UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
PRE-EFFECTIVE AMENDMENT NO. 1 TO
FORM S-3
REGISTRATION STATEMENT
Under
THE SECURITIES ACT OF 1933
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APYX MEDICAL CORPORATION |
(Exact name of registrant as specified in its charter) |
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Delaware |
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11-2644611 |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification No.) |
5115 Ulmerton Road
Clearwater, FL 33760
(727) 384-2323
(Address, including zip code, and telephone number, including area
code, of Registrant’s principal executive offices)
Charles D. Goodwin, II
Chief Executive Officer
5115 Ulmerton Road
Clearwater, Florida 33760
(727) 384-2323
(Name, address, including zip code, and telephone number, including
area code, of agent for service)
Copy to:
Adam P. Silvers, Esq.
Neil Novikoff, Esq.
Dominick P. Ragno, Esq.
Ruskin Moscou Faltischek, P.C.
1425 RXR Plaza
East Tower, 15th
Floor
Uniondale, New York 11556-1425
(516) 663-6519
______________________________
Approximate date of commencement of proposed sale to the
public:
From time to time after the effective date of this registration
statement.
If the only securities being registered on this Form are being
offered pursuant to dividend or interest reinvestment plans, please
check the following box:
o
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to Rule 415 under
the Securities Act of 1933, other than securities offered only in
connection with dividend or intent reinvestments plans, check the
following box:
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If this Form is filed to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration
statement number of the earlier effective registration statement
for the same offering.
o
If this Form is a post effective amendment filed pursuant to Rule
462(c) under the Securities Act, check the following box and list
the Securities Act registration number of the earlier effective
registration statement for the same offering.
o
If this form is a registration statement pursuant to General
Instruction I.D. or a post-effective amendment thereto that shall
become effective upon filing with the Commission pursuant to Rule
462(e) under the Securities Act, check the following box.
o
If this form is a post-effective amendment to a registration
statement filed pursuant General Instruction I.D. filed to register
additional securities or additional classes of securities pursuant
to Rule 413(b) under the Securities Act, check the following
box.
o
Indicate by check mark whether registrant is a large accelerated
filer, an accelerated filer, a non accelerated filer, or a smaller
reporting company, or an emerging growth company.
See definitions of “large accelerated filer”, “accelerated filer”,
“smaller reporting company” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
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Large
accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act. |
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THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH
DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL
THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY
STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME
EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE SECURITIES ACT OF
1933, AS AMENDED, OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE SECURITIES AND EXCHANGE COMMISSION
ACTING PURSUANT TO SAID SECTION 8(a), MAY DETERMINE.
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EXPLANATORY NOTE
The sole purpose of this Pre-Effective Amendment No. 1 to the
Registration Statement on Form S-3, initially filed on November 22,
2022 (File No. 333-268532) (the “Registration Statement”), is to
update the sections entitled “Dilution” and “Risk Factors” in the
equity distribution agreement prospectus therein to correct a
discrepancy in the dilution per share to investors purchasing our
common stock. This figure has been revised from $0.13 to $0.14 per
share in the body of the sections entitled “Dilution” and “Risk
Factors”. Accordingly, this Pre-Effective Amendment No. 1 consists
only of the facing page, this explanatory note, the updated equity
distribution agreement prospectus (reflecting only a change to the
sections entitled “Dilution” and “Risk Factors”), Part II of the
Registration Statement and the signature page of the Registration
Statement. This Pre-Effective Amendment is not intended to amend or
delete any part of the Registration Statement except as
specifically noted herein.
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE
CHANGED. THESE SECURITIES WILL NOT BE SOLD UNTIL THE REGISTRATION
STATEMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION IS
EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL THESE
SECURITIES, AND IT IS NOT SOLICITING AN OFFER TO BUY THESE
SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT
PERMITTED.
SUBJECT TO COMPLETION, DATED November 22, 2022
Up to $40,000,000
Common Stock
We have entered into an equity distribution agreement (the “Equity
Distribution Agreement”) with Piper Sandler & Co. (“Piper
Sandler”), relating to shares of our common stock offered by this
prospectus. In accordance with the terms of the Equity Distribution
Agreement, pursuant to this prospectus, we may offer and sell
shares of our common stock, $0.001 par value, having an aggregate
offering price of up to $40,000,000 from time to time through Piper
Sandler acting as our agent.
Our common stock is listed on the NASDAQ Stock Market LLC under the
symbol “APYX.” On November 21, 2022, the last reported sale price
of our common stock was $1.42 per share.
Sales of our common stock, if any, under this prospectus will be
made in sales deemed to be “at the market offerings” as defined in
Rule 415(a)(4) promulgated under the Securities Act of 1933, as
amended, or (the “Securities Act”). Piper Sandler will act as our
agent on a best efforts basis and will use commercially reasonable
efforts to sell on our behalf all of the shares of common stock
requested to be sold by us, consistent with its normal trading and
sales practices, on mutually agreed terms between Piper Sandler and
us. There is no arrangement for funds to be received in any escrow,
trust or similar arrangement.
Piper Sandler will be entitled to compensation at a fixed
commission rate of 3.0% of the gross proceeds of any shares of
common stock sold pursuant to the Equity Distribution Agreement.
See “Plan
of Distribution”
for additional information regarding compensation to be paid to
Piper Sandler. In connection with the sale of the common stock on
our behalf, Piper Sandler will be deemed to be an “underwriter”
within the meaning of the Securities Act and the compensation of
Piper Sandler will be deemed to be underwriting commissions or
discounts. We have also agreed to provide indemnification and
contribution to Piper Sandler with respect to certain liabilities,
including liabilities under the Securities Act and the Exchange Act
of 1934, as amended (the “Exchange Act”).
INVESTING IN OUR SECURITIES INVOLVES A HIGH DEGREE OF RISK. YOU
SHOULD REVIEW CAREFULLY THE RISKS AND UNCERTAINTIES REFERENCED
UNDER THE HEADING “RISK FACTORS” ON PAGE
12
OF THIS PROSPECTUS AS WELL AS THOSE CONTAINED IN THE APPLICABLE
PROSPECTUS SUPPLEMENT AND ANY RELATED FREE WRITING PROSPECTUS, AND
IN THE OTHER DOCUMENTS THAT ARE INCORPORATED BY REFERENCE INTO THIS
PROSPECTUS.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE
SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE
SECURITIES OR PASSED UPON THE ACCURACY OR ADEQUACY OF THIS
PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENSE.
Piper Sandler
THE DATE OF THIS PROSPECTUS IS __________, 2022
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TABLE OF CONTENTS |
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Prospectus |
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ABOUT THIS PROSPECTUS
This prospectus relates to the registration statement on Form S-3
that we filed with the Securities and Exchange Commission (the
“SEC”) utilizing a “shelf” registration process. Under this shelf
registration process, we may from time to time sell shares of our
common stock. Under this prospectus, we may from time to time sell
shares of our common stock having an aggregate offering price of up
to $40,000,000, at prices and on terms to be determined by market
conditions at the time of the offering. Before buying any of the
common stock that we are offering, we urge you to carefully read
this prospectus, any prospectus supplement, and the information
incorporated by reference as described under the headings
“Where
You Can Find More Information”
and “Incorporation
of Certain Information by Reference”
herein and therein. These documents contain important information
that you should consider when making your investment
decision.
This prospectus describes the terms of this offering of common
stock and also adds to and updates information contained in the
documents incorporated by reference into this prospectus. To the
extent there is a conflict between the information contained in
this prospectus, on the one hand, and the information contained in
any document incorporated by reference into this prospectus that
was filed with the SEC, before the date of this prospectus, on the
other hand, you should rely on the information in this prospectus.
If any statement in one of these documents is inconsistent with a
statement in another document having a later date (for example, a
document incorporated by reference into this prospectus) the
statement in the document having the later date modifies or
supersedes the earlier statement. The information contained in this
prospectus or any free writing prospectus, or incorporated by
reference herein or therein, is accurate only as of the respective
dates thereof, regardless of the time of delivery of this
prospectus or of any sale of our shares of common stock. Our
business, financial condition, results of operations and prospects
may have changed since those dates.
We further note that the representations, warranties and covenants
made by us in any agreement that is filed as an exhibit to any
document that is incorporated by reference herein were made solely
for the benefit of the parties to such agreement, including, in
some cases, for the purpose of allocating risk among the parties to
such agreements, and should not be deemed to be a representation,
warranty or covenant to you. Moreover, such representations,
warranties or covenants were accurate only as of the date when
made. Accordingly, such representations, warranties and covenants
should not be relied on as accurately representing the current
state of our affairs.
We have not, and Piper Sandler has not, authorized anyone to
provide any information other than that contained or incorporated
by reference in this prospectus, any prospectus supplement or in
any free writing prospectus prepared by or on behalf of us or to
which we have referred you. We take no responsibility for, and can
provide no assurance as to the reliability of, any other
information that others may give you. This prospectus does not
constitute an offer to sell, or a solicitation of an offer to
purchase, the securities offered by this prospectus in any
jurisdiction to or from any person to whom or from whom it is
unlawful to make such offer or solicitation of an offer in such
jurisdiction.
Unless the context indicates otherwise, references in this
prospectus to “Apyx,” “Apyx Medical,” or the “Company,” “we,” “us,”
“our” and similar terms refer to Apyx Medical
Corporation.
We own or have rights to trademarks, service marks and trade names
that we use in connection with the operation of our business,
including our corporate name, logos and website names. Other
trademarks, service marks and trade names appearing in this
prospectus are the property of their respective owners. Solely for
convenience, some of the trademarks, service marks and trade names
referred to in this prospectus are listed without the ® and ™
symbols, but we will assert, to the fullest extent under applicable
law, our rights to our trademarks, service marks and trade
names.
PROSPECTUS SUMMARY
The following highlights information about the Registrant and our
business contained elsewhere or incorporated by reference in this
prospectus. It is not complete and does not contain all of the
information that you should consider before investing in any of our
securities. You should carefully read this prospectus together with
the more detailed information incorporated by reference in this
prospectus.
