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, 2021.
Arjan Haverhals, CEO and President of Milestone
Scientific, stated, "I am pleased to report we achieved 90%
year-over-year growth in revenue to $10.3 million, surpassing our
prior revenue guidance and exceeding pre-pandemic levels. The
growth in our dental division reflects the success of our sales and
marketing initiatives, as well as the expansion of our distribution
network. We are encouraged by the growing interest in our dental
instrument, and expect our momentum to continue in 2022.
Importantly, the dental division remains profitable on a standalone
basis with high gross margins, and we expect to benefit from
economies of scale as we continue to carefully manage our
expenses.”
“We have made progress over the past year
rolling out our CompuFlo® Epidural System. Specifically, we added
new distributors and have begun to penetrate key hospitals,
healthcare systems and pain management clinics. In December alone,
immediately preceding the spike in Omicron cases, we announced the
addition of three leading hospitals, all of which belong to large
healthcare systems. It is important to note that the pandemic had a
disproportionate impact on the labor and delivery departments
within hospitals, as many pregnant women opted out of the vaccine.
This resulted in stricter restrictions than other departments,
which limited our ability to demo and trial the instruments within
the operatories. With the pandemic and Omicron variant now waning,
the restrictions have begun to ease, and we are aggressively
resuming activities, albeit delayed by several months.”
“At the same time, we have expanded our focus to
include pain management centers, which were less impacted by the
pandemic. For instance, this week, we announced an agreement with
Pain Management Specialists in California, and are now selling our
disposables in the first two of their three clinics. Similarly, we
announced that a leading pain management specialist, Dr. Harsh
Govil, has begun using our technology within his practice at
Piedmont Healthcare. Similarly, Dr. Miguel de la Garza, a
recognized leader in pain management and president of the Florida
Society of Interventional Pain Physicians, has begun using our
technology within his practice. He conducts these procedures at
Surgery Partners, which has also approved the CompuFlo Epidural
instrument for use across their network in pain management.”
“We remain committed to our goal of establishing
the CompuFlo Epidural instrument as the new standard of care in
epidural anesthesia by providing patients with effective pain
relief, while reducing the risk of complications. Moreover, we have
a strong cash runway with over $14.8 million of cash and cash
equivalents as of December 31, 2021. This liquidity, combined with
our improving cash flow, will support our ongoing activities,
including accelerated marketing activities around both our dental
and medical instruments.”
For the years ended December 31, 2021 and 2020,
revenues were approximately $10.3 million and $5.4 million,
respectively. Dental revenue increased approximately $4.7 million
for the year ended December 31, 2021, as compared to 2020, due to
the re-opening of dental offices throughout the country, and the
rest of the world, including China. Medical revenue increased
approximately $136,000 for the year ended December 31, 2021, as
compared to 2020 due to the Company arranging meetings at hospital
and pain clinics through the direct sales force and medical device
distributors in European markets. Gross profit for the year ended
December 31, 2021 was $6.3 million or 61% of revenue versus $3.6
million or 67% of revenue for the year ended December 31, 2020.
Operating loss for the year ended December 31, 2021 was
approximately $(7.4) million versus approximately $(7.5) million
for the year ended December 31, 2020. Net loss attributable to
common shareholders was approximately $(6.8) million, or $(0.10)
per share for the year ended December 31, 2021, versus net loss
attributable to common shareholders of $(7.3) million, or $(0.12)
per share, for the comparable period in 2020.
Conference Call
Milestone Scientific’s executive management team
will host a conference call at 8:30 AM Eastern Time on Friday,
April 1, 2022 to discuss the Company’s financial results for the
2021 fiscal year ending December 31, 2021, 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: 639488. A
webcast of the call may be accessed at
https://www.webcaster4.com/Webcast/Page/2306/45018 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 April 15,
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: 45018.
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.
