Bevacizumab biosimilar (mAbxience)

Proposed Merger to create a Nasdaq-listed, clinical-stage biopharmaceutical company developing novel treatments targeting STAT3 to treat fibrosis-driven diseases Tvardi has recently completed an approximately $28 million private financing, which, together with Tvardi’s existing cash and Cara’s anticipated cash balance, is expected to fund the combined company into the second half of 2026 Tvardi anticipates reporting topline data in the second half of 2025 from two Phase 2 clinical programs utilizing its STAT3 inhibitor, TTI-101, including its lead program in idiopathic pulmonary fibrosis and its program in hepatocellular carcinoma Companies to host investor conference call and webcast today, December 18th, at 8:30am ET Dec. 18, 2024 -- Cara Therapeutics, Inc. (Nasdaq: CARA) and Tvardi Therapeutics, Inc. (“Tvardi”), a privately held, clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, today announced that the companies have entered into a definitive merger agreement to combine in an all-stock transaction (the “Merger”). Under the terms of the agreement, Tvardi will merge with a wholly owned subsidiary of Cara. Upon completion of the Merger, pre-Merger Cara Therapeutics stockholders are expected to own approximately 17.0% of the combined company and pre-Merger Tvardi Therapeutics investors are expected to own approximately 83.0% of the combined company, in each case, prior to adjustment from the issuance of the shares in the recently completed Tvardi financing and assuming Cara has net cash at closing of between $22.875 million and $23.125 million. The percentage of the combined company that pre-merger Cara stockholders and pre-merger Tvardi stockholders will own upon the closing of the merger is subject to further adjustment if Cara’s net cash balance falls outside of the range. Upon completion of the Merger, the combined company is expected to operate under the name Tvardi Therapeutics, Inc. and trade on Nasdaq under the ticker symbol “TVRD”. Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi Therapeutics, stated, “As we approach meaningful value inflection points next year, including two Phase 2 readouts of our lead program in idiopathic pulmonary fibrosis, followed by the readout in our hepatocellular carcinoma program, this merger, the recently completed financing, and becoming a publicly traded company give us access to the critical funding required to further advance our promising pipeline programs that address significant unmet needs. I am grateful to the Cara Board, leadership team, and shareholders who share our vision of Tvardi that is well-positioned to introduce effective, new treatment options to patients suffering from serious, chronic, fibrosis-driven diseases.” “We are very excited to enter into this merger agreement with Tvardi and combine our financial resources with their expertise in STAT3 inhibition,” added Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “Our management and our Board of Directors thoroughly explored numerous strategic alternatives and believe that this merger with Tvardi is in the best interests of our stockholders and provides them with the opportunity to meaningfully participate in a company treating fibrosis-driven diseases in an innovative way.” Tvardi has recently completed an approximately $28 million private financing from a syndicate of new and existing institutional investors. With the cash from both companies at closing and the proceeds of this financing, the combined company is expected to have sufficient cash to fund its operating expenses and capital expenditure requirements into the second half of 2026, past the anticipated Phase 2 readouts in the second half of 2025. KORSUVA/KAPRUVIA Asset Sale Concurrent with the entry into the merger agreement with Tvardi, Cara also entered into an asset purchase agreement with Vifor Fresenius Medical Care Renal Pharma, Ltd. (“CSL Vifor”), a company jointly owned by Fresenius Medical Care and by the CSL Vifor business unit of the CSL Group. Pursuant to such asset purchase agreement, at the consummation of the transaction, Cara will sell to CSL Vifor and CSL Vifor will acquire from Cara certain assets and rights to the development, manufacture and commercialization of Korsuva®/Kapruvia® (difelikefalin) as well as certain associated liabilities (the “Asset Disposition”) for a purchase price of $900,000 (subject to certain adjustments with respect to inventory). Additionally, pursuant to the Asset Purchase Agreement, at the consummation of the Asset Disposition, Cara has agreed to pay CSL Vifor $3,000,000 to compensate CSL Vifor for the estimated incremental future expenses to be incurred by CSL Vifor as a result of the transfer of the assets to be acquired and the liabilities to be assumed by it in connection with the Asset Disposition. The Asset Disposition is subject to certain conditions to closing, including the consummation of the merger with Tvardi substantially contemporaneously with the Asset Disposition. Tvardi’s Pipeline of STAT3 Inhibitors The combined company will focus on advancing Tvardi’s