medical developments international
TRANSCRIPT
DisclaimerThis presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others:
1. pricing and product initiatives of competitors;
2. legislative and regulatory developments and economic conditions;
3. delay or inability in obtaining regulatory approvals or bringing products to market;
4. fluctuations in currency exchange rates and general financial market conditions;
5. uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products;
6. increased government pricing pressures;
7. interruptions in production;
8. loss or inability to obtain adequate protection for intellectual property rights;
9. litigation;
10. loss of key executives or other employees; and
11. adverse publicity and news coverage.
There can be no assurance that any existing or future regulatory filings will satisfy any health authorities’ requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that they will reach any particular level of sales.
Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Medical Development International Limited is providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.
Any statements regarding earnings is not a profit forecast and should not be interpreted to mean that Medical Developments International’s earnings for this year or any subsequent period will necessarily match or exceed the historical published earnings of Medical Developments International. Medical Developments International Limited, its directors, officers and employees do not accept any liability whatsoever for any damage or loss caused by anything contained in this document.
For marketed products discussed in this presentation, please see full prescribing information on our website at www.medicaldev.com
All mentioned trademarks are legally protected.
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Vision
Medical Developments International (MVP) is a leading Emergency Medicine Company.
Our aim is to:
1. Provide unique and innovative products to assist our customers in the management of
acute pain, trauma and procedural pain and to be the market leader globally.
2. Provide unique and innovative products to assist our customers in the management and
delivery of respiratory medications, resuscitation and oxygen therapies and to be the
market leader in Medical Devices for Asthma and COPD markets globally.
3. Develop world leading intellectual property using continuous flow technology.
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Penthrox®
Penthrox®
• Market Leader for trauma pain
• Opiate sparing, fast-acting inhalational analgesic
• 85% of patients reach clinical analgesia within 6-10 breaths1
• Is a solution to a significant unmet clinical need
• Demonstrated safety and efficacy profile for 30+ years
• Manufactured in Australia
A world class opportunity
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1 Coffey (2014)- STOP!: A Randomised, Double-blind, Placebo-controlled Study Of The Efficacy & Safety Of Methoxyflurane For The Treatment Of Acute Pain
Global sales grew 37%
Sales in Europe and UK grew 375%
Australian ambulance sales grew 18%
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Penthrox®
In addition to the UK, Ireland, France and
Belgium, MVP has launched Penthrox in
9 of the 37 countries recently approved
(or in the process of approval)
MVP still has another 28 countries to
launch Penthrox; including Germany, Italy
and Spain.
Regulatory variations have caused the
delay in Penthrox launch in the majority of
European markets.
Significant sales growth is expected in
FY20 and beyond.
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Penthrox ®
Mar-17
Sep-17
Mar-18
Sep-18
Mar-19
Sep-19
Mar-20
Sep-20
Mar-21
Sep-21
Mar-22
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Europe launch plan
MA date In-market launch actual/estimated date
European Expansion Plans
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In addition to the 37 countries in
Europe, MVP is working towards
approval and to launch Penthrox in
another 22 countries including
China, Russia and the USA1
1: Subject to each country’s Regulatory Agencies approval
Rest of World Expansion PlansPenthrox®
Aug-16
Mar-17
Sep-17
Apr-18
Oct-18
May-19
Dec-19
Jun-20
Jan-21
Jul-21
Feb-22
Rest Of the World launch plan
MA date/esrtimated date Launch estimated date
Penthrox®
“In market” sales in the UK grew 96% in the current half
year compared to the first half of 2018.
“In market” sales in Ireland grew 30% in H2 of 2018 vs
H1 of 2018.
Focus has shifted from developing Hospital Formulary
approvals to new customers and sales.
Penthrox has been sold into 460 hospitals, clinics,
ambulance services and pharmacies in the UK and
Ireland so far.
Penthrox is currently listed in 7 Major Trauma Centres.
