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June 2016
CORPORATE PRESENTATION
JUNE 7, 2016 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 speak only as of the date of this document and may be subject to significant changes. The Company does not undertake any obligation to update
the information or opinions contained herein in light of any new information or future developments.
The information contained in this document has not been independently verified. 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. Factors that may cause actual results to differ materially from those
contained in any forward-looking statements include the uncertainties relating to research and development, results of clinical trials, success of the Company’s collaboration agreements and decisions by
regulatory authorities regarding approval of the Company’s products, as well as those discussed or identified in the public filings made by the Company with the French Autorité des marchés financiers
(Financial Markets Authority). 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
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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
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Disclaimer INTRO
JUNE 7, 2016 3
Management Team ADOCIA
Gérard Soula PhD, MBA
Olivier Soula PhD, MBA
Valérie Danaguezian Rémi Soula PhD, MBA
Steve Daly
President & CEO
Co-founder
Deputy General Manager,
R&D Director
Co-founder
Chief Financial Officer Director of BD & IP
Co-founder
US General Manager
JUNE 7, 2016 4
Corporate Fact Sheet ADOCIA
Founded in 2005 by Gérard, Olivier & Rémi Soula
Focused on Diabetes treatments
Specializes in the development of innovative formulations of already-approved therapeutic proteins
Established expertise in insulin formulation
120 employees – 44PhDs
Portfolio based on BioChaperone proprietary platform
4 programs in clinical development
1 partnered with Eli Lilly
$22Bn3 global insulin
market
€400M market cap
(June 1, 2016)
415M1 people with
diabetes
25M2 insulin users
€62.4M cash position
1 International Diabetes Federation, Diabetes Atlas 2015 ; 2 Novo Nordisk estimates, 2016 ; 3 Adocia’s estimates, based on major player’s annual reports 2015
Preclinical Phase I/II Phase III
BC Lispro U100
BC Lispro U200
HinsBet U100
HinsBet U500
BC Combo
BioChaperone® Insulins – Diabetes
BioChaperone® PDGF-BB – Diabetic Foot Ulcer
BioChaperone® Glucagon – Diabetes & other indications
A portfolio of “super-biologics” focused on diabetes ADOCIA
~$5.7 bn
~$0.8 bn
~$4.7 bn
~$0.4 bn
Market Opportunity
5
Next Catalyst
$570M deal - $60M received $270M development milestones
remaining
Phase 2a expected results Q3 16
2 Phase 2a expected results Q1 17
1st in man Q1 17
Phase 3 expected results Q3 16 (India)
JUNE 7, 2016
JUNE 7, 2016 6
Adocia’s innovation could fill gaps in the diabetes portfolios of major players
ADOCIA
BC Glucagon
JUNE 7, 2016 7
Exclusive worldwide license for BioChaperone Lispro U100 & more concentrated formulations (U200)
$570M deal + tiered royalties on sales
Lilly responsible for future development, manufacturing, and commercialization
Lilly reimburses Adocia for certain R&D expenses
Since December 2014:
4 successful Phase 1b clinical studies (meal test, repeated admin T1D, repeated admin T2D, PK/PD in Japanese patients)
1 successful Pilot bioequivalence study (BC Lispro U200 vs. BC Lispro U100)
Triggered $10M payment from Lilly 1 ongoing Phase 1b clinical study (pump study in T1D)
Validating partnership with Eli Lilly ADOCIA
$570M deal
$270M development
MS
$240M sales MS
$10M U200
milestone $50M upfront
JUNE 7, 2016 8
BioChaperone unlocks the potential of proteins ADOCIA
BioChaperone Protein Complex
BioChaperone Lispro Faster diffusion & action
BioChaperone Combo Solubilisation of insulin glargine
at neutral pH
BioChaperone PDGF Protection against proteases
BioChaperone Glucagon Stabilisation at neutral pH
Library of more than 400 BioChaperone molecules
Strong IP protection (molecules, complexes,
formulations) with 30 patent families
Potential for medical and economic advantages
JUNE 7, 2016 9
Insulin treatment is a staple for both types of diabetes DIABETES
25M Insulin users
70% T2D
Basal + Prandial insulin
Basal insulin 1st
Intensification using
Prandial insulin
or
30%
T1D
JUNE 7, 2016 10
