Frauenfeld, 15 October 2024

Press release

DocMorris accelerates Rx growth

• Rx revenue growth of 12.2 per cent in the third quarter
• Acceleration to over 25 per cent in the last few weeks
• Strong increase in new Rx customers
• OTC growth of 1.9 per cent
• Pablo Ros Gomez becomes new CTO
• Closure of the logistics site in Halle (DE)

DocMorris’ e-prescription business continues to gain momentum: In the third quarter of 2024, external revenue^[1] of prescription medicines (Rx) in Germany grew by 12.2 per cent in local currency compared to the previous year and by 15.5 per cent compared to the second quarter of 2024. A strong upward trend is visible, with growth of over 25 per cent in recent weeks compared to the previous year. The expected decline in revenue of paper prescriptions is more than compensated by the positive development of e-prescriptions. In the base business, where profitability is the priority, sales of over-the-counter (OTC) medicines rose as planned in the third quarter, increasing by 1.9 per cent in local currency compared to the previous year.

The dynamic development in the Rx business shows that customers greatly appreciate the simple prescription redemption via the DocMorris app and next working day delivery. This is also reflected in the strong growth in the number of new Rx customers. Repeat order rates and average order values continue to develop favourably. Against this backdrop, DocMorris has intensified its customer acquisition activities since mid-September as announced.

TeleClinic, an important pillar in the DocMorris health ecosystem, continued its strong growth in the third quarter and once again doubled its revenue compared to the same period last year.

In the Europe segment, which focuses on Spain, France and Portugal, revenue in the third quarter rose by 7.4 per cent in local currency compared to the previous year.

External revenue for the entire Group grew by 4.9 per cent in local currency and 3.8 per cent in Group currency to CHF 265.7 million in the third quarter compared to the previous year. At the end of September, the number of active customers^[2] increased by 200,000 to 10.2 million compared to the previous quarter.

Pablo Ros Gomez becomes new CTO
After more than three years, CTO Madhu Nutakki has decided to leave the company to return to the USA. He has made a significant contribution to the successful establishment of the DocMorris technology and data platform. The Board of Directors and Executive Board would like to thank him for his valuable contribution and wish him all the best for the future.

Pablo Ros Gomez will take over as CTO and member of the Executive Board from 1 November 2024. He is already responsible for the company-wide Technology, Product and IT Operations/Infrastructure division and has been CTO of the Europe segment for many years and is thus well prepared for his new role.

Step towards increasing efficiency: closure of the Zur Rose Pharma logistics site in Halle, DE
In future, online customers of the Zur Rose pharmacy will be supplied with over-the-counter and prescription medicines on request by the DocMorris pharmacy from the logistics centre in Heerlen. In agreement with the owner of the Zur Rose pharmacy in Halle (Saale), DocMorris will close its Zur Rose Pharma GmbH service location on 31 December 2024. The “Zur Rose” brand will be discontinued.

Outlook
DocMorris confirms the targets for 2024 communicated in August:

• Increase in external revenue by 5 to 10 per cent, including e-prescriptions
• Adjusted EBITDA of around minus CHF 50 million, including e-prescriptions
• Capital expenditure of around CHF 30 million

 

Revenue, in CHF million (unaudited)	1.7.-30.9.2024	1.7.-30.9.2023	Change
Continuing operations (excl. Swiss business)
DocMorris external revenue	265.7	256.0	3.8%
DocMorris external revenue in local currency			4.9%
DocMorris	248.4	241.2	3.0%
DocMorris in local currency			4.1%
Markets
Germany external revenue	250.3	241.6	3.6%
Germany external revenue in local currency			4.8%
Germany external revenue Rx	48.1	43.3	11.2%
Germany external revenue Rx in local currency			12.2%
Germany external revenue OTC	197.5	196.2	0.7%
Germany external revenue OTC in local currency			1.9%
Germany	233.0	226.7	2.8%
Germany in local currency			4.0%
Europe	15.4	14.5	6.3%
Europe in local currency			7.4%

 

Revenue, in CHF million (unaudited)	1.1.-30.9.2024	1.1.-30.9.2023	Change
Continuing operations (excl. Swiss business)
DocMorris external revenue	795.8	757.5	5.1%
DocMorris external revenue in local currency			7.2%
DocMorris	744.7	704.2	5.8%
DocMorris in local currency			7.9%
Markets
Germany external revenue	748.0	710.1	5.3%
Germany external revenue in local currency			7.5%
Germany external revenue Rx	126.2	132.8	-5.0%
Germany external revenue Rx in local currency			-3.1%
Germany external revenue OTC	609.8	571.8	6.6%
Germany external revenue OTC in local currency			8.8%
Germany	696.9	656.7	6.1%
Germany in local currency			8.3%
Europe	47.7	47.4	0.7%
Europe in local currency			2.7%

 

Investors and analyst contact
Dr. Daniel Grigat, Head of Investor Relations & Sustainability
Email: ir@docmorris.com, phone: +41 52 560 58 10

Media contact
Torben Bonnke, Director Communications
Email: media@docmorris.com, phone: +49 171 864 888 1

Agenda

21 January 2025	Sales 2024
13 March 2025	2024 Full-year results and outlook 2025 (conference call/webcast)
17 April 2025	Q1/2025 Trading Update
8 May 2025	Annual General Meeting, Zurich
19 August 2025	2025 Half-year results (conference call/webcast)
16 October 2025	Q3/2025 Trading Update

 

DocMorris
The Swiss-based DocMorris AG is a leading company in the fields of online pharmacy, marketplace and professional healthcare with strong brands in Germany and other European countries. Deliveries are mainly from the highly automated logistics centre in Heerlen, the Netherlands, with a capacity of over 27 million parcels per year. In Spain and France, the company operates the leading marketplace for health and personal care products in Southern Europe. With its business model, DocMorris offers its patients, customers and partners a broad range of products and services. In doing so, DocMorris is pursuing its vision of creating a digital health ecosystem for everyone to manage their health in one click. The company was renamed from Zur Rose Group AG to DocMorris AG in May 2023 after the Swiss business was sold to Migros/Medbase. Excluding the Swiss business, about 1,600 employees in Germany, the Netherlands, Spain, France and Switzerland generated an external revenue of CHF 1,038 million serving currently 10 million active customers. The shares of DocMorris AG are listed on the SIX Swiss Exchange (securities number 4261528, ISIN CH0042615283, ticker DOCM). For further information, please visit corporate.docmorris.com.

