Immunic, Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update

– Key Data Highlighting Vidofludimus Calcium’s Therapeutic Potential in Multiple Sclerosis Presented at 41^st Congress of ECTRIMS –

– Phase 2 CALLIPER Data Demonstrated Statistically Significant 24-Week Confirmed Disability Improvement in Progressive Multiple Sclerosis, With Consistent Signals for Slowing Disability Progression Across Subgroups and Endpoints, Supporting Vidofludimus Calcium’s Neuroprotective Potential and Nurr1 Activation Mechanism –

– Long-Term Phase 2 EMPhASIS Data in Relapsing-Remitting Multiple Sclerosis Showed High Rates of Patients Remaining Free of Confirmed Disability Worsening and Favorable Long-Term Safety and Tolerability –

– Top-Line Data from Twin Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis Expected by Year-End 2026 – 

NEW YORK, November 13, 2025 – Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced financial results for the three and nine months ended September 30, 2025, and provided a corporate update.

“The third quarter was marked by our strong presence at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), during which we had the opportunity to highlight the clinical momentum of our lead asset, vidofludimus calcium (IMU-838), an orally available nuclear receptor-related 1 (Nurr1) activator, and its potential to transform the oral multiple sclerosis (MS) therapy landscape,” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “The collective data meanwhile available from across our clinical MS trials, including the phase 2 CALLIPER and EMPhASIS trials, highlight vidofludimus calcium’s unique promise to slow disability progression in both relapsing and progressive forms of the disease. Notably, new data from our positive phase 2 CALLIPER trial in progressive MS (PMS), also featured in the Best of ECTRIMS 2025 slide deck, showed statistically significant 24-week confirmed disability improvement in the overall patient population and consistent effects across both the primary progressive MS (PPMS) and non-active secondary progressive MS (naSPMS) subgroups, further reinforcing the compound’s neuroprotective and anti-inflammatory characteristics.”

“We believe the CALLIPER data clearly support advancing vidofludimus calcium into phase 3 development in progressive forms of MS. With only one approved therapy currently available for PPMS, there is a significant opportunity in this underserved, multi-billion-dollar market. By slowing disease progression, vidofludimus calcium could help patients maintain independence, manage symptoms more effectively, and achieve improved long-term outcomes.”

Dr. Vitt continued, “Notably, we also presented additional long-term data from the open-label extension (OLE) period of our phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) at ECTRIMS, which further highlighted the robust efficacy signals and favorable safety and tolerability observed, to date. Our twin phase 3 ENSURE trials in relapsing MS (RMS) remain on track. Given vidofludimus calcium’s unique profile and its potential to become the oral therapy of choice addressing the full spectrum of MS, we look forward to reporting top-line data by the end of 2026.”

“We also successfully continued our efforts to meaningfully enhance our strong and multi-layered intellectual property position for vidofludimus calcium. During the quarter, we received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a key patent covering dose strengths of vidofludimus calcium for the treatment of PMS. This newly allowed patent adds another layer of potential exclusivity protection in the United States, with the option for further term extension.”

Third Quarter 2025 Highlights

The CALLIPER data underscored vidofludimus calcium’s neuroprotective potential across PMS populations and its ability to slow disease progression in patients with or without focal inflammation. Consistent 24-week confirmed disability worsening (24wCDW) outcomes were observed across disability endpoints, patient populations and subgroups (including the overall population and in PPMS and naSPMS), and those without baseline inflammatory gadolinium-enhancing (Gd+) lesions during magnetic resonance imaging (MRI). Newly available data regarding 24-week confirmed disability improvement (24wCDI) demonstrated a greater than two-fold probability for vidofludimus calcium over placebo, statistically significant in the overall PMS population, with consistent trends across subtypes. These findings support clinically measurable neuroprotective effects consistent with vidofludimus calcium’s Nurr1 activation mechanism and de-risk a potential phase 3 program, as 24wCDW is an accepted regulatory endpoint to demonstrate clinical benefit in PMS.

Long-term data from the phase 2 EMPhASIS OLE period reinforced vidofludimus calcium’s robust efficacy signals and favorable safety and tolerability profile, demonstrating that it was well-tolerated for treatment durations of up to 5.5 years in patients with RRMS. Among 182 patients remaining on therapy as of January 14, 2025, cumulative exposure totaled ~952 treatment years with an annualized discontinuation rate of only ~6.4%. Most adverse events were mild, with low rates of renal and liver-related events, and no new safety signals observed. Serious adverse events were infrequent, and none were deemed related to treatment.

