For smaller-volume, at-home administration, Halozyme highlighted Hypercon and Surf Bio, which management said can enable hyperconcentration of therapeutics up to approximately 500 mg/mL—potentially reducing injection volumes to less than 2 mL or into a 2 mL to 10 mL range that could fit either a small-volume autoinjector or Halozyme’s proprietary high-volume autoinjector.Torley also pointed to two areas of emerging interest for ENHANZE: potential applications with nucleic acids (including interest in lipid ...

Core Insights - KORU Medical Systems, Inc. (KRMD) has submitted a 510(k) premarket notification to the FDA for its FreedomEDGE infusion system to deliver PHESGO, a breast cancer treatment, subcutaneously instead of intravenously, marking a significant regulatory and strategic milestone for the company [2][5] Company Developments - The FDA clearance submission for FreedomEDGE aligns with KRMD's long-term growth strategy to transition oncology care from intravenous to subcutaneous drug delivery, potentially improving efficiency for infusion centers and easing the workload for nurses [3][7] - The successful clearance and commercialization of the FreedomEDGE system could expand KRMD's addressable market by establishing a subcutaneous delivery platform for oncology biologics, moving beyond its traditional immunology treatments [5][8] - The FreedomEDGE system aims to simplify the treatment process for infusion centers by addressing challenges such as complicated treatment steps and time constraints, thereby enhancing patient comfort and operational efficiency [9][10] Market Context - The subcutaneous drug delivery devices market is projected to be valued at $33.56 billion by 2025, with a CAGR of 7.62% through 2034, driven by the increasing prevalence of chronic diseases and the adoption of subcutaneous delivery devices [11]

Halozyme Therapeutics FY Conference Summary Company Overview - **Company**: Halozyme Therapeutics (NasdaqGS: HALO) - **Event**: FY Conference held on December 02, 2025 - **Key Speaker**: Dr. Helen Torley, CEO Core Business and Technologies - Halozyme is experiencing significant adoption of its technologies, particularly with argenx's VYVGART Hytrulo and the success of DARZALEX SubQ, where 96% of patients in the US utilize the SubQ version [2][4] - The recent acquisition of Elektrofi for its HyperCon technology aims to enhance home delivery of biologic therapies through autoinjectors, expanding Halozyme's portfolio to three leading technologies [2][5] Financial Performance - Halozyme has raised its revenue guidance to $1.3-$1.375 billion, driven by a 50% year-over-year growth in royalties, expected to reach $850-$880 million [4] - EBITDA is projected to grow nearly 50%, reaching between $880 million and $930 million [4] Product Portfolio and Future Growth - Key products driving revenue include DARZALEX, PHESGO, and VYVGART Hytrulo, with expectations for new products like SubQ OCREVUS, OPDIVO, TECENTRIQ, and RYBREVANT to contribute significantly in the coming years [6][7] - DARZALEX is projected to grow from $14-$15 billion this year to $18 billion by 2028, with over 90% of its use being SubQ with ENHANZE [8] - PHESGO is expected to grow to $3-$3.5 billion, while VYVGART Hytrulo is anticipated to reach $4 billion, with projections of $8 billion based on current indications [9] Regulatory Environment and IRA Impact - Concerns regarding the IRA price negotiation have been downplayed, with Halozyme confident that its products will not be significantly impacted due to their classification and the presence of biosimilars [11][14] - The One Big Beautiful Bill Act clarifies that products with multiple orphan indications will not be included in IRA negotiations, benefiting Halozyme's portfolio [12][13] Elektrofi Acquisition Insights - The acquisition of Elektrofi is seen as timely, as the company has secured major deals and is at a value inflection point with products expected to enter clinical trials soon [16][17] - HyperCon technology allows for higher concentration drug delivery, with IP protection extending to the mid-2040s, providing additional revenue opportunities [18][19] Litigation and Patent Portfolio - Halozyme is currently in litigation with Merck regarding its MDASE patent portfolio, which is separate from its ENHANZE portfolio, ensuring no risk to ENHANZE royalties [23][24] - The company is pursuing a permanent injunction and triple damages in the litigation, while remaining open to licensing agreements with Merck [24] Strategic Partnerships and Deal Structure - Halozyme is shifting towards non-exclusive deals for bispecific products, allowing for greater flexibility and collaboration with multiple partners [27][28] - The company aims to continue adding new products and royalty streams to sustain its growth trajectory [10][29] Conclusion - Halozyme is positioned for strong growth driven by its ENHANZE technology and the new HyperCon technology, with a robust pipeline of products and a favorable regulatory outlook [29][30]