GlobeNewswire Inc | Apr 1, 2021 07:30AM EDT

April 01, 2021

ROSELAND, N.J., April 01, 2021 (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, 2020.

Arjan Haverhals, President of Milestone Scientific and CEO of Wand Dental Inc., stated, "I am pleased to report that our revenue for the fourth quarter of 2020 increased sequentially by approximately $1 million, or 78% versus the third quarter of 2020. Importantly, we carefully managed our operating expenses during the year and reduced our net loss. We achieved these strong results despite the impact of COVID-19, which shows that we are successfully navigating the pandemic and are on a growth trajectory. Our sales initiatives are working. We expanded our dental distribution network to seven independent distributors in the U.S., plus a new distributor in Canada. Through our new decentralized sales strategy, we accomplished our goal of building a robust distribution network in the U.S. We are encouraged by the growing interest in our dental instrument, and we expect our growth within the dental business to continue in 2021.

At the same time, we have made significant progress over the past year advancing our commercial efforts around the CompuFlo Epidural Instrument and CathCheck System. Specifically, we have added new distributors and begun to penetrate key hospitals with our CompuFlo Epidural Instrument and we expect this trend to continue as we anticipate adding additional hospitals in 2021. A key element of our sales strategy focuses on the disposable components of our system, which we believe will contribute to high margins and recurring revenue. Were also expanding our medical sales force, and now that new protocols are in place at hospitals, we are better able to enter the hospitals and have commenced a number of new pilot programs. Overall, the response from both hospitals and physicians has been positive and we are in a number of trials across the country that have the potential to convert to additional commercial orders this year.

Leonard Osser, Interim Chief Executive Officer, further noted, We have a strong cash runway with over $14 million of cash, cash equivalents and other short-term investments as of December 31, 2020. In addition, the proceeds from the recent exercise of warrants strengthens our balance sheet with an additional $4 million of cash since November 2020. This liquidity, combined with our improved cash flow, should help accelerate our sales and marketing activities around both our dental and medical instruments. We believe the strength of our balance sheet provides us substantial runway to advance the development and commercialization of other indications for our proprietary DPS Dynamic Pressure Sensing Technology. We believe this technology platform is quite broad with multiple indications in large and underserved markets.

For the years ended December 31, 2020 and 2019, revenues were approximately $5.4 million and $8.3 million, respectively. Dental revenues decreased by approximately $2.9 million, due to the impact of the COVID-19 pandemic on the Companys customers and other business partners. Gross profit for the year ended December 31, 2020 was $3.6 million or 67% of revenue versus $5.7 million or 68% of revenue for the year ended December 31, 2019. Operating loss for the year ended December 31, 2020 was approximately $(7.5) million versus approximately $(4.0) million for the year ended December 31, 2019. Net loss was approximately $(7.3) million, or $(0.12) per share for the year ended December 31, 2020, versus net loss of $(7.5) million, or $(0.16) per share, for the comparable period in 2019.

Conference Call

Milestone Scientifics executive management team will host a conference call at 4:30 PM Eastern Time on Thursday, April 1, 2021 to discuss the Companys financial results for the full year ending December 31, 2020, as well as the Companys corporate progress and other developments.

The conference call will be available via telephone by dialing toll free 1- 877-407-0778 for U.S. callers or 201-689-8565 for international callers. A webcast of the call may be accessed here or on the Companys website at https://www.milestonescientific.com/.

An audio replay of the of the call will be available through April 15, 2021 and can be accessed by dialing 877-481-4010 for U.S callers or 919-882-2331 for international callers and by entering the access code: 40609.

About Milestone Scientific Inc.

