Evaluation the effect of adding Sevelamer to the standard treatment of aluminum phosphide poisoning patients, referred to Tehran's Luqman Hospital, a preliminary studyon mortalit

Start Date20 Mar 2024

Sponsor / Collaborator

Shahid Beheshti University of Medical Sciences

CTR20230498

/ CompletedPhase 1

一项在健康受试者中评价含钙的磷结合剂醋酸钙片和非含钙的磷结合剂碳酸司维拉姆片对德度司他片的药动学影响的单中心、随机、开放、三周期交叉的I期临床研究

[Translation] A single-center, randomized, open-label, three-period crossover phase I clinical study to evaluate the effects of calcium-containing phosphate binder calcium acetate tablets and non-calcium-containing phosphate binder sevelamer carbonate tablets on the pharmacokinetics of dedostat tablets in healthy subjects

主要目的：评估磷结合剂碳酸司维拉姆片和醋酸钙片对德度司他片药动学的影响。次要目的：观察受试者给予磷结合剂碳酸司维拉姆片和醋酸钙片与德度司他片的安全性。

[Translation]

Primary objective: To evaluate the effect of phosphate binders sevelamer carbonate tablets and calcium acetate tablets on the pharmacokinetics of depo-depo-depo-depo-depo-depo-depo-depo-depo-depo-de- ...

Start Date13 Jul 2023

Sponsor / Collaborator

Yiqiao Hunan Pharmaceuticals Co. Ltd.

100 Clinical Results associated with Sevelamer Carbonate

100 Translational Medicine associated with Sevelamer Carbonate

100 Patents (Medical) associated with Sevelamer Carbonate

254

Literatures (Medical) associated with Sevelamer Carbonate

01 May 2025·Clinical Journal of the American Society of Nephrology

Efficacy and Safety of Phosphate-Lowering Agents for Adult Patients with CKD Requiring Dialysis

Article

Author: Noma, Hisashi ; Hamano, Takayuki ; Mizukami, Aya ; Kimura, Hiroshi ; Yamada, Shunsuke ; Hasegawa, Takeshi ; Nishimoto, Masatoshi ; Fukagawa, Masafumi ; Nishiwaki, Hiroki ; Taniguchi, Masatomo ; Murashima, Miho ; Saito, Hirotaka

Key Points:

Sevelamer was associated with lower all-cause mortality compared with calcium-based agents.Sucroferric oxyhydroxide and tenapanor were estimated to rank high in lowering all-cause mortality compared with other phosphate-lowering agents.Sucroferric oxyhydroxide and lanthanum were associated with slower progression of coronary artery calcium score compared with calcium-based agents.

Background:

It is necessary to update the evidence of each phosphate-lowering agent on dialysis patients.

Methods:

From the CENTRAL, MEDLINE, Embase, and ClinicalTrial.gov databases, randomized controlled trials using oral phosphate-lowering agents on adult patients requiring maintenance dialysis were extracted. The treatment period was required for 8 or more weeks, and the risk of bias was assessed according to the Cochrane Collaboration method. The outcomes were all-cause mortality, cardiovascular mortality, gastrointestinal events, fracture, coronary artery calcium score (CACS), serum calcium, phosphate, intact parathyroid hormone, and bicarbonate levels. A network meta-analyses using multivariate random-effects models were performed for assessing the comparative effectiveness. The ranking of the phosphate-lowering agents was assessed using a surface under the cumulative ranking curve.

Results:

A total of 70 randomized controlled trials involving 15,551 participants were included. Eleven phosphate-lowering agents including calcium-based agents, sevelamer, bixalomer, lanthanum, sucroferric oxyhydroxide, ferric citrate, tenapanor, magnesium, nicotinamide, aluminum, and sucralfate were assessed. Sevelamer was significantly associated with lower all-cause mortality compared with calcium-based agents (risk ratio [95% confidence interval]: 0.59 [0.37 to 0.94]), and sucroferric oxyhydroxide and tenapanor were estimated to rank high in lowering all-cause mortality on the basis of the surface under the cumulative ranking curve. The risk of gastrointestinal events was the highest with nicotinamide, followed by sucroferric oxyhydroxide. Compared with calcium-based agents, CACS was significantly lower among those on lanthanum and sucroferric oxyhydroxide (standardized mean difference [95% confidence interval]: −0.26 [−0.52 to −0.01] and −0.50 [−0.95 to−0.06], respectively). Serum calcium levels were higher, and serum intact parathyroid hormone levels were lower in patients treated with calcium-based agents. Except for sevelamer, serum bicarbonate levels for all other agents were higher compared with placebo.

Conclusions:

Compared with calcium-based agents, sevelamer was associated with lower all-cause mortality, and sucroferric oxyhydroxide and lanthanum were associated with slower progression of CACS. Potential benefits and harms should be considered when selecting phosphate-lowering agents (International prospective register of systematic reviews: CRD42022328388).

