impact with long-acting injectables … · • phase 2 completed for mdc-cwm (pain &...
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BUILDING A GLOBAL PHARMA LEADER Impact with Long-Acting InjectablesCorporate Presentation - June 2020
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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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• Most advanced product in clinical phase 3 (mdc-IRM, schizophrenia) > Interim results in H2 2020
• Phase 2 completed for mdc-CWM (Pain & inflammation - opioid free) > Start of phase 3 in Q4 2020
• Tier 1 partnerships > Teva Pharmaceuticals and the Bill & Melinda Gates Foundation
• Solid and reinforced financial visibility (more than 12 months)
• Products based on approved APIs and 505(b)2 regulatory pathway
• Polymer joint-venture with Corbion (Amsterdam: CRBN) > GMP polymers available at commercial scale
INVESTMENT HIGHLIGHTS
P3 •
mdc-IRMSchizophreniaSubcutaneous injection
Partner: Teva pharmaceuticals
mdc-CWMPain & inflammation (opioid free)Intraarticular injection
Partner: Arthritis Innovation Corporation
mdc-TJKAntipsychoticSubcutaneous injection
Partner: Teva pharmaceuticals
Preclinical Clinical phase 1 Clinical phase 2 Clinical phase 3 NDA / MarketFormulation
Next potential candidates for preclinical & IND/IMPD > 9 products in formulation and preclinical
IND / IMPDApproval for Human Clinical Trials
PORTFOLIO(as of May 1st, 2020)
StudyCompleted
Recruitmentcompleted
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• 12.4 M€ in cash and cash equivalents• 3.6 M€ of risk-free financial assets (0.4 M€ current + 3.3 M€ non-current)• 5.0 M€ drawable from the EIB loan
Consolidated financial position as of March 31, 2020
• 10.9 M€ non-dilutive financing (PGE ) - May 2020• 3.1 M€ received as CIR in - May 2020• 15.6 M€ of capital increase (offering to qualified investors) - June 2020
Post closing
LAST 12-MONTH NEWSFLOW & CASH POSITIONPress releases are available on invest.medincell.com
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2020
Initiative to address untapped financial potential in Animal Health
Announcement ofCovid-19 research project
mdc-CWM clinical phase 2 completed
FDA IND clearance to initiate clinical activities of mdc-TJK
New grant from the Gates Foundation for feasibility study for HIV PrEP
Start of first in human for mdc-TJK
Additional $19 M grant from the Bill & Melinda Gates Foundation for mdc-WWM
US Pharma Development Veteran Dr. Richard Malamutjoins the Medical Advisory Board
$6.4 million grant from Unitaid to fight Malaria
MayJune August September October November December January February March
2019
April
mdc-ANG enters preclinical development
7,5 M€ from the European Investment Bank
July
11.9 M€ non-dilutive financing secured (PGE)
mdc-IRM clinical phase 3 recruitment completed
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CLINICAL UPCOMING DEVELOPMENT NEWSFLOWAs programs based on MedinCell’s technology move into more advanced phases, data, analysis and conclusions may only be communicated on an ad hoc basis to preserve clinical study integrity and competitive positioning
mdc-TJKPartner: Teva pharmaceuticals
Start date: Q4 2019Primary endpoints : Safety
Phase 1Safety study
Current status
> US Phase 1 results > 2021
Next potential milestoneProgram
mdc-CWMPartner: Arthritis Innovation Corporation
Start date: May 2018
Enrollment: 20 participantsPrimary endpoints : pain measures and post-surgical opioid consumption
Phase 2 completedA Phase 2, randomized, single-blind, active-control, parallel groupstudy to evaluate safety and activity of a single administrationof celecoxib for management of postoperative pain in participantsundergoing unilateral total knee replacement (TKR)
Current status
> Start of US Phase 3 > Q4 2020
Next potential milestoneProgram
mdc-IRMPartner: Teva pharmaceuticals
Start date: April 2018
Enrollment: 863 participants (completed)Primary endpoint : Time to impending relapse
Estimated completion date: H2 2020
