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COMPANY UPDATE
Buy
Jason Kolbert
(212) 895-3516
jkolbert@maximgrp.com
Diagnostic and therapeutic: AEZS-130. AEZS-130 (a ghrelin agonist) is being developed as a diagnostic test for adult growth hormone deficiency. The compound is also in a phase IIa study for cancerinduced cachexia, (first patient has been recruited). This trial is supported by a Cooperative Research and Development Agreement (CRADA) between AEZS and the Michael E. DeBakey Veterans Affairs Medical Center, which is funding the study. Valuation. We triangulate free cash flow (FCF), EPS, and sum of the parts. The critical assumption is the outcome of the interim analysis in the phase III multiple myeloma trial. We see the potential for perifosine to be >$500 million by 2017, which includes EU and Japan (royalty). Discounting this value back, averaged and equally weighted, suggests a $9.00 price target.
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SEE PAGES 7-9 FOR IMPORTANT DISCLOSURES AND DISCLAIMERS
AEZS-108 AEZS-108 AEZS-108 AEZS-108 AEZS-108 AEZS-108 AEZS-108 AEZS-108 AEZS-130 AEZS-130 AEZS-130 AEZS-130 AEZS-120 AEZS 137 AEZS 125 AEZS 129/136 AEZS 112
Phase III Start in Advanced recurrent Metastatic Endometrial Cancer: SPA N=500 patients, 80 sites, Global, Event Driven OS w/ Interim analysis 3 Years start to completions Approval Phase I/II POC Study Data ASCO in 2H -2013 (ASCO) Phase I/II : Castration & Taxance Resistant Prostate Cancer results Phase II in Breast Cancer - Initiation Phase II in Bladder (Investigator Driven) Small Study - data/results Oral Diagnostic Grehlin Agnonist- NDA Filing Priority Review Possible (6 Mos) Phase IIa Pilot Study (n=18-26) in cancer cachexia (muscle wasting) patients (enrollment/update) Top Line Data Presentation CTA Application to start P1 in Europe Highly Potent Doxorubicin , Next Generation 108 PreClinical Data Combination - PreClinical Data Sets conjugate Next Generation Perifosine IND Phase 1- Solid Tumors - New Formualtion
1Q-2013 2016 2017 2H-2013 2H-2013 1H-2013 2H-2013 1Q-2013 2014 2013 Q3-2013 4Q-2012 2013 2013 2014 2013
++ + +++ + + + + + ++ + + + + + + +
Stock Significance Scale: + of moderate importance; ++ higher level; +++ highly Source:Maxim Forecasts and Company reports.
VALUATION Our valuation metrics for Aeterna Zentaris assume that perifosine, AEZS-108 (doxorubicin conjugate), and AEZS-130 are all successfully developed. We project these revenues in our models. Each modelFCFF, EPS, and SOPare equally weighted in our calculations. We use a 30% discount rate, as we feel perifosine is a high-risk product in multiple myeloma, but we also include doxorubicin conjugate and AEZS-130 (diagnostic) with outyear potential as a therapeutic for muscle wasting as a side effect of cancer treatment. Combined, we believe these products represent a substantial global opportunity. Our model assumes dilution and uses a forecast share count for 2017. The average of these three metrics, equal weighted is $9.00 per share. Exhibit 2. FCFF Model We use a 30% discount rate and assume that perifosine, AEZS-108 (doxorubicin conjugate), and AEZS-130 are all successfully developed.
Price Target $ Year DCF Valuation Using FCF (mln): units (millions - $) EBIT Tax Rate EBIT(1-t) CapEx Depreciation Change in NWC FCF PV of FCF Discount Rate Long Term Growth Rate Terminal Cash Flow Terminal Value YE2017 NPV NPV-Debt Shares out (thousands) NPV Per Share
Source: Maxim estimates
7 2012
2012E (29,188) 0% (29,188) (152) 869 4,773 (33,244) (25,572) 30% 1% 821,177 221,167 248,490 668 36,759 7
2017E
Exhibit 3. Discounted EPS Model We use a 30% discount rate and a 10x peer multiple on 2017 projected EPS.
Current Year Year of EPS Earnings Multiple Discount Factor Selected Year EPS NPV
Source: Maxim estimates
$ $
8.5 0 5 10 15 20 25 30 35
Discount Rate and Earnings Multiple Varies, Year is 2016 EPS 5% 10% 15% 20% $0.00 $0.00 $0.00 $0.00 $9.97 $8.28 $6.93 $5.85 $19.95 $16.56 $13.86 $11.69 $29.92 $24.84 $20.80 $17.54 $39.90 $33.12 $27.73 $23.39 $49.87 $41.40 $34.66 $29.23 $59.85 $49.69 $41.59 $35.08 $69.82 $57.97 $48.52 $40.93
Constant 25% $0.00 $4.97 $9.93 $14.90 $19.86 $24.83 $29.80 $34.76 30% 4.24 8.49 12.73 16.98 21.22 25.47 29.71
$ $ $ $ $ $ $ $
LT Gr 1% 1% 1% 1% 1% 1%
Yrs. to Mkt 4 4 6 5 5 6
Term Val $1,034 $3.25 $1,034 $3.25 $517 $0.96 $1,724 $1.89 $1,379 $1.52 $690 $0.23 60% 37 $11
FUNDAMENTAL RISKS
Forecasting the Outcome of the Perifosine Pivotal Trial. We believe the principal risk in the stock today is the outcome of the event-driven interim analysis (around the phase III trial) with Perifosine. In addition, the company has pipeline risk associated with its other productsspecifically the doxorubicin conjugate, AEZS-108, and AEZS-130 (diagnostic and, later, a therapeutic). Partner Risk and Partnership Risk. The company is currently partnered with Yakult in Japan and does not control that companys decisions or timeline. In addition, the company may lack resources to develop its pipeline and may choose to see a partner. There are no assurances that the company will be successful to do so, or will be able to do so, on favorable terms. Competition. There are currently multiple products in development by other companies expected to compete with the pipeline and therapeutic indications that the company is pursuing. Regulatory. Predicting the decisions of the respective regulatory bodies is complex. The company will require regulatory approval from European, U.S., and Japanese regulators, as well as other geographies. Financing Risk. Aeterna Zentaris is like many micro-capitalized biotechnology companies. The company faces the challenge of raising capital to continue the development of its therapeutic pipeline.
