report on first half 2014 - cosmo pharma/media/files/c/cosmo... · 2014-07-29 · •h1 2014...
TRANSCRIPT
Report on first half 2014
Lainate
July 30, 2014
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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 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.
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Agenda
• Introduction and H1 2014 highlights Alessandro Della Cha’, CEO
• H1 2014 Financial review Chris Tanner, CFO
• Pipeline update Luigi Moro, CSO
• 2014 Outlook Alessandro Della Cha’, CEO
• Questions & Answers All
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• Uceris® net revenues are estimated to have exceeded $ 100 m
• Lialda® market share continued improving to 31% of 5 ASA market
• Phase III clinical trial for CB-17-01 Methylene Blue MMX® in North America and EU well underway
• Developed SIC 8000, a sub-mucosal injectable composition for the extraction of polyps in the colon
• Completed CB-03-01 phase II clinical trails in acne and recovered license from Valeant
• Sold remaining 2’991’044 SNTS shares generating a net profit of € 65.1 million
• Paid a first time dividend of € 1 per share and repurchased 4% of shares in a public share buy back
H1 2014 Highlights
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Income Statementand Statement of Comprehensive Income
EUR/1,000 30.06.2014 30.06.2013
Revenues 41,077 26,562
Other Income 22 15
Cost of sales (10,061) (9,519)
Research and development costs (9,202) (5,791)
Selling, general and administrative costs (7,230) (4,575)
Net Operating expenses (26,471) (19,870)
Operating Result 14,606 6,692
Financial income 66,818 58,542
Financial expenses (2,047) (365)
Profit Before Taxes 79,377 64,869
Income tax expenses (2,569) (1,530)
Profit For The Period 76,808 63,339
EUR/1,000 30.06.2014 30.06.2013
Profit (loss) for the period (A) 76,808 63,339
Other comprehensive income that will be not reclassified to P/L (23) 14
Other comprehensive income that will be reclassified to P/L (63,686) (8.772)
Total other comprehensive income, net of tax (B) (63,709) (8,758)
Total comprehensive income (A)+(B) 13,099 54,581
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Discussion of income statement H2 2014
• Overall operating revenues increased by 54.6% to € 41.1 million
• Royalties increased by 104.0% to € 14.8 million
• Lialda royalties increased 1.3% to € 5.9 million
• Uceris royalties increased more than 6 times to € 8.9 million
• MMX Manufacturing increased by 96.9% to € 16.6 million
• Lialda manufacturing revenue increased by 24.4% to € 8.9 million
• Uceris manufacturing revenue increased nearly 7 times to € 9.0million
• Contract drug manufacturing for third parties increased by 9.4% to€ 5.9 million
• Revenues from own products increased from 78.8% to 85.4% of total
• license fees and milestones declined by 30.3% to € 3.7 million
• Last year there was one $ 7 million for Uceris for first sale; this year$ 5 million for first time net sales exceeding $ 75 million
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Discussion of income statement H2 2014
• Operating costs increased by 33.2% to € 26.5 million
• COGS increased by 5.7% to € 10.1 million
• SG&A increased by 58.0% to € 7.2 million
• R&D expenditures increased by 58.9% to € 9.2 million
• Raw material and consumables were well contained at + 5.7%
• Personnel expense increased 20.3% on the back of head count increasing by10.6% and ESOP allocation
• Advertising & marketing costs increased to € 1.5 million because of the Zacoladvertising campaign
• R&D increase driven by costs for Methylene Blue MMX trial and CB-03-01 trial aswell as internal development of SIC 8000
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Discussion of income statement H2 2014
• EBITDA increased by 103.3% to € 19.0 million from € 9.4 million
• Financial gain of € 65.1 million on sale of 2’991’044 SNTS shares
• Gross proceeds reached $ 95.7 million or € 70.4 million, the net realized gainamounted to € 65.1 million
