On August 8, 2023 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported significantly improved financial results and a favorable overall company performance for the second quarter of 2023 (Press release, Cumberland Pharmaceuticals, AUG 8, 2023, View Source [SID1234634010]).
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Highlights include:
$10.9 million in revenue during the second quarter, an increase of 6% over the prior year period, and an increase of 18% sequentially from the first quarter of this year.
Positive earnings for the second consecutive quarter, with $1.1 million in net income for the first half of the year.
Adjusted earnings for the first half of 2023 of $4.0 million, or $0.27 a share, which is up significantly from the same period last year.
$89.4 million in total assets, $52.5 million in total liabilities, and $36.8 million of shareholders’ equity at the end of June 2023.
Cumberland will report its full second quarter 2023 financial results and provide a company update via a conference call today at 4:30 p.m. Eastern Time.
"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 Cumberland’s CEO, A.J. Kazimi. "We look forward to building on this success throughout the remainder of the year, as we continue to provide innovative products to improve patients’ lives."
Recent Company developments include:
Caldolor for Treating Infants & Supporting Study Publication
In May 2023, Cumberland announced that the FDA approved expanded labeling for its Caldolor product, an intravenously delivered formulation of ibuprofen, to now include use in infants. The non-narcotic agent may now be administered for the treatment of pain and fever in patients 3 to 6 months of age. With this newly approved labeling, Caldolor is the only non-opioid product approved to treat pain in infants that is delivered through injection.
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
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 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, Cumberland presented results from an interim analysis for the FIGHT DMDTM trial at the 29th annual Parent Project Muscular Dystrophy Conference in Dallas. The interim analysis was conducted on data from 25 patients with DMD who completed six of the 12 total months of treatment and assessments. Both doses of ifetroban were reported well tolerated in DMD participants ages 7 years of age or older. The FDA Orphan Product Division previously awarded Cumberland $1.0 million in funding under its Orphan Products Grants Program to support this trial. This was the first DMD trial awarded such funding.
In May 2023, Cumberland announced that the FDA had 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 will launch 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 has also completed Phase II clinical programs with ifetroban in patients with Hepatorenal Syndrome, Portal Hypertension and Aspirin Exasperated Respiratory Disease. Additional preclinical and pilot clinical studies of ifetroban are underway, including several investigator-initiated trials.
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 Cumberland that it had granted two barrier-to-innovation waivers that would result in refunds totaling approximately $2.8 million that the company previously paid for prescription drug program fees.
The FDA granted each waiver after concluding that Cumberland met the statutory criteria based on the innovation associated with its ifetroban clinical development programs, as the funds could be better used to advance those studies, which are designed to address a series of unmet medical needs. Cumberland received both refunds in June 2023.
Sancuso Acquisition and Approval of New Manufacturing Plant
In early 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 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 assumed commercial responsibility for the product in the U.S. – including its marketing, promotion, distribution, manufacturing and medical support activities – early last year and largely completed the transition of Sancuso to Cumberland throughout the remainder of the year. In late 2022, the FDA approved moving the product’s manufacture to a new facility, which will be source of future product supplies. In June 2023, Cumberland launched an expanded oncology sales division to feature the product, which continues to be a significant contributor to Cumberland’s business.
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 has assumed responsibility for the product in the U.S. as of July 1, 2023.
FINANCIAL RESULTS:
Net Revenue: For the three months ended June 30, 2023, net revenues were $10.9 million. Net revenue by product for the second quarter of 2023, included $4.1 million for Kristalose, $2.1 million for Vibativ, $1.9 million for Sancuso and $1.2 million for Caldolor.
Year-to-date 2023 net revenues were $20.1 million. Year-to-date net revenues by product were $8.4 million for Kristalose, $4.0 million for Vibativ, $3.8 million for Sancuso and $2.2 million for Caldolor.
Operating Expenses: Total operating expenses were $10.9 million for the second quarter of 2023 and $21.6 million for the first half of the year.
Net Income: The Net Income for the second quarter of 2023 was $0.9 million, or $0.06 a share, and $1.1 million year to date, or $0.07 a share.
Adjusted earnings: Adjusted earnings for the second quarter of 2023 were $2.3 million, or $0.16 a share and $4.0 million year to date, or $0.27 a 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 June 30, 2023, Cumberland had $89.4 million in total assets, including $18.2 million in cash and cash equivalents.
Total liabilities were $52.5 million, including $13.1 million outstanding on the Company’s revolving line of credit. Total shareholders’ equity was $36.8 million.
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 Cumberland’s website or by visiting View Source