.S. and 9 sites in Europe. The two cohorts included patients (US cohort aged 45 and older and European cohort aged 40 and older) that provided a stool sample before undergoing a colonoscopy to either screen for CRC (average risk), to follow up on a positive non-invasive test, imaging or symptoms, or if a subject was already identified as having colorectal cancer but before any treatment had been administered. Following colonoscopy and any applicable histopathology, subjects were classified into groups: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT.

The Company plans to publish results of this study at a major medical conference during the second quarter of 2024.

According to the Centers for Disease Control and Prevention (CDC), colorectal cancer is the second most lethal cancer in the U.S. and Europe, but also the most preventable, with early detection providing survival rates above 90%. Mainz Biomed’s proprietary portfolio of mRNA biomarkers has previously demonstrated the ability to detect CRC lesions, including advanced adenomas, a type of pre-cancerous polyp often attributed to this deadly disease . The power to determine lesions in a pre-cancerous stage can change the entire CRC diagnostic field, by treating the patient before the polyps can progress to a cancerous stage. This is especially remarkable as recent studies reveal that blood tests, despite their perceived convenience, lack the sensitivity to detect pre-cancerous conditions effectively. In the landscape of early colon cancer diagnostics with non-invasive tests, stool-based screening methods proved to be the most precise. Subject to a positive outcome of the FDA PMA study, Mainz Biomed’s innovative next generation test has the potential to disrupt the at-home CRC diagnostic screening market by providing the most robust and accurate test and become new gold standard.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information.

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About ColoAlert®

ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018, Franck et al. 2024). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

About Colorectal Cancer

Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.

About Mainz Biomed N.V.  

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is planning to run a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test. To learn more, visit mainzbiomed.com.   

For media inquiries

In Europe:
MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu  

In the U.S.:
Blueprint Life Science Group
Hershel Berry
+1 415 505 3749
hberry@bplifescience.com  

For investor inquiries, please contact info@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

The Federal Ministry for Economic Affairs and Climate Protection (BMWK) is funding a Hanf Farm project in the field of industrial bio-economy with 1.6 million euros. The official funding decision has now been handed over to Managing Director Rafael Dulon and Project Manager Michael Bieder by State Secretary Stefan Wenzel at the Hanover Trade Fair. Wenzel recognised the importance of research and development in the field of bio-economy when handing over the decision. Hanf Farm GmbH is a company of the German industrial hemp and cannabis group SYNBIOTIC SE.

The funding serves to advance the planning and implementation of automated and AI-supported production for processing biogenic raw materials, including hemp, miscanthus and crops from the agricultural use of peatland sites. The project and the funding from the BMWK mark a significant breakthrough in the sustainable production and development of the industrial bio-economy.

Rafael Dulon, Managing Director of Hanf Farm: “We are very grateful for the financial support from the BMWK. The funding enables us to realise our vision of sustainable and efficient production of organic raw materials and to make an important contribution to the development of the industrial bio-economy.”

Michael Bieder, Project Manager Hanf Farm: “The project is a milestone in the field of industrial bio-economy. For the first time, the BMWK is funding the planning and implementation of a fully automated and AI-supported factory for industrial hemp and lignocellulosic fibre raw materials. This innovative approach not only promises to increase efficiency and sustainability in production, but also paves the way for future developments in this area.”

Hanf Farm GmbH is a leading company in the field of sustainable organic raw material production and sees the funding from the BMWK as confirmation of its efforts to create a future-orientated and environmentally conscious economy.

The photo shows from left to right Claudia van Veen (moderator), Michael Bieder (Project Manager Hanf Farm), Rafael Dulon (Managing Director Hanf Farm) and State Secretary Stefan Wenzel (BMWK).

About Hanf Farm
Hanf Farm GmbH specialises in the cultivation, processing and global marketing of high-quality hemp products. The aim is to establish hemp as a cultivated plant in Germany and Europe and to integrate it into agricultural cycles. Hanf Farm GmbH attaches great importance to producing innovative and sustainably valuable products and to taking equal account of ecological, social and economic aspects. Hanf Farm GmbH is a company of the industrial hemp and cannabis group SYNBIOTIC SE.

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 company are research and development, production and commercialisation of hemp, CBD and cannabis products. SYNBIOTIC has a clear strategy to further expand along the value chains of its business areas – hemp and CBD, medical cannabis and consumer cannabis.

