Mangoceuticals, Inc. Announces Completion of First Batch of Mango ED Products for Marketing and Distribution in Mexico and Latin American Markets

Rhea-AI Summary

Mangoceuticals announced the completion of its first batch of Mango ED oral dissolvable tablets (ODTs) for the Mexican and Latin American markets. These tablets, containing Tadalafil, will undergo tests in the U.S. for quality assurance. The next phase includes producing three additional lots for bioequivalence and stability testing in Mexico to meet COFEPRIS standards. This effort is in collaboration with Emifarma. The ED market in Mexico is valued at $216 million annually, growing at 4% per year. MangoRx aims to expand into other LATAM countries post-COFEPRIS certification.

Positive

• Completion of first batch of Mango ED ODTs for Mexico and LATAM markets.
• Tablets contain Tadalafil and are undergoing U.S. lab testing for quality.
• Collaboration with Emifarma indicates robust local partnerships.
• Mexican ED market valued at $216 million, growing at 4% annually.
• Potential expansion into other LATAM markets post-COFEPRIS certification.

Negative

• Pending completion of bioequivalence and stability testing for COFEPRIS certification.
• No immediate revenue generation until regulatory approvals are obtained.

Insights

Market Research Analyst

Mangoceuticals, Inc. (MGRX) has completed the first batch of its Mango ED products targeted for the Mexican and Latin American markets. This development is pivotal for the company's international expansion. A recent survey indicates that the ED pharmaceutical market in Mexico is valued at USD $216 million, with a growth rate of 4%. Given the robust demand, this move can significantly boost Mangoceuticals' revenue streams. However, the company must still pass bioequivalence and stability tests to receive COFEPRIS certification, important for commercialization in Mexico and other Latin American countries. Investors should monitor these milestones closely.

Financial Analyst

From a financial perspective, Mangoceuticals' entry into the Latin American market offers promising revenue diversification. Mexico's ED market size and annual growth are substantial and pricing at USD $8.50 per unit suggests a lucrative opportunity. However, investors should be aware of the costs associated with regulatory compliance and market penetration. The successful completion of bioequivalence and stability testing will determine the timing of revenue inflows and the company's ability to capitalize on this market. Long-term financial stability may benefit, but short-term expenses could impact profitability.

Pharmaceutical Quality Control Specialist

The current batch of Mango ED products is undergoing third-party testing to ensure quality and consistency. This step is essential for gaining COFEPRIS certification, which is a stringent regulatory requirement in Mexico. This certification not only validates the product's efficacy and safety but also opens doors to multiple Latin American markets that recognize COFEPRIS standards. Nevertheless, the process involves producing additional batches for bioequivalence and stability testing, which are important steps that can affect the timeline of the product's market entry. Investors should consider the potential delays and costs associated with these regulatory hurdles.

Dallas, Texas, May 28, 2024 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling a variety of men’s health and wellness products in the area of erectile dysfunction (ED), hair growth, weight loss and hormone replacement therapies, is pleased to announce that its subsidiary, MangoRx Mexico S.A. de C.V. (“MangoRx Mexico”), in conjunction with its Mexico-based pharmacy partner Emifarma S.A. de C.V (“Emifarma”), has successfully completed its first sample batch of Mango ED oral dissolvable tablets (ODTs) specifically to be marketed and sold in Mexico and other eligible Latin American (LATAM) countries.

These ODTs contain the Active Pharmaceutical Ingredient (API) Tadalafil and maintain the same exceptional flavor as MangoRx's other ED products. The initial batch is currently undergoing testing by a third-party U.S. laboratory to ensure consistency and quality.

“This achievement marks a significant milestone in our expansion into the Mexican and Latin American markets,” stated Jacob Cohen, MangoRx’s Co-Founder and CEO. “The successful production of our first batch of Mango ED ODTs is a testament to the dedication and expertise of our team and partners. We are committed to delivering high-quality products that meet the stringent requirements set by COFEPRIS and look forward to the next steps in this process.”

The next phase involves the production of three additional lots for bioequivalence and accelerated stability testing in Mexico, in accordance with COFEPRIS requirements. This will further pave the way for obtaining the necessary certification to begin marketing and selling Mango ED products across Mexico.

Efi Karchmer, President of MangoRx Mexico, added, “Our collaboration with Emifarma has been instrumental in achieving this milestone. Their advanced facilities and proactive approach have enabled us to move forward swiftly and confidently. We are excited about the potential to scale our business and bring our innovative ED solutions to the Mexican market and beyond.”

According to a recent market study and analysis report conducted by Groupo Knobloch, the annual market size in Mexico for ED pharmaceutical products is estimated at USD $216 million, with approximately 24 million units sold annually. This market is growing at a rate of 4% per year, with an average sales price of USD $8.50 per unit.

MangoRx is optimistic about the opportunities this presents for further expansion into other Latin American markets that recognize COFEPRIS certification, including Colombia, Ecuador, El Salvador, Chile, Costa Rica, and Panama.

About MangoRx

MangoRx is focused on developing a variety of men's health and wellness products and services via a secure telemedicine platform. To date, the Company has identified men's wellness telemedicine services and products as a growing sector and especially related to the area of erectile dysfunction (ED), hair growth and hormone replacement therapies. Interested consumers can use MangoRx’s telemedicine platform for a smooth experience. Prescription requests will be reviewed by a physician and, if approved, fulfilled and discreetly shipped through MangoRx’s partner compounding pharmacy and right to the patient’s doorstep. To learn more about MangoRx’s mission and other products, please visit www.MangoRx.com or on social media @Mango.Rx.

