SAINT LAURENT, QUEBEC, Mar 31, 2010 (MARKETWIRE via COMTEX) -- IntelGenx Technologies Corp. (IGX)(US:IGXT) ("IntelGenx") today reported its financial results for the fourth quarter and fiscal year ended December 31, 2009 and provided a summary of development milestones achieved. All figures are in U.S. dollars, unless otherwise stated.
FISCAL YEAR FINANCIAL HIGHLIGHTS:
Cash and cash equivalents at December 31, 2009 were approximately $1.5 million compared to approximately $0.6 million at December 31, 2008.
Gross proceeds of approximately $3.9 million were raised through private placements in 2009, compared to approximately $2.8 million in 2008.
Debt instruments totalling approximately $1.1 million were repaid in 2009.
Total revenue increased by 31%, or $0.3 million, to $1.3 million in 2009 (2008: $1.0 million).
Total expenses decreased by 15%, or $0.6 million, to $3.3 million in 2009 (2008: $3.9 million).
The net loss reduced by 31%, or $0.9 million, to $1.9 million in 2009 (2008: $2.8 million).
The loss per common share reduced by 50% to $0.07 in 2009 (2008: loss of $0.14).
Commenting on the results, Horst Zerbe, President and Chief Executive Officer of IntelGenx, said: "I am very pleased to report the progress made to our financial situation in fiscal 2009. As at the end of the year we had significantly more cash than at the end of the previous year, our balance sheet was free of long term debt and higher revenue, together with lower costs, greatly improved our income statement and halved our loss per share. We are most excited about the advances made in our pipeline and technologies. In the past year we filed an NDA for our high dose Bupropion XL product, and we received excellent data on both our Relivar product and thin film migraine product. These milestones validate our best in class VersaTab™, VersaFilm™ and AdVersa™ technologies".
Raised approximately $3.9 million in the third quarter through private placements:
In the third quarter of 2009, the Company closed three private placements for gross proceeds totaling approximately $3.9 million. The first offering of approximately 10.5 million special warrants raised gross proceeds of approximately $3.6 million. Each special warrant entitles its holder to receive, upon exercise or deemed exercise thereof, one common share of the Company and one common share purchase warrant. In the two subsequent offerings the Company issued a total of 600,000 units to investors for gross proceeds of approximately $220.4 thousand. Each unit consists of one common share of the Company and one common share purchase warrant. All of the aforementioned common share purchase warrants entitle the holder to purchase one common share at an exercise price of $0.80 per common share and expire 36 months after the date of issuance.
Debt-free balance sheet:
Repaid convertible notes outstanding:
On September 22, 2009, the Company repaid the balance of the convertible notes outstanding of $976.3 thousand. The Company had entered into convertible note agreements with certain institutional and accredited investors on May 22, 2007 for amounts totaling $1.5 million. The convertible notes bore interest at the rate of 8% per annum, payable quarterly. The assets of the Company, which had been pledged as security of the convertible notes, were released upon repayment of the convertible notes.
Research and Development Projects:
On April 6, 2009 IntelGenx submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CPI-300. CPI-300 is a higher strength of the antidepressant bupropion HCl, the active ingredient in Wellbutrin XL(R). The NDA was accepted for standard review by the FDA in June 2009. As required under NDA filings, IntelGenx' development partner Cary Pharmaceuticals (Cary), the NDA applicant, notified Biovail Laboratories SLR (Biovail), holder of the Wellbutrin XL patent of the filing contending non-infringement of the Wellbutrin XL patent.
On August 18, 2009, Cary was sued by Biovail in the U.S. District Court of Delaware for patent infringement, under provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), with respect to Biovail's U.S. Patent No. 6,096,341. Pursuant to the Hatch-Waxman Act, the filing of the patent infringement lawsuit by Biovail instituted an automatic stay of FDA approval of the NDA until the earlier of a judgment or January 3, 2012. Any decision could have an effect on IntelGenx' potential revenues relating to CPI-300. IntelGenx believes CPI-300 does not infringe Biovail's patent and is vigorously defending its position.
