Cosmo Pharmaceuticals Nv · SIX:COPN
Cosmo Pharmaceuticals Nv — FY2016 Earnings Presentation
70 slides from Cosmo Pharmaceuticals Nv's earnings presentation, Mar 24, 2017
Slide 1: Report on 2016
Report on 2016 Zurich March 24, 2017
Slide 2: Safe Harbour
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
Slide 3: Agenda
Agenda 3 • Introduction and 2016 highlights Alessandro Della Chà • 2016 Financial review Chris Tanner • Products on the market Alessandro Della Chà • Pipeline update Alessandro Della Chà • 2017 Outlook Alessandro Della Chà • Questions & Answers All
Slide 4: 2016 Strategic Highlights
2016 Strategic Highlights 4 • LuMeBlue® and Zemcolo phase III clinical trials delivered excellent results • In-licensing of Remimazolam for USA from PAION enlarges a unique offering for endoscopists in a mass market • This product range allows setting up an own marketing and distribution organisatio
Slide 5: 2016 Financial Highlights
2016 Financial Highlights 5 • Operating revenues increased by 11.6% to € 67.7 million • Operating costs down by 34.8% to € 43.0 million because of decrease in management bonus • Profit after tax of € 19.3 million (2015 results were primarily driven by the € 257.8 million gain on the sale of Cassiope
Slide 6: Income Statement
Income Statement 6 EUR/1,000 31.12.2016 31.12.2015 Revenues 67,664 60,607 Other Income 730 22 Cost of sales (19,851) (20,107) Research and development costs (8,257) (23,083) Selling, general and administrative costs (15,659) (22,873) Net Operating expenses (43,037) (66,041) Net Result from disposal
Slide 7: Income Statement: revenues
Income Statement: revenues 7 • Overall operating revenue increased 11.6% to €67.7 million • Royalties increased to € 20.2 million • Uceris royalties back to 2014 levels • Manufacturing of MMX® based products increased by 23.5% to € 35.9 million • Other contract drug manufacturing stable • Total Cons
Slide 8: Income Statement: costs
Income Statement: costs 8 • Operating costs € 23.0 million • Personnel expenses declined by € 10.9 million or 36.0% to €19.4 million • Average number of personnel increased by 14.5 persons; at year end headcount was 217 persons vs 183 last year • The cost reduction is due to the decrease in variable
Slide 9: Consolidated Statement of Financial Position
Consolidated Statement of Financial Position 9 EUR/1,000 31.12.2016 31.12.2015 Non current financial assets available for sale 71,984 127,088 Investments in associates 141,511 145,133 Other non current assets 42,905 27,792 Current financial assets available for sale 117,649 45,063 Cash, cash equival
Slide 10: Discussion of Statement of Financial Position
Discussion of Statement of Financial Position 10 • Total assets increased by 1.3% to € 443.5 million • Shift toward higher liquidity with current assets increasing by 35.6% to €187.1 million • Within current assets cash and cash equivalents increased by 65.1% to €117.6 million • 31.9% of total asset
Slide 11: Products on the market
11 Products on the market
Slide 12: Lialda/Mezavant/Mesavancol
® ® Lialda /Mezavant /Mesavancol® 12 • Indication is induction and maintenance of remission for patients with Ulcerative Colitis of mild to moderate severity • Net Sales of Lialda®/Mezavant® • 2015: $ 684 m (+8.6%) • 2016: $ 792 m (+15.8%) • Tablets manufactured • 2015: 285.7 m (+ 13.8%) • 2016: 315
Slide 13: Uceris - Cortiment
® Uceris - Cortiment® 13 • Indication • Induction of remission for patients with active Ulcerative Colitis of mild to moderate severity • Net Sales • 2014: $ 150 m • 2015: $ 108 m (de-stocking by Valeant after Salix acquisition) • 2016: $ 155 m • Cosmo Income • 2014: € 45.0 m (royalties of € 14.8 m;
Slide 14: Cortiment expansion plan
