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DUBLIN, March 13, 2024 /PRNewswire/ -- The "Royalty Rates in Pharmaceutical and Biotechnology Deals" report has been added to ResearchAndMarkets.com's offering. Royalty Rates in Pharmaceutical and Biotechnology Deals is your one-stop source for providing real-deal information on hundreds of transactions, including the technology licensed, royalty rates, license fees, upfront and milestone payments. This report provides details of the latest partnering deals which disclose a royalty rate, announced in the pharmaceutical, biotechnology and diagnostic sectors. The report provides details of partnering deals disclosing royalty rates from 2010 to 2024. The report provides an overview of how and why companies enter partnering deals where a royalty is payable upon commercialization of the compound or technology. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. This report contains a comprehensive listing of all partnering deals announced since 2010 where a quantitative royalty rate has been disclosed, as recorded in the Current Agreements deals and alliances database. Each deal record and royalty disclosure is available in further detail via a link to online copy of the deal including actual contract document, where available, as submitted to the Securities Exchange Commission by companies and their partners. The initial chapters of this report provide an orientation of royalty rate trends in pharma and biotech since 2010. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in royalty rates in the pharma and biotech sectors since 2010. Chapter 3 provides a more detailed insight into the structure of a royalty rate clause and how it fits with the other financial terms of the partnering deal. Chapter 4 provides an insight into companies active in disclosing royalty rates as well as those deals attracting the highest royalty rates. Chapter 5 provides comprehensive and detailed access to deals which disclose a royalty rate since 2010 where a contract document is available. Contract documents provide an in-depth insight into the actual deal terms agreed between the parties with respect to the royalty rate. In addition the report includes a comprehensive deal directory listing of all deals where a royalty rate has been disclosed announced since 2010. Each listing is organized as a directory by company A-Z, stage of development at signing, therapeutic area, and technology type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document. The report also includes numerous table and figures that illustrate the trends in royalty rates in pharma and biotech deal making since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about royalty rates in the pharma and biotech sector. Royalty Rates in Pharmaceutical and Biotechnology Deals provides the following benefits: Understand royalty rate trends since 2010 Analysis of the structure of royalty clauses with real life case studies Browse collaboration and licensing deals which reveal a royalty rate Benchmark analysis - identify market value of transactions Financials terms - upfront, milestone, royalties Directory of deals by company A-Z, therapy focus and technology type Access contract documents - insights into deal structures Due diligence - assess suitability of your proposed deal terms for partner companies Save hundreds of hours of research time Analyzing actual contract agreements allows assessment of the following: What are the precise royalty rates granted? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Executive Summary Chapter 1 - Introduction 1.1. What are royalties? 1.2. History of royalty rates 1.3. Royalties in pharmaceuticals and biotechnology 1.4. Royalties versus revenue share 1.5. Overview of the report Chapter 2 - An overview of pharmaceutical and biotechnology royalty rates 2.1. Trends in royalty rates 2010 - 2024 2.2. How do revenue shares figure? 2.3. A review of recent literature 2.4. Royalty rates in the future Chapter 3 - The royalty clause in pharmaceutical and biotechnology deals 3.1. Partnering agreement structure 3.2. Structure of a typical royalty clause 3.3. Example royalty clauses 3.3.1. Case study 1 3.3.2. Case study 2 3.3.3. Case study 3 3.3.4. Case study 4 Chapter 4 - Companies actively disclosing royalty rates 4.1. Most active companies in disclosing royalty rates Chapter 5 - Royalty rate contract directory Explore royalty rates within the deal contract document to gain greater insight Deal directory Deal Directory - Royalty rates in deals - by company A-Z Deal Directory - Royalty rates in deals - by therapy area Deal Directory - Royalty rates in deals - by stage of development at signing Deal Directory - Royalty rates in deals - by technology type Royalty rate references Example royalty rate deal contract document List of Figures Figure 1: Trends in pharma and biotech royalty rates, 2010 - 2024 Figure 2: Components of the partnering deal structure Figure 3: Components of the partnering royalty clause Figure 4: Most active companies disclosing royalty rate 2010 - 2024 Figure 5: Licensing agreement for rhAAT - rEVO Biologics, LFB Biotechnologies Companies Mentioned 2seventy bio 3a-diagnostics 3D Medicines 4SC 23andMe Abbott Laboratories Abbvie Abeona Therapeutics Ablynx Abraxis BioScience ABVC BioPharma ACADIA Pharmaceuticals Acceleron Pharma Acelrx Pharmaceuticals Acer Therapeutics Acerus Acrotech Biopharma Actavis (acquired by Watson) Active Biomaterials Acura Pharmaceuticals Adamis Pharmaceuticals Adaptimmune ADC Therapeutics Adeona Pharmaceuticals Adial Pharmaceuticals Aditx Therapeutics Adlai Nortye Aduro BioTech Advanced Dosage Forms Advanz Pharma Advaxis Advirna Aegerion Pharmaceutical Aeglea BioTherapeutics Aerie Pharmaceuticals AEterna Zentaris Aexon Labs Affimed Therapeutics Afritex Medical Products AFT Pharmaceuticals Agenus Bio Agios Pharmaceuticals Aguettant AiBtl BioPharma AIT Therapeutics Akcea Therapeutics Akebia Therapeutics Albert Einstein College of Medicine Alchemia Alder Biopharmaceuticals Alector Alexion Pharmaceuticals Alexza Pharmaceuticals Alfasigma Alfa Wassermann Allergan Allergan (name changed from Actavis) Almirall Alnylam Pharmaceuticals Alora Pharmaceuticals Alpha Biopharma Alternavida Altman Enterprises AltrazealTrading Altum Pharmaceuticals Alvogen Amarantus BioSciences American