pipeline of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need, including its lead candidate, TTI-101, which is in a Phase 2 trial for idiopathic pulmonary fibrosis (IPF) and a Phase 1b/2 trial for hepatocellular carcinoma (HCC). STAT3 is a highly validated, yet historically undruggable, transcription factor, which is a central catalyst in fibrosis-driven diseases. TTI-101 is an orally bioavailable, small-molecule inhibitor of signal transducer and activator of transcription 3 (STAT3), a transcription factor whose upregulation and activation acts as a catalyst across critical pathways associated with fibrosis-driven diseases. TTI-101’s differentiated mechanism of action is designed to inhibit STAT3 to address the unmet need in fibrosis-driven diseases, without interfering with its other essential biological functions. TTI-101 has shown a robust pharmacokinetic profile, potency in inhibiting STAT3 activation and efficacy in animal models of fibrosis-driven diseases. In addition, in clinical trials performed to date, oral dosing with TTI-101 lowered levels of activated STAT3 in tumor tissue, was generally well-tolerated, and led to clinical responses in HCC and other tumor types. The REVERTIPF ongoing clinical trial is evaluating the safety and efficacy of TTI-101 alone or in addition to nintedanib (OFEV®) in patients suffering from IPF. The clinical trial is testing two different doses of TTI-101 compared to placebo using a Phase 2, randomized, double-blind, placebo-controlled design and is being conducted in the United States. Unblinded data from the REVERTIPF study is anticipated to be reported in the second half of 2025. ClinicalTrials.gov ID: NCT05671835 The REVERTLIVER CANCER ongoing clinical trial is evaluating the safety and efficacy of TTI-101 across three cohorts of patients with HCC: alone or in combination with standard of care treatments pembrolizumab (Keytruda®) or atezolizumab (Tecentriq®) and bevacizumab (Avastin® or biosimilars Vegzelma®, Alymsys®, Zirabev®, and Mvasi®). The clinical trial is a Phase 1b/2 open-label study design being conducted in the United States. Preliminary topline data from the REVERTLIVER CANCER study is anticipated in the second half of 2025. ClinicalTrials.gov ID: NCT05440708 TTI-109, Tvardi’s second product candidate, is an oral, small-molecule, which is structurally related to, yet chemically distinct from, TTI-101 and is designed to enhance the ability to target STAT3. An IND application for TTI-109’s first human study is expected in the first half of 2025. Following the Merger, the combined company will be headquartered in Houston, Texas, and will be led by Tvardi’s CEO, Imran Alibhai, Ph.D., and other members of the Tvardi management team. The combined company's board of directors will be comprised of six directors from Tvardi’s Board of Directors and one director from Cara’s Board of Directors. The transaction has been approved by the Boards of Directors of both companies and is expected to close in the first half of 2025, subject to certain closing conditions, including, among other things, approval by the stockholders of each company, the effectiveness of a registration statement to be filed with the SEC to register the shares of Tvardi common stock to be issued in connection with the Merger, Cara having a minimum amount of net cash as of the closing, and other customary closing conditions. In connection with the Merger, directors and officers of Cara and directors, officers and certain stockholders of Tvardi have executed support agreements, pursuant to which they have agreed to vote all their shares of capital stock in favor of the Merger. Tvardi is a privately held, clinical-stage, biopharmaceutical company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need: idiopathic pulmonary fibrosis (NCT05671835) and hepatocellular carcinoma (NCT05440708). To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter). Cara Therapeutics is a development-stage biopharmaceutical company that was leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company developed an IV formulation of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. In connection with the proposed transaction between Cara and Tvardi, Cara intends to file relevant materials with the SEC, including a registration statement on Form S-4 that will contain a proxy statement and prospectus. CARA URGES INVESTORS AND STOCKHOLDERS TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT CARA, TVARDI, THE PROPOSED TRANSACTION AND RELATED MATTERS. Stockholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Cara with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. In addition, stockholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Cara with the SEC by contacting Investor Relations by email at investor@caratherapeutics.com. Stockholders are urged to read the proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. Cara and Tvardi, and each of their respective directors and executive officers and certain of their other members of management and employees, may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about