® Cortiment expansion plan 14 • Cortiment® is licensed to Ferring in all markets outside of US • Launched in 22 countries (+11) • approved in 42 countries (+8) • Pending registration in 18 countries (+4) • Submissions planned in 29 countries (+4)
Slide 15: New products
New products QCOsMo
Slide 16: Excellent trial results of LuMeBlue and Zemcolo and licensing in of Remimazolam
16 Excellent trial results of LuMeBlue and Zemcolo and licensing in of Remimazolam Give basis for a unique offering in the very large market of colonoscopies
Slide 17: Creating a unique offering in the colonoscopies mass market
17 Creating a unique offering in the colonoscopies mass market The pipeline fulfills three key objectives of endoscopy 1. See more and see better 2. Remove lesions safer and better 3. Make the procedure more efficient
Slide 18: The mass market of colonoscopies
18 The mass market of colonoscopies - 2018 16 million colonoscopies are projected to be performed in USA - 17-20 million in Europe - Potential for 60 million in RoW
Slide 19: LuMeBlue
19 LuMeBlue • Has successfully finished the phase III clinical trial • Full data released November 29, 2016 • Has shown statistical superiority versus white light HD endoscopy • Will vastly improve endoscopist’s performance • Consequently saves patients’ lives • Has no competition
Slide 20: Colonoscopy: standard of care
Colonoscopy: standard of care 20 What is the highest current standard of care in colonoscopies ? High Definition White Light Colonoscopy (“HDWL”) Requires sophisticated HD equipment and it is used in less than 20% of overall procedures ISSUES Adenoma Detection Rate (“ADR”) Even if using the best ava
Slide 21: ADR of individual endoscopists
3 21 18 endoscopists 3 462 colonoscopies ADR of There is a need to Individual narrow the range endoscopists of ADR detection rates
Slide 22: The more patients with adenoma are detected
1 22 The more patients Risk of interval cancer by endoscopists with adenoma are with low ADR detected…. HR 10 95% CI 1.4-87 The more cancer is prevented Risk of interval cancer by endoscopists with high ADR
Slide 23: For every 5% improvement in ADR
23 •For every 5% improvement in ADR: •11% reduction in CRC incidence Every year in USA: (95%CI, 10.3-11.9) - 149,000 CRC cases - 50,000 CRC deaths •13% reduction in CRC death (95%CI, 11.1-13.7) - 14$ billion •-3% cost due to saving in CRC treatment
Slide 24: Chromoendoscopy is recommended in IBD patients to enhance detection of neoplasias
Chromoendoscopy 24 According to the ASGE-ESGE, chromoendoscopy “is the topical application of stains or dyes at the time of endoscopy in an effort to enhance tissue characterization, differentiation, or diagnosis» Chromoendoscopy is recommended in IBD patients to enhance detection of neoplasias Howe
Slide 25: Improving the subjective skill of endoscopists in identifying dysplasia
Improving the subjective skill of 25 endoscopists in identifying dysplasia
Slide 26: FLAGS
26 Significantly enhances ADR substantially beyond HDWL and FLAGS lesions in an previously unseen, unrivalled fashion
Slide 27: Cimestue
Cimestue
Slide 28: A one-of-a-kind trial: placebo is the highest standard of care
A one-of-a-kind trial 28 In ordinary trials, placebo is generally water and sugar in our trial Placebo is the highest standard of care (HDWL) … performed and not only…. In some of the top hospitals by some of the top endoscopist in the world
Slide 29: A one-of-a-kind trial: Olympic champion example
A one-of-a-kind trial 29 As an example It is as taking the performance of an Olympic champion and making it SIGNIFICANTLY BETTER Increase his performance on 100m from 9.63s to 8.19s ? Can we do it ?
