Poxel Reports Consolidated Revenue for the First Quarter 2025 and Provides Corporate Update
LYON, France--(BUSINESS WIRE)--Regulatory News:
POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today reported its revenue for the quarter ended March 31, 2025 and provided corporate update.
Thomas Kuhn, Chief Executive Officer of Poxel, stated: 'TWYMEEG ® has further demonstrated its strong potential in FY 2024 1 with the commercial performance in Japan representing a 65% increase over FY 2023. This robust growth is expected to continue in FY 2025 and beyond, and should be further strengthened driven by a number of key recent milestones, including the recent regulatory approval in Japan allowing TWYMEEG ® to be prescribed to type 2 diabetic patients with moderate to severe renal impairment, a key patient population, particularly elderly individuals with renal impairment, who are faced with limited treatment options. In parallel of these achievements, our top priority remains to secure a path forward for the Company. We continue to be actively engaged in discussions with our creditors with the aim of reaching a structuring solution that would ensure the continuity of the Company's operations, and with potential partners to develop strategic opportunities to unlock the value of our pipeline of products.'
Commercial and Clinical Update
TWYMEEG ® (Imeglimin)
For the quarter ended March 2025, TWYMEEG ® gross sales in Japan totalled JPY 1.9 billion (EUR 12 million) 2. As a result, for Sumitomo Pharma's FY 2024 1, TWYMEEG ® gross sales reached JPY 7.6 billion (EUR 47.1 million) 2, in line with Sumitomo Pharma's most recent FY 2024 guidance (JPY 7.9 billion) and representing an increase by 65% over FY 2023.
For its FY 2025 5, Sumitomo Pharma forecasts gross sales for TWYMEEG ® of JPY 11.2 billion 4 (EUR 69.4 million) 2 which would represent a 47% increase over FY 2024 TWYMEEG ® gross sales. This forecast includes an incremental uptake among type 2 diabetic patients with renal impairment following the recent approval by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to revise TWYMEEG ® package insert for patients with renal impairment with eGFR (estimated glomerular filtration rate) less than 45 mL/min/1.73m 2.
Based on this FY 2025 forecast, TWYMEEG ® could reach JPY 10 billion net sales (EUR 62 million) 2 entitling Poxel to receive 12% royalties on all TWYMEEG ® net sales and a second sales-based payment of JPY 1 billion (EUR 6.3 million) 2. Following the recent royalty monetization agreement with OrbiMed, these proceeds will go exclusively towards the reimbursement of the bonds issuance. Beyond 2025, Poxel expects to receive escalating double-digit royalties as well as additional sales-based payments upon achievement of contractually based sales thresholds.
In August 2024, topline results from the post-marketing clinical study, TWINKLE (TW YMEEG ® in d i abetic patients with re n al impairment: A post-mar k eting l ong-t e rm study) conducted by Sumitomo Pharma in Japanese type 2 diabetic patients with renal impairment confirmed TWYMEEG ® 's safety and tolerability profile, which is consistent with prior clinical studies. Based on these results, Sumitomo Pharma led discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan leading to the revision of TWYMEEG ® package insert for patients with renal impairment with eGFR (estimated glomerular filtration rate) less than 45 mL/min/1.73m 2 on April 8, 2025. This approval has enabled Sumitomo Pharma to immediately start promoting the use of TWYMEEG ® in this population.
This regulatory milestone builds on the recently granted patent (n°7635474) by the Japanese Patent Office to Poxel 6 covering the use of Imeglimin in type 2 diabetic patients with moderate to severe renal impairment until 2039, strengthening TWYMEEG ® 's patent portfolio in Japan and protecting its use in this population. Poxel previously received the grant of this patent in China 7, the world's second largest type 2 diabetes market, further supporting ongoing discussions initiated by the Company to develop Imeglimin beyond Japan.
PXL065
On March 20, 2025, positive top-line results for PXL065 were obtained from a preclinical study conducted in a mouse model of hypertrophic cardiomyopathy (HCM), the most common genetic cardiac disorder. The preclinical study was financed through a grant by DZHK 8 and conducted at the TUM University Hospital German Heart Center under a research collaboration. After 10 weeks of treatment, a significant reduction in myocardial hypertrophy associated with a significant reduction in cardiac fibrosis was demonstrated, highlighting the potential of PXL065 in this pathology. These results further support the clinical development of PXL065 as a potential disease-modifying treatment for symptomatic and asymptomatic HCM and will be presented at a future scientific meeting.
