Third Quarter, 2015 Update

Transcription

1 Third Quarter, 2015 Update November 6, 2015

2 Forward Looking Statement This presentation contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 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 ability of the Company to efficiently commercialize one or more of its products or product candidates, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process, 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 U.S. 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, unless required to do so by a governmental authority or by applicable law. 2

3 Q3, Continued Progress ZoptEC Final Interim Review by DSMB Saizen Commercial Launch Series B Warrants 3

4 Capital Structure Update Series B Warrants virtually eliminated Share consolidation necessary Maintain NASDAQ listing Rebuild and move forward 4

5 Shareholder Value Growth Plan Successfully rebuild capital structure and investor confidence Achieve successful commercial presence and growth Field promotion & development of EstroGel, Saizen & additional in-licensed products Leverage sales force Focus on generating revenues and cash Pursue successful development and commercialization of our internal product portfolio Zoptrex in oncology Macrilen in endocrinology Become a profitable, growth oriented specialty biopharmaceutical company 5

6 ISS and Glass Lewis Recommend Shareholders of Aeterna Zentaris Vote FOR Share Consolidation Press Release For immediate release Leading Independent Advisory Firms ISS and Glass Lewis Recommend Shareholders of Aeterna Zentaris Vote FOR Share Consolidation Quebec City, Canada, October 27, Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) Stock consolidations, while not immediately adding to shareholder value, should enhance the longterm growth prospects of the company by broadening its financing alternatives. Continued low trading prices of the company's shares can put them below investment grade for many institutions, limiting the potential capital base for the company and its prospects for raising new capital as needed. 6

7 AEZS EstroGel Results Measure (Units) Q Q Q AEZS % over % 8% 8% AEZS % above baseline 8% 14% 15% 7

8 Saizen Market Overview Growth Hormones (GH) are used to treat Growth Hormone Deficiency (GHD) in both adult and pediatric patients Annually, approximately 40,000 pediatric patients are treated with GH $1.6 billion market that is growing 10% annually Six companies are actively promoting a GH brand No true generic competition in the market All products utilize the same molecule, somatropin Products are differentiated by mode of delivery, reimbursement, and patient support programs 8

9 AEZS Saizen Goals and Strategies 24 sales representatives promoting Saizen in specific US territories Increase market share and growth of Saizen by significantly increasing share-of-voice Generate profitable commission revenue: AEZS compensated for new patient starts, above an agreed-upon baseline 9

10 Aeterna Zentaris Commercial Strategy Achieve successful commercial presence and growth Field promotion & development of EstroGel, Saizen & additional in-licensed products Leverage sales force Focus on generating revenues and cash Pursue successful development and commercialization of our internal product portfolio Zoptrex in oncology Macrilen in endocrinology Become a profitable, growth oriented specialty biopharmaceutical company 10

11 Zoptrex (zoptarelin doxorubicin) A Potential Breakthrough in Cancer Therapy Product New Chemical Entity (NCE) composed of a targeted synthetic peptide carrier linked to doxorubicin Value proposition Improved, targeted delivery of therapy with improved benefit-risk profile 11

12 Zoptrex Phase 2 Success in Prostate Cancer Press Release For immediate release Aeterna Zentaris Zoptarelin Doxorubicin Meets Phase 2 Primary Endpoint in Men with Heavily Pretreated Castration and Taxane Resistant Prostate Cancer Quebec City, Canada, September 28, 2015 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the Company ) today announced that its lead oncology compound, zoptarelin doxorubicin (formerly AEZS 108), met the primary end-point of the investigator-driven and sponsored Phase 2 clinical trial in Castration and Taxane Resistant Prostate Cancer (CRPC) and demonstrated good tolerability. The primary endpoint was Clinical Benefit (CB) defined as remaining progression-free by RECIST and Prostate Specific Antigen (PSA) after treatment for 12+ weeks. Results were presented this morning by lead investigator, Jacek Pinski, MD, PhD, of the USC Norris Comprehensive Cancer Center, during a poster session at the 18th ECCO 40th ESMO European Cancer Congress in Vienna, Austria. 12

13 Zoptrex Multiple Potential Applications Tumor Site Endometrium 54,870 Locally advanced, recurrent or metastatic, failure after platinum-taxane Ovary 21,290 Estimated New US Cases 2015 Clinical Evaluation 9,000 Phase 3; ZoptEC trial; NCT (n=500), zoptarelin dox vs doxorubicin Platinum refractory or resistant 14,180 Phase 2; NCT (n=42) Prostate 220,800 Castration and taxane resistant 33,000 Phase 1/2; NCT (n=25) Breast 234,190 Chemotherapy refractory triple negative breast cancer 39,800 Phase 2; NCT Terminated (n=8) Bladder 74,000 Locally advanced unresectable or metastatic 16,000 Phase 1; NCT (n=13) Source: Cancer Facts & Figures 2015, ACS; literature estimates 13

14 Zoptrex Advances to Completion of Pivotal, Phase 3 Program Aeterna Zentaris: Data and Safety Monitoring Board Recommends Continuation of ZoptEC Phase 3 Trial in Advanced Endometrial Cancer DSMB's recommendation follows Final interim efficacy and safety analysis Press Release For immediate release Quebec City, Canada, October 13, 2015 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the Company ) today announced that the independent Data and Safety Monitoring Board ( DSMB ) has recommended that the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer, continue as planned. The DSMB's decision follows completion of its pre-specified second interim analysis on efficacy and safety for the ZoptEC Phase 3 trial at approximately 192 events. In April 2015, the DSMB made the same recommendation following its first pre-specified analysis on safety and futility at approximately 124 events. A final analysis of the data is expected at approximately 384 events. 14

