UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO SECTION 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

 

June 6, 2017

 

001-36686

(Commission file number)

 

 

Forward Pharma A/S

(Translation of registrant’s name into English)

 

 

Østergade 24A, 1st Floor

1100 Copenhagen K, Denmark

(Address of principal executive office)

 

________________________________________

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F [ X ] Form 40-F [ ]

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): Yes [ ] No [ X ]

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): Yes [ ] No [ X ]

 

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes [ ] No [ X ]

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): N/A

 

 

Item 1 Company Presentation

 

On June 6, 2017, Forward Pharma A/S (the “Company”) made available on its website a copy of an investor presentation that was also being presented at the Jefferies 2017 Global Healthcare Conference. A copy of this presentation is filed herewith as Exhibit 99.1

 

The fact that this presentation is being made available and filed herewith should not be deemed an admission as to the materiality of any information contained in the materials. The information contained in the presentation is being provided as of June 6, 2017 and the Company does not undertake any obligation to update the presentation in the future or to update forward-looking statements to reflect subsequent actual results.

 

 

 

 

SIGNATURE

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

             
Date:  June 6, 2017       Forward Pharma A/S
     

 

 

        By:   /s/ Claus Bo Svendsen
            Name: Claus Bo Svendsen
            Title: Chief Executive Officer

Exhibit 99.1

 

 

 

Forward Pharma (NASDAQ:FWP) CorporateUpdate Jefferies 2017 Global HealthcareConference June 6,2017 2017© Forward PharmaA/S. Claus Bo Svendsen, MD,PhD Chief ExecutiveOfficer

 
 

Forward-LookingStatements 2 2017© Forward PharmaA/S. Certainstatementsinthispresentationmayconstitute“forward-lookingstatements”ofForwardPharmaA/S(the “Company”)withinthemeaningofthePrivateSecuritiesLitigationReformActof1995.Forward-lookingstatements include, but are not limited to, statementswhich containlanguage such as “believe”,“expect”,“anticipate”, “estimate”,“would”,“may”,and“potential”.Forward-lookingstatementsarepredictionsonly,whichinvolveknown andunknownrisks,uncertaintiesandotherfactorsthatmaycauseactualresultstobemateriallydifferentfromthose expressedinsuchstatements.Manysuchrisks,uncertaintiesandotherfactorsaretakenintoaccountaspart ofour assumptionsunderlyingtheseforward-lookingstatementsandinclude,amongothers,risksrelatedtothe following: thesatisfactionofcertainconditions,andtheaccuracyofcertainrepresentationsoftheCompany,inthe Settlement andLicenseAgreemententeredintowithsubsidiariesofBiogenInc.andcertainotherpartiesthereto; ourabilityto obtain,maintain,enforceanddefendissuedpatentswithroyalty-bearingclaims;ourabilitytoprevailin the interferenceproceedingafterallappealsandobtainissuanceofthe’871application;ourabilitytoprevailinorobtain afavorabledecisioninthe‘355Europeanoppositionproceedings,afterallappeals;theexpectedtimingfor key activitiesandanultimaterulinginsuchlegalproceedings;theissuanceandtermofourpatents;futuresalesof Tecfidera ® ,includingimpactonsuchsalesfromcompetition,genericchallenges,regulatoryinvolvementandpricing pressures;thescope,validityandenforceabilityofourintellectualpropertyrightsingeneralandtheimpactonusof patentsandotherintellectualpropertyrightsofthirdparties;thetiming,amount(ifany)andtaxconsequencesof anydistributiontoshareholders;thetimingforanyplannedannouncementsofsuchdistributionplans;andourability togeneraterevenuefromproductsalesintheU.S.directlyorthroughanassigneeofourU.S.co-exclusive license rightsintheeventBiogendoesnotobtainanexclusivelicensefromusintheU.S.Certainoftheseandother risk factorsareidentifiedanddescribedindetailincertainofourfilingswiththeUnitedStatesSecuritiesand Exchange Commission,includingourAnnualReportonForm20-FfortheyearendedDecember31,2016.Weareprovidingthis informationasofthedateofthisreleaseanddonotundertakeanyobligationtoupdateanyforward- looking statementscontainedinthispresentationasaresultofnewinformation,futureeventsorotherwise.

