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Aeterna Zentaris loses $4.1-million (U.S.) in Q3

2023-11-09 13:55 ET - News Release

Dr. Klaus Paulini reports

AETERNA ZENTARIS REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS

Aeterna Zentaris Inc. has released its financial and operating results for the quarter ended Sept. 30, 2023. "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 U.K., 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 Sept. 30, 2023.

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

For the three-month period ended Sept. 30, 2023, Aeterna reported a consolidated net loss of $4.1-million, or 85 cents per common share (basic and diluted), as compared with a consolidated net loss of $3.4-million, or 70 cents per common share (basic), for the three-month period ended Sept. 30, 2022.

Revenues:

  • Aeterna's total revenue for the three-month period ended Sept. 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 on boarding Aeterna's 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:

  • Aeterna's total operating expenses for the three-month period ended Sept. 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 $500,000 decrease in research and development expenses, related to a decrease of $400,000 in Aeterna's AEZS-130 Macimorelin ALS project and a net decrease of $100,000 for all other projects, as well as a $500,000 decrease in the selling, general and administrative expenses.

Net finance income:

  • For the three-month period ended Sept. 30, 2023, Aeterna's net finance income was $400,000 as compared with $300,000 for the three-month period ended Sept. 30, 2022, representing an increase of $100,000. This was primarily due to an increase in interest earned on bank deposits of $400,000, offset by a $300,000 decrease in the company's gain (loss) due to changes in foreign currency.

Results of operations for the nine-month period ended Sept. 30, 2023

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

Revenues:

  • Aeterna's total revenue for the nine-month period ended Sept. 30, 2023, was $4.4-million, as compared with $3.2-million for the same period in 2022, representing an increase of $1.2-million. The increase was due to an increase in licence fee revenue recognized of $700,000 and development services revenue of $700,000 relating to the company's amended agreement with Novo Nordisk Healthcare, offset by a combined $200,000 decrease in all other revenues.

Operating expenses:

  • Aeterna's total operating expenses for the nine-month period ended Sept. 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 $900,000 increase in the Detect trial, a $500,000 increase in the company's AEZS-130 Macimorelin ALS project and a $400,000 increase in the company's AIM-Biologicals -- NMOSD project, offset by a decrease of approximately $400,000 for all other projects.

Net finance income:

  • For the nine-month period ended Sept. 30, 2023, Aeterna's net finance income was $700,000 as compared with $1.0-million for the nine-month period ended Sept. 30, 2022, representing a decrease of $300,000. This decrease was the result of a $1.0-million decrease in gains due to changes in foreign currency rates, offset by a $700,000 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 Sept. 30, 2023, will be available on the company's website in the investors section or on the company's profile on SEDAR+ and EDGAR.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products focused on areas of significant unmet medical need. The company's lead product, macimorelin (Macrilen; Ghryvelin), is the first and only U.S. Food and Drug Administration- and European Commission-approved oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The company is leveraging the clinical success and compelling safety profile of macimorelin to develop it for the diagnosis of childhood-onset growth hormone deficiency (CGHD), an area of significant unmet need.

Aeterna Zentaris is dedicated to the development of its therapeutic asset and has established a preclinical development pipeline to potentially address unmet medical needs across a number of indications, including neuromyelitis optica spectrum disorder (NMOSD), Parkinson's disease (PD), hypoparathyroidism and amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease).

We seek Safe Harbor.

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