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Condensed Interim Consolidated Financial Statements (Unaudited) Aeterna Zentaris Inc. As at

Key Takeaway: Condensed Interim Consolidated Financial Statements Aeterna Zentaris Inc. As at March 31, 2019 and for the three-month periods ended March 31, 2019 and 2018 (presented in thousands of US dollars) Aeterna Zentaris Inc. Condensed Interim Consolidated Financial Statements (Unaud

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Condensed Interim Consolidated Financial Statements
Aeterna Zentaris Inc.
As at March 31, 2019 and for the three-month periods ended March 31, 2019 and 2018
(presented in thousands of US dollars)
Aeterna Zentaris Inc.
Condensed Interim Consolidated Financial Statements
(Unaudited)
As at March 31, 2019 and for the three-month periods ended March 31, 2019 and 2018
Condensed Interim Consolidated Statements of Financial Position 3
Condensed Interim Consolidated Statements of Changes in Shareholders' Equity (Deficiency) 4
Condensed Interim Consolidated Statements of Comprehensive Income (Loss) 5
Condensed Interim Consolidated Statements of Cash Flows 6
Notes to Condensed Interim Consolidated Financial Statements 7
Aeterna Zentaris Inc.
Condensed Interim Consolidated Statements of Financial Position
(in thousands of US dollars)
(Unaudited) March 31, 2019 December 31, 2018
$ $
ASSETS
Current assets
Cash and cash equivalents 11,357 14,512
Trade and other receivables (note 6) 612 294
Inventory 540 240
Prepaid expenses and other current assets 894 1,210
Total current assets 13,403 16,256
Restricted cash equivalents 363 418
Right of use assets (note 4) 451 -
Property, plant and equipment 59 65
Identifiable intangible assets 55 62
Goodwill 8,053 8,210
Total assets 22,384 25,011
LIABILITIES
Current liabilities
Payables and accrued liabilities (note 7) 2,668 2,966
Provision for restructuring and other costs (note 8) 200 887
Income taxes payable 1,637 1,669
Current portion of deferred revenues 74 74
Current portion of lease liabilities (note 4) 624 -
Current portion of warrant liability (note 9) 420 -
Total current liabilities 5,623 5,596
Deferred revenues 240 258
Lease liabilities (note 4) 718 -
Warrant liability (note 9) 5,275 3,634
Employee future benefits (note 10) 13,647 13,205
Non-current portion of provision for restructuring and other costs (note 8) 441 411
Total liabilities 25,944 23,104
SHAREHOLDERS' (DEFICIENCY) EQUITY
Share capital 222,335 222,335
Other capital 89,437 89,342
Deficit (315,427 ) (309,781 )
Accumulated other comprehensive income 95 11
Total shareholders' (deficiency) equity (3,560 ) 1,907
Total liabilities and shareholders' (deficiency) equity 22,384 25,011
Commitments and contingencies (note 18)
Subsequent events (note 19)
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
Approved by the Board of Directors
/s/ Carolyn Egbert /s/ G rard Limoges
Carolyn Egbert Chair of the Board G rard Limoges Director
Aeterna Zentaris Inc.
Condensed Interim Consolidated Statements of Changes in Shareholders' (Deficiency) Equity
For the three months ended March 31, 2019 and 2018
(in thousands of US dollars, except share data)
(Unaudited) Common shares (number of) 1 Share capital Other capital Deficit Accumulated other comprehensive income (loss) Total
$ $ $ $ $
Balance - January 1, 2019 16,440,760 222,335 89,342 (309,781 ) 11 1,907
Net loss - - - (4,911 ) - (4,911 )
Other comprehensive income (loss):
Foreign currency translation adjustments - - - - 84 84
Actuarial loss on defined benefit plan (note 10) - - - (735 ) - (735 )
Comprehensive income (loss) - - - (5,646 ) 84 (5,562 )
Share-based compensation costs - - 95 - - 95
Balance - March 31, 2019 16,440,760 222,335 89,437 (315,427 ) 95 (3,560 )
(Unaudited) Common shares (number of) 1 Share capital Other capital Deficit Accumulated other comprehensive income (loss) Total
$ $ $ $ $
Balance - January 1, 2018 16,440,760 222,335 88,772 (314,161 ) 271 (2,783 )
Net income - - - 14,424 - 14,424
Other comprehensive income (loss):
Foreign currency translation adjustments - - - - (222 ) (222 )
Comprehensive loss - - - 14,424 (222 ) 14,202
Share-based compensation costs - - 123 - - 123
Balance - March 31, 2018 16,440,760 222,335 88,895 (299,737 ) 49 11,542
_____________________________
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
Aeterna Zentaris Inc.
