CRYO CELL INTERNATIONAL INC
For the period ended May 31, 2024. Filed Jul 15, 2024.
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May 31, 2024 · Filed Jul 15, 2024
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Notes to Consolidated Financial Statements
May 31, 2024
Note 1 - Description of Business, Basis of Presentation and Significant Accounting Policies
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 inthree reportable segments: (1) cellular processing and cryogenic cellular storage, with a current focus on the collection and preservation of umbilical cord blood stem cells for family use (2) the manufacture of PrepaCyte CB units, the processing technology used to process umbilical cord blood stem cells and (3) 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.
The unaudited consolidated financial statements including the Consolidated Balance Sheets as of May 31, 2024 and November 30, 2023, the related Consolidated Statements of Income for the three and six months ended May 31, 2024 and 2023, Cash Flows for the three and six months ended May 31, 2024 and 2023 and Stockholders’ Deficit for the three and six months ended May 31, 2024 and 2023 have been prepared by Cryo-Cell International, Inc. pursuant to the rules and regulations of the Securities and Exchange Commission for interim financial reporting. Certain financial information and note disclosures, which are normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America, have been condensed or omitted pursuant to those rules and regulations. It is suggested that these consolidated financial statements be read in conjunction with the financial statements and notes thereto included in the Company's November 30, 2023 Annual Report on Form 10-K. In the opinion of management, all adjustments (which include only normal recurring adjustments) necessary to present fairly the financial position, results of operations, and changes in cash flows for all periods presented have been made. The results of operations for the three and six months ended May 31, 2024 are not necessarily indicative of the results expected for any interim period in the future or the entire year ending November 30, 2024.
On February 22, 2024, the Company formed its wholly owned Delaware subsidiary, Celle Corp. As of May 31, 2024, no shares had been issued to the subsidiary. Celle Corp. was created to hold certain assets of Cryo-Cell not directly associated with the recurring revenue stream from privately banked, umbilical cord blood specimens. The Patent and Technology License Agreement with Duke University and Amendments have been transferred to Celle Corp. and other assets and liabilities are expected to be transferred in the near future.
Revenue Recognition
The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). 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 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
Public cord blood banking
License and royalties
Sale of PrepaCyte CB product
a)
Collection, Processing and Storage Fees
Processing and storage fees include the Company providing umbilical cord blood and tissue cellular processing and cryogenic cellular storage for private use. Revenues recognized for the cellular processing and cryogenic cellular storage represent sales of the umbilical cord blood stem cells program to customers and income from licensees who are selling the umbilical cord blood stem cells program to customers outside the United States.
The Company recognizes revenue from processing fees at the point in time of the successful completion of processing and recognizes storage fees over time, which isratably over the contractual storage period as well as other income from royalties paid by licensees related to long-term storage contracts which the Company has under license agreements. Contracted storage periods areannual, twenty-one years andlife-time. The life-time storage plan is based on a life expectancy of 81 years, which is the current estimate by the Center for Disease Control for United States women’s life expectancy and concluded that additional data analysis would result in an immaterial difference in revenue. Deferred revenue on the accompanying consolidated balance sheets includes the portion of the annual, the twenty-one-year and the life-time storage fees that are being recognized over the contractual storage period as well as royalties received from foreign licensees relating to long-term storage contracts for which the Company has future obligations under the license agreement. The Company classifies deferred revenue as current if the Company expects to recognize the related revenue over the next 12 months from the balance sheet date.
Significant financing component
When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. For all plans being annual, twenty-one years and lifetime, the storage fee is billed at the beginning of the storage period (prepaid plans). The Company also offers payment plans (including a stated service fee) for customers to pay over time for a period of one to twenty-four plus months. The one-time plan includes the collection kit, processing and testing, return medical courier service and twenty-one years of pre-paid storage fees. The life-time plan includes the collection kit, processing and testing, return medical courier service and pre-paid storage fees for the life of the customer. The Company concluded that a significant financing component is not present within either the prepaid or overtime payment plans. The Company has determined that the twenty-one year and life-time prepayment options do not include a significant financing component as the payment terms were structured primarily for reasons other than the provision of financing and to maximize profitability.
The Company has determined that the majority of plans that are paid over time are paid in less than a year. When considered over a twenty-four-month payment plan, the difference between the cash selling price and the consideration paid is nominal. As such, the Company believes that its payment plans do not include significant financing components as they are not significant in the aggregate when considered in the context of all contracts entered into nor significant at the individual contract level.
The Company elected to apply the practical expedient where the Company does not need to assess whether a significant financing component exists if the period between when it performs its obligations under the contract and when the customer pays is one year or less.
As of May 31, 2024, the total aggregate transaction price allocated to the unsatisfied performance obligations was recorded as deferred revenue amounting to $53,501,280, which will be recognized ratably on a straight-line basis over the contractual period of which $9,580,635, will be recognized over the next twelve months.
Variable consideration
In December 2005, the Company began providing its customers that enrolled after December 2005 a payment warranty under which the Company agrees to pay $50,000 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. Effective February 1, 2012, the Company increased the $50,000 payment warranty to a $75,000 payment warranty to all of its new clients. Effective June 1, 2017, the Company increased the payment warranty to $100,000 to all new clients who choose the premium processing method, PrepaCyte CB. The product warranty is available to clients who enroll under this structure for as long as the specimen is stored with the Company. In the processing and storage agreements, the Company provides limited rights which are offered to customers automatically upon contract execution. The Company has determined that the payment warranty represents variable consideration payable to the customer.
Based on the Company’s historical experience to date, the Company has determined the payment warranty to be fully constrained under the most likely amount method. Consequently, the transaction price does not currently reflect any expectation of service level credits. At the end of each reporting period, the Company will update the estimated transaction price related to the payment warranty including updating its assessment of whether an estimate of variable consideration is constrained to represent faithfully the circumstances present at the end of the reporting period and the changes in circumstances during the reporting period.
Allocation of transaction price
As the Company’s processing and storage agreements contain multiple performance obligations, ASC 606 requires an allocation of the transaction price based on the estimated relative standalone selling prices of the promised services underlying each performance obligation. The Company has selected an adjusted market assessment approach to estimate the stand-alone selling prices of the processing services and storage services and concluded that the published list price is the price that a customer in that market would be willing to pay for those goods or services. The Company also considered the fact that all customers are charged the list prices current at the time of their enrollment where the Company has separately stated list prices for processing and storage.
Costs to Obtain a Contract
The Company capitalizes commissions that are incremental in obtaining customer contracts and the costs incurred to fulfill a customer contract if those costs are not within the scope of another topic within the accounting literature and meet the specified criteria. These costs are deferred in other current or long-term assets and are expensed to selling, general and administrative expenses as the Company satisfies the performance obligations by transferring the service to the customer. These assets will be periodically assessed for impairment. As a practical expedient, the Company elected to recognize the incremental costs of obtaining its annual contracts as an expense when incurred, as the amortization period of the asset recognized would have beenone year.
