Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
(Mark One)
Commission File Number: 001-33216
SONOMA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its
charter)
645 Molly Lane, Suite 150
Woodstock, Georgia30189
(Address of principal executive offices) (Zip
Code)
(800)759-9305
(Registrant’s telephone number, including
area code)
Securities registered pursuant to Section 12(b)
of the Act:
Common Stock, $0.0001 par value SNOA The Nasdaq Stock Market LLC
Securities registered pursuant to Section 12(g)
of the Act:
None.
Indicate by check mark if
the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No☒
Indicate by check mark if
the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐No☒
Indicate by check mark whether
the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days. Yes☒
No ☐
Indicate by check mark whether
the registrant has submitted electronically every Interactive Data file required to be submitted pursuant to Rule 405 of Regulation S-T
(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit
such files). Yes☒ No ☐
Indicate by check mark whether
the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging
growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting
company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated Filer ☒ Smaller reporting company ☒
Emerging growth company ☐
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. ☐
Indicate by check mark whether
the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control
over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that
prepared or issued its audit report. ☐
Indicate by check mark whether
the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐No☒
The aggregate market value
of the voting and non-voting common stock held by non-affiliates of the registrant on September 30, 2021, was $16,658,750 based on
a total of 2,985,439 non-affiliate shares of the registrant’s common stock held by non-affiliates on September 30, 2021, at the
closing price of $5.58 per share, as reported on the Nasdaq Capital Market.
There were 3,100,937 shares
of the registrant’s common stock issued and outstanding on July 11, 2022.
DOCUMENTS INCORPORATED BY
REFERENCE
Items 10 (as to directors
and Section 16(a) Beneficial Ownership Reporting Compliance), 11, 12, 13 and 14 of Part III will incorporate by reference information
from the registrant’s proxy statement to be filed with the Securities and Exchange Commission in connection with the solicitation
of proxies for the registrant’s 2021 annual meeting of stockholders.
TABLE OF CONTENTS
Page
PART I
ITEM 1. Business 1
ITEM 1A. Risk Factors 21
ITEM 2. Properties 36
ITEM 3. Legal Proceedings 36
ITEM 4. Mine Safety Disclosures (Not applicable.) 36
PART II
ITEM 6. Selected Financial Data 37
ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk 43
ITEM 8. Consolidated Financial Statements and Supplementary Data 44
ITEM 9A. Controls and Procedures 45
ITEM 9B. Other Information 46
PART III
ITEM 10. Directors, Executive Officers and Corporate Governance 47
ITEM 11. Executive Compensation 48
ITEM 14. Principal Accounting Fees and Services 48
PART IV
ITEM 15. Exhibits, Financial Statement Schedules 49
Signatures 53
i
PART I
This report includes “forward-looking
statements.” The words “may,” “will,” “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “plan,” “aim,” “seek,” “should,” “likely,”
and similar expressions as they relate to us or our management are intended to identify these forward-looking statements. All statements
by Sonoma regarding expected financial position, revenues, cash flows and other operating results, business strategy, legal proceedings
and similar matters are forward-looking statements. Our expectations expressed or implied in these forward-looking statements may not
turn out to be correct. Our results could be materially different from our expectations because of various risks, including the risks
discussed in this report under “Part I — Item 1A — Risk Factors.” Any forward-looking statement
speaks only as of the date as of which such statement is made, and, except as required by law, we undertake no obligation to update any
forward-looking statement to reflect events or circumstances, including unanticipated events, after the date as of which such statement
was made.
ITEM 1. Business
Corporate Information
We originally incorporated as Micromed Laboratories,
Inc. in 1999 under the laws of the State of California. We changed our name to Oculus Innovative Sciences, Inc. in 2001. In December 2006
we reincorporated under the laws of the State of Delaware, and in December 2016 we changed our name to Sonoma Pharmaceuticals, Inc.
In June 2020, we relocated our principal executive
offices from 1129 N. McDowell Blvd., Petaluma, California, 94954 to 645 Molly Lane, Suite 150, Woodstock, Georgia, 30189. We have two
active wholly-owned subsidiaries: Oculus Technologies of Mexico, S.A. de C.V., and Sonoma Pharmaceuticals Netherlands, B.V. Our fiscal
year end is March 31. Our corporate telephone number is (800) 759-9305. Our websites are www.sonomapharma.com and www.sonomapharma.eu.
The websites and any information contained therein or connected thereto is not intended to be incorporated into this report.
Overview
We are a global healthcare leader for developing
and producing stabilized hypochlorous acid, or HOCl, products for a wide range of applications, including wound care, animal health care,
eye care, oral care and dermatological conditions. Our products reduce infections, itch, pain, scarring and harmful inflammatory responses
in a safe and effective manner. In-vitro and clinical studies of HOCl show it to have impressive antipruritic, antimicrobial, antiviral
and anti-inflammatory properties. Our stabilized HOCl immediately relieves itch and pain, kills pathogens and breaks down biofilm, does
not sting or irritate skin and oxygenates the cells in the area treated, assisting the body in its natural healing process. We sell our
products either directly or via partners in 54 countries worldwide.
Business Update
After two years of restructuring the Company,
we are now focused on growing our revenues while maintaining costs. During 2021, we built out our Boulder, Colorado office with new sales
and marketing staff. We are beginning to see growth in the U.S. market with new customer and distributor relationships while concurrently
building on organic growth from existing customers. We have also focused on introducing new products into multiple markets around the
world and increasing our regulatory reach by seeking new approvals and clearances.
