report on 2014/media/files/c/cosmo...2 – eu trial (non inferiority vs. cypro) ongoing trial begun...

Report on 2014

Zurich - March 25, 2015

1

2

Safe HarbourThis presentation may include forward-looking statements that are based on our

management’s beliefs and assumptions 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 of its plans will be achieved. Actual results may

differ materially from those set forth in this presentation due to the risks and

uncertainties inherent in Cosmo’s ability to develop and expand its business,

successfully complete development of its current product candidates and current and

future collaborations for the development and commercialisation of its product

candidates and reduce costs (including staff costs), the market for drugs to treat IBD

diseases, Cosmo’s anticipated future revenues, capital expenditures and financial

resources and other similar statements, may be "forward-looking" and as such involve

risks and uncertainties and risks related to the collaboration between Partners and

Cosmo, including the potential for delays in the development programs for Methylene

Blue MMX®, Rifamycin SV MMX®, and CB-03-01. No assurance can be given that the

results anticipated in such forward looking statements will occur. Actual events or

results may differ materially from Cosmo’s expectations due to factors which include,

but are not limited to, increased competition, Cosmo’s ability to finance expansion

plans, the results of Cosmo’s research and development activities, the success of

Cosmo’s products, regulatory, legislative and judicial developments or changes in

market and/or overall economic conditions. Cosmo assumes no responsibility to

update 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 the date hereof, and Cosmo undertakes no obligation to revise

or update this presentation.

3

Agenda

• Introduction and 2014 highlights Alessandro Della Cha’, CEO

• 2014 Financial review Chris Tanner, CFO

• Pipeline update Luigi Moro, CSO

• 2015 Outlook Alessandro Della Cha’, CEO

• Questions & Answers All

4

2014 Highlights

• Operating revenues increased by 41.2% to € 79.6 million

• Pre tax profit increased by 51.9% to €108.9 million

• Sale of the remaining Santarus shares for a gain of € 65.1 million

• Profit after tax increased by 6.7% to €73.3 million;

• Tax expenses increased substantially to €35.5 million of which €25.3 million were

one time taxes for the change of seat to Luxembourg

• Uceris® sales were greater than $ 150 million an increase of more than120%

• Excellent market performance of Lialda® in USA. Fastest growing UC tablet,33% share in 5- ASA market

• 6 clinical trials ongoing

• Development of SIC 8000, a novel composition for submucosal injections

• CB-03-01 license regained and FDA phase II meeting completed withsuccessful outcome

5

Income Statement

EUR/1,000 31.12.2014 31.12.2013

Revenues 79,593 56,368

Other Income 51 1,024

Cost of sales (21,540) (19,162)

Research and development costs (19,216) (17,602)

Selling, general and administrative costs (16,674) (7,690)

Net Operating expenses (57,379) (43,430)

Operating Result 22,214 12,938

Financial income 71,773 59,912

Financial expenses (2,194) (1,179)

Termination fee 17,058 -

Profit Before Taxes 108,851 71,671

Income tax expenses (35,529) (2,938)

Profit For The Year 73,322 68,733

6

Income Statement in detail

• Overall operating revenue increased 41.2% to €79.6 million

• Recurring revenues increased by 21.0% to € 61.9 million

• Royalties increased by 3.2% to € 21.1 million

• Manufacturing of MMX based products increased by 48.8% to €29.1million

• Other contract drug manufacturing increased by 5.7% to €11.0 million

• One time license fees and milestones increased by 237.8% to €17.7million

• Operating costs increased by 32.1% to €57.4 million

• Cost of sales increased by 12.4% to €21.5 million

• SG&A increased by 116.8% to €16.7 million

• R&D expenditures increased by 9.2% to €19.2 million

• EBITDA increased by 42.0% to €31.0 million

• Profit after tax increased by 6.7% to €73.3 million

• Taxes increased to €35.5 million of which €25.3 million were related tochange of seat to Luxembourg

