Saint Laurent, Quebec--(Newsfile Corp. - March 29, 2012) - IntelGenx Technologies Corp. (TSXV: IGX) (OTCBB: IGXT) ("IntelGenx") today announced financial results for its fiscal year ended December 31, 2011 and highlights recent operational developments.
In announcing the results, Dr. Horst G. Zerbe, President and CEO of IntelGenx stated “We are extremely pleased to have ended 2011 with our strongest balance sheet ever, with $3.5 million of cash at the bank, and no debt. We further strengthened our cash position in the first quarter of 2012 through the receipt of the signing fee for the licensing agreement with Edgemont Pharmaceuticals for CPI-300, and we expect that the commercialisation of CPI-300 in the summer of 2012 will improve our cash inflows still further.” Added Dr. Zerbe, “We are also proud of our association with Par Pharmaceutical Inc., one of the largest generic companies in the United States, and although the terms of the agreement with Par continue to remain confidential, we are making excellent progress with this project. At the same time, we continue to work diligently towards the execution of additional collaboration agreements as we move through 2012 in what we believe will be a defining year for IntelGenx”.
Recent Operational Developments and Upcoming Events:
CPI-300 Antidepressant Tablet:
Following dismissal by the United States District Court of Delaware of the patent infringement action brought forward by Biovail, IntelGenx resubmitted its New Drug Application (“NDA”) 505(b)(2) in response to the Complete Response Letter received from the U.S. Food and Drug Administration (“FDA”). Subsequently, in November 2011, the FDA approved CPI-300 for patients with Major Depressive Disorder.
In February 2012 IntelGenx entered into an exclusive agreement with Edgemont Pharmaceuticals, LLC (“Edgemont”) for the commercialization of CPI-300, in the United States. Under the terms of the agreement, Edgemont has obtained exclusive rights to market and sell CPI-300 in the United States and, in exchange, IntelGenx received an upfront payment of $1 million, and could receive launch related milestone payments totaling up to another $4.0 million. In addition, IntelGenx is eligible for additional milestone payments upon achieving certain sales and exclusivity targets of up to a further $23.5 million, together with tiered royalties (double digit) on the net sales of CPI-300.
Commercial sales of CPI-300 are expected to commence in the summer of 2012.
By coincidence, a Dr. Robert L. Zerbe, MD, serves on the Edgemont Board of Directors. Both Dr. Robert L. Zerbe and Dr. Horst G. Zerbe, President, CEO and Chairman of the Board of Directors of IntelGenx Technologies Corp., have stated that they have no relation to each other.
CPI-300 is a higher strength of the antidepressant bupropion HCl, the active ingredient in Wellbutrin XL®.
Development and Commercialization Agreement with Par Pharmaceutical, Inc.:
In December 2011 IntelGenx announced the execution of a co-development and commercialization agreement with Par Pharmaceutical, Inc. ("Par") for a new product utilizing one of IntelGenx’ proprietary oral drug delivery platforms. For commercial reasons, and in order to protect both Par’s and IntelGenx’ competitive advantage, the agreement stipulates that all information pertaining to the product, together with financial terms of the agreement, are to remain confidential.
IntelGenx ended fiscal 2011 with approximately $3.5 million in cash and cash equivalents, compared with $1.1 million as at the end of fiscal 2010. The balance at December 31, 2011 includes approximately $2.9 million of net proceeds received from the private placements that closed on June 21, 2011 and approximately $1.9 million received from the exercise of warrants and stock options that were exercised primarily during the second half of fiscal 2011.
Revenue declined from $0.9 million in fiscal 2010 to $0.4 million in 2011. The decrease relates primarily to a decline in revenue earned from our pharmaceutical partners for development milestones achieved, including non-refundable upfront license fees, which were $0.4 million in the year ended December 31, 2011 compared with $0.7 million in the previous year.
Total expenses declined from $4.4 million in fiscal 2010 to $2.9 million in 2011, representing an improvement of 34%, or $1.5 million. The decrease in total expenses is primarily attributable to the dismissal in February 2011 of the patent infringement lawsuit that was initiated against us by Biovail in August 2009. Dismissal of the lawsuit resulted in a decrease of approximately $1.0 million dollars compared with the previous year. Other reductions in expenses include a decrease in R&D expenses of approximately $0.2 million related to the timing of research and development project milestones, a decrease in management salaries of approximately $0.2 million primarily related to reduced consultancy expenses within business development, and a decrease in interest and financing fees of approximately $0.1 million related to the restatement of the exercise price of the warrants issued with respect to the convertible notes transaction on May 22, 2007.
The net loss improved by 19% from a loss of $3.1 million in fiscal 2010 to a loss of $2.5 million in 2011, and the loss per share improved by 38% from a loss of $0.08 per share in 2010 to a loss of $0.05 per share in 2011.
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' research and development pipeline includes products for the treatment of severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, bipolar disorder, idiopathic pulmonary fibrosis, allergies and pain management. More information is available about the company at www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx' operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx' plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx' actual results could differ materially from those expressed or implied by these forward looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx' annual report on Form 10-K for the fiscal year ended December 31, 2011, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities and www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
Each of the TSX Venture Exchange and OTC Bulletin Board has neither approved nor disapproved the contents of this press release.
Dr. Horst G. Zerbe,
President and CEO
IntelGenx Technologies Corp.
T: +1 514-331-7440 (ext. 201)
F: +1 514-331-0436