Our Company
Overview
Apyx Medical Corporation (“Company”, “Apyx Medical”, “we”, “us”, or
“our”) was incorporated in 1982, under the laws of the State of
Delaware and has its principal executive office at 5115 Ulmerton
Road, Clearwater, FL 33760.
We are an advanced energy technology company with a passion for
elevating people’s lives through innovative products in the
cosmetic and surgical markets. Known for our innovative Helium
Plasma Technology, Apyx is solely focused on bringing
transformative solutions to physicians and their patients. Our
Helium Plasma Technology is marketed and sold as Renuvion® in the
cosmetic surgery market and J-Plasma® in the hospital surgical
market. Our primary focus is on the cosmetic surgery market where
Renuvion® offers plastic surgeons, fascial plastic surgeons and
cosmetic physicians a unique ability to provide controlled heat to
the tissue to achieve their desired results. We also leverage our
deep expertise and decades of experience in unique waveforms
through original equipment manufacturing (“OEM”) agreements with
other medical device manufacturers.
Our objective is to achieve profitable, sustainable growth by
increasing our market share in the Advanced Energy category,
including the commercialization of products that have the potential
to be transformational with respect to the results they produce for
surgeons and their patients. In order to achieve this objective, we
plan to leverage our long history in the industry, along with a
reputation for quality, reliability, and a science-based approach
that our brand enjoys within the medical community.
Significant Subsidiaries
Apyx Bulgaria, EOOD is a wholly owned limited liability company
incorporated under Bulgarian law, located in Sofia, Bulgaria. It is
engaged in the business of development and manufacturing of our
advanced energy generators, as well as the manufacturing of our
disposable handpieces and OEM generators and accessories. The
facility also distributes products directly to customers in certain
international markets and provides warranty and repair
services.
Industry
The cosmetic surgery market is a special segment of the medical
field which is involved in the restoration, reconstruction, or
alteration of the human body so as to enhance the body’s
appearance. The market for cosmetic surgery includes surgical,
minimally invasive, and nonsurgical cosmetic procedures. This
market is expected to have steady growth year-over-year and this
growth is driven by social and cultural factors such as the
influence of social media, peer pressure for appearance and beauty,
and increasing disposable income.
We believe that we have sustainable, competitive advantages in the
cosmetic surgery market for several reasons: our long history of
developing unique energy devices to meet the needs of physicians,
our unique Helium Plasma Technology, our outstanding product
quality supported by strong engineering and research and
development capabilities, and the clinical support that our
expanding global medial affairs team provides to our customers. We
feel that our products and our strategy as a customer-centric
aesthetic medical device manufacturer have, and will continue to
improve, the lives of doctors and their patients.
Intellectual Property
We rely on our intellectual property that we have developed or
acquired over the years including patents, trade secrets, technical
innovations and various licensing agreements to provide our future
growth and build our competitive position. We have been issued 40
patents in the United States and 28 foreign patents. We have 22
pending patent applications in the United States and 58 pending
foreign applications. We have 9 U.S. registered trademarks, 5
international registered trademarks, and 4 pending international
trademark applications. As we continue to expand our intellectual
property portfolio, we believe it is critical for us to continue to
invest in filing patent applications to protect our technology,
inventions and improvements. However, we can give no assurance that
competitors will not infringe on our patent rights or otherwise
create similar or non-infringing competing products that are
technically patentable in their own right.
Manufacturing and Suppliers
We are committed to producing the most technically advanced and
highest quality products of their kind available on the market. We
manufacture the majority of our products on our premises in
Clearwater, Florida and at our facility located in Sofia, Bulgaria,
both of which are certified under the ISO international quality
standards and are subject to continuing regulation and routine
inspections by the U.S. Food and Drug Administration (“FDA”) to
ensure compliance with regulations relating to our quality system,
medical device complaint reporting, and adherence to FDA
restrictions on promotion and advertising. In addition, we are
subject to regulations under the Occupational Safety and Health
Act, the Environmental Protection Act and other federal, state and
local regulations, as well as international laws and
regulations.
Apyx Bulgaria, EOOD operates an approximately 25,000 square foot,
ISO13485 certified and FDA registered manufacturing facility
located in the capital city of Sofia, which houses manufacturing,
development and assembly operations.
We work closely with our suppliers to ensure that our raw material
inventory (i.e., semiconductors and plastics) needs are met, while
maintaining high quality and reliability. To date, we have
experienced some delays in locating and obtaining the materials
necessary to fulfill our production requirements, but such delays
have not caused a meaningful backlog of sales orders.
However, it is possible that a prolonged COVID-19 disruption to the
global supply chain could cause a backlog of sales orders in the
future.
We continue to work to find other sources of supply, where
feasible, and have
expedited
the shipments of certain raw material items to adequately maintain
our production and safety stock levels, resulting in higher
shipping costs.
We have also experienced some impact on the purchase prices of our
raw materials due to inflation, global inventory shortages. and
increased demand across the manufacturing sector.
We maintain collaborative arrangements with three foreign
suppliers, including our contract component manufacturer located in
Ningbo, China, under which we request the development of certain
products which we purchase pursuant to purchase orders. Our
purchase order commitments are never more than one year in duration
and are supported by our sales forecasts. To our knowledge, none of
the products that we source are through entities manufacturing in
the Xinjiang province.
During late 2019, we entered into a joint venture with our Chinese
supplier to establish a foundation for the manufacturing and sale
of our Advanced Energy products into the Chinese market. As of the
date of this report, the joint venture has not commenced its
principal operations.
Backlog
The value of unshipped factory orders is not material.
Sustainability
We have created a strong environmental, social and governance
(“ESG”) structure by introducing a new cross-functional ESG team
which has been working with senior management, our board and other
stakeholders to develop an ESG framework that is aligned with our
corporate mission, vision and values. In the third quarter of 2022,
we published our first ESG-focused disclosure under the
sector-specific ESG standards published by the Sustainability
Accounting Standards Board (“SASB”).
Human Capital Management
At November 21, 2022, we had 282 full-time employees world-wide, of
whom 4 were executive officers, 43 were supervisory personnel, 38
were sales personnel and 197 were technical support, administrative
and production employees. None of our current employees are covered
by a collective bargaining agreement and we have never experienced
a work stoppage. During 2021, our voluntary employee turnover rate
was approximately 15%.
Diversity, Equity and Inclusion
We have worked to create a culture that fosters employee
engagement, where diverse talent is productive and passionate about
the work they do. We continuously focus our efforts on cultivating
and enhancing our working culture that embraces equality, diversity
and inclusion. Currently, over half of our global workforce is
represented by women, including half of our executive management
team. In addition, in the U.S., approximately 40% of our employees
are from minority ethnic\racial groups.
Recruitment, Training and Development
The implementation of our growth strategy largely depends on our
ability to hire, train, and retain our workforce. Our recruitment
practices include cross-functional departmental interviewing,
allowing for the best fit not just for a specific department, but
the Company as a whole. We also ensure all of our employees are
fully trained and competent for the role for which they were hired.
In addition, we train our sales professionals to thoroughly
understand our Helium Plasma Technology and the marketplace in
which we compete, including how our technologies can increase our
customer's revenue and the results they are able to achieve for
their patients.
Compensation and Benefits
Our compensation programs are designed to align the compensation of
our employees with our performance, and to provide the proper
incentives to attract, retain and motivate them to achieve superior
results. The structure of our compensation programs balances
incentive earnings for both short-term and long-term performance,
specifically:
•We
offer wages that are competitive and consistent with employee
positions, skill levels, experience, knowledge and geographic
location;
•Our
compensation practices are fair and equitable across all levels of
the organization, from our Executive Officers to our hourly
employees;
•We
work with both local and nationally recognized outside compensation
and benefits consulting firms to independently evaluate the
effectiveness of our executive and non-executive compensation and
benefit programs and to provide benchmarking against our peers
within our industry;
•We
may provide our non-hourly U.S-based employees long term incentives
in the form of stock options to help foster a culture of ownership,
and empower individuals to drive continuous improvements to
increase stockholder value;
•Annual
increases and incentive compensation are based on merit, which is
communicated to employees at the time of hiring and documented
through our talent management process as part of our annual review
procedures and upon internal transfer and/or
promotion;
•All
employees are eligible for health insurance, paid and unpaid
leaves, a retirement plan, and life and disability/accident
coverage. We also offer a variety of voluntary benefits that allow
employees to select the options that meet their needs.
Culture
We are a solution focused company in the cosmetic surgery market
and the broader medical technology sector, and endeavor to provide
unique and creative solutions for the ever-changing needs of our
physician customers and their patients. Our mission and vision are
to be the world’s leading innovator in unique energy solutions that
continually reshape what’s possible in cosmetic and medical
procedures through innovative solutions.
Our shared values of transforming physicians’ and their patients’
lives, acting with integrity, and driving innovation, form the core
of our company's culture. We articulate the qualities associated
with these behaviors through our three Core Values:
•Trailblazers:
We are passionate about the work we do. We energetically pursue our
goals, aim higher, and reach further. When we encounter setbacks,
we see opportunities for innovation and improvement. When we clear
a business hurdle, we celebrate, and then raise the
bar.
•Challengers:
We speak up and are not afraid to question, to reimagine, to think
differently. We innovate to break the status quo, and create new
possibilities, for our customers and for our company.
•Team
Players:
We respect everyone’s contribution, and are absolutely committed to
elevating our fellow team members, and our customers and their
patients.
Employee Health and Safety
The health and safety of our employees is our highest priority, and
this is consistent with our operating philosophy. We provide a safe
and healthy workplace for employees consistent with the
requirements of the Occupational Safety and Health Act. We aim to
prevent any employee, visitor, customer, or person from being
subjected to any health or safety risks. We provide annual training
and expect our employees to diligently work towards the maintenance
of safe and healthy working conditions, adhere to proper operating
practices and procedures designed to prevent injury and illness,
and conscientiously observe all safety regulations. Our commitment
to the safety and well-being of our employees is shown through
safety walkthroughs by our Safety Committee, as well as having an
open-door policy, allowing employees to feel comfortable bringing
up any safety concerns to management or Human Resources. Identified
concerns and potential hazards are addressed immediately, which is
evidenced by our low safety incident rate quarter over quarter. In
2021, we had only one lost time accident.
