JEFFERIES 2019 Cosmo Pharmaceuticals
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JEFFERIES
2019
Cosmo Pharmaceuticals
C O S M O : L AT E S T N E W S S I N C E R E L E A S E O F F U L L Y 2 0 1 8 F I N A N C I A L S
Unveiling of the artificial intelligence product
01 and subsequent worldwide validation deal with Medtronic
Distribution deal of Eleview with Medtronic for US, China and South America
02
Collaboration agreement with Medtronic in AI
03
04 Submission of ByFavo TM (Remimazolam) NDA
05 Acceptance of IND for new oncologic product
Completion of Aries restructuring, savings of approx. € 20m in 2019
06
07 Very positive results of Breezula full phase II clinical trial
Cosmo Pharmaceuticals 2 Jefferies 2019
C O S M O : A H I G H LY D I V E R S I F I E D O R G A N I Z AT I O N
Cosmo is a sum of different business and assets, a complex organization whose
aim is to efficiently develop and manage assets while reducing overall risks
Contract AI
manufacturing (APPROVED IN EU, US
REGULATORY PATHWAY
UNDERGOING)
CB-03-10
(APPROVED FOR TD, PHASE II (SECOND PHASE III TRIAL
IBS-D ONGOING) (NDA SUBMITTED) (IND ACCEPTED) UNDER DESIGN) 45% STAKE
Cosmo Pharmaceuticals 3 Jefferies 2019
OUTLOOK A consistent diversified pipeline in different stages of development Four products already in the market One new product ready to enter the market Net cash of € 337m at May 30, 2019 Convertible financing raised to build up commercial infrastructure and scale up of AI business: now not necessary after deal with Medtronic, increases firepower Ready to capture additional opportunities Cosmo Pharmaceuticals 4 Jefferies 2019
AI Cosmo Pharmaceuticals 5 Jefferies 2019
AI OPPORTUNITY THE AI PARTNERSHIP WITH MEDTRONIC – OUR REVENUES ARE PROFITS • Territory: worldwide • Distribution agreement including supply • Estimated Net Margin for Cosmo expected above 20% • Devices currently being deployed with EU KOLs to prepare commercial launch • EU Sales expected to start 2H 2019 • US sales expected to begin 2020, upon FDA approval • Medtronic established business model: user fees • Estimated yearly fee per device in US/EU: USD/€ 36.000 • Estimated number of endoscopy towers in the US: 20.000 Cosmo Pharmaceuticals 6 Jefferies 2019
A I O P P O R T U N I T Y: N E X T S T E P S
Distribution to
Device is already
European KOLs is
approved in EU
ongoing
Device presented at FDA regulatory path
DDW underway
Expected US market
entry Q1 2020
Cosmo Pharmaceuticals 7 Jefferies 2019
Cosmo Pharmaceuticals 8 Jefferies 2019
ELEVIEW – US MARKET OPPORTUNITY
• 16m US colonoscopies annually
• 2.4 average polyp/patient as found in MB MMX trial: total
38.4 million lesions
• 8% of polyps required injection: total injection approx. 3m
• Average 1.5 vial per removal: total 4.5 million vials
• Current price: $ 81 per vial
• Market Opportunity approx. $350m
• Estimated peak sales $65 - 75m (20% of the market)
• 2018 sales $ 11m
• Time line to peak sales 7 - 8 years
Cosmo Pharmaceuticals 9 Jefferies 2019
ELEVIEW OPPORTUNITY
OUR REVENUES ARE PROFITS
• Stop direct distribution of medical devices in the US,
with Medtronic as partner of choice
• New US distribution agreement (including supply) with
Medtronic for Eleview extended to
China and South America
• Estimated Net Margin for Cosmo expected above
20%
Cosmo Pharmaceuticals 10 Jefferies 2019Cosmo Pharmaceuticals 11 Jefferies 2019
AEMCOLO – US MARKET OPPORTUNITY • Sales of Xifaxan $ 1.3 billion • Estimated Market Opportunity at least $1 billion • 20-25% market share • Estimated peak sales $ 200 - 250m • Estimated time line to peak sales 7 - 8 years • Physicians perceive advantages vs Xifaxan Cosmo Pharmaceuticals 12 Jefferies 2019
A E M C O L O : N O W A P P R O V E D F O R T R AV E L E R S ’ D I A R R H E A
Approved in US for
