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RediTrex®, Vibativ® and Sancuso®
12 Months Ended
Dec. 31, 2022
Business Combinations [Abstract]  
RediTrex®, Vibativ® and Sancuso® RediTrex®, Vibativ® and Sancuso®
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. Cumberland will continue to distribute and support the product until then. In accordance with the terms of the amendment, Nordic has agreed to return the 180,000 restricted Cumberland shares we previously issued to Nordic which will be cancelled, refund to Cumberland the milestone payment of $1.0 million we made associated with the brand's U.S. approval and issue 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. The companies will cooperate on any transition and Cumberland will receive a long-term royalty on any Nordic sales of the product.
Cumberland had approximately $2.6 million in net intangible assets related to RediTrex at December 31, 2021.
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, 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 acquired Vibativ to further add to its product offerings, increase its net revenue and positively contribute to the Company's operating results. Cumberland expects to deduct the goodwill acquired in the acquisition for tax purposes.
In addition, Cumberland agreed to pay a royalty of up to 20% on future net sales of the product after a $2.5 million threshold is met. The future royalty payments were required to be recognized at their acquisition-date fair value as part of the contingent consideration transferred in the business combination.
The following table presents the changes in the Company's Level 3 contingent consideration liability. The contingent consideration earned and accrued in operating expenses is paid to the seller quarterly.
Contingent consideration liability
Balance at December 31, 2020$8,200,553 
Cash payment of royalty during the period(2,166,682)
Change in fair value(1,147,750)
Contingent consideration earned and accrued1,629,506 
Balance at December 31, 2021$6,515,627 
Cash payment of royalty during the period(1,133,113)
Change in fair value(2,104,690)
Contingent consideration earned and accrued876,999 
Balance at December 31, 2022$4,154,823 
The current portion of the contingent consideration liability is $1.3 million and the non-current portion is $2.8 million, as of December 31, 2022.
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.
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. The remaining milestone of $2.0 million will be paid if and when annual net revenue exceeds $20 million.
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 Company worked with an outside consultant firm to finalize the Sancuso valuation of the transaction. The fair value for the assets and liabilities assumed were as follows: prepaid expenses $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.
Balance at January 3, 2022
$3,384,000 
Cash payment of royalty during the period
(1,075,631)
Change in fair value
16,394 
Contingent consideration earned and accrued
675,237 
Balance at December 31, 2022
$3,000,000 
The current portion of the contingent consideration liability is $1.7 million and the non-current portion is $1.3 million, as of December 31, 2022.
Sancuso Intangible Assets, Goodwill, Revenue and Earnings
An outside consultant prepared the Sancuso valuation and the valuation is complete. The goodwill of $0.03 million arising from this acquisition consists largely of the synergies and economies of scale expected from combining the operations of the Company and the acquired company.
Based on discussions with Management, the identified intangible assets were valued as a composite asset referred to as the Sancuso product rights. It is comprised of:
Technology – patented and unpatented IP and know-how;
Marketing intangible assets including product trademarks/names/dress; and
Customer base to which the product is sold.
It is a common practice in the life sciences industry to value intangible assets under a portfolio approach given the nature of the intangible assets and facts and circumstances that are common to the industry. The Goodwill amount to be deducted for tax purposes is expected to be $0.03 million and will be amortized over 15 years.
Sancuso was acquired on January 3, 2022. For the year ended December 31, 2022, the amounts included in the income statement for revenue and operating profit were $13.6 million and $6.6 million, respectively.
On a pro-forma basis, the revenue and earnings of the combined entity as though the business combination had occurred in 2021 appears below:
Cumberland 2022 ResultsPro-forma 2021 Results
Net Revenue$42,010,949 50,085,043 
Operating income (loss)$(5,704,929)(5,447,420)
The 2021 pro-forma results include results for Sancuso as provided by the management of Kyowa Kirin. The Seller is a pharmaceutical company similar to Cumberland. The 2021 results for Sancuso as reported by Kyowa Kirin reflect accounting methodology and reporting which were similar to those employed by the Company.
The Company’s 2022 balance sheet reflects the full year impact of the Sancuso acquisition, as the acquisition occurred on January 3, 2022.