You should read the following discussion together with our consolidatedfinancial statements and the related notes included elsewhere in this report.This discussion contains forward-looking statements, which involve risks anduncertainties. Our actual results may differ materially from those we currentlyanticipate as a result of many factors, including the factors we describe under"Risk Factors" and elsewhere in this report.
Some of the information in this section contains forward-looking statements thatinvolve substantial risks and uncertainties. You can identify these statementsby forward-looking words such as "may," "will," "expect," "anticipate,""believe," "estimate" and "continue," or similar words. You should readstatements that contain these words carefully because they:
discuss our future expectations;
contain projections of our future results of operations or of our financial
state other "forward-looking" information.
We believe it is important to communicate our expectations. However, there maybe events in the future that we are not able to accurately predict or over whichwe have no control. Our actual results and the timing of certain events coulddiffer materially from those anticipated in these forward-looking statements asa result of certain factors, including those set forth under "Risk Factors,""Business" and elsewhere in this report.
Unless stated otherwise, the words "we," "us," "our," the "Company" or "BiotechProducts Services and Research," "Organicell" in this section collectively referto Biotech Products Services and Research, Inc., a Nevada corporation, and itssubsidiaries.
We are engaged in the health care industry, principally focusing on supplyingproducts and services related to the growing field of regenerative anti-agingmedicine ("RAAM"). Our goal is to supply newly designed advanced biologicallyprocessed cellular and tissue-based products developed from internally-basedresearch and development activities and/or from other state-of-the-artRAAM-related products developed by third parties under exclusive and/orfavorable supply arrangements and to provide other related services used in thegrowing health care field of regenerative medicine ("RAAM Products"). We intendto distribute the RAAM Products and market RAAM-related services to the healthcare industry and a referral network of doctors and clinics (collectively, the"Providers").
From November 2016 to February 2018, we began operating our own laboratoryfacilities to process and distribute RAAM Products developed through tradesecrets acquired in connection with the employment of newly hired executivesduring November 2016 and March 2017. During this time, we also implemented anin-house sales force and made arrangements with newly identified independentdistributors to sell our RAAM Products. During February 2018, we sold ortransferred our laboratory facilities and all related assets ("Sale"), includingintellectual property rights, to Vera Acquisition LLC, a Utah limited liabilitycompany ("Vera"). The Company's decision to sell the assets comprising themanufacturing operations was made mostly to mitigate the substantial ongoingoperating risks associated with the operations of the manufacturing facility,including (a) lack of adequate working capital to pay wages to key executivesand to hire additional sales and manufacturing personnel and other criticallyneeded staff and to make required payments to vendors, (b) existing and newlyissued FDA guidelines released in November 2017 governing our manufacturingoperations that were projected to require significant additional capitalresources to be deployed to satisfactorily meet regulatory requirements withinspecified deadlines.
Since the Sale was completed, including the departure of several key executives,the Company had been unsuccessful in generating sufficient revenues and as aresult continued to have a lack of working capital to meet current operatingcosts, hiring of additional sales personnel, pay past due accounts payableobligations to its vendors, pay past due and/or current salaries to itsremaining management or fund potential growth opportunities.
On April 23, 2018, the Company and Management and Business Associates, LLC, aFlorida limited liability company ("MBA"), executed a Plan and Agreement ofReorganization ("Reorganization") whereby the Company agreed to issue to MBA anaggregate of 222,425,073 shares of its common stock of the Company, representingat the time a 51% of the outstanding shares of common stock of the Company onfully-diluted basis, for $0.001 per share (or an aggregate of $222,425), inconsideration for MBA's founder and Chief Executive Officer, Mr. ManuelIglesias' agreement to serve as the Company's Chief Executive Officer and amember of the Board of the Company. The Reorganization was effective as of April13, 2018 ("Effective Date").
Prior to the execution and effectiveness of the Reorganization, Mr. Iglesiasmoved from his position as Chief Executive Officer to a position as Co-Chairmanof the Board of Hygea Holdings Corp., a Florida corporation ("Hygea"), adiversified healthcare holding company that owns physician practices, ancillaryservices companies (e.g., pharmacies, therapies and diagnostic facilities),independent physician associations ("IPAs"), and other medical service entitiesthat provide seamless care to commercial, Medicare and Medicaid patients. As thenewly appointed Chief Executive Officer of the Company, Mr. Iglesias intended tobring his extensive industry experience and relationships to attract capital andindustry leaders to the Company as the Company sought to stabilize, expand andgrow the business into becoming a leading supplier of services, products andtherapies for the regenerative health care sector, including expansion into therapidly growing wellness sector, and to pursue clinical studies andcertifications for specific disease states using the expedited United StatesFood and Drug Administration ("FDA") program for regulatory approval forregenerative medicine advance therapies ("RMAT"). As part of the Company'sefforts to raise capital, the Company initiated and/or completed severalimportant corporate governance changes to simplify the Company's capitalstructure and to attract investment capital including:
1. On May 21, 2018, the Company filed a Certificate of Amendment with the
2. On May 21, 2018, the Company filed a Certificate of Amendment with the
Secretary of State of Nevada to effectuate a reverse stock split of one (1)
new share for each seventeen (17) shares issued and outstanding as of the
record date of May 21, 2018, with resulting fractional shares being rounded up
to the nearest whole number, and a reduction in the authorized shares from 750
million to 250 million (the "Reverse Split"). On June 18, the Company filed a
Certificate of Correction with the Secretary of State of Nevada to reverse the
amendments related to the Reverse Split, and will only file a new Certificate
of Amendment with the Secretary of State of Nevada to effectuate the Reverse
Split if the Reverse Split has been effectuated in the marketplace by FINRA.
