Item 1. Financial Statements
Item 1. Financial Statements (Unaudited)
CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited)
March 31, 2022 December 31, 2021
ASSETS
Current assets:
Cash and cash equivalents $ 17,266,785 $ 27,040,816
Accounts receivable, net 14,635,435 6,877,346
Inventories 9,878,680 8,429,882
Prepaid and other current assets 3,561,027 3,339,969
Total current assets 45,341,927 45,688,013
Non-current inventories 10,593,792 9,048,567
Property and equipment, net 409,121 442,635
Intangible assets, net 34,479,356 23,954,475
Goodwill 1,932,876 882,000
Operating lease right-of-use assets 761,177 1,024,200
Other assets 3,178,857 3,419,908
Total assets $ 96,697,106 $ 84,459,798
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable $ 11,447,505 $ 9,640,980
Operating lease current liabilities 766,488 969,677
Other current liabilities 12,343,405 8,668,303
Total current liabilities 24,557,398 19,278,960
Revolving line of credit 20,000,000 15,000,000
Operating lease noncurrent liabilities 22,712 90,016
Other long-term liabilities 11,323,593 7,488,844
Total liabilities 55,903,703 41,857,820
Commitments and contingencies
Equity:
Shareholders’ equity:
Common stock— no par value; 100,000,000 shares authorized; 14,730,760 and 14,742,754 shares issued and outstanding as of March 31, 2022 and December 31, 2021 , respectively
48,046,764 48,452,906
Retained earnings (deficit) ( 7,023,853 ) ( 5,638,600 )
Total shareholders’ equity 41,022,911 42,814,306
Noncontrolling interests ( 229,508 ) ( 212,328 )
Total equity 40,793,403 42,601,978
Total liabilities and equity $ 96,697,106 $ 84,459,798
See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.
1
CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited)
Three months ended March 31,
2022 2021
Net revenues $ 11,175,045 $ 10,537,159
Costs and expenses:
Cost of products sold 2,211,885 2,417,329
Selling and marketing 4,614,429 3,787,340
Research and development 1,745,136 1,257,367
General and administrative 2,302,349 2,230,509
Amortization 1,593,245 1,168,914
Total costs and expenses 12,467,044 10,861,459
Operating income (loss) ( 1,291,999 ) ( 324,300 )
Interest income 16,041 5,426
Interest expense ( 119,575 ) ( 24,417 )
Income (loss) from continuing operations before income taxes ( 1,395,533 ) ( 343,291 )
Income tax (expense) benefit ( 6,900 ) ( 7,458 )
Net income (loss) from continuing operations ( 1,402,433 ) ( 350,749 )
Discontinued operations — 495,410
Net income (loss) ( 1,402,433 ) 144,661
Net (income) loss at subsidiary attributable to noncontrolling interests 17,180 22,167
Net income (loss) attributable to common shareholders $ ( 1,385,253 ) $ 166,828
Earnings (loss) per share attributable to common shareholders
- Continuing operations - basic $ ( 0.09 ) $ ( 0.02 )
- Discontinued operations - basic — 0.03
$ ( 0.09 ) $ 0.01
- Continuing operations - diluted $ ( 0.09 ) $ ( 0.02 )
- Discontinued operations - diluted — 0.03
$ ( 0.09 ) $ 0.01
Weighted-average shares outstanding
- basic 14,691,623 14,974,663
- diluted 14,691,623 15,244,146
See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.