Cara’s directors and executive officers, consisting of Helen M. Boudreau, Jeffrey L. Ives, Ph.D., Christopher Posner, Susan Shiff, Ph.D., Martin Vogelbaum, Lisa von Moltke, M.D., Ryan Maynard and Scott Terrillion, including a description of their interests in Cara, by security holdings or otherwise, can be found under the captions, “Security Ownership of Certain Beneficial Owners and Management,” “Executive Compensation” and “Director Compensation” contained in the definitive proxy statement on Schedule 14A for Cara’s 2024 annual meeting of stockholders, filed with the SEC on April 22, 2024 (the “2024 Cara Proxy Statement”). To the extent that Cara’s directors and executive officers and their respective affiliates have acquired or disposed of security holdings since the applicable “as of” date disclosed in the 2024 Cara Proxy Statement, such transactions have been or will be reflected on Statements of Change in Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the persons who may be deemed participants in the proxy solicitation, including the information about the directors and executive officers of Tvardi, and a description of their direct and indirect interests, by security holdings or otherwise, will also be included in a registration statement filed on Form S-4 that will contain a proxy statement (and prospectus and other relevant materials) to be filed with the SEC when they become available. Investors should read the registration statement, proxy statement/prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. These documents can be obtained free of charge from the sources indicated above. The content above comes from the network. if any infringement, please contact us to modify.

Contact Stefan Schmidt T +49 (0) 175 45 43 556 stefan.schmidt@fresenius.com Documents Text as PDF document (PDF, 248 KB) Group organic revenue growth of 9% 1,2 to €5.3 billion 2 driven by a strong Kabi performance and good organic growth at Helios. Strong bottom-line traction with Group EBIT 2 increase in constant currency of 9% 3 to €552 million and EPS growth of 7% 2,3,4 Group outlook for fiscal 2024 upgraded ; Organic revenue growth 1,2 is now expected to grow between 6% to 8% (previous: between 4% to 7%) and EBIT growth 2 in constant currency is now targeted to be in the 8 to 11% range (previous: between 6% to 10%). Group-wide cost and productivity savings ahead of plan with target for FY/24 already achieved YTD. Excellent operating cash flow resulting from focused cash management. Deleveraging continued, and leverage ratio further improved to 3.24x 2,5 driven by excellent cash flow; Leverage target corridor under review. Fresenius Kabi delivering above the top-end of the structural growth band with organic revenue growth of 11% 1 ; strong EBIT margin at 15.9% 2 . Growth Vectors at Kabi show continued strong performance , led by dynamic growth at Biopharma , which had yet again positive EBIT in Q3. Tyenne is in line with expectations, building on strong momentum. Fresenius Helios with excellent organic revenue growth of 8% driven by solid performance in Spain and supported by some favorable technical reclassifications in Germany; EBIT margin of 7.9% 2 in line with expectations due to anticipated lower seasonal demand in Spain; last quarter of energy relief funding support. Dedicated Helios performance program underway to drive further operational excellence and compensate ending energy relief funding in Germany. 1 Organic growth rate adjusted for accounting effects related to Argentina hyperinflation. 2 Before special items 3 Growth rate adjusted for Argentina hyperinflation 4 Excluding Fresenius Medical Care 5 At average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures, including lease liabilities, including Fresenius Medical Care dividend Michael Sen, CEO of Fresenius : "Team Fresenius delivered an excellent third quarter in 2024 – all financial metrics improved versus the prior year. Revenues grew strongly, with margin expansion across the Group, and significantly improved cash flow generation. Both Kabi and Helios continue to deliver consistent and sustained financial performance. We are more focused and stronger, deploying our cash to reduce debt further, while growing earnings per share and driving shareholder returns. Quarter after quarter we are showing how our #FutureFresenius strategy is paying off. Our mission remains at the core of our activities: saving and improving human lives. Fresenius is: Committed to Life.” Sen continued, “Given the strength of our first nine months, we are upgrading our revenue and earnings guidance for the year.” Group sales and earnings development Group revenue before special items increased by 7% (9% in constant currency) to €5,303 million (Q3/23: €4,967 million). Organic growth was 9% 2 , driven by Kabi and Helios' ongoing strong performance. Currency translation had a negative effect of 2% on revenue growth. Group EBITDA before special items increased by 4% (5% in constant currency) to €814 million (Q3/23: €783 million). Group EBIT before special items increased by 8% (9% in constant currency) to €552 million (Q3/23: €509 million), mainly driven by the strong organic revenue growth at Kabi and Helios and the continued progress of the groupwide cost savings program. The EBIT margin before special items was 10.4% (Q3/23: 10.2%). Reported Group EBIT was €492 million (Q3/23: €362 million). Group net interest before special items increased to -€116 million (Q3/23: -€102 million) mainly due to financing activities in a higher interest rate environment. Group tax rate before special items was 24.5% (Q3/23: 23.1%). 