MILESTONE SCIENTIFIC INC. The following discussions of the financial condition and results of operations should be read in conjunction with the financial statements and the notes to those statements contained in this report and in connection with management's discussion and analysis and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year endedDecember 31, 2019 , which was filed with theSecurities and Exchange Commission , orSEC onMarch 30, 2020 . Certain statements in this discussion and elsewhere in this report constitute forward-looking statements, within the meaning of section 21E of the Exchange Act, that involve risks and uncertainties. The actual results may differ materially from those anticipated in these forward-looking statements. OVERVIEW Our common stock was listed on the NYSE American onJune 1, 2015 and trades under the symbol "MLSS". We have developed a proprietary, computer-controlled anesthetic delivery instrument, using The Wand, a single use disposable handpiece. The instrument is marketed in dental sector under the trademark CompuDent®, and STA Single Tooth Anesthesia System and in medical sector under the trademark CompuMed. CompuDent is suitable for all dental procedures that require local anesthetic. CompuMed is suitable for many medical procedures regularly performed in plastic surgery, hair restoration surgery, podiatry, colorectal surgery, dermatology, orthopedics, and several other disciplines. The dental instruments are sold inthe United States ,U.S. territories,Canada , and in over 58 other countries abroad. InJune 2017 , the FDA approved our 510(k) applications for marketing clearance inthe United States of our CompuFlo Epidural Computer Controlled Anesthesia System. We are in the process of meeting with medical facilities and device distributors withinthe United States andEurope . There have been five medical instruments sold inthe United States in 2018 and limited amounts sold internationally as of the reporting date. Certain of our medical instruments have obtained European CE mark approval and can be marketed and sold in most European countries.
? Establishing Milestone's DPS Dynamic Pressure Sensing technology
platform as the standard-of-care in painless and precise drug delivery,
providing for the first time, objective visual and audible in-tissue
pressure feedback, and continuing to expand platform applications;
? Following obtaining successful FDA clearance of our first medical
devices, Milestone Scientific is transitioning from a research and
development organization to a commercially focused medical device
company;? Expanding our global footprint of our CompuFlo Epidural and CathCheck
System by utilizing a Direct Field Sales Force and partnering with
distribution companies worldwide; and
? Continuing the development of our proprietary cosmetic injection device
for delivery of botulinum toxin (such as Botox® and Dysport®)
Wand/STA Dental Market
Since its market introduction in early 2007, the Wand/STA Instrument and prior
C-CLAD devices have been used to deliver over 80 million safe, effective, and
comfortable injections. The instrument has also been favorably evaluated in
numerous peer-reviewed, published clinical studies and associated articles.
Moreover, there appears to be a growing consensus among users that the STA
Instrument is proving to be a valuable and beneficial instrument that is
positively impacting the practice of dentistry worldwide.
Beginning January 1, 2016 , Milestone Scientific entered into a non-exclusive
distribution agreement with Henry Schein, Inc. ("Henry Schein"). In June 2016 ,
that agreement was replaced with an exclusive distribution arrangement for our
dental products for the United States and Canada with Henry Schein. Under this
arrangement we have a semi-dedicated independent sales force visiting dentists.
The Company's exclusive agreement is subject to annual purchase requirements and
other requirements, as defined in the agreement.`
To date, Henry Schein has endeavored to accomplish the goals set forth in the
exclusive distribution agreement for The Wand STA instrument and handpieces,
including training of its exclusive products sale's specialists. Specifically,
up to 25 exclusive product sales specialists have now been fully trained as
experts in the features, advantages and benefits of The Wand/STA instrument and
handpieces and all are currently in the field selling the instrument.
Henry Schein increased the number of exclusive product specialist in 2019 and
trained an additional customer service representative to support dentists across
North America through its exclusive product sales customer call center. During
the Covid-19 Pandemic, Henry Schein has lost one of its exclusive product
specialist. Henry Schein is in the process of recruiting additional specialist
in the fourth quarter of 2020.
26
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On the global front, we have granted exclusive marketing and distribution rights
for the Wand/STA Instrument to select dental suppliers in various international
regions in Asia , Africa , South America , and Europe . They include FM Produkty Dla
Stomatologii in Poland and Unident AB in the Scandinavian countries of Denmark ,
Sweden , Norway , and Iceland .
In October 2012 , the State Food and Drug Administration (CFDA) of the People's
Republic of China approved our Wand/STA Single Tooth Anesthesia System (STA
System). In May 2014 , the CFDA also approved the Wand STA handpieces for sale in
China .
