On July 28, 2022 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported its half year 2022 financial results and provided a second quarter business update (Press release, argenx, JUL 28, 2022, View Source [SID1234617066]).

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"We had a strong second quarter of our global VYVGART launch reflecting the significant need for effective, safe treatment options for people living with generalized myasthenia gravis and the unwavering commitment of our team to deliver our innovation to patients around the world. We are still in the early stages of our first commercial launch, but are encouraged by the initial clinical interest in our first-in-class FcRn blocker and the feedback we are hearing from patients and their supporters," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "Based on our two positive Phase 3 data readouts already in 2022 and our plan to be active in 12 autoimmune indications by the end of the year across both efgartigimod and ARGX-117, we are confident that we are only at the beginning of our quest to transform the treatment of autoimmune disease."

SECOND QUARTER 2022 AND RECENT BUSINESS UPDATE

VYVGART Launch Progress
VYVGART is the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S. and Japan. VYVGART is approved in the U.S. for the treatment of adult generalized myasthenia gravis (gMG) patients who are anti-acetylcholine receptor (AChR) antibody positive and in Japan for adult gMG patients. The global launch strategy is on track to make VYVGART available in Europe, China and Canada, as well as select additional regions.

Generated global net product revenues of $75 million for second quarter of VYVGART commercial launch in U.S. and Japan
European Commission (EC) approval expected in third quarter 2022 following positive recommendation from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
Zai Lab and Medison filed for approval in China and Israel, respectively
Entered into VYVGART commercial and distribution agreement with Medison in Central and Eastern Europe
Efgartigimod Research and Development
argenx is positioned to expand its leadership position in FcRn blockade to include ten total autoimmune indications by the end of 2022, including registrational trials in six indications and proof-of-concept trials in four indications across multiple therapeutic franchises.

Neuromuscular franchise
BLA for SC efgartigimod for gMG on track to be filed by end of 2022
Topline data from registrational ADHERE trial of SC efgartigimod for chronic inflammatory demyelinating polyneuropathy (CIDP) expected in first quarter of 2023
Registrational ALKIVIA trial of SC efgartigimod on track to start in third quarter of 2022 for three subtypes of idiopathic inflammatory myopathies (myositis), including immune-mediated necrotizing myopathy, anti-synthetase syndrome and dermatomyositis; interim analysis planned of first 30 patients of each subtype
Hematology franchise
Enrollment expanded in second registrational ADVANCE-SC trial of SC efgartigimod for primary immune thrombocytopenia (ITP) based on key learnings from positive ADVANCE-IV trial; topline data now expected in second half of 2023
Dermatology franchise
Topline data from registrational ADDRESS trial of SC efgartigimod for pemphigus vulgaris and foliaceus expected in second half of 2023
Registrational BALLAD trial ongoing of SC efgartigimod for bullous pemphigoid with interim analysis planned of first 40 patients
Proof-of-concept trials to launch in 2022 in collaboration with Zai Lab and IQVIA
Zai Lab to launch Phase 2 trials in lupus nephritis and membranous nephropathy with argenx to lead global registrational programs for each potential indication
IQVIA to launch Phase 2 trials in primary Sjogren’s syndrome and COVID-19-mediated postural orthostatic tachycardia syndrome (POTS)
Pipeline Progress
argenx is developing ARGX-117 and ARGX-119, which both have pipeline-in-a-product potential for multiple autoimmune indications.

ARGX-117 (C2 inhibitor)
Proof-of-concept ARDA trial ongoing to evaluate safety, tolerability, and potential dosing regimen in multifocal motor neuropathy (MMN)
Phase 2 proof-of-concept trial expected to start in 2022 for prevention of delayed graft function and/or allograft failure after kidney transplantation
ARGX-119 (muscle-specific kinase (MuSK) agonist)
Phase 1 dose-escalation trial in healthy volunteers expected to start after Clinical Trial Application filing in fourth quarter of 2022 with subsequent Phase 1b trial to assess early signal detection in patients

Creation of OncoVerity
argenx, the University of Colorado Anschutz Medical Campus and UCHealth created an asset-centric spin-off, OncoVerity, Inc., focused on optimizing and advancing the development of cusatuzumab, a novel anti-CD70 antibody, in acute myeloid leukemia (AML). OncoVerity will be an entity of co-creation, combining the extensive translational biology insights from Dr. Clayton Smith, M.D. from the University of Colorado with the experience from argenx on the CD70/CD27 pathway. OncoVerity is the fourth spin-off company from argenx’s Immunology Innovation Program.

Nomination of Camilla Sylvest as non-executive director to Board of Directors

Ms. Sylvest’s appointment is pending approval, which is expected to occur at an extraordinary general meeting of shareholders to be held in September 2022. She is the Executive Vice President of Commercial Strategy and Corporate Affairs at Novo Nordisk, where she has worked for 26 years.