The Company has determined that payments under the Company’s refer-a-friend program (“RAF program”) are incremental costs of obtaining a contract as they provide an incentive for existing customers to refer new customers to the Company and is referred to as commission. The amount paid under the RAF program (either through issuance of credits to customers or check payments) which exceeds the typical commission payment to a sales representative is recorded as a reduction to revenue under ASC 606. During the three and six months ended May 31, 2024, the Company recorded $14,441 and $25,493, respectively, in commission payments to customers under the RAF program as a reduction to revenue. During thethree and six months ended May 31, 2023, the Company recorded $10,958 and $21,390, respectively, in commission payments to customers under the RAF program as a reduction to revenue. For thethree and six months ended May 31, 2024 the Company capitalized additional contract acquisition costs of $31,490 and $61,669, respectively, net of amortization. For thethree and six months ended May 31, 2023, the Company capitalized additional contract acquisition costs of $28,512 and $54,948, respectively, net of amortization expense.
b)
Public banking revenue
The Company sells and provides units not likely to be of therapeutic use for research to qualified organizations and companies operating under Institutional Review Board approval. Control is transferred at the point in time when the shipment has occurred, at which time, the Company records revenue.
c)
Licensee and royalty income
Licensee and royalty income consist of royalty income earned on the processing and storage of cord blood stem cell specimens by an affiliate where the Company has a License and Royalty Agreement. The Company records revenue from processing and storage of specimens and pursuant to agreements with licensees. The Company records the royalty revenue in same period that the related processing and storage is being completed by the affiliate.
d)
Product Revenue
The Company records revenue from the sale of the PrepaCyte CB product line upon shipment of the product to the Company’s customers.
e)
Shipping and handling
The Company elected to apply the practical expedient to account for shipping and handling activities performed after the control of a good has been transferred to the customer as a fulfillment cost. Shipping and handling costs that the Company incurs are therefore expensed and included in cost of sales.
Disaggregation of Revenue
The revenue as reflected in the statements of income is disaggregated by products and services.
The following table provides information about assets and liabilities from contracts with customers:
| May 31, 2024 | November 30, 2023 | |
|---|---|---|
| Contract assets (sales commissions) | $738,555 | $695,695 |
| Accounts receivable | $6,831,447 | $6,576,240 |
| Short-term contract liabilities (deferred revenue) | $9,580,635 | $9,704,553 |
| Long-term contract liabilities (deferred revenue) | $43,920,645 | $41,186,800 |
The Company, in general, requires the customer to pay for processing and storage services at the time of processing. Contract assets include deferred contract acquisition costs, which will be amortized along with the associated revenue. Contract liabilities include payments received in advance of performance under the contract and are realized with the associated revenue recognized under the contract. Accounts receivable consists of amounts due from clients that have enrolled and processed in the umbilical cord blood stem cell processing and storage programs related to renewals of annual plans and amounts due from license affiliates, and sublicensee territories. The Company didnot have asset impairment charges related to contract assets in thethree and six months ended May 31, 2024.
The following table presents changes in the Company’s contract assets and liabilities during the six months ended May 31, 2024:
| Balance at December 1,2023 | Additions | Deductions | Balance at May 31,2024 | |
|---|---|---|---|---|
| Contract assets (sales commissions) | $695,695 | $61,669 | $(18,809) | $738,555 |
| Accounts receivable | $6,576,240 | $21,115,429 | $(20,860,222) | $6,831,447 |
| Contract liabilities (deferred revenue) | $50,891,353 | $10,803,662 | $(8,193,735) | $53,501,280 |
The following table presents changes in the Company’s contract assets and liabilities during the six months ended May 31, 2023:
| Balance at December 1,2022 | Additions | Deductions | Balance at May 31,2023 | |
|---|---|---|---|---|
| Contract assets (sales commissions) | $615,628 | $54,948 | $(16,460) | $654,116 |
| Accounts receivable | $6,043,941 | $21,299,426 | $(20,660,888) | $6,682,479 |
| Contract liabilities (deferred revenue) | $45,586,386 | $13,557,161 | $(11,035,497) | $48,108,050 |
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 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 Cord:Use 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 May 31, 2024, 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 36 blood units per year. 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 36 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 3).
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 of the future income tax benefits will not 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.
The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. Increases or decreases to the unrecognized tax benefits could result from management’s belief that a position can or cannot be sustained upon examination based on subsequent information or potential lapse of the applicable statute of limitation for certain tax positions.
The Company recognizes interest and penalties related to uncertain tax positions in income tax expense. For the six months ended May 31, 2024 and May 31, 2023, the Company hadno provisions for interest or penalties related to uncertain tax positions.
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 didnot note any impairment for thethree and six months ended May 31, 2024 and 2023.
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, intangible 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.
Leases
At the inception of a lease arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Leases with a term greater than one year are recognized on the balance sheet as a right-of-use (ROU) assets and as short-term and long-term lease liabilities, as applicable. The Company does not have any financing leases.
Operating lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining lease term. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate to discount lease payments, which reflects the fixed rate at which the Company believes it could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment.
The Company has elected not to recognize leases with an original term of one year or less on the balance sheet. The Company typically only includes an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew.
Stock Compensation
As of May 31, 2024, the Company has three stock-based compensation plans, which are described in Note 7 to the unaudited consolidated financial statements: the 2006 plan, 2012 plan and the 2022 Plan. The 2006 and 2012 Plans will remain in effect as long as any awards under the Plans are outstanding; however, no further awards may be granted under either plan. The 2022 Plan became effective April 8, 2022 as approved by the Board of Directors and approved by the stockholders at the 2022 Annual Meeting. The Company recognized approximately $485,000 and $470,000 for thesix months ended May 31, 2024 and May 31, 2023 respectively, of stock compensation expense. The Company recognized approximately $178,000 and $157,000 for thethree months ended May 31, 2024 and May 31, 2023, respectively, of stock option compensation expense.
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.
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.
Fair Value of Financial Instruments
Management uses a fair value hierarchy, which gives the highest priority to quoted prices in active markets. The fair value of financial instruments is estimated based on market trading information, where available. Absent published market values for an instrument or other assets, management uses observable market data to arrive at its estimates of fair value. Management believes that the carrying amount of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses approximate fair value due to the short-term nature of these instruments. The Company believes that the fair value of its Revenue Sharing Agreements (”RSAs”) liability recorded on the balance sheet is between the recorded book value and up to the Company’s previous settlement experience, due to the various terms and conditions associated with each RSA.
The Company uses an accounting standard that defines fair value as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the standard establishes a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. The three levels of inputs used to measure fair value are as follows:
Level 1 Quoted prices in active markets for identical assets or liabilities.
Level 2 Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.
Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs.
