Presentation is loading. Please wait.

Presentation is loading. Please wait.

ADOCIA – CORPORATE PRESENTATION

Similar presentations


Presentation on theme: "ADOCIA – CORPORATE PRESENTATION"— Presentation transcript:

1 ADOCIA – CORPORATE PRESENTATION
Actionaria event – Palais des Congrès Paris, France – November 21-22, 2014

2 Disclaimer November 2014 Property of ADOCIA
This document has been prepared by ADOCIA (the "Company") and is provided for information purposes only. The information and opinions contained in this document are provided as of the date of this document only and may be updated, supplemented, revised, verified or amended, and thus such information may be subject to significant changes. The Company is not under any obligation to update the information or opinions contained herein which are subject to change without prior notice. The information contained in this document has not been subject to independent verification. No representation, warranty or undertaking, express or implied, is made as to the accuracy, completeness or appropriateness of the information and opinions contained in this document. The Company, its subsidiaries, its advisors and representatives accept no responsibility for and shall not be held liable for any loss or damage that may arise from the use of this document or the information or opinions contained herein. This document contains information on the Company’s markets and competitive position, and more specifically, on the size of its markets. This information has been drawn from various sources or from the Company’s own estimates. Investors should not base their investment decision on this information. This document contains certain forward-looking statements. These statements are not guarantees of the Company's future performance. These forward-looking statements relate to the Company's future prospects, developments and marketing strategy and are based on analyses of earnings forecasts and estimates of amounts not yet determinable. Forward-looking statements are subject to a variety of risks and uncertainties as they relate to future events and are dependent on circumstances that may or may not materialize in the future. Forward-looking statements cannot, under any circumstance, be construed as a guarantee of the Company's future performance and the Company’s actual financial position, results and cash flow, as well as the trends in the sector in which the Company operates, may differ materially from those proposed or reflected in the forward-looking statements contained in this document. Even if the Company’s financial position, results, cash-flows and developments in the sector in which the Company operates were to conform to the forward-looking statements contained in this document, such results or developments cannot be construed as a reliable indication of the Company's future results or developments. The Company does not undertake any obligation to update or to confirm projections or estimates made by analysts or to make public any correction to any prospective information in order to reflect an event or circumstance that may occur after the date of this document. This document does not constitute an offer to sell or subscribe or a solicitation to purchase or subscribe for securities in France, the United States or any other jurisdiction. Securities may not be offered or sold in the United States absent registration under the US Securities Act of 1933, as amended, or an exemption from registration thereunder. No public offering of securities will be conducted in France or abroad prior to the delivery by the French Autorité des Marchés Financiers (Financial Markets Authority) of a visa on a prospectus that complies with the provisions of Directive 2003/71/CE as amended. No public offering of securities is contemplated in France or any jurisdiction outside France. The distribution of this document may be restricted by law and persons into whose possession this document comes should inform themselves about, and observe, any such restrictions. November 2014 Property of ADOCIA

3 ADOCIA - Management Gérard Soula Olivier Soula Valérie Danaguezian Rémi Soula President & CEO Deputy General Manager Chief Financial Officer Business Development R&D Director & Intellectual Property Director November 2014 Property of ADOCIA

4 ADOCIA in brief Founded end of 2005 by Gérard, Olivier and Rémi Soula
Listed on Euronext Paris since February 2012 Experienced management and collaborators, including 30 Ph.Ds Cash position of €12.6M at end of September 2014 Platform technologies BioChaperone® platform: a major leap to improve protein performance (insulin, growth factors, mAbs…) DriveIn® platform: nanotechnology for targeted drug delivery in oncology New technologies for mAb formulation 3 therapeutic areas Diabetes: Unique portfolio of 3 insulin products in clinical development Wound healing, Diabetic Foot Ulcer treatment: BioChaperone PDGF-BB Oncology: DriveIn-Doxorubicin and DriveIn-Docetaxel, for the treatment of solid tumors November 2014 Property of ADOCIA

5 ADOCIA A unique excellence center for innovative insulin formulation
ADOCIA is deeply rooted in more than 75 years of cumulated experience in insulin formulation: More than 40 patents on insulin products 8 clinical trials with insulin products 60 R&D staff dedicated to insulin projects Author unknown November 2014 Property of ADOCIA

