Cosmo Investor Presentation July2019/media/files/c/cosmo... · 2019. 7. 9. · Cosmo Pharmaceuticals COSMO PHARMACEUTICALS NV (COPN.SW) 3 Market Cap CHF1.48 billion Net Cash CHF360million

Cosmo Pharmaceuticals 1

Investor PresentationJuly 2019

Cosmo Pharmaceuticals

SAFE HARBOUR

This presentation may include forward-looking statements that are based on our management’s beliefs andassumptions and on information currently available to our management.The inclusion of forward-looking statements should not be regarded as a representation by Cosmo that any ofits plans will be achieved. Actual results may differ materially from those set forth in this presentation due to therisks and uncertainties inherent in Cosmo’s ability to develop and expand its business, successfully completedevelopment of its current product candidates and current and future collaborations for the development andcommercialization of its product candidates and reduce costs (including staff costs), the market for drugs to treatIBD diseases, Cosmo’s anticipated future revenues, capital expenditures and financial resources and othersimilar statements, may be “forward-looking” and as such involve risks and uncertainties and risks related to thecollaboration between Partners and Cosmo, including the potential for delays in the development programs forits products. No assurance can be given that the results anticipated in such forward looking statements willoccur. Actual events or results may differ materially from Cosmo’s expectations due to factors which include, butare not limited to, increased competition, Cosmo’s ability to finance expansion plans, the results of Cosmo’sresearch and development activities, the success of Cosmo’s products, regulatory, legislative and judicialdevelopments or changes in market and/or overall economic conditions. Cosmo assumes no responsibility toupdate forward-looking statements or to adapt them to future events or developments.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of thedate hereof, and Cosmo undertakes no obligation to revise or update this presentation.

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COSMO PHARMACEUTICALS NV (COPN.SW)

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Market CapCHF1.48 billion

Net Cash CHF360 million (€ 324 m at June 30, 2019) 2018

Revenues€66 million

Value 45% Stake in Cassiopea

CHF202 million

Employees279

No debt


COSMO PHARMACEUTICALS: THE GI SPECIALTY COMPANY

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Cosmo is an organization focused on improving treatment of colon diseases. Cosmo leverages its knowledge and relationships with the medical community to create shareholder value while reducing overall risks.


3 marketed therapeuticsLialda/MezavantUceris/Cortiment

Aemcolo/RelaFalk 2 marketed medtech products

EleviewGI Genius (EU)

Rich development pipeline

Stakes in other pharma companies:45% Cassiopea8.2% Paion2.6% Volition

Providing solutions for colon diseasesCOSMO IN A NUTSHELL


COSMO DEVELOPMENT PIPELINE

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PRODUCT INDICATION PH I PH II PH III

Aemcolo IBS-D

Acute Uncomplicated Diverticulitis*

Small Intestine BacteriaI Overgrowth (SIBO)*

Minimal Hepatic Encephalopathy*

Byfavo Procedural Sedation

MethyleneBlue Lesion detection during colonoscopy

CB-03-10 Oral AR antagonist against solid tumors

GI-Genius Lesion detection during colonoscopy (US registration)

* Investigator Initiated Studies


AemcoloTraveler’s diarrhea

Digital launch Germany launch by Falk

Launch in other EU countries

GI GeniusAI-enhanced endoscopy aid software

Start US registration trial

Medtronicpresenting at UEGW Barcelona

EU marketing trial

FDA Approval Medtronic presenting at DDW Chicago

VALUE INFLECTION EVENTS

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Aemcolo• Acute Uncomplicated

Diverticulitis• SIBO• Minimal Hepatic

Encephalopathy

Beginning of the Phase II study for Minimal Hepatic Encephalopathy

Beginning of the Phase II studies for Acute Uncomplicated Diverticulitis and SIBO

AemcoloIBS-D

Top-line results IBS-D trial

ByfavoProcedural sedation

April 5 FDA PDUFA

MethyleneBlueLesion detection during colonoscopy

Protocol discussion 2nd

pivotal trial

Approval Canadian PDUFA

FDA meeting to discuss new protocol

Start new trial

EMEA approval

CB-03-10Oral AR antagonist against solid tumors

Begin Phase I End Phase I

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PERFORMANCE OF OUR MARKETED PRODUCTS IN 2018

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Lialda | MezavantMesavancol

Revenue: €20.7 million; €4.5 million decrease due to generic version launch in the US March

2018 Cortiment

Manufacturing and royalty revenue: €3.9 million

Net Sales by Ferring: €15.1 million

EleviewRevenue: €6.8 million

UcerisRevenue: €17.5 million;