Insulin treatments aim to mimic different components of the healthy insulin secretion profile
INSULIN
Insulin secretion Insulin therapies action profiles
$7 B
$11 B
$5 B
BIOCHAPERONE LISPRO ULTRA RAPID INSULIN
JUNE 7, 2016 11
JUNE 7, 2016 12
Ultra-rapid insulins benefit various patient populations BC LISPRO
BIOCHAPERONE LISPRO
BC Lispro U100
BC Lispro U200
Dosing at or after mealtime
Tighter glycemic control
Ultra-rapid benefits with a reduced
injection volume
JUNE 7, 2016 13
Faster insulin action of BC Lispro translates into significantly improved glycemic control
BC LISPRO
U100
Liquid meal
0.2 U/kg insulin
AUC0-1h: +52%* AUC0-2h:
Insulin exposure Post-Prandial Glucose
Trial in 38 subjects with type 1 diabetes (NCT#02213146) ; *CI-95% for LSM ratio
-61%*
JUNE 7, 2016 14
Ultra-rapid concentrated BC Lispro U200 displays bioequivalent profile
BC LISPRO
U200
BC Lispro U200 met FDA-defined criteria for
bioequivalence
Both U100 & U200 dossiers could be filed
simultaneously
$10M milestone payment from Lilly (Dec. 2015)
BC Lispro U200 could be the 1st ultra-rapid
prandial concentrated insulin
Serum Insulin
Trial in 26 healthy volunteers (NCT#02529293)
JUNE 7, 2016 15
Ongoing pre-Phase 3 program, in partnership with Lilly, aims to document BC Lispro U100 performance in different diabetic populations:
Repeated administration in T1D – successfully completed (March 14, 2016)
Repeated administration in T2D – successfully completed (April 27, 2016)
Study in Japanese healthy subjects – successfully completed (May 31, 2016)
Insulin pump therapy in T1D – Results expected Q3 2016
Lilly has announced potential phase 3 initiation of ultra-rapid insulin in 2016
BC Lispro clinical program BC LISPRO
HINSBET: A BETTER HUMAN INSULIN COST-EFFECTIVE RAPID ACTING INSULIN
JUNE 7, 2016 16
JUNE 7, 2016 17
HinsBet: A cost-effective prandial treatment option for everyone, everywhere
HINSBET
HinsBet U100
HinsBet U500
HINSBET
Dosing closer to mealtime
Lower injection volumes with closer to mealtime dosing
Cost-effectiveness of human insulin
JUNE 7, 2016 18
HinsBet could be a cost-effective alternative to prandial insulin analogs
HINSBET
Ongoing Meal Test Study
36 people with T1D
Results expected Q3 16
Early Glucose Infusion Rate (U100)
Trial in 36 subjects with type 1 diabetes (NCT#02213146).
BIOCHAPERONE COMBO AN IMPROVED ALTERNATIVE TO PREMIX
JUNE 7, 2016 19
JUNE 7, 2016 20
BC Combo: A true combination of two gold standard insulins - Glargine as basal and Lispro as prandial
BC COMBO
Lispro Humalog®
Glargine Lantus®
BioChaperone Combo
6 10 14 18 22 2 6 6 10 14 18 22 2 6
6 10 14 18 22 2 6 6 10 14 18 22 2 6
Once-a-day
Twice-a-day
6 10 14 18 22 2 6
vs. Premix insulin
Twice-a-day
JUNE 7, 2016 21
BC Combo: Achieving strong basal and prandial control in a simple two-in-one option
BC COMBO
BIOCHAPERONE COMBO
Simple regimen with better PPG
and FPG than premix
Similar control with fewer
injections than basal +1
Less risk of hypoglycemia as a QD or BID
regimen
JUNE 7, 2016 22
BC Combo: Better post-meal glucose control compared to Humalog® Mix75/25TM in type 1 diabetes
BC COMBO
T1DM
Post-Prandial Blood Glucose in T1D4 (meal test)
Glucose Infusion Rate in T1D (clamp)1
AUC0-2h: +58%2
AUC12-30h: +57%3
1Trial in 20 people with T1D (NCT#01981031); 2 p=10-3;3 p=0,025 4Trial in 28 people with T1D (NCT#02514954); 5 p=3.10-3;6 p=8.10-3
BGmin: +30%6
Individualized doses
Delta AUC0-2h : -24%5
Faster
Longer
JUNE 7, 2016 23
BC Combo confirmed its excellent profile in people with type 2 diabetes
BC COMBO
T2DM
1Trial in 24 people with T2D (NCT#02514850); 2 p=10-4;3 p=0,0105 ; 4 p= 0. 5227 ; 5 p= 0.6747 ; 0.8 U/kg (0.2 prandial+0.6 basal)
AUC0-2h: +XX%2
AUC24-30h: +XX%3
Same AUC0-2h4
Glucose infusion rate Glucose infusion rate
AUC 0-2h: +65%1
JUNE 7, 2016 24
Two studies will be launched Q3 16. Results expected Q1 2017
Confirm improved post-prandial glucose control in people with T2D: Meal Test study vs. Premix and Basal Insulin
Demonstrate full-day coverage at steady-state in people with T2D
Simplified development plan relying on existing data for glargine and lispro
Preparation of meetings: pre-IND (FDA) & scientific advice (EMA) to validate the development plan
Adocia intends to consolidate BC Combo’s promising product profile to prepare for Phase 3
BC COMBO
BIOCHAPERONE PDGF A CONVENIENT SPRAY FOR DFU
JUNE 7, 2016 25
>50% Rate of
reoccurrence at 3 years2
JUNE 7, 2016 26