6 Insulin: more than 90 years of progress towards a more physiological treatment
BC LISPRO BC COMBO HINSBET November 2014 Property of ADOCIA

7 ADOCIA: a solid and diversified portfolio of products
November 2014 Property of ADOCIA

8 Evolution of the stock over 2014
Phase II dose response UF Lispro Results Lispro 300U Project Phase IIa UF Lispro Results Start of Phase II dose response UF Lispro Start of Phase IIa Hinsbet DFU Patent Phase II combo Results Start of Phase III BC PDGF-BB ADR Start of Phase IIa UF Lispro IPO: €15.88 ADA posters Increase of the share price (€5.97 on 1st January - €30 on 29th October), associated with an increase of the shares average trading volume (6,200 in and > 50,000 in 2014) November 2014 Property of ADOCIA

9 Technology November 2014 Property of ADOCIA

10 BioChaperone®: A new concept based on molecular assembly
Insulin, Growth factors, mAbs… BioChaperone’s uniqueness for proteins formulation: Enhance protein solubility in physiological conditions Stabilize proteins against aggregation Protect proteins against enzymatic degradation Medical and economical advantages expected: Improved efficacy of existing treatments Improved observance (reduced administration frequency, new combinations…) Improved pharmaco-economics (higher efficacy/lower quantities of protein) Technology patented until 2033 November 2014 Property of ADOCIA

11 Products breakthrough
Insulin therapy Wound healing Oncology November 2014 Property of ADOCIA

12 Diabetes: a significant and growing pandemic
Diabetics 382 M Diabetics 206 M Diagnosed +55% 95 M Treated 2013 2035 November 2014 Property of ADOCIA Adapted from International Diabetes Federation, Diabetes Atlas, 6th Edition, 2013

13 Treatment intensification
Insulin is the ultimate treatment for type 2 diabetes patients, and the only option for type 1 diabetes patients Oral Antidiabetics GLP-1 Insulin 25% Treated diabetics use Insulin Disease progression $23 B Treatment intensification November 2014 Property of ADOCIA

14 Two major types of insulin products
7 B$ 70 60 50 40 30 20 10 Insulin (µU/mL) 6:00 10:00 14:00 18:00 22:00 2:00 Breakfast Lunch Dinner Basal insulins (Lantus®, Levemir®, Tresiba®) Prandial insulins (Humalog®, Novolog®, Humulin®…) 10 B$ November 2014 Property of ADOCIA (1) Figures for 2013, based on data from Novo Nordisk, Full year 2013 presentation Feb 2014; Companies Financial reports 4Q13 & Sanofi’s Annual Report 2013.

15 Our innovative portfolio meets the challenges raised by the new insulin landscape
Lantus Insuman Aspart Lispro Apidra Afrezza Glargine 300 Novolin Levemir Tresiba Novolog Novomix Ryzodeg Once-a-week UltrafastFA ins aspart Humalog BC Combo Glargine/Fast Humalog Mix Humulin Ultrafast BC Lispro U100 HinsBet Lispro U200 PEG Lispro Glargine U200 Glargine Lispro Insugen Aspart ADOCIA as a “garden centre” Wosulin Glargine Glargine Glargine Gansulin Aspart November 2014 Property of ADOCIA

16 Insulin products: $22.9 billion(1), CAGR 15.7% (2008-2013)(1)
Human insulin market: $3.5 billion Insulin analogs market: $19.4 billion Human Insulin Fast acting Analogs Long acting Insulins Premixed Insulins Insulin Combos (long+fast-acting) Novo Nordisk Novolin N & R ($2.0 B) NovoLog® ($3,1 B) 2014* Levemir® ($2,1B) 2018* Tresiba® (Europe/Japan) 2024* Novomix® ($1.8 B) Ryzodeg® (Europe/Japan) Eli Lilly Humulin family ($1.3 B) Humalog® ($1,95 B) 2013* / Humalogmix® ($0,65 B) Sanofi Insuman® ($0.2 B) Apidra® ($0.4 B) 2017* Lantus® ($7.8 B) 2015* * Year product is off-patent Our challenge: bring innovation to existing products which will soon be off-patent November 2014 Property of ADOCIA Sources: (1) Novo Nordisk, Full year 2013 presentation Feb 2014; All other figures: Companies Financial reports 4Q13, except Apidra and Insuman: Sanofi’s Annual Report 2013.Humalog/HumalogMix split by Adocia’s estimate

