Press Release // July 26, 2024
 

Formycon and Fresenius Kabi receive positive CHMP opinion for FYB202 (Ustekinumab), a biosimilar candidate to Stelara^®
 

• Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommends approval of FYB202 for the treatment of severe inflammatory diseases in the fields of gastroenterology, dermatology, and rheumatology
• Approval decision by the European Commission is expected until early Q4 2024
• Fresenius Kabi is commercialization partner for FYB202 in key global markets
   

Planegg-Martinsried, Germany – Formycon AG (FWB: FYB) and its commercialization partner Fresenius Kabi jointly announce, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB202, a biosimilar candidate to Stelara^®1 (Ustekinumab) indicated for the treatment of several serious inflammatory diseases.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: „The CHMP recommendation for FYB202, our biosimilar candidate to Stelara^®, is an important prerequisite for approval by the European Commission. With FYB202, more patients with serious chronic inflammatory diseases will have access to high-quality and affordable therapies. This recommendation is an additional confirmation of our great expertise in development and in the regulatory area. Economically, the Stelara® biosimilar is expected to significantly increase Formycon revenues following its global launch and thus contribute to sustainable EBITDA profitability in the medium term.“

Within the approval process, the CHMP’s positive opinion represents an important regulatory step towards the approval of FYB202 in the European Union. The CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization valid in all EU member states, which is expected until early Q4 2024.

Ustekinumab, a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, is used to treat various severe inflammatory conditions. FYB202/Ustekinumab has been recommended by the CHMP for approval in the European Union (EU) for the treatment of serious inflammatory diseases in the fields of gastroenterology, dermatology, and rheumatology. The recommendation is based on a thorough evaluation of our comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

In February 2023, Formycon and Fresenius Kabi entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets.

¹Stelara® is a registered trademark of Johnson & Johnson

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 Fresenius Kabi:
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.

Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.

Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.

For more information visit the Fresenius Kabi’s website at www.fresenius-kabi.com
For more information about the company’s work in biosimilars, please visit https://biosimilars.fresenius-kabi.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.

Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014

Stelara^® Biosimilar Candidate FYB202 (Ustekinumab) receives positive CHMP opinion from EMA

Planegg-Martinsried, Germany, July 26, 2024 – Formycon AG (FSE: FYB, “Formycon“) announces that the Committee for Medicinal Products for Human Use („CHMP“) of the European Medicines Agency („EMA“) today issued a positive opinion for FYB202, a biosimilar candidate to Stelara^®1 (Ustekinumab).

FYB202 has thus been recommended for approval in the European Union (EU) for the treatment of serious inflammatory diseases in the fields of gastroenterology, dermatology and rheumatology. The CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization, which is expected until early Q4 2024.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 and is used to treat various severe inflammatory diseases. The CHMP recommendation is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202 demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

¹⁾ Stelara^® is a registered trademark of Johnson & Johnson
 

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

phone +49 (0) 89 – 86 46 67 149
fax + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com
www.formycon.com

Disclaimer
Certain statements contained in this release may constitute “forward-looking statements” that involve a number of risks and uncertainties. Forward-looking statements can generally be identified by the use of the words “may,” “will,” “should,” “plan,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “project,” or “aim,” or the negative of these words or other variations of these words or comparable terminology. Forward-looking statements are based on assumptions, forecasts, estimates, projections, opinions or plans that, by their nature, are subject to significant risks and uncertainties and contingencies that are subject to change.

Formycon does not and will not give any assurance that any forward-looking statement will be achieved or prove to be accurate. Actual future business, financial condition, results of operations and prospects may differ materially from those projected or anticipated in the forward-looking statements. Subject to applicable legal requirements, neither Formycon nor any other person intends to update, review, revise or revise any forward-looking statements in this release to reflect actual events or developments, whether as a result of new information becoming available, new developments occurring in the future or otherwise, nor does it undertake any such obligation.

Vitruvia Medical AG half-year results as of June 30, 2024

Vitruvia Medical AG achieves results as expected in the first half of 2024. The Board of Directors confirms the forecast for the year as a whole.

Vitruvia Medical AG is on target for the first six months of 2024. The result amounted to CHF -52,968.06 compared to CHF -150,464.24 in the previous year. Based on the expected results for the first half of 2024, the company’s management confirms the outlook for the current full year. For this period, the Board of Directors expects consolidated sales of around EUR 2.0 million. On a consolidated basis, Vitruvia Medical AG anticipates a further improvement in earnings compared to the previous year.