2
CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Three months ended March 31,
2022 2021
Cash flows from operating activities:
Net income (loss) $ ( 1,402,433 ) $ 144,661
Discontinued operations — 495,410
Net income (loss) from continuing operations ( 1,402,433 ) ( 350,749 )
Adjustments to reconcile net income (loss) from continuing operations to net cash provided by operating activities:
Depreciation and amortization expense 1,653,746 1,227,607
Share-based compensation 159,901 162,960
Increase (decrease) in non-cash contingent consideration 370,464 ( 280,020 )
Decrease (increase) in cash surrender value of life insurance policies over premiums paid 222,209 ( 76,300 )
Decrease (increase) in noncash interest expense 2,183 13,833
Net changes in assets and liabilities affecting operating activities:
Accounts receivable ( 7,758,089 ) ( 171,584 )
Inventories 2,271,484 1,868,350
Other current assets and other assets 239,862 507,102
Accounts payable and other current liabilities 4,461,389 ( 1,311,123 )
Other long-term liabilities ( 371,214 ) ( 299,937 )
Net cash provided by (used in) operating activities from continuing operations ( 150,498 ) 1,290,139
Discontinued operations — 495,410
Net cash provided by (used in) operating activities ( 150,498 ) 1,785,549
Cash flows from investing activities:
Additions to property and equipment ( 26,986 ) ( 19,458 )
Note receivable investment funding — ( 200,000 )
Cash paid for acquisitions ( 13,500,000 ) —
Additions to intangible assets ( 14,912 ) ( 98,883 )
Net cash used in investing activities ( 13,541,898 ) ( 318,341 )
Cash flows from financing activities:
Borrowings on line of credit 20,000,000 15,000,000
Repayments on line of credit ( 15,000,000 ) ( 15,000,000 )
Cash payment of contingent consideration ( 501,505 ) ( 995,277 )
Repurchase of common shares ( 580,130 ) ( 302,802 )
Net cash provided by (used in) financing activities 3,918,365 ( 1,298,079 )
Net increase (decrease) in cash and cash equivalents ( 9,774,031 ) 169,129
Cash and cash equivalents at beginning of period $ 27,040,816 $ 24,753,796
Cash and cash equivalents at end of period $ 17,266,785 $ 24,922,925
See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.
3
CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Equity
(Unaudited)
Common stock Retained earnings (deficit) Noncontrolling interests Total equity
Shares Amount
Balance, December 31, 2020 14,988,429 $ 49,121,523 $ ( 2,131,013 ) $ ( 117,116 ) $ 46,873,394
Share-based compensation 187,759 162,960 — — 162,960
Repurchase of common shares ( 91,724 ) ( 303,088 ) — — ( 303,088 )
Net income (loss) — — 166,828 ( 22,167 ) 144,661
Balance, March 31, 2021 15,084,464 $ 48,981,395 $ ( 1,964,185 ) $ ( 139,283 ) $ 46,877,927
Common stock Retained earnings (deficit) Noncontrolling interests Total equity
Shares Amount
Balance, December 31, 2021 14,742,754 $ 48,452,906 $ ( 5,638,600 ) $ ( 212,328 ) $ 42,601,978
Share-based compensation 162,155 159,901 — — 159,901
Repurchase of common shares ( 174,149 ) ( 566,043 ) — — ( 566,043 )
Net income (loss) — — ( 1,385,253 ) ( 17,180 ) ( 1,402,433 )
Balance, March 31, 2022 14,730,760 $ 48,046,764 $ ( 7,023,853 ) $ ( 229,508 ) $ 40,793,403
See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.
4
CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
(Unaudited)
(1) ORGANIZATION AND BASIS OF PRESENTATION
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 pharmaceutical products. The Company's primary target markets are hospital acute care, oncology, gastroenterology and rheumatology. These medical specialties are characterized by relatively concentrated prescriber bases that the Company believes can be served 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, oncology and field sales forces in the United States. We are continuing to build a network of international partners to register and provide our 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 control and manufacturing professionals. The Company works closely with its third-party distribution partners to make its products available in the United States.
In the opinion of management, the accompanying unaudited condensed consolidated financial statements of the Company have been prepared on a basis consistent with the December 31, 2021, audited consolidated financial statements and include all adjustments, consisting of only normal recurring adjustments, necessary to fairly present the information set forth herein. All significant intercompany accounts and transactions have been eliminated in consolidation. The unaudited condensed consolidated financial statements have been prepared in accordance with the regulations of the Securities and Exchange Commission (the “SEC”), and certain information and disclosures have been condensed or omitted as permitted by the SEC for interim period presentation. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes included in our Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 Annual Report on Form 10-K”). The results of operations for the three months ended March 31, 2022, are not necessarily indicative of the results to be expected for the entire fiscal year or any future period.
