UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
☒ ANNUAL REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended December 31, 2024
Commission
File Number: 001-41615
Mangoceuticals, Inc.
(Exact name of registrant as specified in its charter)
(Address of principal offices) (Zip Code)
Registrant’s
telephone number, including area code: (214)242-9619
Securities
registered pursuant to section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
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 15(d) of the Act: ☐ Yes ☒ No
Indicate
by check mark whether the registrant (1) has filed all reports required 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. ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). ☐ Yes ☒ No
On
June 30, 2024, the last day of the registrant’s most recently completed second quarter, the aggregate market value of the Common
Stock held by non-affiliates of the registrant was approximately $5,862,777, based upon the closing price of the registrant’s Common
Stock on the Nasdaq Capital Market of $4.56 on June 28, 2024. For purposes of this response, the registrant has assumed that its directors,
executive officers and beneficial owners of 5% or more of its Common Stock are deemed affiliates of the registrant. For purposes
of calculating the aggregate market value of shares held by non-affiliates, we have assumed that all outstanding shares are held by non-affiliates,
except for shares held by each of our executive officers, directors and 5% or greater stockholders. In the case of 5% or greater stockholders,
we have not deemed such stockholders to be affiliates unless there are facts and circumstances which would indicate that such stockholders
exercise any control over our company, or unless they hold 10% or more of our outstanding common stock. These assumptions should not
be deemed to constitute an admission that all executive officers, directors and 5% or greater stockholders are, in fact, affiliates of
our company, or that there are not other persons who may be deemed to be affiliates of our company. Further information concerning shareholdings
of our officers, directors and principal stockholders is included or incorporated by reference in Part III, Item 12 of this Annual Report
on Form 10-K.
As
of March 20, 2025, the registrant had 5,168,796 shares of its Common Stock, $0.0001 par value, outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
None.
TABLE
OF CONTENTS
Cautionary Statement Regarding Forward-Looking Statements 1
Reverse Stock Split 2
Glossary of Industry Terms 3
PART I 4
Item 1. Business. 4
Item 1A. Risk Factors. 29
Item 1B. Unresolved Staff Comments. 69
Item 1C. Cybersecurity 69
Item 2. Properties. 70
Item 3. Legal Proceedings. 71
Item 4. Mine Safety Disclosures. 71
Item 6. [Reserved] 72
Item 7A. Quantitative and Qualitative Disclosures About Market Risk. 89
Item 8. Financial Statements and Supplementary Data. 90
Item 9A. Controls and Procedures. 91
Item 9B. Other Information. 92
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 92
PART III 93
Item 10. Directors, Executive Officers and Corporate Governance. 93
Item 11. Executive Compensation. 102
Item 14. Principal Accountant Fees and Services. 130
Item 15. Exhibits and Financial Statement Schedules. 132
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Cautionary
Statement Regarding Forward-Looking Statements
This
Annual Report on Form 10-K (this “Report”) contains forward-looking statements within the meaning of the federal securities
laws, including the Private Securities Litigation Reform Act of 1995, regarding future events and the future results of Mangoceuticals,
Inc. (the “Company”) that are based on current expectations, estimates, forecasts, and projections about the industry
in which the Company operates and the beliefs and assumptions of the management of the Company. In some cases, you can identify forward-looking
statements by the following words: “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “ongoing,”
“plan,” “potential,” “predict,” “project,” “should,”
or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking
statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or
by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the
statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity,
performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in
this Report. Factors that might cause or contribute to such differences include, but are not limited to, those discussed elsewhere in
this Report, including under, or incorporated by reference into, “Risk Factors”, which factors include:
● our ability to build and maintain our brand;
● shipping, production or manufacturing delays;
● our ability to increase sales;
● our dependency on third-parties to prescribe and compound our products;
● our ability to adequately support future growth; and
● other risk factors included under “1A. Risk Factors” below.
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These
statements are not guarantees of future performance or results. Forward-looking statements are based on information available at the
time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels
of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking
statements in this Report. These factors include those set forth below under “Item 1A. Risk Factors”, below.
In
addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject.
These statements are based on information available to us as of the date of this Annual Report on Form 10-K. While we believe that such
information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not
be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently
uncertain, and investors are cautioned not to unduly rely on these statements.
You
should read the matters described in “Item 1A. Risk Factors” and the other cautionary statements made in this Report, and
incorporated by reference herein, as being applicable to all related forward-looking statements wherever they appear in this Report.
We cannot assure you that the forward-looking statements in this Report will prove to be accurate and therefore prospective investors
are encouraged not to place undue reliance on forward-looking statements. Other than as required by law, we undertake no obligation to
update or revise these forward-looking statements, even though our situation may change in the future.
