STSS
Sharps Technology INC
NASDAQ
10-K: Sharps Technology Inc. Reports Full Year 2023 Results, Outlines Strategic Growth Initiatives
Sentiment:
Annual Results
29 March 2024 3:29 PM
Sharps Technology, Inc., a medical device company focused on safety syringe technology, reported its full year 2023 results, highlighting strategic partnerships and ongoing efforts to commercialize its product lines.
Worse than expected
The company's net loss increased significantly from $4.6 million in 2022 to $9.8 million in 2023.
The company has not generated any revenue to date, indicating a lack of commercial success.
Delay expected
There continues to be delays in the commercialization of the Sharps Provensa product line.
Capital raise
The company intends to finance its future development and commercialization activities and its working capital needs largely from the sale of equity securities and/or with additional funding from other traditional financing sources.
The company completed a securities purchase agreement in February 2023 and two simultaneous offerings in September 2023 to raise capital.
Summary
- Sharps Technology, Inc. is a medical device company specializing in safety syringes, with a focus on commercializing its patented technologies.
- The company incurred net losses of $9,841,638 in 2023 and $4,639,662 in 2022, with an accumulated deficit of $25,149,004 as of December 31, 2023.
- Sharps has not yet generated any revenue from the sale of its products.
- The company is working to amend agreements with Nephron Pharmaceuticals Corporation following an asset purchase agreement in September 2023.
- A cooperative sales and distribution agreement was established with Roncadelle Operations s.r.l. in March 2024, granting exclusive distribution rights in various regions.
- A previous distribution agreement with Nephron Pharmaceuticals Corporation was terminated in March 2024.
- The company is building inventory to support the Roncadelle distribution agreement and anticipates receiving additional orders in 2024.
- Sharps' disposable syringe lines have less than 20 microliters of dead space, compared to competitors' syringes with up to 140 microliters.
- The company is developing prefillable syringe systems with a projected product supply beginning in early 2025.
- Sharps has four issued patents, two pending patent applications in the United States, and four PCT patent applications.
- The company has 57 full-time employees, with 50 based in Hungary.
Sentiment
Score: 4
Explanation: The document presents a mixed picture. While there are positive developments such as new partnerships and product development, the lack of revenue and significant losses raise concerns. The company's future success is highly dependent on its ability to commercialize its products and secure additional funding.
Highlights
- Sharps Technology reported a net loss of $9.8 million for 2023, compared to a $4.6 million loss in 2022.
- The company has not generated any revenue to date.
- A new sales and distribution agreement with Roncadelle Operations s.r.l. was established in March 2024, covering key global markets.
- The company terminated its distribution agreement with Nephron Pharmaceuticals Corporation in March 2024.
- Sharps' disposable syringes feature ultra-low waste technology with less than 20 microliters of dead space.
- The company is working towards the purchase of a manufacturing facility from Nephron in South Carolina.
- Sharps is developing prefillable syringe systems with a projected product supply beginning in early 2025.
- The company has four issued patents related to its syringe technology.
Positives
- The company has established a cooperative sales and distribution agreement with Roncadelle Operations s.r.l., expanding its market reach.
- Sharps' syringe technology offers ultra-low waste features, potentially providing a competitive advantage.
- The company is actively working to expand its product portfolio into prefillable syringes.
- Sharps has secured intellectual property protection with four issued patents.
Negatives
- The company has incurred significant net losses of $9.8 million in 2023 and $4.6 million in 2022.
- Sharps has not yet generated any revenue from product sales.
- The company terminated its distribution agreement with Nephron Pharmaceuticals Corporation.
- There are ongoing delays in the commercialization of the Sharps Provensa product line.
Risks
- The company has a limited operating history and may not succeed in commercializing its products.
- Sharps faces significant competition from established medical device companies.
- The company is vulnerable to new technologies that could render its products obsolete.
- Product liability claims could negatively impact the company's financial position.
- Changes in healthcare regulations could affect demand for the company's products.
- The company may not be able to raise capital as needed to develop its products or maintain operations.
- The company's stock price could be subject to extreme volatility.
- The company may face delisting from the Nasdaq Capital Market if it does not maintain listing requirements.
