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 second quarter ended June 30, 2022.

Arjan Haverhals, CEO and President of Milestone Scientific, stated, “We have made significant progress rolling out our CompuFlo® Epidural System. Specifically, we have commenced sales in key hospitals, healthcare systems and pain management clinics. As an example, just last month, we were approved as a vendor within a leading medical center in Southern California, serving over 10 million members, with more than 100,000 babies delivered each year across multiple states. Moreover, our CompuFlo® Epidural System has been incorporated into the Student Registered Nurse Anesthesia (SRNA) program at the University of Scranton to educate the next generation of nurse anesthetists on the safety and economic benefits of our instruments.”

“The recent receipt of a Current Procedural Terminology (CPT®) code for the CompuFlo® Epidural System is a major milestone, and reinforces our confidence in the potential for reimbursement beyond existing codes for epidural procedures. Additionally, we have extended our network of distribution partners to assist in further adoption of CompuFlo® Epidural System. We recently added a new international distributor in Greece and re-engaged with our domestic partner, Clinical Technology, Inc. We look forward to advancing our commercialization efforts around the world, as we aim to establish the CompuFlo® Epidural System as the new standard of care. Meanwhile, we are advancing discussions with other key healthcare institutions and pain management clinics and look forward to providing near-term updates on our progress.”

“Within our Dental Segment, revenues in the U.S. market remained relatively unchanged. Internationally, excluding China and the impact of the war in Russia and Ukraine, our sales would have also been consistent with same period last year. We managed to hold sales at these levels despite significant orders for dental instruments last year to accommodate post-pandemic demand. We strategically shifted our focus away from China due to challenges with our local distributor. Historically, these sales have lower margins than other international markets. Towards this end, we continue to add third party dental distributors in other international markets and have a growing distribution network across Asia, Africa, South America, and Europe. As an example, we recently granted Hager & Werken exclusive distribution rights to market Milestone’s STA Single Tooth Anesthesia System® (STA) in Germany and Austria.”

“We remain encouraged by the outlook for the business. We ended the quarter with approximately $11 million of cash on hand and continue to carefully manage expenses. Specifically, we have reallocated additional resources towards our Medical Segment, which we believe represents the future of Milestone Scientific, while increasing our focus on third-party distributors in the Dental Segment. As a result of these and other initiatives, we have reduced our operating expenses by nearly $700 thousand in the second quarter and expect to see the benefit of additional cost reductions beginning in the third quarter of 2022. We believe this bodes well for the future as we resume revenue growth with a streamlined operating structure.”

For the three months ended June 30, 2022 and 2021, revenues were approximately $1.6 million and $2.4 million, respectively. The decrease in revenue was due to a decline in dental segment sales as a result of the Company’s strategic shift out of China, and the impact of the war in Russia and Ukraine. Gross profit for the three months ended June 30, 2022 decreased to approximately $681,000 or 41% of revenue versus $1.4 million or 56% of revenue for the second quarter of 2021. The decrease is mainly related to the Company recording an allowance of approximately $430,000 on finished goods during the three months ended June 30, 2022. Operating loss was approximately $(2.9) million for the three months ended June 30, 2022 and June 30, 2021. Net loss was approximately $(2.9) million, or $(0.04) per share for the three months ended June 30, 2022, versus net loss of $(2.7) million, or $(0.04) per share, for the comparable period in 2021.

For the six months ended June 30, 2022 and 2021, revenues were approximately $4.3 million and $5.4 million, respectively. Gross profit for the first six months of 2022 was $2.4 million versus $3.2 million for the first six months of 2021. Operating loss for the first six months of 2022 was approximately $(4.8) million versus approximately $(3.9) million for the first six months of 2021. Net loss for the first six months of 2022 was $(4.8) million, or $(0.07) per share, versus net loss of $(3.7) million, or $(0.05) per share, for the comparable period in 2021.

As of June 30, 2022, the Company had cash and cash equivalents of approximately $11.0 million, working capital of approximately $12.3 million and no long-term debt.

Conference Call

Milestone Scientific’s executive management team will host a conference call today, August 16, 2022, at 8:30 AM Eastern Time to discuss the Company’s financial results for the second quarter ended June 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 888-506-0062 for U.S. callers or +1 973-528-0011 for international callers and by entering the access code: 197590. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2306/46391 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, August 30, 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: 46391.

