MLSS Milestone Scientific Inc

Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today reported financial results for the third quarter ended September 30, 2024.

Arjan Haverhals, CEO of Milestone Scientific, commented, “We are pleased to report a 22% year-over-year increase in total revenue, reaching $2.5 million for the third quarter of 2024. This growth was primarily driven by robust performance in our dental segment, where international dental sales rose by an impressive 57%, supported by strong demand in the domestic market. Our focus on expanding global distribution and leveraging our e-commerce platform continues to accelerate dental product adoption and reinforces our leadership in this space. In addition to our revenue growth, we recorded a gross margin of 73%, further validating the benefits of our direct sales model through the new online portal.”

“Within our medical segment, the recent achievement of a granted Medicare Part B Physician payment rate with First Coast Service Options Inc. (FCSO) and Novitas Solutions, Inc. for the CompuFlo® Epidural System under the American Medical Association’s (AMA) technology-specific Category III CPT® code CPT0777T (real-time pressure-sensing epidural guidance system when used in conjunction with a primary ESI procedure) has catalyzed a new wave of interest. We are also benefitting from our recent strategic partnership with Axial Biologics to distribute the CompuFlo® in New Jersey, Texas, and Florida.  As a result, premier clinics such as Hudson Specialty Care and iHEAL Pain Center, have adopted the CompuFlo® Epidural System, underscoring the system’s increasing traction among top pain management providers. We are encouraged by our growing sales pipeline with additional pilot programs underway. We are also advancing discussion within additional Jurisdictional Medicare Administrative Contractors (JMAC) regions to further expand our coverage and we look forward to providing further updates. Looking ahead, we are dedicated to accelerating the rollout of the CompuFlo® Epidural System in both the domestic and international markets. At the same time, we remain focused on driving value for shareholders as we aim to set new standards in patient care across the pain management sector.”

For the three months ended September 30, 2024, and 2023, revenues were approximately $2.5 million and $2.1 million, respectively, an increase of approximately $0.5 million. As of January 3, 2023, the Company launched an e-commerce platform, selling and shipping the STA Single Tooth Anesthesia System® (STA) and handpieces directly to end users, including dental offices and dental groups. The U.S. e-commerce and dental services revenue for the three months ended September 30, 2024 and 2023, was approximately $1.2 million, respectively. The Company recorded no revenue from other U.S. distributors for the three months ended September 30, 2024 compared to approximately $48,000 for the three months ended September 30, 2023. The Company terminated all non-exclusive agreements with other distributors in the U.S. in September 2023. For the three months ended September 30, 2024, international revenue was approximately $1.3 million, an increase of approximately $0.5 million, compared to September 30, 2023. International sales increased due to the Company resolving the freight forwarder delays from the previous quarter. The Company recorded no revenue from China for the three months ended September 30, 2024 and 2023. Gross profit for the third quarter ended September 30, 2024, was $1.8 million, or 73% of revenue, versus $1.5 million, or 73% of revenue, for the third quarter ended September 30, 2023. The increase in gross profit was due to higher international sales. Operating loss for both the three months ended September 30, 2024 and 2023, was approximately $(1.5) million, respectively, a decrease of approximately $38,000. Net loss for the three months ended September 30, 2024 and 2023 was approximately $(1.5) million, or $(0.02) per share, respectively.

For the nine months ended September 30, 2024, and 2023, revenue was approximately $6.6 million and $7.6 million, respectively. The U.S. e-commerce and dental service revenue for the nine months ended September 30, 2024 was approximately $3.9 million compared to $3.5 million at September 30, 2023, an increase of approximately $0.4 million. The Company terminated its remaining U.S. distributor in September 2023. The Company recorded no revenue from other U.S. distributors for the nine months ended September 30, 2024 compared to approximately $480,000 for the nine months ended September 30, 2023. For the nine months ended September 30, 2024, international revenue was approximately $2.7 million, a decrease of $0.6 million, compared to September 30, 2023. International sales decreased due to issues with freight forwarders carrier during the previous quarter. The Company recorded no revenue from China for the nine months ended September 30, 2024 compared to approximately $270,000 for the nine months ended September 30, 2023. Gross profit for the first nine months of 2024 was $4.9 million, or 74% of revenue, versus $5.3 million, or 70% of revenue, for the first nine months of 2023. The decrease in gross profit was due to lower international sales offset by the Company higher margins in sales associated with the launch of e-commerce platform. Operating loss for the first nine months of 2024 was approximately $(4.7) million versus approximately $(5.1) million for the first nine months of 2023. Net loss for the first nine months of 2024 was $(2.7) million, or $(0.03) per share, versus net loss of $(5.0) million, or $(0.07) per share per share for the comparable period in 2023. The decrease in net loss was primarily driven by the Company’s receipt of approximately $2.0 million, net of expenses, from the sale of New Jersey net operating losses (“NOL”).

As of September 30, 2024, the Company had cash and cash equivalents of approximately $4.8 million and working capital of approximately $6.9 million.

Conference Call

Milestone Scientific’s executive management team will host a conference call on Friday, November 15, 2024 at 8:30 AM Eastern Time to discuss the Company’s financial results for the third quarter ended September 30, 2024, as well as the Company’s corporate progress and other developments.

