RELIEF THERAPEUTICS Holding SA Announces Results of Extraordinary General Meeting

Relief Therapeutics Holding SA

/ Key word(s): AGMEGM

RELIEF THERAPEUTICS Holding SA Announces Results of Extraordinary General Meeting

26.04.2024 / 17:30 CET/CEST

RELIEF THERAPEUTICS Holding SA Announces Results of Extraordinary General Meeting of Shareholders Shareholders approved all proposals by a large majority

GENEVA (APR. 26, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTFRLFTY) (Relief Therapeutics, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, announces the results of the extraordinary general meeting (EGM) of shareholders, which took place in Geneva today, Friday, April 26, 2024. The proposed resolutions were approved by more than 85 percent of the represented votes.

EGM results

  1.      Election of new members of the Board of Directors

The EGM elected Mr. Peter de Svastich, Mr. Gregory Van Beek, and Mr. Thomas Elzinga as new members of the Company’s Board of Directors, for a term of office extending until completion of the next Annual General Meeting expected in June 2024. As anticipated, Ms. Patrice Jean and Mr. Thomas Plitz have concluded their service on the Board of Directors, effective today.

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief Therapeutics, commented: “We are welcoming three new board members, each with valuable expertise and fresh perspective, critical for guiding our strategic direction and enhancing shareholder value. At the same time, we express our deepest gratitude to our two departing members for their invaluable contributions and dedication in shaping our path forward.”

  1.      Capital Reduction by Reduction of Nominal Value

The EGM approved a reduction of the nominal value of the Company’s share capital from CHF 56’163’348.00 to CHF 1’404’083.70. The number of outstanding shares, as well as shareholders’ financial and patrimonial rights, are not affected by this technical adjustment.

  1.      Increase of the Conditional Share Capital

The EGM approved an increase of the existing conditional share capital to 7’000’000 shares.

  1.      Reinstatement and Extension of the Capital Band

The EGM approved an increase of the Company’s capital band to 7’000’000 shares and extended its duration until April 25, 2029.

  1.      Votes on the compensation of the members of the Board of Directors and of the Executive Committee

The EGM approved a maximum amount of CHF 500’000 for compensation of the members of the Board of Directors for the period from the Annual General Meeting 2023 until the Annual General Meeting 2024, and a maximum amount of CHF 4’000’000 for the members of the Executive Committee for the financial year 2024, inclusive of fixed and variable compensation, stock options, and other benefits.

  1.      Discharge of the Board of Directors and the Executive Committee

The EGM granted discharge to each and all members of the Board and of the Executive Committee, including former members, for the financial years 2022 and 2023.

  1.      Amendments to the Articles of Association related to the New Corporate Law

The EGM approved textual amendments to article 23 para. 1 and article 25 para. 3 of the Articles of Association for alignment with the new corporate law.

The resolutions submitted for the shareholders’ vote are detailed in the EGM invitation. The detailed voting results will be made available on the Company’s website later today.

 

ABOUT RELIEF THERAPEUTICS

Relief Therapeutics is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief Therapeutics’ portfolio offers a balanced mix of marketed, revenue-generating products, our proprietary, globally patented Physiomimic™ and TEHCLO™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief Therapeutics is commercializing several legacy products via licensing and distribution partners. Relief Therapeutics’ mission is to provide therapeutic relief to those suffering from rare diseases and is being advanced by an international team of well-established, experienced biopharma industry leaders with extensive research, development and rare disease expertise. Relief Therapeutics is headquartered in Geneva, with additional offices in Balerna, Switzerland, Offenbach am Main, Germany and Monza, Italy. Relief Therapeutics is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, please visit our website www.relieftherapeutics.com or follow Relief Therapeutics on LinkedIn.

CONTACT:
RELIEF THERAPEUTICS Holding SA

Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief Therapeutics to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief Therapeutics’ filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief Therapeutics. Copies of Relief Therapeutics’ filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief Therapeutics does not undertake any obligation to update the information contained herein, which speaks only as of this date.


Additional features:

File: Press Release_Relief_EGM Results


End of Media Release


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CHEPLAPHARM closes financial year 2023 with record revenue and double-digit growth

EQS-News: Cheplapharm AG

/ Key word(s): Annual Results/Annual Report

CHEPLAPHARM closes financial year 2023 with record revenue and double-digit growth

26.04.2024 / 11:55 CET/CEST

The issuer is solely responsible for the content of this announcement.

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

Greifswald, 26th 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

 


26.04.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
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M1 Kliniken AG decides to start share buyback

M1 Kliniken AG / Key word(s): Share Buyback

M1 Kliniken AG decides to start share buyback

26-Apr-2024 / 11:06 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group AG.

