U.S. Securities and Exchange Commission

Washington, D.C. 20549

 

FORM 10-K

 

ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.

 

For the fiscal year ended November 30, 2020

 

TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.

 

For the transition period from        to

 

Commission File Number 000-23386

 

CRYO-CELL INTERNATIONAL, INC.

(Exact Name of registrant as specified in its charter)

 

DELAWARE

 

22-3023093

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

700 Brooker Creek Blvd, Suite 1800, Oldsmar, FL 34677

(Address of principal executive offices)     (Zip Code)

 

Registrant’s telephone number: (813) 749-2100

 

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, $0.01 par value

 

CCEL

 

OTCQB

 

 

    

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 to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes      No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post 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 definition of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

Smaller reporting company

Emerging growth company

(Do not check if a smaller reporting company)

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.  

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934).  Yes   No

 

The aggregate market value of the Registrant’s Common Stock held by non-affiliates of the Registrant is computed by reference to the price at which the common stock was last sold as of the last business day of the Registrant’s most recently completed second fiscal quarter (May 31, 2020) was $29,618,382.

 

As of February 15, 2021, there were 7,570,913 shares of Common Stock outstanding.

 

DOCUMENTS INCORPORATED BY REFERENCE

 

None.

 


TABLE OF CONTENTS

 

 

 

Page

 

PART I

 

 

FORWARD-LOOKING STATEMENTS

1

ITEM 1.

BUSINESS

1

ITEM 1A.

RISK FACTORS

12

ITEM 1B.

UNRESOLVED STAFF COMMENTS

12

ITEM 2.

PROPERTIES

12

ITEM 3.

LEGAL PROCEEDINGS

12

ITEM 4.

MINE SAFETY DISCLOSURES

13

 

 

 

 

PART II

 

ITEM 5.

MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

14

ITEM 6.

SELECTED FINANCIAL DATA

14

ITEM 7.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

15

ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

26

ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

27

ITEM 9.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

66

ITEM 9A.

CONTROLS AND PROCEDURES

66

ITEM 9B.

OTHER INFORMATION

67

 

 

 

 

PART III

 

ITEM 10.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

68

ITEM 11.

EXECUTIVE COMPENSATION

71

ITEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

78

ITEM 13.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

80

ITEM 14.

PRINCIPAL ACCOUNTANT FEES AND SERVICES

80

 

 

 

 

PART IV

 

ITEM 15.

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

82

ITEM 16.

FORM 10-K SUMMARY

84

 

SIGNATURES

85

 

 

 

 


 

Forward-Looking Statements

This Form 10‑K, press releases and certain information provided periodically in writing or orally by the Company's officers or its agents may contain statements which constitute "forward‑looking statements". The terms "Cryo-Cell International, Inc.," “Cryo-Cell,” "Company," "we," "our" and "us" refer to Cryo-Cell International, Inc. The words "expect," "believe," "goal," "plan," "intend," "estimate" and similar expressions and variations thereof, if used, are intended to specifically identify forward‑looking statements. Those statements appear in a number of places in this Form 10‑K and in other places, and include statements regarding the intent, belief or current expectations of the Company, its directors or its officers with respect to, among other things, our future performance and operating results, our future operating plans, our liquidity and capital resources; and our legal proceedings. Investors and prospective investors are cautioned that any such forward‑looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward‑looking statements as a result of various factors.

ITEM 1.

BUSINESS.

Introduction

Cryo-Cell International, Inc.  (the “Company” or “Cryo-Cell”) is a Delaware corporation that was incorporated in 1989.  The Company is organized in three reportable segments, cellular processing and cryogenic storage, with a current focus on the collection and preservation of umbilical cord blood and tissue stem cells for family use, the manufacture of PrepaCyte® CB Processing System (“PrepaCyte CB”) units, the processing technology used to process umbilical cord blood stem cells and cellular processing and cryogenic storage of umbilical cord blood stem cells for public use.  The Company, in combination with its global affiliates, currently stores nearly 500,000 cord blood and cord tissue specimens worldwide for the exclusive benefit of newborn babies and possibly other members of their families.  Founded in 1989, the Company was the world’s first private cord blood bank to separate and store stem cells in 1992.  All aspects of its U.S.-based business operations, including the processing and storage of specimens, are handled from its headquarters facility in Oldsmar, Florida.  The specimens are stored in commercially available cryogenic storage units at this technologically and operationally advanced facility.  

In recent years, utilizing its infrastructure, experience and resources derived from its umbilical cord blood stem cell business, the Company has expanded its research and development activities to develop technologies related to stem cells harvested from sources beyond umbilical cord blood stem cells.  During fiscal 2011, the Company introduced the advanced new cord tissue service, which stores a section of the umbilical cord tissue.  The Company offers the cord tissue service in combination with the umbilical cord blood service.  This service is growing; however, the umbilical cord blood service continues to be the Company’s main focus.

Consistent with its fiduciary duties, the board of directors and management has reviewed and will continue to review strategic options and opportunities for the Company, in order to maximize shareholder value.  These options may include, but are not limited to, strategic mergers or acquisitions, investments in other public and/or private companies, repurchases of RSA interests, a deregistration of the Company's common stock under the Securities Exchange Act of 1934 or a going-private transaction.   These options may or may not be related to the Company’s current business.  In order to undertake any of the aforementioned activities, the Company may take on substantial debt or equity capital which could increase the risk of investment in the Company.

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Cord Blood Stem Cell Processing and Storage Business

Background of Business

Nearly fifty years ago researchers discovered that cells could be cryopreserved at extremely low temperatures and all cellular activity would cease until the specimens were thawed.  Historically, cryopreservation was required for organ transplants, blood banking and medical research.  Today, cryopreservation of umbilical cord blood stem cells gives individuals the opportunity to potentially take advantage of evolving cellular therapies and other medical technologies.  

Hematopoietic stem cells are the building blocks of our blood and immune systems.  They form the white blood cells that fight infection, red blood cells that carry oxygen throughout the body and platelets that promote healing.  Stem cells are found in bone marrow where they continue to generate cells throughout our lives.  Stem cells can be stored in a cryogenic environment, and upon thawing, infused into a patient.  They can be returned to the individual from whom they were taken (autologous) or donated to someone else (allogeneic).  An individual's own bone marrow may be used for a transplant if the cancer has not entered the marrow system (metastasized).  Otherwise, a marrow donor needs to be identified to provide the needed bone marrow.  The availability of a marrow donor or matched stem cell specimen allows physicians to administer larger doses of chemotherapy or radiation in an effort to eradicate the disease.  Stem cell therapies and transplants are used for both cancerous and non-cancerous diseases.

Stem cells are found in umbilical cord blood ("cord blood stem cells") and can be collected and stored after a baby is born.  Over 35,000 cord blood stem cell transplants have been performed to date.  The Company believes that parents will want to save and store these cells for potential future use by their family, either for the donor or for another family member.  Moreover, researchers believe they may be utilized in the future for treating diseases that currently have no cure.

The Company believes that the market for cord blood stem cell preservation is enhanced by global discussion on stem cell research developments and the current focus on reducing prohibitive health care costs.  With the increasing costs of bone marrow matches and transplants, a newborn's umbilical cord blood cells can be stored as a precautionary measure.  Medical technology is constantly evolving which may provide new uses for cryopreserved cord blood stem cells.

Our Cord Blood Stem Cell Storage Services

The Company enters into storage agreements with its clients under which the Company charges a fee for the processing and testing and first year of storage of the umbilical cord blood.  Thereafter, the client is charged an annual fee to store the specimen, unless the client has entered into an 18-year pre-paid storage plan or a lifetime pre-paid storage plan.

The Company’s corporate headquarters are located in a nearly 18,000 square-foot state-of-the-art current Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP)-compliant facility.  Food and Drug Administration (“FDA”) 21 CFR Part 1271, effective in May 2005, requires human cellular and tissue-based products to be manufactured in compliance with good tissue practices (cGTPs).  The Company’s laboratory processing facility contains a Class 10,000 clean room and Class 100 environments for the processing of cord blood stem cells and other cellular tissues.  In addition, the cellular products cryogenic storage area has been designed as a “bunker,” with enhanced provisions for security, building fortification for environmental element protection and back-up systems for operational redundancies.  The Company believes that it was the first private bank to process cord blood in a technologically and operationally advanced cGMP/cGTP-compliant facility.  The Company’s facility, which also currently houses the Company’s client services, marketing and administrative operations, is designed to accommodate a broad range of events such as client tours and open houses, as well as educational workshops for clinicians and expectant parents.

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Competitive Advantages

The Company believes that it provides several key advantages over its competitors, including:

 

The world’s first private cord blood bank, that in combination with its global affiliates, currently stores nearly 500,000 cord blood and cord tissue specimens worldwide,

 

our status as a cGMP- and cGTP-compliant private cord blood bank with AABB accreditation and FACT (the Foundation for the Accreditation for Cellular Therapy) accreditation,

 

a state-of-the-art laboratory processing facility,

 

utilization of a processing method using superior technology that yields the maximum recovery of healthy stem cells and provides superior red blood depletion over all other methods,

 

a five-compartment cord blood freezer bag that allows for multiple uses of the baby’s cord blood stem cells,

 

a safe, secure and monitored storage environment,

 

since inception, 100% viability rate of the Company’s specimens upon thaw for therapeutic use,

 

a state-of the-art, insulated collection kit that protects cord blood specimens thirty times longer under extreme conditions than competitor’s kits,

 

7 day per week processing capability, and

 

a payment warranty under which the Company agrees to pay $50,000 (effective February 1, 2012 this payment was increased to $75,000 for new clients, effective June 1, 2017 this payment was increased to $100,000 for new clients that choose the premium cord blood processing method, PrepaCyte CB) to its client if the umbilical cord blood product retrieved is used for a stem cell transplant for the donor or an immediate family member and fails to engraft, subject to various restrictions.

Cord Tissue

In August 2011, the Company introduced its advanced new cord tissue service, which stores a section of the umbilical cord tissue.  Approximately six inches of the cord tissue is procured and transported to the Company’s laboratory for processing, testing and cryopreservation for future potential use.  Umbilical cord tissue is a rich source of mesenchymal stem cells (MSCs).  MSCs have many unique functions including the ability to inhibit inflammation following tissue damage, to secrete growth factors that aid in tissue repair, and to differentiate into many cell types including neural cells, bone cells, fat cells and cartilage. MSCs are increasingly being researched in regenerative medicine for a wide range of conditions including heart and kidney disease, ALS, wound healing and auto-immune diseases.   MSCs from several different tissues are being tested in clinical trials for efficacy. Specifically, cells derived from cord tissue are currently being used in many clinical trials. Disorders being treated include cardiomyopathy, ulcerative colitis, diabetes, anemia, autism and cirrhosis of the liver.

Public Banking

In June 2018, the Company acquired substantially all of the assets (the “Cord Purchase”) of Cord:Use Cord Blood Bank, Inc., a Florida corporation (“Cord:Use”), in accordance with  the definitive Asset Purchase Agreement between Cryo-Cell and Cord:Use (the “Purchase Agreement”),  including without limitation Cord:Use’s inventory of public cord blood units existing as of the closing date (the

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“Public Cord Blood Inventory”).  The Public Cord Blood Inventory creates a large, ethnically diverse, high quality inventory of available cord blood stem cell units for those in need of life saving therapy.  The Company collects cord blood units at hospitals in Florida, Arizona, California, Michigan and Washington.  The Company’s public inventory is stored in North Carolina, and the cord blood units are sold through the National Marrow Donor Program (“NMDP”) located in Minnesota, who ultimately distributes the cord blood units to transplant centers located in the United States, and around the world.

