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

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Presentation on theme: "ADOCIA – CORPORATE PRESENTATION Actionaria event – Palais des Congrès Paris, France – November 21-22, 2014."— Presentation transcript:

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

2 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. Disclaimer November 2014Property of ADOCIA2

3 ADOCIA - Management Gérard SoulaOlivier Soula Valérie DanaguezianRémi Soula President & CEODeputy General Manager Chief Financial OfficerBusiness Development R&D Director & Intellectual Property Director Property of ADOCIA 3 November 2014

4 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 ADOCIA in brief November 2014Property of ADOCIA4

5 November 2014Property of ADOCIA5 ADOCIA A unique excellence center for innovative insulin formulation Author unknown 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 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

6 Insulin: more than 90 years of progress towards a more physiological treatment November 2014Property of ADOCIA6 BC LISPRO BC COMBO HINSBET

7 ADOCIA: a solid and diversified portfolio of products November 2014Property of ADOCIA7

8 November Evolution of the stock over 2014 Increase of the share price (€5.97 on 1 st January - €30 on 29 th October), associated with an increase of the shares average trading volume (6,200 in 2013 and > 50,000 in 2014) Property of ADOCIA ADR Phase IIa UF Lispro Results Lispro 300U Project IPO: €15.88 ADA posters Start of Phase IIa UF Lispro Phase II combo Results Start of Phase IIa Hinsbet Start of Phase III BC PDGF-BB Start of Phase II dose response UF Lispro DFU Patent Phase II dose response UF Lispro Results

9 Technology November 2014Property of ADOCIA9

10 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 BioChaperone ® : A new concept based on molecular assembly 10November 2014Property of ADOCIA Insulin, Growth factors, mAbs…

11 1.Insulin therapy 2.Wound healing 3.Oncology Products breakthrough November 2014Property of ADOCIA11

12 Diabetes: a significant and growing pandemic Adapted from International Diabetes Federation, Diabetes Atlas, 6 th Edition, M Diagnosed 382 M Diabetics % 592 M Diabetics M Treated November 2014Property of ADOCIA12

13 Insulin is the ultimate treatment for type 2 diabetes patients, and the only option for type 1 diabetes patients Oral Antidiabetics Oral Antidiabetics GLP-1 GLP-1 Insulin 25% Treated diabetics use Insulin 25% Treated diabetics use Insulin Disease progression $23 B Treatment intensification November 2014Property of ADOCIA13

14 Two major types of insulin products Insulin (µU/mL) 6:0010:0014:0018:0022:002:006:00 BreakfastLunchDinner Basal insulins (Lantus ®, Levemir ®, Tresiba ® ) Prandial insulins (Humalog ®, Novolog ®, Humulin®…) (1) Figures for 2013, based on data from Novo Nordisk, Full year 2013 presentation Feb 2014; Companies Financial reports 4Q13 & Sanofi’s Annual Report November 2014Property of ADOCIA 14 7 B$ 10 B$

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

16  Human insulin market: $3.5 billion  Insulin analogs market: $19.4 billion Insulin products: $22.9 billion (1), CAGR 15.7% ( ) (1) Our challenge: bring innovation to existing products which will soon be off-patent Human Insulin Fast acting Analogs Long acting InsulinsPremixed 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) / SanofiInsuman ® ($0.2 B) Apidra ® ($0.4 B) 2017 * Lantus ® ($7.8 B) 2015 * // * Year product is off-patent 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 Property of ADOCIA 16 November 2014

17 BioChaperone for Prandial Insulins November 2014Property of ADOCIA17

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

19 November 2014Property of ADOCIA19 Patients needs will drive the development of a range of ultra-fast products Children Pump users Severely insulin- resistant 40% American T1D use pumps 1 86% Overweight T2D 2 Mealtime dosing for better accuracy Real-time dosing Smaller pumps for better QoL High performance Smaller injected volumes Less pain ULTRA-FAST INSULIN “Standard” U100 “Concentrated” U200 Sources: 1 Medtronic, 2010 ; 2 Daousi et al (2006) Postgrad Med J 2006;82:

20 November 2014Property of ADOCIA20 New products in development to meet the trends Towards higher concentration Towards faster action Humalog U200 EU approved Current insulin analogs FIAsp Phase 3 FIAsp Phase 3 Afrezza US approved Afrezza US approved BC Analo g Phase 2 Adocia develops a unique portfolio of “ultra-fast AND concentrated” insulins

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

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

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

24 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 November 2014Property of ADOCIA 24 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) ADOCIA Ultra-fast insulins Ultra-fast BC Lispro U100 ADOCIA Ultra-fast insulins Ultra-fast BC Lispro U100

25 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 Clinical trials with BioChaperone Lispro Conclusions November 2014Property of ADOCIA25 ADOCIA Ultra-fast insulins Ultra-fast BC Lispro U100 ADOCIA Ultra-fast insulins Ultra-fast BC Lispro U100

26 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 Q 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 Q Phase III clinical trials could start Q November 2014Property of ADOCIA26 ADOCIA Ultra-fast insulins Ultra-fast BC Lispro U100 ADOCIA Ultra-fast insulins Ultra-fast BC Lispro U100