Slide 30: LuMeBlue is not a medical device but a fully fledged drug
A one-of-a-kind trial 30 LuMeBlue is not a medical device or a tool but a fully fledged drug. ® The LuMeBlue trial is the first multicenter and multinational trial in colonoscopy with extremely stringent requirements therefore raising the odds and hurdles but also the overall reliability of the resu
Slide 31: A one-of-a-kind trial: endpoints
A one-of-a-kind trial 31 Primary Endpoint Main Secondary Endpoints Proportion of subjects with at least one As of efficacy histologically proven Adenoma or Carcinoma • False positive rate • Proportion of subjects with at least one histologically proven Adenoma As of safety • Adverse events • Renal a
Slide 32: Extraordinary homogeneity between FAS and PP
32 Extraordinary homogeneity between FAS and PP, showing very few deviations and therefore increasing overall data reliability. PP shows the real efficacy of the treatment without major deviations. A large deviation between FAS and PP may mean that results are influenced by factors external to the p
Slide 33: LuMeBlue significantly enhances ADR in the full analysis set
33 LuMeBlue significantly enhances ADR in the full analysis set FAS HDWL 200 mg ADR 47.81% 56.29% Relative risk increase* 17.7% P-value 0.0099 Odds Ratio 1.41 [1.09, 1.81] *Calculated as (ADRLuMeBlue 200 mg / ADRHDWL) - 1
Slide 34: LuMeBlue False Positive Rate is better than HDWL
34 LuMeBlue False Positive Rate is >> better than HDWL critical requirement: False Positive Rate (FPR) versus HDWL Determining that LuMeBlue does not entice the endoscopist to remove lesions that are not proven to be adenomas (diagnostically, a False Positive). The Agencies, forecasted a higher numb
Slide 35: LuMeBlue decreases FPR by 14,4% vs HDWL
LuMeBlue FPR is significantly better 35 than HDWL Pts 356 Pts 326 LuMeBlue decreases FPR by 14,4% vs HDWL p-value: < 0,0001 FP 97 FP 83 Total LuMeBlue® pts : 485 Total HDWL pts : 479 FPR LuMeBlue FPR HDWL 23,3% 29,7%
Slide 36: LuMeBlue is clinically superior to HDWL in the most important segment of patients
36 LuMeBlue is clinically superior to HDWL in the most important segment of patients If adenomas are detected during colonoscopy, the subject will be referred to a next colonoscopy in a short time span ie 1-3 years If no adenomas are detected during colonoscopy, the subject will be referred to a nex
Slide 37: LuMeBlue efficacy greater in largest market segment
37 LuMeBlue efficacy has even greater diagnostic efficacy in largest market segment ADR IN OVERALL PTS POPULATION ADR IN PTS WITH EXCISION ≤ 3 HDWL 47.81 HDWL 35.9 LuMeBlue 56.29 LuMeBlue 45.3 RRI 17.7% RRI 26.2% 56.29 RRI 17.7 45.3 RRI 26.2 47.81 Pts 485 Pts 479 35.9 Pts 362 Pts 376 HDWL HDWL
Slide 38: LuMeBlue shows max diagnostic value increase in segment with 0-1 excision
LuMeBlue shows max diagnostic value increase 38 in the segment with 0 - 1 excision ADR IN OVERALL PTS POPULATION ADR IN PTS WITH EXCISION 0 - 1 HDWL 47.81 HDWL 18.94 LuMeBlue 56.29 LuMeBlue 26.18 RRI 17.7% RRI 38.2% 56.29 RRI 17.7 RRI 38.2 47.81 26.2 18.9 Pts 485 Pts 479 Pts 233 Pts 264 HDWL HDWL
Slide 39: LuMeBlue
LuMeBlue 39 Development status • Phase III completed, primary endpoint “proportion of subjects with at least one histologically proven Adenoma or Carcinoma” attained Timing • NDA Filing targeted for H1 2017 Business Development • Discussions for RoW licensing ongoing
Slide 40: Remove lesions safer and better
40 REMOVE LESIONS 2. SAFER and BETTER
Slide 41: The current standard: a hand-made saline solution application
The current standard: 41 a hand-made saline solution application
Slide 42: See the difference with Eleview?
