M A Y 7 , 2 0 2 4
FirstQuarter2024
FinancialResults
Safe Harbor Statementand Disclaimers
Thispresentationcontainsforward-lookingstatementsbyLigandanditspartnersthatinvolverisksanduncertaintiesandreflectLigand'sanditspartners'judgmentas ofthedateofthispresentation.Wordssuchas "plans,""believes,""expects,""anticipates,"and"will,"andsimilarexpressions,areintendedtoidentifyforward-lookingstatements.Theseforward-lookingstatementsinclude,withoutlimitation:Ligand'sabilityto expanditsportfoliowithlifesciencesroyaltyopportunities;thetimingofclinicalandregulatoryeventsofLigand'spartners;thetimingoftheinitiationorcompletionofpreclinicalstudiesandclinicaltrialsbyLigand anditspartners;thetimingofproductlaunchesbyLigandoritspartners;andguidanceregardingthefull-year2024financialresults.ActualeventsorresultsmaydifferfromLigand'sexpectationsduetorisksand uncertaintiesinherentinLigand'sbusiness,including,withoutlimitation:Ligandreliesoncollaborativepartnersformilestonepayments,royalties,materialsrevenue,contractpayments andotherrevenueprojections andmaynotreceiveexpectedrevenue;LigandmaynotreceiveexpectedrevenuefromCaptisolmaterialsales;Ligandanditspartnersmaynotbeabletotimelyorsuccessfullyadvanceanyproduct(s)initsinternal orpartneredpipelineorreceiveregulatoryapprovalandtheremaynotbeamarket fortheproduct(s)evenifsuccessfullydevelopedandapproved;Ligandmaynotachieveitsguidancefor2024;Ligandfaces competitioninacquiringroyaltiesandlocatingsuitableroyaltiestoacquire;Ligandmaynotbeabletocreatefuturerevenuesandcashflowsbydevelopinginnovativetherapeutics;resultsofanyclinicalstudymay notbetimely,favorableorconfirmedbylaterstudies;thetotaladdressablemarket forourpartners'productsmaybesmallerthanestimated;Ligandfacescompetitionwithrespecttoitstechnologyplatforms whichmaydemonstrategreatermarketacceptanceorsuperiority;LigandiscurrentlydependentonasinglesourcesolesupplierforCaptisolandfailuresbysuchsuppliermayresultindelaysorinabilitytomeetthe Captisoldemandsofitspartners;Ligand'spartnersmaychangetheirdevelopmentfocusandmaynotexecuteontheirsalesandmarketingplansformarketedproductsforwhichLigandhasaneconomicinterest; Ligand'sanditspartners'productsmaynotbeprovedtobesafeandefficaciousandmaynotperformas expectedanduncertaintyregardingthecommercialperformanceofsuchproducts;Ligandoritspartners maynotbeabletoprotecttheirintellectualpropertyandpatentscoveringcertainproductsandtechnologiesmaybechallengedorinvalidated;Ligand'spartnersmayterminateanyofitsagreementsor developmentorcommercializationofanyofitsproducts;Ligandanditspartnersmayexperiencedelaysinthecommencement,enrollment,completionoranalysisofclinicaltestingforitsproductcandidates,or significantissuesregardingtheadequacyofitsclinicaltrialdesignsortheexecutionofitsclinicaltrials;challenges,costsandchargesassociatedwithintegratingacquisitionswithLigand'sexistingbusinesses; Ligand/PelthosTherapeuticsmaynotbeabletosuccessfullycommercializeZELSUVMI(berdazimer) andmaynotbeabletooutlicenseorsellthisassetsuccessfully;Ligandmaynotbeabletosuccessfully implementitsstrategicgrowthplanandcontinuethedevelopmentofitsproprietaryprograms;thepotentialimpactofsix Agenuspartneredprograms,includingBMS-986442(BristolMyersSquibb),AGEN2373(GileadSciences),INCAGN2385andINCAGN2390(Incyte),MK-4830(Merck),andUGN-301(UroGenPharma);thetrialandregulatorysuccessofAgenus'upcomingPhase3trialofbotensilimabincombinationwithbalstilimab("BOT/BAL")forpatientswithmetastatic,refractorycolorectalcancerthatisnotMSI-H/dMMRandwhodonothavelivermetastases; thetimingandamountsofroyaltypayments dueundertheroyalty financingagreementwithAgenus;restrictionsunderLigand'screditagreementmaylimititsflexibilityinoperatingitsbusinessandadefaultundertheagreementcouldresultinaforeclosureofthecollateralsecuring suchobligations;changesingeneraleconomicconditions,includingasaresultofwar,conflictorepidemicdiseases;ongoingorfuturelitigationcouldexposeLigandtosignificantliabilitiesandhaveamaterial adverseeffectonthecompany;andotherrisksanduncertaintiesdescribedinitspublicfilingswiththeSecuritiesandExchangeCommission(the"SEC"),availableatwww.sec.gov.Informationregardingpartnered productsandprograms comesfrominformationpubliclyreleasedbyourpartners.Ourtrademarks,tradenamesandservicemarks referencedhereinincludeLigand,CaptisolandZELSUVMI,aNovanproduct.Each othertrademark,tradenameorservicemarkappearinginthispresentationbelongstoitsowner.
