through long-acting injectables · • lead product in phase iii with partner • large scale gmp...
TRANSCRIPT
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BUILDING A GLOBAL PHARMA LEADER Through Long-Acting InjectablesCorporate Presentation - January 2019
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IMPORTANT NOTICE - YOU MUST READ THE FOLLOWING BEFORE CONTINUINGThe following applies to this document, the oral presentation of the information in this document by Medincell S.A. (the “Company”) or any person on behalf of the Company and any question-and-answer session that follows the oral presentation (collectively, the “Information”).We remind you that you have agreed, prior to being granted access to the Information, that: (i) you will not disclose the Information to anyone within your firm (other than and subject to the restrictions you have agreed to when your firm was initially contacted) oroutside your firm, and (ii) these restrictions will apply to your entire firm. By attending the meeting where this presentation is made, or by reading this document, you further agree to be bound by the following limitations and qualifications. Failure to comply with thesemay constitute a violation of applicable securities laws.
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Some of the financial information contained in this document has been prepared in accordance with French GAAP. French GAAP differ from International Financial Reporting Standards (IFRS); related financial information is therefore not directly comparable. In addition, some of the financialinformation contained in this document is not directly extracted from the Company’s accounting systems or records and is not IFRS accounting measures; it has not been independently reviewed or verified by the Company’s auditors or by the Banks.The market data and certain industry forecasts included in this document were obtained from internal surveys, estimates, reports and studies, where appropriate, as well as external market research, publicly available information and industry publications. The Company, the Banks, theiraffiliates, shareholders, directors, officers, advisors, employees and representatives have not independently verified the accuracy of any such market data and industry. Such data and forecasts are included herein for information purposes only.This document contains certain statements that are forward-looking. These statements refer in particular to the Company management’s business strategies, its expansion and growth of operations, future events, trends or objectives and expectations, which are naturally subject to risks andcontingencies that may lead to actual results materially differing from those explicitly or implicitly included in these statements. The Company does not undertake to update or revise the forward-looking statements that may be presented in this document to reflect new information, futureevents or for any other reason and any opinion expressed in this presentation is subject to change without notice.No representation or warranty, express or implied, is made as to, and no reliance should be placed upon, the fairness, accuracy, completeness or correctness of the Information and none of the Company, the Banks, their affiliates, shareholders, directors, advisors,employees and representatives accept any responsibility in this respect.The Information does not constitute a recommendation regarding the Proposed Transaction and does not purport to contain all information that may be required to evaluate the Proposed Transaction. The merit and suitability of an investment in the Company should be independentlyevaluated and any person considering such an investment in the Company is advised to obtain independent advice as to the legal, tax, accounting, financial, credit and other related advice prior to making an investment. Investors should not subscribe for or purchase any securities of theCompany except on the basis of information in a final form prospectus that may be published by the Company, which would supersede this presentation in its entirety and would contain a description of risk factors pertaining to the Company, its businesses and such an investment. Inaccepting the Information the recipient acknowledges that it makes all trading and investment decisions in reliance on its own judgment and not in reliance on any of the Company, the Banks, their affiliates, shareholders, directors, officers, advisers, employees or representatives.The Banks are acting solely for the Company in connection with the Proposed Transaction and no one else. They will not regard any other person (whether or not a recipient of the Information) as a client in relation to the Proposed Transaction and, accordingly, will not be responsible to anyother person for providing the protections afforded to their respective clients, or for advising any such person in relation to the contents of the Information or in connection with the Proposed Transaction.
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INVESTMENT HIGHLIGHTS
Clinically validated Long-Acting Injectable (LAI) technology BEPO®
• Lead product in Phase III with partner
• Large scale GMP polymer availability
LAIs Engine • 2 products in clinical studies, 1 in non-clinicaland 7 in formulation research, adding new ones constantly
• Multiple therapeutic areas (CNS, pain, women’s health, organ transplant, etc.)