17 BioChaperone for Prandial Insulins
November 2014 Property of ADOCIA

18 Medical need for ultra-fast insulins
Improved medical benefit Injection adapted to the actual meal Ultra-fast insulins Less hyper-glycemic events Less hypo-glycemic events November 2014 Property of ADOCIA

19 Severely insulin- resistant
Patients needs will drive the development of a range of ultra-fast products ULTRA-FAST INSULIN Children Pump users Severely insulin- resistant 40% American T1D use pumps1 86% Overweight T2D2 High performance Smaller injected volumes Less pain Mealtime dosing for better accuracy Real-time dosing Smaller pumps for better QoL “Standard” U100 “Concentrated” U200 November 2014 Property of ADOCIA Sources: 1Medtronic, 2010 ; 2Daousi et al (2006) Postgrad Med J 2006;82:

20 New products in development to meet the trends
BC Analog Phase 2 Humalog U200 EU approved Towards higher concentration Current insulin analogs FIAsp Phase 3 Afrezza US approved Towards faster action Adocia develops a unique portfolio of “ultra-fast AND concentrated” insulins November 2014 Property of ADOCIA

21 Mean Serum insulin level
ADOCIA Ultra-fast insulins Ultra-fast BC Lispro U100 Results of phase 2a trial on 36 Type 1 Diabetic patients Pharmacokinetics « faster-in » and « faster-out » Mean Serum insulin level 69 min These results were presented at conferences: November 2014 Property of ADOCIA Double–blind study, randomized, cross-over study on 36 Type 1 Diabetic patients under euglycemic clamp; BC Lispro (100 IU) vs. Humalog (100IU)

22 Phase 2a trial on 36 T1D patients Pharmacodynamics
ADOCIA Ultra-fast insulins Ultra-fast BC Lispro U100 Phase 2a trial on 36 T1D patients Pharmacodynamics Mean Glucose Infusion Rate These results were presented at conferences: November 2014 Property of ADOCIA Double-blind, randomized, cross-over study on 36 Type 1 Diabetic patients under euglycemic clamp; BC Lispro vs. Humalog 100 IU

23 ADOCIA Ultra-fast insulins
Ultra-fast BC Lispro U100 Dose-exposure results for BC Lispro U100 (PK) Second Phase IIa on 36 Type 1 diabetic patients Normalized at 0.1 U/kg BC Lispro 0.4 U/kg BC Lispro 0.2 U/kg BC Lispro 0.1 U/kg Across a standard therapeutic dose range BioChaperone Lispro U100 : Confirms Ultra-fast absorption profile Shows dose-exposure proportionality (R²>0.95) November 2014 Property of ADOCIA

24 ADOCIA Ultra-fast insulins
Ultra-fast BC Lispro U100 Dose-response results for BC Lispro U100 (PD) Second Phase IIa on 36 Type 1 diabetic patients BC222 Lispro 0.4 U/kg BC222 Lispro 0.2 U/kg BC222 Lispro 0.1 U/kg Across a standard therapeutic dose range, BioChaperone Lispro U100 shows: Ultra-fast metabolic effect Linear increase of early and total metabolic effects with dose (R²>0.98) November 2014 Property of ADOCIA

25 Clinical trials with BioChaperone Lispro Conclusions
ADOCIA Ultra-fast insulins Ultra-fast BC Lispro U100 Clinical trials with BioChaperone Lispro Conclusions After being tested in 73 patients and 147 injections, BioChaperone Lispro: Is significantly faster than Humalog® Presents a clinically robust performance across two different studies Shows a proportional dose exposure across a therapeutically relevant dose range Is well tolerated in humans November 2014 Property of ADOCIA

