Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (“Aeterna” or the
“Company”), a specialty biopharmaceutical company commercializing
and developing therapeutics and diagnostic tests, today reported
its financial and operating results for the fourth quarter and year
ended December 31, 2019.
The Company also provided an update on its
clinical program to develop macimorelin for the diagnosis of
child-onset growth hormone deficiency (CGHD), an area of
significant unmet need, and its plans to expand macimorelin for the
diagnosis of adult growth hormone deficiency (AGHD) in
Europe.
“We have been working diligently with our U.S.
and Canadian commercialization partner, Novo Nordisk, to increase
the awareness and access to Macrilen™ (macimorelin) for the
diagnosis of AGHD and are pleased with the progress made in this
regard over the fourth quarter of 2019. The inclusion of
macimorelin in the American Association of Clinical
Endocrinologists 2019 Guidelines was an important milestone that
reflects the hard work of both teams and we intend to build on this
momentum,” commented Dr. Klaus Paulini, Chief Executive Officer of
Aeterna Zentaris. “Additionally, our business development efforts
to secure a marketing partner for macimorelin for the diagnosis of
AGHD in Europe and other key markets remain ongoing.”
Recent Highlights
- Closed $4.5 million registered direct offering priced
at-the-market;
- Announced the completion of patient recruitment in the
AEZS-130-P01 (“Study P01”) dose-finding pediatric study of
macimorelin; and
- Announced the inclusion of macimorelin in the American
Association of Clinical Endocrinologists (AACE) and American
College of Endocrinology (ACE) 2019 Guidelines for Management of
Growth Hormone Deficiency in Adults and Patients Transitioning from
Pediatric to Adult Care.
Dr. Paulini continued, “We also see a
significant opportunity in the use of macimorelin for the diagnosis
of CGHD and with the upcoming results of the P01 study expected
early next quarter, we believe we will be well positioned with a
validated dose to move into our planned P02 study, an efficacy and
safety registration study.”
For more information about Study P01, please
visit EU Clinical Trials Register and reference EudraCT
#2018-001988-23.
Macimorelin
The Company’s lead product, macimorelin, is the
only FDA approved oral drug indicated for the diagnosis of AGHD and
is currently marketed in the United States under the tradename
Macrilen™, by Novo Nordisk. Aeterna is currently developing
macimorelin for the diagnosis of CGHD, an area of significant unmet
need, in collaboration with Novo Nordisk.
Upcoming Anticipated Program
Milestones
- Announce results of CGHD dose-ranging study (AEZS-130-P01) in
Q2 2020;
- Commence CGHD safety and efficacy study (AEZS-130-P02:
multi-national, including U.S.); and
- Advance business development efforts to secure a marketing
partner for macimorelin for the diagnosis of AGHD in Europe and
other key markets.
The Company is closely monitoring the evolving
situation with coronavirus, or COVID-19, and is following guidance
from health authorities. COVID-10 is affecting the global community
and is adversely affecting our business operations, in a manner
which at this time cannot be fully determined or quantified. The
situation with coronavirus is rapidly evolving and the impact of
COVID-19, including travel and business restrictions, and other
impediments to undertaking clinical studies, may significantly
affect our business, operations, results, projected timelines and
market price for our common shares. Like many of our peers, we have
put into place a robust risk mitigation plan to ensure the safety
of our employees, partners and community. For more information,
please see the Risk Factor entitled “The economic effects of a
pandemic, epidemic or outbreak of an infectious disease could
adversely affect our operations or the market price of our Common
Shares” in our Annual Report on Form 20-F for the year ended
December 31, 2019.
Summary of Full Year 2019 Financial
Results
All amounts are in U.S. dollars
For the twelve-month period ended December 31,
2019, the Company reported a consolidated net loss of $6.0 million,
or $0.35 loss per common share (basic), as compared with a
consolidated net income of $4.2 million, or $0.25 income per common
share (basic), for the twelve-month period ended December 31, 2018.
