Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Sachs 18th Annual Biotech in Europe Forum 2018
13 slides from Clinuvel Pharmaceuticals's conference presentation, Oct 8, 2018
Slide 1: Sachs 18th Biotech in Europe Forum Presentation
Company Announcement SACHS 18TH BIOTECH IN EUROPE FORUM PRESENTATION Melbourne, Australia, 08 October 2018 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) presented at the Sachs 18th Biotech in Europe Forum on Thursday 04 October. A copy of the presen
Slide 2: and knowhow for further development of its product candidates or may not reach favourable
and knowhow for further development of its product candidates or may not reach favourable agreements with potential pricing and reimbursement agencies in Europe and the US; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE® which may lead to it being unable to
Slide 3: CLINUVEL Pharmaceuticals Ltd - 18th Annual Biotech in Europe Forum
CLINUVEL PHARMACEUTICALS LTD 18th Annual Biotech in Europe Forum Basel, 4th October 2018 Daniela Schaefer ASX: CUV VP Global Business Development NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY XETRA: UR9
Slide 4: Forward-looking statements, "safe harbor"
Forward-looking statements, “safe harbor” 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 or achievements to diff
Slide 5: Business Overview
Business Overview • 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 responsibility to trea
Slide 6: CLINUVEL's business focus - systemic photoprotection
CLINUVEL’s business focus - systemic photoprotection • Genetic metabolic disorder(s) • 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 benchmark • Afamelanotide 16
Slide 7: SCENESSE - medical innovation/breakthrough
SCENESSE® - medical innovation/breakthrough FLOW OF KNOWHOW ON MELANOCORTINS 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 registry 2nd indication Q4’
Slide 8: CLINUVEL's European operations
How does CLINUVEL commercialize its technology? CLINUVEL’s European operations Special Access Schemes since 2010 SCENESSE® commercially distributed since 2016 Direct, controlled EU distribution to EPP expert centres EMA risk management plan, global disease registry, “PASS” Results to date 66.1% incr
Slide 9: US FDA timeline 2019-20
US FDA timeline 2019-20 NDA OUTCOME / 2018 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 CUV039 2008 APPROVAL P
Slide 10: Financials I CLINUVEL's DNA
Financials I CLINUVEL’s DNA • 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® 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: Conclusions CLINUVEL
Conclusions CLINUVEL POC PRECLIN PI PII PIII COMMERCIAL • 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 • SCENESSE® awaiting PDUFA d
Slide 13: Q&A 18th Annual Biotech in Europe Forum
Q&A 18th Annual Biotech in Europe Forum Basel, 4th October 2018 Daniela Schaefer ASX: CUV VP Global Business Development NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY XETRA: UR9
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