Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI ; OTCQX:NRIFF), a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities, today announced its financial and operational results for the fourth quarter and year ended December 31, 2017.
Fourth Quarter 2017 and Business Update
Pennsaid® 2%
U.S. prescriptions of Pennsaid 2% were 110,000 in the fourth quarter of 2017 compared to 108,000 prescriptions in the third quarter of 2017. According to IMS Health/IQVIA, for the year ended December 31, 2017, U.S. prescriptions of Pennsaid 2% were 434,000 compared to 457,000 for the year ended December 31, 2016.
In December 2017, the Company entered into a license and distribution agreement with Gebro Pharma AG (Gebro Pharma) for the exclusive right to register, distribute, market and sell Pennsaid 2% in Switzerland and Liechtenstein.
Resultz®
In January 2018, the Company's wholly owned subsidiary, Nuvo Pharmaceuticals (Ireland) Limited (Nuvo Ireland) acquired the U.S. product and intellectual property rights to Resultz from Piedmont Pharmaceuticals LLC (Piedmont). The acquisition included all U.S. product and intellectual property rights. Resultz was cleared as a Class 1 medical device by the U.S. Food and Drug Administration (FDA) in May 2017 and has not yet been commercially launched in the U.S. Nuvo anticipates commercializing Resultz in the U.S. through a licensing partner and has already initiated discussions with potential licensees.
In December 2017, the Company acquired the global, ex-U.S. product and intellectual property rights to Resultz from Piedmont. The transaction included existing royalty streams in France, Spain, Portugal, Belgium, Ireland and the United Kingdom, Canada, Russia, Australia, and Israel which are generated from a network of existing global licensees and license agreements that were assumed by Nuvo.
Corporate Developments
In November 2017, the Toronto Stock Exchange (TSX) approved the Company's notice of intention to make a normal course issuer bid for a portion of its outstanding common shares as appropriate opportunities arise from time-to-time. Pursuant to the notice, Nuvo is authorized to acquire up to a maximum of 919,819 of its common shares, or approximately 10% of the public float of 9,198,191 as of November 30, 2017, for cancellation over the next 12 months. Nuvo believes that the repurchase of a portion of outstanding common shares is an appropriate use of available cash and is in the best interest of Nuvo and its shareholders.
On November 28, 2017, the Company's common shares commenced trading on the OTCQX® market in the United States under the symbol "NRIFF". Nuvo's common shares will continue to trade on the TSX under the symbol "NRI".
In November 2017, the Board of Directors of the Company appointed Jesse Ledger to the position of President & Chief Executive Officer. Mr. Ledger had previously held the position of President. Mr. Ledger assumed the CEO role from John London who was appointed the Company's Executive Chairman and continues to serve on its Board of Directors.
Fourth Quarter and Full Year Financial Summary(1)
As previously disclosed, the Company's supply of commercial bottles of Pennsaid 2% to its U.S. partner Horizon Pharma plc (Horizon) throughout 2017 was affected by the installation of new packaging equipment to facilitate compliance with the U.S. Federal Drug Supply Chain Security Act and Horizon's plan to draw down existing inventory during the installation process. Supply of Pennsaid 2% physician samples was negatively affected by the changes Horizon made to its commercial operation in 2017.
Total revenue for the year ended December 31, 2017 was $17.5 million compared to $27.0 million for the year ended December 31, 2016. Total revenue was $4.5 million for the three months ended December 31, 2017 compared to $5.6 million for the three months ended December 31, 2016.
Adjusted EBITDA(2) decreased to $2.2 million for the year ended December 31, 2017 compared to $8.9 million in the comparative year. Adjusted EBITDA decreased to $36,...
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