GlobeNewswire Inc | Nov 17, 2020 08:00AM EST

November 17, 2020

ROSELAND, N.J., Nov. 17, 2020 (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 third quarter and nine months ending September 30, 2020.

Leonard Osser, Interim Chief Executive Officer of Milestone Scientific, commented, "This quarter, our dental business improved considerably as dental offices began to reopen across the country and around the world. Specifically, our dental sales increased more than seven-fold versus the second quarter of 2020. Importantly, our marketing initiatives and back to work' promotions have been well received, as we are working hard to address the needs of both dentists and their patients during the pandemic.

"With a number of hospitals re-opening to outside vendors, we are advancing our sales efforts and exploring new collaboration opportunities around the CompuFlo Epidural System and CathCheck. Most recently, we were awarded a group purchasing agreement with Premier, a leading group purchasing organization, with approximately 4,100 U.S. hospitals and 200,000 other providers within their network. This agreement is further validation of the growing awareness and importance of our instruments in improving health outcomes and lowering costs for healthcare institutions. At the same time, we are expanding our trials in major hospitals and medical schools, as well as partnering with key opinion leaders to approach the purchasing departments of hospitals together. We look forward to announcing additional agreements with several premier hospitals as soon as they are completed. Finally, we have a strong cash runway with over $14 million of cash on hand as of September 30, 2020. This liquidity, combined with our improved cash flow, will support our ongoing activities, including accelerated marketing activities around both our dental and medical instruments.

For the three months ended September 30, 2020 and 2019, revenues were approximately $1.2 million and $1.9 million, respectively. Dental revenues decreased by approximately $644,000, due to the impact of the COVID-19 pandemic on the Companys customers, suppliers, vendors, and other business partners. Gross profit for the third quarter ended September 30, 2020 was approximately $836,000, or 67% of revenue, versus approximately $1.4 million, or 72% of revenue for the third quarter ended September 30, 2019. Operating loss for the three months ended September 30, 2020 was approximately $(1.5) million versus $(1.0) million for the three months ending September 30, 2019. The increase in operating loss is due to decreased dental revenue. Net loss for the three months ended September 30, 2020 was approximately $(1.5) million, or $(0.02) per share, versus a net loss $(2.8) million, or $(0.06) per share, in the prior period.

For the nine months ended September 30, 2020 and 2019, revenues were approximately $3.2 million and $6.1 million, respectively. Dental revenues decreased by approximately $2.8 million, which is related to decrease in sales of handpieces and devices throughout the country and internationally due to the COVID-19 pandemic. Gross profit for the nine months of 2020 was $2.2 million or 68% of revenue versus $4.2 million or 69% of revenue for the first nine months of 2019. Operating loss for the nine months of 2020 was approximately $(6.3) million versus approximately $(2.9) million for the nine months of 2019. Net loss for the nine months of 2020 was $(6.3) million, or $(0.11) per share, versus net loss of $(4.7) million, or $(0.11) per share, for the comparable period in 2019.

Conference Call

Milestone Scientifics executive management team will host a conference call at 8:30 AM Eastern Time Tuesday, November 17, 2020 to discuss the Companys financial results for the third quarter ended September 30, 2020, as well as the Companys corporate progress and other developments.

The conference call will be available on the Companys website at www.milestonescientific.com, or via telephone by dialing toll free 877-407-0778 for U.S. callers, or +1 201-689-8565 for international callers. For those unable to participate at that time, a replay of the call will be archived on the companys website or can be accessed by dialing 877-481-4010 for U.S. callers, or +1 919-882-2331 for international callers and entering the pass code 38544. The replay will be available for 90 days.

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, 2018. 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.



