CUMBERLAND PHARMACEUTICALS REPORTS 17% REVENUE GROWTH FOR FULL YEAR 2022
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported a 17% increase in net revenues for 2022, totaling $42 million, and achieved $8 million in cash flow. The company acquired Sancuso®, enhancing its oncology product lineup. In Q4 2022, net revenues reached $9.1 million, with Sancuso® contributing $2.4 million. Operating expenses were $47.7 million, up from $43.7 million in 2021. Cumberland moved its headquarters to Nashville, supporting growth and collaboration with Vanderbilt University. The company continues ongoing clinical development for ifetroban in severe diseases, while partnerships for international product launches signify growth potential.
- Net revenues increased by 17% to $42 million in 2022.
- Successful acquisition and transition of Sancuso® from Kyowa Kirin, boosting oncology offerings.
- New headquarters in Nashville supports growth and collaboration with Vanderbilt University.
- Cash flow from operations increased by 33% to $8.5 million.
- Operating expenses rose to $47.7 million, higher than $43.7 million in 2021.
- Net loss for 2022 was $5.6 million, equating to $0.38 per share.
2022 highlights include its acquisition of Sancuso® and move to new headquarters
As of
"We were able to manage our business in 2022 to deliver significant revenue growth despite facing external challenges in our operating environment," said
HIGHLIGHTS FOR THE YEAR INCLUDE:
New Headquarter Office Location
In the fourth quarter of 2022, Cumberland relocated its headquarters to the Broadwest campus in the Vanderbilt/
The move also allows Cumberland to accommodate recent and future growth. Following the relocation, Cumberland expects to expand its organization to over 100 individuals, with a majority working from the
2022 Sustainability Metrics
Cumberland continues to monitor and report on its activities and impact on the environmental, its employees and the community. The Company's key sustainability metrics for 2022 include:
- Providing 2.2 million doses of products to patients
- Safely disposing of over 2,750 pounds of expired or damaged products
- No products recalled or clinical trial terminated due for not practicing good clinical standards.
Sancuso® Acquisition
During 2022, Cumberland acquired and successfully completed the transition of Sancuso® from
To promote and support Sancuso, Cumberland formed a new sales division, Cumberland Oncology, comprised of former Kyowa Kirin sales representatives who brought extensive experience with the brand.
Caldolor® International Update
In 2022, Cumberland announced its agreement with PiSA Pharmaceutical for the registration and commercialization of Caldolor, its non-narcotic pain relief product, in
Under the terms of the agreement, Cumberland will be responsible for providing the product dossier and supplies.
Vibativ® International Updates
In
Cumberland also announced a new partnership with
In addition, Cumberland entered into an agreement with D.B. Pharm Korea to register and commercialize the Vibativ product in
Cumberland's Vibativ partner for the Chinese market, SciClone Pharmaceuticals, had their approval application in
Nordic Pharma RediTrex® Agreement Restructured
In 2022, Cumberland restructured its agreement with Nordic Pharma, who previously provided Cumberland with the license for the
In addition, Cumberland has transferred the marketing responsibilities associated with the brand to Nordic Pharma and will continue to distribute and support RediTrex during the transition period.
Cumberland continues to sponsor and progress three Phase II clinical programs featuring the Company's ifetroban product candidate. These studies involve patients with:
- Aspirin-Exacerbated Respiratory Disease, or AERD, a severe form of asthma;
- Systemic Sclerosis, a debilitating autoimmune disorder; and
- Duchenne Muscular Dystrophy, a genetic neuromuscular disease.
In addition, Cumberland has been working toward an application to the FDA for a fourth Phase II clinical program, which will evaluate the use of ifetroban to treat patients with Progressive Fibrosing Interstitial Lung Diseases.
FINANCIAL RESULTS:
Net Revenue: In 2022, net revenues were
During the fourth quarter of 2022, net revenues totaled
Operating Expenses: The 2022 operating expenses were
Earnings: Net loss for the fourth quarter of 2022 was
Adjusted Earnings: For the full year of 2022, adjusted earnings were
The adjusted earnings calculation does not include the
Cash Flow: In 2022, cash flow from operations was
Balance Sheet: At
EARNINGS REPORT CALL:
Cumberland will provide its 2022 financial results via a conference call today at
https://register.vevent.com/register/BIc9d03deed82d47389284c0538fb62962.
