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Corporate Presentation
November 2018
Safe Harbour
2
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 commercialization 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 its products. 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.
Introduction and YTD 2018 Key Events
2018 YTD Financial Highlights
Products and R&D Update
2018 Outlook & Forecast
Questions & Answers
Agenda
3
Key Events YTD 2018
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➢ Methylene Blue MMX: the FDA ODE IV has denied our appeal. Cosmo is now drafting
the subsequent appeal to the Office of New Drugs, which is the office that supervises
the Office of Drug Evaluation IV (and all the others Offices of Drug Evaluation).
Timeline for an answer will be again 30 days from filing (unless there is a request of
additional information or meetings or an advisory committee)
➢ Aemcolo (Rifamycin SV MMX): PDUFA date is set on November 16. Pre-launch
activities ongoing
➢ Cassiopea SpA, of which Cosmo owns 45.09%, communicated a sequence of very
good news: the successful Phase III clinical trial outcome of its drug Winlevi for the
treatment of acne and the successful Phase II clinical trial interim analysis of its drug
Breezula for the treatment of Androgenetic Alopecia
Key Events YTD 2018
5
➢ Aemcolo: Phase II proof of concept study in IBS-D progressing
➢ License and supply agreement entered into with Pharmascience for Eleview,
Methylene Blue MMX, Aemcolo and Qolotag for the territory of Canada
➢ Eleview agreement with FUJIFILM Europe B.V. expanded to South East Asia, Middle
East, Africa, Australia and New Zealand, Cosmo to receive 45% of gross revenues
➢ License and supply agreement entered into with EA Pharma for Methylene Blue MMX
and Eleview for the territories of Japan and South Korea
Financial Highlights YTD 30.09.2018
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➢ Revenue €50.1m versus €48.3m in prior year➢ Uceris and Lialda income slightly decreased, offset by the increased Eleview sales
and milestones/licenses fee
➢ Operating costs of €62.6m, up €7.4m versus prior year
➢ Cash, Bonds and Investment in Funds were €234m at 30 September 2018
compared to €247.2m at 31 December 2017
➢ Aries operating expenses are €27.8m YTD versus €22.3m YTD in FY17 as Aries
prepares for Aemcolo launch
Financial Highlights YTD 30.09.2018
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➢ Cortiment net sales are up 11% versus last year and Cosmo income
is up 13% (€2.7m)
➢ Eleview sales on track (expected 2018 gross revenue $11m)
➢ Uceris estimated net sales US$80.8m down 17.6% versus prior year. Manufacturing and
Royalty Income down 19.6% to €14.7m ➢ In July 2018, the FDA approved the Teva generic of Uceris. Notwithstanding the ongoing patent
infringement trial, Teva launched the generic in July. Subsequently Valeant launched its Authorised
Generic.
➢ Lialda/Mezavant/Mesavancol revenue decreased by 18.3%, mainly as a result of lower Lialda
orders due to the generic launch in the US partially offset by an increase in orders for Japan,
where income increased by €3.3m from €0.5m to €3.8m (including estimated royalties)
➢ Up-front fees & milestone income of €5.2m from Pharmascience, EA Pharma and Crinos SpA
➢ Generic & Other income reduced by €0.5m to €5.9m
Statement of Financial Position 30.09.2018
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Cash, Bonds and
Investments in
Funds
€234m
Equity
€457.3m
Products and R&D Update
9
10
Methylene Blue MMX: Formal Dispute Resolution
➢ The first appeal on the CRL after the Type A meeting was filed at the FDA Office of Drug Evaluation (ODE) IV. The appeal was denied and a second trial was requested
➢ The next appeal to seek further review will be at the Office of New Drugs, Center for Drug Evaluation and Research, which is the office that supervises, among others, the ODE IV
➢ Cosmo is currently drafting the appeal. The answer to which can be expected within 30 days from filing. Such deadline may be extended if the office requests further information or meetings or an advisory committee