27 Innovation for everyone, everywhere Source: International Diabetes Federation, Diabetes Atlas, 6 th Edition, % diabetics live in developing countries November 2014Property of ADOCIA27 Prandial insulins HinsBet ® Prandial insulins HinsBet ®

28 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 2014Property of ADOCIA28 Prandial insulins HinsBet ® Prandial insulins HinsBet ®

29 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 2014Property of ADOCIA 29 Prandial insulins HinsBet ® Prandial insulins HinsBet ®

30 HinsBet, a fast-acting human insulin HinsBet NovoLog (aspart) Actrapid (human insulin) Results for Phase 2a study are expected Q Mean PD results (pig model) November 2014Property of ADOCIA30 Prandial insulins HinsBet ® Prandial insulins HinsBet ®

31 BioChaperone for Glargine-based Combo November 2014Property of ADOCIA31

32 Many patients have difficulties with multi-daily insulin injections Glasgow RE. et al. Diabetes spectrum 2001 ; Skinner TC & Hampson SE Diabetes Care 2001; Gherman A et al. Pract Diab Int 2011 Poor medical performance Poor compliance & self-management HbA1c 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 Basal/Bolus Users Premix Users November 2014Property of ADOCIA32 Premix market $2.4bn Premix market $2.4bn Glargine market $8bn BioChaperone Combo

33 November 2014Property of ADOCIA33 BioChaperone for Combo: Solubilizing Glargine for a real “2-in-1” Doctors’ requirements Fast prandial action Once-a-day basal Flexible dosage Patients’ needs Easy handling Simpler regimen Fewer injections Improved Compliance Improved HbA1c Reconciling patients and physicians on treatment intensification BioChaperone Combo

34 Phase 2a clinical trial in 20 Diabetics Type 1 (PD) Basal action >24h, ultra-fast prandial action Mean Glucose Infusion Rate T onset -37% (p=0.002) AUC GIR 0-2h +58% (p=0.001) AUC GIR 12-30h +57% (p=0.025) BioChaperone Combo HumalogMix 25 ® 204 min 168 min p=0.01 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 November 2014Property of ADOCIA34 BioChaperone Combo

35 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 2014Property of ADOCIA 35 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 BioChaperone Combo

36 BioChaperone Glargine Lispro Combo may present unique advantages over Novo Nordisk’s Ryzodeg ® 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 2014Property of ADOCIA36 Ryzodeg ® (Novo Nordisk) medical benefits in clinical trials: Improved fasted glucose control Faster achievement of HbA1c target Less insulin consumption Lower rate of hypoglycemia Source: Novo Nordisk, based on trial NN and NN BioChaperone Combo

37 Next steps for BioChaperone Combo Phase IIa dose-response clinical study starting Q 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 Q November 2014Property of ADOCIA 37 BioChaperone Combo

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

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

40 1.Insulin therapy 2.Wound healing 3.Oncology Product Breakthrough November 2014Property of ADOCIA40

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

42 Wound healing potential market - + Severity of disease Cellular therapies~ $10,000, Complex management Biologics~ $1,500 Only approved product for DFU: Regranex ® (PDGF-BB) Dressings ~$200 Property of ADOCIA 42 November 2014

43 Advantages of BioChaperone PDGF-BB vs Regranex ® BioChaperone PDGF-BB spray meets the requirements for a first-line advanced wound care treatment 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 November 2014Property of ADOCIA43

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

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

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 Property of ADOCIA 46 November 2014

47 Property of ADOCIA47 “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”. Adocia’s BC PDGF-BB is supported by an international Medical Advisory Board Jan Apelqvist MD, PhD David Armstrong DPM, PhD, MD Terry Treadwell MD Michaël Edmonds MD Akita Sadanori MD, PhD Jean-Charles Kerihuel MD Sylvie Meaume MD, PhD Stephan Morbach MD

48 1.Insulin therapy 2.Wound healing 3.Oncology Products breakthrough November 2014Property of ADOCIA48

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

50 Financial Statements November 2014Property of ADOCIA50

51 2014 half year 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) Profit/loss from operating activities (5,6) (4,6) -21% Net profit/loss after tax (5,5) (4,6) -20% November 2014Property of ADOCIA51

52 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) Results end of September 2014 and balance sheet details November 2014Property of ADOCIA52

53 Listed on Euronext Paris since February 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) Shareholders as of September 30, 2014 Shareholders equity (*) including, where appropriate, the shares held by existing investors of the company November 2014Property of ADOCIA53

54 ADOCIA – Next steps November 2014Property of ADOCIA54

55 ADOCIA – Next steps Product / TechnologyTherapeutic areaEvent Expected timeline HinsBetDiabetesPhase IIa study resultsQ Biochaperone ComboDiabetesPhase IIa dose-response study launchQ Biochaperone Lispro U100Diabetes Phase II on type 1 diabetics, pump study, launch Q Biochaperone Lispro U200DiabetesPhase I/II study launchQ mAbs technologiesDepending on partnerOngoing collaborative developments- DriveInOncologyPhase I launchQ BC PDGF-BBDiabetesPhase III – Europe study launchQ BC PDGF-BBDiabetesPhase III – India n study ResultsQ Property of ADOCIA 55 November 2014

56 Contact SA au capital de ,60 € - RCS Lyon Tél avenue Lacassagne – Lyon 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 2014Property of ADOCIA56


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