UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 001-41355 Sharps Technology, Inc. (Exact name of registrant as specified in its charter) State or other jurisdiction of incorporation or organization (I.R.S. Employer Identification No.) ...

Company Overview and Milestones - Sharps Technology was founded in 2017 and completed its IPO in 2022, raising $16 million[3] - The company acquired SafeGard Medical in Hungary in July 2022, a facility producing specialty safety syringes[3] - In May 2024, Sharps Technology signed an Asset and Syringe Sales Agreement with Nephron and InjectEZ[4] - A $20 million underwritten public offering was closed in January 2025[5] Manufacturing and Product Line - The company has an operational manufacturing facility in Hungary (~40k Sq Ft) and a pending facility in Columbia, South Carolina (~100k Sq Ft)[10, 12] - The Hungary facility has a capacity of 45 million units, expandable to 200 million units[23] - The South Carolina facility is expected to have a capacity of 60 million units per year, expandable to 90 million units per year[28, 29] - Sharps Technology has a product line of patented smart safety syringe systems, including Securegard, Provensa, Sologard Locking +, and Sologard[6, 14] Sales and Financials - A multi-year agreement with a U S leader in IV flushing solutions is expected to generate over $50 million in revenue over five years, with first shipments in Q2 2025[4] - The company received a $400,000 purchase order in June 2025 and began shipments for SoloGard[34] - The agreement for SoloGard could involve +500 million units over five years[36] - The company has $11.9 million in cash and no debt[67] Market Overview - The global syringe market was valued at $22.5 billion in 2023, with a CAGR of approximately 9.2%[39, 40] - The disposable syringe market was valued at $13.1 billion in 2023, with a CAGR of approximately 6.1%[43, 44] - The prefillable syringe market was valued at $8.1 billion in 2023[39]

Core Insights - Sharps Technology, Inc. has initiated the second shipment of SoloGard syringes under a $50 million supply agreement with a U.S. healthcare partner, marking a significant step in its commercial operations [1][2][4] - The company is implementing advanced manufacturing upgrades, including new molding and automation systems, to enhance production capacity and efficiency in response to anticipated demand [2][4][7] - The ongoing phased manufacturing upgrade strategy includes a $400,000 purchase order as part of a five-year agreement to supply up to 500 million SoloGard syringes, indicating a transition into revenue-generating operations [3][4] Manufacturing and Operational Enhancements - The newly installed molding and automation systems are expected to improve energy efficiency by over 10 times compared to previous systems, thereby reducing costs and promoting sustainable production [7] - Facility upgrades are being made to cleanroom environments and control systems to enhance product quality and ensure regulatory compliance [7] - Integration of new ancillary systems aims to increase throughput and optimize molding and assembly workflows, supporting the company's long-term growth strategy [7] Product and Market Positioning - Sharps Technology focuses on innovative medical devices, particularly smart safety syringes that feature ultra-low waste design and advanced safety technologies [5] - The SoloGard syringes are FDA- and WHO-approved, highlighting the company's commitment to meeting high regulatory standards in the healthcare industry [3][5] - The company aims to position itself as an innovation-driven manufacturing partner within the healthcare sector, leveraging its strategic investments to fulfill major contracts and scale recurring revenue [4]

Summary of Sharps Technology (STSS) Conference Call Company Overview - **Company Name**: Sharps Technology - **Ticker Symbol**: STSS - **Industry**: Drug delivery and medical devices, specializing in smart safety syringes and prefillable syringes - **Founded**: 2017, IPO completed in 2022 [4][2] Key Points and Arguments Business Developments - **Sales Agreement**: Signed a $50 million agreement to supply SoloGuard products to a U.S. drug filler, with initial shipments starting this quarter [7][24] - **Funding**: Successfully raised $20 million to expand the European facility to support the sales agreement [8][51] - **Product Commercialization**: Successfully commercialized three products: SoloGuard, SecurGuard, and a syringe for auto injectors [8][9] Facilities - **European Facility**: - Located in Hungary, fully operational with no debt [10][11] - 40,000 to 45,000 square feet, expandable for future sales agreements [11] - **South Carolina Facility**: - Under negotiation for acquisition, 100,000 square feet, specialized for prefilled syringes [12][21] Product Lines - **Smart Safety Syringes**: Focus on low waste and reuse prevention technologies [16][29] - **Prefilled Syringes**: High-value products with significant revenue potential, transitioning from glass to copolymer materials for better manufacturing efficiency [17][23][29] Market Dynamics - **Growth Potential**: The syringe market, particularly disposable and prefilled syringes, is one of the fastest-growing segments in healthcare [27][30] - **Pricing**: Prefilled syringes priced between $1.50 to $6, compared to standard syringes priced at $0.10 to $0.50 [29][53] - **Demand for Injectable Filling Capacity**: Major pharmaceutical companies are investing heavily in filling technology, indicating strong market demand [35] Financial Health - **Debt-Free Status**: The company has no debt and approximately $12 million in cash [10][45] - **Market Capitalization**: Estimated around $6 million [45] Future Outlook - **Production Capacity**: Expected to ramp up to 120 million to 130 million units per year starting in year two of the sales agreement [25][50] - **Expansion Plans**: Potential to grow beyond the initial sales agreement with additional purchase orders anticipated [41][52] Additional Important Information - **Regulatory Approvals**: Products are FDA approved, CE marked, and WHO approved, highlighting the regulatory compliance necessary in the healthcare sector [6] - **Team Experience**: Leadership team has extensive experience in drug manufacturing and packaging, enhancing investor confidence [36][37] - **Market Trends**: Increasing demand for GLP-1 drugs and the transition to prefilled syringes and auto injectors are expected to drive future growth [52][53] This summary encapsulates the key points discussed during the Sharps Technology conference call, providing insights into the company's operations, market position, and future growth potential.