Marketing

Marketing Approach

It is the Company’s mission to inform expectant parents and their prenatal care providers of the potential medical benefits from preserving stem cells and to provide them the means and processes for collection and storage of these cells.  Today, stem cell transplants are known and accepted treatments for approximately 80 diseases, a number of them life-threatening.  With continued research in this area of medical technology, other therapeutic uses for cord blood stem cells are being explored.  A vast majority of expectant parents are simply unaware that umbilical cord blood contains a rich supply of non-controversial stem cells and that they can be collected, processed and stored for the potential future use of the newborn and possibly related family members.  A baby’s stem cells are a perfect match for the baby throughout its life and have a 1-in-4 chance of being a perfect match and a 3-in-4 chance of being an acceptable match for a sibling.  There is no assurance, however, that a perfect match means the cells could be used to treat certain diseases of the newborn or a relative.  Today, it is still common for the cord blood (the blood remaining in the umbilical cord and placenta) to be discarded at the time of birth as medical waste.

Despite the potential benefits of umbilical cord blood stem cell preservation, the number of parents of newborns participating in stem cell preservation is still relatively small compared to the number of births (four million per annum) in the United States.  Some reasons for this low level of market penetration are the misperception of the high cost of stem cell storage and a general lack of awareness of the benefits of stem cell preservation programs.  However, evolving medical technology could significantly increase the utilization of the umbilical cord blood for transplantation and/or other types of treatments.  The Company believes it offers the highest quality, highest value service targeted to a broad base of the market.  We intend to maximize our growth potential through our superior quality, value-driven competitive leadership position, product differentiation, an embedded client base, increased public awareness and accelerated market penetration.

Umbilical Cord Blood and Cord Tissue Services

The Company markets its cord blood stem cell preservation services directly to expectant parents and by distributing information through obstetricians, pediatricians, childbirth educators, certified nurse-midwives and other related healthcare professionals.  The Company believes that its revenues have been facilitated by a variety of referral sources, resulting from high levels of customer satisfaction.  New expectant parent referrals during fiscal 2020 were provided by physicians, midwives and childbirth educators, and by client-to-client referrals and repeat clients storing the stem cells of their additional children.  

The Company has a national sales force to increase its marketing activities with its clinical referral sources, including physicians, midwives and hospitals.  Promotional activities also include advertisements in clinical journals and telemarketing activities.  In addition, the Company exhibits at conferences, trade shows and other meetings attended by medical professionals.  Significant portions of client referrals to the Company are from medical caregiver professionals.

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To increase awareness among expectant parent audiences, the Company continues to promote its service through internet marketing.  Expectant parents have also received information via emails and internet marketing campaigns.

The Company’s client support team advisors are available by telephone to enroll clients and educate both expectant parents and the medical community on the life-saving potential of cord blood stem cell preservation.

The Company continues to use its website, www.cryo-cell.com, to market its services and to provide resource information to expectant parents.   The site, which is frequently updated and improved, is divided into areas of interest, including sections for expectant parents, medical caregivers and investors.  Expectant parents may request and receive information about the umbilical cord blood and cord tissue service and enroll online.  Viewers may read about successful transplants using Cryo-Cell stored cord blood stem cells and access other topical information.  Information on our website is not incorporated into this Annual Report on Form 10-K and should not be considered part of this Annual Report on Form 10-K.

Competition

Growth in the number of families banking their newborn’s cord blood stem cells has been accompanied by an increasing landscape of competitors.  The Company competes against approximately 25 other national private cord blood banks.  

Some of these competitors may have access to greater financial resources.  Nevertheless, the Company believes it is currently well positioned to compete in the industry.  Importantly, the Company believes that some competitors charge more for comparable (or even inferior) quality service.  In addition, the Company possesses an industry-recognized AABB accreditation, and believes that it was the first private cord blood bank to process in a cGMP- and cGTP-compliant facility exceeding current FDA requirements.  During 2014, the Company was granted FACT (the Foundation for the Accreditation for Cellular Therapy) accreditation.  These achievements position Cryo-Cell as an industry quality leader as a cGMP- and cGTP-compliant private cord blood bank with ISO certification, AABB and FACT accreditations.  

The Company believes that its longevity and experience; value-based pricing strategy; superior customer service; premier technical and operational expertise; state-of-the-art facilities; innovative marketing programs and its expansive client base will continue to provide a competitive advantage.  

Government Regulation

The Company is required to register with the FDA under the Public Health Service Act because of its ongoing cellular storage business and is subject to FDA inspection.  This requirement applies to all establishments engaged in the recovery, processing, storage, labeling, packaging, or distribution of any Human Cells, Tissues, and Cellular and Tissue-Based Products (“HCT/Ps”) or the screening or testing of a cell or tissue donor. In addition, with the purchase of the manufacturing rights to the PrepaCyte CB Processing System on June 30, 2015, Cryo-Cell is required to register this product as a Medical Device under the Federal Food, Drug, and Cosmetic Act which is also subject to FDA inspection.  At November 30, 2020 and November 30, 2019, the Company was in compliance with these requirements.

The division of FDA which regulates HCT/Ps is the Center for Biologics Evaluation and Research (“CBER”).  The section of FDA Code of Federal Regulations (“CFR”) pertaining to cord blood is 21 CFR 1271.  Since 2004, the FDA has formulated a “Tissue Action Plan” which consists of these three rules:

 

1.

As of January 21, 2004, all cord blood banks are required to register with the FDA.  Any cord blood bank which has a laboratory should be on the web page of FDA Registered Establishments.

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2.

The second rule was published May 20, 2004, and became effective May 25, 2005.  It pertains to donor eligibility.  This rule requires more screening of donors for communicable diseases.

 

3.

The final rule establishes FDA standards of current Good Tissue Practice (“GTP”) for laboratories which process HCT/Ps.  This rule was published November 19, 2004, became effective May 25, 2005, and is intended to prevent contamination or cross-contamination during the handling of HCT/Ps.

These three FDA rules apply only to cord blood processed on or after the effective date of May 25, 2005.  The final rule allows the FDA to inspect cord blood laboratories to determine compliance with the provisions of 21 CFR Part 1271.  As part of this oversight authority, the FDA conducts unannounced inspections of cord blood banks.

Upon execution of the acquisition of all of the assets of Cord:Use, the Company acquired the cord blood operations which included both public (PHS 351) and private (PHS 361) banks. The Company closed the Cord:Use location and maintains its operations in Oldsmar, FL. The new PHS 351 product is distributed under an IND (10-CBA) maintained by the National Marrow Donor Program (NMDP). The Company has continued the contract with Duke University initiated by Cord:Use to manufacture, test, cryopreserve, store and distribute the public cord blood units. The units are listed on the NMDP Single Point of Access Registry and are available to transplant centers worldwide.  The Company is reimbursed via cost recovery for public cord blood units distributed for transplant through the NMDP. The donation of cord blood units in the public cord blood banking program functions under The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Company adheres to HIPAA rules.  The FDA does not require establishments that manufacture drugs (including biological products) and devices that are HCT/Ps for use under an investigational new drug application (IND) (21 CFR Part 312) to register and list their HCT/Ps until the HCT/P is approved through a biologics license application (BLA), new drug application (NDA), or premarket approval application (PMA); or cleared through a premarket notification submission (510(k)).

The PrepaCyte CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total nucleated cells (TNC) from human umbilical cord blood, prior to banking.  The device is composed of three integrally attached processing and storage containers (or a single processing container) with separation media. The system is 510K cleared as a Class II device. The division of the FDA which regulates this product is the Center of Biologics Evaluation and Research (“CBER”). Approval to market the device was determined by the Office of Cellular, Tissue and Gene Therapies. The section of FDA Code of Federal Regulations (“CFR”) pertaining to medical device is 21 CFR 800s. The requirements for compliance to this section include annual registration of the device, listing of devices with the FDA, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Currently, the states of California, Illinois, Maryland, New Jersey and New York require cord blood banks to be registered or licensed.  The Company is currently registered or licensed to operate in these states.  If the Company identifies other states with licensing requirements or if other states adopt such requirements, the Company would have to obtain licenses or registration to continue providing cord blood services in those states.

Federal and state laws govern the Company’s ability to obtain and, in some cases, to use and disclose data that we may need to conduct certain activities.  The HIPAA requires the Department of Health and Human Services to issue a series of regulations establishing standards for the electronic transmission of certain health information.   The Company’s private cord blood bank operation is not subject to HIPAA because the Company does not engage in certain electronic transactions related to the reimbursement of healthcare providers and because blood and tissue procurement and banking activities are exempt.  However, the healthcare providers that collect umbilical cord blood for the Company’s customers are subject to HIPAA.  The identifiable information shared is only what is permitted by HIPAA.  In 2009, a portion of the American Recovery and Reinvestment Act of 2009 modified HIPAA under the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”).  While the Company is

6


still not subject to HIPAA for the reasons stated above the Company may incur material expenses associated with compliance efforts.  In addition, compliance may require management to spend substantial time and effort on compliance measures.  If the Company fails to comply with HIPAA, it could suffer criminal and civil penalties.  The civil penalties could include monetary penalties ranging from $100 per violation to $1.5 million depending on the level of violation.

The Company is also subject to local, state and federal laws and regulations relating to safe working conditions, laboratory and manufacturing practices and the use and disposal of hazardous or potentially hazardous substances.  These laws include the Occupational Safety and Health Act (“OSHA"), cGTPs, cGMPs, Environmental Protection Act and those of the local Department of Health.

OSHA requires all employers to assure safe and healthful working conditions for working men and women through development and implementation of work standards, education, and training. OSHA enforces the standards developed under the Act, applicable to all employers in the U.S. and its territories. cGTPs are laws, enforced by the FDA, that define and govern methods used in the manufacture of Human Cells, Tissues, and cellular and tissue-based Products (HCT/Ps).  Current Good Manufacturing Practices (cGMPs) are laws, enforced by the FDA, that define and govern methods used in the manufacture of drugs and finished pharmaceuticals.  Both of the latter federal practices, or laws, govern the Company’s products.

The Environmental Protection Agency (EPA) governs the management and proper disposal of products and by-products or waste.  These products must be disposed in a manner that does not adversely affect the environment from which it came or where disposed of.  The Department of Health on the local level primarily regulates systems and associated equipment employed in recovery activities such as back-up generators; therefore, governing specific internal processes.

Evolving legislation and regulations governing private cord blood banking in various jurisdictions throughout the world may impact the Company’s international licensees.

In addition, as the organization grows and evolves, other legislation and regulations are expected to impact the Company.  One such evolution involves activities that may be designated as or involve medical research or cooperative agreements associated with medical research.  These types of activities are also governed by the FDA, specifying oversight by an Institutional Review Board (IRB).  The IRB is a board or committee that approves the initiation of, and conducts periodic review of, biomedical research involving human subjects.  The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.  Governance of biomedical research is codified as laws by Title 21 of the Code of Federal Regulations (CFR) Part 56, and enforced by the FDA. Other medical research associated with clinical trials may require an Investigational New Drug Application (IND).  Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines.  Because a sponsor will likely want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement.  The IND is the means through which the sponsor technically obtains this exemption from the FDA.  This approval would be required in the case of a clinical trial.

Patent Option Agreement with Duke University

Effective June 9, 2020, the Company entered into a Patent Option Agreement (the “Option”) with Duke University (“Duke”). The Option grants Cryo-Cell the exclusive option to obtain an exclusive license to certain of Duke’s patent rights to make, have made, use, import, offer for sale, sell and otherwise commercially exploit (with the right to sublicense) certain licensed products and to practice certain licensed processes, and the exclusive right to use certain regulatory data and technical information in connection with such licensed patent rights, in the treatment, prevention, cure, reduction, mitigation or other management of diseases in humans, except, with regard to certain patent rights, in certain excluded fields of use and in certain territories, as well as a limited license to make, have made or use certain products, processes, data and information for the purpose of evaluating the market potential for such products and

7


processes in the designated field of use, subject to Duke’s reserved rights to practice the licensed rights for all research, public service, internal (including clinical) and/or educational purposes. This exclusive Option is for a period of six months from the effective date of the Option. As consideration for the Option, the Company paid Duke a non-refundable, option fee of $350,000 during June 2020. The Option was subject to extension by the Company for an additional six months by payment of $150,000 on or before the expiration of the initial six-month option period. On December 1, 2020, the Company made the extension payment of $150,000.  Such option fee, plus the extension fee, will be fully credited against the license fee under the future license agreement. In connection with the option, Cryo-Cell anticipates opening a clinic to help patients have greater access to cord blood treatments established by Duke University under the FDA granted Expanded Access Program.