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided. They can also choose a "Call Me" option to have the system automatically call them at the start of the conference call.
Available on Cumberland's website for one year, a replay of the call can be accessed by visiting https://edge.media-server.com/mmc/p/roknyaes.
ABOUT
The Company's portfolio of FDA-approved brands includes:
- Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning;
- Caldolor® (ibuprofen) injection, for the treatment of pain and fever;
- Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation;
- Omeclamox®-Pak, (omeprazole, clarithromycin, amoxicillin) oral, for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
- RediTrex® (methotrexate) injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis;
- Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;
- Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and
- Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.
The Company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Aspirin-Exacerbated Respiratory Disease.
For more information on Cumberland's approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the Company's website at www.cumberlandpharma.com.
ABOUT CUMBERLAND EMERGING TECHNOLOGIES;
The mission of CET is to advance biomedical technologies and products conceived at
CET helps manage the development and commercialization process for select projects, and provides expertise on intellectual property, regulatory, manufacturing and marketing issues that are critical to successful new biomedical products.
ABOUT CUMBERLAND'S BRANDS:
Acetadote® (acetylcysteine) Injection
Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in
Caldolor® (ibuprofen) Injection
Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit www.caldolor.com.
Kristalose® (lactulose) Oral Solution
Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing and safety information, visit www.kristalose.com.
Omeclamox®-Pak (omeprazole, clarithromycin, amoxicillin)
Omeprazole is an antisecretory drug, which works by decreasing the amount of acid the stomach produces. Clarithromycin and amoxicillin are antibacterial drugs, which inhibit the growth of bacteria allowing the stomach lining to heal. Omeclamox-Pak is contraindicated in patients with a history of hypersensitivity to omeprazole, any macrolide antibiotic or penicillin. For full prescribing and safety information, visit www.omeclamox.com.
RediTrex® (methotrexate) Injection
RediTrex is a single-dose prefilled syringe containing prescription methotrexate. RediTrex is used to treat adults with severe, active rheumatoid arthritis and children with active polyarticular juvenile idiopathic arthritis, after treatment with other medicines including non-steroidal anti-inflammatory drugs (NSAIDS) have been used and did not work well. Methotrexate can control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment have failed. For full prescribing and safety information, visit www.reditrex.com.
Sancuso® (granisetron) Transdermal System
Sancuso is the only skin patch approved by the
Vaprisol® (conivaptan hydrochloride) Injection
Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. For full prescribing and safety information, including boxed warning, visit www.vaprisol.com.
Vibativ® (telavancin) for Injection
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. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin. For more information please visit www.vibativ.com.
FORWARD-LOOKING STATEMENTS:
This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the Company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the Company's control as more fully discussed in its most recent 10-K as filed with the
Consolidated Balance Sheets (Unaudited) | ||||
2022 | 2021 | |||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 19,757,970 | $ 27,040,816 | ||
Accounts receivable, net | 13,163,681 | 6,877,346 | ||
