Pharming Group Nv · EURONEXT:PHARM
Pharming Group Nv — Shareholder Meeting (May 2013)
16 slides from Pharming Group Nv's shareholder meeting presentation, May 15, 2013
Slide 1: Pharming Group NV Annual General Meeting
Pharming Group NV (NYSE Euronext: PHARM) Sijmen de Vries, MD, MBA Chief Executive Officer Annual General Meeting of Shareholders Leiden, 15 May 2013 1
Slide 2: Safe harbour statement
Safe harbour statement The information contained in this document and made verbally to you (together the "Presentation") is being supplied to you solely for your information and may not be copied, reproduced or further distributed to any person or published, in whole or in part, for any purpose. The
Slide 3: Operations 2012
Operations 2012 • Validation and production runs completed and certification process initiated with EMA for 2nd downstream production facility at Sanofi- Chimie – Up- scaling of production capacity and reduction in cost of goods – Process and facility approved by EMA in March 2013 • Significant down
Slide 4: Ruconest commercialisation 2012
Ruconest commercialisation 2012 • EU rollout continuing – Challenging EU market access conditions (FY2012 sales € 0.9 M) – Reimbursement discussions at national, regional and local levels ongoing (Italy, Spain) – Sobi recently re- aligned resources to rapidly adapt to leverage reimbursement approval
Slide 5: Financials 2012
Financials 2012 30 25 20 15 2011 10 2012 5 0 Revenues* Operating Net Loss Cash Cash at YE** costs (cont'nd ops) outflows * Includes €7.9M SNTS milestone payment ** ”Pro-forma” YE 2012, includes €16.35M January 2013 CB financing 5
Slide 6: Dutch Corporate Governance Code
Dutch Corporate Governance Code • Corporate Governance Statement 2013 on website www.pharming.com/corporate • Pharming complies with the Dutch Corporate Govenance Code except for sections: (unchanged vs. 2011) – II.2.4. (Options for the management board) – III.3.1. (Profile of the Board of Superviso
Slide 7: Perspectives for 2013 and beyond
Perspectives for 2013 and beyond • BLA Ruconest® for acute HAE sumitted 17 April 2013. – Standard 12 month (PDUFA V) review – Rapidly expanding US acute market segment at US$ 156M + per annum – Differentiated competitive profile in US market; potential for treatment paradigm shift – Significant pote
Slide 8: U.S. Market opportunity
U.S. Market opportunity PHARMING
Slide 9: US market dynamics: growing demand
US market dynamics: growing demand • HAE disease awareness in the US continues to improve, leading to more patient identification* • FY 2012 sales increased from US$ 56M to US$ 156M (acute HAE segment) (179% growth) (Berinert® sales not disclosed***) • US$ 116M Firazyr® (US$ 33M; 2011)** • US$ 40M K
Slide 10: U.S. Competitor profiles
U.S. Competitor profiles recombinant bradykinin receptor kallikrein plasma derived C1 Inhibitor C1 Inhibitor antagonist inhibitor Ruconest Cinryze Berinert Firazyr** Kalbitor Efficacy Excellent Good Good Good Good Dosing (C1INH) 50 U/kg* ~ 12 U/kg 20 U/kg Type of attack Any Any Limited Any Any Respo
Slide 11: Ruconest: potential to be best in class
Ruconest: potential to be best in class • C1 esterase inhibition is Gold Standard for HAE treatment (protein replacement) • Best-in-class efficacy and cleanest safety profile (confirmed in Study 1310) – Absence of thrombo- embolic complications, no anaphylactic reactions • Ability to administer high
Slide 12: Technology Platform
Technology Platform PHARMING
Slide 13: Validated transgenic rabbit (milk) platform
Validated transgenic rabbit (milk) platform High yields drive Value creation by Relevant for most potential for low cost of partnerships therapeutic proteins manufacturing Low set up cost, low risk up-scaling, low cost Complex proteins of intermediate bulk high quality with (frozen milk) holding rel
Slide 14: Successful expression of recombinant human proteins in milk of transgenic animals
Successful expression of recombinant human proteins in milk of transgenic animals achieved by Pharming and others • Serpins: C1 Inhibitor, α1-antitrypsin and Antithrombin-III Plasma Proteins • Clotting Factors VII, VIII, IX and von Willebrand Factor • Albumin and Fibrinogen Metabolic enzymes • α–Glu
Slide 15: Outlook 2013 and beyond
Outlook 2013 and beyond • Ruconest BLA submitted to US FDA (April 2013) • Acceptance for review by FDA triggers US$5M milestone • First US commercial sale triggers US$20M milestone • Proceeds from US commercialisation by SNTS • 30%- 40% of Ruconest net sales • Up to US$45 million in sales related mi
Slide 16: www.pharming.com
www.pharming.com NYSE Euronext: PHARM 16