Some of our recent business updates
include:
We continue to invest in research and development,
both in the U.S. and internationally, for our core performance-stabilized hypochlorous acid, or HOCl, technology. We have an active pipeline
of products and are engaged in on-going studies either independently or with partners to increase applications of our technology. Additionally,
we continue to seek new regulatory clearances to expand potential markets we can sell our products into.
The COVID-19 pandemic still affects our business
and presents new challenges. Whereas in the beginning of the pandemic, we had to manage closures and shelter-in-place orders, we now face
higher shipping costs, shipping delays and higher labor costs driven by inflation and a surplus of opportunities for job seekers.
As we move into our new fiscal year, our path
forward will consist of looking for U.S. and international distribution partners, developing new products to bring to market and expanding
further into U.S. over-the-counter markets.
Business Channels
Our core market differentiation is based on
being the leading developer and producer of stabilized hypochlorous acid, or HOCl, solutions. Unlike many of our competitors, we
have been in business for over 20 years, and in that time we have developed significant scientific knowledge of how best to develop
and manufacture HOCl products backed by decades of studies and data collection. HOCl is known to be among the safest and
most-effective ways to relieve itch, inflammation and burns while stimulating natural healing through increased oxygenation and
eliminating persistent microorganisms and biofilms.
We sell our products into many markets both in
the U.S. and internationally. In international markets, we ship products to 54 countries. Our core strategy is to work with partners both
in the United States and around the world to market and distribute our products. In some cases, we market and sell our own products.
Dermatology
Sonoma Dermatology has developed unique, differentiated,
prescription-strength and safe dermatologic products that support paths to healing among various key dermatologic conditions. Our products
are primarily targeted at the treatment of acne, the management of scars and atopic dermatitis. We are strategically focused on introducing
innovative new products that are supported by human clinical data with applications that address specific dermatological procedures currently
in demand. In addition, we look for markets where we can provide effective product line extensions and pricing to new product families.
In the United States, we partner with EMC Pharma,
LLC to sell our prescription products for an initial term of five years, subject to meeting minimum purchase and other requirements. Pursuant
to our agreement with EMC Pharma, we manufacture products for EMC Pharma and EMC Pharma markets, sells and distributes them to patients
and customers.
On September
28, 2021, we launched a new over-the-counter product, Regenacyn® Advanced Scar Gel, which is clinically proven to improve the overall
appearance of scars while reducing pain, itch, redness, and inflammation. Additionally, on the same day, we launched Regenacyn® Plus,
a prescription-strength scar gel which is available as an office-dispense product through physician offices. Our consumer products are
available through Amazon.com, our website and U.S.-based distributors.
We sell dermatology products in Europe, Asia,
and Brazil through a distributor network. In these international markets, we have a network of partners, ranging from country specific
distributors to large pharmaceutical companies to full-service sales and marketing companies. We work with our international partners
to create products they can market in their home country. Some products we develop and manufacture are private label while others use
branding we have already developed. We have created or co-developed a wide range of products for international markets using our core
HOCl technology.
First Aid and Wound Care
Our HOCl-based wound care products are intended
for the treatment of acute and chronic wounds as well as first- and second-degree burns. They work by first removing foreign material and
debris from the skin surface and moistening the skin, thereby improving wound healing. Second, our HOCl products assist in the wound healing
process through their antimicrobial properties by removing microorganisms. Since HOCl is an important constituent of our innate immune
system and is formed and released by the macrophages during phagocytosis, it is advantageous to other wound-irrigation and antiseptic
solutions as highly organized cell structures such as human tissue can tolerate the action of our wound care solution while single-celled
microorganisms cannot. Due to its unique chemistry, our wound treatment solution is much more stable than similar products on the market
and therefore maintains much higher levels of hypochlorous acid over its shelf life.
In the United States, we sell our wound care products
directly to hospitals, physicians, nurses, and other healthcare practitioners and indirectly through several non-exclusive distribution
arrangements.
To respond to market demand for our HOCl technology-based
products, we launched our first direct to consumer over-the-counter product in the United States in February 2021. Microcyn® OTC Wound
and Skin Cleanser is formulated for home use without prescription to help manage and cleanse wounds, minor cuts, and burns, including
sunburns and other skin irritations. Microcyn® OTC Wound and Skin Cleanser is available without prescription through Sonoma’s
online store.
In Europe, we rely on agreements with country-specific
distributors for the sale of our wound care products under a variety of brand names into 27 countries, including Austria, Belgium, Croatia,
Italy, the Netherlands, Germany, Greece, Hungary, the Czech Republic, Spain, Norway, Switzerland, Poland, Portugal, Slovenia, the Slovak
Republic, Finland, Denmark, Montenegro and Serbia.
In March 2021, we received approval to market
and use our HOCl products as biocides under Article 95 of the European Biocidal Products Regulation in France, Germany and Portugal. The
approval applies to our products MucoClynsTM for human hygiene to be marketed and commercialized by us, MicrocynAH® for animal
heath marketed and commercialized through our partner, Petagon Limited, and MicroSafe for disinfectant use to be marketed and commercialized
through our partner, MicroSafe Group Dubai.