• Large scale development of Long-Acting Injectables
Network company • Partners: Teva Pharmaceuticals, Bill & Melinda Gates Foundation, Corbion, Arthritis Innovation Corporation (AIC) with either milestones + royalties or 50/50 profit sharing
• Developing proprietary portfolio
Strong cash position • €16m cash and non-risky assets as of Sept 30, 2018
• € 31.4m IPO (gross proceeds) completed in October 2018
• €20.0m long term loan from European Investment Bank (€12.5m not drawn as of Dec 31, 2018)
People based model • 130 people, all shareholders
• 30 nationalities
Listed on Euronext Paris Ticker: MEDCL - ISIN: FR0004065605
Market Cap: c.$ 150m
Outstanding shares: 20.1m
Headquarter: Jacou, France
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ALREADY THREE PROGRAMS IN NON-CLINICAL & CLINICAL
FORMULATION RESEARCH
AS OF SEPTEMBER 30, 2018
NON CLINICAL CLINICAL PHASE I CLINICAL PHASE II CLINICAL PHASE III MARKETIND1 NDA2
PHASE II EXEMPTED3
PHASE I EXEMPTED3
mdc-WWM mdc-ANGSCHIZOPHRENIA
mdc-CMVANESTHESIA, PAIN
mdc-GRTTRANSPLANT
mdc-NVAPAIN
mdc-DOMMEN’S HEALTH
mdc-ELKDEPRESSION
mdc-IRM
US Phase III • Start July 2018
SCHIZOPHRENIAPartner: TevaCONTRACEPTION
Partner:Bill & Melinda Gates Foundation
mdc-TJK
Non Clinical • Start March 2018
SCHIZOPHRENIAPartner: Teva
Partnered
mdc-CWM
US Phase II • Start May 2018
PAIN & INFLAMATIONPartner: AIC4
1. Investigational New Drug2. New Drug Application3. Products based on already approved Active Pharmaceutical Ingredients can benefit from accelerated regulatory pathways such as the 505(b)(2) in the US4. Arthritis Innovation Corporation (AIC): Company founded by North American physicians & entrepreneurs
ORGAN TRANSPLANT
UROLOGY
CNS
CNS
PAIN & INFLAMMATION
US Phase III • Start June 2018
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LAIs ENGINE ALLOWS FOR FAST PORTFOLIO GROWTH
Objective: at least 1 IND / Year
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2
43
5
7
Dec-14 Dec-15 Dec-16 Dec-17 Dec-18
Number of programs and stage
Formulation Non-clinical Phase 1/2 Phase 3
Development
2
2
3
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PRODUCT 2019 2020
mdc-IRM (TV-46000)SchizophreniaAPI: risperidone
> Start of US Phase III June 2018 ▸
mdc-TJKCNSAPI: confidential
> Start of non-clinicalMarch 2018 ▸
mdc-ANGCNSAPI: confidential
▸mdc-CWMPain and inflammationAPI: celecoxib
> Start of US Phase II May 2018 ▸
mdc-CMVAnesthesia and painAPI: ropivacaine
▸mdc-NVAPainAPI: ropivacaine
▸mdc-WWMContraceptionAPI: progestin
> BMGF grantDec 2017 ▸
US Phase III interim data
US Phase III results
Start of US Phase I
Start of non-clinical
Start of Phase I
US Phase IIresults
Start of US Phase IIb
Start of non-clinical
Start of Phase I/II
Start of non-clinical
Start of non-clinical
JPM 2019
UPCOMING DEVELOPMENT NEWSFLOW> MULTIPLE PRODUCTS X MULTIPLE MILESTONES Note: does not include other news flow such as new partners, etc…
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Formulation
Each formulation contains
• PEG/PLA polymers customized for each indication
• Hydrophilic solvent
• Active Pharmaceutical Ingredient
Subcutaneous or local injection
In situ depot precipitates immediately after subcutaneous or local injection
Controlled release
API is safely released as depot fully degrades
BEPO®: LAI CUTTING EDGE POLYMER TECHNOLOGY
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THERAPEUTIC LEVEL
DR
UG
LEV
EL
TIME
TOXICITY LEVEL
LAIControlled and customized release for days, weeks or months
Time impact > known API in same indication
Space impact > known API in new indication
WE APPLY OUR LAI TECHNOLOGY BEPO®
TO ALREADY KNOWN APIsMAKING DRUGS EFFICIENT