➢ If the next appeal is denied at the Office of New Drugs level, the final level of appeal is the Center Director and the timeline for the decision would remain the same
➢ Timing: PDUFA for Traveller’s Diarrhea (TD) November 16, 2018; Launch
planned for February 2019 with a wholesale price of $ 144 per box (12 tablets)
➢ Aries Team: Very experience US commercial team with extensive experience
launching GI products
➢ Market
• Enthusiastic for first new GI-disease specific antibiotic in 15 years
• Clinical value in delayed colonic release and minimal drug absorption
• Desire for new antibiotics in response to growing resistance to current
antibiotics in US
11
Aemcolo – Commercialization
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Aemcolo – Commercialization
➢Unique Product Attributes • Received FDA Qualified Infectious Disease Product (QIDP) designation for serious and life-threating infections
• Colon-targeting release profile (MMX®) - the site of significant disease-causing bacteria
• Only product to compare to ciprofloxacin
• Clinical equivalence (TD) with potential safety and tolerability advantages
• Decreased potential for development of multi-drug resistant bacteria
• Anti-inflammatory and c. difficile effects (invitro/Pre-clinical)
➢Launch Strategy• Capitalize on sole promotion in TD market
• Targeted resources and promotion to gastroenterologists
• Create broad payer coverage, growing overtime, through contracting initiatives
➢Long-term Strategy• Develop expanded clinical data and evidence across range of conditions
• Initiate series of studies in 2019
13
Aemcolo – US Market Opportunity
➢ Sales of Xifaxan US$1 billion
➢ Estimated Market Opportunity US$1 billion
➢ 20-25% market share
➢ Estimated peak sales US$200m - $250m
➢ Estimated time line to peak sales 7 - 8 years
➢ Will be promoted by a sales force of 48 reps at onset
➢ Aemcolo sales forecast 2019: US$15m gross
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Aemcolo – US Market Opportunity
➢ Physicians perceive advantages in the product over competitors
➢ Lower likelihood of developing resistance, efficacy in C-diff
➢ Based on a survey of 200+ physicians, they would prescribe Aemcolo in at
least 1/3rd of the cases where they prescribe branded competitors assuming
similar price
➢ Based on a survey of 15 payors covering over 100m US lives, payors believe
that an acceptable price for Aemcolo is close to that of Xifaxan, the only
branded treatment for traveler’s diarrhea
15
Aemcolo – US Market Opportunity
➢ Physician Perceptions of Aemcolo:
➢ Sampled physicians consider Aemcolo to perform slightly better across all
product attributes
➢ Performance scores of 5.2-5.5/7 for all attributes
➢ Sampled physicians believe that Aemcolo perform moderately better than the
SoC (5.2/7)
➢ Clinical cure rate as well as general safety/tolerability were noted as the primary
positive attributes for Aemcolo – this mirrors favorably to their stated prescribing
decision-making
➢ Non-systemic absorption is also stated as a key product attribute
➢ There is little difference in product perception between gastroenterologists and
internal medicine physicians
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➢ 16m 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$92.50 per vial
➢ Market Opportunity approx. US$350m
➢ Estimated peak sales US$65m - $75m (20% of the market)
➢ Time line to peak sales 7 - 8 years
Eleview – US Market Opportunity
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➢ Launched at DDW in May 2017
➢ Units October 2018: 2,684, Units May 2017 to October 2018: 24,492
➢ Eleview forecast 2018: US$ 11m (gross sales), 2019: US$ 15m
Eleview – US Market Opportunity
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Eleview – US Monthly Units
-
200
400
600
800
1,000
1,200
1,400
1,600
1,800
2,000
2,200
2,400
2,600
2,800
May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17 Dec-17 Jan-18 Feb-18 Mar-18 Apr-18 May-18 Jun-18 Jul-18 Aug-18 Sep-18 Oct-18
2574
314
572
692
1,021
1,2871,338
1,5861,650
1,958
1,731
1,955
1,776
1,9221,977
1,930
2,684
Eleview – Cumulative Net Sales US$ May ‘17 to October ‘18
19
$0
$1,000,000
$2,000,000
$3,000,000
$4,000,000
$5,000,000
$6,000,000
$7,000,000
$8,000,000