Medical Market
During 2016, Milestone Scientific filed for 510(k) marketing clearance with the
U.S. Food and Drug Administration (FDA) for both intra-articular and epidural
injections with the CompuFlo Epidural System. In June 2017 , the FDA approved
the CompuFlo Epidural System for epidural injections. Milestone Scientific is in
the process of meeting with medical device distributors within the United States
and foreign markets. Milestone Scientific's immediate focus is on marketing its
epidural device throughout the United States and Europe .
In December 2016 , we received notification from the FDA that based upon the
510(k)-application submitted for intra- articular injections, we did not
adequately document that the device met the equivalency standard required for
510(k) clearances. Following consultation with the FDA Office of Device
Evaluation , we filed a new 510(k) application for the device in June 2018 . In
August 2018 , the FDA provided Milestone Scientific with a list of questions on
the intra-articular 510(k) application filed in June 2018 . Due to the delay in
responding to the FDA questions Milestone Scientific will be required file a new
510(K) application.
In January 2019 , the Company announced the results of a four hundred patient
clinical trial by researchers from the University of Miami , University of Texas ,
and Northwestern University , and two prominent California -based pain clinics.
Published-Ahead-of-Print in Anesthesia & Analgesia (the official Journal of the
International Anesthesia Research Society ), the randomized, controlled study
compared the effectiveness of the CompuFlo Epidural System in labor and delivery
and chronic pain management, where loss of resistance and fluoroscopy are the
current standards of care. The CompuFlo Epidural System was found to be
ninety-nine percent successful in objectively identifying the epidural space
even in challenging patients with a higher body mass index.
In February 2019 , the Company announced a new 120-patient clinical study
published in Anesthesiology Research & Practice that verifies the CompuFlo
Epidural System consistently differentiates false loss of resistance from true
loss of resistance during epidural placement. In all cases where the CompuFlo
Epidural System's pressure measurements were used to objectively identify the
epidural space, the block was performed successfully with no complications.
In February 2019 , the Company announced Ospedale "Pugliese Ciaccio" di Catanzaro
is the first hospital in Italy to use the CompuFlo Epidural System for all
epidurals in labor and delivery. For a local hospital performing a limited
number of epidurals, the CompuFlo Epidural System offers a real-time, objective
tool for accurate epidural space identification to help reduce failure rates and
accidental dural punctures that can require further treatment and interventions.
In April, 2019 the Company entered the medical education market with the
introduction of the CompuFlo® Epidural Trainer (CompuFlo Trainer), an
instructional instrument that uses pressure sensing technology to improve
epidural placement success. The Company has signed an agreement to distribute
the CompuFlo Trainer with American 3B Scientific , a leading supplier of didactic
material for medical education.
In June 2019 the Company announced the results of two research abstracts
featuring the CompuFlo Epidural device at Euroanesthesia 2019, Europe's largest
annual event showcasing the latest knowledge in the field of anesthesia. The
abstracts were presented during scientific poster sessions highlighting how
CompuFlo's objective detection of tissue pressure makes challenging procedures
with difficult patients more efficient and accelerates clinical competency for
trainee.
In October 2019 , the Company announced the first international multicenter study
to compare the incidence of accidental dural puncture using the CompuFlo
Epidural System versus the continuous loss of resistance (LOR) technique. The
study collected records between 2015 and 2019 of epidural administration on
labor and delivery patients using the CompuFlo Epidural System from four
institutions, one in the U.S. , one in Chile , and two from Italy . Among the four
sites, there were 812 patients who received epidural analgesia with CompuFlo,
and none had accidental dural puncture regardless of the composition of the
epidural performer types.
