Jefferies Global Health Care Conference · 2019. 11. 25. · Eleview GI Genius (EU) Rich development pipeline Stakes in other pharma companies: 45% Cassiopea 19.5% RedHill 8.2% Paion

Cosmo Pharmaceuticals

Jefferies

Global Health Care ConferenceLondon, 20 November 2019


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.

Jefferies Global Health Care Conference2


COSMO PHARMACEUTICALS NV IN A NUTSHELL

Market Cap

CHF 1.092 billion

Net Cash CHF 301 million

Value 45% Stake

in Cassiopea

CHF 187 million

Employees

245 Value 19.5% stake in

RedHill CHF 44 million

Value repurchased treasury

shares CHF 49 million

Jefferies Global Health Care Conference

1H 2019

Revenues

€21.5million

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COSMO IN A NUTSHELL

Providing solutions for colon diseases

3 marketed

therapeuticsLialda/Mezavant

Uceris/Cortiment

Aemcolo/RelaFalk

2 marketed

medtech products Eleview

GI Genius (EU)

Rich development

pipeline

Stakes in

other pharma

companies:45% Cassiopea

19.5% RedHill

8.2% Paion

2.6% Volition



COSMO PHARMACEUTICALS: THE GI SPECIALTY COMPANY

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.

Gi Genius

Lialda | Mezavant | Mesavantcol

CB-03-10

Uceris | Cortiment



COSMO: 2019 AS A TRANSFORM ATI ON AL YEAR

Following delay in MB MMX approval Cosmo has:

• Completely restructured its US business, generating savings of €17.5m

• Completed the acquisition of 100% of Linkverse, therefore owning 100% of the AI business

• Closed the worldwide AI distribution deal with Medtronic

• Closed the US, China and South America Eleview distribution deal with Medtronic

• Closed the Collaboration Agreement with Medtronic to strengthen cooperation in AI

• Licensed Aemcolo for the USA to RedHill Biopharma and acquired a 19.56% stake in the company




From the product pipeline standpoint Cosmo has:

• Filed the MB MMX Marketing AuthorizationApplication with the EMEA

• Filed the ByFavo (Remimazolam) NDA with the FDA (PDUFA April 5, 2020)

• Filed the CB-03-10 IND with the FDA

• Filed the protocol for the second phase III study for MB MMX with the FDA

• Further advanced the Aemcolo Phase II Study in IBS-D

• Promoted the start of three Investigator InitiatedPhase II Studies for Aemcolo in the US for Uncomplicated Diverticulitis, Minimal HepaticEncephalopathy and Small Bacterial Overgrowth(SIBO)




Further, Cassiopea (45% owned by Cosmo) has:

• Announced positive results from Phase III Acne Open-Label Safety Study Evaluating Winlevi®

• Announced Very Positive Phase II Twelve Months Results for Breezula®

• Filed Winlevi’s NDA with the FDA (PDUFA August 27, 2020)

• Started the Breezula Phase II POC in women



COSMO: STRATEGY GOING FORWARD

Following delay in approval of MB MMX in the US Cosmo has decided to shift strategy and thus to:

A) Enter into partnerships with

selective players in exchange of

equity stake and/or

milestones/royalties or combination

of both (Medtronic, RedHill)

B) Develop new products

opportunities with partners



As for Cassiopea, in line with the original plan and reason for spin-off, Cosmo intends to provide the necessary

financing (either equity or debt) until the approval of Winlevi

Cosmo has no long-term strategic objectives for Cassiopea, which is considered as a financial investment

that will be monetized in due course

Cosmo, upon this shift of strategy, will thoroughly reassess its need for cash in the medium term and consider options

for the eventual excess cash


COSMO: STRATEGY GOING FORWARD

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Cosmo Pharmaceuticals Jefferies Global Health Care Conference

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

MethyleneBlueLesion detection during

colonoscopy

CB-03-10Oral AR antagonist against

solid tumors

GI-GeniusLesion detection during

colonoscopy (US registration)

* Investigator Initiated Studies

COSMO DEVELOPMENT PIPEL INE

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THERAPEUTIC PRODUCTS

Cosmo Pharmaceuticals Jefferies Global Health Care Conference13


• 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


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 : PERFECTLY TAILORED FOR TRAVELERS ’ D IARRHE A 1 , 2

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“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)


AEMCOLO FOR TRAVELER S ’ DIARRHE A : NOW RECOMMENDEDBY THE INTERNAT IO N AL SOCIETY OF TRAVEL MEDICINE ( ISTM)

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Cosmo Pharmaceuticals Jefferies Global Health Care Conference