The following table summarizes the financial assets and liabilities measured at fair value on a recurring basis as of May 31, 2024 and November 30, 2023, respectively, segregated among the appropriate levels within the fair value hierarchy:
| Fair Value at · Fair Value Measurements at May 31, 2024 Using | ||||
|---|---|---|---|---|
| Description | May 31,2024 | Level 1 | Level 2 | Level 3 |
| Assets: | ||||
| Marketable securities | $1,060,436 | $1,060,436 | $— | $— |
| Total | $1,060,436 | $1,060,436 | $— | $— |
| Liabilities: | ||||
| Contingent consideration | $35,353 | $— | $— | $35,353 |
| Total | $35,353 | $— | $— | $35,353 |
| Contingent Consideration: | |
|---|---|
| Beginning Balance as of November 30, 2023 | $44,226 |
| Fair value adjustment as of May 31, 2024 | (8,873) |
| Ending balance as of May 31, 2024 | $35,353 |
| Fair Value at · Fair Value Measurements at November 30, 2023 Using | ||||
|---|---|---|---|---|
| Description | November 30,2023 | Level 1 | Level 2 | Level 3 |
| Assets: | ||||
| Marketable securities | $574,183 | $574,183 | $— | $— |
| Interest rate swap | $122,113 | $— | $122,113 | $— |
| Total | $696,296 | $574,183 | $122,113 | $— |
| Liabilities: | ||||
| Contingent consideration | $44,226 | $— | $— | $44,226 |
| Total | $44,226 | $— | $— | $44,226 |
The following is a description of the valuation techniques used for these items, as well as the general classification of such items pursuant to the fair value hierarchy:
Marketable securities - Equity securities with readily determinable fair values are measured at fair value with the changes in fair value recognized through net income. There was approximately $11,000 and $7,000 in unrealized holding gains, respectively, recorded in other income and expense on the accompanying consolidated statements of income for thethree and six months ended May 31, 2023, respectively. There was approximately $259,000 and $534,000 in unrealized holding gains, respectively, recorded in other income and expense on the accompanying consolidated statements of income for thethree and six months ended May 31, 2024, respectively
Interest rate swap - The fair value is based on prevailing market data and derived from proprietary models based on well recognized financial principles and reasonable estimates about relevant future market conditions. There was $151,175 and $105,887 gain on interest rate swap recorded on the accompanying statements of income for thethree and six months ended May 31, 2024. There was a $223,974 and 223,974 loss on interest rate swap recorded on the accompanying statements of income for thethree and six months ended May 31, 2023, respectively. On April 15, 2024, the Company terminated the interest rate swap agreement and recorded proceeds of $228,000.
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.
Product Warranty and Cryo-Cell Cares TM Program
In December 2005, the Company began providing its customers that enrolled after December 2005 a payment warranty under which the Company agrees to pay $50,000 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. Effective February 1, 2012, the Company increased the $50,000 payment warranty to a $75,000 payment warranty to all of its new clients. Effective June 1, 2017, the Company increased the payment warranty to $100,000 to all new clients who choose the premium processing method, PrepaCyte CB. The product warranty is available to clients who enroll under this structure for as long as the specimen is stored with the Company. The Company has not experienced any claims under the warranty program nor has it incurred costs related to these warranties.
As discussed above, the Company has determined that the payment warranty represents variable consideration payable to the customer. In accordance with ASC 606, the Company has concluded the payment warranty be fully constrained under the most likely amount method; therefore, the transaction price does not reflect any expectation of service level credits at May 31, 2024 and November 30, 2023. At the end of each reporting period, the Company shall update the estimated transaction price related to the payment guarantee including updating its assessment of whether an estimate of variable consideration is constrained to represent faithfully the circumstances present at the end of the reporting period and the changes in circumstances during the reporting period.
Recently Issued Accounting Pronouncements
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 provides guidance for estimating credit losses on certain types of financial instruments, including trade receivables, by introducing an approach based on expected losses. The expected loss approach will require entities to incorporate considerations of historical information, current information and reasonable and supportable forecasts. ASU 2016-13 also amends the accounting for credit losses on available-for-sale debt securities and purchased financial assets with credit deterioration. The guidance requires a modified retrospective transition method and early adoption is permitted. In November 2019, FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses, Derivatives and Hedging, and Leases (“ASU 2019-10”), which defers the adoption of ASU 2016-13 for smaller reporting companies until periods beginning after December 15, 2022. The Company adopted ASU 2016-13 as of December 1, 2023 with no material impact to its consolidated financial statements.
Note 2–Segment Reporting
The Company is organized inthree reportable segments:
The cellular processing and cryogenic storage of umbilical cord blood and cord tissue stem cells for family use. Revenue is generated from the initial processing and testing fees and the annual storage fees charged each year for storage (the “Umbilical cord blood and cord tissue stem cell service”).
The manufacture of PrepaCyte® CB units, the processing technology used to process umbilical cord blood stem cells. Revenue is generated from the sales of the PrepaCyte® CB units (the “PrepaCyte®-CB”).
