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 year ending December 31, 2022.

Arjan Haverhals, CEO and President of Milestone Scientific, stated, “2022 was a productive year for the Company as we advanced the rollout of the CompuFlo® Epidural System across key hospitals, healthcare systems and pain management clinics. Following up on the issuance of a Category III Current Procedural Terminology (CPT®) code to identify the use of our patented technology will be a focus area in 2023. We believe this would potentially allow billing and payment pathways for healthcare personnel who choose to use our technology for coverage and discretionary payment by payers such as Medicare and Medicaid as well as commercial health plans. More recently, we received 510(k) FDA clearance for use of the CompuFlo Epidural System in the thoracic region of the spine, including the cervical thoracic junction, where the incidence rates of morbidity are believed to be much higher than in the lumbar spine region. This has helped drive the adoption of our CompuFlo Epidural System within a number of prominent pain management clinics. We were also granted registration with the U.S. Government’s System for Award Management (SAM) and are actively pursuing U.S. Federal Supply Service (FSS) approval for the CompuFlo® Epidural Instrument.”

“Within our Dental Segment, we made a number of key changes to our overall sales and marketing strategy that we believe will support and enhance our long-term growth. In the U.S., we launched a new online store for US dentists to order the STA Single Tooth Anesthesia® System Instruments and Handpieces, and ended the agreement with our prior distributor as we exited 2022.   This new site went live on January 3, 2023. While this change in US distribution strategy resulted in lower fourth quarter of 2022 sales, as the prior distributor wound down its operations, we expect our new direct online channel will provide us with a closer relationship to our customers and better margins. Additionally, we experienced continued growth in international sales, excluding China. Overall, we remain encouraged by the growing interest in both our dental and medical products.”

For the years ended December 31, 2022, and 2021, revenues were $8.8 million and $10.3 million, respectively. The decrease in revenue was driven by lower revenue from China of $1.4 million and a decrease in domestic dental revenue of $278,000, of which $179,000 related to an allowance for sales returns due to the termination of a U.S. distributor agreement. Gross profit for the year ended December 31, 2022, was $4.9 million versus $6.3 million for the year ended December 31, 2021. The year-over-year decline in gross profit was driven by lower revenue and the impact of an approximate $0.4 million non-cash inventory reserve related to medical products. Operating loss for the year ended December 31, 2022, was $8.8 million versus $7.4 million for the year ended December 31, 2021.

As of December 31, 2022, the Company had cash and cash equivalents of $8.7 million, working capital of approximately $9.7 million and no debt.

Conference Call

Milestone Scientific’s executive management team will host a conference call today, March 31, 2023, at 8:30 AM Eastern Time to discuss the Company’s financial results for the 2022 fiscal year ending December 31, 2022, 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: 333430. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2306/47967 or on the Investor Relations section of the Company’s website at https://www.milestonescientific.com/ir-calendar.

An audio replay of the call will be available through April 15, 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: 45018.

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, 2021. 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:         David Waldman or Natalya RudmanCrescendo Communications, LLCEmail: mlss@crescendo-ir.comTel: 212-671-1020

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CONSOLIDATED BALANCE SHEETS

		December 31, 2022				December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents		$	8,715,279			$	14,764,346
Accounts receivable, net			693,717				943,272
Prepaid expenses and other current assets			443,872				375,360
Inventories			1,792,335				1,541,513
Advances on contracts			1,325,301				1,309,260
Total current assets			12,970,504				18,933,751
Furniture, fixtures and equipment, net			18,146				23,713
Intangibles, net			227,956				277,619
Right of use assets			461,330				550,511
Other assets			24,150				24,150
Total assets		$	13,702,086			$	19,809,744
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	1,102,729			$	780,428
Accounts payable, related party			803,492				395,857
Accrued expenses and other payables			1,124,839				1,417,248
Accrued expenses, related party			167,549				414,241
Current portion of finance lease liabilities			9,365				8,545
Current portion of operating lease liabilities			91,701				81,001
Total current liabilities			3,299,675				3,097,320
Non-current portion of finance lease liabilities			10,698				20,062
Non-current portion of operating lease liabilities			385,279				476,980
Total liabilities		$	3,695,652			$	3,594,362
Commitments
Stockholders’ equity
Common stock, par value $.001;authorized 100,000,000 shares; 69,306,497 shares issued and 69,273,164 shares outstanding as of December 31, 2022; authorized 100,000,000 shares; 68,153,336 shares issued and 68,120,003 shares outstanding as of December 31, 2021			69,306				68,153
Additional paid in capital			127,478,325				124,915,560
Accumulated deficit			(116,410,405	)			(107,704,274	)
Treasury stock, at cost, 33,333 shares			(911,516	)			(911,516	)
Total Milestone Scientific, Inc. stockholders' equity			10,225,710				16,367,923
Noncontrolling interest			(219,276	)			(152,541	)
Total stockholders’ equity			10,006,434				16,215,382
Total liabilities and stockholders’ equity		$	13,702,086			$	19,809,744

CONSOLIDATED STATEMENTS OF OPERATIONS

YEARS ENDED DECEMBER 31,

		2022				2021
Product sales, net		$	8,805,906			$	10,304,711
Cost of products sold			3,905,092				3,992,811
Gross profit			4,900,814				6,311,900
Selling, general and administrative expenses			12,514,323				12,738,362
Research and development expenses			1,150,209				878,210
Depreciation and amortization expense			63,755				73,836
Total operating expenses			13,728,287				13,690,408
Loss from operations			(8,827,473	)			(7,378,508	)
Interest income (expense)			54,607				(16,360	)
Gain on debt extinguishment-PPP			-				276,180
Loss before provision for income taxes and equity investments			(8,772,866	)			(7,118,688	)
Provision for income taxes			-				(333	)
Loss before equity investment			(8,772,866	)			(7,119,021	)
Deferred profit and divesture-equity investment			-				242,589
Net loss			(8,772,866	)			(6,876,432	)
Net loss attributable to noncontrolling interests			66,735				58,115
Net loss attributable to Milestone Scientific Inc.		$	(8,706,131	)		$	(6,818,317	)
Net loss per share applicable to common stockholders—
Basic			(0.12	)			(0.10	)
Diluted			(0.12	)			(0.10	)
Weighted average shares outstanding and to be issued—
Basic			70,607,338				68,829,860
Diluted			70,607,338				68,829,860