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Biophytis Publishes First-Half Financial Results and Provides an Update on its Business Activities

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Biophytis

/ Key word(s): Half Year Results

Biophytis Publishes First-Half Financial Results and Provides an Update on its Business Activities

30-Sep-2024 / 23:00 CET/CEST

 

Biophytis Publishes First-Half Financial Results
and Provides an Update on its Business Activities

 

Paris (France) and Cambridge (Massachusetts, USA), September 30, 2024 – 11:00pm CET – Biophytis SA (Euronext Growth Paris: ALBPS) (“Biophytis” or the “Company”), a clinical-stage biotechnology company focused on developing treatments for age-related diseases, publishes today its financial results for the first half of 2024 and provides an update on the company’s key achievements.

 

Stanislas Veillet, CEO of Biophytis, commented:

 

“We are particularly pleased with the progress made in the first half of 2024. The launch of our clinical program OBA for obesity, addressing a major public health issue, and our partnership with Blanver to develop BIO101 in Latin America, are key milestones that demonstrate Biophytis’ ability to innovate and capitalize on market opportunities.

 

We are now entering a critical phase where the results of our clinical trials, especially in the obesity field, along with our continued strategy of regional pharmaceutical partnerships, particularly in Asia, could significantly transform the company’s future.

 

Despite the ongoing challenges in financial markets, the Company has been able to extend its bond financing line, and is actively working on recapitalization solutions to support its future growth.”

 

Key Highlights for the First Half of 2024:

 

Launch of a new obesity program with BIO101 (20-hydroxyecdysone): In April 2024, Biophytis announced the launch of its OBA program targeting obesity with BIO101 (20-hydroxyecdysone). The global market for obesity treatments, valued at $6 billion in 2023, is projected to reach $100 billion by 2030, with an average annual growth rate of 42%. Biophytis is positioned to capitalize on this trend with BIO101, the first oral MAS receptor activator, already recognized for its beneficial effects on muscle mass and fat mass regulation in preclinical models. A phase 2 clinical trial for the OBA program, involving 164 patients with obesity, is set to begin in the second half of 2024. Results from this pivotal study are expected by the end of 2025 and could pave the way for new therapeutic options for millions of patients struggling with obesity.

 

Exclusive Licensing Agreement with Blanver for Latin America: In June 2024, Biophytis entered into an exclusive licensing agreement with Blanver, a leading pharmaceutical player in Latin America, for the registration and commercialization of BIO101 across all its current indications: sarcopenia, obesity, COVID-19, and Duchenne muscular dystrophy. This strategic partnership could generate up to €108 million in revenue for Biophytis through milestone payments and sales-based royalties. The first phase of the agreement involves regulatory submissions in several key Latin American countries at the beginning of 2025.

 

Expansion of Financing Capabilities: During the first half of 2024, Biophytis leveraged its bond financing line with Atlas through a new issuance of €4 million. The contract, set to expire in June 2024, was renewed for two years with a total value of €16 million, allowing the Company to draw €2 million every 40 trading days. This amendment provides the Company with a bond financing facility, complementing equity financing or non-dilutive funding options.

 

 

Financial highlights :

 

 

06/30/2023

 

06/30/2024

(amounts in thousands of euros, except share data)

 

6 months

 

6 months

 

 

 

 

 

 

 

 

 

Research and development costs, net

 

(3,763)

 

           (2,105)

General and administrative expenses

 

(2,761)

 

           (2,285)

Operating income

 

(6,524)

 

         (4,390)

 

 

 

 

 

Financial expenses

 

(795)

 

           (1,545)

Financial income

 

143

 

 121

Change in fair value of convertible bonds

 

(589)

 

              (3)

Net financial income

 

(1,240)

 

           (1,427)

 

 

 

 

 

Profit before tax

 

(7,764)

 

         (5,817)

 

 

 

 

 

Income tax

 

–

 

                   –  

Net income (loss)

 

(7,764)

 

(5,817) 

 

Biophytis’ operating result shows a loss of €4.4 million as of June 30, 2024, compared to €6.5 million a year earlier. External expenses have significantly decreased, particularly in R&D activities. This change is explained by the completion of clinical trials for the COVA and SARA programs in the first half of 2023, along with substantial internalization of regulatory and clinical work associated with the launch of the OBA obesity program initiated in April 2024, as well as a global reduction in overhead expenses.

 

The financial result decreased from -€1.2 million as of June 30, 2023, to -€1.4 million as of June 30, 2024, mainly driven by expenses related to convertible and non-convertible bond borrowings with Atlas Capital and Blackrock (formerly Kreos Capital).

 

The net loss amounts to €5.7 million as of June 30, 2024, compared to €7.8 million for the same period in 2023.

 

The company’s available cash stood at €2.2 million as of June 30, 2024, compared to €5.6 million as of December 31, 2023. These resources, which include non-dilutive financing obtained during the summer totaling €0.8 million (including Bpifrance subsidies and partial pre-financing of the 2024 CIR), are expected to fund operations until the end of October 2024. Drawing a new €2 million tranche from the bond facility with Atlas Capital could extend the cash horizon until the end of 2024. This drawdown is conditional upon the outstanding debt with Atlas, which must not exceed €2 million at the time of the drawdown. It is noted that the current outstanding debt is €2.3 million.

 

Outlook and Next Steps

 

The Company will continue in 2024 and 2025 with its value creation strategy focused on the development of its therapeutic innovations.

 

Based on its financing capabilities, the Company plans to advance its drug candidate BIO101 (20-hydroxyecdysone) through proof of concept in humans, demonstrating tolerance and efficacy in a phase 2 study across two indications: obesity and Duchenne muscular dystrophy. For its sarcopenia and severe COVID-19 programs with BIO101, the Company will actively seek co-development partnerships based on the positive results already achieved in terms of efficacy and safety.

