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Santhera Secures Agreement with GEN for the Distribution of AGAMREE® (Vamorolone) in Türkiye
Globenewswire· 2025-08-13 05:00
Core Insights - Santhera Pharmaceuticals has signed an exclusive agreement with Gen İlaç ve Sağlık Ürünleri San. ve Tic. A.Ş. for the distribution and promotion of AGAMREE® (vamorolone) in Turkey for treating Duchenne muscular dystrophy (DMD) in patients aged four and older [1][2] - The supply and sales by GEN are expected to commence in the first half of 2026, starting with named patient sales followed by commercial sales [1] - Santhera will receive a small upfront payment and an ongoing percentage of net sales as per previous agreements [1] Company Overview - Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on developing innovative medicines for rare neuromuscular diseases with high unmet medical needs [7] - AGAMREE® (vamorolone) is a dissociative steroid with a novel mode of action, approved in multiple regions including the U.S., EU, UK, China, and Hong Kong for the treatment of DMD [7][9] - The company has out-licensed rights to AGAMREE for North America and certain Southeast Asian countries [9] Product Information - AGAMREE is designed to bind to the same receptor as glucocorticoids but modifies its downstream activity, potentially dissociating efficacy from steroid safety concerns [3] - In the pivotal VISION-DMD study, AGAMREE met the primary endpoint of Time to Stand (TTSTAND) velocity versus placebo with a p-value of 0.002 at 24 weeks, demonstrating a good safety and tolerability profile [4] - Unlike corticosteroids, AGAMREE shows no restriction of growth and has no negative effects on bone metabolism [5] Partner Company Overview - Gen İlaç ve Sağlık Ürünleri San. ve Tic. A.Ş. is Turkey's leading specialty pharmaceutical company, focusing on innovative therapies for neurological and neuromuscular disorders since 1998 [10] - GEN has a GMP-certified facility and invests in original drug development through dedicated R&D centers [10]
Icahn Enterprises(IEP) - 2025 Q2 - Earnings Call Presentation
2025-08-04 14:00
Financial Results - Q2 2025 net loss attributable to IEP was $165 million, compared to a net loss of $331 million for Q2 2024[6] - Q2 2025 Adjusted EBITDA loss attributable to IEP was $43 million, compared to an Adjusted EBITDA loss of $155 million for Q2 2024[6] - Indicative net asset value as of June 30, 2025, was approximately $3.3 billion, an increase of $252 million compared to March 31, 2025[6] - The company declares a second quarter distribution of $0.50 per depositary unit[6] Segment Performance - Energy segment: Adjusted EBITDA decreased by $127 million to a loss of $24 million for Q2 2025 compared to $103 million in Q2 2024[17, 20] - Automotive segment: Adjusted EBITDA decreased $27 million for Q2 2025 compared to Q2 2024, impacted by higher labor costs and operating expenses[23, 24] - Investment segment: Returns of negative 0.5% for Q2 2025[12, 14] - All Other Segments: Q2 2025 Adjusted EBITDA attributable to IEP was $17 million compared to $28 million for Q2 2024[31] Energy Segment Details - Refining margin for Q2 2025 was $2.21 per throughput barrel, compared to $10.94 during Q2 2024[17, 20] - Renewable margin for Q2 2025 was $0.38 per vegetable oil throughput gallon, compared to $0.43 in Q2 2024[17, 20] - Q2 2025 average realized gate prices for UAN increased by 18% to $317 per ton and ammonia increased by 14% to $593 per ton when compared to Q2 2024[17, 19]
Icahn Enterprises (IEP) Earnings Call Presentation
2025-06-25 06:40
Company Overview - As of March 31, 2025, Carl Icahn and his affiliates owned approximately 86% of IEP's outstanding depositary units[7,8] - As of May 15, 2025, IEP has a $200 annualized distribution, which is a 207% yield[7] - As of March 31, 2025, IEP has liquidity through its investment in the Investment Funds of approximately $25 billion[7] Financial Performance (LTM March 31, 2025) - Investment segment assets were $3850 million, with a net loss attributable to IEP of $333 million[7] - Energy segment assets were $4722 million, with net sales of $7393 million and a net loss attributable to IEP of $153 million[7] - Automotive segment assets were $1881 million, with net sales of $1470 million and a net loss attributable to IEP of $34 million[7] - Food Packaging segment assets were $434 million, with net sales of $397 million and a net loss attributable to IEP of $20 million[7] - Real Estate segment assets were $512 million, with net sales of $95 million and a net loss attributable to IEP of $6 million[7] - Home Fashion segment assets were $220 million, with net sales of $181 million and a net loss attributable to IEP of $9 million[7] - Pharma segment assets were $274 million, with net sales of $107 million and a net income attributable to IEP of $6 million[7]
