Message from CEO

To our Shareholders, Employees and Partners:

We have been working hard to deliver high quality medicines that improve the care for patients. We also seek to achieve sustained growth and profitability for our shareholders. Our strategy for accomplishing these two key objectives has been multi-faceted – we’ve added new brands, launched new marketing programs, increased the sales support for our products and expanded product labeling. Those efforts have strengthened our market presence and diversified our business.

I am pleased to report the completion of  our largest transaction to date, with the acquisition of Vibativ® from Theravance Biopharma. Vibativ is a patented, FDA approved anti-infective brand, designed to treat serious bacterial infections. It’s a potential lifesaving product that addresses a range of bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant such as MRSA. We believe Vibativ is a product uniquely positioned and an excellent strategic match for our hospital product infrastructure.

Net revenues in the fourth quarter of 2018 were $13.5 million, growing 16% over the prior year period, due to the initial shipments of Vibativ. Adjusted Earnings for the quarter were $1.6 million, or $.10 per share. We continued to maintain a strong financial position with total assets increasing to $113 million, including $36 million in cash and investments at the end of the year. During 2018 we expanded our bank credit line to $20 million and fully utilized that facility.

We have also made significant progress on two key regulatory initiatives. In February 2018 we submitted an application to the FDA for the approval of our Next Generation Caldolor® product. After a series of interactions with the FDA and amendments to our application, we were delighted to learn of the product’s subsequent approval! We are now preparing for the launch of this patented product, which features an improved package and formulation.

In November 2018, we completed and filed an application with the FDA requesting approval for our new methotrexate product line. We are seeking approval for the use of the products to treat rheumatoid arthritis and psoriasis. The FDA accepted the submission as complete and ready for review, providing a target approval decision date for September 2019.

Meanwhile, we continued to advance our clinical programs, which features several new product candidates in Phase II studies. We completed study enrollment for Portaban® - our Portal Hypertension clinical program. Initial review of the data from the study shows ifetroban to be safe and well tolerated with no unexpected safety findings. We continued to advance our Vasculan® and Boxaban® clinical programs as well, with patient enrollment progressing in each of those Phase II studies.

We have been establishing a pipeline of new product candidates at Cumberland Emerging Technologies (“CET”) our R&D initiative. In October of 2018, the U.S. National Cancer Institute awarded $2 million in support of a joint research program involving Cumberland, CET, and Vanderbilt University. CET also expanded its network of institutional collaborators entering into agreements associated with Louisiana State University and the Medical College of South Carolina. These arrangements expand CET’s roster of academic collaborations which also includes: Vanderbilt University, the University of Mississippi, and the University of Tennessee. These partnerships combine the strengths and capabilities of each organization by working together to identify and develop attractive new biomedical products.

I’d like to acknowledge and thank our team for all their hard work and fine efforts, We will continue to focus on sustained growth and profitability through new product introductions, marketing and product enhancements and the efficient use of our financial resources. We are confident that we have put the key pieces in place to help us to deliver on our goal to improve patient care through the delivery of high-quality pharmaceutical products.

 
 
With best wishes,


A.J. Kazimi
Chief Executive Officer
February 2019