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

MILESTONE SCIENTIFIC AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(UNAUDITED)

	June 30, 2022				December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents	$	10,959,132			$	14,764,346
Accounts receivable, net		825,346				943,272
Accounts receivable, related party net		269,973				-
Prepaid expenses and other current assets		522,938				375,360
Inventories, net		1,505,435				1,541,513
Advances on contracts		1,630,857				1,309,260
Total current assets		15,713,681				18,933,751
Furniture, fixtures and equipment, net		16,936				23,713
Intangibles, net		250,850				277,619
Right of use assets		506,849				550,511
Other assets		24,150				24,150
Total assets	$	16,512,466			$	19,809,744
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,385,404			$	780,428
Accounts payable, related party		733,658				395,857
Accrued expenses and other payables		952,448				1,417,248
Accrued expenses, related party		222,455				414,241
Current portion of finance lease liabilities		8,946				8,545
Current portion of operating lease liabilities		86,228				81,001
Total current liabilities		3,389,139				3,097,320
Non-current portion of finance lease liabilities		15,487				20,062
Non-current portion of operating lease liabilities		432,180				476,980
Total liabilities	$	3,836,806			$	3,594,362
Commitments
Stockholders’ equity
Common stock, par value $.001;authorized 100,000,000 shares; 69,486,022 shares issued at June 30, 2022 and December 31, 2021 and 68,120,003 shares outstanding as June 30, 2022 and December 31, 2021;		68,770				68,153
Additional paid in capital		126,175,775				124,915,560
Accumulated deficit		(112,464,478	)			(107,704,274	)
Treasury stock, at cost, 33,333 shares		(911,516	)			(911,516	)
Total Milestone Scientific, Inc. stockholders' equity		12,868,551				16,367,923
Noncontrolling interest		(192,891	)			(152,541	)
Total stockholders’ equity		12,675,660				16,215,382
Total liabilities and stockholders’ equity	$	16,512,466			$	19,809,744

MILESTONE SCIENTIFIC AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(UNAUDITED)

		Three months ended June 30,								Six months ended June 30,
			2022				2021				2022				2021
Product sales, net		$	1,648,368			$	2,425,738			$	4,349,270			$	5,350,445
Cost of products sold			967,720				1,056,384				1,986,196				2,178,797
Gross profit			680,648				1,369,354				2,363,074				3,171,648
Selling, general and administrative expenses			3,282,322				4,011,672				6,397,948				6,760,969
Research and development expenses			266,560				215,420				731,027				231,864
Depreciation and amortization expense			16,645				14,834				33,460				35,760
Total operating expenses			3,565,527				4,241,926				7,162,435				7,028,593
Loss from operations			(2,884,879	)			(2,872,572	)			(4,799,361	)			(3,856,945	)
Interest income (expense)			3,550				(4,461	)			(1,193	)			(6,996	)
Gain on debt extinguishment-PPP			-				276,180				-				276,180
Loss before provision for income taxes and equity investments			(2,881,329	)			(2,600,853	)			(4,800,554	)			(3,587,761	)
Provision for income taxes			-				(83	)			-				(333	)
Loss before equity investment			(2,881,329	)			(2,600,936	)			(4,800,554	)			(3,588,094	)
Deferred profit and divesture-equity investment (See Note 6)			-				(95,857	)			-				(94,556	)
Net loss			(2,881,329	)			(2,696,793	)			(4,800,554	)			(3,682,650	)
Net loss attributable to noncontrolling interests			(22,848	)			(16,325	)			(40,350	)			(29,313	)
Net loss attributable to Milestone Scientific Inc.		$	(2,858,481	)		$	(2,680,468	)		$	(4,760,204	)		$	(3,653,337	)
Net loss per share applicable to common stockholders—
Basic			(0.04	)			(0.04	)			(0.07	)			(0.05	)
Diluted			(0.04	)			(0.04	)			(0.07	)			(0.05	)
Weighted average shares outstanding and to be issued—
Basic			70,698,014				69,220,795				70,388,765				68,286,033
Diluted			70,698,014				69,220,795				70,388,765				68,286,033