 

  • OBA Program – Development of BIO101 for Obesity

The Company plans to initiate the Phase 2 OBA study in the second half of 2024, in the United States, with potential additional centers in Europe. Preliminary results on the efficacy of BIO101 are expected by the end of 2025.

  • MYODA – Development of BIO101 for Duchenne Muscular Dystrophy (DMD)

The Company plans to start a phase 1/2 OBA study in non-ambulant DMD patients in 2025.

  • SARA (development of BIO101 in sarcopenia) and COVA (development of BIO101 in severe forms of COVID-19) programs

Over the past few years, the Company has achieved significant results in terms of efficacy, particularly in patients with sarcopenia and severe forms of COVID-19, while demonstrating good tolerance in these fragile patients. The next development steps for the SARA and COVA programs will require long and costly Phase 3 studies, for which the support of a pharmaceutical partner will be necessary through co-development and licensing agreements.

Following the agreement with Blanver in June 2024 for Latin America, Biophytis is now focusing its search for potential partners in the Asia region. Sarcopenia is a widespread condition in this region, particularly in China and Japan. In these two countries, nearly 38 million people over the age of 65 suffer from sarcopenia[1], and this population is expected to grow by over 5% per year through 2030[2], making it an especially attractive target market.

Upcoming events:

 

  • October 2, 2024: European Midcap Event – Paris
  • December 6-8, 2024: International Conference on Sarcopenia, Cachexia, and Wasting Disorders (SCWD International Conference) – Washington DC, USA

About BIOPHYTIS

Biophytis SA is a clinical-stage biotechnology company focused on developing drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular diseases (sarcopenia, Phase 3 ready to start, and Duchenne muscular dystrophy, Phase 1-2 to be started), respiratory diseases (COVID-19, Phase 2-3 completed), and metabolic disorders (obesity, Phase 2 to be started). The company is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. The Company’s ordinary shares are listed on Euronext Growth Paris (ALBPS – FR001400OLP5) and its ADS (American Depositary Shares) are listed on the OTC market (BPTSY – US 09076G401). For more information, visit www.biophytis.com.

 

 

 

 

 

 

Disclaimer

This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “trends,” “plans,” “estimates,” “anticipates,” or the negative version of these words or comparable words. These forward-looking statements are based on assumptions that Biophytis considers reasonable. However, there is no guarantee that the forward-looking statements contained in these statements will be accurate, as they are subject to various risks and uncertainties. The forward-looking statements contained in this press release are also subject to risks not yet known to Biophytis or not currently considered significant by Biophytis. Therefore, there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. Please also refer to the “Risks and Uncertainties” section of the Company’s 2023 annual financial report available on the BIOPHYTIS website (www.biophytis.com), and as outlined in the “Risk Factors” section of Form 20-F and other forms filed with the SEC (Securities and Exchange Commission, USA). We do not undertake to publicly update or revise forward-looking statements, whether as a result of new information, future developments, or otherwise, unless required by law.

 

Biophytis Contacts

 

Investor Relations

Nicolas Fellmann, Chief Financial Officer
Investors@biophytis.com

 

Media Contacts

Antoine Denry : antoine.denry@taddeo.fr – +33 6 18 07 83 27

Nizar Berrada : nizar.berrada@taddeo.fr – +33 6 38 31 90 50

 

 

 

 

 

        

 

12/31/2023

 

06/30/2024

(amounts in thousands of euros)

 

 

 

 

 

 

 

ASSETS

 

 

 

Patents and software

2,637

 

2,535  

Property, plant and equipment

315

 

 275

Property, plant and equipment – right of use

186

 

160

Other non-current financial assets

158

 

 161

Total non-current assets

3,110

 

 2,970

 

 

 

 

Other receivables

2,916

 

 3,442

Other current financial assets

368

 

113 

Cash and cash equivalents

5,567

 

 2189

Total current assets

8,850

 

 5,744

 

 

 

 

TOTAL ASSETS

11,960

 

 8,714

 

 

 

 

LIABILITIES

 

 

 

Capital

2,081

 

 4,203

Additional paid-in capital

13,483

 

 14,062

Own shares

(12)

 

                  (9)

Conversion differences

(25)

 

 (58)

Reserves – Group share

(2,357)

 

             (18,771)

Net income – Group share

(17,026)

 

           (5,812)

Shareholder equity – Group share

(3,857)

 

           (6,385)

Non-controlling interests

(32)

 

                  (33)

Total shareholder equity

(3,889)

 

             (6,418)

 

 

 

 

Staff commitments

237

 

 224

Non-current borrowing

3,247

 

 818

Total non-current liabilities

3,484

 

 1,041

 

 

 

 

Current borrowings

5,023

 

 8,838

Short-term lease liabilities

 

 

54

Provision

223

 

                    179

Trade accounts payable

5,392

 

 3,758

Tax and social security liabilities

1,348

 

 940

Current derivative liabilities

1

 

 

Other creditors and accrued liabilities

378

 

 322

Total current liabilities

12,365

 

 14,091

 

 

 

 

TOTAL LIABILITIES

11,960

 

8,714
           

 

 

 

 

06/30/2023

 

06/30/2024

(amounts in thousands of euros, except share data)

 

6 months

 

6 months

 

 

 

 

 

 

 

 

 

Revenues

 

–

 

–

Cost of sales

 

–

 

–

Gross margin

 

–

 

–

 

 

 

 

 

Research and development costs, net

 

(3,763)

 

           (2,105)

General and administrative expenses

 

(2,761)

 

           (2,285)

Operating income

 

(6,524)

 

         (4,390)

 

 

 

 

 

Financial expenses

 

(795)

 

           (1,545)

Financial income

 

143

 

 121

Change in fair value of convertible bonds

 

(589)

 

              (3)

Net financial income

 

(1,240)

 

           (1,427)

 

 

 

 

 