Publisher
Hanf Farm GmbH
Rafael Dulon | Managing Director
Dorfstraße 58
17209 Melz
Germany

Media contact Hanf Farm
Michael Bieder
Landline +49 39923 714758
E-mail michael.bieder@hanffarm.de
Internet www.hanffarm.de

Media contact SYNBIOTIC
Rüdiger Tillmann
SYNBIOTIC
Public Relations Manager
E-mail ruediger.tillmann@synbiotic.com
Mobile +49 171 3677028
c/o JOLE.group

Asklepios Group: Asklepios shows resilience in 2023 financial year

• Revenue at EUR 5,452.3 million
• Number of patients treated rises 2.4% to 3.5 million
• Number of FTEs grows thanks to effective strategies to counter the shortage of qualified staff

Hamburg, 25 April 2024. Despite the challenges arising from persistent inflation and structural uncertainties in the healthcare sector, Asklepios Kliniken GmbH & Co. KGaA closed the 2023 financial year with sound results and demonstrated its economic resilience. The upcoming hospital reform will bring major challenges for the healthcare sector. As a strong hospital group with a stable shareholder structure, Asklepios considers itself well positioned in structural terms for the tasks that lie ahead.

The 2023 financial year was influenced by a challenging regulatory environment, general cost inflation and price increases triggered by the ongoing war in Ukraine. Higher staff costs also had an impact on earnings. In this context, the Management Board is happy to be able to report a stable year-on-year development and to have kept consolidated net income at the previous year’s level.

The Asklepios Group treated approximately 3.5 million patients at its 164 healthcare facilities in the 2023 financial year. Despite structural uncertainties in the healthcare sector, Asklepios thus achieved a slight increase in comparison to the previous year (2022: 3.4 million patients). The number of full-time equivalents changed from 49,103 in the previous year to 49,425 on average in 2023. This reflects how Asklepios’ commitment to recruiting specialists on the international labour market as well has paid off. Investments from its own funds amounted to EUR 229.6 million (2022: EUR 218.3 million).

Joachim Gemmel, CEO of Asklepios, explains: “Our mission at Asklepios is to guarantee the best medical care. Sustainable investments in our hospitals are essential here, as our patients’ needs are always at the heart of what we do. That’s why we bring state-of-the-art medicine to where it is needed – whether in the city or in rural areas.”

Marco Walker, CEO of Asklepios, adds: “In view of a demanding market environment, we also see a challenge as an opportunity for progress. We are deliberately taking new approaches and have a clear strategy for continuously optimising healthcare. Our considerations here are particularly focused on digitalisation.”

Revenue amounted to EUR 5,452.3 million in the 2023 financial year (2022: EUR 5,290.0 million). The absolute cost of materials rose by EUR 54.8 million to EUR 1,339.0 million (2022: EUR 1,284.2 million), representing an increase of 4.3% on the previous year’s figure. The cost of materials was affected by mainly inflation-related price increases, as well as by volume- and severity-driven increases. Overall, the cost of materials ratio worsened year-on-year to 24.6% (2022: 24.3%).

Staff costs climbed by EUR 201.1 million to EUR 3,660.3 million on the basis of collective agreements and due to the increase in full-time equivalents, while the staff costs ratio rose to 67.1% (2022: 65.4%). “We are countering the shortage of qualified staff with our strategy of attracting full-time staff on the international labour market too. Here we will continue to take action. We know that medical professionals are essential for the quality of treatment,” explains PD Dr med. Sara Sheikhzadeh, CMO at Asklepios.

Other operating expenses rose by EUR 69.8 million (14.3%) to EUR 558.1 million (2022: EUR 488.3 million). The ratio was 10.2% (2022: 9.2%). Consolidated net income (EAT) amounted to EUR 135.7 million in the financial year (2022: EUR 131.9 million), while the margin was unchanged year-on-year at 2.5%.

The equity ratio as at 31 December 2023 was below the previous year’s figure at 29.4% (31 December 2022: 29.7%). As at 31 December 2023, net debt amounted to EUR 1,767.3 million (31 December 2022: EUR 1,871.8 million). The net debt ratio was reduced to 3.3x (31 December 2022: 3.5x).

“Asklepios’ balanced financing strategy allows it to counter macroeconomic fluctuations and structural challenges effectively,” explains Hafid Rifi, CFO of Asklepios. “In view of the upcoming hospital reform and the anticipated significant strain on our healthcare facilities, our stable capital structure is particularly important.”

Asklepios expects the war in Ukraine, the resulting price hikes and general cost inflation to continue to impact the business development and performance in 2024. As a large hospital group, Asklepios was able to react comparatively flexibly to changes in the market and to absorb negative influences to a manageable extent. In addition to the challenging regulatory environment, Asklepios also assesses the upcoming hospital reform as critical. Overall, however, Asklepios anticipates a stable revenue and earnings performance in the 2024 financial year.

