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| Statement |
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| We're pleased to see that Vibativ sales continue to improve and were up 18% in 2023, reflecting the several new initiatives underway to improve the brand's performance |
| In fact, Vibativ sales rebounded in 2023, with the brand beginning to deliver an attractive return on the investment associated with its acquisition |
| Kristalose continues to be our largest selling product and is benefiting nicely from the support of our two co-promotion partners, with 2023 sales up 5% over the prior year |
| It's been particularly encouraging to see the recent growth in our Kristalose business, along with the rebound in Vibativ sales |
| Throughout the year, we continued to work with our partners in their efforts to register and launch Vibativ in several international markets, which can provide significant catalysts for the brands in the future |
| We're excited about the expansion of our oncology sales division and the opportunity to further help cancer patients |
| Overall, it was a good year, and we are encouraged by the developments that we've shared with you today |
| We're pleased to share the recent pediatric studies involving favorable results for both Vibativ and Caldolor in children, as well as FDA's approval of the expanded labeling for Caldolor to now include infants |
| We are already seeing a favorable impact from this expanded sales division, which we plan to build upon to increase customer frequency and reach in 2024 |
| Our balance sheet also remained strong as we ended the year with $82 million in total assets, including $20 million in cash, $53 million in liabilities, and $30 million of shareholders' equity |
| Moreover, we found that the brand performs best in states where we have Medicaid coverage |
| We're very pleased to have further expanded the product labeling for use in patients of nearly all ages and have launched a marketing initiative highlighting this new indication |
| In 2023, we also shared the positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in newborns |
| In many ways, 2023 was a productive and important year for Cumberland, as we were able to take key steps in laying the foundation for future success |
| Now, I'm pleased to share a series of exciting developments which occurred in 2023, including several growth opportunities for our brands |
| We continued to integrate our newest products while also delivering a number of significant achievements, which we'll recap on today's call |
| We continue to progress our pipeline of innovative products designed to improve patient care and patients' quality of life |
| With that in mind, I'm pleased to report that net revenue for the full year 2023 were $40 million |
| It's now been dosed in nearly 1,400 subjects and has been found to be safe and well tolerated in those individuals |
| Our mission is now working together to provide unique products that improve the quality of patient care |
| Meanwhile, Kristalose, Caldolor, and Vibativ continued their steady contributions to our revenue mix |
| The results of the study, which were published in the Journal Pediatric Drugs, supports 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, children, and adults |
| We believe that this new coverage is contributing to the growth of the product |
| Our gross margins remained attractive in 2023, resulting in $6 million in cash generated from operations for the year |
| rights to the brand in 2022, we successfully completed the transition from Kyowa Kirin to Cumberland in 2023, which included the NDA transfer |
| We also successfully transferred manufacturing of the product to a new facility |
| And we believe the special reimbursement associated with the Federal No Pain Act can have a meaningful impact on Caldolor's future growth |
| We have updated our metrics, and today I'm pleased to announce the key findings for 2023, which include providing 3 million doses of our products to patients, safely disposing of nearly 6,000 pounds of damaged and expired product, and having no products recalled and no clinical trials terminated due to failure to practice good clinical standards |
| We remain committed to fulfilling this mission by building a portfolio of specialty pharmaceutical brands, which we do by maximizing the potential of our commercial brands, progressing our pipeline, and also pursuing select acquisitions |
| For the three months ended December 31, 2023, net revenue from continuing operations were $9.4 million, an increase over the $9.1 million in revenue recorded during the prior year period |
| Statement |
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| I'd like to note that 2023 Sancuso net sales were significantly lower than those we experienced in the prior year due to an inordinate amount of sales deductions |
| Antimicrobial resistance continues to pose a significant challenge in the treatment of bacterial infections, necessitating the development of new antibiotic therapies |
| The net loss for the quarter and the year was approximately $6.3 million, which includes a $3.3 million one-time write-down of Omeclamox in tangible assets |
| There are many factors that could affect Cumberland's future results, including natural disasters, economic downturns, public health epidemics, international conflicts and others that are beyond the company's control |
| Despite the company's best efforts, actual results may differ materially from expectations |
| It's a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal heart and lung muscles |
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