Phase 3A multicenter, randomized, double-blind, placebo-controlled studyto evaluate the efficacy, safety, and tolerability of risperidoneextended-release injectable suspension for subcutaneous use asmaintenance treatment in adult and adolescent patients withschizophrenia
Current status
> US Phase 3 interim analysis > H2 2020
Next potential milestoneProgram
US Phase 3 interim analysis
> H2 2020
Start of US Phase 3> Q4 2020
US Phase 1 results
> Q1 2021
Covid-19 crisis > Teva Pharmaceuticals has not communicated changes in ongoing clinical trials (antipsychotics)
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COVID-19> THE THIRD PATH: PREVENTION
• Covid-19 project launched in March 2020 (mdc-TTG)
• A third way between a treatment and a vaccine
• Long-acting injectable Ivermectin formulation for several months for prophylactic (preventive) action in people who are not infected
• Ivermectin has long been considered a safe and effective drug to treat some parasitic diseases and its action on viruses has been proven in vivo or in vitro in the past
• MedinCell already published data showing that Ivermectin can be formulated with its BEPO®
technology
• Studies have shown potential effectiveness of Ivermectin against Covid-19
A design-to-time development strategy
Press release - 2020, June 4
The program is advancing on three fronts in parallel to optimize deadlines, in collaboration with renowned scientists and institutes:
• In vitro validation of the protective effect of Ivermectin on Covid-19 cell strains. Results expected for 2020
• Phase 1/2 clinical studies in preparation with oral Ivermectin for potential initiation in the coming weeks with objectives to validate safety and activity in regular dosage for prophylaxis. These studies could be carried out on different populations, especially those most at risk, in areas where the outbreak is active. Results expected by the end of 2020 depending on the evolution of the pandemic.
• In vitro and in vivo development and validation of 1-month and 3-month formulations of Ivermectin. The first candidate formulations could be ready in early 2021 for regulatory development.
The objective is to be able to carry out a phase 3 in 2021 in the event of a rebound of the epidemic.
MedinCell is working on the different funding tools that have been created to support research programs related to Covid-19.
P6 •
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BEPO®Long-acting injectable cutting edge technology
P7 •
Formulation
Polymers customized formulation for each indication
• PEG/PLA
• Hydrophilic solvent
• Active pharmaceuticals Ingredient
Subcutaneous or local injectionIn situ depot precipitates immediately after subcutaneous or local injection
Controlled release
API is released as depot fully degrades
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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 approved API > same indication
Space impact > known approved API> new indication
WE APPLY OUR LAI TECHNOLOGY BEPO®
TO MAKE DRUGS EFFICIENT
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WE APPLY OUR LAI TECHNOLOGY BEPO®
TO ALREADY KNOWN APPROVED APIs
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 original indication
HIGH
LOWLOW
HIGH
RET
UR
N
SUCCESS RATE
GENERIC
NCE(New Chemical Entity)
LAIs with approved APIs
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Portfolio3 products in clinical trials
P10 •
mdc-IRMSchizophreniaSubcutaneous injection
Partner: Teva pharmaceuticals
mdc-CWMPain & inflammation (opioid free)Intraarticular injection
Partner: Arthritis Innovation Corporation
mdc-TJKAntipsychoticSubcutaneous injection
Partner: Teva pharmaceuticals
Preclinical Clinical phase 1 Clinical phase 2 Clinical phase 3 NDA / MarketFormulation
IND / IMPDApproval for Human Clinical Trials
StudyCompleted
Recruitmentcompleted
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Portfolio3 products in clinical development
mdc-IRMSUBCUTANEOUS RISPERIDONE First long-acting injectable antipsychotic with Teva Pharmaceuticals
Maintenance treatment of schizophrenia
Current status: US Phase 3 (efficacy, safety and tolerability) - Initiated Q2 2018 - 863 patients
