CUMBERLAND PHARMACEUTICALS INC
For the period ended Dec 31, 2024. Filed Mar 7, 2025.
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FY2024 · Filed Mar 7, 2025
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Notes to Consolidated Financial Statements
(1)Organization
Cumberland Pharmaceuticals Inc. (“Cumberland,” the “Company,” or as used in the context of “we,” “us,” or “our”) is a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company’s primary target markets are hospital acute care, gastroenterology and oncology. These medical specialties are characterized by relatively concentrated prescriber bases that the Company believes can be penetrated effectively by small, targeted sales forces. Cumberland is dedicated to providing innovative products that improve quality of care for patients and address unmet or poorly met medical needs. The Company promotes its approved products through its hospital, field and oncology sales forces in the United States and is establishing a network of international partners to bring its medicines to patients in their countries.
Cumberland focuses its resources on maximizing the commercial potential of its products, as well as developing new product candidates, and has both internal development and commercial capabilities. The Company’s products are manufactured by third parties, which are overseen by Cumberland’s quality and manufacturing professionals. The Company works closely with its third-party distribution partners to make its products available in the United States.
In order to build a pipeline of early-stage product candidates, the Company formed a subsidiary, Cumberland Emerging Technologies, Inc. ("CET"), which teams with universities and other research organizations to help advance scientific discoveries from the laboratory to the marketplace.
In April, 2019, CET entered into an agreement with HongKong WinHealth Pharma Group Co. Limited ("WinHealth") whereby WinHealth made a $1.0 million investment through the purchase of shares of CET stock. As part of the agreement, WinHealth obtained a board position at CET and the first opportunity to license CET products for the Chinese market. In connection with WinHealth's investment in CET, Cumberland also made an additional $1.0 million investment in CET.
The Company’s ownership in CET is now 85% while the remaining interest is owned by WinHealth, Vanderbilt University and the Tennessee Technology Development Corporation. The operating results of CET allocated to noncontrolling interests in the consolidated statements of operations was income of $36,055 for the year ended December 31, 2024, and a loss of $51,446 for the year ended December 31, 2023.
Effective January 1, 2007, the Company formed a wholly-owned subsidiary, Cumberland Pharma Sales Corp. ("CPSC"). CPSC is the subsidiary that employs the Company's hospital, field and oncology sales force personnel.
In December 2017, the Company formed the Cumberland Pharma Foundation (the "Foundation") to serve as a vehicle to facilitate the ongoing philanthropic endeavors of Cumberland Pharmaceuticals Inc.
The Foundation was formed as a nonprofit corporation designed to qualify as a tax-exempt organization pursuant to Section 501(a) of the Internal Revenue Code. The Foundation’s Board of Directors is comprised of Cumberland Pharmaceuticals executives who are responsible for overseeing the Foundation’s ongoing activities including charitable contributions.
In 2018, Cumberland provided a grant of 50,000 shares of the Company’s common stock to the Foundation. The shares will address the ongoing financial needs of the Foundation. The organization also plans to hold a portion of the shares for long-term appreciation. The Foundation maintains separate financial statements and its ongoing operations do not impact the financial statements of Cumberland Pharmaceuticals. Initial annual grants by the Foundation have been and are expected to remain consistent with the historic level of contributions made by Cumberland Pharmaceuticals. Since 2019, Cumberland has made annual cash contributions to the Foundation except in the year 2024 where there was no contribution made. In 2023, the Company made a cash contribution of $40,000.
(2)Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements of the Company are stated in U.S. dollars and are prepared using U.S. generally accepted accounting principles. These financial statements include the accounts of the Company and its wholly and majority-owned subsidiaries. All significant intercompany transactions and accounts have been eliminated in consolidation.
Use of Estimates
The preparation of the consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management of the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates under different assumptions and conditions. The Company’s most significant estimates include: (1) its allowances for chargebacks and accruals for rebates and product returns, (2) the allowances for obsolescent or unmarketable inventory, (3) valuation of contingent consideration liability associated with business combinations and (4) evaluation of continuing utility of intangible assets.
Segment Reporting
The Company hasone operating segment which is specialty pharmaceutical products. Management has chosen to organize the Company based on the type of products sold. Operating segments are identified as components of an enterprise about which separate discrete financial information is evaluated by the chief operating decision maker, or decision-making group, in making decisions regarding resource allocation and assessing performance. The Company, which uses consolidated financial information in determining how to allocate resources and assess performance, evaluated that our specialty pharmaceutical products compete in similar economic markets and similar circumstances. Substantially all of the Company’s assets are located in the United States. Total revenues are primarily attributable to U.S. customers. Net revenues from customers outside the United States were approximately $2.7 million and $1.1 million for the years ended December 31, 2024 and 2023, respectively.
Fair Value of Financial Instruments
Fair value of financial assets and liabilities is the price the Company would receive to sell an asset or pay to transfer a liability in an orderly transaction with a market participant at the measurement date. The Company’s fair value measurements follow the appropriate rules as well as the fair value hierarchy that prioritizes the information used to develop the measurements. It applies whenever other guidance requires (or permits) assets or liabilities to be measured at fair value and gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements).
A summary of the fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels is described below:
Level 1 - Quoted prices for identical instruments in active markets.
Level 2 - Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable by correlation or other means.
Level 3 - Significant inputs to the valuation model are unobservable.
We maintain policies and procedures to value instruments using the best and most relevant data available. The following section describes the valuation methodologies we use to measure different financial instruments at fair value on a recurring basis.
The Company’s financial instruments include cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, contingent consideration liability and a revolving line of credit. The carrying values for cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate their fair values due to their short-term nature. The revolving line of credit has a variable interest rate, which approximates the current market rate.
The Company’s contingent consideration liability is a Level 3 fair value measurement that is updated on a recurring basis at each reporting period using a valuation model. Consistent with Level 3 fair value measurements, there are significant inputs to the valuation model that are unobservable.
Cash and Cash Equivalents
Cash and cash equivalents include highly liquid investments with original maturities of three months or less. As of December 31, 2024 and 2023, cash equivalents consist primarily of money market funds. The Company monitors concentration of credit risk with the financial institutions in which it conducts business. The Company has cash deposits which fluctuate in excess of federally insured limits throughout the year.
Accounts Receivable
Trade accounts receivable are recorded at the invoiced amount. The Company records allowances for amounts that could become uncollectible in the future based on historical experience, as well as amounts related to chargebacks and cash discounts. The Company reviews each customer balance to assess collection status.
The majority of the Company’s products are distributed through independent pharmaceutical wholesalers. The allowances against accounts receivable for chargebacks and discounts are determined on a product-by-product basis, and established by management as the Company’s best estimate at the time of sale based on each product’s historical experience adjusted to reflect known changes in the factors that impact such allowances. These allowances are established based on the contractual terms with direct and indirect customers and analyses of historical levels of chargebacks and discounts. The allowances in accounts receivable for chargebacks and cash discounts were $1.1 million and $0.6 million at December 31, 2024 and 2023, respectively.
Other organizations, such as managed care providers, pharmacy benefit management companies and government agencies, may receive rebates from the Company based on either negotiated contracts to carry the Company’s products or reimbursements for filled prescriptions. In conjunction with recognizing a sale to a wholesaler, revenues are reduced and accrued liabilities are increased by the Company’s estimate of the rebate that may be claimed. Cash discounts are reductions to invoiced amounts offered to customers for payment within a specified period of time from the date of the invoice.
Inventories
The Company works closely with third parties to manufacture and package finished goods for sale. Based on the customer relationship with the manufacturer or packager, the Company will either take title to finished goods at the time of shipment or at the time of arrival from the manufacturer. The Company then warehouses such goods until distribution and sale at third party facilities located in the U.S. and international locations. Periodic inventory counts are made by the warehouse teams and by the Company on a regular basis. In addition, the Company re-tests API inventory prior to use to confirm product expiration. Inventories are stated at the lower of cost or net realizable value with cost determined using the first-in, first-out method.
