Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Investor Presentation (December 2014)
24 slides from Clinuvel Pharmaceuticals's investor presentation, Dec 4, 2014
Slide 1: A specialty pharmaceutical in dermatology
For personal use only A specialty pharmaceutical in dermatology Mr Stan McLiesh, Chair ASX: CUV Dr Philippe Wolgen, CEO XETRA‐DAX: UR9 Mr Darren Keamy, CFO ADR: CLVLY DECEMBER 2014
Slide 2: Forward-looking statements
This release contains forward‐looking statements, which reflect the current beliefs and For personal use only 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 differ significantly fro
Slide 3: Concept and label extensions
CONCEPT For personal use only EPP Orphan drug LABEL EXTENSIONS EU marketing authorisation Proof of Concept √ EPP PAEDIATRIC Reimbursement 2010‐2014 √ Key markets: EU‐CH‐US‐Japan VITILIGO Larger market Key markets: US‐ASIA‐STH AFRICA Systemic COMPLEMENTARY TREATMENT Rx Topical
Slide 4: Funding rounds, share price and trading volumes
FUNDING ROUNDS JAN ‘06 – MAY ‘14 9 Rounds HISTORICAL SHARE PRICE ASX: CUV Equity $86.9M For personal use only $40 Cash on hand $12.5M 09/30 $14.00 Nov‐06 $35 $35.2m Ave Monthly Burn ‘12‐’14 $731k $12.00 Share price $A Apr‐07 $30 DEBT FREE Funds Raised A$m $10.00 $26m $25 $8.00 $20 Dec‐05 $6.00 $15 $
Slide 5: Shareholder and geographic breakdown
For personal use only Institutions & Custodians Retail & Other 32.3% 29.5% Asia‐Pacific 40.79% North America 29.21% EU/Switzerland 30.00% ADRs 9.8% Related Sophisticated parties 4.6% Investors & Brokers 23.8%
Slide 6: Expenses per indication
For personal use only Expenses per indication Clin. Dev. Expenses: A$24.0m Formulation: A$23.4m Vitiligo, 8% Regulatory: A$6.6m Others Ph1, 37% Marketing & Listing: A$7.8m Patents & Trademarks: A$4.7m EPP, 55% Operations: A$41.8m Total Expenses: A$108.3m
Slide 7: Budgeted expenditure
For personal use only A$ m Clinical development 3.5 Drug delivery, formulation 3.3 Regulatory Affairs 1.3 Personnel 10.0 Overheads, Marketing & Corporate 5.9 Total ** 23.9 * Expenditures foreseen subject to corporate progress ** excludes receipts, interest & R&D incentives
Slide 8: Convergence in knowledge in days of review
CONVERGENCE IN KNOWLEDGE IN 947 DAYS OF REVIEW For personal use only QUALITY OUTSET OUTCOME Drug substance – manufacture/quality control Drug product – manufacture/quality control NONCLINICAL Pharmacology Toxicology CLINICAL Pharmacology – mode of action Clini
Slide 9: EPP clinical trials
n 1st EP 2nd EP For personal use only CUV010 5 pain, tolerance to λ melanin p 0.0069 density CUV017 100 pain tolerance to 2010 AIFA 648/96 p 0.0023/0.0017 λ CUV030 77 exposure to λ pain, QoL p 0.036/0.025 2011 SWISSMEDIC CUV029 74 exposure to λ pain, QoL p 0.005 CUV039 93 exposure to λ QoL p 0.107 2
Slide 10: Melanocortin peptide properties
For personal use only 1 2 3 4 5 6 7 8 9 10 11 12 13 Ac Ser Tyr Ser Nle Glu His Dphe Arg Trp Gly Lys Pro Val NH2 • Theoretical properties of melanocortins: 1. melanogenic 2 anti‐inflammatory 3 anti‐carcinogenic • Human pharmacology, bioresponse and safety determine commercial value
Slide 11: Impact of EPP on patients
For personal use only • Light deprivation/starvation since childhood • Social isolation affecting childhood development • Impact professional options • Mood affective disorders • ‘Pain’ is non‐responsive to analgesics “This summer I have had to deal with pain daily and I can’t afford to take time of
Slide 12: Market research on SCENESSE for EPP
