Document


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
________________________________

FORM 8-K
________________________________
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of Earliest Event Reported): January 3, 2020 (January 1, 2020)

CUMBERLAND PHARMACEUTICALS INC.
(Exact name of registrant as specified in its charter)
 
 
 
Tennessee
001-33637
62-1765329
 
(State or other jurisdiction of incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)
 
 
  
 
 
 
2525 West End Avenue, Suite 950, Nashville, Tennessee 37203
 
(Address of principal executive offices) (Zip Code)
 
 
 
 
(615) 255-0068
 
(Registrant’s telephone number, including area code)
 
 
 
 
 
Not Applicable
 
(Former name or former address, if changed since last report)
____________________________________________ 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Class
 
Trading Symbol
 
Name of exchanged on which registered
Common stock, no par value
 
CPIX
 
NASDAQ Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o






Item 2.01 Completion of Acquisition or Disposition of Assets

Cumberland Pharmaceuticals Inc. ("Cumberland", “we”, “our” or "the Company") is a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products.
In 2016, Cumberland entered into an agreement with Clinigen Group Plc ("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. Ethyol and Totect are collectively referred to herein as the "Products."
In May 2019 following a strategic review of its partners, products and organization, Cumberland entered into an agreement with Clinigen to return the exclusive rights to the Products (the "Agreement"). The Agreement provided for a conclusion of the Company's arrangements with Clinigen effective September 30, 2019. Under the terms of the Agreement, Cumberland will no longer distribute the Products after the transition date and will receive $5 million in financial consideration from Clinigen, paid over a two-year period. Cumberland agreed not to sell competing products during the same two-year period.
In September 2019, Clinigen and Cumberland completed an amendment to the Agreement, whereby the transition date was changed to late December 2019. Under the final terms of the amended Agreement, the Company returned the Product rights to Clinigen on December 31, 2019. Except for the Products' inventory as of December 31, 2019, no other operating assets and no liabilities were transferred to Clinigen.
The return of these Products is collectively referred to as the "Ethyol and Totect Exit" throughout the unaudited pro forma condensed consolidated financial statements. The Ethyol and Totect Exit meets 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 Exit.
The accompanying unaudited pro forma condensed consolidated statements of operations (the “Pro Forma Statements of Operations”) for the nine months ending September 30, 2019 and for the years ended December 31, 2018, 2017 and 2016 reflect the historical consolidated Statements of Operations of the Company and the unaudited historical carve-out results of operations related to the Ethyol and Totect Exit. The Pro Forma Statements of Operations give effect to the Ethyol and Totect Exit as if it had been completed on January 1, 2016, the beginning of the earliest period presented. The accompanying unaudited pro forma condensed consolidated balance sheet (the “Pro Forma Balance Sheet”) as of September 30, 2019 reflects the unaudited historical consolidated balance sheet of Cumberland and the assets and liabilities related to the Products, giving effect to the dispositions as if they had been completed on September 30, 2019.
The Pro Forma Statements of Operations do not include any material nonrecurring charges that might arise as a result of the Ethyol and Totect Exit.
The accompanying statements and related notes are being provided for illustrative purposes only and do not purport to represent what the actual consolidated results of operations or the consolidated balance sheet of Cumberland would have been had the dispositions occurred on the dates assumed, nor are they necessarily indicative of Cumberland's future consolidated results of operations or consolidated financial position. The statements are based upon currently available information and estimates and assumptions that Cumberland management believes are reasonable as of the date hereof.
The unaudited pro forma financial statements reflect adjustments that are directly attributable to the disposal and that are factually supportable and, with respect to the statements of operations, expected to have a continuing impact. Pro forma adjustments are necessary to remove amounts related to the Products' assets and liabilities and the carve-out results of operations related to the Ethyol and Totect Exit, to adjust for costs directly related to the exit, and to reflect the income tax effects related to the pro forma adjustments. As such, these illustrative pro forma financial statements do not reflect the removal of the selling and marketing costs attributable to the individuals at Cumberland responsible for direct selling and promotion of the Products. Those selling and marketing individuals who have historically supported the Products will continue with Cumberland, but their efforts are being refocused to other products. If Cumberland were to include the costs of these sales professionals, discontinued operations for the Ethyol and Totect Exit would include more expenses than currently stated in these pro forma financial statements.
The accompanying unaudited pro forma financial statements have been developed from and should be read in conjunction with the audited annual and unaudited interim condensed consolidated financial statements and related notes of Cumberland on Form 10-K for the year ended December 31, 2018 filed with the Securities and Exchange Commission (the “SEC”) on March 12, 2019, and Form 10-Q for the quarter ended September 30, 2019 filed with the SEC on November 13, 2019, respectively.






