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Page 1: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

Financial Report on 2012

Zurich

March 28, 2013

1

Page 2: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

2

Safe Harbour Statement

This 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 Budesonide MMX®, Rifamycin SV

MMX®, Methylene Blue 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 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.

Page 3: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Agenda

• Introduction and 2012 highlights Mauro Ajani, CEO

• 2012 Financial review Chris Tanner, CFO

• Evolving Strategy & Products in Market Mauro Ajani, CEO

• Pipeline update Luigi Moro, CSO

• 2013 Outlook Mauro Ajani, CEO

• Questions & Answers All

Page 4: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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• Very strong growth in Revenues , Operating Profits and Comprehensive

Income delivered a record year for Cosmo on all counts

• Good market performance of Lialda® in USA. Fastest growing UC tablet, 22.5% share in 5- ASA market

• Uceris® approved in January 2013 for marketing in the USA, Cortiment® approved in the Netherlands

• Rifamycin SV MMX® phase III trials in USA attained clinical end points; EU trial ongoing but delays incurred

• CB-03-01 licensed worldwide to Medicis/Valeant; phase II acne in USA ongoing

• CB-17-01 phase II trials for colon cancer diagnosis in surveillance and for patients with longstanding UC completed

• Value of investment in Santarus increased from € 17.8 to € 65.6 million

• Purchase of CCRE for € 13.1 million paid in cash an treasury shares

2012 Highlights

Page 5: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Key Financial Highlights for 2012

• Revenue increased by 77.7% to € 59.5 million

• Revenue from own products increased to 81.1% from 64.4%

• Costs “only” increased by 34.5% to € 33.1 million

• EBITDA increased by 160.6% to € 29.0 million

• Net profit increased by 154.1% to € 19.3 million

• Total comprehensive income increased by nearly 8 times to € 64.0 million

• Cash and financial assets available for sale increased by 192.4% to € 93.4 million

Page 6: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Income Statement and Statement of Comprehensive Income

EUR/1,000 31.12.2012 31.12.2011

Revenues 59,537 33,509

Other Income 70 756

Cost of sales (16,259) (14,468)

Research and development costs (10,916) (5,173)

Selling, general and administrative costs (5,977) (5,629)

Net Operating expenses (33,082) (24,577)

Operating Result 26,455 8,932

Financial income 1,012 1,032

Financial expenses (579) (847)

Profit Before Taxes 26,888 9,117

Income tax expenses (7,564) (1,493)

Profit For The Year 19,324 7,624

EUR/1,000 31.12.2012 31.12.2011

Profit (loss) for the year (A) 19,324 7,624

Gains/(Losses) on fair value of available for sale financial assets 44,726 744

Gains/(Losses) on cash flow hedge (-) (78)

Income tax relating to components of other comprehensive income (10) 18

Total other comprehensive income, net of tax (B) 44,716 684

Total comprehensive income (A)+(B) 64,040 8308

Page 7: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Discussion of Income Statement and Statement of Comprehensive Income

• Overall revenue increased by 77.7% to € 59.5 million

• Recurring revenues increased by 14.9% to € 37.6 million

• Royalties increased by 16.2% to € 11.7 million

• Manufacturing of MMX based products increased by 36.0% to € 14.7 million

• Other contract drug manufacturing decreased by 3.1% to € 10.6 million

• One time license fees and milestones increased very strongly to € 21.9 million

• Operating costs increased by 34.5% to € 33.1 million

• Cost of sales increased by 12.2% to € 16.3 m

• SG&A increased by 5.0% to € 6.0 m

• R&D expenditures increased by 111.0% to € 10.9 million: capitalized R&D costs decreased by 75.3% to € 0.5 m

• Net profit increased by 154% to € 19.3 million

• Increase in value financial assets (primarily SNTS shares) by € 47.3 million caused comprehensive income to jump from € 8.3 million to € 64.0 million

Page 8: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Consolidated Statement of Financial Position

