IR Fact Sheet - May 2016 - Investor

INVESTOR FACT SHEET
Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) is a specialty biopharmaceutical company engaged in developing
and commercializing novel treatments in oncology, endocrinology and women’s health.
VALUE DRIVERS
Zoptrex™ (zoptarelin doxorubicin) – New Chemical Entity composed of a targeted synthetic peptide carrier linked to doxorubicin
 Potentially first FDA approved treatment in advanced endometrial cancer / $300M - $400M U.S. annual market opportunity
 Ongoing pivotal Phase 3 trial for treatment of advanced endometrial cancer under Special Protocol Assessment
 Final interim review by DSMB on efficacy and safety data successfully passed (October 2015)
 Pivotal trial completion expected Q3 2016; top-line results by year-end 2016
Macrilen™ (macimorilen) – Oral ghrelin receptor agonist / potential drug for evaluating Adult Growth Hormone Deficiency
 Potentially only FDA approved product in this indication; orphan drug status granted; $30M-$50M U.S. annual market opportunity
 Pivotal Phase 3 trial ongoing; trial completion expected Q3 2016; top-line results by year-end 2016
Apifiny® - The only cancer specific, non-PSA blood test that may aid clinicians in the assessment of risk for the presence of prostate
cancer.
 Large market opportunity / 20+ million PSA tests performed annually
 Apifiny® measures specific biological markers known to be associated with an immune system response to prostate cancer.
 Developed by Armune BioSciences in the U.S.
 Exclusive US-field promotion of Apifiny® by AEZS s on a commission basis, starting June 1, 2016
Saizen® – Recombinant human growth hormone (somatropin) for treatment of growth hormone deficiency in children and adults
 Large market opportunity / $1.6 billion US market with 10% annual growth
 Commercialized by EMD Serono in the U.S. / needle-free delivery system
 Co-promotion of Saizen® by AEZS salesforce in specific U.S. territories on a commission basis
EstroGel® – Non-patch transdermal estrogen (estradiol) therapy product
 ♯1 prescribed estrogen product in Europe / ♯1 prescribed transdermal estrogen product in Canada
 Commercialized in the U.S. by Ascend Therapeutics, subsidiary of Besins Healthcare International
 Co-promotion of EstroGel® by AEZS salesforce in specific U.S. territories on a commission basis
PIPELINE
(1)
Phase 2 in ovarian cancer completed.
and sponsored Phase 2 trial in castration and taxane resistant prostate cancer completed.
(3) Potential oral prostate cancer vaccine available for co-development/out-licensing, subject to an option granted to a third- party.
(4) Available for co-development/out-licensing.
(5) Compound library transferred to Medical University of South Carolina (MUSC), Aeterna Zentaris has access to future potential development
candidates.
(2) Investigator-driven
MILESTONES FOR 2016
Research & Development


Zoptrex™ (zoptarelin doxorubicin) – complete pivotal phase 3 program & report top-line results by year-end
Macrilen™ (macimorilen) – complete confirmatory phase 3 program & report top-line results by year-end
Business Development
 In-license commercial stage product(s) and commence AEZS selling in 2016
 Establish additional geographic collaborations for Zoptrex™ in non-U.S. territories
Commercialization – build commercial value through field selling of
 Apifiny®
 Saizen®
 EstroGel®
FINANCIAL DATA
Market data as at May 9, 2016
Closing price per share
Total common shares outstanding
Market capitalization
(in millions of US$)
Revenues
R&D costs
Net loss
Cash and cash equivalents
NASDAQ
$3.48
9.9 million
$34.6 million
As of and for the three months ended
March 31,
March 31,
2016
2015
0.2
0.1
3.7
4.5
(3.7)
(9.7)
33.0
53.3
STRATEGIC ALLIANCE OPPORTUNITIES
Aeterna Zentaris is actively seeks strategic alliances that will facilitate the building of a product portfolio of commercial stage products
in the U.S., while establishing partners in non-U.S. territories.
Please contact John Sharkey, Ph.D.
Business Development
[email protected]
FOR INFORMATION OR TO RECEIVE AN INVESTOR PACKAGE:
Please contact Philip A. Theodore
[email protected]
Aeterna Zentaris Inc.
315 Sigma Drive, Suite 302D
Charleston, SC 29486
www.aezsinc.com
NOTE & DISCLOSURES
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Forwardlooking statements may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “anticipates,”
and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties that could
cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the
availability of funds and resources to pursue R&D projects and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy
data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the rejection or nonacceptance of any new drug application by one or more regulatory authorities and, more generally, uncertainties related to the regulatory process, the ability of the
Company to efficiently commercialize one or more of its products or product candidates, the degree of market acceptance once our products are approved for
commercialization, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, the ability to protect our intellectual
property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company's quarterly
and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements.
Investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake to update these forward-looking
statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements
contained herein to reflect future results, events or developments, except if required to do so.
May 13, 2016