 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 this basis, Asklepios has developed dynamically since it was founded almost 40 years ago. The Group now has more than 164 healthcare facilities across Germany, including acute care hospitals for all levels of care, university hospitals, specialist clinics, psychiatric and forensic facilities, rehabilitation clinics, nursing homes and medical centres. Around 3.5 million patients were treated at the Asklepios Group’s facilities in the 2023 financial year. The company has over 68,000 employees.

IR contact:
Mirjam Constantin
Head of Corporate & ESG Reporting/Investor Relations
Asklepios Kliniken GmbH & Co. KGaA
Debusweg 3 – 61462 Königstein-Falkenstein
Phone: +49 61 74 90-1166
ir@asklepios.com

PR contact:
Rune Hoffmann
Head of Corporate Communication & Marketing
Asklepios Kliniken GmbH & Co. KGaA
Rübenkamp 226 – 22307 Hamburg
Phone: +49 40 1818-82 6630
Fax: +49 40 1818-82 6639
presse@asklepios.com

Visit Asklepios online, on Facebook or on YouTube:
www.asklepios.com
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MPH Health Care AG: Preliminary IFRS result 2023

Equity (net asset value) increases by almost 30 million euros to 251.0 million euros, which corresponds to 58.62 euros per share. EBIT increases to 30.2 million euros. The equity ratio rises to 94.2%.

Berlin, 25 April 2024 – MPH Health Care AG (ISIN: DE000A289V03) announces the preliminary IFRS consolidated result for the 2023 financial year. Accordingly, equity increased from EUR 221.4 million to EUR 251.0 million. The net asset value (NAV) per share rose by 13.3% from EUR 51.72 (31 December 2022) to EUR 58.62 as of
31 December 2023.

In the 2023 financial year, preliminary EBIT totalled EUR 30.2 million (previous year: EUR 29.6 million) and the IFRS net profit for the year was EUR 29.5 million (previous year: EUR 29.1 million). As of 31 December 2023, equity increased by EUR 29.6 million to EUR 251.0 million (previous year: EUR 221.4 million). The equity ratio rose to 94.2% (previous year: 93.4%) and remains at a very high level.

MPH AG is an investment company whose investments are recognised as financial assets under the balance sheet item “Financial assets” and are measured at fair value through profit or loss as at the balance sheet date. The net profit for the year is mainly the result of the fair value measurement of the listed investments held as at the balance sheet date, resulting from the higher market prices of the investments compared to the previous year’s balance sheet date. 

The investments M1 Kliniken AG and CR Energy AG, which are listed on the Frankfurt Stock Exchange, were operationally successful in 2023.

In the past financial year 2023, M1 Kliniken AG further expanded its market position in the field of cosmetic medicine and opened four new specialist medical centres in Germany and abroad. With the opening of the Bucharest and Sofia locations, the expansion in Eastern Europe, whose target markets are considered lucrative by the company, will continue. Sales in the “Beauty” segment rose by 18% to EUR 70.8 million (previous year: EUR 60.2 million). The EBIT margin in this segment increased from 11.7% in the previous year to 21.9%.

According to the preliminary IFRS figures, the M1 Group’s consolidated sales increased by around 11% to EUR 316.3 million in the 2023 financial year (previous year: EUR 285.3 million). The M1 Group’s 2023 operating profit (EBIT) increased by 68% to EUR 15.7 million (previous year: EUR 9.3 million). Earnings before taxes in the 2023 financial year totalled EUR 16.4 million (previous year: EUR 10.2 million).

Equity increased by EUR 0.6 million to EUR 143.7 million as of 31 December 2023 (previous year: EUR 143.1 million). The equity ratio decreased slightly from 72.6% in the previous year to 66.8%. The share price of M1 Kliniken AG rose by 23.6% from EUR 9.06 on 31 December 2022 to EUR 11.20 on 31 December 2023.

CR Energy AG and its portfolio companies continue to benefit from the high popularity of their offerings in the markets for sustainable energy supply concepts, quality and cost-optimised housing and capital investments for broad sections of the population. According to the preliminary figures for the 2023 financial year, EBIT of EUR 65 million was achieved (previous year: EUR 76.3 million). CR Energy’s cash and cash equivalents increased significantly to around EUR 19.5 million as of 31 December 2023 (previous year: EUR 16.3 million) as a result of the good performance of the investments. The equity ratio remained high at around 97%. CR Energy is increasingly involved in the areas of renewable energy supply and sustainable living, whose markets have a volume in the billions.