 

 

 

^[1]  External revenue consists of the consolidated revenue of DocMorris plus online revenues of pharmacies supplied by DocMorris, less the consolidated revenue from supplying them.

^[2]  Customers supplied by DocMorris, either directly or through its partners

Solar power for Gerresheimer site in Momignies, Belgium

• 2.3 MWp rooftop photovoltaic system on production building
• Gerresheimer increases share of green electricity in its energy supply
• Goal for 2030: 100% electricity from renewable sources

Duesseldorf/Momignies, October 14, 2024. Gerresheimer, an innovative system and solution partner and a global partner for the pharma, biotech and cosmetic industries has successfully installed a photovoltaic system at its site in Momignies, Belgium. Gerresheimer produces glass flacons and jars for the cosmetics industry with its roughly 750 employees in Momignies. With an installed capacity of 2.3 MWp, it will produce around 2,100 MWh of solar power each year and is expected to save roughly 300 tons of CO₂ compared to sourcing conventional electricity in Belgium. Almost 100% of the electricity generated will be used on site. Installing PV systems on suitable rooftops like at the Momignies site and concluding power purchase agreements with wind and solar park operators are key steps to helping Gerresheimer continually increase the share of green electricity in its energy supply. Gerresheimer has set ambitious sustainability goals as part of its formula g corporate strategy. By 2030, the company aims to switch its entire electricity supply to renewable sources.

“The photovoltaic system in Momignies is a great example of how we are gradually advancing our sustainability goals,” explains Dietmar Siemssen, CEO of Gerresheimer AG. “We are increasing the share of green energy in the electricity supply to our production sites while reducing our CO₂ emissions in the process. Gerresheimer also benefits economically from these projects.”

Almost 100% of electricity generated used on site
The new photovoltaic system at the Momignies site covers over 15,000 m² on the roof of a production hall – the equivalent of around two soccer fields. Almost 100% of the green electricity produced by the PV system is used on site. Only any peak loads are fed into the public grid. Expansion to other areas is already being considered.

By the end of 2024, the share of electricity from renewable sources at the Momignies site will increase to around 25%, including the energy produced by the new PV system. Due to its energy-intensive glass production, the site in Momignies is one of the Gerresheimer sites with high energy demand. The total share of energy from renewable sources across all 35 production sites around the globe had already reached 45.6% by the end of 2023.

High-quality and sustainable glass packaging for the cosmetics industry
The Gerresheimer site in Momignies, Belgium, specializes in the production and decoration of glass flacons and jars as primary packaging for perfume, skin and body care products. Gerresheimer uses up to 40% post-consumer recycled glass (PCR) to produce these products. Using PCR conserves resources and reduces energy consumption in the production of high-quality primary packaging solutions.

Transparent sustainability reporting
In addition to publishing a sustainability report every year, Gerresheimer also discloses relevant data as part of the ratings issued by CDP, EcoVadis, and other organizations. MSCI, Sustainalytics and ISS also evaluate Gerresheimer’s sustainability performance An overview of Gerresheimer’s external sustainability ratings can be found here.

 

About Gerresheimer 
Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, dropper bottles, other bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. With around 12,000 employees, the company generated revenues of around €2bn in 2023. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).  
www.gerresheimer.com 

Contact Gerresheimer AG 

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

Marion Stolzenwald
Senior Manager Corporate Communication
P +49 1722424185
marion.stolzenwald@gerresheimer.com

 

Korneuburg, Austria, 11. October 2024 – Marinomed Biotech AG (the “Company”) announces that, after a thorough review of existing offers, the Management Board today decided to enter contract negotiations for the sale of the Carragelose portfolio in the form of an asset deal. The Company selected the potential buyer based on a combination of favorable purchase price, transaction security and strategic fit, thereby providing a long-term perspective for the Company. The actual implementation of the transaction depends on the outcome of the specific negotiations, the conclusion of the respective transaction documents, the approval of the Supervisory Board and the General Shareholder Assembly, as well as the continuation of the Company after the restructuring process. In addition, due to the ongoing restructuring process, approvals from the insolvency administrator and the insolvency court are necessary. These approvals have not yet been obtained.

+++ End of ad-hoc announcement +++

Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Australia, Canada or Japan or any other jurisdiction in which such release, publication or distribution would be unlawful. The important notes at the end of this announcement need to be observed.

