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, 2022.

Arjan Haverhals, CEO and President of Milestone Scientific, stated, “We continue to advance our commercial efforts around the CompuFlo® Epidural and CathCheck™ Verification System. As a result of our expanded sales and marketing activities, we have begun to supply our disposables to key hospitals, healthcare systems and pain management clinics. As previously disclosed, during the first quarter of 2022, the pandemic had a disproportionate impact on the labor and delivery departments within hospitals as many pregnant women opted out of the vaccine, which led to restrictions that limited our ability to demo and trial the instruments within operatories. However, with the pandemic waning, our sales initiatives have resumed, and we are making steady progress. As an example, just last month, we signed an agreement and were approved as a vendor within a major Northeast teaching hospital, which is part of one of the leading health systems in the United States. This approval follows an extensive trial and evaluation, which further validates the safety and efficacy of our technology. With the easing of pandemic restrictions, we are advancing discussions with a number of similar healthcare institutions and our sales pipeline continues to grow. We are receiving positive feedback among clinics and physicians based on our ability to achieve better outcomes at lower cost.”

“We achieved solid revenues of $2.7 million for the first quarter of 2022. The slight decline in year-over-year revenue was due in part to significant orders in the first quarter of 2021, related to pent up demand from the pandemic. Importantly, we continue to gain traction in the market and believe our decentralized, multi-channel sales strategy will help further accelerate our growth. Towards this end, we continue to add domestic and global distribution partners as well as large dental groups, also known as Dental Service Organizations (DSOs). Most recently, we added Keystone Dental Group as a strategic channel partner for the STA Single Tooth Anesthesia® System. We also established a partnership with the American Independent Dental Alliance (AIDA), America’s premier DSO network of private practice dentists, as part of a broader initiative to target the DSO market.”

“Overall, we believe we are well positioned for the balance of 2022. We have maintained a solid balance sheet to internally fund our organic growth. Our dental segment remains cash flow positive on a standalone basis and we expect to benefit from economies of scale as we continue to grow revenue due to the recurring nature and high margins on our disposables.”

For the three months ended March 31, 2022 and 2021, revenues were approximately $2.7 million and $2.9 million, respectively. Dental revenues decreased by approximately $160,000. Medical revenue decreased approximately $63,000 due to new restrictions on the labor and delivery departments within hospitals. Gross profit for the first quarter ended March 31, 2022 was $1.7 million or 62% of revenue versus $1.8 million or 62% of revenue for the first quarter ended March 31, 2021. Operating loss for the three months ended March 31, 2022 was approximately $(1.9) million versus approximately $(1.0) million for the first quarter ended March 31, 2021. The increase in operating expenses was due in part to higher sales and marketing expenses, as well as higher R&D expense related to the development of a new instrument. Net loss was approximately $(1.9) million, or $(0.03) per share for the three months ended March 31, 2022, versus net loss of $(1.0) million, or $(0.01) per share, for the comparable period in 2021.

As of March 31, 2022, the Company had cash and cash equivalents of approximately $13.3 million and working capital of approximately $14.4 million.

Conference Call

Milestone Scientific’s executive management team will host a conference call on Tuesday, May 17, 2022 at 8:30 AM Eastern Time to discuss the Company’s financial results for the first quarter ended March 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 1- 888-506-0062 for U.S. callers or +1 973-528-0011 for international callers and by entering the access code: 287705. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2306/45599 or on the Investor Relations section of the Company’s website at https://www.milestonescientific.com/investors.

An audio replay of the call will be available through Tuesday, May 31, 2022, 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: 45599.

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.

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MILESTONE SCIENTIFIC AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
		March 31,2021				December 31,2021
ASSETS
Current assets:
Cash and cash equivalents		$	13,254,775			$	14,764,346
Accounts receivable, net			1,063,613				943,272
Accounts receivable, related party net			269,973				-
Prepaid expenses and other current assets			622,080				375,360
Inventories, net			1,799,908				1,541,513
Advances on contracts			1,217,253				1,309,260
Total current assets			18,227,602				18,933,751
Furniture, fixtures and equipment, net			20,325				23,713
Intangibles, net			264,192				277,619
Right of use assets			528,907				550,511
Other assets			24,150				24,150
Total assets		$	19,065,176			$	19,809,744
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	1,012,093			$	780,428
Accounts payable, related party			1,128,919				395,857
Accrued expenses and other payables			1,335,451				1,417,248
Accrued expenses, related party			257,815				414,241
Current portion of finance leases liabilities			8,743				8,545
Current portion of operating lease liabilities			83,585				81,001
Total current liabilities			3,826,606				3,097,320
Non-current portion of finance lease liabilities			17,801				20,062
Non-current portion of operating lease liabilities			454,857				476,980
Total liabilities		$	4,299,264			$	3,594,362
Commitments and contingencies
Stockholders’ equity
Common stock, par value $.001; authorized 85,000,000 shares; 66,591,883 shares issued and 66,558,550 shares outstanding as of March 31, 2021; 64,171,435 shares issued and 64,138,102 shares outstanding as of December 31, 2020;			68,153				68,153
Additional paid in capital			125,385,315				124,915,560
Accumulated deficit			(109,605,997	)			(107,704,274	)
Treasury stock, at cost, 33,333 shares			(911,516	)			(911,516	)
Total Milestone Scientific, Inc. stockholders' equity			14,935,955				16,367,923
Noncontrolling interest			(170,043	)			(152,541	)
Total stockholders’ equity			14,765,912				16,215,382
Total liabilities and stockholders’ equity		$	19,065,176			$	19,809,744

MILESTONE SCIENTIFIC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
		For the three months endedMarch 31,
		2022				2021
Product sales, net		$	2,700,902			$	2,924,707
Cost of products sold			1,018,476				1,122,413
Gross profit			1,682,426				1,802,294
Selling, general and administrative expenses			3,115,629				2,749,299
Research and development expenses			464,466				16,444
Depreciation and amortization expense			16,814				20,924
Total operating expenses			3,596,909				2,786,667
Loss from operations			(1,914,483	)			(984,373	)
Interest expense, net			(4,742	)			(2,535	)
Loss before provision for income taxes and net of equity investments			(1,919,225	)			(986,908	)
Provision for income taxes			-				(250	)
Loss before equity in net earnings of equity investments			(1,919,225	)			(987,158	)
Income from China Joint Venture			-				1,301
Net loss			(1,919,225	)			(985,857	)
Net loss attributable to noncontrolling interests			(17,502	)			(12,988	)
Net loss attributable to Milestone Scientific Inc.		$	(1,901,723	)		$	(972,869	)
Net loss per share applicable to common stockholders—
Basic			(0.03	)			(0.01	)
Diluted			(0.03	)			(0.01	)
Weighted average shares outstanding and to be issued—
Basic			69,013,001				66,578,435
Diluted			69,013,001				66,578,435

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