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, 2022.

Arjan Haverhals, CEO and President of Milestone Scientific, stated, “I am pleased to report we achieved both sequential and year-over-year revenue growth for third quarter of 2022. Although our dental segment faced temporary challenges in the second quarter of 2022, due in part to the challenging situation in China and the Russia-Ukraine war, we are back on a solid growth trajectory in the third quarter with sequential sales growth of 34.4% over the second quarter of 2022. In addition, our revenue for the third quarter of 2022, increased 28.6% over the same period last year, excluding sales to China. This growth reflects the success of our expanded sales and marketing activities.”  

“Turning out to our medical division, we continue to advance our commercial efforts around the CompuFlo® Epidural and CathCheck® Verification System. Specifically, we added new distributors and have commenced sales in key hospitals, healthcare systems and pain management clinics. As an example, in August we began implementing the CompuFlo Epidural System at UofL Health (University of Louisville) across three distinct departments: labor & delivery, acute pain and in the operating room. Moreover, we believe that the recent issuance of a Category III Current Procedural Terminology (CPT®) code to identify the use of our patented technology, which goes into effect on January 1, 2023, would allow billing and payment pathways for health care 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. We believe that reimbursement would aid in the financial decision making process, within both private pain clinics and hospital settings, thereby potentially helping to accelerate our commercial rollout. In the meantime, we continue to advance discussions with other key healthcare institutions and pain management clinics.”

“We have taken steps to further streamline operations and continue to carefully manage expenses, which should result in improved performance as we continue to grow revenues. At the same time, we have maintained a solid balance sheet with approximately $9.8 million of cash and cash equivalents on hand. Overall, we remain encouraged by the outlook for the business and remain focused on driving value for shareholders.”

For the three months ended September 30, 2022 and 2021, revenues were approximately $2.2 million and $2.1 million, respectively. Gross profit for the three months ended September 30, 2022 was $1.5 million versus $1.4 million for the third quarter of 2021. Operating loss was approximately $(2.0) million for the three months ended September 30, 2022 and September 30, 2021. Net loss was approximately $(2.0) million or $(0.03) per share for the three months ended September 30, 2022 and September 30, 2021.

For the nine months ended September 30, 2022 and 2021, revenues were approximately $6.6 million and $7.5 million, respectively. Gross profit for the first nine months of 2022 was $3.8 million versus $4.5 million for the first nine months of 2021. Operating loss for the first nine months of 2022 was approximately $(6.8) million versus approximately $(5.8) million for the first nine months of 2021. Net loss for the first nine months of 2022 was $(6.7) million, or $(0.10) per share, versus net loss of $(5.7) million, or $(0.08) per share, for the comparable period in 2021.

As of September 30, 2022, the Company had cash and cash equivalents of approximately $9.8 million, working capital of approximately $10.8 million and no long-term debt.

Conference Call

Milestone Scientific’s executive management team will host a conference call today, November 15, 2022, at 8:30 AM Eastern Time to discuss the Company’s financial results for the third quarter ended September 30, 2022, 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 +1 973-528-0016f or international callers and by entering the access code: 570917. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2306/47097or 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, November 29, 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: 47097.

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 SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(UNAUDITED)

		September 30, 2022				December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents		$	9,811,673			$	14,764,346
Accounts receivable, net			1,091,729				943,272
Accounts receivable, related party net			-				-
Prepaid expenses and other current assets			478,218				375,360
Inventories			1,551,842				1,541,513
Advances on contracts			1,581,483				1,309,260
Total current assets			14,514,945				18,933,751
Furniture, fixtures and equipment, net			17,401				23,713
Intangibles, net			237,636				277,619
Right of use assets			484,327				550,511
Other assets			24,150				24,150
Total assets		$	15,278,459			$	19,809,744
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	1,282,720			$	780,428
Accounts payable, related party			910,999				395,857
Accrued expenses and other payables			1,050,173				1,417,248
Accrued expenses, related party			333,483				414,241
Current portion of finance lease liabilities			9,153				8,545
Current portion of operating lease liabilities			88,933				81,001
Total current liabilities			3,675,461				3,097,320
Non-current portion of finance lease liabilities			13,120				20,062
Non-current portion of operating lease liabilities			408,998				476,980
Total liabilities		$	4,097,579			$	3,594,362
Commitments
Stockholders’ equity
Common stock, par value $.001; authorized 100,000,000 shares; 68,907,394 and 68,153,336 shares issued on September 30, 2022, and December 31, 2021, and 68,874,061 and 68,120,003, shares outstanding as September 30, 2022, and December 31, 2021.		$	68,907			$	68,153
Additional paid in capital			126,666,340				124,915,560
Accumulated deficit			(114,436,281	)			(107,704,274	)
Treasury stock, at cost, 33,333 shares			(911,516	)			(911,516	)
Total Milestone Scientific, Inc. stockholders' equity			11,387,451				16,367,923
Noncontrolling interest			(206,571	)			(152,541	)
Total stockholders’ equity			11,180,879				16,215,382
Total liabilities and stockholders’ equity		$	15,278,459			$	19,809,744

MILESTONE SCIENTIFIC AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(UNAUDITED)

		Three months endedSeptember 30,								Nine months endedSeptember 30,
		2022				2021				2022				2021
Product sales, net		$	2,215,699			$	2,108,233			$	6,564,969			$	7,458,678
Cost of products sold			762,964				747,997				2,749,160				2,926,794
Gross profit			1,452,735				1,360,236				3,815,809				4,531,884
Selling, general and administrative expenses			3,283,378				2,968,625				9,681,326				9,729,594
Research and development expenses			166,191				356,179				897,218				588,043
Depreciation and amortization expense			16,661				16,353				50,121				52,113
Total operating expenses			3,466,230				3,341,157				10,628,665				10,369,750
Loss from operations			(2,013,495	)			(1,980,921	)			(6,812,856	)			(5,837,866	)
Interest income (expense)			28,012				(4,608	)			26,819				(11,604	)
Gain on debt extinguishment-PPP			-				-				-				276,180
Loss before provision for income taxes and equity investments			(1,985,483	)			(1,985,529	)			(6,786,037	)			(5,573,290	)
Provision for income taxes			-				-				-				(333	)
Loss before equity investment			(1,985,483	)			(1,985,529	)			(6,786,037	)			(5,573,623	)
Deferred profit and divesture-equity investment			-				(69,905	)			-				(164,461	)
Net loss			(1,985,483	)			(2,055,434	)			(6,786,037	)			(5,738,084	)
Net loss attributable to noncontrolling interests			(13,680	)			(12,227	)			(54,030	)			(41,540	)
Net loss attributable to Milestone Scientific Inc.		$	(1,971,803	)		$	(2,043,207	)		$	(6,732,007	)		$	(5,696,544	)
Net loss per share applicable to common stockholders—
Basic			(0.03	)			(0.03	)			(0.10	)			(0.08	)
Diluted			(0.03	)			(0.03	)			(0.10	)			(0.08	)
Weighted average shares outstanding and to be issued—
Basic			70,975,420				69,573,795				70,480,706				68,609,143
Diluted			70,975,420				69,573,795				70,480,706				68,609,143

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