Full Press Release Details
Condensed Interim Consolidated Financial Statements
Aeterna Zentaris Inc.
As at September 30, 2018 and for the three-month and nine-month periods ended September 30, 2018 and 2017
(presented in thousands of US dollars)
| Aeterna Zentaris Inc. |
| Condensed Interim Consolidated Financial Statements |
| (Unaudited) |
| As at September 30, 2018 and for the three-month and nine-month period ended September 30, 2018 and 2017 |
| 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) | 6 |
| Condensed Interim Consolidated Statements of Cash Flows | 8 |
| Notes to Condensed Interim Consolidated Financial Statements | 10 |
| Aeterna Zentaris Inc. |
| Condensed Interim Consolidated Statements of Financial Position |
| (in thousands of US dollars) |
| (Unaudited) | September 30, 2018 | December 31, 2017 | ||||
| $ | $ | |||||
| ASSETS | ||||||
| Current assets | ||||||
| Cash and cash equivalents | 16,800 | 7,780 | ||||
| Trade and other receivables (note 5) | 574 | 221 | ||||
| Inventory | 1,608 | 643 | ||||
| Prepaid expenses and other current assets | 571 | 737 | ||||
| Total current assets | 19,553 | 9,381 | ||||
| Restricted cash equivalents | 422 | 381 | ||||
| Property, plant and equipment | 71 | 101 | ||||
| Identifiable intangible assets | 86 | 90 | ||||
| Other non-current assets | - | 150 | ||||
| Deferred tax asset | - | 3,479 | ||||
| Goodwill | 8,330 | 8,613 | ||||
| Total assets | 28,462 | 22,195 | ||||
| LIABILITIES | ||||||
| Current liabilities | ||||||
| Payables and accrued liabilities (note 6) | 2,280 | 2,814 | ||||
| Current portion of provision for restructuring costs and onerous contracts (note 7) | 753 | 2,469 | ||||
| Income taxes payable | 2,339 | - | ||||
| Current portion of deferred revenues | - | 486 | ||||
| Total current liabilities | 5,372 | 5,769 | ||||
| Deferred revenues | - | 55 | ||||
| Warrant liability (note 8) | 2,145 | 3,897 | ||||
| Employee future benefits (note 9) | 13,040 | 14,229 | ||||
| Long-term portion of provision for restructuring costs and onerous contracts (note 7) | 495 | 1,028 | ||||
| Total liabilities | 21,052 | 24,978 | ||||
| SHAREHOLDERS' EQUITY (DEFICIENCY) | ||||||
| Share capital (note 10) | 222,335 | 222,335 | ||||
| Other capital | 89,288 | 88,772 | ||||
| Deficit | (304,237 | ) | (314,161 | ) | ||
| Accumulated other comprehensive income | 24 | 271 | ||||
| Total shareholders' equity (deficiency) | 7,410 | (2,783 | ) | |||
| Total liabilities and shareholders' equity (deficiency) | 28,462 | 22,195 |
Commitments and contingencies (note 17)
Subsequent events (note 18)
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
| Aeterna Zentaris Inc. |
| Condensed Interim Consolidated Statements of Financial Position |
| (in thousands of US dollars) |
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' Equity (Deficiency) |
| For the nine months ended September 30, 2018 and 2017 |
| (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, 2018 | 16,440,760 | 222,335 | 88,772 | (314,161 | ) | 271 | (2,783 | ) | |||||||||
| Net income | - | - | - | 9,313 | - | 9,313 | |||||||||||
| Other comprehensive income (loss): | |||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | (247 | ) | (247 | ) | |||||||||
| Actuarial gain on defined benefit plan (note 9) | - | - | - | 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 |
| (Unaudited) | Common shares (number of) 1 | Share capital | Other capital | Deficit | Accumulated other comprehensive income (loss) | Total | ||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||
| Balance - January 1, 2017 | 12,917,995 | 213,980 | 88,590 | (298,059 | ) | 1,701 | 6,212 | |||||||||||
| Net loss | - | - | - | (16,312 | ) | - | (16,312 | ) | ||||||||||
| Other comprehensive income (loss): | ||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | (1,192 | ) | (1,192 | ) | ||||||||||