1 Before special items 2 Organic growth rate adjusted for accounting effects related to Argentina hyperinflation 3 Net income attributable to shareholders of Fresenius SE & Co. KGaA Constant currency growth rates adjusted for Argentina hyperinflation. Financial figures and growth rates adjusted for the divestment of the fertility services group Eugin and the hospital stake in Peru. Net income 1 from deconsolidated Fresenius Medical Care operations before special items increased by 38% (42% in constant currency) to €76 million (Q3/231: €55 million). Group net income 1 before special items increased by 12% (13% in constant currency) to €388 million (Q3/23 1 : €347 million). The increase was driven by operating strength. Reported Group net income 1 increased to €326 million (Q3/231: -€406 million) mainly due to Fresenius Medical Care's positive net income contribution. The negative net income in the prior year period was due to the non-cash valuation effect of Fresenius Medical Care in accordance with IFRS 5. Group net income 1 before special items excluding Medical Care increased by 7% (7% in constant currency) to €312 million (Q3/23 1 : €292 million). Earnings per share 1 before special items increased by 12% (13% in constant currency) to €0.69 (Q3/23 1 : €0.62). Reported earnings per share 1 were €0.58 (Q3/23 1 : -€0.72). Group Cash flow development Group operating cash flow (continuing operations) increased to €763 million (Q3/23: €603 million) mainly driven by the very good operational business development and improvements in working capital at Helios and Kabi. Group operating cash flow margin was 14.4% (Q3/23: 12.1%). Before acquisitions, dividends and lease liabilities, free cash flow (continuing operations) increased to €532 million (Q3/23: €346 million). After acquisitions, dividends and lease liabilities, free cash flow (continuing operations) improved to €623 million (Q3/23: €102 million). 1 Net income attributable to shareholders of Fresenius SE & Co. KGaA Constant currency growth rates adjusted for Argentina hyperinflation. Financial figures and growth rates adjusted for the divestment of the fertility services group Eugin and the hospital stake in Peru. For a detailed overview of special items please see the reconciliation tables at Financial Results | FSE (fresenius.com) Group leverage Group debt decreased by -16% (-16% in constant currency) to €13,317 million (Dec. 31, 2023: € 15,830 million) mainly related to the repayment of debt based on the excellent cash flow development and the around €400 million reduction of the leasing liabilities related to the Vamed exit. Group net debt decreased by -11% (-11% in constant currency) to € 11,823 million (Dec. 31, 2023: € 13,268 million). As of September 30, 2024, the net debt/EBITDA ratio was 3.24x 1,2 (Dec. 31, 2023: 3.76x 1,2 ) corresponding to a reduction of 52 bps compared to Dec. 31, 2023. This achievement is due to a combination of better EBITDA and Free cash flow. The legally required suspension of dividend payments and the Vamed exit further supported the positive development. Compared to Q3/23 (4.03x 1,2 ) this is a 79 bps reduction. Fresenius anticipates improving net debt/EBITDA ratio further 3 towards the lower end of the self-imposed corridor of 3.0 to 3.5x by year-end 2024. This is expected to be driven by further reducing net debt and operational performance of the Operating Companies. Structural productivity improvements: Target achieved ahead of plan The Group-wide cost and efficiency measures are progressing faster than planned. The target for annual sustainable cost savings of ~€400 million at EBIT level has already been achieved with accumulative savings totaling €408 million until the end of Q3/24. Originally, it was expected to achieve the target by year-end 2025. Fresenius will continue its efforts to increase structural productivity. So far, Kabi has delivered the majority of the savings. Going forward, it will be Fresenius Helios with its dedicated efficiency program focused on operations excellence including reduction of process and waiting times and digitalization of processes, resource optimization and synergies in particular in logistics and procurement. An update will be provided as part of the FY/24 results in February 2025. Further efforts to enhance structural efficiency will, however, also be driven forward by Fresenius Kabi and the Corporate Center. Key elements include measures to reduce complexity, optimize supply chains and improve procurement processes. 