UK and Ireland update
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211
288
384
460
0
50
100
150
200
250
300
350
400
450
500
Total no. accounts that have ordered since launch
UK & Ireland
Jun-17 Dec-17 Jun-18 Dec-18
Penthrox ®UK and Ireland Ambulance Service Updates
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Ambulance Service Updates Status Expected Launch
National Ireland Ambulance Service Approved (using) ✓
East of England Ambulance Service Approved Q4FY19
Scottish Ambulance Service Approved (selective use) ✓
Yorkshire Ambulance Service Evaluation H1FY20
East Midlands Ambulance Services (EMAs) Evaluation (1000 patient trial) H1FY20
North West Ambulance Services Evaluation/Waiting on results of EMAs FY20
Welsh Ambulance Services Evaluation H1FY20
South East Coast Ambulance Service Evaluation H1FY20
London Ambulance Service Discussion FY20
North East Ambulance Service Discussion FY20
Dublin Fire Brigade (Ire) Approved (using) ✓
Penthrox®
Our partner is making excellent progress in Europe.
In market sales in France grew 108% H1FY19 v H1FY18.
Including UK, Ireland, France and Belgium, sales have
been made into 13 of the 41 countries in Europe.
Launch activities are planned for the remaining 28
countries including the main markets of Germany, Italy
and Spain.
Sales have been made to 422 customers.
Strong growth is expected.
Europe
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Penthrox ®
Penthrox v. Standard of Care (120 patients). The study has been completed and should be published by the end of the year.
In November 2018, an interim analysis of 35 patients was conducted. The interim analysis showed
• A reduction in total time of patient stay in the hospital of over an hour (+/-)
• A reduction of time to analgesia of approximately an hour and a half (+/-)
• A significant reduction in pain score
• A good safety profile
Note: Final publication of results may vary materially from preliminary “observed” data.
St Mary’s Major Trauma Centre, London
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Penthrox®
MVP concluded a significant transaction with Daiichi Sankyo for the China, Thailand and
Vietnamese markets.
MVP received an upfront payment of circa $21m for the commercialisation rights.
There is an additional USD $17.5m to be paid subject to performance milestone and
registrations being achieved.
The process of registration of Penthrox in China has begun.
• MVP’s Regulatory Dossier is being translated into Mandarin. This will take two more months.
• We expect to submit our IND to the Chinese Food and Drug Administration (CFDA) during
June or July of 2019.
• First sale of Penthrox in China is planned for H1FY22.
China Update
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15
2018 2019 2021
Received $22m from Daiichi Sankyo. Regulatory and Clinical experts appointed Phase I Dose ranging
Healthy Volunteer Study in China
Phase III to support existing Phase III studies and data. Can be run in parallel with Phase 1 Study
CFDA Approval
Penthrox Launch In China
Regulatory Dossier preparation, review and translation
Penthrox® clinical program for China
IND submission to Chinese FDA
File NDA with Chinese FDA
20222020
Penthrox®
Penthrox®
MVP expect to submit a Type A meeting request to the FDA during Q4FY19. MVP expect to meet with the FDA during Q4FY19.
The purpose of that meeting will be to discuss MVP’s Clinical and Non-Clinical response to the FDA “Clinical Hold” issued in August 2018.
MVP has the following additional information to discuss with the FDA:-
• MVP and its partner recently completed a Phase 1 Pharmacokinetic Study in Europe which includes 56 patients across 7 cohorts. The final reports are expected in Q4FY19.
• We are currently completing a Post Authorisation Study in Europe which includes 3200 patients and forms an important safety data base. An interim analysis has been conducted on 500 Penthrox patients (circa 1,000 patients in total). Interim report due Q4FY19.
• We have completed a Post Authorisation Survey in Europe on our “Educational Material” of 500 Healthcare Professionals and patients.
• We have years of safety data covering millions of patients.
USA Update
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Penthrox®
2017 2018 2019 2021
IND Toxicology:- 2 by 14 Day Repeat Dose
rat and dog studies- General validation and
assay studies to support existing data
IND Metabolism: - General In Vitro
studies to support existing data
Phase I Dose ranging Healthy Volunteer Study Europe
Pharmacokinetics and Toxicology Studies:- General studies to
support existing data
NDA submission to FDA
FDA Approval
Launch In USA
Safety Pharmacology:- General functional
Observational Battery studies to support existing data
USA Update
Phase I IND submission to FDA Pre NDA
meeting with FDA
FDA meeting
17
Paediatric Submission to FDA
2020
IND Amendment submission to FDA
FDA IND meeting
Phase III to support existing Phase III studies and data
2022
Penthrox®
MVP continues to invest heavily in developing the clinical profile and indications for use of Penthrox.
The purpose of our clinical program is to expand the indications for Penthrox and accelerate the adoption of Penthrox globally.
Our FY19 investment was expected to be almost $12 million. We now expect:-
The following slide is a summary of the clinical programs underway, completed or planned.
