PetVivo Holdings, Inc (PETV) Company Presentation
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PetVivo Holdings, Inc. (PETV) corporate presentation covering the Kush(tm) canine and equine joint injection osteoarthritis treatment and how it stacks up against competitors. Also covered are Kush(tm) treatment market estimates, the PETV product pipeline and IP portfolio. The appendixes cover additional products and the technology and manufacturing processes and potential, human therapeutics products and market estimates including SynovoLife, CosmetaLife, DiscLife, UroLife and the VasoShunt cardiovascular products.
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PetVivo Holdings, Inc (PETV) Company Presentation
- 2. !!FORWARDELOOKING!STATEMENTS! Statements!in!this!presentaNon!that!are!not!historical!facts!are! “forwardElooking!statements”.!Viewers!are!cauNoned!that!any! such!statements!are!not!guarantees!of!future!performance!and! that!actual!developments!or!results!may!vary!materially!from! those! in! these! “forwardElooking! statements”.! Statements! regarding! future! plans! and! objecNves! are! forwardElooking! statements!that!involve!various!risks!and!uncertainNes.!Much! of! the! informaNon,! analysis,! plans! and! conclusions! contained! herein! were! assembled! or! derived! by! company! management! and!there!can!be!no!assurance!that!they!will!prove!accurate.! No! securiNes! regulator! or! stock! exchange! has! reviewed! or! accepted! responsibility! for! the! adequacy! or! accuracy! of! this! presentaNon.!
- 3. PetVivo!Holdings!(PETV)! GelEDel!! PetVivo! • Royalty!Free!Mayo!Clinic!Technology!Transfer! • IniNal!Focus!–!Vet!Devices!Developed!for!Humans! • No!FDA!Approval!Required!for!Vet!Devices!! • Kush!Canine!ProducNon!&!Revenues!Q1!‘16!! • Cash!Flow!PosiNve!Within!12!Months!PostElaunch! • Validated!&!Scalable!Manufacturing! • Successful!Pivotal!FDA!Human!Trial!! • $13M+!Invested!Including!$7M!From!NIH! • Strong!IP!&!Extensive!Product!Pipeline!
- 4. !Our!Pet/Vet!Market! U.S.!Pet!Owners!Spend*!! Source:!APPA;!USD!in!Billions! *!Agricultural!and!professional!equine!markets!not!included! !! • Large!and!Growing!Market! o 2015E!U.S.!Pet!Spend!$60B! • InsensiNve!to!Recent!Recession!! • 68%!of!U.S.!Households!!!! o 96M!Cats! o 83M!Dogs! o 8.3M!Horses! • Vet!Care!a!Leading!Growth!Driver! o $15B!in!U.S.!(2014)! o 26%!of!Pet!Spend! o FiveEyear!CAGR!of!6.4%! • Pet!TherapeuNcs!Account!for!Just! 3%!of!All!Pet!Expenditures!! • Market!Ripe!for!Bener!and!More! EffecNve!TherapeuNcs! $59!! $56! $53! $51! $48! $46! $43! $41! $39! $36! $34! $32! $30!$29! $23! $21! $17! $0!! $10!! $20!! $30!! $40!! $50!! $60!!
- 5. Problem:!Canine!&!Equine!! Lameness!From!OsteoarthriNs!(OA)! • No!current!treatment!for!OA,!only!palliaNve!pain!therapy! or!joint!replacement! • OA!is!a!condiNon!with!degeneraNng!carNlage,!creaNng! joint!sNffness!from!mechanical!stress!resulNng!in! inflammaNon!&!pain! • OA!lameness!worsens!with!Nme!from!ongoing!loss!of! protecNve!cushion!and!lubricity!(i.e.,!loss!of!slippery! padding)! • NSAIDS!are!used!to!alleviate!the!pain!and!inflammaNon,! but!longEterm!cause!gastric!problems! • NSAIDS&do¬&treat&the&car0lage°enera0on&issue&to& halt&or&slow&the&progression&of&the&OA&condi0on&&
- 6. Our!SoluNon:!Kush™!Joint!InjecNon! for!the!Treatment!of!OsteoarthriNs! • Superior!treatment!to!safely!improve!joint!funcNon! • ReparaNve!Kush!parNcles!are!lubricious,!cushioning!&!longElasNng! • These!spongy!proteinEbased!parNcles!mimic!the!composiNon!and! protecNve!funcNon!of!carNlage!(i.e.,!providing!both!a!slippery!cushion! and!healing!scaffolding)! • Kush!parNcles!protect!the!joint!as!an!arNficial!carNlage! Pain& Inflamma0on& Kush&Treated&Joint& Kush&Par0cles&Cushioning&and& Protec0ng&Joint& 4&layers&of& car0lage& Painful&Inflamed&Joint&
- 7. !!!!Kush!Canine!OA!Treatment! • Kush!Canine!ParNcles!Injected!! Into!Synovial!Space!! • Standard!IntraEArNcular!Technique!! • No!Special!Training! • MulNple!Joints!Can!Be!Treated! Simultaneously! • No!Recovery!Period! • Case!Studies!Show!That!Kush! Canine!Increases!WalkingERunning! AcNvity!&!Eliminates!Pain! MedicaNons!(e.g.,!NSAIDS)!