1 At average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures, including lease liabilities, including Fresenius Medical Care dividend 2 Before special items 3 At expected average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures; excluding further potential acquisitions/divestitures; before special items; including lease liabilities, including Fresenius Medical Care dividend For a detailed overview of special items please see the reconciliation tables at Financial Results | FSE (fresenius.com) Operating Company Fresenius Kabi Revenue increased by 5% (10% constant currency) to €2,114 million (Q3/23: €2,021 million). Organic growth was 11% 1 . This performance was driven by positive pricing effects, particularly in Argentina, and the excellent operating performance of the Growth Vectors. Revenue of the Growth Vectors (MedTech, Nutrition and Biopharma) increased by 9% (16% in constant currency) to €1,158 million (Q3/23: €1,067 million). Organic growth was excellent at 16% 1 . In Nutrition, organic growth of 11% 1 benefited from positive pricing effects in Argentina and the good development in the US, driven by the ongoing roll-out of lipid emulsions. China continued to be impacted by a general economic weakness, price declines in connection with tenders, and indirect effects of the government’s countrywide anti-corruption campaign. Biopharma showed excellent organic growth of 66% 1 driven by the overall good Biosimilars rollout in Europe and the U.S., with Tyenne standing out. Moreover, mAbxience also performed strongly, driven by bevacizumab and milestone payments. In MedTech, organic growth was of 7% 1 driven by a broad-based positive development in the US, Europe and International, reflecting strong performances for infusion and nutrition systems. 1 Organic growth rate adjusted for accounting effects related to Argentina hyperinflation. 2 Before special items Constant currency growth rates adjusted for Argentina hyperinflation. For a detailed overview of special items please see the reconciliation tables at Financial Results | FSE (fresenius.com) Revenue in the Pharma (IV Drugs & Fluids) business increased by 2% (3% in constant currency; organic growth: 6% 1 ) and amounted to €957 million (Q3/23: €941 million). Organic growth was mainly driven by a strong performance in Europe and International and solid growth in the U.S., driven by an improved backorder situation, compensating the softer development in China. EBIT 2 of Fresenius Kabi increased by 16% (16% in constant currency) to €335 million (Q3/23: €289 million) mainly due to the good revenue development, the positive EBIT result of the Biopharma business, and ongoing progress of the cost saving initiatives. EBIT margin 2 was 15.9% (Q3/23: 14.3%) and thus at the upper end of 2024 outlook. EBIT 2 of the Growth Vectors increased by 62% (constant currency: 53%) to €168 million (Q3/23: €104 million) due to the positive EBIT of the Biopharma business and the good revenue development. EBIT margin 2 was 14.5% (Q3/23: 9.8%). The Biopharma business is now expected to be EBIT break-even also in the FY/24. EBIT 2 in the Pharma business decreased by -9% (constant currency: -8%) to €182 million (Q3/23: €200 million) primarily driven by additional costs due to the start of production at the main US plants in Wilson and Melrose Park. EBIT margin 2 was 19.0% (Q3/23: 21.3%). Operating Company Fresenius Helios Revenue before special items increased by 8% (8% in constant currency) to €3,082 million (Q3/23: €2,863 million). Organic growth was 8%. Revenue of Helios Germany increased by 8% (in constant currency: 8%) to €1,940 million (Q3/23: €1,800 million) due to pricing effects coupled with volume growth and supported by some favourable technical reclassifications. Organic growth was 8%. Revenue of Helios Spain before special items increased by 8% (8% in constant currency) to €1,142 million (Q3/23: €1,062 million) driven by solid activity levels despite the anticipated lower seasonal demand, and favourable price effects. Organic growth was 8%. The clinics in Latin America also showed a good performance, additionally supported by currency exchange rate effects. EBIT 1 of Fresenius Helios increased by 7% (6% in constant currency) to €244 million (Q3/23: €229 million) with an EBIT margin 1 of 7.9% (Q3/23: 8.0%). EBIT 1 of Helios Germany increased by 8% to €170 million (Q3/23: €157 million) with an EBIT margin 1 of 8.8% (Q3/23: 8.7%). Q3/24 marked the last quarter in which energy relief funding was recognized in the income statement supporting profitability. EBIT 1 of Helios Spain decreased by -3% (0% in constant currency) to €73 million (Q3/23: €75 million) due to the expected seasonal softness and some phasing effects. The EBIT margin 1 was 6.4% (Q3/23: 7.1%). On a more comparable nine-months basis, the EBIT margin 1 was 11.2% (Q1-3/23: 11.2%). 1 Organic growth rate adjusted for accounting effects related to Argentina hyperinflation. 2 Before special items Constant currency growth rates adjusted for Argentina hyperinflation. 