On March 7, 2023 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company reported full year 2022 financial results and provided a Company update (Press release, Cumberland Pharmaceuticals, MAR 7, 2023, View Source [SID1234628286]). Net revenues grew 17% over the prior year to $42 million, resulting in $8 million in cash flow from operations.
As of December 31, 2022, the Company’s total assets were $93 million, including $20 million in cash. Total liabilities were $57 million and total shareholders’ equity was $36 million.
"We were able to manage our business in 2022 to deliver significant revenue growth despite facing external challenges in our operating environment," said A.J. Kazimi, Cumberland Pharmaceuticals CEO. "We were delighted to add and begin providing Sancuso in support of oncology patients, as we further expanded our portfolio of FDA-approved brands."
HIGHLIGHTS FOR THE YEAR INCLUDE:
New Headquarter Office Location
In the fourth quarter of 2022, Cumberland relocated its headquarters to the Broadwest campus in the Vanderbilt/West End corridor of Nashville. The new, state-of-the-art headquarters keeps the Company close to Vanderbilt University Medical Center, enabling their continued collaboration as Cumberland works to develop new medicines for the future.
The move also allows Cumberland to accommodate recent and future growth. Following the relocation, Cumberland expects to expand its organization to over 100 individuals, with a majority working from the Nashville headquarters. The move will help to support the Cumberland team, its patients, customers and partners.
2022 Sustainability Metrics
Cumberland continues to monitor and report on its activities and impact on the environmental, its employees and the community. The Company’s key sustainability metrics for 2022 include:
•Providing 2.2 million doses of products to patients
•Safely disposing of over 2,750 pounds of expired or damaged products
•No products recalled or clinical trial terminated due to a failure to practice good clinical standards.
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Sancuso Acquisition
During 2022, Cumberland acquired and successfully completed the transition of Sancuso from Japan-based Kyowa Kirin, Inc. – assuming responsibility for the brand’s sales, distribution and promotion in the U.S. Sancuso is an FDA-approved prescription patch that prevents nausea and vomiting in patients undergoing certain types of chemotherapy.
To promote and support Sancuso, Cumberland formed a new sales division, Cumberland Oncology, comprised of former Kyowa Kirin sales representatives who brought extensive experience with the brand.
Caldolor International Update
In 2022, Cumberland announced its agreement with PiSA Pharmaceutical for the registration and commercialization of Caldolor, its non-narcotic pain relief product, in Mexico.
Under the terms of the agreement, Cumberland will be responsible for providing the product dossier and supplies. PiSA will be responsible for obtaining regulatory approval for the product in Mexico and introducing it to the new market.
Vibativ International Updates
In March 2022, Cumberland announced the launch of Vibativ in Puerto Rico. The announcement follows an agreement between Cumberland and Verity Pharmaceuticals that provides Verity the rights to introduce the product for patients in that market. 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 can serve as a potentially life-saving treatment in patients with hospital-acquired and ventilator-associated pneumonia resulting from infections including the flu and COVID-19.
Cumberland also announced a new partnership with Saudi Arabia-based Tabuk Pharmaceutical to introduce Vibativ into the Middle East. The arrangement provides Tabuk exclusive rights and obligations to distribute Vibativ in Saudi Arabia and Jordan, with the option to expand into other countries in the region. Tabuk is a fully owned subsidiary of the Astra Industrial Group, a leading and publicly traded conglomerate in Saudi Arabia.
In addition, Cumberland entered into an agreement with D.B. Pharm Korea to register and commercialize the Vibativ product in South Korea. The submission for approval is underway.
Cumberland’s Vibativ partner for the Chinese market, SciClone Pharmaceuticals, had their approval application in China accepted for review in September 2021. During 2022, Cumberland continued to support SciClone and their requests associated with review of that submission.
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 brand. Nordic Pharma will assume the responsibility for distributing the product in the U.S. after June 30, 2023.