Future Outlook
The company intends to finance its future development and commercialization activities and its working capital needs largely from the sale of equity securities and/or with additional funding from other traditional financing sources. Sharps is working towards the purchase of a manufacturing facility from Nephron in South Carolina and anticipates product supply of prefillable syringes beginning in early 2025.
Management Comments
- Management continues to monitor the situation but has not experienced a significant disruption to its product development efforts.
- Management calculates the effective interest rate (EIR) to consider the potential repayment at redemption date by reference to the face value amount after taking into account the stated 8 % interest rate.
Industry Context
The medical device industry is highly competitive, with numerous companies offering safety syringes. Sharps is attempting to differentiate itself through its ultra-low waste technology and focus on both passive and active safety features. The company's expansion into prefillable syringes aligns with a growing market trend for ready-to-use drug delivery systems.
Comparison to Industry Standards
- Sharps' disposable syringe lines have less than 20 microliters of dead space, which is significantly lower than the 70 microliters Low Dead Space designation and the up to 140 microliters dead space found in competitors' syringes.
- Competitors in the safety syringe market include Retractable Technologies, Inc., Becton Dickinson & Company, Medtronic Minimally Invasive Therapies, Terumo Medical Corp., Smiths Medical, and B Braun, all of which have greater financial resources and established sales networks.
- The company's focus on both passive and active safety features aligns with World Health Organization requirements for syringe distribution programs.
Stakeholder Impact
- Shareholders are impacted by the company's net losses and the potential for stock price volatility.
- Employees are affected by the company's financial performance and future growth prospects.
- Customers and suppliers are impacted by the company's ability to commercialize its products and fulfill orders.
- Creditors are impacted by the company's financial stability and ability to repay debts.
Next Steps
- The company will continue to work with Nephron towards the purchase of the Nephron facility.
- Sharps will focus on building inventory to support the sales and distribution agreement with Roncadelle.
- The company will continue discussions with healthcare companies and distributors for sales of its products.
- Sharps plans to advance its new innovative products in connection with recent collaboration arrangements.
Related Party Transactions
- As of December 31, 2023 and 2022, accounts payable and accrued liabilities include $32,974 and $105,667, respectively, payable to officers, and directors of the Company.
Key Dates
- 2017-12-16: Sharps Technology, Inc. was initially incorporated in Wyoming.
- 2020-06-01: Sharps entered into an asset/share purchase agreement with Safegard Medical Kft.
- 2022-03-22: Sharps reincorporated as a Nevada corporation.
- 2022-04-13: Sharps' initial public offering (IPO) was declared effective.
- 2022-04-14: Sharps' common stock and warrants began trading on the Nasdaq Capital Market.
- 2022-07-06: Sharps closed the acquisition of the Safegard manufacturing facility in Hungary.
- 2022-09-22: Sharps entered into an agreement with Nephron Pharmaceuticals Corporation.
- 2023-02-03: Sharps completed a securities purchase agreement with institutional investors.
- 2023-09-22: Sharps entered into an asset purchase agreement with Nephron and InjectEZ.
- 2023-09-29: Sharps completed two simultaneous offerings, a Shelf Offering and a Private Placement.
- 2024-03-04: Sharps entered into a cooperative sales and distribution agreement with Roncadelle Operations s.r.l.
- 2024-03-08: Sharps terminated its distribution agreement with Nephron Pharmaceuticals Corporation.
Keywords
safety syringes, medical devices, prefillable syringes, ultra-low waste, distribution agreement, manufacturing facility, intellectual property, healthcare, pharmaceuticals, product commercialization
STSS
Sharps Technology INC
NASDAQ
Sector: TBD
Filings with Classifications
Delay expected
18 April 2025 5:25 PM
Current Report
- The company delayed the adoption of the Clawback Policy.
Worse than expected
18 April 2025 5:25 PM
Current Report
- The company failed to adopt the Clawback Policy in a timely manner, which is worse than expected for a Nasdaq-listed company.
Worse than expected
4 April 2025 5:00 PM
8-K Filing
- The company failed to meet the minimum stockholders' equity requirement for continued listing on the NASDAQ.