The $10.2 million decline in net results is primarily from a
reduction of $26.3 million in revenue offset by $5.6 million in tax
expense, $6.3 million decline in operating expenses, $2.8 million
increase in net finance income and $1.4 million decline in
settlements.
Revenues
- The Company reported total revenue for the twelve-month period
ended December 31, 2019 of $0.5 million as compared with $26.9
million for the same period in 2018, representing a decline of
$26.4 million. The decline in total revenue in 2019 relates
primarily to the one-time $24.0 million cash payment received from
executing the License Agreement in January 2018 and the initial
delivery of Macrilen™ (macimorelin) to our licensee.
Operating Expenses
- The Company reported total operating expense for the
twelve-month period ended December 31, 2019 of $10.8 million as
compared with $17.0 million for the same period in 2018,
representing a decrease of $6.2 million. This net decline arises
primarily from a $2.3 million reduction in general and
administration expenses, a $1.9 million reduction in selling costs,
a $1.7 million decline in cost of sales and a $1.1 million
reduction in research and development costs, offset by $0.5 million
increase in restructuring costs, $0.02 million impairment in right
to use asset[s] and $0.2 million write-off of
other current assets.
Net Finance Income
- The Company reported net finance income for the twelve-month
period ended December 31, 2019 of $4.0 million as compared with
$1.2 million for the same period in 2018, representing an increase
of $2.8 million. This is primarily due to a $4.3 million increase
change in fair value of warrant liability, offset by a reduction in
gain due to foreign currency exchange rates of $0.6 million and a
$0.9 million increase in other finance costs.
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 fiscal 2019, as well as the Company’s audited
consolidated financial statements as at December 31, 2019, 2018 and
for the years ended December 31, 2019, 2018 and 2017 will be
available at 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 Inc. is a specialty
biopharmaceutical company commercializing and developing
therapeutics and diagnostic tests. The Company’s lead product,
Macrilen™ (macimorelin), is the first and only U.S. FDA and
European Commission approved oral test indicated for the diagnosis
of adult growth hormone deficiency (AGHD). Macrilen™ is currently
marketed in the United States through a license agreement with Novo
Nordisk. Aeterna Zentaris retains its rights to macimorelin outside
of the U.S. and Canada.
Aeterna Zentaris is also leveraging the clinical
success and compelling safety profile of macimorelin to develop it
for the diagnosis of child-onset growth hormone deficiency (CGHD),
an area of significant unmet need.
The Company is actively pursuing business
development opportunities for the commercialization of macimorelin
in Europe and the rest of the world, in addition to other
non-strategic assets to monetize their value. For more information,
please visit the Company’s website at www.zentaris.com.
Condensed Consolidated Statements of Comprehensive Loss
Information
|
|
Three months
ended December 31, |
|
Years ended
December 31, |
(in thousands, except share
and per share data) |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
2017 |
|
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
Revenues |
|
|
|
|
|
|
|
|
|
|
License fees |
|
19 |
|
|
(332 |
) |
|
74 |
|
|
24,325 |
|
|
458 |
|
Product sales |
|
— |
|
|
1,446 |
|
|
129 |
|
|
2,167 |
|
|
— |
|
Royalty income |
|
16 |
|
|
