MLSS Milestone Scientific Inc

Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today provided a business update and announced financial results for the third quarter ended September 30, 2023.

Arjan Haverhals, CEO and President of Milestone Scientific, stated, “We achieved solid revenues of $2.1 million for the third quarter of 2023. Most notably, domestic dental sales increased 45%, due in part to the success of our direct sales model through the new portal for selling and shipping the STA Single Tooth Anesthesia System® (STA) and handpieces. This strategy has provided us a closer and more direct relationship with our customers, which has exceeded our expectations thus far. The new direct selling model has also resulted in an increase in gross profit for the third quarter of 2023. We achieved this growth despite a small sales force, as we are focused on maximizing profitability with a streamlined operating structure. Given the domestic traction, we are now increasing our focus on expanding our penetration within international markets. While sales to international distributors can be uneven due to the timing and size of orders, we expect our international sales to resume growth. We also look forward to announcing the addition of new international partners, which should support our global expansion strategy over the coming quarters.” 

“Turning to our medical division, we have made significant progress rolling out our CompuFlo® Epidural System. Specifically, we have added a new distributor and expanded adoption of the CompuFlo® Epidural System in a prominent hospital system and pain management clinics. Most recently, we commenced sales into Island Ambulatory Surgery Center (ASC) in Brooklyn, New York, representing the first commercial adoption of the CompuFlo® Epidural System within an ambulatory surgery center. Additionally, we are working closely with a major hospital system to expand use of the CompuFlo® Epidural System beyond labor & delivery, to now include use with neurostimulation spinal cord stimulator implantation procedures.”

"On the heels of positive reimbursement from commercial payers for patients who were involved in motor vehicle accidents, we continue to make progress advancing our broader reimbursement strategy by supporting clinicians’ utilization of the CompuFlo® technology across a variety of additional use cases. These physicians have reported back on claims activities from their payers and we are encouraged by feedback from the insurance providers to the clinicians. Moreover, the high level of claim activity that is being generated by our advisory sites is providing an opportunity to engage with the payers to directly educate them on the CompuFlo Epidural System and the unmet patient need the technology serves, including its ability to increase safety, efficiency and predictability, thus improving healthcare.”

For the three months ended September 30, 2023 and 2022, revenues were approximately $2.1 million and $2.2 million, respectively, due to an increase in domestic dental sales of $386 thousand, offset by a decrease in international dental sales of $539 thousand. Gross profit for the third quarter ended September 30, 2023, was $1.5 million, or 73% of revenue, versus $1.5 million, or 66% of revenue, for the third quarter ended September 30, 2022. The increase in gross profit was due to higher margin sales with the launch of the new online store. Operating loss for the three months ended September 30, 2023, was approximately $(1.5) million versus approximately $(2.0) million for the third quarter ended September 30, 2022. The reduction in operating loss reflects the increase in gross profit and a decrease in selling, general and administrative expenses. Net loss was approximately $(1.5) million, or $(0.02) per share for the three months ended September 30, 2023, versus net loss of $(2.0) million, or $(0.03) per share, for the comparable period in 2022.

For the nine months ended September 30, 2023 and 2022, revenues were approximately $7.6 million, a 15% increase compared to $6.6 million for the same period last year, driven by an increase in domestic dental sales of $1.3 million, partially offset by a decrease in international dental sales of $135 thousand. Gross profit for the first nine months of 2023 was $5.3 million, or 70% of revenue, versus $3.8 million, or 58% of revenue, for the first nine months of 2022. Operating loss for the first nine months of 2023 was approximately $(5.1) million versus approximately $(6.8) million for the first nine months of 2022. Net loss for the first nine months of 2023 was $(5.0) million, or $(0.07) per share, versus net loss of $(6.8) million, or $(0.10) per share, for the comparable period in 2022.

As of September 30, 2023, the Company had cash, cash equivalents and short-term securities of approximately $4.6 million and working capital of approximately $6.7 million.

Conference Call

Milestone Scientific’s executive management team will host a conference call today, Wednesday, November 15, 2023, at 8:30 AM Eastern Time to discuss the Company’s financial results for the third quarter ended September 30, 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: 164775. A webcast and replay of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2306/49471.

