through long-acting injectables · • lead product in phase iii with partner • large scale gmp...

21
BUILDING A GLOBAL PHARMA LEADER Through Long-Acting Injectables Corporate Presentation - January 2019

Upload: others

Post on 23-Mar-2020

3 views

Category:

Documents


1 download

TRANSCRIPT

Page 1: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P1 •© M

edin

Cel

l-Ja

nuar

y 20

19

BUILDING A GLOBAL PHARMA LEADER Through Long-Acting InjectablesCorporate Presentation - January 2019

Page 2: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P2 •© M

edin

Cel

l-Ja

nuar

y 20

19

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.

The Information is delivered to you on the basis of your compliance with the legal and regulatory obligations to which you are subject.Copies of this document must be returned at the end of the meeting. This document may not be removed from the premises.If this document has been received in error, it must be immediately returned, along with any other copies, to the Company. The Information is made available on a confidential basis, to a limited number of recipients solely for the purposes of preliminary discussions regarding a potential initialpublic offering of the Company (the “Proposed Transaction”). The Information, including this presentation and its contents, has not been verified by Bryan Garnier or Crédit Agricole CIB (the “Banks”), or any of their affiliates, shareholders, directors, officers, advisers, employees andrepresentatives or otherwise independently verified.

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.

The Information does not constitute or form part of a prospectus or any offer or invitation for the sale or issue of, or any offer or inducement to purchase or subscribe for, or any solicitation of any offer to purchase or subscribe for any shares or other securities in the Company in France, theUnited Kingdom, the United States or any other jurisdiction. It does not constitute any form of commitment on the part of the Company or any other person. Neither the Information nor any other written or oral information made available to any recipient or its advisers will form the basis ofany contract or commitment whatsoever. In particular, in furnishing the Information, the Company, the Banks, their affiliates, shareholders, directors, officers, advisers employees or representatives undertake no obligation to provide the recipient with access to any additional information. Inthe European Economic Area (“EEA”) the Information is only addressed to and directed at persons in member states who are “qualified investors” within the meaning of Article 2(1)(e) of the Prospectus Directive (Directive 2003/71/EC) (“Qualified Investors”).Within the United Kingdom, the Information is intended for distribution only to persons who are Qualified Investors who (i) have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order2005, as amended (the “Order”) or (ii) are persons falling within Article 49(2)(a) to (d) (“high net worth companies, unincorporated associations, etc.”) of the Order or (iii) are persons to whom it may otherwise lawfully be communicated (all such persons together being referred to as“relevant persons”) and in such a case any investment or investment activity to which the Information relates is available only to relevant persons and will be engaged in only with relevant persons.Securities may not be offered, subscribed or sold in the United States absent registration under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), except pursuant to an exemption from, or in a transaction not subject to, the registration requirements thereof. Thesecurities of the Company have not been and will not be registered under the U.S. Securities Act and the Company does not intend to make a public offer of its securities in the United States. Neither this document nor any copy of it may be taken or transmitted into, directly or indirectly, intothe United States, other than to “qualified institutional buyers”, within the meaning of Rule 144A under the Securities Act.

Neither this document nor any copy of it may be taken or transmitted into Australia, Canada or Japan or to any person in any of those jurisdictions.

Page 3: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P3 •© M

edin

Cel

l-Ja

nuar

y 20

19

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

P3 •

Page 4: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P4 •© M

edin

Cel

l-Ja

nuar

y 20

19

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

Page 5: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P5 •© M

edin

Cel

l-Ja

nuar

y 20

19

LAIs ENGINE ALLOWS FOR FAST PORTFOLIO GROWTH

Objective: at least 1 IND / Year

P5 •

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

Page 6: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P6 •© M

edin

Cel

l-Ja

nuar

y 20

19

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…

Page 7: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P7 •© M

edin

Cel

l-Ja

nuar

y 20

19

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

Page 8: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P8 •© M

edin

Cel

l-Ja

nuar

y 20

19

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

Page 9: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P9 •© M

edin

Cel

l-Ja

nuar

y 20

19

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

Page 10: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P10 •© M

edin

Cel

l-Ja

nuar

y 20

19

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

Page 11: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P11© M

edin

Cel

l-Ja

nuar

y 20

19

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

Page 12: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P12© M

edin

Cel

l-Ja

nuar

y 20

19

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

Page 13: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P13© M

edin

Cel

l-Ja

nuar

y 20

19

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)

Page 14: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P14© M

edin

Cel

l-Ja

nuar

y 20

19

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

Page 15: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P15© M

edin

Cel

l-Ja

nuar

y 20

19

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

Page 16: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P16© M

edin

Cel

l-Ja

nuar

y 20

19

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%

Page 17: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P17© M

edin

Cel

l-Ja

nuar

y 20

19

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%

Page 18: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P18© M

edin

Cel

l-Ja

nuar

y 20

19

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

Page 19: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P19© M

edin

Cel

l-Ja

nuar

y 20

19

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

Page 20: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P20© M

edin

Cel

l-Ja

nuar

y 20

19

> 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)

Page 21: Through Long-Acting Injectables · • Lead product in Phase III with partner • Large scale GMP polymer availability LAIs Engine • 2 products in clinical studies, 1 in non-clinical

P21© M

edin

Cel

l-Ja

nuar

y 20

19

€ 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%

P21 •

*Anh Nguyen, Chairman of MedinCell

Market Cap: c.$ 150m

outstanding shares: 20.1m

ISIN: FR0004065605