 

The medical cannabis market is booming: Cantourage Group SE reports record quarter in third quarter of 2024

• Sales revenue of EUR 13.2 million in the period from July 1 to September 30, 2024 (Q3) (same period of the previous year: EUR 5.9 million), a year-on-year increase of 130 %
• Profitable growth is stabilizing: EBITDA of between EUR 0.9 million and EUR 1.1 million in the third quarter of 2024
• Revenue of at least EUR 40 million expected for the full year 2024

Berlin, October 10, 2024 – Cantourage Group SE (hereinafter referred to as “Cantourage,” ISIN: DE000A3DSV01, www.cantourage.com), Europe’s leading publicly listed cannabis company, generated revenue of EUR 13.2 million in the period from July 1 to September 30, 2024, setting a new record quarter in the company’s history. Last month, the company announced that it had exceeded its total annual revenue for 2023 (EUR 23.6 million) in the period from January 1 to August 30, 2024, by posting revenue of EUR 24.9 million. Yet another positive EBITDA in the range of EUR 0.9 million to EUR 1.1 million in the third quarter of 2024 shows that Cantourage is able to convert the current developments in the European medical cannabis markets into sustainable, profitable growth. Revenue of at least EUR 40 million is expected for the full year 2024.

“It is important for investors to realize that the only areas in Germany and Europe in which truly profitable and growing business models can be established and monetized are those related to medical cannabis. I am not aware of any German company that is growing significantly and operating profitably with seeds, cuttings and non-commercial association structures,” said Philip Schetter, CEO of Cantourage.

Cantourage thus confirms the positive business development since the partial legalization of cannabis on April 1, 2024, although legalization for recreational use in Germany faces serious challenges. The cultivation associations (“cannabis clubs”) are facing massive bureaucratic headwinds, with the result that only very few of them have been able to start operations to date – and the future prospects are more than questionable. The so-called “Pillar 2” of the Cannabis Act, which was intended to lay the foundation for a real recreational market, was recently buried for the current legislative period even by the biggest legalization advocates in the federal government.

As unclear as the situation in the recreational sector is, the medical cannabis market in Germany is currently growing steadily. On April 1, 2024, cannabis was also removed from the Narcotics Act in a therapeutic context, which massively simplifies the process for everyone involved – from importers to doctors and pharmacies to patients. This has led to an unprecedented demand for medical cannabis, which Cantourage brings to Europe from many cultivation companies worldwide.

“The real legalization of recreational cannabis that contains THC, as is the case in North America, for example, is off the table here for the time being. Nevertheless, medical cannabis is here to stay and will continue to grow.
We are pleased that so many people in Germany have found their way to cannabis therapy in the past few months. This development will definitely continue in the future. Millions of cannabis users who have so far treated themselves for sleep disorders, pain or other widespread diseases – and have often resorted to unsafe products from the black market for this purpose – can now access safe preparations in pharmaceutical quality. We deliver these products through our flexible and efficient sourcing model, which we can and will continue to scale up in the months ahead. One thing is clear to us: regardless of what happens in the recreational market, the medical market will play the leading role in the years to come in ensuring that people in Germany and other European countries have access to safe, tested cannabis,” emphasizes Philip Schetter, CEO of Cantourage.

 

About Cantourage

Cantourage is a leading European producer and distributor of cannabis flowers and cannabis-based medicinal preparations and drugs. The Berlin-based company was founded in 2019 by industry pioneers Norman Ruchholtz, Dr. Florian Holzapfel and Patrick Hoffmann. With an experienced management team and its “Fast Track Access” platform, Cantourage enables producers from around the world to become part of the growing European medical cannabis market faster, easier and more cost-effectively by processing and distributing their cannabis raw materials and extracts. In this context, Cantourage ensures compliance with the highest European pharmaceutical quality standards at all times. The company offers pharmaceutical-grade products in all relevant market segments: dried flower, extracts, dronabinol and cannabidiol. Cantourage was listed on the Frankfurt Stock Exchange on 11 November 2022 and is listed under ticker symbol “HIGH.”

Further information: www.cantourage.com

 

This announcement does not constitute a public offer or an advertisement for a public offer to sell securities, in particular not within the meaning of Regulation (EU) 2017/1129 (Prospectus Regulation).

 

Press contact at Cantourage:

Frederick Steudemann
Tel. +49 (0)30 4701 350 – 50
steudemann@cantourage.com

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

• HDP-101 clinical trial in Europe and US continues with adjusted protocol and dose optimization on track; sixth patient cohort dosed at 90 µg/kg and patients are still on treatment
• Sale of a portion of future royalties for TLX250-CDx to HealthCare Royalty
• New clinical data with HDP-101 presented at the International Myeloma Society (IMS) Annual meeting; one patient in complete remission
• Two R&D webinars with Key Opinion Leaders planned for October
• Guidance adjusted

Ladenburg, Germany, 10 October 2024 – Heidelberg Pharma AG (FSE: HPHA) reported today on its operational progress as well as on the Group’s financial figures for the first nine months of fiscal year 2024 (1 December 2023 – 31 August 2024).

Professor Andreas Pahl, CEO of Heidelberg Pharma AG, commented: “Our development activities are on track. The patients in the sixth cohort of our clinical study with HDP-101 are currently still undergoing treatment, and we expect to complete the cohort in the next few weeks.

We are very pleased to have presented new clinical results from the fifth cohort at the renowned International Myeloma Society Annual Meeting. We see a complete remission with a full elimination of tumor cells in one of our heavily pretreated patients. This success confirms the potential of HPD-101 as a treatment option for multiple myeloma patients.

In October, we adjusted the guidance for our financial figures. This is due to significantly lower R&D costs than planned and higher revenue in 2024.”

Important operational developments and achievements

• HDP-101 development program: HDP-101, an Antibody Targeted Amanitin Conjugate directed against the antigen BCMA, is being tested in a Phase I/IIa open-label, multicenter study for the treatment of relapsed or refractory multiple myeloma, a cancer of the bone marrow. The first part of the study is a Phase I dose escalation study to find the safe and optimal dosing of HDP-101 for the Phase IIa portion of the study. The first four patient cohorts and dose levels were completed with no evidence of dose limiting toxicities.

