Message from CEO

To our Shareholders, Employees and Partners:

Over the past several years, we have transformed Cumberland through a series of successful business development initiatives. By design we are a very different company today than we were just few years ago. We aim to maximize the potential of our existing brands while building a portfolio of differentiated products.
 
I am very pleased to share series of important new accomplishments as we pursue our goals.
 
Cumberland recently announced the acquisition of Vibativ® from Theravance Biopharma. It’s a patented, FDA approved anti-infective injectable product, designed to treat certain serious bacterial infections - including hospital-acquired pneumonia and complicated skin infections. Vibativ addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant such as MRSA.
 
Meanwhile, we have also completed and submitted the application for the approval of our RediTrexTM product line. The submission follows a series of meetings with the FDA and we now await their determination of its completeness and their acceptance of the application for review.
 
We have also responded to the FDA on the approval request for our Next Generation Caldolor® product featuring an improved package and formulation. Earlier this year we submitted the approval application and, last quarter, we received a complete response from the FDA indicating the need for additional information. Our colleagues acted quickly and held a teleconference with the FDA to discuss the additional requirements. We then promptly filed an amendment to our application that contained the requested quality and nonclinical data. We now await the FDA's approval decision, as we prepare for the manufacture and launch of this new Caldolor product.
 
We recently announced several favorable study publications for Caldolor® and Ethyol®, adding to the growing library of literature supporting the brands. We also continued to advance our ifetroban clinical programs during the third quarter and completed enrollment in our Portaban®  Phase II clinical study. An initial review of the data from the study shows ifetroban was safe and well tolerated with no unexpected safety findings, and a full analysis of the data is ongoing. We will now await results from our other Phase II ifetroban studies before deciding on the best path for approval of our first new chemical entity.
 
To develop new medicines for the future we are developing a pipeline of new product candidates at CET, our R&D initiative. During the third quarter, the U.S. National Cancer Institute awarded $2 million in support of a joint research program involving Cumberland, CET, and Vanderbilt University. The objective of the research program is to further develop a novel small molecule radiosensitizing agent designed to enhance the treatment of certain lung cancers.
 
During the third quarter our net revenues were $8.5 million and Adjusted Earnings were $(0.8) million, or $(0.05) per share. We also continued to maintain a strong financial position with $87 million in total assets and approximately in $48 million in cash and investments. I’d like to thank everyone at Cumberland for their hard work and contributions so far this year. We remain focused on our mission of advancing patient care through the delivery of high quality pharmaceutical products. We will be sure to keep you updated on our progress as we work towards a strong finish to 2018.
 
 
With best wishes,


A.J. Kazimi
Chief Executive Officer
November 2018