QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | |||||||
(Address of Principal Executive Offices) | (Zip Code) |
Securities registered pursuant to Section 12(b) of the Act: | ||||||||||||||
Class | Trading Symbol | Name of exchange on which registered | ||||||||||||
Large accelerated filer | ☐ | Accelerated filer | ☐ | ||||||||||||||
☒ | Smaller reporting company | ||||||||||||||||
Emerging growth company |
June 30, 2023 | December 31, 2022 | ||||||||||
ASSETS | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Accounts receivable, net | |||||||||||
Inventories, net | |||||||||||
Prepaid and other current assets | |||||||||||
Total current assets | |||||||||||
Non-current inventories | |||||||||||
Property and equipment, net | |||||||||||
Intangible assets, net | |||||||||||
Goodwill | |||||||||||
Operating lease right-of-use assets | |||||||||||
Other assets | |||||||||||
Total assets | $ | $ | |||||||||
LIABILITIES AND EQUITY | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | $ | |||||||||
Operating lease current liabilities | |||||||||||
Other current liabilities | |||||||||||
Total current liabilities | |||||||||||
Revolving line of credit | |||||||||||
Operating lease non-current liabilities | |||||||||||
Other long-term liabilities | |||||||||||
Total liabilities | |||||||||||
Equity: | |||||||||||
Shareholders’ equity: | |||||||||||
Common stock— | |||||||||||
Accumulated deficit | ( | ( | |||||||||
Total shareholders’ equity | |||||||||||
Noncontrolling interests | ( | ( | |||||||||
Total equity | |||||||||||
Total liabilities and equity | $ | $ |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Net revenues | $ | $ | $ | $ | |||||||||||||||||||
Costs and expenses: | |||||||||||||||||||||||
Cost of products sold | |||||||||||||||||||||||
Selling and marketing | |||||||||||||||||||||||
Research and development | |||||||||||||||||||||||
General and administrative | |||||||||||||||||||||||
Amortization | |||||||||||||||||||||||
Total costs and expenses | |||||||||||||||||||||||
Operating income (loss) | ( | ( | ( | ||||||||||||||||||||
Interest income | |||||||||||||||||||||||
Other income | |||||||||||||||||||||||
Other income - gain on insurance proceeds | |||||||||||||||||||||||
Interest expense | ( | ( | ( | ( | |||||||||||||||||||
Income (loss) before income taxes | ( | ( | |||||||||||||||||||||
Income tax expense | ( | ( | ( | ( | |||||||||||||||||||
Net income (loss) | ( | ( | |||||||||||||||||||||
Net loss at subsidiary attributable to noncontrolling interests | |||||||||||||||||||||||
Net income (loss) attributable to common shareholders | $ | $ | ( | $ | $ | ( | |||||||||||||||||
Earnings (loss) per share attributable to common shareholders | |||||||||||||||||||||||
- basic | $ | $ | ( | $ | $ | ( | |||||||||||||||||
- diluted | $ | $ | ( | $ | $ | ( | |||||||||||||||||
Weighted-average shares outstanding | |||||||||||||||||||||||
- basic | |||||||||||||||||||||||
- diluted | |||||||||||||||||||||||
Six months ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
Cash flows from operating activities: | |||||||||||
Net income (loss) | $ | $ | ( | ||||||||
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | |||||||||||
Depreciation and amortization expense | |||||||||||
Share-based compensation | |||||||||||
Decrease in non-cash contingent consideration | ( | ( | |||||||||
Decrease (increase) in cash surrender value of life insurance policies over premiums paid | ( | ||||||||||
Increase in noncash interest expense | |||||||||||
Gain on receivable of life insurance proceeds | ( | ||||||||||
Net changes in assets and liabilities affecting operating activities: | |||||||||||
Accounts receivable | ( | ||||||||||
Inventories | ( | ||||||||||
Other current assets and other assets | ( | ||||||||||
Accounts payable and other current liabilities | |||||||||||
Other long-term liabilities | ( | ||||||||||
Net cash provided by operating activities | |||||||||||
Cash flows from investing activities: | |||||||||||
Additions to property and equipment | ( | ( | |||||||||
Cash paid for acquisitions | ( | ||||||||||
Additions to intangible assets | ( | ( | |||||||||
Net cash used in investing activities | ( | ( | |||||||||
Cash flows from financing activities: | |||||||||||
Borrowings on line of credit | |||||||||||
Repayments on line of credit | ( | ( | |||||||||
Cash payment of contingent consideration | ( | ( | |||||||||
Repurchase of common shares | ( | ( | |||||||||
Net cash provided by (used in) financing activities | ( | ||||||||||
Net decrease in cash and cash equivalents | ( | ( | |||||||||
Cash and cash equivalents at beginning of period | $ | $ | |||||||||
Cash and cash equivalents at end of period | $ | $ | |||||||||
Common stock | Accumulated deficit | Noncontrolling interests | Total equity | ||||||||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||||||
Balance, December 31, 2021 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Share-based compensation | — | — | |||||||||||||||||||||||||||
Repurchase of common shares | ( | ( | — | — | ( | ||||||||||||||||||||||||