Profit before tax

 

(7,764)

 

         (5,817)

 

 

 

 

 

Income tax

 

–

 

                   –  

Net income (loss)

 

(7,764)

 

(5,817) 

 

 

 

 

 

Of which Group share

 

(7,764)

 

(5,812)

Of which non-controlling interests

 

–

 

(5)

 

 

 

 

 

Weighted average number of shares outstanding (excluding treasury shares)

 

818,873

 

3,499,971

Basic earnings per share (€/share)

 

(9.48)

 

(1.66)

Diluted earnings per share (€/share)

 

(9.48)

 

(1.66)

 

Note: for comparison purposes, the number of shares used to calculate earnings per share as of 06/30/2023 retrospectively takes into account the reverse stock-split of May 3, 2024 on the basis of one new share for 400 old shares

 

 

 

06/30/2023

 

06/30/2023

 

 

6 months

 

6 months

(amounts in thousands of euros)

 

 

 

 

 

 

 

 

 

Net income (loss)

 

(7,764)

 

(5,817)

Items not recyclable in the income statement

 

 

 

 

Actuarial gains and losses on post-employment benefits

 

23

 

10

Items recyclable in the income statement

 

 

 

 

Conversion difference variation

 

18

 

10

Other comprehensive income items

 

41

 

20

 

 

 

 

 

Comprehensive income (loss)

 

(7,724)

 

(5,797)

Of which Group share

 

(7,724)

 

(5,796)

Of which non-controlling interests

 

–

 

(1)

 

 

Statement of consolidated cash flows

 

 

 

06/30/2023

 

06/30/2024

 (amounts in thousands of euros)

 

 

6 months

 

 

6 months

 

 

 

 

 

 

 

Cash flow from operating activities

 

 

 

 

 

Net income (loss)

 

 

(7,764)

 

(5,817)

Elimination of depreciation on fixed assets

 

 

256

 

148

Provisions, net of reversals

 

 

(200)

 

(64)

Share-based payment costs

 

 

322

 

515

Gross interest paid

 

 

549

 

547

Change in fair value of convertible bonds

 

 

589

 

236

Discounting / undiscounting advances

 

 

12

 

 

Amortized cost of convertible and non-convertible bonds

 

 

149

 

 

Other items without cash impact

 

 

 

 

760

Cash flow from operating activities before changes in working capital

 

 

(6,086)

 

(3,674)

(+) Change in working capital (net of impairment of trade receivables and inventories)

 

 

(2,075)

 

(2,278)

(Increase) decrease in other non-current financial assets

 

 

9

 

 

(Increase) decrease in other receivables

 

 

2,018

 

122

 

 

(3,230)

 

(1,574)

            

Increase (decrease) in tax and social security liabilities

 

 

(876)

 

(735)

 

 

4

 

(91)

            

 

 

 

 

 

 

Cash flow from operating activities

 

 

(8,204)

 

(5,951)

 

 

 

 

 

 

Cash flow related to investment operations

 

 

 

 

 

Acquisition of intangible assets and property, plant and equipment

 

 

(90)

 

(9)

Subscription of term deposits classified as other current financial assets

 

 

(695)

 

 

Decrease (increase) in term deposits classified as other non-current financial assets

 

 

8

 

 

 

 

 

 

 

 

Cash flow related to investment operations

 

 

(177)

 

(9)

 

 

 

 

 

 

Cash flow related to financing operations

 

 

 

 

 

Capital increase

 

 

2,303

 

–

Expenses relating to capital increase

 

 

(339)

 

–

Exercise of ‘BSA’ warrants and ‘BSPCE’ warrants

 

 

–

 

9

Receipt of grants

 

 

–

 

–

Payment of CIR (Research tax credit) pre-financing net of deposit

 

 

1,059

 

164

Payment of repayable advances

 

 

–

 

 

Repayment of repayable advances

 

 

(165)

 

(110)

Gross interest paid

 

 

(246)

 

(547)

Issue of convertible and non-convertible bonds

 

 

1,890

 

4,000

Repayments of convertible and non-convertible bonds

 

 

(615)

 

(680)

Repayment of lease liabilities

 

 

(144)

 

(26)

Bond issue costs

 

 

(55)

 

(220)

Other cash flows related to financing operations

 

 

 

 

(8)

 

 

 

 

 

 

Cash flow related to financing operations

 

 

3,691

 

2,582

Impact of exchange rate fluctuations

 

 

(24)

 

 

Increase (decrease) in cash flow

 

 

 (5,272)

 

 (3,378)

 

 

 

 

 

 

Opening cash and cash equivalents

 

 

11,053

 

5,567

End of year cash and cash equivalents

 

 

5,782

 

2,189

 

 

 

 

 

 

 

 

 
                     

 

[1] Yuan 2023, Epidemiology of Sarcopenia, Metabolism; Shafiee 2017, Prevalence of Sarcopenia in the world, Journal of diabetes & metabolic disorders; http://dx.doi.org/10.1590/1809-9823.2015.14139

[2] Marché du traitement de la sarcopénie – Analyse des tendances et de la croissance | Année de prévision 2030 – https://www.theinsightpartners.com/fr/reports/sarcopenia-treatment-market –

Dissemination of a Financial Wire News, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.
Language: English
Issuer: Biophytis
14 avenue de l´Opéra
75001 Paris
France
Internet: https://www.biophytis.com
ISIN: US09076G1040, FR0012816825
EQS News ID: 1998991

 
End of Announcement – EQS News Service

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Xlife Sciences AG enables international co-investors to enter the stock and is planning a dual listing on the London Stock Exchange Group (LSEG)

Posted on by

Xlife Sciences AG / Key word(s): Alliance/Strategic Company Decision

30-Sep-2024 / 20:00 CET/CEST

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

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

Zurich, 30th of September 2024: The management of Xlife Sciences AG (SIX:XLS) was commissioned on September 3, 2024, after an intensive review of all available options and offers from the Board of Directors, to implement a strategy to increase market capitalization and, consequently, the stock price, as well as the liquidity and tradability of the stock.

