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 year ending December 31, 2023.

Arjan Haverhals, CEO and President of Milestone Scientific, stated, “We achieved solid financial results in 2023, with revenue increasing 11.6% and gross profit increasing 39%. We attribute this performance to the success of our new online sales portal for the STA Single Tooth Anesthesia System® (STA) in the U.S., which has enhanced our margins, while providing us a closer relationship with our dental customers. While this was a transitional year, having terminated our prior exclusive distributor at the end of 2022, we are confident the new strategy is working and anticipate continued growth through our direct sales model. Importantly, this approach has proven effective within both individual practices, as well as Dental Service Organizations (DSOs) and large group practices. The direct sales model not only provides us greater interaction with the customer, but we are also able to provide ongoing support and education for both large and small practices. In turn, this has helped attract premier customers such as Maine Dental Group and Meridian Endo & Perio. These latest additions illustrate the benefits of our new sales strategy, as well as our ability to cost-effectively scale the business through the addition of large dental practices. Although our primary focus in 2023 was on the domestic front, we have renewed our international focus heading into 2024.”

“We are also advancing the rollout of the CompuFlo® Epidural System. Specifically, we have made progress penetrating key hospitals, and pain management clinics, including our most recent addition of Omaha Pain Physicians. We are also witnessing existing customers expand their use of CompuFlo. An important example is UTMB Health Clear Lake Campus Hospital, which has commenced use of the CompuFlo Epidural beyond labor & delivery, to now include neurostimulation spinal cord stimulator implantation procedures, illustrating the versatility and broad potential of our instrument. We also announced a distribution agreement with Bioline Supply to distribute the CompuFlo and disposables across Spain. We look forward to announcing additional distributors as we expand our global footprint.”

“Most importantly, we are making progress advancing our reimbursement strategy through a carefully staged approach. We are working closely with key pain management providers in the use of the new CPT code (0777T) for accurate and timely CompuFlo claims submission. Use of our system by these providers followed successful evaluation periods by the clinics and physicians, and in each case, they reported 100% clinical success, with zero dural punctures. I am pleased to report that our advisory sites have submitted claims for over 45 patient procedures in the first quarter of 2024 alone, which is nearly half of the claims we submitted in all of 2023. All 145 claims submitted to date, using CPT 0777T, have been successfully uploaded by payor systems for processing. We are encouraged by the accelerating claim activity that is being generated by pain management providers and have several initiatives underway that we believe will help build support for reimbursement of the CompuFlo.”

“In addition to our revenue growth and improved margins, we also reduced our loss from operations by over $1.7 million dollars. We ended the year with approximately $6.0 million of cash, cash equivalents and marketable securities, which we believe provides us more than sufficient capital to execute on our growth strategy without the need for additional funds. Overall, we are encouraged by the outlook for the business and look forward to executing on a number of key milestones in 2024 that we believe will drive value for our shareholders.”

For the years ended December 31, 2023 and 2022, revenue was approximately $9.8 million and $8.8 million, respectively, an increase of approximately $1.0 million. 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, within the U.S. E-commerce revenue for the year ended December 31, 2023, was approximately $4.8 million. The Company ended the agreement with its major United States distributor, Henry Schein, as of December 31, 2022. The Company recorded no revenue from Henry Schein for the year ended December 31, 2023, compared to approximately $2.6 million recorded for the year ended December 31, 2022. Revenue from other U.S. distributors was approximately $485,000 for the year ended December 31, 2023, a decrease of $97,000 compared to December 31, 2022. The Company terminated all non-exclusive agreements with other distributors in the US in September 2023. For the year ended December 31, 2023, international revenue was approximately $4.1 million, a decrease of $724,000 compared to December 31, 2022.

Gross profit for the year ended December 31, 2023, was $6.8 million versus $4.9 million for the year ended December 31, 2022. The increase in gross profit was due to higher margin sales with the launch of the new online store. Operating loss for the year ended December 31, 2023, was $7.1 million versus $8.8 million for the year ended December 31, 2022. The decrease in the loss from operations was driven by higher dental sales, and increased margins, which offset higher selling, general and administrative expenses during the period. Net loss was approximately $6.9 million, or $(0.10) per share for the year ended December 31, 2023, versus net loss of $8.7 million, or $(0.12) per share, for the comparable period in 2022.