Worse than expected
2 April 2025 4:05 PM
Current Report
- The reverse stock split proposal failed to pass, which may limit the company's ability to meet Nasdaq listing requirements or improve its stock price.
Capital raise
2 April 2025 4:05 PM
Current Report
- The company consummated an offering and sale of securities on January 29, 2025.
- Stockholders voted to authorize the issuance of warrants and shares of common stock underlying the warrants in connection with this offering.
Better than expected
1 April 2025 5:24 PM
SEC Form 4 Filing
- The CEO increasing his stake in the company is a positive signal.
Capital raise
27 March 2025 5:30 PM
Annual Results
- The company completed a $20 million offering in January 2025.
- The company entered into subscription agreements with certain institutional investors in December 2024.
- The company entered into a securities purchase agreement and Senior Secured Note for an aggregate principal amount of $4.375 million in September 2024.
- The company completed two simultaneous offerings in September 2023.
- The company completed a securities purchase agreement with institutional investors in February 2023.
Delay expected
27 March 2025 5:30 PM
Annual Results
- The Company has delayed the commercialization of the Sharps Provensa product line.
- The products specialized technology requires further design and assembly optimization, which requires further capital investment and not currently budgeted.
Worse than expected
27 March 2025 5:30 PM
Annual Results
- The company has not generated any revenue to date.
- The company reported a net loss of $9.3 million for the year ended December 31, 2024.
- The company forfeited a $1 million escrow deposit related to a terminated asset acquisition agreement.
Worse than expected
20 March 2025 8:38 AM
8-K Filing / Press Release
- The company is at risk of being delisted from the Nasdaq stock exchange.
Worse than expected
14 March 2025 4:17 PM
8-K Filing
- The company received a delisting notice from Nasdaq due to its failure to maintain a minimum bid price of $1.00 per share.
Capital raise
11 February 2025 4:05 PM
Proxy Statement
- The company consummated a public offering on January 29, 2025, issuing units consisting of common stock, Series A Warrants, and Series B Warrants.
- The company also issued pre-funded units consisting of pre-funded warrants, Series A Warrants, and Series B Warrants.
- The company received net proceeds of approximately $18.2 million from the offering.
- The company intends to use the net proceeds from the Offering for working capital and other general corporate purposes and to repay the principal amount of $4,375,000 in outstanding senior notes of the Company.
Capital raise
30 January 2025 4:30 PM
Capital Markets Transaction Announcement
- Sharps Technology completed a public offering of common stock and warrants, raising approximately $20 million in gross proceeds.
- The offering included 14,285,714 common units or pre-funded units, each consisting of common stock or a pre-funded warrant, a Series A warrant, and a Series B warrant.
- Aegis Capital Corp. exercised its over-allotment option with respect to 2,142,857 Series A Warrants and 2,142,857 Series B Warrants.
Capital raise
28 January 2025 6:08 AM
Securities Registration Amendment
- The company is seeking to raise additional capital by offering units consisting of common stock and warrants.
- The maximum aggregate offering price of the units together with pre-funded units is $20,000,000.
- The total offering amount is $80,500,000 including common stock underlying the warrants.
Capital raise
27 January 2025 4:35 PM
S-1/A Filing
- The document details the terms of Series A and Series B warrants, which are often issued in connection with a capital raise.
- The warrants provide the holders with the right to purchase common stock at a specified exercise price, potentially bringing additional capital to the company upon exercise.
- The filing fee calculation table indicates a proposed maximum offering price of $72,450,000 for the securities being registered, suggesting a significant capital raise.
Capital raise
27 January 2025 12:28 PM
Warrant Agreement
- The warrants represent a potential future capital raise for the company as holders exercise their rights to purchase common stock.
- The exercise of the warrants will result in the issuance of new shares, which will provide the company with additional capital.
Capital raise
22 January 2025 4:06 PM
S-1/A Filing
- Sharps Technology is offering up to 8,108,108 units, each consisting of one share of common stock, one Series A warrant, and one Series B warrant.
- The company is also offering pre-funded units as an alternative for purchasers who would exceed ownership limits, with each pre-funded unit containing a pre-funded warrant, a Series A warrant, and a Series B warrant.