Reverse
Stock Split
On
March 25, 2024, at a special meeting of the Company’s stockholders (the “Special Meeting”), the stockholders
of the Company approved an amendment to our Certificate of Formation, as amended and restated, to effect a reverse stock split of our
issued and outstanding shares of our common stock, par value $0.0001 per share, by a ratio of between one-for-two to one-for-fifty inclusive,
with the exact ratio to be set at a whole number to be determined by our Board of Directors or a duly authorized committee thereof in
its discretion, at any time after approval of the amendment and prior to March 25, 2025 (the “Stockholder Authority”).
On
October 7, 2024, the Company’s Board of Directors (the “Board”), with the Stockholder Authority, approved an
amendment to our Certificate of Formation, as amended and restated, to effect a reverse stock split of our common stock at a ratio of
1-for-15 (the “Reverse Stock Split”). The Reverse Stock Split is more fully described in the Company’s definitive
proxy statement, which was filed with the Commission on March 1, 2024.
On
October 8, 2024, we filed a Certificate of Amendment to our Certificate of Formation, as amended and restated (the “Certificate
of Amendment”) with the Secretary of State of the State of Texas to affect the Reverse Stock Split.
Pursuant
to the Certificate of Amendment, the Reverse Stock Split became effective on October 16, 2024, at 12:01 a.m. Eastern Time (the “Effective
Time”). The shares of the Company’s common stock began trading on the Nasdaq Capital Market (“Nasdaq”)
on a post-split basis on October 16, 2024, with new CUSIP number: 56270V205. No change was made to the trading symbol for the Company’s
shares of common stock, “MGRX”, in connection with the Reverse Stock Split.
At
the Effective Time, every fifteen (15) shares of issued and outstanding common stock were converted into one (1) share of issued and
outstanding common stock, and the total outstanding shares of common stock were reduced from approximately 35.5 million to approximately
2.4 million, without giving effect to any rounding up of fractional shares.
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No
fractional shares were issued in connection with the Reverse Stock Split. Stockholders of record who otherwise would be entitled to receive
fractional shares, were entitled to have their fractional shares rounded up to the nearest whole share. No stockholders received cash
in lieu of fractional shares. Shortly after the Reverse Stock Split, and upon a comprehensive review, the Company became aware and was
informed of highly irregular trading patterns and an unprecedented increase in the number of shareholder
accounts resulting in concerns about potential stock manipulation. The Company continues to monitor and investigate this matter and has
approved certain round up share requests on a case-by-case basis.
In
addition, the number of shares of common stock issuable upon exercise of our stock options and other equity awards (including shares
reserved for issuance under the Company’s equity compensation plan) were proportionately adjusted by the applicable administrator,
using the 1-for-15 ratio, to be effective at the Effective Time, pursuant to the terms of the Company’s equity plans. In addition,
the exercise price for each outstanding stock option and warrant will be increased in inverse proportion to the 1-for-15 split ratio
such that upon an exercise, the aggregate exercise price payable by the optionee or warrant holder to the Company for the shares subject
to the option or warrant will remain approximately the same as the aggregate exercise price prior to the Reverse Stock Split, subject
to the terms of such securities. Similar changes were made to other outstanding convertible securities.
The
effects of the Reverse Stock Split have been retroactively reflected throughout this Report unless otherwise stated.
Glossary
of Industry Terms
The
following are abbreviations, acronyms and definitions of certain terms used in this document, which are commonly used in our industry:
“cGMP”
means current good manufacturing practice regulations promulgated by the FDA under the authority of the FFDCA. These regulations, which
have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive
steps to ensure that their products are safe, pure, and effective.
“FFDCA”
means the Federal Food, Drug and Cosmetic Act, which is a set of U.S. laws passed by Congress in 1938 giving authority to the FDA to
oversee the safety of food, drugs, medical devices, and cosmetics.
“HIPAA”
means the Health Insurance Portability and Accountability Act of 1996, which has the goal of making it easier for people to keep health
insurance, protect the confidentiality and security of healthcare information and help the healthcare industry control administrative
costs.
“HITECH”
means the Health Information Technology for Economic and Clinical Health Act.
“IU”
means International Unit, which is a unit of measurement for the effect, not mass of a substance; the variance is based on the biological
activity or effect, for the purpose of easier comparison across similar forms of substances. IUs are used to measure the activity of
many vitamins, hormones, enzymes, and drugs.
“Individually
identifiable health information” is defined by HIPPA to mean information that is a subset of health information, including
demographic information collected from an individual, and: (1) is created or received by a health care provider, health plan, employer,
or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual;
the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual;
and (a) that identifies the individual; or (b) with respect to which there is reasonable basis to believe the information can be used
to identify the individual.
“Mg”
means milligrams.
“NCPDP”
means the National Council for Prescription Drug Programs, which is an American National Standards Institute accredited, standards development
organization providing healthcare solutions.
