SAINT LAURENT, Quebec, March 22, 2019 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx") today reported financial results for the fourth quarter and twelve-month periods ended December 31, 2018. All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.
2018 Fourth Quarter Financial Summary:
- Revenue was $650,000, compared to $1.5 million in the 2017 fourth quarter
- Adjusted EBITDA was ($2.0 million), compared to ($600,000) in Q4-2017
- Cash and short-term investments totaled $11.0 million as at December 31, 2018
2018 Full-Year Financial Summary:
- Revenue was $1.8 million, compared to $5.2 million in 2017
- Net comprehensive loss was $10.7 million, compared to net comprehensive loss of $2.7 million in 2017
- Adjusted EBITDA was ($7.9 million), compared to ($1.4 million) in 2017
Recent Operational Highlights:
- Announced U.S. Food and Drug Administration (“FDA”) acceptance of the RIZAPORT® New Drug Application (“NDA”) resubmission and the Agency’s assignment of a Prescription Drug User Fee Act (“PDUFA”) goal date of April 1, 2019
- Partnered with Gensco® Pharma to market RIZAPORT® in the United States
- Announced FDA pre-approval inspection of IntelGenx’s facility related to the RIZAPORT® NDA
- Granted Japanese patent for RIZAPORT® VersaFilm™
- Began Montelukast VersaFilm™ dosing in patients with mild to moderate Alzheimer’s Disease in Phase 2a study
- Announced Montreal’s Douglas Mental Health University Institute as ninth Montelukast VersaFilm™ Phase 2a clinical trial site
"The agreements we secured with Tilray® and Gensco Pharma® in 2018 represented an important inflection point for IntelGenx as we advanced our strategy to commercialize our pipeline of innovative oral film products with strong partners,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We have a very positive outlook for 2019 and 2020 and look forward to updating our stakeholders as we make progress towards achieving a number of key development and commercialization milestones.”
Financial Results:
Total revenues for the three-month period ended December 31, 2018 amounted to $650,000, a decrease of $850,000 compared to $1.5 million for the three-month period ended December 31, 2017. The change is mainly attributable to a decrease in deferred revenues partially offset by an increase in R&D revenues. Operating costs and expenses were $2.9 million for the fourth quarter 2018, versus $2.3 million for the corresponding three-month period of 2017. For Q4-2018, the Company had an operating loss of $2.2 million, compared to operating income of $850,000 for the comparable period of 2017.
Total revenues for the twelve-month period ended December 31, 2018 amounted to $1.8 million, compared to $5.2 million for the twelve-month period ended December 31, 2017. Operating costs and expenses were $10.8 million for the full year 2018, versus $7.7 million for the corresponding 12-month period of 2017. For the twelve-month period of 2018, the Company had an operating loss of $9.0 million, compared to an operating loss of $2.5 million for the comparable period of 2017. Net comprehensive loss was $10.7 million, or $0.14 per basic and diluted share, for the twelve-month period of 2018, compared to net comprehensive loss of $2.7 million, or $0.04 per basic and diluted share, for the comparable period of 2017.
As at December 31, 2018, the Company's cash and short-term investments totalled $11.0 million, compared with $4.9 million as at December 31, 2017.
Annual Filings:
The Company's annual report on Form 10-K and financial statements for the year ended December 31, 2018 as well as the 2019 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, Friday, March 22, 2019.
Conference Call Details:
IntelGenx will host a conference call to discuss these 2018 fourth quarter and full year financial results on Monday, March 25, 2019, at 8:00 a.m. EDT. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 1297963. The call will be also be webcast live and archived at www.intelgenx.com.
About IntelGenx:
Established in 2003, IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ technology platform.
IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility, established for the VersaFilm™ technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to its clients. More information about the company can be found at www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx's 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's 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's 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's annual report on Form 10-K, 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. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.