Item 9.01 Financial Statements and Exhibits
(b) Pro forma financial information.
Pursuant to Article 11 of Regulation S-X, the Company is furnishing the following unaudited pro forma condensed consolidated financial information, which is incorporated herein by reference:
(1)
Unaudited Pro Forma Condensed Consolidated Statements of Operations for the years ended December 31, 2018, 2017, and 2016, and the nine months ended September 30, 2019;

(2)
Unaudited Pro Forma Condensed Consolidated Balance Sheet as of September 30, 2019.
(d) Exhibits.
See Exhibit Index. A copy of the pro forma financial information is furnished as Exhibit 99.1.





SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
 
Cumberland Pharmaceuticals Inc.
 
 
 
 
Dated: January 3, 2020
 
 
 
By:
/s/ Michael Bonner
 
 
 
 
 
Michael Bonner
 
 
 
 
 
Chief Financial Officer
 
 
 
 
 
 
 





EXHIBIT INDEX

Exhibit No.
 
Description
 
 
 
99.1
 



Exhibit


CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Unaudited Pro Forma Condensed Consolidated Financial Information

Under the final terms of the amended Agreement, the Company returned the Product rights to Clinigen on December 31, 2019.
The return of these Products is collectively referred to as the "Ethyol and Totect Exit" throughout the unaudited pro forma condensed consolidated financial statements. The Ethyol and Totect Exit meets 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 Exit.
The accompanying unaudited pro forma condensed consolidated statements of operations (the “Pro Forma Statements of Operations”) for the nine months ending September 30, 2019 and for the years ended December 31, 2018, 2017 and 2016 reflect the historical consolidated Statements of Operations of the Company and the unaudited historical carve-out results of operations related to the Ethyol and Totect Exit. The Pro Forma Statements of Operations give effect to the Ethyol and Totect Exit as if it had been completed on January 1, 2016, the beginning of the earliest period presented. The accompanying unaudited pro forma condensed consolidated balance sheet (the “Pro Forma Balance Sheet”) as of September 30, 2019 reflects the unaudited historical consolidated balance sheet of Cumberland and the assets and liabilities related to the Products, giving effect to the dispositions as if they had been completed on September 30, 2019.
The following statements and related notes are being provided for illustrative purposes only and do not purport to represent what the actual consolidated results of operations or the consolidated balance sheet of Cumberland would have been had the dispositions occurred on the dates assumed, nor are they necessarily indicative of Cumberland's future consolidated results of operations or consolidated financial position. The statements are based upon currently available information and estimates and assumptions that Cumberland management believes are reasonable as of the date hereof.
The accompanying unaudited pro forma financial statements have been developed from and should be read in conjunction with the audited annual and unaudited interim condensed consolidated financial statements and related notes of Cumberland on Form 10-K for the year ended December 31, 2018 filed with the Securities and Exchange Commission (the “SEC”) on March 12, 2019, and Form 10-Q for the quarter ended September 30, 2019 filed with the SEC on November 13, 2019, respectively.







CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Unaudited Pro Forma Condensed Consolidated Statement of Operations
For the Nine Months ended September 30, 2019

 
Historical Cumberland
 
Ethyol and Totect Products
 
Pro Forma
 
 
 
 
 
 
Net revenues
$
33,855,265

 
$
(8,771,714
)
(a)
$
25,083,551

Costs and expenses:
 
 
 
 
 
Cost of products sold
5,933,807

 
(902,074
)
(a)
5,031,733

Selling and marketing
15,836,077

 
(4,603,905
)
(a)
11,232,172

Research and development
4,003,980

 

 
4,003,980

General and administrative
7,621,858

 

 
7,621,858

Amortization
3,085,139

 

 
3,085,139

Total costs and expenses
36,480,861

 
(5,505,979
)
 
30,974,882

Operating income (loss)
(2,625,596
)
 
(3,265,735
)
 
(5,891,331
)
Interest income
195,915

 

 
195,915

Interest expense
(216,988
)
 

 
(216,988
)
Income (loss) before income taxes
(2,646,669
)
 
(3,265,735
)
 
(5,912,404
)
Income tax expense
72,504

 

(b)
72,504

Net income (loss)
(2,574,165
)
 
(3,265,735
)
 
(5,839,900
)
Net loss at subsidiary attributable to noncontrolling interests
(2,888
)
 

 
(2,888
)
Net income (loss) attributable to common shareholders
$
(2,577,053
)
 
$
(3,265,735
)
 
$
(5,842,788
)
 
 
 
 
 
 
Earnings per share attributable to common shareholders:
 
 
 
 
 
Basic
$
(0.17
)
 
 
 
$
(0.38
)
Diluted
$
(0.17
)
 
 
 
$
(0.38
)
Weighted-average common shares outstanding:
 
 
 
 
 
Basic
15,454,159

 
 
 
15,454,159

Diluted
15,454,159

 
 
 
15,454,159

See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.






CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Unaudited Pro Forma Condensed Consolidated Statement of Operations
For the year ended December 31, 2018

 
Historical Cumberland
 
Ethyol and Totect Products
 
Pro Forma
 
 
 
 
 
 
Revenues:
 
 
 
 
 
Net product revenue
$
40,200,832

 
$
(11,396,871
)
(a)
$
28,803,961

Other revenue
540,933

 

 
540,933

Net revenues
40,741,765

 
(11,396,871
)
 
29,344,894

Costs and expenses:
 
 
 
 
 
Cost of products sold
7,378,095

 
(1,361,273
)
(a)
6,016,822

Selling and marketing
20,258,307

 
(6,253,374
)
(a)
14,004,933

Research and development
7,320,797

 

 
7,320,797

General and administrative
10,405,872

 

 
10,405,872

Amortization
2,769,466

 

 
2,769,466

Total costs and expenses
48,132,537

 
(7,614,647
)
 
40,517,890

Operating income (loss)
(7,390,772
)
 
(3,782,224
)
 
(11,172,996
)
Interest income
564,484

 

 
564,484

Interest expense
(195,848
)
 

 
(195,848
)
Income (loss) before income taxes
(7,022,136
)
 
(3,782,224
)
 
(10,804,360
)
Income tax expense
(16,636
)
 

(b)
(16,636
)
Net income (loss)
(7,038,772
)
 
(3,782,224
)
 
(10,820,996
)
Net loss at subsidiary attributable to noncontrolling interests
75,704

 

 
75,704

Net income (loss) attributable to common shareholders
$
(6,963,068
)
 
$
(3,782,224
)
 
$
(10,745,292
)
 
 
 
 
 
 
Earnings per share attributable to common shareholders:
 
 
 
 
 
Basic
$
(0.45
)
 
 
 
$
(0.69
)
Diluted
$
(0.45
)
 
 
 
$
(0.69
)
Weighted-average common shares outstanding:
 
 
 
 
 
Basic
15,614,052

 
 
 
15,614,052

Diluted
15,614,052

 
 
 
15,614,052

See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.






CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Unaudited Pro Forma Condensed Consolidated Statement of Operations
For the year ended December 31, 2017

 
Historical Cumberland
 
Ethyol and Totect Products
 
Pro Forma
 
 
 
 
 
 
Revenues:
 
 
 
 
 
Net product revenue
$
40,376,563

 
$
(14,827,504
)
(a)
$
25,549,059

Other revenue
773,568

 

 
773,568

Net revenues
41,150,131

 
(14,827,504
)
 
26,322,627

Costs and expenses:
 
 
 
 
 
Cost of products sold
7,370,585

 
(1,952,575
)
(a)
5,418,010

Selling and marketing
21,492,937

 
(8,003,759
)
(a)
13,489,178

Research and development
3,901,365

 
(32,762
)
(a)
3,868,603

General and administrative
10,030,370

 
(40,383
)
(a)
9,989,987

Amortization
2,436,222

 

 
2,436,222

Total costs and expenses
45,231,479

 
(10,029,479
)
 
35,202,000

Operating income (loss)
(4,081,348
)
 
(4,798,025
)
 
(8,879,373
)
Interest income
299,326

 

 
299,326

Interest expense
(92,904
)
 

 
(92,904
)
Income (loss) before income taxes
(3,874,926
)
 
(4,798,025
)
 
(8,672,951
)
Income tax expense
(4,174,889
)
 

(b)
(4,174,889
)
Net income (loss)
(8,049,815
)
 
(4,798,025
)
 
(12,847,840
)
Net loss at subsidiary attributable to noncontrolling interests
71,182

 

 
71,182

Net income (loss) attributable to common shareholders
$
(7,978,633
)
 
$
(4,798,025
)
 
$
(12,776,658
)
 
 
 
 
 
 
Earnings per share attributable to common shareholders:
 
 
 
 
 
Basic
$
(0.50
)
 
 
 
$
(0.80
)
Diluted
$
(0.50
)
 
 
 
$
(0.80
)
Weighted-average common shares outstanding:
 
 
 
 
 
Basic
15,911,577

 
 
 
15,911,577

Diluted
15,911,577

 
 
 
15,911,577

See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.






CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Unaudited Pro Forma Condensed Consolidated Statement of Operations
For the year ended December 31, 2016

 
Historical Cumberland
 
Ethyol and Totect Products
 
Pro Forma
 
 
 
 
 
 
Revenues:
 
 
 
 
 
Net product revenue
$
32,478,185

 
$
(838,387
)
(a)
$
31,639,798

Other revenue
547,375

 

 
547,375

Net revenues
33,025,560

 
(838,387
)
 
32,187,173

Costs and expenses:
 
 
 
 
 
Cost of products sold
5,958,660

 
(74,549
)
(a)
5,884,111

Selling and marketing
14,553,481

 
(628,353
)
(a)
13,925,128

Research and development
3,190,700

 
(967
)
(a)
3,189,733

General and administrative
8,561,811

 
(1,439
)
(a)
8,560,372

Amortization
2,194,039

 

 
2,194,039

Total costs and expenses
34,458,691

 
(705,308
)
 
33,753,383

Operating income (loss)
(1,433,131
)
 
(133,079
)
 
(1,566,210
)
Interest income
204,661

 

 
204,661

Interest expense
(106,392
)
 

 
(106,392
)
Income (loss) before income taxes
(1,334,862
)
 
(133,079
)
 
(1,467,941
)
Income tax expense
330,924

 

(b)
330,924

Net income (loss)
(1,003,938
)
 
(133,079
)
 
(1,137,017
)
Net loss at subsidiary attributable to noncontrolling interests
59,255

 

 
59,255

Net income (loss) attributable to common shareholders
$
(944,683
)
 
$
(133,079
)
 
$
(1,077,762
)
 
 
 
 
 
 
Earnings per share attributable to common shareholders:
 
 
 
 
 
Basic
$
(0.06
)
 
 
 
$
(0.07
)
Diluted
$
(0.06
)
 
 
 
$
(0.07
)
Weighted-average common shares outstanding:
 
 
 
 
 
Basic
16,236,525

 
 
 
16,236,525

Diluted
16,236,525

 
 
 
16,236,525

See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.






CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Unaudited Pro Forma Condensed Consolidated Balance Sheet
September 30, 2019
 
Historical Cumberland
 
Ethyol and Totect Products
 
Pro Forma
 
 
 
 
 
 
ASSETS
 
 
 
 
 
Current assets:
 
 
 
 
 
Cash and cash equivalents
$
26,978,424

 
$
543,907

(c)
$
27,522,331

Marketable securities
2,265,839

 

 
2,265,839

Accounts receivable, net
8,296,672

 

 
8,296,672

Inventories, net
9,864,240

 
(543,907
)
(c)
9,320,333

Prepaid and other current assets
1,992,409

 
3,000,000

(d)
4,992,409

Total current assets
49,397,584

 
3,000,000

 
52,397,584

Non-current inventories
15,329,920

 

 
15,329,920

Property and equipment, net
743,801

 

 
743,801

Intangible assets, net
31,040,213

 

 
31,040,213

Goodwill
882,000

 

 
882,000

Deferred tax assets, net
43,605

 

 
43,605

Other assets
6,328,777

 
2,000,000

(d)
8,328,777

Total assets
$
103,765,900

 
$
5,000,000

 
$
108,765,900

 
 
 
 
 
 
LIABILITIES AND EQUITY
 
 
 
 
 
Current liabilities:
 
 
 
 
 
Accounts payable
$
8,226,609

 
$

 
$
8,226,609

Other current liabilities
12,826,341

 
3,000,000

(d)
15,826,341

Total current liabilities
21,052,950

 
3,000,000

 
24,052,950

Revolving line of credit
20,000,000

 

 
20,000,000

Other long-term liabilities
11,006,022

 
2,000,000

(d)
13,006,022

Total liabilities
52,058,972

 
5,000,000

 
57,058,972

Commitments and contingencies
 
 
 
 
 
Equity:
 
 
 
 
 
Shareholders’ equity:
 
 
 
 
 
Common stock – no par value; 100,000,000 shares authorized; 15,231,278 shares issued and outstanding as of September 30, 2019
49,563,807

 

 
49,563,807

Retained earnings
2,169,101

 

 
2,169,101

Total shareholders’ equity
51,732,908

 

 
51,732,908

Noncontrolling interests
(25,980
)
 

 
(25,980
)
Total equity
51,706,928

 

 
51,706,928

Total liabilities and equity
$
103,765,900

 
$
5,000,000

 
$
108,765,900

See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.






