Sharps Technology, Inc. (STSS)
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May 13, 2026, 4:00 PM EDT - Market closed
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Q2 Virtual Investor Summit Event

Jun 10, 2025

Operator

Good day, and welcome to Q2 Investor Summit Virtual. We appreciate your participation in today's virtual event. Up next, we are pleased to introduce Sharps Technology. If you would like to ask a question during the webcast, you may click the Q&A icon button on the right side of your screen. Please type your question into the box and click Send to submit it. At this time, it is my pleasure to hand over the session to Robert Hayes, CEO at Sharps Technology, who will lead the presentation. Sir, the floor is yours.

Moderator

Hey, hey, sorry, Robert, you can now start your presentation.

Robert Hayes
CEO, Sharps Technology

Okay, thank you, Hywel. I'd like to thank the Investor Summit for the invitations for Sharps Technology to present at this conference. It's our first time presenting at the conference, and we're excited to be here and excited to share our story about what we've accomplished over the last several years. Sharps Technology is a specialized drug delivery company. We started the IPO in 2022 with a vision to develop this technology for healthcare and to specialize in kind of the advanced safety and low waste space for specialty syringes. We went public, as I mentioned, in 2022 with the plan to purchase our first facility in Europe and commercialize our products. Almost all of our products are approved by the FDA, the World Health Organization, and have CE mark capability.

We completed the IPO in April of 2022, raising about $16 million to allow us to get started, then acquiring the Safeguard Medical facility in Hungary. This is a small syringe operation that was privately held that had its own IP and advanced technology for the market. We were very excited to bring our technology in and also acquire the other technology that was there. This is a good pilot facility for our particular products, our particular company. We felt that was the right fit for us. One of the exciting agreements that we continue to work on is with a sales agreement, manufacturing agreement to bring prefilled syringes to the market in South Carolina. This is a large transaction. We are still working with that particular partner to finalize the potential opportunity.

This has taken some time due to some challenges with the potential deal, but we are hopeful that we can move forward with this later this year. The agreement that I really want to spend most of the time talking about is the $50 million revenue agreement for specialized SoloGard products for a U.S. contract filler of syringes here in Texas. The opportunity for us to begin manufacturing products this year and shipping product this year has been an exciting opportunity for us, really transformational for the business. We were able to acquire this agreement back in July of 2024, and then we worked to put together our manufacturing plan and our commercial plan to be able to support this customer.

The news was released a few weeks ago where we were able to ship our first products to that customer after the qualification phases were completed, and we continue to manufacture and prepare shipments to ship to this customer here in the United States. We used funding that we raised at the end of 2024 to be able to support this particular project as it required a large investment on our side in capital, including large molds, assembly equipment, and high-capability molding machines. Most of that equipment is on order, and will be arriving in the next several weeks, several months to allow us to begin qualification of that scale-up. We hope to have all of the new equipment operational for the facility here going into Q4.

We continue to use the pilot molds, the startup equipment that we had and that we acquired with the partnership with our customer, and we're excited to scale up here at the end of the year. As we continue to move forward, we were also successful in commercializing a few of our other products, the SecureGard and some specialty syringes that are used with pen systems. We feel that this is a critical point for Sharps with our operation in Hungary focused on the specialty syringe products that we have there. The two facilities that I talked about briefly are kind of summarized here. The facility on the right we own, there's no debt on the facility, there's no debt for the company. This is a small facility that can be scaled up.

We own property around the facility, and the facility has the potential to actually scale up to close to 100,000 sq ft. It contains all the necessary manufacturing capabilities to be able to support not only smart-safety syringe technology, but also prefilled syringe technology. The facility shown on the left is a rendering of the facility in South Carolina that we are trying to work to begin prefilled syringe operations hopefully later this year, early 2026. For those of you that aren't familiar with our story, this is a summary of the smart-safety syringe technology that we do have. SecureGard prevents our needle products that have safety technology either active or passive. We have ultra-low waste capabilities with the syringes, and they also have reuse prevention capability for the market.

The SoloGard products on the right are the products we'll be making for the large contract that I mentioned that we are producing against now for the U.S. filler here for the 10 mL syringe. The SoloGard product is really a high-end product to be used with medical pump systems for large hospitals, for drug delivery, for specialized therapies. Prefilled syringes is a newer technology to the market in certain ways. Historically, these products have been made with glass, type 1 borosilicate glass through the years in typically very small sizes. The glass process is very challenging for the market due to some of the limitations for how the glass is formed, the glass cartridges are put together. The prefillable syringe technology with copolymer materials has really been the solution to allow the market to take advantage of prefilled syringes.