| Actuarial gain on defined benefit plan (note 9) | - | - | - | 635 | - | 635 | ||||||||||||
| Comprehensive loss | - | - | - | (15,677 | ) | (1,192 | ) | (16,869 | ) | |||||||||
| Share issuances pursuant to the exercise of warrants (note 10) | 301,343 | 977 | - | - | - | 977 | ||||||||||||
| Share issuances in connection with "At-the-Market" drawdowns (note 10) | 3,221,422 | 7,378 | - | - | - | 7,378 | ||||||||||||
| Share-based compensation costs | - | - | 347 | - | - | 347 | ||||||||||||
| Balance - September 30, 2017 | 16,440,760 | 222,335 | 88,937 | (313,736 | ) | 509 | (1,955 | ) |
_____________________________
The 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 nine months ended September 30, 2018 and 2017 |
| (in thousands of US dollars, except share and per share data) |
| Three months ended September 30, | Nine months ended September 30, | ||||||||||
| (Unaudited) | 2018 | 2017 | 2018 | 2017 | |||||||
| $ | $ | $ | $ | ||||||||
| Revenues | |||||||||||
| Sales commission and other | - | 122 | 111 | 406 | |||||||
| Product sales (note 4) | 663 | - | 721 | - | |||||||
| Licensing revenue (note 4) | - | 119 | 24,657 | 339 | |||||||
| Total revenues | 663 | 241 | 25,489 | 745 | |||||||
| Cost of goods sold | 494 | - | 691 | - | |||||||
| Gross income | 169 | 241 | 24,798 | 745 | |||||||
| Operating expenses | |||||||||||
| Research and development costs | 358 | 4,124 | 2,165 | 10,178 | |||||||
| General and administrative expenses | 2,439 | 1,665 | 7,229 | 5,420 | |||||||
| Selling expenses | 383 | 1,652 | 2,521 | 4,643 | |||||||
| Total operating expenses | 3,180 | 7,441 | 11,915 | 20,241 | |||||||
| (Loss) income from operations | (3,011 | ) | (7,200 | ) | 12,883 | (19,496 | ) | ||||
| (Loss) gain due to changes in foreign currency exchange rates | (133 | ) | 169 | 592 | 430 | ||||||
| Change in fair value of warrant liability | 58 | (2,617 | ) | 1,752 | 2,700 | ||||||
| Other finance income | 30 | 17 | 174 | 54 | |||||||
| Net finance (loss) income | (45 | ) | (2,431 | ) | 2,518 | 3,184 | |||||
| (Loss) income before income taxes | (3,056 | ) | (9,631 | ) | 15,401 | (16,312 | ) | ||||
| Income tax recovery (expense) | 547 | - | (6,088 | ) | - | ||||||
| Net (loss) income | (2,509 | ) | (9,631 | ) | 9,313 | (16,312 | ) | ||||
| Other comprehensive (loss) income: | |||||||||||
| Items that may be reclassified subsequently to profit or loss: | |||||||||||
| Foreign currency translation adjustments | 3 | (400 | ) | (247 | ) | (1,192 | ) | ||||
| Items that will not be reclassified to profit or loss: | |||||||||||
| Actuarial gain on defined benefit plans | 406 | - | 611 | 635 | |||||||
| Comprehensive (loss) income | (2,100 | ) | (10,031 | ) | 9,677 | (16,869 | ) | ||||
| Net (loss) income per share [basic] | (0.15 | ) | (0.61 | ) | 0.57 | (1.13 | ) | ||||
| Net (loss) income per share [diluted] | (0.15 | ) | (0.61 | ) | 0.56 | (1.13 | ) | ||||
| Weighted average number of shares outstanding (note 16): | |||||||||||
| Basic | 16,440,760 | 15,803,080 | 16,440,760 | 14,457,421 | |||||||
| Diluted | 16,440,760 | 15,803,080 | 16,655,576 | 14,457,421 |
| Aeterna Zentaris Inc. |
| Condensed Interim Consolidated Statements of Comprehensive Income (Loss) |
| For the three and nine months ended September 30, 2018 and 2017 |
| (in thousands of US dollars, except share and per share data) |
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 and nine months ended September 30, 2018 and 2017 |
| (in thousands of US dollars) |
| Three months ended September 30, | Nine months ended September 30, | ||||||||||
| (Unaudited) | 2018 | 2017 | 2018 | 2017 | |||||||
| $ | $ | $ | $ | ||||||||
| Cash flows from operating activities | |||||||||||