- The company intends to use the net proceeds for general corporate purposes, including working capital and investments, and to repay $4,174,658 in outstanding senior notes.
Delay expected
10 January 2025 5:21 PM
Prospectus
- There continue to be delays in the commercialization of the Sharps Provensa product line.
Capital raise
10 January 2025 5:21 PM
Prospectus
- The document details a proposed public offering of up to 6,726,457 units, each including common stock and warrants, or pre-funded units as an alternative.
- The company intends to use the net proceeds from this offering for working capital and other general corporate purposes and to repay outstanding debt, including $4,174,658 in outstanding senior notes.
Worse than expected
10 January 2025 5:21 PM
Prospectus
- The company has a history of losses and has not generated significant revenue from syringe sales to date, indicating worse than expected financial performance.
Capital raise
6 December 2024 9:22 AM
Capital Raise Announcement
- Sharps Technology is raising capital through the sale of 248,430 shares of common stock.
- The shares are priced at $1.95 each.
- The company expects to receive gross proceeds of $484,438 before fees and commissions.
Capital raise
5 December 2024 10:57 AM
Shareholder Letter
- The company is working with both government and private investment sources in Hungary to expand the current manufacturing footprint.
- The company mentions the need to raise capital to fund continuing operations as a risk.
Delay expected
5 December 2024 10:57 AM
Shareholder Letter
- The acquisition of the InjectEZ facility has been delayed due to business developments with the selling partner.
Better than expected
5 December 2024 10:57 AM
Shareholder Letter
- The company has secured significant sales agreements that will fully utilize current manufacturing capacity and drive substantial revenue growth.
- The company has regained compliance with NASDAQ listing rules, removing a potential risk.
Capital raise
5 December 2024 8:30 AM
Sales Agreement Announcement
- The company mentions the need to raise capital to fund continuing operations.
- The company is collaborating with both government and private investment sources in Hungary to expand the current manufacturing footprint.
Better than expected
5 December 2024 8:30 AM
Sales Agreement Announcement
- The company has secured significant sales agreements and sold out its existing inventory, indicating better than expected demand for its products.
Delay expected
14 November 2024 3:15 PM
Quarterly Report
- There continue to be delays in the commercialization of the Sharps Provensa product line.
- The products specialized technology requires further design and assembly optimization as identified in our previous commercialization efforts.
Capital raise
14 November 2024 3:15 PM
Quarterly Report
- The company intends to finance its commercialization activities and its working capital needs largely from the sale of equity securities and/or with additional funding from other traditional financing sources.
- The company completed a debt financing agreement for $4.375 million.
- The company issued 190,773 shares of common stock in a Reg A offering.
- The company issued 260,799 inducement warrants in connection with a warrant inducement program.
Worse than expected
14 November 2024 3:15 PM
Quarterly Report
- The company reported zero revenue for the quarter, which is worse than expected for a company that has been operating for several years.
- The company's working capital is insufficient to fund operations for the next 12 months, indicating a worsening financial situation.
- The company is facing multiple legal challenges, which adds to the negative outlook.
Worse than expected
15 October 2024 9:19 AM
Corporate Action Announcement
- The reverse stock split is a result of the company's share price falling below the Nasdaq minimum bid price requirement, indicating a negative performance.
Capital raise
30 September 2024 8:21 AM
Proxy Statement
- The company expects to continue to be able to raise capital to grow the Company following the reverse stock split.
- The company states that raising capital will likely be more challenging without shareholder approval of the reverse stock split.
Worse than expected
30 September 2024 8:21 AM
Proxy Statement
- The company needs to implement a reverse stock split to avoid being delisted from the NASDAQ, indicating that the share price is below the minimum bid price requirement.
Capital raise
30 September 2024 8:19 AM
Shareholder Communication
- The company states that the reverse stock split will allow them to have more access to capital to pursue their management teams growth strategies.
- The company expects to continue to be able to raise capital to grow the company following the reverse stock split.
Delay expected
30 September 2024 8:19 AM
Shareholder Communication
- The company had previously approved a 1-for-8 reverse stock split in July, but it was not implemented.
Worse than expected
30 September 2024 8:19 AM
Shareholder Communication
- The company is facing potential delisting from NASDAQ due to its stock price falling below the minimum bid price requirement, indicating worse than expected performance.