Prefilled syringes are different than the specialty syringes that we talked about in the fact that these are actually sold to the drug manufacturers like Merck, like Pfizer, and other companies where they'll actually preload the drug therapy into the syringe at their facility and then sell the individual units to the healthcare provider for actual application for the patient. This provides a lot of advantages from the standpoint of efficiency, from the standpoint of how the drug is delivered and eliminates a lot of waste and complications in the healthcare system. The copolymer material works like glass, but it's much cleaner.

The process for how you produce the copolymer prefilled syringes is actually in a specialized clean room with injection molding capabilities, and you can make them in many different sizes, everything from 0.5 mL all the way up to 50 mL, where with glass syringes, you're typically limited to the smaller sizes and you're limited in the type of technology that you can bring to the market. For those of you that are familiar with the space, this is going to be our next area of focus. For Sharps, we feel like this is a high-growth area. I'll share some examples of why I think that, but products like the GLP-1 therapies and some of the other high-growth potential drug therapies are moving in this direction to support prefilled syringe products, pen system products, and other advanced technologies to help the inpatient.

A little bit of detail about our facility in Hungary. As I mentioned, we own this facility outright. We've been making improvements to the facility to be able to scale up for the large SoloGard contract that we're working against. We were very fortunate in the fact that this facility was actually a fully operational syringe business in its past life. It had injection molding capability, high-speed printing, assembly capabilities, clean room capabilities, and including sterilization. For people familiar with manufacturing, buying this facility gave us complete vertical integration for what we needed to do from molding components to printing to final assembly to sterilization. It allowed us to be very effective quickly in putting together small quantities for qualification for customer testing and now eventual commercialization of our products. We were very fortunate with this facility. The Hungarian government has been very supportive of us.

It's very friendly towards U.S. manufacturing, and there are other healthcare companies that make similar products that produce there. We feel like we're in a good place for our first facility for all the reasons I just mentioned. The facility in South Carolina is very exciting in the fact that it was designed to make large quantities of prefilled syringes. You see an image of one of our pilot products in the bottom right. These are the products that I mentioned are produced with specialized copolymer technology. We feel like this is the next generation of specialty syringe. These can be sold with or without needle. They're typically put together in a nest and tub configuration that are friendly for advanced filling technologies that our customers would use.

As I mentioned, there's different types of customers that would use these types of products, everything from branded drugs or advanced therapies all the way down to generic products. There's a wide range of application for these because they can be custom-made to solve problems in the market and also can be custom-made in different sizes and configurations to be able to put different therapies in the syringe platform. Again, this is a high-end product for this space. Typically, the selling price for these types of products is much, much higher, and the margins are significantly higher also. It's a nice space to be in from the standpoint of drug delivery. We feel that with the safety syringes and the prefilled syringes, we have found the right mix of products to be able to help Sharps grow.

A little bit more about the deal that was announced middle of last year that we have been continuing to update investors on includes the $50 million in sales for the SoloGard product for us with the opportunity to actually grow the agreement. This customer has been very friendly to Sharps. They've shared their strategic commercial plan for what they want to do and how they want to do it. They have been working with us to bring in our products, get them qualified as they want to take advantage of the low-waste technology and the capability for our products to work with their pump system customers. Supplying these 10 mL SoloGard syringes to our customer has started. As we announced, we received our first purchase order against the sales agreement. We'll continue to receive purchase orders as we are able to scale up and manufacture.

We expect to receive the next set of purchase orders here in the next few months. As we begin to produce at higher quantities, the purchase agreements to support the sales agreement will continue to come in. I know some investors on other conferences that we talked to wanted to understand how that was going to work. The bottom line is that we will be able to make and ship as much product as we can, and then the customer will take it. It is just a limitation of our ability to scale up quickly, get started, and to grow our business. We are working, as I mentioned, with some very reputable suppliers for the molds, the injection molding machines, and the assembly technology. These are leaders in the industry that we have worked with in our past, in previous companies.

They know what they're doing. They're going to be able to get us the equipment that will help us be very successful going forward. This will sell out all of the capacity that we have for SoloGard and then some. We will be in a position probably by the end of the year to be planning our first small expansion for the site to be able to put additional products into our operation in Hungary. Again, $50 million in sales, the opportunity to make and ship as many products as we can to support this. The purchase orders will continue to support our business. The opportunity to expand the facility at the end of the year could allow us to bring in another $25 million of business for that facility.

A little bit about the syringe market for our potential investors that might not know much about it. It is one of the highest-growth packaging spaces, specialty packaging spaces for the healthcare space. A lot of the pharmaceutical customers have been making large investments in syringe filling technology, whether it is glass or copolymer therapy syringes or other types of technology. People are wanting to move away from the glass vials that you traditionally see that are used with needle syringes and move towards the actual syringe market space that includes prefilled syringes. You can see in the bottom left, you have the disposable syringes. Those are typically your needle products, as I mentioned. Then you have the prefilled space. The prefilled space long-term will overtake a lot of the disposable space for what we consider to be targeted customers for us.