Diabetic foot ulcer: A devastating disease BC PDGF-BB
15% of diabetic patients will develop a DFU1
1M amputations
each year1
Chronic hyperglycemia leads to neuropathy and ischemia, which both contribute to the risk of diabetic foot ulcer
Standard of care is established, but unsatisfactory
Debridement, off-loading, infection management, moisturizing
Further therapeutic interventions remain questionable
Regranex (PDGF-BB) was the only approved biologic product in US & Europe, but with a limited uptake
1Wounds Internationnal 2013, 2 Boulton JM, Diabetes Microvascular Complications Today, 2006
JUNE 7, 2016 27
BC PDGF-BB: A cost-effective first-line treatment for diabetic foot ulcer
BC PDGF-BB
Easy to use and convenient
Applied once every two days
Ready-to-use spray
Sterile without preservatives
Multi-uses for 6 weeks
Stable up to 3 mo. at 30°C / 30 mo. at 5°C
Cost effective
1/3 of PDGF dosage vs. Regranex®
Reduced cost of treatment due to reduced dosage and frequency of application
Phase I/II study (India)
Incidence of complete wound closure after 20 weeks of treatment
79%
38/48 66%
31/47
Regranex BC PDGF-BB
Trial in 192 patients with a DFU (neuropathic or neuroischemic), NCT#01098357
JUNE 7, 2016 28
BC PDGF-BB: A dual development pathway BC PDGF-BB
Positive Phase 1/2 INDIA
DFU
Ongoing Phase 3 INDIA
Phase 3 USA
Planned H1 2017
Phase 3 EUROPE
Planned H1 2017
Results Q3 16
EMA-validated short development
Seek approval INDIA + 10 countries
(Asia, S. America, Africa)
Completed
Ongoing
Planned
WHO-GMP PDGF
cGMP PDGF
Go/No Go decision
BC GLUCAGON A STABLE SOLUTION OF GLUCAGON
JUNE 7, 2016 29
JUNE 7, 2016 30
Insulin and glucagon are the main antagonist hormones regulating blood glucose levels
DIABETES
Blo
od
glu
cose
co
nce
ntr
atio
n
INSULIN
HYPERGLYCEMIA
HYPOGLYCEMIA
GLUCAGON
JUNE 7, 2016 31
Stable liquid glucagon is needed to address different hypoglycemia-related indications
BC GLUCAGON
BIOCHAPERONE GLUCAGON
Stable and soluble at ph7
Ready-to-use
prefilled pen
Hypoglycemia Rescue
Dual Hormone Artificial Pancreas
Congenital hyperinsulinism
Orphan disease
Chronic
hypoglycemia
JUNE 7, 2016 32
BC Glucagon: Preliminary preclinical results and development plans
BC GLUCAGON
BC Glucagon is soluble and stable at pH 7
Preliminary preclinical data shows similar PD performance to commercial glucagon
First-in-man study expected to start H1 17
Preclinical study in 12 farm pigs. Fasted animals were injected with octreotide to inhibit endogenous glucagon production. Glucagen resonstituted ex-temporane
Change in blood glucose
Key financial elements FINANCE
Shareholders’ equity
Listed on Euronext Paris (ADOC)
6.8M shares outstanding
ADR program in the US (ADOCY)
Market Cap €400M (June 01, 2016)
Well capitalized €64.2M cash position (March 31, 2016)
€80M raised since inception
Long term debt:
€0.9M loan from BPI France (refundable in case of success)
€5.9M bank loan for purchase of Lyon headquarters building
Analysts
Bryan, Garnier & Co (Eric Le Berrigaud) Kepler Market (Arsène Guekam) Invest Securities (Martial Descoutures) Leerink (Seamus Fernandez) Jefferies (Peter Welford) Oddo (Sébatien Malafosse – Pierre Corby)
Corporate facts
Founded in 2005 by Gérard, Olivier & Rémi Soula
Headquartered in Lyon, France
US subsidiary
120 employees, 44PhDs
Financial summary
33
JUNE 7, 2016 34
INSULIN
BC LISPRO
Ongoing Phase 2a CSII results : Q3 16
Lilly has announced potential phase 3 initiation of ultra-rapid insulin in 2016
$270M in potential remaining development milestones
BC COMBO
2 new Phase 2a planned in T2D: Q1 17
HINSBET
Ongoing Phase 2a study results: Q3 16
Upcoming catalysts ADOCIA
NON-INSULIN
BC PDGF
Ongoing Indian Phase 3 results: Q3 16
BC GLUCAGON
First-in-man study planned: Q1 17
JUNE 7, 2016 35
Specialists in protein-based diabetes treatments
Low-risk business model – Biochaperone platform enhances already approved proteins to create new therapeutic options and new markets
Eli Lilly partnership provides near term milestones and revenues
Strong pipeline with multiple Phase II and Phase III trial results expected in 2016
Proven management team with successful track record
Well capitalized with €64M in cash
ADOCIA in summary SUMMARY
ADOCIA 115 avenue Lacassagne 69003 Lyon – France Tel +33 4 72 610 610 contact@adocia.com
THANK YOU FOR YOUR KIND INTEREST
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