Meanwhile, we’re planning to provide interim supplies of a special compounded conivaptan product to the market in support of critically ill patients. The companies will share in the sales of this interim compounded product, which is expected to be available in the coming months. We then expect to file for the approval to manufacture branded Vaprisol once all FDA issues at this new site are resolved. That completes my updates for today, and I’ll turn it back over to you, A.J.
A. J. Kazimi: Thank you, Todd. Before we turn to the financial report, I’d like to provide an update on our ongoing clinical pipeline. Throughout the third quarter, we continued to progress our Phase II clinical trials evaluating ifetroban, a potent and selective thromboxane receptor antagonist for patients with a series of unmet medical needs. It has now been dosed in nearly 1,400 subjects and is found to be safe and well tolerated in those individuals. Patient enrollment is well underway in two company-sponsored Phase II clinical programs. One is evaluating ifetroban in systemic sclerosis or scleroderma. It’s a dehabilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs. Enrollment in that study is well underway.
The other ongoing clinical program involves the cardiomyopathy associated with Duchenne Muscular Dystrophy, or DMD. It’s a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles. We’re sponsoring the FIGHT DMD trial, a multicenter randomized placebo-controlled Phase II study enrolling patients across 10 centers in the United States that specialize in DMD. We have completed enrollment in the younger age group of patients and now are working to finish enrollment in the older patient group with DMD. Meanwhile, earlier this year, we announced that the FDA cleared the investigational new drug application for a Phase II study in patients with idiopathic pulmonary fibrosis or IPF. It’s the most common form of progressive fibrosing interstitial lung disease and as a result, we’re in the process of initiating our fighting fibrosis trial designed to enroll 128 patients and over 20 medical centers of excellence across the U.S. Recent studies have shown ifetroban can both prevent and enhance resolution of lung fibrosis in multiple preclinical models.
In addition to these sponsored studies, there are several other preclinical and pilot patient studies of ifetroban underway, including several investigator-initiated trials. Our plan going forward is to complete each of our company-sponsored studies analyzing — analyze the resulting data, announce the top line results and then decide on the best development path for the registration of ifetroban. And we continue to believe it has the potential to benefit many patients with orphan diseases that represent unmet medical needs. So with that update on our ongoing clinical trials, I’d now like to turn it over to our Chief Financial Officer, John Hamm, to review our third quarter financial results. John?
John Hamm: Thank you, A.J. For the three months ended September 30, 2023, net revenue from continuing operations were $10.1 million. Net revenue by product for the third quarter of 2023 included $3.9 million for Kristalose; $2.8 million for Vibativ, $1.9 million for Sancuso and $1.2 million for Caldolor. Total year-to-date net revenue were $30.2 million, including $12.3 million for Kristalose, $6.8 million for Vibativ, $5.7 million for Sancuso and $3.3 million for Caldolor. Each of these brands has experienced growth in sales this year with the exception of Sancuso. Unfortunately, the brand has seen sales deductions associated with the product transition. We are working to address these issues and believe over time, Sancuso performance will improve, and therefore, it’s best evaluated on an annual basis.
Turning to our expenditures. Total operating expenses for the third quarter were $12 million, slightly more than the $11.7 million for the prior year period. Year-to-date expenses totaled $33.6 million. Net loss for the third quarter was $1 million, and when the noncash expenses are added back, the resulting adjusted earnings were $260,000 or $0.02 a share. The year-to-date adjusted earnings were $4.2 million or $0.29 a share. Both net income and adjusted earnings have improved significantly over the last year. Also, please note that the adjusted earnings calculation do not include the additional benefit of the $0.8 million cost of goods for Vibativ and Sancuso during the quarter. Year-to-date, the benefit is $1.7 million. That inventory was received as part of each product’s acquisition.
The total cash flow from operations was $5.1 million. As a reminder, the additions of Vibativ and Sancuso to our product portfolio have continued to significantly 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 in a subsequent $5 million milestone payment. We also continue to provide royalties tied to product sales. Vibativ was our largest acquisition, and I am pleased to report that since we assume responsibility for the product in late 2018, it has delivered a total cash contribution of $37.2 million to our business and therefore is now generating a return on our $25 million investment.