As I mentioned, the opportunity from a revenue perspective and profitability perspective is significantly different for this prefilled platform. For us, this is the right growth space. The disposable syringes with the safety technology, the prefilled syringes with some of the advanced capabilities that we mentioned about are the areas that we're moving in. This is very exciting for us because we have watched this trend for some time and are excited to take advantage of it. The disposable syringe space in particular includes standard syringes and safety syringes. As I mentioned, there are two different types of safety. You have the passive and you have the active. Depending on the healthcare provider, there are preferences in the market.

The ability to supply both is important, but we feel the safety syringe space is one of the faster-growing areas for the market to prevent the transmission of disease and to leverage low-waste capability and the reuse prevention that we feel like these are all the right things for syringes going forward. The prefillable syringe market, this is a space that I've worked in for many years. The glass and plastic technology are great solutions for our customers that need these types of products, but we feel the copolymer technology, the specialized plastic, is really the fastest-growing space and has all the advantages. Caps that sit in a nest and tub configuration. This is really a nice product to manufacture. It has advanced technologies.

It is a very specialized type of manufacturing, but for those that know how to put these together and the regulatory requirements around them, it's a nice business to have. For those of you that are not familiar with the types of customers that can use these types of prefillable syringes, my team put together just a small list of people that use them today in different ways and can use more of them. We have been talking with many of these customers behind the scenes about their interests, about sizes that they're looking for, and how we might be able to potentially help them. You can see it's a global demand. You can see everything from vaccines to Botox to biologics. It's a large space to be in, which is nice for us as we transition manufacturing capabilities to support this part of the market.

Some news that's relevant for investors that might not follow this space. Eli Lilly, I think most people know that company and what they do, along with a few of the other ones. They're making large investments, and there's many more than this out there in drug filling capability, not only for GLP-1 products, but also for other types of manufacturing capabilities to support the growth of their business. We feel that with the drug companies and the healthcare companies leading this investment growth plan, there's going to be a need for specialty packaging companies like Sharps, like a few others to make additional investments to be able to support this growth. There's an announcement by one of the players in the market.

SCHOTT is a German company where they, for the first time, are investing large amounts of money into a facility inside the U.S., more than $370 million into a facility in North Carolina. The fact that we identified this trend a few years ago, and then these drug companies are announcing their investments, and you see the specialized packaging companies coming right behind them, we feel like this is going to continue. It's going to continue in many ways. Healthcare companies do not just want one supplier. They do not just want one manufacturing plant. They want to have options. They want to have multiple sources of products. We feel like with some of our technology and our company being smaller but yet flexible from the standpoint of providing solutions to the space, that we will be able to take advantage of this growth. A little bit about our team.

A lot of people I've worked with in my past, Ben and Braden, that I've worked with. Zoltan has done a fantastic job in getting the facility in Hungary started up with our previous general manager, Filippo. We are very thankful to have those two guys working together. Drew Crescenzo, our CFO, has helped us manage a lot of the regulatory pathway requirements from the financial reporting. Good team on our side, many people below them to help us get things done. I felt it was important for investors to know that we have a lot of experience in this space. We have a lot of capability from the standpoint of what we do. I've been in the industry for more than 30 years. I've made all these products before in different ways in previous companies.

The opportunity for us to bring our products to the market is very exciting. Some highlights and summary information that I know people have asked about. We secured a $20 million financing in Q1, which basically allowed us to buy the equipment to support the SoloGard project and potential growth opportunities for the expansion at the facility. The $50 million agreement with SoloGard is significant because this is a huge growth opportunity for us, as I mentioned. This is really going to be some of the cornerstone business for us in Hungary. It has allowed us to build commercial momentum for us. Not only are we moving SoloGard, but we are also selling other products into the market. People are aware now that we are commercial. We have manufacturing capabilities. We are actually having new conversations with new customers about how we can potentially help them.

The big project for us is the prefilled syringe potential in South Carolina. Sharps is committed to prefilled syringes. Whether we do it in South Carolina or we expand Hungary, we're looking at both options. We've had a lot of strong interest in these products. We will be making announcements before the end of the year about how we're going to move forward with this strategy. We're looking at both options, and both of them have positive outcomes for the company. For us, I mean, people ask all the time the number of shares that we have, where we are with the warrants. We're in a better place with the warrants where what's left is either out of the money or the Series B warrants, which are the cashless warrants, have all been eliminated.