In addition, in our response to the COVID-19 pandemic around the
globe, we supported our employees and their families
by:
•Adding
work from home flexibility;
•Adjusting
attendance policies to encourage those who are sick to stay
home;
•Increasing
cleaning protocols;
•Establishing
new physical distancing procedures for employees who need to be
onsite;
•Providing
additional personal protective equipment and cleaning
supplies;
•Implementing
protocols to address actual and suspected COVID-19 cases and
potential exposure;
•Limiting
domestic and international non-essential travel for all employees;
and
•Requiring
masks to be worn at all locations where allowed by local
law.
Our Two Business Segments
We currently have two reportable segments: Advanced Energy and OEM.
The Corporate and Other category includes certain unallocated
corporate and administrative costs which are not specifically
attributed to either reportable segment. Net assets are shared,
therefore, not allocated to the reportable segments.
For the year ended December 31, 2021, our
OEM segment contributed 11.4% of our consolidated total revenue and
our Advanced Energy segment contributed 88.6% of our consolidated
total revenue.
Advanced Energy Segment
Our product portfolio consists of our Helium Plasma Technology that
is marketed and sold as Renuvion® in the cosmetic surgery market
and J-Plasma® in the hospital surgical market. Our primary focus is
on the cosmetic surgery market where Renuvion® offers plastic
surgeons, fascial plastic surgeons and cosmetic physicians a unique
ability to provide controlled heat to the tissue to achieve their
desired results. This technology has U.S. FDA clearance, CE mark,
and clearance for sale in multiple other countries and is generally
indicated for the cutting, coagulation and ablation of soft tissue.
The system consists of an electrosurgical generator unit (“ESU”), a
handpiece and a supply of helium gas. The proprietary
radiofrequency (“RF”) energy is delivered to the handpiece by the
ESU and used to energize an electrode. When helium gas passes over
the energized electrode, helium plasma is generated which allows
for conduction of the RF energy from the electrode to the patient
in the form of a precise helium plasma beam. The energy delivered
to the patient via the helium plasma beam is unique in that it
allows for the application of heat to tissue in a way that is not
possible with traditional monopolar or bipolar technologies. This
technology has been the subject of forty-two peer-reviewed journal
articles, book chapters, abstracts, and posters. It also continues
to be the subject of numerous presentations at traditional and
cosmetic surgery conferences around the world.
This technology initially received FDA clearance in 2012 and a CE
mark in December 2014, which enables us to sell the product in the
European Union. In 2014, we created and trained a direct sales
force dedicated to sell this technology. In 2015, we continued the
commercialization process for our Helium Plasma Technology with a
multi-faceted strategy designed to accelerate adoption of the
product. This strategy primarily involved deployment of a dedicated
sales force, developing product line extensions and expanding the
specialties in which this technology can become the “standard of
care” for certain procedures.
We continue our full-scale, global, commercialization efforts for
Renuvion® in the cosmetic and plastic surgery markets. As of
September 30, 2022, we had a direct sales force of 35 field-based
selling professionals and utilized 3 independent sales agencies. We
also had 4 sales managers. This selling organization is focused on
the use of Renuvion® in the cosmetic surgery market, supported by
our global medical affairs team. This global team of clinical
support specialists focuses on supporting our users to ensure
optimal outcomes for their patients. In addition, we have invested
in training programs and marketing-related activities to support
accelerated adoption of Renuvion® into physicians'
practices.
From 2015 through the present, we launched numerous new extensions
to our Helium Plasma product lines in an effort to target new
surgical procedures, users, and markets. Most notably, throughout
2021, we continued our launch of our Renuvion® Apyx Plasma RF
handpieces (“APR”) around the world. These handpieces were designed
with improved ergonomics and usability for our Renuvion® customers.
As a result of our sales, marketing and product development
initiatives, we have significantly increased the number of
physicians using our Helium Plasma Technology by expanding usage to
include the cosmetic surgery market in the U.S., and the cosmetic
surgery market as well as the surgical oncology market outside the
U.S.
As part of our plan to accelerate and fully fund the development of
our advanced energy business, with a focus in the cosmetic surgery
market, we sold our Core business in 2018 for gross proceeds of $97
million. These proceeds were used to launch broad marketing and
sales initiatives which resulted in rapid sales growth through
December 31, 2021 and into the first quarter of 2022. This planned
growth in the business was accompanied by scaled operations,
including procurement of components, expanded manufacturing
capacity to turn those materials into saleable inventory,
additional discretionary expenditures, including increased global
participation at trade shows, additional employee trainings, user
meetings, increased travel and entertainment expenses, more
expansive research and development projects, and additional
headcount to support those activities. Additionally, we had and
still have, some significant non-recurring discretionary
expenditures associated with completing our multi-year marketing
initiatives related to our dermal resurfacing and skin laxity
clearances.
We continue to make substantial investments in the development and
marketing of our Renuvion® technology for the long-term benefit of
the Company and its stakeholders, and this may adversely affect our
short-term operating performance and cash flows, particularly over
the next 12 to 18 months. While we believe that these investments
have the potential to generate additional revenues and profits in
the future, there can be no assurance that our Helium Plasma
Technology will continue to be successful or that such future
revenues and profitability will be realized.
In order to assist us in leveraging our Helium Plasma Technology’s
precision and effectiveness in multiple surgical specialties, we
continue to utilize our Medical Advisory Board which currently
consists of 5 members representing the plastic surgery, fascial
plastic surgery, and cosmetic procedure specialties.
Our commercial strategy in the U.S. and outside the U.S. is
primarily focused on advancing the usage of Renuvion® in the
cosmetic surgery market. In some of our international markets, we
continue to provide support to our customers who have adopted our
J-Plasma® technology for the hospital surgical market. We continue
to develop a clinical and regulatory strategy, and corresponding
marketing campaigns, to support our market focus. We also continue
to expand the reach of our global medical affairs team in order to
provide clinical support to our customers in all
markets.
On February 18, 2022, we received a request from the FDA for
information concerning certain medical device reports which we had
filed with the agency. We fully cooperated with the agency and
provided the FDA with the requested information. On March 14, 2022,
the FDA posted a Medical Device Safety Communication (“Safety
Communication”) that warns consumers and health care providers
against the use of our Advanced Energy products outside of their
FDA-cleared indications for general use in cutting, coagulation,
and ablation of soft tissue during open and laparoscopic surgical
procedures. Following the Safety Communication, we experienced
slowed demand for the adoption of our Helium Plasma
Technology.
On May 26, 2022, we announced that we received 510(k) clearance
from the FDA for the use of the Renuvion Dermal Handpiece for
specific dermal resurfacing procedures. On July 18, 2022, we
announced that we received 510(k) clearance from the FDA for the
use of the Renuvion® APR Handpiece for certain skin contraction
procedures. While we expected that receiving these clearances would
materially mitigate the financial effects of the Safety
Communication in future periods, we continue to experience reduced
demand for the adoption and utilization of our technology and we
believe that this may have an adverse effect in future
periods.
On June 2, 2022, and July 21, 2022, the FDA updated the Safety
Communication to recognize the new 510(k) clearances for the
Renuvion® Dermal handpiece, and the expanded indications for the
Renuvion® APR handpieces. The 510(k) clearance for the Renuvion®
Dermal handpiece allows surgeons to perform dermal resurfacing
procedures for the treatment of moderate to severe wrinkles and
rhytides, limited to patients with Fitzpatrick Skin Types I, II or
III. The 510(k) clearance for the Renuvion® APR handpieces now
addresses improving the appearance of lax (loose) skin in the neck
and submental region.
Customers
In the U.S., we primarily sell our Renuvion® products through our
direct sales force to physicians, cosmetic surgery offices and
surgical centers. Outside of the U.S., all of our products are sold
primarily through our distributor network.
Products
Our Advanced Energy Products consist of our Helium Plasma
Technology lines (Renuvion® and J-Plasma®). These product lines
consist of a multifunction generator, a handpiece and a supply of
helium gas. RF energy is delivered to the handpiece by the
generator and used to energize an electrode. When helium gas passes
over the energized electrode, helium plasma is generated which
allows for conduction of the RF energy from the electrode to the
patient in the form of a precise helium plasma beam. The energy
delivered to the patient via the helium plasma beam is unique in
that it allows for the application of heat to tissue in a way that
is not possible with traditional monopolar or bipolar
technologies.
Helium Plasma Generator
Throughout 2021, we continued our launch of the newest generation
of our Renuvion® generator, the Renuvion® System 3, to markets
outside the U.S. This high frequency electrosurgical generator can
be used for delivery of RF energy and/or helium plasma to cut,
coagulate and ablate soft tissue during open and laparoscopic
surgical procedures. This new generator was built for use with our
Renuvion® APR handpieces, and features enhanced capabilities such
as a joule counter, capable of displaying energy delivered to the
patient, and new Auto-Bipolar functionality, which expands the
surgical capabilities of the system. These new product releases
continue to expand the procedure base for our Helium Plasma
Technology by providing surgeons with the tools they need to access
additional anatomic locations and perform specific
procedures.
Disposable Portfolio
We offer a variety of different hand pieces for open and
laparoscopic procedures. The helium-based plasma generated from
these devices has been shown to provide increased precision and
control and cause less thermal damage to tissue than CO2 laser,
argon plasma and RF energy products currently available on the
market. The technology has a general indication and can be used for
cutting, coagulating and ablating soft tissue. The advantages of
helium plasma continue to be studied throughout the medical and
scientific communities. We believe that cosmetic surgery
applications are the primary area of opportunity for this
technology. In 2020, we completed the launch of our new generation
APR handpieces in the U.S. market. During 2021, we began to launch
these new
handpieces in our international markets, designed specifically for
minimally invasive use, with improved ergonomics and safety
features.
Competition
Currently, we are the only company with helium-based plasma and
retractable blade products. However, there are RF based
competitors, argon plasma competitors, and CO2 laser competitors
for our target market. We believe our competitive position has not
changed.
Litigation
The medical device industry is characterized by frequent claims and
litigation, and the Company may become subject to various claims,
lawsuits and proceedings in the ordinary course of our business.
Such claims may include claims by current or former employees,
distributors and competitors, claims concerning the marketing and
promotion of our products and product liability
claims.