Anticipated Clinical Milestones

Financial and Operating Results

For the nine months ended September 30, 2025, R&D expenses were $63.0 million, as compared to $58.4 million for the nine months ended September 30, 2024. The $4.5 million increase reflects (i) a $6.2 million increase in external development costs related to the phase 3 ENSURE trials and (ii) a $1.6 million increase in personnel expenses for R&D, of which $0.4 million was related to non-cash stock compensation. The increase was offset by (i) a $2.7 million decrease in external development costs related to IMU-856 primarily due to the timing of the purchase of drug supply for this program and (ii) a $0.6 million decrease across numerous categories.

For the nine months ended September 30, 2025, G&A expenses were $17.0 million, as compared to $14.0 million for the same period ended September 30, 2024. The $3.0 million increase was due to (i) a $1.8 million increase related to personnel expenses, of which $0.8 million was related to non-cash stock compensation, (ii) a $0.6 million increase in legal and consultancy expenses and (iii) a $0.6 million increase related to costs across numerous categories.

For the nine months ended September 30, 2025, interest income was $0.8 million, as compared to $3.0 million for the same period ended September 30, 2024. The $2.1 million decrease was due to a lower average cash balance.

For the nine months ended September 30, 2025, Other Income (Expense) was $1.2 million, as compared to ($1.1 million) for the same period ending September 30, 2024. The $2.3 million increase was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing related to the tranche rights that were established at the time of the deal closing in 2024, (ii) $1.0 million of grant income from the German Federal Ministry of Finance recognized in the first quarter 2025 and (iii) a $0.3 million increase across numerous categories. The increase was offset by a $0.7 million decrease in research and development tax incentives for clinical trials in Australia due to lower clinical trial spend in Australia.

Net loss for the nine months ended September 30, 2025, was approximately $77.9 million, or $0.55 per basic and diluted share, based on 142,811,489 weighted average common shares outstanding, compared to a net loss of approximately $75.3 million or $0.75 per basic and diluted share, based on 99,998,245 weighted average common shares outstanding for the same period ended September 30, 2024.

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; the potential for Immunic’s development programs to safely and effectively target diseases; preclinical and clinical data for Immunic’s development programs; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company’s products or product candidates, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company’s subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.

Contact Information

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

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

US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com

PRESS RELEASE

Biotest obtains approval for new human fibrinogen Prufibry^® in Germany

• New life-saving therapy for patients with congenital and acquired fibrinogen deficiency
• Clinical studies demonstrate efficacy and safety in bleeding control and surgical settings
• Important expansion to Biotest’s intensive care and coagulation factor portfolio
• Produced at the highly efficient Biotest Next Level facility in Dreieich

Dreieich, 13 November 2025.  Biotest AG, part of the Grifols Group, announced today that the German competent authority, the Paul-Ehrlich-Institut, has approved Prufibry^® (human fibrinogen; development name BT524) for the German market. Biotest’s human fibrinogen is a highly purified product with a precisely defined amount of fibrinogen, allowing for a predictable response and a rapid replenishment of fibrinogen, which is important in these critical moments.

“Prufibry^® expands Biotest’s product portfolio in the field of intensive care and coagulation disorders with a new, highly purified plasma protein,” emphasises Dr Jörg Schüttrumpf, Chief Executive Officer of Biotest AG. “With this approval, patients suffering from congenital and acquired fibrinogen deficiency will gain access to an effective, reliable and safe therapy to prevent and control life-threatening bleeding events especially in surgical and trauma settings.”

Clinical development and indications

This approval is based on a comprehensive clinical development program including pivotal Phase III trials. The studies demonstrated that BT524 effectively restored fibrinogen levels and controlled bleeding episodes in patients with congenital afibrinogenemia and hypofibrinogenemia. In addition, perioperative use of BT524 in major surgeries confirmed its efficacy in preventing excessive bleeding when standard coagulation support was insufficient.

The approval covers the following indications in adults, children and adolescents (0-18 years):

Biotest’s human fibrinogen is indicated:

• for the treatment and peri-operative prophylaxis of bleeding in patients with congenital hypo- or afibrinogenaemia with bleeding tendency.
• as complementary therapy to management of uncontrolled severe haemorrhage in acquired hypofibrinogenaemia caused by surgery or trauma.

Manufactured at Biotest Next Level

Biotest’s human fibrinogen is produced in the new “Biotest Next Level” production facility at the Dreieich site. This state-of-the-art manufacturing platform enables high yields, robust viral safety, and sustainable use of the valuable raw material plasma.

The approval represents another important milestone in Biotest’s strategy to broaden its specialty plasma protein portfolio and to strengthen supply security for patients worldwide.

Outlook

With the approval in Germany, the launch of Biotest’s human fibrinogen is expected by the end of 2025. Further approvals in European and international markets are planned.