Clinical Program
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AUD $m FY19 FY20 Total
USA 1.0 7.0 8.0
China 2.6 4.0 6.6
Other 5.8 1.8 7.6
Total 9.4 12.8 22.2
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Penthrox ®Clinical Trial Pipeline
Preclinical Phase I Phase II Phase III/b Phase IV ITT
In vitros
*PK Study
PK Study
Genotoxicity
CNS study
7-day rat/dog
ED PASS Penthroxv SoC
PASS Survey & HCP
ED Paediatric
TRUS-Biopsy
*Colonoscopy
*Wound Management vs LA
*ED Penthrox v SoC
* ED Penthrox v SoC
*Mountain / harsh climate rescue
* Penthrox v SOC
*PASS * ER cost benefit
*Occupational Exposure
CompletedStart up Ongoing
14 day rat/dog
ED Pivotal study
Bone Marrow Biopsy
QT/QTc
*Concept design Panic Attacks
* Partner study
* WA ambulance retrospective linkage
Prescription takehome
Repeat use / Break Through
IUD
Pre hospital
ED Penthrox vs Tramadol retrospective
*ED Penthrox v SoC
*Real World study
Hospital Outcomes of pre-hospital
ED Penthrox vs SoC
*Bridging study
*Air Rescue
*ED Penthrox v SoC
Retrospect, ob burns & wounds
Modelling /simulation
Penthrox®
MVP’s ambition is to globalise Penthrox, and in doing so, make it the mainstream analgesic of
choice around the world. This process has begun.
Over the next 12 months+ we expect to:-
• begin selling Penthrox into another 31 countries;
• conclude additional distribution partnerships for new countries; including USA and Asia;
and
• progress work on gathering the clinical data needed to submit a “New Drug Application” to
the Food & Drug Administration in the USA and China, and extend the ‘indications for use’
for Penthrox.
Outlook
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Respiratory Division
The first half of FY19 delivered the following results:-
• Overall respiratory device sales were up 6%
• Sales into the USA grew 136%
• Sales into Asia grew 297%
• Sales of Breath-A-Tech in Australia grew 11%
• Sales into the UK fell 61%. We believe this is a timing issue and will reverse during 2019.
H1FY19
22
We have access to over 17,000 pharmacies in the USA.
There are approximately 65,000 pharmacies in the USA.
The response to our product offering in the USA has been
excellent and we are working on additional pharmacy chain
deals.
We are now adding focus to the institutional channel; IDNs and
GPOs.
We expect continued sales growth from the USA business.
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Respiratory DevicesUSA
Respiratory Devices
MVP’s ambition is to globalise the sales of its Respiratory Devices. That process has begun.
We already have partners and make sales in 26 countries.
Over the next 12 months we expect to:-
• obtain additional partnership deals in the USA and deliver sales growth;
• obtain additional partnership deals in other countries around the world;
• consolidate our position as the largest supplier of Respiratory Devices in Australia;
• introduce new products; and
• continue to drive down costs and increase the range and quality of our products.
Outlook
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Global breakthrough in API manufacturing technology
Medical Developments International (MDI) has worked with Australia’s Commonwealth
Scientific & Industrial Research Organisation “CSIRO” for almost 10 years on this project.
CSIRO is a world leading scientific academy backed by the Australian governments with
approximately 5000 scientists.
Together with MDI, CSIRO has a team of dedicated scientists working to develop global
technology to manufacture small molecule pharmaceuticals.
We intend for our Continuous Flow “CF” process API manufacturing technologies to be
covered by Patents (applications and pending) or kept as Trade Secrets depending on the
market.
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Technology
Our CF technology delivers:-
• Increased yields
• Increased purity
• Better control over process
• Increased productivity
• Lower cost of production
• Lower capex
• Less manpower
• Smaller footprint
CF has the potential to reduce the cost of API manufacturing by more than 50% compared to
batch processing. In some cases, the savings will be significantly greater.
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TechnologyOur own API - Methoxyflurane
Benefits of methoxyflurane manufacture under Continuous Flow vs Batch Process
1. Better overall process control
• 40% better reaction conversion
• 90% better overall yield conversion
• Significantly reduced impurity profile
2. Fast scale-up capability
• Increase output up x10+ on same footprint
3. Safer Environment
• Reduced manual handling
• Controlled energetic process (exotherm)
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MDI is developing its core flow technology into several generic APIs currently manufactured under standard batch processing.