Mainz Biomed Launches Enhanced ColoAlert with Cutting-Edge Features to Optimize Screening Efficiency and User Convenience

BERKELEY, US – MAINZ, Germany – July 25, 2024 — Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in early detection of cancer, today announced significant improvements to its ColoAlert product, currently being commercialized across Europe and in select international markets. These updates aim to enhance customer satisfaction and streamline lab operations.

ColoAlert is a highly efficacious and easy-to-use, at-home detection test for colorectal cancer (CRC). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT). It is designed to detect tumor DNA and CRC cases in their earliest stages.

To increase screening/lab efficiency, Mainz Biomed has introduced a novel DNA stabilizing buffer capable of accommodating varying sample volumes. This breakthrough addresses a common issue in the industry where samples are often either underfilled or overfilled, rendering them unsuitable for laboratory analysis. Consequently, patients frequently have to repeat their screening test.  The new proprietary buffer used in ColoAlert significantly reduces the necessity for additional sample submissions, thereby reducing the time for the patients to obtain their results. This enhancement has enabled ColoAlert to achieve the industry’s lowest retesting rates, ensuring that screening outcomes are delivered within just 2 – 3 days upon arrival at the laboratory.

Furthermore, Mainz Biomed has refined the ColoAlert kit for improved usability, including a variety of new features, such as an improved collection device, a new tube and tube holder, etc. These upgrades streamline the sample collection process, offering users a more straightforward and reliable experience.

“Our commitment to preserving DNA samples and optimizing testing procedures underscores our dedication to delivering superior colorectal cancer screening while ensuring convenience for patients,” stated Tarrin Khairi-Taraki, VP Commercial Operations at Mainz Biomed.

The updated ColoAlert product is now accessible to existing laboratory partners and readily available to prospective collaborators.

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

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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

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

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.

Dräger on track to meet annual forecast after a solid first half-year

• Order intake slightly above the high prior-year level
• Net sales still slightly down so far
• EBIT around 17 percent above the prior-year figure
• Annual forecast confirmed

Lübeck – Drägerwerk AG & Co. KGaA increased its order intake in the first half of 2024 thanks to good overall demand. At around EUR 1,604 million, order intake was around EUR 8 million above the high prior-year figure. Net sales decreased by 0.3 percent (net of currency effects) to EUR 1,520.5 million (6 months 2023: EUR 1,532.4 million) after Dräger had benefited from strong catch-up effects in the same period of the prior year as a result of the noticeable improvement in delivery capacity and a surge in demand for ventilators in China. Earnings before interest and taxes (EBIT) amounted to EUR 55.8 million (6 months 2023: EUR 47.7 million). The EBIT margin amounted to 3.7 percent (6 months 2023: 3.1 percent). In addition to the solid operating business performance, several one-time effects recognized in profit or loss contributed around EUR 20 million to EBIT. These included the sale of a non-core local business activity and the sale of a plot of land that was not required.

“Our business performed solidly overall in the first half of 2024,” says Stefan Dräger, Chairman of the Board of Drägerwerk Verwaltungs AG. “Demand for our Technology for Life continued unabated and net sales were almost on a par with the prior year despite the challenging comparative figures. On the earnings side, we continued to improve, making up for the shortfall in earnings from the first quarter in the second quarter.”

Continued strong demand in safety business
In the first half of 2024, the Group’s order intake increased by 0.9 percent (net of currency effects) to EUR 1,604.3 million (6 months 2023: EUR 1,596.6 million). This was due in particular to the significant growth in the Americas region and the positive development in the Germany region.

In the safety division, order intake rose by 4.1 percent (net of currency effects) to EUR 704.3 million (6 months 2023: EUR 679.1 million). Almost all product categories recorded higher demand. The biggest growth driver was our occupational health and safety equipment.

In the medical division, order intake fell by 1.5 percent (net of currency effects) to EUR 900.1 million (6 months 2023: EUR 917.5 million). This is due in particular to the significantly lower demand for ventilators, which had been supported by an extraordinary surge in demand from China in the same period of the prior year. The significant increase in order volumes for anesthesia, thermoregulation and patient monitoring devices in particular had a positive effect.

Safety business continues to grow – medical business burdened by base effects
The safety division recorded an increase in net sales of 8.8 percent (net of currency effects) to EUR 674.2 million in the first half of 2024 (6 months 2023: EUR 621.6 million), due in particular to the good order situation.

In the medical division, net sales fell by 6.5 percent (net of currency effects) to EUR 846.3 million (6 months 2023: EUR 910.7 million). This was due in particular to the China effect described above. In the same period of the prior year, the division had also benefited from catch-up effects as a result of the noticeable improvement in delivery capacity.