As of December 31, 2023, the Company had cash, cash equivalents and marketable securities of $6.0 million, working capital of approximately $7.7 million and no debt.

Conference Call

Milestone Scientific’s executive management team will host a conference call today, Monday, April 1, 2024, at 8:30 AM Eastern Time to discuss the Company’s financial results for 2023, 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: 222156. A webcast and replay of the call may be accessed at Webcast URL: https://www.webcaster4.com/Webcast/Page/2306/50281.

An audio replay of the call will be available through April 15, 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: 50281.

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)
		December 31, 2023				December 31, 2022
ASSETS
Current assets:
Cash and cash equivalents		$	2,977,713			$	8,715,279
Marketable securities			2,976,573				-
Accounts receivable (net of allowance for credit losses of $10K at December 31, 2023 and 2022)			312,664				693,717
Prepaid expenses and other current assets			517,785				443,872
Inventories			2,638,186				1,792,335
Advances on contracts			1,371,548				1,325,301
Total current assets			10,794,469				12,970,504
Furniture, fixtures and equipment, net			10,024				18,146
Intangibles, net			178,636				227,956
Right of use assets finance lease			8,998				17,645
Right of use assets operating lease			355,235				443,685
Other assets			24,150				24,150
Total assets		$	11,371,512			$	13,702,086
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	689,604			$	1,102,729
Accounts payable, related party			410,512				803,492
Accrued expenses and other payables			1,511,717				1,124,839
Accrued expenses, related party			137,189				167,549
Accrued liabilities noncontrolling interests			214,000				-
Current portion of finance lease liabilities			10,264				9,365
Current portion of operating lease liabilities			103,427				91,701
Total current liabilities			3,076,713				3,299,675
Non-current portion of finance lease liabilities			434				10,698
Non-current portion of operating lease liabilities			281,853				385,279
Total liabilities		$	3,359,000			$	3,695,652
Stockholders’ equity
Common stock, par value $.001; authorized 100,000,000 shares; 75,881,840 shares issued and 75,848,507 shares outstanding as of December 31, 2023 shares; 69,306,497 shares issued and 69,273,164 shares outstanding as of December 31, 2022;			75,881				69,306
Additional paid in capital			132,187,656				127,478,325
Accumulated deficit			(123,339,509	)			(116,410,405	)
Treasury stock, at cost, 33,333 shares			(911,516	)			(911,516	)
Total Milestone Scientific, Inc. stockholders' equity			8,012,512				10,225,710
Noncontrolling interest			-				(219,276	)
Total stockholders’ equity			8,012,512				10,006,434
Total liabilities and stockholders’ equity		$	11,371,512			$	13,702,086

 

MILESTONE SCIENTIFIC AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR YEARS ENDED DECEMBER 31,(UNAUDITED)
			2023				2022
Product sales, net		$	9,827,444			$	8,805,906
Cost of products sold			3,034,832				3,905,092
Gross profit			6,792,612				4,900,814
Selling, general and administrative expenses			13,135,796				12,514,323
Research and development expenses			701,378				1,150,209
Depreciation and amortization expense			61,912				63,755
Total operating expenses			13,899,086				13,728,287
Loss from operations			(7,106,474	)			(8,827,473	)
Interest income (expense)			125,527				54,607
Provision for income Taxes			-				-
Loss before provision for income taxes			(6,980,947	)			(8,772,866	)
Net loss			(6,980,947	)			(8,772,866	)
Net loss attributable to noncontrolling interests			(51,843	)			(66,735	)
Net loss attributable to Milestone Scientific Inc.		$	(6,929,104	)		$	(8,706,131	)
Net loss per share applicable to common stockholders—
Basic and Diluted			(0.10	)			(0.12	)
Weighted average shares outstanding and to be issued—
Basic and Diluted			72,775,781				70,607,338