On July 28, 2022 Step Pharma, a world leader in CTPS1 inhibition for the targeted treatment of cancer, reported that its lead asset STP938 has cleared both an Investigational New Drug (IND) application by the Food and Drug Administration (FDA), and a clinical trial application (CTA) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), enabling Step Pharma to progress STP938, its first-in-class, selective CTPS1 inhibitor into the clinic in the US and UK (Press release, Step Pharma, JUL 28, 2022, View Source;utm_medium=rss&utm_campaign=step-pharma-progresses-into-oncology-clinical-trials-with-stp938-the-worlds-most-advanced-ctps1-inhibitor [SID1234617049]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

STP938 has now entered an open label, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of STP938 in adult subjects with relapsed/refractory B cell and T cell lymphomas. Further details of the study can be found on clinicaltrials.gov under the identifier NCT05463263. Patients with such cancers currently face high relapse rates from existing treatments.

Step Pharma is pioneering a novel class of oral drugs that specifically inhibits nucleotide synthesis and the enzyme cytidine triphosphate synthase 1 (CTPS1) in particular, originally identified as an essential gene for lymphocyte proliferation. By targeting CTPS1, Step Pharma has unlocked the ability to selectively target the de novo pyrimidine synthesis pathway in cancer cells. This ground-breaking approach should enable the highly selective treatment of both blood cancers and solid tumours.

Andrew Parker, Chief Executive Officer of Step Pharma, said:

"Our unique approach to cancer treatment has the potential to yield a novel targeted cancer therapy that can form the backbone of both blood and solid tumour cancer treatment regimens. We are delighted to have moved STP938 into the clinic for hard-to-treat lymphomas with the ultimate goal of improving the lives of millions of cancer patients."

Dr. Brian Schwartz, Chief Medical Officer, commented:

"The clinical trial approvals by both the US FDA and UK MHRA are a significant milestone for Step Pharma and our highly differentiated lead candidate STP938, as we become a clinical-stage company and move at speed to bring this first-in-class treatment to cancer patients with high unmet medical needs."

Step Pharma will initially investigate STP938 in blood cancers, with a focus on T cell lymphomas, where there has been no improvement in five-year survival rates for over 20 years. However, as studies have shown that all cancer cells require CTPS1 for DNA synthesis, STP938 could be a key component of a multitude of cancer treatment regimens.

On July 28, 2022 Sareum Holdings plc (AIM: SAR), the specialist drug development company, reported that it has submitted an application for a Clinical Trial Authorisation ("CTA") to the UK Medicines and Healthcare Products Regulatory Agency ("MHRA") for the development of SDC-1801 as a potential new therapeutic for a range of autoimmune diseases with a focus on psoriasis (Press release, Sareum, JUL 28, 2022, View Source [SID1234617048]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sareum also provides a broader update on operational activities and pipeline progress.

OPERATIONAL HIGHLIGHTS – STRONG PIPELINE PROGRESS

SDC-1801 (autoimmune disease)

SDC-1801 is a TYK2/JAK1 inhibitor being developed as a potential new therapeutic for a range of autoimmune diseases with an initial focus on psoriasis, an autoimmune condition affecting the skin.

Preclinical development activities required to apply for the CTA have been successfully concluded and, consistent with the Company’s clinical development plan, an application for a CTA has now been filed.

TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune system and has strong clinical validation in psoriasis and psoriatic arthritis. Psoriasis is an autoimmune dermatological condition affecting more than 60 million adults worldwide, with a market size for potential treatments worth more than US$30 billion. Sareum believes that TYK2/JAK1 inhibition offers potential for increased efficacy in psoriasis, compared with existing approved therapies.

Sareum, working alongside a specialist contract research organisation (CRO), has designed a Phase 1a/b clinical trial with SDC-1801 in healthy subjects and psoriasis patients. Subject to regulatory approval from MHRA, the Phase 1a trial is planned to commence in Q4 2022 and will investigate the safety and tolerability of an oral formulation of SDC-1801 in ascending doses administered to healthy subjects. In addition, the trial will evaluate the effect of SDC-1801 on certain biomarkers of autoimmune disease that could be predictive of efficacy when tested in patients.

The Phase 1a part of the trial is expected to provide safety and dosing information applicable for any future trials in patients with other autoimmune diseases and the acute respiratory symptoms of viral infections, including COVID-19, should the Company decide to progress such trials.

Provided satisfactory safety data is obtained from this initial study, and subject to additional funding, a Phase 1b clinical study will commence in psoriasis patients in 2023. The CRO conducting and managing the studies has extensive experience in conducting trials in inflammatory diseases and will recruit up to 120 subjects at a site in Manchester, UK.