7

Consolidated Statement of Financial Position

EUR/1,000 31.12.2014 31.12.2013

Non current financial assets available for sale 120,826 15,513

Other non current assets 34,086 39,160

Current financial assets available for sale 25,326 121,823

Cash, cash equivalents 34,138 46,338

Other current assets 11,245 20,170

Total assets 225,621 243,004

Medium-to long-term interest-bearing loans and borrowings 8,930 9,762

Other non-current liabilities 3,746 3,388

Short-term interest-bearing loans and borrowings 2,000 1,986

Other current liabilities 58,656 7,713

Equity attributable to owners of the company 152,276 220,140

Non controlling interest 13 15

Total equity and liabilities 225,621 243,004

8

Discussion of Statement of Financial Position

• 78.1% of total assets of are cash & liquid financial assets ie €176,2 million

• 30% of these are invested in US$, 70% in €

• Intangible assets declined by 37.0% to €10.3 million due to depreciationof capitalized development cost of Budesonide MMX®

• Total liabilities increased by € 50.5m or 220.9% to € 73.3m

• Current tax liabilities increased by € 32.3m of which € 25.3 m are the exit tax

• Other current liabilities increased by € 17.3m mainly for the payables to withdrawing shareholders (104,931 shares at the price of CHF 156.03 for each share for a total of € 13.6m).

• Equity declined by 30.8% to €152.3 million

• Dividend of €14.3 million paid out in 2014

• 753’805 shares repurchased for total €65.7 million

• 576’760 shares cancelled

• Treasury share stock of 213’383

• 67.5% of total Assets financed by Equity, a decline from 90.6%

9

2014 Cash Flow

Cash at the end of the period 34,138

Purchase of treasury shares (52,126)

Dividends paid (14,255)

Additional investment in Cosmo R&D interests (5)

Loan repayment (net of increase) (738)

Disposal of financial assets available for sales 123,111Investment in fixed assets (net) (2,159)

Investment in intangibles assets (305)

Investment in financial assets available for sales (132,170)Change in working capital 12,452

Accrual/payment of employee benefits, other

provision and taxes (407)

Income taxes paid (1,270)

Other non cash items 3,146

Financial gain on sale of financial assets available for

sale (Santarus shares) (65,089)

Depreciation and amortization 8,764

Profit before taxes 108,851

Cash at the beginning of the period 46,338

(140,000) (120,000) (100,000) (80,000) (60,000) (40,000) (20,000) 0 20,000 40,000 60,000 80,000 100,000 120,000 140,000

10

Products on the market

GI

11

Lialda®/Mezavant®/Mesavancol®

• Indication

• Induction and maintenance of Remission for Patients with UlcerativeColitis of mild to moderate severity

• Net Sales of Lialda ®/Mezavant®

• 2013: $ 529 m (+32.3%)

• 2014: $ 633 m (+19.7%)

• US Market share

• 2013: 29%

• 2014: 33% (biggest individual 5ASA product)

• Cosmo Income

• 2013 €28.8 m; € 14.5 m royalties and € 14.3 m manufacturing

• 2014: €22.8 m; € 6.3 m royalties, € 16.5 m manufacturing

12

Uceris®/Cortiment®

• Indication

• Induction of Remission for Patients with active Ulcerative Colitis ofmild to moderate severity

• Net Sales

• 2013: $ 66.3 m

• 2014: >$ 150 m

• Cosmo Income

• 2013: € 16.5 m (royalties of € 5.9 m; milestones of € 5.3 m;manufacturing revenues of € 5.3 m)

• 2014: € 45.0 m (royalties of €14.8 m; milestones of €17.7 m;manufacturing revenues of €12.5 m)

13

Cortiment: RoW approval path

Cortiment marketing authorization application (MAA) already submitted in :