Theprocessforreconciliationbetweenthenon-GAAPadjustedfinancialnumberspresentedonslides16and 17 andcorrespondingGAAPfiguresisshownintheearningspressreleaseforthequarterendedMarch 31,2024,availableathttps://investor.ligand.com/press-releases. However,otherthanwithrespecttototalrevenues,theCompanyonlyprovidesfinancialguidanceonanadjustedbasisanddoesnotprovide reconciliationsofsuchforward-lookingadjustedmeasurestoGAAPduetotheinherentdifficultyinforecastingandquantifyingcertainamountsthatarenecessaryforsuchreconciliation.
Readersarecautionednottoplaceunduerelianceontheseforward-lookingstatements,whichreflectourgoodfaithbeliefs(orthoseoftheindicatedthirdparties)andspeakonlyasofthedatehereof.Allforward lookingstatementsarequalifiedintheirentiretybythiscautionarystatement,andLigandundertakesnoobligationtoreviseorupdatethispresentationtoreflecteventsorcircumstancesorupdatethirdparty researchnumbersafterthedatehereof.ThiscautionismadeunderthesafeharborprovisionsofSection21EoftheSecuritiesExchangeActof1934.
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Great StartTo 2024
FINANCIAL
Strong financialperformance
Strong balance sheet with $311M in cash and investments ($82M in VKTX) at 3/31/24 Announced Agenus royalty monetization & project finance investment today Reiterating 2024 revenue and earnings guidance, on continued growth trajectory
PELTHOS THERAPEUTICS
Processunderway to commercialize
Pelthos Therapeutics formed to accelerate Zelsuvmi commercialization Scott Plesha appointed Chief Executive Officer, established BOD Employing similar strategy used with Viking, Primrose and OmniAb
PORTFOLIO
Importantcatalystsin 2024
Filspari EMA Conditional Approval Merck's V116 - PDUFA date June 17, 2024 Verona's ensifentrine - PDUFA date June 26, 2024
STRATEGIC DIFFERENTIATION
Financials,advantage,team
Long-term royalty revenue CAGR >20%, adjusted EPS>25% Inefficient market with inexhaustible demand for capital
Track record of accomplishments, building a diversified portfolio
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Ligand Strategic Differentiation
STRONG FINANCIALS
High-margin /high-growth strategy
Superior P&L, low op-ex with lean operations, high profits per employee
Predictable and diversified growth
ADVANTAGEOUS STRATEGY
High Demand: Inefficient market with inexhaustible demand for capital
Superior Information: Extensive due diligence and information available under confidentiality vs. public equity investing
Flexible Structures: Customized investment structures with non-dilutable interests
Exclusivity: Create vs. compete for deals. Novel tactics / structures enable high volume of sourcing and high investment selectivity
Scalable: Only major limitations to growth are execution and access to capital
EXPERIENCED TEAM
Track record of accomplishments, building a diversified portfolio
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Looking Ahead: 5-Year Royalty Revenue Outlook
Current Portfolio of Commercial and Late-Stage Programs + New Deals Drive Growth
Primrose &
Agenus Partnered
Programs
- Royaltyrevenuegrowthcouldexceeda20%CAGR
- Recentinvestments:Tzield willcontributein2024, Soticlestat*andZelsuvmiin2025,PalvellaMLM*in 2026/2027
- AgenusinvestmentinBOT/BAL couldcontribute royaltiesasearlyas2026*
- Addinginthefirstwaveofpotentialfuturenew investments couldincreaseroyaltyrevenuegrowth toexceeda20%CAGR
- Operatingleveragegainedfromleancorporate costsstructurecoulddriveadjustedEPSCAGR exceeding25%
$250
$200
$150
$100
$50
$0 2022
Ligand Royalty Revenue Projected Trend*
(in millions)
Palvella MLM | |||
22% | BOT/BAL | ||
CAGR | Soticlestat | ||
Zelsuvmi | |||
Tzield | Filspari |
Kyprolis, Evomela, Nexterone
Rylaze, Vaxneuvance, Pneumosil, Teriparatide
2023 | 2024 | 2025 | 2026 | 2027 | 2028 |
6%
CAGR
16% CAGR
Pelican Royalties Captisol Royalties Filspari Tzield Ensifentrine Pharm Team Future New Deals
Sell-side consensus sales estimates used to arrive at royalty revenue from commercial programs
5 | *Assumes regulatory approval which is subject to risks as described elsewhere in our filings with the SEC |
Agenus Investment Profile
Counterparty
Assets / MOAs / Phases / Marketers
Deal Type
Deal Size
Asset Value Proposition
Key Diligence Focus Areas
Agenus Bio
Agenus Asset (Royalties):
Botensilimab +/- Balstilimab "BOT/BAL" (CTLA-4 +/- PD-1, Ph 2 with potential Accelerated Approval)
Partnered Portfolio:
INCAGN-2390(TIM-3, Incyte)
INCAGN-2385(LAG-3, Incyte)
BMS-986442 (TIGIT / CD96 Bispecific, BMS)
AGEN-2373(CD-137, Gilead)
UGN-301(CTLA-4 +RTGel, UroGen)
MK-4830(ILT-4, Merck)