184 |
|
|
45 |
|
|
184 |
|
|
— |
|
Sales commission |
|
— |
|
|
— |
|
|
— |
|
|
110 |
|
|
465 |
|
Supply chain |
|
(17 |
) |
|
94 |
|
|
284 |
|
|
95 |
|
|
— |
|
Total
revenues |
|
18 |
|
|
1,392 |
|
|
532 |
|
|
26,881 |
|
|
923 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
309 |
|
|
1,413 |
|
|
410 |
|
|
2,104 |
|
|
— |
|
Research and development
costs |
|
263 |
|
|
767 |
|
|
1,837 |
|
|
2,932 |
|
|
10,704 |
|
General and administrative
expenses |
|
1,691 |
|
|
1,665 |
|
|
6,615 |
|
|
8,894 |
|
|
8,198 |
|
Selling expenses |
|
38 |
|
|
588 |
|
|
1,214 |
|
|
3,109 |
|
|
5,095 |
|
Restructuring costs |
|
(266 |
) |
|
— |
|
|
507 |
|
|
— |
|
|
— |
|
Impairment of right of use
asset |
|
(254 |
) |
|
— |
|
|
22 |
|
|
— |
|
|
— |
|
Write-off of other current
assets |
|
— |
|
|
— |
|
|
169 |
|
|
— |
|
|
— |
|
Total operating expenses |
|
1,781 |
|
|
4,433 |
|
|
10,774 |
|
|
17,039 |
|
|
23,997 |
|
(Loss) income from
operations |
|
(1,763 |
) |
|
(3,041 |
) |
|
(10,242 |
) |
|
9,842 |
|
|
(23,074 |
) |
Settlements |
|
— |
|
|
(1,400 |
) |
|
— |
|
|
(1,400 |
) |
|
— |
|
Gain due to changes in foreign
currency exchange rates |
|
26 |
|
|
64 |
|
|
87 |
|
|
656 |
|
|
502 |
|
Change in fair value of
warrant liability |
|
533 |
|
|
(1,489 |
) |
|
4,518 |
|
|
263 |
|
|
2,222 |
|
Other finance (costs) income |
|
10 |
|
|
104 |
|
|
(593 |
) |
|
278 |
|
|
75 |
|
Net finance income
(costs) |
|
569 |
|
|
(1,321 |
) |
|
4,012 |
|
|
1,197 |
|
|
2,799 |
|
(Loss) income before
income taxes |
|
(1,194 |
) |
|
(5,762 |
) |
|
(6,230 |
) |
|
9,639 |
|
|
(20,275 |
) |
Income tax recovery
(expense) |
|
188 |
|
|
636 |
|
|
188 |
|
|
(5,452 |
) |
|
3,479 |
|
Net (loss)
income |
|
(1,006 |
) |
|
(5,126 |
) |
|
(6,042 |
) |
|
4,187 |
|
|
(16,796 |
) |
Other comprehensive
(loss) income: |
|
|
|
|
|
|
|
|
|
|
Foreign currency translation
adjustments |
|
(268 |
) |
|
(13 |
) |
|
83 |
|
|
(260 |
) |
|
(1,430 |
) |
Actuarial gain (loss) on
defined benefit plans |
|
959 |
|
|
(418 |
) |
|
(1,068 |
) |
|
193 |
|
|
694 |
|
Comprehensive (loss)
income |
|
(315 |
) |
|
(5,557 |
) |
|
(7,027 |
) |
|
4,120 |
|
|
(17,532 |
) |
Net loss per share
(basic) |
|
(0.05 |
) |
|
(0.31 |
) |
|
(0.35 |
) |
|
0.25 |
|
|
(1.12 |
) |
Net loss per share
(diluted) |
|
(0.05 |
) |
|
(0.31 |
) |
|
(0.35 |
) |
|
0.24 |
|
|
(1.12 |
) |
Condensed Statement of Financial Position
Information
|
|
December 31, |
(in thousands) |
|
2019 |
|
2018 |
|
|
$ |
|
$ |
Cash and cash equivalents |
|
7,838 |
|
|
|
14,512 |
|
Trade and other receivables
and other current assets |
|
1,869 |
|
|
|
1,504 |
|
Inventory |
|
1,203 |
|
|
|
240 |
|
Restricted cash
equivalents |
|
364 |
|
|
|
418 |
|
Property, plant and
equipment |
|
35 |
|
|
|
65 |
|
Right of use assets |
|
582 |
|
|
|
— |
|
Other non-current assets |
|
8,090 |
|
|
|
8,272 |
|
Total
assets |
|
19,981 |
|
|
|
25,011 |
|
Payables and accrued
liabilities and income taxes payable |
|
3,596 |
|
|
|
4,635 |
|
Current portion of provision
for restructuring and other costs |
|
418 |
|
|
|
887 |
|
Current portion of deferred
revenues |
|
991 |
|
|
|
74 |
|
Lease liabilities |
|
903 |
|
|
|
— |
|
Warrant liability |
|
2,255 |
|
|
|
3,634 |
|
Non-financial non-current
liabilities (1) |
|
14,281 |
|
|
|
13,874 |
|
Total
liabilities |
|
22,444 |
|
|
|
23,104 |
|
Shareholders'
(deficiency) equity |
|
(2,463 |
) |
|
|
1,907 |
|
Total liabilities and
shareholders' (deficiency) equity |
|
19,981 |
|
|
|
25,011 |
|
_________________________
(1)Comprised mainly of employee future benefits,
provisions for restructuring and other costs and non-current
portion of deferred revenues.