The cellular processing and cryogenic storage of umbilical cord blood stem cells for public use. Revenue 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 following table shows, by segment: net revenue, cost of sales, depreciation and amortization, operating profit, and interest expense for thethree and six months ended May 31, 2024 and 2023:
| For the three months ended May 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Net revenue: | ||
| Umbilical cord blood and cord tissue stem cell service | $7,965,500 | $7,581,697 |
| PrepaCyte CB | 35,834 | 27,177 |
| Public cord blood banking | 41,477 | 163,816 |
| Total net revenue | $8,042,811 | $7,772,690 |
| Cost of sales: | ||
| Umbilical cord blood and cord tissue stem cell service | $1,830,453 | $1,802,882 |
| PrepaCyte CB | 10,380 | 9,328 |
| Public cord blood banking | 183,917 | 330,976 |
| Total cost of sales | $2,024,750 | $2,143,186 |
| Operating profit: | ||
| Umbilical cord blood and cord tissue stem cell service | $1,515,506 | $1,184,513 |
| PrepaCyte CB | 18,510 | 10,905 |
| Public cord blood banking | (142,498) | (167,520) |
| Total operating profit | $1,391,518 | $1,027,898 |
| Depreciation and amortization: | ||
| Umbilical cord blood and cord tissue stem cell service | $52,796 | $273,776 |
| PrepaCyte CB | 6,944 | 6,944 |
| Public cord blood banking | 58 | 360 |
| Total depreciation and amortization | $59,798 | $281,080 |
| Interest expense: | ||
| Umbilical cord blood and cord tissue stem cell service | $329,273 | $469,952 |
| PrepaCyte CB | — | — |
| Public cord blood banking | — | — |
| Total interest expense | $329,273 | $469,952 |
| For the six months ended May 31, | ||
| 2024 | 2023 | |
| Net revenue: | ||
| Umbilical cord blood and cord tissue stem cell service | $15,771,022 | $15,143,215 |
| PrepaCyte CB | 38,834 | 59,377 |
| Public cord blood banking | 85,190 | 394,513 |
| Total net revenue | $15,895,046 | $15,597,105 |
| Cost of sales: | ||
| Umbilical cord blood and cord tissue stem cell service | $3,715,019 | $3,490,132 |
| PrepaCyte CB | 35,863 | 26,450 |
| Public cord blood banking | 434,336 | 693,968 |
| Total cost of sales | $4,185,218 | $4,210,550 |
| Operating profit: | ||
| Umbilical cord blood and cord tissue stem cell service | $2,573,225 | $2,992,206 |
| PrepaCyte CB | (10,918) | 19,038 |
| Public cord blood banking | (349,566) | (300,175) |
| Total operating profit | $2,212,741 | $2,711,069 |
| Depreciation and amortization: | ||
| Umbilical cord blood and cord tissue stem cell service | $78,675 | $547,315 |
| PrepaCyte CB | 13,889 | 13,889 |
| Public cord blood banking | 420 | 720 |
| Total depreciation and amortization | $92,984 | $561,924 |
| Interest expense: | ||
| Umbilical cord blood and cord tissue stem cell service | $585,732 | $936,183 |
| PrepaCyte CB | — | — |
| Public cord blood banking | — | — |
| Total interest expense | $585,732 | $936,183 |
The following table shows the assets by segment as of May 31, 2024 and November 30, 2023:
| As of | As of | |
|---|---|---|
| May 31, 2024 | November 30, 2023 | |
| Assets: | ||
| Umbilical cord blood and cord tissue stem cell service | $56,915,873 | $55,471,149 |
| PrepaCyte CB | 111,921 | 148,040 |
| Public cord blood banking | 5,538,802 | 5,601,581 |
| Total assets | $62,566,596 | $61,220,770 |
Note 3 – Inventory
Inventory is comprised of public cord blood banking specimens, collection kits, finished goods, work-in-process and raw materials. Collection kits are used in the collection and processing of umbilical cord blood and cord tissue stem cells, finished goods include products purchased or assumed for resale and for the use in the Company’s processing and storage service. Inventory in the Public Cord Blood Bank includes finished goods that are specimens that are available for resale. The Company considers Public Cord Blood Inventory in the Public Cord Blood Bank that has not completed all testing to determine viability to be work in process.
The components of inventory at May 31, 2024 and November 30, 2023 are as follows:
| As ofMay 31, 2024 | As ofNovember 30, 2023 | |
|---|---|---|
| Raw materials | $— | $— |
| Work-in-process | 313,816 | 341,692 |
| Work-in-process – Public Bank | — | — |
| Finished goods | 16,171 | 48,045 |
| Finished goods – Public Bank | 5,537,467 | 5,599,238 |
| Collection kits | 46,532 | 47,739 |
| Inventory reserve | (7,718) | (7,718) |
| Total inventory | $5,906,268 | $6,028,996 |
Note 4 – Intangible Assets
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.
Intangible assets were as follows as of May 31, 2024 and November 30, 2023:
| Useful lives | May 31, 2024 | November 30, 2023 | |
|---|---|---|---|
| Patents | 10-20 years | $697,744 | $697,744 |
| Less: Intangible asset impairment | $(377,810) | $(377,810) | |
| Less: Accumulated amortization | (166,247) | (160,434) | |
| License agreement | 10 years | 474,000 | 474,000 |
| Less: Intangible asset impairment | (185,000) | (185,000) | |
| Less: Accumulated amortization | (260,331) | (248,607) | |
| Customer relationships – PrepaCyte®CB | 15 years | 41,000 | 41,000 |
| Less: Intangible asset impairment | (26,267) | (26,267) | |
| Less: Accumulated amortization | (9,902) | (9,505) | |
| Brand | 1 year | 31,000 | 31,000 |
| Less: Accumulated amortization | (31,000) | (31,000) | |
| Customer relationships – Cord:Use | 30 years | 960,000 | 960,000 |
| Less: Accumulated amortization | (192,000) | (176,000) | |
| Net Intangible Assets | $955,187 | $989,121 |
Amortization expense of intangibles was approximately $17,000 and $24,000 for thethree months ended May 31, 2024 and May 31, 2023, respectively. Amortization expense of intangibles was approximately $34,000 and $48,000 for thesix months ended May 31, 2024 and May 31, 2023.
Note 5 – Notes Payable
On July 18, 2022, the Company entered into a Credit Agreement (“Agreement Susser”) with Susser Bank, a Texas state bank, as administrative agent (“Susser”) on behalf of itself and the other lenders (collectively, the “Lenders”) for (i) an unsecured revolving line of credit in an aggregate principal amount of up to $10,000,000 (the “RCF”); and (ii) a term loan facility in an original principal amount of $8,960,000 (the “Term Loan Susser” and together with the RCF collectively, the “Loans”). In connection with the RCF the Company entered into a Revolving Credit Line, in favor of Susser, in the stated principal amount of $10,000,000 (the “RCF Note”), and in connection with the Term Loan the Company entered into a Term Note, in favor of Susser, in the stated principal amount of $8,960,000 (the “Term Note” and together with RCF Note, collectively, the “Notes”). The Loans bear interest at the Company’s option at: (a) the Base Rate, which is the highest of (i) the rate of interest published by The Wall Street Journal, from time to time, as the “U.S. Prime Rate”, (ii) the federal funds rate plus 0.5% and (iii) the Monthly SOFR rate plus 1.0% (subject in each case to a floor of 5.5%), plus 4.25% or (b) the Monthly SOFR plus 3.25% (subject to a floor of 4.5%). The RCF matures on July 18, 2025 and the Term Note matures on July 18, 2032. As of thethree months ended May 31, 2024 and May 31, 2023, the Company paid interest of $252,543 and $204,206, respectively, which is reflected in interest expense on the accompanying consolidated statements of income. As of thesix months ended May 31, 2024 and May 31, 2023, the Company paid interest of $455,802 and $406,681, respectively, which is reflected in interest expense on the accompanying consolidated statements of income. The interest rates for the RCF and Term Note as of May 31, 2024 were 8.57% and 8.57%, respectively.
The average outstanding balance during the six months ended May 31, 2024 for the revolving line of credit was $2,624,641. The average outstanding balance during the twelve months ended November 30, 2023 for the revolving line of credit was $1,848,344. The revolving line of credit balance as of May 31, 2024 and November 30, 2022 was $4,222,728 and $1,222,728, respectively, and is reflected on the accompanying balance sheet.