Type Culture Collection (ATCC) Amgen Amherst Pharmaceuticals Amorfix Life Sciences Ampio Pharmaceuticals Amryt Pharma Amylin Pharmaceuticals Amyris AnaBios AnaptysBio AnGes MG Angion Biomedica AnnaMed Antares Pharma Antibe Therapeutics Antigen Express Applied Therapeutics Apricus Biosciences Aquestive Therapeutics Aradigm Aratana Therapeutics Arcellx Arch Pharmalabs Arctic Vision Arcturus Therapeutics Arcus Biosciences Ardelyx Arena Pharmaceuticals Arrowhead Pharmaceuticals Artiva Biotherapeutics Arvinas Ascendis Pharma Ascentage Pharma Ashvattha Therapeutics Assembly Biosciences Astellas Pharma Astellas Pharma Europe Asterias Biotherapeutics AstraZeneca Athenex Atossa Therapeutics Atreca Audeo Oncology Augmenta Aurigene Discovery Technologies Aurinia Pharmaceuticals Authentic Brands Group AVEO Oncology Avita Therapeutics Avivagen Axovant Gene Therapies Axsome Therapeutics Aytu BioPharma Azaya Therapeutics Azure Biotech Baker Brothers Investments BAKX Therapeutics Baliopharm BASF Baxter International Bayer Healthcare Bayer Innovation Baylor Research Institute Beam Therapeutics BeiGene Beijing Defengrei Biotechnology Belgian Volition Bellerophon Therapeutics Benitec Biopharma Besins Healthcare Beth Israel Deaconess Medical Center BetterLife Pharma Bharat Biotech BIND Biosciences BioCorRx BioCryst Pharmaceuticals Bioeq IP Biogen BioGene Technology Biohaven Pharmaceuticals BioInvent BiolineRX BioMarin Pharmaceutical BioNovion BioNTech BioNxt Solutions Biopharmex BiopharmX BioPorto Bioprocess Capital Ventures BioProspect Biostem US Biotech Investment Biotechnology Value Fund BioTime Acquisition Bioton Biovail BioZone Laboratories BioZone Pharmaceuticals Blackstone Bluebird Bio Blueprint Medicines BMV Medica Boehringer Ingelheim Bone Therapeutics Braeburn Pharmaceuticals BrainStorm Cell Therapeutics Breathtec BioMedical Brickell Biotech BridgeBio Pharma Bridge Biotherapeutics Bristol-Myers Squibb Caleco Pharma Calico Can-Fite BioPharma Cancer Prevention Pharmaceuticals Cannassure Therapeutics CanniMed Therapeutics Cann Pharmaceutical Australia Canntab Therapeutics Cannus Partners Cantex Pharmaceuticals Cara Therapeutics Cardigant Medical Cardium Therapeutics CareFusion Carna BioSciences Cary Pharmaceuticals CASI Pharmaceuticals Castle Creek Biosciences Catalent CB2 Therapeutics Celdara Medical Celgene Cell Cure Neurosciences Cellvera Cel Sci Celyad Cereal Ingredients Cerebain Biotech Cerus CGA 369 cGreen Chi-Med Chiesi Farmaceutici Chimerix Chong Kun Dang Chongqing Jingdong Pharmaceutical Cimtech Cipher Pharmaceuticals Cipla Circassia Clal Biotech Clalit Health Services Clearmind Medicine Clearside Biomedical Clemson University Cleveland BioLabs Clinigen CMIC CNS Pharmaceuticals Cocrystal Pharma Coeptis Pharmaceuticals CohBar Cohen-McNiece Foundation Coherus Biosciences Colby Pharmaceuticals Collegium Pharmaceuticals Columbia Laboratories Columbia University Common Sense Conatus Pharmaceuticals Concile Consilient Health ContraFect Coronado Biosciences Cosmofix Cosmo Pharmaceuticals Coya Therapeutics CRISPR Therapeutics Crossject Crucell CSL CTI BioPharma CTT Pharmaceutical Cullinan Oncology Cumberland Pharmaceuticals Cures Within Reach CureTech Curis Currax Pharmaceuticals CURx Pharmaceuticals Cutanea Life Sciences Cybin CymaBay Therapeutics Cypress Bioscience Cytodyn Cytokinetics Cytori Therapeutics Daewoong Pharmaceutical Daiichi Sankyo Dana-Farber Cancer Institute Dance Biopharm DAS Therapeutics Defiante Farmaceutica Denali Therapeutics DepoMed Derma Sciences Dermavant Sciences Dermin Dianomi Therapeutics Dicerna Pharmaceuticals DNA Biomedical Solutions Dr. Falk Pharma Dr. Reddy's Laboratories Dragonfly Therapeutics DRI Capital Drugs for Neglected Diseases Initiative DS Healthcare Duke University Dyax Eagle Pharmaceuticals Eagle Pharmaceuticals (US) Easton Pharmaceuticals Echo Therapeutics Ecology Coatings Eczacibasi Pharmaceuticals Eddingpharm Egalet Eisai Elencee Eli Lilly Elite Pharmaceuticals Emergent BioSolutions Emory University Enalare Therapeutics Endocyte Endo Pharmaceuticals EnGeneIC Enochian Biosciences Entera Bio Entest BioMedical EnWave Epizyme Epocal Esperion Therapeutics Eternity Healthcare Eton Pharmaceuticals Eureka Genomics EUSA Pharma Evolva Ewopharma Exact Sciences Exelixis ExScientia Eyevance Fairview Health System FasTrack Pharmaceuticals Ferozsons Laboratories Ferring Pharmaceuticals Fibrocell Science Foghorn Therapeutics Forest Laboratories Fosun Pharmaceutical Fox Chase Chemical Diversity Center Fresenius Kabi Pharmaceuticals FSD Pharma Fusion Pharmaceuticals FusionVax Galapagos Galmed Pharmaceuticals GE Healthcare Genentech Generex Biotechnology Genevant Sciences Genexine Genfit Genmab Gentium Genzyme Geron Gilead Sciences Glaukos Glenmark Generics Inc USA Glenmark Pharmaceuticals Goldfinch Bio Government of Israel GPCR Therapeutics Gravocore Grifols GSK GT Biopharma Hai Kang Life Hail First Pharma Hainan Sihuan Pharmaceutical Halo Labs Halozyme Therapeutics Hansen Medical Health Canada Healthcare Royalty Partners Health Discovery Heartseed Heat Biologics Hefei Life Science Hefei Tianhui Incubation of Technologies HekaBio Helsinn Therapeutics HemoCleanse Hemogenyx HemPup Henlius Biotech Hetero Labs HIBM Research Group Hikma Pharmaceuticals Hoffmann La Roche Hollister Biosciences Hookipa Pharma Horizon Pharma Inc Huadong Medicine HyperGenomics I-mab Icahn School of Medicine at Mount Sinai Ice + Jam Iconovo IDC-GP Pharm IDEAYA Biosciences Idera Pharmaceuticals Idorsia Idun Pharmaceuticals IGM Biosciences iMetabolic Biopharma Immugenyx Immunic ImmunityBio Immunomedics Immunomic Therapeutics Immunovative Therapies ImmVira Impax Laboratories Imprimis Pharmaceuticals In4Derm iNAP Incannex Healthcare Incuron Incyte Indiana University Infinity Pharmaceuticals InflaRx Inhibitor Therapeutics Innate Pharma Innocoll Innovate Biopharmaceuticals Innovation Pharmaceuticals Innovent Biologics Innovet Innovus Pharmaceuticals INO Therapeutics Inspiration Biopharmaceuticals Instrumentation Laboratory IntelGenx Intellia Therapeutics IntelliCell BioSciences Intellikine Internet Marketing Consortium Intrexon Intuitive Surgical Invekra Inverness Medical Innovations Ionis Pharmaceuticals Ipsen Iroko Pharmaceuticals Ironwood Pharmaceuticals Israeli National Authority for Technological Innovation Itrom Pharmaceutical Group Ivantis