In addition to a securities class action that was previously
disclosed with the SEC, the Company is involved in a number of
legal actions relating to the use of our Helium Plasma technology
stemming from claims of alleged negligence in marketing, promotion
of off-label uses of the Company’s products, product liability
claims and/or complaints of alleged medical negligence by
physicians employing the Company’s devices. The outcomes of these
legal actions are not within the Company’s control and may not be
known for prolonged periods of time. It believes that such claims
are adequately covered by insurance; however, in the case of one of
the Company’s carriers, the Company is in a dispute regarding the
total level of coverage available. Notwithstanding the foregoing,
in the opinion of management, the Company has meritorious defenses,
and such claims are not expected, individually or in the aggregate,
to result in a material, adverse effect on its financial condition,
results of operations and cash flows. However, in the event that
damages exceed the aggregate coverage limits of the Company’s
policies or if its insurance carriers disclaim coverage, management
believes it is possible that costs associated with these claims
could have a material adverse impact on our consolidated financial
condition, results of operations and cash flows.
FDA and Other Government Regulations
Our products are medical devices that are subject to extensive
regulation by the U.S. FDA, as well as by other regulatory bodies
in the United States and abroad. The FDA classifies medical devices
into one of three classes based on the risks associated with the
medical device and the controls deemed necessary to reasonably
ensure the device’s safety and effectiveness. Those three classes
are:
•Class
I, the lowest risk products, which require compliance with medical
device general controls, including labeling, establishment
registration, device product listing, adverse event reporting and,
for some products, adherence to good manufacturing practices
through the FDA’s quality system regulations;
•Class
II, comprising moderate-risk devices, which also require compliance
with general controls and in some cases, so called special controls
that may include performance standards, particular labeling
requirements, or post-market surveillance obligations; typically a
Class II device also requires pre-market review and clearance by
FDA of a pre-market notification (also referred to as a “510(k)
application”) as well as adherence to the quality system
regulations/good manufacturing practices for devices;
and
•Class
III, high-risk devices that are often implantable or
life-sustaining, which also require compliance with the medical
device general controls and quality system regulations, but which
generally must be approved by FDA before entering the market,
through a more-lengthy pre-market approval (PMA) application.
Approved PMAs can include post-approval conditions and post-market
surveillance requirements, analogous to some of the special
controls that may be imposed on Class II devices.
Before being introduced into the U.S. market, our products must
obtain marketing clearance or approval from FDA through the
510(k)-pre-market notification, or premarket approval processes. To
date, our products have been classified as Class II, moderate-risk
medical devices that are substantially equivalent to a legally
marketed device and, thus, have been subject to the 510(k) review
and clearance process.
510(k) Pre-Market Notification Process
Class II devices typically require pre-market review and clearance
by the FDA, which is accomplished through the submission of a
510(k)-pre-market notification before the device may be marketed.
To obtain 510(k) clearance, we must demonstrate that a new device
is substantially equivalent to another device with 510(k) clearance
or grandfathered status, or to a device that was reclassified from
Class III to Class II or Class I - this device to which the new
device is compared is called the “predicate device.” In some cases,
we may be required to perform clinical trials to support a claim of
substantial equivalence. If clinical trials are required, we may be
required to submit an application for an investigational device
exemption, or IDE, which must be cleared by the FDA prior to the
start of a clinical investigation, unless the device and clinical
investigation are considered non-significant risk by the FDA or are
exempt from the IDE requirements.
Whether or not an IDE is required for a clinical study involving a
medical device, an appropriate Institutional Review Board (IRB)
must review and approve the study protocol before it is initiated.
It generally takes three months from the date of the pre-market
notification submission to obtain a final 510(k) clearance decision
from the FDA, but it can be significantly longer. After a medical
device receives a 510(k)-clearance letter, which authorizes
commercial marketing of the new device for one or more specific
indications for use, any modification that could significantly
affect its safety or effectiveness, or that would constitute a
major change in its intended use, requires the submission of a new
510(k) notification or could require de novo classification or a
PMA. The FDA allows each company to make this determination, but
the FDA can review the decision as part of routine compliance
audits of the company. If the FDA disagrees with a company’s
decision not to seek prior FDA authorization, the FDA may require
the company to seek additional 510(k) clearance or pre-market
approval. The FDA also can require the company to cease marketing
and/or recall the medical device in question until its regulatory
status is resolved.
Post-Marketing Compliance Obligations
Regardless of which pre-market pathway a medical device uses to
reach the U.S. market, after a device is placed on the market,
numerous regulatory requirements continue to apply. These
include:
•the
FDA’s Quality System Regulation (“QSR”), which requires
manufacturers, including third-party manufacturers, to follow
stringent design, testing, control, documentation and other good
manufacturing practice and quality assurance procedures during all
aspects of the manufacturing process (unless a device category is
exempt from this requirement by the FDA, such as in the case of
many Class I devices);
•labeling
regulations and FDA prohibitions against the promotion of products
for uncleared or unapproved uses (known as off-label uses), as well
as requirements to provide adequate information on both risks and
benefits;
•medical
device reporting regulations, which require that manufacturers
report to FDA any event that the company learns of in which a
device may have caused or contributed to a death or serious injury
or malfunctioned in a way that would likely cause or contribute to
a death or serious injury if the malfunction were to
recur;
•correction
and removal reporting regulations, which require that manufacturers
report to the FDA field corrections and device recalls or removals
if undertaken to reduce a risk to health by the device or to remedy
a violation of the U.S. Food Drug and Cosmetic Act caused by the
device that may present a risk to health;
•post-market
surveillance regulations, which apply to Class II or III devices if
the FDA has issued a post-market surveillance order and the failure
of the device would be reasonably likely to have serious adverse
health consequences, the device is expected to have significant use
in the pediatric population, the device is intended to be implanted
in the human body for more than one year, or the device is intended
to be used to support or sustain life and to be used outside a user
facility;
•regular
and for-cause inspections by FDA to review a manufacturer’s
facility and its compliance with applicable FDA requirements;
and
•the
FDA’s recall authority, whereby it can ask, or order, device
manufacturers to recall from the market a product that is in
violation of applicable laws and regulations.
Because our customers are health care providers, our business may
also be subject to state, federal, and foreign laws and regulations
prohibiting health care fraud, waste, and abuse and requiring
pricing and financial relationship transparency.
On February 18, 2022, we received a request from the FDA for
information concerning certain medical device reports which we had
filed with the agency. We fully cooperated with the agency and
provided the FDA with the requested information. On March 14, 2022,
the FDA posted a Medical Device Safety Communication that warns
consumers and health care providers against the use of our Advanced
Energy products outside of their FDA-cleared indications for
general use in cutting, coagulation, and ablation of soft tissue
during open and laparoscopic surgical procedures. We continue to
work with the FDA towards securing 510(k) clearance for additional
indications. We are in the process of evaluating what effects, if
any, the Safety Communication will have on our results of
operations, cash flows and financial position.
On June 2, 2022, and July 21, 2022, FDA updated the Medical Device
Safety Communication to recognize the new 510(k) clearances for the
Renuvion® Dermal handpiece, and the expanded indications for the
Renuvion® APR handpieces. The 510(k) clearance for the Renuvion®
Dermal handpiece allows surgeons to perform dermal resurfacing
procedures for the treatment of moderate to severe wrinkles and
rhytides, limited to patients with Fitzpatrick Skin Types I, II or
III. The 510(k) clearance for the Renuvion® APR handpieces now
addresses improving the appearance of lax (loose) skin in the neck
and submental region.
Medical Device Single Audit Program (“MDSAP”)
The International Medical Device Regulators Forum (the “IMDRF”)
recognized that a global approach to auditing and monitoring the
manufacturing of medical devices could improve their safety and
oversight on an international scale. The IMDRF established a work
group that developed specific documents to advance a MDSAP. The
Medical Device Single Audit Program allowed MDSAP recognized
Auditing Organizations to conduct a single regulatory audit of a
medical device manufacturer to satisfy the relevant
requirements of the regulatory authorities participating in the
program. Based on its evaluation of the MDSAP Final Pilot Report,
the MDSAP Regulatory Authority Council (the international MDSAP
governing body) determined that the MDSAP Pilot had satisfactorily
demonstrated the viability of the Medical Device Single Audit
Program. In October 2021, we underwent a successful annual MDSAP
audit our registrar GMED SAS. There were no observations related to
safety or efficacy of our products noted during this MDSAP audit.
The FDA accepts MDSAP audit reports as a substitute for routine
Agency inspections.
OEM Segment
We leverage our expertise in the design, development and
manufacturing of electrosurgical equipment by producing generators
and related accessories for large, well-known medical device
manufacturers through OEM agreements, as well as start-up companies
with the need for our energy-based designs. In connection with the
Asset Purchase Agreement with Symmetry Surgical in 2018, we entered
into a Manufacturing and Supply Agreement for a ten-year term,
whereby we will manufacture certain products and sell to them at
agreed upon prices. Revenue, costs and expenses resulting from this
agreement are reported in our Consolidated Statements of Operations
as a component of income or loss from operations of our OEM
reporting segment.
THE OFFERING
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Common Stock Offered By Us |
Shares of our common stock having an aggregate offering price of up
to $40,000,000. |
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Common Stock Outstanding After
This Offering
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Up to 62,757,412 shares, assuming the sale of up to 28,169,014
shares of our common stock at a price of $1.42 per share, which was
the closing price of our common stock on the NASDAQ Stock Market on
November 21, 2022. The actual number of shares issued will vary
depending on the sales price under this offering. |
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Plan of Distribution |
“At the market” offering that may be made from time to time through
our agent, Piper Sandler. See “Plan of Distribution” on page
17
of this prospectus.
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Use of Proceeds |
We currently intend to use the net proceeds from the sale of
securities offered by this prospectus for working capital and other
general corporate purposes, including expanding our sales and
marketing, capital expenditures, facilities expansion, acquisitions
of complementary business or products, technologies or businesses
and repaying indebtedness we may incur from time to time. See “Use
of Proceeds” on page
14
of this prospectus.
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Risk Factors |
Investing in our common stock involves significant risks. See “Risk
Factors” on page
12
of this prospectus, and under similar headings in other documents
incorporated by reference into this prospectus.