“NPI”
means National Provider Identifier, which is a Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification
Standard. The NPI is a unique identification number for covered health care providers.
“PII”
means personal identifiable information.
“TSBP”
means The Texas State Board of Pharmacy, which is the state agency responsible for the licensing/registration of Texas pharmacists, pharmacy
technicians, and pharmacies; for establishing regulations for pharmacy practice; and for disciplining licensees and registrants.
“URAC”
means the Utilization Review Accreditation Commission, which is a review accreditation commission which offers health organizations an
opportunity to have trained reviewers examine their operations and publicly ensure they are delivering care in a manner consistent with
national standards.
Table of Contents
PART
I
Item
1. Business.
Introduction
The
information included in this Report on Form 10-K should be read in conjunction with the consolidated financial statements and related
notes in “Item 8. Financial Statements and Supplemental Data” of this Report.
Our
logo and some of our trademarks and tradenames are used in this Report. This Report also includes trademarks, tradenames and service
marks that are the property of others. Solely for convenience, trademarks, tradenames, and service marks referred to in this Report may
appear without the ®, TM and SM symbols. References to our trademarks, tradenames and service marks are not intended to indicate
in any way that we will not assert to the fullest extent under applicable law our rights or the rights of the applicable licensors if
any, nor that respective owners to other intellectual property rights will not assert, to the fullest extent under applicable law, their
rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with,
or endorsement or sponsorship of us by, any other companies.
The
market data and certain other statistical information used throughout this Report are based on independent industry publications, reports
by market research firms or other independent sources that we believe to be reliable sources. Industry publications and third-party research,
surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do
not guarantee the accuracy or completeness of such information; and we have not commissioned any of the market or survey data that is
presented in this Report. We are responsible for all the disclosures contained in this Report, and we believe these industry publications
and third-party research, surveys and studies are reliable. While we are not aware of any misstatements regarding any third-party information
presented in this Report, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to
risks and uncertainties, and are subject to change based on various factors, including those discussed under the section entitled “Item 1A. Risk Factors”. These and other factors could cause our future performance to differ materially from our assumptions and estimates.
Some market and other data included herein, as well as the data of competitors as they relate to Mangoceuticals, Inc., is also based
on our good faith estimates.
Unless
the context requires otherwise, references to the “Company,” “we,” “us,” “our,”,
“MangoRx” and “Mangoceuticals” in this Report refer specifically to Mangoceuticals, Inc., and its
consolidated subsidiaries.
In
addition, unless the context otherwise requires and for the purposes of this report only:
● “Exchange Act” refers to the Securities Exchange Act of 1934, as amended;
● “Securities Act” refers to the Securities Act of 1933, as amended.
All
dollar amounts in this Report are in U.S. dollars unless otherwise stated.
Available
Information
We
file annual, quarterly, and current reports, proxy statements and other information with the SEC. The SEC maintains an Internet site
that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC
like us at https://www.sec.gov and can also be accessed free of charge on the “Investors” section of our website
under the heading “SEC Filings”. Copies of documents filed by us with the SEC (including exhibits) are also available
from us without charge, upon oral or written request to our Secretary, who can be contacted at the address and telephone number set forth
on the cover page of this Report. Our website address is www.mangoceuticals.com. Our annual reports on Form 10-K, quarterly
reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed pursuant to Section 13(a) or 15(d) of the Exchange
Act of 1934 will be available through our website free of charge as soon as reasonably practical after we electronically file such material
with, or furnish it to, the SEC. The information on, or that may be accessed through, our website is not incorporated by reference into
this Report and should not be considered a part of this Report.
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Organizational
History
We
are a Texas corporation formed on October 7, 2021. Our address is 15110 N. Dallas Parkway, Suite 600, Dallas, Texas 75248. Our telephone
number is (214) 242-9619. Our website is www.MangoRX.com. We became a public reporting company on March 20, 2023, upon the effectiveness
of our Registration Statement on Form S-1 in connection with our initial public offering. Our common stock is traded on the Nasdaq Capital
Market under the symbol “MGRX”.
Overview
We
connect consumers to licensed healthcare professionals through our website at www.MangoRX.com, for the provision of care via telehealth
on our customer portal. We also focus on developing, marketing, and selling a variety of men’s wellness products and services via
a telemedicine platform. To date, the Company has identified men’s wellness telemedicine services and products as a growing sector
in the most recent years and especially related to the areas of erectile dysfunction (“ED”), hair loss, testosterone
replacement or enhancement therapies, and weight management treatments. In this regard, we have developed and are commercially marketing
a brand of ED products under the brand name “Mango,” a brand of hair loss products under the brand name “Grow,”
a brand of hormone balance and therapy products under the name “Mojo,” and a brand of weight loss products under the
brand name “Slim” (Mango, Grow, Mojo, and Slim are collectively referred to as the “Compounded Products”).