On February 23, 2021, the Company entered into a Patent and Technology License Agreement (the “Agreement”) with Duke, pursuant to which Duke has granted to the Company an exclusive license to make, have made, use, import, offer for sale, sell and otherwise commercially exploit (with the right to sublicense) certain licensed products and to practice certain licensed processes, and the exclusive right to use certain regulatory data and technical information in connection with such licensed patent rights, in the treatment, prevention, cure, reduction, mitigation or other management of certain diseases in humans, except, with regard to certain patent rights, in certain excluded fields of use and in certain territories, subject to Duke’s reserved rights to practice the licensed rights for all research, public service, internal (including clinical) and/or educational purposes.  

The Agreement extends until expiration of the last Royalty Term, unless sooner terminated as provided in the Agreement. Royalty Term generally means the period beginning on the first commercial sale of each licensed product or licensed process and ending fifteen (15) years thereafter. Upon expiration of the applicable Royalty Term with respect to a particular licensed product or licensed processes, the licenses and rights granted by Duke to the Company under the Agreement with respect to such product or process become fully paid-up, royalty-free, perpetual and irrevocable.

The Company is required to pay Duke a license fee equal to $12,000,000, of which $5,000,000 must be paid within fourteen (14) days of February 23, 2021 (of which $500,000 has previously been paid through the crediting of the previously paid $350,000 option fee plus $150,000, extension fee, as described above), $5,000,000 must be paid on the first anniversary of February 23, 2021, and $2,000,000 must be paid on the second anniversary of February 23, 2021.  In addition, during the Royalty Term, subject to certain minimum royalties, the Company is required to pay Duke royalties based on a portion of the net sales varying from 7% - 12.5% based on volume.

 

The Company is also required to pay Duke minimum annual royalties beginning on the second anniversary of the effective date.  The minimum royalties are as follows:

 

Year 2: $500,000

 

Year 3: $1,000,000

 

Year 4: $2,500,000

 

Year 5 and each year thereafter during the term of this Agreement: $5,000,000

 

In addition, the Company is required to pay Duke certain milestone payments, as follows:

 

 

Two Million Dollars ($2,000,000) upon initiation of the first Phase III clinical trial for an indication other than Autism Spectrum Disorder, for a licensed product comprising cord tissue; and

 

 

a number of shares of the Company’s common stock equal to the corresponding percentage of the Company’s fully-diluted equity ownership outstanding as of February 23, 2021 as follows:  

 

(1)

5.0% upon execution of the Agreement;

 

(2)

2.5% upon cumulative net sales of licensed product and licensed process of $10,000,000;

 

(3)

2.5% upon cumulative net sales of licensed product and licensed process of $75,000,000

8


 

 

(4)

2.5% at each of the following market cap of the Company (based on a rolling 30-day average closing market cap) triggers:

 

o

Equal to or greater than $300,000,000, provided such trigger occurs within eighteen (18) months of February 23, 2021; and

 

o

Equal to or greater than $500,000,000, provided such trigger occurs within twenty-four (24) months of February 23, 2021.

Subsidiaries and Joint Ventures

Since its inception, Cryo-Cell has entered into a number of business activities through subsidiaries and joint ventures, including the following activities and those described under “International” below. The Company continues to evaluate and pursue, certain opportunities for global expansion, on a selective basis, in which operational synergies and economic potential align with Cryo-Cell’s strategic direction.

Saneron CCEL Therapeutics, Inc. (“Saneron”). Saneron is the owner and/or exclusive licensee of certain technology developed by and/or in collaboration with the University of South Florida and the University of Minnesota.  The technology covers various patents, patent applications and trade secrets for the therapeutic use of umbilical cord blood stem cells (U-CORD-CELL®) and Sertoli cells (SERT-CELL™).  As of November 30, 2020, and November 30, 2019, the Company had an ownership interest of approximately 33% in Saneron which is accounted for under the equity method.  As of November 30, 2020, and November 30, 2019, the net Saneron investment, which represents underlying goodwill, is reflected on the consolidated balance sheets at $0.

Revenue Sharing Agreements (“RSAs”)

The Company entered into RSAs prior to 2002 with various third and related parties.  The Company’s RSAs provide that in exchange for a non-refundable up-front payment, the Company would share for the duration of the RSA a percentage of its future revenue derived from the annual storage fees related to a certain number of specimens that originated from specific geographical areas.  The RSAs have no definitive term or termination provisions.  The sharing applies to the storage fees collected for all specified specimens in the area covered by the RSA up to the number covered in the RSA.  When the number of specimens is filled, any additional specimens stored in that area are not subject to the RSA.  As there are empty spaces resulting from attrition, the Company agrees to fill them as soon as possible.  The Company reflects these up-front payments as long-term liabilities on the accompanying consolidated financial statements.  The Company does not intend to enter into additional RSAs.

In the future, the Company could reverse the liability relating to the RSAs up-front payments over an appropriate period of time, based on the Company’s expectations of the total amount of payments it expects to pay to the other party under the particular RSA.  However, the RSAs do not establish a finite term or time frame over which to estimate the total payments and the Company had not previously estimated and has concluded that it is not currently practicable to estimate the projected cash flows under the RSAs.  At present, the Company intends to defer the reversal of the liability, until such time as these amounts can be determined.  During the periods when the Company defers the reversal of the liability, the quarterly payments made during these periods are treated as interest expense, which is recognized as the payments become due.  In future periods, if a portion of the liability can be de-recognized based on the effective interest method, the payments will be allocated between interest and amortization of the liability.  As cash is paid out to the other party during any period, the liability would be de-recognized based on the portion of the total anticipated payouts made during the period, using the effective interest method.  That is, a portion of the payment would be recorded as interest expense, and the remainder would be treated as repayment of principal, which would reduce the liability.

Florida.  On February 9, 1999, the previous Arizona RSAs were modified and replaced by an RSA for the state of Florida for a price of $1,000,000.  During fiscal 2016, 50% of the RSA for the state of Florida was repurchased by the Company.  The RSA applies to net storage revenues originating from specimens

9


from within the state of Florida less a deduction for billing and collection fees.  The RSA entitles the investors to revenues of up to a maximum of 33,000 storage spaces.  

Texas.  On May 31, 2001, the Company entered into an RSA with Red Rock Partners, an Arizona general partnership, entitling them to on-going shares in a portion of the Company’s net storage revenue generated by specimens originating from within the state of Texas for a price of $750,000.  The investors are entitled to a 37.5% share of net storage revenues less a deduction for billing and collection fees for specimens originating in the state of Texas to a maximum of 33,000 storage spaces.  During fiscal 2008, Red Rock assigned 50% of their interest in the agreement to SCC Investments, Inc., an Arizona corporation.  Subsequent to November 30, 2009, SCC Investments, Inc. assigned its interest to SCF Holdings, LLC, an Arizona limited liability company.  During fiscal 2016, 50% of the RSA for the state of Texas was repurchased by the Company.

Illinois.  In 1996, the Company entered into an RSA with a group of investors (the “Erie Group”) entitling them to an on-going 50% share of the Company’s 75% share of the annual storage fees (“net storage revenues”) less a deduction for 50% of billing and collection expenses generated by specimens stored in the Illinois Masonic Medical Center for a price of $1,000,000.  The RSAs were modified in 1998 to broaden the covered specimens to those originating in Illinois and its contiguous states and stored in Oldsmar, Florida for a maximum of up to 33,000 storage spaces.  

On August 31, 2020 (the “Effective Date”), the Company entered into a Termination Agreement (“Termination Agreement”) with the Erie Group, pursuant to which all such parties terminated all of their respective rights, duties, obligations, options, and liabilities to each other arising out of or related to the Cryo-Cell International, Inc. Space and Time Sharing (SATS) Lease Agreement, Addendum thereto, Addition to such Addendum, and Amendment to the Cryo-Cell International, Inc. Space and Time Sharing (SATS) Lease Agreement among the Company and the Erie Group (collectively, the “SATS Agreement”). The SATS Agreement is the RSA entered into with the Erie Group.  Additionally, pursuant to the terms of the Termination Agreement, the Company made a payment of $1,939,748 on the Effective Date and the parties released each other from all claims related to the SATS Agreement and to dismiss with prejudice the previously disclosed complaint (See Note 12).  Pursuant to the terms of the Agreement, the Erie Group will no longer have the rights to share in a portion of the Company’s storage revenues derived from specimens which originated in the state of Illinois and its five contiguous states. The payment amount of $1,939,748 was offset by the carrying amount of the long-term liability related to the SATS in the amount of $550,000 and accrued expenses in the amount of $279,100 to reflect the extinguishment of revenue sharing agreements in the amount of $1,070,900 for the twelve months ended November 30, 2020.

The Company made total payments to all RSA holders of $974,276 and $832,587 for the fiscal years ended November 30, 2020 and 2019, respectively.  The Company recorded an RSA accrual of $762,573 and $909,765 as of November 30, 2020 and 2019, respectively, related to interest owed to the RSA holders, which is included in accrued expenses.  The Company also recorded interest expense of $1,148,592 and $944,060 for the fiscal years ended November 30, 2020 and 2019, respectively, which is reflected in interest expense on the accompanying consolidated statements of comprehensive income.

International

The Company enters into two types of licensing agreements and in both types, the Company earns revenue on the initial license fees.  Under the technology agreements, the Company earns processing and storage royalties from the affiliates that process in their own facility.  Under the marketing agreements, the Company earns processing and storage revenues from affiliates that store specimens in the Company's facility in Oldsmar, Florida.

10


Technology Agreements

The Company has entered into a definitive License and Royalty Agreement with LifeCell International Private Limited, formerly Asia Cryo-Cell Private Limited, (“LifeCell”) to establish and market its umbilical cord blood and menstrual stem cell programs in India.

Per the License and Royalty Agreement with LifeCell, there is a $1,000,000 cap on the amount of royalties due to the Company per year and a $10,000,000 cap on the amount of royalties due to the Company for the term of the License and Royalty Agreement.  The cap(s) are calculated based on LifeCell’s fiscal year end, March 31st.  As of the end of the Company’s fiscal year ended November 30, 2020, the Company had reached the $10,000,000 cap and recorded the remaining $629,702 due.  As of the end of the Company’s fiscal year ended November 30, 2019, LifeCell had reached the $1,000,000 cap.  Since inception of the License and Royalty Agreement, the Company has recorded $10,000,000 in royalty income due under the terms of the License and Royalty Agreement, of which, LifeCell has paid the Company $8,900,000 as of November 30, 2020.  The balance of $1,100,000 is reflected as Accounts Receivable on the accompanying consolidated balance sheets.  

The following table details the processing and storage royalties earned for the technology agreements for fiscal years 2020 and 2019.  The initial license fees and processing and storage royalties are reflected in licensee income in the accompanying consolidated statements of comprehensive income.

 

 

 

For the fiscal years ended November 30,

 

 

 

2020

 

 

2019

 

 

 

License

Fee

 

 

Process

and

Storage

Royalties

 

 

Total

 

 

License

Fee

 

 

Process

and

Storage

Royalties

 

 

Total

 

India

 

$

 

 

$

629,702

 

 

$

629,702

 

 

$

 

 

$

1,000,000

 

 

$

1,000,000

 

Total

 

$

 

 

$

629,702

 

 

$

629,702

 

 

$

 

 

$

1,000,000

 

 

$

1,000,000

 

 

Marketing Agreements

The Company has definitive license agreements to market the Company's umbilical cord blood stem cell programs in Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama and Pakistan.  

Employees  

At November 30, 2020, the Company had 89 full-time employees and 9 part-time employees on the staff of the Company.  Additional employees and staff will be hired on an "as needed" basis.  The Company believes its relationship with its employees is good.  None of our employees are members of any labor union, and we are not a party to any collective bargaining agreement.