  In the fifth cohort, all patients at a dose of 100 µg/kg HDP-101 experienced a drop in thrombocyte count, which completely normalized after a few days and was clinically unremarkable. To mitigate this transient effect, the clinical team adjusted and optimized the medication regimen. Cohort 6 consists of three arms, with at least three patients enrolled in each arm. In consultation with the clinical investigators, the dose will be 90 µg/kg in order to test these three dosing regimens with as little risk to the patients as possible.

  Patients in Arm A will be treated with a single dose of HDP-101 on day 1 of each 21-day cycle following pre-medication. Arm B will receive a weekly dose of HDP-101, which means that the dose will be split, and patients will be treated proportionally on days 1, 8 and 15 of each cycle. Arm C receives a partial dose of HDP-101 on days 1 and 8 of the first cycle and then a single dose on day 1 of each of the following 21-day cycles. Patients are currently still being treated in the sixth cohort, which is expected to be completed in the next few weeks.
   

• HDP-102 development program: HDP-102 is an ATAC targeting CD37, which is overexpressed on B-cell lymphoma cells. Preclinical studies have shown excellent anti-tumor efficacy in in vivo studies as well as good tolerability. Heidelberg Pharma intends to develop HDP-102 for specific indications of non-Hodgkin lymphoma (NHL).

  All productions steps for HDP-102 have been completed and all necessary preclinical and toxicological studies have been conducted. The data package required for the clinical trial application will be finalized in Q4 of this year. As a first step, the application will be submitted to the regulatory authority in a non-EU European country, followed by a central submission to the EMA.
   

• HDP-201 development program: Since fall 2023, the company has been developing further ADC projects with other payloads. The first candidate of the second platform is HDP-201, an exatecan-based ADC. Exatecan is a topoisomerase I inhibitor that has proven itself in cancer therapy and is used in two already approved ADCs. Its mode of action differs from that of Amanitin, and thus expands the company’s range of active ingredients.

  HDP-201 targets guanylyl cyclase-C (GCC), a receptor that is expressed on the surface of intestinal cells and cancer cells in various gastrointestinal tumors. Preclinical results show that the tolerability and efficacy of HDP-201 is at least comparable to already approved exatecan ADCs.

  Based on extensive preclinical efficacy and tolerability testing, the final development candidate for HDP-201 was selected and the indication determined in recent weeks. HDP-201 is to be developed for the treatment of colorectal cancer.
   

• Agreement concluded on the partial sale of license fees to HealthCare Royalty: In early March 2024, Heidelberg Pharma signed an agreement with HealthCare Royalty, Delaware, USA, (HCRx) for the sale of a portion of future royalties from global sales of TLX250-CDx. Heidelberg Pharma received an upfront payment of USD 25 million and is also entitled to receive up to an additional USD 90 million from the sale of royalties if defined milestones are reached. After HCRx has received a maximum cumulative amount, the royalties will revert to Heidelberg Pharma, and HCRx will receive a low single-digit percentage of Heidelberg Pharma’s royalties.

Update on partner programs outside ATAC technology

• Progress at partner Telix: TLX250-CDx is a radiolabeled form of the antibody girentuximab, which binds to the tumor-specific antigen CAIX on clear cell renal cell carcinoma (ccRCC) and possibly other tumor types. Accumulation of this antibody in tumor tissue can be visualized by positron emission tomography (PET) scans. This could fundamentally change therapy planning for renal cancer patients and avoid potentially unnecessary surgery. The diagnostic agent may also prove suitable for monitoring treatment response, detecting metastases, and diagnosing other kinds of tumors.

  The antibody was developed at Heidelberg Pharma AG up to a first Phase III trial and outlicensed to the Australian company Telix in 2017.

  Telix had successfully completed a second Phase III trial and, based on these positive Phase III results, completed the submission of a rolling New Drug Application in the United States in June 2024. The company announced at the end of July that the FDA had not accepted the application for approval at that time because of a manufacturing issue. Evidence of adequate sterility assurance during filling of the substance must be provided. Telix plans to resubmit the revised application in the fourth quarter of this year. The application for priority review remains unchanged.

Events after the end of the reporting period

• New clinical data on HDP-101 presented at International Myeloma Society Annual Meeting 2024: At the 21st International Myeloma Society (IMS) Annual Meeting held in Rio de Janeiro, Brazil, at the end of September, Professor Marc-Steffen Raab, Head of the Myeloma Center at the University Hospital Heidelberg and clinical investigator of the study, presented new clinical findings from five patient cohorts of the trial with the BCMA-targeting ATAC HDP-101. Clinical data from the fifth cohort demonstrated complete remission in one patient who had been heavily pre-treated. This patient showed an objective improvement (“partial response”) in the 2nd cycle of treatment and complete remission was confirmed after the 11th cycle.
   
• R&D webinars planned: Heidelberg Pharma will host a webinar on 15 October 2024, focusing on the presentation of clinical data from the HDP-101 trial to date. Another webinar, scheduled for 29 October 2024, will go into more detail on the importance of ADCs in cancer therapy. The data presented will be shared by Heidelberg Pharma’s management team and key opinion leaders (KOLs) in the myeloma field. Both events are open to investors, analysts, journalists and other interested parties.

Results of operations, financial position and net assets

The Heidelberg Pharma Group, consisting of Heidelberg Pharma AG and its subsidiary Heidelberg Pharma Research GmbH reports consolidated figures as at the balance sheet date. The reporting period referred to below relates to the period from 1 December 2023 to 31 August 2024 (9M 2024).