The Company continually evaluates inventories for potential losses due to expired, short-dated or slow-moving inventory by comparing sales history and sales projections to the inventory on hand. When evidence indicates the carrying value of a product may not be recoverable, a charge is recorded to reduce the inventory to its current net realizable value.
Non-current inventories consist of active pharmaceutical ingredients which typically have an extended life and selected finished good products with an extended life longer than one year.
Prepaid and Other Current Assets
Prepaid and other current assets consist of deferred offering costs, prepaid insurance premiums, prepaid consulting services, deposits and annual fees paid to the U.S. Food and Drug Administration ("FDA"). The Company expenses all prepaid and other current asset amounts as used or over the period of benefit primarily on a straight-line basis, as applicable.
In November 2017, the Company filed its Shelf Registration on Form S-3 with the SEC associated with the sale of up to $100 million in corporate securities. The Shelf Registration was declared effective in January 2018. It also included an At the Market ("ATM") feature that allows the Company to sell common shares at market prices. The Company filed an updated Form S-3 with the SEC in December 2020 (the “Prior Registration Statement”), which was declared effective in January 2021.
The Company filed an updated Form S-3 with the SEC on December 14, 2023, which was declared effective on December 26, 2023 (the “Current Registration Statement”). The Company entered into an agreement with H.C. Wainwright & Co., LLC (“H.C. Wainwright”) to establish a new ATM program under the Current Registration Statement. On March 20, 2024, the Company filed a related prospectus supplement in connection with the sale and issuance of shares having an aggregate gross sales price of up to $5.8 million.
The Company has recorded deferred offering costs for payments directly related to the current Shelf Registration on Form S-3 that was completed during December 2021 and December 2023. These costs consist of legal and accounting fees that the Company has capitalized. Deferred costs associated with the Shelf Registration will be reclassified to additional paid in capital on a pro-rata basis as the Company completes sales of shares under the Shelf Registration. The Company did not issue any shares under this ATM during the year ended December 31, 2024.
On February 5, 2025, the Company utilized the Sales Agreement with H. C. Wainwright and sold 1,000,000 shares of Cumberland’s common shares. These shares sold at a volume weighted average price of $5.4688 per share for aggregate gross proceeds of $5,468,800.
On February 14, 2025, the Company increased the maximum aggregate offering amount of the shares of the Company’s common stock issuable under the Sales Agreement with H.C. Wainwright for to up to $10 million and filed a prospectus supplement under the Sales Agreement for that aggregate offering amount.
Property and Equipment
Property and equipment, including leasehold improvements, are stated at cost. Depreciation is recognized using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the initial lease term plus renewal options, if reasonably assured, or the remaining useful life of the asset. Upon retirement or disposal of assets, any gain or loss is reflected as a component of operating loss in the consolidated statement of operations. Improvements that extend an asset’s useful life are capitalized. Repairs and maintenance costs are expensed as incurred.
Intangible Assets and Goodwill
The Company’s intangible assets and goodwill consist of capitalized costs related to product and license rights, patents, trademarks and goodwill obtained in the Vibativ and Sancuso acquisitions. Goodwill is not amortized for financial reporting purposes, but is subject to impairment analysis at least annually.
The cost of acquiring product and license rights are capitalized at fair value at the date of acquisition for products that are approved by the FDA for commercial use. These costs are amortized ratably over the estimated economic life of the product. The economic life is estimated based upon several factors. This includes the term of the license agreement, the patent life or market exclusivity of the product as well as management’s expectations of continued involvement with the product and the assessment of future sales, the future periods under which the product will be sold and the profitability of the product. This estimate is evaluated on a regular basis during the amortization period and adjusted if appropriate. If there are any changes made to the useful life of the product and license rights, the costs associated with such a change, if any, will be capitalized and amortized over the revised useful life.
Capitalized patent costs consist of outside legal costs associated with obtaining and protecting patents on products that have been approved for marketing by the FDA. If it becomes probable that a patent will not be issued or a patent has been declared invalid, related costs associated with the patent application are expensed at the time such determination is made. All costs associated with obtaining patents for products that have not been approved for marketing by the FDA are expensed as incurred.
Amortization expense is recognized ratably over the following periods:
| Product rights | Estimated economic life |
|---|---|
| License rights | Term of license agreement |
| Patents | Life of patent |
Trade and Note Receivables
Current Expected Credit Losses (“CECL”) is applicable to all financial assets measured at amortized cost. All financial instruments are evaluated, which principally relates to trade receivables and two notes receivable. CECL requires the measurement of expected credit losses on a collective (pool) basis when similar risk characteristics exist. This may include, either individually or in combination, some of the following characteristics of Accounting Standards Codification ("ASC") 326-20-55-5:
Internal or external credit score/rating
Risk ratings or classification
Financial asset type
Size
Effective interest rate
Term
Geographical location
Historical or expected credit loss patterns
Reasonable and supportable forecast periods
The standard requires entities to pool financial assets but allows them to choose which risk characteristics to use. Under the requirements of the guidance, the Company reassesses at the end of each reporting period whether the pool of assets continue to display similar risk characteristics.
With twenty years of experience, Cumberland has experienced virtually no write downs of receivables as most of our receivables are due from large successful pharmaceutical, healthcare or government customers, consistently making payments on account. Although the payment behaviors of all of our customers are consistently reliable, for the sake of transparency, we have separated our customer base into seven separate pools. The Company performs a monthly analysis of aged accounts receivable to determine how much, if any, of the accounts receivable balance should be reserved as potential bad debt. The Company reviews all balances over 90 days past due for a possible reserve and considers any specific factors or information for balances aged under 90 days if there are indicators that the balance should be reserved, such as other aged balances with the customer or bankruptcy as well as any economic issues with a customer, industry or region.
Impairment of Long-Lived Assets
Long-lived assets, such as property and equipment, operating lease right-of-use assets and intangible assets subject to depreciation and amortization, are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. If events or circumstances arise that require a long-lived asset to be tested for potential impairment, the Company first compares undiscounted cash flows expected to be generated by the asset to its carrying value. If the carrying amount of the long-lived asset is not recoverable on an undiscounted cash flow basis, an impairment charge is recognized to the extent that the carrying value exceeds the fair value. Fair value is determined through various valuation techniques including quoted market prices, third-party independent appraisals and discounted cash flow models.
Goodwill and other indefinite lived intangible assets that are not subject to amortization are tested at least annually for impairment. The impairment analysis for goodwill requires a comparison of fair value to the carrying value of the reporting unit. The Company’s goodwill was acquired in November 2018 with the Vibativ acquisition and in January 2022 with the Sancuso acquisition. As a result, the Vibativ and Sancuso components of the Company are the reporting units evaluated for goodwill impairment. Cumberland determined the fair value of the reporting units through current and future estimated revenue and profitability of the product. In 2023, given the delay in identifying a packager for Omeclamox-Pak, the Company took a non-cash write down of the related intangible assets of $3.3 million, which is included in amortization expense in the statement operations. Similarly in 2024, the Company recorded a non-cash write down of $0.4 million related to patent defense cost of our Acetadote product, which is also included in amortization expense in the statement of operations.
Revolving Line of Credit
The Company’s policy is to classify a debt obligation as current that otherwise meets the conditions of noncurrent classification when both of the following conditions are met:
The Company either a) has the ability and intent to repay the obligation within one year after the balance sheet date, or b) repays the obligation after the balance sheet date but before the financial statements are issued.
The repayment of the debt is made with assets that were classified as current as of the balance sheet date.
Joint Venture Agreement
In August 2020, Cumberland entered into an agreement with WinHealth Investment (Singapore) Ltd creating WHC Biopharmaceuticals, Pte. Ltd. The joint venture, as a limited liability company, focuses on acquiring, developing, registering, and commercializing development stage and commercial stage biopharmaceuticals for China, Hong Kong and other Asian markets. The agreement provided for initial investment from WinHealth in the form of a $0.2 million equity contribution and an initial investment from Cumberland in the form of $0.2 million convertible note. The joint venture will seek additional future capital from additional investors and has entered into exclusive option agreements to license intellectual property from both Cumberland Pharmaceuticals Inc. and Cumberland Emerging Technologies.