The
Company is also marketing and selling an U.S. Food and Drug Administration (“FDA”) approved form of oral testosterone
undecanoate to treat low testosterone in men and as a form of Testosterone Replacement Therapy (TRT), developed and produced by Marius
Pharmaceuticals, Inc. under the brand name “Prime” powered by Kyzatrex® (“Prime”) (Prime and
our Compounded Products collectively referred to as the “Pharmaceutical Products”). We also provide access for customers
to a licensed pharmacy for online fulfillment and distribution of certain medications that may be prescribed as part of telehealth consultations.
The
Company, through the patent portfolio acquired as part of the Intramont IP Purchase Agreement (as further described below), is in the
process of conducting Phase II clinical trials and efficacy studies to determine the effectiveness of its patented respiratory illness
prevention technology against the likes of the influenza A virus (H1N1) and avian influenza (H5N1). The studies are anticipated to be
completed in the 2nd quarter of 2025 which will then determine the Company’s next steps in its commercialization and
monetization efforts.
The
Company, through its Master Distribution Agreement with Propre Energie, Inc. (“Propre”)(as further described below) intends
to license certain intellectual property and patent rights from Propre relating to clinically proven, plant-based formulations targeting
hyperpigmentation, dark spots, uneven skin tone, and skin brightening through advanced solutions marketed under the brand Dermytol®
(“Dermytol”). The Company is in the process of preparing its marketing and distribution strategy for Dermytol and intends
to commence operations under this agreement in the 3rd quarter of 2025.
All
Compounded Products are produced at and fulfilled by Epiq Scripts, LLC (“Epiq Scripts”), a related party compounding
pharmacy, and are available to patients on the determination of a prescribing physician that the compounded drug is necessary for the
individual patient. The Company also uses Epiq Scripts to fulfill all patient orders of Prime (as further discussed below).
Our
MangoRx branded Compounded Products currently consist of the following:
Mango
ED - This product currently includes the following three ingredients: Either Sildenafil (the active ingredient in Viagra) or
Tadalafil (the active ingredient in Cialis), and Oxytocin, all of which are used in FDA approved drugs, as well as L-Arginine, an amino
acid that is available as a dietary supplement. Epiq Scripts is currently 52% owned by Mr. Jacob D. Cohen, our Chairman and Chief Executive
Officer.
We
currently offer two dosage levels of our Mango ED product and anticipate doctors prescribing a dosage based on the needs and medical
history of the patient. Our Mango ED product currently includes the following amounts of the three ingredients: (1) either Sildenafil
(50 milligrams (mg)) or Tadalafil (10 (mg)), Oxytocin (100 International units (IU)) and L-Arginine (50mg); and (2) either Sildenafil
(100 milligrams (mg)) or Tadalafil (20mg), Oxytocin (100IU) and L-Arginine (50mg).
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Our
Mango ED product has not been, and will not be, approved by the FDA and instead we produce and sell our products, including our Mango
ED product, under an exemption provided by Section 503A of the Federal Food, Drug and Cosmetic Act (“FFDCA Act”),
as discussed below. Additionally, because our Mango ED product is being specially compounded for the customer by a pharmacist with a
physician’s prescription and because the ingredients for our Mango ED product are publicly disclosed, this product formula can
be replicated by other companies.
We
are not aware of any clinical studies involving (i) administration of Tadalafil or Sildenafil sublingually at the doses we provide patients,
or (ii) compounding of Tadalafil or Sildenafil, Oxytocin, and L-arginine to treat ED, similar to our Mango ED products. We are, however,
aware of other companies that are currently selling oral disintegrating tablets for ED, including those using a combination of Tadalafil
(the active ingredient in Cialis) and Sildenafil (the active ingredient in Viagra). We believe that the potential safety risks associated
with our Mango ED products are comparable to the safety risks associated with oral formulations of Tadalafil and Sildenafil approved
by the FDA for the treatment of ED. We do not expect significant safety risks associated with L-arginine, as the FDA has recognized in
its regulations that L-arginine may be safely added as a nutrient to foods. Clinical studies of intranasal Oxytocin have also found that
Oxytocin is generally safe and well-tolerated.
‘GROW’
by MangoRx - Mango GROW currently includes the following four ingredients - (1) Minoxidil (the active ingredient in Rogaine®)
and (2) Finasteride (the active ingredient in Propecia), each of which is used in FDA approved drugs, as well as (3) Vitamin D3 and (4)
Biotin, which are available as dietary supplements. However, the fact that Minoxidil and Finasteride are used in FDA approved drugs,
and that Vitamin D3 and Biotin, are available as a dietary supplement, does not mean that these ingredients will prove safe when combined
into a single formulation to attempt to treat hair growth. Mango GROW is encapsulated in convenient chewable, mint-flavored rapid dissolve
tablets (“RDT”).
