ROSELAND, N.J., April 01, 2022 (GLOBE NEWSWIRE) -- 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 full year ending December 31, 2021.

Arjan Haverhals, CEO and President of Milestone Scientific, stated, "I am pleased to report we achieved 90% year-over-year growth in revenue to $10.3 million, surpassing our prior revenue guidance and exceeding pre-pandemic levels. The growth in our dental division reflects the success of our sales and marketing initiatives, as well as the expansion of our distribution network. We are encouraged by the growing interest in our dental instrument, and expect our momentum to continue in 2022. Importantly, the dental division remains profitable on a standalone basis with high gross margins, and we expect to benefit from economies of scale as we continue to carefully manage our expenses."

"We have made progress over the past year rolling out our CompuFlo® Epidural System. Specifically, we added new distributors and have begun to penetrate key hospitals, healthcare systems and pain management clinics. In December alone, immediately preceding the spike in Omicron cases, we announced the addition of three leading hospitals, all of which belong to large healthcare systems. It is important to note that the pandemic had a disproportionate impact on the labor and delivery departments within hospitals, as many pregnant women opted out of the vaccine. This resulted in stricter restrictions than other departments, which limited our ability to demo and trial the instruments within the operatories. With the pandemic and Omicron variant now waning, the restrictions have begun to ease, and we are aggressively resuming activities, albeit delayed by several months."

"At the same time, we have expanded our focus to include pain management centers, which were less impacted by the pandemic. For instance, this week, we announced an agreement with Pain Management Specialists in California, and are now selling our disposables in the first two of their three clinics. Similarly, we announced that a leading pain management specialist, Dr. Harsh Govil, has begun using our technology within his practice at Piedmont Healthcare. Similarly, Dr. Miguel de la Garza, a recognized leader in pain management and president of the Florida Society of Interventional Pain Physicians, has begun using our technology within his practice. He conducts these procedures at Surgery Partners, which has also approved the CompuFlo Epidural instrument for use across their network in pain management."

"We remain committed to our goal of establishing the CompuFlo Epidural instrument as the new standard of care in epidural anesthesia by providing patients with effective pain relief, while reducing the risk of complications. Moreover, we have a strong cash runway with over $14.8 million of cash and cash equivalents as of December 31, 2021. This liquidity, combined with our improving cash flow, will support our ongoing activities, including accelerated marketing activities around both our dental and medical instruments."

For the years ended December 31, 2021 and 2020, revenues were approximately $10.3 million and $5.4 million, respectively. Dental revenue increased approximately $4.7 million for the year ended December 31, 2021, as compared to 2020, due to the re-opening of dental offices throughout the country, and the rest of the world, including China. Medical revenue increased approximately $136,000 for the year ended December 31, 2021, as compared to 2020 due to the Company arranging meetings at hospital and pain clinics through the direct sales force and medical device distributors in European markets. Gross profit for the year ended December 31, 2021 was $6.3 million or 61% of revenue versus $3.6 million or 67% of revenue for the year ended December 31, 2020. Operating loss for the year ended December 31, 2021 was approximately $(7.4) million versus approximately $(7.5) million for the year ended December 31, 2020. Net loss attributable to common shareholders was approximately $(6.8) million, or $(0.10) per share for the year ended December 31, 2021, versus net loss attributable to common shareholders of $(7.3) million, or $(0.12) per share, for the comparable period in 2020.

Conference Call

Milestone Scientific's executive management team will host a conference call at 8:30 AM Eastern Time on Friday, April 1, 2022 to discuss the Company's financial results for the 2021 fiscal year ending December 31, 2021, 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: 639488. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2306/45018 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 April 15, 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: 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.

(tables follow)

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

	December 31, 2021			December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	14,764,346		$	14,223,917
Accounts receivable, net		943,272			1,080,656
Prepaid expenses and other current assets		375,360			415,915
Inventories, net		1,541,513			2,420,179
Advances on contracts		1,309,260			414,202
Total current assets		18,933,751			18,554,869
Furniture, fixtures and equipment, net		23,713			30,729
Intangibles, net		277,619			329,249
Right of use assets		550,511			632,453
Other assets		24,150			24,150
Total assets	$	19,809,744		$	19,571,450

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	780,428		$	482,972
Accounts payable, related party		395,857			385,138
Accrued expenses and other payables		1,417,248			824,454
Accrued expenses, related party		414,241			586,734
Current portion of finance lease liabilities		8,545			7,796
Current portion of operating lease liabilities		81,001			72,031
Deferred profit, related party		-			242,589
Note payable		-			276,180
Total current liabilities		3,097,320			2,877,894
Non-current portion of finance lease liabilities		20,062			28,607
Non-current portion of operating lease liabilities		476,980			557,981
Total liabilities	$	3,594,362		$	3,464,482

Stockholders' equity
Common stock, par value $.001;authorized 100,000,000 shares; 68,153,336 shares issued and 68,120,003 shares outstanding as December 31, 2021; authorized 85,000,000 shares; 64,171,435 shares issued and 64,138,102 shares outstanding as December 31, 2020;		68,153			64,171
Additional paid in capital		124,915,560			117,934,696
Accumulated deficit		(107,704,274	)		(100,885,957	)
Treasury stock, at cost, 33,333 shares		(911,516	)		(911,516	)
Total Milestone Scientific Inc. stockholders' equity		16,367,923			16,201,394
Noncontrolling interest		(152,541	)		(94,426	)
Total stockholders' equity	$	16,215,382		$	16,106,968

Total liabilities and stockholders' equity	$	19,809,744		$	19,571,450

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

YEARS ENDED DECEMBER 31,

	2021			2020

Product sales, net	$	10,304,711		$	5,437,236
Cost of products sold		3,992,811			1,815,924
Gross profit		6,311,900			3,621,312

Selling, general and administrative expenses		12,738,362			10,670,631
Research and development expenses		878,210			307,850
Depreciation and amortization expense		73,836			95,949
Total operating expenses		13,690,408			11,074,430
Loss from operations		(7,378,508	)		(7,453,118	)

Interest expense, net		(16,360	)		(18,081	)
Gain on debt extinguishment-PPP		276,180			-
Loss before provision for income taxes and net of equity investments		(7,118,688	)		(7,471,199	)
Provision for income taxes		(333	)		(15,500	)
Loss before equity investment		(7,119,021	)		(7,486,699	)
Deferred profit and divesture-equity investment		242,589			97,887
Net loss		(6,876,432	)		(7,388,812	)
Net loss attributable to noncontrolling interests		58,115			51,539
Net loss attributable to Milestone Scientific Inc.		(6,818,317	)		(7,337,273	)

Net loss per share applicable to common stockholders—
Basic	$	(0.10	)	$	(0.12	)
Diluted	$	(0.10	)	$	(0.12	)

Weighted average shares outstanding and to be issued—
Basic		68,829,860			63,061,358
Diluted		68,829,860			63,061,358

Contact:

David Waldman or Natalya Rudman

Crescendo Communications, LLC

Email: mlss@crescendo-ir.com

Tel: 212-671-1020

Milestone Scientific Reports 90% Year-Over-Year Revenue Growth and Provides 2021 Year-End Business Update