Full Press Release Details
Interim Consolidated Financial Statements
at June 30, 2019 and for the three-month and six-month periods ended June 30, 2019 and 2018
in thousands of US dollars)
| Aeterna Zentaris Inc. |
| As at June 30, 2019 and for the three-month and six-month period ended June 30, 2019 and 2018 |
| Condensed Interim Consolidated Financial Statements |
| (Unaudited) |
| Condensed Interim Consolidated Statements of Financial Position | 3 |
| Condensed Interim Consolidated Statements of Changes in Shareholders' Equity (Deficiency) | 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 ) | June 30, 2019 | December 31, 2018 | ||||||
| $ | $ | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | 9,683 | 14,512 | ||||||
| Trade and other receivables (note 6) | 494 | 294 | ||||||
| Inventory | 562 | 240 | ||||||
| Prepaid expenses and other current assets | 1,030 | 1,210 | ||||||
| Total current assets | 11,769 | 16,256 | ||||||
| Restricted cash | 367 | 418 | ||||||
| Right of use assets (note 4) | 340 | - | ||||||
| Property, plant and equipment | 48 | 65 | ||||||
| Identifiable intangible assets | 50 | 62 | ||||||
| Goodwill | 8,177 | 8,210 | ||||||
| Total assets | 20,751 | 25,011 | ||||||
| LIABILITIES | ||||||||
| Current liabilities | ||||||||
| Payables and accrued liabilities (note 7) | 3,200 | 2,966 | ||||||
| Provision for restructuring and other costs (note 8) | 1,004 | 887 | ||||||
| Income taxes payable | 1,662 | 1,669 | ||||||
| Current portion of deferred revenues | 74 | 74 | ||||||
| Current portion of lease liabilities (note 4) | 635 | - | ||||||
| Current portion of warrant liability (note 9) | 447 | - | ||||||
| Total current liabilities | 7,022 | 5,596 | ||||||
| Deferred revenues | 222 | 258 | ||||||
| Lease liabilities (note 4) | 570 | - | ||||||
| Warrant liability (note 9) | 1,004 | 3,634 | ||||||
| Employee future benefits (note 10) | 14,561 | 13,205 | ||||||
| Non-current portion of provision for restructuring and other costs (note 8) | 400 | 411 | ||||||
| Total liabilities | 23,779 | 23,104 | ||||||
| SHAREHOLDERS' (DEFICIENCY) EQUITY | ||||||||
| Share capital | 223,140 | 222,335 | ||||||
| Other capital | 89,824 | 89,342 | ||||||
| Deficit | (315,977 | ) | (309,781 | ) | ||||
| Accumulated other comprehensive (loss) income | (15 | ) | 11 | |||||
| Total shareholders' (deficiency) equity | (3,028 | ) | 1,907 | |||||
| Total liabilities and shareholders' (deficiency) equity | 20,751 | 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 | G rard Limoges Director |
| Aeterna Zentaris Inc. |
| Condensed Interim Consolidated Statements of Changes in Shareholders' (Deficiency) Equity |
| For the three and six months ended June 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 (loss) income | Total | ||||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||||||
| Balance - April 1, 2019 | 16,440,760 | 222,335 | 89,437 | (315,427 | ) | 95 | (3,560 | ) | ||||||||||||||||
| Net income | - | - | - | 206 | - | 206 | ||||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | (110 | ) | (110 | ) | ||||||||||||||||
| Actuarial loss on defined benefit plan (note 10) | - | - | - | (756 | ) | - | (756 | ) | ||||||||||||||||
| Comprehensive (loss) | - | - | - | (550 | ) | (110 | ) | (660 | ) | |||||||||||||||
| Issuance of common shares | 191,650 | 805 | - | - | - | 805 | ||||||||||||||||||
| Share-based compensation costs | - | - | 387 | - | - | 387 | ||||||||||||||||||
| Balance - June 30, 2019 | 16,632,410 | 223,140 | 89,824 | (315,977 | ) | (15 | ) | (3,028 | ) |
| (Unaudited) | Common shares (number of) | Share capital | Other capital | Deficit | Accumulated other comprehensive (loss) income | Total | ||||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||||||
| Balance - April 1, 2018 | 16,440,760 | 222,335 | 88,895 | (299,737 | ) | 49 | 11,542 | |||||||||||||||||
| Net income | - | - | - | (2,602 | ) | - | (2,602 | ) | ||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | (28 | ) | (28 | ) | ||||||||||||||||
| Actuarial gain on defined benefit plan (note 10) | - | - | - | 205 | - | 205 | ||||||||||||||||||
| Comprehensive income (loss) | - | - | - | (2,397 | ) | (28 | ) | (2,425 | ) | |||||||||||||||
| Share-based compensation costs | - | - | 393 | - | - | 393 | ||||||||||||||||||
| Balance - June 30, 2018 | 16,440,760 | 222,335 | 89,288 | (302,134 | ) | 21 | 9,510 |
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 six months ended June 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 (loss) income | Total | ||||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||||||
