Spotlight on Drug Pipeline: 2019 and Beyond Michele Yoon, Pharm.D. 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 1 Ventegra Overview Formed in 2004 “Veritas” (Truth) + “Integritas” (Integrity) Company of Healthcare Professionals! A family-owned California Corporation Based in Glendale, CA Certified Small Business Certified B-Corp. (by B-Lab) Certified Member of MSDC Ventegra, Inc., a California Benefit Corporation Servicing 107 Clients; 9,805,193 lives (4Q 2015) Being recognized as a “new Class of Trade” 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 2 1 Overview • Key trends • Pipeline targets most impactful to physician groups • Specialty drugs • Significant pipeline therapeutic areas • Management strategies 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 3 Market Trends 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 4 2 2018 FDA approvals: All-time Record • 61 new molecular entities approved • 1996 was previous record @ 50 https://www.forbes.com/sites/bernardmunos/2019/01/14/2018-new-drugs-approvals-an-all-time-record-and-a-watershed/#4fbcb80a332d 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 5 Rare Diseases = 51% of Approvals https://www.forbes.com/sites/bernardmunos/2019/01/14/2018-new-drugs-approvals-an-all-time-record-and-a-watershed/#4fbcb80a332d 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 6 3 Trends https://www.forbes.com/sites/bernardmunos/2019/01/14/2018-new-drugs-approvals-an-all-time-record-and-a-watershed/#4fbcb80a332d 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 7 • An orphan drug is a product intended for the treatment, diagnosis, or prevention of a rare disease. A rare disease also affects fewer than 200,000 people in the United States 2017-2018 Pharmaceutical Marketplace Trends: Douglas Long, V.P. Industry Relations, IQVIA. Market Trends and Pricing 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 8 4 2017-2018 Pharmaceutical Marketplace Trends: Douglas Long, V.P. Industry Relations, IQVIA. Market Trends and Pricing 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 9 Trends 2019 • Specialty drugs will continue to dominate the new drug approvals • Specialty drugs will attribute to approx. 50% of the prescription spend by 2020 • 2024: Orphan drug pipeline will contribute $188bn in sales (35% of combined pipeline forecast) • Increased competition • Some specialty blockbusters are coming to end of their exclusivity • Potential for generic and biosimilar competition • Caner drug development • Orphan drug development • Top therapeutic areas : Blood, CNS and respiratory AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19 www.evaluate.com/orphandrug2019. Accessed 5/9/19 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 10 5 Therapy Classes Impacted by Specialty Significant Disease Impacted by Specialty Drugs Cancer* HIV/AIDS* Crohn’s Disease Immune disorders* Gaucher’s Disease Infertility Growth Hormone Deficiency Multiple Sclerosis* Hemophilia* Pulmonary hypertension Hepatitis C* Rheumatoid Arthritis* *Indicates therapeutic class with maturing products 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 11 Increased Competition AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 12 6 AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 13 Biosimilar* Opportunity *FDA BIOSIMILAR definition: Biologic product that is “highly similar to” an approved biologic product (the “reference,” “originator,” or “bio- originator” product) and that has “no clinically meaningful differences” in safety or effectiveness as compared to the reference product AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 14 7 FDA-Approved Biosimilars Approval Biosimilar Originator Launch Biologic Date 9/23/16 Amjevita – Amgen/Adalimumab-atto Humira® 2023 8/25/17 Cyltezo - Boehringer/Adalimumab-adbm 2023 10/31/18 Hyrimoz – Sandoz/Adalimumab-adaz 2023 9/14/17 Mvasi – Amgen/Allergan/Bevacizumab-awwb Avastin® ? 5/15/18 Retacrit – Pfizer/Epoetin alpha-epbx Procrit®/Epogen® Available 3/6/15 Erelzi – Sandoz/Etanercept-szzs Enbrel® 2019 or 2029 4/26/19 Enticovo – Samsung Bioepis/etanercept-ykro Enbrel® 2019 or 2029 3/6/15 Zarxio – Sandoz/Filgrastim-sndz Neupogen® available 7/23/18 Nivestym – Pfizer/Filgrastim-aafi available 4/5/16 Inflectra – Pfizer/Infliximab-dyyb Remicade® available 4/21/17 Renflexis – Merck/Infliximab-abda available 12/13/17 Ixifi – Pfizer/Infliximab-qbtx Not launching 6/5/18 Fulphila – Mylan/Pegfilgrastim-jmbd Neulasta® Available 11/2/18 Udenyca – Coherus/Pegfilgrastim-cbqv Available 11/28/18 Truxima – Celltrion/rituximab-abbs Rituxan ? 