• Australia• Israel/Jordan/Kuwait/Lebanon• Brazil• South Africa• Russia• Mexico

Submissions in CH, Turkey, UAE, Chile, Canada to follow

Expected approvals in 2015:• Australia• Israel/Lebanon• Jordan/Kuwait• Russia

• Mexico

14

Cosmo‘s distinct path to organic growth

1) Expand GI pipeline

2) Expand activities to other therapeutic areas

3) Willingness for “equity for product” deals

4) Create as much value as possible in-house and enter deals when value maximization and risk reduction can be achieved

15

Products under development

GI Pipeline

16

GI Pipeline - Rifamycin

NCE (in US) antibiotic with negligible absorption after oral administrationand lower possibility of resistance. Candidate for 10 years exclusivityin USA under GAIN Act

Indication currently sought: Travellers’ Diarrhoea

Clinical status:

Two pivotal clinical trials were required to support registration:

1 – US trial (superiority vs. placebo) completed successfully in LatAm

2 – EU trial (non inferiority vs. Cypro) ongoingTrial begun in India by Falk. After 800 patients, due to unexpected localregulatory issues affecting all clinical trials the trial was put on hold. Falk has now moved the trial in LatAm (Mexico, Perù, Guatemala and Ecuador)

Development Timeline: NDA filing set for 1Q 2016

17

GI Pipeline – Rifamycin subsequent indications

Uncomplicated Diverticulitis

• Phase II managed by Falk in Germany, Italy, Hungary and Romania.

• approximately 100 patients enrolled.

• expansion to other two countries ongoing.

Development timeline: interim analysis by end of 2015

IBS

• New formulation containing 600mg/tablet already developed aiming at

better patients compliance

• Seeking an earlier API delivery in the small intestine and colon

Development Timeline: Phase I/II to start in 1Q 15

18

GI Pipeline - MoAb

Monoclonal antibody MMX

• Proven preservation of Infliximab antibody activity in tabletsand in colonic environment

• Currently developing clinical model in mice

• Bio-similar API (Bio-better since not injected) underdevelopment

• API manufacturing scale up process ongoing

• Phase I/II trial to begin in 2015

• Potential indication: Ulcerative Colitis (maintenance)

19

Expansion into new therapeutic areas

Endoscopy

Dermatology

20

Endoscopy Pipeline

Two new powerful tools to support endoscopistsin their battle against colon cancer

Methylene Blue MMX® SIC 8000

21

Endoscopy Pipeline - Methylene Blue MMX (MB)

Methylene Blue is used in > 10% colonoscopies

via “in situ” spraying onto the colonic mucosa

*ASGE Volume 66, No 4: 2007 GASTROENINTESINAL ENDOSCOPY. Clinical Trial showed increased detection rate with Indigo Carmine.

2-3 fold increased procedure time*[~80$ cost of single use spray catheter]

Localized and partial staining*

Suspicious area according to endoscopistsurvey

Increased Detection Rate in the area*

22

Endoscopy Pipeline - MB

MB: a revolutionary diagnostic tool for early cancer detection

* According to Phase II Clinical Data, 51% more polyps and47% more adenomas were found with MB

Normal Procedure

Time

Whole Colon stained,

overcoming operator

subjectivity

Sharp increase in Detection Rate,

especially for flat/small lesions*

MB Main TargetPolyps not otherwise

visible

INVISIBLE WITHOUT

MB

26

Endoscopy Pipeline - MB development timeline

• Phase III ongoing, expanded from 13 sites between US and EU to 20

• Primary endpoint: proportion of subjects with at least one histologically proven adenoma or carcinoma vs. white light endoscopy

