Cumberland Pharmaceuticals (NASDAQ: CPIX) stock recently attained a 52 week high at $7.09, up from $4.20 from the same time in the previous year. What factors have been driving the price of CPIX? We believe that the rise in share price is reflecting the company’s improving fundamentals. Cumberland provided a series of favorable quarterly reports for 2014 delivering both growth and profitability. We also reported progress on the late stage development of two new product candidates – Heptoren® and Boxaban™. Our balance sheet has remained strong to support product additions and growth initiatives.
Cumberland was responsible for FDA approval of Acetadote® and Caldolor®. How long is the FDA approval process and how important is it?
FDA approval is key to our business. We must meet a rigorous set of criteria required by the FDA before they will approve a product. We must demonstrate a product’s safety and efficacy profile acceptable to the FDA while assuring high quality manufacture. Submitting a product for FDA approval is the culmination of a lengthy process involving extensive non-clinical and patient studies, data analysis and biopharmaceutical manufacturing activities. We understand that our Acetadote® and Caldolor® products were the first FDA approved pharmaceuticals achieved by a Nashville based company.
We also noticed the addition of two new products, Vaprisol® and Omeclamox®-Pak to the company’s portfolio in 2014. Have they been able contribute to the overall performance of Cumberland Pharmaceuticals’ product line in the short amount of time since adding them?
We launched promotion of both products in 2014 resulting in the most diversified revenue stream in our company’s history. Both products represented a good fit with our medical specialties and commercial capabilities. We have been pleased with their initial contributions that have played an important role in our recent
financial results. We are also excited about the longer term growth prospects of both new brands.
Expansion of market share is important to any business, how do you foresee the expansion of Cumberland Pharmaceuticals, through expansion of existing product lines or, the potential acquisitions of future products?
Both. We believe that an FDA approved product is a valuable asset and we evaluate new opportunities to expand the market potential for our brands, by developing additional clinical data or by studying new patient populations that could benefit. In addition, we are also actively seeking out select acquisition candidates that would be a good fit for our company and our strategy.