| Balance - January 1, 2019 | 16,440,760 | 222,335 | 89,342 | (309,781 | ) | 11 | 1,907 | |||||||||||||||||
| Net (loss) | - | - | - | (4,705 | ) | - | (4,705 | ) | ||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | (26 | ) | (26 | ) | ||||||||||||||||
| Actuarial loss on defined benefit plan (note 10) | - | - | - | (1,491 | ) | - | (1,491 | ) | ||||||||||||||||
| Comprehensive (loss) | - | - | - | (6,196 | ) | (26 | ) | (6,222 | ) | |||||||||||||||
| Issuance of common shares | 191,650 | 805 | - | - | - | 805 | ||||||||||||||||||
| Share-based compensation costs | - | - | 482 | - | - | 482 | ||||||||||||||||||
| Balance - June 30, 2019 | 16,632,410 | 223,140 | 89,824 | (315,977 | ) | (15 | ) | (3,028 | ) |
| (Unaudited) | Common shares (number of) | Share capital | Other capital | Deficit | Accumulated other comprehensive (loss) income | Total | ||||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||||||
| Balance - January 1, 2018 | 16,440,760 | 222,335 | 88,772 | (314,161 | ) | 271 | (2,783 | ) | ||||||||||||||||
| Net income | - | - | - | 11,822 | - | 11,822 | ||||||||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | (250 | ) | (250 | ) | ||||||||||||||||
| Actuarial gain on defined benefit plan (note 10) | - | - | - | 205 | - | 205 | ||||||||||||||||||
| Comprehensive income (loss) | - | - | - | 12,027 | (250 | ) | 11,777 | |||||||||||||||||
| Share-based compensation costs | - | - | 516 | - | - | 516 | ||||||||||||||||||
| Balance - June 30, 2018 | 16,440,760 | 222,335 | 89,288 | (302,134 | ) | 21 | 9,510 |
accompanying notes are an integral part of these condensed interim consolidated financial statements.
| Aeterna Zentaris Inc. |
| Condensed Interim Consolidated Statements of Comprehensive Income (Loss) |
| For the three and six months ended June 30, 2019 and 2018 |
| (in thousands of US dollars, except share and per share data) | ||||||||||||||||
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| (Unaudited) | 2019 | 2018 | 2019 | 2018 | ||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Revenues | ||||||||||||||||
| Royalty income (note 5) | 8 | - | 21 | - | ||||||||||||
| Product sales (note 5) | 129 | - | 129 | - | ||||||||||||
| Sales commission and other | 39 | 79 | 45 | 169 | ||||||||||||
| Licensing revenue (note 5) | 18 | 89 | 36 | 24,657 | ||||||||||||
| Total revenues | 194 | 168 | 231 | 24,826 | ||||||||||||
| Cost of goods sold | 101 | 197 | 101 | 197 | ||||||||||||
| Gross income (loss) | 93 | (29 | ) | 130 | 24,629 | |||||||||||
| Research and development costs | 571 | 974 | 1,099 | 1,807 | ||||||||||||
| General and administrative expenses | 1,923 | 2,004 | 3,560 | 4,790 | ||||||||||||
| Selling expenses | 495 | 497 | 799 | 2,138 | ||||||||||||
| Restructuring costs (note 8) | 773 | - | 773 | - | ||||||||||||
| Impairment of right of use asset (note 4) | 64 | - | 401 | - | ||||||||||||
| Write-off of other current assets | - | - | 169 | - | ||||||||||||
| Total operating expenses | 3,826 | 3,475 | 6,801 | 8,735 | ||||||||||||
| (Loss) income from operations | (3,733 | ) | (3,504 | ) | (6,671 | ) | 15,894 | |||||||||
| (Loss) gain due to changes in foreign currency exchange rates | (6 | ) | 677 | 58 | 725 | |||||||||||
| Change in fair value of warrant liability (note 9) | 3,926 | (134 | ) | 1,865 | 1,694 | |||||||||||
| Other finance income | 19 | 126 | 43 | 144 | ||||||||||||
| Net finance income | 3,939 | 669 | 1,966 | 2,563 | ||||||||||||
| Income (loss) before income taxes | 206 | (2,835 | ) | (4,705 | ) | 18,457 | ||||||||||
| Income tax recovery (expense) | - | 233 | - | (6,635 | ) | |||||||||||
| Net income (loss) | 206 | (2,602 | ) | (4,705 | ) | 11,822 | ||||||||||
| Other comprehensive (loss) income: | ||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||
| Foreign currency translation adjustments | (110 | ) | (28 | ) | (26 | ) | (250 | ) | ||||||||
| Items that will not be reclassified to profit or loss: | ||||||||||||||||
| Actuarial loss (gain) on defined benefit plans | (756 | ) | 205 | (1,491 | ) | 205 | ||||||||||
| Comprehensive (loss) income | (660 | ) | (2,425 | ) | (6,222 | ) | 11,777 | |||||||||
| Net (loss) income per share [basic] | 0.01 | (0.16 | ) | (0.28 | ) | 0.72 | ||||||||||
| Net (loss) income per share [diluted] | 0.01 | (0.16 | ) | (0.28 | ) | 0.70 | ||||||||||
| Weighted average number of shares outstanding (note 17): | ||||||||||||||||
| Basic | 16,622,415 | 16,440,760 | 16,532,090 | 16,440,760 | ||||||||||||
| Diluted | 17,260,016 | 16,440,760 | 16,532,090 | 16,489,364 |
accompanying notes are an integral part of these condensed interim consolidated financial statements.