First Quarter 2025 Consolidated Revenue
Poxel reported EUR 1,066 thousand 2 consolidated revenue for the quarter ended March 31, 2025, representing a 137% increase compared to the 2024 Q1 revenue.
Consolidated revenue for the first quarter of 2025 reflects JPY 172 million (EUR 1,066 thousand 2) of royalty revenue from Sumitomo Pharma, which represents 10% of TWYMEEG ® net sales in Japan. Based on the current forecast, Poxel expects to receive at least 12% royalties on TWYMEEG ® net sales in Japan through the Sumitomo Pharma fiscal year 2025 5. As part of the Merck Serono licensing agreement, Poxel will pay Merck Serono a fixed 8% royalty based on the net sales of Imeglimin, independent of the level of sales. According to the Royalty Monetization agreement with OrbiMed, the positive net Royalties will be fully dedicated to the repayment of the bonds.
Update on existing event of default under the IRIS and IPF Partners existing bond financing agreements and search of structuring financial solution to ensure the continuity of the Company
Since the announcement by the Company of the events of default under the IRIS and IPF Partners outstanding bond financing agreements triggered by the non-adoption of the financial delegations at the Combined General Meeting held on February 11, 2025, the Board of Directors and the Management of Poxel continue to actively negotiate with the Company's creditors, with the aim of reaching a structuring solution that would ensure the continuity of the Company's operations. As announced on April 16, 2025, Poxel's financial outlook remains highly constrained with a cash runway currently estimated through June 2025, depending on the outcome of current discussions with the Company's creditors.
In parallel, the Company is also progressing discussions with several potential partners for the development of its pipeline products.
As already announced on April 16, 2025, given the potential impact on the Company's financial statements of the negotiations with the Company's creditors and potential partners, Poxel has postponed the approval and publication of its 2024 Full-Year Results. A new date will be communicated once these negotiations are finalized.
About Poxel SA
Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R -pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG ® (Imeglimin), Poxel's first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.
For more information, please visit: www.poxelpharma.com
All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by or including words such as 'target,' 'believe,' 'expect,' 'aim,' 'intend,' 'may,' 'anticipate,' 'estimate,' 'plan,' 'project,' 'will,' 'can have,' 'likely,' 'should,' 'would,' 'could' and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release.
Glossary
You will find below a list of words and/or expressions that are used in this press release or in Poxel's communication, with the aim of bringing clarification and transparency:
Sumitomo Pharma fiscal year runs April to March. As an example, Fiscal Year 2024 is April 1, 2024, through March 31, 2025.
TWYMEEG ® royalties: As per the Sumitomo Pharma's agreement, Poxel is entitled to receive royalties from the sales of TWYMEEG ® (Imeglimin) in Japan
Sumitomo Pharma communicates gross sales of TWYMEEG ®, while TWYMEEG ® royalties are calculated on net sales.
Net sales represent the amount of gross sales to which are deducted potential rebates, allowances, and costs such as prepaid freight, postage, shipping, customs duties and insurance charges.
Poxel is entitled to receive escalating royalties of 8-18% on TWYMEEG ® net sales from Sumitomo Pharma.
Positive net royalties: as part of the Merck Serono licensing agreement, Poxel will pay Merck Serono a fixed 8% royalty based on the net sales of TWYMEEG ®, independent of the level of sales. All royalties that Poxel receives from TWYMEEG ® net sales above that 8% level are considered as positive net royalties. Net royalties will therefore be positive for Poxel when TWYMEEG ® net sales exceed JPY 5 billion in a fiscal year and royalties reach 10% and above.