12/1/17 Ogivri - Mylan/trastuzumab-dkst Herceptin TBD 12/18/19 Herzuma – Celltrion/trastuzumab-pkub) 1/18/19 Ontruzant – Samsung/trastuzumab-dttb 3/12/19 Tranzimera – Pfizer/trastuzumab-qyyp 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 15 Biosimilars Pending FDA Approval as of February 2019 Biosimilar Biosimilar applicant Reference Status/Anticipated Approval Manufacturer Adalimumab Samsung Humira® – AbbVie July 2019 (Imraldi™) Bioepis/Merck Adalimumab-ADBM Pfizer Humira® - Abbvie 4Qtr2019 Bevacizumab Pfizer Avastin® - Genentech June 2019 Infliximab Amgen Remicade® – Janssen Oct. 17, 2019 Filgrastim Tanvex BioPharma Neupogen® (Amgen) Aug. 1, 2019 Filgrastim Adello Biologic Neupogen® (Amgen) 2019 - pending Filgrastim Grastoil/Apotex Neupogen® (Amgen) 2019 Pegfilgrastim Sandoz Neulasta® (pegfilgrastim) Oct. 3, 2019 Amgen Pegfilgrastim Apotex/Intas Neulasta® (pegfilgrastim) Pending (Lapelga™) Amgen Rituximab Pfizer Rituxan® (Genentech) July 2019 Trastuzumab Amgen, Allergan Herceptin® (Genentech) June 2019 (kanjinti™) Trastuzumab Pfizer Herceptin® (Genentech) 1Q:2019 (Trazimera™) Teriparatide Pfenex Forteo® (Eli Lilly) Oct. 7, 2019 https://www.jdsupra.com/legalnews/biosimilars-2018-year-in-review-72247/. accessed 2/4/19 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 16 8 Biosimilars Phase 3/Pre-BLA Biosimilar Biosimilar Reference Status/Anticipated Approval applicant Manufacturer Adalimumab Coherus Humira® – AbbVie TBD Adalimumab Fresenius Humira® - Abbvie TBD Adalimumab Kyowa Hakko Kirin Humira® - Abbvie TBD Adalimumab Momenta Humira® - Abbvie TBD Adalimumab Mylan Humira® - Abbvie TBD Aflibercept (CHS- Coherus Eyelea® – Regeneron Phase 3/BLA end of 2019. Abbvie 1420) agreement – launch 2023 Aflibercept (M710) Momenta/Mylan Eyelea® – Regeneron Phase 3 Bevacizumab Samsung Bioepis Avastin® – Genentech Phase 3 Ranibizumab Coherus Lucentis® - Genentech Phase 3 Ranibizumab Samsung Lucentis® - Genentech Phase 3 Ranibizumab Xbrane Lucentis® -Genentech Phase 3 https://www.jdsupra.com/legalnews/biosimilars-2018-year-in-review-72247/. accessed 2/4/19 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 17 Specialty Pipeline: Inflammatory/Immune Conditions Drug Manufacturer MOA Indication Route Approval (PDUFA) Risankizumab Abbvie IL-23 inhibitor Psoriasis SC Q12 wks Approved (Skyrizi®) Upadacitinib Abbvie JAK1 inhibitor RA, Crohn’s, Oral 8/20/2019 Atopic Once daily dermatitis Filgotinib Gilead JAK1 inhibitor RA Oral 2020 Once daily Bimekizumab UCB IL-17A and IL-17F Psoriasis SC Q 4wks 2020 Inhibitor Viaskin Peanut DBV Tech Allergy peanut allergy Patch TBD immunotherapy AR101 Aimmune Immunotherapy Peanut Allergy Oral 2020 https://biopharmcatalyst.com/calendars/fda-calendar. Accessed 3/15/19 AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 18 9 Specialty Pipeline: Multiple Sclerosis Drug Manuf. MOA Indication Route Approval (PDUFA) Cladribine EMD Serono DNA synthesis RMS Oral Approved (Mavenclad®) inhibitor Siponimod Novartis SP1 receptor RMS, SPMS Oral Approved (Mayzent®) Diroximel Biogen/Alkermes NrF2 activator RMS Oral 10/17/19 fumarate (Vumerity™) Ozanimod Celgene SP1 – 1/5 receptors RMS Oral 3/25/20 Monomethyl Banner Life Sciences NrF2 activator RMS Oral 6/20/20 fumarate* RMS = Relapsing multiple sclerosis; SPMS = Secondary progressive multiple sclerosis *Novel fumarate bioequivalent to Tecfidera SIP = Sphingosine-1-phosphate receptor https://biopharmcatalyst.com/calendars/fda-calendar. Accessed 3/15/19 AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 19 Specialty pipeline: Cancer 2019 Drug Manuf. MOA Indication Route Approval (PDUFA) Erdafitinib Janssen Fibroblast growth Urothelial Cancer Oral Approved factor receptor(FGFR) inhibitor Quizartinib Daiichi Sankyo FMS-like tyrosine Acute myeloid Oral 5/25/19 kinase 3 (FTL3) leukemia inhibitor Selinexor Karyopharm Selective inhibitor Penta-refractory Oral 7/6/19 nuclear export (SINE) multiple myeloma after 3 prior txs Pexidartinib Daiichi Sankyo Colony stimulating Tenosynovial giant cell Oral 8/3/19 factor-1 receptor tumor (TGCT) (CSF1R) inhibitor Entrectinib Genentech TrKA, TrKB, TrKC, ROS1, NTRK-fusion+ solid Oral 8/18/19 and ALK inhibitor tumors Polatuzumab Genentech Cytotoxic agent Large B-cell lymphoma IV 8/19/19 vedotin Fedratinib Celgene Selective JAK2 Myelofibrosis Oral 9/3/19 Darolutamide Bayer Prostate cancer Oral