The CR Energy AG share price fell from EUR 32.00 on 31 December 2022 to EUR 28.90 on 31 December 2023.

“Despite the ongoing conflict situation in Ukraine and the Middle East and the persistently high energy costs, we are confident about the development in 2024. The M1 Group will continue to drive profitable sales growth at its domestic and foreign locations. The plan is to grow from the current 61 locations to around 80-100 locations by the end of 2025. With its vertically integrated investment portfolio, CR Energy AG is very well positioned in the areas of “sustainable energy supply concepts” and “quality and cost-optimised living space”. MPH AG will also be able to systematically benefit from the positive developments of the investments in the coming years,” says Patrick Brenske, CEO of MPH.

 

About MPH Health Care AG:

MPH Health Care AG is an investment company with a strategic focus on the acquisition, development and sale of companies and company shares, particularly in growth segments of the healthcare market. This includes both insurance-financed and privately financed segments. However, MPH also utilises potential outside the healthcare market in high-growth and profitable sectors.

Contact:
Patrick Brenske, Management Board
Corporate Communications
E-Mail: ir@mph-ag.de

Heidelberg Pharma AG: Interim Management Statement on the First Three Months of 2024

• First efficacy data from the clinical trial with HDP-101 in multiple myeloma
• Professor Andreas Pahl becomes Chief Executive Officer
• Successful financing activities
• Sale of a portion of future royalties for Zircaix™ to HealthCare Royalty finances further development of the ADC pipeline

Ladenburg, Germany, 25 April 2024 – Heidelberg Pharma AG (FSE: HPHA) today reported on the first three months of fiscal year 2024 (1 December 2023 – 29 February 2024) and the Group’s financial figures.

Professor Andreas Pahl, CEO of Heidelberg Pharma AG, commented: “We are very pleased to see the first efficacy data in multiple myeloma in the clinical trial with our ATAC candidate HDP-101. In three patients from the fifth cohort, we have observed an objective improvement in the disease (“partial remission”). We will optimize the dosing regimen for the sixth cohort. HDP-101 was recently granted orphan drug status by the FDA for the treatment of multiple myeloma; this underlines the potential of our Amanitin-based ADC candidate in this indication.”

Walter Miller, CFO of Heidelberg Pharma AG, added: “In the first quarter of the financial year, we also successfully worked on financing the company and our ADC activities and concluded an attractive, non-equity-dilutive agreement with HealthCare Royalty in March. The upfront payment received at the end of March and the expected further payments from the partial sale of future royalties from the worldwide sale of Zircaix^TM provide a very solid financing basis and will help us to accelerate the expansion of our ADC pipeline.”

Important operational developments and achievements

• HDP-101 (BCMA ATAC) development program: The ATAC product candidate HDP-101 is being evaluated in a Phase I/IIa clinical trial for the treatment of relapsed or refractory multiple myeloma. The first four patient cohorts and dose levels have been completed and proved to be safe and well tolerated. Since September 2023, patients in the fifth cohort have been treated with a dose of 100 µg/kg HDP-101. After the initial administration of HDP-101, a temporary drop in thrombocyte count occurred in all patients. However, this normalized within a few days, with counts returning to clinically unremarkable levels.
  In order to mitigate the effect of the initial administration, an adjustment and optimization of the medication regimen was developed. The corresponding protocol adjustments were implemented and recruitment of the sixth cohort was started.
  Encouragingly, the fifth cohort showed biological activity in three out of five patients, who continued on 100 µg/kg, and an objective improvement in the disease was detected (“partial remission”). In addition, one of the study participants from the third cohort has been treated with HDP-101 as a monotherapy since January 2023 and showed a stabilization of the course of disease (“stable disease”).
• New Chief Executive Officer: Dr. Jan Schmidt-Brand, long-standing CEO of Heidelberg Pharma AG and Managing Director of the subsidiary Heidelberg Pharma Research GmbH, stepped down from his positions on 31 January 2024 upon reaching retirement age. The Supervisory Board appointed Professor Andreas Pahl as CEO with effect from 1 February 2024. Professor Pahl also assumed the role of Managing Director of the subsidiary. Professor Pahl has been Head of Research & Development at Heidelberg Pharma since 2012 and has been a member of the Executive Management Board since 2016. He holds a doctorate in chemistry and has more than 25 years of experience in the pharmaceutical industry as well as in research and teaching.

