credit suisse small & mid cap conference

Cosmo Pharmaceuticals

Credit SuisseSmall & Mid Cap Conference

Zurich, 13 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.

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COSMO PHARMACEUTICALS NV IN A NUTSHELL

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Market CapCHF 1.092 billion

Net Cash CHF 301 million

Value 45% Stake in Cassiopea

CHF 187 million

Employees245 Value 19.5 stake in RedHill

CHF 44 millionValue repurchased treasury shares CHF 49 million

Credit Suisse Conference 2019

1H 2019Revenues

€21.5million


COSMO IN A NUTSHELL

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Providing solutions for colon diseases

3 marketed therapeuticsLialda/MezavantUceris/Cortiment

Aemcolo/RelaFalk2 marketed

medtech products Eleview

GI Genius (EU)

Rich development pipeline

Stakes in other pharma companies:45% Cassiopea19.5% RedHill8.2% Paion2.6% Volition



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.

Gi Genius

Lialda | Mezavant | Mesavantcol

CB-03-10

Uceris | Cortiment



C O SM O : 2019 A S A TRANSFORMATIONAL YEAR

Following delay in MB MMX approval Cosmo has:

• Completely restructured its US business, generatingsavings of € 17.5

• 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



C O SM O : 2019 A S A TRANSFORMATIONAL YEA R

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 Initiated

Phase II Studies for Aemcolo in the US for Uncomplicated Diverticulitis, Minimal HepaticEncephalopathy and Small Bacterial Overgrowth(SIBO)

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C O SM O : 2019 A S A TRANSFORMATIONAL YEA R

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



C O SM O : ST R AT EG Y GOING FORWARD

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

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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 cash10 Credit Suisse Conference 2019

C O SM O : ST R AT EG Y GOING FORWARD

Cosmo Pharmaceuticals Credit Suisse Conference 201911

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

C O SM O D EVEL O PM EN T PIPEL IN E


THERAPEUTIC PRODUCTS

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Cosmo Pharmaceuticals 13


• 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

A EM C O L O : PER FEC TLY TAILORED FOR TRAVELERS’ D IA R R H EA 1, 2


“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)


A EM C O L O FOR TRAVELERS’ D I A R R H EA : N O W R EC O M M EN D EDB Y T H E INTERNATIONAL SOC IETY OF TRAVEL M ED IC IN E ( IST M )

Cosmo Pharmaceuticals 16 Credit Suisse Conference 2019

A EM C O L O FOR TRAVELERS’ D I A R R H EA : SU PPOR TED B Y T H E F D A


70MAmericans Travelling Abroad

46MVisit Developing

Countries

Prioritytargets

TRAVE LERS’ D I A R R H EA IS A H U G E M A R K ET



TRAVELERS’ D I A R R H EA IS A H U G E M A R K ET


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

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 InitiatedStudies: • 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


A EM C O L O – STR ON G FU TU R E THROUGH A D D I T I O N A L INDICAT IONS


A EM C O L O – OVERALL M ARKET 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, launchin 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 R ED H I L L D EA L

• 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 proprietary

products• Talicia for H pylori infection has just been approved

by the FDA• RedHill is also developing RHB-104 against

Crohn’s disease (first phase III successfullycompleted)




Talicia just approved, has the potential to become a first-line therapy for H pyloriinfection, 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. pyloriwas formally categorized by the World Health Organization (WHO) as a pathogen for which there is a high priority need to develop new treatment




• 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

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US procedural sedation market only

US NDA FILED APRIL 2019 APPROVAL EXPECTED APRIL 5 2020

B YFAVO ( R EM I M A Z O L A M ) M A R K ET OPPOR T U N IT Y



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

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CB-03-10

Interest from potential licensing partners



MEDTECH PRODUCT

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Submucosal injectable solution


ELEVIEW – M A R K ET 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%


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

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THE AI PARTNERSHIP WITH MEDTRONIC – OUR REVENUES ARE PROFITS



GI GENIUS PRODUCT OUTLOOK



GI GENIUS M ARKET 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


THANK YOU

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

Mr. Alessandro Della Cha , [email protected]

Mr. Niall Donnelly, [email protected]

mailto:[email protected]



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