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WE APPLY OUR LAI TECHNOLOGY BEPO®
TO ALREADY KNOWN APIsMAKING DRUGS EFFICIENT
Attractive risk / return profile
Simpler regulatory pathways e.g. US 505(b)(2)
Significantly less financial resources needed
Significantly less risk in clinical phases especially when same indication
HIGH
LOWLOW
HIGH
RET
UR
N
SUCCESS RATE
GENERIC
NCE(New Chemical Entity)
LAIs with approved APIs
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WE APPLY OUR LAI TECHNOLOGY BEPO®
TO ALREADY KNOWN APIsMAKING DRUGS EFFICIENT
Time impact: adherence Release profile
Additional Efficacy
and / or
API efficacy + LAI primary benefits + LAI potential benefits + Affordability = Efficiency
Space impact: local treatment
Fast development
Low COGS
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mdc-IRM: 1 & 2-MONTH SUBCUTANEOUS RISPERIDONE > SCHIZOPHRENIA: A CHRONIC PSYCHOSIS AFFECTING AT LEAST 23M PEOPLE WW
Cost of schizophrenia in the US: Between $134bn and $174bn $38bn for excess direct health care costsHospital inpatient treatment, outpatient and emergency department visits, medications
$9bn for direct non–health care costsLaw enforcement, incarceration, homeless shelters
$117bn for indirect costsUnemployment, lost productivity, premature mortality
AN EXTREMELY DEBILITATING DISEASE
POSITIVE SYMPTOMSHallucinations Disorganized speechDelusions
NEGATIVE SYMPTOMSFlat affect Poverty of speech
COGNITIVE SYMPTOMSAttentionMemory Executive functions
50% of schizophrenic patients do not take their treatments correctly
Analysis Group, Otsuka, Lundbeck LLC - 2016
Lacro JP, Dunn LB, Dolder CR, Leckband SG, Jeste DV. Prevalence of and risk factors for medication nonadherence in patients with schizophrenia: a comprehensive review of recent literature. J ClinPsychiatry. 2002;63:892–909
Source: NCBI – World Psycharty, Oct. 2017
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mdc-IRM: 1 & 2-MONTH SUBCUTANEOUS RISPERIDONE > ANTIPSYCHOTICS LAIs: A $ 4.4Bn MARKET GROWING +21% CAGR
Source: IMS Sales date, Midas & Globaldata, (1) Atypical Antipsychotics, (2) Conventional Antipsychotics
GLOBAL ANTIPSYCHOTIC SALES (in 7MM in $bn)
1.7 2.1 2.5 3.0 3.7 4.4
15.914.8
17.0 16.4
13.312.5
2012 2013 2014 2015 2016 2017LAI Oral Total
5-year LAIs CAGR
21%
2012 2013 2014 2015 2016 2017US EUR Japan
1.72.1
3.0
3.7
2.4
4.4
LAI ANTIPSYCHOTIC SALES ($bn)
USA is largest market: 75% of sales
Fastest Growth (+27% CAGR)
ANTIPSYCHOTICS MARKET SHARE BY CLASS / FORM
LAIs account for only
10%
2005 2007 2009 2011 2013 2015 20160%
10%
20%
30%
40%
50%
60%
70%
80%
AAP oral AAP LAICAP oral CAP LAI
(1) (1)
(2) (2)
TotalTotal
Total
Total
Total
Total
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mdc-IRM: 1 & 2-MONTH SUBCUTANEOUS RISPERIDONE > TEVA & MEDINCELL COLLABORATION
Focus on CNS “We are developing a focused pipeline of new drugs and novel treatments to meet patient and societal needs in a range of CNS conditions.” TEVA Website
Strong US presence(c. 50% revenue)
US market represents c. 75% of antipsychotics market
R&D spanning both novel and generic compounds
Significant investment from TEVA since 2014 to support MedinCell’s development
Collaboration with MedinCell
3 products in CNS
All development costs covered by TEVA
MedinCell to receive> Development and commercial milestones of up to $122m for each product ($366m total)> Royalties on sales
Renewed commitment by new TEVA team after full R&D portfolio rationalization (Q1 2018)
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mdc-IRM: 1 & 2-MONTH SUBCUTANEOUS RISPERIDONE > A COMPELLING VALUE FOR UNMET MEDICAL NEEDS IN SCHIZOPHRENIA
PRODUCT STATUS DURATION> 2 MONTHS