SECOND QUARTER 2022 FINANCIAL RESULTS

ARGENX SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENT OF PROFIT OR LOSS

Total operating income for the second quarter and year-to-date in 2022 was $85.2 million and $116.7 million, respectively, compared to $320.1 million and $498.6 million for the same periods in 2021, and consists of:

Product net sales from the sales of VYVGART for the three months ended June 30, 2022 were $74.8 million compared to $21.2 million for three month ended March 31, 2022, following the approval of VYVGART by the U.S. Food and Drug Administration (FDA) on December 17, 2021 and Pharmaceuticals and Medical Devices Agency (PMDA) in Japan on January 20, 2022. No product net sales were recognized during the same period in 2021.
Collaboration revenue for the second quarter and year-to-date in 2022 was $0.4 million and $2.6 million, respectively, compared to $312.2 million and $470.4 million for the same periods in 2021. The collaboration revenue for the three and six months ended June 30, 2021 was primarily attributable to the recognition of the transaction price as a consequence of the termination of the collaboration agreement with Janssen, resulting in the recognition of $311 million in collaboration revenue.
Other operating income for the second quarter and year-to-date in 2022 was $10.0 million, and $18.1 million, respectively, compared to $7.8 million and $28.2 million for the same periods in 2021. During the three months ended June 30, 2022, the fair value of the argenx profit share in AgomAb Therapeutics NV increased by $4.3 million. The increase is a result of the extension of a Series B financing round by AgomAb for which the Company maintains a profit share in exchange for granting the license for the use of HGF-mimetic antibodies from the SIMPLE Antibody platform.

Total operating expenses for the second quarter and year-to-date in 2022 were $259.7 million and $513.9 million, respectively, compared to $224.9 million and $403.5 million for the same periods in 2021, and consists of:

Cost of sales for the second quarter and year-to-date in 2022 was $5.0 million and $6.4 million, respectively. The cost of sales were recognized with respect to the sale of VYVGART during the first half of 2022. There were no cost of sales recognized in the comparable prior year periods.
Research and development expenses for the second quarter and year-to-date in 2022 were $126.9 million and $278.9 million, respectively, compared to $151.6 million and $273.9 million for the same periods in 2021. The research and development expenses mainly relate to external research and development expenses and personnel expenses incurred in the clinical development of efgartigimod in various indications and the expansion of our other clinical and preclinical pipeline candidates.
Selling, general and administrative expenses for the second quarter and year-to-date in 2022 were $127.8 million and $228.7 million, respectively, compared to $73.3 million and $129.6 million for the same periods in 2021. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the commercialization of VYVGART in the U.S. and Japan and personnel expenses.

Exchange losses for the second quarter and year-to-date in 2022 were $46.2 million and $53.4 million, respectively, compared to exchange gains of $10.4 million and exchange loss of $18.4 million for the same periods in 2021. Exchange losses are mainly attributable to unrealized exchange rate losses on our cash, cash equivalents and current financial assets position in Euro.

Income tax for the second quarter and year-to-date in 2022 was $8.2 million and $11.1 of tax income, respectively, compared to $1.7 million and $12.8 million of tax expense for the same periods in 2021. Tax income for the three months ended June 30, 2022 consists of $2.7 million of income tax expense and $10.9 million of deferred tax income, compared to $3.2 million of income tax expense and $1.5 million of deferred tax income for the same period in 2021.

Net loss for the second quarter and year-to-date in 2022 was $208.7 million and $435.9 million, respectively, compared to net profit of $103.6 million and $63.2 million for the same periods in 2021.

Cash, cash equivalents and current financial assets totaled $2,597.4 million as of June 30, 2022, compared to $2,336.7 million as of December 31, 2021. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering of shares, including a U.S. offering and a European private placement, which resulted in the receipt of $761.0 million in net proceeds in March 2022, partially offset by net cash flows used in operating activities.

FINANCIAL GUIDANCE
Based on current plans to fund anticipated operating expenses and capital expenditures, argenx continues to expect its 2022 cash burn to be up to $1 billion. This will support the global VYVGART launches, clinical development of efgartigimod in 10 indications and ARGX-117 in two indications, investment in the global supply chain, and continued focus on pipeline expansion through the Immunology Innovation Program.

EXPECTED 2022 FINANCIAL CALENDAR

October 27, 2022: Q3 2022 financial results and business update

CONFERENCE CALL DETAILS
The half-year financial results and second quarter 2022 business update will be discussed during a conference call and webcast presentation today at 2:30 pm CEST/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website.

On July 28, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported its cash position as of June 30, 2022, and its revenues for the second quarter of 2022 (Press release, MaaT Pharma, JUL 28, 2022, View Source [SID1234617082]).

