CV Sciences, Inc., a manufacturer of cannabidiol (CBD) products, reported last week that sales for 2015 grew to US$11.5 million from $10.2 million in the previous year.
CV Sciences (OTCBB: CANV) reported an annual net loss of $12.2 million, or 35 cents per share (basic and diluted), which compared to a net loss of $1.3 million or 4 cents per share for the year ended Dec. 31, 2014.
As of Dec. 31, 2015, CV Sciences increased its distribution of branded products to 340 retail locations, said Michael Mona, Jr., chairman and CEO of CV Sciences, in an April 15 press release. Last year, the company began marketing to the natural products sales channel in the United States, Mona said.
CV Sciences—formerly known as CannaVest Corp.—has expanded its business beyond targeting such markets as nutraceuticals, beauty care and specialty foods.
In late December, CannaVest acquired CanX, Inc., a Florida-based drug development company. CV Sciences described the acquired business in a regulatory filing as “a development stage, specialty pharmaceutical company developing synthetic cannabinoids to treat a range of medical conditions."
The company said it will need $1.5 million in additional capital over the next 12 months to support its pharmaceutical business segment, and anticipates that it will be able to secure financing on terms that are acceptable.
To date, FDA hasn’t approved CBD as a drug for commercial sale in the United States, though London-based GW Pharmaceuticals plc has been conducting clinical drug trials in hopes of winning FDA approval for its drugs Sativex and Epidiolex.
CV Sciences said it wants to file with FDA an investigational new drug application in the future.
“We expect to meet with the FDA during 2016 to determine the extent of any further required preclinical work prior to commencement of a clinical program," CV Sciences said in its annual regulatory filing. “The company’s product candidates are based on proprietary formulations, processes and technology that we believe are patent-protectable, and we plan to vigorously pursue patent protection on the company’s two drug candidates."
CV Sciences is a wholesale producer of hemp-derived CBD products, which have been widely marketed in the United States in recent years as dietary supplements. The company also sells consumer products containing plant-based CBD under its PlusCBD brand in various market sectors, including beauty care, specialty foods, vape and nutraceutical.
“There are numerous CBD-based consumer product companies, many of which are under-capitalized which we consider to be viable acquisition targets," the company said in its regulatory filing. “We routinely evaluate opportunities to purchase existing product lines, sources of CBD and other assets from certain competing companies."
FDA has taken the position that CBD products are excluded from the definition of a dietary supplement because CBD is the subject of substantial clinical investigations—namely GW’s drug trials—that have been made public.
CV Sciences and others have disagreed with FDA’s position, and the agency hasn’t taken enforcement actions against the CBD industry beyond issuing warning letters to several CBD marketers for making claims that their products can treat various medical conditions.
CV Sciences has been sourcing industrial hemp from Europe, but the 2014 Farm Bill paved the way for farmers to grow hemp in the United States through agricultural pilot programs. Last year, CV Sciences entered an agreement with the Kentucky State Department of Agriculture to complete research under pilot studies with farmers and processors of CBD. The company also entered a pact with the University of Kentucky to fund CBD-related research.