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Symbol on the Nasdaq Stock Market |
“APYX” |
The number of shares of common stock to be outstanding after this
offering is based on 34,588,398 shares of common stock outstanding
as of September 30, 2022 and excludes as of September 30,
2022:
•6,635,409
shares of common stock issuable upon the exercise of outstanding
stock options having a weighted-average exercise price of
approximately $7.13 per share.
In addition, unless we specifically state otherwise, all
information in this prospectus assumes no exercise of outstanding
stock options subsequent to September 30, 2022.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements within the
meaning of Section 27A of the Securities Act regarding our
business, financial condition, results of operations and prospects.
Words such as “expects,” “anticipates,” “intends,” “plans,” “aims,”
“predicts,” “believes,” “seeks,” “estimates,” and similar
expressions or variations of such words are intended to identify
forward-looking statements. However, these are not the exclusive
means of identifying forward-looking statements. Although
forward-looking statements contained in this prospectus reflect our
good faith judgment, such statements can only be based on facts and
factors currently known to us. Consequently, forward-looking
statements are inherently subject to risks and uncertainties, and
actual outcomes may differ materially from the results and outcomes
discussed in the forward-looking statements, including but not
limited to risks, uncertainties and assumptions relating to the
regulatory environment in which the Company is subject to,
including the Company’s ability to gain requisite approvals for its
products from the FDA and other governmental and regulatory bodies,
both domestically and internationally; the impact of the recent FDA
Safety Communication on our business and operations; factors
relating to the effects of the COVID-19 pandemic; sudden or extreme
volatility in commodity prices and availability, including supply
chain disruptions; changes in general economic, business or
demographic conditions or trends; changes in and effects of the
geopolitical environment;
liabilities and costs which the Company may incur from pending or
threatened litigations, claims, disputes or investigations. You
should review the risks and uncertainties referred to in this
prospectus under the heading “Risk
Factors,”
as well as those in our other filings made from time to time with
the SEC. You should not place undue reliance on forward-looking
statements, which speak only as of the date of this prospectus. We
undertake no obligation to update publicly any forward-looking
statements in order to reflect any event or circumstance occurring
after the date of this prospectus or currently unknown facts or
conditions or the occurrence of unanticipated events. In addition,
our past results are not necessarily indicative of future results,
thus, we cannot guarantee future results, levels of activity,
performance or achievements. Factors that could cause actual
results to differ from those discussed in the forward-looking
statements include, but are not limited to:
•changes
in general economic, business or demographic conditions or trends
in the U.S. or throughout the world or changes in the political
environment, including changes in GDP, trade wars, interest rates
and inflation;
•our
ability to conclude a sufficient number of attractive growth
projects, deploy growth capital in amounts consistent with our
objectives in the prosecution of those and achieve targeted
risk-adjusted returns on any growth project, including the
continued commercialization of our Helium Plasma
Technology;
•the
regulatory environment, including our ability to gain requisite
approval from the FDA and other governmental and regulatory bodies,
both domestically and internationally, including the effects of the
recent FDA Medical Device Safety Communication regarding an
emerging safety signal of our products;
•our
ability to estimate compliance costs, comply with any changes
thereto, rates implemented by regulators, and our relationships and
rights under, and contracts with, governmental agencies and
authorities;
•disruptions
or other extraordinary or force majeure events and the ability to
insure against losses resulting from such events or disruptions,
including disruptions caused by COVID-19 or other global
pandemics;
•sudden
or extreme volatility in commodity prices and availability,
including supply chain disruptions;
•changes
in competitive dynamics affecting our business and the medical
device industry as a whole;
•technological
innovations leading to increased competition in the medical device
industry;
•changes
in healthcare policy;
•our
ability to make alternate arrangements to account for any
disruptions or shutdowns that may affect suppliers’ facilities or
the operations upon which our business is dependent;
•continued
aggressive EPA state regulation of Ethylene oxide sterilization
commercial plants resulting in additional plant closures, leading
to a reduced availability of our handpieces, which are commercially
sterilized;
•our
ability to implement operating and internal growth
strategies;
•environmental
risks, including the impact of climate change and weather
conditions;
•the
impact of weather events, including potentially hurricanes,
tornadoes and/or seasonal extremes;
•unplanned
outages and/or failures of technical and mechanical
systems;
•cybersecurity
breaches impacting critical systems or data;
•work
interruptions or other labor stoppages;
RISK FACTORS
Investing in our securities involves certain risks. You should
carefully consider the risk factors contained in Item 1A under the
caption “Risk
Factors”
and elsewhere in our annual report on Form 10-K for the fiscal year
ended December 31, 2021 and in our quarterly report on Form 10-Q
for the fiscal quarter ended September 30, 2022, which are
incorporated into this prospectus by reference, as updated by our
annual or quarterly reports for subsequent fiscal years or fiscal
quarters that we file with the SEC and that are so incorporated.
See “Where
You Can Find More Information”
for information about how to obtain a copy of these documents. You
should also carefully consider the risks and other information that
may be contained in, or incorporated by reference into, any
prospectus supplement relating to specific offerings of
securities.
Each of the referenced risks and uncertainties could adversely
affect our business, operating results and financial condition, as
well as adversely affect the value of an investment in our
securities. Additional risks and uncertainties not known to us or
that we believe are immaterial may also adversely affect our
business, operating results and financial condition and the value
of an investment in our securities.
ADDITIONAL RISKS RELATED TO THIS OFFERING
You may experience dilution.
The offering price per share in this offering may exceed the net
tangible book value per share of our common stock outstanding prior
to this offering. Assuming that an aggregate of 28,169,014 shares
of our common stock are sold at a price of $1.42 per share, the
last reported sale price of our common stock on the NASDAQ Stock
Market on November 21, 2022, for aggregate gross proceeds of $40
million, and after deducting commissions and estimated offering
expenses payable by us, you would experience immediate dilution of
$0.14 per share, representing the difference between our as
adjusted net tangible book value per share as of September 30, 2022
after giving effect to this offering and the assumed offering
price. The exercise of outstanding stock options would result in
further dilution of your investment. See the section entitled
“Dilution”
below for a more detailed illustration of the dilution you would
incur if you participate in this offering. Because the sales of the
shares offered hereby will be made directly into the market or in
negotiated transactions, the prices at which we sell these shares
will vary and these variations may be significant. Purchasers of
the shares we sell,
as well as our existing shareholders, will experience significant
dilution if we sell shares at prices significantly below the price
at which they invested.
You may experience future dilution as a result of future equity
offerings.
In order to raise additional capital, we may in the future offer
additional shares of our common stock or other securities
convertible into or exchangeable for our common stock. We cannot
assure you that we will be able to sell shares or other securities
in any other offering at a price per share that is equal to or
greater than the price per share paid by investors in this
offering, and investors purchasing shares or other securities in
the future could have rights superior to existing stockholders. The
price per share at which we sell additional shares of our common
stock or other securities convertible into or exchangeable for our
common stock in future transactions may be higher or lower than the
price per share in this offering.
Our management might apply the net proceeds from this offering in
ways with which you do not agree and in ways that may impair the
value of your investment.
We currently intend to use the net proceeds from the sale of
securities offered by this prospectus for working capital and other
general corporate purposes, including expanding our sales and
marketing, capital expenditures, facilities expansion, acquisitions
of complementary business or products, technologies or businesses
and repaying indebtedness we may incur from time to time. The
timing and amount of our actual expenditures will be based on many
factors, including cash flows from operations and the anticipated
growth of our business. As a result, our management will have broad
discretion to allocate the net proceeds of the offerings. We might
apply these proceeds in ways with which you do not agree, or in
ways that do not yield a favorable return. If our management
applies these proceeds in a manner that does not yield a
significant return, if any, on our investment of these net
proceeds, it could compromise our ability to pursue our growth
strategy and adversely affect the market price of our common
stock.
It is not possible to predict the actual number of shares we will
sell under the Equity Distribution Agreement or the gross proceeds
resulting from those sales.
Subject to certain limitations in the Equity Distribution Agreement
and compliance with applicable law, we have the discretion to
deliver instructions to Piper Sandler to sell shares of our common
stock at any time throughout the term of the Equity Distribution
Agreement. The number of shares that are sold through Piper Sandler
after our instructions will fluctuate based on a number of factors,
including the market price of our common stock during the sales
period, the limits we set with Piper Sandler in any instructions to
sell shares, and the demand for our common stock during the sales
period. Because the price per share of each share sold will
fluctuate during this offering, it is not currently possible to
predict the number of shares that will be sold or the gross
proceeds to be raised in connection with those sales.
The common stock offered hereby will be sold in “at the market
offerings,” and investors who buy shares at different times will
likely pay different prices.
Investors who purchase shares in this offering at different times
will likely pay different prices, and so may experience different
levels of dilution and different outcomes in their investment
results. We will have discretion, subject to market demand, to vary
the timing, prices, and numbers of shares sold in this offering. In
addition, subject to the final determination by our board of
directors, there is no minimum or maximum sales price for shares to
be sold in this offering. Investors may experience a decline in the
value of the shares they purchase in this offering as a result of
sales made at prices lower than the prices they paid.
Sales of a significant number of shares of our common stock in the
public markets, or the perception that such sales could occur,
could depress the market price of our common stock.
Sales of a significant number of shares of our common stock in the
public markets, or the perception that such sales could occur as a
result of our utilization of our shelf registration statement, the
Equity Distribution Agreement or otherwise could depress the market
price of our common stock and impair our ability to raise capital
through the sale of additional equity securities. We cannot predict
the effect that future sales of our common stock or the market
perception that we are permitted to sell a significant number of
our securities would have on the market price of our common
stock.
USE OF PROCEEDS
We may issue and sell shares of our common stock having aggregate
sales proceeds of up to $40 million from time to time. Because
there is no minimum offering price for the shares that we may offer
from time to time, the actual total public offering amount,
commissions to Piper Sandler and proceeds to us, if any, are not
determinable at this time. There can be no assurance that we will
sell any shares under or fully utilize the Equity Distribution
Agreement with Piper Sandler as a source of financing.