Forward-Looking Statements
This press release contains forward-looking
statements (as defined by applicable securities legislation) made
pursuant to the safe-harbor provision of the U.S. Securities
Litigation Reform Act of 1995, which reflect our current
expectations regarding future events. Forward-looking statements
include those relating to the intended use of proceeds and may
include, but are not limited to statements preceded by, followed
by, or that include the words "will," "expects," "believes,"
"intends," "would," "could," "may," "anticipates," and similar
terms that relate to future events, performance, or our results.
Forward-looking statements involve known and unknown risks and
uncertainties, including those discussed in this press release and
in our Annual Report on Form 20-F, under the caption "Key
Information - Risk Factors" filed with the relevant Canadian
securities regulatory authorities in lieu of an annual information
form and with the U.S. Securities and Exchange Commission. Known
and unknown risks and uncertainties could cause our actual results
to differ materially from those in forward-looking statements. Such
risks and uncertainties include, among others, our ability to raise
capital and obtain financing to continue our currently planned
operations, our ability to continue to list our Common Shares on
the NASDAQ, our ability to continue as a going concern is
dependent, in part, on our ability to transfer cash from Aeterna
Zentaris GmbH to Aeterna Zentaris and the U.S. subsidiary and
secure additional financing, 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, including our heavy
reliance on the success of the License Agreement with Novo, the
global instability due to the global pandemic of COVID-19, and its
unknown potential effect on our planned operations, including
studies, our ability to enter into out-licensing, development,
manufacturing, marketing and distribution agreements with other
pharmaceutical companies and keep such agreements in effect, our
reliance on third parties for the manufacturing and
commercialization of Macrilen™ (macimorelin), potential disputes
with third parties, leading to delays in or termination of the
manufacturing, development, out-licensing or commercialization of
our product candidates, or resulting in significant litigation or
arbitration, uncertainties related to the regulatory process,
unforeseen global instability, including the instability due to the
global pandemic of the novel coronavirus, our ability to
efficiently commercialize or out-license Macrilen™ (macimorelin),
our reliance on the success of the pediatric clinical trial in the
European Union (“E.U.”) and U.S. for Macrilen™ (macimorelin), the
degree of market acceptance of Macrilen™ (macimorelin), our ability
to obtain necessary approvals from the relevant regulatory
authorities to enable us to use the desired brand names for our
product, our ability to successfully negotiate pricing and
reimbursement in key markets in the E.U. for Macrilen™
(macimorelin), any evaluation of potential strategic alternatives
to maximize potential future growth and shareholder value may not
result in any such alternative being pursued, and even if pursued,
may not result in the anticipated benefits, our ability to take
advantage of business opportunities in the pharmaceutical industry,
our ability to protect our intellectual property, and the potential
of liability arising from shareholder lawsuits and general changes
in economic conditions. Investors should consult our quarterly and
annual filings with the Canadian and U.S. securities commissions
for additional information on risks and uncertainties. Given these
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.
Investor Contact:
Jenene Thomas JTC Team T (US): +1 (833) 475-8247 E:
aezs@jtcir.com
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