We
currently offer one dosage level of our Mango GROW product and anticipate doctors prescribing Mango GROW based on the needs and medical
history of the patient. Our Mango GROW product currently includes the following amounts of the four ingredients: (1) Minoxidil (2.5mg),
(2) Finasteride (1mg), (3) Vitamin D3 (2000IU) and (4) Biotin (1mg). Our Mango GROW product has not been, and will not be, approved by
the FDA and instead we produce and sell our Mango GROW product and plan to produce and sell future pharmaceutical products, under an
exemption provided by Section 503A of the FFDCA Act.
We
are not aware of any clinical studies involving the administration of Minoxidil and Finasteride sublingually at the dose we provide patients,
or the compounding of Minoxidil, Finasteride, Vitamin D3, and Biotin, to treat hair growth, as is contemplated by our Mango GROW product.
We are, however, aware of other companies that are currently selling oral tablets for hair growth, including those using a combination
of Minoxidil and Finasteride. Additionally, because our Mango GROW product is being specially compounded for the customer by a pharmacist
with a physician’s prescription and because the ingredients for our Mango GROW product are publicly disclosed, this product formula
can be replicated by other companies.
‘SLIM’
by MangoRx - SLIM currently includes the following two ingredients - (1) Vitamin B6, which is available as dietary supplement,
and (2) Semaglutide, the active ingredient used in an FDA approved drug. However, the fact that Semaglutide is used in an FDA approved
drug, and that Vitamin B6 is available as a dietary supplement, does not mean that these ingredients will prove safe when combined into
a single formulation to attempt to assist with weight loss or weight management. SLIM is encapsulated in convenient chewable, mint-flavored
RDT.
We
currently offer four dosage levels of our SLIM product and anticipate doctors prescribing SLIM based on their needs and medical history
of the patient. Our SLIM product currently includes the (1) Vitamin B6 (10mg), and (2) Semaglutide, in either 0.5mg, 1.0mg, 1.5mg or
2.0mg variations, which amount is based on the prescribing practitioner. Our SLIM product has not been, and will not be, approved by
the FDA and instead we produce and sell our SLIM product and plan to produce and sell future pharmaceutical products, under an exemption
provided by Section 503A of the FFDCA Act.
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We
are not aware of any clinical studies involving the administration of Semaglutide as a RDT at the dose we provide patients, or the compounding
of Semaglutide and Vitamin B6, to treat weight loss or weight management, as is contemplated by our SLIM product.
‘MOJO’
by MangoRx - This product is produced at our related party compounding pharmacy and is available to patients on the determination
of a prescribing physician that the compounded drug is necessary for the individual patient. MOJO currently includes the following three
ingredients - (1) Dehydroepiandrosterone (“DHEA”), which is available as dietary supplement, (2) Pregnenolone, which
is available as a dietary supplement, and (3) Enclomiphene Citrate, one of the active ingredients in Clomid and is used in an FDA approved
drug. However, the fact that Enclomiphene Citrate is used in an FDA approved drug, and that DHEA and Pregnenolone are available as a
dietary supplement, does not mean that these ingredients will prove safe when combined into a single formulation to attempt to treat
hormone imbalances. MOJO is encapsulated in convenient chewable, mango-flavored RDT.
We
currently offer one dosage level of our MOJO product and anticipate doctors prescribing MOJO based on their needs and medical history
of the patient. Our MOJO product currently includes the following amounts of the three ingredients: (1) DHEA (10mg), (2) Pregnenolone
(5mg) and (3) Enclomiphene Citrate (25mg).
We
are not aware of any clinical studies involving the administration of Enclomiphene as a RDT at the dose we provide patients, or the compounding
of DHEA, Enclomiphene, and/or Pregnenolone, to treat hormone imbalances, as is contemplated by our MOJO product.
Additional
Information Regarding our Compounded Products
Because
our Compounded Products have not been, and will not be, approved by the FDA, our products have not had the benefit of the FDA’s
clinical trial protocol which seeks to prevent the possibility of serious patient injury and death. If this were to occur, we could be
subject to litigation and governmental action, which could result in costly litigation, significant fines, judgments or penalties.
We
currently anticipate using funding we may raise in the near term to finance marketing and general operational expenses associated with
the sale of our Pharmaceutical Products. We launched our website in mid-November 2022.