EUR/1,000 31.12.2012 31.12.2011

Financial assets available for sale 66,070 18,304

Other non current assets 45,795 31,137

Cash and cash equivalents 27,302 13,264

Other current assets 12,678 14,973

Total assets 151,845 78,038

Medium-to long-term interest-bearing loans and borrowings

11,040 1,284

Other non-current liabilities 3,825 2,993

Short-term interest-bearing loans and borrowings

1,797 892

Other current liabilities 10,582 9,417

Equity attributable to owners of the company 124,391 63,208

Non controlling interest 210 244

Total equity and liabilities 151,845 78,038

Page 9: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Discussion of Statement of Financial Position

• Net working capital increased by 28.2% to € 6.0 m

• Goodwill & intangible assets up 0.8% to € 22.3 m due to capitalization of development cost of Budesonide MMX®

• Increase of medium term borrowings to € 11.0 million due to acquisition of CCRE and assumption of the loans

• Tangible Net Worth increased by 147.5% to € 102.3 million

• 81.9% of Total Assets financed by Equity

Page 10: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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2012 Cash flow

Cash at the end of the period 27,302

Net cash flow due to CCRE acquisition (6,399)

Transaction with treasury shares 3,203

Additional investment in Cosmo R&D interests (28)

Loan repayment (net of increase) (167)

Investment in fixed assets (net) (1,949)

Investment in intangibles assets (943)

Investment in financial assets available for sales (3,040)

Change in working capital (3,538)

Accrual/payment of employee benefits, other provision and taxes (52)

Income taxes paid (2,902)

Other non cash items 63

Depreciation and amortization 2,542

Profit before taxes 26,888

Cash at the beginning of the period 13,624

(9,000) (6,000) (3,000) 0 3,000 6,000 9,000 12,000 15,000 18,000 21,000 24,000 27,000 30,000

Page 11: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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The Santarus relationship

• Decision not to build up own sales force outside of Italy in 2007

• Building an own sales force with no existing products is expensive

• Seek a small, dependable partner with strong distribution capacity in the USA

• Small: product success is key to them

• Dependable: will put and maintain full efforts

• Competent: has shown to be able to distribute gastro products

• 2008 Selection of Santarus and decision to take all payments in shares

• 2008: 6 m SNTS shares at $ 2.00 plus $2.5 million

• 2010: 972’132 shares instead of $ 3 million

• 2012: 906’412 shares instead of $ 4 million

• The relationship has developed superbly

• Uceris was approved

• Instead of $ 19 million, we now have 7’878’544 shares worth $ 86.5 million per 31.12.12 and $ 136.5 million per 25.3.13

Page 12: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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The Patent Strategy

• Cosmo strategy is to use its increasing knowledge of how substances and compositions of substances work in the colon to create effective patent barriers, involving as much as possible:

• Product patents

• Focus on new entities

• Focus on new compositions

• Focus on new combinations

• Methods or use patents

• Process patents

Page 13: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

Product

MMX®

MESALAZINE MMX®

BUDESONIDE MMX®

RIFAMYCIN SV MMX®

METHYLENE BLUE MMX®

LMWH MMX®

ZACOL- ZACOFALK

CB-03-01

Italy Eastern Europe

EP 1198226 / US 6,773,720

EP 1183014 / US 7,431,943

EP 1287822

US 7,431,943

US 8,293,273

RE 43,799 E

EP 176339 / US 8,263,120

EP 1455761

EP 1992338

EP 1421099 / US 8143240

granted

pending

2020 2018 2022 2024 2026 2028 2030 2032

Page 14: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Product Update

Page 15: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Lialda®

• Indication

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

• Net Sales

• 2012: $ 400 m (+7.5%)

• 2013: $ 450 m (+ 12.5%) analyst projections

• Cosmo Income

• 2012: € 20.8 m (+26.0%) (€ 11.6 m royalties, € 14.6 m manufacturing)

Page 16: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Uceris™*

• FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate ulcerative colitis

• Commercial launch commenced mid-February, 2013

• Ulcerative colitis, an inflammatory bowel disease (IBD), affects

approximately 700,000 patients in U.S.