• 1,270 patients to be treated within H1 2015

• Data available Q3 2015

• Centralized Registration Application granted in EU under EMA

• Special Protocol Assessment (SPA) granted by FDA

27

Cost of colonoscopies in the US

MB Market potential 2017 2018 2019 2020 2021

non SSRI colonoscopies in US in m 12.6 12.8 12.9 13.1 13.2

market penetration 5% 10% 15% 20% 20%

minimum price 120 120 120 120 120

colonoscopies in EU 17.4 17.6 17.8 18.0 18.3

market penetration 5% 10% 15% 20% 20%

minimum price 50 50 50 50 50

colonoscopies in RoW 24.8 26.8 29.0 31.5 34.2

market penetration 0% 2,5% 5,0% 7,5% 10,0%

minimum price 30 30 30 30 30

total revenues in EUR m 119.1 261.2 409.6 564.8 602.4

28

Endoscopy PipelineMB market potential estimate

Endoscopy Pipeline - SIC

29

After the lesion isfound, it must be

removed

Endoscopy Pipeline - SICPolyps removal tecniques

Endoscopic Mucosal Resection (EMR)

30

• Most commonly used technique for the removal of mucosal lesions, smaller than 2 cm, or piecemeal removal of larger lesions (> 2 cm)

• A cushion is needed to lift the lesion and facilitate its removal, minimizing the risks of mechanical or electrocutlery damage to the deep layers of the GI wall

Injection in the submucosa

Capture with the snare

Removal

Endoscopy Pipeline – SIC Polyps removal tecniques

Endoscopic Submucosal Dissection (ESD)

31

Circumferential injections Mucosal elevation Submucosal dissection

• Developed specifically for removing larger lesions (> 2 cm)

• Predicted to replace conventional surgery

• Higher rate of perforation and bleeding complications

• Submucosal injection is essential in ESD, and a high and long lasting submucosal cushion is needed for a safe cutting


32

• To avoid risk of perforation, particularly for flat polyps, endoscopists needto create a ’’safety cushion‘‘ between the lesion and the deep layers of the GI wall

• Current procedures foresee the injection of normal saline solution, which is easy to inject but dissipates quickly

• Longer lasting cushions are obtained with expensive Hyaluronic Acid solutions or self made cocktails

• Strong need to obtain similar long lasting effect with alternative solutions: ideal product should:

• have low viscosity to facilitate injection

• Provide a long lasting cushion (> 30 min)

• Include a dye to enhance borders definition

• be safe and bio-compatible

• Affordable in terms of pricing

33

• SIC 8000 (SIC) is a Submucosal Injectable Composition, easy to be injected, developed to be used in endoscopic resection procedures in the GI tract

• SIC creates a long lasting cushion which is essential for a successful Endoscopic Mucosal Resection (EMR) or Endoscopic SubmucosalDissection (ESD)

• SIC is dyed with methylene blue, so it helps in visualizing the lesion and performing the resection procedure, minimizing risk of perforation

• SIC is covered by two international and one US patent applications filed in 2014 (priority 2013)


Endoscopy Pipeline - SICSIC satisfies an unmet need

34

• No products for this indication currently available in the US market

• Most commonly used submucosal injectable solution is normal saline, but several injections needed to maintain the cushion

• Hyaluronic acid solutions are known to be long lasting, but expensive Sigmavisc® in EU costs 50€ for 5 ml, Muco-up® in Japan costs 55€ for 5 ml

• Other patented compositions not on US market for impracticality

• Easy to use: no additional or customized devices (such as syringe pumps or other pumps) needed to administer SIC 8000

No currently used solutions meet medical needsin endoscopic practice

35

Endoscopy Pipeline – SICDevelopment as agreed with FDA is completed

• 3 biocompatibility studies (as per ISO 10993 standard)

• In vitro cytotoxicity

• Acute intracutaneous reactivity study in rabbits

• Delayed dermal sensitization in guinea pigs

• Biocompatibility studies demonstrated that SIC 8000 is biocompatible: not

cytotoxic, not irritating, not sensitizing

• 5 preclinical GLP studies on animals:

• Tolerability study in minipigs

• Tolerability study in dogs

• Tolerability study in pigs

• EMR/ESD procedures using SIC 8000 in pigs (stomach + colon)

• Feasibility study of EMR/ESD procedures in pigs (stomach + colon + esophagus)