The issuer is solely responsible for the content of this announcement.


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

End of Inside Information


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STRATEC POSTS RESULTS FOR FIRST QUARTER OF 2024

EQS-News: STRATEC SE

/ Key word(s): Quarter Results

STRATEC POSTS RESULTS FOR FIRST QUARTER OF 2024

26.04.2024 / 06:55 CET/CEST

The issuer is solely responsible for the content of this announcement.

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


26.04.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
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Business Combination of Kinarus Therapeutics Holding AG (now renamed to Curatis Holding AG) and Curatis AG completed

Kinarus Therapeutics Holding AG / Key word(s): Acquisition/Corporate Action

26-Apr-2024 / 07:00 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

The issuer is solely responsible for the content of this announcement.


Ad hoc announcement pursuant to Art. 53 LR

  •  
  • The Business Combination of Kinarus Therapeutics Holding AG (now renamed to Curatis Holding AG) with Curatis AG and related transactions were completed on 25 April 2024
  • The first trading day of the combined entities, Curatis Group (CURN.SW), is today, 26 April 2024
  • A total of CHF4.36m in cash was raised in Q1 2024 in connection with the Business Combination
  • Curatis Group, a specialty pharmaceutical and therapeutic drug development company focused on orphan and ultra-orphan indications is an exciting addition to the universe of healthcare companies listed on the SIX Swiss Exchange
  • Risk-balanced business model with a mix of specialty medicine distribution and targeted own drug development activities, focusing on compounds with existing safety and efficacy data in indications with high unmet medical need
  •  

Liestal, Switzerland, 26 April 2024: Curatis Holding AG (“CURN.SW“, “Curatis Holding” or the “Company“, formerly Kinarus Therapeutics Holding AG, and together with its wholly-owned subsidiary Curatis AG, “Curatis Group“), a SIX Swiss Exchange listed specialty pharmaceutical and therapeutic speciality medicine distribution and drug development company, today announces that it has successfully completed the business combination with Curatis AG (the “Business Combination“). As of today, the CURN.SW shares of the Company, under the new name Curatis Holding AG and with a relocated domicile to Liestal, Basel-Landschaft, are trading for the first time on the SIX Swiss Exchange.

 

As initial related transactions, a reverse share split (the “Reverse Share Split”) with a reverse share split ratio of 4,480:1 (together with a small capital increase of 111 shares of the Company to make the number of shares of the Company divisible by 4,480) and a share capital reduction, whereby the nominal value of each share of the Company was reduced from CHF 44.80 (immediately post Reverse Share Split) to CHF 0.10 per share, were carried out. As a result, the 1,310,176,000 shares of the Company (i.e previous KNRS.SW shares with a nominal value of CHF 0.01 per KNRS.SW share) were split into 292,450 CURN.SW shares with a nominal value of CHF 0.10 per CURN.SW share. Concurrently and as the main transaction of the Business Combination, Curatis Holding acquired by way of contribution in kind all outstanding shares of Curatis AG in a capital increase against a total consideration of 4,093,916 newly issued CURN.SW shares. As a result of all these transactions, the total number of outstanding CURN.SW shares is now 4,386,366 registered shares with a nominal value of CHF 0.10 each.

Also, as part of the Business Combination, a Mandatory Exchangeable Loan Note with principal amount of CHF 4.55 million (the “Loan Note“) was placed with selected investors. This Loan Note has already been partially converted into new CURN.SW and, in accordance with the terms of the Loan Note, the remainder will be converted 61 trading days from today into between 112,780 and 368,699 shares, with the conversion price depending on the 60-day volume weighted average share price of the Company’s shares. With the total cash of CHF 4.36 million raised under the Loan Note, together with the net cash flow expected to be generated by the specialty medicine distribution business of the Curatis Group in the future, the Curatis Group expects to have sufficient funds to execute its base case business plan for the development of its lead product candidate C-PTBE-01.

The Curatis Group:

The Curatis Group is focused on the acquisition, development and commercialisation of innovative medicines for the prevention, diagnosis and treatment of rare diseases – often referred to as orphan diseases – and special care diseases. In recent years, orphan drugs have shown an above market growth compared to non-orphan innovative drugs in the past. Orphan drug development may be associated with a faster and less costly route to market, thereby reducing a company’s overall risk profile.

The Group also operates a distribution business with a sizeable and historically profitable portfolio of interesting, marketed orphan and specialty products in Switzerland and has a pipeline of four promising projects in advanced and late clinical development, including KIN001, a proprietary compound platform developed by Kinarus with future potential. The Curatis Group thus represents an attractive, risk-balanced business model.

