MLSS Milestone Scientific Inc

Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today provides a business update and announces financial results for the first quarter ended March 31, 2024.

Arjan Haverhals, CEO and President of Milestone Scientific, stated, “I am pleased to report our domestic, direct sales strategy within our dental segment has proven effective, as a result of our new online sales portal, which recorded growth of 31% over the same period last year. As a result of the direct sales model, gross margin in the first quarter of 2024 increased to 74.5% from 72.7% for the same period last year. Although our revenue was relatively flat over the same period last year, this was largely a reflection of a reserve reversal in the first quarter of 2023, coupled with a decline in international sales during the first quarter of 2024. As previously disclosed, our focus in 2023 and early 2024 was on the domestic front; however, we have renewed our international focus heading into 2024 and anticipate improvement this year. Overall, we believe we have built a solid, scalable, high-margin dental business and are encouraged by the outlook for 2024.”

“Within our medical segment, we continue to advance our CompuFlo® Epidural System, including the commencement of disposable sales with PRC Alliance Pain Relief Center in Florida, which operates seven offices and an ambulatory surgical center (ASC), as well as Omaha Pain Physicians, a comprehensive medical pain management center in Omaha, NE. Both of these rollouts followed successful evaluation periods and 100% clinical success with zero epidural punctures. While the addition of these clinics provides further validation of our technology and strategy, the true value lies in the support these and other clinics are providing in advancing our reimbursement strategy. We have now submitted more than 160 claims to payor systems, including a variety of Medicare jurisdictions, using CPT 0777T, which builds support for our goal of reimbursement of CompuFlo. Overall, we are making meaningful progress on this initiative and I look forward to providing further updates.”

“In addition to the improved margins within our dental segment, we continue to carefully manage our expenses. Our dental business continues to generate positive cash flow on a standalone basis and we remain focused on achieving our goal of positive cash flow company wide. Moreover, we have maintained a solid balance sheet and ended the quarter with over $5 million of cash and marketable securities, which we believe provides us sufficient resources to execute on our growth strategy.”

For the three months ended March 31, 2024 and 2023, revenues were approximately $2.2 million and $2.6 million, respectively. 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, to replace its previous U.S. distribution arrangement with Henry Schein. The U.S. E-commerce revenue for the three months ended March 31, 2024 was approximately $1.3 million compared to $989,000 at March 31, 2023. The Company recorded no revenue from other U.S. distributors for the three months ended March 31, 2024 compared to approximately $219,000 for the three months ended March 31, 2023. The Company terminated all non-exclusive agreements with other distributors in the US in September 2023. For the three months ended March 31, 2024, international revenue was approximately $930,000, a decrease of $274,000, compared to March 31, 2023. 

Gross profit for the first quarter ended March 31, 2024, was $1.7 million or 75% of revenue versus $1.9 million or 73% of revenue for the first quarter ended March 31, 2023. The increase in gross profit margin was due to higher margin sales with the launch of the new online store. Operating loss for the three months ended March 31, 2024, was approximately $(1.5) million versus approximately $(1.3) million for the first quarter ended March 31, 2023. Net loss was approximately $(1.4) million, or $(0.02) per share for the three months ended March 31, 2023, versus net loss of $(1.3) million, or $(0.02) per share, for the comparable period in 2023.

As of March 31, 2024, the Company had cash, cash equivalents and short-term securities of approximately $5.0 million and working capital of approximately $7.2 million.

Conference Call

Milestone Scientific’s executive management team will host a conference call on Thursday, May 16, 2024, at 8:30 AM Eastern Time to discuss the Company’s financial results for the first quarter ended March 31, 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: 525731. A webcast and replay of the call may be accessed at Webcast URL: https://www.webcaster4.com/Webcast/Page/2306/50619.

An audio replay of the call will be available through May 30, 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: 50619.

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, 2022. 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 SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(UNAUDITED)
	March 31, 2024				December 31, 2023
ASSETS
Current assets:
Cash and cash equivalents	$	4,005,477			$	2,977,713
Marketable securities		1,000,000				2,976,573
Accounts receivable, net of allowance for credit losses of $10,000, respectively		661,838				312,664
Prepaid expenses and other current assets		863,589				517,785
Inventories		2,860,029				2,638,186
Advances on contracts		1,421,120				1,371,548
Total current assets		10,812,053				10,794,469
Furniture, fixtures and equipment, net		8,023				10,024
Intangibles, net		168,956				178,636
Right of use assets finance lease		6,835				8,998
Right of use assets operating lease		330,769				355,235
Other assets		24,150				24,150
Total assets	$	11,350,786			$	11,371,512
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,105,589			$	689,604
Accounts payable, related party		789,317				410,512
Accrued expenses and other payables		1,241,403				1,511,717
Accrued expenses, related party		170,720				137,189
Accrued Liabilities noncontrolling interest		214,000				214,000
Current portion of finance lease liabilities		8,219				10,264
Current portion of operating lease liabilities		107,355				103,427
Total current liabilities		3,636,603				3,076,713
Non-current portion of finance lease liabilities		-				434
Non-current portion of operating lease liabilities		253,774				281,853
Total liabilities	$	3,890,377			$	3,359,000
Commitments
Stockholders’ equity
Common stock, par value $0.001; authorized 100,000,000 shares; 76,632,279 shares issued and 76,598,946 shares outstanding as of March 31, 2024 shares; 75,881,840 shares issued and 75,848,507 shares outstanding as of December 31, 2023;		76,632				75,881
Additional paid in capital		133,075,331				132,187,656
Accumulated deficit		(124,780,038	)			(123,339,509	)
Treasury stock, at cost, 33,333 shares		(911,516	)			(911,516	)
Total Milestone Scientific, Inc. stockholders' equity		7,460,409				8,012,512
Total liabilities and stockholders’ equity	$	11,350,786			$	11,371,512

MILESTONE SCIENTIFIC AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR YEARS ENDED DECEMBER 31,(UNAUDITED)
		For the three months ended March 31, 2024				For the three months ended March 31, 2023
Product sales, net		$	2,248,845			$	2,597,598
Cost of products sold			572,742				708,135
Gross profit			1,676,103				1,889,463
Selling, general and administrative expenses			3,035,276				3,074,572
Research and development expenses			94,211				140,347
Depreciation and amortization expense			11,684				17,220
Total operating expenses			3,141,171				3,232,139
Loss from operations			(1,465,068	)			(1,342,676	)
Interest income (expense)			(3,351	)			23,345
Unrealized Gain Treasury investment			27,890				-
Loss before provision for income taxes			(1,440,529	)			(1,319,331	)
Provision for income taxes			-				-
Net loss			(1,440,529	)			(1,319,331	)
Net loss attributable to noncontrolling interests			-				(11,665	)
Net loss attributable to Milestone Scientific Inc.		$	(1,440,529	)		$	(1,307,666	)
Net loss per share applicable to common stockholders—
Basic and Diluted			(0.02	)			(0.02	)
Weighted average shares outstanding and to be issued—
Basic and Diluted			79,738,551				72,104,234