We are in a strong cash position of more than $11 million with no debt, and we're sitting at a market cap of $6 million. Hopefully this information will be helpful for investors. Again, it'll be in the presentation. It'll be on the website. Glad to take some questions.

Moderator

Thank you, Robert, for the presentation. For the audience, you can now start asking questions at the chat box.

It appears we don't have any questions coming in. Is that?

Yeah. Any more questions? Yeah. Maybe we'll wait another minute or two. Maybe they just.

Okay. We're happy to answer anything after the fact. I know that in the polls, we're happy to speak to folks on a one-on-one basis. Please reach out, or we'll connect and coordinate with Investor Summit to make that happen.

Robert Hayes
CEO, Sharps Technology

There's a question that just came in.

Asking about shipping product from Hungary. We've had no issues with shipping product from Hungary. The customer is located in Texas. Our target port of entry is Houston, and we've had no issues with what our shipping routes are going to be to date. Another question about what's your opinion on the competition. How do you think Sharps will do in the following years? That's the nice thing about our space, the drug delivery products, is that it's a very big space, as I shared with you. Our plan is to carve out really a specialty area within the market. Having been in this industry for more than 30 years, the advantages to being a solution provider is that a lot of healthcare companies have problems.

Many people do not know about them, or they do not read about them because a lot of them are not public. They target suppliers that can provide solutions in the market to help them run better, to help them deliver more effective products for their customers and eventually the end user. We feel like by targeting a niche space, a specialty space, and then leveraging the relationships we have with healthcare providers, that we will be able to be very effective and be able to perform the way that we need to perform.

Robert, there are a couple of others in the chat section. If you can see that from Chris Tuttle.

Yeah. The question is Hungary. Why did we pick Hungary? It was actually an opportunity that was presented to us before my time.

It was a privately held business there, and we were able to get it for very little money. Like I mentioned, it was a fully operational syringe facility that had all of the capabilities that we needed. Sharps leadership was actually doing product development work there early on. We felt like we had built a relationship with the people there and put us in a good place to be able to commercialize products. When you manufacture in this particular space, you need people that understand this market. Making syringes, because they're considered invasive devices, is a much different approach than making non-medical devices. You have to have expertise in that space. You need injection molding, sterilization, high-speed assembly. We had a lot of that there at the facility with the people that we got to know.

Hungary was a good starting point for us. Hungary, historically, has been friendly with the United States. We expect that to continue. We felt that was a good start. One of the questions is about the orders we have around the diversification. Are we in talks with other potential clients for SoloGard? We are. The way this market works, once they know you can produce certain types of technologies, people that are looking for solutions, as I mentioned, can reach out directly. We've actually had some direct and indirect contact with end users of our products, both for SecureGard and SoloGard. SoloGard's the product, the larger syringes without needle. What we are looking at is how we might configure those products for different types of customers. Some customers take them in bulk. Some customers take them within a nest.

Others take them in different configurations. To be able to target some of these additional customers, we're going to have to look at how we might have to set up some packaging technology to support them. Question about what distinguishes our company from the competition. As I mentioned, our products on the needle side have all of the capabilities built into a single device. We have the reuse prevention. We have the safety. We have the low waste. The low waste is a technology that became important to the market during the last pandemic. It will be needed for any future pandemics where the syringe that's typically used will waste about 100 microliters of product at the end of the syringe if it's not a low-waste technology. Our products typically are 20 microliters or less.

When you combine that savings over the number of injections that are given across the world, you can understand how much drug therapy can be saved for people that need it. If you do the math on that, it's a huge cost saving for our customer. When you combine that technology with reuse prevention to prevent the transmission of disease and you have the safety technology, our products, we feel, solve a lot of problems in aggregate. The prefilled syringes, like we talked about, it's a very specialized technology. If you are able to produce them in the copolymer material, you're able to bring solutions to the market that not everybody can produce. That combination of technologies and platforms, we feel, will help us carve out a nice business for Sharps.

Those are the ones I saw, Adam.

I do not know if there are any other ones out there.

No, yeah, I think that is it. I think we are running up against time here, but Hywel or—

Moderator

yeah, we are still good. We can extend up to maybe eight minutes more. If there are more questions, then we can extend more.

Okay. Yeah, we will leave it open for a couple of minutes here. Again, we are happy to connect offline and conduct one-on-ones, always available. Again, this presentation is on the website and would be happy to send it to you through Investor Summit if needed.

If there are no more questions, we can already do our outro.

Sure. Again, please connect us with anyone that has any interesting questions in meeting with Robert and I. All right. We will be happy to facilitate that, okay?

Yeah. Thank you.

Operator

That concludes Sharps Technology's presentation. You may now disconnect.

For details on upcoming presentations, please refer to the conference agenda. Thank you for your participation, and we look forward to welcoming you to the next session.

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