In close coordination with new international co-investors, a dual listing on the London Stock Exchange Group (LSEG) is being developed as the first step towards implementing the value enhancement and growth strategy, and it will be executed promptly in cooperation with investment banks, funds, and market makers.

Xlife Sciences AG is confident that this will provide our valued shareholders with the greatest added value in the short term. Additionally, the company is tapping into an important, international, and continuously growing investor base, which not only enables the ambitious growth targets to be achieved but also helps align the discrepancy between market capitalization and valuation.

The Swiss Exchange (SIX Group) has already established the necessary foundation for this with the introduction of stock equivalence with the London Stock Exchange Group (LSEG).

Xlife Sciences AG would like to sincerely thank its investors for their trust and patience.

Financial calendar

Annual Report 2024 25 April 2025
Annual Shareholders Meeting 2025 24 June 2025
Half-Year Report 2025 23 September 2025

Contact 
Information for investors and journalists: Xlife Sciences AG, Dr. Dennis Fink, dennis.fink@xlifesciences.ch

Xlife Sciences AG, 
Talacker 35, 
8001 Zurich, 
Switzerland,
Phone +41 44 385 84 60
info@xlifesciences.ch, www.xlifesciences.ch, 
Commercial Register Zurich CHE-330.279.788 
Stock Exchange: SIX Swiss Exchange

End of Inside Information
Language: English
Company: Xlife Sciences AG
Talacker 35
8001 Zürich
Switzerland
Phone: +41 44 385 84 60
E-mail: info@xlifesciences.ch
Internet: www.xlifesciences.ch
ISIN: CH0461929603
Valor: A2PK6Z
Listed: SIX Swiss Exchange
EQS News ID: 1998973

 
End of Announcement EQS News Service

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Gerresheimer AG: Adjustment of growth guidance for 2024 and 2025

Posted on by

Gerresheimer AG / Key word(s): Change in Forecast/Development of Sales

Gerresheimer AG: Adjustment of growth guidance for 2024 and 2025

30-Sep-2024 / 16:21 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.

Gerresheimer AG: Adjustment of growth guidance for 2024 and 2025

 Düsseldorf, September 30, 2024 – Gerresheimer AG (ISIN: DE000A0LD6E6) is adjusting its growth guidance for 2024 and 2025 due to the significantly slower than expected market recovery 2024 and lower anticipated market growth in 2025 in the vial market. The guidance is also affected by the current flooding at the Morganton vial plant in the United States caused by Hurricane Helene, which will halt production for several weeks.

In the 2024 financial year, the company now expects organic revenue growth between 3 and 4% compared to the previous year (previously: 5 to 10%). Adjusted EBITDA is expected to be between EUR 415 million and EUR 430 million (previously: EUR 430 million to EUR 450 million). Compared to the previous year, adjusted EPS for the financial year 2024 is expected to grow between 2 and 8% (previously 8 to 12%).

For the 2025 financial year, the company now expects organic revenue growth between 7 and 10% compared to the previous year (previously 10 to 15%). The adjusted EBITDA margin for the 2025 financial year is expected to be around 22% (previously: ≥ 22%). Adjusted EPS growth for 2025 will be updated with the publication of our full-year 2024 results in February 2025.

The mid-term guidance remains unchanged.

 

End of inside information

Conference Call

Gerresheimer will hold a conference call today, September 30, 2024 at 5:30 pm CEST.
Registration Telephone Conference: https://services.choruscall.it/DiamondPassRegistration/register?confirmationNumber=2350002&linkSecurityString=5694d72a4 
Registration Webcast: https://www.webcast-eqs.com/gerresheimer-2024-09-30

Contact Gerresheimer AG

Guido Pickert
Vice President Investor Relations
T +49 211 6181-220
gerresheimer.ir@gerresheimer.com

Jutta Lorberg
Head of Corporate Communication
T +49 211 6181 264
jutta.lorberg@gerresheimer.com

End of Inside Information

30-Sep-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com

Language: English
Company: Gerresheimer AG
Klaus-Bungert-Str. 4
40468 Duesseldorf
Germany
Phone: +49-(0)211/61 81-00
Fax: +49-(0)211/61 81-121
E-mail: gerresheimer.ir@gerresheimer.com
Internet: http://www.gerresheimer.com
ISIN: DE000A0LD6E6
WKN: A0LD6E
Indices: MDAX (Aktie)
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1998771

 
End of Announcement EQS News Service

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Medacta Hosts Inaugural Capital Markets Day, Showcasing Responsible Innovation and Effective Growth Strategy

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Medacta Group SA

/ Key word(s): Miscellaneous

Medacta Hosts Inaugural Capital Markets Day, Showcasing Responsible Innovation and Effective Growth Strategy

30.09.2024 / 12:00 CET/CEST

MEDIA RELEASE

Medacta Hosts Inaugural Capital Markets Day, Showcasing Responsible Innovation and Effective Growth Strategy

CASTEL SAN PIETRO, Switzerland, September 30, 2024 – Medacta Group SA (SIX:MOVE) held its first Capital Markets Day on September 25, 2024, at its headquarters in Switzerland. The event attracted over 100 participants, both in-person and online, providing a comprehensive overview of the company’s history and patient focus, growth strategy, innovative product portfolio, and financial outlook.

“Welcoming the financial community to our headquarters has been a pleasure,” said Francesco Siccardi, CEO of Medacta. “Bringing together investors, analysts, and stakeholders in person allows us to foster deeper connections and share our vision for the future. It was a unique opportunity to share our story, our values, and our patient-focused commitment. We presented our strategic initiatives and the innovative, personalized, and minimally invasive solutions we are developing to continue to serve the surgeon community to improve patient outcomes. We value the insights and perspectives of our financial partners, and we look forward to continue collaborating with them as we drive sustainable growth and responsible innovation in the orthopedic market.”

