Dr. Klaus Paulini
AETERNA ZENTARIS REPORTS FOURTH QUARTER AND FULL-YEAR 2019 FINANCIAL AND OPERATING RESULTS AND PROVIDES BUSINESS UPDATE
Aeterna Zentaris Inc. has released its financial and operating results for the fourth quarter and year ended Dec. 31, 2019.
The Company also provided an update on its clinical program to develop
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."
- 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.
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.
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.
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
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.
Condensed Consolidated Statements of Comprehensive Loss Information
(in thousands, except share and per share data)
Three months ended December 31, Years ended December 31,
2019 2018 2019 2018 2017
$ $ $ $ $
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
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:
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)
We seek Safe Harbor.
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