05 Apr 2025·Cureus Journal of Medical Science

Hyperphosphatemic Familial Tumoral Calcinosis With a Large Hip Mass

Article

Author: Ali, Issa ; Carlan, Steve ; Bernardes, Teresa ; Galili, Yehuda

Hyperphosphatemic familial tumoral calcinosis (HFTC) is a rare autosomal recessive disorder that generally presents in the first two decades of life with ectopic calcification throughout the body. The underlying metabolic disorder is caused by a mutation in a gene responsible for regulating fibroblast growth factor 23 (FGF23) activity. Loss of regulation of FGF23 results in hyperphosphatemia resulting in the characteristic tissue calcinosis deposits, especially in periarticular locations. The diagnosis is made with imaging, hyperphosphatemia, and genetic testing. Medical and surgical treatments are recommended to reduce blood phosphate and remove the masses. A 35-year-old male presented with a painful left lateral hip mass that had been gradually enlarging over the past four months. X-rays showed amorphous calcific densities in the left hip consistent with tumoral calcinosis. Magnetic resonance imaging (MRI) noted a stable complex mass in the left posterior hip and ischio-femoral space consistent with tumoral calcinosis. He had an elevated phosphorus level of 6.0 mg/dL (reference range 2.5 to 4.5 mg/dL). Excision of the mass was successful and genetic testing showed a pathogenic variant in polypeptide N-acetylgalactosaminyltransferase 3 (GALNT3), associated with HFTC. He was treated with diet and sevelamer (phosphate binder), and discharged. This case demonstrates that the detection of the disorder can be delayed by the slow progression of clinical symptoms and tumor calcinosis over time. Ultimately, early awareness of the disease and the mechanisms responsible for the tissue damage are important to limit long-term health consequences, which can include calcifications that ulcerate and limit joint motion. As seen in this patient, the condition often requires repeated surgical interventions. Finally, this is an autosomal recessive inherited disorder, so genetic counseling is an important component of comprehensive care.

01 Apr 2025·Kidney International Reports

A Pan-Inhibitor of Phosphate Transporters AP306 in Hemodialysis Patients

Article

Author: Wang, Yu ; Luo, Qun ; Shi, Ming ; Zuo, Li ; Zhang, Ping ; Li, Guisen ; Jiang, Hongli ; Chen, Menghua ; Liu, Yingxue Cathy ; Ma, Kunling ; Zhao, Qing ; Gu, Leyi ; Zhang, Weifeng ; Wang, Li ; Wang, Pei

Introduction:

Hyperphosphatemia in patients undergoing dialysis is not well-controlled. AP306 is a pan-inhibitor of phosphate transporters, designed to block the active uptake of phosphate through the gastrointestinal tract.

Methods:

In this phase 2 randomized, active-controlled, open-label study, hemodialysis patients with serum phosphate between 5.5 and 9.0 mg/dl were randomized to receive either AP306 or sevelamer carbonate for 12 weeks. The primary outcome was the change in serum phosphate levels from baseline until the therapy ceased. AP306 was initiated at 75 mg and adjusted stepwise to 125 mg and 150 mg orally thrice daily every 4 weeks, to maintain serum phosphate between 3.5 and 5.5 mg/dl. Sevelamer levels were adjusted using the same criteria and frequency.

Results:

A total of 27 patients were randomized to receive AP306 and 28 to receive sevelamer. At the end-of-treatment, both AP306 and sevelamer resulted in a significant decrease from baseline in serum phosphate by 2.51 mg/dl (95% confidence interval [CI]:-3.07 to -1.92; P < 0.001) and 1.08 mg/dl (95% CI: -1.58 to -0.59), respectively. The proportions of patients achieving the recommended range as per the Kidney Disease: Improving Global Outcomes guidelines (2.5-4.5 mg/dl) were about 20% higher in AP306 than in sevelamer, starting from treatment week 5. The most reported adverse events (AEs) associated with AP306 were gastrointestinal disorders (51.9%), most of which were mild to moderate diarrhea (44.4%).

Conclusion:

AP306 monotherapy significantly reduced serum phosphate levels and substantially improved the serum phosphate control rate in hemodialysis patients with hyperphosphatemia. AP306 was safe and well-tolerated.

News (Medical) associated with Sevelamer Carbonate

26 Jun 2025

·www.prnewswire.com

Alebund Announces Positive Topline Results from Pivotal Phase 3 Study of AP301 for Serum Phosphorus Control in Dialysis Patients with Hyperphosphatemia

