SAINT LAURENT, Quebec, March 26, 2020 — IntelGenx Technologies Corp. (TSX V:IGX)(IGXT) (the “Company” or “IntelGenx”) today reported financial results for the fourth quarter and twelve-month periods ended December 31, 2019. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.
2019 Fourth Quarter Financial Highlights:
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Revenue was $68,000, compared to $651,000 in the 2018 fourth quarter
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Adjusted EBITDA was ($2.1 million), compared to ($2.0 million) in Q4-2018
2019 Full-Year Financial Highlights:
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Revenue was $742,000, compared to $1.8 million in 2018
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Net comprehensive loss was $10.3 million, compared to net comprehensive loss of $10.6 million in 2018
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Adjusted EBITDA was ($8.5 million), compared to ($7.9 million) in 2018
Recent Highlights:
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Closed an offering of 16,317,000 units (the “Units”) at a price of C$0.50 per Unit for gross proceeds of C$8.2 million.
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Received a No Objection Letter from Health Canada in response to IntelGenx’s amended Clinical Trial Application for the ongoing Montelukast VersaFilm® Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease.
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Announced that a cannabis-infused VersaFilm® product has been finalized with its co-development partner, Tilray, Inc. (TLRY) (“Tilray®”) and all manufacturing scale-up work has been successfully completed.
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Signed a binding term sheet with Orivas for the commercialization of RIZAPORT® pursuant to which Orivas will obtain exclusive rights to market and sell RIZAPORT® in Lithuania, Latvia, Estonia and Poland, with the right of first refusal for a predefined term to include the Republic of Belarus and/or the Republic of Ukraine, as well as any of the Scandinavian countries (Finland, Denmark, Sweden and Norway).
“There are several very near-term milestones that represent potential value inflection points for our Company,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “We are anticipating receipt of the U.S. Food and Drug Administration’s decision on our 505(b)(2) New Drug Application for RIZAPORT® VersaFilm® for the treatment of acute migraines later today. On the heels of that, we also expect to receive Health Canada’s requisite micro-processing license in the coming weeks, which will enable us to begin commercial production of cannabis-infused oral films for our partner, Tilray®, with product sales expected to begin as soon as practicable thereafter. In addition, we are planning to resume enrollment for our Phase 2a BUENA trial at our Canadian sites under a Health Canada-approved dose increase and are looking forward to providing initial trial data as they become available.”
Financial Results:
Total revenues for the three-month period ended December 31, 2019 amounted to $68,000, a decrease of $583,000 compared to $651,000 for the three-month period ended December 31, 2018. The change is mainly attributable to a decrease in R&D revenues of $583,000. Operating costs and expenses were $2.4 million for the fourth quarter 2019, versus $2.9 million for the corresponding three-month period of 2018. For Q4-2019, the Company had an operating loss of $2.4 million, compared to operating loss of $2.2 million for the comparable period of 2018.
Total revenues for the twelve-month period ended December 31, 2019 amounted to $742,000, compared to $1.8 million for the twelve-month period ended December 31, 2018. Operating costs and expenses were $10.3 million for the full year 2019, versus $10.8 million for the corresponding 12-month period of 2018. For the twelve-month period of 2019, the Company had an operating loss of $9.6 million, compared to an operating loss of $9.0 million for the comparable period of 2018. Net comprehensive loss was $10.3 million, or $0.11 per basic and diluted share, for the twelve-month period of 2019, compared to net comprehensive loss of $10.6 million, or $0.14 per basic and diluted share, for the comparable period of 2018.
As at December 31, 2019, the Company’s cash and short-term investments totalled $1.9 million, which did not include gross proceeds of C$8.2 million raised by the Company in its February 2020 equity offering.
Annual Filings:
The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2019, as well as its 2020 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, Thursday, March 26, 2020 at 9:00 a.m. ET.
Conference Call Details:
IntelGenx will host a conference call to discuss these 2019 fourth quarter and full year financial results on Friday, March 27, 2020 at 8:30 a.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 5685777. The call will be also be webcast live and archived for twelve months at www.intelgenx.com.
About IntelGenx
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s superior film technologies, including VersaFilm®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer significant benefits to patients and physicians for many therapeutic conditions.
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 offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit 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, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on IntelGenx`s operations, the demand for its products, global supply chains and economic activity in general. 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.
For IntelGenx:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
[email protected]
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
[email protected]