Full Press Release Details
Interim Consolidated Financial Statements
at September 30, 2019 and for the three-month and nine-month periods ended September 30, 2019 and 2018 (presented in
thousands of US dollars)
at September 30, 2019 and for the three-month and nine-month period ended September 30, 2019 and 2018
Interim Consolidated Financial Statements
| Condensed Interim Consolidated Statements of Financial Position | 3 |
| Condensed Interim Consolidated Statements of Changes in Shareholders' (Deficiency) Equity | 5 |
| Condensed Interim Consolidated Statements of Comprehensive Income (Loss) | 7 |
| Condensed Interim Consolidated Statements of Cash Flows | 8 |
| Notes to Condensed Interim Consolidated Financial Statements | 9 |
| Aeterna Zentaris Inc. |
| Condensed Interim Consolidated Statements of Financial Position |
| (in thousands of US dollars) | ||||||||
| ( Unaudited ) | September 30, 2019 | December 31, 2018 | ||||||
| $ | $ | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | 10,862 | 14,512 | ||||||
| Trade and other receivables (note 6) | 587 | 294 | ||||||
| Inventory | 582 | 240 | ||||||
| Prepaid expenses and other current assets | 762 | 1,210 | ||||||
| Total current assets | 12,793 | 16,256 | ||||||
| Restricted cash | 356 | 418 | ||||||
| Right of use assets (note 4) | 418 | - | ||||||
| Property, plant and equipment | 42 | 65 | ||||||
| Identifiable intangible assets | 44 | 62 | ||||||
| Goodwill | 7,849 | 8,210 | ||||||
| Total assets | 21,502 | 25,011 | ||||||
| LIABILITIES | ||||||||
| Current liabilities | ||||||||
| Payables and accrued liabilities (note 7) | 2,279 | 2,966 | ||||||
| Provision for restructuring and other costs (note 8) | 877 | 887 | ||||||
| Income taxes payable | 1,595 | 1,669 | ||||||
| Current portion of deferred revenues | 74 | 74 | ||||||
| Current portion of lease liabilities (note 4) | 629 | - | ||||||
| Current portion of warrant liability (note 9) | 14 | - | ||||||
| Total current liabilities | 5,468 | 5,596 | ||||||
| Deferred revenues | 203 | 258 | ||||||
| Lease liabilities (note 4) | 408 | - | ||||||
| Warrant liability (note 9) | 2,774 | 3,634 | ||||||
| Employee future benefits (note 10) | 14,477 | 13,205 | ||||||
| Non-current portion of provision for restructuring and other costs (note 8) | 365 | 411 | ||||||
| Total liabilities | 23,695 | 23,104 | ||||||
| SHAREHOLDERS' (DEFICIENCY) EQUITY | ||||||||
| Share capital | 224,531 | 222,335 | ||||||
| Other capital | 89,758 | 89,342 | ||||||
| Deficit | (316,844 | ) | (309,781 | ) | ||||
| Accumulated other comprehensive income | 362 | 11 | ||||||
| Total shareholders' (deficiency) equity | (2,193 | ) | 1,907 | |||||
| Total liabilities and shareholders' (deficiency) equity | 21,502 | 25,011 |
and contingencies (note 18)
accompanying notes are an integral part of these condensed interim consolidated financial statements.