An audio replay of the call will be available through November 29, 2023 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: 49471.

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

(tables follow)

MILESTONE SCIENTIFIC AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(UNAUDITED)
		September 30, 2023				December 31, 2022
ASSETS			(Unaudited)
Current assets:
Cash and cash equivalents		$	2,170,593			$	8,715,279
Marketable securities			2,450,470				-
Accounts receivable, net			591,012				693,717
Prepaid expenses and other current assets			578,753				443,872
Inventories			2,482,630				1,792,335
Advances on contracts			1,699,153				1,325,301
Total current assets			9,972,611				12,970,504
Furniture, fixtures and equipment, net			9,182				18,146
Intangibles, net			188,314				227,956
Right of use assets finance lease			11,159				17,645
Right of use assets operating lease			378,142				443,685
Other assets			24,150				24,150
Total assets		$	10,583,558			$	13,702,086
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	1,149,267			$	1,102,729
Accounts payable, related party			636,637				803,492
Accrued expenses and other payables			1,111,742				1,124,839
Accrued expenses, related party			270,836				167,549
Current portion of finance lease liabilities			10,031				9,365
Current portion of operating lease liabilities			100,327				91,701
Total current liabilities			3,278,840				3,299,675
Non-current portion of finance lease liabilities			3,088				10,698
Non-current portion of operating lease liabilities			308,605				385,279
Total liabilities		$	3,590,533			$	3,695,652
Commitments
Stockholders’ equity
Common stock, par value $.001;authorized 100,000,000 shares; 70,893,748 shares issued and 70,860,415 shares outstanding as of September 30, 2023; shares; 69,306,497 shares issued and 69,273,164 shares outstanding as of December 31, 2022			70,894				69,306
Additional paid in capital			129,487,592				127,478,325
Accumulated deficit			(121,400,682	)			(116,410,405	)
Treasury stock, at cost, 33,333 shares			(911,516	)			(911,516	)
Total Milestone Scientific, Inc. stockholders' equity			7,246,288				10,225,710
Noncontrolling interest			(253,263	)			(219,276	)
Total stockholders’ equity			6,993,025				10,006,434
Total liabilities and stockholders’ equity		$	10,583,558			$	13,702,086

MILESTONE SCIENTIFIC AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(UNAUDITED)
		For the three months ended September 30, 2023				For the three months ended September 30, 2022				For the nine months ended September 30, 2023				For the nine months ended September 30, 2022
Product sales, net		$	2,059,284			$	2,215,699			$	7,566,848			$	6,564,969
Cost of products sold			555,850				762,964				2,284,730				2,749,160
Gross profit			1,503,434				1,452,735				5,282,118				3,815,809
Selling, general and administrative expenses			2,823,765				3,282,378				9,834,781				9,681,326
Research and development expenses			170,478				166,191				524,472				897,218
Depreciation and amortization expense			15,896				16,661				49,798				50,121
Total operating expenses			3,010,139				3,466,230				10,409,051				10,628,665
Loss from operations			(1,506,705	)			(2,013,495	)			(5,126,933	)			(6,812,856	)
Interest income			30,600				28,012				102,669				28,819
Loss before provision for income taxes			(1,476,105	)			(1,985,483	)			(5,024,264	)			(6,783,037	)
Provision for income taxes				-				-				-			-
Net loss			(1,476,105	)			(1,985,483	)			(5,024,264	)			(6,783,037	)
Net loss attributable to noncontrolling interests			(9,811	)			(13,680	)			(33,987	)			(54,030	)
Net loss attributable to Milestone Scientific Inc.		$	(1,466,294	)		$	(1,9718,803	)		$	(4,990,277	)		$	(6,732,007	)
Net loss per share applicable to common stockholders—
Basic and Diluted			(0.02	)			(0.03	)			(0.07	)			(0.10	)
Weighted average shares outstanding and to be issued—
Basic and Diluted			73,730,921				70,975,420				72,374,693				70,480,706