through long-acting injectables · mdc-irm (tv-46000) schizophrenia api: risperidone > start of...

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BUILDING A GLOBAL PHARMA LEADER Through Long-Acting InjectablesCorporate Presentation - September 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.

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.

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INVESTMENT HIGHLIGHTS

Clinically validated Long-Acting Injectable (LAI) technology BEPO®

• Lead product in Phase 3 with partner

• Large scale GMP polymer availability

LAIs Engine • Human Health: 3 products in clinical studies, 2 in preclinicaland 4 in formulation research, adding new ones constantly

• Multiple therapeutic areas (CNS, pain, women’s health, organ transplant, etc.)

• Animal Health: first active programs

• 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 positionas of March 31, 21019

• 21,3 M€ in cash and cash equivalents

• 0,7 M€ in short-term investments+ 3,9 M€ in non-current financial assets

• 12.5 M€ drawable from the European Investment Bank loan

People based model • 124 people, all shareholders

• 22 nationalities

Listed on Euronext Paris Ticker: MEDCL - ISIN: FR0004065605

Market Cap: c.$ 155 M

Outstanding shares: 20.1 M

Headquarter: Jacou, France

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Clinical Phase 3

PORTFOLIO

Preclinical

Clinical Phase 2

IND clearance

Preclinical

Human Health > Already five programs in clinical and preclinical

mdc-IRM • Schizophrenia • Partner: Teva (TV-46000)

mdc-TJK • Central Nervous System • Partner: Teva

mdc-ANG • Central Nervous System • Partner: Teva

mdc-CWM • Pain & inflammation (opioid-free) • Partner: AIC

mdc-CMV • Anesthesia & pain (opioid-free)

mdc-NVA • Chronic pain (opioid-free)

mdc-WWM • Contraception • Supported by the Gates Foundation

mdc-GRT • Transplantation

mdc-DOM • Urology

Animal Health > First program launched through JV with Cornerstone Animal Health

mdc-AH1 • Pain

Programs in lead formulation selection

Animal Health offers an attractive risk profile as the products can be tested in the target species during the lead formulation selection. Development times are significantly shorter and funding requirements may be one order of magnitude lower compared to human health products.

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LAIs ENGINE ALLOWS FOR FAST PORTFOLIO GROWTH> OBJECTIVE: AT LEAST 1 IND / YEAR

Phase 1 or 2 (P) Preclinal (P)

Phase 1 or 2 (P)

Preclinal (M)

Preclinal (P)

Phase 1 ou 2 (P)

Phase 3 (P)

Preclinical (M)

Preclinical (P)

Phase 1 or 2 (P)

Phase 1 or 2 (P)

Phase 3 (P)

March 31, 2017 March 31, 2018 March 31, 2019 March 31, 2020 (potential)

Human Health programs in development(P) : Partnered program – (M) : MedinCell internal program

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PRODUCT 2019 2020

mdc-IRM (TV-46000)SchizophreniaAPI: risperidone

> Start of US Phase 3 Q2 2018 ▸

mdc-TJKCNSAPI: confidential

> IND clearanceQ3 2018 ▸

mdc-ANGCNSAPI: confidential

> Start of PreclinicalQ3 2019 ▸

mdc-CWMPain and inflammationAPI: celecoxib

> Start of US Phase 2 May 2018 ▸

mdc-CMVAnesthesia and painAPI: ropivacaine

> Start of PreclinicalMarch 2019 ▸

mdc-NVAPainAPI: ropivacaine

▸mdc-WWMContraceptionAPI: progestin

> BMGF grantDec 2017 - Jan 2019 ▸

mdc-GRTOrgan transplantAPI: tacrolimus

▸mdc-AH1Pain - PetsAPI: confidential

▸

Phase 3 completion

H1 2020

UPCOMING DEVELOPMENT NEWSFLOW> MULTIPLE PRODUCTS X MULTIPLE MILESTONES Note: does not include other news flow such as new partners, etc…

Start of Phase 1H2 2019

Go toUS Phase 3Q4 2020

Phase 2interim dataSummer 2019

Phase 2CompletionApril 2020

Start of Phase 1 / 2Q2 2020

Start of preclinicalQ3 2020

Second GrantQ3 2019



IND clearanceH1 2020

Start of Phase 1H2 2020

Start of regulatory development

H2 2020

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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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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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Time impact: adherence Release profile

Additional Efficacy

Better Safety

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-CMVPERINEURAL ROPIVACAINE INJECTION> First fully-owned program to enter developmentCurrent status: Preclinical Regulatory DevelopmentInitiated March 2019

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mdc-CMV: PERINEURAL ROPIVACAINE INJECTION> CONTROLLED ANESTHESIA + OPIOID FREE 72H ANALGESIA

Opportunity in the US

30M annual Surgical Procedures requiring Postoperative Pain Management

Opioid pain relievers are widely used for postoperative pain management. Negative side effects are observed in 96% of operated patients, increasing the duration of hospitalization in 55% of cases. It is also associated with high risks of abuse, misuse and addiction. On average, 130 Americans die every day from an opioid overdose, according to CDC.

Extended opioid free analgesia could limit chronic pain following a surgery. Every 10% increase in the time spent in severe postoperative pain is associated with a 30% increase in chronic pain 12 months after surgery.