The Company believes that a Reverse Split would bring value to the issued and
outstanding shares of the Company by limiting dilution of operating results by
an excessive number of shares overhanging the market. As discussed below, the
Reverse Split has not been effectuated in the marketplace by FINRA.
3. On June 14, 2018, the Company filed a Certificate of Withdrawal with the
Secretary of State of Nevada thereby withdrawing and terminating all
previously issued designations of the Company's Series A Preferred Stock and
Series B Preferred Stock. The Company cancelled the Company's authorized and
outstanding Series A Preferred Stock and Series B Preferred Stock in order to
provide investors with greater confidence in the value to the issued and
outstanding shares of the Company by limiting dilution of operating results
and limitation on preferences granted to other investors.
4. The Company reached agreement with its key executive management in connection
5. The Company reconstituted its Board of Directors and appointed an independent
outside director. Since the Reorganization, the Company has added additional
members to its Board of Directors.
On June 1, 2018, the Company submitted an Issuer Company-Related NotificationForm ("June 1 Notification Form") with the Financial Industry Regulatory Agency("FINRA") pursuant to Rule 10b-17 of the Securities Exchange Act of 1934, asamended (the "Exchange Act"), regarding the Name Change and Reverse Split.However, due to the Company's failing to have the required Exchange Act reportsfiled with the SEC at the time of the filing, FINRA did not announce oreffectuate the Name Change or Reverse Split in the marketplace. If the Companyintends to proceed with the Name Change and/or Reverse Split, the Company willbe required to submit a new Issuer Company-Related Notification Form forapproval upon the Company becoming current in its Exchange Act filings.
During February 2019, the Company began arranging to once again operate a newlaboratory facility in Miami, Florida for the purpose of performing research anddevelopment, production and manufacturing of anti-aging and cellular therapyproducts. This new laboratory facility became operational in May 2019 and duringthe same period, the Company began producing and distributing the products thatare being sold and distributed to its customers. The Company believes that thisstrategy will provide the Company with competitive advantages and greaterassurances that it can continue to comply with expected future FDA regulations.
In connection with the Company's ongoing research and development efforts andthe Company's efforts to meet compliance with current and anticipated UnitedStates Food and Drug Administration ("FDA") regulations expected to be enforcedbeginning in November 2020 pertaining to marketing traditional biologics andhuman cells, tissues and cellular and tissue based products that fall underSection 351 of the Public Health Services Act ("HCT/Ps"), the Company appliedfor and on July 14, 2019, the Company received Institutional Review Board("IRB") approval to proceed with two pilot studies in connection with theCompany's efforts to obtain Investigation New Drug ("IND") approval from the FDAand commence clinical trials in connection with the use of the Company'sproducts and related treatment protocols for specific indications. The Companyis aggressively pursuing efforts to obtain the aforementioned IND approvals andcommence and complete those clinical studies as well as obtaining approval tocommence additional studies for other specific indications it has identifiedthat the use of its products will provide more favorable and desired healthrelated benefits for patients seeking alternative treatment options than arecurrently available. The ability of the Company to succeed in these efforts issubject to the Company having sufficient available working capital to fund thesubstantial costs, which the Company currently does not have, and ultimately theapproval from the FDA.
On September 24, 2019, due to the Company's limited success since theReorganization in stabilizing revenues and the growing urgency for the Companyto remain compliant and meet the anticipated new and more stringent regulatorydeadlines to be imposed by the FDA in connection with the Company's products andoperations that were previously announced to go into effect in November 2020,the Board determined that it would require the services of a full-time CEO withthe requisite expertise and experience to lead the Company as it (a) movesforward with its strategy to expand its research and development efforts andsubmit IND applications for FDA approval to commence clinical trials for itsproducts to assure that the Company, its operations and its products remaincompliant with FDA regulations and (b) implements additional strategies tominimize the potential impact in the future on sales of its products as a resultof future changes in FDA regulations and/or restrictions associated withclinical trials that are utilizing the products that are currently being sold bythe Company. Accordingly, the Board voted to remove Manuel Iglesias from hisposition as CEO of the Company, although he remains as non-executive Chairman ofthe Board and a director and has been offered an alternative senior managementposition with the Company. The Board also authorized management to proceed witha search for a full-time CEO and management has identified and has beguninterviewing potential candidates.
