Saint Laurent, Quebec--(Newsfile Corp. - August 8, 2013) - IntelGenx Technologies Corp. (TSX-V: IGX) (OTCQX: IGXT) (“IntelGenx”) today announced financial results for the three and six months ended June 30, 2013 and provided an update on operational developments. All amounts are in U.S. dollars, unless otherwise stated.
“I am very pleased to report that increased revenue, together with a reduction in costs, enabled us to record our first-ever quarterly profit” stated Dr. Horst G. Zerbe, President and CEO of IntelGenx. “During the quarter we received notification from the FDA that our NDA submission for our anti-migraine VersaFilm™ product had been accepted for review, with an FDA-assigned PDUFA date of February 3, 2014. Also, shortly after the end of the quarter we announced the filing of an ANDA for approval of a generic formulation of buprenorphine and naloxone Sublingual Film, indicated for maintenance treatment of opioid dependence.”
Corporate Development Update
ANDA for Buprenorphine/Naloxone Sublingual Film Product for the Treatment of Opiate Addiction:
Subsequent to the end of the quarter, on July 22, 2013 we announced that an Abbreviated New Drug Application (“ANDA”) has been submitted to the U.S. Food and Drug Administration (“FDA”) for approval of a generic formulation of buprenorphine and naloxone Sublingual Film, indicated for maintenance treatment of opioid dependence. The ANDA was filed by our U.S. based co-development and commercialization partner for this product. The reference listed drug is Suboxone® (buprenorphine and naloxone) Sublingual Film.
According to IMS Health, U.S. retail sales of Suboxone® Sublingual Film were approximately $1.5 billion in 2012.
In accordance with confidentiality clauses contained in the co-development and commercialization agreement, the specifics of the product description and financial terms remain confidential. We will receive a share of the profits of commercialization, in addition to upfront and milestone payments.
The FDA approved Suboxone® in October of 2002 for use in the treatment of opioid addiction. Suboxone® is a registered trademark of Reckitt Benckiser Pharmaceuticals. Suboxone® contains the two active ingredients: buprenorphine and naloxone.
NDA for Anti-Migraine VersaFilm™ Oral Film Product:
On June 18, 2013 we announced that the FDA has assigned a Prescription Drug User Fee Act ("PDUFA") action date of February 3, 2014 for the review of the our New Drug Application ("NDA") for the marketing approval of our anti-migraine VersaFilm™ oral film product. We had previously announced that, together with our co-development partner RedHill Biopharma Ltd ("RedHill"), we had submitted a 505(b)(2) NDA to the FDA for a novel, oral thin-film formulation, based on our proprietary VersaFilm™ technology containing Rizatriptan, the active drug in Merck & Co ("Merck") Maxalt-MLT® orally disintegrating tablets. According to Merck's most recent annual report, sales of Maxalt® were $638 million in 2012. The FDA confirmed that our application is sufficiently complete to permit a substantive review in accordance with the FDA's "standard" classification process.
Cash and cash equivalents improved to $2.3 million as at June 30, 2013 compared with $2.1 million as at December 31, 2012. In the second quarter of 2013 we received $0.6 million from the exercise of warrants and stock options, which was partly offset with cash used by operating activities of $0.3 million, cash used in investing activities of $0.1 million and the effect of foreign exchange on cash of $0.1 million.
Revenue of $0.7 million in the first six months of 2013 represents a significant increase compared with $0.1 million in the same period of the previous year and consisted of $0.5 million related to the achievement of development milestones for our anti-migraine and opiate addiction products, together with $0.1 million of royalty income and $0.1 million of deferred license revenue, both related to Forfivo XL®. Revenue of $0.5 million was recorded in the second quarter of 2013, compared with $0.0 million in the second quarter of 2012.
Total expenses decreased from $1.3 million in the first half of 2012 to $1.1 million in the first half of 2013. The decrease relates primarily to clinical study costs incurred in the first half of 2012 that were not repeated in 2013, together with the reversal of costs accrued in 2012 for the technical transfer of activities in preparation for manufacturing of Forfivo XL®, partly offset by increased staff costs. Total expenses decreased from $0.7 million in the second quarter of 2012 to $0.5 million in the second quarter of 2013.
The net loss decreased from $1.2 million in the first six months of 2012 to $0.4 million in the first six months of 2013, representing an improvement of $0.8 million, or 67%. In the second quarter of 2013 we recorded a net profit of $90 thousand, compared with a net loss of $630 thousand in the same period of the previous year. Although we had a profitable second quarter, we do not anticipate that we will be consistently profitable for the foreseeable future.
The loss per share improved from $0.02 in the first half of 2012 to $0.01 in the first half of 2013. In the three months ended June 30, 2013 the profit / loss per share was $0.00, compared with a loss per share of $0.01 in the same period of 2012.
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' development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. 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, 2012, 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 OTCQX 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