 
 

ExecutiveSummary 3 2017© Forward PharmaA/S. ?Forward has developed a significant IP portfolio related todimethyl fumarate(DMF) ?Forward operates as a lean organization with five employees byQ4/2017 ?Forward has granted to Biogen an irrevocable license to all of itsIP related to DMF through the recent Settlement and LicenseAgreement ?Forward’s pro forma cash balance is $1.09 B ?Forward will receive royalties on sales of Tecfidera® or other DMF products for MS from Biogen of up to 10 –20% from January 1,2021, provided that, among other factors (a,b) , qualifiers aremet: ? US Royalties:Outcome of US interference including all appeals and Hart-Scott- Rodino (HSR) antitrustclearance ? Ex-US Royalties:Outcome of European EP‘355 opposition including allappeals (a) Subjectto, amongotherthings, expirationorinvalidationofthepatentsorimpactofgenericentry (b) Royaltiespayableonacountry-by-countrybasison DMF-containingproductsindicatedforMSthat,butfortheLicenseAgreement,wouldinfringeaForwardlicensedpatent

 
 

Forward has Actively Developed FP187 since2005 Forward Pharma founded Biogen agreement IPO FWP on NASDAQ $235M Early preclinical,CMC and clinicalwork Proof-of- Concept in psoriasis US Patent interference declared EP‘355 Patent* granted USErosion Matrix Patent* issued Phase 3 trialplanning *Forwardistheownerof numerousotherpatents/patentapplications;forasummaryofsomeofthese,pleaseseeseparateslide‘Key IPOverview’ 4 2017© Forward PharmaA/S.

 
 

Share Value Drivers under the Settlement and LicenseAgreement Not meant to be comprehensive; size of boxes is arbitrary and not meant to illustrate comparative differences in amounts. Appropriate risk-adjustment should be applied. Potential investors and current shareholders are strongly urged to read the Settlement and License Agreement in its entirety as well as our Annual Report on Form 20-F for the year ended December 31, 2016, where risk factors are identified and described indetail. NetCash + Value of Potential Royalties from US salesof Tecfidera® + Value of Potential Royalties from ex-US salesof Tecfidera® - Operational Cash Burn (low) Tecfidera® USSales Tecfidera® ex-USSales 5 2017© Forward PharmaA/S.

 
 

Share Value Drivers under the Settlement and LicenseAgreement NetCash + Value of Potential Royalties from US salesof Tecfidera® + Value of Potential Royalties from ex-US salesof Tecfidera® - Operational Cash Burn (low) Tecfidera® USSales Tecfidera® ex-USSales Not meant to be comprehensive; size of boxes is arbitrary and not meant to illustrate comparative differences in amounts. Appropriate risk-adjustment should be applied. Potential investors and current shareholders are strongly urged to read the Settlement and License Agreement in its entirety as well as our Annual Report on Form 20-F for the year ended December 31, 2016, where risk factors are identified and described indetail. 6 2017© Forward PharmaA/S.

 
 

Cash Balance andOperations 7 2017© Forward PharmaA/S. BalanceSheet December 31,2016 Pro forma forpost- tax receipt of Biogenpayment (a) Cash andInvestments $138.7M $1,093.7M (a) $138.7 M cash balance plus $1.25 B cash fee less $25 M payment to Aditech Pharma AG and estimated taxes of $270M ▪ Organization to be five employees byQ4/2017 ▪ Market Cap (NASDAQ: FWP; per May 31,2017): $929.5M

 
 

Upfront Fee fromBiogen 8 2017© Forward PharmaA/S. ?Forward is currently evaluating different means to return to shareholders a substantial portion of the $1.25B* ?Potential vehicles being considered for the return of capitalinclude ?Distributions/dividends ?Stockbuybacks ?Othermeans * We have not paid any dividends since our incorporation and may not do so in the future. Our management is currently evaluating different means to deliver to our shareholders an undetermined amount of capital, however we have made no decision to do so and may not do so. Should we decide to do so, such return of capital may involve dividends, distributions, share repurchases or other means. The final determination as to any return of capital will be at the discretion of our board of directors, after taking into account various factors including our business prospects, cash requirements, outcome of the Interference and Opposition Proceedings includinganyappeals,andourobligationsundertheSettlementandLicenseAgreement.Alternatively,theboardmayconsiderotheroptionsformaximizingshareholdervalue.

