Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) January 10, 2024

SONOMA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-33216	68-0423298
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	Identification No.)

5445 Conestoga Court, Suite 150

Boulder, CO 80301

(Address of principal executive offices)

(Zip Code)

(800) 759-9305

(Registrant’s telephone number, including area code)

Not applicable.

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common Stock	SNOA	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 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. ☐

Item 7.01

Regulation FD Disclosure.

Attached is the updated investor presentation of Sonoma Pharmaceuticals, Inc. and its affiliates (the “Company”). The presentation materials are furnished hereto as Exhibit 99.1.

Except for historical information herein, matters set forth in this report are forward-looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of the Company.

These forward-looking statements are identified by the use of words such as “will,” “develop,” “project,” “expect,” and “expand,” among others. Forward-looking statements in this report are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to meet the Company’s cash needs, fund further development, as well as uncertainties relative to the recent pandemic and economic development, varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission. The Company disclaims any obligation to update these forward-looking statements, except as required by law.

Item 9.01

Financial Statements and Exhibits.

Exhibit Number		Description
99.1†		Investor Presentation as of January 10, 2024.
104		Cover Page Interactive Data File (formatted in Inline XBRL in Exhibit 101).

†

The information filed as Exhibit 99.1 to this Current Report on Form 8-K is being furnished in accordance with Item 7.01 and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities imposed by that Section. Such information shall not be incorporated by reference into any registration statement or other document or filing under the Securities Act of 1933, as amended, except as may be expressly set forth in a specific filing.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	SONOMA PHARMACEUTICALS, INC.


Date: January 10, 2024	By:	/s/ Amy Trombly
	Name: Title:	Amy Trombly Chief Executive Officer

Exhibit 99.1

Sonoma Pharmaceuticals, Inc. Investor Presentation January 2024

Legal Disclaimers INVESTOR PRESENTATION This communication is for informational purposes only. The information contained herein does not purport to be all - inclusive. T he data contained herein is derived from various internal and external sources. No representation is made as to the reasonableness of the assum pti ons made within or the accuracy or completeness of any information contained herein. Any data on past performance is no indication as to future performance. Sonoma Pharmaceuticals, Inc. and its subsidiaries (“Sonoma” or, the “Company”) assumes no obligation to update t he information in this communication. This presentation is not an offer to buy or the solicitation of an offer to sell Sonoma securities. FORWARD - LOOKING STATEMENTS Except for historical information herein, matters set forth in this presentation are forward - looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology pro gress and future financial performance of Sonoma Pharmaceuticals, Inc. and its subsidiaries. These forward - looking statements are identified by the use of words such as “believe,” “achieve,” and “expect,” among other s. Forward - looking statements in this presentation are subject to certain risks and uncertainties inherent in the Company’s business that could cau se actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be suff ici ent to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in act ual patient settings, the Company will not have sufficient capital to implement its business plan, invalidated or circumvented by its competitors, the ava ilable market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more tar get ed markets, revenues will not be sufficient to fund further development and clinical studies, as well as uncertainties relative to varyin g p roduct formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks d eta iled from time to time in the Company’s filings with the Securities and Exchange Commission. The Company disclaims any obligation to update the se forward - looking statements, except as required by law. TRADEMARKS AND INTELLECTUAL PROPERTY All trademarks, service marks, and trade names of the Company and its subsidiaries or affiliates used herein are trademarks, ser vice marks, or registered trademarks of the Company as noted herein. Any other product, company names, or logos mentioned herein are the tra dem arks and/or intellectual property of their respective owners. 2

Sonoma Pharmaceuticals is a global healthcare leader for developing and producing stabilized hypochlorous acid ( HOCl ) products for a wide range of applications, including dermatology, wound care, eye care, nasal care, oral care, podiatry, animal health and non - toxic disinfectants. Sonoma’s products are clinically proven to reduce infection, itch, pain, scarring, and harmful inflammatory responses safely and without damaging healthy tissue. In - vitro and clinical studies of HOCl show it to have impressive antipruritic, antimicrobial, antiviral and anti - inflammatory properties. Sonoma’s stabilized HOCl 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. Sonoma’s products are sold either directly or via partners in 55 countries worldwide and the company actively seeks new distribution partners. About Sonoma 3

