ADOCIA CORPORATE PRESENTATION

Transcription

1 ADOCIA CORPORATE PRESENTATION

2 Disclaimer 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. September 2014 Property of Adocia 2

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 Property of Adocia 3

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 24 Ph.Ds Cash position close to 16 M at end of June 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 Oncology: DriveIn-Doxorubicin and DriveIn-Docetaxel, for the treatment of solid tumors September 2014 Property of Adocia 4

5 2014, an exceptional starting-up. Three major clinical results Ultra-fast BC Lispro tested on 36 Type 1 diabetic patients Higher performance compared to Humalog by 40% Interest from various companies on this product patented up to 2033 Ultra-fast BC Lispro tested at three different doses Proportional dose-exposure showed Confirmation of previous results BC Combo based with glargine and lispro tested on 20 Type 1 diabetic patients Higher performance compared to HumalogMix Interest from two companies for this unique product patented up to 2032 Three new clinical studies Biochaperone PDGF-BB, phase III clinical trial on 252 patients: launched! HinsBet, optimized formulation on 36 Type 1 diabetics: ongoing New clinical dose-response study on the BC glargine formulation: on preparation Increased visibility of Adocia Launch of ADR (American Deposit Receipt) program mnemonic: ADOCY Clinical results presented at American Diabete Association (ADA) and at European Association for the Study of Diabetes (EASD) September 2014 Property of Adocia 5

6 Evolution of the stock over the first months of 2014 Phase II combo Results Phase IIa UF Lispro Results Start of Phase II effet-dose UF Lispro Lispro 300U Project Start of Phase IIa Hinsbet Start of Phase III BC PDGF-BB IPO : 15,88 DFU Patent ADR Start of Phase IIa UF Lispro ADA posters Increase of the shareprice ( 5.97 on 1st January on 2 nd September), associated with an increase of the average exchanged volume (6.200 in 2013 and in 2014) September 2014 Property of Adocia 6

7 Adocia: a solid and diversified portfolio of products September 2014 Property of Adocia 7

8 Products breakthrough 1. Insulin therapy 2. Wound healing 3. Oncology September 2014 Property of Adocia 8

9 Diabetes: a significant and growing pandemic 95 M Treated 206 M Diagnosed 382 M Diabetics +55% 592 M Diabetics September 2014 Property of Adocia 9 Adapted from International Diabetes Federation, Diabetes Atlas, 6 th Edition, 2013

10 Insulin is the ultimate treatment for T2D patients, and the only option for T1D patients Treatment intensification $23 B Oral Antidiabetics GLP-1 Insulin 25% Treated diabetics use Insulin Disease progression September 2014 Property of Adocia 10

11 Two major types of insulin products 70 Prandial insulins (Humalog, Novolog, Apidra ) Insulin (µu/ml) Basal insulins (Lantus, Levemir, Tresiba ) 10 6:00 10:00 14:00 18:00 22:00 2:00 6:00 Breakfast Lunch Dinner September 2014 Property of Adocia 11 (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.

12 Insulin: more than 90 years towards a progress towards a more physiological treatment September 2014 Property of Adocia 12

13 but the insulin landscape is undergoing major changes Humalog BC Combo Glargine/Fast Oncea-week HinsBet September 2014 Property of Adocia 13

14 BioChaperone for Prandial insulins September 2014 Property of Adocia 14

15 Faster insulins enables meal-time dosing. - - September 2014 Property of Adocia 15

16 leading to better diabetes management Ultra-fast insulins Injection adapted to the real meal Improved medical benefit Less hyper-glycemic events Less hypo-glycemic events September 2014 Property of Adocia 16

17 Ultra-fast insulin is a major key for Prandial insulins BC Lispro Children Insulin pumps Artificial pancreas Better Treatment Dosage accuracy, adapted to the meal Improvement of the Regulation but also for all users of prandial insulin September 2014 Property of Adocia 17

18 Results of phase 2a trial on 36 Type 1 Diabetic patients CT006 Pharmacokinetics «faster-in» and «faster-out» Prandial insulins BC Lispro U100 Mean Serum insulin level September 2014 Property of Adocia 18 Double blind study, randomized, cross-over study on 36 Type 1 Diabetic patients under euglycemic clamp; BC Lispro (100 IU) vs. Humalog (100IU)

19 Phase 2a trial on 36 T1D patients Pharmacodynamics Prandial insulins BC Lispro U100 Mean Glucose Infusion Rate September 2014 Property of Adocia 19 Double-blind, randomized, cross-over study on 36 Type 1 Diabetic patients under euglycemic clamp; BC Lispro vs. Humalog 100 IU

