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Medgenics Investor Presentation 06/2012


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Investor presentation for Medgenics (AMEX:MDGN)

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Medgenics Investor Presentation 06/2012

  1. 1. Medgenics Presentation June 13, 2012 Andrew L. Pearlman, Ph.D. President & CEONYSE Amex: MDGNAIM: MEDU, MEDG
  2. 2. Forward-Looking Statements: This presentation includes certain estimates and other forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements with respect to anticipated operating and financial performance, clinical results, potential partnerships, licensing opportunities and other statements of expectation. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “assumes,” “seeks,” “estimates,” “should” and variations of these words and similar expressions, are intended to identify these forward-looking statements. While we believe these statements are accurate, forward-looking statements are inherently uncertain and we cannot assure you that these expectations will occur and our actual results may be significantly different. These statements by the Company and its management are based on estimates, projections, beliefs and assumptions of management and are not guarantees of future performance. Important factors that could cause actual results to differ from those in the forward-looking statements include the factors described in the Company’s filings with the U.S. Securities and Exchange Commission. The Company disclaims any obligation to update or revise any forward-looking statement based on the occurrence of future events, the receipt of new information, or otherwise. 2
  3. 3. Truly Personalized Medicine:  Innovative med-tech company developing sustained protein therapies for chronic diseases utilizing proprietary “Biopump” technology.  “Biopump” provides for continuous protein production and delivery from patient’s own skin.  Designed to be better, safer and cheaper, replacing scores of injections, in $130b protein market.  Potentially offering major advantages in treating a wide range of chronic diseases starting with anemia, hepatitis and hemophilia.  Proof of concept shown in patients: 6 months to 3 years sustained treatment.(1) RNCOS—Global Protein Therapeutic Market Analysis (Ed. 3, May 2010) 3
  4. 4. Experienced Management Team:Extensive experience in healthcare industry, founded, operated and led firms to M&Atotaling billions of dollars. Board of Directors: SAB/Advisors: Management:Andrew L. Pearlman PhD Clinical & Regulatory: Andrew L. Pearlman PhDPres/CEO >25yrs Biomed Allen Nissenson MD – past Pres. Founder President & CEO RPA, CMO DaVita Corp Clarence “Butch” DellioEugene Bauer MD, Exec Chm. Anatole Besarab MD – World Chief Operating OfficerFormer Dean, Stanford Med Sch, authority renal anaemia, Dir. RPA Xoma, NeosilConnetics, Peplin Stephen Fishbane MD – World Stephen Bellomo MScIsaac Blech-Biotech investor authority renal anaemia VP Product Development &Celgene, ICOS, Nova Bruce Bacon MD – Leading Hep C IP; COO Medgenics Israel authority- past Pres.AASLD Nir Shapir PhD 
Gary Brukardt, former CEO Nezam Afdhal MD – Leading Hep C VP R&D DevelopmentRenal Care Group (sold for $3.5B) authority – Chief of Hepatology, Beckman-Coulter Harvard Andra E. Miller PhD – Former FDA Ehud Shoshani MDAlastair Clemow PhD VP Clinical AffairsJ & J, Geliflex, Prolor cell/gene-therapy group leader Quintiles Israel Stephen Ettinger DVD – WorldJoel Kanter, founding investor renowned veterinary expert Phyllis Bellin MBA Dean Hautamaki MD – Chairman VP AdminI-Flow, Prospect Medical, Prolor Citibank Dept of Medicine , SMHStephen McMurray MD RPA,Fresenius, DaVita 4
  5. 5. Key Considerations: Proprietary Biopump, an autologous tissue-based platform technology for the sustained production and delivery of therapeutic proteins. 3 lead products address markets >$16B/yr in anemia, hepatitis and hemophilia.  EPODURE: Anemia/EPO - Completing Phase I/II in Israel, cleared for Phase IIa trial in dialysis patients in Israel commencing in Q2; IND cleared for Phase IIb in USA;  INFRADURE: Hepatitis/Interferon alpha – awaiting clearance of Phase I/II trials in Israel to treat hepatitis-C in Q2; filed for Orphan Drug Designation in hepatitis D; and  HEMODURE: Hemophilia/FVIII - being developed as a sustained Factor VIII therapy for the prophylactic treatment of hemophilia. Reimbursement: aiming at replacement value of current therapy Clinically demonstrated: one treatment can relieve anemia for 6-36 months. US FDA Clearance for Phase IIb Trial in dialysis patients with anemia IP protection: 30+ issued and 70+ pending patents. 5(1) R&D Pipeline News, La Merie Business Intelligence, March 3, 2011