Discontinued Operations
As discussed further in Note 9, during May 2019, Cumberland entered into a Dissolution Agreement ("Dissolution Agreement") with Clinigen Healthcare Limited ("Clinigen") in which the Company returned the exclusive rights to commercialize Ethyol ® and Totect ® in the United States to Clinigen. Under the terms of the Dissolution Agreement, Cumberland is no longer involved directly or indirectly with the distribution, marketing and promotion of either Ethyol or Totect or any competing products following December 31, 2019. The Company's exit from Ethyol and Totect meets the accounting criteria to be reported as discontinued operations and the discontinued operating results have been presented in the financial statements and footnotes to reflect the discontinued status of Ethyol and Totect. Refer to Note 9, for additional information.
COVID-19 Pandemic
In March 2020, the U.S. declared a health care emergency following the outbreak of the SARS-CoV-2, a novel strain of coronavirus that causes COVID-19, a respiratory illness.
Cumberland has remained open for business, as the Company is considered to be essential by the United States Department of Homeland Security. The Company has implemented measures to address the impact of the novel coronavirus on the business and taken appropriate action to protect its employees, secure the supply chain, and support the patients who can benefit from its medicines. All of the Company's employees have been given the opportunity to work remotely, and those that wish to work from Cumberland's office and laboratories are encouraged to practice the behaviors outlined by the Centers for Disease Control.
Throughout the pandemic, Cumberland has faced the same challenges affecting other companies that rely on hospital admissions and patient visits to drive revenue. Our clinical studies were impacted as fewer patients sought elective surgeries and our access to medical facilities was substantially limited. During 2020, 2021 and the three months ended March 31, 2022, we carefully monitored our supply chain, including the flow of raw materials into the plants that manufacture our products as well as the batches of finished product emerging from those facilities. Several of our brands were negatively impacted by the lockdowns and postponement of physician office visits and elective procedures. However, we are fortunate to have a diversified product portfolio, with other brands delivering a strong performance during the pandemic.
5
Cumberland relies on third-party organizations around the world to supply components, manufacture and distribute its products. The Company is aware that it may experience revenue loss, supply interruptions, time delays and incur unplanned expenses as a result of the impact of the ongoing COVID-19 pandemic. The Company continues to monitor the COVID-19 pandemic situation both in the U.S. and internationally in order to maintain its employees’ safety and well-being, while also keeping its business operating. Given the uncertainty, magnitude and impact of such changes, the Company is unable to quantify the impact on the future results as of the date of this filing.
Recent Accounting Guidance
Recent Accounting Pronouncements - Not Yet Adopted
In June 2016, the Financial Accounting Standards Board ("FASB") issued 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 will be required to use a new forward-looking “expected loss” model that generally will result in the earlier recognition of allowances for losses. For available-for-sale debt securities with unrealized losses, companies will measure credit losses in a manner similar to what they do today, except that the losses will be recognized as allowances rather than as reductions in the amortized cost of the securities. Companies will have to disclose additional information, including information they use to track credit quality by year of origination for most financing receivables. Companies will apply the ASU’s provisions as a cumulative-effect adjustment, if any, to retained earnings 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 will adopt both ASU 2016-13 and ASU 2019-05 on January 1, 2023. The adoption of ASU 2016-13 and ASU 2019-05 are not expected to have a material impact on the Company’s consolidated financial statements.
Accounting Policies:
Use of Estimates
The preparation of the condensed 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 and (3) valuation of contingent consideration liabilities associated with business combinations.
Operating Segments
The Company has one 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, has concluded 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 and total revenues are primarily attributable to U.S. customers.
6
(2) EARNINGS (LOSS) PER SHARE
The following table reconciles the numerator and denominator used to calculate diluted earnings (loss) per share for the three months ended March 31, 2022 and 2021:
Three months ended March 31,
2022 2021
Numerator:
Net income (loss) from continuing operations $ ( 1,402,433 ) $ ( 350,749 )
Discontinued operations — 495,410
Net income (loss) ( 1,402,433 ) 144,661
Net income (loss) at subsidiary attributable to noncontrolling interest 17,180 22,167
Net income (loss) attributable to common shareholders $ ( 1,385,253 ) $ 166,828
Denominator:
Weighted-average shares outstanding – basic 14,691,623 14,974,663
Dilutive effect of other securities — 269,483
Weighted-average shares outstanding – diluted 14,691,623 15,244,146
As of March 31, 2022 and 2021, restricted stock awards and options to purchase 131,225 and 215,600 shares of common stock, respectively, were outstanding but were not included in the computation of diluted earnings per share because the effect would be antidilutive.