Events after the reporting period

• Agreement closed with HealthCare Royalty on the sale of a portion of future royalties: In early March 2024, Heidelberg Pharma signed an agreement with HealthCare Royalty, Delaware, USA, (HCRx) for the sale of a portion of future royalties from global sales of Zircaix™. Heidelberg Pharma received a non-refundable upfront payment of USD 25 million and is also entitled to up to an additional USD 90 million from the sale of the royalties, if defined milestones are met. Once HCRx has received a maximum cumulative amount, the royalties will revert to Heidelberg Pharma and HCRx will receive a low single-digit percentage of royalties.
  Zircaix^TM is a radiolabeled form of the antibody girentuximab which binds to the tumor-specific antigen CAIX on clear cell renal cell carcinomas. Heidelberg Pharma developed the antibody up to a first completed Phase III clinical trial prior to licensing it to Telix Pharmaceuticals Limited, a company based in Melbourne, Australia, in 2017. Telix submitted its Biologics License Application (BLA) under a rolling review submission with the US Food and Drug Administration (FDA) in December 2023 and expects market approval by the end of 2024. Recently, Telix announced that the BLA is due for completion by end-May 2024. Telix has requested a Priority Review as well.
• Orphan drug designation granted by FDA for HDP-101: At the end of March, Heidelberg Pharma announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101. Orphan Drug Designation is granted for a drug or biological product that is intended for the prevention, diagnosis, or treatment of rare diseases or disorders that affect fewer than 200,000 people in the US. The designation provides significant incentives to promote the development of the drug including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.

Results of operations, financial position and net assets

The Heidelberg Pharma Group – as of the reporting date comprising Heidelberg Pharma AG and its subsidiary Heidelberg Pharma Research GmbH – reports consolidated figures. The reporting period referred to below concerns the period from 1 December 2023 to 29 February 2024 (Q1 2024).

In the first three months of fiscal year 2024, the Group generated sales revenue and income totaling EUR 1.9 million (previous year: EUR 2.2 million). This figure includes sales revenue of EUR 1.3 million (previous year: EUR 2.1 million), which is made up of a roughly from deferred sales.

Other income amounted to EUR 0.6 million (previous year: EUR 0.1 million) and primarily consisted of the reversal of unutilized provisions that were subject to the statute of limitations.

Operating expenses including depreciation and amortization totaled EUR 6.6 million in the reporting period (previous year: EUR 8.7 million). Cost of sales amounted to just under EUR 30 thousand and was therefore significantly below the previous year’s figure of EUR 1.4 million, which is due to the high proportion of deferred income in sales. Research and development costs decreased year-on-year to EUR 5.1 million (previous year: EUR 5.8 million) and represented the largest cost item at 77%. Both periods were primarily characterized by the cost-intensive external manufacturing for the ATAC projects and the ongoing clinical trial with HDP-101. Administrative costs increased slightly to EUR 1.2 million in the first quarter of fiscal year 2024 compared to the prior-year period (EUR 1.1 million). Among others, this figure includes holding company costs and costs related to the stock market listing. Other expenses, comprising the costs incurred for business development, marketing and commercial market supply, halved from EUR 0.4 million to EUR 0.2 million year-on-year.

The Heidelberg Pharma Group’s net loss for the first three months of the fiscal year decreased to EUR 4.5 million, as planned (previous year: EUR 6.6 million). Basic earnings per share based on the weighted average number of shares issued during the reporting period improved from
EUR -0.14 in the previous year to EUR -0.10 in the reporting quarter as a result of the lower loss.

Total assets as of 29 February 2024 amounted to EUR 61.7 million and were lower compared to the 30 November 2023 reporting date (EUR 70.4 million) as a result of the loss for the period and reduced liabilities and the associated lower cash. At EUR 45.1 million, equity was also significantly lower compared to the end of fiscal year 2023 (EUR 49.3 million). This corresponds to an equity ratio of 73.2% (30 November 2023: 70.1%). No corporate actions were implemented during the reporting period. The share capital of Heidelberg Pharma AG therefore remained steady at EUR 46,604,977, divided into 46,604,977 no par value bearer shares.

Cash as of the end of the quarter amounted to EUR 32.6 million (30 November 2023: EUR 43.4 million). Heidelberg Pharma thus recorded an average cash outflow of EUR 3.6 million per month in the first quarter of the fiscal year (previous year: EUR 3.7 million).

Financial outlook for 2024

The Executive Management Board expects the Heidelberg Pharma Group to generate between EUR 11.0 million and EUR 15.0 million in sales revenue and other income (2023: EUR 16.8 million) in the 2024 fiscal year. This does not yet include the upfront payment of USD 25 million received from HCRx and its effects on operational planning. This inflow was used to repay the remaining shareholder loan of EUR 5 million and substantial additional funds from the partial sale of royalties will be used in the short term to accelerate further ADC projects. Sales revenue from major new license agreements was not included in this planning.