In the first nine months of the 2024 business year, the Group generated sales revenues and income totaling EUR 7.6 million (previous year: EUR 13.9 million) and is in line with the updated planning. The sales revenues included in this figure fell from EUR 6.6 million the previous year to EUR 5.2 million. Other income amounted to EUR 2.4 million and was therefore significantly lower than the previous year’s level of EUR 7.3 million due to the unscheduled sale of the Emergence stake.

Operating expenses, including depreciation, amounted to EUR 22.8 million in the reporting period (previous year: EUR 30.0 million) and are broken down as follows: Cost of sales decreased to EUR 1.5 million (previous year: EUR 3.1 million) and correspond to 7% of total costs. Research and development costs of EUR 15.7 million decreased compared to the same period last year (EUR 22.1 million). In the 2024 financial year, fewer costs have been incurred for the Phase I/IIa trial than originally planned. Some of the projected expenses for this will be incurred in the further course of the study in the next financial year. R&D costs continue to be the largest cost block, accounting for 68% of operating expenses. Administrative costs, which include the costs of holding activities, the stock exchange listing and the executive management board, increased to EUR 4.7 million compared to the same period last year (EUR 3.6 million), which is due to higher personnel costs including stock options issued. Administrative costs account for 21% of operating expenses. Other expenses for business development, marketing and commercial market supply activities, which mainly include personnel and travel expenses, decreased year-on-year to EUR 1.0 million (previous year EUR 1.2 million) and represented 4% of operating expenses.

The financial result, which is mainly made up of interest income on bank balances, amounted to EUR 1.0 million (previous year: EUR 0.5 million). The significant improvement is due to the now complete repayment of the shareholder loan, as well as interest income from a higher investment volume.

The net loss for the first nine months of the financial year decreased to EUR 14.3 million compared to the previous year’s figure of EUR 15.8 million. Despite lower sales revenues, the improvement is mainly due to lower expenses. Earnings per share improved accordingly from EUR -0.34 in the previous year to EUR-0.31 in the reporting period.

Cash amounted to EUR 36.6 million at the end of the third quarter (30 November 2023: EUR 43.3 million; 31 August 2023: EUR 50.7 million). Excluding financing effects (shareholder loans, sale of receivables), Heidelberg Pharma recorded an average cash outflow of EUR 2.6 million per month in the first nine months of the fiscal year (previous year: EUR 2.3 million).

Total assets as of 31 August 2024 amounted to EUR 65.8 million and were therefore below the figure as at the comparative reporting date of 30 November 2023 (EUR 70.4 million). Equity (EUR 35.8 million) also decreased as a result of the loss for the period compared to the end of the 2023 financial year (EUR 49.3 million).

Financial outlook for 2024

The guidance issued in June 2024 for the current financial year was adjusted downwards on the cost side and upwards on the revenue side on 1 October 2024.

For the financial year 2024, the Heidelberg Pharma Group expects sales and other income between EUR 10.0 million and EUR 12.0 million (previously: EUR 9.0 million to EUR 12.0 million). Operating expenses are expected to fall within a range of EUR 30.0 million and EUR 33.0 million (previously: EUR 36.0 million to EUR 40.0 million). In the 2024 financial year, fewer costs have been incurred for the Phase I/IIa trial than originally planned. Some projected expenses for this trial will be incurred in the further course of the study in the next financial year. Based on these adjustments, an operating result (EBIT) between EUR -19.0 million and EUR-22.0 million is expected (previously: EUR -25.5 million to EUR -29.5 million).

For 2024, Heidelberg Pharma anticipates cash requirements of EUR 13.0 million to EUR 16.5 million (previously: EUR 18.0 million to EUR 22.0 million). Monthly cash consumption is expected to range between EUR 1.1 million and EUR 1.4 million per month (previously: EUR 1.5 million and EUR 1.8 million). Based on the existing planning and available funds, the company’s financing remains secured until mid-2025.

Taking into account a further expected payment of USD 75.0 million from HealthCare Royalty following approval of TLX250-CDx, the company anticipates a financial reach until the end of 2026, based on current medium-term planning.

The complete set of figures for the interim financial statements is available at http://www.heidelberg-pharma.com/ “Press & Investors > Announcements and Reports > Financial Reports > Interim announcement of 10 October 2024. A conference call on this interim announcement will not be offered.

Key figures for the Heidelberg Pharma Group

In EUR thsd.	9M 2024 1 EUR thsd.	9M 2023 1 EUR thsd.
Earnings
Sales revenue	5,248	6,635
Other income	2,368	7,259
Operating expenses	(22,849)	(29,985)
of which research and development costs	(15,650)	(22,065)
Operating result	(15,233)	(16,091)
Earnings before tax	(14,259)	(15,561)
Net loss for the period	(14,259)	(15,838)
Basic earnings per share in EUR	(0.31)	(0.34)
Balance sheet as of the end of the period
Total assets	65,775	74,328
Cash	36,569	50,675
Equity	35,823	51,488
Equity ratio2 in %	54.5	69.3
Cash flow statement
Cash flow from operating activities	(22,749)	(26,494)
Cash flow from investing activities	(266)	5,871
Cash flow from financing activities	16,106	(10,024)
Employees (number)
Employees as of the end of the period3	109	111
Full-time equivalents as of the end of the period3	98	101

1 The reporting period begins on 1 December and ends on 31 August.
2 Equity / total assets
3 Including members of the Executive Management Board
Rounding of exact figures may result in differences.