See the difference with Eleview ? 42
Slide 43: Eleview market potential from additional indications
Eleview market potential from additional indications 43 The tissues of the esophagus, stomach and duodenum are similar to those of the colon Inspection of these conducted by Esophagogastroduodenoscopy (ECG) Eleview can be used in all these tracts As many ECGs are performed as colonoscopies, both in
Slide 44: Eleview development status
44 Development status • USA approved Marketing trials in four sites ongoing (speed and safety versus standard care in EMR) • EU Approved Timing • Targeted for launch in EU and USA in H1 2017 Business Development • Licensing process in EU and RoW ongoing
Slide 45: Make procedures more efficient: Remimazolam
45 REMIMAZOLAM 3. MAKE PROCEDURES MORE EFFICIENT
Slide 46: Cost bundling in USA
Cost bundling in USA 46 Incentive to make procedures as fast as possible Make them cheaper by reducing use of more costly personnel
Slide 47: Remimazolam is an ideal marketing complement to LuMeBlue and Eleview
Remimazolam is an ideal marketing complement to LuMeBlue and Eleview 47 Procedural sedation is used in practically all colonoscopies in the USA Market is split ~50%: 50% between propofol and midazolam Targeted to save costs Propofol use require presence/availability of an anaesthesist in the US As o
Slide 48: Times to reach sedation
48 Times to reach sedation Medians 25 Δ=15 min. Δ=15.5 min. Δ=15.5 min. 21.0 20 19.5 19.0 19.0 19.0 19.0 15 Minutes 10 5 4.0 3.5 3.5 0 Start Procedure MOAA/S 3 Peak Sedation S Remimazolam Placebo Midazolam 48
Slide 49: Time after end of procedure
49 Time after end of procedure End of procedure to fully alert 25 P<0.0001* 21.3 -39% 20 P<0.0001* Δ=222 min. -54% 15.7 15 Δ=8.5 min. Minutes 10 7.2 5 0 Remimazolam Placebo Midazolam Placebo *R vs. M: Anova F-test for equal means in 2 groups 49
Slide 50: Cosmo's pipeline goes beyond colonoscopies
50 Cosmo’s pipeline goes beyond colonoscopies After and expanding the unique position in GI
Slide 51: Zemcolo Project Rationale
Zemcolo Project Rationale 51 Zemcolo, broad spectrum, low toxicity, semi- MMX™ tablets synthetic, antibiotic, Very low levels of absorption when taken orally Ideal agent for the treatment of local infections control and in very common disorders as complementary to other drugs Addresses the entire co
Slide 52: Zemcolo shows a TLUS clearly shorter than placebo
Zemcolo: TD trials 52 Superiority vs placebo (Santarus) Distributions of Time to Last Unformed Stool (ITT Population) Zemcolo shows a TLUS clearly shorter than placebo
Slide 53: Zemcolo TD trials: superiority vs placebo outcome
Zemcolo: TD trials 53 Superiority vs placebo (Santarus) Outcome This is the first ever Results from this well- clinical trial in TD controlled Phase 3 study against placebo where demonstrate a favorable the drug has clearly benefit-to-risk profile shown a statistical for Zemcolo 400 mg significance
Slide 54: Zemcolo TD trials: non-inferiority vs Cipro
Zemcolo: TD trials 54 Non-inferiority vs Cipro (standard of care) (Falk) Outcome • The study clearly showed non-inferiority of Zemcolo vs Ciprofloxacin in terms of time to last unformed stool in TD • The secondary endpoints showed Zemcolo has similar efficacy vs Ciprofloxacin • Zemcolo is a very saf
Slide 55: Zemcolo: significant edge vs Cipro after FDA warning letter
Zemcolo: significant edge vs Cipro after 55 FDA issued a WARNING LETTER to Cipro Ciprofloxacin, because of its systemic absortion, has severe side effects and has just received an FDA warning letter Zemcolo, because of its colonic delivery, has practically no systemic absorption, thus practically no
Slide 56: Zemcolo: the way forward
Zemcolo: the way forward 56 1 – Travellers’ diarrhea is the simplest way to prove the antinfective property in GI and requires short treatment 2 – Other indications will be advantageously pursued with this anti-infective, anti-inflammatory drug: IBS and diverticulitis 3 – IBS and diverticulitis requ
Slide 57: Zemcolo: the way ahead, edge vs Xifaxan