3 Before special items Financial figures and growth rates adjusted for the divestment of the fertility services group Eugin and the hospital stake in Peru. For a detailed overview of special items please see the reconciliation tables at Financial Results | FSE (fresenius.com) Implications of the Fresenius Vamed exit As of Q2 2024, Vamed is no longer a reporting segment of Fresenius. The company’s High-End-Services (HES) which offers services for Fresenius Helios and other hospitals, is included under Corporate / Other in the Group consolidated segment reporting. In Q1-3/24, the divestment of the rehabilitation business and the Vamed operations in Austria led to non-cash special items of €406 million at Group net income level. Special items related to the gradual scale back of the international project business amounted to €441 million at Group EBIT level in Q1-3/24, and to €357 million 1 at Group net income level. A total amount of high triple-digit million euros of special items is expected, which is spread over the next few years and will be mostly cash-effective. Group and segment outlook for 2024 2 Fresenius upgrades its outlook for FY/24. Based on the excellent first nine months of 2024, Group organic revenue growth 3,5,6 is now expected to grow between 6% to 8% (previous: between 4% to 7%) in 2024 and Group constant currency EBIT 4,5 is anticipated to grow in an 8% to 11% range (previous: between 6% to 10%). Fresenius Kabi expects organic revenue growth 6 in a mid-to high-single-digit percentage range in 2024. The EBIT margin 5 is expected to be in a range of 15% to 16% (structural margin band: 14% to 17%). Fresenius Helios expects organic revenue 5 to grow in mid-single digit percentage range in 2024. The EBIT margin 5 is expected to be within 10% to 11% (structural margin band: 10% to 12%). The Group outlook is given without Fresenius Vamed, i.e. exclusively for the Operating Companies Fresenius Kabi and Fresenius Helios. 1 According to ownership share 2 For the prior-year basis please see table “Basis for Guidance for 2024” 3 2023 base: €20,307 million 4 2023 base: €2,266 million 5 Before special items 6 Organic growth rate adjusted for accounting effects related to Argentina hyperinflation Basis for Guidance for 2024 # # # If no timeframe is specified, information refers to Q3/2024. An overview of the results for Q3/2024 - before and after special items – is available on our website. Consolidated results for Q3/24 as well as for Q3/23 include special items. These concern: divestment of the fertility services group Eugin and the hospital stake in Peru, Vamed exit,  expenses associated with the Fresenius cost and efficiency program, transaction costs for mAbxience and Ivenix, costs in relation to the change of legal form of Fresenius Medical Care, legacy portfolio adjustments, IT transformation, transformation/exit Vamed, discontinued operations Vamed, special items at Fresenius Medical Care, and impact of PPA due to the application of the equity method to the Fresenius Medical Care investment. The special items shown within the reconciliation tables are reported in the Corporate/Other segment. Note on the deconsolidation of Fresenius Medical Care Following the deconsolidation of Fresenius Medical Care, Group financial figures are presented in accordance with IAS 28 (at equity method) since December 1, 2023. The proportionate share of 32% of Fresenius Medical Care is presented as a separate line in Fresenius Group’s P&L and balance sheet. Dividends received from Fresenius Medical Care are reported as a separate line as part of the cash flow statement. Moreover, IAS 28 requires a full purchase price allocation (PPA). The accounting for the PPA is treated as special item. For reasons of simplification and comparability, Fresenius presents net income with and without Fresenius Medical Care`s equity result. Note on the portfolio optimization at Fresenius Helios As part of the portfolio optimization, the sale of the fertility services group Eugin was completed on January 31, 2024. The divestment of the majority stake in the hospital Clínica Ricardo Palma hospital in Lima, Peru, was completed on April 23, 2024. Therefore, results of Fresenius Helios and accordingly of the Fresenius Group for Q3/24 and Q3/23 are adjusted. Note on the growth rates Fresenius Kabi Growth rates in constant currency of Fresenius Kabi are adjusted. Adjustments relate to the hyperinflation in Argentina. Accordingly, in constant currency growth rates of the Fresenius Group are also adjusted. Note on the Vamed exit Due to the application of IFRS 5, the prior year and prior quarter figures of the current year have been adjusted in the consolidated statement of income and the consolidated statement of cash flows. Vamed’s High-End-Services (HES) which offers services for Fresenius Helios and other hospitals, will be transferred to Fresenius and is included under Corporate / Other in the Group consolidated segment reporting. Details on the financial and accounting implications of the Vamed exit and the portfolio adjustments at Fresenius Helios are available on our website. Information on the performance indicators are available on our website at https://www.fresenius.com/alternative-performance-measures .