Summary of Sharps Technology Conference Call Company Overview - **Company**: Sharps Technology (STSS) - **Industry**: Specialized drug delivery systems, focusing on safety syringes and prefilled syringes [4][5] Key Points and Arguments - **IPO and Funding**: Sharps Technology went public in April 2022, raising approximately $16 million to acquire a facility in Hungary and commercialize its products [5] - **Acquisition of Safeguard Medical Facility**: The acquisition of a syringe operation in Hungary provided Sharps with its own intellectual property and advanced technology [5][6] - **Sales Agreements**: - A significant $50 million revenue agreement for specialized Sologuard products with a US contract filler in Texas was secured, marking a transformational opportunity for the business [7][20] - Ongoing negotiations for prefilled syringes in South Carolina, although facing some challenges [6][7] - **Manufacturing Plans**: - Plans to scale up manufacturing capabilities in Hungary and South Carolina, with new equipment expected to be operational by Q4 [8][10][22] - The facility in Hungary is fully operational and capable of scaling up to 100,000 square feet, supporting both smart safety syringe technology and prefilled syringe technology [9][10][15] - **Product Development**: - Focus on SecurGuard and Sologuard products, which include advanced safety features and low waste capabilities [11][19] - Prefilled syringes made from copolymer materials are positioned as a high-growth area, offering advantages over traditional glass syringes [12][13][27] - **Market Trends**: - The syringe market is experiencing significant growth, with a shift from glass vials to prefilled syringes, driven by pharmaceutical companies' investments [24][25] - The prefilled syringe market is expected to overtake disposable syringes in the long term [25] - **Competitive Advantage**: - Sharps Technology's products feature low waste technology, which minimizes drug loss during administration, and reuse prevention capabilities, addressing safety concerns [50][51] - The company aims to carve out a niche in the specialty syringe market by leveraging relationships with healthcare providers [42][43] Additional Important Information - **Financial Position**: The company reported a strong cash position of over $11 million with no debt, and a market cap of $6 million [37] - **Future Plans**: Sharps is committed to expanding its prefilled syringe capabilities, with potential announcements expected by the end of the year [36] - **Industry Context**: Competitors like Eli Lilly and Schott are making significant investments in drug filling capabilities, indicating a growing demand for specialized packaging solutions [29][30] This summary encapsulates the key insights from the Sharps Technology conference call, highlighting the company's strategic direction, market opportunities, and competitive positioning within the specialized drug delivery industry.

Core Viewpoint - Sharps Technology, Inc. is transitioning to revenue-generating operations with its first commercial deliveries of smart safety syringe products, marking a significant milestone for the company [2][4]. Company Overview - Sharps Technology is a medical device and pharmaceutical packaging company that specializes in patented smart safety syringe products designed for the healthcare industry [4]. - The company focuses on ultra-low waste capabilities and incorporates both passive and active safety features in its syringe technologies [4]. - Sharps has a manufacturing facility in Hungary that has undergone significant upgrades to support high-volume production [2][4]. Recent Developments - The company has commenced shipments under three customer orders linked to previously announced purchase agreements, representing its first commercial deliveries [2]. - CEO Robert Hayes will present at the Life Sciences Virtual Investor Forum on June 12, 2025, providing an opportunity for real-time investor engagement [1][6]. Event Details - The Life Sciences Virtual Investor Forum will be an interactive online event where investors can ask questions in real-time [3]. - An archived webcast will be available for those unable to attend the live event [3].