Inventories, net | 9,863,581 | 8,429,882 | ||
Prepaid and other current assets | 3,084,978 | 3,339,969 | ||
Total current assets | 45,870,210 | 45,688,013 | ||
Non-current inventory | 7,527,167 | 9,048,567 | ||
Property and equipment, net | 284,039 | 442,635 | ||
Intangible assets, net | 30,590,678 | 23,954,475 | ||
914,000 | 882,000 | |||
Operating lease right-of-use assets | 5,218,403 | 1,024,200 | ||
Other assets | 2,520,661 | 3,419,908 | ||
Total assets | $ 92,925,158 | $ 84,459,798 | ||
LIABILITIES AND EQUITY | ||||
Current liabilities: | ||||
Accounts payable | $ 10,819,011 | $ 9,640,980 | ||
Operating lease current liabilities | 172,910 | 969,677 | ||
Other current liabilities | 17,587,911 | 8,668,303 | ||
Total current liabilities | 28,579,832 | 19,278,960 | ||
Revolving line of credit | 16,200,000 | 15,000,000 | ||
Operating lease non-current liabilities | 4,586,301 | 90,016 | ||
Other long-term liabilities | 7,585,019 | 7,488,844 | ||
Total liabilities | 56,951,152 | 41,857,820 | ||
Commitments and contingencies | ||||
Equity: | ||||
Shareholders' equity: | ||||
Common stock – no par value; 100,000,000 shares authorized; | 47,474,973 | 48,452,906 | ||
Retained earnings (deficit) | (11,208,841) | (5,638,600) | ||
Total shareholders' equity | 36,266,132 | 42,814,306 | ||
Noncontrolling interests | (292,126) | (212,328) | ||
Total equity | 35,974,006 | 42,601,978 | ||
Total liabilities and equity | $ 92,925,158 | $ 84,459,798 | ||
Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited) | ||||||||
Three months ended | Years ended | |||||||
2022 | 2021 | 2022 | 2021 | |||||
Revenues: | ||||||||
Net revenues | $ 9,123,680 | $ 8,319,861 | $ 42,010,949 | $ 35,985,043 | ||||
Costs and expenses: | ||||||||
Cost of products sold | 2,650,309 | 3,325,243 | 9,118,521 | 8,811,248 | ||||
Selling and marketing | 3,379,434 | 3,305,979 | 16,660,945 | 15,015,424 | ||||
Research and development | 1,405,841 | 1,612,827 | 6,688,924 | 5,684,465 | ||||
General and administrative | 3,507,678 | 3,412,588 | 10,180,120 | 9,780,026 | ||||
Amortization | 458,222 | 1,017,220 | 5,067,368 | 4,371,300 | ||||
Total costs and expenses | 11,401,484 | 12,673,857 | 47,715,878 | 43,662,463 | ||||
Operating income (loss) | (2,277,804) | (4,353,996) | (5,704,929) | (7,677,420) | ||||
Interest income | 45,696 | 6,670 | 98,405 | 26,081 | ||||
Other income - gain on insurance proceeds | — | — | 611,330 | — | ||||
Other income | — | — | — | 2,187,140 | ||||
Interest expense | (179,456) | (27,734) | (585,995) | (98,031) | ||||
Income (loss) before income taxes | (2,411,564) | (4,375,060) | (5,581,189) | (5,562,230) | ||||
Income tax expense (benefit) | (48,150) | (12,516) | (68,850) | (34,891) | ||||
Net income (loss) from continuing operations | (2,459,714) | (4,387,576) | (5,650,039) | (5,597,121) | ||||
Discontinued operations net of tax | — | 503,318 | — | 1,994,322 | ||||
Net income (loss) | (2,459,714) | (3,884,258) | (5,650,039) | (3,602,799) | ||||
Net loss at subsidiary attributable to noncontrolling interests | 18,985 | 36,561 | 79,798 | 95,212 | ||||
Net income (loss) attributable to common shareholders | $ (2,440,729) | $ (3,847,697) | $ (5,570,241) | $ (3,507,587) | ||||
Earnings (loss) per share attributable to common shareholders: | ||||||||
-Continuing operations-basic | $ (0.17) | $ (0.29) | $ (0.38) | $ (0.37) | ||||
-Discontinuing operations-basic | — | 0.03 | — | 0.13 | ||||
Basic | $ (0.17) | $ (0.26) | $ (0.38) | $ (0.24) | ||||
-Continuing operations-diluted | $ (0.17) | $ (0.29) | $ (0.38) | $ (0.37) | ||||
-Discontinuing operations-diluted | — | 0.03 | — | 0.13 | ||||
Diluted | $ (0.17) | $ (0.26) | $ (0.38) | $ (0.24) | ||||
Weighted-average common shares outstanding: | ||||||||
Basic | 14,401,432 | 14,800,772 | 14,563,592 | 14,904,834 | ||||
Diluted | 14,401,432 | 14,800,772 | 14,563,592 | 14,904,834 | ||||
Condensed Consolidated Statements of Cash Flows Years ended (Unaudited) | |||||
2022 | 2021 | ||||