Travelers’ Diarrhea
Nov. 2018
Cosmo Pharmaceuticals 13 Jefferies 2019A E M C O L O – S T R O N G F U T U R E T H R O U G H A D D I T I O N A L I N D I C AT I O N S
• New formulation in multicenter phase II clinical trial in
Europe for IBS-D
• Phase II IBS-D trial expected to end of 2019
• Further development ongoing/being initiated in:
• Minimal Hepatic Encephalopathy
• IND and study protocol accepted by FDA
• Study close to initiation
• Acute Uncomplicated Diverticulitis
• Protocol under development
• Small Intestine Bacterial Overgrowth (SIBO)
• Protocol under development
Cosmo Pharmaceuticals 14 Jefferies 2019A E M C O L O : P E R F E C T LY TA I L O R E D F O R T R AV E L E R S ’ D I A R R H E A 1 , 2
• Non-systemic, minimally absorbed
• MMX® delivery to the colon AEMCOLO OFFERS A CURE TO
TRAVELERS’ DIARRHEA
• Proven efficacy against E. coli
ELIMINATING THE
• Reliable safety and tolerability SHORTCOMINGS OF OTHER
TREATMENTS
• Simple BID dosing
• No increase in ESBL-E colonization
rates/lower risk of acquisition
1. DuPont, HL, et al. Targeting of Rifamycin SV to the Colon for Treatment of Travelers’ Diarrhea: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study,
Journal of Travel Medicine, Vol. 21:369–376, 2014. 2. Steffen, R, et al, Rifamycin SV-MMX® for treatment of Travelers’ diarrhea: equally effective as ciprofloxacin and
not associated with the acquisition of multi-drug resistant bacteria, Journal of Travel Medicine, 2018, published online ahead of print, Accessed Dec 9, 2018
Cosmo Pharmaceuticals 15 Jefferies 2019A E M C O L O F O R T R AV E L E R S ’ D I A R R H E A : N O W R E C O M M E N D E D B Y T H E I N T E R N AT I O N A L S O C I E T Y O F T R AV E L M E D I C I N E ( I S T M ) “In conclusion, no single drug is perfect against Traveler's diarrhea. We rate the advantages of non-absorbed antibiotics — reduced risk of adverse events, improvement in disease in most patients with illness, reduced risk of acquisition of multiple drug resistant organisms (so far demonstrated only for Rifamycin SV- MMX®) and lastly protection of systemic antibiotics against resistance — greater as compared to the disadvantages such as personal harm and public health impact that a small minority of Traveler's diarrhea patients with invasive illness would not be initially treated by a systemic antibiotic as first line drug from a travel kit for self-treatment.” Cosmo Pharmaceuticals 16 Jefferies 2019
A E M C O L O F O R T R AV E L E R S ’ D I A R R H E A : S U P P O R T E D B Y T H E F D A Cosmo Pharmaceuticals 17 Jefferies 2019
T R AV E L E R S ’ D I A R R H E A : H O W T O C A P T U R E T H E O P P O R T U N I T Y
• Targeting Travelers rather than patients
requires a different approach
Need to target the Travelers while
• The Travelers’ Diarrhea market cannot be they’re making plans, and make it
approached with the traditional means easy to get the product
because most Travelers do not typically
visit their doctor prior to departure
Cosmo Pharmaceuticals 18 Jefferies 2019T R AV E L E R S ’ D I A R R H E A I S A H U G E M A R K E T
Population of Canada
37M
Population of Benelux Number of Americans
28M traveling EVERY YEAR to at risk
countries where the ISTM recommends
bringing an antibiotic with them
Population of Switzerland
8.4M 46 Million
Entire US population with IBD
3M
Cosmo Pharmaceuticals 19 Jefferies 2019T R AV E L E R S ’ D I A R R H E A I S A H U G E M A R K E T
70M
Americans Travelling Abroad 8.7 billion minutes (+41% Y/Y)
46M spent on digital travel content in the US
TOTAL US INTERNET MINUTES GREW BY 7%
Visit Developing
Countries
Priority
targets
>36% are seeking health advice before
they leave1
1 – “Travel Health, Knowledge, Attitudes and Practices among United States Travelers.” J Travel Med 2004; 11:23–26.