Zemcolo: the way ahead 57 clear edge vs Xifaxan in anti-inflammatory properties ▪ Based on the EC50 values, Zemcolo is 100 times more potent than Rifampicin ▪ Zemcolo is at least 1000 times more potent than Rifaximin at stimulating PXR transcriptional activity in a cell line engineered to express a
Slide 58: Zemcolo: wrap-up
Zemcolo: wrap-up 58 In respect of potential competitors ▪ Compared to Xifaxan, Zemcolo allows antibiotic to be delivered directly to the colon, avoiding unwanted effects on the beneficial saprophytic bacterial flora living in the upper portions of the gastrointestinal tract ▪ Compared to Ciprofloxac
Slide 59: Zemcolo Development Plan
Zemcolo 59 Development Plan US (Cosmo) File NDA for TD in H1 2017 extend indication to: IBS D Development Timeline: Phase II DR in EU to start in H1 17 EU (licensed to Dr. Falk) File NDA for TD in H1 2017 Extend indication to: Uncomplicated Diverticulitis Development Timeline: Phase II P.O.C. ongoin
Slide 60: LuMeBlue, Remimazolam and Rifamycin unique product offering
60 LuMeBlue, Remimazolam and Rifamycin present a most compelling and unique product offering Are intertwined and can thus be efficiently marketed And are a compelling basis for establishing an own distribution organization that will allow a vast expansion
Slide 61: Allows Cosmo to capture the full value proposition
61 Allows Cosmo to capture the full value proposition Research Development Manufacturing Marketing Marketing Sales Sales
Slide 62: Aries Inc. US management team
62 • Leveraging on existing fruitful relationships, Cosmo has hired a US senior highly experienced management team located in San Diego • Aries Inc. management team has a specific expertise in marketing and distribution of GI drugs and pharmaceuticals products • Aries Inc. management team is incenti
Slide 63: Aries Pharmaceuticals structure
63 • Cosmo Pharmaceuticals NV is 100% owner of Aries Pharmaceuticals Ltd, Dublin • Aries Ltd is 100% holder of Aries Pharmaceuticals Inc., San Diego • Aries Ltd will market in the US under a license and supply agreement LuMeBlue, Eleview, Zemcolo and Remimazolam • Aries Pharmaceuticals Inc. will act
Slide 64: Aries Pharmaceuticals Inc. top management team
Aries Pharmaceuticals Inc. top management team 64 Tom Joyce – President & CEO From 2004 to 2014 Vice President, Marketing and National Accounts at Santarus. From 2014 to 2016 founder and partner of L.A.S. Partners, a health science consulting company focused on providing commercial insight and strat
Slide 65: Staffing Plan
Aries Inc. projected evolution of staff & salesforce 65 according to preliminary marketing plans Staffing Plan 2016 2017 2018 2019 Total 22 96 242 316 Thereof salespersons 0 45 145 205 Staffing may vary depending on launch timings
Slide 66: LuMeBlue US market research feed back
LuMeBlue US market research feed back 66 Number of non SSRI colonoscopies in 12’300’000 USA Suggested price $175 - $200 Expected US market entry Q3 2018
Slide 67: Eleview US market potential assessment
Eleview; US market potential assessment following market research 67 Number of colonoscopies in USA 16,000,000 Average number of adenomas found 2.31 per colonoscopy in phase III trial Adenomas extracted with saline 9% solution in phase III Number of vials used per adenoma 1.5 Foreseen price per vial
Slide 68: Outlook - Next strategic steps
Outlook - Next strategic steps 68 • Launch Eleview in USA • File NDAs for LuMeBlue & Zemcolo in USA • Find partners for LuMeBlue Eleview & Zemcolo in RoW • Potentially list Aries in due course • Further expand existing pipeline
Slide 69: Outlook - Financials
Outlook- Financials 69 • Historical revenues (CDM, Lialda, Uceris/Cortiment) of ~ € 70 million expected • Net operating ex USA expenses of ~ € 35/40 million expected in 2017 • Potential additional revenues from Eleview, LuMeBlue and Zemcolo licensing
Slide 70: Cosmo Pharmaceuticals
Cosmo Pharmaceuticals 70 Information Contacts •Number of shares: 14,418,983 • Alessandro Della Cha , CEO [email protected] •Listing: SIX Swiss exchange, Main board • Luigi Moro, CSO [email protected] •ISIN: NL0011832936 • Niall Donnelly, CFO [email protected] • Giuseppe Cipriano,