| Aeterna Zentaris Inc. |
| Condensed Interim Consolidated Statements of Financial Position |
by the Board of Directors
| /s/ Carolyn Egbert | /s/ G rard Limoges | |
| Carolyn Egbert Chair of the Board | Gerard Limoges Director |
| Aeterna Zentaris Inc. |
| Condensed Interim Consolidated Statements of Changes in Shareholders' (Deficiency) Equity |
| For the three and nine months ended September 30, 2019 and 2018 |
| (in thousands of US dollars, except share data) | ||||||||||||||||||||||||
| (Unaudited) | Common shares (number of) | Share capital | Other capital | Deficit | Accumulated other comprehensive income | Total | ||||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||||||
| Balance - July1, 2019 | 16,632,410 | 223,140 | 89,824 | (315,977 | ) | (15) | (3,028 | ) | ||||||||||||||||
| Net (loss) | - | - | - | (331) | - | (331 | ) | |||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | 377 | 377 | ||||||||||||||||||
| Actuarial loss on defined benefit plan (note 10) | - | - | - | (536 | ) | - | (536 | ) | ||||||||||||||||
| Comprehensive (loss) | - | - | - | (867 | ) | 377 | (490 | ) | ||||||||||||||||
| Issuance of common shares and warrants, net (notes 9 and 11) | 3,325,000 | 1,290 | - | - | - | 1,290 | ||||||||||||||||||
| Exercise of deferred share units (note 11) | 37,100 | 101 | (121) | - | - | (20 | ) | |||||||||||||||||
| Share-based compensation costs | - | - | 55 | - | - | 55 | ||||||||||||||||||
| Balance - September 30, 2019 | 19,994,510 | 224,531 | 89,758 | (316,844 | ) | 362 | (2,193 | ) |
| (Unaudited) | Common shares (number of) | Share capital | Other capital | Deficit | Accumulated other comprehensive income | Total | ||||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||||||
| Balance - July 1, 2018 | 16,440,760 | 222,335 | 89,288 | (302,134 | ) | 21 | 9,510 | |||||||||||||||||
| Net income | - | - | - | (2,509 | ) | - | (2,509 | ) | ||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | 3 | 3 | ||||||||||||||||||
| Actuarial gain on defined benefit plan (note 10) | - | - | - | 406 | - | 406 | ||||||||||||||||||
| Comprehensive income (loss) | - | - | - | (2,103 | ) | 3 | (2,100 | ) | ||||||||||||||||
| Share-based compensation costs | - | - | - | - | - | - | ||||||||||||||||||
| Balance - September 30, 2018 | 16,440,760 | 222,335 | 89,288 | (304,237 | ) | 24 | 7,410 |
accompanying notes are an integral part of these condensed interim consolidated financial statements.
| Aeterna Zentaris Inc. |
| Condensed Interim Consolidated Statements of Changes in Shareholders' (Deficiency) Equity |
| For the three and nine months ended September 30, 2019 and 2018 |
| (in thousands of US dollars, except share data) | ||||||||||||||||||||||||
| (Unaudited) | Common shares (number of) | Share capital | Other capital | Deficit | Accumulated other comprehensive income | Total | ||||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||||||
| Balance - January 1, 2019 | 16,440,760 | 222,335 | 89,342 | (309,781 | ) | 11 | 1,907 | |||||||||||||||||
| Net (loss) | - | - | - | (5,036 | ) | - | (5,036 | ) | ||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | 351 | 351 | ||||||||||||||||||
| Actuarial loss on defined benefit plan (note 10) | - | - | - | (2,027 | ) | - | (2,027 | ) | ||||||||||||||||
| Comprehensive (loss) | - | - | - | (7,063 | ) | 351 | (6,712 | ) | ||||||||||||||||
| Exercise of warrants, stock options and deferred share units (notes 9 and 11) | 228,750 | 906 | (329 | ) | - | - | 577 | |||||||||||||||||
| Issuance of common shares and warrants, net (notes 9 and 11) | 3,325,000 | 1,290 | - | - | - | 1,290 | ||||||||||||||||||
| Share-based compensation costs | - | - | 745 | - | - | 745 | ||||||||||||||||||