Net loss | — | — | ( | ( | ( | ||||||||||||||||||||||||
Balance, March 31, 2022 | $ | $ | ( | $ | ( | $ |
Balance, March 31, 2022 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Share-based compensation | ( | — | — | ( | |||||||||||||||||||||||||
Repurchase of common shares | ( | ( | — | — | ( | ||||||||||||||||||||||||
Net loss | — | — | ( | ( | ( | ||||||||||||||||||||||||
Balance, June 30, 2022 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Common stock | Accumulated deficit | Noncontrolling interests | Total equity | ||||||||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||||||
Balance, December 31, 2022 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Share-based compensation | — | — | |||||||||||||||||||||||||||
Repurchase of common shares | ( | ( | — | — | ( | ||||||||||||||||||||||||
Net income (loss) | — | — | ( | ||||||||||||||||||||||||||
Balance, March 31, 2023 | $ | $ | ( | $ | ( | $ |
Balance, March 31, 2023 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Share-based compensation | — | — | — | ||||||||||||||||||||||||||
Repurchase of common shares | ( | ( | — | — | ( | ||||||||||||||||||||||||
Net income (loss) | — | — | ( | ||||||||||||||||||||||||||
Balance, June 30, 2023 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
See accompanying Notes to Unaudited Condensed Consolidated Financial Statements. |
Three months ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
Numerator: | |||||||||||
Net income (loss) attributable to common shareholders | $ | $ | ( | ||||||||
Denominator: | |||||||||||
Weighted-average shares outstanding – basic | |||||||||||
Dilutive effect of other securities | |||||||||||
Weighted-average shares outstanding – diluted | |||||||||||
Six months ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
Numerator: | |||||||||||
Net income (loss) attributable to common shareholders | $ | $ | ( | ||||||||
Denominator: | |||||||||||
Weighted-average shares outstanding – basic | |||||||||||
Dilutive effect of other securities | |||||||||||
Weighted-average shares outstanding – diluted |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Products: | |||||||||||||||||||||||
Kristalose | $ | $ | $ | $ | |||||||||||||||||||
Sancuso | |||||||||||||||||||||||
Vibativ | |||||||||||||||||||||||
Caldolor | |||||||||||||||||||||||
Acetadote | |||||||||||||||||||||||
Vaprisol | ( | ( | |||||||||||||||||||||
Omeclamox-Pak | ( | ( | |||||||||||||||||||||
RediTrex | ( | ||||||||||||||||||||||
Other revenue | |||||||||||||||||||||||
Total net revenues | $ | $ | $ | $ |
June 30, 2023 | December 31, 2022 | |||||||||||||
Raw materials and work in process | $ | $ | ||||||||||||
Consigned inventory | ||||||||||||||
Finished goods | ||||||||||||||
Total inventories | ||||||||||||||
less non-current inventories | ( | ( | ||||||||||||
Total inventories classified as current | $ | $ |
Right-of-Use Assets | June 30, 2023 | December 31, 2022 | ||||||||||||
Operating lease right-of-use assets | $ | $ |
Lease Liabilities | June 30, 2023 | December 31, 2022 | ||||||||||||
Operating lease current liabilities | $ | $ | ||||||||||||
Operating lease noncurrent liabilities | ||||||||||||||
Total | $ | $ |
Maturity of Lease Liabilities at June 30, 2023 | Operating Leases | |||||||
2023 | ||||||||
2024 | ||||||||
2025 | ||||||||
2026 | ||||||||
2027 | ||||||||
After 2027 | ||||||||
Total lease payments | ||||||||
Less: Interest | ||||||||
Present value of lease liabilities | $ |
Three months ended June 30, | Six months ended June 30, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Rent expense | $ | $ | $ | $ | |||||||||||||||||||
Sublease income | $ | $ | $ | $ |
Balance at December 31, 2022 | $ | ||||
Cash payment of royalty during the period | ( | ||||
Change in fair value of contingent consideration included in operating expenses | |||||
Contingent consideration earned and accrued in operating expenses | |||||
Balance at June 30, 2023 | $ | ||||
Balance at December 31, 2022 | $ | ||||
Cash payment of milestones and royalty during the period | ( | ||||
Change in fair value of contingent consideration included in operating expenses | ( | ||||
Contingent consideration earned and accrued in operating expenses | |||||
Balance at June 30, 2023 | $ | ||||
Three months ended June 30, | |||||||||||||||||
2023 | 2022 | Change | |||||||||||||||
Net revenues | $ | 10,888,877 | $ | 10,299,152 | $ | 589,725 | |||||||||||
Costs and expenses: | |||||||||||||||||
Cost of products sold | 1,520,774 | 2,031,884 | (511,110) | ||||||||||||||
Selling and marketing | 4,672,075 | 4,556,685 | 115,390 | ||||||||||||||
Research and development | 1,145,038 | 1,823,693 | (678,655) | ||||||||||||||
General and administrative | 2,369,883 | 2,203,975 | 165,908 | ||||||||||||||
Amortization | 1,158,248 | 1,529,453 | (371,205) | ||||||||||||||
Total costs and expenses | 10,866,018 | 12,145,690 | (1,279,672) | ||||||||||||||
Operating income (loss) | 22,859 | (1,846,538) | 1,869,397 | ||||||||||||||
Interest income | 57,061 | 15,066 | 41,995 | ||||||||||||||