Cautionary Note Regarding Forward-Looking Statements 

Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws, including within the meaning of the Private Securities Litigation Reform Act of 1995 (“forward-looking statements”). These forward-looking statements represent the Company’s current expectations or beliefs concerning future events and can generally be identified using statements that include words such as “estimate,” “expects,” “project,” “believe,” “anticipate,” “intend,” “plan,” “foresee,” “forecast,” “likely,” “will,” “target” or similar words or phrases. These forward-looking statements are subject to risks, uncertainties and other factors, many of which are outside of the Company’s control which could cause actual results to differ materially from the results expressed or implied in the forward-looking statements, our ability to meet Nasdaq’s minimum bid price requirement; the Company’s stockholders’ equity as of the Company’s next fiscal quarter end; our ability to maintain the listing of our common stock on Nasdaq; our ability to commercialize our patent portfolio; our ability to obtain Comisión Federal para la Protección contra Riesgos Sanitarios for our ED product in Mexico, the costs thereof and timing associated therewith; our ability to obtain additional funding and generate revenues to support our operations; risks associated with our ED product which have not been, and will not be, approved by the U.S. Food and Drug Administration (“FDA”) and have not had the benefit of the FDA’s clinical trial protocol which seeks to prevent the possibility of serious patient injury and death; risks that the FDA may determine that the compounding of our planned products does not fall within the exemption from the Federal Food, Drug, and Cosmetic Act (“FFDCA Act”) provided by Section 503A; risks associated with related party relationships and agreements; the effect of data security breaches, malicious code and/or hackers; competition and our ability to create a well-known brand name; changes in consumer tastes and preferences; material changes and/or terminations of our relationships with key parties; significant product returns from customers, product liability, recalls and litigation associated with tainted products or products found to cause health issues; our ability to innovate, expand our offerings and compete against competitors which may have greater resources; our significant reliance on related party transactions; the projected size of the potential market for our technologies and products; risks related to the fact that our Chairman and Chief Executive Officer, Jacob D. Cohen has significant voting control over the Company; risks related to the significant number of shares in the public float, our share volume, the effect of sales of a significant number of shares in the marketplace, and the fact that the majority of our shareholders paid less for their shares than the public offering price of our common stock in our recent initial public offering; dilution caused by recent offerings; conversion of outstanding shares of preferred stock and the rights and preferences thereof, the fact that we have a significant number of outstanding warrants to purchase shares of common stock at $1.00 per share, the resale of which underlying shares have been registered under the Securities Act of 1933, as amended; our ability to build and maintain our brand; cybersecurity, information systems and fraud risks and problems with our websites; changes in, and our compliance with, rules and regulations affecting our operations, sales, marketing and/or our products; shipping, production or manufacturing delays; regulations we are required to comply with in connection with our operations, manufacturing, labeling and shipping; our dependency on third-parties to prescribe and compound our ED product; our ability to establish or maintain relations and/or relationships with third-parties; potential safety risks associated with our Mango ED product, including the use of ingredients, combination of such ingredients and the dosages thereof; the effects of changing rates of inflation and interest rates, and economic downturns, including potential recessions, as well as macroeconomic, geopolitical, health and industry trends, pandemics, acts of war (including the ongoing Ukraine/Russian conflict and war in Israel) and other large-scale crises; our ability to protect intellectual property rights; our ability to attract and retain key personnel to manage our business effectively; overhang which may reduce the value of our common stock; volatility in the trading price of our common stock; and general consumer sentiment and economic conditions that may affect levels of discretionary customer purchases of the Company’s products, including potential recessions and global economic slowdowns. Although we believe that our plans, intentions and expectations reflected in or suggested by the forward-looking statements we make in this release are reasonable, we provide no assurance that these plans, intentions or expectations will be achieved. Consequently, you should not consider any such list to be a complete set of all potential risks and uncertainties.

More information on potential factors that could affect the Company’s financial results is included from time to time in the “Cautionary Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 and our Quarterly Report on Form 10-Q for the three months ended March 31, 2024. These filings are available at www.sec.gov and at our website at https://www.mangoceuticals.com/sec-filings. All subsequent written and oral forward-looking statements attributable to the Company or any person acting on behalf of the Company are expressly qualified in their entirety by the cautionary statements referenced above. Other unknown or unpredictable factors also could have material adverse effects on the Company’s future results. The forward-looking statements included in this press release are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these statements after the date of this release, except as required by law, and takes no obligation to update or correct information prepared by third parties that are not paid for by the Company. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.

Follow Mangoceuticals and MangoRx on social media:
https://www.instagram.com/mango.rx
https://twitter.com/Mangoceuticals
https://www.facebook.com/MangoRxOfficial

FOR INVESTOR RELATIONS
Mangoceuticals Investor Relations
Email: investors@mangorx.com

SOURCE: Mangoceuticals Inc.

FAQ

What did Mangoceuticals announce on May 28, 2024?

Mangoceuticals announced the completion of its first batch of Mango ED ODTs for marketing in Mexico and Latin America.

What is the active ingredient in MangoRx's ED tablets?

The active ingredient in MangoRx's ED tablets is Tadalafil.

What is the market size for ED products in Mexico?

The ED market in Mexico is valued at $216 million annually.

What are the next steps for MangoRx's ED tablets after the first batch?

The next steps include producing three additional lots for bioequivalence and stability testing to meet COFEPRIS requirements.

Which markets is MangoRx targeting for expansion after Mexico?

MangoRx plans to expand into other Latin American markets like Colombia, Ecuador, El Salvador, Chile, Costa Rica, and Panama after obtaining COFEPRIS certification.