| Net (loss) income for the period | (2,509 | ) | (9,631 | ) | 9,313 | (16,312 | ) | ||||
| Items not affecting cash and cash equivalents: | |||||||||||
| Change in fair value of warrant liability (note 8) | (57 | ) | 2,617 | (1,752 | ) | (2,700 | ) | ||||
| Provision for restructuring costs (note 7) | (120 | ) | 3,115 | (339 | ) | 3,115 | |||||
| Depreciation and amortization | 12 | (11 | ) | 47 | 55 | ||||||
| Deferred income taxes | - | - | 3,479 | - | |||||||
| Share-based compensation costs | 1 | (467 | ) | 516 | 347 | ||||||
| Employee future benefits (note 9) | 12 | 96 | (221 | ) | 270 | ||||||
| Amortization of deferred revenues | - | (119 | ) | (541 | ) | (339 | ) | ||||
| Foreign exchange loss (gain) on items denominated in foreign currencies | 140 | (182 | ) | (583 | ) | (464 | ) | ||||
| Loss (gain) on disposal of property, plant and equipment | - | (20 | ) | 9 | (20 | ) | |||||
| Other non-cash items | 2 | (14 | ) | 26 | (25 | ) | |||||
| Changes in operating assets and liabilities (note 12) | 84 | (918 | ) | (450 | ) | (2,313 | ) | ||||
| Net cash (used in) provided by operating activities | (2,435 | ) | (5,534 | ) | 9,504 | (18,386 | ) | ||||
| Cash flows from financing activities | |||||||||||
| Proceeds from issuances of common shares, net of cash transaction costs of nil in 2018 and $140 and $297 in 2017 (note 9) | - | 3,276 | - | 7,788 | |||||||
| Proceeds from warrants exercised | - | 242 | - | 242 | |||||||
| Net cash provided by financing activities | - | 3,518 | - | 8,030 | |||||||
| Cash flows from investing activities | |||||||||||
| Purchase of property, plant and equipment | - | - | - | (4 | ) | ||||||
| Proceeds from disposal of property, plant and equipment | - | 21 | 11 | 21 | |||||||
| Change in restricted cash equivalents | (50 | ) | 100 | (50 | ) | 150 | |||||
| Net cash provided by investing activities | (50 | ) | 121 | (39 | ) | 167 | |||||
| Effect of exchange rate changes on cash and cash equivalents | (661 | ) | 137 | (445 | ) | 363 | |||||
| Net change in cash and cash equivalents | (3,146 | ) | (1,758 | ) | 9,020 | (9,826 | ) | ||||
| Cash and cash equivalents - Beginning of period | 19,946 | 13,931 | 7,780 | 21,999 | |||||||
| Cash and cash equivalents - End of period | 16,800 | 12,173 | 16,800 | 12,173 |
| Aeterna Zentaris Inc. |
| Condensed Interim Consolidated Statements of Cash Flows |
| For the three and nine months ended September 30, 2018 and 2017 |
| (in thousands of US dollars) |
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 September 30, 2018 and for the three and nine months ended September 30, 2018 and 2017 |
| (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 engaged in developing and 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 and commercialization of Macrilen (macimorelin) in the United States and Canada (the "Strongbridge License Agreement").
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, 2017.
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 9, Financial Instruments ("IFRS 9"), and IFRS 15, Revenue from Contracts with Customers ("IFRS 15"), effective January 1, 2018. See note 3 for the impact of the adoption of IFRS 9 and IFRS 15.
The other standards did not have any significant impact on the Company's accounting policies and did not result in retrospective adjustments upon adoption.
These unaudited condensed interim consolidated financial statements were approved by the Company's Board of Directors on November 6, 2018
These unaudited condensed interim consolidated financial statements were prepared on a going concern basis.
2 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 3 to the Company's annual consolidated financial statements except for significant judgments under IFRS 15 relating to revenue recognition and under IFRS 11 relating to joint arrangements, as follows.