Poxel refers to the Group Poxel, including its affiliates (Poxel Inc. and Poxel KK) as well as the 3 security trusts set up as part of the Royalty monetization and debt restructuring operations announced on September 30, 2024.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
Lineage Announces Pricing of $500 million of Senior Notes due 2030
NOVI, Mich., June 10, 2025--(BUSINESS WIRE)--Lineage, Inc. (NASDAQ: LINE) (the "Company"), today announced that Lineage OP, LP (the "Operating Partnership"), a direct subsidiary of the Company, priced an offering of $500 million aggregate principal amount of 5.250% Senior Notes due 2030 (the "Notes") at a price of 98.991% of the principal amount. The Notes will be senior unsecured obligations of the Operating Partnership and will be fully and unconditionally guaranteed by the Company, Lineage Logistics Holdings, LLC and each other subsidiary of the Company (other than the Operating Partnership and certain excluded subsidiaries) that guarantees or is otherwise obligated in respect of the Company's revolving credit and term loan agreement. Interest on the Notes will accrue at a rate of 5.250% per annum and be payable semi-annually on January 15 and July 15 of each year. The Notes will mature on July 15, 2030. Closing of the offering is expected to occur on June 17, 2025, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the Notes to repay amounts outstanding from time to time under its revolving credit facility and for other general corporate and working capital purposes. The Notes have not been and will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the Securities Act. The Notes will be offered only to "qualified institutional buyers" under Rule 144A of the Securities Act or, outside the United States, to persons other than "U.S. persons" in compliance with Regulation S under the Securities Act. This communication is not an offer to sell or a solicitation of an offer to buy securities of Linage, Inc. or its subsidiaries, nor shall it constitute an offer, solicitation or sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. There can be no assurances that the offering of the Notes will be completed as described herein or at all. Safe Harbor Statement This press release contains forward-looking statements which are based on current expectations, forecasts and assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially, including statements related to the timing and consummation of the offering of the Notes and the expected use of the net proceeds. Forward-looking statements can generally be identified by the use of words such as words "estimate," "anticipate," "expect," "believe," "intend," "may," "will," "could," "should," "would," "seek," "position," "support," "drive," "enable," "optimistic," "target," "opportunity," "approximately" or "plan," or the negative of these words and phrases or similar words or phrases that are predictions of or indicate future events or trends and that do not relate solely to historical matters are intended to identify forward-looking statements. You can also identify forward-looking statements by discussions of strategy, plans or intentions of management. The Company can provide no assurances that it will be able to complete the offering on the anticipated terms, or at all. For a further list and description of such risks and uncertainties, see the Company's reports and other filings with the U.S. Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2024. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. View source version on Contacts Investor Relations ContactEvan BarbosaVP, Investor Relationsir@ Media Contact Megan HendricksenVP, Global Marketing & Communicationspr@
Yahoo
an hour ago
- Yahoo
argenx Presents New Efgartigimod Data at EULAR 2025 Highlighting Positive Phase 2 Proof-of-Concept Results in Myositis and Sjogren's Disease
ALKIVIA data demonstrate significant improvement in muscle strength and physical function in myositis patients treated with efgartigimod RHO data show efgartigimod achieved sustained reduction in autoantibodies and improved functional outcomes in patients with Sjogren's disease; program granted U.S. FDA Fast Track designation argenx committed to new therapeutic areas in rheumatology with ongoing Phase 3 studies in myositis (ALKIVIA) and Sjogren's disease (UNITY) June 11, 2025, 12:01 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the presentation of positive results from Phase 2 studies evaluating VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) in Sjogren's disease (SjD) and idiopathic inflammatory myopathies (IIM or myositis) at the European Congress of Rheumatology, EULAR 2025, from June 11 – 14 in Barcelona, Spain. argenx also announced that the U.S. Food and Drug Administration (FDA) has granted efgartigimod Fast Track designation (FTD) for the treatment of primary Sjogren's disease. 'Our innovation model prioritizes strong biologic rationale and efficient clinical program design, which enables us to rapidly advance development in rheumatic diseases,' said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. 