Our
Compounded Products have been formulated as rapid dissolving tablets (RDT) using a sublingual (applied under the tongue) delivery system
to bypass the stomach and liver. It is a generally established principle that sublingual drug absorption through the oral mucosa is generally
faster than drug absorption through the gastrointestinal tract. This is because sublingual drugs that are absorbed through the oral mucosa
directly enter the systemic circulation, bypassing the gastrointestinal tract and first-pass metabolism in the liver (see H. Zhang et
al., Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic applications, 41 Clin
Pharmacokinet 661, 662 (2002). Though the active ingredients that comprise our Mango ED product are meant to treat ED –
an issue that according to a 2018 study published in The Journal of Sexual Medicine has been estimated to affect over one-third
of today’s men’s population (with prevalence increasing with age) – we are also aiming to brand ourselves as a lifestyle
company marketed to men seeking enhanced sexual vitality, performance, and overall mood and confidence.
‘PRIME’
by MangoRx, Powered by Kyzatrex® - ‘PRIME’, by MangoRx, powered by Kyzatrex®, a FDA-approved oral
Testosterone Replacement Therapy (TRT) product, available by prescription, that is used to treat adult men who have low or no testosterone
levels due to certain medical conditions. ‘PRIME’, by MangoRx, powered by Kyzatrex® is one of only three FDA
approved TRT treatments that is delivered orally—as opposed to the traditional, invasive, and inconvenient injection-based drug
delivery protocol. ‘PRIME’, by MangoRx, powered by Kyzatrex® delivers testosterone in a softgel capsule that
is absorbed primarily via the lymphatic system, avoiding liver toxicity. The benefits of ‘PRIME,’ powered by Kyzatrex®,
over traditional injectable TRTs include enhanced vitality, improved mood, sharper cognition, optimized physical performance, and balanced
hormonal levels at 96% efficacy by day 90, as demonstrated in Phase 3 clinical research by Marius Pharmaceuticals. With ‘PRIME,’
MangoRx is working to expand broad-based consumer access to this therapy.
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Our
Contracted Telehealth Providers
In
many states, including Texas where our principal business office is located, the corporate practice of medicine doctrine prohibits corporations
from practicing medicine and from employing physicians to provide professional medical services. Many states that recognize this doctrine
also prohibit physicians from agreeing to share the fees they receive for professional services with unlicensed entities or individuals,
a practice that is commonly known as “fee splitting.” The requirements for compliance with any applicable corporate
practice of medicine and fee splitting restrictions vary among the states. In Texas, for example, there is no statute that expressly
prohibits fee splitting, but the corporate practice of medicine doctrine has been interpreted to prohibit physicians from ceding control
over their fee structures to corporate entities or giving a substantial portion of the fees received to corporate entities.
In
order to comply with corporate practice of medicine and fee splitting restrictions, we do not employ or directly contract with individual
physicians or physician groups, nor do we control their medical decision-making or charges. Rather, the Company has entered into a variety
of physician services agreements (the “Physicians Agreements”) with BrighterMD, LLC doing business as Doctegrity (“Doctegrity”),
LocumTele, and Locum Tenens USA (collectively, the “Telemedicine Providers”), all of which counterparties have agreed
to make available to us, healthcare professionals, to allow them to provide clinical services directly to our future customers via telehealth.
We have integrated these healthcare professionals to allow for telehealth consultations and related services on our Mangoceuticals platform
which has been developed and is complete. This platform is the backbone of our business as it connects consumers with both the medical
provider and the pharmacy for fulfillment. It is also the system that we will use to create marketing funnels for outgoing marketing,
customer management and support, and analytics for future sales.
Through
our Physician Agreements, the healthcare professionals are responsible for the practice of medicine and control of the clinical decision-making.
After
a patient visits our website and submits a request for a consultation with a health care professional, our Telemedicine Providers communicate
the patient’s information to one of their affiliated physicians. The Telemedicine Providers and their physicians are responsible
for conducting the telehealth consultation and any ongoing communication with the patient in accordance with applicable laws. The physicians
make a determination, in their sole discretion, as to whether or not to prescribe our Pharmaceutical Products to potential customers.
If the physicians prescribe our Pharmaceutical Products, then the customers pay us for our products. In turn, Epiq Scripts, LLC, pursuant
to the Master Services Agreement discussed below, is provided information on the customer and compounding of our product, compound the
product, and ship the product to customers using packaging and shipping materials which we supply.
We
pay the Telemedicine Providers for each physician visit conducted in response to request made by a patient on our website, regardless
of whether the physician prescribes our product to the patient. The fee we pay the Telemedicine Providers is fixed, set in advance and
is negotiated at arms’ length after comparing the prices offered by similar services. We are not a party to any contracts between
the Telemedicine Providers and any health professionals or physician groups and do not control how the Telemedicine Providers reimburse
these providers.
Although
our arrangement with the Telemedicine Providers, as summarized above, is structured to comply with applicable laws, including those restricting
the corporate practice of medicine and fee splitting, there may be a risk that a state agency, now or in the future as these laws (and
interpretations of them) evolve, would conclude that the arrangement and fee structure between the Telemedicine Providers and their contracted
physicians and/or our agreements with the Telemedicine Providers violate the corporate practice of medicine doctrine and fee splitting
restrictions in Texas or in another state where a patient who uses our Mangoceuticals platform is located.