 

Contact Heidelberg Pharma AG Sylvia Wimmer Director Corporate Communications Tel.: +49 89 41 31 38 29 Email: investors@hdpharma.com Gregor-Mendel-Str. 22, 68526 Ladenburg

IR/PR support MC Services AG Katja Arnold (CIRO) Managing Director & Partner Tel.: +49 89 210 228 40 Email: katja.arnold@mc-services.eu

 

About Heidelberg Pharma

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

Heidelberg Pharma is the first company to use the mushroom toxin Amanitin in cancer therapies by exploiting the toxin’s biological mechanism of action with its innovative ATAC technology as a new therapeutic modality. It offers the opportunity to not only overcome resistance of cancer cells against therapeutic agents currently used, but also has the ability to eliminate dormant tumor cells. This could lead to significant advances in cancer therapy – even for patients who no longer respond to any other treatment. The most advanced product candidate HDP-101 is an BCMA-ATAC for the indication multiple myeloma, which is currently in clinical development.

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

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

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

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

Ad hoc announcement pursuant to Art. 53 LR

Fribourg, 8 October 2024

AEVIS VICTORIA SA (AEVS.SW) – Swiss Medical Network strengthens its presence in Ticino with the acquisition of «Centromedico»

Swiss Medical Network, the operating subsidiary of AEVIS VICTORIA SA dedicated to healthcare, is acquiring PDS Medical SA, which operates 10 group practices in the Canton of Ticino under the brand name «Centromedico» and thus provides a significant proportion of primary medical care for the population of Ticino. PDS Medical SA recorded revenues of approximately CHF 42 million in 2023. The parties have agreed not to disclose the purchase price.

With this acquisition, Swiss Medical Network strengthens its position in the canton of Ticino and lays the foundation for a second integrated care region in Switzerland under the name «Rete Sant’Anna». Based on the model of the Réseau de l’Arc in the Bernese Jura, where Switzerland’s first fully integrated care organization has been operating since 1 January 2024, the VIVA health plan will also be available in Ticino from 1 January 2025. This concept focuses on preventive and comprehensive healthcare for members, as well as close cooperation between outpatient, inpatient and home care services.

For further information:
AEVIS VICTORIA SA Media and Investor Relations: c/o Dynamics Group, Zurich
Philippe R. Blangey, prb@dynamicsgroup.ch, +41 (0) 43 268 32 35 or +41 (0) 79 785 46 32
Séverine Van der Schueren, svanderschueren@aevis.com, +41 (0) 79 635 04 10

AEVIS VICTORIA SA – Investing for a better life
AEVIS VICTORIA SA invests in healthcare, hospitality & lifestyle and infrastructure. AEVIS′s main shareholdings are Swiss Medical Network Holding SA (80%, directly and indirectly), the only Swiss private network of hospitals present in the country’s three main language regions, MRH Switzerland AG, a luxury hotel group managing eleven luxury hotels in Switzerland and abroad, Infracore SA (30%, directly and indirectly), a real estate company dedicated to healthcare-related infrastructure, Swiss Hotel Properties SA, a hospitality real estate division, and NESCENS SA, a brand dedicated to better aging. AEVIS is listed on the Swiss Reporting Standard of the SIX Swiss Exchange (AEVS.SW). www.aevis.com.

PRESS RELEASE 

Affluent Medical Announces
Participation in Upcoming Scientific Events

Aix-en-Provence, October 8, 2024 – 5:45 p.m. CEST – Affluent Medical (ISIN: FR0013333077 – Ticker: AFME – “Affluent”), a French clinical-stage medical technology company specializing in the international development and industrialization of implantable innovative medical devices, today announced that the company will participate in the following upcoming scientific conferences in the fourth quarter, 2024:

EACTS 2024
38th European Association for Cardio-Thoracic Surgery Annual Meeting
Location: Lisbon, Portugal
Date: 09-12 October 2024
Learn more

ICS 2024
54th International Continence Society Annual Meeting
Location: Madrid, Spain
Date: 23-25 October 2024
Learn more

PCR London Valves
Official Course of the European Association of Percutaneous Cardiovascular Interventions
Location: London, United Kingdom
Date: 24-26 November 2024
Booth: #A2
Learn more

“Affluent Medical is dedicated to pioneering minimally invasive solutions that redefine patient care, enhance lives and address pressing medical needs of more than 600 million individuals worldwide affected with urinary incontinence and mitral insufficiency. In the past year, we have made major steps in the development of our medical devices, notably, our important deal with Edward Lifesciences, the global leader in patient-focused medical innovations for structural heart disease, for our mitral valve technologies, as well as encouraging initial performance results for our artificial sphincter Artus”, explained Sébastien Ladet, CEO of Affluent Medical. “As we progress our programs towards the pivotal and approval stages, we are very much looking forward to meeting with leading experts and companies in their respective fields to discuss latest research, patient needs as well as our programs and partnering opportunities.”

During the events, Affluent will be available to discuss the company’s latest advances in the development of its three innovative medical devices as well as their unique potential:

MITRAL RING KALIOS^TM:

Kalios^TM is the only mitral annuloplasty device that can be simply adjusted percutaneously by a cardiologist to treat both residual or recurrent mitral valve insufficiency, at any time after implantation, repeatedly and with a beating heart, thereby avoiding a repeat open-heart surgery. Affluent Medical believes that Kalios^TM would avoid further intervention for potentially 30% to 40% of patients over a five-year horizon.

Following positive feedback from the FDA in September 2024, Affluent Medical’s objective is to submit a De Novo application with current clinical data at the end of 2025/early 2026, followed by commercial launch, subject to Edwards’ decisions.

MITRAL VALVE EPYGON:

Epygon is the only biomimetic mitral heart valve that mimics the anatomy of the native mitral valve and physiological blood flow, able to be implanted via a transcatheter route. This transcatheter approach avoids an invasive open-heart procedure and associated complications to treat mitral valve insufficiency.