SHANGHAI, June 26, 2025 /PRNewswire/ -- Alebund Pharmaceuticals ("Alebund" or the "Company"), an integrated biopharmaceutical company focusing on developing innovative therapies for renal diseases and related chronic conditions, announced the database lock was achieved on June 16, 2025 for the pivotal phase 3 study of its investigational drug AP301, a new generation of oral iron-based phosphate binder, in dialysis patients with hyperphosphatemia. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in serum phosphorus control with AP301. The safety profile of AP301 is favorable and consistent with previous studies. As a novel fiber-iron-based phosphate binder, AP301 provides high phosphate-binding capability, no need to chew before swallow, no volume expansion when exposed to gastric fluid, and no systemic absorption. These properties contribute to a reduced pill burden, good tolerability and improved patient compliance. The pivotal study (NCT07030595, CTR20231624) is a randomized, open-label, active-controlled, multi-center phase 3 study designed to evaluate the efficacy and safety of AP301 in controlling serum phosphorus levels in dialysis patients with hyperphosphatemia. The 52-week study contains an active control phase, an AP301 low-dose control phase and an extended treatment phase. Sevelamer carbonate served as the active comparator throughout the whole study period. A total of 474 participants were randomized across 50 investigational sites in China; the study was led by Professor Li ZUO, Director of the Department of Nephrology at Peking University People's Hospital. "We are deeply grateful to all the participants, investigators, and study personnel for their strong commitment and dedication to this phase 3 study over the past 2 years." Dr. Jin Tian, Co-founder and CMO of Alebund commented, "In the completed phase 2 study, AP301 was shown to be safe, well tolerated, and can effectively lower serum phosphorus in a dose-dependent manner [1]. This pivotal trial further demonstrates the clinical value of AP301, which has the potential to advance the treatment option for millions of patients with hyperphosphatemia through further increasing their adherence." Alebund plans to engage with China National Medical Products Administration (NMPA) regarding its new drug application plan in the third quarter of 2025. Detailed results from this phase 3 study will be presented at an upcoming medical conference. Reference [1] Bing Zhuang, Liangying Gan, Bin Liu, Weijie Yuan, Ming Shi, Ai Peng, Lihua Wang, Xiaolan Chen, Tongqiang Liu, Shiying Zhang, Song Wang, Qing Gao, Baoxing Wang, Huixiao Zheng, Changhua Liu, Yuan Luo, Hong Ye, Hongli Lin, Yiwen Li, Qiang He, Feng Zheng, Ping Luo, Gang Long, Wei Lu, Kanghui Li, Junwei Yang, Yingxue Cathy Liu, Zhizheng Zhang, Xiaoling Li, Weifeng Zhang, Li Zuo, Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis, Nephrology Dialysis Transplantation, Volume 39, Issue 10, October 2024, Pages 1649–1661, About Hyperphosphatemia Hyperphosphatemia is one of the most common complications in CKD patients. The long-term elevated serum phosphorus level could cause multiple complications such as secondary hyperparathyroidism, renal osteodystrophy and vascular calcification. It is an independent risk factor of cardiovascular events and all-cause mortalities. A good control of serum phosphorus level could effectively improve the patients' outcome. For CKD patients undergoing dialysis treatment, the regular dialysis is not sufficient to remove the overload of serum phosphate in the body. Considering the limitations of low-phosphate diet which might cause dystrophia, oral use of phosphate binders is the prevailing treatment for hyperphosphatemia. However, there is low compliance for patients (less than 50% reaching good phosphate control) to use PBs due to gastrointestinal side effects, high pill burden etc. According to Global and Chinese Hyperphosphatemia Drug Industry Blue Book by China Insights Consultancy in 2023, the out of target rate of serum phosphorus level in dialysis patients in Chinese mainland was significantly higher than other countries and regions. There is still room for improvement in terms of the proportion and duration of phosphorus binders usage. The market size of serum phosphorus lowering products in China is expected to reach 10 billion RMB by 2035. About Alebund Pharmaceuticals Alebund was incubated in Shanghai in 2018. It focuses on the discovery, development, production and commercialization of novel therapies primarily for kidney diseases and their complications, as well as other chronic conditions, to bring greater therapeutic options to patients in China and globally. Alebund has built a diversified and balanced pipeline of drug candidates targeting a range of renal indications, including chronic kidney disease (CKD)/dialysis complications, IgA nephropathy, diabetic kidney disease, focal segmental glomerulosclerosis (FSGS) and autosomal dominant polycystic kidney disease (ADPKD). Alebund has completed the construction of its manufacturing site for small molecules in Yangzhou that will supply bulk of Alebund's pipeline drugs, including AP301, upon commercial launch. Alebund has also established a dedicated commercialization team in China, responsible for the commercial promotion of renal products. SOURCE Alebund Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Phase 2

14 Oct 2024

·www.globenewswire.com

EUROAPI completes the financing of its FOCUS-27 plan and moves forward with its execution

€451M Revolving Credit Facility refinanced with a maturity extended to February 2029 Issuance of a €200M Perpetual Deeply Subordinated Hybrid Bond subscribed by Sanofi €54M product capacity reservation for five products and further amendments to the global Manufacturing and Supply Agreement (MSA) agreed with Sanofi “The completion of the financing is an instrumental step in the execution of EUROAPI’s strategic roadmap” said Ludwig de Mot, Chief Executive Officer. “Combined with further developments in our commercial relationship with Sanofi, it opens a new chapter for our company and all its stakeholders.” 10 October 2024 - EUROAPI announces today that it has completed and secured the financing of its FOCUS-27 strategic plan and agreed with Sanofi to further amend the Manufacturing and Supply Agreement signed in 2021. €451M Revolving Credit Facility refinanced with a maturity extended to February 2029 EUROAPI and its banking syndicate1 have agreed on a new secured €451 million Revolving Credit Facility (RCF), refinancing the existing revolving facility with a maturity in February 2029. Loans borrowed under the RCF will bear interest at an EURIBOR-indexed floating rate, plus an applicable margin2, as a function of EUROAPI’s Net Leverage Ratio, defined as Total Net Debt to Consolidated Core EBITDA3. The RCF will be subject to a covenant stipulating that the Net Leverage Ratio may not exceed 4.00x starting 30 June 2027 and a €50 million liquidity covenant applicable from signing until maturity. €200M Perpetual Deeply Subordinated Hybrid Bond subscribed by Sanofi Sanofi confirmed its support in the execution of the FOCUS-27 plan through an investment of €200 million in a Perpetual Deeply Subordinated Hybrid Bond. This non-dilutive instrument, which will be classified as “Equity” in EUROAPI’s consolidated financial statements, provides EUROAPI with additional financial flexibility to deliver its FOCUS-27 plan. On any interest payment date, EUROAPI may decide to defer and capitalize the interest payment, subject to certain conditions, including the absence of dividend payment or share repurchases. The hybrid bond will carry a 8.113% coupon until the first reset date, scheduled for February 2029. The closing of the revised RCF and the Perpetual Deeply Subordinated Hybrid Bond is expected before the end of October 2024 and will end the company’s collaboration with the mandataire ad hoc appointed in June 2024. €54M minimum available capacity reservation for five products agreed with Sanofi To support the implementation of FOCUS-27, Sanofi has agreed to reserve a minimum available capacity for five selected products manufactured by EUROAPI. Sanofi will pay €54 million, of which €18 million in H2 2024, and €36 million in 2025. These capacity reservations will secure revenue and increase the five products' overall performance4. In addition to the capacity reservation, Sanofi and EUROAPI have agreed on further amendments to the Global Manufacturing and Supply Agreement (MSA) signed in 2021, including secured volumes for Sevelamer, which will provide further visibility to Haverhill’s activity in the context of its divestment. These amendments, including the capacity reservation fees, are Regulated Agreements pursuant to the French Commercial Code. Details are available on EUROAPI’s website. EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities. Taking action for health by enabling access to essential therapies inspires our 3,650 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris; ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on LinkedIn. 1 BNP Paribas, Bank of America, JP Morgan, Crédit Agricole CIB, Société Générale, Deutsche Bank and Natixis 2 The margin will vary from 1.35% to 2.10% 3 Without taking into account the effects of IFRS 16 4 The €54 million capacity reservation is a financial consideration received (paid in H2 2024 and 2025) and will be recognized as revenue once the products are delivered as defined in the contract with Sanofi, mostly after 2027 The content above comes from the network. if any infringement, please contact us to modify.