7
(3) REVENUES
Product Revenues
The Company accounts for revenues from contracts with customers under ASC 606, which became effective January 1, 2018.
The Company’s net revenues consisted of the following for the three months ended March 31, 2022 and 2021:
Three months ended March 31,
2022 2021
Products:
Kristalose $ 3,945,097 $ 2,994,378
Sancuso 3,397,209 —
Vibativ 2,501,434 5,052,243
Caldolor 959,634 1,539,496
Vaprisol ( 117,000 ) 1,134,264
Acetadote 111,090 117,191
Omeclamox-Pak 22,737 ( 450,263 )
RediTrex 59,226 ( 32,252 )
Other revenue 295,618 182,102
Total net revenues $ 11,175,045 $ 10,537,159
The Omeclamox-Pak revenue for the first quarter of 2022 and 2021 was the result of Cumberland currently being out of commercial inventory of this product. The packager for our Omeclamox-Pak product encountered financial difficulties due to the impact of COVID-19. They are under new management and are in the process of a reorganization. Discussions with the packager are ongoing. In the first quarter of 2022, the amounts noted were normal adjustments by channel partners. Net revenue was impacted by product return adjustments.
With regard to Vaprisol, we are in the process of transitioning to a new manufacturer and expect FDA approval later this year.
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 are 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.
Other revenues also include funding from federal grant programs including those secured by CET through the Small Business Administration as well as lease income generated by CET’s Life Sciences Center. The Life Sciences Center is a research center that provides scientists with access to flexible lab space and other resources to develop biomedical products. Grant revenue from these programs totaled approximately $ 0.04 million and $ 0.1 million for the three months ended March 31, 2022 and 2021, respectively.
8
(4) INVENTORIES
The Company works closely with third parties to manufacture and package finished goods for sale. Based on the arrangements with the manufacturer or packager, the Company will either take title to the finished goods at the time of shipment or at the time of arrival at the Company’s warehouses. The Company then holds such goods in inventory until distribution and sale. These finished goods 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 inventory for potential losses due to excess, obsolete or slow-moving goods by comparing sales history and projections to the inventory on hand. When evidence indicates that the carrying value may not be recoverable, a charge is taken to reduce the inventory to its current net realizable value. At March 31, 2022 and December 31, 2021, the Company had recognized and maintained cumulative net realizable value charges for potential obsolescence and discontinuance losses of approximately $ 0.6 million and $ 1.4 million, respectively.
The Company is responsible for the purchase of the active pharmaceutical ingredient (“API”) for Kristalose and maintains the inventory at third-party packagers. As that API is consumed in production, the value of the API is transferred from raw materials to finished goods. API for the Company's Vaprisol brand is also included in the raw materials inventory at March 31, 2022 and December 31, 2021. Consigned inventory represents Authorized Generic inventory stored with our partner until shipment.
As part of the Vibativ acquisition, Cumberland 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. For the Sancuso acquisition, Cumberland acquired $ 3.0 million of work in progress non-current inventory. At March 31, 2022 and December 31, 2021, total non-current inventory, including Vibativ, Sancuso and our clinical trial drug ifetroban, was $ 10.6 million and $ 9.0 million, respectively. The Company had $ 0.2 million and $ 0.5 million of Vibativ finished goods included in non-current inventory at March 31, 2022 and December 31, 2021, respectively. The Company also has obtained $ 0.2 million and $ 0.4 million of finished goods in non-current inventory for API related to its ifetroban clinical initiatives at March 31, 2022 and December 31, 2021, respectively.