Net Product Revenue
Revenues from product sales are recognized in the amount that reflects the consideration that we expect to receive for these goods. Depending upon the shipping terms of the transaction, the revenue is recognized at the point where the customer obtains control of the goods and we satisfy our performance obligation. This occurs upon either shipment of the product or arrival at its ship to destination. Payment terms typically range from 30 to 60 days from date of shipment. The Company’s net product revenue reflects the reduction from gross product revenue for estimated allowances for chargebacks, discounts and damaged goods, and reflects sales related accruals for rebates, coupons, product returns, and certain administrative and service fees. Significant judgments must be made in determining the transaction price for our sales of products related to these adjustments.
During the year ended December 31, 2023, the Company revised its estimate for rebates related to Sancuso revenues based on additional information related to actual product activities. As a result, the Company recognized additional revenue allowances of $0.6 million for rebates as a change of estimate. There was no change in estimate for the year ended December 31, 2024.
Sales Rebates and Discounts
The allowances against accounts receivable and accrued liabilities for chargebacks, discounts, service fees and expired product returns are determined on a product-by-product basis, and established by management as the Company’s best estimate at the time of sale based on each product’s historical experience adjusted to reflect known changes in the factors that impact such allowances. These allowances are established based on the contractual terms with direct and indirect customers and analyses of historical levels of chargebacks, discounts and returns of expired product.
Other organizations, such as managed care providers, pharmacy benefit management companies and government agencies, may receive rebates from the Company based on either negotiated contracts to carry the Company’s products or reimbursements for filled prescriptions. In conjunction with recognizing a sale to a wholesaler, sales revenues are reduced and accrued liabilities are increased by the Company’s estimate of the rebate that may be claimed.
Sales Returns
Consistent with industry practice, the Company maintains a return policy that allows customers to return product within a specified period prior to and subsequent to the expiration date. The Company’s estimate of the provision for returns is based upon historical experience, expiration date by product as well as any other factor expected to impact future returns. Any changes in the assumptions used to estimate the provision for returns are recognized in the period those assumptions are changed.
Other Revenues
Other revenues primarily consist of income from grant funding programs, licensing agreements, leases and contract services. Revenue related to grants is recognized when all conditions related to such grants have been met. All other revenue is recognized when earned.
Cost of Products Sold
Cost of products sold consists principally of the cost to acquire each unit of product sold, including in-bound freight expense as well as any adjustment in the net realizable value of inventory acquired in acquisitions. Cost of products sold also includes expenses associated with the reduction in the net realizable value of slow-moving or expired product.
Selling and Marketing Expense
Selling and marketing expense consists primarily of expenses relating to the advertising, promotion, distribution and sale of products, including royalty expense, salaries and related costs.
Distribution Costs
Distribution costs are expensed as incurred and are included as a component of selling and marketing expenses in the consolidated statements of operations. Distribution costs were as follows for the years ended December 31:
| 2024 | 2023 | |
|---|---|---|
| Distribution costs | $863,529 | $881,829 |
Advertising Costs
Advertising costs are expensed as incurred and are included as a component of selling and marketing expenses in the consolidated statements of operations. Advertising costs were as follows for the years ended December 31:
| 2024 | 2023 | |
|---|---|---|
| Advertising costs | $2,987,575 | $2,903,741 |
Research and Development
Research and development costs are expensed in the period incurred. Research and development costs are comprised mainly of clinical trial and regulatory expenses, salaries, wages, fees paid to government regulators and other related costs such as materials and supplies. Research and development expense includes activities performed by third-party providers participating in the Company’s clinical studies. The Company accounts for these costs based on estimates of work performed, patients enrolled or fixed fees for services over the period of time the clinical trials are performed.
Income Taxes
The Company provides for deferred taxes using the asset and liability approach. Under this method, deferred tax assets and liabilities are recognized for future tax consequences attributable to operating loss and tax credit carryforwards, as well as differences between the carrying amounts of existing assets and liabilities and their respective tax bases. The Company’s principal differences are related to the timing of deductibility of certain items, such as inventory, depreciation, amortization and share-based compensation. Deferred tax assets and liabilities are measured using enacted statutory tax rates that are expected to apply to taxable income in the years such temporary differences are anticipated to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period of enactment. The Company only recognizes income tax benefits associated with an income tax position in which it is “more likely than not” that the position would be sustained upon examination by the taxing authorities.
In assessing the realizability of deferred tax assets, management considers whether some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of existing temporary differences, projected future taxable income and tax planning strategies in making this assessment.
The Company’s accounting policy with respect to interest and penalties arising from income tax settlements is to recognize them as part of the provision for income taxes.
Loss per Share
Basic loss per share is calculated by dividing net loss attributable to common shareholders by the weighted-average number of shares outstanding. Except where the result would be antidilutive, diluted loss per share is calculated by assuming the vesting of unvested restricted stock and the exercise of stock options and warrants and unrecognized compensation costs.
Share-Based Payments
The Company recognizes compensation cost for all share-based payments issued, modified, repurchased or canceled. Depending on the nature of the vesting provisions, restricted stock awards are measured using either the fair value on the grant date or the fair value of common stock on the date the vesting provisions lapse. Prior to the lapse for those equity grants not valued on the grant date, the fair value is measured on the last day of the reporting period.
Collaborative Agreements
The Company is a party to several collaborative arrangements with research institutions to identify and pursue promising pharmaceutical product candidates. The funding for these programs is primarily provided through Federal Small Business Administration (SBIR/STTR) and other grant awards. The Company has determined that these collaborative agreements, with the exception of the collaborative payment discussed in Note 3, related to the Vibativ and Sancuso contingent consideration payments, do not meet the criteria for accounting under ASC Topic 808, Collaborative Agreements. The agreements do not specifically designate each party’s rights and obligations to each other under the collaborative arrangements. Except for patent defense costs, expenses incurred by one party are not required to be reimbursed by the other party. Expenses incurred under these collaborative agreements are included in research and development expenses and funding received from grants are recorded as net revenues in the consolidated statements of operations.
Related Party Transactions
In July 2023, Cumberland named Martin S. Brown Jr. to our Board of Directors. Mr. Brown is an attorney with over 30 years of corporate law experience who brings significant legal, public company, health care and civic experience to our board. The Company relies on several law firms for legal advice, including the firm with which Mr. Brown is affiliated. In 2024 and 2023, the Company paid Mr. Brown’s law firm $0.05 million in each year.
Recent Accounting Guidance
Recent Accounting Pronouncements Adopted
In June 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2016-13, “Financial Instruments-Credit Losses,” which changes the impairment model for most financial assets and certain other instruments. For trade and other receivables, held-to-maturity debt securities, loans and other instruments, companies are required to use a new forward-looking “expected loss” model that generally results in an earlier recognition of allowances for losses. For available-for-sale debt securities with unrealized losses, companies measure credit losses in a manner similar with previous guidance, except that the losses are recognized as allowances rather than as reductions in the amortized cost of the securities. Companies have to disclose additional information, including information they use to track credit quality by year of origination for most financing receivables. Companies apply the ASU’s provisions as a cumulative-effect adjustment, if any, to the accumulated deficit as of the beginning of the first reporting period in which the guidance is adopted.
Related to ASU No. 2016-13 discussed above, in May 2019, the FASB issued ASU 2019-05, "Financial Instruments-Credit Losses (Topic 326): Targeted Transition Relief" which provides transition relief for ASU 2016-13 by providing entities with an alternative to irrevocably elect the fair value option for eligible financial assets measured at amortized cost upon adoption of the new credit losses standard. Certain eligibility requirements must be met and the election must be applied on an instrument-by-instrument basis. The election is not available for either available-for-sale or held-to-maturity debt securities. The Company adopted both ASU 2016-13 and ASU 2019-05 on January 1, 2023, and the adoption did not have a material impact on the Company’s consolidated financial statements.
In November 2023, the FASB issued final guidance in Update 2023-07, which is intended to improve transparency of segment disclosures, primarily through expanded disclosures for significant segment expenses. The guidance is effective for annual periods beginning in 2024 and interim periods beginning in 2025. With the Company having only one segment, the adoption, effective January 1, 2024, did not have a material impact on the Company’s consolidated financial statements.
