SYNTHETIC BIOLOGICS (NYSE-MKT: SYN)

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1 UPDATE REPORT Biotechnology Industry June 26, 2013 SYNTHETIC BIOLOGICS (NYSE-MKT: SYN) Introducing a New Therapy for Multiple Sclerosis KEITH A. MARKEY, PH.D., M.B.A KMARKEY@GRIFFINSECURITIES.COM Investor Day presentations give a thorough review of Trimesta. Synthetic Biologics held a special meeting yesterday to introduce Trimesta to the investment community. The presentations covered the multiple sclerosis (MS) market, scientific basis of Trimesta, and the drug s clinical development. o A natural approach to disease modification. The scientific basis of Trimesta comes from observational analyses of pregnant women with MS that established a strong correlation between pregnancy and a decline in disease relapses. Dr. Rhonda Voskuhl, who is an expert in the field, has since conducted research showing that the pregnancyrelated hormone estriol reduces the number and severity of relapses. o A Phase 2 trial should provide clinical proof of concept. The multicenter study, which is sponsored by Dr. Voskuhl and supported by the Multiple Sclerosis Society, will be completed in January 2014 when the last of 164 patients receives the final dose. o Favorable data should lay the foundation for final clinical development. Synthetic Biologics will probably outlicense the drug for further development, given its focus on antibiotics, the cost of conducting the final clinical trials needed for FDA approval, the marketing muscle needed to compete in the $8.9 billion domestic MS market. Finances remain under tight control. The Company closed the March quarter with $8.5 million of cash, enough to fund operations through the first quarter of We are maintaining our BUY recommendation and price target of $4.00. Share Price (6/26/2013) $ Week Price Low / High $1.34-$2.55 Mkt. Capitalization (issued) $75.9 million Shares Outstanding (issued) million 12-month Target Price $4.00 Average Daily Volume (3 mos.) 63,486 Website syntheticbiologics.com Est d 2013 Earn s (Loss)/shr ($0.25) Est d 2014 Earn s (Loss)/shr ($0.21) Synthetic Biologics (NYSE-MKT: SYN) is a clinicalstage biotechnology company specializing in antiinfective agents for serious illnesses not addressed adequately by current drugs. A collaboration with Intrexon Corporation is developing antibody-based therapeutics for life-threatening Acinetobacter baumanii Source: BigCharts.com and Bortadella pertussis infections. Meanwhile, Synthetic Biologics has two programs in clinical development, a preventive medicine for severe diarrhea caused by Clostridium difficile and an oral therapy for multiple sclerosis. The corporate strategy is to become a leading specialist in biological anti-infective medicines. Griffin Securities, Inc., 17 State Street, New York, NY, Please Review Disclosures on Page 9 of this Research Report