Synthesis of SDC-1801 drug substance under GMP conditions has been completed successfully, with a surplus of material for the planned Phase 1 clinical trials. GMP-compliant manufacture of capsules of SDC-1801, intended for use in the Phase 1 trial, is also complete, and the capsules are undergoing rigorous quality control checks before delivery to the clinical unit.

SDC-1802 (cancer immunotherapy)

Sareum continues to work on the translational studies needed to define the optimal cancer application prior to completing toxicology and manufacturing studies.

In April 2022, the Company was granted a new patent, protecting the SDC-1802 molecule and pharmaceutical preparations thereof as a therapeutic to treat T-cell acute lymphoblastic leukaemia (T-ALL – a cancer of a particular type of white blood cell called a T lymphocyte) and other cancers that are dependent on TYK2 kinase for survival.

Licensed Programme – SRA737: A Selective Chk1 inhibitor

As noted in April 2022, Sierra Oncology, Inc ("Sierra"), the licence holder for SRA737 (a novel Chk1 inhibitor discovered and initially developed by scientists at The Institute of Cancer Research in collaboration with Sareum, and with funding from Sareum and Cancer Research UK, licensed to Sierra in September 2016), has been acquired by GlaxoSmithKline plc ("GSK") for US$1.9 billion in cash. The transaction was completed on 1 July 2022, and we await an update concerning GSK’s plans in respect of SRA737.

FINANCIAL POSITION

Sareum had a cash position of approximately £4.3 million as at 30 June 2022 (cash of £5.6 million as at 31 December 2021).

Dr Tim Mitchell, CEO of Sareum, commented:

"The CTA application for SDC-1801 is an important milestone as we advance this promising potential new therapeutic into the clinic.

"SDC-1801 is a TYK2/JAK1 inhibitor which we believe has significant potential in autoimmune disease and we plan to explore this initially in psoriasis, where we believe dual inhibition of both TYK2 and JAK1 has the potential to offer superior efficacy compared to small molecules currently available and in development inhibiting each of the targets individually.

"We have completed most of the preparatory work for the clinical trial and have built a robust data package to support our ongoing partnering activities for this asset. Subject to regulatory approval by MHRA, we look forward to advancing SDC-1801 into clinical development."

Investor Presentation:

A presentation to the investment community by Chief Executive Tim Mitchell and Chief Scientific Officer John Reader will take place on 4 August 2022 at 10.00am via the Investor Meet Company platform.

Existing and potential investors wishing to participate in the presentation can register here.

Questions can be submitted before the event via the Investor Meet Company dashboard or at any time via the live presentation via the "Ask a Question" function. Responses from the Q&A session will be published at the earliest opportunity on the IMC platform.

A copy of the presentation will be made available on the Company’s website following the presentation.

On July 28, 2022 NEC reported that Consolidated Financial Results for the Three-month Period Ended June 30, 2022 (April 1, 2022 – June 30, 2022) (Press release, NEC, JUL 28, 2022, View Source [SID1234617047])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(1) Consolidated Operating Results (Percentage indicate year-on-year changes.)
(2) Consolidated Financial Position

2. Dividends

3. Consolidated Financial Results Forecast for the Year Ending March 31, 2023 (April 1, 2022 – March 31, 2023)

This consolidated financial results falls outside the scope of quarterly review procedures to be performed by certified public accountants or an audit firm.

*Explanation concerning the appropriate use of the financial results forecast and other special matters (Adjusted profit (loss)) "Adjusted operating profit (loss)" is an indicator for measuring underlying profitability in order to clarify the contribution of acquired companies to the NEC Group’s overall earnings. It is measured by deducting amortization of intangible assets recognized as a result of M&A and expenses for acquisition of companies (financial advisory fees and other fees) from operating profit (loss).

Also, "Adjusted net profit (loss) attributable to owners of the parent" is an indicator for measuring underlying profitability attributable to owners of the parent. It is measured by deducting adjustment items of operating profit (loss) and corresponding amounts of tax and non-controlling interests from net profit (loss) attributable to owners of the parent.

