Cumberland Pharmaceuticals Reports Revenue and Earnings Growth Second Quarter 2023
- Improved financial results
- Positive earnings
- Revenue increase
- Net income of $1.1 million
- Adjusted earnings of $4.0 million
- Total assets of $89.4 million
- FDA fee waivers
- Acquisition of Sancuso rights
- None.
Highlights include:
in revenue during the second quarter, an increase of$10.9 million 6% over the prior year period, and an increase of18% sequentially from the first quarter of this year.- Positive earnings for the second consecutive quarter, with
in net income for the first half of the year.$1.1 million - Adjusted earnings for the first half of 2023 of
, or$4.0 million a share, which is up significantly from the same period last year.$0.27 in total assets,$89.4 million in total liabilities, and$52.5 million of shareholders' equity at the end of June 2023.$36.8 million
"We have had an overall successful first half of the year, with several key developments, including FDA approval for the use of our Caldolor® product for treating infants," said
Recent Company developments include:
Caldolor for Treating Infants & Supporting Study Publication
In May 2023,
In June 2023, the Company shared the positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in newborn infants. The clinical study evaluated the safety and drug exposure profile of Caldolor in 24 hospitalized infants between the ages of 1 and 6 months who required treatment for pain or fever. The results of the study support the growing body of evidence that demonstrates Caldolor is a safe therapeutic option available to practitioners for the treatment of fever and pain in infants and children.
Clinical Development Programs
Patient enrollment is well underway in two of the company's sponsored Phase II clinical programs to evaluate ifetroban in Systemic Sclerosis, or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs; and the cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles.
In June 2023,
In May 2023,
The company plans to complete each of its company-sponsored studies, analyze their final data and announce top-line results before deciding on the best development path for the registration of ifetroban.
FDA Fee Waivers
During the second quarter of 2023, the FDA informed
The FDA granted each waiver after concluding that
Sancuso® Acquisition and Approval of New Manufacturing Plant
In early 2022,
Nordic Pharma RediTrex® Agreement Restructured
In 2022,
FINANCIAL RESULTS:
Net Revenue: For the three months ended June 30, 2023, net revenues were
Year-to-date 2023 net revenues were
Operating Expenses: Total operating expenses were
Net Income: The Net Income for the second quarter of 2023 was
Adjusted earnings: Adjusted earnings for the second quarter of 2023 were
Balance Sheet: At June 30, 2023,
Total liabilities were
EARNINGS REPORT CALL:
A conference call will be held on August 8 at 4:30 p.m. Eastern Time, to discuss the results. To participate in the call, please register at: https://register.vevent.com/register/BIeb03c2e461914b7d94f99de2f7535170.
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.
A replay of the call will be available for one year and can be accessed via
ABOUT CUMBERLAND PHARMACEUTICALS:
Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in
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;
- 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 and Systemic Sclerosis. Additionally,
For more information on
About 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
About 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.
About 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
About 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.
About Sancuso® (granisetron) Transdermal System
Sancuso is the only skin patch approved by the FDA for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the SANCUSO patch slowly and continuously releases the medicine contained in the adhesive through clean and intact skin areas into the patient's bloodstream. It can be worn for up to seven days in a row for chemotherapy regimens of up to five consecutive days. For full prescribing and safety information, visit www.sancuso.com.
About 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. The coadministration of Vaprisol with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, is contraindicated. For full prescribing and safety information, including boxed warning, visit www.vaprisol.com.
About 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.
ABOUT
Cumberland Emerging Technologies, Inc. (www.cet-fund.com) is a joint initiative between Cumberland Pharmaceuticals Inc.,
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. CET's Life Sciences Center provides laboratory space, equipment and infrastructure for CET's activities and other early-stage life sciences ventures.