• Limited therapeutic options mainly involving salycilates, for mild to moderate ulcerative colitis

Locally acting steroid with MMX® colonic delivery Estimated sales potential of ~$300 million

*Please see www.uceris.com for full prescribing and safety information

Page 17: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Established Therapies for Mild to Moderate Ulcerative Colitis

Step-up according to severity at presentation or failure at prior step

5-ASA

Systemic Corticosteroids

Anti-TNFα

Disease severity at presentation

5-ASA / Thiopurine

5-ASA

Anti-TNFα

Induction Maintenance

Cyclosporine Thiopurine

Severe

Moderate

Mild

Kornbluth and Sacher, Am J Gastroenterol 2010; 105: 501-523

Uceris™

Page 18: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Physician Reactions to Uceris™

• Very positive reactions to Uceris messages

• Uceris story is logical

• Putting together two familiar ideas—budesonide and MMX

• Clear need for this product – “I’ve been waiting for someone to formulate budesonide for UC”

• Key drivers of usage: efficacy, budesonide, MMX technology and safety profile

Page 19: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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UCERIS™ iPAD Sales Aid

19

Page 20: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Uceris™ Advertising

Page 21: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Internet Based Patient Programs

Page 22: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Outreach to Patients on UCERIS.com

Page 23: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

23

Pharmacy

Key Uceris™ Customers

Prescribing GEs

KOL

• 300-400 top National, Regional and Local Key Opinion Leaders

• Primary focus of MSL team

Payers

• Government: Medicaid, Medicare, Department of Defense, Veterans Affairs

• Commercial: Insurance Companies

Patients

• ~700K UC patients

• Wholesalers and ~55,000 retail pharmacies

Patients

Payers

KOL

Prescribing GEs

• ~7,500 high potential Gastroenterologists

• Primary focus of Sales Force Patients

Payers Payers

KOL

Prescribing GEs

Page 24: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Selected IBD Products – U.S.

TRx and IMS Sales Trends – January 2013

* Generic version of Entocort EC launched in June 2011.

$79M

27%

$152M

19%

$303M

6%

$414M

-11%

$451M

12%

$773M

-1%

$2,173M

2%

Apriso

Canasa

Pentasa

Entocort EC/Gen*

Lialda

Asacol/HD

Total

LTM Sales, Y/Y Growth

0.2M

0%

0.3M

22%

0.4M

9%

0.5M

-4%

0.7M

6%

1.6M

-3%

3.7M

2%

Canasa

Apriso

Entocort EC/Gen*

Pentasa

Lialda

Asacol/HD

Total

LTM TRx, Y/Y Growth

Page 25: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Uceris™: the Cosmo business case

• Milestone at First sale: $ 7 m

• Royalty: 12% up to annual sales of $ 120 m; 14% above

• Manufacturing: 10% of net sales; all manufacturing at Cosmo

• Sales milestones: $ 5 m when sales reach $ 75 m p.a. $ 17.5 m at sales of $ 150 m p.a.

Page 26: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Budesonide MMX® outside U.S.A.

Cortiment obtained Marketing Authorization in the Netherlands

in January 2013 In alliance with FERRING:

● MRP planned to obtain the MA in the other EU countries by 1H 14 ● Intention to submit a MA in North and South America, Middle East and Far East within the year end.

Page 27: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Pipeline Update

Page 28: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

Product and Indication Drug type

Phase I Phase II Phase III MA Launch Partner

Rifamycin SV MMX®

Travellers’ Diarrhoea

Antibiotic

Dr. Falk – Europe & Australia

(excluding Italy)

Santarus - USA

CB-17-01

- Chromendoscopy for colorectal cancer

prevention in surveillance patients

- Chromoendoscopy for colorectal

cancer prevention in UC patients

Diagnostic

CB-03-01 (NCE)

Acne

Steroid ester,

androgen antagonist

Licensed out world wide

Medicis/Valeant

CB-03-01 (NCE)