Prufibry^® joins Biotest’s established coagulation factor products and complements the company’s growing specialty portfolio.

About Prufibry^®

The newly developed manufacturing process of human fibrinogen leads to high-purity fibrinogen with a defined concentration, high level of viral safety and good solubility.

About AdFIrst trial no. 995

The AdFIrst trial was a prospective, active-controlled, multicentre phase III trial investigating the efficacy and safety of the Fibrinogen concentrate (BT524) in patients with acquired fibrinogen deficiency. Patients who had high blood loss during planned spinal or abdominal surgery were randomized 1:1 to treatment with Fibrinogen concentrate (BT524) or fresh frozen plasma (FFP)/Cryoprecipitate. To evaluate the efficacy of BT524, further blood loss was compared between treatment options. Further information about the trial design can be found at www.clinicaltrialsregister.eu (EudraCT number: 2017-001163-20).

About fibrinogen and fibrinogen deficiency

Fibrinogen is a blood clotting factor that is produced in the liver. It plays a key role in primary haemostasis (stopping blood loss from bleeding wounds) and wound healing. In case of a lack or shortage of fibrinogen blood’s ability to clot is impaired which leads to a much greater risk of bleeding and delayed haemostasis. The fibrinogen concentrate alternatives fresh frozen plasma (FFP) and cryoprecipitate contain variable amounts of fibrinogen and must be thawed prior totreatment. The defined amount of fibrinogen in the fibrinogen concentrate will allow a tailor-made, patient specific and highly effective therapy.

About Biotest

Biotest is a provider of biological therapeutics derived from human plasma. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,600 employees worldwide. Since May 2022, Biotest has been a part of the Grifols Group, based in Barcelona, Spain (www.grifols.com).

IR contact

Dr Monika Baumann (Buttkereit)

Phone: +49-6103-801-4406
Mail: ir@biotest.com

PR contact

Miriam Oehme

Phone: +49 -152 07016 992
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201

Preference shares: securities’ ID No. 522723; ISIN DE0005227235

Listing: Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

Stable earnings despite portfolio adjustment – 2025 guidance confirmed, strong growth in branded pharmaceuticals

• Strong organic revenue growth and robust earnings trend in high-margin “Branded pharmaceuticals” segment
• Efforts proceeding as planned to restructure parallel imports product portfolio with focus on contribution margins and to reorganise business model at Arkopharma
• Adjusted EBITDA (excluding vaccine business) and adjusted EBITDA margin stable at prior-year level
• Board of Management confirms full-year guidance for 2025

Grünwald, 13 November 2025 – Dermapharm Holding SE (“Dermapharm”), a rapidly growing manufacturer of branded pharmaceuticals and other healthcare products, today publishes its results for the first nine months of 2025.

Dermapharm Holding SE performed in line with expectations in the first nine months of 2025. Consolidated revenue decreased slightly by 2.3% to EUR 869.4 million as compared to the prior-year period (prior-year period: EUR 890.1 million). Adjusted for the remaining vaccine business, which is in the low double-digit million range, consolidated revenue declined by 1.7%. This was mainly down to the efforts to restructure the product portfolio in the “Parallel import business” segment to focus on contribution margins. Revenue was buoyed by the strong organic growth of 5.8% in the “Branded pharmaceuticals” segment (adjusted for the vaccine business), which however was unable to fully offset the revenue decline, primarily in the “Parallel import business”.

EBITDA adjusted for non-recurring items decreased by 1.8% to EUR 236.0 million in the first nine months of 2025 (prior-year period: EUR 240.3 million). Excluding the vaccine business, adjusted EBITDA improved by 0.8% year on year. Viewed in isolation, the third quarter of 2025 saw adjusted EBITDA grow slightly by 0.8%. Unadjusted EBITDA declined to EUR 230.8 million (prior-year period: EUR 234.1 million). The adjusted and unadjusted EBITDA margins remained virtually stable at 27.1% and 26.5%, respectively (prior-year period: 27.0% and 26.3%), not least due to the declining share of low-margin parallel imports in consolidated revenue.

“Despite a challenging market environment, we maintained a stable level of profitability in the first nine months of 2025 and set a key strategic course. We are particularly pleased with the continued strong growth in our high-margin ‘Branded pharmaceuticals’ segment. The planned restructuring of our portfolio and business model in individual areas lays a foundation for their sustainable, profitable growth, and we are confident about the rest of the year,” said Dr Hans-Georg Feldmeier, CEO of Dermapharm Holding SE.