Cosmo Pharmaceuticals 20 Jefferies 2019T R AV E L E R S ’ D I A R R H E A I S A H U G E M A R K E T High travel spending per person in the US facilitates big commercial opportunity https://www.aarp.org/content/dam/aarp/research/surveys_statistics/life-leisure/2017/2018-travel-trends.doi.10.26419-2Fres.00179.001.pdf Cosmo Pharmaceuticals 21 Jefferies 2019
A E M C O L O B U S I N E S S M O D E L W I T H U S T R AV E L E R S
Increase Traveler awareness and perception of risk to drive traffic to the website
Online DTC MARKETING Limited HCP
AEMCOLO WEBSITE
CONDITION, PRODUCT AND Telemedicine
PRESCRIBING INFORMATION
Provider Online
e-Rx HOME DELIVERY
consultation
OF AEMCOLO
Link to telemedicine provider with HCP
THE BUSINESS MODEL TAPS INTO KEY POINTS OF INFLUENCE, AND LEVERAGES NEW TECHNOLOGIES/BUSINESS MODELS TO PROVIDE EASIER ACCESS TO TRAVELERS
Cosmo Pharmaceuticals 22 Jefferies 2019T R E N D S I N H E A LT H C A R E >95% of community pharmacies do e-prescribing Cosmo Pharmaceuticals 23 Jefferies 2019
T R AV E L E R S ’ D I A R R H E A : H O W T O C A P T U R E T H E O P P O R T U N I T Y
LEVERAGE EXPERIENCE & BRING ON BOARD
The well known players in the field
Strong marketing partner
• Experienced marketing partner
Cosmo US commercial organization
• Direct experience in Travelers’ health
has direct experience in GI, consumer
• Strong international team
health/ marketing, digital marketing
Strong execution partner
• End to end provider – telemedicine through to
warehousing, pharmacy dispensing, and home
delivery
Cosmo Pharmaceuticals 24 Jefferies 2019A E M C O L O B U S I N E S S M O D E L W I T H T R AV E L E R S : B E N E F I T S MORE STRAIGHTFORWARD SALES AND DISTRIBUTION • Remove need for large sales infrastructure • Reduce complexity for the wholesalers and distribution chain in Travelers’ diarrhea MARKETING DIRECTLY TO THE TRAVELER • KOLs are important stakeholders but limited direct detailing to broad HCP population required WILL BE ABLE TO USE REAL TIME FEEDBACK FROM THE VALUE CHAIN TO HELP REFINE MARKETING CAMPAIGNS, REBATE PROGRAMS, MESSAGING ETC. • Expand promotion and messaging to physicians Cosmo Pharmaceuticals 25 Jefferies 2019
Cosmo Pharmaceuticals 26 Jefferies 2019
B Y FAV O ( R e m i m a z o l a m )
U S P R O C E D U R A L S E D AT I O N M A R K E T O P P O R T U N I T Y
• 24.5m Annual U.S. Colonoscopies, Upper GI
Endoscopies and Bronchoscopies
• 90% of U.S. Colonoscopies, Upper GI
NDA FILED APRIL 2019,
Endoscopies and Bronchoscopies used Moderate
APPROVAL EXPECTED
Sedation
APRIL 2020
• Estimated Market Opportunity in procedural
sedation $ 600m
• Estimated peak sales $150m – $200m
• Estimated timeline to peak sales: 5 - 7 years
Cosmo Pharmaceuticals 27 Jefferies 2019CB-03-10 Cosmo Pharmaceuticals 28 Jefferies 2019
CB-03-10:
P H A S E 1 R E A D Y A N D R O G E N R E C E P T O R A N TA G O N I S T F O R S O L I D T U M O R S
CB-03-10 was selected from a Compound Library owned by Cosmo Pharmaceuticals
CB-03-01/Clascoterone
Several Cosmo Pharmaceuticals For Acne Treatment (Winlevi)
Compounds, derived from For Alopecia Treatment (Breezula)
Cortexolone were screened as
potential treatment for Diseases
dependent on the Androgen
receptor
CB-03-10
For Treatment of Solid tumors
Cosmo Pharmaceuticals 29 Jefferies 2019C B - 0 3 - 1 0 P H A S E 1 M U LT I C E N T E R T R I A L Part 1 Dose escalation: Up to 27 patients Subjects with advanced refractory tumors Part 2 Dose expansion: Up to 63 patients Defined subject sub-groups showing meaningful clinical activity in Part 1 Cosmo Pharmaceuticals 30 Jefferies 2019
S U M M A RY
CB-03-10 is a highly potent AR and GR antagonist with impressive anti-tumor activity
Potential for first and second line therapy in Pancreatic, Colon and other cancers
Regulatory Toxicology shows oral dosing is Safe and Well-Tolerated
IND approved without revision by the FDA
Phase 1 Clinical trial scheduled to begin 4Q 2019
Potential licensing partners looking to execute a deal
Cosmo Pharmaceuticals 31 Jefferies 2019Cosmo Pharmaceuticals 32 Jefferies 2019
MB MMX – US MARKET OPPORTUNITY • 16m U.S. colonoscopies annually, 74% colorectal cancer related • 12m U.S. colorectal cancer related colonoscopies • 31% colonoscopies in IBD patients/high risk patients • Estimated Market Opportunity $3 billion • Estimated peak sales $600m - $700m • Estimated time line to peak sales 7 - 8 years • Next steps: reach agreement with FDA re additional phase III trial and start such trial • New phase III trial expected to begin 1Q 2020 Cosmo Pharmaceuticals 33 Jefferies 2019
2 0 1 9 ES T I M AT ES
EUR Million 2019 2018 Actual
Contract manufacturing and other 10 11
Products manufacturing 26 28
Royalties 10 15
Licence fee, up-front fees and milestones 1 6
U.S. sales 13 6
Total Revenues 60 66
Operating Expenses* (72) (83)
Operating loss** (12) (17)
*Of which ESOP expenses € 7.0m in FY 19 and € 9.0m in FY 18
**Excludes share of result of Cassiopea
Cosmo Pharmaceuticals 34 Jefferies 2019THANK YOU Cosmo Pharmaceuticals 35 Presentation title goes here
Cosmo Pharmaceuticals NV Riverside II Sir John Rogerson’s Quay Dublin 2, Ireland media@cosmopharma.com Alessandro Della Cha , CEO adellacha@cosmopharma.com John Manieri, IR jmanieri@cosmopharma.com +353 1 817 03 70
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