| Balance - September 30, 2019 | 19,994,510 | 224,531 | 89,758 | (316,844 | ) | 362 | (2,193 | ) |
| (Unaudited) | Common shares (number of) | Share capital | Other capital | Deficit | Accumulated other comprehensive income | Total | ||||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||||||
| Balance - January 1, 2018 | 16,440,760 | 222,335 | 88,772 | (314,161 | ) | 271 | (2,783 | ) | ||||||||||||||||
| Net income | - | - | - | 9,313 | - | 9,313 | ||||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | (247 | ) | (247 | ) | ||||||||||||||||
| Actuarial gain on defined benefit plan (note 10) | - | - | - | 611 | - | 611 | ||||||||||||||||||
| Comprehensive income (loss) | - | - | - | 9,924 | (247 | ) | 9,677 | |||||||||||||||||
| Share-based compensation costs | - | - | 516 | - | - | 516 | ||||||||||||||||||
| Balance - September 30, 2018 | 16,440,760 | 222,335 | 89,288 | (304,237 | ) | 24 | 7,410 |
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 and nine months ended September 30, 2019 and 2018 |
| (in thousands of US dollars, except share and per share data) | ||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| (Unaudited) | 2019 | 2018 | 2019 | 2018 | ||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Revenues | ||||||||||||||||
| Royalty income (note 5) | 8 | - | 29 | - | ||||||||||||
| Product sales (note 5) | - | 663 | 129 | 721 | ||||||||||||
| Sales commission and other | 256 | - | 301 | 111 | ||||||||||||
| Licensing revenue (note 5) | 19 | - | 55 | 24,657 | ||||||||||||
| Total revenues | 283 | 663 | 514 | 25,489 | ||||||||||||
| Cost of goods sold | - | 494 | 101 | 691 | ||||||||||||
| Gross income | 283 | 169 | 413 | 24,798 | ||||||||||||
| Research and development costs | 475 | 358 | 1,574 | 2,165 | ||||||||||||
| General and administrative expenses | 1,364 | 2,439 | 4,924 | 7,229 | ||||||||||||
| Selling expenses | 377 | 383 | 1,176 | 2,521 | ||||||||||||
| Restructuring costs (note 8) | - | - | 773 | - | ||||||||||||
| Impairment (reversal) of right of use asset (note 4) | (125 | ) | - | 276 | - | |||||||||||
| Write-off of other current assets | - | - | 169 | - | ||||||||||||
| Total operating expenses (note 12) | 2,091 | 3,180 | 8,892 | 11,915 | ||||||||||||
| (Loss) income from operations | (1,808 | ) | (3,011 | ) | (8,479 | ) | 12,883 | |||||||||
| Gain (loss) due to changes in foreign currency exchange rates | 3 | (133 | ) | 61 | 592 | |||||||||||
| Change in fair value of warrant liability (note 9) | 2,120 | 58 | 3,985 | 1,752 | ||||||||||||
| Other finance (costs) income | (646 | ) | 30 | (603 | ) | 174 | ||||||||||
| Net finance income (costs) | 1,477 | (45 | ) | 3,443 | 2,518 | |||||||||||
| Income (loss) before income taxes | (331 | ) | (3,056 | ) | (5,036 | ) | 15,401 | |||||||||
| Income tax recovery (expense) | - | 547 | - | (6,088 | ) | |||||||||||
| Net (loss) income | (331 | ) | (2,509 | ) | (5,036 | ) | 9,313 | |||||||||
| Other comprehensive (loss) income: | ||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||
| Foreign currency translation adjustments | 377 | 3 | 351 | (247 | ) | |||||||||||
| Items that will not be reclassified to profit or loss: | ||||||||||||||||
| Actuarial (gain) loss on defined benefit plans | (536 | ) | 406 | (2,027 | ) | 611 | ||||||||||
| Comprehensive (loss) income | (490 | ) | (2,100 | ) | (6,712 | ) | 9,677 | |||||||||
| Net (loss) income per share [basic] | (0.02 | ) | (0.15 | ) | (0.31 | ) | 0.57 | |||||||||
| Net (loss) income per share [diluted] | (0.02 | ) | (0.15 | ) | (0.31 | ) | 0.56 | |||||||||
| Weighted average number of shares outstanding (note 17): | ||||||||||||||||