 
 

Share Value Drivers under the Settlement and LicenseAgreement NetCash + Value of Potential Royalties from US salesof Tecfidera® + Value of Potential Royalties from ex-US salesof Tecfidera® - Operational Cash Burn (low) Tecfidera® USSales Tecfidera® ex-USSales Not meant to be comprehensive; size of boxes is arbitrary and not meant to illustrate comparative differences in amounts. Appropriate risk-adjustment should be applied. Potential investors and current shareholders are strongly urged to read the Settlement and License Agreement in its entirety as well as our Annual Report on Form 20-F for the year ended December 31, 2016, where risk factors are identified and described indetail. 9 2017© Forward PharmaA/S.

 
 

Gating Events for Royaltieson Tecfidera®Sales US Ex-US US Royalties as described onnextslide Ex-US Royalties as described on nextslide ThesummaryoftheSettlementandLicenseAgreementinthispresentationdoesnotpurporttobecompleteandissubjectto,andqualifiedinitsentiretyby,thefulltext oftheSettlementandLicenseAgreement,whichisavailableonForward’swebsite.PotentialinvestorsandcurrentshareholdersarestronglyurgedtoreadtheSettlement andLicenseAgreementinitsentiretyaswellasourAnnualReportonForm20-FfortheyearendedDecember31,2016. 10 2017© Forward PharmaA/S. Gatingevent If we prevail after all appeals to the Federal Circuit in the Interference Proceeding and as a result thereof obtain issuance of a patent with a claim that covers treatment for MS by orally administering 480 mg per day ofDMF Gatingevent If we prevail in the EP’355 Opposition, including any appeals and as a result thereof obtain issuance of a patent with a claim that covers treatment for MS by orally administering 480 mg per day ofDMF

 
 

Potential Royalty Rateson Tecfidera®Sales HSR antitrustclearance (a) Subjectto, amongotherthings, expirationorinvalidationofthepatentsorimpactofgenericentry (b) Royaltiespayableonacountry-by-countrybasison DMF-containingproductsindicatedforMSthat,butfortheLicenseAgreement,wouldinfringeaForwardlicensedpatent Royalty (a,b) Yes No BackupScenario: Exclusivelicense January 1, 2021 until December 31,2028: January 1, 2029 andafter: 10% 20% Co-exclusivelicense January1,2023andafter: 1% FWP retains right to develop and commercialize or outlicense FP187 or another DMF-containing formulation, on one occasion only, to a single third party Royalty (a,b) US Ex-US Royalty (a,b) Exclusivelicense January 1, 2021 until December 31,2028: January 1, 2029 andafter: 10% 20% 11 2017© Forward PharmaA/S.

 
 

USPTO InterferenceProceeding 12 2017© Forward PharmaA/S. ?Interference declared April 13,2015 ApatentinterferenceisanadministrativeproceedingattheUSPTOusedto determinewhichpartyisthefirsttoinventacommoninventionclaimedby bothparties. ?Forward awarded “Senior Party” status The Senior Party has the earliest effective filing date to the common invention; entitled to the presumption that it is the firstinventor. ?On March 31, 2017, the USPTO PTAB ruled in favor ofBiogen ?ForwardisappealingtherulingtotheU.S.CourtofAppealsforthe FederalCircuitwithaspecialistteamledbyKathleenSullivanfrom QuinnEmanuelUrquhart&Sullivan,LLP

 
 

European EP‘355 OppositionProceedings 13 2017© Forward PharmaA/S. ?EP2801355 patent granted by European Patent Office (EPO) on May 20,2015 ?Subject to several oppositions filed with the EPO by thirdparties (includingBiogen) ?The first instance hearing of the Opposition Proceedings in the EPO has been scheduled for January 22-23, 2018, but the date is subject tochange

 
 

Share Value Drivers under the Settlement and LicenseAgreement NetCash + Value of Potential Royalties from US salesof Tecfidera® + Value of Potential Royalties from ex-US salesof Tecfidera® - Operational Cash Burn (low) Tecfidera®Sales Tecfidera® USSales Tecfidera® ex-USSales 14 2017© Forward PharmaA/S. Not meant to be comprehensive; size of boxes is arbitrary and not meant to illustrate comparative differences in amounts. Appropriate risk-adjustment should be applied. Potential investors and current shareholders are strongly urged to read the Settlement and License Agreement in its entirety as well as our Annual Report on Form 20-F for the year ended December 31, 2016, where risk factors are identified and described indetail.