As of October 31, 2017, Mint Organics had not been successful in obtaining aFlorida license allowing Mint Organics or Mint Organics Florida to operate abusiness to dispense medical cannabis. In addition, Mint Organics had exhaustedall of its working capital and Organicell was unable to identify additionalsources of working capital.
On April 6, 2018, Mr. Taddeo resigned as a member of the Board of Directors ofthe Company and as the Chief Executive Officer and member of the Board ofDirectors of Mint Organics and Mint Organics Florida. Mr. Taddeo's resignationwas due to his decision to pursue other personal objectives, particularly inlight of the ongoing lack of adequate working capital at Mint Organics todemonstrate the ability to fund a reasonable level of future cash compensationto Mr. Taddeo and the additional capital required to sustain future effortsrequired to successfully pursue obtaining a license to operate cannabisdispensaries.
The Company had since decided that it would not pursue any additional efforts toobtain licenses to operate MMTC's. During May 2019, the Company agreed toexchange the equity held by the remaining minority interest holders of MintOrganics and Mint Organics Florida and to convert all of the outstanding debt ofMint Organics into shares of common stock of the Company.
For the years ended October 31, 2018 and 2017, our RAAM-related operations werebeing conducted through the following wholly-owned subsidiaries*:
Anu Life Sciences, Inc., a Florida corporation formed with a business purpose
General Surgical Florida, Inc., a Florida corporation with a business purpose
of selling and distributing regenerative biologic therapies based on amnion
placental tissue derived products to doctors and hospitals.
Beyond Cells Corp., a Florida corporation formed with a business purpose to
provide consumers with education regarding the field of regenerative and
anti-aging and medicine and providing access to a specialized physician network
* As described above, the manufacturing operations of ANU were sold duringFebruary 2018, and the Company subsequently relied on supply arrangements withthird-party manufacturers or indirectly from distributors of third-partymanufacturers for the supply of RAAM products that were sold to Providers duringthe period February 6, 2018 through October 31, 2018.
Our MMTC exploratory activities were conducted through the below listedsubsidiaries. Effective April 6, 2018, Mr. Taddeo resigned as CEO of our MMTCsubsidiaries. The Company had since decided that it would not pursue anyadditional efforts to obtain licenses to operate MMTC's. During May 2019, theCompany agreed to exchange the equity held by the remaining minority interestholders of Mint Organics and Mint Organics Florida and to convert all of theoutstanding debt of Mint Organics into shares of common stock of the Company**.As a result, Mint Organics, Inc. and Mint Organics Florida, Inc. are presentlyinactive and have no assets:
Mint Organics, Inc., a Florida corporation with a business purpose of operating
Medical Marijuana Treatment Centers for defined MMTC licensed activities; and
Mint Organics Florida, Inc., a Florida corporation and subsidiary of Mint
Organics with a business purpose of operating Medical Marijuana Treatment
Centers for defined MMTC licensed activities within Florida.
** Mint Organics and Mint Organics Florida had previously issued minoritynon-voting equity interests which as of May 2019 are all owned by the Company.
We also have two other wholly-owned subsidiaries that are inactive:
Ethan New York, Inc., a New York corporation formed with a business purpose of
selling clothing and accessories through a retail store in New York City
("Ethan NY") and for which operations ended in June 2016; and
BD Source and Distribution, Corp., a Florida corporation ("BD Source") formed
Current and Future Operations:
Our current strategy is to achieve the following goals and milestones:
Develop and expand operations to provide for growth of our revenues for thesales and distribution of RAAM related products;
o Increase revenues for RAAM related products;
Hiring of additional in-house sales personnel
Selectively engaging independent distributors
Marketing private label products to distributors
Increasing market recognition for our Organicell brand from:
marketing and participating in industry trade shows
o Expand our sales market outside of the United States
o Increase the number of RAAM product offerings for various modalities using
proprietary processing, formulas and administration techniques
o Extending our referral network of Providers based on:
Superior product offerings
Demonstrating a realistic and executable regulatory roadmap to assure Company
and product compliance with current and anticipated FDA regulations
Developing and providing educational support to Providers regarding our
Execute on current strategy to assure the Company's ability to maintaincompliance with existing and the anticipated changes to FDA regulationsregarding the use and sale of our current products published in November 2017and expected to take effect by November 2020, as well as readiness to respond toongoing future changes to those regulations:
o Identify qualified candidates to fill the currently vacant CEO position that
have the requisite expertise and experience to lead the Company as it moves
forward with its strategy to enhance product research and development and
execute clinical trials of the Company's products, and
o Perform clinical based studies associated with the use of our products
(independently and/or in conjunction with Providers and/or Manufacturers) and
seek accelerated approval for each product application in accordance with the
21st Century Cures Act ("Cures Act") and/or through the granting of an
FDA-approved biologics application (BLA) to allow products to be lawfully
marketed and/or sold in the United States in accordance with newly established
FDA guidelines outlined in November 2017 expected to take effect by November
2020; and
o Continue to build out our lab facilities to meet expected production and
research requirements; and
o Engage high profile and industry recognized medical advisors and scientists to
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