Other income | 981,806 | — | 981,806 | ||||||||||||||
Other income - gain on insurance proceeds | — | 611,330 | (611,330) | ||||||||||||||
Interest expense | (192,635) | (137,624) | (55,011) | ||||||||||||||
Income (loss) before income taxes | 869,091 | (1,357,766) | 2,226,857 | ||||||||||||||
Income tax expense | (6,937) | (6,900) | (37) | ||||||||||||||
Net income (loss) | $ | 862,154 | $ | (1,364,666) | $ | 2,226,820 | |||||||||||
Three months ended June 30, | |||||||||||||||||
2023 | 2022 | Change | |||||||||||||||
Products: | |||||||||||||||||
Kristalose | $ | 4,110,718 | $ | 3,570,272 | $ | 540,446 | |||||||||||
Sancuso | 1,916,966 | 3,398,548 | (1,481,582) | ||||||||||||||
Vibativ | 2,147,826 | 1,596,821 | 551,005 | ||||||||||||||
Caldolor | 1,226,314 | 1,193,916 | 32,398 | ||||||||||||||
Acetadote | 150,163 | 126,789 | 23,374 | ||||||||||||||
Vaprisol | 23,857 | (134,621) | 158,478 | ||||||||||||||
Omeclamox-Pak | 8,062 | (26,412) | 34,474 | ||||||||||||||
RediTrex | 9,493 | 93,676 | (84,183) | ||||||||||||||
Other revenue | 1,295,478 | 480,163 | 815,315 | ||||||||||||||
Total net revenues | $ | 10,888,877 | $ | 10,299,152 | $ | 589,725 |
Financial Impact of Vibativ | Three months ended June 30, | |||||||||||||
2023 | 2022 | |||||||||||||
Net revenue (1) | $ | 3,147,826 | $ | 1,596,821 | ||||||||||
Cost of products sold (2) | 270,571 | 402,320 | ||||||||||||
Royalty and operating expenses | 597,019 | (17,957) | ||||||||||||
Vibativ contribution | $ | 2,280,236 | $ | 1,212,458 |
Financial Impact of Sancuso | Three months ended June 30, | |||||||||||||
2023 | 2022 | |||||||||||||
Net revenue | $ | 1,916,966 | $ | 3,648,548 | ||||||||||
Cost of products sold (1) | 281,828 | 360,572 | ||||||||||||
Royalty and operating expenses | 1,407,097 | 992,922 | ||||||||||||
Sancuso contribution | $ | 228,041 | $ | 2,295,054 |
Six months ended June 30, | ||||||||||||||||||||
2023 | 2022 | Change | ||||||||||||||||||
Net revenues | $ | 20,113,515 | $ | 21,474,197 | $ | (1,360,682) | ||||||||||||||
Costs and expenses: | ||||||||||||||||||||
Cost of products sold | 2,771,038 | 4,243,769 | (1,472,731) | |||||||||||||||||
Selling and marketing | 8,949,393 | 9,171,114 | (221,721) | |||||||||||||||||
Research and development | 2,644,708 | 3,568,829 | (924,121) | |||||||||||||||||
General and administrative | 4,868,876 | 4,506,324 | 362,552 | |||||||||||||||||
Amortization | 2,388,319 | 3,122,698 | (734,379) | |||||||||||||||||
Total costs and expenses | 21,622,334 | 24,612,734 | (2,990,400) | |||||||||||||||||
Operating loss | (1,508,819) | (3,138,537) | 1,629,718 | |||||||||||||||||
Interest income | 107,251 | 31,107 | 76,144 | |||||||||||||||||
Other income | 2,828,871 | — | 2,828,871 | |||||||||||||||||
Other income - gain on insurance proceeds | — | 611,330 | (611,330) | |||||||||||||||||
Interest expense | (378,988) | (257,199) | (121,789) | |||||||||||||||||
Income (loss) before income taxes | 1,048,315 | (2,753,299) | 3,801,614 | |||||||||||||||||
Income tax expense | (13,875) | (13,800) | (75) | |||||||||||||||||
Net income (loss) | $ | 1,034,440 | $ | (2,767,099) | $ | 3,801,539 | ||||||||||||||
Six months ended June 30, | |||||||||||||||||
2023 | 2022 | Change | |||||||||||||||
Products: | |||||||||||||||||
Kristalose | $ | 8,425,846 | $ | 7,515,368 | $ | 910,478 | |||||||||||
Sancuso | 3,803,759 | 6,795,758 | (2,991,999) | ||||||||||||||
Vibativ | 3,996,013 | 4,098,255 | (102,242) | ||||||||||||||
Caldolor | 2,161,356 | 2,153,546 | 7,810 | ||||||||||||||
Vaprisol | 39,866 | (251,623) | 291,489 | ||||||||||||||
Acetadote | 320,019 | 237,884 | 82,135 | ||||||||||||||
Omeclamox-Pak | 5,544 | (3,676) | 9,220 | ||||||||||||||
RediTrex | (131,552) | 152,904 | (284,456) | ||||||||||||||
Other revenue | 1,492,664 | 775,781 | 716,883 | ||||||||||||||
Total net revenues | $ | 20,113,515 | $ | 21,474,197 | $ | (1,360,682) |
Financial Impact of Vibativ | Six months ended June 30, | |||||||||||||
2023 | 2022 | |||||||||||||
Net revenue (1) | $ | 4,996,013 | $ | 4,248,255 | ||||||||||
Cost of products sold (2) | 517,313 | 1,329,480 | ||||||||||||
Royalty and operating expenses | 1,116,627 | 663,360 | ||||||||||||
Vibativ contribution | $ | 3,362,073 | $ | 2,255,415 |
Financial Impact of Vibativ | Since Acquisition | |||||||
Net revenue (1) | $ | 48,754,498 | ||||||
Cost of products sold (2) | 16,242,420 | |||||||
Royalty and operating expenses | 7,653,817 | |||||||
Vibativ contribution | $ | 24,858,261 |
Financial Impact of Sancuso | Six months ended June 30, | |||||||||||||
2023 | 2022 | |||||||||||||
Net revenue | $ | 3,803,759 | $ | 7,045,758 | ||||||||||
Cost of products sold (1) | 571,306 | 748,836 | ||||||||||||
Royalty and operating expenses | 1,822,804 | 1,903,022 | ||||||||||||
Sancuso contribution | $ | 1,409,649 | $ | 4,393,900 |
Financial Impact of Sancuso | Since Acquisition | |||||||
Net revenue | $ | 17,359,362 | ||||||
Cost of products sold (1) | 2,114,906 | |||||||
Royalty and operating expenses | 6,024,830 | |||||||
Sancuso contribution | $ | 9,219,626 |
June 30, 2023 | December 31, 2022 | ||||||||||