- 8. !!!Kush!Equine!Lameness!Treatment! • No!Current!ReparaNve!Treatment!for! Equine!Joint!Lameness! • Kush!Equine!Injected!Into!Synovial! Joint!Space!Using!Standard! Technique! • No!Special!Training!Required! • MulNple!Joints!Can!Be!Treated! • No!Special!PostETreatment!! • Case!Studies!Demonstrate!the!! Reduced!Appearance!of!Lameness! Beyond!Six!Months!
- 9. Kush!!vs.!CompeNNon! Treatment( Rimadyl((NSAID) Hyaluronic(Acid((((((((((((((((((((((((((((( Joint(Injections Total(Joint(Replacement( Kush™(Canine(0(PetVivo Pro Temporary(Pain(Relief Temporary(Pain(Relief((((((((((((((((( Good(Safety(Profile (Joint(Replaced Protects(Joint(0(Increases( Activity(0(Reduces(Pain(0( Excellent(Safety(Profile Con Potential(for(Gastric(Ulcers( and(Kidney(Problems(Does( Not(Treat(Condition( Effectiveness(Diminishes( Over(30(Days(J( Minimally(Invasive((((( Invasive(and(Expensive( Surgical(Procedure( Requiring(Rehabilitation Minimally(Invasive((( Typical((((( Owner(Cost* $0.90(J($2.40(per(day((((((( Blood(Testing(Required((to( Monitor(Toxicity $150(J($250(per(joint $2,000(J($4,000(((((((((((((((( per(joint $400(0($600(per(joint( Annual((((((( Owner(Cost( $400(J($700 $1,800(J($3000 $2,000(J($4,000 $400(0($600( Treatment( Once(or(Twice(Daily((((((((((((((( by(Owner Monthly(((((((((((((((((((((((((((( at(Vet((Clinic( Surgery(and(Rehab Typically(Once(per(Year((((((((((((( at(Vet(Clinic Vet(Revenue( Opportunity Vet(Revenue(Declining( Animal(Scripts(Can(Now(be( Filled(at(Most(Pharmacies (Short(Duration(of( Effectiveness(Limits( Repeat(Business Good(OneJTime(Revenue( Surgical(Expertise(Required((((( Price(Resistance( Repeat/Referral(Business( Due(to(Kush's(Effectiveness/( Duration/Value(Multiple( Joints(Can(Be(Treated *Costs(may(very(depending(on(animal(size,(dosing(and(treatment(location
- 10. IniNal!Kush!Markets!&!Comps! • Kush!Canine:!OsteoarthriNs!Market!EsNmate!!! • 20,000,000!dogs!with!OsteoarthriNs!(USEEU)! • $2.6B&USIEU&Market&& • Kush!Equine:!Lameness!Market!EsNmate! • 1,000,000!lame!horses!(USEEU)! • $600M&USIEU&Market& • Our!comp!group!consists!of!companion!animal! diagnosNc/pharm!companies!Abaxis,!Aratana! TherapeuNcs,!IDEXX!and!ZoeNs.!Abaxis,!IDEXX!and! ZoeNs!currently!trade!at!4.0x!to!5.0x!2014!sales.!!
- 11. Pet!Business!Model:!PetVivo,!Inc.! • US!DistribuNon!! o Sales!through!exisNng!veterinary!distributors!! • MWI,!Panerson!Veterinary,!Butler!Schein!Animal!Health!! o Regional!Business!Development!&!Training!Reps! • Educate!veterinarians!&!clinic!Staff! • Provide!distributor!rep!training! • Technical!support! o MarkeNng!&!Training! • Demand!side!pull!strategy!E!costEeffecNve!social!media!! • Online!Media!E!consumer!educaNon!&!veterinary!professional! training! • Canadian!DistribuNon!! o Establish!Canadian!distribuNon!&!technical!support!&!training! • European!DistribuNon! o Establish!regional!EU!distribuNon!channels! !
