Full Press Release Details
Technology Issues Letter to Shareholders Covering the Announced Asset Purchase Agreement to Acquire InjectEZ Prefillable Syringe Manufacturing
Facility and the Associated $400 Million 10-Year Purchase Agreement with Nephron Pharmaceuticals
acquisition and purchase order enables Sharps to commercialize its innovative copolymer prefillable syringe systems to the healthcare
has a capitalization strategy through debt that has resulted in a signed term sheet with a leading middle-market lender for up to $75
YORK, September 28, 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.
Fellow Shareholders:
am pleased to update you on Sharps' recently signed Asset Purchase Agreement to acquire the InjectEZ facility , a specialty prefillable
syringe manufacturing facility, and the associated $400 Million 10-year purchase agreement with Nephron Pharmaceuticals. This is a transformative,
strategic set of events for Sharps and our shareholders, and I hope you share the enthusiasm I have for our future. I remain committed
to the vision I had upon signing the partnership with Nephron and will stay the course through the Company's transition to commercialization
in early 2024. The signed agreements with Nephron advance the manufacturing and research partnership that we announced in November 2022,
and reinforce our commitment to product innovation, advanced manufacturing, and commercialization. In this letter, I will provide key
highlights about the Company's vision, the proposed transaction, and the Company's ongoing operations.
Partnership with Nephron Continues:
relationship with Nephron has strengthened since the signing of the initial agreement last year. Through the successful completion of
the Asset Purchase Agreement and the 10-year purchase agreement, we will have a full partnership that will provide a strong baseline
of revenue for Sharps for many years, supported by the $400 Million commitment from Nephron for the period. With full control of the
InjectEZ facility through this transaction and the capacity from our wholly owned manufacturing facility in Hungary, Sharps will have
the ability to supply Nephron with their prefilled syringe needs and also commercialize our smart safety syringe products to the broader
healthcare syringe market. The agreement will leverage synergies from both companies and enable Sharps to commercially enter the prefilled
syringe landscape with strength and ahead of plan.
Revenue Stability and Growth:
key component of the InjectEZ acquisition is the 10-year purchase agreement with Nephron and their commitment for minimum orders of more
than $400 Million over the period. Nephron has committed to purchasing 10mL and 50mL prefillable copolymer syringes, with initial product
delivery scheduled for the first quarter of 2024 and revenue for the first twelve months totaling approximately $30 Million. Subsequent
shipments will continue until at least December of 2033 with minimum annual revenue of approximately $45 Million per year. In addition
to the purchase agreement, Sharps will benefit from supplying Nephron because of their valued brand in the healthcare industry and leadership
in areas such as 503B outsourcing, respiratory medicine, diagnostic kits, and specialty drug delivery solutions. As a company that is
transitioning from research and development to commercialization, this is a significant development that will have a meaningful impact
on Sharps' revenue and profitability. We anticipate Nephron's start-up volume to be approximately 60% of our initial planned
manufacturing capacity, which will provide Sharps with the ability to fully service Nephron's needs and to also sign purchase orders
for our products from other companies in the healthcare market. Looking ahead, our team has begun working on expansion at the InjectEZ
operation to provide for the additional planned capacity needed to service strategic customers in the branded and specialty Pharma space.
Through this transformation and growth, we are committed to producing innovative drug delivery solutions for the healthcare sector, including
smaller specialty configurations for biotech, ophthalmology, and cosmetic medicine.