Recently Issued Accounting Standards Not Yet Adopted
In December 2023, the FASB issued final guidance to improve transparency of income tax disclosures. The final guidance requires enhanced disclosures primarily related to existing rate reconciliation and income taxes paid information. The guidance is effective for 2025 annual reporting. Early adoption is permitted. This new guidance will result in incremental disclosures in the notes to the Company’s income tax disclosures.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses ("Update 2024-03"), which requires companies to disclose additional information for certain relevant expense categories in the Statements of Operations and within the notes to the financial statements. Update 2024-03 is effective for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted and can be applied either prospectively to financial statements issued for reporting periods after the effective date, or retrospectively to prior periods which are presented in the financial statements. We are currently assessing the impact of the requirements on our consolidated financial statements and disclosures.
(3)Vibativ®, Sancuso®and RediTrex®Products
Vibativ
During November 2018, the Company executed an agreement with Theravance Biopharma ("Theravance") to acquire the assets and global rights to Vibativ including responsibility for the marketing, distribution, manufacturing and regulatory activities associated with the brand. Vibativ is a patented, FDA approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.
Cumberland accounted for the transaction as a business combination in accordance with ASC 805 and the product sales are included in the results of operations subsequent to the acquisition date. The Company made an upfront payment of $20 million at the closing of the transaction and a $5 million milestone payment in early April 2019. In addition, Cumberland has agreed to pay royalties of up to 20% of on-going net sales of the product in the U.S. after a $2.5 million threshold is met. The future royalty payments were recognized at their acquisition-date fair value as a contingent consideration liability, as part of the contingent consideration transferred in the business combination. Cumberland prepared the valuations of the contingent consideration liability utilizing significant unobservable inputs. As a result, the valuation is classified as Level 3 fair value measurement.
The following table presents the changes in the fair value of the contingent consideration liability that is remeasured on a recurring basis. The contingent consideration earned and accrued in operating expenses is paid to Theravance annually.
| Contingent Consideration Liability | |
|---|---|
| Balance at December 31, 2022 | $4,154,823 |
| Cash payment of royalty during the period | (1,018,451) |
| Change in fair value | (270,485) |
| Contingent consideration earned and accrued | 1,167,486 |
| Balance at December 31, 2023 | $4,033,373 |
| Cash payment of royalty during the period | (817,387) |
| Change in fair value | (668,976) |
| Contingent consideration earned and accrued | 695,989 |
| Balance at December 31, 2024 | $3,242,999 |
The current portion of the contingent consideration liability is $1.1 million and the non-current portion is $2.1 million, as of December 31, 2024.
Sancuso
On January 3, 2022, Cumberland acquired the U.S. rights to the FDA-approved oncology-supportive care medicine Sancuso from Kyowa Kirin, Inc. ("Kyowa Kirin"), the U.S. affiliate of Japan-based Kyowa Kirin Co., Ltd.
Sancuso is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment. The active drug in Sancuso, granisetron, slowly dissolves in the thin layer of adhesive that sticks to the patient’s skin and is released into their bloodstream over several days, working continuously to prevent chemotherapy-induced nausea and vomiting (“CINV”). It is applied 24 to 48 hours before receiving chemotherapy and can prevent CINV for up to five consecutive days. Alternative oral treatments must be taken several times (day and night) to deliver the same therapeutic doses.
Cumberland acquired U.S. rights to Sancuso and assumed full commercial responsibility for the product in the U.S. – including its marketing, promotion, distribution, manufacturing and medical support activities. The product’s FDA registration was subsequently transferred from Kyowa Kirin to Cumberland in August 2023.
Cumberland has accounted for the transaction as a business combination in accordance with ASC 805 and the product sales are included in the results of operations subsequent to the acquisition date. The Company made an upfront payment of $13.5 million at the closing of the transaction. The Agreement calls for milestone payments of up to $3.5 million based on the attainment of various approvals and sales performance. In January 2023, Cumberland made a $1.0 million milestone payment to Kwoya Kirin based on the FDA approval of a manufacturing site for the product. In October 2023, Cumberland made a $0.5 million milestone payment based on the successful transfer of the product’s FDA registration from Kyowa Kirin to Cumberland.
The remaining $2 million in milestone payments are tied to achievement of certain annual sales levels for the product.
In addition, Cumberland has agreed to pay a royalty of up to 10% of on-going net sales of the product. The future royalty payments were required to be recognized at their acquisition-date fair value as a contingent consideration liability, as part of the contingent consideration transferred in the business combination. Cumberland has prepared a valuation of the contingent consideration liability utilizing significant unobservable inputs. As a result, the valuation is classified as Level 3 fair value measurement.
The acquisition was funded by cash and the Company's revolving credit facility. The fair value for the assets and liabilities assumed using Level 3 fair value inputs were as follows: prepaid expenses of $1.8 million, inventory $2.6 million, goodwill $0.03 million, intangible assets $14.1 million, milestone payable $1.7 million and contingent liability $3.4 million.
The following table presents the changes in the fair value of the contingent consideration liability that is remeasured on a recurring basis.
| Contingent Consideration Liability | |
|---|---|
| Balance at December 31, 2022 | $3,000,000 |
| Cash payment of royalty during the period | (790,632) |
| Change in fair value | (685,355) |
| Contingent consideration earned and accrued | 781,987 |
| Balance at December 31, 2023 | $2,306,000 |
| Cash payment of royalty during the period | (898,686) |
| Change in fair value | (791,828) |
| Contingent consideration earned and accrued | 900,514 |
| Balance at December 31, 2024 | $1,516,000 |
The current portion of the contingent consideration liability is $0.8 million and the non-current portion is $0.7 million, as of December 31, 2024.
RediTrex
In November 2016, the Company announced an agreement with the Nordic Group B.V. ("Nordic") to acquire the exclusive U.S. rights to Nordic’s injectable methotrexate product line designed for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis, severe psoriatic arthritis, and severe disabling psoriasis.
As consideration for the license Cumberland paid a deposit of $0.1 million at closing. The Company provided $0.9 million in consideration through a grant of 180,000 restricted shares of Cumberland common stock to be vested upon the FDA approval of the first Nordic product. Cumberland also agreed to provide Nordic a series of payments tied to the products’ FDA approval, launch and achievement of certain sales milestones. Under the terms of the agreement, Cumberland is responsible for the product registration and commercialization in the U.S. Nordic is responsible for product manufacturing and supply.
On November 27, 2019, Cumberland received FDA approval for the first Nordic injectable product and authorization to market them under the RediTrex brand name. The 180,000 shares of restricted Cumberland common stock previously provided to Nordic vested upon approval and were valued at $0.9 million on the vesting date. The FDA approval also resulted in a $1.0 million milestone payment due to Nordic. This milestone payment was paid in July 2020. During December 2020, Cumberland began distributing RediTrex which also resulted in a $1.0 million milestone payment due to Nordic. The full launch of RediTrex occurred in October 2021.
Effective July 12, 2022, the Company entered into an amendment to our agreement with Nordic whereby they may assume responsibility for RediTrex marketing authorization in the U.S. and the opportunity to commercialize the product in the U.S. after June 30, 2023. In accordance with the terms of the amendment, Nordic a) returned the 180,000 restricted Cumberland shares we previously issued to Nordic which were cancelled; b) refunded to Cumberland the milestone payment of $1.0 million we made associated with the brand’s U.S. approval; and c) issued a credit note in favor of the Company in the amount of $1.0 million for the unpaid milestone payment due from us for launch of the product line all in 2023. Cumberland will receive a long-term royalty on any Nordic sales of the product.