  6. 6. Lead Products EPODURE (anemia) Sustained EPO therapy ($9.2B/yr market) could replace $15-30,000/yr/patient in injections, potentially offering:  Superior treatment at lower cost; 6-36+ months sustained EPO therapy - avoid peak overdose risks, improve compliance and reliability.  Improved hemoglobin control, directly address current key issues in anemia: • FDA hemoglobin safety, CMS reimbursement bundling INFRADURE (hepatitis) Sustained IFN-a therapy ($2.7B/yr mkt) could replace $35-85,000/yr/patient for current therapies, potentially offering:  Effective treatment with greatly increased compliance, reduced side effects – tolerable and safer, with unmatched treatment interval of 6+ months.  Cost effective alternative for most patients with hepatitis C, hepatitis B, and others, potentially replacing costly triple-treatments and new oral drugs.  Filed for Orphan Drug Designation in hepatitis D – potential expedited approval HEMODURE (hemophilia) Sustained FVIII therapy ($4.4B/yr mkt) could replace >$100-250,000/yr/patient injections, potentially offering:  Prophylactic treatment – rather than “rescue” injections.  > 6-12 months sustained FVIII therapy from single treatment. 6  Improved QOL at a lower cost.
  7. 7. Biopump Method:1. Harvest the tissue by needle biopsy from under patient’s skin.2. Process tissue into a drug producing Biopump in 10-14 days by controlled Biopump and a toothpick transfer of desired gene.3. Measure each Biopump’s continuous 10 Harvests protein production level. 4 Implants4. Implant required number of Biopumps under patient’s skin.5. Reversible by simple ablation, excision. 7
  8. 8. The Biopump Therapeutic Syst DermaVac Microorgan Biopump 8Cryo Bank
  9. 9. Repeat Bolus Injections vs. Biopump:Protein Injection overshoot – Adverse side effectsconcentration EPO: Cardiovascular Riskin serum IFN-a: Severe flu symptoms Therapeutic window .. .. Biopump Sustained Clinical Dose # of Days Injection undershoot Missed injection Injected dose in (No Effect) range 9
  10. 10. Biopump Platform: EPODURE in vitro: for anemia Sustained EPO high level production for 6+ months EPODURE long term in vitro EPO secretion 10000 Skin 1 Skin 2 1000IU / Biopump / day 100 10 1 6 9 16 25 36 46 66 80 101 122 143 164 185 T ime (Days) Ti Time to Implant in Patient 10
  11. 11. EPODURE Replaces Injections, Elevates Hemoglobin LevelUp to 36 Months of Continuous Anemia Relief: Estimated baseline 100 days after last injection EPO Injections EPODURE 11
  12. 12. Phase I/II Interim Study Conclusions: Presented at ASN 2010, 2011 by leading authorities.* EPODURE is safe and doseable; no antigenic response. EPO serum level always stayed within normal physiological range. Clinical feasibility demonstrated. Single EPODURE administration can raise and maintain hemoglobin (Hb) levels for up to 36 months without any injection of ESAs.  Elevated, maintained Hb 3+ mo in 13/17 patients, 6+ mo in 8/17 “We believe EPODURE may have significant potential to become an effective interventional treatment – a paradigm shift.” Allen Nissenson ,MD, CMO of DaVita Corp and past president of RPA Anatole Besarab, MD, Director of Clinical Research, Division of Nephrology and Hypertension, Henry Ford 12 Hospital - Detroit, MI
  13. 13. Biopump Platform: INFRADURE in vitro: for HepatitisSustained IFN-a high level production for 6+ months INFRADURE Long term in-vitro production 10000 1000IFN ng/Biopump/day 100 10 1 6 9 16 27 37 48 62 76 97 118 139 160 181 202 223 244 Days from harvesting Ti Time to Implant in Patient 13
  14. 14. One Platform → Multiple Alliances:Business model – Revenues before product approval.Platform: Same low-cost core technology – multiple deal opportunities.Major Opportunities: Each >$1B/year, no protein factory needed.Other Opportunities:  Niche applications – rapid route to product approval; high value- added.  New proteins/markets.Timing: Typical deals at Phase I/II or Phase II.Early Revenue Source:  Pre-approval milestone payments, typically $100M+.  Royalties on product sales, or transfer price. 14