Branded pharmaceuticals

In the “Branded pharmaceuticals” segment, strong organic growth in the existing business, in particular the Allergopharma Group and the international companies, translated to a 4.2% rise in revenue from EUR 431.6 million in the previous year to EUR 449.8 million. Adjusted for the remaining vaccine business, revenue grew by a notable 5.8%.

Unadjusted EBITDA rose by 3.1% to EUR 198.3 million (prior-year period: EUR 192.3 million), due primarily to organic growth in the existing business. This corresponds to an EBITDA margin of 44.1% (prior-year period: 44.6%). The segment’s adjusted EBITDA likewise rose, increasing by 1.2% to EUR 199.6 million (prior-year period: EUR 197.3 million). Adjusted non-recurring expenses declined significantly from EUR 5.0 million to EUR 1.3 million, and related primarily to restructuring measures.

Other healthcare products

In the “Other healthcare products” segment, Dermapharm generated EUR 269.0 million in revenue in the first nine months of 2025 (prior-year period: EUR 271.7 million). The slight decline in revenue was due primarily to the ongoing reorganisation of Arkopharma’s business model. The organic growth in the rest of the existing business did not fully offset the decline. 

The segment’s adjusted EBITDA amounted to EUR 42.1 million (prior-year period: EUR 45.8 million) and reflected the corresponding revenue trend. Earnings were also impacted by the weaker US dollar and the resulting currency losses. The adjusted non-recurring expenses amounted to EUR 2.8 million (prior-year period: EUR 1.2 million) and were likewise primarily connected with restructuring measures. Unadjusted EBITDA amounted to EUR 39.3 million (prior-year period: 44.6 million), corresponding to an EBITDA margin of 14.6% (prior-year period: 16.4%).

Parallel import business

In the “Parallel import business” segment, there was no let-up in the strategic realignment concentrated on portfolio optimisation with a focus on contribution margins. As expected, the targeted focus on higher-margin products went hand-in-hand with a decline in revenue to EUR 150.6 million (prior-year period: EUR 186.9 million).

The segment’s adjusted EBITDA amounted to EUR -1.6 million (prior-year period: EUR 1.1 million) and is due primarily to the initial decline in the absolute contribution margin as a result of falling product sales. The adjusted non-recurring expenses amounted to EUR 1.2 million (prior-year period: EUR 0.0 million) and were likewise due to restructuring measures. Unadjusted EBITDA amounted to EUR -2.8 million (prior-year period: 1.1 million), and the EBITDA margin amounted to -1.9% (prior-year period: 0.6%). The segment’s earnings continue to develop in line with expectations in the current 2025 financial year as the absolute contribution margins rise.

Board of Management confirms outlook for 2025 overall

Given that the Company performed in line with projections in the first nine months of the current financial year 2025, and in light of the positive outlook for the final quarter, the Board of Management confirms that both consolidated revenue and adjusted EBITDA will be in line with the published forecast range of between EUR 1,160–1,200 million and EUR 322–332 million, respectively.

The full interim statement for Q3 2025 can now be downloaded from https://ir.dermapharm.de/en.

IFRS figures for 9M 2025 and the prior-year period

(excluding segment reconciliation/Group holding company)

*   9M 2025 EBITDA was adjusted for non-recurring items amounting to EUR 5.2 million.
    9M 2024 EBITDA was adjusted for non-recurring items amounting to EUR 6.2 million.

Company profile

Dermapharm – Pharmaceutical Excellence “Made in Europe”

Dermapharm is an innovative and rapidly growing manufacturer of branded pharmaceuticals and other healthcare products. Founded in 1991, the Company is based in Grünwald near Munich. In addition to its main location in Brehna near Leipzig, Dermapharm also operates other production, development and distribution locations, including in Germany, the rest of Europe and the United States.

In the “Branded pharmaceuticals” segment, Dermapharm has more than 1,300 marketing authorisations with more than 390 active pharmaceutical ingredients. Dermapharm’s portfolio of pharmaceuticals is tailored to selected therapeutic areas in which the Company is a market leader, especially in Germany. The Company’s integrated business model extends from in-house product development and production through quality management and logistics to the distribution of branded pharmaceuticals by a trained pharmaceutical sales force.

Dermapharm bundles food supplements, herbal pharmaceuticals, cosmetics, medical devices, herbal extracts and medicinal cannabis in its “Other healthcare products” segment. In this segment, Dermapharm can tap the expertise of Arkopharma, the market leader for phytotherapeutic food supplements in France, and the Spanish company Euromed S.A., a leading global manufacturer of herbal extracts and plant-based active ingredients for the pharmaceuticals, nutraceuticals, foodstuffs and cosmetics industries.