Accounting for the Strongbridge License Agreement
| Aeterna Zentaris Inc. |
| Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
| As at September 30, 2018 and for the three and nine months ended September 30, 2018 and 2017 |
| (tabular amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
IFRS 15 requires the Company to use a 5-step approach to evaluating, the timing and amount of revenue to be recognized with contracts with customers. In order to determine the amount and timing of recognition of revenue with respect to payments received from Strongbridge the Company had identified several distinct performance obligations it has under the Strongbridge License Agreement, which includes: (i) the sale of a "right to use" license of Macrilen (macimorelin) for diagnosing growth hormone deficiency in adults and any other future adult indication in the United States and Canada (the "Adult Indication"); (ii) the sale of a "right to use" license for a pediatric indication of Macrilen (macimorelin) in the United States and Canada which is contingent upon FDA approval (the "Pediatric Indication"); and (iii) interim supply arrangement provided by the Company for the sale of ingredients or finished product in the manufacturing of Macrilen (macimorelin) (the "Interim Supply Arrangement") (see note 4 - Licensing arrangement).
The research and development arrangement between the Company and Strongbridge for the development of the Pediatric Indication has not been separately identified as a performance obligation under IFRS 15. Under the terms of the agreement, Strongbridge will pay 70% of such development and the Company will pay the remaining 30%. If the Pediatric Indication is approved by the FDA, Strongbridge will be entitled to benefit from a right to use license for pediatric indication in the United States and Canada, and the Company will be entitled to the rights over this indication for the rest of the world. The Company has concluded that Strongbridge is a collaborator under this part of the arrangement and not a customer, and the arrangement should be accounted for under IFRS 11.
3 Summary of significant accounting policies
A) Impact of adoption significant new IFRS standards in 2018
The following new IFRS standards have been adopted by the Company from January 1, 2018
IFRS 9 Financial instruments
IFRS 9 Financial Instruments ("IFRS 9") replaces the provisions of IAS 39 Financial Instruments: Recognition and Measurement ("IAS 39") that relate to the recognition, classification and measurement of financial assets and financial liabilities, de-recognition of financial instruments, impairment of financial assets and hedge accounting.
The adoption of IFRS 9 on January 1, 2018 resulted in changes in accounting policies, however there were no adjustments to the amounts recognized in these interim consolidated financial statements. The Company has applied the changes in accounting policies retrospectively; however in accordance with the transitional provisions in IFRS 9, comparative figures have not been restated.
The Company's financial assets are mainly comprised of cash and cash equivalents, trade and other receivables, and restricted cash equivalents, which are classified and accounted for under IFRS 9 at amortized cost. Financial liabilities are mainly comprised of payables and accrued liabilities, which are accounted for at amortized cost, and warrant liabilities, which is a derivative that is accounted for at fair value through profit and loss (FVTPL).
The impairment of financial assets, including trade and other receivables, is now assessed using the simplified method of the expected credit loss model: previously, the incurred loss model was used. Applying the expected credit loss model has not had a significant impact on the value of the financial assets.
The Company applied the modified retrospective method upon adoption of IFRS 9 on January 1, 2018. This method requires the recognition of the cumulative effect of initially applying IFRS 9 to retained earnings and not to restate prior years. The application of this new standard has no impact on deficit.
IFRS 15 Revenue from contracts with customers
Effective January 1, 2018, the Company has adopted IFRS 15 Revenue from Contracts with Customers ("IFRS 15"). This new standard was applied using a modified retrospective approach. The adoption of IFRS 15 did not have a significant impact on the timing or measurement of the Company's revenue and no adjustment to the opening balance of deficit as at January 1, 2018 has been recorded as result of adopting IFRS 15.
| Aeterna Zentaris Inc. |
| Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
| As at September 30, 2018 and for the three and nine months ended September 30, 2018 and 2017 |
| (tabular amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
The impacts of adoption of the new standard are summarized below:
The Company's revenue consists of licensing fees representing non-refundable payments received at the time of executing the license agreement are recognized as revenue upon execution of the license agreements when the Company has no significant future performance obligation and collectability of the fees is probable. Under IFRS 15, the Company determines whether the Company's promise to grant a license provides its customer with either a right to access the Company's intellectual property ("IP") or a right to use the Company's IP. Revenue from a license that provides a customer the right to use the Company's IP is recognized at a point in time when the transfers to the licensee is completed and the license period begins. Revenue from a license that provides access to the Company's IP over a license term is considered to be a performance obligation satisfied over time and, therefore, revenue is recognized over the term of the license arrangement.