The Company incurred debt issuance costs related to the term loan in the amount of $196,501 which is recorded as a direct reduction of the carrying amount of the note payable and amortized over the life of the loan. As of thethree months ended May 31, 2024 and May 31, 2023, $5,322 and $5,418, respectively, of the debt issuance costs were amortized and are reflected in interest expense on the accompanying consolidated statements of income. As of thesix months ended May 31, 2024 and May 31, 2023, $10,670 and $10,862, respectively, of the debt issuance costs were amortized and are reflected in interest expense on the accompanying consolidated statements of income.
On March 27, 2023, the Company entered into an interest rate swap agreement with Susser to manage exposure to interest rate risk related to its variable rate debt obligation under the Term Note. The swap agreement had a notional amount equal to the Term Loan. The agreement is to pay the Company monthly SOFR plus 3.25% on the notional amount and the Company is to pay a fixed rate of interest equal to 6.96%. The effective date of the amended term loan was March 27, 2023 with a maturity date of July 29, 2032. On April 15, 2024, the Company terminated the interest rate swap agreement and recorded proceeds of $228,000.
The Company is required to pay a commitment fee equal to 0.5% times the daily average unused portion of the RCF.
The Agreement requires the Company to maintain a Leverage Ratio, determined as of the last day of each quarter for the four-fiscal quarter period ending on the date of determination, of no more than 3.50 to 1.00. The Agreement also requires the Company to maintain a Debt Service Coverage Ratio of no less than 1.25 to 1.00 determined as of the last day of each quarter for the four-fiscal quarter period ending on the date of determination.
As of May 31, 2024 and November 30, 2023, the note payable obligation was as follows:
| May 31, 2024 | November 30, 2023 | |
|---|---|---|
| Note payable - Susser | $8,686,712 | $8,765,082 |
| Unamortized debt issuance costs - Susser | (158,735) | (169,404) |
| Net note payable | $8,527,977 | $8,595,678 |
| Current portion of note payable | $171,605 | $165,641 |
| Long-term note payable, net of debt issuance costs | 8,356,372 | 8,430,037 |
| Total | $8,527,977 | $8,595,678 |
Interest expense on the note payable for thethree and six months ended May 31, 2024 and 2023 was as follows:
| For the three months ended | For the six months ended | |
|---|---|---|
| May 31, 2024 | May 31, 2024 | |
| Interest expense on notes payable - Susser | $47,166 | $47,166 |
| Debt issuance costs - Susser | — | — |
| Total interest expense | $47,166 | $47,166 |
| For the three months ended | For the six months ended | |
| May 31, 2023 | May 31, 2023 | |
| Interest expense on notes payable - Susser | $204,206 | $406,681 |
| Debt issuance costs - Susser | 5,418 | 10,862 |
| Total interest expense | $209,624 | $417,543 |
During the three and six months ended May 31, 2024, the Company capitalized interest expense of $210,700 and $409,307, respectively, related to the construction of the Company's new facility in North Carolina.
Note 6 – Income per Common Share
The following table sets forth the calculation of basic and diluted net income per common share:
| Three Months Ended | Six Months Ended | |||
|---|---|---|---|---|
| May 31, 2024 | May 31, 2023 | May 31, 2024 | May 31, 2023 | |
| Numerator: | ||||
| Net income | $655,790 | $220,976 | $1,212,031 | $987,788 |
| Denominator: | ||||
| Weighted-average shares outstanding-basic | 8,117,479 | 8,325,101 | 8,197,223 | 8,395,307 |
| Dilutive common shares issuable upon exercise of stock options | 114,848 | 6,810 | 78,191 | 7,231 |
| Weighted-average shares-diluted | 8,232,327 | 8,331,911 | 8,275,414 | 8,402,538 |
| Income per share: | ||||
| Basic | $0.08 | $0.03 | $0.15 | $0.12 |
| Diluted | $0.08 | $0.03 | $0.15 | $0.12 |
For the three months ended May 31, 2024, the Company excluded the effect of 527,700 outstanding options from the computation of diluted earnings per share, as the effect of potentially dilutive shares from the outstanding stock options would be anti-dilutive. For thesix months ended May 31, 2024, the Company excluded the effect of 639,745 outstanding options from the computation of diluted earnings per share, as the effect of potentially dilutive shares from the outstanding stock options would be anti-dilutive.
For the three months ended May 31, 2023, the Company excluded the effect of 843,678 outstanding options from the computation of diluted earnings per share, as the effect of potentially dilutive shares from the outstanding stock options would be anti-dilutive. For thesix months ended May 31, 2023, the Company excluded the effect of 843,678 outstanding options from the computation of diluted earnings per share, as the effect of potentially dilutive shares from the outstanding stock options would be anti-dilutive.
Note 7 – Stockholders’ Equity
Employee Stock Incentive Plan
The Company maintains the 2006 Stock Incentive Plan (the “2006 Plan”) under which it has reserved 1,000,000 shares of the Company’s common stock for issuance pursuant to stock options, restricted stock, stock-appreciation rights (commonly referred to as “SARs”) and stock awards (i.e., performance options to purchase shares and performance units). As of May 31, 2024, and November 30, 2023, there were 17,500 and 17,500 options issued, but not yet exercised, under the 2006 Plan, respectively. As of May 31, 2024, there wereno shares available for future issuance under the 2006 Plan.
The Company maintains the 2012 Equity Incentive Plan (the “2012 Plan”) which became effective December 1, 2011 as approved by the Board of Directors and approved by the stockholders at the 2012 Annual Meeting on July 10, 2012. The 2012 Plan originally reserved 1,500,000 shares of the Company’s common stock for issuance pursuant to stock options, restricted stock, SARs, and other stock awards (i.e., performance shares and performance units). In May 2012, the Board of Directors approved an amendment to the 2012 Plan to increase the number of shares of the Company’s common stock reserved for issuance to 2,500,000 shares. In October 2019, the Board of Directors approved amendments to the plan, subject to ratification by the stockholders, which occurred at the Company’s 2019 Annual Meeting of Stockholders on November 21, 2019. As of May 31, 2024, there were 198,578 service-based options issued,129,729 service-based restricted common shares granted,530,851 performance-based and 116,218 market-based restricted common shares granted under the 2012 Plan. As of November 30, 2023, there were 198,578 service-based options issued,129,729 service-based restricted common shares granted,530,851 performance-based and 116,218 market-based restricted common shares granted under the 2012 Plan. As of May 31, 2024, there wereno shares available for future issuance under the 2012 Plan.
On April 8, 2022, the Board of Directors of the Company adopted the 2022 Equity Incentive Plan (the “2022 Plan”) to provide incentive compensation to the Company’s employees, independent directors and independent contractors. The plan was approved by the Company's stockholders on October 3, 2022 at the Company’s 2022 Annual Meeting. The 2022 Plan reserves 1,500,000 shares of the Company’s common stock for issuance pursuant to stock options, restricted stock, SARs, and other stock awards (i.e., performance shares and performance units). As of May 31, 2024, there were 289,700 service-based options issued and 475,000 market-based restricted options granted. As of November 30, 2023, there were 186,700 service-based options issued and 475,000 market-based restricted options granted. As of May 31, 2024, there were 735,300 shares available for future issuance under the 2022 Plan.