FORWARD LOOKING STATEMENTS:
This press release contains forward-looking statements, which are subject to certain risks and reflect
CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES Condensed Consolidated Balance Sheets (Unaudited) | |||
June 30, 2023 | December 31, 2022 | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 18,249,086 | $ 19,757,970 | |
Accounts receivable, net | 12,218,756 | 13,163,681 | |
Inventories, net | 10,928,406 | 9,863,581 | |
Prepaid and other current assets | 2,277,885 | 3,084,978 | |
Total current assets | 43,674,133 | 45,870,210 | |
Non-current inventories | 6,694,452 | 7,527,167 | |
Property and equipment, net | 384,383 | 284,039 | |
Intangible assets, net | 28,269,781 | 30,590,678 | |
Goodwill | 914,000 | 914,000 | |
Operating lease right-of-use assets | 6,831,502 | 5,218,403 | |
Other assets | 2,607,109 | 2,520,661 | |
Total assets | $ 89,375,360 | $ 92,925,158 | |
LIABILITIES AND EQUITY | |||
Current liabilities: | |||
Accounts payable | $ 10,912,044 | $ 10,819,011 | |
Operating lease current liabilities | 320,837 | 172,910 | |
Other current liabilities | 15,726,206 | 17,587,911 | |
Total current liabilities | 26,959,087 | 28,579,832 | |
Revolving line of credit | 13,148,125 | 16,200,000 | |
Operating lease non-current liabilities | 5,477,040 | 4,586,301 | |
Other long-term liabilities | 6,954,206 | 7,585,019 | |
Total liabilities | 52,538,458 | 56,951,152 | |
Equity: | |||
Shareholders' equity: | |||
Common stock—no par value; 100,000,000 shares authorized; 14,330,990 | 47,303,429 | 47,474,973 | |
Accumulated deficit | (10,144,457) | (11,208,841) | |
Total shareholders' equity | 37,158,972 | 36,266,132 | |
Noncontrolling interests | (322,070) | (292,126) | |
Total equity | 36,836,902 | 35,974,006 | |
Total liabilities and equity | $ 89,375,360 | $ 92,925,158 |
CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES Condensed Consolidated Statements of Operations (Unaudited) | |||||||
Three months ended June 30, | Six months ended June 30, | ||||||
2023 | 2022 | 2023 | 2022 | ||||
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 loss | 22,859 | (1,846,538) | (1,508,819) | (3,138,537) | |||
Interest income | 57,061 | 15,066 | 107,251 | 31,107 | |||
Other income | 981,806 | — | 2,828,871 | — | |||
Other income - gain on insurance proceeds | — | 611,330 | — | 611,330 | |||
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 (income) 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 | |||||||
- basic | $ 0.06 | $ (0.09) | $ 0.07 | $ (0.19) | |||
- diluted | $ 0.06 | $ (0.09) | $ 0.07 | $ (0.19) | |||
Weighted-average shares outstanding | |||||||
- basic | 14,393,711 | 14,688,505 | 14,376,260 | 14,689,798 | |||
- diluted | 14,554,264 | 14,688,505 | 14,570,798 | 14,689,798 |
CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES Condensed Consolidated Statements of Cash Flows (Unaudited) | |||
Six months ended June 30, | |||
2023 | 2022 | ||
Cash flows from operating activities: | |||
Net income (loss) | $ 1,034,440 | $ (2,767,099) | |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | |||
Depreciation and amortization expense | 2,456,590 | 3,272,085 | |
Share-based compensation | 188,034 | 132,148 | |
Decrease in non-cash contingent consideration | (476,606) | (68,334) | |
Decrease (increase) in cash surrender value of life insurance policies over premiums paid | (95,997) | 598,355 | |
Gain on receivable of life insurance policy proceeds | — | (611,330) | |
Noncash interest expense | 7,809 | 4,791 | |
Net changes in assets and liabilities affecting operating activities: | |||
Accounts receivable | 944,925 | (5,527,690) | |
Inventories | (232,110) | 2,949,443 | |
Other current assets and other assets | (804,400) | 1,227,030 | |
Accounts payable and other current liabilities | 534,541 | 4,658,782 | |
Other long-term liabilities | 259,926 | (1,688,143) | |
Net cash provided by operating activities | 3,817,152 | 2,180,038 | |
Cash flows from investing activities: | |||
Additions to property and equipment | (179,453) | (164,241) | |
Cash paid for acquisitions | — | (13,500,000) | |
Additions to intangibles | (91,808) | (50,248) | |
Net cash used in investing activities | (271,261) | (13,714,489) | |
Cash flows from financing activities: | |||