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The
Telemedicine Providers’ physicians are tasked with determining whether patients seeking our Pharmaceutical Products are eligible
to be prescribed our Pharmaceutical Products, with the sole purpose of the telemedicine engagement being for the determination, in the
physician’s sole judgment, of whether the patient is qualified to obtain a prescription for the Pharmaceutical Products. The Telemedicine
Providers’ physicians are required to electronically send prescriptions to Epiq Scripts (the Company’s designated and accredited
pharmacy partner), which financial relationship is required to be disclosed in writing to the patient via the Terms and Conditions listed
on the Company’s website, including informed consent, and also informing the patient that the prescription is sent to the Company’s
designated pharmacy partner. The Telemedicine Providers’ physicians are only able to prescribe our Pharmaceutical Products to patients
seeking help for the treatment which the specific product provides (for example, Mango ED for treatment for ED and GROW for treatment
hair loss) through our customer portal.
Our
Related Party Pharmacy
As
discussed in greater detail below under “—Material Agreements—Master Services Agreement with Epiq Scripts”
we have entered into an exclusive Master Services Agreement and statement of work with Epiq Scripts, LLC, for its specialty compounding
and packaging capabilities, fulfillment, and distribution of certain prescription products available through our platform. These prescription
products include our Pharmaceutical Products. Epiq Scripts is a related party because it was 51%-owned by American International Holdings
Corp (“American International”) at the time of our entry into the Master Services Agreement and is currently 52% owned
by Mr. Jacob D. Cohen, our Chairman and Chief Executive Officer. Mr. Cohen, our Chairman and Chief Executive Officer, also served as
the Chief Executive Officer and a director of, and had voting control over, American International at the time of the entry into the
Master Services Agreement. Our company was previously wholly-owned by American International until April 16, 2022, when control of our
company was sold to Cohen Enterprises, Inc., which entity is owned by Jacob D. Cohen, the Chairman and Chief Executive Officer of the
Company (“Cohen Enterprises”). Epiq Scripts was formed in January 2022 and only began compounding drugs for patients
in November 2022. On February 15, 2023, the 51% of Epiq Scripts then owned by American International was transferred to Mr. Cohen as
part of an exchange transaction, whereby Mr. Cohen agreed to cancel his preferred stock of American International, which provided him
voting control over American International, in exchange for among other assets, American International’s ownership of Epiq Scripts.
Epiq Scripts is currently 52% owned by Mr. Cohen, our Chairman and Chief Executive Officer. Additionally, Mr. Cohen has served as the
co-Manager of Epiq Scripts since January 2022.
Epiq
Scripts is currently fully licensed with the Texas State Board of Pharmacy (“TSBP”) and further has State Board of
Pharmacy (or its equivalent) licenses from the District of Columbia and 49 other states: Alaska, Arizona, Arkansas, California, Colorado,
Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts,
Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina,
North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, Virginia, Washington,
West Virginia, Wisconsin, and Wyoming, with the intent of obtaining a state license from Alabama, the remaining state by the end of the
first quarter of 2025. Epiq Scripts has obtained its National Provider Identifier (“NPI”)
number and is now a member of the National Council for Prescription Drug Programs (“NCPDP”), a standards development
organization. Additionally, Epiq Scripts has applied for the highest level of accreditation with the Utilization Review Accreditation
Commission (“URAC”), a Washington DC-based healthcare accrediting organization
that establishes quality standards for the entire healthcare industry. Until Epiq Scripts receives a licenses in Alabama, we are
limited to selling our Pharmaceutical Products in only the states in which Epiq Scripts holds licenses. Although Epiq Scripts is physically
located in Texas, it can ship products to customers in each state in which it holds licenses.
As
a result of the above, Epiq Scripts can currently only provide services to the Company in the District of Columbia and those 49 states
described above and the Company will be unable to sell its products to any customers in any states other than those listed above, until
Epiq Scripts is able to obtain licenses in other states and will thereafter be limited to selling products to customers only in the states
in which Epiq Scripts holds licenses.
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Our
Customer Portal
Our
customer platform connects consumers to licensed healthcare professionals through our website at www.MangoRX.com, for the provision
of care via telehealth and also provides access for customers to a licensed pharmacy for online fulfillment and distribution of certain
medications that may be prescribed as part of telehealth consultations. Additional features to this backend technology solution allow
for the creation and management of customer accounts whereby customers have the ability to login, view and make changes to their respective
accounts. These changes include, but are not limited to, reviewing order history, tracking order shipments, requesting and ordering product
refills and making other profile changes such as shipping address and payment changes. Our portal is not unique to the industry and is
not anticipated to be difficult or costly to replicate or replace.