Condensed Interim Consolidated Statements of Comprehensive (Loss) Income
For the three months ended March 31, 2019 and 2018
(in thousands of US dollars, except share and per share data)
Three months ended March 31,
(Unaudited) 2019 2018
$ $
Revenues
Royalty income (note 5) 13 -
Licensing revenue (note 5) 18 24,568
Sales commission and other 6 90
Total revenues 37 24,658
Operating expenses
Research and development costs 528 833
General and administrative expenses 1,637 2,786
Selling expenses 304 1,641
Impairment of right of use asset (note 4) 337 -
Write-off of other current assets 169 -
Total operating expenses 2,975 5,260
(Loss) income from operations (2,938 ) 19,398
Gain due to changes in foreign currency exchange rates 64 48
Fair value (loss) gain on warrant liability (note 9) (2,061 ) 1,828
Other finance income 24 18
Net finance (loss) income (1,973 ) 1,894
(Loss) income before income taxes (4,911 ) 21,292
Income tax expense - (6,868 )
Net (loss) income (4,911 ) 14,424
Other comprehensive (loss) income:
Items that may be reclassified subsequently to profit or loss:
Foreign currency translation adjustments 84 (222 )
Items that will not be reclassified to profit or loss:
Actuarial loss on defined benefit plans (735 ) -
Comprehensive (loss) income (5,562 ) 14,202
Net (loss) income per share [basic] (0.30 ) 0.88
Net (loss) income per share [diluted] (0.30 ) 0.87
Weighted average number of shares outstanding (note 17):
Basic 16,440,760 16,440,760
Diluted 16,440,760 16,493,363
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
Aeterna Zentaris Inc.
Condensed Interim Consolidated Statements of Cash Flows
For the three months ended March 31, 2019 and 2018
(in thousands of US dollars)
Three months ended March 31,
(Unaudited) 2019 2018
$ $
Cash flows from operating activities
Net (loss) income for the period (4,911 ) 14,424
Items not affecting cash and cash equivalents:
Change in fair value of warrant liability (note 9) 2,061 (1,828 )
Provision for restructuring costs (note 8) (17 ) (219 )
Depreciation and amortization 66 14
Impairment of right of use asset (note 4) 337 -
Write-off of other current assets 169 -
Deferred income taxes - 3,479
Share-based compensation costs 95 123
Employee future benefits (note 10) 134 78
Amortization of deferred revenues (18 ) (541 )
Foreign exchange loss (gain) on items denominated in foreign currencies (45 ) (100 )
(Gain) loss on disposal of property, plant and equipment (3 ) 9
Other non-cash items - 16
Changes in operating assets and liabilities (note 13) (874 ) 1,262
Net cash (used in) provided by operating activities (3,006 ) 16,717
Cash flows from financing activities
Payments on lease liabilities (151 ) -
Net cash provided by financing activities (151 ) -
Cash flows from investing activities
Proceeds from disposal of property, plant and equipment - 11
Change in restricted cash equivalents 50 -
Net cash provided by investing activities 50 11
Effect of exchange rate changes on cash and cash equivalents (48 ) 40
Net change in cash and cash equivalents (3,155 ) 16,768
Cash and cash equivalents - Beginning of period 14,512 7,780
Cash and cash equivalents - End of period 11,357 24,548
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
Aeterna Zentaris Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)
As at March 31, 2019 and for the three months ended March 31, 2019 and 2018
(tabular amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted)
1 Summary of business and basis of preparation
Aeterna Zentaris Inc. ("Aeterna Zentaris" or the "Company") is a specialty biopharmaceutical company which is commercializing novel pharmaceutical therapies. On December 20, 2017, the United States Food and Drug Administration ("FDA") granted marketing approval for Macrilen (macimorelin) to be used in the diagnosis of patients with adult growth hormone deficiency ("AGHD"). On January 16, 2018, the Company, through Aeterna Zentaris GmbH, entered into a license and assignment agreement with Strongbridge Ireland Limited ("Strongbridge") to carry out development, manufacturing, registration, regulatory and supply chain services for the commercialization of Macrilen (macimorelin) in the United States and Canada (the "License and Assignment Agreement"). Effective December 19, 2018, Strongbridge was sold to Novo Nordisk A/S ("Novo").
Basis of presentation
These unaudited condensed interim consolidated financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB") applicable to the preparation of interim financial statements, including IAS 34, Interim Financial Reporting. These unaudited condensed interim consolidated financial statements should be read in conjunction with the Company's annual consolidated financial statements as at and for the year ended December 31, 2018.