All development costs covered by Teva Pharmaceutical
mdc-IRMSchizophreniaSubcutaneous injection
Partner: Teva pharmaceuticals
Preclinical Clinical phase 1 Clinical phase 2 Clinical phase 3 NDA / MarketFormulation
IND / IMPDApproval for Human Clinical Trials
Exempted 5O5(b)2Completed
Next potential milestone
US Phase 3 interim analysis
> H2 2020
Recruitmentcompleted
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Portfolio3 products in clinical development
mdc-IRMSUBCUTANEOUS RISPERIDONE
> SCHIZOPHRENIA: A CHRONIC PSYCHOSIS AFFECTING 1% OF POPULATION WW
An extremely debilitating disease
Positive symptoms: hallucinations, disorganized speech, delusions
Negative symptoms: flat affect, poverty of speech
Cognitive symptoms: attention, memory, executive functions
Nonadherence to prescribed treatments
74% of patients had discontinued medication within 18 months due to insufficient efficacy, intolerable side effects or for other reasons (Lieberman J. (2005) Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 353: 1209–1223)
Schizophrenia in the US Schizophrenia accounts for 20% of all hospital bed-days and over 50% of all psychiatric beds1
Annual cost: Between $134 and $174 billion per year2
$38 billion for excess direct health care costsHospital inpatient treatment, outpatient and emergency department visits, medications
$9 billion for direct non–health care costsLaw enforcement, incarceration, homeless shelters
$117 billion for indirect costsUnemployment, lost productivity, premature mortality Sources: 1 Comprehensive understanding of schizophrenia and its treatment, Maguire GA. Am J Health Syst Pharm. 2002 ; 2 Analysis Group, Otsuka, Lundbeck LLC - 2016
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Portfolio3 products in clinical development
mdc-IRMSUBCUTANEOUS RISPERIDONE
> ATYPICAL ANTIPSYCHOTICS LAIs: A $5.2 BILLION MARKET GROWING +20% CAGR (7 Major Markets)
Global atypical antipsychotics sales $ billion - 7 MM - 2018
1,7 2,2 2,6 2,9 3,6 4,3 5,2
15,9 15,417,4
16,2
13,3 12,6 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
1.72.2
2.93.6
2.6
4.3
USA is largest market: 77% of sales
Fastest Growth (+25% CAGR)
89%
11%
Oral LAI
LAIs account for only
11% of patients
LAI atypical antipsychotics sales $ billion - 7MM - 2018
Global atypical antipsychotics patients
7MM - 2016
Source: IMS Sales date, Midas & Globaldata
5.2Japan
EU
US
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mdc-TJKAntipsychoticSubcutaneous injection
Partner: Teva pharmaceuticals
Preclinical Clinical phase 1 Clinical phase 2 Clinical phase 3 NDA / MarketFormulation
IND / IMPDApproval for Human Clinical Trials
mdc-TJKSUBCUTANEOUS ANTIPSYCHOTIC Second long-acting injectable antipsychotic with Teva Pharmaceuticals
API: confidential
Current status: US Phase 1 (safety) - Initiated Q4 2019
All development costs covered by Teva Pharmaceuticals
Portfolio3 products in clinical development
P14 •
Next potential milestone
US Phase 1 results
> Q1 2021
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All development costs covered by TEVA
MedinCell receives
• FTE remuneration in formulation
• Development and commercial milestones of up to $122m for each product ($366m total)
• Royalties on sales
TEVA COLLABORATION> 3 ANTIPSYCHOTICS
P15 •
mdc-IRMSchizophreniaSubcutaneous injection
Partner: Teva pharmaceuticals
mdc-TJKAntipsychoticSubcutaneous injection
Partner: Teva pharmaceuticals
Preclinical Clinical phase 1 Clinical phase 2 Clinical phase 3 NDA / MarketFormulation
IND / IMPDApproval for Human Clinical Trials
Subcutaneous injection• mdc-ANG
(Partner: Teva pharmaceuticals)
Development milestones Commercial milestones & royaltiesFTE remuneration
Press release – Dec. 3, 2019
Clinical activities begin for Second Long-acting Injectable Antipsychotic mdc-TJK. The first-in-human study for the investigational long-acting injectable antipsychotic mdc-TJK has now commenced. The results of this study, expected during 2021, will inform future development. mdc-TJK is one of three antipsychotic products in development by the partner Teva Pharmaceuticals based on MedinCell’s technology.