Total Revenues % Chg Expenses COGS COGS % Sales R&D R&D % Rev's SG&A SG&A % Total expenses Oper. Inc. (Los s ) Oper Margin Inves tm ent Incom e Interes t Expens e FX Adjus tm ent Pre-tax income Pretax Margin Taxes (or benefits ) Tax Rate GAAP NI Net Margin GAAP-EPS Non GAAP EPS (dil) Wgtd Avg Shrs (Bas ) - '000s Wgtd Avg Shrs (Dil) - '000s
Source: Company reports and Maxim
9,510
7,471
7,139
7,200
31,320 -
32,297 3% 24,000 74% 24,000 74% 16,000 58,400 (26,103) NM (26,103) NM 0% (26,103) NM (0.77) (0.77) 32,762 32,762
36,502 13% 24,000 66% 28,000 77% 18,000 70,000 (33,498) NM (33,498) NM 0% (33,498) NM (0.88) (0.88) 37,901 37,901
51,456 41% 34,291 67% 32,000 62% 21,000 87,291 (35,835) NM (35,835) NM (1,792) 5% (34,043) NM (0.79) (0.79) 43,060 43,060
233,937 355% 70,787 30% 36,000 15% 23,000 129,787 104,150 45% 104,150 45% 15,623 15% 88,529 38% 2.05 2.05 43,157 43,157
543,579 132% 108,716 20% 41,000 8% 25,000 174,716 368,863 68% 368,864 68% 132,792 36% 236,074 43% 5.46 5.46 43,216 43,216
7,513 79% 5,572 3,213 16,298 (6,788) 77 (4,740) (255) (11,706) NM 0% (11,706) (0.66) (0.66) 17,669 17,669
6,262 84% 5,167 3,642 15,071 (7,600) NM 12,145 (5) 52 4,592 61% 0% 4,592 61% 0.25 0.25 18,510 18,510
5,556 78% 4,342 2,921 12,819 (5,680) NM 35 (909) (97) (6,651) NM 0% (6,651) NM (0.36) (0.36) 18,703 18,703
6,000 83% 5,000 69% 3,600 14,600 (7,400) NM (7,400) NM 0% (7,400) NM (0.23) (0.23) 27,685 32,000
25,331 81% 20,081 64% 13,376 58,788 (27,468) NM 12,257 (15,211) NM 0% (15,211) NM (1.00) (1.00) 20,642 20,642
DISCLOSURES
Source: Investars
Maxim Group expects to receive or intends to seek compensation for investment banking services from Aeterna Zentaris Inc. in the next 3 months. I, Jason Kolbert, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report. The research analyst(s) primarily responsible for the preparation of this research report have received compensation based upon various factors, including the firms total revenues, a portion of which is generated by investment banking activities. Valuation Methods: Our valuation metrics for Aeterna Zentaris assume that perifosine, AEZS-108 (doxorubicin conjugate), and AEZS-130 are all successfully developed. We project these revenues in our models. Each modelFCFF, EPS, and SOPare equally weighted in our calculations. We use a 30% discount rate, as we feel perifosine is a high-risk product in multiple myeloma, but we also include doxorubicin conjugate and AEZS-130 (diagnostic) with outyear potential as a therapeutic for muscle wasting as a side effect of cancer treatment. Combined, we believe these products represent a substantial global opportunity. Our model assumes dilution and uses a forecast share count for 2017. The average of these three metrics, equal weighted is $9.00 per share.
Price Target and Investment Risks: Aside from general market and other economic risks, risks particular to our price target and rating for Aeterna Zentaris Inc. include: 1) The interim analysis of the phase III perifosine trial; 2) The outcome of clinical development for the other pipeline products; 3) The ability of the company to raise capital; 4) Competitive products may limit market share penetration; and 5) Regulatory risk associated with EU, FDA, and Koseisho regulatory agencies in Europe, the United States, and Japan.
RISK RATINGS Risk ratings take into account both fundamental criteria and price volatility. Speculative Fundamental Criteria: This is a risk rating assigned to early-stage companies with minimal to no revenues, lack of earnings, balance sheet concerns, and/or a short operating history. Accordingly, fundamental risk is expected to be significantly above the industry. Price Volatility: Because of the inherent fundamental criteria of the companies falling within this risk category, the price volatility is expected to be significant with the possibility that the investment could eventually be worthless. Speculative stocks may not be suitable for a significant class of individual investors. High Fundamental Criteria: This is a risk rating assigned to companies having below-average revenue and earnings visibility, negative cash flow, and low market cap or public float. Accordingly, fundamental risk is expected to be above the industry. Price volatility: The price volatility of companies falling within this category is expected to be above the industry. High-risk stocks may not be suitable for a significant class of individual investors. Medium Fundamental Criteria: This is a risk rating assigned to companies that may have average revenue and earnings visibility, positive cash flow, and is fairly liquid. Accordingly, both price volatility and fundamental risk are expected to approximate the industry average. Low Fundamental Criteria: This is a risk rating assigned to companies that may have above-average revenue and earnings visibility, positive cash flow, and is fairly liquid. Accordingly, both price volatility and fundamental risk are expected to be below the industry.
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