The
backend technology solution also houses and manages all customer data allowing the Company with additional key functionality, including
but not limited to, providing customer service and support and data analytics for various marketing initiatives and reporting functions.
We
do not anticipate selling any third-party products via our portal.
Our
Growth Strategy
Utilize
a variety of marketing channels using data analytics to attract customers
We
currently market and advertise our Pharmaceutical Products on a variety of advertising mediums including, but not limited to, social
media, online search websites, podcasts, television, radio, out-of-home, and other media channels, in compliance with applicable FDA
rules and requirements. However, due to such rules and requirements, we are extremely limited in the content of the claims and promotional
statements that we are able to make regarding our products under applicable FDA regulations. We believe advertising in a diversified
set of media channels is important to prevent overreliance on any single channel and to maximize the exposure of our brand to our desired
customers. We also reach customers through our own social media accounts, press coverage and public relations, internally developed educational
and lifestyle content, and through engagement of social media influencers, hired and paid celebrities and talent, and physical brand
advertising campaigns, in each case funding permitting, and in each case subject to applicable rules and regulations, which are expected
to significantly limit the content of such marketing materials. We believe that this overall strategy will drive significant customer
traffic to our platform, including direct type-in traffic and organic online search traffic.
We
also utilize a marketing strategy focused on analytics and data. We have designed our internal systems to measure consumer behavior,
including which types of consumers generate more revenue in their first purchase, generate more revenue over time, generate more gross
profit from their purchases, and which types of consumers are most valuable over their lifetime. We plan on measuring the effectiveness
of our marketing budgets and the rate of return we generate from our marketing campaigns. We have retained and plan on using outside
marketing and advertising firms to assist management in identifying marketing and advertising campaigns, media purchases and mediums,
and seeking to drive a sufficient rate of return from our marketing and advertising budgets.
Invest
in our telemedicine platform to enable sales throughout the United States
We
utilize both a synchronous and asynchronous approach through our telemedicine platform, connecting customers through our platform and
contracted physicians and pharmacy. An asynchronous visit allows a physician to verify the patient’s identity, demographics and
collect the medical history online without needing to physically see or speak to the patient. A synchronous visit requires the doctor
to either speak directly to the patient and/or see the patient either via video conference or in person. As discussed above, we initially
are focusing our sales in the District of Columbia and 49 states where our related party pharmacy is licensed, with the goal of eventually
undertaking sales across all 50 states, pending licensing approvals of our related party pharmacy.
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Provide
subscription plans for recurring revenue and introduction of new products
We
provide our customers with an option to purchase our Pharmaceutical Products on a subscription basis, where and when applicable. Subscription
plans provide an easy and convenient way for customers to get ongoing treatment while simultaneously providing the Company with predictability
through a recurring revenue stream.
For
subscription plans, customers are able to select a desired timeframe in which to receive products, which range from once every month
to once every six months. The customer will then be billed on a recurring basis based on the selected timeframe and specified quantity
of product, which is shipped after each billing from our contracted pharmacy (Epiq Scripts). Customers are able to cancel subscriptions
in between billing periods to stop receiving additional products and reactivate subscriptions. Our integrated technology platform serves
customers from customer discovery, through the purchase of products on our website, to connecting customers with medical providers for
telehealth consultations (through our contracted physician network), to the fulfillment and delivery of orders (through our contracted
pharmacy), and finally through ongoing management by medical providers (also through our contracted physician network). We believe our
platform provides us cost advantages and efficiencies to offer customers affordable prices and to generate increased revenues over time.
In
addition to our Pharmaceutical Products, we intend to launch new products over time and offer additional subscription-based offerings
which we hope will result in growth in revenue through recurring revenue streams.
Parent
Subsidiary Contribution Agreement
On
December 13, 2024, the Company, entered into a Parent Subsidiary Contribution Agreement with Mango & Peaches Corp., a Texas corporation
(“Mango & Peaches”), a then recently formed wholly-owned subsidiary of the Company (the “Contribution
Agreement”). Pursuant to the Contribution Agreement, the Company contributed substantially all of its assets, including ownership
of: (a) its 98% ownership of MangoRx Mexico S.A. de C.V., a Mexican Stock Company; and (b) its 100% ownership of MangoRx UK Limited,
a company incorporated under the laws of the United Kingdom (collectively, the “Contributed Assets”), to Mango &
Peaches, in order to restructure the ownership and operations of the Company, better segregate such operations and liabilities and provided
for the issuance of a portion of the capital of Mango & Peaches to Mr. Jacob Cohen, the Chief Executive Officer of the Company, as
additional consideration to Mr. Cohen, as discussed in greater detail below under “Item 11. Executive Compensation”—“Employment
and Consulting Agreements”— “Jacob D. Cohen, Chief Executive Officer”, pursuant to which the Company