€8.2 million decrease due to generic version launch July 2018

Net sales by Valeant: US$ 96.7 million


THERAPEUTIC PRODUCTS

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AEMCOLO: PERFECTLY TAILORED FOR TRAVELERS’ DIARRHEA1,2

• Non-systemic, minimally absorbed

• MMX® delivery to the colon

• Proven efficacy against E. coli

• Reliable safety and tolerability

• Simple BID dosing

• No increase in ESBL-E colonization

rates/lower risk of acquisition

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AEMCOLO OFFERS A CURE TO TRAVELERS’ DIARRHEA

ELIMINATING THE SHORTCOMINGS OF OTHER

TREATMENTS

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


AEMCOLO FOR TRAVELERS’ DIARRHEA: NOW RECOMMENDED BY THE INTERNATIONAL SOCIETY OF TRAVEL MEDICINE (ISTM)

“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.” – International Society of Travel Medicine (ISTM)

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AEMCOLO FOR TRAVELERS’ DIARRHEA: SUPPORTED BY THE FDA

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8.7 billion minutes (+41% Y/Y)spent on digital travel content in the US

TOTAL US INTERNET MINUTES GREW BY 7% Y/Y

>36% are seeking health advicebefore they leave1

70MAmericans Travelling Abroad

46MVisit Developing

Countries

Prioritytargets

1 – “Travel Health, Knowledge, Attitudes and Practices among United States Travelers.” J Travel Med 2004; 11:23–26.

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TRAVELERS’ DIARRHEA IS A HUGE MARKET


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

TRAVELERS’ DIARRHEA IS A HUGE MARKET

https://www.aarp.org/content/dam/aarp/research/surveys_statistics/life-leisure/2017/2018-travel-trends.doi.10.26419-2Fres.00179.001.pdf


TRENDS IN HEALTHCARE

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>95% of community pharmacies do e-prescribing


TRAVELERS’ DIARRHEA: HOW TO CAPTURE THE OPPORTUNITY

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Strategy: Target travel planners directly via digital marketing

46 million Americans travel EVERY YEAR to at risk

countries where the ISTM recommends bringing an antibiotic

with them


Cosmo US commercial organization has direct experience in GI, consumer health/ marketing, digital marketing

TRAVELERS’ DIARRHEA: HOW TO CAPTURE THE OPPORTUNITYLEVERAGE EXPERIENCE & BRING ON BOARD The well known players in the field

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• Experienced marketing partner• Direct experience in Travelers’ health• Strong international team

Strong marketing partner

• End to end provider – telemedicine through to warehousing, pharmacy dispensing, and home delivery

Strong execution partner


AEMCOLO BUSINESS MODEL WITH US TRAVELERS

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TelemedicineProvider

AEMCOLO WEBSITE

THE BUSINESS MODEL TAPS INTO KEY POINTS OF INFLUENCE, AND LEVERAGES NEW TECHNOLOGIES/BUSINESS MODELS TO PROVIDE EASIER ACCESS TO TRAVELERS

Link to telemedicine provider

CONDITION, PRODUCT AND PRESCRIBING INFORMATION

Online DTC MARKETING Limited HCP

Online consultation

with HCPe-Rx HOME DELIVERY

OF AEMCOLO

Increase Traveler awareness and perception of risk to drive traffic to the website


AEMCOLO BUSINESS MODEL WITH TRAVELERS: BENEFITS

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

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AEMCOLO – STRONG FUTURE THROUGH ADDITIONAL INDICATIONS

• New formulation in ongoing multicenter Phase II clinical trial in Europe for IBS-D• Data expected: Q2 2020

• Further clinical development with Investigator InitiatedStudies: • 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

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AEMCOLO – OVERALL MARKET OPPORTUNITY

• Aemcolo:

• US FDA Approval for Travelers’ Diarrhea Nov. 2018

• Aemcolo US Market Opportunity at least $1 billion

• Estimated market share: 20-25%

• Estimated peak sales: US$200 - 250 million

• Estimated time to peak sales: 7 - 8 years

• Marketed by Dr.Falk in Australia and Europe

• Leading Competition:

• US Sales of Xifaxan: US$1.3 billion

• Physicians perceive advantages vs Xifaxan

22Cosmo Pharmaceuticals


Procedural sedation


BYFAVO (Remimazolam) MARKET OPPORTUNITY

• Annual US colonoscopies, upper GI endoscopies

and bronchoscopies: 24.5 million

• 90% of US colonoscopies, upper GI endoscopies

and bronchoscopies used moderate sedation

• Estimated market opportunity in procedural

sedation: US$600 million

• Estimated peak sales in procedural sedation:

