39
Medical Developments International March 2019

Medical Developments International

  • Upload
    others

  • View
    3

  • Download
    0

Embed Size (px)

Citation preview

Medical Developments InternationalMarch 2019

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.

2

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.

3

4

Penthrox®

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

5

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%

6

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.

7

Penthrox ®

Mar-17

Sep-17

Mar-18

Sep-18

Mar-19

Sep-19

Mar-20

Sep-20

Mar-21

Sep-21

Mar-22

Slo

vaki

a

Au

stri

a

Po

lan

d

Slo

ven

ia

Cro

atia

No

rway

Swit

zerl

and

Po

rtu

gal

Swed

en

Spai

n

Lich

ten

ste

in

Fin

lan

d

Cze

ch R

epu

blic

Ge

rman

y

Ital

y

Icel

and

Den

mar

k

An

do

rra

Cyp

rus

Ro

man

ia

Alb

ania

San

Mar

ino

Vat

ican

cit

y

Ne

the

rlan

ds

Bo

snia

& H

erze

govi

na

Mal

ta

Gre

ece

Hu

nga

ry

Serb

ia

Bu

lgar

ia

Esto

nia

Latv

ia

Lith

uan

ia

Luxe

mb

ou

rg

Mac

edo

nia

Mo

nte

neg

ro

Ko

sovo

Europe launch plan

MA date In-market launch actual/estimated date

European Expansion Plans

8

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®Penthrox global expansion plans

9

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

10

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

11

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

12

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

13

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

14

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

16

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

18

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

19

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

20

21

Respiratory and Medical Devices

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.

23

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

24

Continuous Flow

A new way to manufacture API

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.

26

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.

27

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)

28

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%)

29

TechnologyFuture API technologies

Product Development Update

31

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.

32

MVP Corporate

33

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

34

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

35

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)

36

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

37

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

38

0817