Service-based vesting condition options
The fair value of each option award is estimated on the date of the grant using the Black-Scholes valuation model that uses the assumptions noted in the following table. Expected volatility is based on the historical volatility of the Company’s stock over the most recent period commensurate with the expected life of the Company’s stock options. The Company uses historical data to estimate option exercise and employee termination within the valuation model. The risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. The expected term of options granted to employees is based upon historical exercise data. Expected dividends are based on the historical trend of the Company not issuing dividends.
There were 0 and 103,000 options granted during thethree and six months ended May 31, 2024, respectively.
There were 0 and 113,00 options granted during thethree and six months ended May 31, 2023, respectively.
Variables used to determine the fair value of the options granted for thethree and six months ended May 31, 2024 and 2023, respectively, are as follows:
| Three months ended | Six months ended | |||
|---|---|---|---|---|
| May 31, | May 31, | May 31, | May 31, | |
| 2024 | 2023 | 2024 | 2023 | |
| Weighted average values: | ||||
| Expected dividends | 0% | 0% | 0% | 0% |
| Expected volatility | — | — | 60.52% | 55.00% |
| Risk free interest rate | — | — | 3.87% | 3.87% |
| Expected life | — | — | 5 years | 5 years |
Stock option activity for options with only service-based vesting conditions for thesix months ended May 31, 2024, was as follows:
| Weighted · WeightedAverageRemaining | ||||||
|---|---|---|---|---|---|---|
| Average · Contractual · Aggregate | ||||||
| Options · ExercisePrice · Term(Years) · IntrinsicValue | ||||||
| Outstanding at November 30, 2023 | 404,278 | $7.36 | 4.49 | $135,330 | ||
| Granted | 103,000 | 6.31 | 196,770 | |||
| Exercised | — | — | — | |||
| Expired/forfeited | (1,500) | 7.04 | 1,770 | |||
| Outstanding at May 31, 2024 | 505,778 | $7.14 | 4.11 | $884,103 | ||
| Exercisable at May 31, 2024 | 375,718 | $7.50 | 4.06 | $594,908 | ||
The weighted average grant date fair value of options granted during the six months ended May 31, 2024 and May 31, 2023 was$3.13 and $2.19, respectively.
The aggregate intrinsic value represents the total value of the difference between the Company’s closing stock price on the last trading day of the period and the exercise price of the options, multiplied by the number of in-the-money stock options that would have been received by the option holders had all option holders exercised their options on either May 31, 2024 or November 30, 2023 as applicable. The intrinsic value of the Company’s stock options changes based on the closing price of the Company’s stock.
During the three and six months ended May 31, 2024, the Company didnot issue any common shares to option holders.
During the three and six months ended May 31, 2023, the Company didnot issue any common shares to option holders.
Significant option groups outstanding and exercisable at May 31, 2024 and related price and contractual life information are as follows:
| Outstanding · Exercisable | |||||
|---|---|---|---|---|---|
| WeightedAverage | |||||
| Remaining · Weighted · Weighted | |||||
| Range of Exercise Prices | Outstanding | ContractualLife(Years) | AverageExercisePrice | Outstanding | AverageExercisePrice |
| $3.01 to $4.00 | 25,000 | 1.69 | $3.13 | 25,000 | $3.13 |
| $4.01 to $5.00 | 123,600 | 4.09 | $4.70 | 78,665 | $4.68 |
| $5.01 to $6.00 | 28,000 | 4.56 | $5.88 | 9,332 | $5.88 |
| $6.01 to $7.00 | 89,433 | 4.91 | $6.48 | 39,430 | $6.48 |
| $7.01 to $8.00 | 149,645 | 4.86 | $7.54 | 142,443 | $7.52 |
| $9.01 to $10.00 | 29,000 | 3.76 | $9.37 | 21,583 | $9.37 |
| $12.01 to $13.00 | 16,653 | 6.23 | $12.54 | 14,818 | $12.55 |
| $13.01 to $14.00 | 44,447 | 0.56 | $13.50 | 44,447 | $13.50 |
| 505,778 | 4.11 | $7.14 | 375,718 | $7.50 | |
A summary of the status of the Company’s non-vested options as of May 31, 2024, and changes during the six months ended May 31, 2024, is presented below:
| WeightedAverage | ||
|---|---|---|
| Grant-Date | ||
| Options | Fair Value | |
| Non-vested at November 30, 2023 | 114,193 | $3.10 |
| Granted | 103,000 | 3.13 |
| Vested | (87,133) | 3.30 |
| Forfeited | — | — |
| Non-vested at May 31, 2024 | 130,060 | $2.99 |
As of May 31, 2024, there was approximately $324,000 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the 2006 Plan, 2012 Plan and the 2022 Plan. The cost is expected to be recognized over a weighted-average period of 1.94 years as of May 31, 2024. The total fair value of shares vested during the six months ended May 31, 2024 was approximately $288,000.
Performance and market-based vesting condition options
On April 8, 2022, the Company granted 400,000 market-based vesting condition options to David Portnoy, Mark Portnoy, and Oleg Mikulinsky in the amounts of 280,000,100,000, and 20,000, respectively. For market-based vesting condition options, accounting principles do not require that the market condition be met in order for the compensation cost to be recognized. Fair value of these options has been determined using a Monte Carlo valuation approach and is being recognized over the requisite service period, regardless if the market condition will be met. The exercise price of the options is $12.27 and the calculated fair value of the options is $2.79. These stock options vest immediately when the price of the Company's stock reaches $25.00 per share during theseven-year option term. The grant of these options was approved by the Company's stockholders on October 3, 2022 at the Company’s 2022 Annual Meeting. For thesix months ended May 31, 2024 and May 31, 2023, the Company recognized approximately $196,000 and $195,000, respectively, in compensation cost and is reflected as selling, general and administrative expense in the accompanying consolidated statement of income. As of May 31, 2024, there was approximately $276,000 of unrecognized compensation cost to be recognized over the remaining requisite service period of.72 years.
On December 23, 2022, the Company entered into newtwo-year employment agreements (the "Agreements"), effective December 1, 2022, with David Portnoy and Mark Portnoy. Per the Agreements, David Portnoy and Mark Portnoy were awarded a signing bonus of a 5-year option to acquire 50,000 and 25,000 shares, respectively, of the Company's common stock, exercisable only if the Company's stock has a closing price at least once during the life of the option above $8.00. These options are considered to be market-based vesting condition options and accounting principles do not require the market condition to be met in order for the compensation cost to be recognized. Fair value of these options has been determined using a Monte Carlo valuation approach and is being recognized over the requisite service period, regardless if the market condition will be met. The exercise price of the options is $4.30 and the calculated fair value of the options is $1.76. These stock options vest immediately when the price of the Company's stock reaches $8.00 per share during thefive-year option term. The price of the Company's stock reached above $8.00 on March 26, 2024. As a result, the stock options vested immediately and the remaining compensation cost was recognized. As of thesix months ended May 31, 2024 and May 31, 2023, the Company recognized approximately $52,000 and $37,000, respectively, in compensation cost and is reflected as selling, general and administrative expense in the accompanying consolidated statement of income. As of May 31, 2024, there was approximately $0 of unrecognized compensation cost to be recognized over the remaining service period of.10 years.
