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, today reported its financial and operating
results for the year ended December 31, 2022.
“Over the course of 2022 we made important
pipeline progress and timely decisions through our pre-established
go/no-go milestones related to the advancement of our development
programs. Through this disciplined process, we have further
prioritized our pipeline which enables us to focus our resources
accordingly. Our active development programs continue to progress
and we remain focused on driving enrollment in our ongoing DETECT
trial and aim to continue exploring all strategic options for our
Macrilen™ asset,” commented Dr. Klaus Paulini, Chief Executive
Officer of Aeterna.
Summary of Fourth Quarter and Full Year
2022 Financial
Results
All amounts are in U.S. dollars
Cash and cash equivalents
The Company had $50.6 million in cash and cash equivalents at
December 31, 2022.
Results of operations for the three-month period ended
December 31, 2022
For the three-month period ended December 31,
2022, we reported a consolidated net loss of $12.5 million, or
$2.56 loss per common share (basic and diluted), as compared with a
consolidated net loss of $2.9 million, or $0.63 loss per common
share (basic and diluted) for the three-month period ended December
31, 2021. The $9.6 million increase in net loss is primarily from a
$2.5 million increase in total research and development expenses, a
$8.3 million charge for the impairment of goodwill (non-cash),
intangible assets and other assets, a $0.4 million decrease in net
finance income, offset by a $1.5 million increase in revenues and a
$0.1 million decrease in cost of sales and selling, office and
general administration expenses.
Revenues
-
Our total revenue for the three-month period ended December 31,
2022 was $2.5 million as compared to $1.0 million for the same
period in 2021, representing an increase of $1.5 million, primarily
due to $0.5 million increase in License fees and $1.0 million
increase in Development services relating to our DETECT trial.
Operating Expenses
-
Our total operating expenses for the three-month period ended
December 31, 2022 was $14.8 million as compared with $4.1 million
for the same period in 2021, representing an increase of $10.7
million. This increase arises primarily from a $2.5 million
increase in research and development expenses, a $8.3 million
charge for the impairment of goodwill (non-cash), intangible assets
and other assets, offset by a $0.1 million reduction in cost of
sales and selling, general and administrative expenses.
Net Finance Income
-
For the three-month period ended December 31, 2022, our net finance
cost was $0.1 million as compared to $0.2 million net finance
income for the three-month period ended December 31, 2021.
Results of operations for the year ended December 31,
2022
For the twelve-month period ended December 31,
2022, we reported a consolidated net loss of $22.7 million, or
$4.68 loss per common share (basic and diluted), as compared with a
consolidated net loss of $8.4 million, or $1.82 loss per common
share (basic and diluted), for the year ended December 31, 2021.
The $14.3 million increase in net loss is primarily from a $15.3
million increase in operating expenses offset by an increase of
$0.3 million in total revenues and a $0.7 million increase in net
finance income.
Revenues
-
Our total revenue for the twelve-month period ended December 31,
2022 was $5.6 million as compared to $5.3 million for the same
period in 2021, representing an increase of $0.3 million, primarily
due to $0.3 million increase in development services relating to
our DETECT trial.
Operating Expenses
-
Our total operating expenses for the twelve-month period ended
December 31, 2022 was $29.2 million as compared with $13.9 million
for the same period in 2021, representing an increase of $15.3
million. This increase arises primarily from a $5.9 million
increase in research and development expenses, a $8.3 million
charge for the impairment of goodwill (non-cash), intangible assets
and other assets, a $0.9 million increase in selling general and
administration expenses and a $0.1 million increase in cost of
sales.
Net Finance Income
-
Our net finance income for the twelve-month period ended December
31, 2022, was $0.9 million as compared with $0.2 million for the
same period in 2021, representing a increase of $0.7 million. This
is primarily due to a $0.7 increase in gains due to foreign
currency exchange rates.
Consolidated Financial Statements and Management's
Discussion and Analysis
For reference, the Management's Discussion and
Analysis of Financial Condition and Results of Operations for the
fourth quarter and full year 2022, as well as the Company's
consolidated financial statements as of December 31, 2022, will be
available on the Company's website (www.zentaris.com) in the
Investors section or at the Company's profile at www.sedar.com and
www.sec.gov.
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. FDA 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, in collaboration with Novo Nordisk.
Aeterna Zentaris is dedicated to the development
of therapeutic assets and has recently taken steps to establish a
growing pre-clinical 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).
For more information, please visit
www.zentaris.com and connect with the Company on Twitter, LinkedIn
and Facebook.
Forward-Looking Statements
This press release contains statements that may
constitute forward-looking statements within the meaning of U.S.
and Canadian securities legislation and regulations, and such
statements are made pursuant to the safe-harbor provision of the
U.S. Securities Litigation Reform Act of 1995. Forward-looking
statements are frequently, but not always, identified by words such
as "expects," "aiming", "anticipates," "believes," "intends,"
"potential," "possible," and similar expressions. Such statements,
based as they are on current expectations of management, inherently
involve numerous risks, uncertainty and assumptions, known and
unknown, many of which are beyond our control.
Forward-looking statements in this press release
include, but are not limited to, those relating to Aeterna's
expectations regarding: its preclinical and clinical studies, its
ability to secure regulatory approvals for Macrilen™, its efforts
to obtain a development and commercialization partner for Macrilen™
in the U.S. and Canada and the ability to meet its currently
anticipated cash needs into 2025.
Forward-looking statements involve known and
unknown risks and uncertainties, and other factors which may cause
the actual results, performance or achievements stated herein to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
information. Such risks and uncertainties include, among others,
our reliance on the success of the DETECT clinical trial in the
European Union and U.S. for Macrilen™ (macimorelin) in CGHD;
results from our ongoing or planned pre-clinical studies and our
DETECT clinical trial under development may not be successful or
may not support advancing the product further in pre-clinical
studies, to human clinical trials or regulatory approval; our
ability to raise capital and obtain financing to continue our
currently planned operations; our now heavy dependence on the
success of Macrilen™ (macimorelin) and related out-licensing
arrangements and the continued availability of funds and resources
to successfully commercialize the product; the global instability
due to the global pandemic of COVID-19 and the war in the Ukraine,
and their unknown potential effect on our planned operations; our
ability to enter into out-licensing, development, manufacturing,
marketing and distribution agreements with other pharmaceutical
companies and keep such agreements in effect; and our ability to
continue to list our common shares on the NASDAQ. Investors should
consult our quarterly and annual filings with the Canadian and U.S.
securities commissions for additional information on risks and
uncertainties, including those risks discussed in our Annual Report
on Form 20-F and annual information form, under the caption "Risk
Factors". Given the uncertainties and risk factors, readers are
cautioned not to place undue reliance on these forward-looking
statements. We disclaim any obligation to update any such factors
or to publicly announce any revisions to any of the forward-looking
statements contained herein to reflect future results, events or
developments, unless required to do so by a governmental authority
or applicable law.
No securities regulatory authority has either
approved or disapproved of the contents of this news release. The
Toronto Stock Exchange accepts no responsibility for the adequacy
or accuracy of this release.
Investor Contact:
Jenene ThomasJTC TeamT (US): +1 (833) 475-8247E:
aezs@jtcir.com
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