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 first quarter ended March 31, 2023.

Arjan Haverhals, CEO and President of Milestone Scientific, stated, “We achieved solid revenues of $2.6 million for the first quarter of 2023. Most notably, domestic dental sales increased 47%, due in part to the early success of our new online store for selling and shipping the STA Single Tooth Anesthesia System® (STA) and handpieces directly to dental offices and dental groups within the U.S. This strategy has provided us a closer and more direct relationship with our customers, which, in turn, resulted in an increase in gross profit for the first quarter of 2023. Despite our focus on the domestic market this quarter, we expect our strategy to enter new international markets and deepen our penetration within existing international markets will support our growth over the coming quarters.”

“We continue to advance our commercial efforts around the CompuFlo® Epidural System, as we target hospitals, healthcare systems and pain management clinics. Moreover, the recent FDA clearance of our instrument for use in the thoracic region of the spine, including the cervical thoracic junction, is also helping drive interest in our technology given the added complexity and risks associated with these procedures. Most recently, we commenced sales of CompuFlo® Epidural disposables into the Regenerative Sports and Spine Center in Tualatin, Oregon. I am pleased to report that these procedures, along with others we commenced earlier this year, mark the first in a series of epidural steroid injections using the CompuFlo Epidural System by physicians under the new American Medical Association (AMA) Current Procedural Terminology (CPT®) guidelines for AI assisted analgesic epidural needle placement in patients.   We believe that the efforts we are taking to educate leading anesthesiologists and pain specialists will ultimately lead to increased adoption given the proven safety and economic benefits of our technology.”

For the three months ended March 31, 2023 and 2022, revenues were approximately $2.6 million and $2.7 million, respectively. The decrease in revenue was driven by lower revenue from China of $360,000 and a decrease in international sales of $186,000, partially offset by an increase in domestic dental revenue of $443,400. Gross profit for the first quarter ended March 31, 2023, was $1.9 million or 73% of revenue versus $1.7 million or 62% of revenue for the first quarter ended March 31, 2022. The increase was due to higher margin sales with the launch of the new online store. Operating loss for the three months ended March 31, 2023, was approximately $(1.3) million versus approximately $(1.9) million for the first quarter ended March 31, 2022, due in part to higher margins in dental sales and a reduction in research and development cost. Net loss was approximately $(1.3) million, or $(0.02) per share for the three months ended March 31, 2023, versus net loss of $(1.9) million, or $(0.03) per share, for the comparable period in 2022.

As of March 31, 2023, the Company had cash, cash equivalents and short-term securities of approximately $6.7 million and working capital of approximately $8.9 million.

Conference Call

Milestone Scientific’s executive management team will host a conference call on Thursday, May 11, 2023, at 8:30 AM Eastern Time to discuss the Company’s financial results for the first quarter ended March 31, 2023, as well as the Company’s corporate progress and other developments.

The conference call will be available via telephone by dialing toll free 877-545-0523 for U.S. callers or +1 973-528-0016 for international callers and by entering the access code: 969476. A webcast and replay of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2306/48364.

An audio replay of the call will be available through May 25, 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: 48364.

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, dental and cosmetic 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, 2023				December 31, 2022
ASSETS
Current assets:
Cash and cash equivalents		$	2,277,953			$	8,715,279
Short-term investments			4,430,384				-
Accounts receivable, net			912,399				693,717
Prepaid expenses and other current assets			767,430				443,872
Inventories, net			2,038,298				1,792,335
Advances on contracts			1,154,826				1,325,301
Total current assets			11,581,290				12,970,504
Furniture, fixtures and equipment, net			15,333				18,146
Intangibles, net			214,742				227,956
Right of use assets finance lease			15,483				17,645
Right of use assets finance lease			422,355				443,685
Other assets			24,150				24,150
Total assets		$	12,273,353			$	13,702,086
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	823,907			$	1,102,729
Accounts payable, related party			451,572				803,492
Accrued expenses and other payables			1,032,533				1,124,839
Accrued expenses, related party			240,830				167,549
Current portion of finance leases liabilities			9,582				9,365
Current portion of operating lease liabilities			94,532				91,701
Total current liabilities			2,652,955				3,299,675
Non-current portion of finance lease liabilities			8,219				10,698
Non-current portion of operating lease liabilities			360,304				385,279
Total liabilities		$	3,021,478			$	3,695,652
Commitments and contingencies
Stockholders’ equity
Common stock, par value $.001; authorized 100,000,000 shares; 69,741,657 shares issued and 69,965,192 shares outstanding as of March 31, 2023; 69,306,497 shares issued and 69,273,164 shares outstanding as of December 31, 2022;			69,774				69,306
Additional paid in capital			128,042,629				127,478,325
Accumulated deficit			(117,718,071	)			(116,410,405	)
Treasury stock, at cost, 33,333 shares			(911,516	)			(911,516	)
Total Milestone Scientific, Inc. stockholders' equity			9,482,816				10,225,710
Noncontrolling interest			(230,941	)			(219,276	)
Total stockholders’ equity			9,251,875				10,006,434
Total liabilities and stockholders’ equity		$	12,273,353			$	13,702,086

MILESTONE SCIENTIFIC AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(UNAUDITED)

		For the three months ended March 31,
		2023				2022
Product sales, net		$	2,597,598			$	2,700,902
Cost of products sold			708,135				1,018,476
Gross profit			1,889,463				1,682,426
Selling, general and administrative expenses			3,074,572				3,115,629
Research and development expenses			140,347				464,466
Depreciation and amortization expense			17,220				16,814
Total operating expenses			3,232,139				3,596,909
Loss from operations			(1,342,676	)			(1,914,483	)
Interest income (expense)			(23,345	)			(4,742	)
Loss before provision for income taxes			(1,319,331	)			(1,919,225	)
Provision for income taxes			-				-
Net loss			(1,319,331	)			(1,919,225	)
Net loss attributable to noncontrolling interests			(11,665	)			(17,502	)
Net loss attributable to Milestone Scientific Inc.		$	(1,307,666	)		$	(1,901,723	)
Net loss per share applicable to common stockholders—
Basic and Diluted			(0.02	)			(0.03	)
Weighted average shares outstanding and to be issued—
Basic and Diluted			70,668,813				69,013,001