 
 

Tecfidera®: ~$4 B in Global Sales in2016 ?2016 Global Sales of ~$4 B are forecasted to grow to $4.46 B in 2022, remaining the top selling MStherapy Analyst Consensus Forecast, EvaluatePharma, May 31,2017 USSales: ~75% 15 2017© Forward PharmaA/S. Ex-USSales: ~25%

 
 

Risk-Reward guides the choice of therapy inMS Increasing Burden ofTreatment I n c r e a s i n g E f f i c a c y Autologous Stem CellTransplantation Dimethyl Fumarate Glatiramer Acetate Interferon-B Teriflunomide Daclizumab Ocrelizumab Natalizumab JCNegative Alemtuzumab Natalizumab JCPositive Mitoxantrone Fingolimod Adapted from Coles A, Newer therapies for multiple sclerosis. Ann Indian Acad Neurol 2015;18, Suppl S1:30-4 16 2017© Forward PharmaA/S.

 
 

Factors Influencing Future Tecfidera®Sales 17 2017© Forward PharmaA/S. ?Regulatory Data Exclusivity and PatentProtection ?Settlement and License Agreement adds Forward PharmaIP ?Launch ofOcrevus® ?BasedonanalystreportsandinterviewswithEUandUSKOLs,Ocrevus®is estimatedtoinitiallyconvertlaterstagepatientsoninjectablesandadda ProgressiveMSmarket ?Potential Generic Fingolimod and additional S1Pmodulators

 
 

Share Value Drivers under the Settlement and LicenseAgreement NetCash + Value of Potential Royalties from US salesof Tecfidera® + Value of Potential Royalties from ex-US salesof Tecfidera® - Operational Cash Burn (low) Tecfidera® USSales Tecfidera® ex-USSales Forward has Significant Capital Resources, a Focused Organization, and IP-TriggeredOptionality 18 2017© Forward PharmaA/S. Not meant to be comprehensive; size of boxes is arbitrary and not meant to illustrate comparative differences in amounts. Appropriate risk-adjustment should be applied. Potential investors and current shareholders are strongly urged to read the Settlement and License Agreement in its entirety as well as our Annual Report on Form 20-F for the year ended December 31, 2016, where risk factors are identified and described indetail.

 
 

UpcomingEvents 19 2017© Forward PharmaA/S. ?Ongoing organizational alignment andoptimization ?Ongoing evaluation of the most efficient way to deliver to shareholders a substantial portion of the $1.25 B cash payment received fromBiogen ?Gating events for future royalty from Tecfidera®sales ?Appeal of US PTAB interference decision to FederalCircuit ? If the PTAB decision is reversed or vacated by the Federal Circuit, then potentially further proceedings in the PTAB and a subsequent additional appeal to the FederalCircuit ?EU EP‘355 oppositiondecision ? Potential appeal of oppositiondecision

 
 

Contact 20 2017© Forward PharmaA/S. Claus Bo Svendsen, MD, PhD Chief ExecutiveOfficer Forward Pharma InvestorRelations investors@forward-pharma.com

 
 

Appendix 21 2017© Forward PharmaA/S.