The phase 3 clinical trials for the lead asset, mdc-IRM, are ongoing with an interim analysis in the second half of 2020 contingent upon the projected recruitment rate and patient relapse events.
Preclinical work on the third investigational product, mdc-ANG, continues to progress and will inform a decision on further development expected in the second half of 2020.
Press release – Apr 23, 2020
Our partner Teva Pharmaceuticals has not communicated changes in clinical trials
Recruitmentcompleted
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Preclinical Clinical phase 1 Clinical phase 2 Clinical phase 3 NDA / MarketFormulation
mdc-CWMAntipsychoticSubcutaneous injection
Partner: Teva pharmaceuticals
IND / IMPDApproval for Human Clinical Trials
mdc-CWMINTRA-ARTICULAR CELECOXIB INJECTIONCollaboration with AIC
Total Knee Replacement (TKR) post-operative pain and inflammation treatment
Current status: US Phase 2 (safety and activity) completedClinical development cost borne by AIC
Portfolio3 products in clinical development
P16 •
Exempted 5O5(b)2
Press release – April 23, 2020
Our partner plans to go directly into Phase 3 before year end for mdc-CWM (post-operative pain and inflammation)
• Phase 2 for mdc-CWM is now completed. Our partner expects favorable results. For strategic and competitive reasons these results will not be communicated for the time being.
• Our partner expects to meet with FDA this summer to confirm the clinical strategy.
The product is for management of postoperative pain in participants undergoing unilateral total knee replacement. The study’s primary endpoints include pain measures and post-surgical opioid consumption. MedinCell’s CEO Christophe Douat adds: “While total knee replacement surgery leads to decreased pain in most patients, a sizable minority continue to experience severe pain and consume opioids chronically after it. It is one of the surgeries were patients use the most opioids and an estimated 15 % of these, or 150 000 patients per year, become new persistent opioid users for many months after surgery. A decrease in pain and opioid consumption should be viewed as a very positive factor in the current opioid crisis, which is one of the highest priorities of the FDA.”
Next potential milestone
Start of US Phase 3
> Q4 2020
StudyCompleted
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mdc-CWMINTRA-ARTICULAR CELECOXIB INJECTION
Portfolio3 products in clinical development
> A STRONG MARKET OPPORTUNITY
Unsatisfying post-surgery pain treatment
Significant pain for two weeks and reduced but continued pain for 6-12 weeks post surgery
Contraindication of traditional oral anti-inflammatory products post surgery
Effectiveness of current practices for postoperative pain management remains limited: 57% to 73% of operated patients report moderate to extreme postoperative pain, leading to longer hospitalization stay, revision surgery, disability leave, etc.Source: 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
Opioids epidemic issue 15.2% of TKR patients become long-term opioid usersSource: 2018 Choices Matter Survey - Exposing a silent gateway to persistent opioid use
The use of opioids in the treatment of postoperative pain is globally widespread and particularly in the US: c. 90% of operated patients
Negative side effects observed in 96% of operated patients, increasing the duration of hospitalization in 55% of cases
130 people die every day in the US because of opioids overdose according to the CDCSources: 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 ; sler 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
0.7M
2010
1.5M
2030 forecast
NUMBER OF TKR PROCEDURES IN THE USSource: GlobalData, Orthopedic Devices [Knee Reconstruction] Market, United States, 2009-2023, Absolute Units, 2017
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mdc-CWMINTRA-ARTICULAR CELECOXIB INJECTION
Portfolio3 products in clinical development
> PRODUCT DETAILS
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 three 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
Partner& deal metrics
AIC (Arthritis Innovation Corporation): Company founded by North American physicians & entrepreneurs
All development costs borne by AIC
50-50 profit sharing
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
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Next potential candidates for Preclinical & IND
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PROGRAM PARTNER / INTERNAL CURRENT STATUS INDICATION MOLECULE MAIN TARGETED IMPACT
mdc-ANG Partner: Teva Pharmaceuticals
Preclinical Antipsychotic confidential Adherence
mdc-GRT MedinCell program Formulation Organ transplant Tacrolimus Adherence
mdc-WWM Partner: the Bill & Melinda Gates Foundation
Preclinical Women’s contraception Progestin molecule (non-MPA)
Large access to best-in-class women’s contraceptive
mdc-STM Partner: Unitaid Formulation Malaria Ivermectin Large access and adherence
mdc-TTG MedinCell program Formulation Covid-19 Ivermectin Adherence and Access
mdc-STG MedinCell program Formulation Confidential Confidential Confidential
mdc-KPT (Animal Health) Formulation Pain Confidential Duration
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.