• Net profit increased by 21.3% to € 76.8 million
• Comprehensive Income declined by 76% to € 13.1 million
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Consolidated Statement of Financial Position
EUR/1,000 30.06.2014 31.12.2013
Non current financial assets 83,390 15,513
Other non current assets 35,496 39,160
Cash and cash equivalents 28,713 46,338
Current financial assets 24,761 121,823
Other current assets 26,652 20,170
Total assets 199,012 243,004
Medium-to long-term interest-bearingloans and borrowings
8,795 9,762
Other non-current liabilities 3,313 3,388
Short-term interest-bearing loans andborrowings
2,021 1,986
Other current liabilities 10,481 7,713
Equity attributable to owners of the company 174,390 220,140
Non controlling interest 12 15
Total equity and liabilities 199,012 243,004
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Discussion of Statement of Financial Position I
• € 14.3 million cash were used to pay dividends and € 46.1 million cashwas used to repurchase shares in a 4% public share buy back
• This was financed by a decrease in Cash and Cash equivalents of € 17.6million which decreased by 38% to € 28.7 m and by a reduction ininvestments in financial assets by € 29.2 million or 21.2% to € 108.2million
• Intangible assets decreased by 18.7% to € 13.4 million because ofamortization of capitalized Uceris® & Cortiment® R&D
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Discussion of Statement of Financial Position II
• Short term loans increased slightly by 1.8% to € 2.0 million because of areclassification of non current loans
• Primarily subsidized loans
• Medium term loans and borrowings declined by 1.1% to € 8.8 million
• € 7.3 million are financial lease obligations that came along with the Cristoforo
Colombo Real estate acquisition
• Equity attributable to owners of the company decreased by €45.7 millionto €174.4 m
• 14’995’743 shares issued
• 741’099 treasury shares in books, purchased at CHF 79.64
• 87.6% of total Assets are financed by Equity
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1H 2014 Cash Flow
Cash at the end of the period 28,713Transaction with treasury shares (46,093)
Dividends paid (14,255)
Additional investment in Cosmo R&D interests(5)
Loan repayment (net of increase) (936)
Disposal of financial assets 99,081
Investment in fixed assets (net) (559)
Investment in intangibles assets (93)
Investment in financial assets available for sales (69,192)
Change in working capital (4,532)
Accrual/payment of employee benefits, other provision and taxes (311)
Income taxes paid (1,530)
Other non cash items 2,107
Financial gain on sale of financial assets available for sale (Santarus shares) (65,089)
Depreciation and amortization 4,405
Profit before taxes 79,377
Cash at the beginning of the period 46,338
(80,000) (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 typePreclinic
alPhase I Phase II Phase III MA Launch Partner
Uceris/Cortiment
Mild to moderate Ulcerative Colitis
Cortico-steroid
Salix- USA & upon closing
Japan
Ferring – Rest of World
Rifamycin SV MMX®
-Travellers’ Diarrhoea
-Uncomplicated diverticulitis
Antibiotic
Upon closing licensed to
Salix in USA, Latam & Asia
Dr. Falk –Europe & Australia, (excluding
Italy) Crinos –Italy
CB-17-01
- Chromendoscopy for
colorectal
cancer prevention in surveillance patients
- Chromoendoscopy for colorectal cancer
prevention in UC patients
Diagnostic
Upon closing licensed to
Salix in USA
CB-01-12
Antibody AntiTNFα
Immunosuppressant
CB-17-04
Sub mucosal injectablecomposition
Medical device
CB-03-01 (NCE)
Acne
Steroid ester, androgen antagonist
CB-03-01 (NCE)
Alopecia
Steroid ester, androgen antagonist
•CB-06-02
•Genital Warts•Tellurium
•Licensed in fromBioMas
ItalyEastern Europe
EU
UCERIS
EU
USA
EU
CORTIMENT
PoC
PoC in USA
EU
USA
USA & EU
USA
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Lialda® & Mezavant® & Mesavancol ®
• Lialda® & Mesavancol® Net Sales
• H1 2014: $ 272 m (+14.3%)
• Cosmo Income
• H1 2014: € 14.8 m (+13.8%) (€ 5.9 m royalties, € 8.9 mmanufacturing)