| Aeterna Zentaris Inc. |
| Condensed Interim Consolidated Statements of Cash Flow |
| For the three and six months ended June 30, 2019 and 2018 |
| (in thousands of US dollars, except share and per share data) | ||||||||||||||||
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| (Unaudited) | 2019 | 2018 | 2019 | 2018 | ||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Cash flows from operating activities | ||||||||||||||||
| Net income (loss) for the period | 206 | (2,602 | ) | (4,705 | ) | 11,822 | ||||||||||
| Items not affecting cash and cash equivalents: | ||||||||||||||||
| Change in fair value of warrant liability (note 9) | (3,926 | ) | 134 | (1,865 | ) | (1,694 | ) | |||||||||
| Provision for restructuring costs (note 8) | 790 | - | 773 | (214 | ) | |||||||||||
| Depreciation and amortization | 70 | 21 | 136 | 35 | ||||||||||||
| Impairment of right of use asset (note 4) | 64 | - | 401 | - | ||||||||||||
| Write-off of current assets | - | - | 169 | - | ||||||||||||
| Deferred income taxes | - | - | - | 3,479 | ||||||||||||
| Share-based compensation costs | 595 | 392 | 690 | 515 | ||||||||||||
| Employee future benefits (note 10) | 2 | (311 | ) | 136 | (233 | ) | ||||||||||
| Amortization of deferred revenues | (18 | ) | - | (36 | ) | (541 | ) | |||||||||
| Foreign exchange loss on items denominated in foreign currencies | (4 | ) | (629 | ) | (49 | ) | (729 | ) | ||||||||
| Gain on disposal of property, plant and equipment | - | - | (3 | ) | 9 | |||||||||||
| Other non-cash items | - | 8 | - | 24 | ||||||||||||
| Changes in operating assets and liabilities (note 13) | 51 | (1,790 | ) | (823 | ) | (533 | ) | |||||||||
| Net cash (used in) provided by operating activities | (2,170 | ) | (4,777 | ) | (5,176 | ) | 11,940 | |||||||||
| Cash flows from financing activities | ||||||||||||||||
| Proceeds from issuance of common shares | 314 | - | 314 | - | ||||||||||||
| Payments on lease liability | (159 | ) | - | (310 | ) | - | ||||||||||
| Net cash from financing activities | 155 | - | 4 | - | ||||||||||||
| Cash flows from investing activities | ||||||||||||||||
| Disposal of property, plant and equipment | - | - | - | 11 | ||||||||||||
| Change in restricted cash | - | - | 50 | - | ||||||||||||
| Net cash from investing activities | - | - | 50 | 11 | ||||||||||||
| Effect of exchange rate changes on cash and cash equivalents | 341 | 175 | 293 | 215 | ||||||||||||
| Net change in cash and cash equivalents | (1,674 | ) | (4,602 | ) | (4,829 | ) | 12,166 | |||||||||
| Cash and cash equivalents - Beginning of period | 11,357 | 24,548 | 14,512 | 7,780 | ||||||||||||
| Cash and cash equivalents - End of period | 9,683 | 19,946 | 9,683 | 19,946 |
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 June 30, 2019 and for the three and six months ended June 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 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 June 30, 2019, the Company had an accumulated deficit of $316 million.
The Company also had a net loss of $4,705 for the six months ended June 30, 2019, and negative cash flow from operations of
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, 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. 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 Macrilen (macimorelin) outside of the United States
and Canada, or other monetization transactions relating to Macrilen (macimorelin).
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 $21 for the six months ended
June 30, 2019 and as at June 30, 2019, the Company had cash of $9,683.
Furthermore, nearly all of the Company's cash is held in AEZS Germany, our wholly owned German subsidiary.
AEZS Germany is also the counter-party for any and all cash received from revenue earned under the License and Assignment Agreement.
At the present time, the Company's North American operations are financed through the repayment of intercompany liabilities
by AEZS Germany to the Canadian parent company and its U.S. subsidiary. However, 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 such cash transfers to take place. Although the Company currently expects AEZS Germany to continue to transfer
cash to the Company's North American operations to finance operations in the Canadian parent company and its U.S. subsidiary,
in an amount sufficient for the Company (absent other funding sources) to finance most of its North American obligations, through
at least the remainder of 2019, there is significant risk that AEZS Germany's ability to make these transfers will become
restricted. The Company expects to have secured additional financing prior to the end of 2019 from third party sources; however,
there is no certainty that the Company will be successful in raising additional sources of cash.
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 obtain equity or debt financing in 2019 in order to fund its
ongoing operations. The outcome of these efforts is uncertain.
Management 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 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 June 30, 2019 and for the three and six months ended June 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") 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 ("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 Nordisk A/S ("Novo").
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.
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 August
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