IntelGenx is a double from here, says Leede Jones Gable

Leede Jones Gable analyst Douglas Loe is staying bullish on health tech company IntelGenx Technologies (IntelGenx Technologies Stock Quote, Chart, News, Analysts, Financials TSXV:IGX) after its recent fourth quarter report. In an update to clients on Friday, Loe maintained his “Speculative Buy” rating and C$1.00 target price, which at the time of publication represented a projected one-year return of 100 per cent.

Drug delivery tech company IntelGenx, which develops and manufactures pharmaceutical films, including VersaFilm, DisinteQ, VetaFilm and transdermal VevaDerm, released its Q4 full year 2020 financials on Thursday, posting fourth quarter revenue of $790,000 compared to $68,000 a year earlier with an adjusted EBITDA loss of $754,000 compared to a loss of $2.1 million for Q4 2019. (All figures in US dollars except where noted otherwise.)

IntelGenx said the boost in revenue was due to increases from licensing agreements and an increase in R&D revenues, while operating costs and expenses went to $1.8 million for the Q4 versus $2.4 million a year earlier. For the year, IntelGenx hit revenue of $1.5 million, double the $742,000 from 2019, and adjusted EBITDA was a loss of $5.3 million versus a loss of $8.5 million for 2019.

On the company’s progress since the end of 2020, big on the list of events was the strategic partnership, announced on March 15, with global biotech company ATAI Life Sciences, which includes a roughly $12-million equity investment by ATAI for about 25 per cent of IntelGenx, along with ATAI granting a $2-million secured loan to IGX.

“While we were pleased to see the positive impact of our performance improvement program continuing to be reflected in our financial results, it was the transformative partnership that we entered into with [ATAI Life Sciences] subsequent to year-end that truly served to validate our long-term growth strategy,” said IntelGenx CEO Dr. Horst G. Zerbe in the fourth quarter press release.

“We are confident that this transaction is the best way forward to maximize value for our shareholders, and encourage them to vote ‘FOR’ all related proposals at our Annual Meeting on May 11, 2021,” Zerbe said.

Also post-Q4, IntelGenx received its first purchase order for CBD filmstrips from Canadian medical cannabis company Heritage Cannabis using IGX’s VersaFilm technology. The first order is for 75,000 CBD Filmstrips with the shipment to take place in the second quarter this year.

Commenting on IGX’s fourth quarter and full 2020 report, Loe said the Q4 and full year results were in line with his expectations but that ultimately they were not yet impactful on his valuation, which at this point is more focused on the company hitting developmental milestones. The analyst said overall, IGX’s product lines based on its sublingual thin-film drug delivery platform VersaFilm are all advancing at a “pandemically-constrained” pace but they are nonetheless moving forward.

On IGX’s NDA to the US FDA for Rizaport, the company’s thin-film rizatriptan formulation, Loe said IntelGenx received a Complete Response Letter from the NDA in late Q1 2020 and that IGX is currently revising its filing, although the analyst said there should be no lingering issues with the underlying pharmacology of rizatriptan itselt and that any manufacturing and quality assurance measures to be dealt with should be logistically resolvable. Loe said he’s optimistic the NDA can be re-submitted in the next quarter or two, with the same product’s launch in Spain via a regional partner to come before the end of the Q2 2021.

Loe said IGX’s thin-film tadalafil appears to be undergoing its own rizaport-like regulatory journey, with an NDA resubmission still pending. Yet Loe said he’s encouraged that the drug, identified by partner firm Aquestive Therapeutics as AQST-119, has been categorized as ‘filed.’ Loe said that indicates to him, “that tadalafil remains a core pipeline asset in Aquestive’s portfolio and not just in IntelGenx’s portfolio.”

As well, Loe said IGX’s clinical prospects for a montelukast VesaFilm trial with patients with mild to moderate Alzheimer’s “remain strong in our view.”

On IGX going forward, Loe wrote, “We will clearly be watching for an update on the pace of development for VersaFilm-based psychedelic drugs through the ATAI and Cybin alliances and on regulatory status for Rizaport/AQST-119. We do not yet incorporate any VersaFilm/psychedelic product sales in our model, but we expect to revisit this assumption once design lock on a specific drug candidate/formulation is achieved and clinical testing commences.”

“The Phase II VersaFilm montelukast program may take a quarter or two for patient enrolment to be revitalized but we are still assuming that meaningful clinical data on six- month cognitive impact could be available in F2022,” he said.

By the numbers, Loe thinks IGX will generate 2021 revenue and EBITDA of $10.3 million and $2.3 million, respectively, and 2021 revenue and EBITDA of $18.3 million and $10.0 million, respectively.