- 12. !! !Pet&Therapeu0cs&& Species! Safety! Pilot!! Efficacy! Commercial!! VDE01! &Osteoarthri0s& !Canine!(Kush)! !! !! !! !! Q1&2016&& VDE02!!&Osteoarthri0s& !Equine!(Kush)! !! !! !! !! Q3&2016& VDE03!!&Digital&Cushion&Lameness& !Equine!&!Bovine! !! !! !! 2016& VDE04! &Urinary&Incon0nence&& !Canine! !! !! !! !! 2017& VDE06! &Osteoarthri0s& !Feline!(Kush)! !! !! !! !! 2017& Pet!&!Human!Product!Pipeline! Par0cle&Based&Devices&& Molded&Vascular&Devices&& Drug&Delivery&Devices& !! !Human&Therapeu0cs& Biomaterial! Safety! Proof!of! Concept! Preclinical! Studies! Pivotal! !Trial!! FDA! Submission! Launch! HDE05! &Dermal&Filler& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2017& HDE07! &Osteoarthri0s& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2017& HDE08! &Dermal&Filler&I&Lip& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2018& HDE09! &Spinal&Disc&Repair& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2018& HDE10! &Arteriovenous&(AV)&Shunt&& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2018& HDE11! &Limb&Salvage&Shunt& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2018& HDE12! &Female&Urinary&Incon0nence& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019& HDE13! &Peripheral&Vascular&Gra^&& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019& HDE14! &Coronary&Artery&Bypass&Gra^& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019& HDE15! &Drug&Elu0ng&Stent&Coa0ng& !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019& HDE16! &Mucoadhesive&Fentanyl&& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019& HDE17! &Vasculitus&Wound&Closure& !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! 2019&
- 14. VerNcally!Integrated!IP!Porvolio! Raw!Materials!to!Finished!Products! • Eight!US!Patents!with!328!Claims! • Broad!Claim!Language!E!“Comprising”!TransiNons! • Our!Patents!&!Trade!Secrets!Protect:! • Protein!&!Carbohydrate!Based!ThermoplasNcs! • Biomaterials!of!Many!ComposiNons!! • Medical,!Drug!Delivery!&!CombinaNon!Products! • Medical!&!PharmaceuNcal!ApplicaNons! • Validated!SelfEAssembly!ProducNon!Processes! • Our!Intellectual!Property!is!Extensively!Cited!! • Over!150!Patent!Examiners!CitaNons!! • Over!250!Patent!Applicant!CitaNons!
- 17. Proven!Products!E!Validated!Mfg.!! Pet!Market!Launch!Ready! • Demonstrated!Human!Safety!&!Efficacy! o Classified!as!a!Medical!Device!by!the!FDA!! o Pivotal!FDA!Human!Trial!Successfully!Completed!! o Ten!Years!of!Safety!&!Efficacy!in!Many!Species! • Validated!Manufacturing!! o Manufacturing!FDA!Validated!For!Human!Trial!! o SingleEUse!Inline!MFG!Processes! o Very!Scalable!Manufacturing!! o Low!CAPEX!Infrastructure!! o Room!Temp!Stable!Beyond!24!Months! • Commercial!Ready!in!Pet/Vet!Market! o ParNcles!Defined!as!a!Medical!Device!! o No!FDA!Clearance!Required!for!Vet!Devices! o Significant!Margins!! ! ! ! CloseEup!of! syringe!needle! point! ParNcles!
- 18. PetVivo!Investment!Highlights! • IniNal!Kush!product!producNon!&!revenues!Q1!2016! • Cash!flow!posiNve!within!12!months!of!commercial!launch! • Risk!much!lower!by!iniNally!focusing!on!veterinary!devices! that!are!in!lateEstage!development! • Business!and!manufacturing!processes!easily!scalable!!!!! • Products!proven!in!both!pets!&!humans! • Extensive!pet!and!human!product!pipeline! • InEclinic!treatments!grow!vet!pracNce!revenues!and! accelerate!product!adopNon! • Experienced!management!! • Strong!intellectual!property!porvolio!