NOTES TO UNAUDITED PRO FORMA CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1.    DESCRIPTION OF TRANSACTION
Cumberland Pharmaceuticals Inc. ("Cumberland", “we”, “our” or "the Company") is a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products.
In 2016, Cumberland entered into an agreement with Clinigen Group Plc ("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. Ethyol and Totect are collectively referred to herein as the "Products."
In May 2019, following a strategic review of its partners, products and organization, Cumberland entered into an agreement with Clinigen to return the exclusive rights to the Products (the "Agreement"). The Agreement provided for a conclusion of the Company's arrangements with Clinigen effective September 30, 2019. Under the terms of the Agreement, Cumberland will no longer distribute Ethyol or Totect after the transition date and will receive $5 million in financial consideration from Clinigen, paid over a two-year period. Cumberland agreed not to sell competing products during the same two-year period.
In September 2019, Clinigen and Cumberland completed an amendment to the Agreement, whereby the transition date was changed to late December 2019. Under the final terms of the amended Agreement, the Company returned the Products rights to Clinigen on December 31, 2019. Except for the Products' inventory as of December 31, 2019, no other operating assets and no liabilities were transferred to Clinigen.
The return of these Products is collectively referred to as the "Ethyol and Totect Exit" throughout the unaudited pro forma condensed consolidated financial statements. The Ethyol and Totect Exit meets 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 Exit.
NOTE 2.    BASIS OF PRESENTATION
These unaudited pro forma financial statements have been derived from the historical consolidated financial statements of Cumberland on Form 10-K for the years ended December 31, 2018, 2017 and 2016, filed with the Securities and Exchange Commission (the “SEC”) on March 12, 2019, and the unaudited historical condensed consolidated financial statements of Cumberland on Form 10-Q for the nine months ended September 30, 2019, filed with the SEC on November 13, 2019, and the unaudited historical carve-out financial statements related to the Ethyol and Totect Exit.
NOTE 3.    ADJUSTMENTS TO UNAUDITED PRO FORMA FINANCIAL INFORMATION
The unaudited pro forma financial statements reflect adjustments that are directly attributable to the disposal and that are factually supportable and, with respect to the statements of operations, expected to have a continuing impact. Pro forma adjustments are necessary to remove amounts related to the Products' assets and liabilities and the carve-out results of operations related to the Ethyol and Totect Exit, to adjust for costs directly related to the exit, and to reflect the income tax effects related to the pro forma adjustments. As such, these illustrative pro forma financial statements do not reflect the removal of the selling and marketing costs attributable to the individuals at Cumberland responsible for direct selling and promotion of the Products. Those selling and marketing individuals who have historically supported the Products will continue with Cumberland, but their efforts are being refocused to other products. If Cumberland were to include the costs of these sales professionals, discontinued operations for the Ethyol and Totect Exit would include more expenses than currently stated in these pro forma financial statements.
The accompanying statements have been prepared as if the disposition of the Products was completed on September 30, 2019 for balance sheet purposes and the disposition of the Ethyol and Totect Exit was completed on January 1, 2016 for statements of operations purposes, and reflect the following adjustments:
(a)
This adjustment reflects the elimination of revenues, costs of products sold, selling and marketing, research and development, and general and administrative expense related to the operations of the Products. Selling and marketing expense is primarily comprised of the royalty payments due to Clinigen. The royalty payments of 30% to 50% are based on tiered levels of net sales of the Products. The elimination of selling and marketing expenses do not reflect the removal of the selling and marketing costs attributable to the individuals at Cumberland responsible for direct selling and promotion of the Products.






(b)
This adjustment represents the estimated income tax effect of the pro forma adjustments. The tax effect of the pro forma adjustments was calculated using the historical statutory rates in effect for the periods presented, including the impact of the valuation allowance against the deferred tax assets related to the Products.

(c)
This adjustment reflects the elimination of the inventory assets for the Products sold back to Clinigen, at cost, as part of the transaction.

(d)
This adjustment reflects the $5 million in financial consideration Clinigen will pay to Cumberland over a two-year period under the terms of the Agreement. The liabilities reflect the deferred income related to these payments. This amount has not been reflected in the pro forma statements of operations as it relates to the discontinued operation.