Earnings benefit from one-time effects
In the first half of 2024, we sold our fire alarm systems business in the Netherlands. In the 2023 fiscal year, the business field’s net sales amounted to around EUR 20 million. However, there were only a few synergies with Dräger’s core business. We have therefore exited this business. We also sold a plot of land in the USA that was not required. Overall, the one-time effects contributed around EUR 20 million to EBIT of EUR 55.8 million (6 months 2023: EUR 47.7 million).

The gross margin rose to 44.8 percent (6 months 2023: 44.0 percent) as a result of the increased share of net sales and the improved gross margin for the safety business. Our functional costs increased by 2.3 percent (net of currency effects). Earnings after taxes amounted to EUR 34.1 million (6 months 2023: EUR 28.6 million).

Business development in the second quarter
In the second quarter, order intake increased by 0.3 percent (net of currency effects) to EUR 793.5 million (Q2 2023: EUR 792.9 million). In the safety division, order intake rose by 2.0 percent (net of currency effects) to EUR 347.1 million (Q2 2023: EUR 340.7 million). In the medical division, it decreased by 1.0 percent (net of currency effects) to EUR 446.4 million (Q2 2023: EUR 452.2 million).

Dräger’s net sales increased by 2.0 percent (net of currency effects) to EUR 784.7 million (Q2 2023: EUR 771.3 million). The gross margin increased to 44.3 percent (Q2 2023: 43.1 percent). EBIT amounted to EUR 40.7 million (Q2 2023: EUR 18.7 million). The EBIT margin amounted to 5.2 percent (Q2 2023: 2.4 percent).

Annual forecast confirmed
Dräger confirms its outlook for the current fiscal year and expects net sales growth of 1.0 to 5.0 percent (net of currency effects) and an EBIT margin of 2.5 to 5.5 percent.

“Due to the continued moderate demand in the medical business, we now tend to expect net sales growth in the lower half of the forecast range. However, we have become more optimistic with regard to our profitability. We now believe that an EBIT margin in the upper half of the forecast range is more likely,” says Stefan Dräger.

Further information is available in the financial report at www.draeger.com.

Disclaimer
This press release contains statements on the future development of Dräger Group. These forward-looking statements are based on the current expectations, presumptions, and forecasts of the Executive Board as well as the information available to date. They were compiled to the best of the company’s knowledge. Dräger does not provide any warranty nor assume any responsibility for the future developments and results described above. These are dependent on a number of factors. They entail various risks and contingencies outside of the company’s influence and are based on assumptions which could prove to be incorrect. Dräger does not assume any responsibility for updating the forward-looking statements contained in this report. This does not infringe any legal stipulations on the adjustment of forecasts. Information on the financial indicators used (incl. alternative performance measures) can be found on our corporate website www.draeger.com in our Investor Relations section.
 

Press Release – Ad-hoc announcement pursuant to Art. 53 LR                          

Medacta Group SA revenues grew 14.3% at constant currency¹ in 1H 2024

• 1H 2024 revenue increased to Euro 288.6 million, or 14.3% c.c.¹ (13.1% reported) from 1H 2023;
• Strongest growth occurred in EMEA (+16.6% c.c.), with continuous progress in APAC (+12.6%) and North America (+11.1%);
• Excellent performance in Knee (+18.6% c.c.) and Shoulder (+39.6% c.c.). Solid contributions from the other business lines;
• Focus on Medical Education through scientific events hosted during 25^th Anniversary World Tour;
• Continued strengthening of the supply chain through industrial facility expansion.

CASTEL SAN PIETRO, 24 July 2024 – Medacta Group SA (“Medacta”, SIX:MOVE) announces today the first semester 2024 preliminary unaudited revenue.

In the first semester 2024 Medacta delivered robust organic growth, progressing with the acquisition of new customers across all geographies and business lines.

Francesco Siccardi, CEO of Medacta, commented: “This is a special year for Medacta. We are celebrating our 25^th Anniversary with a World Tour featuring a series of scientific events, underscoring our commitment to sustainable innovation aimed at enhancing care, outcomes, and patient well-being. The excellent performance recorded in this semester (+14.3%) is even more relevant if we consider the extraordinary growth reached in 1H 2023 (+21.4%). This result confirms, once again, our ability to continuously outperform the orthopedic market.”

The Medacta 25^th Anniversary celebration included the successful 10^th M.O.R.E. International Symposium held in Switzerland, in April, followed by a World Tour hosting a series of global scientific events in Australia and the US. These events brought together renowned experts to share knowledge with other surgeons about the sustainability of personalized medicine, and our latest technological innovations in orthopedics and spine surgery. For Knee, there has been a particular focus on Kinematic Alignment (KA), a personalized and innovative technique intended to increase patient satisfaction, together with the initial results of GMK SpheriKA, the world’s first implant specifically designed for this technique.