Operating expenses in 2024 are expected to be between EUR 36.0 million and EUR 40.0 million if business develops as planned, and thus roughly at the level of the 2023 reporting year (EUR 38.0 million). This guidance does not include any adjustments to the R&D budget due to the cash inflow from HCRx.

An operating result of between EUR -23.5 million and EUR -27.5 million is expected for 2024 (2023: EUR -21.2 million).

Gross funds used are expected to be between EUR 28.0 million and EUR 32.0 million in the 2024 financial year. This corresponds to an average monthly use of cash of between EUR 2.3 million and EUR 2.7 million (2023: EUR 3.2 million). Based on current planning, the Group is financed until mid-2025, but assumes that the cash reach will be extended due to further expected payments from the agreement with HCRx.

A conference call on this interim management statement will not take place. The complete figures for the interim financial statements can be downloaded from http://www.heidelberg-pharma.com/ ”Press & Investors > Announcements > Financial Reports > Interim management statement on the first three months of 2024″.

Key figures for the Heidelberg Pharma Group (unaudited)

In EUR thsd.	Q1 20241 EUR thsd.	Q1 20231 EUR thsd.
Earnings
Sales revenue	1,267	2,075
Other income	592	95
Operating expenses	(6,566)	(8,718)
of which research and development costs	(5,073)	(5,751)
Operating result	(4,707)	(6,548)
Earnings before tax	(4,445)	(6,484)
Net loss for the period / Comprehensive income	(4,494)	(6,563)
Earnings per share in EUR (basic)	(0.10)	(0.14)
Balance sheet as of the end of the period
Total assets	61,666	86,476
Cash	32,650	65,011
Equity	45,114	60,165
Equity ratio2 in %	73.2	69.6
Cash flow statement
Cash flow from operating activities	(10,748)	(10,740)
Cash flow from investing activities	(42)	(302)
Cash flow from financing activities	(29)	(5,026)
Employees (number)
Employees as of the end of the period3	111	109
Full-time equivalents as of the end of the period3	98	100

1 The reporting period begins on 1 December and ends on 28/29 February.
2 Equity / total assets
3 Including members of the Executive Management Board
Rounding of exact figures may result in differences.

About Heidelberg Pharma

Heidelberg Pharma develops novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma is the first company to use the mushroom toxin Amanitin in cancer therapy by exploiting the toxin’s biological mechanism of action with its innovative ATAC technology as a new therapeutic modality. It offers the opportunity to overcome resistance of cancer cells against therapeutic agents currently used and to eliminate dormant tumor cells, which typically survive current therapies and are responsible for tumor relapse and metastasis. This could lead to significant advances in cancer therapy – even for patients who no longer respond to any other treatment. The most advanced product candidate HDP-101 is a BCMA-ATAC for the indication multiple myeloma, which is currently in clinical development.

In addition to Amanitin, alternative payloads also expand the ADC platform technologies of Heidelberg Pharma to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors.

Heidelberg Pharma AG is a biopharmaceutical company based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com.

ATAC^® is a registered trademark of Heidelberg Pharma Research GmbH.

 

Contact Heidelberg Pharma AG Sylvia Wimmer Director Corporate Communications Tel.: +49 89 41 31 38-29 E-mail: investors@hdpharma.com Gregor-Mendel-Str. 22, 68526 Ladenburg	IR/PR-Support MC Services AG Katja Arnold (CIRO) Managing Director & Partner Tel.: +49 89 210 228-40 E-mail: katja.arnold@mc-services.eu
International IR/PR-Support Optimum Strategic Communications Mary Clark, Zoe Bolt, Katie Flint Tel: +44 20 3882 9621 E-mail: HeidelbergPharma@optimumcomms.com

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will”, “should”, “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

 

Press release // April 25, 2024

Formycon reports audited annual results for the financial year 2023 – Looking back on a successful operative year and exceeded guidance

• Preliminary results 2023 confirmed
• Group revenue increases by 83% compared to the previous year to a total of € 77.7 million
• Positive Group EBITDA of around € 1.5 million and adjusted Group EBITDA of € 13.3 million reflect the company’s operating success
• Group net result stand at € 75.8 million due to one-off, non-cash adjustments in the context of financial income
• Working capital as at the reporting date increased significantly to € 38.9 million, including cash and cash equivalents of € 27.0 million,
• 2024 guidance reflects a year of transition and continuing investment in a sustainable biosimilar pipeline towards medium-term EBITDA profitability
• Invitation to today’s conference call at 15:00 (CEST)

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today published audited figures and the annual report for the 2023 financial year and provides an outlook for 2024.