Note 8 – License Agreements
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.
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.
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 and Panama.
Note 9 – Commitments and Contingencies
Employment Agreements
The Company has employment agreements in place for certain members of management. These employment agreements are for periods ranging fromone totwo years and contain certain provisions for severance payments in the event of certain events, including termination or change of control.
Legal Proceedings
On January 6, 2023, a complaint styled Lindsey Lehr v. Cryo-Cell International, Inc., Case No. 50-2023-CA-000091, was filed in the Circuit Court for Palm Beach County, Florida, naming the Company as defendant and asserting claims on behalf of a putative class of individuals who entered agreements with the Company for umbilical cord blood storage services since May 2018. The complaint alleged that the Company’s advertising does not accurately represent the value and efficacy of its services and asserted claims (and sought unspecified damages) under Florida law. On March 14, 2023, the Company removed the case to the United States District Court for the Southern District of Florida (Case No. 9:23-cv-80405-AMC), and on March 21, 2023, moved to compel arbitration and stay the case. On October 10, 2023, the Court granted the Company’s motion to compel arbitration and stayed the case. On October 27, 2023, the plaintiff filed a demand for arbitration and statement of claims with the American Arbitration Association, and on January 18, 2024, the plaintiff filed an amended statement of claims dropping her class action allegations against the Company. On March 19, 2024, the Company filed an answering statement and counterclaim in response to the plaintiff’s claims. The Company believes the plaintiff’s claims are unlikely to prevail and intends to contest the action vigorously. The Company believes that the resolution of this matter 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 outcome or resolution of the claims asserted, which could negatively and materially impact the Company’s business, consolidated financial position and results of operations. 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.
In addition to the above lawsuit, from time to time, the Company is subject to proceedings, lawsuits, contract disputes and other claims in the normal course of its business.
Note 10 – Share Repurchase Plan
In December 2011, the Company’s Board of Directors authorized management at its discretion to repurchase up to one million (1,000,000) shares of the Company's outstanding common stock. On June 6, 2012, the Board of Directors of the Company increased the number of shares of the Company’s outstanding common stock that management is authorized to repurchase to up to three million (3,000,000). On April 8, 2015, the Board of Directors of the Company increased the number of shares of the Company’s outstanding common stock that management is authorized to repurchase to up to nine million (6,000,000) shares. On October 6, 2016, the Board of Directors of the Company increased the number of shares of the Company’s outstanding common stock that management is authorized to repurchase to up to eight million (8,000,000) shares. The repurchases must be effectuated through open market purchases, privately negotiated block trades, unsolicited negotiated transactions, and/or pursuant to any trading plan that may be adopted in accordance with Rule 10b5-1 of the Securities and Exchange Commission or in such other manner as will comply with the provisions of the Securities Exchange Act of 1934.
As of May 31, 2024, the Company had repurchased an aggregate of 6,785,460 shares of the Company’s common stock at an average price of $3.66 per share through open market and privately negotiated transactions under the Company’s share repurchase plan. The Company purchased 222,999 shares (at an average price of $6.31 per share) during thesix months ended May 31, 2024 and the Company purchased 213,342 shares (at an average price of $3.71 per share) of the Company’s common stock during thesix months ended May 31, 2023.
The repurchased shares will be held as treasury stock at cost and have been removed from common shares outstanding as of May 31, 2024 and November 30, 2023. As of May 31, 2024 and November 30, 2023,6,785,460 and 6,562,461 shares, respectively, were held as treasury stock.
Subsequent to the balance sheet date May 31, 2024, the Company repurchased 2,000 of additional shares of the Company’s common stock, at an average price of $8.20 per share.
Note 11 – Leases
The following table presents the right-of-use asset and short-term and long-term lease liabilities amounts recorded on the consolidated balance sheets as of May 31, 2024 and November 30, 2023:
| May 31,2024 | November 30,2023 | |
|---|---|---|
| Assets | ||
| Operating lease right-of-use asset | $881,744 | $1,033,157 |
| Liabilities | ||
| Current portion of operating lease liabilities | $294,777 | $225,686 |
| Operating lease long-term liabilities | 672,339 | 851,938 |
| Total lease liability | $967,116 | $1,077,624 |
The maturity of the Company’s lease liabilities at May 31, 2024 were as follows:
| Future Operating | |
|---|---|
| Fiscal Year Ending November 30, | Lease Payments |
| 2024 (6 months remaining) | $153,381 |
| 2025 | 435,970 |
| 2026 | 458,026 |
| 2027 | 38,247 |
| Less: Imputed interest | (118,508) |
| Present value of lease liabilities | $967,116 |
The remaining lease term and discount rates are as follows:
| May 31,2024 | November 30,2023 | |
|---|---|---|
| Lease Term and Discount Rate | ||
| Remaining lease term (years) | ||
| Operating lease | 2.58 | 3.08 |
| Discount rate (percentage) | ||
| Operating lease | 8.3% | 8.3% |
Supplemental cash flow information related to leases is as follows:
| Three months ended | ||
|---|---|---|
| May 31,2024 | May 31,2023 | |
| Operating cash outflows from operating leases | $88,743 | $88,918 |
| Six months ended | ||
| May 31,2024 | May 31,2023 | |
| Operating cash outflows from operating leases | $178,097 | $177,313 |
Note 12 – License Agreement with Duke
On February 23, 2021, the Company entered into a Patent and Technology License Agreement (the “Duke Agreement”) with Duke University ("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 Duke Agreement was amended pursuant to the First Amendment to License Agreement dated February 4, 2022 (the “First Duke Amendment”) and the Second Amendment to License Agreement dated February 17, 2023 (the “Second Duke Amendment”).
Duke has completed or is in the progress of completing a total of 19 FDA approved clinical trials related to the Duke License Agreement. The Company intends to fund additional clinical trials, as necessary, to provide the proof of efficacy that is required by the FDA to issue BLAs for some or all of the indications mentioned above.
In addition, Duke has provided its manufactured mesenchymal stem cells (MSCs) for one arm of a four arm, placebo controlled, multi-site, double blinded Phase 3 clinical trial, run by Emory University to treat osteoarthritis of the knee, in which cells from three different sources are compared to the current standard of care. The results did not show any benefit from any of the sources compared to the current standard of care.