Jaguar Health Janssen Biotech Janssen Pharmaceuticals Jazz Pharmaceuticals JFC Technologies Jiangsu Alphamab Jiangsu Lianhuan Pharmaceuticals Jiangsu NHWA Pharmaceutical Ji Xing Pharmaceuticals John Morley Foods Joincare Pharmaceutical Journey Medical Jubilant Life Sciences Jumpcan Pharmaceutical Juniper Pharmaceuticals Junshi Biosciences Jupiter Wellness Juventas Therapeutics K2M Kadmon Pharmaceuticals Kaken Pharmaceutical Kalbe Genexine Biologics KaloBios Pharmaceuticals Karveer Meditech KemPharm Kensey Nash Kieran Murphy Kinetic Concepts Kiniksa Pharmaceuticals Kintor Kiromic Biopharma Kite Pharma Kitov Pharma Klaria Klinge Biopharma Knighton Foods Knight Therapeutics Kodiak Sciences Kowa Kraig Biocraft Laboratories KVK-Tech Kwang Dong Pharmaceutical Kymera Therapeutics Kyowa Hakko Kirin Kyverna Therapeutics L1 Systems Laboratories Acbel Lantheus Holding Launch Therapeutics Lee Moffitt Cancer Center Legend Biotech LegoChem Biosciences Level Brands LFB Biotechnologies Lifestyle Delivery Systems Ligand Pharmaceuticals Lineage Cell Therapeutics Link Health Lipidor Lipocine Lixte Biotechnology Lorna Linda University Lotus Pharmaceuticals Loxo Oncology Lubrizol Lumenis Lundbeck Lung Therapeutics MabCure Macrogenics Magenta Therapeutics MainPointe Mallinckrodt Pharmaceuticals Marvanal Marv Enterprises Massachusetts General Hospital Matrix Biomed Mayne Pharma McComb Foundation McEwen Centre for Regenerative Medicine Meda Medica Medica Avante Medical Technologies Innovation Asia Medice Arzneimittel Putter Medicines Patent Pool Foundation Medicox MediGene Medigus MedImmune Medison Pharma Medivation Medivir Medovex MEI Pharma Melmed Memory Dx Mercer University Merck and Co Merck KGaA Merck Serono Merus Methodist Hospital Houston Micromet Mikah Pharma Millennium Mimi's Rock Mindset Pharma Ministry of Health Labor and Welfare MiNK Therapeutics Miraculins Miralogx Mira Pharmaceuticals Miromatrix Medical Mitsubishi Tanabe Pharma Moderna Modis Therapeutics Moleculin Biotech Mologen Momenta Pharmaceuticals Monash University Monopar Therapeutics Morgan Stanley MorphoSys Mount Sinai Health System MultiCell Immunotherapeutics Munich Leukemia Laboratory Mylan Laboratories Mylan Pharmaceuticals Myovant Sciences NanoVibronix NanoViricides NantCell NantKwest Nantong Jinghua Pharmaceutical NantWorks Napo Pharmaceuticals Natac Biotech Natco Pharmaceuticals National Green Biomed Nektar Therapeutics Neogenomics Neotope Nephrogenex Nephros Nestle Health Science Neuraxpharm Neurocrine Biosciences NeuroRx NeuroSigma NeuroVive Pharmaceutical NeuroVive Pharmaceutical Asia NewLeaf Brands Newsoara Biopharma New York University NexMed NextCure Nextleaf Solutions Nexvet NGM Biopharmaceuticals Nicox Nkarta Therapeutics NLS Pharmaceutics Nordic Bioscience Norgine NorthStar Medical Radioisotopes Notable Labs Novadaq Technologies NovaDel Pharma Novan Novan Therapeutics Novartis Novartis Vaccines and Diagnostics Novocure Novo Nordisk Novus Biologicals NRx Pharmaceuticals Nucorion Numab Nunzi Pharmaceutical Nurix Therapeutics Nutech Medical NutraOrigin NXTGEN Nymox Pharmaceutical Oberland Capital Ocugen Oculus Innovative Sciences Ocumension Therapeutics Omeros Oncologie Oncolytics Biotech OncoMed Pharmaceuticals Onconova Therapeutics Onegevity One Way Liver Genomics (OWL) ONK Therapeutics Ono Pharmaceutical Onxeo Onyx Pharmaceuticals Opexa Therapeutics Opthea OptiBiotix OptiNose Oragenics Oramed Pharmaceuticals Orexigen Therapeutics Organovo Orgenesis Orion Orox Pharmaceuticals OrthoCyte Otsuka OvaMed Ovid Therapeutics Oxford BioMedica Oxis Biotech Oxygen Biotherapeutics OxySure Systems Oyster Point Pharma Pan-Provincial Vaccine Enterprise Parnell Pharmaceuticals Par Pharmaceutical PDL BioPharma PDS Biotechnology Penwest Pharmaceuticals Pernix Therapeutics Perugia University Pfenex Pfizer Pharmacyclics PharmaCyte Biotech PharmaMar PharmaNova Pharmastrip Philogen Phosphagenics Photocure ASA Phusion Laboratoies Phyto Nutricare Pipex Pharmaceuticals Plandai Biotechnology Pluristem Therapeutics POINT Biopharma Portola Pharmaceuticals Poseida Therapeutics Pozen PreMD Premier Biomedical Professional Compounding Centers of America Progenics Pharmaceuticals Prometic Life Sciences ProQR Therapeutics Prosidion Protagonist Therapeutics Protalix BioTherapeutics Proteonomix Prothena ProtoKinetix Pulmatrix Puma Biotechnology QED Therapeutics QRxPharma Quick Med Technologies Quigley Corporation Quoin Pharmaceuticals Rayner Surgical Reata Pharmaceuticals Recordati Recro Pharma RedHill Biopharma Reedy Creek Investments RegenaStem Regeneron Pharmaceuticals Regenxbio Regnum Relay Therapeutics Relief Therapeutics Relmada Therapeutics RenalytixAI ReNeuron Repare Therapeutics Replicel Life Sciences Repligen Reprise Biomedical Resarci Therapeutics Retrophin rEVO Biologics Revolution Medicines Rigel Pharmaceuticals RNL Bio Roche Rockefeller University Roivant Sciences Royalty Pharma RST Biomedikal Sanayi Ruthigen RXi Pharmaceuticals S2 Therapeutics SACCO Sagard Healthcare Royalty Partners Sage Therapeutics Salix Pharmaceuticals Sam Amer Sanara MedTech Sandoz Sanofi Sanofi-Aventis Sanofi-Pasteur Sanpellegrino Cosmetics Santarus Santen Pharmaceutical Sanuwave Health SA Pathology Sapientia Pharmaceuticals Sarepta Therapeutics Schrodinger Scopus BioPharma Seagen Seattle Genetics Seelos Therapeutics Sekris Biomedical Senetek Senior Paradise Sensory Cloud Seqirus Seres Therapeutics Sermonix Pharmaceutical Sesen Bio SevenScore Pharmaceuticals Shanghai Pharmaceuticals Holdings Sheba Medical Center Shenzhen BioScien Pharmaceuticals Shield Therapeutics Shionogi Shire Pharmaceuticals Shore Therapeutics Siemens Healthcare Diagnostics Sigma-Tau Sinclair Pharmaceuticals Sinobiopharma Sinopharm Sio Gene Therapies Skinvera Skyline Diagnostics Solarvest BioEnergy Soliance Soligenix Sonoma BioTherapeutics Sorrento Therapeutics Spectranetics Spencer Pharmaceutical Spinal USA St. Jude Children's Research Hospital STADA Arzneimittel Staidson (Beijing) BioPharmaceuticals Stanford University Stealth BioTherapeutics Stellar Biotechnologies St Jude Medical Stoke Therapeutics Strongbridge Biopharma Sucampo AG SUDA Pharmaceuticals Sumitomo Dainippon Pharma Sunesis Pharmaceuticals Sunovion Pharmaceuticals Sun Pharmaceutical SuperNova Diagnostics Sutro Biopharma Swedish Orphan Biovitrum SymBio Pharmaceuticals Symbollon Syndax