27-------------------------------------------------------------------------------- The Company also announced that Professor Rovnat Babazade, MD,University of Texas Medical Branch at Galveston ,Department of Anesthesiology , presented a poster at the ANESTHESIOLOGY® 2019 Annual Meeting inOrlando, Florida , entitled, "International Multicenter Study of Accidental Dural Puncture Rate; Comparison of the CompuFlo with Traditional Method''. ANESTHESIOLOGY 2019, hosted by theAmerican Society of Anesthesiologists (ASA), unites more than 14,000 clinicians, thought leaders and professionals from around the world. InNovember 2019 , the Company and3B Scientific , the world's leading supplier of didactic material for medical education, signed a global agreement expanding distribution of the CompuFlo Trainer. The expanded agreement allows3B Scientific to capitalize on momentum from strong interest in the CompuFlo Trainer at its unveiling at Euroanesthesia 2019 and theAssociation of Women's Health , Obstetric and Neonatal Nurses meeting, and gives more anesthesia instructors the ultimate solution to accelerate the epidural procedure's learning curve and trainee success. OnApril 21, 2020 ,Milestone Scientific , announced that it has validated and integrated the new CathCheck™ feature into the CompuFlo® Epidural System. Using CathCheck™, physicians and nurses can monitor the placement of a catheter to determine the presence or absence of a pulsatile waveform (heartbeat) providing new information that can be used to determine if the catheter is in place or has become dislodged from the epidural space. This can be performed within seconds by measuring the pulsatile waveform within the epidural space. OnOctober 13, 2020 ,Milestone Scientific announced a Group Purchasing Agreement with Premier a leading healthcare improvement company, utilizing an alliance of approximately 4,100U.S. hospitals and 200,000 other providers to transform healthcare. The Agreement, which became effectiveNovember 1, 2020 , allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for the CompuFlo® Epidural System and CathCheck™. This agreement expires onFebruary 28, 2022 . Covid-19 Pandemic While the COVID-19 pandemic did not materially adversely affect the Company's financial results and business operations in the Company's first fiscal quarter endedMarch 31, 2020 , economic and health conditions inthe United States and across most of the globe have changed rapidly since the end of the first quarter. In the short-term, demand for the Company's products decreased, notably in our dental and medical divisions. Such decrease demand may or may not continue and/or demand may or may not increase from historical levels depending on the duration and severity of the COVID-19 pandemic, the length of time it takes for normal economic and operating conditions to resume, additional governmental actions that may be taken and/or extensions of time for restrictions that have been imposed to date, and numerous other uncertainties. Such events may result in business and manufacturing disruption, inventory shortages, delivery delays, and reduced sales and operations, any of which could materially affect our business, financial condition, and results of operations. The Company's employees are being affected by the COVID-19 pandemic. The majority of our office and management personnel are working remotely. The health of the Company's workforce is of primary concern and the Company may need to enact further precautionary measures to help minimize the risk of our employees being exposed to the coronavirus. Further, our management team is focused on mitigating the adverse effects of the COVID-19 pandemic, which has required and will continue to require a large investment of time and resources across the entire Company, thereby diverting their attention from other priorities that existed prior to the outbreak of the pandemic. If these conditions worsen, or last for an extended period of time, the Company's ability to manage its business may be impaired, and operational risks, cybersecurity risks and other risks facing the Company prior to the pandemic may be elevated.
The COVID-19 pandemic is affecting the Company's customers, suppliers, vendors, and other business partners, but the Company is not able to predict the ultimate consequences that will result therefrom.
The COVID-19 pandemic did affect the Company's operations in the second and
third quarters and may continue to do so indefinitely thereafter. All of these
factors may have far reaching impacts on the Company's business, operations, and
financial results and conditions, directly and indirectly, including without
limitation impacts on the health of the Company's management and employees,
manufacturing, distribution, marketing and sales operations, customer and
consumer behaviors, and on the overall economy. The scope and nature of these
impacts, most of which are beyond the Company's control, continue to evolve and
the outcomes are uncertain.
28-------------------------------------------------------------------------------- Due to the above circumstances and as described generally in this Form 10-Q, the Company's results of operations for the three- and nine month period endedSeptember 30, 2020 are not necessarily indicative of the results to be expected for the full fiscal year. The following table shows a breakdown ofMilestone Scientific's product sales (net), domestically and internationally, by business segment product category: Three months ended September 30, Nine months ended September 30 2020 2019 2020 2019 Domestic-US Devices $ 34,657 $ 199,926 $ 35,181$ 409,529 Handpieces 356,566 679,621 994,057 2,250,842 Other 16,906 17,343 37,895 61,408 Total Domestic US $ 408,129 $ 896,890$ 1,067,133 $ 2,721,779 International ROW Devices $ 220,694 $ 412,819$ 502,598 $ 1,108,488 Handpieces 608,000 579,765 1,624,724 2,040,250 Other 9,287 10,347 30,715 103,063 Total International-ROW $ 837,981 $
1,002,931$ 2,158,037 $ 3,251,801 International-China Devices $ - $ - $ - $ - Handpieces - - - 100,000 Other - - - -Total International $ - $ - $ -$ 100,000 Total Product Sales$ 1,246,110 $ 1,899,821 $ 3,225,170 $ 6,073,580 Current Product Platform
See Note 1 Organization and Business.
