Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology, today provided a company update and announced second quarter 2020 financial results. Net revenues from continuing operations during the quarter were $9.6 million. Combined revenues from continued and discontinued operations were $10.3 million, as the company recorded an additional $750,000 in revenue in the second quarter associated with divested product rights.
The Company's financial position included $98 million in total assets, $49 million of total liabilities, and over $48 million of shareholders' equity at the end of the quarter.
"As the world continues to adapt to a new way of life during the pandemic, we are working hard to manage our business, secure our supply chain and ensure the ongoing delivery of our products to support patient care during these unprecedented times," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Our facilities have remained open, and we have continued to operate our business, while working to maintain compliance with the many laws and regulations we fall under as a publicly traded, pharmaceutical company. We continue to make progress toward our goal of building a specialty pharmaceutical business that delivers sustained growth, profitable operations, and long-term value."
RECENT COMPANY DEVELOPMENTS:
Special Acute Care Product Supply Arrangements
During the second quarter, Cumberland implemented three national initiatives to help medical facilities treat patients with conditions associated with COVID-19 infections including high fevers, electrolyte imbalances, and pneumonia. These initiatives included the availability of special supply and financial arrangements for the three acute care brands - Caldolor®, Vaprisol®, and Vibativ® - during this healthcare emergency.
In addition, the Company also sponsored a national program with infectious disease experts to provide information on the management of complicated respiratory infections resulting from COVID-19.
Vibativ Clinical Manuscripts
During the second quarter, the Company announced a new study published in Drugs - Real World Outcomes, detailing the positive clinical outcomes that resulted from treating patients with bacteremia or endocarditis with Vibativ.
This publication is a sub analysis of the Telavancin Observational Use Registry (TOURTM), a study conducted to record population characteristics, prescription information, and real-world clinical outcomes of patients with Gram-positive infections treated with Vibativ. The analysis suggests Vibativ is a promising and viable option for patients with bacteremia or endocarditis, including those with MRSA or another S. aureus pathogen.
Additionally, Cumberland announced the publication of two studies confirming the continued in vitro potency of telavancin. Both publications were part of continued surveillance of telavancin activity since 2011. The first publication tested a global collection of 24,408 Gram-positive clinical isolates, and the second publication tested a U.S. collection of 15,882 S. aureus isolates. Both studies documented the sustained in vitro antimicrobial activity and spectrum of telavancin-many years after its clinical approval-against Gram-positive clinical isolates collected worldwide over 7 years, from 2011 through 2017.
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.
Environmental, Social and Governance (ESG) Activities
In April 2020, Cumberland released its inaugural Sustainability Report. This report describes the Company's activities pertaining to Environmental, Social and Governance matters, otherwise known as corporate sustainability. It includes details about Cumberland's community involvement, ethical marketing, and drug safety.
The report notes that, during 2019, Cumberland provided nearly 4 million patient doses of products, safely disposed of over 9,700 pounds of expired and damaged products and had no product recalls. The Company also had no product listings on the FDA's Safety Alerts Database and no products identified in the FDA Adverse Event Reporting System during 2019.
Cumberland's board appointed Caroline R. Young, former president of the Nashville Health Care Council, as the company's first ESG board director.
Paycheck Protection Program
At the beginning of the second quarter, Cumberland received the funding of a loan from Pinnacle Bank pursuant to the Paycheck Protection Program (the "PPP") under the Federal Coronavirus Aid, Relief, and Economic Security Act ("CARES Act").
Cumberland applied for this loan after carefully considering the eligibility criteria to participate in this program and determining that the Company met these criteria. Under the terms of the PPP, certain amounts of the loan may be forgiven if they are used for qualifying expenses as described in the CARES Act. The Company intends to use the loan amount for such qualifying expenses.
Cumberland has not laid off or furloughed any employees as a result of the COVID-19 pandemic and, due to assistance from the PPP loan, the Company does not foresee doing so. Cumberland will continue to monitor and evaluate changes to this program as they emerge and will take appropriate action, if necessary.
Ifetroban Phase II Clinical Programs
Enrollment in Cumberland's clinical studies declined during the second quarter due to the COVID-19 pandemic. While enrollment of new patients is currently limited, the Company is working to ensure that patients already entered into a trial continue to receive their study drug.
Cumberland has completed a pilot Phase II study involving ifetroban in patients suffering from aspirin-exacerbated respiratory disease, a severe form of asthma. A follow-up Phase II study is currently underway for this asthma indication.
The Company is also currently evaluating ifetroban in two pilot Phase II studies in 1) patients with systemic sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 2) patients with cardiomyopathy associated with Duchenne Muscular Dystrophy. This rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles.
Cumberland is awaiting further study results before deciding on the best path for approval for ifetroban, its first new chemical entity.
Net Revenues: For the three months ended June 30, 2020, net revenues from ongoing operations were $9.6 million, compared to $9.4 million for the prior year period. Combined revenues from continued and discontinued operations during the quarter were $10.3 million as another $750,000 in revenue was recorded associated with product rights that have been divested.
Net revenue by product for the three months ended June 30, 2020 included $3.5 for Kristalose®, $3.3 million for Vibativ®, $1.2 million for Caldolor®, $0.6 million for Acetadote® (including the brand and Company's Authorized Generic), $0.2 million for Vaprisol®, and $0.01 million for Omeclamox®-Pak.
Operating Expenses: Total operating expenses for the three months ended June 30, 2020 were $11.2 million, compared to $10.8 million during the prior year period.
Earnings: Net income (loss) for the second quarter 2020 was $(0.9) million or $(0.06) a share, compared to $(0.5) million or $(0.04) a share for the prior year period.
Adjusted Earnings for the second quarter were $1.2 million or $0.08 per diluted share, compared to $0.8 million or $0.05 per diluted share for the prior year period. The definition and reconciliation of Adjusted Earnings to net income is provided in this release.
Balance Sheet: At June 30, 2020, Cumberland had $97.5 million in total assets, including $27.4 million in cash and marketable securities. Total liabilities were $49.1 million, including $17.0 million outstanding on the Company's revolving line of credit, resulting in total shareholder's equity of $48.5 million.