Cash and cash equivalents | $ | 18,249,086 | $ | 19,757,970 | |||||||
Working capital (current assets less current liabilities) | $ | 16,715,046 | $ | 17,290,378 | |||||||
Current ratio (multiple of current assets to current liabilities) | 1.6 | 1.6 | |||||||||
Revolving line of credit availability | $ | 6,851,875 | $ | 3,800,000 |
Six months ended June 30, | |||||||||||
2023 | 2022 | ||||||||||
Net cash provided by (used in): | |||||||||||
Operating activities | $ | 3,817,152 | $ | 2,180,038 | |||||||
Investing activities | (271,261) | (13,714,489) | |||||||||
Financing activities | (5,054,775) | 2,710,200 | |||||||||
Net increase (decrease) in cash and cash equivalents | $ | (1,508,884) | $ | (8,824,251) |
Period | Total Number of Shares or Units Purchased, which were also Part of the Publicly Announced Plans or Programs | Average Price Paid per Share (or Unit) | Maximum Number (or Approximate Dollar Value) of Shares that May Yet Be Purchased Under the Plans or Programs | ||||||||||||||
April | 15,270 | $ | 1.96 | $ | 3,535,851 | ||||||||||||
May | 32,427 | 1.73 | 3,479,730 | ||||||||||||||
June | 51,360 | 1.66 | 3,394,220 | ||||||||||||||
Total | 99,057 |
No. | Description | |||||||||||||
10.1 | ||||||||||||||
31.1* | ||||||||||||||
31.2* | ||||||||||||||
32.1** | ||||||||||||||
101.INS* | INLINE XBRL INSTANCE DOCUMENT - THE INSTANCE DOCUMENT DOES NOT APPEAR IN THE INTERACTIVE DATA FILE BECAUSE ITS XBRL TAGS ARE EMBEDDED WITHIN THE INLINE XBRL DOCUMENT. | |||||||||||||
101.SCH* | INLINE XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT | |||||||||||||
101.CAL* | INLINE XBRL TAXONOMY EXTENSION CALCULATION LINKBASE DOCUMENT | |||||||||||||
101.DEF* | INLINE XBRL TAXONOMY EXTENSION DEFINITION LINKBASE DOCUMENT | |||||||||||||
101.LAB* | INLINE XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT | |||||||||||||
101.PRE* | INLINE XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT | |||||||||||||
104 | COVER PAGE INTERACTIVE DATA FILE (FORMATTED AS INLINE XBRL AND CONTAINED IN EXHIBIT 101) | |||||||||||||
* | Filed herewith. | |||||||||||||
** | Furnished herewith. |
Cumberland Pharmaceuticals Inc. | |||||||||||||||||||||||
Date: | August 11, 2023 | By: | /s/ John Hamm | ||||||||||||||||||||
John Hamm | |||||||||||||||||||||||
Chief Financial Officer and Duly Authorized Officer |
1. | I have reviewed this Form 10-Q of Cumberland Pharmaceuticals Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
August 11, 2023 | By: | /s/ A.J. Kazimi | |||||||||
A.J. Kazimi | |||||||||||
Chief Executive Officer |
1. | I have reviewed this Form 10-Q of Cumberland Pharmaceuticals Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
August 11, 2023 | By: | /s/ John Hamm | |||||||||
John Hamm | |||||||||||
Chief Financial Officer |
1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
/s/ A. J. Kazimi | ||
A.J. Kazimi | ||
Chief Executive Officer | ||
August 11, 2023 | ||
/s/ John Hamm | ||
John Hamm | ||
Chief Financial Officer | ||
August 11, 2023 |
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0 | $ 0 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 14,330,990 | 14,366,616 |
Common stock, shares outstanding (in shares) | 14,330,990 | 14,366,616 |
Condensed Consolidated Statements of Operations - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Income Statement [Abstract] | ||||
Net revenues | $ 10,888,877 | $ 10,299,152 | $ 20,113,515 | $ 21,474,197 |
Costs and expenses: | ||||
Cost of products sold | 1,520,774 | 2,031,884 | 2,771,038 | 4,243,769 |
Selling and marketing | 4,672,075 | 4,556,685 | 8,949,393 | 9,171,114 |
Research and development | 1,145,038 | 1,823,693 | 2,644,708 | 3,568,829 |
General and administrative | 2,369,883 | 2,203,975 | 4,868,876 | 4,506,324 |
Amortization | 1,158,248 | 1,529,453 | 2,388,319 | 3,122,698 |
Total costs and expenses | 10,866,018 | 12,145,690 | 21,622,334 | 24,612,734 |
Operating income (loss) | 22,859 | (1,846,538) | (1,508,819) | (3,138,537) |
Interest income | 57,061 | 15,066 | 107,251 | 31,107 |
Other income - gain on insurance proceeds | 0 | 611,330 | 0 | 611,330 |
Other income | 981,806 | 0 | 2,828,871 | 0 |
Interest expense | (192,635) | (137,624) | (378,988) | (257,199) |
Income (loss) before income taxes | 869,091 | (1,357,766) | 1,048,315 | (2,753,299) |
Income tax expense | (6,937) | (6,900) | (13,875) | (13,800) |
Net income (loss) | 862,154 | (1,364,666) | 1,034,440 | (2,767,099) |
Net loss at subsidiary attributable to noncontrolling interests | 10,046 | 29,046 | 29,944 | 46,226 |
Net income (loss) attributable to common shareholders | $ 872,200 | $ (1,335,620) | $ 1,064,384 | $ (2,720,873) |
Earnings (loss) per share attributable to common shareholders | ||||
Earnings (loss) per share attributable to common shareholders - Continuing operations - basic (in dollars per share) | $ 0.06 | $ (0.09) | $ 0.07 | $ (0.19) |
Earnings (loss) per share attributable to common shareholders - Continuing operations - diluted (in dollars per share) | $ 0.06 | $ (0.09) | $ 0.07 | $ (0.19) |
Weighted-average shares outstanding | ||||