Supply chain remains a key factor to sustain the continued solid growth of the company and the expansion of our facilities in Switzerland is progressing as planned.

Revenue by geography

Positive performance was recorded in every market headed by strong growth in EMEA, along with continuous progress in North America and APAC. In every region the increase was sustained by a continued expansion of our salesforce and customer base, together with some new products introduction, particularly in the Knee business line through GMK SpheriKA.

Below we report the 1H 2024 sales break-down by geographic area:

* Latin America (LATAM): includes revenue from countries located in Latin America which were previously named RoW.

Revenue in EMEA grew by 16.6% c.c., to Euro 144.2 million, with significant achievements recorded in every country, and contributions from both existing and new customers.

Revenue in North America increased by 11.1% c.c. to Euro 84.9 million, thanks to a remarkable performance by the Knee and Shoulder business lines.

Revenue in Asia Pacific rose by 12.6% c.c. to Euro 54.3 million, confirmed a very good pace and a convincing execution in all business lines.

Revenue in Latin America was Euro 5.2 million with a robust increase of 22.3% c.c., driven the gain of market share in existing countries.

Revenue by product line

In terms of trend by business lines, the performance was headed by an impressive step up of Knee and Shoulder, which confirmed their excellent progress recorded in 2023. Hip and Spine are progressing with a steady growth trend.

Below we report the 1H 2024 sales break-down by product line:

* Extremities include Shoulder and Sportsmed revenues

Hip products grew by 7.5% c.c., to Euro 123.7 million, with good achievements sustained by our Anterior Minimally Invasive Surgery Approach (AMIS) and Hip revision.

Revenue from our Knee recorded an excellent performance (18.6% c.c.) to Euro 116.1 million, thanks to a solid and innovative product offering, based on our personalized kinematic alignment solutions (MyKA).

Our Extremities business line reported a sharp increase of 39.6% c.c., to Euro 24.8 million, primarily attributable to Shoulder growth in all geographies through the Medacta Shoulder System and Technologies (MyShoulder and NextAR). The Sportsmed business is progressing in the execution of its growth plan.

Revenue from our Spine offering rose by 10.0% c.c. to Euro 24.0 million, primarily driven by EMEA and by the utilization of NextAR Spine solution.

These preliminary sales figures are unaudited for the period ending June 30, 2024, and are therefore subject to change. The Group will announce its 2024 Half Year Results on September 25, 2024.

Webcast Tomorrow at 10:00 am (CEST)

Medacta Group will present its preliminary unaudited top-line figures during a webcast tomorrow at 10:00 am (CEST). The call will be headed by Francesco Siccardi (CEO) and Corrado Farsetta (CFO) and will be held in English.

Live-Link:

https://event.choruscall.com/mediaframe/webcast.html?webcastid=N67aPWqd 

Dial-in numbers for conference call function only:

CH: +41 225954728

DE: +49 6917415712

UK: +44 1 212818004

USA: +1 718 7058796

ITA: +39 02 802 09 11

Contact

Medacta

Giorgio Botta, Head of Investor Relations

Phone: +41 91 696 14 95

investor.relations@medacta.ch

 About Medacta

Medacta is a global key player specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgery. Established in 1999 in Switzerland, Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Through close collaboration with expert surgeons globally, continuous investments in R&D, and the adoption of cutting-edge technologies, Medacta’s innovation prioritizes minimally invasive surgery and personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and is present in over 60 countries. Follow us on Medacta TV, YouTube, LinkedIn and X.

 
Disclaimer

This press release has been prepared by Medacta Group SA (‘Medacta’ and together with its subsidiaries, ‘we’, ‘us’ or the ‘Group’). The information contained in the press release does not purport to be comprehensive and is not to be taken as containing any securities advice, recommendation, offer or invitation to subscribe for, purchase or redeem any securities regarding Medacta.

 Forward-looking information

This press release has been prepared by Medacta and includes forward-looking information and statements concerning the outlook for its business. These statements are based on current expectations, estimates and projections about the factors that may affect its future performance. These expectations, estimates and projections are generally identifiable by statements containing words such as ‘expects’, ‘believes’, ‘estimates’, ‘targets’, ‘plans’, ‘outlook’ or similar expressions. Although Medacta believes that its expectations reflected in any such forward-looking statement are based upon reasonable assumptions, it can give no assurance that those expectations will be achieved.