11


ITEM 1A.

RISK FACTORS.

Not applicable.

ITEM 1B.

UNRESOLVED STAFF COMMENTS.

None.

ITEM 2.

PROPERTIES.

The Company entered into a ten-year lease in April 2004 for its 17,600-square foot cGMP/cGTP compliant corporate headquarters in Oldsmar, Florida.  The lease effectively commenced during October 2004, and the Company moved into this facility in November 2004.  This facility contains the Company’s executive offices, its conference and training center, its laboratory processing and cryogenic storage facility and its scientific offices.  In July 2018, the Company extended the main lease through December 31, 2021 for the 17,600 square foot space.  

The Company entered into a one-year lease in November 2013 for an additional 800 square feet of office space in Miami, Florida for annual rent of approximately $38,000.  The lease commenced during December 2013.  In December 2016, the Company extended the lease through December 31, 2019.

Rent charged to operations was $318,587 and $322,984 for the fiscal years ended November 30, 2020 and 2019, respectively, and is included in cost of sales and selling, general and administrative expenses in the consolidated statements of comprehensive income.

The future minimum rental payments under the current operating lease are as follows:

 

Fiscal Year Ending November 30,

 

Rent

 

2021

 

$

224,928

 

2022

 

$

18,744

 

 

On January 11, 2021, subsequent to the balance sheet date, the Company extended the main lease through December 31, 2024 for the 17,600 square foot space.

ITEM 3.

LEGAL PROCEEDINGS.

On December 3, 2015, a complaint styled Gary T. Brotherson, M.D., et al. v. Cryo-Cell International, Inc., Case No. 15-007461-CI, Circuit Court, Sixth Judicial Circuit, Pinellas County, Florida, was served on the Company, naming it as defendant and alleging, among other things, that the Company breached certain agreements with plaintiffs and seeking damages in excess of $15,000, the jurisdictional amount of the court in which the action is pending.  On January 12, 2016, the Company served its answer, affirmative defenses, and counterclaim against the plaintiffs.  

On August 31, 2020 (the “Effective Date”), Cryo-Cell International, Inc. (the “Company”) entered into a Termination Agreement (“Termination Agreement”) with the Erie Group (the “Erie Group”), pursuant to which all such parties terminated all of their respective rights, duties, obligations, options, and liabilities to each other arising out of or related to the Cryo-Cell International, Inc. Space and Time Sharing (SATS) Lease Agreement, Addendum thereto, Addition to such Addendum, and Amendment to the Cryo-Cell International, Inc. Space and Time Sharing (SATS) Lease Agreement among the Company and the Erie Group (collectively, the “SATS Agreement”). Additionally, pursuant to the terms of the Termination Agreement, the Company made a payment of $1,939,748 on the Effective Date and the parties released each other from all claims related to the SATS Agreement and dismissed with prejudice to the complaint referenced above, styled Gary T. Brotherson, M.D., et al. v. Cryo-Cell International, Inc., Case No. 15-007461-CI, Circuit Court, Sixth Judicial Circuit, Pinellas County, Florida, was served on the Company. Pursuant to the terms of the Agreement, the Erie Group will no longer have the rights to share in a portion of the

12


Company’s storage revenues derived from specimens which originated in the state of Illinois and its five contiguous states.

In addition, from time to time the Company is subject to proceedings, lawsuits, contract disputes and other claims in the normal course of its business.  The Company believes that the ultimate resolution of current matters should not have a material adverse effect on the Company’s business, consolidated financial position or results of operations.  It is possible, however, that there could be an unfavorable ultimate outcome for or resolution of any such claim, which could be material to the Company’s results of operations for a particular quarterly reporting period.  Litigation is inherently uncertain and there can be no assurance that the Company will prevail.  The Company does not include an estimate of legal fees and other related defense costs in its estimate of loss contingencies.

ITEM 4.

MINE SAFETY DISCLOSURES  

Not Applicable

13


PART II

ITEM 5.

MARKET FOR THE REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.

The Company's common stock is quoted on the OTC Pink Marketplace under the symbol “CCEL”.  The following table shows, for the fiscal quarters indicated, the high and low closing bid quotations for the Company's common stock as reported by Yahoo Finance.  The quotations represent inter-dealer prices without retail mark-up, markdown or commission and may not necessarily represent actual transactions.

 

Quarter Ended

 

Low Closing Bid

 

 

High Closing Bid

 

February 28, 2019

 

 

6.67

 

 

 

7.99

 

May 31, 2019

 

 

6.40

 

 

 

8.04

 

August 31, 2019

 

 

7.45

 

 

 

8.23

 

November 30, 2019

 

 

7.08

 

 

 

8.90

 

 

 

 

 

 

 

 

 

 

February 28, 2020

 

 

6.55

 

 

 

7.82

 

May 31, 2020

 

 

5.50

 

 

 

7.87

 

August 31, 2020

 

 

6.15

 

 

 

9.55

 

November 30, 2020

 

 

6.60

 

 

 

8.24

 

 

The Company has not declared any cash dividends on its common stock and has no plans to do so in the immediate future.

As of November 30, 2020, the Company had 156 shareholders of record, and management believes there are approximately 1,500 additional beneficial holders of the Company’s common stock.

The following table sets forth as of November 30, 2020, the Company’s equity compensation plans approved by shareholders.  At such date the Company had no equity compensation plans that had not been approved by shareholders.

 

Equity Compensation plans approved by stockholders

 

Number of

securities to

be issued

upon

exercise of

outstanding

options,

warrants,

rights and

issued

restricted

shares

 

 

Weighted-

average

exercise

price of

outstanding

options,

warrants

and rights

 

 

Number of

securities

remaining

available for

future

issuance

under equity

compensation

plans

(excluding

securities

reflected

in the first

column)

 

Cryo-Cell International, Inc. 2006 Stock Incentive Plan

 

 

305,000

 

 

$

2.78

 

 

 

 

Cryo-Cell International, Inc. 2012 Stock Incentive Plan

 

868,443

 

 

$

4.05

 

 

562,310

 

Total

 

1,173,443

 

 

$

3.72

 

 

562,310

 

 

ITEM 6.

SELECTED FINANCIAL DATA

Not Applicable.

14


ITEM 7.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The following discussion and analysis of the financial condition and results of operations of the Company for the two years ended November 30, 2020, should be read in conjunction with the consolidated financial statements and related notes as well as other information contained in this Annual Report on Form 10-K. This section of the Form 10-K contains forward-looking statements that involve substantial risks and uncertainties, such as statements about our plans, objectives, expectations and intentions. We use words such as “expect”, “anticipate”, “plan”, “believe”, “seek”, “estimate”, “intend”, “future” and similar expressions to identify forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Form 10-K.

Overview

The Company is engaged in cellular processing and cryogenic storage, with a current focus on the collection and preservation of umbilical cord blood stem cells for family use.  The Company’s principal sources of revenues are service fees for cord blood processing and preservation for new customers and recurring annual storage fees.  Effective April 2016, the Company offers two pricing models, a standard plan and premium plan.  The Company charges fees of $1,675 for the standard plan and $2,025 for the premium plan to new clients for the collection kit, processing, testing and return medical courier service, with discounts in the case of multiple children from the same family and in other circumstances.  The Company charges an annual storage fee of $175 for new clients that enroll in the standard and premium plans; storage fees for existing customers depend on the contracts with such customers.  The Company continues to offer a one-time payment plan for 18 years of storage and a lifetime payment plan, pursuant to which the client is charged $4,650 for the standard plan and $5,000 for the premium plan and approximately $5,800 for the standard plan and approximately $6,100 for the premium plan, respectively, less discounts in the case of multiple children from the same family and in other circumstances.  The one-time plan includes the collection kit, processing and testing, return medical courier service and 18 years of prepaid storage fees.  The lifetime plan includes the collection kit, processing and testing, return medical courier service and prepaid storage fees for the life of the client.  The Company also receives other income from licensing fees and royalties from global affiliates.

On June 11, 2018, Cryo-Cell completed its acquisition of substantially all of the assets (the “Cord Purchase”) of Cord:Use Cord Blood Bank, Inc., a Florida corporation (“Cord:Use”), in accordance with  the definitive Asset Purchase Agreement between Cryo-Cell and Cord:Use (the “Purchase Agreement”),  including without limitation Cord:Use’s inventory of public cord blood units existing as of the closing date (the “Public Cord Blood Inventory”) and Cord:Use’s shares of common stock of Tianhe Stem Cell Biotechnologies, Inc., an Illinois corporation (the “Tianhe Capital Stock”). Cord:Use was in the business of public and private cord blood and tissue, collection, processing, storage and banking.  The aggregate consideration payable at closing under the Purchase Agreement was $14,000,000, with $10,500,000 paid in cash and the balance paid through the delivery to Seller of 465,426 shares of Cryo-Cell’s common stock, par value $0.01 per share (“Common Stock”), at $7.52 per share. In addition, Cryo-Cell assumed certain limited liabilities incurred by Cord:Use in connection with its business that were unpaid as of the closing date and that directly relate to the services to be provided after closing by Cryo-Cell. Cryo-Cell also assumed certain of Cord:Use’s contracts and the obligations arising therefrom after the closing.   Additionally, Cord:Use is entitled to an earnout from Cryo-Cell’s sale of the Public Cord Blood Inventory from and after closing.  Each calendar year after the closing, Cryo-Cell is required to pay to Cord:Use 75% of all gross revenues, net of any returns, received from the sale of public cord blood inventory in excess of $500,000.  Such payments are to be made quarterly, within 30 days of the end of the last month of each calendar quarter, until the public cord blood inventory is exhausted.  In addition, each calendar year after closing, until the public cord blood inventory is exhausted, for every $500,000 of retained gross revenues, net of any returns, received and retained by Cryo-Cell in excess of the initial $500,000 retained by Cryo-Cell during such year,

15


Cryo-Cell is to deliver $200,000 worth of Cryo-Cell Common stock to Cord:Use, up to an aggregate value of $5,000,000.  Cord:Use is also entitled to a portion of the gross profits generated, or deemed to have been generated, by Cryo-Cell from its ownership of the Tianhe Capital Stock.

During the fiscal year ended November 30, 2020, the Company’s total revenue decreased 2% as compared to fiscal 2019.  The Company reported net income of approximately $3,625,000, or $0.48 per basic common share and $0.45 per diluted share for fiscal 2020 compared to net income of approximately $2,291,000, or $0.29 per basic and $0.27 per diluted common share for fiscal 2019.  Net income for the twelve months ended November 30, 2020 principally resulted from 4% decrease in cost of sales, a 4% decrease in selling, general and administrative expenses, a 161% decrease in the Contingent Consideration (described below) and by a 2% decrease in revenue.  Also included in the net income for the twelve months ended November 30, 2020 and November 30, 2019 was an impairment charge of $1,284,238 and $2,332,763, respectively.  Due to changes in sales trends and estimated recoverability of cost capitalized into inventory, an impairment charge was recognized during the fourth quarter of fiscal 2020 and the second quarter of fiscal 2019, respectively, to reduce inventory from cost to net realizable value.

As of November 30, 2020, the Company had cash and cash equivalents of $10,361,125.  The Company’s cash increased by approximately $3,800,000 during fiscal 2020.  Cash provided by operations was approximately $8,467,000 and cash provided due to the liquidation of marketable securities was $807,447 (see Note 1), which were offset by approximately $100,000 used for the purchase of property and equipment, $350,000 paid to Duke as part of the Patent Option Agreement (see Note 19), $1,900,000 toward the termination of a revenue sharing agreement (see Note 14) and approximately $3,100,000 used to repay the note payable with Texas Capital Bank (see Note 4).

