Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2018)
39 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 21, 2018
Slide 1: Foundation for Growth 2021: A predisposition to long-termism
For personal use only FOUNDATION FOR GROWTH 2021 A predisposition to long-termism CLINUVEL PHARMACEUTICALS LTD ASX: CUV Annual General Meeting Nasdaq Int’l: CLVLY 21 November 2018 Xetra-Dax: UR9 Melbourne
Slide 2: Safe harbour statement
Safe harbour statement 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 or achievements to d
Slide 3: Sections
Sections For personal use only 1 Financial Management 4 Growth 2020 2 EU & US Update 5 3 Pipeline CUV Conclusions
Slide 4: Financial management
For personal use only 1 Financial management
Slide 5: Financials I
Financials I For personal use only $30.00 79% CAGR $20.00 87% $10.00 59% A$M 29% $- -$10.00 -$20.00 FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 Total expenses Total Revenue CUV continues quarterly reporting Cash flow statement will reflect seasonal fluctuations due to cycli
Slide 6: Financials I
Financials I For personal use only $30.00 79% CAGR $20.00 FPOP 87% $10.00 59% A$M 29% $- -$10.00 -$20.00 FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 Total expenses Total Revenue Net cash provided by/(used in) operating activities CUV continues quarterly reporting Cash flow
Slide 7: Financials I
PRE-REVENUE 2005-2016 POST-REVENUE 2016 ONWARDS Financials I - cost-management - cost-management For personal use only - share capital - cash positivity - financial proof of principle - profitability - minimum cash reserves - growth $30.00 60 $20.00 40 EPS A$ cents $10.00 20 A$M $- 0 -$10.00 -20 -$2
Slide 8: Financials II
Financials II For personal use only 2010 2015 2018 Ownership by region Australia Asia-pacific EU/Switzerland North America
Slide 9: EU & US Update
For personal use only 2 EU & US Update
Slide 10: EU distribution
EU distribution For personal use only SCENESSE® approved for adult patients with EPP in 2014, first post-MA use June 2016 Brexit, 29 March 2019 Transfer of marketing authorisation SCENESSE® Reimbursement Alternative effective therapy1 None PASS 100% prescriber continuation (CY2016-2018) Listing pric
Slide 11: SCENESSE featured internationally in 2018
SCENESSE® featured internationally For personal use only in 2018
Slide 12: US regulatory progress
US regulatory progress For personal use only Rejection IND CUV039 completion First NDA modules (Epitan Ltd) under rolling review - critique and GMP inspection FDA ad-hoc meeting concerns ODD for EPP Ph III CUV039 EMA (FDA) EPP patients & families - FDA Q&As Validation 2004 2008 2011 2013 2015 2017 S
Slide 13: Risk-balance assessment SCENESSE
Risk‐balance assessment SCENESSE® For personal use only RISK VS BENEFIT SYSTEMIC PHOTOPROTECTION New Molecular Entity (NME) Novel mode of action Emphasis on safety
Slide 14: Risk-balance assessment SCENESSE
Risk‐balance assessment SCENESSE® For personal use only RISK VS BENEFIT RISK ‐ SAFETY Known risks of NME (afamelanotide): SYSTEMIC PHOTOPROTECTION - during clinical trials - Real World Experience (RWE) = EU PASS New Molecular Entity (NME) Most frequent ADRs: nausea-flushing-gastrointestinal- injecti
Slide 15: Risk-balance assessment SCENESSE
Risk‐balance assessment SCENESSE® For personal use only RISK VS BENEFIT RISK ‐ SAFETY Known risks of NME (afamelanotide): SYSTEMIC PHOTOPROTECTION - during clinical trials - Real World Experience (RWE) = EU PASS New Molecular Entity (NME) Most frequent ADRs: nausea-flushing-gastrointestinal- injecti
Slide 16: Prof E Minder: Clinical experience in EPP 2005-2018
For personal use only Prof E Minder – Triemli Hospital Zürich: Clinical experience in EPP 2005‐2018
Slide 17: Long-term observation on the treatment of EPP patients with SCENESSE
Long‐term observation (up to 12 years) on the For personal use only treatment of EPP patients with SCENESSE Signs of effectiveness under routine clinical condition: 1. Triemli Hospital experience with 1,384 implant administrations 2. High adherence rate >90% 2. Patients permanently acknowledge life
Slide 18: Long-term observation: adverse effects
Long‐term observation on the treatment of EPP For personal use only patients with SCENESSE Adverse effects: • 1 day nausea (0.5-3) immediately after implantation in 10-20% of applications, mild, no treatment required. Most frequently observed after first dose, frequency decreases with following dos
Slide 19: Benefit/risk judgement
Long‐term observation on the treatment of EPP For personal use only patients with SCENESSE Benefit/risk judgement: Patients: “treatment worthwhile, adverse effects minor with respect to effectiveness of treatment” Medical judgment and observations: • change in behaviour, more self esteem (adolescen
Slide 20: Pipeline CUV
For personal use only 3 Pipeline CUV
Slide 21: Pipeline
Pipeline For personal use only Pre‐ Programme – SCENESSE® (afamelanotide 16mg) clinical Phase I Phase II Phase III Approved SCENESSE® in adult EPP patients (Europe) SCENESSE® in adult EPP patients (USA) SCENESSE® in adult EPP patients (Australia, Japan) SCENESSE® in adult vitiligo patients (global)
Slide 22: SCENESSE in vitiligo
