This FIGHTING FIBROSIS study is designed to enroll 128 patients in over 20 medical centers of excellence across the United States. And recent studies have shown that ifetroban can help both prevent and enhance resolution of lung fibrosis in multiple preclinical models. Meanwhile, patient enrollment is already well underway in our other two company-sponsored Phase II clinical programs. The first involves patients with systemic sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs. And the other study is evaluating ifetroban in patients with a cardiomyopathy associated with Duchenne Muscular Dystrophy, or DMD, a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles.
We’re sponsoring that FIGHT DMD trial, which is a multicenter, randomized, placebo-controlled Phase II study, which is actively enrolling patients across 10 centers in the United States with those centers specializing in DMD. Also note, we’ve received over $1 million now in grant awards from the FDA to support this study. Enrollment in the younger patient group is complete, and we’re now working to finish enrollment in the older patient cohort of this study. In addition to these company-sponsored studies, there are several other preclinical and pilot studies of ifetroban underway, including several investigator-initiated trials. We do expect to have data available this year, and we look forward to them sharing the results from these studies underway as they emerge and then deciding on the best path for ifetroban, the best development path for ifetroban, which we believe has the potential to benefit many patients.
So with that update on our clinical studies, I’d now like to turn it over to our Chief Financial Officer, John Hamm, to review our first quarter financial results. John?
John Hamm: Thank you, A.J. For the three months ended March 31, 2024, net revenue from continuing operations were $8.5 million. Net revenue by product for the first quarter of 2024 included $3.2 million for Kristalose; $1.8 million for Sancuso; $1.6 million for Vibativ and $1.5 million for Caldolor. Turning to our expenditures. Total operating expenses for the first quarter were $10.4 million. Net loss for the quarter was $1.9 million and when the noncash expenses are added back, the resolving loss was $0.6 million. Also, please note that the adjusted earnings calculations do not include the additional benefit of the $0.5 million of Vibativ and Sancuso cost of goods during the first quarter. Those goods were received as part of each product’s acquisition.
As a reminder, the additions of Vibativ and Sancuso to our product portfolio continue to positively impact our financial statements. As a result of the Vibativ acquisition, a total of $34 million in new assets were added, including approximately $21 million in inventory, $12 million of intangible assets and $1 million of goodwill. The financial terms for the Vibativ transaction included a $20 million payment upon closing and a subsequent $5 million milestone payment. We also continue to provide royalties tied to product sales. Vibativ was our largest acquisition, and I’m pleased to report that since we assume responsibility for the product in late 2018, it has delivered a total cash contribution of $39 million to our business and therefore, is generating return on our $25 million investment.
Sancuso added a total of $19 million in new assets, including $4 million in inventory and $14 million of intangibles. The estimated value of those assets was $12 million at the end of the first quarter. We provided $13.5 million at closing for the Sancuso acquisition, and we also paid $1.5 million in milestone payments. There are ongoing royalties that we pay based on the brand sales. Since we started shipping Sancuso in early 2022, the product has provided a total cash contribution of approximately $14.8 million and therefore, is expected to begin generating return on our $15 million investment this year. Turning to our balance sheet as of March 31, 2024, we had $82 million in total assets, including $19 million in cash and cash equivalents.
Liabilities totaled $54 million, including $16 million on our credit facility. Total shareholders’ equity was $27 million at the end of the quarter. We continue to hold a bank line of credit, which holds up to $20 million in capital and provides the ability for Cumberland to increase the amount of $25 million under certain conditions. The interest rate is based on benchmark term SOFR and is subject to one financial covenant to determine on a quarterly basis. During the first quarter, we continued our corporate share repurchase program buying a total of 126,000 shares. These repurchases included those on the open market and those needed to fund the taxes associated with employee vested restricted shares. We are also continuing the process of implementing new trading plans for our Board members who will purchase Cumberland shares throughout the year to increase their holdings in the company.
Lastly, I’d like to note that Cumberland continues to hold over $52 million in tax net operating loss carryforwards, primarily resulting from the prior exercise of stock options. And that completes our financial report for the first quarter of 2024. Back to you, A.J.
A.J. Kazimi: Thank you, John. We recently released our 2023 annual report, which includes last year’s financial results and milestones as well as updated sustainability metrics. You can find a copy of the report on our website under the Investor Relations tab. We also recently held our Annual Shareholder Meeting. All the proposals presented in our proxy were approved, including the reappointment of Martin Brown and James Jones as Cumberland Board of Directors. Overall, it’s been a productive start to the year. We remain dedicated to our mission of working together to provide unique products that improve the quality of patient care. And we’re doing that by building the portfolio of FDA-approved brands with outstanding safety and efficacy profiles that can truly make a difference in patients’ lives.