Eye Care
Our prescription product
AcuicynTM is an antimicrobial prescription solution for the treatment of blepharitis and the daily hygiene of eyelids and lashes
and helps manage red, itchy, crusty and inflamed eyes. It is strong enough to kill the bacteria that causes discomfort, fast enough to
provide near instant relief, and gentle enough to use as often as needed. In the United States, our partner EMC Pharma is selling our
prescription-based eye care product through its distribution network.
On September 28, 2021,
we launched Ocucyn Eyelid & Eyelash Cleanser, which is sold directly to consumers on Amazon.com. Ocucyn
Eyelid & Eyelash Cleanser, designed for everyday use, is a safe, gentle, and effective solution for good eyelid & eyelash hygiene.
In international markets
we rely on a network of distribution partners to sell our eye products. On May 19, 2020, we entered into an expanded license and distribution
agreement with our existing partner, Brill International S.L. for our Microdacyn60® Eye Care HOCl-based product. Under the license
and distribution agreement, Brill has the right to market and distribute our eye care product under the private label OcudoxTM in
Italy, Germany, Spain, Portugal, France, and the United Kingdom for a period of 10 years, subject to meeting annual minimum sales quantities.
In return, Brill will pay us a one-time fee, and the agreed upon supply prices. In parts of Asia, Dyamed Biotech markets our eye product
under the private label Ocucyn.
Oral, Dental and Nasal Care
We sell
a variety of oral, dental, and nasal products around the world.
In late 2020 we launched two HOCl-based products
in the dental, head and neck markets and launched Endocyn®, a biocompatible root canal irrigant. In August 2021, we launched OroGenix
Oral Hygiene Rinse. In the U.S., we sell our dental products through U.S.-based distributors.
Internationally, our product Microdacyn60®
Oral Care treats mouth and throat infections and thrush. Microdacyn60 solution assists in reducing inflammation, pain, soothing cough
relief and does not contain any harmful chemicals. It does not stain teeth, is non-irritating, non-sensitizing, has no contraindications
and is ready for use with no mixing or dilution. In New Zealand and Australia, our partner Te Arai BioFarma Ltd. markets our oral product
under their label Oracyn® Oral Care. Our partner, Dyamed Biotech, expects to launch Oracyn® Oral Care in parts of Asia this year.
On January 18, 2022, we partnered with Anlicare International to seek regulatory clearances for our dental and oral products in China
and Macau.
Our international nasal care product SinudoxTM
based on our HOCl technology is a solution intended for nasal irrigation. Sinudox Hypotonic Nasal Hygiene clears and cleans a blocked
nose, stuffy nose and sinuses by ancillary ingredients that may have a local antimicrobial effect. Sinudox is sold through Amazon in Europe.
In New Zealand and Australia, our partner Te Arai markets our nasal product under their label Nasocyn® Nasal Care.
Animal Health Care
MicrocynAH® is a HOCl-based topical product
that cleans, debrides and treats a wide spectrum of animal wounds and infections. It is intended for the safe and rapid treatment of a
variety of animal afflictions including cuts, burns, lacerations, rashes, hot spots, rain rot, post-surgical sites, pink eye symptoms
and wounds to the outer ear of any animal.
For our animal health products sold in the U.S.
and Canada, we partnered with Manna Pro Products, LLC to bring relief to pets and peace of mind to their owners. Manna Pro distributes
non-prescription products to national pet-store retail chains, farm animal specialty stores, in the United States and Canada, such as
Chewy.com, PetSmart, Tractor Supply, Cabela’s, PetExpress, and Bass Pro Shops. Additionally, we recently expanded our animal health
product offerings by adding a MicrocynAH line for felines at PetSmart.
For the
Asian and European markets, on May 20, 2019, we partnered with Petagon, Limited, an international importer and distributor of quality
pet food and products for an initial term of five years. We supply Petagon with all MicrocynAH products sold by Petagon. On August 3,
2020, Petagon received a license from the People’s Republic of China for the import of veterinary drug products manufactured by
us. This is the highest classification Petagon and Sonoma can receive for animal health products in China.
Surface Disinfectants
In-vitro and clinical studies of HOCl show it
to have impressive antipruritic, antimicrobial, antiviral and anti-inflammatory properties. HOCl has been formulated as a disinfectant
and sanitizer solution for our partner MicroSafe Group, Dubai, and is sold in numerous countries. It is designed to be used to spray in
aerosol format to areas and environments which are suspected to serve as a breeding ground for the spread of infectious disease, likely
to result in epidemics or pandemics. The medical-grade surface disinfectant solution is used in hospitals worldwide to keep doctors and
patients protected and safe. In May 2020, Nanocyn® Disinfectant & Sanitizer, received approval to be entered into the Australian
Register of Therapeutic Goods, or ARTG, as well as in Canada, for use against the coronavirus SARS-CoV-2, or COVID-19. Nanocyn has also
met the stringent environmental health and social/ethical criteria of Good Environmental Choice Australia, or GECA, becoming one of the
very few eco-certified, all-natural disinfectant solutions in Australia.
Through our partner MicroSafe Group DMCC, Dubai,
we sell hard surface disinfectant products into the U.S., Europe, the Middle East and Australia.