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"The second quarter of 2022 saw further progress in our pipeline and the achievement of a crucial milestone for MaaT Pharma. The announcement of data showing a satisfactory safety profile and robust engraftment for MaaT033, our second drug candidate, opens an attractive market opportunity to expand the development to a wider patient population as we focus on preventing complications in patients receiving allo-HSCT[2] and in haematological malignancies overall," said Hervé Affagard, CEO and co-founder of MaaT Pharma.

Second quarter operational and clinical highlights

Clinical development

In June 2022, the Company confirmed positive results from its Phase 1b study evaluating MaaT033, the Company’s second drug candidate, in blood cancer patients; the clinical trial was completed early due to promising interim results.
MaaT Pharma also indicated that preparations are on track for the upcoming Phase 2/3 trial to evaluate MaaT033’s efficacy in improving overall survival and preventing complications in patients with blood cancers receiving allogeneic hematopoietic stem cell transplantation; based on current plans, this study is expected to start in Q4 2022.
In Europe, MaaT013, the Company’s leading drug candidate, is currently being evaluated in two clinical trials launched in Q1 2022, which are moving forward according to the Company’s expected timelines:
Phase 3 open label, single arm trial for drug candidate MaaT013 in the treatment of acute Graft-versus-Host Disease: in addition to France, Germany, and Spain where the trial is ongoing, the Company has received regulatory approvals to start the clinical trial in Austria and Belgium. An interim review of preliminary data is expected in the first half of 2023.
Phase 2a trial, sponsored by AP-HP[3], evaluating MaaT013 in combination with immune checkpoint inhibitors for patients with melanoma, is ongoing.
In the US, interactions with the U.S. Food and Drug Administration (FDA) are ongoing regarding MaaT013, for which US development is currently on clinical hold.
Operational highlights

On May 31, 2022, MaaT Pharma held its annual general meeting. For further information, please visit: View Source
On June 7, 2022, the Company hosted its first virtual R&D Day conference, attended by 150 participants. The replay is accessible here: View Source
"Over the first half of 2022 we are proud to have delivered to our shareholders the operational and clinical milestones set out at the time of our IPO. Our cash position remains solid, providing us with a cash runway through Q3 2023 by which time we expect to have interim data from our Phase 3 trial of MaaT013, and the first patient treated with MaaT033 in a Phase 2/3," stated Siân Crouzet, CFO and COO of MaaT Pharma.

Cash position1

As of June 30, 2022, total cash and cash equivalents were EUR 38.4 million, as compared to EUR 41.1 million as of March 31, 2022, and EUR 43.3 million as of December 31, 2021. The net change in cash over the first half of 2022 was EUR 4.9 million, including EUR 2.7 million in bank loans from BNP Paribas and Caisse d’Epargne Rhone Alpes (CERA) received over the course of the second quarter of 2022. Additional draws down, up to 4.4 million euros, are expected to be made by the end of 2022 from existing facilities signed with CIC and Bpifrance. The Company believes it has sufficient cash to cover needs of the development programs up until the end of the third quarter of 2023.

Revenues in Q2 20221

MaaT Pharma reported revenues[4] from its compassionate access program of EUR 0.2 million for the quarter ended June 30, 2022, compared with EUR 0.3 million for the first quarter of 2022. Total revenues for the first half of 2022 amount to EUR 0.5 million compared with EUR 0.4 million for the first half of 2021. In 2021, revenues were invoiced as of February 2021 whereas in 2022 the Company benefits from a full 6 months of revenues.

Upcoming financial communication and investor conference participation

September 12-14, 2022 – C. Wainwright 24th Annual Global Investment Conference
September 15-16, 2022 – KBC Securities Life Sciences Conference
September 28, 2022 – 5th edition – Forum LPB Valeurs Régionales
September 29, 2022 – Half-year Results 2022*
October 6-7, 2022 – Investor Access Event
*Indicative calendar that may be subject to change.

[1] Unaudited data
[2] Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment of liquid tumors which affect approximately 22,000 patients every year in the 7 major markets
[3] AP-HP: Assistance Publique – Hôpitaux de Paris
[4] Revenues correspond to compensation invoiced in relation to the compassionate access program, as approved by the French National Drug Safety Agency (Agence Nationale de Sécurité du Médicament or ANSM).

On July 28, 2022 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported that further progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its Appendix 4C Cash Flow Report (attached) for the quarter ending 30 June 2022 (Press release, Amplia Therapeutics, JUL 28, 2022, View Source;[email protected] [SID1234617098]).

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Key Highlights from the Quarter
• Positive pre-IND meeting feedback received from US FDA;
• First site opened for recruitment in ACCENT Phase 2 clinical trial of AMP945 in pancreatic cancer;
• Significant progress in manufacturing and toxicology studies of AMP945.