Financial Statement

30 Jul 2024

·www.globenewswire.com

H1 2024 Results - Focus-27 strategic plan on track with timely execution of the operational roadmap

Press ReleaseParis, 30th July 2024 Net Sales down 9.6% year-on-year – Core EBITDA margin at 10.6%Accelerated commercial momentum with clients other than Sanofi, with Net Sales up 2.9%, excluding the Brindisi site, where production was temporarily suspendedEnhanced effectiveness across the entire organization, with sizeable improvements in industrial efficiencies€10 million Free Cash Flow before financing, driven by strengthened financial disciplineFY 2024 guidance confirmed " Our H1 actions set the foundations of our more agile, streamlined, and value-creating model. Over the past months, with the entire organization's support, we have made significant progress in deploying the four strategic pillars of our operational roadmap. Thanks to a comprehensive mitigation plan, we will resume shipment and production in Brindisi in the coming weeks." said Ludwig de Mot, Chief Executive Officer of EUROAPI. "Confident in the collective success of our plan, we are in advanced discussions with our stakeholders to finalize the financing of FOCUS-27 in the coming weeks, which will pave the way for long-term profitable growth.” €448.7 million in Net Sales, down by 9.6%1, shaped by the strong decrease in volumes from Sanofi and the suspension of production in Brindisi, which overshadowed the positive momentum of sales to clients other than Sanofi Brindisi GMP license reactivated mid-July; shipments and production to restart gradually during Q3 2024 Signature of a major CMO commercial phase contract with a global animal health company and a development and manufacturing agreement with Priothera, a biotechnology company specializing in oncology €47.6 million Core EBITDA, with a 10.6% Core EBITDA margin, down from 12.6% in H1 2023. Price increases and product mix, industrial efficiencies, and the impact of the revised commercial contractual clauses with Sanofi over the period partially offset the unfavorable fixed-cost absorption. €(1.4) million EBITDA, including €47.2 million exceptional costs related to the implementation of FOCUS-27. €(170.2) million Net Debt compared to €(171.0) million at the end of December 2023, with €10.0 million Free Cash Flow before financing, compared to €(111.2) million for the same period last year, driven notably by Controlled CAPEX (€61.3 million, of which 56% dedicated to growth) Improved Operating Working Capital thanks to a rigorous inventory reduction program and better cash collection €(34.8) million Net income, compared to €62.8 million in H1 2023 H1-2024 Key figures (in € millions)H1-2024H1-2023Net Sales448.7496.6Year-on-year change in %-9.6%+2.6%Gross profit98.097.0Gross Profit Margin21.8%19.5%EBITDA(1.4)52.1Core EBITDA47.662.5Core EBITDA Margin10.6%12.6%Net Income(34.8)62.8Basic EPS (in euros)(0.37)0.67 2024 outlook confirmed Between 8% and 11% decrease in 2024 Net Sales compared to 2023 on a comparable basis, with a second-half performance slightly exceeding that of the first half due to a phasing impact in CDMO. Core EBITDA margin objective expected between 4% and 7%. The positive impact in H1 of the revised contractual clauses with Sanofi will be lower in the second half. FOCUS-27 plan in action The execution of FOCUS-27 is on track, with several initiatives launched during the first half, and the discussions with the Revolving Credit Facility banking syndicate to finalize the financing announced on June 26, 2024, are in the advanced stage. Streamlined value-added portfolio List of the discontinued 13 APIs communicated to our clients; phase-out roadmap almost completedAccelerated momentum in Opiates, prompted by improving competitive positions Focused CDMO offer Solid and qualitative new late-stage projects with 3 marketed small molecules for large and mid-size pharma and food companies (including GMP intermediates). Increasing momentum in large molecules, with 5 early-stage projects in H1, mainly from large pharma companies, including 4 promising new oligonucleotides and 1 peptide-PMO conjugate project. Rationalized industrial footprint Ramp down of workshops initiated in Frankfurt (9 APIs to be discontinued), and Vertolaye (2 APIs to be discontinued)Inventory reduction program on track Haverhill divestment process well advanced; completion expected in 2025 Organizational transformation Headcount reduction plan initiated in Haverhill following the decrease in volumes of SevelamerContinued enhancement of the management teams across the group, including the reorganization of the Executive leadership team. H1-2024 Net Sales EUROAPI H1-2024 Net Sales reached €448.7 million, -9.6% versus H1 2023 and -9.3% at Constant Exchange Rates. Net sales per type of activity (in € millions)H1H1-2023ChangeAPI Solutions – Other clients168.6169.8-0.7%API Solutions – Sanofi163.7192.7-15.0%API Solutions332.4362.4-8.3%CDMO – Other clients72.382.7-12.7%CDMO – Sanofi44.151.4-14.2%CDMO116.4134.2-13.3%Net sales448.7496.6-9.6%Total Net Sales – Sanofi207.8244.1-14.9%Total Net Sales – Other clients 240.9252.5-4.6% API Solutions API Solutions' net sales decreased by 8.3% to €332.4 million. Sales to Sanofi decreased by 15.0% due to strong volume decrease, notably in Sevelamer, produced in Haverhill, and the suspension of production in Brindisi. H1 net sales include €29 million related to the revision of the historical MSA contractual clauses agreed with Sanofi in February 20242, primarily Buserelin’s3 stock clearance. Sales to Other Clients decreased by 0.7%, impacted by the temporary suspension of API production in Brindisi. Excluding Brindisi’s site, net sales would have grown 3.4%, driven by the cross-selling strategy (representing 9.1% of H1 API Solutions sales to Other