Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Nasdaq Virtual Investor Conference 2018
15 slides from Clinuvel Pharmaceuticals's conference presentation, Sep 20, 2018
Slide 1: Nasdaq International Designation Virtual Investor Conference Presentation
Company Announcement NASDAQ INTERNATIONAL DESIGNATION VIRTUAL INVESTOR CONFERENCE PRESENTATION For personal use only Melbourne, Australia, and New York, USA, 20 September 2018 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) presented to the Nasdaq Vir
Slide 2: Forward-Looking Statements
assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the FDA may require additional studies beyond th
Slide 3: CLINUVEL Pharmaceuticals Ltd - Nasdaq Virtual Investor Conference
For personal use only CLINUVEL PHARMACEUTICALS LTD Nasdaq Virtual Investor Conference New York, 19 September 2018 Philippe Wolgen ASX: CUV Chief Executive Officer NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY XETRA: UR9 Continuum Health Communications tclevenger@continuumhealthcom.com
Slide 4: Forward-looking statements, safe harbor
Forward-looking statements, “safe harbor” For personal use only This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Statements may involve a number of known and unknown risks that could cause our future results, performance o
Slide 5: Business Overview
Business Overview For personal use only • Specialty pharmaceutical company • Longevity (14 years) – Management and Board • No alternative treatment to SCENESSE® (afamelanotide 16mg), no competition • EU [EMA] approved product, awaiting PDUFA date [FDA] for orphan indication porphyria (EPP) • Social
Slide 6: CLINUVEL's business focus - systemic photoprotection
CLINUVEL’s business focus - systemic photoprotection • Genetic metabolic disorder(s) For personal use only • Intolerant to light emission (blue-green/UVB/UVA) Phototoxic reaction in an EPP patient. • High unmet medical need(s) Image courtesy of the Koerner family. • No alternative therapy, no benchm
Slide 7: SCENESSE - medical innovation/breakthrough
SCENESSE® - medical innovation/breakthrough FLOW OF KNOWHOW ON MELANOCORTINS For personal use only Proof of concept - porphyrias (EPP) 1991- 2018 EPP • Systemic protection, visible light (>408nm) • 34 clin. trials >975 patients • Rare disorder 1:140,000 • >7,900 afamelanotide doses • Global disease
Slide 8: How does CLINUVEL commercialize its technology?
How does CLINUVEL commercialize its technology? CLINUVEL’s European operations Special Access Schemes since 2010 SCENESSE® commercially distributed since 2016 For personal use only Direct, controlled EU distribution to EPP expert centres EMA risk management plan, global disease registry, “PASS” Resu
Slide 9: US FDA timeline 2019-20
US FDA timeline 2019-20 NDA OUTCOME / 2018 For personal use only RISK-BENEFIT 2016 NDA FILING, “ROLLING REVIEW” 2016 PRE-NDA MEETING 2016 PILOT 1ST FDA WORKSHOP ON EPP 2016 FAST TRACK DESIGNATION 2013 CLINICAL DATA PACKAGE AGREED FOR SUBMISSION 2011 POSITIVE PHIII RESULTS CUV039 2010 APPROVAL PHIII
Slide 10: Financials I - CLINUVEL's DNA
Financials I CLINUVEL’s DNA For personal use only • Disciplined financial management 2005-2018 • Debt-free • Expertise in house Quarterly Operating Cash Outflows $5 $4 $3 A$m $2 $1 $0 Q1 05 Q1 06 Q1 07 Q1 08 Q1 09 Q1 10 Q1 11 Q1 12 Q1 13 Q1 14 Q1 15 Q1 16 Q1 17 Q1 18
Slide 11: Financials II P&L - medical innovation SCENESSE
Financials II P&L – medical innovation SCENESSE® For personal use only Total funds committed to SCENESSE® program to date: A$172m Industry standard development costs US$600-800m Profit after tax (FY18) A$13.224m Unfranked dividend per ordinary share (FY18) $A0.02
Slide 12: Financials III
Financials III ASX: CUV – 12 months For personal use only $19.00 $17.00 Shares on issue: 47,857,986 Ave daily trading volume (3 months) 60,225 $15.00 $13.00 $11.00 $9.00 $7.00 $5.00 15 Sep 17 15 Nov 17 15 Jan 18 15 Mar 18 15 May 18 15 Jul 18 15 Sep 18
Slide 13: CLINUVEL Group ownership
CLINUVEL Group ownership ASX: CUV XETRA-DAX: UR9 For personal use only ADR: CLVLY (Nasdaq International Designation) Market Cap (17 September) A$873.9m 52 week high-low A$6.40-$18.89 Rest of World/Unanalyzed Board, management and staff 8.87% 12.7% Asia Australia Lagoda Investment Management 7.12% 8.
Slide 14: Conclusions
Conclusions CLINUVEL POC PRECLIN PI PII PIII COMMERCIAL For personal use only • Specialty pharmaceutical company • Longevity Management and Board ((14 years) SCENESSE® in EUROPE [EPP] • No alternative treatment to SCENESSE® SCENESSE® in USA [EPP] • SCENESSE® commercially distributed in Europe • SCEN
Slide 15: Q&A Nasdaq Virtual Investor Conference
Q&A Nasdaq Virtual Investor Conference For personal use only New York, 19 September 2018 Philippe Wolgen ASX: CUV Chief Executive Officer NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY XETRA: UR9 Continuum Health Communications tclevenger@continuumhealthcom.com
CLINUVEL Pharmaceuticals — Nasdaq Virtual Investor Conference 2018 on 6ix