Potential benefits

• Extension and improvement of postoperative pain relief in a wide variety of surgical procedures

• Reduction of risks of chronic pain following a surgery and associated costs

• No need of opioid use for postoperative pain management

• Reduction of duration and costs of hospitalization

• Outpatient treatment

• Simplified act: only one injection combining anesthesia and extended analgesia

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PRODUCT STATUS MOLECULE ANESTHESIAMotor block

ANALGESIAOpium free post op pain management

EXPAREL®

PaciraNasdaq: PCRXMarket cap.: $1.55 B

Marketed2018 Sales : $ 331M

(+17% vs 2017)Bupivacaine

HTX-011Heron TherapeuticNasdaq: HRTX - Market cap.: $2.13 B(2 products already on market)

NDA accepted for Priority Review

Bupivacaine+ Meloxicam

POSIMIR®

DurectNasdaq: DRXX - Market cap.: $130 M(other commercial activities)

NDA Bupivacaine

mdc-CMVMedinCell

Non Clinical& Regulatory Development

Ropivacaine

72h (targeted)

24 to 72h (depending on targeted nerve)Unpredictable

72h+ (targeted)

No

max 6h (target)

mdc-CMV: PERINEURAL ROPIVACAINE INJECTION> A MAJOR STEP FORWARD COMPARED TO EXISTING PRODUCTS & PRACTICES

mdc-CMV will the only product enabling controlled anesthesia and

extended opioid free analgesia with a single injection

For equal efficacy Ropicaine is recognized as a safer agent than Bupivacaine with lower CV and

CNS toxicity and better side-effect profile. Ropicaine is also approved for use in children.

72h (targeted)No

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mdc-CMV: PERINEURAL ROPIVACAINE INJECTION> PROMISING IN VIVO PRECLINICAL RESULTS

1 Mechanical force considered as the analgesic threshold of our validated post-operative pain model

2 Behavior score 3 = motor block effect, the animal can’t stand on the injected leg or the leg is dragging when the animal try to walk

mdc-CMV

Ropivacaine 0.5%

mdc-CMV

Ropivacaine 0.5%

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mdc-IRMSUBCUTANEOUS RISPERIDONECurrent status: US Phase 3 (efficacy, safety and tolerability)Initiated Q2 2018 - 596 patients

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mdc-IRM: 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: SUBCUTANEOUS RISPERIDONE > ATYPICAL ANTIPSYCHOTICS LAIs: A $ 5.2Bn MARKET GROWING +20% CAGR

Global atypical antipsychotics sales $ Bn - 7 MM - 2018

1,7 2,2 2,6 2,9 3,6 4,3 5,2

15,9 15,4

17,416,2

13,312,6

13,5

2012 2013 2014 2015 2016 2017 2018

LAI Oral Total

5-year LAIs CAGR

20%

2012 2013 2014 2015 2016 2017 2018

US EU5 JAPAN

1.72.1

3.0

3.7

2.4

4.4

USA is largest market: 77% of sales

Fastest Growth (+25% CAGR)

89%

11%

Oral LAI

LAIs account for only

11%

LAI atypical antipsychotics sales $ Bn - 7MM - 2018

Global atypicalantipsychotics patients

7MM - 2016

Source: IMS Sales date, Midas & Globaldata

5.2

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TEVA & MEDINCELL COLLABORATION> 3 PRODUCTS IN DEVELOPMENT

R&D spanning already approved 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

Clinical Phase 3

IND clearance

Preclinical

mdc-IRM • Schizophrenia • Partner: Teva (TV-46000)

mdc-TJK • Central Nervous System • Partner: Teva

mdc-ANG • Central Nervous System • Partner: Teva

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mdc-CWMINTRA-ARTICULAR CELECOXIB INJECTIONCurrent status: US Phase 2 (safety and activity)Initiated May 2018 - 20 patients

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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)

130 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 3 months

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 3 months

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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> 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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LATEST NEWS

September 4, 2019

MedinCell receives a new grant from The Bill & Melinda Gates Foundation to develop a best-in-class long-acting injectable product for HIV PrEP

> Read the full story

August 28, 2019

MedinCell partners with Cornerstone to develop a range of best-in-class long-acting injectable veterinary products using BEPO® proprietary technology


August 26, 2019

A second long-acting injectable antipsychotic using MedinCell'stechnology has received FDA IND clearance to initiate clinical activities


July 23, 2019

MedinCell receives the payment of the second tranche of 7,5 M€ from the European Bank of Investment (EIB)


July 9, 2019

MedinCell and Teva have selected a lead formulation for the long-acting injectable mdc-ANG. Preclinical studies are expected to start this quarter


April 5, 2019

MedinCell wins the #LetsgoFrance 2019 trophy in the category “France, a model of sustainable economy”


March 11, 2019

MedinCell demonstrates in vivo the efficacy of the first injectable combining surgical anesthesia and 3 days opioid free postoperative pain management


January 24, 2019

MedinCell receives funding from The Bill & Melinda Gates Foundation for the second formulation phase of its 6-month injectable contraceptive


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€ million 1-year period 1-year periodMarch 31, 2019 March 31, 2018

Revenue 4.0 8.3

Operating result (15.5) (7.4)

Net result (19.7) (9.6)

Earning per share (€) (1.14) (0.66)

Cash position 21.3* 8.8**

* not including 0.7 M€ in short-term investments, 3.9 M€ in non-current financial assets and 12.5 M€ drawable under conditions from the European Investment Bank loan

** not including 0.7 M€ in short-term investments and 4.0 M€ in non-current financial assets

KEY FINANCIALS

Eemployees, Consultants and Affiliates

21%Nguyen Family*

21%

Former employees and Affiliates

25%

Other33%

P25 •

*Anh Nguyen, Chairman of MedinCell

Market Cap: c.$ 155 M

outstanding shares: 20.1 M

ISIN: FR0004065605

through long-acting injectables · mdc-irm (tv-46000) schizophrenia api: risperidone > start of...

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