At March 31, 2022 and December 31, 2021 the Company's net inventories consisted of the following:
March 31, 2022 December 31, 2021
Raw materials and work in process $ 15,004,954 $ 12,374,983
Consigned inventory 129,049 164,378
Finished goods 5,338,469 4,939,088
Total inventories 20,472,472 17,478,449
less non-current inventories ( 10,593,792 ) ( 9,048,567 )
Total inventories classified as current $ 9,878,680 $ 8,429,882
9
(5) LEASES
Cumberland’s significant operating leases include the lease of approximately 25,500 square feet of office space in Nashville, Tennessee for its corporate headquarters. This lease currently expires in October 2022. The Company's operating leases also include the lease of approximately 14,200 square feet of wet laboratory and office space in Nashville, Tennessee by CET, our majority-owned subsidiary, where it operates the CET Life Sciences Center. This lease currently expires in April 2023.
Operating lease liabilities are 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 Cumberland’s leases do not contain implicit borrowing rates, the incremental borrowing rates were calculated based on information available at January 1, 2019. Incremental borrowing rates reflect the Company’s estimated interest rates for collateralized borrowings over similar lease terms. The weighted-average incremental borrowing rate used to discount the present value of the remaining lease payments is 7.42 %. The weighted-average remaining lease term at March 31, 2022 is 0.8 years.
On November 15, 2021, Cumberland entered into a lease, pursuant to which the Company will lease approximately 16,631 rentable square feet of space (the “Leased Premise”) at the new development Broadwest located in Nashville, Tennessee with 1600 West End Avenue Partners, LLC. The Leased Premise will serve as the Company's new corporate headquarters. The initial term of the Lease is one hundred fifty-seven ( 157 ) months, with two consecutive options to renew for a period of five years each, and will commence on the earlier of November 1, 2022, the date on which Cumberland takes occupancy of the Leased Premise, or the date which Cumberland receives a temporary or permanent certificate of occupancy for the Leased Premise.
Lease Position
At March 31, 2022 and December 31, 2021, the Company's lease assets and liabilities were as follows:
Right-of-Use Assets March 31, 2022 December 31, 2021
Operating lease right-of-use assets $ 761,177 $ 1,024,200
Lease Liabilities March 31, 2022 December 31, 2021
Operating lease current liabilities $ 766,488 $ 969,677
Operating lease noncurrent liabilities 22,712 90,016
Total $ 789,200 $ 1,059,693
Excluding the Broadwest agreement, cumulative future minimum sublease income under non-cancelable operating subleases totals approximately $ 0.1 million and will be paid through the leases ending in October 2022 and April 2023. 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 Lease Liabilities at March 31, 2022
Operating Leases
2022 730,829
2023 92,477
Total lease payments 823,306
Less: Interest 34,106
Present value of lease liabilities $ 789,200
Rent expense is recognized over the expected term of the lease, including renewal option periods, if applicable, on a straight-line basis as a component of general and administrative expense. Rent expense and sublease income were as follows:
Three months ended March 31,
2022 2021
Rent expense $ 285,963 $ 227,395
Sublease income $ 161,804 $ 178,029
10
(6) SHAREHOLDERS’ EQUITY AND DEBT
Share repurchases
Cumberland currently has a share repurchase program to repurchase up to $ 10 million of its common stock pursuant to Rule 10b-18 of the Securities Exchange Act of 1934. In January 2019, the Company's Board of Directors established the current $ 10 million repurchase program to replace the prior authorizations. During the three months ended March 31, 2022 and March 31, 2021, the Company repurchased 174,149 shares and 91,724 shares of common stock for approximately $ 0.6 million and $ 0.3 million, respectively. At March 31, 2022, approximately $ 4.2 million of common shares was left to repurchase under this program.
Share purchases and sales
During the Company's March 2022 trading window, several members of Cumberland's Board of Directors entered into share purchase agreements of the Company's stock pursuant to Rule 10b5-1 of the Securities Exchange Act of 1934. These purchases are designed to increase ownership in the Company by the members of the Board. These purchases began in April 2022.
Share Sales
In November 2017, Cumberland filed a 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 allowed the Company to sell common shares at market prices, along with an agreement with B. Riley FBR Inc. to support such a placement of shares. The Company filed an updated Form S-3 with the SEC in December 2020, which was declared effective in January 2021. On December 27, 2021, 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 $ 19 million. The Company intends to continue an ATM feature through B. Riley FBR, Inc. that would allow the Company to issue shares of its common stock. The Company did not issue any shares under an ATM during the three months ended March 31, 2022 or March 31, 2021.