Results of Operations
The following table sets forth the consolidated results of operations for the
three months ended
Three months ended September 30,
2020 2019
Operating results:
Product sales, net $ 1,246,110 $ 1,899,821
Cost of products sold 409,621 523,672
Gross profit 836,489 1,376,149
Operating expenses:
Selling, general and administrative expenses 2,291,779 2,314,943
Research and development expenses 21,438 7,940 Loss from operations (1,476,728 ) (946,734 ) Other income, and loss on earning net (25,286 ) (1,903,183 ) Net loss (1,502,014 ) (2,849,917 ) Net loss attributable to noncontrolling interests 11,025 12,941
Net loss attributable to
29
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The following table sets forth the consolidated results of operations for the
nine months ended
Nine months ended September 30,
2020 2019
Operating results:
Product sales, net $ 3,225,170 $ 6,073,580
Cost of products sold 1,024,947 1,894,550
Gross profit 2,200,223 4,179,030
Operating expenses:
Selling, general and administrative expenses 8,221,359 6,941,964
Research and development expenses 237,089 109,815 Loss from operations (6,258,225 ) (2,872,749 ) Other income, and loss on earning net (34,944 ) (1,823,606 ) Net loss (6,293,169 ) (4,696,355 ) Net loss attributable to noncontrolling interests 35,501 35,343 Net loss attributable to Milestone Scientific Inc.$ (6,257,668 ) $ (4,661,012 ) September 30, September 30, Cash flow: 2020 2019 Net cash used in operating activities$ (6,346,160 ) $ (1,275,686 ) Net cash used in investing activities$ (21,438 ) $ (9,916 ) Net cash provided by financing activities$ 19,300,229 $ 2,253,422
Three months ended
Net sales for 2020 and 2019 were as follows:
2020 2019 Increase Decrease %
Dental $ 1,240,110 $ 1,884,321 $ (644,211 ) -34.19 %
Medical 6,000 15,500 (9,500 ) -61.29 %
Total sales, net $ 1,246,110 $ 1,899,821 $ (653,711 ) -34.41 %
Consolidated revenue for the three months ended, September 30, 2020 and 2019
were approximately $1.2 million and $1.9 million , respectively. Dental revenue
for the three months ended September 30, 2020 and 2019 were approximately $1.2
and $1.9 million , respectively. Dental revenues decreased by approximately
$644,000 which is related to COVID-19 pandemic affecting the Company's
customers, suppliers, vendors, and other business partners. In the short-term,
demand for the Company's products decreased, notably in our dental divisions.
Such decreased demand may or may not continue and/or demand may or may not
increase from historical levels depending on the duration and severity of the
COVID-19 pandemic, the length of time it takes for normal economic and operating
conditions to resume, additional governmental actions that may be taken and/or
extensions of time for restrictions that have been imposed to date, and numerous
other uncertainties.
As a result of the reduced hours and closings of dental offices throughout the
country and the rest of the world due to the continuing spread of COVID-19, our
revenue for the third quarter was materially and adversely affected. At this
point in time, it is too early to determine an estimate of what the fourth
quarter impact will be, or the effect COVID-19 may have on our fourth quarter
revenue. In addition, it is too early to determine what the effect will be on
the anticipated commercialization of our CompuFlo Epidural system as a medical
device for the remainder of 2020, and the first quarter of 2021.
30
--------------------------------------------------------------------------------Gross Profit for 2020 and 2019 were as follows:
2020 2019 Increase Decrease %
Dental $ 833,254 $ 1,372,758 $ (539,504 ) -39.30 %
Medical 3,235 3,391 (156 ) -4.60 %
Total gross profit $ 836,489 $ 1,376,149 $ (539,660 ) -39.22 %
Consolidated gross profit for the three months ended
Selling, general and administrative expenses for 2020 and 2019 were as follows:
Increase
2020 2019 Decrease %
Dental $ 643,794 $ 728,108 $ (84,314 ) -11.58 %
Medical 792,866 550,294 242,572 44.08 %
Corporate 855,119 1,036,541 (181,422 ) -17.50 %
Total selling, general and
administrative expenses $ 2,291,779 $ 2,314,943 $ (23,164 ) -1.00 %
Consolidated selling, general and administrative expenses for the three months
ended September 30, 2020 and 2019, were approximately $2.2 million and
$2.3 million , respectively. The decrease of approximately $16,000 is categorized
in several areas. Employee salaries, and benefits expenses increased
approximately $154,000 during the three months ended September 30, 2020 , as the
Company hired additional employees to work on the commercialization of
the CompuFlo® Epidural System. During the three months ended September 30, 2020
D&O insurance increased approximately $54,000 due to the increase of premiums.