US$150 - 200 million

• Estimated time to peak sales: 5 - 7 years

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US NDA FILED APRIL 2019 APPROVAL EXPECTED APRIL 2020

US procedural sedation market only


Lesion detection during colonoscopy


METHYLENE BLUE MMX – US MARKET OPPORTUNITY

• 16 million US colonoscopies annually, 74% colorectal cancer related

• 12 million U.S. colorectal cancer related colonoscopies

• 31% colonoscopies in IBD patients/high risk patients• Estimated Market Opportunity: US$3 billion • Estimated peak sales: US$600 - $700 million• Estimated time line to peak sales: 7 - 8 years• Outstanding results from first phase III trial• Next steps: Ongoing discussions with FDA re

additional Phase III trial • Confirmatory Phase III trial: Expected to begin Q1

2020


CB-03-10Oral AR antagonist against solid tumors


CB-03-10 PHASE 1 READY ANDROGEN RECEPTOR ANTAGONIST FOR SOLID TUMORS

Several Cosmo Pharmaceuticals compounds derived from cortexolone were screened as potential treatment for diseases dependent on the androgen receptor For acne treatment (Winlevi)

For alopecia treatment (Breezula)

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For treatment of solid tumors

CB-03-10 was selected from a compound library owned by Cosmo Pharmaceuticals

Clascoterone

CB-03-10


CB-03-10 IS A POTENT ANTAGONIST OF THE ANDROGEN RECEPTOR WITH ANTI-TUMOR ACTIVITY

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In vivo treatment of human prostate cancer (LNCap) implanted in the mouse

Tissue Type Cell Line Name CB-03-10 Enza Gemcitabine

Paclitaxel

In Vitro Citoxicity IC50

Prostate CancerLNCaP 10 50

LNCaP EnzaR 13 123

Pancreatic CancerPanc1 38 125

MiaPac2 23 56 17

Breast CancerMCF7 82 146

TNBCMDA-MB-231 55 130 0.028

Colon Cancer HT29 14 150


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 authorized by the FDA

Phase 1 clinical trial scheduled to begin Q4 2019

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CB-03-10 SUMMARY

Interest from potential licensing partners


MEDTECH PRODUCT

Presentation title goes here31


Submucosal injectable solution


ELEVIEW – MARKET OPPORTUNITY

• 16 million 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. 3 million• Average 1.5 vial per removal: total 4.5 million vials• Current price: US$81 per vial• Market Opportunity approx.: US$350 million• Estimated peak sales: US$65 - 75 million (20% of market)• Time to peak sales: 7 - 8 years• US, China, South America distributor: Medtronic• Europe, Asia distributor: FujiFilm• Japan distributor: EA Pharma• 2018: US $11 million gross sales

OUR REVENUES ARE PROFIT – NET MARGIN 20%


GI GENIUSAI-enhanced endoscopy aid software


GI GENIUS

• Global Distributor: Medtronic• GI Genius devices currently being deployed with EU KOLs to

prepare commercial launch• EU sales: Starting in H2 2019• US registration trial expected to begin in Q3 2019• US sales: Expected in H1 2020 following FDA approval

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THE AI PARTNERSHIP WITH MEDTRONIC – OUR REVENUES ARE PROFITS


GI GENIUS PRODUCT OUTLOOK

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GI GENIUS IN PLAY

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https://www.youtube.com/watch?v=AblniEzEgtY


GI GENIUS MARKET OPPORTUNITY

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Medtronic established business model: User

fees

Estimated initial yearly fee per endoscopy

tower US/EU: US$/€36,000

Estimated net margin for Cosmo expected

above 20%

Estimated n. of endoscopy towers in

US: 20,000


FINANCIAL OUTLOOK



2019 ESTIMATES

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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


THANK YOU


Cosmo Pharmaceuticals NVRiverside IISir John Rogerson’s Quay Dublin 2, [email protected]

Mr. Alessandro Della Cha , [email protected]

Mr. John Manieri, [email protected]+353 1 817 03 70

mailto:[email protected]



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Cosmo Investor Presentation July2019/media/files/c/cosmo... · 2019. 7. 9. · Cosmo Pharmaceuticals COSMO PHARMACEUTICALS NV (COPN.SW) 3 Market Cap CHF1.48 billion Net Cash CHF360million