20 Compiled results CT006-CT008 BC Lispro [Prelim.] Pharmacokinetics at 0.2 U/kg Prandial insulins BC Lispro U100 Phase 2a dose-response CT patients type 1 BC Lispro Humalog Zoom 0-2h Phase 2a CT patients type 1 BC Lispro Humalog The results of the new clinical trial CT008 confirm a faster absorption of BioChaperone Lispro compared to Humalog. September 2014 Property of Adocia 20

21 Compiled results CT006-CT008 BC Lispro [Prelim.] Pharmacodynamics at 0.2 U/kg Prandial insulins BC Lispro U100 Phase 2a dose-response CT patients type 1 BC Lispro Humalog Zoom 0-2h Phase 2a CT patients type 1 BC Lispro Humalog The faster absorption is confirmed by a pharmacological effect significantly earlier with BC Lispro. September 2014 Property of Adocia 21

22 CT008 BC Lispro results on 37 patients with T1 diabetes [Prelim.] Dose-exposure relationship Prandial insulins BC Lispro U100 BC Lispro 0.4 U/kg BC Lispro 0.2 U/kg BC Lispro 0.1 U/kg For a range of usual prandial insulin doses, BioChaperone Lispro presents an ultra-fast absorption profile. September 2014 Property of Adocia 22

23 CT008 BC Lispro results on 37 patients with T1 diabetes [Prelim.] Dose-exposure relationship Prandial insulins BC Lispro U100 Dose normalization at 0.1 U/kg BC Lispro 0.4 U/kg BC Lispro 0.2 U/kg BC Lispro 0.1 U/kg The dose normalization confirms the dose-exposure proportionality. September 2014 Property of Adocia 23

24 CT008 BC Lispro results on 37 patients with T1 diabetes [Prelim.] Dose-response relationship Prandial insulins BC Lispro U100 BC222 Lispro 0.4 U/kg BC222 Lispro 0.2 U/kg BC222 Lispro 0.1 U/kg Across the range of tested doses, BC Lispro shows an ultra-fast metabolic effect. September 2014 Property of Adocia 24

25 CT008 BC Lispro results on 37 patients with T1 diabetes [Prelim.] Dose-response relationship Prandial insulins BC Lispro U100 Dose normalization at 0.1 U/kg BC222 Lispro 0.1 U/kg BC222 Lispro 0.2 U/kg BC222 Lispro 0.4 U/kg A saturation of the metabolic effect was observed with increasing dose (expected pharmacological effect). A linear increase in early and total metabolic effects was demonstrated in a clinically relevant range of doses ( U/kg). September 2014 Property of Adocia 25

26 Clinical trials with BioChaperone Lispro Conclusions BioChaperone Lispro is an ultra-fast formulation: The absorption and the pharmacological effect are significantly faster than Humalog BioChaperone Lispro presents a clinical robustness performance: The results obtained in the first clinical study are confirmed The formulation presents a proportional dose-exposure relationship, which is shown by a linear dose response across the range of doses usually used by the patients with diabetes. BioChaperone Lispro is well tolerated in humans: No specific serious adverse events have been observed in these 2 trials Local tolerance is excellent with no local reaction at the site injection for the total 149 injections. September 2014 Property of Adocia 26

27 Medical interest of BioChaperone Lispro Conclusions BioChaperone Lispro could have a beneficial effect on all patients using prandial insulins: Flexibility gain on the injection time: Pediatric population Patients with type 1 diabetes Patients with type 2 diabetes Better control of the post-prandial glycaemia: Patients using insulin pens or/and syringes Users of pumps BioChaperone Lispro could lead to new innovations: The ultra-fast PKPD profile is needed for the development of an artificial pancreas September 2014 Property of Adocia 27

28 BC Lispro U100 Next key steps for the clinical development Prandial insulins BC Lispro U100 Glycaemia regulation study, post meal, on patients with type 1 diabetes using insulin pump to prove the medical advantage Clinical trial planned in Q Simplified development plan, following the FIAsp of Novo Nordisk (ultra-fast Novolog) Preparation of meetings pre-ind (FDA) & scientific advice (EMA) to validate the development plan expected 1Q 2015 Phase III clinical trials could be launched starting with 4Q 2015 September 2014 Property of Adocia 28

29 Concentrated, ultra-fast insulin for patients requiring higher doses Prandial insulins BC Lispro U300 Obesity 86% Overweight Type 2 diabetics (2006 study) 1 Severe insulin resistance High insulin doses Need for concentrated ultra fast-acting insulin 1 Daousi et al (2006) Postgrad Med J 2006;82: September 2014 Property of Adocia 29

30 BC Lispro U300 ultra-fast acting Prandial insulins BC Lispro U300 Mean PD results (pig model) 1 st concentrated ultra-fast acting insulin BioChaperone Lispro U300 Humalog U100 Phase I/II planned 1Q 2015 September 2014 Property of Adocia 30