(4)Revenues
Product Revenue
The Company’s net product revenues consisted of the following for the years ended December 31:
| 2024 | 2023 | |
|---|---|---|
| Products: | ||
| Kristalose | $15,315,259 | $15,981,850 |
| Sancuso | 9,005,129 | 8,096,788 |
| Vibativ | 7,160,125 | 8,812,692 |
| Caldolor | 4,959,385 | 4,333,923 |
| Acetadote | 185,182 | 458,759 |
| Omeclamox | (3,075) | 20,030 |
| Vaprisol | (174,538) | 151,336 |
| RediTrex | 90,237 | (341,886) |
| Total net product revenues | $36,537,704 | $37,513,492 |
Other Revenues
The Company has agreements with international partners for commercialization of the Company’s products with associated payments included in other revenues. Those agreements provide that each of the partners is responsible for seeking regulatory approvals for the product, and following approval, each partner will be responsible for the ongoing distribution and sales in the respective international territories. The Company provides a dossier for product registration and maintains responsibility for the relevant intellectual property. Cumberland is typically entitled to receive a non-refundable, up-front payment at the time each agreement is executed as consideration for the product dossier and for the rights to the distinct intellectual property rights in the respective international territory. These agreements also typically provide for additional payments upon a partner’s achievement of a defined regulatory approval and sales milestones. The Company may also be entitled to receive royalties on future sales of the products and a transfer price on supplies. The contractual payments associated with the partner’s achievement of regulatory approvals, sales milestones and royalties on future sales are recognized as revenue upon occurrence, or at such time that the Company has a high degree of confidence that the revenue would not be reversed in a subsequent period.
In the second quarter of 2023, the Company received $1 million relating to a litigation settlement based ontwo $500,000 milestone payments due to us for the license associated with our Vibativ product that is included in other revenue for the year ended December 31, 2023.
Other revenues includes funding from federal grant programs including those secured from the FDA and from those secured by CET through the Small Business Administration. Grant revenue from these federal grant programs totaled approximately $0.4 million for the years ended December 31, 2024 and 2023.
Other revenues also includes lease income generated by CET’s Life Sciences Center. It is a research facility that provides scientists with access to flexible lab space and other resources to develop biomedical products. This lease income, as noted in Footnote 15 - Leases, was approximately $0.6 million and $0.5 million and for the years ended December 31, 2024 and 2023, respectively.
(5)Inventories, Net
The Company's net inventories consisted of the following as of December 31:
| 2024 | 2023 | |
|---|---|---|
| Raw materials | $11,982,045 | $12,619,092 |
| Consigned inventory | 126,090 | 149,701 |
| Finished goods, net of reserve | 2,897,359 | 4,645,098 |
| Total inventories | 15,005,494 | 17,413,891 |
| less non-current inventories | (11,005,499) | (12,804,529) |
| Total inventories classified as current | $3,999,995 | $4,609,362 |
The Company's non-current inventories consisted of the following as of December 31:
| 2024 | 2023 | |
|---|---|---|
| Vibativ Raw Materials | $6,180,347 | $6,611,426 |
| Vibativ Finished Goods | 183,057 | 810,454 |
| Kristalose Raw Materials | 2,672,720 | 3,263,515 |
| Vaprisol Raw Materials | 1,172,849 | 1,170,641 |
| Caldolor Finished Goods | 77,382 | 67,307 |
| Sancuso Raw Materials | 458,684 | 574,502 |
| Acetadote Raw Materials | 23,915 | — |
| Omeclamox | 69,622 | — |
| Study Drug Raw Materials | 166,923 | 203,383 |
| Other Products | — | 103,300 |
| Total non-current inventory | $11,005,499 | $12,804,529 |
The Company purchases the active pharmaceutical ingredient (“API”) for Kristalose and maintains the inventory of that raw material. API for the Company's Vaprisol and Vibativ brands were included in the assets associated with the acquisition of those brands and are also included in the raw materials inventory. As part of the Vibativ acquisition, the Company acquired API and work in process inventories of $15.6 million that were all initially classified as non-current inventories at the date of acquisition. Consigned inventory represents Authorized Generic inventory stored with Padagis until shipment.
At December 31, 2024 and 2023, there wereno cumulative obsolescence or discontinuance losses necessary to recognize.
(6)Property and Equipment
Property and equipment consisted of the following at December 31:
| Range ofuseful lives | 2024 | 2023 | |
|---|---|---|---|
| Computer equipment | 3 – 5 years | $514,174 | $499,557 |
| Office equipment | 3 – 15 years | 792,903 | 771,667 |
| Furniture and fixtures | 5 – 15 years | 537,057 | 533,778 |
| Leasehold improvements | 3 – 15 years, or remaining lease term | 825,074 | 800,974 |
| Total property and equipment, gross | 2,669,208 | 2,605,976 | |
| Less: accumulated depreciation and amortization | (2,391,843) | (2,238,073) | |
| Total property and equipment, net | $277,365 | $367,903 |
Depreciation expense, including amortization expense related to leasehold improvements, is included in general and administrative expense in the consolidated statements of operations. Depreciation expense was as follows for the years ended December 31:
| 2024 | 2023 | |
|---|---|---|
| Depreciation expense | $154,308 | $177,148 |
(7)Intangible Assets and Goodwill
Intangible assets and Goodwill consisted of the following at December 31, 2024 and 2023.
| 2024 | 2023 | |
|---|---|---|
| Product and license rights | $43,250,341 | $43,250,341 |
| Less: accumulated amortization | (26,300,793) | (22,755,543) |
| Total product and license rights | 16,949,548 | 20,494,798 |
| Patents | 10,808,476 | 10,712,405 |
| Less: accumulated amortization | (9,965,779) | (8,819,287) |
| Total patents | 842,697 | 1,893,118 |
| Trademarks | 433,397 | 413,775 |
| Less: accumulated amortization | (252,193) | (193,773) |
| Total trademarks | 181,204 | 220,002 |
| Total intangible assets | $17,973,449 | $22,607,918 |
| Goodwill | $914,000 | $914,000 |
Product and license rights include assets associated with the Company’s acquired products, including those discussed in Note 3, Vibativ and Sancuso.
During 2024 and 2023, the Company recorded an additional $0.1 million for each year in intangible assets for patents, trademarks and capitalized patent costs, including amounts incurred in the protection of the Company's intellectual property.
Amortization expense related to product and license rights, trademarks and patents were as follows for the years ended December 31:
| 2024 | 2023 | |
|---|---|---|
| Amortization and impairment expense | $4,748,252 | $8,102,648 |
The expected amortization expense for the Company's current balance of intangible assets are as follows:
| Year ending December 31: | |
|---|---|
| 2025 | $3,991,482 |
| 2026 | 3,776,803 |
| 2027 | 3,421,395 |
| 2028 | 2,535,409 |
| 2029 and thereafter | 4,248,360 |
| $17,973,449 | |
(8)Other Current and Other Long-term Liabilities
Other current liabilities consisted of the following at December 31:
| 2024 | 2023 | |
|---|---|---|
| Rebates, product returns, administrative and service fees | $7,834,210 | $7,579,783 |
| Employee wages and benefits | 1,200,790 | 1,197,832 |
| Current portion of accrued contingent consideration | 1,370,556 | 2,424,000 |
| Studies accrual | 429,825 | 385,266 |
| Sancuso related liabilities | 289,928 | 827,813 |
| Accrued audit fees | 273,000 | — |
| Current deferred charges | 207,059 | 220,402 |
| Other | 645,587 | 961,432 |
| Total accrued liabilities | $12,250,955 | $13,596,528 |
Other long-term liabilities consisted of the following at December 31:
| 2024 | 2023 | |
|---|---|---|
| Non-current portion of accrued contingent consideration | $2,877,312 | $3,284,672 |
| Deferred compensation | 3,172,483 | 2,894,894 |
| Other | 250,000 | 274,000 |
| Total other long-term liabilities | $6,299,795 | $6,453,566 |
(9)Debt
On September 5, 2023, the Company entered into a new Revolving Credit Loan Agreement with Pinnacle Bank. This facility provides for an aggregate principal funding amount of up to $25 million. The initial revolving line of credit is up to $20 million, with the ability for Cumberland to increase the amount to $25 million, under certain conditions. It has athree year term expiring on October 1, 2026. The interest rate is based on a benchmark (Term SOFR) plus a spread of 2.75%. Cumberland is subject to one financial covenant, the maintenance of a Funded Debt Ratio, determined on a quarterly basis. Borrowings under the line of credit are collateralized by substantially all of our assets.