SCENESSE® in vitiligo For personal use only FACTS EFFECTIVENESS MODE OF ACTION CUV103 analyses in progress • prevalence ~1%¹ CUV102 [2013] Hypothesis 1 ‐ addressable market 20‐30% ‐ extent or repigmentation • expression VASI (p<0.025) SCENESSE® + NB‐UVB ‐ generalised vs non‐segmental ‐ face: time to
Slide 23: Growth CUV
For personal use only 4 Growth CUV
Slide 24: SCENESSE NME world's first systemic photoprotective
SCENESSE® NME world’s first systemic photoprotective For personal use only - Human volunteers: melanogenesis, reduction in apoptotic epidermal cells EPP - EPP: reduction in phototoxicity VP reduction in anxiety, increased freedom EFFECTIVENESS - Solar Urticaria: reduction in wheal formation - AK/SCC
Slide 25: SCENESSE NME world's first systemic photoprotective
SCENESSE® NME world’s first systemic photoprotective For personal use only - Human volunteers: melanogenesis - reduction in apoptotic epidermal cells EPP - EPP: reduction in phototoxicity VP reduction in anxiety, increased freedom EFFECTIVENESS - Solar Urticaria: reduction in wheal formation - AK/SC
Slide 26: SCENESSE NME world's first systemic photoprotective
SCENESSE® NME world’s first systemic photoprotective For personal use only - Human volunteers: melanogenesis - reduction in apoptotic epidermal cells EPP - EPP: reduction in phototoxicity VP reduction in anxiety, increased freedom EFFECTIVENESS - Solar Urticaria: reduction in wheal formation - AK/SC
Slide 27: Conclusions
For personal use only 5 Conclusions
Slide 28: Conclusions & thank you to CUV team & Board
Conclusions & thank you to CUV team & Board For personal use only FY14-18 CAGR 79% FY18 first dividend to shareholders of >15 years increase in patients, prescribers of SCENESSE® >94% treatment continuation (3 years) CY18 EU PASS: no safety signals from SCENESSE® CY18 vitiligo results CUV103 pending
Slide 29: Patient testimonies – PASS Disease Registry
Patient testimonies – PASS Disease Registry For personal use only “With SCENESSE® my life has become so positive! I am now capable of doing the every day stuff (driving my car, outings, meeting friends and family, cleaning the windows, gardening, basically enjoying myself) without having to think ab
Slide 30: CEO's presentation to the Annual General Meeting
Company Announcement ASX: CUV Nasdaq International Designation: CLVLY XETRA-DAX: UR9 For personal use only CEO’s presentation to the Annual General Meeting Melbourne, Australia 21 November 2018 GOOD MORNING LADIES, GENTLEMEN, MEMBERS OF CLINUVEL, And welcome to Melbourne. It is exciting to see new s
Slide 31: Financials I (transcript)
FINANCIALS I As you can see from the bar chart, CLINUVEL enjoyed significant growth in revenues over the past three financial years due to the increase in demand for SCENESSE® both within the European Union and Switzerland.1 Our compounded annual growth rate has been 59%, 87% and 79% over the past t
Slide 32: For personal use only
Importantly, we see cash in hand serving as a cyclical capital buffer during economic retreat, market corrections, or unexpected operational set-backs. Although CLINUVEL is not providing financial guidance at this stage given ongoing and incomplete discussions on reimbursement in Europe, management
Slide 33: For personal use only
Significant in 2019 will be the first reduction and relaxation of reporting obligations under the post-authorisation commitments as agreed with the European Medicines Agency (EMA). Instead of safety analyses being performed every six months to populate periodic safety update reports (PSURs), CLINUVE
Slide 34: For personal use only
Our regulatory team are now awaiting reactions from the FDA on CLINUVEL’s latest responses on product and manufacturing. Due to strict confidentiality between sponsor and FDA, nothing further may be disclosed at this time. Logically, the next steps would ordinarily be the formal conclusion of the va
Slide 35: For personal use only
Only two factors can allay concerns or fears and convince regulators: time and consistency. A change in strategy would jeopardise all the work and credibility our teams have established for such a long time; CLINUVEL cannot allow this to occur now or in the future. On the benefit side, the EPP trial
Slide 36: For personal use only
Without censure or editing, Professor Minder will speak about her experiences with SCENESSE® in EPP. In accordance to it policy, CLINUVEL does not induce reimburse or pay Professor Minder or any other physician and aims to keep prescribers independent for them to take decisions without bias. Profess
Slide 37: For personal use only
For a long time we have held a scientific focus serving the medical population and pursued the commercial ambition to grow the Company. But to realise these ambitions, we needed to start systemically and work our way downstream. We gained the understanding of how linear molecules of the melanocortin
Slide 38: For personal use only
In choosing to manage this asset class, we seek a commonality between stakeholders while we recognise that there are different perspectives and interests. Most of you present today share that you invest or remain invested in CLINUVEL because the equity provides direct benefit to patients and their c
Slide 39: For personal use only
reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; any failur
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