AEMCOLO FOR TRAVELER S ’ DIARRHE A : SUPPORTED BY THE FDA

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70M

Americans Travelling Abroad

46M

Visit Developing

Countries

Priority

targets

TRAVELERS ’ DIARRHE A IS A HUGE MARKET



TRAVELERS ’ DIARRHE A 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

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


• New formulation in ongoing multicenter Phase II clinical

trial in Europe for IBS-D

• Data expected: Q2 2020

• Further clinical development with Investigator Initiated

Studies:

• Minimal Hepatic Encephalopathy

• IND and study protocol accepted by FDA

• Study began in August

• Acute Uncomplicated Diverticulitis

• Protocol being finalized

• Small Intestine Bacterial Overgrowth (SIBO)

• Protocol under development


AEMCOLO – STRONG FUTURE THROUGH ADDIT ION AL INDICATI O NS

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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, launch

in Germany December, 1st

• Marketed by RedHill in US

• Leading Competition:

• US Sales of Xifaxan: US$1.3 billion

• Physicians perceive advantages vs Xifaxan

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THE REDHILL DEAL

• RedHill is a $250m mkt cap Israeli company with US operations (NASDAQ: RDHL)

• Run by a highly experienced GI management team

• Rich and interesting pipeline of proprietaryproducts

• Talicia for H pylori infection has just been approvedby the FDA

• RedHill is also developing RHB-104 againstCrohn’s disease (first phase III successfullycompleted)



THE REDHILL DEAL

Talicia just approved, has the potential to become a first-line therapy for H pylori

infection, which affects over 50% of the population worldwide and approximately

35%, or over 100 million people, in the U.S., with an estimated 2.5 million patients

treated annually in the US. H. pylori is classified as a Group I carcinogen by the

International Agency for Research on Cancer. It is the strongest risk factor for the

development of gastric cancer and a major risk factor for peptic ulcer disease and

gastric mucosa-associated lymphoid tissue (MALT) lymphoma.

Current standard-of-care therapies fail in approximately 25-40% of patients due to

growing resistance of H. pylori to clarithromycin and metronidazole, antibiotics

commonly used in standard combination therapies. Clarithromycin-resistant H. pylori

was formally categorized by the World Health Organization (WHO) as a pathogen

for which there is a high priority need to develop new treatment



THE REDHILL DEAL

• Outlicense of Aemcolo for the US

• Aemcolo will be promoted by a sales force of 40 reps as of now

and 140 reps as of February 2020

• Down-payment of $12m in RDHL ADS (listed on NASDAQ)

• Royalties in the high twenties including supply of product

• Regulatory and commercial milestones totalling additional $ 100m

• Take over by RedHill of all marketing activities, including digital

marketing

• Shift of development responsibilities and related costs

• Additional cash investment by Cosmo of $36.3m in RDHL ADS

• Total investment (cash + down-payment) $48.3m, equal to 19.5%

of the share capital of RDHL



Procedural sedation



• 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

US procedural sedation market only

US NDA FILED APRIL 2019

APPROVAL EXPECTED

APRIL 5 2020

BYFAVO ( REMIMAZOLAM ) MARKET OPPORTUNITY



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 protocol

• Confirmatory Phase III trial: Expected to begin Q2

2020



CB-03-10Oral AR antagonist against solid tumors



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 Q2 2020

CB-03-10

Interest from potential licensing partners



MEDTECH PRODUCT


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

• Japan distributor: EA Pharma

• 2018: US $11 million gross sales

• US sales by Medtronic started in mid September

• Medtronic will pay Cosmo 50% of sales executed in first year to already existing customers


OUR REVENUES ARE PROFIT – NET MARGIN 20%

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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

• To date 180 devices delivered to Medtronic for EU

deployment

• US registration trial expected to begin in Q4 2019

• US sales: Expected in H2 2020 following FDA approval

THE AI PARTNERSHIP WITH MEDTRONIC – OUR REVENUES ARE PROFITS



GI GENIUS PRODUCT OUTLOOK



GI GENIUS IN PLAY

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GI GENIUS MARKET OPPORTUNITY


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

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THANK YOU

Cosmo Pharmaceuticals NV

Riverside II

Sir John Rogerson’s Quay

Dublin 2, Ireland

[email protected]

Mr. Alessandro Della Cha , CEO

[email protected]

Mr. Niall Donnelly, CFO

[email protected]


mailto:[email protected]



Documents

Jefferies Global Health Care Conference · 2019. 11. 25. · Eleview GI Genius (EU) Rich development pipeline Stakes in other pharma companies: 45% Cassiopea 19.5% RedHill 8.2% Paion