Distribution business for orphan disease and specialty disease medicines

Curatis has exclusive distribution rights in Switzerland for more than 30 different drugs developed by third party pharmaceutical companies – many of them orphan and specialty drugs.

With Curatis AG now being part of a publicly listed group and the expected increase in public visibility and credibility, the Curatis Group aims to grow its speciality pharmaceuticals distribution business by expanding its product offering in Switzerland as well as geographically expanding its distribution business to large European markets such as Germany, France, the UK and Italy.

Development business for orphan and specialty disease medicines

Curatis Group’s strategy is to identify high unmet medical need indications for compounds for which safety and clinical efficacy data already exist, potentially allowing faster development with lower risk and investment through to commercialisation. The development projects have been selected in line with this strategy.

C-PTBE-01 for the treatment of peritumoral brain edema in pediatric patients with diffuse intrinsic pontine glioma (“DIPG”) – next major development step: pivotal clinical study

The Group is focusing its development activities for C-PTBE-01 on peritumoral brain edema (PTBE) in pediatric patients with diffuse intrinsic pontine glioma (DIPG). DIPG is an aggressive type of childhood cancer that forms in the brain stem. It is very rare and almost always occurs in the pediatric population. Approximately 150-300 patients are diagnosed with DIPG each year in the US. The average (median) overall survival for patients with DIPG is less than 1 year. PTBE refers to the accumulation of fluid in the brain tissue surrounding a tumor. It commonly occurs in brain tumors and can cause significant neurological symptoms and complications due to increased pressure within the skull. It may lead to symptoms such as headaches, seizures, neurological deficits, and altered mental status.

Given the lack of curative options for most DIPG patients, supportive therapy aimed at maintaining quality of life plays a central role in the treatment of many patients. Corticosteroids are commonly used to treat PTBE. Their administration is typically associated with rapid symptom relief. However, corticosteroids can have severe side effects such as severe myopathies, muscle wasting, morbid weight gain, osteoporosis, gastritis, gastrointestinal bleeding, hypertension, and personality changes.

C-PTBE-01 has shown a strong corticosteroid-sparing effect, which may allow a significant reduction in corticosteroid use. Phase I, II and III clinical data are available, and thus Curatis Group currently expects that only a pivotal study with a relatively small number of patients is envisioned for registration. C-PTBE-01 may be eligible for 7 years of orphan drug protection in the US and 10 years of orphan drug protection in the EU upon orphan drug designation and receiving market authorization. Curatis Group may apply for a Rare Pediatric Disease Voucher for C-PTBE-01.

C-AM-01 for the prevention of severe migraine with aura (“MwA“) – next major development step: clinical phase IIb study

An aura typically is a perceptual disturbance and includes a wide range of neurological symptoms. In some patients, changes in the cortex area of the brain cause changes in their sight, such as dark spots, colored spots, sparkles or ‘stars’, and zigzag lines. Numbness or tingling, weakness, and dizziness or vertigo (the feeling of everything spinning) can also happen. Speech and hearing can also be disturbed, and sufferers have reported memory changes, feelings of fear and confusion, and more rarely, partial paralysis or fainting.

Migraine with Aura is a high unmet medical need indication. There is no approved preventive treatment that specifically targets MwA and its associated headache. MwA can cause significant disability on patients and compromise their daily life activity. MwA attacks are comparable to epileptic attacks in terms of unexpectedness and instant disability. MwA patients are 3 times more likely to have an ischemic stroke.

Two Phase IIa clinical proof-of-concept studies suggest a reduction in the number of auras with C-AM-01. C-AM-01 has been granted a US patent covering its use and dosing regimen. In the EU, C-AM-01 would benefit from 10 years of data exclusivity and market protection.

C-MOH-01 for the treatment and prevention of medication overuse headache (“MOH”) – next major development step: clinical phase IIb study

Headache is one of the most prevalent disorders in human society and is responsible for substantial socioeconomic expenses. A general problem of headache treatment is the overuse of drugs. Patients, who tend to use acute medication to treat their headache on a frequent basis, like patients who report a history of migraine as well as patients that report tension type headache (TTH) are predestined for medication overuse headache (MOH). Instead of curing the pain, overuse leads to even heavier secondary headache which is much more difficult to treat and is referred to as Medication Overuse Headache (“MOH“). Economically, medication overuse headache is among the costliest of neurologic diseases and the costliest kind of headache disorder.