Over 20 years of experience developing and manufacturing HOCl products, over 100 research articles, papers and clinical and case studies, over 50 active U.S. and international patents, and continual product innovation Hypochlorous Acid Industry Leader 21 U.S. FDA clearances as 510(k) medical devices, CE marks for over 39 products, and extensive worldwide regulatory clearances Millions of patients treated worldwide without a single report of serious adverse effect Focused on billion - dollar markets in Rx and OTC dermatology, wound care, eye, oral and nasal care, podiatry, animal health and non - toxic disinfectants, treating common injuries, infections and irritations Diverse Global Healthcare Business Investment Highlights Robust and diverse international partner network selling into over 55 countries and extensive worldwide regulatory clearances means products can be commercialized faster Pharmaceutical - grade manufacturing capabilities in Mexico lowers COGS and creates opportunities for volume plays 4

Sonoma’s Microcyn ® Technology Patented, Stabilized Triple - Action Topical Technology • A powerful anti - microbial – reduces microbial load, including destruction of biofilms • Anti - inflammatory agent – reduces itch and pain • Anti - pruritic activity • Tissue healing (increased blood/oxygen flow to wound) Unparalleled Safety • No drug - to - drug interaction or contraindications • Millions of patients treated worldwide without a single report of serious adverse effect • 30+ human clinical trials with over 1,500 patients No Mutations or Resistance • Overused antibiotics may cause deadly epidemics such as MRSA Cost Effective • Preventative – reduces hospital/physician visits • Medicare/hospital savings – faster healing reduces hospital stays 5

What is Hypochlorous Acid? During the activation of neutrophils, respiratory bursts generate hydrogen peroxide (H 2 O 2 ) and the activated granule enzyme myeloperoxidase converts H 2 O 2 to hypochlorous acid (HOCl) • Produced by neutrophils in the body as part of its defense mechanism • Highly active against bacterial, viral , and fungal pathogens • Shown to rapidly kill spore - forming and non - spore forming bacteria and have significant activity against biofilms 6

Over 100 research articles and case and clinical studies showcasing both the efficacy and safety of our Microcyn ® technology • Dermodacyn ® Disinfecting solution study on viability of SARS - CoV - 2, see https://www.sciencedirect.com/science/article/pii/S019567012030339X • Endocyn ® study on cellular toxicity, see https://www.sciencedirect.com/science/article/abs/pii/S0099239917310439 • HOCl study evaluating virucidal activity in Vero E6 cells against SARS - CoV - 2, University of Barcelona, 11/27/2020 • Hypochlorous acid gel technology — Its impact on post - procedure treatment and scar prevention, see https://sonomapharma.com/wp - content/uploads/2020/08/Gold_et_al - 2017 - Journal_of_Cosmetic_Dermatology - 003.pdf • Topical stabilized hypochlorous acid: The future gold standard for wound care and scar management in dermatologic and plastic su rgery procedures, see https://sonomapharma.com/wp - content/uploads/2020/08/Topical - Stabilized - HOCL - consensus - article - 2020.pdf • HOCl Article: Optimizing Wound Healing for Procedures – Apr 2018, see https://sonomapharma.com/wp - content/uploads/2018/11/Pracitcal - Derm - HOCl - article - 4 - 7 - 18 - wounds.pdf 7

• 57,153 square foot state - of - the - art facility • ISO 9001, ISO 13485 and cGMP certified • MOH, KFDA, SFDA, KSA, TGA, EN, Biocide and numerous other national listings and approvals • Shipping to over 55 countries • Highly trained staff of 162 employees CUTTING EDGE MANUFACTURING Flexible operations capable of CUSTOM LABELING, SIZING, PACKAGING & DISPENSE MODES High or small volume, large or small batch, delivered in 8 - 12 weeks Currently operating at 30% capacity, with margin of approximately 35% 8

