Pharming Group Nv · EURONEXT:PHARM
Pharming Group Nv — Shareholder Meeting (June 2014)
18 slides from Pharming Group Nv's shareholder meeting presentation, Jun 18, 2014
Slide 1: Pharming Group NV Annual General Meeting of Shareholders
Pharming Group NV (NYSE Euronext: PHARM) Sijmen de Vries, MD, MBA Chief Execu?ve Officer Annual General Meeting of Shareholders Leiden, 18 June 2014. 1
Slide 2: Safe harbour statement
Safe harbour statement The informa,on contained in this document and made verbally to you (together the "Presenta,on") is being supplied to you solely for your informa,on and may not be copied, reproduced or further distributed to any person or published, in whole or in part, for any purpose. The Pr
Slide 3: Contents
Contents • Opera9ons 2013 • Corporate Social Responsibility and sustainability • Financial headlines 2013 • Dutch Corporate Governance • Risk Management & Controls • Business Model • Technology PlaQorm and SIPI collabora9on • Outlook 2014 and beyond 3
Slide 4: Operations 2013
Opera?ons 2013 • Cer?fica?on by EMA for 2nd downstream produc?on facility at Sanofi-‐ Chimie – Up-‐ scaling of produc9on capacity and reduc9on in cost of goods – Manufacturing of inventories for US launch was ini9ated 2H2013 • Restructuring of organisa?on completed, in addi?on significant savings ach
Slide 5: Operations 2013
Opera?ons 2013 • EU rollout con?nuing by partner Sobi – Improving in-‐ market sales under challenging EU market access condi9ons • FY2013 revenues from sales to Sobi at €0.9M – Significant market penetra9on in several Central/ Eastern European markets – Consistent and significant repeat use and high
Slide 6: Corporate Social responsibility/ sustainability
Corporate Social responsibility/ sustainability • Medical need and pa?ent safety • Code of Conduct • Animal care code of conduct and animal welfare • Environmental impact of opera?ons and trace-‐ ability of supply chain • Diversity and equal opportuni?es 6
Slide 7: Financial headlines: Revenues 2013
Financial headlines: Revenues 2013 8 7 6 5 4 2012 3 2013 2 1 0 Grants Revenues from Deferred Milestones sales revenues 7
Slide 8: Financial headlines 2013
Financial headlines 2013 30 25 20 15 2012 10 2013 5 0 Total Opera9ng Net Loss Cash Cash at YE revenues* costs (cont'nd ops) ouQlows *Including SNTS milestone payments (2012 $10 million/ 2013 $5 million) 8
Slide 9: Dutch Corporate Governance Code
Dutch Corporate Governance Code Corporate Governance Statement 2014 on website www.pharming.com/corporate Pharming complies with the Dutch Corporate Governance Code except for sec?ons: II.2.4. (Op?ons for the Management board) II.2.6. (Op?on exercise price) III.3.1. (Profile of the Board of Superviso
Slide 10: Risk management and controls
Risk management and controls • Periodical risk assessments and reviews – Types of risk assessed (in no par9cular order) – Macro (economical), Clinical and Regulatory, Research, Manufacturing, Commercial, Financial, IT, Human Resources • Financial control systems – All revenues are generated and cont
Slide 11: Business model
Business model • Future profitability ini9ally driven by • Proceeds from Ruconest US sales – Tiered supply price to SLXP: 30-‐ 40% of net sales • Proceeds from Ruconest EU sales – Fixed supply price per vial to Sobi • Poten9al for increases of profitability/ vial as results of – Economies of scale in
Slide 12: US market: Rapid growth, significant potential
US market: Rapid growth, significant poten?al • HAE disease awareness in the US con?nues to improve, leading to more pa?ent iden?fica?on* • FY 2013 sales for acute treatment increased to approx. US$ 275M from US$ 156M for FY2012 (50% growth) excluding Berinert® sales (not disclosed***) • US$ 235M Fira
Slide 13: HAE treatment options (published data)
HAE treatment op?ons (published data) recombinant C1 bradykinin receptor plasma derived C1 Inhibitor kallikrein inhibitor Inhibitor antagonist Ruconest^ Cinryze^^ Berinert Firazyr** Kalbitor^^^ Efficacy Excellent Good Good Good Good Dosing (C1INH) 50 U/kg* ~ 12 U/kg 20 U/kg Treatment type Any acute Pr
Slide 14: Technology Platform
Technology Platform PHARMING
Slide 15: Strategic product development collaboration
Strategic product development collabora?on SIPI (Shanghai Ins?tute for Pharmaceu?cal Industry: A Sinopharm company) • Product development at SIPI – Under Pharming’s fully ICH compliant QA systems – Compliant with CFDA, FDA and EMA standards – Funded by SIPI up to IND – Aligned clinical development (
Slide 16: SIPI collaboration
SIPI collabora?on • Commercialisa?on rights: SIPI China/ Pharming ROW – Reciprocal royal9es at 4%: SIPI (China)/ Pharming (ROW) – SIPI to pay product related milestones for all future products developed – SIPI to supply Pharming on “cost plus” basis for ROW • SIPI pays €1.26 million upfront and € 0.
Slide 17: Outlook 2014 and beyond
Outlook 2014 and beyond • PDUFA date Ruconest® for acute HAE 16 July 2014. – Differen9ated compe99ve profile/ Rapidly expanding US acute market segment es9mated at >US$ 400M + per annum – Significant poten9al near term milestone US$ 20M (first US commercial sale) – Revenues from US net sales between 30-
Slide 18: www.pharming.com
www.pharming.com NYSE Euronext: PHARM 18