- basic (in shares) | 14,393,711 | 14,688,505 | 14,376,260 | 14,689,798 |
- diluted (in shares) | 14,554,264 | 14,688,505 | 14,570,798 | 14,689,798 |
Organization and Basis of Presentation |
6 Months Ended |
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Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND BASIS OF PRESENTATION | 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, gastroenterology and oncology. 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. Cumberland has also established international partnerships and continues to build a network of companies outside the U.S. 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 hospital, field and oncology sales teams and 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, 2022, 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, 2022 (the “2022 Annual Report on Form 10-K”). The results of operations for the three and six months ended June 30, 2023, are not necessarily indicative of the results to be expected for the entire fiscal year or any future period. Recent Accounting Guidance Recent Accounting Pronouncements 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. Please refer to Trade and Notes Receivables Policy below. 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. Trade and Note Receivables Policy Management performed a scoping exercise to ensure completeness over the application of Current Expected Credit Losses (CECL) across the various financial instruments including trade and note receivables. CECL is applicable to all financial assets measured at amortized cost. The authoritative guidance requires that all financial instruments should be evaluated, including cash equivalents such as 3-month T-Bills, even if the expected loss is determined to be zero, or materially zero. All bank balances are maintained in cash or money market funds. Therefore for the Company, this principally relates to trade receivables and two notes receivable. CECL also 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 (326-20-55-5): a.Internal or external credit score/rating b.Risk ratings or classification c.Financial asset type d.Size e.Effective interest rate f.Term g.Geographical location h.Historical or expected credit loss patterns i.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 would need to reassess 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. The adoption of Accounting Standards Codification ("ASC") 326 did not result in a material impact to the Company.
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EARNINGS (LOSS) PER SHARE | EARNINGS (LOSS) PER SHARE The following table reconciles the numerator and denominator used to calculate basic and diluted earnings (loss) per share for the three and six months ended June 30, 2023 and 2022:
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Revenues |
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Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
REVENUES | REVENUES Product Revenues The Company accounts for revenues from contracts with customers under ASC 606. The Company’s net revenues consisted of the following for the three and six months ended June 30, 2023 and 2022:
The Omeclamox-Pak net revenue for the second quarter of 2023 was impacted by our 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 we are awaiting a potential resumption of supply. For the three and six months ended June 30, 2023 and 2022, the amounts noted resulted from normal adjustments by channel partners. With regard to Vaprisol, we are in the process of transitioning to a new manufacturer, who was issued a U.S. Food and Drug Administration ("FDA") Form 483 in the second quarter of 2022. Once these FDA Form 483 related issues are satisfactorily resolved by the manufacturer, we will then resubmit our application for their facility to the FDA for approval. For the three and six months ended June 30, 2023 and 2022, net revenue was impacted by product return and accrual adjustments. 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. Other revenues also include funding from federal grant programs including those secured from the FDA and from those secured by Cumberland Emerging Technologies Inc. ("CET") through the Small Business Administration. Grant revenue from these federal grant programs totaled approximately $0.06 million and $0.04 million for the three months ended June 30, 2023 and 2022, respectively, and approximately $0.1 million and $0.08 million for the six months ended June 30, 2023 and 2022, respectively. Also in the second quarter of 2023, the Company received $1.0 million relating to a litigation settlement based on two $500,000 milestone payments due to us for the license associated with our Vibativ product. Included in other revenue is 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. This lease income, as noted in Footnote 5 - Leases, was approximately $0.1 million and $0.2 million for the three months ended June 30, 2023 and 2022, respectively, and $0.2 million and $0.3 million for the six months ended June 30, 2023 and 2022, respectively.