• Aim of the preclinical studies: full characterization of the product (efficacy/safety

profile) in conditions simulating and mimicking the actual use of the product on

human patients

• Animal species selection based on the animal models currently used for endoscopic

training procedures

36

Endoscopy Pipeline - SICDevelopment Timeline

SIC is a medical device classified as a class II medical device in US and as either a class IIa or IIb medical device in EU

Approval timeline:

• 510(k) filing in US scheduled by end Q1 2015

• FDA approval scheduled by end Q2 2015

• European CE mark filing scheduled by Q2 2015

• European approval scheduled by Q4 2015

SIC market estimates 2016 2017 2018 2019 2020polyps/adenomas per colonoscopy in phase II 1,75 1,75 1,75 1,75 1,75 % of polyps/ adenomas removal requiring SIC 20% 20% 20% 20% 20%Minimum vials per colonoscopy 1,5 1,5 1,5 1,5 1,5

estimated price in US 100 100 100 100 100

market penetration in US 10% 20% 30% 40% 50%

estimated price in EU 40 40 40 40 40

market penetration in EU 7% 15% 25% 30% 30%

estimated price in RoW 30 30 30 30 30

market penetration 3,5% 7,5% 12,5% 15,0% 15,0%

Revenue (millions) 68,5 143,1 227,8 298,6 353,6

37

Endoscopy pipeline: SICmarket potential estimate (colonoscopies only)

38

Endoscopy pipeline: SICmarket potential (additional indications)

The tissues of the esophagus, stomach and duodenum are quite similar to those of the colon. Inspection of these three tracts is conducted by Esophagogastroduodenoscopy (ECG). SIC can be used in all these tracts.

As many ECGs are performed as colonoscopies, both in the US and Europe.

During ECG, removal of tissues/polyps is frequently necessary and will require SIC as per below examples:

Barrett Esophagus

• Caused by GERD, ~ 1,6% of population affected• Requires an ECG every 3 years• Tissue removal required in ~ 10% all cases

Stomach & duodenal polyps

• polyps requiring extraction are found in around 0,7% of all procedures

39

Cosmo Dermatology Pipeline

Introducing …

Product Pre-clinical Phase I Phase II Phase III MA Launch

WinleviACNE

BreezulaALOPECIA

CB-06-02AS 101

CB-06-04 ACNE ANTIBIOTIC

Cassiopea’s Dermatology pipeline

42

Dermatology: a market with little innovation and many

opportunities

• No NCE in Acne in the US market in the last 15 years

• Dermatologists generally prescribe 2-3 products at the same time as they look for new therapeutic options

• Historically dermatology has had the lowest product failure rate in clinical trials

• Probability of success in phase III clinical trials is high

• Market has important cosmetic and life-style implications

43

Cassiopea Dermatology Pipeline Acne market dynamics & opportunity

85% of all persons age 12-24 get acne, characterized as a chronic disease

In US 17 m person have acne, 35 m prescriptions are written p.a. primarily generics as there are no new drugs

WW market ~ $ 3 b; US Market at $ 2.3 b, growing by ~ 1% p.a.

• Topical antibiotics market share ~ 29%

• Topical retinoid market ~ 25%

• Oral antibiotic market ~ 41%

Excellent opportunity for new topical drugs withnovel treatment forms and very low side effects

44

Cassiopea Dermatology pipeline – Winlevi (Acne)

Winlevi (Cortexolone 17α-propionate) is a NCEwith a new mechanism of action, acting on thesebum secretion control.It can prevent the cascade of physiologicalevents:follicle closure by sebum overproduction ->colonization by Prop. acnes ->Inflammation that leads to Acne formation,through evidence ofComedones -> papules -> pustules -> nodules ->cysts

Differently from other Acne drugs, Winlevi istopically effective without systemic sideeffects (no relevant AEs detected on the >450subjects treated up today)