Due to Covid-19 Pandemic, the Company's travel expenses, trade shows,
professional fees, quality control, and general expenses decreased
approximately $275,000 while marketing and consulting expense increased
approximately $43,000 for three months ended September 30 ,2020.
Research and Development for 2020 and 2019 were as follows:
2020 2019 Increase Decrease %
Dental $ - $ - $ - 0.00 %
Medical 21,438 7,940 13,498 170.00 %
Corporate - - - 0.00 %
Total research and development $ 21,438 $ 7,940 $ 13,498 170.00 %
Consolidated research and development expenses for the three months ended, 2020
and 2019, were approximately $21,000 and $7,900 , respectively. The increase is
associated with the Company developing software upgrades and enhancement for the
CompuFlo® Epidural System and handpieces.
Profit (Loss) from Operations for 2020 and 2019 were as follows:
Increase
2020 2019 Decrease %
Dental
Medical $ 191,235 $ 644,650 $ (453,415 ) -70.34 %
Corporate (812,840 ) (554,843 ) (257,997 ) 46.50 %
Total loss from operations (855,123 ) (1,036,541 ) 181,418 -17.50 %
$ (1,476,728 ) $ (946,734 ) $ (529,994 ) 55.98 %
The loss from operations was approximately $1.5 million and $1 million for the
three months ending September 30, 2020 and 2019, respectively. The increase is
the result of decreased dental revenue, due to reduced hours and closings of
dental and medical offices throughout the country and the rest of the world due
to the continuing spread of COVID-19. We anticipate that our revenue for the
fourth quarter, and possibly the first quarter of 2021, will be materially and
adversely affected.
31
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Nine months ended
Net sales for 2020 and 2019 were as follows:
2020 2019 Increase Decrease %
Dental $ 3,209,370 $ 6,042,580 $ (2,833,210 ) -46.89 %
Medical 15,800 31,000 (15,200 ) -49.03 %
Total sales, net $ 3,225,170 $ 6,073,580 $ (2,848,410 ) -46.90 %
Consolidated revenue for the nine months ended September 30, 2020 and 2019 were
approximately $3.2 million and $6.1 million , respectively. Dental revenue for
the nine months ended September 30, 2020 and 2019 were approximately
$3.2 million and $6.0 million , respectively. Dental revenues decreased by
approximately $2.8 million , which is mostly related to COVID-19
pandemic affecting the Company's customers and other business partners. In the
short-term, demand for the Company's products has decreased, notably in our
dental and medical divisions. Such decreased demand may or may not continue
and/or demand may increase from historical levels depending on the duration and
severity of the COVID-19 pandemic, the length of time it takes for normal
economic and operating conditions to resume, additional governmental actions
that may be taken and/or extensions of time for restrictions that have been
imposed to date, and numerous other uncertainties. Such events may result in
business and manufacturing disruption, inventory shortages, delivery delays, and
reduced sales and operations, any of which could materially affect our business,
financial condition, and results of operations.
As a result of the reduced hours and closings of dental offices throughout the
country and the rest of the world due to the continuing spread of COVID-19, our
revenue for the third quarter was materially and adversely affected. At this
point in time, it is too early to determine an estimate of what the fourth
quarter impact will be, or the effect COVID-19 may have on our first quarter of
2021. In addition, it is too early to determine what the effect will be on the anticipated commercialization of our CompuFlo Epidural system as a medical device in the fourth quarter of 2020 and the first quarter 2021.