SUBCUTANEOUS IMMEDIATE ONSET
EASE OF USE NEEDLE SIZE 2017 SALES
RISPERDAL CONSTA®
RisperidoneMarketed ✘
2 weeks✘
Intramuscular✘ ✘
Complex reconstitution
✓21G
$ 3.4BnINVEGA SUSTENNA® / XEPLION®
Paliperidone
Marketed ✓1 and 3 months
✘Intramuscular ✓ ✓
Ready-to-use✓23G
PERSERIS™ Risperidone
FDA approved ✘1 month ✓ ✓ ✘
Complex reconstitution
✘18G
N/A
mdc-IRM (TV-46000)Risperidone
US Phase III ✓1 and 2 months
✓ ✓ ✓Ready-to-Use
✓Not
disclosed
N/A
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mdc-IRM: 1 & 2-MONTH SUBCUTANEOUS RISPERIDONE > PHASE III STUDY DESIGN, INITIATED JUNE 2018 (TV-46000)
TYPE DESIGN POPULATION COUNTRY, CENTERS AND PERIOD ENDPOINTS
PHASE III Multicenter, double-blind, randomized, relapse prevention study comparing in a 1:1:1 ratio: • A therapeutic dose of mdc-IRM
every month (Q1M) • A therapeutic dose of mdc-IRM
every 2 months (Q2M)• Placebo (Q1M)
Evaluate the efficacy, safety and tolerability of extended-release injectable suspension mdc-IRM for subcutaneous use as maintenance treatment
596 male and female patients, 18 to 65 years of age, who have a confirmed diagnosis of schizophrenia, are clinical stable, and are eligible for risperidone treatment
Randomization: 1:1:1
Country: United-States,Bulgaria
Center(s): 80 (est.)
Interim results: H2 2019
Final results:H1 2020
Primary endpoint: median time to impending relapse
Secondary endpoints:• Impending relapse rate at week 24
(Kaplan-Meier method)• Observed rate of impending relapse• Percentage of patients who maintain
stability• Percentage of patients achieving
remission
Study will conclude on observation of 207 events (impending relapses) Study may conclude on observation of 125 events (impending relapse) if statistically significant
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mdc-IRM: 1 & 2-MONTH SUBCUTANEOUS RISPERIDONE > BUILDING AN INNOVATIVE PORTFOLIO OF SCHIZOPHRENIA LAIs TO ADRESS
LARGE MARKET POTENTIAL
Source: IMS Sales data, Midas & Globaldata, MedinCell (7MM)
mdc-IRM ▻ Best-in-class LAI▻ Capture market shares & extend market 2 other products in formulation research / development
Ar ipiprazole Olanzapine Quetiapine Clozapine Lurasidone Others
LAI Oral
1.1
0.9
0.5
0.20.2 0.2
ALL ANTIPSYCHOTICS (Treated patients)
OTHER ANTIPSYCHOTICS(Treated patients)
0.08
mdc-IRM
Risperidone +
Paliperidone
1.8MOther
antipsychotics
3.0M
LAI: 24%
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mdc-CWM: INTRA-ARTICULAR CELECOXIB INJECTION> TOTAL KNEE SURGERY POST-OPERATIVE PAIN AND INFLAMMATION
TREATMENT MARKET NOT PROPERLY ADRESSED BY OPIOIDS
Source: (1) S. N. Williams, M. L. Wolford, A. Bercovitz, Hospitalization for Total Knee Replacement Among Inpatients Aged 45 and Over: United States, 2000-2010. NCHS Data Brief, 1-8 (2015) ; (2) S. M. Kurtz et al., Future clinical and economic impact of revision total hip and knee arthroplasty. The Journal of bone and joint surgery. American volume 89 Suppl 3, 144- 151 (2007) ; (3) Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: Results from a US national survey. Curr Med Res Opin. 2014;30(1):149-160; (4) Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: Opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013;33(4):383-391
UNSATISFAYING POST-SURGERY TREATMENTSignificant pain for two weeks and reduced but continued pain for 6-12 weeks post surgeryContra-indication of traditional oral anti-inflammatory products post surgeryEffectiveness of current practices for postoperative pain management remains limited: 57% to 73%(3) of operated patients report moderate to extreme postoperative pain, leading to longer hospitalization stay, revision surgery, disability leave etc.
