Commercial revenue from specialty safety syringe systems is advancing
Company to launch its vial draw syringe systems in Q2 2023
Launch of high-value, next-generation polymer-based products expected in Q3 2023
NEW YORK, April 04, 2023 (GLOBE NEWSWIRE) — Sharps Technology, Inc. (the “Company”) (NASDAQ: “STSS” and “STSSW”), an innovative medical device and drug delivery Company offering patented, best-in-class syringe products, issues a shareholder update from Robert Hayes, the Company’s Chief Executive Officer.
Dear Fellow Shareholders:
Since the announcement of the manufacturing and research partnership with Nephron Pharmaceuticals in November 2022, we have made significant developments in the collaboration and will commence revenue from commercial operations for the first time with our specialty safety syringe systems for the healthcare market. As stated in the press release announcing the partnership, the agreement is focused on four key components: manufacturing; sales; business development; and manufacturing expansion. Since the fourth quarter of 2022, we announced the signing of a distribution agreement with Nephron, commenced manufacturing of Securegard from our wholly owned manufacturing facility in Hungary, introduced our portfolio of next generation specialty polymer-based syringe systems, and shipped the first containers of Securegard from Hungary. We are pleased with the developments that have occurred and look forward to the transition to revenue with Nephron and our broader market of customers.
The Company completed a capital raise in February that will be used to support the manufacturing of products through our partnership with Nephron. The raise strengthened our balance sheet and enables Sharps to advance the manufacturing of polymer-based prefilled syringe systems ahead of our planned commercial launch of that product line in the third quarter of 2023. Through the partnership with Nephron, Sharps has manufacturing capacity in South Carolina of up to 20 million units to support Sharps’ designs and another 25 million units to support Nephron products for prefillable syringe systems. The Company has plans to rapidly scale capacity, which could add an additional 100 million units annually by 2025.
For our vial draw product line, we recently announced the first shipment of 1 ml syringes to Nephron in January. Securegard will be the first product commercially available through Nephron’s sales portal of approximately 3,000 customers, which we anticipate will generate revenue beginning in second quarter 2023. Securegard is manufactured at our facility in Hungary, which currently has capacity of up to 50 million units, with potential annual capacity of 200 million units beginning in 2024, after expansion. We look forward to the launch of our first product to the market and will be introducing additional size configurations in the third quarter 2023.
The partnership with Nephron adds significant value to our Company and shareholders. The near-term launch of the Company’s next-generation polymer-based syringe products will provide additional growth opportunities as we expand the product line to a broad range of sizes, silicon-free systems that address contamination issues for the broader healthcare market, dual-chamber systems that improve drug shelf life while reducing unnecessary packaging, and customized solutions for the growing autoinjector segment. We anticipate high growth from our prefillable syringe products and have plans to expand manufacturing capacity in South Carolina to meet demand.
I would like to highlight the growing demand for prefillable polymer-based syringe solutions, which we feel will provide the future for Sharps Technology’s growth trajectory. Over the last 20 years, the pharmaceutical syringe operational model has shifted from the use of bulk syringes to prefillable syringes, increasing prefillables from 15% to 85%. The most common prefillable syringe systems are designed with pharmaceutical glass barrels that require the use of a complex series of production, washing, and preparation processes prior to sterilization. Sharps Technology’s solutions overcome these challenges, providing an ideal solution for the future demand of specialty polymer-based syringe drug filling solutions. By purchasing the prewashed and sterile systems in specialty nest and tub packaging, pharmaceutical operations can decrease their total cost of ownership. With new technologies in fill-finish equipment, syringe filling has become more accurate and faster making the customer more dependent on high quality innovative packaging solutions. This provides us confidence that we will see strong demand for our specialty prefillable syringe systems, which will be available in the highest growth segment of the drug packaging market.
With products developed and manufacturing in place in Hungary and South Carolina, I feel we are well positioned to deliver on our growth initiatives as we introduce products into the sales system. I would like to thank our shareholders for their support through our transition to revenue, and we look forward to providing updates as we move ahead.
Sincerely,
Robert Hayes, CEO
About Sharps Technology, Inc.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and ready to use processing. The company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US. For additional information, please visit www.sharpstechnology.com .
Forward-looking Statements
This press release contains “forward-looking statements” Forward-looking statements reflect our current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements include, but are not limited to, statements contained in this press release relating to our business strategy, our future operating results and liquidity, and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy, and other future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in government regulation; our ability to complete capital raising transactions; and other factors relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance, or achievements. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
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