In addition, Cumberland has transferred the marketing responsibilities associated with the brand to Nordic Pharma and will continue to distribute and support RediTrex during the transition period.
Ongoing Clinical Development
Cumberland continues to sponsor and progress three Phase II clinical programs featuring the Company’s ifetroban product candidate. These studies involve patients with:
•Aspirin-Exacerbated Respiratory Disease, or AERD, a severe form of asthma;
•Systemic Sclerosis, a debilitating autoimmune disorder; and
•Duchenne Muscular Dystrophy, a genetic neuromuscular disease.
In addition, Cumberland has been working toward an application to the FDA for a fourth Phase II clinical program, which will evaluate the use of ifetroban to treat patients with Progressive Fibrosing Interstitial Lung Diseases.
FINANCIAL RESULTS:
Net Revenue: In 2022, net revenues were $42.0 million, a 17% increase over the prior year. Net revenues by product for the year were $15.2 million for Kristalose, $13.2 million for Sancuso, $7.5 million for Vibativ and $4.8 million for Caldolor.
During the fourth quarter of 2022, net revenues totaled $9.1 million. Net revenue by product for the quarter included $2.4 million for Sancuso, $3.8 million for Kristalose, $1.5 million for Vibativ and $1.8 million for Caldolor.
Operating Expenses: The 2022 operating expenses were $47.7 million, compared to $43.7 million for 2021. Total operating expenses for the fourth quarter were $11.4 million compared to $12.7 million for the prior year period.
Earnings: Net loss for the fourth quarter of 2022 was $2.4 million, and $5.6 million, or $0.38 per share, for the year.
Adjusted Earnings: For the full year of 2022, adjusted earnings were $2.1 million, or $0.14 per share, a significant improvement on the adjusted loss of $1.2 million in 2021. The adjusted loss for the fourth quarter of 2022 was $0.7 million, or $0.05 per share, a significant improvement over the $1.9 million adjusted loss during the same period in 2021.
The adjusted earnings calculation does not include the $1.5 million cash benefit of Vibativ and Sancuso cost of goods during the quarter, which were received with the product acquisition. For the full year, the cash benefit from those cost of goods was $4.8 million.
Cash Flow: In 2022, cash flow from operations was $8.5 million, a 33% increase over the $6.3 million during the prior year period.
Balance Sheet: At December 31, 2022, Cumberland had $93 million in total assets, including $20 million in cash and cash equivalents. Total liabilities were $57 million, including $16 million outstanding on the Company’s revolving line of credit. Total shareholders’ equity was $36 million.
EARNINGS REPORT CALL:
Cumberland will provide its 2022 financial results via a conference call today at 4:30 p.m. Eastern Time. To join the call, register at:
https://register.vevent.com/register/BIc9d03deed82d47389284c0538fb62962.
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided. They can also choose a "Call Me" option to have the system automatically call them at the start of the conference call.
Available on Cumberland’s website for one year, a replay of the call can be accessed by visiting View Source
ABOUT CUMBERLAND PHARMACEUTICALS:
Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in the Mid-South and is focused on the delivery of high-quality, prescription brands designed to improve patient care. The Company develops, acquires, and commercializes products for the hospital acute care, gastroenterology, rheumatology and oncology market segments.
The Company’s portfolio of FDA-approved brands includes:
•Acetadote (acetylcysteine) injection, for the treatment of acetaminophen poisoning;
•Caldolor (ibuprofen) injection, for the treatment of pain and fever;
•Kristalose (lactulose) oral, a prescription laxative, for the treatment of constipation;
•Omeclamox-Pak, (omeprazole, clarithromycin, amoxicillin) oral, for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
•RediTrex (methotrexate) injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis;
•Sancuso (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;
•Vaprisol (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and
•Vibativ (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.
The Company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Aspirin-Exacerbated Respiratory Disease.
For more information on Cumberland’s approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the Company’s website at www.cumberlandpharma.com.