Located in Guadalajara, Mexico Laboratory Packaging Area Labeling Boxing Ready for shipment Warehouse Air Systems Product Water Treatment System Materials Testing Laboratory Manufacturing Facility 9

Robust International Distribution Network OVER 40 GLOBAL PARTNERS generating strong revenues internationally and in the U.S. • Expand presence in new markets by replicating what works in existing markets • Continue to add new distribution partners and grow existing relationships • Continue co - development of innovative new products with partners in the U.S. and internationally • Work with partners to seek new approvals and certifications 10

Continue to introduce new high margin products Manufacturing capabilities can support significant future growth, leading to improved margins overall • Launch new applications of Sonoma’s Microcyn ® technology for consumer - focused products, including in the cosmetic market Growth Strategy • Efficient, flexible and FDA - regulated manufacturing facility currently operating at only 30% capacity Expand Rx and OTC reach in U.S. Invest in R&D to expand commercialization opportunities • Increase sales of dermatology products through the direct dispense model that generates Sonoma’s highest margins • Increase direct - to - consumer marketing in niche markets • Introduce new technology to new markets • Fully commercialize robust pipeline of new products via direct - to - consumer sales or distribution partnerships 11

Sonoma is expanding its partnerships and product offerings in the all - natural skin care and medical spa industries. • The global natural skin care products market size was valued at $6.7 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 6.6% from 2022 to 2030. 1 • The global medical spa market size was valued at $16.4 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 14.97% from 2023 to 2030. 2 o North America dominated the medical spa market with a share of 41.5% in 2022, attributable in part to increasing demand for minimally invasive aesthetic procedures. 3 Sonoma also continues to expands its presence in the global animal health market that was valued at $39.9 billion in 2021 and is expected to witness a compound annual growth rate (CAGR) of 10.0% from 2022 to 2030. 4 New Market Opportunities 1. Grand View Research, Natural Skin Care Products Market Report, 2022 - 2030 , available at https://www.grandviewresearch.com/industry - analysis/natural - skin - care - products - market 2. Grand View Research, Medical Spa Market Size, Share & Growth Analysis Report 2030 , available at https://www.grandviewresearch.com/industry - analysis/medical - spa - market 3. Ibid. 4. Grand View Research, Animal Health Market Size & Share Report, 2022 - 2030 , available at https://www.grandviewresearch.com/industry - analysis/animal - health - market 12

Introduction of new products using our Microcyn ® technology • On January 5 , 2024 , Sonoma entered into an agreement with NovaBay Pharmaceuticals, Inc . for the sale and marketing of Avenova ® - branded products in the European Union, based on Sonoma’s existing eye product Ocudox ® and sold through Sonoma’s established European distribution network . • On June 8 , 2023 , Sonoma announced a new application of its Microcyn ® technology for intraoperative pulse lavage irrigation treatment , which can replace commonly used IV bags in a variety of surgical procedures . It is in trial use by hospitals in Europe and launched in the U . S . in November 2023 . • On April 11 , 2023 , Sonoma launched Podiacyn TM Advanced Everyday Foot Care direct to consumers for over - the - counter use in the United States . Recent Business Developments 13

Expanding commercialization opportunities by investing in R&D • In March 2023 , Sonoma announced new EPA claims for its Nanocyn ® Hospital - Grade Disinfectant f or effective use against MRSA , Salmonella , Norovirus , Poliovirus , and as a fungicide . Nanocyn was previously approved for use against COVID - 19 as well as emerging pathogens including Ebola virus , Mpox , and SARS - CoV - 2 . Nanocyn also received the esteemed Green Seal ® Certification after surpassing a series of rigorous standards that measure environmental health, sustainability and product performance . • Reliefacyn ® Advanced Itch - Burn - Rash - Pain Relief Hydrogel was awarded the N ATIONAL E CZEMA A SSOCIATION S EAL OF A CCEPTANCE TM Recent Business Developments 14