Dermapharm also operates the “Parallel import business” segment under the axicorp brand. axicorp imports originator pharmaceuticals from other EU Member States and resells them to pharmaceuticals wholesalers and pharmacies in Germany. This enables axicorp to benefit from the different pricing structures in the individual EU member states. Based on revenue, axicorp is currently the seventh largest parallel importer in Germany.

With a consistent R&D strategy and numerous successful product and company acquisitions and by stepping up its internationalisation efforts, the Group is continuously optimising its business activities and seeks external growth opportunities in addition to organic growth.

Contact

Investor Relations & Corporate Communications
Britta Hamberger
Tel.: +49 (0)89 64186-233
E-mail: ir@dermapharm.com

3^rd quarter of 2025:

• Sales of €75.3 million (previous year: €70.1 million)
• EBIT before special items of €15.4 million (previous year: €14.2 million)
• Net income of €8.5 million (previous year: €5.3 million)

First 9 months of 2025:

• Sales of €224.1 million (previous year: €215.5 million)
• EBIT before special items of €50.8 million (previous year: €46.7 million)
• Net income of €29.9 million (previous year: €23.4 million)

Forecast for 2025:

• Sales of approx. €320 million (confirmed)
• EBIT before special items of approx. €78 million (confirmed)

Berlin, 13 November 2025. Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) increased sales in the first nine months of 2025 by 4% to €224.1 million compared to the same period last year. EBIT before special items from continuing operations (adjusted EBIT) rose by 9% to €50.8 million. Net profit (from continuing and discontinued operations) grew by 28% to €29.9 million, or €0.48 per share.

In the Medical segment, sales in the first nine months of the year amounted to €119.7 million, up around €15.2 million or 15% on the previous year’s level. The business with pharmaceutical radioisotopes remains the most important source of revenue. Particularly noteworthy here are the developments in sales of generators, licensing, and contract manufacturing & development (CDMO).

The Isotope Products segment generated external sales of €104.4 million, down €6.6 million or approximately 6% compared to the first nine months of the previous year. Shifts between product groups toward lower-margin products have become apparent in comparison to the same period last year.

For the current fiscal year 2025, the Executive Board confirms its profit forecast published on March 27, 2025, with sales of approx. €320 million and an adjusted EBIT of approx. €78 million.

The complete quarterly report can be viewed here: https://www.ezag.com/Q32025en

About Eckert & Ziegler.
Eckert & Ziegler SE, with more than 1.000 employees, is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

Your contact:
Eckert & Ziegler SE, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-138, karolin.riehle@ezag.de, www.ezag.com 

Press Release // November 13, 2025
 

Formycon publishes nine-month results and confirms guidance – Pipeline progress and strong partnerships drive fiscal year 2025

• Guidance for 2025 confirmed – Revenue and earnings development in line with expectations
• FYB202 (Stelara^®1 biosimilar): Market penetration in the US and Europe continues
• Significant pipeline progress: FYB201 – Launch of the first pre-filled syringe for a ranibizumab biosimilar in Europe; settlement for FYB203 enables US launch; patient recruitment for FYB206 pharmacokinetic (PK) study successfully completed
• New regulatory guidelines in the US accelerate biosimilar approvals and confirm Formycon’s development strategy
• International partnerships in Europe, Australia, and Latin America expand market presence
• Invitation to today’s conference call at 3:00 p.m. (CET)

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today reports on the Group’s business development and financial results for the first nine months of fiscal year 2025. During the reporting period, the company successfully expanded its operational activities and consistently pursued its strategic priorities in the areas of development, financing, partnerships, and competitiveness. Based on these positive developments, Formycon confirms its existing guidance for the 2025 fiscal year.

Enno Spillner, CFO of Formycon, commented: “Operational development and financial performance in the third quarter were in line with expectations. In addition, we confidently anticipate a dynamic fourth quarter and expect significant sales momentum from the ongoing market penetration of our Stelara^® biosimilar FYB202 in the US and Europe. In particular, the exclusive US distribution agreement concluded by Fresenius Kabi with CivicaScript promises a significant increase in sales in the fourth quarter. In addition, we expect further positive momentum from the advanced commercialization discussions for our Keytruda^®2 biosimilar candidate FYB206 in selected regions. Our rigorous, streamlined development program without a Phase III study has enabled us to advance the clinical development of FYB206 significantly faster and more cost-efficiently. The successful completion of patient recruitment once again underscores our pioneering role in global biosimilar development and at the same time strengthens our appeal for future partnerships. With strict cost control and the solid financing structure from our first corporate bond in the summer, we are well positioned to achieve our annual targets.”

