Report on first half 2013 - cosmopharma.com · •Questions & Answers All . 4 4 • Approval of...
Transcript of Report on first half 2013 - cosmopharma.com · •Questions & Answers All . 4 4 • Approval of...
Report on first half 2013
Lainate
July 31, 2013
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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.
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Agenda
• Introduction and H1 2013 highlights Mauro Ajani, CEO
• H1 2013 Financial review Chris Tanner, CFO
• Pipeline update Luigi Moro, CSO
• 2013 Outlook Mauro Ajani, CEO
• Questions & Answers All
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• Approval of Uceris® in the USA in January and launch in February
• Approval of Cortiment® in Holland in January
• Agreement of FDA to phase III clinical trial protocol for CB-17-01 Methylene Blue MMX®
• Indian Authorities allow continuation of Rifamycin SV MMX® phase III trials in India
• CB-03-01 clinical trails progressing as planned
• Sale of 4’885’500 SNTS shares generating a net profit of € 58.2 million
• Lialda® market share continued improving
• COPN will be included in the SXI Life Sciences Index as of September 23
H1 2013 Highlights
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Income Statement and Statement of Comprehensive Income EUR/1,000 30.06.2013 30.06.2012
Revenues 26,562 40,732
Other Income 15 35
Cost of sales (9,519) (7,759)
Research and development costs (5,791) (4,437)
Selling, general and administrative costs (4,575) (3,399)
Net Operating expenses (19,870) (15,560)
Operating Result 6,692 25,172
Financial income 58,542 984
Financial expenses (365) (263)
Profit Before Taxes 64,869 25,893
Income tax expenses (1,530) (7,188)
Profit For The Period 63,339 18,705
EUR/1,000 30.06.2013 30.06.2012
Profit (loss) for the period (A) 63,339 18,705
Gains/(Losses) on fair value of available for sale financial assets (8,772) 23,500
Gains/(Losses) on cash flow hedge reclassified to profit or loss 14 (12)
Income tax relating to components of other comprehensive income 1 (2)
Total other comprehensive income, net of tax (B) (8,758) 23,486
Total comprehensive income (A)+(B) 54,581 42,190
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Discussion of income statement H2 2013
• Overall operating revenues declined by 34.8% to € 26.6 million
• Royalties increased by 30.9% to € 7.3 million
• Lialda royalties increased 6.0% to € 5.8 million
• First time Uceris royalties reached € 1.4 million
• MMX Manufacturing increased by 9.8% to € 8.4 million
• Lialda manufacturing revenue declined by 6.8% to € 7.2 million
• First time Uceris manufacturing revenue reached € 1.3 million
• Contract drug manufacturing increased by 2.3% to € 5.4 million
• One time license fees and milestones decreased by 76.1% to € 5.2 million
• Last year there were two milestone payments (one for Uceris of $ 4 m and one for CB-03-01 of $ 25 m) this year there was only one, $ 7 million for Uceris
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Discussion of income statement H2 2013
• Operating costs increased by 27.7% to € 19.9 million
• COGS increased by 22.7% to € 9.5 million
• SG&A increased by 34.6% to € 4.6 million
• R&D expenditures increased by 30.5% to € 5.8 million
• Higher raw material and consumables cost due to increased activity
• No change in personnel but payment of one time Uceris success bonus to all employees of € 1.7 million
• Payment of facility fee to FDA to qualify as manufacturer of generics
• Increase of amortization and depreciation because of higher property, plant and equipment due to Cristoforo Colombo Real Estate purchase and because first time write off capitalized Budesonide R&D
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Discussion of income statement H2 2013
• EBITDA declined from € 26.3 million to € 9.4 million
• Financial gain of € 58.2 million on sale of 4’885’500 SNTS shares
• Gross proceeds reached $ 89.2 million or € 69.3 million, the net realized gain amounted to € 58.2 million
• Net profit increased from € 18.7 million to € 63.4 million
• Comprehensive Income increased by 29.4% to € 54.6 million
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Consolidated Statement of Financial Position
EUR/1,000 30.06.2013 31.12.2012
Financial assets available for sale 51,231 66,070
Other non current assets 44,754 45,795
Cash and cash equivalents 95,149 27,302
Other current assets 16,204 12,678
Total assets 207,338 151,845
Medium-to long-term interest-bearing loans and borrowings
10,924 11,040
Other non-current liabilities 3,703 3,825
Short-term interest-bearing loans and borrowings
1,729 1,797
Other current liabilities 8,653 10,582
Equity attributable to owners of the company 182,168 124,391
Non controlling interest 161 210
Total equity and liabilities 207,338 151,845
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Discussion of Statement of Financial Position I
• Cash and Cash equivalents increased by € 67.8 m to € 95.1 m
• Good will and intangible assets decreased by 4.5% to € 21.3 million because amortization of capitalized Budesonide R&D started