Operations Update
During the Quarter, Amplia received positive pre-IND (Type B) feedback from the US FDA on the Company’s proposed development plans for its investigational focal adhesion kinase inhibitor, AMP945, in people with pancreatic cancer. The Company also sought FDA’s specific feedback on the design of its ACCENT clinical trial of AMP945 in first-line patients with advanced pancreatic cancer.

The FDA agreed that the available and planned pre-clinical data appear to support both the trial and a future marketing application in the proposed indication. The FDA advised that the design of the ACCENT trial, including selection of the first-line patient population and the proposed dose-escalation followed by a Simon 2-stage design, is generally acceptable. FDA also confirmed Amplia’s understanding that dose selection for the Simon 2 stage expansion phase of the trial should be based on a combined view of safety, efficacy, pharmacokinetics and pharmacodynamics across a wide range of doses.

Additionally, during the Quarter, ethics committee approval was received to conduct the trial and the first site for recruitment of patients to the ACCENT trial was opened at Monash Health in Victoria, Australia. Three additional sites are scheduled to be activated in late July/early August. Previously the Company had forecast that the first patient would be recruited to the trial in the second calendar quarter of 2022 but this target was not met, primarily due to a longer than expected timeline to finalise contracts and governance arrangements with the various clinical sites. These matters have now been resolved allowing the ACCENT trial to recruit patients as planned. In order to recover any delays caused by slower than expected clinical trial start-up, the Company is assessing additional sites, increased patient outreach options and is planning an acceleration of South Korean site activation.

The Company has continued to make progress towards the initiation of a Phase 2 clinical study in Idiopathic Pulmonary Fibrosis patients with completion of dosing in the enabling 3-month toxicology studies of AMP945. Draft reports from these studies are expected in August 2022 and the Company will inform the market of any material outcomes.

Manufacture of AMP945 drug substance for use in non-clinical and clinical studies was also conducted with higher than expected yields of AMP945 being obtained, reflecting improved manufacture process understanding. A manufacture process for AMP945 higher potency drug product capsules was also developed. By delivering doses with fewer capsules, patient convenience and adherence to clinical trial protocols will be enhanced. Ongoing stability studies of AMP945 drug substance and drug product also show that AMP945 remains within specification for extended periods of time, supporting a likely long product shelf-life.

In June, new data from preclinical studies was disclosed showing that AMP945 had comparable activity to OFEV, the current market leader in the treatment of idiopathic pulmonary fibrosis. The Company expects that this new information will encourage interest from both clinical investigators and patients.

After joining the Company in February 2021 as Director Operations, Dr Rhiannon Jones was promoted to Chief Operations Officer (COO) effective July 1, 2022. Dr Jones has been leading much of Amplia’s manufacturing activities and her promotion to this broader role is a reflection of Amplia’s growth into a more mature clinical-stage company.

Financial update
Amplia finished the June 2022 quarter with cash of $12.7 million (March 2022: $14.6 million).

During the quarter, the Company had net cash outflows of $1.8 million in relation to operating activities (March 2022: $2.3 million). Operating cashflows included outflows of:
• $0.3 million for staff and administration/corporate costs; and
• $1.2 million for research and development costs, which primarily related to toxicology studies, ACCENT trial clinical costs and manufacturing costs of AMP945 drug substance and product.

Research and development expenditure is forecast to increase in the coming quarters in line with the commencement of the Phase 2 clinical trial for AMP945, which is expected to commence recruitment in the coming weeks with the first patient expected to be dosed in July-August 2022.

Payments to Related Entities
In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C incorporates directors’ fees, salaries and superannuation. Total payments made for the quarter equals $102,230 and relate to payments to the CEO/Managing Director in line with Dr Lambert’s employment contract and payments to the Non-Executive Directors.

Outlook and future activities
In the coming quarter, the Company expects to report on recruitment progress in the ACCENT trial as well as updates on progression towards optimal dose selection. The Company also expects to receive draft study reports from 3-month toxicology studies and will report top-line outcomes from these studies. Work on Amplia’s second FAK inhibitor, AMP886, is ongoing and outcomes from preclinical and manufacturing development work will be provided when ongoing studies are completed.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On July 28, 2022 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported that it will report second quarter 2022 financial results on Thursday, August 4, 2022 (Press release, AVEO, JUL 28, 2022, View Source [SID1234617115]). AVEO’s management team will host a conference call and audio webcast at 4:30 p.m. ET on Thursday, August 4, 2022, to discuss the financial results and provide a business update.

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The call can be accessed by dialing (877) 423-9813 (U.S. and Canada) or (201) 689-8573 (international). The passcode for the conference call is 13730553. To access the live webcast, or the subsequent archived recording, please visit the Calendar of Events sub-section within the Investors section of the AVEO website at www.aveooncology.com.

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.

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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.