In March 2020, the World Health Organization declared a pandemic related to the rapidly spreading coronavirus (“COVID-19”) outbreak.  The Company faces various risks related to health epidemics, pandemics and similar outbreaks, including the global outbreak of COVID-19.  The Company believes it has taken appropriate steps to minimize the risk to our employees and to maintain normal business operations and continues to actively monitor the global outbreak and spread of COVID-19 and continues to take steps to mitigate the potential risks to us posed by its spread and related circumstances and impacts.  Due to the change in consumer buying patterns as a result of COVID-19, the Company has experienced a decline in new client sales resulting in a decrease in revenues in fiscal 2020 compared to fiscal 2019. While the ultimate health and economic impact of COVID-19 remains highly uncertain, we expect that our business operations and results of operations, including our net sales, earnings and cash flows, may continue to be impacted by decreases in new client sales.  We cannot predict the timing and speed of the recovery, and any delay in the recovery could significantly impact our future results.  

Consistent with its fiduciary duties, the board of directors and management has reviewed and will continue to review strategic options and opportunities for the Company, in order to maximize shareholder value.  These options may include, but are not limited to, strategic mergers or acquisitions, investments in other public and/or private companies, repurchases of RSA interests, a deregistration of the Company's common stock under the Securities Exchange Act of 1934 or a going-private transaction.   These options may or may not be related to the Company’s current business.  In order to undertake any of the aforementioned activities, the Company may take on substantial debt or equity capital which could increase the risk of investment in the Company.

Results of Operations

Revenue.  For the fiscal year ended November 30, 2020, the Company had revenue of $31,147,593 compared to $31,816,571 for the fiscal year ended November 30, 2019.  The 2% decrease in revenue was primarily attributable to a 1% decrease in processing and storage fees and a 37% decrease in licensee income.

16


Processing and Storage Fees. For the fiscal year ended November 30, 2020, processing and storage fees were $29,547,150 compared to $29,991,972 for the fiscal year ended November 30, 2019.  Processing and storage fee revenue is attributable to an 8% increase in recurring annual storage fee revenue offset by a 10% decrease in the number of new domestic cord blood specimens processed in fiscal 2020 versus fiscal 2019.  

Product Revenue. For the twelve months ended November 30, 2020, revenue from the product sales was $244,187 compared to $172,395 for the twelve months ended November 30, 2019.  

Public Cord Blood Banking Revenue.  For the twelve months ended November 30, 2020, revenue from the public cord blood banking sales was $726,554 compared to $652,204 for the twelve months ended November 30, 2019.

Licensee Income.  For the fiscal year ended November 30, 2020, licensee income was $629,702 as compared to $1,000,000 for fiscal 2019.  Licensee income for the twelve months ended November 30, 2020 and November 30, 2019 consists of royalty income earned on the processing and storage of cord blood stem cell specimens in India where the Company has a definitive License and Royalty Agreement.  

Per the License and Royalty Agreement with LifeCell, there is a $1,000,000 cap on the amount of royalties due to the Company per year and a $10,000,000 cap on the amount of royalties due to the Company for the term of the License and Royalty Agreement.   The cap(s) are calculated based on LifeCell’s fiscal year end, March 31st.  As of the end of the Company’s fiscal year ended November 30, 2020, the Company had reached the $10,000,000 cap and recorded the remaining $629,702 due.  As of the end of the Company’s fiscal year ended November 30, 2019, LifeCell had reached the $1,000,000 cap.  Since inception of the License and Royalty Agreement, the Company has recorded $10,000,000 in royalty income due under the terms of the License and Royalty Agreement, of which, LifeCell has paid the Company $8,900,000 as of November 30, 2020.  The balance of $1,100,000 is reflected as Accounts Receivable on the accompanying consolidated balance sheets.  

Cost of Sales.  For the fiscal year ended November 30, 2020, cost of sales was $9,657,442, as compared to $10,036,175 for the fiscal year ended November 30, 2019, representing a 4% decrease.  Cost of sales includes wages and supplies associated with process enhancements to the existing production procedures and quality systems in the processing of cord blood specimens at the Company’s facility in Oldsmar, Florida and depreciation expense of $205,893 for the year ended November 30, 2020 compared to $195,073 for the 2019 period. Also, included in Cost of Sales is $156,110 and $249,847 related to the costs associated with production of the PrepaCyte CB processing and storage system for the twelve months ended November 30, 2020 and November 30, 2019, respectively. Also included in Cost of Sales is $1,811,723 and $1,295,864 for the twelve months ended November 30, 2020 and November 30, 2019, respectively, related to the public banking due to the Purchase Agreement with Cord:Use.  The decrease in cost of sales for the twelve months ended November 30, 2020 versus November 30, 2019 is due to the decrease in the number of new domestic cord blood specimens processed during the twelve months ended November 30, 2020 versus November 30, 2019 which is offset by the increase in costs due to the public cord blood bank.

Selling, General and Administrative Expenses.  Selling, general and administrative expenses during the fiscal year ended November 30, 2020 were $14,294,233 as compared to $14,891,462 for the fiscal year ended November 30, 2019 representing a 4% decrease. These expenses are primarily comprised of selling and marketing expenses, salaries and wages for personnel and professional fees.  

Research, Development and Related Engineering Expenses. Research, development and related engineering expenses for the fiscal year ended November 30, 2020, were $23,851 as compared to $30,145 in 2019.

Depreciation and Amortization.  Depreciation and amortization (not included in Cost of Sales) for the fiscal year ended November 30, 2020 was $166,437 compared to $206,238 for fiscal 2019.  

17


Change in the Fair Value of Contingent Consideration.  Change in the fair value of the contingent consideration for the fiscal year ended November 30, 2020 was $1,940,205 compared to $742,918 for fiscal 2019. The contingent consideration is the earnout that Cord:Use is entitled to from the Company’s sale of the public cord blood inventory from and after closing, described above.  The contingent consideration was remeasured to fair value as of November 30, 2020.  The estimated fair value of the contingent earnout was determined using a Monte Carlo analysis examining the frequency and mean value of the resulting earnout payments.  The resulting value captures the risk associated with the form of the payout structure.  The risk-neutral method is applied, resulting in a value that captures the risk associated with the form of the payout structure and the projection risk.  The carrying amount of the liability may fluctuate significantly and actual amounts paid may be materially different from the estimated value of the liability.

Impairment of Public Inventory.  The impairment of public inventory for the twelve months ended November 30, 2020 was $1,284,238 compared to $2,332,763 for the 2019 period.  Due to changes in sales trends and estimated recoverability of cost capitalized into inventory, an impairment charge of $1,284,238 and $2,332,763 was recognized during the twelve months ended November 30, 2020 and November 30, 2019, respectively, to reduce inventory from cost to net realizable value.

Interest Expense.  Interest expense during the fiscal year ended November 30, 2020 was $1,544,017 compared to $1,703,446 in fiscal 2019, of which $395,426 and $759,386, respectively, related to the credit and subordination agreements with Texas Capital Bank, National Association as described in Note 4.  The remaining interest expense is comprised of amounts due to the parties to the Company’s revenue sharing agreements based on the Company’s storage revenue collected.  

Extinguishment of Revenue Sharing Agreement.  On August 31, 2020, the Company entered into a Termination Agreement with the Erie Group pursuant to which all such parties terminated all of their respective rights, duties, obligations, options, and liabilities to each other arising out of or related to the Cryo-Cell International, Inc. Space and Time Sharing (SATS) Lease Agreement, Addendum thereto, Addition to such Addendum, and Amendment to the Cryo-Cell International, Inc. Space and Time Sharing (SATS) Lease Agreement among the Company and the Erie Group (collectively, the “SATS Agreement”). Additionally, pursuant to the terms of the Termination Agreement, the Company made a payment of $1,939,748 on the Effective Date and the parties released each other from all claims related to the SATS Agreement and to dismiss with prejudice the previously disclosed complaint (See Note 12).  Pursuant to the terms of the Agreement, the Erie Group will no longer have the rights to share in a portion of the Company’s storage revenues derived from specimens which originated in the state of Illinois and its five contiguous states. The payment amount of $1,939,748 was offset by the carrying amount of the long-term liability related to the SATS in the amount of $550,000 and accrued expenses in the amount of $279,100 to reflect the extinguishment of revenue sharing agreements in the amount of $1,070,900 for the twelve months ended November 30, 2020.

Income Taxes.  U.S. income tax expense for the twelve months ended November 30, 2020 was $1,346,625, net of foreign taxes, compared to $992,491, net of foreign income taxes, for the twelve months ended November 30, 2019.  

Deferred tax assets and liabilities are measured using enacted tax rates expected to be recovered or settled.  The ultimate realization of our deferred tax assets depends upon generating sufficient future taxable income prior to the expiration of the tax attributes.  In assessing the need for a valuation allowance, we must project future levels of taxable income.  This assessment requires significant judgment.  We examine the evidence related to the recent history of tax losses, the economic conditions in which we operate and our forecasts and projections to make that determination.

The Company records foreign income taxes withheld from installment payments of non-refundable up-front license fees and royalty income earned on the processing and storage of cord blood stem cell specimens in certain geographic areas where the Company has license agreements.  The Company recorded approximately $68,102 and $108,000 for the years ended November 30, 2020 and 2019,

18


respectively, of foreign income tax expense, which is included in income tax expense in the accompanying consolidated statements of comprehensive income.  

There was approximately $1,877,000 and $2,801,000 of U.S. income taxes paid for fiscal years ended November 30, 2020 and November 30, 2019, respectively.

Liquidity and Capital Resources

On May 20, 2016, the Company entered into a Credit Agreement (“Agreement”) with Texas Capital Bank, National Association (“TCB”) for a term loan of $8.0 million in senior credit facilities.  The proceeds of the term loan were used by the Company to fund repurchases of the Company’s common stock.  Subject to the terms of the Agreement, on May 20, 2016, TCB advanced the Company $100.00.  On July 1, 2016, TCB advanced the remaining principal amount of $7,999,900 per a promissory note dated May 20, 2016 between the Company and TCB.

On August 26, 2016, the Company entered into a First Amendment to Credit Agreement with TCB. Pursuant to terms of the First Amendment to Credit Agreement, on August 26, 2016, TCB made an additional advance to the Company in principal amount of $2,133,433 per an Amended and Restated Promissory Note dated August 26, 2016 between the Company and TCB.  The additional proceeds of the term loan were used by the Company to fund the extinguishment of revenue sharing agreements.

On June 11, 2018, the Company entered into a Second Amendment to Credit Agreement with TCB.  Pursuant to the terms of the Second Amendment to Credit Agreement, TCB made an additional advance to the Company in principal amount of $9,000,000 per an Amended and Restated Promissory Note dated June 11, 2018 between the Company and TCB in the principal amount of $15,500,000.  The proceeds were used to finance a portion of the purchase price of the Cord:Use Purchase.  

Prior to the loans, the Company’s principal source of cash has been from sales of its umbilical cord blood program to customers and royalties from licensees.

At November 30, 2020, the Company had cash and cash equivalents of $10,361,125 as compared to $6,541,037 at November 30, 2019.  The increase in cash and cash equivalents during the twelve months ended November 30, 2020 was primarily attributable to the following:

Net cash provided by operating activities in fiscal 2020 was $8,466,603 which was attributable to the Company’s operating activities and a portion of the Company’s new clients choosing the prepaid storage plans versus the annual storage fee plan.    

Net cash provided by operating activities in fiscal 2019 was $6,294,843 which was attributable to the Company’s operating activities and an increase in the Company’s new clients choosing the prepaid storage plans versus the annual storage fee plan.  

Net cash provided by investing activities in fiscal 2020 was $357,485 which was attributable to cash received due to the liquidation of marketable securities in the amount of $807,447, offset by $99,962 used to purchase property and equipment and $350,000 used as part of the Patent Option Agreement with Duke (See Note 19).

Net cash used in investing activities in fiscal 2019 was $662,295 which was primarily attributable to cash used to purchase property and equipment.

Net cash used in financing activities in fiscal 2020 was $5,004,000, which was primarily attributable to the payments of $3,100,000 to repay the note payable described above, $1,900,000 used to terminate a revenue sharing agreement (See Note 14), and $45,000 used to pay the Cord:Use earnout (See Note 1) which are offset by the receipt of $41,000 from the exercise of stock options.