The conference call will be available via telephone by dialing toll free 888-506-0062 for U.S. callers or +1 973-528-0011 for international callers and by entering the access code: 169295. A webcast and replay of the call may be accessed at Webcast URL: https://www.webcaster4.com/Webcast/Page/2306/51651.

An audio replay of the call will be available through Friday, November 29, 2024, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and by entering the access code: 51651.

About Milestone Scientific Inc.Milestone Scientific Inc. (MLSS), a technology focused medical research and development company that patents, designs and develops innovative injection technologies and instruments for medical and dental applications. Milestone Scientific’s computer-controlled systems are designed to make injections precise, efficient and increase the overall patient comfort and safety. Their proprietary DPS Dynamic Pressure Sensing Technology® instruments is the platform to advance the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions of subcutaneous drug delivery, including local anesthetic. To learn more, view the MLSS brand video or visit milestonescientific.com.

Safe Harbor Statement

This press release contains forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues, timing of regulatory approvals and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions, future business decisions and regulatory developments, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and the risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including without limitation, Milestone's Annual Report for the year ended December 31, 2023. The forward-looking statements in this press release are based upon management's reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

Contact:Crescendo Communications, LLCEmail: mlss@crescendo-ir.comTel: 212-671-1020

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MILESTONE SCIENTIFIC AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
		September 30, 2024				December 31, 2023
ASSETS		(Unaudited)
Current assets:
Cash and cash equivalents		$	4,775,597			$	2,977,713
Marketable securities			-				2,976,573
Accounts receivable, net of allowance for credit losses of $10,000, respectively			550,969				312,664
Accounts receivable, related party net			3,013				-
Prepaid expenses and other current assets			646,130				517,785
Inventories			3,711,636				2,638,186
Advances on contracts			1,011,306				1,371,548
Total current assets			10,698,651				10,794,469
Furniture, fixtures and equipment, net			11,265				10,024
Intangibles, net			155,255				178,636
Right of use assets finance lease			2,511				8,998
Right of use assets operating lease			283,086				355,235
Other assets			24,150				24,150
Total assets		$	11,174,918			$	11,371,512
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	1,138,060			$	689,604
Accounts payable, related party			740,017				410,512
Accrued expenses and other payables			1,267,718				1,511,717
Accrued expenses, related party			281,947				137,189
Accrued liabilities noncontrolling interest			214,000				214,000
Current portion of finance lease liabilities			3,088				10,264
Current portion of operating lease liabilities			112,955				103,427
Total current liabilities			3,757,785				3,076,713
Non-current portion of finance lease liabilities			-				434
Non-current portion of operating lease liabilities			195,649				281,853
Total liabilities		$	3,953,434			$	3,359,000
Commitments and contingencies
Stockholders’ equity
Common stock, par value $0.001; authorized 100,000,000 shares; 77,709,455 shares issued and 77,676,122 shares outstanding as of September 30, 2024; 75,881,840 shares issued and 75,848,507 shares outstanding as of December 31, 2023;			77,710				75,881
Additional paid in capital			134,072,861				132,187,656
Accumulated deficit			(126,017,571	)			(123,339,509	)
Treasury stock, at cost, 33,333 shares			(911,516	)			(911,516	)
Total Milestone Scientific, Inc. stockholders' equity			7,221,484				8,012,512
Total liabilities and stockholders’ equity		$	11,174,918			$	11,371,512

MILESTONE SCIENTIFIC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
		For the three months ended September 30, 2024				For the three months ended September 30, 2023				For the nine months ended September 30, 2024				For the nine months ended September 30, 2023
Product sales, net		$	2,513,805			$	2,059,284			$	6,616,414			$	7,566,848
Cost of products sold			677,585				555,850				1,692,888				2,284,730
Gross profit			1,836,220				1,503,434				4,923,526				5,282,118
Selling, general and administrative expenses			3,064,769				2,823,765				8,968,226				9,834,781
Research and development expenses			232,056				170,478				641,235				524,472
Depreciation and amortization expense			8,574				15,896				28,735				49,798
Total operating expenses			3,305,399				3,010,139				9,638,196				10,409,051
Loss from operations			(1,469,179	)			(1,506,705	)			(4,714,670	)			(5,126,933	)
Interest income			8,008				30,600				53,513				102,669
Gain on sale of net operating losses			-				-				1,983,095				-
Loss before provision for income taxes			(1,461,171	)			(1,476,105	)			(2,678,062	)			(5,024,264	)
Net loss			(1,461,171	)			(1,476,105	)			(2,678,062	)			(5,024,264	)
Net loss attributable to noncontrolling interests		$	-			$	(9,811	)		$	-			$	(33,987	)
Net loss attributable to Milestone Scientific Inc.		$	(1,461,171	)		$	(1,466,294	)		$	(2,678,062	)		$	(4,990,277	)
Net loss per share applicable to common stockholders—
Basic and Diluted			(0.02	)			(0.02	)			(0.03	)			(0.07	)
Weighted average shares outstanding and to be issued—
Basic and diluted			79,966,833				73,730,921				80,165,181				72,374,693