On May 6, 2024, the Company entered into a First Amendment to the Loan Agreement which provides an alternative to the financial covenant by delivering to the lender a borrowing base certificate and complying with certain borrowing base requirements which set forth a maximum revolver amount equal to the lessor of (a) up to $20 million or (b) the sum of the Company's cash balances and eligible accounts receivable.
As of December 31, 2024 and December 31, 2023, the Company had $15.3 million and $12.8 million, respectively, in borrowings outstanding under its revolving credit facility. The applicable interest rate under the Pinnacle Agreement was 7.25% and 8.125% at December 31, 2024 and December 31, 2023, respectively.
(10)Shareholders’ Equity
(a) Initial Public Offering
On August 10, 2009, the Company completed its initial public offering of 5,000,000 shares of common stock at a price of $17.00 per share, raising gross proceeds of $85.0 million. After deducting underwriting discounts of approximately $6.0 million and offering costs incurred of approximately $4.2 million, the net proceeds to the Company were approximately $74.8 million.
(b) Preferred Stock
The Company is authorized to issue 20,000,000 shares of preferred stock. The Board of Directors is authorized to divide these shares into classes or series, and to fix and determine the relative rights, preferences, qualifications and limitations of the shares of any class or series so established. At December 31, 2024 and 2023, there wasno preferred stock outstanding.
(c) Common Stock
During 2024 and 2023, the Company issued 169,991 shares and 157,360 shares of common stock, respectively, as a result of restricted shares vesting as well as other common share issuances. There were no option exercise transactions during 2024 and 2023.
(d) Share Repurchases
The Company currently has a share repurchase program available to repurchase up to $10 million of its common stock pursuant to Rule 10b-18 of the Securities Exchange Act of 1934. The Company repurchased 339,200 shares and 402,143 shares of common stock for approximately $0.6 million and $0.7 million during the years ended December 31, 2024 and 2023, respectively. There remains approximately $2.4 million available under the current repurchase program available for share repurchases at December 31, 2024.
(11)Loss Per Share
The following table shows the computation of the numerator and the denominator used to calculate diluted loss per share for the years ended December 31:
| 2024 | 2023 | |
|---|---|---|
| Numerator: | ||
| Net loss | $(6,443,715) | $(6,330,766) |
| Net (income) loss at subsidiary attributable to noncontrolling interests | (36,055) | 51,446 |
| Net loss attributable to common shareholders | $(6,479,770) | $(6,279,320) |
| Denominator: | ||
| Weighted-average shares outstanding – basic | 14,060,272 | 14,298,774 |
| Weighted-average shares outstanding – diluted | 14,060,272 | 14,298,774 |
The Company's anti-dilutive restricted shares and stock options outstanding were as follows for the years ended December 31:
| 2024 | 2023 | |
|---|---|---|
| Anti-dilutive shares and options | 611,353 | 452,224 |
(12)Income Taxes
The components of the Company's net deferred tax assets at December 31 are as follows:
| 2024 | 2023 | |
|---|---|---|
| Deferred Tax Assets | ||
| Net operating loss and tax credits | $14,312,099 | $15,427,801 |
| Property and equipment and intangibles | 79,979 | 71,990 |
| Right-of-use liability | 1,205,692 | 1,307,178 |
| Intangible assets | 2,762,590 | 2,337,091 |
| Section 174 expenses | 2,586,832 | 2,208,093 |
| Allowance for accounts receivable | 306,007 | 147,919 |
| Reserve for expired product | 649,549 | 616,979 |
| Inventory | 266,695 | 185,189 |
| Business interest expense limitation | 54,720 | — |
| Deferred charges | 1,027,520 | 937,935 |
| Cumulative compensation costs incurred on deductible equity awards | 83,189 | 176,926 |
| Total deferred tax assets | 23,334,872 | 23,417,101 |
| Deferred Tax Liabilities | ||
| Right-of-use asset | (1,385,534) | (1,547,773) |
| Net deferred tax assets, before valuation allowance | 21,949,338 | 21,869,328 |
| Less: deferred tax asset valuation allowance | (21,949,338) | (21,869,328) |
| Net deferred taxes | $— | $— |
The following table summarizes the amount and year of expiration of the Company's federal and state net operating loss carryforwards as of December 31, 2024:
| Years of expiration | Federal | State |
|---|---|---|
| 2025 | $— | $213,534 |
| 2026-2042 | 45,526,439 | 26,275,020 |
| Indefinite Period | 7,143,930 | 3,299,837 |
| Total federal and state net operating loss carryforwards | $52,670,369 | $29,788,391 |
Income tax expense (benefit) includes the following components for the years ended December 31:
| 2024 | 2023 | |
|---|---|---|
| Current: | ||
| Federal | $— | $— |
| State and other | (22,669) | 45,769 |
| Total current income tax expense | (22,669) | 45,769 |
| Deferred: | ||
| Federal | — | — |
| State | — | — |
| Total deferred income tax expense | — | — |
| Total income tax expense (benefit) | $(22,669) | $45,769 |
The Company’s effective income tax rate for 2024 and 2023 reconciles with the federal statutory tax rate as follows:
| 2024 | 2023 | |
|---|---|---|
| Income tax expense computed at federal statutory tax rate | 21.00% | 21.00% |
| State Taxes Net of Federal Benefit | 0.11 | (0.58) |
| Tax Credits Generated | 3.31 | 0.80 |
| Change in valuation allowance | (23.61) | (4.96) |
| Permanent differences | (1.86) | (6.51) |
| Expiring tax credits | (0.28) | (3.32) |
| Deferred True-ups | 1.67 | (7.16) |
| Net loss tax benefit (expense) | 0.34% | (0.73)% |
The Company believes that it is not more likely than not that its net deferred tax assets will be realized. As such, the net deferred tax assets are fully offset with a valuation allowance as of the periods ended December 31, 2024 and 2023.
As of December 31, 2024, the Company has general business credit carryforwards of $1.5 million. These credit carryforwards will expire in years 2025 through 2044.
| Years of expiration | Federal |
|---|---|
| 2025 | $25,323 |
| 2026-2044 | 1,518,577 |
| Total federal and state credit carryforwards | $1,543,900 |
The Company expects it will continue to pay minimal taxes in future periods through the continued utilization of net operating loss carryforwards, as it is able to achieve taxable income through its operations. The Company is no longer subject to U.S. federal tax examinations for tax years before 2021, and with few exceptions, the Company is not subject to examination by state tax authorities for tax years which ended before 2021. Loss carryforwards and credit carryforwards generated or utilized in years earlier than 2021 remain subject to examination and adjustment. During 2012, the 2009 federal tax return was examined by the Internal Revenue Service with no significant findings or adjustments. During 2024, the 2022 federal tax return was selected for examination by the Internal Revenue Service. Based on the audit plan, the estimated completion date of this exam is July 31, 2025. The Company has no unrecognized tax benefits in 2024 and 2023.
(13)Stock-Based Compensation Plans
The Company has grants outstanding undertwo equity compensation plans. The 2007 Long-Term Incentive Compensation Plan (the "2007 Plan") and the 2007 Directors’ Incentive Plan (the "Directors’ Plan"), which were approved by shareholders, superseded the 1999 Stock Option Plan. Both plans are available for future grants of equity compensation awards to employees, consultants and directors. The 2007 Plan and the Directors’ Plan provide for the issuance of stock options, stock appreciation rights and restricted stock. Vesting is determined on a grant-by-grant basis in accordance with the terms of the plans and the related grant agreements. The Company has reserved 3.2 million shares of common stock for issuance under the 2007 Plan and 250,000 shares for issuance under the Directors’ Plan. As of December 31, 2024, the Company had 784,604 shares available for future grants under the 2007 Plan and 114,007 shares available under the Directors’ Plan.
The exercise price of stock options is generally 100% of the fair market value of the underlying common stock on the grant date, except for incentive stock options granted to 10% shareholders, which the exercise price is no less than 110% of the fair market value. The maximum contractual term of stock options isten years from the grant date, except for incentive stock options granted to 10% shareholders, which is no more than five years.