Through Acquiring InjectEZ:
and operating the InjectEZ manufacturing facility will be a gamechanger for Sharps. Located on Nephron's campus in West Columbia,
South Carolina, the InjectEZ facility is a state-of-the-art manufacturing facility and one of the only fully dedicated specialized copolymer
pre-filled syringe manufacturing plants in North America. The operation has fully automated pre-fillable syringe system manufacturing
capabilities that include ISO cleanrooms for all key areas including injection molding, high speed automated assembly, and specialty
packaging that include the use of Husky molding machines and Hahn automation. Looking ahead, our team has begun planning for expansion
at InjectEZ to provide for additional capacity and expand our ability to service customers outside of Nephron. We have plans for expansion
that will double our capacity from the current 45 Million to 90 Million units per year and expand the range of products to include specialty
0.5mL and 1.0mL formats and custom configurations.
capitalization strategy for the InjectEZ transaction will use debt and preferred stock financing, while seeking to limit dilutive financings
to fund working capital needs. As stated in the press release on September 28, 2023, we have worked through a multi-month financing
process that has resulted in a signed term sheet with a leading middle-market lender for up to $75 Million in debt financing. Proceeds
from the financing will be used for the acquisition of InjectEZ, non-dilutive working capital, and facility enhancements. Through the
recent $5.6 Million raise, we are in a comfortable position with the working capital needed on hand as we work to close the debt financing.
We are working through this process with diligence and will provide updates as developments advance. We have also reached an agreement
with Nephron's Bill and Lou Kennedy to let Sharps begin critical work on the facility and start up product development activities
prior to closing the deal. This will allow for timely activities to be completed as soon as possible, per the agreed upon schedule. We
will use part of the $5.6 Million raise to complete several of these milestones.
Capacity for a Growing Prefillable Syringe Market:
capacity levels at InjectEZ will fully support orders from Nephron, as well as our current projections for additional business from the
open healthcare market for 2024 through 2026. We have design plans in place to double our capacity from 45 Million to 90 Million units
per year, which we are forecasting to be in place in late 2026. The additional capacity will be used to serve our core business focus
within the 503B and pharmaceutical segments of the healthcare industry, including specialty small volume pieces, infusion pumps, and
novel drug delivery systems. Market research is forecasting for significant growth within the prefillable syringe segment, with product
demand outstripping supply for the foreseeable future. The prefilled syringe market is a niche sub-industry within the healthcare sector
that is growing faster than GDP, specifically within the copolymer segment of the market that Sharps will serve. We are excited for the
opportunities for Sharps within this segment, as prefillable syringe capacity is at a premium due to the global lack of capacity, increasing
demand, and technical challenges in production that our team has a wealth of experience in.
Operations in Europe:
at our wholly owned facility in Hungary are moving forward and hitting milestones as planned. We continue to manufacture and export our
patented line of ultra-low waste, smart safety disposable syringe products for commercial use. In the first half of 2024, Sharps will
introduce the Sologard Locking Plus syringe, a specialty FDA and WHO approved syringe system that will be offered in 3mL to 10mL barrel
volumes. The team is also working to advance the facility to manufacture new product configurations and have identified opportunities
for specialized size and technology options for our segment of the market. The facility has sufficient capacity for our growing needs
and will be vital in supporting our efforts at the InjectEZ facility as we begin to execute on commercialization. While we remain committed
to developing and commercializing disposable smart safety syringe technologies for the healthcare market, the opportunity to accelerate
our prefillable syringe strategy, with support from the Hungary facility, will take priority in the near term to support our partnership
are at a pivotal time in our Company's history and the recent transactions position Sharps for exciting commercial growth. I would
like to thank Bill and Lou Kennedy at Nephron for their continued support and shared commitment to bringing our specialized products
to the market. We look forward to providing updates as we move ahead with our plans. I want to give my sincere thanks to our shareholders
for their continued support of Sharps Technology.
Technology is an innovative medical device and pharmaceutical packaging company offering patented, best-in-class smart-safety syringe
products to the healthcare industry. The Company's product lines focus on providing ultra-low waste capabilities, that incorporate
syringe technologies that use both passive and active safety features. Sharps also offers products that are designed with specialized
copolymer technology to support the prefillable syringe market segment. The Company has a manufacturing facility in Hungary and has partnered
with Nephron Pharmaceuticals to expand its manufacturing capacity in the U.S. For additional information, please visit www.sharpstechnology.com.
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,""poised" 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