Pharmaceuticals Synergy Strips Syntopix Tactical Relief Taiba TaiGen Biotechnology Taiho Takeda Pharmaceutical Talaris Therapeutics Tango Therapeutics Target Group Tauriga Sciences TB Alliance TearLab Technion Research and Development Foundation Teijin Telomir Pharmaceuticals Tesaro Tetra Bio-Pharma TetraLogic Pharmaceuticals Teva Pharmaceutical Industries Texas A&M University Texas Heart Institute TFF Pharmaceuticals TG Therapeutics Therakine TherapeuticsMD Theravance Theravance Biopharma The Regents of the University of California Thorne Research Threshold Pharmaceuticals TiGenix Tilray Titterington Veterinary Services Tiziana Life Sciences Tocagen TONIX Pharmaceuticals Torii Pharmaceutical TRACON Pharmaceuticals Tramorgan Transgene Travere Therapeutics Trellis Bioscience Trevena Trimedyne Trimeris TrovaGene TTFactor Tufts University Turnstone Biologics Tyme Technologies Ultragenyx Pharmaceuticals Uluru Unigene Laboratories UniQure Universal Cells University College Dublin University Health Network University of Alberta University of California University of Central Florida Research Foundation University of Colorado University of Florida Research Foundation University of Geneva University of Louisville University of Missouri University of Notre of Dame University of Pennsylvania University of Texas University of Virginia University of Western Sydney University of Zurich UOP Uppsalagruppen Medical Upstream Peripheral Technologies UroGen Pharma Valeant Pharmaceuticals ValiPharma Valneva Valor Biotherapeutics Vanderbilt University Vasomune Therapeutics Vaxent VBL Therapeutics Veloxis Pharmaceuticals Veracyte Verenium Verity Pharmaceuticals VeroScience Vertex Pharmaceuticals Vida Concepts Vifor Pharma ViiV Healthcare Virbac Viropharma VistaGen Therapeutics Vividion Therapeutics Vivus VolitionRX Voronoi Voyager Therapeutics Vyera Pharmaceuticals VYNE Therapeutics Vyrix Pharmaceuticals Watson Pharmaceuticals WAVE Life Sciences Wigen Biomedicine Wisconsin Alumni Research Foundation World Class Extractions WPD Pharmaceuticals WUGEN Xbrane Bioscience Xencor Xlife Sciences XPhyto Therapeutics XTL Biopharmaceuticals Xynomic Pharmaceuticals Yale University Yeda Research and Development Company Yeugnam University Yissum Research Development ZAI Laboratory Zalicus Zenitech Zenith Epigenetics Ziopharm Oncology Zogenix ZS Pharma Zymeworks For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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DUBLIN--( BUSINESS WIRE )--The "Royalty Rates in Pharmaceutical and Biotechnology Deals" report has been added to ResearchAndMarkets.com's offering. Royalty Rates in Pharmaceutical and Biotechnology Deals is your one-stop source for providing real-deal information on hundreds of transactions, including the technology licensed, royalty rates, license fees, upfront and milestone payments. This report provides details of the latest partnering deals which disclose a royalty rate, announced in the pharmaceutical, biotechnology and diagnostic sectors. The report provides details of partnering deals disclosing royalty rates from 2010 to 2024. The report provides an overview of how and why companies enter partnering deals where a royalty is payable upon commercialization of the compound or technology. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. This report contains a comprehensive listing of all partnering deals announced since 2010 where a quantitative royalty rate has been disclosed, as recorded in the Current Agreements deals and alliances database. Each deal record and royalty disclosure is available in further detail via a link to online copy of the deal including actual contract document, where available, as submitted to the Securities Exchange Commission by companies and their partners. The initial chapters of this report provide an orientation of royalty rate trends in pharma and biotech since 2010. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in royalty rates in the pharma and biotech sectors since 2010. Chapter 3 provides a more detailed insight into the structure of a royalty rate clause and how it fits with the other financial terms of the partnering deal. Chapter 4 provides an insight into companies active in disclosing royalty rates as well as those deals attracting the highest royalty rates. Chapter 5 provides comprehensive and detailed access to deals which disclose a royalty rate since 2010 where a contract document is available. Contract documents provide an in-depth insight into the actual deal terms agreed between the parties with respect to the royalty rate. In addition the report includes a comprehensive deal directory listing of all deals where a royalty rate has been disclosed announced since 2010. Each listing is organized as a directory by company A-Z, stage of development at signing, therapeutic area, and technology type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document. The report also includes numerous table and figures that illustrate the trends in royalty rates in pharma and biotech deal making since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about royalty rates in the pharma and biotech sector. Royalty Rates in Pharmaceutical and Biotechnology Deals provides the following benefits: Understand royalty rate trends since 2010 Analysis of the structure of royalty clauses with real life case studies Browse collaboration and licensing deals which reveal a royalty rate Benchmark analysis - identify market value of transactions Financials terms - upfront, milestone, royalties Directory of deals by company A-Z, therapy focus and technology type Access contract documents - insights into deal structures Due diligence - assess suitability of your proposed deal terms for partner companies Save hundreds of hours of research time Analyzing actual contract agreements allows assessment of the following: What are the precise royalty rates granted? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Executive Summary Chapter 1 - Introduction 1.1. What are royalties? 1.2. History of royalty rates 1.3. Royalties in pharmaceuticals and biotechnology 1.4. Royalties versus revenue share 1.5. Overview of the report Chapter 2 - An overview of pharmaceutical and biotechnology royalty rates 2.1. Trends in royalty rates 2010 - 2024 2.2. How do revenue shares figure? 