The accounting policies in these condensed interim consolidated financial statements are consistent with those presented in the Company's annual consolidated financial statements, except for the adoption, of IFRS 16, Leases, effective January 1, 2019. See note 4 for the impact of the adoption of IFRS 16.
These unaudited condensed interim consolidated financial statements were approved by the Company's Board of Directors on May 7, 2019
These unaudited condensed interim consolidated financial statements were prepared on a going concern basis.
2 Assessment of liquidity and management's plans
Since inception, the Company has incurred significant expenses in its efforts to develop and commercialize products. Consequently, the Company has incurred operating losses and negative cash flow from operations historically and in each of the last several years except for the year ended December 31, 2018 when the Company earned revenue from the sale of a license for the adult indication of MacrilenTM (macimorelin) in the United States and Canada (note 5). As at March 31, 2019, the Company had an accumulated deficit of $315 million.
The Company has $11,357 of cash and cash equivalents as at March 31, 2019, and management believes it has sufficient liquidity to meet its current obligations of $5,623 and continue its planned level of expenses for at least, but not limited to the next twelve months from the date of issuance of these unaudited condensed interim consolidated financial statements. The Company is focused on managing its operating expenses, and has the discretion to limit research and development costs, administrative expenses and capital expenditures in order to maintain its liquidity, until such time that additional sources of funding can be obtained. The Company's principal focus is on the licensing and development of MacrilenTM (macimorelin) and it currently does not have any other approved product. Under the terms of License and Assignment Agreement, Novo is funding 70% of the pediatric clinical trial submitted to the EMA and FDA, the Company's sole development priority.
On March 12, 2019, the Company announced that its board of directors has formed a special committee of independent directors (the "Special Committee") to review strategic options available to the Company. The Special Committee has approved the engagement by the Company of a financial advisor that is working with management to assist the Special Committee and the board of directors in considering a wide range of transactions (including opportunities for the license of MacrilenTM (macimorelin) outside of the United States and Canada, or other monetization transactions relating to
Aeterna Zentaris Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)
As at March 31, 2019 and for the three months ended March 31, 2019 and 2018
(tabular amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted)
MacrilenTM (macimorelin). Management has evaluated whether material uncertainties exist relating to events or conditions and has considered the following in making that critical judgment.
The Company's current operating budget and cash flows from operating activities in 2019 are expected to decline compared with 2018; however, the Company believes its forecasted cash flows will provide sufficient liquidity to finance operations and meet its commitments for at least, but not limited to, twelve months from the date of approval of these unaudited condensed interim consolidated financial statements.
3 Critical accounting estimates and judgments
The preparation of condensed interim consolidated financial statements in accordance with IFRS requires management to make judgments, estimates and assumptions that affect the reported amounts of the Company's assets, liabilities, revenues, expenses and related disclosures. Judgments, estimates and assumptions are based on historical experience, expectations, current trends and other factors that management believes to be relevant at the time at which the Company's condensed interim consolidated financial statements are prepared.
Management reviews, on a regular basis, the Company's accounting policies, assumptions, estimates and judgments in order to ensure that the condensed interim consolidated financial statements are presented fairly and in accordance with IFRS. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Critical accounting estimates and assumptions, as well as critical judgments used in applying accounting policies in the preparation of the Company's condensed interim consolidated financial statements, were the same as those found in note 4 to the Company's annual consolidated financial statements as of December 31, 2018 and 2017 and for the years ended December 31, 2018, and 2017 except for those related to the adoption of IFRS 16, as follows:
Critical judgments in determining the lease term and discount rate
In determining the lease term, management considers all facts and circumstances that create an economic incentive to exercise an extension option, or not exercise a termination option. Extension options (or periods after termination options) are only included in the lease term if the lease is reasonably certain to be extended (or not terminated).
In determining the appropriate discount rate, management identified the rate for the building based on the type and location of the Company's office, laboratory and storage facility in Frankfurt and, for vehicle and equipment leases, used the risk-free rate, credit spread and lease specific adjustment for similar assets.
4 Recent accounting pronouncements
Impact of adoption significant new IFRS standards in 2019
The following new IFRS standards have been adopted by the Company effective January 1, 2019:
The Company has adopted IFRS 16 on a modified retrospective basis from January 1, 2019 with no restatement of comparatives, as permitted under the specific transitional provisions in the standard.