On July 31, 2021, we granted MicroSafe the non-exclusive
right to sell and distribute Nanocyn in the United States provided that MicroSafe secure U.S. EPA approval. In April of 2022, MicroSafe
secured the EPA approval for Nanocyn® Disinfectant & Sanitizer, meaning that it can now be sold in the United States as a surface
disinfectant, and it was subsequently added to the EPA’s list N for use against COVID-19. We intend to build upon this ground-breaking
approval by securing further approvals of this nature. Nanocyn® is a hospital-grade disinfectant and manufactured by us using our
patented HOCl technology. Nanocyn® is currently sold by MicroSafe in Europe, the Middle East and Australia.
Employees
As of July 11, 2022, we employed
a total of 11 full-time employees in the United States, and one full-time employee in the Netherlands.
Additionally, we had 165 employees in Mexico, all of which were contracted through an employment agency. We are not a party to any
collective bargaining agreements. We believe relations with employees are very good.
Products
Our products are all classified as medical devices and categorized
as prescription products, over-the-counter, or OTC, and office dispense. Below are some of our key products that we either sell through
our own efforts or through partnership agreements.
Dermatology
In the United States our prescription product
offerings are EpicynTM Antimicrobial Facial Cleanser, LevicynTM Antimicrobial Dermal Spray, LevicynTM Antipruritic Gel,
LevicynTM Antipruritic Spray Gel, CelacynTM Scar Management Gel and SebudermTM Topical Gel. We also have our office dispense
products LasercynTM Dermal Spray, LasercynTM Post Procedure Gel and RegenacynTM Advanced Scar Management. We also offer
Regenacyn Advanced Scar Gel for OTC purchase.
Internationally, we offer GramaDermTM Hydrogel and Solution Combo
Pack to assist in the treatment of topical mild to moderate acne, EpicynTM Scar Management Hydrogel and PediacynTM Atopic Dermatitis
Hydrogel.
Celacyn® Scar Management Gel
LevicynTM Antipruritic Dermal Spray, Antipruritic Spray Gel, and
Antipruritic Gel
LasercynTM
Wound Care
In the United States we offer Microcyn® wound and skin care both
as an OTC, and prescription product.
Microcyn® Wound Care Management
Eye, Nasal and Oral Care
AcuicynTM Eyelid and Eyelash Hygiene
Microdacyn60® Oral Care
Animal Health Care
In the United States and internationally, our HOCl-based MicrocynAH®
line offers topical solutions designed to relieve the common symptoms of hot spots, scratches, skin rashes post-surgical sites and irritated
animal skin and promote expedited healing for all animals.
Surface Disinfectants
Through our partner MicroSafe DMCC, Dubai, we sell Nanocyn®. Nanocyn
is a hospital-grade disinfectant indicated to sterilize hard surfaces by spraying directly onto the surface, for medical devices by submerging
the device in Nanocyn, and also for fumigation into the air.
When fumigated, Nanocyn has demonstrated the ability to kill a wide
range of airborne pathogens and significantly reduce the spread of infectious disease.
Research and Development
Research and development expense consists primarily
of expenses for clinical studies, personnel, regulatory services and supplies. For the years ended March 31, 2022 and 2021, research and
development expense amounted to $125,000 and $555,000, respectively. A small percentage of these expenses were borne by our customers.
Manufacturing and Packaging
Through June 23, 2020, we manufactured products
at facilities in Petaluma, California and Zapopan, Mexico. On June 24, 2020, we transitioned all of our manufacturing to Zapopan, Mexico
and closed our Petaluma facility. We have developed a manufacturing process and conduct quality assurance testing on each production batch
in accordance with current U.S., Mexican and international Current Good Manufacturing Practices. Both facilities are required to meet
and maintain regulatory standards applicable to the manufacture of pharmaceutical and medical device products. Our Mexican facilities
are certified and comply with U.S. Current Good Manufacturing Practices, Quality Systems Regulations for medical devices, and International
Organization for Standardization, or ISO, guidelines. Our Mexican facility has been approved by the Ministry of Health and is also ISO
13485 certified.
Our machines are tested regularly, which is part
of a validation protocol mandated by U.S., Mexican and international Current Good Manufacturing Practices, Quality Systems Regulation,
and ISO requirements. This validation is designed to ensure that the final product is consistently manufactured in accordance with product
specifications at all manufacturing sites. Certain materials and components used in manufacturing are proprietary to Sonoma. All other
raw materials and supplies utilized in the manufacturing process of our products are available from various third-party suppliers in quantities
adequate to meet our needs.
We believe we own a sufficient factory space and
equipment to produce an adequate amount of product to meet anticipated future requirements for at least the next two years. With expansion
into new geographic markets, we may establish additional manufacturing facilities to better serve those new markets.
U.S. Regulatory Approvals and Clearances
To date, we have obtained 21 U.S. Food and Drug
Administration, or FDA, clearances permitting the sale of products as medical devices for Section 510(k) of the Federal Food, Drug and
Cosmetic Act in the United States.
Outside the United States, we sell products for
dermatological and advanced tissue care with a European Conformity marking, Conformité Européenne, or CE. On April 9, 2020,
we received an updated EC certificate covering 39 products in 54 countries with various approvals in Brazil, China, Southeast Asia, South
Korea, India, Australia, New Zealand, and the Middle East.
The following table summarizes
our current material regulatory approvals and clearances by brand.