2.3. A review of recent literature 2.4. Royalty rates in the future Chapter 3 - The royalty clause in pharmaceutical and biotechnology deals 3.1. Partnering agreement structure 3.2. Structure of a typical royalty clause 3.3. Example royalty clauses 3.3.1. Case study 1 3.3.2. Case study 2 3.3.3. Case study 3 3.3.4. Case study 4 Chapter 4 - Companies actively disclosing royalty rates 4.1. Most active companies in disclosing royalty rates Chapter 5 - Royalty rate contract directory Explore royalty rates within the deal contract document to gain greater insight Deal directory Deal Directory - Royalty rates in deals - by company A-Z Deal Directory - Royalty rates in deals - by therapy area Deal Directory - Royalty rates in deals - by stage of development at signing Deal Directory - Royalty rates in deals - by technology type Royalty rate references Example royalty rate deal contract document List of Figures Figure 1: Trends in pharma and biotech royalty rates, 2010 - 2024 Figure 2: Components of the partnering deal structure Figure 3: Components of the partnering royalty clause Figure 4: Most active companies disclosing royalty rate 2010 - 2024 Figure 5: Licensing agreement for rhAAT - rEVO Biologics, LFB Biotechnologies Companies Mentioned 2seventy bio 3a-diagnostics 3D Medicines 4SC 23andMe Abbott Laboratories Abbvie Abeona Therapeutics Ablynx Abraxis BioScience ABVC BioPharma ACADIA Pharmaceuticals Acceleron Pharma Acelrx Pharmaceuticals Acer Therapeutics Acerus Acrotech Biopharma Actavis (acquired by Watson) Active Biomaterials Acura Pharmaceuticals Adamis Pharmaceuticals Adaptimmune ADC Therapeutics Adeona Pharmaceuticals Adial Pharmaceuticals Aditx Therapeutics Adlai Nortye Aduro BioTech Advanced Dosage Forms Advanz Pharma Advaxis Advirna Aegerion Pharmaceutical Aeglea BioTherapeutics Aerie Pharmaceuticals AEterna Zentaris Aexon Labs Affimed Therapeutics Afritex Medical Products AFT Pharmaceuticals Agenus Bio Agios Pharmaceuticals Aguettant AiBtl BioPharma AIT Therapeutics Akcea Therapeutics Akebia Therapeutics Albert Einstein College of Medicine Alchemia Alder Biopharmaceuticals Alector Alexion Pharmaceuticals Alexza Pharmaceuticals Alfasigma Alfa Wassermann Allergan Allergan (name changed from Actavis) Almirall Alnylam Pharmaceuticals Alora Pharmaceuticals Alpha Biopharma Alternavida Altman Enterprises AltrazealTrading Altum Pharmaceuticals Alvogen Amarantus BioSciences American Type Culture Collection (ATCC) Amgen Amherst Pharmaceuticals Amorfix Life Sciences Ampio Pharmaceuticals Amryt Pharma Amylin Pharmaceuticals Amyris AnaBios AnaptysBio AnGes MG Angion Biomedica AnnaMed Antares Pharma Antibe Therapeutics Antigen Express Applied Therapeutics Apricus Biosciences Aquestive Therapeutics Aradigm Aratana Therapeutics Arcellx Arch Pharmalabs Arctic Vision Arcturus Therapeutics Arcus Biosciences Ardelyx Arena Pharmaceuticals Arrowhead Pharmaceuticals Artiva Biotherapeutics Arvinas Ascendis Pharma Ascentage Pharma Ashvattha Therapeutics Assembly Biosciences Astellas Pharma Astellas Pharma Europe Asterias Biotherapeutics AstraZeneca Athenex Atossa Therapeutics Atreca Audeo Oncology Augmenta Aurigene Discovery Technologies Aurinia Pharmaceuticals Authentic Brands Group AVEO Oncology Avita Therapeutics Avivagen Axovant Gene Therapies Axsome Therapeutics Aytu BioPharma Azaya Therapeutics Azure Biotech Baker Brothers Investments BAKX Therapeutics Baliopharm BASF Baxter International Bayer Healthcare Bayer Innovation Baylor Research Institute Beam Therapeutics BeiGene Beijing Defengrei Biotechnology Belgian Volition Bellerophon Therapeutics Benitec Biopharma Besins Healthcare Beth Israel Deaconess Medical Center BetterLife Pharma Bharat Biotech BIND Biosciences BioCorRx BioCryst Pharmaceuticals Bioeq IP Biogen BioGene Technology Biohaven Pharmaceuticals BioInvent BiolineRX BioMarin Pharmaceutical BioNovion BioNTech BioNxt Solutions Biopharmex BiopharmX BioPorto Bioprocess Capital Ventures BioProspect Biostem US Biotech Investment Biotechnology Value Fund BioTime Acquisition Bioton Biovail BioZone Laboratories BioZone Pharmaceuticals Blackstone Bluebird Bio Blueprint Medicines BMV Medica Boehringer Ingelheim Bone Therapeutics Braeburn Pharmaceuticals BrainStorm Cell Therapeutics Breathtec BioMedical Brickell Biotech BridgeBio Pharma Bridge Biotherapeutics Bristol-Myers Squibb Caleco Pharma Calico Can-Fite BioPharma Cancer Prevention Pharmaceuticals Cannassure Therapeutics CanniMed Therapeutics Cann Pharmaceutical Australia Canntab Therapeutics Cannus Partners Cantex Pharmaceuticals Cara Therapeutics Cardigant Medical Cardium Therapeutics CareFusion Carna BioSciences Cary Pharmaceuticals CASI Pharmaceuticals Castle Creek Biosciences Catalent CB2 Therapeutics Celdara Medical Celgene Cell Cure Neurosciences Cellvera Cel Sci Celyad Cereal Ingredients Cerebain Biotech Cerus CGA 369 cGreen Chi-Med Chiesi Farmaceutici Chimerix Chong Kun Dang Chongqing Jingdong Pharmaceutical Cimtech Cipher Pharmaceuticals Cipla Circassia Clal Biotech Clalit Health Services Clearmind Medicine Clearside Biomedical Clemson University Cleveland BioLabs Clinigen CMIC CNS Pharmaceuticals Cocrystal Pharma Coeptis Pharmaceuticals CohBar Cohen-McNiece Foundation Coherus Biosciences Colby Pharmaceuticals Collegium Pharmaceuticals Columbia Laboratories Columbia University Common Sense Conatus Pharmaceuticals Concile Consilient Health ContraFect Coronado Biosciences Cosmofix Cosmo Pharmaceuticals Coya Therapeutics CRISPR Therapeutics Crossject Crucell CSL CTI BioPharma CTT Pharmaceutical Cullinan Oncology Cumberland Pharmaceuticals Cures Within Reach CureTech Curis Currax Pharmaceuticals CURx Pharmaceuticals Cutanea Life Sciences Cybin CymaBay Therapeutics Cypress Bioscience Cytodyn Cytokinetics Cytori Therapeutics Daewoong Pharmaceutical Daiichi Sankyo Dana-Farber Cancer Institute Dance Biopharm DAS Therapeutics Defiante Farmaceutica Denali Therapeutics DepoMed Derma Sciences Dermavant Sciences Dermin Dianomi Therapeutics Dicerna Pharmaceuticals DNA Biomedical Solutions Dr. Falk Pharma Dr. Reddy's Laboratories Dragonfly Therapeutics DRI Capital Drugs for Neglected Diseases Initiative DS Healthcare Duke University Dyax Eagle Pharmaceuticals Eagle Pharmaceuticals (US) Easton Pharmaceuticals Echo Therapeutics Ecology Coatings Eczacibasi Pharmaceuticals Eddingpharm Egalet Eisai Elencee Eli