Capital raise
23 September 2024 8:13 AM
Bridge Financing Announcement
- The company has entered into a secured bridge loan financing of approximately $3.5 million.
- The financing includes the sale of secured notes and either common stock or pre-funded warrants.
- The company has agreed to file one or more registration statements with the SEC covering the resale of the Common Stock and the Shares issuable upon exercise of the pre-funded warrants.
Worse than expected
4 September 2024 6:12 PM
Proxy Statement
- The company needs to implement a reverse stock split to avoid being delisted from the Nasdaq, indicating that the company's stock price is below the minimum bid price requirement.
Capital raise
14 August 2024 4:41 PM
Quarterly Report
- The company intends to finance its commercialization activities and its working capital needs largely from the sale of equity securities and/or with additional funding from other traditional financing sources.
- The company completed a Reg A offering and warrant inducement program in the second quarter of 2024, raising approximately $3.5 million in gross proceeds.
- The company's stockholders approved an increase in authorized shares of common stock from 100,000,000 shares to 500,000,000 shares.
- The company's stockholders approved a proposal to authorize the Board of Directors to effect a reverse stock split of shares of the Company's common stock, at a ratio of up to 1-for-8.
Worse than expected
14 August 2024 4:41 PM
Quarterly Report
- The company's working capital is insufficient to fund operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern.
- The company has not generated significant revenue from syringe sales to date.
- The company's stock is facing potential delisting from the Nasdaq Capital Market due to non-compliance with the minimum bid price rule.
Delay expected
14 August 2024 4:41 PM
Quarterly Report
- There continues to be delays in the commercialization of the Sharps Provensa product line.
Capital raise
30 July 2024 4:05 PM
Corporate Action
- The increase in authorized shares suggests a potential future capital raise through the issuance of new shares.
- The company now has the capacity to issue up to 400 million additional shares of common stock.
Better than expected
25 July 2024 8:30 AM
Supply Agreement Announcement
- The agreement is expected to generate over $50 million in revenue, which is a significant positive development for the company.
- The agreement sells out the current manufacturing capacity of the EU facility, indicating strong demand for the company's products.
Capital raise
18 July 2024 5:10 PM
Special Meeting Results
- The company has been authorized to issue securities in one or more non-public offerings.
- These offerings can be at a discount of up to 20% below the market price of the common stock.
Worse than expected
15 July 2024 5:20 PM
Current Report
- The company received a delisting notice from Nasdaq, indicating a failure to maintain the minimum stock price requirement.
Capital raise
15 July 2024 5:20 PM
Current Report
- The company's stockholders approved a proposal for the issuance of securities in one or more non-public offerings.
- The maximum discount at which the securities will be offered will be equivalent to a discount not to exceed 20% below the market price of the common stock.
Capital raise
9 July 2024 9:13 AM
Proxy Statement
- The company is seeking to increase the authorized number of shares of common stock, if required for future equity transactions.
- The company is seeking approval to issue securities in non-public offerings where the maximum discount will not exceed 20% below the market price of the company's common stock.
Capital raise
9 July 2024 9:11 AM
Shareholder Communication
- The company is seeking authorization to increase the number of authorized shares of common stock.
- The company is seeking authorization to issue securities in non-public offerings with a maximum discount of 20% below the market price.
Capital raise
3 July 2024 11:16 AM
Proxy Statement
- The company is seeking approval to increase the authorized number of shares of common stock, which may be required for future equity transactions.
- The company is also seeking approval to issue securities in non-public offerings where the maximum discount will be equivalent to a discount not to exceed 20% below the market price of the company's common stock.
Capital raise
3 July 2024 11:14 AM
Special Meeting Announcement
- The company is seeking approval to increase the authorized number of shares of common stock, which may be used for future equity transactions.
- The company is also seeking the ability to issue securities in non-public offerings, with a maximum discount of 20% below the market price of the company's common stock.
Capital raise
25 June 2024 6:18 PM
Proxy Statement
- The company is seeking approval to issue securities in one or more non-public offerings.
- The maximum discount at which securities will be offered will be equivalent to a discount of 20% below the market price of our common stock.