Icahn Enterprises(IEP) - 2025 Q1 - Earnings Call Presentation
2025-05-07 12:33
Financial Performance - Icahn Enterprises L P reported a net loss attributable to IEP of $422 million for Q1 2025, compared to a net loss of $38 million for Q1 2024[6] - Adjusted EBITDA loss attributable to IEP was $287 million for Q1 2025, a decrease compared to an Adjusted EBITDA of $134 million for Q1 2024[6] - The Investment segment reported a net loss attributable to IEP of $224 million for Q1 2025, compared to a net loss of $23 million in Q1 2024[9, 12] - The Energy segment experienced a net loss attributable to IEP of $86 million in Q1 2025, compared to a net income of $49 million in Q1 2024[9] - The Automotive segment had a net loss of $27 million in Q1 2025, compared to a net loss of $9 million in Q1 2024[9] Segment Highlights - The Investment segment's Funds had a net long notional exposure of 20% as of March 31, 2025, with returns of negative 8 4% for Q1 2025[12] - The Energy segment's consolidated Adjusted EBITDA decreased by $264 million to a loss of $61 million for Q1 2025, compared to $203 million in Q1 2024[15, 18] - Automotive Services revenue decreased by $23 million primarily due to reduced pricing and a shift of consumer behavior toward lower priced offerings[23] - Aftermarket Parts revenue in the Automotive segment decreased by $11 million due to the exit of the Aftermarket Parts business, completed in Q1 2025[22, 23] - Food Packaging Q1 2025 Adjusted EBITDA attributable to IEP decreased by $6 million compared to prior year quarter primarily due to lower price and higher manufacturing inefficiencies[26, 30] Liquidity and Net Asset Value - As of March 31, 2025, the indicative net asset value was approximately $3 billion, a decrease of $336 million compared to December 31, 2024[6] - Total Holding Company liquid assets were $3 781 billion as of March 31, 2025, including $1 318 billion in cash and cash equivalents and $2 463 billion in Investment Funds[32]
PainReform Completes Strategic Acquisition of DeepSolar, Unlocking New Growth Opportunities in AI-Driven Solar Analytics
Globenewswire· 2025-03-05 16:00
Core Viewpoint - PainReform's acquisition of DeepSolar positions the company as a potential leader in the high-growth, high-margin AI solar energy management sector while maintaining its focus on pharmaceutical innovation [1][4]. Company Overview - PainReform is a clinical-stage specialty pharmaceutical company focused on reformulating established therapeutics, particularly in post-surgical pain relief [9]. - The company has successfully acquired 100% of DeepSolar, an AI-driven solar analytics platform, from BladeRanger Ltd [1][2]. Acquisition Details - The acquisition allows PainReform to enter the clean energy sector, leveraging DeepSolar's software to optimize solar farm efficiency and profitability [2]. - DeepSolar's AI analytics platform enhances energy production and reduces operational inefficiencies, integrating with SCADA systems for monitoring and predictive maintenance [3][6]. - The transaction involved PainReform issuing 178,769 ordinary shares and 223,792 pre-funded warrants to BladeRanger Ltd as part of the acquisition [7]. Market Potential - The solar energy market is projected to grow at an annual rate of 25.32%, generating over 1 terawatt (TW) of energy from 2021 to 2026 [3]. - The residential solar market reached a valuation of $94.2 billion in 2024 and is expected to grow at 8% annually through 2034 [3]. Strategic Goals - PainReform aims to broaden DeepSolar's customer base, targeting utility-scale solar operators, independent power producers, and residential solar users [2]. - The company plans to explore strategic partnerships with utility companies, solar technology providers, and smart grid operators to drive revenue growth [4][5]. - DeepSolar's SaaS model is expected to generate steady, high-margin revenue streams while reducing operational costs for customers by up to 30% [6]. Technological Differentiation - DeepSolar's AI capabilities provide a competitive advantage in the renewable energy market, positioning PainReform as a potential technology leader in solar asset optimization [6].