On November 7, 2023 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined revenues of $10.1 million during the third quarter of 2023 and $30.2 million year to date (Press release, Cumberland Pharmaceuticals, NOV 7, 2023, View Source [SID1234637129]).

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Net loss for the third quarter was $1.0 million, while year-to-date net income was $15,086. Adjusted earnings were $260,146 for the third quarter and $4.2 million, or $0.29 a share, year to date. Cash flow from operations during 2023 has totaled $5.1 million.

The company ended the third quarter with $88 million in total assets, $52 million in total liabilities, and $36 million of shareholders’ equity.

"During 2023 our team has been working diligently to advance our long-term business strategy, building our brands and progressing our clinical programs," said Cumberland Pharmaceuticals CEO A.J. Kazimi. "Moreover we have refined our mission statement, to reflect our collaborative efforts and patient focus – as we provide unique products that improve the quality of their care."
Cumberland will report its full third quarter 2023 financial results and provide a company update via a conference call today at 4:30 p.m. Eastern Time.

Recent Company developments include:

New Bank Credit Facility
On September 5, 2023, Cumberland entered into a new Revolving Credit Loan Agreement with Pinnacle Bank for a three-year term. The agreement provides for an aggregate principal funding amount of up to $25 million. It provides an initial revolving credit line with $20 million of availability, and the ability of Cumberland to increase the amount to $25 million under certain conditions. The interest rate is based on Benchmark (Term SOFR) plus a spread of 2.75%, and Cumberland is subject to one financial covenant, the maintenance of a Funded Debt Ratio, determined on a quarterly basis.

New Vibativ Pediatric Study Publication

In October 2023, Cumberland announced a new publication in Antimicrobial Agents and Chemotherapy detailing the results of the first clinical study investigating the safety and pharmacokinetics of its Vibativ injection in children 2 to 17 years of age. Vibativ is an intravenous antibiotic approved by the FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia as well as complicated skin and skin structure infections caused by certain gram-positive bacteria in adults.

This is the first reported study evaluating Vibativ in pediatric patients. The results of the study suggest that a single dose of Vibativ is safe in children and they experience reduced exposure to Vibativ, compared with the same body weight-based dosing in adults.

Federal NOPAIN Act

Cumberland expects its Caldolor injection, a non-opioid analgesic 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 hospital outpatient departments or in ambulatory surgical centers. The NOPAIN Act applies, in part, to products that are indicated to provide analgesia without acting upon the body’s opioid receptors.
The reimbursement for non-opioid pain alternatives under the NOPAIN Act will apply to those products that are furnished between January 1, 2025 and January 1, 2028. It is anticipated that in 2024, the Centers for Medicare & Medicaid Services will issue regulations implementing the NOPAIN Act and detailing the conditions for, and amount of, the separate reimbursement. Cumberland submitted a comment letter along with clinical information in the third quarter, explaining why Caldolor should be included and separately reimbursed.
Caldolor is approved by the FDA for use in adults and pediatric patients 3 months and older for the management of mild to moderate pain as a sole therapy, and for the management of moderate to severe pain as an adjunct to an opioid. A series of published clinical studies have demonstrated that Caldolor significantly reduces patient pain, while also significantly reducing patients’ need for opioids.
Sancuso Acquisition and Approval of New Manufacturing Plant
Early last year, Cumberland acquired the U.S. rights to the FDA-approved oncology-supportive care medicine Sancuso from Kyowa Kirin, Inc., 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.
As of September 2023, the transition of Sancuso to Cumberland is complete. In late 2022, the FDA approved moving the product’s manufacturer to a new facility, and the production of supplies for Cumberland at that plant is now underway during the fourth quarter of 2023.
Vaprisol Supply Update
Cumberland continues to work with its new manufacturing partner for Vaprisol, Nephron Pharmaceuticals, to provide interim supplies of a special compounded conivaptan product to the market in support of critically ill patients. The companies will share in the sales of this compounded product, which has been successfully manufactured and expected to be available by the end of 2023. Cumberland then plans to file for the approval to manufacture branded Vaprisol once Nephron addresses the FDA’s Form 483 and warning letter issues.
Clinical Development Programs
Cumberland has been evaluating its ifetroban product candidate, a selective thromboxane-prostanoid receptor antagonist, in a series of clinical studies. It has been dosed in nearly 1,400 subjects and has been found to be safe and well tolerated in healthy volunteers and various patient populations.

Patient enrollment is well underway in two company 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.
Cumberland is sponsoring the FIGHT DMD trial, a multicenter, randomized, placebo-controlled Phase II study evaluating the safety, pharmacokinetics and efficacy of two doses of oral ifetroban for the treatment of the cardiomyopathy associated DMD. The trial is evaluating 12 months of oral ifetroban in 24 subjects with early-stage cardiomyopathy and 24 subjects with advanced-stage heart disease across 10 U.S. centers that specialize in DMD cardiomyopathy.
In May 2023, Cumberland announced that the FDA has cleared the Investigational New Drug Application for a Phase II study in patients with Idiopathic Pulmonary Fibrosis ("IPF"), the most common form of progressive fibrosing interstitial lung disease. As a result, the company is initiating its FIGHTING FIBROSIS trial designed to enroll 128 patients in over 20 medical centers of excellence across the U.S. This Phase II clinical trial will study the safety, tolerability and efficacy of oral ifetroban in patients with IPF. Recent studies have shown ifetroban can both prevent and enhance resolution of lung fibrosis in multiple preclinical models.
Cumberland’s plan going forward is to complete each of its company-sponsored studies, analyze their final data, announce top-line results and decide on the best development path for the registration of ifetroban, which the company continues to believe has the potential to benefit many patients with orphan diseases that represent unmet medical needs.
FINANCIAL RESULTS:
Net Revenue: For the three months ended September 30, 2023, net revenues were $10.1 million and included $3.9 million for Kristalose, $2.8 million for Vibativ, $1.9 million for Sancuso and $1.2 million for Caldolor. Year-to-date 2023 net revenues were $30.2 million and included $12.3 million for Kristalose, $6.8 million for Vibativ, $5.7 million for Sancuso and $3.3 million for Caldolor.
Operating Expenses: Total operating expenses were $12.0 million for the third quarter of 2023 and $33.6 million for the first nine months of the year.
Net Income (Loss): The net loss for the third quarter of 2023 was $1.0 million, while the year-to-date net income was $15,086.
Adjusted earnings: Adjusted earnings for the third quarter of 2023 were $260,146, or $0.02 a share and $4.2 million year to date, or $0.29 a share. The adjusted earnings calculation does not include the benefit of the $0.5 million of Vibativ cost of goods, which was received with the product acquisition. It also does not include the benefit of the $0.3 million of Sancuso cost of goods, which was received with that product’s acquisition.
Balance Sheet: At September 30, 2023, Cumberland had $87.8 million in total assets, including $18.5 million in cash and cash equivalents.
Total liabilities were $52.1 million, including $12.9 million outstanding on the Company’s revolving line of credit. Total shareholders’ equity was $36.0 million.

EARNINGS REPORT CALL:

A conference call will be held on Nov. 7, 2023, at 4:30 p.m. Eastern Time to discuss the results. To participate in the call, please register at
https://register.vevent.com/register/BI9c23410ae1a342fab9f11ecec96f52fa.
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 Cumberland’s website or by visiting View Source