On March 8, 2022 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company reported full year 2021 financial results and provided a company update (Press release, Cumberland Pharmaceuticals, MAR 8, 2022, View Source [SID1234609741]). Net revenues totaled $36 million, resulting in $6 million in cash flow from operations.
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As of December 31, 2021, the company’s total assets were $84 million, including $27 million in cash. Total liabilities were $42 million, including $15 million on its credit facility and total shareholders’ equity was $43 million.
"Despite the continued challenges of operating during a pandemic, our diversified product portfolio of FDA-approved brands has helped mitigate its negative effects and allowed us to deliver another steady performance in 2021," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "We closed out the year announcing our acquisition of Sancuso, an oncology-support drug that we believe will be favorable to our financial performance and provide significant benefits to oncology patients being treated for their cancers. We look forward to the year ahead and welcome the return to a more traditional operating environment."
Cumberland acquired the U.S rights to Sancuso from the U.S. subsidiary of Kyowa Kirin, a specialty pharmaceutical company based in Japan. Sancuso is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in cancer 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.
In the fourth quarter of 2021, Cumberland extended its bank line of credit for a new three-year term and expanded the facility to provide up to $20 million in capital to fund the Sancuso acquisition.
In November 2021, Cumberland received FDA approval of expanded labeling for its Caldolor product. The intravenously delivered formulation of ibuprofen is now approved for use prior to surgery. Orthopedic surgeon Dr. Stephen Southworth, who has published extensively on intravenous ibuprofen, supported this development stating that "when administered immediately prior to surgery, patients given Caldolor experience less postoperative pain and a decrease in their opioid use."
Also during 2021, Cumberland implemented the national launch of RediTrex, its FDA-approved line of injectable methotrexate products. RediTrex features an innovative delivery system for easy handling and dosing accuracy. It is approved for patients with severe, active rheumatoid arthritis and polyarticular juvenile idiopathic arthritis who have difficulty tolerating or responding to orally delivered methotrexate.
Other highlights from the year:
Cumberland signed an agreement with Verity Pharmaceuticals to license and commercialize Vibativ in Puerto Rico. Verity has a strong presence in Puerto Rico, which is in need of a product with Vibativ’s features, as it has a large number of residents living with chronic diseases, like diabetes, that increase the risk of hospitalization and infections. 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 infections.
SciClone Pharmaceuticals, which has licensed Cumberland’s Vibativ product for China, submitted an application for the product’s approval in that market in early 2021. In September, the submission was accepted for review, which is expected to occur over a 12-month period.
Enrollment in Cumberland’s clinical studies resumed after interruption due to the pandemic. Cumberland is sponsoring three Phase II clinical programs evaluating its ifetroban product candidates. These studies involve patients with cardiomyopathy associated with 1) Duchenne Muscular Dystrophy, a fatal, genetic neuromuscular disease; 2) Systemic Sclerosis, a debilitating autoimmune disorder; and 3) Aspirin-Exacerbated Respiratory Disease, a severe form of asthma.
Cumberland issued its second annual Sustainability Report, which details the company’s activities pertaining to its environmental, social and governance matters. The 2020 Sustainability Report notes that Cumberland provided nearly 2.5 million patient doses of its products, safely disposed of over 4,000 pounds of expired and damaged products, and had no product recalls. Cumberland also had no company brands listed on the FDA’s MedWatch Safety Alerts for Human Medical Products, no company product issues identified by FDA from its Adverse Event Reporting System and no clinical trials terminated due to failure to practice good clinical standards.
The 2020 Sustainability Report also highlights several initiatives Cumberland implemented as part of its commitment to delivering high-quality pharmaceutical products to improve patient care. For example, the company continued a program to serialize all commercial products sold in the U.S., allowing it to track every unit distributed, which helps to prevent counterfeit drugs from entering the market under the Cumberland brand.
The company also announced its upcoming move to the new Broadwest campus in Nashville’s West End/Vanderbilt corridor. The new location will keep Cumberland close to the internationally recognized Vanderbilt Medical Center, with whom it regularly collaborates. It will also provide Cumberland a long-term home with increased efficiency and convenience for its overall operations.
Cumberland also announced several publications in support of its products as well as a series of patient case studies outlining real-world instances in which Vibativ was used to effectively and safely treat COVID-19 patients.
FINANCIAL RESULTS:
Net Revenue: For the three months ended December 31, 2021, net revenues from continuing operations were $8.3 million. The company also recorded an additional $0.5 million in revenue during the fourth quarter associated with divested rights to products that the company no longer distributes.
Annual net revenues were $36 million, with an additional $2 million in revenue associated with divested product rights.
Net revenue by product for the fourth quarter of 2021 included $3.7 million for Kristalose, $2.9 million for Vibativ, $1.2 million for Caldolor, $0.2 million for Acetadote, $0.1 million for Omeclamox, $0.1 million for RediTrex and a break-even point for Vaprisol.
Annual net revenue by product included $16 million for Kristalose, $11.7 million for Vibativ, $5 million for Caldolor, $1.9 million for Vaprisol, $0.9 million for Acetadote, $0.1 million for RediTrex and Omeclamox reporting current year deductions over sales.
Operating Expenses: Total operating expenses for the fourth quarter were $12.7 million and $43.7 million for the full year 2021.
Adjusted Earnings: Adjusted earnings for the fourth quarter of 2021 were $(1.9) million compared to a net loss of $(4.4) million. For the full year, adjusted earnings were $(1.2) million, or $(0.08) per share compared to a net loss of $(5.6) million, or $(0.37) per share.
The annual 2021 adjusted earnings calculation does not include the benefit of the $2 million in payments received for the two products returned. It also does not include the benefit of the $3.4 million of Vibativ cost of goods associated with sales of the product during the year, which was received with the product acquisition. Cumberland recorded an additional $1.1 million in a one-time write-off of expired inventory, also received as part of the acquisition.
Cash Flow: Cash flow from operations for the year ended December 31, 2021 was $6.3 million.
Balance Sheet: At December 31, 2021, Cumberland had $84 million in total assets, including $27 million in cash and cash equivalents. Total liabilities were $42 million, including $15 million outstanding on the company’s revolving line of credit. Total shareholders’ equity was $43 million.
CONFERENCE CALL & WEBCAST
A conference call and live Internet webcast will be held today March 8, 2022 at 4:30 p.m. Eastern Time to discuss the 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 1497637. Both the live webcast and rebroadcast can be accessed via Cumberland’s website at View Source