| Basic | 16,887,819 | 16,440,760 | 16,651,969 | 16,440,760 | ||||||||||||
| Diluted | 16,887,819 | 16,440,760 | 16,651,969 | 16,655,576 |
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 and nine months ended September 30, 2019 and 2018 |
| (in thousands of US dollars, except share and per share data) | ||||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| (Unaudited) | 2019 | 2018 | 2019 | 2018 | ||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Cash flows from operating activities | ||||||||||||||||
| Net (loss) income for the period | (331 | ) | (2,509 | ) | (5,036 | ) | 9,313 | |||||||||
| Items not affecting cash and cash equivalents: | ||||||||||||||||
| Change in fair value of warrant liability (note 9) | (2,120 | ) | (57 | ) | (3,985 | ) | (1,752 | ) | ||||||||
| Transaction costs of warrants issued expensed as finance cost | 545 | - | 545 | - | ||||||||||||
| Provision for restructuring costs (note 8) | - | (120 | ) | 773 | (339 | ) | ||||||||||
| Depreciation and amortization | 119 | 12 | 255 | 47 | ||||||||||||
| Impairment (reversal) of right of use asset (note 4) | (125 | ) | - | 276 | - | |||||||||||
| Write-off of current assets | - | - | 169 | - | ||||||||||||
| Deferred income taxes | - | - | - | 3,479 | ||||||||||||
| Share-based compensation costs | 55 | 1 | 745 | 516 | ||||||||||||
| Employee future benefits (note 10) | 60 | 12 | 196 | (221 | ) | |||||||||||
| Amortization of deferred revenues | (19 | ) | - | (55 | ) | (541 | ) | |||||||||
| Foreign exchange loss on items denominated in foreign currencies | (12 | ) | 140 | (61 | ) | (583 | ) | |||||||||
| (Gain) loss on disposal of long-term assets | (3 | ) | - | (6 | ) | 9 | ||||||||||
| Other non-cash items | - | 2 | - | 26 | ||||||||||||
| Interest accretion on lease liability (note 4) | (15 | ) | - | (53 | ) | - | ||||||||||
| Changes in operating assets and liabilities (note 13) | (749 | ) | 84 | (1,534 | ) | (450 | ) | |||||||||
| Net cash (used in) provided by operating activities | (2,595 | ) | (2,435 | ) | (7,771 | ) | 9,504 | |||||||||
| Cash flows from financing activities | ||||||||||||||||
| Issuance of common shares and warrants (notes 9 and 11) | 4,988 | - | 4,988 | - | ||||||||||||
| Transaction costs | (786 | ) | - | (786 | ) | - | ||||||||||
| Proceeds from exercise of warrants, options and deferred share units (notes 9 and 11) | - | - | 314 | - | ||||||||||||
| Payments on lease liability (note 4) | (152 | ) | - | (462 | ) | - | ||||||||||
| Net cash from financing activities | 4,050 | - | 4,054 | - | ||||||||||||
| Cash flows from investing activities | ||||||||||||||||
| Disposal of property, plant and equipment | - | - | - | 11 | ||||||||||||
| Change in restricted cash | - | (50 | ) | 50 | (50 | ) | ||||||||||
| Net cash from investing activities | - | (50 | ) | 50 | (39 | ) | ||||||||||
| Effect of exchange rate changes on cash and cash equivalents | (276 | ) | (661 | ) | 17 | (445 | ) | |||||||||
| Net change in cash and cash equivalents | 1,179 | (3,146 | ) | (3,650 | ) | 9,020 | ||||||||||
| Cash and cash equivalents - Beginning of period | 9,683 | 19,946 | 14,512 | 7,780 | ||||||||||||
| Cash and cash equivalents - End of period | 10,862 | 16,800 | 10,862 | 16,800 |
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 September 30, 2019 and for the three and nine months ended September 30, 2019 and 2018 |
| (amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
Zentaris Inc. ("Aeterna Zentaris" or the "Company") has incurred significant expenses in its efforts to
develop and co-promote 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 Macrilen (macimorelin) in the United States and Canada (note 5).