STAGE I MARKET RESEARCH ON SCENESSE® FOR THE PREVENTION OF EPP For personal use only SEVERITY Cerebrovascular Accident Acute Lymphoblastic Leukemia MS Prostate Hemophilia Myocardial Cancer Infarction EPP Crohn’s/UC Acute Macular Chronic Lumbar Pain Degeneration Refractive HNP Lymph Edema Diabetic Ac
Slide 13: Reimbursement prior to EMA approval
REIMBURSEMENT OF SCENESSE® PRIOR TO EMA APPROVAL SAS* For personal use only SAS 2010 2011 2012 2013 2014 ITA 1 1 1 1 4 CH n/a n/a 12 14 14 EU ‐ other 0 0 1 3 6 TOTAL 1 1 14 18 24 PREVALENCE EPP 1:140,000 CONTINUATION AFTER TRIAL 94% DISCONTINUATION AFTER 5 YEARS OF SPECIAL ACCESS 22.6% SCHEMES COST
Slide 14: Vitiligo path to commercialisation
For personal use only • FDA acknowledges rationale of proposed treatment SCENESSE® • 10% body involvement • Dark skin complexion Fitzpatrick IV‐VI • 3 trials, 2 pivotal comb. NB‐UVB‐ SCENESSE® n 600 • US first market of entry, MEA* & Asian markets second • Global prevalence 1‐2% of global population
Slide 15: Vitiligo repigmentation images
For personal use only Day 0 Day 27 Day 55 Day 111 Day 176 Baseline After 9 NB‐UVB After 15 NB‐UVB After 27 NB‐UVB After 40 NB‐UVB treatments treatments, 1 implant treatments, 3 implants treatments, 4 implants • Images are as originally supplied by the clinical center and ID numbers have been removed
Slide 16: Follicular repigmentation images
For personal use only Enlarged image of left thigh showing generalised follicular repigmentation Day 0 Day 55 Day 176 Baseline After 15 NB‐UVB After 40 NB‐UVB treatments, 1 treatments, 4 implant dose implant doses • Images are as originally supplied by the clinical center and ID numbers have been re
Slide 17: Follicular repigmentation - Vitiligo (CUV102)
eee FOLLICULAR REPIGMENTATION - VITILIGO (CUV102)
Slide 18: Follicular repigmentation - Vitiligo (CUV102)
FOLLICULAR REPIGMENTATION - VITILIGO (CUV102)
Slide 19: Summary
SUMMARY EMA approval validated SCENESSE® and melanocortins SCENESSE® healtheconomic impact being assessed Clinuvel prepares for distribution in 2015 EPP impacts vitiligo development
Slide 20: A specialty pharmaceutical in dermatology
For personal use only A specialty pharmaceutical in dermatology Mr Stan McLiesh, Chair ASX: CUV Dr Philippe Wolgen, CEO XETRA‐DAX: UR9 Mr Darren Keamy, CFO ADR: CLVLY DECEMBER 2014
Slide 21: Presentation speaking notes
Investor update presentation speaking notes Melbourne, Australia and Zug, Switzerland, December 4, 2014 For personal use only Slide 1: INVESTOR UPDATE This serves as an investor update at the end of the calendar year 2014 summarising a number of corporate events and, most importantly, the EMA approv
Slide 22: Speaking notes: positive CHMP evaluation
Slide 8: POSITIVE CHMP EVALUATION 23 OCTOBER 2014 The introduction of novel SCENESSE® (afamelanotide 16mg) met much regulatory resistance at the beginning of the review process, as seen in the left column of the balance score card. It could have been expected from any pharmaceutical company to withd
Slide 23: Speaking notes: European distribution
Slide 13: EUROPEAN DISTRIBUTION SCENESSE® Data collected over the years from compassionate use programs and special access schemes provide fertile ground for understanding marketing and sales throughout the European Union. Distribution through the special access schemes in Italy and Switzerland are
Slide 24: About Clinuvel Pharmaceuticals Limited
Slide 19: SUMMARY No notes. ‐ End ‐ About Clinuvel Pharmaceuticals Limited Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA‐DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in For per
Clinuvel Pharmaceuticals — Investor Presentation (December 2014) on 6ix