“The growth rates prove it: biosimilars are on a successful path worldwide. And Formycon is not only part of this process, but we are on our way to become a driving force step by step. In 2023, we reached all the operational milestones we had set and therewith laid the foundations for a successful and profitable future. For example, our first biosimilar FYB201 had a remarkable market launch in the US and is gradually entering other countries and regions. We have made important progress in the development of the biosimilar candidates FYB202 and FYB203. For both, we have submitted applications for approval in the US and Europe. We are convinced that these pipeline candidates will generate increasing revenues once on the market. Patients with serious diseases should have access to the best possible therapy. Our goal is to consolidate our position as one of the few pure-play biosimilar developers and to further expand this position in a dynamic growth environment” explained Dr. Stefan Glombitza, CEO of Formycon AG.

Enno Spillner, CFO of Formycon AG, adds: “We have presented excellent financial figures for 2023 and reached or exceeded the guidance. Our positive economic development confirms our strategy to continuously invest in our biosimilar pipeline to ensure the rapid and parallel progress of our projects. For us, 2024 will therefore mark a year of transition and investment underpinning the basis for sustainable growth and report positive EBITDA contributions in the medium term. The biosimilar market is growing rapidly, and we are ideally positioned to utilize this potential.”

Increasing revenue due to milestone payments from the FYB202 project, revenue shares from FYB201 sales, and income from development services

In 2023, revenues increased to around € 77.7 million (2022: € 42.5 million), which corresponds to growth of around 83% compared to the previous year. Therefore, revenues were within the guided corridor of between € 75 million and € 85 million. In addition to income from development services for the partnered projects FYB201 and FYB203, a significant proportion of revenue resulted from several milestone payments due to the commercialization partnership concluded with Fresenius Kabi for the FYB202 project in the first quarter of 2023. Of these, a milestone payment anticipated for 2024 was already partially realized in advance and reported in the financial year 2023 as a correspondingly deferred, expected success payment.

The marketing of the ranibizumab biosimilar FYB201, which is now available in a total of 17 countries worldwide, also contributed to an increase in revenue and net earnings contributions. Revenue resulting from direct participation in the marketing of the Lucentis®[1] biosimilar FYB201 amounted to around € 4.1 million. A further significant part of the FYB201 revenue was realized as part of the 50% at equity investment in Bioeq AG and is therefore not shown directly in the revenue but below EBITDA. For the financial year 2023, the at-equity result totaled to € 11.8 million (2022: € -12.9 million), which is included in the newly established key performance indicator “adjusted Group EBITDA” and thus reflects the overall operating performance including the FYB201 marketing success.

Positive EBITDA and adjusted Group EBITDA reflect the Group’s operating performance

Contrary to the original guidance, which was in the range of € -5 million to € -15 million, consolidated earnings before interest, taxes, depreciation and amortization (EBITDA) were positive for the full year and amounted to around € 1.5 million (2022: € -15.9 million). This result is mainly due to the increase in revenue and significantly lower than originally anticipated investments in the 2023 deprioritized COVID-19 project FYB207.

In future reporting, Formycon will replace the previous financial performance indicator “consolidated net result” with the new indicator “adjusted Group EBITDA”. From the management’s perspective, the net result is significantly influenced by the fair value assessment of the contingent purchase price payment from the transaction with ATHOS in 2022, which in turn depends on various external factors (such as the applicable interest rate (WACC)). Due to the high volatility of these factors, net result, at the company’s current stage, does not adequately reflect the operational performance of the business model after taxes, considering all expenses and revenues for the relevant period.

As a result of the outlined effects, the Group net result encompasses non-cash adjustments in financial income, culminating in a total of € 75.8 million (2022: € 36.0 million, including a one-off effect) and is therefore above the guided range of € 50 million to € 60 million.

The adjusted Group EBITDA aims to present the total revenue from the FYB201 project, which is partially reported below EBITDA as at equity results due to the existing 50% stake in Bioeq AG, as regular operating income. This adjustment facilitates a clearer emphasis on the direct financial contributions of FYB201 to the business success of the Formycon Group and provides a more transparent insight into the company’s actual operational performance.

The adjusted Group EBITDA for the 2023 financial year totaled to € 13.3 million (2022: € -28.8 million), which is particularly attributable to the significantly increased earnings contributions from Bioeq AG, amounting to € 11.8 million (2022: € -12.9 million).

