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 quarter ended June 30, 2023.
“Our continued progress advancing our
development and regulatory strategies are evolving and designed to
provide us with a pathway towards our first-in-human clinical
studies with our lead indication, neuromyelitis optica spectrum
disorder (NMOSD). Further, we established solid traction with our
ongoing DETECT trial and are working towards meeting our goal of
completing enrollment by year's end,” commented Dr. Klaus Paulini,
Chief Executive Officer of Aeterna. “Importantly, we have
maintained a strong cash position to enable us to continue our
strategy.”
Summary of Second
Quarter 2023
Financial Results
All amounts are in U.S. dollars
Cash and cash equivalents
The Company had $42.2 million in cash and cash equivalents at
June 30, 2023.
Results of operations for the three-month period
ended June 30, 2023
For the three-month period ended June 30, 2023,
we reported a consolidated net loss of $2.5 million, or $0.52 loss
per common share (basic and diluted), as compared with a
consolidated net loss of $4.2 million, or $0.87 net loss per common
share (basic) for the three-month period ended June 30, 2022.
Revenues
- Our total revenue for the
three-month period ended June 30, 2023 was $2.2 million as compared
with ($0.2 million) for the same period in 2022, representing an
increase of $2.4 million. The increase was due primarily to an
increase in license fee revenue recognized of $1.0 million and
development services revenue of $1.4 million relating to the
Company’s amended agreement with Novo Nordisk Healthcare.
Operating Expenses
- Our total operating expenses for
the three-month period ended June 30, 2023 were $5.1 million as
compared with $4.5 million for the same period in 2022,
representing an increase of $0.6 million. This increase arose from
a $0.5 million increase in research and development expenses,
primarily related to our DETECT trial, and a $0.1 million increase
in cost of sales.
Net Finance Income
- For the three-month period ended
June 30, 2023, our net finance income was $0.3 million as compared
to $0.5 million for the three-month period ended June 30, 2022,
representing a decrease of $0.2 million. This decrease was the
result of a $0.5 million decrease in gains due to changes in
foreign currency rates offset by a $0.3 million increase in
interest income.
Results of operations for the
six-month period ended
June 30, 2023
For the six-month period ended June 30, 2023, we
reported a consolidated net loss of $6.8 million, or $1.39 loss per
common share (basic and diluted), as compared with a consolidated
net loss of $6.9 million, or $1.41 net loss per common share
(basic) for the six-month period ended June 30, 2022.
Revenues
- Our total revenue for the six-month
period ended June 30, 2023, was $4.4 million as compared to $1.3
million for the same period in 2022, representing an increase of
$3.1 million. The increase was primarily due to an increase in
license fee revenue recognized of $1.3 million and development
services revenue of $1.9 million relating to the Company’s amended
agreement with Novo Nordisk Healthcare, offset by a $0.1 million
decrease in product sales.
Operating Expenses
- Our total operating expenses for
the six-month period ended June 30, 2023 were $11.4 million as
compared with $8.8 million for the same period in 2022,
representing an increase of $2.6 million. This increase arose from
a $2.1 million increase in research and development expenses,
primarily related to our DETECT trial and our AEZS-130 Macimorelin
ALS project, increases of $0.4 million in selling, general &
administrative expenses, and a $0.1 million increase in cost of
sales.
Net Finance Income
- For the six-month period ended June
30, 2023, our net finance income was $0.3 million as compared to
$0.7 million for the six-month period ended June 30, 2022,
representing a decrease of $0.4 million. This decrease was the
result of a $0.7 million decrease in gains due to changes in
foreign currency rates offset by a $0.3 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 second quarter 2023, as well as the Company's
unaudited consolidated interim financial statements as of June 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.
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.
Aeterna Zentaris is dedicated to the development
of its therapeutic asset and has established a pre-clinical
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).
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 ability to use cash to fund its future
operations; recruitment efforts with respect to the DETECT trial;
plans regarding first-in-human studies; and commercialization
efforts regarding macimorelin.
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: we
may not be successful in finding a commercialization partner for
Macrilen® (macimorelin) in North America or other territories not
currently partnered; we may not be able to re-launch sales of
Macrilen® (macimorelin) in the United States; our reliance on the
success of the DETECT trial in CGHD; results from our ongoing or
planned pre-clinical studies and our DETECT trial 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 macimorelin (Macrilen®; GHRYVELIN™) and related
out-licensing arrangements and the continued availability of funds
and resources to successfully commercialize the product; 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: +1 (833) 475-8247E: aezs@jtcir.com
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