2 A NATURAL APPROACH TO DISEASE MODIFICATION The relationship between pregnancy and a reduction in multiple sclerosis (MS) relapses was established in the seminal Pregnancy in Multiple Sclerosis Study conducted in Europe and published in the New England Journal of Medicine in The observational study followed 254 women who had MS through 269 pregnancies to assess the number of relapses suffered during each trimester. The results showed that as the pregnancy progressed, the number of relapses declined and that after delivery, the relapse rate surged before easing back to a pre-pregnancy level. (See Figure 1.) Figure 1. Rate of MS Relapse Before, During, and After Pregnancy 1 Dr. Rhonda Roskuhl and others investigated the phenomenon to identify the biological signals responsible for preventing the MS relapses. Preclinical research using an animal model of MS (experimental autoimmune encephalomyelitis or EAE) pointed to the involvement of sex hormones in the regulation of the immune system. Notably, estradiol was found to reduce EAE lesions, decrease inflammatory cytokines (e.g., tumor necrosis factor α and interferon γ), lower expression of an enzyme that facilitates T-cell migration into the central nervous system, and prevent activation of the NF-κB inflammatory pathway in astrocytes. 2,3,4,5 Studies with selective estrogen receptor modulators demonstrated further that the anti-inflammatory effects are mediated largely by one type of estrogen receptor (estrogen receptor α), while neuroprotection is provided by compounds that interact with either estrogen receptor α or β. 6 However, ligands to the estrogen receptor β also stimulate myelination (formation of support structures for neurons by glial cells that are lost gradually with MS). 7 Moreover, these compounds are synergistic with an anti-inflammatory agent, interferon β, on EAE disease severity. 8 The preclinical results provided the foundation for a small pilot study involving the estrogen-related hormone estriol that interacts more strongly with estrogen receptor β than α. In all, ten MS patients participated in a 22-month, cross-over trial that included four segments: (i) 6-month pretreatment, (ii) 6- month treatment, (iii) 6-month post-treatment, and (iv) 4-month retreatment. 9 The results, which are 1 Confavreux, C, et al. Rate of pregnancy-related relapse in multiple sclerosis. N Engl J Med 1998; 339(5): Bebo, BF, et al. Low-dose estrogen therapy ameliorates experimental autoimmune encephalomyelitis in two different inbred mouse strains. J Immunol 2001; 166(3): Matejuk, A, et al. 17 beta-estradiol inhibits cytokine, chemokine, and chemokine receptor mrna expression in the central nervous system of female mice with experimental autoimmune encephalomyelitis. J Neurosci Res 2001; 65(6): Gold, S, et al. Estrogen treatment decreases matrix metalloproteinase (MMP)-9 in autoimmune demyelinating disease throught estrogen receptor alpha (ER-α). Lab Invest 2009; 89: Giraud, SN, et al. Estradiol inhibits ongoing autoimmune neuroinflammation and NFkappaB-dependent CCL2 expression in reactive astrocytes. Proc Natl Acad Sci 2010; 107(18): Tiwari-Woodruff, S, et al. Differential neuroprotective and antiiflammatory effects of estrogen receptor (ER)α and ERβ ligand treatment. Proc Natl Acad Sci 2007; 104(37): Crawford, DK, et al. Oestrogen receptor β ligand: a novel treatment to enhance endogenous functional remyelination. Brain 2010; 133(10): Du, S, et al. Additive effects of combination treatment with anti-inflammatory and neuroprotective agents in experimental autoimmune encephalomyelitis. J Neuroimmunol 2010; 219(1-2): Sicotte, NL, et al. Treatment of multiple sclerosis with the pregnancy hormone estriol. Ann Neurol 2002; 52(4): 421. GRIFFIN SECURITIES EQUITIES RESEARCH 2

3 shown in Figure 2, provide strong support for treating MS patients with estriol. The six patients with relapsing remitting MS responded to treatment with a decline in the number and volume of brain lesions identified via magnetic resonance imaging. (Figure 2 shows total lesions, but similar results were found with new lesions as well.) Patients in a more advanced stage of the disease, secondary progressive MS, did not respond to the therapy, indicating that the earlier stage is more responsive to estriol. Figure 2. Total MS Lesion Volumes and Numbers by Stage of the Trial 9 TWO ONGOING CLINICAL STUDIES Two trials of Synthetic Biologics Trimesta are under way, one designed to provide clinical proof of concept for its use for relapsing-remitting MS and the other, to examine its effect on cognition in MS patients. In both studies, patients are also receiving glatiramer acetate (sold as Copaxone by Teva). PHASE 2 CLINICAL PROOF-OF-CONCEPT TRIAL The larger, relapsing-remitting MS study is fully enrolled with 164 patients participating at 15 medical centers in the United States. The basic information on the trial design is summarized in Table 1. Table 1. Combination Trial of Copaxone Plus Estriol in Relapsing-Remitting MS Number of subjects enrolled Study design Treatment arms Inclusion criteria Exclusion criteria Primary outcome measure Secondary outcome measures 164 relapsing remitting MS patients Randomized, double-blind, interventional (i) Estriol 8 mg capsule, once per day for 2 years with Copaxone injections (ii) Placebo pills and Copaxone injections Female, years old Diagnosis of relapsing-remitting MS with at least one relapse in the last two years Prior immune-altering therapy (e.g., lymphoid irradiation, T cell vaccination, methotrexate) A clinically significant disease other than MS Relapse rate Relapse severity Disease progress as measured by Expanded Disability Status Scale Cognitive function Paced Serial Addition Test and 7-24 Spatial Recall test MRI lesions and brain atrophy GRIFFIN SECURITIES EQUITIES RESEARCH 3