Solid Working Capital

As of December 31, 2023, the Formycon Group’s working capital amounted to approximately € 38.9 million (December 31, 2022: € 14.0 million) and included cash and cash equivalents of € 27.0 million (December 31, 2022: € 9.8 million). It was thus above the guidance corridor of between € 15 million and € 25 million. Besides the successful business performance in the year under review, the increase in cash and cash equivalents can be attributed to the capital increase carried out in February 2023 with gross proceeds of € 70.1 million, while simultaneously the shareholder loan was redeemed by € 20.0 million.

The years 2023 and 2024 will pave the way for further product launches starting in 2025

The targeted development and the continuous expansion of the biosimilar pipeline forms the foundation for Formycon’s long-term growth and profitability. As planned, Formycon has by the end of 2023 submitted the applications for approval for the two late-stage biosimilar candidates FYB202 (Ustekinumab) and FYB203 (Aflibercept) to the FDA and EMA. From a regulatory perspective, the main focus of 2024 will be the upcoming approval decisions in the USA and Europe for these two promising biosimilar candidates.

In addition, preparations for the start of the clinical development program of FYB206 (pembrolizumab) are almost completed and Formycon plans to reach another important milestone with the treatment of the first patient (First Patient In) in the course of 2024. Formycon continues to invest in the expansion of its biosimilar platform and further extended its product pipeline last year with the two earlier biosimilar candidates FYB208 and FYB209. In addition, the plan is to continue the expansion in 2024 with the initiation of the FYB210 project.

Assuming the expected approvals and market launches as well as out-licensing of its biosimilar candidates, Formycon is aiming for a positive EBITDA in the medium term.

Outlook for the 2024 financial year

For 2024, the Formycon Group expects sales revenue of between € 55 million and € 65 million. This will mainly result from anticipated sales contributions from the marketing proceeds of FYB201, which will be launched in additional countries and regions in 2024.

In addition, there is expected revenue from development services for partnered projects FYB201 and FYB203, which are lower than in previous years due to the advanced stage of the projects. Some of the revenue from the milestone payments expected for FYB202 in 2024 were already recognized in 2023 and reported as an expected deferred success payment. Therefore, the approval-related milestone payments will not be reflected in full as revenue in 2024.

As Formycon continues to operate in an intensive investment and transition phase, the management expects EBITDA for the 2024 financial year to be in the range of € -15 million to € – 25 million. This is mainly due to the planned development costs for the biosimilar projects FYB208 and FYB209, which are progressing into more cost-intensive project phases. There are also plans to expand the portfolio with a new project, FYB210. FYB206, a biosimilar candidate for Keytruda^®[2], currently the world’s best-selling oncology product (annual sales 2023: USD 25 billion), is to enter clinical development in the course of 2024, which will lead to significant investments in the years 2024 to 2026. To achieve greater internal value creation, Formycon has made a strategic decision to develop this promising candidate independently up to the completion of the Phase I clinical trial. Due to the capitalization of the costs incurred, the investments will not be reflected in the income statement and therefore not in EBITDA.

Adjusted Group EBITDA for 2024 is expected to be in a range between € -5 million and € -15 million.

Working capital is expected to range between € 10 million and € 20 million in 2024, which is due to the investments in the FYB206 project and the full repayment of the shareholder loan. The working capital is expected to be between € 10 million and € 20 million in 2024, which is due to the investments in the FYB206 project and the full repayment of shareholder loans. The flexible shareholder credit line of up to € 48 million remains in place.

The complete Annual Report 2023 can be found on the Formycon website at Financial Reports.

The Executive Management Board of Formycon AG will discuss the development of the company and the key financial figures for the 2023 financial year in a conference call, which will be broadcasted live on the Internet on April 25, 2024 at 3:00 p.m. (CEST) in English.

To participate, please register at:

https://research-hub.de/events/registration/2024-04-25-15-00/FYB-GR

You can take part in the event via your web browser or the Zoom app.

A number of international telephone numbers are available for participation by telephone.

You can find an overview under the following link: https://zoom.us/u/aJj3tcDoQ

To dial in to the event by telephone, please use the webinar ID: 962 8767 3566

After a short presentation, the Executive Management Board will be answering questions from analysts. The conference call will be recorded and can be accessed afterwards on the Formycon website at: https://www.formycon.com/investor-relations/facts-figures/.

About Formycon:

Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Another five biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

About Biosimilars:

Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare providers. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:

Sabrina Müller
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany
Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

Disclaimer:

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

^[1]Lucentis® is a registered trademark of Genentech Inc.

^[2]Keytruda® is a registered trademark of Merck Sharp & Dohme LLC