NEXT POTENTIAL CANDIDATES FOR PRECLINICAL & IND > 9 PRODUCTS IN FORMULATION AND PRECLINICAL
> SUBCUTANEOUS INJECTION
PROGRAM PARTNER / INTERNAL CURRENT STATUS INDICATION MOLECULE MAIN TARGETED IMPACT
mdc-CMV MedinCell program Preclinical Anesthesia & pain (opioid free)
Ropivacain Opioid free
mdc-NVA MedinCell program Formulation Chronic pain (opioid free)
Ropivacain Opioid free
> PERINEURAL INJECTION
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Collaboration with theBill & Melinda Gates Foundation
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Press release – November 28, 2019
MedinCell receives $19 million grant for its mdc-WWM program
French company MedinCell and the Bill & Melinda Gates Foundation have signed an agreement for up to an additional $19 million to be granted over four years. It aims to fund preclinical activities and a phase 1 clinical trial for the injectable six-month bioresorbable contraceptive (mdc-WWM). The grant is structured in advanced installments to cover the costs that will be incurred by the project. Depending on the options chosen and on the advancement of the program, up to $11.75 million could be raised over the next 12 months including a first tranche of $4.75 million to be paid immediately. The additional $7.25 million may be collected later.
As a reminder, a previous grant of $3.5 million was awarded in November 2017 by the Gates Foundation to fund the formulation research phase. Full results should make it possible to select the candidate formulation.
MedinCell owns all marketing rights of the product worldwide, including the United States where the contraceptive market totaled more than $5 billion in 2018. Long-acting reversible contraceptives (LARC) alone (primarily solid implants and intrauterine devices) represented 28% of this market - more than $1.4 billion – with a 5-year CAGR at 7.8%. The mdc-WWM product could capture a significant share of this LARC market and even expand it easing the adoption of this type of contraception1.
In accordance with the Global Access strategy of both partners and to ensure a significant impact on women’s lives, the objective is to make the product widely available. Affordable pricing in emerging economies will help eliminate cost as a barrier to increased availability and voluntary access to the product. High demand among women and girls for long-acting contraceptive options illustrate the potential for market growth and measurably improving maternal, newborn and child health. The Gates Foundation also has a non-exclusive license for non-commercial market in low- and middle-income countries.
Collaboration with the Bill & Melinda Gates Foundation
> ADDRESSING MAJOR CHALLENGES OF FAMILY PLANNING WORLDWIDE
> EXPLORATORY WORK IN HIV PrEP
Press release – September 5, 2019
MedinCell receives a new grant to develop a best-in-class longacting injectable product for HIV PrEP
Pre-exposure prophylaxis (PrEP) strategy has proven efficacy in preventing HIV infection via daily oral administration of antiretroviral drugs. However, lack of adherence to an oral PrEPregime undermines its effectiveness. A combination of an investigational PrEP single-agent with MedinCell's long-acting injectable technology could guarantee several months of prevention after a single subcutaneous injection. The support of the Bill & Melinda Gates Foundation aims to confirm the feasibility of the product and to initiate the design of a lead formulation that could rapidly enter investigational development.