26 BC Lispro U100 Next key steps for the clinical development
ADOCIA Ultra-fast insulins Ultra-fast BC Lispro U100 BC Lispro U100 Next key steps for the clinical development Meal test study in type 1 diabetes using insulin pump to demonstrate medical benfit  Clinical trial planned in Q1 2015 Simplified development plan, following Novo Nordisk’s FIAsp’s (ultra-fast Novolog) plan Preparation of meetings pre-IND (FDA) & Scientific Advice (EMA) to validate the development plan expected Q1 2015 Phase III clinical trials could start Q1 2016 November 2014 Property of ADOCIA

27 Innovation for everyone, everywhere
Prandial insulins HinsBet® Innovation for everyone, everywhere 80% diabetics live in developing countries November 2014 Property of ADOCIA Source: International Diabetes Federation, Diabetes Atlas, 6th Edition, 2013

28 Emerging markets: similar needs, different constraints
Prandial insulins HinsBet® Emerging markets: similar needs, different constraints Large populations to treat Strong economic constraints …But same medical needs Better glycemic control Prevention of long term complications November 2014 Property of ADOCIA

29 Human insulin is the best-selling insulin in developing countries
Prandial insulins HinsBet® Human insulin is the best-selling insulin in developing countries 58% of Novo’s insulin sales in China are human insulin Large human insulin manufacturing capabilities in Asia RHI is more cost-effective than analogs RHI is 100% reimbursed in China BUT RHI action starts 15 min later than insulin analogs HinsBet®: a human insulin as fast as an insulin analog November 2014 Property of ADOCIA

30 HinsBet, a fast-acting human insulin
Prandial insulins HinsBet® HinsBet, a fast-acting human insulin Mean PD results (pig model) HinsBet NovoLog (aspart) Actrapid (human insulin) Results for Phase 2a study are expected Q1 2015 November 2014 Property of ADOCIA

31 BioChaperone for Glargine-based Combo
November 2014 Property of ADOCIA

32 Many patients have difficulties with multi-daily insulin injections
BioChaperone Combo Many patients have difficulties with multi-daily insulin injections Basal/Bolus Users Premix Users Obese & poor self-image Not confident or not willing to handle injections Semi-compliant patients Elderly Issues with multiple injections Other issues: health literacy, cost… Patients in need of simplicity Poor compliance & self-management Poor medical performance Glargine market $8bn Premix market $2.4bn HbA1c November 2014 Property of ADOCIA Glasgow RE. et al. Diabetes spectrum 2001 ; Skinner TC & Hampson SE Diabetes Care 2001; Gherman A et al. Pract Diab Int 2011

33 BioChaperone for Combo: Solubilizing Glargine for a real “2-in-1”
BioChaperone Combo BioChaperone for Combo: Solubilizing Glargine for a real “2-in-1” Improved Compliance Improved HbA1c Patients’ needs Easy handling Simpler regimen Fewer injections Doctors’ requirements Fast prandial action Once-a-day basal Flexible dosage Reconciling patients and physicians on treatment intensification November 2014 Property of ADOCIA

34 Mean Glucose Infusion Rate
BioChaperone Combo Phase 2a clinical trial in 20 Diabetics Type 1 (PD) Basal action >24h, ultra-fast prandial action Mean Glucose Infusion Rate BioChaperone Combo HumalogMix 25® 168 min p=0.01 204 min Tonset -37% (p=0.002) AUC GIR 0-2h +58% (p=0.001) AUC GIR h +57% (p=0.025) November 2014 Property of ADOCIA Double –blind, randomized, cross-over study on 20 Type 1 Diabetics patients under euglycemic clamp; BC Combo (Glargine 300 IU/Lispro 100 IU) vs. HumalogMix 25

35 BioChaperone Combo Phase 2a clinical trial in 20 Diabetics Type 1 (PD) Basal action >24h Mean blood glucose BioChaperone Combo HumalogMix 25® Number of patients with duration ≥ 30h 17/19 for BC Combo vs. 6/20 for Premix (p=0.001) November 2014 Property of ADOCIA Double –blind, randomized, cross-over study on 20 Type 1 Diabetics patients under euglycemic clamp; BC Combo (Glargine 300 IU/Lispro 100 IU) vs. HumalogMix 25