Cash flows from operating activities: | |||||
Net income (loss) | $ (5,650,039) | $ (3,602,799) | |||
Discontinued operations | — | 1,994,322 | |||
Net income (loss) from continuing operations | (5,650,039) | (5,597,121) | |||
Adjustments to reconcile net income (loss) to net cash flows provided by | |||||
Depreciation and amortization expense | 5,328,113 | 4,606,366 | |||
Share-based compensation | 447,503 | 741,867 | |||
Decrease in non-cash contingent consideration | (2,620,012) | (1,147,750) | |||
Decrease (increase) in cash surrender value of life insurance policies | 613,657 | (282,207) | |||
Noncash interest expense | 11,237 | 34,053 | |||
Noncash gain on RediTrex transaction | (37,882) | — | |||
Gain on insurance proceeds | (611,330) | — | |||
Gain on forgiveness of debt | — | (2,187,140) | |||
Net changes in assets and liabilities affecting operating activities: | |||||
Accounts receivable | (6,115,640) | 5,500,367 | |||
Inventories | 911,078 | 4,816,450 | |||
Other current assets and other assets | 689,260 | (35,568) | |||
Accounts payable and other current liabilities | 15,067,792 | (757,591) | |||
Other long-term liabilities | 419,659 | (1,343,605) | |||
Net cash provided by operating activities from continuing operations | 8,453,396 | 4,348,121 | |||
Discontinued operations | — | 1,994,322 | |||
Net cash provided by operating activities | 8,453,396 | 6,342,443 | |||
Cash flows from investing activities: | |||||
Additions to property and equipment | (102,148) | (103,532) | |||
Cash paid for acquisitions | (13,500,000) | — | |||
Life insurance policy proceeds received | 877,597 | — | |||
Proceeds from surrender of life insurance policies | — | 85,944 | |||
Premiums paid for life insurance policies | — | (33,375) | |||
Additions to intangible assets | (1,971,662) | (250,930) | |||
Return of RediTrex | 1,000,000 | — | |||
Settlement of patent litigation | 21,757 | — | |||
Note receivable investment funding | — | (200,000) | |||
Net cash used in investing activities | (13,674,456) | (501,893) | |||
2022 | 2021 | ||||
Cash flows from financing activities: | |||||
Borrowings on line of credit | 52,900,000 | 59,000,000 | |||
Payments on line of credit | (51,700,000) | (59,000,000) | |||
Payments made in connection with repurchase of common shares | (1,053,042) | (1,386,849) | |||
Cash settlement of contingent consideration | (2,208,744) | (2,166,681) | |||
Net cash used in financing activities | (2,061,786) | (3,553,530) | |||
Net increase (decrease) in cash and cash equivalents | (7,282,846) | 2,287,020 | |||
Cash and cash equivalents, beginning of year | 27,040,816 | 24,753,796 | |||
Cash and cash equivalents, end of year | $ 19,757,970 | $ 27,040,816 | |||
Reconciliation of Net Income (Loss) Attributable to Common Shareholders to Adjusted Earnings (Loss) and (Unaudited) | ||||||||
Three months ended | Three months ended | |||||||
2022 | 2022 | 2021 | 2021 | |||||
Earnings | Earnings per | Earnings | Earnings per | |||||
Net income (loss) attributable to common shareholders | $ (2,440,729) | $ (0.17) | $ (3,847,697) | $ (0.26) | ||||
Less: Net loss at subsidiary attributable to noncontrolling interests | 18,985 | — | 36,561 | — | ||||
Net income (loss) | (2,459,714) | (0.17) | (3,884,258) | (0.26) | ||||
Discontinued operations | — | — | 503,318 | 0.03 | ||||
Net income (loss) from continuing operations | $ (2,459,714) | (0.17) | (4,387,576) | (0.29) | ||||
Adjustments to net income (loss) from continuing operations | ||||||||
Income tax expense (benefit) | 48,150 | — | 12,516 | — | ||||
Depreciation and amortization | 511,483 | 0.04 | 1,077,121 | 0.07 | ||||
Share-based compensation (a) | 126,905 | 0.01 | 224,786 | 0.02 | ||||
Write-down of expired inventory (b) | 949,380 | 0.06 | 1,135,833 | 0.08 | ||||
Interest income | (45,696) | — | (6,670) | — | ||||
Interest expense | 179,456 | 0.01 | 27,734 | — | ||||