The Company purchased a 56,000 square feet facility in Durham in which it plans to open the Cryo-Cell Institute for Cellular Therapies. Previously, the FDA granted Duke the right to treat certain patients with infusions of cord blood under its Expanded Access Program. In November 2023, Duke University transferred to the Company an Investigational New Drug (IND) relating to the use of umbilical cord blood to treat children with cerebral palsy. In February 2024, the Company submitted the protocol related to a Phase 3 clinical trial under this IND utilizing allogeneic umbilical cord blood to treat children with cerebral palsy and requested Regenerative Medicine Advanced Therapy (RMAT) designation.
The Duke 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.
In accordance with the original Duke Agreement, the Company was required to pay Duke a license fee equal to $12,000,000, of which $10,000,000 has been paid to date and an additional $2,000,000 was due on February 23, 2023. 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 obligated to pay certain legal fees and expenses associated with related patents.
On February 17, 2023, Company entered into a Second Amendment to the License Agreement (the “Second Amendment”) with Duke, as previously disclosed in the Company’s Form 10-K filed on February 28, 2023. The Second Amendment changes the license fee due to Duke. The final payment of $2,000,000 was due on February 23, 2023. The Second Amendment added a new milestone payment upon FDA approval of the first licensed product comprising cord tissue derived MSC (“ctMSC”) for autism spectrum disorder. The Second Amendment also added a new ctMSC milestone that the Company will open a manufacturing facility for the licensed product prior to the initiation of a Phase III clinical trial using ctMSC’s. As part of the Second Amendment, on March 3, 2023, the Company entered into the Clinical Study and Research Agreement (the “Research Agreement”) with Duke to provide funding to complete the Duke IMPACT Study ("the Study"). The Second Amendment allocated the $2,000,000 required payment toward the funding and completion of the Study. In consideration for the work to be performed under the Research Agreement, the Company is obligated to make a total of 14 payments of $187,407 commencing in March 2023 and a final payment of $187,400 upon the submission of a draft proposed publication for peer review and delivered to the Company of the completed IMPACT Study. Duke agreed this will be no later than September 30, 2024. The additional costs to be incurred above $2 million represent additional consideration payable to Duke under the Research Agreement. The nature of these costs is the outsourcing of funding for research and development (R&D) of the licensed product. The Data Safety Monitoring Board for the IMPACT Study recently has determined that the trial’s targeted accrual has been reached and consists of 137 patients.
Pursuant to the original Duke Agreement, unless the Duke Agreement is terminated or renegotiated as permitted per the Duke Agreement, the Company is also required to pay Duke minimum annual royalties beginning on the second anniversary of the effective date 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:
$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;
(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 18 months of February 23, 2021; and
o
Equal to or greater than $500,000,000, provided such trigger occurs within 24 months of February 23, 2021.
The First Amendment changed the requirements of the Company with regard to the minimum annual royalties payable to Duke. As amended, the minimum annual royalties are as follows:
Year 3: $500,000
Year 4: $1,000,000
Year 5: $2,500,000
Year 6 and each year thereafter during the term of this Agreement: $5,000,000
The Amendment also changed the requirements of the Company to pay Duke certain milestone payments, as follows:
$2,000,000 two years after the first patient or subject is treated in the first Phase III clinical trial of a licensed product comprising cord tissue derived MSC for an indication other than Autism Spectrum Disorder.
During the first quarter of fiscal 2021, the Company capitalized $15,372,382 as a Duke Agreement which was considered to be an asset acquisition and which represented the costs to obtain the Duke Agreement, and also recorded a corresponding liability to Duke for the Duke Agreement. The costs that were capitalized as a Duke license agreement includes the present value of the $12,000,000 license fee, $3,585,172, or 409,734 shares, of the Company’s common stock transferred to Duke and certain acquisition costs. The Company is amortizing these costs over 16 years. As of thesix months ended May 31, 2024 and May 31, 2023, the Company recorded $0 and $480,387, respectively, in amortization expense which is reflected in amortization expense on the accompanying consolidated statements of income. As of thethree months ended May 31, 2024 and May 31, 2023, the Company recorded $0 and $240,194, respectively, in amortization expense which is reflected in amortization expense on the accompanying consolidated statements of income.
During fiscal 2023, the Company recognized that there were indications of impairment of the assets associated with the Duke license agreement. The Company evaluated the triggering events that existed as of November 30, 2023, tested the asset group for recoverability and measured the long-lived asset impairment. During the fourth quarter of fiscal 2023, the results were received from a phase 2/3 trial to treat osteoarthritis of the knee conducted to compare the effectiveness of an injection of a corticosteroid control to mesenchymal stem cell (MSC) preparations from autologous bone marrow concentrate (BMAC), adipose derived stem cells in the form of Stromal Vascular Fraction (SVF), and third-party human mesenchymal stem cells manufactured from umbilical cord tissue at Duke University for the treatment of unilateral Knee Osteoarthritis (OA). No benefit was shown from any of the sources compared to the current standard of care. Given these results (that included the Duke MSCs to which the Company licensed the exclusive rights) and other factors, it was determined that the uncertain future cash flows from the Duke license agreement may not be enough to recover the carrying value of the asset resulting in a fully impaired asset. During the fourth quarter of fiscal 2023, the Company recorded an impairment charge of the full carrying value of $13,108,064.
Through this Agreement, the Company intends to expand to a triad of core business units to include: (1) its cord blood bank and other storage services; (2) cord blood and cord tissue infusion clinic services initially under the FDA’s Expanded Access Program and in conjunction with the undertaking of cord blood and cord tissue clinical trials to obtain BLA approvals for new indications, and (3) biopharmaceutical manufacturing if BLA(s) are approved by the FDA. Due to equipment delivery delays, the Company is projecting to open the Cryo-Cell Institute for Cellular Therapies and begin infusing patients during fiscal 2024.
The Company entered into a Master Services Agreement with Emmes Biopharma Services LLC ("Emmes") serving as the Company's contract research organization, to conduct a phase 3 clinical trial infusing allogeneic umbilical cord blood into children with cerebral palsy. In consideration for the services to be rendered by Emmes, the Company will make payments in accordance with the budget and payment scheduled outlined in the work order. The period of performance is November 1, 2023 through April 6, 2028. The total fees will be $6,352,291. Included in the total fees is a $100,000 payment due upon execution and a monthly management fee of $21,862 per month payable for 53 months commencing during the first quarter of 2024. As of thethree months ended May 31, 2024 and May 31, 2023, the Company recorded clinical trial expenses of $87,849 and $0, respectively, and are reflected in research, development and related engineering expenses on the accompanying consolidated statements of income. As of thesix months ended May 31, 2024 and May 31, 2023, the Company recorded clinical trial expenses of $181,948 and $0, respectively, and are reflected in research, development and related engineering expenses on the accompanying consolidated statements of income. The total cost of the trial is currently estimated at $20 million.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.