UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2019
Commission File Number: 0-30752
Aeterna Zentaris Inc.
(Translation of registrant's name into English)
315 Sigma Drive, Suite 302D Summerville, South Carolina, USA 29486
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes ☐ No ☒
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-______.
On August 13, 2019, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
(c) Exhibit 99.1. Press release dated August 13, 2019
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Aeterna Zentaris Inc. | ||
(Registrant) | ||
Date: August 13, 2019 | /s/ MICHAEL V. WARD | |
Michael V. Ward | ||
CEO | ||
EXHIBIT 99.1
Aeterna Zentaris Reports Second Quarter 2019 Financial and Operating Results
CHARLESTON, S.C., Aug. 13, 2019 (GLOBE NEWSWIRE) -- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) today reported its financial and operating results for the second quarter ended June 30, 2019.
All Amounts are in U.S. Dollars
Highlights
Summary of Second Quarter Results and Year-to-date Second Quarter Results
For the three-month period ended June 30, 2019, we reported a consolidated net income of $0.2 million, or $0.01 income per common share (basic), as compared with a consolidated net loss of $2.6 million, or $0.16 loss per common share, for the three-month period ended June 30, 2018. The $2.8 million improvement in net results is primarily from a gain in fair value of warrant liability of $4.1 million, offset by a loss in exchange rates of $0.7 million, an increase in operating expenses of $0.3 million and $0.2 million movement in tax recovery.
For the six-month period ended June 30, 2019, we reported a consolidated net loss of $4.7 million, or $0.28 loss per common share, as compared with a consolidated net income of $11.8 million, or $0.72 income per common share (basic), for the six-month period ended June 30, 2018. The $16.5 million decline in net results is primarily from a reduction of $24.5 million in gross income and $0.6 million decrease in net finance income, offset by a reduction of tax expense of $6.6 million and operating expenses of $1.9 million.
Condensed Interim Consolidated Financial Statements and Management’s Discussion and Analysis
For reference, the condensed interim consolidated financial statements as at June 30, 2019 and for the three-month and six-month periods ending June 30, 2019 and 2018 and management’s discussion and analysis of financial condition and results of operations for the three-month and six-month periods ending June 30, 2019, will be found at www.zentaris.com in the "Investors" section and at the Company’s profile at www.sedar.com and www.sec.gov.
The tables below set out summary consolidated financial information for the periods indicated. These tables should be read together with the condensed interim consolidated financial statements as at June 30, 2019 and for the three-month and six-month periods ending June 30, 2019 and 2018 and management’s discussion and analysis of financial condition and results of operations for the three-month and six-month periods ending June 30, 2019, which contain important information relating to the Company. The results of operations for interim periods are not necessarily indicative of the results to be expected for a full year or any future period. The information presented herein does not contain disclosures required by IFRS for consolidated financial statements and should be read in conjunction with the Company’s audited annual consolidated financial statements for the year ended December 31, 2018.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a specialty biopharmaceutical company engaged in commercializing novel pharmaceutical therapies, principally through out-licensing arrangements. Aeterna Zentaris is the licensor and party to a license and assignment agreement with Novo Nordisk A/S to carry out development, manufacturing, registration, regulatory, and supply chain for the commercialization of Macrilen (macimorelin), which is to be used in the diagnosis of patients with adult growth hormone deficiency in the United States and Canada. In addition, we are actively pursuing business development opportunities for macimorelin in the rest of the world and to monetize the value of our non-strategic assets.
Forward-Looking Statements
This press release contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words "will," "expects," "believes," "intends," "would," "could," "may," "anticipates," and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in this press release and in our Annual Report on Form 20-F, under the caption "Key Information -Risk Factors" filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our ability to continue as a going concern dependent, in part, on the ability of Aeterna Zentaris to transfer cash from Aeterna Zentaris GmbH to the Canadian parent and U.S. subsidiary and secure additional financing, our now heavy dependence on the success of Macrilen (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, our strategic review process, the ability of the Special Committee to carry out its mandate, the ability of Aeterna Zentaris to enter into out-licensing, development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, reliance on third parties for the manufacturing and commercialization of Macrilen (macimorelin), potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, and, more generally, uncertainties related to the regulatory process, our ability to efficiently commercialize or out-license Macrilen (macimorelin), the degree of market acceptance of Macrilen (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our product, the impact of securities class action litigation or other litigation on our cash flow, results of operations and financial position, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.
Contact:
Leslie Auld
Chief Financial Officer
Aeterna Zentaris Inc.
IR@aezsinc.com
(843) 900-3211
Condensed Interim Consolidated Statements of Comprehensive Income (Loss)
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
(in thousands, except share and per share data) | 2019 | 2018 | 2019 | 2018 | ||||||||||||
$ | $ | $ | $ | |||||||||||||
Revenues | ||||||||||||||||
Royalty income | 8 | — | 21 | — | ||||||||||||
Product sales | 129 | — | 129 | — | ||||||||||||
Sales commission and other | 39 | 79 | 45 | 169 | ||||||||||||
Licensing revenue | 18 | 89 | 36 | 24,657 | ||||||||||||
Total revenues | 194 | 168 | 231 | 24,826 | ||||||||||||
Cost of goods sold | 101 | 197 | 101 | 197 | ||||||||||||
Gross income | 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 | 773 | — | 773 | — | ||||||||||||
Impairment of right of use asset | 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 | 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: | ||||||||||||||||
Basic | 16,622,415 | 16,440,760 | 16,532,090 | 16,440,760 | ||||||||||||
Diluted | 17,260,0168 | 16,440,760 | 16,532,090 | 16,489,364 |
Condensed Interim Consolidated Statement of Financial Position
(in thousands) | As at June 30, | As at December 31, | ||||
2019 | 2018 | |||||
$ | $ | |||||
Cash and cash equivalents | 9,683 | 14,512 | ||||
Trade and other receivables and other current assets | 1,524 | 1,504 | ||||
Inventory | 562 | 240 | ||||
Restricted cash equivalents | 367 | 418 | ||||
Property, plant and equipment | 48 | 65 | ||||
Right of use asset | 340 | — | ||||
Other non-current assets | 8,227 | 8,272 | ||||
Total assets | 20,751 | 25,011 | ||||
Payables and other current liabilities | 3,200 | 2,966 | ||||
Current portion of deferred revenues | 74 | 74 | ||||
Warrant liability | 1,451 | 3,634 | ||||
Current provision for restructuring costs and other costs | 1,004 | 887 | ||||
Taxes payable | 1,662 | 1,669 | ||||
Employee future benefits | 14,561 | 13,205 | ||||
Lease liabilities | 1,205 | — | ||||
Non-current portion of restructuring and other costs and deferred revenues | 622 | 669 | ||||
Total liabilities | 23,779 | 23,104 | ||||
Shareholders' (deficiency) equity | (3,028 | ) | 1,907 | |||
Total liabilities and shareholders' equity (deficiency) | 20,751 | 25,011 |