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INVENTORIES | 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 June 30, 2023, there were no cumulative obsolescence and discontinuance losses necessary. At December 31, 2022, the Company had recognized and maintained cumulative net realizable value charges for potential obsolescence and discontinuance losses of approximately $0.5 million. The Company is responsible for the purchase of the active pharmaceutical ingredient (“API”) for Kristalose and maintains the inventory. 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. Consigned inventory represents Authorized Generic inventory stored with our partner until shipment. 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. At June 30, 2023 and December 31, 2022, total non-current inventory, including Vibativ and our clinical trial drug ifetroban, was $6.7 million and $7.5 million, respectively. The Company had Vibativ finished goods of $0.9 million included in non-current inventory at June 30, 2023, and no non-current inventory at December 31, 2022. The Company also had $0.3 million in non-current inventory for API related to its ifetroban clinical initiatives at June 30, 2023 and December 31, 2022, and $0.2 million and $0.1 million of finished goods, respectively. At June 30, 2023 and December 31, 2022, the Company's net inventories consisted of the following:
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Leases |
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Leases [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
LEASES | LEASES On November 15, 2021, Cumberland entered into a lease (the "Lease"), pursuant to which the Company leases approximately 16,903 rentable square feet of space (the "Leased Premise") at Broadwest located in Nashville, Tennessee with 1600 West End Avenue Partners, LLC (the "Landlord"). The Leased Premise serves 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, 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 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. In addition, 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. The research lab space at CET, under an agreement amended in July 2012, is leased through April 2028. The Company also subleases a portion of the space under this lease. 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 January 1, 2019 and October 25, 2022. 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 CET leases is 10.9 years at June 30, 2023. The weighted-average incremental borrowing rate used to discount the present value of the remaining lease payments is 9.28% for the Broadwest lease and 9.9% for the remaining CET lease. Also included as a ROU asset is an embedded lease of $0.9 million related to our new manufacturer for Vaprisol. Lease Position At June 30, 2023 and December 31, 2022, the Company's lease assets and liabilities were as follows:
As of June 30, 2023, cumulative future minimum sublease income under non-cancelable operating subleases totals approximately $1.8 million and will be paid through the leases ending in April 2028. Future minimum lease payments under non-cancelable operating leases (with initial or remaining lease terms in excess of one year) are as follows:
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:
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Shareholders' Equity and Debt |
6 Months Ended |
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Jun. 30, 2023 | |
Equity and Debt [Abstract] | |
SHAREHOLDERS' EQUITY AND DEBT | SHAREHOLDERS’ EQUITY AND DEBT Share repurchases Cumberland 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. In January 2019, the Company's Board of Directors established the current $10 million repurchase program to replace the prior authorizations. During the six months ended June 30, 2023 and June 30, 2022, the Company repurchased 185,886 shares and 257,466 shares of common stock for approximately $0.4 million and $0.8 million, respectively. At June 30, 2023, approximately $3.4 million was available for the repurchase of common shares under this program. Share purchases and sales In the Company's May 2023 trading window, several members of Cumberland's Board of Directors entered into agreements for trading plans to purchase shares 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. Purchases of shares through these plans are expected to begin in August 2023. 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 six months ended June 30, 2023 or June 30, 2022. Restricted Share Grants and Incentive Stock Options During the six months ended June 30, 2023 and June 30, 2022, the Company issued 34,250 shares and 65,225 shares of restricted stock, respectively, to employees, advisors and directors. Restricted stock issued to employees and advisors 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 six months ended June 30, 2023 and 2022, the Company also issued 184,500 and 169,800 incentive stock options, respectively, to employees that cliff-vest on the fourth anniversary of the date of grant, and are set to expire in 2033 and 2032, respectively. Stock compensation expense is presented as a component of general and administrative expense in the condensed consolidated statements of operations as it relates to these restricted share grants and options. For the six months ended June 30, 2023, we recorded a credit of $0.04 million to stock compensation expense related to the forfeiture of unvested restricted stock awards. Debt Agreement On December 31, 2021, the Company entered into a Fifth Amendment to the Revolving Credit Note and Sixth Amendment (the "Sixth Amendment") to Revolving Credit Loan Agreement with Pinnacle Bank (the "Pinnacle Agreement"). The Sixth Amendment increased the principal amount by $5 million to $20 million. On October 28, 2021, the Company entered into a Fourth Amendment to the Revolving Credit Note and Fifth Amendment to Revolving Credit Loan Agreement with Pinnacle Bank. Among other terms, the Fourth Amendment extended the maturity date to October 1, 2024 and includes a specific financial covenant. In 2022, the Company and Pinnacle Bank agreed to modify the financial covenants to align with the current use of the line of credit. On March 31, 2022, the Company and Pinnacle Bank entered into a Seventh Amendment to the Revolving Credit Loan 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 June 30, 2022, the Company entered into the Eighth Amendment to the Revolving Credit Loan Agreement with Pinnacle Bank permitting the Maximum Funded Debt Ratio to be calculated on a rolling four-quarter basis to be no more than 3.00 to 1.00 for the second and third quarters of 2022 and 2.50 to 1.00 for each quarter thereafter. On September 29, 2022, the Company entered into the Ninth Amendment to the Revolving Credit Loan Agreement with Pinnacle Bank (as amended, the "Pinnacle Agreement") to update the Funded Debt Ratio to mean the ratio of (i) Funded Debt less the amount of Unrestricted Cash in excess of $8,500,000, to (ii) EBITDA, as determined at the end of each fiscal quarter on a rolling four (4) quarter basis. For the quarter ended June 30, 2023, we were in compliance with the Funded Debt Ratio financial covenant. The interest rate on the Pinnacle Agreement was based on LIBOR plus an interest rate spread. The 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 8.0% at June 30, 2023. 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 LIBOR rate is no longer used as of June 30, 2023, at which time the benchmark rate was changed from LIBOR to Term SOFR. As of June 30, 2023 and December 31, 2022, the Company had $13.1 million and $16.2 million, respectively, in borrowings outstanding under its revolving credit facility. 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.
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Income Taxes |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXESAs of June 30, 2023, the Company has approximately $53.1 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 2023 and beyond, through the continued utilization of these net operating loss carryforwards, on any taxable income generated from our operations. |
Other Income |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Other Income and Expenses [Abstract] | |
Other Income | OTHER INCOMEThe Company realized a $2.8 million gain in the first six months of 2023 for previously paid FDA prescription drug fees. In March 2023, the Company was granted a barrier-to-innovation waiver from the FDA for certain fiscal year 2022 prescription drug fees resulting in a refund of $1.8 million. In June 2023, the Company was granted another waiver from the FDA for the fiscal year 2023 fees in the amount of $1.0 million. Both of these refunds were paid by the FDA in second quarter of 2023. |
Collaborative Agreements |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative Agreements | COLLABORATIVE AGREEMENTSCumberland 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. |
Product Acquisitions And Return Of Product Rights |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Business Combinations [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Product Acquisitions And Return Of Product Rights | PRODUCT ACQUISITIONS 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, 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.