19


Net cash used in financing activities in fiscal 2019 was $5,131,544, which was primarily attributable to the payments of $4,100,000 to repay the note payable described above and $45,000 to Cord:Use and $992,244 used to repurchase common stock which was offset by the receipt of $5,700 from the exercise of stock options.

The Company does not have a line of credit.  

The Company anticipates making discretionary capital expenditures of approximately $500,000 over the next twelve months for software enhancements and purchases of property and equipment.  The Company anticipates funding future property and equipment purchases with cash-on-hand and cash flows from future operations.

The Company anticipates that its cash and cash equivalents, marketable securities and cash flows from future operations will be sufficient to fund its known cash needs for at least the next 12 months. Cash flows from operations will depend primarily upon increasing revenues from sales of its umbilical cord blood and cord tissue cellular storage services and managing discretionary expenses.  If expected increases in revenues are not realized, or if expenses are higher than anticipated, the Company may be required to reduce or defer cash expenditures or otherwise manage its cash resources during the next 12 months so that they are sufficient to meet the Company’s cash needs for that period.  In addition, the Company may consider seeking equity or debt financing if deemed appropriate for its plan of operations, and if such financing can be obtained on acceptable terms.  There is no assurance that any reductions in expenditures, if necessary, will not have an adverse effect on the Company’s business operations, including sales activities and the development of new services and technology.

Critical Accounting Policies and Estimates

The preparation of consolidated financial statements and related disclosures in conformity with accounting principles generally accepted in the United States requires estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and expenses and related disclosures of contingent assets and liabilities in the consolidated financial statements and accompanying notes.  The SEC has defined a company’s critical accounting policies as the ones that are most important to the portrayal of the company’s financial condition and results of operations, and which require the company to make its most difficult and subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain.  The Company believes that its estimates and assumptions are reasonable under the circumstances; however, actual results may vary from these estimates and assumptions.  We have identified the following critical accounting policies that affect the more significant judgments and estimates used in the preparation of the consolidated financial statements.  For further discussion of the Company’s significant and critical accounting policies, refer to Note 1 – “Description of Business and Summary of Critical and Significant Accounting Policies” to the Consolidated Financial Statements contained in Item 8 of this document.

Revenue Recognition

Effective December 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), using the modified retrospective transition method. The Company recognized the cumulative effect of applying the new revenue standard to all contracts with customers that were not completed as of December 1, 2018 as an adjustment to the opening balance of stockholders' deficit at the beginning of fiscal year 2019. The reported results for 2019 reflect the application of ASC 606 guidance while the reported results for 2018 were prepared under the guidance of ASC 605, Revenue Recognition (ASC 605).  ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. ASC 606 also impacts certain other areas, such as the accounting for costs to obtain or fulfill a contract. ASC 606 also requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers.

20


The adoption of ASC 606 did not have an impact on the amount of reported revenues with respect to the Company’s product or service revenues. In connection with the adoption of ASC 606, the Company is required to capitalize certain contract acquisition costs consisting primarily of commissions paid when contracts are signed and amortize these costs on a systematic basis, consistent with the pattern of transfer of the storage services provided over time for which the asset relates. As of December 1, 2018, the Company capitalized in deposits and other assets, net, $329,231 in incremental contract acquisition costs related to sales commissions on prepaid storage contracts and reversed $18,408 of its variable consideration that the Company determined to be fully constrained, with a corresponding change in the opening balance of stockholders’ deficit of $253,447, net of tax, of $94,192.

Under ASC 606, revenue is recognized when, or as, obligations under the terms of a contract are satisfied, which occurs when control of the promised services are transferred to the customers. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring services to a customer ("transaction price").

At contract inception, if the contract is determined to be within the scope of ASC 606, the Company evaluates its contracts with customers using the five-step model: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to separate performance obligations; and (5) recognize revenue when (or as) each performance obligation is satisfied. The Company evaluates its contracts for legal enforceability at contract inception and subsequently throughout the Company’s relationship with its customers. If legal enforceability with regards to the rights and obligations exist for both the Company and the customer, then the Company has an enforceable contract and revenue recognition is permitted subject to the satisfaction of the other criteria. If, at the outset of an arrangement, the Company determines that a contract with enforceable rights and obligations does not exist, revenues are deferred until all criteria for an enforceable contract are met.  The Company only applies the five-step model to contracts when it is probable that collection of the consideration that the Company is entitled to in exchange for the goods or services being transferred to the customer, will occur.  

Income Taxes

Deferred income tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred income tax assets and liabilities are measured using enacted tax rates expected to be recovered or settled.  The Company records a valuation allowance when it is “more likely than not” that all future income tax benefits will be realized.  When the Company changes its determination as to the amount of deferred income tax assets that can be realized, the valuation allowance is adjusted with a corresponding impact to income tax expense in the period in which such determination is made.  The ultimate realization of the Company’s deferred income tax assets depends upon generating sufficient taxable income prior to the expiration of the tax attributes.  In assessing the need for a valuation allowance, the Company projects future levels of taxable income.  This assessment requires significant judgment.  The Company examines the evidence related to the recent history of losses, the economic conditions in which the Company operates and forecasts and projections to make that determination.

Long-Lived Assets

The Company evaluates the realizability of its long-lived assets, which requires impairment losses to be recorded on long-lived assets used in operations when indicators of impairment, such as reductions in demand or when significant economic slowdowns are present.  Reviews are performed to determine whether the carrying value of an asset is impaired, based on comparisons to undiscounted expected future cash flows.  If this comparison indicates that there is impairment and carrying value is in excess of fair value, the impaired asset is written down to fair value, which is typically calculated using: (i) quoted market prices or (ii) discounted expected future cash flows utilizing a discount rate.  The Company did not note any impairment for the twelve months ended November 30, 2020 and 2019.

21


Goodwill

Goodwill represents the excess of the purchase price of the assets acquired from Cord:Use over the estimated fair value of the net tangible and identifiable assets acquired.  The annual assessment of the reporting unit is performed as of September 1st, and an assessment is performed at other times if an event occurs or circumstances change that would more likely than not reduce the fair value of the asset below its carrying value.  The Company first performs a qualitative assessment to test goodwill for impairment and concludes if it is more likely than not that the fair value of the reporting unit is less than its carrying value.  If the qualitative assessment concludes that it is not more likely than not that the fair value is less than the carrying value, the two-step goodwill impairment test is not required.  If the qualitative assessment concludes that it is more likely than not that the fair value of the reporting unit is less than the carrying value, then the two-step goodwill impairment test is required.  Step one of the impairment assessment compares the fair value of the reporting unit to its carrying value and if the fair value exceeds its carrying value, goodwill is not impaired. If the carrying value exceeds the fair value, the implied fair value of goodwill is compared to the carrying value of goodwill. If the implied fair value exceeds the carrying value then goodwill is not impaired; otherwise, an impairment loss would be recorded by the amount the carrying value exceeds the implied fair value.  

Stock Compensation

As of November 30, 2020, the Company has two stock-based employee compensation plans, which are described in Note 10 to the consolidated financial statements.  

The Company recognizes stock-based compensation based on the fair value of the related awards. Under the fair value recognition guidance of stock-based compensation accounting rules, stock-based compensation expense is estimated at the grant date based on the fair value of the award and is recognized as expense over the requisite service period of the award.  The fair value of service-based vesting condition and performance-based vesting condition stock option awards is determined using the Black-Scholes valuation model.  For stock option awards with only service-based vesting conditions and graded vesting features, the Company recognizes stock compensation expense based on the graded-vesting method.  To value awards with market-based vesting conditions the Company uses a binomial valuation model. The Company recognizes compensation cost for awards with market-based vesting conditions on a graded-vesting basis over the derived service period calculated by the binomial valuation model.  The use of these valuation models involves assumptions that are judgmental and highly sensitive in the determination of compensation expense and include the expected life of the option, stock price volatility, risk-free interest rate, dividend yield, exercise price, and forfeiture rate. Forfeitures are estimated at the time of valuation and reduce expense ratably over the vesting period.

The estimation of stock awards that will ultimately vest requires judgment and to the extent that actual results or updated estimates differ from current estimates, such amounts will be recorded as a cumulative adjustment in the period they become known.  The Company considered many factors when estimating forfeitures, including the recipient groups and historical experience.  Actual results and future changes in estimates may differ substantially from current estimates.

The Company issues performance-based equity awards which vest upon the achievement of certain financial performance goals, including revenue and income targets.  Determining the appropriate amount to expense based on the anticipated achievement of the stated goals requires judgment, including forecasting future financial results.  The estimate of the timing of the expense recognition is revised periodically based on the probability of achieving the required performance targets and adjustments are made as appropriate.  The cumulative impact of any revision is reflected in the period of the change.  If the financial performance goals are not met, the award does not vest, so no compensation cost is recognized and any previously stock-recognized stock-based compensation expense is reversed.

22


The Company issues equity awards with market-based vesting conditions which vest upon the achievement of certain stock price targets.  If the awards are forfeited prior to the completion of the derived service period, any recognized compensation is reversed.  If the awards are forfeited after the completion of the derived service period, the compensation cost is not reversed, even if the awards never vest.

License and Royalty Agreements

The Company has entered into licensing agreements with certain investors in various international markets in an attempt to capitalize on the Company’s technology.   The investors typically pay a licensing fee to receive Company marketing programs, technology and know-how in a selected area.  The investor may be given a right to sell sub-license agreements as well.  As part of the accounting for the up-front license revenue, revenue from the up-front license fee is recognized based on such factors as when the payment is due, collectability and when all material services or conditions relating to the sale have been substantially performed based on the terms of the agreement.  The Company has twelve active licensing agreements.  The following areas each have one license agreement: El Salvador, Guatemala, Panama, Honduras, China, and Pakistan.  The following areas each have two license agreements: India, Nicaragua and Costa Rica.  In October 2012, the Company sent a notice of termination to the Company’s Venezuelan affiliate for failure to meet its payment obligation in accordance with the contract.  Subsequent to the notice of termination, payment was received for outstanding processing and storage fees due from Venezuela.  The Company is in the process of discussing a new agreement with Venezuela.  In December 2012, the Company sent notice of termination to the Company’s affiliate in Ecuador for failure to meet its payment obligation in accordance with the contract.  Subsequent to the notice of termination, payment was received for outstanding processing and storage fees due from Ecuador.  In August 2013, the Company was notified that its affiliate in Ecuador was closed by the National Institute of Organic Donation (INDOT).  As a result, the Company recorded an allowance for uncollectible receivables for the $150,000 processing and storage fee receivable due from Ecuador in the third quarter of fiscal 2013.  During the fourth quarter of fiscal 2013, the Company began to bill the Ecuadorian clients directly for cord blood specimens that are stored at the Company’s facility in Oldsmar, Florida.  In the future, if the Company loses revenue due to lack of payment from the foreign affiliates or the foreign affiliates are closed, the Company’s overall revenue will decrease.

In addition to the license fee, the Company earns a royalty on processing and storage fees on subsequent processing and storage revenues received by the licensee in the licensed territory and a fee on any sub-license agreements that are sold by the licensee where applicable.  The Company processes and stores specimens sent directly from customers of licensees in Mexico, El Salvador, Guatemala, Ecuador, Panama, Honduras, Nicaragua, Costa Rica, Pakistan and Venezuela.  The Company also processes and stores specimens from sub-licenses of Venezuela, who are Chile, Colombia and Peru.  These fees are included in processing and storage fees revenue on the consolidated statements of comprehensive income.  As part of the accounting for royalty revenue from India, the Company uses estimates and judgments based on historical processing and storage volume in determining the timing and amount of royalty revenue to recognize.  The Company periodically reviews license and royalty receivables for collectability and, if necessary, will record an expense for an allowance for uncollectible accounts.  If the financial condition of the Company’s sub-licensees were to deteriorate beyond the estimates, the Company may have to increase the allowance for doubtful accounts which could have a negative impact on earnings.  If the licensee’s customer base were to decrease, it would negatively impact the Company’s ongoing license income.