(Cautionary statement with respect to forward-looking statements) The forward-looking statements such as operating results forecast contained in this statements summary are based on the information currently available to NEC Corporation ("the Company") and certain assumptions considered reasonable. Actual operating results may differ significantly from these forecasts due to various factors. For details, please refer to "2. Cautionary Statement with Respect to Forward-Looking Statements" on page 14. (How to obtain supplementary financial materials and information on the financial results briefing) On July 28, 2022, the Company will hold a financial results briefing for the institutional investors and analysts. Presentation materials will be posted on the company website after the release of financial results, and the presentation video and Q&A summary will be also posted on the company website promptly after the financial results briefing. In addition to the above, the Company periodically holds briefings on business and operating results for the individual investors. Presentation materials and Q&A summary will be posted on the company website promptly after the briefing. For the schedule and details, please check the company website. 1. Consolidated Financial Results for the Three-month Period Ended June 30, 2022 (April 1, 2022 – June 30, 2022) (1) Consolidated Operating Results (Percentage indicate year-on-year changes.) 2. Dividends 3. Consolidated Financial Results Forecast for the Year Ending March 31, 2023 (April 1, 2022 – March 31, 2023)

On July 28, 2022 Sanofi reported that Q2 2022 sales growth of 8.1% at CER driven by Dupixent, Rare Disease, Vaccines and CHC (Press release, Sanofi, JUL 28, 2022, View Source [SID1234617046])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Specialty Care grew 21.6% driven by Dupixent (€1,963 million, +43.4%), and double-digit growth in Rare Disease
Vaccines up 8.7% due to strong rebound of Travel and Booster vaccines as well as continued PPH franchise growth
General Medicines achieved 6.0% growth in core assets despite lower COVID-19 related demand for Lovenox
CHC delivered 5th consecutive quarter of growth (+9.1%) driven by Cough & Cold, Allergy and Digestive Wellness
Q2 2022 business EPS(1) up 16.7% at CER driven by higher sales and improving margins

BOI margin up 1.3 ppt to 27.2% due to margin improvement from efficiency gains and EUROAPI deconsolidation
€2.6bn savings achieved at the end of Q2, with the majority reinvested in growth drivers and R&D
Business EPS(1) of €1.73, up 25.4% on a reported basis and 16.7% at CER
IFRS EPS of €0.94 (down 2.1%)
Progress on Corporate Social Responsibility strategy

Sanofi’s Global Health Unit launches a fund for healthcare solutions in underserved regions and Impact, a new brand dedicated for non-profit distribution of 30 Sanofi products to at-risk populations in 40 lower-income countries
Valyou program continues to improve access through lower out-of-pocket cost of insulins for uninsured patients in the U.S.
Sanofi upgraded its scope 3 GHG emission reductions ambition to -30% by 2030, unveiling low energy intensity vaccines facility
Key milestone and regulatory achievements on R&D transformation

Efanesoctocog alfa, the first factor VIII therapy to be granted FDA Breakthrough Therapy Designation for hemophilia A
Dupixent approved in the U.S as first treatment for adults and children aged 12 and older with eosinophilic esophagitis and as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis
FDA accepted Dupixent for priority review in adults with prurigo nodularis
Nexviadyme and XenpozymeTM approved in EU
Next-generation COVID-19 booster demonstrated strong results against variants of concern, including Omicron
Full-year 2022 business EPS guidance revised upward

Sanofi now expects 2022 business EPS(1) to grow approximately 15%(2) at CER, barring unforeseen major adverse events. Applying average July 2022 exchange rates, the positive currency impact on 2022 business EPS is estimated between +7.5% to +8.5%
Sanofi Chief Executive Officer, Paul Hudson, commented:

"Our performance in the second quarter was again marked by higher sales across our key growth drivers and outstanding financial results leading us to upgrade our business EPS guidance for the full-year. Notably, we saw significant growth momentum from our Specialty Care business, mainly driven by Dupixent. While we continue to increase our investment in R&D, we delivered important pipeline milestones such as the approval of Dupixent in its fourth disease indication, Eosinophilic Esophagitis. Earlier this month, we had the opportunity to showcase at ISTH the transformative potential of efanesoctocog alfa, the first factor replacement therapy for hemophilia A to receive FDA Breakthrough Therapy Designation. We are also making great progress in advancing our fully integrated social impact strategy, notably in Affordable Access with the launch of Impact, a dedicated brand for non-profit distribution to enable the secure distribution of 30 Sanofi medicines in 40 lower-income countries. As we continue to deliver ahead of schedule on our Play to Win strategy, we are confident in our business outlook for the second half and as a result, we are reiterating our commitment to achieving the BOI margin target of 30% in 2022."

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9). (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 9). The consolidated income statement for Q2 2022 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2021 business EPS was €6.56; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 9).

On July 28, 2022 Fresenius Medical Care reported it’s financial performance in Q2/22 was significantly impacted by worsened labor shortages and related meaningfully increased wage inflation in the U.S (Press release, Fresenius, JUL 28, 2022, View Source [SID1234617045]). The further deterioration of the macro-economic environment resulted in accelerated non-wage inflation, particularly higher supply chain costs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Against this backdrop and growing indications for a persistent unfavorable development of these and other factors, Fresenius Medical Care has revised its outlook for FY/22.