In 2024, the company began a collaboration with Prof. Mohammad Sarraf, MD, interventional cardiologist at the Mayo Clinic in the US, to evaluate the benefits of the biomimetic design of the Epygon valve. This innovative design aims to replicate the anatomy and natural physiology of the native mitral valve to enable patients to recover good cardiac function more quickly.

During the first half of 2024, Affluent Medical accelerated patient evaluations, achieving a fourfold increase in the number of patients included by the end of June 2024 with the goal is to implant up to 10 patients to complete the pilot phase.

URINARY SPHINCTER ARTUS:

Artus is the first artificial urinary sphincter that can be activated by the patient with a simple remote control for the treatment of moderate to severe urinary incontinence. Urinary incontinence is a major public health problem for over 400 million people worldwide without any innovation in the last 40 years, causing patients to suffer a reduced quality of life associated with the psychological disorders related to the disease.

As of mid-September 2024, seven patients had received an implant, representing over half of the planned patients for the pilot phase of the study. The Company plans to implant a total of 10 patients by Q4 2024 and then launch the pivotal phase of the study.

To schedule a meeting during the upcoming conferences, please contact the company at contact@affluentmedical.com.

 

About Affluent Medical

Affluent Medical is a French medical technologies company, founded by Truffle Capital, that aims to become a global leader in the treatment of structural heart diseases, one of the world’s leading causes of mortality, and urinary incontinence, which currently affects one in four adults.

Affluent Medical develops next-generation implants that are minimally invasive, innovative, adjustable and biomimetic, designed to restore essential physiological functions. The candidate products developed by the Company are all undergoing clinical studies in humans.

Subject to raising the funds necessary to finance its strategy and the positive results of ongoing clinical studies, the Company aims to gradually market its products from 2026, directly or indirectly.

For more information, please visit www.affluentmedical.com

 

Contacts:

AFFLUENT MEDICAL   Sébastien LADET Chief Executive Officer investor@affluentmedical.com	SEITOSEI.ACTIFIN Financial communications / Press relations Ghislaine Gasparetto / Jennifer Jullia +33 (0)6 21 10 49 24 / +33 (0)1 56 88 11 19 ghislaine.gasparetto@seitosei-actifin.com / jennifer.jullia@seitosei-actifin.com
PRIMATICE Public Relations France Thomas ROBOREL de CLIMENS +33 (0)6 78 12 97 95 thomasdeclimens@primatice.com	MC SERVICES AG Media relations Europe Caroline BERGMANN / Julia BITTNER +49 (0)211 529252 20 / +49 (0)211 529252 28 affluent@mc-services.eu

 

Mainz Biomed Reports Increased Demand for Enhanced ColoAlert, Existing Partners to Transition to New Version

GANZIMMUN Diagnostics to Feature ColoAlert at the 57th Medizinische Woche Baden-Baden
 

BERKELEY, US and MAINZ, Germany – October 8, 2024 – Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today increasing demand from existing and prospective laboratory partners for its enhanced ColoAlert product that has been launched in July 2024 and is currently being commercialized across Europe and in select international markets. This advanced version of the Company’s colorectal cancer (CRC) screening test is set to become the standard offering for all existing partners, reflecting its proven benefits in optimizing screening efficiency and improving user experience.

Widespread Transition to Enhanced ColoAlert

One of the earliest partners to make the transition is GANZIMMUN Diagnostics, one of Germany’s premier laboratories, which licensed the ColoAlert test. GANZIMMUN will fully implement the enhanced version of the innovative DNA biomarker-based screening product by the beginning of next year, taking advantage of the significant improvements in sample processing and usability that have set a new industry benchmark.

Improving Customer Interest

Partners are particularly drawn to the enhanced features, such as the proprietary DNA stabilizing buffer that ensures reliable results despite varying sample volumes, and the streamlined collection devices that simplify at-home testing for users. These innovations have drastically reduced the need for retesting, offering faster turnaround times for patients, with results available in just 2–3 days from sample arrival.

Promotion at Key Medical Event

GANZIMMUN Diagnostics will showcase the enhanced ColoAlert at the 57th Medizinische Woche Baden-Baden, a medical congress in Germany focusing on complementary medicine, which takes place from October 30 to November 3, 2024. This underscores the increasing role of complementary medicine in cancer prevention and early detection. The event will provide an ideal platform to promote Mainz Biomed’s innovative DNA-based CRC screening test to medical professionals, integrative medicine practitioners, and researchers interested in advanced diagnostic solutions.

“We are excited to support GANZIMMUN in introducing the enhanced ColoAlert at such a prestigious event,” stated Tarrin Khairi-Taraki, VP Commercial Operations at Mainz Biomed. “The 57th Medizinische Woche Baden-Baden provides an excellent opportunity to demonstrate the importance of early colorectal cancer detection and how our innovations are making this process more efficient.”

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

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About GANZIMMUN Diagnostics

GANZIMMUN Diagnostics is one of the leading laboratories in Europe for preventive and complementary medicine. A multidisciplinary team comprising more than 420 employees processes approximately 5,500 laboratory orders per day under the leadership of the experienced laboratory physician, Dr. med. Patrik Zickgraf. The comprehensive diagnostic service spectrum, which includes over 4,000 laboratory parameters, includes besides the basic analytics a huge amount of innovative tests such as the ColoAlert.

To learn more, visit https://www.ganzimmun.de/en/

About Mainz Biomed NV

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. ColoAlert® is marketed across Europe and the United Arab Emirates. The Company is currently running 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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
 

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.

