On November 7, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, reported financial results for the third quarter ended September 30, 2019 (Press release, IntelGenx, NOV 7, 2019, View Source [SID1234550612]). 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.
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2019 Third Quarter Financial Summary:
Revenue was $61,000, compared to $700,000 in the third quarter of 2018
Adjusted EBITDA was ($2.3 million), unchanged from Q3-2018
Cash and short-term investments totaled $4.3 million as at September 30, 2019 compared to $2.2 million as at September 30, 2018
Recent Developments:
Received approval for prototype cannabis-infused VersaFilm product from co-development partner, Tilray (NASDAQ:TLRY), and initiated manufacturing scale-up work
Announced that its 505(b)(2) New Drug Application ("NDA") for RIZAPORT VersaFilm for the treatment of acute migraines was accepted for review by the U.S. Food and Drug Administration ("FDA") and that the FDA assigned a March 26, 2020, Prescription Drug User Fee Act ("PDUFA") goal date for completion of the review
Received a positive Data Safety Monitoring Board recommendation that the Company’s Montelukast VersaFilm Phase 2a (BUENA) clinical trial in patients with mild to moderate Alzheimer’s Disease continue
Presented an overview of the Company’s business at the H.C. Wainwright 21st Annual Global Investment Conference
"In many respects, we are now just nearing the starting line with the anticipated commercialization of our two lead VersaFilm products," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "The initiation of scale-up work for the cannabis-infused VersaFilm product we are co-developing with our worldwide partner, Tilray, and receipt of a PDUFA goal date for completion of the FDA’s review of the RIZAPORT NDA, mark important milestones. We are looking forward to unveiling details about our cannabis-infused oral film as we approach product launch, and as always, to updating our stakeholders as we continue to make progress toward bringing our VersaFilm products to market."
Financial Results:
Total revenues for the three-month period ended September 30, 2019 amounted to $61,000, compared to $700,000 for the three-month period ended September 30, 2018. The decrease is mainly attributable to a $639,000 decrease in Research and Development ("R&D") revenues.
Operating costs and expenses were $2.6 million for the third quarter of 2019, versus $3.3 million for the corresponding three-month period of 2018. The decrease for the three-month period ended September 30, 2019 is mainly attributable to a $610,000 decrease in R&D expenses and a $153,000 decrease in Selling, General and Administrative expenses.
For the third quarter of 2019, the Company had an operating loss of $2.5 million, compared to an operating loss of $2.6 million for the comparable period of 2018.
Net comprehensive loss for the three-month period ended September 30, 2019 was $2.9 million, or $0.03 on a basic and diluted per share basis, compared to $3.0 million, or $0.04 on a basic and diluted per share basis, for the comparable period of 2018.
As of September 30, 2019, the Company’s cash and short-term investments totalled $4.3 million.
Conference Call Details:
IntelGenx will host a conference call to discuss these 2019 third quarter financial results today at 4:30 p.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 5068946. A live and archived webcast of the call will be available on IntelGenx’s website at www.intelgenx.com under "Presentations" in the Investors section.