- 23. CostEEfficient!Scalable!Manufacturing • Manufacturing!Process!FDA!Validated! for!Human!Clinical!Trial!ProducNon! • Manufacturing!Scaled!from!0.01! Kilograms!to!Several!Kilograms!in! Practice!E!Thousands!of!Syringes! • Very!Consistent!Lot!to!Lot!ProducNon! • SingleEUse!Sterile!Bag!Processing! Eliminates!Cleaning!Steps,!Reduces! Infrastructure!and!Increases!Capacity!
- 25. Bener!Implant!Material:!Why?!! • Isolated!Purified!Components! o Source!Tissues!Purified!to!Soluble!Component!Form!! o Memory!of!Source!Tissue!Type!Removed!! • Precludes!Wrong!Tissue!Response!e.g.,!Cadaveric!Tissue!! o No!Inflammatory!or!Foreign!Body!Response!! • Comprised!of!Collagen,!ElasNn!&!Heparin! o Same!Components!As!Natural!Extracellular!Matrix! • Components!SelfEAssemble!=!BiocoacervaNon! o Forms!Insoluble!Matrix!–!Slippery,!Wet,!Permeable,!Durable!&!Resilient! o Mimics!Natural!Precursor!Scaffold!in!ComposiNon,!Structure!&!HydraNon! o Promotes!NeovascularizaNon!&!is!NonEClo~ng! o Facilitates!Cellular!IntegraNon!&!RegeneraNon!of!FuncNonal!Tissue! • Flexible!&!Adjustable!Biomaterial!Plavorm!! o Modifying!ComposiNon!&!Components!Adjusts!Material!CharacterisNcs! !
- 28. CosmetaLife®!(Injected!Dermal!Filler)! 100 um Par0cles&in&Saline& Inverted&Microscope! • $1.3B!WW!Dermal!Filler!Market! • Growing!Market!10E15%!CAGR! • Successful!150!PaNent!Pivotal! Clinical!Trial! o Met!FDA!Primary!Efficacy!Goal!! o No!Different!Than!Restylane!! o SplitEFace!Nasolabial!Fold! CorrecNon! o Next!Step:!PMA!Submission!
- 29. Pivotal!Clinical!Trial!Results:!! PaNents!Preferred!CosmetaLife™ CosmetaLife!dermal!filler! injected!into!one!side!and! Restylane!(Control)! injected!into!other!side!of! each!face.!Blinded!Subjects! scored!each!nasoElabial! fold!using!the!Global! AestheNc!Improvement! Scale!and!preferred!GelE Del’s!product!at!all!Nme! points.! Details!found!at:! www.clinicaltrials.gov! NCT00414544!CosmetaLife 0! 20! 40! 60! 80! 100! 3EMos! 6EMos! 9EMos! 12Emos! CosmetaLIfe! Restylane! Global&Aesthe0c&Improvement&Scale&–&Subject&Scored& IniNal!10!subjects!per!site!excluded.!Approximately!80!Subjects! ! !
- 30. Dermal!Filler!Market!&!Comps! • $1.3B!WW!Dermal!Filler!Market1! • 10E15%!CAGR! • Our!comp!group!consists!of!other!dermal!filler! manufactures!and!distributors! o Valeant/Nestle!May!2014!transacNon!($1.4B,!or!more!than! 5.0x!sales)!! o Allergan!trades!at!over!7.0x!2014!E!sales! ! ! ! 1WW!Dermal!Filler!Market!is!an!average!of!the!following:! !!!Allergan:!2013!WW!Filler!Market!$1.3B,!CAGR!10%!(5/12/2014)! !!!Market!Research!Reports:!2013!WW!Filler!Market!$1.0B,!CAGR!15%!(6/17/14)! !