(i) Adjustments recognized on adoption of IFRS 16
The Company has operating leases for building, cars and equipment leases at its location in Frankfurt. Upon adoption of IFRS 16, the Company recognized lease liabilities in relation to leases which had previously been classified as operating leases' under the principles of IAS 17 Leases. Under IFRS 16, these liabilities were measured at the present value of the remaining lease payments excluding renewal options as they are not expected to be exercised, discounted using the Company's incremental borrowing rate as of January 1, 2019. The Company's incremental annual borrowing rate applied to the lease liabilities on January 1, 2019 were:
Aeterna Zentaris Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)
As at March 31, 2019 and for the three months ended March 31, 2019 and 2018
(tabular amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted)
Car leases ranging from 4.84% to 5.32%
Equipment leases 3.88%
The weighted average incremental borrowing rate applied to lease liabilities recognized in the statement of financial position at January 1, 2019 was 5.45%.
2019
Operating lease commitments disclosed as at December 31, 2018 1,620
Discounted using the lessee's incremental borrowing rate of at the date of initial application:
Lease liability recognized as at January 1, 2019 1,522
Current lease liabilities 629
Non-current lease liabilities 893
During the three-month period ended March 31, 2019
Cash lease payments made 171
Interest paid as charged to comprehensive income (loss) as other finance income 20
Payments against lease liabilites 151
Lease liability recognized as at March 31, 2019 1,342
Current lease liabilities 624
Non-current lease liabilities 718
The Company's lease liabilities come due, as at March 31, 2019, as follows:
$
Less than 1 year 624
1 - 3 years 704
4 - 5 years 14
More than 5 years -
Total 1,342
The Company's related right of use assets were measured at the amount equal to the lease liability at the date of initial application. Only the building right of use asset was further adjusted by the application of $663 in related onerous lease provision to the value at inception.
Aeterna Zentaris Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)
As at March 31, 2019 and for the three months ended March 31, 2019 and 2018
(tabular amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted)
March 31, January 1,
2019 2019
Gross right of use assets
Building 383 735
Cars and equipment 122 124
Total 505 859
Accumulated amortization
Building (41) -
Cars and equipment (13) -
Total (54) -
Net right of use assets
Building 342 735
Cars and equipment 109 124
Total 451 859
During the three-month period ended March 31, 2019, management continued its search for a sub-lessee. However, there have been delays which led to a reassessment of its onerous lease provision as the Company has determined that its plan to exit its building lease, in full, as at December 31, 2019 was not probable. As such, the Company recognized an impairment of its right of use building asset of $337 in the statement of comprehensive income and loss.
Overall impact from adoption
The change in accounting policy affected the following items in the balance sheet on January 1, 2019:
Right to use assets - increase by $859
Onerous lease contracts - decrease by $663
Lease liabilities - increase by $1,522
Loss per share for the three months to March 31, 2019 was not affected as a result of the adoption of IFRS 16.
(ii) Practical expedients applied
In applying IFRS 16 for the first time, the Company has used the following practical expedients permitted by the standard:
the use of a single discount rate to a portfolio of leases with reasonably similar characteristics
reliance on previous assessments on whether leases are onerous;
the exclusion of initial direct costs for the measurement of the right of use asset at the date of initial application; and
the use of hindsight in determining the lease term where the contract contains options to extend or terminate the lease.
The Company has also elected not to reassess whether a contract is or contains a lease at the date of initial application. Instead, for contracts entered into before the transition date, the Company relied on its assessment made applying IAS 17 and IFRIC 4 Determining whether an Arrangement contains a Lease.
(iii) The Company's leasing activities and how these are accounted for
The Company leases various office and lab premises (building), cars and equipment. The building lease was originally for 10 years with one five-year extension, such extension is ending on April 30, 2021. Car lease contracts are typically made for fixed periods of three to four years while the equipment lease is for five years ending April 30, 2020. Lease terms are negotiated on an individual basis and contain a wide range of different terms and conditions. and the lease agreements do not impose any covenants, but leased assets may not be used as security for borrowing purposes.
Aeterna Zentaris Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)
As at March 31, 2019 and for the three months ended March 31, 2019 and 2018
(tabular amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted)
Until the 2018 financial year, leases of property, plant and equipment were classified as operating leases. Payments made under operating leases (net of any incentives received from the lessor) were charged to profit or loss on a straight-line basis over the period of the lease.