Subsequent to the end of the fiscal year:
On January 11, 2010 IntelGenx announced a manufacturing site change for CPI-300. The original manufacturer, PharmPro of Aurora, IL, was sold to URL Pharma of Philadelphia, PA. As a result of this acquisition, URL advised IntelGenx they would no longer manufacture CPI-300. IntelGenx has identified and engaged Pillar5 Pharma, Arnprior, ON, as the new manufacturing facility for the product. Arnprior is a state-of-the-art GMP facility with a long-standing record of manufacturing quality product for the pharmaceutical industry. As a result of the manufacturing site change, IntelGenx and Cary are preparing an amendment to the NDA.
On January 21, 2010 IntelGenx announced the U.S. Patent and Trademark Office issued a formal Notice of Allowance for the patent application protecting CPI-300. The patent was issued on March 9, 2010 under the number US 7,674,479. The patent will be listed in the FDA's Orange Book and will provide broad protection for CPI-300 against generic copies.
On February 8, 2010 IntelGenx received a Complete Response Letter from the FDA regarding CPI-300. The Complete Response Letter lists two main issues which need to be addressed before obtaining final approval: 1) qualification of Pillar5 as the commercial manufacturing site and 2) an observed food effect seen with CPI-300 and the reference product. The FDA found no other notable deficiencies in the NDA. IntelGenx believes the food effect issue can be addressed through a label adjustment and post-approval education. In addition, the company plans to conduct a pilot food effect study with CPI-300 tablets having a modified enteric coating. In the coming weeks IntelGenx will request a meeting with FDA to clarify the steps necessary to obtain approval. IntelGenx is confident the activities required to support the NDA amendment can be completed in time for a submission in the second half of 2010.
Neuropathic Pain Tablet:
On April 14, 2009 IntelGenx and its development partner, Cannasat Therapeutics Inc. (Cannasat), announced positive Phase 1b results for Relivar, a buccal formulation of dronabinol. The randomized, single dose, double blind crossover study compared Cannasat's Relivar with Marinol 2.5 mg in healthy volunteers. Relivar delivered twice the amount of dronabinol into the bloodstream as the brand with no increase in side effects due to a corresponding reduction in the metabolite responsible for the CNS adverse effects of dronabinol. Relivar was developed using IntelGenx' proprietary AdVersa™ buccal delivery technology.
Subsequent to the end of the fiscal year, on March 4, 2010 IntelGenx and Cannasat announced the signing of a Letter of Intent for a definitive license agreement under which IntelGenx would acquire a fifty percent ownership stake from Cannasat and an exclusive worldwide license to develop and commercialize Relivar. Upon completion of the transaction, IntelGenx would assume sole product development and commercialization rights for Relivar and would forgive approximately CAD$231 thousand of debt owed by Cannasat.
On April 20, 2009 IntelGenx announced results of a pilot study showing development of a product bioequivalent to a leading antihypertensive. The product was developed using IntelGenx' proprietary VersaTab™ delivery technology. Scale-up activities are ongoing at the contract manufacturer. The product is being developed under a strategic alliance between IntelGenx and DAVA Pharmaceuticals Inc. (DAVA). Under terms of the alliance, IntelGenx will complete the development. DAVA has commercialization rights in the U.S. IntelGenx will receive development milestones and a share of DAVA's revenues.
On November 17, 2009 IntelGenx announced results of a pilot study showing successful development of a product bioequivalent to a leading anti-migraine therapy. The product was developed using IntelGenx' proprietary VersaFilm™ drug delivery technology. It is anticipated the pivotal bioequivalence study will be conducted in 2010 and the NDA filed shortly thereafter.
Subsequent to the end of the fiscal year, on January 25, 2010 IntelGenx announced a strategic alliance with LTS Lohmann Therapie-Systeme AG (LTS) for the exclusive manufacturing of pharmaceutical products developed by IntelGenx using its VersaFilm™ drug delivery technology. VersaFilm™ is comprised of a thin polymeric film using components that are safe and approved by the FDA. VersaFilm™ provides a patent-protected method of re-formulating approved pharmaceuticals in a more convenient and discrete oral dosage form. IntelGenx currently has three products in development using the VersaFilm™ technology.
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 gastro-intestinal 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 pain, hypertension, osteoarthritis, and depressive disorders. 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, 2008, 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.
IntelGenx Technologies Corp.
Dr. Horst G. Zerbe
President and CEO
+1 514-331-7440 (ext. 201)
+1 514-331-0436 (FAX)