45

Cassiopea‘s Dermatology pipeline Winlevi (acne)

Phase II overview

Phase II dose ranging trial completed in US

360 patients – 4 doses + vehicle

Best dose identified (1% BID)

No adverse events

Cassiopea‘s Dermatology pipeline Winlevi (Acne)

Phase II overview

46

• Winlevi is a NCE

• FDA requires at least 1000 patients treated for safety evaluation

• 110 patients treated in Phase I/IIa

• 290 patients treated in Phase IIb

• Primary Endpoints: reached

• 700 treated patients planned for Phase III (2 pivotal studies of 350 vs

vehicle)

• Winlevi has shown statistical significance in Phase II with only 72 patient

per cohort

• Winlevi has therefore very high potential for showing statistical

superiority vs vehicle

47

statistical significance in IGA improvement (co-primary endpoint)

BID 1.0%

cream

VEHICLE P value

ITT % %

2-Point Improvement 17.1% 6.7% 0,0321

No Change 35.7% 61.3%

PP % %

2-Point Improvement 21.8% 8.5%

No Change 23.6% 59.3%

Dermatology pipeline – Winlevi (Acne)Phase II overview

Winlevi Phase II: statistical significance in total lesion count (co-primary endpoint)

48

CB-03-01 1% cream

BID

VEHICLE P-value

ITT

MEAN -35.7% -13.1% 0.0173

Dermatology pipeline - Winlevi (Acne)Phase II overview

successful also in secondary endpointshowing reduction in Inflammatory Lesion Counts

49

CB-03-01 1% cream BID VEHICLE P-value*

ITT % %

MEAN -37.2% -27.0% 0.0384

* Kruskal Wallis test


50

CB-03-01 1% cream

BID

VEHICLE P-value

ITT

MEAN -32.9% -16.1% 0.0178

successful also in secondary endpointshowing reduction in Non-Inflammatory Lesion Counts


51

Development timeline

• EOP2 achieved on Jan 28th

• Special Protocol Assessment to be discussed with FDA in Q2 2015

• Phase III trials program:

- 2 pivotal trials (US + EU) with > 700 patients/each

FPI in H2 15 LPO in H1 17

- 1 extension trial

- data available H2 17

Dermatology pipeline – Winlevi (Acne)

52

Cassiopea‘s Dermatology Pipeline Alopecia market dynamics & opportunity

20% of all men and 10% of all women between 20-64 lose part of their hair

~ 17% of persons affected use at least one substance• <1% of affected men and women have done hair transplants• <1% of affected men and 5% of affected women use hairpieces

US Market estimated at $ 1 b and EU market at EUR 1.5 b, growing by ~ 2% p.a. • Rogaine and Propecia are only approved products in both markets• Patents for both products have lapsed

Excellent opportunity for new topical drugs with novel treatment forms and very low side effects

53

Dermatology Pipeline – Breezula (Alopecia)

Rinaldi 2010 - International Hair Research Foundation (IHRF)

54



55



56



57


• Only topical anti-androgen for treatment of Androgenetic Alopecia(Propecia® is a tablet)

• Kinetic proof of scalp penetration obtained

• Same mechanism and safety as for acne

58


• POC Phase II ongoing in USA: 90 patients, double blind, 3 parallel arms, placebo and Minoxidil controlled, 26 weeks of treatment, endpoints on scalp darkness and patientsatisfaction.