During 2011, the Company began issuing shares of restricted stock with no exercise price to employees and directors. Restricted stock issued to employees generally cliff-vests on the fourth anniversary of the grant date. Beginning in 2021, the Company began issuing incentive stock options to employees with the same fourth anniversary cliff-vest. Restricted stock continues to be issued to directors and vests on theone year anniversary of the grant date. Restricted stock issued to advisors generally cliff-vests on the fourth anniversary of the grant date.
Stock compensation expense is presented as a component of general and administrative expense in the consolidated statements of operations. Stock compensation expense was $0.3 million and $0.4 million for the years ended December 31, 2024 and 2023, respectively.
At December 31, 2024, there was approximately $0.4 million of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted-average period of 1.76 years.
Stock Options
Stock options activity was as follows:
| Numberof option shares | Weighted-averageexercise price | Weighted-average remaining contractual term | |
|---|---|---|---|
| Outstanding, December 31, 2022 | 319,650 | $3.00 | 6.15 |
| Granted | 192,750 | 2.06 | |
| Exercised | — | — | |
| Forfeited/canceled | (25,150) | 2.55 | |
| Outstanding, December 31, 2023 | 487,250 | 2.65 | 5.59 |
| Granted | 190,450 | 1.80 | |
| Exercised | — | — | |
| Forfeited/canceled | (36,100) | 2.25 | |
| Outstanding, December 31, 2024 | 641,600 | $2.42 | 5.00 |
The weighted-average grant-date fair value of options granted during the years 2024 and 2023 was $1.05 and $1.16 , respectively. No options were vested and exercisable at December 31, 2024. The aggregate intrinsic value of options outstanding was minimal.
The fair value of stock options is calculated using the Black-Scholes (“Black-Scholes-Merton”, or “BSM”) option-pricing model on the grant date. Since 2012, the Company had been issuing Restricted Share Awards where the grant date Fair Value (“FV”) equaled the closing share price. The assumptions used in the Black-Scholes valuation to determine the FV of stock options were as follows at December 31:
| 2024 | 2023 | |
|---|---|---|
| Expected term (in years) | 5.69 | 5.71 |
| Expected volatility | 67.89% | 65.87% |
| Risk free interest rate | 4.24% | 3.45% |
| Expected dividend yield | — | — |
Expected Term - The Company has estimated the expected life of its stock options using the simplified method, whereby the expected life equals the average of the vesting term and the original contractual term of the option.
Expected volatility -Based on the Company’s historical stock price volatility.
Risk Free rate - The Company bases the risk-free interest rate assumption for equity awards on the rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued.
Expected dividend yield - The Company’s expected dividend yield assumption iszero as it has never paid dividends and has no present intention to do so in the future.
Restricted Stock Awards
Restricted stock activity was as follows:
| Number of shares | Weighted-average grant-datefair value | |
|---|---|---|
| Nonvested, December 31, 2022 | 395,751 | 4.29 |
| Granted | 34,250 | 1.93 |
| Vested/released | (157,360) | 5.73 |
| Forfeited/canceled | (12,075) | 3.63 |
| Nonvested, December 31, 2023 | 260,566 | 3.14 |
| Granted | 50,500 | 1.71 |
| Vested/released | (169,991) | 3.37 |
| Forfeited/canceled | (1,250) | 3.56 |
| Nonvested, December 31, 2024 | 139,825 | 2.34 |
The fair value of restricted stock granted was based on the closing market price of the Company’s common stock on the grant date. The fair value of restricted stock awards that vested during the years 2024 and 2023 was $0.3 million for each year. At December 31, 2024, there was approximately $0.1 million of unrecognized compensation costs related to restricted stock awards, which is expected to be recognized over a weighted-average period of less than a year. The restricted stock grants are included in the diluted weighted shares outstanding computation until they cliff-vest. Once vested they are included in the basic weighted shares outstanding computation.
(14)Employee Benefit Plans
The Company sponsors an employee benefit plan that was established on January 1, 2006, the Cumberland Pharmaceuticals 401(k) Plan (the "Plan"), under Section 401(k) of the Internal Revenue Code of 1986, as amended, for the benefit of all employees over the age of 21, having been employed by the Company for at leastsix months. The Plan provides that participants may contribute up to the maximum amount of their compensation as set forth by the Internal Revenue Service each year. Employee contributions are invested in various investment funds based upon elections made by the employees. During 2024 and 2023, the Company contributed approximately $0.08 million in each year to the Plan as an employer match of participant contributions.
In 2012 and 2013, the Company established non-qualified unfunded deferred compensation plans that allow participants to defer receipt of a portion of their compensation. The liability under the plans, reflected in other long term liabilities in the consolidated balance sheets, was $3.2 million and $2.9 million as of December 31, 2024 and 2023, respectively. The Company had assets consisting of company-owned life insurance contracts generally designated to pay benefits of the deferred compensation plans reflected in other assets in the consolidated balance sheet of $2.3 million and $2.4 million as of December 31, 2024 and 2023, respectively.
(15)Leases
On November 15, 2021, Cumberland entered into a lease, pursuant to which the Company leases approximately 16,903 rentable square feet of space at the new development Broadwest located in Nashville, Tennessee with 1600 West End Avenue Partners, LLC. The leased premise serves as the Company's new corporate headquarters. The initial term of the lease is one hundred fifty-seven (157) months, withtwo consecutive options to renew for a period offive years each, with the commencement date of October 25, 2022. This lease currently expires in November 2035.
The Company is responsible for paying rent to the Landlord under the lease beginning three months after the commencement date. The Company pays a base rent of $33.06 per square foot of rentable space with a gradual rental rate increase of 2.5% for each year period thereafter of the prior year's base rental. In addition to the monthly base rent, the Company is responsible for its percentage share of the operating expenses of the building. The lease also provides for a tenant improvement allowance for the space.
On October 24, 2022, the CET lease with The Gateway to Nashville, LLC provided the notice of exercise to extend the lease forfive years. The lease is for approximately 14,200 square feet of wet laboratory and office space in Nashville, Tennessee where CET operates the CET Life Sciences Center.The wet laboratory and office space is leased through April 2028. The Company also subleases a portion of the space under this lease.
Included within the right-of-use assets are startup expenditures related to a new supply agreement with Nephron Pharmaceuticals Corporation (“Nephron”). These expenditures are classified as an embedded lease resulting in a right-of-use asset to be amortized over the life of the Nephron contract. As of December 31, 2024 and 2023, the value of this asset was $0.8 million and $1.0 million, respectively.
Also included within the right-of-use assets are startup expenditures related to a new master services agreement and project agreement with Kindos Pharmaceuticals Co. Ltd. signed in 2024. These expenditures are also classified as an embedded lease resulting in a right-of-use asset to be amortized over the life of the Kindos contract. As of December 31, 2024, the value of the asset was $0.1 million.
Rent expense is recognized over the expected term of the lease on a straight-line basis as a component of general and administrative expense. Rent expense and sublease income were as follows for the years ended December 31:
| 2024 | 2023 | |
|---|---|---|
| Rent expense | $1,384,083 | $1,304,865 |
| Sublease income | $554,069 | $544,138 |
In March 2016, the FASB issued ASU 2016-02. ASU 2016-02’s core principle is to increase transparency and comparability among organizations by recognizing lease assets and liabilities on the balance sheet and disclosing key information. The primary effect of adopting ASU 2016-02 to the Company was to record right-of-use assets and obligations for the leases currently classified as operating leases.
Operating lease liabilities were recorded as the present value of remaining lease payments not yet paid for the lease term discounted using the incremental borrowing rate associated with each lease. Operating lease right-of-use assets represent operating lease liabilities adjusted for lease incentives and initial direct costs. As the Company’s leases do not contain implicit borrowing rates, the incremental borrowing rates were calculated based on information available at October 25, 2022 and May 1, 2023. Incremental borrowing rates reflect the Company’s estimated interest rates for collateralized borrowings over similar lease terms.