4 The results, which should be available in mid-2014, will likely set the stage for a licensing agreement with a multinational pharmaceutical company for the completion of the clinical development program and commercialization. Our financial model is based on an assumption that Synthetic Biologics receives a $10 million upfront payment and a royalty rate of 10%. PHASE 2/3 COGNITION STUDY The second trial that is under way is assessing the benefit of estriol for MS patients who exhibit cognitive impairment. The study s design is presented in Table 2. Table 2. Estriol Treatment of Women with MS: Effect on Cognition Number of subjects Study design Treatment arms Inclusion criteria Exclusion criteria Primary outcome measure Secondary outcome measures 64 relapsing remitting, secondary progressive, or primary progressive MS patients Randomized, double-blind, placebo-controlled (i) Estriol 2-2 mg capsules, twice per day with standard MS treatment and with progestin for 1 year (ii) Placebo pills and standard MS treatment Female, years old Diagnosis of relapsing-remitting, secondary-progressive, or primary-progressive MS Score of out of a possible 60 on cognition test No relapse within 30 days before enrollment Oral contraceptives or hormone replacement therapy use, pregnancy Prior immune-altering therapy (e.g., lymphoid irradiation, T cell vaccination, methotrexate) A clinically significant disease other than MS Drug abuse within the past 5 years Over- or under-weight (80% < ideal weight > 130%) MS disease duration greater than 15 years Change from baseline in cognitive function at 1 year as assessed by standardized addition test Change from baseline in cognitive function as assessed by electrophysiological measurement Change in standard MS outcome measures (e.g., relapses, 25-foot walk test, low contrast visual acuity) MRI lesions and brain atrophy The cognition study is expected to be completed in the spring of TRIMESTA ALIGNED WITH THE MAJOR TREND IN MS TREATMENT The overall trend in treatment of MS is toward more convenient, safer drugs, since patient compliance has been and remains a challenge. Many of the most commonly used medicines are injectable drugs that come with substantial side effects. The more recent entries are oral, but they too have toxicities that require considerable patient motivation for good compliance. Nonetheless, oral treatments are expected to gain acceptance through the remainder of this decade (see Figure 3) in a market growing 4.5% per annum. GRIFFIN SECURITIES EQUITIES RESEARCH 4

5 Figure 3. Projected Worldwide Oral MS Drug Sales Source: Synthetic Biologics Multiple Sclerosis-Estriol Presentation In contrast to today s most common therapies, Trimesta is an oral drug with fewer and milder side effects. Accordingly, we believe favorable clinical trial results will enable Trimesta to gain wide acceptance in the MS market. INVESTMENT CONSIDERATIONS Synthetic Biologics stock has traded off with the market weakness lately, which we believe renders the investment appeal that much more compelling. As outlined above, Trimesta has the potential to make a meaningful contribution clinically and sizable financial rewards to the Company. Synthetic s infectious disease program is at earlier stages of development, but it is on track to hit milestones over the next 18 months and to begin contributing to the operating performance in Overall, we rate SYN shares a BUY and maintain our 12-month price target of $4.00. FINANCIAL ANALYSIS We have not made significant changes to our estimates for Synthetic Biologics since our February report (see: following provides tables that have been updated for recent actual results. ANNUAL INCOME STATEMENTS # (FISCAL YEAR ENDS DECEMBER 31 ST ) # Data are in thousands, except per-share figures Total Revenues $ - $ - $ - $ 2,500 $ 2,500 $ 56,157 $ 115,033 Operating expenses G&A expense 2,588 5,012 4,500 4,900 6,000 8,000 9,203 R&D expense 3,340 3,287 7,200 8,000 10,000 14,000 13,804 Total operating costs 5,928 8,299 11,700 12,900 16,000 22,000 23,007 Operating profit/(loss) $ (5,928) $ (8,299) $ (11,700) $ (10,400) $ (13,500) $ 34,157 $ 92,027 Warrant-related (inc)/(exp) (1,734) Other Income/expense (net) Pretax profit/(loss) $ (7,626) $ (8,284) $ (11,650) $ (10,360) $ (13,400) $ 34,257 $ 92,152 Income taxes ,018 35,018 Net profit/(loss) - contin ops $ (7,626) $ (8,284) $ (11,650) $ (10,360) $ (13,400) $ 21,239 $ 57,134 Disc'd/nonrecur $ (523) $ (8,784) $ - $ - $ - $ - $ - Net profit/(loss) $ (8,149) $ (17,068) $ (11,650) $ (10,360) $ (13,400) $ 21,239 $ 57,134 Earnings/(loss) per share $ (0.28) $ (0.24) $ (0.25) $ (0.21) $ (0.28) $ 0.43 $ 1.15 Shares outstanding 27,710 34,897 46,363 48,413 48,700 49,200 49,700 GRIFFIN SECURITIES EQUITIES RESEARCH 5