• The Modified Norwood-Hamilton Scale is used to assess the eligibility of subjects at the Screening Visit. Subject has to have mild to moderate AGA in temple and vertex region rating Modified Hamilton-Norwood Scale III vertex to V (IIIv, IV, V) with ongoing hair loss to be eligible for this study

• Recruitment is in progress and treatment will be completed by end of 2015


59

Dermatology Pipeline – CB-06-02 (HPV) marketdynamics & opportunity

>20 m persons are infected with HPV in the US, around 1% ofsexually active persons in US have visible external genital warts(AGW)

HPV can lead to cancer and should be eradicated

In western countries many young children are vaccinated against the Papillomavirus

• the vaccine is ineffective on persons that already have the virus

• Current market

• around 360’000 persons develop AGW each year in US

• there are ~ 600’000 TRX each year

• main products prescribed are Imiquimod based

60

Dermatology Pipeline – CB-06-02 (HPV)

• Anogenital warts (AGWs) is a common, highly infectious disease caused by the human papillomavirus (HPV)

• Tellurium based compound for treatment of HPV and genital warts

• HPV vaccination is currently in regression because of fertility concerns

61


American family Physician December 15, 2004, 70 (12)

62


• POC Phase II ongoing in Israel on 30 + 30 patients, double blind, parallel arms, 12 weeks of treatment + 3 months of follow up, endpoints on remission and recurrence rates

• Trial Completion foreseen by H1 2016


63

Dermatology Pipeline – CB-06-01 (Acne)

• Topical antibiotic for the treatment of Acne

• Ideal complement to CB-03-01

• NCE with very potent and selective properties

• Effective with bacterial strains resistant to other antibiotics

64

Dermatology Pipeline – CB-06-01 (Acne)Antibacterial spectrum

65

Dermatology Pipeline – CB-06-01 (Acne)Activity against antibiotic-resistant P. acnes

66

Cosmo’s strategic aims for a Cassiopea IPO

• Pursue of equity-for-product strategy with in-house transaction

• Ability to recruit specific derma talents with dedicated Company

• Ability to remunerate specific performance with a dedicated ESOP

• Ability to purchase companies & business with Cassiopea shares

• Set-up of dedicated US commercial infrastructure when appropriate to retain maximum value in the most important derma market

Confidential

67

Expected main features in Cassiopea’s IPO

• Listing SIX

• Timing Targeted in 2015

• Structure Cosmo will fund the company prior to listingall secondary

target retaining less than 50%

• Investors expected support from core Cosmo investors

68

Cosmo Financial Outlook for 2015

• Historical revenues (CDM, Lialda, Uceris/Cortiment) of € 80

million expected

• Opportunity for profits stemming out of Cassiopea’s IPO

• Potential for further products exploitation upon SIC 8000’s

approval and final data for MB and Rifamycin

69

EUR/Million E 2015 E 2016

Traditional contract manufacturing and other revenue 12 12

MMX® products manufacturing 34 38

MMX® products royalties 24 (2) 29 (3)

MMX® licence fees, up-front fees and milestones - 1

Revenues from products under development 80 (4) 163 (4)

Total Revenues 150 243

Operating expenses (5) (54) (5) (67) (5)

EBITDA 96 176

Depreciation and amortization (9) (3)

Operating result 87 173

Sale of "equity for product" stake (6)

Net financial income 3 6

Profit before taxes 90 179

Potentially replaceable with “equity for product” transactions

(2) includes EUR 23,4 M roy on Uceris/Cortiment

(3) includes EUR 28,4 M roy on Uceris/Cortiment

(4) assumes MB and SIC are licensed in 2015 and Rifamycin is licensed in US in 2016

(5) includes SOP and profit bonus

(6) gain on sale of SNTS shares

2015 – 2016 Guidance

70

Key events 2015

• Filing of SIC 8000 with FDA

• Planned IPO of Cassiopea

• Half year financials on July 30

• Results phase III Methylene Blue MMX in H2

• Results phase III Rifamycin SV

71

Cosmo Pharmaceuticals

Information Contacts

• Number of shares: 14,418,983

• Listing: SIX Swiss exchange, Main board

• ISIN: LU1202320294

• Alessandro Della Cha , [email protected]

• Chris Tanner, [email protected]

• Giuseppe Cipriano, [email protected]

• Luigi Moro, [email protected]

report on 2014/media/files/c/cosmo...2 – eu trial (non inferiority vs. cypro) ongoing trial begun...

Documents