Dr. Alberto Siccardi, Founder and President of Medacta, welcomed attendees and set the stage for the day’s presentations, sharing the story of his family as experienced entrepreneurs in the medical field and his personal story as a hip surgery patient. 

Francesco Siccardi, CEO of Medacta, highlighted the company’s strong market position and growth opportunities in key geographic areas, including the US, EMEA, Japan, and Australia. He emphasized Medacta’s commitment to continuous product development, fostered by efficient R&D activities, ongoing collaboration with surgeons, and the adoption of cutting-edge technologies, such as the MySolutions Personalized Ecosystem and NextAR, Augmented Reality Surgical Platform. 

Attendees had the opportunity to visit Medacta’s advanced production facilities, including recent expansions in Castel San Pietro and Rancate.

Medacta’s CFO, Corrado Farsetta, announced the mid-term guidance: “top line growth Compound Annual Growth Rate (CAGR) at constant currency is expected to be in the low double-digits region”, and the Adjusted EBITDA margin, he added, “targeted to be around the 2024 result, before any currency effects.” 

The CEO and the Management Team presented the innovative product portfolio and technologies across all business lines, emphasizing its focus on sustainable innovation and world-class global medical education platform, tailored to individual surgeon needs. The company’s commercial strategy centers on increasing market penetration and geographical footprint and expanding its sales force. Medacta’s product expansion strategy includes further development of its established Hip and Knee portfolio, as well as growth in Shoulder, Spine, and Sports Medicine product lines.

Moreover, participants learned more about the company’s strong commitment to corporate social responsibility and community engagement, demonstrating how Medacta strives to make a positive difference in the lives of individuals and communities worldwide. Through the Medacta for Life Foundation, Medacta supports a wide array of impactful projects that address both local and global needs.

The company has reaffirmed the importance of patients, emphasizing how they are the priority in each phase of its product development strategy.

The Capital Markets Day presentation recordings can be found here.

 

CONTACT
Medacta Group SA
Corrado Farsetta, CFO
investor.relations@medacta.ch

 

ABOUT MEDACTA
Medacta is a key global 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 operates in over 60 countries. Follow us on Medacta TV, YouTube, LinkedIn and X.

 

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. MySolutions™ Personalized Ecosystem, NextAR™.

 

Additional features:

File: MEDIA RELEASE – Medacta Hosts Inaugural Capital Markets Day Showcasing Responsible Innovation and Effective Growth Strategy

End of Media Release

Language: English
Company: Medacta Group SA
Strada Regina
6874 Castel San Pietro
Switzerland
Phone: +41 91 696 6060
E-mail: info@medacta.ch
Internet: www.medacta.com
ISIN: CH0468525222
Listed: SIX Swiss Exchange
EQS News ID: 1997593

 
End of News EQS News Service

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Modern Dental Group Shared the Technological Innovation in Dentistry Along the Development of New Quality Productive Forces in CCB International Forum

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EQS Newswire / 30/09/2024 / 15:43 UTC+8

Modern Dental Group Shared the Technological Innovation in Dentistry Along the Development of New Quality Productive Forces in CCB International Forum

 

Modern Dental Group (03600.HK) was invited to attend the investor forum with the theme of “China: Igniting New Drivers” organized by CCB International in Singapore on September 25th-27th. As a guest speaker in the panel discussion – New Quality Productive Forces in Technology and Innovation, Modern Dental shares how it uplifts the new quality productivity through its digital production cycle and accelerates growth achieved through high-tech, high-efficiency and high-quality characteristics. A total of more than 80 investors and representatives from over 60 institutions participated in the conference. The company attended the follow-up breakout sessions to meet institutional investors to further update on the company’s latest operation and development trend.

As the global leading provider of dental solutions, Modern Dental Group has achieved the milestone of restoring 2 million smiles in 2023, among more than 857,000 digital cases, with a 2-year CAGR of 66%. It is expected that the accelerated digitalization trend in dentistry will continue to drive the Group to leverage its advantages in market consolidation.

The Group is committed to providing high-quality education through interactive training, hands-on workshops, seminars and symposiums featuring industry experts. With a focus on dental community engagement, it offers exclusive networking opportunities, allowing dental professionals to connect, share experiences and foster collaborative learning.

Throughout this year, the group has built a diversified product portfolio and devoted to technological innovation in shaping a comprehensive dental ecosystem, including the integrated solution for clear aligners and facial scanning technology, intra oral scanner, AI Smile Generator in orthodontics application, Evo Fusion printed denture, SmartFit Retainer and metal surgical guide etc. As the leading player and digital innovator in the dental industry, Modern Dental Group will continue to thrive by offering cutting-edge solutions to the dental community, optimizing its digital production and management system, with the growing momentum driven by the new quality productive forces.
 

About Modern Dental Group 
 
Modern Dental Group Limited (Stock code: 03600.HK) is a leading global dental prosthetics provider, distributor and consultant with a focus on providing custom-made prostheses to customers in the growing prosthetics industry. Our product portfolio is broadly categorized into three product lines: fixed prosthetic devices, such as crowns and bridges; removable prosthetic devices, such as removable dentures; and other devices, such as orthodontic devices, sports guards, clear aligners, and anti-snoring devices.
 
Modern Dental Group has a global portfolio of respected brands, including Labocast, Permadental and Elysee Dental in Western Europe, YZJ Dental in China, Modern Dental Lab in Hong Kong, Modern Dental USA in the United States, and Southern Cross Dental in Australia. We have grown these brands by providing premium and consistent quality products and superior customer service. We have more than 80 service centers in over 23 countries and serve over 30,000 customers.

