IntelGenx Reports Fourth Quarter and Full-Year 2022 Financial Results
IntelGenx Technologies Corp. (TSX:IGX)(OTCQB:IGXT) reported its financial results for Q4 and the full year 2022. For the fourth quarter, revenue declined to $173,000, down 65% from $494,000 in Q4 2021. Net comprehensive loss improved to $2.3 million from $2.9 million in the same quarter last year. For the full year, revenue decreased 38% to $1.0 million, with a net comprehensive loss of $11.6 million compared to $9.8 million in 2021. Key developments include a $3.0 million term loan received and an upcoming FDA decision on RIZAFILM®. The Company's cash position was $2.5 million as of December 31, 2022.
- Received a $3.0 million term loan from atai Life Sciences.
- FDA goal date set for April 17, 2023, for RIZAFILM® NDA review.
- Entered into research collaborations to investigate therapeutic options.
- Q4 revenue decreased by 65% year-over-year, primarily due to one-time licensing revenue in 2021.
- Full-year revenue dropped 38%, reflecting the absence of significant licensing deals.
- Net comprehensive loss increased from $9.8 million in 2021 to $11.6 million in 2022.
SAINT LAURENT, Quebec, March 29, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the three- and twelve-month periods ended December 31, 2022. 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.
"The progress we made throughout 2022 has led us to now being potentially on the cusp of a stage of anticipated rapid growth,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “In April, we expect the FDA’s decisions on the Buprenorphine Buccal Film ANDA, as well as the RIZAFILM® NDA. On the development front, we are also looking forward to atai announcing topline results from its Phase 1 clinical trial of Buccal VLS-01, the first ever in-human clinical study evaluating an all thin film psychedelic drug candidate.”
2022 Fourth Quarter Financial Highlights:
- Revenue was
$173,000 , compared to$494,000 in the 2021 fourth quarter, mostly due to one-time licensing revenue received in 2021. - Net comprehensive loss was
$2.3 million , compared to$2.9 million in the 2021 fourth quarter. - Adjusted EBITDA loss was
$2.3 million , essentially unchanged from Q4-2021.
2022 Full-Year Financial Highlights:
- Revenue was
$1.0 million , compared to$1.5 million in 2021, mostly due to one-time licensing revenue received in 2021. - Net comprehensive loss was
$11.6 million , compared to$9.8 million in 2021. - Adjusted EBITDA loss was
$8.5 million , compared to$7.1 million in 2021.
Fourth Quarter and Recent Developments:
- Received a fourth and final term loan tranche in the amount of
$3.0 million pursuant to the amended and restated secured loan agreement with the Company’s strategic partner, atai Life Sciences (“atai’). - Closed a private placement offering of convertible notes due March 1, 2027 for aggregate gross proceeds of approximately
$760,000 (C$1 million ).
- Received from the U.S. Food and Drug Administration (‘FDA”) a Prescription Drug User Fee Act (PDUFA) goal date of April 17, 2023 for completion of the Agency’s review of the 505(b)(2) New Drug Application (“NDA”) for RIZAFILM® VersaFilm®.
- Participated in the 35th Annual ROTH Conference in Dana Point, California.
- Granted a Notice of Allowance for U.S. Patent Application 16/053,383, entitled "Loxapine Film Oral Dosage Form,” from the United States Patent and Trademark Office.
- Entered into a research collaboration with Per Svenningsson, MD, PhD, of the Karolinska Institute, to plan and conduct a multicentre, randomized, double-blind, placebo-controlled clinical study to investigate the use of Montelukast VersaFilm® for the treatment of Parkinson’s Disease.
- Entered into an exclusive supply agreement for RIZAPORT® with ARWAN Pharmaceuticals Industries Lebanon s.a.l. in various countries in the Middle East and North Africa region.
- Entered into a research collaboration with the University of Prince Edward Island to assess palatability, owner-perceived acceptability, and ease of administration of the Company’s VetaFilm™ platform in healthy dogs and cats.
Financial Results:
Total revenues for the three-month period ended December 31, 2022 amounted to
Total revenues for the twelve-month period ended December 31, 2022 amounted to
As at December 31, 2022, the Company's cash and short-term investments totalled
Annual Filings:
The Company's annual report on Form 10-K and financial statements for the year ended December 31, 2022, as well as the 2023 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, March 29, 2023.
Conference Call Details:
IntelGenx will host a conference call to discuss these 2022 fourth quarter and full year financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (888) 506-0062 (Canada and the United States) or (973) 528-0011 (International); access code 884881. The call will be also be webcast live and archived on the Company's website at www.intelgenx.com under "Webcasts" in the Investors section.
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®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers 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 Information and 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 at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
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