Brand Approval Type Summary Indication
HOCl-based Products:
Significant Customers
We rely on certain key customers for a
significant portion of revenues. In the U.S., our key customers are EMC Pharma, LLC with which we partnered in March 2021 to sell
our prescription dermatology and eye care products and Manna Pro, our partner for our animal health care products. Our wound
care products are purchased by hospitals, physicians, nurses, and other healthcare practitioners from us directly. At March 31,
2022, one customer represented 20% of our net accounts receivable balance, one customer represented 15% of our net accounts
receivable balance, and one customer represented 14% of our net accounts receivable balance. At March 31, 2021, one customer
represented 17% of our net accounts receivable balance, one customer represented 16% of our net accounts receivable balance, and one
customer represented 14% of our net accounts receivable balance. For the year ended March 31, 2022, one customer represented 10%,
one customer represented 17%, and one customer represented 21% of net revenues. For the year ended March 31, 2021, one customer
represented 32%, and one customer represented 15% of net revenues.
Intellectual Property
Our success depends in part on an ability to obtain
and maintain proprietary protection for product technology and know-how, to operate without infringing proprietary rights of others, and
to prevent others from infringing on our proprietary rights. We seek to protect a proprietary position by, among other methods, filing,
when possible, U.S. and foreign patent applications relating to our technology, inventions and improvements that are important to the
business. We have patented certain aspects of our HOCl technology in the United States and worldwide. We also rely on trade secrets, know-how,
continuing technological innovation, and in-licensing opportunities to develop and maintain a proprietary position.
Although we work diligently to protect proprietary
technology, there are no assurances that any patent will be issued from currently pending patent applications or from future patent applications.
The scope of any patent protection may not exclude competitors or provide competitive advantages, and any patent may not be held valid
if subsequently challenged, and others may claim rights in or ownership of patents and proprietary rights. Furthermore, others may develop
products similar to ours and may duplicate any of the products or design around patents.
We have also filed for trademark protection for
marks used with products in each of the following regions: United States, Europe, Canada, certain countries in Central and South America,
including Mexico and Brazil, certain countries in the Middle East and certain countries in Asia, including Japan, China, Hong Kong, the
Republic of Korea, India and Australia. In addition to patents and trademarks, we rely on trade secret and other intellectual property
laws, nondisclosure agreements and other measures to protect intellectual property rights. We believe that in order to have a competitive
advantage, we must develop and maintain the proprietary aspects of technologies. Employees, consultants and advisors are required to execute
confidentiality agreements in connection with their employment, consulting or advisory relationships. Employees, consultants and advisors
with whom we expect to work with are also required to disclose and assign to us all inventions made in the course of a working relationship
with them, while using intellectual property or which relate to our business. Despite any measures taken to protect our intellectual property,
unauthorized parties may attempt to copy aspects of the products or to wrongfully obtain or use information that regarded as proprietary.
Competition
We compete globally across five main channels:
dermatology, eye, nasal and oral care, wound and acute care, animal health and surface disinfectants with our HOCl technology.
Dermatology
Our dermatology products are at the forefront
of HOCl-based solutions, a safe and highly effective active ingredient designed to relieve itching, burning and inflammation and acts
as a highly effective antimicrobial agent. We believe no other solutions on the market provide the same patient benefits at the levels
of safety and cost. Our HOCl-based solutions face significant competition in the United States from prescription products including corticosteroids,
topical steroids and topical antibiotics. Our opportunity as an adjunct to these steroids is based on the insight that many doctors and
patients limit steroid and antibiotic use due to potential side effects. These side effects include bacterial resistance, stinging, burning
and inflammation for topical antibiotics and stretch marks, easy bruising, tearing of the skin and, to a lesser extent, enlarged of blood
vessels for topical steroids. Our HOCl-based products are safe, non-toxic and have shown few side effects in clinical studies.
Wound and Acute Care Markets
Similar to our dermatology products, our HOCl-based
wound and acute care solutions provide improved efficacy at lower costs than traditional acute care products. Our HOCl-based solutions
compete with topical anti-infectives and antibiotics, as well as some advanced wound technologies, such as skin substitutes, growth factors
and delayed release silver-based dressings. Our opportunity in this space relative to antibiotics is based on the insight that competing
antibiotic solutions may have resistance-building properties.
Factors Affecting Competitive Position
While some other companies are able to produce
small molecule, HOCl-based formulations, based on our research, their products may become unstable after a relatively short period of
time or have large ranges of effectiveness. We believe our HOCl-based solutions are among the most stable therapeutics available.
Some of our competitors in the dermatology, wound
care, eye, nasal and oral care, animal health care and surface disinfectant markets enjoy several competitive advantages. These include:
· greater name recognition;
· established distribution networks;
Government Regulation
Government authorities in the United States, at
the federal, state and local levels, and foreign countries extensively regulate, among other things, the research, development, testing,
manufacture, labeling, promotion, advertising, distribution, sampling, marketing, and import and export of pharmaceutical products, biologics
and medical devices. All of our products in development will require regulatory approval or clearance by government agencies prior to
commercialization. In particular, human therapeutic products are subject to rigorous pre-clinical and clinical trials and other approval
procedures of the FDA and similar regulatory authorities in foreign countries. Various federal, state, local and foreign statutes and
regulations also govern testing, manufacturing, safety, labeling, storage, distribution and record-keeping related to such products and
their marketing. The process of obtaining these approvals and clearances, and the subsequent process of maintaining substantial compliance
with appropriate federal, state, local, and foreign statutes and regulations, require the expenditure of substantial time and financial
resources. In addition, statutes, rules, regulations and policies may change and new legislation or regulations may be issued that could
delay such approvals.