 

 

 

30/09/2024 Dissemination of a Financial Press Release, transmitted by EQS News.
The issuer is solely responsible for the content of this announcement.

Media archive at www.todayir.com

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Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM (ustekinumab-aauz)

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EQS-News: Formycon AG

/ Key word(s): Regulatory Approval/Market Launch

Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM (ustekinumab-aauz)

30.09.2024 / 07:30 CET/CEST

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

Press Release // September 30, 2024

Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM (ustekinumab-aauz)

  • OtulfiTM received FDA approval for both subcutaneous and intravenous formulations, to treat the same conditions as Stelara®
     
  • Approval represents the third successful FDA approval for a Formycon biosimilar, two of them in 2024
     
  • In accordance with the patent settlement between Formycon, Fresenius Kabi and Johnson & Johnson, Fresenius Kabi has the right to market OtulfiTM in the US no later than February 22, 2025

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Kabi jointly announce that the U.S. Food and Drug Administration (FDA) has approved FYB202/OtulfiTM1 (ustekinumab-aauz), a biosimilar to Stelara®2, for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. FYB202/ustekinumab is the third Formycon biosimilar successfully approved by the FDA.

In February 2023, Formycon and Fresenius Kabi entered into a global license agreement providing Fresenius Kabi with commercialization rights of FYB202 in key global markets, including the U.S.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “After FYB203 end of June, this marks our second FDA approval this year and we are very proud of achieving this milestone in line with our plans. Our ustekinumab biosimilar FYB202 exemplifies Formycon´s technical expertise and capabilities in developing high-quality, safe and affordable biologics. Particularly in the area of chronic inflammatory diseases, only a limited number of patients worldwide have access to biologic therapies or often have to wait for years to receive this highly effective treatment. It is important to us to improve access to biosimilars as quickly and broadly as possible.

Beyond that, FYB202 represents a key pillar of Formycon’s commercial and financial development going forward. In this context, we are very pleased with the settlement, as it allows our biosimilar to enter the market earlier than previously announced, improving our competitive positioning even further.”

Enno Spillner, CFO of Formycon AG, added: “The U.S. approval is an important step on our path to sustainable profitability, since FYB202 will contribute strongly to the financial strength of Formycon. We are pleased that with the recent approval decisions of the European Commission and the FDA, we have now successfully completed the formal approval process of FYB202 for the major markets.“

Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, said: “The FDA approval of FYB202, Fresenius Kabi’s fourth biosimilar product in the US market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the US and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally.”

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The approval 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). With global sales of more than USD 10 billion in 20233, Stelara® is one of the best-selling immunological drugs. The U.S. market accounted for the largest share of these sales at around USD 6 billion.

————————————————————————————-

 

1) OtulfiTM is a trademark of Fresenius Kabi Deutschland GmbH in selected countries

2) Stelara® is a registered trademark of Johnson & Johnson

3) https://www.investor.jnj.com/news/news-details/2024/Johnson–Johnson-Reports-Q4-and-Full-Year-2023-Results/default.aspx

 

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. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another three biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

 

About Biosimilars:

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

 

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

 

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.

 

30.09.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com

Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Germany
Phone: 089 864667 100
Fax: 089 864667 110
Internet: www.formycon.com
ISIN: DE000A1EWVY8
WKN: A1EWVY
Indices: Scale 30
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1997865

 
End of News EQS News Service

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FDA grants approval for Stelara® Biosimilar FYB202/OtulfiTM (ustekinumab-aauz)

Posted on by

Formycon AG / Key word(s): Regulatory Approval

FDA grants approval for Stelara® Biosimilar FYB202/OtulfiTM (ustekinumab-aauz)

27-Sep-2024 / 21:56 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.

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

FDA grants approval for Stelara® Biosimilar FYB202/OtulfiTM (ustekinumab-aauz)

Planegg-Martinsried, Germany, September 27, 2024 – Formycon AG (FSE: FYB, “Formycon“) announces that the U.S. Food and Drug Administration (“FDA”) today approved FYB202/OtulfiTM1 (ustekinumab-aauz), a biosimilar to Stelara®2.

FYB202/OtulfiTM obtained FDA approval for the treatment of patients with Crohn’s disease, ulcerative colitis, moderate-to-severe plaque psoriasis and active psoriatic arthritis.

The approval for FYB202/OtulfiTM is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB202/OtulfiTM demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

—————————————————————————————————————————————————————

1) OtulfiTM is a Trademark of Fresenius Kabi Deutschland GmbH in selected countries
2) 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.

 

End of Inside Information

27-Sep-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com

Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Germany
Phone: 089 864667 100
Fax: 089 864667 110
Internet: www.formycon.com
ISIN: DE000A1EWVY8
WKN: A1EWVY
Indices: Scale 30
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1997803

 
End of Announcement EQS News Service

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Original-Research: Sernova Corp (von First Berlin Equity Research GmbH)

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Original-Research: Sernova Corp – from First Berlin Equity Research GmbH

27.09.2024 / 12:41 CET/CEST
Dissemination of a Research, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this research. The result of this research does not constitute investment advice or an invitation to conclude certain stock exchange transactions.

Classification of First Berlin Equity Research GmbH to Sernova Corp

Company Name: Sernova Corp
ISIN: CA81732W1041
 
Reason for the research: Update
Recommendation: Buy
from: 27.09.2024
Target price: CAD1.90
Target price on sight of: 12 months
Last rating change: –
Analyst: Christian Orquera

First Berlin Equity Research has published a research update on Sernova Corp. (ISIN: CA81732W1041). Analyst Christian Orquera reiterated his BUY rating and decreased the price target from CAD 3.80 to CAD 1.90.