Continuously expanding our distributor network • Entered into a distribution agreement with Daewoong Pharmaceutical Co., Ltd. , one of the largest pharmaceutical companies in South Korea, in January 2023 for the marketing and distribution of Primocyn TM Skin Solution products • Sonoma’s Microcyn ® Rx products, including wound care, prescription dermatology products Celacyn ® and Levicyn ® , and prescription eye care Acuicyn ® , received a Distribution and Pricing Agreement (DAPA) in January 2023 for distribution by the Defense Logistics Agency (DLA), enabling our partner, EMC Pharma, LLC to enter into distribution agreements for these products with federal customers • In April 2023, our partner Te Arai BioFarma Limited launched BabySoothe for diaper rash applications in Taiwan • Our partner Microderm Technologies recently launched Dermodacyn for wound care applications in Thailand • Signed a new partner, TPVN Pharmaceuticals Company Limited , for distribution of Endocyn Root Canal Irrigation Solution in Vietnam • Our partner Brill Pharma SL is now selling Sonoma’s eye care products in Italy, Spain and Portugal and plans to sell in Germany and France next year • Our MicrocynAH ® products are now available through Pets at Home, with over 450 stores across the UK, through our partner Manna Pro Products, LLC Recent Business Developments 15

Management Amy Trombly CEO Amy Trombly is our Chief Executive Officer and also serves on our Board of Directors . She counseled public companies for over two decades in corporate and securities law and mergers and acquisitions, including as the owner and manager of Trombly Business Law, PC . In her earlier career, Ms . Trombly was a Vice President at State Street Bank and Special Counsel at the U . S . Securities and Exchange Commission . Ms . Trombly is a member of the bar in Massachusetts and Colorado . Bruce Thornton COO Bruce Thornton has served as our Chief Operating Officer, Vice President of Global Operations, and US General Manager since 2004 , and currently as Executive Vice President and Chief Operating Officer . He served as Vice President of Operations for Jomed (formerly EndoSonic Corp . ) from January 1999 to September 2003 , and as Vice President of Manufacturing for Volcano Therapeutics, an international medical device company, following its acquisition of Jomed , until March 2004 . Mr . Thornton received a B . S . in Aeronautical Science from Embry - Riddle Aeronautical University and an M . B . A . from National University . He also has served in the US Army . Jerry Dvonch CFO Mr . Dvonch serves as our Interim Chief Financial Officer . He joined us from the SpineCenter Atlanta where he was the controller and Senior Vice President of Finance and Accounting since March 2017 . From March 2016 to April 2016 he was a consultant controller for DS Healthcare Group, Inc . Prior to that he was the director for external reporting and director of finance of NeoGenomics Laboratories from July 2005 to July 2015 . He has over 10 years of experience with SEC reporting . Mr . Dvonch is a licensed Certified Public Accountant in New York . He holds a Master of Business Administration in Finance from the University of Rochester and a Bachelor of Business Administration in Accounting from Niagara University . 16

Key Financial Metrics * dollars in thousands Year Ended Year Ended Six Months Ended Six Months Ended March 31, 2022* March 31, 2023 * September 30, 2022 * (unaudited) September 30, 2023 * (unaudited) $12,628 $13,272 $7,314 $6,158 Total Revenues $3,993 $4,477 $3,182 $2,194 Gross Profit $9,880 $9,047 $4,768 $4,642 Operating Expenses $(5,086) $(5,151) $(1,904) $(2,902) Net Income (Loss) $(5,318) $(3,776) $(1,597) $(1,985) EBITDA loss $7,396 $3,820 $3,351 $2,137 Cash & Cash equivalents $10,611 $10,081 $8,866 $8,277 Working capital $8,697 $7,977 $7,021 $5,675 Shareholders’ Equity 17

