AEZS Aeterna Zentaris Inc

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS), a biopharmaceutical company engaged in developing and commercializing pharmaceutical products, today reported financial and operating results for the second quarter ended June 30, 2018.

All Amounts are in U.S. Dollars

Recent Key Developments

• The Company’s U.S. and Canadian out-licensing partner, Strongbridge Biopharma plc (NASDAQ: SBBP) officially launched our product Macrilen™ (macimorelin) in the United States effective July 23, 2018. Macrilen™ is the first and only FDA-approved oral ghrelin receptor agonist to be administered in the diagnosis of patients with adult growth hormone deficiency (AGHD) in the United States.
• The Company successfully submitted its required response to the European Medicines Agency (EMA) for the use of macimorelin for the evaluation of AGHD in July 2018.
• The Company continues to respond to out-licensing and other commercial partners for other markets globally.
• The Company’s financial condition remains strong with $19.9 million of cash and cash equivalents and no debt.

Commenting on recent key developments, Michael V. Ward, President and Chief Executive Officer for Aeterna Zentaris, stated, "We are very pleased with the continued progress being made by the Company in achieving our growth strategy of maximizing the global value of macimorelin. We are also very pleased with the launch of Macrilen™ in the United States."

Second Quarter Financial Highlights

• Cash $19.9 million 
• Revenues $0.2 million 
• Research and Development (“R&D") Costs $1.0 million 
• General and Administrative (“G&A") Expenses $2.0 million 
• Net loss $2.6 million

The Company will host a conference call to discuss these results on Friday, August 10, 2018, at 8:30 a.m., Eastern Time. Participants may access the conference call by telephone using the following dial-in numbers:

• Toll-Free: 877-407-8029, Confirmation #13681858
• Toll: 201-689-8029, Confirmation #13681858

A replay of the conference call will also be available on the Company’s website for a period of 30 days. For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the second quarter 2018, as well as the Company’s audited consolidated financial statements as at June 30, 2018, 2017, 2016 and 2015, can be found at www.zentaris.com in the "Investors" section.

About Aeterna Zentaris Inc.

Aeterna Zentaris Inc. is a biopharmaceutical company focused on developing and commercializing, principally through out-licensing arrangements, Macrilen™ (macimorelin), an oral ghrelin receptor agonist, to be administered in the diagnosis of patients with adult growth hormone deficiency.  Aeterna Zentaris has licensed Macrilen™ (macimorelin) to Strongbridge Biopharma plc in the United States and Canada. For more information, visit www.zentaris.com.

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 ("SEC"). 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 now heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully launch the product, 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 our product candidates, 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 products, the impact of securities class action litigation, the litigation involving two of our former officers, litigation brought by Cogas Consulting, LLC, or other litigation, on our cash flow, results of operations and financial position; any evaluation of potential strategic alternatives to maximize potential future growth and stakeholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, 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.

Contacts:

Aeterna Zentaris Inc. James Clavijo Chief Financial Officer IR@aezsinc.com 843-900-3201

 

Condensed Interim Consolidated Statements of Comprehensive Income (Loss) Information 

		Three months endedJune 30,						Six months endedJune 30,
(in thousands, except share and per share data)		2018			2017			2018			2017
		$			$			$			$
Revenues
Sales commission and other		79			131			169			284
Licensing revenue		89			112			24,657			220
Total revenues		168			243			24,826			504
Cost of goods sold		197			—			197			—
Research and development costs		974			3,599			1,807			6,054
General and administrative expenses		2,004			1,874			4,790			3,755
Selling expenses		497			1,449			2,138			2,991
Total operating expenses		3,475			6,922			8,735			12,800
(Loss) income from operations		(3,504	)		(6,679	)		15,894			(12,296	)
Gain due to changes in foreign currency exchange rates		677			196			725			261
Change in fair value of warrant liability		(134	)		3,914			1,694			5,317
Other finance income		126			19			144			37
Net finance income		669			4,129			2,563			5,615
(Loss) income before income taxes		(2,835	)		(2,550	)		18,457			(6,681	)
Income taxes		233			—			(6,635	)		—
Net (loss) income		(2,602	)		(2,550	)		11,822			(6,681	)
Other comprehensive income (loss):
Items that may be reclassified subsequently to profit or loss:
Foreign currency translation adjustments		(28	)		(659	)		(250	)		(792	)
Items that will not be reclassified to profit or loss:
Actuarial gain on defined benefit plans		205			194			205			635
Comprehensive (loss) income		(2,425	)		(3,015	)		11,777			(6,838	)
Net (loss) income per share (basic)		(0.16	)		(0.18	)		0.72			(0.49	)
Net (loss) income per share (diluted)		(0.16	)		(0.18	)		0.70			(0.49	)
Weighted average number of shares outstanding:
Basic		16,440,760			14,086,508			16,440,760			13,776,045
Diluted		16,440,760			14,086,508			16,489,364			13,776,045

 Condensed Interim Consolidated Statement of Financial Position Information

(in thousands, except share and per share data)		As at June 30,		As at December 31,
		2018		2017
		$		$
Cash and cash equivalents		19,946		7,780
Trade and other receivables and other current assets		1,367		958
Inventory		1,397		643
Restricted cash equivalents		373		381
Property, plant and equipment		75		101
Deferred tax assets		—		3,479
Other non-current assets		8,476		8,853
Total assets		31,634		22,195
Payables and other current liabilities		2,146		2,987
Current portion of deferred revenues		—		486
Warrant liability		2,203		3,897
Provision for restructuring costs		566		2,296
Taxes payable		2,904		—
Non-financial non-current liabilities		14,305		15,312
Total liabilities		22,124		24,978
Shareholders' equity (deficiency)		9,510		(2,783)
Total liabilities and shareholders' equity (deficiency)		31,634		22,195