The contingent consideration liability of $4.3 million was accounted for as $1.6 million of other current liabilities and $2.7 million of other long-term liabilities on the condensed consolidated balance sheet as of June 30, 2023. 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 called 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 March 2023, Cumberland paid $1.0 million of the $3.5 million milestone payments to Kwoya Kirin for the approval by the FDA of the manufacturing site 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 were as follows: prepaid expenses of $1.8 million, inventory of $2.6 million, goodwill of $0.03 million, intangible assets of $14.1 million, milestone payable of $1.7 million and contingent liability of $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.
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Commitments and Contingencies |
6 Months Ended |
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Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIESThe company is involved in litigation arising in the normal course of business. The Company does not believe that the disposition or ultimate resolution of existing claims or lawsuits will have a material adverse effect on the business or financial condition of the Company. |
Organization and Basis of Presentation (Policies) |
6 Months Ended |
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Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Recent Accounting Guidance | Recent Accounting Guidance Recent Accounting Pronouncements 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. Please refer to Trade and Notes Receivables Policy below.
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Use of Estimates | 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.
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Operating Segments | Operating SegmentsThe 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. |
Trade and Note Receivables Policy | Trade and Note Receivables Policy Management performed a scoping exercise to ensure completeness over the application of Current Expected Credit Losses (CECL) across the various financial instruments including trade and note receivables. CECL is applicable to all financial assets measured at amortized cost. The authoritative guidance requires that all financial instruments should be evaluated, including cash equivalents such as 3-month T-Bills, even if the expected loss is determined to be zero, or materially zero. All bank balances are maintained in cash or money market funds. Therefore for the Company, this principally relates to trade receivables and two notes receivable. CECL also 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 (326-20-55-5): a.Internal or external credit score/rating b.Risk ratings or classification c.Financial asset type d.Size e.Effective interest rate f.Term g.Geographical location h.Historical or expected credit loss patterns i.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 would need to reassess 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. The adoption of Accounting Standards Codification ("ASC") 326 did not result in a material impact to the Company.
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Earnings (Loss) Per Share (Tables) |
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Reconciliation of numerator and denominator | The following table reconciles the numerator and denominator used to calculate basic and diluted earnings (loss) per share for the three and six months ended June 30, 2023 and 2022:
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Revenues (Tables) |
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Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of net revenue | The Company’s net revenues consisted of the following for the three and six months ended June 30, 2023 and 2022:
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Inventories (Tables) |
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Inventory | At June 30, 2023 and December 31, 2022, the Company's net inventories consisted of the following:
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Leases (Tables) |
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Lease Position | At June 30, 2023 and December 31, 2022, the Company's lease assets and liabilities were as follows:
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Schedule of Maturity of Lease Liabilities | Future minimum lease payments under non-cancelable operating leases (with initial or remaining lease terms in excess of one year) are as follows:
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Schedule of Rent Expense and Sublease Income | Rent expense and sublease income were as follows:
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Product Acquisitions And Return Of Product Rights (Tables) |
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Business Combinations [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Business Acquisitions by Acquisition, Contingent Consideration | 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.
The following table presents the changes in the fair value of the contingent consideration liability that is remeasured on a recurring basis.
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Organization and Basis of Presentation Organization (Details) |
6 Months Ended |
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Jun. 30, 2023
Segment
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of operating segments | 1 |
Earnings (Loss) Per Share (Details) - USD ($) |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Numerator: | ||||
Net income (loss) attributable to common shareholders | $ 872,200 | $ (1,335,620) | $ 1,064,384 | $ (2,720,873) |
Denominator: | ||||
Weighted-average shares outstanding – basic (in shares) | 14,393,711 | 14,688,505 | 14,376,260 | 14,689,798 |
Dilutive effect of other securities (in shares) | 160,553 | 0 | 194,538 | 0 |
Weighted-average shares outstanding – diluted (in shares) | 14,554,264 | 14,688,505 | 14,570,798 | 14,689,798 |
Earnings (Loss) Per Share (Details Textual) - shares |
6 Months Ended | |
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Jun. 30, 2023 |