OPIOIDS EPIDEMIC ISSUE The use of opioids in the treatment of postoperative pain is globally widespread and particularly in the US: c. 90% of operated patients(3)
Negative side effects observed in 96% of operated patients, increasing the duration of hospitalization in 55% of cases(4)
91 people die every day in the US because of opioids overdose according to the Centers for Disease Control and Prevention
0.7M
2010(1)
NUMBER OF TKR PROCEDURES IN THE US > A STRONG MARKET OPPORTUNITY
3.5M
2030 forecast(2)
CAGR: 8%
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mdc-CWM: INTRA-ARTICULAR CELECOXIB INJECTION> TOTAL KNEE SURGERY POST-OPERATIVE PAIN AND INFLAMMATION
TREATMENT A REVOLUTIONARY APPROACH ENABLED BY BEPO®
PGE2 concentration in the synovial fluid with and without mdc-CWM
0
500
1 000
1 500
2 000
2 500
0 30 60 90
PG
E2 (
pg/
ml)
Time (days)
Controlmdc-CWM
Data represents means, Day 0, n=35, Day 7, n=5, 4 for F14, Control; Day 30 & 90, n=5
Pre-clinical in vivo tests demonstrated efficacy, reducing PGE2 concentration for up to 90 days
Product Intra articular (knee) celecoxib long acting injectable
Molecule Celecoxib, approved by the FDA in the pain treatment in 1998 often used in the treatment of acute pain, rheumatoid arthritis, ankylosing spondylitis etc.
Duration Up to 6 weeks
Mechanism of action One-time local delivery for the control of post-total knee replacement pain and inflammation through sustained release of Celecoxib in the intraarticular space, with improved safety (Better cardio and gastrointestinal-toxicity profiles)
Little to no systemic exposure avoids risk of adverse NSAID issues
AIC Collaboration AIC: Arthritis Innovation Corporation: Company founded by NorthAmerican physicians & entrepreneurs
All development costs borne by AIC
50-50 profit sharing
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mdc-CWM: INTRA-ARTICULAR CELECOXIB INJECTION> TOTAL KNEE SURGERY POST-OPERATIVE PAIN AND INFLAMMATION
TREATMENT PHASE II STUDY DESIGN, INITIATED MAY 2018
TYPE DESIGN POPULATION COUNTRY, CENTERS AND PERIOD
ENDPOINTS
PHASE II Randomized, single-blind, active-control, parallel group (with randomized 1:1) study to evaluate the safety and activity of a single administration of mdc-CWM for management of postoperative pain in participants undergoing unilateral total knee replacement
50 subjects Country: USA (Rockville)
Center: 1
Final results:Summer 2019
Key efficacy outcomes of the study include:
Peak pain intensity (VAS) at 2 weeks
Pain intensity calculated using area under the curve (AUC) and summed pain intensity difference (SPID) from 0-72 hours (using measurements from 12, 24, 48, 72 hours)
Functional improvement by Timed Up and Go test at 1, 2, 3 and 6 weeks, and 3 months
Total postsurgical opioid consumption (in MSO4 equivalents) up to 3 months
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> ILLUSTRATION: COLLABORATION WITH BILL & MELINDA GATES FOUNDATION IN LONG ACTING CONTRACEPTIVE
• May be 1st program developed for humanitarian purposes to reach developed countries
• High potential in developed countries
> COMPLIANCE & ACCESS ARE KEY ISSUES IN DEVELOPING WORLD
• WHO estimates that one patient in two does not start or does not continue to follow their treatment and that adherence improvement would have a greater impact than any improvement in specific medical treatments1
• LAI can impact both compliance and access issues
> AFFORDABILITY SHOULD ALLOW TO TAP PROFITABILITY RESERVOIR ON DEVELOPING COUNTRIES
• Low COGS technology
• Aiming to lower development costs with approved API’s
WE PROVIDE AN ANSWER TO GLOBAL HEALTH CHALLENGES
1 World Health Organization: Adherence to Long-Term Therapies, Evidence for Actions (2003)
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€ million 6-month period 6-month periodSept 30, 2018 Sept 30, 2017
Revenue 1.8 2.7
Operating result (6.6) (4.1)
Net result (9.8) (4.9)
Earning per share (€) (0.68) (0.34)
Cash position 11.4* 4.3**
* not including € 4.6m of non-risky financial assets and proceeds from the IPO completed in October 2018 (€ 31.4m gross proceeds)
** not including € 4.5m of non-risky financial assets
KEY FINANCIALS
Nguyen Family*21%
Top Management
15%
Employees12%
CM-CIC, Seventures, BNP Paribas
19%Teva4%
Former employees, Consultants and Affiliate
19%
Other10%
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*Anh Nguyen, Chairman of MedinCell
Market Cap: c.$ 150m
outstanding shares: 20.1m
ISIN: FR0004065605