Lilly Elite Pharmaceuticals Emergent BioSolutions Emory University Enalare Therapeutics Endocyte Endo Pharmaceuticals EnGeneIC Enochian Biosciences Entera Bio Entest BioMedical EnWave Epizyme Epocal Esperion Therapeutics Eternity Healthcare Eton Pharmaceuticals Eureka Genomics EUSA Pharma Evolva Ewopharma Exact Sciences Exelixis ExScientia Eyevance Fairview Health System FasTrack Pharmaceuticals Ferozsons Laboratories Ferring Pharmaceuticals Fibrocell Science Foghorn Therapeutics Forest Laboratories Fosun Pharmaceutical Fox Chase Chemical Diversity Center Fresenius Kabi Pharmaceuticals FSD Pharma Fusion Pharmaceuticals FusionVax Galapagos Galmed Pharmaceuticals GE Healthcare Genentech Generex Biotechnology Genevant Sciences Genexine Genfit Genmab Gentium Genzyme Geron Gilead Sciences Glaukos Glenmark Generics Inc USA Glenmark Pharmaceuticals Goldfinch Bio Government of Israel GPCR Therapeutics Gravocore Grifols GSK GT Biopharma Hai Kang Life Hail First Pharma Hainan Sihuan Pharmaceutical Halo Labs 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Kite Pharma Kitov Pharma Klaria Klinge Biopharma Knighton Foods Knight Therapeutics Kodiak Sciences Kowa Kraig Biocraft Laboratories KVK-Tech Kwang Dong Pharmaceutical Kymera Therapeutics Kyowa Hakko Kirin Kyverna Therapeutics L1 Systems Laboratories Acbel Lantheus Holding Launch Therapeutics Lee Moffitt Cancer Center Legend Biotech LegoChem Biosciences Level Brands LFB Biotechnologies Lifestyle Delivery Systems Ligand Pharmaceuticals Lineage Cell Therapeutics Link Health Lipidor Lipocine Lixte Biotechnology Lorna Linda University Lotus Pharmaceuticals Loxo Oncology Lubrizol Lumenis Lundbeck Lung Therapeutics MabCure Macrogenics Magenta Therapeutics MainPointe Mallinckrodt Pharmaceuticals Marvanal Marv Enterprises Massachusetts General Hospital Matrix Biomed Mayne Pharma McComb Foundation McEwen Centre for Regenerative Medicine Meda Medica Medica Avante Medical Technologies Innovation Asia Medice Arzneimittel Putter Medicines Patent Pool Foundation Medicox MediGene Medigus MedImmune Medison Pharma Medivation Medivir Medovex MEI Pharma Melmed Memory Dx Mercer University Merck and Co Merck KGaA Merck Serono Merus Methodist Hospital Houston Micromet Mikah Pharma Millennium Mimi's Rock Mindset Pharma Ministry of Health Labor and Welfare MiNK Therapeutics Miraculins Miralogx Mira Pharmaceuticals Miromatrix Medical Mitsubishi Tanabe Pharma Moderna Modis Therapeutics Moleculin Biotech Mologen Momenta Pharmaceuticals Monash University Monopar Therapeutics Morgan Stanley MorphoSys Mount Sinai Health System MultiCell Immunotherapeutics Munich Leukemia Laboratory Mylan Laboratories Mylan Pharmaceuticals Myovant Sciences NanoVibronix NanoViricides NantCell NantKwest Nantong Jinghua Pharmaceutical NantWorks Napo Pharmaceuticals Natac Biotech Natco Pharmaceuticals National Green Biomed Nektar Therapeutics Neogenomics Neotope Nephrogenex Nephros Nestle Health Science Neuraxpharm Neurocrine Biosciences NeuroRx NeuroSigma NeuroVive Pharmaceutical NeuroVive Pharmaceutical Asia 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LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the fourth quarter and year ended December 31, 2023. Unless otherwise stated, all comparisons are for the fourth quarter and full year 2023 compared to the fourth quarter and full year 2022. Product revenue, net consists entirely of revenue from sales of NERLYNX®, Puma’s first commercial product. Product revenue, net for the fourth quarter of 2023 was $53.2 million, compared to $53.7 million in the fourth quarter of 2022. Product revenue, net for the full year 2023 was $203.1 million, compared to $200.0 million in 2022. Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $12.3 million, or $0.26 per basic and diluted share, for the fourth quarter of 2023, compared to a net loss of $5.6 million, or $0.12 per basic and diluted share, for the fourth quarter of 2022. Net income for full year 2023 was $21.6 million, or $0.46 per basic share and $0.45 per diluted share, compared to a net income of $2,000, or $0.00 per basic and diluted share, for full year 2022. Non-GAAP adjusted net income was $14.8 million, or $0.31 per basic and diluted share, for the fourth quarter of 2023, compared to non-GAAP adjusted net loss of $3.0 million, or $0.07 per basic and diluted share, for the fourth quarter of 2022. Non-GAAP adjusted net income for full year 2023 was $31.8 million, or $0.68 per basic share and $0.67 per diluted share, compared to non-GAAP adjusted net income of $11.8 million, or $0.26 per basic and diluted share, for full year 2022. Non-GAAP adjusted net income/loss excludes stock-based compensation expense. For a reconciliation of GAAP net income/loss to non-GAAP adjusted net income/loss and GAAP net income/loss per share to non-GAAP adjusted net income/loss per share, please see the financial tables at the end of this news release. Net cash provided by operating activities for the fourth quarter of 2023 was $10.4 million, compared to $7.7 million for the fourth quarter of 2022. Net cash provided by operating activities for full year 2023 was $27.0 million, compared to net cash used in operating activities of $15.8 million for full year 2022. At December 31, 2023, Puma had cash, cash equivalents, and marketable securities of $96.0 million, compared to cash, cash equivalents, and marketable securities of $81.1 million at December 31, 2022. “We are pleased to report positive net income for both the fourth quarter and full year 2023,” said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. “NERLYNX sales in the fourth quarter were negatively impacted by the lower enrollments seen in Q3, as well as a higher than expected gross to net for the quarter. We have continued to reduce our internal expenses to account for this higher gross to net and lower Q3 enrollments, as we recognize our fiscal responsibility to continue to be net income positive in 2024. Puma also continues to execute on the clinical development of alisertib, and in February, we were pleased to initiate ALISertib in CAncer (ALISCA-Lung1), a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer.” Mr. Auerbach added, “We anticipate the following key milestones over the next 12 months: (i) presentation of biomarker studies from the randomized trial of alisertib plus fulvestrant