'The accumulating body of evidence about the role of IgG autoantibodies reinforces the therapeutic potential of efgartigimod as a new approach for treating several rheumatic diseases – aiming to go beyond symptom management by targeting the underlying disease. The data presented at EULAR highlight efgartigimod's potential as a precision therapy for patients living with myositis and Sjogren's disease, and we are hopeful this novel treatment will offer a new therapeutic option and lead to improved outcomes for patients.' ALKIVIA Data Show Efgartigimod Provides Functional Improvement in Patients with Myositis Consistent and statistically significant treatment effect: In the ongoing, seamless ALKIVIA Phase 2/3 study evaluating three myositis subtypes (IMNM, ASyS, DM), data from Phase 2 show that patients demonstrated significant improvement in muscle strength and physical function when treated with efgartigimod. The study's primary endpoint, mean Total Improvement Score (TIS) at 24 weeks, is a composite of six core measures of disease activity and muscle function. TIS improvement was observed in a majority of efgartigimod-treated patients across all six core measures, and the primary endpoint was met. Efgartigimod patients showed a significantly higher mean TIS of 50.45 compared to 35.65 in the placebo arm (2-sided P=0.0004). In addition, for patients treated with efgartigimod, 79% achieved a moderate improvement (TIS ≥40) and 34% achieved a major improvement (TIS ≥60), compared to 47% and 9.5% respectively of patients receiving placebo. Favorable Time to TIS and Safety Profile: Among the study's secondary endpoints, patients receiving efgartigimod improved significantly faster than patients receiving placebo, leading to a median time to minimal improvement (TIS ≥20) of 30 days and time to moderate improvement (TIS ≥40) of 16 weeks. Comparatively, patients in the placebo arm reached minimal improvement (TIS ≥20) in 72 days, while there was no majority of placebo patients reaching moderate improvement (TIS ≥40) at any point in the 24-week study. Efgartigimod was well-tolerated and the proportion of patients experiencing at least one treatment-emergent adverse event (TEAE) was similar in the efgartigimod and placebo arms. Evaluation of efgartigimod in myositis is ongoing in the Phase 3 portion of the ALKIVIA study. 'Myositis is a debilitating disease that can cause muscle weakness, affect multiple organs, and have a severe impact on patients' quality of life. Physicians struggle to treat it because current options are limited and have significant side effects,' said Hector Chinoy, Ph.D., ALKIVIA study investigator and Professor of Rheumatology and Neuromuscular Disease at The University of Manchester. 'Results from this study, the first of an FcRn inhibitor in myositis, demonstrate the potential of a transformative targeted treatment approach. Efgartigimod was well-tolerated and led to significant improvements compared to placebo, offering new hope for a treatment that targets autoantibodies as one of the potential key drivers of disease.' RHO Data Show Efgartigimod's Clinical Effect Across Endpoints in Sjogren's Disease Improved systemic disease activity and reduction in symptoms: In the Phase 2 proof-of-concept RHO study, efgartigimod showed significant improvement in systemic disease activity and patient symptoms. 45.5% of patients receiving efgartigimod achieved improved outcomes on the CRESS composite primary endpoint at Week 24 – including systemic disease activity, salivary and tear gland function – compared to 11.1% among patients treated with placebo. Improvements among patients treated with efgartigimod were achieved in 4 out of 5 CRESS measures. In addition, disease activity among patients treated with efgartigimod showed a median change in clinESSDAI total score of -7.0 versus -4.0 in the placebo arm. A key secondary endpoint is the cSTAR composite of five disease measures, which showed patients treated with efgartigimod achieved a 54.5% response versus 33.3% in the placebo arm. Potential for disease biology modulation: Biomarker response in RHO study also demonstrated rapid and sustained reduction of IgG with a ~60% reduction from Week 4 onwards. The efgartigimod group showed notable decreases in the disease-associated antibodies anti-Ro52 (-57% vs +13%) and Rheumatoid Factor (-26.6% vs -5.3%), as well as reduction in C1Q immune complexes (-4.5 vs -0.06 mc eq/mL) compared to placebo. Efgartigimod demonstrated a favorable safety profile among patients with Sjogren's disease. The observed safety and tolerability was consistent with other clinical trials, with no new safety signals observed. The Phase 3 UNITY trial is currently ongoing to assess efficacy and safety of efgartigimod in patients with moderate to severe Sjogren's disease. 'These data suggest that targeting FcRn and reducing IgGs has a meaningful impact on Sjogren's disease,' said Isabelle Peene M.D., Ph.D., study investigator, Department of Rheumatology, Ghent University Hospital. 