(tables follow)
MILESTONE SCIENTIFIC AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
|
|
December 31, 2021 |
|
|
December 31, 2020 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,764,346 |
|
|
$ |
14,223,917 |
|
Accounts receivable, net |
|
|
943,272 |
|
|
|
1,080,656 |
|
Prepaid expenses and other
current assets |
|
|
375,360 |
|
|
|
415,915 |
|
Inventories, net |
|
|
1,541,513 |
|
|
|
2,420,179 |
|
Advances on contracts |
|
|
1,309,260 |
|
|
|
414,202 |
|
Total current assets |
|
|
18,933,751 |
|
|
|
18,554,869 |
|
Furniture, fixtures and
equipment, net |
|
|
23,713 |
|
|
|
30,729 |
|
Intangibles, net |
|
|
277,619 |
|
|
|
329,249 |
|
Right of use assets |
|
|
550,511 |
|
|
|
632,453 |
|
Other assets |
|
|
24,150 |
|
|
|
24,150 |
|
Total assets |
|
$ |
19,809,744 |
|
|
$ |
19,571,450 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
780,428 |
|
|
$ |
482,972 |
|
Accounts payable, related
party |
|
|
395,857 |
|
|
|
385,138 |
|
Accrued expenses and other
payables |
|
|
1,417,248 |
|
|
|
824,454 |
|
Accrued expenses, related
party |
|
|
414,241 |
|
|
|
586,734 |
|
Current portion of finance
lease liabilities |
|
|
8,545 |
|
|
|
7,796 |
|
Current portion of operating
lease liabilities |
|
|
81,001 |
|
|
|
72,031 |
|
Deferred profit, related
party |
|
|
- |
|
|
|
242,589 |
|
Note payable |
|
|
- |
|
|
|
276,180 |
|
Total current liabilities |
|
|
3,097,320 |
|
|
|
2,877,894 |
|
Non-current portion of finance
lease liabilities |
|
|
20,062 |
|
|
|
28,607 |
|
Non-current portion of
operating lease liabilities |
|
|
476,980 |
|
|
|
557,981 |
|
Total liabilities |
|
$ |
3,594,362 |
|
|
$ |
3,464,482 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Common stock, par value
$.001;authorized 100,000,000 shares; 68,153,336 shares issued and
68,120,003 shares outstanding as December 31, 2021; authorized
85,000,000 shares; 64,171,435 shares issued and 64,138,102 shares
outstanding as December 31, 2020; |
|
|
68,153 |
|
|
|
64,171 |
|
Additional paid in
capital |
|
|
124,915,560 |
|
|
|
117,934,696 |
|
Accumulated deficit |
|
|
(107,704,274 |
) |
|
|
(100,885,957 |
) |
Treasury stock, at cost,
33,333 shares |
|
|
(911,516 |
) |
|
|
(911,516 |
) |
Total Milestone Scientific
Inc. stockholders' equity |
|
|
16,367,923 |
|
|
|
16,201,394 |
|
Noncontrolling interest |
|
|
(152,541 |
) |
|
|
(94,426 |
) |
Total stockholders’
equity |
|
$ |
16,215,382 |
|
|
$ |
16,106,968 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders’ equity |
|
$ |
19,809,744 |
|
|
$ |
19,571,450 |
|
|
|
|
|
|
|
|
|
|
MILESTONE SCIENTIFIC AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
YEARS ENDED DECEMBER 31,
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
10,304,711 |
|
|
$ |
5,437,236 |
|
Cost of products sold |
|
|
3,992,811 |
|
|
|
1,815,924 |
|
Gross profit |
|
|
6,311,900 |
|
|
|
3,621,312 |
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative expenses |
|
|
12,738,362 |
|
|
|
10,670,631 |
|
Research and development
expenses |
|
|
878,210 |
|
|
|
307,850 |
|
Depreciation and amortization
expense |
|
|
73,836 |
|
|
|
95,949 |
|
Total operating expenses |
|
|
13,690,408 |
|
|
|
11,074,430 |
|
Loss from operations |
|
|
(7,378,508 |
) |
|
|
(7,453,118 |
) |
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(16,360 |
) |
|
|
(18,081 |
) |
Gain on debt
extinguishment-PPP |
|
|
276,180 |
|
|
|
- |
|
Loss before provision for
income taxes and net of equity investments |
|
|
(7,118,688 |
) |
|
|
(7,471,199 |
) |
Provision for income
taxes |
|
|
(333 |
) |
|
|
(15,500 |
) |
Loss before equity
investment |
|
|
(7,119,021 |
) |
|
|
(7,486,699 |
) |
Deferred profit and
divesture-equity investment |
|
|
242,589 |
|
|
|
97,887 |
|
Net loss |
|
|
(6,876,432 |
) |
|
|
(7,388,812 |
) |
Net loss attributable to
noncontrolling interests |
|
|
58,115 |
|
|
|
51,539 |
|
Net loss attributable to
Milestone Scientific Inc. |
|
|
(6,818,317 |
) |
|
|
(7,337,273 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share applicable
to common stockholders— |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.10 |
) |
|
$ |
(0.12 |
) |
Diluted |
|
$ |
(0.10 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding and to be issued— |
|
|
|
|
|
|
|
|
Basic |
|
|
68,829,860 |
|
|
|
63,061,358 |
|
Diluted |
|
|
68,829,860 |
|
|
|
63,061,358 |
|
Contact:
David Waldman or
Natalya RudmanCrescendo Communications, LLCEmail:
mlss@crescendo-ir.comTel: 212-671-1020
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