36 BioChaperone Combo BioChaperone Glargine Lispro Combo may present unique advantages over Novo Nordisk’s Ryzodeg® Ryzodeg® (Novo Nordisk) medical benefits in clinical trials: Improved fasted glucose control Faster achievement of HbA1c target Less insulin consumption Lower rate of hypoglycemia ADOCIA’s BioChaperone Combo advantages over Ryzodeg® (Novo Nordisk) Insulin Glargine long safety and efficacy track-record (>15 years) Potential faster prandial action (based on the results of Phase I/II of the two products) Low cost of production November 2014 Property of ADOCIA Source: Novo Nordisk, based on trial NN and NN

37 Next steps for BioChaperone Combo
Phase IIa dose-response clinical study starting Q1 2015 36 Type 1 Diabetic patients Dose-exposure relationship measurement Simplified development plan relying on glargine/lispro existing results Preparation of meetings pre-IND (FDA) & scientific advice (EMA) to validate the development plan Phase III program could start in Q1 2016 November 2014 Property of ADOCIA

38 BioChaperone Insulin portfolio: ‘Best-in-class’ products
2nd Generation ‘Gold-standard’ 1st Generation + BioChaperone Insulin BC-Insulin Simple Short clinical trial Safe and well tolerated Established safety and efficacy Part of patients’ everyday life Efficacy Medical benefit November 2014 Property of ADOCIA

39 Next developments milestones in BioChaperone insulins
Product Event Expected timeline HinsBet Results Phase IIa on type 1 diabetics Q1 15 BC Combo Launch Dose-response Phase IIa on type 1 diabetics BioChaperone Lispro U100 Pump study, Phase IIa on type 1 diabetics BioChaperone Lispro U200 Start Phase I/II on type 1 diabetics November 2014 Property of ADOCIA

40 Product Breakthrough Insulin therapy Wound healing Oncology
November 2014 Property of ADOCIA

41 Diabetic Foot Ulcer (DFU): a life-threatening disease
15% of diabetic patients will develop a DFU Diabetic Foot Ulcer Neuropathy & Ischemia Chronic hyperglycemia 60 % Neuroischemic patients in Western countries November 2014 Property of ADOCIA 1 Armstrong, D. G. et al Int Wound J 2007, 4 (4),

42 Wound healing potential market
Organo-genesis ADOCIA Smith & Nephew, DermaSciences Urgo, Convatec, Mölnlycke, Systagenix…. - + Severity of disease Cellular therapies~ $10,000, Complex management Biologics~ $1,500 Only approved product for DFU: Regranex® (PDGF-BB) Dressings ~$200 November 2014 Property of ADOCIA

43 Advantages of BioChaperone PDGF-BB vs Regranex®
Easy to use and convenient Applied once every two days (vs. daily for Regranex®) Ready-to-use spray Sterile without preservatives Multi-uses for 6 weeks Stable up to 3 months at 30°C and 30 months at 5°C Cost effective 1/3 of PDGF dosage vs. Regranex® Reduced cost of treatment due to reduced frequency of application BioChaperone PDGF-BB spray meets the requirements for a first-line advanced wound care treatment November 2014 Property of ADOCIA

44 BC PDGF-BB is non-inferior to Regranex at a third the dosage, applied half as often
Phase I/II study in 200 diabetic patients in India Incidence of complete wound closure after 20 weeks 79% 38/48 Once every 2 days Weekly dose divided by 3 Once a day 66% 31/47 November 2014 Property of ADOCIA Registered in clinical trials.gov under the #NCT ; 192 patients (both neuroischemic and neuropathic). Phase II multicenter, open-label, controlled, randomized trial.