BOT/BAL: Project Finance
Partnered Portfolio: Royalty Monetization
$100M (Opportunity for Agenus to syndicate up to $125M; pro-rata economics )
BOT/BAL: Agenus plans to file a BLA in late-2024, offering potential near-term cash flow
BOT/BAL: Program is generating significant excitement at major conferences
Partnered Portfolio: Multiple investment opportunities in highly active I/O MOAs
Partnered Portfolio: Reputable and experienced partners
BOT/BAL: Regulatory pathway
BOT/BAL: Agenus partnership discussions and financing strategy
Partnered Programs: Probability of technical and regulatory success
Partnered Programs: Competitive dynamics in highly active indications and targets
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Agenus Investment Criteria
Time to Cash Flow
Less than 4 years from approval
- Agenus plans to submit a BLA filing in late 2024 for BOT/BAL in r/r MSS CRC NLM, which could potentially lead to royalties to Ligand beginning in 2026
- Ligand could also receive partnered program milestone payments from 2024-2026
Clinical Differentiation
Proof of concept data supports ability to address high unmet need & strong safety profile
- Clinical data indicates BOT/BAL may demonstrate substantial improvement on clinically significant endpoints including ORR, duration of response, and OS in mCRC, as well as in other tumor types
Exclusivity
7+ years of market exclusivity
- BOT/BAL and each of the partnered programs have at least 12 years of biologics exclusivity, in addition to protective IP
Structural Alignment
Counterparty with structural alignment to Ligand
- Agenus will retain significant financial and strategic interest in BOT/BAL, which Agenus is actively seeking to partner
- Each of the partnered programs are currently in the hands of companies with proven clinical and commercial capabilities
Risk-Reward
Superior risk-reward profile
- Multiple investment opportunities across 7 attractive assets and 5 strong commercial partners
- BOT/BAL has generated significant enthusiasm among KOLs and has a wide breadth of opportunity to treat solid tumors
7 r/r MSS CRC NLM: Relapsed/refractory microsatellite stable colorectal cancer with no liver metasteses
Agenus Clinical &Regulatory Outlook
BOT/BAL
- BOT is a proprietary Fc-enhancednext-generationanti-CTLA-4 antibody designed to improve magnitude of responses as compared to first- generation anti-CTLA-4 antibodies, to expand the population of patients currently benefiting from anti-CTLA-4 therapy, and to reduce adverse events that have historically led to treatment discontinuation
- BOT alone or in combination with BAL, an anti-PD-1 antibody has shown clinical responses across nine metastatic late line cancers
PARTNERED PROGRAMS
- Agenus also has milestone and royalty contracts with leading global oncology partners for 6 innovative immuno-oncologyclinical-stage products (BMS, Merck, Incyte - 2 programs, Gilead, and UroGen), offering a diversified portfolio across different targets and indications with high unmet medical needs
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ZelsuvmiOffers Highly Differentiated Profile
- High burden of untreated, highly contagious viral disease with approximately 6M pediatric patients, with >70% of children left untreated
- Zelsuvmi approved for use in patients 1 year old and older vs. competitor approval in patients 2 years old and older, highlighting Zelsuvmi's ease of treatment administration which is advantageous for both clinicians and patients
- Home administration possible in Zelsuvmi treatment versus need to visit clinician for competitor's product used only in medical office treatments
Source: Centers for Disease Control and Prevention
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Pelthos Therapeutics
Pelthos Therapeutics
- Created in April 2024 to accelerate Zelsuvmi (berdazimer gel 10.3%) commercialization
- Scott Plesha appointed Chief Executive Officer
- Ligand has a track record of successfully executing similar strategy used in Viking Therapeutics, Primrose Bio, and OmniAb
Zelsuvmi
- First and only FDA approved topical gel for molluscum contagiosum in patients ≥ 1 year old
- Rights and all assets related to Nitricil technology platform acquired from Novan, Inc. (September 2023)
- Commercialization plans underway with potential financial/strategic partners
Scott Plesha, CEO
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Ligand Pharmaceuticals Inc. published this content on 03 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 June 2024 03:52:04 UTC.