Clients) and an increased customer base (22 new clients added in H1). CDMO CDMO sales decreased by 13.3% to €116.4 million. Sales to Sanofi decreased by 14.2% on the back of a strong H1 2023 performance, which was boosted by stock replenishment of Pristinamycin, an anti-infective produced exclusively for Sanofi in Elbeuf. H1 2024 sales benefited from the ramp-up of a commercial phase contract in Large Molecules.Sales to Other Clients decreased by 12.7% due to the temporary suspension of production in Brindisi, which affected a commercial phase contract. H1 2024 performance was also penalized by the downsizing of two large historical commercial phase contracts (approximately -10 M€), which more than offset the increase in revenue from new contracts. Excluding the impact of Brindisi, total CDMO sales to clients other than Sanofi would have grown by 1.8%, with increased revenues from early-stage projects. Throughout the semester, 14 new CDMO contracts were signed, and eight projects were completed, including two in late stage with Sanofi, and two projects were put on hold. (Number of CDMO projects)Phase 1 and earlierPhase 2Phase 3Commercial PhaseTotalLarge molecules742417Highly potent molecules1 12Biochemistry molecules derived from fermentation2 68Complex chemical synthesis molecules9772346Total191193473 Net Sales per type of molecule (in € million)H1-2024H1-2023ChangeLarge molecules58.835.0+67.9%Highly potent molecules47.143.7+7.8%Biochemistry molecules derived from fermentation43.785.5-48.8%Complex chemical synthesis molecules299.1332.4-10.0%Net Sales448.7496.6-9.6% Large molecules increased by 67.9% to €58.8 million, driven by the stock clearance of Buserelin, and the ramp-up of a commercial phase contract in Large Molecules with Sanofi. Highly potent molecules were up 7.8% to €47.1 million on the back of a low comparison base in H1 2023, which was impacted by the suspension of Prostaglandins’ production.Biochemistry molecules derived from fermentation decreased 48.8% to €43.7 million. While H1 2023 performance was boosted by stock replenishment of Pristinamycin, H1 2024 was impacted by the temporary suspension of API production in Brindisi. Complex chemical synthesis molecules decreased by 10.0% to €299.1 million, mainly impacted by the decreasing volume demand from Sanofi. Financial performance (in € million)H1-2024H1-2023Net Sales448.7496.6Other revenues2.21.9Gross profit98.097.0Gross Profit Margin21.8%19.5%EBITDA(1.4)52.1Non-recurring costs49.010.4Core EBITDA47.662.5Core EBITDA Margin10.6%12.6%Operating Income(33.4)16.0Finance revenues/costs(8.1)(3.3)Income before tax(41.5)12.6Income tax expense6.750.1Net income/(loss)(34.8)62.8EPS (in euros)(0.37)0.67Average number of shares outstanding (in millions)94.393.9Fully diluted EPS (in euros)(0.37)0.66Average number of shares after dilution (in millions)95.995.5 Gross profit was €98.0 million, compared to €97.0 million in H1 2023, with the gross profit margin up 231 basis points year-on-year to 21.8%. The exceptional impact of Buserelin’s stock clearance, positive price and mix effect, lower energy and raw materials prices, and improved industrial performance more than offset unfavorable fixed-cost absorption as we sold in H1 24 products manufactured at the peak level of the past 18 months inflation cycle. Core EBITDA amounted to €47.6 million, down 23.8% compared to €62.5 million in H1 2023. The core EBITDA margin was 10.6%, compared to 12.6% in H1 2023. The increase in OPEX was mostly driven by the company's transformation and reorganization. EBITDA was €(1.4) million compared to €52.1 million in H1 2023. The 49.0 million non-recurring costs include €47.2 million in exceptional items4, of which €33.8 million of idle costs5 linked to the execution of FOCUS-27, including the ramp-down of two workshops in Frankfurt started in H1 2024 and reduced inventories in Vertolaye €9.0 million of internal and external costs related to the transformation of the company €4.4 million of employee-related expenses, including redundancy plans. Key components of the change in Core EBITDA marginH124/H123 in percentage points (rounded figures)H1 2023 Core EBITDA margin12.6%Volume-0.0 ptsPrice and Mix+3.0 ptsImpact of Buserelin’s stock clearance+2.1 ptsIndustrial performance+2.4 ptsEnergy and Raw Materials+1.2 ptsUnfavorable fixed cost absorption-5.5 ptsOther Gross Margin impacts -1.9 ptsOPEX -2.9 ptsBrindisi site, including the impact of the suspension of production-0.3 ptsH1 2024 Core EBITDA margin10.6% Operating Income was €(33.4) million compared to €16.0 million in H1 2023. Financial income was €(8.1) million, compared with €(3.3) million in H1 2023, due notably to the increase in interest rates and the full drawdown of the RCF. Income before tax was €(41.5) million6. Net income was €(34.8) million in H1 2024. Net Debt Position and Cash Flow (in € million)30 June 2024Net cash/(Debt) position – December 2023(171.0)Cash Flow from Operating activities71.2Of which change in Working Capital66.1 (Increase)/decrease in inventories 4.1 (Increase)/decrease in trade receivables 40.0 Increase/(decrease) in trade payables (16.2) Other current assets and liabilities 38.3Cash Flow from Investing Activities(61.3)of which CAPEX(61.3)Cash Flow from Financing activities(8.3)Exchange rate((0.9)Net Cash/(Debt) position – June 2024(170.2) The decrease in Net Debt position, €(170.2) million compared to a €(171.0) million at the end of December 2023, was notably driven by Working Capital, including the improvement in inventories. Improved cash collection drove the change in Trade receivables, with DSO down to 53 compared to 56 in December 2023 and 70 in H1 2023. Other current assets and liabilities include a €27 million variation in VAT tax reimbursement. Capex reached €(61.3) million (13.7% of Net Sales), of which 56% were