NASHVILLE - Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that the Company’s product portfolio of FDA-approved brands delivered combined revenues of $9.2 million during the first quarter of 2023. Net income for the period was $0.2 million, or $0.01 a share, resulting in adjusted earnings of $1.7 million, or $0.11 a share. The Company ended the first quarter with $89 million in total assets, $53 million in total liabilities, and $36 million of shareholders’ equity.
Cumberland will report its first quarter 2023 financial results and provide a company update via a conference call and live internet webcast today at 4:30 p.m. Eastern Time.
“We are pleased to announce a steady start to 2023,” said Cumberland’s CEO, A.J. Kazimi. “As we continue to navigate through the many issues in our operating environment – supporting our patients and their quality of life is a top priority, as our team remains dedicated to delivering and developing high- quality medicines.”
RECENT COMPANY DEVELOPMENTS:
Federal NOPAIN Act
In April 2023, Cumberland announced that it expects its Caldolor® product will be eligible for special Medicare reimbursement under the Non-Opioids Prevent Addiction in the Nation Act (the “NOPAIN Act”), which was enacted as part of the Consolidated Appropriations Act of 2023.
The NOPAIN Act requires Medicare to provide separate reimbursement for non-opioid products that are used to manage pain during surgeries, conducted in outpatient hospital departments or in ambulatory surgical centers. The NOPAIN Act applies to products that are indicated to provide analgesia without acting upon the body’s opioid receptors. As a result, Cumberland expects that the NOPAIN Act will affect Medicare reimbursement for Caldolor, the Company’s non-opioid analgesic injection brand.
FDA Fee Waiver
In March 2023, the FDA informed Cumberland that it had granted a barrier-to-innovation waiver, which will result in a refund of nearly $2 million that the Company had previously paid for prescription drug program fees associated with its RediTrex®product line.
The FDA granted the barrier-to-innovation waiver after concluding that Cumberland met the statutory criteria, based on the innovation associated with Cumberland’s ifetroban clinical development programs. Cumberland’s request for the waiver provided the rationale that the funds could be better used to advance its clinical programs, which are designed to address a series of unmet medical needs.
New Office Headquarters
Cumberland has relocated its international headquarters to the Broadwest campus in the Vanderbilt/West End corridor of Nashville. The new location allows Cumberland to maintain a strong presence in the Nashville healthcare community, which represents the nation’s largest concentration of healthcare companies.
During the first quarter of 2023, the Company continued to support its international partners in their efforts to register Cumberland products in their countries:
- PiSA Pharmaceutical is preparing its submission for distribution of Caldolor in Mexico.
- Tabuk Pharmaceutical is updating the approval in Saudi Arabia in order to begin introducing Vibativ into the Middle East.
- SciClone Pharmaceuticals continues to address regulatory inquiries, as it seeks approval for Vibativ in China.
- DB Pharm Korea Co. Ltd. is working towards approval of Vibativ in South Korea, where it also distribute Caldolor.
Nordic Pharma RediTrex® Agreement Restructured
In 2022, Cumberland restructured its agreement with Nordic Pharma, who previously provided Cumberland with the license for the U.S. rights associated with the RediTrex product line. Nordic will assume the responsibility for the product in the U.S. after June 30, 2023.
During 2022, Cumberland announced its acquisition of the U.S. rights to oncology-supportive drug Sancuso® from the U.S. subsidiary of Kyowa Kirin, Inc., a Japan-based specialty pharmaceutical company. Sancuso is the first and only FDA-approved prescription patch that prevents nausea and vomiting in cancer patients receiving certain types of chemotherapy treatment. Through the acquisition, Cumberland obtained full commercial responsibility for Sancuso in the U.S., including its marketing, promotion, distribution and manufacturing. In late 2022, the FDA approved moving the product’s manufacturer to a new facility, which will be the source of future product supplies. The product continues to be a significant contributor to Cumberland’s business.
Clinical Development Program
Cumberland continues to sponsor and progress three Phase II clinical programs featuring the Company’s ifetroban product candidate. These studies involve patients with:
a. Aspirin-Exacerbated Respiratory Disease, or AERD, a severe form of asthma;
b. Systemic Sclerosis, a debilitating autoimmune disorder; and
c. Duchenne Muscular Dystrophy, a genetic neuromuscular disease.
In addition, Cumberland has been designing a fourth Phase II clinical program, which will evaluate the use of ifetroban to treat patients with Progressive Fibrosing Interstitial Lung Diseases.
Net Revenue: For the three months ended March 31, 2023, net revenues were $9.2 million.
Net revenue by product for the first quarter of 2023, included $4.3 million for Kristalose®, $1.9 million for Sancuso®, $1.8 million for Vibativ® and $0.9 million for Caldolor®.
Operating Expenses: Total operating expenses for the first quarter of 2023 were $10.8 million.
Net Income: The Net Income for the first quarter of 2023 was $0.2 million or $0.01 a share.
Adjusted earnings: Adjusted earnings for the first quarter of 2023 were $1.7 million, or 0.11 per share.
The adjusted earnings calculation does not include the benefit of the $0.2 million of Vibativ cost of goods, which were received with the product acquisition. It also does not include the benefit of the $0.3 million of Sancuso cost of goods, which were received with that product’s acquisition.
Balance Sheet: At March 31, 2023, Cumberland had $89 million in total assets, including $16 million in cash and cash equivalents.
Total liabilities were $53 million, including $16 million outstanding on the Company's revolving line of credit. Total shareholders' equity was $36 million.
ABOUT CUMBERLAND PHARMACEUTICALS:
Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on the delivery of high-quality, prescription brands designed to improve patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments.
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 www.cumberlandpharma.com.