Restricted Share Grants and Incentive Stock Options
During the three months ended March 31, 2022 and March 31, 2021, the Company issued 65,225 shares and 35,850 shares of restricted stock to employees and directors, respectively. Restricted stock issued to employees generally cliff-vests on the fourth anniversary of the date of grant and for directors on the one-year anniversary of the date of grant. During the three months ended March 31, 2022 and 2021, the Company also issued 166,350 and 172,350 incentive stock options, respectively, to employees that cliff-vest on the fourth anniversary of the date of grant, that are set to expire in March 2032 and 2031. Stock compensation expense is presented as a component of general and administrative expense in the condensed consolidated statements of operations.
Debt Agreement
On March 31, 2022, the Company and Pinnacle Bank entered into a Seventh Amendment to the Revolving Credit Loan Agreement (the "Pinnacle Agreement") to revise and update the Maximum Funded Debt Ratio financial covenant and to delete from the Pinnacle Agreement the Funded Debt to Tangible Capital Ratio financial covenant. These changes were made to more appropriately reflect the impact from the Sancuso acquisition.
On December 31, 2021, the Company and Pinnacle Bank entered into the Fifth Amendment to the Revolving Credit Note and the Sixth Amendment to the Revolving Credit Loan Agreement in order to increase the principal amount of the Note from $ 15 million to $ 20 million.
On October 28, 2021, the Company and Pinnacle Bank entered into a Fourth Amendment to the Revolving Credit Note and Fifth Amendment ("Fifth Amendment") to the Revolving Credit Loan Agreement to renew the Revolving Credit Loan.
The original Pinnacle Agreement was dated July 2017. Beginning on August 14, 2018, and continuing until October 7, 2020, the Company and Pinnacle Bank entered into a series of amendments to extend and update the Revolving Credit Note and Revolving Credit Agreement. The Fifth Amendment extends the maturity date three years through October 1, 2024.
The interest rate on the Pinnacle Agreement is based on LIBOR plus an interest rate spread. The current pricing under the Pinnacle Agreement provides for an interest rate spread of 1.75 % to 2.75 % above LIBOR with a minimum LIBOR of 0.90 %. The applicable interest rate under the Pinnacle Agreement was 3.65 % at March 31, 2022. In addition, a fee of 0.25 % per year is charged on the unused line of credit. Interest and the unused line fee are payable quarterly. The parties have agreed on a process to determine a new interest rate benchmark at the point the LIBOR rate is expected to be discontinued over the next 12 to 24 months.
11
As of March 31, 2022 and December 31, 2021, the Company had $ 20.0 million and $ 15.0 million, respectively, in borrowings outstanding under its revolving credit facility. The Company was in compliance with the Maximum Funded Debt Ratio financial covenant as of March 31, 2022.
Borrowings under the line of credit are collateralized by substantially all of our assets.
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, will focus on acquiring, developing, registering, and commercializing development stage and commercial stage biopharmaceuticals for China, Hong Kong and other Asian markets. The agreement provides 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 a $ 0.2 million convertible note, which was funded during the first quarter of 2021. The joint venture will seek additional future capital from additional investors and has entered into exclusive option agreements to license product candidates from both Cumberland Pharmaceuticals Inc. and Cumberland Emerging Technologies Inc.
(7) INCOME TAXES
As of March 31, 2022, the Company has approximately $ 56.6 million in federal net operating loss carryforwards including approximately $ 44.1 million of net operating loss carryforwards resulting from the exercise of nonqualified stock options. These have historically been used to significantly offset income tax obligations. The Company expects it will continue to pay minimal income taxes during 2022 and beyond, through the continued utilization of these net operating loss carryforwards, on any taxable income generated from our operations. The Company does not allocate any portion of its income tax expense (benefit) to discontinued operations.
(8) COLLABORATIVE AGREEMENTS
Cumberland 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 received related to RediTrex, 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 condensed consolidated statements of operations.