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Collaboration with the Bill & Melinda Gates Foundation
> mdc-WWM: 6-MONTH SUBCUTANEOUS CONTRACEPTIVE
The challenge of family planning worldwide
An estimated 74 million women fall pregnant unintentionally every year leading to 25 million unsafe abortions and 47,000 maternal deaths (WHO - Oct. 2019)
Best-in-class product mdc-WWM could be the first contraceptive to combine the following essential features to make it a best-in-class product worldwide: progestin molecule (non-MPA), 6-month duration, subcutaneous injection, full bio resorption, affordability
November 2019Up to $19 million additional grant over four years to fund preclinical activities and phase 1 clinical trial. The grant is structured in advanced installments to cover the costs that will be incurred by the project
December 2017$3.5 million grant to fund the formulation of the product
> MEDINCELL OWNS THE COMMERCIAL RIGHTS WORLDWIDE, ESP. IN THE US
US contraceptive market in 2018 > $5 billion
Long-acting reversible contraceptives - LARC (primarily solid implants and intrauterine devices)
> 28% of the US market> $1.4 billion> 5-year CAGR at 7.8%
mdc-WWM product could capture a significant share of this LARC market and expand it by easing the adoption of this type of contraceptionSource: IQVIA
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Impact company
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> 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 treatments (World Health Organization: Adherence to Long-Term Therapies, Evidence for Actions - 2003)
• LAI can impact both compliance and access issues
> Affordability should allow to tap profitability reservoir on developing countries• Much higher volumes will counter balance pricing
• Low COGS technology
> Pharmaceutical residues becoming a major environmental challenge• Up to 95% less APIs required for a same treatment
• 1/3 of US presription become waste(MedinCell estimates on potential positive impact of BEPO)
WE CONTRIBUTE TO SOLVING GLOBAL HEALTH CHALLENGES
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> 25 nationalities out of 140 employees
> 100% of MedinCell employees are shareholders or soon to beEmployee share ownership is promoted through adapted tools that guarantee alignment of the interests of employees and other shareholders. It enables a fair sharing of the value created and a balanced relationship between management and all employees
> Reduced salary gaps
> Collective bonus linked to product progress
A XXIst CENTURY PHARMA COMPANY MODEL
“Our mission is to contribute to the improvement and protection of the health of populations across the world. The fair sharing of the value created with all our employees is the foundation of our business model. The sustainability of MedinCell is an essential condition for achieving our objectives.” “Raison d’e ̂tre” of MedinCell voted by the General Assembly in September 2019
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€ million 12-Month period 12-Month periodMarch 31, 2020 March 31, 2019
Revenue 6.0 4.0
Operating result (19.3) (15.5)
Net result (23.9) (19.7)
Earning per share (€) (1.19) (1.14)
Cash position 12.4* 21.3**
* not including 0.4 M€ in short-term investments, 3.3 M€ investments in non-current financial assets, 3,1 M€ of CIR (Crédit Impôt Recherche) cashed in May, 10.9 M€ loan obtained in May 2020, 5 M€ drawable from the European Investment Bank loan, 15.6 M€ capital increase in June 2020
** not including 0.7 M€ in short-term & 3.9 M€ investments in non-current financial assets
KEY FINANCIALS
Employees, Consultants and Affiliates
14%
Nguyen Family*19%
Other41%
Former employees and Affiliates
26%
P28 •
*Anh Nguyen, Chairman of MedinCell
Market Cap: c. 185 M€
outstanding shares: 22.2 M
ISIN: FR0004065605
Covid-19 crisis > MedinCell strengthened its financial visibility during this period• Budgetary savings measures (operations linked to strategic research and
development programs maintained)• Ongoing activities to secure cash: State Guaranteed Loan (PGE), remaining line
of credit of 5 million euros with the European Investment Bank, capital increase
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