May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17 Dec-17 Jan-18 Feb-18 Mar-18 Apr-18 May-18 Jun-18 Jul-18 Aug-18 Sep-18 Oct-18
$9,998 $35,543 $155,681
$377,298
$645,585
$979,543
$1,383,851
$1,770,310
$2,539,578
$3,009,801
$3,595,297
$3,952,650
$4,600,813
$5,088,785
$5,634,087
$6,162,597
$6,794,269
$7,703,177
➢ Successfully completed phase III trials in colonoscopy, bronchoscopy and II/IV ASA patients. These trials conclude the set of trials required for procedural sedation registration
➢ NDA filing expected by end Q1 2019
➢ Five years regulatory exclusivity as NCE
➢ Six patents granted, last expiring 2033
Remimazolam – Regulatory Approval Update
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➢ Sedative selection is highly correlated with monitored anesthesia care (MAC) utilization
➢ In general, physicians are moderately satisfied with available sedative options
➢ Onset of action, breakthrough discomfort, and delayed recovery were the most cited areas of concern for midazolam
➢ Hypotension was mentioned as a concern for Propofol
➢ Reaction to the product concept was favorable with an average enthusiasm score of 7.5 (scale of 1-10)
➢ Potential for faster patient throughput, shorter half-life, safety, and speed of onset were cited as the most valuable attributes of the product
21
Remimazolam – Physician Feedback
➢ Physicians indicated that Remimazolam will most likely be considered as a replacement for midazolam in routine procedures dependent on price and value
➢ Based on the primary research feedback, no significant changes to the forecast for procedural sedation
➢ Midazolam share capture of 30-45% and eventual Propofol share capture depending on overall perception of the benefits of Remimazolam once on the market
➢ Pricing assumed at US$30/procedure (average 24mg used, or US$1.25/mg), pending updates from the reimbursement assessment work
22
Remimazolam – Commercial Opportunity
➢ 24.5m annual US colonoscopies, upper GI endoscopies and bronchoscopies
➢ 90% of US colonoscopies, upper GI endoscopies and bronchoscopies that used Moderate Sedation
➢ Estimated market opportunity in procedural sedation US$600m
➢ Estimated peak sales US$150m – $200m
➢ Estimated timeline to peak sales: 5 - 7 years
23
Remimazolam – Commercial Opportunity
➢ 82-person organization in place as at October 2018 (to be increased to 107 in 2019)
➢ 59 marketing and sales
➢ 10 MSL and Scientific Affairs
➢ 13 Management and Administration
➢ Eleview launched at DDW in May 2017
➢ Aemcolo pre-launch activity underway
➢ Expected revenues 2019: US$ 30m (gross sales)
➢ Eleview US$ 15m
➢ Aemcolo US$ 15m
➢ Expected Opex 2019: US$ 50m
US Organisation: Aries
24
US Market Opportunity
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Estimated peak sales US: 7 - 8 years after launch
Eleview
US$65m - $75m
Methylene Blue
MMX
US$600m -
$700m
Aemcolo
US$200m -
$250m
Remimazolamprocedural sedation:
US$150m -
$200m
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Cosmo: A Manager of Multiple Assets
100%Uceris/Cortimentand Lialda/Mezavant/MesavancolFranchise
45,09%
License agreements for selected pipeline products in Europe, Japan, Middle East, South East Asia, China, Canada
successful phase III
for Winlevi®,
successful phase II
for Breezula®,
CB-06-01
CB-06-02
US rights to Eleview, Aemcolo, Remimazolam, Methylene Blue MMX
Investments in: Paion, VolitionRX, AIMM and other companies
Undisclosed
Pipeline
Contract
manufacturing
Key Priorities and Upcoming Milestones 2018-2019
Appeal MB MMX decision within FDA
Progress Aemcolo IBS-D Phase II trial
File Remimazolam NDA
Partner pipeline in RoW
Aemcolo PDUFA on November 16 2018
27
2018 Cosmo Overall Guidance
28
€M FY 2018
Traditional contract manufacturing and other revenue 11
Products manufacturing 27
Royalties 15
Licence fees, up-front fees and milestones 5
Aries U.S. sales 10
Total Revenues 68
Total Operating Expenses* (85)*Of which investment in Aries 36
Total EBITDA** (17)**Cassiopea share of result not included
Cosmo Pharmaceuticals NV
Riverside IISir John Rogerson’s QuayDublin 2, Ireland
Mr. Alessandro Della Chà, [email protected]
Mr. John Manieri, IR
[email protected]+353 1 817 03 70