We currently intend to use the net proceeds from the sale of
securities offered by this prospectus for working capital and other
general corporate purposes, including expanding our sales and
marketing, capital expenditures, facilities expansion, acquisitions
of complementary business or products, technologies or businesses
and repaying indebtedness we may incur from time to time. The
timing and amount of our actual expenditures will be based on many
factors, including cash flows from operations and the anticipated
growth of our business. As a result, our management will have broad
discretion to allocate the net proceeds of the
offerings.
DILUTION
If you invest in our common stock in this offering, your ownership
interest will be diluted to the extent of the difference between
the public offering price per share of our common stock and the as
adjusted net tangible book value per share of our common stock
immediately after this offering.
Our net tangible book value as of September 30, 2022 was
approximately $42.0 million or $1.22 per share. Net tangible book
value per share is determined by dividing our total tangible
assets, less total liabilities, by the number of shares of our
common stock outstanding as of September 30, 2022. Dilution with
respect to net tangible book value per share represents the
difference between the amount per share paid by purchasers of
shares of common stock in this offering and the net tangible book
value per share of our common stock immediately after this
offering.
After giving effect to the sale of 28,169,014 shares of our common
stock in this offering at an assumed offering price of $1.42 per
share, the last reported sale price of our common stock on the
NASDAQ Stock Market on November 21, 2022, for aggregate gross
proceeds of $40 million, and after deducting commissions and
offering expenses payable by us, our as adjusted net tangible book
value as of September 30, 2022 would have been approximately $80.6
million, or $1.28 per share. This represents an immediate increase
in net tangible book value of $0.06 per share to existing
stockholders and immediate dilution of $0.14 per share to investors
purchasing our common stock in this offering at the assumed public
offering price. The following table illustrates this dilution on a
per share basis:
|
|
|
|
|
|
|
|
|
Assumed public offering price per share |
|
$ |
1.42 |
|
Net tangible book value per share of as of September 30,
2022 |
$ |
1.22 |
|
|
Increase in net tangible book value per share attributable to this
offering |
$ |
0.06 |
|
|
As adjusted net tangible book value per share as of September 30,
2022, after giving effect to this offering |
|
$ |
1.28 |
|
Dilution per share to investors purchasing our common stock in this
offering |
|
$ |
0.14 |
|
The above discussion and table are based on 34,588,398 shares of
common stock outstanding as of September 30, 2022 and exclude as of
September 30, 2022:
•6,635,409
shares of common stock issuable upon the exercise of outstanding
stock options having a weighted-average exercise price of
approximately $7.13 per share.
In addition, unless we specifically state otherwise, all
information in this prospectus assumes no exercise of outstanding
stock options subsequent to September 30, 2022.
The table above assumes for illustrative purposes that an aggregate
of 28,169,014 shares of our common stock are offered during the
term of the Equity Distribution Agreement with Piper Sandler at a
price of $1.42 per share, the last reported sale price of our
common stock on the NASDAQ Stock Market on November 21, 2022, for
aggregate gross proceeds of $40 million. The shares subject to the
Equity Distribution Agreement with Piper Sandler are being sold
from time to time at various prices.
An increase of $0.35 per share in the price at which the shares are
sold from the assumed offering price of $1.42 per share shown in
the table above, assuming all of our common stock in the aggregate
amount of $40 million during the term of the Equity Distribution
Agreement with Piper Sandler is sold at that price, would increase
our as adjusted net tangible book value per share after the
offering to $1.41 per share and would increase the dilution in net
tangible book value per share to new investors in this offering to
$0.36 per share, after deducting commissions and estimated
aggregate offering expenses payable by us.
A decrease of $0.35 per share in the price at which the shares are
sold from the assumed offering price of $1.42 per share shown in
the table above, assuming all of our common stock in the aggregate
amount of $40 million during the term of the Equity Distribution
Agreement with Piper Sandler is sold at that price, would decrease
our as adjusted net tangible book value per share after the
offering
to $1.12 per share and would result in an increase in net tangible
book value per share to new investors in this offering of $0.05 per
share, after deducting commissions and estimated aggregate offering
expenses payable by us. This information is supplied for
illustrative purposes only.
To the extent that outstanding stock options outstanding as of
September 30, 2022 have been or may be exercised or other shares
issued, investors purchasing our common stock in this offering may
experience further dilution. In addition, we may choose to raise
additional capital due to market conditions or strategic
considerations even if we believe we have sufficient funds for our
current or future operating plans. To the extent that additional
capital is raised through the sale of equity, convertible debt
securities or other securities exchangeable for common stock, the
issuance of these securities could result in further dilution to
our stockholders.
DESCRIPTION OF CAPITAL STOCK
The following is only a summary of the material terms of our common
stock and preferred stock,
together with the additional information we may include in any
applicable prospectus supplements.
Because it is only a summary, it does not contain all the
information that may be important to you. Accordingly, you should
carefully read the more detailed provisions of our certificate of
incorporation, as amended, and our by-laws, each of which has been
filed with the SEC, as well as applicable provisions of Delaware
law.
Authorized Capitalization
Our authorized capital stock consists of 75,000,000 shares of
Common Stock, par value $0.001 per share, and 10,000,000 shares of
“blank check” Preferred Stock, par value $.001 per share. As of
November 21, 2022, there were 34,597,822 shares of common stock
issued and outstanding, held by approximately 600 stockholders of
record. Since many stockholders choose to hold their shares under
the name of their brokerage firm, we estimate that the actual
number of stockholders was over 3,500.
Common Stock
Holders of shares of common stock are entitled to one vote for each
share on all matters to be voted on by the stockholders, and do not
have cumulative voting rights, subject to the preferences that may
be applicable to any then outstanding shares of preferred stock.
Holders of shares of common stock are entitled to share ratably in
dividends, if any, as may be declared from time to time by the
Board of Directors in its discretion, from funds legally available
therefore. In the event of our liquidation, dissolution or winding
up, holders of our common stock will be entitled to share ratably
in the net assets legally available for distribution to
shareholders after the payment of all of our debts and other
liabilities. Holders of common stock have no preemptive or other
subscription rights, and there are no conversion rights or
redemption with respect to such shares.
Preferred Stock
Our certificate of incorporation, as amended, provides that our
Board of Directors has the authority, without further action by the
stockholders, to issue up to a specified number of shares of
preferred stock in one or more series and to fix the rights,
preferences, privileges and restrictions of this preferred stock,
including dividend rights, conversion rights, voting rights, terms
of redemption, liquidation preferences, sinking fund terms and the
number of shares constituting any series or the designation of a
series, without further vote or action by the
stockholders.
If we issue preferred stock, our Board of Directors would fix the
rights, preferences, privileges and restrictions of the preferred
stock of each series in a Certificate of Designations relating to
that series. We will incorporate by reference as an exhibit to the
registration statement that includes this prospectus or as an
exhibit to a current report on Form 8-K, the form of any
Certificate of Designations that describes the terms of the series
of preferred stock we are offering before the issuance of the
related series of preferred stock. This description will
include:
•the
title and stated value;
•the
number of shares we are offering;
•the
liquidation preference per share;
•the
purchase price;
•the
dividend rate, period and payment date and method of calculation
for dividends;
•whether
dividends will be cumulative or non-cumulative and, if cumulative,
the date from which dividends will accumulate;
•the
procedures for any auction and remarketing, if any;
•the
provisions for a sinking fund, if any;
•the
provisions for redemption or repurchase, if applicable, and any
restrictions on our ability to exercise those redemption and
repurchase rights;
•any
listing of the preferred stock on any securities exchange or
market;
•whether
the preferred stock will be convertible into our common stock, and,
if applicable, the conversion price, or how it will be calculated,
and the conversion period;
•voting
rights, if any, of the preferred stock;
•preemption
rights, if any;
•restrictions
on transfer, sale or other assignment, if any;
•a
discussion of any material or special United States federal income
tax considerations applicable to the preferred stock;
•the
relative ranking and preferences of the preferred stock as to
dividend rights and rights if we liquidate, dissolve or wind up our
affairs;
•any
limitations on issuance of any class or series of preferred stock
ranking senior to or on a parity with the series of preferred stock
as to dividend rights and rights if we liquidate, dissolve or wind
up our affairs; and
•any
other specific terms, preferences, rights or limitations of, or
restrictions on, the preferred stock.
The issuance of preferred stock, whether pursuant to this offering
or otherwise, could adversely affect the voting power, conversion
or other rights of holders of our common stock. Preferred stock
could be issued quickly with terms designed to delay or prevent a
change in control of our company or make removal of management more
difficult. Additionally, the issuance of preferred stock may have
the effect of decreasing the market price of our common
stock.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is Manhattan
Transfer Registrar Company. Its telephone number is
877-645-8691.
Listing
Our common stock trades on the NASDAQ Stock Market LLC under the
symbol “APYX.”
Delaware General Corporation Law Section 203
As a corporation organized under the laws of the State of Delaware,
we are subject to Section 203 of the Delaware General Corporation
Law (the “DGCL”) which restricts certain business combinations
between us and an “interested stockholder” (in general, a
stockholder owning 15% or more of our outstanding voting stock) or
its affiliates or associates for a period of three years following
the date on which the stockholder becomes an “interested
stockholder.” The restrictions do not apply if (i) prior to an
interested stockholder becoming such, the board of directors
approves either the business combination or the transaction in
which the stockholder becomes an interested stockholder, (ii) upon
consummation of the transaction in which any person becomes an
interested stockholder, such interested stockholder owns at least
85% of our voting stock outstanding at the time the transaction
commences (excluding shares owned by certain employee stock
ownership plans and persons who are both directors and officers of
us) or (iii) on or subsequent to the date an interested stockholder
becomes such, the business combination is both approved by the
board of directors and authorized at an annual or special meeting
of our stockholders, not by written consent, by the affirmative
vote of at least 66-2/3% of the outstanding voting stock not owned
by the interested stockholder.