Abstract:
Sernova has presented interim data from the phase 1/2 clinical trial of its Cell Pouch for treating type 1 diabetes (T1D) at the 2024 European Association for the Study of Diabetes (EASD) Annual Meeting in Madrid, Spain. All six patients in Cohort A achieved sustained insulin independence following islet transplantation, with the first patient maintaining insulin independence for over four years before the Cell Pouch was removed due to unrelated health issues. Importantly, the removed device demonstrated safety, with no signs of fibrosis, tissue degradation, or structural changes over the long term. This makes Sernova’s Cell Pouch the only device that can harbour functioning islets (capable of producing insulin, glucagon, and somatostatin) that have remained healthy and active for more than five years after initial transplantation into the Cell Pouch. Unfortunately, there were delays in Cohort B due to immunosuppression issues in the first six patients. The company now plans to report interim results by YE 2024 following the first implantation in a recently enrolled patient and final data towards the end of Q1/25 or beginning of Q2/25; three additional patients will also be enrolled over the next few months. In addition, the company is on track to file an IND for the Cell Pouch in the indication hypothyroidism towards year-end. Following recent developments at Sernova (i.e. focus on 1G and 2G of T1D and hypothyroidism programmes, delay in closing a non-dilutive strategic deal), we have updated our SOTP valuation model and now see fair value for the share at CAD1.90 (previously CAD3.80). We maintain our Buy rating. 

First Berlin Equity Research hat ein Research Update zu Sernova Corp. (ISIN: CA81732W1041) veröffentlicht. Analyst Christian Orquera bestätigt seine BUY-Empfehlung und senkt das Kursziel von CAD 3,80 auf CAD 1,90.

Zusammenfassung:
Sernova hat auf der Jahrestagung 2024 der European Association for the Study of Diabetes (EASD) in Madrid, Spanien, Zwischenergebnisse aus der klinischen Phase 1/2-Studie mit dem Cell Pouch zur Behandlung von Typ-1-Diabetes (T1D) vorgestellt. Alle sechs Patienten in Kohorte A erreichten nach der Inseltransplantation eine dauerhafte Insulinunabhängigkeit, wobei der erste Patient mehr als vier Jahre lang insulinunabhängig blieb, bevor der Cell Pouch aufgrund nicht damit zusammenhängender gesundheitlicher Probleme entfernt wurde. Wichtig ist, dass sich das entfernte Device als sicher erwies, ohne Anzeichen von Fibrose, Gewebeabbau oder strukturellen Veränderungen über einen langen Zeitraum. Damit ist der Cell Pouch von Sernova das einzige System, das funktionierende Inseln beherbergen kann (die in der Lage sind, Insulin, Glukagon und Somatostatin zu produzieren), die mehr als fünf Jahre nach der ersten Transplantation in den Cell Pouch gesund und aktiv geblieben sind. Leider kam es in der Kohorte B aufgrund von Problemen mit der Immunsuppression bei den ersten sechs Patienten zu Verzögerungen. Das Unternehmen plant nun, nach der ersten Implantation bei einem kürzlich aufgenommenen Patienten bis Ende 2024 Zwischenergebnisse und gegen Ende des ersten oder Anfang des zweiten Quartals 2025 endgültige Daten vorzulegen; drei weitere Patienten werden in den nächsten Monaten ebenfalls aufgenommen. Darüber hinaus ist das Unternehmen auf dem besten Weg, gegen Ende des Jahres einen IND-Antrag für den Cell Pouch in der Indikation Hypothyreose zu stellen. Nach den jüngsten Entwicklungen bei Sernova (d.h. Fokussierung auf 1G und 2G der T1D- und Hypothyreose-Programme, Verzögerung beim Abschluss eines nicht verwässernden strategischen Deals) haben wir unser SOTP-Bewertungsmodell aktualisiert und sehen den fairen Wert der Aktie nun bei CAD1,90 (zuvor CAD3,80). Wir behalten unser Buy-Rating bei.

Bezüglich der Pflichtangaben gem. §85 Abs. 1 S. 1 WpHG und des Haftungsausschlusses siehe die vollständige Analyse.
 

You can download the research here: http://www.more-ir.de/d/30961.pdf

Contact for questions:
First Berlin Equity Research GmbH
Herr Gaurav Tiwari
Tel.: +49 (0)30 809 39 686
web: www.firstberlin.com
E-Mail: g.tiwari@firstberlin.com

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com

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Share price target 12.50 euros: Annual General Meeting supports SYNBIOTIC’s growth plans with over 99 percent approval

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EQS-News: SYNBIOTIC SE

/ Key word(s): AGM/EGM

Share price target 12.50 euros: Annual General Meeting supports SYNBIOTIC’s growth plans with over 99 percent approval

27.09.2024 / 11:19 CET/CEST

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

The Annual General Meeting of SYNBIOTIC SE (ISIN DE000A3E5A59 | WKN A3E5A5) has confirmed the strategic growth course of the European industrial hemp and cannabis company group with an overwhelming majority. At the virtual Annual General Meeting on Friday, 20 September 2024, the shareholders unreservedly approved the plans for the current and coming year.

The Annual General Meeting chaired by Oliver Conrad, Chairman of the Board of Directors of SYNBIOTIC, lasted just two hours. The items put to the vote received over 99 percent approval across the board. In addition to Oliver Conrad and Daniel Kruse, CEO of SYNBIOTIC, multi-entrepreneur Frank Otto, a member of SYNBIOTIC’s Board of Directors, naturally also attended the Annual General Meeting. SYNBIOTIC had once again decided to hold the Annual General Meeting virtually in order to make it easier for as many shareholders as possible to attend.

Black figures in 2025

The report by CEO Daniel Kruse, who took office at the end of August 2023, shows a clearly discernible turnaround thanks to disciplined cost optimisation, efficient synergy measures and targeted investments. Thanks to reduced costs for personnel and service providers as well as the acquisition of three strategically important companies, Kruse expects to be in the black by 2025: “Since the fourth quarter of 2023 and especially in 2024, we have seen a significant increase in demand in all business areas. These increases in turnover, coupled with cost efficiency, are expected to lead us to profitability as early as 2025.”