6 QUARTERLY INCOME STATEMENTS # # Fiscal year ends December 31st. All figures are in thousands, except for per-share data. Estimates are in italics Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Total Revenues $ - $ - $ - $ - $ - $ - $ - $ - $ - $ - $ - $ - $ - $ - $ 2,500 $ - Operating expenses G&A expense $ 1,233 $ 524 $ 582 $ 249 $ 1,468 $ 1,176 $ 1,073 $ 1,295 $ 1,122 $ 1,125 $ 1,125 $ 1,128 $ 1,200 $ 1,200 $ 1,250 $ 1,250 R&D expense , ,591 1,118 1,700 2,100 2,282 2,000 2,100 2,000 1,900 Total operating costs 1, ,788 1,854 1,723 1,836 2,886 2,240 2,825 3,225 3,410 3,200 3,300 3,250 3,150 Operating profit/(loss) $ (1,464) $ (805) $ (871) $ (2,788) $ (1,854) $ (1,723) $ (1,836) $ (2,886) $ (2,240) $ (2,825) $ (3,225) $ (3,410) $ (3,200) $ (3,300) $ (750) $ (3,150) Warrant-related (inc)/(exp) (810) (760) (165) Other Income/expense (net) 51 (1) 6 (20) (2) Pretax profit/(loss) $ (2,223) $ (1,566) $ (1,030) $ (2,807) $ (1,849) $ (1,716) $ (1,826) $ (2,888) $ (2,228) $ (2,810) $ (3,212) $ (3,400) $ (3,193) $ (3,297) $ (740) $ (3,130) Income taxes Net profit/(loss) - contin ops $ (2,223) $ (1,566) $ (1,030) $ (2,807) $ (1,849) $ (1,716) $ (1,826) $ (2,888) $ (2,228) $ (2,810) $ (3,212) $ (3,400) $ (3,193) $ (3,297) $ (740) $ (3,130) Discontinued/nonrecurring $ 37 $ (114) $ (68) $ (378) $ 649 $ (156) $ (104) $ (9,173) $ - $ - $ - $ - $ - $ - $ - $ - Net profit/(loss) $ (2,186) $ (1,680) $ (1,098) $ (3,185) $ (1,200) $ (1,872) $ (1,930) $ (12,061) $ (2,228) $ (2,810) $ (3,212) $ (3,400) $ (3,193) $ (3,297) $ (740) $ (3,130) Earnings/(loss) per share $ (0.09) $ (0.06) $ (0.04) $ (0.09) $ (0.06) $ (0.05) $ (0.05) $ (0.07) $ (0.05) $ (0.06) $ (0.07) $ (0.07) $ (0.07) $ (0.07) $ (0.02) $ (0.06) Discontin'd/nonrecur per sh $ 0.00 $ (0.00) $ (0.00) $ (0.01) $ 0.02 $ (0.00) $ (0.00) $ (0.22) $ - $ - $ - $ - $ - $ - $ - $ - Shares outstanding 25,221 27,885 28,089 29,645 32,003 33,011 33,383 41,191 44,601 44,750 48,000 48,100 48,250 48,300 48,500 48,600 Note: We treated two one-time charges totaling $9 million for the Intrexon agreement and acquisition of the C. diff. program as non-recurring in Q4, GRIFFIN SECURITIES EQUITIES RESEARCH 6

