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, 2023.

Arjan Haverhals, CEO and President of Milestone Scientific, stated, “I am pleased to report that we achieved strong year-over-year and sequential revenue growth for the second quarter of 2023. Revenue for the second quarter increased 77% to $2.9 million, while gross profit increased 178% over the same period last year. We attribute this strong performance to the success of our new online store, which has provided us a closer and more direct relationship with our customers. In addition, we saw a meaningful increase in international dental sales.”

“Turning to our medical division, we continue to advance the rollout of the CompuFlo® Epidural System. Most importantly, we announced positive reimbursement was received from commercial payers for patients who were involved in motor vehicle accidents. Although receipt of reimbursement is encouraging and opens the door to approval for other use cases, on its own, these initial payments do not yet confer broad coverage for other epidural procedures. We believe these approvals represent an important validation of our technology and reimbursement strategy. Although this process takes time, we continue to expand the foundation of physicians utilizing our technology, which is building support for the appropriate level of reimbursement from insurance providers.”

For the three months ended June 30, 2023 and 2022, revenues were approximately $2.9 million and $1.6 million, respectively, driven by an increase in domestic dental sales of $444 thousand, an increase in international dental sales of $589 thousand, and dental revenue from China of $270 thousand. Gross profit for the second quarter ended June 30, 2023, was $1.9 million, or 65% of revenue, versus $681 thousand, or 41% of revenue, for the second quarter ended June 30, 2022. The increase in gross profit was due to higher margin sales with the launch of the new online store. Operating loss for the three months ended June 30, 2023, was approximately $(2.3) million versus approximately $(2.9) million for the second quarter ended June 30, 2022. The reduction in operating loss reflects the increase in revenue and gross profit, partially offset by an increase in selling, general and administrative expenses. Net loss was approximately $(2.2) million, or $(0.03) per share for the three months ended June 30, 2023, versus net loss of $(2.9) million, or $(0.04) per share, for the comparable period in 2022.

For the six months ended June 30, 2023 and 2022, revenues were approximately $5.5 million and $4.3 million, respectively. Gross profit for the first six months of 2023 was $3.8 million, or 69% of revenue, versus $2.4 million, or 54% of revenue, for the first six months of 2022. Operating loss for the first six months of 2023 was approximately $(3.6) million versus approximately $(4.8) million for the first six months of 2022. Net loss for the first six months of 2022 was $(3.5) million, or $(0.05) per share, versus net loss of $(4.8) million, or $(0.07) per share, for the comparable period in 2022.

As of June 30, 2023, the Company had cash, cash equivalents and short-term securities of approximately $5.7 million and working capital of approximately $7.4 million.

Conference Call

Milestone Scientific’s executive management team will host a conference call today, Tuesday, August 15, 2023, at 8:30 AM Eastern Time to discuss the Company’s financial results for the second quarter ended June 30, 2023, 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: 612343. A webcast and replay of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2306/48912.

An audio replay of the call will be available through August 29, 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: 48912.

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, 2022. 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:Crescendo Communications, LLCEmail: mlss@crescendo-ir.comTel: 212-671-1020

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MILESTONE SCIENTIFIC AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
 
    June 30, 2023     December 31, 2022  
      (Unaudited)          
ASSETS                
Current assets:                
Cash and cash equivalents   $ 3,701,453     $ 8,715,279  
Marketable securities     1,981,180       -  
Accounts receivable, net     789,584       693,717  
Prepaid expenses and other current assets     551,990       443,872  
Inventories     2,193,063       1,792,335  
Advances on contracts     1,282,806       1,325,301  
Total current assets     10,500,076       12,970,504  
Furniture, fixtures and equipment, net     11,867       18,146  
Intangibles, net     201,529       227,956  
Right of use assets finance lease     13,319       17,645  
Right of use assets operating lease     400,511       443,685  
Other assets     24,150       24,150  
Total assets   $ 11,151,452     $ 13,702,086  
                 
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable   $ 674,587     $ 1,102,729  
Accounts payable, related party     626,690       803,492  
Accrued expenses and other payables     1,422,506       1,124,839  
Accrued expenses, related party     278,339       167,549  
Current portion of finance lease liabilities     9,805       9,365  
Current portion of operating lease liabilities     97,429       91,701  
Total current liabilities     3,109,356       3,299,675  
Non-current portion of finance lease liabilities     5,683       10,698  
Non-current portion of operating lease liabilities     334,750       385,279  
Total liabilities   $ 3,449,789     $ 3,695,652  
                 
Commitments                
                 
Stockholders’ equity                
Common stock, par value $.001;authorized 100,000,000 shares; 70,107,739 shares issued and 70,074,406 shares outstanding as of June 30, 2023; 69,306,497 shares issued and 69,273,164 shares outstanding as of December 31, 2022;     70,108       69,306  
Additional paid in capital     128,720,911       127,478,325  
Accumulated deficit     (119,934,388 )     (116,410,405 )
Treasury stock, at cost, 33,333 shares     (911,516 )     (911,516 )
Total Milestone Scientific, Inc. stockholders' equity     7,945,115       10,225,710  
Noncontrolling interest     (243,452 )     (219,276 )
Total stockholders’ equity     7,701,663       10,006,434  
                 
Total liabilities and stockholders’ equity   $ 11,151,452     $ 13,702,086  
 

MILESTONE SCIENTIFIC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
                                 
    For the three months ended June 30, 2023     For the three months ended June 30, 2022     For the six months ended June 30, 2023     For the six months ended June 30, 2022  
                                 
Product sales, net   $ 2,909,966     $ 1,648,368     $ 5,507,564     $ 4,349,270  
Cost of products sold     1,019,907       967,720       1,728,882       1,986,196  
Gross profit     1,890,059       680,648       3,778,682       2,363,074  
                                 
Selling, general and administrative expenses     3,937,281       3,282,322       7,011,012       6,397,948  
Research and development expenses     213,647       266,560       353,994       731,027  
Depreciation and amortization expense     16,681       16,645       33,902       33,460  
Total operating expenses     4,167,609       3,565,527       7,398,908       7,162,435  
                                 
Loss from operations     (2,277,550 )     (2,884,879 )     (3,620,226 )     (4,799,361 )
Interest income (expense)     48,722       3,550       72,067       (1,193 )
Loss before provision for income taxes     (2,228,828 )     (2,881,329 )     (3,548,159 )     (4,800,554 )
Net loss     (2,228,828 )     (2,881,329 )     (3,548,159 )     (4,800,554 )
Net loss attributable to noncontrolling interests     (12,511 )     (22,848 )     (24,176 )     (40,350 )
Net loss attributable to Milestone Scientific Inc.   $ (2,216,317 )   $ (2,858,481 )   $ (3,523,983 )   $ (4,760,204 )
                                 
Net loss per share applicable to common stockholders—                                
Basic and Diluted     (0.03 )     (0.04 )     (0.05 )     (0.07 )
                                 
Weighted average shares outstanding and to be issued—                                
Basic and Diluted     72,333,656       70,356,796       72,048,223       70,585,590  

 

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