Currently the treatment of choice for MOH is discontinuation of the overused medication although this is often associated with acute headache pain and withdrawal symptoms such as sleep disturbances, nausea, vomiting, anxiety, and depression. Thus, there is a significant unmet need for patients suffering from MOH.

One Phase IIa clinical proof-of-concept study in chronic tension type headache is available for C-MOH-01. C-MOH-01 has been granted a US patent covering its use. In the EU, C-MOH-01 would benefit from 10 years of data exclusivity and market protection.

KIN001 for the treatment of rare inflammatory and fibrotic diseases (e.g. idiopathic pulmonary fibrosis (“IPF”)) – next major development step: clinical proof-of-concept

KIN001, developed by Kinarus, is a proprietary compound with potential in inflammatory and fibrotic diseases. KIN001 adds a significant new element to the Group’s pipeline. The Curatis Group intends to explore the potential of KIN001 in ultra-orphan inflammatory and fibrotic diseases and to pursue its own drug development for the identified ultra-orphan indications.

The Curatis Group also plans to pursue KIN001 in idiopathic pulmonary fibrosis (“IPF”). IPF is a rare, progressive orphan disease of the respiratory system characterised by thickening and stiffening of lung tissue associated with the formation of scar tissue. It is a type of chronic scarring lung disease characterised by a progressive and irreversible decline in lung function. The tissue in the lungs becomes thick and stiff, affecting the tissue surrounding the air sacs in the lungs. Symptoms typically include gradual shortness of breath and a dry cough. Other changes may include fatigue and abnormally large and dome-shaped finger and toenails (nail clubbing). Complications may include pulmonary hypertension, heart failure, pneumonia or pulmonary embolism.

There is no cure for IPF and there are currently no procedures or medicines that can remove the scarring from the lungs. Current treatments are focused on slowing the progression of lung scarring and do not necessarily reduce the symptoms of coughing and breathlessness.

KIN001 has shown beneficial effects in reducing IPF in a well-characterised animal model of IPF. The Curatis Group has licensed patent rights relating to the drug combination as well as patent rights and know-how relating to IPF in this drug combination. The Group intends to explore out-licensing opportunities in IPF.

The following graph is a projected Development Roadmap. It shows the currently assumed development plan of the Curatis Group’s product candidates, highlighting potentially important inflection points over the next 5 years.

Development Roadmap

About the Curatis Holding Group:

Curatis Holding AG is a publicly listed specialty pharmaceutical company with a distribution and drug development business. The focus of the Curatis Group’s business activities is on high unmet medical need orphan and ultra-orphan indications, pursued via its wholly owned operating subsidiary Curatis AG. The Curatis Group was formed by the Business Combination of Kinarus Therapeutics Holding AG and Curatis AG in April 2024.

For more information, please visit the company’s website at www.curatis.com.

Investor Relations Contact:

YUMA Capital
Thomas Bieri
Managing Partner
Tel: +41 44 575 20 01

thomas.bieri@yuma-capital.com

 

Disclaimer:
THIS DOCUMENT DOES NOT CONSTITUTE A PROSPECTUS WITHIN THE MEANING OF SWISS FINANCIAL SERVICES ACT (“FINSA”), NOR A PROSPECTUS UNDER ANY OTHER APPLICABLE LAWS AND SHOULD NOT BE TREATED AS OFFERING MATERIALS OF ANY SORT AND IS FOR INFORMATION PURPOSES ONLY. THE INFORMATION CONTAINED HEREIN IS IN SUMMARY FORM AND MUST BE CONSIDERED IN CONJUCTION WITH AND SUBJECT TO THE PUBLICLY AVAILABLE INFORMATION OF CURATIS HOLDING AG. THIS DOCUMENT IS BEING FURNISHED TO YOU SOLELY FOR YOUR INFORMATION AND MAY NOT BE REPRODUCED, REDISTRIBUTED OR MADE AVAILABLE IN WHOLE OR IN PART TO ANY OTHER PERSON OR ANY PURPOSE, WITHOUT THE PRIOR WRITTEN CONSENT OF CURATIS HOLDING AG. THIS DOCUMENT CONSTITUTES ADVERTISMENT WITHIN THE MEANING OF ARTICLE 68 OF THE FINSA.

This document contains certain forward-looking statements. Other written materials, as well as other written and oral statements made to the public, may also contain forward-looking statements. Forward-looking statements can be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” “may,” “could,” “would,” “anticipate,” “seek,” or similar terms, or by express or implied discussions regarding potential new products, potential new indications for existing products, or regarding potential future revenues from any such products; or regarding the potential outcome, or financial or other impact on Curatis Holding AG, of any of the transactions described; or regarding potential future sales or earnings of the group or any of its divisions or potential shareholder returns; or by discussions of strategy, plans, expectations or intentions. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements.