7 BALANCE SHEET # (FISCAL YEAR ENDS DECEMBER 31 ST ) # Data are in thousands. ASSETS 3/31/ /31/2012 Current Assets Cash & equivalents $ 8,520 $ 9,954 Prepaid expenses & other 2,234 2,509 Note receivable Total Current Assets $ 11,454 $ 12,463 Long-Term Assets Property & equipment Other Total Assets $ 11,684 $ 13,423 LIABILITIES Current Liabilities Accounts payable $ 196 $ 395 Debt due - - Total Current Liabilities $ 196 $ 395 Long-term obligations - - Shareholders Equity Common Stock, par value $ 45 $ 44 Additional Paid-In Capital 82,612 81,925 Accumulated Deficit (71,169) (68,941) Total Shareholders Equity $ 11,488 $ 13,028 Total liabilities & equity $ 11,684 $ 13,423 GRIFFIN SECURITIES EQUITIES RESEARCH 7

8 INVESTMENT CONSIDERATIONS For a complete description of risks and uncertainties related to Synthetic Biologics business, see the Risk Factors section in Synthetic s SEC filings, which can be accessed directly from the SEC Edgar filings at Potential risks include: Stock risk and market risk: Trading of the Company s common stock varies widely on a daily basis. There can be no assurance that an active and liquid trading market will be sustained, which could limit one s ability to buy or sell the Company s common stock at a desired price. Investors should also consider technical risks common to many small-cap or micro-cap stock investments, such as float, risk of dilution, dependence upon key personnel, and the strength of competitors that may be larger and better capitalized. Competitive risk: The markets for multiple sclerosis drugs and anti-infective agents are highly competitive, based on individual product characteristics, pricing, and marketing support. Other companies are actively engaged in the development/commercialization of products to directly or indirectly address the uses being pursued by Synthetic Biologics. These companies may have substantially greater research and development capabilities, as well as significantly greater marketing, financial, and human resources than Synthetic. Products still in development phases: The Company s drugs may appear to be promising, but may not reach commercialization for various reasons, including a lack of efficacy in clinical trials, failure to achieve regulatory approvals, safety concerns, and/or the inability to be manufactured at a reasonable cost. And even if the products are commercialized, there can be no assurance that they will be accepted, which may prevent the Company from becoming profitable. Funding requirements: It is difficult to predict Synthetic s future capital requirements. The Company may need additional financing to continue to fund operations and expand its business. There is no guarantee that it can secure the desired future capital or, if sufficient capital is secured, that current shareholders will not suffer significant dilution. Regulatory risk: There is no guarantee that the Company s products under development will be approved by the Food and Drug Administration (FDA) or international regulatory bodies for marketing in the U.S. or abroad. In addition, regulations pertaining to drug development may undergo further changes, which may affect the Company s ability to gain regulatory approvals and/or labeling that supports its marketing strategies. Reimbursement risk: Healthcare reimbursement decisions have undergone significant changes and may continue to do so. There is no guarantee that the Company s drugs will receive adequate insurance coverage for them to be commercially viable. Patent risk: The field of pharmaceutical and biotechnology drugs is very competitive, and although Synthetic Biologics has licensed and/or filed for numerous patents to secure its right to commercialize its technology, these patents may not protect the Company s rights adequately in the marketplace. GRIFFIN SECURITIES EQUITIES RESEARCH 8