Gross Profit for 2020 and 2019 were as follows:
2020 2019 Increase Decrease %
Dental $ 2,191,934 $ 4,168,927 $ (1,976,993 ) -47.42 %
Medical 8,289 10,103 (1,814 ) -17.96 %
Total gross profit $ 2,200,223 $ 4,179,030 $ (1,978,807 ) -47.35 %
Consolidated gross profit for the nine months ended
Selling, general and administrative expenses for 2020 and 2019 were as follows:
Increase
2020 2019 Decrease %
Dental $ 2,226,303 $ 2,402,840 $ (176,537 ) -7.35 %
Medical 2,066,535 1,611,472 455,063 28.24 %
Corporate 3,928,521 2,927,652 1,000,869 34.19 %
Total selling, general and
administrative expenses $ 8,221,359 $ 6,941,964 $ 1,279,395 18.43 %
Consolidated selling, general and administrative expenses for the nine months
ended September 30, 2020 and 2019, were approximately $8.2 million and
6.9 million, respectively. The increase of approximately $1.3 million is
categorized in several areas. Employee salaries, and benefits expenses increased
approximately $1 million during the nine months ended September 30, 2020 , the
Company hired additional employees to work on the commercialization of
the CompuFlo® Epidural System and recorded additional bonuses in 2020. During
the nine months ended September 30, 2020 D&O insurance increase approximately
$117,000 due to the increase of premiums. The company expenses approximately
$370,000 of bad debt related to a settlement with United Systems, See Note 6.
Due to Covid-19 Pandemic, the Company's travel expenses, trade shows and general
expenses decreased approximately $424,000 . Office expense increased
approximately $143,000 associated with the relocation of the Company 's office
and other related costs.
32--------------------------------------------------------------------------------
Research and Development for 2020 and 2019 were as follows:
2020 2019 Increase Decrease %
Dental $ - $ - $ - 0.00 %
Medical 237,089 109,815 127,274 115.90 %
Corporate - -
- 0.00 %
Total research and development
Consolidated research and development expenses for the nine months ended,
Profit (Loss) from Operations for 2020 and 2019 were as follows:
Increase
2020 2019 Decrease %
Dental
Medical $ (32,624 ) $ 1,766,087 $ (1,798,711 ) -101.85 %
Corporate (2,297,080 ) (1,711,184 ) (585,896 ) 34.24 %
Total loss from operations (3,928,521 ) (2,927,652 ) (1,000,869 ) 34.19 %
$ (6,258,225 ) $ (2,872,749 ) $ (3,385,476 ) 117.85 %
The loss from operations was approximately $6.3 million and $2.9 million for the
nine months ending September 30, 2020 and 2019, respectively an increase of
approximately $3.4 million . This increase is the result of a decrease in
revenues due to the reduced hours and closings of dental and medical offices
throughout the country and the rest of the world due to the continuing spread of
COVID-19. We anticipate that our revenue for the fourth quarter, and possibly
the first quarter of 2021, will be materially and adversely affected.
Liquidity and Capital Resources
OnSeptember 30, 2020 ,Milestone Scientific had cash and cash equivalents of approximately$14.4 million and working capital of approximately$15.4 million versus working capital of$1.2 million onDecember 31, 2019 . For the nine months endedSeptember 30, 2020 , we had negative cash flows from operating activities of approximately$6.3 million compared to$1.3 million for the nine months endedSeptember 30, 2019 . In the second quarter of 2020 the Company completed two capital raises. InApril 2020 , the Company completed a Common Stock Offering generating gross proceeds of approximately$5.1 million (5,420,000 common shares and 2,710,000 warrants). The combined price of the shares and warrants was$0.95 per share. The warrants are exercisable at a price of$1.20 per share and have an expiration of three years from the issue date. InJune 2020 , the Company completed a second Common Stock Offering generating gross proceeds of approximately$14.6 million (6,770,000 common shares and 3,749,000 warrants). The combined price of shares and warrants of was$2.15 per share. The warrants are exercisable at a of$2.60 and expire three years from the issue date. See Note 9. With the combination of these two Common Stock Offerings, the Company has sufficient liquidity to support operations for at least a year after the condensed consolidated financial statements issue date.Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue from its dental business worldwide, the generation of revenue from its medical devices and disposables business inthe United States and worldwide, as well as considering other strategic plans or transactions. However, the COVID-19 pandemic is expected to have a continued adverse effect on the Company's operations and cash flows for at least in the next two quarters and possibly longer depending on the length and severity in of the pandemic in important dental markets. Now that the CompuFlo Epidural System has obtained FDA clearance inthe United States (June 2017 ), the development costs were reduced in 2020, but the selling costs are expected to continue to increase. The FDA clearance has provided the Company with the opportunity to establish distribution in theU.S. The Company intends to restart the 510K application process for the intra-articular device , subject to available allocated internal resources. 33
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