All other Fresenius Group segments confirm their respective outlook for FY/22 for both revenue and EBIT.

However, as a consequence of the development at Fresenius Medical Care, and despite all other Fresenius Group segments confirming their respective outlook for both revenue and EBIT, Fresenius now also revises its Group outlook for FY/22. At constant currency, the Company now anticipates Group sales1 to grow in a low-to-mid single-digit percentage range (previously: mid-single digit percentage range) and Group net income2,3 to decline in a low-to-mid single-digit percentage range (previously: increase in a low-single-digit percentage range).

1 FY/21 base: €37,520 million
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/21 base: €1,867 million; before special items; FY/22: before special items

Stephan Sturm, CEO of Fresenius, said: "As a globally active healthcare group, we, too, have inevitably been impacted by – in many cases massive – cost increases, growing problems in the global supply chains, and staff shortages. And unlike companies in other industries, we cannot simply pass on the resulting cost burdens in the short term by raising our prices. To the extent possible and foreseeable, we factored these burdens into the guidance we provided in February and May. In the meantime, though, it has become apparent that patient-facing healthcare services in the United States are affected even more heavily, hence also Fresenius Medical Care. It will take fortitude and energy to overcome this particularly challenging phase, and I am therefore very pleased that Carla Kriwet will assume her new position as CEO of Fresenius Medical Care quite a bit earlier than initially planned. I am confident that, together with her colleagues, she will find the right solutions and lead Fresenius Medical Care into a successful future."

"Our goal at Fresenius is, and remains, to create more value: for our patients, our employees and our shareholders," added Sturm. "We are working tirelessly, guided by our clear strategic priorities, to achieve this. And we continue to see good prospects, despite the current burdens and difficulties resulting from global crises. Not least because, from our strong market positions, we moved early to capitalize on the right trends, such as home dialysis. Healthcare is a market of the future that we want to play an important role in shaping, and where we intend to continue our sustained, profitable growth."

Assumptions for guidance FY/22
Due to the meaningfully increased uncertainty and volatility related to the war in Ukraine, the ongoing impacts of the COVID-19 pandemic, and a rapidly worsening global macro-economic development, Fresenius now expects significantly more pronounced headwinds in 2022 from supply chain disruptions and cost inflation, including energy prices. Furthermore, Fresenius expects significant negative effects from ongoing labor shortages and associated wage inflation, especially at Fresenius Medical Care in the U.S.

The war in Ukraine is directly and indirectly affecting Fresenius Group operations. The direct adverse effects of the war amounted to €20 million at net income1 level of Fresenius Group in H1/22 and are treated as a special item. Fresenius will continue to closely monitor the potential further consequences of the war, including balance sheet valuations. The guidance does not consider a significant disruption of gas or electricity supplies in Europe.

COVID-19 will continue to impact Fresenius Group operations in 2022. An unlikely but possible significant deterioration of the situation triggering containment measures that could have a significant and direct impact on the health care sector without any appropriate compensation is not reflected in the Group’s FY/22 guidance.

Furthermore, the updated assumptions for Fresenius Medical Care’s FY/22 guidance are also fully applicable to Fresenius Group’s FY/22 guidance. All of these assumptions are subject to considerable uncertainty. The acquisition of Ivenix and the announced acquisition of the majority stake in mAbxience as well as any further potential acquisitions remain excluded from guidance.

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA

Group medium-term targets
As a result of the updated expectations for FY/22, Fresenius now believes its medium-term net income1 target is no longer achievable. Fresenius had expected Group organic net income1 growth to be at the bottom end of the 5% to 9% compounded annual growth rate (CAGR) range for 2020 to 2023. At the same time, Fresenius specifies its Group organic sales growth target to reach the low-end of the targeted 4% to 7% compounded annual growth rate (CAGR) range for 2020 to 2023.

Cost and efficiency program
The Group’s cost and efficiency program is running according to plan and Fresenius confirms its increased savings targets provided in February 2022 of at least €150 million p.a. after tax and minority interest in 2023. For the years thereafter, a further significant increase in sustainable cost savings is expected.

Management Board change at Fresenius Medical Care
Dr. Carla Kriwet will now join Fresenius Medical Care as CEO on October 1, 2022, earlier than previously announced and Rice Powell will step down as CEO effective September 30, 2022.