This document is not an offering circular or prospectus and is being furnished to you solely for your information and may not be reproduced, redistributed or made available in whole or in part to any other person for any purpose, without the prior consent of Curatis Holding AG. This document is for information purposes only and is not to be relied upon in substitution for the exercise of independent judgement. It is not intended as investment advice and under no circumstances is it to be used or considered as an offer to sell, or a solicitation of an offer to buy, any security nor is it a recommendation to buy or sell any security. Any decision to subscribe to any securities should only be made on the basis of an independent review by you of Curatis Holding AG publicly available information. Curatis Holding AG does not accept any liability arising from the use of, or make any representation as to the accuracy or completeness of, this document or the publicly available information on Curatis Holding AG. We provide the information in this document as of the date hereof and the information contained in this document is subject to change at any time. We do not intend, and do not assume any obligation, to update any information or forward-looking statements set out in this document as a result of new information, future events or otherwise. Curatis Holding AG shall not be responsible for, or for investigating, any matter which is the subject of any statement, representation, warranty or covenant of Curatis Holding AG contained in any agreement or document relating to a transaction (including to the Business Combination with Curatis AG announced with a media release on 29 January 2024), or for the execution, legality, effectiveness, adequacy, genuineness, validity, enforceability or admissibility in evidence thereof. This document is not for distribution, directly or indirectly in or into the United States (as defined in Regulation S under the US Securities Act of 1933, as amended (“US Securities Act”)).  This document is not an offer to sell securities, or the solicitation of any offer to buy securities, nor shall there be any offer of securities in any jurisdiction in which such offer or sale would be unlawful. The securities mentioned in this document have not been and will not be registered under the US Securities Act, and may not be offered or sold in the United States absent registration or exemption from registration under the US Securities Act. There will be no public offer of the securities in the United States or in any other jurisdiction. In connection with the Business Combination there has not been, nor will there be, any public offering of any securities in any jurisdiction in and outside of Switzerland. The securities in connection with the Business Combination may not be offered to the public in any jurisdiction in circumstances which would require Curatis AG or Curatis Holding AG to prepare or register any prospectus or offering document relating to the securities in connection with the Business Combination in such jurisdiction. No action has been taken or will be taken in any jurisdiction outside of Switzerland by Curatis AG and Curatis Holding AG that would, or is intended to, permit a public offering of the securities in connection with the Business Combination in such jurisdiction.

 

News Source: Kinarus Therapeutics Holding AG


End of Inside Information


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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-Gen CRC Test

Issuer: Mainz BioMed N.V.

/ Key word(s): Study results

25.04.2024 / 15:29 CET/CEST

The issuer is solely responsible for the content of this announcement.

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.


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1.6 million euros for Hanf Farm: Federal Ministry for Economic Affairs and Climate Protection funds bio-economy project (news with additional features)

EQS-News: SYNBIOTIC SE

/ Key word(s): Financing

1.6 million euros for Hanf Farm: Federal Ministry for Economic Affairs and Climate Protection funds bio-economy project (news with additional features)

25.04.2024 / 12:33 CET/CEST

The issuer is solely responsible for the content of this announcement.

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


Additional features:

File: SBX Hanf Farm BMWK


25.04.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
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Asklepios Group: Asklepios shows resilience in 2023 financial year

EQS-News: Asklepios Kliniken

/ Key word(s): Annual Report

Asklepios Group: Asklepios shows resilience in 2023 financial year

25.04.2024 / 10:00 CET/CEST

The issuer is solely responsible for the content of this announcement.

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
gesundleben.asklepios.com
www.facebook.com/asklepioskliniken
www.youtube.com/asklepioskliniken
Nursing blog: “Wir sind Pflege
Sign up for the Asklepios newsletter: https://www.asklepios.com/konzern/newsletter-anmeldung/


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MPH Health Care AG: Preliminary IFRS result 2023 Equity 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.

EQS-News: MPH Health Care AG

/ Key word(s): Preliminary Results/Annual Results

MPH Health Care AG: Preliminary IFRS result 2023 Equity 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.

25.04.2024 / 08:30 CET/CEST

The issuer is solely responsible for the content of this announcement.

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


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

EQS-News: Heidelberg Pharma AG

/ Key word(s): Quarterly / Interim Statement

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

25.04.2024 / 07:21 CET/CEST

The issuer is solely responsible for the content of this announcement.

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 ZircaixTM 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.
    ZircaixTM 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.

 


25.04.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
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