dedicated to growth projects, including increased capacities for Peptides and Oligonucleotides, Vitamin B12, and Prostaglandins. Free Cash Flow before financing activities was €10.0 million, compared to €(111.2) million at the end of June 2023.7 (in € million)30 June 202431 December 2023Bank Cash Balances282.834.5Revolving Credit Facilities(453.0)8(205.5)Net Debt Position(170.2)(171.0) Net Debt to Core EBITDA restated for IFRS 16 was 2.38x, below the RCF covenant of 4.0x.ESG Roadmap EUROAPI ESG roadmap is on track to achieve its 2030 goals and has recently achieved: 100% of its sites certified ISO14001 (environment management) and ISO50001 (energy management). CDP score B, which indicates that the group is addressing the environmental impacts of its business and ensures good environmental management. Main H1 2024 events On January 25, 2024, EUROAPI announced that it had initiated a pivotal collaboration with SpiroChem, a leading Contract Research Organization (CRO).On March 14, 2024, EUROAPI announced the pause of API production at the Brindisi site in Italy after identifying quality control deficiencies and decided to suspend its full-year 2024 guidance.On May 23, 2024, EUROAPI announced a Contract Manufacturing Organization (CMO) agreement with a global animal health company to supply key veterinary product. The total contract value is expected to range between €130 and 150 million over 2025-2029.On June 6, 2024, EUROAPI received official notification from the European Commission that it had been selected as one of the 13 companies eligible to share up to EUR 1 billion in total public funding under the Important Project of Common European Interest (IPCEI) dedicated to the pharmaceutical sector.On June 18, 2024, EUROAPI announced the implementation of a 5-year development and manufacturing agreement with Priothera, a biotechnology company specializing in treating hematological malignancies and improving CAR-T cell therapies.On June 26, 2024, EUROAPI detailed the FOCUS-27 strategy and announced its target to generate €75 million to €80 million annual run-rate incremental Core EBITDA by the end of 2027. More detail on EUROAPI’s website: EUROAPI is moving ahead with its FOCUS-27 plan, setting the foundations for future profitable growth | EUROAPIannounced that the Brindisi site will progressively resume shipments and production during Q3 2024. Glossary and definition of non-GAAP indicators EBITDA and Core EBITDA EBITDA corresponds to operating income (loss) restated for depreciation and amortization and net impairment of intangible assets and property, plant and equipment.Core EBITDA thus corresponds to EBITDA restated for restructuring costs and similar items (excluding depreciation and write-downs), allocations net of reversals of unutilized provisions for environmental risks, and other items not representative of the Group’s current operating performance or related to the effects of acquisitions or disposals. Cash Flow before Financing activities Cash Flow before Financing activities corresponds to the sum of Cash Flow from Operating Activities and Cash Flow from Investing Activities as presented in the consolidated statement of Cash Flow. Months on Hand (MOH) Net Inventory value at the of the period divided by Net Sales New clients Clients representing at least €50 thousands of net sales on the year. Cross Selling Selling a different product to an existing client that is already buying one or several products from EUROAPI. Early-stage and Late-stage projects Early-stage: pre-clinical, phase 1, and phase 2Late-stage: phase3, in validation, and commercial Presentation of H1-2024 results An analysts’ conference call will be held by EUROAPI’s management tomorrow (31 July 2024) at 8:30 a.m. CET via an audio webcast (live and replay), and the results presentation will be available on the corporate website 2024 Half year results | EUROAPI Financial agenda (all dates to be confirmed) 11 February 2025: FY 2024 Results21 May 2025: 2025 AGM29 July 2025: H1 2025 results About EUROAPIEUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities. Taking action for health by enabling access to essential therapies inspires our 3,650 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris; ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on LinkedIn. Media Relations contact:Laurence BollackTel.: +33 (0)6 81 86 80 19mr@euroapi.com Investor Relations contacts:Sophie Palliez-CapianTel.: +33 (0)6 87 89 33 51Sophie.palliez@euroapi.com Camille RicotierTel: +33 (0)6 43 29 93 79Camille.ricotier@euroapi.com Forward-Looking StatementsCertain information contained in this press release is forward looking and not historical data. These forward-looking statements are based on opinions, projections and current assumptions including, but not limited to, assumptions concerning the Group’s current and future strategy, financial and non-financial future results and the environment in which the Group operates, as well as events, operations, future services or product development and potential. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Forward looking statements and information do not constitute guarantees of future performances, and are subject to known or unknown risks, uncertainties and other factors, a large number of which are difficult to predict and generally outside the control of the Group, which could cause actual results, performances or achievements, or the results of the sector or other events, to differ materially from those described or suggested by these forward-looking statements. These risks and uncertainties include those that are indicated and detailed in Chapter 3 “Risk factors” of the Universal Registration Document filed with the French Financial Markets Authority (Autorité des marchés financiers, AMF) on April 5, 2024. These forward-looking statements are given only as of the date of this press release and the Group expressly declines any obligation or commitment to publish updates or corrections of the forward-looking statements included in this press release in order to reflect any change affecting the forecasts or events, conditions or circumstances on which these forward-looking statements are based. Appendix Consolidated Income Statement (in € millions)30-Jun-2430-Jun-23Net sales448.7 496.6 Other revenues2.2 1.9 Cost of sales(352.9)(401.4)Gross profit98.0 97.0 Selling and distribution expenses(18.7)(21.3)Research and development expenses(13.9)(13.3)Administrative and general expenses(46.6)(42.8)Other operating income1.3 0.7 Impairment of assets(3.9) Restructuring costs and similar items(49.7)(4.3)Operating income(33.4) 16.0 Financial expenses(11.2)(5.3)Financial income3.1 1.9 Income/(loss) before tax(41.5) 12.6 Income tax expense6.7 50.1 Net income/(loss)(34.8) 62.8 Number of shares outstandings94.393.9EPS(0.37)0.67Diluted number of shares 95.995.5EPS diluted(0.37)0.66 Consolidated Balance Sheet (in € millions)30-Jun-2431-Dec-23Goodwill4.6 4.6 Property, plant and equipment469.0 468.9Right-of-use assets35.2 37.2Intangible assets38.9 34.2Other non-current assets6.7 9.0Deferred tax assets85.7 79.2Non-current assets640.2633.1Inventories638.7 644.8Trade receivables176.7 216.3Other current assets57.5 83.7Cash and cash equivalents282.8 34.5Current assets1,155.8979.3Total assets1,795.91,612.4(in € millions)30-Jun-2431-Dec-23Equity attributable to owners of the parent889.5927.7Total equity889.5927.7Non-current lease liabilities14.515.5Provisions155.3158.6Other non-current liabilities0.00.0Deferred tax liabilities0.81.6Non-current liabilities170.6175.7Trade payables143.6159.6Other current liabilities135.1139.3Current lease liabilities4.34.6Short-term debt and other financial liabilities452.8205.4Current liabilities735.9508.9Total equity and liabilities1,795.91,612.4 Consolidated Statements of Cash Flow (in € millions)30-Jun-2430-Jun-23Net income / (loss)(34.8)(62.8)Depreciation & amortization 32.0 36.1 Net change in current & deferred taxes(6.7)(50.1)Other profit or loss items with no cash effect and reclass of interest 14.7 8.2 Operating cash flow before changes in working capital 5.1 56.9 (Increase)/decrease in inventories 4.1 (66.0)(Increase)/decrease in trade receivables 40.0 30.1 Increase/(decrease) in trade payables(16.2)(49.0)Net change in other current assets and other current liabilities 38.3 (10.3)Net cash provided by operating activities 71.2 (38.2) Acquisitions of property, plant and equipment and intangible assets(61.3)(73.1)Acquisition of shares on consolidated entities, net of cash acquired - Sales/Acquisitions to/from Group entities 0.0 - Net cash (used in) investing activities(61.3)(73.1)Capital increases - - Repayment of lease liabilities(2.7)(4.6)Net change in short-term debt 246.0 100.0 Finance costs paid(4.1)(2.0)Acquisitions and disposals of treasury shares(0.0)(0.2)Other net cash flow arising from financing activities(0.3)(0.0) Net cash provided by financing activities 238.8 93.2 Impact of exchange rates on cash and cash equivalents(0.5) 0.6 Net change in cash and cash equivalents 248.3 (17.5) Cash and cash equivalents at beginning of period 34.5 74.5 Cash and cash equivalents at end of period 282.8 57.0 Reconciliation of Consolidated Operating Income (EBIT) to restated Core EBITDA (in € millions)30-Jun-2430-Jun-23Operating income(33.4) 16.0 Depreciation and amortization 32.0 36.1 EBITDA(1.4) 52.1 Restructuring costs and similar items (excluding depreciation and amortization) 47.2 4.3 Of which idle costs33.8 Of which employee-related expenses4.4 Of which internal and external costs related to FOCUS-27, and transformation9.04.3Allocations net of reversals of unutilized provisions for environmental risks(0.2)(0.3)Other 2.0 6.3 Core EBITDA 47.6 62.5 Core EBITDA10.6%12.6% Idle costs are mainly affecting Vertolaye, with the inventory reduction program being the main business factor, as well as the discontinuation of 2 APIs, Frankfurt, with the decision to discontinue 9 APIs (the ramp down of two workshops has already started in 2024). Employee-related expenses of €4.4 million include the impact of the redundancy plan announced in EUROAPI UK and severance payments in connection with the renewal of the Executive leadership teams. Restructuring costs correspond to expenses incurred in connection with the transformation or reorganization of the EUROAPI Group’s operations and support functions. These costs include collective redundancy plans, compensation awarded to third parties for the early termination of contracts, commitments made in connection with transformation and reorganization decisions, and idle costs related to the temporary shutdown of sites or production lines associated with such programs.They also include accelerated depreciation charges arising from closures of production facilities (including leased facilities), and losses on any resulting asset disposals.In addition, restructuring costs and similar items comprise expenses (both internal and external)incurred in connection with FOCUS-27. 1 All comments in this press release are made compared to H1 2023 figures unless stated otherwise2 Full-year expected impact: €38 million (Regulated Agreement approved by the May 22nd AGM)3 Buserelin is a large molecule used primarily in the treatment of prostate cancer and endometriosis.4 See appendix page 13 5 Under-activity triggered by the implementation of FOCUS-27 6 H1 2023 income tax included €46.8m deferred tax income related to the revaluation of EUROAPI’s Hungarian assets.7 See detailed in Consolidated Cash Flow Statement page 128 RCF: €451 million + €2 million accrued interests Attachment EUROAPI - Press release - July 30, 2024

