On November 9, 2023 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported its financial and operating results for the quarter ended September 30, 2023 (Press release, AEterna Zentaris, NOV 9, 2023, View Source;b=2533&ID=128359&m=rl&g=1592 [SID1234637443]).

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"We are pleased with the progress made in the last quarter with respect to the commercialization of Ghryvelin (macimorelin and previously sold in the United States as Macrilen) in the European Economic Area (EEA). Following regional pricing approvals, Pharmanovia, our commercialization partner in the EEA, has launched Ghryvelin in the UK, Germany, Scandinavia and other countries in the EEA, and is expecting to launch Ghryvelin in additional countries in the EEA during the remainder of 2023 and into the first half of 2024. In South Korea, Macrilen granules received MFDS approval in September so that, together with our partner NK Meditech, we are now preparing to launch Macrilen in the South Korean market," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna. "We are also encouraged with the progress we are making with our ongoing research program involving the use of the AIM biologics platform to treat neuromyelitis optica spectrum disorder (NMOSD) where we achieved ex-vivo proof of mode of action by regulatory T-Cell activation in human peripheral blood mononuclear cells of healthy donors and NMOSD patients. Our efforts to advance our programs are supported by our strong cash position which we believe enables us to meet our currently projected cash needs into 2025."

Summary of Third Quarter 2023 Financial Results

All amounts are in U.S. Dollars

Cash and cash equivalents

The Company had $38.8 million in cash and cash equivalents at September 30, 2023.

Results of operations for the three-month period ended September 30, 2023

For the three-month period ended September 30, 2023, we reported a consolidated net loss of $4.1 million, or $0.85 loss per common share (basic and diluted), as compared with a consolidated net loss of $3.4 million, or $0.70 loss per common share (basic) for the three-month period ended September 30, 2022.

Revenues

Our total revenue for the three-month period ended September 30, 2023, was $0.0 million as compared with $1.9 million for the same period in 2022, representing a decrease of $1.9 million. The decrease was due to required transition time in onboarding our new partner, Pharmanovia, as it pertained to marketing Ghryvelin in the European Economic Area and United Kingdom, as well as the termination of the Company’s amended agreement with Novo Nordisk Healthcare in May 2023.
Operating Expenses

Our total operating expenses for the three-month period ended September 30, 2023 were $4.6 million as compared with $5.6 million for the same period in 2022, representing a decrease of $1.0 million. This decrease arose from a $0.5 million decrease in research and development expenses, related to a decrease of $0.4 million in our AEZS-130 Macimorelin ALS project and a net decrease of $0.1 million for all other projects, as well as a $0.5 million decrease in the selling, general & administrative expenses.
Net Finance Income

For the three-month period ended September 30, 2023, our net finance income was $0.4 million as compared to $0.3 million for the three-month period ended September 30, 2022, representing an increase of $0.1 million. This was primarily due to an increase in interest earned on bank deposits of $0.4 million offset by a $0.3 million decrease in our gain (loss) due to changes in foreign currency.
Results of operations for the nine-month period ended September 30, 2023

For the nine-month period ended September 30, 2023, we reported a consolidated net loss of $10.9 million, or $2.25 loss per common share (basic and diluted), as compared with a consolidated net loss of $10.3 million, or $2.12 loss per common share (basic) for the nine-month period ended September 30, 2022.

Revenues

Our total revenue for the nine-month period ended September 30, 2023, was $4.4 million as compared to $3.2 million for the same period in 2022, representing an increase of $1.2 million. The increase was due to an increase in license fee revenue recognized of $0.7 million and development services revenue of $0.7 million relating to the Company’s amended agreement with Novo Nordisk Healthcare, offset by a combined $0.2 million decrease in all other revenues.
Operating Expenses

Our total operating expenses for the nine-month period ended September 30, 2023 were $16.0 million as compared with $14.4 million for the same period in 2022, representing an increase of $1.6 million. This increase was due to a $1.6 million increase in research and development expenses, primarily related to a $0.9 million increase in the DETECT trial, a $0.5 million increase in our AEZS-130 Macimorelin ALS project and a $0.4 million increase in our AIM-Biologicals – NMOSD project offset by a decrease of approximately $0.4 million for all other projects.
Net Finance Income

For the nine-month period ended September 30, 2023, our net finance income was $0.7 million as compared to $1.0 million for the nine-month period ended September 30, 2022, representing a decrease of $0.3 million. This decrease was the result of a $1.0 million decrease in gains due to changes in foreign currency rates offset by a $0.7 million increase in interest income.
Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Company’s Management’s Discussion and Analysis of Financial Condition and Results of Operations for the third quarter 2023, as well as the Company’s unaudited consolidated interim financial statements as of September 30, 2023, will be available on the Company’s website (www.zentaris.com) in the Investors section or at the Company’s profile at www.sedarplus.com and www.sec.gov.