On March 9, 2021 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care, gastroenterology and rheumatology, reported fourth quarter and full year 2020 financial results (Press release, Cumberland Pharmaceuticals, MAR 9, 2021, View Source [SID1234576307]). Net Revenues for the fourth quarter were $10.3 million, up 10% over the prior year period. For the full year 2020, Net Revenues totaled $37.4 million, a 9% increase over 2019. The company also recorded an additional $3.2 million in revenue during the year associated with divested product rights for two brands it is no longer distributing.
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As of December 31, 2020, the total assets of the Company were $96.5 million, including $24.8 million in cash and investments. Total Liabilities were $49.6 million, and Total Shareholder’s Equity was $47 million. Cumberland also had approximately $44 million in tax net operating loss carryforwards, resulting from the prior exercise of stock options.
2020 Highlights:
Implemented national launch of a Next Generation Caldolor product featuring a ready-to-use formulation in a pre-mixed bag
Commenced several national initiatives during 2020 to help hospitals access Cumberland’s acute care brands during the COVID-19 pandemic
Announced a series of publications featuring important new data associated with the Company’s Caldolor (ibuprofen) Injection, for the treatment of pain and fever and Vibativ (telavancin) Injection, for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections
Introduced an FDA-approved RediTrex line of injectable methotrexate products, featuring an innovative delivery system for patients with arthritis
"We are grateful that Cumberland was able to successfully manage through the pandemic during 2020, in spite of the significant market headwinds and other challenges we encountered," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Our facilities remained open, our operations continued, and our organization remained intact." He continued, "I would like to acknowledge and thank my colleagues for their continued dedication during such trying times for many. Together, we remain focused on our mission of advancing patient care through the delivery of high-quality medicines."
Caldolor
Early in 2020, Cumberland implemented a national launch of its Next Generation Caldolor product featuring a ready-to-use formulation, offering time and cost savings associated with its administration. Caldolor is a non-steroidal anti-inflammatory drug (NSAID) and may be used as the sole method of treatment for mild-moderate pain or as part of a multimodal treatment for severe pain. Cumberland’s new formulation of Caldolor comes in a pre-mixed bag that is ready for use. It is the first FDA-approved pre-mixed bag of ibuprofen.
Caldolor was also the subject of several clinical studies published during the year. These studies demonstrated that patients given Caldolor experienced less postoperative pain and had decreased opioid use. Due to these studies, Caldolor was recommended for consideration in Enhanced Recovery After Surgery protocols for the management of postoperative pain – including that of traumatic origin.
Vibativ
Cumberland launched several national initiatives during 2020 to help hospitals access the Company’s acute care brands during the healthcare emergency. Cumberland’s Vibativ product was used to help COVID-19 patients who developed secondary-bacterial infections in their lungs. Vibativ is a potent antibiotic, FDA approved to treat hospital and ventilator acquired pneumonia that can result from a variety of infectious agents. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.
Additionally, there were a series of clinical study manuscripts published during the year regarding Vibativ. One study suggested that Vibativ is a promising and viable option for patients with bacteremia or endocarditis, including those with MRSA or another S. aureus pathogen. Two other studies confirmed the continued in vitro potency of Vibativ and detailed the positive outcomes that resulted.
RediTrex
The Company implemented a soft launch of its newly FDA-approved RediTrex product line during the fourth quarter. Cumberland is now preparing for a full national launch during the second half of 2021, once product supplies are assured and market conditions return to normal. The Company believes that RediTrex will be a valuable addition to the portfolio and help further diversify and grow its business.
RediTrex is approved for patients with severe, active rheumatoid arthritis and polyarticular juvenile idiopathic arthritis who have difficulty tolerating or responding to orally delivered methotrexate. It is also approved for symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.
Omeclamox-Pak
Cumberland closely monitored its supply chain during the 2020 pandemic. This included monitoring the facilities that supply the raw materials along with those that manufacture the Company’s products. Overall, the chain remained intact with batches of finished goods shipped to the warehouses that supply the country’s hospital and retail pharmacies. However, there was one exception, as the facility packaging Omeclamox-Pak encountered financial difficulties due to the pandemic and suspended operations. Subsequently, Cumberland learned that this facility is reorganizing, and the Company awaits the resumption of its operations.
Ifetroban Phase II Clinical Programs
Cumberland’s development pipeline includes a series of product candidates in Phase II development. Enrollment in the Company’s studies significantly slowed during the pandemic, due to trial suspensions and the decrease in eligible patient admissions to medical centers across the country. While enrollment of new patients was limited most of the year, the Company ensured that patients already entered into a trial continued to receive their study drug. Cumberland looks forward to an improvement in study enrollment as the pandemic subsides and centers begin to reopen.
The Company has Phase II clinical programs underway evaluating its ifetroban product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis, and Aspirin-Exacerbated Respiratory Disease.
FINANCIAL RESULTS:
Net Revenue: For the three months ended December 31, 2020, net revenues were $10.3 million, up 10% from $9.3 million for the prior year period. The company also recorded an additional $900,000 in revenue during the fourth quarter associated with divested product rights.
Net revenue by product for the three months ended December 31, 2020, included $5.2 million for Kristalose, $2.3 million for Vibativ, $1.7 million for Caldolor, and $0.9 million for the Company’s newest brand, RediTrex.
For the year ended December 31, 2020, net revenues were $37.4 million, an 8.9% increase compared to $34.4 million for the year ended December 31, 2019. Additionally, the company recorded a total of $3.2 million in revenue during 2020 associated with divested product rights.
Net revenue by product for the year ended December 31, 2020, included $15.6 million for Kristalose, $10.9 million for Vibativ, $5.3 million for Caldolor, $1.9 million for Acetadote (including the brand and Company’s Authorized Generic), $1.1 million for Vaprisol, $0.9 million for RediTrex, and $0.3 million for Omeclamox- Pak.
Operating Expenses: Total operating expenses for the three months ended December 31, 2020 were $12.0 million, down from $12.7 million for the prior year period. Total operating expenses for the year ended December 31, 2020 were $43.8 million, similar to $43.7 million for 2019.
Adjusted Earnings: Adjusted Earnings for the three months ended December 31, 2020 were $0.2 million, or $0.01 per share, compared to a loss of $(1.9) million, or $(0.12) per share for the prior year period. Adjusted Earnings for the full year ended December 31, 2020 were a loss of $(0.1) million, or $(0.01) per share, a significant turnaround over the loss of $(3.4) million, or $(0.22) per share in 2019.
This performance measure represents net income attributable to common shareholders with adjustments for the impact of income taxes, depreciation, amortization, share based compensation expenses and expenses that are non-core to the operating performance of the period. The definition and the reconciliation of Adjusted Earnings are provided in this release.
Cash Flow: Cash flow from operations for the year ended December 31, 2020 was $5.4 million, compared to $3.1 million for the prior year.
Balance Sheet: At December 31, 2020, Cumberland had $24.8 million in cash and cash equivalents. Total assets at December 31, 2020 were $96.5 million. Total Liabilities were $49.6 million, including $15.0 million outstanding on the Company’s revolving line of credit and $8.2 million related to contingent liabilities related to the Vibativ acquisition, resulting in Total Shareholder’s Equity of $47 million.
Conference Call and Webcast
A conference call and live Internet webcast will be held on Tuesday, March 9, 2021 at 4:30 p.m. Eastern Time to discuss the Company’s fourth quarter and annual 2020 financial results. To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 7005878. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source