Preliminary Q2 and H1/22 results2

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA
2 EBIT and net income before special items
3 Excluding Ivenix acquisition

Fresenius Kabi preliminary financial results
Sales in Q2/22 increased by 8% (2% in constant currency) to €1,896 million (Q2/21: €1,755 million). Organic growth was 2%. The positive currency translation effects of 6% in Q2/22 were mainly related to the U.S. dollar and Chinese yuan.

Sales in North America increased by 16% (organic growth: 3%) to €606 million (Q2/21: €522 million), strongly supported by U.S. Dollar-related currency translation effects. Sales in Europe increased by 4% (organic growth: 4%) to €658 million (Q2/21: €634 million). Sales in Asia-Pacific increased by 4% (organic growth: -4%) to €425 million (Q2/21: €409 million). Positive currency translation effects contributed to reported sales growth. Sales in Latin America/Africa increased by 9% (organic growth: 2%) to €207 million (Q2/21: €190 million). Sales for the Biosimilars business were €29 million.

EBIT1 decreased by 9% (-15%2 in constant currency) to €271 million (Q2/21: €298 million). The EBIT margin1 was 14.3% (Q2/21: 17.0%).

Fresenius Kabi EBIT by region

Fresenius Kabi confirms its FY/22 outlook and expects organic sales3 growth in a low-single-digit percentage range. Constant currency EBIT2,4 is expected to decline in a high-single- to low-double-digit percentage range. The sales and EBIT outlook ranges include expected COVID-19 effects and exclude the effects of the acquisitions Ivenix and mAbxience.

1 Before special items
2 Excluding Ivenix acquisition
3 FY/21 base: €7,193 million
4 FY/21 base: €1,153 million, before special items, FY/22 before special items

Fresenius Helios preliminary financial results
Sales increased by 7% (6% in constant currency) to €2,925 million (Q2/21: €2,738 million). Organic growth was 5%. Acquisitions contributed 1% to sales growth.

Sales of Helios Germany increased by 5% (organic growth: 4%) to €1,758 million (Q2/21: €1,675 million). Sales of Helios Spain increased by 8% (7% in constant currency) to €1,101 million (Q2/21: €1,020 million). Organic growth was 6%. Sales of Helios Fertility were €65 million (Q2/21: €42 million).

EBIT1 of Fresenius Helios increased by 2% (1% in constant currency) to €303 million (Q2/21: €298 million) with an EBIT margin1 of 10.4% (Q2/21: 10.9%).

EBIT of Helios Germany increased by 1% to €154 million (Q2/21: €152 million) with an EBIT margin of 8.8% (Q2/21: 9.1%). EBIT of Helios Spain increased by 1% (0% in constant currency) to €148 million (Q2/21: €147 million). The EBIT margin was 13.4% (Q2/21: 14.4%). EBIT1 of Helios Fertility was €7 million with an EBIT1 margin of 10.8% (Q2/21: €5 million).

Fresenius Helios confirms its FY/22 outlook and expects organic sales2 growth in a low- to mid-single-digit percentage range and constant currency EBIT3 growth in a mid-single-digit percentage range. The sales and EBIT outlook ranges include expected COVID-19 effects.

Fresenius Vamed preliminary financial results
Sales increased by 1% (1% in constant currency) to €562 million (Q2/21: €556 million). Organic growth was 1%.
Sales in the service business increased by 6% (6% in constant currency) to €417 million (Q2/21: €392 million). Sales in the project business decreased by 12% (-12% in constant currency) to €145 million (Q2/21: €164 million).
EBIT1 decreased by 31% to €11 million (Q2/21: €16 million) with an EBIT margin1 of 2.0% (Q2/21: 2.9%).
Order intake was €253 million (Q2/21: €713 million). As of June 30, 2022, order backlog was at €3,732 million (December 31, 2021: €3,473 million).

Fresenius Vamed confirms its FY/22 outlook and expects organic sales4 growth in a high-single to low-double-digit percentage range and constant currency EBIT5 to return to absolute pre-COVID-19 levels (FY/19: €134 million). The sales and EBIT outlook ranges include expected COVID-19 effects.

1 Before special items
2 FY/21 base: €10,891 million
3 FY/21 base: €1,127 million, before special items, FY/22 before special items
4 FY/21 base: €2,297 million
5 FY/21 base: €101 million, before special items; FY/22 before special items

Detailed financial results publication and Conference Call
As part of the publication of the preliminary results for Q2/2022, a conference call will be held on July 28, 2022 at 1:30 p.m. CEDT (7:30 a.m. EDT) replacing the originally planned call from August 2, 2022.

All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com/investors. Following the call, a replay will be available on our website.

On August 2, 2022, Fresenius will publish detailed Q2/22 and H1/22 financials.