45 BioChaperone PDGF Two products for two markets
Clinical proof of concept established in Phase I/II on DFU (India) 60-80% Neuropathic 60% Neuroischemic Emerging markets Western markets WHO-GMP PDGF cGMP PDGF Phase III launched Aug (India) EMA-validated shortened clinical development plan Phase III results expected Q1 16 Pre-IND meeting planned Q2 15 European Phase III Q4 15 Next steps November 2014 Property of ADOCIA

46 BioChaperone PDGF: Phase III clinical study launched in India
DCGI approval received August 22, 2014 Phase III clinical study 252 DFU patients– 25 to 30 investigators centers Biochaperone PDGF-BB vs. placebo Goal of the study: Confirm product effectiveness Principal criteria: Complete wound healing after max 20 weeks of treatment Secondary criteria: Wound healing in 10 weeks & Recurrence rate (3 months after wound closure) Support marketing approval in India and other emerging countries Act as supportive data to a Phase III trial in Europe for EU registration November 2014 Property of ADOCIA

47 Jean-Charles Kerihuel MD
Adocia’s BC PDGF-BB is supported by an international Medical Advisory Board “The committee was enthusiastic about BC PDGF-BB and the results obtained during Adocia’s first Indian trial and will support the development of BioChaperone PDGF‐BB in western as well as in emerging countries”. Jan Apelqvist MD, PhD Michaël Edmonds MD Jean-Charles Kerihuel MD Sylvie Meaume MD, PhD Stephan Morbach MD David Armstrong DPM, PhD, MD Akita Sadanori MD, PhD Terry Treadwell MD November 2014 Property of ADOCIA

48 Products breakthrough
Insulin therapy Wound healing Oncology November 2014 Property of ADOCIA

49 ADOCIA in Oncology Monoclonal Antibodies Formulation DriveIn®
Improve mAb solubility Reduce viscosity in highly concentrated solution Improve stability upon storage Targeted delivery for chemotherapy Biomimetic hyaluronan-based Trojan horse 2 ongoing partnerships with major pharmaceutical companies Phase 1 planned to start Q4 2015 November 2014 Property of ADOCIA

50 Financial Statements November 2014 Property of ADOCIA

51 2014 half year results: brief statement of accounts
In € thousands (IFRS rules) 30/06/2014 30/06/2013 Variation Revenue 0,2 0,9 Other income 1,7 1,8 Total income 1,9 2,7 -30% Operating expenses (7,4) Profit/loss from operating activities (5,6) (4,6) -21% Net profit/loss after tax (5,5) -20% November 2014 Property of ADOCIA

52 Results end of September 2014 and balance sheet details
Turnover end of September: €0.2M (collaboration agreements on mAbs) versus €5.6M in 2013 (depreciation balance on the initial payment from Lilly) Cash position end of September 2014: €12.6M Burn rate on the first three quarters in 2014: €6.8M (€3.2M cash in June 2014 of the tax credit research on 2013 spending) Long term debt: €1.8M loan from BPI France (refundable only in case of commercial and/or technical success) November 2014 Property of ADOCIA

53 Shareholders as of September 30, 2014
Shareholders equity Listed on Euronext Paris since February 2012 6.2 million shares, with a float nearly 44% (*) Market capitalization (end of Oct 2014) = €190M ADR Program with BNY since May 2014 (ADOCY) Analysts: Kepler Market (Lionel Labourdette) Invest Securities (Daniel Anizon) Life Sci Advisors (Andrew I. Mc Donald) (*) including, where appropriate, the shares held by existing investors of the company November 2014 Property of ADOCIA

54 ADOCIA – Next steps November 2014 Property of ADOCIA

55 ADOCIA – Next steps Product / Technology Therapeutic area Event
Expected timeline HinsBet Diabetes Phase IIa study results Q1-2015 Biochaperone Combo Phase IIa dose-response study launch Biochaperone Lispro U100 Phase II on type 1 diabetics , pump study, launch Biochaperone Lispro U200 Phase I/II study launch mAbs technologies Depending on partner Ongoing collaborative developments - DriveIn Oncology Phase I launch Q4-2015 BC PDGF-BB Phase III – Europe study launch Phase III – India n study Results Q1-2016 November 2014 Property of ADOCIA

56 Thank you for your kind interest
Persons depicted in this document are models that are intended to enhance the presentation. They are not affected by any disease or treatments mentioned in this present document. November 2014 Property of ADOCIA


Download ppt "ADOCIA – CORPORATE PRESENTATION"

Similar presentations


Ads by Google