The weighted-average remaining lease term for the Broadwest and Gateway leases is 9.60 years and 10.42 years for the year ended December 31, 2024 and 2023, respectively. The weighted-average incremental borrowing rate used to discount the present value of the remaining lease payments of both leases is 9.38% and 9.40% for the years ended December 31, 2024 and 2023, respectively.
Lease Position
At December 31, 2024 and 2023, the Company recorded the following on the Consolidated Balance Sheet:
| Right-of-Use Assets | December 31, 2024 | December 31, 2023 |
|---|---|---|
| Operating lease right-of-use assets | $6,176,923 | $6,674,394 |
| Lease Liabilities | December 31, 2024 | December 31, 2023 |
|---|---|---|
| Operating lease current liabilities | $356,508 | $348,092 |
| Operating lease non-current liabilities | 4,939,739 | 5,296,247 |
| Total | $5,296,247 | $5,644,339 |
As of December 31, 2024, cumulative future minimum sublease income under non-cancelable operating subleases totals approximately $0.2 million which includes the 90-day notice required for lease termination. Future minimum lease payments under non-cancelable operating leases (with initial or remaining lease terms in excess of one year) are as follows:
| Maturity of Leases Liabilities at December 31, 2024 | Operating Leases |
|---|---|
| 2025 | $836,100 |
| 2026 | 909,911 |
| 2027 | 934,180 |
| 2028 | 740,791 |
| 2029 | 650,766 |
| After 2029 | 4,196,635 |
| Total minimum lease payments | 8,268,383 |
| Less: Interest | (2,972,136) |
| Present value of lease liabilities | $5,296,247 |
(16)Market Concentrations
The Company’s principal financial instruments subject to potential concentration of credit risk are accounts receivable, which are unsecured, and cash equivalents. The Company’s cash equivalents consist primarily of money market funds. Certain bank deposits may be in excess of the insurance limits provided by the Federal Deposit Insurance Corporation.
The Company’s primary customers are wholesale pharmaceutical distributors in the U.S. Total revenues by customer for each customer representing 10% or more of consolidated revenues are summarized below for the years ended December 31:
| 2024 | 2023 | |
|---|---|---|
| Customer 1 | 29% | 29% |
| Customer 2 | 26% | 26% |
| Customer 3 | 21% | 24% |
The Company’s accounts receivable, net of allowances, due from the customers representing 10% or more of consolidated revenue was 63.7% and 62.3% at December 31, 2024 and 2023, respectively.
(17)Manufacturing and Supply Agreements
The Company utilizesone ortwo primary suppliers to manufacture each of its products and product candidates. Although there are a limited number of manufacturers of pharmaceutical products, the Company believes it could utilize other suppliers to manufacture its prescription products on comparable terms. A change in suppliers, problems with its third-party manufacturing operations or related production capacity, or contract disputes with suppliers could cause a delay in manufacturing or shipment of finished goods and possible loss of sales, which could adversely affect operating results.
(18)Employment Agreements
The Company has entered into employment agreements with all its full-time employees. Each employment agreement provides for a salary for services performed, a potential annual bonus and, if applicable, a grant of restricted common shares pursuant to a restricted stock and incentive stock option agreement.
(19)Commitments and Contingencies
Commitments
In connection with its licensing agreements for Caldolor, the Company is required to pay royalties based on net sales over the life of the product. Royalty expense is recognized as a component of selling and marketing expense in the period that revenue is recognized.
In connection with the acquisition of Vibativ, the Company is required to pay royalties based on net sales of the product. At the purchase date, Cumberland recorded the fair value of this liability and will continue to evaluate the liability each period and the royalty expense is recognized as a component of selling and marketing expense in the period that the change in fair value is recognized.
In connection with the acquisition of Sancuso, the Company is required to pay up to $3.5 million in milestones and tiered royalties ranging from 10% to 5% on U.S. net product sales forten years.
Legal Matters
Cumberland has a number of patents issued through the United States Patent and Trademark Office (the “USPTO”) including U.S. Patent number 8,148,356 (the “356 Acetadote Patent”) which is assigned to the Company. The claims of the 356 Acetadote Patent encompass the new Acetadote formulation and include composition of matter claims. Following its issuance, the 356 Acetadote Patent was listed in the FDA Orange Book. The 356 Acetadote Patent is scheduled to expire in May 2026, which time period includes a 270-day patent term adjustment granted by the USPTO.
Since 2012, Cumberland has continued to vigorously defend and protect its Acetadote product and related intellectual property rights including the use of all its legal options.
Melinta Litigation
On February 2, 2022, the Company filed an action for breach of contract against Melinta Therapeutics, LLC and Targanta Therapeutics Corporation (collectively, the “Defendants”) in the United States District Court for the Southern District of New York (Case No. 1:22-cv-00915-VM). The Company and the Defendants are parties to an agreement (the “Agreement”), pursuant to which the Defendants have a license to develop and commercialize products under certain Company patents, in exchange for the Defendants paying the Company certain milestone payments and royalties on net sales of the licensed products.
Specifically, the Agreement requires the Defendants to, among other things, make a $500,000 payment to the Company within 30 days following the first filing of an sNDA in relation to the Product (as defined by the Agreement) and a $500,000 payment to the Company following the approval of the first sNDA in relation to the Product.
After Defendants disclosed the domiciles of its limited partners to the Company, as required by the Court, on October 24, 2022, the action for breach of contract was refiled in the Supreme Court of the State of New York, County of New York (Index No. 654234/2022) on November 7, 2022.
The complaint alleges that, despite the Defendants filing an NDA and sNDA for the Product and receiving FDA approval for both applications, the Defendants failed to make the required total of $1 million in milestone payments to the Company. The Company was seeking damages in the amount of no less than $1 million, pre- and post-judgment interest under N.Y. C.P.L.R. § 5001, costs, and such further relief as the court deems just and proper.
On April 18, 2023 the state court ruled in favor of the Company. On June 16, 2023, the Company received consideration related to the breach of contract action with the Defendants that finalized a settlement agreement that was entered into by the Company and the Defendants to close the case.
(20)Quarterly Financial Information (Unaudited)
The following table sets forth the unaudited operating results for each fiscal quarter of 2024 and 2023:
| FirstQuarter | SecondQuarter | ThirdQuarter | FourthQuarter | Total | |
|---|---|---|---|---|---|
| 2024: | |||||
| Net revenues | $8,497,701 | $9,848,849 | $9,085,826 | $10,435,569 | $37,867,945 |
| Operating loss | (1,869,250) | (1,026,688) | (1,694,432) | (1,842,039) | (6,432,409) |
| Net loss | (1,902,472) | (1,102,637) | (1,536,969) | (1,901,637) | (6,443,715) |
| Net loss attributable to common shareholders | (1,946,263) | (1,085,612) | (1,544,081) | (1,903,814) | (6,479,770) |
| Loss per share attributable to common shareholders (1) | |||||
| Basic | $(0.14) | $(0.08) | $(0.11) | $(0.14) | $(0.46) |
| Diluted | $(0.14) | $(0.08) | $(0.11) | $(0.14) | $(0.46) |
| 2023: | |||||
| Net revenues | $9,224,638 | $10,888,877 | $10,085,926 | $9,353,066 | $39,552,507 |
| Operating income (loss) | (1,531,678) | 22,859 | (1,866,603) | (6,179,239) | (9,554,661) |
| Net income (loss) | 172,286 | 862,154 | (1,063,219) | (6,301,987) | (6,330,766) |
| Net income (loss) attributable to common shareholders | 192,184 | 872,200 | (1,049,298) | (6,294,406) | (6,279,320) |
| Earnings (loss) per share attributable to common shareholders (1) | |||||
| Continuing operations - basic | $0.01 | $0.06 | $(0.07) | $(0.44) | $(0.44) |
| Continuing operations - diluted | $0.01 | $0.06 | $(0.07) | $(0.44) | $(0.44) |
(1) Due to the nature of interim earnings per share calculations, the sum of the quarterly earnings (loss) per share amounts may not equal the reported earnings (loss) per share for the full year.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.