Revenue consists also of royalty income from the out-licensing of IP, which is recognized as earned and from manufacturing and other services, where revenue is recognized when control transfers to the third party and the Company's performance obligations are satisfied. The adoption of IFRS 15 did not significantly change the timing or amount of revenue recognized from these manufacturing and other services arrangements, nor did it change accounting for these royalty arrangements, as the standard's royalty exception is applied for IP licenses.
Furthermore, the Company receives milestone payments related to the out-licensing of IP. IFRS 15 did not significantly change the timing or amount of revenue recognized under these arrangements.
The Company applied the modified retrospective method upon adoption of IFRS 15 on January 1, 2018. This method requires the recognition of the cumulative effect of initially applying IFRS 15 to retained earnings and not to restate prior years. The application of this new standard effective January 1, 2018 had no impact on opening retained earnings.
The Company's updated accounting policies, effective January 1, 2018, upon adoption of IFRS 9 and IFRS 15 are as follows:
Financial instruments
Financial assets at FVTPL: Financial assets carried at FVTPL are initially recorded at fair value and transaction costs are expensed in the statement of income (loss). Realized and unrealized gains and losses arising from changes in the fair value of the financial assets held at FVTPL are included in the statement of income (loss) in the period in which they arise.
Financial liabilities at FVTPL: Warrant liabilities are classified as financial liabilities that are required to be measured at FVTPL. These financial liabilities are initially recognized at fair value, and transaction costs directly attributable to issuing the warrants are expensed in the statement of income (loss). Financial liabilities that are required to be measured at FVTPL have all fair value movements, excluding those related to changes in the credit risk of the liability which are recorded in other comprehensive income (loss), recognized in the statement of income (loss).
Financial assets at fair value through other comprehensive income (FVTOCI): Investments in equity instruments at FVTOCI are initially recognized at fair value plus transaction costs. Subsequently they are measured at fair value, with gains and losses arising from changes in fair value recognized in other comprehensive income (loss) in the period in which they arise.
Financial assets at amortized cost: A financial asset is measured at amortized cost if the objective of the business model is to hold the financial asset for the collection of contractual cash flows, and the asset's contractual cash flows are comprised solely of payments of principal and interest. They are classified as current assets or non-current assets based on their maturity date, and are initially recognized at fair value and subsequently carried at amortized cost less any impairment.
Impairment of financial assets at amortized cost: The Company recognizes a loss allowance for expected credit losses on financial assets that are measured at amortized cost.
| Aeterna Zentaris Inc. |
| Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
| As at September 30, 2018 and for the three and nine months ended September 30, 2018 and 2017 |
| (tabular amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
The following table shows the classification of the Company's financial assets/liabilities under IFRS 9:
Financial asset/liability IFRS 9 Classification
Cash and cash equivalents Amortized cost
Trade and other receivables Amortized cost
Warrant liability (derivative) FVTPL
Payable and accrued liabilities Amortized cost
License fees representing non-refundable payments received at the time of executing the license agreements. The Company's promise to grant a license provides its customer with either a right to access the Company's IP or a right to use the Company's IP. Revenue from a license that provides a customer the right to use the Company's IP is recognized at a point in time when the transfers to the licensee is completed and the license period begins. Revenue from a license that provides access to the Company's IP over a license term is considered to be a performance obligation satisfied over time and, therefore, revenue is recognized over time the term of the license arrangement.
Royalty and milestone revenue
Royalty income earned through a license is recognized when the underlying sales have occurred. Milestone income is recognized at the point in time when it is highly probable that the respective milestone event criteria are met, and the risk of reversal of revenue recognition is remote. Other revenue also includes revenue from activities such as manufacturing or other services rendered, to the extent such revenue is not recorded under net sales, and is recognized when control transfers to the third party and our performance obligations are satisfied.