Limitations of Liability and Disclosure of SEC Position On
Indemnification for Securities Act Liabilities
As permitted under Delaware law, we have adopted provisions in our
certificate of incorporation that limit or eliminate the personal
liability of our directors for a breach of their fiduciary duty of
care as a director. The duty of care generally requires that, when
acting on behalf of the corporation, directors exercise an informed
business judgment based on all material information reasonably
available to them. Consequently, a director will not be personally
liable to us or our stockholders for monetary damages or breach of
fiduciary duty as a director, except for liability
for:
•Any
breach of the director’s duty of loyalty to us or our
stockholders;
•Any
act or omission not in good faith or that involves intentional
misconduct or a knowing violation of law;
•Any
act related to unlawful stock repurchases, redemptions or other
distributions or payment of dividends under DGCL Section 174;
or
•Any
transaction from which the director derived an improper personal
benefit.
These limitations of liability do not affect the availability of
equitable remedies such as injunctive relief or rescission. Our
certificate of incorporation also authorizes us to indemnify our
officers, directors and other agents to the fullest extent
permitted under Delaware law.
Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the company pursuant to the foregoing
provisions, or otherwise, we have been informed that in the opinion
of the SEC such indemnification is against public policy as
expressed in the Securities Act of 1933 and is, therefore,
unenforceable.
PLAN OF DISTRIBUTION
We have entered into the Equity Distribution Agreement with Piper
Sandler, as our sales agent, pursuant to which we may issue and
sell from time to time shares of our common stock having an
aggregate offering price of up to $40,000,000 through Piper
Sandler.
This prospectus only relates to up to $40,000,000 of shares of our
common stock that we may issue and sell from time to time under the
Equity Distribution Agreement. We will be required to file another
prospectus or prospectus supplement in the event we want to offer
more than $40,000,000 in shares of our common stock in accordance
with the terms of the Equity Distribution Agreement.
Piper Sandler will use commercially reasonable efforts to sell on
our behalf all shares of our common stock requested to be sold by
us, consistent with its normal trading and sales practices, under
the terms and subject to the conditions set forth in the Equity
Distribution Agreement. We may instruct Piper Sandler not to sell
our common stock if the sales cannot be effected at or above the
price designated by us in any instruction. We or Piper Sandler may
suspend the offering of our common stock upon proper notice and
subject to other conditions, as further described in the Equity
Distribution Agreement.
Upon delivery of a placement notice, and subject to our
instructions in that notice and the terms and conditions of the
Equity Distribution Agreement generally, Piper Sandler may sell our
common stock by any method permitted by law that is deemed to be an
“at the market offering” as defined in Rule 415(a)(4) promulgated
under the Securities Act, including sales made directly on or
through the NASDAQ Stock Market or on any other existing trading
market for our common stock. Piper Sandler will provide written
confirmation to us no later than the opening of trading on the
NASDAQ Stock Market on the day following each day in which our
common stock is sold under the Equity Distribution Agreement. Each
such confirmation will include the number of shares of our common
stock sold on such day, the volume-weighted average price of the
shares sold, the net proceeds to us and the compensation payable by
us to Piper Sandler in connection with such sales.
We will pay Piper Sandler commissions for its services in acting as
sales agent in the sale of our common stock. Piper Sandler will be
entitled to compensation in an amount equal to 3.0% of the gross
sales price of all common stock sold through it as sales agent
under the Equity Distribution Agreement. We have also agreed to
reimburse Piper Sandler for the out-of-pocket reasonable fees and
disbursements of its legal counsel, in an amount not to exceed
$125,000, in connection with the establishment of this
at-the-market offering program. In accordance with Financial
Industry Regulatory Authority, Inc. Rule 5110, these reimbursed
fees and expenses are deemed sales compensation in connection with
this offering. We estimate that the total expenses for this
offering, excluding compensation and reimbursements payable to
Piper Sandler under the terms of the Equity Distribution Agreement,
will be approximately $126,000.
Settlement for sales of our common stock will occur on the second
business day following the date on which any such sales are made,
or on some other date that is agreed upon by us and Piper Sandler
in connection with a particular transaction, in return for payment
of the net proceeds to us. There is no arrangement for funds to be
received in an escrow, trust or similar arrangement.
We will report at least quarterly the number of shares of our
common stock sold through Piper Sandler, as sales agent, under the
Equity Distribution Agreement, and the net proceeds to us in
connection with such sales.
Piper Sandler and its affiliates may in the future provide various
investment banking, commercial banking, fiduciary and advisory
services for us for which they may receive, customary fees and
expenses. Piper Sandler and its affiliates may from time to time
engage in other transactions with and perform services for us in
the ordinary course of their business.
In connection with the sale of our common stock on our behalf,
Piper Sandler will be deemed to be an underwriter within the
meaning of the Securities Act, and the compensation paid by us to
Piper Sandler will be deemed to be underwriting commissions or
discounts. We have agreed to indemnify Piper Sandler against
specified liabilities, including liabilities under the Securities
Act, or to contribute to payments that Piper Sandler may be
required to make because of such liabilities.
The offering of our common stock pursuant to the Equity
Distribution Agreement will terminate upon the termination of the
Equity Distribution Agreement. The Equity Distribution Agreement
may be terminated by Piper Sandler or us at any time upon specified
prior written notice.
Any summary of provisions of the Equity Distribution Agreement
above does not purport to be a complete statement of the Equity
Distribution Agreement terms and conditions. A copy of the Equity
Distribution Agreement is filed as an exhibit to the registration
statement of which this prospectus forms a part.
LEGAL MATTERS
The validity of the common stock offered by this prospectus will be
passed upon by Ruskin Moscou Faltischek, P.C., Uniondale, New York.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., New York, New
York, is counsel for Piper Sandler in connection with this
offering.
EXPERTS
The consolidated financial statements of Apyx Medical Corporation
as of December 31, 2021 and 2020 and for each of the years in the
two-year period ended December 31, 2021 incorporated in this
Prospectus by reference from the Apyx Medical Corporation Annual
Report on Form 10-K for the year ended December 31, 2021 have been
audited by RSM US LLP, an independent registered public accounting
firm, as stated in their report thereon, incorporated herein by
reference, and have been incorporated in this Prospectus and
Registration Statement in reliance upon such report and upon the
authority of such firm as experts in accounting and
auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and
other information with the SEC. Our SEC filings are available to
the public over the Internet at the SEC’s website at
www.sec.gov.
The registration statement and the documents referred to below
under “Incorporation
of Certain Information by Reference”
are also available on our website at http://www.Apyxmedical.com. We
have not incorporated by reference into this prospectus the
information on our website, and you should not consider it to be a
part of this prospectus.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to incorporate by reference the information we
file with it, which means that we can disclose important
information to you by referring you to those documents. The
information incorporated by reference is considered to be a part of
this prospectus, and information in documents that we file later
with the SEC will automatically update and supersede the
information in this prospectus. We incorporate by reference into
this prospectus the documents listed below and any future filings
we make with the SEC under Section 13(a), 13(c) 14 or 15(d) of the
Securities Exchange Act of 1934, as amended, until this offering is
completed and all securities are sold or until the sale of
securities pursuant to this prospectus is terminated by
us.
This prospectus is part of a registration statement on Form S-3 we
have filed with the SEC. This prospectus does not contain all of
the information in the registration statement. We have omitted
certain parts of the registration statement as permitted under the
rules and regulations of the SEC. You may view and inspect the
registration statement and exhibits on the SEC’s website (see above
“Where
You Can Find More Information”).
•Our
Annual Report on Form 10-K for the year ended December 31, 2021
filed with the SEC on March 17, 2022.
•Our
Quarterly Report on Form 10-Q for the fiscal period ended March 31,
2022 filed with the SEC on May 12, 2022.
•Our
Quarterly Report on Form 10-Q for the fiscal period ended June 30,
2022 filed with the SEC on August 11, 2022.
•Our
Quarterly Report on Form 10-Q for the fiscal period ended September
30, 2022 filed with the SEC on November 10, 2022.
•Our
Current Reports on Forms 8-K and 8-K/A filed with the SEC on March
14, 2022, March 21, 2022, April 4, 2022, May 26, 2022, June 13,
2022, July 18, 2022, and August 17, 2022.
•Description
of the Registrant’s Common Stock contained in the Registration
Statement on Form 8-A/A filed with the SEC on December 31, 2018,
including any amendment or report filed for the purpose of updating
such description.
Upon request, Apyx will provide, free of charge, to each person to
whom a prospectus is delivered, including a beneficial owner, a
copy of any or all information that has been incorporated by
reference in the prospectus but not delivered with the prospectus.
Any such request may be made orally or in writing to Apyx Medical
Corporation, 5115 Ulmerton Road, Clearwater, Florida 33760,
Attention: Tara Semb, Chief Financial Officer, Tel. No.: (727)
803-8615.
Up to $40,000,000
Common Stock
APYX MEDICAL CORPORATION
Piper Sandler
__________, 2022
PART
II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The following table sets forth the estimated costs and expenses of
the sales and distribution of the securities being registered, all
of which are being borne by us.
|
|
|
|
|
|
SEC registration fee |
$11,020.00 |
Estimated accounting fees and expenses |
40,000.00 |
Estimated legal fees and expenses |
75,000.00 |
Miscellaneous expenses |
* |
|
|
Total |
$126,020.00 |
* The amount of securities and number of offerings are
indeterminable and expenses cannot be estimated at this
time.
ITEM 15.
INDEMNIFICATION OF DIRECTORS AND OFFICERS.
Section 145 of the Delaware General Corporation Law (“DGCL”)
states:
(a) A corporation shall have the power to indemnify any person who
was or is a party or is threatened to be made a party to any
threatened, pending or completed action, suit or proceeding,
whether civil, criminal, administrative or investigative (other
than an action arising by or in the right of the corporation) by
reason of the fact that the person is or was a director, officer,
employee or agent of the corporation, or is or was serving at the
request of the corporation as a director, officer, employee or
agent of another corporation, partnership, joint venture, trust or
other enterprise, against expenses (including attorneys’ fees),
judgments, fines and amounts paid in settlement actually and
reasonably incurred by the person in connection with such action,
suit or proceeding if the person acted in good faith and in a
manner the person reasonably believed to be in or not opposed to
the best interests of the corporation, and, with respect to any
criminal action or proceeding, had no reasonable cause to believe
the person’s conduct was unlawful. The termination of any action,
suit or proceeding by judgment, order, settlement, conviction, or
upon a plea of nolo contendere or its equivalent, shall not, of
itself, create a presumption that the person did not act in good
faith and in a manner which the person reasonably believed to be in
or not opposed to the best interests of the corporation, and, with
respect to any criminal action or proceeding, had reasonable cause
to believe that the person’s conduct was unlawful.