versus alisertib alone in hormone receptor positive, HER2-negative breast cancer (H1 2024); (ii) updated data from the clinical trial of alisertib in combination with osimertinib in patients with metastatic EGFR-mutant non small cell lung cancer who have developed osimertinib resistance (H1 2024); (iii) initiation of ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2024); and (iv) interim data from ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H2 2024).” Revenue Total revenue consists of product revenue, net from sales of NERLYNX, license revenue and royalty revenue. For the fourth quarter of 2023, total revenue was $72.2 million, of which $53.2 million was product revenue, net, and $19.0 million was royalty revenue. This compares to total revenue of $65.7 million for the fourth quarter of 2022, of which $53.7 million was product revenue, net, and $12.0 million was royalty revenue. For the year ended December 31, 2023, total revenue was $235.6 million, of which $203.1 million was product revenue, net, and $32.5 million was royalty revenue. This compares to total revenue in 2022 of $228.0 million, of which $200.0 million was product revenue, net, and $28.0 million was royalty revenue. Operating Costs and Expenses Total operating costs and expenses were $57.4 million for the fourth quarter of 2023, compared to $55.7 million for the fourth quarter of 2022. Total operating costs and expenses were $203.0 million for full year 2023, compared to $204.3 million for full year 2022. Cost of Sales Cost of sales was $24.3 million for the fourth quarter of 2023, compared to $16.8 million for the fourth quarter of 2022. Cost of sales was $62.7 million for full year 2023, compared to cost of sales of $55.1 million for full year 2022. Selling, General and Administrative Expenses Selling, general and administrative (SG&A) expenses were $20.2 million for the fourth quarter of 2023, compared to $25.1 million for the fourth quarter of 2022. SG&A expenses for full year 2023 were $89.9 million, essentially unchanged from $90.0 million for full year 2022. The slight increase includes an increase in payroll and related costs of approximately $3.5 million, primarily due to a one-time $2.0 million CARES Act credit in 2022, increased compensation of $1.5 million in 2023, and a $0.9 million credit loss reserve. These increases were offset by a decrease of $4.1 million in professional fees and expenses related to consultants and contractors, as well as lower insurance expenses and administrative costs. Research and Development Expenses Research and development (R&D) expenses were $12.9 million for the fourth quarter of 2023, compared to $13.8 million for the fourth quarter of 2022. R&D expenses for full year 2023 were $50.4 million, compared to $52.2 million for full year 2022. The $1.8 million decrease in R&D expenses during full year 2023 compared to full year 2022 resulted primarily from the reduction and closure of NERLYNX clinical trial sites of approximately $4.7 million, partially offset by an increase in internal R&D expenses of approximately $3.2 million, primarily due to a tax credit recorded during the year ended December 31, 2022 under the CARES Act, without a comparable tax credit in 2023. Acquired In-Process Research and Development Expense Puma recorded acquired in-process R&D expense related to an alisertib up-front payment of $7.0 million during the year ended December 31, 2022. No similar expenses were recorded in 2023. Total Other Income (Expenses) Total other expenses were $2.0 million for the fourth quarter of 2023, compared to $15.3 million for the fourth quarter of 2022. Total other expenses were $9.9 million for full year 2023, compared to $23.2 million for full year 2022. The $13.3 million decrease in other expenses in full year 2023 resulted primarily from legal verdict expenses recorded in 2022, with no similar accruals in 2023, as well as an increase in other income related to higher interest rates in 2023. First Quarter 2024 and Full Year 2024 Financial Outlook First Quarter 2024 Full Year 2024 Net Product Revenue $38 - $40 million $183 - $190 million Royalty Revenue $2.5 - $3 million $30 - $33 million License Revenue $0 million $1 - $2 million Net Income/(Loss) $(10) - $(12) million $12 - $15 million Gross to Net Adjustment 23% - 24% 21.5% - 22.5% Conference Call Puma Biotechnology will host a conference call to discuss its fourth quarter and full year 2023 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 29, 2024. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at . A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA-Lung 1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer. To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at or by calling 1-855-816-5421. Further information about Puma Biotechnology may be found at . INDICATIONS NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting. Important Safety Information Regarding NERLYNX® (neratinib) U.S. Indication CONTRAINDICATIONS: None WARNINGS AND PRECAUTIONS: Diarrhea: Manage diarrhea through either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction. Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities. Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS: The most common adverse reactions (reported in ≥ 5% of patients) were as follows: NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection. NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or . DRUG INTERACTIONS: Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate NERLYNX by at least 3 hours with antacids. Strong CYP3A4 inhibitors: Avoid concomitant use. P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use. Strong or moderate CYP3A4 inducers: Avoid concomitant use. Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with NERLYNX. USE IN SPECIFIC POPULATIONS: Lactation: Advise women not to breastfeed. Please see Full Prescribing Information for additional safety information. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding Puma’s anticipated milestones and estimates of future financial results for the first quarter and full year 2024. All forward-looking statements involve risks and uncertainties that could cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, any adverse impact on Puma’s business or the global economy and financial markets, any changes in Puma’s product candidates’ regulatory approvals, results from Puma’s clinical trials, any litigation involving Puma, any changes to Puma’s in-licensed intellectual property and the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent filings. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law. PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS (in millions except share and per share data) Three Months Ended Twelve Months Ended December 31, December 31, 2023 2022 2023 2022 (Unaudited) (Unaudited) Revenues: Product revenue, net $ 53.2 $ 53.7 203.1 $ 200.0 License revenue — — — — Royalty revenue 19.0 12.0 32.5 28.0 Total revenue 72.2 65.7 235.6 228.0 Operating costs and expenses: Cost of sales 24.3 16.8 62.7 55.1 Selling, general and administrative 20.2 25.1 89.9 90.0 Research and development 12.9 13.8 50.4 52.2 Acquired in-process research and development — — — 7.0 Total operating costs and expenses 57.4 55.7 203.0 204.3 Income from operations 14.8 10.0 32.6 23.7 Other income (expenses): Interest income 0.7 0.6 2.6 0.8 Interest expense (3.3 ) (3.3 ) (13.3 ) (11.5 ) Legal verdict (expense) credit — (12.4 ) — (12.5 ) Other income (expense) 0.6 (0.2 ) 0.8 — Total other expenses (2.0 ) (15.3 ) (9.9 ) (23.2 ) Net income (loss) before income taxes 12.8 (5.3 ) 22.7 0.5 Income tax expense (0.5 ) (0.3 ) (1.1 ) (0.5 ) Net income (loss) $ 12.3 $ (5.6 ) $ 21.6 $ (0.0 ) Net income (loss) per share of common stock—basic $ 0.26 $ (0.12 ) $ 0.46 $ 0.00 Net income (loss) per share of common stock—diluted $ 0.26 $ (0.12 ) $ 0.45 $ 0.00 Weighted-average shares of common stock outstanding—basic 47,600,505 45,814,185 47,134,331 44,674,501 Weighted-average shares of common stock outstanding—diluted 48,040,118 45,814,185 47,550,852 44,929,998 PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES LIQUIDITY AND CAPITAL RESOURCES (in millions) December 31, December 31, 2023 2022 Cash and cash equivalents $ 84.6 $ 76.2 Marketable securities $ 11.4 $ 4.9 Working capital $ 56.8 $ 56.8 Short term debt $ 34.0 — Long term debt $ 65.7 $ 98.3 Stockholders' deficit $ 53.4 $ 21.6 Twelve Months Twelve Months Ended Ended December 31, December 31, 2023 2022 Cash provided by (used in): Operating activities $ 27.0 $ (15.8 ) Investing activities (19.1 ) 7.1 Financing activities — 12.2 Increase (decrease) in cash and cash equivalents, and restricted cash $ 7.9 $ 3.5 Use of Non-GAAP Measures In addition to operating results as calculated in accordance with GAAP, Puma uses certain non-GAAP financial measures when planning, monitoring, and evaluating operational performance. The following table presents Puma’s net income (loss) and net income (loss) per share calculated in accordance with GAAP and as adjusted to remove the impact of stock-based compensation expense. For the three months and twelve months ended December 31, 2023, stock-based compensation represented approximately 7.4% and 7.3% of operating expenses, respectively, and 6.8% and 8.3% for the same periods in 2022, in each case excluding cost of sales and acquired in-process research and development. Puma’s management believes that these non-GAAP financial measures are useful to enhance understanding of Puma’s financial performance, are more indicative of its operational performance, and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures. PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARIES Reconciliation of GAAP Net Income (Loss) to Non-GAAP Adjusted Net Income (Loss) and GAAP Net Income (Loss) Per Share to Non-GAAP Adjusted Net Income (Loss) Per Share (in millions except share and per share data) (Unaudited) Three Months Ended December 31, 2023 2022 GAAP net income (loss) $ 12.3 $ (5.6 ) Adjustments: Stock-based compensation - Selling, general and administrative 1.5 1.8 (1) Research and development 1.0 0.8 (2) Non-GAAP adjusted net income (loss) $ 14.8 $ (3.0 ) GAAP net income (loss) per share—basic $ 0.26 $ (0.12 ) Adjustment to net income (loss) (as detailed above) 0.05 0.05 Non-GAAP adjusted basic net income (loss) per share $ 0.31 (3) $ (0.07 ) (3) GAAP net income (loss) per share—diluted $ 0.26 $ (0.12 ) Adjustment to net income (loss) (as detailed above) 0.05 0.05 Non-GAAP adjusted diluted net income (loss) per share $ 0.31 (4) $ (0.07 ) (5) Twelve Months Ended December 31, 2023 2022 GAAP net income (loss) $ 21.6 $ 0.0 Adjustments: Stock-based compensation - Selling, general and administrative - 8.0 (1) Research and development - 3.8 (2) Non-GAAP adjusted net income $ 21.6 $ 11.8 GAAP net income (loss) per share—basic $ 0.46 $ 0.00 Adjustment to net income (loss) (as detailed above) 0.22 0.26 Non-GAAP adjusted basic net income per share $ 0.68 (6) $ 0.26 (6) GAAP net income (loss) per share—diluted $ 0.45 $ 0.00 Adjustment to net income (loss) (as detailed above) 0.22 0.26 Non-GAAP adjusted diluted net income per share $ 0.67 (7) $ 0.26 (7) (1) To reflect a non-cash charge to operating expense for selling, general, and administrative stock-based compensation. (2) To reflect a non-cash charge to operating expense for research and development stock-based compensation. (3) Non-GAAP adjusted basic net income (loss) per share was calculated based on 47,600,505 and 44,814,185 weighted-average shares of common stock outstanding for the three months ended December 31, 2023 and 2022, respectively. (4) Non-GAAP adjusted diluted net income per share was calculated based on 48,040,118 weighted average common shares outstanding and potentially dilutive common stock equivalents (stock options, restricted stock units and warrants) for the three months ended December 31, 2023. (5) Potentially dilutive common stock equivalents (stock options, restricted stock units and warrants) were not included in the non-GAAP adjusted diluted net loss as these shares would be considered anti-dilutive. (6) Non-GAAP adjusted basic net income per share was calculated based on 47,134,331 and 44,674,501 weighted-average shares of common stock outstanding for the years ended December 31, 2023 and 2022, respectively. (7) Non-GAAP adjusted diluted net income per share was calculated based on 47,550,852 and 44,929,998 weighted average common shares outstanding and potentially dilutive common stock equivalents (stock options, restricted stock units and warrants) for the years ended December 31, 2023 and 2022, respectively.