 
 

US Potential Royalty-BearingClaims 22 2017© Forward PharmaA/S. Application Number Description U S 11/576,871 Treating MS with DMF at 480mg/day Interference declared; FWP as Senior Party –April 13, 2015 PTAB ruled in favor of Biogen –March 31,2017 Appeal to the Federal Circuitfiled 15/581,966 Claims to up-titration of DMF to 480 mg/day for the treatment of MS to befiled. 14/212,503 Treating MS with DMF at 480 mg/day to reach certain MMF levels in the bloodstream Final rejection issued; appeal brief filed May 16,2016 14/209,480 Pharmaceutical composition comprising DMF in an amount of 50-90% by weight Non-final rejection issued April 11,2017 4 patent applications that, if issued, contain claims that may be royalty-bearing if Forward prevails after all appeals in the interferenceproceeding IfweprevailintheInterferenceProceedingafteranyappealstotheFederalCircuit,wefurtherexpectour11/576,871application,ifultimatelyissued,would beentitledtopatenttermadjustmentthatwouldresultinanestimatedpatentexpirationin2029orlater.Thereisnoassurancethatwewouldobtainpatent termadjustmenttofullycompensateusforallsuchtimelost.

 
 

Timeline for Appeal of the Interference Decision to the FederalCircuit Forward Pharma Noticeof Appeal Expected Decision Forward Pharma Appeal Brief Expected Oral Argument Forward Pharma Reply Brief Biogen Responsive Brief 60 days after Notice of Appeal is docketed and certified list is servedby USPTO 40 days after ForwardPharma AppealBrief 14 days Dates represent estimates of when filings are due to the Federal Circuit; a green tick mark signifies completed filing. Documents can be located through https://ecf.cafc.uscourts.gov/ 23 2017© Forward PharmaA/S.

 
 

Ex-US Potential Royalty-BearingClaims 24 2017© Forward PharmaA/S. Application Number Description E x - U S EP14172398.1 (Pat. No. EP2801355) Treating MS with 480 mg/day of DMF wherein the pH controlled release compositions have an entericcoat Granted –May 20, 2015; Opposition hearing before EPOcurrently scheduled for 22-23 January2018 EP15166243.4 (Pat. No. EP2965751) Treating MS with 480-600 mg fumaric acid esters (including DMF)/day where the composition releases fumaric acid esters depending onpH. Applicationpending EP14172396.5 (Pat.No. EP2792349) Treating MS with 480 mg/day of controlled releaseDMF EPO issued intention to grant –February 8,2017 EP16001391.8 (Pat. No. EP3093012) Controlled release pharmaceutical composition comprising DMF inan amount of 50-90% byweight EPO issued intention to grant –May 8,2017 If Forward prevails in the European EP‘355 opposition proceedings including all appeals, and can show on a country-by-country basis that Tecfidera® infringes a valid patent, royalties will be payable. In Europe, there are four patent applications with potentially royalty-bearingclaims.

 
 

Key IPOverview: Core Composition and Erosion Matrix PatentFamilies 1 25 2017© Forward PharmaA/S. Patent /Application PatentFamily Status U.S. App.11/576,871 CoreComposition Pending. A decision was issued by the PTAB on March 31, 2017 in favor ofBiogen. We have filed an appeal of the decision to the FederalCircuit. U.S. App.15/581,966 CoreComposition Pending. U.S. App.14/212,503 CoreComposition On appeal from finalrejection. U.S. App.14/209,480 CoreComposition Pending. Non-final rejection issued in April2017. EP2801355 CoreComposition Granted. Under opposition withEPO. EP1799196 CoreComposition Granted. Under opposition withEPO. EP2801354 CoreComposition Granted. EP2316430 CoreComposition Revoked by decision of July 10, 2015; underappeal. EP3093012 CoreComposition Pending. Intention to grantissued. EP2965751 CoreComposition Pending. EP2792349 CoreComposition Pending. Intention to grantissued. JP2015-139809 CoreComposition Pending. U.S. Patent No.8,906,420 ErosionMatrix Granted. U.S. App.14/561,010 ErosionMatrix Pending. Final rejection issued in March2017. EP2379063 ErosionMatrix Granted; opposition rejected; appealpending. EP2564839 ErosionMatrix Granted. EP3090733 ErosionMatrix Pending. JP5788331 ErosionMatrix Granted asJP2012-514624. 1. Beyond our core composition patent and erosion matrix patent families, our other patent families include U.S. Patent ApplicationNos. 14/419,031, 15/584, 439 and 14/914,025 and European Patent Application Nos. EP2879672, EP3038606 andEP3038605. Date of preparation: 31 May2017