Revenue Metrics Revenues by revenue source: Year Ended March 31, Six Months Ended September 30, 2022 2023 2022 2023 $ 9,010 $ 9,426 $ 4,615 $ 4,824 Human Care 3,169 2,500 1,523 1,067 Animal Care 449 1,346 1,176 266 Service and Royalty $ 12,628 $ 13,272 $ 7,314 $ 6,158 Revenues by geographic region: Year Ended March 31, Six Months Ended September 30, 2022 2023 2022 2023 $ 3,807 $ 3,428 $ 1,842 $ 1,396 United States 3,410 4,051 2,012 2,271 Europe 2,350 2,451 1,438 1,208 Asia 2,095 2,383 1,444 747 Latin America 966 959 578 536 Rest of the World $ 12,628 $ 13,272 $ 7,314 $ 6,158 Total * in thousands 18

THANK YOU Sonoma Pharmaceuticals Inc. 5445 Conestoga Court , Suite 150 Boulder , CO 80301 United States of America Phone: 1 - (800) 759.9305 Email: busdev@sonomapharma.com Website: www.sonomapharma.com NASDAQ: SNOA

APPENDIX: Product Portfolio

Diverse Product Portfolio United States Podiacyn Everyday Foot Care Microcyn Rx Skin & Wound Care Regenacyn Scar Gel Epicyn Antimicrobial Facial Cleanser Nanocyn Hospital Grade Disinfectant Levicyn Antimicrobial Dermal Spray Celacyn Scar Management Gel Rejuvacyn Skin Repair Reliefacyn Itch, Burn, Rash & Pain Care Microcyn OTC Wound & Skin Cleanser Ocucyn Eyelid & Eyelash Cleanser Pediacyn Skin Care & First Aid for Children Acuicyn Antimicrobial Eyelid & Eyelash Hygiene 21

U.S. office dispense products exclusively for skin care professionals • Generates highest margins for Sonoma • Focused marketing to med spas and dermatology offices, which can resell products to their clients for a substantial margin 22

U.S. Animal Health Care MicrocynAH ® family of advanced animal healthcare products, safe to use on pets and livestock, and perfect for hot spots, pink eye, scratches, skin rashes and ulcers, cuts, burns, post - surgical sites, irritated skin and lacerations. • Sold in national pet - store retail chains and specialty stores such as Petsmart , Chewy.com , Tractor Supply , Cabela’s and Bass Pro Shops . MicrocynVS® veterinarian - strength animal care for use in vet clinics and animal hospitals. 23

Epicyn ® Dermatology Gramaderm ® Dermatology Pediacyn ® Dermatology Mucoclyns ® Decontamination solution Microdacyn60 ® Oral Care Blocked nose or sinuses Sinudox ® Nasal care Blepharitis treatment Ocudox ® Eye lid solution Exposure to germs and pathogens Mouth and throat infections Keloid or hypertrophic scar Acne treatment Atopic Dermatitis Solutions that work naturally for everybody EU Products Microdacyn60® Wound Care MicrocynAH ® Animal Health Care 24

Direct - to - consumer products available through Shopify, Amazon and Amazon EU U.S. Products EU Products 25

Middle East 26

Gramacyn Kit for Acne Skin Latin America Epicyn Treat Scars Right from the Start Australia and New Zealand 27

Singapore, Malaysia, Thailand, Indonesia Wound Care South Korea BioDerm Biodacyn60 Wound Care Hong K ong Microdacyn60 Oral Care China Microcyn The Philippines M icrodacyn MicrocynAH Asia 28

Cover	Jan. 10, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 10, 2024
Entity File Number	001-33216
Entity Registrant Name	SONOMA PHARMACEUTICALS, INC.
Entity Central Index Key	0001367083
Entity Tax Identification Number	68-0423298
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	5445 Conestoga Court
Entity Address, Address Line Two	Suite 150
Entity Address, City or Town	Boulder
Entity Address, State or Province	CO
Entity Address, Postal Zip Code	80301
City Area Code	(800)
Local Phone Number	759-9305
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	SNOA
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false