Medical Device Regulation
To date, we have received 21 510(k) clearances
for use of products as medical devices in tissue care management, such as cleaning, debridement, lubricating, moistening and dressing,
including for acute and chronic wounds, and in dermatology applications. Any future product candidates or new applications classified
as medical devices will require clearance by the FDA.
Medical devices are subject to FDA clearance and
extensive regulation under the Federal Food Drug and Cosmetic Act. Under the Federal Food Drug and Cosmetic Act, medical devices are classified
into one of three classes: Class I, Class II or Class III. The classification of a device into one of these three classes generally depends
on the degree of risk associated with the medical device and the extent of control needed to ensure safety and effectiveness. Devices
may also be designated unclassified. Unclassified devices are legally marketed pre-amendment devices for which a classification regulation
has yet to be finalized and for which a pre-market approval is not required.
Class I devices are devices for which safety and
effectiveness can be assured by adherence to a set of general controls. These general controls include compliance with the applicable
portions of the FDA’s Quality System Regulation, which sets forth good manufacturing practice requirements; facility registration,
device listing and product reporting of adverse medical events; truthful and non-misleading labeling; and promotion of the device only
for its cleared or approved intended uses. Class II devices are also subject to these general controls, and any other special controls
as deemed necessary by the FDA to ensure the safety and effectiveness of the device. Review and clearance by the FDA for these devices
is typically accomplished through the 510(k) pre-market notification procedure. When 510(k) clearance is sought, a sponsor must submit
a pre-market notification demonstrating that the proposed device is substantially equivalent to a legally marketed device. If the FDA
agrees that the proposed device is substantially equivalent to the predicate device, then 510(k) clearance to market will be granted.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would
constitute a major change in its intended use, requires a new 510(k) clearance or could require a pre-market approval.
Clinical trials are almost always required to
support a pre-market approval application and are sometimes required for a 510(k) pre-market notification. These trials generally require
submission of an application for an investigational device exemption. An investigational device exemption must be supported by pre-clinical
data, such as animal and laboratory testing results, which show that the device is safe to test in humans and that the study protocols
are scientifically sound. The FDA must approve an investigational device exemption, in advance, for a specified number of patients, unless
the product is deemed a non-significant risk device and is eligible for more abbreviated investigational device exemption requirements.
Both before and after a medical device is commercially
distributed, manufacturers and marketers of the device have ongoing responsibilities under FDA regulations. The FDA reviews design and
manufacturing practices, labeling and record keeping, and manufacturers’ required reports of adverse experiences and other information
to identify potential problems with marketed medical devices. Device manufacturers are subject to periodic and unannounced inspection
by the FDA for compliance with the Quality System Regulation, which sets forth the Current Good Manufacturing Practice requirements that
govern the methods used in, and the facilities and controls used for the design, manufacture, packaging, servicing, labeling, storage,
installation and distribution of all finished medical devices intended for human use.
FDA regulations prohibit the advertising and promotion
of a medical device for any use outside the scope of a 510(k) clearance or pre-market approval or for unsupported safety or effectiveness
claims. Although the FDA does not regulate physicians’ practice of medicine, the FDA does regulate manufacturer communications with
respect to off-label use.
If the FDA finds that a manufacturer has failed
to comply with FDA laws and regulations or that a medical device is ineffective or poses an unreasonable health risk, it can institute
or seek a wide variety of enforcement actions and remedies, ranging from a public warning letter to more severe actions such as:
· imposing fines, injunctions and civil penalties
· requiring a recall or seizure of products
· refusing requests for 510(k) clearance or pre-market approval of new products
· withdrawing 510(k) clearance or pre-market approval approvals already granted
· criminal prosecution
The FDA also has the authority to require a company
to repair, replace, or refund the cost of any medical device.
The FDA also administers certain controls over
the export of medical devices from the United States, as international sales of medical devices that have not received FDA clearance are
subject to FDA export requirements. Additionally, each foreign country subjects such medical devices to its own regulatory requirements.
In the European Union, there is a single regulatory approval process and approval is represented by the presence of a CE marking.
Other Regulation in the United States
The Physician Payments Sunshine Act
The Physician Payments Sunshine Act signed into
law in 2010 as part of the Affordable Care Act requires manufacturers of medical devices, drugs, biologicals, and medical supplies to
track and report certain payments made to and transfers of value provided to physicians and teaching hospitals as well as to report certain
ownership and investment interests held by physicians and their immediate family members. These manufacturers must report annually to
the Center for Medicare & Medicaid Services any direct or indirect payments and transfers of value of $10 or more, or annual aggregate
of $100 or more, made to physicians or to a third party at the request of or on behalf of a physician, including dentists. Payment includes:
consulting fees, compensation for services other than consulting, honoraria, gifts, entertainment, food, travel (including the specified
destinations), education, research, charitable contribution, royalty or license, current or prospective ownership or investment interest,
direct compensation for serving as faculty or as a speaker for a medical education program, grants, any other nature of the payment, or
other transfer of value. Manufacturers face monetary penalties for non-compliance. Certain payments related to research must be reported
separately. Product samples intended for patient use need not be reported.