Adjusted Earnings (loss) from continuing operations | $ (690,036) | $ (0.05) | $ (1,916,256) | $ (0.13) | ||||
Diluted weighted-average common shares outstanding: | 14,401,432 | 14,800,722 | ||||||
Year ended | Year ended | |||||||
2022 | 2022 | 2021 | 2021 | |||||
Earnings | Earnings per | Earnings | Earnings per | |||||
Net income (loss) attributable to common shareholders | $ (5,570,241) | $ (0.38) | $ (3,507,587) | $ (0.23) | ||||
Less: Net loss at subsidiary attributable to noncontrolling interests | 79,798 | 0.01 | 95,212 | 0.01 | ||||
Net income (loss) | (5,650,039) | (0.38) | (3,602,799) | (0.24) | ||||
Discontinued operations | — | — | 1,994,322 | 0.14 | ||||
Net income (loss) from continuing operations | $ (5,650,039) | $ (0.38) | $ (5,597,121) | (0.38) | ||||
Adjustments to net income (loss) from continuing operations | ||||||||
Income tax expense (benefit) | 68,850 | — | 34,891 | — | ||||
Depreciation and amortization | 5,328,113 | 0.36 | 4,606,366 | 0.31 | ||||
Share-based compensation (a) | 447,503 | 0.03 | 741,867 | 0.05 | ||||
Write-down of expired inventory (b) | 1,979,390 | 0.13 | 1,135,833 | 0.08 | ||||
Gain on insurance proceeds (c) | (611,330) | (0.04) | — | — | ||||
Gain on forgiveness of debt (d) | — | — | (2,187,140) | (0.15) | ||||
Interest income | (98,405) | (0.01) | (26,081) | — | ||||
Interest expense | 585,995 | 0.04 | 98,031 | 0.01 | ||||
Adjusted Earnings (loss) from continuing operations | $ 2,050,077 | $ 0.14 | $ (1,193,354) | $ (0.08) | ||||
Diluted weighted-average common shares outstanding: | 14,809,257 | 14,904,834 | ||||||
The company provided the above adjusted supplemental financial performance measures, which are considered "non-GAAP" financial measures under applicable
Because these supplemental financial measures exclude the effect of items that will increase or decrease the company's reported results of operations, management encourages investors to review the company's consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the supplemental financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release.
Cumberland's management believes these supplemental financial performance measures are important as they are used by management, along with financial measures in accordance with GAAP, to evaluate the company's operating performance. In addition, Cumberland believes that they will be used by certain investors to measure the company's operating results. Management believes that presenting these supplemental measures provides useful information about the company's underlying performance across reporting periods on a consistent basis by excluding items that Cumberland does not believe are indicative of its core business performance or reflect long-term strategic activities. Certain of these items are not settled through cash payments and include: depreciation, amortization, share-based compensation expense and income taxes. Cumberland utilizes its net operating loss carryforwards to pay minimal income taxes. In addition, the use of these financial measures provides greater transparency to investors of supplemental information used by management in its financial and operational decision-making, including the evaluation of the company's operating performance.
The Company defines these supplemental financial measures as follows:
- Adjusted Earnings: net income (loss) adjusted for the impact of discontinued operations, income taxes, depreciation and amortization expense, share-based compensation, write-down of expired inventory, loan forgiveness and other income and interest expense.
(a) Represents the share-based compensation of Cumberland.
(b) Represents the write-down of expired inventory.
(c) Represents the gain on insurance proceeds.
(d) Represents the forgiveness of the PPP Loan by the
- Adjusted Diluted Earnings Per Share: Adjusted Earnings (loss) divided by diluted weighted-average common shares outstanding.
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