  15. 15. Valuation metrics – Recent Comparables Licensing Deals Companies BMS + + Inhibitex AMEX: PBTH Ph III Hep C $11B Ph II Hep C $2.5B Cap $354m Phase II Nov 2011 Jan 2012 Feb 13, 2012 + SangamoBioSciences AMEX: PLX Discovery Hemophilia $213m Cap $546m Phase III Feb 2012 Feb 13, 2012*For comparison purposes only. Not a form of expressed or implied outcome* 15
  16. 16. Recent Achievements in 2012First Quarter Positive meeting with NIH RAC (Recombinant DNA Advisory Committee) for Phase IIb Trial in dialysis patients with AnemiaSecond Quarter Approval to initiate Phase IIa clinical study of EPODURE in patients on dialysis in Israel Filed for FDA Orphan Drug Designation for INFRADURE to treat hepatitis D US FDA Clearance to initiate Phase IIb Trial in dialysis patients with Anemia Launched US Biopump GMP processing center in California, produced EPODURE Biopumps meeting all release criteria 16
  17. 17. Anticipated Milestones thru 2012: Anemia:  Launch Phase IIa EPODURE Israel study in dialysis patients  Launch of Phase IIb EPODURE U.S study in dialysis patients Hepatitis C: Approval and launch of first INFRADURE clinical trials in Israel  Phase I/II in relapsed responding patients  Phase I/II in treatment naïve patients Obtain FDA Orphan Drug Designation for INFRADURE in hepatitis D Partnering: Pursue strategic alliances; active discussions continue with potential partners. 17
  18. 18. Route to Revenues: Regulatory:  FDA Clearance for Phase IIb EPODURE anemia trial (May 2012)  Filed for Orphan Drug INFRADURE for hepatitis D (April 2012 ), potential for expedited approval route using small pivotal trial.  QA designed in: automated processor using sealed cassettes. Clinical Pathway to Approvals:  Delivery of well-known proteins now in routine clinical use.  Better compliance – always on board.  Better safety: own protein, no peak overdose or under-dose between injections, ability to reverse or stop treatment Scale Up:  Reliable method >10,000 Biopumps made.  Closed system: Biopumps shipped to/from remote clinical sites to central GMP processing facilities  Planning upgrades, automated bioprocessor – early development. 18
  19. 19. Pipeline for Biopump Platform:Condition Protein Development stage 2010 Sales ($b)*Anemia Erythropoietin At Phase II 9.2Hepatitis Interferon Alpha Phase I/II (launching Q3) 2.7Hemophilia Factor VIII Preclinical 4.4Growth Retardation Growth hormone Future Candidate 3.0Multiple Sclerosis Interferon Beta Future Candidate 6.5Diabetes Insulin Future Candidate 15.5Arthritis IL-1Ra Future Candidate 20.9Wound Healing PDGF-BB Future Candidate NAObesity Peptide YY3-36 Future Candidate NAChronic Pain IL-10 Future Candidate NACancer Recovery G-CSF Future Candidate 5.4(1) R&D Pipeline News, La Merie Business Intelligence, March 3, 2011 19
  20. 20. Value Proposition: Game changer – Potential major win for: Patients Physicians Payors Pharma Partners Replaces frequent  Billable procedure  Reduces costs  Blockbuster opportunities Injections  Improved patient flow  Fewer claims  No multi-$B protein Improves quality of life manufacturing plant  Increased patient  Preventive Prevents side effects compliance & treatment  Superior value More reliable treatment reliability proposition to capture market share Safer, better outcomes Much more affordable 20
  21. 21. Key Take-Aways: Disruptive platform technology for >$130B protein market, multiple partnering opportunities, strong IP portfolio. Strong value proposition: Potentially better, safer, less costly. Lead products >$16B focusing on anemia (EPODURE) hepatitis (INFRADURE) and hemophilia (HEMODURE). Successfully demonstrated in patients: 6-36 months from a single treatment in patients, FDA Clearance for Phase II study Significant partnering potential; active discussions. Experienced, proven team. 2012 milestones: Launch Phase IIb anemia trial in U.S., Launch 3 trials in Israel (Ph IIa anemia, Ph I/II hepatitis C); Obtain Orphan designation for INFRADURE in hepatitis D. 21
  22. 22. Medgenics BioMed Presentation September 2011 Andrew L. Pearlman, Ph.D. President & CEONYSE Amex: MDGNAIM: MEDU, MEDG