MILESTONE SCIENTIFIC AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(UNAUDITED) September 30, December 31, 2019 2020 ASSETS Current assets: Cash and cash equivalents $ 14,448,903 $ 1,516,272 Accounts receivable, net 962,983 1,710,665 Prepaid expenses and other current 527,059 519,063 assetsInventories, net 2,229,760 1,620,509 Advances on contracts 723,084 710,662 Total current assets 18,891,789 6,077,171 Furniture, fixtures and equipment, 31,311 44,976 netPatents, net 342,501 382,260 Right of use assets 655,870 15,977 Other assets 24,150 35,905 Total assets $ 19,945,621 $ 6,556,289 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 666,094 1,379,425 Accounts payable, related party 393,090 1,358,752 Accrued expenses and other payables 1,147,698 775,055 Accrued expenses, related party 593,625 1,057,958 Current portion of finance leases 7,903 3,904 Current operating lease right-of-use 68,934 12,072 liabilitiesNote payable 276,180 - Deferred profit, related party 340,476 340,476 Total current liabilities 3,494,000 4,927,642 Finance lease liabilities, 30,624 - non-currentOperating lease right-of-use 576,407 - liabilitiesTotal liabilities $ 4,101,031 $ 4,927,642 Commitments and contingencies Stockholders' equity Common stock, par value $.001;authorized 75,000,000 shares;63,605,119shares issued and 63,571,786 sharesoutstanding as of September 30, 2020; 63,605 49,410 49,410,176 shares issued and49,376,843 shares outstanding as ofDecember31, 2019;Additional paid in capital 116,577,241 96,082,324 Accumulated deficit (99,806,352 ) (93,524,297 )Treasury stock, at cost, 33,333 (911,516 ) (911,516 )sharesTotal Milestone Scientific Inc. 15,922,978 1,695,921 stockholders' equityNoncontrolling interest (78,388 ) (67,274 )Total stockholders' equity 15,844,590 1,628,647 Total liabilities and stockholders' $ 19,945,621 $ 6,556,289 equity

MILESTONE SCIENTIFIC AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(UNAUDITED) Three months Three months Nine months Nine months ended ended ended ended September 30, September 30, September 30, September 30, 2020 2019 2020 2019Product sales, $ 1,246,110 $ 1,899,821 $ 3,225,170 $ 6,073,580 netCost of 409,621 523,672 1,024,947 1,894,550 products soldGross profit 836,489 1,376,149 2,200,223 4,179,030 Selling,general and 2,291,779 2,314,943 8,221,359 6,941,964 administrativeexpensesResearch anddevelopment 21,438 7,940 237,089 109,815 expensesTotaloperating 2,313,217 2,322,883 8,458,448 7,051,779 expenses Loss from (1,476,728 ) (946,734 ) (6,258,225 ) (2,872,749 )operationsInterest (569 ) (2,449 ) (8,727 ) (6,067 )expenseChange in fairvalue of - (1,899,484 ) - (1,846,761 )derivativeliabilityLoss beforeprovision forincome taxes (1,477,297 ) (2,848,667 ) (6,266,952 ) (4,725,577 )and net ofequityinvestmentsProvision for (24,717 ) (1,250 ) (26,217 ) (19,877 )income taxesLoss beforeequity in netearnings (1,502,014 ) (2,849,917 ) (6,293,169 ) (4,745,454 )(losses) ofequityinvestmentsEarnings fromChina Joint - - - 49,099 VentureNet loss (1,502,014 ) (2,849,917 ) (6,293,169 ) (4,696,355 )Net lossattributableto 11,025 12,941 35,501 35,343 noncontrollinginterestsNet lossattributableto Milestone $ (1,490,989 ) $ (2,836,976 ) $ (6,257,668 ) $ (4,661,012 )ScientificInc. Net loss pershareapplicable to commonstockholders--Basic (0.02 ) (0.06 ) (0.11 ) (0.11 )Diluted (0.02 ) (0.06 ) (0.11 ) (0.11 ) Weightedaverage sharesoutstanding and to beissued--Basic 65,817,132 47,721,732 56,478,151 43,311,984 Diluted 65,817,132 47,721,732 56,478,151 43,311,984

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