- The company may seek to raise additional capital to implement our business strategy and enhance our overall capitalization.
Capital raise
17 June 2024 9:07 AM
Capital Raise Announcement
- The company raised $850,820.00 through the sale of 2,239,000 common shares at $0.38 per share.
- The company also received $330,000.00 from the exercise of 1,000,000 warrants.
- The company issued 1,000,000 new warrants exercisable at $0.45 per share.
Capital raise
4 June 2024 9:19 AM
Capital Raise Announcement
- The company raised $744,040 through the sale of 1,958,000 shares of common stock at $0.38 per share.
- The company received $1,465,715 from the exercise of 4,441,715 warrants.
- The company issued 4,441,715 new warrants exercisable at $0.45 per share.
Capital raise
3 June 2024 6:07 AM
Warrant Issuance Announcement
- The company is issuing new warrants to raise capital.
- The company expects to receive approximately $4,371,524 in gross proceeds if all new warrants are exercised.
- The funds will be used for capital expenditures, working capital, and general corporate purposes.
Better than expected
31 May 2024 8:35 AM
Shareholder Update
- The revised deal terms are better than the original agreement, including a reduced acquisition price and a secured $200 million sales agreement.
Capital raise
30 May 2024 12:17 PM
Warrant Issuance Announcement
- The company is issuing new warrants with an exercise price of $0.45 per share.
- The company expects to receive approximately $3,299,557 in gross proceeds if all new warrants are exercised.
- The proceeds are intended for capital expenditures, working capital, and general corporate purposes.
Better than expected
28 May 2024 1:37 PM
Shareholder Letter
- The company is experiencing increased interest in its products due to FDA recalls and tariffs on Chinese-made syringes, which is expected to lead to substantial revenue growth.
Better than expected
24 May 2024 4:15 PM
Material Definitive Agreement
- The company has secured a significant purchase agreement with Nephron, guaranteeing a minimum of $188.5 million in revenue over five years.
- The amended asset purchase agreement provides clarity on the cash consideration and eliminates a subordinated note, improving the financial terms of the deal.
Delay expected
24 May 2024 4:15 PM
Material Definitive Agreement
- The original Asset Purchase Agreement did not close under its original terms, leading to the need for an amendment.
Delay expected
14 May 2024 4:21 PM
Quarterly Report
- There are ongoing delays in the commercialization of the Sharps Provensa product line due to the need for further design and assembly optimization.
Worse than expected
14 May 2024 4:21 PM
Quarterly Report
- The company's net loss was worse than expected due to the lack of revenue and high operating expenses.
- The company's cash balance and working capital are lower than expected, raising concerns about its ability to continue as a going concern.
Capital raise
14 May 2024 4:21 PM
Quarterly Report
- The company intends to finance its commercialization activities and working capital needs largely from the sale of equity securities.
- The company's ability to continue as a going concern is dependent on its ability to raise sufficient financing.
Delay expected
29 March 2024 3:29 PM
Annual Results
- There continues to be delays in the commercialization of the Sharps Provensa product line.
Worse than expected
29 March 2024 3:29 PM
Annual Results
- The company's net loss increased significantly from $4.6 million in 2022 to $9.8 million in 2023.
- The company has not generated any revenue to date, indicating a lack of commercial success.
Capital raise
29 March 2024 3:29 PM
Annual Results
- The company intends to finance its future development and commercialization activities and its working capital needs largely from the sale of equity securities and/or with additional funding from other traditional financing sources.
- The company completed a securities purchase agreement in February 2023 and two simultaneous offerings in September 2023 to raise capital.
Worse than expected
19 January 2024 4:25 PM
Current Report
- The company has failed to maintain the minimum bid price and has been granted a second extension to regain compliance, indicating a continued struggle to meet listing requirements.
Disclaimer: This summary was generated by artificial intelligence and its accuracy is not guaranteed. The information provided here is for general informational purposes only and does not constitute financial advice, recommendation, or endorsement of any kind. It may contain errors or omissions. You should not rely on this information to make financial decisions. Always seek the advice of a qualified financial professional before making any investment or financial decisions. Use of this information is at your own risk.