- 31. AddiNonal!Human!ParNcle!Devices!&!Markets! • SynovoLife!–!Synovial!Joint!InjecNon!for!OsteoarthriNs!!! • 6M!(7%)!in!US!SymptomaNc!Knee!OsteoarthriNs!between!age!50!to!84!years(1)! • No!EffecNve!ReparaNve!Treatment;!Symptom!Treatment!or!Joint!Replacement! • CosmetaLife!–!Lip!Dermal!Filler! • Extension!of!Dermal!Filler!With!An!IndicaNon!Specifically!For!Lip!Plumping! • Current!Lip!Treatments!Either!Cause!Scarring!or!Dissipate!! • DiscLife!–!Spinal!Disc!Repair!!! • More!Than!10%!of!US!Adults!Have!Chronic!Low!Back!Pain(2)! • InjecNon!of!ParNcles!Into!Spinal!Disc!To!Expand/Repair!Disc!&!Relieve!Pain!! • UroLife!–!Female!Urinary!InconNnence!! • ParNcles!Injected!Into!The!Bladder!Wall!Around!the!Urinary!Sphincter!to!Provide! RegeneraNve!Tissue!Bulking!to!Stop!Urinary!Leakage! • Current!Therapies!of!Limited!EffecNveness,!O{en!Require!Daily!MedicaNons! • 18.7%!of!Adult!Women!Affected!by!Urinary!InconNnence(3)! ! (1)!Losina!E,!Walensky!RP,!Reichmann!WM,!Holt!HL,!Gerlovin!H,!Solomon!DH,!et!al.!Impact!of!Obesity!and!Knee!OsteoarthriNs!on! 1Morbidity!!!and!Mortality!in!Older!Americans.!Ann!Intern!Med.!2011;154:217E226.!! (2)!Freburger,!Janet!K.,!et!al.!"The!rising!prevalence!of!chronic!low!back!pain."!Archives!of!Internal!Medicine!169.3!(2009):!251E258.! (3)!Ebbesen,!Marit!H.,!et!al.!"Prevalence,!incidence!and!remission!of!urinary!inconNnence!in!women:!longitudinal!data!from!the! 1Norwegian!HUNT!study!(EPINCONT)."!BMC!urology!13.1!(2013):!27.!
- 33. !Cardiovascular!Devices!&!Markets! • VasoShunt!–!Arteriovenous!(AV)!Shunt! o Annually!≈250,000!US!Dialysis!PaNents!Require!Vascular!Access!(US!Renal!Data!System)! o Over!50%!of!NaNve!&!ePTFE!Shunts!Fail!Within!1!year(1)! • VasoShunt!–!Temporary!Vascular!Shunt!for!Limb!Salvage! o Treatment!of!Vascular!Injuries!in!Military!Theatre!&!Trauma!Se~ngs! o No!Current!Temporary!Shunts!Have!NonEClo~ng!Feature!of!VasoShunt! • Peripheral!Vascular!Gra{!! o WW!Market!Growing!From!$6.6B!in!2014!to!$8.4B!in!2018!–!CAGR!of!6.3%!(BCC!Research)! o No!Peripheral!Vascular!Gra{s!with!NonEclo~ng!Features!of!VasoGra{!Available!! • Coronary!Artery!Bypass!Gra{! o 400,000!CABG!Procedures!Annually!In!US!(American!Heart!AssociaNon)! o No!OffETheEShelf!Small!Diameter!Gra{s!Currently!Available! ! (1)Akoh!JA.!ProstheNc!AV!!Gra{s!for!!Hemodialysis.!J!Vasc!Access.!2009!JulESep;10(3):137E47.!Review.!PubMed!PMID:!19670164.!
- 34. VasoGra{!&!VasoShunt!–!Biomaterial!Conduit!!!! NonEClo~ng!ArNficial!Blood!Vessel • $5.7!M!in!NIH!Grant!Funding! • Successful!180EDay!Swine!Studies! • Successful!Pilot!ProducNon! • Any!Type!of!Vascular!Gra{!or!Shunt!! • Bener!Than!Gold!Standard!ePTFE!Gra{s! • NonEClo~ng!ProperNes! o Devices!&!Device!CoaNngs! o Improve!Any!Blood!ContacNng!Device! o Stents,!Gra{s,!Catheters,!etc.! o Allows!Small!Diameter!Gra{s! • Inherent!Drug!Delivery!Capability! ! CaroNd! artery! VasoShunt! 2!wk!implantaNon!(ovine)! VasoShunt! End!to!side!anastomosis!with!12!cm!long!VasoE!!! Gra{!shunNng!caroNd!to!jugular!in!sheep!(n=6)!
- 35. !Shunt!–!tube!of!biomaterial VasoShunt:!U.S.!Dept.!of!Defense!Porcine!Clo~ng!Study! • Length!was!5!mm!i.d.!and!5E6!cm!long!(wall!thickness!matches!natural! blood!vessel)! • Able!to!shunt!severed!iliac!artery!for!4–5!hours!without!clo~ng! (hemocompaNble)!! • 3.8!mm!ID!small!diameter!gra{s!patent!for!over!6!months!in!porcine! femoral!artery! Conclusion:!VasoShunt!shows! great!promise!for!short!term! circulatory!reconnecNon!of! severed!vessels!in!military! trauma!applicaNons! Biomaterial!is!hemocompatable!and! structurally!sound!! VasoShunt! NaNve! Artery! iliac artery shunt!