Accounts Receivable

Accounts receivable consist of uncollateralized amounts due from clients that have enrolled and processed in the umbilical cord blood stem cell processing and storage programs and amounts due from license affiliates, and sublicensee territories.  Accounts receivable are due within 30 days and are stated at amounts net of an allowance for doubtful accounts.  Accounts outstanding longer than the contractual payment terms are considered past due.  The Company determines its allowance by considering the length of time accounts receivable are past due, the Company’s previous loss history, and the client’s current

23


ability to pay its obligations.  Therefore, if the financial condition of the Company’s clients were to deteriorate beyond the estimates, the Company may have to increase the allowance for doubtful accounts which could have a negative impact on earnings.  The Company writes-off accounts receivable when they become uncollectible, and payments subsequently received on such receivables are credited to the allowance for doubtful accounts.  

Inventories

As part of the Asset Purchase Agreement, the Company has an agreement with Duke University (“Duke”) expiring on January 31, 2025 for Duke to receive, process, and store cord blood units for the Public Cord Blood Bank (“Duke Services”). As of November 30, 2020, the Company had approximately 6,000 cord blood units in inventory. These units are valued at the lower of cost or net realizable value. Costs include the cost of collecting, transporting, processing and storing the unit. Costs charged by Duke for their Duke Services are based on a monthly fixed fee for processing and storing 12 blood units per month. The Company computes the cost per unit for these Duke Services and capitalizes the unit cost on all blood units shipped and stored in a year at Duke. If the Company ships and stores less than 144 blood units with Duke in a one-year period, a portion of these fixed costs are expensed and included in facility operating costs. Certain costs of collection incurred, such as the cost of collection staff and transportation costs incurred to ship Public Bank units from hospitals to the stem cell laboratory are allocated to banked units based on an average cost method. The change in the number of expected units to be sold could have a significant impact on the estimated net realizable value of banked units which could have a material effect on the value of the inventory.  Costs incurred related to cord blood units that cannot be sold are expensed in the period incurred and are included in facility operating costs in the accompanying statements of operations. The Company records a reserve against inventory for units which have been processed and frozen but may not ultimately become distributable (see Note 2).

Patents and Trademarks

The Company incurs certain legal and related costs in connection with patent and trademark applications. If a future economic benefit is anticipated from the resulting patent or trademark or an alternate future use is available to the Company, such costs are capitalized and amortized over the expected life of the patent or trademark.  The Company’s assessment of future economic benefit involves considerable management judgment. A different conclusion could result in the reduction of the carrying value of these assets.

Revenue Sharing Agreements

The Company has entered into Revenue Sharing Agreements (“RSAs”) with various parties whereby these parties contracted with the Company for a percentage of future storage revenues the Company generates and collects from clients in specific geographical areas.  The RSAs have no definitive term or termination provisions.  The sharing applies to the storage fees collected for all specified specimens in the area up to the number covered in the contract.  When the number of specimens is filled, any additional specimens stored in that area are not subject to revenue sharing.  As there are empty spaces resulting from attrition, the Company agrees to fill them as soon as possible.  The parties typically pay the Company a non-refundable up-front fee for the rights to these future payments.  The Company recognized these non-refundable fees as a long-term liability.  Given the criteria under which these RSAs are established, cash flows related to these contracts can fluctuate from period to period.  All payments made to the other parties to the RSAs are recognized as interest expense.  At such time as the total payments can be determined, the Company will commence amortizing these liabilities under the effective interest method.  The Company does not intend to enter into additional RSAs.

24


Contingent Consideration

The contingent consideration is the earnout that Cord:Use is entitled to from the Company’s  sale of the public cord blood inventory from and after closing.  The estimated fair value of the contingent earnout was determined using a Monte Carlo analysis examining the frequency and mean value of the resulting earnout payments.  The resulting value captures the risk associated with the form of the payout structure.  The risk-neutral method is applied, resulting in a value that captures the risk associated with the form of the payout structure and the projection risk.  The carrying amount of the liability may fluctuate significantly and actual amounts paid may be materially different from the estimated value of the liability.

Recently Issued Accounting Pronouncements

See Note 1 to the Consolidated Financial Statements.

Off-Balance Sheet Arrangements

The Company has no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on its financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

25


ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

Not applicable, as the Company is a smaller reporting company.

26


ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.

The consolidated financial statements and supplementary data listed in the accompanying Index to Consolidated Financial Statements are attached as part of this report.

 

The following consolidated financial statements of Cryo-Cell International, Inc. are included in Item 8:

 

Report of Independent Registered Public Accounting Firm

28

 

 

Consolidated Balance Sheets as of November 30, 2020 and 2019

29

 

 

Consolidated Statements of Comprehensive Income For the Fiscal Years Ended November 30, 2020 and 2019

30

 

 

Consolidated Statements of Cash Flows For the Fiscal Years Ended November 30, 2020 and 2019

31

 

 

Consolidated Statements of Stockholders’ Deficit For the Fiscal Years Ended November 30, 2020 and 2019

32

 

 

Notes to Consolidated Financial Statements

33

 

All other schedules for which provision is made in the applicable accounting regulations of the Securities and Exchange Commission are not required under the related instructions, are already included in the Notes to Consolidated Financial Statements included under this Item 8 or are inapplicable, and therefore have been omitted.

 

27


 

 

 

235 Peachtree Street NE

404 588 4200

Suite 1800

wipfli.com

Atlanta, GA 30303

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders

Cryo-Cell International, Inc.

Oldsmar, Florida

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Cryo-Cell International, Inc. and subsidiaries (the “Company”), as of November 30, 2020 and 2019, and the related consolidated statements of comprehensive income, changes in stockholders’ deficit, and cash flows for the years then ended and the related notes to the consolidated financial statements (collectively, the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of November 30, 2020 and 2019, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ Wipfli LLP

We have served as the Company’s auditor since 2016.

Atlanta, Georgia

March 1, 2021

28


CRYO-CELL INTERNATIONAL, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

 

 

November 30,

 

 

November 30,

 

 

 

2020

 

 

2019

 

ASSETS

 

 

 

 

 

 

 

 

Current Assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

10,361,125

 

 

$

6,541,037

 

Marketable securities

 

 

88,476

 

 

 

904,053

 

Accounts receivable (net of allowance for

 

 

 

 

 

 

 

 

doubtful accounts of $2,781,668 and $2,584,091, respectively)

 

 

6,322,960

 

 

 

6,097,331

 

Prepaid expenses

 

 

611,627

 

 

 

500,260

 

Inventory, current portion

 

 

927,318

 

 

 

1,084,533

 

Other current assets

 

 

244,696

 

 

 

260,397

 

Total current assets

 

 

18,556,202

 

 

 

15,387,611

 

Property and Equipment-net

 

 

1,640,774

 

 

 

1,846,467

 

Other Assets

 

 

 

 

 

 

 

 

Investment - Tianhe stock

 

 

308,000

 

 

 

308,000

 

Patent option agreement

 

 

350,000

 

 

 

 

Intangible assets, net

 

 

1,181,588

 

 

 

1,249,254

 

Inventory, net of current portion

 

 

11,064,034

 

 

 

12,646,000

 

Goodwill

 

 

1,941,411

 

 

 

1,941,411

 

Deferred tax assets

 

 

10,363,967

 

 

 

9,079,994

 

Operating lease right-of-use asset

 

 

299,089

 

 

 

 

Deposits and other assets, net

 

 

495,029

 

 

 

427,423

 

Total other assets

 

 

26,003,118

 

 

 

25,652,082

 

Total assets

 

$

46,200,094

 

 

$

42,886,160

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

957,390

 

 

$

1,369,111

 

Accrued expenses

 

 

2,898,211

 

 

 

2,085,180

 

Current portion of note payable

 

 

3,100,000

 

 

 

3,100,000

 

Current portion of operating lease liability

 

 

275,570

 

 

 

 

Deferred revenue

 

 

9,183,450

 

 

 

8,875,138

 

Total current liabilities

 

 

16,414,621

 

 

 

15,429,429

 

Other Liabilities

 

 

 

 

 

 

 

 

Deferred revenue, net of current portion

 

 

27,200,910

 

 

 

23,633,373

 

Contingent consideration

 

 

1,509,852

 

 

 

3,495,057

 

Note payable, net of current portion and debt issuance costs

 

 

2,841,214

 

 

 

5,856,152

 

Operating lease long-term liability

 

 

23,632

 

 

 

 

Long-term liability - revenue sharing agreements

 

 

875,000

 

 

 

1,425,000

 

Total other liabilities

 

 

32,450,608

 

 

 

34,409,582

 

Total liabilities

 

 

48,865,229

 

 

 

49,839,011

 

Commitments and contingencies (Note 12)

 

 

 

 

 

 

Stockholders' Deficit

 

 

 

 

 

 

 

 

Preferred stock ($.01 par value, 500,000 authorized and none issued and

   outstanding)

 

 

 

 

 

 

Series A Junior participating preferred stock ($.01 par value, 20,000

   authorized and none issued and outstanding)

 

 

 

 

 

 

Common stock ($.01 par value, 20,000,000 authorized; 13,633,638 issued

   and 7,545,613 outstanding as of November 30, 2020 and 13,598,909

   issued and 7,510,884 outstanding as of November 30, 2019)

 

 

136,336

 

 

 

135,989

 

Additional paid-in capital

 

 

36,581,600

 

 

 

35,918,827

 

Treasury stock, at cost

 

 

(20,563,357

)

 

 

(20,563,357

)

Accumulated deficit

 

 

(18,819,714

)

 

 

(22,444,310

)

Total stockholders' deficit

 

 

(2,665,135

)

 

 

(6,952,851

)

Total liabilities and stockholders' deficit

 

$

46,200,094

 

 

$

42,886,160

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

29


CRYO-CELL INTERNATIONAL, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

 

 

 

November 30,

 

 

November 30,

 

 

 

2020

 

 

2019

 

Revenue:

 

 

 

 

 

 

 

 

Processing and storage fees

 

$

29,547,150

 

 

$

29,991,972

 

Public banking revenue

 

 

726,554

 

 

 

652,204

 

Licensee and royalty income

 

 

629,702

 

 

 

1,000,000

 

Product revenue

 

 

244,187

 

 

 

172,395

 

Total revenue

 

 

31,147,593

 

 

 

31,816,571

 

Costs and Expenses:

 

 

 

 

 

 

 

 

Cost of sales

 

 

9,657,442

 

 

 

10,036,175

 

Selling, general and administrative expenses

 

 

14,294,233

 

 

 

14,891,462

 

Impairment of public inventory

 

 

1,284,238

 

 

 

2,332,763

 

Change in fair value of contingent consideration

 

 

(1,940,205

)

 

 

(742,918

)

Research, development and related engineering

 

 

23,851

 

 

 

30,145

 

Depreciation and amortization

 

 

166,437

 

 

 

206,238

 

Total costs and expenses

 

 

23,485,996

 

 

 

26,753,865

 

Operating Income

 

 

7,661,597

 

 

 

5,062,706

 

Other Expense:

 

 

 

 

 

 

 

 

(Losses) gains on marketable securities

 

 

(8,130

)

 

 

28,364

 

Other income

 

 

773

 

 

 

3,791

 

Interest expense

 

 

(1,544,017

)

 

 

(1,703,446

)

Loss on extinguishment of revenue sharing agreement

 

 

(1,070,900

)

 

 

 

Total other expense

 

 

(2,622,274

)

 

 

(1,671,291

)

Income before income tax expense

 

 

5,039,323

 

 

 

3,391,415

 

Income tax expense

 

 

(1,414,727

)

 

 

(1,100,641

)

Net Income and Comprehensive Income

 

$

3,624,596

 

 

$

2,290,774

 

Net income per common share - basic

 

$

0.48

 

 

$

0.29

 