Jun. 30, 2022 |
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Earnings Per Share [Abstract] | ||
Common stock available for purchase through restricted stock awards and options (in shares) | 413,074 | 289,975 |
Revenues - Schedule of Revenue (Details) - USD ($) |
3 Months Ended | 6 Months Ended | ||
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Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
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Products: | ||||
Revenues | $ 10,888,877 | $ 10,299,152 | $ 20,113,515 | $ 21,474,197 |
Kristalose | ||||
Products: | ||||
Revenues | 4,110,718 | 3,570,272 | 8,425,846 | 7,515,368 |
Sancuso | ||||
Products: | ||||
Revenues | 1,916,966 | 3,398,548 | 3,803,759 | 6,795,758 |
Vibativ | ||||
Products: | ||||
Revenues | 2,147,826 | 1,596,821 | 3,996,013 | 4,098,255 |
Caldolor | ||||
Products: | ||||
Revenues | 1,226,314 | 1,193,916 | 2,161,356 | 2,153,546 |
Acetadote | ||||
Products: | ||||
Revenues | 150,163 | 126,789 | 320,019 | 237,884 |
Vaprisol | ||||
Products: | ||||
Revenues | 23,857 | (134,621) | 39,866 | (251,623) |
Omeclamox-Pak | ||||
Products: | ||||
Revenues | 8,062 | (26,412) | 5,544 | (3,676) |
RediTrex | ||||
Products: | ||||
Revenues | 9,493 | 93,676 | (131,552) | 152,904 |
Other revenue | ||||
Products: | ||||
Revenues | $ 1,295,478 | $ 480,163 | $ 1,492,664 | $ 775,781 |
Revenues - Additional Information (Details) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023
USD ($)
payment
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
payment
|
Jun. 30, 2022
USD ($)
|
|
Revenue from External Customer [Line Items] | ||||
Revenues | $ 10,888,877 | $ 10,299,152 | $ 20,113,515 | $ 21,474,197 |
Sublease income | 130,842 | 161,804 | $ 245,499 | 296,237 |
Vibativ | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||
Revenue from External Customer [Line Items] | ||||
Milestone payments received | $ 1,000,000 | |||
Milestone payments, number of payments | payment | 2 | 2 | ||
Milestone payments, receivable | $ 500,000 | $ 500,000 | ||
Grant | ||||
Revenue from External Customer [Line Items] | ||||
Revenues | $ 60,000.00 | $ 40,000.00 | $ 100,000 | $ 80,000.00 |
Inventories (Narrative) (Details) - USD ($) |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Inventory [Line Items] | ||
Obsolescence and discontinuance losses | $ 0 | $ 500,000 |
Non-current inventories | 6,694,452 | 7,527,167 |
Finished goods, net of reserve | 4,636,673 | 4,322,166 |
Ifetroban Clinical | ||
Inventory [Line Items] | ||
Non-current inventories | 300,000 | 300,000 |
Finished goods, net of reserve | 200,000 | 100,000 |
Vibativ | ||
Inventory [Line Items] | ||
Non-current inventories | 15,600,000 | |
Finished goods, net of reserve | $ 900,000 | $ 0 |
Inventories (Schedule of Inventories) (Details) - USD ($) |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Inventory | ||
Raw materials and work in process | $ 12,859,432 | $ 12,899,659 |
Consigned inventory | 126,753 | 168,923 |
Finished goods | 4,636,673 | 4,322,166 |
Total inventories | 17,622,858 | 17,390,748 |
less non-current inventories | (6,694,452) | (7,527,167) |
Total inventories classified as current | $ 10,928,406 | $ 9,863,581 |
Leases - Lease Position (Details) - USD ($) |
Jun. 30, 2023 |
Dec. 31, 2022 |
---|---|---|
Leases [Abstract] | ||
Operating lease right-of-use assets | $ 6,831,502 | $ 5,218,403 |
Operating lease current liabilities | 320,837 | 172,910 |
Operating lease noncurrent liabilities | 5,477,040 | 4,586,301 |
Total | $ 5,797,877 | $ 4,759,211 |
Leases (Schedule of Lease Liabilities Maturity and Future Minimum Lease Commitments) (Details) |
Jun. 30, 2023
USD ($)
|
---|---|
Maturity of Lease Liabilities at June 30, 2023 | |
2023 | $ 422,975 |
2024 | 863,320 |
2025 | 836,100 |
2026 | 909,911 |
2027 | 934,180 |
After 2027 | 5,588,192 |
Total lease payments | 9,554,678 |
Less: Interest | 3,756,801 |
Present value of lease liabilities | $ 5,797,877 |
Leases - Rent Expense (Details) - USD ($) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Leases [Abstract] | ||||
Rent expense | $ 226,772 | $ 285,963 | $ 501,029 | $ 574,071 |
Sublease income | $ 130,842 | $ 161,804 | $ 245,499 | $ 296,237 |
Income Taxes (Details Textual) $ in Millions |
Jun. 30, 2023
USD ($)
|
---|---|
Income Tax Contingency [Line Items] | |
Net operating loss carryforwards | $ 44.1 |
Federal | |
Income Tax Contingency [Line Items] | |
Net operating loss carryforwards | $ 53.1 |
Other Income (Details) - USD ($) |
1 Months Ended | 3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|---|
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Other Income and Expenses [Abstract] | ||||||
Other income | $ 1,000,000 | $ 1,800,000 | $ 981,806 | $ 0 | $ 2,828,871 | $ 0 |
Product Acquisitions And Return Of Product Rights - Change in Consideration, Vibativ (Details) - USD ($) |
6 Months Ended | |
---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Loss Contingency Accrual [Roll Forward] | ||
Change in fair value of contingent consideration included in operating expenses | $ (476,606) | $ (68,334) |
Vibativ | ||
Loss Contingency Accrual [Roll Forward] | ||
Beginning balance | 4,154,823 | |
Cash payment of royalty during the period | (245,391) | |
Change in fair value of contingent consideration included in operating expenses | 109,185 | |
Contingent consideration earned and accrued in operating expenses | 292,232 | |
Ending balance | $ 4,310,849 |
Product Acquisitions And Return Of Product Rights - Change in Consideration, Sancuso Acquisition (Details) - USD ($) |
6 Months Ended | |
---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Loss Contingency Accrual [Roll Forward] | ||
Change in fair value of contingent consideration included in operating expenses | $ (476,606) | $ (68,334) |
Sancuso | ||
Loss Contingency Accrual [Roll Forward] | ||
Beginning balance | 4,757,000 | |
Cash payment of milestones and royalty during the period | (1,407,598) | |
Change in fair value of contingent consideration included in operating expenses | (585,792) | |
Contingent consideration earned and accrued in operating expenses | 352,390 | |
Ending balance | $ 3,116,000 |
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