• Financial assets available for sale decreased by 22.5% or € 26.5 m to € 51.2 m because the number of SNTS shares declined by 4’887’500 or 38% to 2’991’044 SNTS shares. The value of each share increased from $ 10.98 to $ 21.05 per 28.6
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Discussion of Statement of Financial Position II
• Short term loans declined by 3.8% to € 1.7 million
• Primarily subsidized loans
• Medium term loans and borrowings declined by 1.1% to € 10.9 million
• Came along with Cristoforo Colombo Real estate acquisition
• Equity attributable to owners of the company increased by €57.8 m to €182.2 m
• 14’995’743 shares issued
• 816’227 treasury shares in books, purchased at € 16.56
• 177’622 treasury shares were used to fulfil ESOP obligations
• 87.9% of total Assets financed by Equity
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1H 2013 Cash Flow
Cash at the end of the period 95,149
Transaction with treasury shares 3,173
Additional investment in Cosmo R&D interests (35)
Loan repayment (net of increase) (192)
Disposal of financial assets 66,839
Investment in fixed assets (net) (1,345)
Investment in intangibles assets (444)
Investment in financial assets available for sales (2,594)
Change in working capital (1,644)
Accrual/payment of employee benefits, other provision and taxes 1,052
Income taxes paid (6,329)
Other non cash items 17
Financial gain on sale of financial assets available for sale (Santarus shares) (58,178)
Depreciation and amortization 2,658
Profit before taxes 64,869
Cash at the beginning of the period 27,302
(60,000) (40,000) (20,000) 0 20,000 40,000 60,000 80,000 100,000
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Pipeline Update
Product and Indication Drug type Phase I Phase II Phase III MA Launch Partner
Lialda ®/ Mezavant ®/Mesavancol®
Mild to moderate Ulcerative Colitis
5-ASA Giuliani-Shire
Zacol NMX®
Intestinal Disorders (nutraceutical)
Dietary supplement
Dr. Falk
Uceris/Cortiment
Mild to moderate Ulcerative Colitis
Cortico-steroid
Santarus- USA
Ferring – Worldwide (excluding Japan & USA)
Rifamycin SV MMX®
-Travellers’ Diarrhoea
-Uncomplicated diverticulitis
Antibiotic
Santarus - USA
Dr. Falk – Europe & Australia
(excluding Italy)
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
Italy Eastern Europe
USA
EU
EU
Q3 HOLLAND CORTIMENT
USA
UCERIS
EU
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Lialda®
• Legal
• On May 9, Shire announced it prevailed in the patent infringement case against Actavis. Acatavis is appealing
• Net Sales
• H1 2013: $ 238 m (+29.3%)
• Cosmo Income
• H1 2013: € 13.0 m (-1.6%) (€ 5.8 m royalties, € 7.2 m manufacturing)
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Budesonide MMX; Uceris® & Cortiment®
• Uceris approved in January and launched on February
• Q1 TRX: 2’200; Q1 Revenue: USD 6.6 million
• Q2 TRX: 11’528 Q2 Revenue: to be announced August 6
• Cosmo Revenue:
• Milestone: USD 7 million
• Manufacturing revenue: USD 1.3 million
• Royalties: USD 1.4 million (assumption revenues of USD 15 m for H1)
• Cortiment approved in January for the Netherlands
• Launch expected in Q4 2013
• Marketing authorization transferred to Ferring
• MRP to be filed
• Next approvals to be expected beginning 2014
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Rifamycin SV MMX®
• Regulatory status • Indian Authorities approved continuation of Infectious Diarrhoea phase III clinical
trial by licensee Dr. Falk Pharma
• Number of patients
• 250 patients still need to be recruited for a 3-5 days treatment
• Timing • Trial to start after the monsoon ends in September
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CB-03-01:anti adrogen for topical applications
• Phase II for acne ongoing • Second cohort of 90 patients concluded
• Recruitment of third cohort underway
• Phase I alopecia • Completion of toxicological studies ongoing
• Phase I PK ongoing (treatment completed)
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CB-17-01 Methylene Blue MMX for colon cancer diagnosis
• Phase II clinical trial for patients with long standing UC completed
• SPA filed and Phase III protocol agreed with FDA
• Protocol subsequently submitted and currently under evaluation by EMA
• CROs selected, sites selected, investigator meetings determined
• First treatment in US projected for early Q4
• First treatment for EU projected for later Q4
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Outlook for 2013
• Continued growth in royalties and manufacturing revenues
• Strong growth in Uceris expected
• Launch in Cortiment expected
• Lialda to continue gaining market share
• Start of phase III in Methylene Blue MMX in USA and EU
• Re start of Rifamycin SV MMX phase III in India
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Cosmo Pharmaceuticals
Information Contacts
• Half-Year Report 2013: 31 July 2013
• 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: +39-02-9333’7276
• Giuseppe Cipriano, COO [email protected]
• Luigi Moro, CSO [email protected]