Financial StatementPhase 1

100 Deals associated with Sevelamer Carbonate

External Link

KEGG	Wiki	ATC	Drug Bank
D06642	Sevelamer Carbonate	V03AE02	DB00658

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Kidney Disease-Mineral and Bone Disorder	European Union	Sanofi Winthrop Industrie SA	15 Jan 2015
Chronic Kidney Disease-Mineral and Bone Disorder	Iceland	Sanofi Winthrop Industrie SA	15 Jan 2015
Chronic Kidney Disease-Mineral and Bone Disorder	Liechtenstein	Sanofi Winthrop Industrie SA	15 Jan 2015
Chronic Kidney Disease-Mineral and Bone Disorder	Norway	Sanofi Winthrop Industrie SA	15 Jan 2015
Hyperphosphatemia	European Union	Sanofi Winthrop Industrie SA	09 Jun 2009
Hyperphosphatemia	Iceland	Sanofi Winthrop Industrie SA	09 Jun 2009
Hyperphosphatemia	Liechtenstein	Sanofi Winthrop Industrie SA	09 Jun 2009
Hyperphosphatemia	Norway	Sanofi Winthrop Industrie SA	09 Jun 2009
Chronic Kidney Diseases	United States	Genzyme Corp.	19 Oct 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Kidney Failure, Chronic	Phase 3	France	Genzyme Corp.	01 Oct 2010
Hyperparathyroidism, Secondary	Phase 3	United States	Genzyme Corp.	01 Apr 2010
Cardiovascular Diseases	Phase 2	United Kingdom	Genzyme Corp.	01 Feb 2009
Diabetes Mellitus, Type 2	Clinical	Denmark	Sanofi	01 Feb 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04485039 (CTgov)	Phase 4	Smallpox	44	Tecovirimat (TPOXX: Oral Antiviral)	odnbzsbtwh(opcucprtri) = cksmywnqdl moyvzsxmdj (wlxrrxbozw, 39.6) View more	-	09 Oct 2024
				Tecovirimat+sevelamer carbonate oral tablet (TPOXX: Oral Antiviral and Sevelamer Carbonate)	payxfeltzi(ofpblywxfn) = nktkcsjlgw skknosomuw (vutkqlprfq, tlcedyoaov - jjgmeywrnn) View more
NCT03644264 (Pubmed)	Phase 3	Hyperphosphatemia	286	Sucroferric oxyhydroxide	nsxayojtld(ofznkmksxa) = ukeqzjlasw hltigkhjyl (ccgwvkfotp )	Positive	20 Jul 2023
				Sevelamer carbonate	nsxayojtld(ofznkmksxa) = aeqwjqbpbo hltigkhjyl (ccgwvkfotp )
NCT03988920 (NORMALIZE, CTgov)	Phase 4	Hyperphosphatemia \| Kidney Failure, Chronic	172	Sevelamer Carbonate+Tenapanor (Tenapanor w/Sevelamer)	udgdskcgye = wifpknpyas feyybqcjzc (vjtwqoqbic, qbvcdjnoze - bujqpuuzdw) View more	-	29 Mar 2023
				Sevelamer Carbonate+Tenapanor (Sevelamer w/Tenapanor)	udgdskcgye = ttxwzyumah feyybqcjzc (vjtwqoqbic, egxmdtmqxr - dzrtbnrqme) View more
ASN2022	Not Applicable	Chronic Kidney Diseases hyperphosphatemia	-	Sevelamer	skssqvtstb(zvaaevlgkz): HR = 0.84 (95% CI, 0.79 - 0.91) View more	Positive	05 Nov 2022
				Sevelamer (Cardiopulmonary Bypass (CPB))
ASN2021	Not Applicable	Chronic Kidney Diseases	-	Calcium acetate	ssjjxulosl(cizihardxx) = alghxgqoop kiqgmmlywv (wlcrfzooox )	-	27 Oct 2021
				Ferric citrate	ssjjxulosl(cizihardxx) = krfywetdqc kiqgmmlywv (wlcrfzooox )
MO797 (ERA2021)	Not Applicable	Chronic Kidney Diseases serum phosphate \| serum calcium ions \| FGF23 ... View more	-	Iron-based phosphate binders (sucroferric oxyhydroxide, ferric citrate)	tkuxhbydyb(xhvrzglyxb): SMD = 0.08 (95% CI, -0.02 to 0.17), P-Value = 0.08 View more	Negative	29 May 2021
				Non-calcium phosphate binders (sevelamer)
VIKI study (WCO_IOF_ESCEO2020)	Not Applicable	Hemodialysis complication vitamin K deficiency \| vertebral fractures \| vascular calcification	387	Sevelamer	bcfgqeqfdw(ercnxvzusn) = tyayyeoafv mmnqusgsvl (xfgnuqifkd ) View more	-	20 Aug 2020
				No Sevelamer	bcfgqeqfdw(ercnxvzusn) = tdffoiewsf mmnqusgsvl (xfgnuqifkd ) View more
NCT03001011 (RECOVER \| P0880, CTgov)	Phase 3	Hyperphosphatemia \| Chronic Kidney Diseases	202	Placebo (Placebo)	wroyiilyit(oxpwmrutly) = aymimkseet qbrfauqqjg (xpoqnnypyu, vzpzuwmrlv - isldxsonna) View more	-	28 Jul 2020
				Sevelamer Carbonate (GZ419831) (Renvela)	wroyiilyit(oxpwmrutly) = xdfuvaxipz qbrfauqqjg (xpoqnnypyu, iqkrnhfbce - ekoipksawg) View more
VIKI (ERA2020)	Not Applicable	25(OH)D \| ALP \| vitamers K1 ... View more	387	Sevelamer	fxplyrslaw(yxubfbavwa) = icxrcamkwl ytndspoxkp (ppilorbidv ) View more	Positive	06 Jun 2020
				No Sevelamer	fxplyrslaw(yxubfbavwa) = emhnojcvdm ytndspoxkp (ppilorbidv ) View more
VIKI Study (ASN2019)	Not Applicable	25(OH)D \| alkaline phosphatase (ALP) \| vitamers K1, MK4, MK5, MK6, MK7 ... View more	387	Sevelamer	qaxbslimya(zjblerrjhi) = wrlumabcdm ixvjsjyhuc (liqdlwevpg ) View more	Positive	05 Nov 2019
				No Sevelamer	qaxbslimya(zjblerrjhi) = ggdsfcsrxd ixvjsjyhuc (liqdlwevpg ) View more

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