9 DISCLOSURES ANALYST(s) CERTIFICATION: The analyst(s) responsible for covering the securities in this report certify that the views expressed in this research report accurately reflect their personal views about Synthetic Biologics (the Company ) and its securities. The analyst(s) responsible for covering the securities in this report certify that no part of their compensation was, is, or will be directly or indirectly related to the specific recommendation or view contained in this research report. MEANINGS OF RATINGS: Our rating system is based upon 12 to 36 month price targets. BUY describes stocks that we expect to appreciate by more than 20%. HOLD/NEUTRAL describes stocks that we expect to change plus or minus 20%. SELL describes stocks that we expect to decline by more than 20%. SC describes stocks that Griffin Securities has Suspended Coverage of this Company and price target, if any, for this stock, because it does not currently have a sufficient basis for determining a rating or target and/or Griffin Securities is redirecting its research resources. The previous investment rating and price target, if any, are no longer in effect for this stock and should not be relied upon. NR describes stocks that are Not Rated, indicating that Griffin Securities does not cover or rate this Company. DISTRIBUTION OF RATINGS: Currently Griffin Securities has assigned BUY ratings on 79% of companies it covers, HOLD/NEUTRAL ratings on 21%, and SELL ratings on 0%. Griffin Securities has provided investment banking services for 16% of companies in which it has had BUY ratings in the past 12 months and 0% for companies in which it has had HOLD/NEUTRAL, NR, or no coverage in the past 12 months or has suspended coverage (SC) in the past 12 months. COMPENSATION OR SECURITIES OWNERSHIP: The analyst(s) responsible for covering the securities in this report receive compensation based upon, among other factors, the overall profitability of Griffin Securities, including profits derived from investment banking revenue. The analyst(s) that prepared the research report did not receive any compensation from the Company or any other companies mentioned in this report in connection with the preparation of this report. The analyst responsible for covering the securities in this report currently does not own common stock in the Company, but in the future may from time to time engage in transactions with respect to the Company or other companies mentioned in the report. Griffin Securities from time to time in the future may request expenses to be paid for copying, printing, mailing and distribution of the report by the Company and other companies mentioned in this report. The Company is currently a client of Griffin Securities, Inc. Griffin Securities' services for the Company consist of non-investment banking securities-related services and non-securities services. Griffin Securities has received compensation from the Company in the past 12 months for investment banking services and non-investment banking services. Griffin Securities expects to receive, or intends to seek, compensation for investment banking and non-investment banking services from the Company in the next three months. FORWARD-LOOKING STATEMENTS: This Report contains forward-looking statements, which involve risks and uncertainties. Actual results may differ significantly from such forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in the Risk Factors section in the SEC filings available in electronic format through SEC Edgar filings at on the Internet. DISCLOSURES FOR OTHER COMPANIES MENTIONED IN THIS REPORT: To obtain applicable current disclosures in electronic format for the subject companies in this report, please refer to SEC Edgar filings at In particular, for a description of risks and uncertainties related to subject companies businesses in this report, see the Risk Factors section in the SEC filings. GRIFFIN SECURITIES EQUITIES RESEARCH 9

10 PRICE CHART 2 Year BUY BUY Source: BigCharts.com Initiation report: 2/5/2013; share price, $1.82; rating, BUY; 12-month price target, $4.00; 6/26/2013 update: share price, $1.70; rating, BUY; 12-month price target, $4.00. GENERAL: Griffin Securities, Inc. ( Griffin Securities ) a FINRA (formerly known as the NASD) member firm with its principal office in New York, New York, USA is an investment banking firm providing corporate finance, merger and acquisitions, brokerage, and investment opportunities for institutional, corporate, and private clients. The analyst(s) are employed by Griffin Securities. Our research professionals provide important input into our investment banking and other business selection processes. Our salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies to our clients that reflect opinions that are contrary to the opinions expressed herein, and our proprietary trading and investing businesses may make investment decisions that are inconsistent with the recommendations expressed herein. Griffin Securities may from time to time perform corporate finance or other services for some companies described herein and may occasionally possess material, nonpublic information regarding such companies. This information is not used in preparation of the opinions and estimates herein. While the information contained in this report and the opinions contained herein are based on sources believed to be reliable, Griffin Securities has not independently verified the facts, assumptions and estimates contained in this report. Accordingly, no representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information and opinions contained in this report. The information contained herein is not a complete analysis of every material fact in respect to any company, industry or security. This material should not be construed as an offer to sell or the solicitation of an offer to buy any security in any jurisdiction where such an offer or solicitation would be illegal. We are not soliciting any action based on this material. It is for the general information of clients of Griffin Securities. It does not take into account the particular investment objectives, financial situations, or needs of individual clients. Before acting on any advice or recommendation in this material, clients should consider whether it is suitable for their particular circumstances and, if necessary, seek professional advice. Certain transactions - including those involving futures, options, and other derivatives as well as non-investment-grade securities - give rise to substantial risk and are not suitable for all investors. The material is based on information that we consider reliable, but we do not represent that it is accurate or complete, and it should not be relied on as such. The information contained in this report is subject to change without notice and Griffin Securities assumes no responsibility to update the report. In addition, regulatory, compliance, or other reasons may prevent us from providing updates. GRIFFIN SECURITIES EQUITIES RESEARCH 10

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