cosmo investor presentation july2019/media/files/c/cosmo... · 2019. 7. 9. · cosmo...
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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
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
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.
Cosmo Pharmaceuticals 5
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 Pharmaceuticals
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
Cosmo Pharmaceuticals
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
19Q3 19Q4 20Q1 20Q2 20Q3 20Q4
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Cosmo Pharmaceuticals
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
Cosmo Pharmaceuticals
THERAPEUTIC PRODUCTS
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Cosmo Pharmaceuticals 10
Cosmo Pharmaceuticals
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
Cosmo Pharmaceuticals
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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Cosmo Pharmaceuticals
AEMCOLO FOR TRAVELERS’ DIARRHEA: SUPPORTED BY THE FDA
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Cosmo Pharmaceuticals
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
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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
Cosmo Pharmaceuticals
TRENDS IN HEALTHCARE
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>95% of community pharmacies do e-prescribing
Cosmo Pharmaceuticals
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 Pharmaceuticals
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
Cosmo Pharmaceuticals
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
Cosmo Pharmaceuticals
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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Cosmo Pharmaceuticals
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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Cosmo Pharmaceuticals
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
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Procedural sedation
Cosmo Pharmaceuticals
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
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Lesion detection during colonoscopy
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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
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CB-03-10Oral AR antagonist against solid tumors
Cosmo Pharmaceuticals
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
Cosmo Pharmaceuticals
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
Cosmo Pharmaceuticals
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
Cosmo Pharmaceuticals
MEDTECH PRODUCT
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Cosmo Pharmaceuticals 32
Submucosal injectable solution
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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 $11 million gross sales
OUR REVENUES ARE PROFIT – NET MARGIN 20%
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GI GENIUSAI-enhanced endoscopy aid software
Cosmo Pharmaceuticals
GI GENIUS
• Global Distributor: Medtronic• GI Genius devices currently being deployed with EU KOLs to
prepare commercial launch• EU sales: Starting in H2 2019• US registration trial expected to begin in Q3 2019• US sales: Expected in H1 2020 following FDA approval
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THE AI PARTNERSHIP WITH MEDTRONIC – OUR REVENUES ARE PROFITS
Cosmo Pharmaceuticals
GI GENIUS PRODUCT OUTLOOK
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Cosmo Pharmaceuticals
GI GENIUS MARKET OPPORTUNITY
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Medtronic established business model: User
fees
Estimated initial yearly fee per endoscopy
tower US/EU: US$/€36,000
Estimated net margin for Cosmo expected
above 20%
Estimated n. of endoscopy towers in
US: 20,000
Cosmo Pharmaceuticals
FINANCIAL OUTLOOK
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Cosmo Pharmaceuticals
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
Cosmo Pharmaceuticals
THANK YOU
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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