For the 2024 financial year, SYNBIOTIC is forecasting sales of EUR 16.6 million at Group level, with gross profit of EUR 8.4 million – and rising sales of EUR 26.2 million for 2025. This corresponds to an increase of almost EUR 10 million, i.e. an increase of 57 per cent compared to 2024. For 2026, the Group is forecasting sales revenue of EUR 33.6 million and an increase of 28 per cent.

Share price target 12.50 euros

Macroeconomic influences caused by the coronavirus pandemic and the Russian war of aggression against Ukraine, as well as arbitrary behaviour by the authorities towards hemp and CBD products, have put the economic environment for industrial hemp and cannabis products under extreme pressure. The removal of cannabis from the Narcotics Act, on the other hand, has had an extremely positive effect as expected, with sales figures for medicinal cannabis increasing many times over. However, there are also positive signals from the political arena. The entire hemp industry and of course SYNBIOTIC, thanks to its strategic positioning, will benefit greatly from the planned and now adopted (editor’s note) Industrial Hemp Liberalisation Act, or NLG for short.

These are reasons for a good share price outlook, says Daniel Kruse: “The share price is very volatile compared to other stocks. After we had a share price of less than EUR 3 at the end of 2023, it rose to almost EUR 14 at the end of March this year, particularly due to the news surrounding legalisation. The share price has currently levelled off at around EUR 6, which in the opinion of analysts, and of course also in our opinion, represents a significant undervaluation of the share. The price target until mid-2025 is around EUR 12.50 per share.” The corresponding analyst reports are available for download on the website www.SYNBIOTIC.com.

New members of the Board of Directors, new seat, new spelling

At the Annual General Meeting of SYNBIOTIC SE, Mr Malte Johannes and Mr Daniel Kruse were elected as new members of the Board of Directors. In addition, the company’s registered office was moved from Munich to Düsseldorf. Even if it is only a “cosmetic change”, the spelling of the company has been changed from SynBiotic to SYNBIOTIC in capital letters.

Diversity advantage

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

Publisher
SYNBIOTIC SE
Daniel Kruse
Managing Director
Münsterstraße 336
40470 Düsseldorf
Germany

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

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

27.09.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com

Language: English
Company: SYNBIOTIC SE
Münsterstr. 336
40470 Dusseldorf
Germany
E-mail: office@synbiotic.com
Internet: https://www.synbiotic.com/
ISIN: DE000A3E5A59
WKN: A3E5A5
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt, Munich, Tradegate Exchange
EQS News ID: 1997475

 
End of News EQS News Service

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Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi® (ustekinumab) for the treatment of serious inflammatory diseases

Posted on by

EQS-News: Formycon AG

/ Key word(s): Regulatory Approval/Miscellaneous

Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi® (ustekinumab) for the treatment of serious inflammatory diseases

27.09.2024 / 09:00 CET/CEST

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

Press Release // September 27, 2024

Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi® (ustekinumab) for the treatment of serious inflammatory diseases

  • FYB202/Otulfi® received European Commission (EC) approval for both subcutaneous and intravenous formulations, providing a high-quality treatment option for European patients treated with ustekinumab
     
  • FYB202/Otulfi® is approved in the indications of moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Kabi jointly announce that the European Commission (EC) has issued a marketing authorization for FYB202/Otulfi®1, a biosimilar to Stelara®2. The centralized marketing authorization is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway.

Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. The European Commission’s decision to issue a marketing authorization came after the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency’s (EMA) adopted a positive opinion in July 2024 to approve FYB202/Otulfi® in the indications of moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis. The EC decision 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).

In February 2023, Formycon and Fresenius Kabi entered into a global license agreement providing Fresenius Kabi with commercialization rights for FYB202 in key global markets. Semi-exclusive commercialization rights that cover Germany, parts of the MENA region and Latin America remain with Formycon. In March 2024, Formycon and Fresenius Kabi reached a settlement agreement with Johnson & Johnson concerning the commercialization of their ustekinumab biosimilar in Europe and Canada. The terms of the agreement are confidential. Stelara® ranks among Europe’s top-10 medicine brands by value with annual sales in Europe in excess of €2.5 billion.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “FYB202/ustekinumab is our second biosimilar with market approval in Europe, and this marks another very important step on our way to a leading, profitable and sustainable pure-play biosimilar company. Chronic inflammatory diseases are globally on the rise and negatively impact the quality of life of millions of people. This especially relates to Europe, which has the highest prevalence of psoriatic diseases in the world.3 With FYB202/Otulfi® we are – together with our partner Fresenius Kabi – committed to providing a safe, effective and cost-efficient treatment option for this large number of patients.”

Dr. Sang-Jin Pak, President Biopharma and member of the Fresenius Kabi Management Board, said: “With the approval of Otulfi® in Europe, we expand our biosimilar portfolio with the fourth biosimilar to better support patients’ treatment experience and clinical outcomes. Our ustekinumab biosimilar is a testament to our dedication and commitment to patients across Europe, and we are proud to continue to deliver high-quality and affordable therapies for autoimmune diseases, while striving to ease the burden on local healthcare systems.”

1) Otulfi® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
2) Stelara® is a registered trademark of Johnson & Johnson
3)) https://cms.ifpa-pso.com/tools/20072022_IFPA-FORUM_Briefing-Book_Speaking-up.pdf

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. FYB203/aflibercept-mrbb received FDA approval, and FYB202/ustekinumab was approved in Europe. Another three biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

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

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

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.

 

27.09.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
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Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Germany
Phone: 089 864667 100
Fax: 089 864667 110
Internet: www.formycon.com
ISIN: DE000A1EWVY8
WKN: A1EWVY
Indices: Scale 30
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1996625

 
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