'The clinical and biomarker findings add to our growing understanding of IgG autoantibodies in Sjogren's disease and could inform future treatment strategies for this complex, progressive and underserved condition.' More information on the data presented at the EULAR 2025 meeting can be found for presentations are as follows: Title Presenter Presentation Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants with Active Idiopathic Inflammatory Myopathy: Phase 2 Results from the ALKIVIA Study Hector Chinoy Oral Presentation #OP0002Session: Abstract PlenaryWednesday, June 1116:40-16:50 CEST Treatment of Sjögren's disease by blocking FcRn: clinical and translational data from Rho, a phase 2 randomized, placebo controlled, double-blind, proof-of-concept study with efgartigimod Isabelle Peene Oral Presentation #OP0041Session: Clinical AbstractWednesday, June 1116:30-16:40 CEST Efficacy and safety of efgartigimod PH20 subcutaneous by prefilled syringe in adults with Sjögren's disease: A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial with open-label extension (UNITY) Simon Bowman Poster #POS0844Poster View IIIThursday, June 1212:00-13:30 CEST Safety, tolerability, and efficacy of empasiprubart in adults with dermatomyositis (EMPACIFIC): A Phase 2, randomized, double-blind, placebo-controlled, multicenter study Tetyana Storie Poster #POS1049Poster View VIFriday, June 1312:00-13:30 CEST ALKIVIA Study DesignThe ALKIVIA study is a randomized, double-blind, placebo-controlled, multicenter, operationally seamless Phase 2/3 study of efgartigimod SC for the treatment of idiopathic inflammatory myopathies (IIM or myositis) across three subtypes, including immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM). The ALKIVIA study enrolled 240 patients in total and is being conducted in two phases, with an analysis of the Phase 2 portion of the clinical trial after the first 90 patients completed the study, followed by a Phase 3 portion if a signal is observed in the Phase 2 portion. The primary endpoint is the mean total improvement score (TIS) at the end of the treatment period (24 weeks in Phase 2 and 52 weeks in Phase 3) of all treated patients (IMNM, ASyS, DM) compared to placebo. Key secondary endpoints include response rates at the end of treatment, time to response, and duration of response in TIS, as well as change from baseline in individual TIS components. Other secondary endpoints include quality of life and other functional scores. About Idiopathic Inflammatory MyopathiesIdiopathic inflammatory myopathies (myositis) are a rare group of autoimmune diseases that can be muscle specific or affect multiple organs including the skin, joints, lungs, gastrointestinal tract and heart. Myositis can be very severe and disabling and have a material impact on quality of life. Initially, myositis was classified as either DM or polymyositis, but as the underlying pathophysiology of myositis has become better understood, including through the identification of characteristic autoantibodies, new polymyositis subtypes have emerged. Two of these subtypes are IMNM and ASyS. Proximal muscle weakness is a unifying feature of each subtype. IMNM is characterized by skeletal muscle weakness due to muscle cell necrosis. ASyS is characterized by muscle inflammation, inflammatory arthritis, interstitial lung disease, thickening and cracking of the hands ('mechanic's hands') and Raynaud's phenomenon. DM is characterized by muscle inflammation and degeneration and skin abnormalities, including heliotrope rash, Gottron's papules, erythematous, calcinosis and edema. RHO Study DesignThe Phase 2 RHO study was a randomized, double-blinded, placebo-controlled multicenter proof of concept study to evaluate the safety and efficacy of efgartigimod in adults with Sjogren's Disease. In order to enter the study, patients needed to test positive for anti-Ro autoantibodies and maintain residual salivary flow. Thirty four patients were randomized 2:1 to receive either efgartigimod or placebo for up to 24 weeks. Multiple endpoints and biomarkers were evaluated in the signal-finding study, including the primary endpoint of CRESS (Composite of Relevant Endpoints for Sjogren's Syndrome). Within CRESS there are five components spanning: systemic disease activity as measured by the ESSDAI (EULAR Sjogren's Syndrome Activity Index), patient reported outcomes as measured by the ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index), tear and salivary gland function and serology. To be a CRESS responder, patients needed to demonstrate a clinically meaningful benefit in at least 3 of the 5 composite items. Additional datapoints were gathered including the clinESSDAI, STAR (Sjogren's Tool for Assessing Response), biomarker data, and the change in lymphocytic infiltrate levels through parotid biopsies. About Sjogren's DiseaseSjogren's Disease (SjD) is a chronic, slowly progressive inflammatory systemic autoimmune disease characterized by immune-mediated destruction of exocrine glands. SjD can be severely debilitating and have a negative impact on patient quality of life, with common symptoms reported as dry eyes and mouth, fatigue, and joint point. In addition, a substantial subset of patients suffer from extraglandular systemic disease. While the presence of anti-Ro and anti-La IgG autoantibodies are considered a hallmark of disease, the underlying cause of SjD is believed to be multi-factorial, triggered by environmental factors, leading to autoimmunity and chronic inflammation. SjD predominantly impacts women with a 9:1 female:male incidence ratio. Given the heterogeneous nature of the disease, the treatment journey can be challenging with long delays and high rates of misdiagnosis. There are no FDA- approved treatments targeting the disease itself, leaving current treatments to focus primarily on individual symptom management. About EfgartigimodEfgartigimod (efgartigimod alfa and hyaluronidase-qvfc) is a human IgG1 antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor (FcRn) and blocking the IgG recycling process. Efgartigimod is the first-approved FcRn blocker globally and is marketed as VYVGART® and VYVGART® Hytrulo in the United States and China for the treatment of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP), and as VYVDURA (Japan) or VYVGART SC for gMG in other regions globally. Efgartigimod is currently being evaluated in more than 15 severe autoimmune diseases where pathogenic IgGs are believed to be mediators of disease. About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit and follow us on LinkedIn, Instagram, Facebook, and YouTube. For further information, please contact: Media: Colin McBeancmcbean@ Investors: Alexandra Royaroy@ Forward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, 'forward-looking statements.' These forward-looking statements can be identified by the use of forward-looking terminology, including the terms 'aim,' 'are,' 'believe,' 'can,' 'commit,' and 'will' and include statements argenx makes concerning its commitment to improving the lives of people suffering from severe autoimmune diseases and to new therapeutic areas in rheumatology; the discussion of its Phase 2 proof-of-concept results as well as the ongoing Phase 3 studies for efgartigimod in myositis and Sjogren's disease at EULAR 2025, including the planned agenda of such congress; its ability to rapidly advance development in rheumatic diseases; its goal to have efgartigimod not just manage symptoms but target the underlying disease and its potential as a precision therapy for myositis and Sjogren's patients; the potential for efgartigimod to be a transformative targeted treatment approach; and its hope that efgartigimod leads to improved outcomes and offer a new therapeutic options for such patients. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx's U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx's most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
an hour ago
- Business Wire
Lineage Announces Pricing of $500 million of Senior Notes due 2030
NOVI, Mich.--(BUSINESS WIRE)--Lineage, Inc. (NASDAQ: LINE) (the 'Company'), today announced that Lineage OP, LP (the 'Operating Partnership'), a direct subsidiary of the Company, priced an offering of $500 million aggregate principal amount of 5.250% Senior Notes due 2030 (the 'Notes') at a price of 98.991% of the principal amount. The Notes will be senior unsecured obligations of the Operating Partnership and will be fully and unconditionally guaranteed by the Company, Lineage Logistics Holdings, LLC and each other subsidiary of the Company (other than the Operating Partnership and certain excluded subsidiaries) that guarantees or is otherwise obligated in respect of the Company's revolving credit and term loan agreement. Interest on the Notes will accrue at a rate of 5.250% per annum and be payable semi-annually on January 15 and July 15 of each year. The Notes will mature on July 15, 2030. Closing of the offering is expected to occur on June 17, 2025, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the Notes to repay amounts outstanding from time to time under its revolving credit facility and for other general corporate and working capital purposes. The Notes have not been and will not be registered under the Securities Act of 1933, as amended (the 'Securities Act'), or any state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the Securities Act. The Notes will be offered only to 'qualified institutional buyers' under Rule 144A of the Securities Act or, outside the United States, to persons other than 'U.S. persons' in compliance with Regulation S under the Securities Act. This communication is not an offer to sell or a solicitation of an offer to buy securities of Linage, Inc. or its subsidiaries, nor shall it constitute an offer, solicitation or sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. There can be no assurances that the offering of the Notes will be completed as described herein or at all. Safe Harbor Statement This press release contains forward-looking statements which are based on current expectations, forecasts and assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially, including statements related to the timing and consummation of the offering of the Notes and the expected use of the net proceeds. Forward-looking statements can generally be identified by the use of words such as words 'estimate,' 'anticipate,' 'expect,' 'believe,' 'intend,' 'may,' 'will,' 'could,' 'should,' 'would,' 'seek,' 'position,' 'support,' 'drive,' 'enable,' 'optimistic,' 'target,' 'opportunity,' 'approximately' or 'plan,' or the negative of these words and phrases or similar words or phrases that are predictions of or indicate future events or trends and that do not relate solely to historical matters are intended to identify forward-looking statements. You can also identify forward-looking statements by discussions of strategy, plans or intentions of management. The Company can provide no assurances that it will be able to complete the offering on the anticipated terms, or at all. For a further list and description of such risks and uncertainties, see the Company's reports and other filings with the U.S. Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2024. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