As at September 30, 2019, the Company had an accumulated deficit of $317 million. The Company also had a net loss of $5,036 for
the nine months ended September 30, 2019, and negative cash flow from operations of $7,771 in this period.
Company's principal focus is on the licensing and development of Macrilen (macimorelin) and it currently does not
have any other approved products. Under the terms of License and Assignment Agreement (as defined below), Novo Nordisk A/S ("Novo")
is funding 70% of the pediatric clinical trial submitted to the EMA and FDA, the Company's sole development activity.
March 12, 2019, the Company announced that its board of directors formed a special committee of independent directors (the "Special
Committee") to review strategic options available to the Company and the engagement of Torreya, its financial advisor. In
October 2019, the Company ended its arrangement with Torreya and re-commenced business development activities on its own. Based
on the contract with Torreya, should the Company agree to license macimorelin to certain companies in a defined period of time
after the cancellation of the contract the Company would owe a fee to Torreya
has evaluated whether material uncertainties exist relating to events or conditions and has considered the following in making
that critical judgment.
ability of the Company to realize its assets and meet its obligations as they come due is dependent on earning sufficient revenues
under the License and Assignment Agreement, developing opportunities for Macrilen (macimorelin) in the rest of the world,
realizing other monetizing transactions, and raising additional sources of funding, the outcome of which cannot be predicted at
this time. The revenue provided under the License and Assignment Agreement was $29 for the nine months ended September 30, 2019
and as at September 30, 2019, the Company had cash of $10,862. In September 2019, the Company closed an equity financing which
provided $4,202 in net cash proceeds.
significant portion of the Company's cash is held in Aeterna Zentaris GmbH ("AEZS Germany"), our wholly owned
German subsidiary. AEZS Germany is also the counter-party for revenue earned under the License and Assignment Agreement. If and
when current and medium term liabilities of AEZS Germany exceed the values ascribed to AEZS Germany's assets, it may no
longer be possible under applicable German solvency laws for AEZS Germany's operations to continue. The Company has some
discretion to manage research and development costs, administrative expenses and capital expenditures in order to maintain its
cash liquidity; however, the Company will need to conclude agreement(s) for licensing or selling the European or worldwide rights
to Macrilen (macimorelin) and, if necessary, obtain further financing in order to continue its currently planned operations.
has assessed the Company's ability to continue as a going concern and concluded that additional capital will be required.
There can be no assurance that the Company will be able to execute license or purchase agreements or to obtain equity or debt
financing, or on terms acceptable to it. Factors within and outside the Company's control could have a significant bearing
on its ability to obtain additional financing. As a result, management has determined that there are material uncertainties that
may cast significant doubt upon the Company's ability to continue as a going concern.
financial statements have been prepared on a going concern basis, which asserts the Company has the ability in the near term to
continue to realize its assets and discharge its liabilities and commitments in a planned manner giving consideration to the above
and expected possible outcomes. Conversely, if the going concern assumption is not appropriate, adjustments to the carrying amounts
of the Company's assets, liabilities, revenues, expenses and balance sheet classifications may be necessary, and these adjustments
| Aeterna Zentaris Inc. |
| Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
| As at September 30, 2019 and for the three and nine months ended September 30, 2019 and 2018 |
| (amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
Company is a specialty biopharmaceutical company which is commercializing novel pharmaceutical therapies. On December 20, 2017,
the 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 AEZS Germany, 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 sold the United States and Canadian
rights to Macrilen (macimorelin) under the License and Assignment Agreement to Novo.
unaudited condensed interim consolidated financial statements have been prepared in accordance with International Financial Reporting
Standards as issued by the International Accounting Standards Board ("IFRS") 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.
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.
unaudited condensed interim consolidated financial statements were approved by the Company's Board of Directors on November
described in Note 1, these unaudited condensed interim consolidated financial statements were prepared on a going concern basis.
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.
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.
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:
judgments in determining the lease term and discount rate
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).