Group revenues and earnings development on track – guidance for 2025 confirmed

In the first nine months of 2025, the Formycon Group generated revenues of approximately €19.5 million (9M/2024: €41.1 million). While the previous years’ figures included one-time payments from license and milestone agreements for FYB202, current revenues increasingly derive from recurring proceeds from the marketing of approved biosimilars, from development services for out-licensed or jointly developed projects, and from service payments for supply chain coordination.

Revenues from the ranibizumab biosimilar FYB201 from direct participation in commercialization proceeds amounted to €1.5 million (9M/2024: €6.0 million). As previously reported, Sandoz temporarily paused commercialization in the US from the second quarter of 2025 for tactical market reasons; based on current information, resumption is planned for the first quarter of 2026. In the remaining 24 markets outside the US – including Europe and the MENA region – FYB201 continued to be marketed, and development proceeded as expected. After the end of the reporting period, FYB201 was launched as the first ready-to-use syringe of a ranibizumab biosimilar in the first European countries. The syringe system sets new standards in quality and innovation and increases the marketing potential of the ranibizumab biosimilar FYB201 in Europe.

The Stelara^® biosimilar FYB202 (Otulfi^®3/Fymskina^®4) developed according to plan during the reporting period. Following the market launch by our partner Fresenius Kabi in March, market development is progressing steadily. In the US, FYB202 is primarily distributed through the pharmacy benefit channel. An exclusive distribution agreement with CivicaScript and other contracts have now been concluded. In Europe, FYB202 has already been launched in 18 countries. In Germany, our distribution partner Ratiopharm has additionally been handling sales for FYB202/Fymskina^® since this summer. Revenues from direct participation in the commercialization of FYB202 amounted to €3.2 million (9M/2024: €0). Milestone payments of €0.5 million were also realized for approvals in additional regions. Based on the contracts concluded and the expected order volumes, Formycon anticipates a significant increase in revenue contributions from FYB202 in the final quarter of 2025.

The Group’s earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to
€-21.4 million in the reporting period (9M/2024: €-17.7 million) and were thus in line with planning. This development mainly reflects the temporary decline in sales revenues resulting from the transition phase between one-time license payments and the increasing share of sales from commercialized products. Adjusted EBITDA amounted to €-21.7 million (9M/2024: €2.9 million) and includes the earnings contribution from the 50% stake in Bioeq AG.

The at-equity result of Bioeq AG for the first nine months was €-0.3 million (9M/2024: €20.6 million), reflecting the temporary marketing pause for FYB201 in the US. The forecast for EBITDA and adjusted EBITDA in the range of €-20 million to €-10 million for the full year remains unchanged.

The current positive developments in easing regulatory requirements, such as the waiver of Phase III clinical trials as a standard requirement, are paving the way for shorter and less expensive development cycles and allowing Formycon to focus its structures on greater efficiency. Based on the successful development and approval of three biosimilar products, the company is leveraging the experience it has gained to pool capacities in a targeted manner, further optimize the use of resources, and significantly reduce costs. The growing use of digital technologies and artificial intelligence is increasingly helping to make development processes focused, lean, and thus competitive. Formycon is aiming for EBITDA-profitable corporate development in the medium term and expects that a positive EBITDA result can ideally be achieved in 2026, but no later than in the 2027 fiscal year.

In the second quarter of 2025, Formycon AG successfully placed its first corporate bond 2025/2029 (ISIN NO0013586024 / WKN A4DFJH) in Nordic Bond format with a total volume of €70 million on the capital market. The four-year, floating-rate bond (maturity: July 2029) bears interest based on the 3-month Euribor plus a margin of 7.00% p.a.; interest payments are made quarterly. Investor feedback during the roadshow and after the placement confirms confidence in Formycon’s promising growth strategy and business model.

In connection with the successful placement of a €70 million corporate bond, the working capital forecast was already raised in the first half of the year. Working capital amounted to €83.2 million in the first nine months (9M/2024: €65.8 million), securing the financing of ongoing development activities and operating business in the medium and long term.

Operational development on track – strategic progress and settlement and license agreement confirm outlook for the full year

Dr. Stefan Glombitza, CEO of Formycon AG, said: “In fiscal year 2025, we further refined our strategy in the areas of development, partnerships, and competitiveness and achieved important milestones. With the introduction of the innovative FYB201 prefilled syringe, we are setting new standards in ophthalmic care and creating additional differentiation in the European market. The settlement of the patent dispute with Regeneron regarding FYB203 also marks a decisive step forward in the US market entry of our Eylea^®5 biosimilar and strengthens our position in one of the largest biosimilar markets worldwide. The latest initiative by the US health authority to simplify the approval process for biosimilars marks a significant regulatory advance with immediate relevance for our industry. The planned facilitations can significantly shorten development times and at the same time make them more cost-effective. We anticipated this change early on and aligned our clinical strategy for our Keytruda^® biosimilar candidate FYB206 accordingly in consultation with the FDA. The streamlined design of our clinical program already shows that scientific excellence can be successfully combined with economic efficiency. These developments confirm our approach and create additional opportunities to develop and bring biosimilars to market faster, more cost-effectively, and with high quality.”