From January 1, 2019, leases are recognized as a right of use asset and a corresponding liability at the date at which the leased asset is available for use by the Company. Each lease payment is allocated between the liability and finance cost. The finance cost is charged to comprehensive profit or loss over the lease period so as to produce a constant periodic rate of interest on the remaining balance of the liability for each period. The right of use assets are measured at cost and are depreciated over the shorter of the assets' useful life and the lease terms on a straight-line basis, less any accumulated impairment losses and adjusted for any remeasurement of the lease liability.
Assets and liabilities arising from a lease are initially measured on a present value basis. Lease liabilities include the net present value of its fixed payments (including in-substance fixed payments), less any lease incentives receivable
The lease payments are discounted using the interest rate implicit in the lease. If that rate cannot be determined, the lessee's incremental borrowing rate is used, being the rate that the lessee would have to pay to borrow the funds necessary to obtain an asset of similar value in a similar economic environment with similar terms and conditions.
Right of use assets are measured at cost comprising the following:
the amount of the initial measurement of lease liability;
any lease payments made at or before the commencement date less any lease incentives received;
any initial direct costs;
onerous lease provisions as previously determined (note 8); and
any restoration costs.
Payments associated with short-term leases and leases of low-value assets are recognized on a straight-line basis as an expense in the statement of comprehensive profit or loss.
B) IFRIC 23, "Uncertainty over Income Tax Treatment" ("IFRIC 23")
In June 2017, IFRIC 23, was issued and it provides guidance on how to value uncertain income tax positions based on the probability of whether the relevant tax authorities will accept the company's tax treatments. A company is to assume that a taxation authority with the right to examine any amounts reported to it will examine those amounts and will have full knowledge of all relevant information when doing so. IFRIC 23 is effective for annual periods beginning on or after January 1, 2019. The adoption of this interpretation did not have a significant impact on the Company's condensed interim consolidated financial statements.
C) Amendments in Plan Amendment, Curtailment or Settlement (Amendments to IAS 19)
In June 2015, the IASB published ED/2015/5 Remeasurement on a Plan Amendment, Curtailment or Settlement/Availability of a Refund from a Defined Benefit Plan (Proposed amendments to IAS 19 and IFRIC 14) combining two issues submitted separately to the IFRS Interpretations Committee into a single package of narrow-scope amendments to IAS 19 Employee Benefits and IFRIC 14 IAS 19 - The Limit on a Defined Benefit Asset, Minimum Funding Requirements and their Interaction. However, in April 2017 the IASB decided to pursue the amendments to IAS 19 and in September 2017 confirmed it would do so despite putting off the amendments to IFRIC 14. The amendments in Plan Amendment, Curtailment or Settlement (Amendments to IAS 19) are: (i) if a plan amendment, curtailment or settlement occurs, it is now mandatory that the current service cost and the net interest for the period after the remeasurement are determined using the assumptions used for the remeasurement and (ii) amendments have been included to clarify the effect of a plan amendment, curtailment or settlement on the requirements regarding the asset ceiling. An entity applies the amendments to plan amendments, curtailments or settlements occurring on or after the beginning of the first annual reporting period that begins on or after January 1, 2019. The adoption of these amendments did not have a significant impact on the Company's condensed interim consolidated financial statements.
Aeterna Zentaris Inc.
Notes to Condensed Interim Consolidated Financial Statements (Unaudited)
As at March 31, 2019 and for the three months ended March 31, 2019 and 2018
(tabular amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted)
5 Licensing arrangement
On January 16, 2018, the Company, through Aeterna Zentaris GmbH, entered into the License and Assignment Agreement with Strongbridge to carry out development, manufacturing, registration, regulatory and supply chain services for the commercialization of Macrilen (macimorelin) in the United States and Canada, which provides for (i) the "right to use" license relating to the Adult Indication; (ii) the sale of the right to acquire a license of a future FDA-approved Pediatric Indication; (iii) Strongbridge has agreed to fund 70% of the costs of a pediatric clinical trial submitted for approval to the EMA and FDA to be run by the Company with customary oversight from a joint steering committee; and (iv) for an Interim Supply Arrangement. Effective December 19, 2018, Strongbridge sold the entity which owned the License and Assignment Agreement for the United States and Canadian rights to Macrilen to Novo.
Royalty income earned under the License and Assignment Agreement for the first quarter of 2019 was $13 (2018- $nil). During the first quarter of 2019, the Company recognized a receivable from Novo of $308 for its share of PIP study costs.
6 Trade and other receivables
March 31, December 31,
2019 2018
$ $
Trade accounts receivable (net of allowance for doubtful accounts of $55 (December 31, 2018 - $55) 313 142
Value added tax 284 49
Other 15 103
612 294
Last updated: May 7, 2019