(b) A corporation shall have power to indemnify any person who was
or is a party or is threatened to be made a party to any
threatened, pending or completed action or suit by or in the right
of the corporation to procure a judgment in its favor by reason of
the fact that the person is or was a director, officer, employee or
agent of the corporation, or is or was serving at the request of
the corporation as a director, officer, employee or agent of
another corporation, partnership, joint venture, trust, or other
enterprise against expenses (including attorneys’ fees) actually
and reasonably incurred by the person in connection with the
defense or settlement of such action or suit if the person acted in
good faith and in a manner the person reasonably believed to be in
or not opposed to the best interests of the corporation and except
that no indemnification shall be made in respect of any claim,
issue or matter as to which such person shall have been adjudged to
be liable to the corporation unless and only to the extent that the
Court of Chancery or the court in which such action or suit was
brought shall determine upon application that, despite the
adjudication of liability but in view of all the circumstances of
the case, such person is fairly and reasonably entitled to
indemnity for such expense which the Court of Chancery or such
other court shall deem proper.
As permitted under the DGCL, we have adopted provisions in our
Certificate of Incorporation, as amended, and By-laws that limit or
eliminate the personal liability of our directors for a breach of
their fiduciary duty of care as a director. The duty of care
generally requires that, when acting on behalf of the corporation,
directors exercise an informed business judgment based on all
material information reasonably available to them. Consequently, a
director will not be personally liable to us or our stockholders
for monetary damages or breach of fiduciary duty as a director,
except for liability for:
•Any
breach of the director’s duty of loyalty to us or our
stockholders;
•Any
act or omission not in good faith or that involves intentional
misconduct or a knowing violation of law;
•Any
act related to unlawful stock repurchases, redemptions or other
distributions or payment of dividends under DGCL Section 174;
or
•Any
transaction from which the director derived an improper personal
benefit.
These limitations of liability do not affect the availability of
equitable remedies such as injunctive relief or rescission. Our
Certificate of Incorporation, as amended, also authorizes us to
indemnify our officers, directors and other agents to the fullest
extent permitted under Delaware law. We have purchased insurance to
insure (i) our directors and officers against changes from actions
and claims incurred in the course of their duties, and (ii) our
Company against expenses incurred in defending lawsuits arising
from certain alleged acts of our directors and
officers.
Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the company pursuant to the foregoing
provisions, or otherwise, we have been informed that in the opinion
of the SEC such indemnification is against public policy as
expressed in the Securities Act of 1933 and is, therefore,
unenforceable.
ITEM 16. EXHIBITS
The following documents are filed as part of this Registration
Statement:
|
|
|
|
|
|
|
|
|
1.1* |
|
Form of Underwriting Agreement |
1.2** |
|
|
3.1 |
|
|
3.2 |
|
|
3.3 |
|
|
3.4 |
|
|
3.5 |
|
|
4.1** |
|
|
4.2* |
|
Form of Common Stock Warrant Agreement and Warrant
Certificate |
4.3* |
|
Form of Preferred Stock Warrant Agreement and Warrant
Certificate |
4.4* |
|
Form of Unit Agreement |
5.1** |
|
|
23.1** |
|
|
23.2** |
|
|
24.1** |
|
|
107.1** |
|
|
* To
be filed by amendment or by a report filed under the Securities
Exchange Act of 1934, as amended, and incorporated herein by
reference, if applicable.
**Previously filed.
ITEM 17. UNDERTAKINGS
The undersigned registrant hereby undertakes:
(1)To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration
statement:
(i)To
include any prospectus required by section 10(a)(3) of the
Securities Act of 1933;
(ii)To
reflect in the prospectus any facts or events arising after the
effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing,
any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that
which was registered) and any deviation from the low or high end of
the estimated maximum offering range may be reflected in the form
of prospectus filed with the SEC pursuant to Rule 424(b) if, in the
aggregate, the changes in volume and price represent no more than a
20% change in the maximum aggregate offering price set forth in the
“Calculation of Registration Fee” table in the effective
registration statement.
(iii)To
include any material information with respect to the plan of
distribution not previously disclosed in the registration statement
or any material change to such information in the registration
statement;
Provided, however,
that paragraphs (i), (ii) and (iii) above do not apply if the
information required to be included in a post-effective amendment
by those paragraphs is contained in reports filed with or furnished
to the SEC by the registrant pursuant to section 13 or section
15(d) of the Securities Exchange Act of 1934 that are incorporated
by reference in the registration statement, or is contained in a
form of prospectus filed pursuant to Rule 424(b) that is part of
the registration statement.
(2)That,
for the purpose of determining any liability under
the Securities Act of 1933, each such post-effective
amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of
such securities at that time shall be deemed to be the initial bona
fide offering thereof.
(3)To
remove from registration by means of a post-effective amendment any
of the securities being registered which remain unsold at the
termination of the offering.
(4)For
the purpose of determining liability under the Securities Act of
1933 to any purchaser:
(i)Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall
be deemed to be part of the registration statement as of the date
the filed prospectus was deemed part of and included in the
registration statement; and
(ii)Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5),
or (b)(7) as part of a registration statement in reliance on Rule
430B relating to an offering made pursuant to Rule 415(a)(1)(i),
(vii), or (x) for the purpose of providing the information
required by section 10(a) of the Securities Act of 1933 shall be
deemed to be part of and included in the registration statement as
of the earlier of the date such form of prospectus is first used
after effectiveness or the date of the first contract of sale of
securities in the offering described in the prospectus. As provided
in Rule 430B, for liability purposes of the issuer and any person
that is at that date an underwriter, such date shall be deemed to
be a new effective date of the registration statement relating to
the securities in the registration statement to which that
prospectus relates, and the offering of such securities at that
time shall be deemed to be the initial bona fide offering thereof.
Provided, however, that no statement made in a registration
statement or prospectus that is part of the registration statement
or made in a document incorporated or deemed incorporated by
reference into the registration statement or prospectus that is
part of the registration statement will, as to a purchaser with a
time of contract of sale prior to such effective date, supersede or
modify any statement that was made in the registration statement or
prospectus that was part of the registration statement or made in
any such document immediately prior to such effective
date.
(5)For
the purpose of determining liability of the registrant under the
Securities Act of 1933 to any purchaser in the initial distribution
of the securities: The undersigned registrant undertakes that in a
primary offering of securities of the undersigned registrant
pursuant to this registration statement, regardless of the
underwriting method used to sell the securities to the purchaser,
if the securities are offered or sold to such purchaser by means of
any of the following communications, the undersigned registrant
will be a seller to the purchaser and will be considered to offer
or sell such securities to such purchaser:
(i)Any
preliminary prospectus or prospectus of the undersigned registrant
relating to the offering required to be filed pursuant to Rule
424;
(ii)Any
free writing prospectus relating to the offering prepared by or on
behalf of the undersigned registrant or used or referred to by the
undersigned registrant;
(iii)The
portion of any other free writing prospectus relating to the
offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the
undersigned registrant; and
(iv)Any
other communication that is an offer in the offering made by the
undersigned registrant to the purchaser.
(6) For purposes of determining any
liability under the Securities Act of 1933, each filing of the
registrant’s annual report pursuant to Section 13(a) or 15(d)
of the Securities Exchange Act of 1934 (and, where applicable, each
filing of an employee benefit plan’s annual report pursuant to
Section 15(d) of the Securities Exchange Act of 1934) that is
incorporated by reference in the registration statement shall be
deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering
thereof.
(7) Insofar as indemnification for
liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the
registrant pursuant to the foregoing provisions or otherwise, the
registrant has been advised that in the opinion of the Securities
and Exchange Commission such indemnification is against public
policy as expressed in the Securities Act of 1933 and is therefore
unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the registrant
of expenses incurred or paid by a director, officer or controlling
person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in
the Securities Act of 1933, and will be governed by the final
adjudication of such issue.
(8) That, for purposes of determining any
liability under the Securities Act of 1933:
(i) The information omitted from the form
of prospectus filed as part of this registration statement in
reliance upon Rule 430A and contained in a form of prospectus filed
by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h)
under the Securities Act shall be deemed to be part of this
registration statement as of the time it was declared effective;
and
(ii) Each post-effective amendment that
contains a form of prospectus shall be deemed to be a new
registration statement relating to the securities offered therein,
and the offering of such securities at that time shall be deemed to
be the initial bona fide offering thereof.
(9) To file an application for the purpose
of determining the eligibility of the trustee to act under
subsection (a) of Section 310 of the Trust Indenture Act
in accordance with the rules and regulations prescribed by the SEC
under Section 305(b)(2) of the Act.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
Registrant certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form S-3/A and has
duly caused this Registration Statement to be signed on its behalf
by the undersigned, thereunto duly authorized in the City of
Clearwater, State of Florida on December 2, 2022.
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Apyx Medical Corporation |
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By: |
/s/ Charles D. Goodwin II |
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Charles D. Goodwin II |
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Chief Executive Officer and Director |
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Pursuant to the requirements of the Securities Act of 1933, this
Pre-Effective Amendment No.1 to the Registration Statement has been
signed by the following persons in the capacities and on the dates
indicated.
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Name |
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Title |
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Date |
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Directors: |
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/s/ CHARLES D. GOODWIN II |
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Chief Executive Officer and Director |
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December 2, 2022 |
Charles D. Goodwin II |
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* |
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Chairman of the Board |
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December 2, 2022 |
Andrew Makrides |
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Chief Financial Officer (Principal Accounting Officer and Principal
Financial Officer), Treasurer and Secretary |
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December 2, 2022 |
Tara Semb |
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Director |
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December 2, 2022 |
John Andres |
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Director |
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December 2, 2022 |
Lawrence J. Waldman |
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Director |
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December 2, 2022 |
Michael Geraghty |
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Director |
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December 2, 2022 |
Craig A. Swandal |
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Director |
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December 2, 2022 |
Minnie Baylor-Henry |
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Director |
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December 2, 2022 |
Wendy Levine |
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*By:
/s/ Charles D. Goodwin II
Charles D. Goodwin II
Attorney-in-Fact
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