Health Care Coverage and Reimbursement by Third-Party
Payors
Commercial success in marketing and selling products
depends, in part, on the availability of adequate coverage and reimbursement from third-party health care payors, such as government and
private health insurers and managed care organizations. Third-party payors are increasingly challenging the pricing of medical products
and services. Government and private sector initiatives to limit the growth of health care costs, including price regulation, competitive
pricing, and managed-care arrangements, are continuing in many countries where we do business, including the United States. These changes
are causing the marketplace to be more cost-conscious and focused on the delivery of more cost-effective medical products. Government
programs, including Medicare and Medicaid, private health care insurance companies, and managed-care plans control costs by limiting coverage
and the amount of reimbursement for particular procedures or treatments. This has created an increasing level of price sensitivity among
customers for our products. Some third-party payors also require that a favorable coverage determination be made for new or innovative
medical devices or therapies before they will provide reimbursement of those medical devices or therapies. Even though a new medical product
may have been cleared or approved for commercial distribution, we may find limited demand for the product until adequate coverage and
reimbursement have been obtained from governmental and other third-party payors.
Fraud and Abuse Laws
In the United States, we are subject to various
federal and state laws pertaining to healthcare fraud and abuse, which, among other things, prohibit the offer or acceptance of remuneration
intended to induce or in exchange for the purchase of products or services reimbursed under a federal healthcare program and the submission
of false or fraudulent claims with the government. These laws include the federal Anti-Kickback Statute, the False Claims Act and comparable
state laws. These laws regulate the activities of entities involved in the healthcare industry, such as Sonoma, by limiting the kinds
of financial arrangements such entities may have with healthcare providers who use or recommend the use of medical products, including,
for example, sales and marketing programs, advisory boards and research and educational grants. In addition, in order to ensure that healthcare
entities comply with healthcare laws, the Office of Inspector General of the U.S. Department of Health and Human Services recommends
that healthcare entities institute effective compliance programs. To assist in the development of effective compliance programs, the Office
of Inspector General has issued model Compliance Program Guidance, materials for a variety of healthcare entities which, among other things,
identify practices to avoid that may implicate the federal Anti-Kickback Statute and other relevant laws and describes elements of an
effective compliance program. While compliance with the Compliance Program Guidance materials is voluntary, a California law requires
pharmaceutical and devices manufacturers to initiate compliance programs that incorporate the Compliance Program Guidance and the July
2002 Pharmaceuticals Research and Manufacturers of America Code on Interactions with Healthcare Professionals.
Due to the scope and breadth of the provisions
of some of these laws, it is possible that some of our practices might be challenged by the government under one or more of these laws
in the future. Violations of these laws, which are discussed more fully below, can lead to civil and criminal penalties, damages, imprisonment,
fines, exclusion from participation in Medicare, Medicaid and other federal health care programs, and the curtailment or restructuring
of operations. Any such violations could have a material adverse effect on our business, financial condition, results of operations or
cash flows.
Anti-Kickback Laws
Our operations are subject to federal and state
anti-kickback laws. The federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, receiving, offering or
providing remuneration directly or indirectly to induce either the referral of an individual for a good or service reimbursed under a
federal healthcare program, or the furnishing, recommending, or arranging of a good or service, for which payment may be made under a
federal healthcare program, such as Medicare or Medicaid. The definition of “remuneration” has been broadly interpreted to
include anything of value, including such items as gifts, discounts, the furnishing of supplies or equipment, waiver of co-payments, and
providing anything at less than its fair market value. Because the Anti-Kickback Statute makes illegal a wide variety of common, even
beneficial, business arrangements, the Office of Inspector General was tasked with issuing regulations, commonly known as “safe
harbors,” that describe arrangements where the risk of illegal remuneration is minimal. As long as all of the requirements of a
particular safe harbor are strictly met, the entity engaging in that activity will not be prosecuted under the federal Anti-Kickback Statute.
The failure of a transaction or arrangement to fit precisely within one or more safe harbors does not necessarily mean that it is illegal
or that prosecution will be pursued. However, business arrangements that do not fully satisfy an applicable safe harbor may result in
increased scrutiny by government enforcement authorities, such as the Office of Inspector General. Our agreements to pay compensation
to our advisory board members and physicians who provide other services for we may be subject to challenge to the extent they do not fall
within relevant safe harbors under state and federal anti-kickback laws. In addition, many states have adopted laws similar to the federal
Anti-Kickback Statute, which apply to the referral of patients for health care services reimbursed by Medicaid, and some have adopted
such laws with respect to private insurance. Violations of the Anti-Kickback Statute are subject to significant fines and penalties and
may lead to a company being excluded from participating in federal health care programs.
False Claims Laws
The federal False Claims Act prohibits knowingly
filing a false claim, knowingly causing the filing of a false claim, or knowingly using false statements to obtain payment from the federal
government. Certain violations of the Anti-Kickback Statute constitute per se violations of the False Claims Act. Under the False Claims
Act, such suits are known as “qui tam” actions. Individuals may file suit on behalf of the government and share in any amounts
received by the government pursuant to a settlement. In addition, certain states have enacted laws modeled after the federal False Claims
Act under the Deficit Reduction Act of 2005, where the federal government created financial incentives for states to enact false claims
laws consistent with the federal False Claims Act. As more states enact such laws, we expect the number of qui tam lawsuits to increase.