Milestone Scientific Inc. (MLSS) is a biomedical technology research and development company that patents, designs and develops innovative diagnostic and therapeutic injection technologies and instruments for medical, dental, cosmetic and veterinary applications. Milestone's computer-controlled systems are designed to make injections precise, efficient, and virtually painless. Milestones proprietary DPS Dynamic Pressure Sensing technology is our technology platform that advances the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions for local anesthesia for subcutaneous drug delivery, with specific applications for cosmetic botulinum toxin injections, epidural space identification in regional anesthesia procedures and intra-articular joint injections. For more information please visit our website: www.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, 2020. 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 SUBSIDIARIESCONSOLIDATED BALANCE SHEETS

December 31, December 31, 2020 2019ASSETS Current assets: Cash and cash equivalents $ 14,223,917 $ 1,516,272 Accounts receivable, net 1,080,656 1,710,665 Prepaid expenses and other current assets 415,915 519,063 Inventories, net 2,420,179 1,620,509 Advances on contracts 414,202 710,662 Total current assets 18,554,869 6,077,171 Furniture, fixtures and equipment, net 30,729 44,976 Intangibles, net 329,249 382,260 Right of use assets 632,453 15,977 Other assets 24,150 35,905 Total assets $ 19,571,450 $ 6,556,289 LIABILITIES AND STOCKHOLDERS? EQUITY Current liabilities: Accounts payable $ 482,972 $ 1,379,425 Accounts payable, related party 385,138 1,358,752 Accrued expenses and other payables 824,454 775,055 Accrued expenses, related party 586,734 1,057,957 Current portion of finance leases 7,796 3,904 liabilitiesCurrent portion of operating lease 72,031 12,073 right-of-use liabilitiesDeferred profit, related party 242,589 340,476 Note payable 276,180 - Total current liabilities 2,877,894 4,927,642 Finance lease liabilities 28,607 - Operating lease liabilities 557,981 - Total liabilities $ 3,464,482 $ 4,927,642 Commitments and contingencies Stockholders? equity Common stock, par value $.001; authorized85,000,000 shares; 64,171,435 sharesissued and 64,138,102 shares outstanding 64,171 49,410 as of December 31, 2020; 49,410,176 sharesissued and 49,376,843 shares outstandingas of December 31, 2019;Additional paid in capital 117,934,696 96,082,324 Accumulated deficit (100,885,957 ) (93,524,297 )Treasury stock, at cost, 33,333 shares (911,516 ) (911,516 )Total Milestone Scientific Inc. 16,201,394 1,695,921 stockholders' equityNoncontrolling interest (94,426 ) (67,274 )Total stockholders? equity $ 16,106,968 $ 1,628,647 Total liabilities and stockholders? equity $ 19,571,450 $ 6,556,289

MILESTONE SCIENTIFIC AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONSYEARS ENDED DECEMBER 31, 2020AND 2019

2020 2019 Product sales, net $ 5,437,236 $ 8,374,501 Cost of products sold 1,815,924 2,656,142 Gross profit 3,621,312 5,718,359 Selling, general and administrative expenses 10,766,580 9,527,429 Research and development expenses 307,850 189,923 Total operating expenses 11,074,430 9,717,352 Loss from operations (7,453,118 ) (3,998,993 ) Other expenses (24,790 ) (10,408 )Interest income 6,709 1,543 Change in fair value of derivative liability - (3,635,580 )Loss before provision for income taxes and (7,471,199 ) (7,643,438 )net of equity investmentsProvision for income taxes (15,500 ) (18,126 )Loss before equity in net earnings of equity (7,486,699 ) (7,661,564 )investmentsEarnings from equity method investment 97,887 81,324 Net loss (7,388,812 ) (7,580,240 )Net loss attributable to noncontrolling 51,539 55,872 interestsNet loss attributable to Milestone Scientific (7,337,273 ) (7,524,368 )Inc. Net loss per share applicable to common stockholders?Basic $ (0.12 ) $ (0.16 )Diluted $ (0.12 ) $ (0.16 ) Weighted average shares outstanding and to be issued?Basic 63,061,358 45,740,050 Diluted 63,061,358 45,740,050

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