Weighted average common shares outstanding - basic

 

 

7,544,494

 

 

 

7,794,828

 

Net income per common share - diluted

 

$

0.45

 

 

$

0.27

 

Weighted average common shares outstanding - diluted

 

 

8,140,180

 

 

 

8,412,414

 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

30


CRYO-CELL INTERNATIONAL, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

 

 

November 30,

 

 

November 30,

 

 

 

2020

 

 

2019

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net income

 

$

3,624,596

 

 

$

2,290,774

 

Adjustments to reconcile net income to net cash provided by

   operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization expense

 

 

372,289

 

 

 

401,311

 

Impairment of public inventory

 

 

1,284,238

 

 

 

2,332,763

 

Loss on disposal of property and equipment

 

 

1,032

 

 

 

 

Change in fair value of contingent consideration

 

 

(1,940,205

)

 

 

(742,918

)

Losses (gains) on marketable securities

 

 

8,130

 

 

 

(28,364

)

Compensatory element of stock options

 

 

622,120

 

 

 

397,770

 

Provision for doubtful accounts

 

 

602,965

 

 

 

767,128

 

Loss on extinguishment of revenue sharing agreements

 

 

1,070,900

 

 

 

 

Deferred income tax expense

 

 

(1,283,973

)

 

 

(1,517,289

)

Amortization of debt issuance costs

 

 

85,062

 

 

 

112,642

 

Amortization of operating lease right-of-use asset

 

 

263,686

 

 

 

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(828,594

)

 

 

(997,124

)

Prepaid expenses

 

 

(111,367

)

 

 

(38,445

)

Inventory

 

 

454,943

 

 

 

(27,423

)

Other current assets

 

 

15,701

 

 

 

(5,932

)

Deposits and other assets, net

 

 

(67,606

)

 

 

15,696

 

Accounts payable

 

 

(411,721

)

 

 

107,458

 

Accrued expenses

 

 

1,092,131

 

 

 

(599,200

)

Operating lease liability

 

 

(263,573

)

 

 

 

Deferred revenue

 

 

3,875,849

 

 

 

3,825,996

 

Net cash provided by operating activities

 

 

8,466,603

 

 

 

6,294,843

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(99,962

)

 

 

(662,295

)

Purchase of patent option agreement

 

 

(350,000

)

 

 

 

Liquidation of marketable securities

 

 

807,447

 

 

 

 

Net cash provided by (used in) investing activities

 

 

357,485

 

 

 

(662,295

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Extinguishment of revenue sharing agreements

 

 

(1,900,000

)

 

 

 

Treasury stock purchases

 

 

 

 

 

(992,244

)

Repayments of note payable

 

 

(3,100,000

)

 

 

(4,100,000

)

Proceeds from the exercise of stock options

 

 

41,000

 

 

 

5,700

 

Payment of Cord:Use earnout

 

 

(45,000

)

 

 

(45,000

)

Net cash used in financing activities

 

 

(5,004,000

)

 

 

(5,131,544

)

Increase in cash and cash equivalents

 

 

3,820,088

 

 

 

501,004

 

Cash and cash equivalents - beginning of period

 

 

6,541,037

 

 

 

6,040,033

 

Cash and cash equivalents - end of period

 

$

10,361,125

 

 

$

6,541,037

 

Supplemental non-cash operating activities:

 

 

 

 

 

 

 

 

Operating lease right-of-use asset recorded due to adoption of ASC

   842

 

$

562,775

 

 

$

 

Operating lease liability recorded due to adoption of ASC 842

 

$

562,775

 

 

$

 

Cumulative-effect adjustment due to the adoption of ASU 2016-01

 

$

 

 

$

(340,984

)

 

The accompanying notes are an integral part of these consolidated financial statements.

31


CRYO-CELL INTERNATIONAL, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-In

 

 

Treasury

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Stock

 

 

Income

 

 

Deficit

 

 

Deficit

 

Balance at November 30, 2018

 

 

13,596,409

 

 

$

135,964

 

 

$

35,515,382

 

 

$

(19,571,113

)

 

$

340,984

 

 

$

(25,329,515

)

 

$

(8,908,298

)

Common stock issued

 

 

2,500

 

 

$

25

 

 

$

5,675

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

5,700

 

Compensatory element of stock

   options

 

 

 

 

 

 

 

 

 

 

397,770

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

397,770

 

Cumulative-effect adjustment due to

   the adoption of ASU 2016-01

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(340,984

)

 

 

340,984

 

 

 

 

ASC 606 adoption adjustment, net of

   tax ($94,192)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

253,447

 

 

 

253,447

 

Treasury Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(992,244

)

 

 

 

 

 

 

 

 

 

 

(992,244

)

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,290,774

 

 

 

2,290,774

 

Balance at November 30, 2019

 

 

13,598,909

 

 

$

135,989

 

 

$

35,918,827

 

 

$

(20,563,357

)

 

$

 

 

$

(22,444,310

)

 

$

(6,952,851

)

Common stock issued

 

 

34,729

 

 

 

347

 

 

 

40,653

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41,000

 

Compensatory element of stock

   options

 

 

 

 

 

 

 

 

 

 

622,120

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

622,120

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,624,596

 

 

 

3,624,596

 

Balance at November 30, 2020

 

 

13,633,638

 

 

$

136,336

 

 

$

36,581,600

 

 

$

(20,563,357

)

 

$

 

 

$

(18,819,714

)

 

$

(2,665,135

)

 

The accompanying notes are an integral part of these consolidated financial statements.

32


CRYO-CELL INTERNATIONAL, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

NOVEMBER 30, 2020 and 2019

 

NOTE 1 – DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Description of Business.

Cryo-Cell International, Inc. (“the Company” or “Cryo-Cell”) was incorporated in Delaware on September 11, 1989 and is headquartered in Oldsmar, Florida.  The Company is organized in three reportable segments, cellular processing and cryogenic cellular storage, with a current focus on the collection and preservation of umbilical cord blood stem cells for family use, the manufacture of PrepaCyte CB units, the processing technology used to process umbilical cord blood stem cells and cellular processing and cryogenic storage of umbilical cord blood stem cells for public use.  Revenues for the cellular processing and cryogenic cellular storage represent sales of the umbilical cord blood stem cells program to customers and income from licensees selling the umbilical cord blood stem cells program to customers outside the United States.  Revenues for the manufacture of PrepaCyte CB units represent sales of the PrepaCyte CB units to customers.  Revenue for the cryogenic storage of umbilical cord blood stem cells for public use, stored at Duke University (see below), is generated from the sale of the cord blood units to the National Marrow Donor Program (“NMDP”), which distributes the cord blood units to transplant centers located in the United States and around the world.  The Company’s headquarters facility in Oldsmar, Florida handles all aspects of its U.S.-based business operations including the processing and storage of specimens, including specimens obtained from certain of its licensees’ customers.  The specimens are stored in commercially available cryogenic storage equipment.

On October 10, 2001, Saneron Therapeutics, Inc. merged into one of the Company’s wholly owned subsidiaries, CCEL Bio-Therapies, Inc. (”CCBT”), which then changed its name to Saneron CCEL Therapeutics, Inc. (“SCTI” or ”Saneron”).  As part of the merger, the Company contributed 260,000 shares of its common stock, whose fair value was $1,924,000 and 195,000 common shares of another of its subsidiaries, Stem Cell Preservation Technologies, Inc., whose fair value was $3,900.  At the conclusion of the merger, the Company retained a 43.42% non-controlling interest in the voting stock of SCTI.  As of November 30, 2020 and 2019, the Company had an interest of approximately 33% in the voting stock of SCTI.  The accompanying consolidated financial statements as of November 30, 2020 and 2019 reflect the investment in SCTI under the equity method of accounting.

Basis of Presentation

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America.

The accompanying consolidated financial statements as of November 30, 2020 and November 30, 2019 and for the years then ended includes the accounts of the Company and all of its subsidiaries, which are inactive.  All intercompany balances have been eliminated upon consolidation.

Concentration of Risks

Financial instruments that potentially subject the Company to concentrations of credit risk are principally cash and cash equivalent accounts in financial institutions, which often exceed the Federal Deposit Insurance Corporation (FDIC) limit.  The Company places its cash with high quality financial institutions and believes it is not exposed to any significant credit risk.  The Company may from time to time invest some of its cash funds in certificates of deposit and bond investments maintained by brokers who are insured under the Securities Investor Protection Corporation (SIPC).  The Company believes these are conservative investments with a low risk for any loss of principal.  The Company regularly assesses its

33


marketable security investments for impairment and adjusts its investment strategy as it deems appropriate.

The Company depends on one supplier for the source of its collection kits, a critical component of the umbilical cord blood stem cell collection process.  However, the Company believes that alternative sources of supply are available.

The Company depends on three suppliers for the supply and manufacturing of the PrepaCyte CB units.  However, the Company believes that alternative sources of supply and manufacturing are available.

The Company depends on one third party, the National Marrow Donor Program, to manage the public umbilical cord stem cells that are needed for transplant.

During fiscal 2020 and 2019, there were no concentration of risks.

Use of Estimates

The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.

Revenue Recognition

Effective December 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), using the modified retrospective transition method.  ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. ASC 606 also impacts certain other areas, such as the accounting for costs to obtain or fulfill a contract. ASC 606 also requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers.

Under ASC 606, revenue is recognized when, or as, obligations under the terms of a contract are satisfied, which occurs when control of the promised services are transferred to the customers. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring services to a customer ("transaction price").

At contract inception, if the contract is determined to be within the scope of ASC 606, the Company evaluates its contracts with customers using the five-step model: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to separate performance obligations; and (5) recognize revenue when (or as) each performance obligation is satisfied. The Company evaluates its contracts for legal enforceability at contract inception and subsequently throughout the Company’s relationship with its customers. If legal enforceability with regards to the rights and obligations exist for both the Company and the customer, then the Company has an enforceable contract and revenue recognition is permitted subject to the satisfaction of the other criteria. If, at the outset of an arrangement, the Company determines that a contract with enforceable rights and obligations does not exist, revenues are deferred until all criteria for an enforceable contract are met.  The Company only applies the five-step model to contracts when it is probable that collection of the consideration that the Company is entitled to in exchange for the goods or services being transferred to the customer, will occur.  

Contract modifications exist when the modification either creates new or changes in the existing enforceable rights and obligations. The Company’s contracts are occasionally modified to account for changes in contract terms and conditions, which the Company refers to as an upgrade or downgrade. An

34


upgrade occurs when a customer wants to pay for additional years of storage. A downgrade occurs when a customer originally entered into a long-term contract (such as twenty-one year or lifetime plan) but would like to change the term to a one-year contract.  Upgrade modifications qualify for treatment as a separate contract as the additional services are distinct and the increase in contract price reflects the Company’s stand-alone selling price for the additional services and will be accounted for on a prospective basis.  Downgrade modifications do not qualify for treatment as a separate contract as there is no increase in price over the original contract, thus failing the separate contract criteria. As such, the Company separately considers downgrade modifications to determine if these should be accounted for as a termination of the existing contract and creation of a new contract (prospective method) or as part of the existing contract (cumulative catch-up adjustment). ASC 606 requires that an entity account for the contract modification as if it were a termination of the existing contract, and the creation of a new contract, if the remaining goods or services are distinct from the goods or services transferred on or before the date of the contract modification.  As the services after the modification were previously determined to be distinct, the Company concluded that downgrade modifications qualify under this method and will be accounted for on a prospective basis.  Although contract modifications do occur, they are infrequent.

Performance Obligations

At contract inception, the Company assesses the goods and services promised in the contracts with customers and identifies a performance obligation for each promise to transfer to the customer a good or service (or bundle of goods or services) that is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. To identify the performance obligations, the Company considers all of the goods or services promised in the contract regardless of whether they are explicitly stated or are implied by customary business practices. The Company determined that the following distinct goods and services represent separate performance obligations involving the sale of its umbilical cord blood product:

 

Collection and processing services

 

Storage services