In the third quarter of 2025, Formycon advanced the development of key biosimilar projects as planned and achieved significant operational progress. This includes, in particular, further progress with the pembrolizumab biosimilar candidate FYB206. Following positive regulatory feedback, a Phase III study was not required as therapeutic comparability can be demonstrated by comprehensive analytical data and the ongoing Phase I Pharmacokinetic (PK) study. Patient recruitment for this ongoing Phase I PK study was already completed in July. Formycon expects results for the primary endpoint in the first quarter of 2026.

Further important steps toward market expansion and portfolio differentiation were taken after the end of the reporting period: One focus was on the launch of the pre-filled syringe version of the ranibizumab biosimilar FYB201 (Ranivisio^®6) in Europe by our partner Teva. At the beginning of October, a settlement and license agreement for FYB203 was concluded with Regeneron, which resolves all the patent disputes in connection with the aflibercept biosimilar FYB203/Ahzantive^®7 in the US. From today’s perspective, this means that the biosimilar, which has already been approved by the FDA, could enter the market in the fourth quarter of 2026. Exclusive commercialization in the United States and Canada will be carried out by the distribution partner Valorum Biologics based on the license agreement concluded at the end of June 2025.

In addition, exclusive commercialization agreements for FYB203 were signed with Actor Pharmaceuticals for Australia and with Megalabs for Latin America. A co-marketing partnership was agreed with Horus Pharma for selected European countries. These partnerships will expand FYB203’s future geographic market coverage and penetration and strengthen Formycon’s competitive position. At the same time, development activities for early-stage projects continued as planned.

Key financial performance indicators at a glance

Balance sheet IFRS

Condensed statement of comprehensive income

Condensed cash flow statement

Conference call and dial-in details

The Executive Board will discuss the company’s performance and key financial figures and provide an outlook for the remainder of fiscal year 2025. The conference call, which will be broadcast live on the Internet, will take place on Thursday, November 13, 2025, at 3:00 p.m. (CET) in English.

To participate in the conference call, please register at:

https://webcast.meetyoo.de/reg/KYTa1G3ju56X

After registration, participants will receive a confirmation email with their individual dial-in details.

The presentation and audio webcast can be accessed via the following link:

https://www.webcast-eqs.com/formycon-2025-q3

Following a brief presentation, the Executive Board will be available to answer questions from analysts. The conference call will be recorded and subsequently available on the Formycon website at: https://www.formycon.com/en/investors/publications/.

1. Stelara^® is a registered trademark of Johnson & Johnson
2. Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA
3. Otulfi^® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries
4. Fymskina^® is a registered trademark of Formycon AG
5. Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
6. Ranivisio^® is a registered trademark of Bioeq AG
7. AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH

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 and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline 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, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. 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.

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.

Hamburg, Germany, 12 November 2025:
Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, Prime Standard, ISIN: DE0005664809, WKN 566480; NASDAQ: EVO) today announced that it has received a US$ 5 m milestone payment from Bristol Myers Squibb, following the acceptance of an Investigational New Drug (“IND”) application by the U.S. Food and Drug Administration (“FDA”) in their strategic protein degradation partnership. The drug candidate, a cereblon E3 ligase modulator (“CELMoD™”) was developed under the collaboration, and a Phase 1 clinical trial is expected to begin in 2026.

Initiated in 2018, the collaboration combines Evotec’s high-performance multi-omics screening as well as AI-supported data analytics and drug design capabilities with Bristol Myers Squibb’s industry-leading library of CELMoDs™. The collaboration, expanded in 2022, continues to deliver on its goal to identify novel molecular glue degraders for high-value targets in the field of oncology and beyond.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are excited to have reached this important achievement in our collaboration with Bristol Myers Squibb, and to move one step closer to bringing the first compound of our molecular glue degrader pipeline to the clinic. This IND acceptance represents not only a major scientific and regulatory milestone but also validates the strength of our collaboration and emphasizes the enormous potential for delivering multiple first-in-class products to market.“

About molecular glue degraders
Conventional small molecule therapeutics work via a drug-induced interference with a protein activity. This limitation to agonistic or antagonistic functions renders about 90% of proteins “undruggable”. Also, conventional small molecules only work while they are actively binding to the receptor, which typically requires a treatment regimen consisting of one or even several carefully dosed medications every day.