Progress is being made on:-
• LIDOCAINE (USP):
We have begun the process of looking for a commercial partner for this technology. The global market for Lidocaine is estimated at USD $3.5 billion in sales
• DICHLOFENAC:
Estimated USD $6.0 billion global sales
• SALBUTAMOL:
Estimated USD $6.0 billion global sales
• CANNABIDIOL:
Early stage development in producing CBD in high purity (>98%)
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TechnologyFuture API technologies
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Penthrox® Inhaler DevelopmentsSelfie Inhaler
The Penthrox® Selfie inhaler is the next generation of inhalers
under development at MDI.
It is a fully integrated pain relief system which delivers 3ml of
Penthrox® to patients in a quick and easy manner.
The Selfie inhaler will be suitable for patients in emergency,
clinical, military and may lead to further development of home use
devices.
The Selfie system is undergoing initial trials and production is
planned for launch in 2020/early 2021.
MVP plans to invest up to $5m in plant, equipment and production
facilities to cater and promote the global expansion of Penthrox.
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Financial
$
p 24%TOTAL
Total Revenue
7,700,000
8,200,000
8,700,000
9,200,000
9,700,000
HY17 HY18 HY19
$
p 3%MEDICAL DEVICE
Total Revenue
2,920,000
2,960,000
3,000,000
3,040,000
3,080,000
HY17 HY18 HY19
$
p 21%VETERINARY
Total Revenue
290,000
310,000
330,000
350,000
370,000
HY17 HY18 HY19
$
p 37%PHARMACEUTICAL
Total Revenue
4,600,000
5,100,000
5,600,000
6,100,000
6,600,000
HY17 HY18 HY19
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Financial
INCREASE TO $32.3M
$
pCASH RESERVES
500,000
8,500,000
16,500,000
24,500,000
32,500,000
HY17 HY18 HY19
p 47%EBITDA
INCREASE TO $1.1M
$
700,000
800,000
900,000
1,000,000
1,100,000
HY17 HY18 HY19
$
OPERATING EXPENSES TO REVENUE
54.00%
56.50%
59.00%
61.50%
64.00%
HY17 HY18 HY19
$
EBITDA TO REVENUE
9.00%
10.50%
12.00%
13.50%
15.00%
HY17 HY18 HY19
Financial Summary
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Breakdown of sales revenue
UK/EU, 25%
Australia, 50%
NZ, 5%
North …
Middle East, 4%Other, 8%
Geographical Sales Revenue - FY19
UK/EU Australia NZ North America Middle East Other
UK/EU, 26%
Australia, 62%
NZ, 6%
North America,
3%
Middle East, 0% Other, 3%
Geographical Sales Revenue - FY18
UK/EU Australia NZ North America Middle East Other
MDI Investor Dashboard (ASX: MVP)
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Historical Stock Chart (3yr)
Current Stock Price
▲ 0.020 (5.051%)
27 Feb, 2:52pm
Day High 4.390Day Low 4.100
Open 4.100Prev. Close 3.960Avg. Volume 90,002
52 Wk. High 8.000 (13 Mar 2018)52 Wk. Low 3.480 (15 Feb 2019)Mkt. Cap 258.99 (Mil)
4.16
MVP Corporate Overview
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David Williams Leon Hoare Max Johnston Phillip Powell
Non-Executive Chairman
The Managing Director of Kidder Williams Ltd, with 32 years experience in investment banking.
Non-Executive Director
Recent Managing Director of Smith & Nephew in Australia and New Zealand.
Non-Executive Director
Recent MD of J&J Asia Pacific. A Non-Executive Director of Enero Group Ltd, Polynovo Limited and Chairman of Probiotec Limited.
Non-Executive Director
A Chartered Accountant and has an extensive finance background.
John Sharman Mark Edwards Thomas MateriaScott Courtney Michelle Bradney Chi Wai Ng
Head of Medical AffairsChief Executive Officer
Chief Financial Officer & Company Secretary
Business Unit Manager– Medical Devices
Director of Research & Operations
Head of Regulatory Affairs
Matthew Golden
Business Unit Manager – Penthrox
Contact Details
HEAD OFFICE
4 Caribbean Drive
Scoresby, Victoria, Australia, 3179
Tel: +61 3 9547 1888
Fax: +61 3 9547 0262
Web: www.medicaldev.com
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