Qui tam actions have increased significantly in recent years, causing greater numbers of healthcare companies to have to defend false
claims actions, pay fines or be excluded from Medicare, Medicaid or other federal or state government healthcare programs as a result
of investigations arising out of such actions.
HIPAA
Two federal crimes were created under the Health
Insurance Portability and Accountability Act of 1996, or HIPAA: healthcare fraud and false statements relating to healthcare matters.
The healthcare fraud statute prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including
private payors. The false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or
making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits,
items or services.
Health Information Privacy and Security
Individually, identifiable health information
is subject to an array of federal and state regulation. Federal rules promulgated pursuant to HIPAA regulate the use and disclosure of
health information by “covered entities.” Covered entities include individual and institutional health care providers from
which we may receive individually identifiable health information. These regulations govern, among other things, the use and disclosure
of health information for research purposes, and require the covered entity to obtain the written authorization of the individual before
using or disclosing health information for research. Failure of the covered entity to obtain such authorization could subject the covered
entity to civil and criminal penalties. We may experience delays and complex negotiations in dealing with each entity’s differing
interpretation of the regulations and what is required for compliance. Also, where our customers or contractors are covered entities,
including hospitals, universities, physicians or clinics, we may be required by the HIPAA regulations to enter into “business associate”
agreements that subject the company to certain privacy and security requirements. In addition, many states have laws that apply to the
use and disclosure of health information, and these laws could also affect the manner in which we conduct research and other aspects of
business. Such state laws are not preempted by the federal privacy law when such laws afford greater privacy protection to the individual
than the federal law. While activities to assure compliance with health information privacy laws are a routine business practice, we are
unable to predict the extent to which resources may be diverted in the event of an investigation or enforcement action with respect to
such laws.
Foreign Regulation
Whether or not we obtain FDA approval for a product,
approval of a product by the applicable regulatory authorities of foreign countries must be obtained before clinical trials or marketing
of the product in those countries can begin. The approval process varies from country to country, and the time may be longer or shorter
than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement
also vary greatly from country to country. Although governed by the applicable country, clinical trials conducted outside of the United
States typically are administered under a three-phase sequential process similar to that discussed above for medical devices.
European Union Regulation
Medical Device Regulation
Our products are classified as medical devices
in the European Union. In order to sell medical device products within the European Union, we are required to comply with the requirements
of the Medical Devices Directive, and its national implementations, including affixing CE markings on products. The CE marking indicates
a product’s compliance with EU legislation and so enables the sale of products throughout the European Economic Area, or the EEA,
comprising the 28 Member States of the EU and European Free Trade Association, or EFTA, countries Iceland, Norway, and Liechtenstein.
In order to comply with the Medical Devices Directive, we must meet certain requirements relating to the safety and performance of products
and, prior to marketing products, we must successfully undergo verification of products’ regulatory compliance, or conformity assessment.
On May 26, 2017, the new Medical Devices Directive
became effective in the EEA, becoming fully applicable after a transition period of three years, on May 26, 2020. Under the new Medical
Devices Directive, certain devices will be classified in higher classes, new devices will become classified, and certain new obligations
are imposed on manufacturers and distributors. Manufacturers will be required to engage a medical device expert and carry insurance for
possible liability claims. In addition, the pre-market approval and post-market surveillance requirements were enhanced. The European
Database for Medical Devices, or Eudamed, will hold and publish information on medical devices collected from the European Commission
and the national authorities.
Medical devices are divided into three regulatory
classes: Class I, Class IIB and Class III. The nature of the conformity assessment procedures depends on the regulatory
class of the product. In order to comply with the examination, we completed, among other things, a risk analysis and presented clinical
data, which demonstrated that our products met the performance specifications claimed by us, provided sufficient evidence of adequate
assessment of unwanted side effects and demonstrated that the benefits to the patient outweigh the risks associated with the device. We
are subject to continued supervision and are required to report any serious adverse incidents to the appropriate authorities. We are also
required to comply with additional national requirements that are beyond the scope of the Medical Devices Directive.
We received a CE certificate for 39 of our Class
IIB medical devices, which allows us to affix CE markings on these products and sell them in Europe. We may not be able to maintain the
requirements established for CE markings for any or all of our products or be able to produce these products in a timely and profitable
manner while complying with the requirements of the Medical Devices Directive and other regulatory requirements.
European Good Manufacturing Process
In the European Union, the manufacture of pharmaceutical
products and clinical trial supplies is subject to good manufacturing practice as set forth in the relevant laws and guidelines. Compliance
with good manufacturing practice is generally assessed by the competent regulatory authorities. They may conduct inspections of relevant
facilities, and review manufacturing procedures, operating systems and personnel qualifications. In addition to obtaining approval for
each product, in many cases each drug manufacturing facility must be approved. Further inspections may occur over the life of the product.
Mexican Regulation
The Ministry of Health is the authority in charge
of sanitary controls in Mexico. Sanitary controls are a group of practices related to the orientation, education, testing, verification
and application of security measures and sanctions exercised by the Ministry of Health. The Ministry of Health is responsible for the
issuance of Official Mexican Standards and specifications for drugs subject to the provisions of the General Health Law, which govern