31 Innovation for everyone, everywhere Prandial insulins HinsBet 80% diabetics live in developing countries September 2014 Property of Adocia 31 Source: International Diabetes Federation, Diabetes Atlas, 6 th Edition, 2013

32 Emerging markets: similar needs, different constraints Prandial insulins HinsBet Large populations to treat Strong economic constraints But same medical needs Better glycemic control Prevention of long term complications September 2014 Property of Adocia 32

33 Human insulin is number one in the developing countries Prandial Insulins HinsBet 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: an human insulin as fast as an insulin analog September 2014 Property of Adocia 33

34 HinsBet, a fast-acting human insulin Prandial insulins HinsBet Mean PD results (pig model) HinsBet NovoLog (aspart) Actrapid (human insulin) Phase 2a dose-response study launched beginning of July 2014 September 2014 Property of Adocia 34

35 BioChaperone for Glargine-based Combo September 2014 Property of Adocia 35

36 Many patients have difficulties with multi-daily insulin injections BC Combo Basal/Bolus Users Semi-compliant patients Obese & poor self-image Not confident or not willing to handle injections Premix Users Non sophisticated patients Elderly Issues with multiple injections Other issues: health literacy, cost Poor compliance & self-management Poor medical performance HbA1c Part of Glargine $8bn Premix $2.4bn September 2014 Property of Adocia 36 Glasgow RE. et al. Diabetes spectrum 2001 ; Skinner TC & Hampson SE Diabetes Care 2001; Gherman A et al. Pract Diab Int 2011

37 Goal: Delivering Glargine & Prandial insulins in a single injection BC Combo Once-a-Day Improved Compliance Fewer injections Easier treatment management Decreased social hindrance HbA1c < 7% Improved HbA1c Faster prandial action Longer basal effect Reconciling patients and physicians about the intensification of insulin therapy September 2014 Property of Adocia 37

38 Results Phase 2a clinical trial in 20 Diabetics Type 1 patients Basal acting >24h, ultra-fast acting prandial BC Combo Mean Glucose Infusion Rate 168 min p= min BioChaperone Combo HumalogMix 25 T onset AUC GIR 0-2h AUC GIR 12-30h -37% (p=0.002) +58% (p=0.001) +57% (p=0.025) September 2014 Property of Adocia 38 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

39 BioChaperone Combo: basal acting >24h, Phase 2a clinical trial, 20 Type 1 Diabetics BC Combo 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) September 2014 Property of Adocia 39 Etude double-aveugle, randomisée, croisée sur 20 diabétiques de type 1 sous clamp euglycémique; BC Combo (Glargine 300 IU/Lispro 100 IU) vs. HumalogMix 25

40 BioChaperone Glargine Lispro Combo has unique advantages BC Combo BioChaperone Glargine advantages vs. Ryzodeg Insulin Glargine long safety and efficacy track-record Potential faster prandial action (based on the results of Phase I/II of the two products) Low cost of production September 2014 Property of Adocia 40

41 Insulins Combo improves medical benefit vs Premix: Ryzodeg (Novo Nordisk) clinical results Improved fasted glucose control Faster achievement of HbA1c target Less insulin consumption Lower rate of hypoglycemia BC Combo is nowadays a direct competitor to Novo s Ryzodeg September 2014 Property of Adocia 41 Source: Novo Nordisk, based on trial NN and NN

42 Next steps for BioChaperone Combo BC Combo Phase IIa dose-response clinical study expected 4Q Type 1 Diabetic patients Dose-exposure relationship measurement Euglycemic clamp Double-blind, randomized, 4-periods crossover Each patient will receive 4 injections of insulin: BC Combo with 3 different doses, and HumalogMix25 with 1 dose 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 1Q 2016 September 2014 Property of Adocia 42

43 Next developments milestones in BioChaperone insulins Product Event Expected timeline BC Combo HinsBet BioChaperone Lispro U100 BioChaperone Lispro U300 Start Dose-response Phase IIa 4Q 14 Results Dose-response Phase IIa 4Q 14 Start Pump study, post meal Phase IIa 1Q 15 Start Phase I/II on type 1 diabetics 1Q 15 September 2014 Property of Adocia 43

44 BioChaperone Insulin portfolio: Best-in-class products Gold-standard 1 st Generation Best-in-class 2 nd Generation + BioChaperone Established safety and efficacy Daily part of patient lives Simple Short clinical trial Safe and well tolerated Efficacy Medical benefit September 2014 Property of Adocia 44