• General royalty cap has been reached. $ 15 million royalties stillachievable by sales of Lialda®, once approved, in Japan
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Uceris® & Cortiment®
• Uceris® estimated net revenues in H1
• USD 100.1 million
• Cosmo Revenue on Uceris®:
• Milestone: € 3.7 million
• Manufacturing revenue: € 7.7 million
• Royalties: € 8.9 million (based on estimated net Uceris® revenues of Salix of USD 100.1 million)
• Business Development
• If transaction with Salix closes, Salix is to license Uceris in Japan and Cosmo gets 50% of milestones and royalties
• Ferring is preparing launches of Cortiment® in 17 primarily EU countries in 2015 and 12 further EU countries in 2016
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Rifamycin SV MMX®
• Development status• Travellers Diarrhoea:
• Trial started in Latin America: Mexico, Guatemala, Ecuador, Peru, all in all anadditional 200 patients need to be recruited to get to the target trial size of 1000
• Diverticulitis:
• Dr. Falk is conducting a phase II trial for the treatment of non complicateddiverticulitis. 61 out of a targeted 450 patients have been recruited
• Timing• TD trial expected to be completed in H1 2015
• Diverticulitis phase II scheduled to be completed in H2 2015
• Business Development:
• If Salix transaction closes then Salix get rights to entire world except for EU(which is licensed to Dr. Falk)
• 50% of milestones and royalties generated by Salix outside of US are due toCosmo
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CB-17-01 Methylene Blue MMX for colon cancer diagnosis
• Development status• All in all 1230 patients to be treated in phase III in 13 sites
• Phase III trial for IBD patients in preparation
• Timing• Target for phase III trial completion is end 2014
• Business Development• If Salix transaction closes then Salix get rights to the USA
• Licensing to the RoW will commence once phase III data is in in H1 2015
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CB-17-04 SIC 8000
• Development status• USA
• Pre submission meeting with FDA took place June 23
• Classified as a type II b medical device
• No need of clinical trials
• EU
• Pre submission meeting took place with ISS acting for EU July 28; no need for clinical trials
• Timing• Targeted for launch in EU and USA in H1 2015
• Business Development• Licensing process will commence in Q4 2014
• Salix has first right of refusal in USA
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CB-03-01:anti adrogen for topical applications
• Development status• Acne
• EOPII meeting with FDA scheduled for September
• Possible start of phase III in Q4 14
• Alopecia
• IND requested for POC with 3 arms, 120 patients against minoxidiland placebo
• Timing• Acne: Phase III to target to be completed H2 2016
• Alopecia: POC targeted to be competed end 2015
• Business Development• Regained product from Valeant
• Valeant has first right of refusal if we decide to re-license
• Spin off initiatives will start in H2 2014
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Outlook for 2014
Operations
• Strong continued growth in Uceris expected
• Cap in Lialda attained. Slight continued growth in manufacturing revenues
• Normal development in general contract drug manufacturing
Clinical development
• Restart of Phase III TD Rifamycin SV MMX in Latin America
• EOPII meeting with FDA for CB-03-01 acne; first patient Q1 2015
• Continuation of POC alopecia trial
• Completion of phase III Methylene Blue MMX in North America and EU
• Continuation of genital warts trial
Business development
• Closing of Salix transaction
• Start licensing process for SIC 8000
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Cosmo Pharmaceuticals
Information Contacts
• Half-Year Report 2014: 30 July 2014
• Number of shares: 14,995,743
• Listing: SIX Swiss exchange, Main board
• ISIN: IT0004167463
• Alessandro Della Cha’, [email protected]
• Chris Tanner, [email protected]: +39-02-9333’7276
• Giuseppe Cipriano, [email protected]
• Luigi Moro, [email protected]