12
(9) ADDITIONS AND RETURN OF PRODUCT RIGHTS
Vibativ
During November 2018, the Company closed on an agreement with Theravance Biopharma ("Theravance") to acquire the global responsibility for Vibativ including the marketing, distribution, manufacturing and regulatory activities associated with the brand. Vibativ is a patented, Food and Drug Administration ("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 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 $ 20.0 million at the closing of the transaction and a $ 5.0 million milestone payment in early April 2019. In addition, Cumberland has agreed to pay a royalty of up to 20 % of on-going net sales of the product after the $ 2.5 million threshold is met. 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 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 quarterly.
Balance at December 31, 2021
$ 6,515,627
Cash payment of royalty during the period ( 501,505 )
Change in fair value of contingent consideration included in operating expenses 370,464
Contingent consideration earned and accrued in operating expenses —
Balance at March 31, 2022
$ 6,384,586
The contingent consideration liability of $ 6.4 million was accounted for as $ 2.3 million of other current liabilities and $ 4.1 million of other long-term liabilities on the condensed consolidated balance sheet as of March 31, 2022.
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 $ 100,000 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. During December 2020, Cumberland introduced RediTrex and the launch that took place in late 2021 will result in a $ 1.0 million milestone payment due to Nordic. This milestone payment is payable during 2022 and is included as a current liability at March 31, 2022.
Cumberland has approximately $ 2.6 million in net intangible assets related to RediTrex at March 31, 2022.
13
Sancuso Acquisition
On January 3, 2022, Cumberland acquired the FDA-approved oncology-supportive care medicine Sancuso from Kyowa Kirin, Inc., 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 – including its marketing, promotion, distribution, manufacturing and medical support activities.
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. The Company believes that $ 1.5 million of the milestone payments will be earned and paid.
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 preliminary 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 Company is working with an outside consultant firm to finalize the Sancuso valuation of the transaction which will be completed later this year. The estimates of fair value for the more significant assets and liabilities assumed were prepaid expenses $ 0.3 million, inventory $ 5.2 million, goodwill $ 1.0 million, intangible assets $ 12.1 million, milestone payable $ 1.2 million and contingent liability $ 3.9 million.
The contingent consideration liability earned and accrued in operating expenses is paid to Kyowa Kirin quarterly. The contingent consideration liability of $ 3.9 million was accounted for as $ 1.3 million of current liabilities and $ 2.6 million of other long-term liabilities on the condensed consolidated balance sheet as of March 31, 2022.
14
Ethyol and Totect
In 2016, Cumberland entered into an agreement with Clinigen for the rights and responsibilities associated with the commercialization of Ethyol in the United States. In 2017, the Company entered into another agreement with Clinigen for the rights and responsibilities associated with the commercialization of Totect in the United States.
Early in 2019, Cumberland announced a strategic review of the Company's brands, capabilities, and international partners. This review followed an accelerated business development initiative, which resulted in a series of transactions. During May 2019, Cumberland entered into the Dissolution Agreement with Clinigen in which the Company returned the exclusive rights to commercialize Ethyol and Totect in the United States to Clinigen. Under the final terms of the Dissolution Agreement, Cumberland was no longer responsible for the distribution, marketing and promotion of either Ethyol or Totect or any competing products after December 31, 2019. In exchange for the return of these product license rights and the non-compete provisions of the Dissolution Agreement, Cumberland received $ 5 million in financial consideration paid in quarterly installments over the two-years following the transition date. Cumberland recorded the first four quarterly installments totaling $ 3.0 million during 2020 and the final four installments totaling $ 2.0 million during 2021 , as discontinued operations.
The exit from Ethyol and Totect met the accounting criteria to be reported as discontinued operations. December 31, 2019, as the transition date, was the final day Cumberland was responsible for the products. Cumberland was responsible for the products through December 31, 2019 and beginning on January 1, 2020, the products' rights transitioned back to Clinigen. As a result, January 1, 2020, was the first day of discontinued operations for the Ethyol and Totect products.
The dissolution payments from Clinigen are reflected as revenue from discontinued operations. The Company did not incur expenses associated with these payments from Clinigen.
Three months ended March 31,
2022 2021
Revenues $ — $ 495,410
Income from discontinued operations $ — $ 495,410
15