Alopecia

Steroid ester,

androgen antagonist

Licensed out world wide

Medicis/ Valeant

LMW Heparin MMX®

- Induction of remission in UC

- Maintenance of remission in UC

Biologic

CB-01-16

Opioid Induced Constipation

Opioids Antagonist

EU

H1/14

H2 13

H1/14

POC H1/15

EU 1/14

USA

2012

2012

2012

H1/14 2012

Drug development Pipeline

2012

Page 29: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Rifamycin SV MMX®:

• Pivotal Trials Status:

• USA :

• Phase III clinical end point (superiority to placebo in travellers diarrhoea) in US trial attained

• Designated as New Chemical Entity by FDA in USA

• EU:

• Patient recruiting for Phase III infectious colitis trials in EU ongoing

• Phase III delayed because of change in regulatory process in India. EU trial is for non inferiority to Cipro. Delay could go into H1 2014.

• Costs

• Borne by licensees

• Cosmo may share some regulatory costs for relocating trial to Latin America

Page 30: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

Colon Cancer Economics

• 7 MMs have 760 m population; ~ 35% over fifty years old

• > 500’000 new colon cancer diagnoses every year in 7 MMs

• 60% of colon cancers are detected in a late stage

• > 170’000 deaths of colon cancer each year in 7 MMs

• Average cost to treat a colon cancer Medicare patient: $ 140’000

• Average cost to treat a late stage patient: $ 310’000

• Cost of a colonoscopy: ~$ 700 - 1000

• Average time of a colonoscopy: 10-12 minutes

• Gross Average polyp detection rate: 44-49% (US data)

• Gross Average adenoma detection rate: 27-32% (US data)

• Cost of a single use spray catheter: $ 80

30

Page 31: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

Methylene Blue MMX clinical development • CB-17-01/03

• Dose finding trial optimal dose administration schedule

• 112 subjects completed

• CB-17-01/04 trial on patients with IBD for longer than 8 years: data to allow sample size determination of dysplastic areas in Ph III

• IBD trial

• 52 patients completed

• CB-17-01/05

• Cancer screening trial data providing for sample size determination of adenomas areas in Phase III

• 96 subjects treated

31

Number and proportion of subjects with detected polyps, adenomas and serrated lesions in the CB-17-01/05 trial population

Colonic region

Methylene blue MMX® tablets

Subjects with at least

one polyp

n (%)

Subjects with at least one

adenoma

n (%)

Subjects with at least one

serrated lesion

n (%)

All regions 61 (63.5) 45 (46.9) 26 (27.1)

Right colon 32 (33.3) 24 (25.0) 9 (9.4)

Page 32: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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CB-03-01 in 2012 and onwards

• Signed advisory & support agreement with Intrepid Therapeutics

• IND filed and approved

• Signed licensing agreement with Medicis in April

• $ 25 m received

• 360 patients to be enrolled, 4 cohort phase II increasing dose study in acne

• First cohort completed, second cohort going to be completed in April, no major adverse events to date

• Valeant acquired Medicis and reaffirmed major strategic interest

• Next milestone

• At EOP II acne $ 20 m (expected H1 2014)

Page 33: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Financial Outlook for 2013: looking to another record year

• Revenues projected at > € 60 million

• Flat COGS

• R&D expenditures increase by 55% to ~ € 17 m

• SG&A unchanged

• Operating income increase corresponding to revenue increase

Page 34: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Key events 2013

• May: First quarter results from Uceris sales in USA

• Launch phase III for Methylene Blue MMX in the USA and EU in Q2/Q3

• Half yearly financials on August 2

• Launch of Cortiment® in the Netherlands

• Approval of Cortiment® in other EU states

• Possible results of phase III Rifamycin SV trials for infectious diarrhoea in EU at end H2

Page 35: Financial Report on 2012 - Cosmo Pharma/media/Files/C/Cosmo-Pharmaceut… · • FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate

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Cosmo Pharmaceuticals

Information Contacts

• Number of shares: 14,995,743

• Listing: SIX Swiss exchange, Main board

• ISIN: IT0004167463

• Mauro Ajani, CEO [email protected]

• Chris Tanner, CFO [email protected] ph: +39-02-9333’7453

• Giuseppe Cipriano, COO [email protected]

• Luigi Moro, CSO [email protected]