Molecular glue degraders are compounds that induce interactions between an E3 ubiquitin ligase and a molecular target. The induced interaction results in ubiquitination and subsequent degradation of the recruited protein. Through this mechanism of action molecular glues are not restricted to the agonistic/antagonistic features of a protein, thus massively expanding the range of the druggable proteome. Also, the molecular glue itself is not degraded in the process and can trigger the degradation process several times over, thus leading to longer-lasting therapeutic effects.

About Evotec’s strategic collaboration with Bristol Myers Squibb in molecular glues
In 2018, Evotec entered a long-term strategic drug discovery and development collaboration in the field of molecular glues with Celgene, now Bristol Myers Squibb. Bristol Myers Squibb is a leader in this field based on its unique library of CELMoDs™. The collaboration aims to discover and develop a leading pipeline of molecular glue degraders for a range of therapeutic indications leveraging all of Evotec’s proprietary PanOmics and PanHunter platforms as well as AI/ML-based drug discovery and development capabilities.

Evotec applies high-end proteomics and transcriptomics at industrial scale to profile and select promising drug candidates based on comprehensive cell biological profiles. Evotec’s leading PanOmics screening capabilities are delivering unmatched throughput. The selection of the most promising candidates for drug development is facilitated by Evotec’s PanOmics data analysis platform PanHunter. PanHunter supports the integration and analysis of these data sets and thereby enables the selection of the most promising CELMoDs™ for further progression into lead optimization.

About Evotec SE
Evotec is a life science company that is pioneering the future of drug discovery and development. By integrating breakthrough science with AI-driven innovation and advanced technologies, we accelerate the journey from concept to cure — faster, smarter, and with greater precision.

Our expertise spans small molecules, biologics, cell therapies and associated modalities, supported by proprietary platforms such as Molecular Patient Databases, PanOmics and iPSC-based disease modeling.

With flexible partnering models tailored to our customers’ needs, we work with all Top 20 Pharma companies, over 800 biotechs, academic institutions, and healthcare stakeholders. Our offerings range from standalone services to fully integrated R&D programs and long-term strategic partnerships, combining scientific excellence with operational agility.

Through Just – Evotec Biologics, we redefine biologics development and manufacturing to improve accessibility and affordability.

With a strong portfolio of over 100 proprietary R&D assets, most of them being co-owned, we focus on key therapeutic areas including oncology, cardiovascular and metabolic diseases, neurology, and immunology.

Evotec’s global team of more than 4,800 experts operates from sites in Europe and the U.S., offering complementary technologies and services as synergistic centers of excellence. Learn more at www.evotec.com and follow us on LinkedIn and X/Twitter @Evotec.

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For further information, please contact:

Media
Susanne Kreuter 
VP Head of Strategic Marketing 
Susanne.Kreuter@evotec.com 

Investor Relations
Volker Braun
EVP Head of Global Investor Relations & ESG
Volker.Braun@evotec.com

Pentixapharm Publishes 9-Month Figures for 2025

• Loss of the reporting period €12,7 million (attributed to research and development activities, personnel and other operating expenses)
• Revenue of the reported period €117 thousands
• Balance sheet total as of September 30, 2025: €43 million
• Adjusted Guidance for the fiscal year 2025: expected loss approximately €18 million (before: €23.5 million).

Berlin, Germany, 12 November 2025

The Executive Board of Pentixapharm Holding AG announced the following today:

Based on the newly published interim financial statements, the Group closed the first nine months of the 2025 fiscal year with a loss of EUR 12.7 million.

Based on current planning, the Company adjusts the guidan cefor the full 2025 fiscal. The Executive Board now expects a loss of approximately €18 million (before €23.5 million) as published on 06 November 2025.

This forecast includes research and development expenses as well as personnel and other operating expenses while potential income from out-licensing is not included in the forecast.

The full interim financial statements is available on the Pentixapharm Holding AG Investor Relations website: www.pentixapharm.com/investors/reports.

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops first-in-class ligand- and antibody-based radiopharmaceuticals designed to transform patient care across oncology and beyond. Its late-stage pipeline is anchored by CXCR4-targeted programs, including a Phase 3-ready diagnostic candidate for primary aldosteronism and pioneering therapeutic programs in a number of hematological and solid cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-escape marker over-expressed in multiple hard-to-treat cancers. Complemented by reliable isotope supply from Eckert & Ziegler, and a robust global clinical network, Pentixapharm is uniquely positioned to deliver innovative radiopharmaceuticals that address high unmet need, improve patient outcomes, and create significant growth opportunities in one of the fastest-growing areas of precision medicine.

Pentixapharm Investor and Media Contact

ir@pentixapharm.com