Marinomed Biotech AG publishes remarkable results showing alleviation of allergic eye inflammation in patients treated with Tacrolimus eye drops in peer-reviewed journal

• Tacrosolv eye drops, a low-dose, aqueous Marinosolv-enabled formulation of Tacrolimus, are safe and effective in alleviating symptoms of allergic rhinoconjunctivitis
• Data from phase II dose-finding clinical trial have been published in peer-reviewed Clinical Ophthalmology journal
• Tacrosolv offers great potential in treatment of inflammatory diseases of the ocular surface

Korneuburg, Austria, 08. October 2024 – Marinomed Biotech AG (VSE:MARI) has published clinical data from the phase II dose-finding clinical trial evaluating the efficacy of Tacrosolv eye drops in patients with allergic rhinoconjunctivitis in the peer-reviewed “Clinical Ophthalmology” journal. The placebo-controlled allergen challenge trial assessed the efficacy and safety of two different doses of Tacrosolv. The results show that the higher dose of Tacrosolv eye drops (0.005% Tacrolimus) significantly reduced ocular symptoms of allergic conjunctivitis, and surprisingly, also the associated nasal allergy symptoms. Remarkably, these results were achieved with a dose that is 20-fold lower than that of the only Tacrolimus eye drop product currently on the market.

Eva Prieschl-Grassauer, CSO of Marinomed, comments: “Tacrolimus is an immunosuppressive compound widely used to prevent organ rejection after transplantation or for treating inflammatory skin and eye diseases. In ophthalmology, there is currently only one marketed product in Asia in which Tacrolimus is used as a suspension. Due to its very low solubility in water and the associated very low bioavailability in the inflamed tissue, it takes days to weeks for the therapy to take effect. With our Marinosolv solubilization technology, we could significantly increase the solubility of Tacrolimus in a water-based formulation, thereby improving bioavailability, lowering the needed dose, and leading to a faster onset of action. The encouraging results of this clinical study show that Tacrosolv is a safe and effective treatment option for ocular inflammation. Tacrosolv has the potential to benefit a multitude of inflammatory eye diseases, where the currently limited treatment options create unmet medical need.”

In the clinical trial, adults with a history of allergic conjunctivitis were randomized to either Tacrolimus or placebo treatment for 8 days. Allergic symptoms were induced by controlled allergen exposure on day 1 and 8. During exposure, participants recorded ocular, nasal and respiratory allergy symptoms. The primary endpoint was the mean Total Ocular Symptom Score (TOSS) on day 8. Objective ocular safety parameters were assessed before, during and after exposure.

On day 8, ocular symptoms (mainly redness and watery eyes) were reduced in participants receiving Tacrosolv compared to placebo treatment. Surprisingly, nasal symptoms (mainly itching and sneezing) were significantly reduced in participants treated with Tacrosolv already after the first application. This is an outstanding finding, as the only currently marketed eye drop formulation (Talymus® ophthalmic suspension 0.1%, marketed in Asia) contains a 20-fold higher concentration of Tacrolimus. In conclusion, treatment with Tacrosolv at the dose and frequency studied is safe and significantly alleviates symptoms in participants suffering from allergic rhinoconjunctivitis.

About Marinosolv®:

Marinosolv® is an innovative technology platform that enables the solubilization and enhances the bioavailability of small molecules and peptides that are hardly soluble in aqueous formulations. Consequently, new treatments of a multitude of diseases can be envisaged. The use of the Marinosolv® technology can facilitate efficient drug delivery with a low systemic off-target activity. Existing drugs and off-patent active ingredients can be improved and re-patented as part of new formulations using Marinosolv®. Under the brand Solv4U, Marinomed provides Marinosolv® formulation development in technology partnerships for active ingredients at all stages of drug discovery and for lifecycle extension. For more information on Marinosolv® or Solv4U, please visit https://www.solv4u.com. Scientific publications on Marinosolv® can be accessed in the “Immunology” tabs at https://www.marinomed.com/en/news/scientific-publications.

About Marinomed Biotech AG

Marinomed Biotech AG is an Austrian, science-based biotech company with a growing development pipeline and globally marketed therapeutics. The Company develops innovative patent-protected products in the therapeutic areas immunology and virology based on the platform Marinosolv® and the virus-blocking activity of Carragelose®. The Marinosolv® technology improves the solubility and bioavailability of hardly soluble compounds and is used to develop new therapeutics for autoreactive immune disorders. The virology segment includes Carragelose®-based over-the-counter (OTC) products to prevent and treat respiratory viral infections that are partnered in more than 40 countries. The Company is headquartered in Korneuburg, Austria, and is listed on the Vienna Stock Exchange (VSE:MARI). For further information, please visit: https://www.marinomed.com.

For further inquiries contact:

Marinomed Biotech AG PR & IR: Lucia Ziegler T: +43 2262 90300 158 E-Mail: pr@marinomed.com E-Mail: ir@marinomed.com

Disclaimer

This press release contains forward-looking statements, which are based on current views, expectations and projections of the management of Marinomed Biotech AG about future events. These forward-looking statements are subject to risks, uncertainties and assumptions that could cause actual results, performance or events to differ materially from those described in, or expressed or implied by, such statements. The current views, expectations and projections of the management of Marinomed Biotech AG may be identified by the context of such statements or words such as “anticipate,” “believe”, “estimate”, “expect”, “intend”, “plan”, “project” and “target”. Forward-looking statements are only valid as of the date they are made and Marinomed Biotech AG does not assume any obligation to update, review or revise any forward-looking statements contained in this press release whether as a result of new information, future developments or otherwise. Marinomed, Marinosolv® and Carragelose® are registered trademarks of Marinomed Biotech AG. These trademarks may be owned or licensed in select locations only.