Borrowings on line of credit | 16,000,000 | 39,000,000 | |
Repayments on line of credit | (19,051,875) | (35,000,000) | |
Cash payment of contingent consideration | (1,652,990) | (501,505) | |
Repurchase of common shares | (349,910) | (788,295) | |
Net cash provided by (used in) financing activities | (5,054,775) | 2,710,200 | |
Net decrease in cash and cash equivalents | (1,508,884) | (8,824,251) | |
Cash and cash equivalents at beginning of period | $ 19,757,970 | $ 27,040,816 | |
Cash and cash equivalents at end of period | $ 18,249,086 | $ 18,216,565 |
CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES Reconciliation of Net Income (loss) Attributable to Common Shareholders to Adjusted Earnings (loss) and Adjusted Diluted Earnings (loss) Per Share (Unaudited) | ||||||||
Three months ended June 30, | Three months ended June 30, | |||||||
2023 | 2023 | 2022 | 2022 | |||||
Earnings | Earnings per | Earnings | Earnings per | |||||
Net income (loss) attributable to common shareholders | $ 872,200 | $ 0.06 | $ (1,335,620) | $ (0.09) | ||||
Less: Net (income) loss at subsidiary attributable to noncontrolling interests | 10,046 | — | 29,046 | — | ||||
Net income (loss) | 862,154 | 0.06 | (1,364,666) | (0.09) | ||||
Adjustments to net income (loss) | ||||||||
Income tax expense (benefit) | 6,937 | — | 6,900 | — | ||||
Depreciation and amortization | 1,200,915 | 0.08 | 1,618,339 | 0.11 | ||||
Share-based compensation (a) | 97,878 | 0.01 | (27,753) | — | ||||
Gain on insurance proceeds (b) | — | — | (611,330) | (0.04) | ||||
Interest income | (57,061) | — | (15,066) | — | ||||
Interest expense | 192,635 | 0.01 | 137,624 | 0.01 | ||||
Adjusted Earnings (loss) and Adjusted Diluted Earnings (loss) Per Share(c)(d) | $ 2,303,458 | $ 0.16 | $ (255,952) | $ (0.01) | ||||
Diluted weighted-average common shares outstanding: | 14,554,264 | 14,688,505 | ||||||
Six months ended June 30, | Six months ended June 30, | |||||||
2023 | 2023 | 2022 | 2022 | |||||
Earnings | Earnings per | Earnings | Earnings per | |||||
Net income (loss) attributable to common shareholders | $ 1,064,384 | $ 0.07 | $ (2,720,873) | $ (0.18) | ||||
Less: Net (income) loss at subsidiary attributable to noncontrolling interests | 29,944 | — | 46,226 | — | ||||
Net income (loss) | 1,034,440 | 0.07 | (2,767,099) | (0.19) | ||||
Adjustments to net income (loss) from continuing operations | ||||||||
Income tax expense (benefit) | 13,875 | — | 13,800 | — | ||||
Depreciation and amortization | 2,456,590 | 0.17 | 3,272,085 | 0.22 | ||||
Share-based compensation (a) | 188,034 | 0.01 | 132,148 | 0.01 | ||||
Gain on insurance proceeds (b) | — | — | (611,330) | (0.04) | ||||
Interest income | (107,251) | (0.01) | (31,107) | — | ||||
Interest expense | 378,988 | 0.03 | 257,199 | 0.02 | ||||
Adjusted Earnings (loss) from continuing operations and Adjusted Diluted | $ 3,964,676 | $ 0.27 | $ 265,696 | $ 0.02 | ||||
Diluted weighted-average common shares outstanding: | 14,570,798 | 14,948,836 |
The Company provided the above adjusted supplemental financial performance measures, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. These financial measures should be considered supplemental to, and not as a substitute for, financial information prepared in accordance with Generally Accepted Accounting Principles ("GAAP"). The definition of these supplemental measures may differ from similarly titled measures used by others.
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.
The Company defines these supplemental financial measures as follows:
- Adjusted Earnings (loss): net income (loss) adjusted for the impact of income taxes, depreciation and amortization expense, share-based compensation, nonrecurring gains and interest income and interest expense.
(a) Represents the share-based compensation of
(b) Represents the gain in insurance proceeds.
(c) Adjusted Earnings includes a litigation settlement based on two
(d) Adjusted Earnings includes a gain on the refund of 2022 and 2023 FDA fees in the amount of
- Adjusted Diluted Earnings (loss) Per Share: Adjusted Earnings (loss) divided by diluted weighted-average common shares outstanding.
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SOURCE Cumberland Pharmaceuticals Inc.