 ¹ Alternative Performance Measures

This press release contains certain information that it refers to as “constant currency” or c.c., which is a non-IFRS financial measure and represents the total change between periods excluding the effect of changes in foreign currency exchange rates. The Group believes that the reconciliations of changes in constant currency provide useful supplementary information to investors in light of fluctuations in foreign currency exchange rates. Furthermore, the Group believes that constant currency measures provide additional useful information on the Group’s operational performance and is consistent with how the business performance is measured internally. Definitions of Alternative Performance Measures and reconciliations between such measures and their IFRS counterparts may be found on the financial reports available on our website at: https://www.medacta.com/EN/financial-reports-and-presentations

Related Trademarks

Medacta Group Related Trademarks are registered at least in Switzerland. The products and services listed below may not be all-inclusive, and other Medacta products and services not listed below may be covered by one or more trademarks. The below products and services may be covered by additional trademarks not listed below. Note that Swiss trademarks may have foreign counterparts.

MyShoulder^®, NextAR™, GMK SpheriKA^®, MyKA™, AMIS^®, MySpine^®

Immunic, Inc. Strengthens Its Board of Directors with the Appointment of Experienced Pharmaceutical Executive Simona Skerjanec 

– Senior Executive and Thought Leader in Brain Health with Nearly Three Decades of Global Pharmaceutical Experience – 

– Served as Neuroimmunology Franchise Head Responsible for Roche’s Blockbuster Launch of Multiple Sclerosis Therapy Ocrevus® – 

NEW YORK, July 24, 2024 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the appointment of Simona Skerjanec, M.Pharm, MBA, a thought-leader in brain health with decades of experience in drug development and commercialization, to its board of directors, effective July 22, 2024.

Over a nearly three-decade career in the United States and internationally, Ms. Skerjanec has led research and development efforts culminating in numerous regulatory drug approvals and successful commercial launches. Most recently, Ms. Skerjanec served as Senior Vice President, Global Head Neuroscience and Rare Diseases at Roche. In this role, she led business and global corporate strategy for Roche’s portfolio of neurological and rare diseases, achieving sustainable double digit growth in sales, including with Ocrevus® (ocrelizumab)*, which remains one of the most successful medicines for the treatment of multiple sclerosis (MS). Earlier at Roche, Ms. Skerjanec served as Neuroimmunology Franchise Head, responsible for the commercial launch of Ocrevus®, generating over $1 billion in sales in the first ten months of commercialization. Prior to joining Roche, Ms. Skerjanec held positions of increasing responsibility in development and commercialization at The Medicines Company, Eli Lilly, Pfizer and Johnson & Johnson. Ms. Skerjanec also serves on the Board of Directors of Avidity Biosciences.

“We are thrilled to add someone of Simona’s exceptional caliber and expertise to our Board of Directors,” stated Duane Nash, M.D., J.D., M.B.A., Chairman of the Board of Directors of Immunic. “As the company approaches multiple late-stage readouts for vidofludimus calcium in MS over the next two years, we are determined to continue building a strong foundation for potential success. Earlier this month, we were delighted to bring on Jason Tardio, a former Novartis and Biogen executive with extensive MS drug commercialization experience, as Immunic’s new Chief Operating Officer and President. Now with Simona’s entry onto the board, we are proud to augment the company’s growing strength with a board member with such exceptional global leadership experience and who previously led one of the most successful commercial launches in MS history. Simona’s guidance will be invaluable.”

“I am very excited to join the Board of Directors of Immunic and look forward to working closely with the executive management team and the other board members,” added Ms. Skerjanec. “MS remains a devastating disease for many patients and their families. In my view, vidofludimus calcium is a particularly valuable oral drug candidate, with a highly differentiated profile and the potential to transform the treatment landscape and bring longer lasting independence to people with MS. I look forward to working with the team, and hope to help bring such an important molecule to market and achieve commercial success.”

* OCREVUS® is a trademark of Genentech, Inc. 

About Immunic, Inc. 

Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.

Cautionary Statement Regarding Forward-Looking Statements 

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding new management hires and promotions, new directors, strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; the potential for Immunic’s development programs to safely and effectively target diseases; preclinical and clinical data for Immunic’s development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; new appointments to Immunic’s board of directors; and the executive and board structure of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release. 

Contact Information

Immunic, Inc. 
Jessica Breu 
Vice President Investor Relations and Communications
+49 89 2080 477 09 
jessica.breu@imux.com 

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

US Media Contact 
KOGS Communication 
Edna Kaplan 
+1 617 974 8659 
kaplan@kogspr.com