15 Zoptrex Estimated US Annual Market Potential Treating Advanced, Recurrent Cancers Type of Cancer Endometrial Cancer Other Cancers (Ovarian; Prostate; etc.) Total Annual Market Potential $300 million $400 million > $500 million ~ $1 billion 15

16 Zoptrex Commercial Opportunity SUPERIOR EFFICACY Wide utilization within indication (5,000 9,000 pts/yr) Broadest utilization (15,000 30,000 pts/yr) EQUIVALENT EFFICACY Wide Utilization within indication (5,000 9,000 pts/yr) INFERIOR EFFICACY INFERIOR SAFETY EQUIVALENT SAFETY SUPERIOR SAFETY 16

17 Zoptrex Brand Development Core Scientific Explanation & Platform Strong relationships with Gynecological Oncology leaders Solidify product as new, targeted therapy 17

18 Macrilen (macimorelin) Product Novel orally-active ghrelin agonist that induces a fasting patient s GH secretion Status Confirmatory Phase 3 trial initiated; completion expected by year-end

19 Macrilen Strong Value Proposition Novel: potentially the only FDA approved product for evaluation of AGHD Accurate: comparable to current standard procedures Safe: well tolerated Convenient vs ITT If approved, anticipate rapid market penetration, acceptance and adoption 19

20 Erk Inhibitor Program Shows Progress and Promise Press Release For immediate release Aeterna Zentaris: Poster Presentation at AACR Meeting Provides Rationale for New Therapeutic Opportunities in Oncology with Erk Inhibitors Québec City, Canada, April 9, Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company") today announced that a poster on AEZS-134, a highly potent and selective ATP competitive Erk inhibitor, provides rationale for new therapeutic opportunities in oncology with this compound. The poster, titled, "Erk Inhibition as a Therapeutic Option for the Treatment of Raf- and Mek- Inhibitor Resistant Tumors", I. Seipelt, P. Schmidt, H. Märzhäuser, M. Gerlach, K. Jung, T. Schuster and M. Teifel, was presented yesterday by Irene Seipelt, Ph. D., Director, Preclinical Development at Aeterna Zentaris, during a poster session at the American Association for Cancer Research Annual Meeting in San Diego, California. 20

21 AEZS Erk Inhibitors & Competitors Key results compared to AEZS-134 improved equal decreased Erk2 inhibition IC 50 [nm] tumor cell in vitro inhibition GI 50 [ØnM] PK cmax Hct116 in vivo efficacy status of cpd AEZS-134 AEZS-140 AEZS-141 AEZS-139 GDC-0994 BVD-523 preclinical preclinical preclinical preclinical phase I phase I AEZS Erk inhibitor compounds showed higher tumor inhibition than the clinical-stage BVD-523 in the Hct116 model 21

22 Third Quarter Financial Highlights Aeterna Zentaris

23 Selected financial information Condensed interim consolidated statement of financial position information As of September 30, 2015 (amounts in thousands of US dollars except share data) Cash and cash equivalents $ 38,345 Shareholders' equity $ 12,824 Common shares outstanding 492,473,877 * Condensed interim consolidated statements of comprehensive loss and cash flows information (amounts in thousands of US dollars except per share data) Three months Nine months ended ended September 30, September 30, Loss from operations $ (7,501) $ (25,026) Net loss $ (15,290) $ (40,125) Net loss per share (basic and diluted) $ (0.07) $ (0.29) Net cash used in operating activities $ (7,150) $ (25,450) Net cash flows from financing activities $ - $ 28,737 * As of November 4, 2015, there were million common shares outstanding. 23

24 Operating expense snapshot (amounts in thousands of US dollars) 24

25 R&D cost snapshot (amounts in thousands of US dollars) 7,000 6,000 5,000 4,000 3,000 Comparative quarter-to-quarter 2,000 1,000 - Third-party costs Employee compensation and benefits Other costs Total research and development costs Three months ended 9/30/14 Three months ended 9/30/15 20,000 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 - Comparative nine month year-to-date Third-party costs Employee compensation and benefits Other costs Total research and development costs Nine months ended 9/30/14 Nine months ended 9/30/15 25

26 Third-party R&D cost snapshot (amounts in thousands of US dollars, except percentages) Three months ended 9/30/15 Zoptrex 1,985 Macrilen 408 Erk inhibitors 355 LHRH - Disorazol Z 50 Other 63 Total third-party costs 2,861 Three months ended 9/30/14 Zoptrex 2,122 Macrilen 68 Erk inhibitors 80 LHRH - Disorazol Z 47 Other 114 Total third-party costs 2,431 Nine months ended 9/30/15 Zoptrex 7,147 Macrilen 578 Erk inhibitors 1,010 LHRH - Disorazol Z 139 Other 118 Total third-party costs 8,992 Nine months ended 9/30/14 Zoptrex 6,059 Macrilen 212 Erk inhibitors 376 LHRH - Disorazol Z 202 Other 410 Total third-party costs 7,259 26

27 Condensed interim consolidated statements of comprehensive loss information (in thousands of US dollars, except share and per share data) 27

28 Condensed interim consolidated statements of cash flows information (in thousands of US dollars) 28

29 Aeterna Zentaris Q & A

30 Improving Life Transforming Value November 6, 2015