45 Product Breakthrough 1. Insulin therapy 2. Wound healing 3. Oncology September 2014 Property of Adocia 45

46 Diabetic Foot Ulcer (DFU): a life-threatening disease 10 Million people affected Chronic hyperglycemia Neuropathy & Ischemia Diabetic Foot Ulcer 60 % Neuroischemic patients in Western countries 1 Armstrong, D. G. et al Int Wound J 2007, 4 (4), Property of Adocia 46

47 Wound healing potential market + Severity of disease - S&N ADOCIA Smith&Nephew, DermaSciences Urgo, Convatec, Mölnlycke, Systagenix. Cellular therapies~ $10,000 Biologics~ $1,500 Only approved product for DFU: Regranex (PDGF-BB) Dressings ~$200 Property of Adocia 47

48 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 BioChaperone PDGF-BB spray meets the requirements for a first-line advanced wound care treatment September 2014 Property of Adocia 48

49 BioChaperone PDGF-BB as efficient as Regranex Phase I/II study on 200 diabetic patients in India Incidence of complete wound closure after 20 weeks Once a day 66% 31/47 79% 38/48 Once every 2 days Registered in clinical trials.gov #NCT ; 192 patients (both neuroischemic and neuropathic) Property of Adocia 49

50 BioChaperone PDGF Two products for two markets Clinical proof of concept established in Phase I/II on DFU (India) 80% Neuropathic Emerging markets WHO-GMP PDGF Western markets cgmp PDGF 60% Neuroischemic Phase III clinical trial dossier filed (India) EMA-validated shortened clinical development plan Phase III study launched September 2014 Next steps Pre-IND meeting planned 2Q 15 European Phase III 4Q 15 Property of Adocia 50

51 BioChaperone PDGF: Phase III clinical study launched in India Approval by DCGI received August 22, 2014 Phase III clinical study 252 diabetic patients presenting a diabetic foot ulcer Comparing Biochaperone PDGF-BB to placebo investigators centers Study to be managed by the CRO Makrocare Investigators meeting on September 6, in Hyderabad Goal of the study: to confirm the effectiveness of the product Obtain the data to support marketing approval in India and other emerging countries Support the results of an Phase III trail in Europe Principal criteria: Complete wound healing after a maximum of 20 weeks of treatment Secondary criteria: Wound healing in 10 weeks Recurrence rate of the wound healing after 3 months Results expected 1Q2016 Property of Adocia 51

52 Products breakthrough 1. Insulin therapy 2. Wound healing 3. Oncology September 2014 Property of Adocia 52

53 Adocia in Oncology Monoclonal Antibodies Formulation DriveIn To improve the solubility To reduce viscosity in highly concentrated solution To improve the stability in storage 2 ongoing partnerships with major pharmaceutical companies Targeted delivery for chemotherapy Biomimetic hyaluronan-based Trojan horse Phase 1 planned to start 4Q 2015 September 2014 Property of Adocia 53

54 Financial Statements September 2014 Property of Adocia 54

55 2014 Annual results: brief statement of accounts In thousands (IFRS rules) 30/06/ /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) (7,4) Profit/loss from operating activities (5,6) (4,6) -21% Net profit/loss after tax (5,5) (4,6) -20% September 2014 Property of Adocia 55

56 2014 Annual results: published key figures Cash position end of June 2014: 15,9M Burnt rate on the 1st quarter 2014: 3,5M (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) September 2014 Property of Adocia 56

57 Shareholders as of June 30, 2014 Listed on Euronext Paris since February ,2 million shares, with a float of 37% (*) Market capitalization = 100M Shareholders equity ADR Program with BNY since May 2014 (ADOCY) Analysts: Kepler Market (Lionel Labourdette) Invest Securities (Daniel Anizon) Life Sci Advisors (Andrew I. Mc Donald) (*) incluant, le cas échéant, les actions détenues par les investisseurs historiques de la société September 2014 Property of Adocia 57

58 Adocia Next steps September 2014 Property of Adocia 58

59 Adocia Next steps Product / Technology Therapeutic area Event Expected timeline Biochaperone Combo Diabetes Phase IIa dose-response study launch 4Q-2014 Hinsbet Diabetes Phase IIa dose-response study results 4Q-2014 Biochaperone Lispro U100 Diabetes Phase IIa, pump study, post meal launch 1Q-2015 Biochaperone Lispro U300 Diabetes Phase I study launch 1Q-2015 mabs technologies Depending on partner Ongoing collaborative developments - DriveIn Oncology Phase I launch 4Q-2015 BC PDGF-BB Diabetes Phase III Europe study launch 4Q-2015 BC PDGF-BB Diabetes Phase III India Results 1Q-2016 Property of Adocia 59

60 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. Contact 115 avenue Lacassagne Lyon Tél SA au capital de ,60 - RCS Lyon September 2014 Property of Adocia 60