B) Accounting standards adopted without impact
In December 2016, IFRIC 22, Foreign Currency Transactions and Advance Consideration ("IFRIC 22"), was issued. IFRIC 22 addresses how to determine the date of the transaction when applying IAS 21, The Effects of Changes in Foreign Exchange Rates, for the purpose of determining the exchange rate to use on initial recognition of the related asset, expense or income (or part of it) and on the derecognition of a non-monetary asset or non-monetary liability arising from the payment or receipt of advance consideration in a foreign currency. IFRIC 22 provides guidance for when a single payment/receipt is made, as well as for situations where multiple payments/receipts are made. The Company adopted this interpretation during the quarter ended March 31, 2018. The adoption of this interpretation did not have a significant impact on the Company's condensed interim consolidated financial statements.
C) Accounting standards not yet adopted
In January 2016, IFRS 16 Leases ("IFRS 16") was issued by the IASB. It replaces IAS 17 Leases for reporting periods beginning on or after January 1, 2019. It can be applied before that date by entities that also apply IFRS 15. IFRS 16 sets out a comprehensive model for the identification of lease arrangements and their treatment in the financial statements of both lessees and lessors. IFRS 16 applies a control model for the identification of leases, distinguishing between leases and service contracts on the basis of whether there is an identified asset controlled by the customer. The Company will adopt this standard in January 2019. The adoption of this standard is not expected to have significant impact on the Company's consolidated financial statements.
4 Licensing arrangement
Strongbridge License Agreement
| Aeterna Zentaris Inc. |
| Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
| As at September 30, 2018 and for the three and nine months ended September 30, 2018 and 2017 |
| (tabular amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
On January 16, 2018, the Company through Aeterna Zentaris GmbH entered into a license and assignment agreement with Strongbridge to carry out development, manufacturing, registration and 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 "right to use" license relating to the Pediatric Indication; and (iii) the Interim Supply Arrangement; and (iv) Strongbridge has agreed to fund 70% of the costs of a worldwide pediatric development program (the "PIP") to be run by the Company with customary oversight from a joint steering committee.
(i) Adult Indication
Under the terms of the license agreement, and for as long as Macrilen (macimorelin) is patent-protected, the Company will be entitled to a 15% royalty on annual net sales up to $75.0 million and an 18% royalty on annual net sales above $75.0 million. Following the end of patent protection in United States or Canada for Macrilen (macimorelin), the Company will be entitled to a 5% royalty on net sales in that country. In addition, the Company will also receive one-time payments ranging from $4.0 million to $100.0 million upon the achievement of commercial milestones going from $25.0 million annual net sales up to $500.0 million annual net sales.
In January 2018, the Company received an upfront cash payment of $24.0 million from Strongbridge which has been recognized as licensing revenue under IFRS 15.
On July 23, 2018, Strongbridge launched product sales of Macrilen (macimorelin) in the United States. To-date, the Company has not received royalty payments from Strongbridge.
(ii) Pediatric Indication
Upon approval by the FDA of a pediatric indication for Macrilen (macimorelin), the Company will receive a one-time milestone payment of $5.0 million.
During the third quarter of 2018, the Company invoiced Strongbridge $206 as its share of the costs incurred by the Company under the PIP and, to-date the Company had received $4. The amount is presented in the condensed interim consolidated statement of financial position as trade and other receivables. The Company considers the funding arrangement under the PIP to be a collaboration arrangement under IFRS 11 and has accounted for the invoicing as a reduction of costs incurred during the period.
(iii) Interim Supply Arrangement
The Company has agreed under the contract to supply ingredients for the manufacture of Macrilen (macimorelin) during an interim period at a price that is set at cost', without any profit margin. The Company believes the stand-alone selling price of the manufacturing ingredients to be their cost, as that approximates the amount at which Strongbridge would be able to procure those same goods with other suppliers.
During the third quarter of 2018, the Company invoiced and received from Strongbridge $663 under the Interim Supply Arrangement. These items are presented in the condensed interim consolidated statements of comprehensive income (loss) as product sales and cost of goods sold.
5 Trade and other receivables
| Aeterna Zentaris Inc. |
| Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
| As at September 30, 2018 and for the three and nine months ended September 30, 2018 and 2017 |
| (tabular amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
| September 30, | December 31, | ||||
| 2018 | 2017 | ||||
| $ | $ | ||||
| Trade accounts receivable | 300 | 20 | |||
| Value added tax | 262 | 186 | |||
| Other | 12 | 15 | |||
| 574 | 221 |
6 Payables and accrued liabilities