Company Overview - Sharps Technology, Inc. is an innovative medical device and pharmaceutical packaging company that offers patented smart safety syringe products to the healthcare industry [6] - The company focuses on ultra-low waste capabilities and incorporates both passive and active safety features in its syringe technologies [6] - Sharps has a manufacturing facility in Hungary that has undergone significant upgrades to support high-volume production [2][6] Recent Developments - Sharps has commenced shipments under three customer orders tied to previously announced purchase agreements, marking its first commercial deliveries and transition to revenue-generating operations [2] - The company will present at the Virtual Investor Summit on June 10, 2025, at 10:00 AM ET, providing an opportunity for investors to gain insights into its operations and future prospects [1][8] Investor Engagement - The Investor Summit is tailored for investors focused on small- and micro-cap stocks, offering insights from management teams of emerging companies [3][4] - Registration for the Investor Summit is available for free, allowing investors to participate and learn more about Sharps and other companies [5]

Sharps Technology, Inc. STSS stock is trading higher on Wednesday.As per data from Benzinga Pro, session volume stands at 31.74 million versus an average volume of 674.72k.What Happened: The medical device and pharmaceutical packaging company initiated shipments for previously announced purchase orders across three customer orders.These shipments mark the company’s first deliveries of its SecureGard and SoloGard product lines and its transition to generating commercial revenue.“These initial shipments mark ...

Core Insights - Sharps Technology, Inc. has initiated shipments of its SecureGard™ and SoloGard™ smart safety syringes, marking its transition to a commercial-stage, revenue-generating company [1][5] Group 1: Product Shipments and Agreements - The first commercial order of SoloGard was shipped under a $50 million supply agreement with a U.S.-based leader in IV flushing solutions, including customized 10mL SoloGard syringes [2] - The initial purchase order for SoloGard is valued at $400,000 and is part of a five-year contract to supply up to 500 million syringes [2] - A separate shipment of SecureGard smart safety syringes was delivered to a Hungarian vaccine provider under a $100,000 purchase order, reflecting growing global demand [3] - Additionally, 200,000 units of 1mL low dead space syringes were shipped to a Swiss provider for use in specialized injection pens, representing the first tranche of a 1-million-unit order [4] Group 2: Manufacturing and Operational Milestones - The manufacturing of SoloGard is supported by advanced molding and automation technologies, enabling Sharps to meet anticipated demand increases in the second half of 2025 [2] - Significant upgrades to the Hungary-based facility have been made to support high-volume, high-precision production, enhancing production capacity and quality [5] - The company is building inventory and expanding capacity to support current and future purchase commitments under long-term strategic agreements [5] Group 3: Company Vision and Future Outlook - The CEO of Sharps Technology emphasized that these initial shipments represent a key operational milestone and validate years of R&D and strategic planning [5] - The company aims to deepen relationships with partners and drive additional growth in the upcoming quarters [6]

Summary of Sharps Technology (STSS) Conference Call - May 22, 2025 Company Overview - **Company**: Sharps Technology (STSS) - **Industry**: Medical Devices, specifically focusing on syringe technology Key Points and Arguments 1. **Sales Agreement**: The company executed a $50,000,000 sales agreement with a large US filler for 10 ml syringes, signed in July 2024, which will utilize most of the capacity of their European facility [1][2] 2. **Expansion Potential**: The agreement has the potential to expand production by an additional 250 million units, supported by a financial raise with Aegis to enhance equipment and technology [2] 3. **Facility Details**: The European facility is debt-free and specializes in smart safety syringe technology, with plans for scalability and expansion to meet contract demands [2][3] 4. **US Manufacturing Facility**: The company is actively seeking a US manufacturing facility, particularly in South Carolina, to produce prefillable syringes using advanced copolymer technology, which is seen as a significant growth area in drug delivery [3][4] 5. **Product Overview**: Current products include SecurGuard and Solarguard syringes, which feature low waste technology and passive safety mechanisms [4][5] 6. **Market Growth**: The prefilled syringe market is rapidly growing, with significant investments from healthcare companies, indicating a strong opportunity for organic growth and partnerships [8][9] 7. **Regulatory Challenges**: The medical device industry has a lengthy lifecycle from concept to commercialization, requiring extensive regulatory approvals [14][15] 8. **Revenue Generation**: The company anticipates early revenue generation in Q2 2025 from initial shipments to the US customer, with a commitment for ongoing orders as production scales [7][28] 9. **Debt Status**: The company is currently debt-free after using part of a $20,000,000 financing to pay down previous loans [25] 10. **Future Projections**: Plans to be cash flow positive by next year, with strategic projects aimed at bringing prefillable syringes to market [35] Additional Important Information 1. **Reverse Stock Split**: A reverse stock split was executed to comply with Nasdaq requirements, which is expected to enhance long-term value for investors [21][31] 2. **Warrant Structure**: Most warrants have been eliminated, improving the company's financial position [33] 3. **Market Demand**: There is increasing demand for prefilled syringes, with copolymer technology offering advantages over traditional glass syringes, such as reduced breakage and improved manufacturing processes [40][42] 4. **Production Capabilities**: The Hungarian facility is positioned to support both current and future production demands, with potential for expansion and flexibility in product offerings [50][52] This summary encapsulates the key insights from the conference call, highlighting Sharps Technology's strategic initiatives, market opportunities, and operational capabilities within the medical device industry.